Neuphoria Releases Review Of 2024 And Highlights 2025 Plans Including $15M Payment From Merck Extending Company's Cash Runway To Q3 2026 And Phase 3 Affirm-1 Trial of BNC210 In Social Anxiety Disorder Progressing As Planned With Topline Readout Anticipated In Q3 2025

• Initiation by Merck of a Phase 2 trial in Alzheimer's disease with partnered α7 nicotinic acetylcholine receptor PAM MK-1167 highlights company's pipeline diversification beyond BNC210
• US $15M milestone payment from Merck extends company's cash runway to Q3 2026
• Phase 3 AFFIRM-1 trial of BNC210 in social anxiety disorder (SAD) is progressing as planned with topline readout anticipated in Q3 2025
• A Phase 2b dose ranging study with a lower dose of BNC210 in post-traumatic stress disorder (PTSD) is planned to follow the read-out of the Phase 3 study in social anxiety disorder SAD.

BURLINGTON, Mass., April 15, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (NASDAQ:NEUP) ("Neuphoria" or the "Company"), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today provided a review of 2024 and highlighted plans for 2025.

"2024 and the first quarter of 2025 were transformational for our pipeline; Our internal BNC210 program entered Ph3 in Social Anxiety Disorder with robust enrollment, and our partnered α7 nicotinic acetylcholine receptor positive allosteric modulator (PAM) program with Merck for the treatment of the symptoms of Alzheimer's disease dementia advanced to Phase 2," said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. "We are now beginning a promising 2025 as we look to deploy our resources on programs that have the highest chance of providing the greatest benefit to patients and generating the greatest value to shareholders."

Recent Highlights and 2025 Plans

Clinical Programs

• Initiated the Phase 3 AFFIRM-1 trial with 225mg BNC210 for the acute, as-needed treatment of anxiety in social anxiety disorder (SAD) in July 2024.
  • The Phase 3 AFFIRM-1 trial is progressing as planned with enrollment being on-track for topline results anticipated in Q3 2025.
  • Agreement with the U.S. Food and Drug Administration (FDA) on the design of BNC210's registrational program in social anxiety disorder (SAD) has been reached during an End-of-Phase 2 (EoP2) held in Q3 2023.
  • 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.
• Held a successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA) in July 2024, providing a potential registrational path for BNC210 in PTSD.
  • A Phase 2b trial of BNC210 in PTSD is being planned to help identify a second (lower) dose for BNC210 further de-risking the program before progressing to Phase III while reducing short- and mid-term capital requirements to the next program milestone.
  • Based on extensive pharmacokinetic and pharmacodynamic analysis of existing datasets, BNC210 450 mg BID (lower dose) is expected to provide clinically meaningful efficacy similar to that observed with 900mg BID in the ATTUNE Phase 2b trial while improving the overall safety and tolerability profile.
  • The Phase 2b study in PTSD is scheduled to begin in Q4 2025, following the release of topline results from the ongoing Phase 3 AFFIRM-1 trial in social anxiety disorder (SAD).
• Published the clinically meaningful improvements seen with BNC210 across several key PTSD symptoms in NEJM Evidence in December 2024 (https://doi.org/10.1056/evidoa2400380).
• The results of the Phase 3-enabling PREVAIL Phase 2 study of BNC210 in social anxiety disorder (SAD) published in Psychiatry Research, in February 2025 (https://doi.org/10.1016/j.psychres.2025.116387).
• Initiation by Merck (known as MSD outside the United States and Canada) of a Phase 2 clinical trial to evaluate the safety and efficacy of MK-1167, a partnered α7 nicotinic acetylcholine receptor positive allosteric modulator (PAM) program, for the treatment of the symptoms of Alzheimer's disease dementia (NCT06721156).