Edgewise Therapeutics, Inc. (EWTX)·Q2 2025 Earnings Summary

Executive Summary

• EPS beat: Q2 2025 diluted EPS was -$0.34 vs Wall Street consensus of -$0.42, a positive delta of +$0.08; revenue remained $0.00. The beat was driven by lower R&D sequentially and higher interest income . EPS consensus values retrieved from S&P Global.*
• Cash, cash equivalents and marketable securities ended Q2 at $593.99M, bolstered by the April $200M offering; OpEx fell to $42.61M from $45.96M in Q1, narrowing net loss to $36.12M from $40.80M .
• Program momentum: FDA Type C meeting provided a clear path toward registration for sevasemten in Becker; GRAND CANYON (175 adult Becker participants) remains on track for topline data in Q4 2026; LYNX/FOX Duchenne Phase 2 readouts identified 10 mg dose for Phase 3 discussion in Q4 2025 .
• Stock reaction catalyst: shares rallied pre-market following the EPS beat and positive trial updates, with media noting a >5% pre-market gain on release day .

What Went Well and What Went Wrong

What Went Well

• EPS beat and sequential P&L improvement: net loss narrowed to $36.1M (-$0.34 per share) vs $40.8M (-$0.43) in Q1, aided by a $3.2M reduction in R&D and higher interest income .
• Becker program momentum: MESA open-label extension showed sustained disease stabilization in NSAA up to three years; FDA Type C meeting outlined a registration path and endorsed NSAA for traditional approval. “We’re advancing… to support a potential U.S. launch of sevasemten in Becker” — Kevin Koch, CEO .
• EDG-7500 in HCM: Phase 2 (Parts B/C) demonstrated rapid, clinically meaningful LVOT gradient reductions and improvements in KCCQ without LVEF declines; investigators expressed enthusiasm for the diastolic function profile .

What Went Wrong

• Still pre-revenue: the company reiterated risks tied to having “not having generated any revenue to date,” limiting near-term financial optionality .
• FDA decision complexity: Agency indicated CANYON alone is insufficient for accelerated approval, escalating reliance on GRAND CANYON as a single adequate well-controlled study (Q4 2026 readout) .
• Continued operating losses: total operating expenses of $42.61M, with G&A steady and R&D still elevated across programs; while improving sequentially, absolute cash burn remains material .

Financial Results

P&L and Balance Sheet Summary (sequential and prior quarter)

Revenue and EPS vs Estimates

Values with asterisks were retrieved from S&P Global.*

KPIs

Guidance Changes

Earnings Call Themes & Trends

Note: A Q2 2025 earnings call transcript was not available in our corpus or via internet sources; themes below reflect management communications across quarterly releases and investor events.

Management Commentary

• “With strong funding in place, we’re advancing our skeletal and cardiac muscle programs and building the commercial infrastructure… to support a potential U.S. launch of sevasemten in Becker.” — Kevin Koch, President & CEO .
• “We are thrilled with the tremendous excitement… and their unwavering commitment to our ongoing pivotal program… We are well positioned to deliver the first ever therapy for individuals with Becker muscular dystrophy.” — Joanne Donovan, CMO .
• “Strong improvements in diastolic function… overall symptom relief with little to no effect on systolic function… reinforces my enthusiasm” — Dr. Anjali T. Owens, CIRRUS-HCM investigator .

Q&A Highlights

• No Q2 2025 earnings call transcript was available; management clarifications from press releases and investor updates include: FDA confirmed NSAA as a clinically meaningful endpoint for traditional approval in Becker; CANYON-alone deemed insufficient for accelerated approval (increasing reliance on GRAND CANYON) . Duchenne Phase 2 dose selection converged on 10 mg with Phase 3 design meeting targeted in Q4 2025 . CIRRUS-HCM Part D update timing narrowed to Q4 2025 .

Estimates Context

• EPS: Q2 2025 actual -$0.34 vs S&P Global consensus -$0.42; a beat of +$0.08, supported by lower R&D expenses (-$3.2M q/q) and higher interest income (+$1.33M q/q) . EPS consensus values retrieved from S&P Global.*
• Revenue: Actual $0.00 with consensus $0.00, consistent with pre-revenue status . Revenue consensus values retrieved from S&P Global.*
• Implications: Near-term EPS estimates may modestly narrow losses given OpEx discipline and interest carry; broader estimate revisions hinge on regulatory milestones (Becker) and clinical readouts (HCM Part D, Duchenne Phase 3 planning) .

Key Takeaways for Investors

• EPS beat and sequential improvement signal opex discipline and cash yield tailwinds; cash of ~$594M supports multiple late-stage programs .
• Regulatory clarity for Becker (NSAA endpoint) and FDA feedback elevate GRAND CANYON’s Q4 2026 readout as the binary valuation pivot; ongoing MESA data can help de-risk trajectory .
• Duchenne advances: 10 mg dose selected, Phase 3 design meeting in Q4 2025; longer-term open-label extension to strengthen dataset .
• HCM catalyst: CIRRUS-HCM Part D 12-week update in Q4 2025; earlier data showed robust LVOT gradient reductions and KCCQ gains without LVEF compromise .
• Financing strength: April $200M raise broadened institutional support and extended runway; expect continued interest income to partially offset burn .
• Short-term trading: Expect event-driven volatility around upcoming clinical/regulatory disclosures (Q4 2025 updates, FDA meetings); EPS prints can surprise positively if OpEx trends persist .
• Medium-term thesis: Pre-revenue biotech with two late-stage assets (sevasemten, EDG-7500); core upside tied to Becker approval path and HCM Phase 3 initiation, with cash runway to reach key inflections .

Values with asterisks were retrieved from S&P Global.*