IGC Pharma Reports 65% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial

Rhea-AI Summary

IGC Pharma (NYSE:IGC) announced it has reached 65% patient enrollment in the Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer’s disease as of December 9, 2025. The company said enrollment has accelerated and remains on track for trial completion in early 2026. The release notes a hybrid recruitment approach: 25% of participants were recruited via targeted social-media campaigns and 75% via clinical sites. Interim analyses previously reported by the company showed clinical and statistically significant reductions in agitation. IGC continues to expand U.S. and Canada clinical operations and to focus on data quality and site performance.

Positive

• Enrollment reached 65% of target
• Targeted digital campaigns supplied 25% of enrollees
• Company targeting trial completion in early 2026
• Interim analyses reported statistically significant reductions in agitation

Negative

• None.

Key Figures

CALMA enrollment 65% Phase 2 CALMA trial for agitation in Alzheimer’s disease

Digital recruitment share 25% Participants enrolled via targeted social-media campaigns

Site-based enrollment share 75% Participants enrolled directly through clinical-site efforts

Agitation prevalence over 76% Individuals with Alzheimer’s experiencing agitation symptoms

Market Reality Check

$0.3420 Last Close

Volume Volume 436,199 is roughly in line with the 20-day average 445,550, indicating typical trading activity ahead of this update. normal

Technical Shares at 0.2908 are trading below the 200-day moving average of 0.34 and sit well under the 0.4985 52-week high while above the 0.2525 52-week low.

Peers on Argus

IGC was down 2.38% with several biotech peers also lower (e.g., CASI -3.38%, KLTO -7.95%, LSB -20.62%), while ESLA +2.5% and LTRN +1.58% moved higher, suggesting mixed but broadly risk-off sentiment in parts of the group.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Caregiver book launch	Positive	-2.9%	Publication of Alzheimer’s caregiver-focused book sponsored by IGC.
Nov 25	AI risk-factor model	Positive	-0.4%	MINT-AD AI model advances for Alzheimer’s risk stratification and detection.
Nov 17	Earnings and CALMA update	Negative	-5.0%	Q2 FY2026 results with CALMA >50% enrollment but weaker revenue.
Nov 13	IGC-AD1 patent grant	Positive	-2.7%	USPTO patent covering IGC-AD1 composition for CNS disorders.
Nov 10	Shareholder call notice	Neutral	+4.3%	Announcement of mid-year FY2026 shareholder update call date and access.

Pattern Detected

Recent news around IGC-AD1, AI initiatives, and corporate updates often coincided with modest share price declines, with only the shareholder update call showing a clear positive reaction.

Recent Company History

Over the last few months, IGC has consistently highlighted progress around Alzheimer’s programs and corporate initiatives. On Nov 17, it reported Q2 FY2026 results with CALMA enrollment past 50% and a $2.7 million asset sale, yet shares fell 5.03%. A new patent for IGC-AD1 on Nov 11 and AI-related MINT-AD progress on Nov 25 also saw small negative moves. Even the caregiver book announcement on Dec 2 coincided with a -2.86% reaction. Against this backdrop, today’s 65% enrollment update extends the narrative of steady clinical advancement amid a cautious tape.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-12-03

An effective shelf framework is in place via an amended S-3/A resale registration filed on Dec 3, 2025, covering up to 978,235 existing and option-related shares offered by current security holders. The company is not selling shares or receiving proceeds from these resales but will bear registration expenses, meaning potential secondary supply comes from selling holders rather than new primary issuance.

Market Pulse Summary

This announcement highlights continued execution in the Phase 2 CALMA trial, with patient enrollment reaching 65% and a notable portion of participants recruited via digital campaigns. It builds on prior updates about expanding trial sites and interim analyses showing statistically significant agitation reductions. Investors may watch for full enrollment, final Phase 2 data, and any subsequent regulatory or financing developments as the company advances IGC-AD1 in a competitive Alzheimer’s landscape.

Key Terms

phase 2 medical

"its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

clinical trial medical

"Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

interim analyses medical

"Interim analyses of the Phase 2 trial, previously announced by the Company"

Interim analyses are planned checks of data performed before a study or clinical trial is complete to see how things are going — like looking at a halftime score to decide whether a strategy is working. For investors, interim results can move a company’s stock quickly because they may indicate early success, safety problems, or lead to faster regulatory decisions or trial changes that affect revenue prospects and risk.

statistically significant medical

"have shown clinical and statistically significant reductions in agitation"

"Statistically significant" means that a result or difference observed in data is unlikely to have occurred by chance alone, suggesting there is a real underlying effect. For investors, it indicates that the findings or patterns they see are likely meaningful and not just random noise, helping them make more informed decisions based on reliable information. Think of it as a pattern that is strong enough to stand out clearly from background randomness.

clinical operations medical

"The Company continues to expand its clinical operations and strengthen site performance"

Clinical operations are the day-to-day work that runs medical trials, including planning studies, enrolling and caring for participants, collecting and verifying data, and ensuring the work follows safety and regulatory rules. For investors, they matter because strong clinical operations keep trials on schedule, control costs and produce reliable results—like a well-managed construction crew that builds on time and to spec, reducing the risk that a promising treatment stalls or fails regulatory review.

AI-generated analysis. Not financial advice.

POTOMAC, MARYLAND / ACCESS Newswire / December 9, 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 it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.

This milestone marks a significant step in advancing IGC-AD1, the Company's proprietary formulation, and demonstrates continued strong momentum toward full enrollment consistent with the goal of completing the trial in early 2026.

Enrollment has accelerated, meaningfully, supported by the Company's data-driven digital recruitment strategy. Approximately 25% of all participants enrolled to date were recruited through IGC Pharma's targeted social-media campaigns, while 75% were enrolled directly through clinical-site efforts.

"Our hybrid recruitment strategy combining site-driven outreach with precision digital campaigns has expanded patient access and accelerated enrollment. We remain focused on completing the trial efficiently, maintaining high data quality, and advancing IGC-AD1 as a potential new therapy for agitation in Alzheimer's disease," said Ram Mukunda, CEO of IGC Pharma.

Agitation is a disruptive and highly prevalent symptom affecting over 76% of individuals living with Alzheimer's disease. Interim analyses of the Phase 2 trial, previously announced by the Company, have shown clinical and statistically significant reductions in agitation, underscoring the therapeutic potential of IGC-AD1. The Company continues to expand its clinical operations and strengthen site performance across the United States and Canada.

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 does IGC's 65% enrollment mean for the Phase 2 CALMA trial (IGC) timeline?

65% enrollment signals accelerated patient recruitment and supports the company's goal to complete the trial in early 2026.

How many participants has IGC recruited via social media for CALMA (IGC)?

The company reported that approximately 25% of enrolled participants to date were recruited through targeted social-media campaigns.

What evidence did IGC disclose about IGC-AD1 efficacy in the Phase 2 CALMA trial?

IGC stated that interim analyses have shown clinical and statistically significant reductions in agitation.

Where is IGC conducting the Phase 2 CALMA trial for IGC-AD1 (IGC)?

The company is expanding clinical operations and running study sites across the United States and Canada.

How has IGC accelerated enrollment for the CALMA trial (IGC)?

IGC attributed faster enrollment to a hybrid recruitment strategy combining site-driven outreach with precision digital campaigns.