CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2023, and provided a business update.
“In the second quarter, we continued to rapidly advance our pipeline of RNA medicines towards meaningful inflection points. We are on the cusp of moving the industry’s first RNA editing therapeutic candidate, WVE-006 for alpha-1 antitrypsin deficiency or AATD, into the clinic, which will mark an important milestone not only for Wave, but also for individuals living with AATD and the entire RNA medicines field. WVE-006 has the potential to transform the standard of care for people living with AATD, and the goal of our initial clinical trial will be delivering early clinical proof-of-concept via measurement of validated serum surrogate markers,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “While we were disappointed to discontinue WVE-004 for C9-ALS and FTD in the second quarter, we did see successful translation of our preclinical pharmacodynamic effects to clinical biomarker effects, including robust, sustained reductions of up to 50% in poly(GP) with multiple doses. These results are also important validation of our PN chemistry, which is encouraging for our current and upcoming clinical programs, including in DMD, HD, and AATD.”
Dr. Bolno continued: “Momentum is building rapidly in our collaboration with GSK, which kicked off at the start of this year, and we are actively working on multiple targets while leveraging proprietary genetic insights through the collaboration. We are excited to share new data on RNA editing disease targets at our annual ‘R&D Day’ virtual event in September. Wave is well-capitalized to leverage our unique, multimodal platform to develop novel RNA medicines and deliver on a steady cadence of clinical data through 2024 and beyond.”
Recent Business Highlights
Anticipated Upcoming Milestones and Events
WVE-N531 for DMD:
WVE-006 for AATD:
WVE-003 for HD:
Platform and Pipeline:
Second Quarter 2023 Financial Results
Wave reported a net loss of $21.1 million in the second quarter of 2023, as compared to $41.3 million in the same period in 2022. The decrease in net loss year-over-year was primarily driven by revenue recognized under the company’s collaboration with GSK, which became effective January 27, 2023. Revenue recognized under the GSK and Takeda collaborations in the second quarter of 2023 was $22.1 million. During the second quarter of 2022, revenue of $0.4 million was recognized under the Takeda collaboration.
Research and development expenses were $33.3 million in the second quarter of 2023, as compared to $29.7 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.
General and administrative expenses were $12.3 million in the second quarter of 2023, as compared to $12.8 million in the same period in 2022, primarily due to a decrease in share-based compensation.
As of June 30, 2023, Wave had $173.0 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 second 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) | ||||||||
| June 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 172,974 | $ | 88,497 | ||||
| Prepaid expenses | 9,012 | 7,932 | ||||||
| Other current assets | 2,722 | 2,108 | ||||||
| Total current assets | 184,708 | 98,537 | ||||||
| Long-term assets: | ||||||||
| Property and equipment, net of accumulated depreciation of $40,423 and $37,846 as of June 30, 2023, and December 31, 2022, respectively | 14,983 | 17,284 | ||||||
| Operating lease right-of-use assets | 24,805 | 26,843 | ||||||
| Restricted cash | 3,668 | 3,660 | ||||||
| Other assets | 1,821 | 62 | ||||||
| Total long-term assets | 45,277 | 47,849 | ||||||
| Total assets | $ | 229,985 | $ | 146,386 | ||||
| Liabilities, Series A preferred shares and shareholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,379 | $ | 16,915 | ||||
| Accrued expenses and other current liabilities | 10,429 | 17,552 | ||||||
| Current portion of deferred revenue | 111,133 | 31,558 | ||||||
| Current portion of operating lease liability | 6,285 | 5,496 | ||||||
| Total current liabilities | 140,226 | 71,521 | ||||||
| Long-term liabilities: | ||||||||
| Deferred revenue, net of current portion | 104,540 | 79,774 | ||||||
| Operating lease liability, net of current portion | 28,875 | 32,118 | ||||||
| Other liabilities | 190 | 190 | ||||||
| Total long-term liabilities | 133,605 | 112,082 | ||||||
| Total liabilities | $ | 273,831 | $ | 183,603 | ||||
| Series A preferred shares, no par value; 3,901,348 shares issued and outstanding at June 30, 2023, and December 31, 2022 | $ | 7,874 | $ | 7,874 | ||||
| Shareholders’ equity (deficit): | ||||||||
| Ordinary shares, no par value; 98,566,816 and 86,924,643 shares issued and outstanding at June 30, 2023, and December 31, 2022, respectively | $ | 839,675 | $ | 802,833 | ||||
| Additional paid-in capital | 124,601 | 119,442 | ||||||
| Accumulated other comprehensive income (loss) | (150 | ) | (29 | ) | ||||
| Accumulated deficit | (1,015,846 | ) | (967,337 | ) | ||||
| Total shareholders’ equity (deficit) | $ | (51,720 | ) | $ | (45,091 | ) | ||
| Total liabilities, Series A preferred shares and shareholders’ equity (deficit) | $ | 229,985 | $ | 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | 22,106 | $ | 375 | $ | 35,035 | $ | 2,125 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 33,314 | 29,733 | 64,293 | 57,203 | ||||||||||||
| General and administrative | 12,265 | 12,806 | 24,500 | 25,180 | ||||||||||||
| Total operating expenses | 45,579 | 42,539 | 88,793 | 82,383 | ||||||||||||
| Loss from operations | (23,473 | ) | (42,164 | ) | (53,758 | ) | (80,258 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Dividend income and interest income, net | 2,251 | 124 | 4,124 | 150 | ||||||||||||
| Other income, net | 118 | 744 | 1,125 | 998 | ||||||||||||
| Total other income, net | 2,369 | 868 | 5,249 | 1,148 | ||||||||||||
| Loss before income taxes | (21,104 | ) | (41,296 | ) | (48,509 | ) | (79,110 | ) | ||||||||
| Income tax provision | — | — | — | — | ||||||||||||
| Net loss | $ | (21,104 | ) | $ | (41,296 | ) | $ | (48,509 | ) | $ | (79,110 | ) | ||||
| Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.20 | ) | $ | (0.62 | ) | $ | (0.47 | ) | $ | (1.25 | ) | ||||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders—basic and diluted | 105,462,414 | 66,479,293 | 103,768,971 | 63,514,426 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | $ | (21,104 | ) | $ | (41,296 | ) | $ | (48,509 | ) | $ | (79,110 | ) | ||||
| Foreign currency translation | (100 | ) | (142 | ) | (121 | ) | (228 | ) | ||||||||
| Comprehensive loss | $ | (21,204 | ) | $ | (41,438 | ) | $ | (48,630 | ) | $ | (79,338 | ) | ||||
Investor Contact:
Kate Rausch
+1 617-949-4827
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Media Contact:
Alicia Suter
+1 617-949-4817
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| Last Trade: | US$14.89 |
| Daily Change: | 0.62 4.34 |
| Daily Volume: | 1,668,415 |
| Market Cap: | US$1.860B |
November 12, 2024 October 30, 2024 October 16, 2024 | |
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