Ocugen reported 2Q21 loss of $26.0 million or $(0.13) per share, compared with our estimate of $7.7 million or $(0.04) per share. The difference was mostly due to a $15 licensing fee paid to Bharat Biotech for an amendment to expand Covaxin rights in Canada. Excluding this one-time payment, the loss would have been $11.0 million or $(0.06) per share. The company ended 2Q21 with $115.8 in total cash.Covaxin Continues To Make Progress Toward The Market. Ocugen reported that the review process for regulatory approval in Canada is underway. Bharat Biotech has selected Jubilant HollisterStier as its Covaxin manufacturing partner and has begun the technology transfer. The company is continuing discussions with the FDA regarding the requirements for BLA submission, although no new details were disclosed. Publication In A Medical Journal Would Raise Covaxin Awareness. Bharat Biotech has submitted its Phase 3 study for publication by a peer-reviewed publication. The world-wide interest in the COVID-19 vaccines, we expect it to be published in a widely-circulated medical journal. As the Delta variant has caused new outbreaks in both the unvaccinated population as well as breakthrough infection in vaccinated populations, this study has shown the vaccine’s efficacy against the Delta variant making its publication timely.Gene Therapy Pipeline Is Advancing To Clinical Trials. An IND filing for OCU400, the first product from Ocugen's gene therapy platform, is on schedule. The company is planning to begin two Phase 1/2a trials with OCU400 by year-end 2021. The first indications are expected to diseases affecting the retina, such retinitis pigmentosa and other inherited diseases.Conclusion: We have adjusted our estimates for the remaining quarters and FY2021 to reflect the outcome of the current quarters. We continue to see a need for continued vaccine programs to contain the COVID-19 outbreaks. Covaxin’s efficacy and safety, use of established technology, and its ease of distribution should lead use in vaccination programs upon approval. We value for Covaxin based on our estimated 2023 EPS of $1.73 per share, discounted at 30% per year, with a multiple of 15X for a price target of $15. Read More >>