Slide 1: IGC Pharma Investor Presentation
Date: June 16, 2025 NYSEAmerican: IGC 1 NYSE AMERICAN: IGC - Service to humanity -
Slide 2: Safe Harbor
Safe Harbor The information presented in these slides includes forward - looking statements regarding the business prospects of IGC Pharma, Inc . ("IGC" or the "Company") . These forward - looking statements are based on management's current expectations as of the date of this presentation and are s
Slide 3: MoA Hypothesis: Dual-Agent Liquid Therapy for Alzheimer's
• Preclinical work done by Dr. Chuanhai Cao and his team at USF. • IGC - AD1’s technology is licensed from USF and protected by Patents. MoA Hypothesis: Dual - Agent Liquid Therapy for Alzheimer’s NYSEAmerican: IGC - Service to humanity 3
Slide 4: Stages of Drug Development
Stages of Drug Development Stages of Drug Development DRUG DISCOVERY AND PRE - CLINICAL CLINICAL Synthesis In vitro models • Tox studies • Efficacy studies Animal Models • Tox studies • Efficacy studies Formulation Development • Pharmaceutical form • Administration route • Stability and ǪC testing P
Slide 5: Hallmarks of Alzheimer's and Possible Mechanisms of Action
Main Brain Alterations in Alzheimer’s Disease IGC - AD1 IGC - AD1 Reduction of inflammation via CB2R Inhibiting beta amyloid aggregation Reducing Tau phosphorylation Activating mitochondrial function Chart: Wilson DM, Cookson MR, Van Den Bosch L, Zetterberg H, Holtzman DM, Dewachter I. Cell. 2023;18
Slide 6: Possible MoAs for Reducing Agitation in Alzheimer's
Possible IGC - AD1 MoAs for Reducing Agitation in Alzheimer’s Hallmarks of AD and possible IGC - AD1 MoA AGITATION Neurotransmitter imbalance of GABA, 5 - HT, DA, NE Tau phosphorylation A protein accumulation Synaptic loss Neuroinflammation Noradrenergic α1B and α2C receptors hyperactivity Loss of C
Slide 7: Undergone Rigorous Preclinical and Regulatory Review
IGC - AD1 Has Undergone Rigorous Preclinical and Regulatory Review and Is Approved for Clinical Investigation NYSEAmerican: IGC - Service to humanity 7
Slide 8: Meets All Mandatory Regulatory Requirements
IGC - AD1 meets all Mandatory Regulatory Requirements Tested and Verified for Ǫuality, Stability, and Consistency in Compliance with FDA Regulatory Standards The specification was developed by IGC Pharma in compliance with the applicable guidelines and pharmacopeias referenced in the regulatory colu
Slide 9: Specification Summary and Quality Characteristics
Specification Summary and Ǫuality Characteristics of IGC - AD1 IGC - AD1 Basic Ǫuality Profile Tested and Verified for Ǫuality, Stability, and Consistency in Compliance with FDA Regulatory Standards Company - owned data 9 NYSEAmerican: IGC - Service to humanity
Slide 10: APIs Exhibit 12-Month Stability Under Controlled Conditions
0 30 60 90 120 150 180 210 270 300 330 360 THC mg/ml 2.5 2.7 2.5 2.5 2.6 2.5 2.5 2.6 2.5 2.5 2.5 2.5 Melatonin mg/mL 1.5 1.64 1.39 1.47 1.35 1.26 1.5 1.43 1.61 1.51 1.46 1.53 0 3 2.7 2.4 2.1 1.8 1.5 1.2 0.9 0.6 0.3 mg/ml Days Stability of IGC - AD1 at 2 - 8 ƒ C IGC - AD1 APIs Exhibit 12 - Month Stab
Slide 11: Preclinical Toxicity Studies
Preclinical Toxicity Studies In vitro studies In vivo studies NYSEAmerican: IGC - Service to humanity 11
Slide 12: In Vitro Studies Show API is Non-Toxic to AD Cells
In Vitro Studies Show IGC - AD1 API is Non - Toxic to AD Cells Cao C, Li Y, Liu H, Bai G, Mayl J, Lin X, Sutherland K, Nabar N, Cai J. J Alzheimers Dis. 2014;42(3):973 - 84. doi: 10.3233/JAD - 140093 IGC - AD1 API treatment exhibited no cytotoxicity at the tested concentrations No significant differ
Slide 13: Mutagenic Assays Confirm Safety of API
Mutagenic Assays Confirm Safety of IGC - AD1 API IGC - AD1 API is Not Mutagenic in Regulatory - Compliant Testing Delgado - Murillo L, Galindo LD, Rodríguez - Soacha D, Gutiérrez E, Rao J, et al. Presented at: The Annual Genetic Toxicology Association Meeting; 2025; Newark, DE. Poster No: 20. AMES T
Slide 14: Preclinical Efficacy Studies
Preclinical Efficacy Studies In vitro studies In vivo studies NYSEAmerican: IGC - Service to humanity 14
Slide 15: API Exhibits Time- and Dose-Dependent Reduction of Aβ40 Production
API Exhibits Time - and Dose - Dependent Reduction of Aβ40 production While Aβ 42 is more fibrillogenic , Aβ 40 is highly abundant, influences plaque architecture, and contributes to vascular amyloid pathology . Reducing Aβ 40 may lower total amyloid load, improve vascular health, and shift the Aβ 4
Slide 16: API Inhibits Aβ40 Peptide Aggregation
API inhibit Aβ40 peptide aggregation Hypothesis : These findings support a potential direct interaction between the API and Aβ peptide , enabling the API to bind and inhibit Aβ aggregation , which may contribute to lowering amyloid burden in Alzheimer’s disease. Cao C, Li Y, Liu H, Bai G, Mayl J, Li
Slide 17: API Induces Dose-Dependent Decrease in GSK-3β and pGSK-3β
API Induces Dose - Dependent Decrease in GSK - 3β and pGSK - 3β Hypothesis : The API may exert neuroprotective effects by modulating GSK - 3 β and pGSK - 3 β activity, potentially reducing neuronal apoptosis through downregulation of this key kinase involved in Alzheimer’s - related tau phosphorylat
Slide 18: API Regulates Tau and pTau Expression and Crosses the BBB
API Regulates Tau and pTau Expression and Crosses the BBB Tau, pTau, and GSK3β Expression in APP/PS1 Mouse Brain Tissue In vivo studies comparing transgenic (TG) and non - transgenic (NTG) controls showed that treatment with IGC - AD1 API led to reductions in total Tau, phosphorylated Tau (pTau), an
Slide 19: API Enhances and Restores Mitochondrial Function in Brain Regions
API Enhances and Restores Mitochondrial Function in Relevant Brain Regions Mitochondrial Respiratory Activity in IGC - AD1 API - Treated APP/PS1 Mouse Model Treatment with IGC - AD1 API led to improved and restored mitochondrial function in the hippocampus and cortex, two regions affected in AD Hypo
Slide 20: APIs Restore Mitochondrial Function in AD Cell Model
APIs Restores Mitochondrial Function in AD Cell Model Study of Mitochondrial Respiratory Activity in IGC - AD1 API - Treated - APP/PS1 Mouse Model In N2a - APPswe AD cel model, IGC - AD1 APIs treatment restored basal respiration and fully restored maximal respiratory capacity. These results indicate
Slide 21: API Restores Mitochondrial Function in AD Cell Model
API Restores Mitochondrial Function in AD Cell Model Study of Mitochondrial Respiratory Activity in IGC - AD1 API - Treated N2a - APPswe cells IGC - AD1 API improves mitochondrial function in a concentration - dependent manner, achieving full restoration of Mitochondrial Membrane Potential (MMP) and
Slide 22: API Enhances Spatial Memory in APP/PS1 AD Mouse Model
IGC - AD1 API Enhances Spatial Memory in APP/PS1 AD Mouse Model In the Radial Arm Water Maze (RAWM) test, IGC - AD1 API treatment resulted in over a 50% reduction (p < 0.001) in both latencies to escape and number of errors in APP/PS1 transgenic mice, compared to untreated controls. Hypothesis : The
Slide 23: Summary: Preclinical Data
Summary: Preclinical Data Decreases Aβ₄₀ production and aggregation in cell models, implicates amyloid pathway modulation . 1 Reduces pTau and total Tau in transgenic mouse models. 2 Enhances mitochondrial function and restores respiratory capacity in AD models, supports neuronal survival and synapt
Slide 24: Phase 1 Trial Results
Phase I Randomized Placebo Controlled MAD Study to Evaluate Safety and Tolerability of IGC - AD1 in Subjects With Dementia Due to Alzheimer's Disease Phase 1 Trial Results 24 NYSEAmerican: IGC - Service to humanity
Slide 25: Phase 1 Objectives and End Points
Phase 1 · Objectives and End Points Primary: Safety and tolerability of IGC - AD 1 , in a double - blind, multiple ascending dose (MAD) study, measured by solicited and non - solicited Adverse Events (AEs) in participants with mild to severe AD . Secondary: Compare (NPS) pre and post intervention ne
Slide 26: Phase 1 Trial Design
Phase 1 Trial Design At home - participants with caregivers Mild to severe Alzheimer’s disease, clinical diagnosis Multiple Ascending Dose (MAD) Three dose cohorts - 14 days each cohort with a washout period Dosing: once a day (ǪD), twice a day (BID), and three times a day (TID) Randomized, Double B
Slide 27: Phase 1: Demographics
PHASE 1: Demographics 6G.2% Female 30.8% Male Age: 80.47 “ 5.71 years old Weight (lb): 147.66 “ 31.62 Height (ft): 5.28 “ 0.46 BMI: 21.58 “ 1.02 Science Team 27 NYSEAmerican: IGC - Service to humanity
Slide 28: Genotype and Phenotype for Participants
Genotype and Phenotype for Participants In our study population eight participants out of 13 or about 62% of participants are carriers of at least one polymorphism CYP2C9. Rao J, Gutierrez E, Grimaldi C, Julio W, Shahnawaz SS, Mukunda R. Presented at: AAIC 2023; Amsterdam, Netherlands. Poster No: P3
Slide 29: Phase 1 Trial Safety Results
Phase 1 Trial Safety Results IGC - AD1 was well - tolerated at all three dose levels There were no: Serious Adverse Events (SAEs) Life - threatening AEs Deaths reported Science Team 29 NYSEAmerican: IGC - Service to humanity
Slide 30: Phase 1: Primary Endpoint - Safety & Tolerability
Phase 1: Primary Endpoint - Safety G Tolerability Science Team Mukunda R, Rao J, Gutierrez E, Julio W, Ghazaryan V, Pujals KY, et al. Presented at: 3rd Latinos C Alzheimer’s Symposium; 2022 ; Bonita Springs, FL. Poster No: 35 NYSEAmerican: IGC - Service to humanity 30
Slide 31: Phase 1: Primary Endpoint - Safety & Tolerability (Adverse Events)
Two non - solicited AEs were reported: in Cohort 1, one participant reported a Grade 2 ataxic gait, and in Cohort 2, one participant reported a Grade 2 UTI. One with Grade 3 Hypertension events was unrelated to the IP. Phase 1: Primary Endpoint - Safety G Tolerability Mukunda R, Rao J, Gutierrez E,
Slide 32: Secondary Objective: NPS Measured by NPI-12
Secondary Objective: NPS Measured by NPI - 12 ** 31.5 * 22.2 * 16.0 14.8 12.4 7.9 0 5 10 15 20 25 30 35 40 45 50 Cohort 1 Cohort 2 Cohort 3 Promedio NPI Total Total NPI - 12 Baseline Day 15 Across all three dose levels, IGC - AD1 intervention led to an overall improvement in NPS as measured by the N
Slide 33: Phase 1 Agitation Scores
Phase 1 Agitation Scores Agitation was assessed using the NPI domain score at baseline and at Day 15 (end of treatment) across three dose levels of IGC - AD1 All three doses showed clinical and statistically significant reductions in agitation scores p < 0.05 for each dose group Demonstrates consist
Slide 34: Phase 1 PK Data Shows PK Profile Varies by CYP2C9 Genotype
Phase 1 PK Data Shows PK Profile Varies by CYP2CG Genotype PK data were collected across all participants and stratified based on CYP 450 2 C 9 polymorphisms . As shown in the table IGC - AD1 API half - life increased significantly for intermediate metabolizers over normal metabolizers This genotype
Slide 35: IGC Pharma Poster Presentations at AAIC 2023
IGC Pharma Poster Presentations at the AAIC 2023 in Netherlands Company - owned data NYSEAmerican: IGC - Service to humanity 35
Slide 36: IGC Pharma Poster Presentations at AAIC 2023
IGC Pharma Poster Presentations at the AAIC 2023 in Netherlands Company - owned data NYSEAmerican: IGC - Service to humanity 36
Slide 37: IGC Pharma Poster Presentations at AAIC 2024
IGC Pharma Poster Presentations at the AAIC 2024 in Philadelphia Company - owned data NYSEAmerican: IGC - Service to humanity 37
Slide 38: IGC Pharma Poster Presentations at AAIC 2024
IGC Pharma Poster Presentations at the AAIC 2024 in Philadelphia Company - owned data NYSEAmerican: IGC - Service to humanity 38
Slide 39: IGC Pharma Poster Presentations at AAIC 2024
IGC Pharma Poster Presentations at the AAIC 2024 in Philadelphia Company - owned data NYSEAmerican: IGC - Service to humanity 39
Slide 40: Phase 2 Strategy: Agitation in AD
IGC - AD1 Phase 2 Strategy: Agitation in AD Preclinical studies demonstrated disease modifying potential, including reduction in pTau, Aβ aggregation, and mitochondrial dysfunction. Phase 1 clinical data showed clinical and statistically significant improvements in results agitation symptoms in pati
Slide 41: Phase 2 in Progress
Phase 2, Multi - Center, Double - Blind, Randomized, Placebo - Controlled, Trial of the Safety and Efficacy of IGC - AD1 on Agitation in Participants with Dementia due to Alzheimer’s Disease. Phase 2 in Progress 41 NYSEAmerican: IGC - Service to humanity
Slide 42: What is Agitation in Dementia Due to Alzheimer's Disease?
Agitation refers to a range of behaviors, excessive motor activity, verbal aggression, or physical aggression that is severe enough to impair personal relationships, social functioning, and/or daily activities ( 1 ) . Agitation has a significant impact on both the individuals with Alzheimer's and th
Slide 43: Agitated Behaviors - Categorization based on CMAI Scale
Agitated Behaviors - Categorization based on CMAI* Scale Verbal / Vocal Physical Aggressive Verbally Non - Aggressive o Complaining o Negativism o Repetitive sentences or questions o Constant, unwarranted requests for attention or help Verbally Aggressive o Cursing and verbal aggression o Making str
Slide 44: CALMA Phase 2 Trial: Ongoing Multicenter Randomized Placebo-Controlled Trial
IGC - AD1 CALMA Phase 2 Trial: Ongoing Multicenter, Double Blind, Randomized, Placebo - Controlled Trial Objectives: Primary : evaluate the safety and efficacy of IGC - AD 1 on agitation in AD at week 6 using the CMAI Secondary : Agitation at week 2 using the CMAI Exploratory : AD Blood biomarkers (
Slide 45: CALMA Phase 2 Interim Results: Primary Objective - Week 6
CALMA Phase 2 Interim Results: Primary Objective - Week 6 Cohen d p value LS mean difference (95%CI) 0.79 0.042 - 10.46 ( - 20.53, - 0.4) - 25 - 20 - 15 - 10 - 5 0 0 2 Time - Week 6 LS mean change from baseline CMAI Total Score Placebo n=13 Active n=13 Placebo Active 72.27 68.58 Baseline mean Placeb
Slide 46: CALMA Phase 2 Interim Results: Secondary Objective - Week 2
CALMA Phase 2 Interim Results: Secondary Objective - Week 2 - 20 - 15 - 10 - 5 0 0 2 LS mean change from baseline CMAI Total Score Time - Week Placebo n=13 Active n=13 Placebo IGC - AD1 Δ= - 12.19 p =.071 Cohen d p value LS mean difference (G5%CI) 0.79 0.071 - 12.19 ( - 25.52, 1.14) Company - owned
Slide 47: CALMA Phase 2 Interim Results: Exploratory Objective: Sleep Disturbance
CALMA Phase 2 Interim Results: Exploratory Objective: Sleep Disturbance Treatment led to clinically and statistically significant improvements in sleep disturbance at both week 2 and week 6 - NPI - 12 sleep C nighttime behavior disorder subscale These findings suggest that IGC - AD1 may help improve
Slide 48: CALMA Phase 2 Interim Results: Compared to Brexpiprazole Data
CALMA Phase 2 Interim Results: IGC - AD1 Compared to Brexpiprazole Data Compared to published results of Brexpiprazole, IGC - AD1 appears to be faster acting than Brexpiprazole. IGC - AD1 demonstrates a large effect size (Cohen’s d = 0.79) and is more strongly distinguished from placebo at week 2 an
Slide 49: CALMA Phase 2 Interim Results Adverse Events: vs. Brexpiprazole
CALMA Phase 2 Interim Results Adverse Events: IGC - AD1 vs. Brexpiprazole t Brexpiprazole Trial o ~6% participants had SAEs o 5% participants had AEs leading to discontinuation o 7 deaths reported, 6 in the active group and 1 in placebo IGC - AD1 Trial to date No SAEs reported up to 6 weeks No AEs l
Slide 50: Patent Applications and Granted Patents
We have 31 patent applications in process, which are distributed among the US, Canada, Europe, Colombia, India, Brazil, Japan and Hong Kong and 12 granted Patents in US, Canada, Europe and Mexico. 6 5 4 1 1 1 2 (IGC - LMP) Formulation containing Cobalamin and method for pain management. Pain 1 2 1 4