Wave Life Sciences .(US:WVE)2025-05-08 11:45PART I - FINANCIAL INFORMATION Financial Statements This section presents the unaudited consolidated financial statements for Q1 2025, detailing financial position, operations, equity, and cash flows with accompanying notes Unaudited Consolidated Balance Sheets As of March 31, 2025, total assets decreased to $288.3 million from $352.2 million at year-end 2024, primarily due to reduced cash and cash equivalents Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $243,075 | $302,078 | | Total current assets | $257,976 | $320,394 | | Total assets | $288,343 | $352,207 | | Liabilities & Equity | | | | Total current liabilities | $87,367 | $110,953 | | Total liabilities | $108,666 | $134,818 | | Total shareholders' equity | $171,803 | $209,515 | Unaudited Consolidated Statements of Operations and Comprehensive Loss For Q1 2025, the company reported revenue of $9.2 million and a net loss of $46.9 million, an increase from the $31.6 million net loss in Q1 2024 Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $9,175 | $12,538 | | Research and development | $40,622 | $33,447 | | General and administrative | $18,357 | $13,549 | | Loss from operations | $(49,804) | $(34,458) | | Net loss | $(46,878) | $(31,558) | | Net loss per share | $(0.29) | $(0.24) | Unaudited Consolidated Statements of Series A Preferred Shares and Shareholders' Equity Total shareholders' equity decreased to $171.8 million by March 31, 2025, primarily due to the quarterly net loss, partially offset by capital inflows - Total shareholders' equity decreased by $37.7 million during Q1 2025, from $209.5 million to $171.8 million, mainly due to the quarterly net loss of $46.9 million21 Unaudited Consolidated Statements of Cash Flows The company used $63.0 million in cash for operating activities during Q1 2025, resulting in a net decrease in cash, cash equivalents, and restricted cash of $59.0 million Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(63,039) | $(33,432) | | Net cash used in investing activities | $(165) | $(417) | | Net cash provided by financing activities | $4,155 | $14,510 | | Net decrease in cash | $(58,991) | $(19,413) | Notes to Unaudited Consolidated Financial Statements The notes detail the company's business, liquidity, collaboration agreements, and a breakdown of research and development expenses by program - The company expects its existing cash and cash equivalents of $243.1 million as of March 31, 2025, to be sufficient to fund operations for at least the next twelve months30 - Under the GSK Collaboration Agreement, the company recognized $9.2 million in revenue for Q1 2025. As of March 31, 2025, the total unsatisfied transaction price allocated to performance obligations is $74.45 million5357 - The Takeda collaboration expired in October 2024. Consequently, no revenue was recognized under this agreement in Q1 2025, compared to $0.3 million in Q1 20245960 Research and Development Expenses by Program (Q1 2025, in thousands) | Program | Expense | | :--- | :--- | | AATD program | $1,446 | | INHBE program (Obesity) | $2,539 | | DMD program | $3,038 | | HD program | $1,167 | | Other R&D expenses | $32,432 | | Total R&D Expenses | $40,622 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's RNA medicines platform, clinical pipeline progress, and financial performance, including revenue, net loss, and liquidity - The company is advancing a diversified pipeline of RNA medicines, with clinical programs in obesity, alpha-1 antitrypsin deficiency (AATD), Duchenne muscular dystrophy (DMD), and Huntington's disease (HD)71 - Key clinical updates include: - Obesity (WVE-007): Phase 1 trial initiated, with clinical data expected in the second half of 2025 - AATD (WVE-006): Positive proof-of-mechanism data demonstrated; further data from multidose and single dose cohorts expected in Q3 2025 and fall 2025 - DMD (WVE-N531): Positive 48-week data showed significant functional improvement; plan to file for accelerated approval in 2026 - HD (WVE-003): Positive Phase 1b/2a data showed potent mHTT reduction; preparing for a global Phase 2/3 study with an IND submission planned for the second half of 2025828694102104 Comparison of Operations (Q1 2025 vs Q1 2024, in thousands) | Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $9,175 | $12,538 | $(3,363) | | Research and development | $40,622 | $33,447 | $7,175 | | General and administrative | $18,357 | $13,549 | $4,808 | | Net loss | $(46,878) | $(31,558) | $(15,320) | - As of March 31, 2025, the company had cash and cash equivalents of $243.1 million, which is expected to be sufficient to fund operations for at least the next twelve months130131 Quantitative and Qualitative Disclosures About Market Risk The company identifies primary market risks including interest rate, foreign currency, inflation, and capital market risks, impacting operations and future funding - The company's main market risks are identified as interest rate risk on cash holdings, foreign currency risk from international operations, inflation risk on operating costs, and capital market risk related to future funding needs149 - The company does not currently hedge its foreign currency exposure and acknowledges that continued global inflation could lead to appreciable increases in clinical trial and labor costs151152 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of March 31, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level155 - There were no changes in internal control over financial reporting during the first quarter of 2025 that have materially affected, or are reasonably likely to materially affect, these controls156 PART II - OTHER INFORMATION Legal Proceedings The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings158 Risk Factors This section refers readers to the 'Risk Factors' section of the company's Annual Report on Form 10-K for a comprehensive discussion of potential risks and uncertainties - For a detailed discussion of risk factors, the report refers to Item 1A of the company's 2024 Annual Report on Form 10-K159 Unregistered Sales of Equity Securities and Use of Proceeds The company reports that there were no unregistered sales of its equity securities and no repurchases during the first quarter of 2025 - The company made no unregistered sales of equity securities and did not repurchase any of its equity securities during the three months ended March 31, 2025160161 Defaults Upon Senior Securities The company reports that there have been no defaults upon its senior securities - No defaults upon senior securities were reported162 Mine Safety Disclosures This item is not applicable to the company's business - This section is not applicable163 Other Information This section discloses that several officers and directors adopted Rule 10b5-1 trading plans in March 2025 for the pre-planned sale of company shares - During Q1 2025, certain officers and directors adopted Rule 10b5-1 trading plans for the sale of company securities164 - On March 13, 2025, CFO Kyle Moran adopted a plan for the sale of up to 296,000 shares, and three board members adopted plans for the sale of an aggregate of 313,845 shares165166167168 Exhibits This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents - The report includes certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, and 32) and Inline XBRL data files170