Form 8-K

8-K — Editas Medicine, Inc.

Accession: 0001104659-26-065908

Filed: 2026-05-26

Period: 2026-05-25

CIK: 0001650664

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

May 25, 2026

Editas Medicine, Inc.

(Exact Name of Registrant as Specified in its

Charter)

Delaware

001-37687

46-4097528

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

Hurley Street

Cambridge,

Massachusetts

02141

(Address

of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including

area code: (617) 401-9000

(Former Name or Former Address, if Changed Since

Last Report)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction

A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

EDIT

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange

Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ¨

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01 Regulation FD Disclosure.

On May 26, 2026, Editas Medicine, Inc. (the “Company”)

issued a press release titled “Editas Medicine Presents EDIT-401 Preclinical Data Demonstrating Robust Reductions in LDL-C, Lp(a),

and ApoB in Non-Human Primates at the 94th European Atherosclerosis Society Congress”, a copy of which is furnished as Exhibit 99.1

hereto.

The information in this Item 7.01, including Exhibit 99.1 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.

Item 8.01 Other Events.

On May 25, 2026, the Company announced in an oral presentation at the

94th European Atherosclerosis Society (EAS) Congress new preclinical data for EDIT-401, its lead in vivo development

candidate, from preclinical studies in non-human primates (“NHPs”). In the data presented, EDIT-401 achieved robust reductions

in LDL-cholesterol (“LDL-C”), lipoprotein(a) (“Lp(a)”), and apolipoprotein B (“ApoB”). The findings

presented included:

· A single dose of EDIT-401 achieved a 90% or greater mean reduction in

LDL-C, with rapid and dose-dependent effect, across a dose range and with durability through six months.

· A single dose of EDIT-401 achieved rapid, dose-dependent mean reduction

of approximately 90% in Lp(a), an independent risk factor for atherosclerotic cardiovascular disease (“ASCVD”).

· A single dose of EDIT-401 achieved rapid, dose-dependent mean reduction

of approximately 90% in ApoB, a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD.

· The reductions in LDL-C, Lp(a), and ApoB were highly correlated, supporting

a unified mechanism facilitated by upregulation of the LDL receptor.

The Company continues to advance preclinical studies for EDIT-401,

including an ongoing Good Laboratory Practice (“GLP”) toxicology study in NHPs. Interim results from this study were consistent

with the Company’s other preclinical studies, each of which demonstrated EDIT-401 was well-tolerated at the therapeutically relevant

dose of 1.5 mg/kg with no adverse clinical observations, no notable treatment-related liver enzyme elevations, and no liver histopathology

findings in non-GLP toxicology. EDIT-401 showed low functional liver editing rates with a mean of 12.4% at the therapeutically relevant

dose of 1.5 mg/kg. Low editing was detected in the adrenal gland, spleen and ovary, and no significant editing was observed in any other

of 31 total extrahepatic tissues compared to the vehicle control. Doses of 3 mg/kg and 6 mg/kg, which are greater than the therapeutically

relevant dose, were also evaluated. There were minimal to marked liver enzyme increases and non-adverse liver findings in NHPs administered

3 mg/kg and adverse clinical observations were observed in one NHP at the highest dose of 6 mg/kg.

The Company plans to submit a Clinical Trial Notification (“CTN”)

in Australia to the Therapeutic Goods Administration (TGA) in mid-2026, with the goal of initiating a first-in-human clinical trial of

EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) later in 2026 and expects to have early in vivo

human proof of concept data for EDIT-401 by the end of 2026. The Company anticipates that the clinical trial will initially be designed

as a two-part Phase 1/2 trial. Part 1 is expected to be a single ascending dose, dose-finding study and is expected to enroll approximately

18 patients with HeFH in three dosing arms. Eligible patients will have a clinical diagnosis of HeFH with an elevated LDL-C despite treatment

with two or more lipid lowering therapies. The Company plans to complete enrollment of Part 1 and have topline data results available

in 2027. The Company expects that Part 2 of the trial will be a single-dose randomized, placebo-controlled expansion study with approximately

28 patients, and that if the data from the Phase 1/2 trial warrant advancing EDIT-401, the Company would advance EDIT-401 into a single,

pivotal randomized, placebo-controlled Phase 3 clinical trial in patients with HeFH, with or without existing ASCVD or coronary artery

disease. These clinical trial plans are subject to further discussion and alignment with regulatory authorities.

The Company also received pre-IND feedback from the U.S. Food and Drug

Administration (“FDA”) on its nonclinical package, CMC plans, and study design to support an Investigational New Drug Application

(“IND”) for EDIT-401, which the Company believes provides optionality for submitting an IND supportive of the Company’s

anticipated clinical development strategy.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements

and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,”

“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”

“potential,” “predict,” “project,” “target,” “should,” “would,”

and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these

identifying words. Forward-looking statements in this Current Report on Form 8-K include statements regarding the initiation, timing,

progress and results of the Company’s preclinical studies and its research and development programs, including initiating a first-in-human

study for EDIT-401 in 2026 and achievement of early in vivo human proof-of-concept data for EDIT-401 by the end of 2026; the potential

of, and expectations for, EDIT-401; and the timing or likelihood of regulatory filings and approvals, including submitting a CTN in Australia

by mid-2026 for EDIT-401. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking

statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially

from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including:

uncertainties inherent in the initiation and completion of preclinical studies and clinical trials; availability and timing of results

from preclinical studies and clinical trials; uncertainties relating to planned regulatory submissions to initiate clinical trials, including

that results of preclinical studies will warrant such submissions or that regulatory agencies may require additional preclinical studies,

that regulatory submissions shall occur on the expected timelines and that regulatory authorities will provide clearance for trials to

be initiated; that the results and outcome of preclinical studies may not be predictive of the results of clinical trials; and the availability

of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These

and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent

Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent

filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission

in the future. Any forward-looking statements contained in this Current Report on Form 8-K represent the Company’s views only as

of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company

explicitly disclaims any obligation to update any forward-looking statements.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release issued by the Company on May 26, 2026*

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

*This exhibit shall be deemed to be furnished and not filed.

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: May 26, 2026

By:

/s/ Amy Parison

Amy Parison

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2615565d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Editas Medicine Presents EDIT-401 Preclinical

Data Demonstrating Robust Reductions in LDL-C, Lp(a), and ApoB in Non-Human Primates at the 94th European Atherosclerosis Society

Congress

Single dose of EDIT-401 achieved ~90% or

greater mean reductions in LDL-C, Lp(a), and ApoB in non-human primates

Data reinforce differentiated LDLR upregulation

approach with rapid, dose-dependent effects on multiple atherogenic lipoproteins

Company on track to submit CTN by mid-2026 for

EDIT-401 and achieve early in vivo human proof-of-concept data by the end of 2026

CAMBRIDGE, Mass., May 26, 2026 – Editas

Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company focused on developing transformative medicines for serious diseases,

presented new preclinical data for EDIT-401, its lead in vivo development candidate, in an oral presentation at the 94th

European Atherosclerosis Society (EAS) Congress in Athens, Greece on May 25, 2026. In the data presented, EDIT-401 achieved robust reductions

in LDL-cholesterol (LDL-C), lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB) in non-human primates (NHPs), supporting its potential

as a best-in-class medicine for hyperlipidemia.

Key EDIT-401 preclinical data in NHPs presented include:

· A single dose of EDIT-401 achieved ≥90% mean reduction in LDL-C,

with rapid and dose-dependent effect.

· EDIT-401 achieved rapid, dose dependent ~90% mean reduction in Lp(a),

an independent risk factor for atherosclerotic cardiovascular disease (ASCVD).

· EDIT-401 achieved rapid, dose-dependent ~90% mean reduction in ApoB,

a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD.

· Reductions in LDL-C, Lp(a), and ApoB were highly correlated, supporting

a unified mechanism facilitated by LDLR upregulation.

“The consistent reductions of ~≥90 percent with EDIT-401 in

LDL-C, Lp(a), and ApoB observed in these preclinical studies highlight the transformative potential of our LDLR upregulation approach

to address multiple drivers of cardiovascular risk, including residual risk beyond LDL-C alone,” said Linda C. Burkly, Ph.D.,

Executive Vice President and Chief Scientific Officer, Editas Medicine. “These robust and consistent reductions across multiple

atherogenic lipoproteins with a single dose further support EDIT-401 as a potentially best-in-class in vivo gene editing medicine

for people living with hyperlipidemia.”

The abstract can be accessed on the EAS website, and the presentation

is available on the Editas Medicine website.

Editas continues to advance preclinical studies for EDIT-401, including

an ongoing Good Laboratory Practice (GLP) toxicology study in NHPs. Interim results from this study demonstrated EDIT-401 was well-tolerated

with no adverse clinical observations, no notable treatment-related liver enzyme elevations, and no liver histopathology findings in non-GLP

toxicology at the therapeutically relevant dose of 1.5 mg/kg.

The Company also received positive pre-IND feedback from the U.S. Food

and Drug Administration (FDA) on its nonclinical package, CMC plans, and study design to support an Investigational New Drug Application

(IND). The Company plans to submit a Clinical Trial Notification (CTN) in Australia to the Therapeutic Goods Administration (TGA) by mid-2026

to initiate a first-in-human clinical trial of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (HeFH) later this

year, and is on track to have early in vivo human proof-of-concept data for EDIT-401 by the end of 2026.

About Editas Medicine

As a pioneering gene editing company, Editas Medicine is focused on

translating the power and potential of CRISPR genome editing systems into a robust pipeline of transformative in vivo medicines

for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize durable,

precision in vivo gene editing medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of

Broad Institute’s Cas12a patent estate and Broad Institute and Harvard University’s Cas9 patent estates for human medicines.

For the latest information and scientific presentations, please visit www.editasmedicine.com.

Forward-Looking Statements

This press release contains forward-looking statements and information

within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’

‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’

‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’

‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’

‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking

statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation,

timing, progress and results of the Company’s preclinical studies and its research and development programs, including initiating

a first-in-human study for EDIT-401 in 2026 and achievement of early in vivo human proof-of-concept data for EDIT-401 by the end

of 2026; the potential of, and expectations for, EDIT-401; and the timing or likelihood of regulatory filings and approvals, including

submitting a CTN in Australia by mid-2026 for EDIT-401. The Company may not actually achieve the plans, intentions, or expectations disclosed

in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events

could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various

important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials; availability

and timing of results from preclinical studies and clinical trials; uncertainties relating to planned regulatory submissions to initiate

clinical trials, including that results of preclinical studies will warrant such submissions or that regulatory agencies may require additional

preclinical studies, that regulatory submissions shall occur on the expected timelines and that regulatory authorities will provide clearance

for trials to be initiated; that the results and outcome of preclinical studies may not be predictive of the results of clinical trials;

and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure

requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s

most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s

subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and

Exchange Commission in the future. Any forward-looking statements contained in this press release represent the Company’s views

only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law,

the Company explicitly disclaims any obligation to update any forward-looking statements.

###

Investor and Media Contacts:

ir@editasmed.com

media@editasmed.com

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