IGC Pharma Reports Third Quarter Fiscal 2024 Results
- IGC received a patent from the European Patent Office for a unique cannabinoid composition to treat pain in humans.
- Another patent was issued by the Divisional Direction of Patents in Mexico for IGC's treatment of Alzheimer's disease.
- IGC partnered with the University of Los Andes to advance initiatives in artificial intelligence and machine learning.
- The company's lead asset, IGC-AD1, is in a Phase 2b trial for agitation in dementia due to Alzheimer's, with interim results expected in 2024.
- None.
Insights
The patents granted to IGC Pharma for their cannabinoid-based pain treatment and Alzheimer's disease therapy represent significant intellectual property milestones. These patents not only protect the company's proprietary formulations but also potentially increase the company's valuation due to the extended market exclusivity they provide. The unique cannabinoid blend for pain management could disrupt the analgesic market, particularly if it offers a safer alternative to opioids. The Alzheimer's treatment patent in Mexico, coupled with the anticipation of approvals in other jurisdictions, could enhance IGC's strategic positioning in the global CNS disorder treatment market, which is projected to reach $128.9 billion by 2025.
IGC's collaboration with the University of Los Andes to incorporate AI and machine learning in their research could accelerate drug development processes, potentially reducing costs and time to market. Their focus on the Phase 2b trial for IGC-AD1, targeting agitation in dementia due to Alzheimer's, addresses a significant unmet medical need. With an estimated 5.8 million Americans living with Alzheimer's in 2020 and this number projected to rise, the market opportunity for effective treatments is substantial. If IGC-AD1 shows positive interim results in 2024, this could positively influence the company's stock as investors anticipate the potential for FDA approval and market entry.
Investors should monitor IGC's financials closely, particularly cash flow and R&D expenditures, as the company progresses through clinical trials. The cost of conducting a Phase 2b trial can be substantial and the company's ability to finance these operations is critical for continued development. Positive trial results could lead to partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies. On the flip side, any negative outcomes or delays could impact the company's financial health and investor confidence. The long-term potential of IGC's proprietary treatments should be weighed against the inherent risks of biotech investing, including regulatory hurdles and market competition.
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 inMexico can pave the way for additional patent approvals in theU.S. andEurope . 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
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
The Company reported Selling, General, and Administrative (“SG&A”) expenses during the three months ended December 31, 2023, of approximately
During the three months ended December 31, 2023, the Company reported Research and Development (“R&D”) expenses of approximately
The net loss for the three months ended December 31, 2023, was approximately
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
< Financial Tables to Follow>
IGC Pharma, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) (Unaudited) |
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December 31,
($) |
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March 31,
2023
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
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1,378 |
|
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|
|
3,196 |
|
|
Accounts receivable, net |
|
|
92 |
|
|
|
|
107 |
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Short term investments |
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- |
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|
154 |
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Inventory |
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1,925 |
|
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|
|
2,651 |
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Deposits and advances |
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|
188 |
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|
358 |
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Total current assets |
|
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3,583 |
|
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|
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6,466 |
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Non-current assets: |
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Intangible assets, net |
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1,182 |
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|
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1,170 |
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Property, plant, and equipment, net |
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5,268 |
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8,213 |
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|
Claims and advances |
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|
999 |
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1,003 |
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Operating lease asset |
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227 |
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|
326 |
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Total non-current assets |
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7,676 |
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|
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10,712 |
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Total assets |
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11,259 |
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17,178 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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648 |
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|
530 |
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Accrued liabilities and others |
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1,288 |
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|
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1,368 |
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Total current liabilities |
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1,936 |
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1,898 |
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Non-current liabilities: |
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Long-term loans |
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138 |
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141 |
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Other liabilities |
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17 |
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21 |
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Operating lease liability |
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115 |
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|
207 |
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Total non-current liabilities |
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270 |
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369 |
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Total liabilities |
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2,206 |
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|
|
|
2,267 |
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Commitments and Contingencies – See Note 12 |
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Stockholders’ equity: |
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Preferred stock, |
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Common stock and additional paid-in capital, |
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123,258 |
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118,965 |
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Accumulated other comprehensive loss |
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(3,425 |
) |
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(3,389 |
) |
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Accumulated deficit |
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(110,780 |
) |
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(100,665 |
) |
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Total stockholders’ equity |
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9,053 |
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|
|
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14,911 |
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Total liabilities and stockholders’ equity |
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|
11,259 |
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|
|
|
17,178 |
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|
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) |
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Three months ended December 31, |
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Nine months ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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($) |
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($) |
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($) |
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($) |
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Revenue |
|
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204 |
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|
332 |
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|
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 |
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|
18 |
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|
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(61 |
) |
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(36 |
) |
|
|
(462 |
) |
Comprehensive loss |
|
|
(5,571 |
) |
|
|
(2,310 |
) |
|
|
(10,151 |
) |
|
|
(7,938 |
) |
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Net loss per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
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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 |
|
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|
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240216772877/en/
Investors
IMS Investor Relations
Walter Frank
igc@imsinvestorrelations.com
(203) 972-9200
Media
JVPRNY
Janet Vasquez
jvasquez@jvprny.com
(212) 645-5498
Source: IGC Pharma, Inc.
FAQ
What patents did IGC receive in Q3 FY 2024?
Who did IGC partner with in Q3 FY 2024?
What is IGC's lead asset currently in trial for?
