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MIRA Pharmaceuticals : Investor Presentation
MIRA Pharmaceuticals : Investor

About this update from Mira Pharmaceuticals, Inc.
NASDAQ: MIRA April 2026 ©2023 MIRA Pharmaceuticals, Inc. All Rights Reserved. Investor Presentation | Nasdaq: MIRA Management Erez Aminov Chief Executive Officer & Executive Chairman Itzchak Angel, PhD Chief Scientific Advisor Biotechnology executive with a track record of advancing drug candidates from preclinical development through IND submission and into clinical-stage development. Chairman and CEO of Mira Pharmaceuticals (Nasdaq: MIRA), where he has advanced the Company's lead program from preclinical development through IND submission and successful Phase 1 completion, and is progressing into Phase 2, while expanding the pipeline with additional candidates advancing toward IND. Proven ability to execute across clinical development, regulatory strategy, and capital markets, including securing financing and executing strategic asset acquisitions and licensing transactions to expand the pipeline and drive shareholder value. Also serves as Chairman and CEO of Telomir Pharmaceuticals (Nasdaq: TELO), where he is advancing an oncology program following IND submission. Over 40 years of experience in guiding medical, pharmaceutical, drug, and business development in both large and emerging companies. Expertise in small molecules, botanical drugs, Biotechnology products, delivery systems, medical devices, and drug-device combinations. Former Head of Pharmacology at Synthelabo (Sanofi-Aventis, Paris, France) where he participated in research and development of drugs such as Xatral (alfuzosin), Ambien (zolpidem) and Mizollen (mizolastine). Alan Weichselbaum, CPA, MBA Chief Financial Officer Alex Weisman, PhD Scientific Advisor Seasoned Financial Executive with 30+ years of experience in corporate finance, capital markets, and strategic advisory; currently CFO of both MIRA and Telomir Pharmaceuticals. Board and Advisory Leadership as Director of FinWise Bancorp (Nasdaq: FINW) and founder of The Wexus Group, advising growth-stage companies on capital structuring and exit strategies. Capital Markets Expertise gained through senior Wall Street roles, hedge fund management, and leadership in institutional transactions across public and private markets. Occupied executive positions of VPR & D and Chief Scientist at numerous Israeli and international pharmaceutical companies. Currently serve as an advisor and management team member for companies developing new products for the chemicals, pharmaceuticals, and food industries. More than 30 years of experience in the development, characterization, scale-up, technology transfer, trouble shooting, production and registration of novel and generic drugs, and other pharmaceutical and chemical products. Investor Presentation | Nasdaq: MIRA 1 Confidential - Do Not Distribute Corporate Overview We are MIRA Pharmaceuticals - advancing a differentiated pipeline of oral therapies for neurologic, neuropsychiatric, and metabolic disorders. Built on safety and efficacy, our programs target high-value markets with significant unmet need and strong clinical demand. Our pipeline includes: Ketamir-2 - a next-generation oral ketamine analog with improved bioavailability, selectivity, and safety profile. Completed Phase 1 clinical study with favorable safety and tolerability; advancing toward Phase 2a in chemo-induced neuropathic pain. SKNY-1 - a THCV analog designed for obesity and smoking cessation. It modulates CB1, CB2, and MAO-B with receptor selectivity that minimizes psychiatric risk and supports metabolic balance. MIRA-55 - a THC analog designed to reduce anxiety and improve cognition in aging populations, showing activity across models of memory, inflammatory pain, and behavioral regulation. Investor Presentation | Nasdaq: MIRA 2 Our Pipeline Indications Pre-Clinical Phase-I Phase-II Ketamir-2 Chemo-Induced Peripheral Neuropathy (CIPN) Mira-55 Inflammatory Pain SKNY-1 Obesity Smoking Cessation Investor Presentation | Nasdaq: MIRA 3 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 engineered for neuropathic pain, chemotherapy-induced peripheral neuropathy (CIPN) and treatment-resistant depression. Neuropathic Pain: A Major Unmet Need: Affects 7-10% of the global population, including patients with diabetic neuropathy, postherpetic neuralgia, CIPN and MS-related pain. Current treatments are often ineffective or come with significant side effects and addiction risks. Why It Matters to Pharma Leaders: Existing therapies (anticonvulsants, SNRIs, opioids) offer limited efficacy and poor tolerability. DEA review confirmed Ketamir-2 is not a controlled substance, making it a safer, rapid-acting oral alternative with clear regulatory and commercial advantages. Current Status: Undergoing a Phase I clinical trial at Hadassah Medical Center in Israel, showing promising early tolerability and safety. Investor Presentation | Nasdaq: MIRA 4 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 diabetes, CIPN, MS, shingles, and nerve injury. It's one of the most common forms of chronic pain. Current Treatments Are Insufficient First-line therapies like gabapentin, pregabalin, and SNRIs offer limited relief and come with CNS side effects, sedation, or tolerance concerns. Opioids are a last resort, burdened by addiction risk. No Oral, Rapid-Acting, Low-Abuse Option Exists Today There's a significant gap in the market for a therapy that is oral, non-addictive, and provides fast-acting, targeted relief without psychomimetic or sedative effects. Opportunity Entering this space positions any firm as a leader in next-generation non-opioid pain therapeutics, aligned with both public health priorities and long-term CNS portfolio expansion. Investor Presentation | Nasdaq: MIRA 5 Key Therapeutic Area Treatment Resistance Depression (TRD) & Post-Traumatic Stress Disorder (PTSD): High Prevalence, Limited Options, and Urgent Demand An underserved patient population where existing treatments fall short - and safe, effective options remain scarce. Widespread and Costly: TRD affects ~30% of major depression patients who fail ≥2 antidepressant therapies. PTSD affects 3.6% (past-year) and 6.8% (lifetime) of U.S. adults, with millions more worldwide. Current Treatments Are Insufficient: TRD: Limited efficacy from SSRIs, SNRIs, and augmentation therapies; high relapse rates. PTSD: Standard options (SSRIs, therapy) leave many patients with residual symptoms or intolerable side effects. No Oral, Rapid-Acting, Low-Abuse Option Exists Today: Market gap for therapies that are fast-acting, well-tolerated, and non-addictive, addressing both mood and trauma-related symptoms. Opportunity: TRD global market: $1.3-2.2B (2024-2025), growing 4-9% CAGR. PTSD global market: $2.2-3.0B (2024), steady growth ~4% CAGR. Expanding into TRD & PTSD positions Ketamir-2 as a potential first-in-class oral option across high-need psychiatric indications. Investor Presentation | Nasdaq: MIRA 6 Confidential - Do Not Distribute Ketamir-2: CMC Simple and scalable process for drug substance and drug product production. Drug Substance Manufacturing Process Simple, high yield drug substance synthesis Source for Starting Material of high quality established and approved. No impurities over 0.10% originated from Starting material in the Drug substance High Drug substance quality attributes Particle size distribution controlled by precipitation process Scaled up to 1.7 kg /GMP batch Physical Properties Complete characterization of crystalline form (FT-IR, Raman, SS-NMR, pXRD, SEM) performed. Reproducibility of crystalline form for all manufactured lots confirmed. Stability Studies Drug substance was found stable (no trends in quality parameters) for 9 months. Drug Product Hard gelatine capsules of 50mg and 300 mg developed Dissolution criteria in accordance with USP requirements Drug products were found stable (no trends in quality parameters) for 6 months. Investor Presentation | Nasdaq: MIRA 7 Ketamir-2: Pharmacology 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 NMDA receptor, with an IC₅₀of~100µM-avoiding the broader binding that drives ketamine's side effects. No Off-Target Binding to Problematic Sites Unlike ketamine, Ketamir-2 does shows no binding to: AMPA, Kainate, Sigma, Glycine or Glutamate receptors → This greatly reduces psychosis-like effects, sedation, and misuse potential. Improved Safety Profile Confirmed in Nor-Ketamir Metabolite Its active metabolite shows similarly selective NMDA antagonism (IC₅₀ ~300 µM), reinforcing a consistent, predictable pharmacodynamic profile. Differentiated CNS Action Without Hyperactivity or Euphoria In vivo data confirms no hyperlocomotion or euphoria, highlighting Ketamir-2's differentiated CNS profile in schizophrenia-relevant behavioral models. Binding and inhibition data for Ketamir-2 and Nor-Ketamir at the s tes. NMDAPCP-site. No significant activity at other glutamatergic receptor Investor Presentation | Nasdaq: MIRA 8 Ketamir-2: Pharmacology CNS Differentiation Without Hyperlocomotion or Euphoria Unlike ketamine, Ketamir-2 does not induce hyperactivity - a key signal of reduced psychomimetic liability. Clinical locomotor activity testing confirms no increase in spontaneous movement with oral or injected Ketamir-2 In contrast, ketamine (20 mg/kg, i.p.) significantly elevated horizontal locomotion Supports low risk of psychomotor activation, dissociation, or abuse liability Ketamir-2 (mg/kg, ip) Ketamir-2 (50 mg/kg) (po) Further differentiates Ketamir-2 from existing NMDA-targeting compounds Figure: Spontaneous hyperlocomotion in mice (1 hour) Results are expressed as mean ± SEM ***:p<0.001 for ketamir (50mg/kg,ip) vs vehicle (ip) by one-way ANOVA test followed by a Dunnett's multiple comparisons test ###:p<0.001 for ketamine (20mg/kg,ip) vs vehicle (ip) by two-tailed Student's t test for 9 Investor Presentation | Nasdaq: MIRA Ketamir-2: Pharmacology Validated Rodent Model for Neuropathic Pain Evaluation The Chung Model simulates clinically relevant nerve injury to assess therapeutic effects in neuropathic pain. Surgical Procedure- Ligation of L5 and L6 spinal nerves induces partial nerve injury, mimicking human neuropathic pain. Behavioral Outcomes- Rats exhibit mechanical allodynia - a key symptom of neuropathic pain - measurable using Von Frey filaments. Assessment Timeline- Pain response is evaluated on Day 14 and Day 21 post-ligation to capture both development and Persistence of pain. Investor Presentation | Nasdaq: MIRA 10 Visual Timeline- Treatment overlays the period of mechanical allodynia, providing insight into drug efficacy during peak sensitivity 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): - Male and female rats with spinal nerve ligation Ketamir-2 produced dose-dependent reversal of allodynia Stronger or equal to Ketamine; better than Pregabalin/Gabapentin Significant analgesic effects observed at 30-300 mg/kg (p < 0.01 to p < 0.001), with full reversal at 300 mg/kg. Male Investor Presentation | Nasdaq: MIRA Female 11 Ketamir-2: Pharmacology PTX-Induced Neuropathy Model in Mice Validates Mechanical Allodynia Development A chemotherapy-induced pain model mimicking clinical neuropathic symptoms-enabling evaluation of therapeutic interventions in a controlled, time-specific window. Model Overview: Paclitaxel (PTX) was administered intraperitoneally (2mg/kg) every other day for four doses to induce peripheral neuropathy. Assessment Timeline: Pain behavior measured by Von Frey filaments on Day 0 (baseline), Day 8, and Day 9. Readout: Mechanical allodynia evaluated 30 minutes post-test item administration on Day 9. Outcome Relevance: Provides a clinically relevant model for chemotherapy-induced neuropathic pain, supporting short-term pain reversal studies. Investor Presentation | Nasdaq: MIRA 12 Ketamir-2 Produces Dose-Dependent Pain Reversal in Mice Post-PTX Treatment Following paclitaxel-induced neuropathy, Ketamir-2 demonstrated significant and progressive pain relief starting at 30mg/kg PO, with complete reversal to baseline levels at 100-300mg/kg-outperforming Gabapentin in this validated pain model. Male Female Investor Presentation | Nasdaq: MIRA 13 Ketamir-2: Pharmacology 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 activity. Ketamir-2treatmentledtoasignificant, dose-dependent increase in total distance moved (Panel A) and velocity (Panel B). This pattern aligns with classical antidepressant effects, suggesting improved mood and motivation. No significant effect was observed with ketamine (30 mg/kg PO) - underscoring Ketamir-2's differentiation. Trend toward increased time in the center of the field (Panel C) suggests potential anxiolytic activity. Behavioral effects observed with Ketamir-2 occurred without signs of psychomotor overstimulation. Figure: Open field parameters. (A) Distance moved(cm); (B) mean velocity (cm/seconds) and (C) cumulative time spent in center (seconds). Significance values were obtained through One-Way ANOVA. Investor Presentation | Nasdaq: MIRA 14 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 behavior. Mice treated with Ketamir-2 moved significantly farther (Panel A) and faster (Panel B) than vehicle controls - reflecting increased mobility. Time spent in closed arms decreased(Panel C), suggesting reduced anxiety and greater willingness to explore open spaces. Ketamir-2 effects were dose-dependent, with increased activity seen at 100-300 mg/kg. Ketamine (30 mg/kg PO) showed no significant improvement, further d . ifferentiating Ketamir-2's anxiolytic potential. These findings reinforce Ketamir-2's behavioral signature consistent with clinical antidepressant and anxiolytic profiles. Figure Elevated plus maze (EPM) parameters. (A) Distance moved(cm); (B) mean velocity (cm/seconds), (C) cumulative time spent in open arms (seconds. Significant values were obtained through One-Way ANOVA . Investor Presentation | Nasdaq: MIRA 15 Ketamir-2: ADME 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. Ketamir-2 showed high intestinal absorption (AB: 80.6 × 10⁻⁶ cm/s) and low efflux (BA: -38.7), similar to the oral reference drug propranolol. In contrast, ketamine demonstrated higher efflux than absorption, a classic P-gp interaction profile. Net absorption(AB-BA)for Ketamir-2 was 41.9, compared to -15.1 for ketamine, supporting significantly better permeability. Predicted oral bioavailability of ~80%, exceeding that of ketamine's oral or intranasal routes. Supports potential for convenient, at-home, oral administration - improving treatment access and patient autonomy. Investor Presentation | Nasdaq: MIRA Figure: Data obtained from the CaCO-2 model of intestinal absorption. Propranolol, a commonly prescribed beta-blocker that is taken orally and used to treat hypertension, is included as a positive control. The intestinal absorption (AB), Intestinal efflux (BA) and net absorption (AB-BA) are shown. 16 Ketamir-2: ADME Rapidly absorbed and metabolized to active Nor-Ketamir Time Ketamir-2 pamoate in a specific 2-hydroxypropyl-beta-cyclodextrin(HP-β-CD formulation is rapidly absorbed It is metabolized to the Nor-Ketamir metabolite with has similar pcp-site activity and selectivity as Ketamir-2 Nor-ketamir has a long elimination half life (4.3 hours, vs 0.25 hours for Ketamir-2) and high levels (Cmax of 250 and 22 ng/ml, respectively) , representing 100% bioavailability compared to IV levels. It is also present in the brain in several time points measured Investor Presentation | Nasdaq: MIRA 17 Ketamir-2: ADME In Rats, females have higher levels of Ketamir-2 and Nor-Ketamir. Not seen in dogs. Female rats have a higher level of Ketamir-2 and Nor-Ketamir than males (Cmax of 127 and 1620 ng/ml Ketamir-2, and 1930 and 3790 ng/ml Nor-Ketamir, for males and females respectively) No kinetic sex differences were observed in dogs Figure depicts plasma levels following 100 mg/kg of Ketamir-2 oral administration Investor Presentation | Nasdaq: MIRA 18 Ketamir-2: Toxicology Excellent safety and toxicology profile Ketamir-2 was found to be highly selective across a broad receptor, enzymes and channels panel Non-mutagenic, non-genotoxic in standard assays Not neurotoxic in NMDA specific neurotoxicity study NOAELs: 300 mg/kg/day in rats; 200 mg/kg/day in dogs Investor Presentation | Nasdaq: MIRA 19 Investor Presentation | Nasdaq: MIRA
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