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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): January 8, 2026
ENTRADA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-40969 81-3983399
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
One Design Center Place
Suite 17-500
Boston, MA
02210
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (857) 520-9158

Not Applicable
(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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 TRDA The Nasdaq Global Market
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 x
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. o On January 8, 2026, Entrada Therapeutics, Inc, (the “Company”) announced that it estimates it had approximately $296 million of cash, cash equivalents and marketable securities as of December 31, 2025.
 



Item 2.02 Results of Operations and Financial Condition.


The information contained in this Item 2.02 is unaudited and preliminary, and does not present all information necessary for an understanding of the Company’s results of operations for the fiscal year ended December 31, 2025, or financial condition as of December 31, 2025. The audit of the Company’s consolidated financial statements for the year ended December 31, 2025 is ongoing and could result in changes to the information in this Item 2.02.

The information in Item 2.02 of this Current Report on Form 8-K 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 a filing.

Item 7.01 Regulation FD Disclosure.

On January 8, 2026, the Company issued a press release titled “Entrada Therapeutics Highlights Progress Across its Portfolio of RNA-based Therapeutics for the Treatment of Neuromuscular and Ocular Diseases.” The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On January 14, 2026, the Company will be presenting at the 44th Annual J.P. Morgan Healthcare Conference, where it will also meet with investors, analysts and others.

The information in this Item 7.01 of this Current Report on Form 8-K, including the accompanying 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 liability of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On January 8, 2026, the Company reported its progress across its portfolio of RNA-based therapeutics for the treatment of neuromuscular and ocular diseases. The Company completed dosing of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping, and transitioned to the open label, Phase 2 portion of the study. The Company is on track to report ELEVATE-44-201 data from the first cohort in Q2 2026 and ELEVATE-45-201 data from the first cohort in mid-2026. In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44. The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory patients living with DMD who are amenable to exon 50 skipping. The Company expects to initiate global Phase 1/2 MAD clinical study of ENTR-601-50 by the end of 2026 and to submit global regulatory applications for ENTR-601-51 in 2026. The Company also announced that it is expanding its pipeline with the selection of ENTR-801 as first clinical candidate in ocular diseases for the treatment of Usher syndrome type 2A, and it expects to nominate a second ocular clinical candidate in 2026.

Forward Looking Statements

This Current Report on Form 8-K includes express and implied “forward-looking statements.” Forward looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in this Current Report on Form 8-K include, but are not limited to, statements regarding the Company’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of its approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding its Phase 1/2 multiple ascending dose (“MAD”) clinical study of ENTR-601-44, including the timing of data from Cohort 1 in the second quarter of 2026, Cohort 2 by end of 2026 and Cohort 3 to follow, expectations regarding initiation of the planned ELEVATE-44-102 study in the U.S.



in the first half of 2026, expectations regarding the Company’s Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in mid-2026, with data from Cohort 2 and Cohort 3 to follow, expectations regarding the timing of regulatory filings in the European Union for the planned Phase 1/2 MAD clinical study of ENTR-601-50 in the second half of 2026 and initiation by the end of 2026, pending clearance, expectations regarding the timing of global regulatory filings and clearance for the planned clinical study of ENTR-601-51 in 2026, the ability to recruit for and complete global Phase 2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of the Company’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of nomination of a second clinical candidate for ocular disease in 2026, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the potential treatment of Duchenne muscular dystrophy and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of myotonic dystrophy type 1, expectations regarding the progress and success of the Company’s collaboration with Vertex Pharmaceuticals Incorporated, including completion of enrollment and dosing of the MAD portion of the global Phase 1/2 study of the VX-670 program in the first half of 2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the Company’s preliminary and unaudited estimate of cash resources as of December 31, 2025 and the sufficiency of its cash resources into the third quarter of 2027. By their nature, these statements are subject to numerous risks and uncertainties, including factors beyond the Company’s control, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. For further information regarding the risks, uncertainties and other factors that may cause differences between the Company’s expectations and actual results, you should review the “Risk Factors” in Item 1A of Part II of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings. You should not rely upon forward-looking statements as predictions of future events. Although the Company’s management believes that the expectations reflected in the Company’s statements are reasonable, the Company cannot guarantee that the future results, performance or events and circumstances described in the forward-looking statements will be achieved or occur. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact.
Item 9.01    Financial Statements and Exhibits.
(d)Exhibits.

The following exhibit relating to Item 7.01 of this Form 8-K shall be deemed to be furnished and not filed:
99.1
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: January 8, 2026 /s/ Dipal Doshi
Dipal Doshi
Chief Executive Officer

EX-99.1 2 entradatherapeuticshighlig.htm EX-99.1 Document
image_0a.jpg

Entrada Therapeutics Highlights Progress Across its Portfolio of RNA-based Therapeutics for the Treatment of Neuromuscular and Ocular Diseases

-- Company on track to report ELEVATE-44-201 data from the first cohort in Q2 2026 and ELEVATE-45-201 data from the first cohort in mid-2026 –

-- Expects to initiate global Phase 1/2 MAD clinical study of ENTR-601-50 by the end of 2026 and to submit global regulatory applications for ENTR-601-51 in 2026 –

-- Expands pipeline with selection of ENTR-801 as first clinical candidate in ocular diseases for the treatment of Usher syndrome type 2A and expects to nominate second clinical candidate in 2026 –

-- Cash runway into Q3 2027 –

-- Entrada to present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 PM PT (6:45 PM ET) --

BOSTON, Jan. 8, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported progress across its robust development portfolio of RNA-based programs for the potential treatment of neuromuscular and ocular diseases.

“In 2025, we strategically positioned Entrada to significantly advance what we believe to be best-in-class therapies for people living with Duchenne muscular dystrophy, and expanded our pipeline into ocular diseases with the selection of our first clinical candidate targeting Usher syndrome, an inherited retinal disorder with a profound unmet clinical need,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “2026 will be a data-rich year for our Duchenne franchise, with multiple readouts including data from the first cohort of ELEVATE-44-201 expected in the second quarter of 2026 and ELEVATE-45-201 in mid-2026. We also plan to advance our growing development portfolio of RNA-based programs and expect to nominate a second clinical candidate in ocular diseases later this year. With sufficient cash resources available, we believe we are well-positioned to advance and expand our unique pipeline of intracellular therapeutics.”

Entrada highlights the following progress against its goal of building a diverse pipeline of transformative therapeutics that address areas of high unmet need where the Company can have a profound impact for patients and their families:

Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. In 2026, the Company expects to have four clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51), complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex.




•ELEVATE-44-201: The Company completed dosing of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping, and transitioned to the open label, Phase 2 portion of the study. The Company is on track to report data from Cohort 1 (6 mg/kg) in the second quarter of 2026, data from Cohort 2 (up to 12 mg/kg) by year-end, and data from Cohort 3 (up to 18 mg/kg) to follow. In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44.
•ELEVATE-44-102: The Company expects to initiate a Phase 1b MAD clinical study of ENTR-601-44 in ambulatory and non-ambulatory adults living with DMD in the U.S. in the first half of 2026.
•ELEVATE-45-201: The Company initiated patient dosing in the global Phase 1/2 MAD portion of the clinical study of ENTR-601-45 in ambulatory patients living with DMD who are amenable to exon 45 skipping. The Company is on track to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 10 mg/kg and 15 mg/kg) to follow.
•ELEVATE-50-201: The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory patients living with DMD who are amenable to exon 50 skipping. The Company expects to submit regulatory applications in the EU for ENTR-601-50 in the second half of 2026 and initiate the study by the end of 2026.
•ENTR-601-51: The Company expects to submit global regulatory applications for ENTR-601-51 in 2026.
•VX-670: Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 in people living with DM1, which will assess both safety and efficacy. Vertex is on track to complete enrollment and dosing in the trial in the first half of 2026.

Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases, which include new modalities.
The Company has advanced two ocular programs into lead optimization for the potential treatment of inherited retinal diseases. Both programs are novel oligonucleotide-based therapeutics with the potential to address areas of high unmet need. In December 2025, Entrada declared its first ocular clinical candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A). The Company plans to announce a second clinical candidate in ocular diseases in 2026.
•ENTR-801: The Company’s first ocular candidate is an optimized, proprietary oligonucleotide-based therapy for the potential treatment of a subgroup of patients with Usher syndrome type 2A (USH2A), who are amenable to exon 13 skipping. The clinical candidate is being designed to restore functional usherin protein production with the goal of preserving photoreceptors (the light-sensing cells in the eye) to stabilize the overall retinal architecture and preserve function.



ENTR-801 was selected from a library of 200 sequences based on its robust exon skipping and usherin protein production, as well as initial safety in multiple animal models.
USH2A is an inherited eye disease caused by changes in the USH2A gene. In some people, mutations in exon 13 prevent the body from producing usherin, a protein that is essential for the health of photoreceptors. Without usherin, photoreceptors gradually degenerate, leading to progressive vision loss that often begins in early adulthood and can progress to legal blindness by mid-adulthood. There are currently no approved therapies that address the underlying cause of Usher syndrome. In the United States and Europe, approximately 15,000 people are living with Usher syndrome type 2A who may be amenable to exon 13 skipping.
Cash Runway: The Company continues to be well-capitalized with cash runway anticipated into Q3 2027.

J.P. Morgan Healthcare Conference Presentation and Webcast
Dipal Doshi will deliver a company presentation at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 PM PT (6:45 PM ET). A live webcast will be available on the Presentations portion of Entrada’s Investor Relations website at https://ir.entradatx.com. The webcast will be archived and available for replay for 30 days after the event.

About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular, ocular and other diseases, leveraging next-generation EEVs, novel oligonucleotide sequences and an advanced protein engineering platform. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.

Forward-Looking Statements
This press release contains express and implied forward-looking statements that involve substantial risks and uncertainties.



All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the timing of data from Cohort 1 in the second quarter of 2026, Cohort 2 by end of 2026 and Cohort 3 to follow, expectations regarding initiation of the planned ELEVATE-44-102 study in the U.S. in the first half of 2026, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in mid-2026, with data from Cohort 2 and Cohort 3 to follow, expectations regarding the timing of regulatory filings in the EU for the planned Phase 1/2 MAD clinical study of ENTR-601-50 in the second half of 2026 and initiation by the end of 2026, pending clearance, expectations regarding the timing of global regulatory filings and clearance for the planned clinical study of ENTR-601-51 in 2026, the ability to recruit for and complete global Phase 2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of nomination of a second clinical candidate for ocular disease in 2026, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the potential treatment of DMD and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, including completion of enrollment and dosing of the MAD portion of the global Phase 1/2 study of the VX-670 program in the first half of 2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the sufficiency of its cash resources into the third quarter of 2027, 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 terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada 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 identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change.



However, while Entrada may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Entrada’s views as of any date subsequent to the date of this press release.

Investor Contact
Karla MacDonald
Chief Corporate Affairs Officer
kmacdonald@entradatx.com

Patient Advocacy Contact
Sarah Friedhoff
Head of Patient Advocacy
patientadvocacy@entradatx.com

Media Contact
Megan Prock McGrath
CTD Comms, LLC
megan@ctdcomms.com