Xenon Pharmaceuticals Outlines Key Milestone Opportunities and Planned Leadership Transition in 2021Tuesday, January 19, 2021
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, BC, January 19, 2021--(T-Net)--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
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.
Burnaby, BC (Biotech/Life Sciences)
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