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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 developing targeted oncology therapies, has announced its participation in two upcoming investor conferences.
Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, will represent the company at both events where he will present and be available for one-on-one investor meetings.
The first appearance will be a fireside chat at the TD Cowen 45th Annual Health Care Conference in Boston on Tuesday, March 4, 2025, at 10:30 a.m. ET. The second presentation will take place at the Leerink Global Healthcare Conference 2025 in Miami on Wednesday, March 12, 2025, at 9:20 a.m. ET.
Live webcasts of both presentations will be available through dedicated weblinks provided in the announcement.
Celcuity (CELC) announced overall survival (OS) data from a Phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy for HR+, HER2- advanced breast cancer. The study showed promising results with a median OS of 77.3 months in treatment-naïve patients and 33.9 months in patients previously treated with CDK4/6 inhibitors.
The data was presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The trial results support Celcuity's clinical development strategy of simultaneously blocking ER, CDK4/6, and PAM signaling pathways, which forms the basis for their ongoing VIKTORIA-1 and planned VIKTORIA-2 Phase 3 trials.
Celcuity Inc. (CELC) announced its Q3 2024 financial results and corporate updates. The company reported 100% enrollment completion for the PIK3CA wild-type cohort in the Phase 3 VIKTORIA-1 trial, with topline data expected in late Q1 2025 or Q2 2025. The PIK3CA mutant cohort data is anticipated in H2 2025. Financial highlights include $264.1 million in cash and investments, expected to fund operations through 2026. Q3 operating expenses were $30.1 million, with a net loss of $29.8 million ($0.70 per share). R&D expenses increased to $27.6 million, primarily due to clinical trial activities and increased personnel costs.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on oncology targeted therapies, has announced upcoming presentations at two major investor conferences. CEO and Co-founder Brian Sullivan will participate in fireside chats at the Stifel 2024 Healthcare Conference on November 19 at 1:15 p.m. ET and the Jefferies London Healthcare Conference on November 21 at 11:30 a.m. GMT/6:30 a.m. ET. Both events will feature live webcasts and one-on-one investor meetings.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company focused on targeted oncology therapies, has announced it will release its third quarter 2024 financial results after market close on Thursday, November 14, 2024. The company will host a webcast and conference call at 4:30 p.m. Eastern Time on the same day to discuss results and provide a corporate update. Domestic callers can dial 1-800-717-1738, while international callers should use 1-646-307-1865 to participate.
Celcuity Inc. (Nasdaq: CELC) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Plan to initiate Phase 3 VIKTORIA-2 trial for gedatolisib in HR+, HER2- advanced breast cancer, with first patient enrollment expected in Q2 2025.
2. VIKTORIA-1 PIK3CA WT cohort enrollment target expected in Q4 2024, with topline data anticipated in late Q4 2024 or Q1 2025.
3. Raised $129 million in gross proceeds from equity and debt financings, extending operational runway through 2026.
4. Q2 2024 financial results: Total operating expenses of $24.3 million, net loss of $23.7 million ($0.62 per share), and cash position of $283.1 million as of June 30, 2024.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced the schedule for its second quarter 2024 financial results release. The company will disclose its financial performance after the market closes on Wednesday, August 14, 2024. Following the release, management will host a webcast and teleconference at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.
Investors and interested parties can participate in the teleconference by dialing 1-800-717-1738 (domestic) or 1-646-307-1865 (international). Additionally, a live webcast presentation will be accessible via the provided weblink. For those unable to attend the live event, a replay of the webcast will be made available on the Celcuity website.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology firm focused on oncology therapies, announced its participation in the Jefferies Global Healthcare Conference from June 4-6, 2024, in New York.
Brian Sullivan, CEO and Co-founder, will engage in a fireside chat at 10:00 a.m. ET on June 6, 2024.
The event will be webcast live at this link: https://wsw.com/webcast/jeff302/celc/1809904, and accessible via the Investors section on Celcuity's website, with a replay available soon after.
Celcuity (NASDAQ: CELC), a clinical-stage biotechnology company, announced the pricing of an underwritten offering of 3,871,000 shares of common stock at $15.50 per share, aiming to raise $60 million. Notable investors include BVF Partners L.P., Vivo Capital, and Eventide Asset Management. The offering is expected to close by May 31, 2024, pending customary conditions.
Proceeds are earmarked for working capital, corporate purposes, and a Phase 3 trial for advanced breast cancer treatment. Combined with existing cash and investments, these funds should cover expenses through late 2026. Leerink Partners, TD Cowen, and Stifel are joint bookrunning managers. The offering is registered under a previous SEC filing.
Celcuity announced plans to initiate a Phase 3 trial for gedatolisib as first-line treatment for HR+/HER2- advanced breast cancer. The trial will assess gedatolisib combined with a CDK4/6 inhibitor and fulvestrant, targeting patients resistant to endocrine therapy. Initial trial results show promising efficacy, with a median progression-free survival of 48.6 months and an overall response rate of 79% in Phase 1b. Additionally, Celcuity secured $62 million in debt financing to support this initiative, amending its agreement with Innovatus Capital Partners and adding Oxford Finance as a new lender, increasing the total debt facility to $180 million. The Phase 3 trial, named VIKTORIA-2, will involve approximately 638 subjects across 200 global sites, with enrollment beginning in Q2 2025.
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