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Mineralys Therapeutics, Inc. (MLYS)·Q1 2025 Earnings Summary

Executive Summary

  • Mineralys reported Q1 2025 net loss of $42.2M and diluted EPS of $-0.79, improving sequentially from Q4 2024 ($-0.98), and reflecting higher R&D to advance pivotal programs; cash, cash equivalents and investments totaled $343.0M after a March equity raise, extending runway “into 2027” .
  • Both pivotal hypertension trials for lorundrostat hit primary endpoints: Launch-HTN showed a 9.1 mmHg placebo-adjusted AOBP reduction at week 6, sustained to 11.7 mmHg at week 12; Advance-HTN showed a 7.9 mmHg placebo-adjusted 24-hr ABPM reduction at week 12 with favorable safety, including low confirmed hyperkalemia incidence .
  • Management plans a pre-NDA meeting with FDA in Q4 2025, while Explore-CKD topline remains targeted for Q2 2025; Explore-OSA Phase 2 was initiated in Q1 2025, broadening the cardiorenal-metabolic footprint .
  • EPS beat Wall Street consensus in Q1 2025 (actual $-0.79 vs. consensus $-0.982), following an earlier Q4 beat (actual $-0.98 vs. consensus $-1.077); the company remains pre-revenue as expected (consensus $0) *.
  • Stock catalysts over the near term include Explore-CKD topline (Q2 2025), ESH presentation for Launch-HTN in May 2025, and partnering/commercial strategy evolution under newly appointed CCO Eric Warren .

What Went Well and What Went Wrong

What Went Well

  • Pivotal efficacy success in two distinct hypertension settings: “The Advance-HTN late-breaking presentation… and the recent publication in the New England Journal of Medicine underscore the strength of our clinical data… With the success of our two pivotal trials, we are working toward submitting our new drug application… anticipated in the fourth quarter of 2025.” — CEO Jon Congleton .
  • Durable safety profile with low confirmed hyperkalemia: Launch-HTN confirmed hyperkalemia 0.6%–1.1%; Advance-HTN 2.1%–3.2%, with modest electrolyte changes and low discontinuations .
  • Strengthened balance sheet and commercial readiness: “On March 18, 2025, the Company completed a public equity financing for gross proceeds of approximately $201.2 million… reported $343.0 million of cash, cash equivalents and investments… Appointed Eric Warren as Chief Commercial Officer.” .

What Went Wrong

  • Operating losses widened YoY on elevated development costs: Q1 2025 net loss increased to $42.2M vs. $31.5M in Q1 2024, primarily from higher preclinical/clinical and compensation expenses .
  • Other income declined YoY on lower interest earnings (money market/treasuries): $2.2M in Q1 2025 vs. $3.9M in Q1 2024 .
  • Macro/tariff/inflation risks persist (supply chain/materials/capital markets), potentially affecting manufacturing and financing flexibility as noted in 10-Q risk factors .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Net Loss ($USD Millions)$56.342 $48.946 $42.211
Diluted EPS ($USD)$-1.13 $-0.98 $-0.79
R&D Expense ($USD Millions)$53.985 $44.569 $37.879
G&A Expense ($USD Millions)$6.121 $7.198 $6.568
Total Other Income, net ($USD Millions)$3.764 $2.821 $2.236
Cash, Cash Equivalents & Investments ($USD Millions)$263.603 $198.187 $343.026

Clinical KPIs (Pivotal Hypertension Program):

KPILaunch-HTNAdvance-HTN
Week 6 AOBP SBP reduction (50 mg)-16.9 mmHg absolute; -9.1 mmHg placebo-adjusted (p<0.0001) N/A
Week 12 AOBP SBP reduction-19.0 mmHg absolute; -11.7 mmHg placebo-adjusted (p<0.0001) N/A
Week 12 24-hr ABPM SBP reduction (50 mg)N/A-15.4 mmHg absolute; -7.9 mmHg placebo-adjusted (p=0.001)
Confirmed hyperkalemia (K+ >6.0 mmol/L)0.6%–1.1% (active arms) 2.1%–3.2% (active arms)

EPS vs. Consensus (S&P Global):

MetricQ3 2024Q4 2024Q1 2025
EPS Consensus ($USD)$-0.83429*$-1.07714*$-0.982*
EPS Actual ($USD)$-1.13 $-0.98 $-0.79

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporate“Through Q1 2026” (as of 12/31/2024) “Into 2027” (as of 3/31/2025) Raised runway
Advance-HTN toplineHypertensionMarch 2025 (guided) Delivered; detailed late-breaking data and NEJM publication (May 8) Achieved milestone
Launch-HTN topline/presentationHypertensionMid H1 2025 (guided) Positive topline (Mar 10); late-breaking ESH presentation (May 23–26) Achieved; scheduled presentation
Explore-CKD toplineCKDQ2 2025 (guided) Q2 2025 (reaffirmed) Maintained
Explore-OSA initiationOSAInitiation planned Q1 2025 Initiated Q1 2025 Executed
Pre-NDA meeting timelineRegulatoryNot previously specified in Q4 materials Pre-NDA with FDA anticipated Q4 2025 New timeline

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Pivotal efficacyEnrollment complete; toplines guided H1’25 Advance in March; Launch mid-H1 guided Both pivotal trials met endpoints; double-digit SBP drops Strongly improving
Safety/hyperkalemiaNAExpect modest on-target effects; diuretic synergy Low confirmed hyperkalemia; modest electrolyte changes Favorable/consistent
Regulatory pathNAACC late-breaking planned Pre-NDA Q4 2025 targeted Clearer path
Commercial readiness/partneringNAPayer research, target prescribers New CCO; prescriber survey indicates strong uptake intent Building capabilities
CKD programEnrollment completed; Q2 2025 topline guided Q2 2025 topline guided Q2 2025 topline reaffirmed; dosing strategy at 25 mg QD On track
OSA initiativeNAOSA Phase 2 cleared for initiation Trial initiated; nocturnal BP endpoints with continuous monitoring Expanding indications
Macro/tariffs/inflationNANAInflation/trade policy risks highlighted in 10-Q Ongoing external risk

Management Commentary

  • “We are pleased to have recently announced positive topline results from our pivotal trials… With the success of our two pivotal trials, we are working toward submitting our new drug application… anticipated in the fourth quarter of 2025.” — Jon Congleton, CEO .
  • “At week 6… 50 mg once daily demonstrated a 9.1 mmHg placebo-adjusted reduction… maintained at week 12… 11.7 mmHg.” — David Rodman, CMO (Launch-HTN) .
  • “Lorundrostat 50 mg… 15.4 mmHg absolute and 7.9 mmHg placebo-adjusted reduction at week 12… with favorable safety and tolerability.” — Company release on Advance-HTN .
  • “We completed a public equity financing… approximately $201.2 million… and ended the quarter with $343.0 million of cash, cash equivalents and investments… sufficient to fund… into 2027.” — Company .

Q&A Highlights

  • CKD safety/efficacy expectations: Management expects clinically meaningful BP reductions and sees nephrologists comfortable managing potassium, with potential background therapy modulation (e.g., ACE/ARB dose) .
  • Labeling and submission package: Explore-CKD will be part of the totality of evidence; OSA inclusion in filing is too early to opine .
  • Commercial model and partnering: Focus on ~47,000 high-prescribing physicians for third/fourth-line opportunity; ex-U.S. partnerships contemplated; U.S. partner could expand coverage .
  • Guidance gating for NDA: 52-week open-label extension (Transform-HTN) completion for a majority of subjects expected by Q1 2026; pre-NDA in Q4 2025 to refine submission timing .
  • OSA endpoints and nocturnal BP: 4-week timeframe expected to show benefits in AHI and nocturnal BP via continuous monitoring; potential unique nighttime BP dataset .

Estimates Context

  • Q1 2025 EPS beat: actual $-0.79 vs. consensus $-0.982; revenue expected $0, consistent with pre-revenue status *.
  • Prior quarter context: Q4 2024 actual EPS $-0.98 vs. consensus $-1.077 (beat); Q3 2024 actual EPS $-1.13 vs. consensus $-0.834 (miss) *.
  • With pivotal efficacy now de-risked and cash runway extended, Street models may adjust expected opex mix (R&D vs. pre-commercial spend) and timeline probabilities ahead of pre-NDA; revenue remains modeled at $0 through development *.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Pivotal success across real-world and specialist hypertension cohorts materially de-risks lorundrostat’s efficacy and safety profile, supporting pre-NDA in Q4 2025 and potential best-in-class positioning in third/fourth-line hypertension .
  • Safety profile, including low confirmed hyperkalemia and modest/reversible electrolyte changes, should ease clinician adoption and payer access relative to MRAs, especially in resistant populations .
  • Balance sheet strength ($343.0M cash & investments) following $201.2M raise extends runway into 2027, enabling filing prep, safety extension, and indication expansion (CKD, OSA) without near-term financing risk .
  • Near-term data catalysts: Explore-CKD topline in Q2 2025 and Launch-HTN late-breaking ESH presentation in May 2025; watch for partnering updates under new CCO .
  • EPS outperformance in Q1 (pre-revenue) reflects disciplined opex cadence and interest income; expect opex mix to pivot toward filing, commercialization planning, and medical affairs over the next 12–18 months .
  • Monitor macro/tariff/inflation risks flagged in 10-Q for potential manufacturing or financing impacts; risk management appears robust, but sector-wide conditions can influence timelines/costs .

Citations:
Financials and corporate updates: .
Estimates: Values retrieved from S&P Global.*