Xenon Pharmaceuticals Reports 2017 Financial Results and Provides Corporate UpdateThursday, March 8, 2018
Two novel anti-epileptic drugs advancing in clinical development;
Interim XEN1101 Phase 1 data expected to be released in May 2018 at scientific symposium;
Xenon announces new clinical stage ion channel product to expand its neurology pipeline
Burnaby, BC, March 8, 2018--(T-Net)--Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today reported its financial results for the year ended December 31, 2017 and provided a corporate update.
Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, said, "In 2017, we concentrated our efforts on developing novel ion channel modulators to address central nervous system (CNS) disorders, and our product candidates are advancing as planned. We believe that XEN1101 and XEN901, our two proprietary epilepsy products that are currently in clinical development, have unique mechanisms of action and other attractive properties that could differentiate them from existing anti-epileptic drugs presently available to prescribing physicians."
Dr. Pimstone continued, "Xenon is poised to reach key milestone events within the next 6 to 12 months. We look forward to presenting interim Phase 1 data from our ongoing XEN1101 Phase 1 clinical trial, including results from a pilot transcranial magnetic stimulation (TMS) pharmacodynamic study, at the 14th EILAT Conference on New Antiepileptic Drugs and Devices to be held in Madrid, Spain in May 2018. We believe these interim results - which build upon the existing pre-clinical data and relevant benchmarks from ezogabine, an earlier generation Kv7 opener - could validate the activity of XEN1101 on CNS cortical hyperexcitability and support planning for the next stages of clinical development."
Dr. Pimstone added, "Additionally, we are excited to announce a new ion channel product candidate, XEN007, a CNS acting calcium channel modulator (active ingredient flunarizine). We have received FDA orphan drug designation for XEN007 for the treatment of hemiplegic migraine, a rare and severe form of migraine with a strong heritable component. To potentially expedite the development of XEN007, we have entered into key agreements that provide us with access to regulatory data and manufacturing support, which may allow us to advance this product candidate - either on our own or in partnership - directly into a Phase 2 clinical trial."
Achievements and Anticipated Milestones
2017 Financial Results
Cash and cash equivalents and marketable securities as of December 31, 2017 were $43.7 million, compared to $64.1 millionas of December 31, 2016. There were 17,998,420 common shares outstanding as of December 31, 2017. Based on current assumptions, which include fully supporting the planned clinical development of XEN1101 and XEN901, Xenon anticipates having sufficient cash to fund operations into mid-2019, excluding any revenue generated from existing partnerships or potential new partnering arrangements.
For the year ended December 31, 2017, Xenon reported total revenue of $0.3 million, compared to $1.8 million for the same period in 2016. The decrease of $1.5 million was primarily attributable to revenue recognized related to the upfront payment from the March 2014 genetics collaborative agreement with Genentech, which was fully recognized by March 2016, partially offset by a $0.25 million milestone payment recognized in July 2017 under the same collaborative agreement. The remaining decrease was due to less full-time equivalent funding from collaborative partners as resources were shifted from supporting collaborations to Xenon's proprietary programs.
Research and development expenses for the year ended December 31, 2017 were $25.6 million, compared to $19.8 million for the same period in 2016. The increase of $5.7 million was primarily attributable to spending on XEN1101 which was acquired in April 2017 and increased spending on pre-clinical, discovery and other internal programs as well as on XEN901, partially offset by a decrease in XEN801 expenses, a product candidate that is no longer being developed, and a decrease in collaboration expenses.
General and administrative expenses for the year ended December 31, 2017 were $7.3 million, compared to $6.8 million for the same period in 2016. The increase of $0.5 million was primarily attributable to increased costs for business development activities and salaries and benefits.
Other income for the year ended December 31, 2017 was $1.9 million and did not change significantly as compared to $1.8 million for the same period in 2016.
Net loss for the year ended December 31, 2017 was $30.7 million, compared to $23.0 million for the same period in 2016. The change was primarily attributable to lower revenue and higher research and development expenses and general and administrative expenses.
About Xenon Pharmaceuticals Inc.
We are a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing - both independently and with our collaborators - a novel product pipeline of central nervous system, or CNS, therapies to address areas of high unmet medical need, such as epilepsy and pain. For more information, please visit www.xenon-pharma.com.
XENON PHARMACEUTICALS INC.
Condensed Consolidated Balance Sheets
(Expressed in thousands of U.S. dollars)
|December 31,||December 31,|
|Cash and cash equivalents and marketable securities||$||43,667||$||64,146|
|Other current assets||1,154||1,529|
|Accounts payable and accrued expenses||3,383||3,586|
|Loan payable, current portion||700||—|
|Loan payable, long-term||6,104||—|
|Total liabilities and shareholders' equity||$||46,121||$||67,487|
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,|
|Research and development||25,573||19,828||15,152|
|General and administrative||7,313||6,792||9,786|
|Total operating expenses||32,886||26,620||24,938|
|Loss from operations||(32,575||)||(24,817||)||(9,361||)|
|Net loss per common share:|
|Weighted-average common shares outstanding:|
VP, Corporate Affairs & Investor Relations
Xenon Pharmaceuticals Inc.
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 expectations regarding the sufficiency of our cash to fund operations into mid-2019, the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN901, XEN1101 and our other product candidates, the plans of our collaboration partners, the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN901, XEN1101 and our other product candidates, the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN901, XEN1101 and our other product candidates, the efficacy of our clinical trial designs, our ability to successfully develop and achieve milestones in the XEN901, XEN1101 and other development programs, the potential to advance XEN007 directly into a Phase 2 clinical trial, the anticipated benefits of the unique mechanisms of action of XEN901 and XEN1101, the design of our clinical trials and anticipated enrollment, the progress and potential of our other ongoing development programs, the anticipated termination of our collaboration agreement with Teva, and anticipated receipt of the OSC exemptive relief order and the effectiveness of the transfer and assignment of 1,000,000 common shares to us by Teva. 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 efforts to expand our current pipeline may not be successful; 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 XEN007 to advance directly into a Phase 2 clinical trial; 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.
Burnaby, BC (Biotech/Life Sciences)
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