Financial Data and Key Metrics Changes - The company's net loss for Q1 2025 was $37 million, or $0.86 per share, compared to a net loss of $21.6 million, or $0.64 per share for Q1 2024 [21] - Non-GAAP adjusted net loss was $34.7 million, or $0.81 per share for Q1 2025, compared to a non-GAAP adjusted net loss of $19.9 million, or $0.59 per share for Q1 2024 [21] - Research and development expenses increased to $32.2 million in Q1 2025 from $20.6 million in Q1 2024, with a significant portion attributed to clinical trial activities [21][22] Business Line Data and Key Metrics Changes - The company is focused on three clinical programs, with expectations for significant revenue generation if regulatory approvals are achieved [6][7] - The VICTORIA-one trial is designed to evaluate gadotelisib in combination with fulvestrant, targeting patients with hormone receptor positive HER2 negative advanced breast cancer [8][10] - The VICTORIA-two trial is a global phase three study evaluating gadotelisib as a first-line treatment for similar patient populations [15][17] Market Data and Key Metrics Changes - The company estimates that nearly 200,000 late-stage cancer patients globally would be eligible for treatment with gadotelisib if approved [7] - The peak revenue potential for the second-line indication could exceed $2 billion with just 40% market penetration [15] Company Strategy and Development Direction - The company aims to transition to a commercial stage company following potential FDA approvals for its clinical programs [9][10] - There is a focus on addressing the significant unmet need for effective therapies in advanced breast cancer, particularly for patients resistant to endocrine therapy [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving key clinical milestones, including data readouts from ongoing trials in 2025 [6][9] - The company recognizes the importance of demonstrating clinically meaningful results in terms of progression-free survival (PFS) to gain acceptance among oncologists [12][14] Other Important Information - The company ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments, expected to fund clinical development activities through 2026 [22][23] - The company is collaborating with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gadotelisib in endometrial cancer [19] Q&A Session Summary Question: Timing for data readout from VICTORIA-one trial - Management indicated that the primary completion date is expected in June, with data available in Q3 2025, and typically, the time from locking the database to reporting data is no more than three months [27][30] Question: Impact of SERNA6 on second-line treatment - Management believes SERNA6 will not affect their trial as it pertains to first-line CDK4/6 patients, and they expect physicians to continue treatment with gadotelisib if data is favorable [36][38] Question: Minimum hazard ratio for wild type update - Management stated that an incremental three months in PFS would be considered clinically meaningful, but they are not providing specific projections at this time [39][40] Question: Change in timing for wild type readout - Management clarified that the timing change is due to the complexity of the three-arm trial, but they are confident about the Q4 timeline for the PIK3CA mutant population [44][46] Question: Prior proof of concept data for prostate cancer - Management discussed the encouraging data for gadotelisib in prostate cancer and indicated that the update will focus on primary analysis and safety data, with further data to be reported at a medical meeting [48][52]
Celcuity(CELC) - 2025 Q1 - Earnings Call Transcript