Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
Rhea-AI Summary
Mineralys Therapeutics (Nasdaq: MLYS) reported second quarter 2026 results and progress on lorundrostat, its aldosterone synthase inhibitor for hypertension. The FDA is reviewing the lorundrostat NDA with a PDUFA target date of December 22, 2026, and the company is advancing commercial launch preparations.
Mineralys appointed cardiovascular specialist James J. “Terry” Ferguson III, M.D. as Chief Medical Officer, effective August 10, 2026, while former CMO David Rodman becomes a full-time Strategic Advisor. The company strengthened lorundrostat economics by amending its Tanabe license, eliminating royalties in exchange for a $200 million upfront payment and up to $255 million in commercial milestones plus up to $10 million tied to a potential second indication.
Second quarter 2026 cash, cash equivalents and investments totaled $661.4 million, and Mineralys believes this will fund planned operations, including a potential launch, into 2028. Quarterly R&D expenses rose to $221.4 million, largely due to the Tanabe payment, G&A expenses were $24.7 million, and net loss was $241.1 million or $(2.85) per share.
Positive
- Cash, cash equivalents and investments of $661.4 million as of June 30, 2026
- Belief that existing capital will fund planned operations, including lorundrostat launch, into 2028
- Completed follow-on offering of 5,660,378 shares, raising approximately $150 million in gross proceeds
- Secured term loan facility of up to $500 million, with $100 million drawn in June 2026
- Eliminated lorundrostat royalties to Tanabe via $200 million upfront and up to $255 million milestones
- FDA lorundrostat NDA under review with December 22, 2026 PDUFA target date
Negative
- Quarterly R&D expenses rose to $221.4 million from $38.3 million year over year
- G&A expenses increased to $24.7 million from $8.5 million for the prior-year quarter
- Second quarter 2026 net loss widened to $241.1 million from $43.3 million
- Assumed Tanabe commercial milestone obligations up to $255 million plus up to $10 million for a second indication
- Recorded senior secured term loan balance of $97.6 million, increasing total liabilities to $116.9 million
News Explained
New shares reduce existing holders’ percentage ownership, while only $100.0 million of a possible $500.0 million secured facility was drawn.
During the second quarter, Mineralys Therapeutics completed a follow-on offering of
The new shares increase the total share count and, absent offsetting changes, reduce each existing holder’s percentage ownership; the term loan adds secured borrowing to the company’s financing structure.
The disclosed financing state is therefore a completed equity issuance plus a partially drawn debt facility:
Market reaction after 2Q26 earnings report: MLYS -4.87%
Following this news, MLYS has declined 4.87%, reflecting a moderate negative market reaction. The stock is currently trading at $26.00.
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Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 06 | Q1 earnings | Positive | -2.6% | NDA acceptance and continued funding runway accompanied quarterly financial results. |
| Mar 12 | Q4 earnings | Positive | -3.0% | NDA acceptance and clinical progress were reported alongside full-year financial results. |
| Nov 10 | Q3 earnings | Positive | +5.9% | NDA planning, clinical enrollment, financing and cash runway updates accompanied quarterly results. |
| Aug 12 | Q2 earnings | Positive | +0.4% | Positive clinical trial results and additional CKD data accompanied quarterly financial results. |
| May 12 | Q1 earnings | Positive | +1.2% | Pivotal trial outcomes and public equity financing accompanied quarterly financial results. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings-tagged history showed both positive and negative reactions, including declines after the two most recent prior earnings updates.
Key Terms
pdufa regulatory
new drug application regulatory
open-label extension trial medical
aldosterone synthase inhibitor medical
cyp11b2 technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval –
– Appoints accomplished cardiovascular medicine executive Dr. Terry Ferguson as Chief Medical Officer to lead the Company’s medical and late-stage clinical activities –
– Strengthened balance sheet and enhanced the long-term economics of lorundrostat through strategic financing initiatives and the repurchase of the Tanabe royalty obligation –
– Conference call today at 4:30 p.m. ET –
RADNOR, Pa., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.
“Mineralys is advancing toward an exciting next chapter as we prepare for the commercial launch of lorundrostat, pending FDA approval. The efficacy and safety profile of lorundrostat supports its potential as a compelling treatment option for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys. "We are also excited to welcome Terry Ferguson as our new Chief Medical Officer. His extensive experience in cardiovascular medicine strongly positions him to lead our medical organization. David Rodman, who guided the development of lorundrostat from proof of concept through the pivotal program, as well as our recent new drug application filing with the FDA, will continue to contribute to Mineralys in his full-time role as a Strategic Advisor."
“I am very pleased to join the team at Mineralys in advance of the December PDUFA target date,” said Dr. Terry Ferguson, Chief Medical Officer of Mineralys. “Uncontrolled or resistant hypertension is a major driver of cardiovascular morbidity and mortality and a continuing issue for millions of Americans. I look forward to helping bring new treatment options, like lorundrostat, to patients with hypertension and other conditions where modulating dysregulated aldosterone may provide significant benefit.”
Recent Highlights and Upcoming Milestones
- Lorundrostat New Drug Application (NDA) — The U.S. Food and Drug Administration (FDA) continues its review of the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.
- Appointment of New Chief Medical Officer (CMO) — Appointed James J. "Terry" Ferguson III, M.D., as CMO, effective August 10, 2026, succeeding David Rodman, M.D., who will stay on with the Company as a full-time Strategic Advisor. Terry brings more than 35 years of experience in cardiovascular medicine and drug development, including serving as Cardiovascular Therapeutic Area Head at Amgen, nearly a decade in cardiovascular leadership roles at AstraZeneca and The Medicines Company, as well as more than two decades on the faculty of the Texas Heart Institute. Most recently, he served as Chief Medical Officer at Cadrenal Therapeutics. In his new role, Terry will lead Mineralys' medical and late-stage clinical activities.
- Transform-HTN Open-Label Extension Trial — The Company’s ongoing Transform-HTN open-label extension trial, which supported the NDA submission, continues to enable participants to receive lorundrostat and generate additional long-term safety and efficacy data.
- Commercial Launch Readiness — The Company continues to advance commercial launch preparations ahead of lorundrostat’s PDUFA target date of December 22, 2026 and remains on track. An experienced commercial leadership team is now in place, initial sales territories and priority geographies have been identified, and engagement continues with leading hypertension experts and payers covering a substantial majority of U.S. lives. The Company expects to have the sales organization established in advance of the anticipated PDUFA target date.
- Strengthened Balance Sheet and Lorundrostat Economics — During the second quarter of 2026, Mineralys strengthened its financial position and enhanced the long-term economics of lorundrostat through the following transactions:
- Completed a follow-on public offering of 5,660,378 shares of common stock, generating gross proceeds of approximately
$150.0 million . - Entered into a senior secured term loan facility for up to
$500.0 million from funds managed by Pharmakon Advisors, LP, including an initial$100.0 million tranche drawn in June 2026. - Amended the Tanabe license agreement to eliminate the Company’s royalty obligations, strengthening the Company’s economic rights to lorundrostat. The Company made an upfront cash payment to Tanabe of
$200.0 million and agreed to pay additional commercial milestone payments of up to$100.0 million in the aggregate (the New Milestones). As a result, the Company has remaining obligations to pay Tanabe commercial milestone payments, including the New Milestones, of up to$255.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as up to$10.0 million related to commercialization for a potential second indication. Tanabe has also agreed to subsequently assign to Mineralys all of Tanabe’s rights in the licensed intellectual property.
- Completed a follow-on public offering of 5,660,378 shares of common stock, generating gross proceeds of approximately
Second Quarter 2026 Financial Highlights
Cash, cash equivalents and investments were
Research and development (R&D) expenses for the quarter ended June 30, 2026 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 4:30 p.m. ET today, August 11, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States, referencing conference ID 13760792. 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 Investors section of the Mineralys website here.
About Lorundrostat
Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. 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, has an observed half-life of 10-12 hours and demonstrated a 40
Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.
About Mineralys
Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, X and Bluesky.
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 Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding: the anticipated timing of the FDA's review of Mineralys’ accepted NDA and any subsequent regulatory approval of lorundrostat; the potential therapeutic benefits of lorundrostat; Mineralys’ expectations regarding activities to prepare for the commercial launch of lorundrostat; the capital available under Mineralys’ secured debt facility, including the potential to draw down additional tranches thereunder; Mineralys’ expectations with respect to finalizing an agreement with Tanabe to terminate the license agreement and to have Tanabe’s rights in the licensed intellectual property transferred to Mineralys; and the sufficiency of Mineralys’ cash, cash equivalents and investments to fund its operations. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the FDA’s review of Mineralys’ accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ 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; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in its 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 Mineralys undertakes 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
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
| Mineralys Therapeutics, Inc. Condensed Statements of Operations (in thousands, except share and per share data) (unaudited) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 221,377 | $ | 38,278 | $ | 245,742 | $ | 76,157 | |||||||
| General and administrative | 24,663 | 8,468 | 45,638 | 15,036 | |||||||||||
| Total operating expenses | 246,040 | 46,746 | 291,380 | 91,193 | |||||||||||
| Loss from operations | (246,040 | ) | (46,746 | ) | (291,380 | ) | (91,193 | ) | |||||||
| Interest income, net | 4,956 | 3,474 | 10,952 | 5,713 | |||||||||||
| Other income (expense) | 13 | (2 | ) | 18 | (5 | ) | |||||||||
| Total other income, net | 4,969 | 3,472 | 10,970 | 5,708 | |||||||||||
| Net loss | $ | (241,071 | ) | $ | (43,274 | ) | $ | (280,410 | ) | $ | (85,485 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.85 | ) | $ | (0.66 | ) | $ | (3.35 | ) | $ | (1.44 | ) | |||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 84,727,282 | 65,451,297 | 83,786,245 | 59,341,368 | |||||||||||
| Mineralys Therapeutics, Inc. Selected Financial Information Condensed Balance Sheet Data (in thousands) (unaudited) | |||||
| June 30, | December 31, | ||||
| 2026 | 2025 | ||||
| Cash, cash equivalents and investments | $ | 661,412 | $ | 656,635 | |
| Total assets | $ | 667,853 | $ | 661,806 | |
| Senior secured term loan, net | $ | 97,617 | $ | — | |
| Total liabilities | $ | 116,936 | $ | 15,113 | |
| Total stockholders’ equity | $ | 550,917 | $ | 646,693 | |
