PAM

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- 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 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Gedatolisib, the company’s lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTORC1/2. “We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer,” said Igor Gorbatchevsky, M.D. Chief Medical Officer of Celcuity. “A significant unmet need remains for patients with metastatic castration resistant prostate cancer who have become resistant to a next generation androgen receptor inhibitor.” “Evaluating a PAM inhibitor, such as gedatolisib, in combination with a next generation androgen receptor, has strong scientific rationale and is an important priority for mCRPC research,” said Karim Fizazi, M.D., Ph.D., Professor of Medicine at Institute Gustave Roussy and GETUG President, and one of the primary principal investigators in the study. “As it stands, there are limited options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor. Gedatolisib’s differentiated mechanism of action, and comprehensive blockade of the PAM pathway, may provide an additional treatment option for these patients.” In August 2023, Celcuity announced that it had entered into a clinical trial collaboration and supply agreement with Bayer AG to provide Nubeqa® (darolutamide) to Celcuity at no cost for the Phase 1b/2 trial. About CEL-G-201 The CELC-G-201 Phase 1b/2 clinical trial is evaluating gedatolisib plus darolutamide, an androgen receptor (AR) inhibitor, in patients previously treated with a next generation AR inhibitor for metastatic castration resistant prostate cancer (mCRPC). The study is expected to enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor. In the Phase 1b portion of the study, Celcuity expects that 36 participants will be randomly assigned to receive 600 mg darolutamide combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib. The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic progression-free survival (rPFS) at six months of patients who received the RP2D. 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. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate 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 . Follow us on LinkedIn and Twitter. Forward-Looking Statements This press release contains statements that constitute "forward-looking statements" including, but not limited to, our beliefs and expectations about the therapeutic and commercial potential of gedatolisib, the timing of initiating and enrolling patients in, and receiving results from, clinical trials, such as Celcuity's Phase 3 VIKTORIA-1 clinical trial and Phase 1b/2 CELC-G-201 clinical trial, other expectations about the size and structure of the Phase 1b/2 CELC-G-201 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, 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. View source version of release on GlobeNewswire.com Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 ICR Westwicke Maria Yonkoski, maria.yonkoski@westwicke.com (203) 682-7167

MINNEAPOLIS, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS). The preclinical studies evaluated gedatolisib, a pan-PI3K/mTOR inhibitor, and PAM inhibitors that selectively target single PAM nodes (PI3Kα, AKT, and mTORC1) to compare the functional effect of inhibiting multiple vs. single PAM pathway nodes in a panel of breast cancer cell lines. In cell viability and proliferation analyses, gedatolisib was found to be more cytotoxic and at least 300-fold more potent, on average, compared to the single node PAM inhibitors. Mechanistically, gedatolisib decreased cell survival, DNA replication, protein synthesis, glucose consumption, lactate production and oxygen consumption more effectively than the other PAM inhibitors. In vivo studies confirmed that pan-PI3K/mTOR inhibition by gedatolisib reduced tumor cell growth more effectively than single node inhibitors in breast cancer patient derived xenograft models with and without PAM pathway mutations. “These findings indicate that gedatolisib is more effective than single node PAM inhibitors at controlling key cellular functions required by cancer cells for energy production, molecule biosynthesis, and cell proliferation,” said Brian Sullivan, Celcuity’s Chief Executive Officer and co-founder. “We believe this data reinforces the relevance of gedatolisib’s highly differentiated mechanism of action.” The poster will be available in the publications page of the Celcuity website after the poster session. About Gedatolisib Gedatolisib is a potent, reversible dual inhibitor that selectively targets all Class I 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. Inhibiting all four Class I PI3K isoforms and mTOR limits the potential development of drug resistance compared with isoform-specific PI3K or mTOR specific inhibitors. A robust response rate and a manageable side effect pro reported for the Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer. 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. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is expected to be initiated 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. 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 adequacy of Celcuity’s cash on hand to fund research and development expenses and other general corporate expenses, the timing of initiating and enrolling patients in, and receiving results from, clinical trials, such as Celcuity's Phase 3 VIKTORIA-1 clinical trial and Phase 1b/2 CELC-G-201 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, as may be updated by our 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 Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 ICR Westwicke Maria Yonkoski, maria.yonkoski@westwicke.com (203) 682-7167

MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract accepted for a poster presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website. The 2023 San Antonio Breast Cancer Symposium (SABCS) is being held virtually and in-person from December 5-9, 2023. The presentation will include potency and efficacy data evaluating the effects of gedatolisib, a pan-PI3K/mTOR (PAM) inhibitor, and approved PAM inhibitors (PAMi) on breast cancer cell lines with mutated or non-mutated PAM pathway genes. Compared to the other PAMi, gedatolisib exhibited more potent and efficacious anti-proliferative and cytotoxic effects, regardless of the cell lines’ PI3K pathway mutational status. Mechanistically, gedatolisib decreased both DNA and protein synthesis more effectively than the other PAMi tested. These findings demonstrate that gedatolisib may more effectively address potential drug resistance mechanisms associated with the approved PAM inhibitors. A Phase 3 VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant with and without palbociclib is underway in in adults with HR+, HER2- advanced breast cancer. Poster presentation details are provided below. Poster Title: “Gedatolisib, a pan-PI3K inhibitor shows superior potency & efficacy relative to other PI3K/AKT/mTOR pathway inhibitors in breast cancer models”Author: Rossetti S et al.Poster ID: PO1-24-04Poster Session: Poster Session 1Presentation Time: December 6, 2023, 12:00 p.m. - 2:00 p.m. CT (1:00 p.m. - 3:00 p.m. ET) Additional data will be presented at the Poster Discussion, and the poster will be available on Celcuity's website after the poster is presented. For more details about SABCS please visit: https://www.sabcs.org/. 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. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is expected to be initiated 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. 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 efficacy and potential applications of Celcuity’s lead product candidate, gedatolisib, the timing of clinical trial activities, and other expectations with respect to 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" 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, unexpected delays or results relating to our clinical trials or regulatory approvals, and the 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, as may be updated by our 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 Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 ICR Westwicke Maria Yonkoski, maria.yonkoski@westwicke.com (203) 682-7167