Celcuity(US:CELC)2025-11-12 22:30Financial Data and Key Metrics Changes - The company's net loss for Q3 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $29.8 million, or $0.70 per share for Q3 2024 [19] - Non-GAAP adjusted net loss was $37.2 million, or $0.78 per share for Q3 2025, compared to a non-GAAP adjusted net loss of $27.6 million, or $0.65 per share for Q3 2024 [19] - Research and development expenses increased to $34.9 million for Q3 2025 from $27.6 million in Q3 2024, with a significant portion attributed to increased employee and consulting expenses [19][20] - General and administrative expenses rose to $7.9 million for Q3 2025 from $2.5 million in Q3 2024, primarily due to increased employee and consulting expenses [20] Business Line Data and Key Metrics Changes - The company achieved significant clinical and regulatory milestones, including the release of positive data from the PIK3CA wild-type cohort of the phase III VIKTORIA-1 study [4][5] - The median progression-free survival (PFS) for the gedatolisib triplet was reported at 9.3 months, compared to 2 months for fulvestrant, indicating a 7.3-month improvement [7] - The objective response rate for the gedatolisib triplet was 32%, with a median duration of response of 17.5 months, while the doublet showed an objective response rate of 28% and a median duration of response of 12.0 months [9][10] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be between $5 billion and $6 billion, with potential peak revenues of $2.5 billion to $3 billion [17][18] - The company estimates there are approximately 37,000 patients in the U.S. with HR positive, HER2 negative, advanced breast cancer who have progressed after treatment with a CDK4/6 inhibitor [17] Company Strategy and Development Direction - The company is preparing for a potential launch of gedatolisib, having ramped up efforts following the positive data release [15] - The strategic launch plan includes building the organization and internal systems required to operate as a commercial stage company [15] - The company aims to establish gedatolisib as the new standard of care in the second-line setting for HR positive, HER2 negative, advanced breast cancer [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gedatolisib to address critical needs in the second-line space, highlighting its unique mechanism of action and favorable safety and efficacy profile [18] - The company expects to complete the NDA submission for gedatolisib by the end of Q4 2025 [26] - Management noted that the positive interim overall survival data could support the drug's approval process [38] Other Important Information - The company completed concurrent offerings resulting in net proceeds of approximately $287 million, which will support commercial launch preparations and other strategic initiatives [21][22] - The company ended the quarter with approximately $455 million in cash, cash equivalents, and short-term investments [20] Q&A Session Summary Question: Plans for additional data at the San Antonio Breast Cancer Symposium - The company plans to present additional subgroup analyses and efficacy data at the conference [24] Question: Impact of second-line data on enrollment in VIKTORIA II - Enrollment is on track, and investigators are excited about the results, which may positively impact visibility and credibility [24] Question: Real-time oncology review submission process - The submission for the wild-type cohort will be separate from the mutant submission, with potential for a real-time oncology review for the mutant data depending on the results [25][27] Question: Duration of therapy and pricing strategy - The company is analyzing the duration of therapy and pricing strategy, with benchmarks around $25,000 for similar therapeutics [28][29] Question: Plans for commercialization outside the U.S. - The company plans to find partners for commercialization outside the U.S. and is preparing for regulatory submissions in Europe and Japan [31] Question: Overall survival trends and regulatory implications - The interim overall survival analysis showed a favorable trend, which could support the drug's approval process [38]