Editas Medicine Files 8-K Report

TL;DR

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

AI Summary

On June 14, 2024, Editas Medicine, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This filing indicates Editas Medicine is providing updated information to the SEC, which could include material disclosures relevant to investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard SEC filing notification and does not contain specific material events or financial data that would indicate a high risk.

Key Players & Entities

• Editas Medicine, Inc. (company) — Registrant
• June 14, 2024 (date) — Date of earliest event reported
• 11 Hurley Street (address) — Principal Executive Offices
• Cambridge, Massachusetts (location) — Principal Executive Offices City and State

FAQ

Key Financial Figures

• $0.0001 — ange on which registered Common Stock, $0.0001 par value per share EDIT The Nasdaq Sto

Filing Documents

• edit-20240614.htm (8-K) — 35KB
• ex991.htm (EX-99.1) — 30KB
• ex992.htm (EX-99.2) — 28KB
• image_0.jpg (GRAPHIC) — 10KB
• 0001650664-24-000078.txt ( ) — 245KB
• edit-20240614.xsd (EX-101.SCH) — 2KB
• edit-20240614_lab.xml (EX-101.LAB) — 21KB
• edit-20240614_pre.xml (EX-101.PRE) — 12KB
• edit-20240614_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On June 14, 2024, Editas Medicine, Inc. (the "Company") issued two press releases, one titled "Editas Medicine Reports New Safety and Efficacy Data from the RUBY Trial of Reni-cel in 18 Patients with Sickle Cell Disease, Presented at the European Hematology Association (EHA) Annual Congress," a copy of which is furnished as Exhibit 99.1 hereto, and the other titled "Editas Medicine Announces New Safety and Efficacy Data from the EdiTHAL Trial of Reni-cel in 7 Patients with Transfusion-dependent Beta Thalassemia, Presented at the European Hematology Association (EHA) Annual Congress," a copy of which is furnished as Exhibit 99.2 hereto. The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is intended to be furnished and 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 filing.

01 Other Events

Item 8.01 Other Events. On June 14, 2024, the Company announced new safety and efficacy data in 18 patients treated with renizgamglogene autogedtemcel ("reni-cel"; formerly known as EDIT-301) in the Company's Phase 1/2/3 clinical trial of reni-cel for the treatment of severe sickle cell disease ("SCD"), which is referred to as the RUBY trial. The data provided was as of a May 8, 2024 data cutoff date. The Company also announced on June 14, 2024, new safety and efficacy data in seven patients treated with reni-cel in the Company's Phase 1/2 clinical trial of reni-cel for the treatment of transfusion-dependent beta thalassemia ("TDT"), which is referred to as the EdiTHAL trial. The data provided was as of a May 8, 2024 data cutoff date. RUBY Clinical Data Update In the RUBY clinical trial, all 18 patients are free of vaso-occlusive events since reni-cel infusion with follow-up ranging from 2.4 to 22.8 months. Patients demonstrated early normalization of total hemoglobin ("Hb") with a mean within the normal range at more than 14g/dL and rapid and sustained improvements in fetal hemoglobin ("HbF") well above levels of over 40%. Across patients with at least six months follow-up, at month six, the mean total Hb was 14.3 g/dL for nine patients with a mean HbF of 48.5% for 10 patients. The mean percentage of F-cells increased early and were sustained at over 90% from month four through subsequent follow-ups for all 12 patients with at least four months follow-up. Mean corpuscular fetal hemoglobin of HbF-containing red cells (F-cells) was sustained above the anti-sickling threshold of 10 pg/F-cell by month three after reni-cel infusion for all 14 patients with at least three months follow-up. All patients in the RUBY trial showed sustained high levels of editing in the HBG1 and HBG2 promoter regions. Markers of hemolysis have been normalized or improved in patients treated with reni-cel. Reni-cel was well-tolerated and demonstrated a safety profile consistent with m

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by the Company on June 14, 2024* 99.2 Press release issued by the Company on June 14, 2024* 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) * This exhibit shall be deemed to be furnished and not filed.

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. EDITAS MEDICINE, INC. Date: June 14, 2024 By: /s/ Erick Lucera Erick Lucera Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR