Sign in

You're signed outSign in or to get full access.

MM

Mind Medicine (MindMed) Inc. (MNMD)·Q3 2025 Earnings Summary

Executive Summary

  • Pre-revenue quarter with operating expense ramp; Q3 2025 net loss widened to $67.3M ($0.78/share) vs $13.7M ($0.18/share) in Q3 2024 and $42.7M ($0.50/share) in Q2 2025, driven by higher R&D and G&A and a non‑cash $22.5M increase in warrant fair value as the stock rose in the quarter .
  • EPS missed S&P Global consensus: ($0.78) actual vs ($0.50) consensus; revenue remained at $0 (consensus $0), reflecting development-stage status; 10 EPS estimates and 11 revenue estimates in the quarter (values from S&P Global)*.
  • Clinical execution momentum: eMERGE (Phase 3 MDD) topline pulled forward to mid‑2026 (from 2H26), while VOYAGE (GAD) remains 1H26 and PANORAMA (GAD) 2H26; JAMA publication of Phase 2b GAD validated dose response and durability .
  • Balance sheet significantly strengthened: $209.1M cash, equivalents and investments at 9/30/25 and $242.8M net proceeds from the Oct 31 offering; management guides cash runway into 2028, supporting NDA preparation and launch readiness for MM120 ODT .
  • 2026 framed as catalyst-heavy: three Phase 3 topline readouts across GAD and MDD, initiation of second MDD pivotal (ASCEND), and advancement of MM402 into Phase 2a for ASD in 4Q25; management tone confident, emphasizing rigorous trial designs and FDA engagement .

What Went Well and What Went Wrong

What Went Well

  • Accelerated MDD timeline: eMERGE topline moved up to mid‑2026 on faster‑than‑expected enrollment; VOYAGE (1H26) and PANORAMA (2H26) remained on track, concentrating key readouts in 2026 .
  • Scientific validation: Phase 2b GAD results published in JAMA showed dose response; 100 μg achieved a 7.7‑point placebo‑adjusted HAM‑A reduction at Week 12, 65% response, 48% remission after a single dose, underpinning Phase 3 design and Breakthrough status .
  • Capital raised and runway extended: $258.9M gross/$242.8M net offering completed Oct 31; combined with $209.1M on 9/30, cash runway guided into 2028 to fund NDA workstreams and commercial readiness .
  • Management quotes:
    • “This financing…positions us for a transformational 2026” (CEO) .
    • “We’ve designed our Phase 3 trials to have 90% power to detect a 5‑point improvement over placebo” (CMO) .
    • “Cash…along with the net proceeds from the recent offering, are sufficient to fund…into 2028” (CFO) .

What Went Wrong

  • EPS miss vs Street: ($0.78) actual vs ($0.50) consensus, driven by R&D (+$13.8M YoY) and G&A (+$7.1M YoY) plus non‑cash warrant fair value change ($22.5M), magnifying the net loss .
  • Operating expense escalation: R&D rose to $31.0M from $17.2M YoY on MM120 program and hiring; G&A increased to $14.7M from $7.6M on personnel, commercial prep, and corporate affairs, signaling sustained spend into 2026 .
  • Limited trial detail disclosures: No public update on blinded sample size re‑estimation and no interim blinded metrics (persistency/dropout); management emphasized adherence to plans without additional specifics, leaving some analysts seeking more visibility .

Financial Results

P&L and Cash (oldest → newest)

MetricQ3 2024Q2 2025Q3 2025
Revenue ($M)— (pre‑revenue)— (pre‑revenue)— (pre‑revenue)
R&D Expense ($M)$17.19 $29.81 $30.98
G&A Expense ($M)$7.60 $11.09 $14.69
Total Operating Expenses ($M)$24.79 $40.90 $45.67
Net Loss ($M)$(13.68) $(42.74) $(67.27)
Diluted EPS ($)$(0.27) $(0.50) $(0.78)
Cash, Equivalents & Investments ($M)—$237.9 $209.1
Shares (Wtd Avg, Basic) (M)80.24 85.35 85.89

Notes: Company reported no product revenue; statements present only operating expenses and other income/expense items .

Results vs S&P Global Consensus (Q3 2025)

MetricConsensusActualSurprise
EPS (Primary)$(0.50)*$(0.78) $(0.28)
Revenue ($M)$0.0*— (pre‑revenue)—
EPS Estimates (#)10*——
Revenue Estimates (#)11*——
Target Price ($)$25.64*$25.64*—
Target Price Estimates (#)11*11*—

*Values retrieved from S&P Global.

Additional Drivers (Q3 2025)

  • Non‑cash warrant fair value change: $(22.55)M impact as stock moved from $6.49 (6/30) to $11.79 (9/30) .
  • Interest income/expense: $2.26M / $(1.27)M, reflecting elevated cash/investments and credit facility usage .

Guidance Changes

Metric/ProgramPeriodPrevious GuidanceCurrent GuidanceChange
VOYAGE (MM120 ODT – GAD, 100μg vs PBO)Topline Part A1H 2026 1H 2026 Maintained
PANORAMA (MM120 ODT – GAD, 100μg/50μg/PBO)Topline Part A2H 2026 2H 2026 Maintained
eMERGE (MM120 ODT – MDD, 100μg vs PBO)Topline Part A2H 2026 Mid‑2026 Raised (earlier)
ASCEND (MM120 ODT – MDD, 100μg/50μg/PBO)Study StartTBD (2H 2025‑26 dependent) Mid‑2026 start Set timing
MM402 (R‑MDMA) – ASDPhase 2a StartFurther studies expected 4Q 2025 single‑dose open‑label in up to 20 adults Firmed initiation
Cash Runway—Into 2027 Into 2028 (post offering) Extended

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1–Q2 2025)Current Period (Q3 2025)Trend
Pivotal timelines (VOYAGE/PANORAMA/eMERGE)On track: VOYAGE 1H26; PANORAMA & eMERGE 2H26 eMERGE pulled forward to mid‑2026; VOYAGE/PANORAMA unchanged Positive acceleration in MDD
Rigor of design & blindingEmphasis on robust Phase 3 modeled on Phase 2b 90% power for 5‑point delta; functional blinding controls (central raters, expectancy questionnaires, 50μg arm) Reinforced methodological strength
Regulatory engagementBreakthrough in GAD; strategy defined “Constructive dialogue” with FDA; Part A data pivotal for NDA; AdCom readiness if needed Continued alignment
Commercial preparednessAdded CCO (Q1); building launch plan Use of proceeds for NDA prep, scheduling, market research, KOL education Increased investment
Capital positionCash into 2027 $242.8M net raise; runway into 2028 Strengthened
Scientific validationPhase 2b data previously top‑lineFull JAMA publication with 7.7 pt delta; 65% response/48% remission De‑risking efficacy narrative
MM402 (ASD)Phase 1 completed; studies anticipated Phase 2a starting 4Q25; acute prosocial rationale; potential at‑need dosing Program advancing

Management Commentary

  • Strategy and 2026 catalysts: “This financing underscores the strength of our science and positions us for a transformational 2026…three top-line Phase III data readouts expected” (CEO) .
  • Phase 3 powering: “We’ve designed our Phase III trials to have 90% power to detect a 5‑point improvement over placebo” (CMO) .
  • Durability & potential sea change: “A single monotherapy intervention…induce remission in just under 50%…12 weeks later…a remarkable opportunity for potential sea change in psychiatry” (CMO) .
  • Cash runway and priorities: Cash and investments of $209.1M at 9/30 and $242.8M net proceeds; “sufficient to fund…into 2028…accelerate key initiatives…NDA preparation…KOL education” (CFO) .
  • Commercial model vs Spravato: MM120’s durable effects and single‑dose paradigm contrasted with Spravato’s dynamics; ability to leverage infrastructure and reimbursement codes without co‑administered psychotherapy (CEO) .

Q&A Highlights

  • Sample size re‑estimation: No public disclosure yet on blinded re‑estimation; timelines remain intact (VOYAGE/PANORAMA 2026) .
  • Enrollment dynamics: Strong across GAD and MDD; advancement of eMERGE timing reflects earlier‑than‑expected start and throughput .
  • Functional blinding and dose response: 50μg arm serves as functional control; primary endpoints test 100μg vs placebo; Phase 2b established dose response despite unblinding risk .
  • Durability/retreatment: No deterioration out to Week 12 in Phase 2b; Part B of Phase 3 will characterize re‑treatment intervals (HAM‑A/MADRS thresholds) .
  • MM402 usage paradigm: Envisioned as daily/as‑needed to enhance social communication in ASD; rationale based on acute prosocial effects and tolerability profile .

Estimates Context

  • Q3 2025 EPS came in below consensus: ($0.78) vs ($0.50) consensus; miss driven by higher R&D/G&A and a non‑cash $22.5M warrant fair value loss as shares appreciated; revenue remained at $0 (consensus $0)* .
  • Target price consensus stood at ~$25.64 with 11 estimates in the quarter, indicating constructive long‑term expectations pending Phase 3 data (values from S&P Global)*.
  • Modeling implications: OpEx run‑rate suggests sustained R&D through 2026 to support three pivotal readouts and commercial build; non‑cash warrant volatility can materially swing reported EPS quarter‑to‑quarter .

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • 2026 is the inflection year: three Phase 3 readouts across GAD and MDD, with eMERGE pulled into mid‑2026; regulatory path emphasizes Part A data for efficacy (12‑week GAD; 6‑week MDD) .
  • De‑risked efficacy thesis: JAMA Phase 2b shows single‑dose durability and dose response (7.7 pt HAM‑A delta; 65% response; 48% remission), aligning Phase 3 designs and powering assumptions .
  • EPS volatility likely near term: Pre‑revenue profile plus non‑cash warrant revaluations can obscure underlying cash use; focus on OpEx trends and cash runway into 2028 .
  • Commercial groundwork underway: Proceeds earmarked for NDA prep, scheduling prioritization, and KOL education; management sees leverage from existing interventional psychiatry infrastructure .
  • Secondary program optionality: MM402’s Phase 2a start in 4Q25 opens an additional neuropsychiatry avenue (ASD) with a distinct daily/as‑needed use case .
  • Near‑term catalysts: Continued enrollment updates; any regulatory guidance clarity; additional scientific publications; and progress on commercialization planning could move sentiment .
  • Risk monitor: Lack of visibility on sample size re‑estimation, execution risk in pivotal trials, and warrant/market‑driven EPS noise warrant attention .