There exist opportunities in certain cases where a biotech company's lead product has undergone extensive mid-stage development and has been tested over extended periods via open-label extension trials; however, the current market price of the company doesI have a strong inclination towards high-growth companies, often treading in sectors poised for exponential expansion. My expertise lies in understanding and investing in disruptive technologies and forward-thinking enterprises. My approach is a mix of fun ...

Group 1 - There are investment opportunities in biotech companies with lead products that have undergone extensive mid-stage development and long-term testing through open-label extension trials [1] - The focus is on high-growth companies in sectors expected to experience exponential expansion, particularly those involved in disruptive technologies [1] - The investment approach combines fundamental analysis with predictions of future trends, emphasizing the potential of innovation to generate significant returns [1]

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PresentationIan MortimerPresident, CEO, Principal Accounting Officer & Director Good morning, everyone, and thank you for joining us. We're excited to be speaking with you fresh off a highly successful American Epilepsy Society Meeting for Xenon. Before we begin, please note the standard notice that we will make a number of statements today that are forward-looking. I encourage you to review our SEC filings for a more complete discussion of risks facing our business and readers are cautioned not to place un ...

Xenon Pharmaceuticals (NasdaqGM:XENE) Update / Briefing December 10, 2025 10:00 AM ET Company ParticipantsIan Mortimer - President and CEOChris Kenney - Chief Medical OfficerDarren Cline - Chief Commercial OfficerIan MortimerGood morning, everyone, and thank you for joining us. We're excited to be speaking with you fresh off a highly successful American Epilepsy Society meeting for Xenon. Before we begin, please note the standard notice that we will make a number of statements today that are forward-looking ...

Azetukalner Efficacy and Safety - Azetukalner demonstrated a 90.9% median percent change (MPC) reduction in monthly focal onset seizure (FOS) frequency after 48 months in the open-label extension (OLE) [92] - A subset of patients receiving 1-2 anti-seizure medications (ASMs) at double-blind period (DBP) baseline experienced a 100% monthly reduction in FOS frequency [92] - 38% of patients treated with azetukalner for at least 48 months achieved seizure freedom for one year or longer [92] - Azetukalner's safety and tolerability profile in the OLE remained consistent with the DBP [92, 73] - In the Phase 2b X-TOLE study, azetukalner showed statistically significant and dose-dependent seizure reduction, with up to a 52.8% median percent change from baseline [34] Commercial Opportunity and Market Insights - Xenon Pharmaceuticals has $555.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, with anticipated cash runway into 2027 [18] - An estimated 2.6 million adults in EU4 + UK, 3.0 million in Japan, and 0.8 million in the U.S have diagnosed epilepsy [95] - Focal onset seizures (FOS) represent the largest segment of the epilepsy population [95] - Up to 50% of epilepsy patients may require additional treatment options, presenting a significant commercial opportunity [102, 97] Clinical and Patient Burden - Depression is a significant burden for patients with FOS, highlighting the need for therapeutics that do not exacerbate mood disorders [92, 79] - Titration of anti-seizure medications (ASMs) poses a significant burden for both patients and healthcare professionals (HCPs), underscoring the need for simplified or no-titration ASMs [92, 87]

Core Insights - Xenon Pharmaceuticals Inc. announced new data on its commitment to epilepsy treatment, including interim 48-month data from the X-TOLE open-label extension study of azetukalner, real-world studies on depression burden, and pre-clinical data for Dravet syndrome [1][2] Group 1: Azetukalner Efficacy and Safety - The interim data from the X-TOLE study showed a monthly seizure frequency reduction of over 90% at 48 months, with a 100% reduction in patients on 1-2 anti-seizure medications (ASMs) at baseline [2][4] - Among participants treated for 48 months, 38.2% achieved at least 12 months of seizure freedom, while 10.7% maintained seizure freedom for 48 months [4] - The long-term safety profile of azetukalner was consistent with that observed during the double-blind period, indicating a favorable tolerability [5] Group 2: Real-World Studies on Depression in Epilepsy - A study found that 80.6% of patients with focal seizures reported depressed mood, highlighting the significant mental health burden among this population [7] - Newly diagnosed epilepsy patients with depression had a higher prevalence of comorbidities and an increased risk of treatment failure, emphasizing the need for tailored treatment strategies [8] - Patients with moderate to severe depression symptoms experienced a lower quality of life and higher healthcare resource utilization, reinforcing the necessity for routine depression screening in epilepsy care [9] Group 3: Pipeline and Future Directions - Xenon is preparing to share Phase 3 data from the X-TOLE2 study in early 2026, which is anticipated to be a significant milestone for the company and the epilepsy community [2] - The company is also advancing early-stage programs targeting potassium and sodium channels for potential pain treatment, indicating a broadening of its therapeutic focus [15]

Core Viewpoint - Xenon Pharmaceuticals reported a narrower loss than expected for Q3 2025, with shares increasing by approximately 9.7% since the last earnings report, outperforming the S&P 500 [1][3]. Financial Performance - The company reported a loss of $1.15 per share for Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $1.16, compared to a loss of $0.81 per share in the same quarter last year [3]. - Xenon did not generate any revenues in the reported quarter, similar to the year-ago quarter, as it lacks a marketed product and only recognizes collaboration revenues from its partnership with Neurocrine Biosciences [4]. - Research and development (R&D) expenses rose by 35% year-over-year to $77.1 million, driven by costs related to late-stage studies in epilepsy and major depressive disorder (MDD), as well as increased personnel expenses [5]. - General and administrative expenses increased by 16% year-over-year to $19.3 million, primarily due to higher professional and consulting fees [6]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $555.3 million, down from $624.8 million as of June 30, 2025, which is expected to fund operations through 2027 [7]. Market Sentiment and Estimates - Estimates for Xenon Pharmaceuticals have trended upward over the past month, indicating a positive outlook despite the current Zacks Rank of 3 (Hold) [8][10]. - The company has a poor Growth Score of F and a Momentum Score of C, with an overall VGM Score of F, placing it in the bottom 20% for value investors [9]. Industry Comparison - Xenon Pharmaceuticals is part of the Zacks Medical - Biomedical and Genetics industry, where BioMarin Pharmaceutical (BMRN) has seen a 2.6% gain over the past month, reporting revenues of $776.13 million for the last quarter, a year-over-year increase of 4.1% [11][12].

Core Insights - Xenon Pharmaceuticals Inc. is hosting an investor webinar on December 10, 2025, to present data from the American Epilepsy Society Annual Meeting, focusing on long-term data from the X-TOLE study of azetukalner and real-world data on depression in epilepsy [1][2] - Azetukalner is a novel Kv7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder, and bipolar depression [3] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of therapeutics [3] - The company is advancing a portfolio of potassium and sodium channel modulators, including Kv7 and Nav1.7 programs in Phase 1 development for pain treatment [3] Webinar Details - The webinar will take place from 10:00 to 11:00 AM Eastern Time, with a live webcast available on the company's website [2] - Participants can submit questions via chat during the webinar or in advance via email [2]

Core Insights - Xenon Pharmaceuticals Inc. is set to present multiple research findings at the American Epilepsy Society Annual Meeting (AES 2025) from December 5-9, 2025, focusing on their lead molecule azetukalner for epilepsy treatment [1][5][9] - The presentations will include long-term data from the X-TOLE open-label extension study, which supports the potential for extended seizure freedom with azetukalner [1][5][6] - Additional findings will address the impact of depression on epilepsy patients and new pre-clinical data from the NaV1.1 program targeting Dravet syndrome [1][5][9] Presentation Details - Seven posters will be presented, including: - Long-term safety and efficacy data of azetukalner in adults with focal epilepsy, with a ≥48-month interim analysis from the ongoing 7-year X-TOLE study [6] - Characterization of long-term seizure freedom in the ongoing open-label extension of X-TOLE [6] - Studies on depression symptoms among epilepsy patients and their impact on treatment outcomes [6][5] - A symposium titled "Exploring Depression and Anxiety in Epilepsy" will be held in partnership with the Epilepsy Foundation of America [5] Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery and development of therapeutics for epilepsy and other neurological disorders [9] - The company's lead molecule, azetukalner, is a selective KV7 potassium channel opener currently in Phase 3 clinical trials for epilepsy, major depressive disorder, and bipolar depression [9] - Xenon is also advancing early-stage programs targeting potassium and sodium channels for potential pain treatment [9]