STIFEL 2026 HEALTHCARE CONFERENCE - CELCUITY INC

Explicit Guidance:

• No specific revenue, earnings, margin, or cash flow guidance provided.
• Timeline Guidance:
  • PIK3CA mutant (SND-A) Approval: Expected decision (PDUFA) at the end of Q2 (late June).
  • Phase 3 Prostate Cancer Study: Expected completion in 2027 to determine definitive dose (likely 240 mg) and patient population.
  • Prostate Registrational Study: Expected to follow Phase 2 completion in 2027, assuming data consistency.
  • First-Line Breast Cancer Trial Enrollment: Aiming to advance to submission within "the next few years" following enrollment.
  • Second Supplier Capacity: New supplier expected to be online in the "middle part of next year" (H2 2026) to provide redundancy; full capacity required in 2028.
  • European Supply: Third manufacturer currently in process for European supply.

Business-Segment Outlook:

• RevTropic (Breast Cancer) Launch:
  • Current Status: Five weeks post-launch; 90+ percent of patients have reimbursement policies in place; 80 percent of 36 strategic accounts (covering >1,000 sites) have placed orders; field reps have engaged 3,400+ accounts treating 80+ percent of breast cancer patients.
  • Utilization Patterns: Anecdotal feedback suggests bulk of volume is from patients with progressive disease (not salvage switching); preference for triplet regimens over doublets; second-line setting expected to be primary volume driver initially.
  • Ordering Behavior: Distribution model (direct to infusion centers) results in just-in-time ordering; sites may order single vials or cycles (3 vials) depending on patient load; minimal inventory stocking expected.
  • Market Size: Addressable market estimated at roughly $9 billion based on pricing and treatment duration; time to peak penetration projected at 30–42 months (avg. 36 months) based on first-drug launch analogs.
• PIK3CA Mutant Indication (VIC-1):
  • Submission: SND-A submitted; pending PDUFA.
  • Labeling Outlook: High probability of triplet indication approval; doublet approval uncertain due to lack of pre-specified alpha in analysis, creating a "complex review" and likely preventing priority review status.
  • Clinical Rationale: Triplet regimen demonstrates significant differentiation over doublet, particularly in patients without liver metastases (21.5 months PFS vs. 11.5 months for doublet).
• First-Line Breast Cancer:
  • Trial Status: Two Phase 3 studies ongoing; preliminary data shows 48-month median PFS vs. historical 25 months for SOC.
  • Market Potential: 90,000 patients potentially indicated if trials read out positively; 60,000 patients eligible if approved.
  • Success Probability: Management views probability of success as "high."
• Prostate Cancer (mCRPC):
  • Data Trend: Dose-dependent improvement in PSA reduction observed up to 300 mg.
  • Dosing: 240 mg identified as most likely dose for subsequent studies due to improved tolerability profile (lower stomatitis) compared to 180 mg.
  • Strategy: Proceeding to Phase 2 completion to define dose and population before potential registrational study.

Market and Competitive Outlook:

• Competitive Landscape: RevTropic positioned as "first-best alternative" in PIK3CA wild-type second-line setting; expected to displace standard endocrine therapies and ADCs.
• ESR1 Mutant Segment (20% of market): Facing competition from Eli Lilly's Abemaciclib/Imlifide and Roche's Gilteritinib/Nebrolimus; RevTropic triplet offers 2x greater likelihood of PFS/death vs. doublet competitors based on meta-analysis.
• Market Dynamics:
  • Pricing/Reimbursement: Reimbursement hurdles (gatekeepers) largely cleared for 90%+ of patients; NCCN guidelines (anticipated this quarter) expected to drive clarity and insurer uptake.
  • Testing Rates: Management disputes speculative literature suggesting ESR1 mutation rates could rise to 50% via ctDNA; maintains current trial-based incidence is ~40% as "best case" detection scenario.
• Therapeutic Preference: Physicians prefer endocrine backbone therapies over chemotherapy/ADCs where credible opportunity exists; RevTropic regimen fits this paradigm.

Macro / Industry Outlook:

• J-Code Reimbursement: Temporary J-code usage will create friction and limit potential population treated until April 1st (expiration/transition of code); some infusion centers may delay availability until new code is established.
• Supply Chain: Direct-to-infusion center model (drop-shipping) reduces distribution steps but limits data granularity available to the company; relies on site-level order data.

Strategic Initiatives:

• Manufacturing Expansion:
  • Primary goal: Build redundancy and capacity.
  • 2027: Multiple capacity initiatives; new second supplier online.
  • 2028: Additional capacity required to support demand.
  • Europe: Third manufacturer in process to support European supply and scheduling flexibility.
• Guideline Engagement: Expecting NCCN manuscript release this quarter to support inclusion in treatment guidelines.
• Phase 3 First-Line Trials: Accelerating enrollment to advance toward submission and approval within the next few years.

Risks and Headwinds to Outlook:

• Regulatory Complexity: Submission of doublet indication alongside triplet for PIK3CA mutant data introduces "complex review" status with FDA, risking delay and loss of priority review status.
• Reimbursement Friction: Delays in new J-code establishment or hesitation by infusion centers to hold inventory/protocols could slow early adoption.
• Sales Data Granularity: Direct distribution model limits visibility into specific sales metrics (e.g., vial counts per site) compared to specialty pharmacy channels; future reporting will be subject to consistency and interpretability constraints.
• Competition: ESR1 mutant segment remains a more competitive area against established doublet therapies; success relies on proving superiority in that specific cohort.
• Execution Risk: Successful prosecution of first-line and prostate indications depends on completing Phase 3 and Phase 2 studies on schedule (2027) and obtaining definitive data.

Management Tone on the Future:

• Confidence Level: High. Management uses terms like "unprecedented data," "very favorable," "high probability of success," and "robustness to the opportunity."
• Outlook Sentiment: Optimistic regarding the potential for a "multibillion-dollar drug" and the significance of the first-line indication as one of the "most valuable indications in oncology."
• Cautionary Notes: Willing to accept regular review timelines if it allows for dual-indication approval; careful not to promote off-label or "hoops-jumping" by physicians; acknowledges data variability in smaller subgroups (e.g., doublet analysis).

Miscellaneous:

• Data Disclosure: Manuscript supporting PIK3CA mutant data expected to be published this quarter.
• Analyst Interaction: Company will provide "thoughtful" metrics to investors but will avoid sharing data that results in multiple interpretations.