AI Earnings Predictions for Mineralys Therapeutics Inc. (MLYS)

EX-99.1

2 mlys2026q38kex991.htm

EX-99.1

Document

Exhibit 99.1

Mineralys Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update

– Commercialization plans for lorundrostat are on track ahead of PDUFA target date of December 22, 2026 –

– New analyses from the pivotal Launch-HTN trial showed 46% of participants with uncontrolled or resistant hypertension receiving lorundrostat 50 mg achieved the AHA/ACC guideline systolic blood pressure target of <130 mmHg at Week 12 –

– Transform-HTN open-label extension trial data selected for late-breaking presentation at American Heart Association Scientific Sessions 2026 –

– Conference call today at 4:30 p.m. ET –

RADNOR, Pa. — November 4, 2026 — 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 third quarter ended September 30, 2026, and provided a corporate update.

“With approximately 20 million adults in the U.S. living with uncontrolled or resistant hypertension, despite treatment, there is a significant need for new treatment options. As we approach the December 22nd PDUFA target date for lorundrostat, our focus is on completing our launch preparations so that we are ready to reach patients quickly, pending approval,” said Jon Congleton, Chief Executive Officer of Mineralys. “We also continue to highlight the data from our clinical trials in meetings with physicians and through presentations at scientific congresses, including our recent updates at AHA-HTN and ASN Kidney Week, and our upcoming presentation at the AHA Scientific Sessions. We continue to receive positive feedback from providers, payers and people living with hypertension, and we look forward to the potential to bring lorundrostat to millions of patients in need.”

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.

•New Launch-HTN and Explore-OSA Data at the American Heart Association Hypertension Scientific Sessions (AHA-HTN) and American Society of Nephrology (ASN) Kidney Week 2026

◦A new analysis of the pivotal Phase 3 Launch-HTN trial showed that at Week 12, 46% of lorundrostat-treated participants (50 mg) achieved the AHA/ACC guideline-recommended office systolic blood pressure (SBP) target of <130 mmHg, with more than two-thirds achieving an SBP reduction of ≥10 mmHg. Participants had uncontrolled or treatment-resistant hypertension despite treatment with two to five antihypertensive therapies.

◦An additional new analysis from Launch-HTN demonstrated that lorundrostat achieved similar blood pressure reductions in participants with and without CKD, with consistent reductions across Stages 1-3 CKD. Lorundrostat also reduced albuminuria by 52% versus placebo, validating similar findings in a prior trial in participants with established CKD.

◦Final results from the Phase 2 Explore-OSA trial in overweight or obese adults with moderate-to-severe OSA and hypertension showed that lorundrostat 50 mg taken once daily in the evening reduced morning SBP by 11.1 mmHg at Week 4 (p<0.0001), compared with a 1.0 mmHg reduction with placebo (p=NS). No measurable change in apnea-hypopnea index was observed. Lorundrostat exhibited a favorable safety and tolerability profile, with no evidence of serious safety events, including hyperkalemia.

•Transform-HTN Open-Label Extension Trial — New long-term efficacy and safety data from the ongoing Transform-HTN open-label extension trial will be featured in a late-breaking presentation at the American Heart Association Scientific Sessions 2026, taking place November 6-9 in Chicago, IL.

•Commercial Launch Readiness — The Company is advancing its commercial launch preparations and now has an expanded medical affairs team and sales force in place. The Company continues to engage with leading hypertension experts and payers. Brand marketing preparations are well underway, and the Company is finalizing a full-service patient support program designed to ease access for physicians, their office staff and patients.

Third Quarter 2026 Financial Highlights

Cash, cash equivalents and investments were $624.7 million as of September 30, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028.

Research and development (R&D) expenses for the quarter ended September 30, 202

mlys-20260805

false000193341400019334142026-08-052026-08-05

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): August 5, 2026

MINERALYS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware001-4161484-1966887

(State or other jurisdiction

of incorporation or organization)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

150 N. Radnor Chester Road, Suite F200

Radnor, PA 19087

(Address of principal executive offices) (Zip Code)

(888) 378-6240

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

MLYS

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 11, 2026, Mineralys Therapeutics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended June 30, 2026 and provided a corporate update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 5, 2026, the Company’s Board of Directors (the Board) appointed James J. Ferguson III, M.D., as the Company’s new Chief Medical Officer, effective August 10, 2026, replacing David Rodman, M.D., who remains with the Company on a full-time basis as a Strategic Advisor. In connection with this transition, the Board also completed a detailed review of Dr. Rodman’s new functions and responsibilities and, based upon such review, determined that he no longer satisfies the definition of “officer” set forth in Rule 16a-1(f) promulgated under the Exchange Act or the definition of “executive officer” set forth in Rule 3b-7 under the Exchange Act. On August 5, 2026, Dr. Rodman entered into an amendment to his Amended and Restated Employment Letter Agreement (the Amendment) to reflect his transition into a Strategic Advisor role, effective August 10, 2026. The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.Description

10.1

Amendment to Amended and Restated Employment Letter Agreement, dated August 5, 2026, by and between David Rodman, M.D., and the Company

99.1

Press Release Issued on August 11, 2026

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: August 11, 2026MINERALYS THERAPEUTICS, INC.

By:/s/ Jeffrey A. Munsie

Name:Jeffrey A. Munsie

Title:Chief Legal Officer

EX-99.1

2 mlys2026q18kex991.htm

EX-99.1

Document

Exhibit 99.1

Mineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

– NDA for lorundrostat in adults with hypertension accepted by FDA; assigned PDUFA target date of December 22, 2026 –

– Conference call today at 4:30 p.m. ET –

RADNOR, PA – May 6, 2026 – Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“We continue to make strong progress advancing lorundrostat toward potential approval, moving closer towards our goal of delivering what we believe has the potential to be a best-in-class aldosterone synthase inhibitor for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “The FDA’s acceptance of our NDA in the first quarter marks a significant milestone for Mineralys. We continue to advance pre-commercial activities to support a successful launch of lorundrostat while maintaining strategic flexibility.”

Recent Clinical Highlights and Upcoming Milestones

•Lorundrostat New Drug Application (NDA) – The U.S. Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026. The NDA submission included the diverse dataset the Company has built with lorundrostat across five positive clinical trials that demonstrated clinically meaningful blood pressure (BP) reduction, 24-hour control and a favorable safety profile in adults with uncontrolled or resistant hypertension.

•Transform-HTN Open-Label Extension Trial – The Company’s ongoing open-label extension trial, which supported the NDA submission, enables participants to continue to receive lorundrostat and allows the Company to gather additional long-term safety and efficacy data.

•Pre-Commercial Activities Underway – The Company is executing on its pre-commercial activities in preparation for the December 22, 2026 PDUFA target date for lorundrostat. This includes engaging in market access discussions, expanded medical advocacy through communications efforts in the field to support broader education of the unmet need in uncontrolled or resistant hypertension, and sales and marketing activities preparing lorundrostat for a successful launch.

First Quarter 2026 Financial Highlights

Cash, cash equivalents and investments were $646.1 million as of March 31, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials and regulatory activities, as well as support corporate operations, into 2028.

Research and development (R&D) expenses for the quarter ended March 31, 2026 were $24.4 million, compared to $37.9 million for the quarter ended March 31, 2025. The decrease in R&D expenses was primarily driven by a $15.5 million reduction in preclinical and clinical costs following the conclusion of the lorundrostat pivotal program in the second quarter of 2025. This decrease was partially offset by $1.1 million of increased clinical supply, manufacturing and regulatory costs and $0.8 million of increased personnel-related expenses resulting from headcount growth and increased compensation.

General and administrative (G&A) expenses were $21.0 million for the quarter ended March 31, 2026, compared to $6.6 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily driven by $7.9 million of higher professional fees, $6.1 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.4 million of other general and administrative expenses.

Total other income, net was $6.0 million for the quarter ended March 31, 2026, compared to $2.2 million for the quarter ended March 31, 2025. The increase reflects higher interest earned on investments in money market funds and U.S. Treasuries due to higher average cash balances invested during the quarter ended March 31, 2026.

Net loss was $39.3 million for the quarter ended March 31, 2026, compared to $42.2 million for the quarter ended March 31, 2025. The decrease was primarily attributable to the factors impacting the Company’s expenses described above.

Conference Call

The Company’s management team will host a conference call at 4:30 p.m. ET today, May 6, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States. A live webcast of the conference call may be found at (click here). A replay of t