IGC Pharma Reaches 70% Enrollment in Phase 2 CALMA Trial Evaluating IGC-AD1 for Alzheimer's Agitation

IGC Pharma (NYSE:IGC) reported reaching approximately 70% enrollment in its Phase 2 CALMA trial of IGC-AD1 for agitation associated with Alzheimer’s disease.

Rhea-AI Summary

IGC Pharma (NYSE:IGC) reported reaching approximately 70% enrollment in its Phase 2 CALMA trial of IGC-AD1 for agitation associated with Alzheimer’s disease. The company has about 23 active sites across 26 locations and expects to complete enrollment by mid-2026, moving toward database lock and topline results.

IGC said enrollment uses a hybrid decentralized model to expand patient access; efficacy outcomes are not analyzed ongoing to preserve blinding and trial integrity.

Positive

• Enrollment 70% of planned patients reached
• 23 active sites operating across 26 locations
• Company projects enrollment completion by mid-2026
• Hybrid decentralized model expands patient access and site reach

Negative

• Approximately 30% of enrollment remains, delaying database lock until mid-2026
• IGC-AD1 remains investigational; safety and efficacy not yet established

Argus Feb 2 session

+1.52% close to close Open Argus

Details

News Market Reaction – IGC

In the Feb 2 session, IGC gained 1.52%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement marks further execution on the CALMA Phase 2 trial, moving from 65% enrollment in ...

Analysis

This announcement marks further execution on the CALMA Phase 2 trial, moving from 65% enrollment in late 2025 to roughly 70% with about 23 active sites across 26 locations. Recent history shows added U.S. trial sites and a 779,997-share capital raise at $0.30 to fund development. Investors may track future updates on full enrollment, database lock, and topline results, alongside financial filings that detail cash levels, losses, and any additional use of the resale shelf.

Key Figures

Enrollment progress: 70% of planned patients Active clinical sites: 23 sites Trial locations: 26 locations +5 more

Enrollment progress

70% of planned patients

Phase 2 CALMA trial for agitation in Alzheimer’s disease

Active clinical sites

23 sites

CALMA trial network across 26 locations

Trial locations

26 locations

Geographic footprint for CALMA Phase 2 enrollment

Shares offered

779,997 shares

Registered direct offering on Jan 5, 2026

Offering price

$0.30 per share

Registered direct offering to fund clinical development

Gross proceeds

$234,000

Capital raise to support IGC-AD1 Phase 2 program

Quarterly revenue

$191 thousand

Revenue for quarter ended Sep 30, 2025 (10-Q)

Net loss

$1.821 million

Net loss for quarter ended Sep 30, 2025 (10-Q)

Previous Clinical trial Reports

5 past events · Latest: Jan 22

Same Type 5 events

1. Jan 22

   Site expansion

   24h Move

   +7.3%

   New Brooklyn trial site added to support CALMA enrollment and diversity.

2. Jan 12

   Site expansion

   24h Move

   -0.1%

   Richmond Lightship network site added, using hybrid access model for CALMA.

3. Jan 05

   Capital raise

   24h Move

   +0.6%

   Registered direct offering to fund IGC-AD1 Phase 2 clinical development.

4. Dec 10

   Analyst coverage

   24h Move

   +14.8%

   Analyst raised price target after Q2, citing clinical progress catalysts.

5. Dec 09

   Enrollment milestone

   24h Move

   +2.5%

   Reported 65% enrollment in CALMA trial with accelerating recruitment trends.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2, randomized, double-blind, placebo-controlled, placebo-controlled, restricted stock units, +4 more

8 terms

phase 2 medical

"reached approximately 70% of planned patient enrollment in its Phase 2 CALMA clinical trial"

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.

randomized, double-blind, placebo-controlled medical

"In a randomized, double-blind, placebo-controlled study, efficacy outcomes are not analyzed"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

placebo-controlled medical

"randomized, double-blind, placebo-controlled clinical trial designed to assess safety and efficacy"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

restricted stock units financial

"director Richard K. Prins exercised 100,000 restricted stock units, which were granted"

Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.

shelf registration statement regulatory

"offering is being made under an effective Form S-3 shelf registration statement"

A shelf registration statement is a document a company files with regulators that allows it to sell shares or bonds quickly when it’s a good time to raise money. It’s like having a pre-approved plan ready so the company can act fast without going through lengthy paperwork each time they want to sell, making fundraising more flexible.

form s-3 regulatory

"effective shelf registration on Form S-3 (File No. 333-276330) declared effective"

Form S-3 is a legal document companies use to register their stock sales with the government, making it easier and faster for them to raise money by selling shares to investors. It’s like having a pre-approved shopping list that lets a company quickly sell new shares when they need funds, without going through a lengthy approval process each time.

prospectus supplement regulatory

"and a related prospectus supplement dated January 5, 2026"

A prospectus supplement is an additional document provided alongside a company's main offering details, offering updated or extra information about a specific financial product being sold. It helps investors understand the latest terms, risks, and details of the investment, similar to how an update or revision clarifies or expands on original instructions, ensuring they have current and complete information before making a decision.

credit facility financial

"The company amended and extended its $12 million credit facility, reducing"

A credit facility is a flexible loan arrangement that allows a borrower to access funds up to a set limit whenever needed, similar to a company having an overdraft option on a bank account. It matters to investors because it indicates how easily a business can secure cash when required, affecting its ability to manage expenses, invest, or respond to financial challenges.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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POTOMAC, MARYLAND / ACCESS Newswire / February 2, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today reported it has reached approximately 70% of planned patient enrollment in its Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease.

The Company has approximately 23 active sites across 26 locations, and enrollment is progressing across this clinical network. IGC expects to complete enrollment by mid-2026. The Company believes this milestone meaningfully reduces the primary operational risk for the trial and positions CALMA to progress toward database lock and topline results.

"Reaching ~70% enrollment reflects improving execution and site productivity across our network," said Ram Mukunda, CEO of IGC Pharma. "Enrollment is the final operational gate, and our focus is straightforward: complete enrollment efficiently while maintaining data quality and rigorous trial conduct."

Operational Updates

The Company has continued to activate experienced sites and expand patient access through a hybrid, decentralized model in select geographies. IGC expects enrollment progress to continue as additional site capacity comes online, and newly activated sites ramp to steady-state contribution. In a randomized, double-blind, placebo-controlled study, efficacy outcomes are not analyzed on an ongoing interim basis to preserve blinding and trial integrity.

IGC-AD1 is an investigational, cannabinoid-based therapy being evaluated in a randomized, double-blind, placebo-controlled clinical trial designed to assess safety and efficacy in agitation associated with Alzheimer's disease.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does IGC Pharma say about reaching 70% enrollment in the Phase 2 CALMA trial (IGC)?

IGC reached about 70% of planned enrollment, a milestone the company says reduces operational risk. According to the company, this positions CALMA to progress toward database lock and topline results as remaining sites ramp.

How many sites and locations are active in IGC's CALMA Phase 2 trial (IGC)?

IGC reports approximately 23 active sites across 26 locations supporting CALMA. According to the company, enrollment is progressing across this clinical network with additional site capacity coming online.

When does IGC expect to complete enrollment for the CALMA trial (IGC)?

IGC expects to complete enrollment by mid-2026, the company said. Continued site activations and ramping of newly activated sites are cited as drivers of the projected timeline.

What is IGC-AD1 and what trial design is CALMA using (IGC)?

IGC-AD1 is an investigational cannabinoid-based therapy for agitation in Alzheimer’s disease. According to the company, CALMA is randomized, double-blind, and placebo-controlled to assess safety and efficacy.

Will the CALMA trial analyze efficacy outcomes before database lock (IGC)?

No; efficacy outcomes are not analyzed on an ongoing interim basis to preserve blinding. According to the company, this approach maintains trial integrity until database lock and topline analysis.

How does IGC plan to expand patient access for the CALMA trial (IGC)?

IGC uses a hybrid, decentralized model in select geographies to expand patient access. According to the company, this model plus activating experienced sites aims to improve enrollment efficiency and site productivity.