CAMBRIDGE, Mass., May 09, 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 first quarter ended March 31, 2024, and provided a business update.
“Since our last update, we have made excellent progress across our multimodal pipeline of novel RNA medicines and continued to advance our collaboration with GSK. We are on-track to deliver key data sets this year, which enable opportunities to unlock the broad potential of our RNA editing, silencing and splicing capabilities,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “In RNA editing, we are advancing WVE-006, having used data from healthy volunteers in RestorAATion-1 to identify a starting dose in our RestorAATion-2 study that is expected to engage target in patients. With RestorAATion-2 now underway, we remain on track to deliver expected proof of mechanism data in patients with AATD this year, which would represent the first-ever clinical demonstration of RNA editing and be an important milestone for the alpha-1 community, as well as serve to validate our wholly owned RNA editing pipeline.”
Dr. Bolno continued, “In addition to pioneering the field of RNA editing, we are working expeditiously to advance our GalNAc-siRNA INHBE program in obesity and expect to initiate a clinical trial in the first quarter of next year. In DMD and HD, we are approaching clinical data readouts as we plan to deliver multidose data for our allele-selective HD program in the second quarter and potentially registrational data from our FORWARD-53 trial in DMD in the third quarter. Our efforts to accelerate development of our INHBE program and advance our pipeline and collaborations have laid a strong foundation for Wave’s future and we look forward to demonstrating our leadership in RNA medicines as we reimagine what’s possible for science, for medicine, and for human health.”
Recent Business Highlights
AATD and AIMer pipeline (RNA editing)
Obesity (siRNA)
GSK Collaboration
DMD (exon skipping)
HD (antisense silencing)
Corporate
Financial Highlights
Investor Conference Call and Webcast
Wave will host an investor conference call today at 8:30 a.m. ET to review the first 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 announcement of such events; the protocol, design and endpoints of our clinical trials; the future performance and results of our programs in clinical trials; ongoing and 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 and pipeline compared to our competitors; 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 our GalNAc-conjugated siRNA program targeting INHBE; 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, 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, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 180,922 | $ | 200,351 | ||||
| Accounts receivable | — | 21,086 | ||||||
| Prepaid expenses | 11,139 | 9,912 | ||||||
| Other current assets | 4,706 | 4,024 | ||||||
| Total current assets | 196,767 | 235,373 | ||||||
| Long-term assets: | ||||||||
| Property and equipment, net of accumulated depreciation of $43,687 and $42,709 as of March 31, 2024 and December 31, 2023, respectively | 12,418 | 13,084 | ||||||
| Operating lease right-of-use assets | 21,502 | 22,637 | ||||||
| Restricted cash | 3,715 | 3,699 | ||||||
| Other assets | 868 | 156 | ||||||
| Total long-term assets | 38,503 | 39,576 | ||||||
| Total assets | $ | 235,270 | $ | 274,949 | ||||
| Liabilities, Series A preferred shares, and shareholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,730 | $ | 12,839 | ||||
| Accrued expenses and other current liabilities | 6,621 | 16,828 | ||||||
| Current portion of deferred revenue | 140,586 | 150,059 | ||||||
| Current portion of operating lease liability | 6,936 | 6,714 | ||||||
| Total current liabilities | 165,873 | 186,440 | ||||||
| Long-term liabilities: | ||||||||
| Deferred revenue, net of current portion | 12,536 | 15,601 | ||||||
| Operating lease liability, net of current portion | 23,598 | 25,404 | ||||||
| Total long-term liabilities | 36,134 | 41,005 | ||||||
| Total liabilities | $ | 202,007 | $ | 227,445 | ||||
| Series A preferred shares, no par value; 3,901,348 shares issued and outstanding at March 31, 2024 and December 31, 2023 | $ | 7,874 | $ | 7,874 | ||||
| Shareholders’ equity: | ||||||||
| Ordinary shares, no par value; 122,321,384 and 119,162,234 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | $ | 949,877 | $ | 935,367 | ||||
| Additional paid-in capital | 132,118 | 129,237 | ||||||
| Accumulated other comprehensive loss | (198 | ) | (124 | ) | ||||
| Accumulated deficit | (1,056,408 | ) | (1,024,850 | ) | ||||
| Total shareholders’ equity | $ | 25,389 | $ | 39,630 | ||||
| Total liabilities, Series A preferred shares, and shareholders’ equity | $ | 235,270 | $ | 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 March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 12,538 | $ | 12,929 | ||||
| Operating expenses: | ||||||||
| Research and development | 33,447 | 30,979 | ||||||
| General and administrative | 13,549 | 12,235 | ||||||
| Total operating expenses | 46,996 | 43,214 | ||||||
| Loss from operations | (34,458 | ) | (30,285 | ) | ||||
| Other income, net: | ||||||||
| Dividend income and interest income | 2,535 | 1,873 | ||||||
| Other income, net | 365 | 1,007 | ||||||
| Total other income, net | 2,900 | 2,880 | ||||||
| Loss before income taxes | (31,558 | ) | (27,405 | ) | ||||
| Income tax benefit (provision) | — | — | ||||||
| Net loss | $ | (31,558 | ) | $ | (27,405 | ) | ||
| Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.24 | ) | $ | (0.27 | ) | ||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders—basic and diluted | 129,271,678 | 102,056,712 | ||||||
| Other comprehensive loss: | ||||||||
| Net loss | $ | (31,558 | ) | $ | (27,405 | ) | ||
| Foreign currency translation | (74 | ) | (21 | ) | ||||
| Comprehensive loss | $ | (31,632 | ) | $ | (27,426 | ) | ||
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$14.27 |
| Daily Change: | -0.08 -0.56 |
| Daily Volume: | 441,344 |
| Market Cap: | US$1.780B |
November 12, 2024 October 30, 2024 October 16, 2024 | |
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