Celcuity(CELC) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The fourth quarter net loss was $51 million or $0.97 per share, compared to a net loss of $36.7 million or $0.85 per share for the fourth quarter of 2024 [25] - The full year net loss was $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share for the same period in 2024 [25] - Non-GAAP adjusted net loss for the fourth quarter was $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share for the fourth quarter of 2024 [26] - Non-GAAP adjusted net loss for the full year was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024 [26] - Cash, cash equivalents, and short-term investments were $441.5 million at the end of fiscal year 2025, expected to finance operations through 2027 [30] Business Line Data and Key Metrics Changes - Research and development expenses for the fourth quarter were $37.6 million, up from $33.5 million for the prior year period [27] - R&D expenses for the full year were $145 million, compared to $104.2 million for the prior year [27] - General and administrative expenses for the fourth quarter were $11.6 million, compared to $3 million for the prior year period [28] - G&A expenses for the full year were $27.2 million, compared to $9.1 million for the prior year [28] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be more than $5 billion, with potential peak revenue of up to $2.5 billion annually [18] Company Strategy and Development Direction - The company is preparing for the potential approval and commercialization of gedatolisib, with a PDUFA goal date of July 17, 2026 [5] - The company aims to establish gedatolisib as a new standard of care therapy for patients with HR-positive, HER2-negative advanced breast cancer [5] - The company is engaging with payers and strategic accounts to ensure access to gedatolisib for oncologists and their patients [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's review of the NDA based on unprecedented efficacy data from the phase III VIKTORIA-1 clinical trial [6] - The company believes that the positive results from the PIK3CA wild-type cohort will position gedatolisib favorably in the market [14] - Management highlighted the importance of the safety profile of gedatolisib, which does not induce clinically relevant hypoglycemia [11][70] Other Important Information - The company has completed enrollment of the PIK3CA mutant cohort of the phase III VIKTORIA-1 trial and expects to announce results in the second quarter [7] - The company is also evaluating gedatolisib in combination with darolutamide for men with metastatic castration-resistant prostate cancer [15] Q&A Session Summary Question: Status update on the mutant data - Management could not comment on the database lock status [33] Question: Details on the disclosure of mutant data - Management indicated that top-line data will be provided in a press release, with details at a medical conference [34] Question: Feedback from physicians on launch segments - Management stated that the sales force will reach out generally to doctors to help them understand the benefits of gedatolisib [43] Question: Will physicians use it off-label for mutants? - Management confirmed that there have been no discussions with doctors about off-label use [44] Question: Details on the top-line release of median data - Management confirmed that the release will include a statement regarding the achievement of statistical significance [48] Question: Key gating factor for frontline endocrine-sensitive trial - The key gating factor is completing the safety run-in [58] Question: Challenges in getting patients for infusions - Management believes that efficacy is the most important factor for physicians and does not expect significant patient pushback on IV administration [61] Question: Commercial advantages of having a label across metastatic breast cancer subtypes - Management aims to simplify decision-making for physicians by providing a biomarker-agnostic alternative [66] Question: Learnings from the launch of inavolisib - Management noted that gedatolisib does not induce significant glycemic disruption, allowing broader patient treatment [70] Question: European commercial strategy for gedatolisib - Management plans to submit a supplemental NDA after initial approval and explore partnerships for launching in Europe [78]