Celcuity Inc. (CELC)
NASDAQ (CM) NASDAQ (CM) Primary 
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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.
Celcuity: Updated Gedatolisib Data Bodes Well For Mutant-Type Cohort Results
Celcuity Inc. remains a Strong Buy, driven by positive Phase 3 VIKTORIA-1 data for gedatolisib in 2nd-line PIK3CA wild type HR+/HER2- advanced breast cancer patients. Company expects to complete a rolling NDA submission for gedatolisib under the FDA RTOR program by Q4 2025, targeting wild-type PIK3CA advanced breast cancer patients. CELC can potentially move to targeting 1st-lne PIK3CA mutant and wild-type HR+/HER2- advanced breast cancer patients with ongoing phase 3 VIKTORIA-2 study.
Celcuity Inc. (CELC) Discusses Additional Results From Phase III VIKTORIA-1 Trial and Insights Into PAM Pathway Targeting Transcript
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: Blink And You Missed It
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. (CELC) Q2 2025 Earnings Call Transcript
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: Positive Phase 3 Wild-Type ABC Data With Gedatolisib Leads To End Of 2025 Catalyst
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: What's Happening With CELC Stock?
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 Blasting Off After Late-Stage Trial Results
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's triple cancer drug combo tops AstraZeneca's in cutting progression in study
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. (CELC) Q1 2025 Earnings Call Transcript
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.
