XENE — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We announced positive topline data from the Phase 3 X-TOLE2 study in March 2026. The study met its primary endpoint of median percent change (MPC) in monthly FOS frequency from baseline to week 12 in both the 25 mg and 15 mg azetukalner dose groups compared to placebo (MPC of -53.2%, -34.5% and -10.…

• X-TOLE2 topline efficacy and safety results were featured as a Late Breaking Science oral and poster presentation at the American Academy of Neurology (AAN) Annual Meeting in Chicago, Illinois, April 18-22. Also at AAN, we presented 48-month data from the ongoing X-TOLE open-label extension study, w…

• The Phase 3 X-TOLE3 study of azetukalner in FOS continues to enroll and is intended to support regulatory submissions outside the United States. X-TOLE3 enrollment outside of Japan is expected to complete in 2026.

• The Phase 3 X-ACKT study of azetukalner in PGTCS continues to enroll and is intended to support regulatory submissions for an additional epilepsy indication.

• Enrollment is ongoing for the Phase 3 X-NOVA2 and X-NOVA3 studies evaluating azetukalner in patients with MDD, with topline data from X-NOVA2 expected in H1 2027.

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• Phase 3 X-TOLE2 study of azetukalner in FOS has completed patient enrollment with 380 patients randomized and topline data anticipated in early 2026.

• Phase 3 X-TOLE3 study of azetukalner in FOS continues patient enrollment.

• Phase 3 X-ACKT study of azetukalner in PGTCS continues to enroll patients and is intended to support regulatory submissions for an additional epilepsy indication.

• X-NOVA2 and X-NOVA3, the first two of three planned Phase 3 clinical studies evaluating azetukalner in patients with MDD, are underway.

• X-CEED, the first of two planned Phase 3 clinical studies evaluating azetukalner in patients with BPD I and BPD II, is underway.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We have no marketed proprietary products and are advancing clinical development through Phase 3 clinical studies for our azetukalner program in epilepsy, major depressive disorder, and bipolar depression. These studies may not result in regulatory approval or successful commercialization of our prod…

• While we are advancing our Phase 3 clinical studies in azetukalner, significant risks remain. There can be no assurance that these or any future clinical studies will be successful, that we will be able to obtain regulatory approval, or that we will be able to manufacture or independently commercial…

• To execute on our business plan for the development of independent programs, we will need to successfully:

• In the U.S., federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, and consumer protection laws. For example, the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HI…

• Additional data privacy and security laws have been proposed and enacted at the federal, state, and local levels in recent years, which could further complicate compliance efforts. For example, in June 2024, the Protecting Americans’ Data from Foreign Adversaries Act of 2024 took effect. This law pr…

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• We have no marketed proprietary products and have not yet completed clinical development beyond Phase 2 clinical studies, which makes it difficult to assess our ability to develop our future product candidates and commercialize any resulting products independently.

• In the U.S., federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, and consumer protection laws. For example, the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HI…

• We currently have no products approved for commercial sale and are investing significant efforts and financial resources in the development of our clinical-stage product candidate, azetukalner for the treatment of epilepsy, MDD, BPD and potentially other neurological disorders. Our future business s…

• acceptance of azetukalner, if and when approved, by patients, the medical community and third-party payers;

• In addition, prescription drugs may be promoted only for the approved indications in accordance with the approved label. The FDA, EMA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• During our last fiscal quarter, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K.

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• On August 15, 2025, Dr. Gillian Cannon, a member of the Board of Directors, adopted a trading plan intended to satisfy the requirements of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended. The plan provides that commencing June 5, 2026, Dr. Cannon will sell 45% of the gross share…

• On August 17, 2025, Dr. Gary Patou, a member of the Board of Directors, adopted a trading plan intended to satisfy the requirements of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended. The plan provides that commencing June 5, 2026, Dr. Patou will sell 50% of the gross shares iss…