OCGN Ocugen, Inc.

6.96
+0.05  (+1%)
Previous Close 6.91
Open 6.79
52 Week Low 0.17
52 Week High 18.77
Market Cap $1,309,098,466
Shares 188,088,860
Float 182,859,115
Enterprise Value $1,278,145,424
Volume 18,158,211
Av. Daily Volume 65,966,904
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Upcoming Catalysts

Drug Stage Catalyst Date
OCU400 (AAV-NR2E3)
Retinitis Pigmentosa
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
COVAXIN
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 interim data from partner Bharat Biotech noted efficacy rate of 81% - March 3, 2021.
OCU 300
Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 trial stopped early due to insufficient efficacy - June 1, 2020.

Latest News

  1. MALVERN, Pa., March 29, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (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 announced that it will present at a virtual Fireside Chat hosted by Cantor Fitzgerald and Kristen Kluska, Biotechnology Analyst, on March 31, 2021 from 10:00 a.m. - 11:00 a.m. ET.

    Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen will participate along with members of the Ocugen Vaccine Scientific Advisory Board to discuss COVAXIN COVID-19 vaccine development. Topics will include:

    • Discussion on all COVAXIN safety and efficacy data generated to date from Bharat Biotech…

    MALVERN, Pa., March 29, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (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 announced that it will present at a virtual Fireside Chat hosted by Cantor Fitzgerald and Kristen Kluska, Biotechnology Analyst, on March 31, 2021 from 10:00 a.m. - 11:00 a.m. ET.

    Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen will participate along with members of the Ocugen Vaccine Scientific Advisory Board to discuss COVAXIN COVID-19 vaccine development. Topics will include:

    • Discussion on all COVAXIN safety and efficacy data generated to date from Bharat Biotech (private), including Phase 1, Phase 2, and interim Phase 3 data which demonstrated 81% efficacy.
    • Differentiation of COVAXIN (whole-virion inactivated vaccine) vs. other COVID-19 mRNA and adeno-based vaccines, including potential for coverage against multiple protein antigens of the virus.
    • Thoughts on the current pandemic situation including new variants emerging.
    • Highlight where the company views the greatest opportunity for COVAXIN in the United States, where they will receive 45% of the profits from any product sales.

    Ocugen's Vaccine Scientific Advisory Board members participating include: Satish Chandran, PhD – Wyeth Vaccines, Pfizer, Nucleonics, Somahlution; David Fajgenbaum, MD, MBA, MSc, FCPP – Translational Medicine & Human Genetics, University of Pennsylvania, Founding Director of Center for Cytokine Storm Treatment & Laboratory; and Bruce Forrest, MB, BS, MD, MBA – Wyeth Vaccines, Pfizer.

    Presentation Details:

    Format: Virtual Fireside Chat

    Date: March 31, 2021

    Time: 10:00 a.m. ET- 11:00 a.m. ET

    Registration Link: https://us02web.zoom.us/webinar/register/WN_DKZBH0wuRo-5udQpml48qg

    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.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is referenced in this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled "Risk Factors" in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

    Ocugen Contact:

    Ocugen, Inc.

    Sanjay Subramanian

    Chief Financial Officer and Head of Corporate Development

    Media Contact:

    LaVoieHealthScience

    Lisa DeScenza



    +1 9783955970



    Primary Logo

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  2. Conference Call and Webcast Today at 8:30 a.m. ET

    • 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

    MALVERN, Pa., March 18, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. ("Ocugen") (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene…

    Conference Call and Webcast Today at 8:30 a.m. ET

    • 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

    MALVERN, Pa., March 18, 2021 (GLOBE NEWSWIRE) -- 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.

    "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.

    Business Highlights:

    • 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.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data related to COVAXIN™), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration ("FDA") will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or EUA applications may be filed in the United States for COVAXIN™; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission ("SEC"), including the risk factors described in the section entitled "Risk Factors" in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

    This press release contains a preliminary estimate of Ocugen's cash, cash equivalents, and restricted cash as of February 28, 2021. The preliminary estimate should not be viewed as a substitute for interim financial statements prepared in accordance with U.S. generally accepted accounting principles. The preliminary estimate is based on preliminary unaudited information and management estimates as of February 28, 2021, is not a comprehensive statement of Ocugen's financial results, and is subject to the completion of Ocugen's financial closing procedures. As a result, this preliminary estimate may differ from the actual results that will be reflected in Ocugen's financial statements when they are completed and publicly disclosed. Additional information and disclosures would be required for a more complete understanding of Ocugen's financial position as of February 28, 2021. Ocugen's independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the preliminary estimate.

    Corporate Contact:

    Ocugen, Inc.

    Sanjay Subramanian

    Chief Financial Officer and Head of Corporate Development

    Media Contact:

    LaVoieHealthScience

    Lisa DeScenza



    +1 978-395-5970

    (tables to follow)



    OCUGEN, INC.

    CONSOLIDATED BALANCE SHEETS

    (UNAUDITED)

     December 31,

    2020
     December 31,

    2019
    Assets   
    Current assets   
    Cash and cash equivalents$24,039,325  $7,444,052 
    Prepaid expenses and other current assets1,838,357  1,322,167 
    Asset held for sale  7,000,000 
    Total current assets25,877,682  15,766,219 
    Property and equipment, net632,967  222,464 
    Restricted cash151,226  151,016 
    Other assets714,477  667,747 
    Total assets$27,376,352  $16,807,446 
    Liabilities and stockholders' equity   
    Current liabilities   
    Accounts payable$395,034  $1,895,613 
    Accrued expenses2,930,395  2,270,045 
    Short-term debt, net234,119   
    Operating lease obligation44,248  172,310 
    Other current liabilities9,755  205,991 
    Total current liabilities3,613,551  4,543,959 
    Non-current liabilities   
    Operating lease obligation, less current portion389,317  163,198 
    Long term debt, net1,823,043  1,072,123 
    Other non-current liabilities  9,755 
    Total liabilities5,825,911  5,789,035 
    Stockholders' equity   
    Common stock1,841,334  527,467 
    Treasury Stock(47,864) (47,864)
    Additional paid-in capital93,058,748  62,018,632 
    Accumulated deficit(73,301,777) (51,479,824)
    Total stockholders' equity21,550,441  11,018,411 
    Total liabilities and stockholders' equity$27,376,352  $16,807,446 
            



    OCUGEN, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (UNAUDITED)

     Year ended December 31,
     2020 2019
    Revenues   
    Collaboration revenue$42,620  $ 
    Total revenues42,620   
    Operating expenses   
    Research and development6,353,287  8,085,522 
    In-process research and development7,000,000   
    General and administrative7,974,050  6,077,097 
    Total operating expenses21,327,337  14,162,619 
    Loss from operations(21,284,717) (14,162,619)
    Other income (expense)   
    Change in fair value of derivative liabilities  (3,187,380)
    Loss on debt conversion  (341,136)
    Interest income1,065  1,214 
    Interest expense(720,963) (1,767,836)
    Other income (expense)182,662  (784,873)
    Total other income (expense)(537,236) (6,080,011)
    Net loss$(21,821,953) $(20,242,630)
    Deemed dividend related to Warrant Exchange(12,546,340)  
    Net loss to common stockholders$(34,368,293) $(20,242,630)
        
    Shares used in calculating net loss per common share — basic and diluted112,236,110  13,893,819 
    Net loss per share of common stock — basic and diluted$(0.31) $(1.46)
            


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  3. MALVERN, Pa., March 12, 2021 (GLOBE NEWSWIRE) -- 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 announced that it will host a conference call to discuss its 2020 financial results and provide a business update at 8:30 a.m. ET on Thursday, March 18, 2021.

    Ocugen will issue a pre-market earnings announcement the same day. Investors are invited to participate on the call using the following details:

     Dial-In Number:(844) 873-7330 (U.S.) or (602) 563-8473 (international)
     Conference ID:ID 2375087
     Webcast:Available in the "Investors" section of the Ocugen website by clicking

    MALVERN, Pa., March 12, 2021 (GLOBE NEWSWIRE) -- 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 announced that it will host a conference call to discuss its 2020 financial results and provide a business update at 8:30 a.m. ET on Thursday, March 18, 2021.

    Ocugen will issue a pre-market earnings announcement the same day. Investors are invited to participate on the call using the following details:

     Dial-In Number:(844) 873-7330 (U.S.) or (602) 563-8473 (international)
     Conference ID:ID 2375087
     Webcast:Available in the "Investors" section of the Ocugen website by clicking here and archived 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 International Limited's COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission ("SEC"), including the risk factors described in the section entitled "Risk Factors" in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

    Ocugen Contact:

    Ocugen, Inc.

    Sanjay Subramanian

    Chief Financial Officer and Head of Corporate Development

    Media Contact:

    LaVoieHealthScience

    Emmie Twombly



    +1 857-389-6042



    Primary Logo

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  4. MALVERN, Pa., March 08, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (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 announced that it will present at the H.C. Wainwright Global Life Sciences Conference being held on March 9-10, the 33rd Annual Roth Conference being held on March 15-17, and the Oppenheimer 31st Annual Healthcare Conference being held on March 16-18.

    Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will participate virtually at all three conferences. At HC Wainwright, he will participate in a fireside chat. At Roth he will participate in a COVID panel, and at Oppenheimer he will…

    MALVERN, Pa., March 08, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (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 announced that it will present at the H.C. Wainwright Global Life Sciences Conference being held on March 9-10, the 33rd Annual Roth Conference being held on March 15-17, and the Oppenheimer 31st Annual Healthcare Conference being held on March 16-18.

    Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will participate virtually at all three conferences. At HC Wainwright, he will participate in a fireside chat. At Roth he will participate in a COVID panel, and at Oppenheimer he will discuss the development of Ocugen's breakthrough modifier gene therapy, its novel biologic product candidate, and COVID-19 vaccine candidate, COVAXIN™ for the US market.

    Presentation Details:

    Conference: H.C. Wainwright Global Life Sciences Conference

    Format: Fireside Chat

    Date: Tuesday, March 9 – Wednesday, March 10, 2021

    Time: On demand beginning on March 9 at 7 a.m. EST

    Registration Link: https://journey.ct.events/view/ffe8580d-06ea-47a5-8bb8-c9bd92e65388

    Conference: 33rd Annual Roth Conference

    Format: Panel Entitled "Therapies and Vaccines In the Fight Against COVID-19"

    Date: Monday, March 15, 2021

    Time: 3 p.m. EST

    Conference Link: https://wsw.com/webcast/roth35/panel5/2041785

    Conference: Oppenheimer 31st Annual Healthcare Conference

    Format: Company Presentation

    Date: Tuesday, March 16, 2021

    Time: 11:20 a.m. - 11:50 a.m. EST

    Conference Link: https://wsw.com/webcast/oppenheimer9/ocgn/2703987

    About Ocugen, Inc.

    Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and develop 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.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled "Risk Factors" in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

    Ocugen Contact:

    Ocugen, Inc.

    Sanjay Subramanian

    Chief Financial Officer and Head of Corporate Development

    Media Contact:

    LaVoieHealthScience

    Emmie Twombly



    +1 857-389-6042



    Primary Logo

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    • Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose.

    • Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints.

    MALVERN, Pa., March 03, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (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 announced that its co-development partner…

    • Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose.



    • Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints.

    MALVERN, Pa., March 03, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (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 announced that its co-development partner, Bharat Biotech, announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy of 81%.

    "We are thrilled with the interim efficacy results of Bharat Biotech's Phase 3 trial of COVAXIN in India. These results, which in part suggest significant immunogenicity against the rapidly emerging UK variant, represent an additional step towards outlining the regulatory pathway for EUA and approval in the United States. COVAXIN, a whole virion based vaccine candidate, is designed to fill a significant unmet need in our national arsenal of vaccines against COVID-19," said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

    "Today's results from the interim analysis of Bharat Biotech's Phase 3 trial of COVAXIN mark a milestone in the development of another critical vaccine option for the US market. 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 ability of antibodies induced by COVAXIN to neutralize the UK variant of SARS-Cov-2," said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

    Interim Phase 3 Results as Reported by Bharat Biotech

    Bharat Biotech's Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on 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 first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6%.

    The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial's conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.

    Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.

    Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.

    About COVAXIN



    COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.



    In addition to generating strong immune response against multiple antigens, COVAXIN is shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8oC.

    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.

    About Bharat Biotech:

    Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

    Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world's first tetanus-toxoid conjugated vaccine for Typhoid.



    Bharat's commitment to global social innovation programs and public private partnerships resulted in the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit www.bharatbiotech.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled "Risk Factors" in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

    Ocugen Contact:

    Ocugen, Inc.

    Sanjay Subramanian

    Chief Financial Officer and Head of Corporate Development





    Media Contact:

    For Ocugen:

    LaVoieHealthScience

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