Edgewise Therapeutics Files 8-K

Ticker: EWTX · Form: 8-K · Filed: Dec 16, 2024 · CIK: 1710072

Edgewise Therapeutics, Inc. 8-K Filing Summary
FieldDetail
CompanyEdgewise Therapeutics, Inc. (EWTX)
Form Type8-K
Filed DateDec 16, 2024
Risk Levellow
Pages6
Reading Time7 min
Key Dollar Amounts$0.0001
Sentimentneutral

Sentiment: neutral

Topics: sec-filing, 8-k

Related Tickers: EDGW

TL;DR

EDGW filed an 8-K, likely containing important updates for investors.

AI Summary

On December 16, 2024, Edgewise Therapeutics, Inc. filed an 8-K report. The filing primarily concerns Regulation FD disclosures and other events, along with financial statements and exhibits. No specific material events or financial figures were detailed in the provided excerpt.

Why It Matters

This filing indicates Edgewise Therapeutics is making disclosures to the SEC, which could contain material information for investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard SEC filing notification and does not contain specific financial or operational risks.

Key Players & Entities

  • Edgewise Therapeutics, Inc. (company) — Registrant
  • December 16, 2024 (date) — Date of earliest event reported

FAQ

What is the primary purpose of this 8-K filing for Edgewise Therapeutics, Inc.?

The filing is for Regulation FD disclosures, other events, and financial statements and exhibits.

When was the earliest event reported in this filing?

The earliest event reported was on December 16, 2024.

What is the principal executive office address for Edgewise Therapeutics, Inc.?

The address is 1715 38th St., Boulder, CO 80301.

What is the telephone number for Edgewise Therapeutics, Inc.?

The telephone number is (720) 262-7002.

What is the state of incorporation for Edgewise Therapeutics, Inc.?

The state of incorporation is Delaware.

Filing Stats: 1,759 words · 7 min read · ~6 pages · Grade level 12.7 · Accepted 2024-12-16 17:25:51

Key Financial Figures

  • $0.0001 — nge on which registered Common Stock, $0.0001 par value per share EWTX The Nasdaq

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 16, 2024, Edgewise Therapeutics, Inc. (the " Company ") issued a press release announcing positive topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy. The press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. On December 16, 2024, the Company also posted a presentation to its Investor Relations website ( https://investors.edgewisetx.com). A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On December 16, 2024, the Company announced positive topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy. Overview of CANYON and Clinical Results CANYON, the largest interventional Becker muscular dystrophy trial, is a Phase 2, double-blind, randomized, placebo-controlled study to investigate the effect of sevasemten on the safety, pharmacokinetics, biomarkers, and functional measures of participants (NCT05291091). The trial was not powered for the functional endpoints. Forty adults and 29 adolescents with Becker muscular dystrophy were enrolled. This study had a 4-week screening period, a 12-month treatment period, followed by a 4-week follow-up period. The adult participants were randomized to sevasemten or placebo in a 3:1 ratio. The adolescent participants were randomized in a 2:1 ratio to sevasemten or placebo and were assessed for safety and tolerability. The data analysis included the complete adult safety population of 40 individuals. There was a notable imbalance between adult participants in the sevasemten and placebo groups with the sevasemten group having more advanced disease at baseline based on all functional measures and MRI. Primary Endpoint: The primary endpoint to assess the efficacy of sevasemten compared to placebo was change from baseline in creatine kinase (" CK ") over the treatment period for adults. The results demonstrated a significant change from baseline in CK in the sevasemten-treated group (difference vs. placebo, 28% average decrease over months 6 through 12; p=0.02). Key Secondary Endpoint: The key secondary endpoint was the change from baseline in NSAA total score in adults at month 12. North Star Ambulatory Assessment (" NSAA ") is a scale commonly used to rate motor function. The between-group difference was 1.1 points, favoring sevasemten; p=0.16 across all adult participants. NSAA remained stable over time in the sevasemten treatment group, sim

forward-looking statements, except as required by law

forward-looking statements, except as required by law.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release, dated December 16, 2024 . 99.2 Presentation, dated December 16, 2024 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. EDGEWISE THERAPEUTICS, INC. By: /s/ Behrad Derakhshan, Ph.D. Behrad Derakhshan, Ph.D. Chief Business Officer Date: December 16, 2024

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