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- Continued Advancement of CALMA Phase 2 Trial -
POTOMAC, MD / ACCESS Newswire / May 19, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics and artificial intelligence ("AI-enabled") tools for Alzheimer's disease ("AD"), today announced the filing of its Quarterly Report on Form 10-Q with the U.S. Securities and Exchange Commission ("SEC") for the quarter ended March 31, 2026.
"During the first quarter, we continued to execute against our core priorities by advancing CALMA, expanding our clinical site network, and strengthening the AI and intellectual property components of our Alzheimer's strategy with disciplined capital allocation," said Ram Mukunda, CEO of IGC Pharma. "Our near-term focus remains on completing CALMA and deploying capital toward programs that we believe may support long-term value creation for patients and shareholders. As with all clinical-stage programs, there can be no assurance regarding trial timing, clinical outcomes, regulatory approval, or commercialization."
Clinical & Strategic Highlights (three months ended March 31, 2026)
CALMA Clinical Progress: Continued advancement of the Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease. The CALMA trial remains ongoing, with a target enrollment of 146 patients. Subsequent to March 2026, the Company reported approximately 80% patient enrollment in the Phase 2 CALMA clinical trial.
Clinical Site Expansion: Added clinical research sites to the CALMA trial, including Dominion Medical Associates, Inc. within Lightship's site network, Integrative Clinical Trials, LLC in Brooklyn, New York, and Visionary Investigators Network ("VIN").
AHA Intellectual Property: Filed utility patent applications covering the architectural framework of AHA, the Company's internally developed AI-based data harmonization system.
IGC-AD1 Intellectual Property: Announced that the Canadian Intellectual Property Office ("CIPO") issued a Notice of Allowance covering the proprietary composition underlying IGC-AD1, the Company's Phase 2 clinical-stage program for agitation associated with AD.
Financial Summary: Focused Investment in Clinical and AI Execution (three months ended March 31, 2026)
Accelerated Research and Development ("R&D"): R&D expenses were approximately $1.3 million, compared to approximately $997 thousand in the prior-year period. The increase was primarily attributable to the progression of the CALMA trial for IGC-AD1.
Revenue: Revenue was $317 thousand for the three months ended March 31, 2026, compared to $330 thousand for the three months ended March 31, 2025. Revenue in both quarters was primarily derived from the Company's Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others.
Selling, General and Administrative Expenses ("SG&A"): SG&A expenses were approximately $1.2 million, compared to approximately $570 thousand in the prior-year period. The increase was primarily attributable to the absence of a $700 thousand credit recognized in the prior-year period related to the conversion of accrued cash bonuses into performance-based compensation by the Board of Directors, partially offset by decreases in certain operating expenses.
Net Loss: Net loss attributable to common stockholders was approximately $2.4 million for the three months ended March 31, 2026, compared to $1.2 million for the three months ended March 31, 2025. Basic and diluted net loss per share was $0.02 for both periods.
Liquidity and Capital Resources: As of March 31, 2026, the Company had total outstanding debt of approximately $917 thousand. Subsequent to the quarter, the Company raised additional debt of approximately $585 thousand. The Company also maintained access to an undrawn $12 million O-Bank credit facility, subject to its terms and conditions. The Company continues to evaluate financing alternatives, including potential equity and debt transactions, to support its clinical development programs and operations.
Investors and stakeholders may access the filing at 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 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 within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.
Contact Information:
Andres Sanchez
Investor Relations
info@igcpharma.com
+1 301-983-0998 / +1 (202) 569-2566
SOURCE: IGC Pharma, Inc.
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