Three presentations highlighting long-term data and improved quality of life outcomes in adults with focal onset seizures VANCOUVER, British Columbia and BOSTON, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced three poster presentations at the 15th European Epilepsy Congress (EEC) taking place in Rome, Italy. Azetu ...

Xenon Pharmaceuticals (XENE) is a clinical-stage biotech developing innovative therapies for neurology indications with a focus on epilepsy. At present, the company has no marketed drug in its portfolio. Xenon's pipeline comprises its lead product candidate, azetukalner, a differentiated Kv7 potassium channel, which is being developed for treating epilepsy and other neurological disorders, including major depressive disorder (MDD). Azetukalner is currently undergoing late-stage development for treating foca ...

Financial Data and Key Metrics - Cash and cash equivalents and marketable securities were $850.6 million as of June 30, 2024, compared to $930.9 million as of December 31, 2023 [26] - The company anticipates having sufficient cash to fund operations into 2027 based on current operating plans, including the completion of the azetukalner Phase 3 epilepsy studies and supporting late-stage clinical development of azetukalner in MDD [26] Business Line Data and Key Metrics - The Phase 3 azetukalner epilepsy studies are progressing, with top-line results from X-TOLE2 in focal onset seizures anticipated in the second half of 2025 [9] - The Phase 3 MDD program for azetukalner is expected to initiate in the second half of 2024, with three Phase 3 trials planned, each involving approximately 450 subjects with moderate to severe MDD [21] - The company has nominated multiple development track candidates (DTCs) targeting potassium and sodium channels, with a lead Kv7 candidate in IND-enabling studies and a lead Nav1.7 candidate expected to enter IND-enabling studies soon [11][15] Market Data and Key Metrics - The company is focusing on expanding its leadership in the small molecule ion channel space, with a particular emphasis on potassium and sodium channels [12][14] - The company is advancing multiple Kv7 molecules to extend the reach of this mechanism to more patients in need, including those with seizure disorders, pain, and neuropsychiatric conditions [12] Company Strategy and Industry Competition - The company aims to become a fully integrated biopharmaceutical company, with a focus on advancing its pipeline of next-generation ion channel modulators [6] - The company believes azetukalner has the potential to be a best-in-class medicine, supported by its unique mechanism of action and significant clinical data generated to date [27] - The company is exploring additional clinical development opportunities for azetukalner, focusing on other neuropsychiatric indications where a scientific rationale exists [10] Management Commentary on Operating Environment and Future Outlook - The company remains focused on improving outcomes for patients in areas of high unmet medical need, particularly in epilepsy and MDD [27] - The company is encouraged by the positive response to azetukalner from physicians and key opinion leaders, and looks forward to updating on progress in the coming months [25] Other Important Information - The company has over 600 patient-years of exposure to azetukalner, with some patients on the drug for more than four years, providing confidence in its long-term safety and efficacy [8] - The company is advancing a brain-penetrant small molecule potentiator of Nav1.1 for Dravet syndrome, aiming to provide a potential disease-modifying therapy [16] Q&A Session Summary Question: Patient demographics and enrollment timeline for X-TOLE2 - The company is tracking patient demographics on a blinded basis and expects to provide more information as the study progresses [30] - Top-line data for X-TOLE2 is expected in the second half of 2025, with patient screening expected to be completed six to eight months prior [31] Question: MDD trial design and competitive landscape - The company has finalized and filed its Phase 3 MDD protocol with the FDA, with the first study expected to initiate in the second half of 2024 [21] - The company believes azetukalner's unique mechanism of action, rapid onset of effect, and favorable safety profile differentiate it from other agents in development [39] Question: Next-generation Kv7 asset and its potential - The company is advancing multiple Kv7 molecules with diverse chemistries, aiming to explore additional therapeutic indications beyond epilepsy and MDD [48] - The company is not specifically trying to improve on any one attribute of azetukalner but is focused on therapeutic diversification [49] Question: Nav1.7 development and challenges - The company has learned from previous challenges in developing Nav1.7 inhibitors, including issues with selectivity and toxicity, and is now advancing novel inhibitors with improved properties [57] - The company plans to run human clinical experiments to evaluate the clinical potential of selective Nav1.7 inhibitors [59] Question: X-ACKT study design and efficacy expectations - The X-ACKT study in primary generalized tonic-clonic seizures is powered based on previous successful studies, with the company expecting robust efficacy if the drug works [64] - The company chose the 25 mg dose for X-ACKT based on the success of higher doses in focal onset seizures [84] Question: MDD study design and data release - The company plans to stagger the initiation and data release of the three Phase 3 MDD studies, with the first study expected to start in the second half of 2024 [74] - The company will focus on the HAM-D17 scale for assessing depression in the Phase 3 studies, based on its lower variability compared to MADRS [78]

Xenon Pharmaceuticals Inc. (XENE) reported a loss of 75 cents per share for the second quarter of 2024, wider than the Zacks Consensus Estimate of a loss of 72 cents. The company had incurred a loss of 72 cents per share in the year-ago quarter. In the reported quarter, Xenon did not generate any revenues. Due to the absence of a marketed product, the company only recognizes periodic collaboration revenues in its top line from its ongoing partnership with Neurocrine Biosciences (NBIX) for XEN901, now known ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to _____ ...

Exhibit 99.1 X XENON Xenon Reports Q2 2024 Financial Results and Business Update – Phase 3 epilepsy program progressing with X-TOLE2 topline FOS data anticipated in H2 2025 – MDD program on track with Phase 3 study expected to initiate in H2 2024 – Multiple Kv7 and Nav1.7 candidates progressing towards development with INDs expected in 2025 – Conference call at 4:30 pm ET today VANCOUVER, British Columbia, August 8, 2024 – Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurosciencefocused biopharmaceutical com ...

VANCOUVER, British Columbia, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need, today announced it will report its second quarter 2024 financial and operating results after the close of U.S. financial markets on Thursday, August 8, 2024. Conference Call/Webcast Information: | --- | --- | |----------------|----------------------------- ...

Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Chad Fugere - Vice President, Investor Relations Ian Mortimer - President and CEO Dr. Chris Kenney - Chief Medical Officer Dr. Chris Von Seggern - Chief Commercial Officer Sherry Aulin - Chief Financial Officer Conference Call Participants Paul Matteis - Stifel Leo Timashev - RBC Capital Markets Jason Gerberry - Bank of America Luke Hermann - Baird Tess Romero - JPMorgan Khalil Fenina - Gold ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-36687 XENON PHARMACEUTICALS INC. (Exact name of Registrant as Specified in its Charter) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Canada 98-0661854 ...

Exhibit 99.1 NEWS RELEASE Xenon Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update Phase 3 epilepsy program continues to progress with anticipated completion of patient enrollment in X-TOLE2 in late 2024 to early 2025 Successful “end-of-Phase 2” interactions with FDA in MDD; Phase 3 program on track to initiate in the second half of the year Azetukalner now the international nonproprietary name (INN) and United States adopted name (USAN) for XEN1101 Conference call at ...