XENE 8-K
Xenon Pharmaceuticals Inc. (XENE)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 |
Results of Operations and Financial Condition |
On February 26, 2026, Xenon Pharmaceuticals Inc. (the “Company”) announced via press release the Company’s financial results for the year ended December 31, 2025. A copy of the Company’s press release is attached hereto as Exhibit 99.1. The information in Item 2.02 of this Form 8-K and the attached exhibit are furnished to, but not filed with, the Securities and Exchange Commission.
Item 7.01 |
Regulation FD Disclosure |
The Company announces material information to the public through a variety of means, including filings with the Securities and Exchange Commission, press releases, public conference calls, the Company’s website (https://www.xenon-pharma.com), its investor relations website (https://investor.xenon-pharma.com), and its news site (https://investor.xenon-pharma.com/news-releases). The Company uses these channels, as well as social media, including its X (formerly known as Twitter) account (@XenonPharma), LinkedIn account (https://www.linkedin.com/company/xenonpharma/), and Facebook page (https://www.facebook.com/xenonpharma), to communicate with investors and the public about the Company, its product candidates, and other matters. Therefore, the Company encourages investors, the media, and others interested in the Company to review the information it makes public in these locations, as such information could be deemed to be material information.
Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits.
Pursuant to the rules and regulations of the Securities and Exchange Commission, the attached exhibit is deemed to have been furnished to, but not filed with, the Securities and Exchange Commission:
Exhibit Number |
Description |
99.1 |
Press Release issued by Xenon Pharmaceuticals Inc. dated February 26, 2026. |
104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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XENON PHARMACEUTICALS INC. |
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Date: February 26, 2026 |
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By: |
/s/ Thomas P. Kelly |
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Thomas P. Kelly |
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Chief Financial Officer |

Exhibit 99.1
Xenon Reports Q4 and Full Year 2025 Financial Results and Provides Business Update
VANCOUVER, British Columbia and BOSTON, MA, Feb 26, 2026 – 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 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, visit www.xenon-pharma.com and follow us on LinkedIn and X.
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.
Contacts
For Investors:
Tucker Kelly
Chief Financial Officer
For Media:
Colleen Alabiso
Senior Vice President, Corporate Affairs
XENON PHARMACEUTICALS INC.
Condensed Consolidated Balance Sheets
(Expressed in thousands of U.S. dollars)
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December 31, |
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December 31, |
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2025 |
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2024 |
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Assets |
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Current assets: |
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Cash, cash equivalents and marketable securities |
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$ |
548,886 |
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$ |
626,905 |
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Other current assets |
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11,763 |
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8,359 |
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Marketable securities, long-term |
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37,152 |
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127,496 |
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Other long-term assets |
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35,362 |
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35,379 |
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Total assets |
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$ |
633,163 |
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$ |
798,139 |
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Liabilities |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
40,260 |
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$ |
34,221 |
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Other current liabilities |
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1,532 |
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1,369 |
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Other long-term liabilities |
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9,611 |
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7,646 |
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Total liabilities |
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$ |
51,403 |
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$ |
43,236 |
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Shareholders’ equity |
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$ |
581,760 |
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$ |
754,903 |
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Total liabilities and shareholders’ equity |
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$ |
633,163 |
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$ |
798,139 |
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XENON PHARMACEUTICALS INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Expressed in thousands of U.S. dollars except share and per share amounts)
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Three Months Ended |
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Year Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue |
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$ |
— |
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$ |
— |
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$ |
7,500 |
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$ |
— |
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Operating expenses: |
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Research and development |
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87,699 |
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59,472 |
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300,938 |
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210,394 |
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General and administrative |
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22,068 |
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18,005 |
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79,632 |
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68,904 |
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Total operating expenses |
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109,767 |
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77,477 |
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380,570 |
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279,298 |
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Loss from operations |
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(109,767 |
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(77,477 |
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(373,070 |
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(279,298 |
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Other income |
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5,044 |
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7,944 |
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28,176 |
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40,879 |
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Loss before income taxes |
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(104,723 |
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(69,533 |
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(344,894 |
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(238,419 |
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Income tax recovery (expense) |
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(538 |
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3,848 |
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(1,016 |
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4,089 |
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Net loss |
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$ |
(105,261 |
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$ |
(65,685 |
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$ |
(345,910 |
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$ |
(234,330 |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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(142 |
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(2,948 |
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1,947 |
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(1,535 |
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Comprehensive loss |
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$ |
(105,403 |
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$ |
(68,633 |
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$ |
(343,963 |
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$ |
(235,865 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(1.31 |
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$ |
(0.84 |
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$ |
(4.36 |
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$ |
(3.01 |
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Weighted average common shares outstanding: |
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Basic and diluted |
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80,126,081 |
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78,386,640 |
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79,253,751 |
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77,894,643 |
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