$IGC Pharma Reports Q2 2026 Results as CALMA Alzheimer's Trial Moves Within Six Randomizations of Enrollment Closure
https://www.accessnewswire.com/newsroom/en/bi...mi-1207902
Phase 2 topline readout expected in Q4 2026 following patient follow-up, database lock, and unblinding
POTOMAC, MD / ACCESS Newswire / August 17, 2026 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage biotechnology company developing therapeutics and AI-enabled tools for Alzheimer's disease, today announced financial results for the second quarter ended June 30, 2026, and provided an update on the Company's lead Alzheimer's program, IGC-AD1.
During the second quarter, the Phase 2 CALMA trial of IGC-AD1 reached the Company's previously disclosed 146-patient baseline randomization target. Subsequent to quarter-end, CALMA has continued its final planned over-enrollment phase and is now within six additional randomizations of expected enrollment closure. Patient follow-up, database lock, unblinding, and topline analysis are expected to follow, with topline data anticipated in the fourth quarter of 2026.
"CALMA is now approaching enrollment closure, and our focus is on execution, patient follow-up, data quality, and readiness for topline analysis," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "During the quarter, we reached the original 146-patient randomization target, and subsequent progress has moved the trial within six randomizations of expected enrollment closure. This is an important execution phase for IGC-AD1 as we prepare the CALMA dataset for scientific, regulatory, and strategic evaluation following completion of the Phase 2 trial."
IGC-AD1 is the Company's lead investigational therapeutic candidate for agitation associated with Alzheimer's dementia, a condition that creates significant burden for patients, caregivers, clinicians, and healthcare systems. CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate IGC-AD1 in this population.
Second Quarter and Recent Highlights
CALMA Phase 2 progress: CALMA reached the Company's original 146-patient baseline randomization target during the second quarter and is now within 6 additional randomizations of expected enrollment closure.
Expected Q4 topline readout: Following enrollment closure, the Company expects to complete patient follow-up, database lock, unblinding, and topline analysis, with Phase 2 topline data anticipated in the fourth quarter of 2026.
Management elected equity over cash repayment: On June 30, 2026, IGC Pharma's CEO and Principal Financial Officer agreed to convert approximately $1.15 million of amounts owed by the Company to them, including funds previously loaned to the Company, into 4,274,853 shares of common stock at $0.27 per share, rather than receive cash repayment. The shares issued or issuable in the transaction are expected to be restricted securities subject to applicable holding-period and resale limitations under Rule 144, further aligning management with shareholders as CALMA approaches expected enrollment closure and Q4 2026 topline data. The transaction reduced outstanding obligations, preserved cash, and increased stockholders' equity.
Psilocybin authorization: IGC Pharma received authorization in Colombia to synthesize, formulate, and conduct development activities involving psilocybin at its Bogotá research and development facility. The authorization provides the Company with a regulated capability to evaluate potential applications of psilocybin in neuropsychiatric symptoms associated with dementia, including depression and anxiety. Further regulatory approvals would be required before initiating any clinical trials involving psilocybin.
Regulatory and data-readiness activities: IGC Pharma continues strengthening regulatory, biostatistical, AI-enabled data science, and strategic pharmaceutical development capabilities to support clinical data review, data quality activities, regulatory preparedness, and potential strategic evaluation following completion of CALMA.
AI-enabled platforms: The Company continued development of AHA, its Agentic Harmonization Assistant for Alzheimer's and aging-related data harmonization, and MINT-AD, its platform for Alzheimer's risk stratification and longitudinal assessment. AHA and MINT-AD are not approved or cleared as diagnostic or therapeutic products.
Q2 2026 Financial Summary
For the three months ended June 30, 2026, revenue was approximately $265 thousand, compared with approximately $328 thousand for the prior-year quarter. Research and development expenses were approximately $1.4 million, compared with approximately $851 thousand in the prior-year quarter, primarily reflecting continued investment in CALMA and the Company's pharmaceutical development programs. Selling, general and administrative expenses were approximately $1.4 million, compared with approximately $1.2 million in the prior-year quarter. Net loss attributable to common stockholders was approximately $3.0 million, or $0.03 per basic and diluted share, for the three months ended June 30, 2026, compared with approximately $1.6 million, or $0.02 per basic and diluted share, for the prior-year quarter.
Cash and cash equivalents were approximately $331 thousand as of June 30, 2026. During the six months ended June 30, 2026, the Company received approximately $1.1 million of net proceeds from equity issuances and approximately $1.3 million of net proceeds from debt financings. Subsequent to quarter-end, the Company raised approximately $687 thousand in gross proceeds under its at-the-market equity program. The Company's liquidity sources include a $12 million revolving working capital credit facility with O-Bank Co., Ltd., with no outstanding amounts as of June 30, 2026. Management believes existing cash, available financing sources, and the Company's ability to access additional debt and equity financing are sufficient to support operations for at least twelve months from the filing date of the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2026.
https://www.accessnewswire.com/newsroom/en/bi...mi-1207902
Phase 2 topline readout expected in Q4 2026 following patient follow-up, database lock, and unblinding
POTOMAC, MD / ACCESS Newswire / August 17, 2026 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage biotechnology company developing therapeutics and AI-enabled tools for Alzheimer's disease, today announced financial results for the second quarter ended June 30, 2026, and provided an update on the Company's lead Alzheimer's program, IGC-AD1.
During the second quarter, the Phase 2 CALMA trial of IGC-AD1 reached the Company's previously disclosed 146-patient baseline randomization target. Subsequent to quarter-end, CALMA has continued its final planned over-enrollment phase and is now within six additional randomizations of expected enrollment closure. Patient follow-up, database lock, unblinding, and topline analysis are expected to follow, with topline data anticipated in the fourth quarter of 2026.
"CALMA is now approaching enrollment closure, and our focus is on execution, patient follow-up, data quality, and readiness for topline analysis," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "During the quarter, we reached the original 146-patient randomization target, and subsequent progress has moved the trial within six randomizations of expected enrollment closure. This is an important execution phase for IGC-AD1 as we prepare the CALMA dataset for scientific, regulatory, and strategic evaluation following completion of the Phase 2 trial."
IGC-AD1 is the Company's lead investigational therapeutic candidate for agitation associated with Alzheimer's dementia, a condition that creates significant burden for patients, caregivers, clinicians, and healthcare systems. CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate IGC-AD1 in this population.
Second Quarter and Recent Highlights
CALMA Phase 2 progress: CALMA reached the Company's original 146-patient baseline randomization target during the second quarter and is now within 6 additional randomizations of expected enrollment closure.
Expected Q4 topline readout: Following enrollment closure, the Company expects to complete patient follow-up, database lock, unblinding, and topline analysis, with Phase 2 topline data anticipated in the fourth quarter of 2026.
Management elected equity over cash repayment: On June 30, 2026, IGC Pharma's CEO and Principal Financial Officer agreed to convert approximately $1.15 million of amounts owed by the Company to them, including funds previously loaned to the Company, into 4,274,853 shares of common stock at $0.27 per share, rather than receive cash repayment. The shares issued or issuable in the transaction are expected to be restricted securities subject to applicable holding-period and resale limitations under Rule 144, further aligning management with shareholders as CALMA approaches expected enrollment closure and Q4 2026 topline data. The transaction reduced outstanding obligations, preserved cash, and increased stockholders' equity.
Psilocybin authorization: IGC Pharma received authorization in Colombia to synthesize, formulate, and conduct development activities involving psilocybin at its Bogotá research and development facility. The authorization provides the Company with a regulated capability to evaluate potential applications of psilocybin in neuropsychiatric symptoms associated with dementia, including depression and anxiety. Further regulatory approvals would be required before initiating any clinical trials involving psilocybin.
Regulatory and data-readiness activities: IGC Pharma continues strengthening regulatory, biostatistical, AI-enabled data science, and strategic pharmaceutical development capabilities to support clinical data review, data quality activities, regulatory preparedness, and potential strategic evaluation following completion of CALMA.
AI-enabled platforms: The Company continued development of AHA, its Agentic Harmonization Assistant for Alzheimer's and aging-related data harmonization, and MINT-AD, its platform for Alzheimer's risk stratification and longitudinal assessment. AHA and MINT-AD are not approved or cleared as diagnostic or therapeutic products.
Q2 2026 Financial Summary
For the three months ended June 30, 2026, revenue was approximately $265 thousand, compared with approximately $328 thousand for the prior-year quarter. Research and development expenses were approximately $1.4 million, compared with approximately $851 thousand in the prior-year quarter, primarily reflecting continued investment in CALMA and the Company's pharmaceutical development programs. Selling, general and administrative expenses were approximately $1.4 million, compared with approximately $1.2 million in the prior-year quarter. Net loss attributable to common stockholders was approximately $3.0 million, or $0.03 per basic and diluted share, for the three months ended June 30, 2026, compared with approximately $1.6 million, or $0.02 per basic and diluted share, for the prior-year quarter.
Cash and cash equivalents were approximately $331 thousand as of June 30, 2026. During the six months ended June 30, 2026, the Company received approximately $1.1 million of net proceeds from equity issuances and approximately $1.3 million of net proceeds from debt financings. Subsequent to quarter-end, the Company raised approximately $687 thousand in gross proceeds under its at-the-market equity program. The Company's liquidity sources include a $12 million revolving working capital credit facility with O-Bank Co., Ltd., with no outstanding amounts as of June 30, 2026. Management believes existing cash, available financing sources, and the Company's ability to access additional debt and equity financing are sufficient to support operations for at least twelve months from the filing date of the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2026.
