Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 01, 2020 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Entity Registrant Name | Onconova Therapeutics, Inc. | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 168,666,070 | |
Entity Central Index Key | 0001130598 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 31,036,000 | $ 22,726,000 |
Receivables | 45,000 | 98,000 |
Prepaid expenses and other current assets | 795,000 | 650,000 |
Total current assets | 31,876,000 | 23,474,000 |
Property and equipment, net | 47,000 | 50,000 |
Other non-current assets | 150,000 | 150,000 |
Total assets | 32,073,000 | 23,674,000 |
Current liabilities: | ||
Accounts payable | 4,183,000 | 4,271,000 |
Accrued expenses and other current liabilities | 2,501,000 | 3,795,000 |
Deferred revenue | 226,000 | 226,000 |
Total current liabilities | 6,910,000 | 8,292,000 |
Warrant liability | 176,000 | 113,000 |
Deferred revenue, non-current | 3,639,000 | 3,695,000 |
Total liabilities | 10,725,000 | 12,100,000 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 5,000,000 authorized at March 31, 2020 and December 31, 2019, none issued and outstanding at March 31, 2020 and December 31, 2019 | ||
Common stock, $0.01 par value, 250,000,000 authorized at March 31, 2020 and December 31, 2019, 167,416,070 and 111,167,352 shares issued and outstanding at March 31, 2020 and December 31, 2019 | 1,674,000 | 1,112,000 |
Additional paid in capital | 428,189,000 | 413,879,000 |
Accumulated other comprehensive loss | (24,000) | (18,000) |
Accumulated deficit | (408,491,000) | (403,399,000) |
Total stockholders' equity | 21,348,000 | 11,574,000 |
Total liabilities and stockholders' equity | $ 32,073,000 | $ 23,674,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 167,416,070 | 111,167,352 |
Common stock, shares outstanding | 167,416,070 | 111,167,352 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Condensed Consolidated Statements of Operations | ||
Revenue | $ 52,000 | $ 68,000 |
Operating expenses: | ||
General and administrative | 1,807,000 | 3,234,000 |
Research and development | 3,370,000 | 4,075,000 |
Total operating expenses | 5,177,000 | 7,309,000 |
Loss from operations | (5,125,000) | (7,241,000) |
Change in fair value of warrant liability | (63,000) | (427,000) |
Other income, net | 96,000 | 68,000 |
Net loss | $ (5,092,000) | $ (7,600,000) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.03) | $ (1.29) |
Basic and diluted weighted average shares outstanding (in shares) | 160,346,087 | 5,890,098 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net loss | $ (5,092,000) | $ (7,600,000) |
Foreign currency translation adjustments, net | (6,000) | (6,000) |
Other comprehensive loss, net of tax | (6,000) | (6,000) |
Comprehensive loss | $ (5,098,000) | $ (7,606,000) |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive loss | Total |
Balance at Dec. 31, 2018 | $ 57,000 | $ 387,238,000 | $ (381,896,000) | $ (12,000) | $ 5,387,000 |
Balance (in shares) at Dec. 31, 2018 | 5,674,220 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (7,600,000) | (7,600,000) | |||
Other comprehensive loss | (6,000) | (6,000) | |||
Stock-based compensation | 650,000 | 650,000 | |||
Issuance of common stock upon exercise of warrants | $ 2,000 | 31,000 | 33,000 | ||
Issuance of common stock upon exercise of warrants (in shares) | 220,784 | ||||
Balance at Mar. 31, 2019 | $ 59,000 | 387,919,000 | (389,496,000) | (18,000) | (1,536,000) |
Balance (in shares) at Mar. 31, 2019 | 5,895,004 | ||||
Balance at Dec. 31, 2019 | $ 1,112,000 | 413,879,000 | (403,399,000) | (18,000) | $ 11,574,000 |
Balance (in shares) at Dec. 31, 2019 | 111,167,352 | 111,167,352 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (5,092,000) | $ (5,092,000) | |||
Other comprehensive loss | (6,000) | (6,000) | |||
Stock-based compensation | 93,000 | 93,000 | |||
Issuance of common stock, Net | $ 276,000 | 8,786,000 | 9,062,000 | ||
Issuance of common stock, net (in shares) | 27,662,518 | ||||
Issuance of common stock upon exercise of warrants | $ 286,000 | 5,431,000 | 5,717,000 | ||
Issuance of common stock upon exercise of warrants (in shares) | 28,586,200 | ||||
Balance at Mar. 31, 2020 | $ 1,674,000 | $ 428,189,000 | $ (408,491,000) | $ (24,000) | $ 21,348,000 |
Balance (in shares) at Mar. 31, 2020 | 167,416,070 | 167,416,070 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating activities: | ||
Net loss | $ (5,092,000) | $ (7,600,000) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,000 | 8,000 |
Change in fair value of warrant liabilities | 63,000 | 427,000 |
Stock compensation expense | 93,000 | 650,000 |
Changes in assets and liabilities: | ||
Receivables | 53,000 | |
Prepaid expenses and other current assets | (145,000) | |
Accounts payable | (88,000) | 295,000 |
Accrued expenses and other current liabilities | (1,294,000) | (324,000) |
Deferred revenue | (56,000) | (57,000) |
Net cash used in operating activities | (6,463,000) | (6,601,000) |
Financing activities: | ||
Proceeds from the sale of common stock and warrants, net of costs | 9,062,000 | |
Proceeds from the exercise of warrants | 5,717,000 | 33,000 |
Net cash provided by financing activities | 14,779,000 | 33,000 |
Effect of foreign currency translation on cash | (6,000) | (6,000) |
Net increase (decrease) in cash and cash equivalents | 8,310,000 | (6,574,000) |
Cash and cash equivalents at beginning of period | 22,726,000 | 16,970,000 |
Cash and cash equivalents at end of period | $ 31,036,000 | $ 10,396,000 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2020 | |
Nature of Business | |
Nature of Business | 1. Nature of Business The Company Onconova Therapeutics, Inc. (the "Company") was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The Company's headquarters are located in Newtown, Pennsylvania. The Company is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule product candidates primarily to treat cancer. The Company has proprietary targeted cancer agents designed to work against specific cellular pathways that are important to cancer cells. We believe that the product candidates in our pipeline have the potential to be efficacious in a variety of cancers. The Company has three clinical-stage product candidates and several preclinical programs. During 2012, Onconova Europe GmbH was established as a wholly owned subsidiary of the Company for the purpose of further developing business in Europe. The Company has entered into several license and collaboration agreements. In 2011, the Company entered into a license agreement, as subsequently amended, with SymBio Pharmaceuticals Limited ("SymBio"), which grants SymBio certain rights to commercialize rigosertib in Japan and Korea. In December 2017, the Company entered into a license and collaboration agreement with HanX for the further development, registration and commercialization of ON 123300 in Greater China. ON 123300 is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. Under the terms of the agreement, the Company received an upfront payment, and will receive regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX provides all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Company and HanX also intended for these studies to comply with the FDA standards. Accordingly, such studies may be used by the Company for an IND filing with the FDA. The Chinese IND was approved in January 2020. The Company plans to file a US IND related to 123300 after obtaining the required manufacturing data. The cGMP manufacturer for ON 123300 has been identified and qualified. It is anticipated that the cGMP API would be available in 4-6 months. Subsequently, the drug product will be manufactured with an anticipated filing of an IND in Q4 of 2020. The Company maintains global rights outside of China. On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as "Pint"). Under the terms of the agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical product containing rigosertib in all uses of rigosertib in certain Latin America countries. In May 2019, the Company entered into a License and Collaboration Agreement (the "HanX License Agreement") with HanX Biopharmaceuticals, Inc. ("HanX"). Under the terms of the HanX License Agreement, the Company granted HanX an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical product (the "HanX Product") containing rigosertib in all uses of rigosertib or the HanX Product in humans therapeutics uses in the People's Republic of China, Hong Kong, Macau and Taiwan (the "HanX Territory"). In connection with the License Agreement, the Company also entered into a Securities Purchase Agreement with each of HanX and Abundant New Investments Ltd. ("Abundant"), an affiliate of HanX (each, a "Securities Purchase Agreement" and together, the "Securities Purchase Agreements"). HanX did not fulfill its obligations under the HanX License Agreement and in January 2020, in accordance with the terms of the HanX License Agreement, the HanX License Agreement was deemed to be void ab initio. Upon this termination, the rights to HanX Product in the HanX Territory reverted to the Company in accordance with the terms of the HanX License Agreement. In addition, the Securities Purchase Agreements terminated automatically effective upon the termination of the HanX License Agreement in accordance with the Securities Purchase Agreements. In November 2019, the Company entered into a Distribution, License and Supply Agreement (the "Knight License Agreement") with Knight Therapeutics Inc. ("Knight"). Under the terms of the Knight License Agreement, the Company granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the "Knight Licensed Product") containing rigosertib for Canada (and Israel should Knight exercise its option) (the "Knight Territory") and in human uses (the "Field"), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the Knight Licensed Product in the Knight Territory and in the Field. Knight has also agreed to obtain from the Company us all of its requirements of the Knight Licensed Products for the Knight Territory, and the Company has agreed to supply Knight with all of its requirements of the Knight Licensed Products. In December 2019, the Company entered into a Distribution, License and Supply Agreement (the "STA License Agreement") with Specialised Therapeutics Asia Pte. Ltd. ("STA"). Under the terms of the STA License Agreement, the Company granted STA (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the "STA Licensed Product") containing rigosertib for Australia and New Zealand (the "STA Territory") and in human uses (the "Field"), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the STA Licensed Product in the STA Territory and in the Field. STA has also agreed to obtain from the Company all of its requirements of the STA Licensed Products for the STA Territory, and the Company has agreed to supply STA with all of its requirements of the STA Licensed Products. Liquidity The Company has incurred recurring operating losses since inception. For the three months ended March 31, 2020, the Company incurred a net loss of $5,092,000 and as of March 31, 2020 the Company had generated an accumulated deficit of $408,491,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its preclinical programs, strategic alliances and its administrative organization. At March 31, 2020, the Company had cash and cash equivalents of $31,036,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. In February and March 2019 the Company implemented a workforce reduction. Six employees were terminated, which represented approximately 24% of the Company's workforce. A severance related charge of approximately $1,843,000, which included a non-cash charge of approximately $415,000 related to the accelerated vesting of outstanding stock options, was recorded in the three months ended March 31, 2019. Of the total severance related charge of $1,843,000; $1,562,000 was recorded in general and administrative operating expenses and $281,000 was recorded in research and development operating expenses. The severance expense was paid in periodic amounts through February 2020. On September 25, 2019 the Company closed on an offering of common stock to certain investors. The Company issued 2,198,938 shares of common stock and amended warrants for the purchase of 2,198,938 shares of common stock. The investors, who were also holders of the Company's preferred stock warrants issued in February 2018 and/or May 2018, received a warrant amendment under which a certain number of such investors' preferred stock warrants received a reduction in exercise price and an extension of term. Net proceeds from the sale of common stock and the amendment of preferred stock warrants were approximately $3.3 million. In November 2019, the Company closed on an offering of units of common stock and warrants. The Company issued 30,250,000 shares of common stock, pre-funded warrants to purchase 24,750,000 shares of common stock, and common stock warrants to purchase 55,000,000 shares of common stock. Net proceeds were approximately $9.7 million. On December 10, 2019, the Company closed on an offering of units of common stock and warrants. The Company issued 14,326,648 shares of common stock and common stock warrants to purchase 7,163,324 shares of common stock. Net proceeds were approximately $4.4 million. On December 19, 2019, the Company also closed on an offering of units of common stock and warrants. The Company issued 13,878,864 shares of common stock and common stock warrants to purchase 6,939,432 shares of common stock. Net proceeds were approximately $4.4 million. During 2019, pre-funded warrants were exercised for 23,720,784 shares of common stock and net proceeds were $35,000. Also during 2019, common warrants were exercised for 21,014,378 shares of common stock and net proceeds were approximately $4.9 million. On January 3, 2020, the Company closed on an offering of common stock. The Company issued 27,662,518 shares of common stock and net proceeds were approximately $9.0 million. In addition, during the quarter ended March 31, 2020; 28,586,200 warrants from the November 2019 offering have been exercised, resulting in proceeds of $5.7 million. The Company has and may continue to delay, scale-back, or eliminate certain of its research and development activities and other aspects of its operations until such time as the Company is successful in securing additional funding. The Company is exploring various dilutive and non-dilutive sources of funding, including equity financings, strategic alliances, business development and other sources. The future success of the Company is dependent upon its ability to obtain additional funding. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all. The Company currently anticipates that current cash and cash equivalents will be sufficient to meet its anticipated cash requirements into the third quarter of 2021. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiary, Onconova Europe GmbH. All significant intercompany transactions have been eliminated. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019, the consolidated statements of stockholders’ equity (deficit) for the three months ended March 31, 2020 and 2019 and the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2020, the results of its operations for the three months ended March 31, 2020 and 2019, and its cash flows for the three months ended March 31, 2020 and 2019. The financial data and other information disclosed in these notes related to the three months ended March 31, 2020 and 2019 are unaudited. The results for the three months ended March 31, 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2019 included in the Company’s annual report on Form 10-K filed with the SEC on March 27, 2020. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics. Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2019 included in the Company’s annual report on Form 10-K filed with the SEC on March 27, 2020. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. Fair Value Measurements The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the warrant liability is discussed in Note 7, “Fair Value Measurements.” Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted effective January 1, 2018 using the modified retrospective method. There was no material impact to our financial position and results of operations as a result of the adoption. The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company derives revenue from collaboration and licensing agreements and from the sale of products associated with material transfer, collaboration and supply agreements. License, Collaboration and Other Revenues The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success. Licensing of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees 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 performance obligations, 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 and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : At the inception of each arrangement that includes development milestone payments, 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 will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development 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 revenues and earnings in their period of adjustment. Manufacturing supply services. Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment. Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements. Leases The Company accounts for leases in accordance with Accounting Standards Codification Topic 842, Leases (ASC 842), which the Company adopted effective January 1, 2019. The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Right of Use (ROU) Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short term leases (term of 12 months or less) on the balance sheet, and not separating lease and non-lease components. At January 1, 2019 and March 31, 2020 the Company had one lease, which was for office space. The lease qualifies for the short term lease exception. Consequently, no ROU Asset or Lease Liability was recorded. The lease payments are being recognized as an expense on a straight-line basis over the lease term. Lease payments for the three months ended March 31, 2020 were $45,000. Remaining payments due under the lease at March 31, 2020 are $166,000. Recent Accounting Pronouncements In February 2016 and through subsequent amendments, the FASB issued guidance which supersedes much of the previous guidance for leases. The new guidance requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all the leases with terms greater than twelve months. Based on certain criteria, leases are classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. The guidance was effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors were permitted to recognize and measure leases at the date of adoption using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of the new guidance, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. The Company adopted the guidance in ASC 842 effective January 1, 2019 using the modified retrospective method, which does not require the restatement of prior period amounts. There was no impact to the Company’s financial position and results of operations as a result of the adoption. In August 2018, the FASB issued guidance which changes the disclosure requirements for fair value measurement. The guidance amends the disclosure requirements in ASC Topic 820 by adding, changing, or removing certain disclosures. The guidance is effective for fiscal years beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020. There was no impact to the Company’s financial position, results of operations or financial statement disclosures as a result of the adoption. In November 2018, the FASB issued guidance, which clarifies the interaction between ASC Topic 808, Collaborative Arrangements , and ASC Topic 606, Revenue from Contracts with Customers . The guidance, among other items, clarifies that certain transactions between collaborative participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. The guidance is effective for fiscal years beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020. There was no impact to the Company’s financial position and results of operations as a result of the adoption. In June 2016, the FASB issued new guidance on the accounting for credit losses on financial instruments. The guidance was amended in November 2019. The new guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The guidance is effective for fiscal years beginning after December 15, 2022, and interim periods within those years, with early adoption permitted. The Company is evaluating the impact of the adoption of the standard on its consolidated financial statements. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2020 | |
Revenue. | |
Revenue | 3. Revenue The Company’s revenue during the three ended March 31, 2020 and 2019 was from its license and collaboration agreement with SymBio. Three Months Ended March 31, 2020 2019 Symbio Upfront license fee recognition over time $ 56,000 $ 57,000 Supplies and other (4,000) 11,000 $ 52,000 $ 68,000 Deferred revenue is as follows: Symbio Upfront Payment Deferred balance at December 31, 2019 $ 3,921,000 Recognition to revenue 56,000 Deferred balance at March 31, 2020 $ 3,865,000 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 3 Months Ended |
Mar. 31, 2020 | |
Net Loss Per Share of Common Stock | |
Net Loss Per Share of Common Stock | 4. Net Loss Per Share of Common Stock The following potentially dilutive securities outstanding at March 31, 2020 and 2019 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive (reflects the number of common shares as if the dilutive securities had been converted to common stock): March 31, 2020 2019 Warrants 27,373,567 5,504,722 Stock options 1,017,393 345,794 28,390,960 5,850,516 |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2020 | |
Warrants | |
Warrants | 5. Warrants Common Stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging - Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. Some of the Company’s warrants are classified as liabilities because in certain circumstances they could require cash settlement. Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were converted to common stock) for the three months ended March 31, 2020 is as follows: Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants March 31, Description Classification Price Date 2019 Issued / Amended Exercised Expired/ Amended 2020 Non-tradable warrants Liability $ 172.50 July 2021 6,456 — — — 6,456 Tradable warrants Liability $ 73.80 July 2021 212,801 — — — 212,801 Non-tradable pre-funded warrants Equity $ 0.15 July 2023 394 — — — 394 Non-tradable warrants Equity $ 1.60 December 2022 392,834 — — — 392,834 Non-tradable warrants Equity $ 14.10 March 2021 5,000 — — — 5,000 Non-tradable warrants Equity $ 21.15 March 2021 8,333 — — — 8,333 Non-tradable warrants Equity $ 7.7895 June 2021 15,000 — — — 15,000 Non-tradable pre-funded warrants Equity $ 0.15 none 52,834 — — — 52,834 Non-tradable warrants Equity $ 1.600 December 2022 1,806,104 — — — 1,806,104 Non-tradable pre-funded warrants Equity $ 0.15 none 74,617 — — — 74,617 Non-tradable warrants Equity $ 2.00 September 2023 109,585 — — — 109,585 Non-tradable pre-funded warrants Equity $ 0.0001 none 1,250,000 — — — 1,250,000 Non-tradable warrants Equity $ 0.20 November 2024 41,037,000 — (28,586,200) — 12,450,800 Non-tradable warrants Equity $ 0.250 November 2024 2,521,875 — — — 2,521,875 Non-tradable warrants Equity $ 0.287 December 2024 3,581,662 — — — 3,581,662 Non-tradable warrants Equity $ 0.43625 December 2024 716,332 — — — 716,332 Non-tradable warrants Equity $ 0.298 December 2024 3,469,716 — — — 3,469,716 Non-tradable warrants Equity $ 0.45030 December 2024 693,943 — — — 693,943 Non-tradable warrants Equity $ 0.45190 December 2023 — 1,383,126 — — 1,383,126 55,954,486 1,383,126 (28,586,200) — 28,751,412 |
Balance Sheet Detail
Balance Sheet Detail | 3 Months Ended |
Mar. 31, 2020 | |
Balance Sheet Detail | |
Balance Sheet Detail | 6. Balance Sheet Detail Prepaid expenses and other current assets: March 31, December 31, 2020 2019 Research and development $ 366,000 $ 321,000 Manufacturing 39,000 25,000 Insurance 168,000 164,000 Other 222,000 140,000 $ 795,000 $ 650,000 Property and equipment: March 31, December 31, 2020 2019 Property and equipment $ 2,283,000 $ 2,283,000 Accumulated depreciation (2,236,000) (2,233,000) $ 47,000 $ 50,000 Accrued expenses and other current liabilities: March 31, December 31, 2020 2019 Research and development $ 1,863,000 $ 2,016,000 Employee compensation 526,000 1,537,000 Professional fees 112,000 242,000 $ 2,501,000 $ 3,795,000 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 7. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. On January 5, 2016, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with an institutional investor providing for the issuance and sale by the Company of 12,912 shares of Common Stock, at a purchase price of $142.50 per share and warrants to purchase up to 6,456 shares of Common Stock (the “Warrants”) for aggregate gross proceeds of $1,840,000. The Company has classified the warrants as a liability (see Note 5). The estimated fair value using the Black-Scholes pricing model was approximately $0 at March 31, 2020 and December 31, 2019. On July 29, 2016 the Company closed on a Rights Offering, issuing 239,986 shares of Common Stock, 212,801 Tradable Warrants and 43,760 Pre-Funded Warrants. The Tradable Warrants are exercisable for a period of five years for one share of Common Stock at an exercise price of $73.80 per share. After the one-year anniversary of issuance, the Company may redeem the Tradable Warrants for $0.001 per Tradable Warrant if the volume weighted average price of its Common Stock is above $184.50 for each of 10 consecutive trading days. The Company has classified the Tradable Warrants as a liability (see Note 5). The Tradable Warrants have been listed on the Nasdaq Capital Market since issuance and the Company regularly monitors the trading activity. The Company has determined that an active and orderly market for the Tradable Warrants has developed and that the Nasdaq Capital Market price is the best indicator of fair value of the warrant liability. The quoted market price was used to determine the fair value at December 31, 2019 and March 31, 2020. The Company estimated the fair value of the non-tradable warrant liability at March 31, 2020, using the Black-Scholes option pricing model with the following weighted-average assumptions: Risk-free interest rate 0.20 % Expected volatility 82.18 % Expected term 1.33 years Expected dividend yield 0 % Expected volatility is based on the historical volatility of the Company’s Common Stock since its IPO in July 2013. The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2020 and December 31, 2019: Fair Value Measurement as of: March 31, 2020 December 31, 2019 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ 176,000 $ — $ — $ 176,000 $ 113,000 $ — $ — $ 113,000 Non-tradable warrants liability — — — — — — — — Total $ 176,000 $ — $ — $ 176,000 $ 113,000 $ — $ — $ 113,000 There were no transfers between Level 1 and Level 2 in any of the periods reported. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation The 2007 Equity Compensation Plan as amended (the “2007 Plan”), amended, restated and renamed the Company’s 1999 Stock Based Compensation Plan (the “1999 Plan”), which provided for the granting of incentive and nonqualified stock options and restricted stock to its employees, directors and consultants at the discretion of the board of directors. The 2013 Equity Compensation Plan (the “2013 Plan”), amended, restated and renamed the 2007 Plan. Under the 2013 Plan, the Company may grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, deferred share awards, performance awards and other equity-based awards to employees, directors and consultants. The Company initially reserved 40,718 shares of Common Stock for issuance, subject to adjustment as set forth in the 2013 Plan. The 2013 Plan included an evergreen provision, pursuant to which the maximum aggregate number of shares that may be issued under the 2013 Plan is increased on the first day of each fiscal year by the lesser of (a) a number of shares equal to four percent (4%) of the issued and outstanding Common Stock of the Company, without duplication, (b) 13,333 shares and (c) such lesser number as determined by the Company’s board of directors, subject to specified limitations. The 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”) was unanimously approved by the Company’s Board of Directors on May 24, 2018 and was approved by the Company’s stockholders on June 27, 2018. The 2018 Plan replaces the 2013 Plan. Upon stockholders’ approval of the 2018 Plan, no further awards will be made under the 2013 Plan. Awards granted under the 2013 Plan will continue in effect in accordance with the terms of the applicable award agreement and the terms of the 2013 Plan in effect when the awards were granted. Under the 2018 Plan, the Company may grant incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors and consultants, and advisors. The maximum aggregate number of shares of the Company’s common stock that may be issued under the 2018 Plan is 402,354, which is equal to the sum of (i) 400,000 shares of the Company’s common stock, plus (ii) 2,354 shares, which is the number of shares of the Company common stock reserved for issuance under the 2013 Plan that remained available as of the effective date of the 2018 Plan. In addition, the number of shares of common stock subject to outstanding awards under the 2013 Plan that terminate, expire, or are cancelled, forfeited, exchanged, or surrendered without having been exercised, vested, or paid in shares under the 2013 Plan after the effective date of the 2018 Plan will be available for issuance under the 2018 Plan. The 2018 Plan was amended following unanimous approval of the Company’s Board of Directors on April 24, 2019 and was approved by the Company’s shareholders on June 17, 2019. The amended 2018 Plan (the “Amended Plan”) allowed for an additional 589,500 shares of the Company’s common stock that may be issued under the Amended Plan with respect to awards made on and after June 17, 2019. At March 31, 2020, there were 36,791 shares available for future issuance. Stock-based compensation expense includes stock options granted to employees and non-employees and has been reported in the Company’s statements of operations and comprehensive loss in either research and development expenses or general and administrative expenses depending on the function performed by the optionee. No net tax benefits related to the stock-based compensation costs have been recognized since the Company’s inception. The Company recognized stock-based compensation expense as follows for the three ended March 31, 2020 and 2019: Three Months ended March 31, 2020 2019 General and administrative $ 45,000 $ 538,000 Research and development 48,000 112,000 $ 93,000 $ 650,000 A summary of stock option activity for the three months ended March 31, 2020 is as follows: Options Outstanding Weighted Weighted- Average Shares Average Remaining Aggregate Available Number of Exercise Contractual Intrinsic for Grant Shares Price Term (in years) Value Balance, December 31, 2019 59,731 994,453 $ 27.37 9.32 $ 0 Authorized — — Granted (34,750) 34,750 $ 0.303 10.00 Exercised — — $ — Forfeitures 11,810 (11,810) $ 29.99 1.77 Balance, March 31, 2020 36,791 1,017,393 $ 25.22 9.12 $ 0 Vested or expected to vest, March 31, 2020 985,933 $ 95.98 7.81 $ 0 Exercisable at March 31, 2020 257,495 $ 95.98 7.81 $ 0 Information with respect to stock options outstanding and exercisable at March 31, 2020 is as follows: Exercise Price Shares Exercisable $0.30 - $0.31 — $3.39 – $3.72 51,998 7,000 $4.34 – $7.05 269,913 187,500 $16.35 – $97.50 48,133 45,410 $222.00 - $225.00 1,871 1,871 $348.00 – $597.00 4,867 4,866 $651.00 – $1,129.50 3,616 3,603 $1,992.00 - $2,268.00 6,910 6,910 $4,156.50 - $4,371.00 335 335 1,017,393 257,495 The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s Common Stock, assumptions related to the expected price volatility of the Common Stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s stock. As of March 31, 2020, there was $613,000 of unrecognized compensation expense related to the unvested stock options issued from April 24, 2013 through March 31, 2020, which is expected to be recognized over a weighted-average period of approximately 2.32 years. The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following: Three Months ended March 31, 2020 2019 Risk-free interest rate 0.46 % % Expected volatility 105.30 % % Expected term 6.00 years 5.85 years Expected dividend yield 0 % % Weighted average grant date fair value $ 0.24 $ The weighted-average valuation assumptions were determined as follows: · Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. · Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin (SAB) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. · Expected stock price volatility: Expected volatility is based on the historical volatility of the Company’s Common Stock since its IPO in July 2013. · Expected annual dividend yield: The Company has never paid, and does not expect to pay, dividends in the foreseeable future. Accordingly, the Company assumed an expected dividend yield of 0.0%. · Expected Forfeiture rate: The Company’s estimated annual forfeiture rate on stock option grants was 4.14% in 2020 and 2019, based on the historical forfeiture experience. |
Research Agreements
Research Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Research Agreements | |
Research Agreements | 9. Research Agreements The Company has entered into various licensing and right-to-sublicense agreements with educational institutions for the exclusive use of patents and patent applications, as well as any patents that may develop from research being conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University (“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty payments. As no sales had been generated through March 31, 2020 under the licensed patents, the Company has not incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple a percentage of any sublicensing fees received by the Company. |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2020 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 10. License and Collaboration Agreement HanX Rigosertib Agreement (terminated) On May 10, 2019, the Company entered into a License and Collaboration Agreement (the “HanX License Agreement”) with HanX and two Securities Purchase Agreements (the “HanX Securities Purchase Agreements”), one with HanX and the other with an affiliate of HanX. Under the terms of the HanX License Agreement, the Company granted HanX an exclusive, royalty-bearing license, with the right to sublicense, to study and commercialize rigosertib in greater China (the “HanX Territory,” including the People’s Republic of China, Hong Kong, Macau and Taiwan). In exchange for these rights, the agreement required HanX to make upfront payments to the Company totaling $4 million, including a $2.0 million upfront fee and an investment totaling $2.0 million to purchase shares of the Company at a premium to market. HanX was also required to dedicate $2.0 million in local currency, to be placed in escrow, for clinical development expenses in the HanX Territory. In addition, the agreement provided for potential payments to the Company for regulatory, development and sales-based milestone payments up to $45.5 million and tiered royalties up to double digits on net sales in in the HanX Territory. The Company would supply rigosertib for sale in the HanX Territory. The HanX License Agreement also contained certain provisions for termination by either party in the event of breach of the HanX License Agreement by the other party, subject to a cure period, or bankruptcy of the other party. Under the terms of the HanX Securities Purchase Agreement, HanX and its affiliate agreed to make upfront equity investments in the Company at a specified premium to the Company’s share price. The common stock purchased by HanX and its affiliates is subject to certain lock-up restrictions and HanX and its affiliates are entitled to certain registration and participation rights. The Company assessed the HanX License Agreement for revenue recognition in accordance with ASC 606 and determined that there are two distinct performance obligations: the license and the supply of rigosertib for sale in the HanX Territory. The Company concluded that control of the license had been transferred to HanX during the three months ended June 30, 2019 and recognized license revenue of $1.7 million, which is net of applicable taxes withheld by the Chinese government, related to the $2.0 million upfront fee. The Company believes a portion of the tax being withheld by the Chinese government may be recoverable at a later date and could be recognized as license revenue if and when recovered by the Company. The $1.7 million was recorded as a receivable at June 30, 2019 and the payment was received in August 2019. Pursuant to the HanX Securities Purchase Agreements, closing of one of the upfront equity investments occurred on May 15, 2019 when an affiliate of HanX purchased 103,520 shares of common stock for $0.5 million. The total amount of the premium was $0.1 million and this amount was recognized as license revenue during the three months ended June 30, 2019. On July 9, 2019, the Company extended the deadline for payments under the HanX License Agreement and the HanX Securities Purchase Agreements. On August 8, 2019 Onconova received the non-refundable license fee from HanX. On August 14, 2019, the Company further extended the deadline of HanX's remaining upfront payments relating to its equity investment in the Company while HanX continued to seek Chinese regulatory approval for such equity investment. In December 2019, the Company reassessed the likelihood of receiving the $0.2 million premium on the equity investment previously recorded as revenue. The Company reversed the $0.2 million revenue in December 2019. On January 16, 2020, the Company determined HanX did not fulfill its obligations under the License Agreement and, in accordance with the terms of the License Agreement, the License Agreement was deemed to be void ab initio. Upon this termination, the rights to Product in the Territory reverted to the Company in accordance with the terms of the License Agreement. In addition, the Securities Purchase Agreements terminated automatically effective upon the termination of the License Agreement in accordance with the Securities Purchase Agreements. |
Related-Party Transactions
Related-Party Transactions | 3 Months Ended |
Mar. 31, 2020 | |
Related-Party Transactions | |
Related-Party Transactions | 11. Related-Party Transactions The Company has entered into a research agreement, as subsequently amended, with the Mount Sinai School of Medicine (“Mount Sinai”), with which a member of its board of directors and a stockholder is affiliated. Mount Sinai is undertaking research on behalf of the Company on the terms set forth in the agreements. Mount Sinai, in collaboration with the Company, will prepare applications for patents generated from the research. Results from all projects will belong exclusively to Mount Sinai, but the Company will have an exclusive option to license any inventions, resulting therefrom. Payments to Mount Sinai under this research agreement for the three months ended March 31, 2020 and 2019 were $124,000 and $88,000, respectively. At March 31, 2020 and December 31, 2019, the Company had $124,000 and $150,000, respectively, payable to Mount Sinai under this agreement. The Company has entered into a consulting agreement with a member of its board of directors. The board member provides consulting services to the Company on the terms set forth in the agreement. Payments to this board member for both the three months ended March 31, 2020 and 2019 were $33,000. At both March 31, 2020 and December 31, 2019, the Company had $33,000 payable under this agreement. |
Securities Registrations and Sa
Securities Registrations and Sales Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Securities Registrations and Sales Agreements | |
Securities Registrations and Sales Agreements | 12. Securities Registrations and Sales Agreements January 2020 Offering On December 31, 2019, the Company entered into definitive securities purchase agreements with institutional investors for the issuance and sale in a registered direct offering of 27,662,518 shares of the Company's common stock at an offering price of $0.3615 per share. Pursuant to the December 2019 HCW Engagement Letter, HCW agreed to serve as exclusive placement agent for the offering. In connection with the offering, the Company paid HCW an aggregate cash fee equal to 7.0% of the gross proceeds in the offering, management fee equal to 1.0% of the gross proceeds raised in the offering, $85,000 for non-accountable expenses; and $10,000 for clearing fees. The Company also issued to HCW or its designees placement agent warrant to purchase up to 1,383,126 shares of common stock at an exercise price of $0.4519 per share. The placement agent warrants are immediately exercisable and will expire on December 31, 2023. The net proceeds to the Company from the offering, after deducting HCW's placement agent fees and expenses and other estimated offering expenses payable by the Company were approximately $9.0 million and were received in January 2020. The offering was pursuant to a prospectus dated December 28, 2017, and a prospectus supplement dated as of December 31, 2019 to be filed in connection with a takedown from the Company's shelf registration statement on Form S-3 (File No. 333-221684). The offering closed on January 3, 2020. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiary, Onconova Europe GmbH. All significant intercompany transactions have been eliminated. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2020 and 2019, the consolidated statements of stockholders’ equity (deficit) for the three months ended March 31, 2020 and 2019 and the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2020, the results of its operations for the three months ended March 31, 2020 and 2019, and its cash flows for the three months ended March 31, 2020 and 2019. The financial data and other information disclosed in these notes related to the three months ended March 31, 2020 and 2019 are unaudited. The results for the three months ended March 31, 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2019 included in the Company’s annual report on Form 10-K filed with the SEC on March 27, 2020. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2019 included in the Company’s annual report on Form 10-K filed with the SEC on March 27, 2020. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. |
Fair Value Measurements | Fair Value Measurements The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the warrant liability is discussed in Note 7, “Fair Value Measurements.” |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted effective January 1, 2018 using the modified retrospective method. There was no material impact to our financial position and results of operations as a result of the adoption. The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company derives revenue from collaboration and licensing agreements and from the sale of products associated with material transfer, collaboration and supply agreements. License, Collaboration and Other Revenues The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success. Licensing of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees 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 performance obligations, 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 and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : At the inception of each arrangement that includes development milestone payments, 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 will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development 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 revenues and earnings in their period of adjustment. Manufacturing supply services. Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment. Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements. |
Leases | Leases The Company accounts for leases in accordance with Accounting Standards Codification Topic 842, Leases (ASC 842), which the Company adopted effective January 1, 2019. The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Right of Use (ROU) Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short term leases (term of 12 months or less) on the balance sheet, and not separating lease and non-lease components. At January 1, 2019 and March 31, 2020 the Company had one lease, which was for office space. The lease qualifies for the short term lease exception. Consequently, no ROU Asset or Lease Liability was recorded. The lease payments are being recognized as an expense on a straight-line basis over the lease term. Lease payments for the three months ended March 31, 2020 were $45,000. Remaining payments due under the lease at March 31, 2020 are $166,000. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016 and through subsequent amendments, the FASB issued guidance which supersedes much of the previous guidance for leases. The new guidance requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all the leases with terms greater than twelve months. Based on certain criteria, leases are classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. The guidance was effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors were permitted to recognize and measure leases at the date of adoption using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of the new guidance, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. The Company adopted the guidance in ASC 842 effective January 1, 2019 using the modified retrospective method, which does not require the restatement of prior period amounts. There was no impact to the Company’s financial position and results of operations as a result of the adoption. In August 2018, the FASB issued guidance which changes the disclosure requirements for fair value measurement. The guidance amends the disclosure requirements in ASC Topic 820 by adding, changing, or removing certain disclosures. The guidance is effective for fiscal years beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020. There was no impact to the Company’s financial position, results of operations or financial statement disclosures as a result of the adoption. In November 2018, the FASB issued guidance, which clarifies the interaction between ASC Topic 808, Collaborative Arrangements , and ASC Topic 606, Revenue from Contracts with Customers . The guidance, among other items, clarifies that certain transactions between collaborative participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. The guidance is effective for fiscal years beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020. There was no impact to the Company’s financial position and results of operations as a result of the adoption. In June 2016, the FASB issued new guidance on the accounting for credit losses on financial instruments. The guidance was amended in November 2019. The new guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The guidance is effective for fiscal years beginning after December 15, 2022, and interim periods within those years, with early adoption permitted. The Company is evaluating the impact of the adoption of the standard on its consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Revenue. | |
Schedule of recognized revenue under funding, license and collaboration agreements | Three Months Ended March 31, 2020 2019 Symbio Upfront license fee recognition over time $ 56,000 $ 57,000 Supplies and other (4,000) 11,000 $ 52,000 $ 68,000 |
Schedule of deferred revenue | Symbio Upfront Payment Deferred balance at December 31, 2019 $ 3,921,000 Recognition to revenue 56,000 Deferred balance at March 31, 2020 $ 3,865,000 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Net Loss Per Share of Common Stock | |
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | March 31, 2020 2019 Warrants 27,373,567 5,504,722 Stock options 1,017,393 345,794 28,390,960 5,850,516 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Warrants | |
Schedule of warrants outstanding and warrant activity | Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants March 31, Description Classification Price Date 2019 Issued / Amended Exercised Expired/ Amended 2020 Non-tradable warrants Liability $ 172.50 July 2021 6,456 — — — 6,456 Tradable warrants Liability $ 73.80 July 2021 212,801 — — — 212,801 Non-tradable pre-funded warrants Equity $ 0.15 July 2023 394 — — — 394 Non-tradable warrants Equity $ 1.60 December 2022 392,834 — — — 392,834 Non-tradable warrants Equity $ 14.10 March 2021 5,000 — — — 5,000 Non-tradable warrants Equity $ 21.15 March 2021 8,333 — — — 8,333 Non-tradable warrants Equity $ 7.7895 June 2021 15,000 — — — 15,000 Non-tradable pre-funded warrants Equity $ 0.15 none 52,834 — — — 52,834 Non-tradable warrants Equity $ 1.600 December 2022 1,806,104 — — — 1,806,104 Non-tradable pre-funded warrants Equity $ 0.15 none 74,617 — — — 74,617 Non-tradable warrants Equity $ 2.00 September 2023 109,585 — — — 109,585 Non-tradable pre-funded warrants Equity $ 0.0001 none 1,250,000 — — — 1,250,000 Non-tradable warrants Equity $ 0.20 November 2024 41,037,000 — (28,586,200) — 12,450,800 Non-tradable warrants Equity $ 0.250 November 2024 2,521,875 — — — 2,521,875 Non-tradable warrants Equity $ 0.287 December 2024 3,581,662 — — — 3,581,662 Non-tradable warrants Equity $ 0.43625 December 2024 716,332 — — — 716,332 Non-tradable warrants Equity $ 0.298 December 2024 3,469,716 — — — 3,469,716 Non-tradable warrants Equity $ 0.45030 December 2024 693,943 — — — 693,943 Non-tradable warrants Equity $ 0.45190 December 2023 — 1,383,126 — — 1,383,126 55,954,486 1,383,126 (28,586,200) — 28,751,412 |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Balance Sheet Detail | |
Schedule of prepaid expenses and other current assets | March 31, December 31, 2020 2019 Research and development $ 366,000 $ 321,000 Manufacturing 39,000 25,000 Insurance 168,000 164,000 Other 222,000 140,000 $ 795,000 $ 650,000 |
Schedule of property and equipment | March 31, December 31, 2020 2019 Property and equipment $ 2,283,000 $ 2,283,000 Accumulated depreciation (2,236,000) (2,233,000) $ 47,000 $ 50,000 |
Schedule of accrued expenses and other current liabilities | March 31, December 31, 2020 2019 Research and development $ 1,863,000 $ 2,016,000 Employee compensation 526,000 1,537,000 Professional fees 112,000 242,000 $ 2,501,000 $ 3,795,000 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Measurements | |
Schedule of Black-Scholes option pricing model assumptions | Risk-free interest rate 0.20 % Expected volatility 82.18 % Expected term 1.33 years Expected dividend yield 0 % |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | Fair Value Measurement as of: March 31, 2020 December 31, 2019 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ 176,000 $ — $ — $ 176,000 $ 113,000 $ — $ — $ 113,000 Non-tradable warrants liability — — — — — — — — Total $ 176,000 $ — $ — $ 176,000 $ 113,000 $ — $ — $ 113,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three Months ended March 31, 2020 2019 General and administrative $ 45,000 $ 538,000 Research and development 48,000 112,000 $ 93,000 $ 650,000 |
Schedule of stock option activity | Options Outstanding Weighted Weighted- Average Shares Average Remaining Aggregate Available Number of Exercise Contractual Intrinsic for Grant Shares Price Term (in years) Value Balance, December 31, 2019 59,731 994,453 $ 27.37 9.32 $ 0 Authorized — — Granted (34,750) 34,750 $ 0.303 10.00 Exercised — — $ — Forfeitures 11,810 (11,810) $ 29.99 1.77 Balance, March 31, 2020 36,791 1,017,393 $ 25.22 9.12 $ 0 Vested or expected to vest, March 31, 2020 985,933 $ 95.98 7.81 $ 0 Exercisable at March 31, 2020 257,495 $ 95.98 7.81 $ 0 |
Schedule of information with respect to stock options outstanding and exercisable | Information with respect to stock options outstanding and exercisable at March 31, 2020 is as follows: Exercise Price Shares Exercisable $0.30 - $0.31 — $3.39 – $3.72 51,998 7,000 $4.34 – $7.05 269,913 187,500 $16.35 – $97.50 48,133 45,410 $222.00 - $225.00 1,871 1,871 $348.00 – $597.00 4,867 4,866 $651.00 – $1,129.50 3,616 3,603 $1,992.00 - $2,268.00 6,910 6,910 $4,156.50 - $4,371.00 335 335 1,017,393 257,495 |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Three Months ended March 31, 2020 2019 Risk-free interest rate 0.46 % % Expected volatility 105.30 % % Expected term 6.00 years 5.85 years Expected dividend yield 0 % % Weighted average grant date fair value $ 0.24 $ |
Nature of Business - Liquidity
Nature of Business - Liquidity (Details) | Jan. 03, 2020USD ($)shares | Dec. 19, 2019USD ($)shares | Dec. 10, 2019USD ($)shares | Sep. 25, 2019USD ($)shares | Jul. 29, 2016shares | Jan. 05, 2016$ / sharesshares | Nov. 30, 2019USD ($)shares | Mar. 31, 2020USD ($)shares | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($) |
Liquidity | |||||||||||
Net loss | $ (5,092,000) | $ (7,600,000) | |||||||||
Accumulated deficit | 408,491,000 | $ 403,399,000 | |||||||||
Cash and cash equivalents | $ 31,036,000 | 10,396,000 | $ 22,726,000 | $ 16,970,000 | |||||||
Common stock outstanding (in shares) | shares | 167,416,070 | 111,167,352 | |||||||||
Proceeds from the sale of common stock and warrants, net of costs | $ 9,000,000 | $ 4,400,000 | $ 4,400,000 | $ 3,300,000 | $ 9,700,000 | $ 9,062,000 | |||||
Proceeds from the exercise of warrants | $ 5,717,000 | $ 33,000 | $ 4,900,000 | ||||||||
Proceeds from the exercise of pre-funded warrants | $ 35,000 | ||||||||||
Issuance of common stock, net (in shares) | shares | 27,662,518 | 13,878,864 | 14,326,648 | 2,198,938 | 239,986 | 12,912 | 30,250,000 | ||||
Stock called by warrants or rights | shares | 6,939,432 | 7,163,324 | 2,198,938 | 6,456 | 55,000,000 | 28,586,200 | |||||
Price per share (in dollars per share) | $ / shares | $ 142.50 | ||||||||||
FTE positions eliminated | 6 | ||||||||||
FTE eliminated positions (as percent of workforce) | 24.00% | ||||||||||
Severance charge | $ 1,843,000 | ||||||||||
Non-cash charge, accelerated options | 415,000 | ||||||||||
General and administrative | |||||||||||
Liquidity | |||||||||||
Severance charge | 1,562,000 | ||||||||||
Research and development | |||||||||||
Liquidity | |||||||||||
Severance charge | $ 281,000 | ||||||||||
Pre-funded warrants | |||||||||||
Liquidity | |||||||||||
Stock called by warrants or rights | shares | 24,750,000 | 23,720,784 | |||||||||
Warrants | |||||||||||
Liquidity | |||||||||||
Stock called by warrants or rights | shares | 21,014,378 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Segment Information (Details) | 3 Months Ended |
Mar. 31, 2020segment | |
Summary of Significant Accounting Policies | |
Number of operating segments | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Leases (Details) | Jan. 01, 2019USD ($) | Mar. 31, 2020USD ($) |
Summary of Significant Accounting Policies | ||
Number of leases | 1 | 1 |
Amount of lease payments | $ 45,000 | |
Remaining payments due | 166,000 | |
Amount of lease liabilities | $ 0 | 0 |
Amount of right of use asset | $ 0 | $ 0 |
Revenue (Details)
Revenue (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue | ||
Revenue | $ 52,000 | $ 68,000 |
Deferred revenue | ||
Balance at the beginning of the period | 226,000 | |
Balance at the end of the period | 226,000 | |
SymBio | ||
Deferred revenue | ||
Balance at the beginning of the period | 3,921,000 | |
Recognition to revenue | 56,000 | |
Balance at the end of the period | 3,865,000 | |
License and collaboration agreements | ||
Revenue | ||
Revenue | 52,000 | 68,000 |
License and collaboration agreements | SymBio | Upfront license fee recognition over time | ||
Revenue | ||
Revenue | 56,000 | 57,000 |
License and collaboration agreements | SymBio | Supplies and other | ||
Revenue | ||
Revenue | $ (4,000) | $ 11,000 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares as they would be antidilutive | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares | 28,390,960 | 5,850,516 |
Warrants | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares as they would be antidilutive | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares | 27,373,567 | 5,504,722 |
Stock options | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares as they would be antidilutive | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares | 1,017,393 | 345,794 |
Warrants (Details)
Warrants (Details) - $ / shares | Jan. 03, 2020 | Dec. 31, 2019 | Dec. 19, 2019 | Dec. 10, 2019 | Sep. 25, 2019 | Jul. 29, 2016 | Jan. 05, 2016 | Nov. 30, 2019 | Mar. 31, 2020 |
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 73.80 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 55,954,486 | ||||||||
Warrants Issued (in shares) | 1,383,126 | ||||||||
Warrants Exercised (in shares) | (28,586,200) | ||||||||
Balance at end of the period (in shares) | 55,954,486 | 28,751,412 | |||||||
Common Stock authorized (in shares) | 250,000,000 | 250,000,000 | |||||||
Issuance of stock (in shares) | 27,662,518 | 13,878,864 | 14,326,648 | 2,198,938 | 239,986 | 12,912 | 30,250,000 | ||
Non-tradable warrants with exercise price 172.50 Liability | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 172.50 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 6,456 | ||||||||
Balance at end of the period (in shares) | 6,456 | 6,456 | |||||||
Tradable warrants with exercise price 73.80 Liability | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 73.80 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 212,801 | ||||||||
Balance at end of the period (in shares) | 212,801 | 212,801 | |||||||
Non-tradable warrants with exercise price 0.15 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.15 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 394 | ||||||||
Balance at end of the period (in shares) | 394 | 394 | |||||||
Non-tradable warrants with exercise price 1.60 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 1.60000 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 392,834 | ||||||||
Balance at end of the period (in shares) | 392,834 | 392,834 | |||||||
Non-tradable warrants with exercise price 14.10 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 14.10 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 5,000 | ||||||||
Balance at end of the period (in shares) | 5,000 | 5,000 | |||||||
Non-tradable warrants with exercise price 21.15 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 21.15000 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 8,333 | ||||||||
Balance at end of the period (in shares) | 8,333 | 8,333 | |||||||
Non-tradable warrants with exercise price 7.7895 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 7.7895 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 15,000 | ||||||||
Balance at end of the period (in shares) | 15,000 | 15,000 | |||||||
Non-tradable pre-funded warrants with exercise Price 0.15 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.15 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 52,834 | ||||||||
Balance at end of the period (in shares) | 52,834 | 52,834 | |||||||
Non-tradable warrants with exercise price 1.6000 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 1.600 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 1,806,104 | ||||||||
Balance at end of the period (in shares) | 1,806,104 | 1,806,104 | |||||||
Non-tradable pre-funded warrants with exercise Price 0.15 Equity1 | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.1500 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 74,617 | ||||||||
Balance at end of the period (in shares) | 74,617 | 74,617 | |||||||
Non-tradable warrants with exercise price 2.00 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 2 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 109,585 | ||||||||
Balance at end of the period (in shares) | 109,585 | 109,585 | |||||||
Non-tradable pre-funded warrants with exercise Price 0.0001 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.0001 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 1,250,000 | ||||||||
Balance at end of the period (in shares) | 1,250,000 | 1,250,000 | |||||||
Non-tradable warrants with exercise price 0.20 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.200 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 41,037,000 | ||||||||
Warrants Exercised (in shares) | (28,586,200) | ||||||||
Balance at end of the period (in shares) | 41,037,000 | 12,450,800 | |||||||
Non-tradable warrants with exercise price 0.250 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.250 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 2,521,875 | ||||||||
Balance at end of the period (in shares) | 2,521,875 | 2,521,875 | |||||||
Non-tradable warrants with exercise price 0.287 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.287 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 3,581,662 | ||||||||
Balance at end of the period (in shares) | 3,581,662 | 3,581,662 | |||||||
Non-tradable warrants with exercise price 0.43625 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.43625 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 716,332 | ||||||||
Balance at end of the period (in shares) | 716,332 | 716,332 | |||||||
Non-tradable warrants with exercise price 0.298 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.298 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 3,469,716 | ||||||||
Balance at end of the period (in shares) | 3,469,716 | 3,469,716 | |||||||
Non-tradable warrants with exercise price 0.45030 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.45030 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Balance at beginning of the period (in shares) | 693,943 | ||||||||
Balance at end of the period (in shares) | 693,943 | 693,943 | |||||||
Non-tradable Warrants with Exercise Price 0.45190 Equity | |||||||||
Warrants | |||||||||
Warrant exercise price (in dollars per share) | $ 0.45190 | ||||||||
Warrants outstanding and warrant activity | |||||||||
Warrants Issued (in shares) | 1,383,126 | ||||||||
Balance at end of the period (in shares) | 1,383,126 |
Balance Sheet Detail - Prepaid
Balance Sheet Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Prepaid expenses and other current assets: | ||
Research and development | $ 366,000 | $ 321,000 |
Manufacturing | 39,000 | 25,000 |
Insurance | 168,000 | 164,000 |
Other | 222,000 | 140,000 |
Prepaid expenses and other current assets | $ 795,000 | $ 650,000 |
Balance Sheet Detail Property a
Balance Sheet Detail Property and Equipment (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Property and Equipment | ||
Property and equipment | $ 2,283,000 | $ 2,283,000 |
Accumulated depreciation | (2,236,000) | (2,233,000) |
Property and equipment, net | $ 47,000 | $ 50,000 |
Balance Sheet Detail - Accrued
Balance Sheet Detail - Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Detail | ||
Research and development | $ 1,863,000 | $ 2,016,000 |
Employee compensation | 526,000 | 1,537,000 |
Professional fees | 112,000 | 242,000 |
Accrued expenses and other current liabilities: | $ 2,501,000 | $ 3,795,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Jan. 03, 2020 | Dec. 19, 2019 | Dec. 10, 2019 | Sep. 25, 2019 | Jul. 29, 2016 | Jan. 05, 2016 | Nov. 30, 2019 | Mar. 31, 2020 | Dec. 31, 2019 |
Sale of Securities | |||||||||
Issuance of common stock, net (in shares) | 27,662,518 | 13,878,864 | 14,326,648 | 2,198,938 | 239,986 | 12,912 | 30,250,000 | ||
Price per share (in dollars per share) | $ 142.50 | ||||||||
Stock called by warrants or rights | 6,939,432 | 7,163,324 | 2,198,938 | 6,456 | 55,000,000 | 28,586,200 | |||
ProceedsFromIssuanceOrSaleOfEquity | $ 1,840,000 | ||||||||
Estimated fair value using the Black-Scholes pricing model | $ 0 | $ 0 |
Fair Value Measurements - Right
Fair Value Measurements - Rights Offering (Details) - $ / shares | Jan. 03, 2020 | Dec. 19, 2019 | Dec. 10, 2019 | Sep. 25, 2019 | Jul. 29, 2016 | Jan. 05, 2016 | Nov. 30, 2019 |
Subsidiary, Sale of Stock [Line Items] | |||||||
Issuance of common stock, net (in shares) | 27,662,518 | 13,878,864 | 14,326,648 | 2,198,938 | 239,986 | 12,912 | 30,250,000 |
Rights or warrants issued (in shares) | 212,801 | ||||||
Exercise price (in dollars per share) | $ 73.80 | ||||||
Class Of Warrant Or Right Initially Exercisable Term | 5 years | ||||||
Redemption period (in years) | 1 year | ||||||
Redemption price (in dollars per share) | $ 0.001 | ||||||
Volume weighted average price per share of common stock (in dollars per share) | $ 184.50 | ||||||
Threshold consecutive trading days (in days) | 10 days | ||||||
Pre-funded warrants | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Rights or warrants issued (in shares) | 43,760 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted-average assumptions (Details) | Mar. 31, 2020Y |
Risk-free interest rate | Pre-funded warrants | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0.20 |
Expected volatility | Pre-funded warrants | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 82.18 |
Expected term | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 1.33 |
Expected dividend yield | Pre-funded warrants | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Measurement input | 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy Table (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Liabilities measured at fair value | ||
Warrant liability | $ 176,000 | $ 113,000 |
Recurring basis | ||
Liabilities measured at fair value | ||
Total | 176,000 | 113,000 |
Recurring basis | Tradable warrants liability | ||
Liabilities measured at fair value | ||
Warrant liability | 176,000 | 113,000 |
Recurring basis | Level 1 | ||
Liabilities measured at fair value | ||
Total | 176,000 | 113,000 |
Recurring basis | Level 1 | Tradable warrants liability | ||
Liabilities measured at fair value | ||
Warrant liability | $ 176,000 | $ 113,000 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers (Details) | Mar. 31, 2020USD ($) |
Fair Value Measurements | |
Amount of transfers of assets out of Level 1 into Level 2 | $ 0 |
Amount of transfers of assets out of Level 2 into Level 1 | 0 |
Amount of transfers of liabilities out of Level 1 into Level 2 | 0 |
Amount of transfers of liabilities out of Level 2 into Level 1 | $ 0 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | Jun. 17, 2019 | Mar. 31, 2020 | Dec. 31, 2018 | Jun. 27, 2018 | Jul. 31, 2013 |
2013 Plan | |||||
Stock-Based Compensation | |||||
Shares authorized (in shares) | 40,718 | ||||
Evergreen provision (percent) | 4.00% | ||||
Evergreen provision, shares ( in shares) | 13,333 | ||||
2013 Plan | Common Stock | |||||
Stock-Based Compensation | |||||
Shares authorized (in shares) | 2,354 | ||||
2018 Plan | |||||
Stock-Based Compensation | |||||
Shares authorized (in shares) | 402,354 | ||||
Additional shares authorized (in shares) | 589,500 | ||||
2018 Plan | Common Stock | |||||
Stock-Based Compensation | |||||
Shares authorized (in shares) | 400,000 | ||||
Stock options | |||||
Stock-Based Compensation | |||||
Common Stock available for future issuance (in shares) | 36,791 | 59,731 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Stock-Based Compensation | ||
Net tax benefits related to the stock-based compensation costs | $ 0 | |
Total stock-based compensation | 93,000 | $ 650,000 |
General and administrative | ||
Stock-Based Compensation | ||
Total stock-based compensation | 45,000 | 538,000 |
Research and development | ||
Stock-Based Compensation | ||
Total stock-based compensation | $ 48,000 | $ 112,000 |
Stock-Based Compensation - Acti
Stock-Based Compensation - Activity (Details) - Stock options - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2018 | |
Shares Available for Grant | ||
Granted (in shares) | 34,750 | |
Cancelled (in shares) | (11,810) | |
Balance at the end of the period (in shares) | 36,791 | 59,731 |
Number of Shares | ||
Granted (in shares) | 34,750 | |
Forfeitures (in shares) | (11,810) | |
Cancelled (in shares) | (11,810) | |
Balance at the end of the period (in shares) | 1,017,393 | 994,453 |
Vested or expected to vest at the end of the period (in shares) | 985,933 | |
Exercisable at the end of the period (in shares) | 257,495 | |
Weighted-Average Exercise Price | ||
Granted (in dollars per share) | $ 0.303 | |
Forfeitures (in dollars per share) | 29.99 | |
Balance at the end of the period (in dollars per share) | 25.22 | $ 27.37 |
Vested or expected to vest at the end of the period (in dollars per share) | 95.98 | |
Exercisable at the end of the period (in dollars per share) | $ 95.98 | |
Additional Disclosures | ||
Weighted average remaining contractual term | 9 years 1 month 13 days | 9 years 3 months 26 days |
Weighted average remaining contractual term of options forfeitures | 1 year 9 months 7 days | |
Weighted average remaining contractual term of options granted | 10 years | |
Weighted average remaining contractual term of options vested or expected to vest | 7 years 9 months 22 days | |
Weighted average remaining contractual term of options exercisable | 7 years 9 months 22 days | |
Aggregate intrinsic value of options outstanding | $ 0 | $ 0 |
Aggregate intrinsic value of options vested or expected to vest | 0 | |
Aggregate intrinsic value of options exercisable | $ 0 |
Stock-Based Compensation - Outs
Stock-Based Compensation - Outstanding and Exercisable (Details) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Stock options | |
Share-Based Compensation | |
Shares (in shares) | 1,017,393 |
Exercisable (in shares) | 257,495 |
Exercise Price Range $0.30 - $0.31 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 0.30 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 0.31 |
Shares (in shares) | 629,750 |
Exercise Price Range $3.39 - $3.72 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 3.39 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 3.72 |
Shares (in shares) | 51,998 |
Exercisable (in shares) | 7,000 |
Exercise Price Range $4.34 - $7.05 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 4.34 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 7.05 |
Shares (in shares) | 269,913 |
Exercisable (in shares) | 187,500 |
Exercise Price Range $16.35 - $97.50 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 16.35 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 97.50 |
Shares (in shares) | 48,133 |
Exercisable (in shares) | 45,410 |
Exercise Price Range $222.00 - $225.00 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 222 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 225 |
Shares (in shares) | 1,871 |
Exercisable (in shares) | 1,871 |
Exercise Price Range $348.00 - $597.00 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 348 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 597 |
Shares (in shares) | 4,867 |
Exercisable (in shares) | 4,866 |
Exercise Price Range $651.00 - $1,129.50 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 651 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 1,129.50 |
Shares (in shares) | 3,616 |
Exercisable (in shares) | 3,603 |
Exercise Price Range $1,992.00 - $2,268.00 | Stock options | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 1,992 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 2,268 |
Shares (in shares) | 6,910 |
Exercisable (in shares) | 6,910 |
Exercise Price Range $4,156.50 - $4,371.00 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 4,156.50 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 4,371 |
Exercise Price Range $4,156.50 - $4,371.00 | Stock options | |
Share-Based Compensation | |
Shares (in shares) | 335 |
Exercisable (in shares) | 335 |
Stock-Based Compensation - Unre
Stock-Based Compensation - Unrecognized Compensation Expense (Details) - Stock options | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 613,000 |
Weighted-average period for recognizing unrecognized compensation expense related to unvested stock options (in years) | 2 years 3 months 26 days |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions (Details) - Stock options - $ / shares | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Assumptions used | ||||
Risk-free interest rate (as a percent) | 0.46% | 1.92% | ||
Expected volatility (as a percent) | 105.30% | 82.58% | ||
Expected term (in years) | 6 years | 5 years 10 months 6 days | ||
Expected dividend yield (as a percent) | 0.00% | 0.00% | ||
Weighted average grant date fair value (in dollars per share) | $ 0.24 | $ 1.81 | ||
Annualized forfeiture rate (as a percent) | 4.14% | 4.14% |
Research Agreements (Details)
Research Agreements (Details) | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Research agreements | |
Research Agreements | |
Revenue | $ 0 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | Jan. 03, 2020 | Dec. 19, 2019 | Dec. 10, 2019 | Sep. 25, 2019 | May 15, 2019 | May 10, 2019 | Jul. 29, 2016 | Jan. 05, 2016 | Dec. 31, 2019 | Nov. 30, 2019 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 |
License and collaboration agreements | |||||||||||||
Issuance of common stock, net (in shares) | 27,662,518 | 13,878,864 | 14,326,648 | 2,198,938 | 239,986 | 12,912 | 30,250,000 | ||||||
Value of common stock | $ 9,062,000 | ||||||||||||
Research and development | $ 3,370,000 | $ 4,075,000 | |||||||||||
License and collaboration agreements | HanX | |||||||||||||
License and collaboration agreements | |||||||||||||
Committed amount | $ 4,000,000 | ||||||||||||
Collaborative Arrangement upfront fees | $ 2,000,000 | ||||||||||||
Collaboration revenue | 2,000,000 | ||||||||||||
Issuance of common stock, net (in shares) | 103,520 | ||||||||||||
Escrow Deposit | 2,000,000 | ||||||||||||
Aggregate potential milestone payments based on annual net sales | 45,500,000 | ||||||||||||
Revenue | 1,700,000 | ||||||||||||
Receivable recorded | 1,700,000 | ||||||||||||
Value of common stock | $ 500,000 | $ 2,000,000 | |||||||||||
Redemption premium | $ 100,000 | $ 200,000 | |||||||||||
Reversal of revenue recognized | $ 200,000 | ||||||||||||
License and collaboration agreements | HanX | Other Current Assets [Member] | |||||||||||||
License and collaboration agreements | |||||||||||||
Receivable recorded | $ 200,000 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | |
Member of board of directors | ||||
Related-Party Transactions | ||||
Payments to related party | $ 124,000 | $ 88,000 | ||
Amounts due to related party | 124,000 | 150,000 | ||
Significant shareholder | ||||
Related-Party Transactions | ||||
Payments to related party | 33,000 | $ 33,000 | ||
Amounts due to related party | $ 33,000 | $ 33,000 | $ 33,000 |
Securities Registrations and _2
Securities Registrations and Sales Agreements - Underwriting agreement with HCW (Details) - USD ($) | Jan. 03, 2020 | Dec. 31, 2019 | Dec. 19, 2019 | Dec. 10, 2019 | Sep. 25, 2019 | Jul. 29, 2016 | Jan. 05, 2016 | Nov. 30, 2019 |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 27,662,518 | 13,878,864 | 14,326,648 | 2,198,938 | 239,986 | 12,912 | 30,250,000 | |
Warrant exercise price (in dollars per share) | $ 73.80 | |||||||
HCW | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrant exercise price (in dollars per share) | $ 0.4519 | |||||||
Percentage of cash fees on gross proceeds | 7.00% | |||||||
Percentage of management fees on gross proceeds | 1.00% | |||||||
Payment of Non-accountable Expenses | $ 85,000 | |||||||
Payment of Clearing Fees | $ 10,000 | |||||||
Warrants issued to purchase of common stock | 1,383,126 | |||||||
Proceeds from issuance of warrants | $ 9,000,000 | |||||||
The Offering | Certain institutional and accredited investors | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 27,662,518 | |||||||
The Offering | Certain institutional and accredited investors | Common Stock Warrants | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrant exercise price (in dollars per share) | $ 0.3615 |