Entrada Therapeutics, Inc. (TRDA) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended December 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss ...

-- Patients in Cohort 1 have progressed to the open label, Phase 2 portion of ELEVATE-44-201 -- -- Company on track to report ELEVATE-44-201 Cohort 1 data in Q2 2026, with Cohort 2 data by end of year -- BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced that an independent Data Monitoring Committee (DMC), per study protocol, has reviewed all available safety and PK data from the eight patients who completed dosing in Cohort 1 of the double-blinded, placebo-c ...

Summary of Entrada Therapeutics Conference Call Company Overview - **Company**: Entrada Therapeutics (NasdaqGM:TRDA) - **Focus**: Development of intracellular therapeutics, particularly for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) [4][6] - **Location**: Boston, with approximately 150-160 employees [4] - **New Initiatives**: Recently entered the ocular disease space, focusing on inherited retinal diseases, starting with Usher syndrome type 1A [4] Key Data Inflection Points - **Clinical Data Releases**: - Q2 2026: First clinical data set for ENTR-601-44 program at a 6 mg/kg dose, expected to show double-digit dystrophin levels and reestablish safety [6][10] - End of 2026: Data for 12 mg/kg dose from exon 44 and additional data from exon 45 [5][7] - Vertex's DM1 program data expected mid-2026 [7] Safety and Efficacy - **Safety Database**: Established a robust safety database from non-clinical studies and healthy volunteer data [6][9] - **Dystrophin Levels**: Aiming for double-digit dystrophin levels, with confidence based on extensive non-clinical data [9][10] - **Comparison with Peers**: Expecting to outperform Avidity's del-zota data, which established roughly 25% dystrophin levels above background [10] Competitive Landscape - **Differentiation**: Entrada's cyclic cell-penetrating peptide delivery mechanism is distinct from competitors like PepGen and Sarepta, which have faced safety liabilities [11][12] - **Regulatory Flexibility**: FDA has allowed dose escalation up to 18 mg/kg, indicating a favorable therapeutic index compared to competitors [13] Functional Data and Patient Outcomes - **Functional Benefit Measurement**: While initial data will focus on safety and dystrophin production, functional benefits are expected to be assessed in later cohorts [15][18] - **Background Dystrophin Levels**: Patients in the exon 44 cohort have 6%-9% background dystrophin, which may delay observable functional benefits [16][18] U.S. Study Enrollment - **FDA Approval**: Currently approved to enroll an adult study in the U.S. with plans to start in the second half of 2026, contingent on Q2 data [24][25] - **Dose Considerations**: Current U.S. study doses capped at 1.28 mg/kg, with potential discussions for higher doses based on new data [25][27] Future Exon Programs - **Pipeline Expansion**: The same endosomal escape vehicle (EEV) technology will be used for future exons (45, 50, 51), which is expected to de-risk these programs [30][31] - **Market Potential**: Aiming to capture a significant portion of the estimated $5 billion U.S. market for DMD treatments [35] Conclusion - **Strategic Positioning**: Entrada Therapeutics is positioned to leverage its unique delivery mechanism and extensive non-clinical data to establish itself in the DMD and DM1 markets, with a focus on safety, efficacy, and patient outcomes [41][42]

Company Overview - Entrada Therapeutics focuses on treating devastating diseases with intracellular targets [2] - The company is advancing multiple clinical programs for Duchenne muscular dystrophy (DMD) in the U.K., EU, and U.S. [2] - By 2026, Entrada expects to have four clinical stage programs in its DMD franchise [2] Clinical Progress - Entrada highlighted significant progress across its EEV portfolio for neuromuscular and ocular diseases [2] - The company is also making progress in its partnership for myotonic dystrophy type 1 with Vertex, specifically with the program VX-670 [2] - The year is anticipated to have several value-driving catalysts for the company [2]

Summary of Entrada Therapeutics FY Conference Call Company Overview - **Company**: Entrada Therapeutics (NasdaqGM:TRDA) - **Focus**: Treating debilitating diseases with intracellular targets, particularly in neuromuscular and ocular diseases - **Key Programs**: Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) in partnership with Vertex Key Points and Arguments Clinical Programs and Pipeline - Entrada is advancing multiple clinical programs for DMD, with expectations to have four clinical-stage programs by the end of 2026 [1][2] - The company has made significant progress in its EEV (endosomal escape vehicle) portfolio, particularly for neuromuscular diseases [3][4] - Upcoming data releases include: - ENTR-601-44 program: Top-line data expected in Q2 2026 - ENTR-601-45 program: First cohort data expected in mid-2026 - ENTR-601-50 program: Data expected by year-end 2026 [6][7][8] Financial Position - As of the end of 2025, Entrada had approximately $296 million in cash, providing a runway into Q3 2027 [10][43] Differentiation and Competitive Advantage - Entrada's approach utilizes a differentiated endosomal escape vehicle platform, achieving a 25-fold improvement in endosomal escape compared to competitors [11][18] - The company emphasizes low drug doses with high concentrations, reducing the risk of exposure and antibody response [12][29] - The strategy includes running clinical studies outside the U.S. to gather data for FDA discussions on accelerated approval [13][16] DMD and DM1 Programs - The DMD program aims for double-digit dystrophin production, which is crucial for efficacy [14] - The partnership with Vertex for the DM1 program includes significant financial incentives, with a total of $485 million in milestones [34] - The DM1 program is expected to complete enrollment and dosing by mid-2026 [35] Expansion into Ocular Diseases - Entrada announced its expansion into inherited retinal diseases, specifically targeting Usher syndrome type 2A, with a candidate named ENTR-801 [36][38] - This program addresses a significant unmet need, with approximately 15,000 patients in the U.S. and Europe lacking therapeutic options [37] Future Growth and Strategy - Entrada plans to continue expanding its pipeline into other intracellular targets and ocular diseases, with a focus on optimizing oligonucleotides and exploring new therapeutic areas [39][41] - The company aims to establish itself as a leader in the DMD space, with a substantial patient population of over 14,000 in the U.S. and Europe [33] Important but Overlooked Content - The company’s strategy includes a focus on safety, with no treatment-related adverse events reported in healthy volunteer studies [22] - The ability to achieve clinically relevant exon skipping and measurable protein production for at least 90 days in the ocular program is a significant milestone [38] - Entrada's approach to kidney safety is noteworthy, as it limits the risk of toxicity while increasing efficacy [29] This summary encapsulates the critical aspects of Entrada Therapeutics' conference call, highlighting its strategic direction, clinical advancements, and financial health.

Core Insights - Entrada Therapeutics is advancing its RNA-based therapeutic pipeline, focusing on neuromuscular and ocular diseases, with significant data expected in 2026 [2][3] Clinical Development Pipeline - The company is on track to report data from the first cohort of the ELEVATE-44-201 study in Q2 2026 and from ELEVATE-45-201 in mid-2026 [1][3] - Entrada plans to initiate a global Phase 1/2 MAD clinical study of ENTR-601-50 by the end of 2026 and submit regulatory applications for ENTR-601-51 in 2026 [1][3] - The company has completed dosing of Cohort 1 for ENTR-601-44 and is transitioning to the open-label Phase 2 portion [3] - ENTR-801 has been selected as the first clinical candidate for treating Usher syndrome type 2A, with a second candidate expected to be nominated in 2026 [1][5] Financial Position - Entrada has a cash runway anticipated into Q3 2027, indicating strong financial health to support ongoing and future clinical programs [1][6] Upcoming Events - The company will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, showcasing its development progress [2][7]

Company Overview - Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines that target intracellular mechanisms previously deemed inaccessible [2] - The company utilizes its proprietary Endosomal Escape Vehicle (EEV™) technology to enhance the intracellular delivery of therapeutics across various organs and tissues, aiming to improve therapeutic efficacy [2] - Entrada is advancing a diverse portfolio of RNA- and protein-based programs, particularly targeting neuromuscular and ocular diseases [2] Product Development - The lead oligonucleotide programs are aimed at treating patients with Duchenne muscular dystrophy who are amenable to exon 44, 45, 50, and 51 skipping [2] - Entrada has partnered to develop VX-670, a clinical-stage program for myotonic dystrophy type 1 [2] Upcoming Events - Dipal Doshi, the CEO of Entrada Therapeutics, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 PM PT [1] - A live webcast of the presentation will be available on Entrada's Investor Relations website and will be archived for 30 days post-event [1]

分组1 - Entrada Therapeutics (TRDA) reported a 3Q25 GAAP EPS loss of -$1.06 and revenue of $1.6 million [1] - Following the earnings report on November 6th, TRDA's stock increased by approximately 25% [1] 分组2 - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, focusing on biotechnology companies with innovative therapies [1] - The analysis emphasizes the importance of evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while considering financial fundamentals [1]

Financial Performance - Collaboration revenue decreased significantly to $1.614 million in Q3 2025 from $19.570 million in Q3 2024, a decline of $17.956 million[118]. - Net loss for Q3 2025 was $44.134 million, compared to a net loss of $14.032 million in Q3 2024, an increase in loss of $30.102 million[118]. - For the nine months ended September 30, 2025, collaboration revenue was $24.1 million, a significant decrease of $149.3 million from $173.4 million in 2024, primarily due to fewer costs incurred for VX-670[126]. - Net loss for the nine months ended September 30, 2025, was $104.6 million, compared to a net income of $64.5 million for the same period in 2024, a decline of $169.1 million[125]. Expenses - Research and development expenses increased to $38.361 million in Q3 2025 from $31.257 million in Q3 2024, an increase of $7.104 million[118]. - General and administrative expenses rose to $10.304 million in Q3 2025 compared to $9.971 million in Q3 2024, an increase of $333,000[118]. - Total operating expenses for Q3 2025 were $48.665 million, up from $41.228 million in Q3 2024, reflecting an increase of $7.437 million[118]. - Total research and development expenses for the nine months ended September 30, 2025, were $108.3 million, an increase of $16.4 million from $91.9 million in 2024, driven by higher direct research costs[127]. Cash and Funding - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $326.8 million, sufficient to fund operations into Q3 2027[99]. - The company has raised over $850.0 million in gross proceeds from stock sales and collaborations since inception, with $326.8 million in cash and marketable securities as of September 30, 2025[140]. - The company plans to file a new shelf registration statement to replace the prior one that will expire on November 7, 2025, allowing for future equity offerings[142]. - The company anticipates significant future funding requirements due to ongoing research and development expenses[152]. Strategic Developments - The company has two product candidates, ENTR-601-44 and ENTR-601-45, in clinical development for Duchenne muscular dystrophy (DMD)[99]. - The company expects to report data from the first cohort of the ENTR-601-44 study in Q2 2026 and from the first patient cohort of ENTR-601-45 in mid-2026[101]. - The company anticipates filing for EU regulatory clearance for ENTR-601-50 in the second half of 2026 and for ENTR-601-51 in 2026[100]. - Vertex Pharmaceuticals is on track to complete enrollment and dosing in the VX-670 trial in the first half of 2026[105]. Workforce and Operational Changes - A strategic plan approved on April 29, 2025, led to a workforce reduction of approximately 20%, incurring charges of $1.9 million[158]. - The company has entered into contracts with CROs and third-party manufacturers for preclinical research, which are cancellable upon prior written notice[156]. - The company remains classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of reduced reporting requirements[159][162]. Other Financial Metrics - Total interest and other income decreased to $3.6 million for the three months ended September 30, 2025, down from $5.8 million in 2024, reflecting changes in interest earned from debt securities and a decrease in marketable securities[123]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $96.3 million, driven by a net loss of $104.6 million[145]. - The company generated $87.7 million from investing activities for the nine months ended September 30, 2025, primarily from $212.1 million in maturities of marketable securities[147]. - Net cash provided by financing activities was $0.7 million for the nine months ended September 30, 2025, compared to $101.6 million for the same period in 2024[149][150].

Financial Position - Cash, cash equivalents, and marketable securities were $326.8 million as of September 30, 2025, down from $420.0 million as of December 31, 2024[6]. - The expected cash runway has been extended into Q3 2027, supported by the current cash position[1]. Revenue and Expenses - Collaboration revenue for Q3 2025 was $1.6 million, a significant decrease from $19.6 million in Q3 2024, primarily due to the completion of collaboration research activities related to VX-670[7]. - Research and development (R&D) expenses increased to $38.4 million in Q3 2025 from $31.3 million in Q3 2024, driven by costs associated with DMD programs and higher personnel costs[10]. - General and administrative (G&A) expenses rose to $10.3 million in Q3 2025 from $10.0 million in Q3 2024, mainly due to increased personnel costs[11]. - Total operating expenses for Q3 2025 were $48.7 million, compared to $41.2 million in Q3 2024[17]. - Net loss for Q3 2025 was $(44.1) million, compared to a net loss of $(14.0) million for the same period in 2024[11]. Clinical Development - The company is on track to report data from the first patient cohort of ELEVATE-44-201 in Q2 2026 and ELEVATE-45-201 in mid-2026[2]. - The company expects to initiate a Phase 1b MAD clinical study of ENTR-601-44 in the U.S. in the first half of 2026[8]. - The company filed for regulatory authorization in the U.K. to initiate ELEVATE-50-201, a global Phase 1/2 MAD clinical study of ENTR-601-50[1].