Celcuity Inc. has recently released its 10-Q report, providing a detailed insight into its financial performance and operational activities. The company, a clinical stage biotechnology firm based in the United States, is focused on developing targeted therapies for various solid tumors. Celcuity's proprietary CELsignia diagnostic platform utilizes a patient's living tumor cells to identify the specific abnormal cellular process driving cancer and the related targeted therapy for treatment. The company's lead therapeutic candidate is gedatolisib, a pan-PI3K/mTOR inhibitor, with a focus on treating hormone receptor positive, HER2-negative, advanced or metastatic breast cancer, and metastatic castration-resistant prostate cancer.
In the 10-Q report, Celcuity highlighted its ongoing Phase 3 study, VIKTORIA-1, which is evaluating gedatolisib and fulvestrant with and without Ibrance (palbociclib) as a second-line treatment for patients with HR+, HER2 advanced breast cancer. The company also began enrolling patients in CELC-G-201, a Phase 1b/2 study evaluating gedatolisib combined with Nubeqa (darolutamide) in patients with metastatic castration-resistant prostate cancer. Additionally, plans to initiate VIKTORIA-2, a Phase 3 trial evaluating gedatolisib combined with fulvestrant plus a CDK 4/6 inhibitor as first-line treatment for patients with HR+, HER2 advanced breast cancer were announced. The report also mentioned that Celcuity's CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.
Gedatolisib, Celcuity's drug candidate, is a potent, well-tolerated, reversible, ATP-competitive, pan-PI3K/mTOR inhibitor that selectively targets all Class I isoforms of PI3K and mTOR complexes. As of September 30, 2024, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials, with promising results in terms of overall response rates and progression-free survival in patients with HR+/HER2* metastatic breast cancer. The company also received FDA approval to proceed with the clinical development of gedatolisib in combination with Nubeqa for the treatment of patients with metastatic castration-resistant prostate cancer.
The Phase 3 VIKTORIA-2 clinical trial, which aims to evaluate the efficacy and safety of gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor in comparison to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+/HER2* advanced breast cancer, is on track to enroll its first patient in Q2 2025. The company is actively working on these clinical trials, and the enrollment in VIKTORIA-1 study remains robust and on-track. Based on the current forecast, Celcuity expects to report topline data for the PIK3CA WT cohort sometime in late Q1 2025 or during Q2 2025 and to report topline data for the PIK3CA MT cohort in the second half of 2025. Following these announcements, the company's shares moved -14.7%, and are now trading at a price of $12.04. If you want to know more, read the company's complete 10-Q report here.
