NEW YORK – Celcuity on Wednesday announced a securities purchase agreement that it estimates will bring in $50 million in gross proceeds.
According to the company, an institutional investor has agreed to buy pre-funded warrants at $8.699 per warrant and use them to purchase shares of Celcuity's common stock. Each warrant will have an exercise price of $.001 per share and will be exercisable immediately. The private placement is expected to close on Oct. 20.
Celcuity plans to use the funds to develop its PI3K and mTOR inhibitor gedatolisib, which is undergoing multiple clinical trials in breast, prostate, and gynecological cancers and other solid tumors. In the Phase III VIKTORIA-1 trial, researchers are evaluating gedatolisib plus the hormone therapy fulvestrant with and without Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) in hormone receptor-positive, HER2-negative breast cancer patients previously treated with CDK4/6 and aromatase inhibitors.
The trial will enroll approximately 700 patients with wild-type or mutant PIK3CA. Patients with wild-type PIK3CA will receive gedatolisib-Ibrance-fulvestrant, gedatolisib-fulvestrant, or just fulvestrant. Patients with a PIK3CA mutation will receive gedatolisib-Ibrance-fulvestrant, Novartis' PI3K inhibitor Piqray (alpelisib) plus fulvestrant, or gedatolisib-fulvestrant. The primary outcome measure in the trial will be progression-free survival, and secondarily, the investigators will assess overall response rate, duration of response, and other measures of efficacy.
In the Phase I/II CELC-G-201 trial, Celcuity scientists are assessing gedatolisib plus Bayer/Orion's androgen receptor inhibitor Nubeqa (darolutamide) as a treatment for metastatic castration-resistant prostate cancer (mCRPC). In the Phase I part of the trial, the researchers will evaluate two doses of gedatolisib in 18 patients and determine a recommended Phase II dose. In the Phase II portion of the trial, they will enroll an additional 12 patients at the recommended Phase II dose to evaluate progression-free survival and overall response rate.
The Minneapolis-based company licensed gedatolisib from Pfizer in 2021. As part of the deal, Celcuity entered into a $25 million debt financing agreement with Innovatus Capital Partners.
In March 2021, Celcuity raised $27.6 million in a public stock offering.
In afternoon trading on the Nasdaq, Celcuity's stock price was up around 11 percent and trading at $9.67.