Celcuity Inc. (CELC)
NASDAQ (CM) NASDAQ (CM) Primary Summary
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Celcuity: From Speculative Bet To Pre-Commercial Powerhouse
Celcuity has transitioned from a speculative biotech to a de-risked pre-commercial firm, driven by unprecedented Phase 3 VIKTORIA-1 trial results. Celcuity's gedatolisib demonstrated significant efficacy and a favorable safety profile in HR+/HER2- advanced breast cancer, supporting a strong investment thesis. With a completed NDA under the FDA's RTOR program and a $455M cash position, CELC is well-funded for commercialization and pipeline expansion.
Celcuity Inc. (CELC) Q3 2025 Earnings Call Transcript
Celcuity Inc. ( CELC ) Q3 2025 Earnings Call November 12, 2025 4:30 PM EST Company Participants Brian Sullivan - Co-Founder, Chairman & CEO Vicky Hahne - Chief Financial Officer Conference Call Participants Apoorva Chaloori Maurice Raycroft - Jefferies LLC, Research Division Tara Bancroft - TD Cowen, Research Division Bradley Canino - Guggenheim Securities, LLC, Research Division Dara Azar - Stifel, Nicolaus & Company, Incorporated, Research Division Oliver McCammon - LifeSci Capital, LLC, Research Division Jacob Soucheray - Craig-Hallum Capital Group LLC, Research Division Presentation Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity's Third Quarter 2025 Financial Results Webcast and Conference Call. [Operator Instructions] I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare.
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Celcuity Inc. Profile
| Biotechnology Industry | Healthcare Sector | Brian F. Sullivan CEO | NASDAQ (CM) Exchange | 15102K100 CUSIP |
| US Country | 87 Employees | - Last Dividend | - Last Split | - IPO Date |
Overview
Celcuity Inc. is a clinical-stage biotechnology company based in Minneapolis, Minnesota, established in 2011. It is primarily engaged in the development of targeted therapies for the treatment of various solid tumors. By focusing on personalized medicine, Celcuity aims to advance the treatment of cancer through its innovative CELsignia diagnostic platform. This platform utilizes living tumor cells from patients to pinpoint the specific abnormal cellular processes driving their cancer. An essential aspect of their operation includes a strategic license agreement with Pfizer, Inc., granting them the development and commercialization rights to Gedatolisib, one of their leading drug candidates.
Products and Services
- CELsignia Diagnostic Platform:
This groundbreaking platform represents the core of Celcuity's technological advancement. It is designed to analyze living tumor cells to determine the specific abnormal cellular activity causing a patient's cancer. The analysis enables the identification of targeted therapies that are most likely to be effective for each patient, personalizing the treatment approach to cancer care.
- Gedatolisib:
As a leading drug candidate in Celcuity's portfolio, Gedatolisib is being developed to selectively target and inhibit the activity of class I isoforms of phosphoinositide 3-kinase (PI3K) and mammalian target of rapamycin (mTOR). These enzymes are often involved in the growth and spread of cancer cells. Gedatolisib is currently focused on the treatment of patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, and metastatic castration-resistant prostate cancer. The development and potential commercialization of Gedatolisib are underpinned by a license agreement with Pfizer, Inc., illustrating Celcuity's collaborative efforts with industry leaders to bring new cancer therapies to market.
Contact Information
