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

NIAID will execute the clinical trial for OCU500. Upon completion of the trial, Ocugen will possess full rights of reference to the findings. This initiative is a testament to the fact that COVID-19 is still rampant with emergence of new variants and needs more durable vaccines to treat them. In a recent Harris Poll, we favorably found that 66% of Americans would prefer to have more vaccine options. The poll also found that 52% of Americans would be more open to getting an intranasal or inhaled versus injectable COVID-19 vaccine. In line with NIAID’s missions to support innovation and public health, we look forward to potentially expanding the platform to the flu and other respiratory viral diseases and infections. I would like to bring our pipeline updates to a close by providing a brief update on NeoCart.

Ocugen’s autologous regenerative cell therapy, which uses patients’ own cartilage cells, is on track to begin its Phase 3 clinical trial in the second-half of 2024. A cGMP facility for manufacturing NeoCart is expected to be completed at the end of 2023, and qualification is expected in the first-half of 2024. OCU200 is an ophthalmic biological product candidate in preclinical development for treating severely sight-threatening diseases like diabetic macular edema, diabetic retinopathy, and wet, isolated macular degeneration. We are working on responses and continue to interact with the FDA regarding the clinical hold on our OCU200 IND submission and expect to initiate a Phase 1 clinical study in the first-half of 2024. With that, I will now turn the call over to our Corporate Controller, Michael Breininger, to provide an update on our financial results for the third quarter ended September 30, 2023.

Michael?

Michael Breininger: Thank you, Shankar. Our research and development expense for the quarter ended September 30 2023, were $6.3 million, compared to $15.6 million for the third quarter of 2022. General and administrative expenses for the quarter ended September 30 2023, were $9.1 million, compared to $7.5 million during the same period in 2022. Net loss was approximately $14.2 million or $0.06 net loss per share for the quarter ended September 30, 2023, compared to a net loss of approximately $21.9 million or $0.10 net loss per share for the third quarter of 2022. Net loss was approximately $53.6 million, or $0.22 net loss per share, for the nine months ended September 30, 2023, compared to a net loss of approximately $59.4 million or $0.28 net loss per share for the nine months ended September 30, 2022.

Our cash, cash equivalents and investments followed $53.5 million as of September 30, 2023 compared to $90.9 million as of December 31, 2022. As always, we are constantly exploring strategic and shareholder-friendly opportunities to increase our working capital, and we’ll be focused on seeking out corporate partnerships for gene therapies and non-dilutive funding for vaccines. That concludes my update for the quarter. Tiffany, back to you.

Tiffany Hamilton: Thank you, Mike. We will now open the call for questions. Operator?

Operator: [Operator Instructions] We have a question come from the line of [Indiscernible] H.C. Wainwright. Your line is open.

Swayampakula Ramakanth: Hey, good morning, Shankar and team. Here is RK Arthur for RK. Congrats on the progress. So I just had a couple questions 400. So when could we expect the complete data set from a Phase 2 study, especially for the LCA patients. So if you can give some color on that would be really appreciated?

Shankar Musunuri: Yes, the LCA, We just dosed, so I think it’ll take until later part of next year.

Swayampakula Ramakanth: How about the other patient left in the RP group?

Shankar Musunuri: Yes, the RP patients will get it in the first-half. However, we believe we have adequate information and we’re working with regulatory agencies, FDA and DMA for Phase 3.

Swayampakula Ramakanth: Okay, so speak of the Phase 3 study. So from what you said in the press release and the core, is the Phase 3 will be a single Phase 3 packed together, both RP patients as well, LCA, or it could be two separate Phase 3 study?

Shankar Musunuri: We’ll start with RP because that’s the data we have right now and then we’re going to add LCA arm little later in the clinical trial.

Swayampakula Ramakanth: Okay, so that would be in the single Phase 3 or?

Shankar Musunuri: Yes, single Phase 3.