Ocugen, Inc.

Good morning and welcome to the OcuGen conference call. At this time, all participants are in 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 would now like to turn the conference over to Lisa DeCenza, Vice President of Integrated Communications at Lavoie Health Science, to introduce the Ocugen team. You may begin.

Thank you, Operator. I'd like to welcome you to our conference call. With me today are Ocugen's Chairman and CEO, Dr. Shankar Musaneri, and our CFO and Head of Corporate Development, Sanjay Subramanian. Earlier this morning, Ocugen issued a press release including a business update and first quarter 2021 financial results. We encourage listeners to review the press release, which is available on the Ocugen website at www.ocugen.com. This call is also being recorded and a replay will be available on the investor section of the Ocugen website for approximately 45 days. Before we begin our formal comments, I'll remind you that various remarks we make today constitute 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, estimates, anticipates, expects, 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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts. regulatory submissions, and regulatory authorizations or approvals. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and or launch dates, as well as risks associated with preliminary and interim data including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data. The risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review slash publication process, in the scientific community generally, and by regulatory authorities, whether and when data from Barat Biotech's clinical trials will be published in scientific journal publications, and if so, when and with what modifications, whether the U.S. Food and Drug Administration, the FDA, will be satisfied with the design of and results from preclinical and clinical studies of Covaxin, which have been conducted by Bharat Biotech in India, whether and when any biologics license and or emergency use authorization applications may be filed in the United States for Covaxin, whether and when any such applications may be approved by the FDA, decisions by the FDA impacting labeling, manufacturing processes, safety, and or other matters that could affect the availability or commercial potential of Covaxin in the United States, including development of products or therapies by other companies. 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, 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 intend to file our Form 10-Q with the SEC today. Any information we provide on this conference call is provided only as of the date of this call, May 7, 2021, And except as required by law, we undertake no obligation to update any forward-looking statements we make on this call on account of new information, future events, or otherwise. I will now turn the call over to Ocugen's Chairman and CEO, Dr. Shankar Musuneri.

Thank you, Lisa. Good morning, everyone, and thank you for joining us. There is not a day that goes by without us witnessing the devastation caused by the coronavirus pandemic. As you all know, India is currently experiencing one of the worst spikes seen by any country since the pandemic began. Over the last two weeks, COVID-19 has claimed about 120 lives every hour on an average in India with the second wave of devastating COVID-19 infections. Our hearts go out to the people of India and those working on front lines to bring this terrible outbreak under control. We also sincerely appreciate the work done by caregivers, NGOs, governments, including the U.S. government, and everyone who is helping. Our co-development partner for Covaxin, Bharat Biotech, has been ramping up production to meet the demand for the vaccines in India. They are navigating these extreme conditions to scale up production and increase supply It is encouraging to note as Dr. Anthony Fauci, Director of NIAID and the Chief Medical Advisor to the President mentioned last week, studies of convalescent sera of Covaxin recipients have found that Covaxin effectively neutralizes the B1617 variant or Indian double mutant strain of the coronavirus. However, it is concerning that according to the World Health Organization, The variant has been detected in 17 countries, including the US. We continue to strongly believe that it is critical to add Covaxin to our national arsenal to fight this pandemic. We are encouraged by our announcement earlier this week that Covaxin demonstrated potential effectiveness against three key variants of SARS-CoV-2, the UK variant, which is B117, the Indian double variant, B1617, and Brazilian P2 variant, B11282. By addressing the whole COVID-19 virus based on multi-antigens, including the spike and nucleocapsid proteins, Covaxin's potential effectiveness against multiple variants reduces the possibility of mutant virus escape. This is an important differentiator from currently available vaccines in the U.S., which only address the spike protein. Covaxin elicits a broad-spectrum immune response of 98.3% seroconversion. By stimulating both humoral and cellular responses against multiple viral proteins, Covaxin could be a more powerful weapon that is more likely to remain effective as the virus continues to mutate, making it a strong booster vaccine option, even for those who have already taken one of those other vaccines. In the recently shared second interim results of the Phase III clinical trial, Covaxin demonstrated 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations. Covaxin continues to show strong results in all the studies conducted to date. The oxygen team submitted a comprehensive drug master file with the FDA and is preparing the EUA applications. The current crisis in India is hampering some of the data collection efforts by our co-development partner Bharat Biotech. As a result, finalizing our EUA application is taking longer than anticipated. Despite the humanitarian crisis in India, Bharat Biotech and Ocigen are working tirelessly and diligently to complete the EUA application, and we hope to file it with the FDA as soon as practicable. Meanwhile, we are having collaborative discussions with the FDA. We have also signed up with an FDA-approved lab for release testing of the vaccine upon authorization, and we are actively working on securing contract manufacturing partners in the U.S. We are also in discussions with the Biomedical Advanced Research and Development Authority, BARDA, regarding a purchase commitment. Once authorized under EUA, we are planning for a pediatric study in kids six months and older because we believe Covaxin has a very strong safety profile as it is based on a traditional vaccine technology platform. We believe that Covaxin can help change the course of this pandemic by preventing severe COVID-19 disease, including hospitalizations, as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. to shift to an update on our ophthalmology pipeline. Yesterday, preclinical results of our novel biologic candidate, OQ200, were presented at the Association for Research in Vision and Ophthalmology 2021 Annual Meeting. The purpose of this study was to evaluate efficacy of OQ200 in in vitro and in vivo models for ocular neovascular diseases. OQ200 reduced neovascularization and damage to retina and demonstrated comparable or slightly improved activity to efflubaricept in an animal disease model. RQ200, a transferrin-thumbstatin fusion protein, demonstrated potential to treat diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration. We are planning the initiation of Phase I-II clinical trial for OQ-200 next year. We remain on track to initiate our first gene therapy Phase I-II clinical trial for OQ-400 later this year. The toxicology studies are progressing well. We have completed manufacturing a 200 liter scale to support clinical studies. We're also planning to initiate a Phase I-II clinical trial for OQ-410 for dry age-related macular degeneration next year. Late last month, we announced closing of a registered direct offering with the healthcare-focused institutional investors and raised gross proceeds of $100 million. We intend to use the net proceeds from the offering for general corporate purposes, capital expenditures, and working capital expenses. The capital raises this year have significantly strengthened our balance sheet, and position us well to develop our programs and build our team. In summary, we're working diligently to bring Covaxin to the U.S. market with the planned filing of our EUA application and eventually a BLA biological licensing application. We're continuing to expand our team with highly talented individuals to support our growth. We're also planning to move our lead ophthalmology gene therapy product candidate, OQ400, into the clinic later this year. With the ability to raise additional capital as needed, we have the resources to continue driving our vaccine and ophthalmology pipelines forward and anticipate strong momentum across our pipeline for the remainder of this year. I will now turn the call over to Sanjay to provide our first quarter 2021 financial update.