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Edgewise Therapeutics, Inc. (EWTX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally solid with key R&D milestones: positive four‑week Phase 2 CIRRUS‑HCM data for EDG‑7500 (robust LVOT‑G and NT‑proBNP reductions with KCCQ improvements) and timelines reaffirmed for sevasemten readouts (LYNX/FOX in Q2’25) and CIRRUS‑HCM Part D in 2H’25 .
  • Balance sheet fortified: $436.4M cash/cash equivalents/marketable securities at 3/31 plus $188M net proceeds from April offering; pro‑forma cash >$624M to fund pivotal programs (Becker, Duchenne, HCM) .
  • Financials in line for a pre‑revenue biotech: net loss ($40.8M) and EPS ($0.43) modestly widened q/q on higher R&D; EPS was essentially in line with S&P Global consensus (−$0.43 vs −$0.435*) .
  • Near‑term stock catalysts: Duchenne LYNX/FOX data in Q2’25; CIRRUS‑HCM Part D (12‑week) data in 2H’25; regulatory dialogue on sevasemten in Becker ongoing .

What Went Well and What Went Wrong

What Went Well

  • EDG‑7500 four‑week data delivered clinically meaningful improvements without systolic impairment: up to 71% mean LVOT‑G reduction (rest) and 58% (Valsalva), 62% mean NT‑proBNP reduction, +23 mean KCCQ‑OSS at 100 mg; no LVEF <50% observed .
  • Strategic financing de‑risked execution: ~$200M gross / ~$188M net raised in April, supporting Phase 3 preparations across sevasemten and EDG‑7500; pro‑forma cash >$624M .
  • Program momentum: GRAND CANYON enrollment completed (175 adults); MESA OLE retention at 99% of eligibles; LYNX/FOX Duchenne data and CIRRUS‑HCM Part D readout timelines reiterated .
  • CEO tone constructive: “positive top‑line results from CIRRUS‑HCM… $200M offering enabling… commercial readiness for potential U.S. approval of sevasemten in Becker… Phase 3 in Duchenne and HCM” .

What Went Wrong

  • Operating spend drifted higher: R&D rose to $36.8M (from $36.4M in Q4), contributing to a slightly larger net loss ($40.8M vs $39.7M in Q4) and a $0.01 sequential EPS step‑down to ($0.43) .
  • Lower interest income q/q ($5.16M vs $5.88M) modestly offset Opex but fell q/q amid declining cash balances pre‑offering .
  • Safety signals to monitor: two serious AF events requiring cardioversion in EDG‑7500 Parts B/C (rates described as within Phase 2 ranges for HCM MIs); one discontinuation for dizziness .

Financial Results

Income Statement and Cash Trends (USD millions, except per‑share)

MetricQ1 2024Q3 2024Q4 2024Q1 2025
R&D Expense$27.694 $32.222 $36.370 $36.757
G&A Expense$7.059 $8.210 $9.170 $9.202
Total Operating Expenses$34.753 $40.432 $45.540 $45.959
Interest Income$6.228 $6.303 $5.878 $5.161
Net Loss($28.525) ($34.129) ($39.662) ($40.798)
Net Loss per Share($0.33) ($0.36) ($0.42) ($0.43)
Cash, Equivalents & Marketable Securities (period‑end)$532.759 $492.536 $470.170 $436.387
Pro‑forma Cash (incl. $188M net proceeds on 4/3/25)———$624.4

Notes: Company is pre‑revenue (no product sales reported) .

Actual vs S&P Global Consensus – Q1 2025

MetricQ1 2025 ActualQ1 2025 ConsensusSurprise
Revenue ($M)$0.0 (no revenue reported) $0.0*In line*
EPS (Primary)($0.43) ($0.435)*~+$0.005 (in line)*

Values marked with * retrieved from S&P Global.

KPIs and Program Datapoints

KPIQ3 2024Q4 2024Q1 2025Notes
GRAND CANYON enrollment (Becker)Ongoing Completed; 175 adults 175 adults Pivotal cohort (18‑month); data Q4’26
MESA OLE retention (Becker)99% of eligibles 99% of eligibles 99% of eligibles Long‑term sevasemten access
EDG‑7500 LVOT‑G red. (rest, 100 mg)Single dose data positive —71% mean at 4 weeks Obstructive HCM (Part B)
EDG‑7500 LVOT‑G red. (Valsalva, 100 mg)Single dose data positive —58% mean at 4 weeks Obstructive HCM (Part B)
EDG‑7500 NT‑proBNP red. (100 mg)64% (single‑dose 200 mg cohort) —62% mean at 4 weeks (obstructive); 42% (non‑obstructive) Biomarker improvements
EDG‑7500 KCCQ‑OSS (100 mg)——+23 mean (4 weeks) Symptom/function measure
EDG‑7500 SafetyNo LVEF <50% across exposures —No LVEF <50%; AF events incl. 2 SAEs Part B/C 4‑week data

Guidance Changes

No formal financial guidance (revenue/margins/EPS) was issued. The company reiterated/updated clinical and regulatory timelines as below.

Metric/ProgramPeriodPrevious GuidanceCurrent GuidanceChange
Sevasemten – LYNX (Duchenne)Data timing1H’25 Q2’25 Maintained/narrowed window
Sevasemten – FOX (Duchenne, post‑gene therapy)Data timing1H’25 Q2’25 Maintained/narrowed window
Sevasemten – Becker regulatoryInteractionEngage FDA in 1H’25 Ongoing marketing authorization strategy discussions Progressing as planned
EDG‑7500 – CIRRUS‑HCM Part DData timing2H’25 2H’25 (unchanged) Maintained
EDG‑7500 – Phase 3StartPlan initiation 2026 (implied) 1H’26 planned Clarified timing

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not available in our source set; themes below derive from company releases across Q3’24–Q1’25.

TopicQ3 2024 (prior‑2)Q4 2024 (prior‑1)Q1 2025 (current)Trend
Product performance (EDG‑7500)Positive single‑dose Part A and Phase 1 safety; strong LVOT‑G/NT‑proBNP signals without LVEF decline Teed‑up 28‑day data in Q1’25 Four‑week data: robust LVOT‑G, NT‑proBNP and KCCQ gains; tolerability acceptable; no LVEF <50% Improving dataset breadth/consistency
R&D executionCIRRUS‑HCM enrollment ongoing; Duchenne LYNX/FOX advancing GRAND CANYON enrollment completed; LYNX/FOX data 1H’25 LYNX/FOX data Q2’25; Part D in 2H’25 On‑schedule milestones
Regulatory/filing path (Becker)—Plan to engage FDA in 1H’25 FDA marketing authorization strategy discussions ongoing Advancing toward potential filing
Financing/runway—$470.2M cash YE’24 $436.4M at 3/31; +$188M net in April; pro‑forma $624.4M Strengthened liquidity
Patient/community engagementConferences and outreach across HCM/MD communities Continued broad engagement Continued presence at major meetings Sustained

Management Commentary

  • “We’re seeing strong progress across our skeletal and cardiac muscle programs… positive top‑line results from CIRRUS‑HCM and completed a $200 million offering enabling… commercial readiness for a potential U.S. approval of sevasemten in Becker, advancement of a Phase 3 trial in Duchenne, a Phase 3 program in HCM…” — Kevin Koch, President & CEO .
  • “These early data with EDG‑7500 are encouraging, with favorable changes across multiple domains, including robust improvements in KCCQ…” — Dr. Ahmad Masri, OHSU (CIRRUS‑HCM investigator) .
  • “I am particularly encouraged by the strong improvements in diastolic function… with little to no effect on systolic function.” — Dr. Anjali Owens, UPenn (CIRRUS‑HCM investigator) .
  • “We believe EDG‑7500… has the potential to be a significant advancement for patients with HCM…” — Kevin Koch, President & CEO .

Q&A Highlights

  • Not available: A Q1 2025 earnings call transcript could not be located in our document set; no Q&A excerpting possible from primary sources. We will update if a transcript is released in the filings library or investor site.

Estimates Context

  • EPS was essentially in line with S&P Global consensus (Actual −$0.43 vs Consensus −$0.435*); revenue remains $0 as expected for a pre‑commercial biotech (Consensus $0*; Actual $0) .
  • With strong Part B/C HCM data and multiple near‑term readouts, estimate revisions (expense cadence/timing of Phase 3 starts) may shift toward higher 2H’25/2026 R&D as programs scale, partially offset by interest income. No financial guidance provided to anchor Street models .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Execution remains the core story: multiple near‑term clinical readouts (Duchenne LYNX/FOX in Q2’25; HCM Part D in 2H’25) are the primary stock catalysts over the next 1–2 quarters .
  • EDG‑7500 de‑risks with four‑week efficacy and favorable systolic profile; the 12‑week Part D will be pivotal to Phase 3 design and broader efficacy durability narrative .
  • Financing meaningfully extends runway and supports concurrent Phase 3 preparations in Becker, Duchenne, and HCM, reducing overhang from capital needs into key data events .
  • Safety watch item: atrial fibrillation SAEs occurred but were framed as within Phase 2 ranges; continued surveillance in Part D is important for class‑risk benchmarking .
  • Near‑term Street model implications: expenses likely to track upward with trial scaling; EPS sensitivity driven by R&D timing and interest income trajectory; no revenue until approvals .
  • Regulatory pathway for sevasemten in Becker progressing (FDA strategy discussions ongoing); clarity on filing route will be a significant valuation inflection .
  • Monitor conference participation and scientific engagement for incremental data/context while awaiting formal readouts .