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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 13, 2026

 

 

IGC PHARMA, INC.

(Exact name of registrant as specified in charter)

 

Maryland   001-32830   20-2760393
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (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)

 

Not applicable

(Former Name or Former Address, if Changed since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.0001 par value   IGC   NYSE American

 

Indicate by check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure

 

On July 13, 2026, IGC Pharma, Inc. (“IGC” or the “Company”) furnished an updated investor presentation (the “Investor Presentation”). A copy of the Investor Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part and with modifications or supplements from time to time, in meetings and communications with investors, analysts, potential strategic partners and others, and at conferences and other business events.

 

The information contained in the Investor Presentation is summary information and should be considered in the context of the Company’s filings with the Securities and Exchange Commission and its other public disclosures. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to update or revise the Investor Presentation except as required by applicable law.

 

The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information therein that is required to be disclosed solely by reason of Regulation FD.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   IGC Pharma Investor Presentation, dated July 2026.
104   Cover Page Interactive Data File, formatted in Inline XBRL

 

Forward-Looking Statements:

 

This Current Report on Form 8-K and the Investor Presentation furnished as Exhibit 99.1 contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company’s ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, obtain regulatory approvals, successfully develop and commercialize its product candidates, and achieve market acceptance, as well as other factors discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-KT and subsequent reports filed with the SEC.

 

Forward-looking statements include, without limitation, statements regarding the anticipated timing, enrollment, conduct and results of the CALMA Phase 2 trial of IGC-AD1; the potential safety or efficacy of IGC-AD1; interim, blinded or preliminary clinical observations and the extent to which they may or may not be predictive of final results; comparisons to other products, product candidates or companies; the potential size of any addressable market; and the possibility that favorable Phase 2 results or other clinical, regulatory or business developments could result in an increase or inflection in the Company’s valuation.

 

Any valuation metrics, valuation ranges, comparable-company analyses or potential valuation-inflection scenarios contained in the Investor Presentation are illustrative and hypothetical, are based on assumptions and circumstances that may not occur, and do not constitute an appraisal or estimate of the fair or intrinsic value of the Company or its securities, a projection or forecast of future financial performance, a price target, investment advice or a recommendation to purchase or sell any security. Comparable companies may differ materially from the Company in their stage of development, clinical results, product profiles, financial resources, market opportunities and other respects. There can be no assurance that the CALMA trial will produce favorable results or that, even if favorable results are obtained, the Company’s stock price or market capitalization will increase or achieve any valuation referenced or implied in the Investor Presentation.

 

Interim and blinded clinical data are preliminary, are not statistically powered to demonstrate efficacy, may change as additional data become available, and are not necessarily predictive of topline or final results. IGC-AD1 is an investigational product candidate and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Cross-trial comparisons are not based on head-to-head clinical trials and are inherently limited.

 

Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update or revise any forward-looking statement except as required by applicable law.

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

  IGC Pharma, Inc.
     
Dated: July 13, 2026    
  By: /s/ Ram Mukunda
    Name:  Ram Mukunda
    Title: Chief Executive Officer

 

2

 

EX-99.1 2 igcex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

Advancing Alzheimer’s Care. Improving Lives. NYSE American: IGC

SAFE HARBOR : Forward - Looking Statements and Important Cautionary Information: This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward - looking statements include statements regarding the timing, conduct and results of the CALMA Phase 2 trial; the safety and efficacy of IGC - AD1; regulatory and commercialization plans; market opportunities; and the possibility that favor able clinical results or other developments could result in an increase or inflection in IGC Pharma’s valuation. Forward - looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. These risks include the possibility of delays in enrollment, database l ock or data readout; unfavorable or inconclusive clinical results; safety findings; regulatory delays or denials; financing requirements; competition; and the other risks described in the Company’s filings with the U.S. Securities and Exchange Commission. Forward - looking statements speak only as of the date of this presentation, and the Company undertakes no obligation to update them ex cep t as required by law. Any valuation metrics, comparable - company analyses, valuation ranges or potential valuation - inflection scenarios presented are illustrative and hypothetical. They are based on assumptions and circumstances that may not occur and do not constitute a projection, forecast, appraisal, estimate of fair or intrinsic value, price target, investment recommendation or gu arantee of future stock price, market capitalization or financial performance. Comparable companies may differ materially from IGC Ph arm a, and there can be no assurance that favorable Phase 2 results, if obtained, would result in any increase in the Company’s stoc k p rice or valuation. Blinded pooled analyses combine participants assigned to IGC - AD1 and placebo and do not permit assessment of treatment effect or efficacy. Observed changes may reflect treatment effect, placebo response, regression to the mean, backgr oun d care, trial participation, attrition or other factors. Such data are preliminary, may change following database cleaning and unb linding, and may not predict topline or final results. IGC - AD1 is investigational and has not been approved by the FDA or any other regul atory authority. Cross - trial comparisons are not head - to - head comparisons and are inherently limited. IGC Pharma, Inc. · NYSE American: IGC

OVERVIEW OF IGC IGC Pharma, Inc. · NYSE American: IGC

INVESTMENT OPPORTUNITY IN ALZHEIMER’S DISEASE (AD) Illustrative Potential Valuation Scenarios → ~$30M ~$300 – $500M ~$2 – $4B 7/2026 Current market cap Near - term Potential inflection based on positive Phase 2 results Long - term Potential inflection if disease - modifying catalysts succeed Valuation scenarios are illustrative and hypothetical, not projections, forecasts, price targets, or guarantees.

THE PROBLEM One in three Americans over 85 has Alzheimer’sKM1

AGITATION IN ALZHEIMER’S 76% of patients experience agitation or other neuropsychiatric symptoms 139M people projected to live with dementia by 2050 - Alzheimer’s is the leading cause Agitation is defined as physical or verbal aggression, restlessness, pacing, among others. Agitation drives earlier institutionalization, higher mortality, and devastating caregiver burden. IGC Pharma, Inc. · NYSE American: IGCKM1

OUR SOLUTION IGC Pharma is Developing a Major TherapyKM1

IGC - AD1 Therapeutic Targets Patent - protected Oral liquid — practical for elderly Alzheimer’s patients and caregivers Multiple neurobiological pathways targeted by IGC - AD1 Neuroinflammation CB1 receptor signaling Neurotransmitter regulation IGC - AD1 INVESTIGATIONAL IGC Pharma, Inc. · NYSE American: IGC

IGC - AD1 IGC Pharma, Inc. · NYSE American: IGC

PHASE 1: NPS MEASURED BY NPI - 12 IGC - AD1 showed improvement in Neuropsychiatric Symptoms (NPS) in Phase 1 Trial Across qd , bid, & tid dosing, IGC - AD1 led to an overall improvement in NPS as measured by the NPI - 12 KEY DOMAINS SHOWING IMPROVEMENT: Agitation Anxiety Depression Caregiver Distress Total NPI - 12 Baseline Day 15 Total Average NPI Score 31.5 14.8 ** Cohort 1 % Change 53.02% p value: 0.005 22.2 12.4 * Cohort 2 % Change 44.14% p value: 0.024 16.0 7.9 * Cohort 3 % Change 50.63% p value: 0.021 IGC Pharma, Inc. · NYSE American: IGC

PHASE 2 - CALMA TRIAL STATUS The multicenter CALMA trial of IGC - AD1 for agitation in Alzheimer’s dementia. 146 Target number of participants >80% of participants have completed dosing Previously reported interim analysis showed a reduction in agitation at 2 weeks NEAR - TERM CATALYSTS Completion of enrollment + topline readout IGC Pharma, Inc. · NYSE American: IGC 6 – 10 weeks for the current standard of care, Brexpiprazole, based on published data. vs KM1

UNITED STATES & CANADA ADDITIONAL SITES • Dent Neurosciences Research Center • BayCare Health System • ClinCloud • Global Medical Institutes Florida • Neurostudies • Tandem Intermediate • Tekton Research • Integrative Clinical Trials • Ichor Research • Lynn Health Science Institute • Senior Adults Specialty Research • Dominion Medical Associates • University of Puerto Rico • SCB Research Center SITES CONDUCTING CALMA IGC Pharma, Inc. · NYSE American: IGC

CALMA PHASE 2 · PROGRESS REPORT BLINDED POOLED DATA Blinded pooled data include both IGC - AD1 and placebo participants and cannot establish treatment effect or efficacy; observed changes may not predict unblinded results 0 - 5 - 10 - 15 Baseline Week 2 Week 6 Visit LS Mean Change from Baseline (CMAI) −13.6 −14.9 WEEK 2 −13.6 LS mean change in CMAI from baseline (n=107) WEEK 6 −14.9 LS mean change in CMAI from baseline BLINDED POOLED INVESTIGATIONAL IGC Pharma, Inc. · NYSE American: IGC n=(104)KM1

CALMA INTERIM RESULTS (N=26): IGC - AD1 COMPARED TO BREXPIPRAZOLE DATA Brexpiprazole is the current standard of care to treat agitation in AD In interim analysis, IGC - AD1 showed numerically earlier and larger changes than those reported in selected published Brexpiprazole studies. IGC AD - 1: Potentially faster acting, larger effect size, and excellent safety profile * CMAI Least Squared mean change from baseline at EOT comparing active and placebo groups A) IGC - AD1 1ml BID trial (NCT05543681) and Brexpiprazole trial 0.5 to 2 mg flexible doses trial (NCT01922258). * p<0.05, ** p<0.01, b p<0.001; Mixed Model of Repeated Measures. SE: S ta ndard Error; CMAI: Cohen - Mansfield Agitation Inventory. • This is a not a direct comparison Grossberg GT, Kohegyi E, Mergel V, et al. Am J Geriatr Psychiatry. 2020;28(4):383 - 400. doi:10.1016/j.jagp.2019.09.009 IGC Pharma, Inc. · NYSE American: IGCKM1

INTERIM DATA (n=26) - POTENTIAL FOR REDUCING SLEEP DISTURBANCE Clinical reduction in sleep & nighttime disturbance at week 2 sustained through End of Trial (EOT) - 1 - 2 - 3 - 4 - 5 1 2 EOT WEEK Placebo IGC - AD1 Active Placebo WEEK 2 Sleep Disturbance Reduced 71% (p=0.012) WEEK 6 (EOT) Sleep Disturbance Reduced 78% (p=0.02) (1) NPI - 12 Sleep Subdomain Least Squared Mean change from baseline comparing placebo and active groups in the interim data IGC Pharma, Inc. · NYSE American: IGCKM1

APPROVED DRUGS (COMPETITION) AXS - 05 (Dextromethorphan and bupropion) A combination therapy approved in April 2026. IGC Pharma, Inc. · NYSE American: IGC Rexulti (Brexpiprazole) Atypical antipsychotic approved in May 2023 BLACK BOX WARNING

IGC HAS SEVERAL PLATFORMS WITH IP Foreign Patents Granted US Patents Granted Pending Patent Applications Description Lead Drug Candidate - 2 1 ● Composition & Method for treating CNS Disorders IGC - AD1 1 1 9 ● Composition & Method for treating CNS Disorders IGC - AD1 - - 6 ● Naphthalene Monoimide Derivatives with ability to impact A β protein build - up. TGR - 63 - - 5 ● Naphthalene Monoimide Derivatives with ability to impact Tau aggregation and neurofibrillary tangle formation IGC - 1C - - 4 ● Naphthalene Monoimide Derivatives with ability to impact A β plaque build - up and neurofibrillary tangle formation IGC - M3 1 1 0 ● Naphthalene diimide Derivatives with ability to self - assemble molecular interactions for biological and nonbiological systems including some cancers IGC - 514 - - 1 ● Composition, Synthesis & Medical use of Hybrid Molecule IGC - LMP - 2 - ● Composition & Method for treating Seizures in humans & Cats/Dogs Epilepsy - 1 - ● Natural formulation with Cyproheptadine for treating Cachexia & Eating Disorders Eating Disorders - 1 - ● Formulation for Treating Stuttering & Symptoms of Tourette Syndrome Stuttering & Tourette Syndrome 2 2 - ● Formulation containing Cobalamin and method for pain management Pain - - 1 ● Multi agent system for end - to - end heterogenous data set harmonization IGC - AHA - - 1 ● Explainable multimodal transformer - based system for neurodegenerative diseases clinical support MINT - AD - - 1 ● Methods and compositions for treating sleep disturbance and sleep – wake cycle disruption in alzheimer’s disease Sleep 4 10 29 We have 29 active patent applications which are distributed among the US, Canada, Europe, Colombia, India, Brazil, Japan and Hong Kong and 14 granted patents in US, Canada, Europe and Mexico. In - house patents / applications Patents / applications acquired through exclusive license agreements

POTENTIAL CATALYSTS Laura Sanchez , Quality Control Manager & Dr. Jagadeesh Rao, Principal Scientist at IGC Pharma Headquarters in Potomac, MarylandKM1KM2

MARKET: BLOCKBUSTER OPPORTUNITY North America & Europe market sizing for agitation in AD EST. ANNUAL REVENUE $3B 3% adoption $5B 5% adoption $10B 10% adoption ASSUMPTIONS 15M* Individuals with AD 11M Agitation in AD (76%) $750 Monthly price * Sources: Alzheimer’s Association, Alzheimer Europe, Harvard School of Public Health, Alzheimer’s Disease International IGC Pharma, Inc. · NYSE American: IGC

VALUATION INFLECTION EXAMPLES ~$30M $350 – $750M IGC today Potential Post Phase 2 valuation COMPANY PHASE 2 POST Positive PHASE 2 PEAK DIFFERENCE Annovis (ANVS) AD/PD $200M (2021) → $700M (2021) ~$500M Axsome (AXSM) AD $50M (2019) → $800M (2019) ~$750M Anavex AD/CNS $150M (2016) → $500M (2018) ~$350M IGC Pharma, Inc. · NYSE American: IGC Valuation scenarios are illustrative and positive phase 2 results, if obtained, may not result in any increase in IGC’s stock pr ice or market capitalization.

POTENTIAL VALUATION INFLECTION Investors today are positioned before principal value - inflection events ~ $30m Current valuation July 10 2026 $350m – $750m 4 - 9 months 2026 - 2027 Positive phase 2 results $2B – $4B ~36 - 48 months 2029+ Positive phase 2 results in a disease - modifying therapy IGC Pharma, Inc. · NYSE American: IGC Valuation scenarios are illustrative and positive phase 2 results, if obtained, may not result in any increase in IGC’s stock price or market capitalization.

EXECUTIVE MANAGEMENT & BOARD EXECUTIVE MANAGEMENT Ram Mukunda Biomedical Engineer CEO Claudia Grimaldi Psychologist, MBA, Vice President INDEPENDENT BOARD Richard Prins Chairman James Moran Former Congressman Terry Lierman Human Virology (IHV) CORPORATE ADVISORY BOARD Terry McAuliffe Former Governor of Virginia Howard Gutman Ambassador to Belgium ( rtd .) IGC Pharma, Inc. · NYSE American: IGC

TEAM IGC Pharma, Inc. · NYSE American: IGC Dr. Juan Manuel Orjuela, MD Neuropsychiatrist Dr. Diego Rodriguez, Ph.D. Medicinal Chemist Evelyn Gutiérrez, Eng. MPH Sr. Manager - CALMA Paola Ruiz, MS Sr. Manager AI Systems Maria Tangarife, MS Neuroscientist Margarita Venegas, MS Clinical Psychologist Dr. Varduhi Ghazaryan, MD - MPH - Medical Director Dr. Jagadeesh Rao, Ph.D. Doctorate in Neuroscience Principal Scientist Dr. Sudip Sinha, Ph.D. Doctorate in Naturopathy CALMA - Operations

BOARD OF ADVISORS IGC Pharma, Inc. · NYSE American: IGC Prof. Elliot Hong, MD Professor Psychiatrist Prof. Chuanhai Cao, PhD Professor of Pharmaceutical Science s Prof. Jeffrey Cummings , MD, ScD, Chair of the ACTC Neuropsychiatric Symptoms Committee Prof. Pablo Arbelaez, PhD Professor Biomedical Engineering Prof. Joseph Fortunak , PhD Professor Chemistry and Pharmaceutical Science s Dr. Munish Mehra , PhD Statistics PHARMACEUTICAL SCIENCES, PSYCHIATRY, NEUROLOGY, STATISTICS, AND AI

CONTACT Ram Mukunda ram@igcpharma.com Claudia Grimaldi cgrimaldi@igcpharma.com www.igcpharma.com THANK YOU Advancing Alzheimer’s Care . Improving Lives . NYSE American: IGC