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Overview of Celcuity Inc.
Celcuity Inc. (Nasdaq: CELC) is a clinical-stage biotechnology company specializing in the development of targeted therapies and companion diagnostics for oncology. Based in Minneapolis, Celcuity aims to transform cancer treatment by leveraging precision medicine to improve therapeutic outcomes for patients with advanced solid tumors. The company’s innovative approach focuses on addressing critical gaps in cancer care by combining its proprietary diagnostic platform with cutting-edge therapeutic candidates.
Therapeutic Innovations: Gedatolisib
Celcuity’s lead therapeutic candidate, gedatolisib, is a potent, reversible inhibitor targeting the PI3K/AKT/mTOR signaling pathway, a critical driver in many cancers. Unlike other therapies that selectively inhibit individual components of this pathway, gedatolisib uniquely targets all Class I PI3K isoforms as well as mTORC1 and mTORC2. This comprehensive mechanism of action minimizes the potential for drug resistance, making it a highly differentiated candidate among currently approved and investigational therapies. Gedatolisib has demonstrated robust clinical efficacy and a manageable safety profile in Phase 1b trials, particularly in patients with HR+/HER2- advanced breast cancer.
The drug is currently being evaluated in multiple clinical trials, including:
- VIKTORIA-1: A Phase 3 trial assessing gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with HR+/HER2- advanced breast cancer.
- CELC-G-201: A Phase 1b/2 trial exploring gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer.
- VIKTORIA-2: An upcoming Phase 3 trial investigating gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer in combination with a CDK4/6 inhibitor and fulvestrant.
Diagnostic Breakthrough: CELsignia Platform
Complementing its therapeutic efforts, Celcuity has developed the CELsignia companion diagnostic platform, a proprietary technology designed to analyze live tumor cells and identify patients most likely to benefit from specific targeted therapies. Unlike traditional genomic or proteomic diagnostics, CELsignia assesses the functional activity of signaling pathways in real-time, providing actionable insights for personalized treatment strategies. This platform has the potential to redefine patient selection and improve clinical trial outcomes by identifying previously unrecognized patient subgroups.
Strategic Positioning in Oncology
Celcuity operates at the forefront of precision oncology, a rapidly growing segment of the biotechnology industry. By combining innovative drug development with advanced diagnostics, the company addresses the increasing demand for personalized medicine. Its focus on solid tumor indications, particularly HR+/HER2- advanced breast cancer and metastatic prostate cancer, positions it within high-need therapeutic areas. The FDA’s Breakthrough Therapy designation for gedatolisib underscores its potential to deliver significant clinical benefits.
Challenges and Opportunities
As a clinical-stage biotechnology company, Celcuity faces challenges typical of its industry, including the high costs and risks associated with clinical trials and regulatory approvals. However, its differentiated approach and robust pipeline provide significant opportunities for growth. The company’s focus on combination therapies and its ability to address resistance mechanisms in cancer treatment set it apart from competitors.
Conclusion
Celcuity Inc. is a pioneering force in the biotechnology sector, combining innovative targeted therapies with advanced diagnostic solutions to address unmet needs in oncology. Its dual focus on gedatolisib and the CELsignia platform highlights its commitment to advancing precision medicine and improving patient outcomes. With multiple clinical trials underway and a strong foundation in personalized oncology, Celcuity is well-positioned to make a lasting impact on cancer treatment.
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on cancer treatment, will have its CEO Brian Sullivan participate in virtual investor meetings at two upcoming conferences. The 12th Annual Craig-Hallum Alpha Select Conference is scheduled for November 16, 2021, followed by the Jefferies London Healthcare Conference on November 18-19, 2021. Celcuity utilizes a unique CELsignia companion diagnostic platform to identify patients who could benefit from targeted therapies by analyzing live tumor cells.
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.
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