The company is also expanding its DMD discovery programs to explore additional exon targets beyond its current exon 51 and exon 53 skipping programs, specifically including exons 44, 45, 52, 54 and 55.
| • | | Pipeline expansion to rare, genetic eye diseases |
Last month, Wave announced plans to design and advance stereopure oligonucleotide therapeutics for the potential treatment of inherited retinal diseases. Wave’s research in ophthalmology is assessing four inherited retinal diseases, which typically begin in childhood or adolescence and commonly lead to progressive vision loss: retinitis pigmentosa due to a P23H mutation in the RHO gene, Stargardt disease, Usher syndrome type 2A and Leber congenital amaurosis 10.
Wave’s decision to expand its therapeutic pipeline into ophthalmology is supported by its data presented at the 14th Annual Meeting of the Oligonucleotide Therapeutics Society in October 2018. The data demonstrate that a single intravitreal injection of stereopure oligonucleotide in the eye ofnon-human primates resulted in greater than 95% knockdown of a target RNA in the retina for at least four months. Based on these data, the company is working to design development candidates that could achieve a therapeutic effect with only two doses per year.
Wave expects to announce its first ophthalmology development candidate in the second half of 2019.
| • | | PRECISION-HD Phase 1b/2a clinical trials |
ThePRECISION-HD program, which consists of two global Phase 1b/2a clinical trials evaluating investigational therapiesWVE-120101 andWVE-120102 for patients with Huntington’s disease, remains on track to deliver topline data in the first half of 2019. An open-label extension study to assess safety, tolerability and efficacy using validated clinical outcome measures is planned for patients as they complete the ongoing Phase 1b/2a trials.
| • | | Continued validation of Wave’s stereochemistry platform |
Wave shared advancements related to its novel stereochemistry platform at the 14th Annual Meeting of the Oligonucleotide Therapeutics Society in October 2018. The company’s latest findings provide further validation of Wave’s platform to precisely design, optimize and manufacture stereopure oligonucleotides. Presentations included preclinical data demonstrating that Wave’s stereochemical control of antisense oligonucleotides enhances target efficacy and enables broad tissue distribution and exposure.
Third Quarter 2018 Financial Results and Financial Guidance
Wave reported a net loss of $37.6 million in the third quarter of 2018 as compared to $25.5 million in the same period in 2017. The increase in net loss in the third quarter of 2018 was largely driven by increased research and development efforts to support achievement of Wave’s corporate goals.
Research and development expenses were $32.9 million in the third quarter of 2018 as compared to $20.1 million in the same period in 2017. The increase in research and development expenses in the third quarter of 2018 was primarily due to increases in research, preclinical and clinical activities, further expansion of our manufacturing capabilities and facility-related expenses, and related organizational growth to support Wave’s advancing and expanding pipeline.
General and administrative expenses were $9.8 million in the third quarter of 2018 as compared to $7.6 million in the same period in 2017. The increase in general and administrative expenses in the third quarter of 2018 was mainly driven by the increase in employee headcount, as well as increases in professional services and other general operating expenses.