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CAMBRIDGE, Mass., Aug. 09, 2018 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2018 and provided a business update.
“We continue to advance our programs for the treatment of Duchenne muscular dystrophy with preparations underway for our global, pivotal trial of investigational WVE-210201 for boys amenable to exon 51 skipping. Recently presented preclinical data demonstrating that our stereopure oligonucleotides can restore up to 90% of natural dystrophin in an animal model underscore the significant potential of our platform to address Duchenne muscular dystrophy,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “Through the rest of the year, we look forward to sharing Phase 1 safety data on WVE-210201, presenting advances in our Duchenne muscular dystrophy exon 53 skipping program, and maintaining strong momentum in the ongoing PRECISON-HD clinical program, the first clinical study conducted in the United States using an oligonucleotide approach for Huntington’s disease.”
Second Quarter Highlights and Business Update
Second Quarter 2018 Financial Results and Financial Guidance
Wave reported a net loss of $35.9 million in the second quarter of 2018 as compared to $24.6 million in the same period in 2017. The increase in net loss in the second quarter of 2018 was largely driven by increased research and development efforts and the continued growth of employee headcount to support Wave’s programs.
Research and development expenses were $32.5 million in the second quarter of 2018 as compared to $19.1 million in the same period in 2017. The increase in research and development expenses in the second quarter of 2018 was largely driven by increases in research, preclinical and clinical investments, further expansion of our manufacturing capabilities and facility-related expenses, along with the continued growth of employee headcount to support Wave’s programs.
General and administrative expenses were $8.9 million in the second quarter of 2018 as compared to $6.7 million in the same period in 2017. The increase in general and administrative expenses in the second quarter of 2018 was mainly driven by the increase in Wave’s employee headcount, as well as increases in professional service expenses and other general operating expenses.
Wave ended the second quarter of 2018 with $241.4 million in cash and cash equivalents as compared to $142.5 million as of December 31, 2017. The increase in cash and cash equivalents was primarily the result of the $170.0 million of cash received from Takeda, which was partially offset by Wave’s net loss of $71.1 million.
Wave expects that its existing cash and cash equivalents, together with expected and committed cash from existing collaborations, will enable it to fund its operating and capital expenditure requirements to the end of 2020.
About Wave Life Sciences
Wave Life Sciences is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases. Its chemistry platform enables the creation of highly specific, well characterized oligonucleotides designed to deliver superior efficacy and safety across multiple therapeutic modalities. The company’s pipeline is initially focused on neurological disorders and extends across several other therapeutic areas. For more information, please visit www.wavelifesciences.com.
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; the protocol, design and endpoints of our ongoing and planned clinical trials; the future performance and results of our programs in clinical trials; 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 in clinical trials; our identification of future candidates and their therapeutic potential; the anticipated therapeutic benefits of our potential therapies compared to others; our advancing of therapies across multiple modalities and the anticipated benefits of that model; the anticipated benefits of our manufacturing process and our internal manufacturing facility; our future growth; the potential benefits of our stereopure compounds compared with stereorandom compounds, our drug discovery platform and 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 continue to build and 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 processes; the success of our platform in identifying viable candidates; the continued development and acceptance of nucleic acid therapeutics as a class of drugs; 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 our collaborators and partners; our ability to manufacture drug material to support our programs and growth; our ability to obtain, maintain and protect 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 uses, 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)
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||241,431||$||142,503|
|Current portion of accounts receivable||15,000||1,000|
|Prepaid expenses and other current assets||11,243||6,985|
|Total current assets||267,674||150,488|
|Accounts receivable, net of current portion||50,000||—|
|Property and equipment, net||32,384||27,334|
|Total long-term assets||86,069||31,355|
|Liabilities, Series A preferred shares and shareholders’ equity|
|Accrued expenses and other current liabilities||8,494||8,898|
|Current portion of capital lease obligation||—||16|
|Current portion of deferred rent||80||60|
|Current portion of deferred revenue||27,294||1,275|
|Current portion of lease incentive obligation||762||344|
|Total current liabilities||43,781||18,191|
|Deferred rent, net of current portion||4,864||4,214|
|Deferred revenue, net of current portion||149,921||7,241|
|Lease incentive obligation, net of current portion||6,474||3,094|
|Total long-term liabilities||162,792||16,168|
|Series A preferred shares, no par value; 3,901,348 shares issued and
outstanding at June 30, 2018 and December 31, 2017
|Ordinary shares, no par value; 29,293,350 and 27,829,079 shares issued
and outstanding at June 30, 2018 and December 31, 2017, respectively
|Additional paid-in capital||30,147||22,172|
|Accumulated other comprehensive income||201||116|
|Total shareholders’ equity||$||139,296||$||139,610|
|Total liabilities, Series A preferred shares and shareholders’ equity||$||353,743||$||181,843|
WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||32,547||19,103||61,743||33,843|
|General and administrative||8,905||6,667||16,906||12,517|
|Total operating expenses||41,452||25,770||78,649||46,360|
|Loss from operations||(36,573||)||(24,673||)||(72,348||)||(44,880||)|
|Other income (expense), net:|
|Interest income (expense), net||4||1||11||4|
|Other income (expense), net||(259||)||(64||)||84||(136||)|
|Total other income (expense), net||679||419||1,385||640|
|Loss before income taxes||(35,894||)||(24,254||)||(70,963||)||(44,240||)|
|Income tax provision||—||(343||)||(172||)||(1,453||)|
|Net loss per share attributable to ordinary
shareholders—basic and diluted
|Weighted-average ordinary shares used in
computing net loss per share attributable to
ordinary shareholders—basic and diluted
|Other comprehensive income (loss):|
|Foreign currency translation||$||36||$||3||$||85||$||18|