Summary. Ocugen reported a net loss of $14.6 million or $(0.07) per share for 4Q21, bringing FY21 loss to $58.4 million or $(0.30) per share. The company also gave updates on recent developments for its development programs. Cash at December 31, 2021 was $95.1 million, excluding proceeds of an offering completed in late February 2022.Covaxin Is Progressing Through FDA and Heath Canada. The FDA lifted the Clinical Hold on the IND application for the Phase 2/3 clinical trial, allowing the bridging study to continue. The Emergency Use Authorization (EUA) application submitted in November 2022 has been supplemented with safety data and studies showing neutralization of the Delta and Omicron variants.Manufacturing Agreement Would Bring New Capacity. Ocugen expects to have the Covaxin manufacturing process completed, including regulatory qualification manufacturing lots, by mid-2022. It has also announced a Letter of Intent with Lininal BioSciences, Inc., a Canadian company, to acquire its vaccine manufacturing facility in Ontario. Gene Therapy Trial Recruiting Has Begun. OCU400 began recruiting patients for its Phase 1/2 clinical trial for Retinitis Pigmentosa in January 2022. OCU400 delivers, NR2E3, a master gene that controls downstream expression of other genes in the eye. The trial will have an open-label, dose escalation phase with preliminary data expected in 2H2022. Conclusion. We continue to expect Covaxin approval in both the US and Canada. Its production through standard vaccination methodology and long shelf life should make it a viable option for routine practice. We have adjusted our FY2022 estimates to reflect our expectations for product approvals in the US and Canada, and reiterate our Outperform rating and $15 price target. Read More >>