Xenon Pharmaceuticals Inc 8-K, filed Nov 9, 2026
Xenon Pharmaceuticals Inc. (XENE)
About this 8-K
Xenon Pharmaceuticals Inc filed this 8-K on November 9, 2026.
Xenon Pharmaceuticals Inc. submitted azetukalner’s drug application for focal seizures to the FDA in September 2026, reported $1.2 billion in cash, cash equivalents and marketable securities with cash runway into 2029, and expects X-NOVA2 results in December 2026. AI summary
Items reported
- Item 2.02: Financial results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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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).
Emerging growth company
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 November 9, 2026, Xenon Pharmaceuticals Inc. (the “Company”) announced via press release the Company’s financial results for the three and nine months ended September 30, 2026. 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) and LinkedIn account (https://www.linkedin.com/company/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 November 9, 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: November 9, 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 Q3 2026 Financial Results and Provides Business Update
VANCOUVER, BC and BOSTON, MA, November 9, 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 third quarter ended September 30, 2026 and provided a business update.
“We've made significant progress advancing azetukalner with our recent NDA submission to the FDA for focal seizures and through ongoing scientific exchange opportunities. We continue to have great confidence in azetukalner’s product profile in epilepsy based on strong efficacy and consistent safety across more than 1,500 patient-years of data, which has been reiterated in conversations with both epileptologists and neurologists,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “Following the completion of enrollment in X-NOVA2, we are working toward our first Phase 3 data readout in psychiatry with topline results now expected in December 2026. We also are excited about the growing value of our earlier stage pipeline as seen through the recent announcement of positive Phase 1 data for our novel, non-opioid pain programs, XEN1701 and XEN1120, which we are planning to progress to Phase 2 proof-of-concept studies in acute pain in the first half of 2027.”
Business Highlights and Anticipated Milestones
Azetukalner Development Program
Azetukalner is a novel, potent KV7 potassium channel opener in late-stage development for multiple potential indications, including two in epilepsy – focal seizures (FS) and primary generalized tonic-clonic seizures (PGTCS) – as well as neuropsychiatric disorders, including major depressive disorder (MDD) and bipolar depression (BPD).
Epilepsy Programs
Neuropsychiatry Programs
Clinical Programs for Pain
Xenon continues to expand its portfolio of potent, selective ion channel modulators using the Company’s strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries. This includes clinical-stage candidates targeting NaV1.7 and KV7, which are important novel targets for non-opioid pain therapeutics.
NaV1.7 Programs
KV7 Program
Early-Stage R&D and Partnered Programs for Epilepsy
Beyond azetukalner, Xenon is committed to advancing additional novel treatment approaches to address significant unmet needs in epilepsy.
Upcoming Investor Conferences
Q3 2026 Financial Results
Conference Call Information
Xenon will host a conference call and webcast today at 4:30 pm EST (2:30 pm PCT) to discuss its third quarter 2026 results. A listen-only webcast can be accessed on the Investors section of the Xenon website, with a replay available following the event. Participants can access the conference call by dialing (800) 715-9871 or (646) 307-1963 for international callers and referencing conference ID 8984105.
About Azetukalner
Azetukalner is a novel, potent KV7 potassium channel opener currently in development for the treatment of epilepsy, major depressive disorder and bipolar depression. 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.
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 late-stage clinical development for the treatment of epilepsy, major depressive disorder and bipolar depression. 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 U.S., 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 status 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 achieve milestones in our azetukalner and other pipeline and development programs, including the anticipated filing of INDs (or equivalent) and NDAs, initiation of clinical studies, completion of trial enrollment and timing of topline data readout from any clinical studies; the timing and results of our interactions with regulators; and our ability to successfully develop, obtain regulatory approval for, and commercialize azetukalner and our other product candidates. 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 preclinical 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 preclinical 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 delay the initiation or completion of clinical studies or impose additional requirements prior to approval; 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:
Laura Perry/Emily Huang
Argot Partners
Xenon@argotpartners.com
For Media:
Colleen Alabiso
Senior Vice President, Corporate Affairs
media@xenon-pharma.com
XENON PHARMACEUTICALS INC.
Condensed Consolidated Balance Sheets
(Expressed in thousands of U.S. dollars)
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September 30, |
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December 31, |
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2026 |
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2025 |
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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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$ |
950,798 |
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$ |
548,886 |
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Other current assets |
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9,267 |
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11,763 |
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Marketable securities, non-current |
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202,680 |
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37,152 |
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Other non-current assets |
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37,130 |
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35,362 |
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Total assets |
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$ |
1,199,875 |
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$ |
633,163 |
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Liabilities |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
44,154 |
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$ |
40,260 |
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Other current liabilities |
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1,150 |
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1,532 |
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Other non-current liabilities |
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8,189 |
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9,611 |
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Total liabilities |
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53,493 |
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51,403 |
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Shareholders’ equity |
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1,146,382 |
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581,760 |
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Total liabilities and shareholders’ equity |
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$ |
1,199,875 |
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$ |
633,163 |
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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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Nine Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue |
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$ |
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— |
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$ |
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— |
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$ |
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— |
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$ |
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7,500 |
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Operating expenses: |
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Research and development |
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95,645 |
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77,054 |
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283,377 |
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213,239 |
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General and administrative |
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24,422 |
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19,282 |
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72,173 |
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57,564 |
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Total operating expenses |
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120,067 |
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96,336 |
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355,550 |
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270,803 |
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Loss from operations |
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(120,067 |
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(96,336 |
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(355,550 |
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(263,303 |
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Other income |
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11,475 |
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6,117 |
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30,764 |
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23,132 |
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Loss before income taxes |
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(108,592 |
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(90,219 |
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(324,786 |
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(240,171 |
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Income tax recovery (expense) |
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(1,843 |
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(677 |
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1,313 |
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(478 |
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Net loss |
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$ |
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(110,435 |
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$ |
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(90,896 |
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$ |
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(323,473 |
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$ |
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(240,649 |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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(2,397 |
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364 |
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(5,388 |
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2,089 |
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Comprehensive loss |
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$ |
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(112,832 |
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$ |
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(90,532 |
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$ |
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(328,861 |
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$ |
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(238,560 |
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Net loss per common share: |
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Basic and diluted |
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$ |
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(1.11 |
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$ |
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(1.15 |
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$ |
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(3.38 |
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$ |
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(3.05 |
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Weighted-average common shares outstanding: |
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Basic and diluted |
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99,765,663 |
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79,247,976 |
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95,573,728 |
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78,962,975 |
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