Ocugen (OCGN) Q2 2024 earnings summary

Executive summary

• Significant progress in gene and cell therapy pipeline, including OCU400 Phase 3 for RP (first patient dosed June 2024), OCU410 Phase 2 for geographic atrophy, OCU410ST Phase 1/2, and NeoCart Phase 3-ready; OCU500 in early clinical collaboration.

• FDA approved expanded access program for OCU400, the first gene therapy EAP for RP regardless of mutation, in August 2024.

• Closed $32.6 million public offering, extending cash runway into Q3 2025; inclusion in Russell Index increases visibility and supports growth.

Financial highlights

• Cash, cash equivalents, and restricted cash totaled $16 million as of June 30, 2024, down from $39.5 million at year-end 2023.

• Q2 2024 revenue was $1.1 million, up from $0.5 million in Q2 2023; net loss for Q2 2024 was $15.3 million, improved from $23.1 million in Q2 2023.

• Operating expenses for Q2 2024 were $16.6 million, down from $24 million in Q2 2023; R&D expenses were $8.9 million, G&A expenses $7.7 million.

• Net loss per share for Q2 2024 was $0.04, compared to $0.10 in Q2 2023.

• 257.4 million shares of common stock outstanding as of June 30, 2024.

Outlook and guidance

• Cash runway extended into Q3 2025 following $32.6 million capital raise; additional funding needed for operations beyond that period.

• OCU400 Phase 3 LIMELIGHT trial on track for 2026 BLA and MAA submissions, with rolling submissions planned.

• OCU410 preliminary safety and efficacy data expected later in 2024.

• Management evaluating additional funding strategies, including equity/debt placements, partnerships, and grants.

• Substantial doubt exists about ability to continue as a going concern within one year without further financing.