Breaking News

Celcuity presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR inhibitors in prostate cancer cell lines. The poster was presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium, which is being held February 16-18, 2023. The presentation titled "Therapeutic effect of gedatolisib, a pan-PI3K/mTOR inhibitor, on prostate cancer models with PI3K or PTEN mutational status" demonstrated gedatolisib's superior potency and efficacy across different prostate cancer cell lines relative to other PI3K/AKT/mTOR inhibitors of PTEN or PI3K status.

In a regulatory filing, Celcuity disclosed that its CEO Brian Sullivan bought 261K shares of common stock on December 9 in a total transaction size of $1.5M.

Celcuity announced the closing of its private placement, resulting in gross proceeds of approximately $100 million, before deducting placement agent fees and other expenses. The closing follows dosage of the first patient in Celcuity's Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib, Celcuity's lead therapeutic candidate. As a result of the closing, Celcuity will be eligible to draw on a $20 million tranche of a term loan under the terms of a $75 million debt facility, as amended in August this year. The proceeds from the private placement, combined with the debt facility and the company's current cash, cash equivalents and marketable securities, are expected to be sufficient to fund the company's current operating plan through 2025. Celcuity intends to use the net proceeds from the private placement, together with its existing cash and investments, for working capital and general corporate purposes. The private placement was led by Venrock Healthcare Capital Partners with participation from Commodore Capital, New Enterprise Associates, RA Capital Management, Soleus Capital and Brian Sullivan, the company's Chief Executive Officer and Co-Founder. Pursuant to a Securities Purchase Agreement dated May 15, 2022, investors purchased shares of the company's common stock and preferred stock at a price per share of $5.75. For each share of common stock and each 1/10 of a share of preferred stock purchased, investors received a warrant exercisable for 0.40 shares of common stock. The exercise price of the warrants is at a 40% premium to the price paid by investors for the initial shares of common stock purchased in the private placement. Subject to certain limitations such as beneficial ownership, the preferred stock and warrants are convertible into common stock at the holder's election. Jefferies LLC acted as the sole placement agent for the private placement.

Celcuity announced that updated results from a Phase 1b trial evaluating gedatolisib were presented during a Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium, or SABCS. The presentation reported updated efficacy and safety data and sub-group analysis by PIK3CA mutation status in the four expansion arms of the Phase 1b study. Additional analysis of efficacy results from patients who were treatment-naive in the advanced setting was also performed. Patients with HR+/HER2- advanced breast cancer were treated with gedatolisib combined with the CDK4/6 inhibitor, palbociclib, and endocrine therapy. This study included two dose escalation and four dose expansion arms and enrolled a total of 138 patients. Preliminary efficacy and safety results were presented in 2021. Updates presented at the 2022 SABCS included efficacy results for patient sub-groups in the four expansion arms according to their PIK3CA mutation status. Additional updates included efficacy results for the 41 patients in the study who did not receive prior therapy for advanced disease. In this combined group of treatment-naive patients from Escalation Arm A and Expansion Arm A, median PFS was 42.3 months. Treatment discontinuation due to treatment related adverse events was 6.5% in Arm A, 15.4% in Arm B, 9.4% in Arm C and 3.7% in Arm D. Further details on baseline patient characteristics were also included.

Celcuity announced that updated results from a Phase 1b trial evaluating gedatolisib were presented during a Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium. The presentation reported updated efficacy and safety data and sub-group analysis by PIK3CA mutation status in the four expansion arms of the Phase 1b study. Additional analysis of efficacy results from patients who were treatment-naive in the advanced setting was also performed. "The comparable efficacy reported in patients with and without PIK3CA mutations is very encouraging. We believe these results reflect gedatolisib's unique mechanism of action," said Brian Sullivan, Celcuity's CEO and co-founder. "We are also very encouraged by the median PFS of 42.3 months reported for patients with advanced disease who were treatment naive. These results compare favorably to published data for current standard-of-care regimens for patients with advanced disease who are treatment naive. The results warrant further evaluation of gedatolisib in combination with a CDK4/6 inhibitor and endocrine therapy in early line settings, including first-line, neoadjuvant, or adjuvant indications." Patients with HR+/HER2- advanced breast cancer were treated with gedatolisib combined with the CDK4/6 inhibitor, palbociclib, and endocrine therapy. This study included two dose escalation and four dose expansion arms and enrolled a total of 138 patients. Preliminary efficacy and safety results were presented in 2021. Updates presented at the 2022 SABCS included efficacy results for patient sub-groups in the four expansion arms according to their PIK3CA mutation status. Additional updates included efficacy results for the 41 patients in the study who did not receive prior therapy for advanced disease. In this combined group of treatment-naive patients from Escalation Arm A and Expansion Arm A, median PFS was 42.3 months. Treatment discontinuation due to treatment related adverse events was 6.5% in Arm A, 15.4% in Arm B, 9.4% in Arm C and 3.7% in Arm D. Further details on baseline patient characteristics were also included.