IGC Pharma discloses updated CALMA Phase 2 data in investor presentation

IGC Pharma, Inc. filed an 8-K on July 13, 2026 disclosing that it had furnished an updated investor presentation to the SEC as Exhibit 99.1, incorporated into the current report.¹

The presentation centers on IGC-AD1, an investigational oral liquid therapy for agitation in Alzheimer's dementia, being tested in the multicenter "CALMA" Phase 2 trial. The company said the trial targets 146 participants, with more than 80% having completed dosing, and a previously reported interim analysis showing a reduction in agitation at 2 weeks.¹

Blinded pooled data covering both treatment arms showed an LS mean change from baseline in CMAI score of -13.6 at week 2 and -14.9 at week 6, in a group of 107 participants.¹ The company cautioned that this pooled dataset mixes IGC-AD1 and placebo participants together, so it cannot show whether the drug itself is working.¹

A smaller interim analysis of 26 participants compared IGC-AD1 to brexpiprazole, marketed as Rexulti, described by the company as the current standard of care for treating agitation in Alzheimer's disease.¹ The company said IGC-AD1 showed numerically earlier and larger changes than those reported in selected published brexpiprazole studies, though this was not a direct head-to-head comparison.¹ The same interim group also showed improvement in sleep disturbance, with reductions of 71% at week 2 (p=0.012) and 78% at end of trial (p=0.02).¹

The filing repeatedly stressed that all data described are preliminary, are not statistically powered for efficacy, and that IGC-AD1 remains an investigational product that has not received approval from the FDA or any other regulator.¹ The company also noted there is no assurance that the CALMA trial will succeed or that any resulting stock valuation would match scenarios described in the presentation.¹