CAMBRIDGE, Mass., Oct. 16, 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 it will host a virtual Research Day on Wednesday, October 30, 2024 at 10:00 a.m. ET (until 11:30 a.m. ET). During the event, Wave will provide an update on its rapidly advancing, wholly owned pipeline, introduce new GalNAc-conjugated RNA editing and siRNA programs, and discuss its ...

CAMBRIDGE, Mass., Oct. 01, 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, announced today that it closed its previously announced underwritten public offering, and that the underwriters exercised in full their option to purchase an additional 3,750,000 of its ordinary shares at the public offering price of $8.00 per ordinary share, less underwriting discounts and commi ...

Shares of Wave Life Sciences (WVE) surged 53.4% on Tuesday after the company announced positive interim data from a mid-stage study evaluating its investigational candidate, WVE-N531, to treat boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping. WVE-N531, an exon skipping oligonucleotide, is currently being developed as a disease-modifying treatment for DMD indication in boys. The candidate enjoys the FDA's Orphan Drug and Rare Pediatric Disease designations in the United States ...

CAMBRIDGE, Mass., Sept. 24, 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, announced today that it has commenced an underwritten public offering of $175 million in aggregate of its ordinary shares, and, to certain investors that so choose in lieu of ordinary shares, pre-funded warrants to purchase ordinary shares. In connection with the offering, Wave intends to grant ...

Mean muscle content-adjusted dystrophin expression of 9.0% and unadjusted dystrophin of 5.5%, with high consistency across participants, in a prespecified analysis; dystrophin was comprised of two isoforms consistent with Becker muscular dystrophy patients who display milder disease Data demonstrated meaningful improvement in serum biomarkers for muscle health, with localization of WVEN531 in myogenic stem cells and regeneration of myofibers Skeletal muscle concentrations of ~41,000 ng/g combined with 61-da ...

Clinical Development - The company initiated the RestorAATion clinical program for WVE-006 in Q4 2023, targeting Alpha-1 antitrypsin deficiency (AATD) with a focus on restoring wild-type AAT protein levels in serum [51]. - WVE-006 achieved serum AAT protein levels of up to 30 micromolar in preclinical models, restoring approximately 50% wild-type M-AAT protein and demonstrating a 3-fold increase in neutrophil elastase inhibition activity [53]. - The company is advancing WVE-007, a GalNAc-siRNA targeting INHBE for obesity, with preclinical data showing significant weight loss and fat reduction in diet-induced obesity models [54]. - WVE-N531 is designed to skip exon 53 in the dystrophin gene, addressing approximately 8-10% of Duchenne muscular dystrophy (DMD) cases, with positive proof-of-concept data from early trials [56]. - The Phase 2 trial for WVE-N531 (FORWARD-53) has been initiated, with results expected in Q3 2024, focusing on dystrophin protein levels and safety [58]. - WVE-003 is being developed for Huntington's disease, targeting a specific SNP associated with the disease, with the potential to address up to 80% of the HD population in future [59]. - The SELECT-HD trial showed a statistically significant reduction of up to 46% in cerebrospinal fluid mHTT levels with WVE-003, indicating potential benefits for early-stage HD patients [63]. Financial Performance - For the three months ended June 30, 2024, the company reported a net loss of $32.9 million, compared to a net loss of $21.1 million for the same period in 2023, reflecting an increase of $11.8 million [67]. - Total operating expenses for Q2 2024 were $54.7 million, up from $45.6 million in Q2 2023, marking an increase of $9.1 million [77]. - Research and development expenses rose to $40.4 million in Q2 2024, compared to $33.3 million in Q2 2023, an increase of approximately $7.1 million [82]. - The company has an accumulated deficit of $1,089.3 million as of June 30, 2024, up from $1,024.9 million at the end of 2023 [67]. - Revenue for the six months ended June 30, 2024, was $32.2 million, a decrease of approximately 8.1% from $35.0 million in the same period of 2023 [84]. - Total operating expenses increased to $101.7 million in the first half of 2024, up from $88.8 million in 2023, representing a rise of approximately 14.5% [84]. - Research and development expenses rose to $73.8 million in the first half of 2024, an increase of about 14.8% compared to $64.3 million in 2023 [84]. - General and administrative expenses were $27.8 million for the six months ended June 30, 2024, up from $24.5 million in 2023, reflecting an increase of approximately 13.5% [85]. - Net loss for the six months ended June 30, 2024, was $64.5 million, compared to a net loss of $48.5 million in 2023, indicating an increase in loss of approximately 33.0% [84]. - Cash and cash equivalents totaled $154.0 million as of June 30, 2024, with an accumulated deficit of $1,089.3 million [88]. - Net cash used in operating activities was $60.9 million for the six months ended June 30, 2024, compared to a net cash provided of $48.3 million in 2023 [89]. - Net cash provided by financing activities was $15.2 million in the first half of 2024, down from $36.9 million in the same period of 2023 [92]. Collaborations and Partnerships - The collaboration with GlaxoSmithKline (GSK) includes potential milestone payments of up to $525 million and double-digit tiered royalties for WVE-006, with a $20 million milestone payment already achieved [52]. - GSK selected two programs for development candidates, triggering a $12 million initiation payment [66]. - The GSK collaboration agreement generated revenue of $19.7 million in Q2 2024, a decrease from $22.1 million in Q2 2023 [78]. Future Outlook and Risks - The company expects to continue incurring significant operating losses and expenses in the foreseeable future [67]. - The company has not generated any product revenue since inception and does not expect to do so in the near future [68]. - The company anticipates continued significant expenses related to ongoing research and development activities and internal manufacturing [93]. - The company may face delays and issues in drug candidate development due to various risks, including regulatory challenges and safety issues [95]. - Future capital requirements for therapeutic programs will depend on research progress, costs, and the number of product candidates pursued [95]. - The company currently has no committed external funding sources, relying on potential future payments from collaborations with Takeda and GSK [95]. - The company is exposed to interest rate risk due to fluctuations in interest rates affecting cash and cash equivalents [97]. - Foreign currency exchange rate changes could materially impact the company's financial condition, although no significant effects were noted in the past two years [98]. - Inflation trends may lead to increased clinical trial, labor, and operating costs in the future [99]. - The company has no product revenues and relies on funds raised through equity offerings, which are influenced by capital market conditions [100]. Research and Development Strategy - The company maintains a robust pipeline of RNA-targeting modalities, leveraging novel chemistry to enhance the pharmacological properties of oligonucleotides [46]. - The company’s RNA medicines platform, PRISM®, combines multiple modalities and deep insights into human genetics to address both rare and prevalent disorders [46]. - The strategic focus on oligonucleotides allows the company to avoid risks associated with DNA editing and gene therapy, while leveraging established manufacturing processes [47].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File Number: 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore (State or other juris ...

Exhibit 99.1 Wave Life Sciences Reports First Quarter 2024 Financial Results and Provides Business Update RestorAATion-2 clinical trial of WVE-006 in AATD patients underway; expected proof-of-mechanism data in patients with AATD remains on track for 2024 INHBE program for obesity expected clinical trial initiation in 1Q 2025; preclinical data demonstrate weight loss similar to semaglutide, fat loss with no loss of muscle mass, and curtailed rebound weight gain upon cessation of semaglutide, with potential f ...

Wave Life Sciences Ltd. (NASDAQ:WVE) Q4 2023 Earnings Call Transcript March 6, 2024 8:30 AM ET Company Participants Kate Rausch - Vice President, Investor Relations & Corporate Affairs Paul Bolno - President & Chief Executive Officer Anne-Marie Li-Kwai-Cheung - Chief Development Officer Kyle Moran - Chief Financial Officer Conference Call Participants Timur Ivannikov - Raymond James Salim Syed - Mizuho Joon Lee - Truist Joseph Schwartz - Leerink Partners Luca Issi - RBC Capital Andrew Fein - H.C. Wainwright ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore 98-1356880 (State or other jurisdiction of i ...