Mira Pharmaceuticals, Inc. · NASDAQ:MIRA
Mira Pharmaceuticals — Investor Presentation (October 2026)
30 slides from Mira Pharmaceuticals's investor presentation, October 2026
Slide 1: An Oral Selective NMDA Modulator in CIPN
NASDAQ: MIRA An Oral Selective NMDA Modulator in PHASE 1 COMPLETE CIPN Chemotherapy-induced 57* Volunteers Peripheral Neuropathy 30–40% 0 SAEs of chemo patients 50–600 mg (CIPN) Zero FDA-approved treatments *Including one voluntary withdrawal after initial dosing for reasons unrelated to safety Octo
Slide 2: Led by Experienced Management
Led by Experienced Management Chief Executive Officer & Erez Andriy Chief Financial Officer Executive Chairman Aminov Mushak, Strategic architect of MIRA's CPA 20+ years of SEC reporting and pipeline. Drives capital markets accounting experience. Leads and development strategy. financial reporting,
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "wou
Slide 4: Why MIRA. Why Now.
Why MIRA. Why Now. Four reasons institutions should be paying attention UNMET NEED DIFFERENTIATED ASSET CLINICAL PROOF CURRENT STATUS Zero FDA-Approved No Evidence of Phase 1 Complete. Phase 2a Protocol Treatments for CIPN Psychotropic Risk. Not a Phase 2a Imminent. Submitted to FDA Controlled Subst
Slide 5: CIPN: The Forgotten Oncology Crisis
Chemotherapy-Induced CIPN: Peripheral Neuropathy The Forgotten Oncology Crisis The most common dose-limiting toxicity Affects sensation, motor function, and 30–40% 100% of cancer treatment quality of life — often of chemo patients off-label current standard of care permanently affected globally1 (Un
Slide 6: CIPN Today. A Path Into an $8B+ Neuropathic Pain Market
CIPN Today. A Path Into an Market Opportunity $8B+ Neuropathic Pain Market $8B+ New persistent CIPN cases estimated annually Global ~3 Million worldwide1 Neuropathic Pain Market3 discontinue or reduce chemotherapy due to Severe CIPN 40% (United States)2 CIPN Market by 2033 0 FDA-approved treatments
Slide 7: Ketamir-2: Rethinking NMDA Modulation with Selectivity
Ketamir-2: Rethinking NMDA Modulation with Selectivity Rationale: MECHANISM SELECTIVITY STATUS Ketamir-2 is an oral, low-affinity NMDA No binding to AMPA, Kainate, Sigma, Glycine, Phase 1 complete. Phase 2a protocol receptor modulator acting at the PCP site or Glutamate receptors. Active metabolite
Slide 8: Near-Term Catalysts: Multiple Value Inflection Points
Near-Term Catalysts: Multiple Value IND Phase Inflection Points Active Phase 2a Prep 2a Enrollment Begins IND active, no clinical Site activation and patient hold. Phase 2a trial design enrollment begin. finalized. Site selection finalized with top-tier cancer center. AACR Phase 2a Annual Meeting Pr
Slide 9: Ketamir-2 IP Protection
Ketamir-2 IP Protection Protected IP, Worldwide Exclusivity Global patent protection is pending for Ketamir-2 and its therapeutic uses • (WO 2024/191676 A1 — "Antidepressant Compounds, Pharmaceutical Compositions, and Methods of Treating Depression, Pain and Other Disorders") MIRA holds an exclusive
Slide 10: Capital-Efficient Path to Phase 2a
Capital-Efficient Path to Phase 2a Balance Sheet Why This Matters MIRA's debt-free balance sheet and lean operating structure support a capital-efficient path toward Phase 2a CIPN. Debt- $0 Debt Free • Capital-efficient Phase 2a Annual Burn design, lean trial structure Disciplined • NASDAQ-listed wi
Slide 11: Preclinical Evidence: Outperforming Gold Standard
Preclinical Evidence: Outperforming Gold Standard PTX Model (Paclitaxel-Induced CIPN) Complete Outperformed Ketamir-2 achieved full pain reversal at 100–300 mg/kg in the paclitaxel Pain Reversal Gabapentin & model — the most clinically relevant CIPN model. Gabapentin and vs. Partial Relief Pregabali
Slide 12: Appendix Pre-clinical
MIRA Pharmaceuticals, Inc. Appendix Pre-clinical This presentation is for informational purposes only and does not constitute an offer to sell or solicitation of an offer to buy any securities. 12
Slide 13: Ketamir-2 Produces Dose-Dependent Pain Reversal in Mice Post-PTX Treatment
Ketamir-2 Produces Dose-Dependent Pain Reversal in Mice Post-PTX Treatment Complete reversal to baseline at 100–300 mg/kg — outperforming Gabapentin in the gold-standard CIPN model Male — Filament type (gr) vs. timepoint across Female — Filament type (gr) vs. timepoint dose groups across dose groups
Slide 14: Ketamir-2 Demonstrates Potent Pain Relief in Chung Spinal Nerve Ligation Model
Ketamir-2 Ketamir-2Demonstrates Potent Demonstrates Pain Relief Potent Pain in the Chung Relief Spinal Nerve in Validated Ligation AnimalModel Models Dose-dependent reversal of allodynia — outperforming Pregabalin and Gabapentin across both sexes Study Model Male — Filament type (gr) vs. timepoint.
Slide 15: Clinical studies
MIRA Pharmaceuticals, Inc. Clinical studies This presentation is for informational purposes only and does not constitute an offer to sell or solicitation of an offer to buy any securities. 15
Slide 16: Mira-001 Phase 1: Unblinded Results – 57 Healthy Volunteers
Mira-001 Phase 1: Unblinded Phase 1 Results – 57* Healthy Volunteers Healthy 57* Volunteers Hadassah Medical Center, Jerusalem — Rigorous Academic Oversight Serious 0 Adverse Events Randomized (3:1), double-blind, placebo-controlled SAD + MAD design. 57* healthy volunteers across 7 cohorts, includin
Slide 17: Mira-001 Phase 1 Study Design
Mira-001 Phase 1 Study Design Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) Cohorts 1–4 Cohorts 5–7 ● Cohort #1: Single dose of 50 mg (1 x 50 mg ● Cohort #5: 150 mg (3 x 50 mg capsules) capsule) on Day 1 once daily for 5 days ● Cohort #2: Single dose of 150 mg (3 x 50 ● Cohort #6: 300 mg
Slide 18: Mira-001 Phase 1 Study – Demographics
Mira-001 Phase 1 Study – Demographics Unit Mean ± SEM Age Years 21.7 ± 3 Height cm 174.9 ± 6.7 Weight Kg 70.6 ± 9.0 BMI Kg/m2 23.0 ± 2.0 45/57* – Male (80.7%) Sex 11/57 – Female (19.3%) *Including one voluntary withdrawal after initial dosing for reasons unrelated to safety. 18
Slide 19: Mira-001 Phase 1 Study Results – Safety Summary
Mira-001 Phase 1 Study Results – Safety Summary Active (n=43*) Placebo (n=14) Subjects % Subjects % Overall TEAEs 16 37.2 7 50 Cardiovascular 2 4.7 1 7.1 Ear and Labyrinth 1 3.3 1 7.1 Gastrointestinal 3 7 4 28.6 Metabolism 0 0 1 7.1 Muscular spasm 2 4.7 1 7.1 CNS 12 27.9 5 35.7 Dizziness 7 16.3 3 21
Slide 20: Mira-001 Phase 1 Study Results – Safety Summary
Mira-001 Phase 1 Study Results – Safety Summary The overall incidence of TEAEs in No SAEs, TEAEs that led to The overall safety and tolerability the active arm (37.2%) was treatment discontinuations, profile supports continued comparable to placebo (50%), Grade ≥3 events, or deaths were clinical dev
Slide 21: Plasma Concentration-time Profiles (Cohorts 1–4)
Plasma Concentration-time Profiles for Ketamir-2 and Nor- Ketamir (Cohorts 1–4) Ketamir-2 Nor-Ketamir-2 300 800 Group Group Cohort 1: 50mg (1 X 50mg capsule) on Day 1 Cohort 1: 50mg (1 X 50mg capsule) on Day 1 Cohort 2: 150mg (3 X 50mg capsule) on Day 1 Cohort 2: 150mg (3 X 50mg capsule) on Day 1 Co
Slide 22: Plasma Concentration-time Profiles (Cohorts 5–7)
Plasma Concentration-time Profiles for Ketamir-2 and Nor- Ketamir (Cohorts 5–7) Ketamir-2 Nor-Ketamir-2 Day 1 Day 5 Day 1 Day 5 500 600 400 Concentration (ng/mL) Concentration (ng/mL) 300 400 200 200 100 0 0 0 5 10 15 20 25 0 5 10 15 20 25 0 5 10 15 20 25 0 5 10 15 20 25 Time (hr) Time (hr) Group Gr
Slide 23: Mira-001 Phase 1 Study Results – PK Summary
Mira-001 Phase 1 Study Results – PK Summary Following oral administration, Ketamir-2 was rapidly absorbed across all dose levels, with median Tmax The plasma half-life of Nor-Ketamir of 1.0–2.0 hours in SAD cohorts and 1.0–2.5 hours (approximately 6.5–8.5 hours in SAD) was longer in MAD cohorts, wit
Slide 24: Mira-001 Phase 1 Study Conclusion
Mira-001 Phase 1 Study Conclusion The safety and PK data from this study support the continued clinical development of Ketamir-2, with a favorable tolerability profile and preliminary PK characterization across doses up to 600 mg, that provides an initial basis for dose selection in future clinical
Slide 25: Ketamir-2: Clinical Phase 2a Study Design
Ketamir-2: Clinical Phase 2a Study Design Current Design with Top Cancer Institution Support Randomized, Double-Blind, Placebo-Controlled, Three-Period Crossover, Single-Center Study to Evaluate the Safety, Tolerability, and Dose-Response Relationship of Oral Ketamir-2 300 mg Ketamir-2 300 mg Ketami
Slide 26: Mira-001 Phase 2 Projected Efficacy Calculations
Mira-001 Phase 2 Projected Efficacy Calculations Dose Rat Cmax levels Human Cmax Efficacy in animal models of Ketamir-2 levels of Ketamir-2 (ng/ml) (ng/ml) 30 (mg/kg) 42* MED in CIPN and Neuropathy models 100 (mg/kg) 127 Maximal effects in CIPN and Neuropathy models. Effective dose in depression and
Slide 27: Pipeline
Pipeline Lead Asset Asset Asset Ketamir-2 SKNY-1 MIRA-55 Indication Indication Indication CIPN Obesity / Smoking Cessation Inflammatory Pain Preclinical ✓ Preclinical Active Preclinical Active Phase 1 ✓ IND Submission 1H 2027* IND Submission 1H 2027* Phase 2a Initiation Q1 2027* Pipeline spans pain,
Slide 28: SKNY-1: Peer-Reviewed Preclinical Data in Obesity and Nicotine Addiction
SKNY-1:Peer-Reviewed SKNY-1: Peer-Reviewed Preclinical Preclinical Evidence Data in in Obesity Obesity and Nicotine& Nicotine Addiction Addiction ~30% weight reduction, lean mass preserved, and nicotine-seeking attenuated — in a single oral, non-controlled compound Reduction in Body weight (%) Chang
Slide 29: MIRA-55: Morphine-Comparable Analgesic Without Intoxication
MIRA-55: MIRA-55: Morphine-Comparable Morphine-Comparable Analgesic Pain Relief Efficacy Without in Validated Intoxication, Preclinical Sedation, Models or Opioid Liability Without intoxication, sedation, or opioid liability Pressure Sensitivity for Pain What Is MIRA-55 ● Pure synthetic THC analog —
Slide 30: MIRA Pharmaceuticals, Inc. NASDAQ: MIRA
MIRA Pharmaceuticals, Inc. NASDAQ: MIRA Phase 1 Complete. Targeting the First FDA-Approved CIPN Therapy. Investor Relations: info@mirapharma.com www.mirapharmaceuticals.com This presentation is for informational purposes only and does not constitute an offer to sell or solicitation of an offer to bu
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