IGC Pharma Adds Visionary Investigators Network as Clinical Site to Phase 2 CALMA Trial

Rhea-AI Summary

IGC Pharma (NYSE:IGC) added Visionary Investigators Network (VIN) as a clinical research site for its Phase 2 CALMA trial of IGC-AD1 to treat agitation associated with Alzheimer's disease dementia. The company reported approximately 70% of planned enrollment is completed.

VIN's Coconut Grove site in Miami will support ongoing enrollment using a practice-integrated model and is led by Dr. Andrew Lerman with a dedicated clinical trial coordinator.

Positive

• Enrollment approximately 70% complete
• Added VIN Coconut Grove clinical site in Miami
• Practice-integrated site model to support efficient enrollment
• Site led by PI with 10+ years and 20+ neurodegenerative trials

Negative

• None.

Key Figures

Enrollment progress: ≈70% of planned enrollment Investigator experience: More than ten years Prior clinical trials: Over 20 trials +5 more

8 metrics

Enrollment progress ≈70% of planned enrollment Phase 2 CALMA trial status recently reported by company

Investigator experience More than ten years Dr. Andrew Lerman’s CNS disorder experience

Prior clinical trials Over 20 trials Neurodegenerative-focused trials where Dr. Lerman served as Principal Investigator

Quarterly revenue $191 thousand Revenue for quarter ended September 30, 2025 (10-Q)

Quarterly net loss $1.821 million Net loss for quarter ended September 30, 2025 (10-Q)

Cash balance $1.105 million Cash and cash equivalents at September 30, 2025 (10-Q)

Credit facility size $12 million Amended and extended credit facility referenced in 10-Q

Registered resale shares 978,235 shares Shares covered by amended S-3/A resale registration

Market Reality Check

Price: $0.2602 Vol: Volume 155,315 is below t...

low vol

$0.2602 Last Close

Volume Volume 155,315 is below the 20-day average of 363,924 (relative volume 0.43), suggesting a muted pre-news setup. low

Technical Shares trade below the 200-day MA of 0.34 with price at 0.2602, reflecting a weak longer-term trend into this update.

Peers on Argus

Momentum data flagged IGC as moving up with 1 peer (KLTO) also up, but other clo...

1 Up

Momentum data flagged IGC as moving up with 1 peer (KLTO) also up, but other close biotech peers show mixed moves and only one peer in the scanner, indicating this looks more stock-specific than a sector-wide rotation.

Previous Clinical trial Reports

5 past events · Latest: Feb 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 17	Patent protection	Positive	+0.0%	North American composition protection for IGC-AD1 as CALMA nears full enrollment.
Feb 09	International site expansion	Positive	+1.2%	CALMA expansion into Colombia via leading Alzheimer’s research center GNA.
Feb 02	Enrollment milestone	Positive	+1.5%	CALMA reaches ≈70% enrollment with 23 active sites across 26 locations.
Jan 22	US site expansion	Positive	+7.3%	New Brooklyn trial site added to strengthen CALMA enrollment and data quality.
Jan 12	US site expansion	Positive	-0.1%	Lightship network site in Virginia added using hybrid access model for CALMA.

Pattern Detected

Clinical-trial CALMA updates have generally led to modest positive price reactions, with most prior site/enrollment announcements aligning positively and only one showing a small negative divergence.

Recent Company History

Over the past six weeks, IGC has repeatedly updated investors on the Phase 2 CALMA trial. On Jan 12 and Jan 22, new U.S. trial sites were added, followed by a broader enrollment milestone at ≈70% on Feb 2. Additional expansion into Colombia was announced on Feb 9, and composition protection for IGC‑AD1 across North America came on Feb 17. Today’s VIN site addition continues this pattern of network expansion and execution-focused CALMA updates.

Historical Comparison

+2.0% avg move · Recent CALMA clinical-trial updates, mostly site additions and enrollment milestones, have produced ...

clinical trial

+2.0%

Average Historical Move clinical trial

Recent CALMA clinical-trial updates, mostly site additions and enrollment milestones, have produced average moves of about 1.98%, framing today’s VIN site news within an ongoing execution story.

IGC has steadily broadened CALMA’s Phase 2 footprint with new U.S. and international sites, reached ≈70% enrollment, and secured composition protection for IGC‑AD1 as it advances toward planned mid‑2026 enrollment completion.

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 S-3/A resale shelf dated 2025-12-03 covers up to 978,235 shares for existing holders, including 588,235 shares issued for $200,000 at $0.34 per share. The company does not sell shares or receive proceeds under this registration but does bear related expenses.

Market Pulse Summary

This announcement adds Visionary Investigators Network as another clinical site in the Phase 2 CALMA...

Analysis

This announcement adds Visionary Investigators Network as another clinical site in the Phase 2 CALMA trial, aiming to bolster enrollment and execution as the study sits at roughly 70% of planned enrollment. Recent history shows a steady cadence of new sites and geographic expansion for CALMA. Investors may watch future updates on enrollment completion, timing to database lock and topline data, and how the company manages financing needs alongside its existing resale shelf structure.

Key Terms

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

6 terms

phase 2 medical

"participating in the Company's Phase 2 CALMA 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.

randomized medical

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

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 clinical trial"

A double blind study is a clinical test design where neither the participants nor the researchers know who receives the experimental treatment versus a control (often a placebo), preventing expectations from influencing results. Like a blind taste test for a new recipe, it helps ensure outcomes reflect the treatment’s real effect rather than people’s hopes or guesswork, making the data more trustworthy for assessing safety, efficacy and commercial prospects.

placebo-controlled medical

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

"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.

cannabinoid-based medical

"IGC-AD1, a proprietary cannabinoid-based investigational therapy, for associated"

Cannabinoid-based describes products, medicines, or technologies built around cannabinoids — chemical compounds originally found in cannabis plants or their synthetic equivalents — as the primary active ingredient. Investors care because these offerings carry specific market opportunities and risks tied to regulation, clinical proof, intellectual property and public acceptance; think of cannabinoids as the key ingredient in a recipe that can drive sales if safe and legal, or limit them if not.

principal investigator medical

"a history of serving as Principal Investigator on over 20 neurodegenerative-focused"

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.

AI-generated analysis. Not financial advice.

- Practice integrated neurology network expands enrollment capacity -

POTOMAC, MARYLAND / ACCESS Newswire / February 23, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today announced the addition of Visionary Investigators Network ("VIN") as a clinical research site participating in the Company's Phase 2 CALMA trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease dementia.

VIN operates clinical research programs embedded within established private neurology practices, providing access to well-characterized patient populations while maintaining continuity of clinical care. IGC Pharma believes this practice-integrated model supports efficient enrollment, sustained patient engagement, and consistent protocol adherence as the CALMA trial advances. The Company recently reported approximately 70% of planned enrollment is completed.

"The CALMA trial continues as designed, and our focus is execution through enrollment completion," said Ram Mukunda, CEO of IGC Pharma. "VIN brings an experienced, practice-integrated research model that aligns well with our Phase 2 execution priorities and supports continued enrollment momentum.

VIN - Coconut Grove location is led by Dr. Andrew Lerman, a neurologist with more than ten years of experience in Central Nervous System disorders and a history of serving as Principal Investigator on over 20 neurodegenerative-focused clinical trials, including studies in Alzheimer's disease and mild cognitive impairment. The CALMA trial will be conducted at VIN's Coconut Grove location in Miami, Florida, supported by Clinical Trial Coordinator Susan Gonzalez.

CALMA is a randomized, double blind, placebo-controlled Phase 2 clinical trial designed to assess the safety and efficacy of IGC-AD1, a proprietary cannabinoid-based investigational therapy, for associated with Alzheimer's disease.

About Visionary Investigators Network:

VIN is a multi-site, neurology-focused clinical research organization operating across South Florida. VIN conducts clinical trials embedded within established private neurology practices, supporting continuity of care while enabling access to well-characterized patient populations.

The network specializes in neurodegenerative and central nervous system disorders, including Alzheimer's disease and related dementias, and is supported by experienced physician investigators, dedicated research teams, and centralized regulatory and quality management infrastructure. VIN operates at multiple sites, but given the research strengths of the Coconut Grove Site, this location was chosen for the development and advancement of the CALMA Program.

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, and on Forms 10-Q filed with the SEC on August 14, 2025, and on November 14, 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 did IGC Pharma announce on February 23, 2026 about the CALMA trial (IGC)?

IGC added Visionary Investigators Network as a clinical site for the Phase 2 CALMA trial. According to the company, this expands enrollment capacity and supports continued enrollment momentum as the trial advances.

How far along is enrollment for IGC's Phase 2 CALMA trial as of February 23, 2026?

Enrollment is reported to be approximately 70% complete. According to the company, that level reflects ongoing recruitment progress and underpins the focus on executing to enrollment completion.

Where will the new VIN clinical site for IGC's CALMA trial be located and operate?

The VIN site will operate at Coconut Grove in Miami, Florida. According to the company, VIN runs research programs embedded in private neurology practices to access well-characterized patient populations.

Who will lead the VIN Coconut Grove site for IGC's CALMA trial (IGC)?

The Coconut Grove site is led by Dr. Andrew Lerman, a neurologist with over ten years' CNS experience. According to the company, he has served as Principal Investigator on more than 20 neurodegenerative trials.

What is the design and objective of the CALMA trial for IGC-AD1 (IGC)?

CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial assessing safety and efficacy of IGC-AD1 for agitation in Alzheimer's disease. According to the company, the trial evaluates a proprietary cannabinoid-based investigational therapy.