Ocugen, Inc.

Good morning and welcome to the Ocugen conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Ken Chowstee, Head of Investor Relations and Communications for Ocugen. Sir, you may begin.

Thank you, operator. I'd like to welcome you to our conference call. With me today are Octogen's chairman, CEO, and co-founder, Dr. Shankar Musunuri, who will provide a business update, and our chief financial officer and head of corporate development, Sanjay Subramanian, who will provide a financial update. Earlier this morning, we issued a press release including a business update and fourth quarter and full year financial results for 2021. We encourage listeners to review the press release, which is available on our website at www.ocugen.com. This call is also being recorded, and a replay, along with accompanying slide presentation, will be available on the investor section of the Ocugen website for approximately 45 days. As always, I need to advise you that this call will contain certain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations, including, among other things, the uncertainties inherent in research and development of our product candidates, risks to our business related to the ongoing COVID-19 pandemic, uncertainty regarding whether and when we will be able to submit a biologic license application for Kavaxin to the FDA, and whether and when we will receive regulatory approvals for Kavaxin in the United States or Canada. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. You should read carefully the risks and uncertainties described in today's press release, as well as the risk factors included in our filings with the SEC. Note that we will intend to file our Form 10-K by March 1st. I will now turn the call over to OccuGEN's chairman and CEO, Dr. Shankar Musanuri.

Thank you, Ken. Good morning, everyone, and thank you for joining, and we hope you and your families are safe and well. We are here today to review with you some of the most recent activities and events that transpired in the fourth quarter of 2021 and provide some perspective on the full year. 2021 was a transformational time for OccuGEN. especially as we successfully progressed two different assets within our portfolio. Simultaneously, we expanded and diversified our team to match our growing clinical development, commercial, and R&D needs. This was a year in which Oxygen doubled down on what I called courageous innovation. That phrase speaks to our purpose and commitment to drug development with a purpose and grit, searching for new solutions to enduring challenges. from working to bring a new COVID vaccine into U.S. and Canada to initiating a clinical trial for a game-changing, innovative gene therapy that could potentially treat multiple genetic mutations with a single product. I'm proud of this team that has succeeded with our business partners to position us for so much more in 2022. This slide highlights some of the critical milestones for Covaxin in the later part of the year and into 2022. First, it's important to understand the context for the progress we made. We have seen that the science has evolved and our nation's strategies have changed. Today, the focus is on how to achieve ongoing protection and closing the gaps among populations who remain unvaccinated. In just one year, so much has changed. At OxyGEN, our work for Covaxin had to evolve over the months to meet this moment. that led to our IND submission in late October and our EUA submission in early November. That work has paid off. Last week, we received clearance from the FDA to initiate a clinical trial to support a biological licensing application, RBLA. Our clinical program will be a phase two slash three immunobridging and broadening study. We will provide more details over the coming months as the study progresses. On the pediatric EUF front, I'm pleased to say that there are discussions involving the data we have submitted, including Bharat Biotech's immunogenicity data published in a preprint server in late December 2021, our own Omicron research showing effectiveness against this variant, and a database of more than 36 million teens vaccinated with Covaxin in India, with more than 70% of Americans Looking for options. Based on our latest Harris Poll, we know the need is great. We will continue advocating the FDA gives the vaccine a fair shot by having it evaluated by its independent vaccine advisory committee, known as ORFACT. We recognize that many of you have been asking for ongoing regulatory updates and asking why the review can't move faster. We hear you, and we would note two things. The first is that I'm pleased with the timeframe it took to have the clinical hall lifted. That took less than three months. The second is that getting to the critical juncture required significant confidential dialogue with the FDA. Therefore, making public those details would have been detrimental to the review process. So once the review process starts, Very little can be disclosed until there is clear guidance from the agency. In Canada, we have supplied a comprehensive set of responses to Health Canada from follow-up questions contained in what is known as a notice of deficiency. Remember that Covaxin is now under the new drug submission review, which will potentially lead us to full approval. We are following up with Health Canada to determine next steps. And speaking of Canada, there is growing interest from local and provincial government officials about our interest in the manufacturing site owned by Liminal Biosciences outside of Belleville, Ontario. Positive discussions with leaders have centered on the value of reestablishing a manufacturing and R&D hub within the region and for supporting that nation's contribution to innovation and public health. One final note about Covaxin. We're pleased to share with you that we have made good progress toward establishing manufacturing capability at our partner, Jubilant Hollister, in Spokane, Washington. This has involved designing a robust manufacturing process, establishing a means to transport active ingredient and sterile adjuvant from India to the US, selecting primary packaging components, and establishing quality control strategies that will provide additional assurance that the final product meets rigorous FDA standards and can be safely administered to people. The technology transfer is going well, and we expect to complete qualification manufacturing runs at Jubilant by the middle of this year. Now let's turn to our modifier gene therapy program. As you know, We submitted in November of 2021 an investigational new drug application for a phase 1 slash 2 clinical trial for RQ400, our lead candidate in the modifier gene therapy platform for the treatment of retinitis pigmentosa resulting from genetic mutations in R2E3 and rhodopsin. Within 30 days, the FDA accepted our application, and our dose range in clinical trial is now recruiting Details of the study are available on the National Institutes of Health website, clinicaltrials.gov. Our next candidate, Ocu410, has IND-enabling studies underway to support a future Phase 1-2 clinical trial. And our novel biologic, Ocu200, a transferrin-thumbstatin fusion protein that has potential to help those with diabetic macular edema. diabetic retinopathy, and wet age-related macular degeneration is progressing well with IND enabling activities. We are on track to initiate toxicology studies in non-human primates. So 2022 is off to a fast start with clinical trials for two product candidates with the data readouts expected second half of this year. Ongoing discussions with the FDA surrounding our pediatric EUA submission for Covaxin and continued progress on the remaining assets in our portfolio. I would like to thank our partners whose efforts are key to our progress. I'm very pleased with the progress we have made and know that we provide updates throughout the year. I will now turn the call over to Sanjay to provide our fourth quarter and full year 2021 financial update. Sanjay?