Celcuity Inc. (CELC) Presents at TD Cowen 46th Annual Health Care Conference Transcript
The portfolio meaningfully outperformed the MSCI EAFE Small Cap Growth Index but modestly lagged the blend MSCI ACWI ex USA SMID Index. Our portfolio, which has a structural growth orientation, has no exposure to these cyclical, capital-intensive and highly regulated market segments. On an individual company basis, Metso, Celcuity and LivaNova were the largest Q4 contributors.
Perceptive Advisors purchased 203,881 Celcuity shares in the fourth quarter; the estimated trade value was $16.76 million based on average fourth-quarter pricing. Meanwhile, the quarter-end position value rose by $169.16 million, reflecting both share additions and price movements.
Celcuity Inc. (CELC) Presents at Guggenheim Securities Emerging Outlook: Biotech Summit 2026 Transcript
Here is how Celcuity, Inc. (CELC) and Day One Biopharmaceuticals, Inc. (DAWN) have performed compared to their sector so far this year.
CELC shares surge as NDA filing and strong phase III data boost optimism around gedatolisib's potential.
Celcuity Inc. surged over 750% in 2025 on best-in-class Phase 3 data for gedatolisib in HR+/HER2- advanced breast cancer. GEDATOLISIB demonstrated superior efficacy and safety versus standards of care, with median PFS of 9.3 months in VIKTORIA-1 and favorable adverse event profile. Management projects peak revenues of $2.5–$3 billion for gedatolisib; current cash position is nearly $500 million, supporting regulatory and commercial milestones.
After a weak first half, the drug and biotech sector has recovered in the past 2-3 months with large drugmakers like Pfizer, AstraZeneca, Eli Lilly and Novo Nordisk signing drug pricing agreements with the Trump administration. A rebound in mergers and acquisitions (M&A) has also increased investor confidence in the industry.
Many investors have profited from the artificial intelligence (AI) trade in 2025. But there have been several up-and-coming stocks in other sectors that have posted impressive gains this year.
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 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 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.