Ocugen NASDAQ: OCGN used its first-quarter 2026 earnings call to highlight progress across its retinal gene therapy pipeline and to outline a strengthened balance sheet following a newly announced financing.
Convertible notes offering and cash runway outlook
Chairman, CEO, and Co-founder Dr. Shankar Musunuri opened the call by discussing the company’s $115 million offering of convertible senior notes announced the prior day. Musunuri said Ocugen expects to have $112.1 million of cash equivalents and restricted cash at closing, which includes the payoff of Avenue debt. He added that the company plans to use remaining net proceeds for general corporate purposes and expects the transaction to extend cash runway into 2028.
The offering is expected to close May 7, 2026, subject to customary conditions, and includes an option to retire the debt with a cash payment, Musunuri said. He also noted that if remaining Jones Henderson warrants are exercised, Ocugen would receive an additional $15 million in gross proceeds, increasing expected cash equivalents and restricted cash to $127.1 million.
Pipeline strategy and upcoming regulatory milestones
Musunuri positioned Ocugen’s ophthalmology programs as built on a “modified gene therapy platform” designed to be “gene-agnostic” by modulating “master regulators, nuclear hormone receptors that govern entire gene networks.” He said the company is advancing the platform across three late-stage programs—retinitis pigmentosa (RP), Stargardt disease, and geographic atrophy (GA)—which he said together affect approximately three million people across the U.S. and Europe.
Across the company’s development work, Musunuri said Ocugen has treated more than 250 patients across multiple doses and indications and has not observed a drug-related serious adverse event. He reiterated Ocugen’s goal to file three BLAs by 2028, with the first—OCU400 for RP—planned to begin rolling submission in the third quarter of 2026.
OCU400 for retinitis pigmentosa: Phase III enrollment complete, rolling BLA planned
Musunuri said the Phase III liMeliGhT trial for OCU400 is fully enrolled, with 140 patients randomized 2:1 across the RHO and gene-agnostic arms, covering over 25 genetic mutations associated with RP, including pediatric patients. The primary endpoint is 12-month change in visual function assessed by luminance dependent navigation assessment (LDNA).
Ocugen expects to initiate a rolling BLA submission in Q3 2026 and complete the full submission by Q2 2027, Musunuri said. He added that Phase III top-line data is expected in Q1 2027, and Ocugen is targeting a potential FDA approval in Q4 2027.
On manufacturing, Musunuri said process performance qualification (PPQ) batches are on track for completion in Q2 2026. In the Q&A, he told H.C. Wainwright’s Ramakanth Swayampakula the company is “on target” to complete PPQ runs in time to support the rolling BLA submission.
Musunuri also reviewed Phase I/II durability data, stating that three-year results support sustained improvement in visual function compared with untreated eyes, with clinically meaningful mean changes in low-luminance visual acuity (LLVA) at years one, two, and three. He said that at the three-year time point, 88% of treated evaluable subjects showed improvement or preservation in visual function relative to untreated eyes, and that no serious adverse events were reported as treatment-related.
In response to an Oppenheimer question on rolling submissions, Musunuri said Ocugen plans to start with the non-clinical module, followed by the CMC/manufacturing module (including PPQ lots). He said the final clinical module would be submitted next year after top-line results are available, which would start a six-month PDUFA clock.
OCU410ST for Stargardt: GARDian3 dosing completed; interim outcome analysis in Q3
Musunuri said Ocugen completed enrollment and dosing in the Phase II/III GARDian3 pivotal confirmatory trial for OCU410ST, enrolling 63 participants in less than nine months, ahead of its original timeline. The company expects an interim outcome analysis in Q3 2026, with Phase II/III data expected in Q2 2027 and a planned BLA submission by mid-2027. He said OCU410ST has shown a favorable safety and tolerability profile with no product-related serious adverse events reported to date.
Chief Medical Officer Dr. Huma Qamar said the Stargardt study includes 51 subjects in the core design (34 treatment, 17 control), with an adaptive design component described as 24 subjects (16 treatment, eight control). Qamar said the trial is “adequately powered around 90% or more,” and that the interim outcome would evaluate whether sample size re-estimation is needed.
Musunuri emphasized the Q3 review is not a typical interim efficacy readout. He described it as an adaptive-design “outcome analysis” overseen by the data monitoring committee that could result in no changes, or in adjustments such as recruiting additional patients and/or adding a longer time point (for example, extending from 12 months to 16 months) depending on predictive analytics and discussions with the FDA.
On potential launch timing, Musunuri told Maxim Group’s Michael Okunewitch that, if development proceeds as planned, RP and Stargardt approvals could be within six months of each other. He added that commercialization could benefit from overlap, since the company expects to use many of the same centers of excellence and surgeons for subretinal administration across programs.
OCU410 for geographic atrophy: Phase II data, Phase III planning, and endpoint discussions
Musunuri said Ocugen’s Phase II ArMaDa trial in GA produced positive 12-month top-line results. The study enrolled 51 patients randomized 1:1:1 to medium dose, high dose, or no treatment. Musunuri said the medium dose was optimal and showed a 31% reduction in lesion growth versus control at 12 months (P < 0.05). He also said 55% of treated subjects showed a 30% or greater reduction in lesion size relative to control, and that the company observed a 27% slower rate of ellipsoid zone (EZ) loss.
Ocugen is now working on an optimized Phase III design, including a targeted lesion size window and an adaptive design “powered at greater than 95%,” Musunuri said. He added the company expects to meet with the FDA and EMA and reach agreement on Phase III design by Q3 2026, with potential BLA filing by 2028.
In the Q&A, Musunuri provided additional Phase III design assumptions discussed for planning purposes: a 300-patient global trial across the U.S., EU, and Canada, randomized 2:1 (200 treated, 100 untreated control). He said the primary endpoint would be lesion size and the secondary endpoint would be EZ, noting power of “92% for EZ” as a secondary endpoint and that an adaptive look could occur when 150 patients reach one year.
Asked by Chardan’s Daniil Gataulin about regulators’ views on EZ preservation, Musunuri said the company had submitted meeting requests to both the FDA and EMA and would provide updates after those meetings. He reiterated that lesion growth is planned as the primary endpoint because it is used in approved U.S. products, while Ocugen is proposing EZ as a secondary endpoint because it correlates with visual function.
First-quarter financial results and spending outlook
Chief Financial Officer Rita Johnson-Greene reported total operating expenses of $19.4 million for the quarter ended March 31, 2026, including $11.3 million in R&D and $8.1 million in G&A. That compared with total operating expenses of $16.0 million in the first quarter of 2025, including $9.5 million in R&D and $6.5 million in G&A.
Ocugen posted a $0.06 net loss per common share for the quarter, compared with a $0.05 net loss per common share in the prior-year quarter, Johnson-Greene said.
Cash equivalents and restricted cash were $32.2 million as of March 31, 2026, compared with $18.9 million as of March 31, 2025. Johnson-Greene said the company received $37.5 million in gross proceeds in the first quarter of 2026, inclusive of $15 million from exercised warrants. She also reported 338.3 million shares of common stock outstanding as of March 31, 2026.
Looking ahead, Johnson-Greene told analysts the company expects to average roughly $50 million to $60 million per year in spending, and said the cash runway outlook into 2028 includes anticipated costs for the planned GA Phase III trial.
Commercialization approach and business development discussions
On commercialization planning for OCU400, Musunuri said Ocugen is working on pricing with CMS, standardizing the surgical procedure used in trials, and identifying centers of excellence for administration. He said the company expects to ramp more of the commercial build-out later in the year and into early next year.
In response to questions about centers of excellence, Musunuri said the vitrectomy procedure is not “complex” and that any of the roughly 2,400 trained retinal surgeons in the U.S. could perform it, but the company wants to ensure consistency and patient safety by training initial centers on the same surgical manual used in trials. Qamar added that no special training is required beyond standard-of-care practice, but that product-specific guidelines would apply and initial centers could help train additional sites after launch.
Johnson-Greene also said Ocugen is “actively evaluating” potential ex-U.S. business development deals for OCU400 and OCU410ST and is reviewing term sheets. For OCU410 in GA, she said the company is still looking to commercialize with a partner.
On payer dynamics, Musunuri referenced publications discussing pharmacoeconomic models and said CMS and CMMI are evaluating approaches such as subscription models and “pay over time” structures for high-priced, one-time gene therapies, which he said could help address budget constraints while expanding patient access.
About Ocugen NASDAQ: OCGN
Ocugen Inc is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing gene therapies to treat rare inherited retinal diseases, as well as vaccines designed to address unmet needs in infectious diseases. Headquartered in Malvern, Pennsylvania, the company applies its proprietary gene therapy platform to create novel treatments aimed at preserving and restoring vision, while leveraging strategic partnerships to broaden its vaccine pipeline.
In its gene therapy portfolio, Ocugen is advancing multiple programs targeting retinal disorders.
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