IGC Pharma Reports First Quarter Fiscal 2025 Results

Rhea-AI Summary

IGC Pharma reported its Q1 FY2025 results, highlighting significant progress in its Alzheimer's research portfolio. The company's lead drug candidate, IGC-AD1, showed promising interim data in its Phase 2 clinical trial for agitation in Alzheimer's. Additionally, TGR-63 demonstrated positive pre-clinical results in an Alzheimer's mouse model. Despite these advancements, IGC's revenue decreased by 51% to $272,000 compared to the same period last year. The company's R&D expenses increased by 19% to $889,000, reflecting the expansion of clinical trials. The net loss for the quarter was $2.4 million or $0.03 per share. IGC also extended its $12 million loan agreement with O-Bank for another year.

Positive

• Interim data from Phase 2 clinical trial of IGC-AD1 shows clinically significant reduction in agitation in Alzheimer's
• Positive pre-clinical results for TGR-63 in combating Alzheimer's disease in a mouse model
• Extension of $12 Million Master Loan and Security Agreement with O-Bank for one year
• Expansion of clinical trial footprint and patient enrollment

Negative

• Revenue decreased by 51% to $272,000 compared to the same period last year
• Net loss increased to $2.4 million from $2.1 million in the previous year
• R&D expenses increased by 19% to $889,000
• SG&A expenses increased by 1% to $1.7 million

Insights

Financial Analyst

IGC Pharma's Q1 FY2025 results reveal a mixed financial picture. Revenue decreased by 51% to $272,000, primarily due to the completion of legacy projects. However, the company's strategic focus on Life Sciences is evident. R&D expenses increased by 19% to $889,000, reflecting ongoing investment in Alzheimer's research. The net loss widened to $2.4 million ($0.03 per share) from $2.1 million last year. While the revenue decline is concerning, the increased R&D spending and promising clinical trial results suggest potential for future growth. The $12 million untapped credit line provides financial flexibility for continued research and development efforts.

Medical Research Analyst

IGC Pharma's Q1 FY2025 shows significant progress in Alzheimer's research. The interim data from the Phase 2 trial of IGC-AD1 demonstrating a clinically significant reduction in agitation is promising. The addition of AI expert Dr. Pablo Arbelaez could accelerate trial development. Moreover, the positive pre-clinical results for TGR-63 in an Alzheimer's mouse model are encouraging. These advancements position IGC-AD1 and TGR-63 as potential game-changers in Alzheimer's treatment. However, it's important to note that clinical trials are ongoing and final results will be pivotal for the company's future in the competitive Alzheimer's drug market.

Market Research Analyst

IGC Pharma's strategic pivot towards Life Sciences, particularly Alzheimer's research, aligns with a growing market opportunity. The global Alzheimer's therapeutics market is projected to reach $14.8 billion by 2026, with a CAGR of 9.1%. IGC's focus on agitation in Alzheimer's addresses a critical unmet need, potentially capturing a significant market share if successful. The company's vertically integrated model could provide a competitive edge in terms of cost management and speed to market. However, investors should be cautious of the high-risk nature of biotech investments, especially given the company's current financial performance and the long road to potential commercialization.

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the first fiscal quarter of 2025 ended June 30, 2024.

Q1 FY2025 Company’s Highlights

• On April 9, 2024, the Company welcomed Pablo Arbelaez, Ph.D., a renowned AI expert and researcher, to support the development of the Phase 2 clinical trial of IGC-AD1, the lead therapeutic candidate addressing agitation in Alzheimer’s disease.
• On April 16, 2024, the Company announced that interim data from its Phase 2 clinical trial demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.
• On May 28, 2024, the Company announced patient enrollment at Neurostudies, Inc. in Port Charlotte, Florida, for its ongoing Phase 2 clinical trial investigating IGC-AD1, the lead investigational drug, as a potential treatment for agitation in Alzheimer’s disease.
• On June 25, 2024, the Company shared positive pre-clinical results for TGR-63, showing its potential in combating Alzheimer’s disease in an Alzheimer’s mouse model.
• The Company and O-Bank, Co. Ltd. extended the Master Loan and Security Agreement for $12 Million, by one year. The Extension is effective July 8, 2024. The Company paid a facility fee of $84,000 for the facility as set out in Form 8-K filed on July 29, 2024.

Ram Mukunda, CEO of IGC Pharma, commented, “The first quarter of fiscal 2025 was marked by significant milestones in our Alzheimer’s research portfolio, underscoring our strategic focus on our innovations. The progress in our Phase 2 clinical trial for IGC-AD1, highlighted by interim data demonstrating a clinically significant reduction in agitation, validates the immense potential of our lead investigational drug. Additionally, the positive pre-clinical outcomes for TGR-63 underscore its promise as a transformative therapy for Alzheimer’s, advancing us closer to delivering a novel solution for this critical unmet need. We are strategically positioned to continue expanding our clinical trial footprint and patient enrollment throughout fiscal 2025 as we continue to drive toward commercialization while maximizing operational efficiency and leveraging our unique vertically integrated model.”

Financial Summary

During the three months ended June 30, 3024, the Company generated approximately $272 thousand in revenue, representing a decrease of 51% compared to the approximately $555 thousand generated during the three months ended June 30, 2023. The decrease in revenue is attributed to the completion of our legacy Infrastructure project in India as well as some white-label project in the U.S., both of which comprised approximately 50% of the June 2023 revenue. The Company is committed to its current strategy of driving sales in formulations in the Life Science segment.

The Company reported Selling, General, and Administrative (“SG&A”) expenses during the three months ended June 30, 2024, of approximately $1.7 million, representing an increase of approximately $23 thousand, or 1%, compared to the three months ended June 30, 2023.

During the three months ended June 30, 2024, the Company reported Research and Development (“R&D”) expenses of approximately $889 thousand, representing an increase of approximately $142 thousand or 19% compared to the three months ended June 30, 2023. The increase is primarily attributable to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on the other small molecule assets. We anticipate increased R&D expenses as the development of our other small molecule assets targeting Alzheimer’s and the Phase 2 trial on Alzheimer’s expand.

The net loss for the three months ended June 30, 2024, was approximately $2.4 million or $0.03 per share, compared to approximately $2.1 million or $0.04 per share for three months ended June 30, 2023.

As of June 30, 2024, the Company has not used any of the $12 million available under the Credit Agreement with O-Bank.

About IGC Pharma (dba IGC):

IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease with the mission to transform patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical stages, focusing on tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia associated with Alzheimer’s (clinicaltrials.gov, NCT05543681). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict affinity to other neurological disorders, GLP-1, GIP, CB1 receptors, among others. With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer’s and related conditions.

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 24, 2024, and on Form 10-Q filed with the SEC on August 07, 2024, 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.

IGC Pharma, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) (Unaudited)
		June 30, 2024 ($)					March 31, 2024 ($)
ASSETS
Current assets:
Cash and cash equivalents			1,824					1,198
Accounts receivable, net			28					39
Inventory			1,510					1,540
Asset held for sale			720					720
Deposits and advances			325					208
Total current assets			4,407					3,705
Non-current assets:
Intangible assets, net			1,720					1,616
Property, plant, and equipment, net			3,586					3,695
Claims and advances			688					688
Operating lease asset			193					198
Total non-current assets			6,187					6,197
Total assets			10,594					9,902
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable			771					773
Accrued liabilities and others			1,718					1,567
Total current liabilities			2,489					2,340
Non-current liabilities:
Long-term loans			136					137
Other liabilities			20					20
Operating lease liability			69					84
Total non-current liabilities			225					241
Total liabilities			2,714					2,581
Commitments and Contingencies – See Note 12
Stockholders’ equity:
Preferred stock, $0.0001 par value: authorized 1,000,000 shares, no shares issued or outstanding as of June 30, 2024, and March 31, 2024.
Common stock and additional paid-in capital, $0.0001 par value: 150,000,000 shares authorized; 75,636,419 and 66,691,195 shares issued and outstanding as of June 30, 2024, and March 31, 2024, respectively.			127,349					124,409
Accumulated other comprehensive loss			(3,426	)				(3,423	)
Accumulated deficit			(116,043	)				(113,665	)
Total stockholders’ equity			7,880					7,321
Total liabilities and stockholders’ equity			10,594					9,902

These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 07, 2024.

IGC Pharma, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except loss per share and share data) (Unaudited)
		Three months ended June 30,
		2024 ($)					2023 ($)
Revenue			272					555
Cost of revenue			(109	)				(300	)
Gross profit			163					255
Selling, general and administrative expenses			(1,670	)				(1,647	)
Research and development expenses			(889	)				(747	)
Operating loss			(2,396	)				(2,139	)
Other income, net			18					64
Loss before income taxes			(2,378	)				(2,075	)
Income tax expense/benefit			-					-
Net loss attributable to common stockholders			(2,378	)				(2,075	)
Foreign currency translation adjustments			(3	)				9
Comprehensive loss			(2,381	)				(2,066	)
Loss per share attributable to common stockholders:
Basic and diluted		$	(0.03	)			$	(0.04	)
Weighted-average number of shares used in computing loss per share amounts:			72,813,538					53,077,436

These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended June 30, 2024, and was filed with the SEC on August 07, 2024.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240808215193/en/

Rosalyn Christian

IMS Investor Relations

(203) 972-9200

igc@imsinvestorrelations.com

Source: IGC Pharma, Inc.

FAQ

What were IGC Pharma's (IGC) Q1 FY2025 financial results?

IGC Pharma reported revenue of $272,000, a 51% decrease from the previous year. The net loss was $2.4 million or $0.03 per share, compared to $2.1 million or $0.04 per share in Q1 FY2024.

What progress did IGC Pharma (IGC) make in its Alzheimer's research during Q1 FY2025?

IGC Pharma reported promising interim data from its Phase 2 clinical trial of IGC-AD1 for agitation in Alzheimer's, and positive pre-clinical results for TGR-63 in an Alzheimer's mouse model.

How did IGC Pharma's (IGC) R&D expenses change in Q1 FY2025?

IGC Pharma's R&D expenses increased by 19% to $889,000 compared to the same period last year, primarily due to the progression of Phase 2 trials on IGC-AD1 and pre-clinical studies on other small molecule assets.

What financial arrangement did IGC Pharma (IGC) extend in Q1 FY2025?

IGC Pharma extended its Master Loan and Security Agreement with O-Bank for $12 Million by one year, effective July 8, 2024, paying a facility fee of $84,000.