Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 05, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
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 | 957-9024 | ||
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 | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 89,224,159 | ||
Entity Common Stock, Shares Outstanding | 24,813,370 | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Detroit, Michigan |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 50,501 | $ 42,634 |
Accounts receivable | 926 | 1,298 |
Contract assets and unbilled receivables (Note 9) | 1,407 | 3,552 |
Prepaids and other current assets | 1,099 | 1,453 |
Short-term investments | 15 | 49 |
Total current assets | 53,948 | 48,986 |
Property and equipment, net | 0 | 6 |
Total assets | 53,948 | 48,992 |
Current liabilities: | ||
Accounts payable | 2,153 | 1,069 |
Accrued expenses | 1,815 | 1,684 |
Derivative liability | 74 | 0 |
Total current liabilities | 4,042 | 2,753 |
Total liabilities | 4,042 | 2,753 |
Commitments and contingencies (Note 3 and Note 7) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of December 31, 2023 and 2022; no shares issued and outstanding at December 31, 2023 and 2022. | 0 | 0 |
Common stock, par value $0.0001; 75,000,000 shares authorized as of December 31, 2023 and 2022; 23,977,491 and 20,861,315 shares issued and outstanding at December 31, 2023 and 2022, respectively. | 2 | 2 |
Additional paid-in capital | 131,370 | 117,717 |
Accumulated deficit | (81,466) | (71,480) |
Total stockholders' equity | 49,906 | 46,239 |
Total liabilities and stockholders' equity | $ 53,948 | $ 48,992 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
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) | 23,977,491 | 20,861,315 |
Common stock, shares, outstanding (in shares) | 23,977,491 | 20,861,315 |
Statements of Comprehensive (Lo
Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statements of Comprehensive (Loss) Income [Abstract] | ||
License and collaborations revenue | $ 19,049 | $ 39,850 |
Operating expenses: | ||
General and administrative | 11,959 | 7,269 |
Research and development | 17,653 | 14,355 |
Total operating expenses | 29,612 | 21,624 |
(Loss) income from operations | (10,563) | 18,226 |
Financing costs (Note 8) | (1,328) | 0 |
Interest expense (Note 4) | 0 | (9) |
Fair value change in derivative liabilities | 80 | 0 |
Other income (expense), net | 1,837 | (14) |
(Loss) income before income taxes | (9,974) | 18,203 |
Provision for income taxes | (12) | (315) |
Net (loss) income | (9,986) | 17,888 |
Other comprehensive (loss) income, net of tax | 0 | 0 |
Comprehensive (loss) income | $ (9,986) | $ 17,888 |
Net (loss) income per share (Note 10): | ||
Basic (in dollars per share) | $ (0.46) | $ 0.9 |
Diluted (in dollars per share) | $ (0.46) | $ 0.87 |
Number of shares used in per share calculations: | ||
Basic (in shares) | 21,589,821 | 19,931,080 |
Diluted (in shares) | 21,589,821 | 20,597,212 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
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 and purchase agreement | $ 0 | 4,428 | 0 | 4,428 |
Issuance of common stock in connection with the at-the-market program and purchase agreement (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 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with the at-the-market program and purchase agreement | $ 0 | 10,249 | 0 | 10,249 |
Issuance of common stock in connection with the at-the-market program and purchase agreement (in shares) | 2,964,238 | |||
Issuance costs | $ 0 | (136) | 0 | (136) |
Exercise of Series B warrants | $ 0 | 0 | 0 | 0 |
Exercise of Series B warrants (in shares) | 17,869 | |||
Stock-based compensation | $ 0 | 3,510 | 0 | 3,510 |
Stock-based compensation (in shares) | 106,600 | |||
Exercise of stock options | $ 0 | 30 | 0 | 30 |
Exercise of stock options (in shares) | 27,469 | |||
Net and comprehensive income (loss) | $ 0 | 0 | (9,986) | (9,986) |
Balance at Dec. 31, 2023 | $ 2 | $ 131,370 | $ (81,466) | $ 49,906 |
Balance (in shares) at Dec. 31, 2023 | 23,977,491 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities | ||
Net (loss) income | $ (9,986) | $ 17,888 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Stock-based compensation | 3,510 | 1,807 |
Depreciation | 6 | 4 |
Fair value change in derivative liabilities | (80) | 0 |
Financing costs | 1,328 | 0 |
Unrealized loss from short-term investments | 34 | 170 |
Change in assets and liabilities: | ||
Accounts receivable | 372 | (1,298) |
Contract assets and unbilled receivables | 2,145 | (3,552) |
Prepaid expenses and other assets | 354 | (139) |
Accounts payable | 1,082 | (515) |
Accrued expenses | 123 | (51) |
Net cash (used in) provided by operating activities | (1,112) | 14,314 |
Investing activities | ||
Transaction costs in connection with asset acquisition | 0 | 0 |
Net cash used in investing activities | 0 | 0 |
Financing activities | ||
Proceeds from issuance of common stock | 9,227 | 4,428 |
Issuance costs attributed to common stock | (278) | (131) |
Payments made on short-term loan principal | 0 | (538) |
Exercise of stock options and Series B warrants | 30 | 27 |
Net cash provided by financing activities | 8,979 | 3,786 |
Net increase in cash and cash equivalents | 7,867 | 18,100 |
Cash and cash equivalents at beginning of period | 42,634 | 24,534 |
Cash and cash equivalents at end of period | 50,501 | 42,634 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 344 | 0 |
Cash paid for interest | 0 | 9 |
Supplemental non-cash financing transactions: | ||
Non-cash issuance of common stock in connection with equity purchase agreement | 1,022 | 0 |
Value of derivative established in connection with the equity purchase agreement | 154 | 0 |
Unpaid issuance costs | $ 10 | $ 2 |
Company Description and Summary
Company Description and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
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 biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders. The Company’s lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1α and NF-kB. Inhibiting Ref-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet administered once or twice per day in development for the treatment of diabetic retinopathy (“DR”). A Phase 2 study in subjects with DR or diabetic macular edema was completed and results were reported in January 2023. An End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (the “FDA”) was held in October 2023 at which the Company obtained agreement on the registration endpoint supporting the advancement of APX3330 into future clinical trials. Ocuphire submitted a Special Protocol Assessment (“SPA”) to the FDA in February 2024 to seek agreement on the clinical trial protocol and statistical The Company has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique mechanism of action of this family of Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration, geographic atrophy, and non-ophthalmic diseases. In November 2022, the Company entered into a license and collaboration agreement (the “Viatris License Agreement”) with FamyGen Life Sciences, Inc. (“Famy”) (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 refractive product candidate Phentolamine Ophthalmic Solution 0.75%, formerly known as Nyxol (“PS”). PS is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI in September 2023. The VEGA-2 Phase 3 study in presbyopia achieved its primary endpoint. PS is currently in Phase 3 clinical trials for presbyopia (age-related blurry near vision). On December 5, 2023, the Company received FDA Agreement Under Special Protocol Assessment for LYNX-2, a Phase 3 Trial of PS for the treatment of decreased Visual Acuity under dim (mesopic) light conditions following keratorefractive surgery. Reverse Merger with Rexahn On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”) and 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 merged 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 (“Nasdaq”) to “OCUP”. Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting standards generally accepted in the United States of America (“GAAP”). The Company does not have any subsidiaries or other entities that require consolidation for financial statement reporting purposes. Liquidity The accompanying 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 development and conducting clinical trials. As of December 31, 2023, the Company had $50.5 million in cash and cash equivalents. The Company believes its current available cash and cash equivalents will be sufficient to fund the Company’s planned expenditures and meet its obligations for at least twelve months from the date of issuance of these financial statements. 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 outcome of these actions to generate the liquidity ultimately required. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the 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 or such person functioning in such role. 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 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. Management follows approved policies established by its Board of Directors to reduce credit risk associated with the Company’s cash deposit and investment accounts. Pursuant to these policies, the Company limits its exposure through the kind, quality and concentration of its investments. The Company’s cash and cash equivalents are held or managed by two financial institutions in the United States. As of December 31, 2023, the Company had cash equivalents of $50.2 million that were not eligible for coverage by Federal Deposit Insurance Corporation (“FDIC”). These balances are invested in funds whose assets consist almost entirely of securities issued by the U.S. Treasury or guaranteed by the U.S. government. Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and records them on a settlement date basis. The Company’s short-term 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 income (expense), net on the statements of comprehensive (loss) income. 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, 2023. 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 9 – 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 Assets and Unbilled Receivables The Company recognizes contract assets and unbilled receivables when goods or services are transferred to the customer before the customer pays or before reimbursement for payment is billed or due, excluding any amounts presented as an account receivable. The Company recorded contract assets and unbilled receivables – Accounts Receivable and Allowances for Credit Losses The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. In estimating the allowance for credit losses, the Company considers, among other factors, the estimate of credit losses over the remaining expected life of the asset, primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future. 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. General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include insurance coverage for directors and officers and other property and liability exposures, legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, other services provided by business consultants and legal settlements. Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including compensation, benefits and stock-based compensation costs for research and development employees and costs for consultants, costs associated with nonclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses. Research and development expenses include costs that are reimbursed under the Viatris License Agreement (See Note 9 – Financing costs Financing costs consist of issuance costs attributed to an equity line financing facility with Lincoln Park (See Note 8 – Stockholders’ Equity). Interest Expense Interest expenses were attributed to interest on principal related to a short-term loan during the period it was outstanding. The short-term loan was fully repaid in May 2022. Other Income (Expense), net Other income (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 oc cur. In addition, this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former Rexahn shareholders. 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 Derivative Liability The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separation from the underlying agreement under ASC 815 – Derivatives and Hedging 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 in which there is little or no market data available, which requires management to develop its own assumptions in pricing the asset or liability. As of December 31, 2023 and 2022, the fair values of cash and cash equivalents, accounts receivable, contract assets and unbilled receivables, prepaid and other current assets, accounts payable, and accrued expenses approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the short-term investments, while outstanding, were based on observable Level 1 inputs in the form of quoted market prices from a major stock exchange. The fair value of the derivative liability associated with the equity line financing facility (See Note 8 – Stockholders’ Equity) was based on cash flow models discounted at current implied market rates representing expected returns by market participants for similar instruments and are based on Level 3 inputs The fair value of the warrant liabilities, while outstanding, were based on a Black-Scholes option model using Level 3 inputs. There were no transfers between fair value hierarchy levels during the years ended December 31, 2023 and 2022 . The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of December 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 15 $ 15 $ — $ — Total assets at fair value $ 15 $ 15 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 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 $ — $ — The following table provides a roll-forward of short-term investments and derivative liabilities measured at fair value on a recurring basis using observable Level 1 and Level 3 inputs, as applicable, for the years ended December 31, 2023 and 2022 (in thousands): 2023 2022 Short-term investments Balance as of beginning of period $ 49 $ 219 Unrealized loss (34 ) (170 ) Balance as of end of period $ 15 $ 49 2023 2022 Derivative liabilities Balance as of beginning of period $ — $ — Purchase agreement execution 154 — Unrealized gain (80 ) — Balance as of end of period $ 74 $ — Rexahn Warrants The fair value of the warrant liabilities associated with the Rexahn warrants was de minimis during the periods presented. The last of the Rexahn warrants classified as liabilities expired in April 2023 unexercised. See Note 2 – Merger for additional background . There were no financial instruments measured on a non-recurring basis for any of the periods presented. 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 earnings per share computation. The amendments in this ASU are effective for public business entities that meet the definition of an 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 adopted this ASU on January 1, 2023 and the adoption did not have a material impact on its financial statements. In November 2023, the FASB issued ASU 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which enhances reportable segment disclosure requirements, primarily through disclosures of significant segment expenses. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The guidance must be applied retrospectively to all prior periods presented. The Company is currently evaluating the impact of adoption of this guidance on its financial statements. In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which enhances income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This guidance also includes certain other amendments to improve the effectiveness of income tax disclosures. This ASU is effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years and should be applied on a prospective basis, with retrospective application permitted. The Company is currently evaluating the impact of adoption of this guidance on its financial statements. |
Merger
Merger | 12 Months Ended |
Dec. 31, 2023 | |
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 or 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, 2023, 58,597 of the Rexahn warrants remained outstanding with an exercise price of $38.40 per share with an average remaining contractual life of 0.1 years and were accounted for and classified as equity. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 3. 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 7 — Apexian Sublicense Agreement). As of December 31, 2023, there was sufficient uncertainty with regard to any future cash milestone payments under the sublicense agreement that 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 headquarters. The HQ Lease qualified for the short-term lease exception under ASC 842, Leases 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, 2023 | |
Supplemental Balance Sheet Information [Abstract] | |
Supplemental Balance Sheet Information | 4. Supplemental Balance Sheet Information Prepaid and Other Current Assets Prepaid and other current assets consist of the following (in thousands): December 31, 2023 2022 Prepaids $ 997 $ 1,373 Other 102 80 Total prepaids and other current assets $ 1,099 $ 1,453 Property and Equipment, net Property and equipment held for use by category are presented in the following table (in thousands): December 31, 2023 2022 Equipment $ 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (25 ) (19 ) Property and equipment, net $ — $ 6 Depreciation expense was $6,000 and 4,000 during the years ended December 31, 2023 and 2022, respectively. Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, 2023 2022 Income taxes $ — $ 315 Payroll 753 782 Professional services 591 208 R&D services and supplies 400 212 Other 71 167 Total $ 1,815 $ 1,684 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 was recognized in connection with the Loan during the year ended December 31, 2022. The final payment on the Loan was made in May 2022. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions On April 8, 2022, Ocuphire entered into a consulting agreement for medical advisory services with Jay Pepose, 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, Dr. Pepose received a stock option grant for 50,000 options, of which 25% vested 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 $300,000 and $105,000 during the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 and 2022, $25,000 and $25,000 of the related consulting expenses were unpaid, respectively. On April 19, 2023, Ocuphire appointed Richard Rodgers, a director of the Company, as interim President and Chief Executive Officer. In connection with his appointment, Ocuphire and Mr. Rodgers entered into a letter agreement concerning Mr. Rodgers’s services (the “Letter Agreement”). The Letter Agreement provided that Mr. Rodgers (i) was to receive a $40,000 monthly salary, and (ii) is eligible for a potential prorated bonus at the discretion of Ocuphire’s Board of Directors, at the end of his term as interim President and Chief Executive Officer. Mr. Rodgers also received 50,000 restricted stock units under the Company’s 2020 Equity Incentive Plan which will vest 12 months following the grant date. The Company incurred related expenses of $255,000 during the year ended December 31, 2023. As of December 31, 2023, $100,000 of the related expenses were unpaid related to a prorated bonus. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Stock-based Compensation [Abstract] | |
Stock-based Compensation | 6. 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 (loss) income for the periods indicated below (in thousands): December 31, 2023 2022 General and administrative $ 2,435 $ 1,060 Research and development 1,075 747 Total stock-based compensation $ 3,510 $ 1,807 Inducement Plan On February 22, 2021, the Company adopted the Ocuphire Pharma, Inc. 2021 Inducement Plan (the “Inducement Plan”) which was amended on November 1, 2023, pursuant to which the Company reserved 2,325,258 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 Stock Options During the years ended December 31, 2023 and 2022, 1,768,116 and 893,305 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 $2.5 million and $1.7 million in stock-based compensation expense related to stock options during the years ended December 31, 2023 and 2022, respectively. Stock-based compensation expense during the year ended December 31, 2023 included a one-time charge of $0.4 million attributed to the modification of the Company’s former Chief Executive Officer’s stock options with respect to their exercisability provisions During the years ended December 31, 2023 and 2022, 27,469 and 24,309 stock options were exercised, respectively, with an intrinsic value of $70,000 and $59,000, 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, 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 Granted 1,768,116 $ 3.20 Exercised (27,469 ) $ 1.09 Forfeited/Cancelled (266,433 ) $ 3.66 Outstanding at December 31, 2023 4,410,258 $ 2.98 7.81 $ 2,385 Vested and expected to vest at December 31, 2023 4,410,258 $ 2.98 7.81 $ 2,385 Vested and exercisable at December 31, 2023 2,519,673 $ 2.77 6.72 $ 607 (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, 2023 and 2022 of $3.01 and $3.53 per share, respectively. The weighted average fair value per share of options granted during the years ended December 31, 2023 and 2022 was $2.53 and $2.06, respectively. The Company measures the fair value of stock options with service-based vesting criteria to employees, directors and consultants 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, 2023 and 2022: 2023 2022 Expected stock price volatility 96.0 % 97.4 % Expected life of options (years) 6.1 5.8 Expected dividend yield 0 % 0 % Risk free interest rate 4.2 % 2.3 % During the years ended December 31, 2023 and 2022, 834,818 and 488,621 stock options vested, respectively. The weighted average fair value per share of options vesting during the years ended December 31, 2023 and 2022 was $2.41 and $3.29, respectively. During the years ended December 31, 2023 and 2022, 266,433 and 29,788 stock options were forfeited, respectively. Restricted Stock Units During the year ended December 31, 2023, the Company granted an aggregate of 936,156 restricted stock units (“RSUs”), respectively, to certain officers and employees under the 2020 Plan. The weighted average grant date per unit fair value of the RSUs granted during the year ended December 31, 2023 was $3.37. The vesting period of the RSUs range from a six month to four year period with vesting tranches on a quarterly, semi-annual and annual basis, subject to the recipient’s continued service on such dates. There were no RSUs granted during the year ended December 31, 2022. During the year ended December 31, 2023, 33,614 RSUs vested and 100,842 RSUs were forfeited, attributed solely to the departure of the Company’s former Chief Executive Officer. The total expense for the year ended December 31, 2023 related to the RSUs was $0.7 million A summary of RSU activity is as follows for the year ended December 31, 2023: Number of Shares Non-vested at December 31, 2022 — Granted 936,156 Forfeited (100,842 ) Vested (33,614 ) Non-vested at December 31, 2023 801,700 Common Stock Issued for Services The Company granted common stock for services in the amount of 72,986 and 74,396 shares of common stock during the years ended December 31, 2023 and 2022, respectively, with a weighted grant date fair value of $3.77 and $2.04 per share, respectively, to 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 $275,000 and $154,000 during the years ended December 31, 2023 and 2022, respectively General Unrecognized stock-based compensation cost was $6.4 million as of December 31, 2023. The unrecognized stock-based compensation cost is expected to be recognized over a weighted average period of 1.8 years. As of December 31, 2023, 1,528,003 shares in the aggregate were available for future issuance under the 2020 Plan and Inducement Plan . |
Apexian Sublicense Agreement
Apexian Sublicense Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Apexian Sublicense Agreement [Abstract] | |
Apexian Sublicense Agreement | 7. Apexian Sublicense Agreement On January 21, 2020, the Company entered into a sublicense agreement (as amended on June 4, 2020, the “Apexian 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 tablet therapeutic to treat diabetic retinopathy initially, and potentially later to treat diabetic macular edema, geographic atrophy and age-related macular degeneration. In connection with the Apexian Sublicense Agreement, the Company issued a total of 891,422 shares of its common stock to Apexian and to certain affiliates of Apexian in calendar year 2020. As a result of the common stock issued pursuant to the Apexian Sublicense Agreement, Apexian is considered by Ocuphire to be a related party The Company also agreed to make one-time milestone payments under the Apexian 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 several sales milestones. These milestone payments include (i) payments for specified developmental and regulatory milestones (including completion of the first Phase 2 trial 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 Apexian Sublicense Agreement. If it is not terminated pursuant to its terms, the Apexian 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, 2023. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders' Equity Lincoln Park Purchase Agreement On August 10, 2023, the Company entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) for an equity line financing (the “Purchase Agreement”). The Purchase Agreement provides that, subject to the terms and conditions set forth therein, the Company has the sole right, but not the obligation, to direct Lincoln Park to purchase up to $50 million of shares of the Company’s common stock from time to time over the 30-month term of the Purchase Agreement. Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which the Company agreed to register the resale of the shares of the Company’s common stock that have been and may be issued to Lincoln Park under the Purchase Agreement pursuant to a registration statement. Upon the execution of the Purchase Agreement, the Company issued 246,792 shares of the Company’s common stock to Lincoln Park with a fair value of $1.0 million as consideration for its commitment to purchase shares of the Company’s common stock under the Purchase Agreement which was recorded as a component of financing costs in the accompanying statements of comprehensive (loss) income during the year ended December 31, 2023. Lincoln Park has agreed not to cause or engage in any manner whatsoever in any direct or indirect short selling or hedging of the Company’s common stock. In addition to the commitment shares referenced above, a total of 1,300,000 shares of the Company’s common stock were sold under the Purchase Agreement for net proceeds through December 31, 2023 in the amount of $4.5 million. Lastly, the Company incurred issuance costs of $152,000, consisting of investor expense reimbursement and legal costs, during the year ended December 31, 2023 which were recorded as a component of financing costs in the accompanying statements of comprehensive (loss) income during the year ended December 31, 2023. No shares of the Company’s common stock were sold under the Purchase Agreement prior to the third quarter of 2023. Under the Purchase Agreement on any business day selected by the Company, the Company may direct Lincoln Park to purchase up to 50,000 shares of its common stock on such business day (or the purchase date) (a “Regular Purchase”), provided that the closing sale price of the Company’s common stock on Nasdaq on the applicable purchase date is not below $0.25 and subject to other adjustments. A Regular Purchase may be increased to up to (i) 60,000 shares if the closing sale price of the Company’s common stock on Nasdaq is not below $5.00 on the applicable purchase date and (ii) 70,000 shares if the closing sale price of the Company’s common stock on Nasdaq is not below $7.50 on the applicable purchase date. The Company may direct Lincoln Park to purchase shares in Regular Purchases as often as every business day. The purchase price per share for each such Regular Purchase will be equal to the lesser of: • the lowest sale price for the Company’s common stock on Nasdaq on the purchase date of such shares; and • the average of the three (3) lowest closing sale prices for the Company’s common stock on Nasdaq during the ten (10) consecutive business days prior to the purchase date of such shares. In addition, the Company may also direct Lincoln Park, on any business day on which the Company has submitted a Regular Purchase notice for the maximum amount allowed for such Regular Purchase, to purchase an additional amount of the Company’s common stock (an “Accelerated Purchase”) of up to the lesser of: • three (3) times the number of shares purchased pursuant to such Regular Purchase; and • 30% of the aggregate shares of the Company’s common stock traded on Nasdaq during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed (the “Accelerated Purchase Measurement Period”). The purchase price per share for each such Accelerated Purchase will be equal to 96.5% of the lower of: • the closing sale price of the Company’s common stock on Nasdaq on the applicable Accelerated Purchase date; and • the volume-weighted average price of the Company’s common stock on Nasdaq during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date. The Company may also direct Lincoln Park, on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been delivered to Lincoln Park in accordance with the Purchase Agreement, to purchase an additional amount of the Company’s common stock (an “Additional Accelerated Purchase”) as described in the Purchase Agreement. The pricing and settlement provisions in the Purchase Agreement result in the recognition of a derivative liability accounted for on a fair value basis under the provisions of ASC 815 - Derivatives and Hedging . A Monte Carlo simulation model was used to estimate future stock pricing and purchase activity to determine the fair value of the derivative liability as of the August 10, 2023 commencement date and again as of December 31, 2023. As of August 10, 2023 and December 31, 2023, the inputs used to determine fair value of the derivative liability included the Company’s Nasdaq closing stock price of $4.14 and $3.01 per share, respectively, a stock volatility rate of 82.5% and 77.5%, respectively, an expected term of 2.5 years and 2.1 years, respectively, and a risk-free interest rate of 4.6% and 4.2%, respectively. Lastly, the fair value of the derivative liability took into account future purchase decisions based on economic considerations and relevant stock issuance rules/limitations. The fair value change in the derivative liability was recorded in the fair value change in derivative liabilities line item in the accompanying statements of comprehensive (loss) income during the year ended December 31, 2023. 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 “2021 ATM”). During the years ended December 31, 2023 and 2022, 1,417,446 and shares of common stock were sold under the ATM for aggregate gross proceeds in the amount of $4.7 million and $4.4 million, respectively, before deducting issuance expenses, including the placement agent’s fees, legal and accounting expenses, in the amount of $136,000 and $133,000, respectively. See Note 13 Subsequent Events. 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, 2023, 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%. 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. 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, 2023. The Series A Warrants were accounted for and classified as equity on the accompanying balance sheets. Series B Warrants The Series B Warrants had an exercise price of $0.0001, were exercisable upon issuance and would have expired on the day following the later to occur of (i) the Reservation Date (as defined therein) or (ii) the date on which the investor’s Series B Warrants would have been exercised in full (without giving effect to any limitation on exercise contained therein). None of the Series B Warrants were outstanding as of December 31, 2023. During the year ended December 31, 2023 and 2022, 17,869 and 60,832 warrants were exercised for shares of common stock, respectively. The Series B Warrants were accounted for and classified as equity on the accompanying balance sheets while outstanding |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2023 | |
License and Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 9. License and Collaboration Agreements Viatris License Agreement On November 6, 2022, the Company entered into the Viatris License Agreement, pursuant to which it granted Viatris (as successor to Famy) an exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize (i) PS, for treating (a) reversal of mydriasis, (b) night vision disturbances or dim light vision, and (c) presbyopia, and (ii) PS and low dose pilocarpine for treating presbyopia (together, the “PS 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 PS Products outside of the Viatris Territory. Under the terms of the Viatris License Agreement, the Company in partnership with Viatris, will develop the PS Products in the United States. Viatris will reimburse the Company for budgeted costs related to the development of the PS Products through FDA approval. Viatris will be responsible for developing the PS Products in countries and jurisdictions in the Viatris Territory outside of the United States. The parties established a joint steering committee, which oversees and makes decisions regarding the development of the PS Products. The committee is composed of an equal number of representatives of Viatris and Ocuphire. Viatris will commercialize the PS Products in the Viatris Territory for each indication that receives regulatory approval. Pursuant to the Viatris 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 PS Products in the Viatris Territory. In addition, with respect to the PS Products, 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 milestone payment of $10 million to be made following approval by the FDA of PS, for reversal of mydriasis which occurred during the third quarter of 2023. The Company will also receive tiered royalties, starting at low double-digit royalties up to low 20% royalties, based on the aggregate annual net sales of all PS 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 PS Product in a country of the Viatris Territory until December 31, 2040. Either party may terminate the Viatris 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 Viatris or its affiliates commences an action challenging the validity, enforceability or scope of any of Ocuphire’s patents that are exclusively licensed under the Viatris License Agreement. Additionally, if Viatris determines not to pursue development or commercialization of a PS Product in a country or jurisdiction in the Viatris Territory, Viatris may terminate the license with respect to such PS 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 Viatris License Agreement. The Viatris 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 at the effective date: (1) the license to its intellectual property (“license transfer”) and (2) research and development services. The aggregate transaction price associated with the Viatris License Agreement, as adjusted for variable consideration subsequent to December 31, 2022, was $40.0 million which comprised the initial license transfer fee of $35.0 million and the $5.0 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 performance obligations for research and development services through the non-cancellation period were fully met by the Company as of the first quarter of 2023. The SSP for the license transfer and for the research and development services was determined to be $ 287.8 million and $5.0 million, respectively. The SSP for the license tran sfer was determined based on a discounted royalty cash flow approach, taking into consideration assumptions, including 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 Viatris which occurred during the fourth quarter of 2022. The Company determined that revenue related to the research and development services constrained to the 120-day non-cancellation period was to be recognized over time as the services are rendered based on an estimated percentage of completion input model. Recognition of Revenue On September 25, 2023, the Company met the $10 million milestone payment requirements attributed to the FDA’s approval of PS, for reversal of mydriasis and included the milestone in the revenue recognized during the year ended December 31, 2023. The $10 million milestone payment was previously constrained by the Company with regard to its inclusion in the initial aggregate transaction price associated with the Viatris License Agreement. During the year ended December 31, 2022, the licenses transferred to Viatris 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. Revenue recognized under the Viatris License Agreement during the years ended December 31, 2023 and 2022 was $19.0 million and $ 39.8 Regulatory Milestones under the Viatris License Agreement The Company has evaluated the regulatory milestones that may be received in connection with the Viatris License Agreement. There is uncertainty that the events to obtain the remaining regulatory milestones (aside from the approval by the FDA of PS, for reversal of mydriasis) will be achieved given the nature of clinical development and the stage of the development of the PS Products. These 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 Viatris 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. Each of the remaining regulatory and sales milestone performance obligations (aside from the $10 million milestone payment related to the FDA’s approval of PS, for reversal of mydriasis) and the royalty payments were fully constrained as of December 31, 2023 and no revenue was recognized. A reconciliation of the closing balance of the contract assets and unbilled receivables associated with the Viatris License Agreement is as follows as of December 31, 2023 and 2022 (in thousands): 2023 2022 Contract Assets and Unbilled Receivables Balance as of beginning of period $ 3,552 $ — License transfer — (35,000 ) Revenue recognized 19,049 39,850 Reclassification to accounts receivable related to costs billed under the Viatris License Agreement (21,194 ) (1,298 ) Balance as of end of period $ 1,407 $ 3,552 The remaining amounts in contract assets and unbilled receivables as of December 31, 2023 attributed to the research and development services are expected to be settled during the first quarter of 2024. BioSense License and Assignment Agreement On March 10, 2020, prior to the 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 and the remaining $100,000 during calendar year 2021. 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, 2023, 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. Processa will make future 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 percentage 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, 2023, 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. Future payments received under the Processa License Agreement will be subject to the CVR Agreement described in Note 2 – Merger. |
Net (loss) income per share
Net (loss) income per share | 12 Months Ended |
Dec. 31, 2023 | |
Net (loss) income per share [Abstract] | |
Net (loss) income per share | 10. Net (loss) income per share Basic (loss) income per share of common stock is computed by dividing net (loss) income 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 loss or earnings 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 RSUs, while outstanding, are considered common stock equivalents for this purpose. Diluted earnings is computed utilizing the treasury method for the warrants, stock options and RSUs. Incremental common stock equivalents that were antidilutive were excluded in calculating diluted income per share. For the year ended December 31, 2023, 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 (loss) income per share: 2023 2022 Denominator (weighted average shares) Basic common shares outstanding 21,589,821 19,931,080 Dilutive stock options — 589,165 Dilutive warrants — 76,967 Diluted common shares outstanding 21,589,821 20,597,212 The following potential common shares were not considered in the computation of diluted net (loss) income 2023 2022 Series A, Series B and RDO warrants 7,204,299 7,145,201 Stock options 4,410,258 2,346,879 RSUs 801,700 — Former Rexahn warrants 58,597 60,713 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | 11. Income Taxes The effective tax rate for the years ended December 31, 2023 and 2022 was 0.1 percent and 1.7 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 (loss) income is as follows for the years ended December 31, 2023 and 2022: 2023 2022 Income tax (benefit) provision at federal statutory rate (21.0 )% 21.0 % Valuation allowance 23.8 (21.4 ) State income tax, net of federal benefit (4.9 ) 4.9 Financing contracts 3.2 — Stock options 1.0 0.4 Research and development (3.9 ) (3.1 ) Other 1.9 (0.1 ) Effective tax rate 0.1 % 1.7 % The components of income tax provision (benefit) consisted of the following for the years ended December 31, 2023 and 2022 (in thousands): 2023 2022 (Loss) income before income taxes: $ (9,974 ) $ 18,203 Current: Federal $ 2 $ 279 State 10 36 Total current tax provision (benefit) 12 $ 315 Deferred: Federal — — State — — Total tax provision (benefit ) $ 12 $ 315 Significant components of the Company’s deferred tax assets and liabilities are summarized in the tables below as of December 31, 2023 and 2022 (in thousands): 2023 2022 Deferred tax assets: Federal and state operating loss carryforwards $ 12,780 $ 13,087 Acquired intangibles 547 547 Deferral of research and development costs 3,794 2,820 Organizational costs 6 7 Other 72 62 Stock-based compensation 1,835 1,152 Research and development credit carryforward 1,107 731 Subtotal 20,141 18,406 Valuation allowance (20,141 ) (17,770 ) 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, 2023 and 2022, the Company had gross deferred tax assets of approximately $20.1 million and $18.4 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 of $20.1 million and $17.8 million as of December 31, 2023 and 2022, respectively. U.S. net deferred tax assets will continue to require a valuation allowance until the Company can demonstrate their realizability through sustained profitability or another source of income. As of December 31, 2023 and 2022, the tax effect of the Company’s federal net operating loss carryforwards was approximately $ 10.6 million and $10.9 million, respectively. The Company had federal research credit carryforwards as of December 31, 2023 and 2022 of approximately $ 1.1 million and $0.7 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, 2023 and 2022, the Company had state net operating loss carryforwards with a tax effect of approximately $ 2.1 million and $2.2 million, respectively. The Company did not have any state research credit carryforwards as of December 31, 2023 and 2022. The state net operating loss carryforwards will begin to expire in 2028. During the year ended December 31, 2023, the Company utilized federal and state net operating tax carryforwards with a tax effect in the amount of $0.2 million and $0.1 million, respectively, to offset taxable income. In addition, the Company also utilized its federal research credit carryforwards in the amount of $26,000 to partially offset its tax liability for the year ended December 31, 2023. During 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. In accordance with ASC 740 , Income Taxes , specifically related to uncertain tax positions, a Company is required to use a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. 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, 2023 | |
Deferred Compensation Plan [Abstract] | |
Deferred Compensation Plan | 12. 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, 2023 and 2022, the Company contributed $99,000 and $76,000 to the 401K Plan, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events 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, 2024, 1,198,875 shares were added to the 2020 Plan as a result of the evergreen provision. On February 12, 2024, the Company issued a total of 435,000 stock options and 215,000 restricted stock units under the Inducement Plan to its newly appointed Chief Financial and Chief Scientific and Development Officers. The option awards have an exercise price of $2.66 per share. The options vest over a period of four years, with 25% vesting one year after the date of grant and the remaining 75% vesting in equal quarterly installments thereafter, and the RSUs vest in four equal installments on the first, second, third and fourth anniversary of the grant date of February 12, 2024 On January 10, 2024, the Company filed a Form S-3 shelf registration under the Securities Act which was declared effective by the SEC on January 23, 2024 under which the Company may offer and sell, from time to time in its sole discretion, securities having an aggregate offering price up to $175 million. |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Company Description and Summa_2
Company Description and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
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 biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders. The Company’s lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1α and NF-kB. Inhibiting Ref-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet administered once or twice per day in development for the treatment of diabetic retinopathy (“DR”). A Phase 2 study in subjects with DR or diabetic macular edema was completed and results were reported in January 2023. An End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (the “FDA”) was held in October 2023 at which the Company obtained agreement on the registration endpoint supporting the advancement of APX3330 into future clinical trials. Ocuphire submitted a Special Protocol Assessment (“SPA”) to the FDA in February 2024 to seek agreement on the clinical trial protocol and statistical The Company has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique mechanism of action of this family of Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration, geographic atrophy, and non-ophthalmic diseases. In November 2022, the Company entered into a license and collaboration agreement (the “Viatris License Agreement”) with FamyGen Life Sciences, Inc. (“Famy”) (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 refractive product candidate Phentolamine Ophthalmic Solution 0.75%, formerly known as Nyxol (“PS”). PS is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI in September 2023. The VEGA-2 Phase 3 study in presbyopia achieved its primary endpoint. PS is currently in Phase 3 clinical trials for presbyopia (age-related blurry near vision). On December 5, 2023, the Company received FDA Agreement Under Special Protocol Assessment for LYNX-2, a Phase 3 Trial of PS for the treatment of decreased Visual Acuity under dim (mesopic) light conditions following keratorefractive surgery. |
Reverse Merger with Rexahn | Reverse Merger with Rexahn On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”) and 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 merged 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 (“Nasdaq”) to “OCUP”. |
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”). The Company does not have any subsidiaries or other entities that require consolidation for financial statement reporting purposes. |
Liquidity | Liquidity The accompanying 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 development and conducting clinical trials. As of December 31, 2023, the Company had $50.5 million in cash and cash equivalents. The Company believes its current available cash and cash equivalents will be sufficient to fund the Company’s planned expenditures and meet its obligations for at least twelve months from the date of issuance of these financial statements. 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 outcome of these actions to generate the liquidity ultimately required. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the 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 or such person functioning in such role. 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 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. Management follows approved policies established by its Board of Directors to reduce credit risk associated with the Company’s cash deposit and investment accounts. Pursuant to these policies, the Company limits its exposure through the kind, quality and concentration of its investments. The Company’s cash and cash equivalents are held or managed by two financial institutions in the United States. As of December 31, 2023, the Company had cash equivalents of $50.2 million that were not eligible for coverage by Federal Deposit Insurance Corporation (“FDIC”). These balances are invested in funds whose assets consist almost entirely of securities issued by the U.S. Treasury or guaranteed by the U.S. government. |
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 records them on a settlement date basis. The Company’s short-term 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 income (expense), net on the statements of comprehensive (loss) income. 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, 2023. |
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 9 – 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 Assets and Unbilled Receivables | Contract Assets and Unbilled Receivables The Company recognizes contract assets and unbilled receivables when goods or services are transferred to the customer before the customer pays or before reimbursement for payment is billed or due, excluding any amounts presented as an account receivable. The Company recorded contract assets and unbilled receivables – |
Accounts Receivable and Allowances for Credit Losses | Accounts Receivable and Allowances for Credit Losses The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. In estimating the allowance for credit losses, the Company considers, among other factors, the estimate of credit losses over the remaining expected life of the asset, primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future. 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. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include insurance coverage for directors and officers and other property and liability exposures, legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, other services provided by business consultants and legal settlements. |
Research and Development | Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including compensation, benefits and stock-based compensation costs for research and development employees and costs for consultants, costs associated with nonclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses. Research and development expenses include costs that are reimbursed under the Viatris License Agreement (See Note 9 – |
Financing costs | Financing costs Financing costs consist of issuance costs attributed to an equity line financing facility with Lincoln Park (See Note 8 – Stockholders’ Equity). |
Interest Expense | Interest Expense Interest expenses were attributed to interest on principal related to a short-term loan during the period it was outstanding. The short-term loan was fully repaid in May 2022. |
Other Income (Expense), net | Other Income (Expense), net Other income (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 oc cur. In addition, this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former Rexahn shareholders. |
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 |
Derivative Liability | Derivative Liability The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separation from the underlying agreement under ASC 815 – Derivatives and Hedging |
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 in which there is little or no market data available, which requires management to develop its own assumptions in pricing the asset or liability. As of December 31, 2023 and 2022, the fair values of cash and cash equivalents, accounts receivable, contract assets and unbilled receivables, prepaid and other current assets, accounts payable, and accrued expenses approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the short-term investments, while outstanding, were based on observable Level 1 inputs in the form of quoted market prices from a major stock exchange. The fair value of the derivative liability associated with the equity line financing facility (See Note 8 – Stockholders’ Equity) was based on cash flow models discounted at current implied market rates representing expected returns by market participants for similar instruments and are based on Level 3 inputs The fair value of the warrant liabilities, while outstanding, were based on a Black-Scholes option model using Level 3 inputs. There were no transfers between fair value hierarchy levels during the years ended December 31, 2023 and 2022 . The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of December 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 15 $ 15 $ — $ — Total assets at fair value $ 15 $ 15 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 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 $ — $ — The following table provides a roll-forward of short-term investments and derivative liabilities measured at fair value on a recurring basis using observable Level 1 and Level 3 inputs, as applicable, for the years ended December 31, 2023 and 2022 (in thousands): 2023 2022 Short-term investments Balance as of beginning of period $ 49 $ 219 Unrealized loss (34 ) (170 ) Balance as of end of period $ 15 $ 49 2023 2022 Derivative liabilities Balance as of beginning of period $ — $ — Purchase agreement execution 154 — Unrealized gain (80 ) — Balance as of end of period $ 74 $ — |
Rexahn Warrants | Rexahn Warrants The fair value of the warrant liabilities associated with the Rexahn warrants was de minimis during the periods presented. The last of the Rexahn warrants classified as liabilities expired in April 2023 unexercised. See Note 2 – Merger for additional background . There were no financial instruments measured on a non-recurring basis for any of the periods presented. |
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 earnings per share computation. The amendments in this ASU are effective for public business entities that meet the definition of an 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 adopted this ASU on January 1, 2023 and the adoption did not have a material impact on its financial statements. In November 2023, the FASB issued ASU 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which enhances reportable segment disclosure requirements, primarily through disclosures of significant segment expenses. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The guidance must be applied retrospectively to all prior periods presented. The Company is currently evaluating the impact of adoption of this guidance on its financial statements. In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which enhances income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This guidance also includes certain other amendments to improve the effectiveness of income tax disclosures. This ASU is effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years and should be applied on a prospective basis, with retrospective application permitted. The Company is currently evaluating the impact of adoption of this guidance on its financial statements. |
Company Description and Summa_3
Company Description and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 15 $ 15 $ — $ — Total assets at fair value $ 15 $ 15 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 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 $ — $ — |
Fair Value, Investments and Derivative Liabilities Measured on a Recurring Basis | The following table provides a roll-forward of short-term investments and derivative liabilities measured at fair value on a recurring basis using observable Level 1 and Level 3 inputs, as applicable, for the years ended December 31, 2023 and 2022 (in thousands): 2023 2022 Short-term investments Balance as of beginning of period $ 49 $ 219 Unrealized loss (34 ) (170 ) Balance as of end of period $ 15 $ 49 2023 2022 Derivative liabilities Balance as of beginning of period $ — $ — Purchase agreement execution 154 — Unrealized gain (80 ) — Balance as of end of period $ 74 $ — |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Supplemental Balance Sheet Information [Abstract] | |
Prepaid and Other Current Assets | Prepaid and other current assets consist of the following (in thousands): December 31, 2023 2022 Prepaids $ 997 $ 1,373 Other 102 80 Total prepaids and other current assets $ 1,099 $ 1,453 |
Property and Equipment, Net | Property and equipment held for use by category are presented in the following table (in thousands): December 31, 2023 2022 Equipment $ 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (25 ) (19 ) Property and equipment, net $ — $ 6 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2023 2022 Income taxes $ — $ 315 Payroll 753 782 Professional services 591 208 R&D services and supplies 400 212 Other 71 167 Total $ 1,815 $ 1,684 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 (loss) income for the periods indicated below (in thousands): December 31, 2023 2022 General and administrative $ 2,435 $ 1,060 Research and development 1,075 747 Total stock-based compensation $ 3,510 $ 1,807 |
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, 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 Granted 1,768,116 $ 3.20 Exercised (27,469 ) $ 1.09 Forfeited/Cancelled (266,433 ) $ 3.66 Outstanding at December 31, 2023 4,410,258 $ 2.98 7.81 $ 2,385 Vested and expected to vest at December 31, 2023 4,410,258 $ 2.98 7.81 $ 2,385 Vested and exercisable at December 31, 2023 2,519,673 $ 2.77 6.72 $ 607 (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, 2023 and 2022 of $3.01 and $3.53 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, 2023 and 2022: 2023 2022 Expected stock price volatility 96.0 % 97.4 % Expected life of options (years) 6.1 5.8 Expected dividend yield 0 % 0 % Risk free interest rate 4.2 % 2.3 % |
Restricted Stock Units Activity | A summary of RSU activity is as follows for the year ended December 31, 2023: Number of Shares Non-vested at December 31, 2022 — Granted 936,156 Forfeited (100,842 ) Vested (33,614 ) Non-vested at December 31, 2023 801,700 |
License and Collaboration Agr_2
License and Collaboration Agreements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
License and Collaboration Agreements [Abstract] | |
Reconciliation of Contract Asset assets and Unbilled Receivables | A reconciliation of the closing balance of the contract assets and unbilled receivables associated with the Viatris License Agreement is as follows as of December 31, 2023 and 2022 (in thousands): 2023 2022 Contract Assets and Unbilled Receivables Balance as of beginning of period $ 3,552 $ — License transfer — (35,000 ) Revenue recognized 19,049 39,850 Reclassification to accounts receivable related to costs billed under the Viatris License Agreement (21,194 ) (1,298 ) Balance as of end of period $ 1,407 $ 3,552 |
Net (loss) income per share (Ta
Net (loss) income per share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Net (loss) income 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 (loss) income per share: 2023 2022 Denominator (weighted average shares) Basic common shares outstanding 21,589,821 19,931,080 Dilutive stock options — 589,165 Dilutive warrants — 76,967 Diluted common shares outstanding 21,589,821 20,597,212 |
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 (loss) income 2023 2022 Series A, Series B and RDO warrants 7,204,299 7,145,201 Stock options 4,410,258 2,346,879 RSUs 801,700 — Former Rexahn warrants 58,597 60,713 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 (loss) income is as follows for the years ended December 31, 2023 and 2022: 2023 2022 Income tax (benefit) provision at federal statutory rate (21.0 )% 21.0 % Valuation allowance 23.8 (21.4 ) State income tax, net of federal benefit (4.9 ) 4.9 Financing contracts 3.2 — Stock options 1.0 0.4 Research and development (3.9 ) (3.1 ) Other 1.9 (0.1 ) Effective tax rate 0.1 % 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, 2023 and 2022 (in thousands): 2023 2022 (Loss) income before income taxes: $ (9,974 ) $ 18,203 Current: Federal $ 2 $ 279 State 10 36 Total current tax provision (benefit) 12 $ 315 Deferred: Federal — — State — — Total tax provision (benefit ) $ 12 $ 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, 2023 and 2022 (in thousands): 2023 2022 Deferred tax assets: Federal and state operating loss carryforwards $ 12,780 $ 13,087 Acquired intangibles 547 547 Deferral of research and development costs 3,794 2,820 Organizational costs 6 7 Other 72 62 Stock-based compensation 1,835 1,152 Research and development credit carryforward 1,107 731 Subtotal 20,141 18,406 Valuation allowance (20,141 ) (17,770 ) 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, Liquidity (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Liquidity [Abstract] | ||
Cash and cash equivalents | $ 50,501 | $ 42,634 |
Company Description and Summa_5
Company Description and Summary of Significant Accounting Policies, Segment Information (Details) | 12 Months Ended |
Dec. 31, 2023 Segment | |
Segment Information [Abstract] | |
Number of operating segments | 1 |
Company Description and Summa_6
Company Description and Summary of Significant Accounting Policies, Concentration of Credit Risk (Details) $ in Millions | Dec. 31, 2023 USD ($) |
Concentration of Credit Risk [Abstract] | |
Cash equivalents not eligible for coverage | $ 50.2 |
Company Description and Summa_7
Company Description and Summary of Significant Accounting Policies, Short-term Investments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Other than Temporary Impairment Losses, Investments [Abstract] | |
Impairments on investments | $ 0 |
Company Description and Summa_8
Company Description and Summary of Significant Accounting Policies, Contract Assets and Unbilled Receivables and Accounts Receivable and Allowances for Doubtful Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Contract Assets and Unbilled Receivables and Accounts Receivable and Allowances for Doubtful Accounts [Abstract] | ||
Allowance for credit loss | $ 0 | $ 0 |
Bad debt expense | $ 0 |
Company Description and Summa_9
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, 2023 | Dec. 31, 2022 | |
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 | 15 | 49 |
Liabilities [Abstract] | ||
Total liabilities at fair value | 74 | |
Recurring Basis [Member] | Derivative Liability [Member] | ||
Liabilities [Abstract] | ||
Total liabilities at fair value | 74 | |
Recurring Basis [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 15 | 49 |
Recurring Basis [Member] | Level 1 [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 15 | 49 |
Liabilities [Abstract] | ||
Total liabilities at fair value | 0 | |
Recurring Basis [Member] | Level 1 [Member] | Derivative Liability [Member] | ||
Liabilities [Abstract] | ||
Total liabilities at fair value | 0 | |
Recurring Basis [Member] | Level 1 [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 15 | 49 |
Recurring Basis [Member] | Level 2 [Member] | ||
Assets [Abstract] | ||
Assets at fair value | 0 | 0 |
Liabilities [Abstract] | ||
Total liabilities at fair value | 0 | |
Recurring Basis [Member] | Level 2 [Member] | Derivative Liability [Member] | ||
Liabilities [Abstract] | ||
Total liabilities at fair value | 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 |
Liabilities [Abstract] | ||
Total liabilities at fair value | 74 | |
Recurring Basis [Member] | Level 3 [Member] | Derivative Liability [Member] | ||
Liabilities [Abstract] | ||
Total liabilities at fair value | 74 | |
Recurring Basis [Member] | Level 3 [Member] | Short- term investments [Member] | ||
Assets [Abstract] | ||
Assets at fair value | $ 0 | $ 0 |
Company Description and Summ_10
Company Description and Summary of Significant Accounting Policies, Equity Investments Measured at Fair Value (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity Investments [Abstract] | ||
Unrealized loss | $ (34) | $ (170) |
Derivative Liability [Abstract] | ||
Balance as of beginning of period | 0 | |
Balance as of end of period | 74 | 0 |
Recurring Basis [Member] | Level 1 [Member] | Short- term investments [Member] | ||
Equity Investments [Abstract] | ||
Balance as of beginning of period | 49 | 219 |
Unrealized loss | (34) | (170) |
Balance as of end of period | 15 | 49 |
Recurring Basis [Member] | Level 3 [Member] | ||
Derivative Liability [Abstract] | ||
Balance as of beginning of period | 0 | 0 |
Purchase agreement execution | 154 | 0 |
Unrealized gain | (80) | 0 |
Balance as of end of period | $ 74 | $ 0 |
Company Description and Summ_11
Company Description and Summary of Significant Accounting Policies, Rexahn Warrants (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Nonrecurring Basis [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Financial instruments liabilities at fair value | $ 0 | $ 0 |
Merger, Contingent Value Rights
Merger, Contingent Value Rights Agreement (Details) | 12 Months Ended | |||
Dec. 31, 2023 USD ($) Milestone | Sep. 30, 2021 Milestone | Jun. 30, 2021 Milestone | Nov. 05, 2020 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 | |||
Number of potential milestones | 0 | 0 | ||
Payments for CVR | $ | $ 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, 2023 | Nov. 05, 2020 | |
Former Rexahn Warrants and Stock Options [Abstract] | ||
Number of warrants outstanding (in shares) | 58,597 | 231,433 |
Exercise price (in dollars per share) | $ 38.4 | |
Average remaining contractual life | 1 month 6 days |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Facility Lease [Abstract] | ||
Monthly base rent | $ 3,000 | |
Rent expense | 36,000 | $ 39,000 |
Expected rent payment for the year end 2024 | $ 36,000 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information, Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid and Other Current Assets [Abstract] | ||
Prepaids | $ 997 | $ 1,373 |
Other | 102 | 80 |
Total prepaids and other assets | $ 1,099 | $ 1,453 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information, Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property and Equipment, net [Abstract] | ||
Total property and equipment | $ 25 | $ 25 |
Less accumulated depreciation | (25) | (19) |
Property and equipment, net | 0 | 6 |
Depreciation expense | 6 | 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, 2023 | Dec. 31, 2022 |
Accrued Expenses [Abstract] | ||
Income taxes | $ 0 | $ 315 |
Payroll | 753 | 782 |
Professional services | 591 | 208 |
R&D services and supplies | 400 | 212 |
Other | 71 | 167 |
Total | $ 1,815 | $ 1,684 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information, Short-Term Loan (Details) | 12 Months Ended | |||
Dec. 31, 2023 USD ($) Intallment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 30, 2021 USD ($) | |
Short-Term Loan [Abstract] | ||||
Short-term loan | $ 600,000 | |||
Number of installments | Intallment | 6 | |||
Annual interest rate | 5.50% | |||
Interest expense | $ 0 | $ 9,000 | ||
Short-term Loan [Member] | ||||
Short-Term Loan [Abstract] | ||||
Payment on short term loan | $ 108,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | ||||
Apr. 19, 2023 | Apr. 08, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 01, 2022 | |
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Restricted stock units (in shares) | 72,986 | 74,396 | |||
Letter Agreement [Member] | |||||
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Monthly salary | $ 40,000 | ||||
Letter Agreement [Member] | 2020 Equity Incentive Plan [Member] | |||||
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Vesting period | 12 months | ||||
Restricted stock units (in shares) | 50,000 | ||||
Jay Pepose [Member] | |||||
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Consulting fee payable in cash | $ 10,000 | $ 25,000 | |||
Number of stock option granted (in shares) | 50,000 | ||||
Vesting period | 36 months | ||||
Consulting expenses | $ 300,000 | $ 105,000 | |||
Consulting expenses unpaid | $ 25,000 | $ 25,000 | |||
Jay Pepose [Member] | Vested on March 31, 2023 [Member] | |||||
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Vesting percentage | 25% | ||||
Richard Rodgers [Member] | |||||
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Consulting expenses | $ 255,000 | ||||
Consulting expenses unpaid | $ 100,000 |
Stock-based Compensation, Stock
Stock-based Compensation, Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-based Compensation Expense [Abstract] | ||
Stock-based compensation | $ 3,510 | $ 1,807 |
General and Administrative [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock-based compensation | 2,435 | 1,060 |
Research and Development [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock-based compensation | $ 1,075 | $ 747 |
Stock-based Compensation, Sto_2
Stock-based Compensation, Stock Option Plan Activity (Details) - USD ($) | 12 Months Ended | ||||||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 01, 2023 | Nov. 30, 2020 | Dec. 31, 2019 | ||
Stock Options [Abstract] | |||||||
Stock-based compensation | $ 3,510,000 | $ 1,807,000 | |||||
Inducement Plan [Member] | |||||||
Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 2,325,258 | ||||||
2020 Equity Incentive Plan [Member] | |||||||
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] | |||||||
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] | |||||||
Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 0 | 1,175,000 | |||||
Weighted Average Exercise Price [Abstract] | |||||||
Aggregate intrinsic value, outstanding | $ 70,000 | $ 59,000 | |||||
Weighted average fair value per share of options granted (in dollars per share) | $ 2.41 | $ 3.29 | |||||
2018 Equity Incentive Plan [Member] | Former Chief Executive Officer [Member] | |||||||
Stock Options [Abstract] | |||||||
Stock-based compensation | $ 400,000 | ||||||
2018 Equity Incentive Plan [Member] | Minimum [Member] | |||||||
Stock Options [Abstract] | |||||||
Vesting period | 5 months | ||||||
2018 Equity Incentive Plan [Member] | Maximum [Member] | |||||||
Stock Options [Abstract] | |||||||
Vesting period | 48 months | ||||||
Stock Options [Member] | 2018 Equity Incentive Plan [Member] | |||||||
Stock Options [Abstract] | |||||||
Stock-based compensation | $ 2,500,000 | $ 1,700,000 | |||||
Number of Options [Roll Forward] | |||||||
Outstanding, beginning balance (in shares) | 2,936,044 | 2,096,836 | |||||
Granted (in shares) | 1,768,116 | 893,305 | |||||
Exercised (in shares) | (27,469) | (24,309) | |||||
Forfeited/Cancelled (in shares) | (266,433) | (29,788) | |||||
Outstanding, ending balance (in shares) | 4,410,258 | 2,936,044 | 2,096,836 | ||||
Vested and expected to vest (in shares) | 4,410,258 | ||||||
Vested and exercisable (in shares) | 2,519,673 | ||||||
Weighted Average Exercise Price [Abstract] | |||||||
Outstanding, beginning balance (in dollars per share) | $ 2.87 | $ 2.97 | |||||
Granted (in dollars per share) | 3.2 | 2.64 | |||||
Exercised (in dollars per share) | 1.09 | 1.09 | |||||
Forfeited/Cancelled (in dollars per share) | 3.66 | 6.21 | |||||
Outstanding, ending balance (in dollars per share) | 2.98 | $ 2.87 | $ 2.97 | ||||
Vested and expected to vest (in dollars per share) | 2.98 | ||||||
Vested and exercisable (in dollars per share) | $ 2.77 | ||||||
Weighted average remaining contractual term, outstanding | 7 years 9 months 21 days | 7 years 9 months 25 days | 8 years 2 months 12 days | ||||
Weighted average remaining contractual term, vested and expected to vest | 7 years 9 months 21 days | ||||||
Weighted average remaining contractual term, vested and exercisable | 6 years 8 months 19 days | ||||||
Aggregate intrinsic value, outstanding | [1] | $ 2,385,000 | $ 3,314,000 | $ 2,795,000 | |||
Aggregate intrinsic value, vested and expected to vest | [1] | 2,385,000 | |||||
Aggregate intrinsic value, vested and exercisable | [1] | $ 607,000 | |||||
Aggregate intrinsic value (in dollars per share) | $ 3.01 | $ 3.53 | |||||
Weighted average fair value per share of options granted (in dollars per share) | $ 2.53 | $ 2.06 | |||||
[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, 2023 and 2022 of $3.01 and $3.53 per share, respectively. |
Stock-based Compensation, Weigh
Stock-based Compensation, Weighted Average Assumptions Used in Black-Scholes Option-pricing Model (Details) - 2018 Equity Incentive Plan [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Weighted-average Assumptions Used in Black-Scholes Option-pricing Model [Abstract] | ||
Expected stock price volatility | 96% | 97.40% |
Expected life of options (years) | 6 years 1 month 6 days | 5 years 9 months 18 days |
Expected dividend yield | 0% | 0% |
Risk free interest rate | 4.20% | 2.30% |
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||
Stock options vested (in shares) | 834,818 | 488,621 |
Weighted average fair value per share of options vesting (in dollars per share) | $ 2.41 | $ 3.29 |
Stock options forfeited (in shares) | 266,433 | 29,788 |
Stock-based Compensation, Restr
Stock-based Compensation, Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restricted Stock Units [Abstract] | ||
Stock-based compensation | $ 3,510 | $ 1,807 |
Restricted Stock Units [Member] | ||
Restricted Stock Units [Abstract] | ||
Stock-based compensation | $ 700 | |
Summary of RSU Activity [Abstract] | ||
Non-vested at beginning (in shares) | 0 | |
Granted (in shares) | 936,156 | |
Forfeited (in shares) | (100,842) | |
Vested (in shares) | (33,614) | |
Non-vested at ending (in shares) | 801,700 | 0 |
Restricted Stock Units [Member] | Former Chief Executive Officer [Member] | ||
Summary of RSU Activity [Abstract] | ||
Forfeited (in shares) | (100,842) | |
Vested (in shares) | (33,614) | |
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | ||
Restricted Stock Units [Abstract] | ||
Weighted average grant date fair value of RSUs granted (in dollars per share) | $ 3.37 | |
Summary of RSU Activity [Abstract] | ||
Granted (in shares) | 936,156 | 0 |
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | Minimum [Member] | ||
Restricted Stock Units [Abstract] | ||
Vesting period | 6 months | |
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | Maximum [Member] | ||
Restricted Stock Units [Abstract] | ||
Vesting period | 4 years |
Stock-based Compensation, Commo
Stock-based Compensation, Common Stock Issued for Services (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Common Stock Issued for Services [Abstract] | ||
Granted stock for services performed (in shares) | 72,986 | 74,396 |
Weighted grant date fair value per share of services granted (in dollars per share) | $ 3.77 | $ 2.04 |
Share based compensation for services | $ 275,000 | $ 154,000 |
Stock-based Compensation, Gener
Stock-based Compensation, General (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) shares | |
General [Abstract] | |
Unrecognized stock-based compensation cost | $ | $ 6.4 |
Weighted average period to recognized stock-based compensation | 1 year 9 months 18 days |
2020 Plan Evergreen Provision [Member] | |
General [Abstract] | |
Common stock available for future issuance (in shares) | 1,528,003 |
2018 Equity Incentive Plan [Member] | |
General [Abstract] | |
Common stock available for future issuance (in shares) | 1,528,003 |
Apexian Sublicense Agreement (D
Apexian Sublicense Agreement (Details) - Apexian Sublicense Agreement [Member] - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2020 | |
Sublicense Agreement [Abstract] | ||
Common stock issued (in shares) | 891,422 | |
Development and Regulatory Milestones [Member] | Maximum [Member] | ||
Sublicense Agreement [Abstract] | ||
Milestone payments | $ 11 | |
Sales Milestones [Member] | Maximum [Member] | ||
Sublicense Agreement [Abstract] | ||
Milestone payments | $ 20 |
Stockholders' Equity, Lincoln P
Stockholders' Equity, Lincoln Park Purchase Agreement (Details) | 3 Months Ended | 12 Months Ended | ||
Aug. 10, 2023 USD ($) Time $ / shares shares | Sep. 30, 2023 shares | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | |
Lincoln Park Purchase Agreement [Abstract] | ||||
Net proceeds | $ 9,227,000 | $ 4,428,000 | ||
Issuance costs | $ 278,000 | $ 131,000 | ||
Lincoln Park [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Term of purchase agreement | 30 months | |||
Consideration shares of common stock (in shares) | shares | 246,792 | 0 | 1,300,000 | |
Common stock fair value | $ 1,000,000 | |||
Net proceeds | $ 4,500,000 | |||
Issuance costs | $ 152,000 | |||
Number of consecutive trading days | 10 days | |||
Number of time shares purchased | Time | 3 | |||
Percentage of common stock | 30% | |||
Percentage of accelerated purchase | 96.50% | |||
Lincoln Park [Member] | Closing Stock Price [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Measurement input | 4.14 | 3.01 | ||
Lincoln Park [Member] | Stock Volatility Rate [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Measurement input | 0.825 | 0.775 | ||
Lincoln Park [Member] | Expected Term [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Measurement input | 2.5 | 2.1 | ||
Lincoln Park [Member] | Risk Free Interest Rate [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Measurement input | 0.046 | 0.042 | ||
Lincoln Park [Member] | Maximum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Purchase of common stock | $ 50,000,000 | |||
Lincoln Park [Member] | Closing Sale Price, not Below $0.25 [Member] | Maximum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Purchase of common stock (in shares) | shares | 50,000 | |||
Lincoln Park [Member] | Closing Sale Price, not Below $0.25 [Member] | Minimum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Closing stock price (in dollars per share) | $ / shares | $ 0.25 | |||
Lincoln Park [Member] | Closing Sale Price, not Below $5.00 [Member] | Maximum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Purchase of common stock (in shares) | shares | 60,000 | |||
Lincoln Park [Member] | Closing Sale Price, not Below $5.00 [Member] | Minimum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Closing stock price (in dollars per share) | $ / shares | $ 5 | |||
Lincoln Park [Member] | Closing Sale Price, not Below $7.50 [Member] | Maximum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Purchase of common stock (in shares) | shares | 70,000 | |||
Lincoln Park [Member] | Closing Sale Price, not Below $7.50 [Member] | Minimum [Member] | ||||
Lincoln Park Purchase Agreement [Abstract] | ||||
Closing stock price (in dollars per share) | $ / shares | $ 7.5 |
Stockholders' Equity, At-The-Ma
Stockholders' Equity, At-The-Market Program (Details) - USD ($) | 12 Months Ended | |||
Mar. 11, 2021 | Feb. 12, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
At-The-Market Program [Abstract] | ||||
Gross proceeds | $ 9,227,000 | $ 4,428,000 | ||
Issuance expenses | $ 278,000 | $ 131,000 | ||
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) | 1,417,446 | 1,848,980 | ||
Gross proceeds | $ 4,700,000 | $ 4,400,000 | ||
Issuance expenses | $ 136,000 | $ 133,000 | ||
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, 2023 | Dec. 31, 2022 | |
Registered Direct Offerings [Abstract] | |||
Gross proceeds | $ 9,227 | $ 4,428 | |
Issuance expenses | $ 278 | $ 131 | |
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] | RDO Warrants [Member] | |||
Registered Direct Offerings [Abstract] | |||
Number of RDO warrants sold at offering price (per unit) | 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% |
Stockholders' Equity, Pre-Merge
Stockholders' Equity, Pre-Merger Financing, Series A & B Warrants (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Jun. 29, 2020 USD ($) Director | Dec. 31, 2023 $ / shares shares | Dec. 31, 2022 shares | Nov. 19, 2020 $ / shares shares | Nov. 05, 2020 shares | |
Rexahn [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Exercise price (in dollars per share) | $ / shares | $ 38.4 | ||||
Warrants outstanding (in shares) | 58,597 | 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) | 5,665,838 | ||||
Series B Warrants [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Exercise price (in dollars per share) | $ / shares | $ 0.0001 | ||||
Warrants outstanding (in shares) | 0 | ||||
Warrants exercised (in shares) | 17,869 | 60,832 |
License and Collaboration Agr_3
License and Collaboration Agreements, Viatris License Agreement (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Sep. 25, 2023 USD ($) | Nov. 06, 2022 USD ($) | Nov. 30, 2022 USD ($) | Dec. 31, 2023 USD ($) Performanceobligation | Dec. 31, 2022 USD ($) | |
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||
Revenue recognized | $ 19,049 | $ 39,850 | |||
Viatris License Agreement [Member] | |||||
Collaboration and License Agreement [Abstract] | |||||
Non-refundable cash payment received | $ 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 | $ 10,000 | $ 40,000 | |||
Period of non-cancellation window agreement | 120 days | ||||
Milestone payment included in revenue recognization | 10,000 | ||||
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||
Balance as of beginning of period | 3,552 | 0 | |||
Revenue recognized | 19,049 | 39,850 | |||
Balance as of end of period | 1,407 | 3,552 | |||
Viatris 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 | 39,300 | ||||
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||
Revenue recognized | 0 | (35,000) | |||
Reclassification to accounts receivable related to costs billed under the Viatris License Agreement | (21,194) | $ (1,298) | |||
Viatris License Agreement [Member] | Research and Development Services [Member] | |||||
Collaboration and License Agreement [Abstract] | |||||
Aggregate transaction price to be recognized | 5,000 | ||||
Estimated standalone selling price for license agreement | 5,000 | ||||
Transaction price allocation of ESSP obligations | $ 700 | ||||
Viatris License Agreement [Member] | Sales Milestones [Member] | |||||
Collaboration and License Agreement [Abstract] | |||||
Milestone payment requirements attributed to the FDA's approval | 10,000 | ||||
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||
Revenue recognized | $ 0 |
License and Collaboration Agr_4
License and Collaboration Agreements, BioSense License and Assignment Agreement (Details) | 12 Months Ended | ||
Mar. 10, 2020 USD ($) | Dec. 31, 2023 USD ($) 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] | |||
Milestone payments received | $ 0 | ||
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 (loss) income per share, Co
Net (loss) income per share, Computation of Diluted Net Income (Loss) Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Computation of weighted average common shares [Abstract] | ||
Basic common shares outstanding (in shares) | 21,589,821 | 19,931,080 |
Dilutive stock options (in shares) | 0 | 589,165 |
Dilutive warrants (in shares) | 0 | 76,967 |
Diluted common shares outstanding (in shares) | 21,589,821 | 20,597,212 |
Net (loss) income per share, An
Net (loss) income per share, Anti-dilutive Securities Excluded from Computation of Net Income (Loss) per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Series A, Series B and RDO Warrants [Member] | ||
Net Income (Loss) Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 7,204,299 | 7,145,201 |
Stock Options [Member] | ||
Net Income (Loss) Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 4,410,258 | 2,346,879 |
RSUs [Member] | ||
Net Income (Loss) Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 801,700 | 0 |
Former Rexahn Warrants [Member] | ||
Net Income (Loss) Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 58,597 | 60,713 |
Income Taxes, Reconciliation of
Income Taxes, Reconciliation of Statutory to Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Effective Federal Income Tax Rate Reconciliation [Abstract] | ||
Income tax (benefit) provision at federal statutory rate | (21.00%) | 21% |
Valuation allowance | 23.80% | (21.40%) |
State income tax, net of federal benefit | (4.90%) | 4.90% |
Financing contracts | 3.20% | 0% |
Stock options | 1% | 0.40% |
Research and development | (3.90%) | (3.10%) |
Other | 1.90% | (0.10%) |
Effective tax rate | 0.10% | 1.70% |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Components of Income Tax Provision (Benefit) [Abstract] | ||
(Loss) income before income taxes | $ (9,974) | $ 18,203 |
Current: | ||
Federal | 2 | 279 |
State | 10 | 36 |
Total current tax provision (benefit) | 12 | 315 |
Deferred: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Total tax provision (benefit) | $ 12 | $ 315 |
Income Taxes, Deferred Tax Asse
Income Taxes, Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Tax Assets [Abstract] | ||
Federal and state operating loss carryforwards | $ 12,780 | $ 13,087 |
Acquired intangibles | 547 | 547 |
Deferral of research and development costs | 3,794 | 2,820 |
Organizational costs | 6 | 7 |
Other | 72 | 62 |
Stock-based compensation | 1,835 | 1,152 |
Research and development credit carryforward | 1,107 | 731 |
Subtotal | 20,141 | 18,406 |
Valuation allowance | (20,141) | (17,770) |
Total deferred tax assets, net of valuation allowance | 0 | 636 |
Deferred Tax Liabilities [Abstract] | ||
Deferred revenue | 0 | (636) |
Total deferred tax liabilities | 0 | (636) |
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, 2023 | Dec. 31, 2022 | |
Deferred Tax Assets, Operating Loss Carryforwards, Components [Abstract] | ||
Federal net operating loss carryforward | $ 10,600 | $ 10,900 |
Federal research credit carryforwards | 1,100 | 700 |
State net operating loss carryforward | 2,100 | 2,200 |
State research credit carryforwards | 0 | 0 |
Federal operating loss carryforwards, tax effect | 200 | 4,800 |
State operating loss carryforwards, tax effect | 100 | 1,400 |
Utilized federal research credit carryforwards | 26 | 900 |
Income Tax Uncertainties [Abstract] | ||
Reserves or related accruals for 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 | 12,780 | $ 13,087 |
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, 2023 | Dec. 31, 2022 | |
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 | $ 99,000 | $ 76,000 |
Subsequent Events (Details)
Subsequent Events (Details) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Feb. 12, 2024 Intallment $ / shares shares | Jan. 10, 2024 USD ($) | Jan. 01, 2024 shares | Dec. 31, 2023 | |
2020 Plan Evergreen Provision [Member] | ||||
Subsequent Events [Abstract] | ||||
Percentage of common stock shares outstanding | 5% | |||
2020 Plan Evergreen Provision [Member] | Maximum [Member] | ||||
Subsequent Events [Abstract] | ||||
Period of shares reserved under plan | 10 years | |||
Subsequent Event [Member] | Maximum [Member] | ||||
Subsequent Events [Abstract] | ||||
Aggregate offering price | $ | $ 175 | |||
Subsequent Event [Member] | 2020 Plan Evergreen Provision [Member] | ||||
Subsequent Events [Abstract] | ||||
Number of shares added (in shares) | 1,198,875 | |||
Subsequent Event [Member] | Inducement Plan [Member] | Stock Options [Member] | ||||
Subsequent Events [Abstract] | ||||
Shares issued (in shares) | 435,000 | |||
Common stock exercise price of options (in dollars per share) | $ / shares | $ 2.66 | |||
Vesting period | 4 years | |||
Subsequent Event [Member] | Inducement Plan [Member] | Stock Options [Member] | Tranche One [Member] | ||||
Subsequent Events [Abstract] | ||||
Vesting percentage | 25% | |||
Subsequent Event [Member] | Inducement Plan [Member] | Stock Options [Member] | Tranche Two [Member] | ||||
Subsequent Events [Abstract] | ||||
Vesting percentage | 75% | |||
Subsequent Event [Member] | Inducement Plan [Member] | Restricted Stock Units [Member] | ||||
Subsequent Events [Abstract] | ||||
Shares issued (in shares) | 215,000 | |||
Number of equal annual installments for vesting | Intallment | 4 |