IGC Pharma Reports Accelerated Q2 Progress and Strengthened Financial Focus: CALMA Trial Passes 50% Enrollment Milestone, Strategic Divestiture Optimizes Capital

Rhea-AI Summary

IGC Pharma (NYSE American: IGC) reported Q2 FY2026 results for the quarter ended September 30, 2025, and outlined operational progress.

Key items: Phase 2 CALMA enrollment surpassed 50%; a strategic divestiture of a Vancouver manufacturing facility closed for $2.7 million producing an approximate $1.1 million non-cash profit and eliminating $600,000 in annual expenses; other net income rose 2,407%; R&D spending increased 73% to $1.6 million; revenue declined ~54% to $191,000; net loss was $1.8 million ($0.02/share). The company noted NIA recognition for its AI work and ongoing pipeline advances including IGC-M3 and patent allowance for IGC510.

Positive

• Phase 2 CALMA enrollment >50% (accelerates completion timeline)
• Divestiture generated $2.7M proceeds and ~$1.1M non-cash profit
• Eliminated $600,000 in annual operating expenses from divestiture
• Other net income increased +2,407% driven by the divestiture
• No draw on the $12M credit agreement preserves liquidity runway

Negative

• R&D expenses increased 73% to $1.6M (higher burn rate)
• Revenue declined ~54% to $191,000 for the quarter
• Net loss of $1.8M ($0.02/share) maintained despite spending changes
• Authorized common shares increased from 150M to 600M (potential dilution)

Insights

Senior biotech financial analyst

Progress in enrollment, a small non‑core asset sale, and external AI recognition improve operational runway and program momentum.

IGC advanced its Phase 2 CALMA program past the midpoint of enrollment (50% enrolled) and expanded sites internationally and domestically, which should shorten the path to trial completion and broaden patient diversity. The company executed a strategic divestiture that produced a fair‑value receipt of 2.7 million, a reported non‑cash profit of ~1.1 million, and eliminated ~600 thousand in annual operating expenses, while retaining preferential supply rights tied to future sale proceeds; together these items materially increase near‑term financial flexibility without drawing on the 12 million credit facility.

Risks and dependencies include continued enrollment progress to complete the Phase 2 CALMA study and the translation of the NIA recognition into measurable commercial partnerships for the AI platform. R&D spend rose to 1.6 million in the quarter (a 73% increase) and the company reported a net loss of 1.8 million (or 0.02/share), so cash conservation and execution on planned collaborations for MINT‑AD will determine how long the company sustains accelerated development.

Watch for three measurable near‑term milestones: completion of CALMA enrollment (timeline implied by >50% enrolled), initiation of pilot collaborations for MINT‑AD, and progress on the IGC‑M3 preclinical program; expect updates over the next several quarters (second half of fiscal 2026 horizon).

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 (3 Months ended 9/30/2025)	Change from Q2 FY 2025	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.

View the original press release on ACCESS Newswire

FAQ

What progress did IGC (IGC) report for the Phase 2 CALMA trial on November 17, 2025?

IGC reported that CALMA enrollment surpassed 50%, with expansion to new domestic and international sites to accelerate completion.

How much did IGC receive from the Vancouver facility divestiture and what was the financial impact?

IGC sold the Vancouver facility for $2.7 million, recording an approximate $1.1 million non-cash profit and eliminating $600,000 in annual operating expenses.

What were IGC's Q2 FY2026 revenue and net loss reported on November 17, 2025?

Revenue was approximately $191,000 (down ~54% year-over-year) and net loss was $1.8 million or $0.02 per share.

How did IGC's operating income change in Q2 FY2026?

Other net income rose by 2,407%, primarily due to the non-cash profit from the divestiture.

What capital or financing actions did IGC announce in Q2 FY2026?

Shareholders approved increasing authorized common stock from 150 million to 600 million, and the company had no draw on its $12 million credit agreement as of Sept 30, 2025.

Did IGC receive any recognition or intellectual property updates on November 17, 2025?

Yes—IGC received a special award from the NIA for AI work and received a Notice of Allowance from the USPTO for patent application IGC510.