EX-99.1 2 tm2622368d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ocugen Provides Business Update with Second Quarter 2026 Financial Results Conference Call and Webcast Today at 8:30 a.m. ET Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter ───────────────────────────────────────────────────────────────────────────────────────────────────── Granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility for priority review and accelerated approval Signed a binding term sheet with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, to negotiate an exclusive license for OCU400 in retinitis pigmentosa (RP) across the Middle East and North Africa (MENA) region Successfully completed OCU400 Process Performance Qualification (PPQ) batches, supporting Biologics License Application (BLA) and commercial launch supplies Closed $130.0 million convertible senior notes financing, extending cash runway into 2028 Remain …
Open exhibit ↗Current Report · Items 2.02, 9.01 · 8-K
Ocugen, Inc.
OCGNNASDAQEQUITYCurrent
Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition. On August 6, 2026, Ocugen, Inc (the “Company”) issued a press release announcing certain financial results for the quarter ended June 30, 2026. The Company has scheduled a conference call and webcast for 8:30 a.m. Eastern Time on August 6, 2026, to discuss these financial results and business updates.…
Company context
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.
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Disclosure sections
Item 2.02Item 2.02 - Results of Operations
Filed exhibits (2)
EX-99.2 3 tm2622368d1_ex99-2.htm EXHIBIT 99.2 Exhibit 99.2 Courageous Innovation Dedicated to Bringing Game-Changing Gene Therapies to Market and Working Even Harder to Provide Access to Patients Globally 2 Pipeline A quarter of execution across three programs Ocugen – Second Quarter Business Update OCU410ST Stargardt Disease 100K U.S.+EU patients · No approved therapy ODD · RPDD · OMPD · ATMP Current Stage Phase 2/3 GARDian3 — Enrollment complete Ph1 Ph2 Ph3 BLA Approved Next Catalysts Interim outcome analysis: 3Q 2026 Topline data: 2Q 2027 BLA target: Mid-2027 BLA 2027 OCU400 Retinitis Pigmentosa 300K U.S.+EU patients · 298K untreated RMAT · ODD · ATMP · OMPD Current Stage Phase 3 — Enrollment Complete Ph1 Ph2 Ph3 BLA Approved Next Catalysts Topline data: 1Q 2027 BLA target: 2Q 2027 BLA 2027 OCU410 Geographic Atrophy 2–3M U.S.+EU patients · No gene therapy approved RMAT · ATMP (EMA) Current Stage Phase 2 ARMADA Complete Ph1 Ph2 Ph3 BLA Approved Next Catalysts Phase 3 initiation: 3Q 2026 BLA target: 2028 BLA 2028 ──────────────────────────────────────────────── 3 Current GA th…
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