Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 27, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Transition Report | false | ||
Entity File Number | 001-34079 | ||
Entity Registrant Name | Ocuphire Pharma, Inc. | ||
Entity Central Index Key | 0001228627 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 11-3516358 | ||
Entity Address, Address Line One | 37000 Grand River Avenue, Suite 120 | ||
Entity Address, City or Town | Farmington Hills | ||
Entity Address, State or Province | MI | ||
Entity Address, Postal Zip Code | 48335 | ||
City Area Code | 248 | ||
Local Phone Number | 681-9815 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | OCUP | ||
Security Exchange Name | NASDAQ | ||
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 | $ 37,236,094 | ||
Entity Common Stock, Shares Outstanding | 20,947,830 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Detroit, Michigan | ||
Auditor Firm ID | 42 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 42,634 | $ 24,534 |
Accounts receivable (Note 10) | 1,298 | 0 |
Contract asset (Note 10) | 3,552 | 0 |
Prepaids and other current assets | 1,453 | 1,314 |
Short-term investments | 49 | 219 |
Total current assets | 48,986 | 26,067 |
Property and equipment, net | 6 | 10 |
Total assets | 48,992 | 26,077 |
Current liabilities: | ||
Accounts payable | 1,069 | 1,584 |
Accrued expenses | 1,684 | 1,733 |
Short-term loan | 0 | 538 |
Total current liabilities | 2,753 | 3,855 |
Warrant liabilities | 0 | 0 |
Total liabilities | 2,753 | 3,855 |
Commitments and contingencies (Note 4 and Note 8) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of December 31, 2022 and 2021; no shares issued and outstanding at December 31, 2022 and 2021. | 0 | 0 |
Common stock, par value $0.0001; 75,000,000 shares authorized as of December 31, 2022 and 2021; 20,861,315 and 18,845,828 shares issued and outstanding at December 31, 2022 and 2021, respectively. | 2 | 2 |
Additional paid-in-capital | 117,717 | 111,588 |
Accumulated deficit | (71,480) | (89,368) |
Total stockholders' equity | 46,239 | 22,222 |
Total liabilities and stockholders' equity | $ 48,992 | $ 26,077 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Stockholders' equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 20,861,315 | 18,845,828 |
Common stock, shares, outstanding (in shares) | 20,861,315 | 18,845,828 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Statements of Comprehensive Income (Loss) [Abstract] | ||
License and collaborations revenue | $ 39,850 | $ 589 |
Operating expenses: | ||
General and administrative | 7,269 | 8,121 |
Research and development | 14,355 | 15,173 |
Total operating expenses | 21,624 | 23,294 |
Income (loss) from operations | 18,226 | (22,705) |
Interest expense | (9) | (2) |
Fair value change in warrant liabilities | 0 | (33,829) |
Other expense, net | (14) | (157) |
Income (loss) before income taxes | 18,203 | (56,693) |
Provision for income taxes | (315) | 0 |
Net income (loss) | 17,888 | (56,693) |
Other comprehensive income (loss), net of tax | 0 | 0 |
Comprehensive income (loss) | $ 17,888 | $ (56,693) |
Net income (loss) per share (Note 11): | ||
Basic (in dollars per share) | $ 0.9 | $ (3.82) |
Diluted (in dollars per share) | $ 0.87 | $ (3.82) |
Number of shares used in per share calculations: | ||
Basic (in shares) | 19,931,080 | 14,852,745 |
Diluted (in shares) | 20,597,212 | 14,852,745 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2020 | $ 1 | $ 19,207 | $ (32,675) | $ (13,467) |
Balance (in shares) at Dec. 31, 2020 | 10,882,495 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Reclassification of Series A warrant liability to equity | $ 0 | 61,793 | 0 | 61,793 |
Issuance of common stock and warrants in connection with registered direct offering | $ 1 | 14,999 | 0 | 15,000 |
Issuance of common stock and warrants in connection with registered direct offering (in shares) | 3,076,923 | |||
Issuance of common stock in connection with the at-the-market program | $ 0 | 13,491 | 0 | 13,491 |
Issuance of common stock in connection with the at-the-market program (in shares) | 2,778,890 | |||
Issuance of common stock in connection with settlement with investors | $ 0 | 1,614 | 0 | 1,614 |
Issuance of common stock in connection with settlement with investors (in shares) | 350,000 | |||
Issuance costs | $ 0 | (1,517) | 0 | (1,517) |
Exercise of Series B warrants | $ 0 | 0 | 0 | 0 |
Exercise of Series B warrants (in shares) | 1,629,634 | |||
Stock-based compensation | $ 0 | 1,914 | 0 | 1,914 |
Stock-based compensation (in shares) | 54,444 | |||
Exercise of stock options | $ 0 | 87 | 0 | 87 |
Exercise of stock options (in shares) | 73,442 | |||
Net and comprehensive income (loss) | $ 0 | 0 | (56,693) | (56,693) |
Balance at Dec. 31, 2021 | $ 2 | 111,588 | (89,368) | 22,222 |
Balance (in shares) at Dec. 31, 2021 | 18,845,828 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with the at-the-market program | $ 0 | 4,428 | 0 | 4,428 |
Issuance of common stock in connection with the at-the-market program (in shares) | 1,848,980 | |||
Issuance costs | $ 0 | (133) | 0 | (133) |
Exercise of Series B warrants | $ 0 | 0 | 0 | 0 |
Exercise of Series B warrants (in shares) | 60,832 | |||
Stock-based compensation | $ 0 | 1,807 | 0 | 1,807 |
Stock-based compensation (in shares) | 81,366 | |||
Exercise of stock options | $ 0 | 27 | 0 | 27 |
Exercise of stock options (in shares) | 24,309 | |||
Net and comprehensive income (loss) | $ 0 | 0 | 17,888 | 17,888 |
Balance at Dec. 31, 2022 | $ 2 | $ 117,717 | $ (71,480) | $ 46,239 |
Balance (in shares) at Dec. 31, 2022 | 20,861,315 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net income (loss) | $ 17,888 | $ (56,693) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Stock-based compensation | 1,807 | 1,914 |
Depreciation | 4 | 4 |
Fair value change in warrant liabilities | 0 | 33,829 |
Non-cash share settlement with investors | 0 | 1,614 |
Receipt of investments related to license agreement | 0 | (289) |
Unrealized loss from short-term investments | 170 | 70 |
Change in assets and liabilities: | ||
Accounts receivable | (1,298) | 0 |
Contract asset | (3,552) | 0 |
Prepaid expenses and other assets | (139) | (45) |
Accounts payable | (515) | 381 |
Accrued expenses | (51) | (155) |
Net cash provided by (used in) operating activities | 14,314 | (19,370) |
Investing activities | ||
Transaction costs in connection with asset acquisition | 0 | (100) |
Net cash used in investing activities | 0 | (100) |
Financing activities | ||
Proceeds from issuance of common stock | 4,428 | 28,491 |
Issuance costs attributed to common stock | (131) | (1,511) |
Proceeds from short-term loan | 0 | 646 |
Payments made on short-term loan principal | (538) | (108) |
Exercise of stock options and Series B warrants | 27 | 87 |
Net cash provided by financing activities | 3,786 | 27,605 |
Net increase in cash and cash equivalents | 18,100 | 8,135 |
Cash and cash equivalents at beginning of period | 24,534 | 16,399 |
Cash and cash equivalents at end of period | 42,634 | 24,534 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 0 | 0 |
Cash paid for interest | 9 | 2 |
Supplemental non-cash financing transactions: | ||
Non-cash reclassification of Series A warrant liability to equity | 0 | 61,793 |
Unpaid issuance costs | $ 2 | $ 6 |
Company Description and Summary
Company Description and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | |
Company Description and Summary of Significant Accounting Policies | 1. Company Description and Summary of Significant Accounting Policies Nature of Business Ocuphire Pharma, Inc. (the “Company” or “Ocuphire”) is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. Ocuphire’s pipeline currently includes two small molecule product candidates targeting several of such indications. In November 2022, the Company entered into a license and collaboration agreement (the “Nyxol License Agreement”) with FamyGen Life Sciences, Inc. (acquired by Viatris, Inc. (“Viatris”) in January 2023) pursuant to which it granted Viatris an exclusive license to develop, manufacture, import, export and commercialize its product candidate phentolamine ophthalmic solution 0.75% (Nyxol® Eye Drops or “Nyxol”). Nyxol is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. Nyxol can potentially be used across multiple indications such as treatment of pharmacologically-induced mydriasis (“RM”) (dilation of the pupil), presbyopia (age-related blurry near vision) and dim light or night vision disturbances (“DLD”) (halos, glares and starbursts). The Company’s second product candidate, APX3330, is a twice-a-day oral tablet designed to target multiple pathways relevant to retinal and choroidal (the vascular layer of the eye) diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual blindness. The Company has also in-licensed APX2009 and APX2014, which are second-generation product candidates and analogs of APX3330. License and collaborations revenue to date was derived from a one-time non-refundable payment and reimbursement of expenses earned under the Nyxol License Agreement, and to a much lesser degree, from license agreements with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc. (“Processa”) in connection with the Rexahn RX-3117 drug compound. The Company anticipates that it will recognize revenue as it earns reimbursement for research and development services in connection with the Nyxol License Agreement and it may earn additional revenues from future potential milestone and royalty payments from the agreements with Viatris, BioSense, Processa, or from other license agreements entered into the future; however, the attainment of milestones or level of sales required to earn royalty payments is highly uncertain. Outside of the license and collaborations revenue, the Company does not expect to generate significant revenue unless or until regulatory approval is obtained and commercialization begins for Nyxol or APX3330. Management plans to continue financing the Company’s operations primarily through additional issuances of the Company’s equity and debt securities or through collaborations or partnerships with other companies. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate part or all of its research and development programs. Reverse Merger with Rexahn On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”), Razor Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rexahn (“Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization, as amended on June 29, 2020 (as amended, the “Merger Agreement”), pursuant to which, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub would merge with and into Ocuphire, with Ocuphire continuing as a wholly-owned subsidiary of Rexahn and the surviving corporation of the merger (the “Merger”). The Merger closed on November 5, 2020. Upon completion of the Merger, Rexahn changed its name to Ocuphire Pharma, Inc. and changed its ticker symbol on the Nasdaq Capital Market to “OCUP”. The Company’s headquarters is located in Farmington Hills, Michigan. Global Economic Conditions Generally, worldwide economic conditions remain uncertain, particularly due to the effects of th e COVID‑ 19 pande The COVID-19 pandemic that began in late 2019 introduced significant volatility to the global economy, disrupted supply chains and had a widespread adverse effect on the financial markets. As a result of the COVID-19 pandemic, the Company has experienced, and may continue to experience, delays and disruptions in our clinical trials, as well as interruptions in our manufacturing, supply chain, shipping and research and development operations. Testing and clinical trials, manufacturing, component supply, shipping and research and development operations may be further impacted by the continuing effects of COVID-19. Additionally, the Company’s operating results could be materially impacted by changes in the overall macroeconomic environment and other economic factors. Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the conflict in Ukraine, and steps taken by governments and central banks, particularly in response to the COVID- pandemic as well as other stimulus and spending programs, have led to higher inflation, which has led to an increase in costs and has caused changes in fiscal and monetary policy, including increased interest rates. Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting standards generally accepted in the United States of America (“GAAP”). On December 31, 2021, the Company merged its wholly owned subsidiary, OcuSub Inc, with and into the Company, with the Company remaining as the surviving entity. The merger of the Company’s wholly owned subsidiary did not have a financial impact to the periods presented. Upon close of this merger, the Company did not have any remaining entities that required consolidation for financial statement reporting purposes. Liquidity The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern. From its inception, the Company has devoted substantially all of its efforts to drug discovery and development and conducting clinical trials. The Company entered into the Nyxol License Agreement, and the one-time In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the ultimate outcome of these actions to generate the liquidity ultimately required. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development and commercialization of products related to vision performance and health. Accordingly, the Company has a single reporting segment. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of deposit to be cash equivalents. Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. As of December 31, 2022, the Company’s cash was held by two large financial institutions in the United States. Amounts on deposit may at times exceed federally insured limits. As of December 31, 2022, the Company had deposits that exceeded federally insured amounts by approximately $42.1 million. Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and are recorded on a settlement date basis. The Company’s investments are comprised of equity securities, which in accordance with the fair value hierarchy described below are recorded at fair value using Level l inputs on the balance sheets. Subsequent changes in fair values are recorded in other expense, net on the consolidated statements of comprehensive income (loss). The Company classifies investments available to fund current operations as current assets on its balance sheets. The Company did not recognize any impairments on its investments to date through December 31, 2022. Revenue Recognition The Company follows the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers . The guidance provides a five-step model to determine how revenue is recognized. The Company has entered into license agreements which have revenue recognition implications (See Note 10 – License and Collaboration Agreements). In determining the appropriate amount of revenue to be recognized, the Company performs the following steps: (i) identification of the contracts with a customer; (ii) determination of the performance obligations in the contract; (iii) measurement of the transaction price, including potential constraints on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated stand-alone selling prices; and (v) recognition of revenue when (or as) the Company satisfies a performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606. Performance obligations may include license rights, development and other services. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation based on the relative standalone selling prices of the promised goods or service underlying each performance obligation. Licenses of intellectual property and research and development services: Milestone payments: Royalties: Contract Asset The Company recognizes a contract asset when goods or services are transferred to the customer before the customer pays or before payment is due, excluding any amounts presented as an accounts receivable. The Company recorded a contract asset in connection with a license and collaboration agreement in the amount of $3.6 million as of December 31, 2022. See Note 10 - License and Collaboration Agreements. Accounts Receivable and Allowances for Doubtful Accounts The Company records a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable. In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable, its historical write-offs, the credit worthiness of each customer, and general economic conditions. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance. The Company has not incurred any bad debt expense during the years ended December 31, 2022 or 2021 and no allowance for doubtful accounts has been recorded during the periods presented. General and Administrative Expenses General and administrative expenses (“G&A”) consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, settlement costs with third parties and other services provided by business consultants. Research and Development Research and development expenses (“R&D”) consist of costs incurred in performing research and development activities, including compensation for research and development employees and consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, fees paid to external service providers that conduct certain research and development, and an allocation of R&D related overhead expenses. R&D costs include costs that are reimbursed under the Nyxol License Agreement. Other Expense, net Other expense, net reflected in this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former Rexahn shareholders. In addition, other expense, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in connection with grants and other sources when they occur. Stock-based Compensation The Company accounts for stock-based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) ASC 718, Compensation — Stock Compensation Warrant Liabilities The Company issued Series A Warrants in connection with the Pre-Merger Financing (see Note 3 – Pre-Merger Financing) and assumed Rexahn warrants issued prior to the Merger. The Company accounts for these warrants as a liability while outstanding at fair value during periods when certain provisions preclude equity accounting treatment for these instruments. Additionally, issuance costs associated with the warrants classified as liabilities were expensed as incurred and reflected as interest expense in the accompanying consolidated statements of comprehensive income (loss). The change in fair value of the warrant liabilities while outstanding were recognized as a component of the fair value change in warrant liabilities line item in the consolidated statements of comprehensive income (loss). Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy: • Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets; • Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and • Level 3 inputs: Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. As of December and the fair values of cash and cash equivalents, accounts receivable, contract asset, prepaid and other assets, accounts payable, accrued expenses and short-term loan, while outstanding, approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the short-term investments was based on observable Level inputs in the form of quoted market prices from a major stock exchange. The fair value of the warrant liabilities, while outstanding, was based on cash flow models discounted at current implied market rates evidenced in recent arms-length transactions representing expected returns by market participants for similar instruments and were based on Level inputs. There were no transfers between fair value hierarchy levels during the years ended December 31, 2022 and 2021. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 49 $ 49 $ — $ — Total assets at fair value $ 49 $ 49 $ — $ — As of December 31, 2021 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 219 $ 219 $ — $ — Total assets at fair value $ 219 $ 219 $ — $ — The following table provides a roll-forward of investments measured at fair value on a recurring basis using observable level 1 inputs for the year ended December 31, 2022 and 2021 (in thousands): 2022 2021 Short-term investments Balance as of beginning of period $ 219 $ — Receipt of investments related to license agreement — 289 Unrealized loss (170 ) (70 ) Balance as of end of period $ 49 $ 219 The following table provides a roll-forward of the warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the year ended December 31, 2021 (in thousands): 2021 Warrant liabilities Balance as of beginning of period $ 27,964 Change in fair value of warrant liabilities 33,829 Reclassification of warrants from liability to equity (61,793 ) Balance as of end of period $ — The fair value of the warrant liabilities associated with the Rexahn warrants was de minimis during the years ended December 31, 2022 and 2021. See Note 2 - Merger. There were no financial instruments measured on a non-recurring basis for any of the periods presented. Income Taxes The Company utilizes the liability method of accounting for income taxes as required by ASC 740, Income Taxes Property and Equipment, net Property and equipment, net is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. Equipment and furniture are depreciated over a five-year estimated useful life. Tangible assets acquired for research and development activities which have alternative use are capitalized and depreciated over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, “ Financial Instruments – Credit Losses” In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this ASU are effective for public business entities that meet the definition of a Securities and Exchange Commission (“SEC”) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company does not expect that the adoption of this ASU on January 1, 2023 on its consolidated financial statements will be material . In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency of government assistance including the disclosure of the types of assistance, an entity’s accounting for the assistance, and the effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted this guidance on January 1, 2022 and it did not have a material impact to the consolidated financial statements. |
Merger
Merger | 12 Months Ended |
Dec. 31, 2022 | |
Merger [Abstract] | |
Merger | 2. Merger On November 5, 2020, the Company completed the Merger transaction with Rexahn. In connection with the Merger, the Company, Shareholder Representatives Services LLC, as representative of the Rexahn stockholders prior to the Merger, and Olde Monmouth Stock Transfer Co., Inc., as the rights agent, entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Pursuant to the terms of the Merger and the CVR Agreement, Rexahn stockholders of record as of immediately prior to the effective time of the Merger received one contingent value right (“CVR”) for each share of Rexahn common stock held. Each CVR entitles such holders to receive, for each calendar quarter (each, a “CVR Payment Period”) during the 15-year period after the Closing (the “CVR Term”), an amount equal to the following: • 90% of all payments received by Rexahn or its affiliates during such CVR Payment Period from or on behalf of BioSense Global LLC (“BioSense”) pursuant to that certain License and Assignment Agreement, dated as of February 25, 2019, by and between BioSense and Rexahn, as amended by Amendment No. 1, dated August 24, 2019, and as further amended by Amendment No. 2, dated March 10, 2020, minus certain permitted deductions; • 90% of all payments received by Rexahn or its affiliates during such CVR Payment Period from or on behalf of Zhejiang HaiChang Biotechnology Co., Ltd. (“HaiChang”) pursuant to that certain Exclusive License Agreement, dated as of February 8, 2020, by and between HaiChang and Rexahn, minus certain permitted deductions; and • 75% of the sum of (i) all cash consideration paid by a third party to Rexahn or its affiliates during the applicable CVR Payment Period in connection with the grant, sale or transfer of rights to Rexahn’s pre-closing intellectual property (other than a grant, sale or transfer of rights involving a sale or disposition of the post-Merger combined company) that is entered into during the 10-year period after the Closing (“Parent IP Deal”), plus (ii) with respect to any non-cash consideration received by Rexahn or its affiliates from a third party during the applicable CVR Payment Period in connection with any Parent IP Deal, all amounts received by Rexahn and its affiliates for such non-cash consideration at the time such non-cash consideration is monetized by Rexahn or its affiliates, minus (iii) certain permitted deductions. The CVRs are not transferable, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the SEC or listed for trading on any exchange. The CVR Agreement will continue in effect until the later of the end of the CVR Term and the payment of all amounts payable thereunder. Former Rexahn Warrants Following the closing of the Merger, 231,433 outstanding, unexercised Rexahn warrants to purchase common stock remained outstanding, the majority of which were subsequently repurchased according to the terms of the original warrant agreements. As of December 31 2022, 60,713 of the Rexahn warrants remained outstanding with exercise prices ranging from $38.40 to $136.80 per share with an average remaining contractual life of 1.0 years. |
Pre-Merger Financing
Pre-Merger Financing | 12 Months Ended |
Dec. 31, 2022 | |
Pre-Merger Financing [Abstract] | |
Pre-Merger Financing | 3. Pre-Merger Financing On June 17, 2020, Ocuphire, Rexahn and certain investors entered into a Securities Purchase Agreement, which was amended and restated in its entirety on June 29, 2020 (as amended and restated, the “Securities Purchase Agreement”). Pursuant to the Securities Purchase Agreement, the investors invested a total of $21.15 million in cash, including $300,000 invested by five directors of Ocuphire Pharma, Inc., prior to the Merger and one director of Rexahn upon closing of the Merger (the “Pre-Merger Financing”). The Pre-Merger Financing also included the issuance of Series A Warrants and Series B Warrants discussed further below. Waiver Agreements Effective February 3, 2021, each investor that invested in the Pre-Merger Financing entered into a Waiver Agreement with the Company (collectively, the “Waiver Agreements”). Pursuant to the Waiver Agreements, the investors and the Company agreed to waive certain rights, finalize the exercise price and number of Series A Warrants and Series B Warrants, eliminate certain financing restrictions, extend the term of certain leak-out agreements, and, in the case of certain investors, grant certain registration rights for the shares underlying the warrants. The Waiver Agreements provide for the elimination of the full ratchet anti-dilution provisions contained in the Series A Warrants (as certain of the anti-dilution provisions had previously caused liability accounting treatment for the Series A Warrants). Upon the effective date of the Waiver Agreements, the Series A Warrants were reclassified to equity. Pursuant to the Waiver Agreements, the number of shares underlying all of the Series B Warrants was fixed in the aggregate with respect to all investors, eliminating any future resets. Series A Warrants The Series A Warrants were issued on November 19, 2020 at an initial exercise price of $4.4795 per share, were immediately exercisable upon issuance and have a term of five years from the date of issuance. The Series A Warrants are exercisable for 5,665,838 shares of common stock in the aggregate (without giving effect to any limitation on exercise contained therein) and were outstanding as of December 31, 2022. Prior to the execution of the Waiver Agreements, the Series A Warrants were accounted for and classified as liabilities on the accompanying balance sheets given certain price reset provisions not used for a fair valuation under a fixed for fixed settlement scenario as required for equity balance sheet classification. Upon the February 3, 2021 effective date of the Waiver Agreements, the Series A Warrants were reclassified to equity. A final fair valuation of the Series A Warrants was performed utilizing a Black Scholes model to estimate the aggregate fair value of the Series A Warrants prior to being re-classified as equity. Input assumptions used were as follows: risk-free interest rate 0.4%; expected volatility of 86.6%; expected life of 4.8 years; and expected dividend yield zero percent. The underlying stock price used was the market price as quoted on Nasdaq as of February 3, 2021, the effective date of the Waiver Agreement. The fair value change of the Series A Warrants was $33.8 million and was recorded to the fair value change in warrant liabilities line item on the accompanying consolidated statements of comprehensive income (loss) for year ended December 31, 2021. As a result of the reclassification to equity, the Series A Warrants are no longer subject to remeasurement. Series B Warrants The Series B Warrants have an exercise price of $0.0001, were exercisable upon issuance and will expire on the day following the later to occur of (i) the Reservation Date (as defined therein), and (ii) the date on which the investor’s Series B Warrants have been exercised in full (without giving effect to any limitation on exercise contained therein) and no shares remain issuable thereunder. The Series B Warrants outstanding as of December 31, 2022 were exercisable for 17,869 shares of common stock. The Series B Warrants were accounted for and classified as equity on the accompanying balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 4. Commitments and Contingencies Apexian Sublicense Agreement On January 21, 2020, the Company entered into a sublicense agreement with Apexian Pharmaceuticals, Inc., pursuant to which it obtained exclusive worldwide patent and other intellectual property rights. In exchange for the patent and other intellectual rights, the Company agreed to certain milestone payments and royalty payments on future sales (See Note 8 — Apexian Sublicense Agreement). As of December 31, 2022, there was sufficient uncertainty with regard to any future cash milestone payments under the sublicense agreement, and as such, no liabilities were recorded related to the sublicense agreement. Facility Leases The Company has a short-term non-cancellable facility lease (the “HQ Lease”) for its operations and headquarters. Additionally, Ocuphire leased office space in Rockville, Maryland through June 30, 2021 previously occupied by Rexahn (the “Rexahn Lease”). The HQ Lease and the Rexahn Lease qualified for the short-term lease exception under ASC 842, Leases. The monthly base rent, as amended, for the HQ Lease is approximately $3,000. The monthly base rent for the Rexahn Lease was $13,000. The rent expense associated with the HQ Lease and Rexahn Lease amounted to $39,000 and $116,000 during the years ended December 31, 2022 and 2021, respectively. The total remaining expected rental payments under the HQ Lease amount to $36,000 through its current expiration date of December 31, 2023. Issuance of Settlement Shares On May 6, 2021, the Company issued 350,000 shares of common stock of the Company to three accredited investors pursuant to a settlement agreement, dated May 6, 2021, in exchange for a release of potential claims. The fair value of the share settlement of $1,614,000 was based on the closing Ocuphire stock price for that day. The fair value of the share settlement was recorded in general and administrative expenses in the accompanying consolidated statements of comprehensive income (loss). Other In the ordinary course of business, from time to time, the Company may be subject to a broad range of claims and legal proceedings that relate to contractual allegations, patent infringement and other claims. In addition, the Company from time to time may be potentially committed to reimburse third parties for costs incurred associated with business development related transactions upon the achievement of certain milestones. The Company establishes accruals when applicable for matters and commitments which it believes losses are probable and can be reasonably estimated. To date, no loss contingency for such matters and potential commitments have been recorded. Although it is not possible to predict with certainty the outcome of these matters or potential commitments, the Company is of the opinion that the ultimate resolution of these matters and potential commitments will not have a material adverse effect on its results of operations or financial position. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 12 Months Ended |
Dec. 31, 2022 | |
Supplemental Balance Sheet Information [Abstract] | |
Supplemental Balance Sheet Information | 5. Supplemental Balance Sheet Information Prepaid and Other Assets Prepaid and other assets consist of the following (in thousands): December 31, 2022 2021 Prepaids $ 1,373 $ 1,243 Other 80 71 Total prepaids and other assets $ 1,453 $ 1,314 Property and Equipment, net Property and equipment held for use by category are presented in the following table (in thousands): December 31, 2022 2021 Equipment $ 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (19 ) (15 ) Property and equipment, net $ 6 $ 10 Depreciation expense was $4,000 during each of the years ended December 31, 2022 and 2021. Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, 2022 2021 Income taxes $ 315 $ — Payroll 782 488 Professional services 208 84 R&D services and supplies 212 1,081 Other 167 80 Total $ 1,684 $ 1,733 Short-Term Loan The Company entered into an unsecured short-term loan (the “Loan”) agreement in the amount of $0.6 million in November 2021 related to financing an insurance policy. The Loan was payable in six monthly installments of $108,000 beginning in December 2021. The Loan had an annual interest rate of 5.5% per annum. Interest expense in the amount of $9,000 and $2,000 was recognized in connection with the Loan during the years ended December 31, 2022 and 2021, respectively. The final payment on the Loan was made in May 2022. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 6. Related Party Transactions Pre-Merger Financing and Waiver Agreements Five directors of Ocuphire Pharma, Inc., prior to the Merger, and one director of Rexahn participated in the Pre-Merger Financing, investing an aggregate of $300,000. Following the closing of the Merger, these directors received 17,729 converted initial shares of common stock, 53,189 converted shares of additional common stock, 80,366 Series A Warrants and 9,444 Series B Warrants. In connection with the Pre-Merger Financing, six directors of the Company signed Waiver Agreements, waiving certain reset provisions and financing restrictions. These directors did not receive any of the additional Series B Warrants that were issued in connection with the Waiver Agreements. See Note 3 – Pre-Merger Financing. Other On April 8, 2022, Ocuphire entered into a consulting agreement with a director of the Company. The consulting agreement provided for $10,000 a month in cash payments, effective as of April 1, 2022. Additionally, on April 8, 2022, in connection with the consulting arrangement, the director received a stock option grant for 50,000 options, 25% of which will vest on March 31, 2023, with the remainder vesting in equal monthly installments over 36 months. The consulting agreement was amended on September 19, 2022 to provide for vesting acceleration for stock-based awards in the event of a change in control. The consulting agreement was also amended effective December 1, 2022 to increase the cash payment to $25,000 per month. The Company incurred related consulting expenses of $105,000 during the year ended December 31, 2022. There were no related consulting expenses incurred during the year ended December 31, 2021. As of December 31, 2022, $25,000 of the related consulting expenses were unpaid. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Stock-based Compensation [Abstract] | |
Stock-based Compensation | 7. Stock-based Compensation Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of comprehensive income (loss) for the periods indicated below (in thousands): December 31, 2022 2021 General and administrative $ 1,060 $ 1,116 Research and development 747 798 Total stock-based compensation $ 1,807 $ 1,914 Ocuphire Stock Options Inducement Plan On February 22, 2021, the Company adopted the Ocuphire Pharma, Inc. 2021 Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 325,258 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. 2020 Equity Incentive Plan In November 2020, the stockholders of the Company approved the 2020 Equity Incentive Plan (the “2020 Plan”) for stock-based awards. Under the 2020 Plan, (i) 1,000,000 new shares of common stock were reserved for issuance and (ii) up to 70,325 additional shares of common stock may be issued, consisting of (A) shares that remain available for the issuance of awards under prior equity plans and (B) shares of common stock subject to outstanding stock options or other awards covered by prior equity plans that have been cancelled or expire on or after the date that the 2020 Plan became effective. Under the 2020 Plan, the shares reserved automatically increase on January 1 of each year, for a period of not more than ten years from the date the 2020 Plan is approved by the stockholders of the Company, commencing on January 1, 2021 and ending on (and including) January 1, 2030, by an amount equal to 5% of the shares of common stock outstanding as of December 31st of the preceding calendar year. The 2020 Plan permits the grant of incentive and nonstatutory stock options, appreciation rights, restricted stock, restricted stock units, performance stock and cash awards, and other stock-based awards 2018 Equity Incentive Plan Prior to the 2020 Plan, the Company had adopted a 2018 Equity Incentive Plan (the “2018 Plan”) in April 2018 under which 1,175,000 shares of the Company’s common stock were reserved for issuance to employees, directors and consultants. Upon the effective date of the 2020 Plan, no additional shares were available for issuance under the 2018 Plan General During the years ended December 31, 2022 and 2021, 893,305 and 420,300 stock options were granted to officers, directors, employees and consultants, respectively, generally vesting over a five (5) to forty-eight (48) month period. The Company recognized $1.7 million and $1.8 million in stock-based compensation expense related to stock options during the years ended December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021, 24,309 and 73,442 stock options were exercised, respectively, with an intrinsic value of $59,000 and $345,000, respectively. The following table summarizes the Company’s stock option plan activity: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (1) (in thousands) Outstanding at December 31, 2020 1,784,198 $ 2.17 8.87 $ 7,744 Granted 420,300 $ 5.72 — — Exercised (73,442 ) $ — — — Forfeited/Cancelled (34,220 ) $ — — — Outstanding at December 31, 2021 2,096,836 $ 2.97 8.20 $ 2,795 Granted 893,305 $ 2.64 Exercised (24,309 ) $ 1.09 Forfeited/Cancelled (29,788 ) $ 6.21 Outstanding at December 31, 2022 2,936,044 $ 2.87 7.82 $ 3,314 Vested and expected to vest at December 31, 2022 2,936,044 $ 2.87 7.82 $ 3,314 Vested and exercisable at December 31, 2022 1,723,792 $ 2.56 7.07 $ 1,680 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of our common stock as of December 31, 2022 and 2021 of $3.53 and $3.73 per share, respectively. The weighted average fair value per share of options granted during the years ended December 31, 2022 and 2021 was $2.06 and $4.36, respectively. The Company measures the fair value of stock options with service-based vesting criteria to employees, directors, consultants and directors on the date of grant using the Black-Scholes option pricing model. The Company does not have adequate history to support an internal calculation of volatility and expected term. As such, the Company has used a weighted average volatility considering the volatilities of several guideline companies. For purposes of identifying similar entities (guideline companies), the Company considered characteristics such as industry, length of trading history, and stage of life cycle. The average expected life of the options was based on the contractual term for agreements that allow for exercise of vested options through the end of the contractual term upon termination of continuous service, and for all other agreements, was based on the mid‑point between the vesting date and the end of the contractual term according to the “simplified method” as described in Staff Accounting Bulletin 110. The risk‑free interest rate is determined by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. The Company records forfeitures when they occur. The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The weighted average assumptions used in the Black-Scholes option pricing model are as follows during the years ended December 31, 2022 and 2021: 2022 2021 Expected stock price volatility 97.4 % 98.1 % Expected life of options (years) 5.8 5.8 Expected dividend yield 0 % 0 % Risk free interest rate 2.3 % 0.9 % During the years ended December 31, 2022 and 2021, 488,621 and 468,301 stock options vested, respectively. The weighted average fair value per share of options vesting during the years ended December 31, 2022 and 2021 was $3.29 and $3.49, respectively. During the years ended December 31, 2022 and 2021, 29,788 and 34,220 stock options were forfeited, respectively. As of December 31, 2022, 894,920 shares in the aggregate were available for future issuance under the 2020 Plan and Inducement Plan. Unrecognized stock-based compensation cost was $2.6 million as of December 31, 2022. The unrecognized stock-based expense is expected to be recognized over a weighted average period of 1.2 years. Restricted Stock Awards On November 11, 2020, the Company granted 40,000 restricted stock awards (“RSAs”) that vested on January 8, 2021. There were no RSAs granted during the years ended December 31, 2022 or 2021. The stock-based compensation expense attributed to the RSAs during each of the years ended December 31, 2022 and 2021 was $0 and $22,000, respectively. A summary of RSA activity is as follows for the year ended December 31, 2021: Number of Shares Non-vested at December 31, 2020 40,000 Granted — Vested (40,000 ) Non-vested at December 31, 2021 — Common Stock Issued for Services The Company granted common stock for services in the amount of 74,396 and 21,414 shares of common stock during the years ended December 31, 2022 and 2021, respectively, to four and two board members during those periods, respectively, who elected to receive their board retainers in the form of stock for services. The stock-based compensation related to these services amounted to $154,000 and $108,000 during the years ended December 31, 2022 and 2021, respectively. Former Rexahn Options Following the closing of the Merger, 123 unexercised and vested options to purchase common stock granted under the Rexahn Pharmaceuticals Stock Option Plan, as amended (the “Rexahn 2003 Plan”, and together with the Rexahn 2013 Plan, the “Prior Plans”) were outstanding. As of December 31, 2022, none of the former Rexahn options remained outstanding under the Prior Plans. During the year ended December 31, 2022, 82 of the former Rexahn options expired. |
Apexian Sublicense Agreement
Apexian Sublicense Agreement | 12 Months Ended |
Dec. 31, 2022 | |
Apexian Sublicense Agreement [Abstract] | |
Apexian Sublicense Agreement | 8. Apexian Sublicense Agreement On January 21, 2020, as amended on June 4, 2020, the Company entered into a sublicense agreement (the “Sublicense Agreement”) with Apexian, pursuant to which it obtained exclusive worldwide patent and other intellectual property rights that constitute a Ref-1 Inhibitor program relating to therapeutic applications to treat disorders related to ophthalmic and diabetes mellitus conditions. The lead compound in the Ref-1 Inhibitor program is APX3330, which the Company intends to develop as an oral pill therapeutic to treat diabetic retinopathy and diabetic macular edema initially, and potentially later to treat wet age-related macular degeneration. The Company agreed to make one-time milestone payments under the Sublicense Agreement for each of the first ophthalmic indication and the first diabetes mellitus indication for the Development and Regulatory milestones, and once for each of the Sales milestones. These milestone payments include (i) payments for specified developmental and regulatory milestones (including completion of the first Phase 2 trial that meets a primary endpoint and the first Phase 3 pivotal trial in the United States, and filing and achieving regulatory approval from the FDA for the first New Drug Application for a compound) totaling up to $11 million in the aggregate and (ii) payments for specified sales milestones of up to $20 million in the aggregate, which net sales milestone payments are payable once, upon the first achievement of such milestone. Lastly, the Company also agreed to make a royalty payment equal to a single-digit percentage of its net sales of products associated with the covered patents under the Sublicense Agreement. If it is not terminated pursuant to its terms, the Sublicense Agreement shall remain in effect until expiration of the last to expire of the covered patents. None of the milestone or royalty payments, were triggered or deemed probable as of December 31, 2022. |
Stockholder Equity
Stockholder Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholder Equity [Abstract] | |
Stockholder Equity | 9. Stockholder Equity At-The-Market Program On February 4, 2021, Ocuphire filed a Form S-3 shelf registration under the Securities Act of 1933 which was declared effective by the SEC on February 12, 2021 (the “2021 Shelf”) under which the Company may offer and sell, from time to time in its sole discretion, securities having an aggregate offering price of up to $125 million. In connection with the 2021 Shelf, on March 11, 2021, Ocuphire entered into a sales agreement with JonesTrading Institutional Services LLC (“JonesTrading”) under which the Company may offer and sell, from time to time at its sole discretion, to or through JonesTrading, acting as agent and/or principal, shares of its common stock having an aggregate offering price of up to $40 million (the “ATM”). During the years ended December 31, 2022 and 2021, 1,848,980 and shares of common stock were sold under the ATM for aggregate gross proceeds in the amount of $4.4 million and $13.5 million, respectively, before deducting issuance expenses, including the placement agent’s fees, legal and accounting expenses, in the amount of $133,000 and $0.4 million, respectively. Registered Direct Offering On June 4, 2021, the Company entered into a placement agency agreement for a registered direct offering (“RDO”) with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the placement agency agreement, AGP on June 8, 2021 sold an aggregate of shares of the Company’s common stock and warrants to purchase shares of the Company’s common stock (the “RDO Warrants”) at an offering price of $4.875 per one share and RDO Warrants, for gross proceeds of approximately $15.0 million, before AGP’s fees and related offering expenses in the amount of approximately $1.1 million. The proceeds were allocated between the relative fair values of common stock and warrants at the sale date. The purchase agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties and termination provisions. The RDO was made pursuant to the Company’s 2021 shelf registration. The RDO Warrants have an exercise price of $6.09 per share, are exercisable from the initial issuance date of June 8, 2021, and will expire following the initial issuance date. As of December 31, 2022, RDO Warrants were outstanding. Subject to limited exceptions, a holder of a RDO Warrant will not have the right to exercise any portion of its RDO Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise; provided, however, that upon prior notice to the Company, the holder may increase or decrease the beneficial ownership limitation, provided further that in no event shall the beneficial ownership limitation exceed 9.99%. |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2022 | |
License and Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 10. License and Collaboration Agreements Nyxol License Agreement On November 6, 2022, the Company entered into the Nyxol License Agreement, pursuant to which it granted Famy an exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize (i) Nyxol for treating (a) reversal of mydriasis, (b) night vision disturbances or dim light vision, and (c) presbyopia, and (ii) Nyxol and low dose pilocarpine for treating presbyopia (together, the “Nyxol Products”) worldwide except for certain countries and jurisdictions in Asia (the “Viatris Territory”). The Company retains the exclusive right to develop, manufacture, have manufactured, import, export and commercialize the Product outside of the Viatris Territory. In 2023, Famy was acquired by Viatris Inc., and Viatris has assumed all of Famy’s obligations under the Nyxol License Agreement. Under the terms of the Nyxol License Agreement, the Company will develop the Nyxol Products in the United States in partnership with Viatris, and Viatris will be responsible for developing the Nyxol Products in countries and jurisdictions in the Viatris Territory outside of the United States. Viatris will reimburse the Company for budgeted costs related to the development of the Nyxol Products through FDA approval. The parties established a joint steering committee, which oversees and makes decisions regarding the development of the Nyxol Products. The committee is composed of an equal number of representatives of Viatris and Ocuphire. Viatris will commercialize the Nyxol Products in the Viatris Territory for each indication that receives regulatory approval. Pursuant to the Nyxol License Agreement, the Company received a one-time non-refundable cash payment of $35 million in November 2022 for the exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize the Nyxol Products in the Viatris Territory. In addition, with respect to each Nyxol Product, the Company will be eligible to receive potential additional payments of up to $130 million in the aggregate upon achieving certain specified regulatory or net sales milestones, with the first potential payment of $10 million to be made following approval by the FDA of Nyxol for reversal of mydriasis. The Company will also receive tiered royalties, starting at low double-digit royalties up to low twenty percent royalties, based on the aggregate annual net sales of all Nyxol Products in the United States, and will receive low double-digit royalties based on all annual net sales in the Viatris Territory outside of the United States. The royalty payments will continue on a country-by-country basis from the date of the first commercial sale of the first Nyxol Product in a country of the Viatris Territory until December 31, 2040. Either party may terminate the Nyxol License Agreement upon written notice in the case of the other party’s material breach (subject to applicable cure periods) or if the other party becomes subject to an insolvency event. In addition, the Company may terminate the agreement in its entirety if Famy, Viatris or their affiliates commence an action challenging the validity, enforceability or scope of any of Ocuphire’s patents that are exclusively licensed under the Nyxol License Agreement. Additionally, if Viatris determines not to pursue development or commercialization of a Product in a country or jurisdiction in the Viatris Territory, Viatris may terminate the license with respect to such Product in such country or jurisdiction. Both Ocuphire and Viatris have agreed to indemnify the other party against certain losses and expenses relating to any breach of the indemnifying party’s obligations, representations, warranties or covenants under the Nyxol License Agreement. The Nyxol License Agreement was accounted for under the provisions of ASC 606. In accordance with the p rovisions under ASC 606, the Company identified two distinct performance obligations: (1) the license to its intellectual property (“license transfer”) and (2) research and development services. The aggregate transaction price associated with the Nyxol License Agreement was $40.2 million which comprised the Initial License Transfer fee of $35.0 million and the estimated $5.2 million payment anticipated under the research and development services that were not subject to cancellation. The transaction price was allocated between performance obligations based on their relative standalone selling price (“SSP”). The SSP for the license transfer and for the research and development services was determined to be $ 287.8 million and $5.2 million, respectively. The SSP for the license tran sfer was determined based on a discounted royalty cash flow approach, taking into consideration assumptions, including Recognition of Revenue The Company determined that the licenses transferred represented functional intellectual property. As such, the revenue related to the licenses was recognized at the point in time in which the license/know-how was delivered to Famy which occurred during the fourth quarter of 2022. The Company determined that revenue related to the research and development services was to be recognized over time as the services are rendered based on an estimated percentage of completion input model. Regulatory Milestones under the Nyxol License Agreement The Company has evaluated the regulatory milestones that may be received in connection with the Nyxol License Agreement. There is uncertainty that the events to obtain the regulatory milestones will be achieved given the nature of clinical development and the stage of the development of the Products. The remaining regulatory milestones will be constrained until it is probable that a significant revenue reversal will not occur. Sales Milestone and Royalty Payments Sales milestones and royalties relate predominantly to a license of intellectual property granted to Famy and are determined by sales or usage-based thresholds. The sales milestones and royalties are accounted for under the royalty recognition constraint and will be accounted for as constrained variable consideration. The Company applies the royalty recognition constraint for each commercial milestone and will not recognize revenue for each until the subsequent sale of a licensed product (achievement of each) occurs. With the exception of the license transfer and the research and development services obligations, each of the remaining regulatory and sales milestone performance obligations and royalty payments were fully constrained as of December 31, 2022. A reconciliation of the closing balance of the contract asset associated with the Nyxol License Agreement is as follows as of December 31, 2022 (in thousands): Contract Asset Balance as of December 31, 2021 $ — Revenue recognized – license transfer 39,519 Execution of Nyxol License Agreement and one-time non-refundable payment (35,000 ) Revenue recognized – research and development services 331 Reclassification to accounts receivable related to costs billed under the Nyxol License Agreement (1,298 ) Balance as of December 31, 2022 $ 3,552 The remaining amounts in the contract asset as of December 31, 2022 attributed to the research and development services are expected to be settled during the first half of 2023. BioSense License and Assignment Agreement On March 10, 2020, pre-Merger, Rexahn entered into an amendment to its collaboration and license agreement, (as amended, the “BioSense License and Assignment Agreement”) with BioSense to advance the development and commercialization of RX-3117 for all human uses in the Republic of Singapore, China, Hong Kong, Macau, and Taiwan (the “BioSense Territory”). Under the terms of the BioSense License and Assignment Agreement, the Company (i) granted BioSense an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 as a single agent for all human uses in the BioSense Territory and (ii) assigned and transferred all of the former Rexahn patents and patent applications related to RX-3117 in the BioSense Territory. The upfront payment consisted of an aggregate of $1,650,000, of which $1,550,000 was paid to Rexahn prior to the Merger.During the year ended December 31, 2021, the Company satisfied a performance obligation for the $100,000 payment that was remaining and recorded this amount as license and collaborations revenue. Under the BioSense License and Assignment Agreement, the Company is eligible to receive additional milestone payments in an aggregate of up to $84,500,000 upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties at low double-digit rates on annual net sales in the BioSense Territory. The Company determined that none of the milestone payments under the BioSense License and Assignment Agreement were probable of payment as of December 31, 2022, and as a result, no revenue related to the milestones was recognized as the achievement of events entitling the Company to any milestone payments were highly susceptible to factors outside of the Company’s control. Future sales-based royalties related to the exclusive license to develop RX-3117 will be recognized in the period the underlying sales transaction occurs. Payments received under the BioSense License and Assignment Agreement are subject to the CVR Agreement described in Note 2 – Merger. Processa License Agreement On June 16, 2021, the Company entered into a license agreement (the “Processa License Agreement”) with Processa Pharmaceuticals, Inc. (“Processa”), pursuant to which the Company has agreed to grant Processa an exclusive license to develop, manufacture and commercialize RX-3117 globally, excluding the BioSense Territory. As consideration for the Processa License Agreement, the Company received an upfront payment in July 2021 consisting of 44,689 shares of Processa common stock with a fair value of $289,000 (at the contract date) and a $200,000 cash payment.The Company was restricted from selling the Processa common stock for a period of one year ending June 16, 2022. As additional consideration, Processa will make payments to the Company upon the achievement of certain development and regulatory milestones, which primarily consist of dosing a patient in pivotal trials or having a drug indication approved by a regulatory authority in the United States or another country. In addition, Processa will pay the Company mid-single-digit royalties based on annual sales under the license and will make one-time sales milestone payments based on the achievement during a calendar year of certain thresholds for annual sales. Processa is also required to give the Company 32% of any milestone payments received based on any sub-license agreement Processa may enter into with respect to the Processa License Agreement.The Company determined that none of the milestone payments under the Processa License Agreement were probable of payment as of December 31, 2022, and as a result, no revenue related to the milestones was recognized, as the achievement of events entitling the Company to any milestone payments were highly susceptible to factors outside of the Company’s control. Processa is required to use commercially reasonable efforts, at its sole cost and expense, to conduct development activities in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a clinical trial of a licensed product prior to the three (3) year anniversary of the effective date; and (ii) first patient administered drug in a pivotal clinical trial of a licensed product or first patient administered drug in a clinical trial for a second indication of a licensed product prior to the five (5) year anniversary of the effective date. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 120-day opportunity to cure such breach, and Processa may terminate the agreement for any reason upon 120 days prior written notice to Ocuphire. As of December 31, 2021, the Company had fulfilled its performance obligations with respect to the upfront payment under the Processa License Agreement and had recognized the associated licensing revenue in connection with the payment. Payments received under the Processa License Agreement will be subject to the CVR Agreement described in Note 2 – Merger. |
Net income (loss) per share
Net income (loss) per share | 12 Months Ended |
Dec. 31, 2022 | |
Net income (loss) per share [Abstract] | |
Net income (loss) per share | 11. Net income (loss) per share Basic income (loss) per share of common stock is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s warrants, stock options and restricted stock awards, while outstanding, are considered common stock equivalents for this purpose. Diluted earnings is computed utilizing the treasury method for the warrants, stock options and restricted stock. Incremental common stock equivalents that were antidilutive were excluded in calculating diluted income per share. For the year ended December 31, 2021, no common stock equivalents were included in the diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the prior year period. The following table presents the computation of weighted average common shares considered in the computation of diluted net income (loss) per share: 2022 2021 Denominator (weighted average shares) Basic common shares outstanding 19,931,080 14,852,745 Dilutive stock options 589,165 — Dilutive warrants 76,967 — Diluted common shares outstanding 20,597,212 14,852,745 The following potential common shares were not considered in the computation of diluted net income (loss) per share as their effect would have been anti-dilutive for the year end periods presented below: 2022 2021 Series A, Series B and RDO warrants 7,145,201 7,282,999 Stock options 2,346,879 2,096,836 Restricted stock awards including pending issuances of stock for services — 6,970 Former Rexahn warrants 60,713 66,538 Former Rexahn options — 82 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes [Abstract] | |
Income Taxes | 12. Income Taxes The effective tax rate for the years ended December 31, 2022 and 2021 was 1.7 percent and zero percent, respectively. A reconciliation of income tax computed at the statutory federal income tax rate to the provision (benefit) for income taxes included in the accompanying statements of comprehensive income (loss) is as follows for the years ended December 31, 2022 and 2021: 2022 2021 Income tax (benefit) provision at federal statutory rate 21.0 % (21.0 )% Valuation allowance (21.4 ) 11.9 State income tax, net of federal benefit 4.9 (4.8 ) Warrants — 15.3 Stock options 0.4 (0.1 ) Research and development (3.1 ) (1.1 ) Other (0.1 ) (0.2 ) Effective tax rate 1.7 % — % The components of income tax provision (benefit) consisted of the following for the years ended December 31, 2022 and 2021 (in thousands): 2022 2021 Income (loss) before income taxes: $ 18,203 $ (56,693 ) Current: Federal $ 279 $ — State 36 — Total current tax provision (benefit) 315 — Deferred: Federal — — State — — Total tax provision (benefit ) $ 315 $ — Significant components of the Company’s deferred tax assets and liabilities are summarized in the tables below as of December 31, 2022 and 2021 (in thousands): 2022 2021 Deferred tax assets: Federal and state operating loss carryforwards $ 13,087 $ 19,244 Acquired intangibles 547 547 Deferral of research and development costs 2,820 — Organizational costs 7 7 Other 62 18 Stock-based compensation 1,152 811 Research and development credit carryforward 731 1,035 Subtotal 18,406 21,662 Valuation allowance (17,770 ) (21,662 ) Total deferred tax assets, net of valuation allowance 636 — Deferred tax liabilities: Deferred revenue (636 ) — Total deferred tax liabilities (636 ) — Net deferred tax assets $ — $ — As of December 31, 2022 and 2021, the Company had gross deferred tax assets of approximately $18.4 million and $21.7 million, respectively. Realization of the deferred tax assets is primarily dependent upon future taxable income, if any, the amount and timing of which are uncertain. The Company has cumulative pre‑tax losses and faces significant challenges to becoming profitable in the future. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance As of December 31, 2022 and 2021, the tax effect of the Company’s federal net operating loss carryforwards was approximately $10.9 million and $15.7 million, respectively. The Company had federal research credit carryforwards as of December 31, 2022 and 2021 of approximately $0.7 million and $1.0 million, respectively. The federal net operating loss carryforwards will not expire and the tax credit carryforwards will begin to expire in 2041 if not utilized. As of December 31, 2022 and 2021, the Company had state net operating loss carryforwards with a tax effect of approximately $2.2 million and $3.6 million, respectively. The Company did not have any state research credit carryforwards as of December 31, 2022 and 2021. The state net operating loss carryforwards will begin to expire in 2028. The Company utilized federal and state net operating tax carryforwards with a tax effect in the amount of $4.8 million and $1.4 million, respectively, to offset taxable income for the year ended December 31, 2022. In addition, the Company also utilized its federal research credit carryforwards in the amount of $0.9 million to partially offset its tax liability for the year ended December 31, 2022. Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 and Section 383 of the Internal Revenue Code of 1986, as amended, and similar state provisions. Generally, in addition to certain entity reorganizations, the limitation applies when one or more “5-percent shareholders” increase their ownership, in the aggregate, by more than 50 percentage points over a 3 year testing period, or beginning the day after the most recent ownership change, if shorter. The annual limitation may result in the expiration of net operating losses and credits before utilization. As a result of the Merger, the Company recorded deferred tax assets of $10.3 million relating to net operating loss carryforwards which were fully offset by a valuation allowance. The $10.3 million net deferred tax assets recorded in relation to the Merger did not include federal and state net operating loss carryforwards that were estimated to expire under Internal Revenue Code Sections 382 as a result of the Merger. The Company has not yet evaluated the impact of Section 382 and Section 383 on its remaining tax attributes that were generated by Ocuphire since the formation of the Company in 2018. The Company recognizes interest and/or penalties related to uncertain tax positions in income tax expense. There were no uncertain tax positions as of December 31, 2022 and 2021, and as such, no interest or penalties were recorded to income tax expense. The Company’s corporate returns are subject to examination beginning with the 2019 tax year for federal income tax purposes and 2018 for state income tax purposes. |
Deferred Compensation Plan
Deferred Compensation Plan | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Compensation Plan [Abstract] | |
Deferred Compensation Plan | 13. Deferred Compensation Plan Effective October 1, 2021, the Company began offering a 401(k) plan (“401K Plan”) to its employees. All employees are eligible to participate in the 401K Plan. The Company makes matching contributions equal to 100% on the first 3% of compensation that is deferred as an elective deferral and an additional 50% on the next 2% of compensation. The Company’s matching contributions are made on a monthly basis. During the years ended December 31, 2022 and 2021, the Company contributed $76,000 and $15,000 to the 401K Plan, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events 2020 Plan Evergreen Provision Under the 2020 Plan, the shares reserved automatically increase on January 1 of each year, for a period of not more than ten years from the date the 2020 Plan is approved by the stockholders of the Company, commencing on January 1, 2021 and ending on (and including) January 1, 2030, by an amount equal to 5% of the shares of common stock outstanding as of December 31 of the preceding calendar year. Notwithstanding the foregoing, the Board of Directors may act prior to January 1 of a given year to provide that there will be no January 1 increase in the share reserve for such year or that the increase in the share reserve for such year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding sentence. On January 1, 2023, 1,043,066 shares were added to the 2020 Plan as a result of the evergreen provision. |
Company Description and Summa_2
Company Description and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | |
Nature of Business | Nature of Business Ocuphire Pharma, Inc. (the “Company” or “Ocuphire”) is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. Ocuphire’s pipeline currently includes two small molecule product candidates targeting several of such indications. In November 2022, the Company entered into a license and collaboration agreement (the “Nyxol License Agreement”) with FamyGen Life Sciences, Inc. (acquired by Viatris, Inc. (“Viatris”) in January 2023) pursuant to which it granted Viatris an exclusive license to develop, manufacture, import, export and commercialize its product candidate phentolamine ophthalmic solution 0.75% (Nyxol® Eye Drops or “Nyxol”). Nyxol is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. Nyxol can potentially be used across multiple indications such as treatment of pharmacologically-induced mydriasis (“RM”) (dilation of the pupil), presbyopia (age-related blurry near vision) and dim light or night vision disturbances (“DLD”) (halos, glares and starbursts). The Company’s second product candidate, APX3330, is a twice-a-day oral tablet designed to target multiple pathways relevant to retinal and choroidal (the vascular layer of the eye) diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual blindness. The Company has also in-licensed APX2009 and APX2014, which are second-generation product candidates and analogs of APX3330. License and collaborations revenue to date was derived from a one-time non-refundable payment and reimbursement of expenses earned under the Nyxol License Agreement, and to a much lesser degree, from license agreements with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc. (“Processa”) in connection with the Rexahn RX-3117 drug compound. The Company anticipates that it will recognize revenue as it earns reimbursement for research and development services in connection with the Nyxol License Agreement and it may earn additional revenues from future potential milestone and royalty payments from the agreements with Viatris, BioSense, Processa, or from other license agreements entered into the future; however, the attainment of milestones or level of sales required to earn royalty payments is highly uncertain. Outside of the license and collaborations revenue, the Company does not expect to generate significant revenue unless or until regulatory approval is obtained and commercialization begins for Nyxol or APX3330. Management plans to continue financing the Company’s operations primarily through additional issuances of the Company’s equity and debt securities or through collaborations or partnerships with other companies. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate part or all of its research and development programs. |
Reverse Merger with Rexahn | Reverse Merger with Rexahn On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”), Razor Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rexahn (“Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization, as amended on June 29, 2020 (as amended, the “Merger Agreement”), pursuant to which, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub would merge with and into Ocuphire, with Ocuphire continuing as a wholly-owned subsidiary of Rexahn and the surviving corporation of the merger (the “Merger”). The Merger closed on November 5, 2020. Upon completion of the Merger, Rexahn changed its name to Ocuphire Pharma, Inc. and changed its ticker symbol on the Nasdaq Capital Market to “OCUP”. The Company’s headquarters is located in Farmington Hills, Michigan. |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting standards generally accepted in the United States of America (“GAAP”). On December 31, 2021, the Company merged its wholly owned subsidiary, OcuSub Inc, with and into the Company, with the Company remaining as the surviving entity. The merger of the Company’s wholly owned subsidiary did not have a financial impact to the periods presented. Upon close of this merger, the Company did not have any remaining entities that required consolidation for financial statement reporting purposes. |
Liquidity | Liquidity The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern. From its inception, the Company has devoted substantially all of its efforts to drug discovery and development and conducting clinical trials. The Company entered into the Nyxol License Agreement, and the one-time In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the ultimate outcome of these actions to generate the liquidity ultimately required. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. |
Segment Information | Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development and commercialization of products related to vision performance and health. Accordingly, the Company has a single reporting segment. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of deposit to be cash equivalents. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. As of December 31, 2022, the Company’s cash was held by two large financial institutions in the United States. Amounts on deposit may at times exceed federally insured limits. As of December 31, 2022, the Company had deposits that exceeded federally insured amounts by approximately $42.1 million. |
Short-term Investments | Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and are recorded on a settlement date basis. The Company’s investments are comprised of equity securities, which in accordance with the fair value hierarchy described below are recorded at fair value using Level l inputs on the balance sheets. Subsequent changes in fair values are recorded in other expense, net on the consolidated statements of comprehensive income (loss). The Company classifies investments available to fund current operations as current assets on its balance sheets. The Company did not recognize any impairments on its investments to date through December 31, 2022. |
Revenue Recognition | Revenue Recognition The Company follows the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers . The guidance provides a five-step model to determine how revenue is recognized. The Company has entered into license agreements which have revenue recognition implications (See Note 10 – License and Collaboration Agreements). In determining the appropriate amount of revenue to be recognized, the Company performs the following steps: (i) identification of the contracts with a customer; (ii) determination of the performance obligations in the contract; (iii) measurement of the transaction price, including potential constraints on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated stand-alone selling prices; and (v) recognition of revenue when (or as) the Company satisfies a performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606. Performance obligations may include license rights, development and other services. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation based on the relative standalone selling prices of the promised goods or service underlying each performance obligation. Licenses of intellectual property and research and development services: Milestone payments: Royalties: |
Contract Asset | Contract Asset The Company recognizes a contract asset when goods or services are transferred to the customer before the customer pays or before payment is due, excluding any amounts presented as an accounts receivable. The Company recorded a contract asset in connection with a license and collaboration agreement in the amount of $3.6 million as of December 31, 2022. See Note 10 - License and Collaboration Agreements. |
Accounts Receivable and Allowances for Doubtful Accounts | Accounts Receivable and Allowances for Doubtful Accounts The Company records a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable. In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable, its historical write-offs, the credit worthiness of each customer, and general economic conditions. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance. The Company has not incurred any bad debt expense during the years ended December 31, 2022 or 2021 and no allowance for doubtful accounts has been recorded during the periods presented. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses (“G&A”) consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, settlement costs with third parties and other services provided by business consultants. |
Research and Development | Research and Development Research and development expenses (“R&D”) consist of costs incurred in performing research and development activities, including compensation for research and development employees and consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, fees paid to external service providers that conduct certain research and development, and an allocation of R&D related overhead expenses. R&D costs include costs that are reimbursed under the Nyxol License Agreement. |
Other Expense, net | Other Expense, net Other expense, net reflected in this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former Rexahn shareholders. In addition, other expense, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in connection with grants and other sources when they occur. |
Stock-based Compensation | Stock-based Compensation The Company accounts for stock-based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) ASC 718, Compensation — Stock Compensation |
Warrant Liabilities | Warrant Liabilities The Company issued Series A Warrants in connection with the Pre-Merger Financing (see Note 3 – Pre-Merger Financing) and assumed Rexahn warrants issued prior to the Merger. The Company accounts for these warrants as a liability while outstanding at fair value during periods when certain provisions preclude equity accounting treatment for these instruments. Additionally, issuance costs associated with the warrants classified as liabilities were expensed as incurred and reflected as interest expense in the accompanying consolidated statements of comprehensive income (loss). The change in fair value of the warrant liabilities while outstanding were recognized as a component of the fair value change in warrant liabilities line item in the consolidated statements of comprehensive income (loss). |
Fair Value Measurements | Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy: • Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets; • Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and • Level 3 inputs: Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. As of December and the fair values of cash and cash equivalents, accounts receivable, contract asset, prepaid and other assets, accounts payable, accrued expenses and short-term loan, while outstanding, approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the short-term investments was based on observable Level inputs in the form of quoted market prices from a major stock exchange. The fair value of the warrant liabilities, while outstanding, was based on cash flow models discounted at current implied market rates evidenced in recent arms-length transactions representing expected returns by market participants for similar instruments and were based on Level inputs. There were no transfers between fair value hierarchy levels during the years ended December 31, 2022 and 2021. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 49 $ 49 $ — $ — Total assets at fair value $ 49 $ 49 $ — $ — As of December 31, 2021 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 219 $ 219 $ — $ — Total assets at fair value $ 219 $ 219 $ — $ — The following table provides a roll-forward of investments measured at fair value on a recurring basis using observable level 1 inputs for the year ended December 31, 2022 and 2021 (in thousands): 2022 2021 Short-term investments Balance as of beginning of period $ 219 $ — Receipt of investments related to license agreement — 289 Unrealized loss (170 ) (70 ) Balance as of end of period $ 49 $ 219 The following table provides a roll-forward of the warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the year ended December 31, 2021 (in thousands): 2021 Warrant liabilities Balance as of beginning of period $ 27,964 Change in fair value of warrant liabilities 33,829 Reclassification of warrants from liability to equity (61,793 ) Balance as of end of period $ — The fair value of the warrant liabilities associated with the Rexahn warrants was de minimis during the years ended December 31, 2022 and 2021. See Note 2 - Merger. There were no financial instruments measured on a non-recurring basis for any of the periods presented. |
Income Taxes | Income Taxes The Company utilizes the liability method of accounting for income taxes as required by ASC 740, Income Taxes |
Property and Equipment, net | Property and Equipment, net Property and equipment, net is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. Equipment and furniture are depreciated over a five-year estimated useful life. Tangible assets acquired for research and development activities which have alternative use are capitalized and depreciated over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, “ Financial Instruments – Credit Losses” In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this ASU are effective for public business entities that meet the definition of a Securities and Exchange Commission (“SEC”) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company does not expect that the adoption of this ASU on January 1, 2023 on its consolidated financial statements will be material . In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency of government assistance including the disclosure of the types of assistance, an entity’s accounting for the assistance, and the effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted this guidance on January 1, 2022 and it did not have a material impact to the consolidated financial statements. |
Company Description and Summa_3
Company Description and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | |
Fair Value of Financial Instruments Measured on a Recurring Basis | The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 49 $ 49 $ — $ — Total assets at fair value $ 49 $ 49 $ — $ — As of December 31, 2021 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 219 $ 219 $ — $ — Total assets at fair value $ 219 $ 219 $ — $ — |
Fair Value, Investments Measured on a Recurring Basis | The following table provides a roll-forward of investments measured at fair value on a recurring basis using observable level 1 inputs for the year ended December 31, 2022 and 2021 (in thousands): 2022 2021 Short-term investments Balance as of beginning of period $ 219 $ — Receipt of investments related to license agreement — 289 Unrealized loss (170 ) (70 ) Balance as of end of period $ 49 $ 219 |
Warrant Liabilities Measured at Fair Value on a Recurring Basis | The following table provides a roll-forward of the warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the year ended December 31, 2021 (in thousands): 2021 Warrant liabilities Balance as of beginning of period $ 27,964 Change in fair value of warrant liabilities 33,829 Reclassification of warrants from liability to equity (61,793 ) Balance as of end of period $ — |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Supplemental Balance Sheet Information [Abstract] | |
Prepaid and Other Assets | Prepaid and other assets consist of the following (in thousands): December 31, 2022 2021 Prepaids $ 1,373 $ 1,243 Other 80 71 Total prepaids and other assets $ 1,453 $ 1,314 |
Property and Equipment, Net | Property and equipment held for use by category are presented in the following table (in thousands): December 31, 2022 2021 Equipment $ 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (19 ) (15 ) Property and equipment, net $ 6 $ 10 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2022 2021 Income taxes $ 315 $ — Payroll 782 488 Professional services 208 84 R&D services and supplies 212 1,081 Other 167 80 Total $ 1,684 $ 1,733 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stock-based Compensation [Abstract] | |
Stock-Based Compensation Expense | Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of comprehensive income (loss) for the periods indicated below (in thousands): December 31, 2022 2021 General and administrative $ 1,060 $ 1,116 Research and development 747 798 Total stock-based compensation $ 1,807 $ 1,914 |
Stock Option Plan Activity | The following table summarizes the Company’s stock option plan activity: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (1) (in thousands) Outstanding at December 31, 2020 1,784,198 $ 2.17 8.87 $ 7,744 Granted 420,300 $ 5.72 — — Exercised (73,442 ) $ — — — Forfeited/Cancelled (34,220 ) $ — — — Outstanding at December 31, 2021 2,096,836 $ 2.97 8.20 $ 2,795 Granted 893,305 $ 2.64 Exercised (24,309 ) $ 1.09 Forfeited/Cancelled (29,788 ) $ 6.21 Outstanding at December 31, 2022 2,936,044 $ 2.87 7.82 $ 3,314 Vested and expected to vest at December 31, 2022 2,936,044 $ 2.87 7.82 $ 3,314 Vested and exercisable at December 31, 2022 1,723,792 $ 2.56 7.07 $ 1,680 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of our common stock as of December 31, 2022 and 2021 of $3.53 and $3.73 per share, respectively. |
Weighted-Average Assumptions Used in Black-Scholes Option-pricing Model | The weighted average assumptions used in the Black-Scholes option pricing model are as follows during the years ended December 31, 2022 and 2021: 2022 2021 Expected stock price volatility 97.4 % 98.1 % Expected life of options (years) 5.8 5.8 Expected dividend yield 0 % 0 % Risk free interest rate 2.3 % 0.9 % |
Restricted Stock Awards Activity | A summary of RSA activity is as follows for the year ended December 31, 2021: Number of Shares Non-vested at December 31, 2020 40,000 Granted — Vested (40,000 ) Non-vested at December 31, 2021 — |
License and Collaboration Agr_2
License and Collaboration Agreements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
License and Collaboration Agreements [Abstract] | |
Reconciliation of Contract Asset Associated | A reconciliation of the closing balance of the contract asset associated with the Nyxol License Agreement is as follows as of December 31, 2022 (in thousands): Contract Asset Balance as of December 31, 2021 $ — Revenue recognized – license transfer 39,519 Execution of Nyxol License Agreement and one-time non-refundable payment (35,000 ) Revenue recognized – research and development services 331 Reclassification to accounts receivable related to costs billed under the Nyxol License Agreement (1,298 ) Balance as of December 31, 2022 $ 3,552 |
Net income (loss) per share (Ta
Net income (loss) per share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Net income (loss) per share [Abstract] | |
Computation of Weighted Average Common Shares | The following table presents the computation of weighted average common shares considered in the computation of diluted net income (loss) per share: 2022 2021 Denominator (weighted average shares) Basic common shares outstanding 19,931,080 14,852,745 Dilutive stock options 589,165 — Dilutive warrants 76,967 — Diluted common shares outstanding 20,597,212 14,852,745 |
Anti-dilutive Securities Excluded from Computation of Net Income (Loss) per Share | The following potential common shares were not considered in the computation of diluted net income (loss) per share as their effect would have been anti-dilutive for the year end periods presented below: 2022 2021 Series A, Series B and RDO warrants 7,145,201 7,282,999 Stock options 2,346,879 2,096,836 Restricted stock awards including pending issuances of stock for services — 6,970 Former Rexahn warrants 60,713 66,538 Former Rexahn options — 82 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes [Abstract] | |
Reconciliation of Statutory to Effective Income Tax Rate | A reconciliation of income tax computed at the statutory federal income tax rate to the provision (benefit) for income taxes included in the accompanying statements of comprehensive income (loss) is as follows for the years ended December 31, 2022 and 2021: 2022 2021 Income tax (benefit) provision at federal statutory rate 21.0 % (21.0 )% Valuation allowance (21.4 ) 11.9 State income tax, net of federal benefit 4.9 (4.8 ) Warrants — 15.3 Stock options 0.4 (0.1 ) Research and development (3.1 ) (1.1 ) Other (0.1 ) (0.2 ) Effective tax rate 1.7 % — % |
Components of Income Tax Provision (Benefit) | The components of income tax provision (benefit) consisted of the following for the years ended December 31, 2022 and 2021 (in thousands): 2022 2021 Income (loss) before income taxes: $ 18,203 $ (56,693 ) Current: Federal $ 279 $ — State 36 — Total current tax provision (benefit) 315 — Deferred: Federal — — State — — Total tax provision (benefit ) $ 315 $ — |
Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are summarized in the tables below as of December 31, 2022 and 2021 (in thousands): 2022 2021 Deferred tax assets: Federal and state operating loss carryforwards $ 13,087 $ 19,244 Acquired intangibles 547 547 Deferral of research and development costs 2,820 — Organizational costs 7 7 Other 62 18 Stock-based compensation 1,152 811 Research and development credit carryforward 731 1,035 Subtotal 18,406 21,662 Valuation allowance (17,770 ) (21,662 ) Total deferred tax assets, net of valuation allowance 636 — Deferred tax liabilities: Deferred revenue (636 ) — Total deferred tax liabilities (636 ) — Net deferred tax assets $ — $ — |
Company Description and Summa_4
Company Description and Summary of Significant Accounting Policies, Nature of Business (Details) | 12 Months Ended |
Dec. 31, 2022 Product | |
Nature of Business [Abstract] | |
Number of small molecule product candidates | 2 |
Company Description and Summa_5
Company Description and Summary of Significant Accounting Policies, Liquidity (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Nov. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Liquidity [Abstract] | |||
Cash and cash equivalents | $ 42,634 | $ 24,534 | |
Nyxol License Agreement [Member] | |||
Liquidity [Abstract] | |||
Non-refundable upfront payment received | $ 35,000 |
Company Description and Summa_6
Company Description and Summary of Significant Accounting Policies, Segment Information (Details) | 12 Months Ended |
Dec. 31, 2022 Segment | |
Segment Information [Abstract] | |
Number of operating segments | 1 |
Company Description and Summa_7
Company Description and Summary of Significant Accounting Policies, Concentration of Credit Risk (Details) $ in Millions | Dec. 31, 2022 USD ($) |
Concentration of Credit Risk [Abstract] | |
Deposits that exceeded federally insured amounts | $ 42.1 |
Company Description and Summa_8
Company Description and Summary of Significant Accounting Policies, Short-term Investments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Other than Temporary Impairment Losses, Investments [Abstract] | |
Impairments on investments | $ 0 |
Company Description and Summa_9
Company Description and Summary of Significant Accounting Policies, Contract Asset and Accounts Receivable and Allowances for Doubtful Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Contract Asset and Accounts Receivable and Allowances for Doubtful Accounts [Abstract] | ||
Contract asset (Note 10) | $ 3,552 | $ 0 |
Allowance for doubtful accounts | 0 | 0 |
Bad debt expense | $ 0 | $ 0 |
Company Description and Summ_10
Company Description and Summary of Significant Accounting Policies, Fair Value of Financial Instruments Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | ||
Transfers in into Level 3 | $ 0 | $ 0 |
Transfers out of Level 3 | 0 | 0 |
Recurring Basis [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 49 | 219 |
Recurring Basis [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 49 | 219 |
Recurring Basis [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 49 | 219 |
Recurring Basis [Member] | Level 1 [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 49 | 219 |
Recurring Basis [Member] | Level 2 [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 0 | 0 |
Recurring Basis [Member] | Level 2 [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 0 | 0 |
Recurring Basis [Member] | Level 3 [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 0 | 0 |
Recurring Basis [Member] | Level 3 [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | $ 0 | $ 0 |
Company Description and Summ_11
Company Description and Summary of Significant Accounting Policies, Equity Investments Measured at Fair Value (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Equity Investments [Abstract] | ||
Unrealized loss | $ (170) | $ (70) |
Recurring Basis [Member] | Level 1 [Member] | Short- term investments [Member] | ||
Equity Investments [Abstract] | ||
Balance as of beginning of period | 219 | 0 |
Receipt of investments related to license agreement | 0 | 289 |
Unrealized loss | (170) | (70) |
Balance as of end of period | $ 49 | $ 219 |
Company Description and Summ_12
Company Description and Summary of Significant Accounting Policies, Warrant Liabilities and Premium Conversion Derivatives Measured at Fair Value (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2022 | |
Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||
Reclassification of warrants from liability to equity | $ 61,793 | |
Level 3 [Member] | Warrant Liabilities [Member] | ||
Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||
Balance as of beginning of period | 27,964 | |
Change in fair value of warrant liabilities | 33,829 | |
Reclassification of warrants from liability to equity | (61,793) | |
Balance as of end of period | 0 | |
Nonrecurring Basis [Member] | ||
Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||
Financial instruments liabilities at fair value | $ 0 | $ 0 |
Company Description and Summ_13
Company Description and Summary of Significant Accounting Policies, Property and Equipment, net (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Equipment [Member] | |
Property and Equipment, net [Abstract] | |
Estimated useful life | 5 years |
Furniture [Member] | |
Property and Equipment, net [Abstract] | |
Estimated useful life | 5 years |
Merger, Contingent Value Rights
Merger, Contingent Value Rights Agreement (Details) | 12 Months Ended | |
Dec. 31, 2022 Milestone | Nov. 05, 2020 Milestone Right | |
Contingent Value Rights Agreement [Abstract] | ||
Contingent value rights payment period | 15 years | |
Sum of cash consideration paid by a third party | 75% | |
Parent IP deal period | 10 years | |
Number of milestones accrued | 0 | 0 |
Number of potential milestones | 0 | 0 |
Rexahn [Member] | ||
Contingent Value Rights Agreement [Abstract] | ||
Number of contingent value right received per common stock | Right | 1 | |
Rexahn [Member] | BioSense Global LLC [Member] | ||
Contingent Value Rights Agreement [Abstract] | ||
Percentage of payments received by Rexahn or its affiliates | 90% | |
Rexahn [Member] | Zhejiang HaiChang Biotechnology Co., Ltd [Member] | ||
Contingent Value Rights Agreement [Abstract] | ||
Percentage of payments received by Rexahn or its affiliates | 90% |
Merger, Former Rexahn Warrants
Merger, Former Rexahn Warrants (Details) - Rexahn [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Nov. 05, 2020 | |
Former Rexahn Warrants and Stock Options [Abstract] | ||
Number of warrants outstanding (in shares) | 60,713 | 231,433 |
Average remaining contractual life | 1 year | |
Minimum [Member] | ||
Former Rexahn Warrants and Stock Options [Abstract] | ||
Exercise price (in dollars per share) | $ 38.4 | |
Maximum [Member] | ||
Former Rexahn Warrants and Stock Options [Abstract] | ||
Exercise price (in dollars per share) | $ 136.8 |
Pre-Merger Financing (Details)
Pre-Merger Financing (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Jun. 29, 2020 USD ($) Director | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) | Nov. 19, 2020 $ / shares shares | Nov. 05, 2020 shares | |
Pre-Merger Financing [Abstract] | |||||
Fair value change of warrant liability and premium conversion derivatives | $ | $ 0 | $ (33,829) | |||
Rexahn [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Warrants outstanding (in shares) | shares | 60,713 | 231,433 | |||
Securities Purchase Agreement [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Number of directors | Director | 5 | ||||
Securities Purchase Agreement [Member] | Rexahn [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Number of directors | Director | 1 | ||||
Securities Purchase Agreement [Member] | Investors [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Total investment | $ | $ 21,150 | ||||
Securities Purchase Agreement [Member] | Directors [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Total investment | $ | $ 300 | ||||
Series A Warrants [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Exercise price (in dollars per share) | $ / shares | $ 4.4795 | ||||
Exercisable term | 5 years | ||||
Warrant issued (in shares) | shares | 5,665,838 | ||||
Series A Warrants [Member] | Risk-Free Interest Rate [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Percentage of measurement input | 0.004 | ||||
Series A Warrants [Member] | Expected Volatility [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Percentage of measurement input | 0.866 | ||||
Series A Warrants [Member] | Expected Term [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Expected life | 4 years 9 months 18 days | ||||
Series A Warrants [Member] | Expected Dividend Yield Rate [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Percentage of measurement input | 0 | ||||
Series A Warrants [Member] | Waiver Agreements [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Fair value change of warrant liability and premium conversion derivatives | $ | $ 33,800 | ||||
Series B Warrants [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Exercise price (in dollars per share) | $ / shares | $ 0.0001 | ||||
Remaining issuable shares (in shares) | shares | 0 | ||||
Warrants outstanding (in shares) | shares | 17,869 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 12 Months Ended | ||
May 06, 2021 USD ($) Investor shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Facility Lease [Abstract] | |||
Monthly base rent | $ 3,000 | ||
Rent expense | 39,000 | $ 116,000 | |
Expected rent payment for the year end 2023 | 36,000 | ||
Issuance of Settlement Shares [Abstract] | |||
Number of accredited investors | Investor | 3 | ||
Accredited Investor [Member] | General and Administrative Expense [Member] | |||
Issuance of Settlement Shares [Abstract] | |||
Fair value share settlement amount | $ 1,614,000 | ||
Common Stock [Member] | Accredited Investor [Member] | |||
Issuance of Settlement Shares [Abstract] | |||
Common stock issued (in shares) | shares | 350,000 | ||
Rexahn [Member] | |||
Facility Lease [Abstract] | |||
Monthly base rent | 13,000 | ||
Rent expense | $ 39,000 | $ 116,000 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information, Prepaid and Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid and Other Assets [Abstract] | ||
Prepaids | $ 1,373 | $ 1,243 |
Other | 80 | 71 |
Total prepaids and other assets | $ 1,453 | $ 1,314 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information, Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property and Equipment, net [Abstract] | ||
Total property and equipment | $ 25 | $ 25 |
Less accumulated depreciation | (19) | (15) |
Property and equipment, net | 6 | 10 |
Depreciation expense | 4 | 4 |
Equipment [Member] | ||
Property and Equipment, net [Abstract] | ||
Total property and equipment | 20 | 20 |
Furniture [Member] | ||
Property and Equipment, net [Abstract] | ||
Total property and equipment | $ 5 | $ 5 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information, Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses [Abstract] | ||
Income taxes | $ 315 | $ 0 |
Payroll | 782 | 488 |
Professional services | 208 | 84 |
R&D services and supplies | 212 | 1,081 |
Other | 167 | 80 |
Total | $ 1,684 | $ 1,733 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information, Short-Term Loan (Details) | 12 Months Ended | ||
Dec. 31, 2022 USD ($) Intallment | Dec. 31, 2021 USD ($) | Nov. 30, 2021 USD ($) | |
Short-Term Loan [Abstract] | |||
Short-term loan | $ 0 | $ 538,000 | $ 600,000 |
Number of installments | Intallment | 6 | ||
Annual interest rate | 5.50% | ||
Interest expense | $ 9,000 | 2,000 | |
Short-term Loan [Member] | |||
Short-Term Loan [Abstract] | |||
Payment on short term loan | $ 108,000 |
Related Party Transactions (Det
Related Party Transactions (Details) | 12 Months Ended | |||
Apr. 08, 2022 USD ($) shares | Dec. 31, 2022 USD ($) Director shares | Dec. 31, 2021 USD ($) | Dec. 01, 2022 USD ($) | |
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Number of directors signed waiver agreements | Director | 6 | |||
Consulting fee payable in cash | $ | $ 25,000 | |||
Director [Member] | ||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Consulting fee payable in cash | $ | $ 10,000 | |||
Number of stock option granted (in shares) | shares | 50,000 | |||
Vesting period | 36 months | |||
Consulting expenses | $ | $ 105,000 | $ 0 | ||
Consulting expenses unpaid | $ | $ 25,000 | |||
Director [Member] | Vesting on March 31, 2023 [Member] | ||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Vesting percentage | 25% | |||
Pre-Merger Financing [Member] | ||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Number of directors | Director | 5 | |||
Amount invested in pre-merger financing | $ | $ 300,000 | |||
Number of converted initial shares received by directors (in shares) | shares | 17,729 | |||
Number of converted additional shares (in shares) | shares | 53,189 | |||
Pre-Merger Financing [Member] | Rexahn [Member] | ||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Number of directors | Director | 1 | |||
Pre-Merger Financing [Member] | Series A Warrants [Member] | ||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Number of converted additional shares (in shares) | shares | 80,366 | |||
Pre-Merger Financing [Member] | Series B Warrants [Member] | ||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||
Number of converted additional shares (in shares) | shares | 9,444 |
Stock-based Compensation, Stock
Stock-based Compensation, Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation | $ 1,807 | $ 1,914 |
General and Administrative [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation | 1,060 | 1,116 |
Research and Development [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation | $ 747 | $ 798 |
Stock-based Compensation, Sto_2
Stock-based Compensation, Stock Option Plan Activity (Details) - USD ($) | 12 Months Ended | ||||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 22, 2021 | Nov. 30, 2020 | Dec. 31, 2019 | ||
Ocuphire Stock Options [Abstract] | |||||||
Stock based compensation | $ 1,807,000 | $ 1,914,000 | |||||
Inducement Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 325,258 | ||||||
2020 Equity Incentive Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 1,000,000 | ||||||
Percentage of common stock shares outstanding | 5% | ||||||
2020 Equity Incentive Plan [Member] | Maximum [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 70,325 | ||||||
Period of shares reserved under plan | 10 years | ||||||
2018 Equity Incentive Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 0 | 1,175,000 | |||||
Weighted Average Exercise Price [Abstract] | |||||||
Aggregate intrinsic value, outstanding | $ 59,000 | $ 345,000 | |||||
Weighted average fair value per share of options granted (in dollars per share) | $ 3.29 | $ 3.49 | |||||
2018 Equity Incentive Plan [Member] | Minimum [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Vesting period | 5 months | ||||||
2018 Equity Incentive Plan [Member] | Maximum [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Vesting period | 48 months | ||||||
Ocuphire Stock Options [Member] | 2018 Equity Incentive Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Stock based compensation | $ 1,700,000 | $ 1,800,000 | |||||
Number of Options [Roll Forward] | |||||||
Outstanding, beginning balance (in shares) | 2,096,836 | 1,784,198 | |||||
Granted (in shares) | 893,305 | 420,300 | |||||
Exercised (in shares) | (24,309) | (73,442) | |||||
Forfeited/Cancelled (in shares) | (29,788) | (34,220) | |||||
Outstanding, ending balance (in shares) | 2,936,044 | 2,096,836 | 1,784,198 | ||||
Vested and expected to vest (in shares) | 2,936,044 | ||||||
Vested and exercisable (in shares) | 1,723,792 | ||||||
Weighted Average Exercise Price [Abstract] | |||||||
Outstanding, beginning balance (in dollars per share) | $ 2.97 | $ 2.17 | |||||
Granted (in dollars per share) | 2.64 | 5.72 | |||||
Exercised (in dollars per share) | 1.09 | 0 | |||||
Forfeited/Cancelled (in dollars per share) | 6.21 | 0 | |||||
Outstanding, ending balance (in dollars per share) | 2.87 | $ 2.97 | $ 2.17 | ||||
Vested and expected to vest (in dollars per share) | 2.87 | ||||||
Vested and exercisable (in dollars per share) | $ 2.56 | ||||||
Weighted average remaining contractual term, outstanding | 7 years 9 months 25 days | 8 years 2 months 12 days | 8 years 10 months 13 days | ||||
Weighted average remaining contractual term, vested and expected to vest | 7 years 9 months 25 days | ||||||
Weighted average remaining contractual term, vested and exercisable | 7 years 25 days | ||||||
Aggregate intrinsic value, outstanding | [1] | $ 3,314,000 | $ 2,795,000 | $ 7,744,000 | |||
Aggregate intrinsic value, vested and expected to vest | [1] | 3,314,000 | |||||
Aggregate intrinsic value, vested and exercisable | [1] | $ 1,680,000 | |||||
Aggregate intrinsic value (in dollars per share) | $ 3.53 | $ 3.73 | |||||
Weighted average fair value per share of options granted (in dollars per share) | $ 2.06 | $ 4.36 | |||||
[1]The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of our common stock as of December 31, 2022 and 2021 of $3.53 and $3.73 per share, respectively. |
Stock-based Compensation, Weigh
Stock-based Compensation, Weighted Average Assumptions Used in Black-Scholes Option-pricing Model (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
2020 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||
Common stock available for future issuance (in shares) | 894,920 | |
2018 Equity Incentive Plan [Member] | ||
Weighted-average Assumptions Used in Black-Scholes Option-pricing Model [Abstract] | ||
Expected stock price volatility | 97.40% | 98.10% |
Expected life of options (years) | 5 years 9 months 18 days | 5 years 9 months 18 days |
Expected dividend yield | 0% | 0% |
Risk free interest rate | 2.30% | 0.90% |
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||
Stock options vested (in shares) | 488,621 | 468,301 |
Weighted average fair value per share of options vesting (in dollars per share) | $ 3.29 | $ 3.49 |
Stock options forfeited (in shares) | 29,788 | 34,220 |
Unrecognized stock-based compensation cost | $ 2.6 | |
Weighted average period to recognized stock-based compensation | 1 year 2 months 12 days | |
Inducement Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||
Common stock available for future issuance (in shares) | 894,920 |
Stock-based Compensation, Restr
Stock-based Compensation, Restricted Stock Awards Activity (Details) - USD ($) | 12 Months Ended | ||
Nov. 11, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Ocuphire Restricted Stock Awards [Abstract] | |||
Stock based compensation | $ 1,807,000 | $ 1,914,000 | |
Ocuphire Restricted Stock Awards [Member] | |||
Ocuphire Restricted Stock Awards [Abstract] | |||
Stock based compensation | $ 0 | $ 22,000 | |
Summary of RSA Activity [Abstract] | |||
Non-vested at beginning (in shares) | 0 | 40,000 | |
Granted (in shares) | 40,000 | 0 | 0 |
Vested (in shares) | (40,000) | ||
Non-vested at ending (in shares) | 0 |
Stock-based Compensation, Commo
Stock-based Compensation, Common Stock Issued for Services (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) Member shares | Dec. 31, 2021 USD ($) Member shares | |
Common Stock Issued for Services [Abstract] | ||
Granted stock for services performed (in shares) | shares | 74,396 | 21,414 |
Number of board members, stock granted for services | Member | 4 | 2 |
Share based compensation for services | $ | $ 154,000 | $ 108,000 |
Stock-based Compensation, Forme
Stock-based Compensation, Former Rexahn Options (Details) - Rexahn [Member] - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Former Options [Abstract] | ||
Number of shares outstanding (in shares) | 0 | 123 |
Number of options expired (in shares) | 82 |
Apexian Sublicense Agreement (D
Apexian Sublicense Agreement (Details) - Apexian Sublicense Agreement [Member] - Maximum [Member] $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Development and Regulatory Milestones [Member] | |
Sublicense Agreement [Abstract] | |
Milestone payments | $ 11 |
Sales Milestones [Member] | |
Sublicense Agreement [Abstract] | |
Milestone payments | $ 20 |
Stockholders' Equity, At-The-Ma
Stockholders' Equity, At-The-Market Program (Details) - USD ($) | 12 Months Ended | |||
Mar. 11, 2021 | Feb. 12, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
At-The-Market Program [Abstract] | ||||
Gross proceeds | $ 4,428,000 | $ 28,491,000 | ||
Issuance expenses | $ 131,000 | $ 1,511,000 | ||
2021 Shelf [Member] | Maximum [Member] | ||||
At-The-Market Program [Abstract] | ||||
Aggregate offering price | $ 125,000,000 | |||
ATM [Member] | ||||
At-The-Market Program [Abstract] | ||||
Shares sold (in shares) | 1,848,980 | 2,778,890 | ||
Gross proceeds | $ 4,400,000 | $ 13,500,000 | ||
Issuance expenses | $ 133,000 | $ 400,000 | ||
ATM [Member] | Maximum [Member] | ||||
At-The-Market Program [Abstract] | ||||
Aggregate offering price | $ 40,000,000 |
Stockholders' Equity, Registere
Stockholders' Equity, Registered Direct Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Jun. 08, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Registered Direct Offerings [Abstract] | |||
Gross proceeds | $ 4,428 | $ 28,491 | |
Issuance expenses | $ 131 | $ 1,511 | |
Registered Direct Offering [Member] | |||
Registered Direct Offerings [Abstract] | |||
Gross proceeds | $ 15,000 | ||
Registered Direct Offering [Member] | Common Stock [Member] | |||
Registered Direct Offerings [Abstract] | |||
Shares sold (in shares) | 3,076,923 | ||
Warrants issued (in shares) | 1,538,461 | ||
Offering price (in dollars per share) | $ 4.875 | ||
Issuance expenses | $ 1,100 | ||
Registered Direct Offering [Member] | Warrants [Member] | |||
Registered Direct Offerings [Abstract] | |||
Offering price (in dollars per share) | $ 0.5 | ||
Exercise price (in dollars per share) | $ 6.09 | ||
Expiration period | 5 years | ||
Warrants outstanding (in shares) | 1,538,461 | ||
Minimum percentage of beneficial ownership | 4.99% | ||
Maximum percentage of beneficial ownership limitation | 9.99% |
License and Collaboration Agr_3
License and Collaboration Agreements, Nyxol License Agreement (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Nov. 06, 2022 USD ($) | Nov. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) Performanceobligation | Dec. 31, 2021 USD ($) | |
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Beginning Balance | $ 0 | |||
Revenue recognized | 39,850 | $ 589 | ||
Ending Balance | 3,552 | 0 | ||
Nyxol License Agreement [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Non-refundable cash payment received | $ 35,000 | $ 35,000 | ||
Maximum amount of payments receivable for development, regulatory and commercial milestones | $ 130,000 | |||
First potential payments to be received | 10,000 | |||
Maximum percentage of tiered royalties receivable | 20% | |||
Number of distinct performance obligations | Performanceobligation | 2 | |||
Aggregate transaction price to be recognized | $ 40,200 | |||
Period of non-cancellation window agreement | 120 days | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Beginning Balance | $ 0 | |||
Revenue recognized | 39,800 | |||
Execution of Nyxol License Agreement and one-time non-refundable payment | $ (35,000) | (35,000) | ||
Ending Balance | 3,552 | $ 0 | ||
Nyxol License Agreement [Member] | License Transfer Fee [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Aggregate transaction price to be recognized | $ 35,000 | |||
Estimated standalone selling price for license agreement | 287,800 | |||
Transaction price allocation of ESSP obligations | 39,500 | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Revenue recognized | 39,519 | |||
Reclassification to accounts receivable related to costs billed under the Nyxol License Agreement | (1,298) | |||
Nyxol License Agreement [Member] | Research and Development Services [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Aggregate transaction price to be recognized | 5,200 | |||
Estimated standalone selling price for license agreement | 5,200 | |||
Transaction price allocation of ESSP obligations | $ 700 | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Revenue recognized | $ 331 |
License and Collaboration Agr_4
License and Collaboration Agreements, BioSense License and Assignment Agreement (Details) | 1 Months Ended | 12 Months Ended | ||
Mar. 10, 2020 USD ($) | Jul. 31, 2021 USD ($) shares | Dec. 31, 2022 USD ($) Milestone Country | Dec. 31, 2021 USD ($) | |
BioSense License and Assignments Agreement [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Non-refundable cash payment received | $ 1,650,000 | |||
Milestone payment achieved for performance obligation, recorded as collaboration revenue | $ 100,000 | |||
Milestone payments received | $ 0 | |||
Maximum amount of payments receivable for development, regulatory and commercial milestones | 84,500,000 | |||
BioSense License and Assignments Agreement [Member] | Rexahn [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Non-refundable cash payment received | $ 1,550,000 | |||
Processa License Agreement [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Non-refundable cash payment received | $ 200,000 | |||
Milestone payments received | $ 0 | |||
Upfront payment received in common shares (in shares) | shares | 44,689 | |||
Upfront payment received in common shares | $ 289,000 | |||
Period of restriction from selling common stock | 1 year | |||
Number of times sales milestone payments | Milestone | 1 | |||
Percentage of milestone payments eligible to receive on sub-license agreement | 32% | |||
Number of countries | Country | 1 | |||
Milestone period to administer drug clinical trial of licensed product on first patient | 3 years | |||
Milestone period to administer drug clinical trial of licensed product on first patient for second indication | 5 years | |||
Period of opportunity to cure breach of agreement | 120 days | |||
Period of prior written notice to be served for termination of agreements | 120 days |
Net income (loss) per share, Co
Net income (loss) per share, Computation of Diluted Net Income (Loss) Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Computation of weighted average common shares [Abstract] | ||
Basic common shares outstanding (in shares) | 19,931,080 | 14,852,745 |
Dilutive stock options (in shares) | 589,165 | 0 |
Dilutive warrants (in shares) | 76,967 | 0 |
Diluted common shares outstanding (in shares) | 20,597,212 | 14,852,745 |
Net income (loss) per share, An
Net income (loss) per share, Anti-dilutive Securities Excluded from Computation of Net Income (Loss) per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Series A, Series B and RDO Warrants [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 7,145,201 | 7,282,999 |
Stock Options [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 2,346,879 | 2,096,836 |
Restricted Stock Awards Including Pending Issuances of Stock for Services [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 0 | 6,970 |
Former Rexahn Warrants [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 60,713 | 66,538 |
Former Rexahn Options [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 0 | 82 |
Income Taxes, Reconciliation of
Income Taxes, Reconciliation of Statutory to Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Federal Income Tax Rate Reconciliation [Abstract] | ||
Income tax (benefit) provision at federal statutory rate | 21% | (21.00%) |
Valuation allowance | (21.40%) | 11.90% |
State income tax, net of federal benefit | 4.90% | (4.80%) |
Warrants | 0% | 15.30% |
Stock options | 0.40% | (0.10%) |
Research and development | (3.10%) | (1.10%) |
Other | (0.10%) | (0.20%) |
Effective tax rate | 1.70% | 0% |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Components of Income Tax Provision (Benefit) [Abstract] | ||
Income (loss) before income taxes | $ 18,203 | $ (56,693) |
Current: | ||
Federal | 279 | 0 |
State | 36 | 0 |
Total current tax provision (benefit) | 315 | 0 |
Deferred: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Total tax provision (benefit) | $ 315 | $ 0 |
Income Taxes, Deferred Tax Asse
Income Taxes, Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Tax Assets [Abstract] | ||
Federal and state operating loss carryforwards | $ 13,087 | $ 19,244 |
Acquired intangibles | 547 | 547 |
Deferral of research and development costs | 2,820 | 0 |
Organizational costs | 7 | 7 |
Other | 62 | 18 |
Stock-based compensation | 1,152 | 811 |
Research and development credit carryforward | 731 | 1,035 |
Subtotal | 18,406 | 21,662 |
Valuation allowance | (17,770) | (21,662) |
Total deferred tax assets, net of valuation allowance | 636 | 0 |
Deferred Tax Liabilities [Abstract] | ||
Deferred revenue | (636) | 0 |
Total deferred tax liabilities | (636) | 0 |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes, Operating Loss Ca
Income Taxes, Operating Loss Carryforwards (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred Tax Assets, Operating Loss Carryforwards, Components [Abstract] | ||
Federal net operating loss carryforward | $ 10,900 | $ 15,700 |
Federal research credit carryforwards | 700 | 1,000 |
State net operating loss carryforward | 2,200 | 3,600 |
State research credit carryforwards | 0 | 0 |
Federal operating loss carryforwards, tax effect | 4,800 | |
State operating loss carryforwards, tax effect | 1,400 | |
Utilized federal research credit carryforwards | 900 | |
Income Tax Uncertainties [Abstract] | ||
Uncertain tax positions | 0 | 0 |
Interest and penalty on income tax expense | 0 | 0 |
Deferred tax assets relating to net operating loss carryforwards [Abstract] | ||
Deferred tax assets relating to net operating loss carryforwards | 13,087 | $ 19,244 |
Rexahn stockholders [Member] | ||
Deferred tax assets relating to net operating loss carryforwards [Abstract] | ||
Deferred tax assets relating to net operating loss carryforwards | $ 10,300 |
Deferred Compensation Plan (Det
Deferred Compensation Plan (Details) - 401K Plan [Member] - USD ($) | 12 Months Ended | ||
Oct. 01, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred Compensation Plan [Abstract] | |||
Employer matching contribution, first match | 100% | ||
Deferred compensation matched by employer, first match | 3% | ||
Additional employer matching contribution | 50% | ||
Additional deferred compensation matched by employer | 2% | ||
Employer contribution | $ 76,000 | $ 15,000 |
Subsequent Events (Details)
Subsequent Events (Details) - 2020 Plan Evergreen Provision [Member] - shares | 12 Months Ended | |
Jan. 01, 2023 | Dec. 31, 2022 | |
Subsequent Events [Abstract] | ||
Percentage of common stock shares outstanding | 5% | |
Maximum [Member] | ||
Subsequent Events [Abstract] | ||
Period of shares reserved under plan | 10 years | |
Subsequent Event [Member] | ||
Subsequent Events [Abstract] | ||
Number of shares added (in shares) | 1,043,066 |