Biotech Co. Advances 3 New Clinical Stage Assets

Ocugen Inc.’s new diverse product candidates include a COVID vaccine, a gene therapeutic for retinitis pigmentosa, and a cell therapy to prevent osteoarthritis, noted a ROTH Capital Partners report.

Ocugen Inc.’s (OCGN:NASDAQ) initial valuation will be driven by its gene therapeutic, OCU400, and the COVID vaccine, COVAXIN, purported ROTH Capital Partners analyst Jonathan Aschoff in a June 15 research note.

ROTH recently resumed analyst coverage of Ocugen with Aschoff taking it over. With that, the investment bank developed fresh financial projections and established a new target price on the biotech, of $8 per share. Ocugen’s current share price, in comparison, is around $1.90.

ROTH based its target price on future commercial success of and projected revenue from COVAXIN in the U.S. and from OCU400 in the U.S. and the EU5 countries.

“As such, we believe that there is substantial room for potential upside to these projections,” Aschoff wrote.

Ocugen, based in Pennsylvania, U.S.A., is focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines in the therapeutic areas of eye, infectious and orthopedic diseases.

Regarding OCU400, Aschoff relayed, that enrollment is underway for a Phase 1/2 dose escalation and safety trial of this modifier gene therapeutic in retinitis pigmentosa that results from mutations in the NR2E3 and RHO genes.

Because OCU400 targets a nuclear hormone receptor that regulates multiple functions in the retina, it potentially could treat retinal diseases caused by several gene mutations, noted Aschoff.

“The program could potentially be expanded to include additional genetic mutations in Phase 3 to evaluate OCU400 in both retinitis pigmentosa and Leber congenital amaurosis,” the analyst added.

As for COVAXIN, Ocugen has the complete North American rights to it, where the vaccine is currently authorized for emergency use in adults and is under review for the same in children, wrote Aschoff.

The biotech plans to resume its Phase 2/3 immuno-bridging and broadening trial of COVAXIN in the U.S. It also intends to finalize, with input from the U.S. Food and Drug Administration (FDA), additional studies needed to file, with the agency, a biologics license application for the vaccine.

Ocugen is also in discussions with Health Canada about funding to acquire Liminal BioScience’s manufacturing facility in Ontario, Aschoff indicated. Ocugen envisions using this plant for research and for manufacturing COVAXIN, its gene therapies, and the other product candidates in its existing and future pipelines.

Finally, Ocugen is advancing its autologous neocartilage cell therapy platform, NeoCart, currently designing a Phase 3 program for it. NeoCart is designed to repair full-thickness lesions in adult knee cartilage to prevent osteoarthritis. For this indication, NeoCart currently has the FDA’s regenerative medicine advanced therapy designation.

“NeoCart has the potential to accelerate healing and reduce pain by rebuilding damaged knee cartilage back to how it was before the injury,” Aschoff commented.

Regarding Ocugen’s financial status, the analyst highlighted that the biotech has sufficient cash, $129.9 million as of the end of Q1/22, to fund operations past the readouts of the COVAXIN immuno-bridging trial and the OCU400 safety study, into 2023.

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Disclosures for Roth Capital Partners, Ocugen Inc., June 15, 2022

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

General Disclosures: ROTH makes a market in shares of Ocugen, Inc. and as such, buys and sells from customers on a principal basis. Shares of Ocugen Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH.