Celcuity Inc. ((CELC)) has held its Q4 earnings call. Read on for the main highlights of the call.
Celcuity Inc.’s recent earnings call painted a picture of a company making significant strides in its clinical development programs while grappling with increased net losses and expenses. Despite these financial challenges, the promising clinical data and potential for blockbuster revenue suggest a positive outlook for the company.
Progress in Clinical Development Programs
Celcuity has made notable progress in its clinical development programs, completing the enrollment of the PIK3CA wild-type cohort in the VIKTORIA-1 Phase III study and selecting approximately 200 sites for the VIKTORIA-2 Phase III study. Additionally, the Phase Ib dose escalation study for prostate cancer is ongoing and expected to yield preliminary data by mid-2025.
Potential Blockbuster Revenue
The company estimates that nearly 200,000 late-stage cancer patients globally could be eligible for treatment with gedatolisib. If regulatory approvals are obtained, this could potentially generate blockbuster revenue, marking a significant milestone for Celcuity.
Encouraging Overall Survival Data
Preliminary data from the Phase Ib study revealed promising overall survival results, with a median survival of 77 months for first-line patients and 34 months for second-line patients, which compares favorably to existing published data.
Strong Financial Position
Celcuity concluded fiscal 2024 with a robust financial position, holding $235.1 million in cash, cash equivalents, and short-term investments. This marks an increase of $54.5 million from the previous year, underscoring the company’s strong financial footing.
Increased Net Loss
The company reported a net loss of $36.7 million for Q4 2024, a significant increase from $18.8 million in Q4 2023. For the entire year, the net loss was $111.8 million, compared to $63.8 million in 2023, highlighting the financial challenges faced by Celcuity.
Higher R&D and Administrative Expenses
Research and development expenses surged to $33.5 million in Q4 2024, up from $18.1 million in the same quarter of the previous year. General and administrative expenses also rose to $3 million from $1.6 million, reflecting the company’s ongoing investment in its clinical trials.
Forward-Looking Guidance
During the earnings call, Celcuity provided forward-looking guidance, reporting a net loss of $36.7 million, or $0.85 per share, for the fourth quarter. For the full year 2024, the net loss totaled $111.8 million, or $2.83 per share. The company ended the year with $235.1 million in cash and equivalents, bolstered by financing activities that raised $138.4 million.
In summary, Celcuity Inc.’s earnings call highlighted a company at the forefront of clinical development with a promising outlook for future revenue, despite current financial challenges. The overall sentiment was positive, driven by strong clinical data and a robust financial position, setting the stage for potential growth in the coming years.