Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 01, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36020 | |
Entity Registrant Name | Onconova Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 22-3627252 | |
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 | |
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 | 20,925,992 | |
Title of 12(b) Security | Common Stock, par value $.01 per share | |
Trading Symbol | ONTX | |
Security Exchange Name | NASDAQ | |
Entity Central Index Key | 0001130598 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 42,613 | $ 55,070 |
Receivables | 28 | 28 |
Prepaid expenses and other current assets | 1,110 | 332 |
Total current assets | 43,751 | 55,430 |
Property and equipment, net | 28 | 38 |
Other non-current assets | 1 | 10 |
Total assets | 43,780 | 55,478 |
Current liabilities: | ||
Accounts payable | 3,760 | 2,757 |
Accrued expenses and other current liabilities | 3,350 | 3,132 |
Deferred revenue | 226 | 226 |
Total current liabilities | 7,336 | 6,115 |
Deferred revenue, non-current | 3,073 | 3,243 |
Total liabilities | 10,409 | 9,358 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 5,000,000 shares authorized, none issued and outstanding at September 30, 2022 and December 31, 2021 | ||
Common stock, $0.01 par value, 125,000,000 shares authorized, 20,925,992 and 20,895,563 shares issued and outstanding at September 30, 2022 and December 31, 2021 | 209 | 209 |
Additional paid in capital | 491,486 | 490,644 |
Accumulated deficit | (458,263) | (444,719) |
Accumulated other comprehensive loss | (61) | (14) |
Total stockholders' equity | 33,371 | 46,120 |
Total liabilities and stockholders' equity | $ 43,780 | $ 55,478 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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 | 125,000,000 |
Common stock, shares issued | 20,925,992 | 20,895,563 |
Common stock, shares outstanding | 20,925,992 | 20,895,563 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Condensed Consolidated Statements of Operations | ||||
Revenue | $ 57 | $ 57 | $ 170 | $ 170 |
Operating expenses: | ||||
General and administrative | 2,105 | 2,284 | 6,430 | 7,351 |
Research and development | 3,593 | 1,763 | 7,633 | 5,552 |
Total operating expenses | 5,698 | 4,047 | 14,063 | 12,903 |
Loss from operations | (5,641) | (3,990) | (13,893) | (12,733) |
Change in fair value of warrant liability | 530 | 321 | ||
Other income, net | 243 | 7 | 349 | 13 |
Net loss | $ (5,398) | $ (3,453) | $ (13,544) | $ (12,399) |
Net loss per share, basic (in dollars per share) | $ (0.26) | $ (0.22) | $ (0.65) | $ (0.80) |
Net loss per share, diluted (in dollars per share) | $ (0.26) | $ (0.22) | $ (0.65) | $ (0.80) |
Basic weighted average shares outstanding (in shares) | 20,915,408 | 15,979,180 | 20,902,251 | 15,463,720 |
Diluted weighted average shares outstanding (in shares) | 20,915,408 | 15,979,180 | 20,902,251 | 15,463,720 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (5,398) | $ (3,453) | $ (13,544) | $ (12,399) |
Other comprehensive (loss) income, net of tax: | ||||
Foreign currency translation adjustments, net | (20) | (8) | (47) | (20) |
Other comprehensive (loss) income, net of tax | (20) | (8) | (47) | (20) |
Comprehensive loss | $ (5,418) | $ (3,461) | $ (13,591) | $ (12,419) |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive (loss) income | Total |
Balance at Dec. 31, 2020 | $ 124 | $ 434,593 | $ (428,556) | $ 14 | $ 6,175 |
Balance (in shares) at Dec. 31, 2020 | 12,396,219 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (12,399) | (12,399) | |||
Other comprehensive loss | (20) | (20) | |||
Exercise of stock options | 24 | 24 | |||
Exercise of stock options (in shares) | 4,642 | ||||
Stock-based compensation | 315 | 315 | |||
Issuance of common stock, net | $ 83 | 55,008 | 55,091 | ||
Issuance of common stock, net (in shares) | 8,329,598 | ||||
Shares issued in connection with reverse stock split | 104 | ||||
Issuance of common stock upon exercise of warrants | $ 2 | 478 | 480 | ||
Issuance of common stock upon exercise of warrants (in shares) | 160,000 | ||||
Balance at Sep. 30, 2021 | $ 209 | 490,418 | (440,955) | (6) | 49,666 |
Balance (in shares) at Sep. 30, 2021 | 20,890,563 | ||||
Balance at Jun. 30, 2021 | $ 158 | 470,335 | (437,502) | 2 | 32,993 |
Balance (in shares) at Jun. 30, 2021 | 15,781,040 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (3,453) | (3,453) | |||
Other comprehensive loss | (8) | (8) | |||
Stock-based compensation | 190 | 190 | |||
Issuance of common stock, net | $ 51 | 19,893 | 19,944 | ||
Issuance of common stock, net (in shares) | 5,109,523 | ||||
Balance at Sep. 30, 2021 | $ 209 | 490,418 | (440,955) | (6) | 49,666 |
Balance (in shares) at Sep. 30, 2021 | 20,890,563 | ||||
Balance at Dec. 31, 2021 | $ 209 | 490,644 | (444,719) | (14) | $ 46,120 |
Balance (in shares) at Dec. 31, 2021 | 20,895,563 | 20,895,563 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (13,544) | $ (13,544) | |||
Other comprehensive loss | (47) | (47) | |||
Stock-based compensation | 842 | 842 | |||
Shares issued for vested restricted stock units, shares | 30,429 | ||||
Balance at Sep. 30, 2022 | $ 209 | 491,486 | (458,263) | (61) | $ 33,371 |
Balance (in shares) at Sep. 30, 2022 | 20,925,992 | 20,925,992 | |||
Balance at Jun. 30, 2022 | $ 209 | 491,181 | (452,865) | (41) | $ 38,484 |
Balance (in shares) at Jun. 30, 2022 | 20,895,563 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (5,398) | (5,398) | |||
Other comprehensive loss | (20) | (20) | |||
Stock-based compensation | 305 | 305 | |||
Shares issued for vested restricted stock units, shares | 30,429 | ||||
Balance at Sep. 30, 2022 | $ 209 | $ 491,486 | $ (458,263) | $ (61) | $ 33,371 |
Balance (in shares) at Sep. 30, 2022 | 20,925,992 | 20,925,992 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net loss | $ (13,544) | $ (12,399) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 10 | 10 |
Change in fair value of warrant liabilities | (321) | |
Stock compensation expense | 842 | 315 |
Changes in assets and liabilities: | ||
Receivables | 8 | |
Prepaid expenses and other current assets | (778) | 193 |
Other assets | 9 | 138 |
Accounts payable | 1,003 | (783) |
Accrued expenses and other current liabilities | 218 | (2,213) |
Deferred revenue | (170) | (170) |
Net cash used in operating activities | (12,410) | (15,222) |
Financing activities: | ||
Proceeds from the sale of common stock and warrants, net of costs | 55,091 | |
Proceeds from the exercise of common warrants | 480 | |
Proceeds from the exercise of stock options | 24 | |
Net cash provided by financing activities | 55,595 | |
Effect of foreign currency translation on cash | (47) | (20) |
Net (decrease) increase in cash and cash equivalents | (12,457) | 40,353 |
Cash and cash equivalents at beginning of period | 55,070 | 19,025 |
Cash and cash equivalents at end of period | $ 42,613 | $ 59,378 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2022 | |
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 molecularly targeted 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 has the following two clinical-stage programs: 1. narazaciclib (ON 123300), a multi-targeted kinase inhibitor in solid tumors and hematological malignancies as a single agent or in combination with other anti-cancer therapies; and 2. rigosertib administered alone or in combination for the treatment of 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. 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, and to effect a one-for-fifteen one-for-fifteen Liquidity The Company has incurred recurring operating losses since inception. For the nine months ended September 30, 2022, the Company incurred a net loss of $13,544,000 and as of September 30, 2022 the Company had generated an accumulated deficit of $458,263,000. 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 September 30, 2022, the Company had cash and cash equivalents of $42,613,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. 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 twelve 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 September 30, 2022, 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 uncertain at this time. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021, the consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2022 and 2021 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021 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 September 30, 2022, the results of its operations for the three and nine months ended September 30, 2022 and 2021, and its cash flows for the nine months ended September 30, 2022 and 2021. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2022 and 2021 are unaudited. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, 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, 2021 included in the Company’s annual report on Form 10-K filed with the SEC on March 21, 2022. 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 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, 2021 included in the Company’s annual report on Form 10-K filed with the SEC on March 21, 2022. 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 guidance is not expected to have a material effect on the Company. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Revenue. | |
Revenue | 3. Revenue The Company’s revenue during the three and nine months ended September 30, 2022 and 2021 was from its license and collaboration agreement with SymBio. Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Symbio Upfront license fee recognition over time $ 57,000 $ 57,000 $ 170,000 $ 170,000 Deferred revenue is as follows: Symbio Upfront Payment Deferred balance at December 31, 2021 $ 3,469,000 Recognition to revenue (170,000) Deferred balance at September 30, 2022 $ 3,299,000 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 and 2021 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): September 30, 2022 2021 Warrants 491,586 496,586 Stock options 1,178,498 438,006 1,670,084 934,592 |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2022 | |
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 nine months ended September 30, 2022 is as follows: Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants September 30, Description Classification Price Date 2021 Issued Exercised Expired 2022 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 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 244,500 — — — 244,500 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 — — — 29,968 500,108 — — — 500,108 |
Balance Sheet Detail
Balance Sheet Detail | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Detail | |
Balance Sheet Detail | 6. Balance Sheet Detail Prepaid expenses and other current assets: September 30, December 31, 2022 2021 Research and development $ 411,000 $ 15,000 Manufacturing 202,000 29,000 Insurance 194,000 253,000 Other 303,000 35,000 $ 1,110,000 $ 332,000 Property and equipment: September 30, December 31, 2022 2021 Property and equipment $ 70,000 $ 70,000 Accumulated depreciation (42,000) (32,000) $ 28,000 $ 38,000 Accrued expenses and other current liabilities: September 30, December 31, 2022 2021 Research and development $ 2,122,000 $ 1,759,000 Employee compensation 1,009,000 1,217,000 Professional fees 219,000 156,000 $ 3,350,000 $ 3,132,000 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 7. Fair Value Measurements At both September 30, 2022 and December 31, 2021, the Company had no financial assets and liabilities measured at fair value on a recurring basis. 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. During 2021, the Company had tradable warrants and non-tradable warrants that were classified as liabilities and measured at fair value on a recurring basis. The tradable warrants were listed on the Nasdaq Capital Market. The Company determined that an active and orderly market for the tradable warrants developed and that the Nasdaq Capital Market price was the best indicator of fair value of the warrant liability. The quoted market price was used to determine the fair value. The fair value of the non-tradable warrants was estimated using the Black-Scholes pricing model. All of these tradable and non-tradable warrants expired in July 2021. During the three and nine months ended September 30, 2021, there was a decrease in the fair value of the warrant liability of $530,000 and $321,000, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
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. The 2021 Incentive Compensation Plan (the “2021 Plan”) was unanimously approved by the Company’s shareholders on July 30, 2021. Upon stockholders’ approval of the 2021 Plan, no further awards will be made under the amended 2018 Plan. Under the 2021 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 2021 Plan is 1,300,000. The 2021 Plan was amended and restated following unanimous approval of the Company’s Board of Directors on May 23, 2022 and was approved by the Company’s shareholders on August 18, 2022. The amended 2021 Plan (the “Amended 2021 Plan”) allowed for an additional 2,000,000 shares of the Company’s common stock that may be issued under the Amended 2021 Plan with respect to awards made on and after August 18, 2022. At September 30, 2022, there were 1,906,192 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 related to stock options and restricted stock units as follows for the three and nine months ended September 30, 2022 and 2021: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 General and administrative $ 119,000 $ 153,000 $ 377,000 $ 270,000 Research and development 170,000 29,000 448,000 45,000 $ 289,000 $ 182,000 $ 825,000 $ 315,000 A summary of stock option activity for the nine months ended September 30, 2022 is as follows: Options Outstanding Weighted Weighted- Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term (in years) Value Balance, December 31, 2021 452,999 $ 20.71 9.42 $ — Authorized — Granted 824,165 $ 1.55 9.60 — Exercised — $ — — $ — Forfeitures/adjustments (98,666) $ 1.19 — Balance, September 30, 2022 1,178,498 $ 8.69 9.29 $ — Exercisable at September 30, 2022 202,690 $ 39.45 8.50 $ — 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, 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 September 30, 2022, there was $1,717,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 1.94 years. The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value of stock options include the following: Nine months ended September 30, 2022 2021 Risk-free interest rate 2.45 % 0.89 % Expected volatility 121.72 % 133.83 % Expected term 5.70 years 5.93 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 1.32 $ 4.59 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. ● 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% . On August 2, 2021, the compensation committee of the board of directors approved restricted stock unit grants to the Company’s employees (“2021 RSU”). An aggregate of 104,700 service-based RSUs were issued at a grant date fair value of $5.19. The 2021 RSU awards will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. The 2021 RSU awards were granted under the 2021 Plan. During the nine months ended September 30, 2022, there was a vesting event for 30,429 of 2021 RSUs, there was a forfeiture of 13,400 of the 2021 RSUs. There were no expirations or cancelations of the 2021 RSUs during the period. On February 7, 2022, the compensation committee of the board of directors approved restricted stock unit grants to the Companies employees (“2022 RSU”). An aggregate of 148,343 service-based RSUs were issued at a grant date fair value of $1.82. The 2022 RSU awards will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. The 2021 RSU and 2022 RSU awards were granted under the 2021 Plan. During the nine months ended September 30, 2022, there was a forfeiture of 17,633 of the 2022 RSUs, there were no vesting events, expirations, or cancelations of the 2022 RSU during the period. On June 10, 2022, the compensation committee of the board of directors approved restricted stock unit grants to certain of the Company’s employees (“2022 RSU2”). An aggregate of 24,200 service-based RSUs were issued at a grant date fair value of $1.33. The 2022 RSU2 awards will be settled in stock, vest 33% on each of the first and second anniversary of the date of grant, and vest 34% on the third anniversary of the date of grant. During the nine months ended September 30, 2022, there were no vesting events expirations, or cancelations of the 2022 RSU2. At September 30, 2022, the unrecognized compensation cost related to unvested service-based RSUs was Grants of PSUs and SARs During 2020 and 2021, the compensation committee of the board of directors and the board approved a cash bonus program of cash-settled stock appreciation right (“SAR”) awards to the Company’s employees and non-employee directors, and cash-settled performance stock unit (“PSU”) awards to the Company’s employees. These awards were granted outside of the 2018 Plan and the 2021 Plan. As the Company’s stock price has decreased since these awards, their impact on the results of operations and balance sheet of the Company are not material at September 30, 2022. |
Research Agreements
Research Agreements | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 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. |
Securities Registrations and Sa
Securities Registrations and Sales Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Securities Registrations and Sales Agreements | |
Securities Registrations and Sales Agreements | 10. Securities Registrations and Sales Agreements January 2021 Offering On January 7, 2021, the Company entered into a purchase agreement with certain institutional and accredited investors for the sale of an aggregate of 1,303,408 shares of the Company’s common stock, at a purchase price of $6.675 per share. Under the purchase agreement, subject to certain exceptions, the Company is prohibited from effecting or entering into an agreement to effect any “variable rate transactions” as defined in the purchase agreement for a period of five years following the closing of the offering. In connection with the offering, pursuant to the purchase agreement we reimbursed Lincoln Park Capital Fund, LLC, as the lead investor (“Lincoln Park”), an aggregate of $100,000 for expenses incurred in connection with the offering, including any due diligence expenses and legal fees. Furthermore, pursuant to the purchase agreement, we have granted Lincoln Park certain rights to participate at fair value with other investors in up to 50% of the amount of any future offerings of common stock or securities exercisable for or convertible into common stock that the Company seeks to complete within one year after the closing of the offering, other than a firm commitment public offering. The net proceeds to the Company from the offering, after deducting Lincoln Park’s expenses and other estimated offering expenses payable by the Company were approximately $8.5 million. The shares sold in the offering were offered and sold by the Company directly to the investors, without a placement agent, underwriter, broker or dealer, pursuant to an effective shelf registration statement on Form S-3 (File No. 333-237844) declared effective by the SEC on May 18, 2020, and the base prospectus contained therein. The offering closed on January 11, 2021. February 2021 Offering On February 10, 2021, the Company entered into an underwriting agreement with Guggenheim Securities, LLC, as representative of several underwriters, for the public offering of 1,666,667 shares of the Company’s common stock, at a public offering price of $15.00 per share. Under the terms of the underwriting agreement, the Company granted the underwriters an option, exercisable for 30 days, to purchase up to an additional 250,000 shares of common stock at the same price. The option was exercised prior to closing. In connection with the offering, the Company paid the underwriters a cash fee equal to 6% of the gross proceeds in the offering and $100,000 in legal fees and expenses. The net proceeds to the Company from the offering, including exercise of the underwriters’ option, were approximately $26.7 million, after deducting fees and estimated offering expenses payable by the Company. The offering was made pursuant to a registration statement (No. 333-237844) on Form S-3, which was initially filed by the Company with the SEC on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020. The offering closed on February 16, 2021. August 2021 Equity Distribution Agreement On August 20, 2021, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler”) under which the Company may offer and sell, from time to time at its sole discretion, shares of the Company’s common stock, with aggregate gross sales proceeds of up to $25.0 million through an “at the market” equity offering program under which Piper Sandler is the sales agent. Under the Equity Distribution Agreement, the Company has the right to set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitations on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Equity Distribution Agreement, Piper Sandler may sell the shares by methods deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made through The Nasdaq Capital Market or any other trading market for our common stock. The Equity Distribution Agreement provides that Piper Sandler is entitled to compensation for its services equal to 3.0% of the gross proceeds of any shares of common stock sold through Piper Sandler under the Equity Distribution Agreement. The Company has no obligation to sell any shares under the Equity Distribution Agreement, and may at any time suspend solicitation and offers under the Equity Distribution Agreement. Through September 30, 2022, the Company sold 109,523 shares under the agreement at a weighted average price of $5.32 per share. Net proceeds after commissions and offering expenses were approximately $0.5 million. There were no shares sold by the Company under the agreement during the nine months ended September 30, 2022. The shares are issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-237844). The Company filed a prospectus supplement, dated August 20, 2021 with the Securities and Exchange Commission in connection with the offer and sale of the shares pursuant to the Equity Distribution Agreement. September 2021 Offering On September 23, 2021, the Company entered into an underwriting agreement with Guggenheim Securities, LLC, as representative of several underwriters, for the public offering of 5,000,000 shares of the Company’s common stock, at a public offering price of $4.20 per share. Under the terms of the underwriting agreement, the Company granted the underwriters an option, exercisable for 30 days, to purchase up to an additional 750,000 shares of common stock at the same price. The option was not exercised. In connection with the offering, the Company paid the underwriters a cash fee equal to 6% of the gross proceeds in the offering and $100,000 in legal fees and expenses. The net proceeds to the Company from the offering, including exercise of the underwriters’ option, were approximately $19.5 million, after deducting fees and estimated offering expenses payable by the Company. The offering was made pursuant to a registration statement (No. 333-237844) on Form S-3, which was initially filed by the Company with the SEC on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020. The offering closed on September 28, 2021. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021, the consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2022 and 2021 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021 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 September 30, 2022, the results of its operations for the three and nine months ended September 30, 2022 and 2021, and its cash flows for the nine months ended September 30, 2022 and 2021. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2022 and 2021 are unaudited. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, 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, 2021 included in the Company’s annual report on Form 10-K filed with the SEC on March 21, 2022. 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 |
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, 2021 included in the Company’s annual report on Form 10-K filed with the SEC on March 21, 2022. 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 guidance is not expected to have a material effect on the Company. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue. | |
Schedule of recognized revenue under license and collaboration agreements | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Symbio Upfront license fee recognition over time $ 57,000 $ 57,000 $ 170,000 $ 170,000 |
Schedule of deferred revenue | Symbio Upfront Payment Deferred balance at December 31, 2021 $ 3,469,000 Recognition to revenue (170,000) Deferred balance at September 30, 2022 $ 3,299,000 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share of Common Stock | |
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | September 30, 2022 2021 Warrants 491,586 496,586 Stock options 1,178,498 438,006 1,670,084 934,592 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Warrants | |
Schedule of warrants outstanding and warrant activity | Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants September 30, Description Classification Price Date 2021 Issued Exercised Expired 2022 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 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 244,500 — — — 244,500 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 — — — 29,968 500,108 — — — 500,108 |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Detail | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2022 2021 Research and development $ 411,000 $ 15,000 Manufacturing 202,000 29,000 Insurance 194,000 253,000 Other 303,000 35,000 $ 1,110,000 $ 332,000 |
Schedule of property and equipment | September 30, December 31, 2022 2021 Property and equipment $ 70,000 $ 70,000 Accumulated depreciation (42,000) (32,000) $ 28,000 $ 38,000 |
Schedule of accrued expenses and other current liabilities | September 30, December 31, 2022 2021 Research and development $ 2,122,000 $ 1,759,000 Employee compensation 1,009,000 1,217,000 Professional fees 219,000 156,000 $ 3,350,000 $ 3,132,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 General and administrative $ 119,000 $ 153,000 $ 377,000 $ 270,000 Research and development 170,000 29,000 448,000 45,000 $ 289,000 $ 182,000 $ 825,000 $ 315,000 |
Schedule of stock option activity | Options Outstanding Weighted Weighted- Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term (in years) Value Balance, December 31, 2021 452,999 $ 20.71 9.42 $ — Authorized — Granted 824,165 $ 1.55 9.60 — Exercised — $ — — $ — Forfeitures/adjustments (98,666) $ 1.19 — Balance, September 30, 2022 1,178,498 $ 8.69 9.29 $ — Exercisable at September 30, 2022 202,690 $ 39.45 8.50 $ — |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Nine months ended September 30, 2022 2021 Risk-free interest rate 2.45 % 0.89 % Expected volatility 121.72 % 133.83 % Expected term 5.70 years 5.93 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 1.32 $ 4.59 |
Nature of Business (Details)
Nature of Business (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
May 20, 2021 $ / shares shares | Sep. 30, 2022 USD ($) Program $ / shares shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) Program $ / shares shares | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) $ / shares shares | May 19, 2021 shares | Dec. 31, 2020 USD ($) | |
Nature of Business | ||||||||
Number of clinical programs (in programs) | Program | 2 | 2 | ||||||
Reverse stock split ratio | 0.067 | |||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Common stock authorized (in shares) | shares | 125,000,000 | 125,000,000 | 125,000,000 | 125,000,000 | 250,000,000 | |||
Net loss | $ (5,398) | $ (3,453) | $ (13,544) | $ (12,399) | ||||
Accumulated deficit | 458,263 | 458,263 | $ 444,719 | |||||
Cash and cash equivalents | $ 42,613 | $ 59,378 | $ 42,613 | $ 59,378 | $ 55,070 | $ 19,025 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - segment | 9 Months Ended | |
May 20, 2021 | Sep. 30, 2022 | |
Summary of Significant Accounting Policies | ||
Number of Operating Segments | 1 | |
Reverse stock split | one-for-fifteen |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue | ||||
Revenue | $ 57 | $ 57 | $ 170 | $ 170 |
Activity in deferred revenue | ||||
Balance at the beginning of the period | 226 | |||
Balance at the end of the period | 226 | 226 | ||
SymBio | ||||
Activity in deferred revenue | ||||
Balance at the beginning of the period | 3,469 | |||
Deferred revenue recognized | (170) | |||
Balance at the end of the period | 3,299 | 3,299 | ||
License and collaboration agreements | SymBio | ||||
Revenue | ||||
Revenue | $ 57 | $ 57 | $ 170 | $ 170 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
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 | 1,670,084 | 934,592 |
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 | 491,586 | 496,586 |
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 | 1,178,498 | 438,006 |
Warrants (Details)
Warrants (Details) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 500,108 | 500,108 |
Warrant exercise price range one [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 2.25 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 26 | 26 |
Warrant exercise price range two [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 24 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 26,189 | 26,189 |
Warrant exercise price range three [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 2.25 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 3,522 | 3,522 |
Warrant exercise price range four [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 24 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 120,407 | 120,407 |
Warrant exercise price range five [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 2.25 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 4,974 | 4,974 |
Warrant exercise price range six [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 30 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 7,306 | 7,306 |
Warrant exercise price range seven [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 3 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 244,500 | 244,500 |
Warrant exercise price range eight [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 6.54375 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 16,953 | 16,953 |
Warrant exercise price range nine [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 6.75450 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 46,263 | 46,263 |
Warrant exercise price range ten [member] | ||
Warrants | ||
Warrant exercise price (in dollars per share) | $ 6.77850 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 29,968 | 29,968 |
Balance Sheet Detail - Prepaid
Balance Sheet Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid expenses and other current assets: | ||
Research and development | $ 411 | $ 15 |
Manufacturing | 202 | 29 |
Insurance | 194 | 253 |
Other | 303 | 35 |
Prepaid expenses and other current assets | $ 1,110 | $ 332 |
Balance Sheet Detail - Property
Balance Sheet Detail - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property and Equipment | ||
Property and equipment | $ 70 | $ 70 |
Accumulated depreciation | (42) | (32) |
Property and equipment, net | $ 28 | $ 38 |
Balance Sheet Detail - Accrued
Balance Sheet Detail - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Detail | ||
Research and development | $ 2,122 | $ 1,759 |
Employee compensation | 1,009 | 1,217 |
Professional fees | 219 | 156 |
Accrued expenses and other current liabilities | $ 3,350 | $ 3,132 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy Table (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | |
Liabilities measured at fair value | ||||
Change in fair value of warrant liability | $ 530,000 | $ 321,000 | ||
Recurring basis | ||||
Liabilities measured at fair value | ||||
Assets, Fair Value Disclosure | $ 0 | $ 0 | ||
Financial liabilities | $ 0 | $ 0 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | Aug. 18, 2022 | Jun. 17, 2019 | Sep. 30, 2022 |
2018 Plan | |||
Stock-Based Compensation | |||
Shares authorized (in shares) | 26,823 | ||
Additional shares authorized (in shares) | 39,300 | ||
2021 Incentive Plan | |||
Stock-Based Compensation | |||
Shares authorized (in shares) | 1,300,000 | ||
Common Stock available for future issuance (in shares) | 1,906,192 | ||
2021 Incentive Plan | Common Stock | |||
Stock-Based Compensation | |||
Additional shares authorized (in shares) | 2,000,000 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation | ||||
Net tax benefits related to the stock-based compensation costs | $ 0 | |||
Compensation expense | $ 289,000 | $ 182,000 | 825,000 | $ 315,000 |
General and administrative | ||||
Stock-Based Compensation | ||||
Compensation expense | 119,000 | 153,000 | 377,000 | 270,000 |
Research and development | ||||
Stock-Based Compensation | ||||
Compensation expense | $ 170,000 | $ 29,000 | $ 448,000 | $ 45,000 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Activity (Details) - Stock options - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Shares Available for Grant | ||
Granted (in shares) | (824,165) | |
Forfeitures/adjustments (in shares) | (98,666) | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 452,999 | |
Granted (in shares) | 824,165 | |
Forfeitures/adjustments (in shares) | (98,666) | |
Balance at the end of the period (in shares) | 1,178,498 | 452,999 |
Exercisable at the end of the period (in shares) | 202,690 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 20.71 | |
Granted (in dollars per share) | 1.55 | |
Forfeitures (in dollars per share) | 1.19 | |
Balance at the end of the period (in dollars per share) | 8.69 | $ 20.71 |
Exercisable at the end of the period (in dollars per share) | $ 39.45 | |
Additional Disclosures | ||
Weighted average remaining contractual term | 9 years 3 months 14 days | 9 years 5 months 1 day |
Weighted average remaining contractual term of options granted | 9 years 7 months 6 days | |
Weighted average remaining contractual term of options exercisable | 8 years 6 months |
Stock-Based Compensation - Op_2
Stock-Based Compensation - Options Unrecognized Compensation Expense (Details) - Stock options | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 1,717,000 |
Weighted-average period for recognizing unrecognized compensation expense (in years) | 1 year 11 months 8 days |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Assumptions used | ||
Expected dividend yield (as a percent) | 0% | |
Stock options | ||
Assumptions used | ||
Risk-free interest rate (as a percent) | 2.45% | 0.89% |
Expected volatility (as a percent) | 121.72% | 133.83% |
Expected term (in years) | 5 years 8 months 12 days | 5 years 11 months 4 days |
Expected dividend yield (as a percent) | 0% | 0% |
Weighted average grant date fair value (in dollars per share) | $ 1.32 | $ 4.59 |
Stock-Based Compensation - RSUs
Stock-Based Compensation - RSUs, PSUs and SARs (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Jun. 10, 2022 | Feb. 07, 2022 | Aug. 02, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock outstanding (in shares) | 20,925,992 | 20,925,992 | 20,895,563 | |||||
Compensation expense | $ 289,000 | $ 182,000 | $ 825,000 | $ 315,000 | ||||
Employee | 2021 service-based RSUs | 2021 Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Nonoption units granted | 104,700 | |||||||
Grant date fair value per unit | $ 5.19 | |||||||
Forfeitures | 13,400 | |||||||
Vesting RSU | 30,429 | |||||||
Employee | 2022 service-based RSUs | 2021 Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Nonoption units granted | 24,200 | 148,343 | ||||||
Grant date fair value per unit | $ 1.33 | $ 1.82 | ||||||
Forfeitures | 17,633 | |||||||
Unrecognized compensation cost related to awards other than options | $ 505,000 | $ 505,000 | ||||||
Employee | Vesting Percentage One | 2021 service-based RSUs | 2021 Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 33% | |||||||
Employee | Vesting Percentage One | 2022 service-based RSUs | 2021 Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 33% | 33% | ||||||
Employee | Vesting Percentage Two | 2021 service-based RSUs | 2021 Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 34% | |||||||
Employee | Vesting Percentage Two | 2022 service-based RSUs | 2021 Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting (Percentage) | 34% | 34% |
Research Agreements (Details)
Research Agreements (Details) | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
License | |
Research Agreements | |
Revenue | $ 0 |
Securities Registrations and _2
Securities Registrations and Sales Agreements (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 10 Months Ended | |||||
Sep. 23, 2021 | Aug. 20, 2021 | Feb. 10, 2021 | Jan. 07, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2022 | |
Proceeds from issuance of common stock | $ 55,091 | ||||||
Lincoln Park Capital Fund, LLC | The Offering | |||||||
Expense reimbursement | $ 100 | ||||||
Percentage rights to participate | 50% | ||||||
Threshold period for exercise or conversion of stock | one year | ||||||
Institutional Investors | The Offering | |||||||
Issuance of common stock, net (in shares) | 1,303,408 | ||||||
Issue price (in dollars per share) | $ 6.675 | ||||||
Proceeds from issuance of common stock | $ 8,500 | ||||||
Guggenheim Securities, LLC | The Offering | |||||||
Issuance of common stock, net (in shares) | 5,000,000 | ||||||
Price per share (in dollars per share) | $ 4.20 | ||||||
Underwriters option exercisable term | 30 days | ||||||
Proceeds from issuance of common stock | $ 19,500 | ||||||
Cash fee | 6% | ||||||
Legal fees and expenses | $ 100 | ||||||
Guggenheim Securities, LLC | Over-allotment | |||||||
Issuance of common stock, net (in shares) | 1,666,667 | ||||||
Issue price (in dollars per share) | $ 15 | ||||||
Threshold period for exercise or conversion of stock | 30 days | ||||||
Proceeds from issuance of common stock | $ 26,700 | ||||||
Additional shares agreed to issue | 250,000 | ||||||
Cash fee | 6% | ||||||
Legal fees and expenses | $ 100 | ||||||
Piper Sandler & Co | |||||||
Issuance of common stock, net (in shares) | 0 | 109,523 | |||||
Proceeds from issuance of common stock | $ 25,000 | $ 500 | |||||
Percentage of gross proceeds of shares of common stock sold | 3% | ||||||
Weighted Average Price | $ 5.32 | ||||||
Maximum | Guggenheim Securities, LLC | Over-allotment | |||||||
Issuance of common stock, net (in shares) | 750,000 |