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IGC Pharma Reaches 70% Enrollment in Phase 2 CALMA Trial Evaluating IGC-AD1 for Alzheimer's Agitation
Accessnewswire· 2026-02-02 13:30
POTOMAC, MARYLAND / ACCESS Newswire / February 2, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today reported it has reached approximately 70% of planned patient enrollment in its Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease. The Company has approximately 23 active sites across 26 locations, and enrollment is progressing across this clinical network. ...
IGC Pharma Expands Phase 2 CALMA Trial with New Clinical Trial Site at Integrative Clinical Trials in New York
Accessnewswire· 2026-01-22 14:00
Core Viewpoint - IGC Pharma, Inc. is enhancing its clinical trial execution and patient diversity for Alzheimer's disease by adding a new clinical site, Integrative Clinical Trials, LLC, to its Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease [1] Group 1: Company Developments - IGC Pharma, Inc. is a clinical-stage pharmaceutical company focused on developing innovative treatments for Alzheimer's disease using Artificial Intelligence [1] - The addition of Integrative Clinical Trials, LLC, located in Brooklyn, New York, as a new clinical site aims to strengthen the trial execution and improve patient diversity [1] Group 2: Clinical Trial Information - The Phase 2 CALMA clinical trial is specifically evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease [1] - Integrative Clinical Trials, LLC conducts studies across a broad range of Central Nervous System disorders, including Alzheimer's disease and mild cognitive impairment [1]
IGC Pharma Aligns Fiscal Year with Calendar Year to Enhance U.S. Investor Transparency and Comparability
Accessnewswire· 2026-01-06 13:00
POTOMAC, MD / ACCESS Newswire / January 6, 2026 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage pharmaceutical company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced that its Board of Directors has approved a change in the Company's fiscal year end from March 31 to December 31, effective December 31, 2025. "This is a straightforward but important step in strengthening how we engage with U.S. i ...
IGC Pharma Raises Capital to Advance IGC-AD1 Phase 2 Trial
Accessnewswire· 2026-01-05 14:00
- New Financing Supports Disciplined Clinical Execution and Value Creation in Alzheimer's Drug Development - POTOMAC, MARYLAND / ACCESS Newswire / January 5, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced that it has entered into a Subscription Agreement (the "2025 SA") with a group of investors for the purchase and sale of an aggr ...
IGC Pharma Secures New U.S. Patent as Pharmaceutical Cannabinoids Gain Regulatory Momentum
Accessnewswire· 2025-12-19 14:00
- New Patent Expands IGC Pharma's Pharmaceutical Cannabinoid Portfolio Beyond Alzheimer's Disease - POTOMAC, MD / ACCESS Newswire / December 19, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced that the United States Patent and Trademark Office (USPTO) has officially issued U.S. Patent No. 12,491,200, covering the Company's novel microd ...
IGC Pharma Announces Coverage Report by Ascendiant Capital Markets about the "Reports Q2 results. We believe more positive clinical data and progress in 2025/26 to be strong catalysts for stock.
Accessnewswire· 2025-12-10 14:00
Core Insights - IGC Pharma, Inc. is a clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease using Artificial Intelligence (AI) [1][2] - Ascendiant Capital Markets has issued a coverage report indicating positive clinical data and progress in 2025/26 as strong catalysts for the stock, raising the price target to $4.75 [1] Company Overview - IGC Pharma is leveraging AI to develop treatments for Alzheimer's and metabolic disorders, with its lead asset, IGC-AD1, currently in a Phase 2 trial for agitation in Alzheimer's dementia [2] - The company's pipeline includes TGR-63, which targets amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions [2] - IGC Pharma integrates AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting, supported by a complete patent portfolio [2]
IGC Pharma Reports 65% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial
Accessnewswire· 2025-12-09 14:00
Core Viewpoint - IGC Pharma, Inc. has achieved a significant enrollment milestone of 65% in its Phase 2 CALMA clinical trial for IGC-AD1, aimed at treating agitation in Alzheimer's disease, indicating strong progress towards full enrollment and completion of the trial by early 2026 [1] Company Summary - IGC Pharma, Inc. is a clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease using Artificial Intelligence [1] - The proprietary formulation IGC-AD1 is being evaluated in the ongoing clinical trial, which is crucial for the company's development pipeline [1] Industry Context - The advancement in clinical trials for Alzheimer's treatments is critical, given the increasing prevalence of the disease and the need for effective therapies [1]
IGC Pharma(IGC) - 2026 Q2 - Earnings Call Transcript
2025-11-17 17:02
Financial Data and Key Metrics Changes - The company reported a non-cash profit of approximately $1.1 million from the divestment of a non-core manufacturing facility, which eliminated about $600,000 in annual operating expenses [22][23] - The company has renewed its $12 million line of credit and is focused on minimizing dilution while funding its business through selective capital raises [17] Business Line Data and Key Metrics Changes - IGC 81 is currently in a phase two trial, with over 50% enrollment completed, and the company is optimistic about finishing the trial in the first half of next year [4][9] - The CALMA trial has expanded to multiple sites in the U.S. and Canada, with significant acceleration in patient recruitment, increasing from four patients a month to 14 [35][36] Market Data and Key Metrics Changes - The company is targeting a significant unmet need in Alzheimer's treatment, with over 55 million diagnosed cases and 400 million individuals at risk due to Alzheimer's pathology [5][16] - The company is developing MINT-AD, an AI-based diagnostic platform aimed at early detection of Alzheimer's, which could help manage the risk for the 400 million individuals at risk [15][16] Company Strategy and Development Direction - The company is focused on advancing its pipeline of drugs, particularly IGC 81, as a disease-modifying therapy, while also developing MINT-AD for early detection of Alzheimer's [6][18] - The strategic divestment of the Vancouver manufacturing facility allows the company to redirect resources and management attention to accelerate the CALMA trial and other small molecule assets [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in completing the CALMA trial and achieving significant milestones in the upcoming year, which they believe will enhance shareholder value [18][42] - The company is insulated from potential regulatory changes affecting the hemp market, as its focus remains on pharmaceutical development and FDA approval [30][31] Other Important Information - The company is in the semi-final round for a $1 million prize for its AI program aimed at advancing Alzheimer's research, with a presentation scheduled for December 5 [17][37] - Management highlighted the importance of non-pharmacological interventions in delaying the onset of dementia, which aligns with their focus on early diagnosis and intervention [16] Q&A Session Summary Question: Will there be another interim data analysis before the trial completion? - Management confirmed that no further interim readouts are expected, focusing instead on completing the trial and the final readout [22] Question: What was the rationale behind the divestment of the Vancouver facility? - The divestment was strategic to eliminate operating expenses, redirect resources, and reduce management burdens while maintaining long-term supply rights for the white label business [22][23] Question: Are there plans for Canadian approval alongside U.S. approval for IGC 81? - Yes, the company plans to seek approval in both the U.S. and Canada, having received approval from Health Canada for the trial [25] Question: Will the new government funding bill impact the phase two trial? - Management stated that the bill targets the consumer hemp market and does not affect the regulatory pathway for prescription drugs like IGC 81 [30][31] Question: How is enrollment going for the CALMA trial? - Enrollment has significantly improved, with a notable increase in patient sign-ups due to effective advertising and geotargeting strategies [35][36] Question: What is the status of the $1 million award for the MINT program? - The company is in the semifinal round and will present its idea for accelerating Alzheimer's research using AI on December 5 [37]
IGC Pharma(IGC) - 2026 Q2 - Earnings Call Transcript
2025-11-17 17:02
Financial Data and Key Metrics Changes - The company reported a non-cash profit of approximately $1.1 million from the divestment of a non-core manufacturing facility, which eliminated about $600,000 in annual operating expenses [22][23] - The company has renewed its $12 million line of credit and is focused on minimizing dilution while funding its business through selective capital raises [17] Business Line Data and Key Metrics Changes - IGC 81 is currently in a phase two trial, with over 50% enrollment completed, and the company is optimistic about finishing the trial in the first half of next year [4][10] - The CALMA trial has expanded to multiple sites in the U.S. and Canada, with a focus on reducing agitation in Alzheimer's patients [10][11] Market Data and Key Metrics Changes - There are over 55 million people worldwide living with Alzheimer's, with an additional 400 million at risk due to prodromal conditions [5] - The company is developing an AI-based diagnostic platform, MINT-AD, aimed at early detection and predicting cognitive decline in individuals at risk for Alzheimer's [14][15] Company Strategy and Development Direction - The company is focused on advancing its pipeline of drugs, particularly IGC 81, as a disease-modifying therapy, while also developing MINT-AD for early detection of Alzheimer's [18] - The strategic divestment of the Vancouver manufacturing facility allows the company to redirect resources towards accelerating the CALMA trial and advancing other small molecule assets [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in completing the CALMA trial and achieving significant milestones in the upcoming year, which they believe will enhance shareholder value [18][31] - The company is not expecting any impact from recent legislation affecting the hemp industry on its pharmaceutical development and FDA approval processes [25][26] Other Important Information - The company is in the semi-final round for a $1 million prize aimed at advancing Alzheimer's research through AI, with a presentation scheduled for December 5 [30] - The company has received recognition for its work, including awards from the National Institute on Aging, highlighting its commitment to Alzheimer's research [30] Q&A Session Summary Question: Will there be another interim data analysis before the CALMA trial completion? - Management does not expect another readout and is focused on completing the trial and the final readout [21][22] Question: What was the rationale behind the divestment of the Vancouver manufacturing facility? - The divestment eliminated $600,000 in annual operating expenses, redirected resources to the CALMA trial, and secured long-term supply rights for the white label business [22][23] Question: Are there plans for Canadian approval in parallel with FDA approval for IGC 81? - Yes, the company plans to seek approval in both the U.S. and Canada as the trial is being conducted in both regions [24] Question: Will the recent government funding bill impact the phase two trial? - Management does not expect any impact as the trial is under rigorous regulatory oversight and focuses on pharmaceutical development, not the consumer hemp market [25][26] Question: How is enrollment going for the CALMA trial? - Enrollment has significantly increased, with a rise from four patients a month to 14, aided by online advertising and geotargeting [28][29]
IGC Pharma(IGC) - 2026 Q2 - Earnings Call Transcript
2025-11-17 17:00
Financial Data and Key Metrics Changes - The company reported a non-cash profit of approximately $1.1 million from the divestiture of a non-core manufacturing facility, which was sold for about $2.7 million [20][21] - The company has renewed its $12 million line of credit and is focused on minimizing dilution while maintaining a clean capital table [17] Business Line Data and Key Metrics Changes - IGC 81 is currently in a phase two trial, with over 50% enrollment completed, and the company is optimistic about finishing the trial in the first half of next year [4][9] - The CALMA trial, which focuses on agitation in Alzheimer's patients, has expanded to multiple sites in the U.S. and Canada, with a significant increase in patient recruitment [10][28] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in the Alzheimer's market, with over 55 million diagnosed patients and 400 million at risk due to Alzheimer's pathology [5][16] - The company is developing an AI-based diagnostic platform, MINT-AD, aimed at early detection and prediction of cognitive decline in Alzheimer's patients [13][14] Company Strategy and Development Direction - The company is focused on advancing its multi-asset pipeline, particularly IGC 81, which is seen as a near-term opportunity to drive shareholder value [6][12] - The strategic divestiture of the Vancouver manufacturing facility allows the company to redirect resources and management attention towards accelerating the CALMA trial and advancing other small molecule assets [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in completing the CALMA trial and achieving significant milestones in the upcoming year, which they believe will enhance shareholder value [18][31] - The company is not expecting any impact from recent legislation affecting the hemp industry on its pharmaceutical development and FDA approval processes [24][25] Other Important Information - The company is in the semi-final round for a $1 million prize aimed at advancing Alzheimer's research through AI, with a presentation scheduled for December 5 [29][31] - The company has received recognition for its work, including awards from the National Institute on Aging, highlighting its commitment to Alzheimer's research [29] Q&A Session Summary Question: Will there be another interim data analysis before the trial completion? - Management indicated that they do not expect another readout and are focused on completing the trial and the final readout [20] Question: Why was the Vancouver manufacturing facility divested? - The divestiture was strategic to eliminate $600,000 in annual operating expenses and redirect resources to accelerate the CALMA trial [20][21] Question: Are there plans for Canadian approval alongside FDA approval? - Yes, the company plans to seek approval in both the U.S. and Canada as the trial is being conducted in both regions [23] Question: Will the recent government funding bill impact the phase two trial? - Management clarified that the bill targets the consumer hemp market and does not affect the regulatory pathway for prescription drugs like IGC 81 [24][25] Question: How is enrollment going for the CALMA trial? - Enrollment has significantly increased, with a rise from signing up four patients a month to 14, aided by online advertising and geotargeting [28]