Ocugen, Inc. (NASDAQ:OCGN) Q3 2023 Earnings Call Transcript

Ocugen, Inc. (NASDAQ:OCGN) Q3 2023 Earnings Call Transcript November 9, 2023

Ocugen, Inc. beats earnings expectations. Reported EPS is $-0.06, expectations were $-0.08.

Operator: Good morning and welcome to Ocugen’s Third Quarter 2023 Financial Results and Business Update. Please note that this call is being recorded at this time. All participants’ line are in a listen-only mode. Following the speakers’ commentary, there will be a question-and-answer session. I will now turn the call over to Tiffany Hamilton, Ocugen’s Head of Corporate Communications. You may begin.

Tiffany Hamilton: Thank you, operator and good morning, everyone. Joining me on today’s call and webcast is Dr. Shankar Musunuri, Ocugen’s Chairman and CEO and Co-Founder, who will provide a business update and an overview of our clinical and operational progress; Michael Breininger, our Corporate Controller is also on the call to provide a financial update for the quarter ended September 30 2023; Dr. Arun Upadhyay, Chief Scientific Officer, Head of Research, Development and Medical, will be available to answer questions following the presentation. This morning, we issued a press release detailing associated business and operational highlights for the third quarter of 2023. We encourage listeners to review the press release, which is available on our website at ocugen.com.

This call is being recorded and a replay with the accompanying slide presentation will be available on the Investors section of the Ocugen website for approximately 45 days. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may in some cases use terms such as predicts, believes, potential, proposed, continue, estimate, anticipate, expect, plans, intends, may, could, might, will, should, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include, but are not limited to statements regarding our clinical development activities and related anticipated timelines.

Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, SEC, including the risk factors described in the section titled, Risk Factors, and the quarterly and annual reports we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of the presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a result of new information, future events or otherwise after the date of this presentation.

Finally, Ocugen’s quarterly report on Form 10-Q covering the third quarter of 2023 has been filed. I will now turn the call to Dr. Musunuri.

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Q&A Session

Shankar Musunuri: Thank you, Tiffany, and thank you all for joining us today. As emphasized in the press release we put out this morning, we continue to make significant headway with the development of our pipeline assets, particularly with our first-in-class ophthalmic gene therapy programs, and I’m proud of the momentum we have achieved to-date. Following additional positive and encouraging clinical study results from our novel modifier gene therapy based Phase 1/2 OCU400 study in September 2023. We believe we have strong clinical evidence to initiate our Phase 3 clinical trial in retinitis pigmentosa, RP, patients in early 2024 based on FDA conference. Utilizing a dual-track strategy, we also intend to expand our OCU400 Phase 3 trial in the second-half of 2024 to include patients with Leber Congenital Amaurosis LCA, contingent upon favorable results from the Phase 1/2 study.

With enrollment begun for our OCU410 and OCU410ST programs, we are diligently working to those patients this quarter. We anticipate clinical updates from our OCU400, OCU410, and OCU410ST studies in the later part of 2024. Our clinical and regulatory teams continue to work on responses to the FDA regarding our IND submission for OCU200, the company’s ophthalmic biological product candidate, and we plan to initiate a Phase 1 clinical study in the first-half of 2024 contingent on the lift of the FDA hold and adequate availability of funding. For our regenerative cell therapy candidate for knee cartilage repair, NeoCart we are on track to complete construction of our state-of-the-art cGMP facility at the end of this year, and are planning to complete qualifications of the facility in the first-half of 2024.

We plan to initiate the Phase 3 clinical trial in the second-half of next year. Last month, we were delighted to be selected for inclusion in a Phase 1 clinical trial funded by National Institute of Allergy and Infectious Disease to investigate the administration of our COVID-19 mucosal vaccine candidate, OCU500. Safety and immunogenicity of OCU500 will be evaluated using inhaled and intranasal routes of delivery during the Phase 1 clinical trial in the first-half of 2024. All these catalysts considered, we can safely reiterate that 2024 will be transformative for Ocugen. Our mission to introduce critically needed therapies into the market is imminent, with the planned initiation of Phase 3 trials encompassing gene and cell therapies in the near-term.

Our R&D team’s dedication and hard work has yielded significant progress and compelling results for our first-in-class modifier gene therapy OCU400 program for RP and LCA patients. Throughout the Phase 1/2 trial, our primary objective has been to observe safety and tolerability of the subretinal administration of OCU400 in subjects, as well as immune response and systemic distribution. For a preliminary science of efficacy, we focused on a few visual function and functional vision indicators, namely Best-Corrected Visual Acuity, BCVA; Low-Luminance Visual Acuity, LLVA, and MultiLuminance Mobility Test, MLMT. More details on our trial design can be found on clinicaltrials.gov with the identifier code listed at the bottom of the slide. Let me provide a situational analysis around the unmet need and under deserved market for RP and LCA patients, an estimated 1.6 million people globally are affected by RP and LCA combined.

In the U.S. alone, we’re looking at about 125,000 patients total. RP and LCA are classified as inherited retinal diseases from a group of heterogeneous disorders that affect the retina. These diseases often lead to sight loss and ultimately blindness. That said, the earlier homeostasis can be stabilized in patients with either of these diseases, the better. Through relevant medical meetings and continued engagement with advocacy groups, we aim to create awareness for the prevalence of retinitis pigmentosa and Leber congenial amaurosis and potential emerging therapies like our novel platform. Our ultimate objective is to provide treatment to people suffering from vision impairment and blindness caused by RP and LCA for whom currently no therapeutic options exist.

I listed our three exploratory endpoints for visualizations, stabilization, and improvement observed in patients treated with OCU400 on slide four. BCVA, LLVA, and MLMT. And the 12 cumulative subjects that have undergone a minimum of six months follow-up post-OCU400 dosing, we observe the following metrics. This venn diagram demonstrates that eight out of 12 subjects showed either stabilization means no change from baseline, plus minus four Lebers change for BCVA and LLVA, and zero Lux level change for MLMT, or improvement in all three parameters of BCVA and LLVA, which means five or more Lebers, and MLMT greater than or equivalent to on Lux level, demonstrating initial efficacy of OCU400. Non-responders are listed outside the circles for each group.