Entrada Completes ELEVATE-45 Cohort 1 and Starts 10 mg/kg Dosing
Cash, cash equivalents and marketable securities were $223.0 million as of June 30, 2026, and the company said the balance will fund operations into the third quarter of 2027.
Entrada Therapeutics (TRDA) completed enrollment and dosing of Cohort 1 in ELEVATE-45-201, a global Phase 1/2 multiple ascending dose study of ENTR-601-45 in ambulatory people living with Duchenne muscular dystrophy who are amenable to exon 45 skipping, and an independent Data Monitoring Committee recommended starting Cohort 2 at an increased dose of 10 mg/kg without protocol modification.
All eight participants in Cohort 1 moved into the open-label Phase 2 portion of the study. Cohort 2 dosing at 10 mg/kg is ongoing. The company expects to report Cohort 1 data from the 5 mg/kg MAD in October 2026, Cohort 2 data in the first half of 2027, and Cohort 3 data (up to 15 mg/kg) afterward, if needed.
That DMC green light is the quarter’s clinical inflection. In the first quarter, Entrada had only completed enrollment and initiated dosing in Cohort 1 of ELEVATE-45-201. By June, the committee had reviewed all available safety and pharmacokinetic data and cleared the higher dose, putting the exon 45 program on a faster path toward the functional readouts the company has flagged for late 2026 and 2027.
The exon 44 franchise also advanced. Entrada completed enrollment for Cohort 2 of ELEVATE-44-201, the MAD portion of the study of ENTR-601-44 in ambulatory DMD participants amenable to exon 44 skipping. Previously announced Cohort 1 results achieved the primary objective of favorable safety and tolerability, with no discontinuations and no serious adverse events, and showed early functional benefits in Time to Rise and Time to Rise velocity versus placebo. A long-term extension protocol, ENTR-DMD-202, was accepted by U.K. and European authorities. The company is on track to report Cohort 1 (6 mg/kg) open-label data by year-end 2026, with Cohort 2 MAD (12 mg/kg) data expected in the first quarter of 2027 and Cohort 3 (up to 18 mg/kg) to follow, if needed.
For the planned U.S. study ELEVATE-44-102, Entrada plans to re-engage with the FDA to discuss increasing the planned starting dose after reviewing Cohort 1 safety, pharmacokinetic and pharmacodynamic data, and will update on study design and timing after those interactions. The company also received MHRA and Research Ethics Committee authorization to start a Phase 1/2 MAD study of ENTR-601-50 in exon 50-skipping-amenable patients, and completed CTA-enabling studies for ENTR-601-51, the largest exon-skipping-amenable sub-population. It expects to submit additional global regulatory applications after reviewing data from its lead programs.
Vertex completed enrollment and continues dosing in the MAD portion of the GALILEO Phase 1/2 trial of VX-670 in myotonic dystrophy type 1. Vertex is on track to complete dosing and report results in the second half of 2026. Entrada also announced its first ocular candidate, ENTR-801, for Usher syndrome type 2A, and plans to announce a second clinical candidate in inherited retinal disease in the second half of 2026.
Cash, cash equivalents and marketable securities were $223.0 million as of June 30, 2026, compared with $295.7 million as of December 31, 2025. The decrease was primarily driven by cash used to fund operations and, based on current operating plans, the June 30 balance will be sufficient to fund operations into the third quarter of 2027.
Collaboration revenue was $0.9 million in the second quarter of 2026, compared with $2.0 million in the same period in 2025. Research and development expenses were $35.4 million, compared with $37.9 million a year earlier; the decrease was primarily attributed to lower personnel and facility costs, partially offset by additional expenses related to DMD programs. General and administrative expenses were $10.5 million, compared with $10.9 million, primarily due to lower professional services costs. Net loss was $42.8 million, or $1.01 a share, compared with $43.1 million, or $1.04 a share, in the second quarter of 2025.
Chief Executive Officer Dipal Doshi said the company is entering a catalyst-rich period with several near-term clinical data readouts, including ELEVATE-45-201 Cohort 1 in October 2026, ELEVATE-44-201 Cohort 1 open-label data by year-end 2026, and ELEVATE-44-201 Cohort 2 data in the first quarter of 2027.