MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has announced its financial results for the second quarter of 2024 and provided a business update.
Dr. Shankar Musunuri, Chairman, CEO, and Co-founder, highlighted key achievements. “The first half of 2024 has been marked with significant accomplishments for our modifier gene therapy platform—including dosing patients in the OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) and progressing into Phase 2 of the OCU410 ArMaDa clinical trial for the treatment of geographic atrophy (GA),” he said.
The OCU400 Phase 3 trial aims to treat 150 participants with RP, divided into two groups based on genetic mutations. The primary endpoint uses a Luminance Dependent Navigation Assessment (LDNA) to measure visual function. The FDA recently approved an expanded access program for OCU400, allowing treatment of adult patients with RP, regardless of mutation.
Ocugen’s novel gene therapies target multiple inherited retinal diseases and multifactorial causes of blindness. OCU410 and OCU410ST, for instance, address geographic atrophy and Stargardt disease, respectively. Both therapies use the RORA gene for potentially one-time treatments.
OCU410 offers advantages over current treatments for geographic atrophy, targeting multiple pathways with a single sub-retinal injection. OCU410ST has received Orphan Drug Designation from the FDA for Stargardt disease and is currently in its high-dose phase.
Ocugen is also pursuing strategic partnerships to expand access to its therapies globally. The company engaged with potential partners at the 2024 BIO International Convention.
Financially, Ocugen reported receiving $32.6 million from a recent public offering, extending its cash runway into the third quarter of 2025. The company had $16.0 million in cash and equivalents as of June 30, 2024, down from $39.5 million at the end of 2023. Operating expenses for the quarter were $16.6 million, compared to $24.0 million for the same period in 2023. The net loss per share was $0.04, an improvement from $0.10 the previous year.
Given Ocugen’s progress and financial health, analysts suggest the stock is a Hold. Investors should monitor trial outcomes and strategic developments.
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