POTOMAC, MARYLAND / ACCESS Newswire / June 30, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders, today unveiled the key achievements and advancements that defined Fiscal Year 2025, ended March 31, 2025. This past year has been nothing short of transformative, marked by significant clinical progress, strategic expansion, and growing recognition for our pioneering approach to Alzheimer's disease.
The Company has filed its Annual Report on Form 10-K for the fiscal year ended March 31, 2025 ("FYE 2025"), with the U.S. Securities and Exchange Commission (SEC). The report provides a comprehensive overview of the Company's financial performance, operations, and strategic outlook. Investors and other stakeholders can access the full filing on the SEC's website at www.sec.gov or through the Investor Relations section of IGC Pharma's website at www.investor.igcpharma.com.
"Fiscal Year 2025 stands as a testament to IGC Pharma's unwavering commitment to addressing one of the most pressing global health challenges: Alzheimer's disease," said Ram Mukunda CEO of IGC Pharma. "We have not only advanced our lead asset, IGC-AD1, through critical clinical milestones but have also strategically expanded our reach and solidified our innovative position through AI integration and a growing pipeline. Our progress reflects the dedication of our team, the strength of our scientific foundation, and our relentless pursuit of meaningful solutions for patients and their families. IGC Pharma is not just developing therapies; we are building a future where Alzheimer's is no longer an insurmountable challenge."
Highlights of a Pivotal Year for IGC Pharma:
Positive Interim Data Reinforces IGC-AD1's Potential:
April 2, 2024 - IGC Pharma released positive interim data from its ongoing Phase 2 CALMA trial for agitation in Alzheimer's disease, providing early validation of IGC-AD1's therapeutic promise. The interim data demonstrated a clinical and statistically significant reduction in agitation in patients with Alzheimer's compared to placebo at week 6, with clinical improvements observed as early as week 2. Agitation affects approximately 76% of the estimated 50 million individuals living with Alzheimer's worldwide, yet only one treatment is currently FDA-approved-highlighting a vast unmet medical need and multi-billion-dollar opportunity.
November 14, 2024: Further interim data from the CALMA trial highlighted additional cognitive benefits of IGC-AD1 in Alzheimer's patients, Notably, results showed a reduction in sleep disturbances by approximately 71% at week 2 and 78% at week 6 for those on active medication, suggesting a broader impact beyond agitation. These results underscore the potential of IGC-AD1 as a multifaceted treatment for Alzheimer's symptoms.
Broadening IGC-AD1's Therapeutic Scope: Targeting Underlining Alzheimer's Pathology:
December 2, 2024: The Company announced a pivotal expansion of its clinical research program for IGC-AD1, moving beyond agitation to directly target cognitive impairment and the fundamental pathology of Alzheimer's disease. This strategic expansion includes efforts to evaluate IGC-AD1's potential to reduce amyloid plaques, neurofibrillary tangles, and improve mitochondrial functioning, hallmarks of the disease. This significantly broadens IGC-AD1's potential as a disease-modifying therapy and expands its addressable market, representing a major step forward in our mission to combat Alzheimer's.
May 12, 2025: IGC Pharma presented compelling Genetic Toxicology Safety Data on the API in IGC-AD1 at the 2025 Genetic Toxicology Association Meeting, highlighting the safety profile of our lead compound - a crucial step for regulatory approvals.
Strategic Expansion of Clinical Research Program to Accelerate Enrollment and Broaden Patient Access:
Throughout Fiscal Year 2025, IGC Pharma expanded its network of clinical trial sites for the CALMA trial, adding multiple strategic locations across North America. These expansions included leading research institutions and sites in diverse geographic areas such as Ontario (Canada), Florida, Rhode Island, Puerto Rico, and Oklahoma. This strategic broadening of our clinical trial footprint is designed to accelerate patient enrollment, enhance access to diverse patient populations, and strengthen the overall robustness of our study.
Innovation in Artificial Intelligence and Recognitions:
March 4, 2025 - The Company advanced development on its Multimodal Interpretable Transformer for Alzheimer's disease ("MINT"-AD), its proprietary AI-based diagnostic tool designed to aid in the early detection of Alzheimer's disease and related dementias. The system integrates multimodal data to support earlier intervention, physician decision-making, and personalized risk stratification-addressing a critical unmet need in the Alzheimer's diagnostic pathway.
October 1, 2024: IGC Pharma celebrated winning two awards in the prestigious PREPARE Challenge (Pioneering Research for Early Prediction of Alzheimer's and Related Dementias EUREKA Challenge), showcasing our innovative research capabilities and thought leadership in the field.
Financial Performance and Operational Efficiency:
During Fiscal 2025, the Company's revenue decreased from about $1.3 million in Fiscal 2024 to about $1.2 million in Fiscal 2025. The primary source of revenue in both years was from the Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others. Fiscal 2024, the Company also generated $164 thousand in revenue from the infrastructure business. However, in Fiscal 2025, revenue from Infrastructure was nil due to the strategic shift and the completion of all infrastructure projects. Excluding Infrastructure, revenue from the Life Sciences segment increased from $1,181 thousand in Fiscal 2024 to $1,271 thousand in Fiscal 2025.
The Company reported selling, general, and administrative (SG&A) expenses for Fiscal 2025 at approximately $4.4 million, representing a decrease of approximately $2.3 million, or 35%, compared to the $6.7 million recorded in Fiscal 2024. This significant decline in SG&A expenses is attributable to the Company's focused efforts to optimize corporate-level operational efficiency by lowering employee-related costs due to headcount alignment and compensation restructuring, implementing better inventory management systems, and reducing spending on legal and professional services through more efficient vendor management. In a demonstration of cost and cash discipline, management elected to convert approximately $750 thousand in bonuses into performance-based compensation, payable only upon the achievement of defined business milestones, which also align with shareholder interest.
In Fiscal 2025, the Company reported R&D expenses of approximately $3.7 million, representing a decrease of $118 thousand or 3% compared to approximately $3.8 million in Fiscal 2024. The R&D expenses are primarily attributed to the progression of CALMA trial on IGC-AD1 and pre-clinical studies on TGR-63, indicating the Company's dedication to advancing its product pipeline. We expect to divert more resources to the development of TGR-63 and the CLAMA trial. As such, the Company anticipates an increase in R&D expenses.
Through fiscal 2025, IGC raised about $4.64 million through a combination of private equity placements and at-the-market ("ATM") offering program.
Subsequent to the March 31, 2025, on June 24, 2025, the Company extended its existing loan agreement with O-Bank, Co., Ltd., for one year, on substantially the same terms as previously disclosed on Form 8-K filed on August 2, 2024, with minor modifications to the facility renewal fees and interest rate.
Net loss for Fiscal 2025 was approximately $7.1 million or $0.09 per share, compared to approximately $13 million or $0.22 per share for Fiscal 2024 an improvement of about $6 million.
Looking Ahead to Fiscal 2026 - IGC Pharma is strategically positioned for continued growth and innovation. Key objectives include: (1) completing the CALMA Phase 2 trial; (2) launching a second Phase 2 study to evaluate IGC-AD1's potential disease-modifying effects; and (3) deploying a beta version of MINT-AD, our AI-based diagnostic tool. We remain committed to creating long-term value for shareholders and accelerating breakthroughs that can change the lives of those affected by Alzheimer's disease.
Investor Call Today at 11:00 a.m. ET
The Company will host a conference call and webcast on Monday, June 30, 2025, at 11:00 a.m. Eastern Time to review the Company's operational progress for the fiscal year ended March 31, 2025.
To participate in the call by phone, dial (888) 506 0062 approximately five minutes prior to the scheduled start time. International callers please dial (973) 528 0011. Callers should use access code: 370284.
Investors may access the live webcast via the following link:
https://www.webcaster4.com/Webcast/Page/2938/52547
A replay of the teleconference will be available at the above link until Tuesday, September 30, 2025.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 30 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
Forward-Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.
Contact Information
Rosalyn Christian/Walter Frank
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
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