Xenon Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update
Topline data from XEN1101 Phase 2 X-NOVA clinical trial in major depressive disorder on track for late November to mid-December
XEN1101 Phase 3 epilepsy program continues to progress with X-TOLE2 and X-TOLE3 in focal onset seizures and X-ACKT in primary generalized tonic-clonic seizures
Patient enrollment in X-TOLE2 expected to complete in the second half of 2024
Conference call at
Mr.
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
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
No revenue was recognized 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 webcast today at
About
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
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Condensed Consolidated Balance Sheets
(Expressed in thousands of
| 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 | ||||
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Expressed in thousands of
| Three Months Ended |
Nine Months Ended |
|||||||||||||||
| 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:
Phone: 604.484.3353
Email: investors@xenon-pharma.com
Source: Xenon Pharmaceuticals Inc.