CAMBRIDGE, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
“With our recent positive SELECT-HD trial results, we have further validated our chemistry and the clinical translation of our platform. Today, we have built an RNA medicines platform that is positioned to sustainably translate clinical genetic insights into transformational medicines as we continue to advance our lead programs through multiple important milestones in the second half of this year,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “Clinical results from our SELECT-HD trial in HD demonstrated statistically significant, potent, and durable allele-selective silencing with WVE-003, and we are working rapidly to engage regulators on a potential path to accelerated approval. These data have also bolstered our confidence ahead of expected upcoming readouts from our potentially registrational FORWARD-53 trial in DMD and our RestorAATion-2 trial in AATD. In parallel with these efforts, we continue to drive our best-in-class obesity candidate, WVE-007, toward the clinic and are on track to initiate the first-in-human study in the first quarter of next year. We look forward to providing additional updates on our growing, high-value pipeline and our progress towards reimagining what’s possible for human health at our R&D Day this Fall.”
Recent Business Highlights
HD (allele-selective silencing)
DMD (exon skipping)
AATD (GalNAc-RNA editing)
Obesity (GalNAc-siRNA)
RNA Medicines Platform and Pipeline Expansion
Financial Highlights
Investor Conference Call and Webcast
Wave will host an investor conference call today at 8:30 a.m. ET to review the second quarter 2024 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-publications/events. 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 Following the live event, an archived version of the webcast will be available on the Wave Life Sciences website.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 biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave’s RNA medicines platform, PRISM®, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Its toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Wave’s diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave is headquartered in Cambridge, MA. For more information on Wave’s science, pipeline and people, please visit www.wavelifesciences.com and follow Wave on X (formerly Twitter) and LinkedIn.
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 and reporting of data and completion of our clinical trials, including interactions with regulators and any potential registration based on these data, and the timing and announcement of such events; the protocol, design and endpoints of our clinical trials; the future performance and results of our programs in clinical trials; our expectations with respect to how our clinical data successes to date may predict success for our future therapeutic candidates, future clinical data readouts and further validate of our platform; ongoing and future preclinical activities and programs; regulatory submissions and timing for regulatory feedback; 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 and pipeline compared to our competitors; patient population estimates related to our therapeutic candidates; our ability to design compounds using various modalities and the anticipated benefits of that approach; the breadth and versatility of our PRISM drug discovery and development platform; 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 for certain of our programs to be best-in-class or first-in-class; the potential benefits of WVE-007, and the potential areas where we may be able to address obesity with WVE-007; the potential benefits that our “edit-verse” may provide us, including identifying 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 benefits of RNA medicines generally; the strength of our intellectual property and the data that support our IP; the anticipated duration of our cash runway and our ability to fund future operations; our intended uses of capital; and our expectations regarding the impact of any potential global macro events 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 and accelerated approval pathways, 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, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 153,958 | $ | 200,351 | ||||
| Accounts receivable | 1,290 | 21,086 | ||||||
| Prepaid expenses | 12,147 | 9,912 | ||||||
| Other current assets | 4,680 | 4,024 | ||||||
| Total current assets | 172,075 | 235,373 | ||||||
| Long-term assets: | ||||||||
| Property and equipment, net of accumulated depreciation of $44,459 and $42,709 as of June 30, 2024 and December 31, 2023, respectively | 11,783 | 13,084 | ||||||
| Operating lease right-of-use assets | 20,329 | 22,637 | ||||||
| Restricted cash | 3,731 | 3,699 | ||||||
| Other assets | 900 | 156 | ||||||
| Total long-term assets | 36,743 | 39,576 | ||||||
| Total assets | $ | 208,818 | $ | 274,949 | ||||
| Liabilities, Series A preferred shares, and shareholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 18,149 | $ | 12,839 | ||||
| Accrued expenses and other current liabilities | 10,677 | 16,828 | ||||||
| Current portion of deferred revenue | 137,138 | 150,059 | ||||||
| Current portion of operating lease liability | 7,164 | 6,714 | ||||||
| Total current liabilities | 173,128 | 186,440 | ||||||
| Long-term liabilities: | ||||||||
| Deferred revenue, net of current portion | 9,582 | 15,601 | ||||||
| Operating lease liability, net of current portion | 21,711 | 25,404 | ||||||
| Total long-term liabilities | 31,293 | 41,005 | ||||||
| Total liabilities | $ | 204,421 | $ | 227,445 | ||||
| Series A preferred shares, no par value; 3,901,348 shares issued and outstanding at June 30, 2024 and December 31, 2023 | $ | 7,874 | $ | 7,874 | ||||
| Shareholders’ equity (deficit): | ||||||||
| Ordinary shares, no par value; 122,479,289 and 119,162,234 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | $ | 950,530 | $ | 935,367 | ||||
| Additional paid-in capital | 135,603 | 129,237 | ||||||
| Accumulated other comprehensive loss | (279 | ) | (124 | ) | ||||
| Accumulated deficit | (1,089,331 | ) | (1,024,850 | ) | ||||
| Total shareholders’ equity (deficit) | $ | (3,477 | ) | $ | 39,630 | |||
| Total liabilities, Series A preferred shares, and shareholders’ equity (deficit) | $ | 208,818 | $ | 274,949 | ||||
| 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, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | 19,692 | $ | 22,106 | $ | 32,230 | $ | 35,035 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 40,393 | 33,314 | 73,840 | 64,293 | ||||||||||||
| General and administrative | 14,296 | 12,265 | 27,845 | 24,500 | ||||||||||||
| Total operating expenses | 54,689 | 45,579 | 101,685 | 88,793 | ||||||||||||
| Loss from operations | (34,997 | ) | (23,473 | ) | (69,455 | ) | (53,758 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Dividend income and interest income | 2,092 | 2,251 | 4,627 | 4,124 | ||||||||||||
| Other income (expense), net | (18 | ) | 118 | 347 | 1,125 | |||||||||||
| Total other income, net | 2,074 | 2,369 | 4,974 | 5,249 | ||||||||||||
| Loss before income taxes | (32,923 | ) | (21,104 | ) | (64,481 | ) | (48,509 | ) | ||||||||
| Income tax benefit (provision) | — | — | — | — | ||||||||||||
| Net loss | $ | (32,923 | ) | $ | (21,104 | ) | $ | (64,481 | ) | $ | (48,509 | ) | ||||
| Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.25 | ) | $ | (0.20 | ) | $ | (0.50 | ) | $ | (0.47 | ) | ||||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders—basic and diluted | 129,527,003 | 105,462,414 | 129,399,340 | 103,768,971 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | $ | (32,923 | ) | $ | (21,104 | ) | $ | (64,481 | ) | $ | (48,509 | ) | ||||
| Foreign currency translation | (81 | ) | (100 | ) | (155 | ) | (121 | ) | ||||||||
| Comprehensive loss | $ | (33,004 | ) | $ | (21,204 | ) | $ | (64,636 | ) | $ | (48,630 | ) | ||||
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$13.51 |
| Daily Change: | 0.32 2.43 |
| Daily Volume: | 3,590,021 |
| Market Cap: | US$2.060B |
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