The following is a summary of the Celcuity Inc. (CELC) Q1 2024 Earnings Call Transcript:

Financial Performance:

• Celcuity reported a Q1 2024 net loss of $21.6 million, an increase from its Q1 2023 net loss of $11.9 million.

• The per share net loss is reported at $0.64 compared to $0.55 per share in Q1 2023.

• Non-GAAP net loss for Q1 2024 was $19.9 million or $0.59 per share as compared to $11.9 million or $0.55 per share in Q1 2023.

• Research and development expenses increased to $20.7 million, a significant rise from $11.3 million in Q1 2023.

• The company maintains a wealth of $177.7 million in cash, cash equivalents, and short-term investments.

Business Progress:

• Progress on the Phase 3 VIKTORIA-1 trial remains steady, with Celcuity accomplishing over 50% patient enrollment.

• Celcuity kickstarted a Phase 1b/2 trial, focusing on gedatolisib and darolutamide efficacy in patients with metastatic castration-resistant prostate cancer. The preliminary data is expected in H1 2025.

• The company maintains its H2 2024 topline guidance and plans for a commercial launch are underway.

• The product development strategy is based on the ESMO guidelines aimed at patient populations with endocrine resistance.

• Clinical trial quality control will be maintained through adequate stratification of study arms.

• The plan of including patients with diverse durations on preceding endocrine therapies is set.

• Full data for the wild type cohort is scheduled for disclosure in December 2024, during the San Antonio Breast Cancer meeting.

More details: Celcuity IR

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