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 Kenan Chowstee, Head of Investor Relations and Communications for Ocugen. You may begin.

Thank you, operator. I'd like to welcome you to our conference call. With me today is OccuGym's chairman and CEO, Dr. Shankar Musunuri, who will provide a business update, and our chief financial officer and head of corporate development, Sandre Subramanian, who will provide a financial update. Earlier this morning, we issued a press release including a business update and second quarter 2021 financial results. We encourage listeners to review the press release, which is available on our website at www.occugym.com. This call is also being recorded, and replay along with accompanying slide presentation will be available on the investor section of the Oxygen 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 Covaxin to the FDA, and whether and when we will receive regulatory approvals for Covaxin 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 and the quarterly and annual reports 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. I will now turn the call over to OccuGEN's Chairman and CEO, Dr. Shankar Musunmudi.

Thank you, Ken. Good morning everyone and thank you for joining and we hope you and your families are safe and well. We're now more than 18 months into coronavirus pandemic and we share the concerns of our public health officials of the risks and challenges posed by this mutating virus. The headlines speak every day to our fourth pandemic wave washing over many regions in the United States and we now have a pandemic of the unvaccinated that represents the vast majority of new cases surging through North America. It is really difficult to hear accounts of people in the hospital realizing too late that a vaccine and that taking well-known precautions could potentially have prevented serious illness and death. The same holds true for our friends in the North. Last week, the Public Health Agency of Canada, too, reported that almost 85% of recent reported COVID-19 cases across Canada are among those who are unvaccinated. Every day, My leadership team and I, along with the staff at Oxygen, discuss our role and potential contributions to the broader public health agenda and the fight against COVID-19. Just as I stated on our last call with you, our hearts go out to those who have lost loved ones or have been personally touched due to this virus. And our thoughts are also with the healthcare workers, public health officials, and scientists who are working every day to bring this pandemic back under control. Today, I would like to provide you an update on Archegent's achievements in conjunction with our co-development partner for Covaxin, Bharat Biotech, for the second quarter. We continue to believe that Covaxin, if approved, would be a critical addition to our national arsenal to fight this pandemic, and we believe that our efforts during the second quarter represent important steps forward toward bringing Covaxin to North America. All of this would not be possible without our collaboration with Bharat Biotech. As you know, these past months continue to be trying times for India. The demand for vaccines is great, and they have continuously been working to deliver for India and the 16 other countries in which Covaxin has been authorized and approved for use. For their work and partnership, we say thank you. On this slide, we have summarized the major events that have transpired over the second quarter of 2021. In June, Oxygen entered an amendment to our agreement with Barth Biotech that expanded our ability to develop, manufacture, and commercialize Covaxin into Canada, in addition to our existing rights in the United States. That was followed up with the discussions with Health Canada officials and led to our ability to file a regulatory submission under the interim order, which was transitioned into a new drug submission for COVID-19. We're extremely pleased that this was accomplished in such a short order, especially when the urgency is increasing in Canada. Now, the review has started. We are ready to answer their questions and will work with them throughout their review. It's important to note that Oxygen utilizes an affiliate called Vaxygen in Canada to help facilitate the submission and interaction with Health Canada. This affiliate will be responsible for the development and potential commercialization of Covaxin in Canada. I will discuss our engagement in the United States. As we stated in early June, the U.S. Food and Drug Administration directed us to submit a biological licensing application, or BLA, for Covaxin. The data requirements for Covaxin are still being evaluated. While we anticipate a need for an additional clinical trial, we're confident in our ability to navigate and address the FDA's process and requirements. Our partner, Park Biotech, posted compelling Phase III clinical data in early July, which are being evaluated for peer-reviewed publication. These data showed that Covaxin demonstrated an overall efficacy against COVID-19 at 77.8% and 93.4% against severe disease. Equally impressive is that this Phase III clinical trial was the first one to evaluate the efficacy of a COVID-19 vaccine against the Delta variant within a controlled setting. In fact, the majority of the symptomatic cases identified an aggregate in the Covaxin and control arms in the Phase III clinical trial for COVID-19 variants, the majority of which were identified to be Delta variant B.1.617.2. Data showed Covaxin achieving a 65.2% efficacy rate against the Delta variant. Data from COVID cases demonstrated low viral load, at least 104 less in vaccinated individuals compared to placebo group, showing potential for less transmission of the disease by individuals who received Covaxin. Furthermore, the data showed an efficacy against asymptomatic disease at 63.6%, suggesting the potential of the vaccine to reduce the asymptomatic spread of the disease. Finally, a readout of the safety data demonstrated that only 12.4% of participants in both the treatment and control zone control arms of the clinical trial reported an adverse event. Less than half a percent of participants reported a severe adverse event. The totality of this data raises two important points which make me optimistic about Covaxin serving a critical role in North America. First, these data on Delta are very suggestive that Covaxin is a valuable tool in our fight against this virus now. especially with this variant now dominating this fourth wave we are experiencing. This is a point we have been communicating to stakeholders, including FDA and Health Canada. Second, because this vaccine trains the immune system to attack the whole COVID-19 virus based on multi-antigens, including the spike and nucleocapsid proteins, Covaxin has the potential to be effective against multiple variants, and reduce the possibility of mutant virus escape. We recognize that this COVID-19 pandemic will continue to be a long-term challenge to our healthcare system and society, and such a multi-pronged ability to attack the virus so effectively has the potential to bring flexibility into our public health strategies. Providing Covaxin as an option, which is built on traditional platform, similar to polio vaccine, which has an established efficacy and safety record, may benefit many unvaccinated individuals and result in significant benefit to public health. On a final note about our progress for Covaxin, in June, Oxygen selected Jubilant Hollister, which is a renowned contract manufacturing organization, to be our partner for Covaxin to prepare for potential commercial manufacturing in North America. Technology transfer from Bharat Biotech to Jubilant has also been initiated. And as you saw back in March, we hired GP Gabriel as our head of manufacturing and supply chain, which he is now building out a team experienced in drug substance and drug product management, logistics and packaging, and procurement. This team is not solely focused on Covaxin, but will have supply chain responsibilities for our entire portfolio of assets. This rounds out our update on Covaxin. Now I'd like to turn our attention to our Ocular portfolio. We remain on track to initiate our first gene therapy Phase 1-2 clinical trial for Octu-400 later this year. These trials will be targeting two specific genome types, rhodopsin and NR2E3. Currently, our toxicology studies are progressing well with the readouts forthcoming. All of these will support an IND that we anticipate being filed in the fourth quarter. This has been a busy quarter with much going on behind the scenes to advance Covaxin and our Arculus portfolio. And there is much more ahead. I will now turn the call over to Sanjay to provide our second quarter 2021 financial update. Sanjay?