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Xenon Pharmaceuticals Inc.

For the period ended Jun 30, 2026. Filed Aug 6, 2026.

View on SEC.gov

About 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, 2026 · Filed Aug 6, 2026

XENE$39.17+4.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001193125-26-212153

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-06.

0001193125-26-338244

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 134 previous paragraphs and 134 current paragraphs.

104 unchanged; 21 reworded; 9 added; 9 removed; 0 previous and 0 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 (9)

Current report

We remain on track to submit our New Drug Application (NDA) for azetukalner in FOS in the third quarter of 2026, having completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA).

Current report

We recently received approval of our Clinical Trial Application (CTA) to initiate a Phase 1 study of XEN1720 targeting Nav1.7. The Phase 1 SAD/MAD study in healthy adult participants is now underway.

Current report

Beyond azetukalner, we are committed to advancing additional novel treatment approaches to address significant unmet needs in epilepsy.

Current report

Comparison of three and six months ended June 30, 2026 and 2025
Removed paragraphs (9)

Previous report

We announced positive topline data from the Phase 3 X-TOLE2 study in March 2026. The study met its primary endpoint of median percent change (MPC) in monthly FOS frequency from baseline to week 12 in both the 25 mg and 15 mg azetukalner dose groups compared to placebo (MPC of -53.2%, -34.5% and -10.4%, respectively; p<0.0001 for both 25 and 15 mg vs. placebo). The placebo-adjusted MPC in the 25 mg group was -42.7%, outperforming the previously completed Phase 2b X-TOLE study and demonstrating the highest placebo-adjusted efficacy ever observed in a pivotal FOS study, to our knowledge. The safety and tolerability profile of azetukalner was consistent with the previously disclosed data from the Phase 2b X-TOLE study. Based on the positive results from X-TOLE2 and X-TOLE, we anticipate submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2026.

Previous report

X-TOLE2 topline efficacy and safety results were featured as a Late Breaking Science oral and poster presentation at the American Academy of Neurology (AAN) Annual Meeting in Chicago, Illinois, April 18-22. Also at AAN, we presented 48-month data from the ongoing X-TOLE open-label extension study, which demonstrated continued reductions in monthly FOS frequency with longer azetukalner treatment, greater seizure reductions in less refractory patients, and sustained periods of seizure freedom. We also presented real-world data regarding unmet needs in epilepsy, including the need for no-titration options.

Previous report

We presented pre-clinical data for our Nav1.1 program in an oral session at the AAN meeting, demonstrating that selective potentiation of Nav1.1 channels in Dravet mice improves motor performance, suppresses spontaneous seizures, prevents Sudden Unexpected Death in Epilepsy (SUDEP), increases long-term potentiation (a potential cellular correlate of learning and memory), and produces more mature dendritic spine morphology.
Reworded paragraphs (21)

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 for patients in need.

Previous wording

Azetukalner is a novel, potent Kv7 potassium channel opener in Phase 3 clinical development for 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).

Current wording

Azetukalner is a novel, potent Kv7 potassium channel opener in late-stage development for multiple potential 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).

Previous wording

The Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside the United States. X-TOLE3 enrollment outside of Japan is expected to complete in 2026.

Current wording

The Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside of the United States. X-TOLE3 enrollment outside of Japan is expected to complete in 2026.

Previous wording

Enrollment is ongoing for the Phase 3 X-NOVA2 and X-NOVA3 studies evaluating azetukalner in patients with MDD, with topline data from X-NOVA2 expected in H1 2027.

Current wording

Enrollment is ongoing in the Phase 3 X-NOVA2 and X-NOVA3 studies evaluating azetukalner in patients with MDD, with topline data from X-NOVA2 expected in H1 2027.

Previous wording

We continue to expand our portfolio of potent, selective ion channel modulators using our 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 targets for pain.

Current wording

We continue to expand our portfolio of potent, selective ion channel modulators using our 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 pain.

Previous wording

IND-enabling studies are ongoing for our Nav1.1 program. Pre-clinical data suggest that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet syndrome.

Current wording

IND-enabling studies are ongoing for our oral small molecule Nav1.1 program. Pre-clinical data suggest that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet syndrome.

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, 2026 and 2025, we recognized revenue of nil and $7.5 million, 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, 2026 and 2025, we recognized revenue of nil and $7.5 million, 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 $102.3 million and $65.0 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $1,347.7 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 $213.0 million and $149.8 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $1,458.4 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

Foreign exchange gain. Foreign exchange gain consists of gains from the impact of foreign exchange fluctuations on our monetary assets and liabilities that are denominated in currencies other than the U.S. dollar (principally the Canadian dollar). We will continue to incur substantial expenses in Canadian dollars and will remain subject to risks associated with foreign currency fluctuations.

Current wording

Foreign exchange gain (loss). Foreign exchange gain (loss) consists of gains and losses from the impact of foreign exchange fluctuations on our monetary assets and liabilities that are denominated in currencies other than the U.S. dollar (principally the Canadian dollar). We will continue to incur substantial expenses in Canadian dollars and will remain subject to risks associated with foreign currency fluctuations.

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, 2026, 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 2025 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 26, 2026. 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, 2026, 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 2025 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 26, 2026. 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

We did not recognize any revenue during the three months ended March 31, 2026. 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.

Current wording

We did not recognize any revenue during the six months ended June 30, 2026. 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.

Previous wording

Direct external costs related to azetukalner increased by $15.6 million for the three months ended March 31, 2026, primarily due to our ongoing Phase 3 clinical studies in the MDD and BPD programs. Pain programs costs increased by $3.3 million due to our ongoing Phase 1 clinical studies of XEN1701 and XEN1120. Personnel-related costs increased by $8.6 million due to higher headcount to support late-stage development.

Current wording

Direct external costs related to azetukalner increased by $12.4 million and $27.9 million for the three months and six months ended June 30, 2026, respectively, primarily due to our ongoing Phase 3 clinical studies in the MDD and BPD programs, as well as manufacturing activities to support our planned NDA submission. Pain programs costs increased by $4.7 million and $8.0 million for the three months and six months ended June 30, 2026, respectively, primarily due to our ongoing Phase 1 clinical studies of XEN1701 and XEN1120, as well as manufacturing activities to support the clinical studies. Personnel-related costs increased by $5.7 million and $14.3 million for the three months and six months ended June 30, 2026, respectively, due to higher headcount supporting our late-stage product candidate development and an increase in stock-based compensation.

Previous wording

Personnel-related costs increased by $2.5 million for the three months ended March 31, 2026, primarily due to higher headcount to support our expanding research and development activities and future potential commercialization. Professional and consulting fees increased by $1.8 million due to an increase in pre-commercial expenses and higher expenses related to maintenance and filing of intellectual property.

Current wording

Personnel-related costs increased by $2.7 million and $5.2 million for the three months and six months ended June 30, 2026, respectively, primarily due to higher headcount to support our expanding research and development activities and future potential commercialization as well as an increase in stock-based compensation expense. Professional and consulting fees increased by $1.6 million and $3.4 million for the three months and six months ended June 30, 2026, respectively, due to an increase in pre-commercial expenses and higher expenses related to maintenance and filing of intellectual property.

Previous wording

Interest income decreased by $1.2 million for the three months ended March 31, 2026, driven by lower average market yields on investments, partially offset by a higher average balance of cash and cash equivalents and marketable securities.

Current wording

Interest income increased by $4.9 million and $3.8 million for the three and six months ended June 30, 2026, respectively, due to a higher average balance of cash and cash equivalents and marketable securities, partially offset by lower average market yields on investments. The foreign exchange gain decreased by $2.0 million and $1.5 million for the three and six months ended June 30, 2026, respectively, due to fluctuations in the value of the Canadian dollar, partially offset by a lower balance of cash and cash equivalents and marketable securities denominated in Canadian dollars.

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, 2026, we have raised aggregate net cash proceeds of approximately $2.3 billion primarily from the issuance of equity securities. As of March 31, 2026, we had cash and cash equivalents and marketable securities of $1,339.6 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, 2026, we have raised aggregate net cash proceeds of approximately $2.3 billion primarily from the issuance of equity securities. As of June 30, 2026, we had cash and cash equivalents and marketable securities of $1,245.1 million.

Previous wording

We entered into an “at-the-market” equity offering sales agreement, amended as of March 2022, with Jefferies LLC and Stifel, Nicolaus & Company, Incorporated, pursuant to which we may sell common shares from time to time (the “ATM Program”). Pursuant to a prior prospectus, we sold an aggregate of 3,134,119 common shares for proceeds of $130.0 million, net of commissions and transaction expenses, during the period from January 1, 2026 to February 26, 2026. On February 27, 2026, a new prospectus supplement was filed replacing the prior prospectus, pursuant to which we refreshed the ATM Program and may sell common shares having gross proceeds of up to $400.0 million, from time to time.

Current wording

We entered into an “at-the-market” equity offering sales agreement, amended as of March 2022, with Jefferies LLC and Stifel, Nicolaus & Company, Incorporated, pursuant to which we may sell common shares from time to time (the “ATM Program”). During the period from January 1, 2026 to February 26, 2026, we sold an aggregate of 3,134,119 common shares under the ATM Program for proceeds of $130.0 million, net of commissions and transaction expenses. On February 27, 2026, we refreshed the ATM Program by filing a new prospectus supplement, pursuant to which we may sell common shares having gross proceeds of up to $400.0 million, from time to time.

Previous wording

We have incurred significant operating losses since inception. As of March 31, 2026, we had an accumulated deficit of $1,347.7 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, 2026, we had an accumulated deficit of $1,458.4 million. We expect to incur operating losses that may fluctuate significantly from quarter to quarter and year to year over the next several years. In addition, we expect to continue to incur significant expenses in excess of our revenue 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, 2026 and 2025 (in thousands):

Current wording

The following table shows a summary of our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

Previous wording

For the three months ended March 31, 2026, net cash used in operating activities totaled $88.9 million, compared to $61.7 million for the same period in 2025. The increase in cash used in operating activities was primarily driven by higher research and development and general and administrative expenses and no revenue recognized in the period ended March 31, 2026, lower interest income, partially offset by changes in operating assets and liabilities.

Current wording

For the six months ended June 30, 2026, net cash used in operating activities totaled $184.3 million, compared to $125.9 million for the same period in 2025. The increase in cash used in operating activities was primarily driven by higher research and development and general and administrative expenses, no revenue recognized in the six months ended June 30, 2026, lower cash received from interest income, and changes in operating assets and liabilities.

Previous wording

For the three months ended March 31, 2026, net cash used in investing activities totaled $407.3 million, compared to net cash provided of $34.5 million for the same period in 2025. The change was driven primarily by an increase in the purchase of marketable securities, net of redemptions.

Current wording

For the six months ended June 30, 2026, net cash used in investing activities totaled $738.5 million, compared to net cash provided of $116.8 million for the same period in 2025. The change was driven primarily by an increase in the purchase of marketable securities, net of redemptions.

Previous wording

For the three months ended March 31, 2026, net cash provided by financing activities was $843.0 million, compared to $1.2 million for the same period in 2025. The increase was primarily related to $837.5 million net proceeds from offerings, as well as an increase in proceeds from stock option exercises.

Current wording

For the six months ended June 30, 2026, net cash provided by financing activities was $843.0 million, compared to $1.2 million for the same period in 2025. The increase was primarily related to $837.5 million net proceeds from offerings, as well as an increase in proceeds from stock option exercises.