Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused
biopharmaceutical company, today reported financial results for the
third quarter ended September 30, 2023 and provided a corporate
update.
Mr. Ian Mortimer, Xenon’s President and Chief
Executive Officer, stated, “We are excited by the progress that we
have made across our broad XEN1101 program, including the
publication of a peer-reviewed article in the prestigious JAMA
Neurology journal summarizing our Phase 2b X-TOLE study of XEN1101
in adults with focal epilepsy. We also recently presented new
interim data from our ongoing open-label extension study from our
Phase 2b X-TOLE trial at the International Epilepsy Congress,
demonstrating that the long-term efficacy of XEN1101 translates
into overall improvements in patients’ quality of life.
Importantly, we also continue to execute on our ambitious Phase 3
epilepsy program – including X-TOLE2 and X-TOLE3 in patients with
focal onset seizures and X-ACKT in patients with primary
generalized tonic-clonic seizures – with patient enrollment in
X-TOLE2 expected to complete in the second half of next year.”
Mr. Mortimer continued, “In the near-term, we are
looking forward to the topline read-out from our XEN1101 Phase 2
X-NOVA study in major depressive disorder, or MDD, in late November
to mid-December. In addition, our collaborators at Neurocrine have
guided that data from its NBI-921352 adult focal study are
anticipated this month.”
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 15 mg or 25 mg 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. Xenon anticipates that patient
enrollment in X-TOLE2 will be completed in the second half of
2024.
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 25 mg 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.
XEN1101 for
Epilepsy (Open-Label Extension)
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 10 mg or 20 mg 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 November. 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.
Third Quarter 2023 Financial
Results
Cash and cash equivalents and marketable
securities were $639.1 million as of September 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 September 30, 2023, there were
65,002,249 common shares and 1,828,854 pre-funded warrants
outstanding.
No revenue was recognized for the quarter ended
September 30, 2023 compared to $0.1 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 September 30, 2023 were $42.9 million, compared to $29.4
million for the same period in 2022. The increase of $13.4 million
was primarily attributable to increased expenses related to Xenon's
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. These increases were
partially offset by a decrease in spend on the XEN496 program as a
result of Xenon's decision to no longer pursue the clinical
development of XEN496.
General and administrative expenses for the
quarter ended September 30, 2023 were $12.8 million, compared to
$8.8 million for the same period in 2022. The increase of $4.0
million was primarily attributable to personnel-related costs due
to an increase in employee headcount and stock-based compensation,
and professional and consulting fees.
Other income for the quarter ended September 30,
2023 was $7.1 million, compared to $0.4 million for the same period
in 2022. The change was primarily attributable to an increase in
interest income, a lower foreign exchange loss, 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 September 30, 2023
was $48.5 million, compared to $37.2 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 personnel-related costs 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
third 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 4249948. 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)
|
|
September
30, |
|
|
December
31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents and marketable securities |
|
$ |
526,674 |
|
|
$ |
592,087 |
|
Other current assets |
|
|
4,334 |
|
|
|
8,211 |
|
Marketable
securities, long-term |
|
|
112,407 |
|
|
|
128,682 |
|
Other long-term assets |
|
|
27,678 |
|
|
|
25,166 |
|
Total assets |
|
$ |
671,093 |
|
|
$ |
754,146 |
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
23,498 |
|
|
$ |
22,214 |
|
Other current liabilities |
|
|
1,246 |
|
|
|
488 |
|
Other long-term liabilities |
|
|
9,757 |
|
|
|
9,947 |
|
Total liabilities |
|
$ |
34,501 |
|
|
$ |
32,649 |
|
|
|
|
|
|
|
|
Shareholders’ equity |
|
$ |
636,592 |
|
|
$ |
721,497 |
|
Total liabilities and shareholders’ equity |
|
$ |
671,093 |
|
|
$ |
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 September
30, |
|
|
Nine Months Ended September
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
— |
|
|
$ |
132 |
|
|
$ |
— |
|
|
$ |
9,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
42,880 |
|
|
|
29,431 |
|
|
|
126,436 |
|
|
|
70,937 |
|
General and administrative |
|
|
12,804 |
|
|
|
8,829 |
|
|
|
33,923 |
|
|
|
24,309 |
|
|
|
|
55,684 |
|
|
|
38,260 |
|
|
|
160,359 |
|
|
|
95,246 |
|
Loss from operations |
|
|
(55,684 |
) |
|
|
(38,128 |
) |
|
|
(160,359 |
) |
|
|
(85,812 |
) |
Other income (expense) |
|
|
7,065 |
|
|
|
391 |
|
|
|
22,622 |
|
|
|
(3,187 |
) |
Loss before income taxes |
|
|
(48,619 |
) |
|
|
(37,737 |
) |
|
|
(137,737 |
) |
|
|
(88,999 |
) |
Income tax recovery |
|
|
157 |
|
|
|
587 |
|
|
|
87 |
|
|
|
1,021 |
|
Net loss |
|
|
(48,462 |
) |
|
|
(37,150 |
) |
|
|
(137,650 |
) |
|
|
(87,978 |
) |
Net loss attributable to preferred shareholders |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(420 |
) |
Net loss attributable to common shareholders |
|
$ |
(48,462 |
) |
|
$ |
(37,150 |
) |
|
$ |
(137,650 |
) |
|
$ |
(87,558 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities |
|
$ |
346 |
|
|
$ |
(1,965 |
) |
|
$ |
47 |
|
|
$ |
(1,965 |
) |
Comprehensive loss |
|
$ |
(48,116 |
) |
|
$ |
(39,115 |
) |
|
$ |
(137,603 |
) |
|
$ |
(89,943 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.73 |
) |
|
$ |
(0.57 |
) |
|
$ |
(2.09 |
) |
|
$ |
(1.49 |
) |
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
66,002,163 |
|
|
|
65,465,069 |
|
|
|
65,862,661 |
|
|
|
58,836,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor/Media Contact: Jodi
Regts Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email:
investors@xenon-pharma.com
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