SEC Form 10-KT filed by IGC Pharma Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-KT

☐ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

☒ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from April 1, 2025 to December 31, 2025

Commission file number: 001-32830

IGC PHARMA, INC.

(Exact Name of Registrant as Specified in Its Charter)

(301) 983-0998

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act: None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☑ No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ☐ Yes ☑ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☑  Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☑  Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management assessment of the effectiveness of its Internal Control Over Financial Reporting under section 404 (b) of the Sarbanes-Oxley by the registered public accounting firm that prepared or issued its annual report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☑  No

The aggregate market value of the voting and non-voting stock held by non-affiliates of the Registrant, as of June 30, 2025, the last business day of the Registrant’s most recently completed second fiscal quarter, was approximately $18,462,163. Solely for the purposes of this disclosure, shares of common stock held by executive officers and directors of the Registrant as of such date have been excluded because such persons may be deemed to be affiliates. This determination of executive officers and directors as affiliates is not necessarily a conclusive determination for any other purposes.

98,796,089 shares of our common stock were outstanding as of March 11, 2026.

DOCUMENTS INCORPORATED BY REFERENCE

IGC PHARMA, INC.

FORM 10-KT

For the Transition Period from April 1, 2025 to December 31, 2025

TABLE OF CONTENTS

FORWARD-LOOKING STATEMENTS AND IMPORTANT FACTORS 

This Transition Report on Form 10-KT and the documents incorporated in this report by reference contain “forward-looking statements” within the meaning of federal securities laws. Additionally, we or our representatives may, from time to time, make other written or verbal forward-looking statements. In this report and the documents incorporated by reference, we discuss plans, expectations, and objectives regarding our business, financial condition, and results of operations. Without limiting the foregoing, statements that are in the future tense, and all statements accompanied by terms such as “believe,” “could,” “hope,” “potential”, “project,” “expect,” “trend,” “estimate,” “forecast,” “assume,” “intend,” “plan,” “target,” “anticipate,” “outlook,” “preliminary,” “will likely result,” “will continue,” and variations of them and similar terms are intended to be “forward-looking statements” as defined by federal securities laws. We caution you not to place undue reliance on forward-looking statements, which are based upon assumptions, expectations, plans, and projections. In addition, our goals and objectives are aspirational and are not guarantees or promises that such goals and objectives will be met. Forward-looking statements are subject to risks and uncertainties, including those identified in the “Risk Factors” included in this report and in the documents incorporated by reference that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date when they are made. Except as required by law, we assume no obligation to update forward-looking statements to reflect events, circumstances, changes in expectations, or the occurrence of unanticipated events after the date of those statements. 

Forward-looking statements are based upon, among other things, our assumptions with respect to: 

You should consider the limitations on, and risks associated with, forward-looking statements and not unduly rely on the accuracy of predictions contained in such forward-looking statements. As noted above, these forward-looking statements speak only as of the date when they are made. Moreover, in the future, we may make forward-looking statements through our senior management that involve the risk factors and other matters described in this report, as well as other risk factors subsequently identified, including, among others, those identified in our filings with the SEC in our quarterly reports on Form 10-Q and our current reports on Form 8-K. 

This document contains statements and claims that are not approved by the FDA, including statements on hemp and hemp extracts, including cannabinoids. These statements and claims are intended to be in compliance with federal and state laws. 

PART I

Unless the context requires otherwise, all references in this report to “IGC,” “IGC Pharma,” “the Company,” “we,” “our,” and “us” refer to IGC Pharma, Inc., together with our subsidiaries and beneficially owned subsidiary. Our public filings with the Securities and Exchange Commission, the “SEC,” are available on www.sec.gov. The information contained on our various websites, including www.igcpharma.com, is not incorporated by reference in this report, and you should not consider such information to be a part of this report. We exclude our investments and minority non-controlling interests, and any information provided by them is not incorporated by reference in this report, and you should not consider such information to be a part of this report. 

ITEM 1. BUSINESS

Overview

 IGC Pharma, Inc. is a clinical-stage biotechnology company focused on the development of novel therapeutic candidates for neuropsychiatric and neurodegenerative disorders, with a primary emphasis on Alzheimer’s disease. Our core strategy is to address high-burden symptoms and underlying disease mechanisms through differentiated pharmaceutical formulations, supported by targeted clinical development and data-driven research approaches.

Our lead product candidate, IGC-AD1, is currently being evaluated in a Phase 2 clinical trial for the treatment of agitation in Alzheimer’s dementia, a neuropsychiatric condition affecting a substantial proportion of patients and associated with significant patient distress, caregiver burden, and healthcare utilization. In addition to symptom management, preclinical studies of IGC-AD1 suggest activity against biological pathways associated with Alzheimer’s disease pathology, supporting its potential evaluation in broader disease-modifying contexts.

Beyond IGC-AD1, our development pipeline includes additional early-stage therapeutic candidates targeting Alzheimer’s disease mechanisms, including TGR-63 and other investigational compounds currently in preclinical evaluation. These programs are intended to expand our long-term development portfolio while maintaining a disciplined focus on clinical execution and capital efficiency.

The Company is also developing MINT-AD, a proprietary, artificial intelligence, enabled data platform designed to support risk stratification and longitudinal assessment in Alzheimer’s disease using multimodal datasets. MINT-AD is intended as a clinical and research decision-support tool and is not currently approved as a diagnostic device.

We operate as a clinical-stage organization and do not currently generate revenue from pharmaceutical product sales. Our limited revenue to date has primarily been derived from life sciences related activities outside of our core drug development programs. Our operations are funded through equity financings, debt facilities, and strategic capital allocation, and we expect to continue to incur operating losses as we advance our clinical and research programs.

IGC is a Maryland corporation formed in 2005. Our corporate headquarters is located in Potomac, Maryland, with a fiscal year ending on December 31, and our common stock is listed on the NYSE American under the symbol “IGC.” Please refer to Note 1, “Nature of Operations” and Item 8 of this Transition Report on Form 10-KT, for further information on business segments.

Change of Fiscal Year

In December 2025, our Board of Directors (the “Board”) approved a change in the fiscal year end of the Company from March 31 to December 31. As a result of this change, we are filing this Transition Report on Form 10-KT for the nine-month transition period ended December 31, 2025. The change in fiscal year ends on a prospective basis and does not adjust operating results for prior periods. References to our previous fiscal years mean the fiscal years ending on March 31. The Company’s fiscal year 2026 commenced on January 1, 2026. References herein to “Transition Period” refer to the nine-month period ended December 31, 2025. 

Lead Product Candidate – IGC-AD1

IGC-AD1 is the Company’s lead investigational pharmaceutical product candidate and is currently being evaluated in a Phase 2 clinical trial for the treatment of agitation in patients with Alzheimer’s dementia. Agitation is a common and burdensome neuropsychiatric symptom of Alzheimer’s disease, characterized by behavioral disturbances such as restlessness, irritability, verbal aggression, and physical aggression, and is associated with accelerated disease progression, increased institutionalization, and significant caregiver burden.

The Company is primarily focused on advancing IGC-AD1 through clinical development for agitation in Alzheimer’s dementia. In parallel, based on preclinical findings, the Company is evaluating the potential of IGC-AD1 to impact biological pathways associated with Alzheimer’s disease pathology, which may support future development beyond symptom management.

Mechanism of Action and Therapeutic Rationale

IGC-AD1 is designed to modulate neural signaling pathways implicated in neuropsychiatric symptoms associated with Alzheimer’s disease, including dysregulation of neurotransmission and neuroinflammatory processes. Preclinical studies have demonstrated that the active pharmaceutical ingredient (“API”) in IGC-AD1 interacts with multiple targets relevant to agitation and sleep disturbances, as well as molecular pathways associated with amyloid and tau pathology.

In addition to its neuropsychiatric effects, preclinical models have shown that IGC-AD1 exhibits activity against beta-amyloid aggregation, tau phosphorylation, and mitochondrial dysfunction, suggesting potential disease-modifying properties. These findings support the Company’s ongoing evaluation of IGC-AD1 beyond symptomatic treatment, although no conclusions can be drawn at this stage regarding disease modification in humans.

Clinical Development Program

Phase 1 Clinical Trial

The Company completed a Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics of IGC-AD1 in human subjects. The Phase 1 study demonstrated that IGC-AD1 was generally well tolerated across evaluated dose levels, with no treatment-related serious adverse events reported. These results supported continued advancement of clinical evaluation.

CALMA Trial – Agitation in Alzheimer’s Dementia

The Company’s ongoing Phase 2 clinical trial, referred to as CALMA (“Calming Agitation in Alzheimer’s”), is a multi-site, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of IGC-AD1 in reducing agitation in patients with Alzheimer’s dementia.

CALMA is being conducted at multiple clinical sites in the United States and Canada. As of the date of this report, approximately two-thirds of the targeted enrollment have been completed. The study includes a twice daily (“BID”) dosing regime and evaluates agitation using validated clinical assessment tools, including Cohen’s Mansfield Agitation Inventory (“CMAI”).

Interim Clinical Observations

Previously disclosed interim analyses on the first 26 patients (n=26) from the CALMA trial indicated that patients receiving IGC-AD1 experienced reductions in agitation compared to placebo, with clinical improvements observed as early as two weeks of treatment and sustained through later assessment periods. Additional interim observations indicated improvements in sleep-related disturbances, an exploratory endpoint, suggesting broader neuropsychiatric effects.

These interim findings are preliminary and subject to further analysis upon completion of the trial. Final conclusions regarding safety and efficacy will depend on full dataset evaluation.

Safety and Toxicology

During the period ended December 31, 2025, the Company completed a genetic toxicology study evaluating the mutagenic potential of the API used in IGC-AD1. The results of this study did not identify genotoxic risk under the tested conditions. These findings support the continued clinical development of IGC-AD1 and are consistent with prior nonclinical safety observations.

Regulatory Status

IGC-AD1 is an investigational drug candidate and has not been approved for commercial use by the U.S. Food and Drug Administration (“FDA”) or any other regulatory authority. The Company continues to engage with regulatory agencies as appropriate in connection with its clinical development program. Any future regulatory designations or approvals are subject to regulatory review and cannot be assured.

Clinical Development Strategy

The Company’s clinical development strategy is focused on advancing IGC-AD1 through controlled clinical evaluation for the treatment of agitation in patients with Alzheimer’s dementia. Agitation represents a significant unmet medical need with limited approved therapeutic options and is associated with substantial clinical, caregiver, and healthcare system burden.

The Company has prioritized agitation as an initial indication based on (i) the high prevalence of agitation in Alzheimer’s patients, (ii) the feasibility of measuring clinically meaningful outcomes using validated assessment tools, and (iii) the potential for earlier demonstration of therapeutic benefit compared to cognitive endpoints. While preclinical findings suggest broader biological activity relevant to Alzheimer’s disease pathology, the Company’s near-term clinical focus remains on symptom management.

CALMA Trial Design

The CALMA trial is a multi-site, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety and efficacy of IGC-AD1 in patients with agitation associated with Alzheimer’s dementia.

Key elements of the trial design include:

The trial is being conducted across multiple clinical sites in the United States and Canada. During the nine-month period ended December 31, 2025, the Company expanded its clinical site network to support enrollment and data collection. As of the date of this report, approximately two-thirds of the planned patient enrolment have been completed.

Clinical Endpoints and Assessments

The primary endpoint of the CALMA trial is the change from baseline in agitation as measured by validated components of the CMAI. Exploratory endpoints include additional neuropsychiatric domains and caregiver distress measures as well as blood-based biomarkers.

Sleep disturbance is a common comorbidity in Alzheimer’s dementia and was included as an exploratory endpoint to assess potential broader neuropsychiatric effects of IGC-AD1. Interim observations indicate improvements in sleep-related measures as measured by the Neuropsychiatric inventory (“NPI”) sleep sub-domain; however, these findings are based on interim data and exploratory in nature and will require confirmation upon completion of the full trial dataset.

Interim Analyses and Data Integrity

The Company has conducted pre-specified interim analyses on agitation in accordance with the trial protocol. These analyses were intended to assess safety, tolerability, and preliminary signals of efficacy and were not designed to support definitive conclusions.

Final analysis of the CALMA trial will be conducted following completion of patient enrolment, treatment, and data lock. All statistical analyses will be performed in accordance with the pre-specified statistical analysis plan.

Regulatory Framework

IGC-AD1 is regulated as an investigational pharmaceutical product under applicable FDA and international regulatory requirements. The clinical development, manufacturing, and testing of IGC-AD1 are subject to extensive regulation governing investigational new drugs, including requirements related to safety reporting, clinical trial conduct, manufacturing controls, and data integrity.

The Company is conducting CALMA under an active Investigational New Drug (“IND”) application and is subject to ongoing regulatory oversight in U.S., Canada and other countries where CALMA may be conducted.

Nonclinical Safety and Toxicology

In support of its clinical development program, the Company continues to conduct and has conducted nonclinical safety studies, including genetic toxicology testing. During the nine-month transition period ended December 31, 2025, the Company completed a genetic toxicology study evaluating the mutagenic potential of the API used in IGC-AD1. The study did not identify genotoxic risk under the tested conditions.

These nonclinical data support continued clinical evaluation of IGC-AD1; however, additional toxicology studies, such as an ongoing 90-day rodent study, among others, may be required to support longer-term dosing, expanded indications, or later-stage larger clinical trials.

Regulatory Interactions and Future Development

The Company expects to continue engaging with regulatory authorities as its clinical development program progresses. Any future regulatory submissions, including potential requests for expedited development pathways or expanded indications, are subject to regulatory review and approval and cannot be assured.

The timing, scope, and outcome of future regulatory interactions will depend on clinical trial results, safety data, manufacturing readiness, and regulatory guidance. The Company may adjust its development strategy based on emerging data and regulatory feedback.

Commercialization Considerations

IGC-AD1 has not been approved for commercial sale in any jurisdiction. If approved, commercialization would require additional regulatory approvals, manufacturing scale-up, distribution arrangements, and post-marketing surveillance. The Company has not yet established commercial manufacturing or sales infrastructure for IGC-AD1 and may pursue partnerships or other strategic arrangements to support commercialization.

Existing Treatments for Agitation in Alzheimer’s Dementia

In May 2023, the FDA approved the first medication for the treatment of Agitation associated with Alzheimer’s disease Brexpiprazole, an atypical antipsychotic, with a boxed warning. This approval followed a significantly larger 12-week Phase 3 trial, which showed a CMAI LS mean difference from baseline at week 12, between active treatment and placebo of -5.32 with a Cohen’s d effect size of 0.35, and a p-value of 0.003 (Lee et al., 2023).

MINT-AD – Artificial Intelligence Platform

Overview

The Company is developing a proprietary Multimodal Interpretable Transformer for Alzheimer’s Disease (“MINT-AD”). MINT-AD is an artificial intelligence (“AI”) platform designed to enhance the detection and management of Alzheimer’s disease (“AD”) by providing clinicians with scalable, interpretable, and predictive diagnostic support. The platform is engineered to transition AD diagnostics from specialized, high-cost environments—such as neurology clinics utilizing Positron Emission Tomography (“PET”) scans—to primary care settings, rural areas, and underserved populations.

The Market Opportunity and Diagnostic Gap

According to the World Alzheimer Report, an estimated 400 million individuals globally may carry AD-related pathology prior to the onset of clinical symptoms. Currently, a significant “diagnostic gap” exists due to a lack of accessible early-detection tools for primary care physicians. This gap leads to delayed diagnoses, reduced eligibility for clinical trials, and sub-optimal patient outcomes. MINT-AD is intended to bridge this gap by offering a cost-effective, non-invasive alternative for early cognitive risk assessment.

Proprietary Technology and Architecture

MINT-AD leverages a “Transformer” architecture—a state-of-the-art deep learning model—to harmonize and analyze diverse, multimodal datasets. The platform processes a wide array of data sources to produce clinically actionable insights, including:

Competitive Advantage: Explainable AI (“XAI”) and Regulatory Alignment

A core component of MINT-AD is its “interpretability.” Unlike “black box” AI models that provide outputs without clinical context, MINT-AD utilizes “attention mechanisms” to identify and highlight the specific data points—such as regional brain atrophy or genetic markers—that drive its risk assessments.

Management believes this interpretability provides a significant competitive advantage in two key areas:

Use of MINT-AD

The Company is positioning MINT-AD as a practical, AI-driven assistant for healthcare providers. The platform is designed to support the clinical workflow through three primary objectives:

Agentic Harmonization Assistant (“AHA”)

In support of MINT-AD and the Company’s broader AI research and development efforts, IGC Pharma has and is developing AHA, an agentic analytics and data harmonization architecture designed to support large-scale Alzheimer’s disease research.

AHA is intended to function as a research-layer framework that enables the ingestion, normalization, and analysis of heterogeneous datasets across clinical, imaging, genetic, and behavioral domains. The agentic system will support internal workflows related to dataset harmonization, exploratory analysis, model training, and hypothesis generation. AHA is not intended for clinical use. Instead, it is intended to serve as a research infrastructure that enhances the Company’s ability to develop, validate, and refine AI-driven tools such as MINT-AD and to support data-driven decision-making across the Company’s therapeutic programs.

In 2025, AHA was selected as a semi-finalist in the Alzheimer’s Disease Data Initiative (“ADDI”) USD $1 million Prize competition, a global initiative recognizing innovative approaches to advancing Alzheimer’s disease research and care. The recognition reflects external validation of the technical approach underlying the Company’s analytics and data harmonization capabilities.

Other Product Candidates

In addition to IGC-AD1, the Company maintains a portfolio of earlier-stage therapeutic programs targeting neurodegenerative and neurological disorders. These programs are in preclinical or discovery stages and are subject to significant development risk.

TGR-63

TGR-63 is a preclinical compound under investigation for its potential effects on amyloid plaque formation, a hallmark of Alzheimer’s disease pathology. Preclinical studies have demonstrated reductions in amyloid burden in laboratory models. The Company continues to evaluate TGR-63 to determine its suitability for further development, including potential in vivo studies. TGR-63 has not entered clinical testing, and there can be no assurance that it will advance to human trials.

IGC-M3

IGC-M3 is an investigational small-molecule compound designed as a multifunctional modulator targeting multiple biological processes associated with Alzheimer’s disease. In vitro studies, IGC-M3 has demonstrated activity related to β-amyloid aggregation, oxidative stress, mitochondrial function, and neuroinflammatory signaling. IGC-M3 remains in early preclinical development. The Company plans to conduct additional in vivo studies to further evaluate safety, pharmacology, and potential efficacy before determining whether to advance the compound toward clinical development, although there can be no assurance thereof.

Intellectual Property

IGC Pharma’s intellectual property (“IP”) strategy is focused on building and maintaining a diversified portfolio of issued patents and pending applications that protect its therapeutic candidates, formulations, methods of use, and supporting technologies.

Patent Portfolio

As of the date of this report, the Company’s intellectual property portfolio includes 14 granted patents and 31 pending patent applications worldwide, as summarized in Table 1, covering multiple aspects of its drug development programs, including:

The Company actively evaluates opportunities to expand and strengthen its IP estate through new filings as its programs progress and additional data are generated.

IGC-AD1 Intellectual Property

The Company’s lead candidate, IGC-AD1, is supported by a portfolio of 4 granted patents and twelve (12) patent applications directed to its formulation, dosing approaches, and therapeutic use in Alzheimer’s disease related neuropsychiatric symptoms. These protections are intended to provide commercial exclusivity and support future partnering or licensing discussions, subject to regulatory approval.

Other Product Candidates and Platforms

IGC Pharma’s IP strategy also extends to earlier-stage programs, including preclinical therapeutic candidates and internal data-driven platforms. While some of these assets remain in exploratory or development stages, the Company seeks to protect novel discoveries where appropriate and economically justified. The Company is also always exploring the possibility of forming alliances with other institutions to develop innovations aligned with IGC Pharma’s core business. This includes obtaining license agreements that could benefit the company’s projects.

IP Risk Considerations

The Company’s ability to maintain and enforce its intellectual property depends on timely filings, prosecution outcomes, third-party challenges, and compliance with jurisdiction-specific patent laws. While IGC Pharma believes its intellectual property provides meaningful protection for its development programs, there can be no assurance that issued patents will not be challenged, invalidated, or circumvented, or that pending applications will result in issued patents, or that competitors will not develop alternative approaches.

Table 1 below provides the status of our patent filings:

Table 1: Patent Filings & Status

Patent Protection and Term

Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), certain patents covering approved pharmaceutical products may be eligible for patent term extension to compensate for regulatory review periods. If applicable, a patent term extension may be granted for up to five years, subject to statutory limitations, including a maximum remaining patent term of 14 years from the date of FDA approval.

While the Company may seek patent term extensions for eligible patents in the future, there can be no assurance that any such extensions will be granted, that the length of any extension will be sufficient to provide meaningful additional exclusivity, or that regulatory approval of any product candidate will occur.

Core Business Competencies and Competitive Advantages

We believe our core competencies and competitive advantages include:

We believe these capabilities position us to efficiently advance our clinical programs, expand our pipeline, and pursue potential strategic collaborations. However, there can be no assurance that our competencies will result in regulatory approval, commercial success, or competitive advantage.

Regulatory Strategy and Environment 

IGC Pharma’s regulatory strategy is designed to advance its clinical and preclinical programs in a disciplined, risk-managed manner consistent with U.S. FDA requirements for central nervous system (“CNS”) therapeutics.

Clinical Development and Regulatory Oversight

The Company’s lead clinical candidate, IGC-AD1, is being evaluated under an active Investigational New Drug (“IND”) application with the FDA. The ongoing CALMA clinical trial is designed to assess the safety and efficacy of IGC-AD1 for the treatment of agitation associated with Alzheimer’s disease. The trial is being conducted in accordance with Good Clinical Practice (“GCP”) guidelines and applicable regulatory requirements. IGC Pharma works closely with clinical investigators, contract research organizations (“CROs”), and regulatory consultants to ensure protocol adherence, data integrity, and patient safety. As of the date of this report, approximately two thirds of the target enrollment for the CALMA trial have been completed.

Regulatory Pathway and Future Interactions

The Company’s regulatory strategy emphasizes early and ongoing engagement with the FDA to align clinical trial design, endpoints, and safety requirements with regulatory expectations. While IGC Pharma has evaluated potential opportunities for expedited regulatory pathways, including Fast Track designation, no determinations have yet been made by the FDA, and there can be no assurance that any such designation will be granted. In parallel, the Company continues to advance required nonclinical studies, including genetic toxicology and long-term safety evaluations, to support potential future clinical development and regulatory submissions.

Global Considerations

Although current clinical activities are focused primarily in the United States and Canada, IGC Pharma monitors evolving international regulatory frameworks and has evaluated additional jurisdictions, such as Colombia, South America. We have received permission from the Colombian regulator to conduct the trial in Colombia.

Evolving hemp regulations

Controlled Substances and Hemp Regulatory Considerations

IGC-AD1 is currently manufactured using hemp-derived materials that comply with applicable federal requirements, including those established under the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”). The investigational product contains tetrahydrocannabinol (“THC”) at concentrations consistent with federally permissible thresholds applicable to hemp-derived materials.

The Company previously sourced hemp under state-issued licenses and has evaluated multiple sourcing and manufacturing approaches. Manufacturing pharmaceutical-grade formulations from hemp-derived inputs can be operationally inefficient and subject to evolving regulatory interpretation, particularly as federal and state authorities continue to refine oversight of hemp-derived products.

Recent regulatory developments, including updated federal and state hemp rules and ongoing federal review of cannabis scheduling under the Controlled Substances Act, may affect the regulatory landscape applicable to cannabinoid-based pharmaceutical development. Certain regulatory frameworks may distinguish between consumer hemp products and pharmaceutical products developed under an FDA IND application; however, no assurance can be given regarding the interpretation, implementation, or impact of any such distinctions.

IGC Pharma does not rely on any anticipated regulatory changes in the development of IGC-AD1 and continues to operate its programs in compliance with existing FDA, DEA, and other applicable regulatory requirements.

Contract Research Organization (“CRO”) Strategy and Clinical Trial Infrastructure

IGC Pharma conducts its clinical development activities through a combination of internal clinical operations and selective use of third-party service providers. As part of this approach, the Company has developed internal data management and clinical operations capabilities to support its ongoing and planned clinical trials, including its CALMA trial for IGC-AD1.

The Company utilizes a proprietary electronic data capture (“EDC”) system designed to securely collect, store, and manage clinical trial data in compliance with applicable regulatory requirements and industry standards. The EDC system supports the organization of source documentation and trial data, including patient medical histories, concomitant medications, laboratory results, neuropsychiatric scale assessments, adverse events, safety monitoring data, and demographic information. The system also enables internal data review, reporting, and analysis to support clinical trial oversight and regulatory submissions.

Clinical trials are often associated with significant costs, particularly those related to outsourcing clinical operations to full-service contract research organizations (“CROs”). To improve operational efficiency and cost control, IGC Pharma has elected to internalize certain clinical operations and data management functions while continuing to engage external CROs, vendors, and clinical sites as appropriate. The Company believes this hybrid approach may provide greater flexibility, operational visibility, and cost discipline compared to a fully outsourced model; however, there can be no assurance that such efficiencies will be realized.

IGC Pharma’s clinical development activities remain subject to applicable regulatory requirements, and the Company continues to evaluate its operational structure as its development programs progress.

Products and Services – Life Sciences Segment

Our Life Sciences segment is primarily focused on the research and development of pharmaceutical candidates for neurological and neuropsychiatric conditions, including Alzheimer’s disease. Drug development involves substantial risk, including the requirement for extensive preclinical studies, multi-year clinical trials, significant capital investment, and regulatory approval by the FDA and comparable foreign authorities. There can be no assurance that any of our product candidates will receive regulatory approval or achieve commercial success.

Our lead investigational candidate, IGC-AD1, is currently being evaluated in the CALMA trial for the treatment of agitation associated with Alzheimer’s disease. In addition to IGC-AD1, we are advancing other early-stage assets and research programs intended to expand our pipeline, subject to available capital and regulatory considerations.

We expect that continued investment in clinical trials, research and development, regulatory activities, intellectual property protection, and supporting infrastructure will be required to advance our product candidates. While we may also pursue strategic collaborations, licensing arrangements, or acquisitions to complement our internal development efforts, there can be no assurance that such transactions will occur on acceptable terms, if at all.

Separately, the Life Sciences segment includes limited revenue-generating activities from the sale of customized over-the-counter formulations and other products. In the nine months ended December 31, 2025, the Company divested its Vancouver, Washington, manufacturing facility and no longer operates that facility. These activities are not currently a material focus of our long-term pharmaceutical development strategy.

Markets and Distribution

As a clinical-stage pharmaceutical company, we do not currently have any FDA-approved drug products for commercial sale. Accordingly, our primary activities during the nine months ended December 31, 2025, were focused on clinical development, including the ongoing CALMA trial for IGC-AD1 and the advancement of our research pipeline.

Following the divesture of the Vancouver, Washington facility, the Company no longer maintains in-house manufacturing or over-the-counter product distribution operations. Any future commercialization of approved pharmaceutical products would be expected to rely on third-party manufacturers, strategic partners, or other arrangements typical of clinical-stage biotechnology companies.

Our Life sciences revenue during the nine months ended December 31, 2025, was limited and subject to customer concentration risk. One customer individually accounted for more than 50% of the total revenue. The loss of one or more significant customers, or changes in purchasing behavior, could materially affect our revenue.

Our future participation in the Life Sciences and pharmaceutical markets will depend on the successful development, regulatory approval, and commercialization of our product candidates, as well as our ability to secure adequate financing.

Competition

Industry Overview

The pharmaceutical and biotechnology industries are highly competitive, rapidly evolving, and characterized by significant technological change, regulatory complexity, and substantial capital requirements. The central nervous system (“CNS”) therapeutic area, including Alzheimer’s disease and related neuropsychiatric conditions, is particularly competitive due to the large patient population, high unmet medical need, and potential commercial opportunity.

Our competitors include large multinational pharmaceutical companies, emerging biotechnology companies, and other organizations with significantly greater financial resources, technical capabilities, and experience in clinical development, regulatory approval, manufacturing, and commercialization. Many of these competitors may be able to initiate and complete clinical trials more rapidly, obtain regulatory approvals sooner, or commercialize products more effectively than we can.

Competition in Agitation Associated with Alzheimer’s Disease

Agitation associated with Alzheimer’s disease (“AAD”) is an area of increasing clinical focus. We are aware of several companies developing therapies for this indication, including Axsome Therapeutics, Inc., which is developing a combination of dextromethorphan and bupropion, and Otsuka Pharmaceutical Co., Ltd. and Lundbeck A/S, which received FDA approval for Brexpiprazole (Rexulti) for the treatment of agitation associated with Alzheimer’s disease.

Currently, Brexpiprazole is the only FDA-approved therapy specifically indicated for agitation associated with Alzheimer’s dementia. Other treatment approaches may include off-label use of antipsychotics, antidepressants, or sedatives, many of which carry safety concerns, including boxed warnings.

Differentiation Considerations

Interim data from our ongoing CALMA clinical trial evaluating IGC-AD1 for agitation associated with Alzheimer’s disease have demonstrated a statistically significant improvement in agitation symptoms compared to placebo over a six-week treatment period, as measured by the Cohen-Mansfield Agitation Inventory (“CMAI”). The interim analysis on the first 26 patients indicated a large effect size (Cohen’s d = 0.79) and improvement observed as early as Week 2 of treatment.

For context, published data for Brexpiprazole reported a moderate effect size (Cohen’s d = 0.4) with separation from placebo observed later in the treatment period, based on substantially larger clinical trials. Cross-trial comparisons should be interpreted with caution, as differences in study design, patient populations, endpoints, and duration may materially affect outcomes.

In addition to efficacy, IGC-AD1 has demonstrated a favorable safety profile to date. As of the interim analysis:

The CALMA trial remains ongoing to further evaluate efficacy, durability of response, and long-term safety. There can be no assurance that interim results will be replicated in the final analysis or that IGC-AD1 will receive regulatory approval.

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. Most of our data, including our accounting data, is stored in the cloud, which helps us mitigate the overall risk of losing data. We have a cybersecurity policy in place and are in the process of implementing tighter cybersecurity measures to safeguard against hackers. The Company holds all rights to the patents that have been filed by us with the USPTO.

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 the nine months ended December 31, 2025:

Governmental Regulations

Our operations are subject to extensive regulation and oversight by U.S. federal, state, and local governmental authorities. These regulations govern, among other matters, pharmaceutical research and development, clinical trials, manufacturing practices, marketing, intellectual property, and securities law compliance.

Pharmaceutical Regulation

The development, testing, manufacturing, and commercialization of our investigational drug candidates, including IGC-AD1, are subject to regulation by the FDA and comparable foreign regulatory authorities. Our clinical development activities are conducted under an IND application and are subject to FDA requirements governing clinical trial conduct, data integrity, safety reporting, and manufacturing standards.

Any future commercialization of our drug candidates will require FDA approval, and there can be no assurance that such approval will be obtained.

Cannabis and Hemp Regulatory Framework

Certain of our investigational formulations incorporate cannabinoids that are derived from hemp. Under the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), hemp is defined as cannabis containing no more than 0.3% THC on a dry-weight basis and is federally legal in the United States.

Although hemp is federally legal, states retain authority to regulate the cultivation, processing, testing, and handling of hemp and hemp-derived materials. As a result, state laws and regulatory requirements vary and continue to evolve. Compliance may require obtaining licenses, registrations, and approvals at the state level, and failure to comply could result in enforcement actions, penalties, or limitations on operations.

Historically, the Company cultivated hemp under applicable state licenses, including in Arizona. The Company no longer operates cultivation facilities and does not currently engage in hemp farming activities.

Distinction from Consumer Hemp Products

Importantly, IGC-AD1 is being developed as a pharmaceutical product under FDA oversight, and not as a consumer hemp or wellness product. As such, it is subject to the regulatory framework applicable to investigational drugs rather than consumer cannabinoid products sold under the 2018 Farm Bill.

Recent and proposed changes to hemp and cannabis regulations, including restrictions on total THC content in consumer products and evolving federal policy regarding cannabis scheduling, may further differentiate FDA-regulated pharmaceutical products from non-pharmaceutical cannabinoid products. However, the regulatory environment remains uncertain, and future changes in law or enforcement policy could materially affect our business, development timelines, or costs.

Securities and Other Regulatory Oversight

As a public company, we are also subject to regulation by the U.S. Securities and Exchange Commission (“SEC”), the NYSE American, and applicable state securities regulators, as well as laws governing corporate governance, disclosure, and reporting obligations.

FDA Approval Process

In the U.S., pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, or the FDC Act, and other federal and state statutes and regulations, govern the research, development, testing, manufacturing, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring, and reporting, sampling, and importing and exporting of pharmaceutical products, among other things. 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.

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. For commercial approval, the sponsor must submit adequate tests by all methods reasonably applicable to show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling. The sponsor must also submit substantial evidence, generally consisting of adequate, well-controlled clinical trials, to establish that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling. 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.

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. Department of Agriculture’s (“USDA”) 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. Long-term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

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 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. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with Good Clinical Practice (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors; and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.

The FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board, or IRB, for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or may impose other conditions.

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In general, in Phase 1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance, and optimum dosage and to identify common adverse effects and safety risks. 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. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. The FDA may, however, determine that a drug is effective based on one clinical study plus confirmatory evidence. Only a small percentage of investigational drugs complete all three phases and obtain marketing approval. 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.

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. The NDA must include the results of all pre-clinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls. The cost of preparing and submitting an NDA is substantial.

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. Under the statute and implementing regulations, the FDA has 180 days (the initial review cycle) from the date of filing to issue either an approval letter or a complete response letter unless the review period is adjusted by mutual agreement between the FDA and the applicant or as a result of the applicant submitting a major amendment. In practice, the performance goals established pursuant to the Prescription Drug User Fee Act have effectively extended the initial review cycle beyond 180 days. The FDA’s current performance goals call for the FDA to complete a review of 90 percent of standard (non-priority) NDAs within 10 months of receipt and within six months for priority NDAs, but two additional months are added to standard and priority NDAs for a new molecular entity (“NME”).

The FDA 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 is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with the current GMP is satisfactory, and the NDA contains data that provides substantial evidence that the drug is safe and effective in the indication studied.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing 90 percent of resubmissions within two to six months, depending on the type of information included.

An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. 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). ETASU can include, but is not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or if problems are identified following initial marketing.

Expedited Development:

Designations such as Breakthrough Therapy Designation (“BTD”) and Fast Track Designation can speed up the development process by allowing for more frequent communication with the FDA and potentially faster review timelines. This can translate to getting the drug to market quicker.

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. Information related to the product, patient population, phase of the investigation, study sites, investigator, and other aspects of the clinical trial is made public as part of the registration. Disclosure of the results of these trials can be delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file an application for approval of a new indication for an approved product within one year. 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. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. 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”). An ANDA provides for the marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown through bioequivalence testing to be bioequivalent to the listed drug. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct or submit results of pre-clinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in this way are considered to be therapeutically equivalent to the listed drug, are commonly referred to as “generic equivalents” to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug in accordance with state law.

The ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired but will expire on a particular date, and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The ANDA applicant may also elect to submit a section viii statement, certifying that its proposed ANDA labeling does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. 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. If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant. The ANDA application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the referenced product has expired.

Exclusivity

Upon NDA approval of a new chemical entity or NCE, which is a drug that contains no active component that has been approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity, during which time the FDA cannot receive any ANDA or 505(b)(2) application seeking approval of a drug that references a version of the NCE drug. Certain changes to a drug, such as the addition of a new indication to the package insert, are associated with a three-year period of exclusivity during which the FDA cannot approve an ANDA or 505(b)(2) application that includes the change. An ANDA or 505(b)(2) application may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed. If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and thus, no ANDA or 505(b)(2) application may be filed before the expiration of the exclusivity period.

For a botanical drug, the FDA may determine that the active moiety is one or more of the principal components or the complex mixture as a whole. This determination would affect the utility of any five-year exclusivity as well as the ability of any potential generic competitor to demonstrate that it is the same drug as the original botanical drug. 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.

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. (or affects more than 200,000 in the U.S. and for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for such disease or condition will be recovered from sales in the U.S. of such drug). Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. If the FDA designates an orphan drug based on a finding of clinical superiority, the FDA must provide a written notification to the sponsor that states the basis for orphan designation, including “any plausible hypothesis” relied upon by the FDA. The FDA must also publish a summary of its clinical superiority findings upon granting orphan drug exclusivity based on clinical superiority. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA application user fee.

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. According to its performance goals, the FDA is supposed to evaluate the protocol within 45 days of the request to assess whether the proposed trial is adequate, and that evaluation may result in discussions and a request for additional information. A SPA request must be made before the proposed trial begins, and all open issues must be resolved before the trial begins. If a written agreement is reached, it will be documented and made part of the administrative record. Under the FDC Act and FDA guidance implementing the statutory requirement, an SPA is generally binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining safety or efficacy after the study begins, public health concerns emerge that were unrecognized at the time of the protocol assessment, the sponsor and the FDA agree to the change in writing, or if the study sponsor fails to follow the protocol that was agreed upon with the FDA.

U.S. Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of our lead product candidates, such as IGC-AD1 or any other for which we may seek regulatory approval. Sales in the U.S. will depend in part on the availability of adequate financial coverage and reimbursement from third-party payors, which include government health programs such as Medicare, Medicaid, TRICARE, and the Veterans Administration, as well as managed care organizations and private health insurers. Prices at which we or our customers seek reimbursement for our product candidates can be subject to challenge, reduction, or denial by payors.

The process for determining whether a payor will provide coverage for a product is typically separate from the process for setting the reimbursement rate that the payor will pay for the product. Third-party payors may limit coverage to specific products on an approved list or formulary, which might not include all the FDA-approved products for a particular indication. Also, third-party payors may refuse to include a branded drug on their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or another alternative is available. Medicare Part D, Medicare’s outpatient prescription drug benefit, contains protections to ensure coverage and reimbursement for oral oncology products, and all Part D prescription drug plans are required to cover substantially all oral anti-cancer agents. However, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be available. Private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations. Sales of products such as IGC-AD1 or any other product candidates will, therefore, depend substantially on the extent to which the costs of our products will be paid by third-party payors. 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. To obtain coverage and reimbursement for any product that might be approved for marketing, we may need to conduct studies in order to demonstrate the medical necessity and cost-effectiveness of any products, which would be in addition to the costs expended to obtain regulatory approvals. 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.

Human Capital Management and Environment, Health, and Safety

Human Capital Management

We believe that our ability to attract, retain, and develop exceptional talent is critical to our success, particularly in advancing our clinical development programs and scientific research. As of December 31, 2025, our full-time employee headcount worldwide was 70.

We foster a culture of collaboration, accountability, and innovation. We comply with all applicable labor, health, and safety laws and support employee well-being through flexible work policies and safe workplace practices. We invest in employee development, offering training and learning opportunities to help our teams grow professionally and contribute to our long-term success. We are committed to providing equal opportunities for all employees. Our compensation and equity programs are designed to retain talent and align with long-term shareholder value.

Environment, Health, and Safety (EHS)

We are committed to health, safety, and environmental compliance in all our operations in the U.S., Colombia, and India. While our operations have a limited environmental impact, we promote responsible practices to minimize waste and ensure safety in our research and office environments. Management oversees our EHS practices and updates them as needed to meet regulatory and operational requirements.

Available Information

The Company’s Transition Report on Form 10-KT, 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”). 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. 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.

ITEM 1A. RISK FACTORS

You should carefully consider the following risk factors, together with all other information included in this report, in evaluating the Company and our common stock. If any of the following risks and uncertainties develop into actual events, they could have a material adverse effect on our business, financial condition, or results of operations. In that case, the trading price of our common stock and other securities also could be adversely affected. We make various statements in this section, which constitute “forward-looking statements.” See “Forward-Looking Statements.”

Risks Related to Our Business, Industry, and Operations:

We have limited revenues, incurred significant losses, and have an accumulated deficit. If we cannot achieve profitability, the market price of our common stock could decline significantly.

As of December 31, 2025, we had cash and cash equivalents of approximately $900 thousand and a working capital deficit of approximately $366 thousand compared to cash and cash equivalents of $405 thousand and working capital of $639 thousand as of March 31, 2025, for continuing operations.

We have had limited revenues. As of the nine months ended December 31, 2025, and 2024, and the twelve months ended March 31, 2025, we had revenues of approximately $869 thousand and $941 thousand, and 1.3 million, respectively.

We have had a history of operating losses. Our net losses improved by approximately $1.9 million from $4.1 million during the nine months ended December 31, 2025, to approximately $6 million during the nine months ended December 31, 2024. We expect to continue incurring substantial expenses as we advance the clinical development of IGC-AD1 and our other product candidates. Our ability to achieve or sustain profitability depends on our success in developing, obtaining regulatory approval for, and commercializing our product candidates, which is highly uncertain and subject to significant risks. If we fail to achieve profitability or improve our financial condition, our ability to raise additional capital may be limited, and the market price of our common stock could decline significantly. Additionally, continued losses could impact our ability to maintain compliance with applicable stock exchange listing requirements.

We may be unable to complete financings on acceptable terms, certain financings are subject to required approvals, and we have sought and may continue to seek financing from our officers and directors.

We have historically funded operations primarily through issuances of equity and other financing transactions. Our ability to raise additional capital depends on market conditions, investor demand, and other factors beyond our control. Certain transactions may be subject to approvals and conditions, including applicable stock exchange approval. If we are unable to obtain required approvals, satisfy closing conditions, or raise capital when needed, we may be required to delay, reduce, or discontinue research and development programs, including clinical activities, or pursue alternatives that may be highly dilutive or otherwise unfavorable to stockholders.

In addition, we have sought and may continue to seek financing, primarily through the issuance of equity securities for cash and loans from our officers and directors, to operate our business and estimates that additional capital will be necessary to support our operations and growth. As of December 31, 2025, we are indebted to Ms. Claudia Grimaldi, our vice president, principal financial officer, chief compliance officer, and director, by way of a loan of $146 thousand. We may not be able to generate sufficient cash flow to repay this loan. If we issue additional securities as repayment, our shareholders may experience significant dilution. Additionally, loan repayment before achievement of profitability may cause us to delay implementing our business plans to expand.

We Depend on a Limited Number of Customers for a Significant Portion of Our Life Sciences Revenue.

During the nine months ended December 31, 2025, approximately 58% of our Life Sciences revenue was derived from a single customer. Although our primary business focus is the development and clinical advancement of our therapeutic candidates, revenue generated from our Life Sciences operations contributes to offsetting certain operating expenses and overhead.

Our revenue concentration increases our exposure to risks associated with changes in the financial condition, purchasing patterns, or strategic priorities of this customer. The loss of this customer, a reduction in purchases, changes in pricing, delays in payments, or an inability to renew or replace such revenue on comparable terms could adversely affect our results of operations and increase our operating cash requirements. In addition, reliance on a limited number of customers may reduce our negotiating leverage and expose us to counterparty credit risk.

We may not be able to diversify our customer base in a timely manner or at all. Any material disruption in revenue from significant customers could have an adverse effect on our financial condition and operating results.

Our classification as a “cannabis company” creates institutional barriers to capital that may require us to utilize higher-cost alternative financing.

While our lead candidate, IGC-AD1, is derived from legal hemp—defined under the 2018 Farm Bill as Cannabis sativa L. with a THC concentration of 0.3% or less—the Company is frequently and incorrectly classified by financial institutions as a “cannabis company.” This mischaracterization has historically led to being blacklisted by certain banks, investment firms, and stock clearing services.

The limited number of institutions willing to service companies with cannabinoid-based portfolios makes it more difficult to raise capital, deposit share certificates, or establish traditional investment banking relationships on standard terms. Consequently, to fund operations or bridge clinical milestones, management may, at its discretion, utilize alternative financing arrangements.

These alternative options may include high-cost loans or convertible notes with effective interest rates that are significantly higher than traditional bank rates. While the Company intends to use such arrangements judiciously and for relatively small amounts, they can involve significant debt service obligations, cross-default provisions, or variable conversion features. If we are forced to rely on these more expensive capital sources because of industry stigma, it could lead to share dilution, higher cash outflows, or an impaired balance sheet. There can be no assurance that we will be able to raise sufficient capital on favorable terms if institutional hurdles regarding our industry classification persist.

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.

From time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases, and out-licensing or in-licensing of products, product candidates, or technologies, particularly those arrangements that seek to leverage other organizations’ internal platforms or competencies for the benefit of our products or potential products. Additional potential transactions that we may consider may include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations, and investments. Any such transaction may require us to incur non-recurring or other charges that may increase our near and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results. For example, these transactions may entail numerous operational and financial risks, including:

There can be no assurance that we will undertake or successfully complete any transactions of the nature described above. Any transactions that we do complete could have a material adverse effect on our business, results of operations, financial condition, and prospects if we are unable to execute the planned objectives or capitalize on the relationship in the manner that was originally contemplated.

Global Operations

We currently operate in the U.S., Canada, Colombia, and India, and buy raw materials and equipment from China, and our operations and expenses could be affected by currency fluctuations, capital and exchange controls, economic conditions including inflation, expropriation, and other restrictive government actions, changes in intellectual property legal protections and remedies, trade regulations, tax laws, and regulations, and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including but not limited to the current conflicts, terrorist activity, unstable governments, and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.

India, and Colombia may be particularly vulnerable to periods of financial or political instability or significant currency fluctuations or may have limited resources for healthcare spending.

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, especially with China and the countries we operate in, and potential trade conflicts and impediments that could impact our business. If trade restrictions or tariffs reduce global economic activity, potential impacts could include declining sales, increased costs, volatility in foreign exchange rates, a decline in the value of our financial assets and pension plan investments, required increases of our pension funding obligations, increased government cost control efforts, delays or failures in the performance of customers, suppliers and other third parties on whom we may depend for the performance of our business, and the risk that our allowance for doubtful accounts may not be adequate.

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. 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, and Colombia, relating to the protection of the public and necessary disclosures regarding financial services. Liability under these laws involves inherent uncertainties. Violations of financial regulation laws are subject to civil and, in some cases, criminal sanctions. We may not have been, or may not be, or may be alleged to have not been or to not be, at all times, in complete compliance with all requirements, and we may incur costs or liabilities in connection with such requirements or allegations. We may also incur unexpected interruptions to our operations, administrative injunctions requiring operation stoppages, fines judgments, settlements, or other financial obligations or penalties, which could negatively impact our financial condition and results of operations. See Item 3, Legal Proceedings of this report, for further information on the current status of legal proceedings, if any. There can also be no assurance that any insurance coverage we have will be adequate or that we will prevail in any future cases. We can provide no assurance that we will be able to obtain liability insurance that would protect us from any such lawsuits. 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.

Our Company is in a highly regulated industry. Significant and unforeseen changes in policy may have material impacts on our business.

Continued development in the phytocannabinoids industry is dependent upon continued state legislative authorization of cannabinoids as well as legislation and regulatory policy at the federal level. The federal Controlled Substances Act currently makes cannabinoids use and possession illegal on a national level. While there may be ample public support for legislative authorization, numerous factors impact the legislative process. 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. It is unclear whether regulatory authorities in the U.S. would object to the registration or public offering of securities in the U.S. by our Company; the status of our Company as a reporting company; or investors investing in our Company, if we engage in legal cannabinoids cultivation and supply pursuant to the laws and authorization of the jurisdiction where the activity takes place. In addition, the status of cannabinoids under the Controlled Substances Act may have an adverse effect on federal agency approval of pharmaceutical use of phytocannabinoid products. Any such objection or interference could delay indefinitely or increase substantially the costs to access the equity capital markets, test our therapies, or create products from the Life Sciences segment.

Our Company is inexperienced in conducting pre-clinical and clinical trials.

Our Company is inexperienced in conducting pre-clinical and clinical trials. Our attempt at demonstrating safety, efficacy, and ultimate useability may fail because of our lack of experience in designing, managing, and conducting clinical trials, resulting in unanticipated or adverse outcomes. Such outcomes may have an adverse effect on our stock price.

Clinical trials are expensive, time-consuming, and difficult to design and implement, and involve an uncertain outcome.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, IGC-AD1 and our other compounds may not have favorable results in later preclinical and clinical studies or receive regulatory approval. We may experience delays in initiating and completing any clinical trials that we intend to conduct, and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time, or be completed on schedule, or at all. Clinical trials can be delayed or terminated for a variety of reasons, including but not limited to:

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. 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. 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.

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 time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate, and it is possible that we will never obtain regulatory approval for IGC-AD1 or any other product candidate. We are not permitted to market any of our pharmaceutical product candidates in the United States until we receive regulatory approval of an NDA from the FDA. The regulatory approval process can be affected by, among other things, the following:

Prior to obtaining approval to commercialize a product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-controlled clinical trials and to the satisfaction of the FDA or foreign regulatory agencies that such product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if the preclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. 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.

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:

Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval processes and are commercialized. This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in us failing to obtain regulatory approval to market IGC-AD1 or another product candidate, which would significantly harm our business, results of operations, and prospects.

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. 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. Further, IGC-AD1 is based on a new approach to treating symptoms of Alzheimer’s Disease, which makes it difficult to predict the time and cost of development and subsequent obtaining of regulatory approval.

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. The only drugs approved by the FDA to treat Alzheimer’s Disease to date address the disease’s symptoms. Alzheimer’s Disease drug candidates have the highest failure rate of approximately 99.6%. As a result, the FDA has a limited set of products to rely on in evaluating IGC-AD1. This could result in a longer-than-expected regulatory review process, increased expected development costs, or the delay or prevention of commercialization of IGC-AD1 for the treatment of Alzheimer’s Disease.

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. We may encounter delays in enrolling or be unable to enroll a sufficient number of patients to complete any of our clinical trials, and even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials. Patient enrollment and retention in clinical trials depend on many factors, including:

Our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval or, if approved, require them to be taken off the market, require them to include safety warnings, or otherwise limit their sales.

Serious adverse events or undesirable side effects caused by IGC-AD1 or any other product candidates could cause us or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. The results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.

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. In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial condition, and prospects significantly.

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:

Any of these events could prevent us from achieving or maintaining market acceptance of a product candidate, if approved, and could significantly harm our business, results of operations, and prospects.

Our product candidates may be unable to achieve the expected market acceptance, consequently limiting our ability to generate revenue from new products.

Even when product development is successful and regulatory approval has been obtained, our ability to generate sufficient revenue depends on the acceptance of our products by customers. We cannot assure you that our products will achieve the expected level of market acceptance and revenue. 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.

The success and acceptance of a product in one state may not be replicated in other states or may be negatively affected by our activities in another state. Any factors preventing or limiting the market acceptance of our products could have a material adverse effect on our business, results of operations, and financial condition.

Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.

Loss of our manufacturing facilities, stored inventory, or laboratory facilities through fire, theft, natural disasters, or other causes, or loss of our botanical raw material due to pathogenic infection, waste, destruction, or other causes, could have an adverse effect on our ability to meet demand for our products or to continue product development activities and to conduct our business. 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.

Climate change may cause extreme weather events that, among other things, could damage our facilities and equipment, injure our employees, disrupt operations at one or more of our primary locations, negatively affect our ability to service and interact with our clients, and adversely affect the value of our assets. Any of these events may increase our costs including our costs to insure against these events.

Climate change may also have a negative impact on the financial condition of our clients, which may decrease revenues from those clients and increase the credit exposures to those clients. Additionally, our reputation and client relationships may be damaged as a result of our involvement, or our clients’ involvement, in certain industries associated with causing or exacerbating, or alleged to cause or exacerbate, climate change. We also may be negatively impacted by any decisions we make to continue to conduct or change our activities in response to considerations relating to climate change. New regulations or guidance relating to climate change, as well as the perspectives of shareholders, employees, and other stakeholders regarding climate change, may affect whether and on what terms and conditions we engage in certain activities or offer certain products.

Currency fluctuations may reduce our assets and profitability.

We have assets located in foreign countries that are valued in foreign currencies. Fluctuation of the U.S. dollar relative to the foreign currency may adversely affect our assets and profit.

Our business relies heavily on our management team, and any unexpected loss of key officers may adversely affect our operations.

The continued success of our business is largely dependent on the continued services of our key employees. The loss of the services of certain key personnel, without adequate replacement, could have an adverse effect on our performance. Our senior management, as well as the senior management of our subsidiaries, plays a significant role in developing and executing the overall business plan, maintaining client relationships, proprietary processes, and technology. While no one is irreplaceable, the loss of the services of any would be disruptive to our business.

Our quarterly revenue, operating results, and profitability will vary.

Factors that may contribute to the variability of quarterly revenue, operating results, or profitability include:

We may not successfully register the provisional patents with the USPTO.

We have filed thirty (30) 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. 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.

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 intend to protect our intellectual property through limited patents and our unpatented trade secrets and know-how through confidentiality or license agreements with third parties, employees, and consultants, and by controlling access to and distribution of our proprietary information. However, this method may not afford complete protection, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the U.S., and unauthorized parties may copy or otherwise obtain and use our products, processes, or technology. Additionally, there can be no assurance that others will not independently develop similar know-how and trade secrets. We are also dependent upon the owners of intellectual property rights licensed to us under various wholesale license agreements to protect and defend those rights against third party claims. If third parties take actions that affect our rights, the value of our intellectual property, similar proprietary rights or reputation, or the licensors who have granted us certain rights under wholesale license agreements, or we are unable to protect the intellectual property from infringement or misappropriation, other companies may be able to offer competitive products at lower prices, and we may not be able to effectively compete against these companies. We also face the risk of claims that we have infringed third parties’ intellectual property rights. Any claims of intellectual property infringement, even those without merit, may require us to:

In the event of claims by third parties for infringement of intellectual property rights, we license from third parties under wholesale license agreements, we could be liable for costs of defending allegations of infringement, and there are no assurances the licensors will either adequately defend the licensed intellectual property rights or that they would prevail in the related litigation. 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.

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. HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions, as well as standards relating to the privacy and security of individually identifiable health information. These obligations would require the Company to adopt administrative, physical, and technical safeguards to protect such information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates” — independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates, and possibly other persons and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thereby complicating compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and criminal penalties.

Some of our lines of business will rely on third-party service providers to host and deliver services and data, and any interruptions or delays in these hosted services, security or privacy breaches, including cybersecurity attacks or failures in data collection, could expose us to liability claims, increased costs, reduced revenue, and harm our business and reputation.

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. We do not have redundancy for all our systems; many of our critical applications reside in only one of our data centers, and our disaster recovery planning may not account for all eventualities. These facts could cause reputational harm, loss of customers, or loss of future business, thereby reducing our revenue.

Our suppliers and distributors and their third-party service providers hold customer data, some of which is hosted in third-party facilities. A security incident or cybersecurity attack at those facilities or ours may compromise the confidentiality, integrity, or availability of customer data. We have a cybersecurity policy in place; however, unauthorized access to customer data stored on our computers or networks may be obtained through break-ins, breaches of our secure network by an unauthorized party, employee theft or misuse, or other misconduct. It is also possible that unauthorized access to customer data may be obtained through inadequate use of security controls by customers. Accounts created with weak passwords could allow cyber-attackers to gain access to customer data. If there were an inadvertent disclosure of customer information, or if a third party were to gain unauthorized access to the information we possess on behalf of our customers, our operations could be disrupted, our reputation could be damaged, and we could be subject to claims or other liabilities. In addition, such perceived or actual unauthorized disclosure of the information we collect, or breach of our security could damage our reputation, result in the loss of customers, and harm our business.

Hardware or software failures or errors in our systems or those of our suppliers and distributors or their third-party service providers could result in data loss or corruption, cause the information that we collect to be incomplete or contain inaccuracies that our customers regard as significant, or cause us to fail to meet committed service levels. Furthermore, our ability to collect and report data may be delayed or interrupted by several factors, including access to the internet, the failure of our network or software systems, or security breaches. In addition, computer viruses or other malware may harm our systems, causing us to lose data, and the transmission of computer viruses or other malware could expose us to litigation. We may also find, on occasion, that we cannot deliver data and reports in near real time because of several factors, including failures of our network or software. If we supply inaccurate information or experience interruptions in our ability to capture, store and supply information in near real time or at all, our reputation could be harmed, we could lose customers, or we could be found liable for damages or incur other losses.

All our data is stored on the cloud on multiple servers, which helps us mitigate the overall risk of losing data. We are in the process of implementing tighter cybersecurity measures to safeguard against hackers. Complying with these security measures and compliances would incur further costs.

The states in which we and our distributors and suppliers and their service providers operate require that we maintain certain information about our customers and transactions. If we fail to maintain such information, we could be in violation of state laws. Laws and regulations relating to the handling of personal data may impede the adoption of our services or result in increased costs, legal claims, fines against us, or reputational damage.

We face risks associated with the manufacture of our products, which could adversely affect our business and financial results.

We are subject to the risks inherent in manufacturing our products, including industrial accidents, environmental events, strikes and other labor disputes, disruptions in supply chain or information systems, loss or impairment of key manufacturing sites or suppliers, product quality control, safety, increase in commodity prices and energy costs, licensing requirements and other regulatory issues, as well as natural disasters and other external factors over which we have no control. If such an event were to occur, it could have an adverse effect on our business and financial results.

Investment in Digital Assets Could Adversely Affect Our Financial Condition and Results of Operations

Management is considering a treasury policy that permits the investment of a limited portion of our available funds in digital assets, such as digital assets and other cryptocurrencies, either directly or through exchange-traded products (“ETPs”) that hold such assets. During the Transition Period, the Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP during the nine months ended December 31, 2025, which was valued at approximately $38 thousand as of December 31, 2025, that provides exposure to digital assets. The Company does not directly hold cryptocurrencies or other digital tokens. Investments in digital assets are subject to significant risks and volatility:

There is no assurance that any investment in digital assets will result in a positive return, and we may incur losses that could adversely affect our business, financial condition, and results of operations.

We may not be successful in our artificial intelligence initiatives, which could adversely affect our business, reputation, or financial results.

We are making investments in AI initiatives, including generative AI, to, among other things, recommend relevant unconnected content across our products, enhance our advertising tools, develop new products, and develop new features for existing products. In particular, we expect our AI initiatives will require increased investment in infrastructure and headcount.

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. 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. It is also uncertain how various laws related to online services, intermediary liability, and other issues will apply to content generated by AI. 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.

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. 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.

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.

Potential Risks Associated with the Disposal of Non-Core Assets

While our current focus is on advancing our Life Sciences business, we continue to own certain non-core assets, including infrastructure-related properties and equipment. We have not made a formal decision to dispose of these assets, other than “Asset held for sale”. Our decision to dispose of these non-core assets is aimed at monetizing non-core assets, streamlining operations, and optimizing resource allocation. However, if we decide to proceed with a sale, divestiture, or shutdown in the future, we may face various risks, including:

Any of these factors could negatively affect our business, financial condition, or results of operations. Investors should be aware of the potential risks associated with this process and its potential impact on our financial performance before investing in our company.

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.

The Company records a write-down for product and component inventories that become obsolete or exceed anticipated demand or for which cost exceeds net realizable value. The Company may also accrue necessary cancellation fee reserves for orders of excess products and components. The Company reviews long-lived assets, including capital assets held at its suppliers’ facilities and inventory prepayments, for impairment whenever events or circumstances indicate the assets may not be recoverable. If the Company determines that an impairment has occurred, it records a write-down equal to the amount by which the carrying value of the asset exceeds its fair value. Although the Company believes its inventory, capital assets, inventory prepayments, and other assets and purchase commitments are currently recoverable, no assurance can be given that the Company will not incur write-downs, fees, impairments, and other charges given the rapid and unpredictable pace of product obsolescence in the industries in which the Company competes.

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. 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.

Given our small size and foreign operations, a small unrectified mistake in the preparation of financial statements and the maintenance of our books and records in accordance with U.S. GAAP and SEC rules and regulations may constitute a material weakness in our internal controls over financial reporting. For more information, please see Item 9A, “Controls and Procedures.”

The Company is subject to complex and changing laws and regulations worldwide related to climate change and ESG initiatives, which expose the Company to potential liabilities, increased costs, and other adverse effects on the Company’s business.

We are subject to transitional and physical risks related to climate change. Transitional risks include, for example, a disorderly global transition away from fossil fuels that may result in increased energy prices; customer preference for low or no-carbon products; stakeholder pressure to decarbonize assets; or new legal or regulatory requirements that result in new or expanded carbon pricing, taxes, restrictions on greenhouse gas emissions, and increased greenhouse gas disclosure and transparency. 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. 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.

Governmental authorities, non-governmental organizations, customers, investors, employees, and other stakeholders are increasingly sensitive to ESG matters, such as equitable access to medicines and vaccines, product quality and safety, diversity, equity and inclusion, environmental stewardship, support for local communities, value chain environmental and social due diligence, corporate governance, and transparency, and addressing human capital factors in our operations. 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. While we strive to improve our ESG performance and meet our voluntary goals, if we do not meet, or are perceived not to meet, our goals or other stakeholder expectations in key ESG areas, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products or other negative impacts on 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.

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.

Our certificate of incorporation authorizes the issuance of up to 600,000,000 shares of common stock, par value of $0.0001 per share, and 1,000,000 shares of preferred stock, par value of $0.0001 per share. We are not restricted from issuing additional shares of our common stock or preferred stock, including any securities that are convertible into or exchangeable for or that represent the right to receive common stock or preferred stock or any substantially similar securities. The market price of our common stock could decline as a result of sales of a large number of shares of our common stock by us in the market or the perception that such sales could occur. If we raise funds by issuing additional securities in the future or stock options to purchase our common stock are exercised, the newly issued shares will also dilute your percentage ownership in our Company.

Our common stock price has fluctuated considerably and has recently reached our highest price levels, which may not be sustained.

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 36-week closing price range being at a low of $0.27 and a high of $0.47 per share. Future announcements concerning the introduction of new products, services, or technologies or changes in product pricing policies by us or our competitors, or changes in earnings estimates by analysts, among other factors, could cause the market price of our common stock to fluctuate substantially. Also, stock markets have experienced extreme price and volume volatility in the last year. This volatility has had a substantial effect on the market prices of securities of many public companies for reasons frequently unrelated to the operating performance of the specific companies. These broad market fluctuations may also cause declines in the market price of 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.

The Market Price of Our Common Stock Has Been and May Continue to Be Volatile.

The market price of our common stock has experienced significant volatility and may continue to fluctuate materially in response to numerous factors, many of which are beyond our control. These factors include, among others:

Because we are a clinical-stage company with limited revenue and ongoing operating losses, our stock price may be more sensitive to market expectations and external developments than the stock prices of more established companies. Significant volatility in the market price of our common stock could result in substantial losses for investors and may adversely affect our ability to access the capital markets.

If We Fail to Maintain Compliance with NYSE American Continued Listing Standards, Our Common Stock Could Be Delisted.

Our common stock is listed on the NYSE American. Continued listing is subject to compliance with various quantitative and qualitative continued listing standards, including minimum bid price and other financial requirements. If we fail to satisfy the NYSE American’s continued listing standards, the exchange may initiate delisting proceedings.

Furthermore, under new NYSE American rules expected to take effect in October 2026, the exchange may immediately commence delisting proceedings if the closing price of our common stock is $0.25 or less on any trading day. If our stock price falls below this threshold, we would not be entitled to the traditional cure periods typically available for other price-based deficiencies, which could result in an immediate and accelerated delisting.

To avoid such a delisting, we may be required to implement a reverse stock split to increase the per-share market price of our common stock. However, there can be no assurance that a reverse stock split, if implemented, will result in a sustained increase in the market price of our common stock or that we will be able to maintain compliance with the minimum price requirements over the long term. A reverse stock split could also be viewed negatively by the market, potentially leading to increased volatility or a further decline in our market capitalization.  A delisting of our common stock could adversely affect the liquidity and market price of our common stock, limit our access to capital markets, reduce analyst coverage, and impair our ability to execute our business strategy.

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 may purchase shares of our common stock to hedge existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders of our common stock. Those repurchases may, in turn, dramatically increase the price of our common stock until investors with short exposure are able to purchase additional shares of common stock to cover their short position. This is often referred to as a “short squeeze.” A short squeeze could lead to volatile price movements in shares of our common stock that are not directly correlated to the performance or prospects of our Company, and once investors purchase the shares necessary to cover their short position, the price of our common stock may decline. We believe that the recent volatility in our common stock may be due, in part, to short squeezes that may be temporarily increasing the price of our common stock, which could result in a loss of some or all of your investment in our common stock.

Our management team will have broad discretion over the use of Company funds.

Our management will use their discretion to direct the use of Company funds. We intend to use the net proceeds from the sale of IGC shares in ATM offerings, sales proceeds, sale of capital assets, and other funds to fund working capital and capital expenditure requirements. It may also be used for clinical trials, share repurchases, debt repayments, and investments, including but not limited to mutual funds, treasury bonds, cryptocurrencies, and other asset classes. Management’s judgments may not result in positive returns on investor investment, and the investor will not have an opportunity to evaluate the economic, financial, or other information upon which the Management bases its decisions. The Company may invest the funds, pending their use, in a manner that does not produce income or that loses value. 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.

Our publicly filed reports are subject to review by the SEC, and any significant changes or amendments required as a result of any such review may result in material liability to us and may have a material adverse impact on the trading price of our common stock.

The reports of publicly traded companies are subject to review by the SEC from time to time for the purpose of assisting companies in complying with applicable disclosure requirements, and the SEC is required to undertake a comprehensive review of a company’s reports at least once every three years under the Sarbanes-Oxley Act of 2002. SEC reviews may be initiated at any time. We could be required to modify, amend, or reformulate information contained in prior filings as a result of an SEC review, as well as the state in filings that we have inadequate control or expertise over financial reporting. 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.

We do not anticipate declaring any cash dividends on our common stock.

We have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future. Our current policy is to retain all funds and earnings for use in the operation and expansion of our business.

Maryland anti-takeover provisions and certain anti-takeover effects of our Charter and Bylaws may inhibit a takeover at a premium price that may be beneficial to our stockholders.

Maryland anti-takeover provisions and certain anti-takeover effects of our charter and bylaws may be utilized, under some circumstances, as a method of discouraging, delaying, or preventing a change of control of our Company at a premium price that would be beneficial to our stockholders. For more detailed information about these provisions, please see “Anti-takeover Law, Limitations of Liability and Indemnification” as follows:

Business Combinations

Under the Maryland General Corporation Law, some business combinations, including a merger, consolidation, share exchange, or, in some circumstances, an asset transfer or issuance or reclassification of equity securities, are prohibited for a period of time and require an extraordinary vote. These transactions include those between a Maryland corporation and the following persons (a “Specified Person”):

An interested stockholder who is defined as any person (other than a subsidiary) who beneficially owns 10% or more of the corporation’s voting stock or who is an affiliate or an associate of the corporation who, at any time within a two-year period prior to the transaction, was the beneficial owner of 10% or more of the voting power of the corporation’s voting stock; or an affiliate of 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. The board of directors of a Maryland corporation also may exempt a person from these business combination restrictions prior to the time the person becomes a Specified Person and may provide that its exemption be subject to compliance with any terms and conditions determined by the board of directors. Transactions between a corporation and a Specified Person are prohibited for five years after the most recent date on which such stockholder becomes a Specified Person. After five years, any business combination must be recommended by the board of directors of the corporation and approved by at least 80% of the votes entitled to be cast by holders of voting stock of the corporation and two-thirds of the votes entitled to be cast by holders of shares other than voting stock held by the Specified Person with whom the business combination is to be effected, unless the corporation’s stockholders receive a minimum price as defined by Maryland law and other conditions under Maryland law are satisfied.

A Maryland corporation may elect not to be governed by these provisions by having its board of directors exempt various Specified Persons, by including a provision in its charter expressly electing not to be governed by the applicable provision of Maryland law, or by amending its existing charter with the approval of at least 80% of the votes entitled to be cast by holders of outstanding shares of voting stock of the corporation and two-thirds of the votes entitled to be cast by holders of shares other than those held by any Specified Person. Our Charter does not include any provision opting out of these business combination provisions.

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. These provisions are referred to as the control share acquisition statute.

The control share acquisition statute does not apply to shares acquired in a merger, consolidation, or share exchange if the corporation is a party to the transaction, or to acquisitions approved or exempted prior to the acquisition by a provision contained in the corporation’s charter or bylaws. Our Bylaws include a provision exempting us from the restrictions of the control share acquisition statute, but this provision could be amended or rescinded either before or after a person acquired control shares. 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.

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. Under these provisions, a board of directors may divide itself into three separate classes without the vote of stockholders such that only one-third of the directors are elected each year. A board of directors classified in this manner cannot be altered by amendment to the charter 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:

In addition, a director elected to fill a vacancy under these provisions serves for the balance of the unexpired term instead of until the next annual meeting of stockholders. A board of directors may implement all or any of these provisions without amending the charter or bylaws and without stockholder approval. Although a corporation may be prohibited by its charter or by resolution of its board of directors from electing any of the provisions of the statute, we have not adopted such a prohibition. We have adopted a staggered board of directors with three separate classes in our charter and given the board the right to fix the number of directors, but we have not prohibited the amendment of these provisions. The adoption of the staggered board may discourage offers to acquire our common stock and may increase the difficulty of completing an offer to acquire our 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.

Effect of Certain Provisions of our Charter and Bylaws

In addition to the Charter and Bylaws provisions discussed above, certain other provisions of our Bylaws may have the effect of impeding the acquisition of control of our Company by means of a tender offer, proxy fight, open market purchases, or otherwise in a transaction not approved by our Board of Directors. 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. These provisions, however, also could have the effect of delaying, deterring, or preventing a change in control of our Company.

Our Bylaws provide that with respect to annual meetings of stockholders, (i) nominations of individuals for election to our Board of Directors and (ii) the proposal of business to be considered by stockholders may be made only pursuant to our notice of the meeting, by or at the direction of our Board of Directors, or by a stockholder who is entitled to vote at the meeting and has complied with the advance notice procedures set forth in our Bylaws.

Special meetings of stockholders may be called only by the chief executive officer, the board of directors or the secretary of our Company (upon the written request of the holders of a majority of the shares entitled to vote). At a special meeting of stockholders, the only business that may be conducted is the business specified in our notice of meeting. With respect to nominations of persons for election to our Board of Directors, nominations may be made at a special meeting of stockholders only pursuant to our notice of meeting, by or at the direction of our Board of Directors, or if our Board of Directors has determined that directors will be elected at the special meeting, by a stockholder who is entitled to vote at the meeting and has complied with the advance notice procedures set forth in our Bylaws.

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.

Our executive officers and large shareholders concentrated insider ownership of our common stock, which will limit your influence on corporate matters.

As of March 11, 2026, our executive officers and largest shareholders beneficially owned 17.84% based on 98,796,089 outstanding shares of common stock. As a result, our insiders have the ability to influence our management and affairs through the election and removal of our Board and all other matters requiring stockholder approval, including any future merger, consolidation, or sale of all or substantially all of our assets. This concentrated voting power could discourage others from initiating any potential merger, takeover, or other change-of-control transaction that may otherwise be beneficial to our stockholders. Further, this concentrated insider ownership will limit the practical effect of your influence over our business and affairs, through any stockholder vote or otherwise. Any of these effects could depress the price of our common stock.

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

ITEM 1C. CYBERSECURITY

Risk Management and Strategy

The Company’s cybersecurity processes are integrated into its broader risk management activities through periodic risk assessments, access-control reviews, third-party service provider oversight, incident-response protocols, backup and recovery procedures, and employee training. Management considers risks associated with cybersecurity primarily with its use of cloud-based systems and third-party vendors that host, process, or store Company information.

During the nine months ended December 31, 2025, we did not identify any cybersecurity threats that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition. However, despite our efforts, we cannot eliminate all risks from cybersecurity threats or provide assurances that we have not experienced undetected cybersecurity incidents. For additional information about these risks, see Part I, Item 1A, “Risk Factors” in this Transition Report on Form 10-KT.

Governance

ITEM 2. PROPERTIES

Our corporate headquarters is located in Potomac, Maryland. We own approximately 40,000 square feet of property used for general management and R&D operations. In addition, we have leases in the U.S. and internationally that are used for sales, storage, accounting, management, and R&D. During the Transition Period, the Company discontinued its leased facility in Vancouver, Washington, and no longer maintains a direct operating presence at that location. The Company believes its existing facilities, which are used by all reportable segments, are in good operating condition and suitable for conducting its business.

Please refer to Note 6 – “Property, Plant and Equipment”, and Note 7 – “Dispositions and Disposals”, for more information on Part II, Item 8.

ITEM 3. LEGAL PROCEEDINGS

The Company may be involved in legal proceedings, claims, and assessments arising in the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance.

As of December 31, 2025, the following material litigation is pending:

Engineering and Consulting Group SAS et al. v IGC Pharma Inc., case file no. 110016000050202247710 (Prosecutor’s Office 393 Sectional Economic Crimes Unit, Bogota, Colombia). The Company and the ECG corporation are in a contractual dispute. 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. In December 2023, the case was reviewed by the investigator and scheduled and accepted for a hearing by the prosecutor in calendar 2024. During the nine months ended December 31, 2025, the Company met with the prosecutors and pressed the urgency of moving the case through the legal system.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

PART II

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES

Our common stock is listed on the NYSE American under “IGC” symbol with CUSIP number 45408X308. The common stock of the Company is also quoted on the Frankfurt, Berlin, and Stuttgart (XETRA2) stock exchanges in Germany (ticker symbol: IGS1). We also have 91,472 units outstanding that can be separated into common stock. Ten units may be separated into one share of common stock. The unit holders are requested to contact the Company or our transfer agent, Continental Stock Transfer & Trust, to separate their units into common stock.

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 December 31, 2025, information regarding outstanding awards available under our compensation plans (including individual compensation arrangements) under which our equity securities may be delivered.

Holders of Record

As of March 11, 2026, we had approximately 73 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. Continental Stock Transfer & Trust Company is the transfer agent and registrar for our common stock.

Dividend policy

We have not declared or paid any dividends on our common stock. 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

During the nine months ended December 31, 2025, the Company entered into a Share Purchase Agreement (the “2025 SPA”) with multiple investors, relating to the sale and issuance by our company to investors of an aggregate of 2,803,333 shares of our common stock, for a total purchase price of $841,000, or $0.30 per share, subject to the terms and conditions set forth in the 2025 SPA. The investment is subject to customary closing conditions, including NYSE approval. As per the 2025 SPA, the investors received piggyback registration rights subject to certain restrictions. Shares are intended to be exempt from registration under the Securities Act, by virtue of the provisions of Section 4(a)(2) of Securities Act.

Purchases of equity securities by the issuer and affiliated purchasers

None.

ITEM 6. [RESERVED]

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following is a discussion and analysis of our financial condition and results of operations for the nine months ended December 31, 2025, and the nine months ended December 31, 2024. This discussion and analysis should be read in conjunction with our Consolidated Financial Statements and related notes and the other financial information included elsewhere in this Transition Report on Form 10-KT. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as those set forth under “Item 1.A. Risk Factors”, “Forward Looking Statements and Important Factors” and elsewhere in this Transition Report on Form 10-KT, our actual results may differ materially from those anticipated in these forward-looking statements.

The risks and uncertainties can cause actual results to differ significantly from those in our forward-looking statements or from those implied by historical results and trends. We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Overview

IGC Pharma, Inc. (“IGC,” the “Company,” “we,” “us,” or “our”) is a clinical-stage biotechnology company focused on the development of novel therapeutic candidates for neuropsychiatric and neurodegenerative disorders, with a primary emphasis on Alzheimer’s disease. Our core strategy is to address high-burden symptoms and underlying disease mechanisms through differentiated pharmaceutical formulations, supported by targeted clinical development and data-driven research approaches.

Our lead product candidate, IGC-AD1, is currently being evaluated in the CALMA clinical trial for the treatment of agitation in Alzheimer’s dementia, a neuropsychiatric condition affecting a substantial proportion of patients and associated with significant patient distress, caregiver burden, and healthcare utilization. In addition to symptom management, preclinical studies of IGC-AD1 suggest activity against biological pathways associated with Alzheimer’s disease pathology, supporting its potential evaluation in broader disease-modifying contexts.

Beyond IGC-AD1, our development pipeline includes additional early-stage therapeutic candidates targeting Alzheimer’s disease mechanisms, including TGR-63 and other investigational compounds currently in preclinical evaluation. These programs are intended to expand our long-term development portfolio while maintaining a disciplined focus on clinical execution and capital efficiency.

The Company is also developing MINT-AD, a proprietary, artificial intelligence, enabled data platform designed to support risk stratification and longitudinal assessment in Alzheimer’s disease using multimodal datasets. MINT-AD is intended as a clinical and research decision-support tool and is not currently approved as a diagnostic device.

Life Sciences Segment

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 lead drug, IGC-AD1, embodies this vision by tackling a critical challenge – managing agitation in Alzheimer’s dementia. Early results from our CALMA 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 6 to 12 weeks to show effects, we believe IGC-AD1 has the potential to act within two weeks. This potentially faster onset of action could significantly improve patient care and represent a potential breakthrough in managing Alzheimer’s-related agitation, although there can be no assurance thereof. In addition, we have created in-house wellness brands, available through online channels that are compliant with relevant federal, state, and local laws and regulations. We derive revenue from our in-house wellness non-pharmaceutical formulations that are sold over-the counter (“OTC”).

MINT-AD – Artificial Intelligence Platform

Overview

The Company is developing a proprietary Multimodal Interpretable Transformer for Alzheimer’s Disease (“MINT-AD”). MINT-AD is an artificial intelligence (“AI”) platform designed to enhance the detection and management of Alzheimer’s disease (“AD”) by providing clinicians with scalable, interpretable, and predictive diagnostic support. The platform is engineered to transition AD diagnostics from specialized, high-cost environments—such as neurology clinics utilizing Positron Emission Tomography (“PET”) scans—to primary care settings, rural areas, and underserved populations.

The Market Opportunity and Diagnostic Gap

According to the World Alzheimer Report, an estimated 400 million individuals globally may carry AD-related pathology prior to the onset of clinical symptoms. Currently, a significant “diagnostic gap” exists due to a lack of accessible early-detection tools for primary care physicians. This gap leads to delayed diagnoses, reduced eligibility for clinical trials, and sub-optimal patient outcomes. MINT-AD is intended to bridge this gap by offering a cost-effective, non-invasive alternative for early cognitive risk assessment.

Proprietary Technology and Architecture

MINT-AD leverages a “Transformer” architecture—a state-of-the-art deep learning model—to harmonize and analyze diverse, multimodal datasets. The platform processes a wide array of data sources to produce clinically actionable insights, including:

Competitive Advantage: Explainable AI (“XAI”) and Regulatory Alignment A core component of MINT-AD is its “interpretability.” Unlike “black box” AI models that provide outputs without clinical context, MINT-AD utilizes “attention mechanisms” to identify and highlight the specific data points—such as regional brain atrophy or genetic markers—that drive its risk assessments.

Management believes this interpretability provides a significant competitive advantage in two key areas:

Use of MINT-AD

The Company is positioning MINT-AD as a practical, AI-driven assistant for healthcare providers. The platform is designed to support the clinical workflow through three primary objectives:

Our Business Strategy

The business strategy includes:

We believe developing a drug for both symptom and disease-modifying agents has less risk due to the need for expensive multi-year trials. However, there is considerable upside and significant value creation to the extent we obtain a first-in-class advantage, of which there can be no assurance. If we were to obtain a first-in-class advantage, such an advantage could result in significant growth if and when an approved drug such as IGC-AD1 launches.

We believe that additional investment in clinical trials, AI, R&D, facilities, marketing, advertising, and the acquisition of complementary products and businesses will be critical to the ongoing growth of the Life Sciences segment. Although there can be no assurance, we believe 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. Although there can be no assurance, we believe this strategy can improve our existing products and lead to the creation of new products that can provide treatment options for multiple conditions, symptoms, and side effects. Management is committed to its core short-term goals, completion of the CALMA trial on IGC-AD1, and deploying AHA and MINT-AD.

Change in Fiscal Year and Transition Period

In December 2025, our Board of Directors (the “Board”) approved a change in the fiscal year end of the Company from March 31 to December 31. As a result of this change, we are filing this Transition Report on Form 10-KT for the nine-month transition period ended December 31, 2025. The change in fiscal year ends on a prospective basis and does not adjust operating results for prior periods. References to our previous fiscal years mean the fiscal years ending on March 31. The Company’s fiscal year 2026 commenced on January 1, 2026. References herein to “Transition Period” refer to the nine-month period ended December 31, 2025.

This Transition Report covers nine months and should be read accordingly. Period-to-period comparisons may be impacted by the shorter reporting period and are not necessarily indicative of full-year results. This Transition Report covers a nine-month period (April 1 - December 31, 2025) due to our fiscal year change. Accordingly, results are not directly comparable to our prior full-year results. To enhance comparability, we have provided both: (i) Unaudited Nine months ended December 31, 2024 (comparable period), and (ii) Audited Year ended March 31, 2025 (prior full fiscal year)

The Global Economic Environment

In addition to the industry-specific factors, such as regulations around cannabinoid research, we are exposed to economic cycles. 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.

Business Updates

During the Transition Period, the Company continued to advance the CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer’s disease.

Clinical trial activities are subject to inherent uncertainties, including patient enrollment rates, protocol adherence, regulatory oversight, and data integrity, any of which could materially affect trial timelines or results. The CALMA trial remains ongoing to complete 146 patients.

Results of Operations

The following table presents an overview of our results of operations for the nine months ended December 31, 2025, and 2024:

Statement of Operations (in thousands)

Revenue – Revenue was approximately $869 thousand and $941 thousand for the nine months ended December 31, 2025, and 2024, respectively. Revenue in both periods was primarily derived from our Life Sciences segment, which involved providing white-label manufactured products and sales of in-house products, among others. There is a decrease in revenue as our core focus is on advancing IGC-AD1, completing the CALMA trial, and developing MINT-AD for the early diagnosis of Alzheimer’s disease. In addition, there was a planned transition period associated with the disposition of the Company’s Vancouver manufacturing facility pursuant to the Favorable Contract between the Company and the Buyer. During this period, production and fulfilment activities were reduced as operations were transferred to the Buyer under the Favorable Contract. For more information, please refer to Note 7 – “Dispositions and Disposals”.  

Cost of revenue – Cost of revenue amounted to approximately $572 thousand for the nine months ended December 31, 2025, compared to $476 thousand for the nine months ended December 31, 2024, this represents gross margins of 34% and 49%, respectively. The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products in the Life Science segment. Typically, the gross margin in the Life Sciences business will fluctuate from one quarter to another based on the mix within the Life Sciences business between white label, private label, and branded products. There is insufficient revenue to model or project gross margins. In the near term, the Company expects gross margins to remain lower than historical levels as operations stabilize and supply chain arrangements are transitioned to third-party manufacturers. While the transition may result in a temporary reduction in gross margins, management believes the transaction provides long-term operational efficiencies and improved financial flexibility.

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. During the nine months ended December 31, 2025, SG&A expenses increased by approximately $281 thousand or 7% to approximately $4.1 million as compared to approximately $3.8 million during the nine months ended December 31, 2024. The increase of $281 thousand is attributed to an increase in non-cash expenses of approximately $349 thousand related to share-based compensation and a one-time expense of approximately $25 thousand, partially offset by decreases in depreciation, investor relations, insurance, and Vancouver-related operating expenses.

Research and Development (R&D) expenses – R&D expenses were attributed to our Life Sciences segment. The R&D expenses increased by approximately $1.3 million or 48% to approximately $4 million during the nine months ended December 31, 2025, from approximately $2.7 million. It is primarily attributable to the progression of CALMA trials on IGC-AD1 and pre-clinical studies on the other small molecule assets. We anticipate increased R&D expenses as the development of our other small molecule assets targeting Alzheimer’s and the CALMA trial on Alzheimer’s expands.

Other Income, net – Other net income increased by approximately $3.5 million or 3,173% during the nine months ended December 31, 2025. As a result, the total other income for the nine months ended December 31, 2025, and 2024, is approximately $3.6 million and $110 thousand, respectively. Other income includes interest and rental income, dividend income, profit from the sale of assets, unrealized gains from investments, net income, and income from scrap sales. Increase in other income is attributed to approximately $1.1 million profit from the disposition of assets and approximately $2.1 million non-cash benefit of disposal of subsidiary from the reclassification of accumulated foreign currency translation adjustments from accumulated other comprehensive income to earnings, please refer to Note -7 “Dispositions and Disposals”, and received the tax credit of approximately $262 thousand.

Liquidity and capital resources

Our sources of liquidity are cash and cash equivalents, funds raised through the ATM offering, cash flows from operations, short-term and long-term borrowings, and short-term liquidity arrangements. The Company continues to evaluate various financing sources and options to raise working capital to help fund current research and development programs and operations. The Company does not have any material long-term debt, capital lease obligations, or other long-term liabilities except as disclosed in this report. Please refer to Note 12, “Commitments and contingencies”, Note 11, “Loans and Other Liabilities,” and Note 9, “Leases” in Item 1 of this report for further information on the Company’s commitments and contractual obligations.

Pursuant to the Master Loan and Security Agreement (the “Credit Agreement”) with O-Bank, Co., Ltd., the Company successfully obtained a working capital credit facility totaling $12 million. In addition, the Company raised approximately $5.2 million in exchange for approximately 14 million shares, which includes the 2025 Share Purchase Agreements (“2025 SPAs”) with multiple investors, relating to the sale and issuance by our company to the investors of an aggregate of 3,583,330 shares of our common stock, for a total purchase price of $1,075,000, or $0.30 per share, subject to the terms and conditions set forth in the 2025 SPAs. The equity transactions and the credit facility serve to minimize ongoing liquidity requirements and ensure the Company’s ability to sustain its operations.

On October 27, 2023, the Company entered into a Sales Agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (the Agent) pursuant to which the Company may offer and sell, from time to time, through the Agent, as sales agent and/or principal, shares of its common stock having an aggregate offering price of up to $60 million, subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (the “Offering”). As of December 31, 2025, the Company has sold approximately $4.5 million, gross under the Sales Agreement.

On September 29, 2025, the Company entered into the Sale Agreement, pursuant to which the Company sold assets associated with its Vancouver, Washington facility for approximately $2.7 million, subject to the satisfaction of certain closing conditions. The facility had previously generated an annual net cash outflow of approximately $600 thousand from fixed overhead and non-core manufacturing operations. The sale eliminates the recurring cash loss while preserving preferential supply rights that allow the Company to continue sourcing formulations at competitive pricing from 2027 onward. The Company also retains a contingent 10% interest in any future sale of the business by the Buyer. Please refer to Note 7 – “Dispositions and Disposals” and Item 5 – “Other Information”.

The Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP during the nine months ended December 31, 2025, which is approximately valued at $38 thousand as of December 31, 2025. The investment is classified as a short-term marketable security and is marked to market each period. The Company does not directly hold cryptocurrencies or other digital tokens. 

The equity transactions and the credit facility serve to minimize ongoing liquidity requirements and ensure the Company’s ability to sustain its operations. Furthermore, the Company intends to raise additional funds through private placements and ATM offerings, subject to market conditions, although there can be no assurance that such financing efforts will be successful. The Company expects to raise further capital for its research and development initiatives as and when it is able to do so, in an ATM offering or private placement. 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. In addition, subject to limitations on the amount of capital that can be raised, the Company expects to utilize its shelf registration on a statement on Form S-3 to raise capital through at-the-market offerings or otherwise. Please refer to Note 13 – “Securities”, for more information.

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. 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 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.

Cash and cash equivalents

Cash and cash equivalents increased by approximately $495 thousand to $900 thousand in the nine months ended December 31, 2025, from $405 thousand as of March 31, 2025, an increase of approximately 122%. Working capital decreased by approximately $1.0 million to a deficit of $366 thousand as of December 31, 2025, from a positive balance of $639 thousand as of March 31, 2025, representing a decrease of approximately 157%. The decrease of approximately $684 thousand was primarily attributable to inventory associated with disposition of the Company's Vancouver, Washington manufacturing facility pursuant to the Favorable Contract, as described in Note 7 – 'Dispositions and Disposals' .

Operating Activities

Net cash used in operating activities for the nine months ended December 31, 2025, was approximately $4.7 million. It consists of a net loss of approximately $4.1 million, a negative impact on cash due to non-cash expenses of approximately $802 thousand, and a positive change in operating assets and liabilities of approximately $228 thousand. Non-cash expenses consist of an amortization and depreciation charge of approximately $324 thousand, stock-based expenses of approximately $2.1 million, profit on sale of fixed assets of approximately $1.1 million, approximately $2.1 million non-cash benefit of disposal of subsidiary from the reclassification of accumulated foreign currency translation adjustments from accumulated other comprehensive income to earnings, and approximately $12 thousand unrealized loss from the short-term investments. In addition, changes in operating assets and liabilities had a positive impact of approximately $228 thousand on cash, of which a net positive impact of approximately $195 thousand is due to an increase in deposits and advances, and a negative impact of approximately $248 thousand is due to increase in accrued and other liabilities, a net positive impact of approximately $132 thousand is due to an increase in accounts payable, a net positive impact of approximately $87 thousand is due to an increase in operating lease asset, and net other current assets and liabilities of approximately $62 thousand.

Net cash used in operating activities for the nine months ended December 31, 2024, was approximately $4.1 million. It consists of a net loss of approximately $5.9 million, a positive impact on cash due to non-cash expenses of approximately $1.6 million, and a positive change in operating assets and liabilities of approximately $224 thousand. Non-cash expenses consist of an amortization and depreciation charge of approximately $464 thousand and stock-based expenses of approximately $1.2 million. In addition, changes in operating assets and liabilities had a positive impact of approximately $224 thousand on cash, of which a net negative impact of approximately $190 thousand is due to an increase in deposits and advances, and a positive impact of approximately $251 thousand is due to increase in accrued and other liabilities, a net positive impact of approximately $107 thousand is due to an increase in inventory and net other current assets and liabilities of approximately $56 thousand.

Investing Activities

Net cash used in investing activities for the nine months ended December 31, 2025, was approximately $22 thousand, which is comprised of expenses of approximately $604 thousand for the acquisition and development of intangible assets, approximately $50 thousand for the investment in short term investment, and adjusted with approximately $632 thousand, net for the sale of property, plant, and equipment.

Net cash used in investing activities for the nine months ended December 31, 2024, was approximately $300 thousand, which is comprised of expenses of approximately $222 thousand for the acquisition and development of intangible assets, and approximately $78 thousand for the net purchase of property, plant, and equipment.

Financing Activities

Net cash provided by financing activities was approximately $5.2 million for the nine months ended December 31, 2025, which is comprised of net proceeds from issuance of equity stock of approximately $5.2 million, and re-payment of the loan of approximately $3 thousand. Please refer to Note 13 – “Securities”, for more information. 

Net cash provided by financing activities was approximately $3.6 million for the nine months ended December 31, 2024, which is comprised of net proceeds from issuance of equity stock of approximately $3.6 million, and offset by the re-payment of the loan of approximately $3 thousand. Please refer to Note13 – “Securities”, for more information.

Treasury Strategy and Capital Allocation Considerations

Management continually evaluates opportunities to optimize the Company’s capital structure and enhance stockholders’ equity while maintaining adequate liquidity to support operations. Since early 2024, we have assessed the potential use of digital assets, including bitcoin and other cryptocurrencies, as part of our treasury management strategy. We believe that allocating a portion of our cash reserves to digital assets could diversify our treasury holdings, potentially enhance our balance sheet if the assets appreciate, and align with emerging best practices of certain public companies.

We began implementing this policy during the nine months ended December 31, 2025. The timing, size, and type of investments will be based on prevailing market conditions, liquidity needs, and risk management considerations. These investments involve material risks, as discussed in Item 1A – “Risk Factors”.

Critical Accounting Policies and Estimates

The preparation of financial statements and related disclosures in conformity with U.S. GAAP and the Company’s discussion and analysis of its financial condition and operating results require the Company’s management to make judgments, assumptions, and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. We base our estimates on historical experience, as appropriate, and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from these estimates, and such differences may be material. For further information on significant accounting policies, see the discussion in Note 2 to the consolidated financial statements included in Item 8 of this Transition Report on Form 10-KT.

Management believes that the following accounting policies are the most critical to understanding and evaluating our consolidated financial condition and results of operations.

Digital Asset Investments

During the nine months ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP, which was valued at approximately $38 thousand as of December 31, 2025. The investment is classified as a short-term marketable security and is marked to market each period. The Company does not directly hold cryptocurrencies or other digital tokens. Holdings in ETPs will be accounted for as equity securities under ASC 321, Investments – Equity Securities, and measured at fair value with changes recognized in earnings. Fair value will be determined using quoted prices in active markets (Level 1 inputs).

For direct holdings of digital assets, the Company will present in the notes a roll-forward of activity, including the opening balance, additions, dispositions, gains, and losses recognized during the period, and the ending balance, as well as any significant concentrations and restrictions.

Revenue Recognition

The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers (ASC 606). 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 Company recognizes revenue from trading, rental, and product sales as follows:

I. Identify the contract with the customer.

II. Identify the contractual performance obligations.

III. Determine the amount of consideration/price for the transaction.

IV. Allocate the determined amount of consideration/price to the performance obligations.

V. Recognize revenue when or as the performing party satisfies performance obligations.

The consideration/price for the transaction (performance obligation(s)) is determined as per the agreement or invoice (contract) for the services and products in the Life Sciences segment.

In the Life Sciences segment, the revenue from the wellness and lifestyle business is recognized once goods have been sold to the customer and the performance obligation has been completed. In retail sales, we offer consumer products through our online stores. Revenue is recognized when control of the goods is transferred to the customer. This generally occurs upon our delivery to a third-party carrier or to the customer directly. Revenue from white label services is recognized when the performance obligation has been completed and the output material has been transferred to the customer.

Net sales disaggregated by significant products and services for the nine months ended December 31, 2025, and 2024, and twelve months ended March 31, 2025, are as follows:

Property, plant, and equipment

Property, plant, and equipment are recorded at cost, net of accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets. Please refer to Note 2, “Significant accounting policies” and Note 6, “Property, plant, and equipment” of Item 8 in this document, for more information. Property, plant, and equipment are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If property, plant, and equipment are considered to be impaired, an impairment loss is recognized.

During the nine months ended December 31, 2025, there was no impairment loss on PPE.

Software Development Costs

The Company is developing two proprietary software platforms intended to be commercialized:

In accordance with ASC 985-20, Software to Be Sold, Leased, or Marketed, the Company capitalizes development costs incurred after technological feasibility has been established and before the software is available for general release. Costs incurred during the research, planning, or preliminary design phase are expensed as incurred.

Capitalized costs include direct labor, third-party development services, cloud computing infrastructure directly related to model development and deployment, and associated overhead. These costs are amortized on a straight-line basis over their estimated useful lives, typically five to ten years, beginning when the software is ready for its intended commercial use.

As of December 31, 2025, the Company capitalized approximately $1.4 million in software development costs. Please refer to Note 5, “Intangible Assets,” for more information.

Foreign currency translation

IGC operates in India, U.S., and Colombia, and a substantial portion of the Company’s financials are denominated in the Indian Rupee (INR), or the Colombian Peso (COP). As a result, changes in the relative values of the U.S. Dollar (USD), the INR, or the COP affect financial statements.

The accompanying financial statements are reported in USD. The INR, and COP are the functional currencies for certain subsidiaries of the Company. The translation of the functional currencies into U.S. dollars is performed for assets and liabilities using the exchange rates in effect at the balance sheet date and for revenues and expenses using average exchange rates prevailing during the reporting periods. Adjustments resulting from the translation of functional currency financial statements to reporting currency are accumulated and reported as other comprehensive income/(loss), a separate component of shareholders’ equity. Transactions in currencies other than the functional currency during the year are converted into the functional currency at the applicable rates of exchange prevailing when the transactions occurred. Transaction gains and losses are recognized in the consolidated statements of operations. The exchange rates used for translation purposes are as follows:

Cybersecurity

We have a cybersecurity policy in place and have implemented tighter cybersecurity measures to safeguard against hackers. Complying with these security measures and compliances is expected to incur further expenses. During the nine months ended December 31, 2025, and the twelve months ended March 31, 2025, there were no known or detected material breaches in cybersecurity.

Off-balance sheet arrangements

We do not have any outstanding derivative financial instruments, off-balance sheet guarantees, interest rate swap transactions, or foreign currency forward contracts. Furthermore, we do not have any retained or contingent interest in assets transferred to an unconsolidated entity that serves as credit, liquidity, or market risk support to such entity. We do not have any variable interest in an unconsolidated entity that provides financing, liquidity, market risk, or credit support to us or that engages in leasing, hedging, or research and development services with us.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Item 7A does not apply to us because we are a smaller reporting company.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Report of Independent Registered Public Accounting Firm

To the shareholders and the board of directors of IGC Pharma, Inc.

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of IGC Pharma, Inc. and its subsidiaries (the "Company") as of December 31, 2025 and March 31, 2025 and the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows, for the nine months period ended December 31, 2025 and for the year ended March 31, 2025 and the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as at December 31, 2025 and March 31, 2025, and the consolidated results of its operations and its cash flows for the nine months period ended December 31, 2025 and for the year ended March 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters. 

Manohar Chowdhry & Associates

Chartered Accountants

We have served as the Company’s auditor since 2018.

Chennai, India

March 18, 2026

UDIN: 26237830KZULXM2410

IGC Pharma, Inc.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

The accompanying notes should be read in connection with these consolidated financial statements.

IGC Pharma, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except loss per share and share data)

The accompanying notes should be read in connection with these consolidated financial statements.

IGC Pharma, Inc.

CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(in thousands)

The accompanying notes should be read in connection with these consolidated financial statements.

IGC Pharma, Inc.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)