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Entrada Therapeutics Reports Third Quarter 2024 Financial Results

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Entrada Therapeutics (NASDAQ: TRDA) reported Q3 2024 financial results with a net loss of $14.0 million, compared to net income of $35.5 million in Q3 2023. The company reported $449.3 million in cash, cash equivalents and marketable securities, extending runway into 2027. Collaboration revenue decreased to $19.6 million from $43.7 million year-over-year. R&D expenses increased to $31.3 million from $22.2 million, while G&A expenses rose to $10.0 million from $7.5 million.

The company presented additional Phase 1 clinical trial data for ENTR-601-44 and new preclinical data for ENTR-601-45 at the World Muscle Society Congress. Global regulatory filings for Phase 2 trials of both compounds are planned for Q4 2024.

Entrada Therapeutics (NASDAQ: TRDA) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando una perdita netta di 14,0 milioni di dollari, rispetto a un utile netto di 35,5 milioni di dollari nel terzo trimestre 2023. L'azienda ha comunicato di avere 449,3 milioni di dollari in disponibilità liquide, equivalenti liquidi e titoli negoziabili, estendendo così la sua liquidità fino al 2027. Le entrate da collaborazioni sono diminuite a 19,6 milioni di dollari, rispetto ai 43,7 milioni di dollari dell'anno precedente. Le spese per R&S sono aumentate a 31,3 milioni di dollari, rispetto ai 22,2 milioni di dollari, mentre le spese generali e amministrative sono salite a 10,0 milioni di dollari dai 7,5 milioni di dollari.

L'azienda ha presentato dati aggiuntivi sui trial clinici di fase 1 per ENTR-601-44 e nuovi dati preclinici per ENTR-601-45 al Congresso della World Muscle Society. Le domande di registrazione globale per i trial di fase 2 di entrambi i composti sono programmate per il quarto trimestre 2024.

Entrada Therapeutics (NASDAQ: TRDA) reportó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 14,0 millones de dólares, en comparación con una ganancia neta de 35,5 millones de dólares en el tercer trimestre de 2023. La compañía reportó 449,3 millones de dólares en efectivo, equivalentes de efectivo y valores negociables, extendiendo su liquidez hasta 2027. Los ingresos por colaboraciones disminuyeron a 19,6 millones de dólares desde 43,7 millones de dólares en comparación con el año anterior. Los gastos de I+D aumentaron a 31,3 millones de dólares desde 22,2 millones de dólares, mientras que los gastos generales y administrativos subieron a 10,0 millones de dólares desde 7,5 millones de dólares.

La compañía presentó datos adicionales de ensayos clínicos de fase 1 para ENTR-601-44 y nuevos datos preclínicos para ENTR-601-45 en el Congreso de la Sociedad Mundial de Músculos. Se planean presentaciones regulatorias globales para los ensayos de fase 2 de ambos compuestos para el cuarto trimestre de 2024.

Entrada Therapeutics (NASDAQ: TRDA)는 2024년 3분기 재무 결과를 보고하며 1,400만 달러의 순손실을 기록했으며, 이는 2023년 3분기 3,550만 달러의 순이익에 비해 감소한 수치입니다. 이 회사는 4억 4,930만 달러의 현금, 현금성 자산 및 유가증권을 보유하고 있으며, 2027년까지의 자금을 확보하고 있습니다. 협력 수익은 전년 대비 4,370만 달러에서 1,960만 달러로 감소했습니다. 연구개발(R&D) 비용은 2,220만 달러에서 3,130만 달러로 증가했으며, 일반 및 관리(G&A) 비용은 750만 달러에서 1,000만 달러로 늘어났습니다.

이 회사는 세계근육학회에서 ENTR-601-44의 1상 임상 시험 추가 데이터와 ENTR-601-45에 대한 새로운 전임상 데이터를 발표했습니다. 두 화합물의 2상 시험에 대한 글로벌 규제 제출은 2024년 4분기로 계획되어 있습니다.

Entrada Therapeutics (NASDAQ: TRDA) a présenté ses résultats financiers du troisième trimestre 2024, affichant une perte nette de 14,0 millions de dollars, contre un revenu net de 35,5 millions de dollars au troisième trimestre 2023. L'entreprise a annoncé détenir 449,3 millions de dollars en espèces, équivalents de trésorerie et titres négociables, prolongeant ainsi sa liquidité jusqu'en 2027. Les revenus de collaboration ont diminué à 19,6 millions de dollars contre 43,7 millions de dollars d'une année sur l'autre. Les dépenses de R&D ont augmenté à 31,3 millions de dollars contre 22,2 millions de dollars, tandis que les dépenses générales et administratives ont grimpé à 10,0 millions de dollars contre 7,5 millions de dollars.

L'entreprise a présenté des données supplémentaires sur l'essai clinique de phase 1 pour ENTR-601-44 et de nouvelles données précliniques pour ENTR-601-45 lors du Congrès de la Société Mondiale des Muscles. Des dépôts réglementaires mondiaux pour des essais de phase 2 des deux composés sont prévus pour le quatrième trimestre 2024.

Entrada Therapeutics (NASDAQ: TRDA) berichtete für das dritte Quartal 2024 über finanzielle Ergebnisse mit einem Nettoverlust von 14,0 Millionen Dollar, verglichen mit einem Nettoertrag von 35,5 Millionen Dollar im dritten Quartal 2023. Das Unternehmen meldete 449,3 Millionen Dollar in Bargeld, Barmitteln und handelbaren Wertpapieren, was die finanzielle Stabilität bis 2027 verlängert. Kooperationsumsätze sanken von 43,7 Millionen Dollar auf 19,6 Millionen Dollar im Jahresvergleich. Die F&E-Ausgaben stiegen auf 31,3 Millionen Dollar von 22,2 Millionen Dollar, während die allgemeinen und administrativen Ausgaben auf 10,0 Millionen Dollar von 7,5 Millionen Dollar anstiegen.

Das Unternehmen präsentierte zusätzliche Daten aus klinischen Phase-1-Studien für ENTR-601-44 und neue präklinische Daten für ENTR-601-45 auf dem Weltmuskelgesellschaftskongress. Globale regulatorische Einreichungen für Phase-2-Studien beider Verbindungen sind für das vierte Quartal 2024 geplant.

Positive
  • Strong cash position of $449.3 million, providing runway into 2027
  • Phase 1 clinical trial data shows positive results for ENTR-601-44
  • Partner Vertex completed SAD portion and initiated MAD portion of Phase 1/2 trial for VX-670
Negative
  • Net loss of $14.0 million compared to net income of $35.5 million in Q3 2023
  • Collaboration revenue decreased 55% to $19.6 million from $43.7 million YoY
  • R&D expenses increased 41% to $31.3 million YoY
  • G&A expenses increased 33% to $10.0 million YoY

Insights

The Q3 2024 results reveal a mixed financial picture for Entrada Therapeutics. The company maintains a strong cash position of $449.3 million, bolstered by a $100 million direct offering and a $75 million milestone payment from Vertex. However, collaboration revenue declined significantly to $19.6 million from $43.7 million year-over-year.

Operating expenses increased notably, with R&D expenses up 41% to $31.3 million and G&A expenses rising 33% to $10.0 million. The company swung to a net loss of $14.0 million compared to a net income of $35.5 million in Q3 2023. Despite higher expenses, the extended cash runway into 2027 provides substantial operational flexibility for their clinical development programs.

The clinical progress across Entrada's Duchenne muscular dystrophy (DMD) pipeline shows promising momentum. Key developments include positive Phase 1 data for ENTR-601-44 and encouraging preclinical results for ENTR-601-45, both supporting upcoming regulatory filings in Q4 2024. The advancement of partner Vertex's VX-670 program for DM1 from SAD to MAD phase indicates strong clinical execution.

The company's three-pronged approach to DMD treatment, targeting different exon-skipping populations (ENTR-601-44, -45 and -50), demonstrates a comprehensive strategy to address various genetic mutations in DMD. The positive pharmacokinetic and safety profile data presented at the World Muscle Society strengthens their regulatory position.

– Presented additional data from the Phase 1 clinical trial ENTR-601-44-101 and new preclinical data supporting ENTR-601-45 for DMD at 2024 World Muscle Society Annual Congress

– On track to submit global regulatory filings for planned Phase 2 clinical trials for both ENTR-601-44 and ENTR-601-45 in Q4 2024

– Vertex announced the completion of the single ascending dose (SAD) and the initiation of the multiple ascending dose (MAD) portions of global Phase 1/2 clinical trial for partnered program VX-670 in people with DM1 –

– Cash runway expected into 2027 with $449 million in cash, cash equivalents and marketable securities as of September 30, 2024

BOSTON, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets long considered inaccessible. The Company today reported financial results for the third quarter ended September 30, 2024 and highlighted recent business updates.

“We are highly encouraged by the progress in our Duchenne franchise, with both ENTR-601-44 and ENTR-601-45 achieving significant milestones since June. The recent data presented at the World Muscle Society enhance our proposed regulatory packages, and we remain on track with our global regulatory filings for both ENTR-601-44 and ENTR-601-45,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “Our team continues to work hard across our entire Duchenne franchise in an effort to bring these important potential therapies to the Duchenne community. In addition, we are pleased with the momentum that our partner, Vertex, is building with VX-670 for the potential treatment of DM1 where no approved therapies are available. The successful completion of the SAD and subsequent initiation of the MAD portion of their ongoing Phase 1/2 study underscores the potential of this therapeutic opportunity.”

Recent Corporate Highlights

  • In October 2024, the Company presented data in support of its Duchenne franchise at the 29th Annual Congress of the World Muscle Society in Prague, Czechia. The poster presentations included additional positive data from its Phase 1 clinical trial (ENTR-601-44-101), reinforcing the candidate's pharmacokinetic and safety profile in patients, and new preclinical data showing both exon skipping and dystrophin production for ENTR-601-45.
  • The Company remains on track to submit regulatory applications in Q4 2024 to initiate separate global Phase 2 clinical trials for ENTR-601-44 and ENTR-601-45. Submission of regulatory applications to initiate a global Phase 2 clinical trial for its third Duchenne candidate, ENTR-601-50, in patients who are exon 50 skipping amenable, is expected in 2025.
  • In September 2024, Entrada announced the promotion of Natarajan Sethuraman PhD, previously Chief Scientific Officer, to President of Research and Development. Dr. Sethuraman has brought broad experience to the Company since its inception and has been invaluable in advancing ENTR-601-44 into the clinic.
  • In November 2024, Vertex announced the completion of the SAD portion of the global Phase 1/2 clinical trial for VX-670 in people with DM1. Vertex has initiated the MAD portion of the Phase 1/2 study, in which the safety and efficacy of VX-670 will be evaluated.

Upcoming Conferences

The Company will present at the following events during the fourth quarter of 2024:

  • ASGCT-MDA Breakthroughs in Muscular Dystrophy, Chicago, IL from November 19-20
  • Evercore ISI HealthCONx Conference, Coral Gables, FL on December 4
  • Oppenheimer Movers in Rare Disease Summit, New York, NY on December 12

Third Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $449.3 million as of September 30, 2024, compared to $352.0 million as of December 31, 2023. The increase was primarily a result of the $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 September 30, 2024 will be sufficient to fund its operations into 2027.

Collaboration Revenue: Collaboration revenue was $19.6 million for the third quarter of 2024, compared to $43.7 million for the same period in 2023. The decrease was primarily a result of fewer costs incurred for VX-670 research activities during the third quarter of 2024 as compared to the third quarter of 2023.

Research & Development (R&D) Expenses: R&D expenses were $31.3 million for the third quarter of 2024, compared to $22.2 million for the same period in 2023. The increase was 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 $10.0 million for the third quarter of 2024, compared to $7.5 million for the same period in 2023. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation).

Net (Loss) Income: Net loss was $(14.0) million for the third quarter of 2024, compared to a net income of $35.5 million for the same period in 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 and 50 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 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 its ability to provide a potential treatment for patients, the translatability of the data from the Phase 1 clinical trial for ENTR-601-44 to future clinical trials for ENTR-601-44, expectations regarding the ability of Entrada’s preclinical studies and clinical trials to demonstrate safety and efficacy of its therapeutic candidates, and other positive results, expectations regarding the timing of regulatory filings for the planned Phase 2 clinical trials for ENTR-601-44 and ENTR-601-45 in the fourth quarter of 2024, and ENTR-601-50 in 2025, the ability to recruit for and complete global Phase 2 clinical trials for ENTR-601-44, ENTR-601-45 and ENTR-601-50, the potential of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, and EEV platform, and the continued development and advancement of ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of Duchenne and the partnered product candidate VX-670 for the treatment of myotonic dystrophy type 1, 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, the potential therapeutic benefits of its EEV candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, and the sufficiency of its cash resources into 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 trials; 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 trials; whether results from preclinical studies or clinical trials will be predictive of the results of later preclinical studies and clinical trials; 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 September 30, Nine Months Ended September 30,
  2024   2023   2024  2023 
Collaboration revenue$19,570  $43,735  $173,384 $87,165 
Operating expenses:       
Research and development 31,257   22,191   91,900  71,593 
General and administrative 9,971   7,532   28,606  23,639 
Total operating expenses 41,228   29,723   120,506  95,232 
(Loss) income from operations (21,658)  14,012   52,878  (8,067)
Other income:       
Interest and other income 5,766   4,051   14,346  10,926 
Total other income 5,766   4,051   14,346  10,926 
(Loss) income before provision for income taxes (15,892)  18,063   67,224  2,859 
(Benefit from) provision for income taxes (1,860)  (17,398)  2,729   
Net (loss) income$(14,032) $35,461  $64,495 $2,859 
Net (loss) income per share, basic$(0.35) $1.07  $1.79 $0.09 
Net (loss) income per share, diluted$(0.35) $1.02  $1.72 $0.08 
Weighted‑average common shares outstanding, basic 40,629,602   33,281,287   36,118,930  32,942,958 
Weighted‑average common shares outstanding, diluted 40,629,602   34,775,451   37,583,486  34,289,411 


ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data (Unaudited)
(In thousands)
    
 September 30,
2024
 December 31,
2023
  
Cash, cash equivalents and marketable securities$        449,344 $        351,969
Total assets$        554,590 $        469,192
Total liabilities$        132,143 $        226,832
Total stockholders’ equity$        422,447 $        242,360
      

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


FAQ

What was Entrada Therapeutics (TRDA) Q3 2024 net loss?

Entrada Therapeutics reported a net loss of $14.0 million for Q3 2024, compared to a net income of $35.5 million in Q3 2023.

How much cash does Entrada Therapeutics (TRDA) have as of Q3 2024?

Entrada Therapeutics had $449.3 million in cash, cash equivalents and marketable securities as of September 30, 2024.

When will Entrada Therapeutics (TRDA) submit regulatory filings for ENTR-601-44 and ENTR-601-45 Phase 2 trials?

Entrada Therapeutics plans to submit global regulatory filings for Phase 2 clinical trials for both ENTR-601-44 and ENTR-601-45 in Q4 2024.

Entrada Therapeutics, Inc.

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