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Ocugen Inc (OCGN)

Stargardt Disease · registered primary completion 2026-09-28 · NCT05956626

Published 2026-09-02Market cap $448M13 sourced statements
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease · PHASE2,PHASE3 · n=51 · active not recruiting

Balance sheet

fact

Management has concluded there is substantial doubt about the company's ability to continue as a going concern.

“cialization expenditures, and obligations and uncertainties related to the Company's financing arrangements, including conversion terms of the Convertible Notes. After evaluating these conditions and management's plans, the Company has concluded that there is substantial doubt about the Company's ability to continue as a going concern within one year after the date these condensed consolidated financial statements ar…”
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Total liabilities of $141M exceed total assets of $124M as of 2026-06-30 — stockholders' equity is negative.

Runway

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Cash of $100M against operating outflow of $16M per quarter gives roughly 6.1 quarters of runway, clearing the registered primary completion 0.4 quarters out by 5.7 quarters.

Share count and dilution

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$130M of convertible notes outstanding at 6.75%, maturing May 15, 2034. Conversion price $2.68 against a share price near $1.40 — 1.9x above the current price.

“tanding warrants, resulting in $ 14.2 million in net proceeds. In May 2026, the Company completed a private offering of $ 130.0 million aggregate principal amount of 6.75 % Convertible Senior Notes due 2034 ("Convertible Notes"), generating net proceeds of approximately $ 112.5 million after discounts, commissions, and offering expenses. The Company used approximately $ 32.7 million of the net proceeds from this offe…”
fact

339,110,401 shares outstanding against 461,506,849 if every outstanding option, warrant and convertible were exercised. In that case 26.5% of a gain in enterprise value would accrue to those holders rather than to current shareholders.

Market

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No approved product carries Stargardt Disease on label.

Trial registry

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The registered primary endpoint for NCT06388200 differs between the first version (2024-04-24) and the current one (2026-07-30), after the registered study start of 2024-06-18. Removed: Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA @ 52 weeks; Number of participants with change in functional vision in the study eye in…. Added: Change in functional vision from baseline to week 52 in pooled analysis when study eyes in treatment group were compared to study eyes in untreated control @ 52.

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Registered design for NCT05956626: randomized, single-masked, 51 participants (estimated). Primary outcome: Change from baseline in atrophic lesion size as measured by Fundus Auto Fluorescence. 1 further primary outcome(s) registered.

Regulatory

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Designations disclosed: RMAT, Breakthrough Therapy, Fast Track, Orphan Drug. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.

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The company has stated a potential approval target of fourth quarter of 2027.

“nt in the Phase 3 liMeliGhT clinical trial for OCU400 (N=140 subjects), reflecting strong interest from investigators and patients. Topline Phase 3 data is expected in the first quarter of 2027, advancing OCU400 towards potential approval in the fourth quarter of 2027 as a treatment option for early- to late stage RP. The U.S. Food and Drug Administration ("FDA") acknowledged the regulatory eligibility to rolling BLA…”

Pipeline

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4 distinct molecules in 6 active company-sponsored trials; OCU400 accounts for 5 of them at Phase 1/Phase 2/Phase 3.

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Programs receiving under $250k of research spend in the quarter: NeoCart, COVAXIN, Inhaled mucosal vaccine platform, OCU200.

Ownership and proceedings

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Directors and executive officers as a group hold 3.95%.

This sheet is dated and will not be edited. When the registered primary completion passes, its outcome is recorded on the scoreboard and a new dated sheet is published if the filings change materially.