Full Press Release Details
WAVE Life Sciences Reports Second Quarter 2016 Financial Results and Provides Business Update
On track to file two INDs for lead programs in Huntington s disease in 2016 and IND for lead program in Duchenne muscular dystrophy in
Current financial position supports continued pipeline progression, six clinical programs by 2018 and operations into 2019
CAMBRIDGE, Mass. (BUSINESS WIRE) August 15, 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 second quarter ended June 30, 2016 and provided a business update.
We are continuing to build on the substantial progress made at the start of 2016 and have the science, portfolio of programs, talent and financial
runway to achieve our previously stated goals, said Paul Bolno, M.D., MBA, President and Chief Executive Officer of WAVE Life Sciences. We are continuing to grow as a company, hiring talented and passionate individuals who are committed
to delivering exceptional therapies for patients. In July, we appointed Dr. Michael Panzara as the Head of our Neurology Franchise to accelerate the progress of our neurology portfolio, starting with our two lead programs in Huntington s
disease and Duchenne muscular dystrophy. We have presented promising data on the potential of our exon 51 candidate for DMD, and have received Orphan Drug Designation for our first lead candidate in Huntington s disease, placing us in a strong
position to advance these candidates into the clinic.
Pipeline Update and Outlook
Second Quarter 2016 Financial Results and Financial Guidance
WAVE reported a net loss of $11.6 million in the second quarter of 2016 as compared to a net loss of $3.7 million in the second quarter of
2015. The increase in net loss for the second 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 $8.4 million for the second quarter of 2016 as compared to $1.9 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 $3.7 million for the second 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 second 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 June 30,
2016 was $181.8 million compared to $153.4 million as of March 31, 2016. The increase in cash was primarily related to the upfront payment received upon commencement of the collaboration with Pfizer.
Net cash used in operating activities was $6.7 million for the six months ended June 30, 2016 as compared to $3.0 million for the
same period in the prior year. WAVE expects that the cash resources it had on hand at June 30, 2016 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 RNAi. For
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 circumstances.
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)
| June 30, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 181,765 | $ | 161,220 | ||||
| Prepaid expenses and other current assets | 2,176 | 146 | ||||||
| Deferred tax assets | 18 | |||||||
| Total current assets | 183,941 | 161,384 | ||||||
| Property and equipment, net | 5,093 | 2,789 | ||||||
| Deferred tax assets | 192 | 192 | ||||||
| Restricted cash | 1,055 | 1,055 | ||||||
| Other assets | 57 | 4 | ||||||
| Total assets | $ | 190,338 | $ | 165,424 | ||||
| Liabilities, Series A preferred shares and shareholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,899 | $ | 2,811 | ||||
| Accrued expenses and other current liabilities | 2,161 | 945 | ||||||
| Current portion of capital lease obligation | 62 | 62 | ||||||
| Deferred tax liabilities | 25 | |||||||
| Current portion of deferred revenue | 2,500 | |||||||
| Total current liabilities | 8,647 | 3,818 | ||||||
| Long-term liabilities: | ||||||||
| Capital lease obligation, net of current portion | 47 | 78 | ||||||
| Deferred revenue, net of current portion | 7,083 | |||||||
| Other liabilities | 409 | 163 | ||||||
| Total long-term liabilities | 7,539 | 241 | ||||||
| Total liabilities | $ | 16,186 | $ | 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; 23,432,923 and 21,551,423 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 215,372 | 185,344 | ||||||
| Additional paid-in capital | 5,318 | 3,182 | ||||||
| Accumulated other comprehensive income | 76 | 41 | ||||||
| Accumulated deficit | (54,488 | ) | (35,076 | ) | ||||
| Total shareholders equity | 166,278 | 153,491 | ||||||
| Total liabilities, Series A preferred shares and shareholders equity | $ | 190,338 | $ | 165,424 |
WAVE LIFE SCIENCES LTD.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenue | $ | 417 | $ | 126 | $ | 417 | $ | 152 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,401 | 1,850 | 13,137 | 3,457 | ||||||||||||
| General and administrative | 3,654 | 1,905 | 6,870 | 3,789 | ||||||||||||
| Total operating expenses | 12,055 | 3,755 | 20,007 | 7,246 | ||||||||||||
| Loss from operations | (11,638 | ) | (3,629 | ) | (19,590 | ) | (7,094 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | 106 | (15 | ) | 211 | (15 | ) | ||||||||||
| Other income (expense), net | 15 | (7 | ) | 10 | 43 | |||||||||||
| Total other income (expense), net | 121 | (22 | ) | 221 | 28 | |||||||||||
| Loss before income tax provision | (11,517 | ) | (3,651 | ) | (19,369 | ) | (7,066 | ) | ||||||||
| Income tax provision | (48 | ) | (49 | ) | (43 | ) | (99 | ) | ||||||||
| Net loss | $ | (11,565 | ) | $ | (3,700 | ) | $ | (19,412 | ) | $ | (7,165 | ) | ||||
| Net loss per share attributable to ordinary shareholders basic and diluted | $ | (0.51 | ) | $ | (0.40 | ) | $ | (0.88 | ) | $ | (0.82 | ) | ||||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders basic and diluted | 22,708,022 | 9,223,405 | 22,126,562 | 8,729,072 |