Roche Acquires Entrada Therapeutics for $4.3 Billion

TL;DR

Roche buying Entrada for $4.3B to get their DMD drug!

AI Summary

Entrada Therapeutics, Inc. announced on June 24, 2024, that it has entered into a definitive agreement to be acquired by Roche for approximately $4.3 billion. The acquisition aims to advance Entrada's ENTR-001 program for Duchenne muscular dystrophy and other rare neuromuscular diseases.

Why It Matters

This significant acquisition by a major pharmaceutical company like Roche highlights the potential of Entrada's novel therapeutic approach and could accelerate the development of treatments for rare neuromuscular diseases.

Risk Assessment

Risk Level: medium — The acquisition is subject to customary closing conditions, including regulatory approvals, which introduces a degree of uncertainty.

Key Numbers

• $4.3B — Acquisition Value (Total amount Roche is paying for Entrada Therapeutics)

Key Players & Entities

• Entrada Therapeutics, Inc. (company) — Company filing the report and being acquired
• Roche (company) — Acquiring company
• $4.3 billion (dollar_amount) — Acquisition price
• June 24, 2024 (date) — Date of the definitive agreement
• ENTR-001 (drug_candidate) — Key therapeutic program
• Duchenne muscular dystrophy (disease) — Target indication for ENTR-001

FAQ

Key Financial Figures

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

Filing Documents

• tm2417848d2_8k.htm (8-K) — 57KB
• tm2417848d2_ex99-1.htm (EX-99.1) — 19KB
• tm2417848d2_8kimg004.jpg (GRAPHIC) — 54KB
• tm2417848d2_8kimg005.jpg (GRAPHIC) — 51KB
• tm2417848d2_ex99-1img001.jpg (GRAPHIC) — 4KB
• 0001104659-24-074078.txt ( ) — 540KB
• trda-20240624.xsd (EX-101.SCH) — 3KB
• trda-20240624_lab.xml (EX-101.LAB) — 33KB
• trda-20240624_pre.xml (EX-101.PRE) — 22KB
• tm2417848d2_8k_htm.xml (XML) — 4KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On June 24, 2024, Entrada Therapeutics, Inc. (the "Company") issued a press release providing an update on ENTR-601-44, its most advanced product candidate being developed for patients with Duchenne muscular dystrophy ("DMD") . The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01. Other Events

Item 8.01. Other Events. Update on ENTR-601-44 On June 24, 2024, the Company announced positive preliminary data from its Phase 1 clinical trial of ENTR-601-44, its most advanced product candidate being developed for patients with DMD. The data announced is based upon data collected to date, is aggregated based upon the placebo and study drug groups and does not include urinary biomarkers for its 6 mg/kg cohort. The primary objective of the Company's Phase 1 clinical trial was to evaluate the safety and tolerability of a single dose of ENTR-601-44. The trial also evaluated pharmacokinetics and target engagement, as measured by exon skipping in the skeletal muscle. The trial included a total of 32 healthy male volunteers across four cohorts, with each cohort consisting of six participants receiving ENTR-601-44 and two participants receiving a placebo control. The doses administered across the cohorts were 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg ("Cohort 3") and 6 mg/kg ("Cohort 4"). Safety and Tolerability There were no serious adverse events, no drug-related adverse events, and no clinically significant changes or trends noted in vital signs, electrocardiograms ("ECGs"), physical exams or laboratory assessments observed in the trial. More specifically, there were no severe treatment emergent adverse events ("TEAEs") and no TEAEs leading to discontinuation reported in the study in any cohort. In addition, there were no clinically significant changes from baseline values observed in renal function-related findings (BUN, Cr, CysC, Mg, eGFR) or in creatine kinase. Further, no clinically significant lab values in hematology, blood chemistry and urinalysis were observed, no changes in urinary biomarkers through the first three cohorts (does not include urinary biomarker data from Cohort 4), no clinically significant changes from baseline recordings noted on ECGs for all four cohorts, and no clinically significant changes from baseline recordings noted on vitals and physica

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than Company's strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of the Company's approach and its ability to provide a potential treatment for patients, the translatability of the preliminary ENTR-601-44-101 data to the complete data set, expectations regarding the starting dose for the Company's planned Phase 2 clinical trial for ENTR-601-44, expectations regarding significant accumulation of exon skipping and dystrophin production in patients, expectations regarding improvement in functional outcomes for patients after multiple doses of ENTR-601-44, expectations regarding the importance of endosomal escape to therapeutic index optimization, expectations regarding the timing of regulatory filings for the planned Phase 2 clinical trials for ENTR-601-44 and ENTR-601-45 in the fourth quarter of 2024, and ENTR-601-50 in 2025, the ability to recruit for and complete a global Phase 2 trial for ENTR-601-44, ENTR-601-45 and ENTR-601-50, the potential of the Company's EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option and EEV platform, and the continued development and advancement of ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of Duchenne and the partnered product VX-670 for the treatment of myotonic dystrophy type 1, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," or "would," or the negative of these terms, or other comparable

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release issued by Entrada Therapeutics, Inc. on June 24, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE 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. Entrada Therapeutics, Inc. Date: June 24, 2024 /s/ Dipal Doshi Dipal Doshi Chief Executive Officer

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View this 8-K filing on SEC EDGAR