Xenon Pharmaceuticals Inc 8-K, filed Nov 3, 2025
Xenon Pharmaceuticals Inc. (XENE)
About this 8-K
Xenon Pharmaceuticals Inc filed this 8-K on November 3, 2025.
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):
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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 3, 2025, Xenon Pharmaceuticals Inc. (the “Company”) announced via press release the Company’s financial results for the three and nine months ended September 30, 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 November 3, 2025. |
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 3, 2025 |
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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 Third Quarter 2025 Financial Results & Business Update
– Phase 3 X-TOLE2 FOS topline data on track to read out early 2026 with patient randomization complete
– Phase 3 X-NOVA2 and X-NOVA3 studies in MDD & Phase 3 X-CEED study in BPD continuing to recruit
– Phase 1 Nav1.7 & Kv7 studies underway
– Tucker Kelly appointed as Chief Financial Officer, bringing extensive strategic commercial finance experience in anticipation of the azetukalner launch
– Conference call at 4:30 pm ET today
VANCOUVER, BC and BOSTON, MA, November 3, 2025 – 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, 2025 and provided a business update.
“We are entering an important, catalyst-rich period for Xenon. We recently completed randomization of 380 patients in our Phase 3 X-TOLE2 study of azetukalner in FOS, with topline data expected in early 2026,” said Ian Mortimer, President and Chief Executive Officer of Xenon. “We continue to explore broadening the use of azetukalner with our Phase 3 neuropsychiatry studies, including our Phase 3 X-NOVA2 and X-NOVA3 studies in major depressive disorder and the X-CEED study in bipolar depression. With our earlier stage programs, we continue to make good progress in our two first-in-human Phase 1 studies for our lead molecules in our Nav1.7 and Kv7 pain programs.”
Business Highlights and Anticipated Milestones
Azetukalner Clinical Development
Azetukalner, a novel, highly potent, selective 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
Neuropsychiatric Programs
Early-Stage Pipeline: Next-Generation Ion Channel Modulators
Xenon continues to expand its portfolio of innovative potential medicines using its expertise in discovering and developing potassium and sodium channel modulators.
Partnered Program
Corporate
Third Quarter Financial Results
Conference Call Information
Xenon will host a conference call and webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss its third quarter 2025 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 3971394.
Phase 3 Epilepsy Program
Xenon’s Phase 3 epilepsy program includes three Phase 3 clinical studies in focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS). Designed closely after the Phase 2b X-TOLE clinical study, the Phase 3 X-TOLE clinical studies are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered orally with food as adjunctive treatment in approximately 360 patients with FOS per study. The primary efficacy endpoint is the median percent change (MPC) in monthly seizure frequency from baseline through the 12-week double-blind period (DBP) of azetukalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study evaluating the clinical efficacy, safety, and tolerability of 25 mg of azetukalner administered with food as adjunctive treatment in approximately 160 patients with PGTCS. The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the 12-week DBP of azetukalner compared to placebo. Upon completion of the DBP in the Phase 3 epilepsy studies, eligible patients may enter an open-label extension (OLE) study for up to three years.
Phase 3 MDD Program
Xenon’s Phase 3 X-NOVA major depressive disorder (MDD) program includes three multicenter, randomized, double-blind, placebo-controlled clinical studies to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 450 patients with moderate-to-severe major depressive disorder (MDD) per study. The primary efficacy endpoint is the change from baseline in the HAM-D17 score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an open-label extension (OLE) study for up to 12 months.
Phase 3 BPD Program
Xenon’s Phase 3 X-CEED Bipolar Depression (BPD) program includes two multicenter, randomized, double-blind, placebo-controlled clinical studies to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 400 patients per study with BPD I or II. The primary efficacy endpoint is the change from baseline in the MADRS score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an open-label extension (OLE) study for up to 12 months.
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, selective Kv7 potassium channel opener in Phase 3 clinical studies 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 Nav1.7 and Kv7 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.
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; 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.
“Xenon” and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.
Contact:
Colleen Alabiso
Senior Vice President, Corporate Affairs
(617) 671-9238
Media: media@xenon-pharma.com
Investors: investors@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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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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$ |
462,268 |
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$ |
626,905 |
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Other current assets |
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17,869 |
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8,359 |
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Marketable securities, long-term |
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92,988 |
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127,496 |
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Other long-term assets |
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34,711 |
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35,379 |
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Total assets |
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$ |
607,836 |
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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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$ |
36,840 |
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$ |
34,221 |
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Other current liabilities |
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1,495 |
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1,369 |
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Other long-term liabilities |
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9,990 |
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7,646 |
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Total liabilities |
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$ |
48,325 |
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$ |
43,236 |
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Shareholders’ equity |
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$ |
559,511 |
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$ |
754,903 |
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Total liabilities and shareholders’ equity |
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$ |
607,836 |
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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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Nine Months 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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77,054 |
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56,970 |
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213,239 |
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150,922 |
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General and administrative |
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19,282 |
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16,706 |
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57,564 |
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50,899 |
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Total operating expenses |
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96,336 |
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73,676 |
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270,803 |
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201,821 |
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Loss from operations |
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(96,336 |
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(73,676 |
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(263,303 |
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(201,821 |
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Other income |
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6,117 |
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10,566 |
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23,132 |
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32,935 |
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Loss before income taxes |
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(90,219 |
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(63,110 |
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(240,171 |
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(168,886 |
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Income tax recovery (expense) |
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(677 |
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320 |
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(478 |
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241 |
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Net loss |
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$ |
(90,896 |
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$ |
(62,790 |
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$ |
(240,649 |
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$ |
(168,645 |
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Other comprehensive income: |
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Unrealized gain on available-for-sale securities |
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364 |
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3,548 |
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2,089 |
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1,413 |
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Comprehensive loss |
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$ |
(90,532 |
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$ |
(59,242 |
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$ |
(238,560 |
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$ |
(167,232 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(1.15 |
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$ |
(0.81 |
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$ |
(3.05 |
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$ |
(2.17 |
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Weighted average common shares outstanding: |
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Basic and diluted |
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79,247,976 |
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77,926,205 |
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78,962,975 |
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77,730,644 |
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