The company specializes in the development of targeted therapies for solid tumor indications and is headquartered in Minneapolis. While the stock has declined about 13% year-to-date, InvestingPro analysis indicates that Celcuity (NASDAQ:CELC) maintains a strong liquidity position with a current ratio of 10.36 and more cash than debt on its balance sheet. More information on Celcuity and its clinical trials can be found on their website. Get deeper insights into Celcuity's financial health and growth prospects with InvestingPro, which offers exclusive access to detailed financial analysis and 8 additional ProTips for informed investment decisions.
The trial evaluated gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant. The OS data from two patient cohorts are seen as encouraging when compared to existing first- or second-line standard-of-care regimens for this type of advanced breast cancer.
Igor Gorbatchevsky, MD, Chief Medical (TASE:PMCN) Officer of Celcuity, commented on the results, highlighting the clinical development strategy of blocking multiple signaling pathways with the combination therapy. The company's ongoing VIKTORIA-1 and planned VIKTORIA-2 Phase 3 clinical trials are based on this strategy, aiming to evaluate the treatment in second- and first-line settings, respectively.
Gedatolisib has been granted U.S. Food and Drug Administration Breakthrough Therapy designation for treating HR+/HER2- advanced breast cancer that has progressed following treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.
Celcuity is also conducting a Phase 1b/2 trial, CELC-G-201, for gedatolisib in metastatic castration-resistant prostate cancer and expects to begin enrolling patients in the VIKTORIA-2 trial in the second quarter of 2025.
The company specializes in the development of targeted therapies for solid tumor indications and is headquartered in Minneapolis. While the stock has declined about 13% year-to-date, InvestingPro analysis indicates that Celcuity maintains a strong liquidity position with a current ratio of 10.36 and more cash than debt on its balance sheet. More information on Celcuity and its clinical trials can be found on their website. Get deeper insights into Celcuity's financial health and growth prospects with InvestingPro, which offers exclusive access to detailed financial analysis and 8 additional ProTips for informed investment decisions.
This news article is based on a press release statement from Celcuity Inc. and does not include any additional sources or independent verification. The information presented is a direct representation of the company's reported data and statements.
In other recent news, Celcuity Inc. disclosed its third-quarter 2024 financial results, recording a net loss of $29.8 million. The loss was larger than the same quarter last year, but the per-share impact was lower due to an increased share count. The company's research and development expenses escalated, primarily attributed to the progression of clinical trials for gedatolisib. Despite the net loss, Celcuity maintained a solid cash position of $264.1 million, thanks to successful financing activities.
The company also provided updates on its clinical trials, particularly highlighting the development of gedatolisib. The drug has shown a favorable safety profile and administration method, raising optimism about its market potential. If the trials yield positive results, Celcuity plans to file a new drug application.
Analysts noted that Celcuity's R&D expenses rose to $27.6 million, driven by the VIKTORIA-1 and VIKTORIA-2 trials for gedatolisib. The company announced upcoming presentations at the San Antonio Breast Cancer Symposium and investor conferences, where it plans to present overall survival data from the Phase Ib trial of gedatolisib. Despite the increased net loss and R&D expenses, Celcuity maintains a positive outlook, hoping for gedatolisib to become a new standard of care for HR-positive, HER2-negative advanced breast cancer.
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