IGC Pharma Expands Phase 2 CALMA Trial into Colombia's Premier Alzheimer's Research Center

Rhea-AI Summary

IGC Pharma (NYSE:IGC) expanded its Phase 2 CALMA trial for IGC-AD1 into Colombia by adding Grupo de Neurociencias de Antioquia (GNA), increasing the clinical network to 23 active sites across 26 locations in the US and Canada plus Colombia. CALMA has reached approximately 70% of planned enrollment with completion expected by mid-2026, the operational gating step before database lock and topline results. GNA brings longitudinal cohorts and biomarker expertise; Dr. Claudia Ramos will serve as Principal Investigator, supported by GNA leadership and multidisciplinary teams.

Positive

• Clinical network now spans 23 active sites across 26 locations
• CALMA reached approximately 70% enrollment, advancing toward completion
• Addition of GNA broadens genetic diversity and biomarker expertise
• Expected enrollment completion by mid-2026 ahead of topline results

Negative

• Enrollment at ~70% means trial still incomplete and timeline risk
• Topline results depend on successful mid-2026 database lock and analysis

Key Figures

Enrollment progress: 70% of planned enrollment Active trial sites: 23 active sites Trial locations: 26 locations +1 more

4 metrics

Enrollment progress 70% of planned enrollment Phase 2 CALMA trial for IGC-AD1

Active trial sites 23 active sites CALMA network across U.S. and Canada

Trial locations 26 locations United States and Canada sites for CALMA

Enrollment target timing mid-2026 Expected completion of CALMA Phase 2 enrollment

Market Reality Check

Price: $0.2534 Vol: Volume 432,581 is close t...

normal vol

$0.2534 Last Close

Volume Volume 432,581 is close to the 20-day average 425,849 (relative volume 1.02x). normal

Technical Shares at $0.2504 are trading below the 200-day MA of $0.34 and about 49.77% under the 52-week high.

Peers on Argus

IGC gained 0.81% while momentum data show only ESLA in scan, moving down 11.72%....

1 Down

IGC gained 0.81% while momentum data show only ESLA in scan, moving down 11.72%. Other biotech peers show mixed moves, indicating today’s action is more stock-specific than sector-driven.

Previous Clinical trial Reports

5 past events · Latest: Feb 02 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 02	CALMA enrollment update	Positive	+1.5%	Reported ~70% enrollment and broad Phase 2 site network toward mid-2026 goals.
Jan 22	New NY trial site	Positive	+7.3%	Added Integrative Clinical Trials in Brooklyn to strengthen CALMA enrollment and diversity.
Jan 12	New VA trial site	Positive	-0.1%	Expanded CALMA with Dominion Medical Associates using a hybrid access model.
Jan 05	Capital raise for trial	Negative	+0.6%	Registered direct offering to fund IGC-AD1 Phase 2 and corporate purposes.
Dec 10	Analyst coverage update	Positive	+14.8%	Analyst raised price target citing expectations for positive clinical data and progress.

Pattern Detected

Clinical trial and related catalysts for IGC have often produced modest positive moves, with occasional divergences when site expansions or financing updates did not translate into immediate price strength.

Recent Company History

Over recent months, IGC has repeatedly updated investors on its Phase 2 CALMA trial of IGC-AD1, adding U.S. sites and highlighting progress to about 70% enrollment with roughly 23 active sites across 26 locations and a goal of completing enrollment by mid-2026. Capital was raised in early 2026 to fund Phase 2, and an analyst coverage update in December 2025 emphasized clinical progress as a key driver. Today’s expansion into Colombia fits the ongoing strategy of broadening the trial’s reach and diversity.

Historical Comparison

clinical trial

+4.8 %

Average Historical Move

Historical Analysis

In the past 5 clinical-trial-related updates, IGC saw an average move of about 4.81%, with most positive trial progress triggering modest gains.

Typical Pattern

Same-tag history shows steady advancement of the Phase 2 CALMA program: multiple new U.S. sites, funding to support IGC-AD1 development, and external analyst validation, with today’s update extending the trial into a specialized Colombian Alzheimer’s population.

Regulatory & Risk Context

Active S-3 Shelf · $200,000

Shelf Active

Active S-3 Shelf Registration 2025-12-03

$200,000 registered capacity

An effective resale shelf on Form S-3/A covers up to 978,235 shares held by existing security holders. The company is not selling shares or receiving proceeds from these resales, though it bears registration expenses. A separate prospectus supplement dated January 5, 2026 shows the shelf has been used once via a registered direct offering.

Market Pulse Summary

This announcement extends the Phase 2 CALMA trial into a Colombian center known for genetically link...

Analysis

This announcement extends the Phase 2 CALMA trial into a Colombian center known for genetically linked Alzheimer’s disease, while enrollment has reached about 70% with 23 sites across 26 locations and a goal of completing enrollment by mid-2026. Recent history shows repeated CALMA expansions and dedicated funding for IGC-AD1. Investors may track future updates on enrollment completion, data timing, and any additional use of the existing resale shelf registration and related offerings.

Key Terms

phase 2, randomized, double-blind, placebo-controlled, +2 more

6 terms

phase 2 medical

"expansion of its Phase 2 CALMA trial for IGC-AD1 into Colombia"

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 medical

"CALMA is a randomized, double-blind, placebo-controlled Phase 2 study"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"CALMA is a randomized, double-blind, placebo-controlled Phase 2 study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"CALMA is a randomized, double-blind, placebo-controlled Phase 2 study"

"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.

principal investigator medical

"will serve as Principal Investigator and lead the project"

A principal investigator is the lead person responsible for overseeing a research project or study, ensuring it stays on track and meets its goals. In the context of investments, this role can be likened to the person in charge of a team or initiative, making key decisions and managing resources. Understanding who the principal investigator is can help investors assess the reliability and credibility of a project or research effort.

biomarkers medical

"including longitudinal cohorts and biomarker's research"

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

AI-generated analysis. Not financial advice.

- Adds world renowned GNA site to broaden genetic diversity and strengthen path toward 2026 data catalyst -

POTOMAC, MARYLAND / ACCESS Newswire / February 9, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced the expansion of its Phase 2 CALMA trial for IGC-AD1 into Colombia, South America, through the addition of Grupo de Neurociencias de Antioquia ("GNA").

This expansion marks a pivotal operational milestone as IGC enters a region internationally recognized for its unique, genetically linked Alzheimer's population. The GNA site is the latest addition to a clinical network that now spans 23 active sites across 26 locations in the United States and Canada.

CALMA is a randomized, double-blind, placebo-controlled Phase 2 study that has now reached approximately 70% of planned enrollment. IGC expects to complete enrollment by mid-2026, the primary operational gating step ahead of database lock and topline results.

GNA is internationally recognized for its long-running research into genetically linked Alzheimer's disease and related neurodegenerative conditions, including longitudinal cohorts and biomarker's research. For the Colombia site, Dr. Claudia Ramos, a psychiatrist at GNA with a PhD in Clinical Medicine, will serve as Principal Investigator and lead the project alongside a multidisciplinary team, including Sub-PI and General Coordinator of the GNA Dr. David Aguillón and an experienced group of neuropsychiatrists and medical researchers.

"GNA's deep expertise in longitudinal Alzheimer's cohorts and biomarkers provides us with a high caliber research environment that broadens access to participation, and strengthens the diversity of our clinical program," said Ram Mukunda, CEO of IGC Pharma.

Honoring a global Alzheimer's pioneer.

IGC also recognized the legacy of Dr. Francisco Lopera, founder of GNA and a globally respected Alzheimer's researcher, who passed away in September 2024. "Dr. Lopera's work elevated Alzheimer's research across Latin America and helped reshape the field's understanding of inherited Alzheimer's," Mukunda added. "We are honored to collaborate with the team Dr. Lopera built and inspired, and to advance Alzheimer's research in Colombia with the scientific rigor he championed."

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

How does the addition of GNA affect IGC (NYSE:IGC) CALMA trial enrollment?

It expands site capacity and participant access to genetic cohorts, supporting enrollment momentum. According to the company, GNA adds a Colombian site to a network of 23 active sites across 26 locations, helping reach planned enrollment before the mid-2026 target.

What is the expected timeline for IGC (IGC) CALMA topline results after the Colombia expansion?

Topline results are expected after enrollment completion and database lock, targeted for mid-2026. According to the company, completing enrollment by mid-2026 is the primary gating step ahead of database lock and presentation of topline data.

Who will lead the Colombia site for IGC's CALMA study (IGC-AD1)?

Dr. Claudia Ramos will serve as Principal Investigator for the Colombia site. According to the company, she will lead the project at GNA with support from Sub-PI Dr. David Aguillón and a multidisciplinary team of neuropsychiatrists and researchers.

What proportion of CALMA enrollment has IGC (NYSE:IGC) achieved to date?

The study has reached approximately seventy percent of planned enrollment. According to the company, CALMA is about 70% enrolled, with full enrollment expected by mid-2026 prior to database lock and topline analysis.

Why is GNA's inclusion important for IGC's Phase 2 CALMA trial (IGC)?

GNA contributes longitudinal genetic cohorts and biomarker research that broaden participant diversity. According to the company, GNA's expertise strengthens the scientific environment and access to genetically linked Alzheimer's populations for the CALMA program.

Will the Colombia expansion change the number of active CALMA sites for IGC (IGC)?

Yes; the network now includes the Colombia site alongside existing locations, enhancing geographic coverage. According to the company, CALMA's clinical network totals 23 active sites across 26 locations in the US and Canada, plus the new GNA site in Colombia.