Core Viewpoint - Wave Life Sciences (WVE) is anticipated to report a year-over-year decline in earnings despite an increase in revenues for the quarter ended March 2025, which could significantly influence its stock price based on actual results compared to estimates [1][2]. Company Summary - The consensus estimate indicates a quarterly loss of $0.27 per share for Wave Life Sciences, reflecting a year-over-year change of -12.5%. Revenues are projected to be $13.97 million, representing an 11.4% increase from the previous year [3]. - Over the last 30 days, the consensus EPS estimate has been revised 0.43% lower, indicating a reassessment by analysts regarding the company's earnings prospects [4]. - The Most Accurate Estimate for Wave Life Sciences is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -1.89%. The company currently holds a Zacks Rank of 3, making it challenging to predict an earnings beat [10][11]. Earnings Surprise History - In the last reported quarter, Wave Life Sciences was expected to post a loss of $0.17 per share but instead reported earnings of $0.17, resulting in a surprise of +200%. However, the company has only beaten consensus EPS estimates once in the last four quarters [12][13]. Industry Context - Rhythm Pharmaceuticals, another company in the Zacks Medical - Biomedical and Genetics industry, is expected to report a loss of $0.69 per share for the same quarter, indicating a year-over-year change of +70.6%. Its revenues are expected to be $40.18 million, up 54.7% from the previous year [17]. - The consensus EPS estimate for Rhythm Pharmaceuticals has been revised 0.7% lower in the last 30 days, leading to an Earnings ESP of -12.84% and a Zacks Rank of 3, complicating predictions for an earnings beat [18].

CAMBRIDGE, Mass., May 01, 2025 (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, will host a live webcast and conference call at 8:30 a.m. ET on Thursday, May 8, 2025, to review the company’s first quarter 2025 financial results and provide business updates. The webcast and conference call may be accessed by visiting “Investor Events” on the investors section of the Wave Life ...

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Company Overview - Wave Life Sciences (WVE) shares increased by 6.1% to $10.02, following a significant trading volume, contrasting with an 8.9% decline over the past four weeks [1] - The company is focused on developing treatments for Duchenne muscular dystrophy (DMD) [2] Clinical Study Results - The stock's rally was driven by positive results from the phase II FORWARD-53 study, which assessed WVE-N531 for DMD treatment [2] - The study met all objectives, showing sustained exon skipping, muscle concentrations, and dystrophin restoration over 48 weeks, with a 61-day tissue half-life supporting monthly dosing [2] - Treatment with WVE-N531 was reported to be safe and well-tolerated [2] Financial Expectations - The upcoming quarterly report is expected to show a loss of $0.26 per share, reflecting an 8.3% year-over-year decline, while revenues are projected at $13.26 million, a 5.8% increase from the previous year [3] - The consensus EPS estimate for the quarter has been revised 9.8% higher in the last 30 days, indicating potential price appreciation [4] Industry Context - Wave Life Sciences operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Agios Pharmaceuticals (AGIO), has seen a 12.6% decline over the past month [4] - Agios Pharmaceuticals' EPS estimate has decreased by 5.4% over the past month, indicating a challenging outlook compared to the previous year [5]

Statistically significant and clinically meaningful improvement of 3.8 seconds in Time-to-Rise vs. natural history with largest effect observed relative to any approved dystrophin restoration therapy at 48 weeks; additional functional benefits observed in other outcome measures including NSAA First-ever demonstration of substantial improvements in muscle health with exon skipping – statistically significant reduction in fibrosis driven by decreases in inflammation and necrosis, coupled with transition from ...

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $83.7 million, compared to $29.1 million in Q4 2023, while full-year revenue was $108.3 million, down from $113.3 million in 2023 [35] - R&D expenses increased to $44.6 million in Q4 2024 from $34.1 million in Q4 2023, and for the full year, R&D expenses rose to $159.7 million from $130.0 million [35] - Net income for Q4 2024 was $29 million, compared to a net loss of $16.3 million in Q4 2023, while the full-year net loss was $96.7 million, up from $57.5 million in 2023 [35][36] - Cash and cash equivalents at year-end 2024 were $302.1 million, compared to $200.4 million at the end of 2023, primarily due to financing proceeds and milestone payments [36] Business Line Data and Key Metrics Changes - The company advanced its pipeline with WVE-007 for obesity, which is expected to provide a unique mechanism of action with dosing just once or twice a year [7][10] - WVE-006 for AATD demonstrated a mean 6.9% micromolar circulating AAT and 10.8% micromolar total AAT two weeks post single dose in the first patient study, indicating a favorable safety profile [12] - In DMD, WVE-531 showed a mean muscle content adjusted dystrophin of 9%, with a well-tolerated profile, and the company is on track to deliver 48-week data by the end of the month [15][17] Market Data and Key Metrics Changes - The obesity treatment market is highlighted as having over 1 billion people affected globally, with WVE-007 positioned to address limitations of current GLP-1 therapies [9][10] - Huntington's disease impacts more than 200,000 people in the US and Europe, with the company emphasizing the need for early intervention therapies [18][64] Company Strategy and Development Direction - The company is focused on RNA medicines, with a commitment to advancing its pipeline and addressing high unmet needs in various therapeutic areas [6][14] - WVE-007 is positioned as an alternative to GLP-1 therapies, focusing on peripheral action to avoid disadvantages associated with centrally acting drugs [29] - The company plans to initiate clinical development of additional RNA editing programs in 2026, expanding its therapeutic offerings [14][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2024 and the potential for multiple value-accretive milestones in 2025 across all clinical programs [38] - The management highlighted the importance of engaging with the obesity community and clinicians to combat disease stigma and improve treatment outcomes [8] - The company anticipates that its current cash reserves will fund operations into 2027, excluding potential future milestone payments [36] Other Important Information - The company has seen a surge in enrollment and demand for its clinical studies, particularly for WVE-006, indicating strong interest from both clinicians and patients [13] - The management emphasized the unique aspects of their RNA editing technology compared to traditional DNA editing, highlighting the safety and efficacy of their approach [12][85] Q&A Session Summary Question: Can you provide more information on WVE-006's baseline protein levels? - Management noted that the baseline was below the lower limit of detection, and emphasized tracking M-protein levels as a key indicator of therapeutic impact [40][42] Question: Regarding WVE-007, how will DEXA scanning be utilized in the study? - Management confirmed that DEXA scans will be used to assess fat loss versus muscle mass changes, with the goal of demonstrating healthy weight loss [47][48] Question: What are the expectations for the upcoming DMD data readout? - Management indicated that discussions with regulators are ongoing, and they expect to provide updates on both the 24-week and 48-week data [52][56] Question: How does the company view the potential for mutant huntingtin lowering as a surrogate endpoint in Huntington's disease? - Management expressed that if the FDA accepts this as a clinical surrogate, they would be positioned to file based on existing data showing significant mutant huntingtin reductions [61][62] Question: What has changed regarding the prevalence of Huntington's disease? - Management explained that recent research has shown that the disease begins before symptom onset, leading to a higher estimated prevalence than previously thought [64][66]

Wave Life Sciences Ltd. (NASDAQ:WVE) Q4 2024 Earnings Conference Call March 4, 2025 8:30 AM ET Company Participants Kate Rausch - VP, IR & Corporate Affairs Paul Bolno - President & CEO Erik Ingelsson - Chief Scientific Officer Kyle Moran - Chief Financial Officer Conference Call Participants Ron Feiner - JPMorgan Salim Syed - Mizuho Joon Lee - Truist Securities Joe Schwartz - Leerink Partners Roger Song - Jefferies Catherine Novack - Jones Trading Ryan Deschner - Raymond James Madison El-Saadi - B. Riley O ...

Financial Performance - The company reported net losses of $97.0 million, $57.5 million, and $161.8 million for the fiscal years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $1,121.9 million as of December 31, 2024[275]. - The company has not generated any product revenue to date and does not expect to do so in the foreseeable future, leading to continued significant operating losses[276]. - The company has received approximately $1,578.4 million in net proceeds from sales of securities and collaborations through December 31, 2024, including $977.8 million from public offerings and $511.3 million from collaborations[280]. - The company anticipates that its existing cash and cash equivalents will be sufficient to fund operations for at least the next 12 months[277]. - The company has never declared or paid cash dividends on its ordinary shares and does not anticipate doing so in the foreseeable future[460]. Capital Requirements and Funding - The company filed a shelf registration statement for the sale of up to $250.0 million in ordinary shares, allowing for potential future capital raising[281]. - The company’s future capital requirements are uncertain and will depend on various factors, including monthly spending levels and the progress of drug discovery and clinical development[279]. - The company relies on third parties for raw materials and clinical trials, which may be disrupted by local or global health epidemics, affecting research and development activities[289]. - The company faces risks related to macroeconomic conditions, including inflation and volatility in interest rates, which could impact its ability to raise additional funding[284]. Research and Development Challenges - The company has not yet demonstrated the ability to successfully complete pivotal clinical trials or obtain marketing approvals necessary for product commercialization[287]. - The company’s RNA medicines platform, PRISM, aims to target genetically defined diseases but has not yet completed successful clinical development of an oligonucleotide therapeutic[291]. - The company has invested significantly in the development of its RNA medicines platform, PRISM, and has no products currently on the market, with revenue generation expected to be many years away[295]. - The company has a diverse pipeline including clinical programs in AATD, DMD, HD, and obesity, but the success of these programs is uncertain[294]. - The company experienced a discontinuation of the WVE-004 program after Phase 1b/2a study results showed no clinical benefit, highlighting the high failure rate in drug development[312]. Regulatory and Compliance Risks - Regulatory approval processes for product candidates are extensive and costly, with unpredictable timelines that can materially impair revenue generation[319]. - The company must submit a diversity action plan for future Phase 3 trials, which may affect planning and recruitment of diverse patient populations[315]. - Regulatory authorities may suspend clinical trials if unacceptable health risks are identified, impacting the approval process for product candidates[307]. - The company is subject to ongoing regulatory oversight for marketed drugs, which includes compliance with U.S. and foreign requirements, and failure to comply could result in penalties or withdrawal of approvals[325]. Manufacturing and Supply Chain Issues - Manufacturing capabilities are being developed at a 90,000 square foot facility in Lexington, Massachusetts, which began cGMP manufacturing in early 2018[299]. - The company faces risks related to the complexity of oligonucleotide manufacturing, including potential delays and quality control issues[301]. - The company’s ability to manufacture product candidates may be hindered by supply chain disruptions, particularly for raw materials sourced from international suppliers[300]. - Increased competition for raw materials necessary for oligonucleotide production could severely impact manufacturing capabilities[376]. Market and Competitive Landscape - The pharmaceutical industry is highly competitive, with many large companies and research organizations targeting the same diseases, which could affect the company's ability to commercialize its drugs successfully[330]. - Competitors may have advantages such as greater financial resources, more extensive experience, and established products, which could adversely affect the company's competitive position[333]. - Market acceptance of the company's product candidates may be hindered, as key participants in the pharmaceutical marketplace may not adopt new technologies based on oligonucleotides[328]. Intellectual Property and Legal Risks - The company faces risks related to obtaining and enforcing market exclusivity for its technologies and product candidates, which is critical for maintaining commercial value[400]. - Legal issues regarding the patentability of biopharmaceuticals may create uncertainty and affect the company's ability to protect its intellectual property rights[401]. - The company may face challenges from third parties regarding its patent rights, which could adversely affect its ability to develop and commercialize its products[407]. - The company relies on trade secrets and confidential information for competitive advantage, but breaches of confidentiality agreements could harm its position[422]. International Operations and Taxation - The company faces risks associated with international operations, including regulatory changes and geopolitical instability, which could adversely affect its business[360]. - The company is subject to income and other taxes in the United States and foreign jurisdictions, and future changes in tax laws may adversely affect its business and financial condition[395]. - The company may be classified as a passive foreign investment company (PFIC), potentially resulting in adverse U.S. federal income tax consequences for U.S. holders[437]. Collaboration and Dependency Risks - The company commenced a collaboration with GSK in January 2023 to research, develop, and commercialize oligonucleotide therapeutics, including WVE-006, its first-in-class A-to-I(G) RNA editing candidate for AATD[365]. - Future revenues may heavily depend on the success of third-party collaborators, such as GSK, which is responsible for later clinical development and commercialization of the AATD program[369]. - The company relies on third-party collaborators for the development and commercialization of certain product candidates, which may limit control over resources and timelines[366].

Exhibit 99.1 Wave Life Sciences Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Dosing underway in INLIGHT trial of WVE-007 in obesity with clinical data expected in 2H 2025; enrollment complete in first single dose cohort Multi-dosing ongoing in 200 mg cohort of RestorAATion-2 clinical trial of WVE-006 in AATD with data expected in 2025; second single dose cohort initiated at 400 mg Recent Business Highlights and Expected Milestones GalNAc-siRNA Programs Obesity • W ...

Core Insights - Wave Life Sciences Ltd. has initiated dosing in the INLIGHT trial for WVE-007, targeting obesity, with clinical data expected in the second half of 2025 [2][3] - The company is advancing its clinical studies for WVE-006 in Alpha-1 antitrypsin deficiency (AATD) and WVE-N531 in Duchenne muscular dystrophy (DMD), with significant data anticipated in 2025 [2][3][6] - Financially, Wave reported cash and cash equivalents of $302.1 million as of December 31, 2024, providing a runway into 2027 [8][11] GalNAc-siRNA Programs - WVE-007 is designed to silence INHBE mRNA, showing potential for significant weight loss comparable to semaglutide, with a single dose leading to weight loss without muscle loss [3] - The INLIGHT trial is a first-in-human, placebo-controlled study assessing safety, tolerability, and metabolic health in adults with obesity, with enrollment in the first single dose cohort completed [3] - Expected clinical data from INLIGHT will include safety and biomarkers reflective of healthy weight loss, anticipated in the second half of 2025 [3] AATD and RNA Editing Programs - WVE-006 is a GalNAc-conjugated oligonucleotide targeting AATD, with ongoing multi-dosing in the RestorAATion-2 clinical trial [6] - Initial proof-of-mechanism data from WVE-006 demonstrated a mean circulating wild-type M-AAT protein level of 6.9 micromolar, representing over 60% of total AAT [6] - Multi-dose data for WVE-006 is expected to be shared in 2025, with the potential for extended dosing intervals [6] DMD Programs - WVE-N531 is an exon skipping oligonucleotide for DMD, with ongoing trials showing positive interim results, including a mean dystrophin expression of 9.0% [6] - The FORWARD-53 trial is evaluating the safety and efficacy of WVE-N531, with 48-week data and regulatory feedback expected in the first quarter of 2025 [6] Financial Highlights - Revenue for the fourth quarter of 2024 was $83.7 million, up from $29.1 million in the prior year quarter, while total revenue for 2024 was $108.3 million compared to $113.3 million in 2023 [11] - Research and development expenses increased to $44.6 million in Q4 2024 from $34.1 million in Q4 2023, with full-year expenses at $159.7 million compared to $130.0 million in 2023 [11] - The net income for Q4 2024 was $29.3 million, a significant improvement from a net loss of $16.3 million in the same quarter of the previous year [11]