POTOMAC, Md., February 17, 2024–(BUSINESS WIRE)–IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the third fiscal quarter of 2024 ended December 31, 2023 (Q3 FY 2024).
Q3 FY2024 Highlights
- On October 18, 2023, the European Patent Office (“EPO”) issued a patent (#3193862) to the Company titled “Cannabinoid Composition and Method for Treating Pain”. The patent introduces a method for treating pain in humans. Utilizing a cream base infused with a unique blend of cannabinoids, including THC and CBD, alongside other compounds, this revolutionary cream, or gel is designed for transdermal absorption.
- On October 25, 2023, the Divisional Direction of Patents, Mexico, issued a patent (MX/a/2020/010284) for the Company’s treatment of Alzheimer’s disease titled “Method and Composition for Treating CNS Disorder.” IGC is optimistic that the success in Mexico can pave the way for additional patent approvals in the U.S. and Europe. This patent is very important to the Company as it provides protection for the Company’s IGC-AD1 formulation.
- On November 21, 2023, the Company announced an agreement with the University of Los Andes, a leading South American University, to advance initiatives in artificial intelligence/machine learning.
“We are proud to share that our company is making progress with our lead asset, IGC-AD1, which is currently in a Phase 2b trial for the treatment of agitation in dementia due to Alzheimer’s. We are working hard to obtain interim results in 2024. We estimate that in North America and Europe about 11 million Alzheimer’s patients have neuropsychiatric symptoms including agitation. With modest pricing and conservative market penetration IGC-AD1 can potentially be a block buster drug,” said Ram Mukunda, CEO of IGC Pharma.
Along with IGC-AD1, the Company has four other drug assets, LMP, TGR-63, IGC-1C, and IGC-M3, three of which have demonstrated pre-clinical efficacy in targeting Alzheimer’s disease. We continue to explore new methods to improve the efficiency of our clinical trials and have recently started to utilize artificial intelligence (AI) to analyze the large amount of data produced by our trials.
Financial Summary
During the three months ended December 31, 2023, the Company generated approximately $204 thousand in revenue, representing a decrease of 38% compared to the approximately $332 thousand generated during the three months ended December 31, 2022. For the nine months ended December 31, 2023, the Company generated approximately $1.05 million in revenue versus $745 thousand for the previous year nine months, representing an increase of 40%. The primary source of revenue in both quarters was from the Life Sciences segment, encompassing the sales of our formulations. The decrease in revenue in the quarter is primarily because the Company reorganized resources to focus on accelerating the Phase 2 trial and obtaining pharmaceutical GMP certification for its facility in preparation for a potential Phase 3 trial.
The Company reported Selling, General, and Administrative (“SG&A”) expenses during the three months ended December 31, 2023, of approximately $2.2 million, representing an increase of approximately $654 thousand, or 42%, compared to the approximately $1.5 million recorded for the three months ended December 31, 2022. The increase in SG&A expenses is primarily attributed to one-time non-cash expenses.
During the three months ended December 31, 2023, the Company reported Research and Development (“R&D”) expenses of approximately $903 thousand, representing an increase of approximately $97 thousand or 12% compared to approximately $806 thousand during the three months ended December 31, 2022. 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.
The net loss for the three months ended December 31, 2023, was approximately $5.5 million or $0.09 per share, compared to approximately $2.2 million or $0.04 per share for three months ended December 31, 2022. The increased loss is from an impairment of PPE assets in the amount of approximately $2.6 million and a one-time non-cash expense of $654 thousand reported in SG&A. The Company estimates that its current cash and cash equivalents balance with working capital credit facility is sufficient to support operations beyond the twelve months following the date the consolidated financial statements and footnotes were issued. The estimates are based on assumptions that may prove to be wrong, and the Company could use its available capital resources sooner than it currently expects.
About IGC Pharma (dba IGC)
IGC Pharma is pursuing innovative solutions to fight Alzheimer’s disease and related challenges. IGC Pharma’s portfolio comprises five assets, all with a singular mission – to transform the landscape of Alzheimer’s treatment. IGC-AD1 and LMP target neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently in a Phase 2b clinical trial for agitation in dementia due to Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 targets Aβ plaque to disrupt the progression of Alzheimer’s disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles in a forward-thinking approach to Alzheimer’s therapy. In parallel, IGC Pharma is at the forefront of Generative AI development, with projects including clinical trials, early detection of Alzheimer’s, and drug interactions with cannabinoids.
Forward-looking Statements
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC’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’s U.S. Securities and Exchange Commission (“SEC”) filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, and the Form 10-Q for the fiscal quarter ended December 31, 2023, and other documents that we subsequently file with the SEC that update, 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.
< Financial Tables to Follow>
| IGC Pharma, Inc.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share data)(Unaudited) | ||||||||||
| December 31, 2023($) | March 31,2023 ($) | |||||||||
| ASSETS | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | 1,378 | 3,196 | ||||||||
| Accounts receivable, net | 92 | 107 | ||||||||
| Short term investments | – | 154 | ||||||||
| Inventory | 1,925 | 2,651 | ||||||||
| Deposits and advances | 188 | 358 | ||||||||
| Total current assets | 3,583 | 6,466 | ||||||||
| Non-current assets: | ||||||||||
| Intangible assets, net | 1,182 | 1,170 | ||||||||
| Property, plant, and equipment, net | 5,268 | 8,213 | ||||||||
| Claims and advances | 999 | 1,003 | ||||||||
| Operating lease asset | 227 | 326 | ||||||||
| Total non-current assets | 7,676 | 10,712 | ||||||||
| Total assets | 11,259 | 17,178 | ||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | 648 | 530 | ||||||||
| Accrued liabilities and others | 1,288 | 1,368 | ||||||||
| Total current liabilities | 1,936 | 1,898 | ||||||||
| Non-current liabilities: | ||||||||||
| Long-term loans | 138 | 141 | ||||||||
| Other liabilities | 17 | 21 | ||||||||
| Operating lease liability | 115 | 207 | ||||||||
| Total non-current liabilities | 270 | 369 | ||||||||
| Total liabilities | 2,206 | 2,267 | ||||||||
| 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 December 31, 2023, and March 31, 2023. | ||||||||||
| Common stock and additional paid-in capital, $0.0001 par value: 150,000,000 shares authorized; 63,734,439 and 53,077,436 shares issued and outstanding as of December 31, 2023, and March 31, 2023, respectively. | 123,258 | 118,965 | ||||||||
| Accumulated other comprehensive loss | (3,425 | ) | (3,389 | ) | ||||||
| Accumulated deficit | (110,780 | ) | (100,665 | ) | ||||||
| Total stockholders’ equity | 9,053 | 14,911 | ||||||||
| Total liabilities and stockholders’ equity | 11,259 | 17,178 | ||||||||
These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended December 31, 2023, filed with the SEC on February 14, 2024.
| IGC Pharma, Inc.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except loss per share and share data)(Unaudited) | ||||||||||||||||
| Three months endedDecember 31, | Nine months endedDecember 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| ($) | ($) | ($) | ($) | |||||||||||||
| Revenue | 204 | 332 | 1,050 | 745 | ||||||||||||
| Cost of revenue | (71 | ) | (230 | ) | (488 | ) | (366 | ) | ||||||||
| Gross profit | 133 | 102 | 562 | 379 | ||||||||||||
| Selling, General and Administrative expenses | (2,228 | ) | (1,574 | ) | (5,272 | ) | (4,943 | ) | ||||||||
| Research and development expenses | (903 | ) | (806 | ) | (2,918 | ) | (2,968 | ) | ||||||||
| Operating loss | (2,998 | ) | (2,278 | ) | (7,628 | ) | (7,532 | ) | ||||||||
| Impairment Loss on PPE | (2,623 | ) | – | (2,623 | ) | – | ||||||||||
| Other income, net | 32 | 29 | 136 | 56 | ||||||||||||
| Loss before income taxes | (5,589 | ) | (2,249 | ) | (10,115 | ) | (7,476 | ) | ||||||||
| Income tax expense/benefit | – | – | – | – | ||||||||||||
| Net loss attributable to common stockholders | (5,589 | ) | (2,249 | ) | (10,115 | ) | (7,476 | ) | ||||||||
| Foreign currency translation adjustments | 18 | (61 | ) | (36 | ) | (462 | ) | |||||||||
| Comprehensive loss | (5,571 | ) | (2,310 | ) | (10,151 | ) | (7,938 | ) | ||||||||
| Net loss per share attributable to common stockholders: | ||||||||||||||||
| Basic and diluted | $ | (0.09 | ) | (0.04 | ) | (0.18 | ) | (0.14 | ) | |||||||
| Weighted-average number of shares used in computing net loss per share amounts: | 63,725,084 | 53,063,473 | 57,039,035 | 52,412,830 | ||||||||||||
These financial statements should be read in connection with the accompanying notes on Form 10-Q for the quarter ended December 31, 2023, and filed with the SEC on February 14, 2024.
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