Clinical trials underway with next-generation candidates incorporating PN chemistry
Clinical data from PN chemistry programs expected in 2022
In vivo ADAR editing data for AATD program on track for 1H 2021
Wave to host investor conference call and webcast at 8:30 a.m. ET today
CAMBRIDGE, Mass., May 13, 2021 (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 first quarter ended March 31, 2021 and provided a business update.
“Despite our PRECISION-HD results at the end of the first quarter, it has been a productive start of the year for Wave and our team remains focused on advancing our clinical trials for ALS/FTD, HD and DMD. These new trials mark the transition of our next-generation programs into the clinic. We expect clinical data that will provide insight into PN chemistry and enable decision making on next steps for these programs next year,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “We have a deep and diverse pipeline of RNA therapeutics, each designed with our PN chemistry, which has been shown to increase potency, exposure and durability compared to our first-generation compounds in preclinical studies. We continue to produce compelling in vivo data, and we are advancing multiple programs for CNS indications, including Alzheimer’s disease, Parkinson’s disease and others, in collaboration with our partner Takeda. Our ADAR editing capability demonstrates the diversity of our genetic medicines toolkit and we are well-positioned to be leaders in the RNA editing field. We look forward to providing more updates on ADAR editing, including the first in vivo data from our AATD program, in the first half of this year.”
Recent Business Highlights and Upcoming Milestones
WVE-004 (C9orf72) for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD):
WVE-003 (SNP3) for Huntington’s disease (HD):
WVE-N531 for Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping:
ADAR editing:
Alpha-1 antitrypsin deficiency (AATD) program with ADAR editing:
First Quarter 2021 Financial Results and Financial Guidance
Wave reported a net loss of $42.5 million in the first quarter of 2021 as compared to $47.5 million in the same period in 2020.
Research and development expenses were $33.4 million in the first quarter of 2021 as compared to $41.2 million in the same period in 2020. The year-over-year decrease was primarily due to the decrease in external expenses related to Wave’s suvodirsen program, which was discontinued in December 2019, but had wind-down costs throughout 2020, as well as decreases in compensation-related expenses and other external expenses, partially offset by the increases in external expenses related to Wave’s clinical and preclinical activities related to its HD programs and its C9orf72 program for ALS and FTD.
General and administrative expenses were $10.1 million in the first quarter of 2021, as compared to $13.0 million in the same period in 2020. The year-over-year decrease was driven by decreases in compensation-related expenses and other external expenses.
Wave ended the first quarter of 2021 with $148.5 million in cash and cash equivalents, as compared to $184.5 million as of December 31, 2020. The decrease in cash and cash equivalents was mainly due to Wave’s year-to-date net loss, partially offset by the receipt of $8.0 million in net proceeds under Wave’s at-the-market equity program. In April 2021, Wave received an additional $30.0 million in committed research support under its collaboration with Takeda.
Wave expects that its existing cash and cash equivalents, together with expected and committed cash from its existing collaboration, will enable the company to fund its operating and capital expenditure requirements into the second quarter of 2023.
Investor Conference Call and Webcast
Wave management will host an investor conference call today at 8:30 a.m. ET to discuss the company’s first quarter and 2021 financial results and provide a business update. The conference call may be accessed by dialing (866) 220-8068 (domestic) or (470) 495-9153 (international) and entering conference ID: 7430859. The live webcast may be accessed from the investor relations section of the Wave Life Sciences corporate website at 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, including silencing, splicing and editing. 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 machine learning-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.
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 adaptive 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 product 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, including our novel PN backbone chemistry modifications, and our stereopure oligonucleotides compared with stereorandom oligonucleotides; the potential benefits of our novel ADAR-mediated RNA editing platform capabilities compared to others; the benefit of nucleic acid therapeutics generally; the strength of our intellectual property; the anticipated duration of our cash runway; and our expectations regarding the impact of the COVID-19 pandemic on our business. 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, including their receptiveness to our adaptive trial designs; our effectiveness in managing future clinical trials and regulatory interactions; the effectiveness of PRISM, including our novel PN backbone chemistry modifications ; the effectiveness of our novel ADAR-mediated RNA editing platform capability; 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; competition from others developing therapies for similar indications; the severity and duration of the COVID-19 pandemic and its negative impact on the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; and any other impacts on our business as a result of or related to the COVID-19 pandemic, 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)
March 31, 2021 | December 31, 2020 | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 148,535 | $ | 184,497 | ||
Current portion of accounts receivable | 30,000 | 30,000 | ||||
Prepaid expenses | 10,430 | 10,434 | ||||
Other current assets | 5,580 | 5,111 | ||||
Total current assets | 194,545 | 230,042 | ||||
Long-term assets: | ||||||
Property and equipment, net | 27,370 | 29,198 | ||||
Operating lease right-of-use assets | 15,720 | 16,232 | ||||
Restricted cash | 3,651 | 3,651 | ||||
Other assets | 1,361 | 115 | ||||
Total long-term assets | 48,102 | 49,196 | ||||
Total assets | $ | 242,647 | $ | 279,238 | ||
Liabilities, Series A preferred shares and shareholders’ equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 13,418 | $ | 13,795 | ||
Accrued expenses and other current liabilities | 6,661 | 11,971 | ||||
Current portion of deferred revenue | 24,763 | 91,560 | ||||
Current portion of operating lease liability | 3,838 | 3,714 | ||||
Total current liabilities | 48,680 | 121,040 | ||||
Long-term liabilities: | ||||||
Deferred revenue, net of current portion | 108,278 | 41,481 | ||||
Operating lease liability, net of current portion | 24,587 | 25,591 | ||||
Other liabilities | 407 | 474 | ||||
Total long-term liabilities | 133,272 | 67,546 | ||||
Total liabilities | $ | 181,952 | $ | 188,586 | ||
Series A preferred shares, no par value; 3,901,348 shares issued and outstanding at March 31, 2021 and December 31, 2020 |
$ | 7,874 | $ | 7,874 | ||
Shareholders’ equity: | ||||||
Ordinary shares, no par value; 49,854,651 and 48,778,678 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively |
$ | 702,649 | $ | 694,085 | ||
Additional paid-in capital | 75,636 | 71,573 | ||||
Accumulated other comprehensive income | 269 | 389 | ||||
Accumulated deficit | (725,733 | ) | (683,269 | ) | ||
Total shareholders’ equity | $ | 52,821 | $ | 82,778 | ||
Total liabilities, Series A preferred shares and shareholders’ equity | $ | 242,647 | $ | 279,238 |
WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
Three Months Ended March 31, | ||||||
2021 | 2020 | |||||
Revenue | $ | — | $ | 4,161 | ||
Operating expenses: | ||||||
Research and development | 33,393 | 41,158 | ||||
General and administrative | 10,078 | 12,996 | ||||
Total operating expenses | 43,471 | 54,154 | ||||
Loss from operations | (43,471 | ) | (49,993 | ) | ||
Other income, net: | ||||||
Dividend income and interest income, net | 11 | 388 | ||||
Other income, net | 996 | 2,112 | ||||
Total other income, net | 1,007 | 2,500 | ||||
Loss before income taxes | (42,464 | ) | (47,493 | ) | ||
Income tax provision | — | — | ||||
Net loss | $ | (42,464 | ) | $ | (47,493 | ) |
Net loss per share attributable to ordinary shareholders—basic and diluted |
$ | (0.86 | ) | $ | (1.38 | ) |
Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders—basic and diluted |
49,101,606 | 34,461,505 | ||||
Other comprehensive income (loss): | ||||||
Net loss | $ | (42,464 | ) | $ | (47,493 | ) |
Foreign currency translation | (120 | ) | 6 | |||
Comprehensive loss | $ | (42,584 | ) | $ | (47,487 | ) |
Investor Contact:
Kate Rausch
617-949-4827
krausch@wavelifesci.com
Media Contact:
Alicia Suter
617-949-4817
asuter@wavelifesci.com
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