– Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with topline data expected for Advance-HTN trial in Q4 2024 and Launch-HTN trial in 2H 2025 –
– Explore-CKD Phase 2 trial, a study for lorundrostat in hypertensive patients with stage 2-3b CKD on track for Q4 2024 to Q1 2025 topline data –
– Conference call today at
“Throughout 2023 we accomplished key milestones that put us in a position to execute our pivotal development plan for lorundrostat for the treatment of hypertension, as well as adjacent conditions including chronic kidney disease,” stated
Recent Corporate and Clinical Highlights
- Pivotal Launch-HTN Phase 3 Trial – In the fourth quarter of 2023, the Company initiated the Launch-HTN trial, the second ongoing pivotal trial of lorundrostat for the treatment of patients with uHTN or rHTN, when added to subjects’ existing background hypertension treatment.
- Pivotal Advance-HTN Trial – The first of the two ongoing pivotal trials, the Advance-HTN trial is evaluating the safety and efficacy of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to an AHA guidelines-based standardized background treatment regimen of either two or three antihypertensive medications.
- Open-Label Extension Trial – In mid-2023, the Company initiated an open-label extension trial to allow subjects to continue to receive lorundrostat and obtain additional safety and efficacy data.
- BMI Data from Target-HTN Phase 2 Trial – The Company presented data from a new analysis of serum leptin levels among subjects in the Target-HTN Phase 2 trial, which showed that increased BMI was correlated with both increased leptin and increased aldosterone production. These data expand our understanding of mechanisms that may link the increasing prevalence of obesity to a parallel increase in uncontrolled and resistant hypertension. These data were presented at the
American Heart Association (AHA) Scientific Sessions in Q4 2023. - Expanded Management Team – Appointed
Minji Kim , Ph.D. as Chief Business Officer.Dr. Kim brings more than two decades of experience in business development, strategic leadership, and scientific research. During her career, she has worked with biotech companies in theU.S. and overseas across broad therapeutic and technical areas. - Strengthened Balance Sheet – Subsequent to the end of the fourth quarter, the Company completed a private placement financing for gross proceeds of approximately
$120 million , before deducting fees and expenses.
Key Upcoming Milestones
- Pivotal Advance-HTN Trial – Enrollment in the study is on track to announce topline data in the fourth quarter of 2024.
- Phase 3 pivotal Launch-HTN Trial – Topline data from this trial is expected in the second half of 2025.
- Explore-CKD Phase 2 Trial – The trial design is being modified, including allowing all subjects to use concurrent SGLT2 inhibitors, which have become the standard of care in CKD, and reducing the eGFR cutoff to 30ml/min/1.73m2 for all trial participants, obviating the need for Part B of the trial. The trial remains on track to report topline data in the fourth quarter of 2024 to the first quarter of 2025.
Fourth Quarter and Annual 2023 Financial Highlights
Cash, cash equivalents and investments were
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
Total other income, net was
Net loss was
Conference Call
The Company’s management team will host a conference call at
About Hypertension
Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the
Less than 50 percent of hypertension patients achieve their blood pressure goal with currently available medications. Abnormally elevated aldosterone levels are a key factor in driving hypertension in approximately 25 percent of all hypertensive patients.
About Chronic Kidney Disease (CKD)
CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension and CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects.
In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uncontrolled hypertension, in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia.
About Mineralys
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD and other diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and CKD. Mineralys is based in
Forward Looking Statements
Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that the Advance-HTN and the planned Phase 3 clinical trial of lorundrostat may serve as pivotal trials in any submission of a new drug application (NDA) to the
Contact:
Investor Relations
investorrelations@mineralystx.com
Media Relations
Elixir Health Public Relations
Phone: (1) 515-707-9678
Email: tweible@elixirhealthpr.com
Condensed Statements of Operations (in thousands, except share and per share data) (unaudited) | |||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 23,685 | $ | 7,818 | $ | 70,361 | $ | 26,250 | |||||||
General and administrative | 4,026 | 2,190 | 14,296 | 5,229 | |||||||||||
Total operating expenses | 27,711 | 10,008 | 84,657 | 31,479 | |||||||||||
Loss from operations | (27,711 | ) | (10,008 | ) | (84,657 | ) | (31,479 | ) | |||||||
Interest income, net | 3,321 | 935 | 12,756 | 1,676 | |||||||||||
Other income | 1 | — | 3 | 4 | |||||||||||
Total other income, net | 3,322 | 935 | 12,759 | 1,680 | |||||||||||
Net loss | $ | (24,389 | ) | $ | (9,073 | ) | $ | (71,898 | ) | $ | (29,799 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.61 | ) | $ | (1.74 | ) | $ | (1.99 | ) | $ | (5.77 | ) | |||
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted | 40,093,242 | 5,210,456 | 36,188,254 | 5,167,296 |
Selected Financial Information Condensed Balance Sheet Data (amounts in thousands) (unaudited) | ||||||
2023 | 2022 | |||||
Cash, cash equivalents and investments | $ | 239,049 | $ | 110,110 | ||
Total assets | $ | 251,636 | $ | 114,442 | ||
Total liabilities | $ | 10,482 | $ | 8,067 | ||
Total stockholders’ equity (deficit) | $ | 241,154 | $ | (52,269 | ) |
Source:
2024 GlobeNewswire, Inc., source