Celcuity Inc Stock Price, News & Analysis

Celcuity Inc. (Nasdaq:CELC) recently presented preclinical studies on gedatolisib, a pan-PI3K and mTOR inhibitor, showcasing its enhanced anti-tumor efficacy in gynecological cancer models, including endometrial, ovarian, and cervical cancers. The data, revealed at the 2023 AACR Annual Meeting, indicate gedatolisib outperformed other PAM inhibitors irrespective of mutational status, demonstrating significant tumor growth inhibition in vivo. The findings suggest gedatolisib's potential across various solid tumors, reinforcing its differentiated mechanism of action. Currently, a Phase 3 trial, VIKTORIA-1, is ongoing to further evaluate gedatolisib's effectiveness in treating HR+/HER2- advanced breast cancer. These developments highlight the investigational drug's promising profile and potential market impact in oncology.

Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, will participate in the 22nd Annual Needham Virtual Healthcare Conference on April 19, 2023. Brian Sullivan, the company's CEO, is scheduled to present at 1:30 p.m. ET. The presentation can be accessed via a live webcast linked here or through the company's Investors section, where a replay will also be available afterwards.

Celcuity's lead candidate, gedatolisib, is designed to target multiple solid tumors and is currently in a Phase 3 trial (VIKTORIA-1) for HR+/HER2- advanced breast cancer. The company's CELsignia platform analyzes live patient tumor cells to identify cancer patients who may benefit from existing therapies. For more information, visit Celcuity.com.

Celcuity, a clinical-stage biotechnology company, announced significant milestones, including dosing the first patient in the Phase 3 VIKTORIA-1 trial for gedatolisib, leading to a $100 million PIPE financing and a $20 million term loan. These funds extend cash runway into 2025. The company reported a net loss of $11.6 million for Q4 2022, increasing from $6.8 million in Q4 2021, with full-year losses of $40.4 million. Total operating expenses for Q4 were $11.6 million, up from $6.3 million the previous year. However, cash reserves at year-end stood at $168.6 million, ensuring operational stability for upcoming trials.

Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, will announce its fourth quarter and full year 2022 financial results on March 23, 2023, after market close. A webcast and teleconference will follow at 4:30 p.m. Eastern Time for discussion. The company is focused on developing targeted therapies for oncology, with its leading candidate, gedatolisib, currently in a Phase 3 clinical trial for HR+/HER2- advanced breast cancer. The VIKTORIA-1 trial is enrolling patients and represents a key development for Celcuity. More details can be found on ClinicalTrials.gov.

Celcuity Inc. (NASDAQ: CELC) announced the publication of preclinical data on gedatolisib, a pan-PI3K/mTOR inhibitor, demonstrating significant therapeutic effects against endometrial, ovarian, and cervical cancer cell lines. This data will be presented at the 2023 AACR Annual Meeting on April 18, 2023. The study showcases gedatolisib's efficacy through cell viability, proliferation, and flow cytometry assays, emphasizing its differentiated mechanism. The ongoing Phase 3 trial, VIKTORIA-1, is currently enrolling patients for HR+/HER2- advanced breast cancer. These results support further clinical development plans for gedatolisib.

MINNEAPOLIS, MN / ACCESSWIRE / March 1, 2023 / Celcuity (NASDAQ:CELC), a biotechnology company focused on oncology therapies, will participate in Cowen's 43rd Annual Health Care Conference in Boston from March 6-8, 2023. CEO Brian Sullivan is scheduled to present on March 8 at 11:10 a.m. ET. The presentation will be available via live webcast at this link and can also be accessed through the company's Investors section. Celcuity's lead candidate, gedatolisib, is currently being evaluated in a Phase 3 trial for advanced breast cancer.

Celcuity Inc. (NASDAQ:CELC) presented promising preclinical data on gedatolisib at the ASCO Genitourinary Cancers Symposium on February 16, 2023. Gedatolisib showcased superior potency and efficacy in treating prostate cancer cell lines, outperforming other PI3K/AKT/mTOR inhibitors, regardless of PI3K or PTEN status. This suggests its potential to overcome resistance to androgen receptor inhibitors in metastatic castration-resistant prostate cancer (mCRPC). The investigational drug is part of ongoing Phase 1b and Phase 3 clinical trials aimed at advanced breast cancer and solid tumors, respectively. Results imply a significant advancement in targeted cancer therapies.

Celcuity Inc. (NASDAQ:CELC) has successfully closed a private placement yielding approximately $100 million in gross proceeds. This event correlates with the initiation of the Phase 3 clinical trial, VIKTORIA-1, which tests its leading drug, gedatolisib. The funding will support operational needs through 2025 and enable a draw of $20 million from an existing debt facility. Led by Venrock Healthcare Capital Partners and other investors, the private placement includes shares sold at $5.75 each and warrants at a premium. Further details on securities registration are forthcoming.

Celcuity Inc. (Nasdaq: CELC) presented encouraging updates from its Phase 1b trial of gedatolisib for advanced breast cancer at the 2022 San Antonio Breast Cancer Symposium. High response rates were found, with a median progression-free survival (PFS) of 42.3 months for treatment-naïve patients. Efficacy was noted regardless of PIK3CA mutation status, with an overall response rate (ORR) of up to 85%. Celcuity plans further evaluation of gedatolisib combined with CDK4/6 inhibitors and endocrine therapy in future trials, highlighting its unique mechanism of action.