Celcuity Inc. (NASDAQ:CELC ) Discusses Additional Results From Phase III VIKTORIA-1 Trial and Insights Into PAM Pathway Targeting October 20, 2025 8:00 AM EDT Company Participants Brian Sullivan - Co-Founder, Chairman & CEO Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Maurice Raycroft - Jefferies LLC, Research Division Tara Bancroft - TD Cowen, Research Division Andrew Berens - Leerink Partners LLC, Research Division Stephen Willey - Stifel, Nicolaus & Company, Incorporated, Research Division Gil Blum - Needham & Company, LLC, Research Division Presentation Operator Hello, and thank you for standing by. My name is Bella, and I will be your conference operator today.
Celcuity (CELC) surges to a $2B valuation on strong phase 3 data for gedatolisib in hormone-positive breast cancer, affirming commercial potential. Gedatolisib shows significant progression-free survival benefits in VIKTORIA-1, with manageable discontinuation rates and a $5B market opportunity targeted by CELC. Recent fundraising and loan facilities secure CELC's cash runway into 2027, supporting NDA filing, potential approval, and initial launch.
Celcuity Inc. (NASDAQ:CELC ) Q2 2025 Earnings Conference Call August 14, 2025 4:30 PM ET Company Participants Brian F. Sullivan - Co-Founder, Chairman & CEO Vicky Hahne - Chief Financial Officer Conference Call Participants Chase Richard Knickerbocker - Craig-Hallum Capital Group LLC, Research Division Eason Lee - Leerink Partners LLC, Research Division Frances Dovell - TD Cowen, Research Division Gil Joseph Blum - Needham & Company, LLC, Research Division Mohamad Amin Makarem - Jefferies LLC, Research Division Stephen Douglas Willey - Stifel, Nicolaus & Company, Incorporated, Research Division Apoorva Chaloori - Unidentified Company Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2025 Financial Results Webcast and Conference Call.
Celcuity's phase 3 VIKTORIA-1 trial showed gedatolisib significantly improved progression-free survival in PIK3CA wild-type HR+/HER2- advanced breast cancer patients. NDA submission for gedatolisib in 2nd-line PIK3CA wild-type HR+/HER2- ABC patients is planned for Q4 2025, with expansion to mutant and 1st-line cohorts underway as well. Strong market opportunity exists as HR+/HER2- breast cancer represents 70% of all breast cancers; Data from PIK3CA-mutant cohort expected by end of 2025.
Celcuity stock (NASDAQ: CELC), a clinical-stage biotechnology company, experienced an extraordinary 3x surge in a single trading session, with shares rocketing from approximately $14 to a peak of $46 before stabilizing around $37. This dramatic price movement was triggered by positive topline results from the PIK3CA wild-type cohort of the company's Phase 3 VIKTORIA-1 clinical trial for gedatolisib, a targeted therapy for HR+/HER2- breast cancer.
Biotech stock Celcuity Inc (NASDAQ:CELC) is skyrocketing today, up 221% at $43.76 at last glance, after upbeat phase 3 trial results for its advanced breast cancer therapy, gedatolisib, which it hopes will have Food & Drug Administration (FDA) approval by the end of the year.
Celcuity said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer, sending the biotech firm's shares surging more than twofold in premarket trading.
Celcuity Inc. (NASDAQ:CELC ) Q1 2025 Earnings Conference Call May 14, 2025 4:30 PM ET Company Participants Apoorva Chaloori - ICR Healthcare Brian Sullivan - Chief Executive Officer and Co-Founder Vicky Hahne - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Tara Bancroft - TD Cowen Gil Blum - Needham and Company Oliver McCammon - LifeSci Capital Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity First Quarter 2025 Financial Results Webcast Conference Call. At this time all lines are in listen-only mode.
Celcuity Inc. (NASDAQ:CELC ) Q4 2024 Earnings Conference Call March 31, 2025 4:30 PM ET Company Participants Apoorva Chaloori - ICR Healthcare, Investor Relations Brian Sullivan - Co-Founder & Chief Executive Officer Vicky Hahne - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Brad Canino - Stifel Oliver McCammon - LifeSci Capital Gil Blum - Needham Corporation Chase Knickerbocker - Craig-Hallum Capital Group Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Fourth Quarter and Full Year 2024 Financial Results Webcast Conference Call. [Operator Instructions] I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare.
Celcuity's gedatolisib, a pan-PI3K/mTOR inhibitor for advanced breast cancer, shows strong early efficacy and is in pivotal Phase 3 trials, yet remains undervalued. The company has a healthy cash position with 13 quarters of runway but faces high R&D expenses and no revenue stream, making it reliant on future funding. Gedatolisib's dual inhibition of PI3K and mTOR may offer a differentiated safety profile and efficacy, potentially capturing market share in breast and prostate cancer.
Celcuity Inc. (NASDAQ:CELC ) Q3 2024 Earnings Conference Call November 14, 2024 4:30 PM ET Company Participants Apoorva Chaloori - ICR Westwicke, Investor Relations Brian Sullivan - Co-Founder & Chief Executive Officer Vicky Hahne - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Brad Canino - Stifel Tara Bancroft - TD Cowen Chase Knickerbocker - Craig Hallum Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Third Quarter 2024 Financial Results Conference Call. At this time, all lines are in listen-only mode.
The consensus price target hints at an 87.6% upside potential for Celcuity (CELC). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.