Mineralys Therapeutics, Inc. · NASDAQ:MLYS

Mineralys Therapeutics — Corporate Update (March 2025)

14 slides from Mineralys Therapeutics's corporate update, Mar 10, 2025

  1. Slide 1: Targeting Aldosterone in the Treatment of Cardiorenal Diseases

    Targeting Aldosterone in the Treatment of Cardiorenal Diseases L a u n c h - H T N & A d v a n c e - H T N To p l i n e D a t a March 10, 2025 Mineralys Therapeutics, Inc. ©2025. All Rights Reserved. 1

  2. Slide 2: Forward-Looking Statements and Market Data

    Forward-Looking Statements and Market Data Mineralys Therapeutics cautions you that statements contained in this presentation 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,

  3. Slide 3: Agenda

    Agenda 01 Introduction Jon Congleton 02 Launch-HTN and Advance-HTN Data Dr. David Rodman, M.D. 03 Conclusion Jon Congleton 04 Q&A Mineralys Therapeutics, Inc. ©2025. All Rights Reserved. 3

  4. Slide 4: Positive Topline Results from Launch-HTN and Advance-HTN

    Positive Topline Results from Launch -HTN and Advance-HTN Launch-HTN 19.0 mmHg absolute, and 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office BP at end of treatment, week 12 Advance-HTN 7.9 mmHg placebo-adjusted reduction assessed by 24hr ABPM at end of treatment,

  5. Slide 5: Launch-HTN Phase 3 Pivotal Trial Design

    Launch-HTN Phase 3 Pivotal Trial Design Real-World efficacy and safety trial of lorundrostat when added on top of 2-5 existing hypertension medications in uncontrolled and resistant hypertension, 1,083 subjects 2 weeks 12 weeks Placebo Run-In Double-Blind Treatment End of Study Existing background a

  6. Slide 6: Launch-HTN Robust, Statistically Significant Results

    Launch-HTN Robust, Statistically Significant Results Real-World study, how practitioners would utilize lorundrostat in daily practice for uncontrolled and resistant HTN u/r/HTN patients on existing regimen of 2-5 AHTs (n=1,083) on 50 mg lorundrostat QD ▪ Baseline demographics: Week 6 Week 12 ▪ ~63%

  7. Slide 7: Launch-HTN Topline Safety Summary

    Launch-HTN Topline Safety Summary Launch-HTN trial demonstrated that lorundrostat delivered a compelling safety profile SAEs 0.7 % to 2.4%, TEAEs leading to dosing discontinuation 1.5% to 2.6% Lorundrostat Lorundrostat Placebo Total 50 mg QD 50 mg to 100 mg QD N=270 N=1,078 N=538 N=270 % N Events %

  8. Slide 8: Advance-HTN Phase 2 Pivotal Trial Design

    Advance-HTN Phase 2 Pivotal Trial Design Confirmatory efficacy and safety trial of lorundrostat in uncontrolled and resistant hypertension, 285 subjects 3 weeks 12 weeks 4 weeks Optimized AHT Regimen Double-Blind Treatment Washout Run-In Continue standardized background regimen* Placebo QD Primary e

  9. Slide 9: Advance-HTN Robust, Statistically Significant Results

    Advance-HTN Robust, Statistically Significant Results Specialist driven trial, testing lorundrostat benefit when added to optimized background with 24 hr ABPM Confirms 50mg QD dose 5.3% and 7.4% hyperkalemia rate, in 50mg and 50mg to 100mg arms, respectively Full topline data at ACC.25 7.9* Previous

  10. Slide 10: Lorundrostat Development Program with Positive Pivotal Data and Market Expansion Proof-of-Concept Trials

    Lorundrostat Development Program with Positive Pivotal Data and Market Expansion Proof-of-Concept Trials Trial Safety Proof of Concept Pivotal Key Milestones -7.9mmHg PBO uHTN & rHTN Standardized background AHT COMPLETED adjusted at week 12 Hypertension -11.7mmHg PBO uHTN & rHTN Existing background

  11. Slide 11: Lorundrostat Positioned in 3rd and 4th Line Treatment

    L o r u n d r o s t a t P o s i t i o n e d i n 3 rd a n d 4 th L i n e T r e a t m e n t Advance-HTN and Launch-HTN results demonstrate opportunity of lorundrostat in 3L or later treatment Prevalent HTN 120M1 Treated HTN 60M2 uHTN (1 AHT) ~10M uHTN (2 AHT) 50% of Rx for 3L ~10M Uncontrolled - 3rd L

  12. Slide 12: Lorundrostat in uncontrolled and resistant hypertension

    Lorundrostat in uncontrolled and resistant hypertension Demonstrated Demonstrated Demonstrated safety and efficacy efficacy and safety efficacy and safety in n=200 in confirmed u/rHTN largest ever ASI trial n=285 in HTN n=1,083 Full Data, September 2023 Topline Data, March 2025 Topline Data, March 2

  13. Slide 13: Q&A

    Q&A Mineralys Therapeutics, Inc. ©2025. All Rights Reserved. 13

  14. Slide 14: Mineralys Therapeutics, Inc. ©2025. All Rights Reserved.

    Mineralys Therapeutics, Inc. ©2025. All Rights Reserved. 14

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