MALVERN, Pa. , Feb. 25, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen) (NASDAQ:OCGN), a clinical-stage biopharmaceutical company focused on the discovery, progression and commercialization of genetic treatments to cure blindness and soon a life-saving vaccine for COVID-19, released fourth-quarter and full-year monetary effects and a general business update.
“The fourth quarter capped a year of transformative expansion for Ocugen as we saw major progress across our portfolio. The clinical blockade of the COVAXIN™ progression program was removed and we strengthened our application for pediatric emergency use authorization from the U. S. Department of Food and Drug. USA Administration with a protection database of more than 36 million adolescents vaccinated with COVAXIN™. Our lead candidate for the genetic modification treatment platform, OCU400, obtained approval to initiate a Phase 1/2 clinical trial on the target. I am very pleased with the perseverance and commitment of the Ocugen team and the achievements it has achieved so far. 2022 is about to be a wonderful year for the company. We are excited to begin those clinical trials and will provide regular updates in the future,” said Dr. Shankar Musunuri, President, CEO and Co-Founder of Ocugen.
Commercial Updates
Financial Results 2021
Ocugen has scheduled a convention call and webcast at 8:30 a. m. ET to discuss recent currency effects and business highlights. The Ocugen monitoring team will lead the call, which will be open to all listeners. reply to query after comments ready.
The call can be made by dialing (844) 873-7330 (USA) or (602) 563-8473 (international) and offering the convention ID 4071887. For a live audio webcast of the call on the “Investors” segment of the Ocugen Website, click here. A repeat of the webcast on the Ocugen online page will be archived for approximately forty-five days after the call.
About Ocugen, Inc. Ocugen, Inc. es a clinical-stage biopharmaceutical company whose goal is the discovery, progression and commercialization of genetic treatments to cure the diseases of blindness and the progression of a life-saving vaccine opposed to COVID-19. Our revolutionary gene modifier treatment platform has the possibility to treat retinal diseases with a single drug: “one to many” and our new biologic candidate aims to offer better treatment to patients with neglected diseases, such as age-related macular degeneration, diabetes, macular edema and diabetes. retinopathy. We are jointly developing Bharat Biotech International Limited’s (Bharat Biotech) COVAXIN™ vaccine candidate for COVID-19 in the US markets. For more information, visit www. ocugen. com.
Caution Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to threats and uncertainties. Ocugen possibly, in some cases, use terms such as “predicts”, “believes”, “prospective”, “proposed”, “continues”, “estimates”, “anticipates”, “expects”, “plans” Array “intends, ” possibly,” “may also just,” “may also just,” “will,” “should” or other words that express uncertainty of long-term events or effects to identify those forward-looking statements. These forward-looking statements come with on Ocugen’s progress in advancing COVAXIN™ review with the FDA, adding regarding its US submission for COVAXIN™ for pediatric use, and data on its non-binding letter of intent with Liminal to obtain the site of production of Liminal in Belleville, Ontario, and are subject to threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied through such representations, including, among other things, the threat that Ocugen possible entity would not be able to successfully negotiate and execute in full the definitive transaction agreements for the acquisition of the Liminal production site on tradable terms, if any, and the final terms and timeframes for the final weighted transactions; the threat that Ocugen may not be able to successfully complete the acquisition of the Liminal production site; threats related to the planned advancement and renovation of the production site, adding that the expected prices for such advancement will be higher than recently weighted or that the planned advancement will take longer than expected or will not be completed as scheduled , if it does ; and the threat that Ocugen may not be able to adapt the production of this site to adequately support its applicants’ manufacture of products or other products that are recently or potentially long-term manufactured at this site. In addition, Ocugen’s business is subject to other threats and uncertainties, including, among other things, the uncertainties inherent in studies and progression, including the ability to achieve expected clinical effects, start and/or end dates of clinical trials. , regulatory filing dates, regulatory approval dates and/or start dates; the threat that Health Canada may not comply with its NDS for COVAXIN™ or that Ocugen may not be able to adequately address known deficiencies through Health Canada with respect to its NDS, for which Ocugen has provided responses that are lately under review through Health Canada; the threat that the FDA may make other decisions that will have a negative effect on its ability to further the progression of COVAXIN™ in the United States, even if the FDA’s clinical hold on Ocugen’s IND application for COVAXIN™ is lifted ; threats related to initial and provisional knowledge, adding the option of new adverse clinical trial knowledge and additional analyzes of existing clinical trial knowledge; the threat that the effects of in vitro studies will not be duplicated in human clinical trials; the threat that knowledge of clinical trials will be subject to different interpretations and evaluations, aggregating during the publication/peer review process, in the wider clinical network and through regulatory authorities; whether and when Bharat Biotech’s clinical trial knowledge will be published in clinical journals and, if so, when and with what modifications; whether the knowledge and effects of the preclinical and clinical studies of COVAXIN™, which were conducted through Bharat Biotech in India, will be resolved through the FDA or Health Canada or will be sufficient to assist in its US submission, expected presentation of BLA or NDS; the size, scope, timing, and effects of any additional clinical trials or studies that Ocugen may be required to conduct to assist an EUA or BLA; any additional chemistry, production, and controls data that Ocugen may need to submit to the FDA or Health Canada; if and when a BLA for COVAXIN™ will be filed with or approved by the FDA; whether progressions related to the COVID-19 pandemic will have effects on the regulatory pathway for vaccines in the United States, Canada, or other jurisdictions; market call for COVAXIN™ in the United States or Canada; Decisions by the FDA or Health Canada have an effect on labeling, production procedures, protection, and/or other issues that could affect the availability or prospective advertising of COVAXIN™ in the United States or Canada, as well as the progression of products or treatments through other companies. . These and other threats and uncertainties are described in more detail in Ocugen’s periodic filings with the Securities and Exchange Commission (SEC), adding the threat items described in the segment titled “Risk Factors. ” in its quarterly and annual reports filed with the SEC. All forward-looking statements made by Ocugen in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes no legal responsibility to update any forward-looking statements contained in this press release, whether as a result of new data, long-term events or otherwise, after the date of this press release. press.
Ocugen Contact: Ken Inchausti Investor Relations and Communications Manager 1,484,237 3398ken. inchausti@ocugen. com
Please program investors to: IR@ocugen. com
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