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What changed in IGC Pharma, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of IGC Pharma, Inc.'s 2023 and 2024 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 2024 report.

+314 added−361 removedSource: 10-K (2024-06-24) vs 10-K (2023-07-07)

Top changes in IGC Pharma, Inc.'s 2024 10-K

314 paragraphs added · 361 removed · 193 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

86 edited+63 added−78 removed68 unchanged
Biggest changePlease see Item 1A, Risk Factors- “We may not successfully register the provisional patents with the USPTO.” The Table below provides the status of our patent filings: TARGET DESCRIPTION PATENT PENDING GRANTED PATENTS US FOREIGN Alzheimer’s Disease (IGC-AD1)​ Method & Composition for Treating CNS Disorders​ 10 2 - Alzheimer’s Disease (TGR-63) ​ Manufactured molecule with ability to impact plaque build-up 10 1 1 Alzheimer’s Disease (IGC-LMP)​ Composition, Synthesis, & Medical use of Hybrid Cannabinoid​ 1 - - Epilepsy​ Composition & Method for Treating Seizures in Mammals 2 2 - Eating Disorders ​ Method & Composition for Treating Cachexia & Eating Disorders​​ 1 1 - Stuttering & Tourette Syndrome ​ Compositions & Methods using Cannabinoids for Treating Stuttering & Symptoms of Tourette Syndrome ​ 5 - - Fatigue & Restoring Energy​​ Cannabis-Based Method & Compositions for Relieving Fatigue & Restoring Energy​ 6 - - Pain​ Cannabinoid Composition & Method for Treating Pain​ 6 2 - TOTAL 41 8 1 13 Table of Contents Products & Services We market our brand, Holief™, and the formulations for the products, in accordance with applicable laws and regulations.
Biggest changePlease 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.
The misfolded structure of Aβ proteins, along with NFTs, generates a characteristic tendency for their aggregation (Chiti & Dobson, 2006) around damaged or dead neurons and within cerebral vasculature in the brain. It manifests by memory loss followed by progressive dementia.
The misfolded structure of Aβ proteins, along with NFTs, generates a characteristic tendency for their aggregation (Chiti & Dobson, 2006) around damaged or dead neurons and within cerebral vasculature in the brain. It manifests in memory loss followed by progressive dementia.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.
One major cost driver in conducting trials is the expense associated with engaging CROs. These costs can significantly impact on the overall budget of a trial. To address this challenge and optimize trial costs, we have established an internal CRO, including proprietary software that we believe sets us apart from the traditional approach of outsourcing.
One major cost driver in conducting trials is the expense associated with engaging CROs. These costs can significantly impact the overall budget of a trial. To address this challenge and optimize trial costs, we have established an internal CRO, including proprietary software, that we believe sets us apart from the traditional approach of outsourcing.
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.
Achieving favorable coverage and reimbursement from the Centers for Medicare and Medicaid Services (CMS) and/or the Medicare Administrative Contractors is typically a significant gating issue for successful introduction of a new product. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy.
Achieving favorable coverage and reimbursement from the Centers for Medicare and Medicaid Services (“CMS”) and/or the Medicare Administrative Contractors is typically a significant gating issue for the successful introduction of a new product. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy.
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov. The contents of these websites are not incorporated into this filing. Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only. 21 Table of Contents
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov. The contents of these websites are not incorporated into this filing. Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only.
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.
We measured and analyzed the change in the mean NPI score for Agitation between Day 1 and Day 10 and between Day 1 and Day 15 for all three cohorts. ● As shown in Table below, our analysis shows Cohort 2 had the largest absolute change in the mean Agitation score between Day one and Day ten (53% drop, p=.085) as well as between Day 1 and Day 15 (67% drop, p=.05).
We measured and analyzed the change in the mean NPI score for agitation between Day 1 and Day 10 and between Day 1 and Day 15 for all three cohorts. ● As shown in the Table 1, our analysis shows Cohort 2 (bid) had the largest absolute change in the mean agitation score between Day one and Day ten (53% drop, p=.085) as well as between Day 1 and Day 15 (67% drop, p=.05).
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, copyrights applications, and trademark applications; trade secret laws of general applicability; employee confidentiality and invention assignment.
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.
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”).
Competitors may use this publicly available information to gain knowledge regarding the design and progress of our development programs. 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. 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.
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.
We believe this strategic move will 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.
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”).
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.
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.
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”).
B) Reduction of cortical and hippocampal amyloid burden by TGR63 treatment: Higher magnification images of vehicle and TGR63 treated mice (WT and AD) brain sections to visualize and compare the Aβ plaques deposition in the cortex and hippocampus areas.
B) Reduction of cortical and hippocampal amyloid burden by TGR-63 treatment: Higher magnification images of vehicle and TGR-63 treated mice (WT and AD) brain sections to visualize and compare the Aβ plaques deposition in the cortex and hippocampus areas.
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. A double-blind, single-site, randomized, three cohort, multiple-ascending dose (MAD) clinical trial (FDA IND Number: 146069, NCT04749563) was conducted 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.
If the applicant does not challenge the listed patents, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired. 19 Table of Contents A certification that the new product will not infringe the already approved product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.
If the applicant does not challenge the listed patents, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired. A certification that the new product will not infringe the already approved product’s listed patents or that such patents are invalid is called a Paragraph IV certification.
The Company is subject to the informational requirements of the Exchange Act and files or furnishes reports, proxy statements, and other information with the SEC. Such reports and other information filed by the Company with the SEC are available free of charge on the Company’s website at www.igcinc.us when such reports are available on the SEC’s website.
The Company is subject to the informational requirements of the Exchange Act and files or furnishes reports, proxy statements, and other information with the SEC. Such reports and other information filed by the Company with the SEC are available free of charge on the Company’s website at www.igcpharma.com when such reports are available on the SEC’s website.
Secondary Endpoints: Neuropsychiatric Inventory (NPI) Neuropsychiatric Symptoms (NPS) such as delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy, disinhibition, irritability, 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 Alzheimer’s disease (Phan et al., 2019).
During Fiscal 2023, we distributed $194 thousand worth of hand sanitizers and other wellness products in an effort to expand the Company’s ESG programs. Employees. As of March 31, 2023, we employed a team of approximately 61 full-time employees in our two segments. We also have contract workers and advisors in the U.S., India, Colombia, and Hong Kong.
During Fiscal 2024, we distributed $154 thousand worth of hand sanitizers and other wellness products in an effort to expand the Company’s ESG programs. Employees. As of March 31, 2024, we employed a team of approximately 67 full-time employees in our two segments. We also have contract workers and advisors in the U.S., India, Colombia, and Hong Kong.
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).
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.
Hemp and Marijuana are both cannabis plants. 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. Marijuana is classified as a cannabis plant that has THC above 0.3% by dry weight.
Table 1: NPI analysis for each of the three cohorts Domain Cohort 1 (n=7) Cohort 2 (n=6) Cohort 3 (n=5) Agitation Baseline Day Day Baseline Day Day Baseline Day Day Day 0 10 15 Day 0 10 15 Day 0 10 15 Mean Score 4.7 3.3 3 4.3 2.1 1.5 4.2 3.2 1.4 Mean Change - 1.4 1.7 - 2.2 2.8 - 1 2.8 Mean Change% - 37% 48% - 53% 67% - 23% 67% p-values - 0.058 0.045 - 0.085 0.05 - 0.29 0.045 P(T According to the NPI Test, a reduction of 4 points or 30% in the score is considered clinically meaningful.
Table 1: NPI (Agitation) analysis for each of the three cohorts Domain Cohort 1 (n=7) qd Cohort 2 (n=6) bid Cohort 3 (n=5) tid NPI (Agitation) Baseline Day Day Baseline Day Day Baseline Day Day Day 0 10 15 Day 0 10 15 Day 0 10 15 Mean Score 4.7 3.3 3 4.3 2.1 1.5 4.2 3.2 1.4 Mean Change - 1.4 1.7 - 2.2 2.8 - 1 2.8 Mean Change% - 37% 48% - 53% 67% - 23% 67% p-values - 0.058 0.045 - 0.085 0.05 - 0.29 0.045 According to the NPI, a reduction of 4 points or 30% in the score is considered clinically meaningful (Cummings et al., 1994).
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) (Cummings et al., 1994) 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.
The NPI is used by about 50% of neurologists to assess and treat Alzheimer’s patients (Fernandez et al., 2010). 9 Table of Contents In the Phase 1 trial conducted on patients with Alzheimer’s disease, we measured changes in NPS as assessed by the NPI-12 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 Alzheimer’s disease, we measured changes in NPS as assessed by the NPI as well as caregiver distress as assessed by the NPI-D.
It is known for being a psychoactive substance that can impact mental processes in a positive or negative way, depending on the dosage. THC is biphasic, meaning that low and high doses of the substance may affect mental and physiological processes in substantially different ways.
THC is a naturally occurring cannabinoid produced by the cannabis plant. It is known for being a psychoactive substance that can impact mental processes in a positive or negative way, depending on the dosage. THC is biphasic, meaning that low and high doses of the substance may affect mental and physiological processes in substantially different ways.
To create and sustain a safe and healthy workplace, we have implemented initiatives designed to address risk evaluation, education and training of employees, use of appropriate personal protective equipment, and compliance with relevant health and safety standards. Environmental, Social, and Governance (ESG) Efforts .
Workplace safety is always a top priority for the Company. To create and sustain a safe and healthy workplace, we have implemented initiatives designed to address risk evaluation, education and training of employees, use of appropriate personal protective equipment, and compliance with relevant health and safety standards. Environmental, Social, and Governance (ESG) Efforts .
In some cases, the FDA may require post-market studies, known as Phase 4 studies, to be conducted as a condition of approval in order to gather additional information on the drug’s effect in various populations and any side effects associated with long-term use. Depending on the risks posed by the drugs, other post-market requirements may be imposed.
In some cases, the FDA may require post-market studies, known as Phase 4 studies, to be conducted as a condition of approval in order to gather additional information on the drug’s effect in various populations and any side effects associated with long-term use.
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.
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.
In Alzheimer’s patients, neurotoxicity is linked to beta amyloid (Aβ) plaques and Neuro Fibrillary Tangles (NFT). JNCASR’s research based on Alzheimer’s cell lines identified one lead NMI molecule, TGR-63, from a family of NMI molecules, with the potential to reduce beta amyloid (Aβ) plaques. Further, they demonstrated that the molecule reduces cognitive decline in a transgenic mouse model of Alzheimer’s.
JNCASR’s research based on Alzheimer’s cell lines identified one lead NMI molecule, TGR-63, from a family of NMI molecules with the potential to reduce amyloid beta (Aβ) plaques. Further, they demonstrated that the molecule reduces cognitive decline in a transgenic mouse model of Alzheimer’s.
Life Sciences Products and General Management General business License to grow hemp; Industrial Alcohol User Permit; Clinical Trials; Good Manufacturing Practices (GMP) certification. General business licenses; License to grow hemp; Industrial Alcohol User Permit; Clinical Trials GMP Certificate. None.
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.
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). These behavioral disturbances not only affect the patient’s quality of life but also cause extreme emotional distress for the caregivers.
These include agitation, anxiety, disturbance of the sleep cycle, depression, inappropriate sexual behavior, disinhibition, and irritability, among others (Lyketsos, et al., 2011). These behavioral disturbances not only affect the patient’s quality of life but also cause extreme emotional distress for the caregivers.
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.
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.
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.” Data that is relevant to the Phase 1 protocol and the design of the Phase 2 trial are presented here.
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.
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.
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 .
The EDC system is designed to store and organize handwritten source documents, including medical history, concomitant medications, laboratory results, neuropsychiatric scales scores, adverse events, vital signs, safety calls, demographics, among others.
This format is designed for our clinical trials, especially our Phase 2 trial. The EDC system is designed to store and organize handwritten source documents, including medical history, concomitant medications, laboratory results, neuropsychiatric scale scores, adverse events, vital signs, safety calls, and demographics, among others.
Their results were published in Advanced Therapeutics under the title “Naphthalene Monoimide Derivative Ameliorates Amyloid Burden and Cognitive Decline in a Transgenic Mouse Model of Alzheimer’s Disease” on January 28, 2021.
Their results were published in Advanced Therapeutics under the title “Naphthalene Monoimide Derivative Ameliorates Amyloid Burden and Cognitive Decline in a Transgenic Mouse Model of Alzheimer’s Disease” on January 28, 2021. Pursuant to the signed agreement dated March 28, 2022, IGC Pharma (through Hamsa Biopharma India Pvt.
These investments will fuel the development and delivery of innovative products that drive positive patient and customer experiences. We hope to leverage our R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through clinical trials, subject to FDA approval.
We hope to leverage our R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through clinical trials, subject to FDA approval.
General business license; Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Permits; Fondo Nacional De Estupefacientes (FNE) Permits. 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.
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.
Symptoms of AD depend on the stage of the disease: preclinical, mild, moderate, or severe. 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, are also seen with disease progression (Tang et al., 2019).
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.
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.
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.
Disclosure of Clinical Trial Information Sponsors of clinical trials of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information on a public website maintained by the U.S. National Institutes of Health.
It offers some advantages like more frequent meetings with the FDA and potential for rolling review (reviewing data as it becomes available). Disclosure of Clinical Trial Information Sponsors of clinical trials of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information on a public website maintained by the U.S. National Institutes of Health.
We have also begun working on overlaying machine learning technologies and Artificial Intelligence (AI) into the 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, although there can be no assurance thereof.
We have also begun working on overlaying machine learning technologies and Artificial Intelligence (“AI”) into the 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, although there can be no assurance. 13 Table of Contents Intellectual Property Our goal is to use our intellectual property (“IP”) to develop products that we can bring to market in one or more of the following channels: 1.
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. Our Infrastructure strategy includes the following: ● Executing existing construction contracts, and ● leasing heavy construction equipment.
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.
In this document, we refer to the trial as Phase 2 and Phase 2B interchangeably. The Company has initiated a Phase 2B protocol titled “A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled, trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease”.
IGC-AD1 Phase 2 Clinical Trial Update IGC Pharma launched a Phase 2 trial with a protocol titled “A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled, trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease” (clinicaltrials.gov, Identifier: CT05543681).
The Company holds all rights to the patents that have been filed by us with the USPTO. 16 Table of Contents The table below summarizes the nature of the activity, type of license required and held, and encumbrances in obtaining permits for each location where the Company operated through its subsidiaries in Fiscal 2023: 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 2024: Location Nature of Activity Type of License Required Type of License held Encumbrances in Obtaining Permit U.S.
Figure 7: Shows the reduction of the amyloid burden by TGR63 in the APP/PS1 AD phenotypic mice model: Figure 7 shows the Reduction of amyloid burden by TGR63 in 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. 11 Table of Contents Figure 5: Reduction of the amyloid burden by TGR-63 in the APP/PS1 AD phenotypic mice model.
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. Long-term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.
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.
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. 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.
Our wellness and lifestyle products compete with multiple well-established companies, in the food, beverage, and skincare industries. We also face competition from companies with experience in wholesaling hemp crude extract and hemp isolate as well as companies that provide white labeling and tolling services.
Our wellness products and services compete with multiple well-established companies in the food and skincare industries. We also face competition from companies with experience in providing white labeling and tolling services. 15 Table of Contents 2.
In the Phase 1 trial (N=10), seven received the active medication, and at baseline they had symptomatic Agitation with domain scores between two and twelve. In Cohorts two and three six Participants had symptomatic Agitation.
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”).
The FDA’s current performance goals call for the FDA to complete 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). 18 Table of Contents The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee, which is typically a panel that includes clinicians and other experts, for review, evaluation, and a recommendation as to whether the application should be approved.
The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee, which is typically a panel that includes clinicians and other experts, for review, evaluation, and a recommendation as to whether the application should be approved.
It is unclear how future FDA guidance and ruling on hemp-based food, beverage, and cosmetic products will impact the market. 2. Infrastructure segment: The infrastructure industry in India and Hong Kong is highly competitive. Our differentiation is based primarily on price and local and industry knowledge of construction requirements in the regions where we operate.
Infrastructure segment: The infrastructure industry in India is highly competitive, and our differentiation is based primarily on price and local and industry knowledge of construction requirements in the regions where we operate.
Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA application user fee. 20 Table of Contents 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.
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, such as a resurgence of COVID and the enforcement of lockdowns and travel restrictions. Agitation is a behavioral syndrome characterized by increased, often undirected, motor activity, restlessness, aggressiveness, and emotional distress.
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, such as a resurgence of COVID and the enforcement of lockdowns and travel restrictions. Symptoms of AD depend on the stage of the disease: preclinical, mild, moderate, or severe.
Both forms of AD are characterized by extracellular amyloid-β (Aβ) plaques and intracellular tau-containing neurofibrillary tangles (Gӧtz, et al., 2011). 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.
FDA Approval Process In the U.S., pharmaceutical products are subject to extensive regulation by the FDA.
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.
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. As the disease progresses to moderate, there is damage to the areas of the brain that control language, reasoning, sensory processing, and conscious thought.
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.
A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has not imposed a clinical hold on the IND or otherwise commented or questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.
If the FDA has not imposed a clinical hold on the IND or otherwise commented on or questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin. Clinical trials involve the administration of an investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator.
The trial concluded that all three dosing levels were safe with no serious or life-threatening events or deaths reported.
In this trial, we looked at safety, tolerability, neuropsychiatric symptoms, and pharmacokinetics, among others. The trial concluded that all three dosing levels (once a day, twice a day, and twice a day) were safe, with no serious or life-threatening events or deaths reported.
We believe that building an online community that brings women together can create brand equity, loyalty, generate revenue, and drive valuation. 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.
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.
The software incorporates rigorous security measures that help IGC to protect data and ensure compliance with regulatory requirements and industry standards. This format is designed for our clinical trials, especially our Phase 2 trial.
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.
In Fiscal 2023, our sales and suppliers were concentrated, which represents some risk. Two customers accounted for over 10% of sales. Infrastructure segment In Fiscal 2023, our infrastructure business focused on projects in the state of Kerala. While executing this construction project, we took advantage of other opportunities to generate revenue from our infrastructure assets.
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.
IGC-AD1 Clinical Trial Data To the best of our knowledge, the Company’s Phase 1 clinical trial testing the safety and tolerability 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. THC is a naturally occurring cannabinoid produced by the cannabis plant.
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.
Al., 2006). 11 Table of Contents NMI Compounds Researchers at the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), in India conducted approximately 10 years of research and discovery work on naphthalene monoimide (NMI) compounds and the role of NMI compounds on neurotoxicity associated with Alzheimer’s.
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”).
Infrastructure segment The Company’s infrastructure business has been operating since 2008, it includes: (i) Execution of Construction Contracts and (ii) Rental of Heavy Construction Equipment.
Although there can be no assurance, we believe the brand and the formulations have significant potential in the growing natural products-based wellness and lifestyle market. Products and Services in the Infrastructure segment The Company’s infrastructure business has been operating since 2008, it includes: (i) Execution of Construction Contracts and (ii) Rental of Heavy Construction Equipment.
The conduct of the pre-clinical tests must comply with federal regulations and requirements, including the FDA’s good laboratory practices regulations and the U.S. Department of Agriculture’s (USDA’s) regulations implementing the Animal Welfare Act.
Pre-clinical tests include laboratory evaluation of product chemistry, formulation, and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the pre-clinical tests must comply with federal regulations and requirements, including the FDA’s good laboratory practices regulations and the U.S.
In certain cases, the FDA may determine that a drug is effective based on one clinical study plus confirmatory evidence.
In certain cases, the FDA may determine that a drug is effective based on one clinical study plus confirmatory evidence. Satisfaction of FDA premarket approval requirements typically takes many years, and the actual time required may vary substantially based upon the type, complexity of the product, or disease.
The data presented here is not exhaustive. 8 Table of Contents Primary Endpoint: Safety & Tolerability (S&T) S&T was assessed by recording both solicited and non-solicited Adverse Events (AEs). The solicited AEs, assessed daily, were somnolence, falls, dizziness, asthenia, suicidal ideation, hypertension, psychiatric symptoms, and paradoxical nausea.
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”).
If we were to obtain a first-to-market advantage, such an advantage could result in significant growth if and when an approved drug launches. Our Holief™ formulation strategy includes expanding the line of products and formulations, and developing online services that connect women with healthcare professionals who can help with PMS and dysmenorrhea.
Our formulation strategy includes expanding the line of products and formulations and developing online services that connect women with healthcare professionals who can help with PMS and dysmenorrhea. We believe that building an online community that brings women together can create brand equity, loyalty, generate revenue, and drive valuation.
A) Visualization of amyloid plaques in half hemisphere: Confocal microscopy images of coronal section of WT, AD mice, and TGR63 treated AD mice brain immunostained with amyloid fibrils specific OC primary antibody followed by fluorescently (λ ex = 633nm, λ em = 650nm) labeled secondary antibody (red) and DAPI (blue).
A) Visualization of amyloid plaques in the half hemisphere: Confocal microscopy images of coronal section of WT, AD mice, and TGR-63 treated AD mice brain.
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; ● patents IGC-501, IGC-502, IGC-504, IGC-505, IGC-507, and IGC-514 for treatment of pain, treatment of seizures in humans and veterinary animals, treatment of cachexia and eating disorders in humans and veterinary animals, method and composition for treating seizure disorders, Alzheimer’s Disease and Self Assembly of Naphthalene Diimide Derivatives and Process Thereof, respectively; ● facilities and a team with experience in manufacturing, marketing, and selling products.
Our 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.
Alzheimer ’ s disease The National Institute on Aging (NIA) at the National Institutes of Health (NIH) defines Alzheimer’s as an irreversible, progressive brain disorder that destroys memory and thinking skills. According to the Alzheimer’s Association, approximately 11% of Americans over 65 have Alzheimer’s dementia, and many more could be undiagnosed.
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.
They cannot communicate, and near the end of their life, they may be largely bedridden as the body shuts down (NIA, 2021). Currently, there are limited options to help Alzheimer’s patients with the debilitating symptoms of the disease or relief for the burden placed on their caregivers (Cheng, 2017).
When severe Alzheimer’s sets in, plaques and tangles spread throughout the patient’s brain, and the brain shrinks significantly. People with severe Alzheimer’s are completely dependent on others for care. They cannot communicate, and near the end of their life, they may be largely bedridden as the body shuts down (NIA, 2021).
Figure 1: Hallmarks of Alzheimer ’ s ● Extracellular Plaque: β-amyloid (Aβ) ● Tau Neurofibrillary Tangles (NTFs). Causes loss of neurons & critical neuronal connections.
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.
All AEs were graded as mild, moderate, severe, life-threatening, and serious (SAE). ● In all three Cohorts, a) there were no SAEs, b) no life-threatening AEs, and c) no deaths. ● One AE, mild dizziness, reported in Cohort 1, was deemed to be related to IGC-AD1.
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.
Patients can have difficulty with multi-step tasks such as getting dressed. Behavioral problems, including hallucinations, delusions, paranoia, and impulsive behavior, can also increase. When severe Alzheimer’s sets in, plaques and tangles spread throughout the patient’s brain, and the brain shrinks significantly. People with severe Alzheimer’s are completely dependent on others for care.
As the disease progresses to moderate, there is damage to the areas of the brain that control language, reasoning, sensory processing, and conscious thought. Patients can have difficulty with multi-step tasks such as getting dressed. Behavioral problems, including hallucinations, delusions, paranoia, and impulsive behavior, can also increase.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeLegal 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, the extent of such exposure can be difficult or impossible to estimate and which can negatively impact our financial condition and results of operations.
Biggest changeThese 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 engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management, and which ultimately may not be successful.
We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management, which ultimately may not be successful.
In the event that we are not covered by insurance, our management could spend significant time and resources addressing any such issues. And the legal fees necessary to defend against multiple lawsuits can be significant, impacting the Company’s overall bottom line when not covered by insurance or where the fees exceed the Company’s insurance policy limits.
In the event that we are not covered by insurance, our management could spend significant time and resources addressing any such issues. The legal fees necessary to defend against multiple lawsuits can be significant, impacting the Company’s overall bottom line when not covered by insurance or where the fees exceed the Company’s insurance policy limits.
The regulatory approval process can be affected by, among other things, the following: ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication; ● serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates, or other products containing the active ingredient in our product candidates; ● negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ● the data collected from clinical trials of our product candidates may not be acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, and/or we may be required to conduct additional clinical trials; ● the FDA or comparable foreign authorities may disagree regarding the formulation, labeling, and/or the specifications of our product candidates; ● the FDA or comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
The regulatory approval process can be affected by, among other things, the following: ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication; ● serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates or other products containing the active ingredient in our product candidates; ● negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ● the data collected from clinical trials of our product candidates may not be acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, and/or we may be required to conduct additional clinical trials; ● the FDA or comparable foreign authorities may disagree regarding the formulation, labeling, and/or specifications of our product candidates; ● the FDA or comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
In addition, the FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or patient population than we originally requested, and the FDA or applicable foreign regulatory agency may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.
In addition, the FDA or the applicable foreign regulatory agency may also approve a product candidate for a more limited indication or patient population than we originally requested, and the FDA or applicable foreign regulatory agency may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.
The market acceptance of any product depends on several factors such as the price of the product, the effect of the product, the taste of the product, reputation of the Company, competition, and marketing and distribution support.
The market acceptance of any product depends on several factors, such as the price of the product, the effect of the product, the taste of the product, the reputation of the Company, competition, and marketing and distribution support.
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 geographic scope of our product distribution.
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.
The Company orders components for its products and builds inventory in advance of product announcements and shipments. Manufacturing purchase obligations cover the Company’s forecasted component and manufacturing requirements, typically for periods up to 150 days.
The Company orders components for its products and builds inventory in advance of product announcements and shipments. Manufacturing purchase obligations cover the Company’s forecasted component and manufacturing requirements, typically for periods of up to 150 days.
These risks could increase operating costs, including the cost of our electricity and energy use, or other compliance costs. Physical risks to our operations include water stress and drought; flooding and storm surge; wildfires; extreme temperatures and storms, which could impact pharmaceutical production, increase costs, or disrupt supply chains of medicines for patients.
These risks could increase operating costs, including the cost of our electricity and energy use or other compliance costs. Physical risks to our operations include water stress and drought, flooding and storm surge, wildfires, extreme temperatures, and storms, which could impact pharmaceutical production, increase costs, or disrupt the supply chains of medicines for patients.
Control Share Acquisitions The Maryland General Corporation Law also prevents, subject to exceptions, an acquirer who acquires sufficient shares to exercise specified percentages of voting power of a corporation from having any voting rights except to the extent approved by two-thirds of the votes entitled to be cast on the matter not including shares of stock owned by the acquiring person, any directors who are employees of the corporation and any officers of the corporation.
Control Share Acquisitions The Maryland General Corporation Law also prevents, subject to exceptions, an acquirer who acquires sufficient shares to exercise specified percentages of the voting power of a corporation from having any voting rights except to the extent approved by two-thirds of the votes entitled to be cast on the matter not including shares of stock owned by the acquiring person, any directors who are employees of the corporation and any officers of the corporation.
Further, the board of directors may, by electing to be covered by the applicable statutory provisions and notwithstanding the corporation’s charter or bylaws: ● provide that a special meeting of stockholders will be called only at the request of stockholders entitled to cast at least a majority of the votes entitled to be cast at the meeting, ● reserve for itself the right to fix the number of directors, ● provide that a director may be removed only by the vote of at least two-thirds of the votes entitled to be cast generally in the election of directors, and ● retain for itself sole authority to fill vacancies created by an increase in the size of the board or the death, removal, or resignation of a director.
Further, the board of directors may, by electing to be covered by the applicable statutory provisions and notwithstanding the corporation’s charter or bylaws: ● provide that a special meeting of stockholders will be called only at the request of stockholders entitled to cast at least a majority of the votes entitled to be cast at the meeting; ● reserve for itself the right to fix the number of directors; ● provide that a director may be removed only by the vote of at least two-thirds of the votes entitled to be cast generally in the election of directors; and ● retain for itself the sole authority to fill vacancies created by an increase in the size of the board or the death, removal, or resignation of a director.
These provisions of Bylaws are intended to reduce our vulnerability to an unsolicited proposal for the restructuring or sale of all or substantially all of our assets or an unsolicited takeover attempt, which our Board believes is otherwise unfair to our stockholders.
These provisions of the Bylaws are intended to reduce our vulnerability to an unsolicited proposal for the restructuring or sale of all or substantially all of our assets or an unsolicited takeover attempt, which our Board believes is otherwise unfair to our stockholders.
Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, an inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
This focus on ESG matters may lead to new expectations or requirements that could result in increased costs associated with research, development, manufacture, or distribution of our products. Our ability to compete could also be affected by changing customer preferences and requirements, such as growing demand for companies to establish validated Net Zero targets or offer more sustainable products.
This focus on ESG matters may lead to new expectations or requirements that could result in increased costs associated with the research, development, manufacture, or distribution of our products. Our ability to compete could also be affected by changing customer preferences and requirements, such as growing demand for companies to establish validated Net Zero targets or offer more sustainable products.
Investors seeking short-term liquidity should be aware that we cannot assure that the stock price will continue at these or any higher levels. A possible “ short squeeze ” due to a sudden increase in demand of our common stock that largely exceeds supply may lead to further price volatility in our common stock.
Investors seeking short-term liquidity should be aware that we cannot assure you that the stock price will continue at these or any higher levels. A possible “ short squeeze ” due to a sudden increase in demand of our common stock that largely exceeds supply may lead to further price volatility in our common stock.
Patient enrollment and retention in clinical trials depend on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the size of the patient population required for analysis of the trial’s primary endpoints; ● the nature of the trial protocol; ● the existing body of safety and efficacy data with respect to the product candidate; ● the proximity of patients to clinical sites; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; ● competing clinical trials being conducted by other companies or institutions; ● our ability to maintain patient consents; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion.
Patient enrollment and retention in clinical trials depend on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the size of the patient population required for analysis of the trial’s primary endpoints; ● the nature of the trial protocol; ● the existing body of safety and efficacy data with respect to the product candidate; ● the proximity of patients to clinical sites; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; ● competing clinical trials being conducted by other companies or institutions; ● our ability to maintain patient consent; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion.
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.
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.
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. 34 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. 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.
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; ● 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: 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.
The failure by management to apply these funds effectively could result in financial losses, and these financial losses could have a material adverse effect on our business and cause the price of our common stock to decline.
The failure of management to apply these funds effectively could result in financial losses, and these financial losses could have a material adverse effect on our business and cause the price of our common stock to decline.
In that event, we would incur additional costs and may be deprived from generating royalties from these agreements. We may face risks relating to health care privacy and security laws.
In that event, we would incur additional costs and may be deprived of generating royalties from these agreements. We may face risks relating to health care privacy and security laws.
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.
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.
Efforts by biopharmaceutical and pharmaceutical companies in treating Alzheimer’s Disease have seen limited success in drug development, and there is no FDA-approved disease modifying therapeutic options available for patients with Alzheimer’s Disease. We cannot be certain that our approach will lead to the development of approvable or marketable products.
Efforts by biopharmaceutical and pharmaceutical companies in treating Alzheimer’s Disease have seen limited success in drug development, and there are no FDA-approved disease-modifying therapeutic options available for patients with Alzheimer’s Disease. We cannot be certain that our approach will lead to the development of approvable or marketable products.
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. 33 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. 32 Table of Contents We do not anticipate declaring any cash dividends on our common stock.
Although nine patents have been issued, there is no guarantee that our remaining applications will result in a successful registration with the USPTO. If we are unsuccessful in registering patents, our ability to create a valuable line of products can be adversely affected.
Although twelve patents have been issued, there is no guarantee that our remaining applications will result in a successful registration with the USPTO. If we are unsuccessful in registering patents, our ability to create a valuable line of products can be adversely affected.
This in turn may have a material and adverse impact on the trading price of our common stock. 29 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. 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.
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. 30 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. 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.
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. 23 Table of Contents 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. We continue to monitor the global trade environment and potential trade conflicts and impediments that could impact our business.
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 manufactures as being suitable for the production of our products and product candidates.
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.
Because the Company’s markets are volatile, competitive, and subject to rapid technology and price changes, there is a risk the Company will forecast incorrectly and order or produce excess or insufficient amounts of components or products, or not fully utilize firm purchase commitments. 31 Table of Contents Our accounting personnel may make unintentional errors.
Because the Company’s markets are volatile, competitive, and subject to rapid technology and price changes, there is a risk the Company will forecast incorrectly and order or produce excess or insufficient amounts of components or products or not fully utilize firm purchase commitments. Our accounting personnel may make unintentional errors.
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; ● 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; 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.
Any one of these factors could slow or halt the use and handling of cannabinoids in the U.S. or in other jurisdictions, which would negatively impact our development of phytocannabinoids-based therapies and our ability to test and productize these therapies. 24 Table of Contents Many U.S. state laws conflict with the federal Controlled Substances Act.
Any one of these factors could slow or halt the use and handling of cannabinoids in the U.S. or in other jurisdictions, which would negatively impact our development of phytocannabinoids-based therapies and our ability to test and productize these therapies. Many U.S. state laws conflict with the federal Controlled Substances Act.
If our Board chose to implement the statutory provisions, it could further discourage offers to acquire our common stock and could further increase the difficulty of completing an offer to acquire our common stock.
If our Board chooses to implement the statutory provisions, it could further discourage offers to acquire our common stock and could further increase the difficulty of completing an offer to acquire our common stock.
Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. 26 Table of Contents We have concentrated our research and development efforts on the treatment of Alzheimer ’ s Disease, which has seen limited success in drug development.
Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. We have concentrated our research and development efforts on the treatment of Alzheimer ’ s Disease, which has seen limited success in drug development.
A person is not an interested stockholder if the board of directors approved in advance the transaction by which the person otherwise would have become an interested stockholder.
A person is not an interested stockholder if the board of directors approves in advance the transaction by which the person otherwise would have become an interested stockholder.
Failure to supply our partners with commercial products may lead to adverse consequences. 28 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.
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.
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 $0.31 and a high of $0.94 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 $0.46 per share.
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 have had a history of operating losses. For Fiscal 2023 and Fiscal 2022, we had a net loss of approximately $11.5 million and $15 million, respectively. Our revenue increased from Fiscal 2022 to Fiscal 2023. Our short-term focus is to gain market share for our Life Sciences segment.
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.
We may not successfully register the provisional patents with the USPTO. We have filed forty-one (41) 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 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.
Any of these occurrences may harm our business, financial condition, and prospects significantly. 27 Table of Contents Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; ● regulatory authorities may withdraw approvals of such product; ● regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication; ● we may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients; ● we could be sued and held liable for harm caused to patients; ● the product may become less competitive; and ● our reputation may suffer.
Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; ● regulatory authorities may withdraw approvals of such products; ● regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication; ● we may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients; ● we could be sued and held liable for harm caused to patients; ● the product may become less competitive; and ● our reputation may suffer.
Our supply chain is likely subject to these same transitional and physical risks and would likely pass along any increased costs to us. We do not anticipate that these risks will have a material financial impact on the Company in the near term.
Our supply chain is likely subject to these same transitional and physical risks and would likely pass along any increased costs to us. We do not anticipate that these risks will have a material financial impact on the Company in the near term, although there can be no assurance.
Our lines of business and services, but especially our development of hemp-based cannabinoid combination therapies for products, including Hyalolex™, Drops of Clarity™, and our long-term use and/or development of blockchain technologies to solve critical issues facing the cannabinoids industry, rely on services hosted and controlled directly by our suppliers and distributors and their third-party service providers.
Our lines of business and services, but especially our development of hemp-based cannabinoid combination therapies for products, and our long-term use and/or development of software to solve critical issues facing the pharmaceutical industry, rely on services hosted and controlled directly by our suppliers and distributors and their third-party service providers.
If we cannot achieve profitability, the market price of our common stock could decline significantly. As of March 31, 2023, we had cash and cash equivalents of $3.2 million and working capital of $4.6 million compared to cash and cash equivalents of $10.5 million and working capital of $12.7 million as of March 31, 2022, for continuing operations.
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 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. 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 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. 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.
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. These possible sanctions would adversely affect our business, the results of operations, and financial condition.
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.
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.
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.
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.
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.
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. If any of these events occur, they could negatively impact our revenues, which could prevent us from achieving or sustaining profitability.
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.
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.
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.
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.
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.
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. Violations of financial regulation laws are subject to civil, and, in some cases, criminal sanctions.
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.
Some, but not all, of the factors that could affect our ability to achieve results are described in forward-looking statements. 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.
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.
Furthermore, we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we have agreements governing their committed activities, we have limited influence over their actual performance. 25 Table of Contents The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for IGC-AD1 or any other product candidates, our business will be substantially harmed.
The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for IGC-AD1 or any other product candidates, our business will be substantially harmed.
For diseases like Alzheimer’s, the FDA has stated that one single Phase 3 trial is adequate for approval if it demonstrates robust and unquestionable efficacy. 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.
For diseases like Alzheimer’s, the FDA has stated that one single Phase 3 trial is adequate for approval if it demonstrates robust and unquestionable efficacy.
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. Both marijuana and hemp produce other cannabinoids, such as CBD.
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.
While we strive to ensure compliance, further tightening of these definitions may have an adverse impact on our products. 22 Table of Contents 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.
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.
If such an event were to occur, it could have an adverse effect on our business and financial results. 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.
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.
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. A pandemic, epidemic, or outbreak of infectious disease, such as COVID-19, may materially and adversely affect our business and operations.
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.
Removed
No assurance can be given that we can raise any such financing, and such financing could be dilutive to our shareholders. Our cannabinoid strategy makes it difficult to raise money as a public company. 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.
Added
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.
Removed
The Company established a Good Manufacturing Practice (GMP) certified processing facility in the State of Washington for processes such as: a) production of products such as lotions, creams, and oils, among others, to support our products and to support white labeling; b) extraction of hemp into crude oil; and c) distillation of crude oil into hemp extracts.
Added
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.
Removed
Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
Added
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.
Removed
Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.
Added
For example, our AI-related efforts, particularly those related to generative AI, subject us to risks related to harmful content, accuracy, bias, discrimination, toxicity, intellectual property infringement or misappropriation, defamation, data privacy, cybersecurity, and sanctions and export controls, among others.
Removed
The COVID-19 pandemic is affecting the United States and global economies and has and may continue to affect our operations and those of third parties on which we rely, including by causing disruptions in the supply of our products candidates and the conduct of current and future clinical trials.
Added
It is also uncertain how various laws related to online services, intermediary liability, and other issues will apply to content generated by AI.
Removed
As the end of the COVID-19 pandemic remains unknown, the full extent of the impact of COVID-19 on the Company remains unknown as well. The impact of COVID-19 on our operations is reflected in reduced revenue and increased expenses in both our Infrastructure and the Life Sciences segments.
Added
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. 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.
Removed
In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with respect to our product candidates.
Added
We may not always be able to anticipate how to respond to these frameworks, given that they are still rapidly evolving. We may also have to expend resources to adjust our offerings in certain jurisdictions if the legal frameworks on AI are not consistent across jurisdictions.
Removed
The evolving COVID-19 pandemic is also likely to directly or indirectly impact the pace of enrollment in our clinical trial for IGC-AD1 for at least the next several months and possibly longer as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency.
Added
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.
Removed
Such facilities and offices may also be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, and may not be available, in whole or in part, for clinical trial services or our other product candidates.
Added
Furthermore, we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials, and while we have agreements governing their committed activities, we have limited influence over their actual performance.
Removed
Additionally, while the potential economic impact brought by, and the duration of the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity.

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Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

6 edited+3 added−1 removed3 unchanged
Biggest changeOn 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, after the close of the Company’s fiscal year, Apogee and Clarke filed a response to the motion.
Biggest changeOn 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.
On June 28, 2021, Apogee and Clarke filed an amended complaint. On July 23, 2021, IGC and Mukunda moved to partially dismiss the counterclaim and the Apogee Litigation.
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.
As of March 31, 2023, 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.
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.
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, 2023.
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.
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. The court is expected to issue a decision sometime during fiscal year 2024 (on or before March 31, 2024).
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.
ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 36 Table of Contents PART II
In 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
Removed
The Company considers the counterclaim and the Apogee Litigation to be ordinary, routine litigation incidental to the business. The Company and Mukunda deny any and all liability and, in particular, deny many of the factual allegations contained in the Apogee Litigation. Both the Company and Mukunda intend to vigorously defend the litigation and are represented by counsel for that purpose.
Added
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.
Added
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.
Added
The Company filed a complaint against four (4) individuals with the Prosecutor's Office 393 Sectional Economic Crimes Unit, Bogota, Colombia, under file no. 110016000050202247710 for charges of fraud, falsification of a private document, and conspiracy to commit a crime. The complaint was filed in 2022.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(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, and 3 million shares as special grant of common stock, as approved by stockholders on September 9, 2022.
Biggest change(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.
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 (in thousands), as of March 31, 2023, 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, 2024, information regarding outstanding awards available under our compensation plans (including individual compensation arrangements) under which our equity securities may be delivered.
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. Unregistered sales of equity securities None.
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.
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) - $ - - Special Grant (2) 5,696 $ 0.98 2,280 (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) 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.
Holders of Record As of July 6, 2023, we had approximately 37 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 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.
Removed
Purchases of equity securities by the issuer and affiliated purchasers None.
Added
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
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.
Added
Shares 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]

Item 7. Management's Discussion & Analysis

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

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Biggest changeSubject to further research and study, the combination is intended to reduce side effects caused by hydantoin anticonvulsant drugs such as phenobarbital, by reducing the dosing of anticonvulsant drugs in humans, dogs, and cats. 41 Table of Contents Results of Operations Fiscal 2023 compared to Fiscal 2022 The following table presents an overview of our results of operations for Fiscal 2023 and Fiscal 2022: Statement of Operations (in thousands, audited) Fiscal 2023 ($) 2022 ($) Change ($) Percent Change Revenue 911 397 514 129 Cost of revenue (469 ) (203 ) (266 ) 131 Gross profit 442 194 248 128 Selling, general and administrative expenses (8,552 ) (13,292 ) 4,740 (36 ) Research and development expenses (3,461 ) (2,330 ) (1,131 ) 49 Operating loss (11,571 ) (15,428 ) 3,857 (25 ) Impairment - (49 ) 49 (100 ) Other income, net 65 461 (396 ) (86 ) Loss before income taxes (11,506 ) (15,016 ) 3,510 (23 ) Income tax expense/benefit - - - - Net loss attributable to common stockholders (11,506 ) (15,016 ) 3,510 (23 ) Revenue – During Fiscal 2023, the Company generated approximately $911 thousand in revenue, representing a significant increase from the $397 thousand generated in Fiscal 2022.
Biggest changeResults of Operations Fiscal 2024 compared to Fiscal 2023 The following table presents an overview of our results of operations for Fiscal 2024 and Fiscal 2023: Statement of Operations (in thousands, audited) Fiscal 2024 ($) 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.
Investing Activities 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.
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.
Revenue from the execution of infrastructure contracts is recognized on the basis of the output method as and when part of the performance obligation has been completed and approval from the contracting agency has been obtained after survey of the performance completion as of that date.
Revenue from the execution of infrastructure contracts is recognized on the basis of the output method as and when part of the performance obligation has been completed and approval from the contracting agency has been obtained after a survey of the performance completion as of that date.
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 Company 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 2023 ending on March 31, 2023, and Fiscal 2022, ending on March 31, 2022.
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.
Complying with these security measures and compliances is expected to incur further expenses. In Fiscal 2023 and Fiscal 2022, 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 2024 and Fiscal 2023, there were no known or detected breaches in cybersecurity. Recently issued and adopted accounting pronouncements Changes to U.S.
Factors in the global economic environment that may impact our operations include, among other things, currency fluctuations, capital and exchange controls, global economic conditions including inflation, 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 our products, as well as impacts of political or civil unrest or military action, including 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.
Factors in the global economic environment that may impact our operations include, among other things, currency fluctuations, capital and exchange controls, global economic conditions including inflation, 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 our products, as well as impacts of political or civil unrest or military action, terrorist activity, unstable governments, and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.
The core principle of this standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. 44 Table of Contents ASC 606 prescribes a 5-step process to achieve its core principle.
The core principle of this standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. ASC 606 prescribes a 5-step process to achieve its core principle.
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 and sales of branded holistic women’s health care 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. The growth can be attributed to higher sales volume driven by increased sales and marketing efforts.
Net cash provided by financing activities was approximately $4.1 million for Fiscal 2022, which comprises net proceeds from issuance of equity stock through the ATM offering, net of all expenses related to the issuance of stock. 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 $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.
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.
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 $15 million, a positive impact on cash due to non-cash expenses of approximately $5 million, and changes in operating assets and liabilities of approximately $2.5 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.
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. Net cash used in operating activities for Fiscal 2022 was approximately $7.5 million.
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 $0.1 million decrease in other net current assets and liabilities.
Net sales disaggregated by significant products and services for Fiscal 2023 and 2022 are as follows: (in thousands) Year Ended March 31 2023 ($) 2022 ($) Infrastructure segment Rental income (1) 37 23 Construction contracts (2) 76 15 Life Sciences segment Wellness and lifestyle (3) 416 316 White label services (4) 382 43 Total 911 397 (1) Rental income consists of income from rental of heavy construction equipment.
Net sales disaggregated by significant products and services for Fiscal 2024 and 2023 are as follows: (in thousands) Year Ended March 31 2024 ($) 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.
Actual results may differ from these estimates, and such differences may be material. Management believes that the following accounting policies are the most critical to understanding and evaluating our consolidated financial condition and results of operations. Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers (ASC 606).
Management believes that the following accounting policies are the most critical to understanding and evaluating our consolidated financial condition and results of operations. Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers (ASC 606).
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 2023, the Company reported R&D expenses of approximately $3.5 million, representing an increase of $1.2 million or 49% compared to approximately $2.3 million in Fiscal 2022.
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.
(2) Construction income consists of the execution of contracts directly or through subcontractors. (3) Revenue from wellness and lifestyle consists of sale of products such as gummies, hand sanitizers, bath bombs, lotions, beverages, hemp crude extract, hemp isolate, and hemp distillate. (4) Revenue from white label services consists of rebranding our formulations or the customer’s products as per customer’s requirement.
(2) Construction income consists of the execution of contracts directly or through subcontractors. (3) 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 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, 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 Year ended March 31, 2022 INR 74.50 Per USD INR 75.91 Per USD HKD 7.78 Per USD HKD 7.83 Per USD COP 3,830 Per USD COP 3,748 Per USD 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, 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 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.
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.
Dollar (“USD”), the INR, the HKD, or the COP affect financial statements. 47 Table of Contents 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, 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.
In addition, changes in operating assets and liabilities had a positive impact of approximately $2.5 million in cash, of which approximately $1.9 million is due to an adjustment in inventory and an approximately $0.6 million increase in accounts payable.
In addition, changes in operating assets and liabilities had a positive impact of approximately $1.9 million on cash, of which approximately $1 million is due to an adjustment in inventory, approximately $243 thousand increase in accounts payable, approximately $315 thousand increase in claims and advances and approximately $328 thousand increase in other net current assets.
(in thousands, audited) As of March 31, 2023 ($) As of March 31, 2022 ($) Change ($) Percent Change Cash, cash equivalents 3,196 10,460 (7,264 ) (69 )% Working capital 4,568 12,670 (8,102 ) (64 )% Cash and cash equivalents Cash and cash equivalents decreased by approximately $7.3 million to $3.2 million in Fiscal 2023 from $10.5 million in Fiscal 2022, a decrease of approximately 69% is discussed in the summary of cash flows, as follows: (in thousands, audited) Fiscal 2023 ($) 2022 ($) Change ($) Percent Change Cash used in operating activities (7,047 ) (7,462 ) 415 (6 )% Cash used in investing activities (235 ) (742 ) 507 (68 )% Cash provided by financing activities 100 4,142 (4,042 ) (98 )% Effects of exchange rate changes on cash and cash equivalents (82 ) (26 ) (56 ) 215 % Net decrease in cash and cash equivalents (7,264 ) (4,088 ) (3,176 ) 78 % Cash and cash equivalents at the beginning of the period 10,460 14,548 (4,088 ) (28 )% Cash and cash equivalents at the end of the period 3,196 10,460 (7,264 ) (69 )% 43 Table of Contents Operating Activities Net cash used in operating activities for Fiscal 2023 was approximately $7 million.
(in thousands, audited) As of March 31, 2024 ($) 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.
Selling, general and administrative expenses – Selling, general, and administrative (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 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.
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 a result, changes in the relative values of the U.S.
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”).
See Item 1A, “Risk Factors” for further discussion of the possible impact of the COVID-19 pandemic on our business. The Global Economic Environment In addition to the industry-specific factors, such as regulations around cannabinoid research, we are exposed to economic cycles.
The Global Economic Environment In addition to the industry-specific factors, such as regulations around cannabinoid research, we are exposed to economic cycles.
For Fiscal 2023, the Company reported SG&A expenses of approximately $8.5 million, representing a decrease of approximately $4.7 million, or 36%, compared to the $13.2 million recorded in Fiscal 2022.
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.
The Company implemented robust marketing and sales activities, which contributed to the successful expansion of its customer base and increased demand. Approximately 10%-12% of revenue in both years was derived from the Infrastructure segment. The Company remains committed to its current strategy of driving sales in formulated white labeled and wellness products.
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.
Financing Activities Net cash provided by financing activities was approximately $0.1 million for Fiscal 2023, which comprises net proceeds from issuance of equity stock through the ATM offering, net of all expenses related to the issuance of stock.
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.
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.
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, 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 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.
By continuing to focus on sales and marketing initiatives, the Company aims to further strengthen its position in the market and drive sustained revenue growth. Cost of revenue – The cost of revenue amounted to approximately $469 thousand for Fiscal 2023, compared to $203 thousand in Fiscal 2022. This represents a gross margin of about 49% for both years.
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.
Net cash used in investing activities for Fiscal 2022, was approximately $0.7 million, which comprises approximately $0.5 million for the acquisition and filing expenses related to intellectual property, approximately $0.2 million for the purchase of property, plant, and equipment.
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.
IGC-AD1, described above, is based on some of this research. ● On June 7, 2022, the USPTO issued a patent (#11,351,152) to the Company titled “Method and Composition for Treating Seizures Disorders.” The patent relates to compositions and methods for treating multiple types of seizure disorders and epilepsy in humans and animals using a combination of the CBD with other compounds.
The patent relates to compositions and methods for treating multiple types of seizure disorders in humans using a combination of cannabinoids with other compounds.
In Fiscal 2022, there was an impairment of approximately $49 thousand, which was attributed to the cancelation of 44 thousand shares of IGC common stock. 42 Table of Contents Other Income, net – During Fiscal 2023, the Company reported approximately $65 thousand in other income, which represents a decrease compared to the $461 thousand recorded in Fiscal 2022.
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.
Non-cash expenses consist of an amortization/depreciation charge of approximately $0.6 million, impairment of investment of $0.1 million, provision against debtor & advances of $1.7 million, stock-based expenses of approximately $2.2 million, and a one-time impairment of PPE of $0.8 million and an offset of $0.4 million due to the forgiveness of a PPP Loan.
Non-cash expenses consist of an amortization and depreciation charge of approximately $637 thousand, stock-based expenses of approximately $1.7 million, impairment loss of approximately $3.4 million, and an approximately $49 thousand decrease in other non-cash items.
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Overview IGC Pharma, Inc. is a clinical-stage pharmaceutical company with a diversified revenue model that develops both prescription drugs and over-the-counter (OTC) products. Our focus is on developing innovative therapies for neurological disorders such as Alzheimer’s disease, epilepsy, Tourette syndrome, and sleep disorders.
Added
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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We also focus on formulations for eating disorders, chronic pain, premenstrual syndrome (PMS), and dysmenorrhea, in addition to health and wellness OTC formulations. The Company is developing its lead candidate, IGC-AD1, an investigational oral therapy for the treatment of agitation associated with Alzheimer’s disease.
Added
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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IGC-AD1 is currently in Phase 2 (Phase 2B) clinical trials after completing nearly a decade of research and realizing positive results from pre-clinical and a Phase 1 trial.
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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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This previous research into IGC-AD1 has demonstrated efficacy in reducing plaques and tangles, which are two important hallmarks of Alzheimer’s, as well as reducing neuropsychiatric symptoms associated with dementia in Alzheimer’s disease, such as agitation. We were formerly known as India Globalization Capital, Inc. and incorporated in Maryland on April 29, 2005.
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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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Our fiscal year is the 52- or 53-week period ending March 31. Currently, most of our revenue comes from the Life Sciences segment and, in the future, we believe, from our investigational drugs for treating Alzheimer’s disease.
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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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We have also built a facility for a potential Phase 3 trial and have strategic relations for the procurement of Active Pharmaceutical Ingredients (APIs). In addition, we have acquired and initiated work on TGR-63, a pre-clinical molecule that exhibits an impressive affinity for reducing neurotoxicity in Alzheimer’s cell lines.
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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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The advancement of IGC-AD1 into Phase 2 trials represents a significant milestone for the company and positions us for multiple pathways to future success. Although there can be no assurance, we anticipate that the positive outcomes from these and other trials will drive further growth, valuation, and market potential for IGC-AD1. IGC has two segments: Life Sciences and Infrastructure.
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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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Life Sciences Segment Pharmaceutical : Since 2014, we have focused a portion of our business on the application of phytocannabinoids such as THC and CBD, among others, in combination with other compounds, to address efficacy for various ailments and diseases such as Alzheimer’s disease.
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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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As previously disclosed, IGC submitted IGC-AD1, our investigational drug candidate for Alzheimer’s, to the FDA under Section 505(i) of the Federal Food, Drug, and Cosmetic Act and received approval on July 30, 2020, to proceed with the Phase 1 trial on Alzheimer’s patients and the Company completed all dose escalation studies, and as announced by the Company on December 2, 2021, the results of the clinical trial have been submitted in the Clinical/Statistical Report (CSR) filed with the FDA.
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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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The Company is motivated by the potential that, with future successful results from appropriate further trials, IGC-AD1 could contribute to relief for some of the 55 million people around the world expected to be impacted by Alzheimer’s disease by 2030 (WHO, 2021). 38 Table of Contents Currently, IGC-AD1 is in a Phase 2B safety and efficacy clinical trial for agitation in dementia from Alzheimer’s (clinicaltrials.gov, NCT05543681).
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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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The progress we are making in the clinic, gives us confidence in the potential of IGC-AD1 as a potentially groundbreaking therapy, with the potential to treat Alzheimer’s and also to manage devastating symptoms that separate families, increase admissions to nursing homes, and drive the cost of Alzheimer’s care, although there can be no assurance.
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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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We have a two-pronged approach for our Alzheimer’s investigational drug development strategy, the first prong is to investigate IGC-AD1 as an Alzheimer’s symptoms modifying agent, and the second is to investigate TGR-63 as a disease modifying agent.
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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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This involves conducting more trials on IGC-AD1 over the next few years, subject to FDA approval, with the anticipated goal of demonstrating safety and efficacy and potentially obtaining FDA approval for IGC-AD1 as a cannabinoid-based new drug that can help to manage agitation for patients suffering from Alzheimer’s disease.
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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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The second prong is to investigate the potential efficacy of TGR-63 on memory and/or decreasing or managing plaques and tangles, some of the hallmarks of Alzheimer’s disease. Our pipeline of investigational and development cannabinoid formulations also includes pain creams and tinctures for pain relief.
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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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We believe that the pharmaceutical component of our Life Sciences strategy will take several more years to mature and involves considerable risk; however, we also believe it may involve greater defensible growth potential and first-to-market advantage.
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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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Although there can be no assurance, we believe that additional investment in clinical trials, research, and development (R&D), facilities, marketing, advertising, and acquisition of complementary products and businesses supporting our Life Sciences segment will be critical to the development and delivery of innovative products and positive patient and customer experiences.
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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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We hope to leverage our R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through planned pre-clinical and clinical trials.
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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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Although there can be no assurance, we believe this strategy has the potential to improve existing products and lead to the creation of new products, which, based on scientific study and research, may offer positive results for the management of certain conditions, symptoms, and side effects.
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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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While the bulk of our medium and longer-term focus is on clinical trials and getting IGC-AD1 to be an FDA approved drug, our shorter-term strategy, is to use our resources to provide white label services and market Holief™. We believe this may provide us with several profit opportunities, although there can be no assurance of such profit opportunities.
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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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Over-the-Counter Products : We have created a women’s wellness brand, Holief™ available through online channels that are compliant with relevant federal, state, and local laws, and regulations. Holief™ is an all-natural, non-GMO, vegan, line of over-the-counter (OTC) products aimed at treating menstrual cramps (dysmenorrhea) and premenstrual symptoms (PMS). The products are available online and through Amazon and other online channels.
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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.
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Holief™ is compliant with relevant federal, state, and local laws, and regulations. Infrastructure Segment The Company’s infrastructure business has been operating since 2008, it includes: (i) Execution of Construction Contracts and (ii) Rental of Heavy Construction Equipment.
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The Company believes it can sell the above-said non-operating land as it is without any improvement. Selling this land will give immediate cash, which the Company can use in its operating segments. During Fiscal 2023, there was no impairment loss on PPE.
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COVID-19 Update The ongoing COVID-19 pandemic and the resulting containment measures that have been in effect from time to time in various countries and territories since early 2020 have had a number of substantial negative impacts on businesses around the world and on global, regional, and national economies, including widespread disruptions in supply chains for a wide variety of products and resulting increases in the prices of many goods and services.
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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.
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Currently, our production facilities in all of our locations continue to operate as they had before the COVID-19 pandemic, with few changes other than for enhanced safety measures intended to prevent the spread of the virus.

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