TRDA 8-K
Entrada Therapeutics, Inc. (TRDA)
8-K
2026-02-26
For: 2026-02-26
View Original
Added on
April 10, 2026
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): February 26, 2026
(Exact name of registrant as specified in its charter)
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Registrant’s telephone number, including area code: (857) 520-9158
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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:
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Securities registered pursuant to Section 12(b) of the Act:
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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 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
Item 2.02 Results of Operations and Financial Condition.
On February 26, 2026, Entrada Therapeutics, Inc. announced its financial results for the quarter ended December 31, 2025 and other corporate updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (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 9.01 Financial Statements and Exhibits.
(d)Exhibits.
The following exhibit relating to Item 2.02 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: February 26, 2026 | /s/ Dipal Doshi | |||||||
| Dipal Doshi | ||||||||
| Chief Executive Officer | ||||||||
Entrada Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
-- Company on track to report ELEVATE-44-201 data from Cohort 1 in Q2 2026 and Cohort 2 by year-end 2026 --
-- Company on track to report ELEVATE-45-201 data from Cohort 1 in mid-2026
-- Independent Data Monitoring Committee recommended initiation of Cohort 2 at the increased dose of 12 mg/kg in the ELEVATE-44-201 study --
-- Cash runway expected into Q3 2027 with $296 million in cash, cash equivalents and marketable securities as of December 31, 2025 --
BOSTON, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted recent business updates.
“We have started 2026 with strong momentum, including a positive DMC recommendation to initiate the second cohort of ELEVATE-44-201 at the increased dose of 12 mg/kg. In the coming months, we will share multiple clinical readouts, including data from the first patient cohorts of the ELEVATE-44-201 and ELEVATE-45-201 studies, as well as the second patient cohort of the ELEVATE-44-201 study later in the year. We strongly believe these results continue to derisk our entire neuromuscular portfolio," said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We are also advancing our growing development portfolio of genetic medicines, with the nomination of ENTR-801 for the potential treatment of Usher syndrome type 2A and the planned nomination of a second clinical candidate in inherited retinal diseases expected later this year. With a cash runway into the third quarter of 2027, we believe we are well-positioned to continue expanding our unique pipeline of intracellular therapeutics.”
Recent Corporate Highlights
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: 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. An independent Data Monitoring Committee (DMC) has reviewed the data to date from the eight patients enrolled in Cohort 1 and recommended the initiation of Cohort 2 at the increased dose of 12 mg/kg without any protocol modification. All participants from Cohort 1 have transitioned into 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 (12 mg/kg) by year-end 2026, and data from Cohort 3 (up to 18 mg/kg) to follow. Entrada intends to open an expansion cohort later in the year to increase the number of participants treated in the ELEVATE-44-201 study, as this study has been designed to support
an accelerated approval in the U.S. 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 believes this clinical study, in the underserved adult patient population with advanced disease, would be best to initiate at the highest advisable starting dose. Following a review of safety, pharmacokinetic and pharmacodynamic data from the ELEVATE-44-201 study in the U.K. and EU in Q2 2026, the Company plans to re-engage with the FDA to discuss increasing the planned doses in this clinical study. As such, the Company will provide an update on clinical study design and timing following interactions with the FDA.
•ELEVATE-45-201: Initiated patient dosing in the global Phase 1/2 MAD 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, respectively) 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 and obtain authorization in the EU for ENTR-601-50 by year-end 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 GALILEO global Phase 1/2 clinical study of VX-670 in people with DM1. The study assesses both safety and efficacy and is on track to complete enrollment and dosing in mid-2026.
Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases. The pipeline includes the advancement of two novel oligonucleotide-based programs for the potential treatment of inherited retinal diseases, where there exists high unmet need. The first ocular candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A) was announced in December 2025. The Company plans to announce a second clinical candidate in ocular disease in the second half of 2026.
Upcoming Investor Conference
•TD Cowen’s 46th Annual Health Care Conference, Boston, MA on March 3, 2026
Fourth Quarter and Full Year 2025 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $295.7 million as of December 31, 2025, compared to $420.0 million as of December 31, 2024. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of December 31, 2025 will be sufficient to fund its operations into the third quarter of 2027.
Collaboration Revenue: Collaboration revenue was $1.3 million for the fourth quarter of 2025 and $25.4 million for the full year of 2025, compared to $37.4 million and $210.8 million for the same periods in 2024. This decrease is primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-670 during the first quarter of 2025.
Research & Development (R&D) Expenses: R&D expenses were $34.0 million for the fourth quarter and $142.3 million for the full year of 2025, compared to $33.4 million and $125.3 million for the same periods in 2024. The increase was primarily driven by additional costs incurred related to the Company’s DMD programs, as well as higher personnel costs (including non-cash, stock-based compensation).
General & Administrative (G&A) Expenses: G&A expenses were $9.6 million for the fourth quarter and $41.1 million for the full year of 2025, compared to $9.9 million and $38.5 million for the same periods in 2024. The annual increase was primarily due to higher personnel costs (including non-cash, stock-based compensation).
Net Income (loss): Net loss was $(39.2) million for the fourth quarter of 2025 and $(143.8) million for the full year of 2025, compared to a net income of $1.1 million and $65.6 million for the same periods in 2024.
About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy 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.
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy 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, data from Cohort 2 by end of 2026 and data from Cohort 3 to follow, expectations regarding the initiation of the planned ELEVATE-44-102 study in the U.S., including plans to re-engage with the FDA to discuss increasing planned doses, 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 by year-end 2026, 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 the second half of 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 mid-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.
ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
Collaboration revenue | $ | 1,299 | $ | 37,398 | $ | 25,421 | $ | 210,782 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 33,957 | 33,406 | 142,269 | 125,306 | |||||||||||||||||||
| General and administrative | 9,550 | 9,859 | 41,050 | 38,465 | |||||||||||||||||||
| Total operating expenses | 43,507 | 43,265 | 183,319 | 163,771 | |||||||||||||||||||
(Loss) income from operations | (42,208) | (5,867) | (157,898) | 47,011 | |||||||||||||||||||
Other income: | |||||||||||||||||||||||
Interest and other income | 3,136 | 5,128 | 15,072 | 19,474 | |||||||||||||||||||
Total other income | 3,136 | 5,128 | 15,072 | 19,474 | |||||||||||||||||||
(Loss) income before provision for income taxes | (39,072) | (739) | (142,826) | 66,485 | |||||||||||||||||||
| Provision for (benefit from) income taxes | 92 | (1,870) | 924 | 859 | |||||||||||||||||||
Net (loss) income | $ | (39,164) | $ | 1,131 | $ | (143,750) | $ | 65,626 | |||||||||||||||
Net (loss) income per share, basic | $ | (0.94) | $ | 0.03 | $ | (3.47) | $ | 1.76 | |||||||||||||||
Net (loss) income per share, diluted | $ | (0.94) | $ | 0.03 | $ | (3.47) | $ | 1.68 | |||||||||||||||
Weighted‑average common shares outstanding, basic | 41,604,063 | 40,842,849 | 41,371,486 | 37,306,363 | |||||||||||||||||||
Weighted‑average common shares outstanding, diluted | 41,604,063 | 43,050,483 | 41,371,486 | 39,003,169 | |||||||||||||||||||
ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data (Unaudited)
(In thousands)
December 31, | December 31, | ||||||||||
| 2025 | 2024 | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 295,698 | $ | 419,998 | |||||||
| Total assets | $ | 377,378 | $ | 526,321 | |||||||
| Total liabilities | $ | 71,245 | $ | 97,643 | |||||||
| Total stockholders’ equity | $ | 306,133 | $ | 428,678 | |||||||
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