Bionomics Provides a Review of 2023 and of 2024 Plans

Positive Phase 2b data announced for BNC210 on reduction of total symptom severity and multiple symptom clusters in post-traumatic stress disorder (PTSD), with a discussion with the U.S. Food & Drug Administration (FDA) anticipated in Q2’24.

Positive End of Phase 2b (EoP2) meeting with FDA announced for BNC210 in Social Anxiety Disorder (SAD) following the Phase 3-enabling PREVAIL Phase 2 trial data readout.

The Company is actively engaged in strategic partnership discussions with interested parties for multiple pipeline assets and is evaluating options to proceed with clinical development plans for BNC210 in both PTSD and SAD.

ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today provided a 2023 review and its outlook for 2024.

“Bionomics continued its evolution into a U.S.-focused, late-stage clinical company last year. We finished 2023 with strong momentum from our positive readout in Phase 2b ATTUNE trial in PTSD and the successful EoP2 meeting with the FDA, paving the path to a registrational study in SAD. These two BNC210 programs generated significant interest from potential strategic partners, including the opportunity to co-develop and commercialize BNC210 in PTSD and SAD in the U.S. and abroad. We will explore such potential opportunities in parallel with other pathways that provide near and long-term value to the Company and its shareholders. Additionally, we’ve been receiving interest in our promising preclinical assets, KV3.1/3.2 channel activators and Pan Nav inhibitors, where we have identified lead candidates and continued our work on the 2^nd generation α7 nicotinic receptor negative allosteric modulator (NAM) lead series,” commented Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics.

2023 Highlights

Key Clinical Highlights

BNC210 in Social Anxiety Disorder and Post-Traumatic Stress Disorder
A first and best-in-class α7 nicotinic, Phase 3-ready NAM of the α7 nicotinic receptor with a unique and differentiated psychoactive profile suitable for acute and chronic dosing in multiple CNS indications:

Post-Traumatic Stress Disorder

• Positive topline results from the Phase 2b ATTUNE study were announced in September 2023, meeting the primary endpoint on reduction in total symptom severity and highlighting the potential of BNC210 to improve multiple PTSD symptom clusters with notable effects on thought intrusions, mood, trauma-related cognition, and sleep. The BNC210 program is the only non-psychedelic program with a novel mechanism of action to advance in late-stage development in recent years.