Full Press Release Details
VANCOUVER, British Columbia and BOSTON, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.
“2025 marked a period of significant momentum and strong execution across multiple Phase 3 clinical trials of azetukalner in epilepsy and neuropsychiatry, as well as our early-stage pipeline that includes two novel ion channel modulators for pain,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “We’re looking forward to several upcoming milestones, starting with reporting topline data for our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures in the first half of March, followed by an anticipated NDA submission in the second half of this year.”
Business Highlights and Anticipated Milestones
Azetukalner Clinical Development
Azetukalner, a novel, potent KV7 potassium channel opener, represents the most advanced, clinically-validated potassium channel modulator in late-stage clinical development for the treatment of multiple indications, including two in epilepsy – focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS) – as well as neuropsychiatric disorders, including major depressive disorder (MDD) and bipolar depression (BPD).
Epilepsy Programs
Depression Programs
Early-Stage R&D
Xenon continues to expand its portfolio of innovative potassium and sodium channel modulators. NaV1.7 and KV7 are important targets for pain and have been developed using the Company’s strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to design potent, selective ion channel modulators.
Pain
Epilepsy
Partnered Program
Corporate
Fourth Quarter and Full Year 2025 Financial Results
About Azetukalner
Azetukalner is a novel, potent KV7 potassium channel opener currently in Phase 3 clinical trials for the treatment of epilepsy, major depressive disorder (MDD) and bipolar depression (BPD). It represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development. Azetukalner is designed to open potassium channels in the central nervous system, allowing potassium ions to flow and hyperpolarizing neurons. This process helps reduce excessive neuronal firing, which is a key contributor to several neurologic and psychiatric disorders. It is the only KV7 potassium channel opener in development for multiple indications that is backed by long-term efficacy and safety data in epilepsy patients and proof-of-concept data in MDD patients.
About Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals (Nasdaq: XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need. Xenon’s lead molecule, azetukalner, is a novel, potent KV7 potassium channel opener in Phase 3 clinical trials for the treatment of epilepsy, major depressive disorder (MDD) and bipolar depression (BPD). Xenon is also advancing an early-stage portfolio of multiple promising potassium and sodium channel modulators, including KV7 and NaV1.7 programs in Phase 1 development for the potential treatment of pain. Xenon has offices in Vancouver, British Columbia, and Boston, Massachusetts. For more information, visitwww.xenon-pharma.comand follow us onLinkedInandX.
Xenon and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in the US, Canada, and elsewhere. All other trademarks belong to their respective owner.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and potential results from clinical studies; the potential efficacy, safety profile, future development plans in current and anticipated indications, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; the efficacy of our clinical study designs; our ability to successfully develop and achieve milestones in our azetukalner and other pipeline and development programs, including the anticipated filing of INDs and NDAs; the timing and results of our interactions with regulators, including the timing of any NDA submission; our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates; and anticipated timing of topline data readout from our clinical studies of azetukalner. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical studies may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; promising results from pre-clinical development activities or early clinical study results may not be replicated in later clinical studies; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including azetukalner, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation or completion of clinical studies; the impact of market, industry, and regulatory conditions on clinical study enrollment; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; the impact of unstable economic conditions in the general domestic and global economic markets; adverse conditions from geopolitical events; as well as the other risks identified in our filings with the U.S. Securities and Exchange Commission and the securities commissions in British Columbia, Alberta, and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
| December 31, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash, cash equivalents and marketable securities | $ | 548,886 | $ | 626,905 | |||
| Other current assets | 11,763 | 8,359 | |||||
| Marketable securities, long-term | 37,152 | 127,496 | |||||
| Other long-term assets | 35,362 | 35,379 | |||||
| Total assets | $ | 633,163 | $ | 798,139 | |||
| Liabilities | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 40,260 | $ | 34,221 | |||
| Other current liabilities | 1,532 | 1,369 | |||||
| Other long-term liabilities | 9,611 | 7,646 | |||||
| Total liabilities | $ | 51,403 | $ | 43,236 | |||
| Shareholders’ equity | $ | 581,760 | $ | 754,903 | |||
| Total liabilities and shareholders’ equity | $ | 633,163 | $ | 798,139 |
XENON PHARMACEUTICALS INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(Expressed in thousands of U.S. dollars except share and per share amounts)
| Three Months EndedDecember 31, | Year EndedDecember 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | $ | — | $ | — | $ | 7,500 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 87,699 | 59,472 | 300,938 | 210,394 | ||||||||||||
| General and administrative | 22,068 | 18,005 | 79,632 | 68,904 | ||||||||||||
| Total operating expenses | 109,767 | 77,477 | 380,570 | 279,298 | ||||||||||||
| Loss from operations | (109,767 | ) | (77,477 | ) | (373,070 | ) | (279,298 | ) | ||||||||
| Other income | 5,044 | 7,944 | 28,176 | 40,879 | ||||||||||||
| Loss before income taxes | (104,723 | ) | (69,533 | ) | (344,894 | ) | (238,419 | ) | ||||||||
| Income tax recovery (expense) | (538 | ) | 3,848 | (1,016 | ) | 4,089 | ||||||||||
| Net loss | $ | (105,261 | ) | $ | (65,685 | ) | $ | (345,910 | ) | $ | (234,330 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | (142 | ) | (2,948 | ) | 1,947 | (1,535 | ) | |||||||||
| Comprehensive loss | $ | (105,403 | ) | $ | (68,633 | ) | $ | (343,963 | ) | $ | (235,865 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (1.31 | ) | $ | (0.84 | ) | $ | (4.36 | ) | $ | (3.01 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 80,126,081 | 78,386,640 | 79,253,751 | 77,894,643 |