India Globalization Capital, Inc. (NYSE American: IGC) announces
its financial results for the three months ended September 30,
2021, which is the second quarter of the Company’s 2022 fiscal
year.
The highlights for the quarter are:
- As previously disclosed, on September 7, 2021, the Company
announced the completion of its Phase 1 clinical trial on IGC’s
tetrahydrocannabinol (“THC”) based investigational new drug,
IGC-AD1, intended to alleviate certain symptoms of individuals who
have Alzheimer’s disease. The primary endpoint of this Phase 1
trial was safety and tolerability. Based on this study and subject
to FDA concurrence the cannabis-based investigational drug IGC-AD1
was generally safe and well-tolerated by the Alzheimer’s trial
participants. The trial’s secondary endpoints including
pharmacokinetics, genotyping, Neuropsychiatric Inventory (NPI), and
measurement of suicide severity, have also been completed. We
expect to report this data as it becomes available and after
submission to the FDA.
- The Company is preparing an INDA submission to the FDA for a
Phase 2/3 trial for the use of IGC-AD1 to address symptoms
associated with Alzheimer’s disease. The Company believes that this
may be the first such filing using low doses of a natural
phytocannabinoid, THC, on patients suffering from Alzheimer’s
disease.
- On September 17, 2021, the Company filed a provisional patent
application (IGC-513) with the United States Patent and Trademark
Office (“USPTO”) for addressing Neuropsychiatric Symptoms (NPS)
associated with dementia using a dosing pattern of IGC-AD1 that was
employed in the recently completed Phase 1 trial on patients
suffering from Alzheimer's disease. The patent filing specifically
addresses reducing the overall presence and severity of NPS in
dementia as measured by the NPI, a tool that assesses the presence
of twelve symptoms such as delusion, hallucination,
agitation/aggression, depression, anxiety, elation/euphoria,
apathy, disinhibition, irritability, aberrant motor behavior, sleep
disorder, appetite and eating disorders.
- On October 5, 2021, the Company received a Good Manufacturing
Practice (GMP) certificate for its hemp processing facility in
Vancouver Washington where it manufactures tinctures, lotions,
gummies and other topical and consumable products.
- During the six months ended September 30, 2021, the Company
raised approximately $4.1 million of net proceeds from the issuance
of equity stock. The Company had entered an “at the market” (“ATM”)
offering pursuant to a Sales Agreement entered on January 13, 2021,
with The Benchmark Company, LLC for the issuance and sale of up to
$75,000,000 of the Company’s shares of common stock, par value
$0.0001 per share.
Revenue in the quarters ended September 30, 2021, and September
30, 2020, were primarily derived from our Life Sciences segment,
which involved sales of products such as lotion, gummies, and
alcohol-based hand sanitizers, among others. Revenue was
approximately $56 thousand and $125 thousand for the three months
ended September 30, 2021, and the three months ended September 30,
2020, respectively. Revenue in our Infrastructure segment for the
three months ended September 30, 2021, was $3 thousand and $67
thousand in the three months ended September 30, 2020. The revenue
relates to the execution of a construction contract. Primarily due
to COVID-19, we have limited visibility on when either of our
segments will stabilize, generate significant revenue, and become
predictable. We expect volatility in both segments in the
foreseeable future.
Selling, General and Administrative (SG&A) expenses
increased by approximately $2.6 million to approximately $4.1
million for the three months ended September 30, 2021, from
approximately $1.48 million for the three months ended September
30, 2020. The $2.6 million increase in SG&A is attributable to
the following: approximately $1.7 million to a provision for stolen
inventory at our vendor’s premises, approximately $352 thousand for
previously announced legal settlements and associated legal
expenses, approximately $125 thousand for an IRS tax penalty, and
non-cash increases of $223 thousand and $55 thousand for common
stock-based compensation and depreciation respectively. The
remaining increase of about $ 153 thousand is related to marketing
and other operating expenses.
Research and Development (“R&D”) expenses were attributed to
conducting the Phase 1 trial on patients suffering from Alzheimer’s
disease and product research in our Life Sciences segment. The
R&D expenses for the three months ended September 30, 2021, are
approximately $276 thousand and approximately $219 thousand for the
three months ended September 30, 2020. We expect R&D expenses
to increase with progression in trials on IGC-AD1, subject to FDA
approval.
Net loss for the three months ended September 30, 2021, was
approximately $4.3 million or ($0.08) per share, compared to
approximately $1.65 million or ($0.04) per share for the three
months ended September 30, 2020.
About IGC: IGC operates two lines of business: (i)
infrastructure and (ii) life sciences. The Company is based in
Potomac, Maryland, U.S.A. social media: www.igcinc.us /
www.igcpharma.com
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.
For the next several years, our success is highly correlated
primarily with the successful outcome of our clinical trials and
the recovery of the world and local economies following the
COVID-19 pandemic, and, secondarily, on the sale of our products
and services candidates. IGC may not be able to complete human
trials on our investigational drug candidates, or, once conducted,
the results of human trials testing may not be favorable or as
anticipated. Our projections and investments anticipate stable
pricing, which may not hold out over the next several years, and
certain regulatory changes, specifically in states where medical
cannabis has been, is, or will be legalized and the diseases which
we anticipate our products will target are approved conditions for
treatment or usage with cannabis/cannabinoids. We may not be able
to protect our intellectual property adequately or receive patents.
We may not receive regulatory approval for our products, or trials.
An additional risk factor worth highlighting specifically related
to patent licensing is that the patent applications we have
licensed may not be granted by the USPTO, even if the Company is in
full compliance with USPTO requirements. We may not have adequate
resources including financial resources, to successfully conduct
all requisite clinical trials, to bring a product to market, or to
pay applicable maintenance fees over time. We may not be able to
successfully commercialize our products even if they are successful
and receive regulatory approval. Failure or delay with respect to
any of the factors above could have a material adverse effect on
our business, future results of operations, our stock price, and
our financial condition. Actual results could differ materially
from these forward-looking statements as a result of, the factors
described both herein and in IGC’s SEC filings. IGC incorporates by
reference the Risk Factors identified in its Annual Report on Form
10-K filed with the SEC on June 14, 2021, Quarterly Reports on Form
10-Q filed with the SEC on August 11, 2021 and October 29, 2021, 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 in fact
occur.
< Financial Tables to Follow>
India Globalization Capital,
Inc.
CONSOLIDATED BALANCE
SHEETS
(in thousands, except share
data)
September 30,
2021
($)
March 31, 2021
($)
ASSETS
Current assets:
Cash and cash equivalents
14,399
14,548
Accounts receivable, net
138
175
Inventory
5,498
5,478
Non-Marketable securities
-
80
Deposits and advances
1,669
3,236
Total current assets
21,704
23,517
Intangible assets, net
411
407
Property, plant and equipment, net
10,589
10,840
Non-Marketable securities
11
12
Claims and advances
611
603
Operating lease asset
510
488
Total long-term assets
12,132
12,350
Total assets
33,836
35,867
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
418
476
Accrued liabilities and others
1,594
1,588
Short-term loans
3
304
Total current liabilities
2,015
2,368
Long-term loans
146
276
Other liabilities
15
15
Operating lease liability
404
405
Total non-current liabilities
565
696
Total liabilities
2,580
3,064
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
September 30, 2021 and March 31, 2021.
-
-
Common stock and additional paid-in
capital, $0.0001 par value: 150,000,000 shares authorized;
51,041,017 and 47,827,273 shares issued and outstanding as of
September 30, 2021 and March 31, 2021, respectively.
114,371
109,720
Accumulated other comprehensive loss
(2,840
)
(2,774
)
Accumulated deficit
(80,275
)
(74,143
)
Total stockholders' equity
31,256
32,803
Total liabilities and stockholders'
equity
33,836
35,867
These financial statements should be read in
connection with the accompanying notes on Form 10-Q for the quarter
ended September 30, 2021, filed with the SEC on October 29,
2021.
India Globalization Capital,
Inc.
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except loss per
share and share data)
Three months ended September
30,
2021
($)
2020
($)
Revenue
56
125
Cost of revenue
(18
)
(99
)
Gross Profit
38
26
Selling, general and administrative
expenses
(4,110
)
(1,483
)
Research and development expenses
(276
)
(219
)
Operating loss
(4,348
)
(1,676
)
Impairment of investment
-
-
Other income, net
4
19
Loss before income taxes
(4,344
)
(1,657
)
Net loss attributable to common
stockholders
(4,344
)
(1,657
)
Foreign currency translation
adjustments
20
142
Comprehensive loss
(4,324
)
(1,515
)
Loss per share attributable to common
stockholders:
Basic & diluted
$
(0.09
)
$
(0.04
)
Weighted-average number of shares used in
computing loss per share amounts:
49,948,930
41,244,109
These financial statements should be read in
connection with the accompanying notes on Form 10-Q for the quarter
ended September 30, 2021, filed with the SEC on October 29,
2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20211029005572/en/
Claudia Grimaldi 301-983-0998
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