Celcuity Inc. (CELC) Earnings

Management highlights

### Clinical Development Progress - **RevterPIC (gettalizib) for HR-positive HER2-negative advanced breast cancer**: Received FDA approval for use in patients without a detectable PIK3CA mutation who have progressed after at least one line of metastatic endocrine therapy. Received a preferred Category 1 NCCN guideline recommendation for second-line and subsequent treatment. - **Victoria 1 Pivotal Phase 3 Trial**: Positive PIK3CA mutant cohort results presented at ASCO 2026 showed median PFS of 11.1 months (gettalizib triplet) and 11.3 months (gettalizib doublet), both doubling the 5.6 month median PFS of the comparator opalipsib plus fulvestrant, with hazard ratios of 0.5 and 0.51 respectively. Treatment discontinuation due to adverse events was only 5.2% for the triplet and 3.8% for the doublet, compared to 19% for the comparator. Updated analysis shows longer average treatment cycles and higher rates of ongoing treatment than previously reported. - **Regulatory Next Steps**: A supplemental NDA (sNDA) for the PIK3CA mutant indication will be submitted in Q3 2026, with global regulatory submissions to follow. Commercial shipments are on track to begin late Q3 2026. - **Victoria 2 Phase 3 First-Line Trial**: Expanded to add a cohort for treatment-naive endocrine-sensitive HR-positive HER2-negative advanced breast cancer, alongside the ongoing cohort for endocrine-resistant first-line patients. Preliminary Phase 1b data for the triplet regimen shows a median PFS of 48.6 months, compared to a historical 25 months for the current standard of care. - **Prostate Cancer Program**: Phase 1b dose-finding for gettalizib plus darolutamide in metastatic castration-resistant prostate cancer (mCRPC) has completed evaluation of the 240mg dose with no treatment-discontinuing adverse events or dose-limiting toxicities, and is now evaluating the 300mg dose. Updated clinical data and development strategy will be shared in Q4 2026. - **Subcutaneous Formulation**: Development of a subcutaneous gettalizib formulation (to replace the current intravenous formulation) is ongoing, focused on demonstrating clinical equivalence to support long-term treatment use. ### Commercial Launch Preparation - Commercialization infrastructure is fully complete, with commercial activities launched immediately after FDA approval. The 88-person oncology sales specialist team (average 24 years of industry experience) is now active, supporting EHR order set installation and servicing infusion centers/pharmacies. - All payer and strategic account dossiers have been submitted, and formulary inclusion efforts are ongoing. The wholesale acquisition cost (WAC) is set at $10,000 per vial, or $30,000 per treatment cycle. - An expanded access program (EAP) opened last week for eligible patients prior to full commercial launch, with initial shipments already underway. - Estimated total annual addressable market for RevterPIC in the U.S. is over $6 billion, based on 37,000 eligible second-line patients and an average of 10 treatment cycles per patient.

Guidance

- RevterPIC commercial shipments remain on track to begin late in the third quarter of 2026, with no changes to this timeline from prior guidance. - The supplemental NDA for the PIK3CA mutant indication of gettalizib will be submitted in Q3 2026, as previously planned. - Updated clinical data for the mCRPC gettalizib development program will be provided in Q4 2026, alongside additional details on the development strategy. - Cash, cash equivalents, and short-term investments of $754 million as of June 30, 2026 are expected to be sufficient to fund all planned operations into 2029. - Expected gross-to-net discount from WAC pricing is approximately 20%, resulting in an expected 80% gross-to-net retention, which is more favorable than the 30% average discount seen for comparable oral oncology therapies.

Segment performance

CellCuity is a clinical-stage biotech company that has not yet generated commercial product revenue as of Q2 2026. The only financial segment results reported are corporate-level operating expenses: 1) Research and Development (R&D): $31.1 million in Q2 2026, a $5.3 million decrease from $36.4 million in the prior year period, driven by lower clinical trial costs for the Victoria 1 trial and reduced license milestone costs, partially offset by higher employee/consulting and manufacturing expenses. R&D represents 47% of total Q2 2026 operating expenses. 2) Selling, General & Administrative (SG&A): $35 million in Q2 2026, a $27.4 million increase from $7.6 million in the prior year period. 85% of this increase ($23.4 million) is tied to commercial launch preparation for RevterPIC, including hiring of commercial personnel and pre-launch activities. SG&A represents 53% of total Q2 2026 operating expenses. Total operating expenses for Q2 2026 were $66.1 million.

Risks & headwinds

- All forward-looking statements related to regulatory timelines, clinical trial results, and commercial launch performance are subject to inherent risks and uncertainties, and actual outcomes may differ materially from projections. FDA review of the secondary manufacturing site validation data and the sNDA could take longer than currently expected, potentially delaying commercial supply or label expansion. - Clinical trial results for the first-line Victoria 2 trial and mCRPC program are not guaranteed to replicate the positive efficacy and safety outcomes seen in earlier Phase 1b and Victoria 1 cohorts, and may not meet the efficacy bar required for regulatory approval or adoption. - Commercial adoption of RevterPIC depends on successful formulary inclusion by payers, physician acceptance, and patient access, which may not meet management's expectations. Limited real-time granularity of sales data for the intravenous buy-and-bill model may delay visibility into actual adoption rates. - Transition of patients from the expanded access program to commercial supply carries a risk of treatment interruption if not managed properly, though the protocol is designed to mitigate this risk.

Analyst Q&A

• Q: What is your level of confidence that RevterPIC shipments will launch on time in late Q3 2026, and what is the status of the secondary manufacturing site approval? /

  A: Management remains fully confident that shipments will begin as scheduled in late Q3 2026. All required manufacturing validation data for the secondary site was submitted to the FDA immediately after initial approval, and the review process is underway. No FDA inspection is expected for the site, as the existing validation data meets requirements, and management expects the review to be straightforward. The company cannot ship from the secondary site before FDA sign-off, but has sufficient existing supply to support the initial launch.

• Q: What is the company's outlook for developing gettalizib in endometrial cancer, and how do you see the opportunity relative to existing development in this space? /

  A: There is a strong biological rationale for testing gettalizib in endometrial cancer, as PIK3CA pathway mutations are a key driver of the disease in a large cohort of patients, and older preliminary data shows objective responses even with monotherapy. The company will provide an update on its development plans for this indication later in 2026.

• Q: What data can we expect from the prostate cancer program when you provide an update in Q4 2026, and what is the bar for success in this indication? /

  A: The Q4 2026 update will include new, previously unpresented data, likely including PSA 50 response data and updated progression-free survival (PFS) data for subgroups and the 240mg dose (300mg data will not be mature enough to present yet). The minimum bar for success is a 3-4 month improvement in median PFS over current standard of care options, which have a median PFS of 5-6 months. Management expects to be at least comparable to Plavitco (which delivers >10 months median PFS) and hopes to deliver superior efficacy.

• Q: How will the company communicate launch progress to investors, and what metrics will be available? /

  A: The company will report total shipped vial volumes, which are expected to reflect actual demand with very little inventory buildup (most sites will not hold more than one cycle of stock on hand). Unlike oral therapies, the intravenous buy-and-bill model does not provide real-time granular data on prescriber or patient-level usage. Survey data covering 40-50% of patients will be available but will have a 2-3 month lag, so granular adoption data will not be available in real time.