India Globalization Capital, Inc. (NYSE American: IGC) (“IGC” or
the “Company”) today reported its second fiscal quarter 2023
financial results.
Second Fiscal Quarter 2023 Highlights:
- IGC-AD1 and TGR-63, both small molecules, have shown potential
to suppress or ameliorate a key protein in Alzheimer’s cell lines
responsible for Aβ plaques, a key hallmark of Alzheimer’s disease.
The Company currently has two main investigational drug assets in
various stages of development:
- IGC-AD1: The Company’s therapeutic candidate is entering Phase
2 trials for treating agitation in dementia from Alzheimer’s
disease.
- TGR-63: An enzyme inhibitor shown in preclinical trials to
reduce neurotoxicity in Alzheimer's cell lines.
- The Company has completed a Phase 1 trial, a safety and
tolerability trial, on IGC-AD1, and has submitted a Phase 2
protocol to the U.S. Food and Drug Administration (“FDA”) and to
Health Canada that involves 146 Alzheimer’s patients, with half
receiving a placebo. The primary endpoint is agitation in dementia
due to Alzheimer’s disease as rated by the Cohen-Mansfield
Agitation Inventory (“CMAI”) over a six-week period. The Company
has signed agreements with trial sites for conducting the
trials.
- On Sept. 20, 2022, the USPTO granted a second patent
(#11,446,276) for the treatment of Alzheimer’s disease titled
“Extreme low dose THC as a therapeutic and prophylactic agent for
Alzheimer’s disease.” The original patent application was initiated
by the University of South Florida (“USF”) and filed on Aug. 1,
2016. On May 25, 2017, the Company entered into an exclusive
license agreement with USF with respect to the patent application
and the associated research conducted on Alzheimer’s disease.
IGC-AD1, described above, is partially based on this research.
- Sales of the Company’s CBD-infused products and services
increased about 345% for the six-months ended September 30, 2022
compared to the six-months ended September 30, 2021.
Ram Mukunda, CEO of India Globalization Capital, commented, “We
are very pleased with the developments we have made this quarter,
especially as they pertain to our investigational drug candidate,
IGC-AD1. We believe that we possess a revolutionary drug
formulation that could provide much-needed relief for patients
suffering from Alzheimer’s disease. This drug is the first natural
low-dose THC (tetrahydrocannabinol)-based drug formulation to enter
FDA trials and has the potential to fill a very prevalent void in
the broad and expanding market for the treatment of Alzheimer’s
symptoms.”
“We continue to see increased market traction for our line of
products like HoliefTM, which offers CBD-based gummies, tinctures,
capsules, and topical analgesic creams for pain relief, and Sunday
SeltzerTM, our CBD-infused beverage brand that includes our energy
drink,” Mukunda continued.
Revenue was approximately $202,000 for the three months ended
Sept. 30, 2022, compared to $56,000 for the three months ended
Sept. 30, 2021. The increase in revenue is primarily related to
increased sales of the Company’s CBD-based products and services
including its CBD-infused energy beverages.
Selling, general, and administrative (“SG&A”) expenses were
approximately $1.9 million and $4.1 million for the three months
ended September 30, 2022, and September 30, 2021, respectively. The
decrease of $2.2 million is attributed to an adjustment of one-time
expenses and a reduction of legal and marketing expenses. SG&A
expenses consist primarily of employee-related expenses, sales
commission, professional fees, legal fees, marketing, other
corporate expenses, allocated general overhead and provisions,
depreciation and write-offs relating to doubtful accounts, and
advance, if any.
Research and Development (“R&D”) expenses were $768,000 for
the three months ended Sept. 30, 2022, compared to approximately
$276,000 for the three months ended Sept. 30, 2021. The increase of
approximately $492,000 was primarily attributable to the
progression of Phase 2 trials on IGC-AD1 and preclinical studies on
TGR-63. The Company anticipates increased R&D expenses as the
development of TGR-63 and the Phase 2 trial on IGC-AD1 gain
momentum.
Net loss for the three months ended Sept. 30, 2022, was
approximately $2.4 million or ($0.05) per share, compared to
approximately $4.3 million or ($0.09) per share for the three
months ended Sept. 30, 2021.
About IGC:
India Globalization Capital Inc. develops, patents and markets
advanced THC-based drug formulations for the treatment of symptoms
related to various diseases, including but not limited to
Alzheimer’s disease, Parkinson’s disease, chronic pain, and pet
seizures. The Company’s leading drug candidate, IGC-AD1, has
demonstrated the potential to be effective in suppressing or
ameliorating a key protein in Alzheimer’s cell lines responsible
for Aβ plaques and has recently entered Phase 2 clinical trials for
agitation in dementia from Alzheimer’s. The Company also has lines
of various CBD-based consumer products such as Holief, which
includes gummies and pain relief creams for women experiencing
premenstrual syndrome (PMS) and dysmenorrhea (period cramps), and
Sunday Seltzer, which includes a CBD-infused energy beverage – all
currently available for purchase. The Company also operates an
Infrastructure business based in India. The Company is
headquartered in Maryland, U.S.A.
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; general economic
conditions that are less favorable than expected, including as a
result of the ongoing COVID-19 pandemic; the FDA’s general position
regarding cannabis- and hemp-based products; and other factors,
many of which are discussed in IGC’s SEC filings. IGC incorporates
by reference the human trial disclosures and Risk Factors
identified in its Annual Report on Form 10-K filed with the SEC on
June 23, 2022, as if fully incorporated and restated herein. In
light of these risks and uncertainties, there can be no assurance
that the forward-looking information contained in this release will
occur.
< Financial Tables to Follow >
India Globalization Capital, Inc.
CONSOLIDATED BALANCE SHEETS (in thousands, except share
data) (Unaudited)
September 30,
2022
($)
March 31,
2022 ($)
ASSETS
Current assets:
Cash and cash equivalents
6,623
10,460
Accounts receivable, net
189
125
Short-term investments
193
-
Inventory
3,750
3,548
Deposits and advances
444
978
Total current assets
11,199
15,111
Intangible assets, net
952
917
Property, plant and equipment, net
8,470
9,419
Claims and advances
950
937
Operating lease asset
387
450
Total long-term assets
10,759
11,723
Total assets
21,958
26,834
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
456
981
Accrued liabilities and others
926
1,460
Total current liabilities
1,382
2,441
Long-term loans
142
144
Other liabilities
15
16
Operating lease liability
275
341
Total noncurrent liabilities
432
501
Total liabilities
1,814
2,942
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
Sept. 30, 2022, and March 31, 2022.
Common stock and additional paid-in
capital, $0.0001 par value: 150,000,000 shares authorized;
53,058,061 and 51,054,017 shares issued and outstanding as of Sept.
30, 2022, and March 31, 2022, respectively.
117,899
116,019
Accumulated other comprehensive loss
(3,369)
(2,968)
Accumulated deficit
(94,386)
(89,159)
Total stockholders’
equity
20,144
23,892
Total liabilities and stockholders’
equity
21,958
26,834
These financial statements should be read in
connection with the accompanying notes on Form 10-Q for the quarter
ended on Sept. 30, 2022 and filed with the SEC on November 1,
2022.
India Globalization Capital, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except loss per share and share data)
(Unaudited)
Three months ended September
30,
2022
($)
2021
($)
Revenue
202
56
Cost of revenue
(67)
(18)
Gross Profit
135
38
Selling, general and administrative
expenses
(1,855)
(4,110)
Research and development expenses
(768)
(276)
Operating loss
(2,488)
(4,348)
Impairment of investment
-
-
Other income, net
46
4
Loss before income taxes
(2,442)
(4,344)
Income tax expense/benefit
-
-
Net loss attributable to common
stockholders
(2,442)
(4,344)
Foreign currency translation
adjustments
(182)
20
Comprehensive loss
(2,624)
(4,324)
Loss per share attributable to common
stockholders:
Basic & diluted
$
(0.05)
$
(0.09)
Weighted-average number of shares used in
computing loss per share amounts:
52,194,098
49,948,930
These financial statements should be read in
connection with the accompanying notes on Form 10-Q for the quarter
ended on Sept. 30, 2022 and filed with the SEC on November 1,
2022.
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Claudia Grimaldi 301-983-0998
IGC Pharma (AMEX:IGC)
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