Entrada Therapeutics(US:TRDA)2025-08-06 11:06Executive Summary & Recent Corporate Highlights Second Quarter 2025 Business Updates Entrada Therapeutics advanced its DMD clinical pipeline, initiated new studies, progressed preclinical programs, and strengthened leadership Clinical-Stage Development Pipeline Entrada advanced multiple clinical programs for DMD, including ELEVATE-44-201 and ELEVATE-45-201, and progressed regulatory submissions and partnered DM1 and inherited retinal disease programs - First patient dosed in ELEVATE-44-201 (ENTR-601-44), a global Phase 1/2 multiple ascending dose (MAD) clinical study for ambulatory DMD patients amenable to exon 44 skipping, with data from Cohort 1 (6 mg/kg patient dose) anticipated in the first half of 2026123 - Initiated ELEVATE-45-201 (ENTR-601-45), a global Phase 1/2 MAD clinical study for ambulatory DMD patients amenable to exon 45 skipping, on track to dose the first patient in Q3 2025, with data from Cohort 1 (5 mg/kg) expected in mid-2026126 - Planned Phase 1b MAD clinical study of ENTR-601-44 (ELEVATE-44-102) in ambulatory and non-ambulatory adults living with DMD in the U.S. is on track to initiate in the first half of 20266 - Global regulatory applications for ENTR-601-50 are expected in Q4 2025 and for ENTR-601-51 in 202636 - Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 for myotonic dystrophy type 1 (DM1), with enrollment and dosing expected to complete in H1 20266 - Advanced two inherited retinal disease programs into lead optimization, with the first clinical candidate nomination expected by year-end 20256 Preclinical Pipeline The company generated positive preclinical data from programs outside its neuromuscular franchise, indicating a broader scope of therapeutic development - Generated positive preclinical data from programs outside its neuromuscular franchise, including new moieties4 Organizational Evolution Entrada strengthened its leadership team with strategic appointments to support accelerated clinical growth and other strategic priorities - Appointed Navid Khan, PhD, as Senior Vice President of Medical Affairs in August 202516 - Appointed Kiran Patki, MD, MSc, FFPM, as Senior Vice President of Clinical Development in July 202516 - Appointed Maha Radhakrishnan, MD, to the Company's Board of Directors in June 20256 Cash Position Entrada's cash, cash equivalents, and marketable securities decreased to $354.0 million as of June 30, 2025, but are projected to fund operations into Q2 2027 Cash, Cash Equivalents, and Marketable Securities | Metric | As of June 30, 2025 | As of Dec 31, 2024 | | :-------------------------------- | :------------------ | :----------------- | | Cash, cash equivalents and marketable securities | $354.0 million | $420.0 million | - Cash runway expected into Q2 2027 based on current operating plans15 Detailed Second Quarter 2025 Financial Results Collaboration Revenue Collaboration revenue significantly decreased in Q2 2025 to $2.0 million from $94.7 million in Q2 2024, primarily due to the substantial completion of research activities for the VX-670 collaboration Collaboration Revenue Overview | Period | 2025 (Q2) | 2024 (Q2) | Change | | :------- | :---------- | :---------- | :----- | | Revenue | $2.0 million | $94.7 million | -$92.7 million | - The decrease was primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-6707 Operating Expenses Total operating expenses increased to $48.8 million in Q2 2025 from $41.3 million in Q2 2024, driven by higher R&D costs for DMD programs and increased personnel costs Total Operating Expenses | Period | 2025 (Q2) | 2024 (Q2) | Change | | :------- | :---------- | :---------- | :----- | | Total operating expenses | $48.8 million | $41.3 million | +$7.5 million | Research & Development (R&D) Expenses R&D expenses increased to $37.9 million in Q2 2025 from $32.0 million in Q2 2024, primarily due to additional costs for DMD programs and higher personnel costs Research & Development Expenses | Period | 2025 (Q2) | 2024 (Q2) | Change | | :------- | :---------- | :---------- | :----- | | R&D Expenses | $37.9 million | $32.0 million | +$5.9 million | - The increase was primarily driven by additional costs incurred related to the Company's DMD programs, as well as higher personnel costs (including non-cash, stock-based compensation)8 General & Administrative (G&A) Expenses G&A expenses rose to $10.9 million in Q2 2025 from $9.2 million in Q2 2024, mainly due to increased personnel costs, including non-cash stock-based compensation General & Administrative Expenses | Period | 2025 (Q2) | 2024 (Q2) | Change | | :------- | :---------- | :---------- | :----- | | G&A Expenses | $10.9 million | $9.2 million | +$1.7 million | - The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation)9 Net Income (Loss) Entrada reported a net loss of $(43.1) million for Q2 2025, a significant decline from a net income of $55.0 million in Q2 2024, resulting in a basic net loss per share of $(1.04) Net Income (Loss) Summary | Period | 2025 (Q2) | 2024 (Q2) | Change | | :------- | :---------- | :---------- | :----- | | Net Income (Loss) | $(43.1) million | $55.0 million | -$98.1 million | | Net (Loss) Income per share, basic | $(1.04) | $1.61 | -$2.65 | Condensed Consolidated Financial Statements (Unaudited) Condensed Consolidated Statements of Operations The unaudited statements of operations show a significant decrease in collaboration revenue and an increase in operating expenses, leading to a net loss for both the three and six months ended June 30, 2025, compared to net income in the prior year periods Condensed Consolidated Statements of Operations (in millions of dollars, except per share data) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :-------------------------------- | :---------- | :---------- | :---------- | :---------- | | | 2025 | 2024 | 2025 | 2024 | | Collaboration revenue | $1.95 | $94.69 | $22.51 | $153.81 | | Operating expenses: | | | | | | Research and development | 37.88 | 32.04 | 69.95 | 60.64 | | General and administrative | 10.92 | 9.24 | 21.20 | 18.64 | | Total operating expenses | 48.80 | 41.27 | 91.15 | 79.28 | | (Loss) income from operations | (46.85) | 53.42 | (68.64) | 74.54 | | Other income: | | | | | | Interest and other income | 3.92 | 4.37 | 8.37 | 8.58 | | Total other income | 3.92 | 4.37 | 8.37 | 8.58 | | (Loss) income before provision for income taxes | (42.93) | 57.79 | (60.27) | 83.12 | | Provision for income taxes | 0.18 | 2.76 | 0.18 | 4.59 | | Net (loss) income | $(43.10) | $55.03 | $(60.45)