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CAMBRIDGE, Mass., March 01, 2019 (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 reported financial results for the fourth quarter and full year ended December 31, 2018 and outlined its plans for building a fully integrated company.
“Our achievements throughout 2018 established a strong foundation upon which we are building a world-class and fully integrated genetic medicines company,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “For 2019, we will remain keenly focused on broadening our pipeline and preparing to launch suvodirsen for the treatment of Duchenne muscular dystrophy in boys who are amenable to exon 51 skipping. Realizing our long-term commitment to those affected by rare genetic diseases will require us to continue to advance our ongoing clinical programs, meaningfully expand into new therapeutic areas such as ophthalmology and continue to invest in and evolve our robust and innovative discovery and drug development platform.”
Building a Fully Integrated Genetic Medicines Company
Wave is committed to building upon its discovery, clinical development and manufacturing capabilities and continuing its rapid transformation to become a fully integrated genetic medicines company aspiring to deliver best-in-class medicines. To achieve this ambition, the company is focused on the following priority objectives:
Fourth Quarter Highlights and Business Update
Fourth Quarter and Full Year 2018 Financial Results and Financial Guidance
Wave reported a net loss of $37.9 million in the fourth quarter of 2018 as compared to $30.8 million in the same period in 2017. The company reported a net loss of $146.7 million for the year ended December 31, 2018 as compared to $102.0 million for the year ended December 31, 2017. The increase in net loss in the fourth quarter and the year ended December 31, 2018 was largely driven by increased research and development efforts and continued organizational growth to support Wave’s corporate goals.
Research and development expenses were $39.8 million for the fourth quarter of 2018 as compared to $25.4 million for the same period in 2017. Research and development expenses for the full year were $134.4 million as compared to $79.3 million for the prior year. The increase in research and development expenses in the fourth quarter and full year 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 PRISM.
General and administrative expenses were $12.8 million for the fourth quarter of 2018 as compared to $6.9 million for the same period in the prior year. General and administrative expenses were $39.5 million in 2018 as compared to $27.0 million in 2017. The increase in general and administrative expenses in the fourth quarter and full year was mainly driven by increases in employee headcount to support Wave’s corporate goals, as well as increases in professional service expenses and other general operating expenses.
Wave ended 2018 with $174.8 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 in cash received from Takeda when the collaboration took effect, which was partially offset by Wave’s year-to-date net loss of $146.7 million.
On January 28, 2019, Wave closed a follow-on underwritten public offering of 3,950,000 ordinary shares for gross proceeds of $150.1 million, and on February 26, 2019, Wave closed on the sale of an additional 592,500 ordinary shares pursuant to the underwriters’ option (on the same terms and conditions as the initial closing) for gross proceeds of an additional $22.5 million. Net proceeds to Wave from the offering are expected to be approximately $161.6 million, after deducting underwriting discounts and commissions and estimated offering expenses.
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 to the end of 2020.
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 company’s 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 company’s 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 www.wavelifesciences.com and follow Wave on Twitter @WaveLifeSci.
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; 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 facility; our future growth and anticipated transition to a fully integrated commercial-stage company; 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 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 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 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)
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||174,819||$||142,503|
|Current portion of accounts receivable||10,000||1,000|
|Prepaid expenses and other current assets||17,454||6,985|
|Total current assets||202,273||150,488|
|Accounts receivable, net of current portion||50,000||—|
|Property and equipment, net||39,931||27,334|
|Total long-term assets||93,667||31,355|
|Liabilities, Series A preferred shares and shareholders’ equity|
|Accrued expenses and other current liabilities||14,736||8,898|
|Current portion of capital lease obligation||—||16|
|Current portion of deferred rent||115||60|
|Current portion of deferred revenue||100,945||1,275|
|Current portion of lease incentive obligation||1,156||344|
|Total current liabilities||130,041||18,191|
|Deferred rent, net of current portion||5,132||4,214|
|Deferred revenue, net of current portion||68,156||7,241|
|Lease incentive obligation, net of current portion||9,247||3,094|
|Total long-term liabilities||84,677||16,168|
|Series A preferred shares, no par value; 3,901,348 shares issued
and outstanding at December 31, 2018 and 2017
|Ordinary shares, no par value; 29,472,197 and 27,829,079 shares issued
and outstanding at December 31, 2018 and 2017, respectively
|Additional paid-in capital||37,768||22,172|
|Accumulated other comprehensive income (loss)||153||116|
|Total shareholders’ equity||73,348||139,610|
|Total liabilities, Series A preferred shares and shareholders’ equity||$||295,940||$||181,843|
WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
|For the Year Ended December 31,|
|Research and development||134,428||79,309||40,818|
|General and administrative||39,509||26,975||15,994|
|Total operating expenses||173,937||106,284||56,812|
|Loss from operations||(159,523||)||(102,391||)||(55,720||)|
|Other income (expense), net:|
|Interest income (expense), net||22||6||337|
|Other income (expense), net||9,549||(331||)||(50||)|
|Other income (expense), net||12,939||1,253||542|
|Loss before income taxes||(146,584||)||(101,138||)||(55,178||)|
|Income tax benefit (provision)||(69||)||(842||)||(482||)|
|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||37||407||(332||)|
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