BOSTON, June 02, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced that the Company granted an aggregate of 23,820 restricted stock units (“RSUs”) to six newly-hired non-executive employees under the Company’s 2025 Inducement Equity Plan (the “Inducement Plan”), effective as of June 1, 2025. The inducement grants were previously approved by the Compensation Committee of the Company’s Board of Directors, as a material inducement to the new employees’ entry into employment wit ...

Core Insights - Entrada Therapeutics is set to initiate the ELEVATE-45-201 clinical study in Q3 2025, following authorization from health authorities in multiple countries under the EU Clinical Trial Regulation [1][2] - ELEVATE-45-201 is a Phase 1/2 study focusing on ENTR-601-45, targeting patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 45 skipping, addressing a significant unmet medical need [2][4] Company Overview - Entrada Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines aimed at intracellular targets, utilizing its proprietary Endosomal Escape Vehicle (EEV™) technology [5] - The company is advancing a robust pipeline of RNA- and protein-based programs for neuromuscular and ocular diseases, with a focus on DMD therapies targeting exon 44, 45, 50, and 51 skipping [5] Clinical Study Details - ELEVATE-45-201 is a global, two-part, randomized, double-blind placebo-controlled study evaluating the safety, tolerability, and effectiveness of ENTR-601-45 in ambulatory DMD patients [2] - Part A of the study will involve approximately 24 patients, with dosing every six weeks across three cohorts, ranging from 5 mg/kg to 15 mg/kg [2] - Part B will further assess the optimal dose for safety and efficacy, including functional outcomes and quality of life measures [2] Product Information - ENTR-601-45 is a proprietary EEV™-conjugated phosphorodiamidate morpholino oligomer (PMO) designed to address the underlying cause of DMD by restoring the mRNA reading frame for dystrophin protein production [3] - The therapy targets a specific subpopulation of DMD patients who are amenable to exon 45 skipping, with the potential to produce a functional but slightly shortened dystrophin protein [3] Disease Context - Duchenne muscular dystrophy (DMD) is a rare genetic disorder caused by mutations in the DMD gene, leading to inadequate dystrophin production and progressive muscle weakness [4] - An estimated 41,000 individuals in the U.S. and Europe are affected by DMD, with approximately 9% being amenable to exon 45 skipping [4]

Financial Data and Key Metrics Changes - The company has generated significant safety data in human trials, which has allowed for the identification of a starting dose for their first patient trial in Duchenne muscular dystrophy (DMD) [8] - The company has cash runway extending into Q2 2027, which is considered unusual compared to peers [36] Business Line Data and Key Metrics Changes - The Endosomal Escape Vehicle (EEV) platform has shown a remarkable target exposure of 50%, significantly higher than the historical benchmark of 1% for biological material delivery [7] - The company is advancing multiple programs in DMD, including exon skipping candidates 44, 45, 50, and 51, with 44 and 45 being prioritized due to larger patient populations and proven efficacy [17][18] Market Data and Key Metrics Changes - The current treatment landscape for DMD has evolved, with the company expecting to be a center of care for patients due to the high-quality dystrophin produced by their therapies [22] - There are emerging safety concerns with gene therapies from competitors, which may open up market opportunities for exon skipping modalities [22] Company Strategy and Development Direction - The company is focused on DMD and myotonic dystrophy type one (DM1) as primary therapeutic areas, leveraging the flexibility of the EEV platform for various indications [10][12] - The company aims to maintain optionality in commercialization strategies, considering both self-commercialization and partnerships [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the accelerated approval pathway for DMD treatments, citing a clear correlation between dystrophin levels and functional outcomes [28][29] - The company is excited about the potential of their ocular programs, which target genetically defined retinal diseases with significant unmet needs [40] Other Important Information - The company has made strategic decisions to focus investments on timely execution of clinical trials while maintaining a robust research framework [37] - The partnership with Vertex for the DM1 program is seen as a significant opportunity, with high-quality preclinical data supporting the collaboration [33] Q&A Session Summary Question: How did ENTRATA select indications for DMD and DM1? - The selection was based on a combination of serendipity and strategic assessments, with DMD being a well-understood biology and a clear regulatory pathway [10][11] Question: What is the current state of the DMD treatment landscape? - The future looks promising for DMD patients, with the company expecting to provide significant therapeutic options and high-quality dystrophin production [22] Question: How does ENTRATA view commercialization strategies for DMD? - The company sees a straightforward path to commercialization in DMD, with a focus on maintaining optionality in their approach [31] Question: What are the upcoming value inflection points for the VX-670 program? - The program is in Phase 1/2 trials, and the company is optimistic about the data being generated, which could lead to significant advancements [33] Question: What is the focus of the ocular programs? - The ocular programs are aimed at genetically defined retinal diseases, targeting areas with significant unmet needs [40]

分组1 - Entrada Therapeutics reported a quarterly loss of $0.42 per share, which was better than the Zacks Consensus Estimate of a loss of $0.78, representing an earnings surprise of 46.15% [1] - The company posted revenues of $20.56 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 111.61%, although this is a decline from $59.12 million in the same quarter last year [2] - Entrada Therapeutics has surpassed consensus EPS estimates for the last four quarters and has also topped consensus revenue estimates four times during the same period [2] 分组2 - The stock has underperformed, losing about 52.8% since the beginning of the year, compared to a decline of 4.3% for the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.81 on revenues of $9.22 million, and for the current fiscal year, it is -$3.32 on revenues of $35.86 million [7] - The Medical - Biomedical and Genetics industry, to which Entrada Therapeutics belongs, is currently in the top 33% of over 250 Zacks industries, indicating a favorable industry outlook [8]

Financial Position - The company has an accumulated deficit of $146.7 million as of March 31, 2025, and expects to continue generating operating losses and negative cash flows for the foreseeable future[95]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $382.5 million, which is projected to fund operations into the second quarter of 2027[99]. - Cash, cash equivalents, and marketable securities totaled $382.5 million as of March 31, 2025, with an accumulated deficit of $146.7 million[125]. - Net cash used in operating activities was $38.5 million for Q1 2025, compared to $25.5 million in Q1 2024, driven by a net loss and changes in operating assets and liabilities[128][129]. - The company anticipates that its cash resources will be sufficient to fund operations into the second quarter of 2027 based on current operating plans[134]. Revenue and Expenses - Collaboration revenue decreased to $20.6 million for the three months ended March 31, 2025, from $59.1 million in the same period of 2024, primarily due to a $38.7 million cumulative catch-up adjustment in 2024[118]. - Total operating expenses increased to $42.3 million in Q1 2025 from $38.0 million in Q1 2024, with research and development expenses rising by $3.5 million to $32.1 million[117][120]. - Net loss for the three months ended March 31, 2025, was $17.3 million, compared to a net income of $23.5 million in the same period of 2024, reflecting a change of $40.8 million[117]. - General and administrative expenses increased to $10.3 million in Q1 2025 from $9.4 million in Q1 2024, primarily due to increased personnel costs[121]. - Total interest and other income increased to $4.4 million in Q1 2025 from $4.2 million in Q1 2024, driven by higher interest income from investments[122]. Clinical Development and Strategic Plans - The company plans to initiate three clinical trials by year-end 2025 for its DMD franchise, including ENTR-601-44, ENTR-601-45, and ENTR-601-50[92]. - The company received authorization from the FDA to lift the clinical hold on ENTR-601-44 and plans to initiate a Phase 1b MAD clinical study in adult DMD patients in the first half of 2026[93]. - A new strategic plan was announced on April 29, 2025, focusing on DMD clinical candidates and reducing the workforce by approximately 20%[93]. - The company expects to incur significant expenses related to developing internal commercialization capabilities if any therapeutic candidates receive regulatory approval[95]. - The company has positive preclinical data for programs outside its neuromuscular franchise and plans to share its first clinical candidate in ocular disease later in 2025[94]. Growth Strategy and Market Risks - The company is focused on acquiring or in-licensing products, intellectual property, and technologies as part of its growth strategy[141]. - The company has added operational, financial, and management information systems to support product development[141]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing for delayed adoption of new accounting standards until certain revenue thresholds are met[140]. - The company will no longer qualify as a "smaller reporting company" effective December 31, 2024, impacting its reporting requirements[143]. - The company is exposed to interest rate market risk, but changes in interest rates have not materially impacted its financial position to date[145][146]. - Inflation has not had a material effect on the company's results of operations during the periods presented[147]. - The company is exposed to foreign currency exchange risk but has not experienced material effects from fluctuations to date[150]. Operational Adjustments - The company intends to implement a new strategic plan aimed at achieving expected cost savings, including a reduction in force[141]. - The company has not sold any shares under the 2023 ATM Program, which allows for sales of up to $150.0 million in common stock[126]. - The company has entered into license agreements with no material changes to commitments and contingencies as of March 31, 2025[139]. - The company may take advantage of exemptions under the JOBS Act, including reduced disclosure about executive compensation arrangements[149].

Core Insights - Entrada Therapeutics has received regulatory authorization in the EU for the ELEVATE-44-201 clinical study, focusing on ENTR-601-44 for patients with Duchenne muscular dystrophy amenable to exon 44 skipping [1][4] - The company plans to initiate ELEVATE-44-201 and ELEVATE-45-201 studies in Q2 and Q3 2025, respectively [1][2] - As of March 31, 2025, Entrada has $383 million in cash, cash equivalents, and marketable securities, providing a cash runway expected to last into Q2 2027 [1][5] Recent Developments - The first quarter of 2025 has been productive, with authorizations for two novel exon skipping programs, ENTR-601-44 and ENTR-601-45 [2] - The ELEVATE-44-201 study will be conducted in the U.K. and EU, with initiation expected in Q2 2025 [4] - The company is also advancing a partnered program with Vertex for myotonic dystrophy type 1, VX-670, which is progressing in clinical trials [2] Financial Performance - Collaboration revenue for Q1 2025 was $20.6 million, a decrease from $59.1 million in Q1 2024 [5] - Research and development expenses increased to $32.1 million in Q1 2025 from $28.6 million in Q1 2024, primarily due to costs associated with Duchenne programs [6] - General and administrative expenses rose to $10.3 million in Q1 2025 from $9.4 million in Q1 2024, mainly due to higher personnel costs [7] Operational Strategy - Entrada has initiated a strategic plan to focus resources on its expanding portfolio of Duchenne muscular dystrophy clinical candidates, which includes ENTR-601-44, -45, -50, and -51 [4] - The company has reduced its workforce by approximately 20% to streamline operations and enhance focus on key programs [4] - Upcoming investor conferences include the H.C. Wainwright Annual BioConnect Investor Conference on May 20, 2025, and the Jefferies Global Healthcare Conference on June 4, 2025 [4]

Company Updates - Entrada Therapeutics is set to initiate the ELEVATE-45-201 study in Q3 2025, focusing on the treatment of Duchenne muscular dystrophy (DMD) [1][2] - The company has received regulatory authorization from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the ELEVATE-45 program, with ongoing regulatory review in the EU [1][2] - ELEVATE-45 is the second of three novel exon skipping programs that Entrada plans to advance into global clinical development in 2025 [1] Clinical Study Details - ELEVATE-45-201 is a Phase 1/2 multiple ascending dose (MAD) clinical study evaluating the investigational product ENTR-601-45 for DMD patients with specific mutations [2] - The study will consist of two parts: Part A will assess safety and pharmacokinetics in approximately 24 patients, with dosing every six weeks ranging from 5 mg/kg to 15 mg/kg [2] - Part B will further evaluate the optimal dose for safety and efficacy, including functional outcomes and quality of life measures [2] Product Information - ENTR-601-45 is a proprietary Endosomal Escape Vehicle (EEV™)-conjugated phosphorodiamidate morpholino oligomer (PMO) targeting the underlying cause of DMD due to mutations in the DMD gene [3] - The therapy aims to restore the mRNA reading frame to allow for the production of a functional, albeit shortened, dystrophin protein [3] Disease Overview - Duchenne muscular dystrophy (DMD) is a rare genetic disorder caused by mutations in the DMD gene, leading to insufficient dystrophin production, which is critical for muscle cell integrity [4] - An estimated 41,000 individuals in the U.S. and Europe are affected by DMD, resulting in progressive muscle weakness and associated complications [4] Company Vision - Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines that target previously inaccessible intracellular sites [5] - The company is advancing a diverse portfolio of RNA, antibody, and enzyme-based programs for various diseases, including neuromuscular and metabolic disorders [5]

Entrada Therapeutics, Inc. (TRDA) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of a loss of $0.66 per share. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 104.55%. A quarter ago, it was expected that this company would post a loss of $0.67 per share when it actually produced a loss of $0.35, delivering a surprise of 47.76%.Over the last four quarters ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40969 ENTRADA THERAPEUTICS, INC. Securities registered pursuant to Section 12(b) of the Act: | Title of Each Class ...

– Received FDA authorization to initiate ELEVATE-44-102 in the U.S. – – Received MHRA authorization to initiate ELEVATE-44-201 in the U.K. – – Submitted regulatory filings to support global clinical studies for ENTR-601-44 in the EU, and ENTR-601-45 in the U.K. and EU – – Cash runway expected into Q2 2027 with $420 million in cash, cash equivalents and marketable securities as of December 31, 2024 – BOSTON, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial ...