IGC Pharma reached its previously disclosed 146-patient randomized enrollment target for the Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer’s disease, moving the clinical program closer to database lock, site closeout, and eventual topline analysis.
All 146 targeted participants had been randomized at baseline by the end of Q2 2026. The trial remains ongoing, with limited over-enrollment and patient follow-up continuing as IGC seeks to mitigate potential attrition before completing the study.
CALMA is a randomized, double-blind, placebo-controlled Phase 2 study evaluating IGC-AD1 for agitation in patients with dementia due to Alzheimer’s disease. Reaching the enrollment target shifts the program’s emphasis from patient recruitment to completing follow-up and preparing the clinical database for analysis.
The clinical milestone comes as IGC increasingly concentrates its resources on Alzheimer’s programs. Q2 revenue declined to approximately $265,000 from $328,000, with the company explaining that its core focus is advancing IGC-AD1, completing the Phase 2 study and developing its MINT-AD platform for Alzheimer’s disease.
That investment contributed to a larger quarterly loss. Q2 R&D spending increased 63% to approximately $1.4 million from $851,000, primarily because of the Phase 2 IGC-AD1 program and preclinical work on TGR-63. Net loss widened to approximately $2.94 million from $1.60 million.
IGC is also building technology around its clinical-development strategy. As of June 30, it had capitalized approximately $1.8 million of software-development costs associated with three platforms, including MINT-AD, an AI-driven Alzheimer’s cognitive-decline risk-stratification and treatment-personalization system, and AHA, an internal platform supporting MINT-AD’s data processing and analytics. All three remain in development.
Liquidity remains an important consideration as CALMA advances. IGC had approximately $331,000 of cash and equivalents and a $2 million working-capital deficit at June 30. The company said anticipated financing and potential availability under a $12 million revolving working-capital facility are expected to support operations for at least 12 months, although the facility has borrowing conditions and monthly draw limitations.
The next major clinical milestone will be the transition from completed enrollment and follow-up into locked data and topline analysis, which will provide the first controlled Phase 2 assessment of whether IGC-AD1 can meaningfully reduce agitation in this Alzheimer’s population.
