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.

Source: 10-Q filed 2026-08-06

“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…”

fact

Total liabilities of $141M exceed total assets of $124M as of 2026-06-30 — stockholders' equity is negative.

Source: balance sheet as of 2026-06-30 (XBRL)

Share count and dilution

fact

$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.

Source: 10-Q filed 2026-08-06

“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.

Source: antidilutive-securities disclosure, 10-Q filed 2026-08-06

Market

fact

No approved product carries Stargardt Disease on label.

Source: FDA label index

Trial registry

fact

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.

Source: ClinicalTrials.gov version history

fact

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.

Source: ClinicalTrials.gov record

Runway

fact

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.

Source: 10-Q filed 2026-08-06

Regulatory

fact

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

Source: 10-Q filed 2026-08-06

fact

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

Source: 10-Q filed 2026-08-06

“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

fact

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

Source: ClinicalTrials.gov, company as lead sponsor

fact

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

Source: 10-Q filed 2026-08-06

Ownership and proceedings

fact

Directors and executive officers as a group hold 3.95%.

Source: DEF 14A filed 2026-07-30

Don't see a name? Request a sheet. Any US-listed biotech with a Phase 3 or a pending FDA decision — it gets built the same way, from the filings.

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.