Full Press Release Details
Wave Life Sciences Reports Third Quarter 2023 Financial Results and Provides Business Update
Initiated RestorAATion clinical program for WVE-006, industry s first-ever RNA editing clinical
candidate, following approval of CTAs; dosing on track for 4Q 2023 and first-in-human
proof-of-mechanism data anticipated in 2024
track to deliver dystrophin data from potentially registrational FORWARD-53 trial of WVE-N531 in 2024
Enrollment complete in 30 mg multi-dose cohort of SELECT-HD with clinical data for decision-making
on track for 2Q 2024; achieved milestone from Takeda collaboration for NHP study that further reinforces productive distribution of WVE-003 to deep brain regions
Presented preclinical proof-of-concept data for new, wholly
owned GalNAc-siRNA INHBE program for metabolic disorders, including obesity; leads identified and clinical candidate selection expected in 4Q 2024
Cash and cash equivalents of $140 million as of September 30, 2023, plus $7 million milestone payment from Takeda
collaboration received in 4Q, with runway expected into 2025; additional potential near-term milestone payments from GSK collaboration in 2023 and beyond
Investor conference call and webcast at 8:30 a.m. ET today
CAMBRIDGE, Mass., November 9, 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 third quarter ended September 30, 2023, and provided a business update.
The team has made tremendous progress during the past quarter as we solidified our leadership in RNA editing through the initiation of our clinical
trial evaluating the first-ever RNA editing therapeutic, WVE-006. Additionally this quarter, we advanced our WVE-N531 (DMD) and
WVE-003 (HD) clinical development programs and expanded our RNA therapeutic capabilities beyond rare diseases to common diseases with the announcement of our first GalNAc-conjugated siRNA program targeting
INHBE to treat metabolic disorders, including obesity, said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. As we shared during our recent R&D Day, we will sustain our leadership in RNA editing by
building a pipeline of wholly owned editing candidates, each of which will have efficient paths to clinical proof-of-concept and represent significant commercial
opportunities. With multiple, high impact clinical data readouts expected over the course of 2024 and plans to expeditiously deliver on a growing pipeline of RNA-targeting modalities, Wave is truly at an
exciting inflection point.
Recent Business Highlights
Anticipated Upcoming Milestones
INHBE program for metabolic disorders, including obesity
Platform and Pipeline:
Third Quarter 2023 Financial Results
Wave reported a net income of $7.3 million in the third quarter of 2023, as compared to a net loss of $39.0 million in the same period in 2022. The
year-over-year change was primarily driven by the $48.9 million increase in revenue recognized under its collaborations. Under the Takeda collaboration, Wave earned $7.0 million dollars for the achievement of a WVE-003 non-clinical milestone. Additionally, under the Takeda collaboration, Wave recognized $28.0 million relating to the discontinuation of WVE-004 and under the GSK Collaboration, recognized $14.3 million.
Research and development expenses were
$31.6 million in the third quarter of 2023, as compared to $27.6 million in the same period in 2022. The increase in research and development expenses was primarily driven by increased external expenses related to all three of Wave s
General and administrative expenses were $13.1 million in the third quarter of 2023, as compared to
$11.6 million in the same period in 2022. The increase was primarily due to increased professional and consulting expenses as well as other general expenses.
As of September 30, 2023, Wave had $139.9 million in cash and cash equivalents, as compared to $88.5 million as of December 31, 2022.
Subsequent to the quarter end, Wave received the $7.0 million for the achievement of the previously discussed milestone. 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 third 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
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 X (formerly Twitter)
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, including any potential registration based on these data, 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 potential benefits of our GalNAc-conjugated siRNA program targeting INHBE, the potential benefits that our edit-verse map may offer to
identify new RNA editing targets; 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)
| September 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 139,942 | $ | 88,497 | ||||
| Accounts receivable | 7,000 | |||||||
| Prepaid expenses | 7,514 | 7,932 | ||||||
| Other current assets | 4,116 | 2,108 | ||||||
| Total current assets | 158,572 | 98,537 | ||||||
| Long-term assets: | ||||||||
| Property and equipment, net of accumulated depreciation of $41,596 and $37,846 as of September 30, 2023 and December 31, 2022, respectively | 13,770 | 17,284 | ||||||
| Operating lease right-of-use assets | 23,738 | 26,843 | ||||||
| Restricted cash | 3,683 | 3,660 | ||||||
| Other assets | 155 | 62 | ||||||
| Total long-term assets | 41,346 | 47,849 | ||||||
| Total assets | $ | 199,918 | $ | 146,386 | ||||
| Liabilities, Series A preferred shares and shareholders equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,608 | $ | 16,915 | ||||
| Accrued expenses and other current liabilities | 12,624 | 17,552 | ||||||
| Current portion of deferred revenue | 68,251 | 31,558 | ||||||
| Current portion of operating lease liability | 6,497 | 5,496 | ||||||
| Total current liabilities | 99,980 | 71,521 | ||||||
| Long-term liabilities: | ||||||||
| Deferred revenue, net of current portion | 105,380 | 79,774 | ||||||
| Operating lease liability, net of current portion | 27,170 | 32,118 | ||||||
| Other liabilities | 190 | |||||||
| Total long-term liabilities | 132,550 | 112,082 | ||||||
| Total liabilities | $ | 232,530 | $ | 183,603 | ||||
| Series A preferred shares, no par value; 3,901,348 shares issued and outstanding at September 30, 2023 and December 31, 2022 | $ | 7,874 | $ | 7,874 | ||||
| Shareholders equity (deficit): | ||||||||
| Ordinary shares, no par value; 99,011,901 and 86,924,643 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | $ | 841,405 | $ | 802,833 | ||||
| Additional paid-in capital | 126,885 | 119,442 | ||||||
| Accumulated other comprehensive loss | (182 | ) | (29 | ) | ||||
| Accumulated deficit | (1,008,594 | ) | (967,337 | ) | ||||
| Total shareholders deficit | $ | (40,486 | ) | $ | (45,091 | ) | ||
| Total liabilities, Series A preferred shares and shareholders deficit | $ | 199,918 | $ | 146,386 |
WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | 49,214 | $ | 285 | $ | 84,249 | $ | 2,410 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 31,642 | 27,575 | 95,935 | 84,778 | ||||||||||||
| General and administrative | 13,128 | 11,609 | 37,628 | 36,789 | ||||||||||||
| Total operating expenses | 44,770 | 39,184 | 133,563 | 121,567 | ||||||||||||
| Income (loss) from operations | 4,444 | (38,899 | ) | (49,314 | ) | (119,157 | ) | |||||||||
| Other income (expense), net: | ||||||||||||||||
| Dividend income and interest income, net | 1,960 | 596 | 6,084 | 746 | ||||||||||||
| Other income (expense), net | 171 | (701 | ) | 1,296 | 297 | |||||||||||
| Total other income (expense), net | 2,131 | (105 | ) | 7,380 | 1,043 | |||||||||||
| Income (loss) before income taxes | 6,575 | (39,004 | ) | (41,934 | ) | (118,114 | ) | |||||||||
| Income tax benefit (provision) | 677 | 677 | ||||||||||||||
| Net income (loss) | $ | 7,252 | $ | (39,004 | ) | $ | (41,257 | ) | $ | (118,114 | ) | |||||
| Less: net income attributable to participating securities | $ | (257 | ) | |||||||||||||
| Net income (loss) attributable to ordinary shareholders, basic and diluted | $ | 6,995 | $ | (39,004 | ) | $ | (41,257 | ) | $ | (118,114 | ) | |||||
| Net income (loss) per share attributable to ordinary shareholders basic | $ | 0.07 | $ | (0.42 | ) | $ | (0.39 | ) | $ | (1.60 | ) | |||||
| Weighted-average ordinary shares used in computing net income (loss) per share attributable to ordinary shareholders basic | 106,025,063 | 93,900,484 | 104,529,266 | 73,754,417 | ||||||||||||
| Net income (loss) per share attributable to ordinary shareholders diluted | $ | 0.07 | $ | (0.42 | ) | $ | (0.39 | ) | $ | (1.60 | ) | |||||
| Weighted-average ordinary shares used in computing net income (loss) per share attributable to ordinary shareholders diluted | 106,975,231 | 93,900,484 | 104,529,266 | 73,754,417 | ||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Net income (loss) | $ | 7,252 | $ | (39,004 | ) | $ | (41,257 | ) | $ | (118,114 | ) | |||||
| Foreign currency translation | (32 | ) | (76 | ) | (153 | ) | (304 | ) | ||||||||
| Comprehensive income (loss) | $ | 7,220 | $ | (39,080 | ) | $ | (41,410 | ) | $ | (118,418 | ) |