POTOMAC, MD / ACCESS Newswire / September 29, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease. The new site, Ichor Research, located in Syracuse, New York, is led by Principal Investigator Dr. Karl F. ...

POTOMAC, MD / ACCESS Newswire / September 24, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced preclinical findings on TGR-63, the Company's investigational small-molecule candidate for Alzheimer's disease. The data demonstrate that TGR-63 extends its therapeutic potential beyond previously reported effects on beta-amyloid (A) pathology by also inhibiting tau protein aggregation, another key hallmark of Alzheimer's. ...

POTOMAC, MD / ACCESS Newswire / September 22, 2025 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage pharmaceutical company focused on therapies for Alzheimer's disease, today announced it has reached a key enrollment milestone of 50% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease. This milestone marks a significant step in advancing IGC-AD1, the Company's proprietary formulation that combines low concentrations of delta-9 tetrahy ...

Company Performance - IGC Pharma, Inc. reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.03, representing an earnings surprise of +33.33% [1] - The company posted revenues of $0.33 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 0.61%, but showing an increase from $0.27 million year-over-year [2] - Over the last four quarters, IGC Pharma has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Movement and Outlook - IGC Pharma shares have increased by approximately 5.7% since the beginning of the year, compared to a 10% gain in the S&P 500 [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to those expectations [4] - The current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $0.49 million, and for the current fiscal year, it is -$0.11 on revenues of $1.5 million [7] Industry Context - The Medical - Drugs industry, to which IGC Pharma belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact IGC Pharma's stock performance [5][6]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) IGC Pharma's Q1 FY2026 financials show increased revenue and reduced net loss, with assets decreasing and cash slightly increasing [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $7.94 million, liabilities reduced to $1.87 million, and stockholders' equity slightly declined to $6.08 million | Financial Item | June 30, 2025 ($ thousands) | March 31, 2025 ($ thousands) | | :--- | :--- | :--- | | **Total Current Assets** | 2,153 | 2,896 | | **Total Assets** | 7,943 | 8,747 | | **Total Current Liabilities** | 1,725 | 2,257 | | **Total Liabilities** | 1,865 | 2,417 | | **Total Stockholders' Equity** | 6,078 | 6,330 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue increased to $328 thousand, operating loss improved to $1.9 million, and net loss reduced to $1.6 million | Metric | Three months ended June 30, 2025 ($ thousands) | Three months ended June 30, 2024 ($ thousands) | | :--- | :--- | :--- | | Revenue | 328 | 272 | | Gross Profit | 154 | 163 | | Operating Loss | (1,905) | (2,396) | | Net Loss | (1,599) | (2,378) | | Net Loss Per Share (Basic and Diluted) | $(0.02) | $(0.03) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $6.08 million due to net loss, partially offset by stock issuance and compensation - Stockholders' equity decreased by **$252 thousand** during the quarter, driven by a **$1.6 million** net loss, partially offset by capital raised from stock issuance (**$839 thousand**) and stock-based compensation (**$498 thousand**)[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $1.4 million, offset by $580 thousand from investing and $851 thousand from financing | Cash Flow Activity | Three months ended June 30, 2025 ($ thousands) | Three months ended June 30, 2024 ($ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (1,407) | (1,752) | | Net cash provided by (used in) investing activities | 580 | (131) | | Net cash provided by financing activities | 851 | 2,507 | | **Net increase in cash and cash equivalents** | **49** | **626** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's Alzheimer's drug development, revenue sources, liquidity, and subsequent capital raise - The company's primary focus is on developing treatments for Alzheimer's disease, with its lead drug candidate, IGC-AD1, currently in Phase 2 clinical trials for treating agitation in Alzheimer's patients[30](index=30&type=chunk)[31](index=31&type=chunk) Revenue Source | Revenue Source | Q1 FY2026 ($ thousands) | Q1 FY2025 ($ thousands) | | :--- | :--- | :--- | | White labeling services | 322 | 251 | | Wellness and lifestyle | 6 | 21 | | **Total** | **328** | **272** | - The company extended its **$12 million** credit agreement with O-Bank, which, along with current cash, is expected to support operations for at least the next twelve months[40](index=40&type=chunk)[42](index=42&type=chunk) - Subsequent to the quarter end, through July 31, 2025, the company sold **6,623,085 shares** through its ATM facility for gross proceeds of **$2,623,467** at an average price of **$0.41 per share**[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses advancing IGC-AD1 and MINT-AD, improved financials with increased revenue and reduced loss, strengthened liquidity, and a new digital asset treasury strategy [Overview and Business Strategy](index=23&type=section&id=Overview%20and%20Business%20Strategy) The company focuses on advancing IGC-AD1 Phase 2 trials and MINT-AD AI tool deployment for Alzheimer's, while evaluating non-core asset options - The company's core short-term goals are the completion of the Phase 2 trial for IGC-AD1 and the deployment of the MINT-AD AI diagnostic tool[113](index=113&type=chunk) - During the quarter, the company expanded its clinical trial sites for IGC-AD1 across North America to accelerate patient enrollment and presented positive safety data for the drug's API[116](index=116&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Revenue increased by 21% to $328 thousand, operating loss improved by 20%, and net loss reduced by 33% due to cost optimization and tax credits Metric | Metric | Three months ended June 30, 2025 ($ thousands) | Three months ended June 30, 2024 ($ thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 328 | 272 | 21% | | Gross Profit | 154 | 163 | (6)% | | SG&A Expenses | (1,208) | (1,670) | (28)% | | R&D Expenses | (851) | (889) | (4)% | | Operating Loss | (1,905) | (2,396) | (20)% | | Net Loss | (1,599) | (2,378) | (33)% | - The significant decrease in SG&A expenses by **$462 thousand** (**28%**) was attributed to optimizing operational efficiency, including lower employee-related costs and reduced spending on legal and professional services[119](index=119&type=chunk) - Other net income increased by **1,600%** to **$306 thousand**, primarily due to a tax credit of approximately **$263 thousand** received during the quarter[121](index=121&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is supported by cash, a $12 million credit facility extension, and recent equity financing, including a $2.6 million ATM offering - The company extended its **$12 million** credit facility, with amended terms including a reduction in facility fees and a slight increase in the applicable interest margin[125](index=125&type=chunk) - In the first quarter of Fiscal 2026, the company raised **$841,000** by selling **2,803,333 shares** of common stock at **$0.30 per share** through Share Purchase Agreements[126](index=126&type=chunk) - Subsequent to the quarter, the company raised an additional **$2,623,467** by selling **6,623,085 shares** through its ATM at an average price of **$0.41**[127](index=127&type=chunk) [Treasury Strategy and Critical Accounting Policies](index=28&type=section&id=Treasury%20Strategy%20and%20Critical%20Accounting%20Policies) Management plans to invest in digital assets like bitcoin, establishing a new critical accounting policy for fair value measurement - Management plans to implement a new treasury policy in the quarter ending September 30, 2025, allowing for investment in digital assets like bitcoin to diversify treasury holdings[139](index=139&type=chunk)[140](index=140&type=chunk) - A new critical accounting policy for Digital Asset Investments has been established. Direct holdings will be accounted for under ASC 350-60 and measured at fair value, with changes recognized in earnings[143](index=143&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable as the company qualifies as a smaller reporting company - The company is a smaller reporting company, and therefore, is not required to provide the information under this item[148](index=148&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - Based on an evaluation as of the end of the reporting period, the Chief Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective[150](index=150&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter that have materially affected or are reasonably likely to materially affect it[151](index=151&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a pending contractual dispute in Colombia, alleging fraud against four individuals, with no material changes this quarter - The company has a pending legal proceeding in Colombia involving a contractual dispute, where it has filed a complaint alleging fraud and other crimes against four individuals[155](index=155&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) A new material risk factor has been identified regarding the company's potential investment in highly volatile digital assets - A new risk factor has been added regarding the company's plan to invest in digital assets like bitcoin[157](index=157&type=chunk) - Key risks associated with digital asset investment include price volatility, regulatory uncertainty, custody and operational risks, and potential negative impacts on earnings and financial position[159](index=159&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company sold 2,803,333 common shares for $841,000 in an unregistered private placement under Section 4(a)(2) of the Securities Act - The company sold **2,803,333 shares** of common stock in an unregistered private placement for gross proceeds of **$841,000** (**$0.30 per share**)[160](index=160&type=chunk) [Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - The company reported no defaults upon senior securities during the period[161](index=161&type=chunk) [Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[162](index=162&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No other information was reported under this item - The company reported no other information under this item[163](index=163&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) The report includes key exhibits such as the O-Bank loan extension, officer certifications, and XBRL data files - Key exhibits filed with the report include the extension of the Master Loan Agreement (Exhibit 10.1) and officer certifications (Exhibits 31.1, 31.2, 32.1)[164](index=164&type=chunk)

Financial Data and Key Metrics Changes - The company is focused on minimizing dilution and maintaining a clean cap table, having renewed a $12 million line of credit and funding the business through selective capital raises [27] - The company aims to keep clinical trial costs low, achieving approximately half the typical cost per patient for Phase II trials, which usually range from $100,000 to $150,000 [28] Business Line Data and Key Metrics Changes - The lead asset, IGC-81, is in a Phase II trial for agitation in Alzheimer's dementia, with 146 participants currently enrolled across 22 sites [9][10] - The company has made significant progress on the CALMA trial, adding several new sites and utilizing geo-targeting strategies to enhance patient recruitment [5][12] Market Data and Key Metrics Changes - Agitation affects about 76% of Alzheimer's patients, with approximately 50 million Alzheimer's patients worldwide, including 7 million in the US [7] - The current market for Alzheimer's treatments includes cognitive enhancers and recently approved disease-modifying therapies, with IGC-81 positioned as a potential alternative [32][33] Company Strategy and Development Direction - The company is advancing its AI platform for early detection of Alzheimer's and has developed a new diagnostic model called MINT AD [20][23] - The strategy includes expanding the pipeline into GLP-1 based therapies, targeting both Alzheimer's and metabolic disorders, which could open up a multibillion-dollar market [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trial's progress and the potential for IGC-81 to serve as a disease-modifying therapy, which could significantly enhance the company's valuation [70][71] - The focus is on completing the Phase II trial and launching IGC-81 as a disease-modifying therapy, with positive results expected to drive higher valuations [69][70] Other Important Information - The company has been recognized by the NIH for innovation and is a finalist in the NIA Prepare Challenge for early Alzheimer's detection [24] - The AI model MINT AD aims to identify high-risk groups for Alzheimer's and predict cognitive decline, which could serve as a valuable tool for general practitioners [21][23] Q&A Session Summary Question: Insight into the competitive landscape for Alzheimer's drugs - Management highlighted that current treatments primarily include cognitive enhancers and recently approved disease-modifying therapies, with IGC-81 positioned as a differentiated oral therapy [32][33] Question: Adequacy of trial sites for current trials - Management confirmed that they have 22 sites and are using geo-targeting strategies to increase patient enrollment by approximately 200% [36] Question: Impact of social media on clinical trial costs - Management indicated that the cost of using social media for recruitment would be marginal, budgeting about $1,000 per recruited patient [41][42] Question: Timeline for CALMA trial completion - Management expects to finish the CALMA trial by March of next year, with ongoing discussions for future trials related to amyloid and tau [50][52] Question: Concerns regarding ARIA with current therapies - Management stated that IGC-81 is not a monoclonal antibody and does not expect ARIA, emphasizing its safety profile [56] Question: Positioning against traditional cannabis use - Management clarified that IGC-81 is a medication with controlled dosing and replicability, differentiating it from recreational cannabis [58][60] Question: Expectations for G&A expenses going forward - Management noted a refocus on key priorities, which has led to a reduction in G&A expenses, aiming to complete trials efficiently [63][66]

Financial Data and Key Metrics Changes - The company is focused on minimizing dilution and maintaining a clean cap table, having renewed a $12 million line of credit and funding through selective capital raises [26] - The cost per patient in Phase II trials is significantly lower than industry standards, with the company managing to conduct trials at about half the typical cost of $100,000 to $150,000 per patient [27] Business Line Data and Key Metrics Changes - The lead asset, IGC-81, is in a Phase II trial for agitation in Alzheimer's dementia, with 146 participants currently enrolled across 22 sites [9][10] - The company has made significant progress on the CALMA trial, adding several new sites and utilizing geo-targeting strategies to increase patient recruitment by about 200% [12][36] Market Data and Key Metrics Changes - Agitation affects approximately 76% of Alzheimer's patients, with around 50 million Alzheimer's patients worldwide and about 7 million in the U.S. [7] - The current Alzheimer's treatment landscape includes cognitive enhancers and recently approved disease-modifying therapies, but challenges remain regarding cost and eligibility [32] Company Strategy and Development Direction - The company is advancing its pipeline into the GLP-1 portfolio, which could target a multibillion-dollar market for metabolic disorders [25] - The focus is on completing the Phase II trial for IGC-81 and launching it as a disease-modifying therapy, with plans to initiate IND enabling studies for pipeline expansion [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trial's progress and the potential for IGC-81 to serve as a complementary or alternative solution in the symptomatic management of Alzheimer's [35] - The company is excited about the MINT AD AI model, which aims to help diagnose Alzheimer's risk factors and predict cognitive decline [22][64] Other Important Information - The company has been recognized by the NIH for innovation and was selected as a top finalist in the NIA Prepare Challenge for early Alzheimer's detection [23] - The beta version of the MINT AD model is operational and aims to assist general practitioners in diagnosing Alzheimer's [22] Q&A Session Summary Question: Insight into the competitive landscape - The current Alzheimer's treatment landscape includes cognitive enhancers and recently approved disease-modifying therapies, with IGC-81 positioned as a differentiated oral investigational therapy [32][34] Question: Adequacy of trial sites - The company currently has 22 sites and is using geo-targeting strategies to increase enrollment, projecting to meet enrollment targets without needing additional sites [36][37] Question: Cost implications of using social media for recruitment - The budget for recruiting new patients via social media is approximately $1,000 per patient, which will not significantly increase overall trial costs [41] Question: Timeline for CALMA trial top line results - The CALMA trial is expected to finish by March of next year, with the company internally aiming for a more aggressive timeline [49] Question: Concerns about ARIA with the drug - The medication is not a monoclonal antibody, so the company does not expect ARIA and has not seen any indications of it [55] Question: Positioning against traditional cannabis - The drug is a combination medication with controlled dosing, differentiating it from traditional cannabis use [57][60] Question: Future expectations for G&A expenses - The company has refocused on key priorities, which has led to a reduction in G&A expenses, aiming to complete trials and develop the MINT AD model [62][65]

Group 1 - IGC Pharma, Inc. reported a quarterly loss of $0.01 per share, better than the Zacks Consensus Estimate of a loss of $0.02, representing an earnings surprise of +50.00% [1] - The company posted revenues of $0.33 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 6.45%, compared to revenues of $0.29 million a year ago [2] - IGC Pharma has surpassed consensus EPS estimates three times over the last four quarters [2] Group 2 - The stock has underperformed the market, losing about 7.7% since the beginning of the year, while the S&P 500 gained 4.4% [3] - The current consensus EPS estimate for the coming quarter is -$0.03 on revenues of $0.33 million, and -$0.11 on revenues of $1.5 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Drugs is in the top 33% of over 250 Zacks industries, indicating a favorable outlook for the industry [8]

Financial Performance - Revenue for Fiscal 2025 decreased by $74 thousand to $1.271 million, a 6% decline from $1.345 million in Fiscal 2024[294] - Gross profit for Fiscal 2025 was $619 thousand, down 16% from $733 thousand in Fiscal 2024, with a gross margin of 49% compared to 54% in the previous year[295] - Total revenue for Fiscal 2025 was $1.271 million, a slight decrease from $1.345 million in Fiscal 2024, with wellness and lifestyle revenue dropping from $228 thousand to $113 thousand[330] Expenses - Selling, general, and administrative expenses decreased by 35% to approximately $4.4 million in Fiscal 2025, down from $6.7 million in Fiscal 2024[297] - Research and development expenses were approximately $3.7 million in Fiscal 2025, a decrease of 3% from $3.8 million in Fiscal 2024[298] - Net cash used in operating activities for Fiscal 2025 was approximately $4.8 million, a decrease of 8% compared to $5.2 million in Fiscal 2024[316][318] Trial Results - The Phase 2 trial of IGC-AD1 showed a 71% reduction in sleep disturbances at week 2 and a 78% reduction at week 6 compared to placebo[282] - No serious adverse events were reported in the Phase 2 trial, indicating a favorable safety profile for IGC-AD1[292] - The company successfully optimized trial operations, reducing the cost per patient enrolled in the Phase 2 trial to approximately $70 thousand, significantly lower than industry norms of $100 thousand to $150 thousand[280][281] Financing Activities - The company raised over $4.64 million through private equity placements and ATM offerings during Fiscal 2025[296] - Net cash provided by financing activities was approximately $4.4 million for Fiscal 2025, an increase of 26% from $3.5 million in Fiscal 2024[321][322] - The Company raised approximately $3 million in gross proceeds through a Share Purchase Agreement with Bradbury Strategic Investment Fund A, receiving $500 thousand during fiscal 2024 and $2.1 million in April 2024[307] Capital and Assets - Cash and cash equivalents decreased by approximately $793 thousand to $405 thousand in Fiscal 2025, representing a 66% decline from $1.2 million in Fiscal 2024[315] - The Company capitalized approximately $863 thousand in software development costs during Fiscal 2025, focusing on integrating machine learning and AI into clinical trial software[336] - The Company impaired land in Nagpur, India, by approximately $3.3 million during Fiscal 2024, reducing its value from $4.1 million to $720 thousand[333] Shareholder Agreements - The company has entered into a Sales Agreement to offer and sell shares of its common stock with an aggregate offering price of up to $60 million[305] - The Company entered into a Share Purchase Agreement in September 2024, selling 588,235 shares at $0.34 per share for a total of $200,000[309] - The Company expects to utilize its shelf registration to raise capital through at-the-market offerings, subject to limitations on the amount of capital that can be raised[311] Currency and Exchange Rates - The Company operates in multiple currencies, with significant financials denominated in Indian Rupee (INR) and Colombian Peso (COP), affecting its financial statements due to exchange rate fluctuations[337]

Core Viewpoint - IGC Pharma, Inc. reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.03, marking a 33.33% earnings surprise [1][2] Financial Performance - The company posted revenues of $0.26 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 28.50%, compared to $0.2 million in the same quarter last year [2] - Over the last four quarters, IGC Pharma has surpassed consensus EPS estimates two times [2] Stock Performance - IGC Pharma shares have declined approximately 9% since the beginning of the year, while the S&P 500 has gained 4% [3] - The current Zacks Rank for IGC Pharma is 3 (Hold), indicating expected performance in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $0.3 million, and for the current fiscal year, it is -$0.11 on revenues of $1.18 million [7] - The trend of earnings estimate revisions is mixed ahead of the earnings release, which could influence future stock movements [6][7] Industry Context - The Medical - Drugs industry, to which IGC Pharma belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, United Therapeutics, is expected to report quarterly earnings of $6.23 per share, reflecting a year-over-year increase of 42.9% [9]