Zymeworks(ZYME) - 2024 Q3 - Quarterly Results

Zymeworks Q3 2024 Corporate Update and Financial Results Corporate Highlights and Outlook Zymeworks reported significant Q3 2024 pipeline progress, including ZW171 dosing, zanidatamab NDA, and strong $374.9M cash - The first patient has been dosed in the Phase 1 clinical trial for ZW171, a treatment for advanced mesothelin (MSLN)-expressing cancers[1] - Partner Jazz Pharmaceuticals submitted a New Drug Application (NDA) for zanidatamab for second-line biliary tract cancer (BTC), with an FDA action date set for November 29[2] - The company completed its initial $30 million Share Repurchase Program, buying 2,545,402 shares at an average price of $11.79[1][8] - Zymeworks will host an R&D day on December 12, 2024, to provide updates on its ADC and TCE portfolio and discuss its expansion strategy into hematological cancers and autoimmune diseases[1][3] Financial Position and Runway | Metric | Value | Note | | :--- | :--- | :--- | | Cash Resources | $374.9 million | As of September 30, 2024 | | Projected Cash Runway | Into 2H 2027 | Includes certain anticipated regulatory milestone payments | Progression of Research & Development Programs Zymeworks is advancing wholly-owned and partnered R&D programs, with new trial initiations and promising preclinical data Wholly-Owned Programs (ZW171, ZW191, ZW220, ZW251) Zymeworks initiated ZW171 and ZW191 Phase 1 trials, with promising preclinical data for ZW220 and ZW251 targeting 2025 INDs - The first patient was dosed in the first-in-human Phase 1 trial of ZW171 for advanced MSLN-expressing cancers, including ovarian and non-small cell lung cancer (NSCLC)[4] - Patient recruitment is active for the global Phase 1 study of ZW191, which aims to enroll 145 participants with advanced solid tumors across North America, Europe, and Asia-Pacific[4] - Preclinical data for ADC candidates ZW220 (NaPi2b-targeted) and ZW251 (glypican-3-targeted) demonstrated compelling activity in various cancer models with favorable toxicology profiles[5] - The company anticipates submitting INDs for ZW220 in 1H 2025 and for ZW251 in 2H 2025[5] Zanidatamab Program (Partnered with Jazz and BeiGene) Jazz Pharmaceuticals presented positive zanidatamab data at ESMO 2024 for HER2+ mGEA and mCRC, with a global Phase 3 BTC trial recruiting - In a Phase 2 study for first-line HER2-expressing metastatic GEA, zanidatamab plus chemotherapy demonstrated a median progression-free survival (mPFS) of 15.2 months and an estimated 24-month overall survival of 65%[6] - In a Phase 2 study cohort for HER2-positive metastatic colorectal cancer, zanidatamab plus chemotherapy showed a confirmed objective response rate (cORR) of 91% with a manageable safety profile[6] - A global, randomized Phase 3 trial (NCT06282575) is actively recruiting patients to evaluate zanidatamab as a first-line treatment for advanced HER2-positive BTC[7] Business Updates Zymeworks completed its initial $30 million share repurchase program and announced a board of directors resignation - Completed the initial $30 million of its Share Repurchase Program, buying 2,545,402 shares at an average price of $11.79 per share as of October 31, 2024[8] - Hollings C Renton resigned from the board of directors, effective December 10, 2024, not due to any disagreement with the company[8] Financial Results for the Nine Months Ended September 30, 2024 Zymeworks reported nine-month revenue of $45.3 million, reduced net loss to $99.2 million, and maintained $374.9 million cash Nine-Month Financial Performance (2024 vs. 2023) | Metric (in millions) | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Revenue | $45.3 | $59.1 | | Research & Development Expense | $97.6 | $118.1 | | General & Administrative Expense | $45.3 | $55.6 | | Net Loss | $99.2 | $104.2 | - The decrease in revenue was mainly due to the transfer of responsibility for certain zanidatamab clinical trials to partner Jazz, reducing reimbursed development costs[9] - A non-cash impairment charge of $17.3 million was recorded following the decision to discontinue the zanidatamab zovodotin clinical development program[13] - As of September 30, 2024, cash resources (cash, equivalents, and marketable securities) totaled $374.9 million[17] Financial Statements Unaudited consolidated financial statements show a Q3 2024 net loss of $29.9 million and a nine-month net loss of $99.2 million Condensed Interim Consolidated Statements of Loss and Comprehensive Loss Zymeworks reported Q3 2024 revenue of $16.0 million and a net loss of $29.9 million, with a nine-month net loss of $99.2 million Statement of Loss Highlights (in thousands USD, except per share data) | Metric | Three Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | | Revenue | $16,000 | $45,273 | $59,086 | | Loss from Operations | $(34,205) | $(114,893) | $(114,632) | | Net Loss | $(29,850) | $(99,189) | $(104,192) | | Net Loss per Share (Basic) | $(0.39) | $(1.30) | $(1.53) | Condensed Consolidated Balance Sheet As of September 30, 2024, Zymeworks reported total assets of $487.2 million, liabilities of $120.2 million, and equity of $367.0 million Balance Sheet Summary (in thousands USD) | Account | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $374,867 | $456,257 | | Total Assets | $487,152 | $580,880 | | Total Liabilities | $120,174 | $116,074 | | Total Stockholders' Equity | $366,978 | $464,806 |