Celcuity Inc. ((CELC)) has held its Q1 earnings call. Read on for the main highlights of the call.
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The recent earnings call for Celcuity Inc. highlighted a blend of optimism and caution. While the company is making strides in clinical trials and exploring lucrative market opportunities, it is also grappling with increased financial losses and a significant operational cash burn. The anticipation for upcoming data readouts is palpable, but concerns about financial sustainability loom large.
Upcoming Clinical Data Readouts
Celcuity is on track to report topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial by Q3 2025, with data from the PIK3CA mutated patient cohort expected in Q4 2025. This timeline underscores the company’s progress in its clinical trials, marking a significant milestone in their research efforts.
Potential Revenue from Gedatolisib
The company is eyeing a substantial revenue opportunity with gedatolisib. Should it receive FDA approval for both PIK3CA wild-type and mutant populations, Celcuity estimates a peak revenue potential exceeding $2 billion, assuming a 40% market penetration for the second-line indication.
Advancements in VIKTORIA-2 Trial
Celcuity has made considerable progress in the VIKTORIA-2 trial, with nearly 200 trial sites activated across various regions. This expansion reflects the company’s commitment to advancing its Phase 3 first-line trial efforts.
Endometrial Cancer Collaboration
In a strategic move, Celcuity has partnered with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole for endometrial cancer patients. This collaboration could enhance the therapeutic potential of their drug pipeline.
Increased Financial Losses
Celcuity reported a net loss of $37 million for Q1 2025, a significant increase from the $21.6 million loss in Q1 2024. This rise is primarily attributed to a notable increase in research and development expenses.
Significant Operational Cash Burn
The company’s net cash used in operating activities for Q1 2025 was $35.9 million, up from $17.1 million in Q1 2024. This increase in cash consumption highlights the financial challenges Celcuity faces as it invests heavily in its research and development initiatives.
Delay in Data Readout Timeline
The timeline for the data readout of the PIK3CA wild-type cohort has been slightly adjusted, now expected in Q3 2025. This reflects potential delays in the trial process, which could impact the company’s strategic planning.
Forward-Looking Guidance
Celcuity’s guidance for the future remains optimistic, despite financial hurdles. The company anticipates reporting topline data from the PIK3CA wild-type cohort by Q3 2025 and the mutated cohort by Q4 2025. Additionally, preliminary data from a Phase 1b prostate cancer trial is expected by the end of Q2 2025. With a projected $2 billion revenue potential for gedatolisib, Celcuity is poised for growth, provided regulatory approvals are secured. Financially, the company closed Q1 2025 with $205.7 million in cash, projecting funding through 2026.
In conclusion, Celcuity Inc.’s earnings call paints a picture of a company at a crossroads. With promising clinical developments and potential market opportunities, the future looks bright. However, the increased financial losses and operational cash burn present challenges that cannot be ignored. Investors and stakeholders will be keenly watching how Celcuity navigates these hurdles in the coming quarters.