{"url_path":"/sec/igc/10-q/2026/item-1a","section_key":"item-1a","section_title":"Item 1A Risk Factors**","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-15","source_url":"https://www.sec.gov/Archives/edgar/data/1326205/0001185185-26-001885-index.html","accession_number":"0001185185-26-001885","cik":"0001326205","ticker":"IGC","issuer_name":"IGC Pharma, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1326205/0001185185-26-001885-index.html","primary_entity_key":"0001326205","primary_entity_name":"IGC Pharma, Inc."},"word_count":850,"has_tables":true,"body_markdown":"**Item\n1A. Risk Factors**\n\n \n\nThe\nfollowing are the material changes to the risk factors disclosed in Part I, Item 1A, “Risk Factors” in our Transition Report\non Form 10-KT for the period ended December 31, 2025, filed with the SEC on March 18, 2026.\n\n \n\n**Risks\nRelated to Our Clinical Development and IGC-AD1**\n\n** **\n\nOur\nbusiness is highly dependent on the successful development of our lead product candidate, IGC-AD1, and we may not successfully complete\nclinical development or obtain regulatory approval.\n\n \n\nOur\nability to advance IGC-AD1 depends on the successful execution and completion of our ongoing Phase 2 CALMA clinical trial. We may experience\ndelays in patient enrollment, including failure to achieve targeted enrollment within expected timelines, or at all. Clinical trials\nare inherently complex and subject to numerous risks, including delays in site initiation, variability in site performance, patient recruitment\nchallenges, protocol deviations, and unforeseen operational or logistical issues. Any such delays could increase development costs, extend\ntimelines, and adversely affect our business and financial condition.\n\n \n\nEven\nif we complete the CALMA clinical trial, the results may not demonstrate sufficient safety, tolerability, or efficacy to support continued\ndevelopment or regulatory approval. Clinical trial outcomes are inherently uncertain and may be influenced by factors including trial\ndesign, statistical assumptions, patient population characteristics, dosing regimens, and variability in individual patient responses.\nNegative or inconclusive results could delay or prevent further development and materially adversely affect the value of IGC-AD1.\n\n \n\nThe\ntiming of key clinical milestones, including database lock and the availability of topline data, is uncertain and subject to change.\nDelays in data collection, data cleaning, monitoring, or analysis could postpone the release of clinical results, which may adversely\naffect investor expectations, our stock price, and our ability to raise capital.\n\n \n\nWe\nmay not obtain regulatory approval for IGC-AD1. The U.S. Food and Drug Administration (“FDA”) and other regulatory authorities\nmay require additional preclinical or clinical studies, impose delays in the review process, or determine that our data are insufficient\nto support approval. Regulatory requirements are evolving and may change during the course of development. Failure to obtain regulatory\napproval would prevent us from commercializing IGC-AD1 and could materially adversely affect our business.\n\n \n\nWe\nwill require substantial additional capital to continue the development of IGC-AD1 and our other product candidates. Our ability to obtain\nfinancing depends on market conditions and other factors beyond our control, and such financing may not be available on acceptable terms,\nor at all. If we are unable to secure sufficient funding, we may be required to delay, scale back, or discontinue our development programs.\n\n \n\nThe\nbiopharmaceutical industry is highly competitive, and our product candidates may face significant competition. Competing therapies, including\nthose currently approved or under development for Alzheimer’s disease or agitation, may demonstrate superior efficacy, safety,\nor cost-effectiveness. In addition, changes in the standard of care could reduce the commercial opportunity for IGC-AD1, even if approved.\n\n \n\nWe\nare developing and utilizing artificial intelligence and data-driven tools, including our MINT-AD platform, to support research and development\nactivities. These technologies are emerging and subject to significant technical, regulatory, and operational risks. They may not perform\nas expected, may produce inaccurate or non-generalizable results, and may be subject to evolving regulatory oversight, including potential\nFDA regulation of software-based tools. Any limitations or failures of these technologies could adversely affect our clinical development\nefforts.\n\n \n\nOur\noperations and clinical development activities may also be adversely affected by general economic and geopolitical conditions, including\nsupply chain disruptions, labor shortages, regulatory changes, and global market volatility. These factors may impact clinical trial\nexecution, access to clinical sites and personnel, and overall development timelines.\n\n \n\n**Risks\nRelated to Our Convertible Debt Instruments**\n\n** **\n\nThe\nCompany has issued convertible promissory notes that contain variable-rate conversion features, which could result in substantial dilution\nto existing stockholders. Upon the occurrence and continuation of an event of default, the holders of these notes may convert outstanding\namounts into shares of the Company’s common stock at a conversion price equal to a discount to the market price, including at 75%\nof the lowest trading price of the Company’s common stock during a specified period preceding conversion. As of March 31, 2026,\nthe aggregate principal amount of such convertible instruments was approximately $353 thousand. Conversions at discounted prices may\nresult in the issuance of a significant number of shares, particularly in periods of stock price volatility or decline, which could materially\ndilute the ownership interests of existing stockholders and adversely affect the market price of the Company’s common stock. Although\nthese instruments include a 4.99% beneficial ownership limitation and a 19.99% share issuance cap in compliance with applicable NYSE\nAmerican listing standards, such limitations may not prevent substantial dilution over time, particularly if conversions occur in multiple\ntransactions or if stockholder approval is obtained to exceed applicable thresholds. In addition, the existence of these convertible\ninstruments may create downward pressure on the trading price of the Company’s common stock, limit the Company’s ability\nto obtain additional financing on favorable terms, and could result in increased volatility in the market price of its securities.\n\n \n\n|\nMarch 31, 2026, Form 10-Q\n\n \n\n32\n\n[Table of Contents](#TableOfContents)"}