Entrada Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Collaboration revenue was $0.9 million for the quarter ended September 30, 2026, a decrease from $1.6 million in the same period of 2025.
• Research and development expenses were $32.4 million for the quarter, down from $38.4 million in the prior year period, driven by lower preclinical costs for Duchenne programs and facility-related costs.
• General and administrative expenses were $10.2 million for the quarter, compared to $10.3 million in the prior year period, primarily due to lower professional services costs.
• Net loss was $39.7 million for the quarter, an improvement from $44.1 million in the same period of 2025.
• Cash, cash equivalents, and marketable securities totaled $193.0 million as of September 30, 2026, down from $295.7 million as of December 31, 2025.
• Total assets were $266.9 million as of September 30, 2026, compared to $377.4 million as of December 31, 2025.
• Total liabilities were $68.6 million as of September 30, 2026, compared to $71.2 million as of December 31, 2025.
• Total stockholders' equity was $198.3 million as of September 30, 2026, compared to $306.1 million as of December 31, 2025.

Guidance and Future Outlook:

• All ELEVATE-44-201 Cohort 1 participants have completed open-label dosing, with data expected by year-end 2026.
• The company is on track to report ELEVATE-44-201 Cohort 2 data in Q1 2027.
• ELEVATE-45-201 Cohort 2 enrollment is complete, with data expected in the first half of 2027.
• The company expects four clinical data readouts through the first half of 2027, including anticipated Phase 1/2 data from partner Vertex's GALILEO study in myotonic dystrophy type 1 during the second half of 2026.
• Cash runway is expected to extend into Q4 2027 based on current operating plans.
• The company plans to nominate a second clinical candidate for an ocular disease by year-end 2026.
• The company expects to submit additional regulatory applications for ENTR-601-50 and ENTR-601-51 following data reviews and will provide specific timeline guidance once the new strategy is finalized.

Business Segments and Product Lines:

• ELEVATE-44-201 (ENTR-601-44):
  • Cohort 1 (6 mg/kg): Open-label period data expected by year-end 2026; previously announced MAD data met primary objectives of favorable safety and tolerability with no discontinuations or serious adverse events.
  • Cohort 2 (12 mg/kg): Enrollment complete, dosing ongoing.
  • Cohort 3 (18 mg/kg): An independent Data Monitoring Committee recommended initiating this cohort at the highest planned dose in October 2026; enrollment is ongoing.
  • ELEVATE-44-102: The company intends to engage with the FDA regarding study design and timing for this adult patient study following safety and pharmacokinetic reviews.
• ELEVATE-45-201 (ENTR-601-45):
  • Cohort 1 (5 mg/kg): Data reported in October 2026 met primary objectives of favorable safety and tolerability; headache was the most common treatment-emergent adverse event; no hypomagnesemia or renal safety concerns were noted; all participants have progressed to the open-label Phase 2 portion.
  • Cohort 2 (10 mg/kg): Enrollment complete, dosing ongoing.
  • Cohort 3 (up to 15 mg/kg): Data pending DMC review of Cohort 2 safety data.
  • The U.S. FDA granted orphan drug designation for ENTR-601-45 in October 2026.
• VX-670 (Vertex Partnership):
  • Vertex completed enrollment and dosing in the MAD portion of the GALILEO global Phase 1/2 trial for myotonic dystrophy type 1.
  • Vertex is on track to share interim results in the second half of 2026.
• Preclinical Pipeline:
  • The company generated compelling preclinical data for programs targeting ocular and metabolic diseases.
  • ENTR-801 was announced as the first ocular candidate for the potential treatment of Usher syndrome type 2A (USH2A).
• ELEVATE-LTE:
  • A long-term extension study (ENTR-DMD-202) is available for participants from ELEVATE-44-201 and ELEVATE-45-201 to collect longer-term safety and efficacy data.

Market and Competitive Landscape:

• The company is advancing multiple clinical programs for Duchenne muscular dystrophy (DMD) in the U.K., EU, and U.S., targeting exon 44, 45, 50, and 51 skipping amenable patients.
• The company is expanding into inherited retinal diseases, noting high unmet need in this sector.
• The company is evaluating options to optimize clinical study execution for its lead programs.

Risks and Challenges:

• The press release includes standard forward-looking statement risks regarding uncertainties in product development, clinical study conduct, regulatory clearance timing, and the predictive nature of preclinical data.
• Risks include the potential for actual results to differ materially from plans, including the sufficiency of cash resources to fund operating expenses.
• Specific risks involve the timing of clinical readouts, the ability to initiate planned studies (such as ELEVATE-44-102), and the success of the partnership with Vertex.

Management Commentary and Tone:

• CEO Dipal Doshi described the October Cohort 1 data from ELEVATE-45-201 as the third consecutive readout demonstrating encouraging safety and tolerability.
• Management expressed confidence that initial dose cohorts support the safety profile of lead Duchenne programs and that upcoming readouts will define the potential of investigational medicines.
• The tone highlights an "important period of clinical catalysts" as the company advances its pipeline toward delivering transformative medicines for serious neuromuscular diseases.
• Management noted that ELEVATE-44-201 Cohort 1 open-label data will provide insights into underlying biology and the durability of early functional improvements.

Other Key Points:

• The company announced the nomination of ENTR-801 for Usher syndrome type 2A as part of an expanded preclinical pipeline.
• The U.S. FDA Office of Orphan Products Development granted orphan drug designation for ENTR-601-45.
• Upcoming investor conferences include the Guggenheim Healthcare Innovation Conference on November 9, 2026, and the Evercore Healthcare Conference on December 1, 2026.
• The company maintains a partnership with Vertex for the development of VX-670 for myotonic dystrophy type 1.