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Wave Life Sciences Reports Third Quarter 2018 Financial Results and Provides Business Update
CAMBRIDGE, Mass., November 9, 2018 Wave Life Sciences Ltd. (NASDAQ: WVE), a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced financial results for the third quarter ended September 30, 2018 and provided a business update.
During the third quarter we maintained strong momentum in advancing our three clinical programs and expect to announce our companys first clinical readout later this year when we share topline safety results from the Phase 1 trial for WVE-210201, our investigational exon 51 skipping candidate for the treatment of Duchenne muscular dystrophy, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. Beyond our ongoing clinical programs, we spent much of the last quarter focused on expanding our discovery efforts into inherited retinal diseases and urgently driving additional Duchenne muscular dystrophy programs, including WVE-N531, our investigational exon 53 skipping candidate.
Third Quarter Highlights and Business Updates
WVE-210201 DMD exon 51 skipping program
Wave expects to announce topline safety data from its Phase 1 clinical trial evaluating WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping by the end of the fourth quarter of 2018. As patients complete the Phase 1 trial, they have the option to enroll in an ongoing open-label extension study in which they continue to receive WVE-210201.
In addition, the company remains on track to deliver an interim analysis of dystrophin expression in muscle biopsies from its ongoing open-label extension study in the second half of 2019.
Wave has designed a global, pivotal, placebo-controlled Phase 2/3 efficacy and safety clinical trial of WVE-210201 in DMD patients amenable to exon 51 skipping, informed by ongoing discussions with regulatory authorities and the DMD patient community. The study will be powered to assess clinical efficacy and will include dystrophin expression readouts as part of interim and final analyses.
WVE-N531 DMD exon 53 skipping program and additional DMD exon skipping programs
Wave is leveraging learnings from its ongoing DMD development and discovery efforts to advance WVE-N531, its preclinical program to target DMD in boys amenable to exon 53 skipping. Recent data presented at the 23rd International Annual Congress of the World Muscle Society demonstrated that WVE-N531 induced up to 71% dystrophin protein restoration in vitro in DMD patient-derived myoblasts compared with healthy human myoblasts as measured by Western Blot. Subject to submission of clinical trial applications and approval to proceed, Wave expects to deliver topline clinical data for WVE-N531 in the second half of 2020.
The following information was filed by Wave Life Sciences Ltd. (WVE) on Friday, November 9, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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