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 [20] - 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 [20] - Research and development expenses increased to $32.2 million for Q1 2025 from $20.6 million in Q1 2024, with a significant portion attributed to clinical trial activities [20][21] - General and administrative expenses rose to $3.9 million for Q1 2025 from $1.8 million in Q1 2024 [21] - Net cash used in operating activities was $35.9 million for Q1 2025, compared to $17.1 million for Q1 2024 [22] - The company ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments [22] Business Line Data and Key Metrics Changes - The company is focused on three clinical programs, with significant revenue potential if regulatory approvals are obtained [7][8] - The Phase III VICTORIA-one trial is designed to evaluate gadotelisib in combination with fulvestrant for advanced breast cancer patients [9] - The VICTORIA-two trial is a global Phase III study evaluating gadotelisib as a first-line treatment for HR positive, HER2 negative advanced breast cancer [15][16] - The Phase 1B2 trial is assessing gadotelisib in combination with darolutamide for metastatic castration-resistant prostate cancer [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 [8] - The peak revenue potential for the second-line indication of gadotelisib 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 [10] - The focus is on developing effective therapies for advanced breast cancer patients resistant to endocrine therapy, addressing a significant unmet need in the market [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical data readouts, with top-line data expected from the VICTORIA-one trial in Q3 2025 [7][10] - The company recognizes the importance of demonstrating clinically meaningful results in terms of progression-free survival (PFS) to gain market acceptance [12][14] Other Important Information - The company is collaborating with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gadotelisib in endometrial cancer [18] - The company expects its current cash reserves to fund clinical development activities through 2026 [22] Q&A Session Summary Question: Timing for VICTORIA-one data readout - Management expects to lock the database in June and report results in Q3 2025, with no anticipated delays [27][28][30] Question: Impact of SERNA6 on second-line setting - Management believes SERNA6 will not affect their patient population as it pertains to first-line CDK4/6 patients [36][37] Question: Minimum HR for wild type update - Management indicated that an incremental three months in PFS would be considered clinically meaningful, but specifics will not be disclosed until data is available [39][40] Question: Change in timing for wild type readout - Management clarified that variability in event distribution among trial arms influenced the timing, but they remain confident in the Q4 timeline for the PIK3CA mutant population [43][44] Question: Prior proof of concept data for prostate cancer - Management discussed the encouraging non-clinical data supporting the efficacy of gadotelisib compared to single-node inhibitors [47][49]