Celcuity Launches Phase 3 Trial for Advanced Breast Cancer

Celcuity Inc. (NASDAQ: CELC) has announced its plan to commence a phase 3 clinical trial to evaluate gedatolisib, in combination with a cdk4/6 inhibitor and fulvestrant, as a first-line treatment for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer who are resistant to endocrine therapy. The company has also secured approximately $62 million in debt financing, affirming its commitment to advancing targeted therapies for oncology.

In the phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, the median progression-free survival was reported at 48.6 months, with an overall response rate of 79%. These promising results have underscored the potential benefits of inhibiting the PI3K/AKT/mTOR pathway in treatment-naïve patients.

The new phase 3 clinical trial, named Viktoria-2, will enroll approximately 638 subjects across North America, Europe, Latin America, and Asia. The primary endpoints of the trial will be the progression-free survival (PFS) as assessed by blinded independent central review. The trial is expected to mark its first patient enrollment in the second quarter of 2025.

In addition to the clinical trial initiation, Celcuity has also amended its existing debt financing agreement and secured an additional term loan of approximately $62 million, increasing the total debt financing to $180 million. The funding will enable Celcuity to accelerate the initiation of the phase 3 study and provide further support for its research and development efforts.

Celcuity's CEO and co-founder, Brian Sullivan, expressed excitement about the additional capital secured, emphasizing the importance of allowing investigators to choose between ribociclib or palbociclib as the cdk4/6 inhibitor for their patients and the randomization of patients based on their PIK3CA mutation status. The company has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the trial design.

The debt financing agreement was amended with an affiliate of Innovatus Capital Partners, LLC, and Oxford Finance LLC. Under the amended agreement, Celcuity will receive $61.7 million, bringing the total outstanding debt to $100 million. The company may draw an additional tranche of $30 million and $50 million upon achieving certain clinical trial and regulatory milestones.

Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. Its lead therapeutic candidate, gedatolisib, is a potent, pan-PI3K and mTOR inhibitor. The company is currently enrolling patients in the phase 3 clinical trial Viktoria-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2* advanced breast cancer. Furthermore, Celcuity is also conducting a phase 1b/2 clinical trial, Celc-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer. Today the company's shares have moved 6.5% to a price of $15.81. For the full picture, make sure to review Celcuity's 8-K report.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.