POTOMAC, Maryland, August 9, 2024–(BUSINESS WIRE)–IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the first quarter of fiscal 2025 ended June 30, 2024.
Company highlights in the first quarter of fiscal year 2025
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On April 9, 2024, the Company welcomed Dr. Pablo Arbelaez, a renowned AI expert and researcher, to support the development of the Phase 2 clinical trial of IGC-AD1, the lead therapeutic candidate for the treatment of agitation in Alzheimer’s disease.
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On April 16, 2024, the company announced that interim data from its Phase 2 clinical trial demonstrated a clinically significant, near statistically significant reduction in agitation in Alzheimer’s disease at week 2 compared to placebo.
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On May 28, 2024, the Company announced patient enrollment at Neurostudies, Inc. in Port Charlotte, Florida, for its ongoing Phase 2 clinical trial evaluating IGC-AD1, its lead investigational drug, as a potential treatment for agitation in Alzheimer’s disease.
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On June 25, 2024, the company announced positive preclinical results for TGR-63, demonstrating its potential to combat Alzheimer’s disease in an Alzheimer’s mouse model.
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The Company and O-Bank, Co. Ltd. have entered into a one-year extension of the $12 million Master Loan and Security Agreement, effective July 8, 2024. The extension will be effective July 8, 2024. The Company paid an origination fee of $84,000 for the facility, as set forth in its Form 8-K dated July 29, 2024.
Ram Mukunda, CEO of IGC Pharma, commented: “The first quarter of FY 2025 was marked by significant milestones in our Alzheimer’s research portfolio, underscoring our strategic focus on our innovations. Progress in our Phase 2 clinical trial for IGC-AD1, underscored by interim data demonstrating clinically significant reductions in agitation, confirms the immense potential of our lead investigational drug. In addition, the positive preclinical results for TGR-63 underscore its promise as a transformative therapy for Alzheimer’s and bring us closer to delivering a novel solution to this critical unmet need. We are strategically positioned to continue to expand our clinical trial footprint and patient enrollment throughout FY 2025 as we continue to work toward commercialization, while maximizing operational efficiencies and leveraging our unique vertically integrated model.”
Financial Summary
For the three months ended June 30, 2024, the Company generated revenues of approximately $272,000, a decrease of 51% from approximately $555,000 generated for the three months ended June 30, 2023. The decrease in revenues was due to the completion of our legacy infrastructure project in India as well as some white label projects in the US, both of which accounted for approximately 50% of revenues in June 2023. The Company remains committed to its current strategy of driving sales from formulations in the Life Science segment.
The Company reported selling, general and administrative expenses (“SG&A”) of approximately $1.7 million for the three months ended June 30, 2024, an increase of approximately $23,000, or 1%, compared to the three months ended June 30, 2023.
For the three months ended June 30, 2024, the Company reported research and development (“R&D”) expenses of approximately $889,000, an increase of approximately $142,000, or 19%, from the three months ended June 30, 2023. The increase was primarily due to the progress of the Phase 2 trials of IGC-AD1 and preclinical studies of the other small molecules. We expect higher R&D expenses as we expand the development of our other small molecules for the treatment of Alzheimer’s disease and the Phase 2 trial in Alzheimer’s disease.
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 the three months ended June 30, 2023.
As of June 30, 2024, the Company has not used any portion of the $12 million available to it 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 and seeking to improve 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 disease. The IGC-C and IGC-M platforms are advancing in preclinical stages, focusing on tau proteins, early plaque formation and several hallmarks of the disease. 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 disease (clinicaltrials.gov, NCT05543681). Interim data for IGC-AD1 have demonstrated its potential to improve patient care by providing faster-acting and more effective relief compared to conventional medications. In addition, our AI models are designed to predict potential biomarkers for early detection of Alzheimer’s, optimize clinical trials, and predict affinity to other neurological disorders, GLP-1, GIP, CB1 receptors, etc. With 28 patent applications and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of people affected by Alzheimer’s and related diseases.
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 a number of risks and uncertainties, some of which are beyond IGC Pharma’s control. Actual results may differ materially from these forward-looking statements due to, among other things, the Company’s failure or inability to commercialize one or more of its products or technologies, including the products or formulations described in this press release; failure to obtain necessary regulatory approval for the products or formulations; government regulations affecting AI or the AI algorithms not performing as intended or failing to provide accurate predictions; general economic conditions being less favorable than expected; the FDA’s general stance regarding cannabis and hemp products; and other factors, many of which are discussed in IGC Pharma’s filings with the U.S. Securities and Exchange Commission (SEC). IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024 and its Annual Report on Form 10-Q filed with the SEC on August 7, 2024 as if fully incorporated and restated herein. Given 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 SHEET (in thousands, excluding share data) (Unverified) |
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June 30, 2024 ($) |
March 31, 2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
1,824 |
1,198 |
|||||||
Trade accounts receivable, net |
28 |
39 |
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inventory |
1,510 |
1,540 |
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Asset held for sale |
720 |
720 |
|||||||
Deposits and advances |
325 |
208 |
|||||||
Total current assets |
4,407 |
3,705 |
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Fixed assets: |
|||||||||
Intangible assets, net |
1,720 |
1,616 |
|||||||
Property, plant and equipment, net |
3,586 |
3,695 |
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Receivables and advances |
688 |
688 |
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Leasing object in operating lease |
193 |
198 |
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Total fixed assets |
6,187 |
6,197 |
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Total assets |
10,594 |
9,902 |
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LIABILITIES AND SHAREHOLDERS‘ EQUITY CAPITAL |
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Short-term liabilities: |
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Accounts payable |
771 |
773 |
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Provisions and Other |
1,718 |
1,567 |
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Total current liabilities |
2,489 |
2,340 |
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Long-term liabilities: |
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Long-term loans |
136 |
137 |
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Other liabilities |
20 |
20 |
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Liabilities from operating leases |
69 |
84 |
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Total long-term liabilities |
225 |
241 |
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Total liabilities |
2,714 |
2,581 |
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Commitments and contingent liabilities – See Note 12 |
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Shareholders‘ Equity capital: |
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Preferred Stock, $0.0001 par value: 1,000,000 shares authorized, no shares issued or outstanding as of June 30, 2024 and March 31, 2024. |
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Common stock and additional paid-in capital, $0.0001 par value: 150,000,000 shares authorized; 75,636,419 and 66,691,195 shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively. |
127,349 |
124,409 |
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Accumulated other comprehensive loss |
(3,426 |
) |
(3,423 |
) |
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Cumulative deficit |
(116,043 |
) |
(113,665 |
) |
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Total number of shareholders‘ Equity capital |
7,880 |
7,321 |
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Total liabilities and shareholders‘ Equity capital |
10,594 |
9,902 |
This financial report should be read in conjunction with the accompanying notes to Form 10-Q for the quarter ended June 30, 2024, which was filed with the SEC on August 7, 2024.
IGC Pharma, Inc. SUMMARY OF THE CONSOLIDATED INCOME STATEMENT (in thousands, excluding loss per share and share data) (Unverified) |
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Three months until June 30, |
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2024 ($) |
2023 ($) |
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revenue |
272 |
555 |
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Cost of revenue |
(109 |
) |
(300 |
) |
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Gross profit |
163 |
255 |
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Selling and administrative overheads |
(1,670 |
) |
(1,647 |
) |
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Research and development costs |
(889 |
) |
(747 |
) |
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Operating loss |
(2,396 |
) |
(2,139 |
) |
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Other income, net |
18 |
64 |
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Loss before income taxes |
(2,378 |
) |
(2,075 |
) |
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Income tax expense/income |
– |
– |
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Net loss attributable to ordinary shareholders |
(2,378 |
) |
(2,075 |
) |
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Currency translation differences |
(3 |
) |
9 |
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Comprehensive insurance damage |
(2,381 |
) |
(2,066 |
) |
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Loss per share attributable to ordinary shareholders: |
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Basic and dilute |
$ |
(0.03 |
) |
$ |
(0.04 |
) |
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Weighted average number of shares used to calculate loss per share: |
72,813,538 |
53,077,436 |
This financial report should be read in conjunction with the accompanying notes on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 7, 2024.
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Contacts
Rosalyn Christian
IMS Investor Relations
(203) 972-9200
[email protected]