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 regulatory approvals of their clinical programs, estimating that nearly 200,000 late-stage cancer patients globally would be eligible for treatment with getotelicib if approved [10] - The management highlighted the importance of favorable safety data and the potential for a significant advantage in the market due to the ease of administration of their therapies [65] Other Important Information - The company reported encouraging preliminary overall survival data from both first-line and second-line advanced breast cancer patients from their Phase 1b study [39] - The company plans to initiate a real-time oncology review request soon after obtaining top-line data [54] Q&A Session Summary Question: Update on the 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 expectations - Management hopes to initiate an RTOR request soon after top-line data and believes they would receive good consideration for priority review due to breakthrough status [54] Question: Extent of data planned to share in the 2Q top line - Management 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 their drug would allow treatment independent of metabolic status [65] Question: How closely to look at patient baseline characteristics in upcoming studies - 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 - Management provided estimates based on third-party data regarding the number of patients treated in the second line setting and pricing assumptions [84]