Mineralys Therapeutics Inc (MLYS) Reports Increased R&D Expenses Amid Progress in ...
Research and Development Expenses: Increased to $70.4 million for the year, reflecting investment in pivotal clinical trials.
General and Administrative Expenses: Rose to $14.3 million annually due to the costs of operating as a public company and staff expansion.
Net Loss: Grew to $71.9 million for the year, driven by higher R&D and G&A expenses.
Cash Position: Strengthened with $239.0 million in cash, cash equivalents, and investments as of December 31, 2023.
Upcoming Milestones: Topline data from Advance-HTN and Launch-HTN trials expected in Q4 2024 and 2H 2025, respectively.
On March 21, 2024, Mineralys Therapeutics Inc (NASDAQ:MLYS) released its 8-K filing, detailing its financial results for the fourth quarter and the full year ending December 31, 2023, and provided an update on its corporate activities. Mineralys Therapeutics, a clinical-stage biopharmaceutical company, is dedicated to developing treatments for diseases associated with elevated aldosterone levels, such as hypertension and chronic kidney disease (CKD).
The company's lead product candidate, lorundrostat, is an orally administered, selective aldosterone synthase inhibitor, currently undergoing pivotal trials for the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).
Financial Performance and Clinical Progress
Mineralys Therapeutics reported a significant increase in research and development (R&D) expenses, which totaled $70.4 million for the year ended December 31, 2023, compared to $26.3 million for the previous year. The increase was primarily due to the initiation of the lorundrostat pivotal program and associated clinical costs. General and administrative (G&A) expenses also rose to $14.3 million for the year, up from $5.2 million in the prior year, reflecting the costs associated with operating as a public company and increased headcount.
The company's net loss widened to $71.9 million for the year, from $29.8 million in the previous year, largely due to the increased investment in R&D activities. Despite the higher net loss, Mineralys strengthened its balance sheet with cash, cash equivalents, and investments totaling $239.0 million as of December 31, 2023, an increase from $110.1 million at the end of 2022. This financial position is expected to support the company's planned clinical studies and corporate operations into 2026.
Key Clinical Milestones and Future Outlook
Mineralys Therapeutics has achieved several important milestones, including the initiation of the Launch-HTN trial, the second pivotal trial of lorundrostat. The company also began an open-label extension trial to collect additional safety and efficacy data. Furthermore, new data presented at the American Heart Association Scientific Sessions in Q4 2023 linked increased body mass index (BMI) with higher aldosterone production, highlighting the potential impact of lorundrostat on cardiorenal metabolic conditions.
Looking ahead, Mineralys anticipates topline data from the Advance-HTN trial in Q4 2024 and from the Launch-HTN trial in the second half of 2025. The Explore-CKD Phase 2 trial is also on track, with topline data expected between Q4 2024 and Q1 2025.
The company's efforts are underscored by the significant unmet medical need in hypertension and CKD, with less than 50% of hypertension patients achieving their blood pressure goals with current medications, and CKD being a leading cause of mortality worldwide.
Mineralys Therapeutics' focus on developing lorundrostat for conditions affected by elevated aldosterone, including hypertension and CKD, positions it at the forefront of addressing these widespread health concerns. The company's progress and financial results reflect its commitment to advancing its clinical programs and potentially delivering new treatment options to patients.
For more detailed information on Mineralys Therapeutics' financial results and clinical updates, interested parties are invited to join the company's conference call or access the webcast through the provided link.
Investors and stakeholders are encouraged to follow Mineralys Therapeutics for further updates and to visit mineralystx.com for more information on the company's mission and pipeline.
Explore the complete 8-K earnings release (here) from Mineralys Therapeutics Inc for further details.
This article first appeared on GuruFocus.
