Xenon Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Corporate Update
Dr. Pimstone added, “With a healthy balance sheet, we are positioned to fully support these key clinical programs and look forward to a number of important events in the coming months. We anticipate that XEN1101, a Kv7 potassium channel opener, will be in a Phase 1 clinical trial in the fourth quarter of 2017. In addition, we look forward to filing an IND, or IND equivalent, application for XEN901, a selective Nav1.6 inhibitor, in the fourth quarter of this year. We also anticipate Genentech will advance GDC-0310 into a Phase 2 clinical trial in the first quarter of 2018.”
Second Quarter 2017 Highlights and Anticipated Milestones
- XEN1101 is a next-generation Kv7 potassium channel opener for the treatment of epilepsy. Pre-clinically, XEN1101 has demonstrated improved pharmacokinetics, selectivity, potency and efficacy over first-generation potassium channel modulators, such as ezogabine. Xenon anticipates filing an investigational new drug (IND), or IND equivalent, application to initiate a Phase 1 first-in-man clinical trial in the fourth quarter of 2017, and Phase 2 development is anticipated to begin by mid-2018.
- XEN901 is a potent, selective Nav1.6 sodium channel inhibitor for the treatment of rare infantile epileptic encephalopathies and other forms of epilepsy. XEN901 has demonstrated efficacy against seizures in an animal model of Nav1.6 gain-of-function SCN8A epilepsy as well as animal models that support the treatment of adult partial onset epilepsy. Xenon expects to file an IND, or IND equivalent, application in the fourth quarter of 2017.
- TV-45070 is a topical, small-molecule inhibitor of the sodium channel Nav1.7, and other sodium channels, expressed in the pain-sensing peripheral nervous system. In
June 2017, Xenon, along with its collaborator, Teva Pharmaceutical Industries Ltd., announced topline results from a Phase 2b clinical trial that evaluated the efficacy and safety of TV-45070 in patients with post-herpetic neuralgia. TV-45070 did not meet the primary endpoint of a statistically significant change in pain from baseline to week four as assessed by the numeric rating scale (NRS), and secondary endpoints were also not met. There were no safety concerns in the study. The companies plan to further analyze the data from this study to determine the next steps for TV-45070.
- Xenon's collaborator Genentech, a member of the
Roche Group, has completed a Phase 1 clinical trial for GDC-0310, which is an oral, selective Nav1.7 small-molecule inhibitor. Pending completion and assessment of ongoing preclinical studies, Genentech anticipates initiating a Phase 2 clinical trial for the potential treatment of pain in the first quarter of 2018.
July 2017, Xenon achieved a milestone in its pain genetics discovery collaboration with Genentech triggering a milestone payment. Xenon and Genentech have successfully discovered and identified a novel pain target by leveraging Xenon's Extreme Genetics platform based on the study of rare phenotypes of individuals who have either an inability to perceive pain or have non-precipitated spontaneous severe pain.
Second Quarter 2017 Financial Results
Cash and cash equivalents and marketable securities as of
For the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Other income for the quarter ended
Net loss for the quarter ended
Conference Call Information
Xenon will host a conference call and live audio webcast today at
Xenon is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and 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 are not based on historical fact, and include statements regarding our ability to achieve milestones in both our proprietary and partnered development programs, our expectations regarding the sufficiency of our cash to fund operations into the first quarter of 2019, the anticipated timing of IND or IND equivalent submissions with regulatory agencies, the initiation of future clinical trials, the timing of and results from our and our collaborators’ ongoing clinical trials and pre-clinical development activities, the plans of our collaboration partners and their interactions with regulatory agencies, the potential efficacy, future development plans and commercial potential of our and our collaborators’ product candidates and the progress and potential of 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: 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 discovery platform or ongoing collaborations 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 pursuant to our collaboration agreements; 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
“Xenon,” “Extreme Genetics” and the Xenon logo are registered trademarks or trademarks of
Condensed Consolidated Balance Sheets
(Expressed in thousands of U.S. dollars)
|June 30,||December 31,|
|Cash and cash equivalents and marketable securities||$||51,696||$||64,146|
|Other current assets||937||1,529|
|Accounts payable and accrued expenses||3,774||3,586|
|Total liabilities and shareholders’ equity||$||54,226||$||67,487|
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,|
|Research and development||6,109||5,103||12,012||9,467|
|General and administrative||1,799||1,676||3,899||3,571|
|Total operating expenses||7,908||6,779||15,911||13,038|
|Loss from operations||(7,893||)||(6,366||)||(15,880||)||(12,024||)|
|Net loss per common share:|
|Weighted-average common shares outstanding:|
Jodi RegtsVP, Corporate Affairs & Investor Relations Xenon Pharmaceuticals Inc.Phone: 604.484.3353 Email: email@example.com