Opus Genetics, Inc.

Previous wording

Certain statements contained in this Report are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance. Such statements include, but are not limited to, statements concerning our strategic business plans, the applications of our product candidates, ongoing discussions with the U.S. Food and Drug Administration (the “FDA”) regarding various of our drug products, and continued drug development and commercialization under our agreement with Viatris, Inc. (“Viatris”). In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “could,” “continue,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements.

Current wording

Certain statements contained in this Report are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance. Such statements include, but are not limited to, statements concerning our strategic business plans and outlook; the applications, design, potential benefits and market opportunity of our product candidates, including our estimates of patient populations and disease prevalence; our expectations regarding the potential market acceptance and commercial success of our product candidates, if approved; the timing, design, enrollment, progress and results of our ongoing and planned preclinical studies and clinical trials, including the expected timing of patient dosing and data readouts; our planned regulatory submissions and the potential receipt of regulatory approvals or designations; our manufacturing plans; continued drug development and commercialization under our agreement with Viatris, Inc. (“Viatris”); our other license, collaboration, grant and funding arrangements; our expected future revenue, expenses and capital requirements; the sufficiency of our cash and cash equivalents to fund our operations; our anticipated sources and uses of capital. In some cases, you can identify forward-looking statements by the following words:“aim,”“anticipate,” “believe,”“can,”“could,” “continue,”“design,”“estimate,” “expect,”“forecast,” “goal,”“intend,” “may,” “might,”“ongoing,” “plan,” “potential,” “predict,” “project,”“seek,”“should,” “target,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements, although not all forward-looking statements contain these words.

Previous wording

•The future commercial success of our products could significantly depend upon several uncertain factors, including third-party reimbursement practices and the existence of competitors with similar products;

Current wording

•The future commercial success of our products could significantly depend upon several uncertain factors, including market acceptance, third-party reimbursement practices and the success of competitors with similar products;

Previous wording

•We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, including due to government shutdowns and disruptions at government agencies, which cause delays, requires the use of additional, unforeseen resources, affects our pipeline stability, and could impair our ability to compete in international markets;

Current wording

•We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, including due to government shutdowns and disruptions at government agencies, which cause delays, require the use of additional, unforeseen resources, affect our pipeline stability, and could impair our ability to compete in international markets;

Previous wording

•As we grow, we may not be able to operate internationally or adequately develop and expand our sales, marketing, distribution, and other corporate functions, which could disrupt our operations;

Current wording

•As we grow, we may not be able to operate internationally or adequately develop our sales, marketing, distribution, and other corporate functions, which could disrupt our operations;

Previous wording

Opus Genetics, Inc. (the “Company,” “Opus,” “we,” “us,” or “our”) is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with IRDs. We also have a small molecule therapy for other ophthalmic disorders.

Current wording

Opus Genetics, Inc. (the “Company,” “Opus,” “we,” “us,” or “our”) is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (“IRDs”). We also have a small molecule therapy for other ophthalmic disorders.

Previous wording

In July 2026, we announced alignment with the FDA in a Type B RDEP meeting on the design of our registrational Phase 3 clinical trial evaluating OPGx-LCA5 in eight participants with a six-month run-in period, allowing each participant to serve as their own control, prior to receiving treatment in both eyes.

Current wording

In July 2026, we announced alignment with the FDA in a Type B RDEP meeting on the design of our registrational Phase 3 clinical trial evaluating OPGx-LCA5 in 8 participants with a six-month run-in period, allowing each participant to serve as their own control, prior to receiving treatment in both eyes.

Previous wording

In August 2026, enrollment in the trial was completed, with dosing of OPGx-LCA5 expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes.

Current wording

In August 2026, enrollment in the Phase 3 trial was completed with 8 participants and dosing of OPGx-LCA5 is expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes.

Previous wording

The intent is that data from this study will be used to submit a Biologics License Application (BLA). In addition, OPGx-LCA5 may qualify to receive a Priority Review Voucher if approved, which we believe would represent a potentially significant strategic asset.

Current wording

Topline data from the Phase 3 trial is expected by the end of 2027. The intent is that data from this study will be used to submit a Biologics License Application (BLA). In addition, OPGx-LCA5 may qualify to receive a Priority Review Voucher if approved, which we believe would represent a potentially significant strategic asset.

Previous wording

OPGx-BEST1 is being developed for the treatment of IRDs associated with mutations in the BEST1 gene. BEST1 disease, or vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and, in some cases, blindness. In preclinical studies conducted in a naturally occurring canine model of BEST1 disease, OPGx-BEST1 demonstrated restoration of the retinal pigment epithelium-photoreceptor interface using AAV-mediated gene delivery, providing evidence in support of a first-in-man clinical trial. BEST1 affects an estimated 8,400 patients in the U.S. and 21,800 globally.

Current wording

OPGx-BEST1 is being developed for the treatment of IRDs associated with mutations in the BEST1 gene. BEST1 disease, or vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and, in some cases, blindness. OPGx-BEST1 uses an AAV2 vector to deliver a functional BEST1 gene designed to target the retinal pigment epithelium (RPE) and restore bestrophin function via a single subretinal injection. In preclinical studies conducted in a naturally occurring canine model of BEST1 disease, OPGx-BEST1 demonstrated restoration of the retinal pigment epithelium-photoreceptor interface using AAV-mediated gene delivery. OPGx-BEST1 is currently being evaluated in an open-label, adaptive Phase 1/2 clinical trial.

Previous wording

In July 2026, we provided a program update and timeline for BIRD-1. In Cohort 1, the primary endpoint for evaluation is the safety and tolerability of OPGx-BEST1. In addition to safety measures, Opus will also be assessing a number of structural and functional parameters. We expect to announce three-month topline data from Cohort 1 during the second week of September 2026, assuming all participants complete their assessments as scheduled. In addition, we plan to present the data at the annual EURETINA Congress taking place in Vienna, Austria in October 2026. We also expect to present the three-month data to the FDA and meet with them as needed to align on the next steps for clinical development.

Current wording

In July 2026, we provided a program update and timeline for BIRD-1. In Cohort 1, the primary endpoint for evaluation is the safety and tolerability of OPGx-BEST1. In addition to safety measures, Opus will also be assessing a number of structural and functional parameters.

Previous wording

We are advancing OPGx-RDH12 to deliver a functional RDH12 gene to photoreceptors using an AAV vector. Preclinical studies in cellular and mouse models have demonstrated restoration of RDH12 activity and functional improvement. This program is expected to enter the clinic in the fourth quarter of 2026 and is partially funded through a partnership with the RDH12 Alliance.

Current wording

We are advancing OPGx-RDH12 to deliver a functional RDH12 gene to photoreceptors using an AAV vector. Preclinical studies in cellular and mouse models have demonstrated restoration of RDH12 activity and functional improvement. In October 2026, the FDA cleared our IND application for OPGx-RDH12, enabling us to advance the program into clinical development. OPGx-RDH12 is expected to enter the clinic in the fourth quarter of 2026 and is partially funded through a partnership with the RDH12 Alliance.

Previous wording

Global patient prevalence estimates are from an analysis of key markets including the United States, EU4 (France, Spain, Germany, & Italy), United Kingdom, Middle East/North Africa, and China, which was completed in February 2026 by Triangle Insights Group.

Current wording

Global patient prevalence estimates are from a February 2026 analysis of key markets, including the United States, EU4 (France, Spain, Germany, & Italy), United Kingdom, Middle East/North Africa, and China.

Previous wording

Our pipeline also includes Phentolamine Ophthalmic Solution 0.75% (PS), a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, administered as an eye drop. It aims to work by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors. PS is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents. PS is targeting three different indications.

Current wording

Our pipeline also includes Phentolamine Ophthalmic Solution 0.75% (PS), a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, administered as an eye drop. It aims to work by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors. PS is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents. PS is approved in the United States for two indications, the reversal of pharmacologically-induced mydriasis and, as of October 2026, the treatment of presbyopia in adults, and is being developed for a third indication, decreased vision under mesopic (low) light conditions following keratorefractive surgery.

Previous wording

In November 2022, we entered into a license and collaboration agreement (as amended, the “Viatris License Agreement”) with Viatris, Inc. (“Viatris”), pursuant to which we granted Viatris an exclusive license to develop, manufacture, import, export and commercialize PS for treating (a) reversal of pharmacologically-induced mydriasis, (b) decreased vision under mesopic (low) light conditions after keratorefractive surgery, 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. For more information on the Viatris License Agreement, please refer to Note 12 – License and Collaboration Agreements and Other Funding Agreements included in Part I, Item 1– Financial Statements and Supplementary Data of this Report.

Current wording

In November 2022, we entered into a license and collaboration agreement (as amended, the “Viatris License Agreement”) with Viatris, Inc. (“Viatris”), pursuant to which we granted Viatris an exclusive license to develop, manufacture, import, export and commercialize (i) PS for treating (a) reversal of pharmacologically-induced mydriasis, (b) decreased vision under mesopic (low) light conditions after keratorefractive surgery, 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. For more information on the Viatris License Agreement, please refer to Note 12 – License and Collaboration Revenue and Other Funding Agreements included in Part I, Item 1– Financial Statements of this Report.

Previous wording

RYZUMVI® (phentolamine ophthalmic solution) 0.75%: PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI® in September 2023, which triggered a $10 million milestone payment under the Viatris License Agreement. RYZUMVI was commercialized by Viatris in April 2024.

Current wording

RYZUMVI® (phentolamine ophthalmic solution) 0.75%: PS was approved by the FDA for the treatment of pharmacologically-induced mydriasis under the brand name RYZUMVI® in September 2023, which triggered a $10 million milestone payment under the Viatris License Agreement. RYZUMVI was commercialized by Viatris in April 2024. In October 2026, the FDA approved the supplemental New Drug Application for RYZUMVI for the treatment of presbyopia in adults, expanding the product's approved indications. The approval triggered a milestone payment due to us under the Viatris License Agreement.

Previous wording

On April 2, 2026, we entered into a senior secured note purchase agreement (as amended from time to time, the "Note Purchase Agreement") with affiliates of Oberland Capital Management LLC (collectively,“Oberland Capital”). The proceeds of the financing may be used for general corporate purposes of the Company, which includes uses to accelerate the clinical development, manufacturing, and potential commercialization of our broad IRD gene therapy pipeline.

Current wording

On April 2, 2026, we entered into a senior secured note purchase agreement (as amended from time to time, the“Note Purchase Agreement”) with affiliates of Oberland Capital Management LLC (collectively,“Oberland Capital”). The proceeds of the financing may be used for general corporate purposes, including to accelerate the clinical development, manufacturing, and potential commercialization of our broad IRD gene therapy pipeline.

Previous wording

The Note Purchase Agreement provides us with access to future non-dilutive funding of up to $155.0 million to support our future strategic initiatives and growth, with an initial tranche of $35.0 million, which was funded on April 21, 2026, the First Purchase Date, a second $35.0 million tranche available at our option (subject to satisfaction of customary funding conditions) until April 2, 2027, along with additional tranches up to $35.0 million available to us upon the occurrence of certain milestones and satisfaction of customary funding conditions. The Note Purchase Agreement also provides for up to $50.0 million in additional tranches at the mutual agreement of the parties. See further details in Note 7– Debt andthe Liquidity and Capital Resources section below under Historical Capital Resources.

Current wording

The Note Purchase Agreement provides us with access to future funding of up to $155.0 million to support our future strategic initiatives and growth, with an initial tranche of $35.0 million of senior secured notes (the “Notes”), which was funded on April 21, 2026 (the “First Purchase Date”), a second $35.0 million tranche available at our option (subject to satisfaction of customary funding conditions) until April 2, 2027, along with additional tranches of up to $35.0 million available to us upon the occurrence of certain milestones and satisfaction of customary funding conditions. The Note Purchase Agreement also provides for up to $50.0 million in additional tranches upon the mutual agreement of the parties. See further details in Note 7– Debt andthe Liquidity and Capital Resources section below under Historical Capital Resources.

Previous wording

Concurrently with the Note Purchase Agreement, we entered into a Purchase and Conversion Agreement with the Purchasers, providing for the issuance of an aggregate of 1,116,070 shares of our common stock at a price per share equal to $4.48, for an aggregate purchase price of $5.0 million. See further details in Note 9– Financings andthe Liquidity and Capital Resources section below under Historical Capital Resources.

Current wording

Concurrently with the Note Purchase Agreement, we entered into a stock purchase and conversion agreement (the “Purchase and Conversion Agreement”) with the purchasers of the Notes (the “Purchasers”), providing for the issuance of an aggregate of 1,116,070 shares of our common stock (the “Purchase Shares”) at a price per share equal to $4.48 (the “Per Share Purchase Price”), for an aggregate purchase price of $5.0 million. See further details in Note 9– Financings andthe Liquidity and Capital Resources section below under Historical Capital Resources.

Previous wording

The Note Purchase Agreement and Purchase and Conversion Agreement were amended on April 13, 2026. The amendment revised the Per Share Purchase Price to the lower of $4.48 per share or a 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 updated the expected issuance of the Purchase Shares to be on or about May 22, 2026, subject to the satisfaction of customary closing conditions.

Current wording

The Note Purchase Agreement and Purchase and Conversion Agreement were amended on April 13, 2026. The 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 and revised the Notes conversion price to the lower of $6.72 or 150% of the Per Share Purchase Price. The issuance of the Purchase Shares closed on May 26, 2026, resulting in the issuance of 1,116,070 shares of our common stock for aggregate gross proceeds of $5.0 million.

Previous wording

On February 13, 2026, we entered into a securities purchase agreement with certain investors for a private placement of 7,374,632 shares of Series B preferred stock 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. The Series B preferred stock was convertible into shares of our common stock on a one‑for‑one basis, subject to stockholder approval of an increase in the Company’s authorized common stock and certain beneficial ownership limitations.

Current wording

On February 13, 2026, we entered into a securities purchase agreement with certain investors for a private placement of 7,374,632 shares of Series B preferred stock 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. The Series B preferred stock was convertible into shares of our common stock on a one‑for‑one basis, subject to stockholder approval of an increase in our authorized common stock and certain beneficial ownership limitations.

Previous wording

During the three and six months ended June 30, 2026, we sold 1,000,000 shares of common stock under the Leerink ATM program (as defined and described further below in the Liquidity and Capital Resources section under Historical Capital Resources)for gross proceeds of $2.3 million, before deducting issuance expenses. Total issuance expenses, including sales agent fees and legal and accounting expenses, were $0.1 million for the three and six months ended June 30, 2026.

Current wording

On August 6, 2026, we entered into a new sales agreement (the “New Sales Agreement”) with Leerink Partners LLC (“Leerink”) and Cantor Fitzgerald & Co. (“Cantor”) in connection with a new at-the-market equity offering program (the “New ATM Program”), under which we may offer and sell shares of our common stock having an aggregate offering price of up to $125.0 million. The New ATM Program became available following the effectiveness of our Form S-3 on August 14, 2026, and replaced our prior at-the-market equity offering program with Leerink (the “Prior ATM Program”). During the nine months ended September 30, 2026, we sold 1,000,000 shares of common stock under the Prior ATM Program (all of which were sold during the three months ended March 31, 2026) for gross proceeds of $2.3 million, before deducting issuance expenses. Total issuance expenses, including sales agent fees and legal and accounting expenses, were $0.1 million for the nine months ended September 30, 2026. We did not sell any shares under the New ATM Program during the three and nine months ended September 30, 2026. See Note 9 – Financings and the Liquidity and Capital Resources section below under Historical Capital Resources.

Previous wording

Our net loss was $8.1 million and $73.6 million for the three and six months ended June 30, 2026, as compared to a net loss of $7.4 million and $15.6 million for the three and six months ended June 30, 2025. As of June 30, 2026, we had an accumulated deficit of $262.2 million. We anticipate that our expenses will continue to increase as we:

Current wording

Our net loss was $46.5 million and $120.1 million for the three and nine months ended September 30, 2026, as compared to a net loss of $17.5 million and $33.1 million for the three and nine months ended September 30, 2025. As of September 30, 2026, we had an accumulated deficit of $308.7 million. We anticipate that our expenses will continue to increase as we:

Previous wording

Our net loss will likely continue to fluctuate significantly from quarter to quarter and year to year, depending on fair value adjustments related to our liability classified warrants, the timing of our nonclinical studies, clinical trials, expenditures on other research and development activities (and reimbursement thereof), and from potential milestone payments received from and revenue earned under the Viatris License Agreement or any other license and collaboration agreements that we enter into.

Current wording

Our net loss will likely continue to fluctuate significantly from quarter to quarter and year to year, depending on fair value adjustments related to the Notes, the timing of our nonclinical studies, clinical trials, expenditures on other research and development activities (and reimbursement thereof), and from potential milestone payments received from and revenue earned under the Viatris License Agreement or any other license and collaboration agreements that we enter into.

Previous wording

License and collaborations revenue to date was derived from a one-time, non-refundable payment related to a license transfer, an additional milestone payment and reimbursement of expenses earned under the Viatris License Agreement, and to a much lesser degree, from license agreements with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc. (“Processa”). We anticipate that we will recognize revenue as we earn reimbursement for research and development services in connection with the Viatris License Agreement, up to a cap of$50.0 million, and we may earn additional revenues from potential milestone and royalty payments from the agreements with Viatris or from other license agreements entered into the future; however, the attainment of milestones or level of sales required to earn significant royalty payments is highly uncertain for the reasons explained below. Until further notice, we will report earned RYZUMVI® royalties as a component of license and collaboration revenue listed in the consolidated statements of comprehensive loss.

Current wording

License and collaborations revenue to date was derived from a one-time, non-refundable payment related to a license transfer, an additional milestone payment and reimbursement of expenses earned under the Viatris License Agreement, and to a much lesser degree, from license agreements with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc. (“Processa”). We anticipate that we will recognize revenue as we earn reimbursement for research and development services in connection with the Viatris License Agreement, up to a cap of$50.0 million, and we may earn additional revenues from potential milestone and royalty payments from the agreements with Viatris or from other license agreements entered into in the future; however, the attainment of milestones or level of sales required to earn significant royalty payments is highly uncertain for the reasons explained below. Until further notice, we will report earned RYZUMVI® royalties as a component of license and collaboration revenue in the condensed consolidated statements of comprehensive loss.

Previous wording

To date, outside of the license and collaborations revenue referenced above, we do not expect to generate significant revenue unless or until RYZUMVI® sales become material, or regulatory approval is obtained, and commercialization begins for LCA5, BEST1, other internally-developed assets or PS for additional indications. If we fail to complete the development of LCA5, BEST1, PS, or any other product candidate we may pursue or fail to obtain regulatory approval, our ability to generate significant revenue will be compromised.

Current wording

To date, outside of the license and collaborations revenue referenced above, we do not expect to generate significant revenue unless or until RYZUMVI® sales become material, or regulatory approval is obtained, and commercialization begins for LCA5, BEST1, other internally-developed assets or PS for additional indications. In October 2026, the FDA approved PS for the treatment of presbyopia in adults, which triggered a milestone payment due to us under the Viatris License Agreement and expands the indications on which royalties may be earned. If we fail to complete the development of LCA5, BEST1, PS, or any other product candidate we may pursue or fail to obtain regulatory approval, our ability to generate significant revenue will be compromised.

Previous wording

Provision for income taxes consists of federal and state income taxes in the United States, as well as deferred income taxes and changes in related valuation allowance reflecting the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Currently, a full valuation allowance has been provided on the net deferred tax assets as of June 30, 2026 and December 31, 2025 given the uncertainty of future taxable income and other related factors impacting the realizability or our remaining net deferred tax assets.

Current wording

Provision for income taxes consists of federal and state income taxes in the United States, as well as deferred income taxes and changes in related valuation allowance reflecting the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Currently, a full valuation allowance has been provided on the net deferred tax assets as of September 30, 2026 and December 31, 2025 given the uncertainty of future taxable income and other related factors impacting the realizability of our remaining net deferred tax assets.

Previous wording

License and collaborations revenue was$0.8 million and$2.9 million for the three months ended June 30, 2026 and 2025, respectively. Revenue during both quarterly periods was derived from the Viatris License Agreement, primarily for the reimbursement of research and development services, and to a much lesser extent, earned royalties from sales of RYZUMVI, indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents by our commercial partner. The$2.1 million decrease in license and collaborations revenue during the current three month period ended June 30, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

Current wording

License and collaborations revenue was$1.1 million and$3.1 million for the three months ended September 30, 2026 and 2025, respectively. Revenue during both quarterly periods was derived from the Viatris License Agreement, primarily for the reimbursement of research and development services, and to a much lesser extent, earned royalties from sales of RYZUMVI, indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents by our commercial partner. The$1.9 million decrease in license and collaborations revenue during the three month period ended September 30, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

Previous wording

Research and development expenses for the six months ended June 30, 2026 were$21.8 million compared to$14.0 million for the six months ended June 30, 2025. The$7.8 million increase was primarily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs of $7.9 million and $1.5 million, respectively, as development progresses, partially offset by lower clinical costs associated with the PS related programs of $3.7 million as clinical trials near completion. Additionally contributing to the change period over period was an increase of $1.4 million in discovery costs related to IRD programs and an increase of $0.7 million in employee compensation costs. Research and development expenses included $0.8 million and $0.6 million in stock-based compensation expense for the six months ended June 30, 2026 and 2025, respectively.

Current wording

Research and development expenses for the three months ended September 30, 2026 were$14.5 million compared to$6.4 million for the three months ended September 30, 2025. The$8.1 million increase was primarily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs of $5.5 million and $1.7 million, respectively, as development progresses, partially offset by lower clinical costs associated with the PS related programs of $1.7 million due to the timing of clinical trial activities. Additional period-over-period changes included an increase of $0.9 million in discovery costs related to IRD programs and an increase of $1.9 million in employee compensation costs, partially offset by a decrease of $0.2 million in miscellaneous research and development costs. Research and development expenses included $0.6 million and $0.2 million in stock-based compensation expense for the three months ended September 30, 2026 and 2025, respectively.

Previous wording

General and administrative expenses for the three months ended June 30, 2026 were$6.0 million compared to$5.8 million for the three months ended June 30, 2025. The increase of$0.2 million was primarily attributable to higher employee compensation costs of $0.7 million, partially offset by lower public company related costs of $0.5 million. General and administrative expenses included$1.0 million and$0.6 million in stock-based compensation expense during the three months ended June 30, 2026 and 2025, respectively.

Current wording

General and administrative expenses for the three months ended September 30, 2026 were$5.9 million compared to$5.0 million for the three months ended September 30, 2025. The increase of$0.9 million was primarily attributable to higher employee compensation costs on a period-over-period basis. General and administrative expenses included$1.0 million and$0.6 million in stock-based compensation expense during the three months ended September 30, 2026 and 2025, respectively.

Previous wording

The fair value change in instruments measured at fair value was attributed to the March 2025 Warrants and March 2025 Private Placement Warrants, and to a lesser extent, the Notes remeasured at fair value on a recurring basis. The income of$7.2 million for the three months ended June 30, 2026 is due to income of$7.4 million from the warrant fair value remeasurement, partially offset by a$0.2 million charge for the fair value remeasurement of the Notes. The income of$0.9 million for the three months ended June 30, 2025 is due exclusively to the warrant fair value remeasurement. The fair value changes are attributed to the fluctuations in our common stock fair value and underlying changes in volatility, expected term and interest rates, as well as discount rate for the Notes.

Current wording

The fair value change in instruments measured at fair value was attributed to the March 2025 Warrants and March 2025 Private Placement Warrants, and to a lesser extent, the Notes remeasured at fair value on a recurring basis. The$28.6 million expense for thethree months ended September 30, 2026 consisted of$27.5 million of expense from the warrant fair value remeasurement and $1.1 million of expense from the fair value remeasurement of the Notes. The expense of$9.5 million for the three months ended September 30, 2025 is due exclusively to the warrant fair value remeasurement. The fair value changes are attributed to the fluctuations in our common stock fair value and underlying changes in volatility, expected term and interest rates, as well as discount rate for the Notes.

Previous wording

License and collaborations revenue was$2.9 million and$7.3 million for the six months ended June 30, 2026 and 2025, respectively. Revenue during the six month periods was derived from the Viatris License Agreement, primarily for the reimbursement of research and development services, and to a much lesser extent, earned royalties from sales of RYZUMVI, indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents by our commercial partner. The$4.4 million decrease in license and collaborations revenue during the current six month period ended June 30, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

Current wording

License and collaborations revenue was$4.0 million and$10.3 million for the nine months ended September 30, 2026 and 2025, respectively. Revenue during the nine month periods was derived from the Viatris License Agreement, primarily for the reimbursement of research and development services, and to a much lesser extent, earned royalties from sales of RYZUMVI, indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents by our commercial partner. The$6.3 million decrease in license and collaborations revenue during the nine month period ended September 30, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

Previous wording

A greater percentage of our research and development expense incurred has been allocated to IRD programs for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025 as we continue to focus on developing our broad IRD gene therapy pipeline. Conversely, a lesser percentage of research and development expense incurred has been allocated to PS for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.

Current wording

A greater percentage of our research and development expense incurred has been allocated to IRD programs for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025 as we continue to focus on developing our broad IRD gene therapy pipeline. Conversely, a lesser percentage of research and development expense incurred has been allocated to PS for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025.

Previous wording

Research and development expenses for the three months ended June 30, 2026 were$11.2 million compared to$6.0 million for the three months ended June 30, 2025. The$5.2 million increase was primarily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs of $3.6 million and $1.4 million, respectively, as development progresses, partially offset by lower clinical costs associated with the PS related programs of $1.8 million as clinical trials near completion. Additionally contributing to the change period over period was an increase of $1.1 million in discovery costs related to IRD programs, an increase of $0.7 million in employee compensation costs, and an increase of $0.2 million in miscellaneous research and development costs. Research and development expenses included $0.4 million and $0.3 million in stock-based compensation expense for the three months ended June 30, 2026 and 2025, respectively.

Current wording

Research and development expenses for the nine months ended September 30, 2026 were$36.3 million compared to$20.4 million for the nine months ended September 30, 2025. The$15.9 million increase was primarily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs of $13.3 million and $3.1 million, respectively, as development progresses, partially offset by lower clinical costs associated with the PS related programs of $5.5 million as clinical trials near completion. Additional period-over-period changes included an increase of $2.5 million in discovery costs related to IRD programs and an increase of $2.7 million in employee compensation costs, partially offset by a decrease of $0.2 million in miscellaneous research and development costs. Research and development expenses included $1.4 million and $0.8 million in stock-based compensation expense for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

General and administrative expenses for the six months ended June 30, 2026 were$12.0 million compared to$12.1 million for the six months ended June 30, 2025. The decrease of$0.1 million was primarily attributable to lower public company related costs and legal costs of approximately $2.0 million, partially offset by higher employee compensation related costs of $1.9 million. General and administrative expenses included$2.1 million and$1.2 million in stock-based compensation expense during the six months ended June 30, 2026 and 2025, respectively.

Current wording

General and administrative expenses for the nine months ended September 30, 2026 were$17.9 million compared to$17.1 million for the nine months ended September 30, 2025. The increase of$0.8 million was primarily attributable to higher employee compensation related costs of $2.6 million, partially offset by lower legal and public company related costs of approximately $1.8 million. General and administrative expenses included$3.1 million and$1.8 million in stock-based compensation expense during the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

The fair value change in instruments measured at fair value was attributed to the March 2025 Warrants and March 2025 Private Placement Warrants, and to a lesser extent, the Notes remeasured at fair value on a recurring basis. The expense of$44.2 million for the six months ended June 30, 2026 is due to expense of$44.0 million from the warrant fair value remeasurement, and expense of $0.2 million from the fair value remeasurement of the Notes. The income of$3.7 million for the six months ended June 30, 2025 is due exclusively to the warrant fair value remeasurement. The fair value changes are attributed to the fluctuations in our common stock fair value and underlying changes in volatility, expected term and interest rates, as well as discount rate for the Notes.

Current wording

The fair value change in instruments measured at fair value was attributed to the March 2025 Warrants and March 2025 Private Placement Warrants, and to a lesser extent, the Notes remeasured at fair value on a recurring basis. The expense of$72.8 million for the nine months ended September 30, 2026 is due to expense of$71.5 million from the warrant fair value remeasurement, and expense of $1.3 million from the fair value remeasurement of the Notes. The expense of$5.8 million for the nine months ended September 30, 2025 is due exclusively to the warrant fair value remeasurement. The fair value changes are attributed to the fluctuations in our common stock fair value and underlying changes in volatility, expected term and interest rates, as well as discount rate for the Notes.

Previous wording

Financing costs of $1.1 million for the six months ended June 30, 2026 were comprised of issuance costs attributed to the April 2, 2026 Note Purchase Agreement described further in Note 7– Debt and below in the Liquidity and Capital Resources section under Historical Capital Resources.

Current wording

Financing costs of $1.1 million for the nine months ended September 30, 2026 consisted of issuance costs attributed to the April 2, 2026 Note Purchase Agreement described further in Note 7– Debt and below in the Liquidity and Capital Resources section under Historical Capital Resources.

Previous wording

Financing costs of $1.3 million for the six months ended June 30, 2025 were comprised of issuance costs attributed to the March 2025 Warrants and March 2025 Private Placement Warrants.

Current wording

Financing costs of $1.3 million for the nine months ended September 30, 2025 consisted of issuance costs attributed to the March 2025 Warrants and March 2025 Private Placement Warrants.

Previous wording

As of June 30, 2026, our principal sources of liquidity consisted of cash and cash equivalents of$88.8 million. We believe our current available cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the date of issuance of these financial statements. As of June 30, 2026, our cash and cash equivalents were invested primarily in cash deposits and cash equivalent investments at four large financial institutions.

Current wording

As of September 30, 2026, our principal sources of liquidity consisted of cash and cash equivalents of$89.0 million. We believe our current available cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the date of issuance of these financial statements. As of September 30, 2026, our cash and cash equivalents were invested primarily in cash deposits and cash equivalent investments at four large financial institutions.

Previous wording

Our primary source of cash to fund our operations has been various equity offerings in the amount of$145.3 million, the Notes from the First Purchase Date of Note Purchase Agreement with Oberland Capital totaling $35.0 million, described further below, and the issuance of convertible notes in the amount of$8.5 million. In addition, we received a one-time non-refundable cash payment of $35.0 million during the fourth quarter of 2022, a $10.0 million milestone payment during the fourth quarter of 2023, and have received reimbursement for costs related to development since the fourth quarter of 2022 totaling $41.2 million through June 30, 2026, all in connection with the Viatris License Agreement. Lastly, we have received funding in the amount of $3.2 million from the RDF Agreement and various research and development grants.

Current wording

Our primary sources of cash to fund our operations have been equity offerings totaling$166.8 million, including proceeds from the exercise of March 2025 Warrants and March 2025 Private Placement Warrants; $35.0 million of Notes issued on the First Purchase Date under the Note Purchase Agreement with Oberland Capital, as described further below; and$8.5 million fromthe issuance of convertible notes. In addition, we received a one-time non-refundable cash payment of $35.0 million during the fourth quarter of 2022, a $10.0 million milestone payment during the fourth quarter of 2023, and have received reimbursement for costs related to development since the fourth quarter of 2022 totaling $42.1 million through September 30, 2026, all in connection with the Viatris License Agreement. Lastly, we have received funding in the amount of $3.4 million from the RDF Agreement and various research and development grants.

Previous wording

On April 2, 2026, we entered into the senior secured Note Purchase Agreement with Oberland Capital. The proceeds of the financing may be used for general corporate purposes of the Company, which includes uses to accelerate the clinical development, manufacturing, and potential commercialization of our broad IRD gene therapy pipeline. Capitalized terms used in this section but not defined herein have the meanings given to such terms in the Note Purchase Agreement.

Current wording

On April 2, 2026, we entered into the senior secured Note Purchase Agreement with Oberland Capital. The proceeds of the financing may be used for general corporate purposes, including to accelerate the clinical development, manufacturing, and potential commercialization of our broad IRD gene therapy pipeline. Capitalized terms used in this section but not defined herein have the meanings given to such terms in the Note Purchase Agreement.