Executive Summary

Q3 2025 delivered a cleaner P&L and lower loss per share as R&D stepped down post pivotal program, with EPS at -$0.52 versus Wall Street consensus of -$0.61 (beat), and net loss of $36.9M vs $56.3M in Q3 2024; cash and investments rose to $593.6M after a $287.5M September financing, extending runway into 2028 . Primary EPS Consensus Mean for Q3 2025 was -$0.61286* (actual -$0.52) and revenue consensus was $0*, consistent with pre-commercial status. Values retrieved from S&P Global.
NDA submission for lorundrostat is targeted for late-2025 or Q1 2026 following pre-NDA FDA feedback with “no surprises,” while Explore-OSA enrollment is complete with topline results anticipated in Q1 2026; Explore-CKD data showed clinically meaningful BP and UACR reductions (ASN late-breaker) .
Quarter-over-quarter, R&D fell to $31.5M (from $38.3M in Q2) as pivotal work concluded; G&A rose to $9.7M on compensation/pro fees; other income increased to $4.2M on higher interest; overall loss narrowed sequentially (EPS -$0.52 vs -$0.66) .
Stock narrative hinges on regulatory progress (NDA filing window), differentiation vs competing ASIs, and near-term clinical catalysts (Explore-OSA Q1 2026); partnership updates (U.S. and ex-U.S.) are a potential upside catalyst given management’s stated strategy .

What Went Well and What Went Wrong

What Went Well

“We are at an exciting point…prepare for our NDA submission…near the end of 2025 or during Q1 2026,” underscoring regulatory momentum after “no surprises” in pre-NDA feedback .
Explore-CKD demonstrated clinically meaningful BP reduction in 4 weeks and highly statistically significant UACR reduction, with strong HCP interest (77% would consider prescribing in CKD on ACE/ARB), strengthening lorundrostat’s cardiorenal profile .
Q3 loss narrowed YoY and QoQ as R&D moderated post-pivotal program; cash rose to $593.6M after a $287.5M financing, extending runway into 2028 .

What Went Wrong

No product revenue and continued net losses; G&A increased YoY to $9.7M on compensation and professional fees; ongoing cash burn despite improved runway .
Nighttime BP data not yet disclosed, a point of investor focus given competitor messaging on 24-hour control; management indicates comfort but will publish later .
Handling of missing data and imputation was a Q&A focus; management emphasized pre-negotiated SAP with FDA and limitations of post hoc estimates—reducing scope for favorable re-cuts .

Financial Results

Quarterly P&L and Cash (oldest → newest)

Metric	Q1 2025	Q2 2025	Q3 2025
R&D Expense ($USD Millions)	$37.9	$38.3	$31.5
G&A Expense ($USD Millions)	$6.6	$8.5	$9.7
Total Operating Expenses ($USD Millions)	$44.4	$46.7	$41.1
Total Other Income, net ($USD Millions)	$2.2	$3.5	$4.2
Net Loss ($USD Millions)	$42.2	$43.3	$36.9
Net Loss per Share ($)	-$0.79	-$0.66	-$0.52
Weighted Avg Shares (Millions)	53.2	65.5	70.6
Cash, Cash Equivalents & Investments ($USD Millions)	$343.0	$324.9	$593.6

EPS vs Wall Street Consensus (oldest → newest)

Metric	Q1 2025	Q2 2025	Q3 2025
EPS Actual ($)	-$0.79	-$0.66	-$0.52
EPS Consensus Mean ($)	-$0.982*	-$0.73857*	-$0.61286*

Values retrieved from S&P Global.

Year-over-Year Q3 Comparison

Metric	Q3 2024	Q3 2025
R&D Expense ($USD Millions)	$54.0	$31.5
G&A Expense ($USD Millions)	$6.1	$9.7
Total Other Income, net ($USD Millions)	$3.8	$4.2
Net Loss ($USD Millions)	$56.3	$36.9
Net Loss per Share ($)	-$1.13	-$0.52
Weighted Avg Shares (Millions)	49.8	70.6
Cash, Cash Equivalents & Investments ($USD Millions)	N/A	$593.6

Note: Company is pre-commercial; revenue not reported in the press releases and consensus revenue was $0* for Q1–Q4 2025. Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Corporate runway	“Into 2027” (Q2 PR)	“Into 2028” (Q3 PR)	Raised
Explore-OSA topline timing	Clinical milestone	“1H 2026” (Q2 PR)	“Q1 2026” (Q3 PR)	Raised (pulled forward)
NDA submission window	Regulatory milestone	Working toward NDA; pre-NDA in Q4 2025 (Q1 PR)	“Near end of 2025 or Q1 2026” (Q3 PR)	Maintained (clarified)
Pre-NDA meeting status	Regulatory milestone	“Pre-NDA meeting scheduled in Q4 2025” (Q2 PR)	“Received pre-NDA feedback last month” (Q3 call)	Completed

No quantitative guidance provided for revenue, margins, OpEx beyond historical disclosure, OI&E, tax rate, or dividends in Q3 materials .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025)	Previous Mentions (Q2 2025)	Current Period (Q3 2025)	Trend
Regulatory/NDA	Pre-NDA anticipated in Q4 2025	Pre-NDA scheduled in Q4 2025	Pre-NDA feedback “no surprises”; NDA near end-2025/Q1 2026	Progressing to filing
R&D execution/hard-to-treat HTN	Pivotal Advance/Launch met endpoints	Publications in NEJM/JAMA; detailed efficacy data	Confidence in best-in-class profile; consistent 24h control	Reinforcing differentiation
CKD program	Explore-CKD topline imminent	Positive topline with BP/UACR reductions	ASN late-breaker; strong HCP interest	Strengthening renal angle
OSA program	Initiated Explore-OSA	Ongoing; topline 1H 2026	Enrollment complete; topline Q1 2026; nighttime dosing explored	Pulled-forward milestone
Partnering	CCO appointment; commercial prep	—	Ongoing dialogues; U.S & ex-U.S. lift strategy	Active evaluation
Competitive landscape	—	—	Day/night BP and half-life vs competitors; diverse trial populations	Framing differentiation

Management Commentary

“We are at an exciting point…following pre-NDA feedback…we anticipate submitting near the end of 2025 or during the first quarter of 2026.” — Jon Congleton, CEO .
“We are more confident than ever in lorundrostat’s best-in-class profile based on meaningful blood pressure reduction, demonstrated 24-hour control, benefit across difficult-to-treat patients, and safety and tolerability.” — CEO prepared remarks .
“We ended the quarter with cash, cash equivalents, and investments of $593.6 million…sufficient to fund…into 2028.” — Adam Levy, CFO .
“Explore-CKD…clinically meaningful reduction in systolic BP…UACR…highly statistically significant…77% of HCPs would consider prescribing.” — CEO .
“We completed enrollment in Explore-OSA…topline in the first quarter of 2026…trial will explore nighttime dosing.” — CEO .

Q&A Highlights

Missing data/imputation: FDA expectations require pre-specified SAP; “jump to reference” is most conservative; post hoc re-estimation not feasible after database lock .
Day/night BP: Company comfortable with 24-hour control across studies; nighttime metrics not yet disclosed, to be published later .
Pre-NDA specifics: “No surprises” in FDA feedback; submission window remains end-2025/Q1 2026 .
Partnering: Active dialogues for U.S. commercial lift and ex-U.S. commercialization/co-development; maximizing value for stakeholders remains focus .
Diversity/efficacy to goal: Black/African-American representation >50% in Advance-HTN and ~30% in Launch-HTN; response consistent across races; “got to goal” ~44% (Launch, week 6) and ~42% (Advance, week 4), placebo ~half; stricter goal definition (125 vs 130) than comparator trial .

Estimates Context

Q3 2025 EPS actual -$0.52 beat consensus -$0.61286*; Q2 2025 EPS actual -$0.66 beat consensus -$0.73857*; Q1 2025 EPS actual -$0.79 beat consensus -$0.982*. Consensus revenue was $0* across quarters, consistent with pre-commercial stage. Values retrieved from S&P Global.
Target Price Consensus Mean stood at $47.625*; Consensus Recommendation (Text) unavailable in the pull. Values retrieved from S&P Global.

Key Takeaways for Investors

Regulatory path is intact: pre-NDA feedback had “no surprises,” and NDA filing window remains late-2025/Q1 2026—core near-term catalyst .
Balance sheet strength with $593.6M cash/investments and runway extended into 2028 reduces financing overhang, enabling launch preparation and further trials .
Continued EPS beats reflect disciplined spend post-pivotal program and rising interest income; sequential loss per share improvement supports near-term sentiment .
Explore-CKD validated BP and renal biomarker (UACR) effects; Explore-OSA topline pulled forward to Q1 2026 could broaden use-case and reinforce 24-hour control narrative .
Differentiation vs competitors centers on diverse populations, confirmed resistant HTN design, morning trough measurements, and safety/tolerability profile in electrolytes .
Partnering remains a strategic lever for U.S. commercialization lift and ex-U.S. reach; updates could be incremental stock catalysts .
Trading implications: Near-term focus on NDA timing disclosures and any nighttime BP data publications; medium-term thesis builds on label breadth (uncontrolled/resistant HTN), comorbidity advantage (CKD/OSA), and capitalized launch infrastructure .

Mineralys Therapeutics, Inc. (MLYS)·Q3 2025 Earnings Summary