IGC-M3

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC), a clinical-stage pharmaceutical company, has announced its financial results for the fiscal year ended March 31, 2024 (“Fiscal 2024”). Full Fiscal Year Highlights In March 2024, the Company announced positive interim results from its ongoing Phase 2 trial for IGC-AD1. The interim data have shown promising results in reducing Alzheimer’s agitation, which is a major challenge for patients and their caregivers alike. This development marks a significant step forward in the fight against Alzheimer’s and brings hope to millions of people affected by this devastating disease. In January 2024, the Company announced details about its drug candidate TGR-63, which specifically targets amyloid-beta plaque, which has the potential to significantly improve the treatment of Alzheimer’s disease. Subsequently, on February 1, 2024, the Company announced further positive results from preclinical studies of TGR-63, demonstrating its potential as an effective treatment for Alzheimer’s disease. These studies demonstrated that TGR-63 was successful in reducing plaque burden in Alzheimer’s cell lines and animal models, making it a promising therapeutic candidate for the disease. The Company had significant achievements in our foreign intellectual property rights as the Company received three (3) patents. One (1) patent relates to Method and Composition for CNS Disorder and two (2) patents relate to Method and Composition for Treating Pain. In July 2023, IGC Pharma and the University of Los Andes (Faculty of Engineering) signed a Master Cooperation Agreement to conduct innovative research in Artificial Intelligence (“AI”) applied to the pharmaceutical industry. We are harnessing the power of AI to develop early detection models, optimize clinical trials, and explore new applications for our drugs. During fiscal year ended March 31, 2024, the Company entered into Share Purchase Agreements (the “SPAs”) with multiple investors, resulting in approximately $6 million in gross proceeds. $2.5 million of the gross proceeds was received in April 2024 subsequent to the close of the fiscal year end. In addition, the Company also received a $12 million credit line from O Bank to support the Company’s expanded operations and ongoing clinical trials. In May 2024, subsequent to Fiscal 2024, the Company announced patient enrollment at Neurostudies, Inc., in a Phase 2 trial investigating IGC-AD1, a partial CB1r agonist with anti-neuroinflammatory properties and an inflammasome inhibitor, to treat Agitation in dementia due to Alzheimer’s disease. Ram Mukunda, CEO of IGC Pharma, commented, “During the fiscal year we accomplished multiple key milestones and significantly advanced our strategy to bring to market treatments to fight Alzheimer’s – a devastating disease affecting a growing patient population around the globe. The most important achievement in our development pipeline was the positive interim results on IGC-AD1, a significant development in the fight against Alzheimer’s and a reflection of our commitment to advancing our product portfolio and delivering value to all stakeholders. Furthermore, the positive results from preclinical studies of TGR-63 demonstrated its success in reducing plaque burden in Alzheimer’s cell lines and animal models, making it a promising therapeutic candidate for the disease. Looking ahead, we are increasingly optimistic about our prospects to build upon these positive results and deliver long-term value to stakeholders. We appreciate the dedication and hard work of our team, whose efforts have been instrumental in achieving these results. We remain focused on executing our strategic initiatives and are excited about the opportunities that lie ahead.” Financial Summary In Fiscal 2024, the Company generated approximately $1.3 million in revenue, representing an increase from the $911 thousand generated in Fiscal 2023. The primary source of revenue in both years was from the Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others. The increase in revenue derived from the Company’s commitment to its current strategy of driving sales in formulations both as branded and white-labeled products in the Life Science segment. Approximately 10%-12% of revenue in both years was derived from the infrastructure segment. The Company reported selling, general, and administrative (“SG&A”) expenses for Fiscal 2024 at approximately $6.7 million, representing a decrease of approximately $2 million, or 21%, compared to the $8.5 million recorded in Fiscal 2023. This decline in SG&A expenses is attributable to a reduction in non-cash expenses and costs related to employees as well as legal & professional services. In Fiscal 2024, the Company reported research and development (“R&D”) expenses of approximately $3.8 million, representing an increase of $312 thousand or 9% compared to approximately $3.5 million in Fiscal 2023. The increase in R&D expenses is primarily attributed to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on TGR-63, indicating the Company’s dedication to advancing its product pipeline. As the development of TGR-63 and the Phase 2 trial on Alzheimer’s gain momentum, the Company anticipates further increases in R&D expenses. To streamline operations and dedicate resources to our core pharmaceutical business, we strategically divested non-core assets. This resulted in a positive impact on our focus and a one-time impairment of PP&E of approximately $3.3 million. Net loss for Fiscal 2024 was approximately $13 million or $0.22 per share, compared to approximately $11.5 million or $0.22 per share for Fiscal 2023. The net loss for Fiscal 2024 includes a one-time impairment of PP&E of approximately $3.3 million. About IGC Pharma, Inc. IGC Pharma Inc. ("IGC") is focused on Alzheimer’s disease, developing innovative solutions to address this devastating illness. The Company’s mission is to transform the landscape of Alzheimer’s treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer’s disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2 clinical trial for agitation in dementia associated with Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 disrupts the progression of Alzheimer’s by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer’s. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer’s therapy. In addition to its drug development pipeline, IGC Pharma seeks to leverage artificial intelligence ("AI") for Alzheimer’s research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer’s. Forward-looking Statements This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission (“SEC”) filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 24, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. < Financial Tables to Follow> IGC Pharma, Inc. CONSOLIDATED BALANCE SHEETS (in thousands, except share data) March 31, 2024 ($) March 31, 2023 ($) ASSETS Current assets: Cash and cash equivalents 1,198 3,196 Accounts receivable, net 39 107 Short term investments - 154 Inventory 1,540 2,651 Asset held for sale 720 - Deposits and advances 208 358 Total current assets 3,705 6,466 Non-current assets: Intangible assets, net 1,616 1,170 Property, plant and equipment, net 3,695 8,213 Claims and advances 688 1,003 Operating lease asset 198 326 Total non-current assets 6,197 10,712 Total assets 9,902 17,178 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable 773 530 Accrued liabilities and others 1,567 1,368 Total current liabilities 2,340 1,898 Non-current liabilities: Long-term loans 137 141 Other liabilities 20 21 Operating lease liability 84 207 Total non-current liabilities 241 369 Total liabilities 2,581 2,267 Commitments and Contingencies – See Note 12 Stockholders’ equity: Preferred stock, $0.0001 par value: authorized 1,000,000 shares, no shares issued or outstanding as of March 31, 2024, or March 31, 2023. Common stock and additional paid-in capital, $0.0001 par value: 150,000,000 shares authorized; 66,691,195 and 53,077,436 shares issued and outstanding as of March 31, 2024, and March 31, 2023, respectively. 124,409 118,965 Accumulated other comprehensive loss (3,423) (3,389) Accumulated deficit (113,665) (100,665) Total stockholders’ equity 7,321 14,911 Total liabilities and stockholders’ equity 9,902 17,178 These financial statements should be read in connection with the accompanying notes on Form 10-K for fiscal year ending March 31, 2024, filed with the SEC on June 24, 2024. IGC Pharma, Inc. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except loss per share and share data) Years Ended March 31, 2024 ($) 2023 ($) Revenue 1,345 911 Cost of revenue (612 ) (469 ) Gross profit 733 442 Selling, general and administrative expenses (6,758 ) (8,552 ) Research and development expenses (3,773 ) (3,461 ) Operating loss (9,798 ) (11,571 ) Impairment loss on PPE (3,345 ) - Other income, net 143 65 Loss before income taxes (13,000 ) (11,506 ) Income tax expense/benefit - - Net loss attributable to common stockholders (13,000 ) (11,506 ) Foreign currency translation adjustments (34 ) (421 ) Comprehensive loss (13,034 ) (11,927 ) Net loss per share attributable to common stockholders: Basic and diluted $ (0.22 ) $ (0.22 ) Weighted-average number of shares used in computing loss per share amounts: 58,839,868 52,576,258 These financial statements should be read in connection with the accompanying notes on Form 10-K for fiscal year ending March 31, 2024, filed with the SEC on June 24, 2024.

-- Study Deepens Understanding of Treatments for Alzheimer’s Patients, Enabling More Effective Treatments -- POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”), today announced the publication of a significant research article in the European Society of Medicine Journal. The study investigates the effects of CYP2C9 polymorphisms on the pharmacokinetics (“PK”) of delta-9-tetrahydrocannabinol (“THC”) and its active metabolite in Alzheimer’s disease (“AD”) patients. The publication is titled “A study on CYP2C9 polymorphism in Puerto Rican Alzheimer's Patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol” and is available at . The article highlights the importance of understanding genetic variations in CYP2C9, an enzyme crucial for drug metabolism, and its impact on the efficacy and safety of treatments involving THC. IGC Pharma’s leading drug candidate IGC-AD1 was tested in a Phase 1 multiple ascending dose (“MAD”) trial with a Puerto Rican population. The study examined the effect of CYP2C9 polymorphisms on THC metabolism in AD patients. Key findings revealed significant variations in THC and OH-THC half-life among different CYP2C9 phenotypes, suggesting the need for personalized dosing strategies in AD patients. The publication of the article aligns with IGC Pharma’s commitment to the inclusion of underrepresented populations in clinical research developing innovative Alzheimer's therapies. Puerto Rico, with an elevated AD rate of 12% compared to 10.7% in the continental US, was chosen to ensure comprehensive data collection and improve the accessibility of effective therapies. Ram Mukunda, CEO of IGC Pharma, commented, “We are very pleased to announce the publication in the prestigious European Society of Medicine journal. This publication is a testament to our dedication to pioneering research in Alzheimer’s disease. Understanding the genetic factors influencing drug metabolism is critical for developing safe and effective treatments. We are proud to contribute to the scientific community with this important study, reinforcing our commitment to enhancing patient care and delivering shareholder value through scientific innovation.” Dr. Jagadeesh S. Rao, the lead scientist of the study, stated, “Our findings emphasize the critical need for personalized medicine in treating Alzheimer’s disease. The significant variability in THC metabolism due to CYP2C9 polymorphisms highlights the importance of considering genetic profiles when dosing. This research paves the way for more tailored therapeutic approaches, potentially improving outcomes for AD patients.” IGC Pharma is currently conducting a Phase 2 trial with IGC-AD1, a partial CB1r agonist with anti-neuroinflammatory properties and an inflammasome inhibitor, to treat agitation from symptoms of dementia caused by Alzheimer’s. Neuroinflammation, neurotransmitter imbalance, loss of CB1r, and inflammasome-3 have been implicated as causes of agitation and aggression in patients suffering from Alzheimer’s disease. IGC-AD1 contains THC as one of its two active pharmaceutical agents, the principal psychoactive cannabinoid found in Cannabis. IGC-AD1 is a first-of-its-kind THC-based-formulation undergoing a formal Phase 2 clinical trial in Alzheimer’s disease. About IGC Pharma, Inc. IGC Pharma Inc. (“IGC”) is focused on Alzheimer’s disease, developing innovative solutions to address this devastating illness. The Company’s mission is to transform the landscape of Alzheimer’s treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer’s disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2 clinical trial for agitation in dementia associated with Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 disrupts the progression of Alzheimer’s by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer’s. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer’s therapy. In addition to its drug development pipeline, IGC Pharma seeks to leverage artificial intelligence (“AI”) for Alzheimer’s research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer’s. Forward-looking Statements This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission (“SEC”) filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.