Full Press Release Details
WAVE Life Sciences Reports First Quarter 2016 Financial Results and Provides Business Update
On track to deliver six clinical programs by 2018, including two IND filings in 2016
Entered collaboration with Pfizer to develop genetically targeted therapies for the treatment of metabolic diseases
Existing cash supports pipeline progression, clinical programs and operations into 2019
CAMBRIDGE, Mass. May 16, 2016 WAVE Life Sciences Ltd. (NASDAQ: WVE), a genetic medicines company focused on developing stereopure nucleic acid
therapies for patients impacted by rare diseases, today reported financial results for the first quarter ended March 31, 2016 and provided a business update.
Building on our tremendous momentum from 2015, we have achieved a series of key milestones that have positioned us for continued growth in 2016 and
beyond, said Paul Bolno, M.D., MBA, President and Chief Executive Officer of WAVE Life Sciences. In January, we announced a clear strategic plan for our future, focused on developing a portfolio of medicines for patients with
neurological and neuromuscular diseases while leveraging the versatility of our platform to work alongside partners who have deep expertise in other therapeutic areas. In this first quarter, we commenced IND-enabling studies for our HD HTT SNP-1
program and selected lead candidates for our HD HTT SNP-2 program and our exon 51 DMD program. In addition, we entered into a collaboration with Pfizer validating our externalization strategy.
Pipeline Update and Outlook
First Quarter 2016 Financial Results and Financial Guidance
WAVE reported a net loss of $7.8 million in the first quarter of 2016 as compared to a net loss of $3.5 million in the first quarter of 2015. The increase in
net loss for the first quarter was largely due to increased research and development efforts as well as investments in the company s infrastructure as a publicly traded company.
Research and development expenses were $4.7 million for the first quarter of 2016 as compared to $1.6 million for the same period in 2015. The increase in
research and development expenses in the quarter was primarily driven by increased spending on third party-related costs used to advance WAVE s preclinical and drug discovery activities, as well as increased salary and related benefits costs
due to the increase in employee headcount.
General and administrative expenses were $3.2 million for the first quarter of 2016 as compared to $1.9
million for the same period in the prior year. The increase in general and administrative expenses in the first quarter was primarily due to an increase in professional fees and outside support services due to the costs of being a public company, as
well as salary and benefits increases due to an increase in headcount.
WAVE s cash as of March 31, 2016 was $153.4 million compared to $161.2
million as of December 31, 2015. The decrease in cash was primarily the result of our net loss for the first quarter of 2016.
WAVE expects that the
cash resources it had on hand at March 31, 2016, together with the $40.0 million in upfront cash payments under the May 2016 Pfizer collaboration, will fund its operating expenses and capital expenditure requirements into 2019.
About WAVE Life Sciences
At WAVE Life Sciences, we are driven by an unwavering passion and commitment to deliver on our mission of confronting challenging diseases by developing
transformational therapies and empowering patients. We are utilizing our innovative and proprietary synthetic chemistry drug development platform to design, develop and commercialize stereopure nucleic acid therapeutics that precisely target the
underlying cause of rare and other serious genetically defined diseases. Given the versatility of our chemistry platform, WAVE s deep, diverse pipeline spans multiple modalities including antisense, exon-skipping, and single-stranded
Forward Looking Information
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: our filing of INDs and
commencing clinical trials; the future performance and results of our programs in clinical trials; our identification of future candidates and their therapeutic potential; the anticipated therapeutic benefits of stereopure therapies compared to
other therapies; our advancing of therapies across multiple modalities and the anticipated benefits of that strategy; our future growth; the potential of our stereopure approach and nucleic acid therapeutics; and our cash position supporting our
anticipated business activities. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the following: the ability of our preclinical programs to produce data
sufficient to support the filing of INDs 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 stereopure candidates in clinical trials, including our ability to
develop candidates across multiple therapeutic modalities; 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; our ability to raise additional capital as needed; and competition from others developing therapies for similar uses, as well as the information under the caption Risk Factors contained in our Annual Report on Form 10-K filed
with the Securities and Exchange Commission (SEC) on March 30, 2016 and in other filings we make with the SEC. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or
Chris Brinzey, 339-970-2843
Feinstein Kean Healthcare
Jess Rowlands, 202-729-4089
WAVE LIFE SCIENCES LTD.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
| March 31, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 153,397 | $ | 161,220 | ||||
| Prepaid expenses and other current assets | 580 | 146 | ||||||
| Deferred tax assets | 23 | 18 | ||||||
| Total current assets | 154,000 | 161,384 | ||||||
| Property and equipment, net | 3,218 | 2,789 | ||||||
| Deferred tax assets | 192 | 192 | ||||||
| Restricted cash | 1,055 | 1,055 | ||||||
| Other assets | 57 | 4 | ||||||
| Total assets | $ | 158,522 | $ | 165,424 | ||||
| Liabilities, Series A preferred shares and shareholders equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,437 | $ | 2,811 | ||||
| Accrued expenses and other current liabilities | 1,271 | 945 | ||||||
| Current portion of capital lease obligation | 62 | 62 | ||||||
| Total current liabilities | 3,770 | 3,818 | ||||||
| Long-term liabilities: | ||||||||
| Capital lease obligation, net of current portion | 62 | 78 | ||||||
| Other liabilities | 295 | 163 | ||||||
| Total long-term liabilities | 357 | 241 | ||||||
| Total liabilities | $ | 4,127 | $ | 4,059 | ||||
| Series A preferred shares, no par value; 3,901,348 shares issued and outstanding | 7,874 | 7,874 | ||||||
| Shareholders equity: | ||||||||
| Ordinary shares, no par value; 21,551,423 shares issued and outstanding | 185,344 | 185,344 | ||||||
| Additional paid-in capital | 4,048 | 3,182 | ||||||
| Accumulated other comprehensive income | 52 | 41 | ||||||
| Accumulated deficit | (42,923 | ) | (35,076 | ) | ||||
| Total shareholders equity | 146,521 | 153,491 | ||||||
| Total liabilities, Series A preferred shares and shareholders equity | $ | 158,522 | $ | 165,424 |
WAVE LIFE SCIENCES LTD.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenue | $ | $ | 26 | |||||
| Operating expenses: | ||||||||
| Research and development | 4,736 | 1,607 | ||||||
| General and administrative | 3,216 | 1,884 | ||||||
| Total operating expenses | 7,952 | 3,491 | ||||||
| Loss from operations | (7,952 | ) | (3,465 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 104 | |||||||
| Other income (expense), net | (4 | ) | 50 | |||||
| Total other income (expense), net | 100 | 50 | ||||||
| Loss before income tax provision | (7,852 | ) | (3,415 | ) | ||||
| Income tax benefit (provision) | 5 | (50 | ) | |||||
| Net loss | $ | (7,847 | ) | $ | (3,465 | ) | ||
| Net loss per share attributable to ordinary shareholders basic and diluted | $ | (0.36 | ) | $ | (0.42 | ) | ||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders basic and diluted | 21,551,423 | 8,273,805 |
WAVE LIFE SCIENCES LTD.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Net loss | $ | (7,847 | ) | $ | (3,465 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Foreign currency translation | 11 | (28 | ) | |||||
| Comprehensive loss | $ | (7,836 | ) | $ | (3,493 | ) |