| Nature of Operations [Text Block] | NOTE
1 BUSINESS DESCRIPTION Overview IGC
Pharma, a clinical-stage company developing treatments for Alzheimer’s disease, is committed to transforming patient care by striving
to offer faster-acting and more effective solutions. Our leading drug candidate, IGC-AD1, embodies this vision by tackling a critical
challenge – managing agitation in Alzheimer’s dementia. Early results from our Phase 2 trial are promising: IGC-AD1 effectively
reduced agitation in patients compared to a placebo, and crucially, it did so faster than traditional medications. While existing anti-psychotics
can take as long as 6 to 12 weeks to show effects, IGC-AD1 has the potential to act within 2 weeks. This significantly faster onset of
action could significantly improve patient care and represents a potential breakthrough in managing Alzheimer’s-related agitation,
although there can be no assurance thereof. We
currently have five platforms, each with a core molecule that can be modified. For example, the TGR family consists of many molecules,
such as TGR-60, TGR-61, and TGR-63. TGR-63 targets plaques in Alzheimer’s. Similarly, the IGC-C and IGC-M platforms consist of
many molecules. The Alzheimer’s targeting molecule from each of our platforms is set forth below, the effects of which are subject
to clinical trial and investigation:
● IGC-AD1:
● TGR-63:
● IGC-1C:
● IGC-M3:
● LMP:
A
goal of IGC’s, in addition to advancing our drugs through the clinical trial, is to also drive near to mid-term revenue growth.
We have made considerable investments to date across our platform in our consumer products division, artificial intelligence (“AI”),
and our internal Customer Relationship Management (“CRM”). It is our view that there is an opportunity to drive revenue growth
in these parts of our business without significant future capital investment. We
are also developing AI models for predicting early Alzheimer’s detection biomarkers, optimizing clinical trials, and to help us
explore new disease applications for different molecules. For example, our AI models are being developed to predict the probability that
our molecules can work on other receptors, such as GLP1 (neurological disorders, weight loss), CB1 (neuropsychiatric conditions), among
others. Additionally, our 30 patent filings, including for IGC-AD1, demonstrate our commitment to innovation and protecting our intellectual
property. Collectively, these core assets and initiatives underscore our commitment to advancing the field of pharmaceuticals, delivering
groundbreaking treatments, and creating lasting value for our investors. We remain steadfast in our pursuit of excellence and our mission
to improve the lives of those affected by Alzheimer’s and related conditions. Phase
2 Clinical Trial 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 study is powered to include 146 Alzheimer’s patients; as a superiority trial with parallel groups;
half of the participants will receive a placebo, and the other half will receive IGC-AD1. The
primary and secondary endpoints are the mean change in agitation scores from baseline, compared to placebo, as assessed by the Cohen-Mansfield
Agitation Inventory (“CMAI”) in Alzheimer’s patients after 6 weeks of treatment and the mean change in CMAI scores
after 2 weeks of treatment, respectively. Agitation is rated at the trial site, at baseline, week 2, and week 6, by a trained practitioner
using the CMAI, a scale designed and widely used to measure agitation in Alzheimer’s dementia (“AAD”) in clinical trials.
The IGC-AD1 Phase 2 is an ongoing clinical trial that continues to enroll. IGC-AD1 is an oral liquid formulation administered twice daily
(“bid”) for six weeks with no placebo run-in and titration to full dose over two days. To date over 1,000 oral doses have
been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1. The investigational product
potentially targets different pathways implicated in agitation in Alzheimer’s dementia (“AAD”), including CB1 receptor
dysfunction, neuroinflammation, and neurotransmitter imbalance. AI
/ Machine Learning ( ML ) In
our pursuit of innovation, we leverage AI and ML. AI refers to the development of intelligent systems that can learn and act autonomously.
ML is a branch of AI that allows computers to learn from data without the need for explicit programming. This technology plays a role
in our efforts and could allow companies our size to do what previously was the domain of much larger pharmaceutical companies. For instance,
we are utilizing ML by training transformers, a powerful neural network architecture, to analyze vast datasets from our Phase 1 and unblinded
Phase 2 interim clinical trial to identify patterns and optimize the clinical trial protocol for a potential Phase 3 trial. The AI model,
for example, can tell us if a particular neuropsychiatric scale that we used in Phase 1 and Phase 2 added valuable information to the
trial, and if it did not, we could remove that scale from a future Phase 3 trial, thus saving money and time in the overall trial management.
In the long term, with more data, the trained AI model could allow us to consider incoming patient signatures, such as scans, symptoms,
patient history, among others and predict outcomes for our drug, including adverse effects, thus personalizing the delivery of IGC-AD1,
of which there can be no assurance. Additionally,
we are developing AI models that help us explore potential applications of molecules from our platforms beyond their initial Alzheimer’s
targets; we know that TGR-63 and IGC-M3 target plaques in Alzheimer’s, however, AI models could help us consider applications of
TGR-60, TGR-61, IGC-M1, IGC-M2, and many others. For example, we are investigating whether our molecules might interact with other receptors,
like GLP-1. GLP-1 is a receptor linked to regulating blood sugar and is increasingly being studied for its potential role in neurological
disorders, in addition to its established role in weight management. A successful link between our molecules and other targets potentially
expands our opportunities, as some of these other markets, such as the weight loss market, are considerably larger than the Alzheimer’s
market. These applications could potentially lead, if proven in future clinical trials, to new treatment avenues and broader market reach
for our molecules. This analysis also potentially allows us to prioritize work on our molecules and optimize our resources. Business
Organization As
of December 31, 2024, the Company had the following operating subsidiaries: IGCare LLC, HH Processors, LLC, IGC Pharma, LLC, IGC Pharma
IP, LLC, SAN Holdings, LLC, Sunday Seltzer, LLC, Hamsa Biopharma India Pvt. Ltd., Techni Bharathi Private Limited (TBL), and Colombia-based
beneficially-owned subsidiary IGC Pharma SAS. The Company’s fiscal year is the 52- or 53-week period that ends on March 31. IGC
has two business segments: Life Sciences Segment and Infrastructure Segment. For more information on the business segments, please refer
to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. The Company’s
principal office is in Maryland, established in 2005. Additionally, the Company has offices in Washington state, Colombia, South America,
and India. The Company’s filings are available on www.sec.gov |
