Ocugen, Inc.

Good morning and welcome to Ocugen's fourth quarter and full year 2022 financial results and business update call. Please note that this call is being recorded at this time. All participant lines are in a listen only mode. Following the speaker's 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. Joining me today are OccuGen'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 detail on our financial results. Earlier this morning, we issued a press release detailing business and operational highlights for the fourth quarter and full year of 2022. We encourage listeners to review the press release, which is available on our website at OccuGen.com. This call is being recorded and a replay of the accompanying slide presentation will be available on the investor section of the OccuGEN 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 predict, believe, potential, propose, continue, estimate, anticipate, Expect, plans, intend, may, could, might, will, short 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 and may cause actual events or results to differ materially from our current expectations. Investors should familiarize themselves with the company's filing for complete details. 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, Occitans 10-K covering 2022 will be filed soon after today's call. I will now turn the call to Dr. Musunuri.

Thank you, Tiffany. Good morning, and thank you all for joining us today. I'm excited to share with you the significant progress Occitans made in 2022 and during the first months of 2023 to further advance our diversified pipeline while continuously focusing on patients and pursuing courageous innovation. Fueled by our team's passion, dedication, and visionary mindset, we witnessed progress across all our clinical programs. I will also provide more on our objectives for 2023 leading into 2024. Let me commence with an update on our gene therapy program. In December 2022, we announced that RQ400, our investigational drug candidate for the treatment of retinitis pigmentosa and Leber congenital amaurosis, was granted expanded orphan drug designations by the US FDA, which supports the therapeutic potential of RQ400 to treat multiple inherited retinal diseases single product aki 400 is symbolic of oxygen's gene modifier approach that is based on nuclear hormone receptors that regulate diverse physiological functions in the retina such as development metabolism cellular functions and thereby establishes homeostasis to potentially restore retinal health and function in the us rp and lca affect 110,000, and 15,000 people, respectively. And globally, these conditions affect approximately 1.6 million people. And yet, despite its prevalence, RP and LCA patients have limited treatment options. As current approved organ development gene therapies focus on individual genes, RQ400 addresses shortcomings of current gene therapy approaches. As a broad-spectrum gene agnostic approach, to genetically diverse inherited retinal diseases. We have completed enrollment of RP patients in the Phase 1-2 trial for protocol and continue to enroll patients with LCA. We also established a high dose to be the maximum tolerable dose. We plan to start the Phase 3 clinical trial near the end of 2023. OCU-200, our biologic product candidate, is a recombinant fusion protein consists of two human proteins, thumb statin and transferrin, and is designed to treat severely sight-threatening diseases like diabetes, macular edema, diabetic retinopathy, and wet AMD. Millions of patients worldwide are affected by these conditions. However, current therapies target only one pathway, either angiogenesis or inflammation, and up to 50% of patient populations experience limited or no response to current treatments. OQ200 works with a distinct mechanism of action compared to existing therapies and targets multiple causative pathways, such as angiogenesis, oxidation, and inflammation, and has the potential to offer better treatment to all patients. Yesterday, we submitted an investigational new drug application, IND, with the U.S. Food and Drug Administration to initiate a phase one clinical trial of OCU-200 for treating diabetic macular edema, DME. This regulatory milestone fulfills the company's commitment to file the IND for OCU-200 within the first quarter of 2023. We are proud to further advance OCU-200, one of Ocugen's founding ophthalmic programs. Another major highlight in 2022 that I'd like to note is the expansion of our pipeline into cell therapy with Neocard, a phase III-ready regenerative cell therapy technology that combines evolutionary advancement in bioengineering and cell processing to enhance the autologous cartilage repair process. We are developing Neocard specifically for the treatment of articular cartilage defects in the knee. Current therapies to treat cartilage damage in the knee are suboptimal with varying outcomes due to variable cellular responses. The current standard of care suffers from factors such as pain, reduced knee function, failure to address cartilage damage, donor tissue availability, and open surgery. In addition to receiving a regenerative medicine advanced therapy designation from the FDA, we received a concurrence from the FDA on the confirmatory Phase III clinical trial design. We have already begun renovating our facility to accommodate CGMP manufacturing for clinical trials, and we are planning to initiate phase three randomized control study in subjects with articular cartilage defects in the first half of 2024. Now, turning to our vaccines portfolio and continued efforts to significantly mitigate the spread of COVID-19. From a public health perspective, we actively monitor the medical need for a more durable vaccine, as more than a million cases of COVID-19 were diagnosed in the U.S. over the last 30 days. The International Health Regulations Emergency Committee of the World Health Organization recently held a meeting in January this year to discuss the state of the COVID-19 pandemic, which revealed that the global risk of COVID-19 and its ongoing transmission is high. This assessment was based on factors regarding circulating SARS-CoV-2 variants of concern, status of global vaccination, and hybrid immunity, and the unexpected and relatively early seasonal return of the flu, which further encumbers already constrained healthcare systems. The data back this up. More than 5 million cases were diagnosed, and nearly 40,000 people died worldwide in the last 28 days. Current COVID-19 vaccines are limited by lack of durability and inability to stop transmission. As part of our commitment to address current gaps and the fight against COVID-19, we are developing a novel mucosal vaccine platform that includes OQ500, a bivalent COVID-19 inhaled vaccine, OQ510, a seasonal quadrivalent flu inhaled vaccine, and OQ520, a combination quadrivalent seasonal flu, and bivalent COVID-19 inhaled vaccine. The 500 series is based on a novel CHAD platform designed to reduce transmission and protect against new variants. The OQ500 series is designed for annual boosters. For the 2022 to 2023 flu season, over 50% of the U.S. population above six months of age received a seasonal flu shot. representing a market size of more than 170 million doses. The Ocu500 series of vaccines in the development grants Ocugen a distinct product candidate profile status that could significantly impact major global health obstacles and maximize our opportunity to serve broader patient markets. Regarding our injectable COVID-19 vaccine already in development, Covaxin, We successfully completed enrollment for our Covaxin Phase 2-3 immunobridging and broadening clinical trial in December 2022 and reported top-line data in January 2023. This data showed that Covaxin was well-tolerated and demonstrated immunogenicity. We plan to present final data and analysis at mid-year. At the beginning of November 2022, we held Archigen's first R&D day. since the company's inception to showcase our dynamic pipeline and world-class team to investors, analysts, KOLs, and other key stakeholders of the company. During that meeting, we shared the long-term outlook for the company. On this call, I would like to spend some more time recapping our key priorities over the next 12 to 18 months. First, our gene therapy programs. We're anticipating OCCI 400 preliminary efficacy data mid-year, and plan to start the Phase III clinical trial near end of the year. For OCU410, we're on track to submit INDs to the FDA in the second quarter of 2023 to initiate Phase I-II trials for dry AMD and Sargot disease. With OCU410, we believe we have potential one-time curative therapy with a single injection. Dry AMD affects vision in 10 million people in the U.S. and over 266 million people worldwide. Also targeting severe eye diseases, we look forward to the initiation of our Accu200 Phase I clinical trial with the preliminary data anticipated in the fourth quarter of this year. We plan to complete the CGMP facility construction for the manufacturing of Neocard in the fourth quarter in support of initiating a Phase III clinical trial in the first half of 2024. For our inhaled vaccine series, we are planning to file an IND to initiate clinical trials in the fourth quarter of 2024. One overarching and imminent objective for Opigen is to identify synergies and partnership with organizations that can help drive the development of our comprehensive pipeline. With that, I'm thrilled about the recent appointment of a new chief business officer Quan Wu, who is a seasoned healthcare business executive with more than two decades of experience in business development, strategy, and finance. We look forward to benefiting from the prospects of Quan's leadership and together further evolve as a fully integrated, patient-centric biotech company. Our strategic initiative to identify partnership for our programs is also critical for our operational objectives to Conso Capital and Extend Runway as appropriate. With that, I will now turn the call over to our Chief Accounting Officer, Senior Vice President of Finance, Jessica Crispo, to review our Q4 and 2022 financial metrics. Yes.