IGC Pharma Secures North American Composition Protection for IGC-AD1 as Phase 2 CALMA Enrollment Advances

Rhea-AI Summary

IGC Pharma (NYSE American: IGC) announced that the Canadian Intellectual Property Office issued a Notice of Allowance for patent No. 3,095,729, securing composition protection for IGC-AD1 across key North American jurisdictions.

IGC said the allowance covers the low-dose THC combination formulation as the Phase 2 CALMA trial approaches enrollment completion (≈70% enrolled).

Positive

• Composition patent allowance granted in Canada for IGC-AD1
• CALMA enrollment ~70% complete
• North American composition protection strengthens exclusivity

Negative

• Patent allowance currently limited to Canada (no explicit U.S. grant yet)
• No new clinical efficacy or safety data disclosed with enrollment update

Key Figures

Trial phase: Phase 2 Enrollment progress: 70% of planned enrollment Patent number: 3,095,729

3 metrics

Trial phase Phase 2 CALMA trial for agitation in Alzheimer’s disease

Enrollment progress 70% of planned enrollment Ongoing randomized, double-blind, placebo-controlled Phase 2 CALMA trial

Patent number 3,095,729 Canadian Notice of Allowance for CNS disorders composition protection

Market Reality Check

Price: $0.2560 Vol: Volume 215,724 is about 0...

low vol

$0.2560 Last Close

Volume Volume 215,724 is about 0.51x the 20-day average of 424,959, indicating muted trading ahead of the announcement. low

Technical At $0.256, shares trade below the 200-day MA of $0.34 and well under the $0.4985 52-week high.

Peers on Argus

IGC was flat on the day, while peers showed mixed moves, from +8.82% (CASI) to -...

IGC was flat on the day, while peers showed mixed moves, from +8.82% (CASI) to -20.62% (LSB), suggesting this update is stock-specific rather than a coordinated sector move.

Previous Clinical trial Reports

5 past events · Latest: Feb 09 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 09	Trial expansion	Positive	+1.2%	CALMA expanded into Colombia, boosting sites and reinforcing 70% enrollment progress.
Feb 02	Enrollment update	Positive	+1.5%	Company reported reaching about 70% enrollment in Phase 2 CALMA trial.
Jan 22	New trial site	Positive	+7.3%	New Brooklyn trial site added to CALMA to aid enrollment and data quality.
Jan 12	New trial site	Positive	-0.1%	Richmond site addition using hybrid access model to expand participant reach.
Jan 05	Capital raise	Positive	+0.6%	Registered direct offering to fund IGC-AD1 Phase 2 clinical development.

Pattern Detected

Clinical-trial updates for IGC-AD1 have usually led to modest positive moves, with an average reaction of about 2.1% and only one slight negative divergence in recent similar announcements.

Recent Company History

Over the past months, IGC has repeatedly updated investors on its Phase 2 CALMA trial for IGC-AD1, adding new sites in New York and Virginia and expanding into Colombia while progressing to roughly 70% enrollment and targeting completion by mid-2026. One financing event specifically supported the Phase 2 program. Against this backdrop, the new North American composition protection and reaffirmation of enrollment progress extend the theme of steadily de-risking both execution and intellectual property around IGC-AD1.

Historical Comparison

+2.1% avg move · Past IGC clinical-trial updates for IGC-AD1 averaged moves of about 2.1%. Today’s IP-focused CALMA p...

clinical trial

+2.1%

Average Historical Move clinical trial

Past IGC clinical-trial updates for IGC-AD1 averaged moves of about 2.1%. Today’s IP-focused CALMA progress news fits the pattern of incremental derisking rather than step-change catalysts.

Recent same-tag events show steady Phase 2 CALMA execution: new US and Colombian sites, enrollment advancing to roughly 70%, and a targeted capital raise to fund the program, now complemented by strengthened composition protection.

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 registration from Dec 3, 2025 covers up to 978,235 shares held by existing security holders. The company is not selling shares under this shelf and does not receive proceeds, though a related shelf has been used once via a 424B5 prospectus on Jan 5, 2026 for a direct offering of 779,997 shares at $0.30.

Market Pulse Summary

This announcement highlights two key developments: a Canadian Notice of Allowance that secures compo...

Analysis

This announcement highlights two key developments: a Canadian Notice of Allowance that secures composition protection for IGC-AD1 across key North American jurisdictions, and confirmation that the Phase 2 CALMA trial has reached about 70% of planned enrollment. In recent months, IGC has expanded trial sites and raised targeted capital to support this program. Investors may watch for enrollment completion, database lock, and any further use of registered securities as the trial advances.

Key Terms

notice of allowance, cns disorders, randomized, double-blind, placebo-controlled, tetrahydrocannabinol (thc), +2 more

6 terms

notice of allowance regulatory

"the Canadian Intellectual Property Office ("CIPO") has issued a Notice of Allowance"

A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.

cns disorders medical

"patent No. 3,095,729, titled "Method and Composition for Treating CNS Disorders""

CNS disorders are illnesses that affect the brain and spinal cord, the body's main control center for movement, thinking, mood and basic bodily functions. They matter to investors because developing safe, effective treatments is often scientifically and legally challenging, making drug candidates high-risk but potentially high-reward—like backing a company trying to repair a malfunctioning central computer that controls an entire system.

randomized, double-blind, placebo-controlled medical

"the ongoing randomized, double-blind, placebo-controlled Phase 2 CALMA trial"

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.

tetrahydrocannabinol (thc) medical

"uses low doses of tetrahydrocannabinol (THC) combined with other ingredients"

Tetrahydrocannabinol (THC) is the main compound in cannabis that produces the drug’s intoxicating “high” by acting on receptors in the brain and body. It matters to investors because THC determines product demand, medical uses, testing requirements and legal limits—like the engine in a car that both drives performance and shapes safety and regulation—so changes in science, rules or consumer tastes directly affect companies and market value.

cannabinoid-based therapeutics medical

"as regulatory frameworks for cannabinoid-based therapeutics continue to evolve"

Medicines and medical products that are derived from or mimic compounds found in the cannabis plant, developed to treat symptoms or diseases through controlled dosing and delivery. Investors care because these therapeutics sit at the intersection of health care and a shifting regulatory and consumer landscape, so clinical results, approval decisions, and manufacturing scalability can quickly affect a company’s sales and growth potential—think of them as new recipes where successful trials and legal approval unlock market access.

database lock technical

"advances towards enrollment completion and subsequent database lock"

A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.

AI-generated analysis. Not financial advice.

POTOMAC, MD / ACCESS Newswire / February 17, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today announced that the Canadian Intellectual Property Office ("CIPO") has issued a Notice of Allowance covering the proprietary composition underlying IGC-AD1, the Company's Phase 2 clinical stage program for agitation associated with Alzheimer's disease.

With this allowance, patent No. 3,095,729, titled "Method and Composition for Treating CNS Disorders", IGC has secured composition protection for IGC-AD1 across key North American jurisdictions, reinforcing the long-term exclusivity around the formulation as the Phase 2 CALMA trial advances toward enrollment completion. The protection covers the specific low-dose combination central to IGC-AD1's therapeutic strategy.

The Company recently reported that approximately 70% of the planned enrollment in the ongoing randomized, double-blind, placebo-controlled Phase 2 CALMA trial has been completed. The Company believes that strengthening composition protection at this stage enhances both the durability and commercial positioning of IGC-AD1 as the program advances towards enrollment completion and subsequent database lock.

"Securing composition protection across North America strengthens the strategic foundation of IGC-AD1 at an important stage of clinical development," said Ram Mukunda, CEO of IGC Pharma. "As CALMA progresses toward its final enrollment phase, expanding patent coverage enhances both the durability and long-term commercial positioning of our Alzheimer's program and supports its potential commercial differentiation."

IGC-AD1 is a proprietary formulation that uses low doses of tetrahydrocannabinol (THC) combined with other ingredients. The Company believes that the multi-target formulation is differentiated from single-target therapeutic approaches as regulatory frameworks for cannabinoid-based therapeutics continue to evolve.

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 does the CIPO Notice of Allowance mean for IGC (IGC) and IGC-AD1 patent protection?

It means Canada has allowed a composition patent for IGC-AD1, strengthening North American protection. According to the company, patent No. 3,095,729 covers the low-dose THC combination, which the company says bolsters long-term exclusivity and commercial positioning as CALMA advances.

How far along is enrollment in IGC's Phase 2 CALMA trial for IGC-AD1 (IGC)?

Approximately 70% of planned enrollment in the randomized Phase 2 CALMA trial is complete. According to the company, CALMA remains double-blind and placebo-controlled and is progressing toward final enrollment and subsequent database lock.

Will the Canadian patent allowance immediately protect IGC-AD1 commercial rights in the U.S. for IGC (IGC)?

No, the allowance secures Canadian composition protection but is not an immediate U.S. patent grant. According to the company, it reinforces North American exclusivity while additional jurisdictional patents or grants would be required for U.S. enforcement.

What is IGC-AD1 and how is it different from single-target Alzheimer's treatments for IGC (IGC)?

IGC-AD1 is a proprietary low-dose THC combination formulation targeting agitation in Alzheimer's disease. According to the company, the multi-target approach is positioned as differentiated from single-target therapeutics amid evolving cannabinoid regulatory frameworks.

How could the patent allowance affect IGC's commercialization strategy for IGC-AD1 (IGC)?

The allowance may enhance commercial defensibility and potential market positioning for IGC-AD1. According to the company, composition protection across North America strengthens durability and supports differentiation as CALMA advances toward enrollment completion.

Does the press release report any new clinical efficacy results for IGC-AD1 from IGC (IGC)?

No new efficacy or safety results were reported; the update focused on patent allowance and enrollment progress. According to the company, the primary clinical milestone referenced is that ≈70% of planned CALMA enrollment is complete.