Ocugen, Inc.

Good morning and welcome to the Ocugen third quarter 2022 business update and financial results call. At this time, all participants are in a listen only mode. A question and answer session will follow the presentation. If you should require operator assistance, please press star zero on your telephone keypad. Please note this call is being recorded. I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications.

Thank you, Angela. Joining me today are Ocugen's Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri, who will provide a business update, and our Chief Accounting Officer and Senior Vice President of Finance, Jessica Crespo, who will provide more updates on our financial results. Earlier this morning, we issued a press release detailing business activity for Q3 2022. We encourage listeners to review this press release, which is available on our website at oxygen.com. This call is being recorded and a replay along with the accompanying slide presentation will be available on the investor section of the Oxygen website for approximately 45 days. This presentation contains forward-looking statements within the meaning of the private security Litigation Reform Act of 1995, which are based on the beliefs and assumptions of the Oxygen Incorporated and on information currently available to management. All statements contained in this presentation, other than statements of historical fact, are forward-looking statements. We may in some cases use terms such as predict, believe, 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 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, FDC, including the risk factors described in the section entitled Risk Factors, in the quarterly and annual report that we file with the SEC. 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, Occupant's third quarter 10-Q will be filed soon after today's call. I will now turn the call to Dr. Musaner.

Thank you, Tiffany. Good morning, and thank you for joining our call. I'm very proud of the important accomplishments we achieved in the third quarter. With courageous innovation as the driving force behind everything we do, we're diligently progressing with our cell and gene therapies and pursuing broader development and expansion of our vaccine program, which now includes a unique mucosal vaccine for RQ500 for COVID-19. We're also very enthusiastic about the potential of our modified gene therapy platform that we shared in more detail at the American Academy of Ophthalmology conference in Chicago and our first R&D day last week. The Ocugen team continues to charge ahead to establish ourselves as a fully integrated, patient-centric biotech company. As we meet our clinical and regulatory milestones, I'm especially confident that the team is welcome poised to drive science in new directions and break new ground for patients who have no effective therapeutic options and people who want choice in the fight against COVID-19. Today, we are going to provide updates on our vaccines, gene, and cell therapy programs. I would like to start with OccuGen's vaccines program. COVID-19 remains persistent, and the world critically needs more effective and safe vaccine options. we are realizing some of the limitations of vaccines currently available in the United States in terms of their durability and capability to reduce transmission. Up until now, much of the attention has been on reducing hospitalization rates, but we need to think much more broadly and consider what effects new variants will pose and what is required to face the unique challenges that this next phase of COVID-19 will bring. As I alluded to earlier, in September, we announced our licensing agreement with Washington University to develop, manufacture, and commercialize its proprietary mucosal vaccine in the United States, Japan, and Europe. RQ500 has the potential to generate rapid local immunity in the nose, mouth, upper airways, and lungs where SARS-CoV-2 enters and infects the body. We believe that a mucosal vaccine can help reduce the transmission rate by generating neutralizing IgG, mucosal IgA, and T cell responses. This approach represents a potential universal booster, regardless of previous COVID-19 vaccination. We intend to work closely with the U.S. government agencies tasked with pandemic preparedness on the regulatory pathway and the initiation of clinical trials. Additionally, we are addressing the public's need for a more durable immune response to COVID-19 with continued development of our candidate vaccine, Covaxin. Enrollment was completed and dosing continues in the Phase 2-3 immunobridging and broadening clinical trial with top-line data expected in early 2023. We are encouraged that no safety concerns have been identified in the trial today. As part of the technology transfer, we successfully completed a demonstration batch at Jubilant Hollister. We will have the ability to move forward once World Health Organization concerns with our partner have been resolved. Now, moving on to our gene therapy program. OccuGEN is deeply committed to our core technology focused on inherited retinal diseases, along with other blindness diseases affecting larger patient populations. We are making progress in our vital work in retinitis pigmentosa, a disease for which there is no cure, no medicines to block disease progression, and limited treatments to help manage the patient's tragic journey that ultimately leads to blindness. The Independent Data and Safety Monitoring Board completed a review of safety data for subjects enrolled in cohort two for the RQ400 Phase 1-2 clinical trial for retinitis pigmentosa, and recommended proceeding to enroll subjects in cohort 3. We have dosed the first patient, and the company expects to complete cohort 3 enrollment by the end of the year. By the end of the phase 1-2 study, data will be collected and analyzed from dosed RP and LCA patients before initiating the phase 3 efficacy trial. Currently, RP is associated with mutations in more than 100 genes affecting approximately 2 million people globally. The current study will start enrolling patients with a Leber congenital hemorrhagic cyst, or LCA, up to 90 mutations. LCA is a rare eye disease associated with mutations in more than 25 genes. Ocuportin, also leveraging our modifier gene therapy platform, is being developed to utilize the nuclear hormone receptor gene, RORA, for the treatment of dry age-related macular degeneration, or dry AMD, which affects approximately 9 to 10 million Americans alone. In this quarter, we are announcing the addition of OQ410ST to potentially treat Sargot disease, an orphan disease that will be investigated along with dry AMD. We have successfully completed CGMP manufacturing in support of clinical trials, and are currently conducting IND enabling studies. OQGEN is planning to file IND applications to initiate Phase I-II clinical trials for both these programs in Q2 2023. Another product modality in the retinal disease space is based on a novel fusion protein. OQ200 is designed to treat type threatening diseases such as diabetic macular edema, diabetic retinopathy, and wet AMD. Oxygen is currently executing IND enabling studies and is planning to submit an IND application in the first quarter of 2023 to initiate a phase one trial targeting DME. Regarding our regenerative cell therapies, in May, we expanded our pipeline into cell therapy and orthopedics with Neocot. Neocot shows potential to accelerate healing and reduce pain, rebuilding damaged knee cartilage and limiting the progression of osteoarthritis. Ocigen is working with the FDA to complete the Phase III protocol to advance its development and is building its own manufacturing suite to prepare for the study. Earlier this year, the FDA granted a regenerative medicine, advanced therapy, or RMAT designation to Neocort for the repair of full thickness lesions of the knee cartilage in adults. Our ambitious clinical agenda and the rigor in clinical development to advance our pipeline is reflective of our culture of courageous innovation. We're relentless in our pursuit towards our long-term goals and reaching the patients who can potentially benefit from our diverse pipeline. I will now turn the call to Jess to provide our third quarter 2022 financial results.