Bionomics Investor Presentation Deck

Made public by

sourced by PitchSend

1 of 41

Creator

Bionomics logo
Bionomics

Category

Healthcare

Published

April 2022

Slides

Transcriptions

#1TO IMPROVE THE LIVES OF PATIENTS WITH SERIOUS CNS DISORDERS Corporate Presentation ASX: BNO Nasdaq: BNOX April 2022 Bionomics#2SAFE HARBOR STATEMENT 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 developments, including, without limitation, statements made regarding Bionomics' drug candidates (including BNC210, BNC105, BNC101 and BNC375), its licensing agreement with Merck & Co. and any milestone or royalty payments thereunder, drug discovery programs, ongoing and future clinical trials, and timing of the receipt of clinical data for our drug candidates are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions are intended to identify forward-looking statements. 2 There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements, including unexpected safety or efficacy data, unexpected side effects observed in clinical trials, risks related to our available funds or existing arrangements, delays or difficulties associated with conducting clinical trials, our failure to introduce new drug candidates or platform technologies or obtain regulatory approvals in a timely manner or at all, regulatory changes, inability to protect our intellectual property, risks related to our international operations, as well as other factors. Results of studies performed on our drug candidates and competitors' drugs and drug candidates may vary from those reported when tested in different settings. The inclusion of forward-looking statements should not be regarded as a representation by Bionomics that any of its expectations, projections or plans will be achieved. Actual results may differ from those expectations, projections or plans due to the risks and uncertainties inherent in Bionomics business and other risks described in Bionomics' filings with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation. Subject to the requirements of any applicable legislation or the listing rules of any stock exchange on which our securities are quoted, we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation. Certain information contained in this presentation relates to, or is based on, studies, publications, surveys and other data obtained from third party sources and Bionomics' own internal estimates and research. While we believe these third party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. Bionomics#3Emerging Leader in Neuropsychiatry Bionomics Bionomics 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 H BNC210 in Phase 2 for acute treatment in Social Anxiety Disorder (SAD) – Established clinical PoC in GAD¹ and Fast Track designation from FDA for SAD BNC210 in ongoing Phase 2b ATTUNE trial with Fast Track designation from FDA for PTSD Large underserved markets with over 22 million patients in the United States alone suffering from SAD and PTSD and no new FDA approved therapies in nearly two decades Strategic partnership with Merck & Co. for cognitive impairment in Alzheimer's disease and other CNS conditions Pipeline of partnering candidates targeting potassium (Kv) and sodium (Nav) ion channels 3 Well-capitalized balance sheet with multiple potential near term value-driving milestones PoC = Proof of Concept GAD = Generalized Anxiety Disorder PTSD = Post-Traumatic Stress Disorder 1. Wise et al 2020, Biological Psychiatry; Perkins et al 2021, Molecular Psychiatry#4E Focused CNS Pipeline with Multiple Potential Catalysts on the Horizon PROGRAM BNC210 a7 receptor NAM EmpathBio MERCK COLLABORATION a7 receptor PAM PAIN Nav1.7/1.8 Inhibitors COGNITION Kv3.1/3.2 Activators Bionomics PRECLINICAL Social Anxiety Disorder (SAD) 150 patients across 15-20 centers in US Post-Traumatic Stress Disorder (PTSD) 200 patients across ~25 centers in US +MDMA derivative EMP-01 (PTSD) 2 candidates for cognitive deficits in Alzheimer's disease Candidate PHASE 1 Series Lead NAM = Negative Allosteric Modulator PAM = Positive Allosteric Modulator PHASE 2 PREVAIL Study ATTUNE Study Memorandum of Understanding to explore combination treatment regimen for PTSD Fast Track Designation Fast Track Designation PHASE 3 EXPECTED TIMING Study underway Topline Data: YE'22 Study underway Topline Data: 1H'23 Ongoing Phase 1 safety & biomarker studies ongoing Ongoing 4#5A Differentiated Approach: The a7 Nicotinic Acetylcholine Receptor 3 Normalizing Effect Utilizing Allosteric Modulation 2 1 Channel opens: ACh binds to a7 receptor orthosteric sites PAMS/NAMS bind to a7 receptor allosteric sites Bionomics Ca²+ = Calcium ions ACh = Acetylcholine Ca2+ Ca²+ NAM = Negative Allosteric Modulator PAM = Positive Allosteric Modulator 4 CIAS = Cognitive Impairment Associated with Schizophrenia ADHD=Attention Deficit Hyperactivity Disorder Ca²+ flow through the channel when a7 receptors are activated ooooo {}}{ Transmembrane Binding Domain 0000000 Allosteric drug transmembrane binding domain restores normal activity Cholinergic System associated with memory, selective attention, and emotional processing cognitive functions PTSD = Post-Traumatic Stress Disorder Hypercholinergic Disease States Targeting Distinct CNS Conditions with Neurotransmitter Imbalance PAM Indications Bionomics NORMAL ACTIVITY + Alzheimer's + CIAS + ADHD BNC 210 (NAMS) + Anxiety + PTSD + Depression LO Hypocholinergic Disease States 5#6Harnessing the Power of a Novel Neuromodulatory Mechanism Action of BNC210 depends on Acetylcholine neurotransmission and Allosteric Modulation of a7 nACHR Bionomics FP nAChR = Nicotinic Acetylcholine Receptor NAM = Negative Allosteric Modulator Ca²+ = Calcium ions AChAcetylcholine ACh Ca²+ BNC210 Hippocampus Prefrontal Cortex Basal Forebrain Amygdala NORMAL Ca2+ NORMAL MOOD a7nACh Receptor Ca2+ INFLUX Hippocampus Prefrontat Cortex Basal Forebrain Amygdala ANXIETY & PTSD MOOD DISORDERS + BNC210 Ca2+ INFLUX Ca2+ Ca2+ INFLUX BNC210 RESTORES NORMAL MOOD NAMs have self-limiting activity determined by the cooperative interaction between BNC210 and Acetylcholine binding at the allosteric and orthosteric sites, respectively 6#7BNC210 in Social Anxiety Disorder A Bionomics 7#8Acute Anxiety in SAD Represents a Significant Unmet Need Social Anxiety Disorder (SAD), or Social Phobia, is a significant and persistent fear of social and performance-related situations iso ● Targeting a Large Segment of the Anxiety Market ● ● Includes anxiety from everyday social situations as well as "Fear of Public Speaking" A disorder that substantially impacts many people's daily lives Amongst the largest mental health conditions with lifetime prevalence affecting >31M Americans No FDA-approved fast-acting medications for as-needed treatment Bionomics Medications with the right pharmacokinetic profile and a novel mechanism are needed ~31M 12.1% of adults at some point in their lives ~18M 7.1% prevalence in adults Unmet medical need to large patient population Advancement in care No FDA-approved fast-acting competition Ability to potentially achieve large market share Sources: US Census Bureau. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html NIMH. 'Social Anxiety Disorder' data from 2017 National Comorbidity Survey (NCS). https://www.nimh.nih.gov/health/statistics/social-anxiety-disorder.shtml Anxiety and Depression Association of America (ADAA). 'Social Anxiety Disorder - Understand the Facts' https://adaa.org/understanding-anxiety/social-anxiety-disorder ~7M 36% of adults > 10 years SAD symptoms Opportunity for BNC210 8#9BNC210 Significantly Reduced Panic Symptoms in Humans: CCK-4-Induced Model Placebo- controlled study in 15 healthy volunteers who experienced a CCK-4-induced panic attack Bionomics Panic Symptom Scale (% of Placebo) 100 90 80 70 60 40 30 20 10 0 Total # of Panic Symptoms -37.7% (p<0.048) CCK-4 = Cholecystokinin Tetrapeptide (a peptide that induces anxiety and panic symptoms) Panic Symptom Scale (% of Placebo) Placebo 100 90 80 70 60 50 40 30 20 10 0 Panic Symptom Intensity BNC210 -52.7% (p<0.041) BNC210 demonstrated reduction in panic symptoms and intensity as measured with the Panic Symptom Scale 9#10300 mg BNC210 Demonstrated Acute Anxiolytic Activity in GAD Phase 2 Fearful Faces 24 GAD Patients 4 WAY CROSSOVER Significantly reduced activation of L & R amygdala caused by viewing fearful faces (L: p<0.05; R: p<0.01) Bionomics BNC210 300 mg BNC210 2000 mg Lorazepam 1.5 mg Placebo Contrast estimate Significantly reduced connectivity between amygdala and ACC while viewing fearful faces (p<0.05) 1.0 0.8 0.6 0.4 0.2 0.0 -0.2 Placebo Seed hemisphere Left Right fMRI Monitoring 300 mg 0.5 0.4- 0.3- 0.2 Significantly reduced threat avoidance behavior of anxious subjects in the JORT behavioral task Mean Intensity of Defensive Behavior 0.1- 0.0 Performed 'JORT' Placebo P=0.165 Lorazepam P=0.007 300 mg Error Bars SEM = BNC210 Wise T. et al., Biological Psychiatry 2020 (https://doi.org/10.1016/j.biopsych.2019.12.013); Perkins A. et al., Translational Psychiatry 2021 (https://doi.org/10.1038/s41398-020-01141-5) GAD = Generalized Anxiety Disorder JORT=Joystick Operated Runway Task fMRI = Functional Magnetic Resonance Imaging Amygdala activation is an imaging surrogate for anxiety Connectivity between the amygdala and Anterior Cingulate Cortex (ACC) is very strong in high anxiety P=0.033 2000 mg 10#11BNC210 Addresses the Shortcomings of Existing Social Anxiety Disorder Approaches Novel Mechanism of Action Bionomics Attractive Clinical & Regulatory Pathway Anti-Anxiety Effects BNC 210 Potential for Acute Treatment in Social Anxiety Disorder Patients 1. 2. Rapid Onset of Action Unique Formulation Attributes CURRENT TREATMENTS FOR SOCIAL ANXIETY DISORDER NO NO NO WITHDRAWAL MEMORY MOTOR SYNDROME IMPAIRMENT IMPAIRMENT X X X DRUG Benzodiazepines 2 DRUG FAST ACTING ✔ SSRIs/SNRIS X ✔ X ✔ BNC210 BNC210 IS DESIGNED TO PROVIDE ADVANTAGES COMPARED TO CURRENT THERAPIES* NO SEDATION X FAST ACTING ✔ NO SEDATION ✔ * Potential benefits based on analysis of data from separate studies and not on results that might have been obtained from head-to-head studies. Such data may not be directly comparable due to differences in study protocols, conditions and patient populations. Accordingly, cross-trial comparisons may not be reliable predictors of the relative efficacy or other benefits of BNC210 compared to existing therapies or other product candidates that may be approved or are in development for the treatment of PTSD or SAD. Includes Valium and certain other benzodiazepines Includes Prozac and certain other SSRIs (Selective Serotonin Reuptake Inhibitors) /SNRIS (Serotonin-Norepinephrine Reuptake Inhibitors) ✔ NO NO NO WITHDRAWAL MEMORY MOTOR SYNDROME IMPAIRMENT IMPAIRMENT E ✔ ✔ 11#12✓ Emerging Regulatory Landscape & Unmet Need Benzodiazepines prescribed off-label have significant side effects of sedation, cognitive impairment and potential for addiction ● ● BNC210's Rapid Onset of Action is Well-Positioned for Social Anxiety Disorder ● Growing unmet need based on improving awareness and evolving regulatory dynamics FDA precedent on simplified public speaking challenge endpoint for acute anxiety reduction vs. placebo* Bionomics *Based on path of CNS peer proceeding with registrational Phase 3 endpoint ● ● ● ✓ Rapid Onset of Action with BNC210 Formulation Clinically demonstrated potential for reducing anxiety in acute treatment of GAD patients and following panic induction Observed acute anxiolytic efficacy of BNC210 similar to lorazepam without sedative properties and addiction liability Formulation well-suited for acute dosing - Rapidly absorbed to high concentrations within a short period of time 路 Maximum concentrations reached in -45-105 min. across the dose range Concentration ng/ml 6000- 5000- 4000- 3000- 2000- 1000- 0 2 T 4 6 Concentration versus Time 1200 mg tablet fasted 900 mg tablet fasted 8 10 12 14 Time (hours) 600 mg tablet fasted 300 mg tablet fasted 16 12 18 20 22 24#13BNC210 Phase 2 PREVAIL Social Anxiety Disorder Trial Acute Social Anxiety Disorder Study Highlights ✓ Cost-effective trial with an efficacy endpoint conducive to rapid data generation ✓ Ability to leverage VistaGen's development plan and trial design for Social Anxiety Disorder Received FDA clearance for IND filing and FDA Fast Track designation ✓ Phase 2 trial underway and will read out topline data by end of 2022 Bionomics LSAS = Liebowitz Social Anxiety Scale Phase 2 PREVAIL Study Design -50 225 mg BNC 210 60min SCREENING LSAS ≥ 70 RANDOMIZATION (DOUBLE-BLIND) -50 675 mg BNC 210 60min SINGLE ANXIETY CHALLENGE 台 frases -50 PLACEBO X 60min FDA Fast Track designation PREVAIL Study 13 LIEBOWITZ SOCIAL ANXIETY SCALE >95: Very severe social phobia 80-95: Severe social phobia 65-80: Marked social phobia 55-65: Moderate social phobia 15-20 CENTERS EFFICACY ENDPOINT SUBJECTIVE UNITS OF DISTRESS SCALE (SUDS): Measures the self-reported intensity of anxiety and/or distress in SAD patients Topline data YE'22#14BNC210 in Post-Traumatic Stress Disorder I Bionomics 14#15Tackling the Profound Disease Burden of Post-Traumatic Stress Disorder PTSD Represents a Significant Unmet Need ✓ 70% of people will experience a traumatic event in their lifetime, but most people recover normally ✓ PTSD results from exposure to actual or threatened death, serious injury or sexual violence ✓ Affects up to 8% of adults during their lifetime¹ ✓ PTSD is a global mental health problem that is associated with significant morbidity and mortality and shows up in all facets of peoples' lives ✓ No newly approved pharmacotherapy in almost two decades ✓ Medications with a novel mechanism of action that can address the pathophysiology of PTSD are needed Bionomics ~21M 1. 8% of adults at some point in their lives ~9M 3.4% prevalence in adults Unmet medical need to large patient population Advancement in care No branded competition Ability to potentially achieve large market share Kilpatrick, D., Resnick, H., Milanak, M., Miller, M., Keyes, K. and Friedman, M., 2013. National Estimates of Exposure to Traumatic Events and PTSD Prevalence Using DSM-IV and DSM-5 Criteria. Journal of Traumatic Stress, 26(5), pp.537-547; 2 Mayo LM, Asratain A., Lindé J et al. Elevated Anandamide, Enhanced Recall of Fear Extinction, and Attenuated Stress Responses Following Inhibition of Fatty Acid Amide Hydrolase: A Randomized, Controlled Experimental Medicine Trial. Biol Psychiatry. 2020 Mar 15; 87(6): 538-54 2. Only 20 to 30% of PTSD patients achieve clinical remission on SSRI therapies. US Census Bureau. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html ~7M 75% of adults inadequately treated ² Opportunity for BNC210 15#16BNC210 Anti-Anxiety Signals Observed in Animal Models and Human Translational Studies People with anxiety disorders and PTSD have amplified fear responses to trauma- or stress-related stimuli and impaired fear extinction Bionomics Time Spent Freezing (sec) Conditioned Fear Extinction Model 175 150- 125 100 75 50 25 0 1 T 2 * 3 4 Days after Conditioning Diazepam (0.5 mg/kg) Vehicle BNC210 (100 mg/kg) P = 0.03 p = 0.01 *Time in minutes after CCK-4 injection CCK-4 = Cholecystokinin Tetrapeptide (a peptide that induces anxiety and panic symptoms) eVAS Emotional Visual Analog Scale 5 6 BNC210 enhanced fear extinction following conditioned response training eVAS Score Emotional Visual Analog Scale (eVAS) 10 -10 -20 -30 Recovery to Baseline BNC 210 5 10 15 20 60 Placebo Recovery to Baseline 5 10 15 20 60 Minutes (Post-Panic Attack)* BNC210 enhanced emotional recovery following a CCK-induced panic attack 16#17BNC210 is Well-Positioned in Post-Traumatic Stress Disorder restore ++++ ✓ Anti-depressant and anti-anxiety trends seen at earlier time points ✓ Safety profile generally well tolerated Did not meet primary endpoint*; lower than expected exposure of liquid suspension formulation Bionomics BU Pharmacometric analysis of Phase 2 PTSD data ✓ Predicted significant efficacy potential with adequate drug exposure achieved *Primary endpoint of CAPS-5 total symptom severity score at 12 weeks HE neee Ue e e New tablet formulation overcomes food effect of suspension formulation Achieved exposure target predicted from pharmacometric analysis ✓ Extended IP coverage FDA 晶 Type C meeting with FDA ✓ FDA granted Fast Track designation in PTSD ATTUNE Study Phase 2b ATTUNE trial started in July 2021 ✓ Topline data expected 1H 2023 17#18PMX modelling on prior Phase 2 PTSD trial identified liquid suspension under-exposure ne e ee O Pharmacometric Modeling Target Achieved with New Dose Solid Formulation e BNC210 tablet formulation New formulation achieves target AUC >25 mg.hr/L with 900 mg dose b.i.d. Bionomics Pharmacometric (PMX) Analysis Target Exposure RESPONSE (A from Placebo) 0 -8 0 10 20 EXPOSURE-RESPONSE CURVE (BASELINE CAPS-5 TOTAL SCORE OF 30) 30 40 EXPOSURE: AUC (mg.hr/L) AUC Values (plasma exposure) AUC 90 25 mg.hr/L = 7-Day Pharmacokinetic study of BNC2 10 tablet formulation mean AUC (mg.hr/L) ± standard deviation PMX= Population pharmacometric modelling b.id=Administered twice daily 50 7-Day PK Trial New tablet formulation In-clinic setting CAPS-5 Score (PTSD symptoms) 60 BNC210 Novel Spray Dry Dispersion Formulation BNC210 ng/ml 750 500- 250 000 750 500- 250 0 0 1 2 3 4 6 300 mg Solid Dose Tablet -- Fasted High Fat Meal T 8 T 10 12 Time (Hr) 18 20 Novel tablet overcomes food effect and has dose linear exposure 18 24#19BNC210 Phase 2b PTSD ATTUNE Study Underway WEEK 1 Phase 2b 1:1 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED BNC210 MONOTHERAPY IN PTSD PATIENTS -200 Subjects Bionomics 2 3 4 5 OUTPATIENT BID DOSING 6 7 BNC 210 900 mg oral tablet PLACEBO SECONDARY ENDPOINTS 9 Various patient-reported symptoms of PTSD, changes in anxiety and depression symptoms, and global and social functioning; Safety & tolerability endpoints 10 11 12 FOLLOW-UP PRIMARY ENDPOINT Investigator-rated PTSD symptoms on CAPS-5 Total Symptom Severity Scores in change from Baseline to Week 12 compared to placebo Fast Track designation from FDA BID = Twice daily dosing CAPS-5 = Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 15 欧 ATTUNE Study 19 PHASE 2b Single potential registrational- supporting trial for monotherapy treatment in PTSD KEY INCLUSION CRITERIA Female and male (18-75 years) Current PTSD diagnosis CAPS-5≥ 30 (Screening & Baseline) (& ≤ 25% decrease Screening to Baseline) ~25 Sites Topline data expected 1H'23#20CNS-focused Collaborations 프 Bionomics 20#21Ongoing Strategic Collaboration with Merck & Co. MSD Collaboration Overview Development Updates Bionomics ● Entered into in 2014 to develop a7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer's disease and other central nervous system conditions Merck funds all R&D activities including clinical development and WW commercialization of any products from collaboration Milestone payments of US$20M upfront and US$10M in 2017 when 1st compound entered Phase 1 clinical trials Eligible to receive up to US$465M in additional development and commercial milestone payments plus royalties Includes 2 candidates which are PAMs of the a7 receptor in early-stage Phase 1 safety and biomarker clinical trials for treating cognitive impairment The 1st compound has completed Phase 1 safety clinical trials in healthy subjects and there are ongoing plans for further biomarker studies In 2020, a second molecule that showed an improved potency profile in preclinical animal models was advanced by Merck into Phase 1 clinical trials MERCK PARTNERSHIP Snapshot of Early BNC375 Studies A 1001 Recognition (%) 80- 60- 40- 20- * Veh Wang et al. J Pharmacol Exp Ther 373:311-324, May 2020 https://pubmed.ncbi.nlm.nih.gov/32094294/ PAM = Positive allosteric modulator MSD = A tradename of Merck & Co., Inc., Kenilworth NJ USA -- Scopolamine (1 mpk, IP) --- 0 0.01 0.1 1 10 Don BNC375 (mg/kg, PO) A % Correct Difficult Trials 100- 80- 60- 40- 20- * V 0 Scopolamine 0.1 1 BNC375 (mg/kg, PO) 10 % Correct Difficult Trials 100- 50- 0 * 0 3 BNC 375 (mg/kg, IM) 21#22MOU for BNC210 and MDMA Derivative (EMP-01) for Post-Traumatic Stress Disorder Joint Feasibility Assessment with: EmpathBio EMP-01 = 3,4-Methylenedioxymethamphetamine (MDMA) derivative Bionomics ATAI LIFE SCIENCES DAILY NEWS Word - Business Finance Lifestyle Travel Sport Weather 22 February 2021 ● ● ● Memorandum of Understanding with EmpathBio's MDMA Derivative Illustrative Initial collaborative framework of preclinical studies to collectively explore a combination drug treatment regimen with BNC210 and EMP-01 MDMA-assisted psychotherapy has demonstrated significant symptom improvement in PTSD patients FDA has granted a Breakthrough Therapy designation to MDMA-assisted psychotherapy EmpathBio is developing MDMA derivatives that may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects To explore the possibility of a combination treatment regimen warranting clinical evaluation 22#23Investment Highlights & Stock and Financial Information Bionomics 23#24Stock and Financial Snapshot¹ ✓ Listing on two global exchanges ✓ Lean operations with modest burn ✓ Well-capitalized through CY2023 ✓ A$40.4M (US$29.2M) of net cash Leading Significant Investors: APEIRON BVF INVESTMENT GROUP PRESIGHT Bionomics PARTNERS L.P. MERCK S&P/ASX 200 4919.1 35572 PC53045 Hy 53045 5304 Low 48737 52 W High PEDR ASX 90 Day Bank Bill Futures 99.39 Previous Case Day Hu www AMA Figures as of December 31, 2021. US dollar figures illustrative- Based on exchange rate of 1.38 as published by the Reserve Bank of Australia as of Dec. 31, 2021. y Sentie 11200 5,300 5.250 5.200 ASX Debut: 1999 5,100 1050 5000 Bionomics 4950 Commodities Name GOLD SPOT SILVER SPOT PALLADIUM SPOT 98.42 PLATINUM SPOT ICE BRENT CRUIDE Last 556.78 20.01 127 15.43 0.38 247% 1851.84 20.01 1.09% 763.55 0.53 0.07% 32.75 0.45 138 X ASX ASX SHAYO BID OFF 0.005 0.0 0.225 0.2 0.000 0.0 0.053 00 SILEX SYSTEMS SILVER HERITAGE SILVER MINES SILVERCITY SILVERLAKE SIMAVITA 0.008 0.0 1.145 1.1 0.015 0.0 SIMBLE SOLUTION 0.010 0.0 SIMONDS GROUP 0.235 03 SIMS METAL SINETECH 6.720 6.7 0.000 0.0 STOCK SIPA RESOURCES 0.040 0.0 SITE GROUP INTEL 0.047 0.0 SIV ASSET MANA 0.000 0.0 SIV CAPITL 0.480 0.4 SIX SIGMA METAL 0.002 0.0 SKIN ELEMENTS 0.000 0.00 SKY AND SPACE F 0.000 0.00 SKYFI LTD SKYMETALS 0.125 0.1: 0.170 0.10 SLATER & GORDO 0.750 0.75 SMART MARINES 0.071 0.0 PER EX NOW NETFL EXCL ASX: BNO Nasdaq: BNOX NASDAQ WELCOMES BIONOMICS LIMITED JANUARY 14, 2022 BNOX NasdaqListed 8 Nasdaq Bionomics 24 HAM#25Bionomics Outlook: Renewed Value-driving Trajectory Bionomics Bionomics Diversified model with multiple value-driving clinical milestones expected in the next 4 – 6 quarters F BNC210's novel rapid onset formulation granted Fast Track designation for acute treatment of SAD Established clinical proof-of-concept¹; expect Phase 2 topline data by YE'22 F BNC210 Phase 2b ATTUNE PTSD study under way with Fast Track designation for 1H'23 topline data Tablet formulation achieves exposure projected from pharmacometric analysis 000 Merck strategic partnership for treatment of cognitive impairment in Alzheimer's disease with two compounds in clinical development Diverse early-stage pipeline of partnering prospects targeting Kv and Nav ion channels for treatment of schizophrenia and pain, respectively Well-capitalized balance sheet driven by experienced leadership 25 SAD Social Anxiety Disorder PTSD= Post-Traumatic Stress Disorder 1. Wise T. et al., Biological Psychiatry 2020 (https://doi.org/10.1016/j.biopsych.2019.12.013); Perkins A. et al., Translational Psychiatry 2021 (https://doi.org/10.1038/s41398-020-01141-5)#26APPENDIX: Management Team & Board of Directors. Bionomics 26#27Powered by a Seasoned and Experienced Management Team Archemix *AVE Aventis BIODEL Bionomics Errol De Souza, PhD Executive Chairman Liz Doolin VP Clinical Development CATALYST BIOSCIENCES cyclerion Circumvent Pharma Deloitte. 1. Logos reflect experience in current and/or past roles. DUPONT IDEXX LABORATORIES LINK IMMUNOTHERAPEUTICS 18 Connor Bernstein VP Strategy, Corporate Development & IR Adrian Hinton Interim Chief Financial Officer Neurocrine BIOSCIENCES NEUROPORE THERAPIESINE PALATIN PIPER SANDLER ROYALTY PHARMA RBC Capital Markets RBC Synaptic p Tharma Ltd. BOARD OF DIRECTORS ¹ 1 11 Errol De Souza PhD Executive Chairman David Wilson Non-Executive Director Alan Fisher Non-Executive Director Jane Ryan PhD Non-Executive Director Aaron Weaver Apeiron Nominee Miles Davies Apeiron Nominee Bionomics &Lybrand 27 WGpartners PiperJaffray. 3 ALLIANCE australaimited CENTREPOINT ANATARA LIFESCIENCES BCAL diagnostics at blidering for every women, eserywbem. APEIRON INVESTMENT GROUP atai A&O LIFE SCIENCES APEIRON INVESTMENT GROUP Rothschild & Co#28APPENDIX: BNC210 Prior Clinical Trial Information Bionomics 28#29Compelling Rationale in a Multifaceted Disorder ✓Enhanced fear extinction in mice and emotional recovery in humans following panic attack (CCK-4 Trial) ✓Antidepressant effect trends at early time points in PTSD patients (Phase 2B Study) ✓ Antidepressant effects in rodent model of depression Bionomics INTRUSIVE * Flashbacks * Nightmares SIVE THOUGHTS Physiological reactions to trauma reminders * Anhedonia * Social withdrawal COGNITIONS & MOOD BNC210 FOR PTSD MECHANISM & PHARMACOLOGY OF BNC210 (PRECLIN / CLIN) SUPPORT ITS THERAPEUTIC POTENTIAL FOR SEVERAL PTSD SYMPTOMS * Negative perception of self and world Avoiding trauma-related: * People * Places AVOIDANCE x Activiti es * Irritability * Aggression * Hypervigilance * Problems * Sleep concentrating disturbances ✓ Reduced threat avoidance behavior in humans (GAD Phase 2) and several animal models of (threat) ✓ Reduced number and intensity panic symptoms and intensity in humans (CCK4 challenge Phase 1) ✓ Reduces amygdala hyperactivity - a feature shared by patients with anxiety and/or PTSD (GAD Phase 2) ✓ Reduced anxious behavior in rodent models ✓ Inhibition of a7 nAChR inhibits release of excitatory neurotransmitters - potential to reduce NA induced hyperarousal (in vivo micro-dialysis in rat) AROUSAL & REACTI 29#30Phase 1 1 1 1b 1b 1b 1 1 1 2a 2a 2 Summary of BNC210 Clinical Trials: Excellent Safety and Tolerability Profile in Healthy Subjects and Patients 2b Description Single Ascending Dose Safety and PK Single Ascending Dose Safety and PK; Food Effect Single Ascending Dose Safety and PK; Food Effect Lorazepam Comparison CCK-4 Panic Attack Model Multiple Ascending Dose Safety and PK; Expanded Cohort for EEG Target Engagement Suspension and Tablet Formulation PK Comparison Single Ascending Dose Safety and PK Multiple Dosing Safety and PK Imaging and Behavioral Study In Generalized Anxiety Disorder Agitation in the Elderly in Hospital Setting Bionomics Post-Traumatic Stress Disorder Post-Traumatic Stress Disorder Participants / Setting Healthy volunteers / In-clinic Healthy volunteers / In-clinic Healthy volunteers / In-clinic Healthy volunteers / In-clinic Healthy volunteers / In-clinic Healthy volunteers / In-clinic EEG Electroencephalography PK Pharmacokinetic Healthy volunteers / In-clinic Healthy volunteers / In-clinic Healthy volunteers / In-clinic Generalized anxiety disorder patients / In-clinic Agitated elderly patients / Hospital Post-traumatic stress disorder patients / Out-patient Post-traumatic stress disorder patients / Out-patient * The number of enrolled subjects who were administered BNC210; other enrolled subjects were administered placebo only CCK-4 = Cholecystokinin Tetrapeptide Subjects Enrolled / Administered BNC210* 32/24 4/3 47/40 24/22 60/59 56/44 6/6 5/5 10/10 27/25 38/18 193/143 Ongoing BNC210 Formulation and Doses Suspension; single doses (5 to 2000 mg) Suspension; single doses (300 to 2000 mg) Capsule; single doses (300 to 3000 mg) Suspension; single doses (300 and 2000 mg) Suspension; single doses (2000 mg) Suspension; multiple doses (150 to 1000 mg twice daily for 8 days) Suspension and tablet; single doses (300 mg) Tablet; single doses (600 to 1200 mg) Tablet; multiple doses (900 mg twice daily for 7 days) Suspension; single doses (300 and 2000 mg) Suspension; multiple doses (300 mg twice daily for 5 days) Suspension; multiple doses (150, 300 or 600 mg twice daily for 12 weeks) Tablet; multiple doses (900 mg twice daily for 12 weeks) Location Australia Australia US 30 France France France Australia Australia Australia UK Australia Australia US US#31Mechanistic Validation of BNC210 as Evidenced by EEG Response BNC210 blood-brain barrier penetration and nicotinic receptor target engagement in humans Bionomics Power in alpha2 band ** BNC210 Reduced Nicotine-induced EEG Responses 1.5 1.0- 0.5- 0.0 0.0 nAChR=Nicotinic Acetylcholine Receptor EEG Electroencephalography p-value less than 0.05 p-value less than 0.01 M Day -1 without BNC210 Day 7 with BNC210 NS 0.5 ** p=0.0062 1.0 Nicotine (mg) ** p=0.0026 1.5 p=0.0487 2.0 Activation of nicotinic receptors in the brain induces EEG response a432 and a 7 receptors are the major nACHR populations targeted BNC210 daily oral dosing reduced nicotine-induced EEG in the a2 band Observed reduction in EEG response due to BNC210's negative allosteric modulation of the a 7 receptors 31#32Phase 2 Trial of BNC210 in Adults with Post-Traumatic Stress Disorder (PTSD) restore 32 ¡¡¡¡¡ A Bionomics Study Design Key Selection Criteria Key Study Objectives 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.) 12-week treatment period • 193 participants 20 US sites / 6 Australian sites Current diagnosis of PTSD as defined by CAPS-5 (Clinician- Administered PTSD Scale for DSM-5) • To assess the effects of BNC210 on investigator-rated symptoms of PTSD measured by CAPS-5 • To assess the safety and tolerability of BNC210 in subjects with PTSD#33BNC210 PTSD Trial Overall Conclusions 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 in high dose treatment group in total population ✓CAPS-5 Criterion D overall (negative alterations in cognitions and mood) statistically significant at Week 1 (p<0.05) ✓CAPS-5 Criterion D, Question 2 (persistent and exaggerated negative beliefs or expectations) statistically significant at Week 1 (p=0.001) ✓CAPS-5 Criterion D, Question 4 (persistent negative emotional state) statistically significant at Weeks 4 and 8 (p<0.05) Trend for anxiolytic effect in high dose treatment group in the total population ✓ Trend towards improvement on CAPS-5 Criterion E (marked alterations in arousal and reactivity), Question 3 (hypervigilance) ✓Trend towards improvement on CAPS-5 Criterion E, Question 4 (exaggerated startle response) BNC210 was well tolerated in patients with PTSD ✓No trend for increased adverse events with treatment restore ✓No evidence of cognitive impairment ✓ No evidence of suicidal ideation or behavior worsening Potential reasons why clinically significant effects and trends seen at early time points did not translate into significant primary endpoint on CAPS-5 at 12 Weeks Inadequate overall blood exposure of BNC210 Lower compliance with liquid suspension formulation which needed to be taken with food Bionomics 33#34Emerging CNS Pipeline for Partnering Bionomics 34#35Kv3.1 / Kv3.2 Ion Channel Activators for Cognitive Dysfunction and Negative Symptoms Promising therapeutic strategy for improving cognitive disfunction and social withdrawal symptoms -600 COMPOUNDS SYNTHESIZED Bionomics 2 SERIES PATENTED Lead Compound BL-76 Back-up Compounds 2 Patents Published Bionomics' molecules target Kv3.1/3.2 ion channels on parvalbumin positive, gabaergic interneurons in the pre-frontal cortex Spontaneous a Ite rn a tion (%) 80 40 20 Potential in schizophrenia, Autism Spectrum disorders and conditions with cognitive impairments 0 Lead Compound BL-76 Fully Reverses PCP-induced Cognitive Deficit in Mice in the T-maze 100% -0% -75% -43% - 70% - 103% REVERSAL OF PCP EFFECTS Vehicle PCP 3 mg/kg sc Risperidone 0.001 mg/kg ip /P C P BL-7 6 3 m g/kg po/P C P BL-7 6 1 0 mg/kg po/P CP BL-76 30 m g/kg po/P C P 35#36Pan Nav Inhibitors: Potential Non-Addictive, Reduced Side-Effect Chronic Pain Therapies Disease-Related Genetics BNO Pan Nav inhibitors Small molecules with functional selectivity for voltage gated sodium channels: Nav1.7, Nav 1.8 and potentially Ναν 1.9 Bionomics Gain & Loss-of-function mutations in Nav 1.7, 1.8 and 1.9 1000+ COMPOUNDS SYNTHESIZED 2 SERIES PATENTED LEAD COMPOUND BL-017881 BACK-UP COMPOUNDS 3 Patents Published Associated with human pain syndromes where extreme pain or no pain is experienced Lead Candidate Identified BL-017881 OBSERVED TO REVERSE PAIN IN THE FORMALIN PAW MODEL IN MICE 36#37APPENDIX: Building Value Through Legacy Oncology Assets Bionomics 37#38Legacy Oncology Asset Monetization to Drive Value: BNC101 Exclusive BNC101 Oncology License Agreement for the Development of CAR-T Therapeutics #carina biotech Bionomics Exclusive Agreement to license Bionomics' BNC101 oncology drug candidate to Carina Biotech for the development of Chimeric Antigen Receptor T cell (CAR-T) therapy, which harnesses the body's immune system to fight cancer. Bionomics is eligible to receive up to A$118 million in clinical & development milestones plus royalty payments if Carina fully develops and markets the new therapy. In the event that Carina sub-licenses the CAR-T treatment, Bionomics is eligible to share in the sub-licensing revenues in early clinical development and receive a substantial double-digit portion of the revenues in later stages of clinical development. In September 2021, Carina announced that it plans to initiate a clinical trial of BNC101 CAR-T therapy for the treatment of advanced colorectal (bowel) cancer in late 2022 Bionomics retains BNC101 for other types of therapies 38

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare