Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer - Seite 2

Upon the closing of the $100 million private placement and subject to other customary conditions, Celcuity will also 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. Additional details regarding the private placement and this debt facility, including the full text of the securities purchase agreement for the private placement and the August amendment of the debt facility, are available with the Company's Current Reports on Form 8-K filed with the Securities and Exchange Commission on May 18, 2022 and August 11, 2022, respectively.

"Closing the private placement and drawing down the additional tranche of our term loan will be important milestones for Celcuity. These financings significantly will strengthen our balance sheet and are expected to provide the capital we need to fund operations through 2025," said Brian Sullivan, CEO and co-founder of Celcuity.

About VIKTORIA-1

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial will enroll subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). Up to 351 subjects who are PIK3CA WT will be enrolled. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) will be randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant (Arm E), or gedatolisib plus fulvestrant (Arm F). Up to 350 subjects who are PIK3CA MT will be enrolled.

About Celcuity

Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer, is currently enrolling patients. The company's CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter.