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.
Celcuity (CELC) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Celcuity Inc. (NASDAQ:CELC ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 AM ET Company Participants Maria Yonkoski - ICR Westwicke, IR Brian Sullivan - Co-Founder and CFO Vicky Hahne - Chief Financial Officer Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Maury Raycroft - Jefferies Tara Bancroft - TD Cowen Brad Canino - Stifel Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2024 Financial Results Conference Call. At this time all lines are in listen-only mode.