SlideShare a Scribd company logo
1 of 30
Download to read offline
Corporate Presentation March 2022
REVIVA PHARMACEUTICALS HOLDINGS, INC. (NASDAQ: RVPH)
Corporate Presentation, July 2023
Reviva | Corporate Presentation 2
Forward Looking Statements
This presentation contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s
RECOVER Phase 3 trial and timing of topline data, the Company’s expectations regarding the anticipated clinical profile of its product candidates,
including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs
regarding matters including product development and clinical trial plans, clinical and regulatory timelines, trial results, market opportunity,
competitive position, possible or assumed future results of operations, business strategies, potential growth and financing opportunities and other
statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections
about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the
use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict,"
"project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s
financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the COVID19
pandemic and the potential impact of sustained social distancing efforts, on the Company’s operations, clinical development and clinical trial plans
and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual
Report on Form 10-K for the fiscal year ended December 31, 2022, and the Company’s other filings from time to time with the Securities and
Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as
of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.
Reviva | Corporate Presentation 3
Key Business Highlights
IL-18; Interleukin-18.
Late-stage pharmaceutical
company developing new
therapies for central nervous
system, inflammatory, and
cardiometabolic diseases
Chemical genomics driven
discovery approach
Strong patent portfolio
Company
Overview
Differentiated pharmacology profile
as modulator of serotonin and
dopamine signaling pathways
Prioritizing ongoing pivotal Phase 3
trial in schizophrenia with topline
data anticipated in Q3 2023
Potential for clinical expansion in
additional neuropsychiatric and
inflammatory diseases
Lead Asset:
Brilaroxazine
Global addressable market size for
brilaroxazine:
$10.1 B for schizophrenia by 20281
$6.2 B for bipolar disorder by 20272
$24.5 B for MDD by 20303
$29.3 B for ADHD by 20284
$51.2 B for psoriasis by 20305
$11.0 B for PAH by 20306
$6.2 B for IPF by 20307
Market
Opportunity
3. MDD: Research and Markets.Com, 2021
4. ADHD: Verified Market Research, 2022
7. IPF: Allied Market Research, 2022
1.Schizophrenia: Verified Market Research 2021
2.Bipolar Disorder: Maximize Market Research 2021
5. Psoriasis: Precedence Research 2022
6. PAH: Grand View Research, 2022
Reviva | Corporate Presentation 4
Program Prioritized Target Indications*
Development Phase
Discovery Preclinical Phase I Phase II Phase III
Brilaroxazine –
Serotonin/ dopamine
modulator (NCE))
Neuropsychiatric
Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Attention Deficit Hyperactivity Disorder
Inflammatory
Pulmonary Arterial Hypertension
Idiopathic Pulmonary Fibrosis
Psoriasis (topical gel)
RP1208 –
Triple reuptake
inhibitor (NCE)
Depression
Obesity
Extensive Clinical Development Pipeline
*Opportunity to expand into other indications including Parkinson’s Psychosis and Alzheimer’s (Psychosis/agitation)
Ongoing
Reviva | Corporate Presentation 5
Dysfunctional Serotonin or Dopamine Signaling is Implicated in the
Pathobiology of Psychiatric Disorders and Inflammatory Diseases
Bhat L. et al. Med Res Arch 2023, 1194):3834; Martel JC et al. Front Pharmacol 2020, 11:1003; Ferre S et al. Front Endocrinol 2022, 13:1014678; Oades RD. Expert Rev
Neurotherapeutics 2007, 7:1357; Edinoff AN et al. Front Psych 2021, 12:789982; Lee J et al. Molecules 2021, 26:3348; Bhat L et al. Eur J Pharmacol 2018, 827:159; Bhat L et al.
Med Res Arch 2023, 11(4):3837; Channer B et al. Pharmacol Rev 2023, 75:62; Wan M et al. Front Immun 2020, 11:186; Wardhana M et al. OAM J Med Sci 2019, 7(7):1138.
Positive Symptoms
Negative Symptoms
Cognitive Symptoms
Depressive Symptoms
ADHD Symptoms
5-HT1A 5-HT2A 5-HT7
5-HT2B 5-HT7
Vasoconstriction
Fibrosis and Inflammation
Thrombosis
5-HT2B
Immune Dysfunction
Inflammation and Fibrosis
Neuropsychiatric diseases are associated with dysfunctional serotonin and
dopamine signaling and dysregulated immune responses
Serotonin signaling is implicated in inflammatory diseases
including PAH, IPF and psoriasis
D2 D3
D4
D4
5-HT1A 5-HT2A 5-HT7
D4
5-HT1A 5-HT2A
D2 D4
D4 5-HT1A 5-HT2B 5-HT7
5-HT2A 5-HT2B
5-HT2A 5-HT7
5-HT2B
5-HT2A 5-HT7
D2 D4
Dopamine receptors Serotonin receptors
Neuropsychiatric Disorders Pulmonary Diseases (PAH and IPF)
Psoriasis
5-HT2A
Reviva | Corporate Presentation 6
Neuropsychiatric Indications Inflammatory Indications
Schizophrenia
Major Depressive
Disorder
Bipolar Disorder ADHD Psoriasis
Pulmonary Arterial
Hypertension (PAH)
Idiopathic Pulmonary
Fibrosis (IPF)
$10.1B
by 20281
$24.5B
by 20303
$6.2B
by 20272
$29.3B
by 20284
$51.2B
by 20305
$11.0B
by 20306
$6.2B
by 20307
3. MDD: Research and Markets.Com, 2021
4. ADHD: Verified Market Research, 2022
7. IPF: Allied Market Research, 2022
Potential Market Opportunity for Brilaroxazine
Addressing Significant Unmet Medical Needs: Psychiatric Conditions and Immune System Abnormalities
1.Schizophrenia: Verified Market Research 2021
2.Bipolar Disorder: Maximize Market Research 2021
5. Psoriasis: Precedence Research 2022
6. PAH: Grand View Research, 2022
Neuropsychiatric Programs
Schizophrenia | Bipolar Disorder |
Major Depressive Disorder | ADHD
Reviva | Corporate Presentation 8
Schizophrenia affects ~1.1% of the world’s
population and ~3.5 million people in the
US1 and ~24 million globally2
Need for therapies that adequately address the
complex mix of positive & negative symptoms,
mood, and associated cognitive impairment3
Not all symptoms addressed
• Negative symptoms
• Cognitive deficits
• Mood symptoms
• Inflammation / Immune System
Abnormalities
Suboptimal
Efficacy4,5,6,8
Poor Tolerability/Side Effects
• Neurological (EPS, akathisia)
• Endocrine (hormones
imbalance, sexual dysfunction)
• Metabolic (obesity, diabetes,
cholesterol)
Estimated discontinuation rates
• 30-50% in short-term treatment
of acute patients
• 42-74% in long-term treatment of
stable patients
Poor Tolerability/
Side Effects5
High Discontinuation/
Non-Compliance6,7
5. Stroup T S and Gray N, World Psychiatry 2018, 17:341-356.
6. Bhat L et al, J Neurology and Neuromedicine 2018, 3(5): 39-50.
7. Levin, S.Z. et al., Schizophrenia Research 2015, 164:122-126
8. Ermakov EA. et al., Frontiers in neuroscience 2022, 13:880568
1. Mentalhealth.net American Addiction Centers Resource, https://www.mentalhelp.net (March 18, 2022)
2. https://www.who.int/news-room/fact-sheets/detail/schizophrenia (March 18, 2022)
3. Mentalhealth.net American Addiction Centers Resource, https://www.mentalhelp.net/schizophrenia/statistics/ (April 24, 2021)
4. Torres-Gonzalez F et al, Neuropsychiatric Disease and Treatment 2014, 10:97-110.
Schizophrenia Prevalence and Unmet Needs
No current therapies address all needs of patients
Reviva | Corporate Presentation 9
Targeting serotonin and dopamine receptors can treat schizophrenia and comorbid symptoms
Glutamate, GABA,
muscarinic and
nicotinic receptors
are downstream
targets which are
affected by
dysfunctional
dopamine and
serotonin
signaling system
DA and 5-HT drive pathobiology and symptom domains
in schizophrenia, bipolar disorder, major depressive
disorder, and attention/deficit hyperactivity disorder
Many Psychiatric Disorders are Primarily Driven by Dysfunctional Serotonin
and Dopamine Signaling
Positive
symptoms
Cognitive
deficits
Mood
Agitation
Negative
symptoms
5-HT1A, 5-HT2A,
5-HT2B, 5-HT7
D2, D3, D4
5-HT1A, 5-HT2A,
5-HT2B, D4
D1, D2, D4,
5-HT2A, 5-HT2B, 5-HT7
5-HT1A, 5-HT2A,
5-HT2B, 5-HT7
Glutamate GABA
Dopamine
Serotonin
Muscarinic
Receptors
Nicotinic
Receptors
Bhat L, et al. Medical Research Archives 2023, 11(4):3834
Reviva | Corporate Presentation 10
Bhat L, et al. Medical Research Archives 2023, 11(4):3834 ; Reale M et al. Frontiers in Psychiatry 2021, 12:536257; Monji A et al. Japanese Society of Psychiatry and Neurology 2009, 63:257-265.
Imbalance of Cytokines in Schizophrenia: Putative Treatment Targets
Cytokines mediate cross-talk between the nervous system and the inflammatory response
IL-1β and IL-6
Schizophrenia
IL-1β, IL-4, IL-6, INF-γ, TNF-α, and TGF-β
IL-1β, and IL-6
IL-1β, IL-6 and TNF-α
IL-6, IL-17, and TGF-β
More severe positive symptoms
Exacerbated negative symptoms
Worse cognitive abilities
Mood symptoms
Increased PANSS score
Reviva | Corporate Presentation 11
Brilaroxazine
(RP5063)
Brilaroxazine: Target Engagement and Multifaceted Mechanism of Action
Targeting serotonin and dopamine receptors can treat schizophrenia and comorbid symptoms
Bhat L, et al. Medical Research Archives 2023, 11(4):3834; Rajagopal et al, Behavioral Brain Research 2017, 332;180-199
Direct
modulation
Dopamine receptors (D2/3/4)
Upstream targets
Downstream targets
Serotonin receptors (5-HT1A/2A/2B/7)
Inflammatory cytokines (TNF-α, TGF-β, IFN-γ, IL-1β, IL-6, IL-17)
Nicotinic receptors
NMDA/Glycine receptors
GABA receptors
Indirect modulation
Positive
symptoms
Cognitive
deficits
Mood
Agitation
Negative
symptoms
5-HT1A, 5-HT2A, 5-
HT2B, 5-HT7
D2, D3, D4
5-HT1A, 5-HT2A, 5-
HT2B, D4
D1, D2, D4,
5-HT2A, 5-HT2B, 5-HT7
5-HT1A, 5-HT2A,
5-HT2B, 5-HT7
Treatment
Effect
Reviva | Corporate Presentation 12
Brilaroxazine Has a Differentiated Target Receptor Activity Profile
(1) Bhat L, et al. Medical Research Archives 2023, 11(4):3834. (2) Bhat, et al. European J Pharmacology 2017, 810:83-91 and 92-99.
Positive
Symptoms
Negative
Symptoms
Mood
Symptoms
Cognitive
Dysfunction
Brilaroxazine reduced proinflammatory cytokines and
chemokines implicated in major symptom domains of
schizophrenia in animal models1,2
Brilaroxazine Receptor Binding Affinities for
Schizophrenia Symptoms1
High (Ki, nM)*
Dopamine D2
Dopamine D3
Dopamine D4
0.4
3.7
6
Serotonin 5-HT1A
Serotonin 5-HT2A
Serotonin 5-HT2B
Serotonin 5-HT7
1.5
2.5
0.19
2.7
Moderate (Ki, nM)
Nicotine α4β2
Serotonin 5-HT6
36.3
51
Weak or no
significant activity
No significant activities at therapeutic
dose for off-targets 5-HT2C, α1,2, and
M1-4 implicated in cardiometabolic,
metabolic, and GI side effects
• IL-1β
• IL-6
• IL-1β, IL-6
• TNF-α
• TGF-β
• INF-γ
• IL-1β
• IL-6
• IL-1β
• IL-6
• TNF-α
*partial agonists for D2,3,4 and 5-HT1A receptors
Reviva | Corporate Presentation 13
Schizophrenia Phase 2 Study: Significant Treatment Difference from Placebo
Brilaroxazine demonstrated improved PANSS total score across all dose levels (N=234)
(1) Bhat, et al. J Neurol Neuromed 2018, 3(5): 39-50. (2) Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133
* *
*
*
*
* *
* p<0.05
• Study met the safety and
efficacy endpoints
• Statistically significant,
sustained treatment effect
with decrease in PANSS
scores
• Treatment effects started
separating from placebo
within a week
Efficacy Data for
Schizophrenia
PANSS Total Score (Primary Endpoint)
Reviva | Corporate Presentation 14
Brilaroxazine Mitigated Positive and Negative Symptoms
Phase 2 Study in Schizophrenia
*
*
*
*
*
*
*
*
*
*
*
* *
*
*
Decrease in Positive Symptoms Decrease in Negative Symptoms
*
Bhat et al. J Neurology & Neuromedicine 2018, 3(5): 39-50 ; Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133
* p<0.05, ** p<0.01, *** p<0.001
Reviva | Corporate Presentation 15
Brilaroxazine Improved Social Functioning and Cognition
Phase 2 Study in Schizophrenia
* p<0.05, ** p<0.01, *** p<0.001
Improvement in Cognition
*
*
Bhat et al. J Neurology & Neuromedicine 2018, 3(5): 39-50 ; Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133
*
* * *
*
* *
*
*
* * *
Improvement in Social Functioning
Reviva | Corporate Presentation 16
Schizophrenia Phase 2 Study: Brilaroxazine Side Effect Profile
Neuroleptic, Endocrine and Metabolic Side Effects of Brilaroxazine Comparable to Placebo (N=234)
(1) Bhat, et al. J Neurol Neuromed 2018, 3(5): 39-50. (2) Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133
Ari: Aripiprazole; RP: Brilaroxazine (RP5063)
RP: 15mg projected, widely used dose
Extrapyramidal Side Effect (%) Change in Prolactin (mIU/L)
Akathisia (%) Change in Thyroid-T4 (pmol/L)
Body Weight Increase (%) Diabetes/Blood Sugar (mmol/L) Lipids/Triglycerides (mmol/L)
Cholesterol (mmol/L)
CNS / Neuroleptic Side Effects Endocrine Side Effects
Metabolic Side Effects
Reviva | Corporate Presentation 17
DDIs and polypharmacy alter plasma drug concentrations,
and can impact efficacy and side effect profiles of a drug11
(1) Bhat L et al, ASPET 2023 (poster #376); (2) Aripiprazole (Abilify) NDA document, 2001; (3) Mahatthanatrakul et al, J Clin Pharm Thera 2007, 32(2):161-167 ; (4) Brexpiprazole
(Rexulti) NDA document, 2014; (5) Lumetaperone (Caplyta) NDA document, 2018; (6) Cariprazine (Vraylar) NDA document 2014; (7) Pharmaceuticals 2020; (8) Quetiapine (Seroquel);
Grim et al., Brit J Clin Pharm 2005, 61(1):58-69; (9) Olanzapine NDA document; (10) Vilckova et al., Onco Lett 2023, 25:85; (11) Bole B et al, Medicina 2023, 59:284. NR: not reported
~50% of prescribed drugs and over 25% of approved antipsychotics are known
to cause drug interactions in the presence of a strong CYP3A4 inhibitor drug
Lower Clinical Drug-Drug Interactions (DDIs) with Brilaroxazine vs Standards of Care
Up to 34x higher drug plasma concentration with standard of care antipsychotics over brilaroxazine in presence of a strong
CYP3A4 inhibitor: A Clinical Differentiation Factor
*Olanzapine9 not evaluated; metabolized by CYP1A210
Change in drug concentration with a
CYP3A4 Inhibitor
Antipsychotic
Fold increase vs
brilaroxazine
Brilaroxazine --
Aripiprazole 4.2x
Risperidone 4.5x
Brexpiprazole 6.5x
Lumetaperone 16.2x
Cariprazine 19.2x
Lurasidone 34.7x
Quetiapine 34.8x
with a CYP3A4 Inhibitor
15%
63%
67%
97%
243%
288%
520%
522%
Brilaroxazine
Aripiprazole
Risperidone
Brexpiprazole
Lumetaperone
Cariprazine
Lurasidone
Quetiapine
with a CYP3A4 Inducer
% Increase in drug concentration (AUC) % Decrease in drug concentration (AUC)
(Lower is better)
54%
61%
72%
73%
98%
NR
82%
87%
Brilaroxazine
Aripiprazole
Risperidone
Brexpiprazole
Lumetaperone
Cariprazine
Lurasidone
Quetiapine
Reviva | Corporate Presentation 18
Brilaroxazine Phase 3 RECOVER Trial For Schizophrenia (ongoing)
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
For details see: www.clinicaltrials.gov (search key word, RP5063)
Primary Endpoint (DBS):
Reduction in total PANSS at the
end of treatment in a
brilaroxazine arm from baseline
versus placebo
Safety (DBS, OLS):
Clinical, labs, body weight, lipids,
fasting glucose, prolactin
Pharmacokinetics:
Population pharmacokinetics
Study Overview
Schizophrenia
Acute Patients
-------
Randomized
3 Groups
1:1:1
Brilaroxazine,
50mg
Brilaroxazine,
15mg
Placebo
N = 134
Schizophrenia
Stable Patients
–––––––
Opel Label Treatment
1-Group (N = ~400)
Brilaroxazine, 15 – 50mg
Flexible Dose
DBS
N = ~200
DBT
Rollover
New
Patients
Part 1:
Double-blind Study (DBS)
28 Days
1-Week follow up and stabilization for patients
discontinue treatment or not rolling over to OLS
Part 2:
Open Label Study (OLS)
52 Weeks
1-Week follow up and stabilization for patients
discontinue or complete the OLS
N = ~400
N = 402
OLS
N = 134
N = 134
N = ~200
Reviva | Corporate Presentation 19
Current Positioning of Brilaroxazine (RP5063) vs. Major Antipsychotics
Meta-Analysis of Clinical Data of Antipsychotics
Brilaroxazine
Side Effects
(Lower is Better)
Efficacy
(Higher is Better)
Reviva Sponsored Research from Zacks SC Research, April 2021; Lancet 2019, 394:939-951.
Current data suggests
that brilaroxazine may
have a favorable efficacy
and side effect profile vs.
currently approved
antipsychotics
Inflammatory / Immune Disease Programs
Psoriasis  Pulmonary Arterial Hypertension (PAH) |
Idiopathic Pulmonary Fibrosis (IPF)
Reviva | Corporate Presentation 21
Brilaroxazine has Potential to Treat Psoriasis
Inflammatory skin disease driven by dysfunctional serotonin-dopamine signaling
• Approx 3% of the US population and an estimated 125
million people worldwide suffer from psoriasis
• An estimated one-third of neuropsychiatric and
neurodegenerative disease patients suffer from psoriasis
• Currently there is no cure for psoriasis
− Topical corticosteroids therapies remain the cornerstone for
treating mild psoriasis
− Biologics that inhibit cytokines TNF-α, p40IL-12/13, IL-17, and
p19Il-23, and oral PDE-4 inhibitor for moderate to severe
plaque psoriasis
Armstrong AW. Pathobiology, clinical presentation, and Treatment of psoriasis, JAMA 2020, 323(19):1945-1960; Bhat L, et al. ISID 2023, Poster #LB1745; www.revivapharma.com/ISID-2023-Poster
Reviva | Corporate Presentation 22
Brilaroxazine Demonstrated Encouraging Preclinical Efficacy
In an imiquimod induced mouse model of psoriasis
Bhat L, et al. ISID 2023, Poster #LB1745 (https://revivapharma.com/wp-content/uploads/2023/05/RS-Reviva-ISID-2023-Poster.pdf)
P = 0.03
Psoriasis Area Severity Index (PASI) Psoriasis Severity by Baker Score
Decrease in anti-inflammatory and
proliferation cytokine (KI67) and
profibrotic chemokine (TGF-β)
Brilaroxazine topical
liposomal gel
significantly decreased
• Psoriasis area severity index (P= 0.03)
• Clinical severity of psoriasis, Baker score (p=0.003)
• Proinflammatory and proliferation cytokine, KI67 (P=0.001)
• Profibrotic chemokine, TGF-β (P=0.001)
Reviva | Corporate Presentation 23
Brilaroxazine: Potential to Delay PAH and IPF Disease Progression
PAH and IPF are Orphan Diseases that involve dysfunctional serotonin signaling
© 2018 Mayo Clinic
5-HT7
5-HT2B
5-HT2A
Lung
Irregular, abnormal air spaces
Large areas of scarring (fibrosis)
Irregular thickening of tissue
between alveoli
Normal
alveoli
Lung
Lung Vascular Remodeling in PAH
• PAH and IPF are rare, chronic, and debilitating conditions
• No therapies significantly delay disease progression
• Patients experience elevated plasma serotonin (5-HT) levels,
increased expression of 5-HT2A/2B/7 receptors & inflammatory
cytokines in lungs
Lung Alveoli Remodeling in IPF
• Lung vascular/alveoli remodeling occurs due to inflammation,
fibrosis, and pulmonary hypertension
• Brilaroxazine has robust antagonism against serotonin receptors
involved in vasoconstriction, fibrosis, blood clots, and inflammation
Bhat L, et al. Medical Research Archives 2023, 11(4):3837; Bhat et al., Eur J Pharmacol 2018, 827:159-166; Lofdahl et al, Am J Pathobiology 2018, 188(5): 1113-1119;
Tawfik and Makary, European J Pharmacology 2017, 814: 114-123; Pulmonary fibrosis image adapted from https://tinyurl.com/y9r6ld48
Reviva | Corporate Presentation 24
Brilaroxazine: Encouraging Results in PAH Translational Rodent Models
Potential for Improved Treatment Effect Compared to Standard of Care
• Mitigated PAH in MCT and Sugen-Hypoxia
rodent models
• Decreased respiratory resistance and restored
blood oxygen saturation
• Decreased vascular remodeling and fibrosis in
the small vessels
• Mitigated inflammation & reduced small vessel
thickness
• Significantly reduced inflammatory cytokines
TNFα, IL-β, IL-6, and chemokine LTB4
Brilaroxazine alone and co-administered with
standard of care for PAH
Brilaroxazine mitigates pulmonary
hypertension and lung fibrosis/collagen
Bhat and Salvail, J Rare Dis Res Treat 2017, 2(5): 5-12.  Bhat, et al. European J Pharmacology 2017, 810:83-91 and 92-99.
Bhat, et al. European J Pharmacology 2018, 827: 159-166.
Reviva | Corporate Presentation 25
Brilaroxazine: Encouraging Results in Bleomycin-Induced IPF Rodent Model
Potential for Improved Treatment Effect Compared to Standard of Care
• Mitigated lung fibrosis and collagen deposits
• Decreased respiratory resistance & improved
blood oxygen saturation
• Restored body weight and cardiac output
• Reduced the IPF biomarkers BALF cell counts,
hydroxyproline, and blood lactate levels
• Decreased cytokines RANTES, IFNγ, MCP1,
IL-6, and IL-17
• Improved survival rates
Brilaroxazine both alone and co-administered
with standard of care for IPF
Brilaroxazine mitigates lung fibrosis / collagen
(Decrease in Hydroxyproline)
Bhat L, et al. Medical Research Archives 2023, 11(4):3837
Reviva | Corporate Presentation 26
Brilaroxazine Improves Survival in Bleomycin Induced IPF Rodent Model
Significant Treatment Effect and Functional Outcomes
Brilaroxazine Mitigates Respiratory Resistance Brilaroxazine Improves Survival
Bhat L, et al. Medical Research Archives 2023, 11(4):3837
Reviva | Corporate Presentation 27
Brilaroxazine: Ready for Phase 2 Trials in PAH and IPF
FDA granted Orphan Drug Designation
• Preclinical evidence supports the use of Brilaroxazine in PAH and IPF
• Generally well-tolerated in clinical studies for schizophrenia in >250 patients
• Completed long-term regulatory toxicology studies
• Manufactured API and drug products (clinical trial materials)
• Oral once daily dosing, potential to develop once daily inhaler for enhanced effect and convenience
Brilaroxazine Phase 2 trials in PAH and IPF
Key regulatory milestones achieved
• FDA reviewed preclinical pharmacology, toxicology, CMC, and clinical Phase 1 safety data for initiating a Phase 2 study
• FDA reviewed and provided guidance on Phase 2/3 clinical development plan and a potential “Disease Modifying Agent”
label claim
• FDA granted Orphan Drug Designation for the treatment of PAH and IPF
Reviva | Corporate Presentation 28
Laxminarayan Bhat, PhD
Founder, President and CEO
Narayan Prabhu, CPA
Chief Financial Officer
Harald Murck, MD
Sr VP Clinical Development
Sangita Ghosh, PhD
Sr VP Pharm Development
Seema Bhat, MS, CTDM, PMP
VP Program & Portfolio
Kevin Charrier
VP Quality Assurance
Experienced Management Team
20+ years of experience in drug discovery and clinical development
Reviva | Corporate Presentation 29
Pipeline-in-a-Product Opportunities for Lead Asset Brilaroxazine
IL-18; Interleukin-18.
Differentiated pharmacology
profile as modulator of
serotonin and dopamine
signaling pathways implicated
in neuropsychiatric and
inflammatory diseases
Multifaceted Activity
for Brilaroxazine
Ongoing pivotal Phase 3
trial in schizophrenia with
expansion potential in
neuropsychiatric disorders
and inflammatory diseases
Late-Stage Clinical
Development
Near-term Catalysts
Topline data for pivotal
Phase 3 trial in schizophrenia
expected in Q3 2023
Cupertino,
CA
Bangalore,
India
Investor Relations Contact
IR@Revivapharma.com
info@Revivapharma.com
General Inquiries
Reviva Pharmaceuticals Holdings, Inc.
International Offices
Bangalore, India
U.S. Headquarters
Cupertino, CA, USA
Global Operations
Business Inquiries
busdev.rp@Revivapharma.com

More Related Content

Similar to RVPH Presentation

Similar to RVPH Presentation (20)

First quarter 2023 results
First quarter 2023 resultsFirst quarter 2023 results
First quarter 2023 results
 
Q1 2023 results highlights
Q1 2023 results highlightsQ1 2023 results highlights
Q1 2023 results highlights
 
2018/01 – JP Morgan Healthcare Conference
2018/01 – JP Morgan Healthcare Conference2018/01 – JP Morgan Healthcare Conference
2018/01 – JP Morgan Healthcare Conference
 
Peptide Therapeutics Market, 2021-2030 (Free Insights).pptx
Peptide Therapeutics Market, 2021-2030 (Free Insights).pptxPeptide Therapeutics Market, 2021-2030 (Free Insights).pptx
Peptide Therapeutics Market, 2021-2030 (Free Insights).pptx
 
2015/07 – IR – Praluent
2015/07 – IR – Praluent2015/07 – IR – Praluent
2015/07 – IR – Praluent
 
Chronic Bronchitis Market 2023: Epidemiology, Industry Trends, Size, Share An...
Chronic Bronchitis Market 2023: Epidemiology, Industry Trends, Size, Share An...Chronic Bronchitis Market 2023: Epidemiology, Industry Trends, Size, Share An...
Chronic Bronchitis Market 2023: Epidemiology, Industry Trends, Size, Share An...
 
Virios Therapeutics Presentation Q3 2021
Virios Therapeutics Presentation Q3 2021Virios Therapeutics Presentation Q3 2021
Virios Therapeutics Presentation Q3 2021
 
Bronchopulmonary Dysplasia Market 2023: Epidemiology, Industry Trends, Size, ...
Bronchopulmonary Dysplasia Market 2023: Epidemiology, Industry Trends, Size, ...Bronchopulmonary Dysplasia Market 2023: Epidemiology, Industry Trends, Size, ...
Bronchopulmonary Dysplasia Market 2023: Epidemiology, Industry Trends, Size, ...
 
Ventrus Bio Investor Presentation - May 2011
Ventrus Bio Investor Presentation - May 2011Ventrus Bio Investor Presentation - May 2011
Ventrus Bio Investor Presentation - May 2011
 
Ventrus presentation to investors
Ventrus presentation to investorsVentrus presentation to investors
Ventrus presentation to investors
 
Sustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentation
 
Virios Therapeutics Presentation
Virios Therapeutics PresentationVirios Therapeutics Presentation
Virios Therapeutics Presentation
 
SNGX Presentation
SNGX PresentationSNGX Presentation
SNGX Presentation
 
Virios Therapeutics Presentation Q4 2021
Virios Therapeutics Presentation Q4 2021Virios Therapeutics Presentation Q4 2021
Virios Therapeutics Presentation Q4 2021
 
Virios Therapeutics Investor Deck March 2021
Virios Therapeutics Investor Deck March 2021Virios Therapeutics Investor Deck March 2021
Virios Therapeutics Investor Deck March 2021
 
Virios Therapeutics Investor 2021
Virios Therapeutics Investor 2021Virios Therapeutics Investor 2021
Virios Therapeutics Investor 2021
 
Progenity (PROG) Investor Presentation - Nov 30, 2021
Progenity (PROG) Investor Presentation - Nov 30, 2021Progenity (PROG) Investor Presentation - Nov 30, 2021
Progenity (PROG) Investor Presentation - Nov 30, 2021
 
CanniMed Therapeutics Inc. Investor Deck February 2017
CanniMed Therapeutics Inc. Investor Deck February 2017CanniMed Therapeutics Inc. Investor Deck February 2017
CanniMed Therapeutics Inc. Investor Deck February 2017
 
LTRN Investor Presentation
LTRN Investor PresentationLTRN Investor Presentation
LTRN Investor Presentation
 
2018/09 – BoA-ML HC Conference
2018/09 – BoA-ML HC Conference2018/09 – BoA-ML HC Conference
2018/09 – BoA-ML HC Conference
 

More from RedChip Companies, Inc.

SPI Investor Deck October 2023
SPI Investor Deck October 2023SPI Investor Deck October 2023
SPI Investor Deck October 2023
RedChip Companies, Inc.
 

More from RedChip Companies, Inc. (20)

ZOM Investor Presentations Oct 2023
ZOM Investor Presentations Oct 2023ZOM Investor Presentations Oct 2023
ZOM Investor Presentations Oct 2023
 
Docola Presentation
Docola PresentationDocola Presentation
Docola Presentation
 
INNO Holdings Presentation
INNO Holdings PresentationINNO Holdings Presentation
INNO Holdings Presentation
 
EBI IR Presentation Sep 2023
EBI IR Presentation Sep 2023EBI IR Presentation Sep 2023
EBI IR Presentation Sep 2023
 
ASPI Investor Deck Oct 2023
ASPI Investor Deck Oct 2023ASPI Investor Deck Oct 2023
ASPI Investor Deck Oct 2023
 
MDNA Investor Presentation May 2023
MDNA Investor Presentation May 2023MDNA Investor Presentation May 2023
MDNA Investor Presentation May 2023
 
DGLY Corporate Investor Relations Deck Oct 2023
DGLY Corporate Investor Relations Deck Oct 2023DGLY Corporate Investor Relations Deck Oct 2023
DGLY Corporate Investor Relations Deck Oct 2023
 
Lantern Pharma Investor Presentation Oct 2023
Lantern Pharma Investor Presentation Oct 2023Lantern Pharma Investor Presentation Oct 2023
Lantern Pharma Investor Presentation Oct 2023
 
Sharps Investor Deck Oct 2023
Sharps Investor Deck Oct 2023 Sharps Investor Deck Oct 2023
Sharps Investor Deck Oct 2023
 
Aditxt, Inc. (NASDAQ: ADTX) Presentation
Aditxt, Inc. (NASDAQ: ADTX) PresentationAditxt, Inc. (NASDAQ: ADTX) Presentation
Aditxt, Inc. (NASDAQ: ADTX) Presentation
 
1847 Holdings Corporate Presentation 1847 Holdings March 2023
1847 Holdings Corporate Presentation 1847 Holdings March 20231847 Holdings Corporate Presentation 1847 Holdings March 2023
1847 Holdings Corporate Presentation 1847 Holdings March 2023
 
Sharps Investor Presentation October 2023
Sharps  Investor Presentation October 2023Sharps  Investor Presentation October 2023
Sharps Investor Presentation October 2023
 
SPI Investor Deck October 2023
SPI Investor Deck October 2023SPI Investor Deck October 2023
SPI Investor Deck October 2023
 
BFRG Investor Deck September_v2
BFRG Investor Deck September_v2BFRG Investor Deck September_v2
BFRG Investor Deck September_v2
 
BFRG Investor Deck September
BFRG Investor Deck SeptemberBFRG Investor Deck September
BFRG Investor Deck September
 
BioVie Presentation September 2023
BioVie Presentation September 2023BioVie Presentation September 2023
BioVie Presentation September 2023
 
Lantern Pharma September 8, 2023
Lantern Pharma September 8, 2023Lantern Pharma September 8, 2023
Lantern Pharma September 8, 2023
 
GENE Investor Presentation Genetic Technologies August 2023
GENE Investor Presentation Genetic Technologies August 2023GENE Investor Presentation Genetic Technologies August 2023
GENE Investor Presentation Genetic Technologies August 2023
 
Splash Beverage Investor Presentation June 2023
Splash Beverage Investor Presentation June 2023Splash Beverage Investor Presentation June 2023
Splash Beverage Investor Presentation June 2023
 
SEBV Presentation
SEBV PresentationSEBV Presentation
SEBV Presentation
 

Recently uploaded

Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Call Girls In Delhi Whatsup 9873940964 Enjoy Unlimited Pleasure
 
Rohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Rohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No AdvanceRohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Rohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Call Girls In Delhi Whatsup 9873940964 Enjoy Unlimited Pleasure
 
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts PodanurTop Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
dharasingh5698
 
B2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccB2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxccccccccccccccc
MollyBrown86
 
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
mriyagarg453
 
VIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our Escorts
VIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our EscortsVIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our Escorts
VIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our Escorts
sonatiwari757
 
VIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our Escorts
VIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our EscortsVIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our Escorts
VIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our Escorts
sonatiwari757
 
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableCall Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Sheetaleventcompany
 

Recently uploaded (20)

Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
 
@9999965857 🫦 Sexy Desi Call Girls Janakpuri 💓 High Profile Escorts Delhi 🫶
@9999965857 🫦 Sexy Desi Call Girls Janakpuri 💓 High Profile Escorts Delhi 🫶@9999965857 🫦 Sexy Desi Call Girls Janakpuri 💓 High Profile Escorts Delhi 🫶
@9999965857 🫦 Sexy Desi Call Girls Janakpuri 💓 High Profile Escorts Delhi 🫶
 
Best investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice DiscountingBest investment platform in india-Falcon Invoice Discounting
Best investment platform in india-Falcon Invoice Discounting
 
Call Girls 🫤 East Of Kailash ➡️ 9999965857 ➡️ Delhi 🫦 Russian Escorts FULL ...
Call Girls 🫤 East Of Kailash ➡️ 9999965857  ➡️ Delhi 🫦  Russian Escorts FULL ...Call Girls 🫤 East Of Kailash ➡️ 9999965857  ➡️ Delhi 🫦  Russian Escorts FULL ...
Call Girls 🫤 East Of Kailash ➡️ 9999965857 ➡️ Delhi 🫦 Russian Escorts FULL ...
 
Collective Mining | Corporate Presentation - April 2024
Collective Mining | Corporate Presentation - April 2024Collective Mining | Corporate Presentation - April 2024
Collective Mining | Corporate Presentation - April 2024
 
Rohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Rohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No AdvanceRohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Rohini Sector 15 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
 
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts PodanurTop Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
Top Rated Call Girls In Podanur 📱 {7001035870} VIP Escorts Podanur
 
B2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccB2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxccccccccccccccc
 
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
Ambala Escorts Service ☎️ 6378878445 ( Sakshi Sinha ) High Profile Call Girls...
 
(👉゚9999965857 ゚)👉 VIP Call Girls Greater Noida 👉 Delhi 👈 : 9999 Cash Payment...
(👉゚9999965857 ゚)👉 VIP Call Girls Greater Noida  👉 Delhi 👈 : 9999 Cash Payment...(👉゚9999965857 ゚)👉 VIP Call Girls Greater Noida  👉 Delhi 👈 : 9999 Cash Payment...
(👉゚9999965857 ゚)👉 VIP Call Girls Greater Noida 👉 Delhi 👈 : 9999 Cash Payment...
 
VIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our Escorts
VIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our EscortsVIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our Escorts
VIP Amritsar Call Girl 7001035870 Enjoy Call Girls With Our Escorts
 
VIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our Escorts
VIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our EscortsVIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our Escorts
VIP Call Girl Amritsar 7001035870 Enjoy Call Girls With Our Escorts
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024
 
(👉゚9999965857 ゚)👉 Russian Call Girls Aerocity 👉 Delhi 👈 : 9999 Cash Payment F...
(👉゚9999965857 ゚)👉 Russian Call Girls Aerocity 👉 Delhi 👈 : 9999 Cash Payment F...(👉゚9999965857 ゚)👉 Russian Call Girls Aerocity 👉 Delhi 👈 : 9999 Cash Payment F...
(👉゚9999965857 ゚)👉 Russian Call Girls Aerocity 👉 Delhi 👈 : 9999 Cash Payment F...
 
Call Girls in Friends Colony 9711199171 Delhi Enjoy Call Girls With Our Escorts
Call Girls in Friends Colony 9711199171 Delhi Enjoy Call Girls With Our EscortsCall Girls in Friends Colony 9711199171 Delhi Enjoy Call Girls With Our Escorts
Call Girls in Friends Colony 9711199171 Delhi Enjoy Call Girls With Our Escorts
 
(INDIRA) Call Girl Kashmir Call Now 8617697112 Kashmir Escorts 24x7
(INDIRA) Call Girl Kashmir Call Now 8617697112 Kashmir Escorts 24x7(INDIRA) Call Girl Kashmir Call Now 8617697112 Kashmir Escorts 24x7
(INDIRA) Call Girl Kashmir Call Now 8617697112 Kashmir Escorts 24x7
 
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableCall Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
 
@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶
@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶
@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶
 
Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024
 
BDSM⚡Call Girls in Hari Nagar Delhi >༒8448380779 Escort Service
BDSM⚡Call Girls in Hari Nagar Delhi >༒8448380779 Escort ServiceBDSM⚡Call Girls in Hari Nagar Delhi >༒8448380779 Escort Service
BDSM⚡Call Girls in Hari Nagar Delhi >༒8448380779 Escort Service
 

RVPH Presentation

  • 1. Corporate Presentation March 2022 REVIVA PHARMACEUTICALS HOLDINGS, INC. (NASDAQ: RVPH) Corporate Presentation, July 2023
  • 2. Reviva | Corporate Presentation 2 Forward Looking Statements This presentation contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s RECOVER Phase 3 trial and timing of topline data, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines, trial results, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the COVID19 pandemic and the potential impact of sustained social distancing efforts, on the Company’s operations, clinical development and clinical trial plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
  • 3. Reviva | Corporate Presentation 3 Key Business Highlights IL-18; Interleukin-18. Late-stage pharmaceutical company developing new therapies for central nervous system, inflammatory, and cardiometabolic diseases Chemical genomics driven discovery approach Strong patent portfolio Company Overview Differentiated pharmacology profile as modulator of serotonin and dopamine signaling pathways Prioritizing ongoing pivotal Phase 3 trial in schizophrenia with topline data anticipated in Q3 2023 Potential for clinical expansion in additional neuropsychiatric and inflammatory diseases Lead Asset: Brilaroxazine Global addressable market size for brilaroxazine: $10.1 B for schizophrenia by 20281 $6.2 B for bipolar disorder by 20272 $24.5 B for MDD by 20303 $29.3 B for ADHD by 20284 $51.2 B for psoriasis by 20305 $11.0 B for PAH by 20306 $6.2 B for IPF by 20307 Market Opportunity 3. MDD: Research and Markets.Com, 2021 4. ADHD: Verified Market Research, 2022 7. IPF: Allied Market Research, 2022 1.Schizophrenia: Verified Market Research 2021 2.Bipolar Disorder: Maximize Market Research 2021 5. Psoriasis: Precedence Research 2022 6. PAH: Grand View Research, 2022
  • 4. Reviva | Corporate Presentation 4 Program Prioritized Target Indications* Development Phase Discovery Preclinical Phase I Phase II Phase III Brilaroxazine – Serotonin/ dopamine modulator (NCE)) Neuropsychiatric Schizophrenia Bipolar Disorder Major Depressive Disorder Attention Deficit Hyperactivity Disorder Inflammatory Pulmonary Arterial Hypertension Idiopathic Pulmonary Fibrosis Psoriasis (topical gel) RP1208 – Triple reuptake inhibitor (NCE) Depression Obesity Extensive Clinical Development Pipeline *Opportunity to expand into other indications including Parkinson’s Psychosis and Alzheimer’s (Psychosis/agitation) Ongoing
  • 5. Reviva | Corporate Presentation 5 Dysfunctional Serotonin or Dopamine Signaling is Implicated in the Pathobiology of Psychiatric Disorders and Inflammatory Diseases Bhat L. et al. Med Res Arch 2023, 1194):3834; Martel JC et al. Front Pharmacol 2020, 11:1003; Ferre S et al. Front Endocrinol 2022, 13:1014678; Oades RD. Expert Rev Neurotherapeutics 2007, 7:1357; Edinoff AN et al. Front Psych 2021, 12:789982; Lee J et al. Molecules 2021, 26:3348; Bhat L et al. Eur J Pharmacol 2018, 827:159; Bhat L et al. Med Res Arch 2023, 11(4):3837; Channer B et al. Pharmacol Rev 2023, 75:62; Wan M et al. Front Immun 2020, 11:186; Wardhana M et al. OAM J Med Sci 2019, 7(7):1138. Positive Symptoms Negative Symptoms Cognitive Symptoms Depressive Symptoms ADHD Symptoms 5-HT1A 5-HT2A 5-HT7 5-HT2B 5-HT7 Vasoconstriction Fibrosis and Inflammation Thrombosis 5-HT2B Immune Dysfunction Inflammation and Fibrosis Neuropsychiatric diseases are associated with dysfunctional serotonin and dopamine signaling and dysregulated immune responses Serotonin signaling is implicated in inflammatory diseases including PAH, IPF and psoriasis D2 D3 D4 D4 5-HT1A 5-HT2A 5-HT7 D4 5-HT1A 5-HT2A D2 D4 D4 5-HT1A 5-HT2B 5-HT7 5-HT2A 5-HT2B 5-HT2A 5-HT7 5-HT2B 5-HT2A 5-HT7 D2 D4 Dopamine receptors Serotonin receptors Neuropsychiatric Disorders Pulmonary Diseases (PAH and IPF) Psoriasis 5-HT2A
  • 6. Reviva | Corporate Presentation 6 Neuropsychiatric Indications Inflammatory Indications Schizophrenia Major Depressive Disorder Bipolar Disorder ADHD Psoriasis Pulmonary Arterial Hypertension (PAH) Idiopathic Pulmonary Fibrosis (IPF) $10.1B by 20281 $24.5B by 20303 $6.2B by 20272 $29.3B by 20284 $51.2B by 20305 $11.0B by 20306 $6.2B by 20307 3. MDD: Research and Markets.Com, 2021 4. ADHD: Verified Market Research, 2022 7. IPF: Allied Market Research, 2022 Potential Market Opportunity for Brilaroxazine Addressing Significant Unmet Medical Needs: Psychiatric Conditions and Immune System Abnormalities 1.Schizophrenia: Verified Market Research 2021 2.Bipolar Disorder: Maximize Market Research 2021 5. Psoriasis: Precedence Research 2022 6. PAH: Grand View Research, 2022
  • 7. Neuropsychiatric Programs Schizophrenia | Bipolar Disorder | Major Depressive Disorder | ADHD
  • 8. Reviva | Corporate Presentation 8 Schizophrenia affects ~1.1% of the world’s population and ~3.5 million people in the US1 and ~24 million globally2 Need for therapies that adequately address the complex mix of positive & negative symptoms, mood, and associated cognitive impairment3 Not all symptoms addressed • Negative symptoms • Cognitive deficits • Mood symptoms • Inflammation / Immune System Abnormalities Suboptimal Efficacy4,5,6,8 Poor Tolerability/Side Effects • Neurological (EPS, akathisia) • Endocrine (hormones imbalance, sexual dysfunction) • Metabolic (obesity, diabetes, cholesterol) Estimated discontinuation rates • 30-50% in short-term treatment of acute patients • 42-74% in long-term treatment of stable patients Poor Tolerability/ Side Effects5 High Discontinuation/ Non-Compliance6,7 5. Stroup T S and Gray N, World Psychiatry 2018, 17:341-356. 6. Bhat L et al, J Neurology and Neuromedicine 2018, 3(5): 39-50. 7. Levin, S.Z. et al., Schizophrenia Research 2015, 164:122-126 8. Ermakov EA. et al., Frontiers in neuroscience 2022, 13:880568 1. Mentalhealth.net American Addiction Centers Resource, https://www.mentalhelp.net (March 18, 2022) 2. https://www.who.int/news-room/fact-sheets/detail/schizophrenia (March 18, 2022) 3. Mentalhealth.net American Addiction Centers Resource, https://www.mentalhelp.net/schizophrenia/statistics/ (April 24, 2021) 4. Torres-Gonzalez F et al, Neuropsychiatric Disease and Treatment 2014, 10:97-110. Schizophrenia Prevalence and Unmet Needs No current therapies address all needs of patients
  • 9. Reviva | Corporate Presentation 9 Targeting serotonin and dopamine receptors can treat schizophrenia and comorbid symptoms Glutamate, GABA, muscarinic and nicotinic receptors are downstream targets which are affected by dysfunctional dopamine and serotonin signaling system DA and 5-HT drive pathobiology and symptom domains in schizophrenia, bipolar disorder, major depressive disorder, and attention/deficit hyperactivity disorder Many Psychiatric Disorders are Primarily Driven by Dysfunctional Serotonin and Dopamine Signaling Positive symptoms Cognitive deficits Mood Agitation Negative symptoms 5-HT1A, 5-HT2A, 5-HT2B, 5-HT7 D2, D3, D4 5-HT1A, 5-HT2A, 5-HT2B, D4 D1, D2, D4, 5-HT2A, 5-HT2B, 5-HT7 5-HT1A, 5-HT2A, 5-HT2B, 5-HT7 Glutamate GABA Dopamine Serotonin Muscarinic Receptors Nicotinic Receptors Bhat L, et al. Medical Research Archives 2023, 11(4):3834
  • 10. Reviva | Corporate Presentation 10 Bhat L, et al. Medical Research Archives 2023, 11(4):3834 ; Reale M et al. Frontiers in Psychiatry 2021, 12:536257; Monji A et al. Japanese Society of Psychiatry and Neurology 2009, 63:257-265. Imbalance of Cytokines in Schizophrenia: Putative Treatment Targets Cytokines mediate cross-talk between the nervous system and the inflammatory response IL-1β and IL-6 Schizophrenia IL-1β, IL-4, IL-6, INF-γ, TNF-α, and TGF-β IL-1β, and IL-6 IL-1β, IL-6 and TNF-α IL-6, IL-17, and TGF-β More severe positive symptoms Exacerbated negative symptoms Worse cognitive abilities Mood symptoms Increased PANSS score
  • 11. Reviva | Corporate Presentation 11 Brilaroxazine (RP5063) Brilaroxazine: Target Engagement and Multifaceted Mechanism of Action Targeting serotonin and dopamine receptors can treat schizophrenia and comorbid symptoms Bhat L, et al. Medical Research Archives 2023, 11(4):3834; Rajagopal et al, Behavioral Brain Research 2017, 332;180-199 Direct modulation Dopamine receptors (D2/3/4) Upstream targets Downstream targets Serotonin receptors (5-HT1A/2A/2B/7) Inflammatory cytokines (TNF-α, TGF-β, IFN-γ, IL-1β, IL-6, IL-17) Nicotinic receptors NMDA/Glycine receptors GABA receptors Indirect modulation Positive symptoms Cognitive deficits Mood Agitation Negative symptoms 5-HT1A, 5-HT2A, 5- HT2B, 5-HT7 D2, D3, D4 5-HT1A, 5-HT2A, 5- HT2B, D4 D1, D2, D4, 5-HT2A, 5-HT2B, 5-HT7 5-HT1A, 5-HT2A, 5-HT2B, 5-HT7 Treatment Effect
  • 12. Reviva | Corporate Presentation 12 Brilaroxazine Has a Differentiated Target Receptor Activity Profile (1) Bhat L, et al. Medical Research Archives 2023, 11(4):3834. (2) Bhat, et al. European J Pharmacology 2017, 810:83-91 and 92-99. Positive Symptoms Negative Symptoms Mood Symptoms Cognitive Dysfunction Brilaroxazine reduced proinflammatory cytokines and chemokines implicated in major symptom domains of schizophrenia in animal models1,2 Brilaroxazine Receptor Binding Affinities for Schizophrenia Symptoms1 High (Ki, nM)* Dopamine D2 Dopamine D3 Dopamine D4 0.4 3.7 6 Serotonin 5-HT1A Serotonin 5-HT2A Serotonin 5-HT2B Serotonin 5-HT7 1.5 2.5 0.19 2.7 Moderate (Ki, nM) Nicotine α4β2 Serotonin 5-HT6 36.3 51 Weak or no significant activity No significant activities at therapeutic dose for off-targets 5-HT2C, α1,2, and M1-4 implicated in cardiometabolic, metabolic, and GI side effects • IL-1β • IL-6 • IL-1β, IL-6 • TNF-α • TGF-β • INF-γ • IL-1β • IL-6 • IL-1β • IL-6 • TNF-α *partial agonists for D2,3,4 and 5-HT1A receptors
  • 13. Reviva | Corporate Presentation 13 Schizophrenia Phase 2 Study: Significant Treatment Difference from Placebo Brilaroxazine demonstrated improved PANSS total score across all dose levels (N=234) (1) Bhat, et al. J Neurol Neuromed 2018, 3(5): 39-50. (2) Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133 * * * * * * * * p<0.05 • Study met the safety and efficacy endpoints • Statistically significant, sustained treatment effect with decrease in PANSS scores • Treatment effects started separating from placebo within a week Efficacy Data for Schizophrenia PANSS Total Score (Primary Endpoint)
  • 14. Reviva | Corporate Presentation 14 Brilaroxazine Mitigated Positive and Negative Symptoms Phase 2 Study in Schizophrenia * * * * * * * * * * * * * * * Decrease in Positive Symptoms Decrease in Negative Symptoms * Bhat et al. J Neurology & Neuromedicine 2018, 3(5): 39-50 ; Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133 * p<0.05, ** p<0.01, *** p<0.001
  • 15. Reviva | Corporate Presentation 15 Brilaroxazine Improved Social Functioning and Cognition Phase 2 Study in Schizophrenia * p<0.05, ** p<0.01, *** p<0.001 Improvement in Cognition * * Bhat et al. J Neurology & Neuromedicine 2018, 3(5): 39-50 ; Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133 * * * * * * * * * * * * Improvement in Social Functioning
  • 16. Reviva | Corporate Presentation 16 Schizophrenia Phase 2 Study: Brilaroxazine Side Effect Profile Neuroleptic, Endocrine and Metabolic Side Effects of Brilaroxazine Comparable to Placebo (N=234) (1) Bhat, et al. J Neurol Neuromed 2018, 3(5): 39-50. (2) Cantillon, M. et al. Schizophrenia Research 2017, 189: 126-133 Ari: Aripiprazole; RP: Brilaroxazine (RP5063) RP: 15mg projected, widely used dose Extrapyramidal Side Effect (%) Change in Prolactin (mIU/L) Akathisia (%) Change in Thyroid-T4 (pmol/L) Body Weight Increase (%) Diabetes/Blood Sugar (mmol/L) Lipids/Triglycerides (mmol/L) Cholesterol (mmol/L) CNS / Neuroleptic Side Effects Endocrine Side Effects Metabolic Side Effects
  • 17. Reviva | Corporate Presentation 17 DDIs and polypharmacy alter plasma drug concentrations, and can impact efficacy and side effect profiles of a drug11 (1) Bhat L et al, ASPET 2023 (poster #376); (2) Aripiprazole (Abilify) NDA document, 2001; (3) Mahatthanatrakul et al, J Clin Pharm Thera 2007, 32(2):161-167 ; (4) Brexpiprazole (Rexulti) NDA document, 2014; (5) Lumetaperone (Caplyta) NDA document, 2018; (6) Cariprazine (Vraylar) NDA document 2014; (7) Pharmaceuticals 2020; (8) Quetiapine (Seroquel); Grim et al., Brit J Clin Pharm 2005, 61(1):58-69; (9) Olanzapine NDA document; (10) Vilckova et al., Onco Lett 2023, 25:85; (11) Bole B et al, Medicina 2023, 59:284. NR: not reported ~50% of prescribed drugs and over 25% of approved antipsychotics are known to cause drug interactions in the presence of a strong CYP3A4 inhibitor drug Lower Clinical Drug-Drug Interactions (DDIs) with Brilaroxazine vs Standards of Care Up to 34x higher drug plasma concentration with standard of care antipsychotics over brilaroxazine in presence of a strong CYP3A4 inhibitor: A Clinical Differentiation Factor *Olanzapine9 not evaluated; metabolized by CYP1A210 Change in drug concentration with a CYP3A4 Inhibitor Antipsychotic Fold increase vs brilaroxazine Brilaroxazine -- Aripiprazole 4.2x Risperidone 4.5x Brexpiprazole 6.5x Lumetaperone 16.2x Cariprazine 19.2x Lurasidone 34.7x Quetiapine 34.8x with a CYP3A4 Inhibitor 15% 63% 67% 97% 243% 288% 520% 522% Brilaroxazine Aripiprazole Risperidone Brexpiprazole Lumetaperone Cariprazine Lurasidone Quetiapine with a CYP3A4 Inducer % Increase in drug concentration (AUC) % Decrease in drug concentration (AUC) (Lower is better) 54% 61% 72% 73% 98% NR 82% 87% Brilaroxazine Aripiprazole Risperidone Brexpiprazole Lumetaperone Cariprazine Lurasidone Quetiapine
  • 18. Reviva | Corporate Presentation 18 Brilaroxazine Phase 3 RECOVER Trial For Schizophrenia (ongoing) 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 For details see: www.clinicaltrials.gov (search key word, RP5063) Primary Endpoint (DBS): Reduction in total PANSS at the end of treatment in a brilaroxazine arm from baseline versus placebo Safety (DBS, OLS): Clinical, labs, body weight, lipids, fasting glucose, prolactin Pharmacokinetics: Population pharmacokinetics Study Overview Schizophrenia Acute Patients ------- Randomized 3 Groups 1:1:1 Brilaroxazine, 50mg Brilaroxazine, 15mg Placebo N = 134 Schizophrenia Stable Patients ––––––– Opel Label Treatment 1-Group (N = ~400) Brilaroxazine, 15 – 50mg Flexible Dose DBS N = ~200 DBT Rollover New Patients Part 1: Double-blind Study (DBS) 28 Days 1-Week follow up and stabilization for patients discontinue treatment or not rolling over to OLS Part 2: Open Label Study (OLS) 52 Weeks 1-Week follow up and stabilization for patients discontinue or complete the OLS N = ~400 N = 402 OLS N = 134 N = 134 N = ~200
  • 19. Reviva | Corporate Presentation 19 Current Positioning of Brilaroxazine (RP5063) vs. Major Antipsychotics Meta-Analysis of Clinical Data of Antipsychotics Brilaroxazine Side Effects (Lower is Better) Efficacy (Higher is Better) Reviva Sponsored Research from Zacks SC Research, April 2021; Lancet 2019, 394:939-951. Current data suggests that brilaroxazine may have a favorable efficacy and side effect profile vs. currently approved antipsychotics
  • 20. Inflammatory / Immune Disease Programs Psoriasis  Pulmonary Arterial Hypertension (PAH) | Idiopathic Pulmonary Fibrosis (IPF)
  • 21. Reviva | Corporate Presentation 21 Brilaroxazine has Potential to Treat Psoriasis Inflammatory skin disease driven by dysfunctional serotonin-dopamine signaling • Approx 3% of the US population and an estimated 125 million people worldwide suffer from psoriasis • An estimated one-third of neuropsychiatric and neurodegenerative disease patients suffer from psoriasis • Currently there is no cure for psoriasis − Topical corticosteroids therapies remain the cornerstone for treating mild psoriasis − Biologics that inhibit cytokines TNF-α, p40IL-12/13, IL-17, and p19Il-23, and oral PDE-4 inhibitor for moderate to severe plaque psoriasis Armstrong AW. Pathobiology, clinical presentation, and Treatment of psoriasis, JAMA 2020, 323(19):1945-1960; Bhat L, et al. ISID 2023, Poster #LB1745; www.revivapharma.com/ISID-2023-Poster
  • 22. Reviva | Corporate Presentation 22 Brilaroxazine Demonstrated Encouraging Preclinical Efficacy In an imiquimod induced mouse model of psoriasis Bhat L, et al. ISID 2023, Poster #LB1745 (https://revivapharma.com/wp-content/uploads/2023/05/RS-Reviva-ISID-2023-Poster.pdf) P = 0.03 Psoriasis Area Severity Index (PASI) Psoriasis Severity by Baker Score Decrease in anti-inflammatory and proliferation cytokine (KI67) and profibrotic chemokine (TGF-β) Brilaroxazine topical liposomal gel significantly decreased • Psoriasis area severity index (P= 0.03) • Clinical severity of psoriasis, Baker score (p=0.003) • Proinflammatory and proliferation cytokine, KI67 (P=0.001) • Profibrotic chemokine, TGF-β (P=0.001)
  • 23. Reviva | Corporate Presentation 23 Brilaroxazine: Potential to Delay PAH and IPF Disease Progression PAH and IPF are Orphan Diseases that involve dysfunctional serotonin signaling © 2018 Mayo Clinic 5-HT7 5-HT2B 5-HT2A Lung Irregular, abnormal air spaces Large areas of scarring (fibrosis) Irregular thickening of tissue between alveoli Normal alveoli Lung Lung Vascular Remodeling in PAH • PAH and IPF are rare, chronic, and debilitating conditions • No therapies significantly delay disease progression • Patients experience elevated plasma serotonin (5-HT) levels, increased expression of 5-HT2A/2B/7 receptors & inflammatory cytokines in lungs Lung Alveoli Remodeling in IPF • Lung vascular/alveoli remodeling occurs due to inflammation, fibrosis, and pulmonary hypertension • Brilaroxazine has robust antagonism against serotonin receptors involved in vasoconstriction, fibrosis, blood clots, and inflammation Bhat L, et al. Medical Research Archives 2023, 11(4):3837; Bhat et al., Eur J Pharmacol 2018, 827:159-166; Lofdahl et al, Am J Pathobiology 2018, 188(5): 1113-1119; Tawfik and Makary, European J Pharmacology 2017, 814: 114-123; Pulmonary fibrosis image adapted from https://tinyurl.com/y9r6ld48
  • 24. Reviva | Corporate Presentation 24 Brilaroxazine: Encouraging Results in PAH Translational Rodent Models Potential for Improved Treatment Effect Compared to Standard of Care • Mitigated PAH in MCT and Sugen-Hypoxia rodent models • Decreased respiratory resistance and restored blood oxygen saturation • Decreased vascular remodeling and fibrosis in the small vessels • Mitigated inflammation & reduced small vessel thickness • Significantly reduced inflammatory cytokines TNFα, IL-β, IL-6, and chemokine LTB4 Brilaroxazine alone and co-administered with standard of care for PAH Brilaroxazine mitigates pulmonary hypertension and lung fibrosis/collagen Bhat and Salvail, J Rare Dis Res Treat 2017, 2(5): 5-12.  Bhat, et al. European J Pharmacology 2017, 810:83-91 and 92-99. Bhat, et al. European J Pharmacology 2018, 827: 159-166.
  • 25. Reviva | Corporate Presentation 25 Brilaroxazine: Encouraging Results in Bleomycin-Induced IPF Rodent Model Potential for Improved Treatment Effect Compared to Standard of Care • Mitigated lung fibrosis and collagen deposits • Decreased respiratory resistance & improved blood oxygen saturation • Restored body weight and cardiac output • Reduced the IPF biomarkers BALF cell counts, hydroxyproline, and blood lactate levels • Decreased cytokines RANTES, IFNγ, MCP1, IL-6, and IL-17 • Improved survival rates Brilaroxazine both alone and co-administered with standard of care for IPF Brilaroxazine mitigates lung fibrosis / collagen (Decrease in Hydroxyproline) Bhat L, et al. Medical Research Archives 2023, 11(4):3837
  • 26. Reviva | Corporate Presentation 26 Brilaroxazine Improves Survival in Bleomycin Induced IPF Rodent Model Significant Treatment Effect and Functional Outcomes Brilaroxazine Mitigates Respiratory Resistance Brilaroxazine Improves Survival Bhat L, et al. Medical Research Archives 2023, 11(4):3837
  • 27. Reviva | Corporate Presentation 27 Brilaroxazine: Ready for Phase 2 Trials in PAH and IPF FDA granted Orphan Drug Designation • Preclinical evidence supports the use of Brilaroxazine in PAH and IPF • Generally well-tolerated in clinical studies for schizophrenia in >250 patients • Completed long-term regulatory toxicology studies • Manufactured API and drug products (clinical trial materials) • Oral once daily dosing, potential to develop once daily inhaler for enhanced effect and convenience Brilaroxazine Phase 2 trials in PAH and IPF Key regulatory milestones achieved • FDA reviewed preclinical pharmacology, toxicology, CMC, and clinical Phase 1 safety data for initiating a Phase 2 study • FDA reviewed and provided guidance on Phase 2/3 clinical development plan and a potential “Disease Modifying Agent” label claim • FDA granted Orphan Drug Designation for the treatment of PAH and IPF
  • 28. Reviva | Corporate Presentation 28 Laxminarayan Bhat, PhD Founder, President and CEO Narayan Prabhu, CPA Chief Financial Officer Harald Murck, MD Sr VP Clinical Development Sangita Ghosh, PhD Sr VP Pharm Development Seema Bhat, MS, CTDM, PMP VP Program & Portfolio Kevin Charrier VP Quality Assurance Experienced Management Team 20+ years of experience in drug discovery and clinical development
  • 29. Reviva | Corporate Presentation 29 Pipeline-in-a-Product Opportunities for Lead Asset Brilaroxazine IL-18; Interleukin-18. Differentiated pharmacology profile as modulator of serotonin and dopamine signaling pathways implicated in neuropsychiatric and inflammatory diseases Multifaceted Activity for Brilaroxazine Ongoing pivotal Phase 3 trial in schizophrenia with expansion potential in neuropsychiatric disorders and inflammatory diseases Late-Stage Clinical Development Near-term Catalysts Topline data for pivotal Phase 3 trial in schizophrenia expected in Q3 2023
  • 30. Cupertino, CA Bangalore, India Investor Relations Contact IR@Revivapharma.com info@Revivapharma.com General Inquiries Reviva Pharmaceuticals Holdings, Inc. International Offices Bangalore, India U.S. Headquarters Cupertino, CA, USA Global Operations Business Inquiries busdev.rp@Revivapharma.com