Company Accelerates Phase 2 Alzheimer's Program and Gains National Institute on Aging (NIA) Recognition for AI Leadership
POTOMAC, MARYLAND / ACCESS Newswire / November 17, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced financial results for the quarter ended September 30, 2025 (Second Quarter of Fiscal Year 2026) and provided a compelling update on its accelerated clinical and strategic progress.
Q2 FY 2026 Strategic and Operational Highlights
Strategic Financial Discipline: Executed a strategic divestiture of a non-core manufacturing facility for $2.7 million (fair value, September 29, 2025), booking a non-cash profit of approximately $1.1 million, while eliminating $600 thousand in annual operating expenses. This transaction secures long-term preferential supply rights of future sale proceeds, materially enhancing financial flexibility.
Clinical Momentum Reaches Midpoint: Achieved more than 50% patient enrollment in the Phase 2 CALMA trial of IGC-AD1 for agitation associated with Alzheimer's dementia (announced September 22, 2025), significantly advancing the timeline to trial completion.
AI Leadership Recognized: Received a prestigious special award from the National Institute on Aging (NIA) for excellence in code clarity, reproducibility, and usability in Alzheimer's detection, validating IGC's AI-first approach (September 9, 2025).
Expanding Pipeline Scope: Reported encouraging preclinical data for IGC-M3, a small-molecule candidate designed to hit multiple Alzheimer's disease pathways, including amyloid aggregation, mitochondrial dysfunction, and neuroinflammation (August 12, 2025).
"This quarter reflects the disciplined execution of our dual strategy in clinical trials and artificial intelligence, positioning IGC to create meaningful shareholder value," said Ram Mukunda, CEO of IGC Pharma. "We've accelerated our lead Alzheimer's program past the 50% enrollment mark, demonstrating our operational focus. Simultaneously, we converted a previously cash-negative manufacturing facility into a favorable contract that strengthens our balance sheet. The NIA award underscores that our unique AI platform is not just a concept, but a recognized tool accelerating Alzheimer's diagnostics. We are confident this progress sets the stage for rapid advancement in the quarters ahead."
Operational & Pipeline Progress in Detail:
Phase 2 CALMA Trial Expansion: The ongoing Phase 2 CALMA trial for IGC-AD1 was strategically expanded to new international and domestic sites, including Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada, and Lynn Health Science Institute (LHSI) in Oklahoma City, Oklahoma. This expansion is designed to accelerate the remaining enrollment and enhance patient diversity.
Patent Protection Secured: The Company received a Notice of Allowance from the USPTO for its patent application IGC510 (US 17/613,909), a proprietary method for treating individuals suffering from stammering, stuttering, or Tourette's syndrome.
Financial Summary:
Financial Metric |
Q2 FY 2026 |
Change from |
Key Takeaway |
|---|---|---|---|
R&D Expenses |
$1.6 million |
73% Increase |
Reflects accelerated progression of Phase 2 CALMA trial and pre-clinical small molecule assets. |
Other Net Income |
$1.2 million |
2,407% increase |
Driven primarily by the $1.1 million non-cash profit from the strategic divestiture of the Vancouver facility. |
Net Loss per Share |
$1.8 million or $0.02/share |
Relatively stable vs. Q2 FY 2025. |
Loss maintained despite significant increase in R&D investment. |
Cash Position/Flexibility |
No draw on the $12 million Credit Agreement with O-Bank as of September 30, 2025. |
Maintained |
Preserves liquidity runway. |
Shareholder Approval |
Shareholders approved an increase in authorized common stock from 150 million to 600 million. |
Strategic |
Provides essential flexibility for future financing and strategic partnerships. |
Note on Revenue: Revenue for the quarter was approximately $191 thousand, a decrease of 54% from the prior year, primarily due to the planned transition period associated with the disposition of the Company's Vancouver manufacturing facility and the focused shift toward advancing the core pharmaceutical pipeline. This planned transition pursuant to the new favorable contract is expected to yield long-term financial benefits.
IGC expects continued strong momentum heading into the second half of fiscal 2026, with key strategic priorities focused on pipeline execution and AI commercialization:
Clinical Acceleration: Completing patient enrollment in the CALMA Phase 2 study.
AI Monetization: Initiating key collaborations for piloting MINT-AD (IGC's AI diagnostic platform) with academic and clinical partners.
Pipeline Deepening: Advancing the promising IGC-M3 preclinical asset.
Strategic Partnerships: Evaluating strategic partnerships across AI diagnostics and Alzheimer's therapeutics.
Financial Stewardship: Strengthening operational efficiency while preserving cash runway and financial flexibility.
IGC Pharma's financial statements for the quarter ended September 30, 2025, filed on Form 10-Q, are available on www.sec.gov.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
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 27, 2025, 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. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Contact Information:
Rosalyn Christian / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
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