VANCOUVER, British Columbia and BOSTON, Jan. 07, 2025 (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 that the company will present at the 43rd Annual J.P. Morgan Healthcare Conference taking place in San Francisco, CA from January 13-16, 2025. Company Presentation Details: Date:Monday, January 13, 2025Time:9:45-10:25 AM Pacific ...

It has been about a month since the last earnings report for Xenon Pharmaceuticals (XENE) . Shares have added about 2.4% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Xenon Pharmaceuticals due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Xenon Q3 Loss Narrower Th ...

VANCOUVER, British Columbia and BOSTON, Nov. 13, 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 that the Company will present at two upcoming investor conferences. Stifel 2024 Healthcare Conference on Monday, November 18, 2024 at 9:10 a.m. ET (webcast link)Jefferies London Healthcare Conference 2024 on Wednesday, November ...

Xenon Pharmaceuticals Inc. (XENE) reported a loss of 81 cents per share for the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 82 cents. The company had incurred a loss of 73 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 ...

Financial Performance - Cash and cash equivalents and marketable securities were $803.3 million as of September 30, 2024, down from $930.9 million as of December 31, 2023[9] - Net loss for Q3 2024 was $62.8 million, compared to a net loss of $48.5 million in Q3 2023, driven by higher R&D expenses and personnel costs[9] - The comprehensive loss for Q3 2024 was $59,242,000, compared to a comprehensive loss of $48,116,000 in Q3 2023, reflecting a 23.1% increase[15] - Basic and diluted net loss per common share was $(0.81) in Q3 2024, compared to $(0.73) in Q3 2023, representing an increase in loss per share[15] - Loss from operations for the nine months ended September 30, 2024, was $(201,821,000), compared to $(160,359,000) for the same period in 2023, a 25.9% increase[15] Research and Development - Research and development expenses for Q3 2024 were $57.0 million, an increase of $14.1 million compared to $42.9 million in Q3 2023, primarily due to azetukalner Phase 3 clinical trials[9] - Research and development expenses increased to $56,970,000 in Q3 2024 from $42,880,000 in Q3 2023, representing a 32.5% increase[15] - Multiple candidates targeting Kv7, Nav1.7, and Nav1.1 are advancing towards IND filings in 2025[6] - Azetukalner has shown compelling double-blind efficacy data, believed to demonstrate the best placebo-adjusted results in focal onset seizure patients[1] - The company has generated over 600 patient-years of exposure data supporting azetukalner's efficacy and safety profile[4] - The first topline data readout from the Phase 3 X-TOLE2 study for focal onset seizures is anticipated in the second half of 2025[3] - The first Phase 3 trial in major depressive disorder (MDD), X-NOVA2, is expected to initiate by year-end 2024[5] Administrative Expenses - General and administrative expenses for Q3 2024 were $16.7 million, up from $12.8 million in Q3 2023, reflecting increased personnel-related costs[9] - General and administrative expenses rose to $16,706,000 in Q3 2024 compared to $12,804,000 in Q3 2023, marking a 30.5% increase[15] Other Financial Metrics - Other income for Q3 2024 was $10,566,000, up from $7,065,000 in Q3 2023, which is a 49.5% increase[15] - Income tax recovery for Q3 2024 was $320,000, compared to $157,000 in Q3 2023, showing a 103.2% increase[15] - Unrealized gain on available-for-sale securities was $3,548,000 in Q3 2024, up from $346,000 in Q3 2023, indicating a significant increase[15] Executive Changes - The company appointed Matt Ronsheim as Chief Operating Officer, enhancing its senior executive team[7] Shareholder Information - Weighted-average common shares outstanding increased to 77,926,205 in Q3 2024 from 66,002,163 in Q3 2023, a growth of 18%[15]

– Phase 3 epilepsy program advancing with X-TOLE2 topline FOS data anticipated in H2 2025 – Long-term azetukalner results from X-TOLE open-label extension study in FOS to be presented at AES – Phase 3 MDD program on track with X-NOVA2 study expected to initiate by year-end – Expanding ion channel portfolio includes multiple candidates advancing towards IND filings in 2025 – Recent appointment of Matt Ronsheim, experienced pharmaceutical executive joining Xenon’s senior executive team as Chief Operating Offi ...

VANCOUVER, British Columbia and BOSTON, Nov. 05, 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 third quarter 2024 financial results after the close of U.S. financial markets on Tuesday, November 12, 2024. Conference Call/Webcast Information: Date: Tuesday, November 12, 2024  Time:4:30 pm Eastern Time (1 ...

Core Insights - Xenon Pharmaceuticals presented three posters at the 15th European Epilepsy Congress, showcasing long-term data and improved quality of life outcomes for adults with focal onset seizures treated with azetukalner, a novel Kv7 channel opener [1][2] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to developing therapeutics for neurological and psychiatric disorders, with a focus on high unmet medical needs such as epilepsy and depression [4] Clinical Data - Azetukalner is the only Kv7 potassium channel opener in clinical development supported by Phase 2b data, demonstrating over 90% reduction in median monthly seizure frequency for patients in the open-label extension study [2][5] - Approximately 25% of patients on azetukalner for at least two years experienced a year or longer of seizure freedom [2] Presentations at EEC - Poster P282: Interim data from the ongoing X-TOLE study in adults with focal onset seizures [3] - Poster P281: Improvements in quality of life for adults with focal onset seizures treated with azetukalner [3] - Poster P406: Non-seizure symptoms, mental health comorbidities, and quality of life in patients with focal onset seizures [3] Ongoing Clinical Trials - Xenon's Phase 3 epilepsy program includes three ongoing trials for focal onset seizures and primary generalized tonic-clonic seizures, evaluating the efficacy and safety of azetukalner [5]

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]