Celcuity Inc. (CELC) Earnings

Management highlights

### Clinical Development Updates - Recently reported positive top-line results for the PIK3CA mutant cohort of the Phase 3 Victoria 1 trial for gadotelicib in HR-positive HER2-negative advanced breast cancer. Both the gadotelicib triplet (combined with fulvestrant and cabociclib) and doublet (combined with fulvestrant) achieved statistically and clinically significant improvements in progression-free survival (PFS) compared to the current standard of care single-target PIK3 inhibitor, with manageable safety and no new safety signals. Detailed results will be presented at the 2026 ASCO meeting on June 2nd. - Announced an expansion of the Phase 3 Victoria 2 trial to add a second arm evaluating gadotelicib as first-line treatment for endocrine-sensitive HR-positive HER2-negative advanced breast cancer, in addition to the original endocrine-resistant cohort. The amendment positions the trial to evaluate gadotelicib in ~90,000 newly diagnosed U.S. patients annually, regardless of endocrine sensitivity or PIK3CA status. Top-line data is expected by the end of 2028 for the endocrine-resistant cohort and 2030 for the new endocrine-sensitive cohort. The FDA provided aligned feedback on the amended trial design during a pre-submission Type B meeting. - Initiated development of a subcutaneous (sub-Q) formulation of gadotelicib for long-term treatment indications, and has submitted the first patent application for the new formulation to the USPTO. The sub-Q formulation is intended as an alternative to the current intravenous (IV) formulation for patients who may receive treatment for multiple years. - Phase 1b trial of gadotelicib plus darolutamide for metastatic castration-resistant prostate cancer (mCRPC) shows promising interim results: the six-month radiographic PFS rate was 67% (compared to a historical 40% for second-line AR inhibitor treatment), with a 9.1 month median radiographic PFS, and no dose-limiting toxicities or treatment discontinuations due to adverse events. Enrollment is ongoing, with a data update expected at an upcoming medical conference. ### Commercial Preparation - Completed hiring and onboarding of the entire field sales force of oncology specialists for the planned potential Q3 2026 launch of gadotelicib following FDA approval. The average sales representative has 24 years of pharmaceutical sales experience and 16 years of oncology experience. - Ongoing extensive outreach to payers, health systems, integrated delivery networks, and community oncology practices. Market research indicates strong willingness to prescribe from oncologists, and payer feedback to date has been encouraging. - The estimated annual total addressable market for gadotelicib in the second-line setting is over $5 billion, with an estimated peak annual revenue potential of up to $2.5 billion for this indication. ### Financial Performance - R&D expense increased YoY due to higher employee/consulting and manufacturing costs, partially offset by lower clinical trial costs for the completed Victoria 1 trial. - SG&A expense increased YoY primarily due to hiring for commercial preparation and other launch-related activities. - As of March 31, 2026, the company held $387.1 million in cash, cash equivalents, and short-term investments.

Guidance

- Management expects existing cash, cash equivalents, short-term investments, and available draws on the company's debt facility are sufficient to fund operations through 2027. - Management maintains the expectation that a potential FDA approval of gadotelicib and commercial launch will occur in Q3 2026, aligned with the July 17 PDUFA decision date. No off-track issues have been identified in FDA interactions to date. - Top-line data for the Victoria 2 endocrine-resistant cohort is expected by the end of 2028, with top-line data for the new endocrine-sensitive cohort expected by the end of 2030. - Management targets to have the sub-Q formulation of gadotelicib approved around the same timeline as the expected approval for the first-line endocrine-sensitive indication.

Segment performance

Salcuity is a clinical-stage biotech with no commercial product sales as of Q1 2026. Total operating expenses were $50.5 million for the quarter: Research and Development (R&D) expenses were $33.1 million (65.5% of total operating expenses), an increase of $3.3 million year-over-year (YoY). Selling, General, and Administrative (SG&A) expenses were $17.4 million (34.5% of total operating expenses), an increase of $11.1 million YoY. Net loss was $52.8 million ($0.97 per share) in Q1 2026, compared to a $37 million net loss ($0.86 per share) in Q1 2025. Non-GAAP adjusted net loss was $46.8 million ($0.86 per share) in Q1 2026, compared to $34.7 million ($0.81 per share) in Q1 2025.

Risks & headwinds

- All forward-looking statements regarding clinical trial results, regulatory approval, and commercial launch are subject to inherent risks and uncertainties, and actual outcomes may differ materially from projected results. These risks include potential failure to meet clinical efficacy or safety endpoints, unexpected regulatory delays or requirements, and failure to achieve projected commercial adoption or revenue. - The sub-Q formulation development program faces technical and regulatory risks: the company may fail to achieve a stable, clinically equivalent formulation, and the FDA is expected to require a phase 3 equivalence trial for approval, which adds time and development risk. - Clinical trial results cannot be guaranteed; even with positive preliminary data, the Victoria 2 trial may fail to demonstrate a clinically meaningful benefit relative to the current standard of care. - Payers may not provide favorable coverage or reimbursement terms for gadotelicib following approval, which could negatively impact commercial adoption and revenue.

Analyst Q&A

• Q: What updates can you provide on FDA interactions ahead of the July 17 PDUFA date, including labeling discussions? /

  A: Management declined to provide detailed specifics on regulatory interactions. They confirmed that nothing in interactions to date suggests the FDA decision will be delayed from the scheduled July 17 PDUFA date.

• Q: What is the regulatory and development timeline for the subcutaneous gadotelicib formulation, and could it be used in the Victoria 2 trial? /

  A: Development progresses through formulation optimization, manufacturing scale-up, stability testing, and phase 1 PK studies to confirm equivalence to the IV formulation, followed by an expected required phase 3 equivalence trial. Management targets to have the sub-Q formulation approved aligned with the expected approval for the first-line endocrine-sensitive indication. There are no current plans to use it in the Victoria 2 trial.

• Q: How does Salcuity see gadotelicib's competitive positioning versus existing and developmental single-target PIK3 inhibitors? /

  A: Management notes that the Victoria 1 trial demonstrated gadotelicib's multi-target PAM pathway inhibition is statistically and clinically superior to the standard single-target PIK3 inhibitor. They stated that single-target inhibition has limited biological potential for treatment effect, and the efficacy data confirms gadotelicib's differentiated advantage over existing and developmental competitive approaches.

• Q: How ready is Salcuity for a potential launch ahead of the PDUFA date, in light of recent early oncology approvals that came ahead of schedule? /

  A: Management states their governing assumption remains that approval will come in line with the July 17 PDUFA date, consistent with historical priority review timelines. They confirm the company has an internal launch-ready date set before the PDUFA date, so the full commercial team and infrastructure will be prepared to launch immediately if an early approval is granted.

• Q: What is the commercial preparation status ahead of ASCO and potential launch, and what payer feedback have you received? /

  A: Management notes ASCO is a key staging ground for pre-launch outreach, with a large team of medical professionals scheduled to engage practicing oncologists to share results ahead of the potential Q3 launch. They have conducted extensive payer engagement for nearly a year, and feedback to date has been very encouraging. They are well-positioned to move forward expeditiously with coverage discussions once approval is granted.