Good morning and welcome to Ocugen’s second quarter 2023 financial results and business update. Please note that this call is being recorded at this time. All participants’ lines are in 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. Joining me today are Ocugen’s Chairman, CEO and Co-Founder. Dr. Shankar Musunuri, who will provide a business and financial update, and Dr. Arun Upadhyay, our Financial and Scientific Officer, Head of Research, Development and Medical, who is also on the call to answer questions during the Q&A. Yesterday afternoon, we issued a press release detailing business and operational highlights for the second 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 of 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 risk factors and uncertainties and 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 - the SEC, including the risk factors described in the section entitled, Risk Factors, and the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this 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 second quarter of 2023 has been filed. I will now turn the call to Dr. Musunuri.

Thank you Tiffany. Good morning and thank you all for joining us today. The second quarter of 2023 marked a period of continued progress toward our regulatory and clinical milestones, which we are dedicated to advancing through end of the year. With a strategic focus on our novel modified gene therapy and biologic-based ophthalmic programs, we expect to begin dosing patients across these platforms by the end of this year. We are on track to initiate OCU400 Phase III adult trials near the end of 2023, early 2024, subject to outcomes of ongoing Phase I/II trials and discussions with FDA on proposed Phase III trial plans. We also anticipate a clinical study results update for OCU400 this quarter. Investigational new drug applications were cleared by FDA for OCU410 and OCU410ST for geographic atrophy and Stargardt disease, respectively. We plan to initiate Phase I/II trials by the end of 2023. We are also planning to initiate the Phase III clinical trial for regenerative cell therapy product candidate, Neocart, in the second half of 2024. This would mean Ocugen would have late-stage programs in gene and cell therapies in 2024. In an effort to conserve our working capital and advance our patient-centric agenda to develop a novel inhaled mucosal vaccine platform, we have submitted multiple proposals to obtain non-dilutive government funding and are having discussions with pertinent agencies to secure their support for our OCU500 vaccine series. Our first-in-class modifier gene therapy to treat multiple inherited retinal diseases remains unmatched industry wide. This unique gene-agnostic approach has the potential to address retinal diseases caused by mutations in multiple genes with one product. Our goal is to build on the innovation of gene therapy and expand its potential to treat a wider population of patients suffering from a host of rare retinal diseases…

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

The floor is now open for your questions. [Operator instructions] Our first question comes from the line of Jennifer Kim from Cantor Fitzgerald. Please go ahead.

Hi, good morning. Thank you for taking my questions. I have two. The first is as you’re thinking about cash burn going forward and you’re seeking non-dilutive funding opportunities, excluding the one-time impairment expense, is this quarter a good basis as we think about quarterly burn? Then my second question is on the OCU400 program. Can you remind us what you’re looking for in that updated data this quarter as sort of the go/no-go for the Phase III adult trial? Thanks.

Yes Jennifer, good morning. Let me address the first question, then Arun is going to take the second one. Yes, there is a one-time impairment charge. There is also a non-cash stock comp charge of $2.6 million, and if you add those two, the cash comes out to be $15.9 million total per quarter, so that would be good guidance for you for the future. I’ll let Arun address the other question on the OCU400 program.

Thank you Shankar, thanks Jennifer. Yes, you are right - I think our this quarter update on OCU400 clinical Phase I/II data will guide us about our Phase III study. Yes, that’s the data that will be used as a basis for go/no-go decision for Phase III.

Okay, and can you remind us what you’re looking for in that data?

Primarily we are looking at the functional improvement in the patients treated with OCU400, and the focus is going to be the RP patient.

Okay, and then in your discussions with the FDA later on for the Phase III trial, is that going to focus on RP patients or are you also considering the inclusion of LCA patients? Thank you.

To begin with, we will start with the RP patients, and as we collect the data for LCA patients, then later we will include LCA. But to begin with, yes, we are planning to go with [indiscernible] RP patients.

All right, thanks for taking my questions.

Our next question comes from the line of William Ramakanth from HC Wainwright. Please go ahead.

Thank you, this is RK from HC Wainwright. A couple of quick questions on the 400 program, and then maybe one on the Neocart. On the 400, in terms of your discussions with the FDA, is that being planned once you see the data on the Phase I/II, or you have already initiated some initial conversations and started putting together a Phase III plan?

Thanks RK. We have not initiated our discussions with FDA yet, so once we complete the data analysis, only then we are going to reach out to FDA, but that is planned for this quarter related to the [indiscernible] and followed by reaching out to FDA.

Thank you for that. Then on the 410 program, in terms of now that you have already been cleared by the FDA, what else needs to get done before you can initiate the Phase I/II study?

We need to get the site ready and initiate the patient screening, so that’s why I think we are planning to launch first subject in this study, both GA as well as Stargardt, this year. It’s more like getting ready with the clinical site.

Got it. Then on the Neocart program, I’m just trying to understand, if the facility does get completed the end of ’23, what else needs to get done in terms of commissioning the plant, getting the clinical material ready, to add to your program on the Phase III study by second half? Is it just that, or is it, you know, you still have to design the protocol? I’m just trying to understand what all, because we have been talking about this program for almost a year and a half now.

Yes, so RK, the facility construction will be completed at the GMP facility by end of this year - it’s on target, and then as you know, as a GMP facility it takes a few months for getting the qualification done, and then they’ll be ready to produce Neocart in the facility. In the interim, obviously the team is going to prepare CMC and clinical sections and will continue to update those, so that they’re ready for submission next year before they start the clinical trial. We do have automatic designation, right - I just wanted to remind, [indiscernible] advanced therapy designation with FDA, so if we have any questions in the interim, we can always reach out to them and get clarification.

Perfect. Thanks for taking my questions.

Our next question comes from the line of Robert LeBoyer from Noble Capital Markets. Please go ahead.

Good morning everyone. My question has to do with the upcoming data presentation, and I was wondering if you could disclose whether the data to be presented will update the previous data on all patients or whether it will just be in new patients that haven’t been reported, and wondering if there are any end points that you could share with us at this point.

Thank you, so yes, definitely we will be providing detailed updates when we kind of know, present this data to the market. But to address your first part of the question, whether it is going to include the percent we presented in our previous disclosure, yes, we will include those subjects as well as some new subjects which have completed additional follow-up visits. It will be a combination of both.

Great. You had mentioned corporate partnerships for the gene therapy. Can you discuss any type of arrangements, whether they’re going to be research and development or just marketing, or any objectives to the business development activities?

Robert, this is a [indiscernible] question. Obviously we will be open to--when you seek partnerships at this stage as a biotech, big pharma established with an infrastructure and everything else, obviously your first target is going to be commercial. As you know, complex science is involved in these clinical trials. Obviously when you’re going into Phase III, once we have the data out, we’ll obviously work very hard with any potential partners, and obviously as you know, if they are interested in commercial development, they will be interested in Phase III programs too, so I think we will keep our options open, whatever can maximize our value for Ocugen as well as make sure we have ability to provide market access to patients who desperately need this product.

Okay, great. Thank you very much.

Our final question comes from the line of Daniil Gataulin from Chardan. Please go ahead.

Hey, good morning guys. Thank you for taking the questions. I’ve got a couple, one for OCU410 programs. Just wanted to ask strategically, how do you see it positioned long term, whether it’s viewed as a standalone approach or in combination with anything else, and the patient population that you will be targeting. The second question is for the inhaled vaccine series. Can you comment on your interactions to date regarding the funding, and particularly if you can comment on the interest in this program given that there are several other [indiscernible]? Thank you.

Thank you. I’ll take the first question. Yes, we are thinking of taking [indiscernible] standalone product, and to begin with, definitely we will be targeting the advanced form of AMD, that is geographic atrophy, but subsequently based on the outcome, it may further develop for early and intermediate stage depending on the clinical benefit coming from the GA trial. Regarding how we see this product against other, what we see in the market, as you all know that AMD is a multi-factor disease and so far we have been seeing in the space that most of the companies are focused on targeting only one pathway, and by the very nature of this disease, being multi-factor [indiscernible], there are various causes which lead to this disease. Our product has potential to target all those pathways which are linked to dry AMD pathogenesis, so we believe that this could be a differentiated product and have potential to offer better clinical benefit compared to what we have right now.

Good morning. The second question related to government funding, again we have been working with various agencies and will provide an update. Obviously the current products, as you know, the vaccines we have especially for COVID, they lack a couple of things. One, they are struggling to control the transmission, there’s a lot of data available right now, and also they lack durability, so what would be an ideal option going into the future, I think there is definitely a need for mucosal vaccines - the scientific community agrees on that, and also that will provide systemic as well as mucosal immunity, so it can actually potentially prevent at the target of viral entry into mucosal systems. The second thing is durability. We believe and the scientific community believes that COVID vaccinations, in order to gain the compliance with the public, you cannot keep on vaccinating every three months. That’s why people get vaccine fatigue, so you need to move into annual vaccinations such as flu, so your compliance here could go up, so that’s the intent. I think as we stated, there are ex-U.S. trials with inhalation vaccines using a similar technology that showed durability up to one year - that’s really important. There are two things - controlling transmission and durability are very important for next gen vaccines, and we believe our platform technology, inhalation vaccines for COVID and flu, they can provide that.

Got it, thank you so much.

This concludes the Q&A portion. I will now turn the call back over to Chairman and CEO, Dr. Shankar Musunuri.

Thank you Operator. In closing, I would like to recognize the entire team for their resilient efforts to advance our patient-centric mission. To our shareholders and partners, thank you for your ongoing trust and support. We are already well into the second half of 2023 and are steadfast in our commitment to transparency and decision-making based on sound scientific principles, and a tireless work ethic dedicated to excellence in all phases of research, development and clinical testing. We remain confident that we’ll be able to fulfill our mission of developing novel therapies with innovative discoveries to bring to market effective treatments for patients suffering from a range of conditions that currently lack treatment options. We look forward to sharing more details on our progress in the coming months.

Thanks everyone, have a great day.