0001193125-20-326928 | S-1/A | XBRL Viewer

Business Description and Basis of Presentation [Text Block]

A.	Description of Business and Basis of Presentation

Organization

KemPharm, Inc. (the “Company”) is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary Ligand Activated Therapy (“LAT^®”) technology. The Company utilizes its proprietary LAT technology to generate improved prodrug versions of U.S. Food and Drug Administration (the “FDA”) approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. The Company’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder (“ADHD”) and stimulant use disorder (“SUD”). The Company’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, the Company has received FDA approval for APADAZ^®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and related notes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included in the accompanying financial statements. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2020.

This interim information should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 28, 2020, as amended on April 8, 2020 (the “Annual Report”).

Reverse Stock Split

On December 23, 2020, the Company completed a one-for-sixteen reverse stock split (the “Reverse Stock Split”), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $0.0001 per share. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise held fractional shares of the Company’s common stock as a result of the Reverse Stock Split will receive a cash payment in lieu of such fractional shares. Except where disclosed, all amounts related to number of shares and per share amounts have been retroactively restated in these unaudited condensed financial statements.

Going Concern

The unaudited condensed financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The Company has experienced recurring negative operating cash flows and has a stockholders’ deficit and net working capital (current assets less current liabilities) deficit, and its existing cash and cash equivalents and restricted cash are not sufficient to fund the Company’s operating expenses and capital expenditure requirements for at least one year from the date these unaudited condensed financial statements are issued. Various internal and external factors will affect whether and when product candidates become approved drugs and how significant the market share of those approved products will be. The length of time and cost of developing and commercializing these product and product candidates and/or failure of them at any stage of the drug approval or commercialization process will materially affect the Company’s financial condition and future operations. In order to continue as a going concern, the Company will need additional financing to fund its operations. The perception of the Company’s inability to continue as a going concern may make it more difficult to obtain financing for the continuation of operations and could result in the loss of confidence by investors, suppliers and employees. Adequate additional financing may not be available to the Company on acceptable terms, or at all.

Management believes these conditions raise substantial doubt about the Company’s ability to continue as a going concern within the twelve months after the date these unaudited condensed financial statements are issued. Based upon the Company’s current operating plan and projected revenues, the Company believes its cash resources, including the funds received through the Payroll Protection Program (“PPP”) (discussed below) will be sufficient to fund operating expense and capital investment requirements past the potential March 2, 2021 Prescription Drug User Fee Act (“PDUFA”) date for the KP415 New Drug Application (“NDA”) and up to the debt maturity date of March 31, 2021. The ability to continue as a going concern is dependent upon profitable future operations, positive cash flows, the forbearance of the Company’s lenders and additional financing. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.

In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of Coronavirus, a global pandemic. This outbreak is causing major disruptions to businesses and markets worldwide as the virus spreads. The Company cannot predict what the long-term effects of this pandemic and the resulting economic disruptions may have on the Company’s liquidity and results of operations. The extent of the effect of the COVID-19 pandemic on the Company’s liquidity and results of operations will depend on a number future developments, including the duration, spread and intensity of the pandemic, and governmental, regulatory and private sector responses, all of which are uncertain and difficult to predict. The COVID-19 pandemic may make it more difficult for the Company to enroll patients in any future clinical trials or cause delays in the regulatory approval of the Company’s product candidates, including causing potential delay of the FDA’s review of the Company’s KP415 NDA. A portion of the Company’s projected revenue is based upon the achievement of milestones in the KP415 License Agreement (as defined below) associated with regulatory matters that may be impacted by the COVID-19 pandemic. As a result, the Company cannot predict what, if any, impact that the COVID-19 pandemic may have on the Company’s ability to achieve these milestones. The economic uncertainty surrounding the COVID-19 pandemic may also dramatically reduce the Company’s ability to secure debt or equity financing necessary to support the Company’s operations. The Company is unable to currently estimate the financial effect of the pandemic. If the pandemic continues to be a severe worldwide crisis, it could have a material adverse effect on the Company’s business, results of operations, financial condition, and cash flows. The financial statements do not reflect any adjustments as a result of the COVID-19 pandemic.

On April 23, 2020 the Company received proceeds of $0.8 million from a loan (the “PPP Loan”) under the PPP of the recently enacted Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), a portion of which may be forgiven, which the Company used to retain current employees, maintain payroll and make lease and utility payments. The PPP Loan matures on April 23, 2022 and bears annual interest at a rate of 1.0%. Payments of principal and interest on the PPP Loan were originally deferred for the first six months of the PPP Loan term. Thereafter, the Company would have been required to pay the lender equal monthly payments of principal and interest. Refer to Note C for a further discussion of the PPP Loan.

Entry into Prior Purchase Agreement

In February 2019, the Company entered into a purchase agreement (the “Prior Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company previously could sell to Lincoln Park up to $15.0 million of shares of common stock from time to time over the 36-month term of the Prior Purchase Agreement, and upon execution of the Prior Purchase Agreement the Company issued an additional 7,512 shares of common stock to Lincoln Park as commitment shares in accordance with the closing conditions within the Prior Purchase Agreement. Concurrently with entering into the Prior Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park (the “Prior Registration Rights Agreement”) pursuant to which the Company agreed to register the sale of the shares of common stock that have been and may be issued to Lincoln Park under the Prior Purchase Agreement pursuant to the Company’s existing shelf registration statement on Form S-3 or a new registration statement. The Prior Purchase Agreement was terminated in February 2020 in connection with entering into the Current Purchase Agreement (discussed below). Prior to the termination of the Prior Purchase Agreement, the Company sold 212,579 shares of common stock to Lincoln Park (exclusive of the 7,512 commitment shares) under the Prior Purchase Agreement for approximately $5.4 million in gross proceeds.

Entry into Current Purchase Agreement

In February 2020, the Company entered into a purchase agreement (the “Current Purchase Agreement”) with Lincoln Park which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $4.0 million of shares of common stock from time to time over the 12-month term of the Current Purchase Agreement, and upon execution of the Current Purchase Agreement the Company issued an additional 19,289 shares of common stock to Lincoln Park as commitment shares in accordance with the closing conditions within the Current Purchase Agreement. Concurrently with entering into the Current Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park (the “Current Registration Rights Agreement”) pursuant to which the Company agreed to register the sale of the shares of common stock that have been and may be issued to Lincoln Park under the Current Purchase Agreement pursuant to the Company’s existing shelf registration statement on Form S-3 or a new registration statement. In May 2020, the Company reached the maximum allowable shares to be issued under the Current Registration Statement of 579,260 shares (inclusive of the 19,289 commitment shares) as defined in Section 2(f)(i) of the Current Purchase Agreement and therefore cannot issue additional shares under the Current Purchase Agreement. As of September 30, 2020, the Company has sold 559,971 shares of common stock to Lincoln Park (exclusive of the 19,289 commitment shares) under the Current Purchase Agreement for approximately $2.3 million in gross proceeds.

Entry into APADAZ License Agreement

In October 2018, the Company entered into a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”) pursuant to which we have granted an exclusive license to KVK to conduct regulatory activities for, manufacture and commercialize APADAZ in the United States.

Pursuant to the APADAZ License Agreement, KVK agreed to pay the Company certain payments and cost reimbursements of an estimated $3.4 million, which includes a payment of $2.0 million within 10 days of the achievement of a specified milestone related to the initial formulary adoption of APADAZ (the “Initial Adoption Milestone”). In addition, KVK has agreed to make additional payments to the Company upon the achievement of specified sales milestones of up to $53.0 million in the aggregate. Further, the Company and KVK will share the quarterly net profits of APADAZ by KVK in the United States at specified tiered percentages, ranging from the Company receiving 30% to 50% of net profits, based on the amount of net sales on a rolling four quarter basis. The Company is responsible for a portion of commercialization and regulatory expenses for APADAZ until the Initial Adoption Milestone is achieved, after which KVK will be responsible for all expenses incurred in connection with commercialization and maintaining regulatory approval in the United States.

The APADAZ License Agreement will terminate on the later of the date that all of the patent rights for APADAZ have expired in the United States or KVK’s cessation of commercialization of APADAZ in the United States. KVK may terminate the APADAZ License Agreement upon 90 days written notice if a regulatory authority in the United States orders KVK to stop sales of APADAZ due to a safety concern. In addition, after the third anniversary of the APADAZ License Agreement, KVK may terminate the APADAZ License Agreement without cause upon 18 months prior written notice. The Company may terminate the APADAZ License Agreement if KVK stops conducting regulatory activities for or commercializing APADAZ in the United States for a period of six months, subject to specified exceptions, or if KVK or its affiliates challenge the validity, enforceability or scope of any licensed patent under the APADAZ License Agreement. Both parties may terminate the APADAZ License Agreement (i) upon a material breach of the APADAZ License Agreement, subject to a 30-day cure period, (ii) if the other party encounters bankruptcy or insolvency or (iii) if the Initial Adoption Milestone is not achieved. Upon termination, all licenses and other rights granted by the Company to KVK pursuant to the APADAZ License Agreement would revert to the Company.

The APADAZ License Agreement also established a joint steering committee, which monitors progress of the commercialization of APADAZ.

Entry into KP415 License Agreement

In September 2019, the Company entered into a Collaboration and License Agreement (the “KP415 License Agreement”) with Commave Therapeutics SA, an affiliate of Gurnet Point Capital (“Commave”). Under the KP415 License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing serdexmethylphenidate (“SDX”) and d-methylphenidate (“d-MPH”), including KP415, KP484, and, at the option of Commave, KP879, KP922 or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other central nervous system disorder (the “Additional Product Candidates” and, collectively with KP415 and KP484, the “Licensed Product Candidates”). Pursuant to the KP415 License Agreement, Commave (i) paid the Company an upfront payment of $10.0 million; (ii) agreed to pay milestone payments of up to $63.0 million upon the occurrence of specified regulatory milestones related to the KP415 and KP484; (iii) agreed to pay additional payments of up to $420.0 million upon the achievement of specified U.S. sales milestones; and (iv) has agreed to pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to the mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the United States and a percentage in the low to mid-single digits of Net Sales in each country outside the United States, in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement. Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the Royalty Term (as defined in the KP415 License Agreement) for the applicable product.

In May 2020, the FDA accepted the Company’s NDA for KP415. Per the KP415 License Agreement, the Company received a regulatory milestone payment of $5.0 million following the FDA’s acceptance of the KP415 NDA.

Commave has also agreed to be responsible and reimburse the Company for all of development, commercialization and regulatory expenses for the Licensed Product Candidates, subject to certain limitations as set forth in the KP415 License Agreement.

The KP415 License Agreement also established a joint steering committee, which monitors progress of the development of both KP415 and KP484. Subject to the oversight of the joint steering committee, the Company otherwise retains all responsibility for the conduct of all regulatory activities required to obtain new drug application approval of KP415 and KP484; provided that Commave shall be the sponsor of any clinical trials conducted by the Company on behalf of Commave.

In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics (formerly known as MonoSol Rx, LLC), Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to KP415, KP484 or KP879 under the KP415 License Agreement.

A.	Description of Business and Basis of Presentation

Organization

KemPharm, Inc. (the “Company”) is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary Ligand Activated Therapy (“LAT^™”) technology. The Company utilizes its proprietary LAT technology to generate improved prodrug versions of U.S. Food and Drug Administration (the “FDA”) approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. The Company’s product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder (“ADHD”) and stimulant use disorder (“SUD”). The Company’s clinical product candidates for the treatment of ADHD include KP415 and KP484, and the Company’s preclinical product candidate for the treatment of SUD includes KP879. The Company was formed and incorporated in Iowa in October 2006 and reorganized in Delaware in May 2014.

Reverse Stock Split

Going Concern

The financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The Company has experienced recurring negative operating cash flows and has a stockholders’ deficit, and its existing cash and cash equivalents and restricted cash are not sufficient to fund the Company’s operating expenses and capital expenditure requirements for at least one year from date these financial statements are issued. Various internal and external factors will affect whether and when product candidates become approved drugs and how significant the market share of those approved products will be. The length of time and cost of developing and commercializing these product and product candidates and/or failure of them at any stage of the drug approval or commercialization process will materially affect the Company’s financial condition and future operations. The Company’s ability to continue as a going concern will likely need additional financing to fund its operations. The perception of the Company’s inability to continue as a going concern may make it more difficult to obtain financing for the continuation of operations and could result in the loss of confidence by investors, suppliers and employees. Adequate additional financing may not be available to the Company on acceptable terms, or at all.

Management believes these conditions raise substantial doubt about the Company’s ability to continue as a going concern within the twelve months after the date these financial statements are issued. Based upon the Company’s current operating plan and projected revenue, the Company believes its cash resources will be sufficient to fund operating expense and capital investment requirements into, but not through, the first quarter of 2021. A significant portion of the Company’s projected revenue is based upon the achievement of milestones in the KP415 and APADAZ license agreements. Certain of the milestones are associated with regulatory matters that are outside the control of the Company and the Company does not have a history of achieving milestones in their license agreements. If revenues are not as the Company projects, the Company believes its existing resources are sufficient to fund its current operations into but not through the third quarter of 2020. The ability to continue as a going concern is dependent upon profitable future operations, positive cash flows, the forbearance of the Company’s lenders and additional financing. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Management intends to finance operating costs over the next twelve months with existing cash and cash equivalents and restricted cash, as well as anticipated payments arising from the Company’s license agreements and additional financing through the Company’s active registration statement on Form S-3 covering the sale of up to $150.0 million of the Company’s common stock, preferred stock, and debt and/or warrants, if available (the “Current Registration Statement”). In October 2019, the Company filed a registration on Form S-3 covering the sale of up to $80.0 million of the Company’s common stock, preferred stock, and debt and/or warrants (the “Replacement Registration Statement”). Once the Replacement Registration Statement is declared effective by the SEC, the Company will no longer make any sales under the Current Registration Statement.

After the Company files this Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “Annual Report”), in order to issue securities under the Current Registration Statement or the Replacement Registration Statement, once effective, it must rely on Instruction I.B.6. of Form S-3, which imposes a limitation on the maximum amount of securities that the Company may sell pursuant to the registration statements during any twelve-month period. At the time it sells securities pursuant to the applicable registration statement, the amount of securities to be sold plus the amount of any securities it has sold during the prior twelve months in reliance on Instruction I.B.6. may not exceed one-third of the aggregate market value of its outstanding common stock held by non-affiliates as of a day during the 60 days immediately preceding such sale, as computed in accordance with Instruction I.B.6. As of filing this Annual Report, based on this calculation, the amount of securities the Company is able to sell under a registration statement on Form S-3 is approximately $10.9 million, of which the Company (i) has filed a prospectus supplement to register approximately $4.0 million for sales under the Purchase Agreement (as defined below); and (ii) has previously sold an aggregate of $5.7 million of shares of common stock in prior offering on Form S-3 in the previous 12 months. Based on this calculation, the Company expects it will be unable to sell additional securities beyond those amounts pursuant to the Current Registration Statement or the Replacement Registration Statement, once effective, in the near term, unless and until the market value of its outstanding common stock held by non-affiliates increases significantly. In addition, under the terms of the Purchase Agreement, stockholder approval may be required to access a portion of the amounts available under the Purchase Agreement. As of December 31, 2019, the Company has sold 212,579 shares of common stock registered under the Current Registration Statement for approximately $5.4 million in gross proceeds under the Prior Purchase Agreement.

Entry into First ATM Agreement

In October 2016, the Company entered into a Common Stock Sales Agreement (the “First ATM Agreement”) with Cowen and Company, LLC (“Cowen”). The First ATM Agreement was terminated in September 2018. Prior to termination of the First ATM Agreement, the Company sold an aggregate of 47,638 shares of common stock under the First ATM Agreement resulting in gross proceeds to the Company of $4.9 million. The Company paid Cowen a commission of up to three percent (3.0%) of the gross sales proceeds for such sales of common stock. Pursuant to the terms of the First ATM Agreement, specified obligations of the parties, including the Company’s indemnification obligations to Cowen, survive the termination of the First ATM Agreement.

Entry into Second ATM Agreement

In September 2018, the Company entered into a Common Stock Sales Agreement (the “Second ATM Agreement”) with RBC Capital Markets, LLC (“RBCCM”) under which the Company may offer and sell, from time to time, in its sole discretion, shares of common stock having an aggregate offering price of up to $50,000,000 through RBCCM as its sales agent. The Company’s registration statement on Form S-3 contemplated under the Second ATM Agreement was declared effective by the SEC on October 17, 2016. The registration statement on Form S-3 includes a prospectus supplement covering the offering of up to $50,000,000 of shares of common stock in accordance with the Second ATM Agreement. In March 2019, the Company filed an updated prospectus supplement regarding the Second ATM Agreement covering the offering of up to $3.2 million of shares of common stock in order to be in compliance with Instruction I.B.6 of Form S-3. In February 2020, the Company terminated this offering. As of December 31, 2019, the Company has not sold any shares of common stock under the Second ATM Agreement.

Underwritten Public Offering

In October 2018, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBCCM, pursuant to which, on October 10, 2018, the Company sold 520,833 shares of common stock of the Company in an underwritten public offering pursuant to the Company’s registration statement on Form S-3, filed with the SEC on October 17, 2016, and a related prospectus and prospectus supplement, filed with the SEC on October 17, 2016 and October 5, 2018, respectively. The offering price to the public was $48.00 per share. The Company’s net proceeds from the offering were approximately $23.1 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Entry into Prior Purchase Agreement

In February 2019, the Company entered into a purchase agreement (the “Prior Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company previously could sell to Lincoln Park up to $15.0 million of shares of common stock from time to time over the 36-month term of the Prior Purchase Agreement, and upon execution of the Prior Purchase Agreement the Company issued an additional 7,512 shares of common stock to Lincoln Park as commitment shares in accordance with the closing conditions within the Prior Purchase Agreement. Concurrently with entering into the Prior Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park pursuant to which the Company agreed to register the sale of the shares of common stock that have been and may be issued to Lincoln Park under the Prior Purchase Agreement pursuant to the Company’s existing shelf registration statement on Form S-3 or a new registration statement. As of December 31, 2019, the Company has sold 212,579 shares of common stock to Lincoln Park under the Prior Purchase Agreement for approximately $5.4 million in gross proceeds. In February 2020, and in connection with entering into the Purchase Agreement (see discussion below), the Company terminated the Prior Purchase Agreement.

Entry into APADAZ License Agreement

The APADAZ License Agreement will terminate on the later of the date that all of the patent rights for APADAZ have expired in the United States or KVK’s cessation of commercialization of APADAZ in the United States. KVK may terminate the APADAZ License Agreement upon 90 days written notice if a regulatory authority in the United States orders KVK to stop sales of APADAZ due to a safety concern. In addition, after the third anniversary of the APADAZ License Agreement, KVK may terminate the APADAZ License Agreement without cause upon 18 months prior written notice. The Company may terminate the APADAZ License Agreement if KVK stops conducting regulatory activities for or commercializing APADAZ in the United States for a period of six months, subject to specified exceptions, or if KVK or its affiliates challenge the validity, enforceability or scope of any licensed patent under the APADAZ License Agreement. Both parties may terminate the APADAZ License Agreement (i) upon a material breach of the APADAZ License Agreement, subject to a 30-day cure period, (ii) the other party encounters bankruptcy or insolvency or (iii) if the Initial Adoption Milestone is not achieved. Upon termination, all licenses and other rights granted by the Company to KVK pursuant to the APADAZ License Agreement would revert to the Company.

The APADAZ License Agreement also established a joint steering committee, which monitors progress of the commercialization of APADAZ.

Entry into KP415 License Agreement

Entry into Purchase Agreement

In February 2020, the Company entered into a purchase agreement with Lincoln Park (the “Purchase Agreement”), which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $4.0 million of shares of its common stock, from time to time over the 12-month term of the Purchase Agreement, and upon execution of the Purchase Agreement the Company issued an additional 19,289 shares of its common stock to Lincoln Park as commitment shares in accordance with the closing conditions contained within the Purchase Agreement. Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park, pursuant to which the Company agreed to register the sale of the shares of its common stock that have been and may be issued to Lincoln Park under the Purchase Agreement pursuant to the Company’s existing shelf registration statement on Form S-3 or a new registration statement.

Summary of Significant Accounting Policies

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Significant Accounting Policies [Text Block]

B.	Summary of Significant Accounting Policies

Use of Estimates

The preparation of unaudited condensed financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the unaudited condensed financial statements and accompanying notes. Actual results could differ from those estimates.

On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities.

Revenue Recognition

The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers (“ASC 606”), starting January 1, 2018. However, the Company had no revenue until the third quarter of 2019.

Arrangements with Multiple-Performance Obligations

From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, consulting fees and/or profit sharing.

In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available.

The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. Should there be royalties, the Company utilizes the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur.

Licensing Agreements

The Company enters into licensing agreements with licensees that fall under the scope of ASC 606.

The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues.

As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

Up-front Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time.

Milestone Payments: At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative licensing revenues and earnings in the period of adjustment.

KP415 License Agreement

In September 2019, the Company entered into the KP415 License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, including KP415, KP484, and, at the option of Commave, KP879, KP922 and/or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other central nervous system disorder. The license granted to Commave is distinct from other performance obligations as Commave can benefit from the license either on its own or together with other resources that are readily available and the license is separately identifiable from other promises in the KP415 License Agreement.

In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront payment of $10.0 million. The Company is also entitled to additional payments from Commave of up to $63.0 million, conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484. In May 2020, the FDA accepted the Company’s NDA for KP415. Per the KP415 License Agreement, the Company received a regulatory milestone payment of $5.0 million following the FDA’s acceptance of the KP415 NDA. In addition, the Company is entitled to payments from Commave of up to $420.0 million in the aggregate, conditioned upon the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement

Commave also agreed to be responsible for and reimburse the Company for all of development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products.

The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations at inception. The Company further determined that the transaction price, at inception, under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the KP415 License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price.

The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the KP415 License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the KP415 License Agreement.

The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, was the fair value of the Development Costs (as defined in the KP415 License Agreement), which reflects the standalone selling price. The Company utilized a blended approach which took into consideration the adjusted market assessment approach and the expected cost plus a margin approach to determine this standalone selling price. This blended approach utilized the adjusted market approach and expected cost plus margin approach to value the performance of consulting services which included analyzing hourly rates of vendors in the a market who perform similar services to those of the Company to develop a range and then analyzing the average cost per hour of our internal resources and applying a margin which placed the value in the median of the previously identified range. For the reimbursement of out-of-pocket third-party research and development costs the Company utilized the expected cost plus a margin approach, which included estimating the actual out-of-pocket cost the Company expects to pay to third-parties for research and development costs and applying a margin, if necessary. The Company determined that no margin was necessary of these out-of-pocket third-party research and development costs as these are purely pass-through costs and the margin for managing these third-party activities is included within the value of the performance of consulting services. The Company determined that the performance of consulting services, including reimbursement of out-of-pocket third-party research and development costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable out-of-pocket third-party research and development costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As discussed above, the combination of the standalone selling price of these consulting services and certain out-of-pocket third-party research and development costs for KP415 was the fair value of the Development Costs at inception. These Development Costs effectively created a cap on certain consulting services and out-of-pocket third-party research and development costs identified in the initial product development plan for KP415 which was anticipated at the inception date of the KP415 License Agreement. As of September 30, 2020, the Company has recognized all of the consulting services and out-of-pocket third-party research and development costs under this cap.

Under the KP415 License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the KP415 License Agreement) under the KP415 License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a right of first refusal (“ROFR”) to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates.

The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal.

For example, in May 2020, the FDA accepted the Company’s NDA for KP415. Per the KP415 License Agreement, the Company received a regulatory milestone payment of $5.0 million following the FDA’s acceptance of the KP415 NDA. Since the FDA accepted the Company’s NDA for KP415 the constraint was removed and revenue recognized. The associated revenue was allocated among the two performance obligations identified at contract inception. Since both performance obligations were satisfied as of the end of the second quarter of 2020 the full $5.0 million payment was recognized as revenue during the second quarter of 2020.

For the three and nine months ended September 30, 2020, the Company recognized revenue under the KP415 License Agreement of $0 and $7.3 million, respectively. In accordance with the guidance provided in ASC 340-40, Contracts with Customers, the Company capitalized approximately $2.8 million of incremental costs incurred in obtaining the KP415 License Agreement and will amortize these costs as the revenue associated with the exclusive worldwide license, reimbursement of out-of-pocket third-party research and development costs and consulting services is recognized. As of September 30, 2020, the Company has recognized all of these incremental costs, $0 and $0.8 million of which was recognized in the three and nine months ended September 30, 2020, respectively, and are recorded in the line item titled royalty and direct contract acquisition costs in the unaudited condensed statement of operations. There was $11.5 million of revenue and $1.0 million of associated direct contract acquisition costs recognized for the three and nine months ended September 30, 2019 related to the KP415 License Agreement. There was no deferred revenue related to this agreement as of September 30, 2020 or December 31, 2019.

Consulting Arrangements

From time to time, the Company enters into consulting arrangements with third-parties to provide research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket third-party research and development, regulatory and commercial costs.

Corium Consulting Agreement

In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of KP415 (together, “Corium Consulting Services”). Corium is a portfolio company of Gurnet Point Capital and has been tasked with leading all commercialization activities for KP415 under the KP415 License Agreement, as discussed above.

Under the Corium Consulting Agreement, the Company is entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which will be paid in quarterly installments through March 31, 2022. The remaining $2.0 million is conditioned upon the achievement of a specified regulatory milestone related to Corium’s product portfolio. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services.

The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. Using the concepts of ASC 606, the Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone is constrained by considering both the likelihood and magnitude of the potential revenue reversal.

The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of September 30, 2020, the Company has recognized approximately 15% of the consulting services and third-party pass-through costs under the Corium Consulting Agreement.

For the three and nine months ended September 30, 2020, the Company recognized revenue under the Corium Consulting Agreement of $1.9 million. There was no revenue recognized for the three and nine months ended September 30, 2019 related to the Corium Consulting Agreement. As of September 30, 2020, the Company had deferred revenue related to this agreement of $0.1 million. There was no deferred revenue related to this agreement as of December 31, 2019 as it was not entered into until July 2020.

Other Consulting Arrangements

For the three and nine months ended September 30, 2020, the Company recognized revenue under other consulting arrangements of $0 and $1.7 million, respectively. There was no revenue recognized from other consulting arrangements for the three and nine months ended September 30, 2019. There was no deferred revenue from other from consulting arrangements as of September 30, 2020 or December 31, 2019.

Accounts and Other Receivables

Accounts and other receivables consists of receivables under the KP415 License Agreement and Corium Consulting Agreement, as well as receivables related to other consulting arrangements, income tax receivables and other receivables due to the Company. Receivables under the KP415 License Agreement and Corium Consulting Agreement are recorded for amounts due to the Company related to reimbursable third-party costs and performance of consulting services. These receivables, as well as the receivables related to other consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date. As of September 30, 2020, the Company had receivables related to the Corium Consulting Agreement in the amount of $2.0 million and no receivables related to the KP415 License Agreement or other consulting arrangements. As of December 31, 2019, the Company had receivables related to the KP415 License Agreement in the amount of $1.6 million and receivables related to other consulting arrangements of $0.1 million. As of September 30, 2020 and December 31, 2019 no reserve or allowance for doubtful accounts has been established.

Application of New or Revised Accounting Standards—Adopted

From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date.

In April 2012, President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later than public companies must adopt the standards. The Company has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act and, as a result, will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which replaces the incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This update applies to all entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off-balance-sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The adoption of ASU 2016-13 did not have a material impact on the Company’s financial statements and disclosures.

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the FASB Concepts Statement, Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, which the FASB finalized on August 28, 2018, including the consideration of costs and benefits. This update applies to all entities that are required, under existing GAAP, to make disclosures about recurring or nonrecurring fair value measurements. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The adoption of ASU 2018-13 did not have a material impact on the Company’s financial statements and disclosures.

Application of New or Revised Accounting Standards—Not Yet Adopted

In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40); Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which addresses issues identified as a result of the complexities associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This update addresses, among other things, the number of accounting models for convertible debt instruments and convertible preferred stock, targeted improvements to the disclosures for convertible instruments and earnings-per-share (“EPS”) guidance and amendments to the guidance for the derivatives scope exception for contracts in an entity’s own equity, as well as the related EPS guidance. This update applies to all entities that issue convertible instruments and/or contracts in an entity’s own equity. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. FASB specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The Company is currently evaluating the impact the adoption of ASU 2020-06 could have on the Company’s financial statements and disclosures.

B.	Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

Reclassifications

During 2019, the Company began presenting accounts and other receivables as a separate line item on the balance sheets and statements of cash flows. In prior periods, accounts and other receivables were reported within the prepaid expenses and other current assets line items in the balance sheets and statements of cash flows. In accordance with GAAP, the change in current period presentation requires a reclassification of prior period balances. The reclassification of prior period balances resulted in a reduction of prepaid expenses and other current assets of $0.1 million on the Company’s balance sheet for the period ended December 31, 2018 and a reduction in change in prepaid expenses and other assets of $0.1 million on the statement of cash flows for the year ended December 31, 2018. This reclassification had no effect on the statements of operations.

Concentration of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit with multiple financial institutions, the balances of which frequently exceed insured limits.

Cash and Cash Equivalents

The Company considers any highly liquid investments with an original maturity of three months or less to be cash equivalents.

Marketable Securities and Long-term Investments

The Company maintained investment securities that were classified as trading securities. These securities were carried at fair value with unrealized gains and losses included in other (expense) income on the statements of operations. The securities primarily consisted of certificates of deposit, U.S. Treasury securities and U.S. government-sponsored agency securities.

Property and Equipment

The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to ten years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation and amortization are removed from the accounts with the resulting gains or losses, if any, reflected in the statements of operations.

Debt Issuance Costs

Debt issuance costs incurred in connection with financing arrangements are recorded as a reduction of the related debt on the balance sheet and amortized over the life of the respective financing arrangement using the effective interest method.

Supply Arrangements

The Company enters into supply arrangements for the supply of components of its product and product candidates. These arrangements also may include a share of future revenue if related product or product candidates reach commercialization. Costs under these supply arrangements, if any, are expensed as incurred (Note I).

Impairment of Long-Lived Assets

Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying values, an impairment loss is recorded for the difference between the carrying values and fair values of the asset. No such impairment occurred for the years ended December 31, 2019 or 2018.

Fair Value of Financial Instruments

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.

The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows:

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Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;

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Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and

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Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

Revenue Recognition

Arrangements with Multiple-Performance Obligations

Licensing Agreements

The Company enters into licensing agreements with licensees that fall under the scope of ASC 606.

KP415 License Agreement

In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront payment of $10.0 million. The Company is also entitled to additional payments from Commave of up to $63.0 million, conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484. In addition, the Company is entitled to payments from Commave of up to $420.0 million in the aggregate, conditioned upon the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement

The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company has identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations. The Company further determined that the transaction price under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the KP415 License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price.

The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, was the fair value of the Development Costs (as defined in the KP415 License Agreement), which reflects the standalone selling price. The Company utilized a blended approach which took into consideration the adjusted market assessment approach and the expected cost plus a margin approach to determine this standalone selling price. This blended approach utilized the adjusted market approach and expected cost plus margin approach to value the performance of consulting services which included analyzing hourly rates of vendors in the a market who perform similar services to those of the Company to develop a range and then analyzing the average cost per hour of our internal resources and applying a margin which placed the value in the median of the previously identified range. For the reimbursement of out-of-pocket third-party research and development costs the Company utilized the expected cost plus a margin approach, which included estimating the actual out-of-pocket cost the Company expects to pay to third-parties for research and development costs and applying a margin, if necessary. The Company determined that no margin was necessary of these out-of-pocket third-party research and development costs as these are purely pass-through costs and the margin for managing these third-party activities is included within the value of the performance of consulting services. The Company determined that the performance of consulting services, including reimbursement of out-of-pocket third-party research and development costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable out-of-pocket third-party research and development costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As discussed above, the combination of the standalone selling price of these consulting services and certain out-of-pocket third-party research and development costs for KP415 was the fair value of the Development Costs at inception. These Development Costs effectively created a cap on certain consulting services and out-of-pocket third-party research and development costs identified in the initial product development plan for KP415 which was anticipated at the inception date of the KP415 License Agreement. As of December 31, 2019, the Company has recognized approximately 66% of the consulting services and out-of-pocket third-party research and development costs under this cap.

The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal.

For the year ended December 31, 2019, the Company recognized revenue of $12.8 million, which is comprised of a $10.0 million non-refundable payment for an exclusive, worldwide license, $1.1 million of reimbursement of out-of-pocket third-party research and development costs and $1.7 million for the performance of consulting services. In addition, as of December 31, 2019, the Company had receivables in the amount of $1.4 million and $0.2 million related to the performance of consulting services and the reimbursement of out-of-pocket third-party research and development costs, respectively. In connection with the $10.0 million non-refundable payment the Company received under the KP415 License Agreement, the Company paid Aquestive Therapeutics a royalty equal to 10% of the upfront license payment received in the third quarter of 2019. In addition, under the guidance provided in ASC 340-40, Contracts with Customers, the Company capitalized approximately $2.8 million of incremental costs incurred in obtaining the KP415 License Agreement and will amortize these costs as the revenue associated with the exclusive worldwide license, reimbursement of out-of-pocket third-party research and development costs and consulting services is recognized. As of December 31, 2019, the Company has recognized approximately $1.9 million of these incremental costs, which are recorded in the line item titled royalties and contract costs in the statement of operations along with the royalty discussed above. The remaining incremental contract costs to be amortized are recorded in prepaid expense and other currents on the balance sheet. There was no revenue recognized, or associated receivables and cost revenue, for the year ended or as of December 31, 2018. There was no deferred revenue related to this agreement as of December 31, 2019 or 2018.

Accounts and Other Receivables

Accounts and other receivables consists of receivables under the KP415 License Agreement, as well as income tax and other receivables due to the Company. Receivables under the KP415 License Agreement are recorded for amounts due to the Company related to reimbursable out-of-pocket third-party research and development costs and performance of consulting services. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. As of December 31, 2019 and 2018 no reserve or allowance has been established.

Research and Development

Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred.

The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as the Company receives the related goods or services.

The Company enters into contractual agreements with third-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of the service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of the accrued expenses as of each balance sheet date based on the facts and circumstances known. The Company periodically confirms the accuracy of the estimates with the service providers and make adjustments, if necessary.

Patent Costs

Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations.

Income Taxes

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely than not to be realized.

Uncertain tax positions are recognized only when the Company believes it is more likely than not that the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense. The Company did not have any accrued interest or penalties associated with uncertain tax positions as of December 31, 2019 and 2018.

The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal and state and local income tax examinations for years prior to 2014, although carryforward attributes that were generated prior to 2014 may still be adjusted upon examination by the Internal Revenue Service if used in a future period. No income tax returns are currently under examination by taxing authorities.

Stock-Based Compensation

The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers and directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees using a fair value approach under Accounting Standards Codification (“ASC”) subtopic 505-50, inclusive of the modifications made by ASU 2018-07. The Company values equity instruments and stock options granted using the Black-Scholes option pricing model.

Basic and Diluted Net Loss per Share of Common Stock

The Company uses the two-class method to compute net loss per common share because the Company has issued securities, other than common stock, that contractually entitle the holders to participate in dividends and earnings of the Company. The two-class method requires earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive distributed and undistributed earnings. Holders of each series of the Company’s convertible preferred stock and select warrants are entitled to participate in distributions, when and if declared by the board of directors, that are made to common stockholders and, as a result, are considered participating securities.

Segment and Geographic Information

Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. All assets of the Company were held in the United States as of December 31, 2019 and 2018.

Application of New or Revised Accounting Standards—Adopted

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use assets on the balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leases. The Company leases office space and laboratory facilities under non-cancelable operating leases. In addition, the Company leases various laboratory equipment, furniture and office equipment and leasehold improvements that are accounted for as capital leases. The Company adopted the new standard effective January 1, 2019 on a modified retrospective basis and did not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance, which allowed the Company to carryforward its historical lease classification and its assessment on whether a contract is or contains a lease for any leases that existed prior to adoption of the new standard. The Company also elected to combine lease and non-lease components and to keep leases with an initial term of 12 months or less off the balance sheet and recognize the associated lease payments in the statements of operations on a straight-line basis over the lease term. The Company did not elect the hindsight practical expedient, which would have allowed the Company to use hindsight in determining the lease term and in assessing any impairment of right-of-use assets during the lookback period. The adoption of ASU 2016-02 resulted in the recognition of total right-of-use assets and total lease liabilities of approximately $2.6 million on the balance sheets as of January 1, 2019.

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815)—I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”), which addresses the complexity of accounting for certain financial instruments with down round features and addresses the difficulty of navigating Topic 480 because of the existence of extensive pending content in the ASC as a result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. This update applies to all entities that issue financial instruments that include down round features and entities that present earnings per share in accordance with Topic 260. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The adoption of ASU 2017-11 did not have a material impact on the Company’s financial statements and disclosures.

In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 820)—Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), which simplifies several aspects of the accounting for nonemployee share-based payment transactions resulting from expanding the scope of Topic 718, Compensation—Stock Compensation, to include share-based payment transactions for acquiring goods and services from nonemployees. This update applies to all entities that enter into share-based payment transactions for acquiring goods and services from nonemployees. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The amendments in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The adoption of ASU 2018-07 did not have a material impact on the Company’s financial statements and disclosures.

Application of New or Revised Accounting Standards—Not Yet Adopted

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the FASB Concepts Statement, Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, which the FASB finalized on August 28, 2018, including the consideration of costs and benefits. This update applies to all entities that are required, under existing GAAP, to make disclosures about recurring or nonrecurring fair value measurements. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. An entity is permitted to early adopt any removed or modified disclosures and delay adoption of the additional disclosures until their effective date. The Company does not expect the adoption of ASU 2018-13 to have a material impact on the Company’s financial statements and disclosures.

Accounts and Other Receivables

12 Months Ended

Dec. 31, 2019

Loans, Notes, Trade and Other Receivables Disclosure [Text Block]

C.	Accounts and Other Receivables

Accounts and other receivables consist of the following (in thousands):


	December 31,
	2019		2018
Accounts receivable	$	1,681	$	—
Other receivables		184		140

Total accounts and other receivables	$	1,865	$	140

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2019

Other Current Assets [Text Block]

D.	Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):


	December 31,
	2019		2018
Prepaid insurance	$	250	$	224
Deferred direct contract acquisition costs		805		—
Prepaid offering costs		266		—
Other prepaid expenses and current assets		231		1,688

Total prepaid expenses and other current assets	$	1,552	$	1,912

Property and Equipment

12 Months Ended

Dec. 31, 2019

Property, Plant and Equipment Disclosure [Text Block]

E.	Property and Equipment

Property and equipment consists of the following (in thousands):


	December 31,
	2019			2018
Laboratory equipment	$	638		$	1,035
Furniture and office equipment		119			655
Computers and hardware		303			299
Leasehold improvements		958			1,017
Finance lease right-of-use assets		1,013			—

Total property and equipment		3,031			3,006
Less: accumulated depreciation and amortization		(1,560	)		(1,253	)

Property and equipment, net	$	1,471		$	1,753

The estimated useful lives of property and equipment are as follows:


Asset Category		Useful Life (in years)
Laboratory equipment		10
Furniture and office equipment		5 - 10
Computers and hardware		3 - 7
Leasehold improvements		9

Depreciation and amortization expense, including amounts pertaining to assets held under finance leases, was approximately $304,000 and $324,000 for the years ended December 31, 2019 and 2018, respectively.

Accounts Payable and Accrued Expenses

12 Months Ended

Dec. 31, 2019

Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block]

F.	Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consist of the following (in thousands):


	December 31,
	2019		2018
Accrued interest	$	359	$	1,921
Accrued banking fees		700		700
Accrued severance		—		193
Accrued payroll		1		731
Accrued professional fees		2,364		230
Accounts payable		1,140		3,715
Other accrued expenses		347		852

Total accounts payable and accrued expenses	$	4,911	$	8,342

Debt Obligations

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Debt Disclosure [Text Block]

C.	Debt Obligations

As of September 30, 2020 and December 31, 2019, the Company had convertible notes outstanding, in the aggregate principal amounts, as follows (in thousands):


	September 30, 2020			December 31, 2019
Deerfield Convertible Note	$	7,340		$	6,981
2021 Notes		—			3,000
December 2019 Notes		56,615			70,218
January 2020 Note		3,133			—

Total outstanding principal on debt obligations		67,088			80,199
Less: debt issuance costs and discounts		(1,168	)		(2,856	)

Convertible notes, net	$	65,920		$	77,343

Deerfield Facility Agreement

In June 2014, the Company entered into a $60 million multi-tranche credit facility (the “Deerfield Facility Agreement”) with Deerfield Private Design Fund III, LP (“Deerfield”). At the time the Company entered into the Deerfield Facility Agreement, the Company borrowed the first tranche, which consisted of a term loan of $15 million (the “Term Note”) and a senior secured loan of $10 million (the “Deerfield Convertible Note”). Deerfield is no longer obligated to provide the Company any additional disbursements under the Deerfield Facility Agreement. Deerfield may convert any portion of the outstanding principal and any accrued but unpaid interest on the Deerfield Convertible Note into shares of the Company’s common stock at an initial conversion price of $5.85 per share (the “Deerfield Note Put Option”). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price became $93.60.

The Deerfield Convertible Note originally bore interest at 9.75% per annum, but was subsequently reduced to 6.75%. Interest accrued on the outstanding balance under the Deerfield Convertible Note was due quarterly in arrears. The Company originally had to repay one-third of the outstanding principal amount of the Deerfield Convertible Note on the fourth and fifth anniversaries of the Deerfield Facility Agreement (June 2018 and June 2019). In June 2018, Deerfield agreed to convert the $3,333,333 of the principal amount then due, plus $168,288 of accrued interest, into 37,410 shares of our common stock (as discussed below in the section entitled “Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note”). In September 2019, the Company entered into an amendment with Deerfield in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from 9.75% to 6.75%, (ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments due pursuant to the Deerfield Facility Agreement until June 1, 2020 (as discussed below in the section entitled “2021 Note Exchange Effected in September 2019”). In December 2019, the Company entered into another amendment with Deerfield in order to (i) defer the Loan payments due pursuant to the Deerfield Facility Agreement until March 31, 2021 and (ii) allow for the entries of additional debt and debt holders under the Deerfield Facility Agreement (as discussed below in the section entitled “2021 Note Exchange Effected in December 2019”). The Company is also obligated to repay principal of the Deerfield Convertible Note in the amount of $6,980,824 plus any capitalized interest to date on March 31, 2021. Prepayment of the outstanding balance is not allowed without written consent of Deerfield.

Pursuant to the Deerfield Facility Agreement, the Company issued to Deerfield 1,923,077 shares of Series D redeemable convertible preferred stock (“Series D Preferred”) as consideration for the loans provided to the Company thereunder. Upon completion of the initial public offering, these shares of Series D Preferred automatically reclassified into 256,410 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the reclassified shares became 16,025 shares.

The Company also issued to Deerfield a warrant to purchase 14,423,076 shares of Series D Preferred at an initial exercise price of $0.78 per share, which is exercisable until June 2, 2024 (the “Deerfield Warrant”). Upon completion of the Company’s initial public offering, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 and the shares issuable upon conversion of the warrant became 120,192 shares of common stock. This warrant qualifies as a participating security under ASC Topic 260, Earnings per Share, and is treated as such in the net loss per share calculation (Note I). If a Major Transaction occurs (as defined in the Deerfield Facility Agreement) Deerfield may require the Company to redeem the Deerfield Warrant for a cash amount equal to the Black-Scholes value of the portion of the Deerfield Warrant to be redeemed (the “Warrant Put Option”).

The Company recorded the fair value of the shares of Series D Preferred to debt issuance costs on the date of issuance. The Company also recorded the fair value of the Deerfield Warrant and the embedded Warrant Put Option to debt discount on the date of issuance. The debt issuance costs and debt discount are amortized over the term of the related debt and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the statements of operations.

Pursuant to the Deerfield Facility Agreement, the Company may not enter into specified transactions, including a debt financing in the aggregate value of $750,000 or more, other than permitted indebtedness under the Deerfield Facility Agreement, a merger, an asset sale or any other change of control transaction or any joint venture, partnership or other profit sharing arrangement, without the prior approval of the Required Lenders (as defined in the Deerfield Facility Agreement). Additionally, if the Company were to enter into a major transaction, including a merger, consolidation, sale of substantially all of its assets or other change of control transaction, Deerfield would have the ability to demand that prior to consummation of such transaction the Company repay all outstanding principal and accrued interest of any notes issued under the Deerfield Facility Agreement. Under each warrant issued pursuant to the Deerfield Facility Agreement, Deerfield has the right to demand that the Company redeem the warrant for a cash amount equal to the Black-Scholes value of a portion of the warrant upon the occurrence of specified events, including a merger, an asset sale or any other change of control transaction.

The Deerfield Facility Agreement also includes high yield discount obligation protections that went into effect in June 2019. Going forward, if at any interest payment date our outstanding indebtedness under the Deerfield Facility Agreement would qualify as an “applicable high yield discount obligation” under the Internal Revenue Code of 1986 (the” Code”) then the Company is obligated to prepay in cash on each such date the amount necessary to avoid such classification.

Issuance of 5.50% Senior Convertible Notes and Third Amendment to Senior Secured Convertible Note and Warrant

In February 2016, the Company issued $86.3 million aggregate principal amount of its 5.50% Senior Convertible Notes due 2021 (the “2021 Notes”) to Cowen and RBC Capital Markets, LLC, as representatives of the several initial purchasers (the “Initial Purchasers”), who subsequently resold the 2021 Notes to qualified institutional buyers (the “Note Offering”) in reliance on the exemption from registration provided by Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).

The 2021 Notes were issued pursuant to an indenture, dated as of February 9, 2016 (the “Indenture”), between the Company and U.S. Bank National Association, as trustee (the “Trustee”). Interest on the 2021 Notes was payable semi-annually in cash in arrears on February 1 and August 1 of each year, beginning on August 1, 2016, at a rate of 5.50% per year. The 2021 Notes had an original maturity of February 1, 2021 unless earlier converted or repurchased.

The net proceeds from the Note Offering were approximately $82.8 million, after deducting the Initial Purchasers’ discount and estimated offering expenses. Concurrent with the Note Offering, the Company used approximately $18.6 million of the net proceeds from the Note Offering to repay in full the Term Note, plus all accrued but unpaid interest, a make-whole interest payment and a prepayment premium on the Term Note.

The 2021 Notes were not redeemable prior to the maturity date, and no sinking fund was provided for the 2021 Notes. The 2021 Notes were convertible at an initial conversion rate of 58.4454 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, subject to adjustment under the Indenture, which is equal to an initial conversion price of approximately $17.11 per share of common stock. Effected for the 1-for-16 reverse stock split in December 2020 the conversion rate of the 2021 Notes would be approximately 3.6528 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, which is equal to a conversion price of approximately $273.76 per share.

The Indenture included customary terms and covenants, including certain events of default after which the 2021 Notes may be due and payable immediately.

As described in more detail below, in multiple exchanges occurring in October 2018, December 2019 and January 2020, all outstanding 2021 Notes were exchanged by the holders thereof for either shares of our common stock or senior secured convertible promissory notes issued under the terms of the Deerfield Facility Agreement.

Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note

In June 2018, the Company entered into the Facility Agreement Waiver and Fifth Amendment (the “Fifth Amendment”) to the Deerfield Convertible Note with Deerfield. The Fifth Amendment, among other things, provided that (i) $3,333,333 of the principal amount, plus $168,288 of accrued interest, of the Deerfield Convertible Note issued pursuant to the terms of the Deerfield Facility Agreement was converted into 37,410 shares of the Company’s common stock, with such principal conversion amount being applied against and in full satisfaction of the amortization payment due June 2, 2018; (ii) Deerfield waived specified rights under the Deerfield Facility Agreement with regards to such principal and interest amount; and (iii) amended specified provisions of the Deerfield Convertible Note as they relate to the delivery of shares of the Company’s common stock in connection with any conversion of the Deerfield Convertible Note.

2021 Note Exchange Effected in October 2018

In October 2018, the Company entered into an exchange agreement (the “October 2018 Exchange Agreement”) with Deerfield and Deerfield Special Situations Fund, L.P. (the “Deerfield Lenders”). Under the October 2018 Exchange Agreement, the Deerfield Lenders exchanged an aggregate of $9,577,000 principal amount of the 2021 Notes for an aggregate of 9,577 shares of Series A Convertible Preferred Stock, par value $0.0001 (“Series A Preferred Stock”).

As a condition to closing of the October 2018 Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series A Preferred Stock.

Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the then outstanding Series A Preferred Stock (without giving effect to the limitation on conversion described below). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 per share and shares of common stock issuable upon conversion of the Series A Preferred Stock would be 199,519 shares of common stock. As of September 30, 2020, all 9,577 shares of Series A Preferred Stock issued under the October 2018 Exchange Agreement have been converted into an aggregate 199,519 shares of the Company’s common stock.

2021 Note Exchange Effected in September 2019

In September 2019, the Company entered into an Exchange Agreement and Amendment to Facility Agreement (the “September 2019 Exchange Agreement”) with the Deerfield Lenders. Under the September 2019 Exchange Agreement, the Company issued an aggregate of 93,742 shares of the Company’s common stock and an aggregate of 1,576 shares of the Company’s Series B-1 Convertible Preferred Stock, par value $0.0001 per share (“Series B-1 Preferred Stock”) (such shares of common stock and Series B-1 Preferred Stock, the “Initial Exchange Shares”), in exchange for the cancellation of an aggregate of $3,000,000 principal amount of the Company’s 2021 Notes. The September 2019 Exchange Agreement provided the Deerfield Lenders the option to exchange up to an additional aggregate of $27,000,000 principal amount of the 2021 Notes (the “Optional Exchange Principal Amount”) for shares of common stock or shares of the Company’s Series B-2 Convertible Preferred Stock, par value $0.0001 per share (the “Series B-2 Preferred Stock” and, together with the Series B-1 Preferred Stock, the “Series B Preferred Stock”), subject to the terms and conditions set forth in the September 2019 Exchange Agreement, including limits as to the principal amount that can be exchanged prior to specified dates therein. If the Deerfield Lenders choose to exchange any portion of the Optional Exchange Principal Amount for shares of Series B-2 Preferred Stock, such exchange will be effected at an exchange price of $1,000 per share. If the Deerfield Lenders choose to exchange any portion of the Optional Exchange Principal Amount for shares of common stock, such exchange will be effected at an exchange price equal to the greater of (i) $0.9494, or (ii) the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange. After giving effect to the Reverse Stock Split effected in December 2020, the exchange price of the Optional Exchange Principal Amount would be $15.1904 or the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange.

As a condition to closing of the September 2019 Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible Preferred Stock (the “Series B-1 Certificate of Designation”) and a Certificate of Designation of Preferences, Rights and Limitations of Series B-2 Convertible Preferred Stock (the “Series B-2 Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series B-1 Preferred Stock and the Series B-2 Preferred Stock, respectively.

Each share of Series B-1 Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a per share price equal to $0.9494 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the September 2019 Exchange Agreement, there were an aggregate of 1,659,996 shares of common stock issuable upon conversion of the then outstanding Series B-1 Preferred Stock (without giving effect to the limitation on conversion described below). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series B-1 Preferred Stock would be $15.1904 and the shares of common stock issuable upon conversion of the Series B-1 Preferred Stock would be 103,749 shares of common stock. Each share of Series B-2 Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a per share price equal to the greater of (i) $0.9494 (subject to adjustment to reflect stock splits and similar events), or (ii) the average of the volume-weighted average prices of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange. Immediately following the exchange under the September 2019 Exchange Agreement there was an aggregate of 28,439,015 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount (in each case without giving effect to the limitation on conversion described below). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series B-2 Preferred Stock would be $15.1904 or the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange and the shares of stock issuable in exchange of the Optional Exchange Principal Amount or upon conversion of Series B-2 Preferred stock would be 1,777,437 shares of common stock.

The Series B Preferred Stock is convertible at any time at the option of the Deerfield Lenders; provided that the Deerfield Lenders are prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holders (together with certain affiliates and “group” members of such holders) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. The Series B Preferred Stock is not redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Deerfield Lenders will receive an amount equal to $0.0001 per share, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock and with the holders of any shares of any other class or series of capital stock of the Company entitled to share in such remaining assets of the Company (including the Series A Preferred Stock on an as-converted basis). With respect to rights upon liquidation, the Series B Preferred Stock ranks senior to the common stock, on parity with the Series A Preferred Stock, if any is outstanding, and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that materially and adversely affect the holders of Series B Preferred Stock), the Series B Preferred Stock does not have voting rights. The Series B Preferred Stock is not subject to any price-based anti-dilution protections and does not provide for any accruing dividends, but provides that holders of Series B Preferred Stock will participate in any dividends on the common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Series B-1 Certificate of Designation and the Series B-2 Certificate of Designation also provide for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-1 Preferred Stock or Series B-2 Preferred Stock, respectively, into common stock in accordance with the applicable certificate of designation.

As of September 30, 2020, all 1,576 shares of Series B-1 Preferred Stock issued under the September 2019 Exchange Agreement have been converted into an aggregate of 103,749 shares of common stock, and there were no shares of Series B-2 Preferred Stock outstanding.

The September 2019 Exchange Agreement also amended the Deerfield Facility Agreement, in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from 9.75% to 6.75%, (ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments pursuant to the Deerfield Facility Agreement until June 1, 2020. The September 2019 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Holders. The September 2019 Exchange Agreement also requires the Company to reimburse the Holders for up to $150,000 of expenses relating to the transactions contemplated by the September 2019 Exchange Agreement.

The Company determined the changes to the Deerfield Facility Agreement met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties and Deerfield granted a concession. The amendments to the terms of the Deerfield Facility Agreement resulted in no gain on restructuring because the total cash outflows required under the amended Deerfield Facility Agreement exceeded the carrying value of the original Deerfield Facility Agreement immediately prior to amendment. Prospectively, the Deerfield Facility Agreement, and the associated Deerfield Convertible Note will continue to be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

The changes to the 2021 Notes, under the September 2019 Exchange Agreement, were accounted for as a debt modification with the $2.3 million change in fair value of the embedded conversion feature, associated with the Optional Exchange Principal Amount, recorded as an increase to additional paid in capital and as a debt discount to be amortized to interest expense under the effective interest method over the remaining term of the 2021 Notes.

2021 Note Exchange Effected in December 2019

In December 2019, the Company entered into the December 2019 Exchange Agreement and Amendment to Facility Agreement, Senior Secured Convertible Notes and Warrants (the “December 2019 Exchange Agreement”) with the Deerfield Lenders and Delaware Street Capital Master Fund, L.P. (“DSC” and, collectively with the Deerfield Lenders, the “December 2019 Holders”). Under the December 2019 Exchange Agreement, the Company issued senior secured convertible promissory notes under the Deerfield Facility Agreement in the aggregate principal amount of $71,418,011 (the “December 2019 Notes”), in exchange for the cancellation of an aggregate of $71,418,011 principal amount and accrued interest of the Company’s 2021 Notes. Upon entering into the December 2019 Exchange Agreement, the Company agreed to pay the December 2019 Holders, in the aggregate, an interest payment of $745,011 which represents 50% of the accrued interest, as of December 18, 2019, on the 2021 Notes owned by the December 2019 Holders. The remainder of such interest was included in the principal amount of the December 2019 Notes.

The December 2019 Notes bear interest at 6.75% per annum. The December 2019 Notes are convertible into shares of the Company’s common stock at an initial conversion price of $17.11 per share (which represents the conversion price of the 2021 Notes), subject to adjustment in accordance with the terms of the December 2019 Notes. As of the date of issuance, the December 2019 Notes were convertible, by their terms, into an aggregate of 4,174,051 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the December 2019 Notes would be $273.76 per share and the shares of the Company’s common stock issuable upon conversion of the December 2019 Notes would be 260,876 shares of common stock. The Company subsequently amended the December 2019 Notes to provide that such notes shall be convertible into shares of the Company’s common stock at a conversion price of $93.60 per share (which represents the conversion price of the Deerfield Convertible Note). The conversion price of the December 2019 Notes will be adjusted downward if the Company issues or sells any shares of common stock, convertible securities, warrants or options at a sale or exercise price per share less than the greater of the December 2019 Notes’ conversion price or the closing sale price of the Company’s common stock on the last trading date immediately prior to such issuance, or, in the case of a firm commitment underwritten offering, on the date of execution of the underwriting agreement between the Company and the underwriters for such offering. However, if the Company effects an “at the market offering” as defined in Rule 415 of the Securities Act, of its common stock, the conversion price of the December 2019 Notes will be adjusted downward pursuant to this anti-dilution adjustment only if such sales are made at a price less than $93.60 per share, provided that this anti-dilution adjustment will not apply to any sales made under (x) the Current Purchase Agreement, (y) the ATM Agreement, or (z) the September 2019 Exchange Agreement (as amended). Notwithstanding anything in the contrary in the December 2019 Notes, the anti-dilution adjustment of such notes shall not result in the conversion price of the December 2019 Notes being less than $9.328 per share. The December 2019 Notes are convertible at any time at the option of the holders thereof, provided that a holder of a December 2019 Note is prohibited from converting such note into shares of the Company’s common stock if, as a result of such conversion, such holder (together with certain affiliates and “group” members) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. However, the December 2019 Note issued to DSC, due to the fact DSC was a beneficial owner of more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding, has a beneficial ownership cap equal to 19.985% of the total number of shares of the Company’s common stock then issued and outstanding. Pursuant to the December 2019 Notes, the December 2019 Holders have the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon, in connection with a Major Transaction (as defined in the December 2019 Notes), which shall include, among others, any acquisition or other change of control of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time after March 31, 2021, shares of the Company’s common stock are not listed on an Eligible Market (as defined in the December 2019 Notes). The December 2019 Notes are subject to specified events of default, the occurrence of which would entitle the December 2019 Holders to immediately demand repayment of all outstanding principal and accrued interest on the December 2019 Notes. Such events of default include, among others, failure to make any payment under the December 2019 Notes when due, failure to observe or perform any covenant under the Deerfield Facility Agreement (as defined below) or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgement levied against the Company and a material default by the Company under the Deerfield Warrant, the December 2019 Notes or the Deerfield Convertible Note.

The December 2019 Exchange Agreement amends the Deerfield Facility Agreement in order to, among other things, (i) provide for the Deerfield Facility Agreement to govern the December 2019 Notes received by the December 2019 Holders pursuant to the December 2019 Exchange Agreement, (ii) extend the maturity of the Deerfield Convertible Note from February 14, 2020 and June 1, 2020, as applicable, to March 31, 2021, (iii) defer interest payments on the Deerfield Convertible Note until March 31, 2021 (which such interest shall accrue as “payment-in-kind” interest), (iv) designate DSC as a Lender under (and as defined in the Deerfield Facility Agreement), (v) name Deerfield as the “Collateral Agent” for all Lenders and (vi) modify the terms and conditions under which the Company may issue additional pari passu and subordinated indebtedness under the Deerfield Facility Agreement (subject to certain conditions specified in the Deerfield Facility Agreement).

The December 2019 Exchange Agreement also amends the Deerfield Warrant to conform the definitions of “Eligible Market” and “Major Transaction” in the Warrant with the definitions of such terms in the December 2019 Notes.

The December 2019 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the December 2019 Holders, including a covenant of the Company to, upon request, use commercially reasonable efforts to use its technology to discover a product based upon a compound that may be identified by the Deerfield Lenders in a manner that is reasonably acceptable to the Deerfield Lenders, or one of their affiliates, with the terms of such discovery plan, including the Company’s compensation thereunder, to be mutually agreed to by the parties.

In connection with entering into the December 2019 Exchange Agreement, on December 18, 2019, the Company amended and restated that certain Guaranty and Security Agreement, dated June 2, 2014, by and between the Company and the other parties thereto (the “GSA”) to, among other things, (i) provide that all of the notes will be secured by the liens securing the indebtedness under the Deerfield Facility Agreement, and (ii) name Deerfield as the “Collateral Agent” under the GSA.

In connection with entering into the December 2019 Exchange Agreement, the Company also entered into an amendment (the “September 2019 Exchange Agreement Amendment”) to the September 2019 Exchange Agreement to, among other things, (i) amend and restate Annex I of the September 2019 Exchange Agreement to allow the Deerfield Lenders to effect optional exchanges of the December 2019 Notes and the Deerfield Convertible Note under the terms of the September 2019 Exchange Agreement; (ii) amend the common stock exchange price under the September 2019 Exchange Agreement to be a per share price equal to the greater of (x) $0.60, subject to adjustment to reflect stock splits and similar events, or (y) the average of the volume-weighted average prices of the Company’s common stock on each of the 15 trading days immediately preceding such exchange, (iii) provide that no more than 28,439,015 of shares of the Company’s common stock shall be issued pursuant to optional exchanges under the September 2019 Exchange Agreement (whether by common stock exchange or upon conversion of Series B-2 Shares (as defined in the September 2019 Exchange Agreement Amendment)), subject to adjustment to reflect stock splits and similar events and (iv) eliminate limitations regarding the timing and aggregate amount of principal which may be exchanged under the September 2019 Exchange Agreement. These changes in the September 2019 Exchange Agreement Amendment significantly modified the Optional Exchange Principal Amount, as such after giving effect to the September Exchange Agreement Amendment the Optional Exchange Principal Amount ceases to exist the new optional exchanges are referred to as the Deerfield Optional Conversion Feature. Effected for the 1-for-16 reverse stock split in December 2020 the exchange price of the Deerfield Optional Conversion Feature would be $9.60 per share or the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange and the shares of the Company’s common stock issued pursuant to the optional exchanges would be 1,777,437 shares of common stock.

In connection with entering into the September 2019 Amendment, the Company filed an amendment to the Series B-2 Certificate of Designation (the “Series B-2 Certificate of Designation Amendment”) with the Secretary of State of the State Delaware. The Series B-2 Certificate of Designation Amendment provides that each share of the Company’s Series B-2 preferred stock is convertible into shares of the Company’s common stock at a per share price equal to the common stock exchange price under the September 2019 Exchange Agreement, which equals the greater of (i) $9.60 (subject to adjustment to reflect stock splits and similar events), or (ii) the average of the volume-weighted average prices of the Company’s common stock on each of the 15 trading days immediately preceding such exchange.

As of September 30, 2020, the Deerfield Lenders have converted $17.1 million of principal under the December 2019 Notes into all 1,777,437 shares of common stock available under the Deerfield Optional Conversion Feature.

The Company determined the changes to the Deerfield Convertible Note met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties and Deerfield granted a concession. The amendments to the terms of the Deerfield Convertible Note resulted in no gain on restructuring because the total cash outflows required under the amended Deerfield Convertible Note exceeded the carrying value of the original Deerfield Convertible Note immediately prior to amendment. Prospectively, the Deerfield Convertible Note will continue to be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

The changes to the 2021 Notes, under the December 2019 Exchange Agreement, referred to after as the December 2019 Notes, were accounted for as a debt modification, prospectively, the December 2019 Notes will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

2021 Note Exchange Effected in January 2020

In January 2020, the Company entered into the January 2020 Exchange Agreement (the “January 2020 Exchange Agreement”) with M. Kingdon Offshore Master Fund, LP (“Kingdon”). Under the January 2020 Exchange Agreement, the Company issued a senior secured convertible note in the aggregate principal amount of $3,037,354 (the “January 2020 Note”) in exchange for the cancellation of an aggregate of $3,037,354 principal amount and accrued interest of the 2021 Note then owned by Kingdon. Upon entering into the January 2020 Exchange Agreement, the Company agreed to pay Kingdon an interest payment of $37,354, which represents 50% of the accrued and unpaid interest, as of January 13, 2020, on Kingdon’s 2021 Note. The remainder of such interest was included in the principal amount of the January 2020 Note.

The January 2020 Note was issued with substantially the same terms and conditions as the December 2019 Notes (as amended by the amendment described in more detail below).

In connection with entering into the January 2020 Exchange Agreement, the Company entered into an Amendment to Facility Agreement and December 2019 Notes and Consent (the “December 2019 Note Amendment”) with the December 2019 Holders that, among other things, (i) amended the December 2019 Notes to (a) reduce the Conversion Price (as defined in the December 2019 Notes) from $17.11 to $5.85 per share and (b) increased the Floor Price (as defined in the December 2019 Notes) from $0.38 to $0.583 per share, and (ii) amended the Deerfield Facility Agreement to (x) provide for Kingdon to join the Deerfield Facility Agreement as a Lender (as defined in the Deerfield Facility Agreement) and (y) provide that the 2020 Note and shall constitute a “Senior Secured Convertible Note” (as defined in the Deerfield Facility Agreement) for purposes of the Deerfield Facility Agreement and other Transaction Documents (as defined in the Deerfield Facility Agreement). Effected for the 1-for-16 reverse stock split in December 2020 the Conversion Price became $93.60 per share and the Floor Price became $9.328 per share.

The changes to the 2021 Note, under the January 2020 Exchange Agreement, referred to after as the January 2020 Note, were accounted for as a debt modification, prospectively, the January 2020 Note will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

PPP Loan

On April 23, 2020 the Company received proceeds of $0.8 million from the PPP Loan under the PPP of the recently enacted CARES Act, a portion of which may be forgiven, which the Company used to retain current employees, maintain payroll and make lease and utility payments. The PPP Loan matures on April 23, 2022 and bears annual interest at a rate of 1.0%. Payments of principal and interest on the PPP Loan were originally deferred for the first six months of the PPP Loan term. Thereafter, the Company would have been required to pay the lender equal monthly payments of principal and interest.

The CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. Under the PPP, the Company may apply for and be granted forgiveness for all or part of the PPP Loan. The amount of loan proceeds eligible for forgiveness was originally based on a formula that takes into account a number of factors, including the amount of loan proceeds used by the Company during the eight-week period after the loan origination for certain purposes, including payroll costs, interest on certain mortgage obligations, rent payments on certain leases, and certain qualified utility payments, provided that at least 75% of the loan amount was used for eligible payroll costs. Subject to the other requirements and limitations on loan forgiveness, only loan proceeds spent on payroll and other eligible costs during the covered eight-week period would have qualified for forgiveness.

On June 5, 2020, President Trump signed into law the PPP Flexibility Act of 2020 (the “Flexibility Act”), which among other things provided the following important changes to the PPP:

•

Extended the covered period for loan forgiveness from eight weeks after the date of loan disbursement to 24 weeks after the date of loan disbursement, providing substantially greater flexibility for borrowers to qualify for loan forgiveness. Borrowers who had already received PPP loans retained the option to use an eight-week covered period.

•

Lowered the requirements that 75 percent of a borrower’s loan proceeds must be used for payroll costs and that 75 percent of the loan forgiveness amount must have been spent on payroll costs during the 24-week loan forgiveness covered period to 60 percent for each of these requirements. If a borrower uses less than 60 percent of the loan amount for payroll costs during the forgiveness covered period, the borrower will continue to be eligible for partial loan forgiveness, subject to at least 60 percent of the loan forgiveness amount having been used for payroll costs.

•

Provided a safe harbor from reductions in loan forgiveness based on reductions in full-time equivalent employees for borrowers that are unable to return to the same level of business activity the business was operating at before February 15, 2020, due to compliance with requirements or guidance issued between March 1, 2020 and December 31, 2020 by the Secretary of Health and Human Services, the Director of the Centers for Disease Control and Prevention, or the Occupational Safety and Health Administration, related to worker or customer safety requirements related to COVID–19.

•

Provided a safe harbor from reductions in loan forgiveness based on reductions in full-time equivalent employees, to provide protections for borrowers that are both unable to rehire individuals who were employees of the borrower on February 15, 2020, and unable to hire similarly qualified employees for unfilled positions by December 31, 2020.

•

Increased to five years the maturity of PPP loans that are approved by the U.S. Small Business Administration (the “SBA”) (based on the date SBA assigns a loan number) on or after June 5, 2020.

•

Extended the deferral period for borrower payments of principal, interest, and fees on PPP loans to the date that SBA remits the borrower’s loan forgiveness amount to the lender (or, if the borrower does not apply for loan forgiveness, 10 months after the end of the borrower’s loan forgiveness covered period).

Based on the changes provided by the Flexibility Act the Company plans to take advantage of (i) the extended covered period for loan forgiveness from eight weeks to 24 weeks, (ii) the lowered requirement that a certain percentage of loan proceeds must be used for payroll costs from 75 percent to 60 percent, (iii) the extended deferral period for payments of principal, interest and fees from six months after loan disbursement to 10 months after the SBA remits the borrower’s loan forgiveness amount to the lender and (iv) take advantage of an safe harbor provisions as applicable. The Company will be required to repay any portion of the outstanding principal that is not forgiven, along with accrued interest, in accordance with the amortization schedule described above. Based on the changes provided by the Flexibility Act the Company expects that substantially all of the PPP loan will be forgiven, however, the Company cannot provide any assurance that the Company will be eligible for loan forgiveness, that the Company will ultimately apply for forgiveness, or that any amount of the PPP Loan will ultimately be forgiven by the SBA.

G.	Debt Obligations

As of December 31, 2019 and 2018, the Company had convertible notes outstanding, in the aggregate principal amounts, as follows (in thousands):


	December 31,
	2019			2018
Deerfield Convertible Note	$	6,981		$	6,667
2021 Notes		3,000			76,673
December 2019 Notes		70,218			—

Total outstanding principal on debt obligations		80,199			83,340

Less: debt issuance costs and discounts		(2,856	)		(1,902	)

Convertible notes, net	$	77,343		$	81,438

Deerfield Facility Agreement

The Company also issued to Deerfield a warrant to purchase 14,423,076 shares of Series D Preferred at an initial exercise price of $0.78 per share, which is exercisable until June 2, 2024 (the “Deerfield Warrant”). Upon completion of the Company’s initial public offering, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. Subsequent to the 1-for-16 reverse stock split in December 2020 the conversion price of the Deerfield Warrant became $93.60 per share and the warrant became exercisable into 120,192 shares of the Company’s common stock. This warrant qualifies as a participating security under ASC Topic 260, Earnings per Share, and is treated as such in the net loss per share calculation (Note J). If a Major Transaction occurs (as defined in the Deerfield Facility Agreement) Deerfield may require the Company to redeem the Deerfield Warrant for a cash amount equal to the Black-Scholes value of the portion of the Deerfield Warrant to be redeemed (the “Warrant Put Option”).

Issuance of 5.50% Senior Convertible Notes and Third Amendment to Senior Secured Convertible Note and Warrant

The 2021 Notes were not redeemable prior to the maturity date, and no sinking fund was provided for the 2021 Notes. The 2021 Notes were convertible at an initial conversion rate of 58.4454 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, subject to adjustment under the Indenture, which is equal to an initial conversion price of approximately $17.11 per share of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion rate of the 2021 Notes would be approximately 3.6528 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, which is equal to a conversion price of approximately $273.76 per share of common stock.

If the Company underwent a “fundamental change” (as defined in the Indenture), holders could have required that the Company repurchase for cash all or any portion of their 2021 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2021 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. As December 31, 2019, the Company is bifurcating the fundamental change and make-whole interest payment provisions as embedded derivatives and marking them to fair value each reporting period (Note M).

The Indenture included customary terms and covenants, including certain events of default after which the 2021 Notes may be due and payable immediately.

Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note

2021 Note Exchange Effected in October 2018

Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the then outstanding Series A Preferred Stock (without giving effect to the limitation on conversion described below). As of December 31, 2019, all 9,577 shares of Series A Preferred Stock issued under the October 2018 Exchange Agreement have been converted into an aggregate 199,519 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 per share and the aggregate shares of common stock issuance upon conversion of the Series A Preferred Stock would be 199,519 shares of common stock.

2021 Note Exchange Effected in September 2019

In September 2019, the Company entered into an Exchange Agreement and Amendment to Facility Agreement (the “September 2019 Exchange Agreement”) with the Deerfield Lenders. Under the September 2019 Exchange Agreement, the Company issued an aggregate of 93,742 shares of the Company’s common stock and an aggregate of 1,576 shares of the Company’s Series B-1 Convertible Preferred Stock, par value $0.0001 per share (“Series B-1 Preferred Stock”) (such shares of common stock and Series B-1 Preferred Stock, the “Initial Exchange Shares”), in exchange for the cancellation of an aggregate of $3,000,000 principal amount of the Company’s 2021 Notes. The September 2019 Exchange Agreement provided the Deerfield Lenders the option to exchange up to an additional aggregate of $27,000,000 principal amount of the 2021 Notes (the “Optional Exchange Principal Amount”) for shares of common stock or shares of the Company’s Series B-2 Convertible Preferred Stock, par value $0.0001 per share (the “Series B-2 Preferred Stock” and, together with the Series B-1 Preferred Stock, the “Series B Preferred Stock”), subject to the terms and conditions set forth in the September 2019 Exchange Agreement, including limits as to the principal amount that can be exchanged prior to specified dates therein. If the Deerfield Lenders choose to exchange any portion of the Optional Exchange Principal Amount for shares of Series B-2 Preferred Stock, such exchange will be effected at an exchange price of $1,000 per share. If the Deerfield Lenders choose to exchange any portion of the Optional Exchange Principal Amount for shares of common stock, such exchange will be effected at an exchange price equal to the greater of (i) $0.9494, or (ii) the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange. After giving effect to the Reverse Stock Split effected in December 2020, the exchange price of the Optional Exchange Principal Amount would be $15.1904, or the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange.

Each share of Series B-1 Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a per share price equal to $0.9494 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the September 2019 Exchange Agreement, there were an aggregate of 1,659,996 shares of common stock issuable upon conversion of the then outstanding Series B-1 Preferred Stock (without giving effect to the limitation on conversion described below). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series B-1 Preferred Stock would be $15.1904 per share and the common stock issuable upon conversion of the then outstanding Series B-1 Preferred Stock would be an aggregate of 103,749 shares of common stock. Each share of Series B-2 Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a per share price equal to the greater of (i) $0.9494 (subject to adjustment to reflect stock splits and similar events), or (ii) the average of the volume-weighted average prices of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange. Immediately following the exchange under the September 2019 Exchange Agreement there was an aggregate of 28,439,015 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount (in each case without giving effect to the limitation on conversion described below). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series B-2 Preferred Stock would be $15.1904 per share or the average of the volume-weighted average prices of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange and the common stock issuable in exchange for the Optional Exchange Principal Amount or upon conversion of the Series B-2 Preferred Stock would be 1,777,437 shares of common stock.

As of December 31, 2019, 1,576 shares of Series B-1 Preferred Stock have been converted into 103,749 shares of common stock, and there were no shares of Series B-2 Preferred Stock outstanding.

2021 Note Exchange Effected in December 2019

The December 2019 Notes bear interest at 6.75% per annum. The December 2019 Notes are convertible into shares of the Company’s common stock at an initial conversion price of $17.11 per share (which represents the conversion price of the 2021 Notes), subject to adjustment in accordance with the terms of the December 2019 Notes. As of the date of issuance, the December 2019 Notes were convertible, by their terms, into an aggregate of 4,174,051 shares of the Company’s common stock. The Company subsequently amended the December 2019 Notes to provide that such notes shall be convertible into shares of the Company’s common stock at a conversion price of $5.85 per share (which represents the conversion price of the Deerfield Convertible Note). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the December 2019 Notes became $273.76 per share and the aggregate shares which the December 2019 Notes were convertible became 260,876. The conversion price of the December 2019 Notes will be adjusted downward if the Company issues or sells any shares of common stock, convertible securities, warrants or options at a sale or exercise price per share less than the greater of the December 2019 Notes’ conversion price or the closing sale price of the Company’s common stock as reported on the NASDAQ Stock Market on the last trading date immediately prior to such issuance, or, in the case of a firm commitment underwritten offering, on the date of execution of the underwriting agreement between the Company and the underwriters for such offering. However, if the Company effects an “at the market offering” as defined in Rule 415 of the Securities Act or 1933, as amended (the “Securities Act”), of its common stock, the conversion price of the December 2019 Notes will be adjusted downward pursuant to this anti-dilution adjustment only if such sales are made at a price less than $5.85 per share, provided that this anti-dilution adjustment will not apply to any sales made under (x) the Purchase Agreement, (y) the Second ATM Agreement, or (z) the September 2019 Exchange Agreement (as amended). Notwithstanding anything in the contrary in the December 2019 Notes, the anti-dilution adjustment of such notes shall not result in the conversion price of the December 2019 Notes being less than $0.583 per share. The December 2019 Notes are convertible at any time at the option of the holders thereof, provided that a holder of a December 2019 Note is prohibited from converting such note into shares of the Company’s common stock if, as a result of such conversion, such holder (together with certain affiliates and “group” members) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. However, the December 2019 Note issued to DSC, due to the fact DSC was a beneficial owner of more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding, has a beneficial ownership cap equal to 19.985% of the total number of shares of the Company’s common stock then issued and outstanding. Pursuant to the December 2019 Notes, the December 2019 Holders have the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon, in connection with a Major Transaction (as defined in the December 2019 Notes), which shall include, among others, any acquisition or other change of control of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time after March 31, 2021, shares of the Company’s common stock are not listed on an Eligible Market (as defined in the December 2019 Notes). The December 2019 Notes are subject to specified events of default, the occurrence of which would entitle the December 2019 Holders to immediately demand repayment of all outstanding principal and accrued interest on the December 2019 Notes. Such events of default include, among others, failure to make any payment under the December 2019 Notes when due, failure to observe or perform any covenant under the Deerfield Facility Agreement (as defined below) or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgement levied against the Company and a material default by the Company under the Deerfield Warrant, the December 2019 Notes or the Deerfield Convertible Note.

The December 2019 Exchange Agreement also amends and restates the Deerfield Convertible Note to conform the definitions of “Eligible Market” and “Major Transactions” to the definition in the December 2019 Notes, to remove provisions that were only applicable prior to the Company’s initial public offering and to make certain other changes to conform to the December 2019 Notes. The conversion price for the Deerfield Convertible Note remains $5.85 per share, subject to adjustment on the same basis as the existing senior secured convertible notes, but subject to a floor price of $0.583. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Deerfield Convertible Note became $93.60 per share and the floor price became $9.328.

In connection with entering into the December 2019 Exchange Agreement, the Company also entered into an amendment (the “September 2019 Exchange Agreement Amendment”) to the September 2019 Exchange Agreement to, among other things, (i) amend and restate Annex I of the September 2019 Exchange Agreement to allow the Deerfield Lenders to effect optional exchanges of the December 2019 Notes and the Deerfield Convertible Note under the terms of the September 2019 Exchange Agreement; (ii) amend the common stock exchange price under the September 2019 Exchange Agreement to be a per share price equal to the greater of (x) $0.60, subject to adjustment to reflect stock splits and similar events, or (y) the average of the volume-weighted average prices of the Company’s common stock on the NASDAQ Stock Market on each of the 15 trading days immediately preceding such exchange, (iii) provide that no more than 28,439,015 of shares of the Company’s common stock shall be issued pursuant to optional exchanges under the September 2019 Exchange Agreement (whether by common stock exchange or upon conversion of Series B-2 Shares (as defined in the September 2019 Exchange Agreement Amendment)), subject to adjustment to reflect stock splits and similar events and (iv) eliminate limitations regarding the timing and aggregate amount of principal which may be exchanged under the September 2019 Exchange Agreement. These changes in the September 2019 Exchange Agreement Amendment significantly modified the Optional Exchange Principal Amount, as such after giving effect to the September Exchange Agreement Amendment the Optional Exchange Principal Amount ceases to exist the new optional exchanges are referred to as the Deerfield Optional Conversion Feature. Effected for the 1-for-16 reverse stock split in December 2020 the exchange price of the Deerfield Optional Conversion Feature would be $9.60 per share or the average of the volume-weighted average prices of the Company’s common stock on the Nasdaq Stock Market on each the 15 trading days immediately preceding such exchange, and the aggregate shares for which the Deerfield Optional Conversion Feature was convertible would be 1,777,437 shares of common stock.

In connection with entering into the September 2019 Amendment, the Company filed an amendment to the Series B-2 Certificate of Designation (the “Series B-2 Certificate of Designation Amendment”) with the Secretary of State of the State Delaware. The Series B-2 Certificate of Designation Amendment provides that each share of the Company’s Series B-2 preferred stock is convertible into shares of the Company’s common stock at a per share price equal to the common stock exchange price under the September 2019 Exchange Agreement, which equals the greater of (i) $0.60 (subject to adjustment to reflect stock splits and similar events), or (ii) the average of the volume-weighted average prices of the Company’s common stock on the NASDAQ Stock Market on each of the 15 trading days immediately preceding such exchange.

As of December 31, 2019, the Deerfield Lenders have converted $1.2 million of principal under the December 2019 Notes into 125,000 shares of common stock.

2021 Note Exchange Effected in January 2020

In January 2020, we entered into the January 2020 Exchange Agreement (the “January 2020 Exchange Agreement”) with M. Kingdon Offshore Master Fund, LP (“Kingdon”). Under the January 2020 Exchange Agreement, the Company issued a senior secured convertible note in the aggregate principal amount of $3,037,354 (the “January 2020 Note”) in exchange for the cancellation of an aggregate of $3,037,354 principal amount and accrued interest of the 2021 Note then owned by Kingdon. Upon entering into the January 2020 Exchange Agreement, the Company agreed to pay Kingdon an interest payment of $37,354, which represents 50% of the accrued and unpaid interest, as of January 13, 2020, on Kingdon’s 2021 Note. The remainder of such interest was included in the principal amount of the January 2020 Note.

The January 2020 Note was issued with substantially the same terms and conditions as the December 2019 Notes (as amended by the amendment described in more detail below).

In connection with entering into the January 2020 Exchange Agreement, the Company entered into an Amendment to Facility Agreement and December 2019 Notes and Consent (the “December 2019 Note Amendment”) with the December 2019 Holders that, among other things, (i) amended the December 2019 Notes to (a) reduce the Conversion Price (as defined in the December 2019 Notes) from $17.11 to $5.85 per share and (b) increased the Floor Price (as defined in the December 2019 Notes) from $0.38 to $0.583 per share, and (ii) amended the Deerfield Facility Agreement to (x) provide for Kingdon to join the Deerfield Facility Agreement as a Lender (as defined in the Deerfield Facility Agreement) and (y) provide that the 2020 Note and shall constitute a “Senior Secured Convertible Note” (as defined in the Deerfield Facility Agreement) for purposes of the Deerfield Facility Agreement and other Transaction Documents (as defined in the Deerfield Facility Agreement). After giving effect to the Reverse Stock Split effected in December 2020, the Conversion Price became $93.60 per share and the Floor Price became $9.328.

Convertible Notes

Future minimum principal payments under convertible notes as of December 31, 2019, were as follows (in thousands):


Year Ending December 31,	Convertible Notes
2020	$	—
2021		80,199

Total minimum principal payments		80,199

Less: debt issuance costs and discounts		(2,856	)

Convertible notes, net	$	77,343

Line of Credit

During the second quarter of 2016, the Company opened a line of credit to support several irrevocable letters of credit. In March 2019, the line of credit was closed. The irrevocable letters of credit and associated money market account remain and the money market account is reported as restricted cash on the balance sheets.

Commitments and Contingencies

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Commitments and Contingencies Disclosure [Text Block]

D.	Commitments and Contingencies

From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates. As of September 30, 2020 and December 31, 2019, no accruals have been made related to commitments and contingencies.

H.	Commitments and Contingencies

Legal Matters

From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates. As of December 31, 2019 and 2018, no accruals have been made related to commitments and contingencies.

Lease Agreements

We have operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. Our leases have remaining lease terms of 1 year to 6 years, some of which include options to extend the leases for up to 5 years, and some which include options to terminate the leases within 1 year.

Florida

The Company leases office space in Florida, comprised of two contiguous office suites, under non-cancelable operating leases, which expire in August 2025 and February 2026, as to each space respectively, and include the right to extend the term of the leases for two successive five-year terms upon expiration. In February 2020, the Company agreed to sublease office space in Florida, comprised of one of the two contiguous suites, under a non-cancelable operating lease, which expires in February 2026.

Iowa

The Company leases office and laboratory facilities in Iowa under a non-cancelable operating lease. The Company’s lease for its Iowa facilities expires in September 2020 and includes a renewal option that could extend the lease for successive one-year terms upon expiration.

Virginia

The Company leases office and laboratory facilities in Virginia under a non-cancelable operating lease. The Company’s lease for its Virginia facilities expires in August 2020.

North Carolina

The Company leased office space in North Carolina under a non-cancelable operating lease. The original expiration date of the Company’s lease was May 2020. During the second quarter of 2017, the Company subleased its office space in North Carolina under a non-cancelable operating lease to a third-party tenant. The sublease term with the third-party runs concurrent with the lease term the Company has with the landlord. In October 2019, the Company terminated the head lease with the landlord and the sublease with the subtenant so that the landlord and subtenant could enter directly into a lease.

Capital Lease

The Company leases various laboratory equipment, furniture and office equipment and leasehold improvements that are accounted for as capital leases and that require ongoing payments, including interest expense. The capital leases are financed through various financial institutions and are collateralized by the underlying assets. As of December 31, 2019 and 2018, the interest rates for assets under remaining capital leases range from 7.19% to 9.57%.

The components of lease expense were as follows (in thousands):


Lease Cost	Year Ended December 31, 2019
Finance lease cost:
Amortization of right-of-use assets	$	123
Interest on lease liabilities		40

Total finance lease cost		163
Operating lease cost		473
Short-term lease cost		232
Variable lease cost		48
Less: sublease income		(84	)

Total lease costs	$	832

Rent expense for non-cancelable operating leases was $0.7 million for the year ended December 31, 2019 and 2018.

Supplemental cash flow information related to leases was as follows (in thousands):


	Year Ended December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	40
Financing cash flows from finance leases		207
Operating cash flows from operating leases		435
Operating cash flows from short-term leases		232
Operating cash flows from variable lease costs		48

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	757
Operating leases		1,852

Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate):


	December 31, 2019
Finance Leases
Property and equipment, at cost	$	1,013
less: accumulated depreciation and amortization		(398	)

Property and equipment, net	$	615

Other current liabilities	$	236
Other long-term liabilities		168

Total finance lease liabilities	$	404


Operating Leases
Operating lease right-of-use assets	$	1,537

Total operating lease right-of-use assets		1,537
Current portion of operating lease liabilities		284
Operating lease liabilities, less current portion		1,901

Total operating lease liabilities	$	2,185


Weighted Average Remaining Lease Term
Finance leases		2 years
Operating leases		6 years

Weighted Average Discount Rate
Finance leases		7.7	%
Operating leases		7.5	%

Maturities on lease liabilities were as follows (in thousands):


Year Ending December 31,	Finance Leases			Operating Leases
2020	$	260		$	438
2021		163			449
2022		11			461
2023		—			472
2024		—			484
Thereafter		—			420

Total lease payments		434			2,724
Less: future interest expense		(30	)		(539	)

Lease liabilities	$	404		$	2,185

Supply Arrangement

12 Months Ended

Dec. 31, 2019

Collaborative Arrangement Disclosure [Text Block]

I.	Supply Arrangement

As of December 31, 2019 and 2018, the Company has one manufacturing arrangement that involves potential future expenditures related to research and development.

In November 2009, the Company entered into a supply agreement (the “Supply Agreement”) with Johnson Matthey Inc. (“JMI”) whereby JMI has agreed to supply the Company with all of the benzhydrocodone necessary for clinical trials and commercial sale for a price equal to JMI’s manufacturing cost and to provide process optimization and development services for benzhydrocodone. The Company’s FDA-approved drug, APADAZ, contains benzhydrocodone. Expense of $3.2 million and $3.6 million was recorded under this agreement for the year ended December 31, 2019, respectively. The Company must purchase all of its U.S. benzhydrocodone needs from JMI and JMI cannot supply benzhydrocodone to other companies. The term of the Supply Agreement extends as long as the Company holds a valid and enforceable patent for benzhydrocodone or until the tenth anniversary of a commercial launch of a FDA-approved drug incorporating benzhydrocodone, whichever date is later. Upon the expiration of such term, the agreement will automatically renew for a period of two years unless either party provides 12 months prior notice of its intent not to renew. Under the agreement, JMI will receive a tiered-based royalty share on the net sales on the commercial sale of a FDA-approved drug incorporating benzhydrocodone. No reliable estimate of the future payments can be made at this time.

Preferred Stock and Warrants

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Preferred Stock [Text Block]

E.	Preferred Stock and Warrants

Authorized, Issued, and Outstanding Preferred Stock

As of September 30, 2020 and December 31, 2019, the Company had 10,000,000 shares of authorized preferred stock, of which 9,578 shares were designated as Series A Preferred Stock, 1,576 shares were designated as Series B-1 Preferred Stock and 27,000 shares were designated as Series B-2 Preferred Stock. Of the designated preferred stock 9,577 shares of Series A Preferred Stock and 1,576 shares of Series B-1 Preferred Stock were issued as of September 30, 2020 and December 31, 2019. No shares of Series A Preferred Stock or Series B-1 Preferred Stock were outstanding as of September 30, 2020 and December 31, 2019. No shares of Series B-2 Preferred Stock were issued or outstanding as of September 30, 2020 and December 31, 2019.

In October 2018, the Company entered into the October 2018 Exchange Agreement. Under the October 2018 Exchange Agreement the Company issued to the Holders 9,577 shares of Series A Preferred Stock. Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the Series A Preferred Stock (without giving effect to the limitation on conversion described below), and as of September 30, 2020 all issued shares of Series A Preferred Stock had been converted into shares of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 and the shares of common stock issuable upon conversion of the Series A Preferred stock would be 199,519 shares of common stock.

In September 2019, the Company entered into the September 2019 Exchange Agreement. Under the September 2019 Exchange Agreement the Company issued to the Holders 1,576 shares of Series B-1 Preferred Stock. Each share of Series B-1 Preferred Stock had an aggregate stated value of $1,000 and was convertible into shares of common stock at a price equal to the greater of (i) $0.9494, or (ii) the average of the volume-weighted average price of the Common Stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the September 2019 Exchange Agreement, there were an aggregate of 1,659,996 shares of common stock issuable upon conversion of the Series B-1 Preferred Stock (without giving effect to the limitation on conversion described below). Effected for the 1-for-16 reverse stock split in December 2020 the conversion price of the Series B-1 Preferred Stock would be $15.1904 or the average of the volume-weighted average price of the common stock on the principal securities exchange or trading market on which the common stock is then trading on each of the 15 trading days immediately preceding such exchange and the shares of common stock issuable upon conversion of the Series B-1 Preferred Stock would be 103,749 shares of common stock. The Series B Preferred Stock is convertible at any time at the option of the Holders; provided that the Holders are prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such Holders (together with certain affiliates and “group” members of such Holders) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. The Series B Preferred Stock is not redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Holders will receive an amount equal to $0.0001 per share, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock and with the holders of any shares of any other class or series of capital stock of the Company entitled to share in such remaining assets of the Company (including Series A Preferred Stock on an as-converted basis. With respect to rights upon liquidation, the Series B Preferred Stock ranks senior to the common stock, on parity with the Series A Preferred Stock, if any is then outstanding, and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that materially and adversely affect the holders of Series B Preferred Stock), the Series B Preferred Stock does not have voting rights. The Series B Preferred Stock is not subject to any price-based anti-dilution protections and does not provide for any accruing dividends, but provides that holders of Series B Preferred Stock will participate in any dividends on the common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Series B-1 Certificate of Designation and the Series B-2 Certificate of Designation also provide for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-1 Preferred Stock or Series B-2 Preferred Stock, respectively, into Common Stock in accordance with the applicable Certificate of Designation. As of September 30, 2020 all issued shares of Series B-1 Preferred Stock have been converted into shares of common stock.

J.	Preferred Stock and Warrants

Authorized, Issued, and Outstanding Preferred Stock

As of December 31, 2019, the Company had 10,000,000 shares of authorized preferred stock, of which 9,578 shares were designated as Series A Preferred Stock, 1,576 shares were designated as Series B-1 Preferred Stock and 27,000 shares were designated as Series B-2 Preferred Stock. Of the designated preferred stock 9,577 shares of Series A Preferred Stock and 1,576 shares of Series B-1 Preferred Stock were issued as of December 31, 2019. No shares of Series A Preferred Stock or Series B-1 Preferred Stock were outstanding as of December 31, 2019. As of December 31, 2018, 9,577 shares of Series A Preferred Stock were issued and 3,337 were outstanding and no shares of Series B-1 Preferred stock were authorized, issued or outstanding. No shares of Series B-2 Preferred Stock were issued or outstanding as of December 31, 2019 or December 31, 2018 and no shares were authorized as of December 31, 2018.

In October 2018, the Company entered into the October 2018 Exchange Agreement. Under the October 2018 Exchange Agreement the Company issued to the Holders 9,577 shares of Series A Preferred Stock. Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the Series A Preferred Stock (without giving effect to the limitation on conversion described below), and as of December 31, 2019 all issued shares of Series A Preferred Stock had been converted into shares of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 per share and the aggregate shares of common stock issuable upon conversion of the Series A Preferred Stock would be 199,519 shares.

In September 2019, the Company entered into the September 2019 Exchange Agreement. Under the September 2019 Exchange Agreement the Company issued to the Holders 1,576 shares of Series B-1 Preferred Stock. Each share of Series B-1 Preferred Stock had an aggregate stated value of $1,000 and was convertible into shares of common stock at a price equal to the greater of (i) $0.9494, or (ii) the average of the volume-weighted average price of the Common Stock on the principal securities exchange or trading market on which the Common Stock is then trading on each of the 15 trading days immediately preceding such exchange (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the September 2019 Exchange Agreement, there were an aggregate of 1,659,996 shares of common stock issuable upon conversion of the Series B-1 Preferred Stock (without giving effect to the limitation on conversion described below). Effected for the 1-for-16 reverse stock split in December 2020 the conversion price of the Series B-1 Preferred Stock would be $15.1904 per share and the aggregate shares of common stock issuable upon conversion of the Series B-1 Preferred Stock would be 103,749 shares. The Series B Preferred Stock is convertible at any time at the option of the Holders; provided that the Holders are prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such Holders (together with certain affiliates and “group” members of such Holders) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. The Series B Preferred Stock is not redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Holders will receive an amount equal to $0.0001 per share, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock and with the holders of any shares of any other class or series of capital stock of the Company entitled to share in such remaining assets of the Company (including Series A Preferred Stock on an as-converted basis. With respect to rights upon liquidation, the Series B Preferred Stock ranks senior to the common stock, on parity with the Series A Preferred Stock, if any is then outstanding, and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that materially and adversely affect the holders of Series B Preferred Stock), the Series B Preferred Stock does not have voting rights. The Series B Preferred Stock is not subject to any price-based anti-dilution protections and does not provide for any accruing dividends, but provides that holders of Series B Preferred Stock will participate in any dividends on the common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Series B-1 Certificate of Designation and the Series B-2 Certificate of Designation also provide for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-1 Preferred Stock or Series B-2 Preferred Stock, respectively, into Common Stock in accordance with the applicable Certificate of Designation. As of December 31, 2019, 1,576 shares of Series B-1 Preferred Stock have been converted into 103,749 shares of common stock.

Common Stock and Warrants

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Stockholders' Equity Note Disclosure [Text Block]

F.	Common Stock and Warrants

Authorized, Issued, and Outstanding Common Shares

As of September 30, 2020 and December 31, 2019, the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized shares, 4,532,039 and 2,271,833 shares of common stock were issued and outstanding as of September 30, 2020 and December 31, 2019, respectively.

As of September 30, 2020 and December 31, 2019, the Company had reserved authorized shares of common stock for future issuance as follows:


	September 30, 2020		December 31, 2019
Conversion of Deerfield Convertible Note		79,748		75,850
Conversion of 2021 Notes		—		10,958
Conversion of January 2020 Note		34,037		—
Conversion of December 2019 Notes not subject to the Deerfield Optional Conversion Feature		615,307		199,172
Outstanding awards under equity incentive plans		354,379		324,473
Outstanding common stock warrants		151,442		151,442
In exchange for the Deerfield Optional Conversion Feature*		—		1,652,437
Possible future issuances under the equity line of credit		—		597,065
Possible future issuances under equity incentive plans		50,273		5,325

Total common shares reserved for future issuance		1,285,186		3,016,722

*	Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature

Common Stock Activity

The following table summarizes common stock activity for the nine months ended September 30, 2020:


	Shares of Common Stock
Balance as of December 31, 2019		2,271,833
Common stock issued under equity line of credit		269,289
Restricted stock vested during the period		3,806
Common stock issued as compensation to third-parties		2,484
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		1,000,000

Balance as of March 31, 2020		3,547,412

Common stock issued under equity line of credit		309,971
Restricted stock vested during the period		4,015
Common stock issued as compensation to third-parties		11,873
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		328,125

Balance as of June 30, 2020		4,201,396

Restricted stock vested during the period		1,384
Common stock issued as compensation to third-parties		4,668
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		324,312
Common stock issued as a result of stock option exercise		279

Balance as of September 30, 2020		4,532,039

Warrants

On June 2, 2014, pursuant to the terms of the Deerfield Facility Agreement, the Company issued the Deerfield Warrant to purchase 14,423,076 shares of Series D Preferred (Note E). The Company recorded the fair value of the Deerfield Warrant as a debt discount and a warrant liability. The Deerfield Warrant, if unexercised, expires on the earlier of June 2, 2024, or upon a liquidation event. Upon completion of the Company’s initial public offering (the “IPO”), the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 and the shares of the Company’s common stock issuable upon exercise of the Deerfield Warrant became 120,192 shares of common stock. The Company is amortizing the debt discount over the term of the Deerfield Convertible Note and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the unaudited condensed statements of operations.

The Company determined that the Deerfield Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the Deerfield Warrant automatically converted into warrants to purchase the Company’s common stock. The Deerfield Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the unaudited condensed statements of operations as a fair value adjustment (Note H).

In connection with a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”), in October 2018, the Company issued to KVK a warrant to purchase up to 500,000 shares of common stock of the Company at an exercise price of $2.30 per share, which reflected the closing price of the Company’s common stock on the NASDAQ Stock Market on the execution date of the APADAZ License Agreement (the “KVK Warrant”). The KVK Warrant is initially not exercisable for any shares of common stock. Upon the achievement of each of four specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional 125,000 shares, up to an aggregate of 500,000 shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until October 24, 2023. Upon exercise, the aggregate exercise price may be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise. Effected for the 1-for-16 reverse stock split in December 2020 the exercise price of the KVK Warrant became $36.80 and the shares of common stock issuable upon exercise of the KVK Warrant became 31,250 shares of common stock.

The Company determined that, since KVK qualifies as a customer under ASC 606, the KVK Warrant should be recorded as a contract asset and recognized as contra-revenue as the Company recognizes revenue from the APADAZ License Agreement. In addition, the Company determined that the KVK Warrant qualifies as a derivative under ASC 815 and should be recorded as a liability and stated at fair value each reporting period. The Company calculates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option pricing model. Changes in fair value resulting from changes in the inputs to the Black Scholes model are accounted for as changes in the fair value of the derivative under ASC 815 and are recorded as fair value adjustment related to derivative and warrant liability in the statements of operations. Changes in the number of shares that are expected to be issued are treated as changes in variable consideration under ASC 606 and are recorded as a change in contract asset in the balance sheets.

K.	Common Stock and Warrants

Authorized, Issued, and Outstanding Common Shares

As of December 31, 2019 and 2018, the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized shares, 2,271,833 and 1,653,376 shares of common stock were issued and outstanding as of December 31, 2019 and 2018, respectively.

As of December 31, 2019 and 2018, the Company had reserved authorized shares of common stock for future issuance as follows:


	December 31,
	2019		2018
Conversion of Deerfield Convertible Note		75,850		72,975
Conversion of 2021 Notes		10,958		280,072
Conversion of 2019 Notes not subject to the Deerfield Optional Conversion Feature		199,172		—
Outstanding awards under equity incentive plans		324,473		231,493
Outstanding common stock warrants		151,442		157,957
Conversion of Series A Preferred Stock		—		69,521
In exchange for the Deerfield Optional Conversion Feature*		1,652,437		—
Possible future issuances under the Prior Purchase Agreement		597,065		—
Possible future issuances under equity incentive plans		5,325		40,557

Total common shares reserved for future issuance		3,016,722		852,575

Common Stock Activity

The following table summarizes common stock activity for the years ended December 31, 2019 and 2018:


	Shares of Common Stock
Balance as of January 1, 2018		916,021

Common stock sold under First ATM Agreement		47,638
Common stock issued as a result of Deerfield Convertible Note principal and interest conversion		37,410
Common stock options exercised		1,476
Common stock sold under underwritten public offering		520,833
Common stock issued as a result of Series A Preferred Stock conversion		129,998

Balance as of December 31, 2018		1,653,376

Common stock issued under the Prior Purchase Agreement		220,091
Restricted stock vested during the period		6,354
Common stock issued as a result of 2021 Notes principal conversion		93,742
Common stock issued as a result of Series B-1 Preferred Stock conversion		103,749
Common stock issued as a result of Series A Preferred Stock conversion		69,521
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		125,000

Balance as of December 31, 2019		2,271,833

In September 2018, the Company terminated the First ATM Agreement with Cowen. Prior to termination of the First ATM Agreement, the Company sold an aggregate of 47,638 shares of common stock under the First ATM Agreement resulting in gross proceeds to the Company of $4.9 million. As of December 31, 2019, the Company has not sold any shares of common stock under the Second ATM Agreement. Refer to Note A for a further discussion of the First and Second ATM Agreements.

In October 2018, the Company entered into an underwriting agreement with RBCCM pursuant to which the Company issued and sold 520,833 shares of common stock of the Company in an underwritten public offering pursuant to the Company’s registration statement on Form S-3. Refer to Note A for a further discussion of the underwritten public offering.

Also in October 2018, the Company entered into the October 2018 Exchange Agreement pursuant to which the Company issued to the Holders 9,577 shares of Series A Preferred Stock. As of December 31, 2019, 9,577 shares of Series A Preferred Stock have been converted into 199,519 shares of common stock. Refer to Note G for a further discussion of the October 2018 Exchange Agreement.

On September 3, 2019, the Company entered into the September 2019 Exchange Agreement pursuant to which the Company issued to the Holders 93,742 shares of common stock and 1,576 shares of Series B-1 Preferred Stock. As of December 31, 2019, 1,576 shares of Series B-1 Preferred Stock have been converted into 103,749 shares of common stock. Refer to Note G for a further discussion of the September 2019 Exchange Agreement.

Warrants

During 2013, the Company issued $3.8 million of convertible notes and the warrants (the “2013 Warrants”) to purchase 1,079,453 shares of equity securities in a future financing meeting specified requirements (a “Qualified Financing”). The 2013 Warrants allow the holders to purchase shares of the same class and series of equity securities issued in the Qualified Financing for an exercise price equal to the per share price paid by the purchasers of such equity securities in the Qualified Financing. When the Company entered into the Deerfield Facility Agreement, the 2013 Warrants became warrants to purchase 1,079,453 shares of Series D Preferred. Upon completion of the IPO, the 2013 Warrants automatically converted into warrants to purchase 143,466 shares of the Company’s common stock at an exercise price of $5.85 per share. The 2013 Warrants expired on June 2, 2019. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the 2013 Warrants became $93.60 per share and the aggregate shares of common stock issuable upon conversion of the 2013 Warrants would be 8,966 shares.

On June 2, 2014, pursuant to the terms of the Deerfield Facility Agreement, the Company issued the Deerfield Warrant to purchase 14,423,076 shares of Series D Preferred (Note G). The Company recorded the fair value of the Deerfield Warrant as a debt discount and a warrant liability. The Deerfield Warrant, if unexercised, expires on the earlier of June 2, 2024, or upon a liquidation event. Upon completion of the IPO, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. The Company is amortizing the debt discount over the term of the Deerfield Convertible Note and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the condensed statements of operations. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 per share and the aggregate shares of common stock issuable upon exercise of the Deerfield Warrants became 120,192 shares.

The Company determined that the 2013 Warrants and Deerfield Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the 2013 Warrants and the Deerfield Warrant automatically converted into warrants to purchase the Company’s common stock. The Company marked the 2013 Warrants to fair value and reclassified them to equity upon closing of the IPO. The Deerfield Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the condensed statements of operations as a fair value adjustment (Note M).

In connection with a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”), in October 2018, the Company issued to KVK a warrant to purchase up to 500,000 shares of common stock of the Company at an exercise price of $2.30 per share, which reflected the closing price of the Company’s common stock on the NASDAQ Stock Market on the execution date of the APADAZ License Agreement (the “KVK Warrant”). The KVK Warrant is initially not exercisable for any shares of common stock. Upon the achievement of each of four specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional 125,000 shares, up to an aggregate of 500,000 shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until October 24, 2023. Upon exercise, the aggregate exercise price may be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise. Effected for 1-for-16 reverse stock split in December 2020 the exercise price of the KVK Warrant became $36.80 per share and the aggregate shares of common stock issuable upon exercise of the KVK Warrant became 31,250 shares.

Stock-based Compensation

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Share-based Payment Arrangement [Text Block]

G.	Stock-Based Compensation

The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO.

In November 2014, the Board of Directors of the Company (“the Board”), and in April 2015, the Company’s stockholders, approved the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. The maximum number of shares of common stock that may be issued under the 2014 Plan is 408,167 as of September 30, 2020. The number of shares of common stock reserved for issuance under the 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2016, and ending on and including January 1, 2024, by 4% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the 2014 Plan, on January 1, 2020, the common stock reserved for issuance under the 2014 Plan automatically increased by 90,876 shares.

During 2020, the Company granted to certain consultants fully vested restricted stock awards (“RSAs”) under the 2014 Plan. The RSAs were granted as compensation in accordance with each consultants consulting agreement for services performed during 2020. For the three and nine months ended September 30, 2020, RSAs were granted for a total of 1,384 and 9,205 shares of common stock.

During the second quarter of 2019, the Company granted to each non-employee member of the Company’s board of directors (each a “non-employee Director”) two separate fully vested RSAs under the 2014 Plan. The RSAs were granted in lieu of the quarterly cash compensation payable under the Company’s Third Amended and Restated Non-Employee Director Compensation Policy to each non-employee Director for service as a member of the Company’s board of directors, and applicable committees thereof, for the first and second quarters of 2019. For the three and nine months ended September 30, 2019, RSAs were granted for a total of 5,104 shares of common stock. No RSAs were granted during the three months ended September 30, 2019.

During the three and nine months ended September 30, 2020, stock options were exercised for a total of 279 shares of common stock. No stock options were exercised during the three and nine months ended September 30, 2019.

Stock-based compensation expense recorded under the Incentive Stock Plan and the 2014 Plan is included in the following line items in the accompanying condensed statements of operations (in thousands):


	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019
Research and development	$	157	$	400	$	748	$	1,196
General and administrative		228		657		866		2,468
Severance expense		—		—		420		—

Total stock-based compensation expense	$	385	$	1,057	$	2,034	$	3,664

There was $0.3 million of stock-based compensation expense related to performance-based awards recognized during the three and nine months ended September 30, 2020. There was no stock-based compensation expense related to performance-based awards recognized during the three months ended September 30, 2020 or the three and nine months ended September 30, 2019.

L.	Stock-Based Compensation

The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO.

In November 2014, the Board of Directors of the Company (“the Board”), and in April 2015, the Company’s stockholders, approved the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. The maximum number of shares of common stock that may be issued under the 2014 Plan is 317,291 as of December 31, 2019. The number of shares of common stock reserved for issuance under the 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2016, and ending on and including January 1, 2024, by 4% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the 2014 Plan, on January 1, 2020, the common stock reserved for issuance under the 2014 Plan automatically increased by 90,876 shares.

During the second quarter of 2019, the Company granted to each non-employee member of the Company’s board of directors (each a “non-employee Director”) two separate fully vested restricted stock awards (“RSAs”) under the 2014 Plan. The RSAs were granted in lieu of the quarterly cash compensation payable under the Company’s Third Amended and Restated Non-Employee Director Compensation Policy to each non-employee Director for service as a member of the Company’s board of directors, and applicable committees thereof, in the first and second quarters of 2019. For the first and second quarter of 2019, RSAs were granted for a total of 2,650 and 2,454 shares of common stock, respectively.

In addition, the Company granted to a consultant fully vested RSAs under the 2014 Plan. The RSAs were granted as part of the monthly compensation package to the consultant for services performed. As of December 31, 2019, RSAs were granted for a total of 1,250 shares of common stock for this purpose.

During the year ended December 31, 2019 no stock options were exercised. During the year ended December 31, 2018, stock options to acquire 1,476 shares of common stock were exercised for approximately $68,000 with an intrinsic value of approximately $69,000.

Stock-based compensation expense recorded under the Incentive Stock Plan and the 2014 Plan is included in the following line items in the accompanying statements of operations (in thousands):


	Year ended December 31,
	2019		2018
Research and development	$	1,459	$	1,608
General and administrative		2,951		3,651
Severance expense		—		1,236

Total stock-based compensation expense	$	4,410	$	6,495

Stock Option Awards

The Company estimates the fair value of stock options using the Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the option, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the option. The expected term represents the period of time the stock options are expected to be outstanding. Due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected term of the stock options, the Company uses the simplified method to estimate the expected term for its “plain vanilla” stock options. Under the simplified method, the expected term of an option is presumed to be the mid-point between the vesting date and the end of the contractual term. Some options, for example those that have exercise prices in excess of the fair value of the underlying stock, are not considered “plain vanilla” stock options. For these options, the Company uses an expected term equal to the contractual term of the option. Expected volatility for options granted prior to the second anniversary of the IPO is based on a blend of historical volatilities for publicly traded stock of comparable companies and the Company over the estimated expected term of the stock options. For options granted after the second anniversary of the IPO, expected volatility is based on the Company’s historical volatility over the estimated expected term of the stock options. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends.

The Company recognizes compensation expense related to stock-based payment transactions upon satisfaction of the requisite service or vesting requirements. Forfeitures are estimated at the time of grant and revised based on actual forfeitures, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

Using the Black-Scholes option-pricing model, the weighted-average fair value of awards granted during the years ended December 31, 2019 and 2018, fair value was $1.43 and $4.05 per share, respectively. After giving effect to the Reverse Stock Split effected in December 2020, the fair values became $22.88 and $64.80 per share, respectively. The assumptions used to estimate fair value are as follows:


	Year Ended December 31,
	2019	2018
Risk-free interest rate	1.75% - 2.61%	2.43% - 2.91%
Expected term (in years)	5.50 - 10.00	5.50 - 6.79
Expected volatility	84.82% - 85.93%	83.10% - 85.05%
Expected dividend yield	0%	0%

The activity under the Incentive Stock Plan and the 2014 Plan for the year ended December 31, 2019, is summarized as follows:


	Number of Options			Weighted Average Exercise Price		Weighted Avg Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding balance at January 1, 2019		231,477		$	149.62		7.48	$	—
Granted		143,223		$	29.30
Exercised or released		(6,354	)	$	—
Canceled or forfeited		(42,209	)	$	140.81
Expired		(1,664	)	$	76.80

Outstanding balance at December 31, 2019		324,473		$	100.96		7.63	$	—

Exercisable at December 31, 2019		134,614		$	172.84		6.04	$	—

Vested and expected to vest at December 31, 2019		281,356		$	114.56		7.30	$	—

Information regarding currently outstanding and exercisable options as of December 31, 2019, is as follows:


	Options Outstanding				Options Exercisable
Exercise Price	Number of Shares		Weighted Avg Remaining Contractual Term		Number of Shares		Weighted Avg Remaining Contractual Term
$8.2576 to $80.00		181,415		8.72		29,920		7.19
$80.01 to $160.00		68,914		6.74		37,478		5.62
$160.01 to $240.00		29,489		5.94		23,821		5.90
$240.01 to $320.00		23,719		5.70		22,459		5.67
$320.01 to $327.20		20,936		5.68		20,936		5.68

		324,473		7.63		134,614		6.04

The total fair value of stock options vested during the years ended December 31, 2019 and 2018, was $4.9 million and $5.9 million, respectively.

Unvested stock options as of December 31, 2019 and 2018, were as follows:


	Number of Unvested Shares
	December 31,
Exercise Price	2019		2018
$8.2576 to $80.00		151,495		39,646
$80.01 to $160.00		31,436		51,165
$160.01 to $240.00		5,668		11,659
$240.01 to $320.00		1,260		8,740
$320.01 to $327.20		—		5,432

Total number of unvested stock options		189,859		116,642

As of December 31, 2019, there was $3.8 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the 2014 Plan. That compensation cost is expected to be recognized over a weighted-average period of 2.29 years.

There was no stock-based compensation expense related to performance-based awards recognized during the years ended December 31, 2019 or 2018.

Fair Value of Financial Instruments

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Fair Value Disclosures [Text Block]

H.	Fair Value of Financial Instruments

The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.

•

Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;

•

Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and

•

Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash and accounts payable and accrued expenses, approximate their respective fair values due to the short-term nature of such instruments.

The fair value of the Deerfield Convertible Note was $6.9 million and $6.0 million, respectively, as of September 30, 2020 and December 31, 2019. The fair value of the December 2019 Notes was $52.9 million and $57.0 million, respectively, as of September 30, 2020 and December 31, 2019. The fair value of the January 2020 Note was $2.9 million as of September 30, 2020 and the fair value of the 2021 Notes was $2.4 million as of December 31, 2019. The Deerfield Convertible Note, December 2019 Notes, January 2020 Note and 2021 Notes fall within Level 3 of the fair value hierarchy as their value is based on the credit worthiness of the Company, which is an unobservable input. The Company used a Tsiveriotis-Fernandes model to value the Deerfield Convertible Note and December 2019 Notes as of September 30, 2020 and December 31, 2019. The Company also used a Tsiveriotis-Fernandes model to value the January 2020 Note as of September 30, 2020 and the 2021 Notes as of December 31, 2019.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of September 30, 2020 and December 31, 2019 (in thousands):


	Balance as of September 30, 2020		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	134	$	—	$	—	$	134
Embedded Warrant Put Option		19		—		—		19
Deerfield Note Put Option		—		—		—		—
KVK Warrant liability		31		—		31		—

Total liabilities	$	184	$	—	$	31	$	153


	Balance as of December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	77	$	—	$	—	$	77
Embedded Warrant Put Option		19		—		—		19
Deerfield Note Put Option		—		—		—		—
Fundamental change and make-whole interest provisions embedded within 2021 Notes		—		—		—		—
KVK Warrant liability		24		—		24		—

Total liabilities	$	120	$	—	$	24	$	96

The Company’s Deerfield Warrant liability, embedded Warrant Put Option, embedded Deerfield Note Put Option and the fundamental change and make-whole interest provisions embedded in the 2021 Notes are measured at fair value on a recurring basis. As of September 30, 2020 and December 31, 2019, the Deerfield Warrant liability, embedded Warrant Put Option and embedded Deerfield Note Put Option are reported on the unaudited condensed balance sheets in derivative and warrant liability. As of December 31, 2019, the fundamental change and make-whole interest provisions embedded in the 2021 Notes is reported on the balance sheet in derivative and warrant liability. The Company used a Monte Carlo simulation to value the Deerfield Warrant liability, embedded Warrant Put Option and the embedded Deerfield Note Put Option as of September 30, 2020 and December 31, 2019. The Company also used a Monte Carlo simulation to value the fundamental change and make-whole interest provisions embedded in the 2021 Notes as of December 31, 2019. Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the Deerfield Warrant liability, embedded Warrant Put Option and the embedded Deerfield Note Put Option are reflected in the unaudited condensed statements of operations for the three and nine months ended September 30, 2020 and 2019 as a fair value adjustment related to derivative and warrant liability. In addition, changes in the fair value of the fundamental change and make-whole interest provisions embedded in the 2021 Notes are reflected in the unaudited condensed statements of operations for the three and nine months ended September 30, 2019 as a fair value adjustment related to derivative and warrant liability.

The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of September 30, 2020 and December 31, 2019, the KVK Warrant liability is reported on the unaudited condensed balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company’s historical volatility since the IPO. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the unaudited condensed statements of operations for the three and nine months ended September 30, 2020 and 2019 as a fair value adjustment related to derivative and warrant liability.

A reconciliation of the beginning and ending balances for the derivative and warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands):


	Three months ended September 30,					Nine months ended September 30,
	2020		2019			2020		2019
Balance as of beginning of period	$	38	$	1,437		$	96	$	1,845
Adjustment to fair value		115		(1,168	)		57		(1,576	)

Balance as of end of period	$	153	$	269		$	153	$	269

M.	Fair Value of Financial Instruments

The fair value of the Deerfield Convertible Note was $6.0 million and $6.2 million, respectively, as of December 31, 2019 and 2018. The fair value of the 2021 Notes was $2.4 million and $51.2 million, respectively, as of December 31, 2019 and 2018. The fair value of the December 2019 Notes was $57.0 million as of December 31, 2019. The Deerfield Convertible Note, 2021 Notes and December 2019 Notes fall within Level 3 of the fair value hierarchy as their value is based on the credit worthiness of the Company, which is an unobservable input. The Company used a Tsiveriotis-Fernandes model to value the Deerfield Convertible Note, 2021 Notes and December 2019 Notes as of December 31, 2019 and 2018.

Assets and Liabilities Measured at Fair Value on a Recurring Basis


	Balance at December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	77	$	—	$	—	$	77
Embedded Warrant Put Option		19		—		—		19
Fundamental change and make-whole interest provisions embedded within 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		—		—		—		—
KVK Warrant liability		24		—		24		—

Total liabilities	$	120	$	—	$	24	$	96


	Balance at December 31, 2018		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	1,557	$	—	$	—	$	1,557
Embedded Warrant Put Option		154		—		—		154
Fundamental change and make-whole interest provisions embedded within 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		134		—		—		134
KVK Warrant liability		273		—		273		—

Total liabilities	$	2,118	$	—	$	273	$	1,845


Trading securities:
Certificates of deposit	$	246	$	246	$	—	$	—
U.S. Treasury securities		3,014		3,014		—		—

Total assets	$	3,260	$	3,260	$	—	$	—

The Company’s Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and the make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option, as well as the trading securities are measured at fair value on a recurring basis. As of December 31, 2019 and December 31, 2018, the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option are reported on the balance sheets in derivative and warrant liability. As of December 31, 2018, the trading securities are reported on the balance sheets in marketable securities. The Company used a Monte Carlo simulation to value the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option as of December 31, 2019 and December 31, 2018. Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option are reflected in the statements of operations for the years ended December 31, 2019 and 2018 as a fair value adjustment related to derivative and warrant liability.

The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of December 31, 2019 and December 31, 2018, the KVK Warrant liability is reported on the balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company’s historical volatility since the IPO. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the statements of operations for the years ended December 31, 2019 and 2018 as a fair value adjustment related to derivative and warrant liability.


	2019			2018
Balance as of beginning of period	$	1,845		$	7,709
Gain on extinguishment of debt		—			(2	)
Adjustment to fair value		(1,749	)		(5,862	)

Balance as of end of period	$	96		$	1,845

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Income Taxes

12 Months Ended

Dec. 31, 2019

Income Tax Disclosure [Text Block]

N.	Income Taxes

The Company’s financial statements include a total state tax benefit related to research and development credits of $22,000 and $126,000 on a loss before income taxes of approximately $24.2 million and $56.6 million for the years ended December 31, 2019 and 2018, respectively. A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows (shown as a percentage):


	Year ended December 31,
	2019			2018
Federal statutory rate		21.00			21.00
Effect of:
Change in valuation allowance		(28.52	)		(30.44	)
Return to provision and deferred true-up		—			0.38
Change in rate		(0.33	)		0.03
State tax benefit (net of federal)		3.39			4.35
Warrant liability		1.71			2.02
State research and development credit		0.09			0.22
Federal research and development credit		1.44			3.30
Amortization		(0.29	)		—
Stock-based compensation		(1.10	)		(0.63	)
Other		2.70			(0.01	)

Federal income tax provision effective rate		0.09			0.22

The components of deferred tax assets and liabilities are as follows (in thousands):


	December 31,
	2019			2018
Deferred tax assets relating to:
Net operating loss carryforwards	$	56,827		$	51,269
Research and development tax carryforward		6,411			5,657
Other deferred tax assets		4,488			3,437

Total gross deferred tax assets		67,726			60,363

Deferred tax liabilities relating to:
Property and equipment		—			161
Other deferred tax liabilities		540			10

Total gross deferred tax liabilities		540			171

Deferred tax assets less liabilities		67,186			60,192
Valuation allowance		(67,186	)		(60,192	)

Net deferred tax asset (liability)	$	—		$	—

In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based upon the level of historical taxable income and projections for future taxable income over the periods in which the deferred tax assets are deductible, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences in the future.

The Company had the following federal net operating loss carryforward and research activities credits as of December 31, 2019 (in thousands):


Year Incurred	Net Operating Loss CF		Research Activities Cr.		Expiration
2007	$	454	$	30		2027
2008		1,178		65		2028
2009		3,060		176		2029
2010		3,423		149		2030
2011		9,929		176		2031
2012		—		170		2032
2013		4,353		133		2033
2014		15,897		894		2034
2015		23,496		598		2035
2016		41,580		745		2036
2017		34,776		652		2037
2018		56,155		2,272		Indefinite
2019		22,784		352		Indefinite

	$	217,085	$	6,412

The Company also has certain state net operating loss carryforwards totaling $136.0 million that expire between 2027 and 2037. Due to potential ownership changes that may have occurred or would occur in the future, Internal Revenue Code Section 382 may place additional limitations on the Company’s ability to utilize the net operating loss carryforward.

ASC 740-10, Accounting for Uncertainty in Income Taxes, uses the term “more likely than not” to evaluate whether or not a tax position will be sustained upon examination. The Company has not identified any tax positions that do not meet the more likely than not threshold.

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

Net (Loss) Income Per Share

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Earnings Per Share [Text Block]

I.	Net (Loss) Income Per Share

Under the two-class method, for periods with net income, basic net income per share of common stock is computed by dividing the net income attributable to shares of common stock by the weighted average number of shares of common stock outstanding during the period. Net income attributable to shares of common stock is computed by subtracting from net income the portion of current period earnings that participating securities would have been entitled to receive pursuant to their dividend rights had all of the period’s earnings been distributed. No such adjustment to earnings is made during periods with a net loss as the holders of the participating securities have no obligation to fund losses. Diluted net (loss) income per share of common stock is computed under the two-class method by using the weighted average number of shares of common stock outstanding plus the potential dilutive effects of stock options and warrants. In addition, the Company analyzes the potential dilutive effect of the outstanding convertible securities under the if-converted method when calculating diluted (loss) income per share of common stock in which it is assumed that the outstanding convertible securities convert into common stock at the beginning of the period or date of issuance, if the convertible security was issued during the period. The Company reports the more dilutive of the approaches (two-class or if-converted) as its diluted net (loss) income per share of common stock during the period.

Diluted net loss per share of common stock is the same as basic net loss per share of common stock for the three and nine months ended September 30, 2020 and the nine months ended September 30, 2019 because the effects of potentially dilutive items were anti-dilutive for the respective periods. For the three months ended September 30, 2020, certain dilutive items were anti-dilutive for the period and are presented in the table immediately below. The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average number of shares of common stock outstanding because their effect is anti-dilutive:


	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019
Deerfield Convertible Note		79,748		74,557		79,748		74,557
2021 Notes*		—		1,947,924		—		1,947,924
January 2020 Note		34,037		—		34,037		—
December 2019 Notes		615,307		—		615,307		—
Awards under equity incentive plans		354,379		288,770		354,379		288,770
Common stock warrants		151,442		31,250		151,442		151,442
Series A Convertible Preferred Stock		—		—		—		69,521
Series B-1 Convertible Preferred Stock		—		—		—		51,941

Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		1,234,913		2,342,501		1,234,913		2,584,155

*	Inclusive of 1,777,437 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount.

The items which were dilutive for the three months ended September 30, 2019 are included in the reconciliation of basic net income per share of common stock to diluted net income per share of common stock below.


	Three months ended September 30, 2019
Basic net income per share of common stock:
Net income	$	3,063
Less: Net income attributable to participating securities		(348	)

Net income attributable to shares of common stock		2,715
Less: Dividends declared or accumulated		—

Undistributed net income attributable to shares of common stock, basic	$	2,715

Weighted average number of shares of common stock outstanding		1,883

Basic net income per share of common stock	$	1.44

Diluted net income per share of common stock:
Net income	$	3,063
Less: Fair value adjustment income related to Deerfield Warrant liability		(1,019	)
Less: Fair value adjustment income related to embedded Warrant Put Option		(135	)
Less: Fair value adjustment income related to KVK Warrant liability		—

Net income attributable to shares of common stock, diluted	$	1,909

Weighted average number of shares of common stock outstanding		1,883
Dilutive effect of Deerfield Warrant		—
Dilutive effect of Series A Preferred		70
Dilutive effect of Series B-1 Preferred		27

Weighted average number of shares of common stock outstanding, diluted		1,980

Diluted net income per share of common stock	$	0.96

O.	Net Loss Per Share

Under the two-class method, for periods with net income, basic net income per share of common stock is computed by dividing the net income attributable to shares of common stock by the weighted average number of shares of common stock outstanding during the period. Net income attributable to shares of common stock is computed by subtracting from net income the portion of current period earnings that participating securities would have been entitled to receive pursuant to their dividend rights had all of the period’s earnings been distributed. No such adjustment to earnings is made during periods with a net loss as the holders of the participating securities have no obligation to fund losses. Diluted net income (loss) per share of common stock is computed under the two-class method by using the weighted average number of shares of common stock outstanding plus the potential dilutive effects of stock options and warrants. In addition, the Company analyzes the potential dilutive effect of the outstanding convertible securities under the if-converted method when calculating diluted income (loss) per share of common stock in which it is assumed that the outstanding convertible securities convert into common stock at the beginning of the period or date of issuance, if the convertible security was issued during the period. The Company reports the more dilutive of the approaches (two-class or if-converted) as its diluted net income (loss) per share of common stock during the period.

The following table summarizes the computation of basic and diluted net loss and net loss per share of common stock of the Company (in thousands, except share and per share amounts):


	Year Ended December 31,
	2019			2018
Net loss—basic and diluted	$	(24,522	)	$	(56,466	)

Weighted average number of shares of common stock—basic and diluted		1,853,348			1,120,626

Net loss per share—basic and diluted	$	(13.23	)	$	(50.39	)

Diluted net loss per share of common stock is the same as basic net loss per share of common stock for all periods presented because the effects of potentially dilutive items were anti-dilutive given the Company’s net loss. The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average number of shares of common stock outstanding because their effect is anti-dilutive:


	December 31,
	2019		2018
Deerfield Convertible Note		75,850		72,975
2021 Notes		10,958		280,072
2019 Notes*		1,851,609		—
Awards under equity incentive plans		324,473		231,493
Common stock warrants		151,442		157,957
Series A Convertible Preferred Stock		—		69,521

Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		2,414,332		812,018

*	Inclusive of 1,652,437 of shares of Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature.

Severance Expense

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Restructuring and Related Activities Disclosure [Text Block]

J.	Severance Expense

In February 2020, the Company eliminated the chief business officer role and Gordon K. Johnson separated from the Company. In connection with his separation, Mr. Johnson is entitled to severance benefits as documented in his Amended and Restated Employment Agreement entered into in June 2015. The severance benefits consist of personnel and other related charges of approximately $0.4 million and stock compensation expense of approximately $0.4 million related to the acceleration of vesting on unvested shares subject to certain stock options. These severance benefits are presented as severance expense in the unaudited condensed statements of operations for the nine months ended September 30, 2020. As of September 30, 2020, the Company had accrued severance expense recorded within accounts payable and accrued expenses in the amount of $0.1 million. As of September 30, 2019, there was no accrued severance. For the three months ended September 30, 2020 and three and nine months ended September 30, 2019 there was no severance expense.

P.	Severance Expense

On August 31, 2018, Daniel L. Cohen resigned from his position as the executive vice president, government and public relations of the Company, effective immediately. In connection with his resignation, Mr. Cohen and the Company entered into a separation and release agreement which included among other items, severance benefits. The severance benefits consisted of personnel and other related charges of approximately $0.4 million and stock compensation expense of approximately $1.2 million related to the acceleration of vesting on unvested shares subject to certain stock options and the extension of the exercise period for certain stock options. These severance benefits are presented as severance expense in the statement of operations for the fiscal year ended December 31, 2018. As of December 31, 2018, the Company had accrued severance expense recorded within accounts payable and accrued expenses in the amount of $0.2 million. No severance expense or accrued severance expense is recorded for the year ended or as of December 31, 2019.

On February 7, 2020, the Company eliminated the chief business officer role and Gordon K. Johnson was separated from the Company. As a result, the Company anticipates recognizing additional severance expense of approximately $1.0 million over the twelve months following the separation date, comprised of severance payments and non-cash stock-based compensation expense of approximately $0.4 million and $0.6 million, respectively

Leases

9 Months Ended

Sep. 30, 2020

Lease Disclosure [Text Block]

K.	Leases

The Company has operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. The Company’s leases have remaining lease terms of less than 1 year to approximately 5 years, some of which include options to extend the leases for up to 5 years, and some which include options to terminate the leases within 1 year. In February 2020, the Company agreed to sublease office space in Florida, comprised of one of the two contiguous suites, under a non-cancelable operating lease, which expires in February 2026. In October 2020, the Company agreed to terminate this sublease, in exchange for a termination payment, due to financial difficulties encountered by the subtenant as a result of COVID-19.

The components of lease expense were as follows (in thousands):


	Three months ended September 30,						Nine months ended September 30,
Lease Cost	2020			2019			2020			2019
Finance lease cost:
Amortization of right-of-use assets	$	31		$	31		$	92		$	92
Interest on lease liabilities		4			9			19			31

Total finance lease cost		35			40			111			123
Operating lease cost		91			124			272			372
Short-term lease cost		49			58			160			173
Variable lease cost		14			14			41			35
Less: sublease income		(40	)		(25	)		(93	)		(75	)

Total lease costs	$	149		$	211		$	491		$	628

Supplemental cash flow information related to leases was as follows (in thousands):


	Nine months ended September 30,
	2020		2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	19	$	31
Financing cash flows from finance leases		168		157
Operating cash flows from operating leases		334		326
Operating cash flows from short-term leases		160		173
Operating cash flows from variable lease costs		41		35

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	—	$	737
Operating leases		20		1,852

Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate):


	September 30, 2020			December 31, 2019
Finance Leases
Property and equipment, at cost	$	1,013		$	1,013
less: accumulated depreciation and amortization		(490	)		(398	)

Property and equipment, net	$	523		$	615

Other current liabilities	$	214		$	236
Other long-term liabilities		22			168

Total finance lease liabilities	$	236		$	404

Operating Leases
Operating lease right-of-use assets	$	1,357		$	1,537

Total operating lease right-of-use assets	$	1,357		$	1,537

Current portion of operating lease liabilities	$	318		$	284
Operating lease liabilities, less current portion		1,673			1,901

Total operating lease liabilities	$	1,991		$	2,185

Weighted Average Remaining Lease Term
Finance leases (years)		1			2
Operating leases (years)		5			6
Weighted Average Discount Rate
Finance leases		7.8	%		7.7	%
Operating leases		7.5	%		7.5	%

Maturities of lease liabilities were as follows (in thousands):


	Finance Leases			Operating Leases
Year Ending December 31,
2020 (excluding the nine months ended September 30, 2020)	$	73		$	114
2021		163			460
2022		11			463
2023		—			472
2024		—			484
Thereafter		—			420

Total lease payments		247			2,413
Less: future interest expense		(11	)		(422	)

Lease liabilities	$	236		$	1,991

Employee Benefit Plan

12 Months Ended

Dec. 31, 2019

Compensation and Employee Benefit Plans [Text Block]

Q.	Employee Benefit Plan

The Company has a 401(k) retirement plan (the “401(k) Plan”) that covers substantially all employees. The Company may provide a discretionary match with a maximum amount of 4% of the participant’s compensation, which vests immediately. The Company made matching contributions under the 401(k) Plan of $133,000 and $212,000 for the years ended December 31, 2019 and 2018, respectively.

The Company has a discretionary profit sharing plan (the “Profit Sharing Plan”) that covers all employees. Employees become eligible participants in the Profit Sharing Plan once they have provided three years of service to the Company. The Company made no contributions to the Profit Sharing Plan in 2019 or 2018.

Subsequent Events

9 Months Ended

Sep. 30, 2020

Subsequent Events [Abstract]

Subsequent Events [Text Block]

K.	Subsequent Events

In December 2020, the Company entered into a December 2020 Exchange Agreement and Amendment to Facility Agreement, Notes and Investors’ Rights Agreement, as amended (the “December 2020 Exchange Agreement”) with the Deerfield Lenders, DSC and Kingdon (collectively, the “Facility Agreement Note Holders”). Under the December 2020 Exchange Agreement, the Company and the Facility Agreement Note Holders have agreed that (a) upon closing of this offering the Company will make a cash pre-payment of a portion of principal amount of the Deerfield Convertible Note, the December 2019 Notes and the January 2020 Note (collectively, the “Facility Agreement Notes”) to the Facility Agreement Note Holders (the “Debt Payment”) equal to approximately $30.3 million, plus accrued interest if such payment is made on or after January 1, 2021, and (b) subject to the satisfaction or waiver of certain conditions specified in the December 2020 Exchange Agreement, including the making of the Debt Payment, issue shares of its Series B-2 Preferred Stock and warrants exercisable for shares of its common stock (the “Exchange Warrants”), in exchange for the cancellation of a portion of the principal amount of the Facility Agreement Notes owned by the Facility Agreement Note Holders in an aggregate amount equal to the Debt Payment, plus the Q4 PIK Interest Payment (as defined in the December 2020 Exchange Agreement) (such transaction, the “December 2020 Exchange”).

The December 2020 Exchange Agreement amends the Facility Agreement Notes to provide that the failure of the Company’s common stock to remain listed on an eligible securities market will not constitute a “Major Transaction” unless such failure occurs after March 31, 2023.

Subject to the satisfaction or waiver of certain conditions specified in the December 2020 Exchange Agreement, including the making of the Debt Payment and the consummation of the exchange, the December 2020 Exchange Agreement will amend that certain Facility Agreement dated as of June 2, 2014, as amended (the “Facility Agreement”), by and among the Company and the Facility Agreement Note Holders in order to, among other things, (i) extend the maturity date of the Facility Agreement Notes to March 31, 2023, (ii) provide for cash payments of interest on the Loans (as defined in the Facility Agreement) for the periods following July 1, 2021, and (iii) provide for specified prepayment terms on the Loans.

The December 2020 Exchange Agreement amends that certain Amended and Restated Investors’ Rights Agreement, dated as of February 19, 2015 (the “IRA”), by and among the Company, Deerfield and the other parties signatory thereto in order to, among other things, add Deerfield Special Situations Fund, L.P. as a party thereto and to give effect to the issuance of the Exchange Warrants and the Company’s registration obligations under the December 2020 Exchange Agreement (as described in more detail below).

The Exchange Warrants to be issued pursuant to the December 2020 Exchange Agreement will be exercisable for a number of shares of the Company’s common stock equal to 75% of the shares of common stock issuable upon conversion of the Series B-2 Preferred Stock issued in the Exchange (without regard for any beneficial ownership limitations included therein). The Exercise Warrants will be subject to substantially the same terms and conditions as the warrants issued to the public in the public offering of the Company’s securities contemplated pursuant to a registration statement on Form S-1, file no. 333-250945 (the “public Offering”), with an exercise price equal to the exercise price per share of the warrants issued in the Public Offering and will provide that the Facility Agreement Note Holders will be limited from exercising such Exchange Warrants if, as a result of such exercise, such holders (together with certain affiliates and “group” members of such holders) would beneficially own more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding.

The December 2020 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Facility Agreement Note Holders party thereto, including a covenant of the Company for the benefit of the Facility Agreement Holders party to the Exchange Agreement to file a registration statement to register for resale under the Securities Act the shares of common stock issuable upon exercise of the Exchange Warrants or conversion of the shares of Series B-2 Preferred Stock issued pursuant to the terms of the December 2020 Exchange Agreement.

The transactions contemplated under the December 2020 Exchange Agreement, including the obligation to pre-pay any portion of the Facility Agreement Notes or to complete the Exchange and the effectiveness of the amendments to the Facility Agreement, the Notes and the IRA, are subject to specified conditions of closing, including certain closing of the Public Offering, the filing of the Restated Series B-2 Certificate of Designation (as defined below) and the approval for listing of the Company’s common stock, including the shares issuable upon conversion of the Series B-2 Preferred Stock and exercise of the Exchange Warrants, on the Nasdaq Capital Market.

As a condition to closing of the December 2020 Exchange Agreement, the Company has agreed to file an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B-2 Convertible Preferred Stock (the “Restated Series B-2 Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series B-2 preferred Stock.

Each share of Series B-2 preferred Stock will have an aggregate stated value of $1,000 and will be convertible into shares of the Company’s common stock at a per share price equal to the price per share to the public of the Company’s common stock in the Public Offering (subject to adjustment to reflect stock splits and similar events).

The Series B-2 Preferred Stock will be convertible at any time on or after the PDUFA Date (as defined in the Restated Series B-2 Certificate of Designation) at the option of the holders thereof; provided that the holders thereof will be prohibited from converting shares of Series B-2 Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, such holders (together with certain affiliates and “group” members of such Holders) would beneficially own more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding. The Series B-2 Preferred Stock will not be redeemable. In the event of the Company’s liquidation, dissolution or winding up or a change in control of the Company (each, a “Liquidation Event”), the holders of Series B-2 Preferred Stock will receive, prior to any distribution or payment on our common stock, an amount equal to the greater of (i) $1,000 per share (in the case of a change in control, transaction consideration with such value), or (ii) the amount (in the case of a change in control, in the form of the transaction consideration) per share each such holder would have been entitled to receive if every share of Series B-2 Preferred Stock had been converted into common stock immediately prior to such Liquidation Event, in each case, plus any declared but unpaid dividends thereon. With respect to rights upon liquidation, the Series B-2 Preferred Stock will rank senior to the common stock, on parity with any Parity Securities (as defined in the Restated Series B-2 Certificate of Designation) and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that adversely affect the holders of Series B-2 Preferred Stock and other specified matters regarding the rights, preferences and privileges of the Series B-2 Preferred Stock), the Series B-2 Preferred Stock will not have voting rights. The Series B-2 Preferred Stock will not be subject to any price-based anti-dilution protections and will not provide for any accruing dividends, but provides that holders of Series B-2 Preferred Stock will participate in any dividends on the Company’s common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Restated Series B-2 Certificate of Designation will also provide for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-2 preferred Stock into common stock in accordance with the Restated Series B-2 Certificate of Designation.

Significant Accounting Policies (Policies)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Accounting Policies [Abstract]

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

Reclassification, Policy [Policy Text Block]

Reclassifications

Concentration Risk, Credit Risk, Policy [Policy Text Block]

Concentration of Credit Risk

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents

The Company considers any highly liquid investments with an original maturity of three months or less to be cash equivalents.

Marketable Securities, Policy [Policy Text Block]

Marketable Securities and Long-term Investments

Property, Plant and Equipment, Policy [Policy Text Block]

Property and Equipment

Debt, Policy [Policy Text Block]

Debt Issuance Costs

Collaborative Arrangement, Accounting Policy [Policy Text Block]

Supply Arrangements

Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]

Impairment of Long-Lived Assets

Fair Value of Financial Instruments, Policy [Policy Text Block]

Fair Value of Financial Instruments

•

Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;

•

Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and

•

Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

Revenue from Contract with Customer [Policy Text Block]

Revenue Recognition

Arrangements with Multiple-Performance Obligations

Licensing Agreements

The Company enters into licensing agreements with licensees that fall under the scope of ASC 606.

KP415 License Agreement

Consulting Arrangements

Corium Consulting Agreement

Other Consulting Arrangements

Revenue Recognition

Arrangements with Multiple-Performance Obligations

Licensing Agreements

The Company enters into licensing agreements with licensees that fall under the scope of ASC 606.

KP415 License Agreement

In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront payment of $10.0 million. The Company is also entitled to additional payments from Commave of up to $63.0 million, conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484. In addition, the Company is entitled to payments from Commave of up to $420.0 million in the aggregate, conditioned upon the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement

The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company has identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, as its only two performance obligations. The Company further determined that the transaction price under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the KP415 License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price.

The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket third-party research and development costs, was the fair value of the Development Costs (as defined in the KP415 License Agreement), which reflects the standalone selling price. The Company utilized a blended approach which took into consideration the adjusted market assessment approach and the expected cost plus a margin approach to determine this standalone selling price. This blended approach utilized the adjusted market approach and expected cost plus margin approach to value the performance of consulting services which included analyzing hourly rates of vendors in the a market who perform similar services to those of the Company to develop a range and then analyzing the average cost per hour of our internal resources and applying a margin which placed the value in the median of the previously identified range. For the reimbursement of out-of-pocket third-party research and development costs the Company utilized the expected cost plus a margin approach, which included estimating the actual out-of-pocket cost the Company expects to pay to third-parties for research and development costs and applying a margin, if necessary. The Company determined that no margin was necessary of these out-of-pocket third-party research and development costs as these are purely pass-through costs and the margin for managing these third-party activities is included within the value of the performance of consulting services. The Company determined that the performance of consulting services, including reimbursement of out-of-pocket third-party research and development costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable out-of-pocket third-party research and development costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As discussed above, the combination of the standalone selling price of these consulting services and certain out-of-pocket third-party research and development costs for KP415 was the fair value of the Development Costs at inception. These Development Costs effectively created a cap on certain consulting services and out-of-pocket third-party research and development costs identified in the initial product development plan for KP415 which was anticipated at the inception date of the KP415 License Agreement. As of December 31, 2019, the Company has recognized approximately 66% of the consulting services and out-of-pocket third-party research and development costs under this cap.

The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415 License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal.

Receivable [Policy Text Block]

Accounts and Other Receivables

Accounts and Other Receivables

Research and Development Expense, Policy [Policy Text Block]

Research and Development

Intangible Assets, Finite-Lived, Policy [Policy Text Block]

Patent Costs

Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations.

Income Tax, Policy [Policy Text Block]

Income Taxes

Share-based Payment Arrangement [Policy Text Block]

Stock-Based Compensation

Earnings Per Share, Policy [Policy Text Block]

Basic and Diluted Net Loss per Share of Common Stock

Segment Reporting, Policy [Policy Text Block]

Segment and Geographic Information

New Accounting Pronouncements, Policy [Policy Text Block]

Application of New or Revised Accounting Standards—Adopted

Application of New or Revised Accounting Standards—Not Yet Adopted

Application of New or Revised Accounting Standards—Adopted

Application of New or Revised Accounting Standards—Not Yet Adopted

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the FASB Concepts Statement, Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, which the FASB finalized on August 28, 2018, including the consideration of costs and benefits. This update applies to all entities that are required, under existing GAAP, to make disclosures about recurring or nonrecurring fair value measurements. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. An entity is permitted to early adopt any removed or modified disclosures and delay adoption of the additional disclosures until their effective date. The Company does not expect the adoption of ASU 2018-13 to have a material impact on the Company’s financial statements and disclosures.

Accounts and Other Receivables (Tables)

12 Months Ended

Dec. 31, 2019

Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block]


	December 31,
	2019		2018
Accounts receivable	$	1,681	$	—
Other receivables		184		140

Total accounts and other receivables	$	1,865	$	140

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2019

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block]


	December 31,
	2019		2018
Prepaid insurance	$	250	$	224
Deferred direct contract acquisition costs		805		—
Prepaid offering costs		266		—
Other prepaid expenses and current assets		231		1,688

Total prepaid expenses and other current assets	$	1,552	$	1,912

Accounts Payable and Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2019

Schedule of Accounts Payable and Accrued Liabilities [Table Text Block]


	December 31,
	2019		2018
Accrued interest	$	359	$	1,921
Accrued banking fees		700		700
Accrued severance		—		193
Accrued payroll		1		731
Accrued professional fees		2,364		230
Accounts payable		1,140		3,715
Other accrued expenses		347		852

Total accounts payable and accrued expenses	$	4,911	$	8,342

Debt Obligations (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Convertible Debt [Table Text Block]


	September 30, 2020			December 31, 2019
Deerfield Convertible Note	$	7,340		$	6,981
2021 Notes		—			3,000
December 2019 Notes		56,615			70,218
January 2020 Note		3,133			—

Total outstanding principal on debt obligations		67,088			80,199
Less: debt issuance costs and discounts		(1,168	)		(2,856	)

Convertible notes, net	$	65,920		$	77,343


	December 31,
	2019			2018
Deerfield Convertible Note	$	6,981		$	6,667
2021 Notes		3,000			76,673
December 2019 Notes		70,218			—

Total outstanding principal on debt obligations		80,199			83,340

Less: debt issuance costs and discounts		(2,856	)		(1,902	)

Convertible notes, net	$	77,343		$	81,438

Schedule of Maturities of Long-term Debt [Table Text Block]


Year Ending December 31,	Convertible Notes
2020	$	—
2021		80,199

Total minimum principal payments		80,199

Less: debt issuance costs and discounts		(2,856	)

Convertible notes, net	$	77,343

Commitments and Contingencies (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Lease, Cost [Table Text Block]


	Three months ended September 30,						Nine months ended September 30,
Lease Cost	2020			2019			2020			2019
Finance lease cost:
Amortization of right-of-use assets	$	31		$	31		$	92		$	92
Interest on lease liabilities		4			9			19			31

Total finance lease cost		35			40			111			123
Operating lease cost		91			124			272			372
Short-term lease cost		49			58			160			173
Variable lease cost		14			14			41			35
Less: sublease income		(40	)		(25	)		(93	)		(75	)

Total lease costs	$	149		$	211		$	491		$	628


Lease Cost	Year Ended December 31, 2019
Finance lease cost:
Amortization of right-of-use assets	$	123
Interest on lease liabilities		40

Total finance lease cost		163
Operating lease cost		473
Short-term lease cost		232
Variable lease cost		48
Less: sublease income		(84	)

Total lease costs	$	832

Schedule of Leases Cash Flow Information [Table Text Block]


	Nine months ended September 30,
	2020		2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	19	$	31
Financing cash flows from finance leases		168		157
Operating cash flows from operating leases		334		326
Operating cash flows from short-term leases		160		173
Operating cash flows from variable lease costs		41		35

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	—	$	737
Operating leases		20		1,852


	Year Ended December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	40
Financing cash flows from finance leases		207
Operating cash flows from operating leases		435
Operating cash flows from short-term leases		232
Operating cash flows from variable lease costs		48

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	757
Operating leases		1,852

Schedule of Leases Balance Sheet Information [Table Text Block]


	September 30, 2020			December 31, 2019
Finance Leases
Property and equipment, at cost	$	1,013		$	1,013
less: accumulated depreciation and amortization		(490	)		(398	)

Property and equipment, net	$	523		$	615

Other current liabilities	$	214		$	236
Other long-term liabilities		22			168

Total finance lease liabilities	$	236		$	404

Operating Leases
Operating lease right-of-use assets	$	1,357		$	1,537

Total operating lease right-of-use assets	$	1,357		$	1,537

Current portion of operating lease liabilities	$	318		$	284
Operating lease liabilities, less current portion		1,673			1,901

Total operating lease liabilities	$	1,991		$	2,185

Weighted Average Remaining Lease Term
Finance leases (years)		1			2
Operating leases (years)		5			6
Weighted Average Discount Rate
Finance leases		7.8	%		7.7	%
Operating leases		7.5	%		7.5	%


	December 31, 2019
Finance Leases
Property and equipment, at cost	$	1,013
less: accumulated depreciation and amortization		(398	)

Property and equipment, net	$	615

Other current liabilities	$	236
Other long-term liabilities		168

Total finance lease liabilities	$	404


Operating Leases
Operating lease right-of-use assets	$	1,537

Total operating lease right-of-use assets		1,537
Current portion of operating lease liabilities		284
Operating lease liabilities, less current portion		1,901

Total operating lease liabilities	$	2,185


Weighted Average Remaining Lease Term
Finance leases		2 years
Operating leases		6 years

Weighted Average Discount Rate
Finance leases		7.7	%
Operating leases		7.5	%

Operating and Finance Lease, Liability, Maturity [Table Text Block]


	Finance Leases			Operating Leases
Year Ending December 31,
2020 (excluding the nine months ended September 30, 2020)	$	73		$	114
2021		163			460
2022		11			463
2023		—			472
2024		—			484
Thereafter		—			420

Total lease payments		247			2,413
Less: future interest expense		(11	)		(422	)

Lease liabilities	$	236		$	1,991


Year Ending December 31,	Finance Leases			Operating Leases
2020	$	260		$	438
2021		163			449
2022		11			461
2023		—			472
2024		—			484
Thereafter		—			420

Total lease payments		434			2,724
Less: future interest expense		(30	)		(539	)

Lease liabilities	$	404		$	2,185

Common Stock and Warrants (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block]


	September 30, 2020		December 31, 2019
Conversion of Deerfield Convertible Note		79,748		75,850
Conversion of 2021 Notes		—		10,958
Conversion of January 2020 Note		34,037		—
Conversion of December 2019 Notes not subject to the Deerfield Optional Conversion Feature		615,307		199,172
Outstanding awards under equity incentive plans		354,379		324,473
Outstanding common stock warrants		151,442		151,442
In exchange for the Deerfield Optional Conversion Feature*		—		1,652,437
Possible future issuances under the equity line of credit		—		597,065
Possible future issuances under equity incentive plans		50,273		5,325

Total common shares reserved for future issuance		1,285,186		3,016,722

*	Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature


	December 31,
	2019		2018
Conversion of Deerfield Convertible Note		75,850		72,975
Conversion of 2021 Notes		10,958		280,072
Conversion of 2019 Notes not subject to the Deerfield Optional Conversion Feature		199,172		—
Outstanding awards under equity incentive plans		324,473		231,493
Outstanding common stock warrants		151,442		157,957
Conversion of Series A Preferred Stock		—		69,521
In exchange for the Deerfield Optional Conversion Feature*		1,652,437		—
Possible future issuances under the Prior Purchase Agreement		597,065		—
Possible future issuances under equity incentive plans		5,325		40,557

Total common shares reserved for future issuance		3,016,722		852,575

Schedule of Common Stock Outstanding Roll Forward [Table Text Block]


	Shares of Common Stock
Balance as of December 31, 2019		2,271,833
Common stock issued under equity line of credit		269,289
Restricted stock vested during the period		3,806
Common stock issued as compensation to third-parties		2,484
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		1,000,000

Balance as of March 31, 2020		3,547,412

Common stock issued under equity line of credit		309,971
Restricted stock vested during the period		4,015
Common stock issued as compensation to third-parties		11,873
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		328,125

Balance as of June 30, 2020		4,201,396

Restricted stock vested during the period		1,384
Common stock issued as compensation to third-parties		4,668
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		324,312
Common stock issued as a result of stock option exercise		279

Balance as of September 30, 2020		4,532,039


	Shares of Common Stock
Balance as of January 1, 2018		916,021

Common stock sold under First ATM Agreement		47,638
Common stock issued as a result of Deerfield Convertible Note principal and interest conversion		37,410
Common stock options exercised		1,476
Common stock sold under underwritten public offering		520,833
Common stock issued as a result of Series A Preferred Stock conversion		129,998

Balance as of December 31, 2018		1,653,376

Common stock issued under the Prior Purchase Agreement		220,091
Restricted stock vested during the period		6,354
Common stock issued as a result of 2021 Notes principal conversion		93,742
Common stock issued as a result of Series B-1 Preferred Stock conversion		103,749
Common stock issued as a result of Series A Preferred Stock conversion		69,521
Common stock issued as a result of Deerfield Optional Conversion Feature conversion		125,000

Balance as of December 31, 2019		2,271,833

Stock-based Compensation (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]


	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019
Research and development	$	157	$	400	$	748	$	1,196
General and administrative		228		657		866		2,468
Severance expense		—		—		420		—

Total stock-based compensation expense	$	385	$	1,057	$	2,034	$	3,664


	Year ended December 31,
	2019		2018
Research and development	$	1,459	$	1,608
General and administrative		2,951		3,651
Severance expense		—		1,236

Total stock-based compensation expense	$	4,410	$	6,495

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]


	Year Ended December 31,
	2019	2018
Risk-free interest rate	1.75% - 2.61%	2.43% - 2.91%
Expected term (in years)	5.50 - 10.00	5.50 - 6.79
Expected volatility	84.82% - 85.93%	83.10% - 85.05%
Expected dividend yield	0%	0%

Share-based Payment Arrangement, Option, Activity [Table Text Block]


	Number of Options			Weighted Average Exercise Price		Weighted Avg Remaining Contractual Term (years)		Aggregate Intrinsic Value
Outstanding balance at January 1, 2019		231,477		$	149.62		7.48	$	—
Granted		143,223		$	29.30
Exercised or released		(6,354	)	$	—
Canceled or forfeited		(42,209	)	$	140.81
Expired		(1,664	)	$	76.80

Outstanding balance at December 31, 2019		324,473		$	100.96		7.63	$	—

Exercisable at December 31, 2019		134,614		$	172.84		6.04	$	—

Vested and expected to vest at December 31, 2019		281,356		$	114.56		7.30	$	—

Share-based Payment Arrangement, Option, Exercise Price Range [Table Text Block]


	Options Outstanding				Options Exercisable
Exercise Price	Number of Shares		Weighted Avg Remaining Contractual Term		Number of Shares		Weighted Avg Remaining Contractual Term
$8.2576 to $80.00		181,415		8.72		29,920		7.19
$80.01 to $160.00		68,914		6.74		37,478		5.62
$160.01 to $240.00		29,489		5.94		23,821		5.90
$240.01 to $320.00		23,719		5.70		22,459		5.67
$320.01 to $327.20		20,936		5.68		20,936		5.68

		324,473		7.63		134,614		6.04

Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]


	Number of Unvested Shares
	December 31,
Exercise Price	2019		2018
$8.2576 to $80.00		151,495		39,646
$80.01 to $160.00		31,436		51,165
$160.01 to $240.00		5,668		11,659
$240.01 to $320.00		1,260		8,740
$320.01 to $327.20		—		5,432

Total number of unvested stock options		189,859		116,642

Fair Value of Financial Instruments (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]


	Balance as of September 30, 2020		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	134	$	—	$	—	$	134
Embedded Warrant Put Option		19		—		—		19
Deerfield Note Put Option		—		—		—		—
KVK Warrant liability		31		—		31		—

Total liabilities	$	184	$	—	$	31	$	153


	Balance as of December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	77	$	—	$	—	$	77
Embedded Warrant Put Option		19		—		—		19
Deerfield Note Put Option		—		—		—		—
Fundamental change and make-whole interest provisions embedded within 2021 Notes		—		—		—		—
KVK Warrant liability		24		—		24		—

Total liabilities	$	120	$	—	$	24	$	96


	Balance at December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	77	$	—	$	—	$	77
Embedded Warrant Put Option		19		—		—		19
Fundamental change and make-whole interest provisions embedded within 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		—		—		—		—
KVK Warrant liability		24		—		24		—

Total liabilities	$	120	$	—	$	24	$	96


	Balance at December 31, 2018		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	1,557	$	—	$	—	$	1,557
Embedded Warrant Put Option		154		—		—		154
Fundamental change and make-whole interest provisions embedded within 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		134		—		—		134
KVK Warrant liability		273		—		273		—

Total liabilities	$	2,118	$	—	$	273	$	1,845


Trading securities:
Certificates of deposit	$	246	$	246	$	—	$	—
U.S. Treasury securities		3,014		3,014		—		—

Total assets	$	3,260	$	3,260	$	—	$	—

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]


	Three months ended September 30,					Nine months ended September 30,
	2020		2019			2020		2019
Balance as of beginning of period	$	38	$	1,437		$	96	$	1,845
Adjustment to fair value		115		(1,168	)		57		(1,576	)

Balance as of end of period	$	153	$	269		$	153	$	269


	2019			2018
Balance as of beginning of period	$	1,845		$	7,709
Gain on extinguishment of debt		—			(2	)
Adjustment to fair value		(1,749	)		(5,862	)

Balance as of end of period	$	96		$	1,845

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2019

Schedule of Effective Income Tax Rate Reconciliation [Table Text Block]


	Year ended December 31,
	2019			2018
Federal statutory rate		21.00			21.00
Effect of:
Change in valuation allowance		(28.52	)		(30.44	)
Return to provision and deferred true-up		—			0.38
Change in rate		(0.33	)		0.03
State tax benefit (net of federal)		3.39			4.35
Warrant liability		1.71			2.02
State research and development credit		0.09			0.22
Federal research and development credit		1.44			3.30
Amortization		(0.29	)		—
Stock-based compensation		(1.10	)		(0.63	)
Other		2.70			(0.01	)

Federal income tax provision effective rate		0.09			0.22

Schedule of Deferred Tax Assets and Liabilities [Table Text Block]


	December 31,
	2019			2018
Deferred tax assets relating to:
Net operating loss carryforwards	$	56,827		$	51,269
Research and development tax carryforward		6,411			5,657
Other deferred tax assets		4,488			3,437

Total gross deferred tax assets		67,726			60,363

Deferred tax liabilities relating to:
Property and equipment		—			161
Other deferred tax liabilities		540			10

Total gross deferred tax liabilities		540			171

Deferred tax assets less liabilities		67,186			60,192
Valuation allowance		(67,186	)		(60,192	)

Net deferred tax asset (liability)	$	—		$	—

Summary of Operating Loss Carryforwards [Table Text Block]


Year Incurred	Net Operating Loss CF		Research Activities Cr.		Expiration
2007	$	454	$	30		2027
2008		1,178		65		2028
2009		3,060		176		2029
2010		3,423		149		2030
2011		9,929		176		2031
2012		—		170		2032
2013		4,353		133		2033
2014		15,897		894		2034
2015		23,496		598		2035
2016		41,580		745		2036
2017		34,776		652		2037
2018		56,155		2,272		Indefinite
2019		22,784		352		Indefinite

	$	217,085	$	6,412

Leases (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Lease, Cost [Table Text Block]


	Three months ended September 30,						Nine months ended September 30,
Lease Cost	2020			2019			2020			2019
Finance lease cost:
Amortization of right-of-use assets	$	31		$	31		$	92		$	92
Interest on lease liabilities		4			9			19			31

Total finance lease cost		35			40			111			123
Operating lease cost		91			124			272			372
Short-term lease cost		49			58			160			173
Variable lease cost		14			14			41			35
Less: sublease income		(40	)		(25	)		(93	)		(75	)

Total lease costs	$	149		$	211		$	491		$	628


Lease Cost	Year Ended December 31, 2019
Finance lease cost:
Amortization of right-of-use assets	$	123
Interest on lease liabilities		40

Total finance lease cost		163
Operating lease cost		473
Short-term lease cost		232
Variable lease cost		48
Less: sublease income		(84	)

Total lease costs	$	832

Schedule of Leases Cash Flow Information [Table Text Block]


	Nine months ended September 30,
	2020		2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	19	$	31
Financing cash flows from finance leases		168		157
Operating cash flows from operating leases		334		326
Operating cash flows from short-term leases		160		173
Operating cash flows from variable lease costs		41		35

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	—	$	737
Operating leases		20		1,852


	Year Ended December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	40
Financing cash flows from finance leases		207
Operating cash flows from operating leases		435
Operating cash flows from short-term leases		232
Operating cash flows from variable lease costs		48

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	757
Operating leases		1,852

Schedule of Leases Balance Sheet Information [Table Text Block]


	September 30, 2020			December 31, 2019
Finance Leases
Property and equipment, at cost	$	1,013		$	1,013
less: accumulated depreciation and amortization		(490	)		(398	)

Property and equipment, net	$	523		$	615

Other current liabilities	$	214		$	236
Other long-term liabilities		22			168

Total finance lease liabilities	$	236		$	404

Operating Leases
Operating lease right-of-use assets	$	1,357		$	1,537

Total operating lease right-of-use assets	$	1,357		$	1,537

Current portion of operating lease liabilities	$	318		$	284
Operating lease liabilities, less current portion		1,673			1,901

Total operating lease liabilities	$	1,991		$	2,185

Weighted Average Remaining Lease Term
Finance leases (years)		1			2
Operating leases (years)		5			6
Weighted Average Discount Rate
Finance leases		7.8	%		7.7	%
Operating leases		7.5	%		7.5	%


	December 31, 2019
Finance Leases
Property and equipment, at cost	$	1,013
less: accumulated depreciation and amortization		(398	)

Property and equipment, net	$	615

Other current liabilities	$	236
Other long-term liabilities		168

Total finance lease liabilities	$	404


Operating Leases
Operating lease right-of-use assets	$	1,537

Total operating lease right-of-use assets		1,537
Current portion of operating lease liabilities		284
Operating lease liabilities, less current portion		1,901

Total operating lease liabilities	$	2,185


Weighted Average Remaining Lease Term
Finance leases		2 years
Operating leases		6 years

Weighted Average Discount Rate
Finance leases		7.7	%
Operating leases		7.5	%

Operating and Finance Lease, Liability, Maturity [Table Text Block]


	Finance Leases			Operating Leases
Year Ending December 31,
2020 (excluding the nine months ended September 30, 2020)	$	73		$	114
2021		163			460
2022		11			463
2023		—			472
2024		—			484
Thereafter		—			420

Total lease payments		247			2,413
Less: future interest expense		(11	)		(422	)

Lease liabilities	$	236		$	1,991


Year Ending December 31,	Finance Leases			Operating Leases
2020	$	260		$	438
2021		163			449
2022		11			461
2023		—			472
2024		—			484
Thereafter		—			420

Total lease payments		434			2,724
Less: future interest expense		(30	)		(539	)

Lease liabilities	$	404		$	2,185

Net (Loss) Income Per Share (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2020

Dec. 31, 2019

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]


	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019
Deerfield Convertible Note		79,748		74,557		79,748		74,557
2021 Notes*		—		1,947,924		—		1,947,924
January 2020 Note		34,037		—		34,037		—
December 2019 Notes		615,307		—		615,307		—
Awards under equity incentive plans		354,379		288,770		354,379		288,770
Common stock warrants		151,442		31,250		151,442		151,442
Series A Convertible Preferred Stock		—		—		—		69,521
Series B-1 Convertible Preferred Stock		—		—		—		51,941

Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		1,234,913		2,342,501		1,234,913		2,584,155

*	Inclusive of 1,777,437 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount.


	December 31,
	2019		2018
Deerfield Convertible Note		75,850		72,975
2021 Notes		10,958		280,072
2019 Notes*		1,851,609		—
Awards under equity incentive plans		324,473		231,493
Common stock warrants		151,442		157,957
Series A Convertible Preferred Stock		—		69,521

Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		2,414,332		812,018

*	Inclusive of 1,652,437 of shares of Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature.

Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]


	Three months ended September 30, 2019
Basic net income per share of common stock:
Net income	$	3,063
Less: Net income attributable to participating securities		(348	)

Net income attributable to shares of common stock		2,715
Less: Dividends declared or accumulated		—

Undistributed net income attributable to shares of common stock, basic	$	2,715

Weighted average number of shares of common stock outstanding		1,883

Basic net income per share of common stock	$	1.44

Diluted net income per share of common stock:
Net income	$	3,063
Less: Fair value adjustment income related to Deerfield Warrant liability		(1,019	)
Less: Fair value adjustment income related to embedded Warrant Put Option		(135	)
Less: Fair value adjustment income related to KVK Warrant liability		—

Net income attributable to shares of common stock, diluted	$	1,909

Weighted average number of shares of common stock outstanding		1,883
Dilutive effect of Deerfield Warrant		—
Dilutive effect of Series A Preferred		70
Dilutive effect of Series B-1 Preferred		27

Weighted average number of shares of common stock outstanding, diluted		1,980

Diluted net income per share of common stock	$	0.96


	Year Ended December 31,
	2019			2018
Net loss—basic and diluted	$	(24,522	)	$	(56,466	)

Weighted average number of shares of common stock—basic and diluted		1,853,348			1,120,626

Net loss per share—basic and diluted	$	(13.23	)	$	(50.39	)

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2019

Property, Plant and Equipment [Table Text Block]


	December 31,
	2019			2018
Laboratory equipment	$	638		$	1,035
Furniture and office equipment		119			655
Computers and hardware		303			299
Leasehold improvements		958			1,017
Finance lease right-of-use assets		1,013			—

Total property and equipment		3,031			3,006
Less: accumulated depreciation and amortization		(1,560	)		(1,253	)

Property and equipment, net	$	1,471		$	1,753

Property, Plant and Equipment, Useful Life [Table Text Block]


Asset Category		Useful Life (in years)
Laboratory equipment		10
Furniture and office equipment		5 - 10
Computers and hardware		3 - 7
Leasehold improvements		9

Description of Business and Basis of Presentation (Details Textual) - USD ($)						1 Months Ended			3 Months Ended		9 Months Ended		12 Months Ended			23 Months Ended
	Apr. 23, 2020	Sep. 03, 2019	Feb. 28, 2019	Oct. 10, 2018	Oct. 05, 2018	May 31, 2020	Feb. 29, 2020	Oct. 31, 2018	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Feb. 29, 2020	Dec. 31, 2019	Dec. 31, 2018	Sep. 04, 2018	Dec. 23, 2020	Oct. 31, 2019	Mar. 31, 2019
Common stock, par value (in dollars per share)									$ 0.0001		$ 0.0001			$ 0.0001	$ 0.0001
Sale of Securities, Value, Available to Issue														$ 150,000,000				$ 80,000,000
Sale of Securities, Value, Remaining Available to Issue														10,900,000
Sale of Securities Covered Under Prospectus Supplement, Value, Anticipated Sales Under Purchase Agreement														4,000,000	$ 5,700,000
Proceeds from Issuance of Common Stock															4,828,000
Revenue from Contract with Customer, Including Assessed Tax									$ 1,925,000	$ 11,463,000	$ 10,922,000	$ 11,463,000		12,839,000	$ 0
Proceeds from Issuance of Long-term Debt, Total											$ 781,000
Subsequent Event [Member]
Common stock, par value (in dollars per share)																	$ 0.0001
License [Member]
Revenue from Contract with Customer, Including Assessed Tax														$ 10,000,000
Cowen and Company, LLC [Member]
Stock Issued During Period, Shares, New Issues (in shares)																47,638
Proceeds from Issuance of Common Stock																$ 4,900,000
Sale of Stock, Commission Fee																3.00%
RBC Capital Markets, LLC [Member]
Sale of Stock, Authorized Offering Price																$ 50,000,000			$ 3,200,000
Lincoln Park [Member]
Sale of Securities, Value, Available to Issue			$ 15,000,000				$ 4,000,000						$ 4,000,000
Stock Issued During Period, Shares, New Issues (in shares)											559,971		212,579	212,579
Proceeds from Issuance of Common Stock											$ 2,300,000		$ 5,400,000	$ 5,400,000
Purchase Agreement, Term (Month)			3 years				1 year
Purchase Agreement, Additional Shares to Be Issued as Commitment Shares (in shares)			7,512			19,289	19,289				19,289
Purchase Agreement, Maximum Shares to be Issued (in shares)						579,260
Lincoln Park [Member] \| Subsequent Event [Member]
Sale of Securities, Value, Available to Issue							$ 4,000,000						$ 4,000,000
Purchase Agreement, Term (Month)							1 year
Purchase Agreement, Additional Shares to Be Issued as Commitment Shares (in shares)							19,289
KVK [Member]
License Agreement, Estimated Pre-launch Payments and Costs Reimbursements								$ 3,400,000
License Agreement, Pre-launch Payment Reimbursement Within 10 Days of Initial Adoption Milestone								2,000,000
License Agreement, Maximum Payments Received for Sales Milestones								$ 53,000,000
KVK [Member] \| Maximum [Member]
License Agreement, Percentage of Net Sales on Rolling Four Quarter Basis Received								50.00%
KVK [Member] \| Minimum [Member]
License Agreement, Percentage of Net Sales on Rolling Four Quarter Basis Received								30.00%
GPC [Member] \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax		$ 10,000,000							$ 0	$ 11,500,000	$ 7,300,000	$ 1,000,000
Revenue Recognition, Milestone Method, Revenue to be Recognized		63,000,000
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized		$ 420,000,000
Royalty Revenue, Percent		10.00%
Regulatory Milestone Revenue to Be Earned Following FDA Acceptance		$ 5,000,000				$ 5,000,000
First ATM Agreement [Member]
Stock Issued During Period, Shares, New Issues (in shares)														212,579	47,638
Proceeds from Issuance of Common Stock														$ 5,400,000
Second ATM Agreement [Member]
Stock Issued During Period, Shares, New Issues (in shares)														0
Second ATM Agreement [Member] \| RBC Capital Markets, LLC [Member] \| Maximum [Member]
Sale of Stock, Authorized Offering Price																$ 50,000,000
Underwriting Agreement [Member] \| RBC Capital Markets, LLC [Member]
Stock Issued During Period, Shares, New Issues (in shares)				520,833	520,833
Shares Issued, Price Per Share				$ 48.00
Proceeds from Issuance of Common Stock, Net				$ 23,100,000
Paycheck Protection Program CARES Act [Member]
Proceeds from Issuance of Long-term Debt, Total	$ 800,000

Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands		3 Months Ended			9 Months Ended		12 Months Ended
	Sep. 03, 2019	Sep. 30, 2020	Jun. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018	Jul. 31, 2020	May 31, 2020	Jan. 01, 2019
Prepaid Expense and Other Assets, Current		$ 675			$ 675		$ 1,552	$ 1,912
Increase (Decrease) in Prepaid Expense and Other Assets, Total					(537)	$ (1,420)	(544)	548
Asset Impairment Charges, Total							0	0
Revenue from Contract with Customer, Including Assessed Tax		1,925		$ 11,463	10,922	11,463	12,839	0
Accounts Receivable, after Allowance for Credit Loss, Current, Total							1,681	0
Cost of Goods and Services Sold, Total							10,000	0
Capitalized Contract Cost, Gross							2,800
Deferred Revenue, Total							0	0
Accounts Receivable, Allowance for Credit Loss, Ending Balance		0			0		0	0
Income Tax Examination, Penalties and Interest Accrued, Total							$ 0	0
Open Tax Year							2014 2015 2016 2017 2018 2019
Lease liabilities, Operating leases		1,991			1,991		$ 2,185
Total operating lease right-of-use assets		1,357			1,357		1,537
Accounting Standards Update 2016-02 [Member]
Lease liabilities, Operating leases											$ 2,600
Total operating lease right-of-use assets											$ 2,600
Royalty and Direct Contract Acquisition Costs [Member]
Capitalized Contract Cost, Amortization							1,900
License [Member]
Revenue from Contract with Customer, Including Assessed Tax							10,000
Accounts Receivable, after Allowance for Credit Loss, Current, Total		0			0		1,600
Reimbursement of Out-of-pocket Third-party Research and Development Costs [Member]
Revenue from Contract with Customer, Including Assessed Tax							1,100
Accounts Receivable, after Allowance for Credit Loss, Current, Total							200
Consulting Services [Member]
Revenue from Contract with Customer, Including Assessed Tax		0		0	1,700	0	1,700
Accounts Receivable, after Allowance for Credit Loss, Current, Total		0			0		100
Deferred Revenue, Total		0			0		0
GPC [Member] \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax	$ 10,000	0		11,500	7,300	1,000
Revenue Recognition, Milestone Method, Revenue to be Recognized	63,000
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized	420,000
Capitalized Contract Cost, Gross		2,800			2,800
Deferred Revenue, Total		0			0		0
Regulatory Milestone Revenue to Be Earned Following FDA Acceptance	$ 5,000									$ 5,000
Contract with Customer, Liability, Revenue Recognized			$ 5,000
GPC [Member] \| License [Member] \| Royalty and Direct Contract Acquisition Costs [Member]
Capitalized Contract Cost, Amortization		0			800
Corium, Inc [Member] \| Consulting Services [Member]
Revenue from Contract with Customer, Including Assessed Tax		1,900		$ 0	1,900	$ 0
Accounts Receivable, after Allowance for Credit Loss, Current, Total		2,000			2,000
Deferred Revenue, Total		$ 100			$ 100		$ 0
Consulting Agreement, Maximum Amount to be Received									$ 15,600
Contract with Customer, Asset, after Allowance for Credit Loss, Total									13,600
Consulting Agreement, Conditional Milestone Achievement to be Received									$ 2,000
Percentage of Consulting Services and Out-of-pocket Third-party Research and Development Costs Recognized									15.00%
Minimum [Member]
Property, Plant and Equipment, Useful Life							3 years
Maximum [Member]
Property, Plant and Equipment, Useful Life							10 years
Scenario, Previously Reported [Member] \| Consulting Services [Member]
Accounts Receivable, after Allowance for Credit Loss, Current, Total							$ 1,400
Restatement Adjustment [Member]
Prepaid Expense and Other Assets, Current								(100)
Increase (Decrease) in Prepaid Expense and Other Assets, Total								$ (100)

Accounts and Other Receivables - Accounts and Other Receivables (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Accounts receivable		$ 1,681	$ 0
Other receivables		184	140
Total accounts and other receivables	$ 2,202	$ 1,865	$ 140

Prepaid Expenses and Other Current Assets - Components of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Prepaid insurance		$ 250	$ 224
Deferred direct contract acquisition costs		805
Prepaid offering costs		266
Other prepaid expenses and current assets		231	1,688
Total prepaid expenses and other current assets	$ 675	$ 1,552	$ 1,912

Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Property and equipment, gross		$ 3,031	$ 3,006
Less: accumulated depreciation and amortization		(1,560)	(1,253)
Property and equipment, net	$ 1,079	1,471	1,753
Laboratory Equipment [Member]
Property and equipment, gross		638	1,035
Furniture and Fixtures [Member]
Property and equipment, gross		119	655
Computer and Hardware [Member]
Property and equipment, gross		303	299
Leasehold Improvements [Member]
Property and equipment, gross		958	1,017
Finance Lease, Right-of-Use Assets [Member]
Property and equipment, gross		$ 1,013

Property and Equipment - Estimated Useful Lives of Property and Equipment (Details)	12 Months Ended
	Dec. 31, 2019
Minimum [Member]
Property and equipment, useful lives (Year)	3 years
Maximum [Member]
Property and equipment, useful lives (Year)	10 years
Laboratory Equipment [Member]
Property and equipment, useful lives (Year)	10 years
Furniture and Fixtures [Member] \| Minimum [Member]
Property and equipment, useful lives (Year)	5 years
Furniture and Fixtures [Member] \| Maximum [Member]
Property and equipment, useful lives (Year)	10 years
Computer and Hardware [Member] \| Minimum [Member]
Property and equipment, useful lives (Year)	3 years
Computer and Hardware [Member] \| Maximum [Member]
Property and equipment, useful lives (Year)	7 years
Leasehold Improvements [Member]
Property and equipment, useful lives (Year)	9 years

Property and Equipment (Details Textual) - USD ($)	9 Months Ended		12 Months Ended
Property and Equipment (Details Textual) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Depreciation, Depletion and Amortization, Total	$ 207,000	$ 229,000	$ 304,000	$ 324,000

Accounts Payable and Accrued Expenses - Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Accrued interest		$ 359	$ 1,921
Accrued banking fees		700	700
Accrued severance			193
Accrued payroll		1	731
Accrued professional fees		2,364	230
Accounts payable		1,140	3,715
Other accrued expenses		347	852
Total accounts payable and accrued expenses	$ 4,347	$ 4,911	$ 8,342

Debt Obligations - Convertible Notes Outstanding (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Convertible notes	$ 67,088	$ 80,199	$ 83,340
Less: debt issuance costs and discounts	(1,168)	(2,856)	(1,902)
Convertible notes, net	65,920	77,343	81,438
Deerfield Convertible Notes [Member]
Convertible notes	7,340	6,981	6,667
2021 Notes [Member]
Convertible notes		3,000	76,673
The 2019 Notes [Member]
Convertible notes	56,615	70,218
January 2020 Note [Member]
Convertible notes	$ 3,133

Debt Obligations - Future Minimum Payments (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
2020
2021		80,199
Total minimum principal payments	$ 67,088	80,199	$ 83,340
Less: debt issuance costs and discounts	(1,168)	(2,856)	(1,902)
Convertible notes, net	$ 65,920	$ 77,343	$ 81,438

Debt Obligations (Details Textual)												1 Months Ended		3 Months Ended			4 Months Ended	8 Months Ended	9 Months Ended		12 Months Ended		13 Months Ended	15 Months Ended	24 Months Ended
Debt Obligations (Details Textual)	Dec. 23, 2020 $ / shares shares	Jun. 05, 2020	Apr. 23, 2020 USD ($)	Jan. 13, 2020 USD ($) $ / shares	Dec. 31, 2019 USD ($) $ / shares shares	Dec. 18, 2019 USD ($) $ / shares shares	Sep. 03, 2019 USD ($) $ / shares shares	Oct. 05, 2018 USD ($) $ / shares shares	Jun. 11, 2018 USD ($) shares	Feb. 09, 2016 USD ($) $ / shares shares	Jun. 02, 2014 USD ($) $ / shares shares	Sep. 30, 2019 shares	Apr. 30, 2015 shares	Sep. 30, 2020 USD ($) $ / shares shares	Jun. 30, 2020 shares	Mar. 31, 2020 shares	Dec. 31, 2019 USD ($) $ / shares shares	Sep. 03, 2019 USD ($) $ / shares shares	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($) $ / shares shares	Dec. 31, 2018 USD ($) $ / shares shares	Sep. 30, 2020 USD ($) $ / shares shares	Dec. 31, 2019 USD ($) $ / shares shares	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 02, 2019	Oct. 31, 2018 shares	Jun. 30, 2016
Convertible Notes Payable, Current \| $														$ 65,920,000					$ 65,920,000			$ 3,333,000	$ 65,920,000		$ 65,920,000
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock							4.985%											4.985%
Change in Fair Value of Embedded Conversion Feature \| $																				$ 2,311,000
Interest Paid, Excluding Capitalized Interest, Operating Activities \| $																			71,000	4,602,000	$ 5,362,000	$ 5,539,000
Conversion of Stock, Maximum Shares Issued (in shares) \| shares						28,439,015
Proceeds from Issuance of Long-term Debt, Total \| $																			$ 781,000
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) \| shares																						37,410
Subsequent Event [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) \| shares	120,192
Common stock outstanding after reverse stock split ratio \| shares	16,025
Deerfield Warrant [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 93.60
Series A Preferred Stock Converted Into Common Stock [Member]
Conversion of Stock, Shares Issued (in shares) \| shares																					69,521	129,998		199,519
Conversion of Stock, Shares Converted (in shares) \| shares																								9,577	9,577
Conversion Of Stock Shares Issuable If Converted (in shares) \| shares																											3,192,333
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) \| shares																									199,519
Series A Preferred Stock Converted Into Common Stock [Member] \| Subsequent Event [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	48.00
Convertible Preferred Stock, Conversion Price (in dollars per share)	$ 48.00
Conversion of Stock, Maximum Shares Issued (in shares) \| shares	199,519
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member]
Conversion of Stock, Shares Issued (in shares) \| shares												1,659,996					103,749				103,749		103,749
Conversion of Stock, Shares Converted (in shares) \| shares																	1,576				1,576		1,576
Optional Exchange Principal Amount Conversion Feature [Member[
Conversion of Stock, Shares Issued (in shares) \| shares																					125,000
Series A Preferred Stock [Member]
Preferred Stock, Par or Stated Value Per Share (in dollars per share)								$ 0.0001
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)								1,000
Convertible Preferred Stock, Conversion Price (in dollars per share)								$ 3
Convertible Preferred Stock, Shares Issuable Upon Conversion (in shares) \| shares								3,192,333
Conversion Of Stock Shares Issuable If Converted (in shares) \| shares								3,192,333
Preferred Stock, Shares Outstanding, Ending Balance (in shares) \| shares					0									0			0		0		0	3,337	0	0	0
Series B-1 Convertible Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares							1,576
Conversion of Stock, Shares Issued (in shares) \| shares																					103,749
Preferred Stock, Par or Stated Value Per Share (in dollars per share)					$ 0.0001		$ 0.0001							$ 0.0001			$ 0.0001	$ 0.0001	$ 0.0001		$ 0.0001	$ 0.0001	$ 0.0001	$ 0.0001	$ 0.0001
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)							1,000											1,000
Convertible Preferred Stock, Conversion Price (in dollars per share)							$ 0.9494											$ 0.9494
Conversion Of Stock Shares Issuable If Converted (in shares) \| shares							1,659,996											1,659,996
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock							4.985%											4.985%
Preferred Stock, Liquidation Preference Per Share (in dollars per share)							$ 0.0001											$ 0.0001
Preferred Stock, Shares Outstanding, Ending Balance (in shares) \| shares					0									0			0		0		0	0	0	0	0
Series B-1 Convertible Preferred Stock [Member] \| Subsequent Event [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 15.1904
Convertible Preferred Stock, Conversion Price (in dollars per share)	$ 15.1904
Conversion of Stock, Maximum Shares Issued (in shares) \| shares	103,749
Series B-2 Convertible Preferred Stock [Member]
Preferred Stock, Par or Stated Value Per Share (in dollars per share)					$ 0.0001		0.0001							$ 0.0001			$ 0.0001	0.0001	$ 0.0001		$ 0.0001	$ 0.0001	$ 0.0001	$ 0.0001	$ 0.0001
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)							1,000											1,000
Convertible Preferred Stock, Conversion Price (in dollars per share)							$ 0.9494											$ 0.9494
Conversion Of Stock Shares Issuable If Converted (in shares) \| shares							28,439,015											28,439,015
Preferred Stock, Shares Outstanding, Ending Balance (in shares) \| shares					0									0			0		0		0	0	0	0	0
Series B-2 Convertible Preferred Stock [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 9.60
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 15.1904
Conversion of Stock, Maximum Shares Issued (in shares) \| shares	1,777,437
Debt instrument convertible exchange price trading days	15 days
Series B Preferred Stock [Member]
Preferred Stock, Liquidation Preference Per Share (in dollars per share)							$ 0.0001											$ 0.0001
Conversion from Deerfield Convertible Note to Common Stock [Member]
Debt Conversion, Original Debt, Amount \| $									$ 3,333,333
Debt Conversion, Accrued Interest \| $									$ 168,288
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares									37,410
Exchanged 2021 Notes for Series A Preferred Stock [Member]
Debt Conversion, Original Debt, Amount \| $								$ 9,577,000
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares								9,577
DebtConversionOptionToExchangeAmount \| $							$ 27,000,000											$ 27,000,000
2021 Notes Converted To Common Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares							93,742
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) \| shares																					93,742
2021 Notes Converted To Series B-1 Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares							1,576
Conversion From Deerfield Convertible Note to Common and Preferred Stock [Member]
Debt Conversion, Original Debt, Amount \| $							$ 3,000,000
Exchanged 2021 Notes For Series B-2 Preferred Stock [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)							$ 1,000											$ 1,000
Exchanged 2021 Notes For Common Stock [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)							0.9494											0.9494
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) \| shares												93,742
Conversion of December 2019 Notes into Common Stock [Member]
Debt Conversion, Original Debt, Amount \| $																			$ 17,100,000
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares																			1,777,437
Conversion of December 2019 Notes into Common Stock [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 273.76
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 93.60
Conversion of Stock, Maximum Shares Issued (in shares) \| shares	260,876
The 2019 Notes Converted to Common Stock [Member]
Debt Conversion, Original Debt, Amount \| $					$ 1,200,000														$ 15,863,000		$ 1,200,000
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares					125,000
Optional Exchange Principal Amount [Member]
Convertible Preferred Stock, Conversion Price (in dollars per share)							$ 0.9494											$ 0.9494
Debt instrument convertible exchange price trading days							15 days
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) \| shares														324,312	328,125	1,000,000					125,000
Optional Exchange Principal Amount [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 15.1904
Deerfield Optional Conversion Feature [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 9.60
Conversion of Stock, Maximum Shares Issued (in shares) \| shares	1,777,437
Debt instrument convertible exchange price trading days	15 days
Deerfield Convertible Notes [Member]
Debt Instrument, Interest Rate, Stated Percentage												6.75%								6.75%						9.75%
Deerfield Convertible Notes [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 93.60
Debt instrument convertible exchange floor price	9.328
2021 Notes [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)										$ 17.11
Debt Conversion, Original Debt, Amount \| $										$ 1,000
Debt Conversion, Converted Instrument, Shares Issued (in shares) \| shares										58.4454
Debt Instrument, Interest Rate, Stated Percentage										5.50%
Debt Instrument, Face Amount \| $										$ 86,300,000
Proceeds from Debt, Net of Issuance Costs \| $										82,800,000
Repayments of Long-term Debt, Total \| $										18,600,000
Debt Instrument, Sinking Fund Payment \| $										$ 0
Debt Instrument Repurchase Price Equal to Percentage of Principal Amount										100.00%
Debt Instrument, Cancellation of Debt, Amount \| $				$ 3,037,354		$ 71,418,011
Interest Paid, Excluding Capitalized Interest, Operating Activities \| $				37,354		$ 745,011
Debt Instrument, Percentage of Accrued Interest Paid						50.00%
2021 Notes [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	93.60
Debt Instrument, Cancellation of Debt, Amount \| $				3,037,354
Interest Paid, Excluding Capitalized Interest, Operating Activities \| $				$ 37,354
Debt instrument convertible exchange floor price	9.328
The 2019 Notes [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)				$ 5.85		$ 17.11
Debt Instrument, Interest Rate, Stated Percentage						6.75%
Debt Instrument, Face Amount \| $						$ 71,418,011
Debt Instrument, Percentage of Accrued Interest Paid				50.00%
Debt Instrument, Convertible, Number of Equity Instruments						4,174,051
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share)				$ 0.583	$ 0.38	$ 0.583											$ 0.38				$ 0.38			$ 0.38
Debt Instrument, Convertible, Conversion Restriction Percentage of Common Stock						4.985%
Beneficial Ownership, Cap Limit, Percentage						19.985%
The 2019 Notes [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)				$ 5.85
Debt Instrument, Percentage of Accrued Interest Paid				50.00%
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share)				$ 0.583
January 2020 Note [Member]
Debt Instrument, Face Amount \| $				$ 3,037,354
Paycheck Protection Program CARES Act [Member]
Proceeds from Issuance of Long-term Debt, Total \| $			$ 800,000
Debt Instrument Required Minimum Percentage Allocation to Eligible Payroll Costs		60.00%	75.00%
Debt Instrument Covered Period For Loan Forgiveness		168 days	56 days
January 2020 Notes [Member] \| Subsequent Event [Member]
Debt Instrument, Face Amount \| $				$ 3,037,354
Embedded Deerfield Note Put Option [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	93.60
Convertible Notes 2021 [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 273.76
Debt instrument convertible conversion ratio	0.0036528
Deerfield Facility Agreement [Member]
Line of Credit Facility, Maximum Borrowing Capacity \| $											$ 60,000,000
Debt Instrument, Convertible, Conversion Price (in dollars per share)						$ 5.85
Line of Credit Facility, Interest Rate at Period End							6.75%				9.75%							6.75%										6.75%
Debt Instrument, Interest Rate, Stated Percentage					6.75%									6.75%			6.75%		6.75%		6.75%		6.75%	6.75%	6.75%	9.75%
Convertible Notes Payable, Current \| $					$ 6,980,824									$ 6,980,824			$ 6,980,824		$ 6,980,824		$ 6,980,824		$ 6,980,824	$ 6,980,824	$ 6,980,824
Debt Covenant, Debt Financing Restriction \| $											$ 750,000
Reimbursement of Debt Holders \| $							$ 150,000											$ 150,000
Change in Fair Value of Embedded Conversion Feature \| $																		$ 2,300,000
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share)						$ 0.60
Deerfield Facility Agreement [Member] \| Subsequent Event [Member]
Debt Instrument, Convertible, Conversion Price (in dollars per share)	$ 93.60
Deerfield Facility Agreement [Member] \| Deerfield Warrant [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)											$ 0.78
Deerfield Facility Agreement [Member] \| Deerfield Warrant [Member] \| IPO [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) \| shares											1,923,077
Deerfield Facility Agreement [Member] \| Series D Redeemable Convertible Preferred Stock Reclassified to Common Stock [Member]
Conversion of Stock, Shares Issued (in shares) \| shares													256,410
Deerfield Facility Agreement [Member] \| Series D Redeemable Convertible Preferred Stock [Member]
Own-share Lending Arrangement, Shares, Issued (in shares) \| shares											1,923,077
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) \| shares											14,423,076
Deerfield Facility Agreement [Member] \| Term Notes [Member]
Proceeds from Secured Notes Payable \| $											$ 15,000,000
Deerfield Facility Agreement [Member] \| Deerfield Convertible Notes [Member]
Proceeds from Secured Notes Payable \| $											$ 10,000,000
Debt Instrument, Convertible, Conversion Price (in dollars per share)											$ 5.85

Commitments and Contingencies - Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Amortization of right-of-use assets	$ 31	$ 31	$ 92	$ 92	$ 123
Interest on lease liabilities	4	9	19	31	40
Total finance lease cost	35	40	111	123	163
Operating lease cost	91	124	272	372	473
Short-term lease cost	49	58	160	173	232
Variable lease cost	14	14	41	35	48
Less: sublease income	(40)	(25)	(93)	(75)	(84)
Total lease costs	$ 149	$ 211	$ 491	$ 628	$ 832

Commitments and Contingencies - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Operating cash flows from finance leases	$ 19	$ 31	$ 40
Financing cash flows from finance leases	168	157	207
Operating cash flows from operating leases	334	326	435
Operating cash flows from short-term leases	160	173	232
Operating cash flows from variable lease costs	41	35	48
Finance leases		737	757
Operating leases	$ 20	$ 1,852	$ 1,852

Commitments and Contingencies - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
less: accumulated depreciation and amortization		$ (1,560)	$ (1,253)
Lease liabilities, Finance leases	$ 236	404
Operating lease right-of-use assets	1,357	1,537
Current portion of operating lease liabilities	318	284
Operating lease liabilities, less current portion	1,673	1,901
Total operating lease liabilities	$ 1,991	$ 2,185
Finance leases (years) (Year)	1 year	2 years
Operating leases (years) (Year)	5 years	6 years
Finance leases	7.80%	7.70%
Operating leases	7.50%	7.50%
Property and Equipment, At Cost [Member]
Property and equipment, at cost	$ 1,013	$ 1,013
Accumulated Depreciation and Amortization [Member]
less: accumulated depreciation and amortization	(490)	(398)
Property and Equipment, Net [Member]
Property and equipment, net	523	615
Other Current Liabilities [Member]
Other current liabilities	214	236
Other Noncurrent Liabilities [Member]
Other long-term liabilities	22	168
Operating Lease Right-of-Use Assets [Member]
Operating lease right-of-use assets	1,357	1,537
Current Portion of Operating Lease Liabilities [Member]
Current portion of operating lease liabilities	318	284
Operating Lease Liabilities, Less Current Portion [Member]
Operating lease liabilities, less current portion	$ 1,673	$ 1,901

Commitments and Contingencies - Maturities of lease Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
2021, Finance leases	$ 163	$ 260
2021, Operating leases	460	438
2022, Finance leases	11	163
2022, Operating leases	463	449
2023, Finance leases		11
2023, Operating leases	472	461
2024, Finance leases
2024, Operating leases	484	472
2024
2024		484
Thereafter
Thereafter		420
Total lease payments, Finance leases	247	434
Total lease payments, Operating leases	2,413	2,724
Less: future interest expense, Finance leases	(11)	(30)
Less: future interest expense, Operating leases	(422)	(539)
Lease liabilities, Finance leases	236	404
Lease liabilities, Operating leases	$ 1,991	$ 2,185

Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
Loss Contingency Accrual, Ending Balance	$ 0	$ 0	$ 0
Lessee, Lease, Option to Extend, Maximum Term (Year)	5 years	5 years
Lessee, Lease, Option to Terminate, Term (Year)	1 year	1 year
Operating and Capital Leases, Rent Expense, Net		$ 700	$ 700
Minimum [Member]
Lessee, Lease, Remaining Term of Contract (Year)	1 year	1 year
Capital Lease, Interest Rate		7.19%	7.19%
Maximum [Member]
Lessee, Lease, Remaining Term of Contract (Year)	5 years	6 years
Capital Lease, Interest Rate		9.57%	9.57%

Supply Arrangement (Details Textual) $ in Millions	12 Months Ended
Supply Arrangement (Details Textual) $ in Millions	Dec. 31, 2019 USD ($)	Dec. 31, 2018 USD ($)
Number of Manufacturing Arrangements	1	1
Supply Arrangement Expense	$ 3.2	$ 3.6
Supply Arrangement, Automatic Renewal Period	2 years
Supply Arrangement, Period of Prior Notice	1 year

Preferred Stock and Warrants (Details Textual) - $ / shares				1 Months Ended	4 Months Ended	12 Months Ended		13 Months Ended	15 Months Ended	24 Months Ended
	Dec. 23, 2020	Sep. 03, 2019	Oct. 05, 2018	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2019	Dec. 31, 2018	Sep. 30, 2020	Dec. 31, 2019	Sep. 30, 2020	Dec. 18, 2019	Oct. 31, 2018
Preferred Stock, Shares Authorized (in shares)					10,000,000	10,000,000		10,000,000	10,000,000	10,000,000
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock		4.985%
Conversion of Stock, Maximum Shares Issued (in shares)											28,439,015
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member]
Conversion of Stock, Shares Converted (in shares)					1,576	1,576		1,576
Conversion of Stock, Shares Issued (in shares)				1,659,996	103,749	103,749		103,749
Series A Preferred Stock Converted Into Common Stock [Member]
Conversion Of Stock Shares Issuable If Converted (in shares)												3,192,333
Conversion of Stock, Shares Converted (in shares)									9,577	9,577
Conversion of Stock, Shares Issued (in shares)						69,521	129,998		199,519
Series A Preferred Stock Converted Into Common Stock [Member] \| Subsequent Event [Member]
Convertible Preferred Stock, Conversion Price (in dollars per share)	$ 48.00
Conversion of Stock, Maximum Shares Issued (in shares)	199,519
Series A Preferred Stock [Member]
Preferred Stock, Shares Authorized (in shares)					9,578	9,578		9,578	9,578	9,578
Preferred Stock, Shares Issued, Total (in shares)					9,577	9,577	9,577	9,577	9,577	9,577
Preferred Stock, Shares Outstanding, Ending Balance (in shares)					0	0	3,337	0	0	0
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)			$ 1,000
Convertible Preferred Stock, Conversion Price (in dollars per share)			$ 3
Conversion Of Stock Shares Issuable If Converted (in shares)			3,192,333
Series B-1 Convertible Preferred Stock [Member]
Preferred Stock, Shares Authorized (in shares)					1,576	1,576	0	1,576	1,576	1,576
Preferred Stock, Shares Issued, Total (in shares)					1,576	1,576	0	1,576	1,576	1,576
Preferred Stock, Shares Outstanding, Ending Balance (in shares)					0	0	0	0	0	0
Debt Conversion, Converted Instrument, Shares Issued (in shares)		1,576
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)		$ 1,000
Convertible Preferred Stock, Conversion Price (in dollars per share)		$ 0.9494
Conversion Of Stock Shares Issuable If Converted (in shares)		1,659,996
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock		4.985%
Preferred Stock, Liquidation Preference Per Share (in dollars per share)		$ 0.0001
Conversion of Stock, Shares Issued (in shares)						103,749
Series B-1 Convertible Preferred Stock [Member] \| Subsequent Event [Member]
Convertible Preferred Stock, Conversion Price (in dollars per share)	$ 15.1904
Conversion of Stock, Maximum Shares Issued (in shares)	103,749
Series B-2 Convertible Preferred Stock [Member]
Preferred Stock, Shares Authorized (in shares)					27,000	27,000	0	27,000	27,000	27,000
Preferred Stock, Shares Issued, Total (in shares)					0	0	0	0	0	0
Preferred Stock, Shares Outstanding, Ending Balance (in shares)					0	0	0	0	0	0
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)		1,000
Convertible Preferred Stock, Conversion Price (in dollars per share)		$ 0.9494
Conversion Of Stock Shares Issuable If Converted (in shares)		28,439,015
Series B-2 Convertible Preferred Stock [Member] \| Subsequent Event [Member]
Conversion of Stock, Maximum Shares Issued (in shares)	1,777,437
Debt instrument convertible exchange price trading days	15 days
Preferred Class A [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares)			9,577
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share)			$ 1,000

Common Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares

Sep. 30, 2020

Dec. 31, 2019

Dec. 31, 2018

Common shares reserved for future issuance (in shares)

1,285,186

3,016,722

852,575

Series A Preferred Stock [Member]

Common shares reserved for future issuance (in shares)

69,521

Warrant [Member]

Common shares reserved for future issuance (in shares)

151,442

157,957

Share-based Payment Arrangement [Member]

Common shares reserved for future issuance (in shares)

354,379

324,473

231,493

Possible Future Issuances under the Prior Purchase Agreement [Member]

Common shares reserved for future issuance (in shares)

597,065

Possible Future Issuances Under the Equity Line of Credit [Member]

Common shares reserved for future issuance (in shares)

597,065

Possible Future Issuances Under Equity Incentive Plans [Member]

Common shares reserved for future issuance (in shares)

50,273

5,325

40,557

2021 Notes [Member]

Common shares reserved for future issuance (in shares)

10,958

280,072

January 2020 Note [Member]

Common shares reserved for future issuance (in shares)

34,037

The 2019 Notes [Member]

Common shares reserved for future issuance (in shares)

615,307

199,172

Optional Exchange Principal Amount [Member]

Common shares reserved for future issuance (in shares)

^[1]

1,652,437

^[1]

Convertible Notes Payable [Member]

Common shares reserved for future issuance (in shares)

79,748

75,850

72,975

[1]	Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature

Common Stock and Warrants - Common Stock Activity (Details) - shares	1 Months Ended	3 Months Ended				4 Months Ended	9 Months Ended		12 Months Ended		13 Months Ended	15 Months Ended	24 Months Ended
	Sep. 30, 2019	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Dec. 31, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018	Sep. 30, 2020	Dec. 31, 2019	Sep. 30, 2020
Balance (in shares)		4,201,396	3,547,412	2,271,833			2,271,833	1,653,376	1,653,376	916,021
Common stock issued as a result of Convertible Note conversion (in shares)										37,410
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares)		279			0			0	6,354	1,476
Common stock issued as compensation to third-parties (in shares)		4,668	11,873	2,484
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares)		1,384	4,015	3,806					6,354
Balance (in shares)		4,532,039	4,201,396	3,547,412		2,271,833	4,532,039		2,271,833	1,653,376	4,532,039	2,271,833	4,532,039
2021 Notes Converted To Common Stock [Member]
Common stock issued as a result of Convertible Note conversion (in shares)									93,742
Optional Exchange Principal Amount [Member]
Common stock issued as a result of Convertible Note conversion (in shares)		324,312	328,125	1,000,000					125,000
Equity Line of Credit [Member]
Common stock sold (in shares)			309,971	269,289
Series A Preferred Stock Converted Into Common Stock [Member]
Common stock issued as a result of Convertible Note conversion (in shares)													199,519
Common stock issued as a result of Preferred Stock conversion (in shares)									69,521	129,998		199,519
Prior Purchase Agreement [Member]
Common stock issued as a result of Preferred Stock conversion (in shares)									220,091
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member]
Common stock issued as a result of Preferred Stock conversion (in shares)	1,659,996					103,749			103,749		103,749
First ATM Agreement [Member]
Common stock sold (in shares)									212,579	47,638
Underwriting Public Offering [Member]
Common stock sold (in shares)										520,833

Common Stock and Warrants (Details Textual) - USD ($)						1 Months Ended	4 Months Ended	9 Months Ended	12 Months Ended			13 Months Ended	15 Months Ended	23 Months Ended	24 Months Ended
Common Stock and Warrants (Details Textual) - USD ($)	Sep. 03, 2019	Oct. 25, 2018	Oct. 10, 2018	Oct. 05, 2018	Jun. 02, 2014	Sep. 30, 2019	Dec. 31, 2019	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018	Dec. 31, 2013	Sep. 30, 2020	Dec. 31, 2019	Sep. 04, 2018	Sep. 30, 2020	Dec. 23, 2020	Jun. 30, 2020	Mar. 31, 2020	Dec. 18, 2019	Dec. 31, 2017
Common Stock, Shares Authorized (in shares)							250,000,000	250,000,000	250,000,000	250,000,000		250,000,000	250,000,000		250,000,000
Common Stock, Shares, Issued, Total (in shares)							2,271,833	4,532,039	2,271,833	1,653,376		4,532,039	2,271,833		4,532,039
Proceeds from Issuance of Common Stock										$ 4,828,000
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares)										37,410
Common Stock, Shares, Outstanding, Ending Balance (in shares)							2,271,833	4,532,039	2,271,833	1,653,376		4,532,039	2,271,833		4,532,039		4,201,396	3,547,412		916,021
Conversion of Stock, Maximum Shares Issued (in shares)																			28,439,015
Subsequent Event [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)																120,192
Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)											143,466
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)											$ 5.85
2013 Warrants [Member]
Debt Instrument, Face Amount											$ 3,800,000
Class of Warrant or Right Issued (in shares)											1,079,453
Series D Redeemable Convertible Preferred Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)											1,079,453
Deerfield Warrant [Member]
Class of Warrant or Right Issued (in shares)					14,423,076
Deerfield Warrant [Member] \| Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)					1,923,077
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)					$ 5.85
Warrant Issued to KVK [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		500,000
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 2.30
Class of Warrant or Right, Additional Shares Exercisable for Each Milestones (in shares)		125,000
Warrant Issued to KVK [Member] \| Subsequent Event [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)																$ 36.80
Conversion of Stock, Maximum Shares Issued (in shares)																31,250
Series A Preferred Stock Converted Into Common Stock [Member]
Conversion of Stock, Shares Converted (in shares)													9,577		9,577
Conversion of Stock, Shares Issued (in shares)									69,521	129,998			199,519
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares)															199,519
Series A Preferred Stock Converted Into Common Stock [Member] \| Subsequent Event [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)																$ 48.00
Conversion of Stock, Maximum Shares Issued (in shares)																199,519
2021 Notes Converted To Common Stock [Member]
Conversion of Stock, Shares Issued (in shares)									93,742
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares)	93,742
2021 Notes Converted To Series B-1 Preferred Stock [Member]
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares)	1,576					1,576
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member]
Conversion of Stock, Shares Converted (in shares)							1,576		1,576			1,576
Conversion of Stock, Shares Issued (in shares)						1,659,996	103,749		103,749			103,749
Exchanged 2021 Notes for Series A Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares)				9,577
Conversion of December 2019 Notes into Common Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued (in shares)								1,777,437
Conversion of December 2019 Notes into Common Stock [Member] \| Subsequent Event [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)																$ 93.60
Conversion of Stock, Maximum Shares Issued (in shares)																260,876
Second ATM Agreement [Member]
Stock Issued During Period, Shares, New Issues (in shares)									0
Cowen and Company, LLC [Member]
Stock Issued During Period, Shares, New Issues (in shares)														47,638
Proceeds from Issuance of Common Stock														$ 4,900,000
RBC Capital Markets, LLC [Member] \| Underwriting Agreement [Member]
Stock Issued During Period, Shares, New Issues (in shares)			520,833	520,833

Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Stock based compensation expense	$ 385	$ 1,057	$ 2,034	$ 3,664	$ 4,410	$ 6,495
Research and Development Expense [Member]
Stock based compensation expense	157	400	748	1,196	1,459	1,608
General and Administrative Expense [Member]
Stock based compensation expense	228	657	866	2,468	2,951	3,651
Severance Expense [Member]
Stock based compensation expense			$ 420			$ 1,236

Stock-based Compensation - Black-Scholes Option-pricing Model (Details)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Expected dividend yield	0.00%	0.00%
Minimum [Member]
Risk-free interest rate	1.75%	2.43%
Expected term (in years) (Year)	5 years 182 days	5 years 182 days
Expected volatility	84.82%	83.10%
Maximum [Member]
Risk-free interest rate	2.61%	2.91%
Expected term (in years) (Year)	10 years	6 years 288 days
Expected volatility	85.93%	85.05%

Stock-based Compensation - Schedule of Stock Option Activity (Details) - USD ($)	3 Months Ended		9 Months Ended	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Outstanding, number of options (in shares)			231,477	231,477
Outstanding, weighted average exercise price (in dollars per share)			$ 149.62	$ 149.62
Outstanding, weighted average remaining contractual term (Year)				7 years 229 days	7 years 175 days
Outstanding, aggregate intrinsic value
Granted, number of options (in shares)				143,223
Stock Issued During Period, Shares, Restricted Stock Award, Gross				6,354
Granted, weighted average exercise price (in dollars per share)				$ 29.30
Exercised or released, number of options (in shares)	(279)	0	0	(6,354)	(1,476)
Exercised or released, weighted average exercise price (in dollars per share)
Canceled or forfeited, number of options (in shares)				(42,209)
Canceled or forfeited, weighted average exercise price (in dollars per share)				$ 140.81
Expired, number of options (in shares)				(1,664)
Expired, weighted average exercise price (in dollars per share)				$ 76.80
Outstanding, number of options (in shares)				324,473	231,477
Outstanding, weighted average exercise price (in dollars per share)				$ 100.96	$ 149.62
Exercisable, number of options (in shares)				134,614
Exercisable, weighted average exercise price (in dollars per share)				$ 172.84
Exercisable, weighted average remaining contractual term (Year)				6 years 14 days
Vested and expected to vest, number of options (in shares)				281,356
Vested and expected to vest, weighted average exercise price (in dollars per share)				$ 114.56
Vested and expected to vest, weighted average remaining contractual term (Year)				7 years 109 days

Stock-based Compensation - Information Regarding Currently Outstanding and Exercisable Options (Details) - $ / shares	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Lower range (in dollars per share)	$ 8.2576
Upper range (in dollars per share)	$ 80.00
Options outstanding, number of shares (in shares)	324,473	231,477
Outstanding, weighted average remaining contractual term (Year)	7 years 229 days	7 years 175 days
Exercisable, number of options (in shares)	134,614
Exercisable, weighted average remaining contractual term (Year)	6 years 14 days
Exercise Price Range One [Member]
Lower range (in dollars per share)	$ 8.2576
Upper range (in dollars per share)	$ 80.00
Options outstanding, number of shares (in shares)	181,415
Outstanding, weighted average remaining contractual term (Year)	8 years 262 days
Exercisable, number of options (in shares)	29,920
Exercisable, weighted average remaining contractual term (Year)	7 years 69 days
Exercise Price Range Two [Member]
Lower range (in dollars per share)	$ 80.01
Upper range (in dollars per share)	$ 160.00
Options outstanding, number of shares (in shares)	68,914
Outstanding, weighted average remaining contractual term (Year)	6 years 270 days
Exercisable, number of options (in shares)	37,478
Exercisable, weighted average remaining contractual term (Year)	5 years 226 days
Exercise Price Range Three [Member]
Lower range (in dollars per share)	$ 160.01
Upper range (in dollars per share)	$ 240.00
Options outstanding, number of shares (in shares)	29,489
Outstanding, weighted average remaining contractual term (Year)	5 years 343 days
Exercisable, number of options (in shares)	23,821
Exercisable, weighted average remaining contractual term (Year)	5 years 328 days
Exercise Price Range Four [Member]
Lower range (in dollars per share)	$ 240.01
Upper range (in dollars per share)	$ 320.00
Options outstanding, number of shares (in shares)	23,719
Outstanding, weighted average remaining contractual term (Year)	5 years 255 days
Exercisable, number of options (in shares)	22,459
Exercisable, weighted average remaining contractual term (Year)	5 years 244 days
Exercise Price Range Five [Member]
Lower range (in dollars per share)	$ 320.01
Upper range (in dollars per share)	$ 327.20
Options outstanding, number of shares (in shares)	20,936
Outstanding, weighted average remaining contractual term (Year)	5 years 248 days
Exercisable, number of options (in shares)	20,936
Exercisable, weighted average remaining contractual term (Year)	5 years 248 days

Stock-based Compensation - Nonvested Stock Option Awards (Details) - $ / shares	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Lower range (in dollars per share)	$ 8.2576
Upper range (in dollars per share)	$ 80.00
Number of unvested shares (in shares)	189,859	116,642
Exercise Price Range One [Member]
Lower range (in dollars per share)	$ 8.2576
Upper range (in dollars per share)	$ 80.00
Exercise Price Range One [Member] \| Minimum [Member]
Number of unvested shares (in shares)	151,495
Exercise Price Range One [Member] \| Maximum [Member]
Number of unvested shares (in shares)		39,646
Exercise Price Range Two [Member]
Lower range (in dollars per share)	$ 80.01
Upper range (in dollars per share)	$ 160.00
Exercise Price Range Two [Member] \| Minimum [Member]
Number of unvested shares (in shares)	31,436
Exercise Price Range Two [Member] \| Maximum [Member]
Number of unvested shares (in shares)		51,165
Exercise Price Range Three [Member]
Lower range (in dollars per share)	$ 160.01
Upper range (in dollars per share)	$ 240.00
Exercise Price Range Three [Member] \| Minimum [Member]
Number of unvested shares (in shares)	5,668
Exercise Price Range Three [Member] \| Maximum [Member]
Number of unvested shares (in shares)		11,659
Exercise Price Range Four [Member]
Lower range (in dollars per share)	$ 240.01
Upper range (in dollars per share)	$ 320.00
Exercise Price Range Four [Member] \| Minimum [Member]
Number of unvested shares (in shares)	1,260
Exercise Price Range Four [Member] \| Maximum [Member]
Number of unvested shares (in shares)		8,740
Exercise Price Range Five [Member]
Lower range (in dollars per share)	$ 320.01
Upper range (in dollars per share)	$ 327.20
Exercise Price Range Five [Member] \| Minimum [Member]
Number of unvested shares (in shares)
Exercise Price Range Five [Member] \| Maximum [Member]
Number of unvested shares (in shares)		5,432

Stock-based Compensation (Details Textual)			3 Months Ended						9 Months Ended		12 Months Ended
Stock-based Compensation (Details Textual)	Dec. 23, 2020 $ / shares	Jan. 01, 2020 shares	Sep. 30, 2020 USD ($) shares	Jun. 30, 2020 shares	Mar. 31, 2020 shares	Sep. 30, 2019 USD ($) shares	Jun. 30, 2019 shares	Mar. 31, 2019 shares	Sep. 30, 2020 USD ($) shares	Sep. 30, 2019 USD ($) shares	Dec. 31, 2019 USD ($) $ / shares shares	Dec. 31, 2018 USD ($) $ / shares shares
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) \| shares			1,384	4,015	3,806						6,354
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) \| shares			279			0				0	6,354	1,476
Stock Issued During Period, Value, Stock Options Exercised \| $												$ 68,000
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate											0.00%	0.00%
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value \| $ / shares											$ 1.43	$ 4.05
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value \| $											$ 4,900,000	$ 5,900,000
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total \| $											$ 3,800,000
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition											2 years 105 days
Share-based Payment Arrangement, Expense \| $			$ 385,000			$ 1,057,000			$ 2,034,000	$ 3,664,000	$ 4,410,000	6,495,000
Performance Shares [Member]
Share-based Payment Arrangement, Expense \| $			$ 0			$ 0			$ 300,000	$ 0	$ 0	$ 0
Subsequent Event [Member]
Reverse stock split ratio	0.0625
Subsequent Event [Member] \| Granted In 2018 [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value \| $ / shares	$ 64.80
Subsequent Event [Member] \| Granted In 2019 [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value \| $ / shares	$ 22.88
2014 Equity Incentive Plan [Member]
Common Stock Reserved For Issuance Annual Increase Percentage		4.00%
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) \| shares			408,167						408,167		317,291
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Reserved for Issuance, Incremental Percentage of Capital Stock Outstanding									4.00%		4.00%
Increase in Common Stock Reserved for Issuance (in shares) \| shares		90,876
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) \| shares			1,384			0	2,454	2,650	9,205	5,104	1,250
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) \| shares			279			0			279	0	0	1,476
Stock Issued During Period, Value, Stock Options Exercised \| $												$ 68,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value \| $												$ 69,000
2014 Equity Incentive Plan [Member] \| Subsequent Event [Member]
Increase in Common Stock Reserved for Issuance (in shares) \| shares		90,876

Fair Value of Financial Instruments - Reconciliation of Beginning and Ending Balances for Derivative and Warrant Liability Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Balance as of beginning of period	$ 38	$ 1,437	$ 96	$ 1,845	$ 1,845	$ 7,709
Gain on extinguishment of debt						(2)
Adjustment to fair value	115	(1,168)	57	(1,576)	(1,749)	(5,862)
Balance as of end of period	$ 153	$ 269	$ 153	$ 269	$ 96	$ 1,845

Fair Value of Financial Instruments (Details Textual) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Millions	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
The 2019 Notes [Member]
Long-term Debt, Fair Value	$ 52.9	$ 57.0
Deerfield Facility Agreement [Member] \| Deerfield Convertible Notes [Member]
Long-term Debt, Fair Value	6.9	6.0	$ 6.2
Deerfield Facility Agreement [Member] \| Term Notes [Member]
Long-term Debt, Fair Value	$ 2.9	$ 2.4	$ 51.2

Income Taxes - Schedule of Reconciliation of Difference Between Benefit for Income Taxes and Income Taxes at Statutory U.S. Federal Income Tax Rate (Details)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Federal statutory rate	21.00%	21.00%
Change in valuation allowance	(28.52%)	(30.44%)
Return to provision and deferred true-up		0.38%
Change in rate	(0.33%)	0.03%
State tax benefit (net of federal)	3.39%	4.35%
Warrant liability	1.71%	2.02%
State research and development credit	0.09%	0.22%
Federal research and development credit	1.44%	3.30%
Amortization	(0.29%)
Stock-based compensation	(1.10%)	(0.63%)
Other	2.70%	(0.01%)
Federal income tax provision effective rate	0.09%	0.22%

Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2019	Dec. 31, 2018
Net operating loss carryforwards	$ 56,827	$ 51,269
Research and development tax carryforward	6,412	5,657
Other deferred tax assets	4,488	3,437
Total gross deferred tax assets	67,726	60,363
Property and equipment		161
Other deferred tax liabilities	540	10
Total gross deferred tax liabilities	540	171
Deferred tax assets less liabilities	67,186	60,192
Valuation allowance	(67,186)	(60,192)
Net deferred tax asset (liability)

Income Taxes - Federal Net Operating Loss Carryforward and Research Activities Credit (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Net Operating Loss Carryforwards	$ 217,085
Research Activities Tax Credit	6,412	$ 5,657
Tax Year 2007 [Member]
Net Operating Loss Carryforwards	454
Research Activities Tax Credit	$ 30
Expiration	2027
Tax Year 2008 [Member]
Net Operating Loss Carryforwards	$ 1,178
Research Activities Tax Credit	$ 65
Expiration	2028
Tax Year 2009 [Member]
Net Operating Loss Carryforwards	$ 3,060
Research Activities Tax Credit	$ 176
Expiration	2029
Tax Year 2010 [Member]
Net Operating Loss Carryforwards	$ 3,423
Research Activities Tax Credit	$ 149
Expiration	2030
Tax Year 2011 [Member]
Net Operating Loss Carryforwards	$ 9,929
Research Activities Tax Credit	$ 176
Expiration	2031
Tax Year 2012 [Member]
Net Operating Loss Carryforwards
Research Activities Tax Credit	$ 170
Expiration	2032
Tax Year 2013 [Member]
Net Operating Loss Carryforwards	$ 4,353
Research Activities Tax Credit	$ 133
Expiration	2033
Tax Year 2014 [Member]
Net Operating Loss Carryforwards	$ 15,897
Research Activities Tax Credit	$ 894
Expiration	2034
Tax Year 2015 [Member]
Net Operating Loss Carryforwards	$ 23,496
Research Activities Tax Credit	$ 598
Expiration	2035
Tax Year 2016 [Member]
Net Operating Loss Carryforwards	$ 41,580
Research Activities Tax Credit	$ 745
Expiration	2036
Tax Year 2017 [Member]
Net Operating Loss Carryforwards	$ 34,776
Research Activities Tax Credit	$ 652
Expiration	2037
Tax Year 2018 [Member]
Net Operating Loss Carryforwards	$ 56,155
Research Activities Tax Credit	2,272
Tax Year 2019 [Member]
Net Operating Loss Carryforwards	22,784
Research Activities Tax Credit	$ 352

Income Taxes (Details Textual) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
Income Taxes (Details Textual) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
State and Local Income Tax Expense (Benefit), Continuing Operations, Total					$ 22,000	$ (126,000)
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total	$ (3,043,000)	$ 3,066,000	$ (7,938,000)	$ (18,499,000)	(24,544,000)	$ (56,592,000)
Operating Loss Carryforwards, Total					217,085,000
State and Local Jurisdiction [Member]
Operating Loss Carryforwards, Total					$ 136,000,000
Operating Loss Carryforwards, Expiration, Beginning Year					2027
Operating Loss Carryforwards, Expiration, Ending Year					2037

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=68072869&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI http://asc.fasb.org/extlink&oid=120395209&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI http://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI http://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI http://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Net (Loss) Income Per Share - Anti-dilutive Securities (Details) - shares

3 Months Ended

9 Months Ended

12 Months Ended

Sep. 30, 2020

Sep. 30, 2019

Sep. 30, 2020

Sep. 30, 2019

Dec. 31, 2019

Dec. 31, 2018

Convertible Debt Securities [Member]

1,234,913

2,342,501

1,234,913

2,584,155

2,414,332

812,018

79,748

74,557

79,748

74,557

75,850

72,975

2021 Notes [Member]

January 2020 Note [Member]

^[1]

1,947,924

^[1]

1,947,924

^[1]

10,958

280,072

34,037

The 2019 Notes [Member]

Share-based Payment Arrangement [Member]

615,307

1,851,609

^[2]

Warrants to Purchase Common Stock [Member]

354,379

288,770

354,379

288,770

324,473

231,493

Series A Convertible Preferred Stock [Member]

151,442

31,250

151,442

157,957

Series B-1 Convertible Preferred Stock [Member]

69,521

51,941

[1]	Inclusive of 1,777,437 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount.
[2]	Inclusive of 1,652,437 of shares of Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature.

Net (Loss) Income Per Share - Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended		12 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Net income	$ (3,009)	$ 859	$ (5,754)	$ 3,063	$ (9,257)	$ (12,291)	$ (7,904)	$ (18,485)	$ (24,522)	$ (56,466)
Less: Net income attributable to participating securities				(348)
Net income attributable to shares of common stock				2,715
Less: Dividends declared or accumulated
Undistributed net income attributable to shares of common stock, basic				$ 2,715
Weighted average number of shares of common stock outstanding (in shares)	4,425,474			1,882,831			3,794,840	1,776,005
Basic net income per share of common stock (in dollars per share)	$ (0.68)			$ 1.44			$ (2.08)	$ (10.41)
Less: Fair value adjustment income related to embedded Warrant Put Option				$ (135)
Net income attributable to shares of common stock, diluted				$ 1,909
Weighted average number of shares of common stock outstanding, diluted (in shares)	4,425,474			1,979,422			3,794,840	1,776,005
Diluted net income per share of common stock (in dollars per share)	$ (0.68)			$ 0.96			$ (2.08)	$ (10.41)
Series A Convertible Preferred Stock [Member]
Dilutive effect of Preferred Stock (in shares)				70,000
Series B-1 Convertible Preferred Stock [Member]
Dilutive effect of Preferred Stock (in shares)				27,000
Warrant [Member] \| Deerfield Warrant [Member]
Less: Fair value adjustment income related to Warrant liability				$ (1,019)
Dilutive effect of Warrant (in shares)
Warrant [Member] \| KVK Warrant Liability [Member]
Less: Fair value adjustment income related to Warrant liability

Net Loss Per Share - Summary of Computation of Basic and Diluted Net Loss and Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended		12 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018
Net income	$ (3,009)	$ 859	$ (5,754)	$ 3,063	$ (9,257)	$ (12,291)	$ (7,904)	$ (18,485)	$ (24,522)	$ (56,466)
Weighted average number of shares of common stock - basic and diluted (in shares)									1,853,348	1,120,626
Net loss per share - basic and diluted (in dollars per share)									$ (13.23)	$ (50.39)