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PMV Pharmaceuticals, Inc. (PMVP)·Q3 2025 Earnings Summary

Executive Summary

  • EPS was in line with consensus: reported $(0.40) vs Wall Street consensus of $(0.40); revenue was not reported and consensus expected $0.00.* *
  • Cash, cash equivalents, and marketable securities were $129.3M, extending expected cash runway to end of Q1 2027, from “end of 2026” earlier. This reflects spend pacing and strong interest income.
  • Clinical efficacy strengthened: overall ORR rose to 34% (from 33%) with median DOR 7.6 months; ovarian ORR reached 46% with 8.0-month median DOR, reinforcing the registrational strategy.
  • Regulatory timeline was pushed: NDA for platinum-resistant/refractory ovarian cancer now planned for Q1 2027 (prior guide: end of 2026), and the FDA requested enrolling 20–25 additional ovarian patients by end of Q1 2026 — a key stock catalyst path.

What Went Well and What Went Wrong

What Went Well

  • Strengthening efficacy signals: 34% overall ORR across 103 evaluable patients; ovarian ORR at 46% with durable responses (median 8.0 months), with confirmed responses across eight tumor types.
  • Clear strategic momentum: “We are excited by the data emerging... and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer.” — David Mack, CEO.
  • Safety profile supports chronic use: Grade 3 TRAEs were ≤6% and manageable; administration with food improved GI tolerability vs Phase 1.

What Went Wrong

  • Loss widened year-over-year: Q3 net loss was $21.1M vs $19.2M in Q3 2024, driven by higher R&D spend advancing rezatapopt.
  • Regulatory milestone slips: NDA timing moved from end of 2026 to Q1 2027; FDA ask to enroll 20–25 additional ovarian patients extends timelines.
  • Continued cash burn: Net cash used in operations was $56.4M for nine months vs $34.6M in prior-year period; G&A down, but R&D up with CRO costs.

Financial Results

Profitability and Cash

MetricQ1 2025Q2 2025Q3 2025
Net Loss ($USD Millions)$17.436 $21.210 $21.059
Diluted EPS ($USD)$(0.34) $(0.41) $(0.40)
Total Operating Expenses ($USD Millions)$21.564 $22.879 $22.522
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$165.8 $148.3 $129.3
Cash and Equivalents ($USD Millions)$51.341 $44.127 $36.337

Notes: PMVP did not report product revenue; consensus expected $0.00.* [GetEstimates]*

Operating Expenses Breakdown

MetricQ1 2025Q2 2025Q3 2025
R&D ($USD Millions)$17.441 $18.400 $18.210
G&A ($USD Millions)$4.123 $4.479 $4.312

EPS vs Consensus (Q3 2025)

MetricQ3 2025
EPS Actual ($USD)$(0.40)
Primary EPS Consensus Mean ($USD)$(0.40)*
Surprise ($USD)$0.00*
EPS – # of Estimates4*
Revenue Consensus Mean ($USD)$0.00*
Revenue – # of Estimates3*

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
NDA filing – platinum-resistant/refractory ovarian cancerInitial submissionEnd of 2026 Q1 2027 Lowered (timeline pushed)
Additional ovarian enrollmentBy end of Q1 2026Not specified+20–25 patients requested by FDA New requirement
Cash runwayCorporateEnd of 2026 End of Q1 2027 Raised/extended
Clinical efficacy targetsPhase 2Target ~30% ORR overall (design objective) Achieved 33–34% overall ORR; ovarian 43–46% ORR Outperforming design targets

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available in the document system; we searched for “earnings-call-transcript” and found none. We reference prior discussions (Feb 12, 2025 transcript) and Q3 press releases.

TopicPrevious Mentions (Q2 2025)Previous Mentions (Q1 2025)Current Period (Q3 2025)Trend
Regulatory/NDA timelineNo update provided Anticipated NDA by end-2026 NDA now Q1 2027; FDA asks for +20–25 ovarian patients Slipped
Cash runway“End of 2026” “End of 2026” Extended to end of Q1 2027 Improving runway
Clinical efficacy (ORR, DOR)Interim analysis scheduled; no metrics yet Interim planned mid-2025 Overall ORR 33–34%; ovarian 43–46%; median DOR overall 6.2→7.6 months; ovarian 7.6→8.0 months Strengthening
KRAS wild-type requirement—Phase 1 showed better durability in KRAS WT; strategy focused on KRAS WT Confirmed KRAS WT inclusion; efficacy across eight tumor types Consistent
Combination strategies (pan-RAS)—Preclinical studies launched; biology consistent Not updated in Q3 releasesUnder evaluation
Safety/Tolerability——Grade 3 TRAEs ≤6%; improved GI tolerability with food Favorable

Management Commentary

  • “I am incredibly proud of our team… We are excited by the data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer.” — David Mack, Ph.D., President & CEO.
  • “Updated results… continue to enhance our understanding… improvements in ORR and median duration of response… further support the potential of rezatapopt…” — Deepika Jalota, Pharm.D., Chief Development Officer.
  • “The rezatapopt data… demonstrate very encouraging clinical activity… providing a potential shift in the current treatment paradigm.” — Alison M. Schram, M.D., MSKCC.

Q&A Highlights

  • KRAS co-mutation impact: Phase 1 showed reduced durability in KRAS-mutated patients vs KRAS WT, hypothesized immunosuppressive environment; supports a potential future pan-RAS combination.
  • Ovarian cohort bar and endpoints: Expectation that single-arm ORR and DOR (median ≥6 months) paired with tolerable safety can be sufficient for FDA approval; study designed to target ~30% ORR overall.
  • Capital planning: Management indicated multiple mechanisms under evaluation to bridge to NDA submission, expecting data to facilitate discussions.

Estimates Context

  • Q3 EPS was in line with consensus: actual $(0.40) vs consensus $(0.40); revenue consensus was $0.00 as PMVP remains pre-revenue.* *
  • With R&D and CRO costs driving opex, consensus models should refine cash runway assumptions (+1 quarter) and incorporate the FDA-requested incremental ovarian enrollment, pushing NDA to Q1 2027 and extending trial costs.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum: Efficacy improved quarter-over-quarter (ORR and DOR), particularly in ovarian, supporting the registrational thesis and potential label durability requirements.
  • Timeline shift is central: NDA moved to Q1 2027 with an FDA-requested ovarian enrollment boost; models must reflect extended timelines and costs.
  • Cash runway extended: $129.3M in liquidity now expected to fund operations through end of Q1 2027 — reduces near-term financing risk vs prior guidance.
  • Safety/tolerability strengthens commercial narrative: manageable Grade 3 TRAEs and improved GI tolerability with food are positive for adherence and chronic use.
  • EPS tracked consensus; focus is on clinical/regulatory catalysts rather than near-term P&L — watch upcoming enrollment updates and further data confirmations.
  • Strategic optionality: KRAS WT focus with exploratory pan-RAS combination work could broaden applicability; monitoring preclinical/clinical combo updates is warranted.
  • Near-term catalysts: Additional confirmed responses, ovarian cohort enrollment progress, companion diagnostics/regulatory engagement updates, and potential investor events can move the stock narrative.

Additional notes: We read the Q3 2025 8-K 2.02 press release in full, plus all relevant Q3 press releases. No Q3 earnings call transcript was available; prior transcript material from Feb 12, 2025 was used to inform Q&A context.