Mineralys Therapeutics (MLYS) Q2 2024 earnings summary

Executive summary

• Significant progress in lorundrostat clinical programs, with pivotal Advance-HTN and Launch-HTN trials for hypertension and a proof-of-concept Explore-CKD trial for CKD underway; all are well-funded and advancing enrollment.

• Advance-HTN trial is approximately 90% enrolled, with topline data expected in Q1 2025; Launch-HTN enrollment is ahead of schedule, with topline data anticipated in H2 2025.

• Explore-CKD trial protocol amendment improved enrollment, with topline data expected in H1 2025.

• No products approved or revenue generated; operations to date have centered on R&D, clinical trials, and capital raising.

Financial highlights

• Cash, cash equivalents, and investments totaled $311.1 million as of June 30, 2024, up from $239 million at year-end 2023.

• R&D expenses rose to $39.3 million in Q2 2024 from $11.9 million in Q2 2023, driven by clinical trial activity and increased headcount.

• G&A expenses increased to $5.9 million in Q2 2024 from $3.9 million in Q2 2023, mainly due to higher compensation and professional fees.

• Net loss was $41.0 million for Q2 2024, compared to $12.1 million for Q2 2023.

• Private placement in February 2024 raised $116.1 million; no ATM shares sold as of June 30, 2024.

Outlook and guidance

• Cash position is expected to fund planned clinical trials and operations into 2026.

• Advance-HTN topline data expected in Q1 2025; Launch-HTN topline data in H2 2025; Explore-CKD topline data in H1 2025.

• Anticipates continued substantial operating losses as clinical development progresses; no product revenue expected for several years.