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) reported financial results for Q3 2021, showing a net loss of $6.0 million or $0.41 per share, up from a loss of $2.5 million or $0.24 per share year-over-year. Operating expenses rose to $5.6 million, primarily driven by R&D costs of $5.0 million associated with the gedatolisib program. The company plans to initiate a Phase 3 trial for gedatolisib in early 2022 and update Phase 1b data at the San Antonio Breast Cancer Symposium in December. Cash reserves increased to $90.4 million compared to $11.6 million at year-end 2020.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, announced it will release its third quarter 2021 financial results on November 8, 2021, after the market closes. A webcast and teleconference will follow at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. The company focuses on extending cancer patients' lives through an integrated companion diagnostic and therapeutic strategy, utilizing its CELsignia platform to identify patients likely to benefit from targeted therapies.
Celcuity announced a Phase 2 clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate NERLYNX (neratinib) combined with XELODA (capecitabine) in patients with metastatic HER2-negative breast cancer with brain metastases. The trial, utilizing Celcuity's CELsignia HER2 Activity Test to select patients, aims to find effective treatment options for this underserved group. Interim results are expected within 12-15 months post-enrollment.
Celcuity raised approximately $56.3 million through a follow-on public offering, enhancing its balance sheet to support clinical developments for gedatolisib, a potential first-in-class PI3K/mTOR inhibitor. Following the offering, Celcuity reported $94.4 million in cash on hand. Recent clinical trials showed a promising 65% objective response rate in a Phase 1 study combining gedatolisib with paclitaxel and carboplatin. The company plans to initiate a Phase 2/3 trial for ER+/HER2- metastatic breast cancer in early 2022.
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology firm, will participate in the Canaccord Genuity 41st Annual Growth Conference from August 10-12, 2021. CEO Brian Sullivan will engage in a virtual fireside chat on August 12, 2021, at 8:30 a.m. ET. Interested parties can access the live webcast here or via the company’s Investors page. Celcuity focuses on enhancing cancer patient outcomes through its CELsignia diagnostic platform and related therapeutic strategies.
Celcuity Inc. (Nasdaq:CELC) will release its Q2 2021 financial results on August 9, 2021, after market close. A teleconference is scheduled for 4:30 p.m. Eastern Time on the same day to discuss the results. Celcuity focuses on cancer treatment through an integrated companion diagnostic and therapeutic strategy. Its CELsignia platform analyzes live tumor cells to identify cancer patients who may benefit from targeted therapies. For participation, dial 844-369-8770 (domestic) or 862-298-0840 (international).
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on cancer treatment, will participate in the William Blair Biotech Focus Conference on July 14-15, 2021. CEO Brian Sullivan is scheduled for a fireside chat at 2 p.m. ET on July 15. A live webcast of the chat can be accessed at this link or through the Investors section of Celcuity's website, with a replay available shortly after the live event.
Celcuity utilizes its CELsignia companion diagnostic platform to analyze live cancer cells and identify patients who may benefit from targeted therapies.
Celcuity Inc. (NASDAQ:CELC) announced the pricing of its underwritten public offering, which includes 2,250,000 shares at $25.00 each, aiming for gross proceeds of about $56.25 million. The offering has a 30-day option for underwriters to buy an additional 337,500 shares. Closing is expected on July 1, 2021. Proceeds will support working capital, R&D, and business expansion efforts. The company emphasizes its focus on innovative cancer treatments through its CELsignia platform.
Celcuity Inc. (CELC) announced the launch of an underwritten public offering of its common stock. The offering includes a 30-day option for underwriters to purchase an additional 15% of shares. Proceeds from the offering will be used for working capital and general corporate purposes, including R&D and clinical trials. Jefferies and Cowen are acting as joint bookrunning managers, with additional participation from Canaccord Genuity and Needham & Company. The actual size and terms of the offering remain subject to market conditions.
Celcuity Inc. (NASDAQ:CELC) announced the hiring of two senior executives to strengthen its clinical team: Dr. Igor Gorbatchevsky as VP of Clinical Development and Jill Krause as VP of Clinical Operations. Both leaders bring extensive experience from previous roles in oncology and clinical operations. Celcuity is advancing gedatolisib, a dual inhibitor targeting PI3K/mTOR, with promising Phase 1b trial results. The company plans to initiate a Phase 3 trial for ER+/HER2- metastatic breast cancer, pending FDA feedback, aiming to enhance patient treatment options.
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