RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced financial results for the quarter ending March 31, 2023, and provided a corporate update.
“This year is off to a strong start as we continued to build momentum developing lorundrostat for the targeted treatment of hypertension. Most recently we started dosing patients in our confirmatory pivotal Advance-HTN trial evaluating the safety and efficacy of lorundrostat for the treatment of uncontrolled or resistant hypertension. We expect this trial to readout topline data in the first half of 2024,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “In addition, we plan to initiate a second lorundrostat pivotal trial named Launch-HTN in the second half of 2023, which is expected to readout topline data in mid-2025. We believe our current cash, cash equivalents and investments will fund our planned clinical studies and support our operations through mid-2025.”
Recent Corporate and Clinical Highlights
- Initiated pivotal Advance-HTN trial – In April 2023, the Company initiated patient dosing in the Advance-HTN Phase 2 trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to standardized background treatment of two or three antihypertensive medications in up to approximately 300 adult subjects. The topline data from this trial is expected in the first half of 2024.
- Target-HTN trial presented at ACC.23/WCC – In March 2023, the Company presented positive data from the Target-HTN Phase 2 trial that demonstrated a clinically meaningful reduction in blood pressure. The presented data included a pre-specified analysis of lorundrostat treatment in hypertensive subjects with a body mass index (BMI) ≥30 kg/m2 (obese) that demonstrated statistically significant reduction in placebo-adjusted systolic blood pressure that was larger than that observed in the group as a whole or the subset of subjects with BMI <30kg/m2.
In addition to the Company’s presentation of results in hypertensive individuals, Mineralys also reported full Phase 1 healthy volunteer safety, PK and PK/PD results at the ACC.23/WCC meeting. This study, conducted by Mitsubishi Tanabe Pharma, characterized single and multiple ascending doses of lorundrostat in subjects for up to 7 days of treatment with a dose exceeding the anticipated clinical dose by 3.5- to 7-fold. As with the Target-HTN trial, lorundrostat was well-tolerated and had the predicted effect of suppressing aldosterone in a dose-dependent fashion without inhibiting cortisol.
Key Upcoming Milestones
- CKD profiling trial – In mid-2023, the Company plans to initiate a randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN or rHTN in a chronic kidney disease (CKD) population. Topline data from this trial is expected in the first half of 2024.
- Phase 3 pivotal Launch-HTN trial – In the second half of 2023, the Company plans to initiate a randomized, double-blind, placebo-controlled Phase 3 trial to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to prescribed background treatment of two or more antihypertensive medications in up to approximately 1,000 adult subjects. The topline data from this trial is expected in mid-2025.
- Open-label extension trial for long-term safety exposure – In mid-2023, the Company plans to initiate an open-label extension trial to obtain additional safety data – all subjects in the pivotal hypertension program, including the Advance-HTN and Launch-HTN trials will be given the opportunity to participate.
First Quarter 2023 Financial Highlights
Research and Development (R&D) expenses were $12.3 million for the quarter ended March 31, 2023, compared to $6.8 million for the quarter ended March 31, 2022. The increase in R&D expenses was primarily due to increases in the 2023 period of $4.0 million in license fees under a license agreement with Mitsubishi Tanabe Pharma upon achieving a development milestone of lorundrostat in March 2023, $0.9 million in higher compensation expense as a result of additions to headcount, $0.7 million in clinical supply, manufacturing and regulatory costs and $0.5 million in other research and development expenses, partially offset by a decrease of $0.6 million in preclinical and clinical costs, driven by the timing of research and development activities and clinical trials of lorundrostat in each quarter.
General and Administrative (G&A) expenses were $2.6 million for the quarter ended March 31, 2023, compared to $0.8 million for the quarter ended March 31, 2022. The increase in G&A expenses was primarily due to $0.8 million in higher compensation expense as a result of additions to headcount, $0.5 million in higher professional fees associated with operating as a public company, $0.4 million in higher other administrative expenses and $0.2 million associated with new director and officer insurance policies.
Net loss was $12.6 million for the quarter ended March 31, 2023, compared to $7.6 million for the quarter ended March 31, 2022. The increase was primarily attributable to the factors impacting the Company’s expenses described above.
Cash, cash equivalents and investments were $301.8 million as of March 31, 2023, compared to $110.1 million as of December 31, 2022. The Company believes that its cash, cash equivalents and investments as of March 31, 2023 will be sufficient to allow the Company to fund the planned clinical studies, as well as support corporate operations through mid-2025.
For more information, visit https://mineralystx.com.
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