Celcuity to Present Updated Results for Treatment-Naïve Patients from Phase 1b Study of Gedatolisib at the 2023 ESMO Breast Cancer Annual Congress

MINNEAPOLIS, MN / ACCESSWIRE / May 8, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced publication of an abstract reporting updated results for treatment-naïve patients from the Phase 1b study of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with palbociclib and letrozole in women with HR+/HER2- advanced breast cancer (ABC). A poster will be presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress, which is being held May 11-13, 2023 in Berlin, Germany.

In the poster presentation, updated efficacy and safety data in treatment-naïve patients from Escalation Arm A and Expansion Arm, with a June 29, 2022 database lock and median progression-free survival (mPFS) and duration of response (DOR) updated as of March 16, 2023, will be reported. For Expansion Arm A, median PFS was 48.6 months (n=30), and the objective response rate (ORR) was 85% (n=26, measurable and evaluable disease). When treatment naïve patients from both arms are combined, mPFS was 48.6 months (n=41) and ORR was 79% (n=33, measurable and evaluable disease).

Poster presentation details are provided below.

Title: Phase 1b study of gedatolisib plus palbociclib and endocrine therapy in women with hormone receptor positive advanced breast cancer: updated results in treatment-naïve patients
Speaker: Hope S. Rugo, MD
Session Title: Poster viewing and lunch
Date and Time: Friday, May 12, 2023, 6:15 a.m. to 7 a.m. ET (12:15 p.m. to 1 p.m. CEST)
Location: Exhibition area
Final Publication Number: 204P

The abstract is available online in advance of the 2023 ESMO Breast Cancer Annual Congress via the ESMO website. The poster will be available online on the publications page of the Celcuity website following the poster presentation.

About Gedatolisib

Gedatolisib is an investigational, pan-PI3K and mTOR inhibitor with low nanomolar potency for all Class I PI3K isoforms and mTORC1 and mTORC2. Its mechanism of action and pharmacokinetic properties are highly differentiated from other therapies that target PI3K or mTOR alone or together. Inhibiting all four Class I PI3K isoforms and mTOR limits the potential development of drug resistance compared to isoform-specific PI3K or mTOR specific inhibitors. A robust response rate and a manageable side effect profile were reported for a Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer. 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.

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, pan-PI3K and mTOR inhibitor. 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. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. 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 Celcuity.com. Follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains statements that constitute "forward-looking statements" including, but not limited to, the timing of initiating and enrolling patients in, and receiving results from, clinical trials, such as Celcuity's Phase 3 VIKTORIA-1 clinical trial, the costs and expected results from any ongoing or planned clinical trials, the impact on gedatolisib and Celcuity of preliminary clinical trial results, any potential benefits resulting from Breakthrough Therapy designation for gedatolisib, and other expectations with respect to Celcuity's lead product candidate, gedatolisib and its CELsignia platform. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, those risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 23, 2023. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.

Contacts:

Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123

ICR Westwicke
Robert Uhl, robert.uhl@westwicke.com
(619) 228-5886

SOURCE: Celcuity Inc.