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IGC Pharma (NYSEAM:IGC) Update / briefing Transcript
2026-02-18 19:02
IGC Pharma (NYSEAM:IGC) Update Summary Company Overview - **Company**: IGC Pharma - **Industry**: Biotechnology, specifically focused on Alzheimer's disease and cannabinoid-based therapies - **Key Personnel**: Ram Mukunda (Chairman and CEO), Ed Woo (Senior Research Analyst at Ascendiant Capital Markets) Core Points and Arguments 1. **Clinical Stage Focus**: IGC Pharma is a clinical stage biotechnology company with a focus on Alzheimer's disease and metabolic disorders, leveraging AI in its research and development efforts [5][7] 2. **Lead Asset**: The lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase II clinical trial (CALMA) targeting agitation associated with Alzheimer's dementia, which affects approximately 50 million people globally [7][35] 3. **Trial Progress**: The CALMA trial is 70% enrolled, with expectations to complete enrollment by mid-2026. The trial aims to address agitation, a symptom present in 76% of Alzheimer's patients [25][26][28] 4. **AI Integration**: IGC Pharma is developing an AI platform (MINT-AD) to stratify risk for Alzheimer's without expensive PET scans, aiming for beta testing in the U.S. within months [11][18][20] 5. **Market Opportunity**: The Alzheimer's market is substantial, with 50 million affected globally. A successful drug for agitation could generate significant revenue, with just 1% market capture equating to $1 billion [35][36] 6. **Differentiation**: IGC-AD1 is expected to act faster than existing treatments, with potential effects observable within 2-3 days, and may also address sleep disturbances in Alzheimer's patients [36][37] 7. **Regulatory Environment**: Recent regulatory changes favor IGC Pharma, including the Mitch McConnell 2026 hemp definition amendment, which could enhance the company's market position and protect its intellectual property [48][49] 8. **Future Trials**: Plans for future trials include investigating the drug's potential for disease modification and cognition improvement, pending completion of a toxicology study [45][46] Additional Important Content 1. **Patient Education**: The company is actively educating potential trial participants about agitation symptoms to improve enrollment, utilizing social media for outreach [29][30] 2. **Global Reach**: IGC Pharma has established connections in various countries, including India and Colombia, to facilitate trials and expand its market presence [22] 3. **Potential Partnerships**: Post-Phase II, the company may seek partnerships or exits, with potential valuations ranging from $750 million to $4 billion depending on interest [41][42] 4. **Broader Applications**: Beyond Alzheimer's, the cannabinoid-based formulation may have applications in other conditions, including pain management and stuttering, with a significant market potential [50][51] This summary encapsulates the key insights from the IGC Pharma update, highlighting the company's strategic focus, market potential, and innovative approaches in addressing Alzheimer's disease and related conditions.
IGC Pharma Expands Phase 2 CALMA Trial into Colombia's Premier Alzheimer's Research Center
Accessnewswire· 2026-02-09 13:30
- Adds world renowned GNA site to broaden genetic diversity and strengthen path toward 2026 data catalyst - POTOMAC, MARYLAND / ACCESS Newswire / February 9, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced the expansion of its Phase 2 CALMA trial for IGC-AD1 into Colombia, South America, through the addition of Grupo de Neurociencias de Antioquia ("GNA"). This expansion marks a pivotal operational milestone as IGC enters a region internationally recognized for its unique ...
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
Core Viewpoint - IGC Pharma has announced a change in its fiscal year end from March 31 to December 31, effective December 31, 2025, to enhance engagement with U.S. investors [1] Company Summary - IGC Pharma is a clinical-stage pharmaceutical company focused on developing innovative treatments for Alzheimer's disease using Artificial Intelligence [1] - The decision to change the fiscal year end is described as a straightforward but important step by the CEO, Ram Mukunda [1]
IGC Pharma Raises Capital to Advance IGC-AD1 Phase 2 Trial
Accessnewswire· 2026-01-05 14:00
Core Insights - IGC Pharma, Inc. has entered into a Subscription Agreement for the sale of 779,997 shares of common stock at a price of $0.30 per share, expecting gross proceeds of approximately $234,000 [1][3] Group 1: Financing and Investment - The financing will support disciplined clinical execution and value creation in the development of Alzheimer's drugs [1] - The company welcomes sophisticated, long-term investors who bring not only capital but also experience and networks to support growth [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used for working capital and general corporate purposes, including funding the Phase 2 clinical development program for IGC-AD1 [3] Group 3: Company Overview - IGC Pharma is a clinical-stage biotechnology company utilizing AI to develop treatments for Alzheimer's and metabolic disorders, with its lead asset IGC-AD1 currently in a Phase 2 trial [5] - The company's pipeline includes TGR-63 targeting amyloid plaques and early-stage programs focused on neurodegeneration and metabolic dysfunctions [5]
IGC Pharma Secures New U.S. Patent as Pharmaceutical Cannabinoids Gain Regulatory Momentum
Accessnewswire· 2025-12-19 14:00
Core Insights - IGC Pharma has received a new patent for a microdose-based cannabinoid treatment targeting stuttering and Tourette's Syndrome, expanding its portfolio beyond Alzheimer's disease [1] Company Developments - The United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,491,200 to IGC Pharma, which covers the novel treatment [1]
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]