Mineralys Therapeutics, Inc. filings document the public-company disclosures of a biopharmaceutical issuer developing lorundrostat for hypertension and related comorbidities driven by dysregulated aldosterone. Form 8-K reports cover quarterly and annual financial results, corporate updates, Regulation FD disclosures, FDA acceptance of the lorundrostat New Drug Application, and clinical results from the Explore-OSA exploratory trial.
The filing record also includes proxy materials for annual meeting voting and stockholder procedures, along with material-event disclosures for capital-structure matters. These include common stock arrangements under an ATM Equity Offering Sales Agreement, registration-statement references, material agreements, and shareholder voting matters.
Mineralys Therapeutics insider activity: Dr. David Malcom Rodman, the company's Chief Medical Officer, exercised options and sold common stock under a Rule 10b5-1 plan. On 08/12/2025 he exercised stock options to acquire 6,349 shares at an exercise price of $1.08, increasing his direct beneficial ownership to 104,256 shares. The related option grants vesting details are stated: 25% vested on 07/12/2022 with the remainder vesting in 36 monthly installments. On 08/13/2025 he sold 11,365 shares at a weighted-average price of $12.9333, with sale prices ranging from $12.590 to $13.223. The transactions were effected pursuant to a 10b5-1 trading plan adopted on 10/25/2024.
Mineralys Therapeutics (MLYS) Schedule 13G/A reports that BioDiscovery 6 FPCI, Andera Partners and two Andera managing partners, Stephane Bergez and Francois Xavier Mauron, together may be deemed to beneficially own 2,765,976 shares of common stock, representing 4.2% of the class based on 65,175,287 shares outstanding as of May 8, 2025. The shares are held of record by BioDiscovery 6; voting and dispositive authority is shared (no sole voting or dispositive power reported). The filers disclaim status as a group. The filing discloses Paris as the reporting persons' principal address and includes a joint filing agreement as an exhibit.
Catalys Pacific entities and an individual reported shared beneficial ownership of 8,978,954 shares, representing 13.5% of Mineralys Therapeutics, Inc. The filing states this total includes 8,903,838 shares held of record by Catalys Pacific Fund, LP and 75,116 shares underlying options exercisable within 60 days of June 30, 2025. The reporting group consists of Catalys Pacific Fund, LP; Catalys Pacific Fund GP, LP; Catalys Pacific, LLC; and Brian Taylor Slingsby, who is the managing director and signed the filing on August 14, 2025. Ownership figures are based on 66,295,184 shares outstanding as disclosed by the issuer.
Mineralys Therapeutics (MLYS) filed a Form 144 to notify a proposed sale of 11,365 shares of common stock, with an aggregate market value of $146,987.47. The shares were acquired on 08/12/2024 by cash exercise of employee stock options from Mineralys Therapeutics, Inc., and the proposed sale is to be executed through Merrill Lynch on NASDAQ with an approximate sale date of 08/13/2025. The company reports 66,295,184 shares outstanding.
The filing also discloses recent sales by the same seller: 11,366 shares sold on 06/13/2025 for $165,930.95 and 11,366 shares sold on 07/14/2025 for $165,878.90. The filer affirms they are not aware of undisclosed material information and includes the standard signature/representation language required by Rule 144.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat, an oral aldosterone synthase inhibitor for cardiorenal conditions. Two pivotal trials (Launch-HTN and Advance-HTN) met their primary endpoints with clinically meaningful, placebo-adjusted reductions in systolic blood pressure: Launch-HTN pooled 50 mg showed a placebo-adjusted reduction of ~9.1 mmHg at week 6 and ~11.6 mmHg at week 12; Advance-HTN demonstrated a placebo-adjusted ~7.9 mmHg reduction in 24-hour ambulatory systolic BP at week 12. A Phase 2 Explore-CKD crossover trial reported a placebo-adjusted systolic BP reduction of 7.5 mmHg (p=0.0024) and a 25.6% placebo-adjusted reduction in UACR (p=0.0015).
Safety signals included confirmed hyperkalemia in some cohorts (Launch-HTN confirmed rates up to 1.1%; Advance-HTN confirmed up to 3.2%; Explore-CKD 5% on drug) and modest mean eGFR declines in Explore-CKD. As of June 30, 2025, the company held $324.9 million in cash, cash equivalents, and investments, recorded a six-month net loss of $85.5 million, used $75.7 million of cash in operations in the six months, and had an accumulated deficit of $388.0 million. Management plans a pre-NDA meeting with the FDA in Q4 2025 and states current funds are sufficient for at least twelve months.
Mineralys Therapeutics, Inc. furnished a press release announcing its financial results for the quarter ended June 30, 2025 and provided a corporate update; the press release is attached to this Form 8-K as Exhibit 99.1. The Form 8-K states the exhibit is furnished and therefore not deemed "filed" for purposes of Section 18 of the Exchange Act and is not incorporated by reference in other filings except as expressly noted.
The filing confirms the company’s common stock trades under MLYS on Nasdaq and indicates the registrant qualifies as an emerging growth company. No financial tables or numerical results are included in the 8-K text itself; readers must consult Exhibit 99.1 for the full financial details and corporate update.
Mineralys Therapeutics (MLYS) – Form 4 filed 30-Jul-2025
CFO & Secretary Adam S. Levy reported open-market sales of 73,678 common shares across three trading days:
- 28-Jul-2025: 12,946 sh. at a weighted avg. $14.0432
- 29-Jul-2025: 807 sh. at $14.0048
- 30-Jul-2025: 51,500 sh. at $14.7023 and 8,425 sh. at $15.0983
Levy now directly owns 132,934 shares. Arithmetic implies his stake fell from 206,612 to 132,934 shares, a reduction of roughly 36 %. No derivative transactions were reported, and the filing does not state that the sales were executed under a Rule 10b5-1 trading plan.