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Yahoo
7 days ago
- Business
- Yahoo
Xenon Pharmaceuticals Inc (XENE) Q2 2025 Earnings Call Highlights: Strategic Advances and ...
Cash and Cash Equivalents: $624.8 million as of June 30, 2025. Marketable Securities: Included in the cash and cash equivalents total. Cash Burn: Decrease from $754.4 million as of December 31, 2024, indicating cash used in operations. Funding Outlook: Sufficient cash to fund operations into 2027. Warning! GuruFocus has detected 3 Warning Signs with XENE. Release Date: August 11, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Xenon Pharmaceuticals Inc (NASDAQ:XENE) completed patient recruitment for the X-TOLE2 Phase 3 clinical trial, a significant milestone for the development of azetukalner. The company anticipates having sufficient cash to fund operations into 2027, demonstrating strong fiscal management. Azetukalner has shown promising results in Phase 2b trials with compelling placebo-adjusted efficacy in focal onset seizure patients. Xenon Pharmaceuticals Inc (NASDAQ:XENE) has initiated multiple Phase 3 studies for azetukalner in major depressive disorder and bipolar depression, expanding its clinical development program. The company has a strong presence in the epilepsy community, with plans to present data at upcoming international conferences, enhancing its scientific outreach and educational efforts. Negative Points The timeline for filing the NDA after the X-TOLE2 data readout is approximately six months, which may delay commercialization. There is uncertainty regarding the final number of patients to be randomized in the X-TOLE2 study, which could impact study outcomes. The company has not yet established a compassionate use program for azetukalner, despite interest from the medical community. Xenon Pharmaceuticals Inc (NASDAQ:XENE) faces potential challenges in the epilepsy market, including overcoming the inertia of established treatment practices. There are concerns about potential safety issues with the Nav1.7 program, although no cardiovascular signals have been observed in preclinical data. Q & A Highlights Q: Can you remind us how quickly you think you'll be able to file on the back of the top line FOS data? Also, could you talk about your confidence in the Nav1.7 program in pain regarding safety issues? A: We estimate approximately six months from topline data to filing the NDA for the X-TOLE2 data. Regarding the Nav1.7 program, we believe we have a good handle on potential safety issues, such as cardiovascular signals seen in earlier molecules. We haven't observed any cardiovascular signals in preclinical safety data and will monitor this in human clinical development. Q: For X-TOLE2, when do you expect all patients to be randomized, and what was the patient recruitment split US versus ex-US? A: We have completed patient recruitment for X-TOLE2, and the last patients will go through an eight-week baseline period before randomization. We haven't finalized the specific breakdown of US versus ex-US recruitment or the number of sites yet, but we aim to maintain consistency with the X-TOLE study. Q: Have you seen any compassionate use interest for azetukalner? A: Yes, there is constant interest in compassionate use for azetukalner, not just within neurology and psychiatry but beyond. We are having active discussions about when a compassionate use program could be implemented. Q: How are you thinking about the potential difference in dose response for the 15 and 25 mg doses in the Phase 3 study versus the Phase 2? A: We expect to see a dose response between 15 mg and 25 mg in the Phase 3 program, similar to the clear dose response observed in Phase 2. Our discussions with the FDA suggest having multiple doses on label to provide flexibility to the epilepsy community. Q: On the Nav1.7 program, once you establish proof of concept, would you consider exploring combinations with a Nav1.8? A: We are excited about the leadership position in Nav1.7 and are focused on establishing proof of concept. Long-term, we may consider different combinations of non-opioid mechanisms, including Nav1.8, but it's early to start planning those combinations. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
11-08-2025
- Business
- Yahoo
Xenon Reports Second Quarter 2025 Financial Results & Business Update
– Phase 3 azetukalner X-TOLE2 FOS study patient recruitment complete, with topline data anticipated in early 2026– Phase 3 azetukalner neuropsychiatric studies underway with X-NOVA3 in MDD and X-CEED in BPD recently initiated– Phase 1 healthy volunteer study initiated for lead Nav1.7 development candidate for pain– Darren Cline appointed as Chief Commercial Officer to lead commercial build and anticipated azetukalner launch– Conference call at 4:30 pm ET today VANCOUVER, British Columbia and BOSTON, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. 'The completion of patient recruitment for our Phase 3 X-TOLE2 study is a significant milestone in the development of azetukalner and keeps us on track to report topline results in early 2026 in anticipation of our first potential approval and commercial product as a company. We remain highly encouraged by the potential value proposition of azetukalner as a novel, next-generation treatment option for people living with the debilitating effects of uncontrolled seizures,' said Ian Mortimer, President and Chief Executive Officer of Xenon. 'In addition, we remain excited about azetukalner's potential beyond epilepsy, with Phase 3 programs underway across multiple neuropsychiatric indications, with the initiation of our Phase 3 X-CEED study in bipolar depression, alongside two clinical studies now underway in our ongoing Phase 3 X-NOVA program in major depressive disorder.' 'We also continue to make significant progress within our early-stage portfolio, advancing multiple drug candidates targeting promising sodium and potassium channel targets, and we are currently conducting two first-in-human studies within our Kv7 and Nav1.7 programs. As we enter this catalyst-rich period, we remain focused on advancing and delivering innovative therapeutics to patients living with epilepsy, depression, and pain.' continued Mr. Mortimer. Business Highlights and Anticipated Milestones Azetukalner Clinical Development Azetukalner, a novel, highly potent, selective Kv7 potassium channel opener, represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for the treatment of multiple indications that include epilepsy, including focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS), as well as neuropsychiatric disorders including major depressive disorder (MDD) and bipolar depression (BPD). Epilepsy Programs Phase 3 X-TOLE2 clinical study of azetukalner in FOS has now completed patient recruitment, with topline data anticipated in early 2026. Phase 3 X-TOLE3 clinical study of azetukalner in FOS continues to enroll patients and is intended to support potential regulatory submissions in ex-U.S. jurisdictions. Phase 3 X-ACKT clinical study of azetukalner in PGTCS continues to enroll patients and is intended to support regulatory submissions for an additional epilepsy indication. The Company had four abstracts accepted to present at the 36th International Epilepsy Congress (IEC) taking place August 30 to September 3, 2025 in Lisbon, Portugal. Neuropsychiatric Programs X-NOVA2 and X-NOVA3, the first two of three planned Phase 3 clinical trials evaluating azetukalner in patients with MDD, are now underway and screening patients. X-CEED, the first of two planned Phase 3 clinical studies evaluating azetukalner in patients with BPD I and BPD II depression, has been initiated. Early-Stage Pipeline: Next-Generation Ion Channel Modulators Xenon continues to expand its portfolio by leveraging its extensive expertise to discover and develop potassium and sodium channel therapeutics, with the goal of filing multiple INDs, or equivalent, in 2025. Phase 1 study in healthy adult participants is underway for XEN1120, a Kv7 channel opener in development for pain. Work remains ongoing with additional Kv7 development molecules and chemistries with the hypothesis that Kv7 may have utility in a broad range of therapeutic indications including seizure disorders, pain, and neuropsychiatric disorders, such as MDD and BPD. Phase 1 study was initiated for XEN1701, the Company's lead Nav1.7 development candidate for pain. IND-enabling work remains ongoing for additional Nav1.7 candidates. Nav1.7 is an important pain-related target, based on strong human genetic validation, which may represent a new class of medicines without the limitations of opioids. Nav1.1 lead candidate is expected to enter IND-enabling studies in 2025, with pre-clinical data suggesting that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet Syndrome. Xenon plans to host multiple R&D webinars with focus on early-stage pipeline programs. The first webinar will take place on October 2, 2025, and focus on our approach to treating pain with drug candidates targeting Nav1.7 and Kv7. Partnered Program As part of Xenon's ongoing collaboration with Neurocrine Biosciences, a Phase 1 study is underway for NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 in development for the potential treatment of certain types of epilepsy. Corporate The Company appointed Darren Cline to Chief Commercial Officer (CCO). Cline brings extensive commercial expertise to lead the transition of Xenon to a commercial-stage company with the anticipated launch of azetukalner across three potential indications. Second Quarter Financial Results Cash and cash equivalents and marketable securities were $624.8 million as of June 30, 2025, compared to $754.4 million as of December 31, 2024. Based on current operating plans, including the completion of the azetukalner Phase 3 epilepsy studies and supporting late-stage clinical development of azetukalner in MDD and BPD, Xenon anticipates having sufficient cash to fund operations into 2027. As of June 30, 2025, there were 76,939,811 common shares and 2,173,081 pre-funded warrants outstanding. Research and development expenses for the quarter ended June 30, 2025 were $75.0 million, compared to $49.7 million for the same period in 2024. The increase of $25.3 million was primarily attributable to the ongoing azetukalner Phase 3 clinical trials in epilepsy and MDD, as well as start-up costs for the azetukalner Phase 3 BPD clinical trial, and increased personnel-related costs due to an increase in employee headcount. General and administrative expenses for the quarter ended June 30, 2025 were $19.2 million, compared to $19.4 million for the same period in 2024. Other income for the quarter ended June 30, 2025 was $8.9 million, compared to $10.8 million for the same period in 2024. The decrease of $2.0 million was primarily attributable to lower interest income, partially offset by an increase in foreign exchange gain. Net loss for the quarter ended June 30, 2025 was $84.7 million, compared to $57.9 million for the same period in 2024. The increase in net loss was primarily attributable to higher research and development expenses driven by the azetukalner program, increased personnel-related costs, and lower interest 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 2025 results. A listen-only webcast can be accessed on the Investors section of the Xenon website, with a replay available following the event. Participants can access the conference call by dialing (800) 715-9871 or (646) 307-1963 for international callers and referencing conference ID 4102397. About Azetukalner Phase 3 Epilepsy Program Xenon's Phase 3 epilepsy program includes three Phase 3 clinical trials in focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS). Designed closely after the Phase 2b X-TOLE clinical trial, the Phase 3 X-TOLE clinical trials are multicenter, randomized, double-blind, placebo-controlled studies evaluating the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered orally with food as adjunctive treatment in approximately 360 patients with FOS per study. The primary efficacy endpoint is the median percent change (MPC) in monthly seizure frequency from baseline through the 12-week double-blind period (DBP) of azetukalner compared to placebo. X-ACKT is a multicenter, randomized, double-blind, placebo-controlled study evaluating the clinical efficacy, safety, and tolerability of 25 mg of azetukalner administered with food as adjunctive treatment in approximately 160 patients with PGTCS. The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the 12-week DBP of azetukalner compared to placebo. Upon completion of the DBP in the Phase 3 epilepsy studies, eligible patients may enter an OLE study for up to three years. About Azetukalner Phase 3 MDD X-NOVA Program Xenon's Phase 3 MDD program includes three multicenter, randomized, double-blind, placebo-controlled clinical trials to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 450 patients with moderate-to-severe major depressive disorder (MDD) per study. The primary efficacy endpoint is the change from baseline in the HAM-D17 score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an open-label extension (OLE) study for up to 12 months. About Azetukalner Phase 3 BPD X-CEED Program Xenon's Phase 3 BPD program includes two multicenter, randomized, double-blind, placebo-controlled clinical trials to evaluate the clinical efficacy, safety, and tolerability of 20 mg of azetukalner administered orally with food over the 6-week double-blind period (DBP) as monotherapy treatment in approximately 400 patients per study with bipolar depression (BPD) I or II. The primary efficacy endpoint is the change from baseline in the MADRS score at week 6 in patients who received azetukalner compared to placebo. Upon completion of the DBP, eligible patients may enter an OLE study for up to 12 months. About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (Nasdaq: XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. Xenon's lead molecule, azetukalner, is a novel, potent, selective Kv7 potassium channel opener in Phase 3 clinical trials for the treatment of epilepsy, major depressive disorder (MDD) and bipolar depression (BPD). Xenon is also advancing an early-stage portfolio of multiple promising potassium and sodium channel modulators, including Kv7 and Nav1.7 programs in Phase 1 development for the potential treatment of pain. Xenon has offices in Vancouver, British Columbia, and Boston, Massachusetts. For more information, visit and follow us on LinkedIn and X. 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 in current and anticipated indications, 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 azetukalner and other pipeline and development programs, including the anticipated filing of INDs and NDAs; the timing and results of our interactions with regulators; our ability to successfully develop and obtain regulatory approval of azetukalner and our other product candidates; and anticipated timing of topline data readout from our clinical trials of azetukalner. 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 azetukalner, 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 or completion of clinical trials; the impact of market, industry, and regulatory conditions on clinical trial enrollment; 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 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 U.S. 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. Contacts: For Investors:Chad Fugere Vice President, Investor Relations(857) 675-7275investors@ For Media:Colleen AlabisoSenior Vice President, Corporate Affairs(617) 671-9238media@ XENON PHARMACEUTICALS Consolidated Balance Sheets(Expressed in thousands of U.S. dollars) June 30, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents and marketable securities $ 487,545 $ 626,905 Other current assets 12,707 8,359 Marketable securities, long-term 137,297 127,496 Other long-term assets 36,732 35,379 Total assets $ 674,281 $ 798,139 Liabilities Current liabilities: Accounts payable and accrued liabilities $ 31,588 $ 34,221 Other current liabilities 1,459 1,369 Other long-term liabilities 7,256 7,646 Total liabilities $ 40,303 $ 43,236 Shareholders' equity $ 633,978 $ 754,903 Total liabilities and shareholders' equity $ 674,281 $ 798,139XENON PHARMACEUTICALS Consolidated Statements of Operations and Comprehensive Loss(Expressed in thousands of U.S. dollars except share and per share amounts) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Revenue $ — $ — $ 7,500 $ — Operating expenses: Research and development 74,985 49,702 136,185 93,952 General and administrative 19,244 19,402 38,282 34,193 Total operating expenses 94,229 69,104 174,467 128,145 Loss from operations (94,229 ) (69,104 ) (166,967 ) (128,145 ) Other income 8,897 10,847 17,015 22,369 Loss before income taxes (85,332 ) (58,257 ) (149,952 ) (105,776 ) Income tax recovery (expense) 626 333 199 (79 ) Net loss $ (84,706 ) $ (57,924 ) $ (149,753 ) $ (105,855 ) Other comprehensive income (loss): Unrealized gain (loss) on available-for-sale securities 949 (443 ) 1,725 (2,135 ) Comprehensive loss $ (83,757 ) $ (58,367 ) $ (148,028 ) $ (107,990 ) Net loss per common share: Basic and diluted $ 1.07 $ (0.75 ) $ 1.90 $ (1.36 ) Weighted average common shares outstanding: Basic and diluted 78,953,445 77,671,128 78,820,474 77,632,864 Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
03-07-2025
- Business
- Yahoo
RBC Raises Xenon Price Target, Cites Phase III Optimism for Epilepsy Drug
Xenon Pharmaceuticals Inc. (NASDAQ:XENE) ranks among the 30 stocks expected to beat the market by 20 percentage points this year. RBC Capital maintained its Outperform rating on Xenon Pharmaceuticals Inc. (NASDAQ:XENE) and increased its price target from $55 to $57 on June 13. The change comes after the company examined the translatability of previous Phase II to Phase III medications for epilepsy. The bank's study showed a strong association between the efficacy results of Phase II and Phase III drugs for focal onset seizures, particularly in terms of responder rates and seizure reductions. According to the findings, Xenon's top medication candidate, azetukalner, will likely exhibit similarly encouraging outcomes in its Phase III data, which is expected to be released early next year. Azetukalner's novel Kv7 mechanism of action, quick onset, and possible mood improvements are cited by RBC Capital as competitive advantages in a market dominated by polypharmacy, with the firm suggesting that future sales might reach $1.2 billion. Xenon Pharmaceuticals Inc. (NASDAQ:XENE) is a biopharmaceutical company that specializes in creating therapies for mental and neurological conditions, such as major depressive disorder (MDD) and epilepsy. While we acknowledge the potential of XENE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. Read More: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
