WVE — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-27

• The INLIGHT clinical program is also evaluating WVE-007 in combination with tirzepatide as a treatment for obesity and other cardiometabolic indications, including MASH. The placebo-controlled (3:1) Phase 2a combination trial will evaluate 240 mg and 400 mg doses of WVE-007 in combination with weekl…

• We also expect to initiate a clinical trial of WVE-007 as a maintenance therapy to preserve weight loss following discontinuation of incretin treatment in the fourth quarter of 2026.

• In October 2026, we announced alignment with the U.S. Food and Drug Administration (“FDA”) on key aspects of our planned registrational pathway for WVE-006. Planning is underway for a two-year registrational trial to support potential full approval, with a one-year interim analysis to support potent…

• Huntington’s disease (“HD”) and Duchenne muscular dystrophy (“DMD”)

• In HD, WVE-003 is our clinical-stage stereopure allele-selective oligonucleotide that incorporates our proprietary PN chemistry and is designed to selectively target rs362273, a variant of the single nucleotide polymorphism (“SNP”), “mHTT SNP3”, associated with the disease-causing mHTT mRNA transcri…

Text removed vs the prior filing · source: 10-Q · 2026-07-30

• We expect to initiate combination and maintenance trials of WVE-007 in the second half of 2026.

• Our request for a meeting regarding a potential accelerated approval pathway for WVE-006 was granted by the U.S. Food and Drug Administration (“FDA”). The meeting is scheduled for the end of summer 2026.

• In DMD, we are advancing WVE-N531, which is designed to skip exon 53 within the dystrophin gene – a therapeutic approach that would address approximately 8-10% of DMD cases. WVE-N531 is designed to cause the cellular splicing machinery to skip over exon 53 during pre-mRNA processing, which restores …

• FORWARD-53, the Phase 1b/2a proof-of-concept, open label trial of WVE-N531 included “Part A,” in which 3 boys received 3 doses of WVE-N531 at 10 mg/kg every two weeks and “Part B,” in which 11 boys initially received 10 mg/kg every two weeks for 48 weeks. In “Part B”, biopsy data was gathered from e…

• WVE-N531 uptake in myogenic stem cells, which are integral to muscle regeneration, and in myofibers;

Text added vs the prior filing · source: 10-Q · 2026-10-27

• On July 30, 2026, Paul B. Bolno, M.D., MBA, our President and Chief Executive Officer, terminated a Rule 10b5-1 Trading Plan that was originally adopted on May 26, 2026. Dr. Bolno’s former Rule 10b5-1 Trading Plan provided for the sale of up to an aggregate of 2,924,270 shares of our common stock. N…

Text removed vs the prior filing · source: 10-Q · 2026-07-30

• On May 22, 2026, Erik Ingelsson, M.D., Ph.D., our Chief Scientific Officer, adopted a Rule 10b5-1 Trading Plan providing for the sale of up to an aggregate of 131,250 of our ordinary shares pursuant to the terms of such Rule 10b5-1 Trading Plan. Dr. Ingelsson's Rule 10b5-1 Trading Plan is active unt…

• On May 22, 2026, Kyle Moran, CFA, our Chief Financial Officer, adopted a Rule 10b5-1 Trading Plan providing for the sale of up to an aggregate of 225,000 of our ordinary shares pursuant to the terms of such Rule 10b5-1 Trading Plan. Mr. Moran's Rule 10b5-1 Trading Plan is active until March 19, 2027…

• On May 22, 2026, Chandra Vargeese, Ph.D., our Chief Technology Officer, Head of Platform Discovery Sciences, adopted a Rule 10b5-1 Trading Plan providing for the sale of up to an aggregate of 152,786 of our ordinary shares pursuant to the terms of such Rule 10b5-1 Trading Plan. Dr. Vargeese’s Rule 1…

• Except as disclosed above, none of our directors or executive officers adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 tradin…