Biopharmaceutical company Ocugen Inc. (OCGN:NASDAQ), which focuses on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that "it has entered into definitive agreements with healthcare-focused institutional investors for the sale of an aggregate of 10 million shares of its common stock at a purchase price of $10 per share in a registered direct offering." The firm indicated that the transaction is subject to certain ordinary closing conditions and that it anticipates the offering will close by Tuesday, April 27, 2021.
The company advised that it expects to receive approximately $100 million in gross proceeds from the share offering before paying associated placement agent's fees and related offering expenses. Ocugen noted that it plans to utilize the net proceeds received from the offering for "general corporate purposes, capital expenditures, working capital and general and administrative expenses."
Earlier this week the company announced that "its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate." Ocugen stated in the report that "COVAXIN demonstrated a vaccine efficacy in mild, moderate and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease alone of 100%."
The company's Chairman, CEO and Co-founder Dr. Shankar Musunuri commented, "We continue to be excited by the compelling second interim results of Bharat Biotech's Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date...Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic."
Ocugen's Scientific Advisory Board Member Dr. Bruce Forrest remarked, "The safety and efficacy demonstrated by COVAXIN is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children."
Ocugen noted Bharat Biotech enrolled 25,800 individuals in India between 18 to 91 years old to take part in a Phase 3 clinical trial. The study included 2,433 individuals over the age of 60 and 4,500 with comorbidities. The trial's primary endpoint was "the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline."
The second interim analysis was prepared based up data from 127 symptomatic COVID-19 cases recorded. The results from this review showed an estimated vaccine efficacy rate of 78% against mild, moderate and severe COVID-19 disease. The company stated that "the efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test."
COVAXIN was described in the report as "India's COVID-19 vaccine." The report explained that the vaccine was developed by Bharat Biotech together with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). To date, greater than 300 million doses of the vaccine have been supplied. The reported noted that not only does COVAXIN generate a strong immune response against multiple antigens, but it also has demonstrated to generate specific memory T cell responses that are also capable of responding to future infections.
Ocugen, Inc. concentrates on developing and commercializing gene therapies for severe eye diseases and is currently actively engaged in developing a vaccine for use against COVID-19. The firm listed that its modifier gene therapy platform can potentially treat multiple retinal diseases with one drug employing a "one to many" approach. The company is working to develop treatments for underserved areas of ophthalmology including diabetic macular edema, diabetic retinopathy and wet age-related macular degeneration. Additionally, Ocugen is now co-developing Bharat Biotech's COVAXIN vaccine candidate for use against COVID-19 in the U.S.
Ocugen began the day with a market capitalization of around $1.7 billion with approximately 188.1 million shares outstanding and a short interest of about 14.4%. OCGN shares opened 4% higher today at $9.68 (+$0.39, +4.20%) over yesterday's $9.29 closing price. The stock traded today between $8.70 and $13.65 per share and closed for trading at $9.63 (+$0.34, +3.66%).
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