Celcuity to Host Virtual Science Day for Investors Event to be webcast from 10:00 a.m. – 12:00 p.m. ET on September 21, 2023
MINNEAPOLIS, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will host a Virtual Science Day for analysts and investors from 10:00 a.m. – 12:00 p.m. ET on Thursday, September 21, 2023. During this informative event, Celcuity will provide an in-depth overview of its lead compound, the equipotent pan-PI3K/mTOR inhibitor gedatolisib, discuss the importance of comprehensive, rather than selective, inhibition of the PI3K/mTOR pathway, and review its anticipated clinical development strategy in breast and prostate cancerbreast and prostate cancer. “We look forward to providing additional insights about gedatolisib’s highly differentiated mechanism of action and how, we believe, this MOA can enable gedatolisib to potentially obtain several blockbuster indications,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. Key opinion leaders speaking at Celcuity’s Virtual Science Day will include two leading oncologists: Karim Fizazi, M.D., Ph.D., Professor of Oncology at the University of Paris-Saclay, and former head of the department of oncology medicine at Gustav Roussy specializing in the treatment of prostate cancer. Celcuity’s Virtual Science Day for analysts and investors will take place on Thursday, September 21, 2023, from 10:00 a.m. to 12:00 p.m. ET. To register for the event, please click here. A replay of the webcast will be available on the “Events & Presentations” section of Celcuity’s website following the event. About the Phase 1b/2 CELC-G-201 Trial
Gedatolisib is a potent inhibitor that selectively targets all Class I isoforms of PI3K 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. Inhibiting all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitorsPI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the absence of mTOR inhibition. Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for oncology. 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 cancerHR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is planned to begin enrolling patients in the first quarter of 2024. 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 and Phase 1b/2 CELC-G-201 clinical trial, the costs and expected results from ongoing and planned clinical trials, the impact on gedatolisib and Celcuity of preliminary clinical trial results, the market opportunity for gedatolisib in the prostate and breast cancer markets, and other expectations with respect to Celcuity's lead product candidate, gedatolisib, and Celcuity’s 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," “goal,” 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, delays, disruptions or adverse results in our clinical trials and 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, and our subsequent Quarterly Reports on Form 10-Q. 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. View source version of release on GlobeNewswire.com
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
Robert Uhl, robert.uhl@westwicke.com