POTOMAC, Md. / Aug 08, 2024 / Business Wire / IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the first fiscal quarter of 2025 ended June 30, 2024.

Q1 FY2025 Company’s Highlights

• On April 9, 2024, the Company welcomed Pablo Arbelaez, Ph.D., a renowned AI expert and researcher, to support the development of the Phase 2 clinical trial of IGC-AD1, the lead therapeutic candidate addressing agitation in Alzheimer’s disease.
• On April 16, 2024, the Company announced that interim data from its Phase 2 clinical trial demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.
• On May 28, 2024, the Company announced patient enrollment at Neurostudies, Inc. in Port Charlotte, Florida, for its ongoing Phase 2 clinical trial investigating IGC-AD1, the lead investigational drug, as a potential treatment for agitation in Alzheimer’s disease.
• On June 25, 2024, the Company shared positive pre-clinical results for TGR-63, showing its potential in combating Alzheimer’s disease in an Alzheimer’s mouse model.
• The Company and O-Bank, Co. Ltd. extended the Master Loan and Security Agreement for $12 Million, by one year. The Extension is effective July 8, 2024. The Company paid a facility fee of $84,000 for the facility as set out in Form 8-K filed on July 29, 2024.

Ram Mukunda, CEO of IGC Pharma, commented, “The first quarter of fiscal 2025 was marked by significant milestones in our Alzheimer’s research portfolio, underscoring our strategic focus on our innovations. The progress in our Phase 2 clinical trial for IGC-AD1, highlighted by interim data demonstrating a clinically significant reduction in agitation, validates the immense potential of our lead investigational drug. Additionally, the positive pre-clinical outcomes for TGR-63 underscore its promise as a transformative therapy for Alzheimer’s, advancing us closer to delivering a novel solution for this critical unmet need. We are strategically positioned to continue expanding our clinical trial footprint and patient enrollment throughout fiscal 2025 as we continue to drive toward commercialization while maximizing operational efficiency and leveraging our unique vertically integrated model.”

Financial Summary

During the three months ended June 30, 3024, the Company generated approximately $272 thousand in revenue, representing a decrease of 51% compared to the approximately $555 thousand generated during the three months ended June 30, 2023. The decrease in revenue is attributed to the completion of our legacy Infrastructure project in India as well as some white-label project in the U.S., both of which comprised approximately 50% of the June 2023 revenue. The Company is committed to its current strategy of driving sales in formulations in the Life Science segment.

The Company reported Selling, General, and Administrative (“SG&A”) expenses during the three months ended June 30, 2024, of approximately $1.7 million, representing an increase of approximately $23 thousand, or 1%, compared to the three months ended June 30, 2023.

During the three months ended June 30, 2024, the Company reported Research and Development (“R&D”) expenses of approximately $889 thousand, representing an increase of approximately $142 thousand or 19% compared to the three months ended June 30, 2023. The increase is primarily attributable to the progression of Phase 2 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 Phase 2 trial on Alzheimer’s expand.

The net loss for the three months ended June 30, 2024, was approximately $2.4 million or $0.03 per share, compared to approximately $2.1 million or $0.04 per share for three months ended June 30, 2023.

As of June 30, 2024, the Company has not used any of the $12 million available under the Credit Agreement with O-Bank.

About IGC Pharma (dba IGC):

IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease with the mission to transform patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical stages, focusing on tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia associated with Alzheimer’s (clinicaltrials.gov, NCT05543681). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict affinity to other neurological disorders, GLP-1, GIP, CB1 receptors, among others. With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer’s and related conditions.

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 incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Q filed with the SEC on August 07, 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.

These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 07, 2024.

These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended June 30, 2024, and was filed with the SEC on August 07, 2024.