Mineralys Therapeutics (MLYS) Q3 2024 earnings summary

Executive summary

• Completed enrollment in pivotal Advance-HTN and Launch-HTN trials for lorundrostat in uncontrolled or resistant hypertension, with topline data expected in the first half of 2025.

• Ongoing Explore-CKD Phase II trial in patients with hypertension and stage 2-3B chronic kidney disease, with topline data expected in Q2 2025.

• Lorundrostat targets significant unmet needs in hypertension and CKD, with diverse patient populations enrolled in trials.

• No products are approved or revenue generated; operations funded by $498.8M raised to date.

• All clinical and financial activities are focused on lorundrostat development for cardiorenal conditions.

Financial highlights

• Cash, cash equivalents, and investments totaled $263.6 million as of September 30, 2024, up from $239 million at year-end 2023.

• R&D expenses for Q3 2024 were $54 million, up from $22.5 million in Q3 2023, mainly due to increased clinical activity.

• G&A expenses rose to $6.1 million for Q3 2024 from $3.8 million year-over-year, driven by higher compensation and professional fees.

• Net loss for Q3 2024 was $56.3 million, compared to $22.8 million in Q3 2023.

• Net loss for the nine months ended September 30, 2024 was $128.9 million, up from $47.5 million year-over-year.

Outlook and guidance

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

• Advance-HTN topline data anticipated in March 2025; Launch-HTN data expected mid-first half 2025; Explore-CKD data in Q2 2025.

• No revenue expected until after regulatory approval, which is not anticipated for several years.