Xenon Pharmaceuticals Reports Second Quarter 2016 Financial Results and Provides Corporate Update
Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, said, “Our proprietary programs continue to advance as we make strong progress towards our corporate milestones. We have now surpassed 50% enrollment in our XEN801 Phase 2 clinical trial in patients with moderate to severe acne, and based on updated projections, we anticipate a read out of top-line results in the first quarter of 2017. Within our preclinical Nav1.6 program, we are working with numerous potent, selective Nav1.6 inhibitors that have demonstrated efficacy for seizures in preclinical models, supporting the hypothesis that inhibiting the Nav1.6 channel could play a key role in treating rare and severe forms of childhood epilepsy. We expect to file an investigational new drug (IND) application in the first half of 2017.”
Dr. Pimstone added, “Our pain-focused collaborations with Teva and Genentech also continue to progress well as we work to translate the therapeutic potential of the Nav1.7 target into novel pain therapeutics. These partnerships allow us to address large market opportunities, while at the same time enable us to pursue multiple therapeutic opportunities to build out our proprietary pipeline of novel therapies that address rare or orphan indications.”
Achievements and Anticipated Milestones
- XEN801 is a topical stearoyl Co-A desaturase-1, or SCD1 inhibitor, being developed for the treatment of moderate to severe acne. By targeting a reduction in the size and number of sebaceous glands, thereby reducing sebum production, Xenon believes XEN801 is a promising, novel treatment for acne, which could be better tolerated and without the serious side effects that often limit the use of currently approved retinoid treatments. We have currently enrolled approximately half of the patients in our ongoing XEN801 Phase 2 clinical trial, which is a randomized, double-blind, multi-center, vehicle-controlled, parallel-group study designed to evaluate the efficacy, safety, tolerability and systemic exposure of XEN801 for the treatment of moderate to severe facial acne. Xenon expects to enroll approximately 150 patients with moderate to severe acne, with topline results expected in the first quarter of 2017.
Xenon presented data from the XEN801 Phase 1 clinical trial where 48 healthy volunteers were dosed for either a 14-day or 21-day treatment period. A number of different dose volumes of the 1% XEN801 drug product were evaluated in the Phase 1 clinical trial with dosing on the back and face of healthy volunteers to determine the maximum tolerated dose. As expected, the most common side effects were localized, generally mild skin reactions. No serious adverse events were observed. Maximal plasma concentrations of XEN801 were low, whereas skin biopsies from the back of subjects showed a concentration of approximately two orders of magnitude higher than the IC50 and higher than that required for 100% block of SCD1. It is expected that XEN801 could achieve even better penetration in the facial skin, as currently applied in the current Phase 2 clinical trial. A Phase 2 dose was selected based on favorable tolerability and skin drug concentrations.
- Xenon's development of a Nav1.6 sodium channel inhibitor for the treatment of rare infantile epileptic encephalopathies – such as Dravet Syndrome and SCN8A (Nav1.6 gain-of-function) Epilepsy – continues to progress well. Xenon has identified potent, selective Nav1.6 inhibitors, and encouraging results from in vivo animal studies indicate that selective Nav1.6 inhibitors have demonstrated efficacy for seizures in a model of Nav1.6 gain-of-function SCN8A epilepsy, supporting the hypothesis that SCN8A epilepsies can be treated with potent, selective Nav1.6 inhibitors. Xenon expects to identify a development candidate in 2016 and file an investigational new drug (IND) application in the first half of 2017.
- Xenon continues to leverage its drug discovery platform to identify validated drug targets and develop new product candidates, and expects to provide updates as new drug discovery programs advance in 2016.
- TV-45070 is a product candidate being developed in collaboration with Xenon’s partner,
Teva Pharmaceutical Industries Ltd., for the treatment of pain. Teva is currently 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 first half of 2017.
- Xenon's partner Genentech, a member of the
Roche Group, is currently conducting two Phase 1 clinical trials for GDC-0276 and GDC-0310, which are both oral, selective Nav1.7 small-molecule inhibitors being developed for the potential treatment of pain. Both Phase 1 clinical trials are ongoing, and pending a full assessment of the results, Genentech intends to initiate a Phase 2 clinical trial in late 2016 or early 2017. The research term for Xenon’s second collaboration with Genentech, which is centered on pain genetics, was recently extended for another year until March 2017.
- Xenon is eligible to receive a royalty on commercial sales of Glybera, which is licensed to uniQure
Biopharma B.V.for the treatment of the orphan disorder lipoprotein lipase deficiency. The first patient treated with Glybera as a commercially-available gene therapy was announced by uniQure in November 2015and enabled by its commercialization partner in the EU, Chiesi Farmaceutici S.p.A.
Second Quarter 2016 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 4:30 p.m. Eastern Time (
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 our ability to achieve milestones in both our proprietary and partnered development programs, the anticipated enrollment in the Phase 2 clinical trial of XEN801, the anticipated timing of IND 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 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; 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,” 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)|
|June 30,||December 31,|
|Cash and cash equivalents and marketable securities||$||50,738||$||58,651|
|Other current assets||2,654||2,215|
|Accounts payable and accrued expenses||2,929||2,625|
|Total liabilities and shareholders’ equity||$||55,687||$||63,949|
|XENON PHARMACEUTICALS INC.|
|Condensed 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||5,103||3,669||9,467||7,096|
|General and administrative||1,676||178||3,571||6,898|
|Loss from operations||(6,366||)||199||(12,024||)||(5,938||)|
|Other income (expense)||350||969||2,745||(2,050||)|
|Net income (loss)||$||(6,016||)||$||1,168||$||(9,279||)||$||(7,988||)|
|Net income (loss) per common share:|
|Weighted-average shares outstanding:|
Jodi RegtsSenior Director, Corporate Affairs Xenon Pharmaceuticals Inc.Phone: 604.484.3353 Email: email@example.com