8-K: Celcuity Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update

Celcuity Inc. announced its first quarter 2025 financial results, highlighting progress in clinical trials and a collaboration with Dana Farber Cancer Institute and Massachusetts General Hospital.

Summary

• Celcuity Inc. reported its financial results for the first quarter ended March 31, 2025.
• The company is making progress across its pipeline, with several critical data catalysts anticipated this year.
• Topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 trial is expected in the third quarter of 2025, and for the PIK3CA mutant cohort in the fourth quarter of 2025.
• If the topline data from the WT cohort is positive, the company expects to file its first new drug application.
• The VIKTORIA-2 Phase 3 trial remains on track to dose its first patient in the second quarter of 2025.
• A clinical trial collaboration has been initiated with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.
• Total operating expenses for the first quarter of 2025 were $36.1 million, compared to $22.5 million for the first quarter of 2024.
• Research and development expenses were $32.2 million, compared to $20.6 million in the prior-year period.
• General and administrative expenses were $3.9 million, compared to $1.8 million in the prior-year period.
• Net loss for the first quarter of 2025 was $37.0 million, or $0.86 loss per share, compared to a net loss of $21.6 million, or $0.64 loss per share, for the first quarter of 2024.
• Non-GAAP adjusted net loss for the first quarter of 2025 was $34.7 million, or $0.81 loss per share, compared to $19.9 million, or $0.59 loss per share, for the first quarter of 2024.
• At March 31, 2025, Celcuity reported cash, cash equivalents, and investments of $205.7 million.
• The company expects its cash, cash equivalents, investments, and drawdowns on its debt facility to fund current clinical development program activities through 2026.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company reported increased losses, it also highlighted progress in its clinical trials and has a strong cash position. The collaboration with Dana Farber and Massachusetts General Hospital is a positive development.

Positives

• Celcuity has a strong cash position of approximately $206 million as of March 31, 2025, which is expected to fund operations through 2026.
• The company is progressing with its clinical trials, with topline data readouts expected for the VIKTORIA-1 trial in Q3 and Q4 2025.
• A new clinical trial collaboration with Dana Farber Cancer Institute and Massachusetts General Hospital expands the evaluation of gedatolisib to endometrial cancer.
• The VIKTORIA-2 Phase 3 trial is on track to dose its first patient in the second quarter of 2025.

Negatives

• The net loss increased to $37.0 million, or $0.86 per share, for Q1 2025, compared to a net loss of $21.6 million, or $0.64 per share, for Q1 2024.
• Total operating expenses increased significantly to $36.1 million in Q1 2025 from $22.5 million in Q1 2024.

Risks

• The company's future success depends on the outcome of its clinical trials, which are subject to unforeseen delays and uncertainties.
• The company's ability to obtain regulatory approvals and commercialize its products is not guaranteed.
• The company faces competition from other therapies and tools in the market.
• The company's ability to access capital upon favorable terms or at all is subject to market conditions and other factors.

Future Outlook

Celcuity expects its current cash, cash equivalents, investments, and drawdowns on its debt facility to fund its clinical development program activities through 2026. The company anticipates topline data readouts from the VIKTORIA-1 trial in Q3 and Q4 2025 and is preparing for a potential new drug application filing if the data is positive.

Management Comments

• We continue to make steady progress across our pipeline with several critical data catalysts anticipated this year, said Brian Sullivan, CEO and co-founder of Celcuity.
• If our topline data from the WT cohort is positive, we expect the data will support the filing of our first new drug application and, if approved, our transition to a commercial stage company.

Industry Context

Celcuity is focused on developing targeted therapies for solid tumor indications, specifically using gedatolisib, a PI3K/AKT/mTOR inhibitor. This approach aligns with the broader industry trend of developing personalized medicine and targeted therapies for cancer. The collaborations with Dana Farber and Massachusetts General Hospital are indicative of the industry's emphasis on partnerships to accelerate drug development.

Comparison to Industry Standards

• Celcuity's focus on PI3K/AKT/mTOR inhibition places it among companies like Novartis (with PI3K inhibitor Piqray) and Roche (with AKT inhibitor ipatasertib), which are also targeting this pathway in cancer.
• The VIKTORIA trials are comparable to other Phase 3 trials in HR+/HER2breast cancer, such as the MONALEESA trials (Novartis' ribociclib) and the PALOMA trials (Pfizer's palbociclib), which have established CDK4/6 inhibitors as a standard of care.
• The reported cash runway through 2026 is a positive sign, as many biotech companies face challenges in securing funding for their clinical programs; this runway provides Celcuity with financial stability to execute its strategy.

Stakeholder Impact

• Shareholders: The increased net loss may negatively impact shareholder value in the short term, but progress in clinical trials and a strong cash position could provide long-term benefits.
• Employees: The company's ability to fund operations through 2026 provides job security for employees.
• Patients: Successful clinical trials could lead to new treatment options for patients with breast cancer, endometrial cancer, and prostate cancer.
• Clinical Trial Sites: The company's ongoing and planned clinical trials will provide revenue for clinical trial sites.

Next Steps

• Report topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 trial in the third quarter of 2025.
• Report topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial in the fourth quarter of 2025.
• Dose the first patient in the VIKTORIA-2 Phase 3 trial in the second quarter of 2025.
• Report topline data for the Phase 1b portion of the CELC-G-201 trial late in the second quarter of 2025.
• Continue the clinical trial collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.

Key Dates

Keywords

Celcuity, gedatolisib, VIKTORIA-1, VIKTORIA-2, clinical trials, breast cancer, endometrial cancer, prostate cancer, financial results, R&D expenses, operating expenses, net loss