Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer

First patient dosing enables closing of $100 million PIPE financing and drawdown of $20 million term loan tranche

MINNEAPOLIS, MN / ACCESSWIRE / December 7, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib plus fulvestrant with and without palbociclib for the treatment of patients with HR+/HER2- advanced breast cancer. Gedatolisib, the company's lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR.

"We are excited to begin enrolling patients in the VIKTORIA-1 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with breast cancer," said Igor Gorbatchevsky, M.D. Chief Medical Officer of Celcuity. "We look forward to generating robust data with the goal of supporting a future regulatory submission."

"Patients with HR+/HER2- advanced breast cancer whose disease progressed while on treatment with a CDK4/6 inhibitor need better therapeutic options. VIKTORIA-1 is an important and innovative study that has the potential to provide two different treatment regimens for these patients," said Sara Hurvitz, M.D., Professor at the David Geffen School of Medicine at UCLA and a co-principal investigator for the clinical trial.

In July 2022, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to gedatolisib for the treatment of HR+/HER2- advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met. Gedatolisib previously received Fast Track designation from the FDA in January 2022.

Dosing the first patient satisfies the primary closing condition of a $100 million private placement agreement that the company signed in May of this year. Investors participating in the private placement include Venrock Healthcare Capital Partners, Commodore Capital, New Enterprise Associates (NEA), RA Capital Management, Soleus Capital, and Brian Sullivan, the Company's Chief Executive Officer and Co-Founder. Under the terms of the private placement, investors will purchase common stock, preferred stock that may be convertible into common stock, and warrants exercisable for common stock.