Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 01, 2023 | Jun. 30, 2022 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 27.5 | ||
Entity Common Stock, Shares Outstanding | 20,969,559 | ||
Title of 12(b) Security | Common Stock, par value $.01 per share | ||
Trading Symbol | ONTX | ||
Security Exchange Name | NASDAQ | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Entity Central Index Key | 0001130598 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 38,757,000 | $ 55,070,000 |
Receivables | 29,000 | 28,000 |
Prepaid expenses and other current assets | 561,000 | 332,000 |
Total current assets | 39,347,000 | 55,430,000 |
Property and equipment, net | 24,000 | 38,000 |
Other non-current assets | 1,000 | 10,000 |
Total assets | 39,372,000 | 55,478,000 |
Current liabilities: | ||
Accounts payable | 3,860,000 | 2,757,000 |
Accrued expenses and other current liabilities | 3,960,000 | 3,132,000 |
Deferred revenue | 226,000 | 226,000 |
Total current liabilities | 8,046,000 | 6,115,000 |
Deferred revenue, non-current | 3,017,000 | 3,243,000 |
Total liabilities | 11,063,000 | 9,358,000 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 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 December 31, 2022 and December 31, 2021, respectively | 209,000 | 209,000 |
Additional paid in capital | 491,816,000 | 490,644,000 |
Accumulated deficit | (463,683,000) | (444,719,000) |
Accumulated other comprehensive loss | (33,000) | (14,000) |
Total stockholders' equity | 28,309,000 | 46,120,000 |
Total liabilities and stockholders' equity | $ 39,372,000 | $ 55,478,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Statements of Operations | ||
Revenue | $ 226,000 | $ 226,000 |
Operating expenses: | ||
General and administrative | 8,447,000 | 9,425,000 |
Research and development | 11,406,000 | 7,297,000 |
Total operating expenses | 19,853,000 | 16,722,000 |
Loss from operations | (19,627,000) | (16,496,000) |
Change in fair value of warrant liability | 321,000 | |
Other income, net | 663,000 | 12,000 |
Net loss | $ (18,964,000) | $ (16,163,000) |
Net loss per share, basic (in dollars per share) | $ (0.91) | $ (0.96) |
Net loss per share, diluted (in dollars per share) | $ (0.91) | $ (0.96) |
Basic weighted average shares outstanding (in shares) | 20,908,235 | 16,832,198 |
Diluted weighted average shares outstanding (in shares) | 20,908,235 | 16,832,198 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Statements of Comprehensive Loss | ||
Net loss | $ (18,964,000) | $ (16,163,000) |
Other comprehensive loss, net of tax: | ||
Foreign currency translation adjustments, net | (19,000) | (28,000) |
Other comprehensive loss, net of tax | (19,000) | (28,000) |
Comprehensive loss | $ (18,983,000) | $ (16,191,000) |
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, 2020 | $ 124,000 | $ 434,593,000 | $ (428,556,000) | $ 14,000 | $ 6,175,000 |
Balance (in shares) at Dec. 31, 2020 | 12,396,219 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (16,163,000) | (16,163,000) | |||
Other comprehensive loss | (28,000) | (28,000) | |||
Stock-based compensation | 576,000 | 576,000 | |||
Exercise of stock options | 24,000 | 24,000 | |||
Exercise of stock options (in shares) | 4,642 | ||||
Shares issued in connection with reverse stock split | 104 | ||||
Issuance of common stock, net | $ 83,000 | 54,958,000 | 55,041,000 | ||
Issuance of common stock, net (in shares) | 8,329,598 | ||||
Issuance of common stock upon exercise of warrants | $ 2,000 | 493,000 | 495,000 | ||
Issuance of common stock upon exercise of warrants (in shares) | 165,000 | ||||
Balance at Dec. 31, 2021 | $ 209,000 | 490,644,000 | (444,719,000) | (14,000) | $ 46,120,000 |
Balance (in shares) at Dec. 31, 2021 | 20,895,563 | 20,895,563 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Net loss | (18,964,000) | $ (18,964,000) | |||
Other comprehensive loss | (19,000) | (19,000) | |||
Stock-based compensation | 1,172,000 | 1,172,000 | |||
Shares issued for vested restricted stock units, shares | 30,429 | ||||
Balance at Dec. 31, 2022 | $ 209,000 | $ 491,816,000 | $ (463,683,000) | $ (33,000) | $ 28,309,000 |
Balance (in shares) at Dec. 31, 2022 | 20,925,992 | 20,925,992 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | ||
Net loss | $ (18,964,000) | $ (16,163,000) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 14,000 | 14,000 |
Change in fair value of warrant liabilities | (321,000) | |
Stock compensation expense | 1,172,000 | 576,000 |
Changes in assets and liabilities: | ||
Receivables | (1,000) | 9,000 |
Prepaid expenses and other current assets | (229,000) | 530,000 |
Other assets | 9,000 | |
Accounts payable | 1,103,000 | (2,076,000) |
Accrued expenses and other current liabilities | 828,000 | (1,830,000) |
Deferred revenue | (226,000) | (226,000) |
Net cash used in operating activities | (16,294,000) | (19,487,000) |
Financing activities: | ||
Proceeds from the sale of common stock and warrants, net of costs | 55,041,000 | |
Proceeds from the exercise of common warrants | 495,000 | |
Proceeds from the exercise of stock options | 24,000 | |
Net cash provided by financing activities | 55,560,000 | |
Effect of foreign currency translation on cash | (19,000) | (28,000) |
Net (decrease) increase in cash and cash equivalents | (16,313,000) | 36,045,000 |
Cash and cash equivalents at beginning of period | 55,070,000 | 19,025,000 |
Cash and cash equivalents at end of period | $ 38,757,000 | $ 55,070,000 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 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 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 has the following two clinical-stage programs: 1. narazaciclib (ON 123300), a multi-kinase inhibitor 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. On May 20, 2021, the Company amended its certificate of incorporation to effect a one-for-fifteen one-for-fifteen 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 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. On September 28, 2021, the Company closed on an offering of common stock. The Company issued 5,000,000 shares of common stock and net proceeds were approximately $19.5 million. On August 20, 2021, the Company entered into an at-the-market equity distribution agreement for the sale of up to $25.0 million of common stock. Through September 30, 2021, 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 other sales during the years ended December 31, 2022 and 2021. The Company has incurred recurring operating losses since inception. For the year ended December 31, 2022, the Company incurred a net loss of $18,964,000 and as of December 31, 2022 the Company had generated an accumulated deficit of $463,683,000. 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 December 31, 2022, the Company had cash and cash equivalents of $38,757,000. The Company believes that its cash and cash equivalents will be sufficient to fund its ongoing trials and business operations into the first quarter of 2024; however, based on current projections, the Company does not have sufficient cash and cash equivalents as of the date of this Annual Report on Form 10-K to support its operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through the one year period after the date that the financial statements are issued. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, management plans to explore 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 failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on the Company’s business, results of operations, and financial condition. Accordingly, management has concluded that substantial doubt exists with respect to the Company's ability to continue as a going concern within one year after the date that these financial statements are issued. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (GAAP). 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. All common stock, equity, share and per share amounts 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. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, other comprehensive income and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to clinical trial accruals, warrant liability, and allocation of consideration for revenue recognition. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance sheet risk of loss At December 31, 2022 the Company had $38,522,000 of its cash and cash equivalents in a Morgan Stanley Institutional Liquidity Fund. The fund is a AAA rated money market fund that invests in a portfolio of liquid, high-quality debt securities issued by the U.S. government. The fund resides in a custodial account held by U.S. Bank for which SVB Asset Management is the advisor (see Note: 16, Subsequent Events). Cash and Cash Equivalents The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. During the year ended December 31, 2022, the Company received $651,000 of interest income primarily from a money market mutual fund that invests primarily in U.S. government obligations. The interest income is included in Other income, net in the Statement of Operations. Fair Value of Financial Instruments 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 8, Fair Value Measurements. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets: Estimated Useful Life Lab equipment 5- 6 years Software 3 years Computer and office equipment 5- 6 years Leasehold improvements Shorter of the lease term or estimated useful life Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized. The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value, which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses have been recorded through December 31, 2022. Warrant Accounting 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 The Company’s warrants that are classified as liabilities are recorded at fair value. The warrants are subject to remeasurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the consolidated statements of operations. The warrants are classified as level 3 liabilities and the Company uses the Black-Scholes pricing model to estimate the fair value of the related derivative warrant liability. All of the warrants that were classified as liabilities expired in July 2021. (See Note 8 for a discussion of the fair value hierarchy). Foreign Currency Translation The reporting currency of the Company and its U.S. subsidiaries is the U.S. dollar. The functional currency of the Company’s non-U.S. subsidiary is the local currency. Assets and liabilities of the foreign subsidiary are translated into U.S. dollars based on exchange rates at the end of the period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive income. Gains and losses resulting from foreign currency transactions are reflected within the Company’s results of operations. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company derives revenue from its collaboration and licensing agreements. License, Collaboration and Other Revenues The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success. Licensing of Intellectual Property: Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in their period of adjustment. Manufacturing supply services. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements. Research and Development Expenses Research and development costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Leases The Company accounts for leases in accordance with Accounting Standards Codification Topic 842, Leases Right of Use (ROU) Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short-term leases (term of 12 months or less) on the balance sheet, and not separating lease and non-lease components. The Company does not have any material lease agreements. Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain research and patent costs, which have been charged to expense in the accompanying statements of operations but have been recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been established against all of the deferred tax assets (see Note 9, Income Taxes), as it is more likely than not that these assets will not be realized given the Company’s history of operating losses. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position. Stock-Based Compensation Expense The Company applies the provisions of FASB Accounting Standards Codification (ASC) Topic 718, Compensation—Stock Compensation Share-based payment transactions with employees are recognized as compensation expense over the requisite service period based on their estimated fair values. ASC 718 also requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the term and expected lives, to estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock compensation in the statement of operations. Clinical Trial Expense Accruals As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2022 and 2021, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period, excluding the dilutive effects of stock options and warrants. Diluted net loss per share of common stock is computed by dividing the net loss applicable to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period plus the potential dilutive effects of stock options and warrants outstanding during the period calculated in accordance with the treasury stock method but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of Common Stock for the years ended December 31, 2022 and 2021. 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 fiscal years beginning after December 15, 2022, and interim periods within those years, for companies deemed to be smaller reporting companies as of November 15, 2019, with early adoption permitted. The Company will adopt the guidance effective January 1, 2023. The guidance is not expected to have a material effect on the Company. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property and Equipment | |
Property and Equipment | 3. Property and Equipment Property and equipment and related accumulated depreciation are as follows: December 31, 2022 2021 Computer and office equipment $ 70,000 $ 70,000 Less accumulated depreciation (46,000) (32,000) $ 24,000 $ 38,000 Depreciation and amortization expense was $14,000 and $14,000 for the years ended December 31, 2022 and 2021, respectively. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Warrants | |
Warrants | 4. 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 at December 31, 2021 and 2022, and warrant activity for the year ended December 31, 2022 is as follows (reflects the number of common shares as if the warrants were converted to common stock): Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants December 31, 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 — — (146,596) 353,512 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Net Loss Per Share of Common Stock | |
Net Loss Per Share of Common Stock | 5. Net Loss Per Share of Common Stock The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2022 and 2021: Year ended December 31, 2022 2021 Basic and diluted net loss per share of common stock: Net loss attributable to Onconova Therapeutics, Inc. $ (18,964,000) $ (16,163,000) Weighted average shares of common stock outstanding 20,908,235 16,832,198 Net loss per share of common stock—basic and diluted $ (0.91) $ (0.96) The following potentially dilutive securities outstanding at December 31, 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): December 31, 2022 2021 Warrants 344,990 491,586 Stock options 1,397,763 452,999 1,742,753 944,585 |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2022 | |
Revenue. | |
Revenue | 6. Revenue The Company recognized revenue under its license and collaboration agreement with SymBio as follows (See Note 14): Year ended December 31, 2022 2021 Symbio Upfront license fee recognition over time $ 226,000 $ 226,000 Deferred revenue is as follows: Symbio Upfront Payment Deferred balance at December 31, 2021 $ 3,469,000 Recognition to revenue (226,000) Deferred balance at December 31, 2022 $ 3,243,000 |
Balance Sheet Detail
Balance Sheet Detail | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Detail | |
Balance Sheet Detail | 7. Balance Sheet Detail Prepaid expenses and other current assets are as follows: December 31, 2022 2021 Research and development $ 233,000 $ 15,000 Manufacturing 97,000 29,000 Insurance 191,000 253,000 Other 40,000 35,000 $ 561,000 $ 332,000 Accrued expenses and other current liabilities are as follows: December 31, 2022 2021 Research and development $ 2,593,000 $ 1,759,000 Employee compensation 1,187,000 1,217,000 Professional fees 180,000 156,000 $ 3,960,000 $ 3,132,000 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 8. Fair Value Measurements At both December 31, 2022 and 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 year ended December 31, 2021, there was a decrease in the fair value of the warrant liability of $321,000. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | 9. Income Taxes The Company accounts for income taxes under FASB ASC 740 (ASC 740). Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Income taxes have been based on the following income (loss) before income tax expense: December 31, 2022 2021 Domestic $ (18,977,000) $ (16,153,000) Foreign 13,000 (10,000) $ (18,964,000) $ (16,163,000) As of December 31, 2022, the Company had federal net operating loss (NOL) carry forwards of $298,100,000, state NOL carry forwards of $257,800,000, federal research and development tax credit carry forwards of $89,700,000, and state research and development tax credit carry forwards of $1,100,000, which may be available to reduce future taxable income. There are $208,400,000 of federal NOLs that were generated in tax periods prior to 2018 that will begin to expire at various dates starting in 2023 and ending in 2037. The NOLs that were generated in 2018 through 2022 of $89,700,000 will carry forward indefinitely and not expire pursuant to changes in tax laws but will be limited in a single tax year to 80 percent of federal taxable income. The state NOL carry forwards will begin to expire at various dates starting in 2025. The NOL carry forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. The Company believes such a change occurred and may impact available net operating losses and carry over research credits generated. The Company has not performed any detailed analysis as it expects these to expire before utilization and has provided for a full valuation allowance. The Company will complete a full Section 382 and 383 analysis prior to any utilization of any NOL and tax credit carry forwards. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. As result of changes made by the Tax Cuts and Jobs Act of 2017, that became effective as of January 1, 2022, the company is now required to capitalize for tax purposes certain research and development expenses, and amortize domestic expenses over a 5 year period and foreign expenses over a 15 year period, resulting in a deferred tax asset for the capitalized amounts. The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. The Company recognized no material adjustment for unrecognized income tax benefits. Through December 31, 2022, the Company had no unrecognized tax benefits or related interest and penalties accrued. The principal components of the Company’s deferred tax assets are as follows: December 31, 2022 2021 Deferred tax assets: Net operating loss carryovers $ 73,394,000 $ 81,468,000 R&D tax credits 90,522,000 88,721,000 Non-qualified stock options 2,135,000 2,194,000 Deferred revenue 809,000 1,002,000 Charitable contributions — 4,000 Accrued expenses 395,000 447,000 Capitalized research and development costs 2,867,000 — Stock Appreciation Rights 12,000 19,000 Deferred tax assets 170,134,000 173,855,000 Deferred tax liabilities: Fixed Assets — (1,000) Deferred tax liabilities — (1,000) Less valuation allowance (170,134,000) (173,854,000) Net deferred tax assets $ — $ — ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its deferred tax assets at December 31, 2022. The Company experienced a net change in valuation allowance of $3,720,000 and $5,510,000 for the years ended December 31, 2022 and 2021, respectively. A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: December 31, 2022 2021 Federal income tax expense at statutory rate 21.0 % 21.0 % Permanent items — 0.4 State income tax, net of federal benefit 1.3 8.0 Tax credits 9.5 7.4 Change in valuation allowance 19.6 (34.1) Deferred tax adjustment (0.2) (2.6) State tax rate change (50.2) — Other (1.0) (0.1) Effective income tax rate — % — % |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. 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 2018 Plan) allowed for an additional 39,300 shares of the Company’s common stock that may be issued under the Amended 2018 Plan with respect to awards made on and after June 17, 2019. The 2021 Incentive Compensation Plan (the 2021 Plan) was 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 2,000,000. At December 31, 2022, there were 1,711,127 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 years ended December 31, 2022 and 2021: Year Ended December 31, 2022 2021 General and administrative $ 538,000 $ 490,000 Research and development 617,000 86,000 $ 1,155,000 $ 576,000 A summary of stock option activity for the twelve months ended December 31, 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 $ — Granted 1,044,165 $ 1.37 9.48 — Exercised — $ — — $ — Forfeitures/adjustments (99,401) $ 8.77 8.77 Balance, December 31, 2022 1,397,763 $ 7.15 9.18 $ — Exercisable at December 31, 2022 232,488 $ 33.35 8.28 $ — 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. 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 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 December 31, 2022, there was $1,586,000 of unrecognized compensation expense related to the unvested stock options which is expected to be recognized over a weighted-average period of approximately 1.52 years. The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following: Year ended December 31, 2022 2021 Risk-free interest rate 2.65 % 0.89 % Expected volatility 121.11 % 133.77 % Expected term 5.77 years 5.93 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 1.19 $ 4.60 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 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 on the third anniversary of the date of grant. During the year ended December 31, 2022 there were no vesting events, forfeitures, expirations, or cancelations of the 2022 RSUs. At December 31, 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 as of and for the years ended December 31, 2022 and 2021. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2022 | |
Employee Benefit Plan | |
Employee Benefit Plan | 11. Employee Benefit Plan The Company has a 401(k) Retirement Savings Plan. Employees are eligible to participate in the plan as soon as they join the Company if they are at least 21 years of age and work a minimum of 1,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies Employment agreements The Company has entered into employment agreements with certain of its executives. The agreements provide for, among other things, salary, bonus and severance payments. |
Research Agreements
Research Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Research Agreements | |
Research Agreements | 13. 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 December 31, 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. No sublicense fees were incurred during 2022 or 2021. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2022 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 14. License and Collaboration Agreements SymBio Agreement In July 2011, the Company entered into a license agreement with SymBio Pharmaceuticals Limited (SymBio), which has been subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea. Under the SymBio license agreement, SymBio is obligated to use commercially reasonable efforts to develop and obtain market approval for rigosertib inside the licensed territory and the Company has similar obligations outside of the licensed territory. The Company has also entered into an agreement with SymBio providing for it to supply SymBio with development-stage product. Under the SymBio license agreement, the Company also agreed to supply commercial product to SymBio under specified terms that will be included in a commercial supply agreement to be negotiated prior to the first commercial sale of rigosertib. The supply of development-stage product and the supply of commercial product will be at the Company’s cost plus a defined profit margin. Sales of development-stage product have been de minimis. The Company has additionally granted SymBio a right of first negotiation to license or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertib in the licensed territory. Under the terms of the SymBio license agreement, the Company received an upfront payment of $7,500,000 in 2011. In addition, the Company could receive regulatory, development and sales-based milestone payments as well as royalty payments at percentage rates ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio. Royalties will be payable under the SymBio agreement on a country-by-country basis in the licensed territory, until the later of the expiration of marketing exclusivity in those countries, a specified period of time after first commercial sale of rigosertib in such country, or the expiration of all valid claims of the licensed patents covering rigosertib or the manufacture or use of rigosertib in such country. If no valid claim exists covering the composition of matter of rigosertib or the use of or treatment with rigosertib in a particular country before the expiration of the royalty term, and specified competing products achieve a specified market share percentage in such country, SymBio’s obligation to pay the Company royalties will continue at a reduced royalty rate until the end of the royalty term. In addition, the applicable royalties payable to the Company may be reduced if SymBio is required to pay royalties to third-parties for licenses to intellectual property rights necessary to develop, use, manufacture or commercialize rigosertib in the licensed territory. The license agreement with SymBio will remain in effect until the expiration of the royalty term. However, the SymBio license agreement may be terminated earlier due to the uncured material breach or bankruptcy of a party, or force majeure. If SymBio terminates the license agreement in these circumstances, its licenses to rigosertib will survive, subject to SymBio’s milestone and royalty obligations, which SymBio may elect to defer and offset against any damages that may be determined to be due from the Company. In addition, the Company may terminate the license agreement in the event that SymBio brings a challenge against it in relation to the licensed patents, and SymBio may terminate the license agreement without cause by providing the Company with written notice within a specified period of time in advance of termination. The Company assessed the SymBio arrangement in accordance with ASC 606 and determined that its performance obligations under the SymBio agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib, the research and development services to be provided by the Company and its obligation to serve on a joint committee. The Company concluded that the license was not distinct since it was of no benefit to SymBio without the ongoing research and development services and that, as such, the license and the research and development services should be bundled as a single performance obligation. Since the provision of the license and research and development services are considered a single performance obligation, the $7,500,000 upfront payment is being recognized as revenue ratably through December 2037, the expected period over which the Company expects the research and development services to be performed. SymBio’s purchases of rigosertib as development-stage product or for commercial requirements represent options under the agreement and revenues are therefore recognized when control of the product is transferred, which is typically when shipped. If SymBio orders the supplies from the Company, the Company expects the pricing for this supply to equal its third-party manufacturing cost plus a pre-negotiated percentage, which will not result in a significant incremental discount to market rates. In January 2018, the agreement was amended to provide SymBio a discount of 35% on future purchases, limited to a cumulative total amount of $300,000. HanX Narazaciclib (ON 123300) Agreement In December 2017, the Company entered into a license and collaboration agreement with HanX Biopharmaceuticals, Inc. (HanX), a company focused on development of novel oncology products, for the further development, registration and commercialization of narazaciclib in Greater China. Narazaciclib is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. The key feature of the collaboration was that HanX provided all funding required for the Chinese IND enabling studies necessary in order to seek IND approval by the National Medical Products Administration (Chinese FDA). The Chinese IND was approved in January 2020. The Company and HanX also intended for these studies underlying the Chinese IND approval, to meet the US FDA standards for IND approval. Accordingly, such studies were used by the Company for an IND filing with the US FDA in November 2020. In September 2020, a Phase 1 Study with narazaciclib in cancer patients was initiated in China. The Company maintains global rights to the study and study data outside of China. The US FDA Study May Proceed letter was issued in December 2020. Enrollment into the US phase 1 study (Study 19-01) commenced in May 2021. Pursuant to the agreement, the Company received a $450,000 upfront payment on April 11, 2018. If the compound receives regulatory approval and is commercialized, the Company would receive regulatory and commercial milestone payments, as well as royalties on sales in the Greater China territory. The Company assessed the HanX arrangement for revenue recognition in accordance with ASC 606 and determined that the license was distinct and that control of the license had been transferred during the first quarter of 2018. As such, the Company recognized the $450,000 allocated to the license at that time. Pint Agreement On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the Pint License Agreement) and a Securities Purchase Agreement (the Pint Securities Purchase Agreement) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as Pint). Under the terms of the Pint License 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 (the Pint Licensed Product) containing rigosertib in all uses of rigosertib in humans in Latin American countries (the Pint Territory, including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela). Pint agreed to make an upfront equity investment in the Company’s common stock. In addition, the Company could receive additional regulatory, development and sales-based milestone payments, an additional equity investment, as well as tiered, double digit royalties based on net aggregate net sales in the Pint Territory. Pint and the Company have also agreed to enter into a supply agreement providing for Pint purchasing rigosertib and the Pint Licensed Product from the Company within 90 days of FDA approval of an NDA for the Pint Licensed Product. Pint may terminate the Pint License Agreement in whole (but not in part) at any time upon 45 days’ prior written notice. The Pint License Agreement also contains certain provisions for termination by either party in the event of breach of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party. Under the terms of the Pint Securities Purchase Agreement, Pint agreed to make an upfront equity investment in the Company at a specified premium to the Company’s share price. Pursuant to the Pint Securities Purchase Agreement, closing of the upfront equity investment occurred on April 4, 2018 and Pint purchased 3,631 shares of common stock for $1,250,000. The total amount of the premium was $319,000 and this amount was allocated to the license. In addition, under the Pint Securities Purchase Agreement, if the FDA approves the NDA for the Pint Licensed Product, Pint will reimburse the Company for certain research and development expenses. Half of the reimbursement amount will be paid in cash, the other half of the amount will be by an equity investment at a premium to the average of the volume weighted average price of common stock for the ten consecutive trading days ended on the day the FDA approves the NDA. Pursuant to the Pint Securities Purchase Agreement, the common stock purchased by Pint is subject to certain lock-up restrictions and Pint is entitled to certain registration and participation rights. The Company assessed the Pint arrangement for revenue recognition in accordance with ASC 606 and determined that the license was distinct and that control of the license had been transferred during the second quarter of 2018. As such, the Company recognized the $319,000 allocated to the license at that time. Knight Agreement In November 2019, the Company entered into a Distribution, License and Supply Agreement (the Knight License Agreement) with Knight Therapeutics Inc. (Knight). Under the terms of the Knight License Agreement, the Company granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the Knight Licensed Product) containing rigosertib for Canada (and Israel should Knight exercise its option) (the Knight Territory) and in human uses (the Knight Licensed 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 Knight Licensed Field. Knight has also agreed to obtain from the Company all of Knight’s 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. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the Knight Licensed Products. In addition, the Company has granted Knight an exclusive right of first refusal with respect to all or any part of the Knight Territory, to store, market, promote, sell, offer for sale and/or distribute any ROFR Products. As used in the Knight License Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed, or controlled by the Company as of the effective date and all improvements thereto. The Company received an upfront payment of $100,000 and is eligible to receive clinical, regulatory and sales-based milestone payments. The Company is also eligible to receive tiered double-digit royalties based on net sales in the Knight Territory. The Knight License Agreement is for a term of 15 years from the launch on a country by country basis in the Knight Territory and contains customary provisions for termination by either party in the event of breach of the Knight License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee. The Company assessed the Knight License Agreement for revenue recognition in accordance with ASC 606 and determined that the license was distinct and that control of the license had been transferred during the fourth quarter of 2019. As such, the Company recognized the $100,000 allocated to the license at that time. Specialised Therapeutics Asia Pte. Ltd. Agreement On December 18, 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 STA’s 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. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the STA Licensed Products. There was an upfront fee of $50,000 and the Company may be entitled to receive clinical, regulatory and sale-based milestone payments. The Company may also be entitled to receive tiered double-digit royalties based on net sales in the Territory. The License Agreement is for a term of 15 years from the launch on a country by country basis in the Territory and contains customary provisions for termination by either party in the event of breach of the License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee. The Company assessed the License Agreement for revenue recognition in accordance with ASC 606 and determined that the license was distinct and that control of the license had been transferred during the fourth quarter of 2019. As such, the Company recognized the $50,000 allocated to the license at that time. |
Securities Registrations and Sa
Securities Registrations and Sales Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Securities Registrations and Sales Agreements | |
Securities Registrations and Sales Agreements | 15. 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 the Company 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, the Company 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 the Company’s 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, 2021, 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 other sales during the years ended December 31, 2022 and 2021. 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. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events Silicon Valley Bank (SVB) was closed on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. At the time of closing, the Company had nearly all of its cash and cash equivalent balances in segregated custodial accounts held by U.S. Bank for which SVB Asset Management is the advisor. The Company’s investment portfolio currently does not contain any securities of SVB. On March 12, 2023, the U.S. Treasury, Federal Reserve, and FDIC announced that SVB depositors would have access to all of their money starting March 13, 2023 and the Company has received such access. The Company does not believe it will be impacted by the closure of SVB and will continue to monitor the situation as it evolves. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (GAAP). 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. All common stock, equity, share and per share amounts 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. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, other comprehensive income and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to clinical trial accruals, warrant liability, and allocation of consideration for revenue recognition. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance sheet risk of loss At December 31, 2022 the Company had $38,522,000 of its cash and cash equivalents in a Morgan Stanley Institutional Liquidity Fund. The fund is a AAA rated money market fund that invests in a portfolio of liquid, high-quality debt securities issued by the U.S. government. The fund resides in a custodial account held by U.S. Bank for which SVB Asset Management is the advisor (see Note: 16, Subsequent Events). |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. During the year ended December 31, 2022, the Company received $651,000 of interest income primarily from a money market mutual fund that invests primarily in U.S. government obligations. The interest income is included in Other income, net in the Statement of Operations. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments 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 8, Fair Value Measurements. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company’s assets: Estimated Useful Life Lab equipment 5- 6 years Software 3 years Computer and office equipment 5- 6 years Leasehold improvements Shorter of the lease term or estimated useful life Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized. The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value, which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses have been recorded through December 31, 2022. |
Warrant Accounting | Warrant Accounting 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 The Company’s warrants that are classified as liabilities are recorded at fair value. The warrants are subject to remeasurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the consolidated statements of operations. The warrants are classified as level 3 liabilities and the Company uses the Black-Scholes pricing model to estimate the fair value of the related derivative warrant liability. All of the warrants that were classified as liabilities expired in July 2021. (See Note 8 for a discussion of the fair value hierarchy). |
Foreign Currency Translation | Foreign Currency Translation The reporting currency of the Company and its U.S. subsidiaries is the U.S. dollar. The functional currency of the Company’s non-U.S. subsidiary is the local currency. Assets and liabilities of the foreign subsidiary are translated into U.S. dollars based on exchange rates at the end of the period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive income. Gains and losses resulting from foreign currency transactions are reflected within the Company’s results of operations. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company derives revenue from its collaboration and licensing agreements. License, Collaboration and Other Revenues The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success. Licensing of Intellectual Property: Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in their period of adjustment. Manufacturing supply services. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements. |
Research and Development Expenses | Research and Development Expenses Research and development costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. |
Leases | Leases The Company accounts for leases in accordance with Accounting Standards Codification Topic 842, Leases Right of Use (ROU) Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short-term leases (term of 12 months or less) on the balance sheet, and not separating lease and non-lease components. The Company does not have any material lease agreements. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain research and patent costs, which have been charged to expense in the accompanying statements of operations but have been recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been established against all of the deferred tax assets (see Note 9, Income Taxes), as it is more likely than not that these assets will not be realized given the Company’s history of operating losses. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company applies the provisions of FASB Accounting Standards Codification (ASC) Topic 718, Compensation—Stock Compensation Share-based payment transactions with employees are recognized as compensation expense over the requisite service period based on their estimated fair values. ASC 718 also requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the term and expected lives, to estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock compensation in the statement of operations. |
Clinical Trial Expense Accruals | Clinical Trial Expense Accruals As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2022 and 2021, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period, excluding the dilutive effects of stock options and warrants. Diluted net loss per share of common stock is computed by dividing the net loss applicable to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period plus the potential dilutive effects of stock options and warrants outstanding during the period calculated in accordance with the treasury stock method but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of Common Stock for the years ended December 31, 2022 and 2021. |
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 fiscal years beginning after December 15, 2022, and interim periods within those years, for companies deemed to be smaller reporting companies as of November 15, 2019, with early adoption permitted. The Company will adopt the guidance effective January 1, 2023. The guidance is not expected to have a material effect on the Company. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of estimated useful lives used to depreciate the Company's assets | Estimated Useful Life Lab equipment 5- 6 years Software 3 years Computer and office equipment 5- 6 years Leasehold improvements Shorter of the lease term or estimated useful life |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property and Equipment | |
Schedule of property and equipment | December 31, 2022 2021 Computer and office equipment $ 70,000 $ 70,000 Less accumulated depreciation (46,000) (32,000) $ 24,000 $ 38,000 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Warrants | |
Schedule of warrants outstanding and warrant activity | Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants December 31, 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 — — (146,596) 353,512 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Net Loss Per Share of Common Stock | |
Schedule of computation of basic and diluted earnings per share | Year ended December 31, 2022 2021 Basic and diluted net loss per share of common stock: Net loss attributable to Onconova Therapeutics, Inc. $ (18,964,000) $ (16,163,000) Weighted average shares of common stock outstanding 20,908,235 16,832,198 Net loss per share of common stock—basic and diluted $ (0.91) $ (0.96) |
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | December 31, 2022 2021 Warrants 344,990 491,586 Stock options 1,397,763 452,999 1,742,753 944,585 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue. | |
Schedule of recognized revenue under license and collaboration agreements | Year ended December 31, 2022 2021 Symbio Upfront license fee recognition over time $ 226,000 $ 226,000 |
Schedule of deferred revenue | Symbio Upfront Payment Deferred balance at December 31, 2021 $ 3,469,000 Recognition to revenue (226,000) Deferred balance at December 31, 2022 $ 3,243,000 |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Detail | |
Schedule of prepaid expenses and other current assets | December 31, 2022 2021 Research and development $ 233,000 $ 15,000 Manufacturing 97,000 29,000 Insurance 191,000 253,000 Other 40,000 35,000 $ 561,000 $ 332,000 |
Schedule of accrued expenses and other current liabilities | December 31, 2022 2021 Research and development $ 2,593,000 $ 1,759,000 Employee compensation 1,187,000 1,217,000 Professional fees 180,000 156,000 $ 3,960,000 $ 3,132,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of income taxes based on income (loss) before income tax expense | December 31, 2022 2021 Domestic $ (18,977,000) $ (16,153,000) Foreign 13,000 (10,000) $ (18,964,000) $ (16,163,000) |
Schedule of principal components of the Company's deferred tax assets | December 31, 2022 2021 Deferred tax assets: Net operating loss carryovers $ 73,394,000 $ 81,468,000 R&D tax credits 90,522,000 88,721,000 Non-qualified stock options 2,135,000 2,194,000 Deferred revenue 809,000 1,002,000 Charitable contributions — 4,000 Accrued expenses 395,000 447,000 Capitalized research and development costs 2,867,000 — Stock Appreciation Rights 12,000 19,000 Deferred tax assets 170,134,000 173,855,000 Deferred tax liabilities: Fixed Assets — (1,000) Deferred tax liabilities — (1,000) Less valuation allowance (170,134,000) (173,854,000) Net deferred tax assets $ — $ — |
Schedule of reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements | December 31, 2022 2021 Federal income tax expense at statutory rate 21.0 % 21.0 % Permanent items — 0.4 State income tax, net of federal benefit 1.3 8.0 Tax credits 9.5 7.4 Change in valuation allowance 19.6 (34.1) Deferred tax adjustment (0.2) (2.6) State tax rate change (50.2) — Other (1.0) (0.1) Effective income tax rate — % — % |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Year Ended December 31, 2022 2021 General and administrative $ 538,000 $ 490,000 Research and development 617,000 86,000 $ 1,155,000 $ 576,000 |
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 $ — Granted 1,044,165 $ 1.37 9.48 — Exercised — $ — — $ — Forfeitures/adjustments (99,401) $ 8.77 8.77 Balance, December 31, 2022 1,397,763 $ 7.15 9.18 $ — Exercisable at December 31, 2022 232,488 $ 33.35 8.28 $ — |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Year ended December 31, 2022 2021 Risk-free interest rate 2.65 % 0.89 % Expected volatility 121.11 % 133.77 % Expected term 5.77 years 5.93 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 1.19 $ 4.60 |
Nature of Business (Details)
Nature of Business (Details) | 1 Months Ended | 12 Months Ended | 16 Months Ended | ||||||||
Sep. 28, 2021 shares | Aug. 20, 2021 USD ($) | May 20, 2021 $ / shares shares | Feb. 16, 2021 shares | Jan. 11, 2021 shares | Sep. 30, 2021 $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | May 19, 2021 shares | Dec. 31, 2020 USD ($) | |
Liquidity | |||||||||||
Number of clinical programs (in programs) | 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 | $ (18,964,000) | $ (16,163,000) | |||||||||
Accumulated deficit | 463,683,000 | 444,719,000 | $ 463,683,000 | ||||||||
Cash and cash equivalents | $ 38,757,000 | $ 55,070,000 | $ 38,757,000 | $ 19,025,000 | |||||||
Issuance of common stock, net (in shares) | shares | 5,000,000 | 1,916,667 | 1,303,408 | ||||||||
Piper Sandler & Co | |||||||||||
Liquidity | |||||||||||
Sale of Stock, Price Per Share | $ / shares | $ 5.32 | ||||||||||
Issuance of common stock, net (in shares) | shares | 109,523 | 0 | 0 | 109,523 | |||||||
Piper Sandler & Co | Maximum | At the Market Equity | |||||||||||
Liquidity | |||||||||||
Market equity agreement maximum proceeds | $ 25,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) segment | |
Summary of Significant Accounting Policies | |
Reverse stock split | one-for-fifteen |
Number of operating segments | segment | 1 |
Interest income | $ | $ 651,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Concentrations of Credit Risk and Off-Balance Sheet Risk (Details) | Dec. 31, 2022 USD ($) |
Risks and Uncertainties [Abstract] | |
Off-balance sheet risk, asset | $ 0 |
Off-balance sheet risk, liability | 0 |
Cash and cash equivalents | $ 38,522,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Property and Equipment | |
Impairment losses | $ 0 |
Laboratory equipment | Minimum | |
Property and Equipment | |
Estimated useful lives | 5 |
Laboratory equipment | Maximum | |
Property and Equipment | |
Estimated useful lives | P6Y |
Software | |
Property and Equipment | |
Estimated useful lives | P3Y |
Computer and office equipment | Minimum | |
Property and Equipment | |
Estimated useful lives | 5 |
Computer and office equipment | Maximum | |
Property and Equipment | |
Estimated useful lives | P6Y |
Property and Equipment - Proper
Property and Equipment - Property and Equipment and Related Accumulated Depreciation (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Property and Equipment | ||
Less accumulated depreciation | $ (46,000) | $ (32,000) |
Property and equipment, net | 24,000 | 38,000 |
Computer and office equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 70,000 | $ 70,000 |
Property and Equipment - Deprec
Property and Equipment - Depreciation and Amortization Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property and Equipment | ||
Depreciation and amortization expense | $ 14,000 | $ 14,000 |
Warrants (Details)
Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants outstanding and warrant activity | ||
Warrants outstanding | 353,512 | 500,108 |
Warrants Expired (in shares) | (146,596) | |
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 | |
Warrants Expired (in shares) | (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 | |
Warrants Expired (in shares) | (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 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock - Computation of Basic and Diluted Earnings per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Basic and diluted net loss per share of common stock: | ||
Net loss attributable to Onconova Therapeutics, Inc. | $ (18,964,000) | $ (16,163,000) |
Basic weighted average shares outstanding (in shares) | 20,908,235 | 16,832,198 |
Diluted weighted average shares outstanding (in shares) | 20,908,235 | 16,832,198 |
Net loss per share of common stock, basic | $ (0.91) | $ (0.96) |
Net loss per share of common stock, diluted | $ (0.91) | $ (0.96) |
Net Loss Per Share of Common _4
Net Loss Per Share of Common Stock (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 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 | 1,742,753 | 944,585 |
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 | 344,990 | 491,586 |
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 | 1,397,763 | 452,999 |
Revenue (Details)
Revenue (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | ||
Revenue | $ 226,000 | $ 226,000 |
Activity in deferred revenue | ||
Balance at the beginning of the period | 226,000 | |
Balance at the end of the period | 226,000 | 226,000 |
SymBio | ||
Activity in deferred revenue | ||
Balance at the beginning of the period | 3,469,000 | |
Deferred revenue recognized | (226,000) | |
Balance at the end of the period | 3,243,000 | 3,469,000 |
License and collaboration agreements. | SymBio | ||
Revenue | ||
Revenue | $ 226,000 | $ 226,000 |
Balance Sheet Detail - Prepaid
Balance Sheet Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid expenses and other current assets: | ||
Research and development | $ 233,000 | $ 15,000 |
Manufacturing | 97,000 | 29,000 |
Insurance | 191,000 | 253,000 |
Other | 40,000 | 35,000 |
Prepaid expenses and other current assets | $ 561,000 | $ 332,000 |
Balance Sheet Detail - Accrued
Balance Sheet Detail - Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Detail | ||
Research and development | $ 2,593,000 | $ 1,759,000 |
Employee compensation | 1,187,000 | 1,217,000 |
Professional fees | 180,000 | 156,000 |
Accrued expenses and other current liabilities | $ 3,960,000 | $ 3,132,000 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy Table (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2022 | |
Liabilities measured at fair value | ||
Change in fair value of warrant liability | $ 321,000 | |
Recurring basis | ||
Liabilities measured at fair value | ||
Financial liabilities | $ 0 | $ 0 |
Income Taxes - Income (Loss) be
Income Taxes - Income (Loss) before Income Tax Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income taxes based on income (loss) before income tax expense | ||
Domestic | $ (18,977,000) | $ (16,153,000) |
Foreign | 13,000 | (10,000) |
Net loss before income taxes | $ (18,964,000) | $ (16,163,000) |
Income Taxes - Net Operating Lo
Income Taxes - Net Operating Loss Carryforwards (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | |
Income Taxes | |||||
Net operating loss with indefinite life | $ 89,700,000 | $ 89,700,000 | $ 89,700,000 | $ 89,700,000 | |
Federal | |||||
Income Taxes | |||||
Net operating loss (NOL) carry forwards | $ 298,100,000 | ||||
Net operating loss with expiration from 2022 to 2044 | $ 208,400,000 | ||||
NOL indefinite life percentage of limitation | 80% | ||||
State | |||||
Income Taxes | |||||
Net operating loss (NOL) carry forwards | $ 257,800,000 |
Income Taxes - Tax Credit Carry
Income Taxes - Tax Credit Carry Forwards (Details) - USD ($) | Jan. 01, 2022 | Dec. 31, 2022 |
Foreign | ||
Income Taxes | ||
Research and development expenses | 15 years | |
State | ||
Income Taxes | ||
Research and development expenses | 5 years | |
Research and Development Tax Credit Carry Forwards | Federal | ||
Income Taxes | ||
Tax credit carry forwards | $ 89,700,000 | |
Research and Development Tax Credit Carry Forwards | State | ||
Income Taxes | ||
Tax credit carry forwards | $ 1,100,000 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) | Dec. 31, 2022 USD ($) |
Unrecognized tax benefits | |
Unrecognized income tax benefits | $ 0 |
Interest and penalties accrued | $ 0 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryovers | $ 73,394,000 | $ 81,468,000 |
R&D tax credits | 90,522,000 | 88,721,000 |
Non-qualified stock options | 2,135,000 | 2,194,000 |
Deferred revenue | 809,000 | 1,002,000 |
Charitable contributions | 4,000 | |
Accrued expenses | 395,000 | 447,000 |
Capitalized research and development costs | 2,867,000 | |
Stock Appreciation Rights | 12,000 | 19,000 |
Deferred tax assets | 170,134,000 | 173,855,000 |
Deferred tax liabilities: | ||
Fixed Assets | (1,000) | |
Deferred tax liabilities | (1,000) | |
Less valuation allowance | (170,134,000) | (173,854,000) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Valuation Allowa
Income Taxes - Valuation Allowance (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Net change in valuation allowance | $ 3,720,000 | $ 5,510,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax (Expense) Benefit at the Statutory Federal Income Tax Rate and Income Taxes (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes | ||
Federal income tax expense at statutory rate (as a percent) | 21% | 21% |
Permanent items (as a percent) | 0.40% | |
State income tax, net of federal benefit (as a percent) | 1.30% | 8% |
Tax credits (as a percent) | 9.50% | 7.40% |
Change in valuation allowance (as a percent) | 19.60% | (34.10%) |
Deferred tax adjustment | (0.20%) | (2.60%) |
State tax rate change | (50.20%) | |
Other (as a percent) | (1.00%) | (0.10%) |
Effective income tax rate (as a percent) | 0% | 0% |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | 12 Months Ended | ||
Jun. 17, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | |
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) | 2,000,000 | ||
2021 Incentive Plan | Common Stock | |||
Stock-Based Compensation | |||
Reserved for issuance (in shares) | 1,711,127 | ||
Restricted Stock Units (RSUs) | |||
Stock-Based Compensation | |||
Cancelled (in shares) | 0 | 0 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-Based Compensation | ||
Net tax benefits related to the stock-based compensation costs | $ 0 | |
Compensation expense | 1,155,000 | $ 576,000 |
General and administrative | ||
Stock-Based Compensation | ||
Compensation expense | 538,000 | 490,000 |
Research and development | ||
Stock-Based Compensation | ||
Compensation expense | $ 617,000 | $ 86,000 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Activity (Details) - Stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Shares Available for Grant | ||
Granted (in shares) | (1,044,165) | |
Forfeitures/adjustments (in shares) | (99,401) | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 452,999 | |
Granted (in shares) | 1,044,165 | |
Forfeitures/adjustments (in shares) | (99,401) | |
Balance at the end of the period (in shares) | 1,397,763 | 452,999 |
Exercisable at the end of the period (in shares) | 232,488 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 20.71 | |
Granted (in dollars per share) | 1.37 | |
Forfeitures (in dollars per share) | 8.77 | |
Balance at the end of the period (in dollars per share) | 7.15 | $ 20.71 |
Exercisable at the end of the period (in dollars per share) | $ 33.35 | |
Additional Disclosures | ||
Weighted average remaining contractual term | 9 years 2 months 4 days | 9 years 5 months 1 day |
Weighted average remaining contractual term of options granted | 9 years 5 months 23 days | |
Weighted average remaining contractual term of options forfeitures | 8 years 9 months 7 days | |
Weighted average remaining contractual term of options exercisable | 8 years 3 months 10 days |
Stock-Based Compensation - Op_2
Stock-Based Compensation - Options Unrecognized Compensation Expense (Details) - Stock options | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 1,586,000 |
Weighted-average period for recognizing unrecognized compensation expense (in years) | 1 year 6 months 7 days |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Assumptions used | ||
Risk-free interest rate (as a percent) | 2.65% | 0.89% |
Expected volatility (as a percent) | 121.11% | 133.77% |
Expected term (in years) | 5 years 9 months 7 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) | $ 1.19 | $ 4.60 |
Stock-Based Compensation - RSUs
Stock-Based Compensation - RSUs, PSUs and SARs (Details) - USD ($) | 12 Months Ended | ||||
Jun. 10, 2022 | Feb. 07, 2022 | Aug. 02, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock outstanding (in shares) | 20,925,992 | 20,895,563 | |||
Compensation expense | $ 1,155,000 | $ 576,000 | |||
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 | $ 443,000 | ||||
Weighted-average period for recognizing unrecognized compensation expense (in years) | 1 year 11 months 26 days | ||||
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% |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - Retirement Savings Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Minimum age of employees required to be eligible for participation | 21 years | |
Minimum working hours per year required to be eligible for participation | 1000 hours | |
Employer's match for every dollar of the first specified percentage of payroll that employees invest | $ 0.75 | |
Employer's matching contribution percentage | 6% | |
Contributions | $ 131,000 | $ 114,000 |
Research Agreements (Details)
Research Agreements (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
License | |
Research Agreements | |
Revenue | $ 0 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Sep. 28, 2021 | Feb. 16, 2021 | Jan. 11, 2021 | Dec. 18, 2019 | Apr. 11, 2018 | Mar. 02, 2018 | Nov. 30, 2019 | Jan. 31, 2018 | Jul. 31, 2011 | Dec. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2021 | |
License and collaboration agreements | |||||||||||||
Issuance of common stock, net (in shares) | 5,000,000 | 1,916,667 | 1,303,408 | ||||||||||
Value of common stock | $ 55,041,000 | ||||||||||||
Issuance of common stock, net (in shares) | 5,000,000 | 1,916,667 | 1,303,408 | ||||||||||
Common Stock | |||||||||||||
License and collaboration agreements | |||||||||||||
Issuance of common stock, net (in shares) | 8,329,598 | ||||||||||||
Value of common stock | $ 83,000 | ||||||||||||
Issuance of common stock, net (in shares) | 8,329,598 | ||||||||||||
SymBio | Rigosertib | |||||||||||||
License and collaboration agreements | |||||||||||||
Percentage of royalty payments based on net sales of rigosertib (as a percent) | 20% | ||||||||||||
Revenue | $ 7,500,000 | ||||||||||||
Pint | Common Stock | |||||||||||||
License and collaboration agreements | |||||||||||||
Issuance of common stock, net (in shares) | 3,631 | ||||||||||||
Value of common stock | $ 1,250,000 | ||||||||||||
Issuance of common stock, net (in shares) | 3,631 | ||||||||||||
Redemption premium | $ 319,000 | ||||||||||||
License and collaboration agreements. | ON123300 | |||||||||||||
License and collaboration agreements | |||||||||||||
Revenue | $ 450,000 | ||||||||||||
License and collaboration agreements. | SymBio | |||||||||||||
License and collaboration agreements | |||||||||||||
Percentage of discount on future purchases | 35% | ||||||||||||
License and collaboration agreements. | SymBio | Maximum | |||||||||||||
License and collaboration agreements | |||||||||||||
Cumulative amount of discount on purchases | $ 300,000 | ||||||||||||
License and collaboration agreements. | SymBio | Rigosertib | |||||||||||||
License and collaboration agreements | |||||||||||||
Revenue | $ 7,500,000 | ||||||||||||
License and collaboration agreements. | HanX | ON123300 | |||||||||||||
License and collaboration agreements | |||||||||||||
Revenue | $ 450,000 | ||||||||||||
License and collaboration agreements. | Pint | |||||||||||||
License and collaboration agreements | |||||||||||||
Revenue | $ 319,000 | ||||||||||||
License and collaboration agreements. | Knight | |||||||||||||
License and collaboration agreements | |||||||||||||
Term of License Agreement | 15 years | ||||||||||||
Revenue | $ 100,000 | $ 100,000 | |||||||||||
License and collaboration agreements. | STA | |||||||||||||
License and collaboration agreements | |||||||||||||
Term of License Agreement | 15 years | ||||||||||||
Revenue | $ 50,000 | $ 50,000 |
Securities Registrations and _2
Securities Registrations and Sales Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 16 Months Ended | ||||||||
Sep. 28, 2021 | Sep. 23, 2021 | Aug. 20, 2021 | Feb. 16, 2021 | Feb. 10, 2021 | Jan. 11, 2021 | Jan. 07, 2021 | Sep. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Issuance of common stock, net (in shares) | 5,000,000 | 1,916,667 | 1,303,408 | ||||||||
Proceeds from issuance of common stock | $ 19,500,000 | $ 26,700,000 | $ 8,500,000 | $ 55,041,000 | |||||||
Lincoln Park Capital Fund, LLC | The Offering | |||||||||||
Expense reimbursement | $ 100,000 | ||||||||||
Percentage rights to participate | 50% | ||||||||||
Threshold period for exercise or conversion of stock | P1Y | ||||||||||
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 | $ 8,500,000 | ||||||||||
Guggenheim Securities, LLC | The Offering | |||||||||||
Issuance of common stock, net (in shares) | 5,000,000 | ||||||||||
Underwriters option exercisable term | 30 days | ||||||||||
Issue price (in dollars per share) | $ 4.20 | ||||||||||
Proceeds from issuance of common stock | $ 19,500,000 | ||||||||||
Cash fee | 6% | ||||||||||
Legal fees and expenses | $ 100,000 | ||||||||||
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 | P30D | ||||||||||
Proceeds from issuance of common stock | $ 26,700,000 | ||||||||||
Additional shares agreed to issue | 250,000 | ||||||||||
Cash fee | 6% | ||||||||||
Legal fees and expenses | $ 100,000 | ||||||||||
Piper Sandler & Co | |||||||||||
Issuance of common stock, net (in shares) | 109,523 | 0 | 0 | 109,523 | |||||||
Proceeds from issuance of common stock | $ 25,000,000 | $ 500,000 | $ 500,000 | ||||||||
Percentage of gross proceeds of shares of common stock sold | 3% | ||||||||||
Offer price (per share) | $ 5.32 | ||||||||||
Weighted average price per share | $ 5.32 | $ 5.32 | |||||||||
Maximum | Guggenheim Securities, LLC | Over-allotment | |||||||||||
Issuance of common stock, net (in shares) | 750,000 |