# EDGAR Filing Document

**Accession Number:** 0001650664
**File Stem:** 0001650664-25-000134
**Filing Date:** 2025-9
**Character Count:** 21049
**Document Hash:** 1d5a1b55f30f2538f404534472bcd10c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001650664-25-000134.hdr.sgml**: 20250902

**ACCESSION NUMBER**: 0001650664-25-000134

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20250902

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250902

**DATE AS OF CHANGE**: 20250902

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Editas Medicine, Inc.
- **CENTRAL INDEX KEY:** 0001650664
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 464097528
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37687
- **FILM NUMBER:** 251282921

**BUSINESS ADDRESS:**
- **STREET 1:** 11 HURLEY ST.
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02141
- **BUSINESS PHONE:** 617-401-9000

**MAIL ADDRESS:**
- **STREET 1:** 11 HURLEY ST.
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02141

?xml version='1.0' encoding='ASCII'? edit-20250902

**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): September 2, 2025

_________________________________________________________________________________________

**Editas Medicine, Inc.**

(Exact Name of Registrant as Specified in its Charter)

_________________________________________________________________________________________

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| | | |
|:---|:---|:---|
| **Delaware** | **001-37687** | **46-4097528** |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |

---

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| | | |
|:---|:---|:---|
| **11 Hurley Street** | **11 Hurley Street** | |
| **Cambridge,** | **Massachusetts** | **02141** |
| (Address of Principal Executive Offices) | (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:

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| | | |
|:---|:---|:---|
| **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 |

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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 □

If 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. □

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**Item 7.01&nbsp;&nbsp;&nbsp;&nbsp;Regulation FD Disclosure.**

On September 2, 2025, Editas Medicine, Inc. (the "Company") issued a press release titled "Editas Medicine Nominates EDIT-401, an LDLR-Targeted Medicine, as Lead *In Vivo* Development Candidate," 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.**

*Nomination of Lead Development Candidate*

On September 2, 2025, the Company announced the nomination of its lead *in vivo* development candidate, EDIT-401, a therapy designed to reduce LDL cholesterol ("LDL-C") levels. EDIT-401 is an experimental *in vivo* gene editing medicine, based on Editas' differentiated upregulation approach. EDIT-401 is designed to treat hyperlipidemia by directly editing the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. This targeted approach has demonstrated a favorable preclinical profile in both efficacy data and tolerability and supports the potential of EDIT-401 to deliver meaningful clinical outcomes for patients underserved by current lipid-lowering therapies. EDIT-401 is designed to be a one-time treatment that can provide lifelong benefit.

In preclinical studies in non-human primates, EDIT-401 achieved approximately 90 percent mean reduction of LDL-C levels. This level of reduction was observed following a single dose of EDIT-401 (at all four dose levels of EDIT-401 evaluated, from 1.5 mg/kg to 4 mg/kg), as early as 48 hours after dosing and was sustained for the one-month study duration.

In addition, in these preclinical studies, EDIT-401 increased the liver's production of the LDLR protein, a protein that removes LDL-C from the blood stream. Specifically, in these studies, the Company observed an at least six-fold mean increase in LDLR protein levels following treatment with EDIT-401.

Additionally, there were no adverse effects observed. There were transient increases in liver enzymes that resolved within one week.

*Hematopoietic Stem Cells Program Update and Pipeline*

The Company intends to continue work on optimizing candidates for its Hematopoietic Stem Cell program and to continue exploring other cell types and tissues for development, but plans to focus its resources on the advancement of its lead EDIT-401 program to human proof-of-concept.

*Key Upcoming Planned Milestones* 

The Company expects to identify and disclose an additional target cell type or tissue by the end of 2025. By mid-2026, it plans to submit an investigational new drug ("IND") or clinical trial application ("CTA") for EDIT-401, with the goal of achieving *in vivo* human proof-of-concept data for EDIT-401 by the end of 2026.

*Cash Runway*

The Company re-confirmed its cash runway guidance that it expects that its existing cash, cash equivalents, and marketable securities as of June 30, 2025 and the retained portions of the payments payable under its license agreement with Vertex Pharmaceuticals will enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2027.

*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,''

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''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 the Company's expectation to achieve human proof-of-concept data for EDIT-401 by end of 2026 and identify and disclose an additional target cell type or tissue by the end of 2025; the potential of, and expectations for, EDIT-401; the timing or likelihood of regulatory filings and approvals, including submission of an IND or CTA for EDIT-401 by mid-2026; and the Company's expectations regarding its cash runway. 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; expectations for regulatory approvals to conduct trials; that the outcome of preclinical testing may not be indicative of the results of clinical trials and early clinical trials may not be predictive of the outcomes of later clinical trials; that preclinical data of one compound may not be comparable with clinical data for another compound; that the market opportunity for EDIT-401 may not be as significant as the Company expects; and uncertainties with respect to the availability of resources and financing sufficient to fund 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&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Exhibits

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| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | <u>[Press release issued by the Company on September 2, 2025\*](final_edit-401pressrelease.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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

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**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. | EDITAS MEDICINE, INC. |
| Date: September 2, 2025 | By: | /s/ Amy Parison |
|  |  | Amy Parison |
|  |  | Chief Financial Officer |

---

## Ex-99

**Exhibit 99.1**

![imagea.jpg](imagea.jpg)

**Editas Medicine Nominates EDIT-401, an LDLR-Targeted Medicine, as Lead *In Vivo* Development Candidate**

*EDIT-401 achieved ~90% mean LDL-C reduction with single dose in non-human primates*

*EDIT-401 on track for human proof-of-concept data by end of 2026*

*Strong cash position with operational runway into second quarter of 2027*

*Company-sponsored webinar on EDIT-401 today at 8:00 a.m. ET*

CAMBRIDGE, Mass., Sept. 2, 2025 – Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company, today announced the nomination of its lead *in vivo* development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol (LDL-C) levels.

"Today's nomination of EDIT-401 as our lead *in vivo* development candidate is a significant milestone in our long-term vision to lead the field of *in vivo* programmable gene editing," said Gilmore O'Neill, M.B., M.M.Sc., President and Chief Executive Officer of Editas Medicine. "At Editas Medicine, we believe *in vivo* is the future of medicine. With EDIT-401, we're advancing our differentiated upregulation strategy to develop a next-generation medicine that can deliver lasting impact for patients."

**About EDIT-401**

EDIT-401 is an experimental, potentially transformative *in vivo* gene editing medicine, based on Editas' differentiated upregulation approach. EDIT-401 is designed to treat hyperlipidemia by directly editing the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. This targeted approach has demonstrated a favorable preclinical profile in both efficacy data and tolerability and supports the potential of EDIT-401 to deliver meaningful clinical outcomes for patients underserved by current lipid-lowering therapies.

Key highlights of EDIT-401 include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Robust efficacy data with ~90 percent mean reduction of LDL-C in preclinical non-human primate studies, while standard of care therapies demonstrate a 40-60% mean reduction of LDL-C

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Potential one-time treatment designed for lifelong benefit

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sizeable market potential with favorable health care system economics

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Attractive business model expected to align with typical biopharma margins

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Compelling preclinical data supporting rapid progression to human proof-of-concept data by end of 2026

**About Hyperlipidemia and Atherosclerotic Cardiovascular Disease (ASCVD)**

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death worldwide and imposes a significant burden on the US healthcare system with national expenditures projected to reach over $300 billion in 2035. Elevated LDL-C is a major causal factor in ASCVD disease. Elevated LDL-C, also known as hyperlipidemia, is a highly prevalent disease affecting over 70 million patients in the United States alone. Substantial unmet need exists across multiple at-risk segments of patients with hyperlipidemia.

"EDIT-401 leverages our *in vivo* gene editing platform to precisely target noncoding regions that regulate LDLR gene expression," said Linda C. Burkly, Ph.D., Executive Vice President and Chief Scientific Officer of Editas Medicine. "This targeted editing approach enables direct upregulation of LDLR, with the potential for EDIT-401 to deliver meaningful benefits beyond the current standard of care across multiple segments of the hyperlipidemia population."<br>

**Hematopoietic Stem Cells Program Update**

Editas remains committed to progressing its other programs and pipeline. The Company intends to continue work on optimizing candidates for its Hematopoietic Stem Cell (HSC) program but plans to focus its resources on the advancement of its lead EDIT-401 program to human proof-of-concept. <br>**Key Upcoming Planned Milestones** 

The Company expects to identify and disclose an additional target cell type or tissue by the end of 2025. By mid-2026, it plans to submit an investigational new drug (IND) or clinical trial application (CTA) for EDIT-401, with the goal of achieving in vivo human proof-of-concept data for EDIT-401 by the end of 2026.

**Cash Runway**

As of June 30, 2025, the Company had cash, cash equivalents, and marketable securities of $178.5 million. Editas re-confirmed its cash runway guidance and expects that its existing cash, cash equivalents, and marketable securities and the retained portions of the payments payable under its license agreement with Vertex Pharmaceuticals will enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2027.

<br> <br> <br>

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**Webinar Presentation Details:**

The Company will host a webinar on Tuesday, September 2, 2025 at 8:00 a.m. ET to discuss the selection of EDIT-401 as its lead *in vivo* development candidate. The live and archived webcast of the Company's webinar presentation will be accessible through this webcast link, or through the Events & Presentations page of the "Investors" section of the Company's website.

A replay of the webinar will be available upon conclusion of the webinar in the Investors section of the Editas Medicine website at www.editasmedicine.com.

**About Editas Medicine**<br>As a pioneering gene editing company, Editas Medicine is focused on translating the power and potential of the 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, including statements regarding the potential market for EDIT-401, if approved. 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 the Company's expectation to achieve human proof-of-concept data for EDIT-401 by end of 2026 and identify and disclose an additional target cell type or tissue by the end of 2025; the potential of, and expectations for, EDIT-401; the timing or likelihood of regulatory filings and approvals, including submission of an IND or CTA for EDIT-401 by mid-2026; and the Company's expectations regarding its cash runway. 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; expectations for regulatory approvals to conduct trials; that the outcome of preclinical testing may not be indicative of the results of clinical trials and early clinical trials may not be predictive

<br> <br> <br>

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of the outcomes of later clinical trials; that preclinical data of one compound may not be comparable with clinical data for another compound; that the market opportunity for EDIT-401 may not be as significant as the Company expects; and uncertainties with respect to the availability of resources and financing sufficient to fund 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.<br>**Media and Investor Contacts:**

media@editasmed.com

ir@editasmed.com

<br> <br> <br>

<br>