MALVERN, Pa., July 21, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced updates to its Retina Scientific Advisory Board (SAB) and Executive Leadership Team to enhance external guidance from key opinion leaders and strengthen the Company’s internal expertise in critical functions and as it pursues its goal of three BLAs in the next three years. “As our novel modifier gene therapy programs ...

MALVERN, Pa., July 18, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). “Dosing the first patient is an especially significant milestone and brings us closer to our goal of add ...

Company Overview - Ocugen, Inc. is a pioneering biotechnology leader focused on gene therapies for blindness diseases, utilizing a breakthrough modifier gene therapy platform to address significant unmet medical needs for large patient populations [3] Upcoming Events - The company will host a conference call and live webcast to discuss its second quarter 2025 financial results and provide a business update on August 1, 2025, at 8:30 a.m. ET [1] - A pre-market earnings announcement will be issued on the same day, with dial-in numbers provided for U.S. and international callers [2] Business Focus - Ocugen's modifier gene therapies aim to address complex diseases potentially caused by imbalances in multiple gene networks, with current programs in development for inherited retinal diseases and blindness diseases affecting millions globally, including retinitis pigmentosa, Stargardt disease, and geographic atrophy [3]

Core Viewpoint - Carisma Therapeutics Inc. and OrthoCellix, Inc. have announced a definitive merger agreement to combine in an all-stock transaction, focusing on the development of OrthoCellix's NeoCart® technology for knee cartilage defects and planning to initiate a Phase 3 clinical trial endorsed by the FDA [1][2][4]. Company Overview - Carisma Therapeutics is a biotechnology company specializing in macrophage engineering for therapies targeting fibrosis and cancer [11]. - OrthoCellix is a clinical-stage company developing regenerative cell therapies for orthopedic diseases, with its lead program being the NeoCart® technology aimed at repairing knee cartilage defects [10][3]. NeoCart® Technology - NeoCart® is an autologous cartilage implant technology that utilizes patient cells to repair articular cartilage defects, combining a fortified 3D scaffold with patented bioprocessing technology to produce functional cartilage [3][10]. - The technology has received Regenerative Medicine Advanced Therapy (RMAT) designation and FDA concurrence for a single, confirmatory Phase 3 clinical trial, which is anticipated to launch by the end of 2025 [4][6]. Merger Details - Under the merger agreement, OrthoCellix will merge into a wholly-owned subsidiary of Carisma, with OrthoCellix continuing as a subsidiary and the surviving entity [5][6]. - The merger will result in OrthoCellix stockholders owning approximately 90% of the combined company, while existing Carisma stockholders will own about 10%, subject to adjustments based on Carisma's net cash and financing proceeds [6][8]. Financial Aspects - Carisma plans to enter into subscription agreements for private financing with Ocugen and other investors to support the Phase 3 trial of NeoCart® without additional costs to Ocugen [5][6]. - The merger has been unanimously approved by the boards of both companies and is expected to close in the second half of 2025, pending customary closing conditions [8].

Company Overview - Ocugen Inc. is a clinical-stage biotechnology company focused on developing modifier gene therapies for rare inherited retinal diseases that lead to progressive vision loss [1]. Pipeline and Focus - The company is particularly concentrating on therapies for diseases that cause vision impairment, indicating a specialized approach within the biotechnology sector [1].

Core Viewpoint - Ocugen, Inc. has received FDA clearance to initiate a Phase 2/3 pivotal confirmatory trial for OCU410ST, a gene therapy candidate for Stargardt disease, highlighting the urgency for treatment options for patients with this condition [1][2]. Company Overview - Ocugen, Inc. is a biotechnology company focused on developing gene therapies for blindness diseases, utilizing a unique modifier gene therapy platform [10]. Clinical Trial Details - The Phase 2/3 trial will enroll 51 participants with Stargardt disease, with 34 receiving a subretinal injection of OCU410ST and 17 in a control group [3]. - The primary objective is to evaluate the reduction in atrophic lesion size, with secondary endpoints including improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) [3]. Regulatory Designations - OCU410ST has received Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation from the FDA, emphasizing the need for innovative treatments for ABCA4-associated retinopathies [1][4]. Patient Population - Approximately 100,000 patients in the U.S. and Europe, and 1 million globally, are affected by Stargardt disease, which is characterized by complex genetic mutations [4]. Clinical Data - Positive results from the Phase 1 GARDian trial indicated a 48% slower lesion growth at 12 months in treated eyes compared to untreated eyes, and a statistically significant improvement in visual function [6][7]. Future Plans - Ocugen plans to submit a Biologics License Application (BLA) for OCU410ST in 2027, aiming to file three BLAs over the next three years [5].

Core Insights - Ocugen, Inc. is set to present at the 2025 BIO International Convention, showcasing its innovative gene therapies for blindness diseases [1][2] - The company has recently executed a binding term sheet for exclusive rights to OCU400 in Korea, indicating a strategic partnership aimed at enhancing its market presence [3] - Ocugen's modifier gene therapy platform has achieved significant milestones, including FDA alignment for a pivotal trial and nearing completion of enrollment for the OCU400 Phase 3 clinical trial, with plans to file a Biologics License Application by mid-2026 [3] Company Overview - Ocugen, Inc. specializes in gene therapies for blindness diseases, focusing on inherited retinal diseases and conditions affecting millions globally, such as retinitis pigmentosa and Stargardt disease [6] - The company's modifier gene therapy platform is designed to address complex diseases caused by imbalances in multiple gene networks, distinguishing it from traditional gene therapies [6] Conference Details - Dr. Shankar Musunuri, Chairman and CEO, will present on June 16, 2025, and participate in panel discussions on optimizing clinical outcomes and navigating the regulatory landscape during the convention [4][5]

Core Viewpoint - Ocugen, Inc. has signed a binding term sheet to negotiate a licensing agreement for exclusive rights to its gene therapy OCU400 in Korea, aimed at treating retinitis pigmentosa (RP) [1][4]. Group 1: Licensing Agreement Details - The licensing agreement will provide Ocugen with upfront fees and near-term development milestones totaling up to $11 million [2][8]. - Ocugen will receive sales milestones of $1 million for every $15 million in net sales in Korea, along with a royalty of 25% on net sales generated by its partner [2][8]. - The company will manufacture the commercial supply of OCU400 under a supply agreement [2]. Group 2: Market Opportunity - There are approximately 15,000 individuals in South Korea affected by RP, presenting a significant market opportunity for the partner to lead in gene therapy [3]. - The regional licensing strategy aligns with Ocugen's goal to partner with established companies to maximize patient reach while generating returns for shareholders [4]. Group 3: Development Timeline - Ocugen is advancing OCU400 through Phase 3 clinical development, with a target for filing a Biologics License Application by mid-2026 [5].

Core Insights - Ocugen, Inc. has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for OCU410ST, aimed at treating ABCA4-associated retinopathies, including Stargardt disease [1][2] - The designation highlights the urgent need for therapeutic options for Stargardt patients, as there are currently no FDA-approved treatments available [2] - Approximately 100,000 individuals in the U.S. and Europe are affected by Stargardt disease, which primarily impacts children [2] Regulatory and Developmental Aspects - If the Priority Review Voucher (PRV) program is reauthorized, Ocugen may receive a PRV, which can be sold for about $100 million or used for expedited review of another product [3] - The company plans to initiate a Phase 2/3 pivotal confirmatory trial for OCU410ST in the coming weeks, with a target for Biologics License Application (BLA) filing in 2027 [4] Product and Technology Overview - OCU410ST employs an AAV delivery platform to deliver the RORA gene, representing a modifier gene therapy approach that addresses multiple pathophysiological pathways linked to Stargardt disease [5] - Stargardt disease is characterized by retinal degeneration and vision loss, primarily affecting the macula, leading to decreased central vision while some peripheral vision may be preserved [6][7] Company Background - Ocugen, Inc. is a biotechnology leader focused on gene therapies for blindness diseases, with a gene-agnostic approach that targets complex diseases caused by imbalances in multiple gene networks [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K ___________________________________________________________ CURRENT REPORT Pursuant to Section 13 OR 15 (d) of The Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): May 9, 2025 OCUGEN, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-36751 04-3522315 (State or Other Jurisdiction of Incorporation) (Commission File Number) (Address, including zip code, and telephone number, ...