Xenon Pharmaceuticals Reports First Quarter 2015 Financial Results and Provides Corporate Update
Continued Pipeline Progress in Partnered and Proprietary Programs
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 osteoarthritis. Results from the trial are expected in the third quarter of 2015. TV-45070 is a topically applied small-molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system.
- Teva recently initiated patient enrollment in a Phase 2b clinical trial of TV-45070 in patients with PHN, with results expected in the second half of 2016.
Xenon's partner Genentech, a member of the
Roche Group(SIX:RO) (SIX:ROG) (OTCQX:RHHBY), is currently conducting a Phase 1 clinical trial for GDC-0276, which is expected to complete patient enrollment in the second half of 2015. GDC-0276 is a selective, oral Nav1.7 small-molecule inhibitor being developed for the treatment of pain.
- 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. A key goal of this collaboration is to identify new pain targets for drug discovery in 2015.
Glybera: First Commercial Launch in
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. uniQure reports that while Chiesi believes the first patient may receive treatment by mid-2015, the ultimate timing is subject to several factors including the treating physician's decision and relevant patient consent. 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.
Xenon's Proprietary Programs
XEN801, is a stearoyl Co-A desaturase, or SCD1 inhibitor, for the treatment of acne. Xenon expects to file an investigational new drug, or IND, equivalent application to initiate a Phase 1 clinical trial in mid-2015. If supported by positive data from the Phase 1 trial, Xenon plans to initiate a proof-of-concept Phase 2 clinical trial in the second half of 2015. It is estimated that in
the United Statesthere are approximately 11 million people with moderate acne and 1.2 million people with 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 the orphan disorder Dravet Syndrome continues to progress and Xenon expects to file an IND application in 2016. Dravet Syndrome is an orphan disease of severe childhood epilepsy, and represents a high unmet medical need, affecting 7,500-15,000 patients in
the United States. 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 selecting its next drug discovery target in 2015 by leveraging its Extreme Genetics® discovery platform and expertise in ion channel chemistry and biology.
First 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 the quarter ended
Other expense was
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 40757543. 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, the timing of and results from ongoing clinical trials and pre-clinical development activities, the commercial launch of Glybera in the
The Xenon logo and "Extreme Genetics" are registered trademarks or trademarks of
|Xenon Pharmaceuticals Inc.|
|Condensed consolidated balance sheets|
|(Expressed in thousands of U.S. dollars except share data)|
|March 31,||December 31,|
|Cash and cash equivalents and marketable securities||$75,381||$84,041|
|Other current assets||1,669||901|
|Accounts payable and accrued expenses||$1,530||$2,664|
|Deferred revenue, current portion||8,724||11,622|
|Total liabilities and shareholders' equity||$79,403||$87,418|
|Xenon Pharmaceuticals Inc.|
|Condensed consolidated statements of operations|
|(Expressed in thousands of U.S. dollars except share and per share data)|
|Three Months Ended March 31,|
|Research and development||3,427||2,533|
|General and administrative||1,789||1,436|
|Total operating expenses||5,216||3,969|
|Income (loss) from operations||(1,206)||1,032|
|Other income (expense)||(3,019)||341|
|Net income (loss)||(4,225)||1,373|
|Net income attributable to participating securities||--||1,373|
|Net loss attributable to common shareholders||$(4,225)||$ --|
|Net loss per share attributable to common shareholders:|
|Basic and diluted||$(0.30)||$ --|
Weighted-average shares outstanding:
|Basic and diluted||14,212,579||1,345,312|
Ian Mortimer Chief Financial Officer and Chief Operating Officer Xenon Pharmaceuticals Inc.Phone: 604.484.3300 Email: email@example.com