Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
- None.
- Significant increase in research and development expenses
- Net loss of $71.9 million for the year ended December 31, 2023
Insights
The announcement by Mineralys Therapeutics regarding their clinical trials and financial results is a significant piece of information for investors and stakeholders. The company's commitment to the development of lorundrostat, particularly for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) and chronic kidney disease (CKD), addresses a substantial market need given the prevalence of these conditions. The on-track progress of the pivotal trials and the expected data release in Q4 2024 and 2H 2025 could potentially lead to a surge in investor confidence if the results are positive, impacting the company's stock price favorably.
However, the substantial increase in research and development expenses, from $26.3 million to $70.4 million year-over-year, reflects the company's aggressive investment in its clinical programs. While this is common in the biopharmaceutical industry during the development phase, it does raise the burn rate and could impact financial stability if not managed carefully. The private placement financing of approximately $120 million, which strengthens the balance sheet, is a proactive move to mitigate this risk and extend the company's cash runway into 2026. This financial cushion is critical for the company to reach key milestones without the immediate need for additional capital raising, which could dilute existing shareholders.
The strategic focus on targeting aldosterone for the treatment of cardiorenal metabolic conditions is noteworthy. Aldosterone has been implicated in various cardiovascular and renal diseases and the development of lorundrostat could represent a significant advancement in the treatment options available for patients with uHTN, rHTN and CKD. The modification of the Explore-CKD Phase 2 trial design to include SGLT2 inhibitors, which are now standard care in CKD, demonstrates Mineralys Therapeutics' commitment to current clinical practice and could enhance the trial's relevance and potential for positive outcomes.
The relationship between obesity, leptin and aldosterone production, as presented in the Target-HTN Phase 2 trial data, is an interesting development that could have broader implications for understanding and treating hypertension. If lorundrostat proves to be effective, it might not only serve a significant patient population but also pave the way for further research into the cardiometabolic effects of aldosterone and its role in obesity-related hypertension.
From a market perspective, Mineralys Therapeutics is positioning itself in a competitive landscape where innovation in hypertension and CKD treatments is highly valued. The hypertension market is crowded with generic drugs and new treatments must demonstrate clear benefits over existing therapies. Lorundrostat's potential to fill an unmet need in uHTN and rHTN, conditions that are often difficult to manage with current treatments, could give the company a significant competitive edge. Moreover, the expansion of the management team with experienced professionals like Dr. Minji Kim suggests a strategic approach to business development and scientific research, which is critical for navigating the complex biotech industry.
Investors should keep an eye on the company's ability to maintain its development timeline and manage its cash burn rate. Delays in clinical trials or unfavorable trial results could negatively impact market sentiment and the company's valuation. Conversely, positive trial outcomes could lead to partnerships or acquisition interest from larger pharmaceutical companies, potentially driving up the stock price.
– 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 8:30 a.m. ET –
RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update.
“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 Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “In 2024, we are working towards achieving several clinical events, which we expect to expand the data package for lorundrostat. We believe aldosterone, like obesity, is a significant driver of cardiorenal metabolic conditions and our pursuit of developing an aldosterone targeted approach has the potential to impact millions of patients impacted by these conditions.”
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 the U.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 8:30 a.m. ET on Thursday, March 21, 2024. To access the call, please dial 1-888-886-7786 in the U.S. or 1-416-764-8658 outside the U.S., followed by the conference ID: 27947513. A live webcast of the conference call may be found here. A replay of the call will be available on the “News & Events” page in the Investor Relations section of the Mineralys Therapeutics website.
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 U.S. In 2020, more than 670,000 deaths in the U.S. included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an average annual economic burden of about
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
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
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 Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter.
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 United States Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD or uncontrolled hypertension; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Investor Relations
investorrelations@mineralystx.com
Media Relations
Tom Weible
Elixir Health Public Relations
Phone: (1) 515-707-9678
Email: tweible@elixirhealthpr.com
| Mineralys Therapeutics, Inc. Condensed Statements of Operations (in thousands, except share and per share data) (unaudited) | |||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 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 | |||||||||||
| Mineralys Therapeutics, Inc. Selected Financial Information Condensed Balance Sheet Data (amounts in thousands) (unaudited) | ||||||
| December 31, | ||||||
| 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 | ) | |
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