• Research and Development Expenses: $8.3 million for Q4 2024, $32.1 million for the full year 2024.
• General and Administrative Expenses: $6.3 million for Q4 2024, $26.7 million for the full year 2024.
• Net Loss: $13.9 million or $0.05 per share for Q4 2024, $54.1 million or $0.20 per share for the full year 2024.
• Cash and Restricted Cash: $58.8 million as of December 31, 2024.

• Warning! GuruFocus has detected 3 Warning Signs with OCGN.

Release Date: March 05, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Ocugen Inc (NASDAQ:OCGN) has reached an alignment with the FDA to move forward with a Phase 2/3 pivotal confirmatory trial for OCU410ST, potentially expediting the clinical development timeline by two to three years.
• The company secured $65 million in equity and debt financings in the second half of 2024, extending its cash runway into the first quarter of 2026.
• OCU400, Ocugen's lead candidate, received a positive opinion from the European Medicines Agency for advanced therapy medicinal product classification, accelerating regulatory review timelines.
• Positive two-year safety and efficacy data from the OCU400 Phase 1/2 clinical trial demonstrated significant improvement in visual function, indicating long-term durability.
• Ocugen Inc (NASDAQ:OCGN) plans to file three potential Biologics License Applications (BLAs) over the next three years, showcasing a robust pipeline and strategic planning.

Negative Points

• Research and development expenses increased to $8.3 million for Q4 2024, up from $7.8 million in Q4 2023, indicating rising costs.
• General and administrative expenses also rose to $6.3 million for Q4 2024, compared to $5.2 million in Q4 2023.
• The company reported a net loss of $13.9 million for Q4 2024, an increase from the $11 million net loss in Q4 2023.
• Ocugen Inc (NASDAQ:OCGN) faces significant competition in the geographic atrophy market, with two approved therapies already available.
• The company's cash and restricted cash totaled $58.8 million as of December 31, 2024, which may require further financing to sustain long-term operations.

Q & A Highlights

Q: When considering your financial runway, does it account for the potential launch of new studies like the OCU410ST Phase 2/3? A: Yes, the budget already includes the costs for launching new studies such as the OCU410ST Phase 2/3. - Shankar Musunuri, CEO

Q: When can we expect data from the Phase 1 DME program, and what efficacy endpoints are being evaluated? A: We anticipate safety and efficacy data for OCU200 by the end of this year. We are evaluating safety, BCVA, dose response, antibody formation, and pharmacokinetics. - Tiffany Hamilton, Head of Communications

Q: What gives you confidence in achieving the target of filing three BLAs starting next year? A: Our track record shows significant progress since 2021. The FDA's support in converting trials to Phase 2/3 confirmatory trials for BLA filings boosts our confidence. We aim for BLA submissions for OCU400 in 2026, OCU410ST in 2027, and OCU410 in 2028. - Shankar Musunuri, CEO

Q: How will you convince physicians and patients to choose OCU410 over existing therapies for geographic atrophy? A: OCU410 offers a favorable safety and tolerability profile with no serious adverse events, unlike current treatments. It also requires fewer injections, which is appealing to both patients and physicians. - Huma Qamar, Chief Marketing Officer

Q: Will there be any grant revenue associated with the OCU500 Phase 1 trial? A: The NIAID is sponsoring the program, and we have completed our obligations. The funding for the Phase 1 trial will be managed by the agency, not recorded as revenue by Ocugen. - Shankar Musunuri, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.