MIRA Pharmaceuticals, Inc. · NASDAQ:MIRA
MIRA Pharmaceuticals — Investor Presentation (June 2025)
36 slides from MIRA Pharmaceuticals's investor presentation, June 2025
Slide 1: NASDAQ:MIRA June 2025
NASDAQ:MIRA June 2025 ©2023 MIRAPharmaceuticals, Inc. All Rights Reserved.
Slide 2: Management
Management Erez Aminov Itzchak Angel, PhD Chief Executive Officer & Excutive Chairman Chief Scientific Advisor ► Experienced biotechnology investor and adviser with ► Over 40 years of experience in guiding medical, 18+yearsof experience pharmaceutical, drug, and business development in both large an
Slide 3: Corporate Overview
Corporate Overview uWe are MIRA Pharmaceuticals — a clinical- stage biotech developing oral therapies that target the brain, behavior, and metabolism. uOur pipeline includes: uKetamir-2 – a next-generation oral ketamine analog with improved bioavailability, selectivity, and safety profile. It is cur
Slide 4: Our pipeline
Our pipeline Early preclinical In vivo studies IND Clinical studies Ketamir-2 Topical pain Neuropathic pain (oral) PTSD Cognition enhancement Mira-55 Inflammatory pain Obesity SKNY-1 Smoking cessation Investor Presentation | Nasdaq: MIRA
Slide 5: What is MIRA-55?
Whatis MIRA-55? Key Differentiating Factors THC MIRA-55 Schedule 1, which means no Pure Synthetic accepted medical purpose Based on preclinical studies, better side effect profile (e.g. Negative side effects decreased anxiety across the dose range, improved rather than impaired cognition) Legal/regu
Slide 6: Therapeutic Focus Areas
Therapeutic MIRA-55 is under evaluation for two key therapeutic areas with high FocusAreas disease burden and significant unmet needs Cognitive Impairment Anxiety and Cognitive Decline in the Elderly Anxiety disorders are chronic conditions marked by an Cognitive Impairment encompasses conditions ma
Slide 7: Large Patient Populations with Limited Treatment Options
Large Patient Populations with Limited Treatment Options MIRA-55 addresses a multibillion-dollar opportunity in anxiety and cognitive decline — with up to 14 million patients actively seeking safer, more effective therapies. • Mild Cognitive Impairment & Early Dementia: -33M eligible; 4.95–6.6M addr
Slide 8: MIRA-55 Reduces Anxiety Without Sedation or Intoxication
MIRA-55 Reduces Anxiety Without Sedation or Intoxication In the Elevated Plus Maze, mice treated with MIRA-55 spent more time exploring open areas — a clear sign of reduced anxiety — without showing signs of sedation. • Validated Model: The Elevated Plus Maze tests anxiety by measuring time spent in
Slide 9: MIRA-55 Shows Significant Pain Relief in Thermal Sensitivity Model
MIRA-55 Shows Significant Pain Relief in Thermal Sensitivity Model Mice treated with MIRA-55 took longer to react to heat — a clear sign of reduced pain sensitivity compared to placebo. • Validated Model: Mice were placed on a heated plate and observed for paw-lift response time • Reduced Pain Sensi
Slide 10: MIRA-55 Enhances Memory Recall in Contextual Fear Conditioning
MIRA-55 Enhances Memory Recall in Contextual Fear Conditioning In a validated cognitive model, MIRA-55 significantly improved memory performance — suggesting enhanced associative learning with no sedative tradeoffs. • Model Overview: Mice were trained to associate a chamber with a mild shock; freezi
Slide 11: Regulatory Pathway to Commercialization
Regulatory Pathway to Commercialization To develop, MIRA-55 as a commercialization asset, we are proceeding on a well-established regulatory pathway designed to establish its safety and efficacy 1 2 Pre-Clinical Testing Clinical Trials Focus on pre-clinical testing Clinical testing and trials includ
Slide 12: Ketamir-2: A Novel Oral Approach to Treating Neuropathic Pain
Ketamir-2: A Novel Oral Approach to Treating Neuropathic Pain An advanced ketamine analog with fewer side effects, better safety, and clinical-stage momentum. • What is Ketamir-2? A next-generation oral ketamine analog with improved bioavailability, selectivity, and safety profile, specifically engi
Slide 13: Neuropathic Pain: High Prevalence, Low Satisfaction, and Urgent Demand
Key Therapeutic Area Neuropathic Pain: High Prevalence, Low Satisfaction, and Urgent Demand An underserved patient population where existing treatments fall short — and the risk of addiction runs high. • Widespread and Costly Neuropathic pain affects 7–10% of the population globally, often linked to
Slide 14: Precision Targeting at the NMDA Receptor — Without the Collateral Effects
Precision Targeting at the NMDA Receptor — Without the Collateral Effects A novel oral NMDA antagonist with selective PCP-site binding and none of ketamine’s psychomimetic baggage. • Low-Affinity, Highly Selective NMDA Modulation Ketamir-2 acts as a low-affinity antagonist at the PCP-site of the NMD
Slide 15: CNS Differentiation Without Hyperlocomotion or Euphoria
•Further differentiates Ketamir-2 from existing NMDA-targeting compounds CNS Differentiation Without Hyperlocomotion or Euphoria Unlike ketamine, Ketamir-2 does not induce hyperactivity — a key signal of reduced psychomimetic liability. • Preclinical locomotor activity testing confirms no increase i
Slide 16: Ketamir-2 Demonstrates Potent Pain Relief in Validated Animal Models
Ketamir-2 Demonstrates Potent Pain Relief in Validated Animal Models Effective across sexes, models, and doses — with statistically significant reversal of neuropathic pain. • Chung Model (Rats – Visual 1): - Male and female rats with spinal nerve ligation • - Ketamir-2 produced dose-dependent rever
Slide 17: Ketamir-2 Promotes Antidepressant-Like Behavior Without Stimulant Effects
Ketamir-2 Promotes Antidepressant-Like Behavior Without Stimulant Effects Demonstrates increased movement and velocity without hyperactivity — mirroring classical antidepressant responses in the Open Field Test • Open Field Test is a validated model for screening antidepressant and anxiolytic activi
Slide 18: Ketamir-2 Shows Anxiolytic-Like Effects in Elevated Plus Maze
Ketamir-2 Shows Anxiolytic-Like Effects in Elevated Plus Maze Demonstrates increased movement and time in center — consistent with reduced anxiety and enhanced exploratory behavior • Elevated Plus Maze is a classical assay used to assess anxiolytic and antidepressant activity based on exploratory be
Slide 19: Ketamir-2 Shows Superior Oral Bioavailability and Brain Penetration Potential
Ketamir-2 Shows Superior Oral Bioavailability and Brain Penetration Potential Not a substrate of P-gp efflux transporter — enabling improved absorption and CNS exposure compared to ketamine • Caco-2 assay results confirm Ketamir-2 is not a substrate for P- glycoprotein (P-gp), unlike ketamine. • Ket
Slide 20: Ketamir-2 Summary: Preclinical Profile Supports Further Development
Ketamir-2 Summary: Preclinical Profile Supports Further Development Mechanistically selective, orally bioavailable, and non-genotoxic — with consistent activity across models of depression, anxiety, and neuropathic pain Chemistry & Formulation (CMC) -Ketamir-2 is a stable crystalline analog of ketam
Slide 21: Ketamir-2 vs Gabapentin in the PTX model, male mice
Comparative effects of several oral doses of Ketamir-2 to Gabapentin in the PTX model of Neuropathic pain in male mice. Male mice were evaluated in the right and left legs 9 days following PTX treatment. As can be seen a marked allodynia was observed. We can see a significant effect as from 30 mg/kg
Slide 22: Ketamir-2 vs Gabapentin in the PTX model, female mice
Comparative effects of several oral doses of Ketamir-2 to Gabapentin in the PTX model of Neuropathic pain in female mice Female mice were evaluated in the right and left legs 9 days following PTX treatment. As can be seen a marked allodynia was observed with higher sensitive than male mice.. We can
Slide 23: Ongoing Phase 1 Trial: Cohort 3 Complete, Preparing for Cohort 4
Ongoing Phase 1 Trial: Cohort 3 Complete, Preparing for Cohort 4 To date, 18 participants have completed dosing with no serious or dose-limiting adverse events reported. • Phase 1 trial is ongoing — Cohort 3 has completed dosing with no serious or dose-limiting adverse events reported to date • Prep
Slide 24: Ketamir-2 Development Pathway Toward Phase IIa in Neuropathic Pain
•Further differentiates Ketamir-2 from existing NMDA-targeting compounds Ketamir-2 Development Pathway Toward Phase IIa in Neuropathic Pain A strong foundation from preclinical and Phase 1 data supports rapid advancement into diabetic neuropathy patients. Market Opportunity: Phase IIa Study Design O
Slide 25: A Next-Generation Approach to Obesity & Smoking Cessation
A Next-Generation Approach to Obesity & Smoking Cessation Unlocking Metabolic and Behavioral Health Innovation Through SKNY-1 • Oral small molecule THCV analog with non-controlled status • Multi-mechanistic profile: CB1 antagonist, CB2 partial agonist, MAO-B inhibition • Designed to address obesity,
Slide 26: The Endocannabinoid System: A Master Regulator of Metabolism and Craving
The Endocannabinoid System: A Master Regulator of Metabolism and Craving CB1 and CB2 receptors influence appetite, insulin sensitivity, lipid metabolism, and reward — making them ideal targets for obesity and addiction. • Appetite • Body • Insulin regulation weight • Lipid levels • CB1 and CB2 recep
Slide 27: Multi-Target Mechanism to Address Complex Metabolic and Behavioral Conditions
Multi-Target Mechanism to Address Complex Metabolic and Behavioral Conditions SKNY-1’s unique combination of activities enables broad therapeutic coverage across obesity, addiction, and metabolic dysregulation. • CB1 Antagonism: Reduces appetite, body weight, and craving by dampening central reward
Slide 28: A Safer Path Forward: Receptor Bias Minimizes Psychiatric Side Effects
A Safer Path Forward: Receptor Bias Minimizes Psychiatric Side Effects SKNY-1’s peripheral action and arrestin bias offer safety advantages over earlier CB1-targeting drugs. • Biased CB1 Modulation: Selectively blocks β-arrestin signaling without blocking CB1 agonists, while showing only low-affinit
Slide 29: SKNY-1: Tackling Obesity with a Differentiated Mechanism
SKNY-1: Tackling Obesity with a Differentiated Mechanism Designed to modulate appetite and metabolism without the psychiatric baggage of first-generation CB1 blockers. • Selective modulation of CB1 receptor without β-arrestin activation — may reduce CNS-related side effects • Demonstrates partial ag
Slide 30: Avoiding the Pitfalls of First-Generation CB1 Blockers
Avoiding the Pitfalls of First-Generation CB1 Blockers Designed to retain metabolic benefit while minimizing psychiatric burden • Earlier CB1 blockers like Rimonabant were effective in reducing weight and improving metabolic parameters — but failed due to CNS-related psychiatric side effects (e.g.,
Slide 31: Comparison to Monlunabant: A Safer, More Selective Alternative
Comparison to Monlunabant: A Safer, More Selective Alternative SKNY-1 demonstrates a differentiated pharmacological profile compared to third-generation CB1-targeting drugs like Monlunabant (MRI-1891), with important safety and mechanistic distinctions. • No G-Protein Coupled Antagonism: Unlike Monl
Slide 32: MAO-B Inhibition: Enhancing Motivation and Reducing Craving
MAO-B Inhibition: Enhancing Motivation and Reducing Craving SKNY-1 selectively and weakly inhibits MAO-B — supporting dopaminergic tone with minimal CNS risk. • Low-Affinity, Selective MAO-B Inhibition: SKNY-1 inhibits MAO-B (EC₅₀ ≈ 300 µM) with minimal effect on MAO-A (EC₅₀ > 1000 µM), avoiding off
Slide 33: SKNY-1's Multi-Tissue Action: A Coordinated Strategy for Obesity and Addiction
•Further differentiates Ketamir-2 from existing NMDA-targeting compounds SKNY-1’s Multi-Tissue Action: A Coordinated Strategy for Obesity and Addiction A single compound influencing central and peripheral targets — uniting metabolic, behavioral, and inflammatory control. • Brain: Modulates CB1 and i
Slide 34: Advancing SKNY-1 Toward Strategic Partnership and Clinical Validation
•Further differentiates Ketamir-2 from existing NMDA-targeting compounds Advancing SKNY-1 Toward Strategic Partnership and Clinical Validation Differentiated science, druggable profile, and commercial opportunity converge in SKNY-1 • Highly differentiated THCV-analog small molecule with CB1/CB2/MAO-
Slide 35: Investment Highlights
Investment Highlights KETAMIR-2 MIRA-55 SKNY-1 Ketamir-2 is a novel oral ketamine analog MIRA-55 is a synthetic cannabinoid SKNY-1 is a THCV-based compound with with improved bioavailability, CNS designed to reduce anxiety and CB1 antagonist, CB2 partial agonist, and selectivity, and a clean safety
Slide 36: Thank you.
Thank you. mirapharmaceuticals.com Meeting Presentation
MIRA Pharmaceuticals — Investor Presentation (June 2025) on 6ix