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.

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.

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…

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.

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

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

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?

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

How about the other patient left in the RP group?

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.

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?

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.

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

Yes, single Phase 3.

Okay, okay, I see. And the last question on 400 is, one is for regarding -- have you requested a meeting with FDA and based on your own proposal, which endpoint could be your primary endpoint? If you can…

I'll let Dr. Upadhyay answer that our CSO. Go ahead, Arun.

Thanks, Shankar. So we are considering a combinatorial approach and we have proposed that to the FDA and we are going to have a meeting with them this quarter and accordingly once we have alignment with FDA then we will update the market, yes.

All right. Sounds great. Thanks for taking my question.

Thank you.

Our Next question comes from the line of Robert LeBoyer with Nobel Capital Markets. Your line is open.

Good morning and thanks for taking my question. I just had a follow-up on the Phase 3 for OCU400 and wondering if you have any information or could disclose how many patients you expect to be in the trial or what the length of follow-up is going to be for the patients?

Good morning, Robert. I'll let Arun address that.

Yes, so we are planning in the range of close to 100 subjects in Phase 3 in 1:1 randomization and one year follow-up.

Okay, thank you very much.

Just to confirm it is 100, okay.

It's 100 patients, Robert.

Yes.

[Operator Instructions] There are no further questions at this time. I will now turn the call over to Chairman and CEO, Dr. Shankar Musunuri.

In closing, I'd like to reiterate our unwavering commitment to groundbreaking science and clinical innovations in order to create effective and positively impactful therapies that are accessible to patients globally. As we continue to execute stated plans, we remain focused on delivering long-term value for our shareholders, who have supported us and for prospects of Quant's seeking to be part of our story. Thank you and have a great day.

Thanks everyone.

This concludes today’s conference call. You may now disconnect.