Full Press Release Details
Wave Life Sciences Reports First Quarter 2023 Financial Results and Provides Business Update
Emerging leader in RNA medicines with multi-modal discovery and development platform and first-in-class RNA editing
Rapidly advancing toward 2023 CTA submissions and
first-in-human study for WVE-006, the industry s first RNA editing
Planning for potentially registrational Phase 2 clinical study for WVE-N531 to assess functional
restoration in DMD patients, following
best-in-class exon-skipping data reported in December 2022
Preparing broad suite of first- and best-in-class medicines
enabled by multi-modal RNA medicine platform and
proprietary genetic insights from GSK collaboration; investor event anticipated in
Cash and cash equivalents of $207.6 million as of March 31, 2023, with runway expected into 2025, plus potential
milestone payments from GSK collaboration in 2023 and beyond
Investor conference call and webcast at 8:30 a.m. ET today
CAMBRIDGE, Mass., May 3, 2023 Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage RNA medicines company committed to
delivering life-changing treatments for people battling devastating diseases, today announced financial results for the first quarter ended March 31, 2023 and provided a business update.
The first quarter of 2023 was marked by the launch of our transformational collaboration with GSK, which we believe will allow us to build substantial
patient and shareholder value by expanding and accelerating our pipeline with capital, clinical capability, and proprietary genetic insights. This collaboration, which provided $170 million in upfront cash and equity, has the potential to
provide additional cash milestones in 2023 and beyond. We are expeditiously progressing the industry s first RNA editing candidate, WVE-006, toward CTA submissions for
alpha-1 antitrypsin deficiency, with the goal of early clinical proof-of-concept via measurement of validated serum surrogate
markers in a clinical trial. In the first quarter, we also prepared for the launch of a potentially registrational Phase 2 study of WVE-N531 for boys with DMD, which is a program we believe may provide an
important therapeutic option for them, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. We are well-capitalized through our existing cash and potential near-term milestones to deliver on a steady
cadence of clinical data across 2023 and 2024. Additionally, using our clinically validated multi-modal RNA medicines platform, we are preparing the next set of development programs that leverage our unique RNA editing, splicing, and knockdown
capabilities. In the third quarter of this year, we plan to hold an investor event, during which we will demonstrate how we are continuing to extend our leadership in RNA editing and share preclinical data on new programs.
Recent Business Highlights
Recent Scientific Publications
Anticipated Upcoming Milestones and Events
WVE-004 for ALS/FTD:
Platform and Pipeline:
First Quarter 2023 Financial Results
Wave reported a net loss of $27.4 million in the first quarter of 2023, as compared to $37.8 million in the same period in 2022. The decrease in net
loss year-over-year was primarily driven by revenue earned under the company s collaboration with GSK, which became effective January 27, 2023. Revenue earned under the GSK and Takeda collaborations in the first quarter of 2023 was
$12.9 million. During the first quarter of 2022, revenue of $1.8 million was primarily earned under the Takeda collaboration.
development expenses were $31.0 million in the first quarter of 2023, as compared to $27.5 million in the same period in 2022. The increase in research and development expenses was primarily due to increased external expenses related to
Wave s clinical programs, as well as compensation-related expenses driven by growth to support the company s programs.
administrative expenses were $12.2 million in the first quarter of 2023, as compared to $12.4 million in the same period in 2022, primarily due to a decrease in compensation-related expenses.
As of March 31, 2023, Wave had $207.6 million in cash and cash equivalents, as compared to $88.5 million as of December 31, 2022. The
company expects that its current cash and cash equivalents will be sufficient to fund operations into 2025.
Investor Conference Call and Webcast
Wave will host an investor conference call today at 8:30 a.m. ET to review first quarter 2023 financial results and pipeline updates. A
webcast of the conference call can be accessed by visiting Investor Events on the investor relations section of the Wave Life Sciences website:
https://ir.wavelifesciences.com/events-and-presentations. Analysts planning to participate during the Q&A portion of the live call can join the conference
call at the following audio conferencing link: available here. Once registered, participants will receive the dial-in information. Following the live event, an archived version of the webcast will
be available on the Wave Life Sciences website.
About Wave Life Sciences
Wave Life Sciences (Nasdaq: WVE) is a clinical-stage RNA 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 initiation, site activation, patient recruitment, patient enrollment, dosing, generation of data and completion of our
clinical trials, and the announcement of such events; the protocol, design and endpoints of our 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; the potential achievement of milestones under our collaborations and receipt of cash payments therefor; the potential of our preclinical data to predict the behavior of our
compounds in humans; our identification and expected timing of future product candidates and their therapeutic potential; the anticipated benefits of our therapeutic candidates compared to others; our ability to design compounds using multiple
modalities and the anticipated benefits of that approach; the breadth and versatility of PRISM; the expected benefits of our stereopure oligonucleotides compared with stereorandom oligonucleotides; the potential benefits of our RNA editing
capability, including our AIMers, compared to others; the status and progress of our programs relative to potential competitors; anticipated benefits of our proprietary manufacturing processes and our internal manufacturing capabilities; the benefit
of nucleic acid therapeutics generally; the strength of our intellectual property and the data that support our IP; the anticipated duration of our cash runway; our intended uses of capital; and our expectations regarding any potential global macro
events beyond our control 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; the clinical results of our programs and the
timing thereof, which may not support further development of our product candidates; actions of regulatory authorities and their receptiveness to our adaptive trial designs, which may affect the initiation, timing and progress of clinical trials;
our effectiveness in managing regulatory interactions and future clinical trials; the effectiveness of PRISM; the effectiveness of our RNA editing capability and our AIMers; 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 the indications we are pursuing; our ability to maintain the company infrastructure and personnel needed to achieve our goals; and
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, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 207,562 | $ | 88,497 | ||||
| Prepaid expenses | 9,231 | 7,932 | ||||||
| Other current assets | 2,798 | 2,108 | ||||||
| Total current assets | 219,591 | 98,537 | ||||||
| Long-term assets: | ||||||||
| Property and equipment, net of accumulated depreciation of $39,197 and $37,846 as of March 31, 2023 and December 31, 2022, respectively | 16,005 | 17,284 | ||||||
| Operating lease right-of-use assets | 25,838 | 26,843 | ||||||
| Restricted cash | 4,660 | 3,660 | ||||||
| Other assets | 1,176 | 62 | ||||||
| Total long-term assets | 47,679 | 47,849 | ||||||
| Total assets | $ | 267,270 | $ | 146,386 | ||||
| Liabilities, Series A preferred shares and shareholders equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,906 | $ | 16,915 | ||||
| Accrued expenses and other current liabilities | 7,622 | 17,552 | ||||||
| Current portion of deferred revenue | 106,960 | 31,558 | ||||||
| Current portion of operating lease liability | 6,078 | 5,496 | ||||||
| Total current liabilities | 132,566 | 71,521 | ||||||
| Long-term liabilities: | ||||||||
| Deferred revenue, net of current portion | 130,820 | 79,774 | ||||||
| Operating lease liability, net of current portion | 30,534 | 32,118 | ||||||
| Other liabilities | 190 | 190 | ||||||
| Total long-term liabilities | 161,544 | 112,082 | ||||||
| Total liabilities | $ | 294,110 | $ | 183,603 | ||||
| Series A preferred shares, no par value; 3,901,348 shares issued and outstanding at March 31, 2023 and December 31, 2022 | $ | 7,874 | $ | 7,874 | ||||
| Shareholders equity (deficit): | ||||||||
| Ordinary shares, no par value; 98,104,844 and 86,924,643 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | $ | 837,886 | $ | 802,833 | ||||
| Additional paid-in capital | 122,192 | 119,442 | ||||||
| Accumulated other comprehensive income (loss) | (50 | ) | (29 | ) | ||||
| Accumulated deficit | (994,742 | ) | (967,337 | ) | ||||
| Total shareholders equity (deficit) | $ | (34,714 | ) | $ | (45,091 | ) | ||
| Total liabilities, Series A preferred shares and shareholders equity (deficit) | $ | 267,270 | $ | 146,386 |
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, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 12,929 | $ | 1,750 | ||||
| Operating expenses: | ||||||||
| Research and development | 30,979 | 27,470 | ||||||
| General and administrative | 12,235 | 12,374 | ||||||
| Total operating expenses | 43,214 | 39,844 | ||||||
| Loss from operations | (30,285 | ) | (38,094 | ) | ||||
| Other income, net: | ||||||||
| Dividend income and interest income, net | 1,873 | 26 | ||||||
| Other income, net | 1,007 | 254 | ||||||
| Total other income, net | 2,880 | 280 | ||||||
| Loss before income taxes | (27,405 | ) | (37,814 | ) | ||||
| Income tax provision | ||||||||
| Net loss | $ | (27,405 | ) | $ | (37,814 | ) | ||
| Net loss per share attributable to ordinary shareholders basic and diluted | $ | (0.27 | ) | $ | (0.62 | ) | ||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders basic and diluted | 102,056,712 | 60,516,616 | ||||||
| Other comprehensive loss: | ||||||||
| Net loss | $ | (27,405 | ) | $ | (37,814 | ) | ||
| Foreign currency translation | (21 | ) | (86 | ) | ||||
| Comprehensive loss | $ | (27,426 | ) | $ | (37,900 | ) |