1. BURNABY, British Columbia, Oct. 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 10,000,000 common shares, which includes 1,525,423 shares sold upon the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 1,694,915 common shares. The common shares were offered at a public offering price of $29.50 per common share and the pre-funded warrants were offered at a price of $29.4999 per pre-funded warrant, with each pre-funded warrant having an exercise price of $0.0001. The aggregate gross proceeds to Xenon from the offering, before deducting…

    BURNABY, British Columbia, Oct. 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 10,000,000 common shares, which includes 1,525,423 shares sold upon the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 1,694,915 common shares. The common shares were offered at a public offering price of $29.50 per common share and the pre-funded warrants were offered at a price of $29.4999 per pre-funded warrant, with each pre-funded warrant having an exercise price of $0.0001. The aggregate gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, were approximately $345.0 million.

    Jefferies, SVB Leerink, Stifel and RBC Capital Markets acted as joint book-running managers for the offering. Wedbush PacGrow acted as co-manager for the offering.

    An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on October 4, 2021. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on October 6, 2021 and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@svbleerink.com; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at syndprospectus@stifel.com; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089, or by email at equityprospectus@rbccm.com.

    No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Media/Investor Contacts:

    Maria McClean / Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604-484-3353 / 778-999-5634

    Email: investors@xenon-pharma.com



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  2. BURNABY, British Columbia, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 8,474,577 common shares and, in lieu of common shares to certain investors, pre-funded warrants to purchase up to 1,694,915 common shares pursuant to its existing shelf registration statement. The common shares are being offered at a public offering price of $29.50 per common share and the pre-funded warrants are being offered at a price of $29.4999 per pre-funded warrant. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, are expected…

    BURNABY, British Columbia, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 8,474,577 common shares and, in lieu of common shares to certain investors, pre-funded warrants to purchase up to 1,694,915 common shares pursuant to its existing shelf registration statement. The common shares are being offered at a public offering price of $29.50 per common share and the pre-funded warrants are being offered at a price of $29.4999 per pre-funded warrant. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, are expected to be approximately $300.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days to purchase up to an additional 1,525,423 common shares at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about October 8, 2021, subject to customary closing conditions.

    Jefferies, SVB Leerink, Stifel and RBC Capital Markets are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

    An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on October 4, 2021. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@svbleerink.com; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at syndprospectus@stifel.com; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089, or by email at equityprospectus@rbccm.com.

    No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact and include statements regarding the anticipated closing of the public offering. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, as well as the other risks identified in our filings with the SEC and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Media/Investor Contacts:

    Maria McClean / Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604-484-3353 / 778-999-5634

    Email: investors@xenon-pharma.com



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  3. BURNABY, British Columbia, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of $250 million of its common shares pursuant to its existing shelf registration statement. It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional $37.5 million of common shares at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies, SVB Leerink, Stifel and RBC Capital Markets…

    BURNABY, British Columbia, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of $250 million of its common shares pursuant to its existing shelf registration statement. It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional $37.5 million of common shares at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies, SVB Leerink, Stifel and RBC Capital Markets are acting as joint book-running managers for the offering.

    An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on October 4, 2021. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@svbleerink.com; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at syndprospectus@stifel.com; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089, or by email at equityprospectus@rbccm.com.

    No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact and include statements regarding the anticipated public offering. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, as well as the other risks identified in our filings with the SEC and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Media/Investor Contacts:

    Maria McClean / Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604-484-3353 / 778-999-5634

    Email: investors@xenon-pharma.com



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  4. Xenon to Host Conference Call and Live Webcast Today at 7:30 am Eastern Time

    BURNABY, British Columbia, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported positive topline results from the Phase 2b X-TOLE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of XEN1101 – a differentiated Kv7 potassium channel modulator – administered as adjunctive treatment in adult patients with focal epilepsy.

    The trial met its primary efficacy endpoint with XEN1101 demonstrating a statistically…

    All Primary and Secondary Seizure Reduction Endpoints Statistically Significant Across All Dose Groups, with p-value of <0.001 for 20 mg and 25 mg Dose Groups

    Xenon to Host Conference Call and Live Webcast Today at 7:30 am Eastern Time

    BURNABY, British Columbia, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported positive topline results from the Phase 2b X-TOLE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of XEN1101 – a differentiated Kv7 potassium channel modulator – administered as adjunctive treatment in adult patients with focal epilepsy.

    The trial met its primary efficacy endpoint with XEN1101 demonstrating a statistically significant and dose-dependent reduction from baseline in monthly (defined as 28 days) focal seizure frequency when compared to placebo (monotonic dose response; p<0.001). Additional primary and secondary measures included a pairwise comparison of each active dose to placebo and a responder analysis with the proportion of patients who achieved a 50% or greater reduction in monthly focal seizure frequency from baseline. These results are shown in the following table; all p-values are 2-sided comparing the active dose to placebo:

     XEN1101 25 mg

    (N=112)
    XEN1101 20 mg

    (N=51)
    XEN1101 10mg

    (N=46)
    Placebo

    (N=114)
    Median Reduction from Baseline

    in Monthly Focal Seizure

    Frequency
    52.8%

    (p<0.001)
    46.4%

    (p<0.001)
    33.2%

    (p=0.035)



    18.2%
    Patients with at least a 50%

    Reduction in Monthly Focal

    Seizure Frequency from Baseline
    54.5%

    (p<0.001)
    43.1%

    (p<0.001)
    28.3%

    (p=0.037)
    14.9%

    Jacqueline A. French, MD, Professor in the Department of Neurology at NYU Langone Health and Co-director of Epilepsy Clinical Trials at NYU Langone's Comprehensive Epilepsy Center; Founder/Director of the Epilepsy Study Consortium; and Chair of the XEN1101 X-TOLE Steering Committee, stated, "Many patients today are living with the debilitating impacts of focal seizures, even while taking multiple anti-seizure medications, so there is a substantial need for new, efficacious and well-tolerated therapies. The X-TOLE results generated from this large, multicenter, controlled trial are truly exciting because they demonstrate impressive efficacy of XEN1101 for adult patients with focal epilepsy, including those with seizures that are deemed difficult to treat. In addition, physicians and patients could benefit from XEN1101's other important attributes, such as once-a-day dosing in the evening with no titration. With its unique potassium channel mechanism-of-action, the strength of these topline data suggest XEN1101 could play an important role in treating focal epilepsy."

    Dr. Christopher Kenney, Xenon's Chief Medical Officer commented, "On behalf of the entire Xenon team, I wish to extend our thanks to the patients, investigators, and site coordinators who participated in the X-TOLE study. We have generated strong evidence that supports the efficacy, safety and tolerability of XEN1101 and depicts a highly favorable product profile for XEN1101. Importantly, we saw statistically significant reductions of focal onset seizures compared to placebo across all dose groups, which suggests it is highly active in the central nervous system. With these compelling topline results, we are eager to work with the FDA to plan for an expedited development path moving forward."

    Designed as a randomized, double-blind, placebo-controlled, multicenter study, the Phase 2b X-TOLE clinical trial evaluated the clinical efficacy, safety, and tolerability of XEN1101 administered as once-daily adjunctive treatment in adult patients with focal epilepsy. The study included a total of 325 randomized and treated subjects in the safety population and 323 subjects in the modified intent to treat population for the efficacy analyses. Subjects had an average age of 40.8 ± 13.3 years, and 8.9%, 40.3%, or 50.8% of the subjects were on and continued taking one, two, or three stable background anti-seizure medications (ASMs) throughout the study, respectively, and failed a median of 6 previous ASMs prior to study entry. The median baseline seizure frequency across the study groups was approximately 13.5 per month. Of the 285 subjects who completed the double-blind period, 96.5% entered the open-label extension to evaluate the long-term safety, tolerability, and effectiveness of XEN1101.

    Summary of Results

    Key Efficacy Findings:

    • The primary objective of the study was to assess the dose response trend of XEN1101 in reducing monthly focal seizure frequency, based on a ranked ANCOVA model. The median percent reduction in monthly focal seizure frequency was 52.8% in the XEN1101 25 mg group, 46.4% in the XEN1101 20 mg group, and 33.2% in the XEN1101 10 mg group compared to 18.2% in the placebo group. The monotonic dose response relationship between the XEN1101 active dose groups compared to placebo was statistically significant (p<0.001). These data demonstrated a highly statistically significant dose-response relationship for XEN1101 in the adjunctive treatment of focal seizures in adult patients with a history of difficult-to-treat seizures.



    • In addition, XEN1101 demonstrated a statistically significant reduction from baseline in monthly focal seizure frequency in pairwise comparisons to placebo for all three XEN1101 doses. The median percent reduction in monthly focal seizure frequency was 52.8% in the XEN1101 25 mg group, 46.4% in the XEN1101 20 mg group, and 33.2% in the XEN1101 10 mg group compared to 18.2% in the placebo group. Statistical significance was achieved for all dose groups compared to placebo with 2-sided p-values of p<0.001 for 25 mg vs. placebo, p<0.001 for 20 mg vs. placebo, and p=0.035 for 10 mg vs. placebo.



    • A key secondary endpoint of the study was a responder analysis, which compared the proportion of study subjects treated with XEN1101 who achieved a ≥50% reduction in monthly focal seizures versus placebo. The percentage of subjects who achieved a >50% reduction in monthly focal seizures was 54.5% in the XEN1101 25 mg group, 43.1% in the XEN1101 20 mg group, and 28.3% in the XEN1101 10 mg group compared to 14.9% in the placebo group. Statistical significance was achieved for all dose groups compared to placebo with 2-sided p-values of p<0.001 for 25 mg vs. placebo, p<0.001 for 20 mg vs. placebo, and p=0.037 for 10 mg vs placebo.



    • These marked reductions in seizures were associated with statistically significant improvements in overall status, as assessed by physicians using the Clinical Global Impression of Change (CGI-C) and by subject self-reporting using the Patient Global Impression of Change (PGI-C) scales in the XEN1101 25 mg group, which are shown in the table below with 2-sided p-values:



     XEN1101 25 mg

    (N=112)
    Placebo

    (N=114)
    CGI-C (Portion of Patients Much Improved

    or Very Much Improved)
    46.4%

    (p<0.001)



    22.8%
    PGI-C (Portion of Patients Much Improved

    or Very Much Improved)
    42.9%

    (p=0.001)
    21.9%

    In addition to the statistically significant CGI-C and PGI-C in the XEN1101 25 mg group, the XEN1101 20 mg group was statistically significant in PGI-C, while the XEN1101 20 mg group in CGI-C and the XEN1101 10 mg group for both CGI-C and PGI-C showed numerical improvements over placebo but were not statistically significant.

    Key Safety and Tolerability Findings

    • XEN1101 was generally well-tolerated in this study with adverse events (AEs) consistent with other ASMs. The incidence of treatment-emergent adverse events (TEAEs) was higher in the treatment groups as compared to the placebo group, with 62.3% of patients in the placebo group, 67.4% of patients in the XEN1101 10 mg group, 68.6% of patients in the XEN1101 20 mg group, and 85.1% of patients in the XEN1101 25 mg group experiencing at least one TEAE. The most common TEAEs across all XEN1101 dose groups (n=211) were dizziness (n=52, 24.6%), somnolence (n=33, 15.6%), fatigue (n=23, 10.9%), and headache (n=21, 10.0%). Two TEAEs of urinary retention were reported in the active treatment groups, one of which required a dose reduction, and both subjects remained on drug with no other changes or intervention. Electrocardiogram (ECG) interval changes were infrequent and evenly balanced between placebo and active treatment groups. There have been no TEAEs of pigmentary abnormalities reported during the double-blind phase of the study or in preliminary analysis during the ongoing open-label extension to date with approximately 70 subjects now treated more than 12 months.



    • The incidence of treatment-emergent serious adverse events (SAEs) was similar in all four arms of the study with 2.6% of patients in the placebo group, 4.3% of patients in the XEN1101 10 mg group, 3.9% of patients in the XEN1101 20 mg group, and 2.6% of patients in the XEN1101 25 mg group experiencing at least one treatment-emergent SAE.



    • There were 3.5% of subjects in the placebo group, 2.2% of subjects in the XEN1101 10 mg group, 13.7% of subjects in the XEN1101 20 mg group, and 15.8% of subjects in the XEN1101 25 mg group that had an AE leading to treatment discontinuation.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "We believe that the X-TOLE topline data support a very attractive clinical profile for XEN1101 with desirable attributes that help differentiate it from other ASMs and suggest XEN1101 could be highly competitive in the future adult focal seizure market. Of importance, the XEN1101 efficacy data are especially compelling given that approximately 50% of the subjects in X-TOLE were using three concomitant ASMs, suggesting that this was potentially an even more challenging patient population than previous studies with other ASMs. Additionally, these data signal activity of XEN1101 in the central nervous system, which further supports our plans to develop XEN1101 in other indications, including major depressive disorder and other types of epilepsy."

    Xenon intends to gather input from the U.S. Food and Drug Administration and other regulatory agencies to continue planning the future clinical development of XEN1101. In addition, the X-TOLE open-label extension, which has been expanded to three years, is expected to generate important long-term data for XEN1101.

    Conference Call Information

    Xenon will host a conference call and live webcast with slides today at 7:30 am Eastern Time (4:30 am Pacific Time) to discuss the topline results from the XEN1101 Phase 2b X-TOLE clinical trial. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 4481713.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN1101; the anticipated initiation of future clinical trials for XEN1101; the timing and results of our planned interactions with regulators regarding XEN1101; and our ability to successfully develop and obtain regulatory approval of XEN1101. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; any of our or our collaborators' product candidates, including XEN1101, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Media/Investors Contact:

    Maria McClean / Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353 / 469-743-1834

    Email: investors@xenon-pharma.com

     



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  5. BURNABY, British Columbia, Oct. 03, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced that Xenon management will host a conference call and webcast to discuss topline results from the XEN1101 Phase 2b "X-TOLE" clinical trial on Monday, October 4, 2021 at 7:30 am Eastern Time.

    • A conference call and webcast with slides will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 4481713.

    The above listed dates and times are subject to change. When available, webcasts will be posted for replay following the event.

    About

    BURNABY, British Columbia, Oct. 03, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced that Xenon management will host a conference call and webcast to discuss topline results from the XEN1101 Phase 2b "X-TOLE" clinical trial on Monday, October 4, 2021 at 7:30 am Eastern Time.

    • A conference call and webcast with slides will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 4481713.

    The above listed dates and times are subject to change. When available, webcasts will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Media / Investor Contacts:

    Maria McClean / Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604-484-3353 / 778-999-5634

    Email: investors@xenon-pharma.com



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  6. BURNABY, British Columbia, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced that its collaboration to develop treatments for epilepsy with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) achieved a regulatory milestone with the approval of a clinical trial application (CTA) in Europe, triggering an aggregate payment of $10.0 million to Xenon.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "This $10 million regulatory milestone from our collaboration with Neurocrine Biosciences marks a significant achievement. We look forward to Neurocrine Biosciences initiating a Phase 2 clinical trial for NBI-921352 for the treatment of focal-onset…

    BURNABY, British Columbia, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced that its collaboration to develop treatments for epilepsy with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) achieved a regulatory milestone with the approval of a clinical trial application (CTA) in Europe, triggering an aggregate payment of $10.0 million to Xenon.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "This $10 million regulatory milestone from our collaboration with Neurocrine Biosciences marks a significant achievement. We look forward to Neurocrine Biosciences initiating a Phase 2 clinical trial for NBI-921352 for the treatment of focal-onset seizures in adults later this year. In addition, Neurocrine Biosciences also expects to initiate a Phase 2 clinical trial in adolescent patients with SCN8A developmental and epileptic encephalopathy in the second half of 2021. Ultimately, our hope is that this partnership will result in new treatments to benefit the lives of people with epilepsy."

    Based on the regulatory approval of a CTA in Europe for NBI-921352 for focal-onset seizures in adults, Xenon will receive an aggregate of $10.0 million from Neurocrine Biosciences in the form of a $4.5 million payment in cash and a $5.5 million equity investment at a Xenon per share price of $19.9755, calculated as a 15% premium to Xenon's 30-day trailing volume weighted average price.

    About the Collaboration Between Xenon and Neurocrine Biosciences

    Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in SCN8A-DEE patients. Based on this feedback, Neurocrine Biosciences anticipates initiating a Phase 2 clinical trial in adolescent patients (aged 12 years and older) with SCN8A-DEE in the second half of 2021, and the trial protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. Upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, Xenon is eligible to receive an aggregate payment of $15.0 million in the form of 45% cash and a 55% equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time. In parallel, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of focal-onset seizures in adults and expects to initiate a Phase 2 clinical trial in 2021.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to NBI-921352 and other partnered and proprietary product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of NBI-921352 and other partnered and proprietary product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for NBI-921352 and other partnered and proprietary product candidates; the efficacy of our clinical trial designs; the timing and results of our and our collaborators' interactions with regulators; our ability to successfully develop and achieve milestones in our NBI-921352 program with Neurocrine Biosciences and other partnered and proprietary programs; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from Neurocrine Biosciences and our other collaborators; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  7. BURNABY, British Columbia, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced the appointment of Christopher Kenney, M.D. as Chief Medical Officer, effective immediately. Dr. Kenney will oversee all clinical development and medical affairs strategies, guiding the development of Xenon's portfolio of neurology-focused therapeutic programs.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, stated, "We are thrilled to welcome Chris to the Xenon senior leadership team as we enter an important period with multiple mid- to late-stage programs advancing within our neurology pipeline and continued progress from our partnered programs. Chris' extensive…

    BURNABY, British Columbia, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced the appointment of Christopher Kenney, M.D. as Chief Medical Officer, effective immediately. Dr. Kenney will oversee all clinical development and medical affairs strategies, guiding the development of Xenon's portfolio of neurology-focused therapeutic programs.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, stated, "We are thrilled to welcome Chris to the Xenon senior leadership team as we enter an important period with multiple mid- to late-stage programs advancing within our neurology pipeline and continued progress from our partnered programs. Chris' extensive industry experience that encompasses all stages of clinical development including successful drug approvals – as well as his background as a neurologist – represent a great fit with Xenon. I believe Chris will play a critical role moving forward, especially as we look ahead to the topline data from our XEN1101 Phase 2b X-TOLE study anticipated in late September to mid-October."

    Dr. Christopher Kenney commented, "I am dedicated to developing new therapies to improve the lives of patients with neurological disorders and eager to join Xenon at this exciting time of growth when a number of therapeutic candidates are advancing through clinical development. In the near-term, I am looking forward to the XEN1101 Phase 2b X-TOLE study readout as I believe this promising, novel potassium channel modulator could potentially address a true unmet medical need for patients with focal seizures."

    Dr. Christopher Kenney is a board-certified neurologist with extensive clinical research experience within neuroscience in both industry and academic roles spanning more than 20 years. Most recently, Dr. Kenney served as Chief Medical Officer at Cadent Therapeutics, a biotech company focused on creating breakthrough therapies for neurological and psychiatric conditions, from 2019 until December 2020 when it was acquired by Novartis. Previously, Dr. Kenney was Senior Vice President of Medical Affairs (2018-2019) and Senior Vice President, Clinical Development (2016-2018) at Acorda Therapeutics. Prior to that position, from 2013 to 2016, Dr. Kenney served as Vice President/Senior Vice President of Clinical Development at Biotie Therapies, a biotechnology company focused on neurodegenerative and psychiatric disorders that was acquired by Acorda Therapeutics in January 2016. Before joining Biotie, Dr. Kenney worked in clinical development at Novartis and Merck Serono. Dr. Kenney's core medical and neurology training took place at Boston University School of Medicine and at University of California, San Diego (UCSD). Dr. Kenney held faculty positions at Baylor (2005-2007) and UCSD (2003-2005). In 2020, Dr. Kenney was appointed as a Fellow of the American Academy of Neurology.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities relating to our proprietary and partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of our proprietary and partnered product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in our proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; and the progress and potential of our other ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  8. Topline Data from XEN1101 Phase 2b "X-TOLE" Clinical Trial Anticipated Late September to Mid-October 2021

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "We continue to make strong progress across our portfolio of proprietary and partnered neurology-focused therapeutic programs. Importantly, we remain on track to report topline data from our XEN1101 Phase 2b X-TOLE study in late September to mid-October and believe these…

    Topline Data from XEN1101 Phase 2b "X-TOLE" Clinical Trial Anticipated Late September to Mid-October 2021

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "We continue to make strong progress across our portfolio of proprietary and partnered neurology-focused therapeutic programs. Importantly, we remain on track to report topline data from our XEN1101 Phase 2b X-TOLE study in late September to mid-October and believe these results could represent a key inflection point for the company. In anticipation of this important milestone, last month, we hosted a webinar with two leading key opinion leaders in the epilepsy space to discuss the focal epilepsy landscape, the X-TOLE clinical trial and the important attributes of XEN1101 and its potential in the treatment of adult focal epilepsy."

    Mr. Mortimer added, "Patient enrollment continues in our XEN496 Phase 3 ‘EPIK' clinical trial, as well as the investigator-led study examining XEN007 in absence seizures. We also expect that our partnered programs will reach important milestone events in 2021, with Neurocrine Biosciences anticipating the advancement of NBI-921352 into Phase 2 clinical development, and Flexion Therapeutics expecting topline results from its Phase 1b FX301 clinical trial."

    Highlights and Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, Xenon's "X-TOLE" study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Based on the completion in late June of the randomization of 326 patients, Xenon anticipates topline results from the Phase 2b X-TOLE clinical trial in late September to mid-October 2021. On July 12, 2021, Xenon hosted a KOL webinar focused on XEN1101 and the adult focal epilepsy landscape. As part of a strategy to continue to expand the intellectual property protecting XEN1101, Xenon recently obtained allowance of a U.S. patent application with claims directed to four distinct crystalline forms of XEN1101, pharmaceutical compositions comprising the same, and methods of preparing and using the same. Any patent issuing from this allowed application is expected to expire in Q4 2040.

    • Xenon also continues to evaluate opportunities to develop XEN1101 in neurological indications outside of epilepsy that could be well suited to its unique mechanism of action. Xenon is collaborating with the Icahn School of Medicine at Mount Sinai to facilitate an investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled clinical trial of XEN1101 for the treatment of major depressive disorder (MDD) and anhedonia, which is expected to be initiated in the coming months. In parallel, Xenon is planning a company-sponsored clinical study in MDD supported by promising pre-clinical data with XEN1101 and clinical data generated from both an open-label study and a randomized, placebo-controlled clinical trial that explored the targeting of KCNQ channels as a treatment for MDD using ezogabine.

    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Xenon has received Fast Track designation and Orphan Drug Designation (ODD) for XEN496 for the treatment of seizures associated with KCNQ2-DEE from the U.S. Food and Drug Administration (FDA), as well as orphan medicinal product designation from the European Commission. A Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial, called the "EPIK" study, is underway to evaluate the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE.

    • XEN007 (active ingredient flunarizine) is a CNS-acting Cav2.1 and T-type calcium channel modulator that is being studied in treatment-resistant absence seizures and potentially other neurological disorders. Recently, the FDA granted ODD and rare pediatric disease (RPD) designation for the treatment of childhood absence epilepsy (CAE) with XEN007. The FDA grants the RPD designation for serious or life-threatening diseases that primarily affect children 18 years old or younger and affect fewer than 200,000 people nationwide. An investigator-led Phase 2 proof-of-concept study is ongoing to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant absence seizures, including CAE and juvenile absence epilepsy (JAE). Promising interim data collected from a small number of patients was presented at the virtual annual meeting of the American Epilepsy Society in December 2020. The lead investigator has expanded the study to include an additional site, which is currently screening patients, and is also evaluating the addition of other sites. Additional results from a larger data set are anticipated by the end of this year, which will inform Xenon's decision regarding the future development of XEN007.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in SCN8A-DEE patients. Based on this feedback, Neurocrine Biosciences anticipates initiating a Phase 2 clinical trial in adolescent patients (aged 12 years and older) with SCN8A-DEE in the third quarter of 2021, and the trial protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. In parallel, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy and expects to initiate a Phase 2 clinical trial in 2021. Upon IND or equivalent regulatory acceptance for NBI-921352 in adult focal epilepsy, Xenon is eligible to receive a $10.0 million milestone payment; upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, Xenon is eligible to receive a $25.0 million milestone payment, or a $15.0 million milestone payment if the IND acceptance for adult focal epilepsy occurs first. Both milestone payments are in the form of 45% cash and a 55% equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.

    • Flexion Therapeutics acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. On March 31, 2021, Flexion announced the treatment of the first patient in a Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy. Flexion anticipates data from the Phase 1b trial of FX301 in late 2021. Pursuant to the terms of the agreement, Xenon is eligible to receive certain clinical, regulatory, and commercial milestone payments, as well as future sales royalties.

    Second Quarter 2021 Financial Results

    Cash and cash equivalents and marketable securities as of June 30, 2021 were $260.5 million, compared to $177.0 million as of December 31, 2020. As of June 30, 2021, there were 41,117,568 common shares, 1,081,081 pre-funded warrants and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations.

    Based on current assumptions, which include fully supporting the XEN1101 X-TOLE trial and company-sponsored MDD proof-of-concept study, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2023, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the quarter ended June 30, 2021, Xenon reported total revenue of $2.2 million, compared to $13.4 million for the same period in 2020. The decrease of $11.2 million was primarily attributable to deferred revenue associated with the transfer of exclusive licenses and associated technology and know-how for certain compounds under the license and collaboration agreement with Neurocrine Biosciences being fully recognized by December 2020.

    Research and development expenses for the quarter ended June 30, 2021 were $18.4 million, compared to $10.7 million for the same period in 2020. The increase of $7.7 million was primarily attributable to increased spending on Xenon's clinical development product candidates XEN496 and XEN1101 and increased spending on pre-clinical, discovery and other internal programs.

    General and administrative expenses for the quarter ended June 30, 2021 were $6.3 million compared to $3.3 million for the same period in 2020. The increase of $3.0 million was primarily attributable to increased stock-based compensation expense, legal fees for intellectual property protection and salaries and benefits from additional headcount.

    Other income for the quarter ended June 30, 2021 was $0.2 million compared to $0.4 million for the same period in 2020. The decrease was primarily attributable to lower interest income and foreign exchange gains, partially offset by a one-time loss on the repayment of a term loan with Silicon Valley Bank recognized in the same period in 2020.

    Net loss for the quarter ended June 30, 2021 was $22.1 million, compared to $0.2 million for the same period in 2020. The change was primarily attributable to lower revenue and interest income as well as higher research and development and general and administrative expenses as compared to the same period in 2020.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the second quarter results and provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 1491578.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2023; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Balance Sheets

    (Expressed in thousands of U.S. dollars)

      June 30,  December 31, 
      2021  2020 
    Assets        
    Current assets:        
    Cash and cash equivalents and marketable securities $260,523  $176,997 
    Other current assets  6,232   4,786 
    Other assets  7,956   7,403 
    Total assets $274,711  $189,186 
             
    Liabilities        
    Current liabilities:        
    Accounts payable and accrued expenses $11,198  $10,874 
    Deferred revenue  3,025   3,642 
    Other current liabilities  759   265 
    Other liabilities  2,746   3,050 
    Total liabilities $17,728  $17,831 
             
    Shareholders' equity $256,983  $171,355 
    Total liabilities and shareholders' equity $274,711  $189,186 
             

    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Statements of Operations

    (Expressed in thousands of U.S. dollars except share and per share amounts)

      Three Months Ended June 30,Six Months Ended June 30, 
      2021  2020  2021  2020 
    Revenue $2,218  $13,384  $6,576  $20,462 
                     
    Operating expenses:                
    Research and development  18,377   10,720   34,685   22,511 
    General and administrative  6,339   3,310   10,448   6,630 
    Total operating expenses  24,716   14,030   45,133   29,141 
    Loss from operations  (22,498)  (646)  (38,557)  (8,679)
    Other income  172   432   399   980 
    Loss before income taxes  (22,326)  (214)  (38,158)  (7,699)
    Income tax recovery  217   39   285   40 
    Net loss and comprehensive loss  (22,109)  (175)  (37,873)  (7,659)
    Net loss attributable to preferred shareholders  (521)  (5)  (951)  (222)
    Net loss attributable to common shareholders $(21,588) $(170) $(36,922) $(7,437)
                     
    Net loss per common share:                
    Basic and diluted $(0.51) $(0.00) $(0.94) $(0.22)
    Weighted-average common shares outstanding:                
    Basic and diluted  43,106,207   34,979,282   40,473,413   34,084,508 
                     

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  9. BURNABY, British Columbia, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced its participation in one-on-one investor meetings as well as a virtual panel discussion at the 12th Annual Wedbush PacGrow Healthcare Conference.

    Panel Topic:"Got My Mind Set On You - Advancing Novel Epilepsy Targets"
      
    Date:Wednesday, August 11, 2021
      
    Time:11:30 am – 12 pm Eastern Time
      
    Panelist:Dr. Simon Pimstone, Executive Chair of the Board

    Additional details along with a link to the live webcast can be found on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event for 30 days…

    BURNABY, British Columbia, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced its participation in one-on-one investor meetings as well as a virtual panel discussion at the 12th Annual Wedbush PacGrow Healthcare Conference.

    Panel Topic:"Got My Mind Set On You - Advancing Novel Epilepsy Targets"
      
    Date:Wednesday, August 11, 2021
      
    Time:11:30 am – 12 pm Eastern Time
      
    Panelist:Dr. Simon Pimstone, Executive Chair of the Board

    Additional details along with a link to the live webcast can be found on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event for 30 days. The above listed dates and times are subject to change.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  10. BURNABY, British Columbia, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced it will report its second quarter 2021 financial and operating results after the close of U.S. financial markets on Wednesday, August 11, 2021.

    • Xenon management will host a conference call and live audio webcast on Wednesday, August 11, 2021 at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the second quarter 2021 financial results and provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference…

    BURNABY, British Columbia, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced it will report its second quarter 2021 financial and operating results after the close of U.S. financial markets on Wednesday, August 11, 2021.

    • Xenon management will host a conference call and live audio webcast on Wednesday, August 11, 2021 at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the second quarter 2021 financial results and provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 1491578.

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  11. BURNABY, British Columbia, July 13, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced its participation in a virtual fireside chat at the William Blair Biotech Focus Conference 2021.

    Date:Thursday, July 15, 2021
    Time:10 am – 10:45 am Eastern Time
    Participants:Ian Mortimer, President and CEO | Dr. Simon Pimstone, Executive Chair of the Board

    Additional details along with a link to the live webcast can be found on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event for 30 days. The above listed dates and times are subject to change.

    About Xenon Pharmaceuticals Inc.

    BURNABY, British Columbia, July 13, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today announced its participation in a virtual fireside chat at the William Blair Biotech Focus Conference 2021.

    Date:Thursday, July 15, 2021
    Time:10 am – 10:45 am Eastern Time
    Participants:Ian Mortimer, President and CEO | Dr. Simon Pimstone, Executive Chair of the Board

    Additional details along with a link to the live webcast can be found on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event for 30 days. The above listed dates and times are subject to change.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  12. BURNABY, British Columbia, July 07, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today provided an update on its ongoing XEN1101 Phase 2b "X-TOLE" clinical trial, announcing that randomization of 326 patients was completed in late June. Based on completion of patient randomization, Xenon anticipates topline results from the Phase 2b X-TOLE clinical trial in late September to mid-October 2021.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, said, "We are pleased to announce that patient randomization in our XEN1101 Phase 2b "X-TOLE" clinical trial is complete. Given the strong screening at the end of the recruitment period, we randomized more patients than…

    BURNABY, British Columbia, July 07, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today provided an update on its ongoing XEN1101 Phase 2b "X-TOLE" clinical trial, announcing that randomization of 326 patients was completed in late June. Based on completion of patient randomization, Xenon anticipates topline results from the Phase 2b X-TOLE clinical trial in late September to mid-October 2021.

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, said, "We are pleased to announce that patient randomization in our XEN1101 Phase 2b "X-TOLE" clinical trial is complete. Given the strong screening at the end of the recruitment period, we randomized more patients than the 300 originally planned, and we look forward to topline data in late September to mid-October. In advance of these results, we have invited two leading key opinion leaders in the epilepsy space – Dr. Jacqueline French and Dr. Michael Rogawski – to join us for a webinar to discuss XEN1101, the X-TOLE clinical trial, and the broader focal epilepsy landscape."

    Webinar Event:"A Discussion of XEN1101 and the Focal Epilepsy Landscape"
    Date:Monday, July 12, 2021
    Time: 10 am-12 pm Eastern Time (7 am-9 am Pacific Time)
    Registration: Participants may register on the Investors section of Xenon's website.

    Speakers on the July 12th webinar include:

    • Dr. Jacqueline French, Professor of Neurology in the Comprehensive Epilepsy Center at NYU Langone School of Medicine and Founder/Director of the Epilepsy Study Consortium
    • Dr. Michael Rogawski, Professor in the Department of Neurology with joint appointment in the Department of Pharmacology, and an affiliate member of the Center for Neuroscience at the University of California, Davis
    • Ian Mortimer, President and CEO, Xenon Pharmaceuticals
    • Dr. Simon Pimstone, Executive Chair of the Board, Xenon Pharmaceuticals
    • Dr. Chris Von Seggern, Chief Commercial Officer, Xenon Pharmaceuticals

    The webcast will be broadcast live on the Investors section of the Xenon website, and participants will be able to submit text questions via the webcast portal. The webinar will also be available for replay following the event.

    About XEN1101

    XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, Xenon's "X-TOLE" study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient randomization has been completed, and topline data are anticipated in late September to mid-October 2021.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials, including those related to XEN1101; the efficacy of our clinical trial designs; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN1101; and our ability to successfully develop and achieve milestones in the XEN1101 development program. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com 



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  13. BURNABY, British Columbia, June 03, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, provided a corporate update following its 2021 Annual Meeting of Shareholders (the "Annual Meeting") held today on June 3, 2021.

    Dr. Simon Pimstone, Executive Chair of Xenon's Board of Directors stated, "We announced plans for a leadership transition earlier in the year, implemented a seamless succession plan, and effected these appointments at our Annual Meeting. Ian Mortimer, who takes on the role of CEO and joins our board of directors, has worked alongside me for the past seven years and is ideally suited to lead Xenon, together with Sherry Aulin, who was appointed Xenon's Chief Financial…

    BURNABY, British Columbia, June 03, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, provided a corporate update following its 2021 Annual Meeting of Shareholders (the "Annual Meeting") held today on June 3, 2021.

    Dr. Simon Pimstone, Executive Chair of Xenon's Board of Directors stated, "We announced plans for a leadership transition earlier in the year, implemented a seamless succession plan, and effected these appointments at our Annual Meeting. Ian Mortimer, who takes on the role of CEO and joins our board of directors, has worked alongside me for the past seven years and is ideally suited to lead Xenon, together with Sherry Aulin, who was appointed Xenon's Chief Financial Officer. It has been a privilege to head up this talented executive team while serving Xenon's shareholders and other stakeholders and I look forward to moving into the role of Executive Chair of the Board to continue to support Xenon's goal to develop innovative therapeutics to improve the lives of patients with neurological disorders."

    Dr. Pimstone continued, "We are truly grateful for Michael Tarnow's 22 years of service on our Board, including his remarkable, committed leadership as Board Chair. In addition, we wish to recognize the important contributions of Frank Holler, who has been a member of our Board similarly for approximately two decades, including serving as the chair of our Audit Committee and previously serving as Xenon's founding President and CEO. The strategic advice offered by these long-serving directors is immeasurable, and their counsel helped Xenon achieve its strong position today."

    Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, said, "The entire Xenon team wishes to extend its deep gratitude to Simon for his vision and dedication to Xenon over the years, which has resulted in a broad pipeline of neurology-focused therapeutic candidates. Simon's guidance, leadership and mentorship has positively impacted so many of us, not just at Xenon but across the life sciences sector in Canada. I am excited to take on my new role as CEO, building upon the great amount of momentum in both our proprietary and partnered programs."

    Mr. Mortimer added, "We are also pleased to announce that Elizabeth Garofalo was elected to our Board of Directors at the Annual Meeting. Dr. Garofalo brings an immense amount of experience in the pharmaceutical industry with a particular focus on neurology development. As our epilepsy programs mature in clinical development, we believe Dr. Garofalo can provide invaluable strategic guidance, keeping the needs of patients in the forefront of our plans."

    Since 2016, Dr. Elizabeth Garofalo has served as the principal for EAG Pharma Consulting LLC. Previously, she served in numerous leadership roles including as Senior Vice President and Global Head of Clinical Development for Novartis and as a member of its Global Development Leadership Team; Chair of the Novartis Portfolio Stewardship Board; Co-Head of the Novartis Neuroscience Franchise; Head of the Neuroscience Therapy Area at Astellas; Ann Arbor Site Head of Worldwide Regulatory Affairs at Pfizer; and Ann Arbor Site Head of Neuroscience at Pfizer. Since September 2020, Dr. Garofalo has served on the Board of Acadia Pharmaceuticals Inc. and, since March 2021, as a Board director and member of the Audit Committee at Exicure Inc. She is a director of the non-profit Institute for Advanced Clinical Trials for Children (I-ACT) where she chairs the Pediatric Oversight Committee and is the Chair of the Business Advisory Board for the Epilepsy Foundation of America. She has an M.D. from the Indiana University School of Medicine and completed fellowships in pediatric neurology and epilepsy at the University of Michigan Medical School.

    Detailed voting results from each of the proposals at the Annual Meeting are summarized in a Form 8-K filed with the SEC and on SEDAR today.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the progress and potential of our other ongoing development programs; and the potential receipt of milestone payments and royalties from our collaborators. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  14. BURNABY, British Columbia, May 31, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that members of its executive management team will participate in the following investor conference:

    • Jefferies 2021 Virtual Healthcare Conference on Wednesday, June 2, 2021 at 3:00 pm ET. The live webcast of the fireside chat can be accessed here.

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical…

    BURNABY, British Columbia, May 31, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that members of its executive management team will participate in the following investor conference:

    • Jefferies 2021 Virtual Healthcare Conference on Wednesday, June 2, 2021 at 3:00 pm ET. The live webcast of the fireside chat can be accessed here.

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Contact:

    Maria McClean

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  15. Topline Data from XEN1101 Phase 2b "X-TOLE" Clinical Trial Anticipated by End of Third Quarter of 2021

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, May 11, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to make excellent progress across both our proprietary and partnered programs. In particular, I am pleased to report that we have completed patient screening in our Phase 2b ‘X-TOLE' clinical trial evaluating XEN1101 as an adjunctive treatment of focal epilepsy. With…

    Topline Data from XEN1101 Phase 2b "X-TOLE" Clinical Trial Anticipated by End of Third Quarter of 2021

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, May 11, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to make excellent progress across both our proprietary and partnered programs. In particular, I am pleased to report that we have completed patient screening in our Phase 2b ‘X-TOLE' clinical trial evaluating XEN1101 as an adjunctive treatment of focal epilepsy. With the final patients currently in baseline, we anticipate randomization to be completed in June and the release of topline data by the end of the third quarter. Additionally, we continue to initiate new sites to support ongoing patient enrollment in our Phase 3 "EPIK" study, which is evaluating XEN496 as a treatment of KCNQ2 developmental and epileptic encephalopathy.

    Mr. Ian Mortimer, Xenon's President and Chief Financial Officer added, "This quarter we successfully completed a public offering – resulting in approximately $115 million in gross proceeds to Xenon – to further fortify our balance sheet. We continue to prudently manage our resources and believe we have the team and capital in place to execute on our business and clinical development goals for this year. The additional capital will enable us to continue to expand our pipeline including a company sponsored clinical study of XEN1101 in major depressive disorder."

    Highlights and Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, Xenon's "X-TOLE" study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient screening has now been completed with the final patients currently in the baseline period. Patient randomization is expected to be complete in June, with topline data anticipated by the end of the third quarter of 2021.



    • Xenon also continues to evaluate opportunities to develop XEN1101 in neurological indications outside of epilepsy that could be well-suited to its unique mechanism of action. On March 8, 2021, Xenon announced a collaboration with the Icahn School of Medicine at Mount Sinai to facilitate an investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled clinical trial of XEN1101 for the treatment of major depressive disorder (MDD) and anhedonia, which is expected to be initiated in the coming months. In parallel, Xenon is planning a company-sponsored clinical study in MDD supported by promising pre-clinical data with XEN1101 and clinical data generated from both an open-label study and a randomized, placebo-controlled clinical trial that explored the targeting of KCNQ channels as a treatment for MDD using ezogabine.



    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Xenon has received Fast Track designation and Orphan Drug Designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE from the U.S. Food and Drug Administration (FDA), as well as orphan medicinal product designation from the European Commission. A Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial, called the "EPIK" study, is underway to evaluate the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE.



    • XEN007 (active ingredient flunarizine) is a CNS-acting Cav2.1 and T-type calcium channel modulator that is being studied in treatment-resistant childhood absence epilepsy (CAE) and potentially other neurological disorders. An investigator-led Phase 2 proof-of-concept study is ongoing to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant CAE. A presentation of promising interim data collected from a small number of patients was presented at the virtual annual meeting of the American Epilepsy Society in December 2020. Xenon continues to work with the lead investigator to include additional sites and expects that topline results from a larger data set will be available in the second half of 2021, which will inform Xenon's decision anticipated this year regarding the future development of XEN007 in CAE.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in SCN8A-DEE patients. Based on this feedback, Neurocrine Biosciences anticipates initiating a Phase 2 clinical trial in adolescent patients (aged 12 years and older) with SCN8A-DEE in the third quarter of 2021, and the trial protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. In parallel, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy and expects to initiate a Phase 2 clinical trial in 2021. Upon IND or equivalent regulatory acceptance for NBI-921352 in adult focal epilepsy, Xenon is eligible to receive a $10.0 million milestone payment; upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, Xenon is eligible to receive a $25.0 million milestone payment, or a $15.0 million milestone payment if the IND acceptance for adult focal epilepsy occurs first. Both milestone payments are in the form of 45% cash and a 55% equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.



    • Flexion Therapeutics acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. On March 31, 2021, Flexion announced the treatment of the first patient in a Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy. Flexion anticipates data from the Phase 1b trial of FX301 in late 2021. Pursuant to the terms of the agreement, Xenon is eligible to receive certain clinical, regulatory, and commercial milestone payments, as well as future sales royalties.

    First Quarter 2021 Financial Results

    Cash and cash equivalents and marketable securities as of March 31, 2021 were $274.7 million, compared to $177.0 million as of December 31, 2020. As of March 31, 2021, there were 40,962,715 common shares, 1,081,081 pre-funded warrants and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations.

    Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2023, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the quarter ended March 31, 2021, Xenon reported total revenue of $4.4 million, compared to $7.1 million for the same period in 2020. The decrease of $2.7 million was primarily attributable to deferred revenue associated with the license and collaboration agreement with Neurocrine Biosciences being fully recognized by December 2020, partially offset by $3.0 million in milestone revenue recognized in the quarter ended March 31, 2021 in connection with the agreement with Flexion.

    Research and development expenses for the quarter ended March 31, 2021 were $16.3 million, compared to $11.8 million for the same period in 2020. The increase of $4.5 million was primarily attributable to increased spending on Xenon's clinical development product candidates XEN496 and XEN1101, and, to a lesser extent, increased spending on pre-clinical, discovery and other internal programs.

    General and administrative expenses for the quarter ended March 31, 2021 were $4.1 million compared to $3.3 million for the same period in 2020. The increase of $0.8 million was primarily attributable to increased stock-based compensation expense and salaries and benefits, partially offset by a decrease in human resources costs due to the timing of recruitment fees.

    Other income for the quarter ended March 31, 2021 was $0.2 million compared to $0.5 million for the same period in 2020. The decrease was primarily attributable to decreased interest income, partially offset by an increase in foreign exchange gains and a decrease in interest expense due to the repayment of a term loan in May 2020.

    Net loss for the quarter ended March 31, 2021 was $15.8 million, compared to $7.5 million for the same period in 2020. The change was primarily attributable to lower revenue and interest income as well as higher research and development and general and administrative expenses as compared to the same period in 2020.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the first quarter results and provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 1496232.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2023; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Balance Sheets

    (Expressed in thousands of U.S. dollars)

      March 31,  December 31, 
      2021  2020 
    Assets        
    Current assets:        
    Cash and cash equivalents and marketable securities $274,703  $176,997 
    Other current assets  8,557   4,786 
    Other assets  7,411   7,403 
    Total assets $290,671  $189,186 
             
    Liabilities        
    Current liabilities:        
    Accounts payable and accrued expenses $7,580  $10,874 
    Deferred revenue  3,642   3,642 
    Other current liabilities  270   265 
    Other liabilities  2,902   3,050 
    Total liabilities $14,394  $17,831 
             
    Shareholders' equity $276,277  $171,355 
    Total liabilities and shareholders' equity $290,671  $189,186 

    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Statements of Operations

    (Expressed in thousands of U.S. dollars except share and per share amounts)

      Three Months Ended March 31, 
      2021  2020 
    Revenue $4,358  $7,078 
             
    Operating expenses:        
    Research and development  16,308   11,791 
    General and administrative  4,109   3,320 
    Total operating expenses  20,417   15,111 
    Loss from operations  (16,059)  (8,033)
    Other income  227   548 
    Loss before income taxes  (15,832)  (7,485)
    Income tax recovery  68   1 
    Net loss and comprehensive loss  (15,764)  (7,484)
    Net loss attributable to preferred shareholders  (423)  (222)
    Net loss attributable to common shareholders $(15,341) $(7,262)
             
    Net loss per common share:        
    Basic and diluted $(0.42) $(0.22)
    Weighted-average common shares outstanding:        
    Basic and diluted  36,824,619   33,189,733 

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  16. BURNABY, British Columbia, May 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced it will report its first quarter 2021 financial and operating results after the close of U.S. financial markets on Tuesday, May 11, 2021.

    • Xenon management will host a conference call and live audio webcast on Tuesday, May 11, 2021 at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the first quarter 2021 financial results and provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 1496232…

    BURNABY, British Columbia, May 04, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced it will report its first quarter 2021 financial and operating results after the close of U.S. financial markets on Tuesday, May 11, 2021.

    • Xenon management will host a conference call and live audio webcast on Tuesday, May 11, 2021 at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the first quarter 2021 financial results and provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 1496232.

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

     



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  17. BURNABY, British Columbia, April 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that members of its executive management team will present a corporate overview and participate in the following virtual investor conferences:

    • 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 am ET. The live webcast of the fireside chat can be accessed here.
    • 2021 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 3:00 pm ET. The live webcast of the company presentation can be accessed here.

    Details on company presentations and the links to webcasts can be found on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com

    BURNABY, British Columbia, April 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that members of its executive management team will present a corporate overview and participate in the following virtual investor conferences:

    • 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 am ET. The live webcast of the fireside chat can be accessed here.
    • 2021 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 3:00 pm ET. The live webcast of the company presentation can be accessed here.

    Details on company presentations and the links to webcasts can be found on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com. When available, webcasts will be posted for replay following the event for 30 days. The above listed dates and times are subject to change.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  18. BURNABY, British Columbia, March 29, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that the Company will participate in a fireside chat at the following virtual investor conference:

    • Stifel 3rd Annual CNS Day (fireside chat presentation) on Wednesday, March 31, 2021 at 1:00 pm ET

    The presentation will be webcast live and archived on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com.

    The above listed dates and times are subject to change.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders…

    BURNABY, British Columbia, March 29, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that the Company will participate in a fireside chat at the following virtual investor conference:

    • Stifel 3rd Annual CNS Day (fireside chat presentation) on Wednesday, March 31, 2021 at 1:00 pm ET

    The presentation will be webcast live and archived on the "Investors" section of Xenon's website at http://investor.xenon-pharma.com.

    The above listed dates and times are subject to change.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  19. BURNABY, British Columbia, March 12, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 5,135,135 common shares, which includes 810,810 shares sold upon the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 1,081,081 common shares. The common shares were offered at a public offering price of $18.50 per common share and the pre-funded warrants were offered at a price of $18.4999 per pre-funded warrant, with each pre-funded warrant having an exercise price of $0.0001. The aggregate gross proceeds to Xenon from the offering, before deducting…

    BURNABY, British Columbia, March 12, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 5,135,135 common shares, which includes 810,810 shares sold upon the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 1,081,081 common shares. The common shares were offered at a public offering price of $18.50 per common share and the pre-funded warrants were offered at a price of $18.4999 per pre-funded warrant, with each pre-funded warrant having an exercise price of $0.0001. The aggregate gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, were approximately $115.0 million.

    Jefferies, Stifel, and William Blair acted as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow acted as co-managers for the offering.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on June 3, 2020 and declared effective by the SEC on June 12, 2020. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on March 10, 2021 and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: prospectus@williamblair.com. 

    No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Xenon Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

     



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  20. BURNABY, British Columbia, March 09, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 4,324,325 common shares and, in lieu of common shares to a certain investor, pre-funded warrants to purchase up to 1,081,081 common shares pursuant to its existing shelf registration statement. The common shares are being offered at a public offering price of $18.50 per common share and the pre-funded warrants are being offered at a price of $18.4999 per pre-funded warrant. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, are expected…

    BURNABY, British Columbia, March 09, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 4,324,325 common shares and, in lieu of common shares to a certain investor, pre-funded warrants to purchase up to 1,081,081 common shares pursuant to its existing shelf registration statement. The common shares are being offered at a public offering price of $18.50 per common share and the pre-funded warrants are being offered at a price of $18.4999 per pre-funded warrant. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, are expected to be approximately $100.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days to purchase up to an additional 810,810 common shares at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about March 12, 2021, subject to customary closing conditions.

    Jefferies, Stifel, and William Blair are acting as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow are acting as co-managers for the offering.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on June 3, 2020 and declared effective by the SEC on June 12, 2020. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC's website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: prospectus@williamblair.com.

    No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact and include statements regarding the anticipated closing of the public offering. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, as well as the other risks identified in our filings with the SEC and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Xenon Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  21. BURNABY, British Columbia, March 09, 2021 (GLOBE NEWSWIRE) --  Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of its common shares and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase common shares, pursuant to its existing shelf registration statement. It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional 15% of the common shares offered in the offering, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no…

    BURNABY, British Columbia, March 09, 2021 (GLOBE NEWSWIRE) --  Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of its common shares and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase common shares, pursuant to its existing shelf registration statement. It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional 15% of the common shares offered in the offering, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies, Stifel, and William Blair are acting as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow are acting as co-managers for the offering.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on June 3, 2020 and declared effective by the SEC on June 12, 2020. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: prospectus@williamblair.com.

    No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated public offering. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, as well as the other risks identified in our filings with the SEC and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Xenon Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com 



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  22. BURNABY, British Columbia, March 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced a collaboration with the Icahn School of Medicine at Mount Sinai (Mount Sinai) to facilitate an investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled clinical trial of XEN1101 for the treatment of major depressive disorder (MDD) and anhedonia, which is an inability to feel pleasure. The principal investigator and sponsor of the Investigational New Drug (IND) application for the study is Dr. James W. Murrough, MD, PhD, Associate Professor of Psychiatry and Neuroscience at Mount Sinai. Xenon will supply the study drug, XEN1101, which is a proprietary…

    BURNABY, British Columbia, March 08, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced a collaboration with the Icahn School of Medicine at Mount Sinai (Mount Sinai) to facilitate an investigator-sponsored Phase 2 proof-of-concept, randomized, parallel-arm, placebo-controlled clinical trial of XEN1101 for the treatment of major depressive disorder (MDD) and anhedonia, which is an inability to feel pleasure. The principal investigator and sponsor of the Investigational New Drug (IND) application for the study is Dr. James W. Murrough, MD, PhD, Associate Professor of Psychiatry and Neuroscience at Mount Sinai. Xenon will supply the study drug, XEN1101, which is a proprietary, differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. The U.S. Food and Drug Administration (FDA) has accepted the IND, and study investigators have obtained Institutional Review Board (IRB) approval of the protocol in order to proceed with the Phase 2 XEN1101 MDD clinical trial, which is expected to be initiated in the second quarter of 2021.

    Dysfunction of the dopamine neurons in the ventral tegmental area (VTA) of the brain reward system is an important feature of depressive disorders and other comorbidities, including anhedonia. Evidence from preclinical studies has highlighted KCNQ-type (Kv7) neuronal potassium channels as novel targets for the treatment of depressive disorders capable of reversing the observed dysfunction in the dopamine neurons. In addition, promising results were generated from both an open-label study and a randomized, placebo-controlled clinical trial that explored the targeting of KCNQ channels as a treatment for MDD using ezogabine, an earlier-generation KCNQ potassium channel modulator that was withdrawn from the market for commercial reasons. Dr. Murrough and colleagues recently published the results from the randomized, placebo-controlled clinical trial of ezogabine in MDD and anhedonia in the American Journal of Psychiatry. For more information, refer to the news release issued by Mount Sinai on March 3, 2021: https://www.mountsinai.org/about/newsroom/2021/researchers-identify-brain-ion-channel-as-new-approach-to-treating-depression

    Dr. Murrough stated, "MDD is one of the most disabling medical conditions worldwide, and new treatments are urgently needed to address this large, public health burden. Our previous clinical work using ezogabine suggests that KCNQ channel potentiation may represent a novel treatment approach for depression. Ezogabine was well-tolerated in patients with depression and resulted in a significant improvement in symptoms of depression and anhedonia. Our hope is that this new study will generate useful data that supports the utility of XEN1101 in depressive disorders such as MDD, given its common mechanism of action combined with an advantageous pharmacokinetic profile when compared to ezogabine."

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "In addition to our ongoing Phase 2b X-TOLE study in adult patients with focal epilepsy, we have been exploring other neurological conditions for XEN1101. We have already completed Phase 1 and Phase 1b studies with XEN1101, establishing pharmacokinetic, toxicology, brain exposure and safety data. Dr. Murrough has generated promising, clinical results with the first generation Kv7 channel modulator ezogabine on reward circuit activity and clinical outcomes in patients with depression. This strategic collaboration allows us to further explore the potential we see for XEN1101 as a ‘next-gen' Kv7 channel modulator in patients with depressive disorders such as MDD and also supports our ongoing epilepsy work as depression is a significant co-morbidity in many patients with focal epilepsy."

    About the Phase 2 XEN1101 MDD Clinical Trial

    The Phase 2 investigator-sponsored XEN1101 MDD Study is designed as a multi-site, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to test the antidepressant effect of XEN1101 compared to placebo in patients with MDD and significant anhedonia. Approximately 60 patients with a primary diagnosis of MDD according to Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) will be randomized in a 1:1 manner under double-blind conditions. Following a screening period, each subject will receive a daily dose of study drug or placebo for 8 weeks. The primary objective of the study is to investigate the effect of XEN1101 on brain measures of reward as measured by the change in bilateral ventral striatum activity as assessed by functional MRI (fMRI). The secondary objectives are to test the effect of XEN1101 compared to placebo on clinical measures of depression and anhedonia using a variety of clinical scales including the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Snaith-Hamilton Pleasure Scale (SHAPS). This Phase 2 Study is expected to initiate in the second quarter of 2021.

    Scientific Rationale and Pre-Clinical Support for Studying XEN1101 in MDD

    Pre-clinical work demonstrates a regulatory role for the KCNQ-type potassium channels in reversing depressive phenotypes following social defeat stress (Krishnan et al. 2007; Friedman et al. 2014; Friedman et al. 2016). Mice resilient to depression and anhedonia exhibit increased KCNQ channel activity within the VTA, dampening the hyperexcitability of the dopamine neurons that is associated with depressive/anhedonia phenotypes observed in the susceptible mice. This susceptible phenotype can be reversed through (a) overexpression of KCNQ channels in the VTA dopamine neurons, (b) direct intra-VTA injection of KCNQ channel openers, or (c) systemic injection of KCNQ channel openers. Repeated peripheral daily administration of the KCNQ channel opener ezogabine completely reversed the depressive/anhedonic phenotype in the susceptible mice. XEN1101, a next-generation, more potent KCNQ channel opener, has been shown to have activity in several in vivo rodent models of electrically and chemically induced seizures and exhibits a selectivity for Kv7 channels over other ion channels and receptors. Moreover, XEN1101 was found to be relatively more selective for Kv7.2/7.3 over Kv7.3/7.5 and Kv7.4 channels, which may be relevant for the clinical profile of the drug. In vitro studies suggested a low potential for drug-drug interactions through the inhibition of the cytochrome isoenzymes, and data from Phase 1 clinical studies showed a favorable pharmacokinetic profile.

    Clinical Validation for Studying XEN1101 in MDD Based on Completed Studies with Ezogabine

    Dr. Murrough conducted two clinical studies using the first-generation Kv7 potassium channel modulator, ezogabine, in order to test the hypothesis that increasing KCNQ channel signaling can be beneficial for patients with depression and anhedonia. An open-label, proof-of-concept study was conducted with eighteen individuals with MDD in a major depressive episode (MDE) who received ezogabine up to 900 mg/day orally (within the approved range for seizure disorder) over the course of ten weeks. After treatment with ezogabine, subjects exhibited a significant reduction of depressive symptoms MADRS score change: −13.7±9.7, p<0.001, d=2.08 and anhedonic symptoms (Snaith-Hamilton Pleasure Scale (SHAPS) score change: −6.1±5.3, p<0.001, d=1.00), which remained significant even after controlling for overall depression severity (Tan et al 2018).

    The second study was a two-site, double-blind, randomized, placebo-controlled, proof-of-concept clinical trial designed as a preliminary test of the hypothesis that increasing KCNQ2/3 channel activity in the brain is a viable new approach for the treatment of depression. Forty-five adult patients diagnosed with a depressive disorder were assigned to a five-week treatment period with daily dosing of either ezogabine or matching placebo. All participants underwent clinical evaluations and functional magnetic resonance imaging (fMRI) during a reward task at baseline and at the end of the treatment period. Compared to patients treated with placebo, those treated with ezogabine showed a significant and large reduction in several key measures of depression severity, anhedonia, and overall illness severity. For example, significant improvements following treatment with ezogabine compared to placebo were observed using MADRS and the SHAPS clinical scales. In addition, the ezogabine group showed a trend towards an increase in response to reward anticipation in the brain compared to placebo. Relative to placebo (N=24), ezogabine (N=21; target dose 900 mg daily) was associated with a significantly larger improvement in symptoms of depression (MADRS score change: -7.9±3, p<.001), significantly larger improvement in symptoms of anhedonia (SHAPS score change: -6.9±3.2, p<.001), and other clinical endpoints. In both trials, ezogabine was well tolerated and no serious adverse events occurred. Overall, these results provide further support for the use of KCNQ channel potentiators as a novel treatment approach for MDD (Costi et al 2021).

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN1101; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN1101; the anticipated timing of the initiation of future clinical trials for XEN1101; the efficacy of clinical trial designs; our ability to successfully develop and achieve milestones in the XEN1101 and other proprietary and partnered development programs; anticipated enrollment in clinical trials and the timing thereof; and, the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  23. XEN1101 Phase 2b "X-TOLE" Clinical Trial in Adult Focal Epilepsy on Track for Topline Data in Third Quarter of 2021

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, March 01, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the year ended December 31, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "With two of our most advanced proprietary product candidates – XEN1101 and XEN496 – currently in Phase 2 and Phase 3 clinical trials, as well as a number of earlier stage clinical and non-clinical epilepsy assets in development, we believe Xenon is advancing one of the most robust…

    XEN1101 Phase 2b "X-TOLE" Clinical Trial in Adult Focal Epilepsy on Track for Topline Data in Third Quarter of 2021

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, March 01, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the year ended December 31, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "With two of our most advanced proprietary product candidates – XEN1101 and XEN496 – currently in Phase 2 and Phase 3 clinical trials, as well as a number of earlier stage clinical and non-clinical epilepsy assets in development, we believe Xenon is advancing one of the most robust epilepsy pipelines in the biopharmaceutical industry. Our focus remains on driving towards the topline data readout expected in the third quarter of this year from our Phase 2b ‘X-TOLE' clinical trial examining the use of XEN1101 in adult focal epilepsy."

    Mr. Ian Mortimer, Xenon's President and Chief Financial Officer added, "We were excited to present new pre-clinical data and provide a clinical overview of our XEN1101 program at the ASENT 2021 meeting last week. These presentations highlighted our belief that XEN1101 has key "ease-of-use" attributes that could meaningfully differentiate XEN1101 from other anti-seizure medications currently used to treat adult focal epilepsy. Additionally, we announced that we intend to support the initiation of a Phase 2 proof-of-concept clinical trial in 2021 with academic collaborators at the Icahn School of Medicine at Mount Sinai examining XEN1101 in major depressive disorder and anhedonia."

    Highlights and Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, Xenon's "X-TOLE" study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Xenon anticipates that patient randomization will be completed in the first half of 2021, with topline data anticipated in the third quarter of 2021, dependent upon ongoing patient enrollment rates. At ASENT 2021, the virtual annual meeting of the American Society for Experimental Neurotherapeutics, Xenon presented new pre-clinical data combining XEN1101 with commercially approved anti-seizure medications (ASMs) – including lacosamide, levetiracetam, cenobamate, phenytoin, and valproic acid – showing that combining sub-efficacious doses of XEN1101 and other ASMs provided robust efficacy in animal models. This pre-clinical work suggests that XEN1101 may be well suited for use as a monotherapy or applied in a rational polypharmacy setting to treat seizures. Additional pre-clinical data were presented that support the potential benefit of XEN1101 to treat depression and anhedonia. Xenon expects to support the initiation of a Phase 2 proof-of-concept clinical trial in 2021 with academic collaborators at the Icahn School of Medicine at Mount Sinai examining XEN1101 in major depressive disorder and anhedonia.



    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Xenon has received Fast Track designation and Orphan Drug Designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE from the U.S. Food and Drug Administration (FDA), as well as orphan medicinal product designation from the European Commission. Xenon has initiated a Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial, called the "EPIK" study, evaluating the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE.



    • XEN007 (active ingredient flunarizine) is a CNS-acting Cav2.1 and T-type calcium channel modulator that is being studied in treatment-resistant childhood absence epilepsy (CAE) and potentially other neurological disorders. A physician-led, Phase 2 proof-of-concept study is ongoing to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant CAE. A presentation of promising interim data collected from a small number of patients was presented at the virtual annual meeting of the American Epilepsy Society in December 2020. Given the impact of COVID-19 on recruitment, Xenon continues to work with its collaborator to expand the study to include additional sites and expects that topline results from a larger data set will now be available in the second half of 2021. Xenon expects to make a decision in 2021 regarding the future development of XEN007 in CAE.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in SCN8A-DEE patients. Based on this feedback, Neurocrine Biosciences anticipates initiating a Phase 2 clinical trial in adolescent patients (aged 12 years and older) with SCN8A-DEE in the third quarter of 2021, and the trial protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. In parallel, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy and expects to initiate a Phase 2 clinical trial in 2021. Upon IND or equivalent regulatory acceptance for NBI-921352 in adult focal epilepsy, Xenon is eligible to receive a $10.0 million milestone payment; upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, Xenon is eligible to receive a $25.0 million milestone payment, or a $15.0 million milestone payment if the IND acceptance for adult focal epilepsy occurs first. Both milestone payments are in the form of 45% cash and a 55% equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.



    • Flexion Therapeutics acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. In February 2021, the FDA cleared an IND for FX301, resulting in a $1.0 million milestone payment due to Xenon, and Flexion anticipates initiating a Phase 1b proof-of-concept clinical trial of popliteal fossa block with FX301 in patients undergoing bunionectomy in the first half of 2021. Topline results from that trial could potentially be available in late 2021. Pursuant to the terms of the agreement, Xenon is eligible to receive up to an additional $7.0 million in milestone payments through initiation of a Phase 2 clinical trial.

    Corporate Highlights

    • On February 23, 2021, Dr. Ernesto Aycardi resigned as the Company's Chief Medical Officer, effective April 23, 2021, to pursue another opportunity leading global development for a pharmaceutical company. Xenon is pleased to announce that it has engaged Dr. Kenneth Sommerville to serve as Interim Chief Medical Officer. Dr. Sommerville is a board-certified neurologist, who has over 20 years of experience in the pharmaceutical industry, including positions at Abbott Pharmaceuticals, GW Pharmaceuticals, Pfizer, Inc., King Pharmaceuticals, UCB, and Schwarz Pharma. He has led Phase 2 and Phase 3 epilepsy trials in the U.S. and made major contributions to multiple successful NDA submissions. He is recognized as a leader in neurology drug development, with a particular focus on anti-epileptic drugs, pain, Parkinson's disease, and abuse-deterrent opioids. He was Adjunct Assistant Professor of Medicine of the Duke University Medical School until June 2019 and was in the private practice of neurology for 11 years (1980-1991) prior to entering the pharmaceutical industry.

    Dr. Pimstone commented, "On behalf of the Xenon team, we wish our Chief Medical Officer Dr. Ernesto Aycardi well in his future endeavors as he pursues an opportunity to lead global development for a pharmaceutical company, and we are grateful for his many contributions to our clinical programs. We expect a smooth transition as Ernesto will be staying on with Xenon until late April, by which time we will have concluded patient screening in our XEN1101 X-TOLE study. We are delighted to announce that we have engaged Dr. Kenneth Sommerville to serve as Xenon's interim Chief Medical Officer. We believe Ken is one of the most experienced epilepsy drug developers in the pharmaceutical industry, with more than 20 years of experience in both orphan and larger market indications. In addition to leading the development of Epidiolex to a successful NDA submission for GW Pharmaceuticals, Ken was highly involved in the clinical development of sodium valproate, tiagabine, and lacosamide."

    Dr. Ken Sommerville said, "Xenon's broad pipeline of epilepsy drugs with novel, differentiated mechanisms has the potential to improve patient outcomes. Based on the encouraging data generated to date, I am looking forward to the important clinical read-out from the X-TOLE study, as well as supporting the advancement of other clinical programs within Xenon's portfolio."

    2020 Financial Results

    Cash and cash equivalents and marketable securities as of December 31, 2020 were $177.0 million, compared to $141.4 million as of December 31, 2019. There were 35,012,125 common shares and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations, outstanding as of December 31, 2020.

    Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2023, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the year ended December 31, 2020, Xenon reported total revenue of $32.2 million, compared to $6.8 million for the same period in 2019. The increase was attributable to the recognition of $26.8 million of deferred revenue as well as $5.4 million for research and development services from the license and collaboration agreement with Neurocrine Biosciences, compared to $2.9 and $0.4 million, respectively, in the comparable period. Revenue for the year ended December 31, 2019 also included $3.5 million in connection with the agreement with Flexion.

    Research and development expenses for the year ended December 31, 2020 were $50.5 million, compared to $38.8 million for the same period in 2019. The increase of $11.7 million was primarily attributable to increased spending on Xenon's clinical development product candidates XEN1101 and XEN496, and, to a lesser extent, increased spending on pre-clinical, discovery and other internal programs. This was partially offset by decreased spending on XEN901, now known as NBI-921352, as clinical development costs are borne by Neurocrine Biosciences.

    General and administrative expenses for the year ended December 31, 2020 were $12.9 million compared to $10.8 million for the same period in 2019. The increase of $2.1 million was primarily attributable to increased stock-based compensation expense, insurance premiums and salaries and benefits, partially offset by a decrease in legal fees for intellectual property protection.

    Other income for the year ended December 31, 2020 was $2.2 million compared to $1.2 million for the same period in 2019. The increase was primarily attributable to an increase in foreign exchange gains largely from the translation of cash and cash equivalents and marketable securities denominated in Canadian dollars to U.S. dollars.

    Net loss for the year ended December 31, 2020 was $28.8 million, compared to $41.6 million for the same period in 2019. The change was primarily attributable to revenue recognized in the year pursuant to the license and collaboration agreement with Neurocrine Biosciences, partially offset by higher research and development expenses as compared to the same period in 2019.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the year-end results and to provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 6061326.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the expansion of the X-TOLE clinical trial and the anticipated timing of the topline data therefrom; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2023; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

     
    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Balance Sheets

    (Expressed in thousands of U.S. dollars)
         
      December 31,  December 31,
     2020  2019
    Assets      
    Current assets:      
    Cash and cash equivalents and marketable securities$176,997  $141,358
    Other current assets 4,786   3,508
    Other assets 7,403   2,831
    Total assets$189,186  $147,697
           
    Liabilities      
    Current liabilities:      
    Accounts payable and accrued expenses 10,874   8,818
    Deferred revenue 3,642   29,743
    Term loan    4,650
    Other current liabilities 265   168
    Other liabilities 3,050   12,341
    Total liabilities$17,831  $55,720
           
    Shareholders' equity$171,355  $91,977
    Total liabilities and shareholders' equity$189,186  $147,697



       
    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Statements of Operations

    (Expressed in thousands of U.S. dollars except share and per share amounts)
       
     Year Ended December 31, 
     2020  2019 
    Revenue$32,166  $6,829 
            
    Operating expenses:       
    Research and development 50,523   38,845 
    General and administrative 12,944   10,803 
    Total operating expenses 63,467   49,648 
    Loss from operations (31,301)  (42,819)
    Other income 2,207   1,201 
    Loss before income taxes (29,094)  (41,618)
    Income tax recovery 257   23 
    Net loss and comprehensive loss (28,837)  (41,595)
    Net loss attributable to preferred shareholders (824)  (1,568)
    Net loss attributable to common shareholders$(28,013) $(40,027)
            
    Net loss per common share:       
    Basic and diluted$(0.81) $(1.54)
    Weighted-average common shares outstanding:       
    Basic and diluted 34,542,213   25,939,405 



    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  24. BURNABY, British Columbia, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced it will report its 2020 financial and operating results after the close of U.S. financial markets on Monday, March 1, 2021:

    • Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) on Monday, March 1, 2021 to discuss the year-end results and to provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 6061326.

    In addition, Xenon will participate…

    BURNABY, British Columbia, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced it will report its 2020 financial and operating results after the close of U.S. financial markets on Monday, March 1, 2021:

    • Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) on Monday, March 1, 2021 to discuss the year-end results and to provide a corporate update. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 6061326.

    In addition, Xenon will participate in a fireside discussion at the following upcoming virtual investor conference, which will be webcast live on the Investors section of the Xenon website:

    • SVB Leerink 10th Annual Global Healthcare Conference at 10:00 am Eastern Time on Wednesday, February 24, 2021.

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at www.xenon-pharma.com. When available, webcasts will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  25. Pre-Clinical Data Support the Potential Benefit of XEN1101 to Treat Depression and Anhedonia

    XEN1101, in Combination with Other Anti-Seizure Medications, Provides Robust Efficacy in Animal Models

    Topline Data from XEN1101 Phase 2b X-TOLE Clinical Trial in Adult Focal Epilepsy on Track for Third Quarter of 2021

    BURNABY, British Columbia, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, announced that new pre-clinical data and a clinical overview of its XEN1101 program will be presented at ASENT 2021, the virtual annual meeting of the American Society for Experimental Neurotherapeutics. XEN1101 is a differentiated Kv7 potassium channel modulator being developed for…

    Pre-Clinical Data Support the Potential Benefit of XEN1101 to Treat Depression and Anhedonia

    XEN1101, in Combination with Other Anti-Seizure Medications, Provides Robust Efficacy in Animal Models

    Topline Data from XEN1101 Phase 2b X-TOLE Clinical Trial in Adult Focal Epilepsy on Track for Third Quarter of 2021

    BURNABY, British Columbia, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, announced that new pre-clinical data and a clinical overview of its XEN1101 program will be presented at ASENT 2021, the virtual annual meeting of the American Society for Experimental Neurotherapeutics. XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. The X-TOLE Phase 2b clinical trial is currently underway studying the efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy.

    Today, Xenon hosted a symposium presentation entitled, "Addressing an Unmet Medical Need in Adult Focal Epilepsy with XEN1101, a Novel Kv7 Modulator," which provided an update on XEN1101's clinical development to date and outlined a number of its unique pharmaceutical properties including:

    • Proven anti-seizure Kv mechanism of action
    • Efficacious as monotherapy and in combination with other anti-seizure medications (ASMs) in pre-clinical models
    • Well-tolerated in Phase 1 clinical studies, and low drop-out and high conversion to open label extension in blinded Phase 2b clinical trial to date
    • Once daily (QD) evening dosing, low daily dose and no dose titration in ongoing Phase 2b clinical trial
    • No significant drug-drug-interactions (DDI) predicted

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, stated, "Our presentations at ASENT 2021 summarize our view that XEN1101 could potentially represent a highly differentiated profile in the focal epilepsy space with important "ease-of use" attributes that we believe are meaningful for physicians and patients combined with a favorable safety/tolerability profile to date. We are looking forward to the read-out of topline results from our ongoing Phase 2b X-TOLE clinical trial, anticipated in the third quarter of this year."

    Other presentations at ASENT 2021 include:

    • A pipeline presentation entitled "Anticonvulsant Effects of the Differentiated Kv7 Channel Potentiator XEN1101 in Combination with Commonly Used Anti-Seizure Drugs" includes new pre-clinical data showing that combining sub-efficacious doses of XEN1101 and other ASMs provided robust efficacy in animal models, which was not an apparent DDI effect. In addition, the combination dosing was well tolerated in the dose ranges explored. This work suggests that XEN1101 may be well suited for use as a monotherapy or applied in a rational polypharmacy setting to treat seizures. Data were presented combining XEN1101 with commercially approved ASMs, including lacosamide, levetiracetam, cenobamate, phenytoin, and valproic acid.



    • A symposium presentation entitled, "Kv7 Modulators in Epilepsy and Depression" outlines the scientific rationale, pre-clinical data, and clinical work to date supporting the use of Kv7 modulators for the treatment of depression and anhedonia. Pre-clinical work demonstrates a regulatory role for the KCNQ-type potassium channels in reversing depressive phenotypes following social defeat stress. Results from clinical studies using the first generation, Kv7 potassium channel modulator, ezogabine, supported the hypothesis that increasing KCNQ channel signaling can be beneficial for patients with depression and anhedonia. Major depression is a common co-morbidity of persons with epilepsy and significantly impacts their quality of life.



    • A pipeline presentation entitled "Depression and Anhedonia: Acute Pre-clinical Efficacy for XEN1101, a Differentiated Kv7 Potassium Channel Modulator" included new pre-clinical data from the Forced Swim Test and Progressive Ratio Test animal models, which support a potential benefit of XEN1101 in mood disorders. Of note, the efficacious doses and plasma concentrations from the pre-clinical depression, anhedonia, and seizure studies overlap and occur at plasma levels achieved during a multi-ascending Phase 1 clinical trial suggesting that the current doses being used in the ongoing XEN1101 Phase 2b clinical trial to treat epilepsy may have a beneficial impact on depressed mood.

    Mr. Ian Mortimer, Xenon's President and Chief Financial Officer said, "In addition to the ongoing clinical development of our XEN1101 Phase 2b X-TOLE study in adult focal epilepsy, we have been exploring the use of XEN1101 in other non-epilepsy indications. Based on our analysis and these promising pre-clinical data, we expect to initiate a Phase 2 proof-of-concept clinical trial this year examining XEN1101 in major depressive disorder (MDD) and anhedonia in partnership with academic collaborators at the Icahn School of Medicine at Mount Sinai. We look forward to updating you with further details in the coming months."

    All of Xenon's presentations at ASENT 2021 will be made available on the Xenon website.

    Scientific Rationale for Studying XEN1101 in MDD

    In addition to the supporting evidence presented at ASENT 2021, previous pre-clinical work demonstrates a regulatory role for the KCNQ-type potassium channels in reversing depressive phenotypes following social defeat stress (Krishnan et al. 2007; Friedman et al. 2014; Friedman et al. 2016). Mice resilient to depression and anhedonia exhibit increased KCNQ channel activity within the ventral tegmental area (VTA), dampening the hyperexcitability of the dopamine neurons that is associated with depressive/anhedonia phenotypes observed in the susceptible mice. This susceptible phenotype can be reversed through (a) overexpression of KCNQ channels in the VTA dopamine neurons, (b) direct intra-VTA injection of KCNQ channel openers, or (c) systemic injection of KCNQ channel openers. Repeated peripheral daily administration of the KCNQ channel opener ezogabine completely reversed the depressive/anhedonic phenotype in the susceptible mice. XEN1101, a next-generation, more potent KCNQ channel opener, has been shown to be effective in several in vivo rodent models of electrically and chemically induced seizures and exhibits a selectivity for Kv7 channels over other ion channels and receptors. Moreover, XEN1101 was found to be relatively more selective for Kv7.2/7.3 over Kv7.3/7.5 and Kv7.4 channels, relevant for the efficacy and safety profile of the drug. In vitro studies suggested a low potential for drug-drug interactions through the inhibition of the cytochrome isoenzymes, and data from Phase 1 clinical studies showed a favorable pharmacokinetic profile. In addition, an open-label, proof-of-concept clinical study was conducted with eighteen medication-free individuals with MDD in a major depressive episode (MDE) who received ezogabine up to 900 mg/day orally (within the approved range for seizure disorder) over the course of ten weeks. After treatment with ezogabine, subjects exhibited a significant reduction of depressive symptoms MADRS score change: −13.7±9.7, p<0.001, d=2.08 and anhedonic symptoms (Snaith-Hamilton Pleasure Scale (SHAPS) score change: −6.1±5.3, p<0.001, d=1.00), which remained significant even after controlling for overall depression severity. (Tan et al 2018).

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN1101; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN1101; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN1101; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN1101 proprietary development program; the timing and results of our interactions with regulators; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; promising results from trials involving a small number of patients may not be replicated in subsequent, larger trials; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

     



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  26. Simon Pimstone to Assume New Role as Executive Chair and Ian Mortimer to be Named Chief Executive Officer at Annual Meeting of Shareholders in June 2021

    Topline Data from XEN1101 Phase 2b X-TOLE Clinical Trial in Adult Focal Epilepsy on Track for Third Quarter of 2021

    Phase 3 XEN496 "EPIK" Clinical Trial Initiated in Patients with KCNQ2-DEE, a Rare Orphan Pediatric Disease

    BURNABY, British Columbia, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today outlined its key milestone opportunities and plans for a leadership transition in 2021, with all changes anticipated to take effect in June 2021 at the time of the Company's annual meeting of shareholders. As part…

    Simon Pimstone to Assume New Role as Executive Chair and Ian Mortimer to be Named Chief Executive Officer at Annual Meeting of Shareholders in June 2021

    Topline Data from XEN1101 Phase 2b X-TOLE Clinical Trial in Adult Focal Epilepsy on Track for Third Quarter of 2021

    Phase 3 XEN496 "EPIK" Clinical Trial Initiated in Patients with KCNQ2-DEE, a Rare Orphan Pediatric Disease

    BURNABY, British Columbia, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today outlined its key milestone opportunities and plans for a leadership transition in 2021, with all changes anticipated to take effect in June 2021 at the time of the Company's annual meeting of shareholders. As part of the leadership transition, Dr. Simon Pimstone, Xenon's co-founder and Chief Executive Officer, will step down from his current role as Chief Executive Officer and assume the new role of Executive Chair of the Board of Directors, replacing Mr. Michael Tarnow, current Chair of the Board, who will not be standing for re-election at the 2021 annual meeting of shareholders. Mr. Ian Mortimer, who currently serves as President and Chief Financial Officer, will be appointed as President and Chief Executive Officer and will also be nominated for election as a director at the 2021 annual meeting of shareholders. Concurrent with these appointments, Ms. Sherry Aulin, Xenon's current Vice President, Finance, will be appointed Chief Financial Officer, and Ms. Dawn Svoronos will be appointed Lead Independent Director of the Board.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, stated, "As co-founder of Xenon, I am proud of Xenon's immense progress over the years, resulting in one of the most robust and novel neurology-focused therapeutic pipelines in our industry. I have forged a strong partnership with Ian, who has been integral to Xenon's growth and a key strategic partner in building our company and pipeline, as well as our strong balance sheet. Xenon is in excellent shape and, as a founder and long-time CEO, this is a natural leadership transition that will allow me to focus on a strategic role while continuing to work closely with Ian and the rest of the leadership team as we execute on Xenon's plans for the continued advancement of our pipeline programs. In addition, I want to extend my deep gratitude to Michael Tarnow for his more than 20 years of service as a member of Xenon's Board since the company's inception. We have all benefitted immensely from Michael's guidance, leadership and mentorship as Board Chair."

    Mr. Ian Mortimer, Xenon's President and Chief Financial Officer said, "It is Simon's vision and drive that has helped position Xenon today as a premier neuroscience company focused on developing and delivering innovative medicines to improve the health of patients with epilepsy and other neurological disorders. We have attracted top talent across our business while building a strong leadership team, and I am excited to take on this new role as we work together to advance our therapeutic programs into later-stage development."

    Dr. Pimstone and Mr. Mortimer jointly stated, "Looking ahead to 2021, we anticipate a number of key milestone events. Importantly, we expect a topline read-out in the third quarter from our XEN1101 Phase 2b X-TOLE study. Given its unique mechanism of action and other key pharmaceutical attributes, we believe XEN1101 has the opportunity to be an important new therapeutic choice in the adult focal epilepsy space. In addition, we have now initiated our Phase 3 EPIK clinical trial studying XEN496 in pediatric patients with KCNQ2-DEE and continue to work with the KCNQ2 community to develop a therapeutic that could address this rare, pediatric disorder. By mid-year, we expect additional data from a physician-led study examining the use of XEN007 to treat childhood absence epilepsy. We also anticipate a number of important milestone events from our partnered programs, including the initiation of a Phase 2 clinical trial with NBI-921352, related to our collaboration with Neurocrine Biosciences focused on developing treatments for epilepsy. Coming out of our partnered program with Flexion Therapeutics, we expect clinical development to start in 2021, examining the use of FX301 for the treatment of post-operative pain."

    Highlights and Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, Xenon's "X-TOLE" study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Xenon anticipates that patient randomization will be completed in the first half of 2021, with topline data anticipated in the third quarter of 2021, dependent upon ongoing patient enrollment rates. In addition, Xenon expects to support the initiation of a Phase 2 proof-of-concept clinical trial examining XEN1101 in a non-epilepsy indication within the first half of 2021.



    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Xenon has received Fast Track designation and Orphan Drug Designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE from the U.S. Food and Drug Administration (FDA), as well as an orphan medicinal product designation in Europe. Xenon has initiated a Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial, called the "EPIK" study, evaluating the efficacy, safety, and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE.



    • XEN007 (active ingredient flunarizine) is a CNS-acting Cav2.1 and T-type calcium channel modulator that is being studied in treatment-resistant childhood absence epilepsy (CAE) and potentially other neurological disorders. A physician-led, Phase 2 proof-of-concept study is ongoing to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant CAE. A presentation of promising interim data collected from a small number of patients was presented at the virtual annual meeting of the American Epilepsy Society in December 2020. Xenon continues to work with its collaborators and expects that topline results from a larger data set will be available by the middle of 2021. Depending on the final results, CAE may represent a potential orphan indication for future development of XEN007.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in SCN8A-DEE patients. Based on this feedback, Neurocrine Biosciences anticipates initiating a Phase 2 clinical trial in adolescent patients (aged 12 years and older) with SCN8A-DEE in the third quarter of 2021, and the trial protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information. In parallel, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy and expects to initiate a Phase 2 clinical trial in 2021. Upon IND or equivalent regulatory acceptance for NBI-921352 in adult focal epilepsy, Xenon is eligible to receive a $10.0 million milestone payment; upon FDA acceptance of a protocol amendment for NBI-921352 in pediatric patients (aged 2-11 years) with SCN8A-DEE, Xenon is eligible to receive a $25.0 million milestone payment, or a $15.0 million milestone payment if the IND acceptance for adult focal epilepsy occurs first. Both milestone payments are in the form of 45% cash and a 55% equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.



    • Flexion Therapeutics, Inc. acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's pre-clinical FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion anticipates filing an IND application in the first half of 2021 to support a proof-of-concept clinical trial of popliteal fossa block with FX301 in patients undergoing bunionectomy. Results from that trial could potentially be available in late 2021. Pursuant to the terms of the agreement, Xenon is eligible to receive up to an additional $8.0 million in milestone payments through initiation of a Phase 2 clinical trial.

    Corporate Highlights

    • In addition to the planned leadership transition described above, the Board appointed Mr. Patrick Machado to the Audit Committee of the Board on January 12, 2021, effective immediately.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and impact of anticipated leadership changes; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; promising results from trials involving a small number of patients may not be replicated in subsequent, larger trials; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com 



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  27. BURNABY, British Columbia, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, announced updates on its proprietary and partnered neurology programs at AES2020, the virtual Annual Meeting of the American Epilepsy Society.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to make exciting advances as both our proprietary and partnered neurology pipeline candidates progress into mid- to late-stage clinical development. Presentations related to Xenon's proprietary programs, XEN1101 and XEN496, as well as our partnered program with Neurocrine, are scheduled in a number of poster sessions at AES2020. In addition, we continue to work with our collaborators…

    BURNABY, British Columbia, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, announced updates on its proprietary and partnered neurology programs at AES2020, the virtual Annual Meeting of the American Epilepsy Society.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to make exciting advances as both our proprietary and partnered neurology pipeline candidates progress into mid- to late-stage clinical development. Presentations related to Xenon's proprietary programs, XEN1101 and XEN496, as well as our partnered program with Neurocrine, are scheduled in a number of poster sessions at AES2020. In addition, we continue to work with our collaborators who are conducting a Phase 2 physician-led study examining the potential of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy, or CAE. Interim data from the ongoing XEN007 CAE study with a small number of patients are very promising, with all three CAE subjects having completed their maintenance phase of dosing and exhibiting a significant reduction in seizures as measured by seizure diary and confirmed by EEG. We expect topline results from a larger data set will be available by the middle of next year."

    Dr. Mary Connolly, Principal Investigator and Director of the Epilepsy Program at BC Children's Hospital, stated, "We are excited by these preliminary results, which showed that treating CAE patients with XEN007 showed a greater than 50% reduction in diary recorded seizures in all three CAE patients, with two of those patients showing a greater than 80% reduction. Our hope is that this study will generate useful data that support the development of XEN007 as a potential new therapeutic approach for CAE, especially for those who do not respond to the treatments currently available or who experience adverse effects which could be drug or dose limiting."

    Highlights from a poster entitled "Early Data from a Phase 2 Open Label Study of XEN007 (Flunarizine) for Treatment Resistant Absence Seizures" can be summarized as follows:

    • XEN007 was well tolerated and resulted in greater than 50% reduction in diary recorded seizures in all three CAE patients, with two showing greater than 80% reduction. EEGs for the three CAE subjects showed complete resolution of absence seizures for two subjects and 94% reduction for one.
    • There were two patients enrolled in the study with a different form of absence epilepsy, Jeavons Syndrome, who did not respond to XEN007. All future patient enrollment will focus on CAE given the promising responses seen to date.
    • XEN007 showed a good tolerability profile with no serious AEs noted.
    • This evidence suggests that XEN007 could be a meaningful treatment for treatment resistant CAE patients experiencing persistent absence seizures.

    All of Xenon's posters presented at AES2020 related to its proprietary programs will be made available on the Xenon website and include:

    • A poster entitled "Pre-clinical In Vitro and In Vivo Comparison of the Kv7 Activator XEN1101 with Ezogabine" presented pre-clinical data demonstrating that XEN1101 has a similar mechanism of action to ezogabine but potentially offers substantial improvements, including: more potent modulation of Kv7.2/Kv7.3; slowed deactivation of Kv7.2/7.3 channels to a greater degree, enhancing its ability to reduce hyper excitability; more potent anti-seizure activity in preclinical models; and no pigmented dimers and no predicted discoloration liability.
    • A poster entitled "Pharmacokinetic (PK) and Food Effect Assessment of XEN496, a Pediatric Formulation of Ezogabine, in Healthy Adults and Retrospective PK and Safety Comparison with Potiga®" presented data demonstrating that XEN496 was generally safe and well-tolerated and its overall PK profile was comparable to that of ezogabine.
    • A poster entitled "Selective Potentiation of Inhibitory Networks Prevents Seizures in a Mouse Model of Dravet Syndrome" presented pre-clinical data that suggests brain penetrant small molecule enhancers of Nav1.1 currents may represent a new, mechanistically differentiated, class of voltage-gated sodium channel potentiators with the potential to provide an improved therapeutic profile for the treatment of Dravet Syndrome.

    In addition, a number of posters were presented at AES2020 related to Xenon's ongoing collaboration with Neurocrine Biosciences, which has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy:

    • A poster entitled "An Online Survey of Caregivers for Patients with SCN8A Developmental and Epileptic Encephalopathy (SCN8A-DEE) or SCN8A-Related Epilepsy" concluded that patients with SCN8A-DEE or SCN8A-related epilepsy had high seizure burden, multiple neurologic and motor comorbidities, and inadequate treatment. The high proportion of patients who previously tried and stopped various medications indicated general dissatisfaction with current treatment options, suggesting ongoing unmet therapeutic needs in this heterogeneous patient population.



    • A poster entitled "Potential Drug-Drug Interactions Between NBI-921352/XEN901 (a Novel Nav1.6 Selective Sodium Channel Blocker) and a Strong Inducer of CYP3A4 (Phenytoin) in Healthy Volunteers" presented data from a study that evaluated the effect of phenytoin on the PK of NBI-921352 and concluded that there was no apparent impact on safety observed when NBI-921352 was co-administered with phenytoin.



    • A poster entitled "Pharmacokinetics, Food Effect, and Relative Bioavailability of Two Formulations of NBI-921352/XEN901 (Novel Nav1.6-Selective Sodium Channel Blocker) in Healthy Adults: Pediatric Granules and Adult Tablets" presented PK data that indicated that the pediatric granule formulation of NBI-921352 was bioequivalent to the immediate-release adult tablet after single-dose administration in the fasted state. In addition, the administration of the pediatric granule formulation of NBI-921352 in the fed state (with a high-fat meal) delayed the rate, but not the extent, of absorption when compared to the fasted state. The favorable PK of the pediatric formulation suggest this formulation is suitable for further clinical development of NBI-921352 in pediatric patients with SCN8A-DEE.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the potential to advance certain of our product candidates into later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; promising results from trials involving a small number of patients may not be replicated in subsequent, larger trials; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  28. BURNABY, British Columbia, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will participate in the following virtual investor conferences:

    • Guggenheim Healthcare 2nd Annual Neuro/Immunology Day on Monday, November 16, 2020
    • Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 4:40 pm ET
    • Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 9:40 am ET (2:40 pm GMT)

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at www.xenon-pharma.com. When…

    BURNABY, British Columbia, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will participate in the following virtual investor conferences:

    • Guggenheim Healthcare 2nd Annual Neuro/Immunology Day on Monday, November 16, 2020
    • Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 4:40 pm ET
    • Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 9:40 am ET (2:40 pm GMT)

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at www.xenon-pharma.com. When available, webcasts will be posted for replay following the event for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com



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  29. Experienced Biotech Executive, Patrick Machado, Joins Xenon's Board of Directors

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for its third quarter ended September 30, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to make good progress as we advance our proprietary neurology product candidates into mid- to late-stage clinical development despite the ongoing COVID-19 pandemic. We continue to manage our business prudently and are in a very sound financial position with cash, cash equivalents and marketable…

    Experienced Biotech Executive, Patrick Machado, Joins Xenon's Board of Directors

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported financial results for its third quarter ended September 30, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to make good progress as we advance our proprietary neurology product candidates into mid- to late-stage clinical development despite the ongoing COVID-19 pandemic. We continue to manage our business prudently and are in a very sound financial position with cash, cash equivalents and marketable securities of approximately $191 million and today extend our cash runway guidance into 2023. Within our ongoing XEN1101 Phase 2b X-TOLE study, we experienced a significant decrease in patient screening and randomization during the early stages of the COVID-19 pandemic. In response, we implemented several risk mitigation strategies that resulted more recently in a positive uptick in patient screening and randomization, although rates have yet to return to pre-COVID levels. We remain confident in the conduct of the study and integrity of the data as captured by electronic diary. We believe the positive effects of these additional measures will continue to materialize over the coming months and expect to complete all patient randomization for the X-TOLE trial in the first half of 2021, with topline data now expected in the third quarter of 2021."

    Dr. Pimstone continued, "In our XEN496 program, we also continued to make significant progress this past quarter. With the FDA having completed its review of our clinical trial protocol, we remain on track to initiate our Phase 3 EPIK clinical trial studying XEN496 in pediatric patients with KCNQ2-DEE prior to year-end. To support the upcoming EPIK study, we continue to work closely with the medical community, genetic testing companies, and patient advocacy groups to identify potential patients. While some factors, such as the impact of the COVID-19 pandemic, are outside of our direct control, we are committed to driving our proprietary neurology programs forward, with important milestone events anticipated in 2021."

    Dr. Pimstone added, "Today, we are also pleased to welcome Patrick Machado to our Board of Directors. Pat brings to Xenon a depth of biotech experience and track record of strong business leadership, having overseen finance, business development and legal functions over more than 20 years of an impressive career. I believe Pat will add tremendous value to our Board as we continue to advance multiple mid- to late-stage neurology-focused clinical development programs."

    Highlights and Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, Xenon's "X-TOLE" study is an ongoing Phase 2b clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Xenon is in close collaboration with each of the XEN1101 clinical sites in North America and Europe, taking specific direction from their respective clinical guidelines as they relate to new patient screening and randomization in the context of the COVID-19 pandemic. Xenon has expanded the X-TOLE clinical trial to include new sites in both existing and new jurisdictions to support increased patient screening. Xenon is updating its guidance to reflect the impact of COVID-19 on patient enrollment rates, and now anticipates that patient randomization will be completed in the first half of 2021, with topline data anticipated in the third quarter of 2021, dependent upon ongoing patient enrollment rates.
    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of epilepsy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) and Orphan Drug Designation (ODD) for the treatment of KCNQ2-DEE. In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. The FDA has completed its review of the clinical trial protocol, and Xenon expects to initiate its XEN496 Phase 3 "EPIK" clinical trial in pediatric patients with KCNQ2-DEE before year-end. This study is designed as a randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial to evaluate the efficacy, safety and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE. After screening, patients will enter a baseline period to assess the frequency of seizures. Eligible subjects will be randomized on a 1:1 basis to receive either XEN496 or placebo for approximately 15 weeks (titration and a 12-week maintenance period). At the end of treatment, there will be a period of tapering off of study drug, followed by a 28-day safety monitoring period. Patients may be considered for an open-label extension if they meet all requirements. The primary endpoint is the percent change from baseline in monthly countable motor seizure frequency during the blinded treatment period, as recorded by caregivers in a daily seizure diary. Key secondary endpoints include the proportion of patients experiencing greater than or equal to 50 percent reduction in monthly seizure frequency from baseline, caregiver global impression of change (CaGI-C) scores, and caregiver global impression of severity (CaGI-S) scores.
    • XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine, and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study is examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy, or CAE. A presentation of interim data collected from a small number of patients is expected to be presented in a poster presentation at "AES2020," the virtual annual meeting of the American Epilepsy Society to be held in December 2020. Xenon continues to work with its collaborators and expects that topline results from a larger data set will be available by the middle of next year. Depending on the final results, CAE may represent a potential orphan indication for future development of XEN007.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. The FDA has provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase 2 clinical trial in pediatric SCN8A-DEE patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. Neurocrine Biosciences and Xenon will engage with the FDA to address the feedback received with the goal of initiating a Phase 2 clinical trial in 2021. In parallel with this interaction, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy. Pursuant to the collaboration agreement, upon FDA acceptance of an IND for NBI-921352 in either SCN8A-DEE or a major indication, Xenon is eligible to receive a milestone payment of either $25 million or $10 million, respectively, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
    • Flexion Therapeutics, Inc. acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's pre-clinical FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion anticipates filing an IND application in the first half of 2021 to support a proof-of-concept clinical trial of popliteal fossa block with FX301 in patients undergoing bunionectomy. Results from that trial could potentially be available in late 2021.

    Corporate Highlights

    • Subsequent to quarter end, Xenon appointed Patrick Machado to its Board of Directors. Mr. Machado co-founded and served as Chief Financial Officer and Chief Business Officer at Medivation, Inc. until his retirement in 2014 and served as a member of Medivation's Board of Directors from 2014 until its acquisition for approximately $14 billion by Pfizer in 2016. During his tenure at Medivation, Mr. Machado helped lead the company through substantial growth and challenges, providing strong leadership during the clinical development and successful commercial launch of XTANDI®. Mr. Machado serves on multiple public company Boards, including as Chair of the Board of Directors of Adverum Biotechnologies, Inc., and as member of the Board of Directors of Arcus Biosciences, Inc., Turning Point Therapeutics and Chimerix, Inc. Additionally, Mr. Machado is a member of the Board of Directors of Armaron Bio Pty Ltd., Roivant Sciences Ltd., and Turnstone Biologics, all private companies. Earlier in his career, from 1998 to 2001, Mr. Machado worked with ProDuct Health, Inc., a medical device company as Senior Vice President, Chief Financial Officer, and earlier as General Counsel. Previously, Mr. Machado worked for Morrison & Foerster LLP, a leading international law firm, and for the Massachusetts Supreme Judicial Court. Mr. Machado received his J.D. degree from Harvard Law School and holds both a Bachelor of Science degree in Economics and a Bachelor of Arts degree in German from Santa Clara University in California.

    Third Quarter 2020 Financial Results

    Cash and cash equivalents and marketable securities as of September 30, 2020 were $190.9 million, compared to $141.4 million as of December 31, 2019. There were 34,994,946 common shares and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations, outstanding as of September 30, 2020.

    Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2023, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the quarter ended September 30, 2020, Xenon reported total revenue of $6.6 million, compared to $3.5 million for the same period in 2019. The increase of $3.1 million was attributable to the recognition of $5.2 million of deferred revenue as well as $1.3 million for research and development services from the license and collaboration agreement with Neurocrine Biosciences, compared to $3.5 million recognized in the comparative quarter in connection with the agreement entered into in September 2019 with Flexion.

    Research and development expenses for the quarter ended September 30, 2020 were $13.0 million, compared to $9.8 million for the same period in 2019. The increase was primarily attributable to increased spending on Xenon's clinical development product candidates XEN496 and XEN1101, and, to a lesser extent, increased spending on pre-clinical, discovery and other internal programs. This was partially offset by decreased spending on XEN901, now known as NBI-921352, as clinical development costs are borne by Neurocrine Biosciences.

    General and administrative expenses for the quarter ended September 30, 2020 were $3.2 million compared to $2.7 million for the same period in 2019. The increase of $0.5 million was primarily attributable to increased stock-based compensation expense, insurance premiums and salaries and benefits, partially offset by a decrease in legal fees for intellectual property protection.

    Other income for the quarter ended September 30, 2020 was $0.6 million compared to $0.1 million for the same period in 2019. The increase was primarily attributable to an increase in foreign exchange gains largely from the translation of cash and cash equivalents and marketable securities denominated in Canadian dollars to U.S. dollars and a decrease in interest expense due to the repayment of a term loan in May 2020, partially offset by a decrease in interest income.

    Net loss for the quarter ended September 30, 2020 was $8.9 million, consistent with $8.9 million for the same period in 2019.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its third quarter 2020 financial results and to provide a business update. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8125409. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the expansion of the X-TOLE clinical trial and the anticipated timing of the topline data therefrom; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2023; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.



    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Balance Sheets

    (Expressed in thousands of U.S. dollars)

      September 30,  December 31, 
      2020  2019 
    Assets        
    Current assets:        
    Cash and cash equivalents and marketable securities $190,927  $141,358 
    Other current assets  3,883   3,508 
    Other assets  4,318   2,831 
    Total assets $199,128  $147,697 
             
    Liabilities        
    Current liabilities:        
    Accounts payable and accrued expenses  8,875   8,818 
    Deferred revenue  7,446   29,743 
    Term loan     4,650 
    Other current liabilities  596   168 
    Other liabilities  188   12,341 
    Total liabilities $17,105  $55,720 
             
    Shareholders' equity $182,023  $91,977 
    Total liabilities and shareholders' equity $199,128  $147,697 



    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Statements of Operations

    (Expressed in thousands of U.S. dollars except share and per share amounts)

      Three Months Ended September 30,Nine Months Ended September 30, 
      2020  2019  2020  2019 
    Revenue $6,554  $3,500  $27,016  $3,500 
                     
    Operating expenses:                
    Research and development  13,045   9,751   35,556   27,093 
    General and administrative  3,208   2,700   9,838   7,628 
    Total operating expenses  16,253   12,451   45,394   34,721 
    Loss from operations  (9,699)  (8,951)  (18,378)  (31,221)
    Other income  641   85   1,621   1,015 
    Loss before income taxes  (9,058)  (8,866)  (16,757)  (30,206)
    Income tax (expense) recovery  203   (5)  243   (13)
    Net loss and comprehensive loss  (8,855)  (8,871)  (16,514)  (30,219)
    Net loss attributable to preferred shareholders  (250)  (336)  (474)  (1,146)
    Net loss attributable to common shareholders $(8,605) $(8,535) $(16,040) $(29,073)
                     
    Net loss per common share:                
    Basic and diluted $(0.25) $(0.33) $(0.47) $(1.13)
    Weighted-average common shares outstanding:                
    Basic and diluted  34,994,944   25,793,482   34,387,986   25,773,732 



    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

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  30. BURNABY, British Columbia, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it will report its third quarter 2020 financial and operating results after the close of U.S. financial markets on Thursday, November 5, 2020. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8125409. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available…

    BURNABY, British Columbia, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it will report its third quarter 2020 financial and operating results after the close of U.S. financial markets on Thursday, November 5, 2020. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8125409. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

    Primary Logo

    View Full Article Hide Full Article
  31. BURNABY, British Columbia, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today provided regulatory updates on its proprietary pediatric neurology program, XEN496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). With the U.S. Food and Drug Administration (FDA) having completed its review of the clinical trial protocol, Xenon is on track to initiate the XEN496 Phase 3 clinical trial in pediatric patients with KCNQ2-DEE before year-end.

    In addition, Xenon has received a positive opinion from the Committee…

    BURNABY, British Columbia, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today provided regulatory updates on its proprietary pediatric neurology program, XEN496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). With the U.S. Food and Drug Administration (FDA) having completed its review of the clinical trial protocol, Xenon is on track to initiate the XEN496 Phase 3 clinical trial in pediatric patients with KCNQ2-DEE before year-end.

    In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. This European designation is in addition to the FDA granting Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE as well as Orphan Drug Designation (ODD) for the treatment of KCNQ2-DEE.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "This marks an extremely important milestone for Xenon, with the first of our proprietary product candidates now poised to enter a pivotal Phase 3 clinical trial. With feedback from the FDA, pharmacokinetic data supportive of our proprietary pediatric formulation, and considerable progress made in site selection and other preparations, we are excited to move forward with our ‘EPIK' Phase 3 clinical trial studying XEN496 in pediatric patients with KCNQ2-DEE. In addition, receiving an orphan medicinal product designation for XEN496 in Europe underscores that KCNQ2-DEE is a severe, early onset epilepsy disorder and further validates Xenon's novel, ‘precision medicine' approach to develop treatments for pediatric epilepsies. We continue to work closely with the medical community, genetic testing companies, and patient advocacy groups to identify potential patients for our EPIK study, which we expect to initiate before year-end."

    The XEN496 Phase 3 "EPIK" clinical trial is titled "A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects with KCNQ2 Developmental and Epileptic Encephalopathy." This study is designed as a randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial to evaluate the efficacy, safety and tolerability of XEN496 administered as adjunctive treatment in approximately 40 pediatric patients aged one month to less than 6 years with KCNQ2-DEE. After screening, patients will enter a baseline period to assess the frequency of seizures. Eligible subjects will be randomized on a 1:1 basis to receive either XEN496 or placebo for approximately 15 weeks (titration and a 12-week maintenance period). At the end of treatment, there will be a period of tapering off of study drug, followed by a 28-day safety monitoring period. Patients may be considered for an open-label extension if they meet all requirements. The primary endpoint is the percent change from baseline in monthly countable motor seizure frequency during the blinded treatment period, as recorded by caregivers in a daily seizure diary. Key secondary endpoints include the proportion of patients experiencing greater than or equal to 50 percent reduction in monthly seizure frequency from baseline, caregiver global impression of change (CaGI-C) scores, and caregiver global impression of severity (CaGI-S) scores.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and other development activities; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496; the anticipated timing of the initiation of future clinical trials for XEN496; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496 development programs; the timing and results of our interactions with regulators; and anticipated enrollment in our clinical trials and the timing thereof. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of new or changing laws or regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

    Primary Logo

    View Full Article Hide Full Article
  32. U.S. Food and Drug Administration (FDA) Requests Additional Non-Clinical Data to Support Dose Justification Before Initiation of a Phase II Clinical Trial with NBI-921352 in Pediatric SCN8A-DEE Patients

    FDA Grants Rare Pediatric Disease Designation for NBI-921352 for the Treatment of SCN8A-DEE

    SAN DIEGO and BURNABY, British Columbia, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) and Xenon Pharmaceuticals Inc. (NASDAQ:XENE) today provided an update on the ongoing collaboration for the clinical development of NBI-921352, previously known as XEN901. Neurocrine Biosciences has an exclusive license to NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and…

    U.S. Food and Drug Administration (FDA) Requests Additional Non-Clinical Data to Support Dose Justification Before Initiation of a Phase II Clinical Trial with NBI-921352 in Pediatric SCN8A-DEE Patients

    FDA Grants Rare Pediatric Disease Designation for NBI-921352 for the Treatment of SCN8A-DEE

    SAN DIEGO and BURNABY, British Columbia, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) and Xenon Pharmaceuticals Inc. (NASDAQ:XENE) today provided an update on the ongoing collaboration for the clinical development of NBI-921352, previously known as XEN901. Neurocrine Biosciences has an exclusive license to NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE), a rare pediatric epilepsy, and other forms of epilepsy, including focal epilepsy. The U.S. Food and Drug Administration (FDA) provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase II clinical trial in pediatric SCN8A-DEE patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. Neurocrine Biosciences and Xenon will engage with the FDA to address the feedback received with the goal of initiating a Phase II clinical trial in 2021. In parallel with this interaction, Neurocrine Biosciences is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy. In addition, the FDA recently granted Rare Pediatric Disease Designation for NBI-921352 for the treatment of SCN8A-DEE.

    "We expect to engage with the FDA in the near term to discuss their request for additional non-clinical data to enable a pediatric trial in SCN8A-DEE patients. In parallel, we are continuing to develop plans to study NBI-921352 in patients with adult focal epilepsy. We are committed to working with the FDA to address their feedback in a timely manner, with the goal of initiating a Phase II pediatric clinical trial in 2021," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.

    "The recent Rare Pediatric Disease Designation from the FDA underscores that SCN8A-DEE is a devastating pediatric epilepsy, with a lack of approved treatments, that results in serious, life-threatening seizures and neurodevelopmental impairment, further validating our ‘precision medicine' approach to develop treatments for pediatric epilepsies. We are now working with the team at Neurocrine Biosciences to respond to the FDA's request for information and also to support the clinical development plans for NBI-921352 in adult focal epilepsy," said Dr. Simon Pimstone, Xenon's Chief Executive Officer.

    Pursuant to the Collaboration Agreement, upon FDA acceptance of an IND for NBI-921352 in either SCN8A-DEE or another major indication, Xenon is eligible to receive a milestone payment of either $25 million or $10 million, respectively, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    About Xenon Pharmaceuticals Inc.

    Xenon Pharmaceuticals is a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. Xenon is advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Neurocrine Biosciences Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our collaboration with Xenon Pharmaceuticals Inc., Neurocrine Biosciences' expectations with regard to its interactions and communications with the FDA, the timing of completion of our clinical, regulatory, and other development activities, and the potential to receive a priority review voucher. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; the impact of the COVID-19 pandemic and efforts to mitigate its spread on our business; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantines, shelter-in-place and similar government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our business operations and the business operations of the third parties on which we rely; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities related to our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our product candidates; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended June 30, 2020. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

    Xenon Pharmaceuticals' Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and other development activities, including those related to NBI-921352 and the other pre-clinical compounds covered by our collaboration with Neurocrine Biosciences; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of NBI-921352 and the other pre-clinical compounds covered by our collaboration with Neurocrine Biosciences; the anticipated initiation of future clinical trials for NBI-921352 and the other pre-clinical compounds covered by our collaboration with Neurocrine Biosciences; our ability to achieve milestones in our collaboration with Neurocrine Biosciences and our other development programs; and the timing and results of our and our collaborators' interactions with regulators. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our and our collaborators' business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Neurocrine Biosciences, Inc. Contacts:

    Navjot Rai (Media), 858-617-7623, media@neurocrine.com

    Todd Tushla (Investors), 858-617-7143, ir@neurocrine.com

    Xenon Pharmaceuticals Inc. Contact:

    Jodi Regts (Media and Investors), 604-484-3353, investors@xenon-pharma.com

    Primary Logo

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  33. BURNABY, British Columbia, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, announced today the appointment of Dr. Chris Von Seggern as Chief Commercial Officer, effective immediately. In this newly created role, Dr. Von Seggern will report to Dr. Simon Pimstone, Xenon's Chief Executive Officer, and oversee the commercial strategy and execution for Xenon's neurology-focused portfolio of therapeutics.

    Dr. Pimstone stated, "Chris brings a deep knowledge of the pharmaceutical sector and, in particular, the orphan disease space. We are entering an exciting period when we are advancing multiple therapeutic candidates within our innovative pipeline of epilepsy treatments…

    BURNABY, British Columbia, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, announced today the appointment of Dr. Chris Von Seggern as Chief Commercial Officer, effective immediately. In this newly created role, Dr. Von Seggern will report to Dr. Simon Pimstone, Xenon's Chief Executive Officer, and oversee the commercial strategy and execution for Xenon's neurology-focused portfolio of therapeutics.

    Dr. Pimstone stated, "Chris brings a deep knowledge of the pharmaceutical sector and, in particular, the orphan disease space. We are entering an exciting period when we are advancing multiple therapeutic candidates within our innovative pipeline of epilepsy treatments, so it is timely to add Chris' strengths and skillset to our leadership team as Chief Commercial Officer. Chris has provided key strategic input supporting the commercial launch of more than 25 successful drugs, and I am confident his expertise will help shape our strategy as our programs progress through late stage clinical development and prepare for commercialization."

    Dr. Von Seggern added, "I am excited to join the outstanding leadership team at Xenon, which has been built upon a foundation of highly differentiated, deep science. With one of the most innovative neuroscience pipelines in the biotech industry today, we have the potential to improve patient outcomes and, in some cases, apply a ‘first-ever' precision medicine approach to treat rare forms of pediatric epilepsy."

    Most recently, prior to joining Xenon, Dr. Von Seggern was a Partner at ClearView Healthcare Partners from 2011 to 2019, where he developed broad experience overseeing a range of commercial engagements involving multiple therapeutic areas as well as strategic due diligence on in-licensing and M&A opportunities. Through his tenure from 2008 to 2019 at ClearView, Dr. Von Seggern worked across the pharmaceutical sector with emphasis in orphan diseases and transformational technologies. From 2006 to 2008, Dr. Von Seggern served as a Consultant for Leerink Swann Strategic Advisors. Dr. Von Seggern began his career at the National Institutes of Health where he served as an AAAS Science Policy Fellow within the National Institute of Diabetes, Digestive, and Kidney Diseases from 2005 to 2006. While at the NIDDK, Dr. Von Seggern helped set strategic direction for the Institute focusing on diabetes research and translational medicine. Dr. Von Seggern received his Ph.D. in pharmacology and molecular sciences as well as his Master of Public Health from Johns Hopkins University School of Medicine. Dr. Von Seggern received his MBA from Northeastern University and he earned his B.S. in biochemistry and molecular biology from the Pennsylvania State University.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.



    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding our management and prospects; the progress and potential of our pipeline and ongoing development programs; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of our product candidates; and the anticipated contributions of our CCO and other members of management. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

    Primary Logo

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  34. XEN496 Phase 3 Protocol Submitted to FDA and Trial Initiation Anticipated in 2020

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported its financial results for second quarter ended June 30, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "Xenon continues to manage well as we respond to the global impacts of the COVID-19 pandemic. We are looking forward to a number of key milestone events during the next 12 months, including topline data from our XEN1101 Phase 2b clinical trial, the anticipated start of a Phase 3 clinical trial with XEN496, data…

    XEN496 Phase 3 Protocol Submitted to FDA and Trial Initiation Anticipated in 2020

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported its financial results for second quarter ended June 30, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "Xenon continues to manage well as we respond to the global impacts of the COVID-19 pandemic. We are looking forward to a number of key milestone events during the next 12 months, including topline data from our XEN1101 Phase 2b clinical trial, the anticipated start of a Phase 3 clinical trial with XEN496, data from our Phase 2 proof-of-concept trial with XEN007, and the initiation of a Phase 2 trial in our partnered program with Neurocrine."

    Dr. Pimstone continued, "We have now filed our XEN496 Phase 3 protocol with the FDA, having implemented the recommendations made by the agency in previous interactions, and we expect feedback in the near-term to support our plans to initiate this trial in KCNQ2-DEE patients this year. We also continue to advance our XEN1101 Phase 2b "X-TOLE" clinical trial currently underway in adult focal epilepsy with topline data expected in the first half of 2021 as previously guided, and we are exploring other potential indications for the novel Kv7 potassium channel modulator. Our collaborator, Neurocrine, anticipates filing an IND in the near-term supporting the initiation of a Phase 2 clinical trial examining NBI-921352 in patients with SCN8A-related epilepsy in the second half of this year."

    Dr. Pimstone added, "I am also very pleased to welcome Sheila Grant to our senior leadership team as Xenon's Senior Vice President, R&D Operations. Sheila has more than 20 years of senior-level experience in the pharmaceutical industry with responsibilities that have encompassed global regulatory, manufacturing and supply chain operations for multiple commercial-stage drugs registered in numerous countries. I am confident Sheila's expertise will support Xenon's growth and maturation as we advance our neurology programs into late stage clinical development and increase our focus on commercialization efforts."

    Highlights and Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, a Phase 2b clinical trial (called the X-TOLE study) is ongoing to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Xenon is in close collaboration with each of the XEN1101 clinical sites in North America and Europe, taking specific direction from their respective clinical guidelines as they relate to new patient screening and randomization in the context of the COVID-19 pandemic. Xenon is expanding the X-TOLE clinical trial to include new sites in both existing and new jurisdictions to support increased patient screening. Topline data is anticipated in the first half of 2021, dependent upon the impact of COVID-19 on patient enrollment rates. Xenon also continues to explore the development of XEN1101 in other neurological indications.

       
    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of epilepsy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) and Orphan Drug Designation (ODD) for the treatment of KCNQ2-DEE. Published case reports where physicians have used ezogabine in infants and young children with KCNQ2-DEE suggest that ezogabine may be efficacious in this often hard-to-treat population. The FDA has indicated that it is acceptable to study XEN496 in pediatric patients (from one month to less than six years old) diagnosed with KCNQ2-DEE, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in pediatric patients with KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. To support the planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE, Xenon completed a pharmacokinetic (PK) study testing its proprietary pediatric formulation (XEN496) in 24 healthy adult volunteers. The PK profile observed for XEN496 is comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves, which supports plans for Phase 3 development. The proposed trial design is a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN496 in approximately 40 pediatric patients with KCNQ2-DEE. The primary endpoint is expected to be the median percent change in seizure frequency from baseline compared to treatment period of active versus placebo. Xenon has filed the final clinical trial protocol with the FDA, and feedback is expected in the near-term. Xenon anticipates initiating the XEN496 Phase 3 clinical trial in 2020.

       
    • XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine, and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study is examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy, or CAE. Due to the impact of COVID-19 on clinical trial enrollment rates and specifically due to the closure of our investigator site for a number of months in Canada, the topline results from this study are now expected in the first half of 2021. Depending on the final results, CAE may represent a potential orphan indication for future development of XEN007.             

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. Neurocrine Biosciences has indicated that it anticipates filing an IND application with the FDA in the near-term in order to start a Phase 2 clinical trial in SCN8A-DEE patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.

       
    • Flexion Therapeutics, Inc. acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's pre-clinical FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion anticipates initiating human clinical trials in 2021.

    Corporate Update

    • Effective August 4, 2020, Ms. Sheila Grant joined Xenon's leadership team as Senior Vice President, R&D Operations reporting to the Chief Medical Officer. Since March 2013, Ms. Grant was Chief Operating Officer at Correvio Pharma Corp. (previously Cardiome Pharma Corp.), which was acquired by ADVANZ PHARMA Corp. Limited in May 2020. Previously, Ms. Grant was Cardiome's VP of Product Development, with the responsibility for the overall management of the vernakalant IV and oral programs. She oversaw the development of vernakalant from its initial pre-clinical studies through to commercialization. Ms. Grant's past roles at Cardiome included Vice President, Commercial Affairs and Director of Business & Clinical Development. Prior to joining Cardiome, Ms. Grant acted as business consultant to De Novo Enzyme Corporation and Coopers & Lybrand. Ms. Grant also worked in research, production, and quality assurance with Schering Agrochemicals U.K., Wellcome Biotechnologies U.K. and Serono Diagnostics U.K. respectively. Ms. Grant holds an MBA degree from Simon Fraser University and an MSc from the London School of Hygiene and Tropical Medicine.

    Second Quarter 2020 Financial Results

    Cash and cash equivalents and marketable securities as of June 30, 2020 were $202.8 million, compared to $141.4 million as of December 31, 2019. There were 34,994,790 common shares and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations, outstanding as of June 30, 2020.

    Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2022, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the quarter ended June 30, 2020, Xenon reported total revenue of $13.4 million related to recognition of $11.9 million of deferred revenue as well as $1.5 million for research and development services from the license and collaboration agreement with Neurocrine Biosciences. There was no revenue recognized for the same period in 2019.

    Research and development expenses for the quarter ended June 30, 2020 were $10.7 million, compared to $8.2 million for the same period in 2019. The increase of $2.5 million was primarily attributable to increased spending on Xenon's clinical development product candidates XEN496 and XEN1101, and, to a lesser extent, increased spending on pre-clinical, discovery and other internal program expenses. This was partially offset by decreased spending on XEN901, now known as NBI-921352, as clinical development costs are borne by Neurocrine Biosciences. 

    General and administrative expenses for the quarter ended June 30, 2020 were $3.3 million compared to $2.3 million for the same period in 2019. The increase of $1.0 million was primarily attributable to increased stock-based compensation expense, salaries and benefits, and insurance premiums, partially offset by a decrease in legal fees for intellectual property protection.

    Other income for the quarter ended June 30, 2020 of $0.4 million did not change significantly as compared to other income of $0.5 million for the same period in 2019.

    Net loss for the quarter ended June 30, 2020 was $0.2 million, compared to $10.0 million for the same period in 2019. The change was primarily attributable to revenue recognized in the quarter ended June 30, 2020 pursuant to the agreement with Neurocrine Biosciences, partially offset by an increase in research and development and general and administrative expenses as compared to the same period in 2019.

    At-the-Market Equity Offering

    Xenon also announced today that it has entered into an at-the-market equity offering sales agreement with Jefferies LLC and Stifel, Nicolaus & Company, Incorporated, under which Xenon may sell its common shares, from time-to-time, for up to $100.0 million in aggregate sales proceeds in "at-the-market" transactions. Sales of the common shares, if any, will only be conducted in the United States through the Nasdaq or another exchange at market prices. No sales of common shares will be made in Canada.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its second quarter 2020 financial results and to provide a business update. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 4056993. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the expansion of the X-TOLE clinical trial and the anticipated timing of the topline data therefrom; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2022; the timing of potential publication or presentation of future clinical data; and the sale of any common shares pursuant to the at-the-market equity offering, including the price, volume and timing of any distributions. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.



    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Balance Sheets

    (Expressed in thousands of U.S. dollars)

     June 30, December 31,
     2020 2019
    Assets     
    Current assets:     
    Cash and cash equivalents and marketable securities$202,754 $141,358
    Other current assets 4,256  3,508
    Other assets 3,666  2,831
    Total assets$210,676 $147,697
          
    Liabilities     
    Current liabilities:     
    Accounts payable and accrued expenses 7,769  8,818
    Deferred revenue 12,692  29,743
    Term loan   4,650
    Other current liabilities 594  168
    Other liabilities 323  12,341
    Total liabilities$21,378 $55,720
          
    Shareholders' equity$189,298 $91,977
    Total liabilities and shareholders' equity$210,676 $147,697

    

    XENON PHARMACEUTICALS INC.

    Condensed Consolidated Statements of Operations

    (Expressed in thousands of U.S. dollars except share and per share amounts)

      Three Months Ended June 30,Six Months Ended June 30,
     2020  2019  2020  2019 
    Revenue$13,384  $  $20,462  $ 
                    
    Operating expenses:               
    Research and development 10,720   8,205   22,511   17,342 
    General and administrative 3,310   2,307   6,630   4,928 
    Total operating expenses 14,030   10,512   29,141   22,270 
    Loss from operations (646)  (10,512)  (8,679)  (22,270)
    Other income 432   476   980   930 
    Loss before income taxes (214)  (10,036)  (7,699)  (21,340)
    Income tax (expense) recovery 39   29   40   (8)
    Net loss and comprehensive loss (175)  (10,007)  (7,659)  (21,348)
    Net loss attributable to preferred shareholders (5)  (380)  (222)  (810)
    Net loss attributable to common shareholders$(170) $(9,627) $(7,437) $(20,538)
                    
    Net loss per common share:               
    Basic and diluted$(0.00) $(0.37) $(0.22) $(0.80)
    Weighted-average common shares outstanding:               
    Basic 34,979,282   25,773,879   34,084,508   25,763,858 
    Diluted 34,979,282   25,775,559   34,084,508   25,763,858 

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

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  35. BURNABY, British Columbia, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will participate in the following virtual investor conferences:

    • William Blair Biotech Focus Conference 2020 | Panel 4: New Therapies Impacting the Epilepsy Treatment Landscape on Thursday, August 6, 2020 at 12:00 pm ET
       
    • 2020 Wedbush PacGrow Healthcare Conference on Tuesday, August 11, 2020 at 3:30 pm ET

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at www.xenon-pharma.com. All webcasts will be posted for…

    BURNABY, British Columbia, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will participate in the following virtual investor conferences:

    • William Blair Biotech Focus Conference 2020 | Panel 4: New Therapies Impacting the Epilepsy Treatment Landscape on Thursday, August 6, 2020 at 12:00 pm ET

       
    • 2020 Wedbush PacGrow Healthcare Conference on Tuesday, August 11, 2020 at 3:30 pm ET

    The above listed dates and times are subject to change. Details on company presentations and webcasts can be found on the "Investors" section of Xenon's website at www.xenon-pharma.com. All webcasts will be posted for replay following the event for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

    Primary Logo

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  36. BURNABY, British Columbia, July 30, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it will report its second quarter 2020 financial and operating results after the close of U.S. financial markets on Thursday, August 6, 2020. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 4056993. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available…

    BURNABY, British Columbia, July 30, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it will report its second quarter 2020 financial and operating results after the close of U.S. financial markets on Thursday, August 6, 2020. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 4056993. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the

    lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to

    address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:

    Jodi Regts

    Xenon Pharmaceuticals Inc.

    Phone: 604.484.3353

    Email: investors@xenon-pharma.com

    Primary Logo

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  37. BURNABY, British Columbia, June 01, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, announced today that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 2:30 pm Eastern time.

    A webcast will be available on the investors section of the Xenon website at http://investor.xenon-pharma.com and will be available for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline…

    BURNABY, British Columbia, June 01, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, announced today that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 2:30 pm Eastern time.

    A webcast will be available on the investors section of the Xenon website at http://investor.xenon-pharma.com and will be available for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

    Primary Logo

    View Full Article Hide Full Article
  38. Progress Reported in Both Proprietary and Partnered Neurology Clinical Programs 

    Additional FDA Feedback Supports Commencement of XEN496 Phase 3 Clinical Trial in 2020

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, May 21, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported its financial results for first quarter ended March 31, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "Despite the global impacts of the COVID-19 pandemic, I am pleased to report exciting progress in both our proprietary and partnered neurology programs. Over the next 12 months, we anticipate a number of important clinical and…

    Progress Reported in Both Proprietary and Partnered Neurology Clinical Programs 

    Additional FDA Feedback Supports Commencement of XEN496 Phase 3 Clinical Trial in 2020

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, May 21, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neurology-focused biopharmaceutical company, today reported its financial results for first quarter ended March 31, 2020 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "Despite the global impacts of the COVID-19 pandemic, I am pleased to report exciting progress in both our proprietary and partnered neurology programs. Over the next 12 months, we anticipate a number of important clinical and regulatory milestone events from our pipeline of innovative epilepsy treatments, and we are fortunate to have the cash runway to support our business objectives."

    Dr. Pimstone continued, "Looking specifically at our proprietary epilepsy programs, we anticipate top-line data in the first half of 2021 from the XEN1101 Phase 2b "X-TOLE" clinical trial currently underway in adult focal epilepsy, and we continue to analyze other potential clinical indications for this novel Kv7 potassium channel modulator. Importantly, over the past few months, we have also made great strides in advancing XEN496, which is our proprietary pediatric formulation of ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy. A recently completed pharmacokinetic study testing XEN496 in healthy adult volunteers demonstrates that XEN496 has similar absorption and elimination curves as the historical data for immediate release ezogabine tablets. Building on this encouraging PK data, we have also received recent FDA feedback on our XEN496 program and believe we have all the necessary input to initiate a double-blind, placebo-controlled Phase 3 clinical trial in approximately 40 pediatric patients with KCNQ2-DEE later this year."

    Dr. Pimstone added, "I am proud that our partnered programs also continue to advance through development providing opportunities for milestone payments. Our collaborator, Neurocrine Biosciences, expects to file an IND in mid-2020 in order to start a Phase 2 clinical trial for NBI-921352 in SCN8A-DEE pediatric patients. In addition, Flexion Therapeutics recently announced positive pre-clinical data for FX301, a Nav1.7 inhibitor being developed in an injectable long acting formulation for control of post-operative pain, and advanced FX301 into GLP toxicology studies."

    Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, a Phase 2b clinical trial (called the X-TOLE study) is ongoing to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Xenon continues to review blinded data from patients who have been treated to date in the X-TOLE trial in order to assess safety, tolerability, and discontinuations. To date, XEN1101 has been well-tolerated and the rate of discontinuations from the study are below what was modeled. In addition, more than 90% of subjects to date from the double-blind portion of the trial have rolled-over into the open-label extension phase. Therefore, based on analysis of the blinded safety data to date, Xenon does not expect the need to conduct an interim analysis, which was an option that would have allowed for re-sizing of lower dose groups or for other changes to the study if tolerability was different than modeled. In the context of the COVID-19 pandemic, Xenon is in close collaboration with each of the XEN1101 clinical sites in North America and Europe, taking specific direction from their respective clinical guidelines as they relate to new patient screening and randomization. Xenon's primary efforts are focused on patients currently enrolled in the study, either in the double-blind portion or in the open-label extension portion of the study, while making other necessary amendments in the study, including minimizing any in-person patient visits and making provisions for adequate study drug supplies to patients wherever possible, to ensure that data integrity is maintained. Xenon is expanding the X-TOLE clinical trial to include new sites in both existing and new jurisdictions to support enhanced patient screening as soon as the individual clinical trial sites deem it safe to do so. Topline data is anticipated in the first half of 2021, dependent upon patient enrollment rates, which may be impacted by the COVID-19 pandemic. Xenon also continues to explore the development of XEN1101 in other neurological indications.
       
    • XEN496, a Kv7 potassium channel modulator, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of epilepsy. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Fast Track designation for the investigation of XEN496 for the treatment of seizures related to KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). Published case reports where physicians have used ezogabine in infants and young children with KCNQ2-DEE suggest that ezogabine may be efficacious in this often hard-to-treat pediatric patient population. To support a planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE, Xenon recently completed a pharmacokinetic (PK) study testing its proprietary pediatric formulation (XEN496) in 24 healthy adult volunteers. Subjects were given a single 400 mg dose of XEN496 in either the fed or the fasted state. While the study was not designed to determine bioequivalence – given ezogabine is not available to use as a comparator – the PK profile observed for XEN496 supports the Phase 3 plans and appears to be comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves. Xenon recently received additional feedback from FDA on its Phase 3 program for XEN496. The FDA has indicated that it is acceptable to study XEN496 in infants and children up to six years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. Based on the FDA's feedback, Xenon anticipates initiating a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the clinical efficacy, safety, and tolerability of XEN496 in approximately 40 pediatric patients with KCNQ2-DEE. The primary endpoint is expected to be the median percent change in seizure frequency from baseline compared to treatment period of active versus placebo. The XEN496 Phase 3 clinical trial is expected to be initiated in 2020.
       
    • XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine, and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study is examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy, or CAE. Results from this Phase 2 study are expected in 2020, dependent upon patient enrollment rates given the ongoing COVID-19 pandemic. Depending on the final results, CAE may represent a potential orphan indication for future development of XEN007.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy. Neurocrine Biosciences has indicated that it anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A-DEE patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
       
    • Flexion Therapeutics, Inc. acquired the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor also known as funapide. Flexion's pre-clinical FX301 consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. In April 2020, Flexion presented new animal data in an ePoster presentation on the American Society of Regional Anesthesia and Acute Pain website that showed FX301 provided sustained, post-operative analgesic effect with no impairment in motor function compared to liposomal bupivacaine and placebo.  In addition, high local concentrations of funapide, the active ingredient in FX301, were measured at the site of administration for the duration of the study which is consistent with the creation of a depot providing controlled drug release. A GLP toxicology study with FX301 commenced in April 2020, triggering a $0.5 million milestone payment to Xenon. Flexion anticipates initiating human clinical trials in 2021.

    First Quarter 2020 Financial Results

    Cash and cash equivalents and marketable securities as of March 31, 2020 were $229.7 million, compared to $141.4 million as of December 31, 2019. There were 34,956,272 common shares and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations, outstanding as of March 31, 2020.

    Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2022, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the quarter ended March 31, 2020, Xenon reported total revenue of $7.1 million related to recognition of $5.8 million of deferred revenue as well as $1.2 million for research and development services from the license and collaboration agreement with Neurocrine Biosciences. There was no revenue recognized for the same period in 2019.

    Research and development expenses for the quarter ended March 31, 2020 were $11.8 million, compared to $9.1 million for the same period in 2019. The increase of $2.7 million was primarily attributable to increased spending on Xenon's clinical development product candidates XEN496 and XEN1101, and, to a lesser extent, increased spending on pre-clinical, discovery and other internal program expenses. This was partially offset by decreased spending on XEN901, now known as NBI-921352, as clinical development costs are borne by Neurocrine Biosciences. 

    General and administrative expenses for the quarter ended March 31, 2020 were $3.3 million, compared to $2.6 million for the same period in 2019. The increase of $0.7 million was primarily attributable to increased stock-based compensation expense, salaries and benefits, insurance premiums and business development expenses, partially offset by a decrease in legal fees for intellectual property protection.

    Other income for the quarter ended March 31, 2020 was $0.5 million, consistent with $0.5 million for the same period in 2019.

    Net loss for the quarter ended March 31, 2020 was $7.5 million, compared to $11.3 million for the same period in 2019. The change was primarily attributable to revenue recognized in the quarter ended March 31, 2020 pursuant to the agreement with Neurocrine Biosciences, partially offset by an increase in research and development and general and administrative expenses as compared to the same period in 2019.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its first quarter 2020 financial results and to provide a business update. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8385218. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2022; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.


    XENON PHARMACEUTICALS INC.
    Condensed Consolidated Balance Sheets
    (Expressed in thousands of U.S. dollars)

         March 31,     December 31,  
        2020     2019  
    Assets                
    Current assets:                
    Cash and cash equivalents and marketable securities   $ 229,671     $ 141,358  
    Other current assets     4,199       3,508  
    Other assets     3,173       2,831  
    Total assets   $ 237,043     $ 147,697  
                     
    Liabilities                
    Current liabilities:                
    Accounts payable and accrued expenses     8,084       8,818  
    Deferred revenue     24,608       29,743  
    Term loan     15,676       4,650  
    Other current liabilities     156       168  
    Other liabilities     541       12,341  
    Total liabilities   $ 49,065     $ 55,720  
                     
    Shareholders' equity   $ 187,978     $ 91,977  
    Total liabilities and shareholders' equity   $ 237,043     $ 147,697  



    XENON PHARMACEUTICALS INC.
    Condensed Consolidated Statements of Operations
    (Expressed in thousands of U.S. dollars except share and per share amounts)

         Three Months Ended March 31,  
        2020     2019  
    Revenue   $ 7,078        
                     
    Operating expenses:                
    Research and development   $ 11,791     $ 9,137  
    General and administrative     3,320       2,621  
    Total operating expenses     15,111       11,758  
    Loss from operations     (8,033 )     (11,758 )
    Other income     548       454  
    Loss before income taxes     (7,485 )     (11,304 )
    Income tax (expense) recovery     1       (37 )
    Net loss and comprehensive loss     (7,484 )     (11,341 )
    Net loss attributable to preferred shareholders     (222 )     (430 )
    Net loss attributable to common shareholders   $ (7,262 )   $ (10,911 )
                     
    Net loss per common share:                
    Basic and diluted   $ (0.22 )   $ (0.42 )
    Weighted-average common shares outstanding:                
    Basic and diluted     33,189,733       25,753,836  



    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  39. BURNABY, British Columbia, May 14, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that it will report its first quarter 2020 financial and operating results after the close of U.S. financial markets on Thursday, May 21, 2020.  Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8385218. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available…

    BURNABY, British Columbia, May 14, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that it will report its first quarter 2020 financial and operating results after the close of U.S. financial markets on Thursday, May 21, 2020.  Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8385218. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

     

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  40. BURNABY, British Columbia, March 31, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today provided a corporate update in the context of the developing situation with the COVID-19 pandemic.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "The safety of Xenon's employees and their families, as well as the healthcare professionals and patients involved in our clinical studies, is of the utmost importance to us. As we face an unprecedented health system crisis globally, we are focused on doing all we can at Xenon internally, in collaboration with our partners, and in our community to support the collective global public health initiatives to address the COVID-19 pandemic…

    BURNABY, British Columbia, March 31, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today provided a corporate update in the context of the developing situation with the COVID-19 pandemic.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "The safety of Xenon's employees and their families, as well as the healthcare professionals and patients involved in our clinical studies, is of the utmost importance to us. As we face an unprecedented health system crisis globally, we are focused on doing all we can at Xenon internally, in collaboration with our partners, and in our community to support the collective global public health initiatives to address the COVID-19 pandemic. Earlier this month, we implemented ‘work-from-home' measures, suspended all non-critical lab work, and ceased non-essential business travel. Within the community in British Columbia, Xenon is in active discussions to assist in building COVID-19 screening capacity and has spearheaded a local initiative to collect Personal Protective Equipment from non-hospital-based research laboratories and collate an inventory of lab equipment useful in COVID-19 testing. Xenon will continue to live by our mission, to put people first, and will continue to do whatever we can, to protect the health and well-being of our staff, their families, and our community."

    Dr. Pimstone stated, "Given the rapidly changing environment, we are providing a corporate update on our proprietary and partnered programs. At a high level, it's important to state that Xenon is in a very sound financial position. We have the benefit of a strong balance sheet and the resources to continue our work during this global public health crisis. Our cash, cash equivalents and marketable securities were approximately $235 million at the end of February 2020, which we anticipate provides us with sufficient cash to fund operations into 2022. We continue to make prudent business and spending decisions, with the flexibility to extend cash runway further if required, and are confident we have the necessary resources to manage through these unprecedented times."

    Dr. Pimstone continued, "Within our XEN1101 ‘X-TOLE' Phase 2b clinical trial, as with other trials ongoing in our industry, we are seeing a significant reduction in new patient enrollment for numerous reasons related to the COVID-19 pandemic; therefore, we have adjusted guidance with topline data now anticipated in the first half of 2021, which is, of course, dependent upon the rate of patient enrollment throughout the remainder of this year. Despite this shift in guidance, we are pleased with our progress in the X-TOLE study to date. We are particularly encouraged by our review of safety data on a blinded basis, which suggests that XEN1101 is currently being well tolerated. The rate of discontinuations to date in the study is lower than modeled. Of note, to date, more than 90% of subjects from the double-blind portion of the trial have entered the open-label extension phase. Based on this review of blinded safety data to date, we believe tolerability is well within the modeled parameters, and, therefore, we do not believe an interim analysis is required. Our goal is to complete the study, as planned, in the shortest possible time frame.

    Dr. Pimstone added, "We are also pleased to report that we recently completed a pharmacokinetic, or PK, study testing XEN496, our proprietary pediatric formulation of ezogabine, in healthy adult volunteers. The PK profile observed for XEN496 appears to be comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves, and we are excited that these data support Xenon's planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE. We recently received Fast Track designation for XEN496 from the FDA, and we look forward to receiving FDA feedback on our Phase 3 protocol, which we anticipate receiving in the second quarter. In addition, our partnered programs remain on track with no changes to our previous guidance."

    Proprietary Programs

    •  XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, a Phase 2b clinical trial (called the X-TOLE study) is underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. In order to alleviate pressures on physicians and healthcare workers and to continue to protect patient safety in the midst of the COVID-19 pandemic, Xenon's primary efforts are focused on patients currently enrolled in the study, either in the double-blind portion or in the open-label extension portion of the study, while making other necessary amendments in the study, including minimizing any in-person patient visits and making provisions for adequate drug supplies to patients wherever possible. Importantly, there is no anticipated impact to the data integrity of the study's efficacy endpoints since measurements are captured in a patient-reported, electronic seizure diary, which also provides the benefit of allowing sites and Xenon to monitor each patient in the trial in real-time remotely. Xenon is in close collaboration with each of its clinical sites in North America and Europe, taking specific direction from their respective clinical guidelines as they relate to new patient screening and randomization. The vast majority of clinical sites are not screening or randomizing any new patients, and Xenon is supportive of the prudent steps these clinical sites are taking that are focused on protecting patient safety as a first priority.
                  
      For the patients who have been enrolled and treated to date in the X-TOLE trial, Xenon can review blinded data to assess safety, tolerability and discontinuations. To date, XEN1101 has been well-tolerated and the rate of discontinuations from the study are below what had been modeled. In addition, to date, more than 90% of subjects from the double-blind portion of the trial have rolled-over into the open-label extension phase. Therefore, based on analysis of the blinded safety data to date, Xenon does not expect to conduct an interim analysis, which was an option that would have allowed for re-sizing of lower dose groups or for other changes to the study if tolerability was different than modeled. Xenon is exploring the expansion of the X-TOLE clinical trial to include new sites in both existing and new jurisdictions to support enhanced patient screening as soon as the clinical trial sites deem it safe to do so. Xenon is adjusting its guidance for topline data, which was previously expected in the second half of 2020 and is now anticipated in the first half of 2021, dependent upon feedback from the clinical sites and patient enrollment rates. Xenon also continues to explore the development of XEN1101 in other neurological indications.
    • XEN496 (active ingredient ezogabine) is a Kv7 potassium channel modulator being developed by Xenon. The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for the investigation of XEN496 for the treatment of seizures related to KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). The FDA has also indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. Xenon recently completed a pharmacokinetic (PK) study testing its proprietary pediatric formulation of ezogabine (XEN496) in 24 healthy adult volunteers. Subjects were given a single 400 mg dose of XEN496 in either fed or fasted states. While the study was not designed to determine bioequivalence given ezogabine is not available to use as a comparator, the PK profile observed for XEN496 appears to be comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves, which supports Xenon's planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE. The full PK data will be submitted to the FDA once the final study report is available. Feedback from the FDA regarding the Phase 3 clinical trial design is expected in the second quarter of 2020, and the Phase 3 clinical trial in KCNQ2-DEE is anticipated to start in 2020, dependent upon the ability to initiate clinical sites and patient enrollment given the ongoing COVID-19 pandemic.
       
    • XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study is examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy. Results from this Phase 2 study are expected in 2020, dependent upon patient enrollment rates given the ongoing COVID-19 pandemic. Depending on the final results from the study, CAE may represent a potential orphan indication for future development of XEN007.

    Partnered Programs

    • NBI-921352: Xenon has an ongoing collaboration with Neurocrine Biosciences, Inc. to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor for epilepsy. There is currently no change to previous guidance. Neurocrine Biosciences anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
       
    • FX301: Flexion Therapeutics, Inc. has acquired the global rights to develop and commercialize FX301 (formerly XEN402), a Nav1.7 inhibitor. Flexion's pre-clinical FX301 program consists of XEN402 formulated for extended release from a thermosensitive hydrogel. There is currently no change to previous guidance. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021.

    Financial and Operational Guidance

    As reported on March 9, 2020, cash and cash equivalents and marketable securities as of December 31, 2019 were $141.4 million, compared to $119.3 million as of December 31, 2018. Subsequent to December 31, 2019, Xenon raised additional net proceeds of approximately $102.8 million, net of underwriting discounts and commissions, but before offering expenses, under its November 2019 ATM equity offering and an underwritten public offering. Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2022, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    Xenon's estimated balance as of February 29, 2020 of approximately $235 million of cash, cash equivalents and marketable securities is a preliminary estimate based on management's analysis, is subject to further internal review, and has not been reviewed or audited by Xenon's external auditors.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; our estimated balance of cash, cash equivalents and marketable securities as of February 29, 2020; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2022; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. Our preliminary estimate of the balance of our cash, cash equivalents and marketable securities as of February 29, 2020 is the responsibility of management, is subject to management's review and the final balance could differ from management's preliminary estimate. This preliminary estimate has not been reviewed or audited by Xenon's independent registered public accounting firm and no assurance is given by such independent registered public accounting firm on such preliminary estimate. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  41. BURNABY, British Columbia, March 26, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced equity inducement grants to eight new non-officer employees consisting of an aggregate of 63,200 share options. All of the foregoing share options were approved by the Compensation Committee of the Company's Board of Directors with an effective date of March 25, 2020 and were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

    The share options have an exercise price of $11.25 per common share, which is equal to the closing price per share of Xenon's common shares on the grant date of March…

    BURNABY, British Columbia, March 26, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced equity inducement grants to eight new non-officer employees consisting of an aggregate of 63,200 share options. All of the foregoing share options were approved by the Compensation Committee of the Company's Board of Directors with an effective date of March 25, 2020 and were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

    The share options have an exercise price of $11.25 per common share, which is equal to the closing price per share of Xenon's common shares on the grant date of March 25, 2020. The shares underlying the options vest over four years, with 25% vesting on the one-year anniversary of the date of grant and 1/36th of the remaining shares vesting monthly thereafter on the last day of each month, subject to such option recipient's continued service relationship with the Company. Each option has a 10-year term and is subject to the terms and conditions of the share option agreement and the terms of the Company's 2019 Inducement Equity Incentive Plan.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  42. Xenon's Robust Neurology Pipeline of Proprietary and Partnered Programs Advances with Multiple Important Milestone Opportunities Anticipated in 2020

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, March 09, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today reported its financial results for the year ended December 31, 2019 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We are focused on developing multiple innovative products for the treatment of epilepsy and believe that Xenon has one of the most exciting epilepsy pipelines currently in development. Bolstered by a strong balance sheet, Xenon is entering a ‘data-rich…

    Xenon's Robust Neurology Pipeline of Proprietary and Partnered Programs Advances with Multiple Important Milestone Opportunities Anticipated in 2020

    Conference Call at 4:30 pm ET Today

    BURNABY, British Columbia, March 09, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today reported its financial results for the year ended December 31, 2019 and provided a corporate update.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We are focused on developing multiple innovative products for the treatment of epilepsy and believe that Xenon has one of the most exciting epilepsy pipelines currently in development. Bolstered by a strong balance sheet, Xenon is entering a ‘data-rich' period with the expectation that a number of our product candidates will either enter mid to late stage clinical trials or generate important clinical data in 2020."

    Dr. Pimstone continued, "Within our proprietary programs, we anticipate top-line data from our ongoing XEN1101 Phase 2b clinical trial in adult focal epilepsy later this year, and we continue to analyze other potential clinical indications for this novel Kv7 potassium channel modulator. We expect FDA feedback on our Phase 3 protocol for XEN496 early within the second quarter, and expect to initiate a Phase 3 pivotal trial with XEN496 in patients with KCNQ2-DEE, a severe and rare form of pediatric epilepsy, in 2020. In addition, results from the physician-led Phase 2 study in treatment-resistant childhood absence epilepsy, also expected in 2020, will help shape our development strategy for XEN007."

    Dr. Pimstone added, "Our partnered programs are also expected to make progress in the coming months, providing opportunities to earn milestone payments as they advance through development. Our collaborator, Neurocrine Biosciences, expects to file an IND in mid-2020 in order to start a Phase 2 clinical trial for NBI-921352 (formerly XEN901) in SCN8A-DEE pediatric patients, and Flexion continues its development planning for FX301 and anticipates initiating clinical trials in 2021."

    Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, a Phase 2b clinical trial (called the X-TOLE study) is underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient enrollment for this XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. Long term six-and nine-month toxicology studies have now been completed, providing support for the 12-month open label extension for patients enrolled in the Phase 2b clinical trial. Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020. Xenon continues to explore the development of XEN1101 in other neurological indications.
       
    • XEN496 (active ingredient ezogabine) is a Kv7 potassium channel modulator being developed by Xenon. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for XEN496 as a treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). The FDA previously indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. In December 2019, Xenon filed an Investigational New Drug (IND) application with the FDA related to a pharmacokinetic (PK) study testing our proprietary pediatric formulation of ezogabine (XEN496) in healthy adult volunteers.  In January 2020, Xenon received permission to proceed with the study, which is now ongoing and expected to be completed in the first quarter of 2020. In parallel, feedback from correspondence with the FDA regarding the Phase 3 clinical trial design is expected early in the second quarter of 2020. A Phase 3 clinical trial in KCNQ2-DEE is anticipated to start in 2020.
       
    • XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study is ongoing to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy. Results from this Phase 2 study are expected in 2020. Depending on the results from the study, CAE may represent a potential orphan indication for future development of XEN007.

    Partnered Programs

    • Xenon has an ongoing collaboration with Neurocrine Biosciences, Inc. to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor for epilepsy. In addition, Neurocrine Biosciences gained an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also included a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors. Neurocrine Biosciences anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
       
    • Flexion Therapeutics, Inc., has acquired the global rights to develop and commercialize FX301 (formerly XEN402), a Nav1.7 inhibitor. Flexion's pre-clinical FX301 program consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021.

    2019 Financial Results

    Cash and cash equivalents and marketable securities as of December 31, 2019 were $141.4 million, compared to $119.3 million as of December 31, 2018. There were 28,139,228 common shares and 1,016,000 Series 1 Preferred Shares, which are convertible into common shares on a one-for-one basis at the option of the holder, subject to certain limitations, outstanding as of December 31, 2019. 

    Included in cash and cash equivalents and marketable securities as of December 31, 2019, are net proceeds of $10.7 million from the sale of 805,643 common shares under Xenon's November 2019 at-the-market equity offering, or ATM, as well as an upfront fee of $50.0 million pursuant to the terms of Xenon's license and collaboration agreement with Neurocrine Biosciences which included a $30.0 million payment in cash and a $20.0 million equity investment in 1,408,847 common shares of Xenon. Subsequent to December 31, 2019, Xenon has raised additional net proceeds of approximately $102.8 million, net of underwriting discounts and commissions, but before offering expenses, from the sale of 6,759,187 common shares under its November 2019 ATM equity offering and an underwritten public offering.

    Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2022, excluding any revenue generated from existing partnerships or potential new partnering arrangements.

    For the year ended December 31, 2019, Xenon reported total revenue of $6.8 million, whereas no revenue was recognized for the same period in 2018.  In 2019, revenue of $3.5 million was recognized in connection with the agreement entered into in September 2019 with Flexion for the global rights to develop and commercialize XEN402.  In addition, revenue of $3.3 million was recognized for the transfer of licenses and related technology and know-how as well as for research and development services provided in 2019 under the license and collaboration agreement with Neurocrine Biosciences.

    Research and development expenses for the year ended December 31, 2019 were $38.8 million, compared to $23.6 million for the same period in 2018. The increase of $15.2 million was primarily attributable to increased spending on Xenon's clinical development product candidates. Future clinical developments costs associated with the development of product candidates under the Neurocrine Biosciences collaboration including XEN901, now known as NBI-921352, will be borne by Neurocrine Biosciences. 

    General and administrative expenses for the year ended December 31, 2019 were $10.8 million, compared to $8.4 million for the same period in 2018. The increase of $2.4 million was primarily attributable to increased salaries and benefits, legal expenses for intellectual property protection, business development expenses and recruitment fees.

    Other operating expenses were nil in the year ended December 31, 2019, compared to $6.0 million for the same period in 2018. The decrease is due to a one-time payment to Valeant Pharmaceuticals Luxembourg S.a.r.l. and Valeant Pharmaceuticals Ireland Limited, together, Bausch Health, for the buy-out of all future milestone payments and royalties owed to Bausch Health with respect to the XEN1101 program.

    Other income for the year ended December 31, 2019 was $1.2 million, compared to $3.5 million for the same period in 2018. The decrease of $2.3 million was primarily driven by a $4.4 million gain on the termination of the collaboration agreement with Teva Pharmaceuticals International GmbH and Teva Canada Limited in March 2018, partially offset by a change in foreign exchange gains and losses and interest income earned on Xenon's cash and investment balances.

    Net loss for the year ended December 31, 2019 was $41.6 million, compared to $34.5 million for the same period in 2018. The change was primarily attributable to higher research and development expenses as compared to the same period in 2018, partially offset by revenue recognized in the year pursuant to the agreements with Flexion and Neurocrine Biosciences and the one-time payment to Bausch Health with respect to the XEN1101 program which occurred in 2018.

    Conference Call Information

    Xenon will host a conference call and live audio webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its 2019 financial results and to provide a business update. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8487337. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2022; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    XENON PHARMACEUTICALS INC.
    Condensed Consolidated Balance Sheets
    (Expressed in thousands of U.S. dollars)

       December 31,     December 31,  
      2019     2018  
    Assets              
    Current assets:              
    Cash and cash equivalents and marketable securities $ 141,358     $ 119,306  
    Other current assets   3,508       2,026  
    Other assets   2,831       1,096  
    Total assets $ 147,697     $ 122,428  
                   
    Liabilities              
    Current liabilities:              
    Accounts payable and accrued expenses   8,818       4,119  
    Deferred revenue   29,743        
    Term loan   4,650        
    Other current liabilities   168        
    Other liabilities   12,341       15,014  
    Total liabilities $ 55,720     $ 19,133  
                   
    Shareholders' equity $ 91,977     $ 103,295  
    Total liabilities and shareholders' equity $ 147,697     $ 122,428  
                   

    XENON PHARMACEUTICALS INC.
    Condensed Consolidated Statements of Operations
    (Expressed in thousands of U.S. dollars except share and per share amounts)

       Year Ended December 31,  
      2019     2018  
    Revenue $ 6,829     $  
                   
    Operating expenses:              
    Research and development   38,845       23,634  
    General and administrative   10,803       8,406  
    Buy-out of future milestones and royalties         6,000  
    Total operating expenses   49,648       38,040  
    Loss from operations   (42,819 )     (38,040 )
    Other income   1,201       3,519  
    Loss before income taxes   (41,618 )     (34,521 )
    Income tax recovery   23       24  
    Net loss and comprehensive loss   (41,595 )     (34,497 )
    Net loss attributable to preferred shareholders   (1,568 )     (2,881 )
    Net loss attributable to common shareholders $ (40,027 )   $ (31,616 )
                   
    Net loss per common share:              
    Basic and diluted $ (1.54 )   $ (1.63 )
    Weighted-average common shares outstanding:              
    Basic and diluted   25,939,405       19,425,711  
                   

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  43. BURNABY, British Columbia, March 02, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that it will report its 2019 financial and operating results after the close of U.S. financial markets on Monday, March 9, 2020. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8487337. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following…

    BURNABY, British Columbia, March 02, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that it will report its 2019 financial and operating results after the close of U.S. financial markets on Monday, March 9, 2020. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8487337. The webcast will be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  44. BURNABY, British Columbia, Feb. 14, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that the underwriters of its previously announced public offering of 3,750,000 common shares, which initially closed on January 27, 2020, have exercised in full their option to purchase an additional 562,500 common shares at the public offering price of $16.00 per share, raising additional gross proceeds of $9.0 million and increasing the total gross proceeds of the public offering to $69.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon. 

    Jefferies, Stifel and Guggenheim Securities acted as joint book-running managers…

    BURNABY, British Columbia, Feb. 14, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that the underwriters of its previously announced public offering of 3,750,000 common shares, which initially closed on January 27, 2020, have exercised in full their option to purchase an additional 562,500 common shares at the public offering price of $16.00 per share, raising additional gross proceeds of $9.0 million and increasing the total gross proceeds of the public offering to $69.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon. 

    Jefferies, Stifel and Guggenheim Securities acted as joint book-running managers for the offering. Bloom Burton Securities Inc. acted as financial advisor to Xenon in connection with the transaction.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on August 6, 2019 and declared effective by the SEC on August 15, 2019. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821- 7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at 212-518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com

    No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Xenon Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com


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  45. BURNABY, British Columbia, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced public offering of 3,750,000 common shares pursuant to its existing shelf registration statement at a public offering price of $16.00 per share. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, were $60.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days from January 22, 2020 to purchase up to an additional 562,500 common shares at the public offering price, less the underwriting discounts…

    BURNABY, British Columbia, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced public offering of 3,750,000 common shares pursuant to its existing shelf registration statement at a public offering price of $16.00 per share. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, were $60.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days from January 22, 2020 to purchase up to an additional 562,500 common shares at the public offering price, less the underwriting discounts and commissions.

    Jefferies, Stifel and Guggenheim Securities acted as joint book-running managers for the offering. Bloom Burton Securities Inc. acted as financial advisor to Xenon in connection with the transaction.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on August 6, 2019 and declared effective by the SEC on August 15, 2019. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at 212-518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

    No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Xenon Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  46. BURNABY, British Columbia, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 3,750,000 common shares pursuant to its existing shelf registration statement at a public offering price of $16.00 per share. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, are expected to be approximately $60.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days to purchase up to an additional 562,500 common shares at the public offering price, less the underwriting discounts…

    BURNABY, British Columbia, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 3,750,000 common shares pursuant to its existing shelf registration statement at a public offering price of $16.00 per share. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, are expected to be approximately $60.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days to purchase up to an additional 562,500 common shares at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about January 27, 2020, subject to customary closing conditions.

    Jefferies, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on August 6, 2019 and declared effective by the SEC on August 15, 2019. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC's website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821- 7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

    No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated closing of the public offering. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, as well as the other risks identified in our filings with the SEC and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Xenon Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  47. BURNABY, British Columbia, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of its common shares pursuant to its existing shelf registration statement. It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional 15% of the common shares offered in the offering, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies, Stifel and Guggenheim Securities are acting…

    BURNABY, British Columbia, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of its common shares pursuant to its existing shelf registration statement. It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional 15% of the common shares offered in the offering, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    Jefferies, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering.

    A shelf registration statement relating to the common shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on August 6, 2019 and declared effective by the SEC on August 15, 2019. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821- 7388; from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, or by phone at (415) 364-2720 or by email at syndprospectus@stifel.com; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

    No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated public offering. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, as well as the other risks identified in our filings with the SEC and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    Xenon Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

     

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  48. Xenon's Proprietary Programs Continue to Advance with Multiple Mid to Late Stage Clinical Trials Anticipated to be Underway in 2020

    Xenon Eligible for Milestone Payments Based on the Advancement of Partnered Programs

    Experienced Biotech Executive, Dr. Clarissa Desjardins, Joins Xenon's Board of Directors

    BURNABY, British Columbia, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today provided a corporate update and outlined its key milestone opportunities for 2020.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "Xenon is entering 2020 in a very strong position with an exciting portfolio of proprietary neurology-focused candidates in clinical development, a…

    Xenon's Proprietary Programs Continue to Advance with Multiple Mid to Late Stage Clinical Trials Anticipated to be Underway in 2020

    Xenon Eligible for Milestone Payments Based on the Advancement of Partnered Programs

    Experienced Biotech Executive, Dr. Clarissa Desjardins, Joins Xenon's Board of Directors

    BURNABY, British Columbia, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, today provided a corporate update and outlined its key milestone opportunities for 2020.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "Xenon is entering 2020 in a very strong position with an exciting portfolio of proprietary neurology-focused candidates in clinical development, a healthy balance sheet, and valued collaborators advancing partnered programs. We expect to have multiple mid to late stage clinical trials underway in 2020 putting us in a position to generate important clinical data in 2020."

    Dr. Pimstone continued, "We anticipate a number of important milestone events in 2020, including the initiation of a Phase 3 clinical trial with XEN496 in patients with KCNQ2-DEE, a severe and rare form of pediatric epilepsy. In addition to the ongoing XEN1101 Phase 2b clinical trial in adult focal epilepsy, where we anticipate top-line data later this year, we are also seeking to expand the clinical development of XEN1101 in 2020 as we evaluate additional potential clinical indications for this novel Kv7 potassium channel modulator. Additionally, we look forward to the results from a physician-led Phase 2 study examining XEN007 in treatment-resistant childhood absence epilepsy."

    Dr. Pimstone added, "We are also fortunate to work with great collaborators who continue to advance our partnered programs. Neurocrine has guided that it expects to file an IND in mid-2020 in order to start a Phase 2 clinical trial for XEN901 (now known as NBI-921352) in SCN8A-DEE pediatric patients. Flexion continues to develop its pre-clinical FX301 program focused on peripheral nerve block for control of post-operative pain, and anticipates initiating FX301 clinical trials in 2021."

    Anticipated Milestones

    Proprietary Programs

    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. A Phase 2b double-blind, placebo-controlled, multicenter clinical trial (called the X-TOLE study) is underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient enrollment for this XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. Long term six-and nine-month toxicology studies have now been completed, providing support for the 12-month open label extension for patients enrolled in the Phase 2b clinical trial. Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020. Xenon continues to explore the development of XEN1101 in other neurological indications.
       
    • XEN496 (active ingredient ezogabine) is a Kv7 potassium channel modulator being developed by Xenon. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for XEN496 as a treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). A pharmacokinetic (PK) study testing Xenon's proprietary pediatric formulation of ezogabine (XEN496) in healthy adult volunteers is expected to complete in the first quarter of 2020. The FDA previously indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. After completion of the XEN496 PK study and discussions with the FDA on a Phase 3 clinical trial design in the first quarter of 2020, Xenon expects to initiate a Phase 3 clinical trial in KCNQ2-DEE.
       
    • XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study has recently been initiated to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy. Results from this Phase 2 investigator-led proof-of-concept study are expected in 2020. Depending on the results from the study, CAE may represent a potential orphan indication for future development of XEN007.

    Partnered Programs             

    • In December 2019, Xenon entered into a license and collaboration agreement with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) to develop first-in-class treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor for epilepsy. In addition, Neurocrine Biosciences gained an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also included a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors. Neurocrine Biosciences anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A developmental and epileptic encephalopathy patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
       
    • In September 2019, Xenon entered into an agreement with Flexion Therapeutics, Inc. (NASDAQ:FLXN) that provides Flexion with the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor. Flexion's pre-clinical program, known as FX301, consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021.

    Corporate Updates

    • Effective immediately, Dr. Clarissa Desjardins has been appointed to Xenon's Board of Directors and will also serve on the Compensation Committee. An award-winning entrepreneur with over 25 years of biotechnology experience, Dr. Desjardins has a doctorate in neurology and neurosurgery from McGill University's Faculty of Medicine. In 2011, Dr. Desjardins founded Clementia Pharmaceuticals, a publicly traded biotechnology company focused on rare bone disorders that was acquired by Ipsen S.A. in 2019 for up to $1.3 billion. Dr. Richard Scheller will resign from Xenon's Board effective January 14, 2020 after serving as an independent director since 2015.

    Dr. Pimstone stated, "I am pleased to welcome Clarissa Desjardins to our Board of Directors. With her extensive biotechnology, entrepreneurial, and neuroscience background, Clarissa is a superb addition to Xenon's Board. I expect her contributions will be invaluable as we continue to advance our clinical programs and strive to develop new therapeutics for patients in need. I also wish to thank Richard for his esteemed counsel and service on our Board of Directors. The Xenon team wishes him well in all of his future endeavors."

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements and supporting assumptions are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  49. Overview of Clinical Stage XEN901 and Related Patient Survey to be Presented in the "Genetic Epilepsies – Updates in the Science and Diagnosis" Exhibit in Room 318-319 on Sunday, December 8th

    Pre-Clinical Work Suggests Selective Sodium Channel Inhibitors that Reduce Action Potential Firing in Excitatory Neurons, While Sparing Inhibitory Interneurons, May Provide Promising Drug Profile

    BURNABY, British Columbia, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, announced today that it will provide updates on its partnered epilepsy programs at the American Epilepsy Society (AES) Annual Meeting held in Baltimore, MD.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said…

    Overview of Clinical Stage XEN901 and Related Patient Survey to be Presented in the "Genetic Epilepsies – Updates in the Science and Diagnosis" Exhibit in Room 318-319 on Sunday, December 8th

    Pre-Clinical Work Suggests Selective Sodium Channel Inhibitors that Reduce Action Potential Firing in Excitatory Neurons, While Sparing Inhibitory Interneurons, May Provide Promising Drug Profile

    BURNABY, British Columbia, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, announced today that it will provide updates on its partnered epilepsy programs at the American Epilepsy Society (AES) Annual Meeting held in Baltimore, MD.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "There are a number of presentations at the AES meeting related to our recently announced license and collaboration with Neurocrine Biosciences. Our presentations provide details on the clinical stage XEN901 epilepsy program and other pre-clinical licensed Nav1.6 and dual Nav1.2/1.6 programs. In addition to the scientific poster sessions at AES, we will be presenting information on both our partnered and proprietary programs at the BioMarin scientific exhibit on Sunday."

    On December 2, 2019, Xenon announced a license and collaboration agreement with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) to develop first-in-class treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy, including focal epilepsy. In addition, Neurocrine Biosciences gained an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also included a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors.

    The presentations related to XEN901 and earlier stage selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitor partnered programs at the AES meeting include:

    • XEN901: A poster presentation entitled, "A Phase 1 Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of XEN901, a Novel, Selective Nav1.6 Sodium Channel Inhibitor for the Treatment of SCN8A-Related Epilepsy" will be presented as Poster #15 in the BioMarin exhibit. A Phase 1 clinical trial was completed using a powder-in-capsule formulation of XEN901 in healthy adult subjects. Xenon developed a pediatric-specific, granule formulation of XEN901, and juvenile toxicology studies to support pediatric development activities have recently been completed. Neurocrine Biosciences anticipates filing an IND application with the FDA in the middle of 2020 in order to start a proposed clinical trial for XEN901 in SCN8A-DEE patients. Additionally, the results from an online survey of caregivers will be presented in Poster #18, entitled "An Online Survey of Caregivers of Patients with SCN8A Related Epilepsy." The survey results help to improve the knowledge of disease course and phenotypic heterogeneity, as well as inform clinical trial design for later stages of development.

    • Nav1.6 and Dual Nav1.2/1.6 Inhibitors: In a poster entitled, "XEN393, A Novel Selective Dual Inhibitor of Nav1.2/Nav1.6 Channels Prevents Electrically-Induced Seizures in Mice and Rats," data are presented that show dual Nav1.2/1.6 inhibitors may provide a novel, mechanistically differentiated profile distinct from all marketed non isoform selective sodium channel blockers. Because of the dynamic nature of sodium channel expression during development, a number of childhood genetic epilepsies that could benefit from a dual Nav1.2/1.6 inhibitor. In a poster entitled, "Nav1.6 Selective and Nav1.2/Nav1.6 Dual Inhibitors Reduce Action Potential Firing in Mouse Cortical Pyramidal Neurons While Sparing Inhibitory Interneuron Firing," pre-clinical data is presented to support the hypothesis that selective Nav1.6 and Nav1.2/1.6 inhibitors that reduce action potential firing in excitatory neurons, while sparing inhibitory interneurons, could provide a better pharmacologic profile for new anti-seizure medicines. A compilation of this pre-clinical work – showing that novel small molecule modulators of brain voltage gated sodium channels have the potential to drive new personalized therapies for patients with both gain- and loss-of-function mutations – will be presented in the BioMarin exhibit as Poster #14 entitled "Selective Sodium Channel Inhibitors and Potentiators; Pharmacology in Cortical Slices from Wild Type and Dravet Mice."

    About the BioMarin Scientific Exhibit: "Genetic Epilepsies – Updates in the Science and Diagnosis"
    Xenon, in collaboration with Invitae and Stoke Therapeutics, is participating in the BioMarin Scientific Exhibit entitled "Genetic Epilepsies – Updates in the Science and Diagnosis" on Sunday, December 8, 2019 from 8:00 am ET to 5:00 pm ET in the Convention Center, Room 318-319 on Level 300 at the AES 2019 Annual Meeting.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements and supporting assumptions are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN901 and our and our collaborators' other product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN901 and our and our collaborators' other product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN901 and our and our collaborators' other product candidates; our and our collaborators' ability to successfully develop and achieve milestones in development programs; the timing and results of interactions with regulators; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators and partners; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

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  50. Xenon's Epilepsy Programs Continue to Advance Including Ongoing XEN1101 Phase 2b Clinical Trial in Adult Focal Epilepsy and Plans for Anticipated Pediatric XEN496 Pivotal Phase 3 Clinical Trial in KCNQ2-DEE Patients

    Promising New Pre-Clinical Data Support Precision Medicine Approach to Treat Dravet Syndrome with Highly Selective Potentiators of Nav1.1

    Xenon Extends Invitation to View its Presentations in the "Genetic Epilepsies – Updates in the Science and Diagnosis" Exhibit in Room 318-319 on Sunday, December 8th

    BURNABY, British Columbia, Dec. 06, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, announced today that it will provide updates on its proprietary, neurology programs…

    Xenon's Epilepsy Programs Continue to Advance Including Ongoing XEN1101 Phase 2b Clinical Trial in Adult Focal Epilepsy and Plans for Anticipated Pediatric XEN496 Pivotal Phase 3 Clinical Trial in KCNQ2-DEE Patients

    Promising New Pre-Clinical Data Support Precision Medicine Approach to Treat Dravet Syndrome with Highly Selective Potentiators of Nav1.1

    Xenon Extends Invitation to View its Presentations in the "Genetic Epilepsies – Updates in the Science and Diagnosis" Exhibit in Room 318-319 on Sunday, December 8th

    BURNABY, British Columbia, Dec. 06, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical stage biopharmaceutical company, announced today that it will provide updates on its proprietary, neurology programs at the American Epilepsy Society (AES) Annual Meeting held in Baltimore, MD.

    Dr. Simon Pimstone, Xenon's Chief Executive Officer, said, "We continue to advance our portfolio of neurology-focused candidates, and have a number of presentations on XEN496 and XEN1101 at the AES meeting in Baltimore. A pediatric-specific formulation for XEN496 has been completed, and we will conduct a pharmacokinetic study in healthy adult volunteers to support an IND filing in the first quarter of 2020 for a pediatric pivotal Phase 3 clinical trial with XEN496 in patients with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE). Our XEN1101 Phase 2b clinical trial in adult focal epilepsy is ongoing with patient enrollment across sites in the U.S., Canada, and Europe, with top-line data expected in the second half of 2020. We believe XEN1101 has the potential to be an ‘only-in-class' therapy for focal seizures, and we are investigating other potential neurological indications for this promising program. In addition to our proprietary clinical stage programs, we look forward to supporting our partner Neurocrine Biosciences as they advance XEN901 and other sodium channel inhibitors."

    Dr. Pimstone continued, "We will also be presenting promising new pre-clinical data that support a precision medicine approach to treating Dravet Syndrome with highly selective potentiators of Nav1.1. We believe this mechanism could potentially address other neurologic indications where interneuron excitability is impaired."

    Dr. Pimstone added, "The AES Annual Meeting is an important event allowing us to showcase our epilepsy programs and connect with key opinion leaders and patient advocacy groups. This year, in addition to the presentation of Xenon's scientific posters, we are also participating in the BioMarin Scientific Exhibit entitled "Genetic Epilepsies – Updates in the Science and Diagnosis" which is a cross-industry collaboration with BioMarin, Invitae, and Stoke Therapeutics."

    Xenon is presenting updates on both of its proprietary, clinical-stage programs, XEN1101 and XEN496 – as well as presenting promising pre-clinical data – in a number of poster sessions at AES:

    • XEN496 (active ingredient ezogabine) is a Kv7 potassium channel modulator being developed by Xenon. A poster entitled "Development of a Pediatric Immediate-Release Formulation of the Potassium Channel Opener XEN496 (Ezogabine)" will be presented in a scientific poster session, as well as the BioMarin exhibit, on Sunday, December 8, 2019. After examining multiple formulations with different properties, Xenon has developed XEN496 as a pediatric-specific, granule formulation to be packaged as single-dose sprinkle capsules that has excellent properties supported by both in vitro and in vivo data. A planned pharmacokinetic (PK) study will test XEN496 in healthy adult volunteers, with data expected in the first quarter of 2020.

      Xenon will also present a poster in the BioMarin exhibit entitled, "An Online Survey of Caregivers of Patients with KCNQ2 Developmental & Epileptic Encephalopathy (KCNQ2-DEE)."  Xenon recently performed a caregiver survey to obtain additional phenotypic information regarding the seizure history of the disease as well as Anti-Seizure Medication (ASM) use, with a focus on ezogabine. Importantly, all seven respondents who had access to ezogabine responded that they saw improvements in their child's seizures, behavior or development while they were taking ezogabine. In addition, ezogabine was reported to be well-tolerated. Information from this survey, as well as input from key opinion leaders, will help inform the proposed Phase 3 clinical trial design and protocol.

      Xenon expects to file an Investigational New Drug (IND) application in the first quarter of 2020 to discuss with the FDA the design of a Phase 3 clinical trial in KCNQ2-DEE. The FDA has indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication.
    • XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. A poster entitled "Use of Transcranial Magnetic Stimulation (TMS) Data in the Design of a Dose Range Finding Efficacy, Safety, Tolerability, and Pharmacokinetics Study of XEN1101 in Patients with Focal Epilepsy" will be presented on Monday, December 9, 2019. This poster outlines the XEN1101 Phase 2 study design and concludes that incorporating TMS evidence of CNS activity in healthy volunteers may be a useful adjunct in refining dose selection for Phase 2 epilepsy studies. A Phase 2b double-blind, placebo-controlled, multicenter clinical trial (called the X-TOLE study), which is currently underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient enrollment for this XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. Long term six and nine-month toxicology studies have now been completed, providing support to the planned 12-month open label extension for patients enrolled in the Phase 2b clinical trial. Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020.

    • Xenon also continues to conduct pre-clinical work on other promising molecules to address neurological disorders. A poster entitled, "Small Molecule Potentiators of Nav1.1 Increase Action Potential Firing in Fast Spiking Cortical Inhibitory Interneurons from a Mouse Model of Dravet Syndrome" – which will be presented on Monday, December 9, 2019 – outlines promising work on highly selective small molecule potentiators of Nav1.1 that could address the underlying cause of Dravet Syndrome using a precision medicine approach. Selectively potentiating Nav1.1, the dominant sodium channel isoform expressed in inhibitory interneurons, restores the capability of Scn1a+/- interneurons to fire action potentials at high frequency. In brain slices from Scn1a+/- mice, the tested compound increased the firing rate of inhibitory neurons. A small molecule pharmaceutical with this profile could enable reversal of the fundamental defect in Dravet Syndrome and may have utility in other neurologic indications where interneuron excitability is impaired. Xenon intends to build upon this promising work and continue to advance potential Nav1.1 potentiators in pre-clinical development.

    About the BioMarin Scientific Exhibit: "Genetic Epilepsies – Updates in the Science and Diagnosis"
    Xenon, in collaboration with Invitae and Stoke Therapeutics, is participating in the BioMarin Scientific Exhibit entitled "Genetic Epilepsies – Updates in the Science and Diagnosis" on Sunday, December 8, 2019 from 8:00 am ET to 5:00 pm ET in the Convention Center, Room 318-319 on Level 300 at the AES 2019 Annual Meeting.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements and supporting assumptions are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN901, XEN1101 and our other product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN901, XEN1101 and our other product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101 and our other product candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN901, XEN1101 and other development programs, either alone or with our collaborators; the timing and results of our interactions with regulators; the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials; anticipated enrollment in our clinical trials; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators and partners; and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials, may impose additional requirements or delay the initiation of clinical trials; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

    Primary Logo

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  51. BURNABY, British Columbia, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will present at the 31st Annual Piper Jaffray Healthcare Conference in New York, NY on Wednesday, December 4, 2019 at 3:00 pm Eastern Time.

    A live audio webcast will be available on the investors section of Xenon's website at www.xenon-pharma.com and will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system…

    BURNABY, British Columbia, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will present at the 31st Annual Piper Jaffray Healthcare Conference in New York, NY on Wednesday, December 4, 2019 at 3:00 pm Eastern Time.

    A live audio webcast will be available on the investors section of Xenon's website at www.xenon-pharma.com and will be posted for replay following the event.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

    Primary Logo

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  52. BURNABY, British Columbia, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, announced that it will host a conference call and live audio webcast at 8:30 am Eastern Time (5:30 am Pacific Time) today to provide a corporate update on the license and collaboration agreement that was announced this morning to develop first-in-class treatments for epilepsy with Neurocrine Biosciences, Inc.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 3665957. The audio webcast will also be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and available for replay following…

    BURNABY, British Columbia, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, announced that it will host a conference call and live audio webcast at 8:30 am Eastern Time (5:30 am Pacific Time) today to provide a corporate update on the license and collaboration agreement that was announced this morning to develop first-in-class treatments for epilepsy with Neurocrine Biosciences, Inc.

    To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 3665957. The audio webcast will also be broadcast live on the "Investors" section of Xenon's website at www.xenon-pharma.com and available for replay following the call for 30 days.

    About Xenon Pharmaceuticals Inc.

    We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Investor/Media Contact:
    Jodi Regts
    Xenon Pharmaceuticals Inc.
    Phone: 604.484.3353
    Email: investors@xenon-pharma.com

    Primary Logo

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  53. Neurocrine Biosciences Gains Rights to XEN901, a Clinical Stage Selective Nav1.6 Sodium Channel Inhibitor, Being Developed for the Treatment of Epilepsy

    Xenon Receives $50 Million Upfront and Up to $1.7 Billion in Potential Development, Regulatory and Commercial Milestone Payments Across All Licensed Products, as well as Option to Co-Fund XEN901

    SAN DIEGO and BURNABY, British Columbia, Dec. 02, 2019 (GLOBE NEWSWIRE) --  Neurocrine Biosciences, Inc. (NASDAQ:NBIX) and Xenon Pharmaceuticals Inc. (NASDAQ:XENE) announced a license and collaboration agreement to develop first-in-class treatments for epilepsy.

    Neurocrine Biosciences gains an exclusive license to XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in…

    Neurocrine Biosciences Gains Rights to XEN901, a Clinical Stage Selective Nav1.6 Sodium Channel Inhibitor, Being Developed for the Treatment of Epilepsy

    Xenon Receives $50 Million Upfront and Up to $1.7 Billion in Potential Development, Regulatory and Commercial Milestone Payments Across All Licensed Products, as well as Option to Co-Fund XEN901

    SAN DIEGO and BURNABY, British Columbia, Dec. 02, 2019 (GLOBE NEWSWIRE) --  Neurocrine Biosciences, Inc. (NASDAQ:NBIX) and Xenon Pharmaceuticals Inc. (NASDAQ:XENE) announced a license and collaboration agreement to develop first-in-class treatments for epilepsy.

    Neurocrine Biosciences gains an exclusive license to XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy, including focal epilepsy. In addition, Neurocrine Biosciences gains an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also includes a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors.

    "We are excited to enter into this agreement with Xenon and leverage their expertise in precision medicine drug discovery to benefit the lives of people with epilepsy and serious neurological disorders," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "The agreement with Xenon strengthens Neurocrine Biosciences' diverse and growing pipeline and reinforces our long-term commitment of becoming a leading neuroscience-focused biopharmaceutical company."

    "With its proven expertise in developing and commercializing treatments for neurological disorders, we believe Neurocrine Biosciences is an ideal partner to maximize the potential value of XEN901 for patients," said Dr. Simon Pimstone, Chief Executive Officer of Xenon. "Importantly, this collaboration represents a significant investment in XEN901 and Xenon's earlier-stage Nav1.6 and Nav1.2/1.6 inhibitor programs and allows for a broader development of these promising compounds than we could accomplish independently. Furthermore, the additional capital from this transaction will support our efforts to advance and expand our proprietary pipeline."

    License and Collaboration Details / Financial Terms

    Under the terms of the agreement, Neurocrine Biosciences will be responsible for development costs associated with the programs and the agreement will be subject to the following terms:

    • Upfront License Payment: Xenon will receive $50 million, including a $30 million upfront payment in cash and a $20 million equity investment by Neurocrine Biosciences at a Xenon per share price of $14.196.
    • XEN901 Investigational New Drug (IND) Milestone: Xenon will receive up to $25 million upon the U.S. Food and Drug Administration (FDA) acceptance of an IND for XEN901, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
    • Collaboration Milestones: Xenon may also be entitled to receive up to approximately $1.7 billion in additional development, regulatory and commercial milestone payments related to XEN901 and other licensed Nav1.6 or Nav1.2/1.6 inhibitor products.
    • XEN901 Royalties: Xenon will have the right to receive a tiered royalty ranging from the low double-digits to mid-teen percentage in the U.S. and a tiered royalty at slightly lower rates outside the U.S. based upon aggregate global net sales. 
    • Other Product Royalties: Xenon will have the right to receive a tiered royalty for other Nav1.6 and Nav1.2/1.6 inhibitor products ranging from the mid-single to low double-digits in the U.S. and a tiered royalty at slightly lower rates outside the U.S. based upon aggregate global net sales.
    • Xenon Co-Fund Option: Xenon retains an option to co-fund 50% of the U.S. development costs of XEN901 or another product candidate in exchange for increased U.S. royalties, reaching 20% of U.S. net sales at the highest royalty tier for XEN901. 
    • Funded Collaboration: Neurocrine Biosciences will fund all clinical developments costs associated with the development of product candidates under the collaboration (subject to Xenon's Co-Fund Option) and will also fund a research collaboration up to 3 years with a minimum of 10 FTEs (full time equivalents) at Xenon. Xenon will be responsible for certain pre-clinical and a portion of certain near term manufacturing costs under the collaboration.

    Neurocrine Biosciences anticipates filing an IND application with the FDA in the middle of 2020 in order to start a proposed clinical trial for XEN901 in SCN8A-DEE patients.

    Conference Call Information

    Neurocrine Biosciences will provide further commentary on the collaboration during its presentation at the Evercore ISI 2nd Annual HealthCONx Conference at 8:45 a.m. EST on Tuesday, December 3, 2019.

    Today, Xenon will host a conference call at 8:30 a.m. EST to provide commentary on the collaboration. To access the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 3665957.

    Live audio webcasts of these presentations will be available under "Investors" on the companies' respective websites at: www.neurocrine.com and www.xenon-pharma.com. A replay of the webcast will be available for each presentation approximately one hour after the conclusion of each event and will be archived for approximately one month.

    About XEN901 Program for Epilepsy

    XEN901 is a potent, highly selective Nav1.6 sodium channel inhibitor being developed to treat pediatric patients with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other potential indications, including adult focal epilepsy. A Phase 1 clinical trial was completed using a powder-in-capsule formulation of XEN901 in healthy adult subjects.  Xenon has developed a pediatric-specific, granule formulation of XEN901, and juvenile toxicology studies to support pediatric development activities have recently been completed.

    About Neurocrine Biosciences

    Neurocrine Biosciences (NASDAQ:NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia and endometriosis* and clinical development programs in multiple therapeutic areas including Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome*. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    About Xenon Pharmaceuticals Inc.
    Xenon Pharmaceuticals (NASDAQ:XENE) is a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.

    Neurocrine Biosciences Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from transactions with Xenon Pharmaceuticals Inc. and the timing of completion of our clinical, regulatory, and other development activities. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: the Company's future financial and operating performance; risks or uncertainties related to the development of the Company's product candidates; risks that the FDA or other regulatory authorities may make adverse decisions regarding our product candidates; risks that clinical development activities may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for a product candidate; risks that the benefits of the agreements with Xenon Pharmaceuticals Inc. may never be realized; risks that our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2019. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

    Xenon Pharmaceuticals Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements and supporting assumptions are not based on historical fact, and include statements regarding the timing of and results from clinical trials and other development activities, including those related to XEN901 and the other pre-clinical compounds covered by our collaboration with Neurocrine Biosciences; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN901 and the other pre-clinical compounds covered by our collaboration with Neurocrine Biosciences; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN901 and the other pre-clinical compounds covered by our collaboration with Neurocrine Biosciences; our ability to achieve milestones in our collaboration with Neurocrine Biosciences and our other development programs; the progress and potential of our other ongoing development programs; and the potential receipt of milestone payments and royalties from our collaborators and partners. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

    Contact: Xenon Pharmaceuticals Inc.
    Jodi Regts (Media & Investors)
    604-484-3353
    investors@xenon-pharma.com

    Contact: Neurocrine Biosciences, Inc.
    Navjot Rai (Media)
    858-617-7623
    media@neurocrine.com

    Todd Tushla (Investors)
    858-617-7143
    ir@neurocrine.com

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  54. SAN DIEGO and BURNABY, British Columbia, Dec. 2, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) and Xenon Pharmaceuticals Inc. (NASDAQ:XENE) announced a license and collaboration agreement to develop first-in-class treatments for epilepsy.

    Neurocrine Biosciences gains an exclusive license to XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy, including focal epilepsy. In addition, Neurocrine Biosciences gains an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also includes a multi-year research collaboration…

    SAN DIEGO and BURNABY, British Columbia, Dec. 2, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) and Xenon Pharmaceuticals Inc. (NASDAQ:XENE) announced a license and collaboration agreement to develop first-in-class treatments for epilepsy.

    Neurocrine Biosciences gains an exclusive license to XEN901, a clinical stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy, including focal epilepsy. In addition, Neurocrine Biosciences gains an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also includes a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors.

    "We are excited to enter into this agreement with Xenon and leverage their expertise in precision medicine drug discovery to benefit the lives of people with epilepsy and serious neurological disorders," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "The agreement with Xenon strengthens Neurocrine Biosciences' diverse and growing pipeline and reinforces our long-term commitment of becoming a leading neuroscience-focused biopharmaceutical company."

    "With its proven expertise in developing and commercializing treatments for neurological disorders, we believe Neurocrine Biosciences is an ideal partner to maximize the potential value of XEN901 for patients," said Dr. Simon Pimstone, Chief Executive Officer of Xenon. "Importantly, this collaboration represents a significant investment in XEN901 and Xenon's earlier-stage Nav1.6 and Nav1.2/1.6 inhibitor programs and allows for a broader development of these promising compounds than we could accomplish independently. Furthermore, the additional capital from this transaction will support our efforts to advance and expand our proprietary pipeline."

    License and Collaboration Details / Financial Terms

    Under the terms of the agreement, Neurocrine Biosciences will be responsible for development costs associated with the programs and the agreement will be subject to the following terms:

    • Upfront License Payment: Xenon will receive $50 million, including a $30 million upfront payment in cash and a $20 million equity investment by Neurocrine Biosciences at a Xenon per share price of $14.196.
    • XEN901 Investigational New Drug (IND) Milestone: Xenon will receive up to $25 million upon the U.S. Food and Drug Administration (FDA) acceptance of an IND for XEN901, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.
    • Collaboration Milestones: Xenon may also be entitled to receive up to approximately $1.7 billion in additional development, regulatory and commercial milestone payments related to XEN901 and other licensed Nav1.6 or Nav1.2/1.6 inhibitor products.
    • XEN901 Royalties: Xenon will have the right to receive a tiered royalty ranging from the low double-digits to mid-teen percentage in the U.S. and a tiered royalty at slightly lower rates outside the U.S. based upon aggregate global net sales. 
    • Other Product Royalties: Xenon will have the right to receive a tiered royalty for other Nav1.6 and Nav1.2/1.6 inhibitor products ranging from the mid-single to low double-digits in the U.S. and a tiered royalty at slightly lower rates outside the U.S. based upon aggregate global net sales.
    • Xenon Co-Fund Option: Xenon retains an option to co-fund 50% of the U.S. development costs of XEN901 or another product candidate in exchange for increased U.S. royalties, reaching 20% of U.S. net sales at the highest royalty tier for XEN901. 
    • Funded Collaboration: Neurocrine Biosciences will fund all clinical developments costs associated with the development of product candidates under the collaboration (subject to Xenon's Co-Fund Option) and will also fund a research collaboration up to 3 years with a minimum of 10 FTEs (full time equivalents) at Xenon. Xenon will be responsible for certain pre-clinical and a portion of certain near term manufacturing costs under the collaboration.

    Neurocrine Biosciences anticipates filing an IND application with the FDA in the middle of 2020 in order to start a proposed clinical trial for XEN901 in SCN8A-DEE patients.

    Conference Call Information

    Neurocrine Biosciences will provide further commentary on the collaboration during its presentation at the Evercore ISI 2nd Annual HealthCONx Conference at 8:45 a.m. EST on Tuesday, December 3, 2019.

    Today, Xenon will host a conference call at 8:30 a.m. EST to provide commentary on the collaboration. To access the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 3665957.

    Live audio webcasts of these presentations will be available under "Investors" on the companies' respective websites at: www.neurocrine.com and www.xenon-pharma.com. A replay of the webcast will be available for each presentation approximately one hour after the conclusion of each event and will be archived for approximately one month.

    About XEN901 Program for Epilepsy

    XEN901 is a potent, highly selective Nav1.6 sodium channel inhibitor being developed to treat pediatric patients with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other potential indications, including adult focal epilepsy. A Phase 1 clinical trial was completed using a powder-in-capsule formulation of XEN901 in healthy adult subjects. Xenon has developed a pediatric-specific, granule formulation of XEN901, and juvenile toxicology studies to support pediatric development activities have recently been completed.

    About Neurocrine Biosciences

    Neurocrine Biosciences (NASDAQ:NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia and endometriosis* and clinical development programs in multiple therapeutic areas including Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome*. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on