Press release·02/14/2025 22:17:49

Overview

IGC Pharma is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer’s disease. The company has a robust pipeline of five assets targeting different aspects of Alzheimer’s, including its lead drug candidate IGC-AD1 which is currently in a Phase 2 clinical trial for agitation in Alzheimer’s dementia.

Key highlights:

• IGC-AD1 has shown promising results in reducing agitation in Alzheimer’s patients much faster than traditional medications, with potential for disease-modifying effects.
• The company is also developing other small molecule assets like TGR-63, IGC-1C, IGC-M3, and LMP to target various hallmarks of Alzheimer’s disease.
• In addition to its drug pipeline, IGC Pharma is leveraging AI and machine learning to develop models for early Alzheimer’s detection and optimize clinical trial design.
• The company controls a portfolio of 30 patent filings to protect its intellectual property.
• IGC Pharma has two business segments - Life Sciences and Infrastructure. The Life Sciences segment focuses on developing and commercializing its Alzheimer’s drug candidates and wellness products, while the Infrastructure segment includes construction contracts and equipment rental.

Life Sciences Segment

The Life Sciences segment is the core focus of IGC Pharma’s business. Key highlights include:

• IGC-AD1, the company’s lead drug candidate, has shown promising results in reducing agitation in Alzheimer’s patients in a Phase 2 trial, with a much faster onset of action compared to existing treatments.
• The company is expanding the clinical development of IGC-AD1 to evaluate its potential as a disease-modifying therapy.
• IGC Pharma has also developed in-house wellness brands that are sold through online channels, providing additional revenue streams.

Infrastructure Segment

The Infrastructure segment has been operating since 2008 and includes:

• Execution of construction contracts
• Rental of heavy construction equipment

Contract Research Organization (CRO) and Clinical Trial Software

IGC Pharma has established an internal CRO with proprietary software to manage its clinical trials more efficiently and cost-effectively compared to using external CROs. The company is also integrating machine learning and AI into the software framework to improve decision-making, data entry, computational models, trial design, and data analysis.

Business Strategy

IGC Pharma’s key business strategies include:

• Developing IGC-AD1 as a drug for treating agitation and potentially Alzheimer’s disease itself, subject to FDA approval and successful clinical trials.
• Advancing the development of other pipeline assets like TGR-63 for Alzheimer’s treatment.
• Driving revenue from in-house over-the-counter (OTC) wellness brands and formulations.
• Allocating capital to enhance shareholder value.

The company believes that developing both symptom-modifying and disease-modifying agents has less risk compared to focusing solely on disease-modifying drugs, which require expensive multi-year trials. However, the potential upside and value creation is significant if IGC Pharma can obtain a first-in-class advantage with any of its drug candidates.

Company Highlights for Q3 2024

Key highlights for the quarter ended December 31, 2024 include:

• Expansion of the clinical research program for IGC-AD1, including new trials to evaluate its potential as a disease-modifying therapy.
• Announcement of additional interim data from the ongoing Phase 2 trial of IGC-AD1.
• Enrollment of patients at the Baycrest Academy for Research and Education in Canada as part of the Phase 2 trial.
• Winning two awards in the PREPARE Challenge for the company’s entry of the Mexican Health and Aging Study (MHAS) database.

Financial Performance

The company’s financial performance for the three and nine months ended December 31, 2024 is summarized below:

Revenue:

• Q3 2024: $257k, up 26% from Q3 2023
• 9M 2024: $941k, down 10% from 9M 2023

Gross Profit:

• Q3 2024: $104k, down 22% from Q3 2023
• 9M 2024: $465k, down 17% from 9M 2023

Operating Loss:

• Q3 2024: $1.9 million, down 37% from Q3 2023
• 9M 2024: $6.0 million, down 21% from 9M 2023

Net Loss:

• Q3 2024: $1.8 million, down 67% from Q3 2023
• 9M 2024: $5.9 million, down 41% from 9M 2023

The decrease in net loss was primarily driven by lower SG&A and R&D expenses, as well as the absence of an impairment loss recorded in the prior year period.

Liquidity and Capital Resources

IGC Pharma has obtained a $12 million working capital credit facility and raised $6 million through share issuances to fund its operations and research & development initiatives. The company continues to evaluate various financing options, including private placements and at-the-market (ATM) offerings, to support its growth.

As of December 31, 2024, the company had $470k in cash and cash equivalents, with a working capital of $394k. Cash used in operating activities was $4.1 million for the nine months ended December 31, 2024.

Overall, IGC Pharma is making progress in advancing its Alzheimer’s drug pipeline, particularly with the promising results for its lead candidate IGC-AD1. The company’s focus on cost management and securing additional financing to support its R&D efforts will be crucial in the coming quarters as it works towards potential regulatory approvals and commercialization.