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Edgewise Therapeutics, Inc. (EWTX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 results were broadly in line: GAAP diluted EPS of -$0.39 versus Wall Street consensus of -$0.3993; no product revenue reported as the company remains pre-commercial. Slight EPS beat reflects disciplined OpEx and interest income, though R&D rose with pipeline progression *.
  • Balance sheet remains strong with $563.3 million in cash, cash equivalents and marketable securities, supporting late-stage programs and building commercial infrastructure ahead of potential Becker launch .
  • Operational guidance maintained: CIRRUS-HCM Phase 2 program update remains slated for Q4 2025, GRAND CANYON (Becker) topline in Q4 2026; new clarity added on EDG-15400 Phase 1 topline in H1 2026 .
  • Near-term stock catalysts: CIRRUS-HCM program update in Q4 2025, regulatory interactions on Duchenne Phase 3 strategy, and continued MESA data read-throughs in Becker supporting potential commercial launch positioning .

What Went Well and What Went Wrong

What Went Well

  • “With a strong balance sheet, we continue to make great progress on our cardiac and skeletal muscle programs… building the commercial infrastructure to support a potential launch of sevasemten in Becker” .
  • MESA open-label extension in Becker has enrolled 99% of eligible participants, reinforcing long-term safety and functional stabilization narrative .
  • EDG-7500 CIRRUS-HCM Phase 2 continues to advance with strong enrollment in Part D; program update remains on track for Q4 2025 .

What Went Wrong

  • Net loss widened sequentially as R&D increased with EDG-15400 Phase 1 start, continued CIRRUS-HCM activity, and Becker trial roll-overs: Q3 net loss -$40.7M vs. -$36.1M in Q2 .
  • Interest income modestly declined ($6.192M vs. $6.495M in Q2), partially offsetting higher OpEx but not enough to prevent sequential EPS deterioration [-$0.39 vs. -$0.34] .
  • Still no product revenue; company reiterates it has not generated any revenue to date, keeping Street focus on clinical execution and timelines .

Financial Results

Income Statement and OpEx Comparison

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Loss ($USD Millions)-$34.129 -$40.798 -$36.115 -$40.666
Diluted EPS ($USD)-$0.3638 -$0.43 -$0.34 -$0.39
Total Operating Expenses ($USD Millions)$40.432 $45.959 $42.610 $46.858
Interest Income ($USD Millions)n/a$5.161 $6.495 $6.192

Operating Expense Detail

MetricQ1 2025Q2 2025Q3 2025
Research & Development ($USD Millions)$36.757 $33.558 $37.480
General & Administrative ($USD Millions)$9.202 $9.052 $9.378

R&D increase drivers in Q3: +$1.4M EDG-15400 Phase 1 initiation, +$0.9M EDG-7500 clinical work, +$0.5M sevasemten Becker activities, +$0.9M professional fees/other research, +$0.2M manufacturing .

Balance Sheet

MetricQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$436.387 $593.992 $563.340
Total Assets ($USD Millions)$454.391 $613.334 $583.466
Liabilities ($USD Millions)$24.672 $24.263 $24.819
Stockholders’ Equity ($USD Millions)$429.719 $589.071 $558.647

Estimates Comparison (S&P Global)

MetricQ3 2025 ConsensusQ3 2025 Actual
EPS ($USD)-$0.3993*-$0.39
Revenue ($USD Millions)$0.0*n/a (no product revenue)

Values marked with * are retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CIRRUS-HCM Phase 2 program updateQ4 2025“Expect to provide update in Q4 2025” “On track to share a program update in Q4 2025” Maintained
CIRRUS-HCM more comprehensive dataH1 2026n/a“More comprehensive data expected in H1 2026” New
GRAND CANYON (Becker) toplineQ4 2026“On track for topline Q4 2026” “Expects to report topline in Q4 2026” Maintained
EDG-15400 Phase 1 status2025–H1 2026“Expect to begin dosing in Q3 2025” “Currently dosing healthy adults; topline in H1 2026” Updated
Duchenne Phase 3 initiation2026“Meet FDA in Q4 2025 to discuss Phase 3 design” “Plans to initiate pivotal study in 2026” Updated
Becker commercial readinessOngoing“Building commercial infrastructure for potential U.S. launch” “Building commercial infrastructure to support potential launch” Maintained

Earnings Call Themes & Trends

Note: An earnings call transcript was not available in the document catalog for Q3 2025.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
Commercial readiness (Becker)Building infrastructure; funding secured via $200M offering Continuing to build commercial infrastructure ahead of potential launch Strengthening
Becker (MESA/GRAND CANYON)MESA 99% enrolled; Becker stabilization vs natural history MESA continues enrolling nearly all eligible; GRAND CANYON 175 adults, topline Q4 2026 Stable/advancing
Duchenne (LYNX/FOX)Encouraging top-line data; 10mg dose; FDA meeting planned Q4 2025 Plan to meet FDA; pivotal study in 2026 Advancing toward registrational design
HCM (EDG-7500 CIRRUS)Positive top-line Parts B/C; Part D read in 2H 2025 On track for Q4 2025 program update; more comprehensive data H1 2026 Ongoing; timelines clarified
Heart Failure (EDG-15400)IND timing and initiation plans in 2025 Phase 1 dosing underway; topline H1 2026 Advancing
Community engagementActive presence at medical/patient forums WMS and cardiology/heart failure conferences; investor events scheduled Continued outreach

Management Commentary

  • “Planning for success in GRAND CANYON, we are building the commercial infrastructure to support a potential launch of sevasemten in Becker… actively developing Phase 3 trial designs in HCM and Duchenne” — Kevin Koch, Ph.D., President & CEO .
  • EDG-7500 “is on track to share a program update in the fourth quarter of 2025, with more comprehensive data expected in the first half of 2026” .
  • “EDG-15400… currently being dosed in healthy adults… topline results… in the first half of 2026” .

Q&A Highlights

  • Not applicable; no Q3 2025 earnings call transcript was available in the document catalog.

Estimates Context

  • EPS landed slightly better than consensus: -$0.39 vs -$0.3993, essentially in line as OpEx increased with pipeline progress but interest income provided offset; Street likely views this as neutral pending CIRRUS-HCM update and FDA interactions on Duchenne *.
  • Revenue remains n/a with consensus at $0.0, consistent with the company’s pre-commercial status *.
  • Near-term estimate revisions should reflect higher R&D tied to EDG-15400 Phase 1, CIRRUS-HCM activities, and Becker roll-overs noted in management’s expense bridges .

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Balance sheet strength ($563.3M cash) funds runway through key 2025–2026 milestones (CIRRUS update in Q4 2025; GRAND CANYON topline Q4 2026; EDG-15400 Phase 1 topline H1 2026) .
  • The Becker program remains the principal commercial driver; continued MESA stabilization and GRAND CANYON’s power for NSAA difference support potential value inflection with regulatory engagement .
  • EDG-7500’s HCM dataset maturation is a 2025 catalyst; more comprehensive readout in H1 2026 may shape Phase 3 design and competitive positioning .
  • Duchenne strategy is coalescing around a 10mg dose and Phase 3 initiation in 2026 post FDA discussions; consider scenarios for study scope and endpoints .
  • EPS was in line/slightly better than consensus; trading likely hinges on clinical narrative rather than near-term P&L given no product revenue * .
  • CFO transition announced Nov. 10 (Michael Nofi appointed CFO) underscores focus on commercialization readiness and financial operations scaling .
  • Near-term positioning: watch Q4 2025 events and investor conference commentary; medium-term thesis rests on Becker approval pathway and HCM/Duchenne Phase 3 momentum .