PARIS--(BUSINESS WIRE)--Regulatory News: GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of September 30, 2025. Cash Position and Outlook GenSight Biologics' cash and cash equivalents totalled €0.6 million as of September 30, 2025. ...

Core Insights - Ocugen, Inc. is actively participating in key industry conferences to showcase its advancements in gene therapies for blindness diseases and aims to achieve three Biologics License Applications (BLAs) within the next three years [2][5] Group 1: Conference Participation - Ocugen's executive leadership will present at the 2025 Cell & Gene Meeting on the Mesa, Chardan's 9th Annual Genetic Medicines Conference, and the 2025 Maxim Growth Summit [1][4] - Dr. Shankar Musunuri, Chairman and CEO, will engage in discussions about the company's progress and potential partnerships during these events [2][4] - Specific presentation details include: - Cell & Gene Meeting on the Mesa: October 6, 2025, at 4 p.m. MST in Phoenix, AZ [3] - Chardan's 9th Annual Genetic Medicines Conference: October 21, 2025, from 9:30-10:10 a.m. EDT in New York, NY [3] - 2025 Maxim Growth Summit: October 22, 2025, from 3-4 p.m. EDT in New York, NY [4] Group 2: Company Overview - Ocugen is a biotechnology leader focused on gene therapies for blindness diseases, utilizing a modifier gene therapy platform that addresses complex diseases caused by imbalances in multiple gene networks [5] - The company is developing therapies for inherited retinal diseases, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, which affect millions globally [5]

Company Overview - Ocugen, Inc. is a biotechnology leader specializing in gene therapies for blindness diseases, focusing on a modifier gene therapy platform that addresses complex diseases caused by imbalances in multiple gene networks [5] Offering Details - The company closed a registered direct offering with Janus Henderson Investors for 20,000,000 shares of common stock at a price of $1.00 per share, along with warrants to purchase an additional 20,000,000 shares at an exercise price of $1.50 per share [1][3] - The gross proceeds from the offering were approximately $20 million, which is expected to extend the company's cash runway into the second quarter of 2026 [3] - If the warrants are fully exercised, the company could receive up to an additional $30 million, potentially extending the cash runway into the first quarter of 2027 [3] Financial Advisors - Noble Capital Markets, Inc. acted as the sole placement agent for the offering, while Maxim Group LLC and Titan Partners Group served as independent financial advisors [2]

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 Insights - Ocugen, Inc. is advancing its novel modifier gene therapies for blindness diseases, with a goal of filing three Biologics License Applications (BLA) or Marketing Authorization Applications (MAA) within the next three years [2][6] Financial Performance - As of March 31, 2025, the company's cash and restricted cash totaled $38.1 million, down from $58.8 million as of December 31, 2024 [12] - Total operating expenses for Q1 2025 were $16.0 million, compared to $13.2 million in Q1 2024, with research and development expenses increasing from $6.8 million to $9.5 million [12] - The net loss per common share for Q1 2025 was $0.05, consistent with the loss per share reported in Q1 2024 [12][19] Clinical Development Updates - The Phase 3 liMeliGhT clinical trial for OCU400, targeting retinitis pigmentosa (RP), is open to all eligible patients and aims to treat approximately 300,000 RP patients in the U.S. and EU [3][12] - The company has received FDA alignment to proceed with a Phase 2/3 pivotal trial for OCU410ST for Stargardt disease, which affects around 100,000 individuals in the U.S. and EU [4][12] - In the Phase 2 portion of the OCU410 trial for geographic atrophy (GA), treated subjects showed a 4-line (23-letter) gain in visual acuity and 41% slower GA lesion growth compared to untreated eyes [5][12] Regulatory Progress - All three modifier gene therapies have received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA), which accelerates the regulatory review process [6][12] - The EMA has provided a positive opinion for the ATMP classification of OCU400, allowing for a centralized MAA submission [12] Future Plans - Ocugen plans to initiate the Phase 2/3 study for OCU410ST by mid-2025, with a target BLA filing in 2027 [4][12] - The company is also preparing to complete the Phase 1 clinical trial for OCU200, its candidate for diabetic macular edema, in the second half of 2025 [9][12]

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 - Ocugen will host a conference call and live webcast to discuss its first quarter 2025 financial results and provide a business update on May 9, 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]. Product Development - The company is developing programs for inherited retinal diseases and blindness diseases affecting millions globally, including retinitis pigmentosa, Stargardt disease, and geographic atrophy [3].