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What changed in IGC Pharma, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of IGC Pharma, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+284 added−260 removedSource: 10-K (2025-06-27) vs 10-K (2024-06-24)

Top changes in IGC Pharma, Inc.'s 2025 10-K

284 paragraphs added · 260 removed · 170 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

80 edited+63 added−23 removed114 unchanged
Biggest changeOur Business Strategy The business strategy includes: ● Subject to FDA approval and clinical trials, developing IGC-AD1 as a drug for treating agitation in dementia due to Alzheimer’s. ● Subject to FDA approval, developing IGC-AD1 as a drug for treating Alzheimer’s disease. ● Developing TGR-63 for the potential treatment of Alzheimer’s disease. ● Driving revenue from in-house OTC brands and formulations. 5 Table of Contents Core business competencies and advantages Our core competencies include: ● a network of doctors, scientists with Ph.D. degrees, and intellectual property legal experts with a sophisticated understanding of drug discovery, research, FDA filings, intellectual protection, and product formulation; ● knowledge of various cannabinoid strains, their phytocannabinoid profile, extraction methodology, and impact on various pathways; ● knowledge of plant and cannabinoid-based combination therapies; ● knowledge of research and development in the field; ● approximately twenty-eight (28) patent applications out of which our portfolio includes twelve (12) granted patents.
Biggest changeAlthough there can be no assurance, we believe this strategy can improve our existing products and lead to the creation of new products that can provide treatment options for multiple conditions, symptoms, and side effects. 8 Table of Contents Core business competencies and advantages Our core competencies include: ● a network of doctors, scientists with Ph.D. degrees, and intellectual property legal experts with a sophisticated understanding of drug discovery, research, FDA filings, intellectual protection, and product formulation; ● knowledge of various cannabinoid strains, their phytocannabinoids profile, extraction methodology, and impact on various pathways; ● knowledge of plant and cannabinoid-based combination therapies; ● knowledge of research and development in the field; ● approximately thirty-one (31) patent applications out of which our portfolio includes twelve (12) granted patents.
These competencies have enabled us to make progress on our business goals, specifically completing the Phase 1 clinical trial of IGC-AD1, which has the potential to positively impact the lives of millions of patients suffering from the symptoms of Alzheimer’s disease, subject to FDA approval.
These competencies have enabled us to make progress on our business goals, specifically completing the Phase 1 clinical trial of IGC-AD1, which has the potential to positively impact on the lives of millions of patients suffering from the symptoms of Alzheimer’s disease, subject to FDA approval.
Specifically, the pre-clinical research on the TGR-63 showed the following: Impact on plaque levels: Studies in PC12 and SHSY5Y cell lines grown in an AD-like environment have showed TGR-63’s ability in decreasing Aβ plaque levels, leading to an increase in 26% neuron viability (neuronal rescue).
Specifically, the pre-clinical research on TGR-63 showed the following: Impact on plaque levels: Studies in PC12 and SHSY5Y cell lines grown in an AD-like environment have showed TGR-63’s ability in decreasing Aβ plaque levels, leading to an increase in 26% neuron viability (neuronal rescue).
NPS in Alzheimer’s is a significant burden on patients and caregivers, and at some point in the progression of Alzheimer’s disease, more than 97% of patients suffer from at least one symptom. The Neuropsychiatric Inventory (“NPI”) is a scale that measures the severity of each symptom and establishes both individual symptom scores as well as an overall NPI score.
NPS in Alzheimer’s is a significant burden on patients and caregivers, and at some point in the progression of Alzheimer’s disease, more than 97% of patients suffer from at least one symptom. The Neuropsychiatric Inventory (NPI) is a scale that measures the severity of each symptom and establishes both individual symptom scores as well as an overall NPI score.
IGC-AD1 is designed to target AAD’s underlying causes and address the unmet need for a safe and effective therapy. As illustrated in Figure 2, neuroinflammation, neurotransmitter imbalance, and CB1 receptor dysfunctions are all associated with AAD (Yasuno et al., 2023; Manuel et al., 2014).
IGC-AD1 is designed to target AAD’s underlying causes and address the unmet need for safe and effective therapy. As illustrated in Figure 2, neuroinflammation, neurotransmitter imbalance, and CB1 receptor dysfunctions are all associated with AAD (Yasuno et al., 2023; Manuel et al., 2014).
Five-year and three-year exclusivities do not preclude FDA approval of a 505(b)(1) application for a duplicate version of the drug during the period of exclusivity, provided that the 505(b)(1) applicant conducts or obtains a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. 19 Table of Contents Orphan Drug Act Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, generally a disease or condition that affects fewer than 200,000 individuals in the U.S.
Five-year and three-year exclusivities do not preclude FDA approval of a 505(b)(1) application for a duplicate version of the drug during the period of exclusivity, provided that the 505(b)(1) applicant conducts or obtains a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. 23 Table of Contents Orphan Drug Act Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, generally a disease or condition that affects fewer than 200,000 individuals in the U.S.
Behavioral Impact: During the investigation, two groups of APP/PS1 mice undertook an Open-Field (“OF”) test, a behavioral assessment designed to measure aberrant behavior, stress and coping responses, and emotional state, among others, in rodent models.
Behavioral Impact: During the investigation, two groups of APP/PS1 mice undertook an Open-Field (OF) test, a behavioral assessment designed to measure aberrant behavior, stress and coping responses, and emotional state, among others, in rodent models.
Figure 4: TGR-63 also shows high affinity for the Aß42 peptide, compromising its tertiary structure and promoting the formation of globular non-toxic structures that can be metabolized. (*Adv. Therap. 2021, 4 2000225) .
Figure 7: TGR-63 also shows high affinity for the Aß42 peptide, compromising its tertiary structure and promoting the formation of globular non-toxic structures that can be metabolized. (*Adv. Therap. 2021, 4 2000225) .
This can translate to getting the drug to market quicker. ● Breakthrough Therapy Designation ( “ BTD ” ): This designation is given by the FDA to drugs that have the potential to significantly improve treatment for serious or life-threatening conditions.
This can translate to getting the drug to market quicker. ● Breakthrough Therapy Designation (BTD): This designation is given by the FDA to drugs that have the potential to significantly improve treatment for serious or life-threatening conditions.
Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as the imposition of clinical holds, FDA refusal to approve pending New Drug Applications (“NDA”), warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, civil penalties, and criminal prosecution.
Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as the imposition of clinical holds, FDA refusal to approve pending New Drug Applications (NDA), warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, civil penalties, and criminal prosecution.
The CMAI least-squared (“LS”) mean difference at week 6 was -10.46 (95% CI: -20.53 to -0.40) with a Cohen’s d effect size of 0.79 (p= .042), indicating a large and significant IGC-AD1 effect over placebo. Cohen’s d is a standardized statistical effect size that describes the magnitude of the difference between two groups, taking into account the variability in outcomes.
The CMAI least-squared (LS) mean difference at week 6 was -10.46 (95% CI: -20.53 to -0.40) with a Cohen’s d effect size of 0.79 (p= .042), indicating a large and significant IGC-AD1 effect over placebo. Cohen’s d is a standardized statistical effect size that describes the magnitude of the difference between two groups, taking into account the variability in outcomes.
Competitors may use this publicly available information to gain knowledge regarding the design and progress of our development programs. 18 Table of Contents The Hatch-Waxman Act Orange Book Listing In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent the claims of which cover the applicant’s product.
Competitors may use this publicly available information to gain knowledge regarding the design and progress of our development programs. 22 Table of Contents The Hatch-Waxman Act Orange Book Listing In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent the claims of which cover the applicant’s product.
On December 1, 2021, IGC submitted the Clinical/Statistical Report (“CSR”) to the FDA on its Phase 1 trial titled “A Phase I Randomized Placebo-Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 in Subjects with Dementia Due to Alzheimer’s Disease.” The already disclosed data is presented here for a better understanding of the safety profile of IGC-AD1.
On December 1, 2021, IGC submitted the Clinical/Statistical Report (CSR) to the FDA on its Phase 1 trial titled “A Phase I Randomized Placebo-Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 in Subjects with Dementia Due to Alzheimer’s Disease.” The already disclosed data is presented here for a better understanding of the safety profile of IGC-AD1.
However, the continuous aggregation of Aβ proteins along with hyperphosphorylation of tau protein inside the cell, causing NFT formation, are generally accepted as the major etiological factors of the neuronal cell death associated with the progression of Alzheimer’s disease (Octave, 1995; Reitz, et al., 2011; Pillay, et al., 2004). The two hallmarks of Alzheimer’s are shown in Figure 1.
However, the continuous aggregation of Aβ proteins along with hyperphosphorylation of tau protein inside the cell, causing NFT formation, are generally accepted as the major etiological factors of the neuronal cell death associated with the progression of Alzheimer’s disease (Octave, 1995; Reitz, et al., 2011; Pillay, et al., 2004). The two hallmarks of Alzheimer’s are shown in Figure 3.
The 146-patient IGC-AD1 trial, for which these interim results are presented, continues to enroll in the U.S. and Canada. As the interim results are based on a small number of patients (n=26), there is no guarantee that the positive interim results will hold up as more patients are enrolled in the trial.
The 146-patient IGC-AD1 Phase 2 trial, for which these interim results are presented, continues to enroll in the U.S. and Canada. As the interim results are based on a small number of patients (n=26), there is no guarantee that the positive interim results will hold up as more patients are enrolled in the trial.
As an analogy, it is the brick-and-mortar of the highway over which nutrients are transported within a neuron. In an AD brain, tau breaks down due to a process called hyperphosphorylation and is unable to hold the transport highway. The breakdown results in neurofibrillary tangles (“NFTs”) and eventually leads to neuronal death.
As an analogy, it is the brick-and-mortar of the highway over which nutrients are transported within a neuron. In an AD brain, tau breaks down due to a process called hyperphosphorylation and is unable to hold the transport highway. The breakdown results in neurofibrillary tangles (NFTs) and eventually leads to neuronal death.
IGC-AD1 is an oral liquid formulation administered twice daily (“bid”) for six weeks with no placebo run-in and titration to full dose over two days. To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.
IGC-AD1 is an oral liquid formulation administered twice daily (bid) for six weeks with no placebo run-in and titration to full dose over two days. To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.
The Company grew hemp under a license in the state of Arizona. Manufacturing IGC-AD1 from hemp is an extremely inefficient process requiring vast amounts of hemp to manufacture the investigational medication. The regulatory landscape appears to be changing in that the U.S. government is seeking to re-schedule THC from Schedule 1 to Schedule 3.
The Company grew hemp under a license in the state of Arizona. Manufacturing IGC-AD1 from hemp is an extremely inefficient process requiring vast amounts of hemp to manufacture the investigational medication. The regulatory landscape appears to be changing in that the U.S. government is seeking to reschedule THC from Schedule 1 to Schedule 3.
Computational Studies: A Plausible Mode of Action Figure 3: In silico analysis demonstrated that TGR-63 molecular design enables it to interact with amyloid aggregates, disrupting various types of bonds. This destabilizes plaque’s structure, facilitating their breakdown. (*Adv. Therap. 2021, 4 2000225) .
Computational Studies: A Plausible Mode of Action Figure 6: In silico analysis demonstrated that TGR-63 molecular design enables it to interact with amyloid aggregates, disrupting various types of bonds. This destabilizes plaque’s structure, facilitating their breakdown. (*Adv. Therap. 2021, 4 2000225) .
Separately, the NPI also scores caregiver distress (NPI-D). The NPI is used by about 50% of neurologists to assess and treat Alzheimer’s patients (Fernandez et al., 2010). In the Phase 1 trial conducted on patients with Alzheimer’s disease, we measured changes in NPS as assessed by the NPI as well as caregiver distress as assessed by the NPI-D.
Separately, the NPI also scores caregiver distress (NPI-D). The NPI is used by about 50% of neurologists to assess and treat Alzheimer’s patients (Fernandez et al., 2010). In the Phase 1 trial conducted on patients with AD, we measured changes in NPS as assessed by the NPI as well as caregiver distress as assessed by the NPI-D.
The solicited AEs, assessed daily, were somnolence, falls, dizziness, asthenia, suicidal ideation, hypertension, psychiatric symptoms, and paradoxical nausea. All AEs were graded as mild, moderate, severe, life-threatening, and serious (“SAE”). In the phase 1 trial, a) there were no SAEs, b) no life-threatening AEs, and c) no deaths.
The solicited AEs, assessed daily, were somnolence, falls, dizziness, asthenia, suicidal ideation, hypertension, psychiatric symptoms, and paradoxical nausea. All AEs were graded as mild, moderate, severe, life-threatening, and serious (SAE). In the phase 1 trial, a) there were no SAEs, b) no life-threatening AEs, and c) no deaths.
Depending on the risks posed by the drugs, other post-market requirements may be imposed. 17 Table of Contents After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. The FDA approval of the NDA is required before marketing of the product may begin in the U.S.
Depending on the risks posed by the drugs, other post-market requirements may be imposed. 21 Table of Contents After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. The FDA approval of the NDA is required before marketing of the product may begin in the U.S.
Agitation is rated at the trial site, at baseline, week 2, and week 6, by a trained practitioner using the CMAI, a scale designed and widely used to measure agitation in Alzheimer’s dementia (“AAD”) in clinical trials. The IGC-AD1 Phase 2 is an ongoing clinical trial that continues to enroll.
Agitation is rated at the trial site, at baseline, week 2, and week 6, by a trained practitioner using the CMAI, a scale designed and widely used to measure agitation in Alzheimer’s dementia (AAD) in clinical trials. The IGC-AD1 Phase 2 is an ongoing clinical trial that continues to enroll.
Markets and Distribution Life Sciences segment In Fiscal 2024, our Life Sciences segment is focused on the Phase 2 clinical trial for IGC-AD1 and building a pipeline of other assets. In addition, the Company sells over-the-counter products and formulations made in Vancouver, Washington facilities.
Markets and Distribution In Fiscal 2025, our Life Sciences segment is focused on the Phase 2 clinical trial for IGC-AD1 and building a pipeline of other assets. In addition, the Company sells over-the-counter products and formulations made in Vancouver, Washington facilities.
Department of Agriculture’s (“USDA’s”) regulations implementing the Animal Welfare Act. The results of pre-clinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.
Department of Agriculture’s (USDA’s) regulations implementing the Animal Welfare Act. The results of pre-clinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing, and controls, and a proposed clinical trial protocol.
For example, in some patients, low doses may relieve a symptom, whereas high doses may amplify a symptom. IGC’s trial is based on low dosing and controlled trials on patients suffering from Alzheimer’s disease. We conducted a double-blind, single-site, randomized, three-cohort, multiple-ascending dose (“MAD”) clinical trial (FDA IND Number: 146069, NCT04749563) using the investigational new drug (“IND”) IGC-AD1.
For example, in some patients, low doses may relieve a symptom, whereas high doses may amplify a symptom. IGC’s trial is based on low dosing and controlled trials on patients suffering from Alzheimer’s disease. We conducted a double-blind, single-site, randomized, three-cohort, multiple-ascending dose (MAD) clinical trial (FDA IND Number: 146069, NCT04749563) using the investigational new drug (IND) IGC-AD1.
The FDA’s current performance goals call for the FDA to complete a review of 90 percent of standard (non-priority) NDAs within 10 months of receipt and within six months for priority NDAs, but two additional months are added to standard and priority NDAs for a new molecular entity (“NME”).
The FDA’s current performance goals call for the FDA to complete a review of 90 percent of standard (non-priority) NDAs within 10 months of receipt and within six months for priority NDAs, but two additional months are added to standard and priority NDAs for a new molecular entity (NME).
Learn more and find information about recruitment centers at https://clinicaltrials.gov/study/NCT05543681. Figure 2: Damaged and Healthy Neuron IGC-AD1 Clinical Trial Data To the best of our knowledge, the Company’s Phase 2 clinical trial of IGC-AD1 is the first human clinical trial using low doses of THC, in combination with another molecule, to treat symptoms of dementia in Alzheimer’s patients.
Learn more and find information about recruitment centers at https://clinicaltrials.gov/study/NCT05543681. Figure 4: Damaged and Healthy Neurons IGC-AD1 Clinical Trial Data To the best of our knowledge, the Company’s Phase 2 clinical trial of IGC-AD1 is the first human clinical trial using low doses of THC, in combination with another molecule, to treat symptoms of dementia in Alzheimer’s patients.
Available Information The Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Exchange Act are filed with the Securities and Exchange Commission (the “SEC”).
Available Information The Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Exchange Act are filed with the Securities and Exchange Commission (the SEC”).
Pharmaceutical product development in the U.S. typically involves pre-clinical laboratory and animal tests and the submission to the FDA of an Investigational New Drug (“IND”), which must become effective before clinical testing may commence.
Pharmaceutical product development in the U.S. typically involves pre-clinical laboratory and animal tests and the submission to the FDA of an Investigational New Drug (IND), which must become effective before clinical testing may commence.
(*Adv. Therap. 2021, 4 2000225) . Figure 8: During the Morris Water Maze test, mice treated with TGR-63 exhibited improved spatial memory, with decreased latency in finding the target compared to the untreated group. ( *Adv. Therap. 2021, 4 2000225).
(*Adv. Therap. 2021, 4 2000225) . Figure 11: During the Morris Water Maze test, mice treated with TGR-63 exhibited improved spatial memory, with decreased latency in finding the target compared to the untreated group. ( *Adv. Therap. 2021, 4 2000225).
The table below summarizes the nature of the activity, the type of license required and held, and encumbrances in obtaining permits for each location where the Company operated through its subsidiaries in Fiscal 2024: Location Nature of Activity Type of License Required Type of License held Encumbrances in Obtaining Permit U.S.
The table below summarizes the nature of the activity, the type of license required and held, and encumbrances in obtaining permits for each location where the Company operated through its subsidiaries in Fiscal 2025: Location Nature of Activity Type of License Required Type of License held Encumbrances in Obtaining Permit U.S.
Special Protocol Assessment A company may reach an agreement with the FDA under the Special Protocol Assessment (“SPA”), process as to the required design and size of clinical trials intended to form the primary basis of an efficacy claim.
Special Protocol Assessment A company may reach an agreement with the FDA under the Special Protocol Assessment (SPA), process as to the required design and size of clinical trials intended to form the primary basis of an efficacy claim.
Alzheimer's disease (AD) mice displayed a significantly lower DI (-3, p In the MWM test, the time to reach a platform hidden in a pool for four training days showed a remarkable improvement for the TGR-63 treated AD model compared to the AD-vehicle group, indicating enhanced spatial memory, as demonstrated by a significant reduction (~60% reduction; p Figure 7: In the Novel Object Recognition test, mice treated with TGR-63 showed increased exploration of a new object over a familiar one, indicating enhanced learning capacity.
AD mice displayed a significantly lower DI (-3, p In the MWM test, the time to reach a platform hidden in a pool for four training days showed a remarkable improvement for the TGR-63 treated AD model compared to the AD-vehicle group, indicating enhanced spatial memory, as demonstrated by a significant reduction (~60% reduction; p Figure 10: In the Novel Object Recognition test, mice treated with TGR-63 showed increased exploration of a new object over a familiar one, indicating enhanced learning capacity.
Contract Research Organization (CRO) and Clinical Trial Software The IGC-Pharma Electronic Data Capture system (“IGC-EDC”) is a secure and user-friendly data management software designed to collect clinical trial data in electronic format. The software incorporates rigorous security measures that help IGC to protect data and ensure compliance with regulatory requirements and industry standards.
Contract Research Organization (CRO) and Clinical Trial Software The IGC-Pharma Electronic Data Capture system (IGC-EDC) is a secure and user-friendly data management software designed to collect clinical trial data in electronic format. The software incorporates rigorous security measures that help IGC to protect data and ensure compliance with regulatory requirements and industry standards.
As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy (“REMS”) to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use (“ETASU”).
As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy (REMS) to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use (ETASU).
Simplistically, in normal brain functioning, a large protein called Amyloid Precursor Protein (“APP”) is cleaved into smaller fragments called Aβ proteins. In a normal brain, these are subsequently broken down further and cleared.
Simplistically, in normal brain functioning, a large protein called Amyloid Precursor Protein (APP) is cleaved into smaller fragments called Aβ proteins. In a normal brain, these are subsequently broken down further and cleared.
The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years. 14 Table of Contents For patents that might expire during the application phase, the patent owner may request an interim patent extension.
The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years. For patents that might expire during the application phase, the patent owner may request an interim patent extension.
Figure 1: Hallmarks of Alzheimer ’ s ● Extracellular Plaque: β-amyloid (Aβ) ● Tau Neurofibrillary Tangles (NTFs). Causes loss of neurons & critical neuronal connections. Also linked to Alzheimer’s: ● Metabolism disruption ● Mitochondrial dysfunction ● Neuroinflammation 6 Table of Contents Alzheimer’s affects not only cognition but also mood and behavior, changes which increase in intensity as the disease progresses.
Figure 3: Hallmarks of Alzheimer ’ s ● Extracellular Plaque: β-amyloid (Aβ) ● Tau Neurofibrillary Tangles (NTFs). Causes loss of neurons & critical neuronal connections. Also linked to Alzheimer’s: ● Metabolism disruption ● Mitochondrial dysfunction ● Neuroinflammation 9 Table of Contents Alzheimer’s affects not only cognition but also mood and behavior, changes which increase in intensity as the disease progresses.
The investigational drug contains THC, the principal psychoactive cannabinoid found in Cannabis, as one of two active pharmaceutical agents. 9 Table of Contents Pre-Specified Interim Results An experienced third party conducted a protocol pre-specified interim analysis, mean changes from baseline were analyzed using a mixed-effects model for repeated measures (“MMRM”).
The investigational drug contains THC, the principal psychoactive cannabinoid found in Cannabis, as one of two active pharmaceutical agents. 12 Table of Contents Pre-Specified Interim Results An experienced third party conducted a protocol pre-specified interim analysis, mean changes from baseline were analyzed using a mixed-effects model for repeated measures (MMRM).
Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”).
Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application (ANDA).
Regulatory Environment for IGC-AD1 IGC-AD1 is currently made from federally legal hemp and not from federally illegal marijuana. In addition, IGC-AD1 contains the federally legal amount of THC as defined in the 2018 Farm bill. Therefore IGC-AD1 is federally legal based on the amount of THC in the formulation and the origin of the THC.
Regulatory Environment for IGC-AD1 IGC-AD1 is currently made from federally legal hemp In addition, IGC-AD1 contains the federally legal amount of THC as defined in the 2018 Farm Bill. Therefore, IGC-AD1 is federally legal based on the amount of THC in the formulation and the origin of the THC.
Pre-clinical studies of TGR-63 TGR-63 is a patent pending molecule designed to disrupt the structure of the amyloid beta (“Aβ”) plaque, one of the key hallmarks of Alzheimer’s Disease (AD), associated with neuronal toxicity and cognitive decline. TGR-63 targets plaques by inhibiting the aggregation of Aβ42 peptides and destabilizing their tertiary structure.
Pre-clinical studies of TGR-63 TGR-63 is a patent-pending molecule designed to disrupt the structure of the amyloid beta (Aβ) plaque, one of the key hallmarks of AD, associated with neuronal toxicity and cognitive decline. TGR-63 targets plaques by inhibiting the aggregation of Aβ42 peptides and destabilizing their tertiary structure.
We believe that additional investment in clinical trials, research and development (“R&D”), facilities, marketing, advertising, and acquisition of complementary products and businesses will be critical to the ongoing growth of the Life Sciences segment. These investments will fuel the development and delivery of innovative products that drive positive patient and customer experiences.
We believe that additional investment in clinical trials, research and development (R&D), facilities, marketing, advertising, and acquisition of complementary products and businesses will be critical to the ongoing growth of the Life Sciences segment. These investments will fuel the development and delivery of innovative products that drive positive patient and customer experiences.
Background on Alzheimer ’ s Disease Pathology Alzheimer’s disease (“AD”) pathology can be divided into two categories: familial or inherited AD and sporadic AD. The histopathology of early-onset familial AD and late-onset sporadic AD are indistinguishable. Both forms of AD are characterized by extracellular amyloid-β (“Aβ”) plaques and intracellular tau-containing neurofibrillary tangles (Gӧtz, et al., 2011).
Background on Alzheimer ’ s Disease (AD) Pathology AD pathology can be divided into two categories: familial or inherited AD and sporadic AD. The histopathology of early-onset familial AD and late-onset sporadic AD is indistinguishable. Both forms of AD are characterized by extracellular amyloid-β (Aβ) plaques and intracellular tau-containing neurofibrillary tangles (Gӧtz, et al., 2011).
Based on the CMAI interim results shown in Table 2 below, IGC-AD1 demonstrated a clinical and statistically significant agitation reduction compared to placebo in patients with Alzheimer’s disease (“AD”), indicating strong therapeutic potential and meeting the primary endpoint.
Based on the CMAI interim results shown in Table 2 below, IGC-AD1 demonstrated a clinical and statistically significant agitation reduction compared to placebo in patients with AD, indicating strong therapeutic potential and meeting the primary endpoint.
Figure 5 shows the reduction of the amyloid burden by TGR-63 in the APP/PS1 AD mouse model. 11 Table of Contents Figure 5: Reduction of the amyloid burden by TGR-63 in the APP/PS1 AD phenotypic mice model.
Figure 5 shows the reduction of the amyloid burden by TGR-63 in the APP/PS1 AD mouse model. 15 Table of Contents Figure 8: Reduction of the amyloid burden by TGR-63 in the APP/PS1 AD phenotypic mice model.
Phase 1 Secondary Endpoints: Neuropsychiatric Inventory ( “ NPI ” ) Neuropsychiatric Symptoms (“NPS”) such as agitation/aggression, depression, anxiety, elation/euphoria, apathy, disinhibition, irritability, delusions, hallucinations, aberrant motor behavior, sleep disorders, and appetite/eating disorders are prevalent in patients who have Alzheimer’s disease (Phan et al., 2019).
Phase 1 Secondary Endpoints: Neuropsychiatric Inventory (NPI) Neuropsychiatric Symptoms (NPS) such as agitation/aggression, depression, anxiety, elation/euphoria, apathy, disinhibition, irritability, delusions, hallucinations, aberrant motor behavior, sleep disorders, and appetite/eating disorders are prevalent in patients who have AD (Phan et al., 2019).
IGC is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period. IGC has two business segments: Life Sciences Segment and Infrastructure Segment. Please refer to Note 1, “Nature of Operations” and Item 8 of this Annual Report on Form 10-K, for further information on business segments .
ITEM 1. BUSINESS Overview IGC is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period. Please refer to Note 1, “Nature of Operations” and Item 8 of this Annual Report on Form 10-K, for further information on business segments.
The mice in the APP/PS1 group that received TGR-63 treatment showed a 43% reduction in their overall movement within the test area (p Figure 6 Behavioral Tests 12 Table of Contents Impact on memory : The cognitive impact of TGR-63 was assessed using two renowned behavioral tests, the Novel Object Recognition (“NOR”) Test and the Morris Water Maze (“MWM”), conducted on APP/PS1 genetically modified Alzheimer’s mice.
The mice in the APP/PS1 group that received TGR-63 treatment showed a 43% reduction in their overall movement within the test area (p Figure 9 Behavioral Tests 16 Table of Contents Impact on memory : The cognitive impact of TGR-63 was assessed using two renowned behavioral tests, the Novel Object Recognition (NOR) Test and the Morris Water Maze (MWM), conducted on APP/PS1 genetically modified Alzheimer’s mice.
TGR-63, on the other hand, could act as a potential disease-modifying agent to expand the Company’s pursuit of a drug that can treat AD. Figure 3 and Figure 4 show the destabilization of Aβ plaques and Aβ42 peptide with the help of TGR-63.
TGR-63, on the other hand, could act as a potential disease-modifying agent to expand the Company’s pursuit of a drug that can treat AD. Figures 6 and 7: - Show the destabilization of Aβ plaques and Aβ42 peptide with the help of TGR-63.
Please see Item 1A, Risk Factors- “We may not successfully register the provisional patents with the USPTO.” Table 3 below provides the status of our patent filings: Table 3 Patent Filings & Status TARGET DESCRIPTION PATENT PENDING GRANTED PATENTS US FOREIGN Alzheimer’s Disease (IGC-AD1)​ Method & Composition for Treating CNS Disorders​ 14 - 1 Alzheimer’s Disease (IGC-AD1)​ Method & Composition for Treating CNS Disorders​ - 2 - Alzheimer’s Disease (TGR-63) ​ Naphthalene Monoimide Derivatives with the ability to impact Aβ protein build-up 6 - - Alzheimer’s Disease (IGC-1C) Naphthalene Monoimide Derivatives with the ability to impact Tau aggregation and neurofibrillary tangle formation 1 - - Alzheimer’s Disease (IGC-M3) Naphthalene Monoimide Derivatives with the ability to impact Aβ plaque buildup and neurofibrillary tangle formation 1 - - Cancer (Naphthalene Diimdes) Naphthalene diimide Derivatives with the ability to self-assemble molecular interactions for biological and nonbiological systems - 1 1 Alzheimer’s Disease (IGC-LMP) Composition, Synthesis, & Medical use of Hybrid Cannabinoid 1 - - Epilepsy Composition & Method for Treating Seizures in humans & cats/dogs 2 2 - Eating Disorders Cannabis formulation with Cyproheptadine for treating Cachexia & Eating Disorders​ 1 1 - Stuttering & Tourette Syndrome Cannabinoid-Based formulation for Treating Stuttering & Symptoms of Tourette Syndrome 3 - - Pain Cannabinoid-Based Formulation combined with Cobalamin and method for Pain Management 1 2 2 TOTAL 28 8 4 Patent Term Extension After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension.
Table 3 below provides the status of our patent filings: Table 3 Patent Filings & Status TARGET DESCRIPTION PATENT PENDING GRANTED PATENTS US FOREIGN Alzheimer’s Disease (IGC-AD1) Method & Composition for Treating CNS Disorders 12 - 1 Alzheimer’s Disease (IGC-AD1) Method & Composition for Treating CNS Disorders 1 2 - Alzheimer’s Disease (TGR-63) Naphthalene Monoimide Derivatives with the ability to impact Aβ protein build-up 6 - - Alzheimer’s Disease (IGC-1C) Naphthalene Monoimide Derivatives with the ability to impact Tau aggregation and neurofibrillary tangle formation 5 - - Alzheimer’s Disease (IGC-M3) Naphthalene Monoimide Derivatives with the ability to impact Aβ plaque buildup and neurofibrillary tangle formation 4 - - Cancer (Naphthalene Diimdes) Naphthalene Diimide Derivatives with the ability to self-assemble molecular interactions for biological and nonbiological systems - 1 1 Alzheimer’s Disease (IGC-LMP) Composition, Synthesis, & Medical use of Hybrid Cannabinoid 1 - - Epilepsy Composition & Method for Treating Seizures in humans & cats/dogs - 2 - Eating Disorders Cannabis formulation with Cyproheptadine for treating Cachexia & Eating Disorders - 1 - Stuttering & Tourette Syndrome Cannabinoid-Based formulation for Treating Stuttering & Symptoms of Tourette Syndrome 1 - - Pain Cannabinoid-Based Formulation combined with Cobalamin and method for Pain Management 1 2 2 TOTAL 31 8 4 18 Table of Contents Patent Term Extension After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension.
In the Phase 1 trial (N=10), seven received the active medication, and at baseline, they had agitation scores between two and twelve. The three Cohorts shown in Table 1 received the medication once a day (“qd”), twice a day (“bid”) and three times a day (“tid”).
In the Phase 1 trial (N=10), seven received the active medication, and at baseline, they had agitation scores between two and twelve. The three Cohorts shown in Table 1 received the medication once a day (qd), twice a day (bid), and three times a day (tid).
For example, in the state of Arizona, where we grew hemp, we were required to apply for licenses and register with the state the geo-location of all our operations, including the land on which hemp was grown and the facilities where hemp would be processed.
For example, in the state of Arizona, where we grew hemp, we were required to apply for licenses and register with the state the geo-location of all our operations, including the land on which hemp was grown and the facilities where hemp would be processed. These regulations are evolving, differ from jurisdiction to jurisdiction, and are subject to change.
Although there can be no assurance, we believe this strategy can improve our existing products and lead to the creation of new hemp-based products that can provide treatment options for multiple conditions, symptoms, and side effects. We market our in-house brands and the formulations for the products in accordance with applicable laws and regulations.
Although there can be no assurance, we believe this strategy can improve our existing products and lead to the creation of new hemp-based products that can provide treatment options for multiple conditions, symptoms, and side effects.
The data presented here is not exhaustive and represents a small portion of the data submitted to the FDA. 8 Table of Contents Phase 1 Primary Endpoint: Safety & Tolerability Safety and tolerability (“S&T”) was assessed by recording both solicited and non-solicited Adverse Events (“AEs”).
The data presented here is not exhaustive and represents a small portion of the data submitted to the FDA. 11 Table of Contents Phase 1 Primary Endpoint: Safety & Tolerability Safety and tolerability (S&T) were assessed by recording both solicited and non-solicited Adverse Events (AEs).
General business license; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Permits; Fondo Nacional De Estupefacientes (FNE) Permits. None. Canada Clinical Trials Permit from Health Canada to conduct a trial in Canada. Permit to import IGC-AD1 into Canada. Permit to conduct a trial and to import IGC-AD1 into Canada.
Colombia Life Sciences Products and General Management General business license; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Permits; Fondo Nacional De Estupefacientes (FNE) Permits. General business license; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Permits; Fondo Nacional De Estupefacientes (FNE) Permits. None. Canada Clinical Trials Permit from Health Canada to conduct a trial in Canada.
Licenses, Technology, and Cybersecurity We have intellectual property attorneys that advise, counsel, and represent the Company regarding the filing of patents or provisional patent applications, copyright applications, and trademark applications; trade secret laws of general applicability; employee confidentiality and invention assignment.
The study remains ongoing to further assess efficacy, durability, and long-term safety. Licenses, Technology, and Cybersecurity We have intellectual property attorneys that advise, counsel, and represent the Company regarding the filing of patents or provisional patent applications, copyright applications, and trademark applications; trade secret laws of general applicability; employee confidentiality and invention assignment.
TGR-63 and Alzheimer ’ s disease Researchers at the Jawaharlal Nehru Centre for Advanced Scientific Research (“JNCASR”), in India, conducted approximately 10 years of research on Naphthalene Monoimide (“NMI”) compounds and the activity of NMI compounds on neurotoxicity associated with Alzheimer’s Disease (AD). 10 Table of Contents In Alzheimer’s patients, neurotoxicity is linked to beta-amyloid (“Aβ”) plaques and Neuro Fibrillary Tangles (“NFT”).
Researchers at the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), in India, conducted approximately 10 years of research on Naphthalene Monoimide (NMI) compounds and the activity of NMI compounds on neurotoxicity associated with AD. 14 Table of Contents In Alzheimer’s patients, neurotoxicity is linked to beta-amyloid (Aβ) plaques and Neuro Fibrillary Tangles (NFT).
Currently, IGC-AD1 is in a Phase 2 clinical trial, and on March 20, 2024, IGC announced the “Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s agitation”.
Currently, IGC-AD1 is in a Phase 2 clinical trial, and on March 20, 2024, and on November 14, 2024, IGC announced the “Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s agitation” and “Additional Phase 2 Interim Results Highlighting Cognitive Benefits of IGC-AD1 for Alzheimer’s Treatment”, respectively.
The NIA categorizes Alzheimer’s in three stages–- mild, moderate, and severe (NIA, 2019). Symptoms of mild Alzheimer’s can include wandering (getting lost, not remembering the way home), trouble handling money and paying bills, repeating questions, and personality or behavior changes.
Agitation in Alzheimer’s dementia has been associated with increased caregiver burden, decreased functioning, earlier nursing home placement, and death. The NIA categorizes Alzheimer’s in three stages- mild, moderate, and severe (NIA, 2019). Symptoms of mild Alzheimer’s can include wandering (getting lost, not remembering the way home), trouble handling money and paying bills, repeating questions, and personality or behavior changes.
The National Institute on Aging (“NIA”) at the National Institutes of Health (“NIH”) defines Alzheimer’s disease (“AD”) as an irreversible, progressive brain disorder that destroys memory and thinking skills. AD is a progressive neurodegenerative disorder that manifests initially as forgetfulness, advancing to severe cognitive impairment and memory loss.
The National Institute on Aging (NIA) at the National Institutes of Health (NIH) defines AD as an irreversible, progressive brain disorder that destroys memory and thinking skills. AD is a progressive neurodegenerative disorder that manifests initially as forgetfulness, advancing to severe cognitive impairment and memory loss. Emotional distress, aggressive behaviors, disruptive irritability, and disinhibition characterize agitation.
Third-party payors may not consider our product candidates to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. 20 Table of Contents Human Capital Management and Environment, Health, and Safety Workplace Safety & Employee Care During COVID-19 .
Third-party payors may not consider our product candidates to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. 24 Table of Contents Human Capital Management and Environment, Health, and Safety Human Capital Management We believe that our ability to attract, retain, and develop exceptional talent is critical to our success, particularly in advancing our clinical development programs and scientific research.
The interim data validates IGC-AD1’s potential as a transformative therapeutic option with a large market opportunity in Alzheimer’s disease management, although there can be no assurance. 7 Table of Contents IGC-AD1 as a Treatment for Agitation in Alzheimer ’ s Dementia In 2023, the number of Americans living with Alzheimer’s was estimated at 6.7 million.
The interim data validates IGC-AD1’s potential as a transformative therapeutic option with a large market opportunity in Alzheimer’s disease management, although there can be no assurance. 10 Table of Contents IGC-AD1 as a Treatment for Agitation in Alzheimer ’ s Dementia Approximately 6.9 million Americans aged 65 and older are living with Alzheimer’s dementia, according to the Alzheimer’s Association’s 2024 Facts and Figures report.
Life Sciences Products and General Management General business License to grow hemp; Industrial Alcohol User Permit; Clinical Trials; Good Manufacturing Practices (GMP) certification. FDA approval to run a trial General business licenses; Industrial Alcohol User Permit; FDA approval to run a trial. None.
Life Sciences Products and General Management General business Clinical Trials; Good Manufacturing Practices (GMP) certification. FDA approval to run a trial General business licenses; Industrial Alcohol User Permit; FDA approval to run a trial. None. India Infrastructure Contract, Rental of heavy equipment, and land General business license Business registrations with tax authorities in various states in India None.
None Governmental Regulations In the U.S., we are subject to oversight and regulations, for some or all of our activities, by the following agencies: SEC, state regulators, NYSE, FTC, and the FDA. The cannabis plant consists of several strains or varieties. Hemp and Marijuana are both cannabis plants.
Permit to import IGC-AD1 into Canada. Permit to conduct a trial and to import IGC-AD1 into Canada. None 20 Table of Contents Governmental Regulations In the U.S., we are subject to oversight and regulations, for some or all of our activities, by the following agencies: SEC, state regulators, NYSE, FTC, FINRA, and the FDA. Hemp is cannabis plant.
Under the 2018 Farm Bill, Hemp is classified as a cannabis plant that has 0.3% or less THC by dry weight. Marijuana is classified as a cannabis plant that has THC above 0.3% by dry weight.
Under the 2018 Farm Bill, Hemp is classified as a cannabis plant that has 0.3% or less THC by dry weight. The 2018 Farm Bill, which was effective January 1, 2019, contains provisions that make industrial hemp, defined as a cannabis plant that has 0.3% of less THC by dry weight, legal.
NPS like agitation, apathy, delusions, hallucinations, and sleep impairment are common accompaniments of dementia. Loss of functionality, including progressive difficulty in performing instrumental and basic activities of daily living, is also seen with disease progression (Tang et al., 2019). There is a spectrum of behavioral disorders that can affect patients with AD.
Loss of functionality, including progressive difficulty in performing instrumental and basic activities of daily living, is also seen with disease progression (Tang et al., 2019). There is a spectrum of behavioral disorders that can affect patients with AD. These include agitation, anxiety, disturbance of the sleep cycle, depression, inappropriate sexual behavior, disinhibition, and irritability, among others (Lyketsos, et al., 2011).
Our Life Sciences revenue is less than 1% of the relevant global market, which implies a tremendous opportunity for growth. In Fiscal 2024, our sales and suppliers were concentrated, which represents some risk. Two customers accounted for over 10% of sales. Infrastructure segment In Fiscal 2024, our infrastructure business is focused on executing a project in the state of Kerala.
Our Life Sciences revenue is less than 1% of the relevant global market, which implies a good opportunity for growth. In Fiscal 2025, our sales and suppliers were concentrated, which represents some risk. Two customers individually accounted for over 10% of total sales. Competition Overview Our industry is highly competitive and subject to rapid and significant technological change.
These regulations are evolving, differ from jurisdiction to jurisdiction, and are subject to change. 16 Table of Contents FDA Approval Process In the U.S., pharmaceutical products are subject to extensive regulation by the FDA.
FDA Approval Process In the U.S., pharmaceutical products are subject to extensive regulation by the FDA.
We believe this strategic move should enable us to reduce the costs associated with clinical trials compared to relying on external CROs, although there can be no assurance.
We believe this strategic move should enable us to reduce the costs associated with clinical trials compared to relying on external CROs, although there can be no assurance. Intellectual Property IGC Pharma, is committed to building a strong and defensible intellectual property (IP) portfolio that supports our strategic focus on neurodegenerative diseases and related therapeutic areas.
These disturbances can become very difficult to manage, so most of the time, combinational therapy is used (Matsunaga, et al., 2015).
These behavioral disturbances not only affect the patient’s quality of life but also cause extreme emotional distress for the caregivers. These disturbances can become very difficult to manage, so most of the time, combined therapy is used (Matsunaga et al., 2015).
Branded wellness and lifestyle products to be sold in multiple retail and online channels, subject to applicable federal, state, and local laws and regulations. 3. Partnerships and licensing agreements with third parties who can accelerate bringing our IP to the market. The Company holds all rights to the patents that it filed with the USPTO.
Branded wellness and lifestyle products, offered through retail and online distribution channels, in compliance with applicable federal, state, and local laws. 3. Partnerships and licensing agreements with third parties to accelerate product development and market entry. We hold exclusive rights to all patents filed with the U.S. Patent and Trademark Office (USPTO).
Table 2 Interim CMAI Results for Week 2 and Week 6 Week 2 Week 6 (EOT) Scale LS Mean Change (95% CI) p value Cohen's d LS Mean Change (95% CI) p value Cohen's d CMAI -12.19 (-25.52, 1.14) .071 0.79 -10.46 (-20.53, -0.4) .042 0.79 Existing Treatments for Agitation in Alzheimer ’ s Dementia In May 2023, the U.S.
Table 2:- Interim CMAI Results for Week 2 and Week 6 Week 2 Week 6 (EOT) Scale LS Mean Change (95% CI) p value Cohen’s d LS Mean Change (95% CI) p value Cohen’s d CMAI -12.19 (-25.52, 1.14) .071 0.79 -10.46 (-20.53, -0.4) .042 0.79 IGC-AD1 Clinical Trial Interim Data Demonstrates Significant Reduction in Sleep Disturbances As part of an interim analysis, the Company observed statistically and clinically significant reductions in sleep disturbances, as measured by the Neuropsychiatric Inventory (NPI-12) Sleep Subscale.
Approximately 6.5 million individuals in the U.S. live with Alzheimer’s, and a majority experience a medical syndrome called agitation in Alzheimer’s dementia. There are various symptoms associated with this medical syndrome or condition, such as screaming, pacing, biting, disrobing, excessive motor movements, physical aggression, and verbal aggression, among others.
There are various symptoms associated with this medical condition, such as screaming, pacing, biting, disrobing, excessive motor movements, physical aggression, and verbal aggression, among others. These behaviors make up clinical agitation in dementia due to Alzheimer’s disease and it they make it very difficult for caregivers to manage their loved ones.
We are building a robust pipeline of five drug candidates, each targeting different aspects of the disease. ● IGC-AD1 : Our lead investigational drug tackles agitation, a major burden for patients and caregivers.
Our Drug Development Pipeline IGC Pharma is on a mission to transform Alzheimer’s treatment. We are building a robust pipeline of drug candidates, each targeting different aspects of the disease.
Life Sciences segment : We are aware of other companies working to develop therapeutics for the treatment of AAD, including Axsome Therapeutics, Inc., which is working to develop a combination of dextromethorphan and bupropion, and Otsuka and Lundbeck A/S, which recently received approval for Rexulti for this indication. We face competition from well-funded pharmaceutical companies.
Competition for the Company’s investigational medications, products, and services: We are aware of other companies working to develop therapeutics for the treatment of AAD, including Axsome Therapeutics, Inc., which is working to develop a combination of dextromethorphan and bupropion, and Otsuka and Lundbeck A/S, which recently received approval for Rexulti for this indication. 19 Table of Contents Interim data from our Phase 2 trial of IGC-AD1 for agitation in Alzheimer’s disease show a statistically significant improvement in symptoms compared to placebo over six weeks, as measured by the Cohen-Mansfield Agitation Inventory (CMAI).
Al., 2006). Background on Agitation in Alzheimer ’ s dementia We are currently developing IGC-AD1 for the treatment of agitation in Alzheimer’s dementia (“AAD”). There is only one FDA-approved pharmacological treatment for the indication of AAD.
While there can be no guarantee, we expect the Phase 2 trial to take between 12 and 18 months to complete, barring a variety of unknown factors. We are currently developing IGC-AD1 for the treatment of Agitation in Alzheimer’s dementia (AAD). There is only one FDA-approved pharmacological treatment for the indication of AAD.
Pharmaceutical products that are subject to FDA approvals. We currently have one Alzheimer’s symptom- modifying investigational drug candidate (IGC-AD1) in Phase 2 clinical trials under an INDA filed with the FDA and a potential Alzheimer’s disease modifying drug development candidate (TGR-63) in a pre-clinical stage. 2.
We aim to commercialize our intellectual property through multiple channels: 1. Pharmaceutical products are subject to U.S. Food and Drug Administration (FDA) approval. Our lead candidate, IGC-AD1, is currently in a Phase 2 clinical trial for treating agitation in AD. We are also developing TGR-63, a pre-clinical candidate with potential disease-modifying effects in Alzheimer’s. 2.
We are also harnessing the power of Artificial Intelligence (“AI”) to develop early detection models, optimize clinical trials, and explore new applications for our drugs. Additionally, our 28 patent filings, including for IGC-AD1, demonstrates our commitment to innovation and protecting our intellectual property.
Additionally, our 31 patent filings, including for IGC-AD1, demonstrate our commitment to innovation and protecting our intellectual property. Artificial Intelligence (AI)/Machine Learning (ML) In our pursuit of innovation, we leverage AI and ML. AI refers to the development of intelligent systems that can learn and act autonomously.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn addition, we are subject to the risks of new or enhanced governmental or regulatory scrutiny, litigation, or other legal liability, ethical concerns, negative consumer perceptions as to automation and AI, or other complications that could adversely affect our business, reputation, or financial results. 21 Table of Contents As a result of the complexity and rapid development of AI, it is also the subject of evolving review by various U.S. governmental and regulatory agencies, and other foreign jurisdictions are applying, or are considering applying, their platform moderation, intellectual property, cybersecurity, and data protection laws to AI and/or are considering general legal frameworks on AI.
Biggest changeAs a result of the complexity and rapid development of AI, it is also the subject of evolving review by various U.S. governmental and regulatory agencies, and other foreign jurisdictions are applying, or are considering applying, their platform moderation, intellectual property, cybersecurity, and data protection laws to AI and/or are considering general legal frameworks on AI.
For example, these transactions may entail numerous operational and financial risks, including: 22 Table of Contents ● exposure to unknown or unanticipated liabilities, including foreign laws with which we are unfamiliar; ● disruption of our business and diversion of our management’s time and attention to develop acquired products, product candidates, or technologies; ● the incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions, which we may not be able to obtain on favorable terms, if at all; ● higher than expected acquisition and integration costs; ● write-downs of assets or goodwill or impairment charges; ● increased amortization expenses; ● difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; ● entering a long-term relationship with a partner that proves to be unreliable or counterproductive; ● impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and ● inability to retain key employees of any acquired businesses.
For example, these transactions may entail numerous operational and financial risks, including: ● exposure to unknown or unanticipated liabilities, including foreign laws with which we are unfamiliar; 26 Table of Contents ● disruption of our business and diversion of our management’s time and attention to develop acquired products, product candidates, or technologies; ● the incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions, which we may not be able to obtain on favorable terms, if at all; ● higher than expected acquisition and integration costs; ● write-downs of assets or goodwill or impairment charges; ● increased amortization expenses; ● difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; ● entering a long-term relationship with a partner that proves to be unreliable or counterproductive; ● impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and ● inability to retain key employees of any acquired businesses.
As a result, the control share acquisition statute could discourage offers to acquire our common stock and could increase the difficulty of completing an offer. 33 Table of Contents Board of Directors The Maryland General Corporation Law provides that a Maryland corporation which is subject to the Exchange Act and has at least three outside directors (who are not affiliated with an acquirer of the company) under certain circumstances may elect by resolution of the board of directors or by amendment of its charter or bylaws to be subject to statutory corporate governance provisions that may be inconsistent with the corporation’s charter and bylaws.
As a result, the control share acquisition statute could discourage offers to acquire our common stock and could increase the difficulty of completing an offer. 37 Table of Contents Board of Directors The Maryland General Corporation Law provides that a Maryland corporation which is subject to the Exchange Act and has at least three outside directors (who are not affiliated with an acquirer of the company) under certain circumstances may elect by resolution of the board of directors or by amendment of its charter or bylaws to be subject to statutory corporate governance provisions that may be inconsistent with the corporation’s charter and bylaws.
However, the circumstances under which a single adequate and controlled study can be used as the sole basis for demonstrating the efficacy of a drug are exceptional. 25 Table of Contents The FDA or any foreign regulatory bodies can delay, limit, or deny approval of our product candidates or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including: ● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ● the FDA or comparable foreign regulatory authorities may disagree with our safety interpretation of our drug; ● the FDA or comparable foreign regulatory authorities may disagree with our efficacy interpretation of our drug; ● the FDA or comparable foreign regulatory authorities may regard our Chemistry Manufacturing and Controls package as inadequate.
However, the circumstances under which a single adequate and controlled study can be used as the sole basis for demonstrating the efficacy of a drug are exceptional. 29 Table of Contents The FDA or any foreign regulatory bodies can delay, limit, or deny approval of our product candidates or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including: ● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ● the FDA or comparable foreign regulatory authorities may disagree with our safety interpretation of our drug; ● the FDA or comparable foreign regulatory authorities may disagree with our efficacy interpretation of our drug; and ● the FDA or comparable foreign regulatory authorities may regard our Chemistry Manufacturing and Controls package as inadequate.
The results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. 26 Table of Contents If unacceptable side effects arise in the development of our product candidates, we, the FDA, or the IRBs at the institutions in which our studies are conducted, or the DSMB, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications.
The results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. 30 Table of Contents If unacceptable side effects arise in the development of our product candidates, we, the FDA, or the IRBs at the institutions in which our studies are conducted, or the DSMB, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications.
While we monitor a broad range of ESG matters, we cannot be certain that we will manage such matters successfully or that we will successfully meet the expectations of investors, employees, consumers, governments, and other stakeholders. 31 Table of Contents Risks Related to ownership of our common stock: Future sales of common stock by us could cause our stock price to decline and dilute your ownership in our Company.
While we monitor a broad range of ESG matters, we cannot be certain that we will manage such matters successfully or that we will successfully meet the expectations of investors, employees, consumers, governments, and other stakeholders. 35 Table of Contents Risks Related to ownership of our common stock: Future sales of common stock by us could cause our stock price to decline and dilute your ownership in our Company.
These procedures may limit the ability of stockholders to bring business before a stockholders meeting, including the nomination of directors and the consideration of any transaction that could result in a change in control and that may result in a premium to our stockholders. 34 Table of Contents Our executive officers and large shareholders concentrated insider ownership of our common stock, which will limit your influence on corporate matters.
These procedures may limit the ability of stockholders to bring business before a stockholders meeting, including the nomination of directors and the consideration of any transaction that could result in a change in control and that may result in a premium to our stockholders. 38 Table of Contents Our executive officers and large shareholders concentrated insider ownership of our common stock, which will limit your influence on corporate matters.
As such, it is not possible to predict all of the risks related to the use of AI, and changes in laws, rules, directives, and regulations governing the use of AI may adversely affect our ability to develop and use AI or subject us to legal liability. Our cannabinoid strategy makes it difficult to raise money as a public company.
As such, it is not possible to predict all of the risks related to the use of AI, and changes in laws, rules, directives, and regulations governing the use of AI may adversely affect our ability to develop and use AI or subject us to legal liability. Our cannabinoid medication makes it difficult to raise money as a public company.
The market price of shares of our common stock has fluctuated substantially in recent years and is likely to fluctuate significantly from its current level. Our common stock has also been volatile, with our 52-week closing price range being at a low of $0.27 and a high of $0.46 per share.
The market price of shares of our common stock has fluctuated substantially in recent years and is likely to fluctuate significantly from its current level. Our common stock has also been volatile, with our 52-week closing price range being at a low of $0.27 and a high of $0.69 per share.
Any modification, amendment, or reformulation of information contained in such reports could be significant and result in material liability to us and have a material and adverse impact on the trading price of our common stock. 32 Table of Contents We do not anticipate declaring any cash dividends on our common stock.
Any modification, amendment, or reformulation of information contained in such reports could be significant and result in material liability to us and have a material and adverse impact on the trading price of our common stock. 36 Table of Contents We do not anticipate declaring any cash dividends on our common stock.
Investors should be aware of the potential risks associated with this process and its potential impact on our financial performance before investing in our company. 30 Table of Contents The Company is exposed to the risk of write-downs on the value of its inventory and other assets, in addition to purchase commitment cancellation risk.
Investors should be aware of the potential risks associated with this process and its potential impact on our financial performance before investing in our company. 34 Table of Contents The Company is exposed to the risk of write-downs on the value of its inventory and other assets, in addition to purchase commitment cancellation risk.
This, in turn, may have a material and adverse impact on the trading price of our common stock. 28 Table of Contents We may be unable to protect our intellectual property rights and/or intellectual property rights licensed to us and may be subject to intellectual property litigation and infringement claims by third parties.
This, in turn, may have a material and adverse impact on the trading price of our common stock. 32 Table of Contents We may be unable to protect our intellectual property rights and/or intellectual property rights licensed to us and may be subject to intellectual property litigation and infringement claims by third parties.
We could also encounter delays if a clinical trial is suspended or terminated by us, the IRBs or IECs of the institutions in which such trials are being conducted, the Data Safety Monitoring Board (“DSMB”), for such trial or the FDA or other regulatory authorities.
We could also encounter delays if a clinical trial is suspended or terminated by us, the IRBs or IECs of the institutions in which such trials are being conducted, the Data Safety Monitoring Board (DSMB), for such trial or the FDA or other regulatory authorities.
These facts could cause reputational harm, loss of customers, or loss of future business, thereby reducing our revenue. 29 Table of Contents Our suppliers and distributors and their third-party service providers hold customer data, some of which is hosted in third-party facilities.
These facts could cause reputational harm, loss of customers, or loss of future business, thereby reducing our revenue. 33 Table of Contents Our suppliers and distributors and their third-party service providers hold customer data, some of which is hosted in third-party facilities.
Clinical trials can be delayed or terminated for a variety of reasons, including but not limited to: ● the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies; ● obtaining regulatory approval to commence a trial; ● reaching an agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● obtaining Institutional Review Board (“IRB”) approval at each site or Independent Ethics Committee (“IEC”) approval at sites outside the United States; 24 Table of Contents ● recruiting suitable patients to participate in a trial in a timely manner and in sufficient numbers; ● having patients complete a trial or return for post-treatment follow-up; ● imposition of a clinical hold by regulatory authorities, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere to regulatory requirements or follow trial protocols; ● clinical sites deviating from trial protocol or dropping out of a trial; ● addressing patient safety concerns that arise during the course of a trial; ● adding a sufficient number of clinical trial sites; or ● manufacturing sufficient quantities of the product candidate for use in clinical trials.
Clinical trials can be delayed or terminated for a variety of reasons, including but not limited to: ● the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies; ● obtaining regulatory approval to commence a trial; ● reaching an agreement on acceptable terms with prospective contract research organizations (CROs), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● obtaining Institutional Review Board (IRB) approval at each site or Independent Ethics Committee (IEC) approval at sites outside the United States; 28 Table of Contents ● recruiting suitable patients to participate in a trial in a timely manner and in sufficient numbers; ● having patients complete a trial or return for post-treatment follow-up; ● imposition of a clinical hold by regulatory authorities, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere to regulatory requirements or follow trial protocols; ● clinical sites deviating from trial protocol or dropping out of a trial; ● addressing patient safety concerns that arise during the course of a trial; ● adding a sufficient number of clinical trial sites; or ● manufacturing sufficient quantities of the product candidate for use in clinical trials.
Failure to supply our partners with commercial products may lead to adverse consequences. Climate change concerns could disrupt our businesses, adversely affect client activity levels, adversely affect the creditworthiness of our counterparties, and damage our reputation.
Failure to supply our partners with commercial products may lead to adverse consequences. 31 Table of Contents Climate change concerns could disrupt our businesses, adversely affect client activity levels, adversely affect the creditworthiness of our counterparties, and damage our reputation.
We may be subject to various privacy and security regulations, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by The Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, including the related final published omnibus rule.
We may be subject to various privacy and security regulations, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by The Health Information Technology for Economic and Clinical Health Act (HITECH), and their respective implementing regulations, including the related final published omnibus rule.
We may not successfully register the provisional patents with the USPTO. We have filed twenty-eight (28) patent applications with the USPTO and also in other different countries in the combination therapy space for the indications of pain, Alzheimer’s, medical refractory epilepsy, eating disorders, and Tourette syndrome as part of our intellectual property strategy focused on the phytocannabinoid-based health care industry.
We may not successfully register the provisional patents with the USPTO. We have filed thirty-one (31) patent applications with the USPTO and also in other different countries in the combination therapy space for the indications of pain, Alzheimer’s, medical refractory epilepsy, eating disorders, and Tourette syndrome as part of our intellectual property strategy focused on the phytocannabinoid-based health care industry.
While we do not, and do not intend, to distribute or sell marijuana in the U.S., it is unclear whether regulatory authorities in the U.S. would object to the registration or public offering of securities in the U.S. by our Company to the status of our Company as a reporting company, or even to investors investing in our Company, if we engage in legal cannabinoids cultivation and supply pursuant to the laws and authorization of the jurisdiction where the activity takes place.
It is unclear whether regulatory authorities in the U.S. would object to the registration or public offering of securities in the U.S. by our Company; the status of our Company as a reporting company; or investors investing in our Company, if we engage in legal cannabinoids cultivation and supply pursuant to the laws and authorization of the jurisdiction where the activity takes place.
If we cannot achieve profitability, the market price of our common stock could decline significantly. As of March 31, 2024, we had cash and cash equivalents of $1.2 million and working capital of approximately $1.4 million compared to cash and cash equivalents of $3.2 million and working capital of $4.6 million as of March 31, 2023, for continuing operations.
If we cannot achieve profitability, the market price of our common stock could decline significantly. As of March 31, 2025, we had cash and cash equivalents of approximately $405 thousand and working capital of approximately $639 thousand compared to cash and cash equivalents of $1.2 million and working capital of $1.4 million as of March 31, 2024, for continuing operations.
If trade restrictions or tariffs reduce global economic activity, potential impacts could include declining sales, increased costs, volatility in foreign exchange rates, a decline in the value of our financial assets and pension plan investments, required increases of our pension funding obligations, increased government cost control efforts, delays or failures in the performance of customers, suppliers and other third parties on whom we may depend for the performance of our business, and the risk that our allowance for doubtful accounts may not be adequate.
If trade restrictions or tariffs reduce global economic activity, potential impacts could include declining sales, increased costs, volatility in foreign exchange rates, a decline in the value of our financial assets and pension plan investments, required increases of our pension funding obligations, increased government cost control efforts, delays or failures in the performance of customers, suppliers and other third parties on whom we may depend for the performance of our business, and the risk that our allowance for doubtful accounts may not be adequate. 27 Table of Contents Legal claims could be filed that may have a material adverse effect on our business, operating results, and financial condition.
Global Operations We operate on a global scale and could be affected by currency fluctuations, capital and exchange controls, global economic conditions including inflation, expropriation, and other restrictive government actions, changes in intellectual property legal protections and remedies, trade regulations, tax laws, and regulations, and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including but not limited to the current conflict between Russia and Ukraine, terrorist activity, unstable governments, and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.
Global Operations We currently operate in the U.S., Canada, Colombia, and India, and buy raw materials and equipment from China, and our operations and expenses could be affected by currency fluctuations, capital and exchange controls, economic conditions including inflation, expropriation, and other restrictive government actions, changes in intellectual property legal protections and remedies, trade regulations, tax laws, and regulations, and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including but not limited to the current conflicts, terrorist activity, unstable governments, and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.
Marijuana and hemp plants are both the same species, the dioecious plant Cannabis sativa L. Most countries differentiate hemp from marijuana by the amount of THC. Under the 2018 Farm Bill, hemp is classified as a cannabis plant that has 0.3% or less THC by dry weight.
Within the species Cannabis sativa L, most countries define hemp by the amount of THC. Under the 2018 Farm Bill, hemp is classified as a cannabis plant that has 0.3% or less THC by dry weight.
There are significant risks involved in developing and deploying AI, and there can be no assurance that the usage of AI will enhance our products or services or be beneficial to our business, including our efficiency or profitability.
In particular, we expect our AI initiatives will require increased investment in infrastructure and headcount. 25 Table of Contents There are significant risks involved in developing and deploying AI, and there can be no assurance that the usage of AI will enhance our products or services or be beneficial to our business, including our efficiency or profitability.
Government financing and economic pressures can lead to negative pricing pressure in various markets where governments take an active role in setting prices, access criteria (e.g., through health technology assessments), or other means of cost control. We continue to monitor the global trade environment and potential trade conflicts and impediments that could impact our business.
Government financing and economic pressures can lead to negative pricing pressure in various markets where governments take an active role in setting prices, access criteria (e.g., through health technology assessments), or other means of cost control.
Violations of financial regulation laws are subject to civil and, in some cases, criminal sanctions. We may not have been, or may not be, or may be alleged to have not been or to not be, at all times, in complete compliance with all requirements, and we may incur costs or liabilities in connection with such requirements or allegations.
We may not have been, or may not be, or may be alleged to have not been or to not be, at all times, in complete compliance with all requirements, and we may incur costs or liabilities in connection with such requirements or allegations.
Despite having no direct involvement in selling marijuana, the Company is often incorrectly classified as a “cannabis company” or a “marijuana company,” with all the nuances that accompany that label, including being blacklisted by banks, investment banks, and until recently by the largest stock clearing services company.
Despite deriving IGC-AD1 from legal hemp, the Company is often incorrectly classified as a “cannabis company”, with all the nuances that accompany that label, including being blacklisted by banks, investment banks, and until recently by the largest stock clearing services company.
If such an event were to occur, it could have an adverse effect on our business and financial results. Potential Risks Associated with the Disposal of Non-Core Assets Investing in our company may be subject to risks related to the disposal of our non-core assets.
If such an event were to occur, it could have an adverse effect on our business and financial results. Potential Risks Associated with the Disposal of Non-Core Assets While our current focus is on advancing our Life Sciences business, we continue to own certain non-core assets, including infrastructure-related properties and equipment.
The extent of such exposure can be difficult or impossible to estimate, which can negatively impact our financial condition and results of operations. Our operations are subject to numerous laws and regulations in the U.S., India, Colombia, and Hong Kong relating to the protection of the public and necessary disclosures regarding financial services. Liability under these laws involves inherent uncertainties.
Our operations are subject to numerous laws and regulations in the U.S., India, and Colombia, relating to the protection of the public and necessary disclosures regarding financial services. Liability under these laws involves inherent uncertainties. Violations of financial regulation laws are subject to civil and, in some cases, criminal sanctions.
We are making investments in AI initiatives, including generative AI, to, among other things, recommend relevant unconnected content across our products, enhance our advertising tools, develop new products, and develop new features for existing products. In particular, we expect our AI initiatives will require increased investment in infrastructure and headcount.
We may not be successful in our artificial intelligence initiatives, which could adversely affect our business, reputation, or financial results. We are making investments in AI initiatives, including generative AI, to, among other things, recommend relevant unconnected content across our products, enhance our advertising tools, develop new products, and develop new features for existing products.
As of June 18, 2024, our executive officers and largest shareholders beneficially owned 31.48% based on 75,636,419 outstanding shares of common stock.
As of June 20, 2025, our executive officers and largest shareholders beneficially owned 21.01% based on 83,891,586 outstanding shares of common stock.
Some emerging market countries may be particularly vulnerable to periods of financial or political instability or significant currency fluctuations or may have limited resources for healthcare spending. As a result of these and other factors, our strategy to grow in emerging markets may not be successful, and growth rates in these markets may not be sustainable.
India, and Colombia may be particularly vulnerable to periods of financial or political instability or significant currency fluctuations or may have limited resources for healthcare spending.
While our decision to dispose of these non-core assets is aimed at monetizing non-core assets, streamlining operations, and optimizing resource allocation, the process carries certain risks that may negatively impact our financial performance.
We have not made a formal decision to dispose of these assets, other than “Asset held for sale”. Our decision to dispose of these non-core assets is aimed at monetizing non-core assets, streamlining operations, and optimizing resource allocation.
Any problems in our growing or manufacturing process could have a material adverse effect on our business, results of operations, and financial condition.
Any of these factors could negatively affect our business, financial condition, or results of operations.
If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance, or achievements may vary materially from any future results, performance, or achievements expressed or implied by these forward-looking statements. Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.
Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.
These possible sanctions would adversely affect our business, the results of operations, and financial condition. 23 Table of Contents Legal claims could be filed that may have a material adverse effect on our business, operating results, and financial condition. We may, in the future, face risks of litigation and liability claims.
We may, in the future, face risks of litigation and liability claims. The extent of such exposure can be difficult or impossible to estimate, which can negatively impact our financial condition and results of operations.
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We have had a history of operating losses. For Fiscal 2024 and Fiscal 2023, we had a net loss of approximately $13 million and $11.5 million, respectively. Our revenue increased from Fiscal 2023 to Fiscal 2024. Our short-term focus is to gain market share for our Life Sciences segment.
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We have had a history of operating losses. Our net losses decreased by approximately $6 million from $13 million in Fiscal 2024 to approximately $7.1 million in Fiscal 2025. We expect to continue incurring substantial expenses as we advance the clinical development of IGC-AD1 and our other product candidates.
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Accordingly, there can be no guarantee that our efforts will be successful. If our revenues do not grow or if our operating expenses continue to increase, we may not be able to become profitable, and the market price of our common stock could decline. If we continue to have losses, we will be required to seek additional financing.
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Our ability to achieve or sustain profitability depends on our success in developing, obtaining regulatory approval for, and commercializing our product candidates, which is highly uncertain and subject to significant risks.
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No assurance can be given that we can raise any such financing, and such financing could be dilutive to our shareholders. We may not be successful in our artificial intelligence initiatives, which could adversely affect our business, reputation, or financial results.
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If we fail to achieve profitability or improve our financial condition, our ability to raise additional capital may be limited, and the market price of our common stock could decline significantly. Additionally, continued losses could impact our ability to maintain compliance with applicable stock exchange listing requirements.
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Marijuana is classified as a cannabis plant that has THC above 0.3% by dry weight. Both marijuana and hemp produce other cannabinoids, such as CBD. CBD, mentioned in the context of products, refers to hemp extracts naturally rich in cannabinoids like CBD but with 0.3% or less THC by dry weight.
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In addition, we are subject to the risks of new or enhanced governmental or regulatory scrutiny, litigation, or other legal liability, ethical concerns, negative consumer perceptions as to automation and AI, or other complications that could adversely affect our business, reputation, or financial results.
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The Drug Enforcement Administration ( “ DEA ” ) interim final rule related to statutory amendments to the Controlled Substances Act made by the Agriculture Improvement Act of 2018 ( “ AIA ” ) regarding the scope of regulatory controls over marijuana, tetrahydrocannabinols, and other related constituents may have an adverse impact on our Company.
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We continue to monitor the global trade environment, especially with China and the countries we operate in, and potential trade conflicts and impediments that could impact our business.
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Effective August 21, 2020, the interim rule to align DEA regulations in response to hemp legalization under the 2018 Farm Bill became effective. In order to meet the AIA’s definition of hemp and thus qualify for the exception in the definition of marijuana, a cannabis-derived product must itself contain 0.3% or less delta-9-Tetrahydrocannabinol (“THC”) on a dry weight basis.
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However, if we decide to proceed with a sale, divestiture, or shutdown in the future, we may face various risks, including: ● Impairment charges or write-downs that could negatively impact our financial results and stockholders’ equity; ● Costs related to the termination of leases, contracts, or employee arrangements; ● Challenges in finding suitable buyers or partners, potentially resulting in unfavorable pricing or delayed transactions; ● Regulatory or legal risks associated with asset disposal, including environmental, labor, or tax compliance matters; ● Distraction of management’s attention from our core Life Sciences operations.
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It is not enough that a product is labeled or advertised as “hemp.” Cannabis-derived products that exceed the 0.3% THC limit do not meet the statutory definition of “hemp” and are Schedule I controlled substances, regardless of claims made to the contrary in the labeling or advertising of the products.
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Further, a cannabis derivative, extract, or product that exceeds the 0.3% THC limit is a Schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less THC on a dry weight basis. While we strive to ensure compliance, further tightening of these definitions may have an adverse impact on our products.
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The Company depends on the performance of carriers, wholesalers, retailers, and other resellers. The Company distributes its products through wholesalers, retailers, and resellers, many of whom may distribute products from competing manufacturers.
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The Company also intends to sell its products and resell third-party products in most of its major markets directly to consumers, small and mid-sized businesses, and other customers through its retail and online stores and its direct sales force.
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The Company intends to invest in programs to enhance reseller sales, including staffing selected resellers’ stores with Company employees and contractors and improving product placement displays. These programs can require a substantial investment while not assuring return or incremental sales.
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The financial condition of these resellers could weaken, these resellers could stop distributing the Company’s products, or uncertainty regarding demand for some or all of the Company’s products could cause resellers to reduce their ordering and marketing of the Company’s products.
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We may fail to expand our growing and manufacturing capability in time to meet market demand for our products and product candidates, and the FDA may refuse to accept our facilities or those of our contract manufacturers as being suitable for the production of our products and product candidates.
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In addition, before we can begin commercial manufacture of any medicinal product candidates for sale in the U.S., we must obtain FDA regulatory approval for the product, which requires a successful FDA inspection of the manufacturing facilities, which in turn includes the facilities of the processor(s) and quality systems in addition to other product-related approvals.
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Due to the complexity of the processes used to manufacture our product candidates, we may be unable to initiate or continue to pass federal, state, or international regulatory inspections in a cost-effective manner.
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If we are unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products, total or partial suspension of production, and/or enforcement actions, including injunctions and criminal or civil prosecution.
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The nature of our products, customer base, and sales channels cause us to lack visibility regarding future demand for our products, which makes it difficult for us to predict our revenues or operating results. It is important to the success of our business that we have the ability to accurately predict the future demand for our products.
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However, several factors contribute to a lack of visibility with respect to future orders, including: ● the lengthy and unpredictable sales cycle for our products that can extend from 6 to 24 months or longer; ● the project-driven nature of our customers’ requirements; ● the uncertainty of the extent and timing of market acceptance of our new products; ● the requirement to obtain industry certifications or regulatory approval for some products; and ● the diversity of our product lines and the geographic scope of our product distribution.
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This lack of visibility impacts our ability to forecast inventory requirements. An overestimate of our customers’ future requirements for products may lead to excess inventory, which would increase costs and potentially require us to write-off inventory that becomes obsolete.
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If we underestimate our customers’ future requirements, we may have inadequate inventory, which could interrupt and delay the delivery of our products to our customers and could cause our revenues to decline.
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If any of these events occur, they could negatively impact our revenues, which could prevent us from achieving or sustaining profitability. 27 Table of Contents Some, but not all, of the factors that could affect our ability to achieve results are described in forward-looking statements.
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The Company owns land in Nagpur with a book value of approximately $720 thousand and other assets in Cochin, India, and Vancouver, Washington totaling about $500 thousand that are not core to our pharmaceutical business focus.
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The sale of these assets could result in a potential financial loss, that is approximately the difference between the book value reflected on the balance sheet and the sale price. Market conditions, negotiation challenges, and external factors beyond our control could result in realizing a sale price significantly lower than the book value reflected on the balance sheet.
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The carrying costs of maintaining these non-core assets until their sale incur holding costs, including property taxes and maintenance expenses, and these costs could also negatively impact our financial performance. Additionally, the disposal process may involve temporary disruptions to certain infrastructure operations. However, we are actively managing the disposal process to mitigate these risks and maximize shareholder value.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeDuring Fiscal year ended March 31, 2024, we did not identify any cybersecurity threats that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition. However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced undetected cybersecurity incidents.
Biggest changeWe are committed to transparency and will provide updates on any material cybersecurity incidents that may impact our company or our stakeholders. During Fiscal year ended March 31, 2025, we did not identify any cybersecurity threats that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition.
Our IT Lead is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, communicating key priorities to relevant personnel, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports. 35 Table of Contents Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including the CEO, who help the Company mitigate and remediate cybersecurity incidents of which they are notified.
Our IT Lead is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, communicating key priorities to relevant personnel, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports. 39 Table of Contents Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including the CEO, who help the Company mitigate and remediate cybersecurity incidents of which they are notified.
Our IT Lead has 11 years of experience in roles that include oversight of cybersecurity risk management programs. In addition, the IT Lead is assisted by an external agency with about 8 years of expertise in cybersecurity.
Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our IT Lead. Our IT Lead has 5 years of experience in roles that include oversight of cybersecurity risk management programs. In addition, the IT Lead is assisted by an external agency with about 15 years of expertise in cybersecurity.
Although there can be no assurance, that our cybersecurity program will prevent all incidents. In the event of a cybersecurity incident, we have established procedures for prompt investigation, containment, and remediation to minimize the impact on our operations and stakeholders.
In the event of a cybersecurity incident, we have established procedures for prompt investigation, containment, and remediation to minimize the impact on our operations and stakeholders.
The board of directors’ audit committee is responsible for overseeing Company’s cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats. Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our IT Lead.
Governance Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function. The board of directors’ audit committee is responsible for overseeing Company’s cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats.
We believe that our cybersecurity program is robust and effective, and we will continue to invest in and improve our capabilities to address evolving threats. We are committed to transparency and will provide updates on any material cybersecurity incidents that may impact our company or our stakeholders.
We believe that our cybersecurity program is robust and effective, and we will continue to invest in and improve our capabilities to address evolving threats, although there can be no assurance, that our cybersecurity program will prevent all incidents.
For additional information about these risks, see Part I, Item 1A, “Risk Factors” in this Annual Report on Form 10-K. Governance Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function.
However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced undetected cybersecurity incidents. For additional information about these risks, see Part I, Item 1A, “Risk Factors” in this Annual Report on Form 10-K.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn addition, we own and have short-term lease facilities in the U.S. and India that are used for sales, storage accounting, management, and R&D. We own approximately 5 acres of land in India. The Company believes its existing facilities and equipment, which are used by all reportable segments, are in good operating condition and suitable for conducting its business.
Biggest changeIn addition, we own and have short-term lease facilities in the U.S. and India that are used for sales, storage, accounting, management, and R&D. The Company believes its existing facilities and equipment, which are used by all reportable segments, are in good operating condition and suitable for conducting its business.
ITEM 2. PROPERTIES Our corporate headquarters is located in Potomac, Maryland. We own approximately 40,000 square feet of property used for general management and R&D operations. In addition, we are leasing, through December 2025, approximately 16,000 square feet in Vancouver, Washington, for manufacturing, sales, and distribution of our Life Sciences segment products and services.
ITEM 2. PROPERTIES Our corporate headquarters is located in Potomac, Maryland. We own approximately 40,000 square feet of property used for general management and R&D operations. In addition, we are leasing, through September 2025, approximately 16,000 square feet in Vancouver, Washington, for manufacturing, sales, and distribution of our Life Sciences segment products and services.
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We own approximately 5 acres of land in India, classified as “Asset Held for Sale” as on March 31, 2025. Please refer, Note 6 – “Property, Plant and Equipment”, for more information on Part II, Item 8.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeIn December 2023, the case was reviewed by the investigator and scheduled and accepted for a hearing by the prosecutor in calendar 2024. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 36 Table of Contents PART II
Biggest changeIn December 2023, the case was reviewed by the investigator and scheduled and accepted for a hearing by the prosecutor in calendar 2024. During the fiscal year ended 2025, the Company met with the prosecutors and pressed the urgency of moving the case through the legal system. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 40 Table of Contents PART II
ITEM 3. LEGAL PROCEEDINGS The Company may be involved in legal proceedings, claims, and assessments arising in the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There are no such matters that are deemed material to the consolidated financial statements as of March 31, 2024.
ITEM 3. LEGAL PROCEEDINGS The Company may be involved in legal proceedings, claims, and assessments arising in the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance.
As a result of the settlement, the court dismissed the case in its entirety on October 6, 2023. Engineering and Consulting Group SAS et al. v IGC Pharma Inc ., case file no. 110016000050202247710 (Prosecutor's Office 393 Sectional Economic Crimes Unit, Bogota, Colombia). The Company and the ECG corporation are in a contractual dispute.
As of March 31, 2025, the following material litigation is pending: Engineering and Consulting Group SAS et al. v IGC Pharma Inc ., case file no. 110016000050202247710 (Prosecutor’s Office 393 Sectional Economic Crimes Unit, Bogota, Colombia). The Company and the ECG corporation are in a contractual dispute.
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As of March 31, 2024, the Company and one of its officers are parties to the following litigation matters: Apogee Financial Investments, Inc., et al. v. India Globalization Capital, Inc., et al., Civil Action No. 1:21-cv-03809 (U.S. District Court for the Southern District of New York). On April 29, 2021, Apogee Financial Investments, Inc. (Apogee) and John R.
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Clarke (Clarke) filed a complaint against the Company and IGC’s President and Chief Executive Officer, Ram Mukunda (Mukunda) (the Apogee Litigation). The litigation was originally initiated by IGC on February 8, 2021 (India Globalization Capital, Inc. v. Apogee Financial Investments, Inc., Civil Action No. 1:21-cv-01131, U.S.
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District Court for the Southern District of New York), wherein IGC alleged that Apogee breached a purchase agreement dated December 18, 2014, related to IGC’s intended purchase of a business known as Midtown Partners & Co., LLC (Midtown). In response to the original lawsuit filed by IGC, Apogee and Clarke filed a counterclaim as well as the Apogee Litigation.
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On June 28, 2021, Apogee and Clarke filed an amended complaint/counterclaim. On July 23, 2021, IGC and Mukunda moved to partially dismiss the counterclaim and the Apogee Litigation.
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On March 7, 2022, the Court granted the motion to dismiss in substantial part, leaving only two claims: Apogee’s cross-claim against the Company for an alleged breach of the purchase agreement; and Clarke’s claim against the Company for an alleged breach of an alleged promise to issue him shares of the Company.
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On June 24, 2022, Apogee and Clarke filed a second amended complaint/counterclaim asserting the same claims. On February 21, 2023, IGC and Mukunda filed a motion for summary judgment seeking judgment on both IGC’s underlying Complaint against Apogee and Apogee’s and Clarke’s claims against Apogee and Mukunda. On April 19, 2023, Apogee and Clarke filed a response to the motion.
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Both Apogee and Clarke withdrew their claims against Mukunda at that time. The Company filed its reply in support of summary judgment on May 16, 2023.
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On July 20, 2023, the court granted the motion for summary judgment in substantial part, ruling (a) that Apogee breached the parties’ purchase agreement, (b) that Clarke’s claims were barred by the applicable statute of limitations, (c) that Apogee breached a contract related to a loan made by IGC to Apogee in 2015 and that IGC is entitled to damages and interest as a result; and (d) that all claims against Mukunda are dismissed.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeShares are intended to be exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), by virtue of the provisions of Section 4(a)(2) of the Securities Act and Regulation D and/or Regulation S adopted thereunder. 37 Table of Contents Purchases of equity securities by the issuer and affiliated purchasers None. ITEM 6. [RESERVED]
Biggest changeThe investment is subject to customary closing conditions, including NYSE approval. As per the 2025 SPA, the investor received piggyback registration rights subject to certain restrictions. Shares are intended to be exempt from registration under the Securities Act, by virtue of the provisions of Section 4(a)(2) of Securities Act. Purchases of equity securities by the issuer and affiliated purchasers None.
Further information on the securities can be referred to in Note 13, “Securities” of Part II, Item 8. Securities authorized for issuance under equity compensation plans The following table shows, as of March 31, 2024, information regarding outstanding awards available under our compensation plans (including individual compensation arrangements) under which our equity securities may be delivered.
Further information on the securities can be referred to in Note 13, “Securities” of Part II, Item 8. Securities authorized for issuance under equity compensation plans The following table shows, as of March 31, 2025, information regarding outstanding awards available under our compensation plans (including individual compensation arrangements) under which our equity securities may be delivered.
(2) Consists of 2 million shares as a special grant of common stock, as approved by our stockholders on January 7, 2020, 2.5 million shares as a special grant of common stock, as approved by our stockholders on January 11, 2021, 3.5 million shares as a special grant of common stock, as approved by our stockholders on October 15, 2021, 3 million shares as a special grant of common stock, as approved by stockholders on September 9, 2022, and 3 million shares as special grant of common stock, as approved by stockholders on August 18, 2023.
(2) Consists of 2 million shares as a special grant of common stock, as approved by our stockholders on January 7, 2020, 2.5 million shares as a special grant of common stock, as approved by our stockholders on January 11, 2021, 3.5 million shares as a special grant of common stock, as approved by our stockholders on October 15, 2021, 3 million shares as a special grant of common stock, as approved by stockholders on September 9, 2022, 3 million shares as special grant of common stock, as approved by stockholders on August 18, 2023 and 5 million shares as special grant of common stock, as approved by stockholders on August 23, 2024.
Holders of Record As of June 18, 2024, we had approximately 44 registered shareholders of record of our common stock and 2 registered unit holders. The number of record holders does not include persons who held our common stock in nominee or “street name” accounts through brokers.
Holders of Record As of June 20, 2025, we had approximately 46 registered shareholders of record of our common stock and 2 registered unit holders. The number of record holders does not include persons who held our common stock in nominee or “street name” accounts through brokers.
Plan category (a) Number of securities to be issued upon exercise of outstanding options, warrants and rights (in thousands) (b) Weighted- average exercise price of outstanding options, warrants and rights (c) Number of securities available for future issuance (excluding shares in column (a) (in thousands) Equity compensation plans approved by security holders: 2018 Omnibus Incentive Plan (1) 3,217 $ 0.28 - Special Grant (2) 8,056 $ 0.57 - (1) Consists of our 2018 Omnibus Incentive Plans, as approved by our stockholders on November 8, 2017.
Plan category (a) Number of securities to be issued upon exercise of outstanding options, warrants and rights (in thousands) (b) Weighted- average exercise price of outstanding options, warrants and rights (c) Number of securities available for future issuance (excluding shares in column (a) (in thousands) Equity compensation plans approved by security holders: 2018 Omnibus Incentive Plan (1) 2,106 $ 0.34 1,821 Special Grant (2) 9,203 $ 0.51 4,224 (1) Consists of our 2018 Omnibus Incentive Plans, as approved by our stockholders on November 8, 2017.
We currently anticipate that we will retain future earnings, if any, for the development, operation, and expansion of our business and do not anticipate declaring or paying any dividends in the foreseeable future. Any future determinations related to the dividend policy will be made at the discretion of our Board of Directors.
We currently anticipate that we will retain future earnings, if any, for the development, operation, and expansion of our business and do not anticipate declaring or paying any dividends in the foreseeable future.
Removed
Unregistered sales of equity securities On March 22, 2024, the Company entered into a Share Purchase Agreement (the “SPA”) with Bradbury Strategic Investment Fund A, resulting in approximately $3 million in gross proceeds. The completion of the private placement is subject to customary closing conditions, including approval by the NYSE.
Added
Any future determinations related to the dividend policy will be made at the discretion of our Board of Directors. 41 Table of Contents Unregistered sales of equity securities In the first quarter of Fiscal 2026, the Company entered into a Share Purchase Agreement (the 2025 SPA) with multiple investors, relating to the sale and issuance by our company to investors of an aggregate of 2,803,333 shares of our common stock, for a total purchase price of $841,000, or $0.30 per share, subject to the terms and conditions set forth in the 2025 SPA.
Removed
Under the terms of the private placement, IGC will issue approximately 8.8 million shares of unregistered common stock at a price of $0.34 per share. In addition, the Company will issue 2 million shares of unregistered common stock for consulting services related to raising capital, including the March 2024 capital raised.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

36 edited+43 added−33 removed19 unchanged
Biggest change(in thousands, audited) As of March 31, 2024 ($) As of March 31, 2023 ($) Change ($) Percent Change Cash, cash equivalents 1,198 3,196 (1,998 ) (63 )% Working capital 1,365 4,568 (3,203 ) (70 )% 41 Table of Contents Cash and cash equivalents Cash and cash equivalents decreased by approximately $2 million to $1.2 million in Fiscal 2024 from $3.2 million in Fiscal 2023, a decrease of approximately 63% is discussed in the summary of cash flows, as follows: (in thousands, audited) Fiscal 2024 ($) 2023 ($) Change ($) Percent Change Cash used in operating activities (5,199 ) (7,047 ) 1,848 (26 )% Cash used in investing activities (317 ) (235 ) (82 ) 35 % Cash provided by financing activities 3,524 100 3,424 3,424 % Effects of exchange rate changes on cash and cash equivalents (6 ) (82 ) 76 (93 )% Net decrease in cash and cash equivalents (1,998 ) (7,264 ) 5,266 (72 )% Cash and cash equivalents at the beginning of the period 3,196 10,460 (7,264 ) (69 )% Cash and cash equivalents at the end of the period 1,198 3,196 (1,998 ) (63 )% Operating Activities Net cash used in operating activities for Fiscal 2024 was approximately $5.2 million.
Biggest changeThis is discussed in the summary of cash flows, as follows: (in thousands, audited) Fiscal 2025 ($) 2024 ($) Change ($) Percent Change Cash used in operating activities (4,794 ) (5,199 ) 405 (8 )% Cash used in investing activities (442 ) (317 ) (126 ) 40 % Cash provided by financing activities 4,451 3,524 927 26 % Effects of exchange rate changes on cash and cash equivalents (7 ) (6 ) (1 ) 14 % Net decrease in cash and cash equivalents (792 ) (1,998 ) 1,206 (60 )% Cash and cash equivalents at the beginning of the period 1,198 3,196 (1,998 ) (63 )% Cash and cash equivalents at the end of the period 405 1,198 (792 ) (66 )% 47 Table of Contents Operating Activities Net cash used in operating activities for Fiscal 2025 was approximately $4.8 million.
Investing Activities Net cash used in investing activities for Fiscal 2024, was approximately $317 thousand, which comprises approximately $377 thousand for the acquisition and development of intangible assets, approximately $94 thousand from the net purchase of property, plant, and equipment, and approximately $154 thousand from a short-term investment.
Net cash used in investing activities for Fiscal 2024, was approximately $317 thousand, which comprises approximately $377 thousand for the acquisition and development of intangible assets, approximately $94 thousand from the net purchase of property, plant, and equipment, and approximately $154 thousand from a short-term investment.
The Company does not have any material long-term debt, capital lease obligations, or other long-term liabilities except as disclosed in this report. Please refer to Note 12, “Commitments and contingencies”, Note 11, “Loans and Other Liabilities,” and Note 9, “Leases” in Item 1 of this report for further information on Company commitments and contractual obligations.
The Company does not have any material long-term debt, capital lease obligations, or other long-term liabilities except as disclosed in this report. Please refer to Note 12, “Commitments and contingencies”, Note 11, “Loans and Other Liabilities,” and Note 9, “Leases” in Item 1 of this report for further information on the Company’s commitments and contractual obligations.
ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following is a discussion and analysis of the consolidated statement of operations, liquidity, and capital resources, and a summary of cash flows, which apply to Fiscal 2024, ending on March 31, 2024, and Fiscal 2023, ending on March 31, 2023.
ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following is a discussion and analysis of the consolidated statement of operations, liquidity, and capital resources, and a summary of cash flows, which apply to Fiscal 2025, ending on March 31, 2025, and Fiscal 2024, ending on March 31, 2024.
During Fiscal 2024, the Company has begun working on overlaying machine learning technologies and Artificial Intelligence (“AI”) into the internal clinical trial software framework for trial management with the expectation that this can lead to improved decision-making, contextual data entry, computational models, trial design (Phase 3), and data analysis, the company believes it is probable that the project will be completed and the software will be used to perform the function intended.
During Fiscal 2024, the Company began working on overlaying machine learning technologies and Artificial Intelligence (AI) into the internal clinical trial software framework for trial management with the expectation that this can lead to improved decision-making, contextual data entry, computational models, trial design (Phase 3), and data analysis, the company believes it is probable that the project will be completed and the software will be used to perform the function intended.
Financing Activities Net cash provided by financing activities was approximately $3.5 million for Fiscal 2024, which comprises net proceeds from the issuance of equity stock of approximately $3.5 million and re-payment of a long-term loan of approximately $3 thousand.
Financing Activities Net cash provided by financing activities was approximately $4.4 million for Fiscal 2025, which comprises net proceeds from the issuance of equity stock of approximately $4.4 million and re-payment of a long-term loan of approximately $3 thousand.
As a result, changes in the relative values of the U.S. Dollar (“USD”), the INR, the HKD, or the COP affect financial statements. The accompanying financial statements are reported in USD. The INR, HKD, and COP are the functional currencies for certain subsidiaries of the Company.
As a result, changes in the relative values of the U.S. Dollar (USD), the INR, or the COP affect financial statements. 50 Table of Contents The accompanying financial statements are reported in USD. The INR, and COP are the functional currencies for certain subsidiaries of the Company.
Impairment loss on Property, Plant, and Equipment ( “ PPE ” ) – During Fiscal 2024, as the Company focused on liquidating all non-operating assets to reduce the cost and generate cash, the Company impaired the land situated in Nagpur, India, by approximately $3.3 million to $720 thousand from $4.1 million.
During Fiscal 2024, as the Company focused on liquidating all non-operating assets to reduce the cost and generate cash, the Company impaired the land situated in Nagpur, India, by approximately $3.3 million to $720 thousand from $4.1 million.
It consists of a net loss of approximately $13 million, a positive impact on cash due to non-cash expenses of approximately $5.9 million, and changes in operating assets and liabilities of approximately $1.9 million.
Net cash used in operating activities for Fiscal 2024 was approximately $5.2 million. It consists of a net loss of approximately $13 million, a positive impact on cash due to non-cash expenses of approximately $5.9 million, and changes in operating assets and liabilities of approximately $1.9 million.
The Company capitalized approximately $405 thousand in software development costs. Please refer to Note 5, “Intangible Assets,” for more information. Foreign currency translation IGC operates in India, U.S., Colombia, and Hong Kong, and a substantial portion of the Company’s financials are denominated in the Indian Rupee (“INR”), the Hong Kong Dollar (“HKD”), or the Colombian Peso (“COP”).
As of Fiscal year ended 2025, the Company capitalized approximately $863 thousand in software development costs. Please refer to Note 5, “Intangible Assets,” for more information. Foreign currency translation IGC operates in India, U.S., and Colombia, and a substantial portion of the Company’s financials are denominated in the Indian Rupee (INR), or the Colombian Peso (COP).
The exchange rates used for translation purposes are as follows: Period End Average Rate Period End Rate Period (P&L rate) (Balance sheet rate) Year ended March 31, 2024 INR 82.79 Per USD INR 83.38 Per USD HKD 7.8 Per USD HKD 7.8 Per USD COP 4,114 Per USD COP 3,862 Per USD Year ended March 31, 2023 INR 80.32 Per USD INR 82.18 Per USD HKD 7.8 Per USD HKD 7.8 Per USD COP 4,465 Per USD COP 4,645 Per USD 44 Table of Contents Cybersecurity We have a cybersecurity policy in place and have implemented tighter cybersecurity measures to safeguard against hackers.
The exchange rates used for translation purposes are as follows: Period End Average Rate Period End Rate Period (P&L rate) (Balance sheet rate) Year ended March 31, 2025 INR 84.54 Per USD INR 85.45 Per USD COP 4,140.74 Per USD COP 4,200 Per USD Year ended March 31, 2024 INR 82.79 Per USD INR 83.38 Per USD COP 4,114 Per USD COP 3,862 Per USD Cybersecurity We have a cybersecurity policy in place and have implemented tighter cybersecurity measures to safeguard against hackers.
Other Income, net – During Fiscal 2024, the Company reported approximately $143 thousand in other income, which represents an increase of approximately $78 thousand as compared to the $65 thousand recorded in Fiscal 2023. The increase in other income is attributable to profit from the sale of assets.
Other Income, net – During Fiscal 2025, the Company reported approximately $325 thousand in other income, which represents an increase of approximately $182 thousand as compared to the $143 thousand recorded in Fiscal 2024. The increase in other income is attributable to the tax credit of $194 thousand.
Net cash provided by financing activities was approximately $0.1 million for Fiscal 2023, which comprises net proceeds from the issuance of equity stock through the ATM offering, net of all expenses related to the issuance of stock. 42 Table of Contents Critical Accounting Policies and Estimates The preparation of financial statements and related disclosures in conformity with U.S.
Net cash provided by financing activities was approximately $3.5 million for Fiscal 2024, which comprises net proceeds from the issuance of equity stock of approximately $3.5 million and re-payment of a long-term loan of approximately $3 thousand. 48 Table of Contents Critical Accounting Policies and Estimates The preparation of financial statements and related disclosures in conformity with U.S.
If property, plant, and equipment are considered to be impaired, an impairment loss is recognized. During Fiscal 2024, as the Company focused on liquidating all non-operating assets to reduce costs and generate cash, the Company impaired the land situated in Nagpur, India, by approximately $3.3 million to $720 thousand from $4.1 million.
During Fiscal 2024, as the Company focused on liquidating all non-operating assets to reduce costs and generate cash, the Company impaired the land situated in Nagpur, India, by approximately $3.3 million to $720 thousand from $4.1 million. The Company believes it can sell the above-said non-operating land as it is without any improvement.
Net cash used in operating activities for Fiscal 2023 was approximately $7 million. It consists of a net loss of approximately $11.5 million, a positive impact on cash due to non-cash expenses of approximately $3.7 million, and changes in operating assets and liabilities of approximately $0.8 million.
It consists of a net loss of approximately $7.1 million, a positive impact on cash due to non-cash expenses of approximately $2.3 million, and changes in operating assets and liabilities of approximately $70 thousand.
This generally occurs upon our delivery to a third-party carrier or to the customer directly. Revenue from white label services is recognized when the performance obligation has been completed and output material has been transferred to the customer.
Revenue from white label services is recognized when the performance obligation has been completed and output material has been transferred to the customer.
The consideration/price for the transaction (performance obligation(s)) is determined as per the agreement or invoice (contract) for the services and products in the Infrastructure and Life Sciences segment. Revenue in the Infrastructure segment is recognized for the renting business when the equipment is rented and the terms of the agreement have been fulfilled during the period.
The consideration/price for the transaction (performance obligation(s)) is determined as per the agreement or invoice (contract) for the services and products Life Sciences segment. In the Life Sciences segment, the revenue from the wellness and lifestyle business is recognized once goods have been sold to the customer and the performance obligation has been completed.
In addition, changes in operating assets and liabilities had a positive impact of approximately $0.8 million on cash, of which approximately $0.9 million is due to an adjustment in inventory and approximately $0.1 million decrease in other net current assets and liabilities.
In addition, changes in operating assets and liabilities had a positive impact of approximately $70 thousand on cash, of which approximately $180 thousand is due to an adjustment in inventory, approximately $107 thousand increase in accounts payable, approximately $187 decrease in deposit and advances, approximately $195 thousand decrease in accrued and other current liabilities, approximately $100 thousand increase in operating lease assets, and approximately $75 thousand increase in other net current assets.
The increase in R&D expenses is primarily attributed to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on TGR-63, indicating the Company’s dedication to advancing its product pipeline. As the development of TGR-63 and the Phase 2 trial on Alzheimer’s gain momentum, the Company anticipates further increases in R&D expenses.
In Fiscal 2025, the Company reported R&D expenses of approximately $3.7 million, representing a decrease of $118 thousand or 3% compared to approximately $3.8 million in Fiscal 2024. The R&D expenses is primarily attributed to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on TGR-63, indicating the Company’s dedication to advancing its product pipeline.
Results of Operations Fiscal 2024 compared to Fiscal 2023 The following table presents an overview of our results of operations for Fiscal 2024 and Fiscal 2023: Statement of Operations (in thousands, audited) Fiscal 2024 ($) 2023 ($) Change ($) Percent Change Revenue 1,345 911 434 48 % Cost of revenue (612 ) (469 ) (143 ) 30 % Gross profit 733 442 291 66 % Selling, general and administrative expenses (6,758 ) (8,552 ) 1,794 (21 )% Research and development expenses (3,773 ) (3,461 ) (312 ) 9 % Operating loss (9,798 ) (11,571 ) 1,773 (15 )% Impairment Loss on PPE (3,345 ) - (3,345 ) - Other income, net 143 65 78 120 % Loss before income taxes (13,000 ) (11,506 ) (1,494 ) 13 % Income tax expense/benefit - - - - Net loss attributable to common stockholders (13,000 ) (11,506 ) (1,494 ) 13 % Revenue – During Fiscal 2024, the Company generated approximately $1.3 million in revenue, representing an increase from the $911 thousand generated in Fiscal 2023.
Results of Operations Fiscal 2025 compared to Fiscal 2024 The following table presents an overview of our results of operations for Fiscal 2025 and Fiscal 2024: Statement of Operations (in thousands, audited) Fiscal 2025 ($) 2024 ($) Change ($) Percent Change Revenue 1,271 1,345 (74 ) (6 )% Cost of revenue (652 ) (612 ) (40 ) 7 % Gross profit 619 733 (114 ) (16 )% Selling, general, and administrative expenses (4,410 ) (6,758 ) 2,348 (35 )% Research and development expenses (3,655 ) (3,773 ) 118 (3 )% Operating loss (7,446 ) (9,798 ) 2,351 (24 )% Impairment Loss on PPE - (3,345 ) 3,345 (100 )% Other income, net 325 143 182 127 % Loss before income taxes (7,121 ) (13,000 ) 5,878 (45 )% Income tax expense/benefit - - - - Net loss attributable to common stockholders (7,121 ) (13,000 ) 5,878 (45 )% Revenue – During Fiscal 2025, the Company’s revenue decreased by $74 thousand from $1.3 million in Fiscal 2024 to $1.2 million in Fiscal 2025.
(4) Revenue from white label services consists of rebranding our formulations or the customer’s products as per the customer’s requirement. 43 Table of Contents Property, plant, and equipment Property, plant, and equipment are recorded at cost, net of accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets.
(3) Other consists of income from the rental of heavy construction equipment and the execution of contracts directly or through subcontractors. 49 Table of Contents Property, plant, and equipment Property, plant, and equipment are recorded at cost, net of accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets.
Cost of revenue – The cost of revenue amounted to approximately $612 thousand for Fiscal 2024, compared to $469 thousand in Fiscal 2023, this represents a gross margin of 54% and 49%, respectively.
In the future, our revenue from white label may not increase as we allocate more resources to expanding our core pharma focused programs. Cost of revenue – The cost of revenue amounted to approximately $652 thousand for Fiscal 2025, compared to $612 thousand utin Fiscal 2024, this represents a gross margin of 49% and 54%, respectively.
For Fiscal 2024, the Company reported SG&A expenses of approximately $6.7 million, representing a decrease of approximately $2 million, or 21%, compared to the $8.5 million recorded in Fiscal 2023. This decline in SG&A expenses is attributable to a reduction in non-cash expenses and costs related to employees and Legal & professional services.
For Fiscal 2025, the Company reported SG&A expenses of approximately $4.4 million, representing a decrease of approximately $2.3 million, or 35%, compared to the $6.7 million recorded in Fiscal 2024.
Non-cash expenses consist of an amortization and depreciation charge of approximately $0.7 million, stock-based expenses of approximately $2.8 million, and other non-cash expenses of approximately $0.2 million.
Non-cash expenses consist of an amortization and depreciation charge of approximately $618 thousand, stock-based expenses of approximately $1.6 million, impairment loss of approximately $152 thousand and an approximately $12 thousand decrease in other non-cash items.
While there is no guarantee that we will be successful, we are applying to non-dilutive funding opportunities such as Small Business Research and Development programs. In addition, subject to limitations on the amount of capital that can be raised, the Company expects to utilize its shelf registration on statement on Form S-3 to raise capital through at-the-market offerings or otherwise.
In addition, subject to limitations on the amount of capital that can be raised, the Company expects to utilize its shelf registration on statement on Form S-3 to raise capital through at-the-market offerings or otherwise. Please refer to Item 1A. “Risk Factors” for further information on the risks related to the Company.
The Company expects to raise capital for its trials as and when it is able to do so, but there can be no assurance thereof. In addition, there can be no assurance of the terms thereof, and any subsequent equity financing sought may have dilutive effects on our current shareholders.
In addition, there can be no assurance of the terms thereof, and any subsequent equity financing sought may have dilutive effects on our current shareholders. While there is no guarantee that we will be successful, we are applying to non-dilutive funding opportunities such as Small Business Research and Development programs.
The primary source of revenue in both years was from the Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others. The growth can be attributed to higher sales volume driven by increased sales and marketing efforts.
The primary source of revenue in both years was from the Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others. Fiscal 2024, the Company also generated $164 thousand in revenue from the Infrastructure business. However, in Fiscal 2025, revenue from Infrastructure was nil due to the completion of all infrastructure projects.
The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products and services in both segments. 40 Table of Contents Selling, general, and administrative ( “ SG&A ” ) expenses –SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances.
The slight decrease in gross margin is attributed to the Company’s strategic efforts to develop new formulations using a broader range of active ingredients, which, while affecting margins in the short term, are expected to open new commercial avenues in the long term. 45 Table of Contents Selling, general, and administrative (SG&A) expenses –SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances.
Net cash used in investing activities for Fiscal 2023, was approximately $0.2 million, which comprises approximately $0.3 million for the acquisition and filing expenses related to intellectual property, approximately $0.2 million for the purchase of property, plant, and equipment and approximately $0.1 million of a short-term investment.
Investing Activities Net cash used in investing activities for Fiscal 2025, was approximately $442 thousand, which comprises approximately $370 thousand for the acquisition and development of intangible assets, and approximately $72 thousand from the net purchase of property, plant, and equipment.
In the Life Sciences segment, the revenue from the wellness and lifestyle business is recognized once goods have been sold to the customer and the performance obligation has been completed. In retail sales, we offer consumer products through our online stores. Revenue is recognized when control of the goods is transferred to the customer.
In retail sales, we offer consumer products through our online stores. Revenue is recognized when control of the goods is transferred to the customer. This generally occurs upon our delivery to a third-party carrier or to the customer directly.
Net sales disaggregated by significant products and services for Fiscal 2024 and 2023 are as follows: (in thousands) Year Ended March 31 2024 ($) 2023 ($) Infrastructure segment Rental income (1) 18 37 Construction contracts (2) 146 76 Life Sciences segment Wellness and lifestyle (3) 228 416 White label services (4) 953 382 Total 1,345 911 (1) Rental income consists of income from the rental of heavy construction equipment.
Net sales disaggregated by significant products and services for Fiscal 2025 and 2024 are as follows: (in thousands) Year ended March 31, 2025 ($) 2024 ($) Wellness and lifestyle (1) 113 228 White labeling services (2) 1,158 953 Other (3) - 164 Total 1,271 1,345 (1) Revenue from wellness and lifestyle consists of the sale of products such as gummies, hand sanitizers, bath bombs, lotions, beverages, hemp crude extract, hemp isolate, and hemp distillate.
The equity and the credit facility serve to minimize ongoing liquidity requirements and ensure the Company’s ability to sustain its operations. Furthermore, the Company intends to raise additional funds through private placement and ATM offerings, subject to market conditions. Please refer, Note 13 – “Securities”, for more information.
The equity and the credit facility serve to minimize ongoing liquidity requirements and ensure the Company’s ability to sustain its operations.
The Global Economic Environment In addition to the industry-specific factors, such as regulations around cannabinoid research, we are exposed to economic cycles.
It is designed to treat agitation in Alzheimer’s dementia, a common and difficult-to-manage neuropsychiatric symptom that significantly impacts millions of patients’ well-being and caregiver burden. 42 Table of Contents The Global Economic Environment In addition to the industry-specific factors, such as regulations around cannabinoid research, we are exposed to economic cycles.
Complying with these security measures and compliances is expected to incur further expenses. In Fiscal 2024 and Fiscal 2023, there were no known or detected breaches in cybersecurity. Recently issued and adopted accounting pronouncements Changes to U.S.
Complying with these security measures and compliances is expected to incur further expenses. In Fiscal 2025 and Fiscal 2024, there were no known or detected material breaches in cybersecurity. Off-balance sheet arrangements We do not have any outstanding derivative financial instruments, off-balance sheet guarantees, interest rate swap transactions or foreign currency forward contracts.
During Fiscal 2024, the Company successfully obtained a working capital credit facility totaling $12 million and, in addition, signed two SPAs to raise $6 million in exchange for approximately 18.8 million shares. Out of $6 million, the Company received $2.5 million after the end of Fiscal 2024, in April 2024.
Pursuant to the Master Loan and Security Agreement (the Credit Agreement) with O-Bank, Co., Ltd., the Company successfully obtained a working capital credit facility totaling $12 million and, in addition, raised approximately $4.64 million in exchange for approximately 14.2 million shares.
Research and Development ( “ R&D ” ) expenses – R&D expenses were primarily associated with the Life Sciences segment, reflecting the Company’s investment in R&D activities. In Fiscal 2024, the Company reported R&D expenses of approximately $3.8 million, representing an increase of $312 thousand or 9% compared to approximately $3.5 million in Fiscal 2023.
These optimizations allowed the Company to preserve capital and extend its operational runway while maintaining the infrastructure necessary to support clinical development and strategic initiatives. Research and Development (R&D) expenses – R&D expenses were primarily associated with the Life Sciences segment, reflecting the Company’s investment in R&D activities.
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Overview IGC Pharma, a clinical-stage pharmaceutical company, is at the forefront of the fight against Alzheimer’s disease, focusing on innovations to combat this pervasive neurodegenerative condition. Our flagship investigational new drug, IGC-AD1, represents an advancement in addressing the challenges posed by Alzheimer’s, particularly in managing agitation associated with the disease.
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Overview IGC Pharma, a clinical-stage pharmaceutical company developing treatments for Alzheimer’s disease (AD) and related neurodegenerative conditions, is committed to transforming patient care by seeking to offer faster-acting and more effective solutions.
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In our Phase 2 clinical trial, IGC-AD1 has demonstrated efficacy in reducing agitation in patients with Alzheimer’s disease. The interim results reveal an Effect Size (“ES”) of 0.79 (p=0.04), indicating a clinical and statistically significant reduction in agitation compared to the use of a placebo.
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The Company’s research and development efforts are centered on addressing some of the most challenging and underserved symptoms of Alzheimer’s, with the lead investigational candidate, IGC-AD1, positioned at the forefront of this strategy.
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This data underscores the potential of IGC-AD1 to provide tangible benefits for patients and caregivers grappling with the debilitating symptoms of Alzheimer’s. One of the key distinguishing features of IGC-AD1 is its rapid onset of action.
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Clinical Trial Operational Excellence As part of our commitment to operational discipline and patient-centric innovation, we continue to focus not only on the scientific rigor of our clinical trials but also on their cost-effectiveness. For our Phase 2 trial of IGC-AD1, we have successfully optimized trial operations to bring the cost per patient enrolled to approximately $70 thousand.
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Unlike traditional anti-psychotics, which may take between 6 to 12 weeks to exert their effects, our investigational drug has shown the potential to act within two weeks. This accelerated timeline not only offers hope for expedited relief to patients but could also signify a paradigm shift in the treatment approach for Alzheimer’s-related agitation.
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This represents a significant improvement over industry norms for Alzheimer’s trials, where average per-patient costs can exceed $100 thousand to $150 thousand, according to multiple industry benchmarks for mid-stage neurodegenerative clinical trials.
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IGC Pharma is pursuing a robust pipeline comprising five assets, each targeting different facets of Alzheimer’s disease at various stages of development. ● IGC-AD1 : Our blockbuster drug, currently undergoing a Phase 2 clinical trial (clinicaltrials.gov, CT05543681), IGC-AD1 holds significant promise in alleviating the burden of agitation in this vulnerable population.
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These efficiencies reflect our strategic use of: ● In-house site selection, training of clinical sites, monitoring, audit, scientific, and clinical trial operations ● In house regulatory and marketing to potential patients for each of the clinical trial sites ● Technology-enabled patient recruitment and monitoring By keeping trial costs below market averages while maintaining robust clinical standards, we believe we are well-positioned to deliver high-quality data and extend our cash runway, both critical to de-risking our development timeline and enhancing shareholder value, although there can be no assurance thereof.
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This CB1 partial agonist is specifically designed to address neuroinflammation associated with agitation in Alzheimer’s patients. ● TGR-63 : Through pre-clinical studies, TGR-63 has demonstrated its potential to disrupt the progression of Alzheimer’s by targeting Aβ plaques, a hallmark feature of the disease.
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Clinical Trial Updates ● On March 26, 2025, the Company announced additional positive interim results from its ongoing Phase 2 clinical trial on IGC-AD1, an investigational treatment for agitation in dementia due to AD. The results suggest that IGC-AD1 may decrease the frequency and/or severity of sleep disturbances and nighttime behaviors.
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This approach offers new avenues for intervening in the underlying pathology of Alzheimer’s. ● IGC-1C : At the preclinical stage, we believe IGC-1C represents a forward-thinking approach to Alzheimer’s therapy by targeting tau protein and neurofibrillary tangles, crucial contributors to the neurodegenerative process.
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Based on the interim analysis at week 2, sleep disturbance was reduced by about 71% (p=.012) and at week 6, about 78% (p=.02) for those on the active medication.
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By addressing these pathological mechanisms, IGC-1C holds promise for disease-modifying interventions. ● IGC-M3 : Also in preclinical development, IGC-M3 aims to inhibit the aggregation of Aβ plaques, offering potential therapeutic benefits in early-stage Alzheimer’s by targeting the underlying pathology responsible for cognitive decline. ● LMP : Designed to target multiple hallmarks of Alzheimer’s disease, including Aβ plaques and neurofibrillary tangles, LMP represents a comprehensive therapeutic approach to addressing the complex pathophysiology of the disease. 38 Table of Contents In addition to our pipeline of therapeutic candidates, IGC Pharma is attempting to leverage Artificial Intelligence (“AI”) to develop models for the early detection of Alzheimer’s and to optimize clinical trial design.
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These values indicate a clinical and statistically significant reduction in sleep disturbances among Alzheimer’s patients receiving the active medication compared to placebo, as measured by the Neuropsychiatric Inventory (NPI-12) Sleep Subscale. ● During fiscal 2025, the Company expanded the CALMA Phase 2 trial by adding 13 prestigious research sites, including Miami Jewish Health and Butler Hospital’s Memory and Aging Program, to accelerate patient enrollment and diversify the study population. 43 Table of Contents ● Based on the interim results, the secondary endpoint showed a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.
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By integrating cutting-edge technology with innovative drug development, we are striving to make significant steps in the fight against Alzheimer’s disease. Furthermore, IGC controls a total of 28 patent filings reflecting our commitment to innovation and intellectual property protection, including for IGC-AD1. Our patent portfolio underscores our dedication to safeguarding our competitive advantage in the market.
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CMAI LS mean difference at week 2, assessing early response, was -12.19 with an ES of 0.79 (p= .071) .
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IGC Pharma Inc., is a Maryland corporation established in 2005 with a fiscal year ending on March 31, spanning a 52- or 53-week period. IGC has two segments: Life Sciences Segment and Infrastructure Segment. Please refer to Note 1, “Nature of Operations,” and Item 8 of this Annual Report on Form 10-K, for further information on business segments .
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Table 2:- Interim CMAI Results for Week 2 and Week 6 Week 2 Week 6 (EOT) Scale LS Mean Change (95% CI) p value Cohen’s d LS Mean Change (95% CI) p value Cohen’s d CMAI -12.19 (-25.52, 1.14) .071 0.79 -10.46 (-20.53, -0.4) .042 0.79 Interim data from our Phase 2 trial of IGC-AD1 for agitation in Alzheimer’s disease show a statistically significant improvement in symptoms compared to placebo over six weeks, as measured by the Cohen-Mansfield Agitation Inventory (CMAI).
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Operational Excellence We remain focused on continuing to build excellence broadly in three areas, cannabinoid-based investigations, drug development and product manufacturing, and online marketing. Although there can be no assurance, we believe these will give us a competitive advantage, including building an increasingly agile and adaptable commercialization engine with a strong customer-focused market expertise.
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IGC-AD1 demonstrated a large effect size (Cohen’s d = 0.79) and showed improvement as early as Week 2. For context, Brexpiprazole (Rexulti), the currently approved therapy showed separation from placebo only by Week 6, based on published trial data. In addition to efficacy, IGC-AD1 has shown a favorable safety profile to date.
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Fiscal 2024 Highlights ● During Fiscal year ended March 31, 2024, the Company entered into Share Purchase Agreements (the “SPAs”) with multiple investors, resulting in approximately $6 million in gross proceeds. In addition, the Company also received a $12 million credit line from O Bank.
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As of the 6-week interim analysis: ● No serious adverse events (SAEs) were reported ● No adverse events (AEs) led to treatment discontinuation ● No deaths occurred in the treatment or placebo arms While cross-trial comparisons must be interpreted with caution due to differences in trial design and patient populations, these findings suggest that IGC-AD1 may offer faster symptom relief with a potentially improved safety profile compared to the currently approved therapy.
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This is a significant achievement and underscores our commitment to expanding operations and generating value for stakeholders. ● The Company has announced, on March 20, 2024, positive interim results from its ongoing Phase 2 trial investigation IGC-AD1. The trial has shown promising results in reducing Alzheimer’s agitation, which is a major challenge for patients and their caregivers alike.
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The Phase 2 trial remains ongoing to complete 146 patients. 44 Table of Contents Business Updates ● On January 21, 2025, the Company appointed Terry McAuliffe, the 72 nd Governor of Virginia, as a strategic advisor.
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This development marks a significant step forward in the fight against Alzheimer’s and brings hope to millions of people affected by this devastating disease. ● On January 17, 2024, the Company announced that Clincloud, a clinical research facility in Florida, has dosed its first patient as part of the Company’s ongoing Phase 2 trial. ● On January 23, 2024, the Company announced details about its drug candidate TGR-63, which specifically targets amyloid-beta plaque, which has the potential to significantly improve the treatment of Alzheimer’s disease.
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Governor McAuliffe’s extensive leadership experience across public and private sectors will play a pivotal role in advancing IGC Pharma’s mission to redefine Alzheimer’s care and position for growth in the biotechnology and pharmaceutical industries. ● Through Fiscal 2025 the Company raised over $4.64 million through different private equity placement SPAs and the ATM.
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Subsequently, on February 1, 2024, the Company announced further positive results from preclinical studies of TGR-63, demonstrating its potential as an effective treatment for Alzheimer’s disease.
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Please refer to Note 13 – “Securities” for more information.
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These studies demonstrated that TGR-63 was successful in reducing plaque burden in Alzheimer’s cell lines and animal models, making it a promising therapeutic candidate for the disease. 39 Table of Contents ● The company had significant following achievements in our intellectual property rights: ● On October 25, 2023, Divisional Direction of Patents, Mexico, issued a Granting Office Action (the “GOA”) to the Company titled “METHOD AND COMPOSITION FOR TREATING CNS DISORDER”, for the treatment of Alzheimer’s disease.
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Excluding Infrastructure, revenue from the Life Sciences segment increased from $1181 thousand in Fiscal 2024 to $1271 thousand in Fiscal 2025. Our core focus is on advancing IGC-AD1, the completion of the Phase 2 trial, and development of MINT-AD for early diagnosis of Alzheimer’s.
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Subsequently, Divisional Direction of Patents in Mexico granted a patent on January 3, 2024. ● On October 18, 2023, the European Patent Office (“EPO”) issued a patent (#3193862) to the Company titled “CANNABINOID COMPOSITION AND METHOD FOR TREATING PAIN”. The patent introduces a method for treating pain in humans.
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The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products and services in both segments.
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Utilizing a cream base infused with a unique blend of cannabinoids, including THC and CBD, alongside other compounds, this revolutionary cream or gel is designed for transdermal absorption.
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This significant decline in SG&A expenses is attributable to the Company’s focused efforts to optimize corporate-level operational efficiency by lowering employee–related costs due to headcount alignment and compensation restructuring, implementing better inventory management systems, and reducing spending on legal and professional services through more efficient vendor management.
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It interacts harmoniously with the peripheral nervous and immune systems, delivering effective pain relief without psychotropic or adverse side effects. ● On July 11, 2023, the Canadian Intellectual Property Office issued a patent (#2,961,410) to the Company titled “CANNABINOID COMPOSITION AND METHOD FOR TREATING PAIN”.
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In a demonstration of cost and cash discipline, management elected to convert approximately $750 thousand in accrued bonuses into performance-based compensation, payable only upon the achievement of defined business milestones, which also align with shareholder interest.
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The patent relates to compositions and methods for treating multiple types of seizure disorders in humans using a combination of cannabinoids with other compounds.
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As the development of TGR-63 and the Phase 2 trial on Alzheimer’s gains momentum, the Company anticipates increase in R&D expenses. Impairment loss on Property, Plant, and Equipment (PPE) – During Fiscal 2025, there was no impairment loss on PPE.
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Subject to further research and study, the combination may be used for relieving pain in patients with psoriatic arthritis, fibromyalgia, scleroderma, shingles, and related pain-generating conditions. ● On July 21, 2023, IGC Pharma and the University of Los Andes (Faculty of Engineering) signed a Master Cooperation Agreement to conduct innovative research in AI applied to the pharmaceutical industry and to join efforts to create academic spaces that allow for generating research and development projects and innovation.
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Furthermore, the Company intends to raise additional funds through private placement and ATM offerings, subject to market conditions, although there can be no assurance that such financing efforts will be successful or as to any private placement or the terms of such offering. Any equity issuances would be dilutive to shareholders.
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The increase in revenue derived from the Company’s commitment to its current strategy of driving sales in formulations both as branded and white-labeled products in the Life Science segment. Approximately 10%-12% of revenue in both years was derived from the Infrastructure segment.
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Please refer to Note 13 – “Securities”, for more information. On July 29, 2024, the Company entered into an amendment to extend the Credit Agreement, effective July 8, 2024.

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Other IGC 10-K year-over-year comparisons