Specificity of data disclosure for the INHBE program, knockdown level goals for the Activin E program, weight loss goals and dosing strategy, multiple dose strategy and study design, activin E reduction goals are the key contradictions discussed in Wave Life Sciences' latest 2025Q2 earnings call.
Pipeline and Program Progress:
-
reported significant progress in its pipeline, including the initiation and rapid advancement of the WVE-007 clinical program for obesity and the delivery of positive data from the FORWARD-53 clinical trial of WVE-N531 for DMD.
- The progress was driven by the successful implementation of the proprietary oligonucleotide chemistry platform and the company's commitment to developing a broad potential for RNA medicines.
Financial Performance and R&D Investments:
- The company's
revenue for the second quarter of 2025 was
$8.7 million, a decrease from
$19.7 million in the prior year quarter, primarily due to the timing of revenue recognition under the collaboration agreement with GSK.
- Research and development expenses were
$43.5 million for the second quarter of 2025, reflecting increased spending in the INHBE program and RNA editing programs.
- The increase in R&D expenses was primarily due to compensation-related expenses and other external expenses.
Obesity Program Advancement:
- The company expanded the second cohort of the
study for the INHBE program, which evaluates single doses of 007 in adults living with overweight or obesity, from 8 to 32 participants.
- The decision to expand the cohort was based on favorable safety and tolerability results, as well as robust Activin E reduction observed in cohort 1.
- The aim is to assess the potential for healthy weight loss and evaluate key measurements reflective of healthy weight loss, such as body composition and biomarkers.
DMD Program Milestones:
- Wave Life Sciences reported that following 48 weeks of treatment with WVE-N531, a statistically significant improvement of 3.8 seconds in time to rise versus the natural history was observed.
- The FORWARD-53 results demonstrated a clinically meaningful improvement in muscle health with exon skipping, including a significant reduction in fibrosis and decreases in creatine kinase and inflammatory biomarkers.
- The company plans to submit an NDA in 2026 for accelerated approval of N531 with a monthly dosing regimen.
Comments
No comments yet