WAVE Life Sciences NASDAQ: WVE reported a wider second-quarter loss as it increased investment in its obesity and RNA-editing programs, while outlining several clinical and regulatory milestones expected in the second half of 2026.
The company reported second-quarter revenue of $2.3 million, down from $8.7 million a year earlier, related to its ongoing collaboration with GSK. Research and development expense increased to $51.3 million from $43.5 million, while general and administrative expense rose to $24.8 million from $18 million. Net loss widened to $69.4 million, compared with a $50.5 million loss in the prior-year period.
Chief Financial Officer Kyle Moran said Wave ended the quarter with $490.6 million in cash, cash equivalents and marketable securities, which the company expects will fund operations into the third quarter of 2028. Moran added that anticipated GSK milestone payments in the second half of 2026 are not included in the company’s cash-runway estimate.
Obesity Study Moves Into Phase IIa
Wave said dosing has begun in the Phase IIa portion of its INLIGHT trial evaluating WVE-007, an siRNA candidate targeting inhibin E for obesity. The placebo-controlled study will enroll individuals with body mass indexes of 35 to 50 and associated comorbidities, including cohorts with and without type 2 diabetes.
The trial will study two dose levels, 240 milligrams and 400 milligrams, across four cohorts of 40 participants each. Patients will receive doses on day one and day 85 and will be followed for 12 months, with initial key assessments at day 85.
Chief Medical Officer Dr. Chris Wright said the study will measure body composition through MRI, liver fat through MRI-PDFF, HbA1c, lipid levels and other measures. The design is intended to assess not only body weight and fat loss but also potential applications in metabolic dysfunction-associated steatohepatitis, or MASH, type 2 diabetes and other cardiometabolic diseases.
In prior Phase I data from otherwise healthy participants with lower BMI, the company reported reductions in serum activin A of up to 88% that persisted for at least seven and a half months after a single dose. Chief Scientific Officer Dr. Erik Ingelsson said the findings supported the potential for once- or twice-yearly dosing. The company also reported reductions in visceral fat, subcutaneous fat and waist circumference while preserving lean mass.
During the question-and-answer session, Chief Executive Officer Dr. Paul Bolno said the Phase IIa trial was designed to evaluate whether WVE-007 can achieve at least 5% weight loss versus placebo, a threshold he described as important from a regulatory perspective. He said the company will also assess liver fat, HbA1c, lipids, muscle retention and other cardiometabolic measures to identify additional development opportunities.
Wave is also preparing clinical studies of WVE-007 in combination with incretin therapies and as a maintenance treatment following discontinuation of incretins. Bolno said the company remains on track to initiate both studies this year. The company expects to provide additional Phase I data this year, including results from a 600-milligram cohort that could further inform the drug’s durability.
AATD Candidate Heads Toward FDA Meeting
Wave’s RNA-editing candidate WVE-006 is being developed for alpha-1 antitrypsin deficiency, or AATD. The company said the Food and Drug Administration granted its request for a meeting planned for the end of summer to discuss a potential accelerated-approval pathway.
Bolno said the planned meeting will be Wave’s first discussion with the FDA on a potential accelerated pathway for WVE-006. The company expects to provide an update after it receives written feedback from the agency.
Wright said WVE-006 is designed to address both lung and liver manifestations of AATD by reducing the disease-associated Z-AAT protein and restoring production of functional M-AAT protein. Wave has completed enrollment and dosing in the 200-milligram, 400-milligram and 600-milligram cohorts of its RestorAATion-2 study. Data from the 600-milligram monthly cohort are expected in the second half of 2026 and are intended to help select an optimal dose regimen.
The company previously reported that three months of treatment at 200 milligrams every two weeks and 400 milligrams monthly produced what it characterized as a therapeutic profile consistent with its objectives, including Z-AAT reduction and production of wild-type M-AAT.
PNPLA3 Program Remains on Track for CTA Filing
Wave also said it remains on track to submit a clinical trial application in 2026 for WVE-008, an RNA-editing candidate for homozygous PNPLA3 I148M liver disease. The company estimates that about 9 million people in the U.S. and Europe carry two copies of the variant and said these individuals have a substantially higher risk of death from liver disease than non-carriers.
According to Wave, WVE-008 aims to correct the PNPLA3 variant and restore normal protein function, rather than silence the gene. Executives said recent clinical data from PNPLA3-silencing approaches have shown dose-dependent increases in liver enzymes, which they said reinforces the company’s focus on RNA editing.
Ingelsson said Wave’s target of more than 50% editing is based on human genetic observations comparing homozygous and heterozygous carriers of the variant. The planned first-in-human study will use previously genotyped populations to identify homozygous carriers and accelerate enrollment, according to Wright.
DMD Partnership Discussions Continue
Wave said it continues to explore partnerships for its Huntington’s disease and Duchenne muscular dystrophy programs. Bolno said the company remains interested in partnering WVE-N531, its Duchenne candidate, before filing a new drug application.
He cited an evolving regulatory environment in Duchenne muscular dystrophy, including an anticipated filing for potential full approval of golodirsen, as a factor in the company’s evaluation of the appropriate development path. Wave also plans to hold an investor day in the fall focused on platform advancements and its bifunctional modality work.
About WAVE Life Sciences (NASDAQ:WVE)
WAVE Life Sciences is a clinical-stage genetic medicines company focused on the discovery and development of stereopure oligonucleotide therapies designed to address serious diseases with high unmet medical need. Leveraging proprietary chemistry and precision synthesis, WAVE engineers drug candidates with defined stereochemistry to optimize potency, safety and manufacturability. This approach aims to enhance target specificity and improve therapeutic profiles compared with traditional oligonucleotide medicines.
The company's pipeline includes programs in neuromuscular disorders such as Duchenne muscular dystrophy and neurodegenerative conditions including Huntington's disease, as well as early-stage cardiovascular and liver indications.
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