UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

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

For Fiscal Year Ended March 31, 2025.

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

For the transition period from to

Commission file number: 001-32830

IGC PHARMA, INC.

(Exact Name of Registrant as Specified in Its Charter)

Maryland		20-2760393
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

10224 Falls Road, Potomac, Maryland		20854
(Address of Principal Executive Offices)		(Zip Code)

(301) 983-0998

(Registrant’s telephone number, including area code)

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

Common Stock		IGC		NYSE American LLC
(Title of each class)		(Trading Symbol)		(Name of each exchange on which registered)

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.

Large accelerated filer ☐		Accelerated filer ☐
Non-accelerated filer ☑		Smaller reporting company ☑
Emerging growth company ☐

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 September 30, 2024, the last business day of the Registrant’s most recently completed second fiscal quarter, was approximately $29,724,689. 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.

83,891,586 shares of our common stock were outstanding as of June 20, 2025.

DOCUMENTS INCORPORATED BY REFERENCE

None

IGC PHARMA, INC.

FORM 10-K

FOR THE FISCAL YEAR ENDED MARCH 31, 2025

TABLE OF CONTENTS

		Page
PART I

Item 1.	Business	5
Item 1A.	Risk Factors	25
Item 1B.	Unresolved Staff Comments	39
Item 1C.	Cybersecurity	39
Item 2.	Properties	40
Item 3.	Legal Proceedings	40
Item 4.	Mine Safety Disclosures	40

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities	41
Item 6.	[Reserved]	42
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	42
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	51
Item 8.	Financial Statements and Supplementary Data	51
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	78
Item 9A.	Controls and Procedures	78
Item 9B.	Other Information	78
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	78

PART III

Item 10.	Directors, Executive Officers, and Corporate Governance	79
Item 11.	Executive Compensation	85
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	87
Item 13.	Certain Relationships and Related Transactions, and Director Independence	88
Item 14.	Principal Accountant Fees and Services	88

PART IV

Item 15.	Exhibits and Financial Statement Schedules	91
Item 16.	Form 10-K Summary	92
Signatures		93

	●	the sufficiency of our existing cash and cash equivalents and marketable securities to fund our future operating and capital expenses;

	●	our ability to successfully implement and deploy our artificial intelligence initiatives;

	●	our disposal of non-core Company assets;

	●	our ability to successfully register trademarks and patents, create and market new products and services, and achieve customer acceptance in the industries we serve;

	●	current and future economic and political conditions, including in North America, Colombia, Europe, and India;

	●	our ability to accurately predict the future demand for our products and services;

	●	our ability to successfully market our products in countries and states where our products are legal;

	●	our ability to maintain a stock listing on a national securities exchange;

	●	our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain;

	●	our ability to timely complete regulatory filings;

	●	our ability to obtain the U.S. Food and Drug Administration (FDA) approval for an Investigational New Drug Application (INDA) and to successfully run medical trials, including a Phase 2 trial for IGC-AD1;

	●	our reliance on third parties to conduct clinical trials and for the manufacture of IGC-AD1 for clinical and non-clinical studies and clinical trials;

	●	our financial performance;

	●	the outcome of medical trials that are conducted on our Investigational Drug Candidates and products;

	●	our ability to fund the costs of clinical trials and other related expenses;

	●	our ability to maintain our intellectual property position and our ability to maintain and protect our intellectual property rights;

	●	competition and general acceptance of alternative, pharmaceutical, and nutraceutical therapies;

	●	our ability to effectively compete and our dependence on market acceptance of our brands and products within and outside the United States;

	●	federal and state legislation and administrative policy regulating our formulations;

	●	our ability (based in part on regulatory concerns) to license our products to processors that can produce pharmaceutical-grade formulations;

	●	our ability to obtain and protect patents for the use of our formulations;

	●	our ability to obtain and install equipment for processing and manufacturing our products;

	●	our ability to successfully navigate disruptions of information technology systems or data security breaches that could adversely affect our business; and

	●	our ability to successfully implement our strategy.

Asset	Target Indication	Mechanism of Action	Development Stage	Key Milestones
IGC- AD1	Agitation in Alzheimer’s dementia	CB1 receptor partial agonist; reduces neuroinflammation and restores neurotransmitter balance	Phase 2 clinical trial (CALMA study)	Interim Phase 2 data analysis suggests cognitive improvements in the active treatment group versus the placebo group.
TGR-63	Early to moderate Alzheimer’s disease	Disrupts amyloid-beta (Aβ) plaque formation; crosses blood-brain barrier	Preclinical	Demonstrated favorable safety profile; advancing towards clinical trials
LMP	Alzheimer’s disease	Targets neuroinflammation, neurotransmitter imbalance, and inflammasome-3	Preclinical	Bioequivalence to IGC-AD1 anticipated in 2025
IGC-M3	Early-stage Alzheimer’s disease	Inhibits Aβ plaque aggregation	Preclinical	Toxicology studies planned for mid-2025
IGC-1C	Alzheimer’s disease and metabolic disorders	Targets tau protein phase separation; potential GLP-1 receptor agonist	Preclinical	Exhibits strong binding affinity to tau protein; potential for weight loss applications
IGC-1A	Metabolic disorders (e.g., type 2 diabetes, obesity)	Potential GLP-1 and GIP receptor agonist; CB1 receptor inverse agonist	Preclinical	Identified through AI modeling; toxicology and dosing studies underway


	●	Publish scientific findings in peer-reviewed journals to strengthen clinical credibility and visibility: - IGC Pharma actively disseminates research through peer-reviewed publications to validate its scientific approach, enhance transparency, and support regulatory engagement. This strategy reinforces the Company’s reputation within the medical and investor communities and underpins the advancement of its drug development programs.

	●	a network of doctors, scientists with Ph.D. degrees, and intellectual property legal experts with a sophisticated understanding of drug discovery, research, FDA filings, intellectual protection, and product formulation;

	●	knowledge of various cannabinoid strains, their phytocannabinoids profile, extraction methodology, and impact on various pathways;

	●	knowledge of plant and cannabinoid-based combination therapies;

	●	knowledge of research and development in the field;

	●	approximately thirty-one (31) patent applications out of which our portfolio includes twelve (12) granted patents. For more information, please refer to Item I, “Business” of Part I;

	●	facilities and a team with experience in manufacturing, marketing, and selling products. These competencies have enabled us to make progress on our business goals, specifically completing the Phase 1 clinical trial of IGC-AD1, which has the potential to positively impact on the lives of millions of patients suffering from the symptoms of Alzheimer’s disease, subject to FDA approval.

Domain	Cohort 1 (n=7) qd			Cohort 2 (n=6) bid			Cohort 3 (n=5) tid
NPI (Agitation)	Baseline	Day	Day	Baseline	Day	Day	Baseline	Day	Day
	Day 0	10	15	Day 0	10	15	Day 0	10	15
Mean Score	4.7	3.3	3	4.3	2.1	1.5	4.2	3.2	1.4
Mean Change	-	1.4	1.7	-	2.2	2.8	-	1	2.8
Mean Change%	-	37%	48%	-	53%	67%	-	23%	67%
p-values	-	0.058	0.045	-	0.085	0.05	-	0.29	0.045

	Week 2	Week 6 (EOT)
Scale	LS Mean Change (95% CI)	p value	Cohen’s d	LS Mean Change (95% CI)	p value	Cohen’s d
CMAI	-12.19 (-25.52, 1.14)	.071	0.79	-10.46 (-20.53, -0.4)	.042	0.79


Figure 10: In the Novel Object Recognition test, mice treated with TGR-63 showed increased exploration of a new object over a familiar one, indicating enhanced learning capacity. (Adv. Therap. 2021, 4 2000225)*.		Figure 11: During the Morris Water Maze test, mice treated with TGR-63 exhibited improved spatial memory, with decreased latency in finding the target compared to the untreated group. (*Adv. Therap. 2021, 4 2000225).

	●	Obtain and maintain strong patent and proprietary protection;

	●	Secure necessary licenses for third-party intellectual property;

	●	Protect our trade secrets and proprietary know-how;

	●	Enforce our rights against infringement; and

SEC Form 10-K filed by IGC Pharma Inc.