CELC Q2 2026 Earnings Call Summary

1Key Financial Results and Metrics

Net Loss: $78.9 million ($1.44 per share) compared to $45.3 million ($1.04 per share) in Q2 2025.

Non-GAAP Adjusted Net Loss: $58.7 million ($1.07 per share) versus $40.5 million ($0.93 per share) in the prior year.

R&D Expenses: $31.1 million, down from $36.4 million year-over-year, primarily due to decreased clinical trial costs.

SG&A Expenses: $35 million, significantly up from $7.6 million, driven by increased personnel costs for the commercial launch of Revtopik.

Cash Position: $754 million as of June 30, 2026, up from $441.5 million at the end of 2025, bolstered by a $575 million convertible note offering.

Net Cash Used in Operating Activities: $55.4 million, an increase from $36.2 million in the prior year.

2Strategic Updates and Business Highlights

FDA Approval: Revtopik approved for HR positive, HER2 negative advanced breast cancer, with shipments expected to begin in late Q3 2026.

Clinical Development: Positive results from the VIKTORIA-1 study for gedatolisib, showing significant improvement in progression-free survival (PFS) compared to alpelisib.

Expanded Clinical Trials: VICTORIA-2 trial expanded to include treatment-naive patients, aiming to position gedatolisib as a first-line treatment option.

Commercial Launch Preparations: Infrastructure for Revtopik's launch is complete, with 80 oncology sales specialists engaged in outreach and education.

3Forward Guidance and Outlook

Market Potential: Estimated total addressable market for Revtopik exceeds $6 billion annually, targeting approximately 37,000 patients in the U.S.

Future Submissions: Plans to submit a supplemental NDA for the PIK3CA mutant cohort in Q3 2026, with expectations for regulatory feedback within 2-4 months post-submission.

Cash Runway: Current cash reserves expected to support operations into 2029.

4Bad News, Challenges, or Points of Concern

Increased Losses: The net loss has widened significantly compared to the previous year, raising concerns about the sustainability of current spending levels.

High SG&A Costs: Substantial increase in SG&A expenses indicates heavy investment in commercial operations, which may pressure future profitability.

Regulatory Risks: Dependence on timely FDA approvals for new manufacturing sites and supplemental filings poses potential delays in product availability.

Market Competition: The need to differentiate gedatolisib from competitors, particularly in the context of emerging therapies in similar indications.

5Notable Q&A Insights

Confidence in Launch: Management expressed confidence in the ability to begin shipments of Revtopik by late Q3, contingent on FDA review processes.

Expanded Access Program: The program is operational, with initial shipments underway, but specifics on patient enrollment and updates were not committed to a regular schedule.

Gross to Net Expectations: Anticipated gross-to-net discount for Revtopik is about 20%, which is favorable compared to typical oral therapies.

Prostate Cancer Development: Upcoming data in Q4 2026 is expected to include PSA response and progression-free survival metrics, with a focus on demonstrating superiority over existing treatments. This summary encapsulates the key financial metrics, strategic initiatives, forward guidance, challenges, and insights from the Q&A session, providing a balanced view of Celcuity's current standing and future prospects.