Celcuity outlines $2.5B–$3B peak revenue potential for gedatolisib amid accelerated launch preparations

Earnings Call Insights: Celcuity (CELC) Q3 2025

MANAGEMENT VIEW

* CEO Brian Sullivan highlighted significant clinical and regulatory milestones, stating, "We made significant progress achieving a number of clinical and regulatory milestones while also significantly bolstering our balance sheet. These achievements lay the groundwork for us to potentially establish gedatolisib as a new standard of care second-line therapy for patients with HR-positive, HER2-negative advanced breast cancer."
* Sullivan detailed the release of top line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 study, the completion of enrollment for the PIK3CA mutant cohort with expected data in late Q1 or Q2 2026, and the FDA's acceptance of their NDA submission under the real-time oncology review program. "We expect to complete the submission this quarter."
* To support commercialization, Sullivan announced, "We completed concurrent offerings of convertible notes, common stock and prefunded warrants, which resulted in net proceeds of approximately $287 million," and the expansion of their term loan facility to $500 million.
* The CEO emphasized the clinical results: "Median progression-free survival, or PFS, for the gedatolisib triplet...was 9.3 months compared to only 2 months for fulvestrant, which is a 7.3-month incremental improvement in median PFS. The hazard ratio was 0.24."
* Sullivan noted positive safety and efficacy data presented at ESMO and described robust results across subgroups, with a median PFS of 19.3 months in U.S. and Canadian patients receiving the gedatolisib triplet.
* Product launch preparations are advancing, with most commercial hires in place except the field sales force. The company aims for "majority market share" in the target setting and estimates the total addressable market at $5 billion to $6 billion, with potential peak revenues of $2.5 billion to $3 billion for gedatolisib.
* CFO Vicky Hahne reported, "Our third quarter net loss was $43.8 million or $0.92 per share." She added, "We ended the quarter with approximately $455 million of cash, cash equivalents and short-term investments."

OUTLOOK

* The company expects top line data from the PIK3CA mutant cohort of the VIKTORIA-1 trial in late Q1 or Q2 2026.
* Sullivan stated, "We expect to complete the submission [to FDA] this quarter." The addressable market for gedatolisib in the second-line setting is estimated at $5 billion to $6 billion, and the company projects potential peak revenues of $2.5 billion to $3 billion.
* Celcuity expects existing cash and debt resources to fund operations through 2027.

FINANCIAL RESULTS

* Hahne reported, "Our third quarter net loss was $43.8 million or $0.92 per share compared to $29.8 million net loss or $0.70 per share for the third quarter of 2024."
* "Research and development expenses were $34.9 million for the third quarter of 2025 compared to $27.6 million for...2024."
* "General and administrative expenses were $7.9 million for the third quarter of 2025 compared to $2.5 million for...2024."
* "Net cash used in operating activities for the third quarter of 2025 was $44.8 million compared to $20.6 million for...2024."
* The company completed offerings resulting in net proceeds of $287 million and expanded its loan facility to $500 million.

Q&A

* Maurice Raycroft, Jefferies: Asked about additional data at San Antonio and subpopulation analysis. Sullivan responded, "Typically, these presentations...include additional subgroup analyses for efficacy, additional data that might relate to certain safety or quality of life aspects of the study."
* Raycroft also inquired on VIKTORIA-2 enrollment and frontline expansion. Sullivan replied enrollment is on track and any expansion decisions will be announced as plans develop.
* Samantha (for Andy Berens, Leerink Partners): Asked about real-time oncology review process and mutant submission. Sullivan clarified, "We're on track...with the submission for the wild-type cohort completed by the end of this quarter... We would, depending on the data, request a real-time oncology review for the mutant data, but it's always a function of the data."
* Tara Bancroft, TD Cowen: Inquired about duration of therapy and pricing strategy. Sullivan referenced U.S. PFS of 19.3 months and cited recent therapeutic benchmarks around $25,000, noting, "We haven't made a final decision on our pricing approach."
* Bradley Canino, Guggenheim: Asked about ex-U.S. commercialization. Sullivan stated, "We expect to commercialize in the U.S. and...find a partner or partners to commercialize the drug ex U.S." Final decisions await mutant data and regulatory progress.
* Dara Azar, Stifel: Asked about frontline population strategy. Sullivan indicated a strong rationale exists for developing gedatolisib in treatment-naïve patients, but study design decisions are pending.
* Oliver McCammon, LifeSci: Asked about overall survival data and its regulatory impact. Sullivan noted interim hazard ratios below 1 and said, "We believe is a favorable trend...and we think that, that supports our submission for drug approval."
* Jacob Soucheray, Craig-Hallum: Asked about domestic manufacturing. Sullivan said Celcuity uses multiple sites and is taking steps to ensure supply chain flexibility and robustness.

SENTIMENT ANALYSIS

* Analysts focused on data details, regulatory processes, commercial strategy, pricing, and manufacturing, with a tone that was inquisitive but largely neutral.
* Management maintained a confident and detailed tone in prepared remarks and Q&A, frequently referencing favorable data and robust preparations. Sullivan stated, "We believe obtaining majority market share in this setting appears not only achievable, but potentially too conservative."
* Compared to the previous quarter, both analyst and management sentiment remain steady, with management showing increased confidence in commercialization and market penetration.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter emphasized regulatory milestones (NDA submission, FDA engagement), advanced launch preparations, and a clear revenue target, compared to the previous quarter's focus on clinical data readouts and patent extension.
* Guidance now includes specific timing for mutant cohort data and clear projections for addressable market size and potential peak revenue.
* Analysts continue to focus on data depth, regulatory clarity, and commercial execution.
* Management's confidence has grown, with more assertive statements on market share and commercial strategy.

RISKS AND CONCERNS

* Management highlighted reliance on pending data for mutant cohort and regulatory approvals for broader indications.
* Supply chain flexibility and readiness were discussed as part of launch risk mitigation.
* Analyst questions indicated concern about pricing, payer acceptance, and ex-U.S. commercialization timelines.

FINAL TAKEAWAY

Celcuity management emphasized the transformative potential of gedatolisib, highlighting robust clinical results, advanced regulatory progress, and aggressive preparations for a commercial launch. With financial resources secured, clear revenue expectations, and positive market feedback, the company projects strong momentum as it approaches potential FDA approval and aims for significant market share in HR-positive, HER2-negative advanced breast cancer.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/celc/earnings/transcripts]

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* Celcuity Inc. (CELC) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4842858-celcuity-inc-celc-q3-2025-earnings-call-transcript]
* Celcuity: Updated Gedatolisib Data Bodes Well For Mutant-Type Cohort Results [https://seekingalpha.com/article/4831616-celcuity-updated-gedatolisib-data-bodes-well-for-mutant-type-cohort-results]
* Celcuity Inc. (CELC) Discusses Additional Results From Phase III VIKTORIA-1 Trial and Insights Into PAM Pathway Targeting - Slideshow [https://seekingalpha.com/article/4831259-celcuity-inc-celc-discusses-additional-results-from-phase-iii-viktoriaminus-1-trial-and]
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* Celcuity soars on phase 3 data for gedatolisib in breast cancer [https://seekingalpha.com/news/4505617-celcuity-soars-phase-3-data-gedatolisib-breast-cancer]