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 Enchausti, Head of Investor Relations and Communications for Ocugen, who may begin.

Thank you, Operator. I'd like to welcome you to our conference call. With me today are Occogen'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 a financial update. Earlier this morning, we issued a press release including a business update and first quarter financial results for 2022. 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 slides will be available on the investor section of the Ocugen website for approximately 45 days. As always, we need to advise you that this call will contain 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 biologics license application for Kavaxin to the FDA, and whether and when we will receive regulatory approvals for Kavaxin in the U.S., Canada, or Mexico. 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. Finally, our 10-Q will be filed soon after today's call. I will now turn the call over to OccuGEM's chairman, CEO, and co-founder, Dr. Shankar Musunuri.

Thank you, Ken. Good morning, everyone, and thank you for joining. We hope you and your families are safe and well. We're here today to review for you the most recent activities and events that took place over the first quarter of 2022, along with providing a financial update. OccuGEM's value proposition of courageous innovation comes from the diversity within our pipeline. It brings multitude of opportunities to develop new medicines in D.C. states where options are either limited or non-existent. In the long run, oxygen success is connected to our ability to bring innovative and meaningful medicines that generate significant value for patients and society. We are being forward-looking in our approaches with Covaxin. using this particular time to enhance our clinical development program. At the World Vaccine Congress in late April, speakers all agreed that public health strategies need to expand and more vaccine options are needed. And as typical with the pandemic, the science has changed the landscape again. All of this still demands that our nation needs vaccines that go beyond the spike protein and attack the other targets such as the end protein with the long-term durability. Durability and a broader immune response may be important for realizing a bolster strategy for annual vaccinations. People want options for vaccinating themselves or their children, including vaccines built on a traditional platform. We clearly have a role to play, and we are pressing forward to fulfill our commitment. And our founding focus, blindness diseases, is becoming clearer, especially with our vital network in retinitis pigmentosa, a disease for which there are no medicines to block disease progression, no cures, and limited treatments to help manage someone's tragic journey that leads to blindness. The oxygen team continues to charge ahead, and over the course of this past quarter, We are seeing great progress mixed in with the challenges that are characteristic of the life sciences business. I'm especially confident that the team is well situated to advance our efforts. This slide contains important opportunities we see ahead of COVAXIN. But before I get to those opportunities, I'm going to address how we are working through some obvious headwinds. Health Organization announced it wanted our partner Bharat Biotech to address deficiencies found in the manufacturing facility used for Covaxin, which led us to temporarily pause the dosing of subjects in our Phase 2-3 study, OCU-002. The FDA subsequently placed the study on clinical hold. Under the backdrop, there are some important facts to share. First, the WHO affirmed that the available data indicate Covaxin is effective and no safety concerns exist. Second, we have provided information to the FDA and are working towards resolving this issue so that we can resume the clinical trial. Even so, we have not stopped finding opportunities to commercialize Covaxin, and we recently added Mexico as a part of what is known as the oxygen territory. This was made possible because of the strong relationship we have with Mark Biotech, who shares our objectives with the Mexican government to fight COVID-19. With this contract amendment, we expanded our commercial footprint to now cover all of North America. Covaxin already has emergency use authorization in Mexico for adults, and application for pediatric use, two to 18 age group, is under review. We are currently working on commercializing the vaccine in Mexico. Now let's turn to our modifier gene therapy program. Central to OxyGEN's research and development are inherited retinal diseases for which there are no options and only one gene therapy modality exists. Our modifier gene therapy, unlike traditional gene therapy, has shown in preclinical models to affect the regulators of genes called nuclear hormone receptors, or NHRs. Activating these NHRs modulates gene activity and maintains homeostasis. When gene networks are not functioning properly, this unbalanced state can lead to disease. For oxygen, that's a family of inherited retinal diseases that cause blindness. Modifier gene therapies, when influencing NHRs, can resolve disease progression, affect disease onset, or how disease present in the body. like blindness diseases associated with NR2E3, rhodopsin, or mutations, other mutations. Our Phase 1-2 safety and efficacy clinical trial for OQ400 targeting retinitis pigmentosa associated with gene mutations NR2E3 and rhodopsin is ongoing. I'm very pleased to say that we dosed our second patient this week. This is a significant accomplishment in an innovative therapeutic category because, for the first time, we're evaluating this modifier gene therapy concept with the rhodopsin mutation in the ophthalmology disease space. By the end of the study, we will collect data from 18 patients, which will constitute three cohorts of three different doses before moving onto a phase three clinical trial. If successful, this therapy has potential to treat many mutations under RP. Currently, RP has about 150 mutations. About two million people globally struggle with these blindness diseases. Additionally, no therapies exist today to rescue them from disease progression, so our sense of urgency for rescuing one site is critical. Our next candidate, RQ410, has IND-enabling studies underway to support a future Phase I-II clinical trial. targeting dry age-related macular degeneration. Finally, our novel biologic, OQ200, a transferrin TumStat infusion protein that has the potential to help those with diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration, is progressing well with IND-enabling activities to support a future Phase I-II clinical trial. We hope to move both RQ410 and RQ200 to clinic next year. In summary, despite the headwinds, we have a plan to move quickly on our Covaxin clinical trials that are required for a BLA submission. We will continue to provide updates on these clinical trials. What's important to remember is that the strength of our pipeline is found in the diverse innovation we're exploring especially in our modifier gene therapy platform and our novel biologic. Today, we are looking for new therapies, such as RQ400, 410, and 200, against a multitude of blindness diseases. But we also have our sights set on other disease states that could benefit from this modality. Overall, we have made significant progress this quarter, and we remain confident in the long-term opportunities and growth that we believe our pipeline will unlock for our patients and shareholders. I'm very proud of our team that is so dedicated with the focus on patients. I will now turn the call over to Jess to provide our first quarter 2022 financial update. Jess?