TRDA 8-K
Entrada Therapeutics, Inc. (TRDA)
8-K
2025-05-08
For: 2025-05-08
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): May 8, 2025
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (857) 520-9158
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(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:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
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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 May 8, 2025, Entrada Therapeutics, Inc. announced its financial results for the quarter ended March 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: May 8, 2025 | /s/ Dipal Doshi | |||||||
| Dipal Doshi | ||||||||
| Chief Executive Officer | ||||||||
Entrada Therapeutics Reports First Quarter 2025 Financial Results
– Receives regulatory authorization in the EU for ELEVATE-44-201, a Phase 1/2 MAD clinical study of ENTR-601-44 in patients living with Duchenne muscular dystrophy who are amenable to exon 44 skipping –
– Company remains on track to initiate ELEVATE-44-201 and ELEVATE-45-201 in Q2 and Q3 2025, respectively –
– Cash runway expected into Q2 2027 with $383 million in cash, cash equivalents and marketable securities as of March 31, 2025 –
BOSTON, May 8, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2025, and highlighted recent business updates.
“We are excited to announce the first European Union regulatory clearance within our Duchenne franchise, with the authorization to initiate the ELEVATE-44-201 patient study across multiple countries. The first quarter of 2025 has been highly productive, with clearances granted for the first two of our novel exon skipping Duchenne programs, ENTR-601-44 and ENTR-601-45," said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We expect to quickly advance three distinct Duchenne programs — for people who are exon 44, 45 and 50 skip amenable — into global clinical development by the end of this year. In parallel, our partnered program with Vertex for myotonic dystrophy type 1, VX-670, continues to progress in the clinic. This increased clinical momentum, combined with a cash runway expected into Q2 2027 and our ongoing commitment to financial discipline, positions us strongly despite the challenging macroeconomic environment.”
Recent Corporate Highlights
•In May 2025, the ELEVATE-44-201 study received authorization from the Health Authorities and Ethics Committees of multiple countries under the European Union Clinical Trial Regulation (EU-CTR).
•The recent EU authorization of ELEVATE-44-201 builds upon the Company’s significant clinical momentum. Since January 2025, Entrada has received authorization to initiate clinical studies in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These authorizations include:
oELEVATE-44-201: A global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable
to exon 44 skipping. The study will run in the U.K. and EU and is on track to initiate in the second quarter of 2025.
oELEVATE-44-102: A Phase 1b MAD clinical study of ENTR-601-44 in ambulatory and non-ambulatory adults living with DMD. The study will run in the U.S. and is on track to initiate in the first half of 2026.
oELEVATE-45-201: A 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 study has been authorized to start in the U.K., and the Company has submitted for regulatory authorization in the EU. The study is on track to initiate in the third quarter of 2025.
•The Company remains on track to submit global regulatory applications for ENTR-601-50 in the second half of 2025 and for ENTR-601-51 in 2026.
•Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 in people with myotonic dystrophy type 1 (DM1), which will assess both safety and efficacy.
•In April 2025, Entrada initiated a strategic plan to focus the Company’s resources on its expanding portfolio of DMD clinical candidates (ENTR-601-44, -45, -50 and -51), key preclinical programs, including ocular, and maturing platform investments. Activities include enhanced hiring efforts to support planned global clinical study execution in DMD, as well as focused reductions in select research areas, which reduced the Company’s workforce by approximately 20%.
Upcoming Investor Conferences
•H.C. Wainwright 3rd Annual BioConnect Investor Conference in New York, NY on May 20, 2025.
•Jefferies Global Healthcare Conference in New York, NY on June 4, 2025.
•Goldman Sachs 46th Annual Global Healthcare Conference 2025 in Miami Beach, FL on June 9, 2025.
First Quarter 2025 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $382.5 million as of March 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 March 31, 2025 will be sufficient to fund its operations into the second quarter of 2027.
Collaboration Revenue: Collaboration revenue was $20.6 million for the first quarter of 2025, compared to $59.1 million for the same period in 2024.
Research & Development (R&D) Expenses: R&D expenses were $32.1 million for the first quarter of 2025, compared to $28.6 million for the same period in 2024. The increase was primarily driven by additional costs incurred related to our Duchenne programs, as well as higher personnel costs (including non-cash, stock-based compensation).
General & Administrative (G&A) Expenses: G&A expenses were $10.3 million for the first quarter of 2025, compared to $9.4 million for the same period in 2024. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation).
Net Income (loss): Net loss was $(17.3) million for the first quarter of 2025, compared to net income of $23.5 million for the same period 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 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. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. 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 planned 1/2 MAD clinical study of ENTR-601-44 in the U.K. and EU, including its initiation in the U.K. and EU in the second quarter of 2025, expectations regarding Entrada’s planned 1/2 MAD clinical study of ENTR-601-45 in the U.K. and EU, including its initiation in the U.K. in the third quarter of 2025, the ability to recruit for and complete the ELEVATE-44-102 study in the U.S., including its initiation in the U.S. in the first half of 2026, the ability to recruit for and complete global Phase 2 clinical studies for ENTR-601-44,
ENTR-601-45, ENTR-601-50 and ENTR-601-51, expectations regarding the timing of global regulatory filings for the planned Phase 2 clinical studies for ENTR-601-50 in the second half of 2025 and for ENTR-601-51 in 2026, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including the potential for ENTR-601-44 to be a transformative treatment option, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and the partnered product candidate VX-670 for the treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, the ability to continue to expand and develop additional therapeutic programs, including further exon skipping programs, and the sufficiency of its cash resources into the second half 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; the risk that the costs and charges associated with the Company’s new strategic plan may be greater than anticipated or incurred in different periods than anticipated; the risk that the Company’s efforts in connection with the new strategic plan may adversely affect the Company’s internal programs and the Company’s ability to recruit and retain skilled and motivated personnel, and may be distracting to employees and management; the risk that the Company’s efforts in connection with the new strategic plan may negatively impact the Company’s business operations and reputation; the risk that the Company’s efforts in connection with the new strategic plan may not generate their intended benefits to the extent or as quickly as anticipated; 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 March 31, | |||||||||||
2025 | 2024 | ||||||||||
| Collaboration revenue | $ | 20,558 | $ | 59,120 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 32,074 | 28,608 | |||||||||
| General and administrative | 10,274 | 9,399 | |||||||||
| Total operating expenses | 42,348 | 38,007 | |||||||||
| (Loss) income from operations | (21,790) | 21,113 | |||||||||
| Other income: | |||||||||||
| Interest and other income | 4,441 | 4,214 | |||||||||
| Total other income | 4,441 | 4,214 | |||||||||
| (Loss) income before provision for income taxes | (17,349) | 25,327 | |||||||||
| Provision for income taxes | — | 1,831 | |||||||||
| Net (loss) income | $ | (17,349) | $ | 23,496 | |||||||
| Net (loss) income per share, basic | $ | (0.42) | $ | 0.70 | |||||||
| Net (loss) income per share, diluted | $ | (0.42) | $ | 0.68 | |||||||
| Weighted‑average common shares outstanding, basic | 41,073,732 | 33,497,072 | |||||||||
| Weighted‑average common shares outstanding, diluted | 41,073,732 | 34,790,925 | |||||||||
ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data (Unaudited)
(In thousands)
March 31, | December 31, | ||||||||||
| 2025 | 2024 | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 382,515 | $ | 419,998 | |||||||
| Total assets | $ | 486,479 | $ | 526,321 | |||||||
| Total liabilities | $ | 69,219 | $ | 97,643 | |||||||
| Total stockholders’ equity | $ | 417,260 | $ | 428,678 | |||||||
Investor and Media Contact
Karla MacDonald
Chief Corporate Affairs Officer