The following is a summary of the Celcuity Inc. (CELC) Q2 2024 Earnings Call Transcript:

Financial Performance:

• For Q2 2024, Celcuity reported a net loss of $23.7 million or $0.62 per share, compared from a net loss of $14.6 million or $0.66 per share in Q2 2023.

• Non-GAAP adjusted net loss was $22.2 million or $0.58 per share for Q2 2024, compared to a non-GAAP adjusted net loss of $11.1 million or $0.51 per share in Q2 2023.

• The company raised $129 million from equity and debt offerings to strengthen their balance sheet.

Business Progress:

• Celcuity has advanced the clinical development of gedatolisib with ongoing enrollment in key trials such as VIKTORIA-1 for advanced breast cancer and a trial for metastatic castration resistant prostate cancer.

• Plans are in place for launching VIKTORIA-2 to evaluate gedatolisib as a first-line treatment for patients with HR+/HER2- advanced breast cancer.

• Non-clinical research on gedatolisib was published, demonstrating its efficacy compared to single-node PI3K inhibitors in various cancer models.

Opportunities:

• Celcuity expects to enroll about 638 subjects in the VIKTORIA-2 study, aimed at addressing the significant market of endocrine therapy resistant advanced breast cancer patients estimated at 15,000 to 20,000 annually in the US alone, potentially increasing the addressable market size for gedatolisib by up to $3 billion.

Risks:

• Projected shifts in the proportion of PIK3CA wild-type versus mutated patients in ongoing trials might impact the timing and outcomes of primary analysis events anticipated in late Q4 2024 to Q1 2025.

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