Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today reported financial results for the
first quarter ended March 31, 2023 and provided a corporate update.
Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer,
stated, “Our XEN1101 program has continued to build momentum with
all planned Phase 3 clinical trials now actively recruiting
patients, including X-TOLE2 and X-TOLE3 in patients with focal
onset seizures and X-ACKT in patients with primary generalized
tonic-clonic seizures. We are excited about the continued progress
in our broad Phase 3 program, supported by a robust data package
and validated mechanism, including efficacy data from our Phase 2b
X-TOLE clinical trial and read-outs from our ongoing open-label
extension study.
Mr. Mortimer continued, “Based on FDA feedback on our pediatric
development plans for XEN1101, we expect to expand the X-ACKT Phase
3 clinical trial to include patients as young as 12 years of age.
In addition, XEN1101 pediatric formulation development is ongoing
in order to support moving into younger patients with epilepsy.
After careful consideration, we are prioritizing our XEN1101
pediatric epilepsy development plans and will no longer pursue the
clinical development of XEN496. We wish to extend our sincere
gratitude to the patients and their families who participated in
the EPIK clinical trial. We intend to work with study investigators
to offer an option for continued access through a transition period
for those patients currently on XEN496.”
Mr. Mortimer added, “We continue to make good progress on our
XEN1101 Phase 2 X-NOVA study in major depressive disorder. We
expect patient screening to be completed in June with the release
of topline data in the fourth quarter. We are also looking forward
to a read-out from our Phase 2 partnered program with Neurocrine in
the fourth quarter of this year.”
Highlights and Anticipated
Milestones
XEN1101
XEN1101 is a differentiated Kv7 potassium channel opener being
developed for the treatment of epilepsy and other neurological
disorders, including major depressive disorder, or MDD.
XEN1101 for Epilepsy (Focal
Onset Seizures)
Xenon’s XEN1101 Phase 3 epilepsy
program includes two identical Phase 3 clinical trials, called
X-TOLE2 and X-TOLE3, that are designed closely after the Phase 2b
X-TOLE clinical trial. These multicenter, randomized, double-blind,
placebo-controlled trials are evaluating the clinical efficacy,
safety, and tolerability of XEN1101 administered as adjunctive
treatment in approximately 360 patients per study with focal onset
seizures, or FOS. The primary efficacy endpoint is the median
percent change, or MPC, in monthly seizure frequency from baseline
through the double-blind period, or DBP, of XEN1101 compared to
placebo.
XEN1101 for Epilepsy (Primary
Generalized Tonic-Clonic Seizures)
Xenon’s Phase 3 X-ACKT clinical trial
is intended to support potential regulatory submissions in an
additional epilepsy indication of primary generalized tonic-clonic
seizures, or PGTCS. This multicenter, randomized, double-blind,
placebo-controlled study is evaluating the clinical efficacy,
safety, and tolerability of XEN1101 administered as adjunctive
treatment in approximately 160 patients with PGTCS. The primary
efficacy endpoint is the MPC in monthly PGTCS frequency from
baseline through the DBP of XEN1101 compared to placebo.
Upon completion of the DBP in
X-TOLE2, X-TOLE3, or X-ACKT, eligible patients may enter an
open-label extension, or OLE, study for up to three years. In
addition, the ongoing X-TOLE Phase 2b OLE continues to generate
important long-term data for XEN1101.
XEN1101 for Major Depressive
Disorder
Based on promising pre-clinical data
with XEN1101 and published clinical data generated using ezogabine,
Xenon is evaluating the clinical efficacy, safety and tolerability
of XEN1101 administered as monotherapy in approximately 150
patients with MDD in a Phase 2 clinical trial called X-NOVA.
Designed as a randomized, double-blind, placebo-controlled,
multicenter clinical study, the primary objective is to assess the
efficacy of XEN1101 compared to placebo on improvement of
depressive symptoms in subjects diagnosed with moderate to severe
MDD, using the Montgomery-Åsberg Depression Rating Scale, or MADRS,
score change through week six. The last patient in the X-NOVA study
is expected to be screened in June 2023, with topline results
anticipated in the fourth quarter of this year.
In addition, Xenon is collaborating
with the Icahn School of Medicine at Mount Sinai to support an
ongoing investigator-sponsored Phase 2 proof-of-concept,
randomized, parallel-arm, placebo-controlled multi-site study of
XEN1101 for the treatment of MDD in approximately 60 subjects.
XEN496
XEN496, a Kv7 potassium channel opener, is a proprietary
pediatric formulation of the active ingredient ezogabine. Given the
prioritized focus on the pediatric development plans for XEN1101,
Xenon will no longer pursue the clinical development of XEN496. For
all patients currently on XEN496, Xenon intends to work with study
investigators to offer an option for continued access to XEN496
through a transition period.
NBI-921352
Xenon has an ongoing collaboration with Neurocrine Biosciences
to develop treatments for epilepsy. Neurocrine Biosciences has an
exclusive license to XEN901, now known as NBI-921352, a selective
Nav1.6 sodium channel inhibitor. Neurocrine Biosciences is
conducting a Phase 2 clinical trial evaluating NBI-921352 in adult
patients with focal onset seizures, with data expected in the
fourth quarter of this year. In addition, a Phase 2 clinical trial
is underway evaluating NBI-921352 in patients aged between 2 and 21
years with SCN8A developmental and epileptic encephalopathy, or
SCN8A-DEE. Pursuant to the terms of the agreement, Xenon has the
potential to receive certain clinical, regulatory, and commercial
milestone payments, as well as future sales royalties.
First Quarter 2023 Financial
Results
Cash and cash equivalents and marketable securities were $687.3
million as of March 31, 2023, compared to $720.8 million as of
December 31, 2022. Based on current operating plans, including the
completion of the XEN1101 Phase 3 epilepsy studies, Xenon
anticipates having sufficient cash to fund operations into 2026. As
of March 31, 2023, there were 63,107,020 common shares and
2,678,861 pre-funded warrants outstanding.
No revenue was recognized in the first quarter of 2023, compared
to $8.8 million for the same period in 2022. The decrease was
primarily due to the Neurocrine Biosciences collaboration; a $7.1
million milestone was recognized in the quarter ended March 31,
2022, whereas no milestones were recognized for the same period in
2023 and the research component of the collaboration ended in June
2022.
Research and development expenses were $39.5 million for the
first quarter of 2023, compared to $19.4 million for the same
period in 2022. The increase of $20.2 million was primarily
attributable to increased expenses related to our XEN1101 program
to support the Phase 3 epilepsy clinical trials, the ongoing Phase
2 X-NOVA clinical trial, as well as increased personnel-related
costs due to an increase in employee headcount and stock-based
compensation expense.
General and administrative expenses were $9.5 million for the
first quarter of 2023, compared to $6.8 million for the same period
in 2022. The increase of $2.8 million was primarily attributable to
personnel-related costs due to an increase in employee headcount
and stock-based compensation, legal compliance fees and market
research costs.
Other income was $7.6 million for the first quarter of 2023,
compared to other expense of $2.7 million for the same period in
2022. The change was primarily attributable to an unrealized fair
value gain on trading securities recognized in 2023, compared to an
unrealized fair value loss for the same period in 2022, as well as
an increase in interest income.
Net loss was $41.7 million for the first quarter of 2023,
compared to $19.7 million for the same period in 2022. The increase
in net loss was primarily attributable to higher operating
expenses, driven by research and development expenses related to
the Company’s XEN1101 Phase 3 epilepsy clinical trials, increased
employee headcount and higher stock-based compensation expense
across the organization as well as lower revenue from the
collaboration with Neurocrine Biosciences.
Conference Call Information
Xenon will host a conference call and webcast today at 4:30 pm
Eastern Time (1:30 pm Pacific Time) to discuss its first quarter
2023 results. The audio webcast can be accessed on the Investors
section of the Xenon website. Participants can access the live
conference call by dialing (800) 715-9871, or (646) 307-1963 for
international callers, and provide conference ID number 4092363. A
replay of the webcast will be available on the website
approximately one hour after the conclusion of the event and will
be archived for approximately one month.
About Xenon Pharmaceuticals
Inc.
Xenon Pharmaceuticals (NASDAQ:XENE) is a
clinical stage biopharmaceutical company committed to developing
innovative therapeutics to improve the lives of patients with
neurological disorders. We are advancing a novel product pipeline
of neurology therapies to address areas of high unmet medical need,
with a focus on 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, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, 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 and potential results from clinical trials;
the potential efficacy, safety profile, future development plans,
addressable market, regulatory success and commercial potential of
our and our partners’ product candidates; the efficacy of our
clinical trial designs; our ability to successfully develop and
achieve milestones in our XEN1101 and other development programs;
the timing and results of our interactions with regulators; our
ability to successfully develop and obtain regulatory approval of
XEN1101 and our other product candidates; anticipated enrollment in
our clinical trials and the timing thereof; and our expectation
that we will have sufficient cash to fund operations into 2026.
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; promising results from
pre-clinical development activities or early clinical trial results
may not be replicated in later clinical trials; our assumptions
regarding our planned expenditures and sufficiency of our cash to
fund operations may be incorrect; our ongoing discovery and
pre-clinical efforts may not yield additional product candidates;
any of our or our collaborators’ product candidates, including
XEN1101, 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
impose additional requirements or delay the initiation of clinical
trials; the impact of competition; the impact of expanded product
development and clinical activities on operating expenses; the
impact of new or changing laws and regulations; the impact of the
ongoing COVID-19 pandemic on our research and clinical development
plans and timelines and results of operations, including impact on
our clinical trial sites, collaborators, regulatory agencies and
related review times, and contractors who act for or on our behalf,
may be more severe and more prolonged than currently anticipated;
the impact of unstable economic conditions in the general domestic
and global economic markets; adverse conditions from geopolitical
events; 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.
XENON PHARMACEUTICALS INC.Condensed Consolidated
Balance Sheets(Expressed in thousands of U.S. dollars)
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents and marketable securities |
|
$ |
527,043 |
|
|
$ |
592,087 |
|
Other current assets |
|
|
6,308 |
|
|
|
8,211 |
|
Marketable securities,
long-term |
|
|
160,265 |
|
|
|
128,682 |
|
Other long-term assets |
|
|
26,252 |
|
|
|
25,166 |
|
Total assets |
|
$ |
719,868 |
|
|
$ |
754,146 |
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
21,297 |
|
|
$ |
22,214 |
|
Other current liabilities |
|
|
1,194 |
|
|
|
488 |
|
Other long-term liabilities |
|
|
10,433 |
|
|
|
9,947 |
|
Total liabilities |
|
$ |
32,924 |
|
|
$ |
32,649 |
|
|
|
|
|
|
|
|
Shareholders’ equity |
|
$ |
686,944 |
|
|
$ |
721,497 |
|
Total liabilities and shareholders’ equity |
|
$ |
719,868 |
|
|
$ |
754,146 |
|
XENON PHARMACEUTICALS INC.Condensed Consolidated
Statements of Operations and Comprehensive Loss(Expressed in
thousands of U.S. dollars except share and per share amounts)
|
Three Months EndedMarch 31, |
|
|
2023 |
|
|
2022 |
|
Revenue |
$ |
— |
|
|
$ |
8,766 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
39,516 |
|
|
|
19,360 |
|
General and administrative |
|
9,535 |
|
|
|
6,775 |
|
Total operating expenses |
|
49,051 |
|
|
|
26,135 |
|
Loss from operations |
|
(49,051 |
) |
|
|
(17,369 |
) |
Other income (expense) |
|
7,614 |
|
|
|
(2,695 |
) |
Loss before income taxes |
|
(41,437 |
) |
|
|
(20,064 |
) |
Income tax (expense) recovery |
|
(290 |
) |
|
|
394 |
|
Net
loss |
|
(41,727 |
) |
|
|
(19,670 |
) |
Net loss attributable to preferred shareholders |
|
— |
|
|
|
(299 |
) |
Net loss attributable to common shareholders |
$ |
(41,727 |
) |
|
$ |
(19,371 |
) |
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
Unrealized gain on available-for-sale securities |
$ |
1,180 |
|
|
$ |
— |
|
Comprehensive loss |
$ |
(40,547 |
) |
|
$ |
(19,670 |
) |
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
Basic and diluted |
$ |
(0.63 |
) |
|
$ |
(0.35 |
) |
Weighted-average common shares outstanding: |
|
|
|
|
|
Basic and diluted |
|
65,724,681 |
|
|
|
54,852,792 |
|
Investor/Media Contact:Jodi RegtsXenon
Pharmaceuticals Inc.Phone: 604.484.3353Email:
investors@xenon-pharma.com
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