MALVERN, Pa., May 02, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen will speak at the Retina World Congress (RWC) being held May 9-12, 2024 in Ft. Lauderdale, FL. "This is a terrific opportunity to share the most recent developments in modifier gene t ...

MALVERN, Pa., April 29, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Benjamin Bakall, MD, PhD, Director of Clinical Research at Associated Retina Consultants and Clinical Assistant Professor at the University of Arizona, College of Medicine—Phoenix will present data from the OCU400 Phase 1/2 clinical trial at the Retinal Cell and Gen ...

MALVERN, Pa., April 26, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410 for the treatment of geographic atrophy (Phase 1/2 ArMaDa clinical trial), and OCU410ST ...

MALVERN, Pa., April 26, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410 for the treatment of geographic atrophy (Phase 1/2 ArMaDa clinical trial), and OCU410ST ...

MALVERN, Pa., April 26, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410 for the treatment of geographic atrophy (Phase 1/2 ArMaDa clinical trial), and OCU410ST ...

Kanizphoto/iStock via Getty Images Ocugen, Inc. (NASDAQ:OCGN) has two upcoming data readouts expected in 2024, both of which could drive shareholder value higher. This would be regarding the use of OCU-410 and OCU-410ST, which are being advanced in phase 1/2 studies for the treatment of patients with Geographic Atrophy [GA], and Stargardt Disease, respectively. Preliminary data readouts from both of these studies are expected to be released in 2024. Should data from either of these studies turn out to b ...

Gene Therapy Development - The company is developing a modifier gene therapy platform targeting retinal diseases, with OCU400 receiving FDA clearance for a Phase 3 trial for retinitis pigmentosa (RP) expected to begin in Q2 2024[434][439]. - In the Phase 1/2 trial for OCU400, 89% of participants showed preservation or improvement in treated eyes, with 78% demonstrating stabilization or improvement in MLMT scores from baseline[438]. - The Phase 3 trial for OCU400 will enroll 150 subjects, with a 1:1 distribution into two arms (RHO: N=75, Gene Agnostic: N=75), and subjects will be followed for a year post-dosing[439]. - OCU410 and OCU410ST are in development for dry age-related macular degeneration (dAMD) and Stargardt disease, respectively, with OCU410 targeting multiple pathways for better safety and efficacy outcomes[442]. - OCU410 and OCU410ST programs are currently in Phase 1/2 clinical development, with the first patient dosed in November 2023 for Stargardt disease[454]. - The first patient for the OCU410 program targeting geographic atrophy was dosed in December 2023, with ongoing dosing in the Phase 1/2 trial[459]. Vaccine Development - The company is also advancing an inhaled mucosal vaccine platform, including OCU500 for COVID-19, with clinical trials expected to begin mid-2024[434]. - The inhaled mucosal vaccine platform includes OCU500, OCU510, and OCU520, with OCU500 selected for clinical trials by NIAID Project NextGen[482]. - The company is collaborating with NIAID for early clinical studies of OCU500 and is planning to submit an IND in 2024[434]. - The company faces challenges in sourcing raw materials for vaccine production, which could impact clinical trials and manufacturing timelines[460]. - The company is actively seeking government funding for the development of its vaccine candidates, which is crucial for commercialization[482]. Regulatory and Financial Challenges - The FDA has provided Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) designation for OCU400, supporting its broad therapeutic potential[436]. - The EMA has reviewed the Phase 3 trial design for OCU400 and provided acceptability for submission of a Marketing Authorization Application (MAA)[440]. - Regulatory challenges may impact the approval process and commercialization of product candidates, potentially affecting the company's financial position[445]. - The FDA has placed the IND application for OCU200 on clinical hold, pending additional information related to CMC[480]. - OCU400 and OCU410ST have received orphan drug designations from the FDA, but there is no guarantee of maintaining these designations[462]. Financial Performance - The company incurred net losses of approximately $63.1 million and $86.8 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $286.2 million as of December 31, 2023[483][499]. - Total revenue for the year ended December 31, 2023 was $6.036 million, an increase of $3.548 million compared to $2.488 million for the year ended December 31, 2022[492][493]. - Research and development expenses decreased by $16.586 million to $39.573 million for the year ended December 31, 2023, primarily due to the termination of the COVAXIN program and reduced activities for OCU200 and OCU400[492][494]. - General and administrative expenses decreased by $3.406 million to $31.994 million for the year ended December 31, 2023, mainly due to reductions in consulting and pre-commercial expenses[492][496]. - Cash used in operating activities was $62.1 million for the year ended December 31, 2023, compared to $60.1 million for the year ended December 31, 2022[505][506]. - The company raised an aggregate of $301.0 million since inception, with $287.2 million from the sale of common stock and warrants as of December 31, 2023[503]. - Cash provided by financing activities was $20.9 million for the year ended December 31, 2023, a decrease from $59.5 million for the year ended December 31, 2022[509]. - The company had cash and cash equivalents of $39.5 million as of December 31, 2023[503]. - As of December 31, 2023, the company had cash and cash equivalents of approximately $39.5 million, which is insufficient to meet capital requirements over the next 12 months[518]. - The company anticipates needing to raise significant additional capital to fund operations until it recognizes significant revenue from product sales[518]. - Stock-based compensation expense was $9.2 million for the year ended December 31, 2023, down from $10.5 million in 2022[534]. - The company expects to recognize $8.6 million of unrecognized stock-based compensation expense over a remaining weighted-average period of 1.5 years[534]. - The company has borrowed $2.5 million from EB-5 Life Sciences under the U.S. government's Immigrant Investor Program[512]. - Future minimum operating lease base rent payment obligations amounted to $5.8 million as of December 31, 2023[511]. - There is substantial doubt about the company's ability to continue as a going concern within one year after the issuance of the consolidated financial statements[519]. Operational Developments - The company has completed renovations to a facility to support clinical studies and initial commercial launch of its regenerative medicine cell therapy platform[434]. - The company is developing NeoCart, a regenerative medicine cell therapy, with plans to initiate a Phase 3 trial in the second half of 2024, contingent on funding availability[481]. - The company terminated the Canada Consulting Agreement in June 2023 due to the FDA canceling all EUAs for monovalent COVID-19 vaccine formulations[513]. - The company is exploring various strategies for funding, including public and private placements of equity and/or debt, and potential collaborations with pharmaceutical companies[518]. - The company has no off-balance sheet arrangements during the periods presented[520].

MALVERN, Pa., April 12, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will participate in a fireside chat during the Emerging Growth Virtual Healthcare Equity Conference, presented by Noble Capital Markets, taking place from April 17 – 18, 2024. Details of the fireside chat are ...

MALVERN, Pa., April 10, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the pivotal OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) and provi ...

Ocugen, Inc. (OCGN) announced that the Data and Safety Monitoring Board (“DSMB”) for the early to mid-stage study of its investigational candidate, OCU410, has approved the initiation of dosing with the medium dose of OCU410 in the dose-escalation phase of the study to treatpatients with geographic atrophy (GA). Per management, this marks a critical step forward in determiningthe optimal dosing regimen of OCU410.The company’s shares jumped 21.2% in the last trading session on Apr 5 and continued to gain ano ...