Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today reported financial results for the
second quarter ended June 30, 2023 and provided a corporate update.
Mr. Ian Mortimer, Xenon’s President and Chief
Executive Officer, stated, “We are pleased to announce that patient
enrollment is complete in our XEN1101 Phase 2 “X-NOVA" study in
major depressive disorder, or MDD. We expect the last patient to be
randomized in the near term and anticipate more than 160 total
patients will be randomized, which exceeds our planned target of
150 patients. We look forward to X-NOVA topline data in late
November to mid-December. In advance of these results, we will be
hosting a webinar in mid-September to review the MDD landscape and
the potential of the Kv mechanism to treat MDD as well as details
on our X-NOVA clinical trial.”
Mr. Mortimer continued, “We are also excited about
the advancements across our broad XEN1101 Phase 3 epilepsy program,
including continued progress in our X-TOLE2 and X-TOLE3 clinical
trials in patients with focal onset seizures and in our X-ACKT
clinical trial in patients with primary generalized tonic-clonic
seizures. Lastly, we are 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 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. Patient enrollment has been
completed in the X-NOVA study, with topline results anticipated in
late November to mid-December 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.
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 has completed patient enrollment in 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.
Second Quarter 2023 Financial
Results
Cash and cash equivalents and marketable
securities were $652.2 million as of June 30, 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 June 30, 2023, there were 63,718,350
common shares and 2,253,858 pre-funded warrants outstanding.
No revenue was recognized for the quarter ended
June 30, 2023 compared to $0.5 million of research and development
services revenue under the Neurocrine Biosciences collaboration for
the same period in 2022. The research component under the
Neurocrine Biosciences collaboration ended in June 2022.
Research and development expenses for the quarter
ended June 30, 2023 were $44.0 million, compared to $22.1 million
for the same period in 2022. The increase of $21.9 million was
primarily attributable to increased expenses related to our XEN1101
program to support the Phase 3 epilepsy clinical trials, the
ongoing X-NOVA Phase 2 MDD 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 for the
quarter ended June 30, 2023 were $11.6 million, compared to $8.7
million for the same period in 2022. The increase of $2.9 million
was primarily attributable to personnel-related costs due to an
increase in employee headcount and stock-based compensation.
Other income for the quarter ended June 30, 2023
was $7.9 million, compared to other expense of $0.9 million for the
same period in 2022. The change was primarily attributable to an
increase in interest income, as well as an unrealized fair value
gain on trading securities recognized in 2023, compared to an
unrealized fair value loss for the same period in 2022.
Net loss for the quarter ended June 30, 2023 was
$47.5 million, compared to $31.2 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 XEN1101 Phase 3 epilepsy clinical trials, and
increased employee headcount and higher stock-based compensation
expense across the organization, partially offset by an increase in
other income.
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
second 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 7071952. 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
pandemics, epidemics and other public health crises 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; 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)
|
|
June
30, |
|
|
December
31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents and marketable securities |
|
$ |
539,600 |
|
|
$ |
592,087 |
|
Other current assets |
|
|
5,016 |
|
|
|
8,211 |
|
Marketable
securities, long-term |
|
|
112,592 |
|
|
|
128,682 |
|
Other long-term assets |
|
|
27,691 |
|
|
|
25,166 |
|
Total assets |
|
$ |
684,899 |
|
|
$ |
754,146 |
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
26,936 |
|
|
$ |
22,214 |
|
Other current liabilities |
|
|
1,223 |
|
|
|
488 |
|
Other long-term liabilities |
|
|
10,283 |
|
|
|
9,947 |
|
Total liabilities |
|
$ |
38,442 |
|
|
$ |
32,649 |
|
|
|
|
|
|
|
|
Shareholders’ equity |
|
$ |
646,457 |
|
|
$ |
721,497 |
|
Total liabilities and shareholders’ equity |
|
$ |
684,899 |
|
|
$ |
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 Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
— |
|
|
$ |
536 |
|
|
$ |
— |
|
|
$ |
9,302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
44,040 |
|
|
|
22,146 |
|
|
|
83,556 |
|
|
|
41,506 |
|
General and administrative |
|
|
11,584 |
|
|
|
8,705 |
|
|
|
21,119 |
|
|
|
15,480 |
|
Total operating expenses |
|
|
55,624 |
|
|
|
30,851 |
|
|
|
104,675 |
|
|
|
56,986 |
|
Loss from operations |
|
|
(55,624) |
|
|
|
(30,315) |
|
|
|
(104,675) |
|
|
|
(47,684) |
|
Other income (expense) |
|
|
7,943 |
|
|
|
(883) |
|
|
|
15,557 |
|
|
|
(3,578) |
|
Loss before income taxes |
|
|
(47,681) |
|
|
|
(31,198) |
|
|
|
(89,118) |
|
|
|
(51,262) |
|
Income tax recovery (expense) |
|
|
220 |
|
|
|
40 |
|
|
|
(70) |
|
|
|
434 |
|
Net loss |
|
|
(47,461) |
|
|
|
(31,158) |
|
|
|
(89,188) |
|
|
|
(50,828) |
|
Net loss attributable to preferred shareholders |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(385) |
|
Net loss attributable to common shareholders |
|
$ |
(47,461) |
|
|
$ |
(31,158) |
|
|
$ |
(89,188) |
|
|
$ |
(50,443) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on available-for-sale securities |
|
$ |
(1,479) |
|
|
$ |
— |
|
|
$ |
(299) |
|
|
$ |
— |
|
Comprehensive loss |
|
$ |
(48,940) |
|
|
$ |
(31,158) |
|
|
$ |
(89,487) |
|
|
$ |
(50,443) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.72) |
|
|
$ |
(0.55) |
|
|
$ |
(1.36) |
|
|
$ |
(0.91) |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
65,861,138 |
|
|
|
56,192,922 |
|
|
|
65,792,910 |
|
|
|
55,522,857 |
|
Investor/Media Contact: Jodi
Regts Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email:
investors@xenon-pharma.com
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