Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today reported full year 2020 financial results along with a general business update.
- COVID-19 vaccine candidate, COVAXIN™, demonstrates efficacy of 81% in Phase 3 interim results
- Emergency Use Authorization pathway with U.S. regulatory authorities in development for COVAXIN™
- European Commission grants orphan medicinal product designation for OCU400 for retinitis pigmentosa and leber congenital amaurosis and Ocugen is on track to submit an Investigational New Drug application for OCU400 in 2021
- On track to initiate four Phase 1/2 clinical trials encompassing Ocugen’s ophthalmology pipeline in 2021 and 2022
“We made strong progress toward our goal of offering a differentiated vaccine to save lives from COVID-19 and in our work toward curing blindness diseases. We are actively working with U.S. regulatory authorities to develop a plan around Emergency Use Authorization in the United States for COVAXIN™ and are preparing to file an Investigational New Drug application to initiate our first two clinical trials for OCU400 in the second half of this year. Proceeds from our recent registered direct offering provide the financial resources to drive our COVAXIN™ development efforts and ophthalmology pipeline forward,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.
- Execution of Co-Development Agreement for COVAXIN™ in the U.S. Market – On February 2, 2021, Ocugen entered into a Co-Development, Supply and Commercialization Agreement with Bharat Biotech International Limited (“Bharat Biotech”) for the development and commercialization of COVAXIN™ in the U.S. market. Upon receipt of Emergency Use Authorization (“EUA”), Bharat Biotech will supply a specified minimum number of doses of COVAXIN™ and then support the technology transfer for manufacturing for the U.S. market. Ocugen will share the profits from the sale of COVAXIN™ in the U.S. market with Bharat Biotech, with Ocugen retaining 45% of the profits.
- Steady Progress to Develop EUA Pathway in the United States for COVAXIN™ Supported by U.S. Leading Experts in Vaccines – Key members of Ocugen’s management team and key advisors possess proven expertise and a track record of success in vaccine development and commercialization. Ocugen has established a vaccine scientific advisory board composed of leading academic and industry experts with extensive experience in the vaccine field. Collectively, the team is working with U.S. regulatory authorities to develop the regulatory pathway to EUA in the U.S. market.
- COVAXIN™ Demonstrates Efficacy of 81% in Phase 3 Interim Results – Interim results from Bharat Biotech’s Phase 3 trial in India showed that COVAXIN™ was well tolerated and demonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose. In addition, COVAXIN™ has been shown to induce immune responses against multiple protein antigens of the virus potentially reducing the possibility of mutant virus escape. This breadth of immune responses has been demonstrated by the ability of antibodies induced by COVAXIN™ to neutralize the U.K. variant of SARS-CoV-2. This broad-antigen containing vaccine has the potential to be effective against new emerging variants.
- First Gene Therapy Candidate OCU400 On Track to Enter the Clinic in 2H21 – Based on Ocugen’s modifier gene therapy platform, Ocugen’s product candidate OCU400 represents a novel approach in that it has the potential to address multiple retinal diseases with one product. Ocugen is planning to file an Investigational New Drug application to initiate two Phase 1/2 clinical trials of OCU400 later this year for the treatment of two disease genotypes.
- European Commission (“EC”) Grants Orphan Medicinal Product Designation for OCU400 for Retinitis Pigmentosa (“RP”) and Leber Congenital Amaurosis (“LCA”) – Designation by the EC further supports the potential broad spectrum application of OCU400 to treat many IRDs. IRDs associated with RP and LCA diseases are caused by mutations in over 175 genes, and it is impractical to develop therapies that are specific to each gene.
- Capital Raised – Ocugen’s cash, cash equivalents, and restricted cash totaled approximately $46.6 million as of February 28, 2021. Subsequent to December 31, 2020, Ocugen generated net proceeds of $4.8 million under an at-the-market offering and net proceeds of $21.2 million under a registered direct offering.
Full Year 2020 Financial Results:
- Ocugen’s cash, cash equivalents, and restricted cash totaled $24.2 million as of December 31, 2020, compared to $7.6 million as of December 31, 2019. The Company had 184.0 million shares of common stock outstanding as of December 31, 2020.
- Research and development expenses for the year ended December 31, 2020 were $6.4 million compared to $8.1 million for the year ended December 31, 2019. General and administrative expenses for the year ended December 31, 2020 were $8.0 million compared to $6.1 million for the year ended December 31, 2019. Ocugen reported a $0.31 net loss per share for the year ended December 31, 2020 compared to a $1.46 net loss per share for the year ended December 31, 2019.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 2375087. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.