- Strategic Pivot to Pure-Play Biotech -
POTOMAC, MD / ACCESS Newswire / March 19, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced the filing of its Report on Form 10-KT with the U.S. Securities and Exchange Commission ("SEC") for the nine months ended December 31, 2025.
The Company recently changed its fiscal year-end from March 31 to December 31 to better align its reporting with clinical and industry cycles. The current report reflects a nine-month transition period defined by clinical acceleration, the successful divestiture of non-core assets, and international validation of the Company's proprietary AI diagnostic suite.
"We have surpassed 70% enrollment in the Phase 2 CALMA clinical trial, marking a significant acceleration as the program advances toward key development milestones," said Ram Mukunda, CEO of IGC Pharma. "CALMA is evaluating our lead candidate, IGC-AD1, for agitation in Alzheimer's dementia, a critical area of unmet medical need with a massive global footprint. As we move toward full enrollment and a defined clinical readout, our focus remains on disciplined execution and the creation of long-term value for our patients and shareholders."
Strategic & Operational Highlights (nine months ended December 31, 2025)
Clinical Acceleration: Expanded the Phase 2 CALMA trial to key international and domestic sites, driving enrollment past the 70% threshold. IGC-AD1 remains one of the most advanced candidates targeting the neuroinflammation and agitation pathways in Alzheimer's.
Bottom-Line Improvement: Net loss attributable to common stockholders improved by $1.8 million, dropping to $4.1 million for the nine-month period, compared to $5.9 million in the prior-year period.
AI Leadership & Recognition: The Company's AI team received a prestigious award from the National Institute on Aging (NIA), and was picked as a semi-finalist by the Alzheimer's disease data initiative ("ADDI"), validating the technical clarity and clinical utility of our platforms.
Intellectual Property Expansion:
U.S. Patent No. 12,491,200: Issued for a microdose-based cannabinoid treatment for stuttering and Tourette's Syndrome.
U.S. Patent No. 12,465,589: Issued for the proprietary formulation used in IGC-AD1, providing robust protection for the Company's lead asset through its clinical evaluation.
Portfolio Growth: Reported positive in-vitro findings for IGC-1C (targeting tau protein pathways) and IGC-M3 (targeting amyloid aggregation and neuroinflammation), significantly deepening the Company's long-term pipeline.
Asset Optimization: Successfully executed the $2.7 million divestiture of a non-core manufacturing facility, resulting in an approximately $1.1 million non-cash profit and reducing annual operating expenses by approximately $600 thousand.
Financial Summary: Reinvesting for Clinical Success (nine months ended December 31, 2025)
Accelerated R&D Investment: R&D expenses increased 48% to $4.0 million, driven by the expansion of the Phase 2 CALMA trial and the advancement of the IGC-M3 preclinical program.
Significant Bottom-Line Improvement: Net loss attributable to common stockholders improved by $1.8 million, dropping to $4.1 million for the nine-month period, compared to $5.9 million in the prior year.
Operational Efficiency: Despite an increase in non-cash share-based compensation, the Company successfully offset these costs through reductions in depreciation, insurance, and legacy operating expenses following the manufacturing divestiture.
Revenue Transition: Revenue stood at $869 thousand, reflecting a planned transition period as the Company shifted its focus from white-label manufacturing to its core pharmaceutical and AI assets.
FYE 2026 Strategic Catalysts:
As IGC Pharma enters the new fiscal year, management is focused on the following value-driving catalysts:
Finalizing CALMA Enrollment: Completing the final phase of recruitment for the IGC-AD1 trial and preparing for the subsequent clinical readout.
Indication Expansion: Advancing IGC-AD1 to other indications, such as Sleep disturbance in Alzheimer's disease.
Strategic Partnerships: Actively seeking and evaluating collaborations with large biopharmaceutical partners to scale IGC-AD1 and its supporting AI technology.
AI Monetization: Actively planning the commercialization and monetization strategies for the MINT-AD and AHA AI platforms.
Investors and stakeholders may access the filing on www.sec.gov or through the Investor Relations section of IGC Pharma's website at www.investor.igcpharma.com.
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:
Walter Frank / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/igc-pharma-reports-financial-results-and-clinical-progress-for-the-period-ended-decem-1149176
