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Wave Life Sciences (WVE) investor relations material

Wave Life Sciences Study Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study Update summary8 Dec, 2025

Study Design and Objectives

  • INLIGHT is a randomized, double-blind, placebo-controlled Phase 1 trial in overweight or mildly obese adults (BMI ~32), with no diet or exercise modifications required and over 100 enrolled across US and Europe.

  • Dosing cohorts included single ascending doses of 75 mg, 240 mg, 400 mg, and 600 mg, with 32 subjects per therapeutic cohort and body composition measured by DEXA.

  • The study assesses safety, tolerability, pharmacokinetics, and pharmacodynamics, with exploratory endpoints including body composition, biomarkers, and body weight.

  • Baseline characteristics were balanced across arms, with mean BMI around 32 kg/m².

  • No diet or exercise modifications were instituted during the trial.

Key Interim Results

  • A single 240 mg dose of WVE-007 led to a 9.4% reduction in visceral fat, 4.5% reduction in total fat mass, and a 3.2% increase in lean mass at three months, with no significant changes in the placebo group.

  • Placebo-adjusted reductions in total fat mass and visceral fat were on par or greater than those seen with semaglutide at 12 weeks, but with preservation of lean mass.

  • Durable, dose-dependent reductions in serum Activin E (>75%) were achieved, supporting the potential for once or twice-yearly dosing.

  • All adverse events were mild, with no discontinuations, serious events, deaths, or clinically meaningful lab changes through 600 mg.

  • No clinically meaningful changes in lipids or other laboratory measurements, including liver function tests, were observed.

Mechanism and Differentiation

  • WVE-007 is a GalNAc-siRNA targeting INHBE (Inhibin E), reducing hepatic Activin E production and promoting adipocyte lipolysis, leading to fat loss while preserving muscle.

  • The approach is orthogonal to GLP-1s, which act via appetite suppression and often cause muscle loss.

  • Human genetic data support the mechanism, with INHBE loss-of-function carriers showing healthier metabolic profiles.

  • Proprietary SpiNA chemistry enhances silencing potency and durability, differentiating WVE-007 from other siRNA approaches.

  • Preclinical data in mice showed durable reductions in Activin E, significant fat loss, and muscle preservation after a single dose.

How does WVE-007 align with FDA's fat loss focus?
Prioritize Phase II settings for WVE-007
Expected fat loss kinetics beyond 3 months?
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Frequently asked questions

Wave Life Sciences Ltd. (WVE) is a biotechnology company leveraging its proprietary RNA medicines platform, PRISM, to develop transformative treatments for a range of genetic diseases. This platform enables the design, optimization, and production of novel stereopure oligonucleotides, aimed at correcting disease-causing mutations, modulating protein activity, and restoring functional protein production or reducing disease-promoting RNAs or proteins. Wave's diverse pipeline includes clinical programs targeting Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency, Huntington's disease, and a preclinical program for obesity, among others. Their approach includes multiple RNA-targeting modalities such as editing, splicing, RNA interference, and antisense silencing, showcasing their broad capabilities in addressing complex disease biology. The company is headquartered in Singapore, and its shares are listed on the Nasdaq.

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