Wave Life Sciences Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update – BioSpace

CAMBRIDGE, Mass., March 02, 2020 (GLOBE NEWSWIRE) -- WAVE Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases, today announced financial results for the fourth quarter and full year ended December 31, 2019 and provided a business update.

We continue to advance our innovative, CNS-focused pipeline of stereopure oligonucleotides across Huntingtons disease, amyotrophic lateral sclerosis, frontotemporal dementia and other central nervous system diseases. Despite the disappointment of discontinuing our Duchenne program last year, we are advancing more than a dozen programs across discovery and development with several exciting milestones ahead in 2020, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. In December 2019, we shared the first clinical results from an allele-selective program for Huntingtons disease. Initial results from PRECISION-HD2 demonstrated a reduction in mutant huntingtin protein, with a safety profile that supports the addition of a higher dose cohort, and no change in total huntingtin protein as compared to placebo. In the second half of 2020, we expect to initiate clinical development for our SNP3 program as well as our C9orf72 program, both of which have benefitted from novel advances in our PRISM platform. In addition, we are pleased by recent progress across multiple CNS programs we are working on in collaboration with Takeda. Finally, we presented proof-of-concept data for our RNA-editing program in January, which demonstrated endogenous ADAR engagement in vitro. We expect to have initial in vivo results in 2020, and we look forward to sharing further updates on this exciting new modality.

Business update Wave is building a leading genetic medicines company focused on realizing the potential of stereopure oligonucleotides in diseases of the central nervous system, liver, and eye. Waves pipeline includes more than a dozen programs across discovery and development, spans multiple modalities and targets, and is intended to deliver transformational medicines to patients and families.

Central nervous system (CNS) diseases Updates for PRECISION-HD clinical trials of WVE-120101 and WVE-120102 in Huntingtons disease

Advancing third allele-selective Huntingtons disease program (SNP3) towards clinical development.

Advancing C9orf72 preclinical program for ALS and FTD towards clinical development

Pipeline of CNS programs progressing in collaboration with Takeda

Ophthalmologic diseases

RNA-editing

Neuromuscular disease

Fourth Quarter and Full Year 2019 Financial Results and Financial Guidance Wave reported a net loss of $56.8 million in the fourth quarter of 2019 as compared to $37.9 million in the same period in 2018. The company reported a net loss of $193.6 million for the year ended December 31, 2019 as compared to $146.7 million for the year ended December 31, 2018. The increase in net loss in the fourth quarter and the year ended December 31, 2019 was largely driven by increased research and development efforts and continued organizational growth, both of which included costs and efforts, including manufacturing, in preparation for the potential commercialization of suvodirsen.

Research and development expenses were $49.1 million in the fourth quarter of 2019 as compared to $39.8 million in the same period in 2018. Research and development expenses for the full year were $175.4 million as compared to $134.4 million for the prior year. The increase in research and development expenses in the fourth quarter and full year was primarily due to increased external expenses related to our clinical activities, including our HD programs and our now discontinued DMD programs, as well as increased investments in PRISM and other research and development expenses.

General and administrative expenses were $13.8 million for the fourth quarter of 2019 as compared to $12.8 million for the same period in the prior year. General and administrative expenses were $48.9 million in 2019 as compared to $39.5 million in 2018. The increase in general and administrative expenses in the fourth quarter and full year was mainly driven by continued organizational growth to support Waves 2019 corporate goals.

Wave ended 2019 with $147.2 million in cash and cash equivalents as compared to $174.8 million as of December 31, 2018. The decrease in cash and cash equivalents was primarily the result of Waves year-to-date net loss of $193.6 million, partially offset by the $161.8 million in net proceeds from the January 2019 follow-on offering.

Wave expects that its existing cash and cash equivalents, together with expected and committed cash from existing collaborations, will enable Wave to fund its operating and capital expenditure requirements into the third quarter of 2021.

Investor Conference Call and Webcast Wave management will host an investor conference call today at 8:00 a.m. ET to discuss the companys fourth quarter and full year 2019 operating results and provide an update on the companys development programs. The conference call may be accessed by dialing (866) 220-8068 (domestic) or +1 (470) 495-9153 (international) and entering conference ID 3994836. The live webcast may be accessed by visiting the investor relations section of the Wave Life Sciences corporate website at http://www.ir.wavelifesciences.com. Following the webcast, a replay will be available on the website.

About PRISM PRISM is Wave Life Sciences proprietary discovery and drug development platform that enables genetically defined diseases to be targeted with stereopure oligonucleotides across multiple therapeutic modalities. PRISM combines the companys unique ability to construct stereopure oligonucleotides with a deep understanding of how the interplay among oligonucleotide sequence, chemistry and backbone stereochemistry impacts key pharmacological properties. By exploring these interactions through iterative analysis of in vitro and in vivo outcomes and artificial intelligence-driven predictive modeling, the company continues to define design principles that are deployed across programs to rapidly develop and manufacture clinical candidates that meet pre-defined product profiles.

About Wave Life Sciences Wave Life Sciences (NASDAQ: WVE) is a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases. Wave aspires to develop best-in-class medicines across multiple therapeutic modalities using PRISM, the companys proprietary discovery and drug development platform that enables the precise design, optimization and production of stereopure oligonucleotides. Driven by a resolute sense of urgency, the Wave team is targeting a broad range of genetically defined diseases so that patients and families may realize a brighter future. To find out more, please visit http://www.wavelifesciences.com and follow Wave on Twitter @WaveLifeSci.

Forward-Looking Statements

This press release contains forward-looking statements concerning our goals, beliefs, expectations, strategies, objectives and plans, and other statements that are not necessarily based on historical facts, including statements regarding the following, among others: the anticipated commencement, patient enrollment, data readouts and completion of our clinical trials, and the announcement of such events; the protocol, design and endpoints of our ongoing and planned clinical trials; the future performance and results of our programs in clinical trials; future preclinical activities and programs; regulatory submissions; the progress and potential benefits of our collaborations with partners; the potential of our in vitro and in vivo preclinical data to predict the behavior of our compounds in humans; our identification of future candidates and their therapeutic potential; the anticipated therapeutic benefits of our potential therapies compared to others; our ability to design compounds using multiple modalities and the anticipated benefits of that model; the anticipated benefits of our proprietary manufacturing processes and our internal manufacturing capabilities; the potential benefits of PRISM and our stereopure oligonucleotides compared with stereorandom oligonucleotides; the benefit of nucleic acid therapeutics generally; the strength of our intellectual property; and the anticipated duration of our cash runway. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the following: our ability to finance our drug discovery and development efforts and to raise additional capital when needed; the ability of our preclinical programs to produce data sufficient to support our clinical trial applications and the timing thereof; our ability to maintain the company infrastructure and personnel needed to achieve our goals; the clinical results of our programs, which may not support further development of product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; our effectiveness in managing future clinical trials and regulatory interactions; the effectiveness of PRISM; the continued development and acceptance of oligonucleotides as a class of medicines; our ability to demonstrate the therapeutic benefits of our candidates in clinical trials, including our ability to develop candidates across multiple therapeutic modalities; our dependence on third parties, including contract research organizations, contract manufacturing organizations, collaborators and partners; our ability to manufacture or contract with third parties to manufacture drug material to support our programs and growth; our ability to obtain, maintain and protect our intellectual property; our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties; and competition from others developing therapies for similar indications, as well as the information under the caption Risk Factors contained in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) and in other filings we make with the SEC from time to time. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

WAVE LIFE SCIENCES LTD. UNAUDITED CONSOLIDATED BALANCE SHEETS (In thousands, except share amounts)

WAVE LIFE SCIENCES LTD. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts)

Investor Contact: Kate Rausch 617-949-4827 krausch@wavelifesci.com

Media Contact: Alicia Suter 617-949-4817 asuter@wavelifesci.com

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Wave Life Sciences Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update - BioSpace