Celcuity(CELC) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The fourth quarter net loss was $36.7 million or$ 0.85 per share compared to a net loss of $18.8 million or$ 0.65 per share for the fourth quarter of 2023 [41] - The full year net loss for 2024 was $111.8 million or$ 2.83 per share compared to a net loss of $63.8 million or$ 2.69 per share for the same period in 2023 [41] - Non-GAAP adjusted net loss for the fourth quarter of 2024 was $32.3 million or$ 0.75 per share compared to $17.6 million or$ 0.61 per share for the fourth quarter of 2023 [42] - Research and development expenses were $33.5 million for the fourth quarter of 2024 compared to$ 18.1 million for the fourth quarter of 2023 [42] - The company ended the year with approximately $235.1 million of cash, cash equivalents, and short-term investments, compared to$ 180.6 million on December 31, 2023 [45] Business Line Data and Key Metrics Changes - The increase in R&D expenses year-over-year was primarily due to ongoing activities supporting the Victoria 1 Phase 3 trial and the Phase 1B2 prostate trial, along with the commencement of the Victoria 2 Phase 3 trial [43] - General and administrative expenses were $3 million for the fourth quarter of 2024 compared to$ 1.6 million for the same period in 2023 [43] Market Data and Key Metrics Changes - The company estimates that approximately 15,000 to 20,000 patients with endocrine therapy-resistant advanced breast cancer are diagnosed each year in the United States alone [35] - The potential peak revenue for the second line indication could exceed $2 billion with just 40% market penetration [31] Company Strategy and Development Direction - The company anticipates 2025 to be a transformational year, expecting to report several important clinical data readouts [11] - The strategy includes the development of an optimized PAM inhibitor that targets all class I PI3K isoforms and mTORC1 and 2 to improve the standard of care in HR-positive HER2-negative advanced breast cancer [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gadotilisib to be well-tolerated and provide clinically meaningful benefits, which could favor its positioning in the treatment landscape [19] - The company is focused on optimizing the dose and schedule for the prostate cancer program, with preliminary data expected by the end of the second quarter of this year [37] Other Important Information - The company reported overall survival data from its Phase 1b study for treatment-naive and CDK4-6 pretreated patients, indicating promising results [39] - The company plans to initiate a real-time oncology review request soon after obtaining top-line data [54] Q&A Session Summary Question: Current status of the event rate for Victoria 1 - Management is not commenting on specifics related to achieving the ability to report top-line data at this stage [52] Question: Plans following the second quarter readout and NDA filing - The company hopes to initiate an RTOR request soon after top-line data is available, with expectations for priority review due to breakthrough status [54] Question: Extent of data planned to share in the 2Q top line - The company expects to present median PFS data for each of the three arms in the wild-type cohort and corresponding hazard ratios [60] Question: Feedback from investigators regarding the recent letter from Roche - Management refrained from commenting on Roche's situation but noted that PI3K alpha inhibitors require careful monitoring [62] Question: How closely to look at patient baseline characteristics in upcoming data - Management emphasized the importance of understanding patient populations and the relevance of hazard ratios for interpreting data [75] Question: Assumptions behind the$ 2 billion second line opportunity - The estimate is based on third-party data, with assumptions about patient numbers and pricing for proprietary drugs [84]