Xenon Pharmaceuticals Reports Third Quarter 2015 Financial Results and Provides Corporate Update
Progress Includes Initiation of XEN801 Phase 1 Clinical Trial and Achievement of Milestones in Genentech Nav1.7 Clinical Program and Pain Genetics Collaboration
Conference Call/Webcast Today at
2015 Achievements to Date
Partnered Pain Programs with Teva and Genentech
Teva Pharmaceutical Industries Ltd.is conducting a randomized, double-blind, placebo-controlled Phase 2b clinical trial for TV-45070 in patients with post-herpetic neuralgia, with results expected in the second half of 2016.
Genentech Inc., a member of the Roche Group, is currently conducting a Phase 1 clinical trial for GDC-0276, which is expected to complete patient enrollment by the end of 2015. GDC-0276 is a selective, oral Nav1.7 small-molecule inhibitor being developed for the treatment of pain.
- Genentech recently advanced a second selective, oral Nav1.7 small-molecule inhibitor, GDC-0310, into a Phase 1 clinical trial.
- Xenon and Genentech also have an active research collaboration focused on other selective, oral small molecule inhibitors of Nav1.7.
Xenon and Genentech's second collaboration is focused on the discovery of novel pain targets in rare human pain disorders where individuals have either an inability to perceive pain or where individuals have non-precipitated spontaneous severe pain. Xenon met a key goal of this collaboration by identifying a new pain target, triggering a milestone payment in
Xenon's Proprietary Programs
XEN801, is a stearoyl Co-A desaturase, or SCD1 inhibitor, for the treatment of acne. Xenon initiated a Phase 1 clinical trial for XEN801 in
September 2015. If supported by positive data from the Phase 1 trial, Xenon plans to initiate a Phase 2 clinical trial by the end of 2015 or early 2016 in patients with moderate to severe acne. SCD1 is an enzyme involved in lipid synthesis that is expressed in sebaceous glands in the skin. By inhibiting SCD1, XEN801 represents a novel approach to treat acne with a dual mechanism of action expected to reduce both sebum production and the size and number of sebaceous glands.
- Xenon's development of a Nav1.6 sodium channel inhibitor for the treatment of Dravet Syndrome, an orphan disease of severe childhood epilepsy, continues to progress and Xenon expects to file an investigational new drug application in the second half of 2016. Xenon's approach to treating Dravet Syndrome is to develop selective and potent inhibitors of Nav1.6 which have demonstrated efficacy for seizures in a pre-clinical animal model.
- Xenon also anticipates announcing its next drug discovery program in 2015 by leveraging its Extreme Genetics discovery platform and expertise in ion channel chemistry and biology.
Xenon's Glybera licensee,
uniQure Biopharma B.V.(Nasdaq:QURE), has reported that its commercialization partner, Chiesi Farmaceutici S.p.A., has submitted price and reimbursement dossiers in key European countries in order to make Glybera accessible to patients. Chiesi has sole control over commercialization in Europeand neither uniQure nor Xenon will be providing additional guidance regarding commercialization progress. Glybera is the first gene therapy product approved in the European Unionfor the treatment of the orphan disorder lipoprotein lipase deficiency, and is the first product whose active ingredient was derived from Xenon's platform to receive commercial approval. Xenon is eligible to receive a royalty on commercial sales.
Third Quarter 2015 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 both the quarter ended
Other expense for the quarter ended
Net loss for the quarter ended
Conference Call Today at
Xenon will host a conference call and live audio webcast today at
To participate in the call, please dial (855) 779-9075 for domestic callers or (631) 485-4866 for international callers, and provide conference ID number 74074102. 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.
Xenon is a clinical-stage biopharmaceutical company discovering and developing a pipeline of differentiated therapeutics for orphan indications that it intends to commercialize on its own and for larger market indications that the company intends to partner with global pharmaceutical companies. Xenon has built a core enabling discovery platform, referred to as Extreme Genetics®, for the discovery of validated drug targets by studying rare human diseases with extreme traits, including diseases caused by mutations in ion channels, known as channelopathies. Xenon's Extreme Genetics® platform has yielded the first approved gene therapy product in the
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 timing of IND or IND equivalent submissions with regulatory agencies; the initiation of future clinical trials; potential efficacy, future development plans and commercial potential of our product candidates; the timing of the completion of and results from additional clinical trials and pre-clinical development activities; our achievement of certain milestones under our collaboration agreements; the plans of our collaboration partners and their interactions with regulatory agencies; the results of research and development efforts; the timing for identifying new pain targets in our existing collaboration with Genentech and announcing another proprietary drug discovery program and the sufficiency of our resources and capabilities to achieve our near-term goals. 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 Extreme Genetics 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; Glybera may have its conditional regulatory approval revoked or modified or may not attain adequate reimbursement coverage from third party payers; 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
The Xenon logo and "Extreme Genetics" are registered trademarks or trademarks of
|Xenon Pharmaceuticals Inc.|
|Condensed balance sheets|
|(Expressed in thousands of U.S. dollars except share data)|
|September 30,||December 31,|
|Cash and cash equivalents and marketable securities||$65,469||$84,041|
|Other current assets||645||901|
|Accounts payable and accrued expenses||$2,823||$2,664|
|Deferred revenue, current portion||2,513||11,622|
|Total liabilities and shareholders' equity||$69,944||$87,418|
|Xenon Pharmaceuticals Inc.|
|Condensed statements of operations|
|(Expressed in thousands of U.S. dollars except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||3,793||3,216||10,889||8,315|
|General and administrative||1,321||1,316||8,219||4,106|
|Total operating expenses||5,114||4,532||19,108||12,421|
|Income (loss) from operations||(820)||8,661||(6,758)||11,071|
|Other income (expense)||(3,007)||530||(5,057)||723|
|Net income (loss)||(3,827)||9,191||(11,815)||11,794|
|Net income attributable to participating securities||--||5,596||--||8,199|
|Net income (loss) attributable to common shareholders||$(3,827)||$3,595||$(11,815)||$3,595|
|Net loss per share attributable to common shareholders:|
|Weighted-average shares outstanding:|
Ian Mortimer Chief Financial Officer and Chief Operating Officer Xenon Pharmaceuticals Inc.Phone: 604.484.3300 Email: email@example.com