Ocugen Meets A Pipeline Milestone Ocugen announced treatment of the first patient in its Phase 1/2 trial for OCU400, the first product from its gene therapy platform to reach clinical trials. OCU400 delivers genes to correct the genetic mutations that lead to retinitis pigmentosa, an ophthalmic condition that leads to vision loss and blindness. Patient screening began in 1Q22, meeting our expected timeframe for the trial. We see this milestone as good news for the product and the development pipeline.Phase 1/2 Trial Is Designed To Show Safety and Efficacy. The OCU400 Phase 1/2 trial is designed with three cohorts at increasing dose levels. After establishing basic safety at the low dose, two additional cohorts will receive higher doses. The treatment delivers functional copies of the NR2E3 and RHO genes, regulatory genes that affect expression of other genes in the disease pathway. Preliminary data is expected in 2H22.Covaxin Is Moving Forward Although Ocugen’s research and core business in in gene therapy, its best-known product is Covaxin. This in-licensed vaccine for COVID-19 is made using whole-killed virus technology. A Phase 2/3 Bridging study is in progress to demonstrate an immunological response in the US population to validate the data from the large Phase 3 trial conducted in India. An application for marketing approval is on schedule for submission in late 2022.Despite "Pandemic Fatigue", COVID-19 Has Not Gone Away Although the public sentiment has been shifting toward elimination of COVID-19 restrictions, additional variants continue to emerge. Mutations in the virus that causes COVID-19 are unpredictable, and like other viruses, the virulence of new strains is unpredictable. We continue to expect vaccination against COVID-19 to become part of routine medical practice.Conclusion. We see the start of patient treatment in the OCU400 trial as an important milestone for its development pipeline. Its other pipeline products for gene therapy, OCU410 and OCU200, are in preclinical development. These are for treating other genetic diseases of the eye, such as diabetic macular edema and age-related macular degeneration. We are reiterating our Outperform rating and price target of $15 per share. Read More >>