Entrada Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Entrada Therapeutics (NASDAQ: TRDA) reported strong Q4 and full year 2024 results, marking significant progress in their DMD therapeutic programs. The company secured FDA authorization for ELEVATE-44-102 in the US and MHRA authorization for ELEVATE-44-201 in the UK, while submitting regulatory filings for ENTR-601-44 in the EU and ENTR-601-45 in the UK and EU.

Financial highlights include $420 million in cash and equivalents as of December 31, 2024, extending runway into Q2 2027. The company reported collaboration revenue of $210.8 million for 2024, up from $129.0 million in 2023. R&D expenses increased to $125.3 million for 2024, while net income reached $65.6 million, compared to a net loss of $6.7 million in 2023.

Positive

• FDA removed clinical hold on ENTR-601-44
• Secured regulatory authorizations in US and UK for DMD programs
• Strong cash position of $420M, extending runway to Q2 2027
• Collaboration revenue increased 63% to $210.8M in 2024
• Achieved net income of $65.6M vs previous year loss
• Received $75M milestone payment for VX-670 advancement

Negative

• R&D expenses increased 25% to $125.3M
• G&A expenses rose 19% to $38.5M
• Q4 collaboration revenue declined to $37.4M from $41.8M YoY

Insights

Biotechnology Financial Analyst

Entrada Therapeutics' Q4 and full-year 2024 results showcase significant clinical and regulatory momentum alongside strengthened financial positioning. The FDA's removal of the clinical hold on ENTR-601-44 represents a important de-risking event that enables progression of their lead DMD program in the US market. With authorizations from both FDA and MHRA to initiate multiple clinical trials for their exon 44 skipping program, Entrada is executing a global development strategy for their DMD franchise.

The company's financial position has substantially improved, with $420 million cash on hand providing runway into Q2 2027. This represents approximately 2+ years of operational funding at current burn rates, giving management considerable flexibility to advance multiple clinical programs without near-term financing pressure. The transition to profitability (net income of $65.6 million for 2024 versus a loss in 2023) primarily reflects milestone payments from the Vertex collaboration rather than sustainable commercial revenue.

Entrada's R&D investment strategy appears well-calibrated, with increased spending ($125.3 million for 2024, up 25% year-over-year) supporting an expanding pipeline targeting multiple DMD exons. This multi-exon approach could potentially address approximately 30% of DMD patients through their exon 44, 45, 50, and 51 programs, representing a substantial market opportunity in a space where approved therapies like Sarepta's command premium pricing.

The Vertex partnership continues to deliver value through milestone payments while advancing VX-670 for myotonic dystrophy. Entrada's expansion beyond neuromuscular diseases into ocular indications demonstrates pipeline diversification that could reduce overall clinical development risk and open additional market opportunities. The company's oligonucleotide delivery platform technology appears to be proving versatile across multiple therapeutic areas, potentially supporting long-term growth beyond their current clinical candidates.

Biotechnology R&D Expert

Entrada's regulatory momentum across its DMD franchise represents significant de-risking of their lead programs. The FDA's removal of the clinical hold on ENTR-601-44 is particularly noteworthy as it validates the safety profile of their proprietary Endosomal Escape Vehicle (EEV) technology platform. This platform potentially offers differentiated oligonucleotide delivery compared to competitors by enhancing cellular penetration and potentially requiring less frequent dosing - a critical advantage in chronic diseases like DMD.

The company's strategic approach to target multiple exons (44, 45, 50, 51) is scientifically sound, potentially addressing approximately 30% of DMD patients through a portfolio of complementary therapeutics. The inclusion of both ambulatory and non-ambulatory patients in the ELEVATE-44-102 study is methodologically important, as it will provide insights into treatment efficacy across different disease stages and functional abilities.

The expansion beyond neuromuscular diseases into ocular indications demonstrates the versatility of their EEV platform. Ocular tissues present unique delivery challenges that have oligonucleotide therapeutic development; success here would further validate Entrada's technology. The planned announcement of an ocular clinical candidate in 2025 suggests confidence in their preclinical data.

The Vertex partnership for myotonic dystrophy provides external validation of Entrada's platform from an established player in RNA therapeutics. The continued enrollment in the MAD portion of the VX-670 study indicates satisfactory safety signals from earlier cohorts.

From a development perspective, Entrada's parallel regulatory strategy across multiple geographies (US, UK, EU) demonstrates operational sophistication and could accelerate overall development timelines. Their $420 million cash position appears sufficient to support multiple programs through meaningful clinical readouts, though manufacturing scale-up costs for oligonucleotide therapeutics can be substantial as programs advance toward potential commercialization.

– 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 results for the fourth quarter and full year ended December 31, 2024 and highlighted recent business updates.

“We are thrilled to begin 2025 with significant momentum. The entire Entrada team has been laser focused on advancing our Duchenne muscular dystrophy franchise, driven by our commitment to bringing a potential best-in-class therapy to patients and their families,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “The positive data we have presented to date has supported regulatory clearance in multiple geographies for our ELEVATE-44 program and has accelerated the pace at which we are advancing our exon 45, 50 and 51 programs. With a cash runway expected into the second quarter of 2027, we believe we have the people, pipeline and resources to deliver on our bold mission for patients and investors alike.”

Recent Corporate Highlights

• The U.S. Food and Drug Administration (FDA) removed the clinical hold on ENTR-601-44 in Duchenne muscular dystrophy (DMD) in February 2025. Entrada received FDA authorization to initiate ELEVATE-44-102, a Phase 1b Multiple Ascending Dose (MAD) clinical study of ENTR-601-44 in the U.S. in non-ambulatory and ambulatory adult patients living with DMD who are amenable to exon 44 skipping.
• In February 2025, the Company announced the receipt of authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate ELEVATE-44-201, a Phase 1/2 MAD clinical study of ENTR-601-44 in patients living with DMD who are amenable to exon 44 skipping. Entrada remains on track to initiate ELEVATE-44-201 in the U.K. in Q2 2025.
• Entrada submitted regulatory filings to initiate a global Phase 1/2 MAD clinical study of ENTR-601-45 in patients living with DMD who are amenable to exon 45 skipping in the U.K. and the EU. The Company remains on track to submit global regulatory applications for ENTR-601-50 in H2 2025 and for ENTR-601-51 in 2026.
• Vertex continues to enroll and dose the MAD portion of the Phase 1/2 clinical study for VX-670 in people with myotonic dystrophy type 1, in which the safety and efficacy of VX-670 will be evaluated.
• The Company has also generated positive preclinical data from programs outside of its neuromuscular franchise, which include new moieties, and expects to share its first clinical candidate in ocular disease later in 2025.

Upcoming Investor Conferences

• TD Cowen’s 45^th Annual Health Care Conference, Boston, MA on March 5
• 37^th Annual Roth Conference, Dana Point, CA on March 17

Fourth Quarter and Full Year 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $420.0 million as of December 31, 2024, compared to $352.0 million as of December 31, 2023. The increase was primarily a result of the approximately $100 million registered direct offering completed in June of 2024 and the receipt of the $75 million payment for the clinical advancement milestone for VX-670 that was achieved in the first quarter of 2024, offset 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, 2024 will be sufficient to fund its operations into the second quarter of 2027.

Collaboration Revenue: Collaboration revenue was $37.4 million for the fourth quarter of 2024 and $210.8 million for the full year of 2024, compared to $41.8 million and $129.0 million for the same periods in 2023, respectively.

Research & Development (R&D) Expenses: R&D expenses were $33.4 million for the fourth quarter of 2024 and $125.3 million for the full year of 2024, compared to $28.3 million and $99.9 million for the same periods in 2023, respectively. The increases were primarily driven by additional costs incurred for ENTR-601-44, ENTR-601-45, and ENTR-601-50, as well as higher personnel costs (including non-cash, stock-based compensation).

General & Administrative (G&A) Expenses: G&A expenses were $9.9 million for the fourth quarter of 2024 and $38.5 million for the full year of 2024, compared to $8.7 million and $32.3 million for the same periods in 2023, respectively. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation).

Net Income (loss): Net income was $1.1 million for the fourth quarter of 2024 and $65.6 million for the full year of 2024, compared to a net loss of $9.5 million for the fourth quarter of 2023 and $6.7 million for the full year of 2023.

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-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological 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, including its initiation in the U.K. in Q2 2025, the ability to recruit for and complete the ELEVATE-44-102 study in the U.S., the ability to recruit for and complete global Phase 2 clinical studies for ENTR-601-44, ENTR-601-45 and ENTR-601-50, expectations regarding the timing of regulatory filings for the planned Phase 2 clinical studies for ENTR-601-50 in 2025 and for ENTR-601-51 in 2026, the ability to recruit for and complete global Phase 2 clinical studies for ENTR-601-44, ENTR-601-45 and ENTR-601-50, 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; 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,
		2024				2023				2024				2023
Collaboration revenue	$	37,398			$	41,848			$	210,782			$	129,013
Operating expenses:
Research and development		33,406				28,291				125,306				99,884
General and administrative		9,859				8,652				38,465				32,291
Total operating expenses		43,265				36,943				163,771				132,175
(Loss) income from operations		(5,867	)			4,905				47,011				(3,162	)
Other income:
Interest and other income		5,128				4,292				19,474				15,218
Total other income		5,128				4,292				19,474				15,218
(Loss) income before provision for income taxes		(739	)			9,197				66,485				12,056
Benefit from (provision for) income taxes		1,870				(18,741	)			(859	)			(18,741	)
Net income (loss)	$	1,131			$	(9,544	)		$	65,626			$	(6,685	)
Net income (loss) per share, basic	$	0.03			$	(0.29	)		$	1.76			$	(0.20	)
Net income (loss) per share, diluted	$	0.03			$	(0.29	)		$	1.68			$	(0.20	)
Weighted‑average common shares outstanding, basic		40,842,849				33,368,901				37,306,363				33,050,319
Weighted‑average common shares outstanding, diluted		43,050,483				33,368,901				39,003,169				33,050,319

ENTRADA THERAPEUTICS, INC. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands)
	December 31, 2024				December 31, 2023
Cash, cash equivalents and marketable securities	$	419,998			$	351,969
Total assets	$	526,321			$	469,192
Total liabilities	$	97,643			$	226,832
Total stockholders’ equity	$	428,678			$	242,360

Investor and Media Contact
Caileigh Dougherty
Head of Investor Relations & Corporate Communications
cdougherty@entradatx.com

FAQ

What was Entrada Therapeutics (TRDA) revenue for full year 2024?

Entrada reported collaboration revenue of $210.8 million for full year 2024, up from $129.0 million in 2023.

How much cash does TRDA have and what is their runway?

TRDA has $420 million in cash, cash equivalents and marketable securities as of December 31, 2024, with runway expected into Q2 2027.

What regulatory approvals did TRDA receive for their DMD programs in early 2025?

FDA authorized ELEVATE-44-102 study in the US and MHRA authorized ELEVATE-44-201 study in the UK for ENTR-601-44 in DMD patients.

What was TRDA's net income for full year 2024?

Entrada reported net income of $65.6 million for full year 2024, compared to a net loss of $6.7 million in 2023.

When will TRDA initiate the ELEVATE-44-201 study in the UK?

Entrada plans to initiate ELEVATE-44-201 study in the UK in Q2 2025.