The following is a summary of the Celcuity Inc. (CELC) Q3 2024 Earnings Call Transcript:

Financial Performance:

• Celcuity reported a net loss of $29.8 million, or $0.70 per share for Q3 2024, compared to a net loss of $18.4 million, or $0.83 per share for Q3 2023.

• Non-GAAP adjusted net loss was $27.6 million, or $0.65 per share, compared to $17.3 million, or $0.78 per share, year over year.

• Research and development expenses increased to $27.6 million, primarily due to activities supporting ongoing clinical trials.

Business Progress:

• The VIKTORIA-1 Phase III clinical trial evaluating gedatolisib in breast cancer is progressing with the PIK3CA wild-type cohort fully enrolled and the mutant cohort on track.

• Plans are on track to enroll the first patient in the VIKTORIA-2 Phase III trial in Q2 2025, which evaluates gedatolisib in a first-line setting.

• Phase Ib/II trial evaluating gedatolisib in metastatic castration-resistant prostate cancer is also ongoing, with expected preliminary data in Q2 2025.

Opportunities:

• Potential market expansion with gedatolisib, targeting a peak revenue opportunity exceeding $2 billion if FDA approvals are granted for both PIK3CA wild-type and mutant populations.

• Potential to establish a new standard of care in breast cancer management with a triplet regimen including gedatolisib, addressing three interconnected signaling pathways.

• Favorable feedback on gedatolisib's IV route of administration, which could offer advantages in market access and therapy adherence.

Risks:

• Delay in reaching the primary analysis event threshold for the clinical trial cohorts could impact the timeline for drug approval and market entry.

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