Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 09, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
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, $0.0001 par value per share | |
Trading Symbol | OCUP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,198,444 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 41,409 | $ 50,501 |
Accounts receivable | 1,358 | 926 |
Contract assets and unbilled receivables | 948 | 1,407 |
Prepaids and other assets | 1,114 | 1,099 |
Short-term investments | 5 | 15 |
Total current assets | 44,834 | 53,948 |
Property and equipment, net | 0 | 0 |
Total assets | 44,834 | 53,948 |
Current liabilities: | ||
Accounts payable | 634 | 2,153 |
Accrued expenses | 3,490 | 1,815 |
Derivative liability | 74 | 74 |
Total current liabilities | 4,198 | 4,042 |
Total liabilities | 4,198 | 4,042 |
Commitments and contingencies (Note 3 and Note 8) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023. | 0 | 0 |
Common stock, par value $0.0001; 125,000,000 and 75,000,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively; 25,979,038 and 23,977,491 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively. | 3 | 2 |
Additional paid-in capital | 136,970 | 131,370 |
Accumulated deficit | (96,337) | (81,466) |
Total stockholders' equity | 40,636 | 49,906 |
Total liabilities and stockholders' equity | $ 44,834 | $ 53,948 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
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) | 125,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 25,979,038 | 23,977,491 |
Common stock, shares outstanding (in shares) | 25,979,038 | 23,977,491 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Condensed Statements of Comprehensive Loss [Abstract] | ||||
License and collaborations revenue | $ 1,112 | $ 3,674 | $ 2,823 | $ 5,423 |
Operating expenses: | ||||
General and administrative | 3,354 | 4,340 | 8,024 | 6,625 |
Research and development | 6,086 | 4,723 | 10,835 | 10,318 |
Total operating expenses | 9,440 | 9,063 | 18,859 | 16,943 |
Loss from operations | (8,328) | (5,389) | (16,036) | (11,520) |
Other income, net | 563 | 428 | 1,165 | 768 |
Loss before income taxes | (7,765) | (4,961) | (14,871) | (10,752) |
Benefit (provision) for income taxes | 0 | 0 | 0 | 0 |
Net loss | (7,765) | (4,961) | (14,871) | (10,752) |
Other comprehensive loss, net of tax | 0 | 0 | 0 | 0 |
Comprehensive loss | $ (7,765) | $ (4,961) | $ (14,871) | $ (10,752) |
Net loss per share: | ||||
Basic (in dollars per share) | $ (0.3) | $ (0.24) | $ (0.59) | $ (0.51) |
Diluted (in dollars per share) | $ (0.3) | $ (0.24) | $ (0.59) | $ (0.51) |
Number of shares used in per share calculations: | ||||
Basic (in shares) | 25,827,265 | 20,959,807 | 25,175,596 | 20,949,763 |
Diluted (in shares) | 25,827,265 | 20,959,807 | 25,175,596 | 20,949,763 |
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, 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 | |||
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] | ||||
Net and comprehensive loss | (10,752) | |||
Balance at Jun. 30, 2023 | $ 2 | 119,934 | (82,232) | 37,704 |
Balance (in shares) at Jun. 30, 2023 | 20,985,784 | |||
Balance at Mar. 31, 2023 | $ 2 | 118,519 | (77,271) | 41,250 |
Balance (in shares) at Mar. 31, 2023 | 20,947,830 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance costs | $ 0 | (7) | 0 | (7) |
Stock-based compensation | $ 0 | 1,422 | 0 | 1,422 |
Stock-based compensation (in shares) | 37,954 | |||
Net and comprehensive loss | $ 0 | 0 | (4,961) | (4,961) |
Balance at Jun. 30, 2023 | $ 2 | 119,934 | (82,232) | 37,704 |
Balance (in shares) at Jun. 30, 2023 | 20,985,784 | |||
Balance at Dec. 31, 2023 | $ 2 | 131,370 | (81,466) | 49,906 |
Balance (in shares) at Dec. 31, 2023 | 23,977,491 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with the at-the-market program and purchase agreement | $ 1 | 2,478 | 0 | 2,479 |
Issuance of common stock in connection with the at-the-market program and purchase agreement (in shares) | 1,000,550 | |||
Issuance costs | $ 0 | (165) | 0 | (165) |
Stock-based compensation | $ 0 | 985 | 0 | 985 |
Stock-based compensation (in shares) | 120,516 | |||
Share repurchases for the payment of employee taxes | $ 0 | (42) | 0 | (42) |
Share repurchases for the payment of employee taxes (in shares) | (12,965) | |||
Net and comprehensive loss | $ 0 | 0 | (7,106) | (7,106) |
Balance at Mar. 31, 2024 | $ 3 | 134,626 | (88,572) | 46,057 |
Balance (in shares) at Mar. 31, 2024 | 25,085,592 | |||
Balance at Dec. 31, 2023 | $ 2 | 131,370 | (81,466) | 49,906 |
Balance (in shares) at Dec. 31, 2023 | 23,977,491 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net and comprehensive loss | (14,871) | |||
Balance at Jun. 30, 2024 | $ 3 | 136,970 | (96,337) | 40,636 |
Balance (in shares) at Jun. 30, 2024 | 25,979,038 | |||
Balance at Mar. 31, 2024 | $ 3 | 134,626 | (88,572) | 46,057 |
Balance (in shares) at Mar. 31, 2024 | 25,085,592 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock in connection with the at-the-market program and purchase agreement | $ 0 | 1,563 | 0 | 1,563 |
Issuance of common stock in connection with the at-the-market program and purchase agreement (in shares) | 788,566 | |||
Issuance costs | $ 0 | (25) | 0 | (25) |
Stock-based compensation | $ 0 | 806 | 0 | 806 |
Stock-based compensation (in shares) | 104,880 | |||
Net and comprehensive loss | $ 0 | 0 | (7,765) | (7,765) |
Balance at Jun. 30, 2024 | $ 3 | $ 136,970 | $ (96,337) | $ 40,636 |
Balance (in shares) at Jun. 30, 2024 | 25,979,038 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities | ||
Net loss | $ (14,871) | $ (10,752) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,791 | 2,226 |
Depreciation | 0 | 2 |
Unrealized loss from short-term investments | 10 | 27 |
Change in assets and liabilities: | ||
Accounts receivable | (432) | 1,163 |
Contract assets and unbilled receivables | 459 | 957 |
Prepaid and other assets | (15) | 721 |
Accounts payable | (1,519) | 1,254 |
Accrued and other liabilities | 1,569 | 1,745 |
Net cash used in operating activities | (13,008) | (2,657) |
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 and purchase agreement | 4,041 | 0 |
Issuance costs | (83) | 0 |
Share repurchases for the payment of employee taxes | (42) | 0 |
Net cash provided by financing activities | 3,916 | 0 |
Net decrease in cash and cash equivalents | (9,092) | (2,657) |
Cash and cash equivalents at beginning of period | 50,501 | 42,634 |
Cash and cash equivalents at end of period | 41,409 | 39,977 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 0 | 0 |
Cash paid for interest | 0 | 0 |
Supplemental non-cash financing transactions: | ||
Unpaid issuance costs | $ 107 | $ 9 |
Company Description and Summary
Company Description and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | |
Company Description and Summary of Significant Accounting Policies | 1. Company Description and Summary of Significant Accounting Policies Nature of Business Ocuphire Pharma, Inc. (the “Company” or “Ocuphire”) is a clinical-stage biopharmaceutical company with one FDA-approved product currently marketed by Viatris, Inc. (“Viatris”), our development and commercial partner. The Company’s lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1α and NF-kB. Inhibiting Ref-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet intended to be administered twice per day in development for the treatment of diabetic retinopathy (“DR”). A Phase 2 study in subjects with DR or diabetic macular edema was completed and results were reported in January 2023. An End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (the “FDA”) was held in October 2023 at which the Company obtained agreement on the registration efficacy endpoint for APX3330 in future clinical trials. Ocuphire submitted a Special Protocol Assessment (“SPA”) to the FDA in February 2024 to seek agreement on the clinical trial protocol and statistical analysis plan. The company continues dialog with the FDA and will update the market upon conclusion of these discussions. The Company has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique mechanism of action of this family of Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration, geographic atrophy, and non-ophthalmic diseases. In November 2022, the Company entered into a license and collaboration agreement (the “Viatris License Agreement”) with FamyGen Life Sciences, Inc. (acquired by and now known as Viatris, Inc. (“Viatris”)), 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% (initially known as Nyxol) (“PS”). PS is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. PS was approved by the FDA for the treatment for pharmacologically induced mydriasis under the brand name RYZUMVI TM The Company reported positive top-line data from multiple late-stage clinical trials for PS in reversal of pharmacologically induced mydriasis, presbyopia and dim light disturbances. The VEGA-2 Phase 3 study in presbyopia achieved its primary endpoint. The VEGA-3 Phase 3 clinical trial evaluating PS for presbyopia (age-related blurry near vision) has begun recruiting. For decreased vision under mesopic (low) light conditions following keratorefractive surgery, we received FDA agreement under Special Protocol Assessment for LYNX-2, a Phase 3 Trial of PS. The first patient was enrolled in LYNX-2 in April 2024. 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, 2023 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, 2023. 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. Liquidity The accompanying financial statements have been prepared on the basis that the Company will continue as a going concern. From its inception, the Company has devoted substantially all its efforts to drug development and conducting clinical trials. As of June 30, 2024, the Company had $41.4 million in cash and cash equivalents. The Company believes its current available cash and cash equivalents will be sufficient to fund the Company’s planned expenditures and meet its obligations for at least twelve months from the date of issuance of these financial statements. In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or pursue additional financing, may provide additional liquidity in the future; however, these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions taken to generate the liquidity ultimately required. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer or such person functioning in such role. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development of products related to vision performance and health. Accordingly, the Company has a single reporting segment. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of deposit to be cash equivalents. Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. Management follows approved policies established by its Board of Directors to reduce credit risk associated with the Company’s cash deposit and investment accounts. Pursuant to these policies, the Company limits its exposure through the kind, quality and concentration of its investments. The Company’s cash and cash equivalents are held or managed by two financial institutions in the United States. . These balances are invested in funds whose assets consist almost entirely of securities issued by the U.S. Treasury or guaranteed by the U.S. government . Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and records them on a settlement date basis. The Company’s short-term investments are comprised of equity securities, which in accordance with the fair value hierarchy described below are recorded at fair value using Level l inputs on the balance sheets. Subsequent changes in fair values are recorded in other income, net on the 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 June 30, 2024. Revenue Recognition The Company follows the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers 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 Assets and Unbilled Receivables The Company recognizes contract assets and unbilled receivables when goods or services are transferred to the customer before the customer pays or before reimbursement for payment is billed or due, excluding any amounts presented as an account receivable. The Company recorded contract assets and unbilled receivables in connection with a license and collaboration agreement (See Note 9 – License and Collaboration Agreements). Accounts Receivable and Allowances for Credit Losses The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. The Company estimates credit losses over the remaining expected life of an asset by, among other things, primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance. The Company has not incurred any bad debt expense to date and no allowance for credit losses has been recorded during the periods presented. General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include insurance coverage for directors and officers and other property and liability exposures, legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, other services provided by business consultants, and legal settlements. Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including compensation, benefits and stock-based compensation costs for research and development employees and costs for consultants, costs associated with nonclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses. Research and development expenses include costs that are reimbursed under the Viatris License Agreement (See Note 9 – License and Collaboration Agreements). Other Income, net Other income, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in connection with grants and other sources when they oc cur. In addition, this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former shareholders of . Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) ASC 718, Compensation — Stock Compensation. Derivative Liability The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separation from the underlying agreement under ASC 815 – Derivatives and Hedging Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy: • Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets; • Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and • Level 3 inputs: Unobservable inputs in which there is little or no market data available, which requires management to develop its own assumptions in pricing the asset or liability. As of June 30, 2024 and December 31, 2023, the fair values of cash and cash equivalents, accounts receivable, contract assets and unbilled receivables, prepaid and other assets, accounts payable, and accrued expenses approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the short-term investments, while outstanding, were based on observable Level 1 inputs in the form of quoted market prices from a major stock exchange. The fair value of the derivative liability associated with the equity line financing facility (See Note 6 – Stockholders’ Equity) was based on cash flow models discounted at current implied market rates representing expected returns by market participants for similar instruments and are based on Level 3 inputs as well the Company’s underlying stock price and associated volatility, expected term of the financing and market interest rates. 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 and six months ended June 30, 2024 and 2023. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of June 30, 2024 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 5 $ 5 $ — $ — Total assets at fair value $ 5 $ 5 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 As of December 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 15 $ 15 $ — $ — Total assets at fair value $ 15 $ 15 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 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 six months ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Short-term investments Balance as of beginning of period $ 15 $ 49 Unrealized loss (10 ) (27 ) Balance as of end of period $ 5 $ 22 The following table provides a roll-forward of the derivative liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the six months ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Derivative liabilities Balance as of beginning of period $ 74 $ — Change in fair value of derivative liabilities — — Balance as of end of period $ 74 $ — Rexahn Warrants The fair value of the warrant liabilities associated with the warrants was de minimis during the periods presented. The last of the Rexahn warrants classified as liabilities expired in April 2023 unexercised. See Note 2 – Merger for additional background. There were no financial instruments measured on a non-recurring basis for any of the periods presented. Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Merger
Merger | 6 Months Ended |
Jun. 30, 2024 | |
Merger [Abstract] | |
Merger | 2. Merger On November 5, 2020, the Company completed the Merger transaction with Rexahn (the “Merger”). 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 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 June 30, 2024, no payments subject to the CVR Agreement had Former Rexahn Warrants As of June 30, 2024, none of the Rexahn warrants classified as equity remained outstanding. The remaining warrants in the amount of 58,597 with an exercise price of $38.40 per share expired unexercised in January 2024. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024, there was sufficient uncertainty with regard to any future cash milestone payments under the sublicense agreement that no liabilities were recorded related to the sublicense agreement. Facility Leases The Company has a short-term, non-cancellable facility lease (the “HQ Lease”) for its headquarters. The HQ Lease qualified for the short-term lease exception under ASC 842, Leases 3,000 18,000 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 and patent infringement, employment 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 effect on its results of operations or financial position. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 6 Months Ended |
Jun. 30, 2024 | |
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): June 30, 2024 December 31, 2023 Prepaids $ 1,027 $ 997 Other 87 102 Total prepaids and other assets $ 1,114 $ 1,099 Property and Equipment, net Property and equipment held for use by category are presented in the following table (in thousands): June 30, 2024 December 31, 2023 Equipment 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (25 ) (25 ) Property and equipment, net $ — $ — Depreciation expense was $1,000 and $2,000 during three and six months ended June 30, 2023, respectively. There was no depreciation expense during both the three and six months ended June 30, 2024. Accrued Expenses Accrued expenses consist of the following (in thousands): June 30, December 31, 2024 2023 Payroll $ 427 $ 753 Professional services 1,427 591 Research and development services and supplies 1,540 400 Other 96 71 Total $ 3,490 $ 1,815 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions On April 8, 2022, Ocuphire entered into a consulting agreement (as amended, the “2022 Consulting Agreement”) with Jay Pepose, M.D., a director of the Company. The consulting agreement originally provided for $ 10,000 50,000 On April 19, 2023, Ocuphire appointed Richard Rodgers, a director of the Company, as interim President and Chief Executive Officer. In connection with his appointment, Ocuphire and Mr. Rodgers entered into a letter agreement, dated as of April 20, 2023, concerning Mr. Rodgers’s services (the “Letter Agreement”). The Letter Agreement provided that Mr. Rodgers (i) was to receive a $40,000 monthly salary, and (ii) was eligible for a potential prorated bonus at the discretion of Ocuphire’s Board of Directors, at the end of his term as interim President and Chief Executive Officer. Pursuant to the bonus clause, a $100,000 bonus was expensed in December 2024 and paid on March 4, 2024. of related consulting expenses As Mr. Rogers’s services as interim President and Chief Executive Officer concluded on October 31, 2023 with the appointment of George Magrath to the role, the Letter Agreement has expired, and the Company does not expect to incur further expenses related thereto. On April 11, 2024, the Company entered into another consulting agreement (the “2024 Consulting Agreement”) with Dr. Pepose, pursuant to which Dr. Pepose agreed to continue to serve as a consultant of the Company following the expiration of the 2022 Consulting Agreement. Pursuant to the 2024 Consulting Agreement, Dr. Pepose is paid a monthly consulting fee of $39,583. Additionally, Dr. Pepose received an award of 32,000 RSUs, as well as stock options to purchase 48,000 shares of the Company’s common stock. The RSUs awarded under the 2024 Consulting Agreement will vest on April 11, 2025, subject to Dr. Pepose’s continued service over that period. The options granted under the 2024 Consulting Agreement vest in 12 equal monthly installments beginning on May 11, 2024, subject to Dr. Pepose’s continued service over such period. The 2024 Consulting Agreement is scheduled to terminate on April 11, 2025. For the agreements with Dr. Pepose above, the |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 6. S tockholders’ Equity Amendment to Articles of Incorporation At the Company’s 2024 annual meeting of stockholders held on June 11, 2024, the Company’s stockholders voted to approve an amendment to the Company’s Amended and Restated Certificate of Incorporation that resulted in an increase in the number of authorized shares of the Company’s common stock from 75 million to 125 million shares. The increase in authorized shares became effective on June 12, 2024. Lincoln Park Purchase Agreement On August 10, 2023, the Company entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) for an equity line financing (the “Purchase Agreement”). The Purchase Agreement provides that, subject to the terms and conditions set forth therein, the Company has the sole right, but not the obligation, to direct Lincoln Park to purchase up to $50 million of shares of the Company’s common stock from time to time over the 30-month term of the Purchase Agreement. Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which the Company agreed to register the resale of the shares of the Company’s common stock that have been and may be issued to Lincoln Park under the Purchase Agreement pursuant to a registration statement. Lincoln Park has agreed not to cause or engage in any manner whatsoever in any direct or indirect short selling or hedging of the Company’s common stock. In addition to the commitment shares referenced above, a total of 250,000 shares and 400,000 shares were issued under the Purchase Agreement during the three and six months ended June 30, 2024, respectively, for net proceeds of $0.5 million and $0.7 million, respectively. The Company incurred de minimis Under the Purchase Agreement, on any business day selected by the Company, the Company may direct Lincoln Park to purchase up to 50,000 shares of its common stock on such business day (or the purchase date) (a “Regular Purchase”), provided that the closing sale price of the Company’s common stock on Nasdaq on the applicable purchase date is not below $0.25 and subject to other adjustments. A Regular Purchase may be increased to up to (i) 60,000 shares if the closing sale price of the Company’s common stock on Nasdaq is not below $5.00 on the applicable purchase date and (ii) 70,000 shares if the closing sale price of the Company’s common stock on Nasdaq is not below $7.50 on the applicable purchase date. The Company may direct Lincoln Park to purchase shares in Regular Purchases as often as every business day. The purchase price per share for each such Regular Purchase will be equal to the lesser of: • the lowest sale price for the Company’s common stock on Nasdaq on the purchase date of such shares; and • the average of the three lowest closing sale prices for the Company’s common stock on Nasdaq during the ten In addition, the Company may also direct Lincoln Park, on any business day on which the Company has submitted a Regular Purchase notice for the maximum amount allowed for such Regular Purchase, to purchase an additional amount of the Company’s common stock (an “Accelerated Purchase”) of up to the lesser of: • three times the number of shares purchased pursuant to such Regular Purchase; and • 30% of the aggregate shares of the Company’s common stock traded on Nasdaq during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed (the “Accelerated Purchase Measurement Period”). The purchase price per share for each such Accelerated Purchase will be equal to 96.5% of the lower of: • the closing sale price of the Company’s common stock on Nasdaq on the applicable Accelerated Purchase date; and • the volume-weighted average price of the Company’s common stock on Nasdaq during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date. The Company may also direct Lincoln Park, on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been delivered to Lincoln Park in accordance with the Purchase Agreement, to purchase an additional amount of the Company’s common stock (an “Additional Accelerated Purchase”) as described in the Purchase Agreement. The pricing and settlement provisions in the Purchase Agreement result in the recognition of a derivative liability Derivatives and Hedging de minimis . The fair value change in the derivative liability is recorded in the fair value change in derivative liabilities line item in the accompanying condensed statements of comprehensive loss during periods with valuation changes. 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 c ommon stock having an aggregate offering price of up to $40 million (the “2021 ATM”). During the three and six months ended June 30, 2024, 538,566 and 1,389,116 shares of common stock were sold under the ATM, respectively, for aggregate gross proceeds in the amount of $1.1 million and $3.3 million, respectively, respectively. A total of 7,434,432 shares of common stock were sold under the ATM since its inception for gross proceeds through June 30, 2024 in the amount of $26.0 million and with issuance costs in the aggregate of $0.9 million. [See Note 13 – Subsequent Events.] Registered Direct Offering On June 4, 2021, the Company entered into a placement agency agreement for a registered direct offering (“RDO”) with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the placement agency agreement, AGP on June 8, 2021 sold an aggregate of 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”) at an offering price of $4.875 per one share and per one-half 2021 shelf registration. The RDO Warrants have an exercise price of $6.09 per share, are exercisable from the initial issuance date of June 8, 2021, and will expire five years following the initial issuance date. As of June Subject to limited exceptions, a holder of a RDO Warrant will not have the right to exercise any portion of its RDO Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise; provided that upon prior notice to the Company, the holder may increase or decrease the beneficial ownership limitation, provided further that in no event shall the beneficial ownership limitation exceed 9.99%. Pre-Merger Financing On June 17, 2020, Ocuphire, Rexahn and certain investors entered into a Securities Purchase Agreement, which was amended and restated in its entirety on June 29, 2020 (as amended and restated, the “Securities Purchase Agreement”). Pursuant to the Securities Purchase Agreement, the investors invested a total of $21.15 million in cash, including $300,000 invested by five directors of Ocuphire Pharma, Inc., prior to the Merger and one director of Rexahn upon closing of the Merger (the “Pre-Merger Financing”). The Pre-Merger Financing also included the issuance of Series A Warrants and Series B Warrants discussed further below. Series A Warrants The Series A Warrants were issued on November 19, 2020 at an initial exercise price of $4.4795 per share, were immediately exercisable upon issuance and have a term of five years from the date of issuance. The Series A Warrants are exercisable for 5,665,838 shares of common stock in the aggregate (without giving effect to any limitation on exercise contained therein) and were outstanding as of June 30, 2024. The Series A Warrants were accounted for and classified as equity on the accompanying balance sheets. Series B Warrants The Series B Warrants had an exercise price of $0.0001, were exercisable upon issuance and would have expired on the day following the later to occur of (i) the Reservation Date (as defined therein) or (ii) the date on which the investor’s Series B Warrants would have been exercised in full (without giving effect to any limitation on exercise contained therein). None of the Series B Warrants were outstanding as of June 30, 2024 or June 30, 2023. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
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 los s for the three and six-month periods indicate Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 General and administrative $ 526 $ 1,166 $ 1,301 $ 1,634 Research and development 280 256 490 592 Total stock-based compensation $ 806 $ 1,422 $ 1,791 $ 2,226 Inducement Plan On February 22, 2021, the Company adopted the Ocuphire Pharma, Inc. 2021 Inducement Plan (as amended, the “Inducement Plan”), which was amended on November 1, 2023, pursuant to which the Company reserved 2,325,258 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. 2020 Equity Incentive Plan In November 2020, the stockholders of the Company approved the 2020 Equity Incentive Plan (the “2020 Plan”) for stock-based awards. Under the 2020 Plan, (i) 1,000,000 new shares of common stock were reserved for issuance and (ii) up to 70,325 additional shares of common stock may be issued, consisting of (A) shares that remain available for the issuance of awards under prior equity plans and (B) shares of common stock subject to outstanding stock options or other awards covered by prior equity plans that have been cancelled or expire on or after the date that the 2020 Plan became effective. Under the 2020 Plan, the shares reserved automatically increase on January 1 of each year, for a period of not more than ten years from the date the 2020 Plan is approved by the stockholders of the Company, commencing on January 1, 2021 and ending on (and including) January 1, 2030, by an amount equal to 5% of the shares of common stock outstanding as of December 31 of the preceding calendar year. The 2020 Plan permits the granting of incentive and nonstatutory stock options, appreciation rights, restricted stock, restricted stock units, performance stock and cash awards, and other stock-based awards. On January 1, 2024, 1,198,875 shares were added to the 2020 Plan as a result of its evergreen provision. 2018 Equity Incentive Plan Prior to the 2020 Plan, the Company had adopted a 2018 Equity Incentive Plan (the “2018 Plan”) in April 2018 under which 1,175,000 shares of the Company’s common stock were reserved for issuance to employees, directors and consultants. Upon the effective date of the 2020 Plan, no additional shares were available for issuance under the 2018 Plan. Stock Options During the three and six months ended June 30, 2024, 259,086 and 1,021,166 stock options were granted, respectively, to directors, officers, employees and consultants, one During the three and six months ended June 30, 2023, 98,195 and 763,578 stock options were granted, respectively, to directors, officers, employees and consultants, generally vesting over a five- (5) to forty-eight (48) month period. The . There were no stock option exercises during the three and six months ended June 30, 2024 and 2023. As of June 30, 2024 and December 31, 2023, 4,962,489 and 4,410,258 stock options were outstanding, respectively. The weighted average fair value per share of options granted during the three and six months ended June 30, 2024 was $1.35 and $1.95, respectively. The weighted average fair value per share of options granted during the three and six months ended June 30, 2023 was $3.36 and $2.83, 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 and six months ended June 30, 2024 and 2023: Three Months Ended June 30, Six Months 2024 2023 2024 2023 Expected stock price volatility 98.3 % 94.4 % 97.7 % 95.3 % Expected life of options (years) 5.5 5.8 5.9 6.1 Expected dividend yield — % — % — % — % Risk free interest rate 4.4 % 3.7 % 4.2 % 3.7 % During During the three and six months ended June 30, 2024, 124,030 and 468,935 options were forfeited, respectively. During the three and six months ended June 30, 2023, 254,966 Restricted Stock Units During the three and six months ended June 30, 2024, the Company granted an aggregate of 278,858 and 592,222 restricted stock units (“RSUs”), respectively, to the board of directors and certain officers, employees and consultants under the 2020 Plan. The weighted average grant date per unit fair value of the RSUs granted during the three and six months ended June 30, 2024 was $1.73 and $2.24, respectively. The vesting period of the RSUs range from a one-year period to a four-year period during which 25 percent of the RSUs vest annually on each anniversary of the grant date, subject to the recipient’s continued service on such dates. During the three and six months ended June 30, 2023, the Company granted an aggregate of 124,880 and 416,464 RSUs, respectively, to the board of directors and certain officers and employees under the 2020 Plan. The weighted average grant date per unit fair value of the RSUs granted during the three and six months ended June 30, 2023 was $5.09 and $3.98, respectively. The vesting period of the RSUs range from a one-year period to a four-year period during which 25 percent of the RSUs vest annually on each anniversary of the grant date, subject to the recipient’s continued service on such dates. During the three and six months ended June 30, 2024, 104,880 and 144,162 RSUs vested, respectively, and zero and 82,670 RSUs were forfeited during the three and six months ended June 30, 2024, respectively. During the three and six months ended June 30, 2023, 33,614 RSUs vested and 100,842 RSUs were forfeited, both attributed solely to the departure of Mina Sooch, the Company’s former Chief Executive Officer. The total expense for the three and six months ended June 30, 2024 related to these RSUs was $296,000 and $589,000, respectively. The total expense for the three and six months ended June 30, 2023 related to these RSUs was $208,000 and $265,000, respectively . Common Stock Issued for Services The Company granted stock for services in the amount of 81,234 common shares during the six months ended June 30, 2024 to board members who elected to receive their board retainers in the form of stock for services with a grant date fair value of $3.01 per share. The Company granted stock for services in the amount of 4,340 and 72,986 common shares during the three and six months ended June 30, 2023, respectively, to board members who elected to receive their board retainers in the form of stock for services with a grant date fair value of $6.38 and $3.77 per share, respectively. The stock-based compensation related to these services amounted to zero and $28,000 during the three months ended June 30, 2024 and 2023, respectively, and $245,000 and $275,000 during the six months ended June 30, 2024 and 2023, respectively. General As of June 30, 2024, 1,596,826 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 $7.3 million as of June 30, 2024. The unrecognized stock-based expense is expected to be recognized over a weighted average period of 1.75 years. |
Apexian Sublicense Agreement
Apexian Sublicense Agreement | 6 Months Ended |
Jun. 30, 2024 | |
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 may develop as an oral tablet therapeutic to treat diabetic retinopathy initially, and potentially later to treat diabetic macular edema, geographic atrophy and age-related macular degeneration. In connection with the Apexian Sublicense Agreement, the Company issued a total of 891,422 shares of its common stock to Apexian and to certain affiliates of Apexian in calendar year 2020. As a result of the common stock issued pursuant to the Apexian Sublicense Agreement, Apexian is considered by Ocuphire to be a related party. The Company also agreed to make one-time milestone payments under the Apexian Sublicense Agreement for each of the first ophthalmic indication and the first diabetes mellitus indication for the development and regulatory milestones, and once for each of several sales milestones. These milestone payments include (i) payments for specified developmental and regulatory milestones (including completion of the first Phase 2 trial and the first Phase 3 pivotal trial in the United States, and filing and achieving regulatory approval from the FDA for the first New Drug Application for a compound) totaling up to $11 million in the aggregate and (ii) payments for specified sales milestones of up to $20 million in the aggregate, which net sales milestone payments are payable once, upon the first achievement of such milestone. Lastly, the Company also agreed to make a royalty payment equal to a single-digit percentage of its net sales of products associated with the covered patents under the Apexian Sublicense Agreement. If it is not terminated pursuant to its terms, the Apexian Sublicense Agreement shall remain in effect until expiration of the last to expire of the covered patents. None of the milestone or royalty payments were triggered or deemed probable as of June 30, 2024 . |
License and Collaboration Agree
License and Collaboration Agreements | 6 Months Ended |
Jun. 30, 2024 | |
License and Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 9. License and Collaboration Agreements Viatris License Agreement On November 6, 2022, the Company entered into the Viatris License Agreement, pursuant to which it granted Viatris (as successor to Famy) an exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize (i) PS, for treating (a) reversal of mydriasis, (b) night vision disturbances or dim light vision, and (c) presbyopia, and (ii) PS and low dose pilocarpine for treating presbyopia (together, the “PS Products”) worldwide except for certain countries and jurisdictions in Asia (the “Viatris Territory”). The Company retains the exclusive right to develop, manufacture, have manufactured, import, export and commercialize the PS Products outside of the Viatris Territory. Pursuant to the Viatris License Agreement, the Company received a one-time non-refundable cash payment of $35 million in November 2022 for the exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize the PS Products in the Viatris Territory. In addition, with respect to the PS Products, the Company will be eligible to receive potential additional payments of up to $130 million in the aggregate upon achieving certain specified regulatory or net sales milestones, with the first milestone payment of $10 million already made following approval by the FDA of PS for reversal of mydriasis, which occurred during the third quarter of 2023. The Company will also receive tiered royalties, starting at low double-digit royalties up to low 20% royalties, based on the aggregate annual net sales of all PS Products in the United States, and will receive low double-digit royalties based on all annual net sales in the Viatris Territory outside of the United States. The royalty payments will continue on a country-by-country basis from the date of the first commercial sale of the first PS Product in a country of the Viatris Territory until December 31, 2040. The Viatris 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 Company determined that the licenses transferred represented functional intellectual property. As such, the revenue related to the licenses was recognized at the point in time in which the license/know-how was delivered to Viatris which occurred during the fourth quarter of 2022. The Company determined that revenue related to the research and development services constrained to the 120-day non-cancellation period was to be recognized over time as the services are rendered based on an estimated percentage of completion input model. Recognition of Revenue Revenue recognized under the Viatris License Agreement during the three and six months ended June 30, 2024 was $1.1 million and $2.8 million, respectively. Viatris License Agreement Regulatory Milestones under the Viatris License Agreement The Company has evaluated the regulatory milestones that may be received in connection with the Viatris License Agreement. There is uncertainty that the events to obtain the remaining regulatory milestones (aside from the approval by the FDA of PS, for reversal of mydriasis) will be achieved given the nature of clinical development and the stage of the development of the PS Products. These remaining regulatory milestones will be constrained until it is probable that a significant revenue reversal will not occur. Sales Milestone and Royalty Payments Sales milestones and royalties relate predominantly to a license of intellectual property granted to Viatris and are determined by sales or usage-based thresholds. The sales milestones and royalties are accounted for under the royalty recognition constraint and are accounted for as constrained variable consideration. The Company applies the royalty recognition constraint for each commercial milestone and only recognize revenues for each once a sale of a licensed product (achievement of each) occurs. Royalty payments in the amount of $19,000 and $22,000 were recognized related to the sale of RYZUMVI by Viatris during the three and six months ended June 30, 2024, respectively Each of the remaining regulatory and sales milestone performance obligations (aside from the $10 million milestone payment related to the FDA’s approval of PS in the third quarter of 2023) were constrained as of June 30, 2024 and no revenue was recognized related to these milestones. A reconciliation of the closing balance of the contract assets and unbilled receivables associated with the Viatris License Agreement is as follows as of June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Contract Assets and Unbilled Receivables Balance as of beginning of six-month period $ 1,407 $ 3,552 Revenue recognized 2,823 5,423 Reclassification to accounts receivable related to costs billed under the Viatris License Agreement (3,282 ) (6,380 ) Balance as of end of six-month period $ 948 $ 2,595 The remaining amounts in contract assets and unbilled receivables as of June 30, 2024 attributed to the research and development services are expected to be settled during the third quarter of 2024. BioSense License and Assignment Agreement On March 10, 2020, prior to the Merger, Rexahn entered into an amendment to its collaboration and license agreement, (as amended, the “BioSense License and Assignment Agreement”) with BioSense to advance the development and commercialization of the Rexahn RX-3117 drug compound (“RX-3117”) for all human uses in the Republic of Singapore, China, Hong Kong, Macau, and Taiwan (the “BioSense Territory”). 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 no 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 agreed to grant Processa an exclusive license to develop, manufacture and commercialize RX-3117 globally, excluding the BioSense Territory. Processa will make future payments to the Company upon the achievement of certain development and regulatory milestones, which primarily consist of dosing a patient in pivotal trials or having a drug indication approved by a regulatory authority in the United States or another country. In addition, Processa will pay the Company mid-single-digit percentage royalties based on annual sales under the license and will make one 32% no 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 | 6 Months Ended |
Jun. 30, 2024 | |
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 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 and six-month periods presented below: June 30, 2024 2023 Series A and RDO warrants 7,204,299 7,204,299 Stock options 4,962,489 3,444,656 RSUs 1,167,090 282,008 Former Rexahn warrants — 58,597 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Taxes [Abstract] | |
Income Taxes | 11. Income Taxes The effective tax rate for the three and six months ended June 30, 2024 and 2023 was zero percent. As of June 30, 2024, 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 2020 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 | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30 , 2024 and 2023, the Company contributed $43,000 and $22,000 to the 401 K Plan, respectively. During the six months ended June 30, 2024 and 2023, the Company contributed $101,000 and $56,000 to the 401K Plan, respectively . |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events Subsequent to June 30, 2024, 219,406 shares of common stock were sold under the ATM for gross proceeds through August 7, 2024 in the amount of $.5 million, before deducting issuance expenses, including the placement agent’s fees and legal and accounting expenses, in the amount of $11,000. |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Company Description and Summa_2
Company Description and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | |
Nature of Business | Nature of Business Ocuphire Pharma, Inc. (the “Company” or “Ocuphire”) is a clinical-stage biopharmaceutical company with one FDA-approved product currently marketed by Viatris, Inc. (“Viatris”), our development and commercial partner. The Company’s lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1α and NF-kB. Inhibiting Ref-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet intended to be administered twice per day in development for the treatment of diabetic retinopathy (“DR”). A Phase 2 study in subjects with DR or diabetic macular edema was completed and results were reported in January 2023. An End-of-Phase 2 (“EOP2”) meeting with the U.S. Food and Drug Administration (the “FDA”) was held in October 2023 at which the Company obtained agreement on the registration efficacy endpoint for APX3330 in future clinical trials. Ocuphire submitted a Special Protocol Assessment (“SPA”) to the FDA in February 2024 to seek agreement on the clinical trial protocol and statistical analysis plan. The company continues dialog with the FDA and will update the market upon conclusion of these discussions. The Company has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique mechanism of action of this family of Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration, geographic atrophy, and non-ophthalmic diseases. In November 2022, the Company entered into a license and collaboration agreement (the “Viatris License Agreement”) with FamyGen Life Sciences, Inc. (acquired by and now known as Viatris, Inc. (“Viatris”)), 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% (initially known as Nyxol) (“PS”). PS is a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity. PS was approved by the FDA for the treatment for pharmacologically induced mydriasis under the brand name RYZUMVI TM The Company reported positive top-line data from multiple late-stage clinical trials for PS in reversal of pharmacologically induced mydriasis, presbyopia and dim light disturbances. The VEGA-2 Phase 3 study in presbyopia achieved its primary endpoint. The VEGA-3 Phase 3 clinical trial evaluating PS for presbyopia (age-related blurry near vision) has begun recruiting. For decreased vision under mesopic (low) light conditions following keratorefractive surgery, we received FDA agreement under Special Protocol Assessment for LYNX-2, a Phase 3 Trial of PS. The first patient was enrolled in LYNX-2 in April 2024. |
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, 2023 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, 2023. 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. |
Liquidity | Liquidity The accompanying financial statements have been prepared on the basis that the Company will continue as a going concern. From its inception, the Company has devoted substantially all its efforts to drug development and conducting clinical trials. As of June 30, 2024, the Company had $41.4 million in cash and cash equivalents. The Company believes its current available cash and cash equivalents will be sufficient to fund the Company’s planned expenditures and meet its obligations for at least twelve months from the date of issuance of these financial statements. In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or pursue additional financing, may provide additional liquidity in the future; however, these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions taken to generate the liquidity ultimately required. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Segment Information | Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer or such person functioning in such role. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development of products related to vision performance and health. Accordingly, the Company has a single reporting segment. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of deposit to be cash equivalents. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. Management follows approved policies established by its Board of Directors to reduce credit risk associated with the Company’s cash deposit and investment accounts. Pursuant to these policies, the Company limits its exposure through the kind, quality and concentration of its investments. The Company’s cash and cash equivalents are held or managed by two financial institutions in the United States. . These balances are invested in funds whose assets consist almost entirely of securities issued by the U.S. Treasury or guaranteed by the U.S. government . |
Short-term Investments | Short-term Investments The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and records them on a settlement date basis. The Company’s short-term investments are comprised of equity securities, which in accordance with the fair value hierarchy described below are recorded at fair value using Level l inputs on the balance sheets. Subsequent changes in fair values are recorded in other income, net on the 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 June 30, 2024. |
Revenue Recognition | Revenue Recognition The Company follows the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers 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 Assets and Unbilled Receivables | Contract Assets and Unbilled Receivables The Company recognizes contract assets and unbilled receivables when goods or services are transferred to the customer before the customer pays or before reimbursement for payment is billed or due, excluding any amounts presented as an account receivable. The Company recorded contract assets and unbilled receivables in connection with a license and collaboration agreement (See Note 9 – License and Collaboration Agreements). |
Accounts Receivable and Allowances for Credit Losses | Accounts Receivable and Allowances for Credit Losses The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. The Company estimates credit losses over the remaining expected life of an asset by, among other things, primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance. The Company has not incurred any bad debt expense to date and no allowance for credit losses has been recorded during the periods presented. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include insurance coverage for directors and officers and other property and liability exposures, legal fees relating to intellectual property and corporate matters, professional fees for accounting and tax services, other services provided by business consultants, and legal settlements. |
Research and Development | Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including compensation, benefits and stock-based compensation costs for research and development employees and costs for consultants, costs associated with nonclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses. Research and development expenses include costs that are reimbursed under the Viatris License Agreement (See Note 9 – License and Collaboration Agreements). |
Other Income, net | Other Income, net Other income, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in connection with grants and other sources when they oc cur. In addition, this line item includes payments made by the Company in connection with the Contingent Value Rights Agreement discussed further below with former shareholders of . |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of the Financial Accounting Standards Board (“FASB”) ASC 718, Compensation — Stock Compensation. |
Derivative Liability | Derivative Liability The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separation from the underlying agreement under ASC 815 – Derivatives and Hedging |
Fair Value Measurements | Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy: • Level 1 inputs: Unadjusted quoted prices for identical assets or liabilities in active markets; • Level 2 inputs: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and • Level 3 inputs: Unobservable inputs in which there is little or no market data available, which requires management to develop its own assumptions in pricing the asset or liability. As of June 30, 2024 and December 31, 2023, the fair values of cash and cash equivalents, accounts receivable, contract assets and unbilled receivables, prepaid and other assets, accounts payable, and accrued expenses approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the short-term investments, while outstanding, were based on observable Level 1 inputs in the form of quoted market prices from a major stock exchange. The fair value of the derivative liability associated with the equity line financing facility (See Note 6 – Stockholders’ Equity) was based on cash flow models discounted at current implied market rates representing expected returns by market participants for similar instruments and are based on Level 3 inputs as well the Company’s underlying stock price and associated volatility, expected term of the financing and market interest rates. 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 and six months ended June 30, 2024 and 2023. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of June 30, 2024 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 5 $ 5 $ — $ — Total assets at fair value $ 5 $ 5 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 As of December 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 15 $ 15 $ — $ — Total assets at fair value $ 15 $ 15 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 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 six months ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Short-term investments Balance as of beginning of period $ 15 $ 49 Unrealized loss (10 ) (27 ) Balance as of end of period $ 5 $ 22 The following table provides a roll-forward of the derivative liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the six months ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Derivative liabilities Balance as of beginning of period $ 74 $ — Change in fair value of derivative liabilities — — Balance as of end of period $ 74 $ — |
Rexahn Warrants | Rexahn Warrants The fair value of the warrant liabilities associated with the warrants was de minimis during the periods presented. The last of the Rexahn warrants classified as liabilities expired in April 2023 unexercised. See Note 2 – Merger for additional background. There were no financial instruments measured on a non-recurring basis for any of the periods presented. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Company Description and Summa_3
Company Description and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 5 $ 5 $ — $ — Total assets at fair value $ 5 $ 5 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 As of December 31, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 15 $ 15 $ — $ — Total assets at fair value $ 15 $ 15 $ — $ — Liabilities: Derivative liability $ 74 $ — $ — $ 74 Total liabilities at fair value $ 74 $ — $ — $ 74 |
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 six months ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Short-term investments Balance as of beginning of period $ 15 $ 49 Unrealized loss (10 ) (27 ) Balance as of end of period $ 5 $ 22 |
Derivative Liabilities Measured at Fair Value on a Recurring Basis | The following table provides a roll-forward of the derivative liabilities measured at fair value on a recurring basis using unobservable level 3 inputs for the six months ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Derivative liabilities Balance as of beginning of period $ 74 $ — Change in fair value of derivative liabilities — — Balance as of end of period $ 74 $ — |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Supplemental Balance Sheet Information [Abstract] | |
Prepaid and Other Assets | Prepaid and other assets consist of the following (in thousands): June 30, 2024 December 31, 2023 Prepaids $ 1,027 $ 997 Other 87 102 Total prepaids and other assets $ 1,114 $ 1,099 |
Property and Equipment, Net | Property and equipment held for use by category are presented in the following table (in thousands): June 30, 2024 December 31, 2023 Equipment 20 $ 20 Furniture 5 5 Total property and equipment 25 25 Less accumulated depreciation (25 ) (25 ) Property and equipment, net $ — $ — |
Accrued Expenses | Accrued expenses consist of the following (in thousands): June 30, December 31, 2024 2023 Payroll $ 427 $ 753 Professional services 1,427 591 Research and development services and supplies 1,540 400 Other 96 71 Total $ 3,490 $ 1,815 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 los s for the three and six-month periods indicate Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 General and administrative $ 526 $ 1,166 $ 1,301 $ 1,634 Research and development 280 256 490 592 Total stock-based compensation $ 806 $ 1,422 $ 1,791 $ 2,226 |
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 and six months ended June 30, 2024 and 2023: Three Months Ended June 30, Six Months 2024 2023 2024 2023 Expected stock price volatility 98.3 % 94.4 % 97.7 % 95.3 % Expected life of options (years) 5.5 5.8 5.9 6.1 Expected dividend yield — % — % — % — % Risk free interest rate 4.4 % 3.7 % 4.2 % 3.7 % |
License and Collaboration Agr_2
License and Collaboration Agreements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
License and Collaboration Agreements [Abstract] | |
Reconciliation of Contract Asset assets and Unbilled Receivables | A reconciliation of the closing balance of the contract assets and unbilled receivables associated with the Viatris License Agreement is as follows as of June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Contract Assets and Unbilled Receivables Balance as of beginning of six-month period $ 1,407 $ 3,552 Revenue recognized 2,823 5,423 Reclassification to accounts receivable related to costs billed under the Viatris License Agreement (3,282 ) (6,380 ) Balance as of end of six-month period $ 948 $ 2,595 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 and six-month periods presented below: June 30, 2024 2023 Series A and RDO warrants 7,204,299 7,204,299 Stock options 4,962,489 3,444,656 RSUs 1,167,090 282,008 Former Rexahn warrants — 58,597 |
Company Description and Summa_4
Company Description and Summary of Significant Accounting Policies, Nature of Business (Details) | 6 Months Ended |
Jun. 30, 2024 Product | |
Nature of Business [Abstract] | |
Number of FDA approved product | 1 |
Company Description and Summa_5
Company Description and Summary of Significant Accounting Policies, Liquidity (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Liquidity [Abstract] | ||
Cash and cash equivalents | $ 41,409 | $ 50,501 |
Company Description and Summa_6
Company Description and Summary of Significant Accounting Policies, Segment Information (Details) | 6 Months Ended |
Jun. 30, 2024 Segment | |
Segment Information [Abstract] | |
Number of operating segments | 1 |
Company Description and Summa_7
Company Description and Summary of Significant Accounting Policies, Concentration of Credit Risk (Details) $ in Millions | Jun. 30, 2024 USD ($) |
Concentration of Credit Risk [Abstract] | |
Cash equivalents not eligible for coverage | $ 40.9 |
Company Description and Summa_8
Company Description and Summary of Significant Accounting Policies, Short-term Investments (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Other than Temporary Impairment Losses, Investments [Abstract] | |
Impairment on investments | $ 0 |
Company Description and Summa_9
Company Description and Summary of Significant Accounting Policies, Accounts Receivable and Allowances for Credit Losses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2024 | Dec. 31, 2023 | |
Accounts Receivable and Allowances for Credit Losses [Abstract] | ||
Bad debt expense | $ 0 | |
Allowance for credit losses | $ 0 | $ 0 |
Company Description and Summ_10
Company Description and Summary of Significant Accounting Policies, Fair Value of Financial Instruments Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Company Description and Summary of Significant Accounting Policies [Abstract] | |||||
Transfers in into Level 3 | $ 0 | $ 0 | $ 0 | $ 0 | |
Transfers out of Level 3 | 0 | $ 0 | 0 | $ 0 | |
Recurring Basis [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 5 | 5 | $ 15 | ||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 74 | 74 | 74 | ||
Recurring Basis [Member] | Derivative Liability [Member] | |||||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 74 | 74 | 74 | ||
Recurring Basis [Member] | Short-Term Investments [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 5 | 5 | 15 | ||
Recurring Basis [Member] | Level 1 [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 5 | 5 | 15 | ||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 0 | 0 | 0 | ||
Recurring Basis [Member] | Level 1 [Member] | Derivative Liability [Member] | |||||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 0 | 0 | 0 | ||
Recurring Basis [Member] | Level 1 [Member] | Short-Term Investments [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 5 | 5 | 15 | ||
Recurring Basis [Member] | Level 2 [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 0 | 0 | 0 | ||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 0 | 0 | 0 | ||
Recurring Basis [Member] | Level 2 [Member] | Derivative Liability [Member] | |||||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 0 | 0 | 0 | ||
Recurring Basis [Member] | Level 2 [Member] | Short-Term Investments [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 0 | 0 | 0 | ||
Recurring Basis [Member] | Level 3 [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | 0 | 0 | 0 | ||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 74 | 74 | 74 | ||
Recurring Basis [Member] | Level 3 [Member] | Derivative Liability [Member] | |||||
Liabilities [Abstract] | |||||
Total liabilities at fair value | 74 | 74 | 74 | ||
Recurring Basis [Member] | Level 3 [Member] | Short-Term Investments [Member] | |||||
Assets [Abstract] | |||||
Assets at fair value | $ 0 | $ 0 | $ 0 |
Company Description and Summ_11
Company Description and Summary of Significant Accounting Policies, Equity Investments Measured at Fair Value (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Equity Investments [Abstract] | ||
Unrealized loss | $ (10) | $ (27) |
Recurring Basis [Member] | Level 1 [Member] | Short-Term Investments [Member] | ||
Equity Investments [Abstract] | ||
Balance as of beginning of period | 15 | 49 |
Unrealized loss | (10) | (27) |
Balance as of end of period | $ 5 | $ 22 |
Company Description and Summ_12
Company Description and Summary of Significant Accounting Policies, Derivative Liabilities Measured at Fair Value (Details) - Level 3 [Member] - Derivative Liabilities [Member] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance as of beginning of period | $ 74 | $ 0 |
Change in fair value of derivative liabilities | 0 | 0 |
Balance as of end of period | $ 74 | $ 0 |
Company Description and Summ_13
Company Description and Summary of Significant Accounting Policies, Rexahn Warrants (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Nonrecurring [Member] | ||
Financial Liabilities Fair Value Disclosure [Abstract] | ||
Financial instruments liabilities at fair value | $ 0 | $ 0 |
Merger, Contingent Value Rights
Merger, Contingent Value Rights Agreement (Details) | 6 Months Ended | |||
Jun. 30, 2024 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 | Jun. 30, 2024 | Jan. 31, 2024 |
Former Rexahn Warrants [Abstract] | ||
Number of warrants outstanding (in shares) | 0 | 58,597 |
Exercise price (in dollars per share) | $ 38.4 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Facility Lease [Abstract] | ||||
Monthly base rent | $ 3,000 | |||
Rent expense | $ 9,000 | $ 9,000 | 18,000 | $ 18,000 |
Expected rent payment for the year end 2024 | $ 18,000 | $ 18,000 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information, Prepaid and Other Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaid and Other Assets [Abstract] | ||
Prepaids | $ 1,027 | $ 997 |
Other | 87 | 102 |
Total prepaids and other assets | $ 1,114 | $ 1,099 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information, Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Property and Equipment, Net [Abstract] | |||||
Total property and equipment | $ 25 | $ 25 | $ 25 | ||
Less accumulated depreciation | (25) | (25) | (25) | ||
Property and equipment, net | 0 | 0 | 0 | ||
Depreciation expense | 0 | $ 1 | 0 | $ 2 | |
Equipment [Member] | |||||
Property and Equipment, Net [Abstract] | |||||
Total property and equipment | 20 | 20 | 20 | ||
Furniture [Member] | |||||
Property and Equipment, Net [Abstract] | |||||
Total property and equipment | $ 5 | $ 5 | $ 5 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information, Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Expenses [Abstract] | ||
Payroll | $ 427 | $ 753 |
Professional services | 1,427 | 591 |
Research and development services and supplies | 1,540 | 400 |
Other | 96 | 71 |
Total | $ 3,490 | $ 1,815 |
Related Party Transactions (Det
Related Party Transactions (Details) | 3 Months Ended | 6 Months Ended | ||||||||||
May 11, 2024 Intallment | Apr. 11, 2024 USD ($) shares | Mar. 04, 2024 USD ($) | Apr. 19, 2023 USD ($) shares | Apr. 08, 2022 USD ($) shares | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) shares | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Dec. 01, 2022 USD ($) | |
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Restricted stock units (in shares) | shares | 4,340 | 81,234 | 72,986 | |||||||||
Letter Agreement [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Monthly salary | $ | $ 40,000 | |||||||||||
Letter Agreement [Member] | 2020 Equity Incentive Plan [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Vesting period | 12 months | |||||||||||
Restricted stock units (in shares) | shares | 50,000 | |||||||||||
Jay Pepose [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Consulting fee payable in cash | $ | $ 39,583 | $ 10,000 | $ 49,000 | $ 25,000 | ||||||||
Number of stock option granted (in shares) | shares | 50,000 | |||||||||||
Vesting period | 36 months | |||||||||||
Number of equal installments for vesting | Intallment | 12 | |||||||||||
Consulting expenses | $ | $ 119,000 | $ 75,000 | $ 218,000 | $ 150,000 | ||||||||
Consulting expenses unpaid | $ | $ 40,000 | $ 40,000 | $ 25,000 | |||||||||
Jay Pepose [Member] | Vested on March 31, 2023 [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Vesting percentage | 25% | |||||||||||
Richard Rodgers [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Consulting expenses | $ | $ 95,000 | $ 0 | $ 95,000 | |||||||||
Payment for bonuses | $ | $ 100,000 | |||||||||||
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Vesting period | 1 year | |||||||||||
Granted (in shares) | shares | 278,858 | 124,880 | 592,222 | 416,464 | ||||||||
Restricted Stock Units [Member] | Vested on March 31, 2023 [Member] | 2020 Equity Incentive Plan [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Vesting percentage | 25% | 25% | ||||||||||
Restricted Stock Units [Member] | Jay Pepose [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Granted (in shares) | shares | 32,000 | |||||||||||
Stock Options [Member] | Jay Pepose [Member] | ||||||||||||
Pre-Merger Financing and Waiver Agreements [Abstract] | ||||||||||||
Granted (in shares) | shares | 48,000 |
Stockholders' Equity, Amendment
Stockholders' Equity, Amendment to Articles of Incorporation (Details) - shares | Jun. 30, 2024 | Jun. 12, 2024 | Jun. 11, 2024 | Dec. 31, 2023 |
Amendment to Articles of Incorporation [Abstract] | ||||
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 | 75,000,000 | 75,000,000 |
Stockholders' Equity, Lincoln P
Stockholders' Equity, Lincoln Park Purchase Agreement (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 11 Months Ended | ||||
Aug. 10, 2023 USD ($) $ / shares shares | Aug. 10, 2023 USD ($) Time $ / shares shares | Jun. 30, 2024 USD ($) shares | Sep. 30, 2023 shares | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | |
Lincoln Park Purchase Agreement [Abstract] | |||||||
Net proceeds from issuance of shares under Purchase Agreement | $ 4,041 | $ 0 | |||||
Issuance costs | $ 83 | $ 0 | |||||
Lincoln Park [Member] | |||||||
Lincoln Park Purchase Agreement [Abstract] | |||||||
Common stock purchase agreement, term | 30 months | ||||||
Common stock shares issued under Purchase Agreement (in shares) | shares | 246,792 | 250,000 | 0 | 400,000 | 1,700,000 | ||
Net proceeds from issuance of shares under Purchase Agreement | $ 500 | $ 700 | $ 5,200 | ||||
Issuance costs | $ 1,400 | ||||||
Number of consecutive trading days | 10 days | ||||||
Number of time shares purchased | Time | 3 | ||||||
Percentage of common stock | 30% | ||||||
Percentage of accelerated purchase | 96.50% | ||||||
Lincoln Park [Member] | Maximum [Member] | |||||||
Lincoln Park Purchase Agreement [Abstract] | |||||||
Maximum amount purchasable under common stock purchase agreement | $ 50,000 | $ 50,000 | |||||
Number of Shares to be Purchased Under Purchase Agreement Subject to First Pricing Parameter | shares | 50,000 | 50,000 | |||||
Number of Shares to be Purchased Under Purchase Agreement Subject to Second Pricing Parameter | shares | 60,000 | 60,000 | |||||
Number of Shares to be Purchased Under Purchase Agreement Subject to Third Pricing Parameter | shares | 70,000 | 70,000 | |||||
Lincoln Park [Member] | Minimum [Member] | |||||||
Lincoln Park Purchase Agreement [Abstract] | |||||||
Purchase Agreement First Pricing Parameter Price Per Share Price | $ / shares | $ 0.25 | $ 0.25 | |||||
Purchase Agreement Second Pricing Parameter Price Per Share Price | $ / shares | 5 | 5 | |||||
Purchase Agreement Third Pricing Parameter Price Per Share Price | $ / shares | $ 7.5 | $ 7.5 |
Stockholders' Equity, At-The-Ma
Stockholders' Equity, At-The-Market Program (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 40 Months Ended | ||||
Mar. 11, 2021 | Feb. 12, 2021 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | |
At-The-Market Program [Abstract] | |||||||
Proceeds from issuance of common stock in connection with the at-the-market program and purchase agreement | $ 4,041,000 | $ 0 | |||||
Issuance costs | $ 83,000 | $ 0 | |||||
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) | 538,566 | 0 | 1,389,116 | 0 | 7,434,432 | ||
Proceeds from issuance of common stock in connection with the at-the-market program and purchase agreement | $ 1,100,000 | $ 3,300,000 | $ 26,000,000 | ||||
Issuance costs | $ 25,000 | $ 190,000 | $ 900,000 | ||||
ATM [Member] | Maximum [Member] | |||||||
At-The-Market Program [Abstract] | |||||||
Aggregate offering price | $ 40,000,000 |
Stockholders' Equity, Registere
Stockholders' Equity, Registered Direct Offering (Details) - $ / shares | 3 Months Ended | 6 Months Ended | |
Jun. 08, 2021 | Mar. 31, 2023 | Jun. 30, 2024 | |
Common Stock [Member] | |||
Registered Direct Offerings [Abstract] | |||
Warrants exercised (in shares) | 17,869 | ||
Registered Direct Offering [Member] | Warrants [Member] | |||
Registered Direct Offerings [Abstract] | |||
Number of RDO warrants sold at offering price (per unit) | 0.50 | ||
Exercise price (in dollars per share) | $ 6.09 | ||
Expiration period | 5 years | ||
Warrants outstanding (in shares) | 1,538,461 | ||
Warrants exercised (in shares) | 0 | ||
Minimum percentage of beneficial ownership | 4.99% | ||
Maximum percentage of beneficial ownership limitation | 9.99% | ||
Registered Direct Offering [Member] | Common Stock [Member] | |||
Registered Direct Offerings [Abstract] | |||
Shares sold (in shares) | 3,076,923 | ||
Warrants issued (in shares) | 1,538,461 | ||
Offering price (in dollars per share) | $ 4.875 |
Stockholders' Equity, Pre-Merge
Stockholders' Equity, Pre-Merger Financing, Series A & B Warrants (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | ||||
Jun. 29, 2020 USD ($) Director | Jun. 30, 2023 shares | Jun. 30, 2024 $ / shares shares | Jan. 31, 2024 $ / shares shares | Nov. 19, 2020 $ / shares shares | |
Rexahn [Member] | |||||
Pre-Merger Financing [Abstract] | |||||
Exercise price (in dollars per share) | $ / shares | $ 38.4 | ||||
Warrants outstanding (in shares) | 0 | 58,597 | |||
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 | 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 | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation | $ 806 | $ 1,422 | $ 1,791 | $ 2,226 |
General and Administrative [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation | 526 | 1,166 | 1,301 | 1,634 |
Research and Development [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation | $ 280 | $ 256 | $ 490 | $ 592 |
Stock-based Compensation, Sto_2
Stock-based Compensation, Stock Option Plan Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Jan. 01, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Nov. 01, 2023 | Nov. 30, 2020 | Dec. 31, 2019 | |
Stock Options [Abstract] | |||||||||
Stock based compensation | $ 806 | $ 1,422 | $ 1,791 | $ 2,226 | |||||
Inducement Plan [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Common stock reserved for issuance (in shares) | 2,325,258 | ||||||||
2020 Equity Incentive Plan [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Common stock reserved for issuance (in shares) | 1,000,000 | ||||||||
Percentage of common stock shares outstanding | 5% | ||||||||
2020 Equity Incentive Plan [Member] | Minimum [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Vesting period | 1 year | ||||||||
2020 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Common stock reserved for issuance (in shares) | 70,325 | ||||||||
Period of shares reserved under plan | 10 years | ||||||||
Vesting period | 4 years | ||||||||
2018 Equity Incentive Plan [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Common stock reserved for issuance (in shares) | 0 | 0 | 1,175,000 | ||||||
2018 Equity Incentive Plan [Member] | Minimum [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Vesting period | 5 months | ||||||||
2018 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Vesting period | 48 months | ||||||||
2020 Plan Evergreen Provision [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Number of shares added (in shares) | 1,198,875 | ||||||||
Stock Options [Member] | Former Chief Executive Officer [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Stock based compensation | $ 400 | ||||||||
Stock Options [Member] | 2018 Equity Incentive Plan [Member] | |||||||||
Stock Options [Abstract] | |||||||||
Granted (in shares) | 259,086 | 98,195 | 1,021,166 | 763,578 | |||||
Stock based compensation | $ 510 | $ 1,186 | $ 957 | $ 1,686 | |||||
Stock option exercised (in shares) | 0 | 0 | 0 | 0 | |||||
Number of shares outstanding (in shares) | 4,962,489 | 4,962,489 | 4,410,258 | ||||||
Weighted average fair value per share of options granted (in dollars per share) | $ 1.35 | $ 3.36 | $ 1.95 | $ 2.83 |
Stock-based Compensation, Weigh
Stock-based Compensation, Weighted Average Assumptions Used in Black-Scholes Option-pricing Model (Details) - 2018 Equity Incentive Plan [Member] - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Weighted Average Assumptions Used in Black-Scholes Option-pricing Model [Abstract] | ||||
Expected stock price volatility | 98.30% | 94.40% | 97.70% | 95.30% |
Expected life of options | 5 years 6 months | 5 years 9 months 18 days | 5 years 10 months 24 days | 6 years 1 month 6 days |
Expected dividend yield | 0% | 0% | 0% | 0% |
Risk free interest rate | 4.40% | 3.70% | 4.20% | 3.70% |
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||||
Stock options vested (in shares) | 141,817 | 374,757 | 306,372 | 620,824 |
Stock options forfeited (in shares) | 124,030 | 254,966 | 468,935 | 254,966 |
Former Chief Executive Officer [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Abstract] | ||||
Stock options vested (in shares) | 145,418 | |||
Stock options forfeited (in shares) | 249,633 |
Stock-based Compensation, Restr
Stock-based Compensation, Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Restricted Stock Units [Abstract] | ||||
Stock based compensation | $ 806 | $ 1,422 | $ 1,791 | $ 2,226 |
Restricted Stock Units [Member] | ||||
Restricted Stock Units [Abstract] | ||||
Vested (in shares) | 104,880 | 144,162 | ||
Forfeited (in shares) | 0 | 82,670 | ||
Stock based compensation | $ 296 | $ 208 | $ 589 | $ 265 |
Restricted Stock Units [Member] | Former Chief Executive Officer [Member] | ||||
Restricted Stock Units [Abstract] | ||||
Vested (in shares) | 33,614 | 33,614 | ||
Forfeited (in shares) | 100,842 | 100,842 | ||
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | ||||
Restricted Stock Units [Abstract] | ||||
Granted (in shares) | 278,858 | 124,880 | 592,222 | 416,464 |
Weighted average grant date fair value of RSUs granted (in dollars per share) | $ 1.73 | $ 5.09 | $ 2.24 | $ 3.98 |
Vesting period | 1 year | |||
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | Maximum [Member] | ||||
Restricted Stock Units [Abstract] | ||||
Vesting period | 4 years | |||
Restricted Stock Units [Member] | 2020 Equity Incentive Plan [Member] | Vesting Annually [Member] | ||||
Restricted Stock Units [Abstract] | ||||
Vesting percentage | 25% | 25% |
Stock-based Compensation, Commo
Stock-based Compensation, Common Stock Issued for Services (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Common Stock Issued for Services [Abstract] | ||||
Granted stock awards for services performed (in shares) | 4,340 | 81,234 | 72,986 | |
Weighted grant date fair value per share of services granted (in dollars per share) | $ 6.38 | $ 3.01 | $ 3.77 | |
Share based compensation for services | $ 0 | $ 28 | $ 245 | $ 275 |
Stock-based Compensation, Gener
Stock-based Compensation, General (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) shares | |
General [Abstract] | |
Unrecognized stock-based compensation cost | $ | $ 7.3 |
Weighted average period to recognized stock-based compensation | 1 year 9 months |
2020 Plan Evergreen Provision [Member] | |
General [Abstract] | |
Common stock available for future issuance (in shares) | 1,596,826 |
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 | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | 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, Viatris License Agreement (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Nov. 06, 2022 USD ($) | Nov. 30, 2022 USD ($) | Jun. 30, 2024 USD ($) Performanceobligation | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) Performanceobligation | Jun. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Collaboration and License Agreement [Abstract] | |||||||
Revenue recognized | $ 1,112 | $ 3,674 | $ 2,823 | $ 5,423 | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||||
Revenue recognized | $ 1,112 | 3,674 | $ 2,823 | 5,423 | |||
Viatris License Agreement [Member] | |||||||
Collaboration and License Agreement [Abstract] | |||||||
Non-refundable cash payment received | $ 35,000 | ||||||
Maximum amount of payments receivable for development, regulatory and commercial milestones | $ 130,000 | ||||||
Milestone payments to be received | 10,000 | ||||||
Maximum percentage of tiered royalties receivable | 20% | 20% | |||||
Number of distinct performance obligations | Performanceobligation | 2 | 2 | |||||
Aggregate transaction price to be recognized | $ 40,000 | ||||||
Period of non-cancellation window agreement | 120 days | ||||||
Non-cancellation period of constrained | 120 days | ||||||
Royalty payments | $ 19,000 | $ 22 | |||||
Revenue recognized | 1,100 | 3,700 | 2,823 | 5,423 | |||
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||||
Beginning Balance | 1,407 | 3,552 | |||||
Revenue recognized | 1,100 | 3,700 | 2,823 | 5,423 | |||
Ending Balance | $ 948 | $ 2,595 | 948 | 2,595 | |||
Viatris License Agreement [Member] | License Transfer Fee [Member] | |||||||
Collaboration and License Agreement [Abstract] | |||||||
Aggregate transaction price to be recognized | 35,000 | ||||||
Estimated standalone selling price for license agreement | 287,800 | ||||||
Transaction price allocation of ESSP obligations | 39,300 | ||||||
Reconciliation of Closing Balance of Contract Asset [Abstract] | |||||||
Reclassification to accounts receivable related to costs billed under the Viatris License Agreement | (3,282) | $ (6,380) | |||||
Viatris License Agreement [Member] | Research and Development Services [Member] | |||||||
Collaboration and License Agreement [Abstract] | |||||||
Aggregate transaction price to be recognized | 5,000 | ||||||
Estimated standalone selling price for license agreement | 5,000 | ||||||
Transaction price allocation of ESSP obligations | $ 700 | ||||||
Viatris License Agreement [Member] | Sales Milestones [Member] | |||||||
Collaboration and License Agreement [Abstract] | |||||||
Milestone payment requirements attributed to the FDA's approval | $ 10,000 | ||||||
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) | 6 Months Ended |
Jun. 30, 2024 USD ($) Milestone | |
BioSense License and Assignments Agreement [Member] | |
Collaboration and License Agreement [Abstract] | |
Maximum amount of payments receivable for development, regulatory and commercial milestones | $ 84,500,000 |
Milestone payments received | 0 |
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% |
Net loss per share, Anti-diluti
Net loss per share, Anti-dilutive Securities Excluded from Computation of Net Income (Loss) per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Series A and RDO Warrants [Member] | ||||
Net Loss Per Share [Abstract] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 7,204,299 | 7,204,299 | 7,204,299 | 7,204,299 |
Stock Options [Member] | ||||
Net Loss Per Share [Abstract] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 4,962,489 | 3,444,656 | 4,962,489 | 3,444,656 |
Restricted Stock Units [Member] | ||||
Net Loss Per Share [Abstract] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 1,167,090 | 282,008 | 1,167,090 | 282,008 |
Former Rexahn Warrants [Member] | ||||
Net Loss Per Share [Abstract] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 0 | 58,597 | 0 | 58,597 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Taxes [Abstract] | ||||
Effective tax rate | 0% | 0% | 0% | 0% |
Pre-tax income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |
Deferred Compensation Plan (Det
Deferred Compensation Plan (Details) - 401K Plan [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Oct. 01, 2021 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
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 | $ 43 | $ 22 | $ 101 | $ 56 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 40 Months Ended | |||
Aug. 07, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | |
Subsequent Events [Abstract] | ||||||
Proceeds from Issuance of Common Stock | $ 4,041,000 | $ 0 | ||||
Issuance costs | $ 83,000 | $ 0 | ||||
ATM [Member] | ||||||
Subsequent Events [Abstract] | ||||||
Shares sold (in shares) | 538,566 | 0 | 1,389,116 | 0 | 7,434,432 | |
Proceeds from Issuance of Common Stock | $ 1,100,000 | $ 3,300,000 | $ 26,000,000 | |||
Issuance costs | $ 25,000 | $ 190,000 | $ 900,000 | |||
Subsequent Event [Member] | ATM [Member] | ||||||
Subsequent Events [Abstract] | ||||||
Shares sold (in shares) | 219,406 | |||||
Proceeds from Issuance of Common Stock | $ 500,000 | |||||
Issuance costs | $ 11,000 |