Neuphoria Therapeutics Provides Update on AFFIRM-1 Phase 3 Trial Evaluating BNC210 for the Acute Treatment of Social Anxiety Disorder

Core Insights - Neuphoria Therapeutics Inc. announced that the AFFIRM-1 Phase 3 trial of BNC210 for social anxiety disorder did not meet its primary or secondary endpoints [1][3] - The company plans to conduct a strategic review of its portfolio and operations to maximize shareholder value [2][3] Trial Results - The AFFIRM-1 trial did not show statistically significant changes in the primary endpoint, which was the change in Subjective Units of Distress Scale (SUDS) scores during a public speaking challenge [1][6] - Secondary endpoints also failed to demonstrate significant differences, although the safety and tolerability profile of BNC210 remained favorable [1][3] Strategic Actions - Following the trial results, Neuphoria will discontinue the development of its social anxiety disorder program [3] - The company will evaluate further development of BNC210 for post-traumatic stress disorder (PTSD) based on previous positive data [3] Financial Position - As of June 30, 2025, Neuphoria had cash and cash equivalents of $14.2 million, which is expected to fund operations through the second fiscal quarter of 2027 [5] Partnerships - Neuphoria has an ongoing partnership with Merck for the development of MK-1167, which is currently in a Phase 2 trial for Alzheimer's disease [4][7] - The partnership with Merck could yield up to $450 million in milestone payments and royalties on net sales of licensed medicines [4]