Ocugen (NASDAQ:OCGN) reported first-quarter financial results on Tuesday. The transcript from the company’s first-quarter earnings call has been provided below.
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View the webcast at https://edge.media-server.com/mmc/p/znywz75g/
Summary
Ocugen Inc announced a $115 million offering of convertible senior notes, expected to close on May 7, 2026, enhancing cash reserves to $112.1 million and extending cash runway into 2028.
The company is advancing its gene therapy platform across three late-stage programs targeting retinitis pigmentosa, Stargardt disease, and geographic atrophy, with plans to file three BLAs by 2028.
Financially, Ocugen Inc reported an increase in operating expenses to $19.4 million for Q1 2026, with a net loss of $0.06 per share, and cash equivalents of $32.2 million as of March 31, 2026.
Notable progress includes completing enrollment in late-stage programs, positive phase 2 data for OCU410 in geographic atrophy, and preparations for a rolling BLA submission for OCU400 in the third quarter of 2026.
Management emphasized strategic partnerships for commercialization, especially for OCU410GA, and is exploring creative pricing models with payers to facilitate market access.
Full Transcript
OPERATOR
Good morning and welcome to Ocugen Inc’s first quarter 2026 financial results and business update. All participants line are currently in listen only mode. Following the speaker commentary there will be a question and answer session. I will now turn the call over to Tiffany Hamilton, Oxygen Head of Corporate Communications. You may now begin.
Tiffany Hamilton (Head of Corporate Communications)
Thank you Operator and good morning everyone. Joining me on today’s call and webcast is Dr. Shankar Muhsinuri, Ocugen Inc’s chairman, CEO and co founder who will provide a business update and an overview of our clinical and operational progress. Rita Johnson Green, our Chief Financial Officer, is also on the call to provide a financial update for the quarter ended March 31, 2026. Dr. Huma Kumar, Chief Medical Officer, will be available to answer questions following the presentation. This morning we issued a press release covering our business and operational highlights for the first quarter 2026. We encourage listeners to review the press release which is available on our website at ocugen.com A replay of this call along with the accompanying slide presentation will be available on the Investors section of the Ocugen website. Before we begin, please note that certain statements made during today’s discussion may be forward looking in nature, including those related to our clinical development pipeline, regulatory pipelines, commercialization strategy and financial information, and our anticipated Cash Runway. These statements reflect management’s current expectations and are inherently subject to risks, uncertainties and assumptions that may cause actual results to differ materially from those expressed or implied. We encourage you to review our filings with the securities and Exchange Commission, including the risk factors detailed therein, for a more comprehensive understanding of these potential risks. Finally, Ocugen Inc’s quarterly report on Form 10Q covering the first quarter of 2026 will be filed today. I will now turn the call over to Dr. Moosunuri.
Shankar Muhsinuri
Thank you Tiffany and good morning everyone. Before I walk through the quarter, I want to discuss the 115 million offering of convertible senior notes that we announced yesterday. With the recent offering, the Company is expected to have cash cash equivalents and restricted cash off 112.1 million at closing, which includes the revenue debt payoff. The Company will use the remaining net proceeds for general corporate purposes and expects to extend cash Runway into 2028. The offering is expected to close on May 7, 2026 subject to customary closing conditions and includes an option to retire the debt with a cash payment. If the remaining Janus Henderson warrants are exercised, the Company will receive an additional 15 million in gross proceeds, increasing expected cash, cash equivalent and restricted cash to $127.1 million. Now I would like to step back because Ocugen Inc’s potential is worth putting into context. For more than a decade gene therapy in ophthalmology has been confined to a single gene, a single mutation and a single small patient population. Our modifier gene therapy platform takes a fundamentally different approach. Rather than targeting individual mutations, it is designed to address the root cause of complex retinal diseases with modulating master regulators, nuclear hormone receptors that govern entire gene networks. The platform is gene agnostic, inherently multifactorial and designed to deliver durable benefit from a single one time subretinal injection. What this means in practice is that oxygen is not building three separate drugs. We’re advancing one platform across three late stage programs, each targeting a major cause of blindness for which patients today have either no approved treatment whatsoever are therapies that demand chronic injections and carry meaningful safety burdens. Retinas pigmentosa or rp, Stargardt disease and geographic atrophy or GA together affect approximately 3 million people across the United States and Europe, a combined patient population and a commercial opportunity far larger than anything currently served by approved gene therapies and ophthalmology. Across our pipeline spanning phase one through phase three, we have treated more than 250 patients across multiple doses and indications and we have not observed a drug related serious adverse events. In our Most recent readout, OCU410 demonstrated approximately twice the treatment benefit over currently approved therapies in GA delivered a one time injection. We remain on track to file three BLAs over next three years by 2028 and first of those RQ400 for RP will begin rolling submission in the third quarter of this year. This positions the first half of 2027 as a catalyst rich window for Ocugen Inc with phase three top line data for AQ400 top line phase two three data for AQ410ST and BLA submissions, all expected to converge over a short period. In the first months of 2026 we completed enrollment in two of our late stage programs, delivered positive phase to top line data in the third and are diligently working toward initiating our first BLA submission later this year. Let me walk you through how each program is advancing starting with RQ400 for RPE. The Phase 3 Limelight Clinical Trial is the only broad gene agnostic RP trial and the largest known phase three orphan gene therapy trial in the field. Approximately 300,000 people in the US and Europe are living with RP, which is caused by mutations in more than 100 genes. The only approved gene therapy for RPE today targets a single gene RPE65 which accounts for just 1 to 2% of all RPE cases. RQ400 is designed to provide a therapeutic option for the remaining 98 to 99% of RPE patients and that is a fundamentally different commercial opportunity. Enrollment in Limelight is Now complete with 140 patients randomized 2 to 1 across the row and gene agnostic arms covering over 25 genetic mutations associated with early to advanced stage RP, including pediatrics. The breadth of population intended to validate the gene agnostic mechanism of action of our novel modifier gene therapy platform. The primary endpoint is 12 month change in visual function and assessed by luminance dependent navigation assessment or LDNA (Luminance Dependent Navigation Assessment). We plan to initiate the rolling BLA submission for RQ400 in the third quarter of 2026 and complete BLA submission by the second quarter of 2027. Phase three top line data is expected in the first quarter of 2027 with the potential FDA approval targeted for the fourth quarter of 2027. On the manufacturing side, process performance qualifications, PPQ batches completion is on track for the second quarter of 2026 and brand planning and marketing initiatives led by Abhigupta, our EVP of commercial and business development continue to scale in preparation for launch. RQ400 continues to demonstrate encouraging long term durability with the three year data supporting sustained improvement in visual function compared with untreated eyes. In the Phase 1/2 study the treatment effect was maintained over time across evaluable subjects with the clinically meaningful mean changes in LLVA observed at years 1, 2 and 3 in both the multiple mutation and ROW subgroups. Importantly, these results suggest the benefit is not limited to a single genetic subtype reinforcing the program’s gene agnostic mechanism for action. From a safety perspective, RQ400 continues to show a favorable profile with no serious adverse events reported as being related to treatment. At the three year time point, 88% of treated valuable subjects demonstrated either improvement or preservation in visual function relative to untreated eyes, highlighting both durability and consistency of the response. Taken together, these data support the potential for OCU 400 to deliver sustained clinical benefit over time in retina’s pigmentosa while maintaining a strong safety profile. Turning to OCU410SD for Stargardt disease Stargardt Disease is a pediatric onset retinal disorder affecting approximately 100,000 patients in the US and Europe and roughly 1 million globally. There are no approved therapies available for these patients today. OCU410ST is designed to address over 1200 pathogenic mutations in the ABCA4 gene with a single one time treatment. On April 1, we announced the completion of enrollment and dosing in our Phase 23 Guardian 3 pivotal confirmatory trial, enrolling 63 participants in in less than nine months, well ahead of the originally planned timeline. That pace reflects both the depth of unmet need in Stargardt disease and the exceptional engagement of our investigators and patient community. The interim analysis is planned for the third quarter of 2026 with the top line phase III data expected in the second quarter of 2027 and BLA submission to follow by mid 2027. OCU 410ST continues to demonstrate a favorable safety and tolerability profile with the no product related serious adverse events reported to date. Turning now to OCU410 for GA late stage dry age related macular degeneration. GA represents our largest commercial opportunity with approximately 2 to 3 million patients in the United States and Europe combined. There are currently no approved treatments for GA in Europe. The United States Approved therapies require 6 to 12 intrauterial injections per year, indefinitely carry meaningful safety risks, including conversion to Vit AMD in roughly 12% of treated patients and face real world dropout rates of nearly 40%. GA is a multifactorial disease driven by four distinct pathways that contribute to the progressive degeneration of the macula, lipid deposits, drusen, chronic inflammation, oxidative stress and complement activation. The currently approved therapies in the US address only one of these four pathways, the complement system, which is partly why they have been unable to demonstrate meaningful functional outcomes for patients. OCU410 operates differently by delivering rora, a nuclear hormone receptor that acts as a master regulator of retinal homeostasis. OCU410 is designed to address all four disease pathways simultaneously with a single subretinal injection has the potential to redefine the standard of care in this indication. In March, we reported positive top line 12 month data from our phase 2 ARMADA clinical trial. The study enrolled 51 patients aged 50 years and older with GA lesions in the foveal or non foveal region. Randomized 1 to 1 to receive a single subretinal administration of OCU 410 at a medium dose, high dose or no treatment in the control group. The optimal dose, which is the medium dose, demonstrated a 31% reduction in lesion growth relative to control at 12 months with a P value of less than 0.05. To put this in context, currently approved intrautereal therapies have shown approximately 15% reduction at 12 months for avanthicopigal and 22% reduction at 24 months for Pancytico Plan OCU 410 administered as a single on time …
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