Xenon Pharmaceuticals Inc.
For the period ended Jun 30, 2025. Filed Aug 11, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 11, 2025
XENE$39.17+4.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0000950170-25-069342
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0000950170-25-106599
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 132 previous paragraphs and 132 current paragraphs.
102 unchanged; 24 reworded; 5 added; 6 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
the impact of current and future healthcare reforms, including those affecting the delivery of or payment for healthcare products and services;
Current report
Phase 3 X-TOLE2 clinical study of azetukalner in FOS has now completed patient recruitment, with topline data anticipated in early 2026.
Current report
X-CEED, the first of two planned Phase 3 clinical studies evaluating azetukalner in patients with BPD I and BPD II depression, has been initiated. Our Phase 3 BPD program includes two multicenter, randomized, double-blind, placebo-controlled clinical trials to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period, or DBP, as monotherapy treatment in approximately 400 patients per study with BPD I or BPD 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, or OLE, study for up to 12 months.
Current report
Comparison of three and six months ended June 30, 2025 and 2024
Current report
Interest income decreased by $3.6 million and $6.9 million for the three and six months ended June 30, 2025, respectively, due to a lower average balance of marketable securities as well as lower average market yields on investments. The increase in foreign exchange gains of $1.7 million and $1.6 million for the three and six months ended June 30, 2025, respectively, was due to fluctuations in the value of the Canadian dollar and a higher balance of cash and cash equivalents denominated in Canadian dollars.
Removed paragraphs (6)
Previous report
Phase 3 X-TOLE2/3 azetukalner clinical studies in FOS continue to advance, with the first topline data readout anticipated in early 2026.
Previous report
We presented at the American Academy of Neurology Annual Meeting, including 36-month data from the ongoing X-TOLE open-label extension study of azetukalner in patients with FOS, which demonstrated sustained monthly reduction in seizure frequency, impressive seizure freedom rates, and a consistent AE profile suggesting long-term efficacy and tolerability of azetukalner.
Previous report
We announced plans for a Phase 3 BPD program earlier this year, with initiation of the first azetukalner clinical study in BPD I and BPD II depression expected by mid-year.
Previous report
The investigator-sponsored Phase 2 proof-of-concept study of azetukalner in MDD led by Icahn School of Medicine at Mount Sinai did not meet its primary neuroimaging endpoint. Compared to placebo, azetukalner demonstrated drug activity and was associated with a numerically higher improvement in MADRS and SHAPS scores across all time periods measured, consistent with results seen in our Phase 2 X-NOVA study. Azetukalner was generally well tolerated, with a low rate of treatment discontinuations due to adverse events, or AEs, one serious adverse event deemed unrelated to study drug, and an AE profile consistent with prior studies and the known mechanism.
Previous report
Comparison of three months ended March 31, 2025 and 2024
Previous report
Other income decreased by $3.4 million in the three months ended March 31, 2025 as compared to the same period in 2024. The decrease was primarily attributable to a decrease in interest income in 2025 driven by a lower average balance of marketable securities as well as lower average market yields on investments.
Reworded paragraphs (24)
Previous wording
We are a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics. We are advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression.
Current wording
We are a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics. We are advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression.
Previous wording
Phase 3 X-ACKT clinical study continues to enroll patients and is intended to support potential regulatory submissions in an additional epilepsy indication of PGTCS.
Current wording
Phase 3 X-ACKT clinical study of azetukalner in PGTCS continues to enroll patients and is intended to support regulatory submissions for an additional epilepsy indication.
Previous wording
X-NOVA2, the first of three planned Phase 3 clinical trials evaluating azetukalner in patients with MDD is currently enrolling patients, and X-NOVA3 is expected to initiate mid-year.
Current wording
X-NOVA2 and X-NOVA3, the first two of three planned Phase 3 clinical trials evaluating azetukalner in patients with MDD, are now underway and screening patients.
Previous wording
A Clinical Trial Application was recently accepted for XEN1120, a Kv7 channel opener, with a Phase 1 study in healthy adult participants now underway. Work remains ongoing with additional Kv7 development molecules and chemistries. Kv7 may have utility in a broad range of therapeutic indications including seizure disorders, pain, and neuropsychiatric disorders, such as MDD and BPD.
Current wording
Phase 1 study in healthy adult participants is underway for XEN1120, a Kv7 channel opener in development for pain. Work remains ongoing with additional Kv7 development molecules and chemistries with the hypothesis that Kv7 may have utility in a broad range of therapeutic indications including seizure disorders, pain, and neuropsychiatric disorders, such as MDD and BPD.
Previous wording
IND-enabling work is underway with multiple Nav1.7 development candidates, with an IND (or equivalent) filing and Phase 1 study initiation for our lead candidate, XEN1701, expected in the third quarter. Nav1.7 is an important pain-related target, based on strong human genetic validation, that may represent a new class of medicines without the limitations of opioids.
Current wording
Phase 1 study was initiated for XEN1701, our lead Nav1.7 development candidate for pain. IND-enabling work remains ongoing for additional Nav1.7 candidates. Nav1.7 is an important pain-related target, based on strong human genetic validation, which may represent a new class of medicines without the limitations of opioids.
Previous wording
We expect a lead candidate within its Nav1.1 program to enter IND-enabling studies in 2025. Pre-clinical data suggests that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet Syndrome.
Current wording
Nav1.1 lead candidate is expected to enter IND-enabling studies in 2025, with pre-clinical data suggesting that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet Syndrome.
Previous wording
As part of our ongoing collaboration with Neurocrine Biosciences, a Phase 1 study is underway of NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 in development for the potential treatment of certain types of epilepsy.
Current wording
As part of Xenon’s ongoing collaboration with Neurocrine Biosciences, a Phase 1 study is underway for NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 in development for the potential treatment of certain types of epilepsy.
Previous wording
We have funded our operations primarily through the sale of equity securities, funding received from our licensees and collaborators, and debt financing. For the three months ended March 31, 2025 and 2024, we recognized revenue of $7.5 million and nil, respectively, in connection with our agreement with Neurocrine Biosciences. To date, we have not had any products approved for sale and have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for a product candidate, which we expect will take a number of years, if ever, and the outcome of which is subject to significant uncertainty.
Current wording
We have funded our operations primarily through the sale of equity securities, funding received from our licensees and collaborators, and debt financing. For the six months ended June 30, 2025 and 2024, we recognized revenue of $7.5 million and nil, respectively, in connection with our agreement with Neurocrine Biosciences. To date, we have not had any products approved for sale and have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for a product candidate, which we expect will take a number of years, if ever, and the outcome of which is subject to significant uncertainty.
Previous wording
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We have incurred net losses in each year since inception and expect to continue to incur net losses for the foreseeable future. We had a net loss of $65.0 million and $47.9 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $964.5 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We anticipate that our operating expenses will increase substantially, particularly as we:
Current wording
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We have incurred net losses in each year since inception and expect to continue to incur net losses for the foreseeable future. We had a net loss of $149.8 million and $105.9 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $1,049.2 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We anticipate that our operating expenses will increase substantially, particularly as we:
Previous wording
There have been no material changes in our critical accounting policies and significant judgments and estimates during the three months ended March 31, 2025, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Conditions and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates” included in our 2024 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or SEC, and with the securities commissions in British Columbia, Alberta and Ontario, or the Canadian Securities Commissions, on February 27, 2025. We believe that the accounting policies discussed in the Annual Report are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Current wording
There have been no material changes in our critical accounting policies and significant judgments and estimates during the six months ended June 30, 2025, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Conditions and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates” included in our 2024 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or SEC, and with the securities commissions in British Columbia, Alberta and Ontario, or the Canadian Securities Commissions, on February 27, 2025. We believe that the accounting policies discussed in the Annual Report are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Previous wording
The following table summarizes the results of our operations for the three months ended March 31, 2025 and 2024 together with changes in those items (in thousands):
Current wording
The following table summarizes the results of our operations for the three and six months ended June 30, 2025 and 2024 together with changes in those items (in thousands):
Previous wording
Collaboration revenue of $7.5 million recognized during the three months ended March 31, 2025 was related to a milestone payment in connection with the Neurocrine Collaboration. We did not recognize any revenue for the same period in 2024.
Current wording
Collaboration revenue of $7.5 million recognized during the six months ended June 30, 2025 was related to a milestone payment in connection with the Neurocrine Collaboration. We did not recognize any revenue for the same period in 2024.
Previous wording
The following table summarizes research and development expenses for the three months ended March 31, 2025 and 2024 together with changes in those items (in thousands):
Current wording
The following table summarizes research and development expenses for the three and six months ended June 30, 2025 and 2024 together with changes in those items (in thousands):
Previous wording
Research and development expenses increased by $17.0 million in the three months ended March 31, 2025 as compared to the same period in 2024. Direct external costs related to azetukalner increased by $8.3 million primarily due to our Phase 3 epilepsy clinical trials and our Phase 3 X-NOVA2 clinical trial in MDD which initiated in late 2024. Personnel-related costs increased by $6.9 million driven by an increase in headcount to support late-stage development. Pre-clinical and discovery program costs increased by $1.3 million due to the advancement of multiple potential drug candidates targeting Kv7, Nav1.7 and Nav1.1.
Current wording
Direct external costs related to azetukalner increased by $20.1 million and $28.3 million for the three and six months ended June 30, 2025, respectively, primarily due to our ongoing Phase 3 clinical trials in epilepsy and MDD, as well as start-up costs for our Phase 3 BPD program. Pre-clinical, discovery and other program costs increased by $1.2 million for the six months ended June 30, 2025 due to the advancement of XEN1120 and other potential drug candidates targeting Kv7, Nav1.7 and Nav1.1. Personnel-related costs increased by $5.8 million and $12.8 million for the three and six months ended June 30, 2025, respectively, due to higher headcount to support late-stage development.
Previous wording
The following table summarizes general and administrative expenses for the three months ended March 31, 2025 and 2024 together with changes in those items (in thousands):
Current wording
The following table summarizes general and administrative expenses for the three and six months ended June 30, 2025 and 2024 together with changes in those items (in thousands):
Previous wording
General and administrative expenses increased by $4.2 million in the three months ended March 31, 2025 as compared to the same period in 2024. The increase was primarily attributable to personnel-related costs due to increased headcount to support our expanding research and development activities and future potential commercialization.
Current wording
Personnel-related costs increased by $3.1 million for the six months ended June 30, 2025 primarily due to higher headcount to support our expanding research and development activities and future potential commercialization.
Previous wording
The following table summarizes our other income for the three months ended March 31, 2025 and 2024 together with changes in those items (in thousands):
Current wording
The following table summarizes our other income for the three and six months ended June 30, 2025 and 2024 together with changes in those items (in thousands):
Previous wording
To date, we have financed our operations primarily through the sale of equity securities, funding received from collaboration and license agreements, and debt financing. Since our initial public offering through March 31, 2025, we have raised aggregate net cash proceeds of more than $1.4 billion primarily from the issuance of equity securities. As of March 31, 2025, we had cash and cash equivalents and marketable securities of $691.1 million.
Current wording
To date, we have financed our operations primarily through the sale of equity securities, funding received from collaboration and license agreements, and debt financing. Since our initial public offering through June 30, 2025, we have raised aggregate net cash proceeds of more than $1.4 billion primarily from the issuance of equity securities. As of June 30, 2025, we had cash and cash equivalents and marketable securities of $624.8 million.
Previous wording
We have incurred significant operating losses since inception. As of March 31, 2025, we had an accumulated deficit of $964.5 million. We expect to continue to incur significant expenses in excess of our revenue and expect to incur operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year. We expect to incur significant expenses and increasing operating losses for the foreseeable future as we prepare for the potential commercial launch of azetukalner; invest significantly to further develop azetukalner for our current and future indications; advance additional product candidates into pre-clinical and clinical development; seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical studies; manufacture larger quantities of our product candidates of clinical development and potential commercialization; hire additional commercial, clinical, scientific, management and administrative personnel; acquire or in-license other product candidates and technologies; make milestone or other payments under our in-license or other agreements, including, without limitation, payments to 1st Order Pharmaceuticals, Inc and other third parties; maintain, protect and expand our intellectual property portfolio; establish a sales, marketing, distribution and other commercial infrastructure to commercialize any products for which we may obtain marketing approval; create additional infrastructure and incur additional costs to support our operations and our product development and planned future commercialization efforts; and experience any delays or encounter issues with any of the above.
Current wording
We have incurred significant operating losses since inception. As of June 30, 2025, we had an accumulated deficit of $1,049.2 million. We expect to continue to incur significant expenses in excess of our revenue and expect to incur operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year. We expect to incur significant expenses and increasing operating losses for the foreseeable future as we prepare for the potential commercial launch of azetukalner; invest significantly to further develop azetukalner for our current and future indications; advance additional product candidates into pre-clinical and clinical development; seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical studies; manufacture larger quantities of our product candidates of clinical development and potential commercialization; hire additional commercial, clinical, scientific, management and administrative personnel; acquire or in-license other product candidates and technologies; make milestone or other payments under our in-license or other agreements, including, without limitation, payments to 1st Order Pharmaceuticals, Inc and other third parties; maintain, protect and expand our intellectual property portfolio; establish a sales, marketing, distribution and other commercial infrastructure to commercialize any products for which we may obtain marketing approval; create additional infrastructure and incur additional costs to support our operations and our product development and planned future commercialization efforts; and experience any delays or encounter issues with any of the above.
Previous wording
The following table shows a summary of our cash flows for the three months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following table shows a summary of our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
For the three months ended March 31, 2025, net cash used in operating activities totaled $61.7 million, compared to $46.2 million for the same period in 2024. The increase in cash used in operating activities was primarily related to higher research and development and general and administrative expenses, as well as changes in operating assets and liabilities, partially offset by an increase in interest cash received on marketable securities.
Current wording
For the six months ended June 30, 2025, net cash used in operating activities totaled $125.9 million, compared to $77.3 million for the same period in 2024. The increase in cash used in operating activities was primarily driven by higher research and development and general and administrative expenses, as well as changes in operating assets and liabilities, partially offset by revenue recognized in connection with our collaboration agreement with Neurocrine Biosciences during the six months ended June 30, 2025.
Previous wording
For the three months ended March 31, 2025, net cash provided by investing activities totaled $34.5 million, compared to net cash used of $43.2 million for the same period in 2024. The change was driven primarily by an increase in the redemption of marketable securities, net of purchases.
Current wording
For the six months ended June 30, 2025, net cash provided by investing activities totaled $116.8 million, compared to $66.0 million for the same period in 2024. The change was driven primarily by a decrease in the purchase of marketable securities, net of redemption.
Previous wording
For the three months ended March 31, 2025, net cash provided by financing activities was $1.2 million, compared to nil for the same period in 2024. The change was primarily driven by proceeds from stock options exercises during the three months ended March 31, 2025.
Current wording
For the six months ended June 30, 2025, net cash provided by financing activities was $1.2 million, compared to nil for the same period in 2024. The change was primarily driven by proceeds from stock option exercises during the six months ended June 30, 2025.
Previous wording
As of May 8, 2025, we had 76,733,599 common shares issued and outstanding, outstanding pre-funded warrants to purchase 2,173,081 common shares, outstanding stock options to purchase 11,902,727 common shares, outstanding performance share units convertible into 269,350 common shares, outstanding restricted share units convertible into 301,867 common shares, and an outstanding warrant to purchase 40,000 common shares.
Current wording
As of August 7, 2025, we had 77,105,799 common shares issued and outstanding, outstanding pre-funded warrants to purchase 2,173,081 common shares, outstanding stock options to purchase 11,214,622 common shares, outstanding performance share units convertible into 275,550 common shares, outstanding restricted share units convertible into 316,057 common shares, and an outstanding warrant to purchase 40,000 common shares.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Phase 3 X-TOLE3 clinical study of azetukalner in FOS continues to enroll patients and is intended to support potential regulatory submissions in ex-U.S. jurisdictions.