Earlier this week, Ocugen (OCGN) reported Q3’s financials. As the clinical stage biopharma company has no product to sell, investors were generally eager to glean insights on two subjects: the health of the company’s balance sheet and the progress of its drug pipeline, specifically in Ocugen’s case, the path forward for its Covid-19 vaccine Covaxin for which it has licensed the exclusive U.S. rights from India-based Bharat Biotech.
As for the former, the company saw out Q3 with $107 million in cash and cash equivalents, which H.C. Wainwright analyst Swayampakula Ramakanth believes is enough to keep operations going into 2023.
As for the latter, the company announced it had submitted with the FDA an EUA (Emergency Use Authorization) for Covaxin for pediatric patients between 2-18 years old. Ocugen’s submission is supported by a Phase 2/3 pediatric study which took place in India. The results from the study of 526 children 2-18 years old displayed similar immunogenicity outcomes to the adults in the larger Phase 3 study (in the adult study, Covaxin showed a 77.8% vaccine efficacy rate against symptomatic Covid infections and a 93.4% efficacy rate against severe disease).
Ramakanth senses there’s an opportunity for the vaccine to make its mark.
“We note that despite the approvals of several COVID-19 vaccines over the last two years, there still remains a significant unmet need in vaccines for pediatric patients, and if approved, COVAXIN could become one of the first options available, especially for children aged 2-4,” the 5-star analyst said.
The company also intends to move froward with a Phase 3 immuno-bridging study to show similarities between U.S. and Indian patients and will also pursue a BLA submission for Covaxin in adults. Ramakanth anticipates a US launch in 2H22.
In non-covid developments, the company has also put forward an IND for OCU400, Ocugen’s lead gene therapy candidate, to begin a Phase 1/2 study testing the drug as a treatment for retinitis pigmentosa resulting from genetic mutations found in NR2E3 and RHO. The company hopes to kick off the study before the end of the year.
“If this study is successful, management plans to follow up with a Phase 3 pivotal study of OCU400, which we believe could lead to a potential approval by 2025,” Ramakanth said.
To this end, the analyst has a Buy rating for OCGN shares, backed by a $10 price target. Investors could see returns of 16% should Ramakanth’s target be met in the year ahead. (To watch Ramakanth’s track record, click here)
Overall, 3 other analysts have chimed in with Ocugen reviews recently, of which 2 say Hold while the other says Buy, resulting in a Moderate Buy consensus view. Shares are expected to stay rangebound for the foreseeable future, given the average target currently stands at $8.75. (See OCGN stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
