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MINNEAPOLIS - Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotech company with a market capitalization of $475 million, announced preliminary clinical data showing promising results for its cancer drug gedatolisib in two early-phase trials, according to a company press release. The company’s stock has shown strong momentum, gaining over 9% in the past week. According to InvestingPro, there are 12 additional key insights available about Celcuity’s performance and prospects.
In a Phase 1 trial evaluating gedatolisib plus darolutamide in men with metastatic castration-resistant prostate cancer (mCRPC), the six-month radiographic progression-free survival rate was 66%. The trial involved 38 patients who received darolutamide combined with different doses of gedatolisib. While developing these promising treatments, InvestingPro data shows Celcuity maintains a strong liquidity position with a current ratio of 6.6, though the company is experiencing rapid cash burn as typical for clinical-stage biotechs.
No patients discontinued treatment due to treatment-related adverse events, and no dose reductions were required with either medication. Grade 2-3 stomatitis was reported in four patients (10.5%), with only one case (2.6%) classified as Grade 3.
In a separate Phase 2 trial, gedatolisib combined with trastuzumab-pkrb showed a 43% objective response rate in patients with HER2-positive metastatic breast cancer who had received multiple prior treatments. The median progression-free survival was 6.0 months, and median overall survival reached 24.7 months.
The breast cancer trial enrolled 44 patients, with 86% having received at least three prior anti-HER2 therapies. Similar to the prostate cancer trial, no patients discontinued gedatolisib due to treatment-related adverse events.
"The 66% six-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting," said Igor Gorbatchevsky, Chief Medical Officer of Celcuity, according to the release.
Based on these preliminary results, Celcuity has amended the prostate cancer trial protocol to explore additional dose options before determining the recommended Phase 2 dose.
Gedatolisib is described as a multi-target inhibitor that blocks all four class I PI3K isoforms and the mTOR complexes to inhibit the PI3K/AKT/mTOR pathway, which plays a key role in cancer cell growth and survival.
In other recent news, Celcuity LLC reported a larger-than-expected loss for the first quarter of 2025. The company announced earnings per share (EPS) of -$0.86, which fell short of the forecasted -$0.72. Despite the earnings miss, Celcuity’s stock remained stable in aftermarket trading. The company emphasized its strong cash reserves of $205.7 million, which are projected to support operations through 2026. Celcuity is heavily investing in research and development, with expenses rising significantly from $20.6 million to $32.2 million year-over-year. The company’s ongoing clinical trials, including those for prostate cancer and advanced breast cancer, are expected to yield top-line data later in 2025. Analysts from Jefferies and Leerink have shown interest in the company’s data readouts and potential market impact. Celcuity’s CEO, Brian Sullivan, expressed confidence in the company’s clinical programs and financial stability.
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