Reviva Pharmaceuticals Holdings, Inc. · NASDAQ:RVPH
Reviva Pharmaceuticals — Technical Presentation (June 2025)
41 slides from Reviva Pharmaceuticals's technical presentation, Jun 2, 2025
Slide 1: Phase 3 RECOVER Open-Label Extension Trial of Brilaroxazine in Schizophrenia
(Reviva Reviva Pharmaceuticals Phase 3 RECOVER Open-Label Extension (OLE) Trial of Brilaroxazine in Schizophrenia June 2, 2025 at 8:00am EDT
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains certain forward-looking statements within the mearing of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Secures Ligation Reform Act, as amended, including those relating to the Company
Slide 3: Agenda
Agenda Welcome and Introduction Welcome and Introduction Laxminarayan Bhat, PhD, Founder, President and CEO Reviva Pharmaceuticals Two Brilaroxazine Phase 3 RECOVER OLE Trial Efficacy Results ‘Stephen R Marder, MD. Professor, Psychiatry and Biobehavioral Sciences University of California, Los Angele
Slide 4: Stephen R Marder, MD
Stephen R Marder, MD > Professor, Psychiatry and Biobehavioral Sciences University of California, Los Angeles ‘Steve Marder is the Daniel X. Freedman Professor of Psychiatry, the Vice Chair for Education, and the Director ofthe Section on Psychosis at the UCLA Semel Institute for Neurascience and Hu
Slide 5: Larry Ereshefsky, PharmD, BCPP, FCCP
Larry Ereshefsky, PharmD, BCPP, FCCP } Retired professor of Psychiatry, Pharmacology and Psychiatry the University of Texas f\ Chief Scientific Officer, Owner of Follow the Molecule LLC Larry Eresheteky over his 45 years’ career applies his experience as clinician, scientist and investigator, to dev
Slide 6: Results of brilaroxazine Phase 3 RECOVER trial
Reviva Results of brilaroxazine HK Phase 3 RECOVER trial Successfully met the study iN endpoints and objectives long-term efficacy, safety and compliance in schizophrenia
Slide 7: Brilaroxazine
Brilaroxazine Differentiated clinical profile with potential to address unmet needs across the treatment of schizophrenia Durable Multi-domain Efficacy
Slide 8: Positive Registrational Trials for Brilaroxazine in Schizophrenia
Positive Registrational Trials for Brilaroxazine in Schizophrenia Completed required NDA-enabling safety pharmacology, toxicology & carcinogenicity studies, & CMC development. PHASE 1A and 16, Clin Pharm Studies (N=150) PHASE 2 REFRESH 1 PHASE 3 RECOVERDB PHASE 3 RECOVER OLE Phase 18 Healthy subject
Slide 9: Brilaroxazine Phase 3 Study (RECOVER) Long-term Efficacy and Compliance Results
Brilaroxazine Phase 3 Study (RECOVER) Long-term Efficacy and Compliance Results Stephen R Marder, MD Professor, Psychiatry and Biobehavioral Sciences University of California, Los Angeles
Slide 10: Schizophrenia: Common Psychiatric Condition With Multiple Symptom Domains
Schizophrenia: Common Psychiatric Condition With Multiple Symptom Domains Affects ~1.1% of the world’s population Major Symptom Domains of Schizophrenia © ~24 million people globally Primarily. pence be ingore ‘serotonin © ~3.5 million people in USA Mix of heterogenous psychotic symptoms with nai va
Slide 11: No Current Therapies Address all Needs of Patients with Schizophrenia
No Current Therapies Address all Needs of Patients with Schizophrenia Suboptimal efficacy and side effects of current treatments continue to limit long-term use for this chronic condition Suboptimal Poor Tolerability/ Efficacy Side Effects Current treatment ++ Current treatments are inadequate to ad
Slide 12: Brilaroxazine: Novel Serotonin Dopamine Signaling Modulator
Brilaroxazine: Novel Serotonin Dopamine Signaling Modulator Multi-faceted direct and indirect activities on critical pathways implicated in schizophrenia Brilaroxazine Receptor Activities Dopamine D; oa? High (1, nt)" Dopamine D, a7 Dopamine D, 6 z ‘Moderate (Ki,nM) ests | —— Indirect modulation of
Slide 13: Brilaroxazine Phase 3 RECOVER Trial For Schizophrenia
Brilaroxazine Phase 3 RECOVER Trial For Schizophrenia Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine in Subjects with an Acute Exacerbation of Schizophrenia, Followed by a 52-Week Open-label Extension vet N=140 Rol
Slide 14: Brilaroxazine Phase 3 Trial: Favorable Efficacy, Safety & Discontinuation
Brilaroxazine Phase 3 Trial: Favorable Efficacy, Safety & Discontinuation ‘Strong broad-spectrum efficacy further supported by vocal biomarker (VBM) and blood biomarkers ‘Symptom Domains & Adherence Digital Biomarkers, VBM Blood Biomarkers All Patients, Prominent Negative Symptoms All Patients, Bria
Slide 15: RECOVER Open-Label Trial Demographics and Baseline Characteristics
RECOVER Open-Label Trial Demographics and Baseline Characteristics Diverse patient representation with balanced enrollment across 3 doses (N=446) Brilaroxazine Ox Brilaroxazine Pooled mg 0 mg g 15. mg Patients enrolled, N 140 158 148 446" Male, N (2%) 82 (58.6) 102 (64.6) 102 (68.9) i 286 (64.1) Fem
Slide 16: Schizophrenia: Clinical Evaluation
Schizophrenia: Clinical Evaluation Scales and tools for evaluating brilaroxazine treatment effects in RECOVER trial for schizophrenia Positive and Negative Syndrome Scale (PANSS) Gold-standard outcome for antipsychotic efficacy, used in multinational clinical trials for >30 years (Kay. Opler, et al.
Slide 17: PANSS Total Score: Robust Broad-Spectrum Efficacy Sustained Over 1-year
PANSS Total Score: Robust Broad-Spectrum Efficacy Sustained Over 1-year 48-point decrease with brilaroxazine pooled (15, 30, and 50 mg) at Week-52 vs. baseline (p < 0.0001; n= 159) CHANGE IN PANSS TOTAL SCORE + Dose dependent decrease from baseline to Week-52 (1-year) = 16.0-point decrease in 15 mg
Slide 18: PANSS Total Score: Time and Dose-Dependent Decrease
PANSS Total Score: Time and Dose-Dependent Decrease 10.8-point (6-mos) & 18-point (12-mos) decrease with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p < 0.001) PANSS TOTAL SCORE ps0.001 ps 0.001 87 69.9 ically meaningful and sustained long-term efficacy + Significant decrease with brilaroxazi
Slide 19: PANSS Positive Symptoms Score: Time & Dose-Dependent Decrease
PANSS Positive Symptoms Score: Time & Dose-Dependent Decrease 3.3-point (6-mos) & 5-point (12-mos) decrease with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p < 0.001) DECREASE IN POSITIVE SYMPTOMS + Clinically meaningful and sustained long-term efficacy + Significant decrease with brilaroxaz
Slide 20: PANSS Negative Symptoms Score: Time & Dose-Dependent Decrease
PANSS Negative Symptoms Score: Time & Dose-Dependent Decrease 2.8-point (6-mos) & 4.4-point (12-mos) decrease with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p < 0.001) DECREASE IN NEGATIVE SYMPTOMS p< 0.001 p<0.001 + Clinically meaningful and sustained long-term efficacy 188 19.4 + Signific
Slide 21: PANSS Marder Scores for Negative Symptoms and Depression/Anxiety Symptoms
PANSS Marder Scores for Negative Symptoms and Depression/Anxiety Symptoms PANSS MARDER SCORES FOR NEGATIVE PANSS MARDER SCORES FOR SYMPTOMS DEPRESSION/ANXIETY SYMPTOMS p<0.001 p< 0.001 ps0.001 p<0.001 16.9 17.2 70 7A 13.9 oe 12.7 Baseline 6-month Easeine Aa month Baseline _6-month Baseline 12-month
Slide 22: PANSS Scores for Excitement/Agitation and Social Cognition
PANSS Scores for Excitement/Agitation and Social Cog} DECREASE IN SOCIAL COGNITION SYMPTOMS ps 0.001 p<0.001 13.0 129 Baseline 6-month Baseline 12-month N= 303 N=159 1.S:point (6-mos) & 2.8-point (12-mos) decrease with brilaroxazine pooled (15, 30 & 50 mg) vs baseline a Gu ion Symptoms DECREASE IN A
Slide 23: PANSS General Psychopathology Score: Time & Dose-Dependent Decrease
PANSS General Psychopathology Score: Time & Dose-Dependent Decrease 4.7-point (6-mos) & 8.7-point (12-mos) decrease with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p < 0.001) DECREASE IN GENERAL PSYCHOTIC SYMPTOMS p<0.001 p<0.001 + Clinically meaningful and sustained long-term efficacy 987 +
Slide 24: Personal & Social Performance Scores: Time & Dose-Dependent Increase
Personal & Social Performance Scores: Time & Dose-Dependent Increase 4.5-point (6-mos) & 11.2-point (12-mos) increase with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p < 0.001) IMPROVEMENT IN PERSONAL & SOCIAL ps0.001 ps0.001 PERFORMANCE 747 + Clinically meaningful and sustained long-term ef
Slide 25: CGI-S Score: Clinically Meaningful Improvement
CGI-S Score: Clinically Meaningful Improvement (>1 point) 37.3% (6-mos) & 58.5% (12-mos) of patients showed >1-point improvement with brilaroxazine pooled (15, 30, & 50 mg) vs. baseline (p < 0.001) PATIENTS WITH >1 POINT IMPROVEMENT ON CGI-S SCALE p<0001 + Clinically meaningful and sustained long-te
Slide 26: Brilaroxazine Phase 3 Trial OLE: Favorable Efficacy & Discontinuation
Brilaroxazine Phase 3 Trial OLE: Favorable Efficacy & Discontinuation Significant Improvements across all three doses of brilaroxazine from baseline to EOT (N=446) ‘Symptom Domains & Adherence Blood Biomarkers AllPatients All Patients Rollover Patients vont amet | rete ce, eae at 6M (N=303) at 12M (
Slide 27: RECOVER Conclusions: Wide-spectrum Durable Efficacy with Brilaroxazine
RECOVER Conclusions: Wide-spectrum Durable Efficacy with Brilaroxazine CONSISTENT, WIDE- SPECTRUM EFFICACY WELL-CONDUCTED TRIAL, HIGH-QUALITY DATA FAVORABLE EFFICACY/ SIDE-EFFECT RATIO POTENTIAL TO SIGNIFICANTLY ADDRESS UNMET NEEDS Reviva Improvement in multiple domains including: positive, negative
Slide 28: Brilaroxazine Phase 3 Study (RECOVER) Safety, Tolerability and Compliance
Brilaroxazine Phase 3 Study (RECOVER) Safety, Tolera and Compliance ity Dr. Larry Ereshefsky, PharmD, BCPP, FCCP Retired Professor of Psychiatry, Pharmacology and Psychiatry, The University of Texas Chief Scientific Officer, Owner Follow the Molecule LLC
Slide 29: Reflecting on the Past to Guide the Future
Reflecting on the Past to Guide the Future The need: better efficacy with fewer side effects Major Symptoms KEY UNMET NEEDS. Current standard of care antipsychotics are sub-optimal to treat chronic conditions negative, mood and cognitive symptoms Poor tolerability and prevalence of long- lasting sid
Slide 30: With Every Relapse, Patients are at Risk for Increased Brain Atrophy
With Every Relapse, In the Early Years of Illness, Patients are at Risk for Increased Brain Atrophy and Lifetime Functional Impairment Major unmet need to address = Improving treatment adherence and mitigating relapse of acute symptoms Prodvome 100 ZB wo +———_ Response 2 a 5 © 2 Chronic Relapsing Re
Slide 31: Brilaroxazine Phase 3 RECOVER Trial in Acute Schizophrenia
Brilaroxazine Phase 3 RECOVER Trial in Acute Schizophrenia Safety, Tolerability and Compliance (double-blind trial, 4-week, N=411) weicnc omg ne) wr) ‘Any Treatment Emergent Adverse Event (TEAE) 104 45%) 107 655%) 20 28.9%) Discontinuation, m (6) 26(186%) 22 (164%) 20 219%) TEAE occurringin>% partic
Slide 32: Brilaroxazine Phase 3 RECOVER Trial in Stable Schizophrenia
Brilaroxazine Phase 3 RECOVER Trial in Stable Schizophrenia Safety, Tolerability and Compliance (open-label trial for 52-week/1-year, N=446) Pay Brilaroxazine Britaroxazine Brilaroxazine Pooled 45mg (N=140) 30 mg (N=158) 0 mg (N=148) (w=446) [Number of Treatment Emergent Adverse Event (TEAE) 85 a 10
Slide 33: Bodyweight Change in Acute vs Stable Patients
Brilaroxazine Phase 3 Trial: Bodyweight Change in Acute vs Stable Patients Bodyweight change profile in acute in-patient vs stable out-patient trials with brilaroxazine from baseline to EOT ‘Acute Patients Stable Patients DB Inpatient Trial OLE Outpatient Trial 4-Week | N=411 24-Week | N=303 52-Week
Slide 34: Brilaroxazine Phase 3 OLE Trial: Change in Lipid Profile
Brilaroxazine Phase 3 OLE Trial: Change in Lipid Profile Decrease in cholesterol and LDL cholesterol across all doses in brilaroxazine from baseline to EOT (N=446, 12 mos) CHANGE IN SERUM CHOLESTEROL (MG/DL) CHANGE IN SERUM LDL (MG/DL) Base 12-mos Base 12mos Base 12mos Base 12:m0s Base 12mos Base 12
Slide 35: Lipids Change in Acute vs Stable Patients
Brilaroxazine Phase 3 Tri: ids Change in Acute vs Stable Patients Lipids change in acute in-patient vs stable out-patient trials with brilaroxazine (15, 30, 50 mg) from baseline to EOT Cholesterol, mg/dL LDL Cholesterol, mg/dL 111) | Stable Patients (1 11) | Stable Patients (N=446) OLE, 12 Months Br
Slide 36: Brilaroxazine Phase 3 OLE Trial: Change in Prolactin Hormone
Brilaroxazine Phase 3 OLE Trial: Change in Prolactin Hormone Clinically significant decrease in prolactin levels across all doses of brilaroxazine from baseline to EOT (N=446, 12 mos) DECREASE IN PROLACTIN + Clinically significant decrease in serum prolactin p<0.0001 levels across all doses of brila
Slide 37: Brilaroxazine Phase 3 OLE Trial: Change in Thyroid Hormone
Brilaroxazine Phase 3 OLE Trial: Change in Thyroid Hormone Improvement in thyroid hormone levels across all doses of brilaroxazine from baseline to EOT (N=446, 12 mos) IMPROVEMENT IN THYROID HORMONES + Improvement in thyroid (T3) hormone levels across all doses of brilaroxazine from baseline to week
Slide 38: Sexual Function, CSFQ Score: Improvement in both Males and Females
Sexual Function, CSFQ Score: Improvement in both Males and Females Improvement in sexual function CSFQ Score at 6-mos and 12-mos with brilaroxazine vs baseline (p < 0.001) ‘SEXUAL FUNCTION, CSFQ SCORE ps0.001 ps0.001 + Significant improvement in total sexual function score {psoon, Ps0.001 with brila
Slide 39: Brilaroxazine Phase 3 RECOVER OLE Trial Inflammatory Biomarker Data
Brilaroxazine Phase 3 RECOVER OLE Trial Inflammatory Biomarker Data Increase in BDNF & decrease in inflammatory cytokines and chemokines from baseline to EOT (N=446, 12 mos) m0 in Chei Save t2mos {Baw ‘amos Bain {20s Bane {205 Bae t2mos Bure i2os Bae i205 | Bove i208 Base 12on BDNF (ug/l) ‘IL-G (ng/
Slide 40: Brilaroxazine: Consistent Well-Tolerated Safety with Low Discontinuation Over 1-Year
n Over 1-Year Brilaroxazine: Consistent Well-Tolerated Safety with Low Discontinua’ Well-Tolerated Brilaroxazine (15, 30, and 50 mg) is safe and well-tolerated following 1-year of treatment. Most common TEAEs > 2% were headache (2.7%), insomnia (4.0%), sleep disturbance (2.9%) and mild tremor (3.1%)
Slide 41: Reviva Pharmaceuticals Holdings, Inc.
Reviva Pharmaceuticals Holdings, Inc. Business Inquiries: busdev.rp@Revivapharma.com Investor Relations: IR@Revivapharma.com Acknowledgement Key Opinion Leaders (KOLs) Dr. Stephen R Marder, MD Dr. Larry Ereshefsky, PharmD, BCPPR, FCCP Clinical Development: Reviva employees and Consultants Drug Monit
Reviva Pharmaceuticals Holdings — Technical Presentation (June 2025) on 6ix