Welcome to our dedicated page for Celcuity news (Ticker: CELC), a resource for investors and traders seeking the latest updates and insights on Celcuity stock.
Celcuity Inc. (Nasdaq: CELC) is a cutting-edge biotechnology company committed to developing targeted therapies for oncology. The company's proprietary functional cellular analysis platform offers a unique approach to personalized medicine by assessing the functionality of disease-related signaling pathways directly from a patient's diseased cells ex vivo. This innovative technology provides specific insights into how effectively a drug therapy impacts a patient's tumor cells, thereby transforming the treatment paradigm.
Celcuity's lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that targets all Class I PI3K isoforms and mTOR. Gedatolisib exhibits a highly differentiated mechanism of action and pharmacokinetic properties compared to other approved and investigational therapies that focus on PI3K or mTOR pathways individually or together. The company is actively pursuing multiple clinical trials to explore the efficacy of gedatolisib in various oncology indications.
Currently, Celcuity is enrolling patients for its Phase 3 VIKTORIA-1 clinical trial, which evaluates gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer. The Phase 1b/2 clinical trial (CELC-G-201) is assessing gedatolisib in combination with darolutamide for treating metastatic castration-resistant prostate cancer (mCRPC).
In recent preclinical studies, gedatolisib has been shown to be more effective than single node PAM inhibitors in controlling crucial cellular functions necessary for cancer cell survival and proliferation. These promising results underline the potential of gedatolisib as a transformative treatment option for multiple solid tumor indications.
Celcuity has also announced the initiation of the Phase 3 VIKTORIA-2 clinical trial, which will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer in patients who are endocrine therapy resistant. The trial is expected to start enrolling patients in the second quarter of 2025 and aims to add significant value to existing treatment protocols.
Celcuity's financial health is robust, supported by recent equity placements and a substantial debt facility agreement, which provides adequate capital to fund their operational activities into 2026. Further information about Celcuity, its pipeline, and ongoing clinical trials can be found on their official website.
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.
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