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Edgewise Therapeutics, Inc. (EWTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered continued R&D execution with cash and marketable securities of $470.2M, net loss of $39.7M, and diluted EPS of $0.42 loss; OpEx rose sequentially on trial activity in CIRRUS-HCM and Becker programs .
  • GRAND CANYON Becker pivotal cohort enrollment was completed in February 2025 at 175 adults, significantly above prior ~120 target, with data expected in Q4 2026; this raises program scale and potential regulatory momentum .
  • CANYON Phase 2 topline (Dec 2024) met the CK primary endpoint and showed functional stabilization trends on NSAA; safety was clean, supporting a path to regulatory engagement in 1H 2025 and underpins GRAND CANYON powering assumptions .
  • Timing guidance mixed: CIRRUS-HCM 28-day data remained on track for Q1 2025, while LYNX/FOX Duchenne readouts shifted to 1H 2025 from earlier expectations; investors should watch near-term catalysts and any regulatory feedback .
  • No Q4 earnings call transcript was available in the document catalog; analysis is based on the 8‑K and press releases. Wall Street consensus estimates via S&P Global were unavailable due to a tool limit, so beat/miss vs. estimates cannot be assessed [functions.GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • CANYON Phase 2 achieved the primary endpoint (CK reduction: 28% average decrease vs. placebo over months 6–12; p=0.02) and showed NSAA stabilization trends, with robust biomarker reductions (TNNI2 down 77%; p<0.001), and clean safety, strengthening the Becker thesis .
  • GRAND CANYON enrollment completed at 175 adults across 51 sites in 12 countries, reflecting strong community engagement and expanding the evidence base; data expected Q4 2026 .
  • Management affirmed near-term EDG‑7500 CIRRUS‑HCM data timing and highlighted prior Part A single-dose gradient reductions without meaningful LVEF changes, sustaining cardiovascular program momentum .

Quote: “Closing out 2024 with positive Phase 2 CANYON results, completing enrollment in GRAND CANYON and advancing CIRRUS-HCM, we are well positioned in 2025…” — Kevin Koch, Ph.D., President & CEO .

What Went Wrong

  • LYNX and FOX Duchenne timelines shifted to 1H 2025 from prior expectations (LYNX previously guided for Q4 2024), suggesting execution or data analysis timing stretch in pediatric cohorts .
  • Sequential OpEx increase (+$4.2M q/q) with higher R&D driven by personnel and clinical activities (CIRRUS‑HCM, GRAND CANYON, MESA), modestly widening net loss q/q; cash declined to $470.2M from $492.5M .
  • No Q4 earnings call transcript accessible; limits insight into Q&A clarifications on regulatory strategy and timelines. Additionally, estimates (EPS/revenue) from S&P Global were not retrievable, precluding beat/miss assessment [functions.GetEstimates error] .

Financial Results

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Research and Development ($USD Millions)$27.7 $30.7 $32.2 $36.4
General & Administrative ($USD Millions)$6.2 $7.4 $8.2 $9.2
Total Operating Expenses ($USD Millions)$33.9 $38.1 $40.4 $45.5
Interest Income ($USD Millions)$3.7 $6.6 $6.3 $5.9
Net Loss ($USD Millions)$(30.1) $(31.5) $(34.1) $(39.7)
Diluted EPS ($USD)$(0.47) $(0.34) $(0.36) $(0.42)
Weighted Avg Shares (Millions)64.8 93.5 93.8 94.7
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$318.4 $511.8 $492.5 $470.2
Revenue ($USD Millions)Not reported; pre‑revenue Not reported; pre‑revenue Not reported; pre‑revenue Not reported; pre‑revenue

Notes:

  • The company states it has not generated revenue to date; margins are not applicable without revenue .

Segment breakdown: Not applicable; company is pre‑commercial with no reported revenue segments .
KPIs: See program status table below.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CIRRUS‑HCM 28‑day topline (EDG‑7500)Q1 2025“Report CIRRUS‑HCM 28‑day data in Q1 2025” “On track to report CIRRUS‑HCM 28‑day data in Q1 2025” Maintained
LYNX Phase 2 Duchenne dataPreviously Q4 2024“Report LYNX data in Q4 2024” “Report LYNX data in 1H 2025” Lowered/Delayed
FOX Phase 2 Duchenne dataNot specified previouslyOngoing; enthusiasm/over‑enrollment noted “Report FOX data in 1H 2025” Provided timeline (new)
GRAND CANYON Becker enrollment2024–Q1 2025“Recruit ~120 adults; global pivotal cohort” “Enrollment completed Feb 2025 at 175 adults; data Q4 2026” Raised scope; Accelerated completion

No financial guidance (revenue, margins, OpEx targets) was provided; messaging focused on clinical timelines and program milestones .

Earnings Call Themes & Trends

No Q4 earnings call transcript was found; themes compiled from Q2/Q3/Q4 releases.

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
Becker (CANYON and GRAND CANYON)CANYON over‑enrolled; data expected Q4 2024; GRAND CANYON ~120 target CANYON met CK primary endpoint with NSAA stabilization trends and biomarker reductions; GRAND CANYON enrollment completed at 175 adults Strengthening clinical signal; expanded pivotal scope
Duchenne (LYNX/FOX)LYNX Q4 2024 data; FOX over‑enrollment enthusiasm LYNX and FOX readouts shifted to 1H 2025; Phase 3 strategy to be formed based on collective dose finding Timing slippage; strategy consolidation
HCM (EDG‑7500 CIRRUS‑HCM)Part A single‑dose: LVOT gradient reductions without LVEF changes; 28‑day data Q1 2025 “On track” for 28‑day Q1 2025; 12‑week data expected 2H 2025 Execution on plan; upcoming catalysts
Regulatory/LegalDesignations and trial plans; no issues noted Statement on FDA warning letter to external PI (unrelated to Edgewise trials) with site audits supporting data integrity External noise addressed; data integrity asserted
R&D Execution/OpExR&D ramp with clinical enrollment and manufacturing; sequential increases Further R&D increase q/q tied to CIRRUS‑HCM and Becker trials Investment rising with trial intensity

Management Commentary

  • “Closing out 2024 with positive Phase 2 CANYON results, completing enrollment in GRAND CANYON and advancing CIRRUS‑HCM, we are well positioned in 2025…” — Kevin Koch, Ph.D., President & CEO .
  • “We are very encouraged by the CANYON results in Becker… seeing evidence of preservation of function in Becker patients.” — Joanne Donovan, Ph.D., M.D., Chief Medical Officer .
  • “This landmark study presents compelling biomarker data and promising signals that suggest the potential for functional stabilization…” — Craig M. McDonald, M.D., Principal Investigator (CANYON/GRAND CANYON) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in the catalog or via search; therefore, no Q&A content could be reviewed [functions.ListDocuments earnings-call-transcript=0] .

Estimates Context

  • Wall Street consensus EPS and revenue for Q4 2024 could not be retrieved due to S&P Global daily request limit; as a result, beat/miss vs consensus is unavailable for this recap [functions.GetEstimates error].
  • Given no revenue and rising R&D to support pivotal and Phase 2 programs, estimates likely reflect continued losses and cash utilization; revisions may incorporate: higher OpEx from program expansion (e.g., GRAND CANYON enrollment size), and timing shifts for LYNX/FOX readouts impacting near-term news flow .

Program KPIs and Operational Status

KPIStatus/ValueSource
Cash, cash equivalents & marketable securities$470.2M (Dec 31, 2024)
Net loss / Diluted EPS$(39.7)M / $(0.42) (Q4 2024)
R&D / G&A$36.4M / $9.2M (Q4 2024)
CANYON Phase 2 (Becker)Primary endpoint met (CK); NSAA stabilization trend; safety clean
GRAND CANYON pivotal (Becker)Enrollment completed at 175 adults; data Q4 2026
LYNX (Duchenne)Data expected 1H 2025; informs Phase 3 design
FOX (Duchenne, post gene therapy)Data expected 1H 2025
CIRRUS‑HCM (EDG‑7500)28‑day data Q1 2025; 12‑week data 2H 2025; Part A gradient reduction without LVEF impact

Key Takeaways for Investors

  • Near-term catalysts: CIRRUS‑HCM 28‑day (Q1 2025) and LYNX/FOX (1H 2025) will shape medium-term narrative; positive readouts can de-risk the cardiovascular and Duchenne programs .
  • Becker thesis strengthened by CANYON biomarker efficacy and functional stabilization trends, plus GRAND CANYON scale-up (175 adults) and completed enrollment; regulatory engagement planned in 1H 2025 .
  • Watch timing risk: LYNX slipped from Q4 2024 to 1H 2025; monitor whether FOX/LYNX remain on revised schedule and whether Phase 3 design clarity emerges promptly .
  • Operating leverage: OpEx rising with trial intensity; cash remains robust, but sequential declines reflect R&D cadence; expect continued investment until pivotal/Phase 2 completions .
  • Regulatory optics: Company addressed external FDA warning letter to an investigator site, asserting Edgewise trial data integrity; continued vigilance advisable .
  • Absence of transcript and consensus data: Without Q4 Q&A or S&P consensus, price-relevant narrative hinges on upcoming data releases; traders should position around event dates and potential regulatory updates [functions.GetEstimates error].
  • Medium-term thesis: A successful GRAND CANYON readout (NSAA) in Q4 2026 could enable first Becker therapy; EDG‑7500’s profile (fixed-dose potential, gradient reduction without LVEF impact) could carve a differentiated HCM position if multi-dose data sustain efficacy/safety .