Ocugen, Inc.

Good morning, and welcome to the Ocugen Second 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 that this call is being recorded. I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications.

Thank you, Samantha. 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 on our financial results. Earlier this morning, we issued a press release detailing business activity for Q2 2022. We encourage listeners to review the press release, which is available on our website at ocugen.com. This call is being recorded, and a replay, along with 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 Security Litigation Reform Act of 1995, which are subject to risks and uncertainty. We may, in some cases, use terms such as predict, believe, 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, but are not limited to, statements about the potential for neocart, autologous congenite-derived neocartilage, if approved, to provide an innovative new option for the repair of full-thickness lesions of the knee cartilage in adults, as well as Ocugen's intention to begin dosing in cohort two of the OCU 400 clinical trial this month. Such statements are subject to numerous important risks, excuse me, factors, risks, and uncertainties, and 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 filing with Securities and Exchange Commission, SEC. including the risk factors described in the section entitled Risk Factors and the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as 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, OccuGEN's second quarter 10Q will be filed soon after today's call. I will now turn the call to Dr. Musunari.

Thank you, Tiffany. Good morning, everyone, and thank you for joining. We hope you and your families are safe and well. Courageous innovation is the driving force behind everything we do at OxyGEN. We are leading innovative clinical programs to ultimately make a significant impact on public health and address unmet medical needs around the globe. Developing great science requires harnessing the passion, persistence, patience, and intellectual prowess of our entire oxygen team, and I'm very proud of what we are accomplishing. Using this mindset of courageous innovation, we are strengthening our dedication to eye care, pursuing broader commercialization of our vaccines program, and we have expanded our pipeline into the orthopedic space, which we will discuss later. The oxygen team continues to charge ahead, and over the course of this past quarter, we saw great progress in establishing ourselves as a differentiated biotech company. As we continue to meet our regulatory milestones and engage with patients in a clinical setting, I'm especially confident that the team is well poised to advance our efforts. Today, we're going to provide updates on our vaccines, gene and cell therapy programs. Starting with vaccines. As we enter the third year of the COVID pandemic, We are facing new challenges as COVID-19 variants continue to emerge. At the World Vaccine Congress in late April, speakers all agreed that public health strategies need to expand and vaccine options beyond what is available in the current mRNA dominant landscape are necessary to contain the pandemic. This sentiment was reiterated during the recent White House summit on the future of COVID-19 vaccine. Additionally, consumers want effective options for vaccinating themselves and their children, including vaccines built on a traditional platform. We are up to this challenge as we advance the Covaxin program with our partner Biotech. Studies have shown Covaxin provides durability through immune memory and a broader immune response that may be important for realizing a booster strategy for annual vaccinations. We are still a few years away from seeing an end to this pandemic, and the need for delivering an additional COVID-19 vaccine option with a different MOA in the U.S. remains a priority. The Phase 2-3 immunobridging and broadening clinical trial, OCU-002 for Covaxin, is progressing well, and we are in the planning stages for starting the adult safety clinical trial this year, pending FDA discussions. Lancet Infectious Disease, which is a peer-reviewed journal, recently published the Phase 2-3 clinical trial results of 526 children who demonstrated a superior response in the study to that shown in adults. Nature Scientific Reports published a study where Covaxin generated a persistent cell-mediated memory immune response for up to 12 months. Additionally, it showed that a booster dose is safe and ensures persistent immunity to minimize breakthrough infections of COVID-19. These studies reinforce the point that Covaxin is effective with a favorable safety profile. Covaxin already has emergency use authorization in Mexico for adults, and we submitted an application for pediatric emergency use in the 2 to 18 age group that is under review. We are currently working on commercializing the vaccine in Mexico. Now, moving on to our gene therapy programs. And our founding focus, retinal diseases, is becoming clearer, especially with 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. Oxygen has a deep commitment to its research and development programs for inherited retinal diseases, for which there are no treatment options, only one gene therapy modality exists. Our modifier gene therapy, unlike traditional gene therapy, has shown in preclinical models to affect the regulation 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, including a family of inherited retinal diseases that cause blindness. We completed the dosing of subjects with retinitis pigmentosa in cohort one of our phase 1-2 safety and efficacy clinical trial for RQ400. And the independent data safety monitoring board for the clinical trial recommends proceeding to dosing in cohort two. We expect to begin dosing in cohort two this month and we will provide periodic updates. 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 and the ophthalmology disease space. By the end of this study, we will collect data from 18 patients which will constitute three cohorts of three different doses before moving on to a Phase III clinical trial. If successful, this therapy has the potential to treat many mutations under RP. Currently, RP has about 150 mutations, affecting approximately 2 million people globally. This is a dire, unmet medical need and shows where Octogen can bring courageous innovation to bear. Our sense of urgency for rescuing one site is critical, and for us, it's personal. Our next candidate, OCU410, has IND-enabling studies underway to support a future Phase 1-2 clinical trial targeting dry age-related macular degeneration. OCU410 is currently executing pre-IND studies consistent with FDA discussions to support a Phase 1-2 clinical trial, which the company intends to initiate next year. We have partnered with ConsinoBio to manufacture clinical trial materials and to support the CMC development for OCU-400 and OCU-410. It's also worth noting that we expanded our patent portfolio in June when the United States Patent and Trademarks Office issued the company an additional patent directed to methods for preventing or treating an ocular disease or disorder associated with retinal degenerative disease. Finally, we're expected to initiate a Phase 1-2A clinical trial next year for OCU-200, our novel biologic that has the potential to help those with diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration. We have completed the technology transfer of manufacturing processes to its contract development and manufacturing organization that will manufacture OCU-200 clinical materials. Now moving on to region-rated cell therapies. With the expansion of our pipeline into cell therapy and orthopedics, Neocort marks an experimental therapy with the potential to accelerate healing and reduce pain by rebuilding damaged knee cartilage and limiting the progression of osteoarthritis. Neocort is a tissue engineered disc of new cartilage that is manufactured by growing chondrocytes the cells responsible for maintaining cartilage health, which are derived from the patient. Recently, Opigen entered into a collaborative research agreement with Brigham and Women's Hospital, the teaching hospital of Harvard Medical School, to support neocard development and explore expansion of the pipeline. Earlier this year, the FDA granted a regenerative medicine advanced therapy, or RMAT, designation to neocard for the repair of full thickness lesions of the knee cartilage in adults. We believe this RMAT designation will accelerate our timeline in getting this product to market. Ocugen is currently working with the FDA to finalize the phase three clinical protocol necessary to advance the clinical development of Neocort for eventual market authorization. In summary, we have an ambitious clinical agenda and the rigor in our clinical development process to advance our pipeline in constant pursuit of our long-term vision. What's important to remember is that the strength of our pipeline is found in the diverse innovation we are exploring to address public health and unmet medical needs. I'm very proud of our team who collectively shares in our vision. We were recently named one of the region's best places to work by the Philadelphia Business Journal. This recognition is a reflection of all our colleagues and our culture focused on courageous innovation. I will now turn the call to Jess to provide our second quarter 2022 financial results.