NEUP

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Last patient last visit (LPLV) milestone in AFFIRM-1 Phase 3 trial of BNC-210 in social anxiety disorder (SAD) achieved; topline readout anticipated in early Q4 2025 Cash runway extended through fiscal Q2 2027 BURLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today reported its financial results for its fiscal year ended June 30, 2025, and provided recent business updates. “It is an exciting time for Neuphoria as we rapidly approach topline data from our AFFIRM-1 Phase 3 study of BNC-210 in social anxiety disorder, which is anticipated early in the fourth quarter of this year,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “BNC-210 is supported by a robust body of clinical data, demonstrating clinically meaningful effects across multiple stress and anxiety indications. These data, along with its differentiated safety profile, give us confidence in BNC-210 as a potentially transformative treatment for patients struggling with SAD.” Clinical Program Highlights The LPLV milestone has been achieved in the AFFIRM-1 Phase 3 trial evaluating BNC-210 as a first-in-class, acute, “as needed” treatment for SAD. Topline data are anticipated in early fourth quarter 2025. Start-up activities continue for the SYMPHONY Phase 2b/3 trial in PTSD. Neuphoria plans to initiate the clinical study in the first half of 2026. MK-1167, one of two positive allosteric modulator (PAM) candidates being advanced in a strategic partnership with Merck & Co, Inc., is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease. June 30th Fiscal Year-End 2025 Financial Results and Key Highlights Cash Position: Cash and cash equivalents were $14.2 million as of June 30, 2025. The Company expects its current cash position to be sufficient to fund operations through the second fiscal quarter of 2027. R&D Expenses: Research and development expenses were $9.0 million for the year ended June 30, 2025, compared to $9.4 million for the year ended June 30, 2024. The decrease of $0.4 million was primarily due to the timing of clinical and consulting related spend. G&A Expenses: General and administrative expenses were $7.8 million for the year ended June 30, 2025, compared to $8....

Cash runway into Q3 2026 AFFIRM-1 Phase 3 clinical trial of BNC-210 in social anxiety disorder on track for topline readout in Q3 2025 α7 nicotinic acetylcholine receptor PAM MK-1167 partnered with Merck and in Phase 2 clinical trial in Alzheimer’s BURLINGTON, Mass., May 20, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today provides business updates for the First Quarter of 2025. “The first quarter of 2025 marked steady progress across our pipeline,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “Our lead internal program BNC210 continues to enroll into the AFFIRM-1 Phase 3 study in Social Anxiety Disorder, and we are planning to release topline data in Q3 this year. We’re also very pleased to see our partnered asset, MK-1167, continue its momentum in the Merck-led Phase 2 trial in Alzheimer’s disease.” Recent Highlights Clinical Programs Phase 3 AFFIRM-1 with BNC210 for the acute, as-needed treatment of anxiety in social anxiety disorder (SAD) trial is proceeding with topline results anticipated in Q3 2025. BNC210 has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials in panic attacks, generalized anxiety disorder (GAD) and social anxiety disorder (SAD) without evidence of sedation, impairments in cognition or addiction potential. Planning for a Phase 2b (SYMPHONY) trial for BNC210 in PTSD is underway following a successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA). The proposed SYMPHONY trial is being designed to help identify a second (lower) dose for BNC210 in order to further de-risk the program prior to advancing onto a Phase 3 trial, contingent on meeting capital requirements for the next program milestone (Ph3 AFFIRM-1 SAD trial read-out). FOR FURTHER INFORMATION PLEASE CONTACT: About Neuphoria Therapeutics Inc. Neuphoria (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, “as needed” treatmen...