MALVERN, Pa., Nov. 19, 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, biologics, and vaccines, today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD). Key findings include: no drug-related s ...

Ocugen (OCGN) came out with a quarterly loss of $0.05 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.06 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this biotech knee implant developer would post a loss of $0.06 per share when it actually produced a loss of $0.04, delivering a surprise of 33.33%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.Ocugen, which belongs to the ...

Financial Performance - Ocugen closed $30 million in debt financing and $35 million in equity financing during Q3 2024, extending its cash runway into Q1 2026[9]. - Total cash and restricted cash as of September 30, 2024, was $39.0 million, a slight decrease from $39.5 million as of December 31, 2023[9]. - Total operating expenses for Q3 2024 were $14.4 million, down from $16.1 million in Q3 2023, with R&D expenses at $8.1 million and G&A expenses at $6.3 million[10]. - The company reported a net loss of $12.97 million for Q3 2024, compared to a net loss of $11.72 million in Q3 2023[16]. - Total revenue for Q3 2024 was $1.14 million, a decrease from $3.70 million in Q3 2023[16]. Clinical Trials and Developments - The OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa is on track to complete enrollment in 1H2025, with an expanded access program allowing access to approximately 300,000 patients in the U.S., Canada, and Europe[2]. - OCU410 is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial, targeting geographic atrophy, which affects approximately 2-3 million people in the U.S. and EU[3]. - The FDA has approved the investigational new drug application for OCU200, with plans to initiate the Phase 1 clinical trial this quarter[8]. - The Data and Safety Monitoring Board approved enrollment for the second phase of the OCU410ST GARDian clinical trial[1]. - Ocugen plans to present new data on its clinical trials at an upcoming Clinical Showcase on November 12, 2024[6].

Subsequent to quarter-end, closed $30 million in debt financingOCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) on track to complete enrollment in 1H2025OCU410 is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial approved enrollment for the second phase of the Phase 1/2 clinical trialNew data on Phase 1/2 clinical trials for OCU410, OCU410ST and OCU400 to be presented at upcoming Clinical Showcase ...

MALVERN, Pa., Nov. 07, 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, biologics, and vaccines, today announced that on November 6, 2024, the Company entered into a new $30 million credit facility with Avenue Venture Opportunities Fund, L.P., a fund of Avenue Capital Group. Proceeds from the facility are intended for general corporate purposes, capital expenditures, wo ...

Core Insights - Ocugen, Inc. is hosting a Clinical Showcase on November 12, 2024, to present updates on its ongoing gene therapy trials for various retinal diseases [1][2] - The event will feature updates on the Phase 3 liMeliGhT clinical trial for retinitis pigmentosa, preliminary data from the Phase 1/2 OCU410 ArMaDa trial for geographic atrophy, and progress from the Phase 1/2 OCU410ST GARDian study for Stargardt disease [2][3] - Ocugen plans to initiate the Phase I clinical trial for its biologic candidate OCU200 for diabetic macular edema within the current quarter [2] Event Details - The Clinical Showcase will take place at the Nasdaq MarketSite in Times Square, New York City, from 10 a.m. to noon ET [1] - Presenters will include key executives and study investigators, providing insights into the clinical trials and patient experiences [3] Company Overview - Ocugen, Inc. focuses on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines aimed at improving health and addressing unmet medical needs [5] - The company is advancing research in multiple areas, including retinal diseases and infectious diseases, leveraging its breakthrough modifier gene therapy platform [5]

Determined the high dose of OCU410ST to be the maximum tolerated doseNo serious adverse events have been reportedApproved proceeding to Phase 2 using high and medium doses of OCU410ST MALVERN, Pa., Oct. 22, 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, biologics, and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian c ...

MALVERN, Pa., Oct. 17, 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, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company's third quarter 2024 financial results and provide a business update at 8:30 a.m. ET on Friday, November 8, 2024. Ocugen will issue a pre-market earnings announcement on the same day. ...

Core Viewpoint - Ocugen, Inc. has announced the lifting of the clinical hold by the FDA on its investigational new drug application for OCU200, a treatment for diabetic macular edema (DME) [1] Company Overview - Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines [5] - The company aims to improve health and offer hope for patients globally through innovative scientific approaches [5] Clinical Trial Details - The Phase 1 clinical trial for OCU200 is designed to treat patients with DME, targeting the underlying disease mechanisms through the integrin pathway [2][3] - The trial will be a multicenter, open-label, dose-ranging study with three cohorts assessing the safety of OCU200, and a fourth cohort combining OCU200 with anti-VEGF therapy [3] Disease Context - DME is a common vision-threatening disease affecting approximately 746,000 people in the United States, characterized by blurriness and progressive vision loss [4] - The prevalence of DME is increasing due to the rising number of diabetes cases in the U.S., making it crucial to address this condition [3] Future Indications - Ocugen intends to explore additional indications for OCU200, potentially treating diabetic retinopathy and wet age-related macular degeneration, which together affect nearly nine million Americans [4]

MALVERN, Pa., Oct. 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 Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen will present at the 2024 Cell & Gene Meeting on the Mesa being held October 7-9, 2024 at the Arizona Biltmore in Phoenix, AZ. "The Cell & Gene Meeting on the Mesa convenes industry de ...