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Ocugen, Inc. (NASDAQ: OCGN) is a pioneering biotechnology company that focuses on discovering, developing, and commercializing novel gene and cell therapies, as well as vaccines aimed at improving health and offering hope to patients worldwide. The company's innovative efforts are concentrated on addressing rare and underserved ocular disorders.
Ocugen's core business revolves around a robust clinical pipeline which includes:
- OCU400: A groundbreaking gene-agnostic modifier gene therapy for retinitis pigmentosa (RP), currently in Phase 3 clinical trials. It leverages the nuclear hormone receptor gene NR2E3 to reset altered cellular gene networks and improve retinal health.
- OCU410: A potential one-time gene therapy for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). This therapy targets multiple pathways involved in the disease, including lipid metabolism, inflammation, oxidative stress, and the complement system.
- OCU410ST: Another modifier gene therapy in Phase 1/2 clinical trials for Stargardt disease, the most common form of inherited macular degeneration. It utilizes the AAV delivery platform for the RORA gene to regulate pathways linked to the disease.
Recent milestones include positive feedback from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the OCU400 Phase 3 liMeliGhT clinical trial, as well as the inclusion of Ocugen in the Russell 3000® Index, highlighting its market presence and growth potential.
Ocugen's commitment to innovative therapies is evident through its modifier gene therapy platforms designed to fulfill unmet medical needs related to inherited retinal diseases such as RP, Leber congenital amaurosis, and Stargardt disease. Additionally, the company is advancing research in infectious diseases to bolster public health and orthopedic diseases to meet unmet medical needs.
For the latest updates and detailed information about Ocugen, Inc., visit their official website at www.ocugen.com and follow them on X and LinkedIn.
Ocugen (NASDAQ: OCGN) announced the appointment of John Paul (J.P.) Gabriel as Senior Vice President of Manufacturing and Supply Chain. With over 25 years of experience, Gabriel has held key roles in leading biopharmaceutical companies, including Sanofi Pasteur and Pfizer Vaccines. His expertise will be vital in facilitating the U.S. manufacturing of COVAXIN, a COVID-19 vaccine candidate co-developed by Ocugen. Gabriel is expected to contribute significantly to the technology transfer from Bharat Biotech, enhancing Ocugen's capabilities in the vaccine sector.
Ocugen (NASDAQ: OCGN) announced its participation in a virtual Fireside Chat on March 31, 2021, with Cantor Fitzgerald. CEO Dr. Shankar Musunuri will discuss COVAXIN, a COVID-19 vaccine developed in collaboration with Bharat Biotech, highlighting safety and efficacy data, differences from mRNA vaccines, and pandemic conditions. The presentation aims to identify opportunities for COVAXIN in the U.S., where Ocugen expects to earn 45% of profits from sales.
Ocugen reports a productive year in 2020 with financial results indicating a net loss per share of $0.31, improving from a loss of $1.46 in 2019. The company has made significant strides in developing its COVID-19 vaccine candidate, COVAXIN™, which demonstrated 81% efficacy in Phase 3 trials. Ocugen is pursuing Emergency Use Authorization in the U.S. and has entered a co-development agreement with Bharat Biotech. Additionally, the EC granted orphan medicinal product designation for OCU400, signaling potential in treating retinal diseases. Cash reserves stand at approximately $46.6 million as of February 2021.
Ocugen has announced a conference call to discuss its financial results for 2020 on March 18, 2021, at 8:30 a.m. ET. The biopharmaceutical company focuses on gene therapies to treat blindness and is co-developing Bharat Biotech's COVAXIN for COVID-19 in the U.S. The pre-market earnings announcement will precede the call. Investors can participate via dial-in or webcast, accessible on Ocugen's website for 45 days post-call. This event highlights Ocugen's ongoing commitment to advancing its product candidates and financial transparency.
Ocugen, a biopharmaceutical firm, announced participation in three upcoming conferences: H.C. Wainwright Global Life Sciences Conference (Mar 9-10), 33rd Annual Roth Conference (Mar 15-17), and Oppenheimer 31st Annual Healthcare Conference (Mar 16-18). CEO Dr. Shankar Musunuri will present on COVID-19 vaccine COVAXIN™ and their gene therapy. The H.C. Wainwright conference features a fireside chat, while the Roth Conference includes a panel on COVID-19 therapies. Ocugen focuses on gene therapies for retinal diseases and COVAXIN for the U.S. market.
Ocugen announced promising results from Bharat Biotech's Phase 3 trial of COVAXIN, a COVID-19 vaccine, showing 81% efficacy in preventing symptomatic infections in over 25,800 participants. The interim analysis indicated that the vaccine was well tolerated with few adverse events. COVAXIN demonstrated the ability to neutralize the UK variant, underscoring its potential in the U.S. market. Further analyses are planned as the trial continues, aiming to finalize results at 130 confirmed cases.
Ocugen (NASDAQ: OCGN) has received orphan medicinal product designation from the European Commission for its gene therapy candidate OCU400, aimed at treating retinitis pigmentosa (RP) and Leber Congenital Amaurosis (LCA). The company estimates that RP affects 165,000 and LCA approximately 40,000 patients in Europe. OCU400 leverages a modifier gene therapy platform that could address multiple inherited retinal diseases, potentially benefiting millions globally. The designation provides significant advantages, including reduced regulatory fees and a decade of market exclusivity.
Ocugen, Inc. (Nasdaq: OCGN) has successfully completed a registered direct offering of 3,000,000 shares of common stock, generating approximately $23 million in gross proceeds. The offering was facilitated by H.C. Wainwright & Co. The funds will primarily support general corporate purposes, including capital expenditures and working capital. The shares were offered under a shelf registration statement filed with the SEC, ensuring compliance with regulatory standards.
Ocugen, Inc. (Nasdaq: OCGN) announced a registered direct offering of 3,000,000 shares of common stock at $7.65 per share, expecting gross proceeds of $23 million. The offering will close around February 10, 2021, subject to customary conditions. The funds raised will be allocated for general corporate purposes, capital expenditures, and working capital. H.C. Wainwright & Co. is the exclusive placement agent for this offering. The shares are being offered under an effective shelf registration statement with the SEC, ensuring compliance with securities laws.
Ocugen has chosen to withdraw a proposal regarding an increase in authorized shares previously set for stockholder consideration. This decision leads to the cancellation of the reconvening of the annual stockholder meeting, originally scheduled for January 13, 2021. The company plans to reassess this proposal in light of the potential inclusion of COVAXIN in its pipeline and its compliance with Nasdaq Listing Rule 5550(a)(2). Other items from the proxy statement were already voted on during the annual meeting on December 23, 2020.
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