Thank you, Lisa. Good morning, everyone, and thank you for joining. Since this time last year, when we hadn’t grasped the full impact of the pandemic and what it would mean in our daily lives. We at Ocugen have made it our personal mission to be part of the solution to help and COVID-19. Through our partnership with Bharat Biotech, a leading vaccine developer based in India, we are working to potentially bring the COVID-19 vaccine COVAXIN with United States. COVAXIN was developed in partnership between the Government of India and Bharat Biotech, and was granted approval for Emergency Use Authorization by the Indian authorities. And it’s currently part of the largest vaccine distribution program in the world. Several million people have received this vaccine in India. It has an excellent safety track record to-date leading journals, such as Nature and Lancet have published the rigorous scientific research conducted on COVAXIN to-date, which includes preclinical and human Phase 1 and Phase 2. COVAXIN provides an excellent opportunity for Ocugen to enter the infectious disease market. It is different from other COVID-19 vaccine options currently authorized for emergency use in the United States. These vaccines rely on new mRNA, or adenovirus technology, well, COVAXIN utilizes a traditional approach as an advanced stage whole-virion inactivated vaccine using a Vero Cell manufacturing platform. This is the same technology that has been successful in producing the polio vaccine for infants globally for decades.
Another key differentiator is that COVAXIN induces the immune system to target the whole wireless, which we believe reduces the possibility of mutant widest escape.
The other currently available options in the United States target just a spike antigen to illicit an antibody response, but COVAXIN has been shown to induce immune responses against multiple protein antigens, including the spike protein, receptor binding domain and the nucleocapsid protein of the SARS-CoV-2 virus along with the strong cellular responses.
In fact, data demonstrating COVAXIN’s ability to neutralize that UK variant of SARS-CoV-2 was published recently.
On the data front, on March 3, we announced that the COVAXIN respond to the 81% effective in an interim analysis of the Phase 3 clinical trial of nearly 26,000 participants in India. Not only did COVAXIN demonstrate the high clinical efficacy trends against COVID-19, but also sure significant immunogenicity against the rapidly emerging UK variant and has potential to be effective against other emerging variants too. The interim analysis included a preliminary review of the safety database, which short that severe, serious and medically attended adverse events occur at low levels and were balanced between vaccine and placebo groups. The Phase 3 trial, which is being conducted by Bharat Biotech will result in the final efficacy analysis at the 130 confirmed cases. Currently three EUAs for the other COVID-19 vaccine products in the United States do not authorize use in children under age 16. COVAXIN’s Phase 2 results cover adolescents ages 12 plus. There are over 16 million children in the U.S. between ages of 12 and 16, and most of them must attend middle school or high school.
We are planning to use our existing data to potentially cover this age group in our EUA, offering the potential significant immediate benefit to vaccinate children.
We will consider initiating U.S. clinical trials of COVAXIN in addition of patient populations, including pediatric and high-risk studies. Ocugen is in active discussions with the FDA to continue to develop the regulatory pathway for COVAXIN, vaccine candidate, EUA application. Based on our discussions, we are planning to file the EUA application in April on additional efficacy and safety data from Phase 3 clinical trial.
We’re also in discussions with BARDA, the Biomedical Advanced Research and Development Authority regarding their role in procuring medical counter measures of the strategic national stockpile. With regard to manufacturing, under our agreement with Bharat Biotech, they will supply the initial doses in the United States upon EUA approval. We’d already working with an FDA approved local CRO to establish release testing of the product for the U.S. market. Overall, we’re aiming to make up 200 million doses available this year to support the U.S. COVID-19 immunization program.
We’re in discussions with potential U.S. manufacturers and planning to work with Bharat Biotech on technology transfer, once the initial doses are supplied.
Importantly, COVAXIN offers additional benefits for stockpiling, storing and distribution, because it will be shipped in a ready to use liquid formulation. We’ll be able to use existing vaccine supply chain channels. COVAXIN had an expected shelf life of up to two years in a normal refrigerator temperature, and up to three months at room temperature. In summary, we are excited to collaborate with Bharat Biotech to develop the COVAXIN’s vaccine candidate for the U.S. market.
Our management team, as well as the vaccine scientific advisory board and highly experienced vaccine advisers, we assembled at Ocugen have a strong relationship with the leadership at Bharat Biotech. This is collaboration leverages Ocugen’s vaccine expertise and R&D manufacturing, regulatory and commercialization capabilities in the United States. Under the terms of the agreement, Ocugen will have the U.S. rights to the vaccine candidate. And we will be responsible for clinical development, regulatory approval including EVA and commercialization in the United States and we’ll retain 45% of the net profits.
Now we shift our discussion to ophthalmology pipeline.
We are on track to enter the clinic that our first gene therapy candidate OCU400, based on our modified gene therapy platform, which provides the potential to address multiple diseases with one product.
We are planning to file an IND to initiate two Phase 1/2 clinical trials later this year for gene mutation associated retinal diseases. In February, we announced that the European Commission granted orphan medicinal product designation for OCU400 for retinitis pigmentosa and leber congenital amaurosis, which we believe further, supports the potential of our modified gene therapy platform to treat many inherited diseases. Inherited retinal diseases associated with retinitis pigmentosa and leber congenital amaurosis diseases are caused by mutations in over 175 genes, and it is impractical to develop therapies that are specific to each gene. OCU400, a single product has potential to treat both RP and LCA, including all mutations associated with 175 genes.
On the manufacturing side for OCU400, we have completed our 200 liter commercial scale-up process.
Finally, the development of our novel biologic program OCU200 and gene therapy candidate OCU410 are both progressing well. And we are on track to be in the clinic for both programs next year. Since October 1, last year, we have raised gross proceeds of around $39 million through offerings of our common stock. And now we have a healthy balance sheet. We plan to continue to raise capital as needed to fund our COVAXIN development and ophthalmology pipeline development.
We’re also seeking potential funding from the U.S. government for COVAXIN development and supply. We made strong progress during 2020 toward our goals of developing differentiated vaccine to save lives from COVID-19 and developing gene therapies for blindness diseases. We look forward to continuing our momentum in 2021 with the planned U.S. rollout of COVAXIN, as well as filing an IND for OCU400 to move our first gene therapy program into the clinic. I will now turn the call over to Sanjay to provide our year end 2020 financial update. Sanjay?