Neuphoria Therapeutics Inc. · NASDAQ:NEUP
Neuphoria Therapeutics — Investor Presentation (2025)
40 slides from Neuphoria Therapeutics's investor presentation, 2025
Slide 1: Pioneering breakthrough therapies for neuropsychiatric disorders
Dedicated to pioneering breakthrough therapies that address the complex needs of individuals affected by neuropsychiatric disorders. NASDAQ: NEUP
Slide 2: Forward-Looking Statements
Forward-Looking Statements Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predi
Slide 3: A Growing Health Crisis
A Growing Health Crisis The rise of stress and anxiety disorders Nearly one in four adults are affected by stress ~31M adults at some point in and anxiety disorders each year, profoundly their lives have SAD impacting their daily lives. Available treatments such as Selective Serotonin Reuptake ~21M
Slide 4: Neuphoria's Robust Pipeline with Multiple R&D Catalysts
Neuphoria’s Robust Pipeline with Multiple R&D Catalysts PROGRAM INDICATION DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Post-Traumatic Stress Disorder (PTSD) INTERNAL α7 receptor Social Anxiety NAM Disorder (SAD) BNC210 Other (Generalized Anxiety Disorder & Panic Disorder) Alzheimer’s Disease (AD)
Slide 5: BNC210 (soclenicant) Program Overview
BNC210 (soclenicant) Program Overview /
Slide 6: BNC210: A Potential Best- and First-in-Class α7 Nicotinic Receptor NAM
BNC210: A Potential Best- and First-in-Class α7 Nicotinic Receptor Small Molecule Negative Allosteric Modulator (NAM) Novel MoA • Unique and differentiated MoA with high confidence in rationale and probabilities of success Reduction of PTSD symptom severity Reduction of anxiety in panic attacks, GAD
Slide 7: BNC210's Potential Advantages
BNC210’s Potential Advantages *7 Highly differentiated compared to standard of care and late-stage experimental therapeutics Benzodiazepines† Experimental BNC210 SSRIs / SNRIs§ Off-label use Psychedelics Urgent need for broad acting therapy with fast onset of action Fast Acting X X and improved safe
Slide 8: Successful EoPh2 FDA Meetings for Both PTSD & SAD
Successful EoPh2 FDA Meetings for Both PTSD & SAD Paving the Way For Phase 3 Initiation & NDA Submissions Without Delays Clinical Plan Ph3 Design Elements Common One additional Phase 3 trial with Agreement was reached on PTSD a 12-week randomized, double- patient characteristics, dose, blind, placeb
Slide 9: BNC210 Clinical Development in Stress and Anxiety Disorders
BNC210 Clinical Development in Stress and Anxiety Disorders Overview of Studies and Next Milestones Panic Attacks GAD SAD PTSD BNC210.004* BNC210.006* PREVAIL BNC210.013 AFFIRM-1 AFFIRM-2 ATTUNE SYMPHONY (Phase 1b) (Phase 2) (Phase 2) BNC210.014 BNC210.015 BNC210.012 (Phase 2b/3) (Phase 3) (Phase 3)
Slide 10: BNC210 Clinical Development Plan
BNC210 Clinical Development Plan 2025 2026 2027 2028 2029 IA & DOSING DECISION PTSD PHASE 2b (8-WEEK) ($11M) PTSD PHASE 3 (12-WEEK) ($25M) PTSD Program OPEN LABEL SAFETY EXTENSION ($20M) PHASE 3 EFFICACY TRIAL PHASE 3 EFFICACY TRIAL ($10-$15M) ($9.2M) SAD Program PHASE 3 OPEN LABEL SAFETY TRIAL ($15
Slide 11: BNC210 (soclenicant) for SAD
BNC210 (soclenicant) for SAD /
Slide 12: Social Anxiety Disorder
Social Anxiety Disorder • Fear of scrutiny, embarrassment and negative evaluation • View criticisms and imperfect social performance as catastrophic • Fear that others will notice anxiety symptoms resulting in severe embarrassment • Worry about consequences - Others will think poorly of him/her • Ca
Slide 13: Unmet Needs in SAD
Unmet Needs in SAD Market research underscores the lack of safe, non-habit-forming therapies, particularly in the acute setting “It would be highly advantageous if • Psychiatrists emphasize the need for therapies, as PRN (”as-needed”), something worked as well as a BZD Safer, Non-habit without the s
Slide 14: PREVAIL Phase 2 Trial Design
PREVAIL Phase 2 Trial Design Screening Liebowitz Social Anxiety Scale (LSAS) 1:1:1 Randomization (Double-blind) >95: Very severe social phobia SINGLE DOSE ADMINISTRATION 80–95: Severe social phobia 65–80: Marked social phobia ~50 ~50 225mg ~50 675mg ~50 Placebo 55–65: Moderate social phobia Primary
Slide 15: Subject Disposition and Baseline Demographics
Subject Disposition and Baseline Demographics Subject Disposition BNC210 225 mg BNC210 675 mg BNC210 Overall Placebo Overall Randomized/Safety/Full Analysis*/trial 50 51 101 50 151 Completer Population Per Protocol Population** 50 51 101 49 150 Baseline Characteristics Mean Age in Years (Min, Max) 3
Slide 16: Acute BNC210 Administration Reduced Anxiety During the Public Speaking Task
Acute BNC210 Administration Reduced Anxiety During the Public Speaking Task Mean Change in SUDS Individual Arms Overall Baseline More SUDS = 37 (SD: 21.10) Anxiety Mean Δ from Baseline Performance Average p = 0.164 (225mg)* ANTICIPATION PERFORMANCE POST-SPEECH Placebo (n=50) 225mg (n=50) 675mg (n=51
Slide 17: BNC210 Showed a Placebo-like Safety Profile in SAD
BNC210 Showed a Placebo-like Safety Profile in SAD Number of Subjects PLACEBO BNC210 225 mg BNC210 675 mg OVERALL With at Least 1 TEAE (%) 3 (6.0) 7 (14.0) 11 (21.6) 21 (13.9) By Relationship to trial Drug Possibly/Probably/Definitely (%) 0/2/0 (0/4.9/0) 3/3/0 (6.0/6.0/0) 2/7/0 (3.9/13.7/0) 5/12/0 (
Slide 18: BNC210: Target Product Profile in SAD
BNC210: Target Product Profile in SAD PREVAIL Ph2 trial results delivered a differentiated TPP Fast Acting Anxiolytic Clinical effects in ~1 hour Durable Effect ~5-hour half-life support full day coverage with 2 doses Clinically Meaningful Efficacy Benzodiazepine-like efficacy for anxiety reduction
Slide 19: NDA-enabling Ph3 Program for BNC210 in SAD
NDA-enabling Ph3 Program for BNC210 for As-needed Treatment of Anxiety in SAD AFFIRM-1 2 AFFIRM-2 Open-label Safety 225 mg BNC210 vs. placebo 75 mg and 225 mg BNC210 vs. placebo 225 mg BNC210 Screening Randomization Screening • Adults aged 18 to 65 years SINGLE DOSE ADMINISTRATION • Adults aged 18 t
Slide 20: Phase 3 SAD Study Endpoints
Phase 3 SAD Study Endpoints 225mg BNC210 vs. placebo Primary during an anxiety-provoking • Change in SUDS scores from Baseline to the average of the performance phase public speaking challenge: Secondary • Change in SUDS scores from Baseline to the average of the anticipation phase • Change in CGI-S
Slide 21: In Ph2 BNC210 Demonstrated Anxiety Reduction Comparable to Benzodiazepines
Clinical Meaningfulness: In Ph2 BNC210 Demonstrated Reduction in Anxiety Comparable in Magnitude to Benzodiazepines Mean Change from Baseline in SUDS BNC210: Mean Change in SUDS Diazepam 10 mg* Phase 2 PREVAIL Study /
Slide 22: BNC210 Reduced Threat Avoidance Behavior and Anxiety in GAD Patients
BNC210 Reduced Threat Avoidance Behavior and Anxiety in GAD Patients Were Also Observed in a Separate Acute-Dose Ph2 PoC Trial* Ph2 GAD trial Ph2 GAD trial BNC210 ↓ threat avoidance BNC210 ↓ anxiety in GAD behaviour in GAD *Head-to-Head Comparison with a Benzodiazepine ANALYSIS SET (Lorazepam 1.5mg)
Slide 23: Determining Success in AFFIRM-1: Interpreting SUDS Outcomes
Determining Success in AFFIRM-1: Interpreting SUDS Outcomes P>0.05 (statistically non-significant) p<0.05 (statistically significant) SUDS Δ from placebo 3 4 5 6 7 8 SUDS <3: Do not proceed SUDS = 5-6: Proceed SUDS > 6: Expedite Similar to Vanda Pharmaceuticals Similar to Vistagen’s fasedienol in Be
Slide 24: Determining Success in AFFIRM-1: Additional Considerations
Determining Success in AFFIRM-1: Additional Considerations Is the SUDS difference from Is the SUDS difference Is the CGI-S difference Is the PGI-I or the STAI Yes between baseline Placebo- No from Placebo-BNC210 No Placebo-BNC210 baseline Placebo-BNC210 significant p<0.05? BNC210 >5? significant? si
Slide 25: BNC210 for PTSD Program Overview
BNC210 for PTSD Program Overview /
Slide 26: PTSD is a Complex Neuropsychiatric Disorder
PTSD is a Complex Neuropsychiatric Disorder Preclinical studies, Phase 1b CCK-4 trial & Phase 2 trials in PTSD, GAD & SAD support BNC210’s potential utility in PTSD Av eh gh e ou siv oi av ts b da io Avoiding th tru û Nightmare • ATTUNE Ph2b data nc r In s trauma-related: ATTUNE Ph2b data Thought ↓
Slide 27: Unmet Needs in PTSD
Unmet Needs in PTSD Market research underscores the need for more novel, targeted MOAs and additional chronic agents with more favorable effi cacy/tolerability • Psychiatrists agree there is a significant need for novel MOAs capable of “Our current options in PTSD are repurposed drugs. We need drugs
Slide 28: ATTUNE Was Designed as a Registrational Trial of BNC210 in PTSD
ATTUNE was Designed as a Registrational Trial of BNC210 in PTSD Patients Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 15 Outpatient dosing (N=212 randomized) Follow-Up BNC210 900 mg oral tablet BID Placebo oral tablet BID Primary Endpoint Key Inclusion
Slide 29: In ATTUNE, BNC210 Significantly Reduced PTSD Symptom Severity
In ATTUNE, BNC210 Significantly Reduced PTSD Symptom Severity and Informed Ph2b/3 Study Design Clinically Meaningful Treatment Effects/Effect Sizes During 12 Weeks of Treatment, Early Onset of Effect SYMPHONY Ph2b/3 TRIAL DESIGN • Two Cohort Design • Cohort 1: 8-week RCT to evaluate safety and effi
Slide 30: Multiple Secondary Endpoint Improvements
Multiple Secondary Endpoint Improvements Significant Outcome Measures of Sleep, Depressive Symptoms, & Thought Intrusions ISI Sleep Scores MADRS Depression Scores CAPS-5 Intrusion Criterion * * * * * * * *P<0.05 *P<0.05 *P<0.05 /
Slide 31: BNC210 Also Significantly Reduced PTSD Symptoms at Week 8
BNC210 Also Significantly Reduced PTSD Symptoms at week 8 Strong separation from placebo at Week 8 on CAPS-5 & other endpoints supports primary endpoint at week 8 in Ph2b/3 trial Endpoint LS mean difference from placebo p-value Clinician Administered PTSD Scale (CAPS-5) -4.74 0.014 CAPS-5 Intrusion
Slide 32: ATTUNE Enables the Design of the PTSD Ph3 Program
ATTUNE Enables the Design of the PTSD Ph3 Program BNC210 Efficacy & Safety • Evidence of clinically meaningful effi cacy across primary and several secondary endpoints when administered as monotherapy • Effi cacy onset as early as 4 weeks • AE profile suggests limited potential for addiction, sexual
Slide 33: BNC210: Target Product Profile in PTSD
BNC210: Target Product Profile in PTSD ATTUNE Ph2b trial results delivered a differentiated TPP Fast Acting Full efficacy is achieved as quickly as Week 4 (CAPS-5 Total Symptom Severity p=0.015) Durable Effect Full efficacy sustained over a period of 12 weeks (CAPS-5 Total Symptom Severity effect si
Slide 34: MK-1167 for Alzheimer's Disease Program Overview
MK-1167 for Alzheimer’s Disease Program Overview /
Slide 35: Merck Strategic Collaboration
Merck Strategic Collaboration MSD Collaboration Overview Development Updates • Neuphoria has an exclusive Research Collaboration • Two α7 receptor PAM candidates in clinical with MSD to develop α7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer’s development for the treatment
Slide 36: α7 PAM Clinical Trial Development to date
α7 PAM Clinical Trial Development to date MK-1167 (second generation clinical candidate) Jun 2014 $20M upfront payment on licensing the α7 Phase 1 Phase 2 PAM program to MSD Aug 2022 to Nov 2023 Dec 2024 to Dec 2026 (estimated) NL-OMON51348 MK-1167-008 / NCT06721156 • Biomarker study in healthy part
Slide 37: Key Milestones: Demonstrated Progress and Clear Path Forward
Key Milestones: Demonstrated Progress and Clear Path Forward 2H 2025 • AFFIRM-1 SAD Ph3 readout We've made significant progress over the past 2.5 years: ✓ Generated robust clinical datasets across multiple 1H 2026 anxiety indications • AFFIRM-2 SAD Ph3 Initiation • PTSD Ph2b/3 study Initiation ✓ Sec
Slide 38: Summary
Summary • Strong, diversified pipeline with three advanced clinical stage programs • BNC210 has demonstrated efficacy in multiple anxiety indications – Topline SAD Ph3 readout approaching in October, 2025 • Merck collaboration expands our pipeline and validates our ion channel platform robustness an
Slide 39: A Proven Management Team
A Proven Management Team Successful NDAs, Drug Launches, Capital Raises & Strategic Deals Spyros Papapetropoulos, MD, PhD Tim Cunningham, CPA, MBA President & CEO CFO Mark A. Smith, MD, PhD Matthew Brennan, MBA Chief Medical Officer VP, Business Development Strong Experience in R&D Programs & Brand
Slide 40: Thank you
Thank you Spyros Papapetropoulos MD, PhD
Neuphoria Therapeutics — Investor Presentation (2025) on 6ix