Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
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, $0.0001 par value per share | |
Trading Symbol | OCUP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 20,952,170 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 38,988 | $ 42,634 |
Accounts receivable (Note 9) | 2,834 | 1,298 |
Contract asset (Note 9) | 2,467 | 3,552 |
Prepaids and other current assets | 1,088 | 1,453 |
Short-term investments | 22 | 49 |
Total current assets | 45,399 | 48,986 |
Property and equipment, net | 5 | 6 |
Total assets | 45,404 | 48,992 |
Current liabilities: | ||
Accounts payable | 2,221 | 1,069 |
Accrued expenses | 1,933 | 1,684 |
Total current liabilities | 4,154 | 2,753 |
Warrant liabilities | 0 | 0 |
Total liabilities | 4,154 | 2,753 |
Commitments and contingencies (Note 3 and Note 8) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2023 and December 31, 2022; no shares issued and outstanding at March 31, 2023 and December 31, 2022. | 0 | 0 |
Common stock, par value $0.0001; 75,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 20,947,830 and 20,861,315 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively. | 2 | 2 |
Additional paid-in capital | 118,519 | 117,717 |
Accumulated deficit | (77,271) | (71,480) |
Total stockholders' equity | 41,250 | 46,239 |
Total liabilities and stockholders' equity | $ 45,404 | $ 48,992 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 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) | 20,947,830 | 20,861,315 |
Common stock, shares outstanding (in shares) | 20,947,830 | 20,861,315 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Condensed Statements of Comprehensive Loss [Abstract] | ||
License and collaborations revenue | $ 1,749 | $ 0 |
Operating expenses: | ||
General and administrative | 2,285 | 1,736 |
Research and development | 5,595 | 4,772 |
Total operating expenses | 7,880 | 6,508 |
Loss from operations | (6,131) | (6,508) |
Interest expense | 0 | (5) |
Fair value change in warrant liabilities | 0 | 0 |
Other income (expense), net | 340 | (82) |
Loss before income taxes | (5,791) | (6,595) |
Benefit (provision) for income taxes | 0 | 0 |
Net loss | (5,791) | (6,595) |
Other comprehensive loss, net of tax | 0 | 0 |
Comprehensive loss | $ (5,791) | $ (6,595) |
Net loss per share: | ||
Basic (Note 10) (in dollars per share) | $ (0.28) | $ (0.35) |
Diluted (Note 10) (in dollars per share) | $ (0.28) | $ (0.35) |
Number of shares used in per share calculations: | ||
Basic (in shares) | 20,939,607 | 18,888,471 |
Diluted (in shares) | 20,939,607 | 18,888,471 |
Condensed Statements of Changes
Condensed 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 | $ 0 | 1,208 | 0 | 1,208 |
Issuance of common stock in connection with the at-the-market program (in shares) | 336,544 | |||
Issuance costs | $ 0 | (35) | 0 | (35) |
Stock-based compensation | $ 0 | 445 | 0 | 445 |
Stock-based compensation (in shares) | 6,970 | |||
Exercise of stock options | $ 0 | 27 | 0 | 27 |
Exercise of stock options (in shares) | 24,309 | |||
Net and comprehensive loss | $ 0 | 0 | (6,595) | (6,595) |
Balance at Mar. 31, 2022 | $ 2 | 113,233 | (95,963) | 17,272 |
Balance (in shares) at Mar. 31, 2022 | 19,213,651 | |||
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 costs | $ 0 | (2) | 0 | (2) |
Stock-based compensation | $ 0 | 804 | 0 | 804 |
Stock-based compensation (in shares) | 68,646 | |||
Exercise of warrants | $ 0 | 0 | 0 | 0 |
Exercise of warrants (in shares) | 17,869 | |||
Net and comprehensive loss | $ 0 | 0 | (5,791) | (5,791) |
Balance at Mar. 31, 2023 | $ 2 | $ 118,519 | $ (77,271) | $ 41,250 |
Balance (in shares) at Mar. 31, 2023 | 20,947,830 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities | ||
Net loss | $ (5,791) | $ (6,595) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 804 | 445 |
Depreciation | 1 | 1 |
Fair value change in warrant liabilities | 0 | 0 |
Unrealized loss from short-term investments | 27 | 84 |
Change in assets and liabilities: | ||
Accounts receivable | (1,536) | 0 |
Contract asset | 1,085 | 0 |
Prepaid expenses and other assets | 365 | 219 |
Accounts payable | 1,152 | (5) |
Accrued and other liabilities | 247 | (319) |
Net cash used in operating activities | (3,646) | (6,170) |
Investing activities | ||
Net cash used in investing activities | 0 | 0 |
Financing activities | ||
Proceeds from issuance of common stock in connection with the at-the-market program | 0 | 1,208 |
Issuance costs | 0 | (30) |
Payments made in connection with short-term loan | 0 | (323) |
Exercise of Series B warrants | 0 | 0 |
Exercise of stock options | 0 | 27 |
Net cash provided by financing activities | 0 | 882 |
Net decrease in cash and cash equivalents | (3,646) | (5,288) |
Cash and cash equivalents at beginning of period | 42,634 | 24,534 |
Cash and cash equivalents at end of period | 38,988 | 19,246 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 0 | 0 |
Cash paid for interest | 0 | 5 |
Supplemental non-cash financing transactions: | ||
Unpaid issuance and deferred offering costs | $ 2 | $ 5 |
Company Description and Summary
Company Description and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 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 ophthalmic 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 twice-a-day oral tablet designed to target multiple pathways relevant to retinal and choroidal (the vascular layer of the eye) diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual blindness. The Company has also in-licensed APX2009 and APX2014, which are second-generation product candidates and analogs of APX3330. In November 2022, the Company entered into a license and collaboration agreement (the “Nyxol License Agreement”) with FamyGen Life Sciences, Inc. (acquired by Viatris, Inc. (“Viatris”) in January 2023) pursuant to which it granted Viatris an exclusive license to develop, manufacture, import, export and commercialize its refractive product candidate phentolamine ophthalmic solution 0.75% (Nyxol® Eye Drops or “Nyxol”). Nyxol is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. Nyxol can potentially be used across multiple indications such as treatment of pharmacologically-induced mydriasis (“RM”) (dilation of the pupil), presbyopia (age-related blurry near vision) and dim light or night vision disturbances (“DLD”) (halos, glares and starbursts) . Reverse Merger with Rexahn On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”), Razor Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rexahn (“Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization, as amended on June 29, 2020 (as amended, the “Merger Agreement”), pursuant to which, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub would merge with and into Ocuphire, with Ocuphire continuing as a wholly-owned subsidiary of Rexahn and the surviving corporation of the merger (the “Merger”). The Merger closed on November 5, 2020. Upon completion of the Merger, Rexahn changed its name to Ocuphire Pharma, Inc. and changed its ticker symbol on the Nasdaq Capital Market to “OCUP”. The Company’s headquarters is located in Farmington Hills, Michigan. Global Economic Conditions Generally, worldwide economic conditions remain uncertain, particularly due to the effects of the conflict between Russia and Ukraine, disruptions in the banking system and financial markets, lingering Additionally, the Company’s operating results could be materially impacted by changes in the overall macroeconomic environment and other economic factors. Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the conflict in Ukraine, disruptions in the banking system and financial markets, Basis of Presentation The accompanying condensed financial statements have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The December 31, 2022 condensed balance sheet was derived from audited financial statements, and may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2022. In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods. On December 31, 2021, the Company merged its wholly-owned subsidiary, OcuSub Inc, with and into the Company, with the Company remaining as the surviving entity. The merger of the Company’s wholly-owned subsidiary did not have a financial impact in the periods presented. Upon close of this merger, the Company did not have any remaining entities that required consolidation for financial statement reporting purposes. All significant intercompany accounts and transactions were eliminated in the preparation of the condensed financial statements prior to the December 31, 2021 merger with OcuSub Inc Liquidity The accompanying condensed 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 March 31, 2023, the Company had $39.0 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 12 months following May 15, 2023, which is the date that these condensed financial statements are being issued. In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the ultimate outcome of these actions to generate the liquidity ultimately required. Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from those estimates. Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development 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. The Company’s cash is held or managed by one financial institution in the United States. Amounts on deposit exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. In addition, the Company limits its exposure through the kind, quality and concentration of its investments. As of March 31, 2023, the Company had deposits that exceeded federally insured amounts by $38.7 million. Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and are recorded on a settlement date basis. The Company’s 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 condensed statements of comprehensive loss. The Company classifies investments available to fund current operations as current assets on its balance sheets. The Company did not recognize any impairments on its investments to date through March 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 : If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other obligations, such as research and development services, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. For research and development services that are distinct from a license transfer obligation, the Company determines whether the services are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from such services. Milestone payments : At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until such contingency occurs (such as receipt of those approvals). Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Contract Asset The Company recognizes a contract asset when goods or services are transferred to the customer before the customer pays or before payment is due, excluding any amounts presented as an accounts receivable. The Company recorded a contract asset in connection with a license and collaboration agreement in the amount of $2.5 million as of March 31, 2023. See Note 9- License and Collaboration Agreements. Accounts Receivable and Allowances for Doubtful Accounts The Company records a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable. In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable, its historical write-offs, the credit worthiness of each customer, and 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. The Company has not incurred any bad debt expense to date and no allowance for doubtful accounts has been recorded during the periods presented. General and Administrative Expenses General and administrative expenses (“G&A”) consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, settlement costs with third parties and other services provided by business consultants. Research and Development Research and development expenses (“R&D”) consist of costs incurred in performing research and development activities, including compensation for research and development employees and consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, fees paid to external service providers that conduct certain research and development, and an allocation of R&D related overhead expenses. R&D costs include costs that are reimbursed under the Nyxol License Agreement. Other Income (Expense), net Other income (expense), net reflected in this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former Rexahn shareholders. In addition, other 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 occur. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC 718”), Compensation — Stock Compensation. Accordingly, compensation costs related to equity instruments granted are recognized at the grant date fair value. The Company records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable provisions of ASC 718. Warrant Liabilities The Company assumed Rexahn warrants issued prior to the Merger. The Company accounts for these warrants as a liability while outstanding at fair value during periods when certain provisions preclude equity accounting treatment for these instruments. The change in fair value of the warrant liabilities while outstanding are recognized as a component of the fair value change in warrant liabilities line item in the condensed statements of comprehensive loss. Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy: ● Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets; ● Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and ● Level 3 inputs: Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. As of March 31, 2023 and December 31, 2022, the fair values of cash and cash equivalents, accounts receivable, contract asset, prepaid and other assets, accounts payable, 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 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 three months ended March 31, 2023 and 2022. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of March 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 22 $ 22 $ — $ — Total assets at fair value $ 22 $ 22 $ — $ — 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 measured at fair value on a recurring basis using observable level 1 inputs for the three months ended March 31, 2023 and 2022 (in thousands): 2023 2022 Short-term investments Balance as of beginning of period $ 49 $ 219 Unrealized loss (27 ) (84 ) Balance as of end of period $ 22 $ 135 The following table provides a roll-forward of the warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the three months ended March 31, 2023 and 2022 (in thousands): 2023 2022 Warrant liabilities Balance as of beginning of period $ — $ — Change in fair value of warrant liabilities — — Balance as of end of period $ — $ — The fair value of the warrant liabilities associated with the Rexahn warrants was de minimis during the periods presented. See Note 2 - Merger. 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”. The ASU sets forth a current expected credit loss (“CECL”) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. The Company adopted this ASU on January 1, 2023 and it did not have a significant impact on its condensed financial statements. 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 In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency of government assistance including the disclosure of the types of assistance, an entity’s accounting for the assistance, and the effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted this guidance on January 1, 2022 and it did not have a material impact to the condensed financial statements. |
Merger
Merger | 3 Months Ended |
Mar. 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 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. As of March 31, 2023, no payments subject to the CVR had been received beyond those previously reported in the second and third quarters of calendar year 2021. In addition, no milestones had been accrued as there were no potential milestones yet considered probable beyond those previously reported. 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 March 31, 2023, 60,713 of the Rexahn warrants remained outstanding with exercise prices ranging from $38.40 to $136.80 per share with an average remaining contractual life of 0.8 years. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 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 8 — Apexian Sublicense Agreement). As of March 31, 2023, there was sufficient uncertainty with regard to any future cash milestone payments under the sublicense agreement, and as such, no liabilities were recorded related to the sublicense agreement. Facility Leases The Company has a short-term non-cancellable facility lease (the “HQ Lease”) for its operations and headquarters. The HQ Lease qualified for the short-term lease exception under ASC 842, Leases. The monthly base rent, as amended, for the HQ Lease is approximately $3,000 27,000 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 | 3 Months Ended |
Mar. 31, 2023 | |
Supplemental Balance Sheet Information [Abstract] | |
Supplemental Balance Sheet Information | 4. Supplemental Balance Sheet Information Prepaid and Other Assets Prepaid and other assets consist of the following (in thousands): March 31, 2023 December 31, 2022 Prepaids $ 1,010 $ 1,373 Other 78 80 Total prepaids and other assets $ 1,088 $ 1,453 Property and Equipment, net Property and equipment held for use by category are presented in the following table (in thousands): March 31, 2023 December 31, 2022 Equipment $ 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (20 ) (19 ) Property and equipment, net $ 5 $ 6 Depreciation expense was $1,000 during each of the three months ended March 31, 2023 and 2022. Accrued Expenses Accrued expenses consist of the following (in thousands): March 31, December 31, 2023 2022 Income taxes $ 315 $ 315 Payroll 233 782 Professional services 222 208 R&D services and supplies 1,120 212 Other 43 167 Total $ 1,933 $ 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 $5,000 was recognized in connection with the Loan during the three months ended March 31, 2022. No interest expense was recognized during the three months ended March 31, 2023. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions On April 8, 2022, Ocuphire entered into a consulting agreement with Jay Pepose, a director of the Company. The consulting agreement provided for $ 10,000 50,000 25% 36 75,000 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 6. S tockholders’ Equity At-The-Market Program On February 4, 2021, Ocuphire filed a Form S-3 shelf registration under the Securities Act of 1933 which was declared effective by the SEC on February 12, 2021 (the “2021 Shelf”) under which the Company may offer and sell, from time to time in its sole discretion, securities having an aggregate offering price of up to $125 million. In connection with the 2021 Shelf, on March 11, 2021, Ocuphire entered into a sales agreement with JonesTrading Institutional Services LLC (“JonesTrading”) under which the Company may offer and sell, from time to time at its sole discretion, to or through JonesTrading, acting as agent and/or principal, shares of its common stock having an aggregate offering price of up to $40 million (the “2021 ATM”). During the three months ended March 31, 2022, 336,544 shares of common stock were sold under the 2021 ATM for gross proceeds in the amount of $1.2 million before deducting issuance expenses, including the placement agent’s fees, legal and accounting expenses, in the amount of $35,000. There were no sales of common stock under the 2021 ATM during the three-month period ended March 31, 2023. Registered Direct Offering On June 4, 2021, the Company entered into a placement agency agreement 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 3,076,923 shares of the Company’s common stock and warrants to purchase 1,538,461 shares of the Company’s common stock (the “RDO Warrants”). The RDO Warrants are equity classified, have an exercise price of $6.09 per share, are exercisable from the initial issuance date of June 8, 2021, and will expire five years following the initial issuance date. As of March 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 March 31, 2023. The Series A Warrants were accounted for and classified as equity on the accompanying condensed 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 at March 31, 2023 as the remaining 17,869 warrants were exercised for shares of common stock during the first quarter of 2023. The Series B Warrants were accounted for and classified as equity on the accompanying condensed balance sheets while outstanding. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-based Compensation [Abstract] | |
Stock-based Compensation | 7. Stock-based Compensation Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying condensed statements of comprehensive loss for the three-month periods indicated below (in thousands): March 31, 2023 2022 General and administrative $ 468 $ 295 Research and development 336 150 Total stock-based compensation $ 804 $ 445 Ocuphire Stock Options Inducement Plan On February 22, 2021, the Company adopted the Ocuphire Pharma, Inc. Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 325,258 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. 2020 Equity Incentive Plan The stockholders of the Company approved the 2020 Equity Incentive Plan (the “2020 Plan”) for stock-based awards. The 2020 Plan became effective on November 5, 2020. 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. The 2020 Plan permits the grant of incentive and non-statutory stock options, appreciation rights, restricted stock, restricted stock units, performance stock and net loss 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. 2020 Plan Evergreen Provision Under the 2020 Plan, the shares reserved automatically increase on January 1 of each year, for a period of not more than ten years from the date the 2020 Plan is approved by the stockholders of the Company, commencing on January 1, 2021 and ending on (and including) January 1, 2030, by an amount equal to 5% of the shares of common stock outstanding as of December 31st of the preceding calendar year. Notwithstanding the foregoing, the Board of Directors may act prior to January 1st of a given year to provide that there will be no January 1 increase in the share reserve for such year or that the increase in the share reserve for such year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding sentence. On January 1, 2023, 1,043,066 shares were added to the 2020 Plan as a result of the evergreen provision. Stock Options During the three months ended March 31, 2023 and 2022, 665,383 and 552,305 options were granted to officers, employees and consultants, respectively, generally vesting over a five (5) to forty-eight (48) month period. The Company recognized $500,000 and $417,000 in stock-based compensation expense related to stock options during the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023 and December 31, 2022, 3,601,427 and 2,936,044 stock options were outstanding, respectively. The weighted average fair value per share of options granted during the three months ended March 31, 2023 and 2022 was $2.75 and $2.29, respectively. The Company measures the fair value of stock options with service‑based vesting criteria to employees, directors, consultants and directors on the date of grant using the Black‑Scholes option pricing model. The Company does not have sufficient share trading 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, the Company considered characteristics such as industry, length of trading history, and stage of life cycle. The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. 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 midpoint 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 weighted average assumptions used in the Black‑Scholes option pricing model are as follows during the three months ended March 31, 2023 and 2022: 2023 2022 Expected stock price volatility 95.4 % 99.6 % Expected life of options (years) 6.1 6.0 Expected dividend yield — % — % Risk free interest rate 3.7 % 1.7 % During the three months ended March 31, 2023 and 2022, 246,068 and 62,698 stock options vested, respectively. The weighted average fair value per share of options vesting during the three months ended March 31, 2023 and 2022 was $2.44 and $2.90, respectively. During the three months ended March 31, 2023 and 2022, zero and 24,309 stock options were exercised, respectively, with an intrinsic value of zero and $59,000, respectively. Restricted Stock Units During the three months ended March 31, 2023, the Company granted an aggregate of 291,584 restricted stock units (“RSUs”) to certain officers and employees under the 2020 Plan. The weighted average grant date fair value of the RSUs granted during the three months ended March 31, 2023 was $3.50 per unit. The RSUs vest over a four year period with 25 percent vesting annually on each anniversary of the grant date, subject to the recipient’s continued service on such dates. During the three months ended March 31, 2023, no RSUs vested and no RSUs were forfeited during this period. The total expense for the three months ended March 31, 2023 related to these RSUs was $57,000. Common Stock Issued for Services The Company granted stock for services in the amount of 68,646 and 8,024 common shares during the three months ended March 31, 2023 and 2022, respectively, to four and two board members during these 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 $247,000 and $28,000 during the three months ended March 31, 2023 and 2022, respectively. General As of March 31, 2023, 912,373 shares were available for future issuance under the 2020 Plan and Inducement Plan in the aggregate. No shares were available for future issuance under the 2018 Plan. Unrecognized stock-based compensation cost was $4.9 million as of March 31, 2023. The unrecognized stock-based expense is expected to be recognized over a weighted average period of 1.7 years. |
Apexian Sublicense Agreement
Apexian Sublicense Agreement | 3 Months Ended |
Mar. 31, 2023 | |
Apexian Sublicense Agreement [Abstract] | |
Apexian Sublicense Agreement | 8. 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 wet 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 March 31, 2023 or December 31, 2022 . |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2023 | |
License and Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 9. License and Collaboration Agreements Nyxol License Agreement On November 6, 2022 Under the terms of the Nyxol License Agreement, the Company in partnership with Viatris, will develop the Nyxol Products in the United States. Viatris will reimburse the Company for budgeted costs related to the development of the Nyxol Products through FDA approval. Viatris will be responsible for developing the Nyxol 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 Nyxol Products. The committee is composed of an equal number of representatives of Viatris and Ocuphire. Viatris will commercialize the Nyxol Products in the Viatris Territory for each indication that receives regulatory approval. Pursuant to the Nyxol License Agreement, the Company received a one-time non-refundable cash payment of $35 million in November 2022 for the exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize the Nyxol Products in the Viatris Territory. In addition, with respect to each Nyxol Product, the Company will be eligible to receive potential additional payments of up to $130 million in the aggregate upon achieving certain specified regulatory or net sales milestones, with the first potential payment of $10 million to be made following approval by the FDA of Nyxol for reversal of mydriasis. The Company will also receive tiered royalties, starting at low double-digit royalties up to low twenty percent royalties, based on the aggregate annual net sales of all Nyxol Products in the United States, and will receive low double digit royalties based on all annual net sales in the Viatris Territory outside of the United States. The royalty payments will continue on a country-by-country basis from the date of the first commercial sale of the first Nyxol Product in a country of the Viatris Territory until December 31, 2040. Either party may terminate the Nyxol License Agreement upon written notice in the case of the other party’s material breach (subject to applicable cure periods) or if the other party becomes subject to an insolvency event. In addition, the Company may terminate the agreement in its entirety if 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 Nyxol License Agreement. Additionally, if Viatris determines not to pursue development or commercialization of a Product in a country or jurisdiction in the Viatris Territory, Viatris may terminate the license with respect to such Product in such country or jurisdiction. Both Ocuphire and Viatris have agreed to indemnify the other party against certain losses and expenses relating to any breach of the indemnifying party’s obligations, representations, warranties or covenants under the Nyxol License Agreement. The Nyxol License Agreement was accounted for under the provisions of ASC 606. In accordance with the provisions 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 Nyxol 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 March 31, 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 transfer was determined based on a discounted royalty cash flow approach, taking into consideration assumptions, including projected worldwide net profit for each of the respective programs based on probability assessments, projections based on internal forecasts, industry data, and information from other guideline companies within the same industry and other relevant factors. The SSP for the research and development services was determined using a cost plus margin approach, based on anticipated expenditure outlays within the first 120-day non-cancellation window. On a relative SSP basis, $39.3 million and $0.7 million of the transaction price was allocated to the license transfer and to the research and development services obligations, respectively. Recognition of Revenue The Company determined that the licenses transferred represented functional intellectual property. As such, the revenue related to the licenses was recognized at the point in time in which the license/know-how was delivered to Viatris (as successor to Famy) 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. Revenue recognized under the Nyxol License Agreement during the three months ended March 31, 2023 was $1.7 million. Regulatory Milestones under the Nyxol License Agreement The Company has evaluated the regulatory milestones that may be received in connection with the Nyxol License Agreement. There is uncertainty that the events to obtain the regulatory milestones will be achieved given the nature of clinical development and the stage of the development of the Products. The remaining regulatory milestones will be constrained until it is probable that a significant revenue reversal will not occur. Sales Milestone and Royalty Payments Sales milestones and royalties relate predominantly to a license of intellectual property granted to 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 and royalty payments were fully constrained as of March 31, 2023 and no revenue was recognized. A reconciliation of the closing balance of the contract asset associated with the Nyxol License Agreement is as follows as of March 31, 2023 (in thousands): Contract Asset Balance as of December 31, 2022 $ 3,552 Revenue recognized 1,749 Reclassification to accounts receivable related to costs billed under the Nyxol License Agreement (2,834 ) Balance as of March 31, 2023 $ 2,467 The remaining amounts in the contract asset as of March 31, 2023 attributed to the research and development services are expected to be settled during the second quarter of 2023. BioSense License and Assignment Agreement On March 10, 2020, pre-Merger, Rexahn entered into an amendment to its collaboration and license agreement, (as amended, the “BioSense License and Assignment Agreement”) with BioSense to advance the development and commercialization of RX-3117 for all human uses in the Republic of Singapore, China, Hong Kong, Macau, and Taiwan (the “BioSense Territory”). Under the terms of the BioSense License and Assignment Agreement, the Company (i) granted BioSense an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 as a single agent for all human uses in the BioSense Territory and (ii) assigned and transferred all of the former Rexahn patents and patent applications related to RX-3117 in the BioSense Territory. The upfront payment consisted of an aggregate of $1,650,000, of which $1,550,000 was paid to Rexahn prior to the Merger 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 March 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 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 March 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 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 per share
Net loss per share | 3 Months Ended |
Mar. 31, 2023 | |
Net loss per share [Abstract] | |
Net loss per share | 10. Net loss per share Basic l oss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s warrants, stock options, RSUs and any unissued common stock for services, while outstanding, are considered common stock equivalents for this purpose. Diluted earnings is computed utilizing the treasury method for the warrants, stock options, RSUs and any unissued common stock for services. No incremental common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the periods presented The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three-month periods ended presented below: March 31, 2023 2022 Series A, Series B, and RDO warrants 7,204,299 7,282,999 Stock options 3,601,427 2,616,544 RSUs 291,584 — Unissued common stock for services — 8,024 Former Rexahn warrants 60,713 66,538 Former Rexahn options — 82 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | 11. Income Taxes The effective tax rate for the three months ended March 31, 2023 and 2022 was zero percent. As of March 31, 2023, a full valuation allowance has been established to reduce the Company’s net deferred income tax assets. As such, no tax benefit related to the Company’s pre-tax loss was recognized for any of the periods presented. The Company’s corporate returns are subject to examination for tax years beginning in 2019 for federal income tax purposes and subject to examination in various state jurisdictions. The Company does not have any reserves for income taxes that represent the Company’s potential liability for uncertain tax positions. |
Deferred Compensation Plan
Deferred Compensation Plan | 3 Months Ended |
Mar. 31, 2023 | |
Deferred Compensation Plan [Abstract] | |
Deferred Compensation Plan | 12. Deferred Compensation Plan Effective October 1st 2021, the Company began offering a 401 (k) plan (“ 401 K Plan”) to its employees. All employees are eligible to participate in the 401 K 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 payroll-by-payroll basis. During the three months ended March 31 , 2023 and 2022, the Company contributed $34,000 and $25,000 to the 401 K Plan, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events On April 19, 2023, the Company terminated the employment of Mina Sooch, the President and Chief Executive Officer of the Company, and appointed Richard Rodgers as the Company’s interim President and Chief Executive Officer. In connection with the appointment of Richard Rodgers as interim President and Chief Executive Officer of the Company, the Company and Mr. Rodgers entered into a letter agreement concerning Mr. Rodgers’s services (the “Letter Agreement”). The Letter Agreement provides that Mr. Rodgers will receive a $40,000 monthly salary, and that Mr. Rodgers is eligible for potential prorated bonus at the discretion of the Board, at the end of his term. 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. |
Company Description and Summa_2
Company Description and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 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 ophthalmic 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 twice-a-day oral tablet designed to target multiple pathways relevant to retinal and choroidal (the vascular layer of the eye) diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual blindness. The Company has also in-licensed APX2009 and APX2014, which are second-generation product candidates and analogs of APX3330. In November 2022, the Company entered into a license and collaboration agreement (the “Nyxol License Agreement”) with FamyGen Life Sciences, Inc. (acquired by Viatris, Inc. (“Viatris”) in January 2023) pursuant to which it granted Viatris an exclusive license to develop, manufacture, import, export and commercialize its refractive product candidate phentolamine ophthalmic solution 0.75% (Nyxol® Eye Drops or “Nyxol”). Nyxol is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. Nyxol can potentially be used across multiple indications such as treatment of pharmacologically-induced mydriasis (“RM”) (dilation of the pupil), presbyopia (age-related blurry near vision) and dim light or night vision disturbances (“DLD”) (halos, glares and starbursts) . |
Reverse Merger with Rexahn | Reverse Merger with Rexahn On June 17, 2020, Ocuphire, Rexahn Pharmaceuticals, Inc. (“Rexahn”), Razor Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rexahn (“Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization, as amended on June 29, 2020 (as amended, the “Merger Agreement”), pursuant to which, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub would merge with and into Ocuphire, with Ocuphire continuing as a wholly-owned subsidiary of Rexahn and the surviving corporation of the merger (the “Merger”). The Merger closed on November 5, 2020. Upon completion of the Merger, Rexahn changed its name to Ocuphire Pharma, Inc. and changed its ticker symbol on the Nasdaq Capital Market to “OCUP”. The Company’s headquarters is located in Farmington Hills, Michigan. |
Basis of Presentation | Basis of Presentation The accompanying condensed financial statements have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The December 31, 2022 condensed balance sheet was derived from audited financial statements, and may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2022. In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods. On December 31, 2021, the Company merged its wholly-owned subsidiary, OcuSub Inc, with and into the Company, with the Company remaining as the surviving entity. The merger of the Company’s wholly-owned subsidiary did not have a financial impact in the periods presented. Upon close of this merger, the Company did not have any remaining entities that required consolidation for financial statement reporting purposes. All significant intercompany accounts and transactions were eliminated in the preparation of the condensed financial statements prior to the December 31, 2021 merger with OcuSub Inc |
Liquidity | Liquidity The accompanying condensed 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 March 31, 2023, the Company had $39.0 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 12 months following May 15, 2023, which is the date that these condensed financial statements are being issued. In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the ultimate outcome of these actions to generate the liquidity ultimately required. |
Use of Estimates | Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from those estimates. |
Segment Information | Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development 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. The Company’s cash is held or managed by one financial institution in the United States. Amounts on deposit exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. In addition, the Company limits its exposure through the kind, quality and concentration of its investments. As of March 31, 2023, the Company had deposits that exceeded federally insured amounts by $38.7 million. |
Short-term Investments | Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and are recorded on a settlement date basis. The Company’s 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 condensed statements of comprehensive loss. The Company classifies investments available to fund current operations as current assets on its balance sheets. The Company did not recognize any impairments on its investments to date through March 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 : If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other obligations, such as research and development services, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. For research and development services that are distinct from a license transfer obligation, the Company determines whether the services are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from such services. Milestone payments : At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until such contingency occurs (such as receipt of those approvals). Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). |
Contract Asset | Contract Asset The Company recognizes a contract asset when goods or services are transferred to the customer before the customer pays or before payment is due, excluding any amounts presented as an accounts receivable. The Company recorded a contract asset in connection with a license and collaboration agreement in the amount of $2.5 million as of March 31, 2023. See Note 9- License and Collaboration Agreements. |
Accounts Receivable and Allowances for Doubtful Accounts | Accounts Receivable and Allowances for Doubtful Accounts The Company records a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable. In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable, its historical write-offs, the credit worthiness of each customer, and 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. The Company has not incurred any bad debt expense to date and no allowance for doubtful accounts has been recorded during the periods presented. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses (“G&A”) consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, settlement costs with third parties and other services provided by business consultants. |
Research and Development | Research and Development Research and development expenses (“R&D”) consist of costs incurred in performing research and development activities, including compensation for research and development employees and consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, fees paid to external service providers that conduct certain research and development, and an allocation of R&D related overhead expenses. R&D costs include costs that are reimbursed under the Nyxol License Agreement. |
Other Income (Expense), net | Other Income (Expense), net Other income (expense), net reflected in this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former Rexahn shareholders. In addition, other 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 occur. |
Stock-based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC 718”), Compensation — Stock Compensation. Accordingly, compensation costs related to equity instruments granted are recognized at the grant date fair value. The Company records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable provisions of ASC 718. |
Warrant Liabilities | Warrant Liabilities The Company assumed Rexahn warrants issued prior to the Merger. The Company accounts for these warrants as a liability while outstanding at fair value during periods when certain provisions preclude equity accounting treatment for these instruments. The change in fair value of the warrant liabilities while outstanding are recognized as a component of the fair value change in warrant liabilities line item in the condensed statements of comprehensive loss. |
Fair Value Measurements | Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy: ● Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets; ● Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and ● Level 3 inputs: Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. As of March 31, 2023 and December 31, 2022, the fair values of cash and cash equivalents, accounts receivable, contract asset, prepaid and other assets, accounts payable, 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 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 three months ended March 31, 2023 and 2022. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of March 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 22 $ 22 $ — $ — Total assets at fair value $ 22 $ 22 $ — $ — 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 measured at fair value on a recurring basis using observable level 1 inputs for the three months ended March 31, 2023 and 2022 (in thousands): 2023 2022 Short-term investments Balance as of beginning of period $ 49 $ 219 Unrealized loss (27 ) (84 ) Balance as of end of period $ 22 $ 135 The following table provides a roll-forward of the warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the three months ended March 31, 2023 and 2022 (in thousands): 2023 2022 Warrant liabilities Balance as of beginning of period $ — $ — Change in fair value of warrant liabilities — — Balance as of end of period $ — $ — The fair value of the warrant liabilities associated with the Rexahn warrants was de minimis during the periods presented. See Note 2 - Merger. 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”. The ASU sets forth a current expected credit loss (“CECL”) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. The Company adopted this ASU on January 1, 2023 and it did not have a significant impact on its condensed financial statements. 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 In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency of government assistance including the disclosure of the types of assistance, an entity’s accounting for the assistance, and the effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted this guidance on January 1, 2022 and it did not have a material impact to the condensed financial statements. |
Company Description and Summa_3
Company Description and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 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 March 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 22 $ 22 $ — $ — Total assets at fair value $ 22 $ 22 $ — $ — 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 Measured on a Recurring Basis | The following table provides a roll-forward of short-term investments measured at fair value on a recurring basis using observable level 1 inputs for the three months ended March 31, 2023 and 2022 (in thousands): 2023 2022 Short-term investments Balance as of beginning of period $ 49 $ 219 Unrealized loss (27 ) (84 ) Balance as of end of period $ 22 $ 135 |
Warrant Liabilities Measured at Fair Value on a Recurring Basis | The following table provides a roll-forward of the warrant liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the three months ended March 31, 2023 and 2022 (in thousands): 2023 2022 Warrant liabilities Balance as of beginning of period $ — $ — Change in fair value of warrant liabilities — — Balance as of end of period $ — $ — |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Supplemental Balance Sheet Information [Abstract] | |
Prepaid and Other Assets | Prepaid and other assets consist of the following (in thousands): March 31, 2023 December 31, 2022 Prepaids $ 1,010 $ 1,373 Other 78 80 Total prepaids and other assets $ 1,088 $ 1,453 |
Property and Equipment, Net | Property and equipment held for use by category are presented in the following table (in thousands): March 31, 2023 December 31, 2022 Equipment $ 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (20 ) (19 ) Property and equipment, net $ 5 $ 6 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): March 31, December 31, 2023 2022 Income taxes $ 315 $ 315 Payroll 233 782 Professional services 222 208 R&D services and supplies 1,120 212 Other 43 167 Total $ 1,933 $ 1,684 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 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 condensed statements of comprehensive loss for the three-month periods indicated below (in thousands): March 31, 2023 2022 General and administrative $ 468 $ 295 Research and development 336 150 Total stock-based compensation $ 804 $ 445 |
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 three months ended March 31, 2023 and 2022: 2023 2022 Expected stock price volatility 95.4 % 99.6 % Expected life of options (years) 6.1 6.0 Expected dividend yield — % — % Risk free interest rate 3.7 % 1.7 % |
License and Collaboration Agr_2
License and Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
License and Collaboration Agreements [Abstract] | |
Reconciliation of Contract Asset Associated | A reconciliation of the closing balance of the contract asset associated with the Nyxol License Agreement is as follows as of March 31, 2023 (in thousands): Contract Asset Balance as of December 31, 2022 $ 3,552 Revenue recognized 1,749 Reclassification to accounts receivable related to costs billed under the Nyxol License Agreement (2,834 ) Balance as of March 31, 2023 $ 2,467 |
Net loss per share (Tables)
Net loss per share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net loss per share [Abstract] | |
Anti-dilutive Securities Excluded from Computation of Net Loss per Share | The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three-month periods ended presented below: March 31, 2023 2022 Series A, Series B, and RDO warrants 7,204,299 7,282,999 Stock options 3,601,427 2,616,544 RSUs 291,584 — Unissued common stock for services — 8,024 Former Rexahn warrants 60,713 66,538 Former Rexahn options — 82 |
Company Description and Summa_4
Company Description and Summary of Significant Accounting Policies, Liquidity (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Liquidity [Abstract] | ||
Cash and cash equivalents | $ 38,988 | $ 42,634 |
Company Description and Summa_5
Company Description and Summary of Significant Accounting Policies, Segment Information (Details) | 3 Months Ended |
Mar. 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 | Mar. 31, 2023 USD ($) |
Concentration of Credit Risk [Abstract] | |
Deposits that exceeded federally insured amounts | $ 38.7 |
Company Description and Summa_7
Company Description and Summary of Significant Accounting Policies, Short-term Investments (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Other than Temporary Impairment Losses, Investments [Abstract] | |
Impairment on investments | $ 0 |
Company Description and Summa_8
Company Description and Summary of Significant Accounting Policies, Contract Asset and Accounts Receivable and Allowances for Doubtful Accounts (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Contract Asset and Accounts Receivable and Allowances for Doubtful Accounts [Abstract] | ||
Contract asset (Note 9) | $ 2,467 | $ 3,552 |
Bad debt expense | 0 | |
Allowance for doubtful accounts | $ 0 | $ 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 | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | 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 | 22 | $ 49 | |
Recurring Basis [Member] | Short-Term Investments [Member] | |||
Assets [Abstract] | |||
Assets at fair value | 22 | 49 | |
Recurring Basis [Member] | Level 1 [Member] | |||
Assets [Abstract] | |||
Assets at fair value | 22 | 49 | |
Recurring Basis [Member] | Level 1 [Member] | Short-Term Investments [Member] | |||
Assets [Abstract] | |||
Assets at fair value | 22 | 49 | |
Recurring Basis [Member] | Level 2 [Member] | |||
Assets [Abstract] | |||
Assets at fair value | 0 | 0 | |
Recurring Basis [Member] | Level 2 [Member] | Short-Term Investments [Member] | |||
Assets [Abstract] | |||
Assets at fair value | 0 | 0 | |
Recurring Basis [Member] | Level 3 [Member] | |||
Assets [Abstract] | |||
Assets at fair value | 0 | 0 | |
Recurring Basis [Member] | Level 3 [Member] | Short-Term Investments [Member] | |||
Assets [Abstract] | |||
Assets at fair value | $ 0 | $ 0 |
Company Description and Summ_10
Company Description and Summary of Significant Accounting Policies, Equity Investments Measured at Fair Value (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Equity Investments [Abstract] | ||
Unrealized loss | $ (27) | $ (84) |
Recurring Basis [Member] | Level 1 [Member] | Short-Term Investments [Member] | ||
Equity Investments [Abstract] | ||
Balance as of beginning of period | 49 | 219 |
Unrealized loss | (27) | (84) |
Balance as of end of period | $ 22 | $ 135 |
Company Description and Summ_11
Company Description and Summary of Significant Accounting Policies, Warrant Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Level 3 [Member] | Warrant Liabilities [Member] | |||
Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |||
Balance as of beginning of period | $ 0 | $ 0 | |
Change in fair value of warrant liabilities | 0 | 0 | |
Balance as of end of period | 0 | $ 0 | |
Fair Value, Nonrecurring [Member] | |||
Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |||
Financial instruments liabilities at fair value | $ 0 | $ 0 |
Merger, Summary (Details)
Merger, Summary (Details) | 3 Months Ended | |||
Mar. 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 | 3 Months Ended | |
Mar. 31, 2023 | Nov. 05, 2020 | |
Former Rexahn Warrants [Abstract] | ||
Number of warrants outstanding (in shares) | 60,713 | 231,433 |
Average remaining contractual life | 9 months 18 days | |
Minimum [Member] | ||
Former Rexahn Warrants [Abstract] | ||
Exercise price (in dollars per share) | $ 38.4 | |
Maximum [Member] | ||
Former Rexahn Warrants [Abstract] | ||
Exercise price (in dollars per share) | $ 136.8 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Facility Lease [Abstract] | ||
Monthly base rent | $ 3,000 | |
Rent expense | 9,000 | $ 12,000 |
Expected rent payment for the year end 2023 | $ 27,000 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information, Prepaid and Other Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid and Other Assets [Abstract] | ||
Prepaids | $ 1,010 | $ 1,373 |
Other | 78 | 80 |
Total prepaids and other assets | $ 1,088 | $ 1,453 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information, Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Property and Equipment, net [Abstract] | |||
Total property and equipment | $ 25 | $ 25 | |
Less accumulated depreciation | (20) | (19) | |
Property and equipment, net | 5 | 6 | |
Depreciation expense | 1 | $ 1 | |
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 | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses [Abstract] | ||
Income taxes | $ 315 | $ 315 |
Payroll | 233 | 782 |
Professional services | 222 | 208 |
R&D services and supplies | 1,120 | 212 |
Other | 43 | 167 |
Total | $ 1,933 | $ 1,684 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information, Short-Term Loan (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2023 USD ($) Intallment | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 30, 2021 USD ($) | |
Short-Term Loan [Abstract] | ||||
Short term loan | $ 600 | |||
Number of installments | Intallment | 6 | |||
Annual interest rate | 5.50% | |||
Interest expense | $ 0 | $ 5 | ||
Short-term Loan [Member] | ||||
Short-Term Loan [Abstract] | ||||
Payment on short term loan | $ 108 |
Related Party Transactions (Det
Related Party Transactions (Details) - Jay Pepose [Member] - USD ($) | 3 Months Ended | ||||
Apr. 08, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 01, 2022 | |
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 | $ 75,000 | $ 0 | |||
Consulting expenses unpaid | $ 50,000 | $ 25,000 | |||
Vested on March 31, 2023 [Member] | |||||
Pre-Merger Financing and Waiver Agreements [Abstract] | |||||
Vesting percentage | 25% |
Stockholders' Equity, At-The-Ma
Stockholders' Equity, At-The-Market Program (Details) - USD ($) | 3 Months Ended | |||
Mar. 11, 2021 | Feb. 12, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
At-The-Market Program [Abstract] | ||||
Issuance expenses | $ 0 | $ 30,000 | ||
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) | 0 | 336,544 | ||
Gross proceeds | $ 1,200,000 | |||
Issuance expenses | $ 35,000 | |||
ATM [Member] | Maximum [Member] | ||||
At-The-Market Program [Abstract] | ||||
Aggregate offering price | $ 40,000,000 |
Stockholders' Equity, Registere
Stockholders' Equity, Registered Direct Offering (Details) - Registered Direct Offering [Member] - $ / shares | Jun. 08, 2021 | Mar. 31, 2023 |
Warrants [Member] | ||
Registered Direct Offerings [Abstract] | ||
Exercise price (in dollars per share) | $ 6.09 | |
Expiration period | 5 years | |
Warrants outstanding (in shares) | 1,538,461 | |
Common Stock [Member] | ||
Registered Direct Offerings [Abstract] | ||
Shares sold (in shares) | 3,076,923 | |
Warrants issued (in shares) | 1,538,461 |
Stockholders' Equity, Pre-Merge
Stockholders' Equity, Pre-Merger Financing, Series A & B Warrants (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Jun. 29, 2020 USD ($) Director | Mar. 31, 2023 $ / shares shares | Nov. 19, 2020 $ / shares shares | Nov. 05, 2020 shares | |
Rexahn [Member] | ||||
Pre-Merger Financing [Abstract] | ||||
Warrants outstanding (in shares) | 60,713 | 231,433 | ||
Securities Purchase Agreement [Member] | ||||
Pre-Merger Financing [Abstract] | ||||
Number of directors | Director | 5 | |||
Securities Purchase Agreement [Member] | Rexahn [Member] | ||||
Pre-Merger Financing [Abstract] | ||||
Number of directors | Director | 1 | |||
Securities Purchase Agreement [Member] | Investors [Member] | ||||
Pre-Merger Financing [Abstract] | ||||
Total investment | $ | $ 21,150 | |||
Securities Purchase Agreement [Member] | Directors [Member] | ||||
Pre-Merger Financing [Abstract] | ||||
Total investment | $ | $ 300 | |||
Series A Warrants [Member] | ||||
Pre-Merger Financing [Abstract] | ||||
Exercise price (in dollars per share) | $ / shares | $ 4.4795 | |||
Exercisable term | 5 years | |||
Warrant issued (in shares) | 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 |
Stock-based Compensation, Stock
Stock-based Compensation, Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation | $ 804 | $ 445 |
General and Administrative [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation | 468 | 295 |
Research and Development [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Stock based compensation | $ 336 | $ 150 |
Stock-based Compensation, Sto_2
Stock-based Compensation, Stock Option Plan Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||||
Jan. 01, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Feb. 22, 2021 | Nov. 05, 2020 | Dec. 31, 2019 | |
Ocuphire Stock Options [Abstract] | |||||||
Stock based compensation | $ 804 | $ 445 | |||||
2020 Equity Incentive Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 1,000,000 | ||||||
2020 Equity Incentive Plan [Member] | Maximum [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 70,325 | ||||||
2018 Equity Incentive Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 0 | 1,175,000 | |||||
Inducement Plan [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 325,258 | ||||||
2020 Plan Evergreen Provision [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Percentage of common stock shares outstanding | 5% | ||||||
Number of shares added (in shares) | 1,043,066 | ||||||
2020 Plan Evergreen Provision [Member] | Minimum [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Vesting period | 5 months | ||||||
2020 Plan Evergreen Provision [Member] | Maximum [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Period of shares reserved under plan | 10 years | ||||||
Vesting period | 48 months | ||||||
Ocuphire Stock Options [Member] | 2020 Plan Evergreen Provision [Member] | |||||||
Ocuphire Stock Options [Abstract] | |||||||
Granted (in shares) | 665,383 | 552,305 | |||||
Stock based compensation | $ 500 | $ 417 | |||||
Number of shares outstanding (in shares) | 3,601,427 | 2,936,044 | |||||
Weighted average fair value per share of options granted (in dollars per share) | $ 2.75 | $ 2.29 |
Stock-based Compensation, Weigh
Stock-based Compensation, Weighted-Average Assumptions Used in Black-Scholes Option-pricing Model (Details) - 2020 Plan Evergreen Provision [Member] - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Weighted-average Assumptions Used in Black-Scholes Option-pricing Model [Abstract] | ||
Expected stock price volatility | 95.40% | 99.60% |
Expected life of options | 6 years 1 month 6 days | 6 years |
Expected dividend yield | 0% | 0% |
Risk free interest rate | 3.70% | 1.70% |
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||
Stock options vested (in shares) | 246,068 | 62,698 |
Weighted average fair value per share of options vesting (in dollars per share) | $ 2.44 | $ 2.9 |
Stock option exercised (in shares) | 0 | 24,309 |
Aggregate intrinsic value | $ 0 | $ 59,000 |
Stock options forfeited (in shares) | 0 | 8,288 |
Stock-based Compensation, Restr
Stock-based Compensation, Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Restricted Stock Units [Abstract] | ||
Stock based compensation | $ 804 | $ 445 |
Restricted Stock Units [Member] | ||
Restricted Stock Units [Abstract] | ||
Vested (in shares) | 0 | |
Forfeited (in shares) | 0 | |
Stock based compensation | $ 57 | |
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | ||
Restricted Stock Units [Abstract] | ||
Granted (in shares) | 291,584 | |
Weighted average grant date fair value of RSUs granted (in dollars per share) | $ 3.5 | |
Vesting period | 4 years | |
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | Vesting Annually [Member] | ||
Restricted Stock Units [Abstract] | ||
Vesting percentage | 25% |
Stock-based Compensation, Commo
Stock-based Compensation, Common Stock Issued for Services (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 USD ($) Member shares | Mar. 31, 2022 USD ($) Member shares | |
Common Stock Issued for Services [Abstract] | ||
Granted stock awards for services performed (in shares) | shares | 68,646 | 8,024 |
Number of board members, stock granted for services | Member | 4 | 2 |
Share based compensation for services | $ | $ 247 | $ 28 |
Stock-based Compensation, Gener
Stock-based Compensation, General (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) shares | |
General [Abstract] | |
Unrecognized stock-based compensation cost | $ | $ 4.9 |
Weighted average period to recognized stock-based compensation | 1 year 8 months 12 days |
2020 Plan Evergreen Provision [Member] | |
General [Abstract] | |
Common stock available for future issuance (in shares) | 912,373 |
Inducement Plan [Member] | |
General [Abstract] | |
Common stock available for future issuance (in shares) | 912,373 |
2018 Equity Incentive Plan [Member] | |
General [Abstract] | |
Common stock available for future issuance (in shares) | 0 |
Apexian Sublicense Agreement (D
Apexian Sublicense Agreement (Details) - Apexian Sublicense Agreement [Member] - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 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 |
License and Collaboration Agr_3
License and Collaboration Agreements, Nyxol License Agreement (Details) | 1 Months Ended | 3 Months Ended | ||
Nov. 30, 2022 USD ($) | Mar. 31, 2023 USD ($) Performanceobligation | Mar. 31, 2022 USD ($) | Nov. 06, 2022 USD ($) | |
Collaboration and License Agreement [Abstract] | ||||
Revenue recognized | $ 1,749,000 | $ 0 | ||
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Beginning Balance | 3,552,000 | |||
Revenue recognized | 1,749,000 | $ 0 | ||
Ending Balance | $ 2,467,000 | |||
Nyxol License Agreement [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Non-refundable cash payment received | $ 35,000,000 | |||
Maximum amount of payments receivable for development, regulatory and commercial milestones | $ 130,000,000 | |||
First potential payments to be received | $ 10,000,000 | |||
Maximum percentage of tiered royalties receivable | 20% | |||
Number of distinct performance obligations | Performanceobligation | 2 | |||
Aggregate transaction price to be recognized | $ 40,000,000 | |||
Period of non-cancellation window agreement | 120 days | |||
Non-cancellation period of constrained | 120 days | |||
Revenue recognized | $ 1,749,000 | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Beginning Balance | 3,552,000 | |||
Revenue recognized | 1,749,000 | |||
Ending Balance | 2,467,000 | |||
Nyxol License Agreement [Member] | License Transfer Fee [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Aggregate transaction price to be recognized | 35,000,000 | |||
Estimated standalone selling price for license agreement | 287,800,000 | |||
Transaction price allocation of ESSP obligations | 39,300,000 | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | ||||
Reclassification to accounts receivable related to costs billed under the Nyxol License Agreement | (2,834,000) | |||
Nyxol License Agreement [Member] | Research and Development Services [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Aggregate transaction price to be recognized | 5,000,000 | |||
Estimated standalone selling price for license agreement | 5,000,000 | |||
Transaction price allocation of ESSP obligations | 700,000 | |||
Nyxol License Agreement [Member] | Sales Milestones [Member] | ||||
Collaboration and License Agreement [Abstract] | ||||
Revenue recognized | 0 | |||
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) | 3 Months Ended | 12 Months Ended | |
Mar. 10, 2020 USD ($) | Mar. 31, 2023 USD ($) 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 | ||
Maximum amount of payments receivable for development, regulatory and commercial milestones | $ 84,500,000 | ||
Milestone payments received | 0 | ||
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 per share (Details)
Net loss per share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Series A, Series B and RDO Warrants [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 7,204,299 | 7,282,999 |
Stock Options [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 3,601,427 | 2,616,544 |
RSUs [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 291,584 | 0 |
Unissued Common Stock for Services [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 0 | 8,024 |
Former Rexahn Warrants [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 60,713 | 66,538 |
Former Rexahn Options [Member] | ||
Net Loss Per Share [Abstract] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 0 | 82 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Taxes [Abstract] | ||
Effective tax rate | 0% | 0% |
Income tax expense (benefit) | $ 0 | $ 0 |
Deferred Compensation Plan (Det
Deferred Compensation Plan (Details) - 401K Plan [Member] - USD ($) | 3 Months Ended | ||
Oct. 01, 2021 | Mar. 31, 2023 | Mar. 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 | $ 34,000 | $ 25,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 3 Months Ended | ||
Apr. 19, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | |
Subsequent Events [Abstract] | |||
Restricted stock units (in shares) | 68,646 | 8,024 | |
Subsequent Event [Member] | Letter Agreement [Member] | |||
Subsequent Events [Abstract] | |||
Monthly salary | $ 40,000 | ||
Subsequent Event [Member] | Letter Agreement [Member] | 2020 Equity Incentive Plan [Member] | |||
Subsequent Events [Abstract] | |||
Restricted stock units (in shares) | 50,000 | ||
Vesting period | 12 months |