Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 04, 2021 | |
Document and Entity Information | ||
Entity Registrant Name | Onconova Therapeutics, Inc. | |
Entity Central Index Key | 0001130598 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2021 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Interactive Data Current | Yes | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 15,781,040 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Title of 12(b) Security | Common Stock, par value $.01 per share | |
Trading Symbol | ONTX | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 22-3627252 | |
Entity File Number | 001-36020 | |
Entity Address, Address Line One | 12 Penns Trail | |
Entity Address, City or Town | Newtown | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 18940 | |
City Area Code | 267 | |
Local Phone Number | 759-3680 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 43,709,000 | $ 19,025,000 |
Receivables | 27,000 | 37,000 |
Prepaid expenses and other current assets | 457,000 | 722,000 |
Total current assets | 44,193,000 | 19,784,000 |
Property and equipment, net | 45,000 | 52,000 |
Other non-current assets | 140,000 | 150,000 |
Total assets | 44,378,000 | 19,986,000 |
Current liabilities: | ||
Accounts payable | 4,290,000 | 4,833,000 |
Accrued expenses and other current liabilities | 2,983,000 | 4,962,000 |
Deferred revenue | 226,000 | 226,000 |
Total current liabilities | 7,499,000 | 10,021,000 |
Warrant liability | 530,000 | 321,000 |
Deferred revenue, non-current | 3,356,000 | 3,469,000 |
Total liabilities | 11,385,000 | 13,811,000 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 5,000,000 authorized at June 30, 2021 and December 31, 2020, none issued and outstanding at June 30, 2021 and December 31, 2020 | ||
Common stock, $0.01 par value, 125,000,000 and 250,000,000 authorized at June 30, 2021 and December 31, 2020, 15,781,040 and 12,396,219 shares issued and outstanding at June 30, 2021 and December 31, 2020. | 158,000 | 124,000 |
Additional paid in capital | 470,335,000 | 434,593,000 |
Accumulated deficit | (437,502,000) | (428,556,000) |
Accumulated other comprehensive (loss) income | 2,000 | 14,000 |
Total stockholders' equity | 32,993,000 | 6,175,000 |
Total liabilities and stockholders' equity | $ 44,378,000 | $ 19,986,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
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 | 125,000,000 | 250,000,000 |
Common stock, shares issued | 15,781,040 | 12,396,219 |
Common stock, shares outstanding | 15,781,040 | 12,396,219 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Condensed Consolidated Statements of Operations | ||||
Revenue | $ 57,000 | $ 56,000 | $ 113,000 | $ 108,000 |
Operating expenses: | ||||
General and administrative | 2,850,000 | 2,594,000 | 5,067,000 | 4,401,000 |
Research and development | 1,852,000 | 4,801,000 | 3,789,000 | 8,171,000 |
Total operating expenses | 4,702,000 | 7,395,000 | 8,856,000 | 12,572,000 |
Loss from operations | (4,645,000) | (7,339,000) | (8,743,000) | (12,464,000) |
Change in fair value of warrant liability | 427,000 | (56,000) | (209,000) | (119,000) |
Other income, net | (13,000) | 6,000 | 96,000 | |
Net loss | $ (4,231,000) | $ (7,395,000) | $ (8,946,000) | $ (12,487,000) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.27) | $ (0.65) | $ (0.59) | $ (1.14) |
Basic and diluted weighted average shares outstanding (in shares) | 15,780,863 | 11,303,508 | 15,201,719 | 10,996,624 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (4,231,000) | $ (7,395,000) | $ (8,946,000) | $ (12,487,000) |
Other comprehensive loss, before tax: | ||||
Foreign currency translation adjustments, net | 4,000 | 7,000 | (12,000) | 1,000 |
Other comprehensive loss, net of tax | 4,000 | 7,000 | (12,000) | 1,000 |
Comprehensive loss | $ (4,227,000) | $ (7,388,000) | $ (8,958,000) | $ (12,486,000) |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive (loss) income | Total |
Balance at Dec. 31, 2019 | $ 74,000 | $ 414,917,000 | $ (403,399,000) | $ (18,000) | $ 11,574,000 |
Balance (in shares) at Dec. 31, 2019 | 7,411,157 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (12,487,000) | (12,487,000) | |||
Other comprehensive income (loss) | 1,000 | 1,000 | |||
Stock-based compensation | 185,000 | 185,000 | |||
Issuance of common stock, net | $ 18,000 | 9,044,000 | 9,062,000 | ||
Issuance of common stock, net (in shares) | 1,844,168 | ||||
Issuance of common stock upon exercise of warrants | $ 23,000 | 7,274,000 | 7,297,000 | ||
Issuance of common stock upon exercise of warrants (in shares) | 2,273,172 | ||||
Issuance of common stock, pre-funded warrants and warrants, net | $ 1,000 | 1,000 | |||
Issuance of common stock, pre-funded warrants and warrants, net (in shares) | 83,333 | ||||
Balance at Jun. 30, 2020 | $ 116,000 | 431,420,000 | (415,886,000) | (17,000) | 15,633,000 |
Balance (in shares) at Jun. 30, 2020 | 11,611,830 | ||||
Balance at Mar. 31, 2020 | $ 111,000 | 429,752,000 | (408,491,000) | (24,000) | 21,348,000 |
Balance (in shares) at Mar. 31, 2020 | 11,161,072 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (7,395,000) | (7,395,000) | |||
Other comprehensive income (loss) | 7,000 | 7,000 | |||
Stock-based compensation | 92,000 | 92,000 | |||
Issuance of common stock upon exercise of warrants | $ 4,000 | 1,576,000 | 1,580,000 | ||
Issuance of common stock upon exercise of warrants (in shares) | 367,425 | ||||
Issuance of common stock, pre-funded warrants and warrants, net | $ 1,000 | 1,000 | |||
Issuance of common stock, pre-funded warrants and warrants, net (in shares) | 83,333 | ||||
Balance at Jun. 30, 2020 | $ 116,000 | 431,420,000 | (415,886,000) | (17,000) | 15,633,000 |
Balance (in shares) at Jun. 30, 2020 | 11,611,830 | ||||
Balance at Dec. 31, 2020 | $ 124,000 | 434,593,000 | (428,556,000) | 14,000 | $ 6,175,000 |
Balance (in shares) at Dec. 31, 2020 | 12,396,219 | 12,396,219 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (8,946,000) | $ (8,946,000) | |||
Other comprehensive income (loss) | (12,000) | (12,000) | |||
Exercise of stock options | 24,000 | 24,000 | |||
Exercise of stock options (in shares) | 4,642 | ||||
Stock-based compensation | 125,000 | 125,000 | |||
Shares issued in connection with reverse stock split | 104 | ||||
Issuance of common stock, net | $ 32,000 | 35,115,000 | 35,147,000 | ||
Issuance of common stock, net (in shares) | 3,220,075 | ||||
Issuance of common stock upon exercise of warrants | $ 2,000 | 478,000 | 480,000 | ||
Issuance of common stock upon exercise of warrants (in shares) | 160,000 | ||||
Balance at Jun. 30, 2021 | $ 158,000 | 470,335,000 | (437,502,000) | 2,000 | $ 32,993,000 |
Balance (in shares) at Jun. 30, 2021 | 15,781,040 | 15,781,040 | |||
Balance at Mar. 31, 2021 | $ 158,000 | 470,268,000 | (433,271,000) | (2,000) | $ 37,153,000 |
Balance (in shares) at Mar. 31, 2021 | 15,779,160 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (4,231,000) | (4,231,000) | |||
Other comprehensive income (loss) | 4,000 | 4,000 | |||
Exercise of stock options | $ 0 | 7,000 | 7,000 | ||
Exercise of stock options (in shares) | 1,776 | ||||
Stock-based compensation | 60,000 | 60,000 | |||
Issuance of common stock upon exercise of warrants (in shares) | 104 | ||||
Balance at Jun. 30, 2021 | $ 158,000 | $ 470,335,000 | $ (437,502,000) | $ 2,000 | $ 32,993,000 |
Balance (in shares) at Jun. 30, 2021 | 15,781,040 | 15,781,040 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Operating activities: | ||
Net loss | $ (8,946,000) | $ (12,487,000) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 7,000 | 5,000 |
Change in fair value of warrant liabilities | 209,000 | 119,000 |
Stock compensation expense | 125,000 | 185,000 |
Changes in assets and liabilities: | ||
Receivables | 10,000 | 57,000 |
Prepaid expenses and other current assets | 265,000 | (70,000) |
Other assets | 10,000 | |
Accounts payable | (543,000) | 877,000 |
Accrued expenses and other current liabilities | (1,979,000) | (418,000) |
Deferred revenue | (113,000) | (112,000) |
Net cash used in operating activities | (10,955,000) | (11,844,000) |
Investing activities: | ||
Payments for purchase of property and equipment | (15,000) | |
Net cash used in investing activities | (15,000) | |
Financing activities: | ||
Proceeds from the sale of common stock and warrants, net of costs | 35,147,000 | 9,062,000 |
Proceeds from the exercise of warrants | 480,000 | 7,298,000 |
Proceeds from the exercise of stock options | 24,000 | |
Net cash provided by financing activities | 35,651,000 | 16,360,000 |
Effect of foreign currency translation on cash | (12,000) | 1,000 |
Net increase in cash and cash equivalents | 24,684,000 | 4,502,000 |
Cash and cash equivalents at beginning of period | 19,025,000 | 22,726,000 |
Cash and cash equivalents at end of period | $ 43,709,000 | $ 27,228,000 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2021 | |
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 products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. The Company believes that the product candidates in its pipeline have the potential to be efficacious in a variety of cancers with unmet medical need. The Company currently has the following two clinical-stage programs: 1. ON 123300 in solid tumors; and 2. oral rigosertib alone or in combination with PD-1 inhibitors for treatment of KRAS-mutated solid tumors. 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 Biopharmaceuticals, Inc. (“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, which was received in January 2020. The Company and HanX also intended for these studies to comply with the FDA standards for IND approval. Accordingly, such studies were used by the Company for an IND filing with the US FDA in November 2020. The FDA Study May Proceed letter was issued in December 2020. The Company maintains global rights outside of China. On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “Pint License 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 American countries. In May 2019, the Company entered into a License and Collaboration Agreement (the “HanX License Agreement”) with 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 human therapeutic uses in the People’s Republic of China, Hong Kong, Macau and Taiwan (the “HanX Territory”). In connection with the HanX 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 as set forth in the Knight License Agreement) (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 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. On May 20, 2021, the Company amended its certificate of incorporation to effect a one-for-fifteen reverse stock split of its common stock. All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect this one-for-fifteen reverse stock split. On May 20, 2021, the Company amended its certificate of incorporation to decrease the number of authorized shares of common stock par value $0.01 per share from 250,000,000 to 125,000,000. Liquidity The Company has incurred recurring operating losses since inception. For the six months ended June 30, 2021, the Company incurred a net loss of $8,946,000 and as of June 30, 2021 the Company had generated an accumulated deficit of $437,502,000. 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 June 30, 2021, the Company had cash and cash equivalents of $43,709,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. On January 11, 2021, the Company closed on an offering of common stock. The Company issued 1,303,408 shares of common stock and net proceeds were approximately $8.5 million. On February 16, 2021, the Company closed on an offering of common stock. The Company issued 1,916,667 shares of common stock and net proceeds were approximately $26.7 million. Following the unsuccessful conclusion of the INSPIRE trial, the Company has taken steps to reduce its cash expenditures. From September 2020 to December 2020, the Company implemented a workforce reduction of employees in research and development who were primarily focused on preparing the NDA for the use of rigosertib in higher risk MDS. In total, 10 employees were terminated, representing approximately 43% of the Company’s workforce. A severance related charge of approximately $1,207,000, which includes a non-cash charge of approximately $29,000 related to the accelerated vesting of outstanding stock options, was recorded in the year ended December 31, 2020. The accrued severance balance remaining at June 30, 2021 was $177,000 and is included in accrued expenses and other liabilities on the balance sheet. It will be paid in periodic amounts through September 2021. On October 30, 2020, the Company notified its landlord of its intention to not renew its office space lease. The lease expired in February 2021 and was modified to a month-to-month lease for a portion of the space. The lease terminated in June 2021 and the Company has relocated to temporary office space with all employees working remotely. 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 believes that its cash and cash equivalents will be sufficient to fund its ongoing trials and business operations for more than eighteen months from the date of this filing. COVID-19 While the Company is not aware of a material impact from the novel coronavirus disease (“COVID-19”) pandemic through June 30, 2021, the full extent to which COVID-19 will directly or indirectly impact the Company’s business, results of operations and financial condition, including manufacturing, clinical trials and research and development costs, depends on future developments that are highly uncertain at this time. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2021 and 2020, the consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2021 and 2020 and the condensed consolidated statements of cash flows for the six months ended June 30, 2021 and 2020 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 June 30, 2021, the results of its operations for the three and six months ended June 30, 2021 and 2020, and its cash flows for the six months ended June 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2021 and 2020 are unaudited. The results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, 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, 2020 included in the Company’s annual report on Form 10-K filed with the SEC on March 18, 2021. All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-fifteen reverse stock split which was effective May 20, 2021. 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, 2020 included in the Company’s annual report on Form 10-K filed with the SEC on March 18, 2021. 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.” Recent Accounting Pronouncements 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 the Company in 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 | 6 Months Ended |
Jun. 30, 2021 | |
Revenue. | |
Revenue | 3. Revenue The Company’s revenue during the three and six months ended June 30, 2021 and 2020 was from its license and collaboration agreement with SymBio. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Symbio Upfront license fee recognition over time $ 57,000 $ 56,000 $ 113,000 $ 112,000 Supplies — — — (4,000) $ 57,000 $ 56,000 $ 113,000 $ 108,000 Deferred revenue is as follows: Symbio Upfront Payment Deferred balance at December 31, 2020 $ 3,695,000 Recognition to revenue 113,000 Deferred balance at June 30, 2021 $ 3,582,000 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 and 2020 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): June 30, 2021 2020 Warrants 511,202 1,457,479 Stock options 60,431 69,640 571,633 1,527,119 |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2021 | |
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 Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were converted to common stock) for the six months ended June 30, 2021 is as follows: Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants June 30, Description Classification Price Date 2020 Issued Exercised Expired 2021 Non-tradable warrants Liability $ 2,587.50 July 2021 430 — — — 430 Tradable warrants Liability $ 1,107.00 July 2021 14,187 — — — 14,187 Non-tradable pre-funded warrants Equity $ 2.25 July 2023 26 — — — 26 Non-tradable warrants Equity $ 24.00 December 2022 26,189 — — — 26,189 Non-tradable warrants Equity $ 211.50 March 2021 333 — — (333) — Non-tradable warrants Equity $ 317.25 March 2021 556 — — (556) — Non-tradable warrants Equity $ 116.8425 June 2021 1,000 — — (1,000) — Non-tradable pre-funded warrants Equity $ 2.25 none 3,522 — — — 3,522 Non-tradable warrants Equity $ 24.00 December 2022 120,407 — — — 120,407 Non-tradable pre-funded warrants Equity $ 2.25 none 4,974 — — — 4,974 Non-tradable warrants Equity $ 30.00 September 2023 7,306 — — — 7,306 Non-tradable warrants Equity $ 3.00 November 2024 409,500 — (160,000) — 249,500 Non-tradable warrants Equity $ 6.54375 December 2024 16,953 — — — 16,953 Non-tradable warrants Equity $ 6.75450 December 2024 46,263 — — — 46,263 Non-tradable warrants Equity $ 6.77850 December 2023 29,968 — — — 29,968 681,614 — (160,000) (1,889) 519,725 The tradable warrants which expired in July 2021 were issued in connection with a financing transaction completed in August 2016. Subsequent to the closing of that financing transaction, the Company executed a one obtained by the exercise of all of the outstanding warrants, 14,187; and shows the exercise price for 225 of the warrants, $1,107.00. |
Balance Sheet Detail
Balance Sheet Detail | 6 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Detail | |
Balance Sheet Detail | 6. Balance Sheet Detail Prepaid expenses and other current assets: June 30, December 31, 2021 2020 Research and development $ 42,000 $ 189,000 Manufacturing 144,000 90,000 Insurance 80,000 263,000 Other 191,000 180,000 $ 457,000 $ 722,000 Property and equipment: June 30, December 31, 2021 2020 Property and equipment $ 70,000 $ 70,000 Accumulated depreciation (25,000) (18,000) $ 45,000 $ 52,000 Accrued expenses and other current liabilities: June 30, December 31, 2021 2020 Research and development $ 1,849,000 $ 2,541,000 Employee compensation 990,000 2,239,000 Professional fees 144,000 182,000 $ 2,983,000 $ 4,962,000 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
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 861 shares of Common Stock, at a purchase price of $2,137.50 per share and warrants to purchase up to 430 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 June 30, 2021 and December 31, 2020. These warrants expired in July 2021. On July 29, 2016 the Company closed on a Rights Offering, issuing 16,000 shares of Common Stock, 14,187 Tradable Warrants and 2,918 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 $1,107 per share. After the one -year anniversary of issuance, the Company may redeem the Tradable Warrants for $0.015 per Tradable Warrant if the volume weighted average price of its Common Stock is above $2,767.50 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, 2020 and 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 June 30, 2021 and December 31, 2020: Fair Value Measurement as of: June 30, 2021 December 31, 2020 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ 530,000 $ — $ — $ 530,000 $ 321,000 $ — $ — $ 321,000 Non-tradable warrants liability — — — — — — — — Total $ 530,000 $ — $ — $ 530,000 $ 321,000 $ — $ — $ 321,000 There were no transfers between levels in any of the periods reported. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation 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. 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 26,823. The 2018 Plan was amended and restated 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 39,300 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 June 30, 2021, there were 5,205 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 and six months ended June 30, 2021 and 2020: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 General and administrative $ 43,000 $ 46,000 $ 99,000 $ 91,000 Research and development 17,000 46,000 26,000 94,000 $ 60,000 $ 92,000 $ 125,000 $ 185,000 A summary of stock option activity for the six months ended June 30, 2021 is as follows: Options Outstanding Weighted Weighted- Average Shares Average Remaining Aggregate Available Number Exercise Contractual Intrinsic for Grant of Shares Price Term (in years) Value Balance, December 31, 2020 12,339 57,939 $ 368.10 8.38 $ — Authorized — — Granted (21,000) 21,000 $ 7.80 9.94 21,636 Exercised — (4,642) $ 4.65 8.47 Forfeitures 13,866 (13,866) $ 940.63 7.11 Balance, June 30, 2021 5,205 60,431 $ 124.00 8.73 $ — Vested or expected to vest, June 30, 2021 58,925 $ 124.00 8.73 $ — Exercisable at June 30, 2021 24,261 $ 297.34 7.87 $ — The Company accounts for all stock-based payments made to employees, non-employees and directors using an option pricing model for estimating fair value. Accordingly, stock-based compensation expense is measured based on the estimated fair value of the awards on the date of grant, net of forfeitures. Compensation expense is recognized for the portion that is ultimately expected to vest over the period during which the recipient renders the required services to the Company using the straight-line single option method. 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 June 30, 2021, there was $102,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 2.29 years. The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following: Six months ended June 30, 2021 2020 Risk-free interest rate 1.02 % 0.45 % Expected volatility 123.32 % 105.14 % Expected term 6.25 years 6.00 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 3.80 $ 3.75 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% . ● Estimated forfeiture rate: The Company’s estimated annual forfeiture rate on stock option grants was 4.14% in 2021 and 2020, based on the historical forfeiture experience. G rants of PSUs and SARs On July 9, 2020, the compensation committee of the board of directors and the board approved a cash bonus program of cash-settled stock appreciation right (“2020 SAR”) awards and cash-settled performance stock unit (“2020 PSU”) awards to the Company’s employees. An aggregate of 2020 SAR awards with respect to 256,713 shares of common stock and 2020 PSU awards with respect to 124,220 shares of common stock were granted to the Company’s employees. The 2020 SAR awards will be settled in cash, vest 33% on the first anniversary of the date of grant, and the remaining 67% monthly over the next 24 months, have a per-share base amount of $8.40, which was the closing sales price of a share of the Company’s common stock on the grant date, and are in all cases subject to the terms and conditions of the Company’s form of SAR award agreement. The 2020 PSU awards vest 50% upon the submission of a new drug application (“NDA”) to the U.S. FDA for rigosertib in higher-risk myelodysplastic syndromes (“HR-MDS”) and 50% upon U.S. FDA approval of rigosertib for HR-MDS. The 2020 PSU awards have a maximum value of per share. The maximum price per share is the per-share value based on the Company’s market capitalization at shares on July 9, 2020. In all cases, the 2020 PSU awards are subject to the terms and conditions of the Company’s form of PSU award agreement. In addition, on July 9, 2020, based on the recommendation of the compensation committee, the board approved a change in the non-employee director compensation policy that would provide for an annual SAR award (“2020 Director SAR”) with respect to 8,333 shares of common stock for each of the Company’s non-employee directors. No other changes to the non-employee director compensation policy were approved and, on July 9, 2020, the Board approved the initial 8,333 2020 Director SAR award to each of the non-employee directors for an aggregate total of 58,333 2020 Directors SAR awards granted. The 2020 Director SAR awards vest on the first anniversary of grant subject to the director’s continued service and will be settled in cash, have a per-share base amount of $8.40, and are in all cases subject to the terms and conditions of the Company’s form of 2020 Director SAR award agreement. Each SAR subject to a 2020 SAR award represents the right to a cash payment equal to the excess, if any, of (i) the fair market value of each underlying share of the Company’s common stock, determined on the date of exercise of the SAR minus (ii) the base amount. Pursuant to the terms of the SAR awards, in no event may the cash payment for each SAR exceed $13.20, which is the maximum price per share of $21.60, minus the base amount of $8.40, subject to adjustment in accordance with the terms of the Stock Appreciation Right Award Agreement. The maximum price per share is the per-share value based on the Company’s market capitalization at $250 million and the Company’s outstanding shares of common stock, which was 11,611,829 shares on July 9, 2020. On February 17, 2021, the compensation committee of the board of directors and the board approved a cash bonus program of cash-settled stock appreciation right (“2021 SAR”) awards and cash-settled performance stock unit (“2021 PSU”) awards to the Company’s employees. An aggregate of 2021 SAR awards with respect to 100,000 shares of common stock and 2021 PSU awards with respect to 100,000 shares of common stock were granted to the Company’s employees. The 2021 SAR awards will be settled in cash, vest 33% on the first anniversary of the date of grant, and the remaining 67% monthly over the next 24 months, have a per-share base amount of $22.65, which was the closing sales price of a share of the Company’s common stock on the grant date, and are in all cases subject to the terms and conditions of the Company’s form of SAR award agreement. Each SAR subject to a 2021 SAR award represents the right to a cash payment equal to the excess, if any, of (i) the fair market value of each underlying share of the Company’s common stock, determined on the date of exercise of the 2021 SAR minus (ii) the base amount. Pursuant to the terms of the 2021 SAR awards, in no event may the cash payment for each SAR exceed $15.45, which is the maximum price per share of $38.10, minus the base amount of $22.65 , subject to adjustment in accordance with the terms of the Stock Appreciation Right Award Agreement. The maximum price per share is the per-share value based on the Company’s market capitalization at The 2021 PSU awards vest 20% upon the initiation of a new clinical program with an in-licensed compound, 20% for reaching the recommended Phase 2 dose for any compound, 20% for the first patient enrolled in the expansion cohort of the Phase 1 ON123300 clinical trial, 20% for the first patient enrolled in a registrational study for any compound, and 20% for the topline data of a registrational study for any compound. The per share. The maximum price per share is the per-share value based on the Company’s approximate market capitalization at shares on February 17, 2021. In all cases, the 2021 PSU awards are subject to the terms and conditions of the Company’s form of PSU award agreement. The fair value of the 2021 SARs granted has been estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: Six months ended June 30, 2021 Risk-free interest rate 0.95 % Expected volatility 129.79 % Expected term 6.5 years Expected dividend yield 0 % Weighted average grant date fair value $ 0.62 During the six months ended June 30, 2021, the Company recognized $521,000 of compensation expense related to the SARs and PSUs. Included in compensation expense related to SARs is and is included in accrued expenses. As of June 30, 2021, there was |
Research Agreements
Research Agreements | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 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. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Jun. 30, 2021 | |
Related-Party Transactions | |
Related-Party Transactions | 10. Related-Party Transactions The Company entered into a research agreement, as subsequently amended, with the Mount Sinai School of Medicine (“Mount Sinai”), with which a former member of its board of directors and a stockholder is affiliated. The agreement expired in June 2020 and was not renewed. The board member left the Company’s board in August 2020. Mount Sinai is undertaking research on behalf of the Company on the terms set forth in the agreements. Mount Sinai, in connection 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. Payments to Mount Sinai under this research agreement for the three months ended June 30, 2021 and 2020 were $0 and $77,000, respectively, and for the six months ended June 30, 2021 and 2020 were $0 and $201,000, respectively. At both June 30, 2021 and December 31, 2020, the Company had $77,000 payable to Mount Sinai under this agreement. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Event On July 30, 2021, stockholders |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2021 and 2020, the consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2021 and 2020 and the condensed consolidated statements of cash flows for the six months ended June 30, 2021 and 2020 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 June 30, 2021, the results of its operations for the three and six months ended June 30, 2021 and 2020, and its cash flows for the six months ended June 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2021 and 2020 are unaudited. The results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, 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, 2020 included in the Company’s annual report on Form 10-K filed with the SEC on March 18, 2021. All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-fifteen reverse stock split which was effective May 20, 2021. |
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, 2020 included in the Company’s annual report on Form 10-K filed with the SEC on March 18, 2021. 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.” |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 the Company in 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) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue. | |
Schedule of recognized revenue under funding, license and collaboration agreements | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Symbio Upfront license fee recognition over time $ 57,000 $ 56,000 $ 113,000 $ 112,000 Supplies — — — (4,000) $ 57,000 $ 56,000 $ 113,000 $ 108,000 |
Schedule of deferred revenue | Symbio Upfront Payment Deferred balance at December 31, 2020 $ 3,695,000 Recognition to revenue 113,000 Deferred balance at June 30, 2021 $ 3,582,000 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Net Loss Per Share of Common Stock | |
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | June 30, 2021 2020 Warrants 511,202 1,457,479 Stock options 60,431 69,640 571,633 1,527,119 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Warrants | |
Schedule of warrants outstanding and warrant activity | Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants June 30, Description Classification Price Date 2020 Issued Exercised Expired 2021 Non-tradable warrants Liability $ 2,587.50 July 2021 430 — — — 430 Tradable warrants Liability $ 1,107.00 July 2021 14,187 — — — 14,187 Non-tradable pre-funded warrants Equity $ 2.25 July 2023 26 — — — 26 Non-tradable warrants Equity $ 24.00 December 2022 26,189 — — — 26,189 Non-tradable warrants Equity $ 211.50 March 2021 333 — — (333) — Non-tradable warrants Equity $ 317.25 March 2021 556 — — (556) — Non-tradable warrants Equity $ 116.8425 June 2021 1,000 — — (1,000) — Non-tradable pre-funded warrants Equity $ 2.25 none 3,522 — — — 3,522 Non-tradable warrants Equity $ 24.00 December 2022 120,407 — — — 120,407 Non-tradable pre-funded warrants Equity $ 2.25 none 4,974 — — — 4,974 Non-tradable warrants Equity $ 30.00 September 2023 7,306 — — — 7,306 Non-tradable warrants Equity $ 3.00 November 2024 409,500 — (160,000) — 249,500 Non-tradable warrants Equity $ 6.54375 December 2024 16,953 — — — 16,953 Non-tradable warrants Equity $ 6.75450 December 2024 46,263 — — — 46,263 Non-tradable warrants Equity $ 6.77850 December 2023 29,968 — — — 29,968 681,614 — (160,000) (1,889) 519,725 |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Detail | |
Schedule of prepaid expenses and other current assets | June 30, December 31, 2021 2020 Research and development $ 42,000 $ 189,000 Manufacturing 144,000 90,000 Insurance 80,000 263,000 Other 191,000 180,000 $ 457,000 $ 722,000 |
Schedule of property and equipment | June 30, December 31, 2021 2020 Property and equipment $ 70,000 $ 70,000 Accumulated depreciation (25,000) (18,000) $ 45,000 $ 52,000 |
Schedule of accrued expenses and other current liabilities | June 30, December 31, 2021 2020 Research and development $ 1,849,000 $ 2,541,000 Employee compensation 990,000 2,239,000 Professional fees 144,000 182,000 $ 2,983,000 $ 4,962,000 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | Fair Value Measurement as of: June 30, 2021 December 31, 2020 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ 530,000 $ — $ — $ 530,000 $ 321,000 $ — $ — $ 321,000 Non-tradable warrants liability — — — — — — — — Total $ 530,000 $ — $ — $ 530,000 $ 321,000 $ — $ — $ 321,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Schedule of stock-based compensation expense | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 General and administrative $ 43,000 $ 46,000 $ 99,000 $ 91,000 Research and development 17,000 46,000 26,000 94,000 $ 60,000 $ 92,000 $ 125,000 $ 185,000 |
Schedule of stock option activity | Options Outstanding Weighted Weighted- Average Shares Average Remaining Aggregate Available Number Exercise Contractual Intrinsic for Grant of Shares Price Term (in years) Value Balance, December 31, 2020 12,339 57,939 $ 368.10 8.38 $ — Authorized — — Granted (21,000) 21,000 $ 7.80 9.94 21,636 Exercised — (4,642) $ 4.65 8.47 Forfeitures 13,866 (13,866) $ 940.63 7.11 Balance, June 30, 2021 5,205 60,431 $ 124.00 8.73 $ — Vested or expected to vest, June 30, 2021 58,925 $ 124.00 8.73 $ — Exercisable at June 30, 2021 24,261 $ 297.34 7.87 $ — |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Six months ended June 30, 2021 2020 Risk-free interest rate 1.02 % 0.45 % Expected volatility 123.32 % 105.14 % Expected term 6.25 years 6.00 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 3.80 $ 3.75 |
2021 SAR | |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Six months ended June 30, 2021 Risk-free interest rate 0.95 % Expected volatility 129.79 % Expected term 6.5 years Expected dividend yield 0 % Weighted average grant date fair value $ 0.62 |
Nature of Business (Details)
Nature of Business (Details) | Feb. 16, 2021USD ($)shares | Jan. 11, 2021USD ($)shares | Jul. 29, 2016shares | Jan. 05, 2016USD ($)shares | Jun. 30, 2021USD ($)Program$ / sharesshares | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($)employee$ / sharesshares | Jun. 30, 2021USD ($)Program$ / sharesshares | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($)$ / sharesshares | May 31, 2021shares | May 20, 2021$ / sharesshares | May 19, 2021shares | Jul. 09, 2020shares | Dec. 31, 2019USD ($) |
Nature of Business | |||||||||||||||
Number of clinical programs (in programs) | Program | 2 | 2 | |||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||
Common stock authorized (in shares) | shares | 125,000,000 | 250,000,000 | 125,000,000 | 250,000,000 | 125,000,000 | 250,000,000 | |||||||||
Net loss | $ 4,231,000 | $ 7,395,000 | $ 8,946,000 | $ 12,487,000 | |||||||||||
Accumulated deficit | 437,502,000 | $ 428,556,000 | 437,502,000 | $ 428,556,000 | |||||||||||
Cash and cash equivalents | $ 43,709,000 | $ 27,228,000 | $ 19,025,000 | $ 43,709,000 | 27,228,000 | $ 19,025,000 | $ 22,726,000 | ||||||||
Common stock outstanding (in shares) | shares | 15,781,040 | 12,396,219 | 15,781,040 | 12,396,219 | 11,611,829 | ||||||||||
Net proceeds | $ 26,700,000 | $ 8,500,000 | $ 1,840,000 | $ 35,147,000 | 9,062,000 | ||||||||||
Warrants Exercised | shares | 160,000 | ||||||||||||||
Proceeds from the exercise of warrants | $ 480,000 | $ 7,298,000 | |||||||||||||
Issuance of common stock, net (in shares) | shares | 1,916,667 | 1,303,408 | 16,000 | 861 | |||||||||||
FTE positions eliminated | employee | 10 | ||||||||||||||
FTE eliminated positions (as percent of workforce) | 43.00% | ||||||||||||||
Severance charge | $ 1,207,000 | ||||||||||||||
Accrued severance balance | $ 177,000 | $ 177,000 | |||||||||||||
Non-cash charge, accelerated options | $ 29,000 | ||||||||||||||
Stock called by warrants or rights | shares | 430 | 3,192,140 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Segment Information (Details) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
Reverse stock split | one-for-fifteen |
Revenue (Details)
Revenue (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue | ||||
Revenue | $ 57,000 | $ 56,000 | $ 113,000 | $ 108,000 |
Deferred revenue | ||||
Balance at the beginning of the period | 226,000 | |||
Balance at the end of the period | 226,000 | 226,000 | ||
SymBio | ||||
Deferred revenue | ||||
Balance at the beginning of the period | 3,695,000 | |||
Recognition to revenue | 113,000 | |||
Balance at the end of the period | 3,582,000 | 3,582,000 | ||
SymBio | License | ||||
Revenue | ||||
Revenue | $ 57,000 | $ 56,000 | $ 113,000 | 112,000 |
SymBio | Supplies and other | ||||
Revenue | ||||
Revenue | $ (4,000) |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
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 | 571,633 | 1,527,119 |
Common Stock 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 | 511,202 | 1,457,479 |
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 | 60,431 | 69,640 |
Warrants (Details)
Warrants (Details) | 1 Months Ended | 6 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2021$ / sharesshares | May 31, 2021$ / sharesshares | Jan. 05, 2016shares | |
Warrants | ||||
Reverse stock split ratio | 0.0667 | |||
Number of securities to each class of warrant (in shares) | 3,192,140 | 430 | ||
Warrant exercise price (in dollars per share) | $ / shares | $ 4.92 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 681,614 | |||
Warrants Exercised (in shares) | (160,000) | |||
Warrants Expired (in shares) | (1,889) | |||
Balance at end of the period (in shares) | 519,725 | |||
Certain institutional and accredited investors | ||||
Warrants | ||||
Number of securities to each class of warrant (in shares) | 225 | |||
Non-tradable warrants with exercise price 172.50 Liability | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 2,587.50 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 430 | |||
Balance at end of the period (in shares) | 430 | |||
Tradable warrants with exercise price 73.80 Liability | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 1,107 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 14,187 | |||
Balance at end of the period (in shares) | 14,187 | |||
Non-tradable pre-funded warrants with exercise price 0.15 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 2.25 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 26 | |||
Balance at end of the period (in shares) | 26 | |||
Non-tradable warrants with exercise price 1.60 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 24 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 26,189 | |||
Balance at end of the period (in shares) | 26,189 | |||
Non-tradable warrants with exercise price 14.10 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 211.50 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 333 | |||
Warrants Expired (in shares) | (333) | |||
Non-tradable warrants with exercise price 21.15 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 317.25 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 556 | |||
Warrants Expired (in shares) | (556) | |||
Non-tradable warrants with exercise price 7.7895 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 116.8425 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 1,000 | |||
Warrants Expired (in shares) | (1,000) | |||
Non-tradable pre-funded warrants with exercise Price 0.15 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 2.25 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 3,522 | |||
Balance at end of the period (in shares) | 3,522 | |||
Non-tradable warrants with exercise price 1.600 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 24 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 120,407 | |||
Balance at end of the period (in shares) | 120,407 | |||
Non-tradable pre-funded warrants with exercise Price 0.15 Equity1 | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 2.25 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 4,974 | |||
Balance at end of the period (in shares) | 4,974 | |||
Non-tradable warrants with exercise price 2.00 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 30 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 7,306 | |||
Balance at end of the period (in shares) | 7,306 | |||
Non-tradable warrants with exercise price 0.20 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 409,500 | |||
Warrants Exercised (in shares) | (160,000) | |||
Balance at end of the period (in shares) | 249,500 | |||
Non-tradable warrants with exercise price 0.43625 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 6.54375 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 16,953 | |||
Balance at end of the period (in shares) | 16,953 | |||
Non-tradable warrants with exercise price 0.45030 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 6.75450 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 46,263 | |||
Balance at end of the period (in shares) | 46,263 | |||
Non-tradable Warrants with Exercise Price 0.45190 Equity | ||||
Warrants | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 6.77850 | |||
Warrants outstanding and warrant activity | ||||
Balance at beginning of the period (in shares) | 29,968 | |||
Balance at end of the period (in shares) | 29,968 |
Balance Sheet Detail - Prepaid
Balance Sheet Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Prepaid expenses and other current assets: | ||
Research and development | $ 42,000 | $ 189,000 |
Manufacturing | 144,000 | 90,000 |
Insurance | 80,000 | 263,000 |
Other | 191,000 | 180,000 |
Prepaid expenses and other current assets | $ 457,000 | $ 722,000 |
Balance Sheet Detail - Property
Balance Sheet Detail - Property and Equipment (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Property and Equipment | ||
Property and equipment | $ 70,000 | $ 70,000 |
Accumulated depreciation | (25,000) | (18,000) |
Property and equipment, net | $ 45,000 | $ 52,000 |
Balance Sheet Detail - Accrued
Balance Sheet Detail - Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Detail | ||
Research and development | $ 1,849,000 | $ 2,541,000 |
Employee compensation | 990,000 | 2,239,000 |
Professional fees | 144,000 | 182,000 |
Accrued expenses and other current liabilities: | $ 2,983,000 | $ 4,962,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Feb. 16, 2021 | Jan. 11, 2021 | Jul. 29, 2016 | Jan. 05, 2016 | Jun. 30, 2021 | Jun. 30, 2020 | May 31, 2021 | Dec. 31, 2020 | Jul. 09, 2020 |
Sale of Securities | |||||||||
Aggregate shares issued | 1,916,667 | 1,303,408 | 16,000 | 861 | |||||
Price per share (in dollars per share) | $ 2,137.50 | $ 21.60 | |||||||
Stock called by warrants or rights | 430 | 3,192,140 | |||||||
Proceeds from Issuance of Common Stock | $ 26,700,000 | $ 8,500,000 | $ 1,840,000 | $ 35,147,000 | $ 9,062,000 | ||||
Estimated fair value using the Black-Scholes pricing model | $ 0 | $ 0 |
Fair Value Measurements - Right
Fair Value Measurements - Rights Offering (Details) - $ / shares | Feb. 16, 2021 | Jan. 11, 2021 | Jul. 29, 2016 | Jan. 05, 2016 | May 31, 2021 | Jul. 29, 2017 |
Subsidiary, Sale of Stock [Line Items] | ||||||
Issuance of common stock, net (in shares) | 1,916,667 | 1,303,408 | 16,000 | 861 | ||
Exercise price (in dollars per share) | $ 4.92 | |||||
Tradable warrants liability | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Rights or warrants issued (in shares) | 14,187 | |||||
Exercise price (in dollars per share) | $ 1,107 | $ 0.015 | ||||
Class Of Warrant Or Right Initially Exercisable Term | five | |||||
Redemption period (in years) | one | |||||
Volume weighted average price per share of common stock (in dollars per share) | $ 2,767.50 | |||||
Threshold consecutive trading days (in days) | 10 days | |||||
Pre-funded warrants | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Rights or warrants issued (in shares) | 2,918 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy Table (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Liabilities measured at fair value | ||
Warrant liability | $ 530,000 | $ 321,000 |
Recurring basis | ||
Liabilities measured at fair value | ||
Total | 530,000 | 321,000 |
Recurring basis | Tradable warrants liability | ||
Liabilities measured at fair value | ||
Warrant liability | 530,000 | 321,000 |
Recurring basis | Level 1 | ||
Liabilities measured at fair value | ||
Total | 530,000 | 321,000 |
Recurring basis | Level 1 | Tradable warrants liability | ||
Liabilities measured at fair value | ||
Warrant liability | $ 530,000 | $ 321,000 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ in Millions | Feb. 17, 2021 | Jul. 09, 2020 | Jun. 17, 2019 | Jun. 30, 2021 | Dec. 31, 2020 |
Stock-Based Compensation | |||||
Market Capitalization | $ 600 | $ 250 | |||
2018 Plan | |||||
Stock-Based Compensation | |||||
Shares authorized (in shares) | 26,823 | ||||
Additional shares authorized (in shares) | 39,300 | ||||
Stock options | |||||
Stock-Based Compensation | |||||
Common Stock available for future issuance (in shares) | 5,205 | 12,339 | |||
Stock options | 2018 Plan | |||||
Stock-Based Compensation | |||||
Common Stock available for future issuance (in shares) | 5,205 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock-Based Compensation | ||||
Net tax benefits related to the stock-based compensation costs | $ 0 | |||
Compensation expense | $ 60,000 | $ 92,000 | 125,000 | $ 185,000 |
General and administrative | ||||
Stock-Based Compensation | ||||
Compensation expense | 43,000 | 46,000 | 99,000 | 91,000 |
Research and development | ||||
Stock-Based Compensation | ||||
Compensation expense | $ 17,000 | $ 46,000 | $ 26,000 | $ 94,000 |
Stock-Based Compensation - Acti
Stock-Based Compensation - Activity (Details) - Stock options | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020$ / sharesshares | |
Shares Available for Grant | ||
Balance at the beginning of the period (in shares) | 12,339 | |
Granted (in shares) | (21,000) | |
Exercised (in shares) | 4,642 | |
Forfeitures (in shares) | 13,866 | |
Balance at the end of the period (in shares) | 5,205 | 12,339 |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 57,939 | |
Granted (in shares) | 21,000 | |
Exercised (in shares) | (4,642) | |
Forfeitures (in shares) | (13,866) | |
Balance at the end of the period (in shares) | 60,431 | 57,939 |
Vested or expected to vest at the end of the period (in shares) | 58,925 | |
Exercisable at the end of the period (in shares) | 24,261 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 368.10 | |
Granted (in dollars per share) | $ / shares | 7.80 | |
Exercised (in dollars per share) | $ / shares | 4.65 | |
Forfeitures (in dollars per share) | $ / shares | 940.63 | |
Balance at the end of the period (in dollars per share) | $ / shares | 124 | $ 368.10 |
Vested or expected to vest at the end of the period (in dollars per share) | $ / shares | 124 | |
Exercisable at the end of the period (in dollars per share) | $ / shares | $ 297.34 | |
Additional Disclosures | ||
Weighted average remaining contractual term | 8 years 8 months 23 days | 8 years 4 months 17 days |
Weighted average remaining contractual term of options granted | 9 years 11 months 8 days | |
Weighted average remaining contractual term of options exercised | 8 years 5 months 19 days | |
Weighted average remaining contractual term of options forfeitures | 7 years 1 month 9 days | |
Weighted average remaining contractual term of options vested or expected to vest | 8 years 8 months 23 days | |
Weighted average remaining contractual term of options exercisable | 7 years 10 months 13 days | |
Aggregate intrinsic value of options granted | $ | $ 21,636 |
Stock-Based Compensation - Unre
Stock-Based Compensation - Unrecognized Compensation Expense (Details) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Stock options | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 102,000 |
Weighted-average period for recognizing unrecognized compensation expense related to unvested stock options (in years) | 2 years 3 months 14 days |
SAR awards | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 521,000 |
2020 SAR | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | 53,000 |
2021 SAR | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 664,000 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Assumptions used | ||||
Expected term (in years) | 6 years 6 months | |||
Expected dividend yield (as a percent) | 0.00% | |||
SARs liability | $ 102,000 | |||
Stock options | ||||
Assumptions used | ||||
Risk-free interest rate (as a percent) | 1.02% | 0.45% | ||
Expected volatility (as a percent) | 123.32% | 105.14% | ||
Expected term (in years) | 6 years 3 months | 6 years | ||
Expected dividend yield (as a percent) | 0.00% | 0.00% | ||
Weighted average grant date fair value (in dollars per share) | $ 3.80 | $ 3.75 | ||
Annualized forfeiture rate (as a percent) | 4.14% | 4.14% | ||
2021 SAR | ||||
Assumptions used | ||||
Risk-free interest rate (as a percent) | 0.95% | |||
Expected volatility (as a percent) | 129.79% | |||
Expected dividend yield (as a percent) | 0.00% | |||
Weighted average grant date fair value (in dollars per share) | $ 0.62 |
Stock-Based Compensation - Gran
Stock-Based Compensation - Grants of PSUs and SARs (Details) - USD ($) | Feb. 17, 2021 | Jul. 09, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Jan. 05, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | $ 21.60 | $ 2,137.50 | ||||||
Common stock outstanding (in shares) | 11,611,829 | 15,781,040 | 15,781,040 | 12,396,219 | ||||
Market capitalization | $ 600,000,000 | $ 250,000,000 | ||||||
Compensation expense | $ 60,000 | $ 92,000 | $ 125,000 | $ 185,000 | ||||
SAR Award Agreement [member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | $ 15.45 | $ 15.45 | ||||||
Common stock outstanding (in shares) | 15,767,492 | |||||||
SAR Award Agreement [member] | Minimum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | 38.10 | 38.10 | ||||||
SAR Award Agreement [member] | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | $ 22.65 | $ 22.65 | ||||||
2020 PSU | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock option grants | 124,220 | |||||||
2021 PSU | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock outstanding (in shares) | 15,767,492 | |||||||
Market capitalization | $ 600,000,000 | |||||||
Shares issued | 100,000 | 100,000 | ||||||
2021 PSU | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | $ 38.10 | |||||||
2021 PSU | Initiation of a new clinical program with an in-licensed compound | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 20.00% | |||||||
2021 PSU | Reaching the recommended Phase 2 dose for any compound | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 20.00% | |||||||
2021 PSU | First patient enrolled in the expansion cohort of the Phase 1 ON123300 clinical trial | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 20.00% | |||||||
2021 PSU | First patient enrolled in a registrational study for any compound | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 20.00% | |||||||
2021 PSU | Topline data of a registrational study for any compound | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 20.00% | |||||||
SAR awards | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share base amount (per share) | $ 8.40 | |||||||
Share Based Compensation Arrangement By Share Based Payment Award for Cash Payment Of Each SAR | 13.20 | |||||||
Compensation expense | $ 442,000 | |||||||
Unrecognized compensation expense related to unvested stock options | $ 521,000 | 521,000 | ||||||
SAR awards | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share price (in dollars per share) | $ 21.60 | |||||||
2020 SAR | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock option grants | 256,713 | |||||||
Share base amount (per share) | $ 8.40 | |||||||
Unrecognized compensation expense related to unvested stock options | $ 53,000 | $ 53,000 | ||||||
2021 SAR | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 67.00% | 33.00% | ||||||
Share base amount (per share) | $ 22.65 | |||||||
Shares issued | 100,000 | 100,000 | ||||||
Unrecognized compensation expense related to unvested stock options | $ 664,000 | $ 664,000 | ||||||
Vesting Percentage One | 2020 PSU | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 50.00% | |||||||
Vesting Percentage One | 2020 SAR | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 33.00% | |||||||
Vesting Percentage Two | 2020 PSU | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 50.00% | |||||||
Vesting Percentage Two | 2020 SAR | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 67.00% | |||||||
Non employee directors | SAR awards | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of awards issued | 8,333 |
Research Agreements (Details)
Research Agreements (Details) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
License | |
Research Agreements | |
Revenue | $ 0 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - Mount Sinai - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Related-Party Transactions | |||||
Payments to related party | $ 0 | $ 77,000 | $ 0 | $ 201,000 | |
Amounts due to related party | $ 77,000 | $ 77,000 | $ 77,000 |
Securities Registrations and Sa
Securities Registrations and Sales Agreements - January 2020 Offering (Details) - USD ($) | Feb. 16, 2021 | Jan. 11, 2021 | Jul. 29, 2016 | Jan. 05, 2016 | Dec. 31, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | May 31, 2021 |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 1,916,667 | 1,303,408 | 16,000 | 861 | ||||
Warrant exercise price (in dollars per share) | $ 4.92 | |||||||
Payment of Non-accountable Expenses | $ 85,000 | |||||||
Payment of Clearing Fees | $ 10,000 | |||||||
Securities purchase agreements | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 1,844,168 | |||||||
Common Stock | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 3,220,075 | 1,844,168 | ||||||
Non-tradable warrants with exercise price 2.00 Equity | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrant exercise price (in dollars per share) | $ 30 | |||||||
HCW | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Percentage of management fees on gross proceeds | 7.00% | |||||||
Certain institutional and accredited investors | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Percentage of management fees on gross proceeds | 1.00% |
Securities Registrations and _2
Securities Registrations and Sales Agreements - 2021 Offering (Details) - USD ($) | Feb. 16, 2021 | Feb. 10, 2021 | Jan. 11, 2021 | Jan. 07, 2021 | Jul. 29, 2016 | Jan. 05, 2016 | Dec. 31, 2019 | Jun. 30, 2021 | Jun. 30, 2020 |
Aggregate shares issued | 1,916,667 | 1,303,408 | 16,000 | 861 | |||||
Net proceeds | $ 26,700,000 | $ 8,500,000 | $ 1,840,000 | $ 35,147,000 | $ 9,062,000 | ||||
Securities purchase agreements | |||||||||
Aggregate shares issued | 1,844,168 | ||||||||
Offer price (per share) | $ 5.4225 | ||||||||
Lincoln Park Capital Fund, LLC | The Offering | |||||||||
Expense reimbursement | $ 100,000 | ||||||||
Percentage rights to participate | 50.00% | ||||||||
Threshold period for exercise or conversion of stock | one | ||||||||
Institutional Investors | The Offering | |||||||||
Aggregate shares issued | 1,303,408 | ||||||||
Purchase price | $ 6.675 | ||||||||
Net proceeds | $ 8,500,000 | ||||||||
Guggenheim Securities, LLC | Over-allotment | |||||||||
Aggregate shares issued | 1,666,667 | ||||||||
Purchase price | $ 15 | ||||||||
Threshold period for exercise or conversion of stock | 30 | ||||||||
Net proceeds | $ 26,700,000 | ||||||||
Additional shares agreed to issue | 250,000 | ||||||||
Cash fee | 6.00% | ||||||||
Legal fees and expenses | $ 100,000 |
Subsequent Events (Details)
Subsequent Events (Details) | Jul. 30, 2021shares |
Subsequent Event | |
Subsequent Events: | |
Additional shares authorized (in shares) | 1,300,000 |