Neuphoria Therapeutics Inc. · NASDAQ:NEUP
Neuphoria Therapeutics — Bionomics — H.C. Wainwright BIOCONNECT Virtual Conference 2022
37 slides from Neuphoria Therapeutics's conference presentation, Jan 12, 2022
Slide 1: Corporate Presentation
Exhibit 99.1 TO IMPROVE THE LIVES OF PATIENTS WITH SERIOUS CNS DISORDERS Corporate Presentation Nasdaq: BNOX ASX: BNO H.C. Wainwright BIOCONNECT Virtual Conference January 10 - 13, 2022
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT 2 Factors Affecting Future Performance This presentation may contain forward-looking statements within the meaning of the United States’ Private Securities Litigation Reform Act of 1995. Any statements contained in this presentation that relate to prospective events or developm
Slide 3: Emerging Leader in Neuropsychiatry
Emerging Leader in Neuropsychiatry 3 Diversified, clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious Central Nervous System (CNS) disorders 1 BNC210 in ongoing Phase 2 for acute treatment in
Slide 4: Focused CNS Pipeline with Multiple Potential Catalysts on the Horizon
Focused CNS Pipeline with Multiple Potential Catalysts on the Horizon 4 ` PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 EXPECTED TIMING Post-Traumatic Stress Disorder (PTSD) Study underway 200 patients across ~25 centers in US Study Topline Data: 1H’23 Social Anxiety Disorder (SAD) BNC210 Study underw
Slide 5: A Differentiated Approach: The a7 Nicotinic Acetylcholine Receptor
A Differentiated Approach: The a7 Nicotinic Acetylcholine Receptor 5 Normalizing Effect Utilizing Allosteric Modulation Targeting Distinct CNS Conditions with Neurotransmitter Imbalance 1 2 2+ Ca flow Channel opens: through the 2+ Ca ACh binds to channel when BNC 210 (NAMs) a7 receptor a7 receptors
Slide 6: Harnessing the Power of a Novel Neuromodulatory Mechanism
Harnessing the Power of a Novel Neuromodulatory Mechanism 6 ANXIETY & NORMAL Action of BNC210 PTSD depends on Acetylcholine neurotransmission NORMAL BNC210 RESTORES and Allosteric ACh MOOD NORMAL MOOD 2+ Ca Modulation of BNC210 MOOD DISORDERS a7 nAChR NAMs have self-limiting activity determined by t
Slide 7: BNC210 in Social Anxiety Disorder
7 BNC210 in Social Anxiety Disorder
Slide 8: Targeting a Large Segment of the Anxiety Market
Targeting a Large Segment of the Anxiety Market 8 Acute Anxiety in SAD Represents a Significant Unmet Need Social Anxiety Disorder (SAD), or Social Phobia, is a significant and persistent fear of social and ~31M performance-related situations 12.1% of adults at some point Includes anxiety from every
Slide 9: BNC210 Significantly Reduced Panic Symptoms in Humans: CCK-4-Induced Model
BNC210 Significantly Reduced Panic Symptoms in Humans: CCK-4-Induced Model 9 Total # of Panic Symptoms Panic Symptom Intensity 100 100 90 90 -37.7% -52.7% Placebo- 80 80 (p<0.048) (p<0.041) 70 70 controlled study 60 60 50 50 in 15 healthy 40 40 30 volunteers who 30 20 20 experienced a 10 10 0 0 CCK-
Slide 10: BNC210 Phase 1b in GAD Observed to Have Acute Anxiolytic Activity
BNC210 Phase 2 in GAD Observed to Have Acute Anxiolytic Activity 10 Performed BNC210 300 mg Fearful ‘JORT’ Faces BNC210 2000 mg Lorazepam 1.5 mg 24 GAD Patients Placebo fMRI Monitoring Significantly reduced activation of Significantly reduced connectivity Significantly reduced threat avoidance L & R
Slide 11: BNC210 Addresses the Shortcomings of Existing Social Anxiety Disorder Approaches
BNC210 Addresses the Shortcomings of Existing Social Anxiety Disorder Approaches 11 CURRENT TREATMENTS FOR SOCIAL ANXIETY DISORDER Large Market NO NO NO FAST NO WITHDRAWAL MEMORY MOTOR Potential for Social DRUG ACTING SEDATION SYNDROME IMPAIRMENT IMPAIRMENT Anxiety Disorder 1 Benzodiazepines X X X X
Slide 12: BNC210's Rapid Onset of Action is Well-Positioned for Social Anxiety Disorder
BNC210’s Rapid Onset of Action is Well-Positioned for Social Anxiety Disorder 12 Emerging Regulatory Landscape & Unmet Need Rapid Onset of Action with BNC210 Formulation ✓✓ • Clinically demonstrated potential for reducing anxiety in acute • No fast-acting FDA-approved medications for treatment of GA
Slide 13: BNC210 Phase 2 PREVAIL Social Anxiety Disorder Trial
BNC210 Phase 2 PREVAIL Social Anxiety Disorder Trial 13 Acute Social Anxiety Disorder Study Highlights Phase 2 PREVAIL Study Design SCREENING LIEBOWITZ SOCIAL ANXIETY SCALE ✓ Potential to conduct a cost-effective trial with LSAS ≥ 70 >95: Very severe social phobia an efficacy endpoint conducive to r
Slide 14: BNC210 in Post-Traumatic Stress Disorder
14 BNC210 in Post-Traumatic Stress Disorder
Slide 15: Tackling the Profound Disease Burden of Post-Traumatic Stress Disorder
Tackling the Profound Disease Burden of Post-Traumatic Stress Disorder 15 PTSD Represents a Significant Unmet Need ✓ 70% of people will experience a traumatic event in their lifetime, but most people recover normally ~21M 8% of adults at ✓ PTSD results from exposure to actual or threatened some poin
Slide 16: BNC210 Anti-Anxiety Signals Observed in Animal Models and Human Translational Studies
BNC210 Anti-Anxiety Signals Observed in Animal Models and Human Translational Studies 16 Conditioned Fear Extinction Model Emotional Visual Analog Scale (eVAS) People with anxiety disorders and PTSD have amplified fear responses to trauma- or stress-related stimuli and impaired fear BNC210 enhanced
Slide 17: BNC210 is Potentially Well-Positioned in Post-Traumatic Stress Disorder
BNC210 is Potentially Well-Positioned in Post-Traumatic Stress Disorder 17 Study ✓ Anti-depressant and ✓ Pharmacometric ✓ New tablet formulation ✓ Type C meeting with ✓ Phase 2b ATTUNE trial anti-anxiety trends seen analysis of Phase 2 overcomes food effect FDA started in July 2021 at earlier time p
Slide 18: Pharmacometric Modeling Target Achieved with New Dose Solid Formulation
Pharmacometric Modeling Target Achieved with New Dose Solid Formulation 18 Pharmacometric (PMX) Analysis Target Exposure BNC210 Novel Spray Dry Dispersion Formulation 0 PMX modelling 300 mg Solid Dose Tablet EXPOSURE- RESPONSE CURVE on prior Phase 2 (BASELINE CAPS-5 -2 PTSD trial identified TOTAL SC
Slide 19: BNC210 Phase 2b PTSD ATTUNE Study Underway
BNC210 Phase 2b PTSD ATTUNE Study Underway 19 WEEK 1 2 3 4 5 6 7 8 9 10 11 12 15 PHASE 2b OUTPATIENT BID DOSING FOLLOW-UP Single potential registrational- supporting trial for monotherapy Phase 2b treatment in PTSD 1:1 RANDOMIZED BNC 210 900 mg oral tablet DOUBLE-BLIND PLACEBO-CONTROLLED PLACEBO KEY
Slide 20: CNS-focused Collaborations
20 CNS-focused Collaborations
Slide 21: Ongoing Strategic Collaboration with Merck & Co.
Ongoing Strategic Collaboration with Merck & Co. 21 • Entered into in 2014 to develop α7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions MSD • Merck funds all R&D activities including clinical development and WW commercial
Slide 22: MOU for BNC210 and MDMA Derivative (EMP-01) for PTSD
22 MOU for BNC210 and MDMA Derivative (EMP-01) for Post-Traumatic Stress Disorder Joint Feasibility Assessment with: • Memorandum of Understanding (MoU) with EmpathBio Inc (EmpathBio) • To collectively explore a combination drug treatment regimen with BNC210 and EMP-01 22 February 2021 Illustrative
Slide 23: Investment Highlights & Stock and Financial Information
23 Investment Highlights & Stock and Financial Information
Slide 24: Stock and Financial Snapshot
1 Stock and Financial Snapshot 24 • Cash: US$40.4M / A$53.9M • Debt: $0 • Shares Outstanding: ~1,310M (NASDAQ:BNOX | ASX:BNO) • Warrants Outstanding: 142M (WAEP = US$0.04 / A$0.06) • Significant Investors: ▪ Biotechnology Value Fund ▪ Apeiron Investment Group Ltd. ▪ Merck & Co Figures as of Septembe
Slide 25: Bionomics Outlook: Renewed Value-driving Trajectory
Bionomics Outlook: Renewed Value-driving Trajectory 25 Diversified model with multiple value-driving clinical milestones expected in the next 4 – 6 quarters BNC210’s novel rapid onset formulation granted Fast Track designation for acute treatment of SAD 1 Established clinical proof-of-concept ; expe
Slide 26: APPENDIX: Management Team & Board of Directors
26 APPENDIX: Management Team & Board of Directors
Slide 27: Powered by a Seasoned and Experienced Management Team
Powered by a Seasoned and Experienced Management Team 27 1 BOARD OF DIRECTORS Connor Bernstein Errol De Souza, PhD Errol De Souza PhD VP Strategy & Corporate Executive Chairman Executive Chairman Development David Wilson Non-Executive Director Adrian Hinton Alan Fisher Liz Doolin Non-Executive Direc
Slide 28: APPENDIX: BNC210 Prior Clinical Trial Information
28 APPENDIX: BNC210 Prior Clinical Trial Information
Slide 29: Summary of BNC210 Clinical Trials: Excellent Safety and Tolerability Profile
Summary of BNC210 Clinical Trials: Excellent Safety and Tolerability Profile in 29 Healthy Subjects and Patients Participants / Subjects Enrolled / Phase Description BNC210 Formulation and Doses Location Setting Administered BNC210* 1 Single Ascending Dose Safety and PK Healthy volunteers / In-clini
Slide 30: Mechanistic Validation of BNC210 as Evidenced by EEG Response
Mechanistic Validation of BNC210 as Evidenced by EEG Response 30 BNC210 Reduced Nicotine-induced EEG Responses Activation of nicotinic receptors in the brain induces EEG response BNC210 blood-brain α4β2 and α7 receptors are the major nAChR populations targeted barrier penetration and nicotinic recep
Slide 31: Phase 2 Trial of BNC210 in Adults with PTSD
Phase 2 Trial of BNC210 in Adults with Post-Traumatic Stress Disorder (PTSD) 31 • Multi-center, randomized, double-blind, placebo-controlled • BNC210 150 mg, 300 mg, 600 mg and placebo (1:1:1:1) (liquid suspension formulation taken twice daily, b.i.d.) Study Design • 12-week treatment period • 193 p
Slide 32: BNC210 PTSD Trial Overall Conclusions
BNC210 PTSD Trial Overall Conclusions 32 No overall effect on primary endpoint of CAPS-5 total severity score at 12 weeks Australian patients had a greater improvement over placebo than US patients ✓CAPS-5 statistically significant at Week 4 in Australians (p<0.05) Evidence of antidepressant effect
Slide 33: Emerging CNS Pipeline for Partnering
33 Emerging CNS Pipeline for Partnering
Slide 34: Kv3.1 / Kv3.2 Ion Channel Activators for Cognitive Dysfunction and Negative Symptoms
Kv3.1 / Kv3.2 Ion Channel Activators for Cognitive Dysfunction and Negative Symptoms 34 Promising therapeutic strategy for Potential in schizophrenia, Autism Spectrum disorders improving cognitive disfunction and social and conditions with cognitive impairments withdrawal symptoms Bionomics’ molecul
Slide 35: Pan Nav Inhibitors: Potential Non-Addictive Chronic Pain Therapies
Pan Nav Inhibitors: Potential Non-Addictive, Reduced Side-Effect Chronic Pain Therapies 35 Associated with human pain Gain & Loss-of-function Disease-Related syndromes where extreme mutations in Nav1.7, 1.8 Genetics pain or no pain is experienced and 1.9 1000+ COMPOUNDS Lead Candidate SYNTHESIZED BN
Slide 36: APPENDIX: Building Value Through Legacy Oncology Assets
36 APPENDIX: Building Value Through Legacy Oncology Assets
Slide 37: Legacy Oncology Asset Monetization to Drive Value: BNC101
Legacy Oncology Asset Monetization to Drive Value: BNC101 37 Exclusive BNC101 Oncology License Agreement • Exclusive Agreement to license Bionomics’ BNC101 oncology for the Development of CAR-T Therapeutics drug candidate to Carina Biotech for the development of Chimeric Antigen Receptor T cell (CAR
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