Ocugen (OCGN) Q1 2026 earnings summary

Executive summary

• Announced $115 million convertible senior notes offering, expected to extend cash runway into 2028, with potential for an additional $15 million from warrant exercises; $32.7 million of proceeds used to retire Avenue debt.

• Advanced three late-stage gene therapy programs (OCU400, OCU410, OCU410ST) for major retinal diseases, with over 250 patients treated and no drug-related serious adverse events observed.

• Achieved key milestones: positive phase II data for OCU410 in GA (31% lesion reduction, 27% EZ preservation), completed pivotal trial enrollments for OCU400 (RP) and OCU410ST (Stargardt), and on track for up to three BLA submissions by 2028.

• Robust business development activities and global commercialization preparation, including ex-U.S. licensing discussions and participation in major industry conferences.

Financial highlights

• Total operating expenses for Q1 2026 were $19.4 million, up from $16 million in Q1 2025, driven by increased R&D and G&A expenses.

• Net loss for Q1 2026 was $19.2 million, or $0.06 per share, compared to $15.4 million, or $0.05 per share, in Q1 2025.

• Cash, cash equivalents, and restricted cash totaled $32.2 million as of March 31, 2026, up from $18.9 million a year prior; expected to reach $112.1 million post-offering.

• Received $37.5 million in gross proceeds in Q1 2026, including $15 million from exercised warrants.

• Collaborative arrangement revenue was $1.53 million, up $0.05 million year-over-year.

Outlook and guidance

• Cash runway expected to extend into 2028, covering planned phase III trials and commercialization activities.

• Rolling BLA submission for OCU400 (RP) to begin in Q3 2026, with full submission by Q2 2027 and potential FDA approval in Q4 2027.

• OCU410ST (Stargardt) phase II/III interim analysis in Q3 2026, top-line results in Q2 2027, and BLA submission by mid-2027.

• OCU410 (GA) phase III trial design alignment with FDA/EMA expected by Q3 2026, with BLA filing targeted by 2028.

• Substantial doubt exists about the ability to continue as a going concern for the next 12 months without additional funding.