Mineralys Therapeutics, Inc. reported a net loss of $177.8 million for the year ended December 31, 2024, compared to a net loss of $71.9 million in 2023. Research and development expenses increased by $98.2 million, primarily due to the initiation of the lorundrostat pivotal program in the second quarter of 2023 and increased personnel costs. General and administrative expenses rose by $9.5 million, mainly due to higher compensation expenses and professional fees. The company's total other income, net, increased by $1.8 million, primarily due to higher interest earned on investments.
As of December 31, 2024, Mineralys held $198.2 million in cash, cash equivalents, and investments. The company's cash flow from operating activities was a negative $166.3 million in 2024, compared to a negative $81.2 million in 2023. Net cash provided by investing activities was $115.0 million in 2024, a significant increase from the negative $160.5 million in 2023, primarily due to the timing of marketable securities maturities. Net cash provided by financing activities decreased to $116.1 million in 2024 from $203.2 million in 2023, reflecting the completion of the IPO in 2023.
Significant developments during the year included the completion of enrollment in three pivotal clinical trials for lorundrostat: Advance-HTN (Phase 2), Launch-HTN (Phase 3), and Explore-CKD (crossover trial). Topline data from these trials are anticipated in March 2025, mid-first half of 2025, and the second quarter of 2025, respectively. An open-label extension trial, Transform-HTN, is ongoing. Additionally, the FDA cleared the IND for Explore-OSA, a Phase 2 trial for lorundrostat in patients with obstructive sleep apnea and hypertension, anticipated to begin in the first quarter of 2025. The company also completed a private placement offering in February 2024, raising net proceeds of approximately $116.1 million.
Mineralys Therapeutics currently has 51 full-time employees, 39 of whom are in research and development. The company does not own manufacturing facilities and relies on third-party contract manufacturers. The company's commercial strategy for lorundrostat, if approved, remains undefined, pending further evaluation as approval nears. The company's financial outlook anticipates continued losses for the foreseeable future, with funding expected to come from equity offerings, debt financings, or other capital sources.
The company's 10-K filing highlights numerous risk factors, including reliance on lorundrostat's success, the inherent uncertainties of clinical trials, dependence on third-party manufacturers and collaborators, potential competition, and the complexities of regulatory approvals and market access. The filing also details the company's intellectual property portfolio, including patents and patent applications, and its compliance with various regulatory requirements.
About Mineralys Therapeutics, Inc.
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