Opus Genetics, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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Sep 30, 2026 · Filed Nov 10, 2026
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Notes to Condensed Consolidated Financial Statements (unaudited)
- Company Description and Summary of Significant Accounting Policies
Nature of Business and Basis of Presentation
Opus Genetics, Inc. (the “Company” or “Opus”), a Delaware corporation formerly known as Ocuphire Pharma, Inc., is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (“IRDs”). The Company also has a small molecule therapy for other ophthalmic disorders. The Company’s headquarters is located in Durham, North Carolina.
The Company’s pipeline is centered on adeno‑associated virus (“AAV”) based gene therapy programs addressing genetically defined forms of IRD, including OPGx‑LCA5, which is currently being evaluated for the treatment of Leber congenital amaurosis caused by mutations in the LCA5 gene, and OPGx‑BEST1, which is currently being evaluated for retinal diseases associated with mutations in the BEST1 gene. In addition, the Company is advancing other gene therapy programs, including RDH12, MERTK, RHO, CNGB1 and NMNAT1, and research activities targeting additional monogenic retinal disorders.
Apart from gene therapies, the Company’s pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size.
In November 2022, the Company entered into a license and collaboration agreement (as amended, the “Viatris License Agreement”) with 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% (“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 U.S. Food and Drug Administration (“FDA”) for the treatment of pharmacologically induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, or a combination thereof under the brand name RYZUMVI® in September 2023 and was launched commercially in April 2024. In October 2026, the FDA approved PSfor the treatment of presbyopia in adults (see Note 16 – Subsequent Events). The Company is also developing PS for the treatment of decreased vision under mesopic (low-light) conditions following keratorefractive surgery, pursuant to a Special Protocol Assessment agreement with the FDA.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and include the accounts of the Company and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. 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 Company’s fiscal year begins on January 1 and ends on December 31.
The December 31, 2025 condensed consolidated 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. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 12, 2026.
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
Since its inception, the Company has devoted substantially all of its resources to drug development and clinical trials.
As of September 30, 2026, the Company had $89.0 million in cash and cash equivalents. The Company believes its current available cash and cash equivalents will be sufficient to fund its operations for at least the next 12 months from the date of issuance of these financial statements.
In the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future; however, these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions to generate the liquidity ultimately required.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
Segment Information
Operating segments are components of an enterprise for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker (the "CODM") in deciding how to allocate resources and assess performance. The Company’s CODM is its Chief Executive Officer, who views the Company’s operations and manages its business inone operating segment, which is the business of development of products related to vision performance and health. Accordingly, the condensed consolidated financial statements and accompanying notes contained herein include the measure of profit or loss, categories of expenses and other financial information that is evaluated by the Company’s Chief Executive Officer.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 1,“Company Description and Summary of Significant Accounting Policies” to the consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2025, that was filed with the SEC on March 12, 2026. Since the date of those financial statements, there were no material changes to the significant accounting policies, except as discussed below.
Fair Value Option Election
The Company has elected to account for its senior secured notes (the "Notes") under the fair value option in accordance with ASC 825, Financial Instruments. The Notes were issued pursuant to the senior secured note purchase agreement (as amended from time to time, the “Note Purchase Agreement”), dated as of April 2, 2026, by and among the Company and certain of its subsidiaries as guarantors and OPCM SA LLC, as purchaser agent (“Purchaser Agent”), and certain purchasers party thereto (the “Purchasers”) (see Note 7 – Debt) andare financial liabilities that contain certain embedded features that otherwise may have required separate evaluation and potential bifurcation under ASC 815, Derivatives and Hedging. Under the fair value option, the Notes were initially recognized at fair value on the issuance date and are subsequently remeasured at fair value at each reporting date. Changes in fair value are recognized in earnings, except for changes attributable to instrument-specific credit risk, which are recognized in other comprehensive income.
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU is intended to improve the disclosures related to expenses and provide investors more detailed information about certain types of expenses. This ASU is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the potential impact that this new standard will have on its consolidated financial statements and related disclosures.
- Cash, cash equivalents and restricted cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
| As of | ||
|---|---|---|
| September 30,2026 | December 31,2025 | |
| Cash and cash equivalents | $88,974 | $45,091 |
| Restricted cash | 100 | — |
| Total cash, cash equivalents and restricted cash | $89,074 | $45,091 |
Amounts included in restricted cash as of September 30, 2026 represent cash held as collateral for outstanding letters of credit provided as security deposit for the Company's credit card facility.
- 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 September 30, 2026 and December 31, 2025, 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 value of the long-term funding agreement, related party line item was determined on an amortized cost basis, based on an effective rate of interest.
The fair values of the financial liabilities associated with the March 2025 Warrants and, prior to their exercise, the March 2025 Private Placement Warrants (as defined below) are estimated using Monte Carlo simulation models that incorporate Level 3 inputs, including the Company’s stock price, expected volatility, expected term (including the estimated probability and timing of the call features) and risk-free interest rates (see Note 9 – Financings).
The fair value of the financial liabilities associated with the Notes pursuant to the Note Purchase Agreement represents the present value of estimated future payments, including interest, principal, and Repayment Amount (as defined in the Note Purchase Agreement; see Note 7 – Debt). The fair value measurement is based on significant Level 3 unobservable inputs such as the probability and timing of the Repayment Amount and the discount rate. The Company determined the fair value of the Notes utilizing a discounted cash flow model of estimated future payments including interest, principal, and Repayment Amount utilizing a discount rate calculated as the term-matched risk-free rate plus credit spread. At April 21, 2026, the Notes issuance date, the Company utilized a discount rate of 8.9% and determined the fair value of the Notes to be$35.0 million. At September 30, 2026, the Company utilized a discount rate of 10.8%. The fair value of the Notes at September 30, 2026 was$34.5 million, which differed from the contractual principal amount of$35.7 million, inclusive of paid-in-kind interest, by$(1.2) million. Significant increases or decreases in any of these inputs in isolation could result in a significantly lower or higher fair value measurement.
There were no transfers between fair value hierarchy levels during the three and nine months ended September 30, 2026 and 2025.
The fair value of financial instruments measured on a recurring basis is as follows (in thousands):
| Description | Total | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Financial liabilities: | ||||
| Warrant liabilities | $11,151 | $— | $— | $11,151 |
| Notes | $34,530 | $— | $— | $34,530 |
| Total financial liabilities at fair value | $45,681 | $— | $— | $45,681 |
| Description | Total | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Financial liabilities: | ||||
| Warrant liabilities | $25,985 | $— | $— | $25,985 |
| Notes | $— | $— | $— | $— |
| Total financial liabilities at fair value | $25,985 | $— | $— | $25,985 |
The following table provides a roll-forward of the warrant financial liability measured at fair value on a recurring basis using unobservable Level 3 inputs for the nine months ended September 30, 2026 and 2025 (in thousands):
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Warrant liabilities | ||
| Balance as of beginning of period | $25,985 | $— |
| Issuance of March 2025 Warrants and March 2025 Private Placement Warrants | — | 15,520 |
| Change in fair value | 71,513 | 5,805 |
| Warrant exercises | (86,347) | — |
| Balance as of end of period | $11,151 | $21,325 |
The following table provides a roll-forward of the Notes financial liability measured at fair value on a recurring basis using unobservable Level 3 inputs for the period from April 21, 2026 through September 30, 2026 (in thousands):
| Fair value at April 21, 2026 (issuance) | $35,000 |
|---|---|
| Change in fair value reported in net loss | 1,287 |
| Change in fair value reported in other comprehensive income | (1,106) |
| Interest payments | (651) |
| Fair value at September 30, 2026 | $34,530 |
There were no financial instruments measured on a non-recurring basis for any of the periods presented.
- Commitments and Contingencies
Apexian Sublicense Agreement
On January 21, 2020, the Company entered into a sublicense agreement with Apexian Pharmaceuticals, Inc. (“Apexian”), pursuant to which the Company obtained exclusive worldwide patent and other intellectual property rights. In exchange for the patent and other intellectual property rights, the Company agreed to certain milestone payments and royalty payments on future sales (see Note 11 – Apexian Sublicense Agreement). The sublicense agreement was terminated effective July 10, 2026, and the Company has no further milestone or royalty payment obligations thereunder.
University of Pennsylvania LCA5/RDH12 License Agreement
On June 15, 2022, Opus entered into an amended and restated license agreement (the “LCA5/RDH12 Agreement”) with the Trustees of the University of Pennsylvania (“Penn”) pursuant to which it was granted an exclusive, royalty-bearing license to certain patents and a non-exclusive license to certain information relating to products directed towards treatment or correction of mutation of the LCA5 or RDH12 genes. In return for these rights, the Company is obligated to make certain development, regulatory and commercial milestone payments up to a maximum potential aggregate amount of $2.6 million and royalty payments on future net sales of such products. Until the Company is required to pay royalties under the LCA5/RDH12 Agreement, the Company must pay ade minimis annual license maintenance fee to Penn. The Company is also obligated to make payments on any sublicense income, with such percentage depending on the stage of product development. As of September 30, 2026, the Company determined that none of the future obligations under the LCA5/RDH12 Agreement were probable, and accordingly, no liabilities were recorded related to the agreement.
Iveric Asset Purchase Agreement – BEST1 and RHO Programs
On December 23, 2022, Opus entered into an asset purchase agreement (the “Iveric Agreement”) with a subsidiary of Iveric Bio, Inc. (“Iveric”) pursuant to which the Company acquired certain assets, including the BEST1 License (as defined below), relating to the BEST1 and RHO products. In return for these rights, the Company is obligated to make payments to Iveric upon the achievement of specified development, regulatory and commercial milestones, the maximum potential aggregate amount of such payments being $111.7 million. As of September 30, 2026, the Company determined that none of the future obligations under the Iveric Agreement were probable, and accordingly, no liabilities were recorded related to the Iveric Agreement.
Penn and University of Florida BEST1 License Agreement
On April 10, 2019, Iveric entered into an exclusive patent license agreement (as amended, the “BEST1 License”) with Penn and the University of Florida Research Foundation (“UF”), which agreement was assigned to Opus under the terms of the Iveric Agreement. Under the BEST1 License, Opus received exclusive patent rights and non-exclusive know-how and data rights with regard to products to treat diseases associated with mutations in the BEST1 gene. In return for these rights, the Company is obligated to make payments to Penn upon the achievement of certain development, regulatory and commercial milestones, the maximum potential aggregate amount of such payments being $76.4 million. The Company is also obligated to make royalty payments on future net sales of licensed BEST1 products. Until the Company is required to pay royalties under the BEST1 License, the Company must pay ade minimis annual license maintenance fee to UF and Penn. The Company must also make payments on any sublicense income, with such percentage depending on the stage of product development. The Company has not recorded any sublicense income during any of the periods presented. In consideration for Penn and UF’s consent to the assignment of the BEST1 License to the Company under the Iveric Agreement, the Company will also pay Penn a percentage of each milestone payment that the Company is required to pay to Iveric under the Iveric Agreement. As of September 30, 2026, the Company determined that none of the future obligations under the BEST1 License were probable, and accordingly, no liabilities were recorded related to the BEST1 License.
Penn and UF RHO License Agreement
On June 6, 2018, Iveric entered into an exclusive patent license agreement (the “RHO License”) with Penn and UF pursuant to which the Company has exclusive patent rights and non-exclusive know-how and data rights with regard to products to treat rhodopsin-mediated diseases as a result of the Iveric Agreement as defined above. In return for these rights, the Company is obligated to make development, regulatory and commercial milestone payments, the maximum potential aggregate amount of such payments being $93.5 million and royalty payments on future sales of such products. As of September 30, 2026, the Company determined that none of the future obligations under the RHO License were probable, and accordingly, no liabilities were recorded related to the RHO License.
Penn License Assignment and Share Issuance
On July 20, 2026, the Company entered into agreements with Penn to assign and amend certain existing intellectual property license arrangements and extend certain contractual rights and obligations. In connection with these agreements, the Company entered into a stock subscription agreement pursuant to which it agreed to issue 200,000 shares of its common stock with a fair value of $0.6 million to Penn. The common stock was issued on July 23, 2026.
Massachusetts Eye and Ear Infirmary License Agreement
On November 9, 2021, Opus entered into a license agreement (“MEEI License”) with the Massachusetts Eye and Ear Infirmary (“MEEI”), granting an exclusive worldwide license of MEEI patents for use in the NMNAT1 program for all products and processes including the treatment of retinal disease in humans, and a non-exclusive worldwide license to technological information. In return for these rights, the Company is obligated to make development and regulatory milestone payments, the maximum potential aggregate amount of such payments being $0.4 million and royalty payments on future sales of such products. As of September 30, 2026, the Company determined that none of the future obligations under the MEEI License were probable, and accordingly, no liabilities were recorded related to the MEEI License.
Rexahn CVR Agreement
On November 5, 2020, the Company completed a merger transaction with Rexahn Pharmaceuticals, Inc. (“Rexahn" and such merger transaction, the "Rexahn Merger”). In connection with the Rexahn Merger, the Company, Shareholder Representative Services LLC, as representative of the Rexahn stockholders prior to the Rexahn Merger, and Olde Monmouth Stock Transfer Co., Inc., as the rights agent, entered into the Contingent Value Rights Agreement (the “CVR Agreement”).
Pursuant to the terms of the Rexahn Merger and the CVR Agreement, Rexahn stockholders of record as of immediately prior to the effective time of the Rexahn Merger receivedone contingent value right (“CVR”) for each share of Rexahn common stock held.
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 (as defined in the CVR Agreement) and the payment of all amounts payable thereunder. As of September 30, 2026, no payments subject to the CVR Agreement had been received beyond those previously reported in the second and third quarters of calendar year 2021. In addition, no milestones had been accrued as of September 30, 2026, as there wereno potential milestones yet considered probable beyond those previously reported.
Facility and Other Leases
The Company’s headquarters and laboratory facilities are located in Durham, North Carolina and are leased on a month-to-month basis. All of the Company's leases qualify for the short-term lease exception under ASC 842, Leases.
The rent expense associated with all leases amounted to $0.1 million and$0.3 million during thethree and nine months ended September 30, 2026, respectively, and $0.1 million and $0.2 million during the three and nine months ended September 30, 2025, respectively.
Other
In the ordinary course of business, from time to time, the Company may be subject to a broad range of claims and legal proceedings that relate to contractual allegations, patent infringement and other claims. In addition, the Company from time to time may be potentially committed to reimburse third parties for costs incurred associated with business development related transactions upon the achievement of certain milestones. The Company establishes accruals when applicable for matters and commitments for which it believes losses are probable and can be reasonably estimated.
- Supplemental Balance Sheet Information
Prepaids and other current assets
Prepaids and other current assets consist of the following (in thousands):
| As of | ||
|---|---|---|
| September 30,2026 | December 31,2025 | |
| Prepaid research and development services | $1,459 | $845 |
| Prepaid insurance and other professional services | 496 | 814 |
| Warrant exercise receivable | 1,689 | — |
| Other | 605 | 129 |
| Total | $4,249 | $1,788 |
Accrued expenses
Accrued expenses consist of the following (in thousands):
| As of | ||
|---|---|---|
| September 30,2026 | December 31,2025 | |
| R&D services and supplies | $2,790 | $2,061 |
| Compensation and benefits | 2,556 | 1,992 |
| Professional services | 753 | 420 |
| Other | 6 | 15 |
| Total | $6,105 | $4,488 |
- Related Party Transactions
Consulting Agreements with Dr. Pepose
On April 11, 2024, the Company entered into a consulting agreement (the “Pepose Consulting Agreement”) with Dr. Jay S. Pepose, a former director of the Company. Pursuant to the Pepose Consulting Agreement, Dr. Pepose was paid a monthly consulting fee and received an award of 32,000 restricted stock units (“RSUs”), as well as stock options to purchase 48,000 shares of the Company’s common stock. The RSUs vested in 12 equal monthly installments that began on May 11, 2024 and concluded on April 11, 2025. On November 21, 2024, the Pepose Consulting Agreement was amended to continue through April 11, 2026, and was further amended on April 10, 2026 to continue through May 11, 2026.
Under the Pepose Consulting Agreement, the Company incurred consulting expenses ofzero and$0.2 million during thethree and nine months ended September 30, 2026, respectively, and $0.1 million and $0.4 million during the three and nine months ended September 30, 2025, respectively.
March 2025 Subscription Agreements with Dr. George Magrath and Cam Gallagher
On March 21, 2025, the Company entered into a subscription agreement with each of Dr. George Magrath, the Company’s Chief Executive Officer, and Cam Gallagher, the Chair of the Company’s board of directors (the “Board”), in connection with a private offering of the Company's securities (see Note 9 – Financings).
Letter Agreement and Strategic Partnership—FFB
On August 25, 2022, the Company entered into a binding letter of agreement (“2022 Binding Letter Agreement”) with Foundation Fighting Blindness (“FFB”) and the Jaeb Center for Health Research (the “JCHR”) to collaborate on natural history studies involving individuals with retinal dystrophies associated with mutations in multiple genes of interest. Under the terms of the 2022 Binding Letter Agreement, FFB and the JCHR had the sole responsibility and authority to design and conduct the study, with input from the Company. Subject to certain conditions, the 2022 Binding Letter Agreement required that the Company provide FFB with a total of $2.0 million of funding to support the study, such amount being payable in an initial installment of $0.4 million at the time of submission of the final study protocol to the Institutional Review Board of the JCHR and, subject to certain conditions, infour annual installments of $0.4 million on the anniversaries of such submission. On May 27, 2025, the Company entered into a binding letter of agreement (“2025 Letter
Agreement”) with FFB and the JCHR, which superseded and canceled the 2022 Binding Letter Agreement. As of September 30, 2026, a total of $0.4 million was paid by the Company under the 2022 Binding Letter Agreement andno more payments were due under the 2022 Binding Letter Agreement.
Under the 2025 Letter Agreement, the Company will collaborate with FFB and the JCHR on portions of a study involving individuals with retinal dystrophies associated with mutations in the RDH12 or BEST1 genes (the “Study”). The term of this 2025 Letter Agreement ends on the date that istwo months from the Study’s completion. FFB and the JCHR, as its designee, shall have the sole responsibility and authority to design and conduct the Study, with input from the Company. Under the 2025 Letter Agreement, the Company is obligated to maketwo payments to FFB: (1) $0.3 million on or before June 30, 2025 and (2) $0.3 million on or before January 31, 2027 upon receipt of semi-annual reports from FFB outlining the progress being made in the Study, including visit completion status and publication plans, and the ability for the Company to provide ongoing comments and suggestions regarding possible changes to the Study. Such payments shall constitute the sole compensation paid to FFB in return for Company access to research materials and datasets.
The Company paid the initial $0.3 million due on or before June 30, 2025 under the 2025 Letter Agreement which was recorded as research and development expense. As of September 30, 2026, the Company is required to fund one additional installment in the aggregate of $0.3 million upon receipt of future semi-annual reports. A total ofzero and$0.2 million of the remaining $0.3 million obligation was recognized in the condensed consolidated financial statements during thethree and nine months ended September 30, 2026, respectively.
RDF Agreement
On June 13, 2025, the Company entered into a funding agreement (the “RDF Agreement”) with the Foundation Fighting Blindness Retinal Degeneration Fund (“RDF”), whose sole member is FFB, relating to the Company’s program to develop gene therapies to treat patients impacted by retinitis pigmentosa caused by pathogenic variants in the Mer proto-oncogene tyrosine kinase (MERTK) gene (the “MERTK Program”). The RDF Agreement provides for nondilutive funding by RDF of up to $2.0 million to support the development of the MERTK Program, $1.0 million of which was disbursed to the Company in June 2025 and up to $1.0 million of which may be disbursed to the Company upon achievement of a specified development milestone subject to RDF’s receipt of eligible funds.
Under the RDF Agreement, the Company is subject to certain diligence obligations to develop and commercialize a product under the MERTK Program. If the Company is unable to achieve certain milestones by certain dates, or otherwise fails to meet its diligence obligations, the Company will be obligated to collaborate with RDF to out-license or otherwise make applicable rights available to a third party.
In addition, the Company will pay a milestone payment equal to the total amounts funded by RDF under the RDF Agreement upon the achievement of a regulatory milestone. The Company will also make tiered royalty payments to RDF in low-to-mid single-digit percentages until RDF has received aggregate royalty payments equal to 300% of the amounts funded by RDF under the RDF Agreement. In the event of a change of control of the Company or a sale or exclusive license of the MERTK Program, RDF will have the option to require the Company to buy out RDF’s interest under the RDF Agreement for an amount equal to 100% of the funds disbursed to the Company under the RDF Agreement. The RDF Agreement may be terminated by either party for cause, including material breach or bankruptcy, subject to a cure period.
The RDF Agreement was accounted for as debt under ASC 470, Debt. ASC 470 requires interest expense to be recorded under an effective interest rate method. Interest expense was$0.1 million and $0.2 million during the three and nine months ended September 30, 2026, respectively, based on an effective rate of interest of 24.2% and was recorded in other income, net in the accompanying condensed consolidated statements of comprehensive loss. There was$0.1 million of interest expense related to the RDF Agreement during thethree and nine months ended September 30, 2025. The accreted liability in connection with the RDF Agreement was $1.4 million as of September 30, 2026 and was recorded under the funding agreement, related party line item in the accompanying condensed consolidated balance sheets.
- Debt
Note Purchase Agreement
On April 2, 2026, the Company and certain of its subsidiaries as guarantors entered into the Note Purchase Agreement with OPCM SA LLC, as Purchaser Agent, and certain Purchasers. Capitalized terms used in this section but not defined herein have the meanings given to such terms in the Note Purchase Agreement.
The Note Purchase Agreement provides for, among other things, the issuance of up to $155.0 million of Notes, of which the Purchasers have committed to purchase $105.0 million and the remaining $50.0 million is uncommitted. The issuance and purchase of each tranche of Notes is subject to the satisfaction of customary funding conditions and, in certain cases, achievement of certain pre-determined milestones. An initial tranche of $35.0 million was funded at the initial closing following the effective date of the Note Purchase Agreement, which occurred on April 21, 2026 (the “First Purchase Date”) resulting in net proceeds of approximately $34.5 million. A second tranche of $35.0 million will be available at the Company’s option until April 2, 2027. A third tranche (the “Third Tranche”) of $25.0 million will be funded upon the FDA Application Acceptance Date for OPGx-LCA5 on or prior to March 31, 2028. A fourth tranche of $10.0 million will be available, (a) at the Company’s option, if the FDA Approval Date for OPGx-LCA5 has occurred or, (b) at the Purchaser Agent’s option, if the Third Tranche has not been funded (whether or not the FDA Application Acceptance Date or FDA Approval Date has occurred), in each case, on or prior to March 31, 2028. An additional $50.0 million of uncommitted financing (separated into two equal tranches of $25.0 million) will be available upon the request of the Company but subject to the approval of each Purchaser in its sole discretion until December 31, 2027.
The Notes mature on April 21, 2033 (the “Maturity Date”) and bear interest at a rate per annum equal to Term SOFR for the three-month interest period (subject to a 3.68% floor) plus the Applicable Margin, payable quarterly. Interest payable on the first eight interest payment dates following the effective date of the Note Purchase Agreement shall be payable as follows:50% of the interest owed for each applicable period shall be paid in kind and the remaining 50% of interest owed for such applicable period shall be paid in cash. Thereafter,100% of the interest owed for each applicable period shall be paid in cash. The Company shall make a payment of principal on each outstanding Note on the sixth anniversary of the First Purchase Date in an amount equal to half of the aggregate principal amount of such Notes outstanding on such date, with the remaining balance payable on the Maturity Date.
Concurrently with the Note Purchase Agreement, on April 2, 2026, the Company entered into a stock purchase and conversion agreement (the “Purchase and Conversion Agreement”) with the Purchasers providing for the issuance of an aggregate of 1,116,070 shares (the “Purchase Shares”) of its common stock at a price per share equal to $4.48 (the “Per Share Purchase Price”), for an aggregate purchase price of $5.0 million(see Note 9 – Financings). In connection with the Note Purchase Agreement and Purchase and Conversion Agreement, the Company received aggregate gross proceeds of $40.0 million from the issuance of Notes and Purchase Shares. The Company elected to account for the Notes under the fair value option in accordance with ASC 825(see Note 3 – Fair Value Measurements). At issuance, the fair value of the Notes was determined to be $35.0 million, and such amount was allocated to the Notes. The residual $5.0 million of proceeds was allocated to the Purchase Shares issued in connection with the Purchase and Conversion Agreement and recorded within stockholders’ equity (deficit).
On April 13, 2026, the Company, the Purchaser Agent and the Purchasers entered into a Waiver and Omnibus Amendment to the Note Purchase Agreement and Purchase and Conversion Agreement (the “Waiver and Omnibus Amendment”). The Waiver and Omnibus Amendment revised the Per Share Purchase Price to the lower of $4.48 per share or the 30-day volume-weighted average price of the Company's common stock ending on the issuance date of the Purchase Shares, revised the Notes conversion price to the lower of $6.72 or 150% of the Per Share Purchase Price and modified the timing and closing conditions for issuance of the Purchase Shares. The Purchase Shares were issued on May 26, 2026, for aggregate gross proceeds of $5.0 million.
Pursuant to the Note Purchase Agreement, as amended by the Waiver and Omnibus Amendment, following the Issuance Authorization and prior to the date that is 18 months after the date that is 30 days after the effective date of the Initial Registration Statement, any Purchaser may, at any time and from time to time, subject to the notice and other terms and conditions set forth in the Note Purchase Agreement, elect to convert up to 10% in the aggregate of the principal amount of such Purchaser’s Notes then outstanding (the “Conversion Amount”) into shares (the “Conversion Shares”) of the Company’s common stock. The number of Conversion Shares issuable upon such conversion shall be equal to the Conversion Amount divided by the lower of $6.72 and 150% of the Per Share Purchase Price, in each case as amended by the Waiver and Omnibus Amendment. Upon any such conversion, an aggregate principal amount of Notes equal to the Conversion Amount shall be deemed paid and satisfied in full and shall cease to accrue interest. Any interest accrued and unpaid through and including the date of such conversion shall remain outstanding and shall be payable in cash on the next interest payment date (or, if the Company and the Purchasers so elect in writing, shall be convertible into Conversion Shares).
The Company may voluntarily prepay the Notes in full at any time subject to a prepayment premium. Moreover, a prepayment premium may also be payable by the Company upon the occurrence of, (i) at any time prior to the first anniversary of the First Purchase Date, an acceleration of the obligations under the Note Purchase Agreement following an event of default (other than a change of control) or, (ii) at any time prior to the date that is 18 months after the First Purchase Date, a change of control of the Company that is not otherwise consented to by the Purchasers holding a majority of the outstanding Notes. The Company is required to make mandatory prepayments of the Notes with net cash proceeds from insurance proceeds or condemnation awards, in each case, subject to certain exceptions and reinvestment rights.
The obligations of the Company under the Note Purchase Agreement are guaranteed by certain of its existing subsidiaries and are required to be guaranteed by subsequently acquired or organized subsidiaries, subject to certain exceptions (collectively, the “Guarantors”). The obligations of the Company under the Note Purchase Agreement and of the Guarantors under their respective guaranty are secured, subject to customary permitted liens and other agreed upon exceptions, by (a) a pledge of all of the equity interests of the Company’s and the Guarantors’ direct subsidiaries, and (b) a perfected security interest in substantially all of the Company’s and the Guarantors’ tangible and intangible assets. The Note Purchase Agreement contains customary representations and warranties and, among other customary terms, contains events of default which are customary for financings of this type, in certain circumstances subject to specified cure periods. Following an event of default and any cure period, if applicable, the Purchaser Agent will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Note Purchase Agreement, in addition to other remedies available to it as a secured creditor of the Company.
The Notes contain various embedded features, including conversion, prepayment, acceleration and tranche-related features, and the Company's election of the fair value option allows the Company to account for the Notes at fair value without separately evaluating potential embedded derivatives for bifurcation. Under the fair value option, the financial liability is initially measured at its fair value on the issuance date and subsequently remeasured at estimated fair value on a recurring basis at each reporting date. Changes in the fair value of the Notes, which include accrued interest, if any, are recorded as a component of fair value change in instruments measured at fair value in the condensed consolidated statements of comprehensive loss. The Company has not elected to present interest expense separately from changes in fair value and therefore does not separately present interest expense associated with the Notes. Changes in fair value caused by instrument-specific credit risk are presented separately in other comprehensive income (loss) in thecondensed consolidated statements of comprehensive loss and accumulated in accumulated other comprehensive income in the condensed consolidated balance sheets. The portion of total changes in fair value of the Notes attributable to changes in instrument-specific credit risk is determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes. Refer to Note 3 –Fair Value Measurements for a reconciliation of the change in fair value of the Notes for the period from April 21, 2026 through September 30, 2026.
Under the fair value option, debt issuance costs are expensed as incurred. The Company incurred approximately $1.3 million of transaction costs in connection with the Note Purchase Agreement and Purchase and Conversion Agreement, of which $1.1 million was allocated to the Notes and expensed as incurred, and $0.2 million was allocated to the common stock and recorded as a reduction of additional paid-in capital.
As of September 30, 2026, future principal payments under the Note Purchase Agreement are due as follows (in thousands):
| 2026 | — |
| 2027 | — |
| 2028 | — |
| 2029 | — |
| 2030 | — |
| 2031 | — |
| 2032 | 17,826 |
| 2033 | 17,825 |
| Total principal payments | $35,651 |
- Preferred Stock
Series B Preferred Stock
On February 18, 2026, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the “Series B Certificate of Designation”) in connection with the February 2026 Private Placement(see Note 9 – Financings). The Series B Certificate of Designation provided for the authorization of 7,374,632 shares of Series B preferred stock, of which 7,374,632 shares of Series B preferred stock were issued upon the closing of the February 2026 Private Placement. On April 20, 2026, the Company held its 2026 Annual Meeting of Stockholders. During the 2026 Annual Meeting, the Company's stockholders voted to approve an amendment to the Company's restated certificate of incorporation to increase the number of authorized shares of common stock from 125,000,000 to 250,000,000, which permitted the conversion of each share of Series B preferred stock, on a one-for-one basis, into common stock. Subsequently, on April 23, 2026, all shares of Series B preferred stock were converted into 7,374,632 shares of common stock.
Series A Preferred Stock
On October 22, 2024, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the “Series A Certificate of Designation”) in connection with its acquisition of legacy Opus Genetics, Inc. in October 2024 (the “Opus Acquisition”). The Series A Certificate of Designation provided for the authorization of 14,146 shares of Series A preferred stock, of which 14,145.374 shares of Series A preferred stock were issued upon close of the Opus Acquisition. On April 30, 2025, the Company held its 2025 Annual Meeting of Stockholders. During the 2025 Annual Meeting, the Company’s stockholders voted to approve the conversion of each share of Series A preferred stock into 1,000 shares of common stock. Subsequently, on May 5, 2025, all shares of Series A preferred stock were converted into 14,145,374 shares of common stock.
- Financings
Purchase and Conversion Agreement
Concurrently with the Note Purchase Agreement, on April 2, 2026, the Company entered into the Purchase and Conversion Agreement with the Purchasers providing for the issuance of an aggregate of 1,116,070 shares of the Company's common stock at a price per share equal to $4.48, for an aggregate purchase price of $5.0 million.
The Purchase and Conversion Agreement also provided the Purchasers with an option to acquire additional Purchase Shares (the “Option Shares”) at a price per share equal to $0.0001 (subject to adjustment as set forth in the Purchase and Conversion Agreement, the “Per Share Exercise Price”) in the event that prior to October 2, 2026, the Company issued shares of its common stock (or instruments exercisable for or convertible into shares of its common stock) at an effective sale price per share below the Per Share Purchase Price, subject to certain exceptions (a “Dilutive Equity Round”). The number of Option Shares issuable upon exercise of such option will be such that, accounting for the sale and issuance of the Option Shares, the weighted average of the Per Share Purchase Price and Per Share Exercise Price for all Purchase Shares (including Option Shares) issued pursuant to the Purchase and Conversion Agreement, taken together, shall equal the lowest effective sale price per share paid in cash by third party investors to the Company for its common stock issued by the Company in such Dilutive Equity Round.
The Purchase and Conversion Agreement was amended on April 13, 2026 to revise the Per Share Purchase Price to the lower of $4.48 per share or the 30-day volume-weighted average price of the Company's common stock ending on the issuance date of the Purchase Shares and to modify the timing and closing conditions for issuance of the Purchase Shares. The option to acquire Option Shares expired unexercised on October 2, 2026.
The issuance of the Purchase Shares pursuant to the Purchase and Conversion Agreement closed on May 26, 2026, resulting in the issuance of 1,116,070 shares of common stock for aggregate gross proceeds of $5.0 million. The Company evaluated the common stock issued under the Purchase and Conversion Agreement, together with the related forward share commitment and down-round participation right, and concluded that the common stock issuance should be classified in permanent equity. The related forward share commitment and down-round participation right were evaluated as freestanding financial instruments and derivative liabilities; however, the Company determined that the fair value of each was de minimis, and therefore no proceeds were allocated to those instruments. In connection with the Note Purchase Agreement and Purchase and Conversion Agreement, the Company received aggregate gross proceeds of $40.0 million from the issuance of Notes and Purchase Shares. A total of $35.0 million was allocated to the Notes based on the fair value on the First Purchase Date, with the residual $5.0 million of proceeds received under the Purchase and Conversion Agreement being allocated to the Purchase Shares and recorded within stockholders’ equity (deficit), net of allocated issuance costs of $0.2 million, with such issuance costs recorded as a reduction of additional paid-in capital.
February 2026 Private Placement
On February 13, 2026, the Company entered into a securities purchase agreement with certain investors for a private placement of 7,374,632 shares of Series B preferred stock, par value$0.0001 per share, at a purchase price of$3.39 per share. The private placement closed on February 18, 2026, resulting in gross proceeds of approximately$25.0 million. As a result of the approval by stockholders of the proposal to increase the Company's authorized shares of common stock at the
2026 Annual Meeting on April 20, 2026 and filing the associated amendment, all of the shares of Series B preferred stock were automatically converted into the same number of shares of common stock (see Note 8– Preferred Stock).
March 2025 Financings
On March 21, 2025, the Company entered into an underwriting agreement with Craig-Hallum Capital Group, LLC, as the sole underwriter. Pursuant to the underwriting agreement, the Company agreed to issue and sell, in an underwritten public offering (the “March 2025 Offering”),12,219,736 shares of common stock and warrants to purchase up to 21,052,631 shares of common stock (the “March 2025 Warrants”). Each share of common stock was sold together with one March 2025 Warrant to purchaseone share of common stock, at a price to the public of $0.95 per share and related March 2025 Warrant. The Company also issued 8,832,895 pre-funded warrants (“Pre-Funded Warrants”) at a price to the public of $0.9499 per Pre-Funded Warrant.
On March 21, 2025, the Company entered into a subscription agreement (the “Subscription Agreement”) with each of Dr. George Magrath, the Company’s Chief Executive Officer, and Cam Gallagher, the Chair of the Board. Pursuant to the Subscription Agreement, the Company agreed to issue and sell, in a private offering (the “March 2025 Private Placement”), a total of 392,157 shares of common stock to Dr. Magrath and 784,314 shares of common stock to Mr. Gallagher, as well as 392,157 warrants to purchase shares of common stock to Dr. Magrath and 784,314 warrants to purchase shares of common stock to Mr. Gallagher (“March 2025 Private Placement Warrants”) at an initial exercise price of$1.15 per share. See Note 6 – Related Party Transactions.
The combined gross proceeds from the March 2025 Offering and the March 2025 Private Placement, which both closed on March 24, 2025 (the “Closing Date”), were approximately $21.5 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company in the amount of $1.8 million.
March 2025 Warrants
The March 2025 Warrants have an initial exercise price equal to $0.95 per share of common stock and are exercisable forfive years from the date of issuance. The exercise prices and numbers of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders. A holder may not exercise the March 2025 Warrant if, after giving effect to such exercise, the holder (together with its affiliates) would beneficially own (as determined in accordance with the terms of the March 2025 Warrants) more than 4.99% (or, at the election of the holder,9.99%) of the outstanding common stock immediately after giving effect to the exercise. Lastly, certain volatility provisions in the event of a fundamental transaction precluded the March 2025 Warrants from being considered indexed to the Company’s own stock, and as such, were classified on the condensed consolidated balance sheets as warrant liabilities.
All outstanding March 2025 Warrants have been called by the Company. The Company announced OPGx-BEST1 Cohort 1 data on September 9, 2026, and on October 22, 2026, following satisfaction of the applicable conditions, the Company delivered call notices to the holders of all outstanding March 2025 Warrants (see Note 16 – Subsequent Events).
The fair value of the March 2025 Warrants as of September 30, 2026 and December 31, 2025 was $11.2 million and $24.6 million, respectively, and was recorded in the warrant liabilities line item in the accompanying condensed consolidated balance sheets. The fair value change during thenine months ended September 30, 2026 and 2025 was an expense of$68.5 million and$5.5 million, respectively. The fair value change during thethree months ended September 30, 2026 and 2025 was an expense of$26.7 million and$9.0 million, respectively. The fair value of these instruments was based on a Monte Carlo simulation incorporating a volatility rate of 75.0% and 72.5% as of September 30, 2026 and December 31, 2025, respectively, a risk-free rate of 4.9% and 3.6% as of September 30, 2026 and December 31, 2025, respectively, the market price of the Company’s common stock at $4.84 and$2.01 per share as of September 30, 2026 and December 31, 2025, respectively, and other factors over a simulated term of 3.5 years and 4.2 years at September 30, 2026 and December 31, 2025, respectively. As disclosed in Note 3 – Fair Value Measurements, the March 2025 Warrants are measured at fair value using significant unobservable inputs. Following the announcement of OPGx-BEST1 BIRD-1 Cohort 1 data on September 9, 2026, the uncertainty associated with the timing of the applicable data-release milestone was resolved. Accordingly, following satisfaction of the call conditions, changes in the fair value of the remaining March 2025 Warrants are expected to be driven primarily by changes in the market price of the Company’s common stock through the earlier of exercise or cancellation of the warrants.
March 2025 Private Placement Warrants
The March 2025 Private Placement Warrants had an initial exercise price equal to $1.15 per share of common stock and were exercisable forfive years from the date of issuance. The March 2025 Private Placement Warrants were callable by the Company in certain circumstances. As of September 30, 2026, all of the March 2025 Private Placement Warrants have been exercised and none remain outstanding.
All 1,176,471 March 2025 Private Placement Warrants were exercised during thethree months ended September 30, 2026. Accordingly, no March 2025 Private Placement Warrants were outstanding, and no related warrant liability was recorded, as of September 30, 2026. Immediately before each exercise, the related warrant liability was remeasured to fair value, with the resulting change in fair value recognized in earnings, and the warrant liability reclassified to additional paid-in capital upon exercise. The fair value change during thenine months ended September 30, 2026 and 2025 was an expense of$3.0 million and$0.3 million, respectively. The fair value change during thethree months ended September 30, 2026 and 2025 was an expense of$0.8 million and$0.5 million, respectively. As of December 31, 2025, the fair value of the March 2025 Private Placement Warrants was $1.4 million and was estimated using a Monte Carlo simulation incorporating an expected volatility rate of 72.5%, a risk-free rate of 3.6%, the market price of the Company's common stock of $2.01 per share, and a simulated term of 4.2 years, together with the estimated probability and timing of achieving the applicable data-release milestone and satisfying the related call conditions.
Pre-Funded Warrants
The Pre-Funded Warrants have an exercise price of $0.0001 per share of common stock and are immediately exercisable at any time until exercised in full. The exercise prices and numbers of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock. A holder may not exercise the Pre-Funded Warrant if, after giving effect to such exercise, the holder (together with its affiliates) would beneficially own (as determined in accordance with the terms of the Pre-Funded Warrants) more than 4.99% (or, at the election of the holder,9.99%) of the outstanding common stock immediately after giving effect to the exercise. In the event of a fundamental transaction, as defined in the form of Pre-Funded Warrant, the holders of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamental transaction.
The Pre-Funded Warrants were recorded in the accompanying condensed consolidated balance sheets as additional paid-in capital. During thethree months ended September 30, 2026, the Company issued 4,157,895 additional pre-funded warrants, with an exercise price of$0.0001 per share and terms substantially consistent with the Pre-Funded Warrants, to holders of March 2025 Warrants that elected to receive pre-funded warrants in lieu of shares of common stock upon exercise. These pre-funded warrants were classified in equity, with the related warrant liability and exercise proceeds recorded in additional paid-in capital.
On January 13, 2025, the Company filed a prospectus supplement with the SEC establishing an at-the-market equity offering program (the “Prior ATM Program”) for the offer and sale, from time to time, of shares of its common stock having an aggregate offering price of up to $40.0 million. On the same date, the Company entered into a sales agreement with Leerink Partners LLC (“Leerink”) relating to the Prior ATM Program (the “Prior Sales Agreement”). On August 6, 2026, the Company filed a new shelf registration statement on Form S-3 (File No. 333-298100), which included a base prospectus and a sales agreement prospectus relating to a new at-the-market equity offering program (the “New ATM Program”), and entered into a new sales agreement with Leerink and Cantor Fitzgerald & Co. (“Cantor”) (the “New Sales Agreement”). The Form S-3 was declared effective by the SEC on August 14, 2026. Under the New Sales Agreement and related sales agreement prospectus, the Company may offer and sell, from time to time through or to Leerink or Cantor, acting as sales agent or principal, shares of its common stock having an aggregate offering price of up to $125.0 million. The New Sales Agreement replaced the Prior Sales Agreement, and no additional shares may be sold under the Prior ATM Program.
During the three and nine months ended September 30, 2026, the Company sold zero and 1,000,000 shares of common stock, respectively, under the Prior ATM Program for gross proceeds ofzero and$2.3 million, respectively, before deducting issuance expenses. Total issuance expenses, including sales agent fees and legal and accounting expenses, were zero and$0.1 million, respectively, for thethree and nine month period ended September 30, 2026. The Company did not sell any shares under the New ATM Program during thethree and nine months ended September 30, 2026.
During the three and nine months ended September 30, 2025, the Company sold 1,472,703 and 1,825,656 shares of common stock, respectively, under the Prior ATM Program for gross proceeds of$1.7 million and $2.1 million, respectively, before deducting issuance expenses. Total issuance expenses, including sales agent fees and legal and accounting expenses, were$0.1 million and $0.3 millionfor thethree and nine month periods ended September 30, 2025, respectively.
Registered Direct Offering
On June 4, 2021, the Company entered into a placement agency agreement for a registered direct offering (“RDO”) with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the placement agency agreement, AGP on June 8, 2021 sold an aggregate of 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 of each RDO Warrant. The RDO was made pursuant to the Company’s 2021 shelf registration.
The RDO Warrants had an exercise price of $6.09 per share, and were exercisable from the initial issuance date of June 8, 2021 forfive years through June 8, 2026. As of September 30, 2026, no RDO Warrants were outstanding andnone were exercised prior to their expiration on June 8, 2026.
Subject to limited exceptions, a holder of an 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%.
Warrant Activity and Summary
| Warrants | ExercisePrice PerWarrant | WeightedAverage ExercisePrice | WeightedAverage Term(Years) | |
|---|---|---|---|---|
| Outstanding and exercisable at December 31, 2025 | 22,904,879 | $0.95-$6.09 | $1.31 | 3.98 |
| Issued | — | — | — | — |
| Exercised | (18,507,313) | $0.95-$1.15 | $0.96 | — |
| Expired | (1,538,461) | $6.09 | $6.09 | — |
| Outstanding and exercisable at September 30, 2026 | 2,859,105 | $0.95 | $0.95 | 3.47 |
During the three months ended September 30, 2026, certain warrant holders of March 2025 Private Placement Warrants elected to exercise warrants on a cashless basis in accordance with the terms of the warrant agreements with respect to such March 2025 Private Placement Warrants. As a result,75,541 of the warrants exercised were surrendered in satisfaction of the aggregate exercise price, and no shares of common stock were issued in respect of those warrants. In addition, during the three months ended September 30, 2026, certain holders of March 2025 Warrants elected to receive 4,157,895 pre-funded warrants, in lieu of shares of common stock, upon the cash exercise of 4,157,895 March 2025 Warrants. Accordingly, of the 18,507,313 warrants exercised during the nine months ended September 30, 2026,14,273,877 were settled in shares of common stock (as reflected in the condensed consolidated statements of changes in convertible preferred stock and stockholders’ equity (deficit)),4,157,895 were settled in pre-funded warrants, and 75,541 were surrendered in connection with cashless exercises.
The following table summarizes information about warrants outstanding at September 30, 2026:
| Exercise Price · Number Outstanding · Weighted AverageRemaining ContractualTerm (Years) · Number Exercisable atSeptember 30,2026 | ||||||
|---|---|---|---|---|---|---|
| $0.95 | 2,859,105 | 3.47 | 2,859,105 | * | ||
| Total | 2,859,105 | 2,859,105 | ||||
*Liability classified warrants in connection with March 2025 Financings
The above tables exclude 20,167,823 pre-funded warrants with a nominal exercise price of $0.0001 per share, consisting of 8,832,895 pre-funded warrants issued in connection with the March 2025 Offering,7,177,033 pre-funded warrants issued in connection with the November 2025 Registered Direct Offering, and 4,157,895 pre-funded warrants issued during the third quarter of 2026 upon the exercise of March 2025 Warrants with an exercise price of $0.95. All outstanding pre-funded warrants were deemed outstanding common stock for net loss per share purposes (see Note 13 – Net Loss per Share).
- Stock-based Compensation
Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying condensed consolidated statements of comprehensive loss for thethree and nine month periods indicated below (in thousands):
| Three MonthsEndedSeptember 30, | Nine MonthsEndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $577 | $249 | $1,374 | $815 |
| General and administrative | 1,013 | 567 | 3,087 | 1,810 |
| Total stock-based compensation | $1,590 | $816 | $4,461 | $2,625 |
Stock Options
During the three and nine months ended September 30, 2026,310,000 and 1,425,000 stock options were granted, respectively, to directors, officers, and employees. The weighted average grant date fair value of the stock options granted during the three and nine months ended September 30, 2026 was$2.57 and$2.87, respectively.
During the three and nine months ended September 30, 2025,733,448 and 2,793,277 stock options were granted, respectively, to directors, officers and employees. The weighted average grant date fair value of the stock options granted during the three and nine months ended September 30, 2025 was$0.79 and$0.68, respectively.
Restricted Stock Units
During the three and nine months ended September 30, 2026, the Company granted an aggregate ofzero and 3,172,708 RSUs, respectively, to directors, officers, and employees. The weighted average grant date fair value of the RSUs granted during the three and nine months ended September 30, 2026 waszero and$2.65, respectively.
During the three and nine months ended September 30, 2025, the Company granted an aggregate of 200,000 and 1,655,361 RSUs, respectively, to directors, officers, and employees. The weighted average grant date fair value of the RSUs granted during the three and nine months ended September 30, 2025 was$1.33 and$0.99, respectively.
Common Stock Issued for Services
The Company granted zero and 118,465 common shares for services during thethree and nine months ended September 30, 2026, respectively, andzero and 84,243 common shares during thethree and nine months ended September 30, 2025, respectively. The awards were granted to members of the Board who elected to receive their Board compensation in the form of stock for services. The weighted average fair value of the shares granted waszero and$2.01 per share during thethree and nine months ended September 30, 2026, respectively, andzero and$1.26 per share during thethree and nine months ended September 30, 2025, respectively. The shares were fully vested upon issuance.
- 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 was APX3330, which the Company had been developing as an oral tablet therapeutic to treat diabetic retinopathy. 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.
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. The Apexian Sublicense Agreement remained in effect until its termination on July 10, 2026, as described below.
On March 16, 2026, the Company entered into a termination and IP assignment agreement (the “Termination and IP Assignment Agreement”) with Apexian that provided for the termination of the Apexian Sublicense Agreement and the sale and assignment of certain patents, know-how, materials and regulatory assets related to the Company’s legacy APX-2009, APX-2014 and APX-3330 programs. The effectiveness of the agreement and the closing of the contemplated transactions were conditioned upon, among other things, the Company’s receipt of a non-refundable upfront payment.
On July 10, 2026, the Company received the non-refundable upfront payment, and the transaction closed. Upon closing, the related patents, know-how, materials and regulatory assets associated with the APX-2009, APX-2014 and APX-3330 programs were transferred to Apexian in accordance with the agreement.
The Company recognized the upfront payment in other income, net, in its condensed consolidated statements of comprehensive loss for the three and nine months ended September 30, 2026.
Through the termination of the Apexian Sublicense Agreement on July 10, 2026, none of the milestone or royalty payments under the agreement had been triggered. Following the termination, the Company has no further milestone or royalty payment obligations under the agreement.
- License and Collaboration Revenue and Other Funding Agreements
Viatris License Agreement
On November 6, 2022, the Company entered into the Viatris License Agreement, pursuant to which it granted Viatris an exclusive, perpetual, sub-licensable license to develop, manufacture, import, export and commercialize (i) PS, for treating (a) reversal of mydriasis, (b) night vision disturbances or dim light vision, and (c) presbyopia, and (ii) PS and low dose pilocarpine for treating presbyopia (together, the “PS Products”) worldwide except for certain countries and jurisdictions in Asia (the “Viatris Territory”). The Company retains the exclusive right to develop, manufacture, have manufactured, import, export and commercialize the PS Products outside of the Viatris Territory.
Under the terms of the Viatris License Agreement, the Company, in partnership with Viatris, will develop the PS Products in the United States. Viatris will reimburse the Company for agreed-to budgeted costs related to the development of the PS Products through FDA approval and then share costs above the agreed upon threshold amount. Viatris will be responsible for developing the PS Products in countries and jurisdictions in the Viatris Territory outside of the United States. In addition, in August 2025, Opus and Viatris entered into a side letter to the Viatris License Agreement providing for the sharing of expenses arising in connection with a patent dispute.
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 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. On October 16, 2026, the FDA’s approval of PS for the treatment of presbyopia in adults triggered a regulatory milestone payment due to the Company (see Note 16 – Subsequent Events). 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 identifiedtwo distinct performance obligations at the effective date: (1) the license to its intellectual property 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 initial research and development services that were constrained to the 120-day non-cancellation period were to be recognized over time as the services were rendered based on an estimated percentage of completion input model. The initial research and development services were completed in the first quarter of 2023. Revenue related to the on-going research and development services are based on activities completed during the period.
Recognition of Revenue
Revenue recognized under the Viatris License Agreement during the three and nine months ended September 30, 2026 was $1.1 million and $4.0 million, respectively. Revenue recognized under the Viatris License Agreement during the three and nine months ended September 30, 2025 was$3.1 million and$10.3 million, respectively, related to the output of ongoing research and development services and to a much lesser extent royalty payments. The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable and supportable forecasts. The Company has not incurred any bad debt expense to date and no allowance for credit losses has been recorded during the periods presented.
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 RYZUMVI) 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 recognizes revenues for each once a sale of a licensed product (achievement of each) occurs.
Each of the remaining regulatory and sales milestone performance obligations (aside from the $10 million milestone payment related to the FDA’s approval of PS in the third quarter of 2023) were constrained as of September 30, 2026 andno revenue was recognized related to these milestones. On October 16, 2026, the FDA approved the supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults, which triggered an additional regulatory milestone payment under the Viatris License Agreement. As a result of the approval, the uncertainty associated with this milestone was resolved, and the Company expects to recognize the milestone payment as revenue during the fourth quarter of 2026. See Note 16 – Subsequent Events.
A reconciliation of the closing balance of the contract assets and unbilled receivables associated with the Viatris License Agreement is as follows as of September 30, 2026 and 2025 (in thousands):
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Contract assets and unbilled receivables | ||
| Balance as of beginning of nine-month period | $1,170 | $2,209 |
| Revenue recognized | 4,049 | 10,331 |
| Reclassification to Accounts receivable related to costs billed under the Viatris License Agreement | (4,591) | (11,176) |
| Balance as of end of nine-month period | $628 | $1,364 |
BioSense License and Assignment
On March 10, 2020, prior to the Rexahn Merger, Rexahn entered into an amendment to its collaboration and license agreement, (as amended, the “BioSense License and Assignment Agreement”) with BioSense Global LLC (“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 $84.5 million upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties at low double-digit rates on annual net sales in the BioSense Territory. The Company determined that none of the milestone payments under the BioSense License and Assignment Agreement were probable of payment as of September 30, 2026, and as a result, no revenue related to the milestones was recognized, as the achievement of events entitling the Company to any milestone payments were highly susceptible to factors outside of the Company’s control. Future sales-based royalties related to the exclusive license to develop RX-3117, if any, will be recognized in the period the underlying sales transaction occurs.
Payments received under the BioSense License and Assignment Agreement will be subject to the CVR Agreement described in Note 4 – Commitments and Contingencies.
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.
Pursuant to the agreement, Processa was obligated to make future payments to the Company upon the achievement of certain development, regulatory and commercial milestones. In addition, Processa was obligated to pay the Company mid-single-digit percentage royalties based on annual sales.
On June 27, 2025, Processa notified the Company that it would not be developing RX-3117 and terminated the Processa License Agreement, effective October 25, 2025(the “Termination Date”). No payments were received under the Processa License Agreement prior to the Termination Date, and no further payments will be received.
SBIR Grant Agreements
In September 2025, the Company received a Small Business Innovation Research (“SBIR”) grant through the Department of Health and Human Services of up to $1.7 million to be used on the development of the RHO product. In September 2026, the Company received two additional SBIR grants, one for the development of the RDH12 program of up to $2.1 million and one for the development of the NMNAT1 program of up to $2.0 million (collectively with the September 2025 grant, the “SBIR Grant Agreements”). Direct and allocated indirect costs for development activities under the SBIR Grant Agreements are reimbursed on a draw-down basis as development activities are completed. For the three and nine months ended September 30, 2026, the Company recognized$0.2 million and$0.9 million, respectively, of income related to the SBIR Grant Agreements. For the three and nine months ended September 30, 2025, the Company recognized$0.1 million and $0.3 million, respectively, of income related to the RHO SBIR grant agreement. The amounts are recorded as other income, net in the accompanying condensed consolidated statements of comprehensive loss.
RDH12 Agreement
On July 22, 2025, the Company, together with its wholly owned subsidiary, OpusTX, LLC (collectively, “Opus”), entered into a funding and license agreement (the “RDH12 Agreement”) with Eyes on the Future (“EOTF”), and RDH12 Fund for Sight (the “Fund,” and together with EOTF, the “Funding Parties”), charitable organizations, relating to Opus’ program to develop gene therapies that treat patients with inherited retinal degeneration associated with mutations in the RDH12 gene (the “RDH12 Program”). The RDH12 Agreement provides for funding by the Funding Parties of up to $1.6 million to support the development of the RDH12 Program. Opus is required to use the funding to conduct development activities in accordance with a mutually agreed development plan.
Under the RDH12 Agreement, Opus is subject to certain diligence obligations to develop a product under the RDH12 Program. If Opus is unable to achieve certain milestones by the specified dates, or if certain other events occur (a “License Trigger Event”), then the Funding Parties may exercise their rights under a non-exclusive, global, royalty-free and fully paid-up license granted by Opus to the Funding Parties to develop products under the RDH12 Program. If the Funding Parties exercise such license rights, then Opus will receive a non-exclusive license under the data and other intellectual property generated by the Funding Parties to develop products under the RDH12 Program, and the right to negotiate an exclusive license to such data and intellectual property to commercialize products under the RDH12 Program. The RDH12 Agreement includes certain restrictions on Opus’ ability to out-license rights to the RDH12 Program, and during the term of the RDH12 Agreement, Opus may not grant a third party an exclusive license to develop or commercialize products under the RDH12 Program in the United States without the prior written consent of the Funding Parties.
The term of the RDH12 Agreement continues until the earlier of (a) dosing by Opus of three patients in a Phase 1a/2b clinical trial prior to a License Trigger Event, and (b) the first commercial sale of a product under the RDH12 Program following receipt of regulatory approval in the United States or certain European countries. The RDH12 Agreement will also terminate if an exclusive, global licensee of Opus for the RDH12 Program assumes Opus’ obligations under the RDH12 Agreement. The RDH12 Agreement may be terminated by either party for cause, including material breach or bankruptcy, subject to a cure period, or by the Funding Parties for convenience following a License Trigger Event.
Eligible research and development costs under the RDH12 Agreement, as approved by the Funding Parties, are reimbursed on a draw-down basis as development activities are completed by the Company. For the three and nine months ended September 30, 2026, the Company recognized less than$0.1 million and$0.8 million, respectively, of income related to reimbursements under the RDH12 Agreement, which was recorded in other income, net, in the accompanying condensed consolidated statements of comprehensive loss. No income was recognized related to the RDH12 Agreement during the three and nine months ended September 30, 2025.
- Net Loss per Share
Basic net loss 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. For purposes of calculating basic net loss per share, the weighted-average number of common shares outstanding includes the weighted average effect of the pre-funded warrants issued in March 2025, November 2025 and September 2026, the exercise of which requires little or no consideration for the delivery of shares of common stock. Accordingly, the pre-funded warrants are not included in the table below of anti-dilutive securities. Diluted net loss per share is computed similarly to basic net loss per share, except that the denominator is increased to include potential common shares if their effect is dilutive. The Company's outstanding warrants (other than the pre-funded warrants), stock options, RSUs and Conversion Shares are potential common stock equivalents. The treasury stock method is used for warrants, stock options and RSUs, and the if-converted method is used for Conversion Shares. The Series B preferred stock converted into common stock on April 23, 2026; the common shares issued upon conversion are included in the weighted-average common shares outstanding from the conversion date, and the incremental effect of assumed conversion for the pre-conversion period was excluded because the conditions for conversion had not been met. No other incremental common stock equivalents were included because their inclusion would have been anti-dilutive.
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 thethree and nine month periods presented below:
| September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Warrants | 2,859,105 | 29,433,401 |
| Stock options | 7,859,320 | 7,218,064 |
| RSUs | 4,026,978 | 2,409,231 |
| Conversion shares | 530,517 | — |
| Total | 15,275,920 | 39,060,696 |
- Income Taxes
The effective tax rate for the three and nine months ended September 30, 2026 and 2025 waszero percent. As of September 30, 2026, 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 2021 for federal income tax purposes and subject to examination in various state jurisdictions beginning in 2020. The Company does not have any reserves for income taxes that represent the Company’s potential liability for uncertain tax positions.
- Deferred Compensation Plan
Effective October 1, 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 thefirst 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 thethree months ended September 30, 2026 and 2025, the Company contributed$0.1 million and less than$0.1 million to the 401K Plan, respectively. During thenine months ended September 30, 2026 and 2025, the Company contributed$0.3 million and$0.1 million to the 401K Plan, respectively.
- Subsequent Events
Phentolamine Ophthalmic Solution 0.75% sNDA Approval
On October 16, 2026, the FDA approved the Company’s supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults. Under the Company’s global license and collaboration agreement with Viatris, this regulatory approval triggered a milestone payment due to the Company. The Company is also eligible to receive tiered royalties on net sales of PS for the treatment of presbyopia in accordance with the terms of the Viatris License Agreement (see Note 12 – License and Collaboration Revenue and Other Funding Agreements).
March 2025 Warrants Call Notice
On October 22, 2026, the Company delivered call notices to the holders of all 2,859,105 March 2025 Warrants outstanding at September 30, 2026, as disclosed above. The Company exercised its right to call the March 2025 Warrants pursuant to the terms of the warrant agreement following the announcement of OPGx-BEST1 BIRD-1 Cohort 1 data on September 9, 2026 and the satisfaction of the specified stock price and trading volume conditions. Holders may exercise their March 2025 Warrants for cash at the exercise price of $0.95 per share until 6:30 p.m., New York City time, on December 4, 2026. Any March 2025 Warrants that remain unexercised after that time will be cancelled, and the holders will be entitled to receive $0.001 per warrant share. Through the date of issuance of these condensed consolidated financial statements, a total of 2,078,947 of the remaining 2,859,105 March 2025 Warrants had been exercised, resulting in proceeds of $2.0 million.
RDF Agreement Funding
On November 4, 2026, the Company received an additional $0.7 million of funding under the RDF Agreement described in Note 6 – Related Party Transactions, bringing total funding received under the RDF Agreement to $1.7 million.
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