IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC),
a clinical-stage pharmaceutical company, today announced its
financial results for the fiscal year ended March 31, 2023 (“Fiscal
2023”).
Full Fiscal Year Highlights and Events Subsequent
Thereto
- On July 7, 2023, the Company announced a $12 million revolving
line of credit from the Hong Kong Branch of O-Bank Co. Ltd.
(“O-Bank” or the “Bank”). This funding will support the working
capital needs of the Company, primarily related to Alzheimer’s
research.
- On July 6, 2023, the Company announced a $3 million private
placement of its common stock. IGC received strategic investments
from four investment funds managed by Bradbury Asset Management
(Hong Kong) Limited (“Bradbury”) along with contributions from
three additional investors, resulting in approximately $3 million
in gross proceeds, further strengthening IGC’s working capital. The
transaction had no warrants or derivatives, and the shares were
unregistered.
- On June 6, 2023, the Commissioner of Patents, Canada, granted
the Company its patent filing on the use of cannabinoids in the
treatment of seizures (IGC-501) (Notice of Allowance). The
formulation also received an intent to grant from the European
Patent Office, protecting the formulation in the U.S., Canada, and
certain European countries.
- On March 8, 2023, the Company filed a provisional patent
application with the USPTO titled “Composition, Synthesis, and
Medical Use of Hybrid Cannabinoid”.
- On January 4, 2023, Health Canada gave the Company approval to
begin its trial in Canada (No-objection letter). The Company is
currently in Phase 2B safety and efficacy clinical trials for its
lead drug candidate, IGC-AD1. The trial, which commenced in
December of 2022, will enroll 146 total patients across an
anticipated 13-15 trial sites with a target enrolment of between 15
to 20 patients per month. The Company is targeting completion of
its Phase-2 trial in the first quarter of calendar 2024. In
pre-clinical studies on Alzheimer’s cell lines, IGC-AD1 has
demonstrated efficacy in reducing plaques and tangles, two
important hallmarks of Alzheimer’s, and in Phase 1, trials in
reducing neuropsychiatric symptoms associated with dementia in
Alzheimer’s disease, such as agitation.
- On September 20, 2022, the Company received a patent from the
USPTO (#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 August 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 based on some of this research.
- On June 20, 2022, the Company announced that it had acquired
rights to TGR-63, a pre-clinical molecule that exhibits an
impressive affinity for reducing neurotoxicity in Alzheimer’s cell
lines. Neurotoxicity causes cell dysfunction and death in
Alzheimer’s disease. If shown to be efficacious, in AD cell lines,
in halting this process, this inhibitor has the potential to treat
Alzheimer’s disease by ameliorating Aβ plaques. Pre-clinical
testing demonstrates that TGR-63 holds the potential to ameliorate
amyloid plaque, a key hallmark of Alzheimer’s disease. Behavioral
tests with Alzheimer’s (APP/PS1) mice show that TGR-63 can rescue
neuronal cells from amyloid toxicity and minimize learning
deficiency, memory impairment & cognitive decline.
- On June 7, 2022, the Company received a patent from the USPTO
(#11,351,152) titled “Method and Composition for Treating Seizures
Disorders.” The patent relates to compositions and methods for
treating multiple types of seizure disorders and epilepsy in humans
and animals using a combination of CBD with other compounds. The
combination is intended to reduce side effects caused by hydantoin
anticonvulsant drugs by reducing the dosing of anticonvulsant drugs
in humans, dogs, and cats.
- We have filed forty-one (41) patent applications and secured
nine patents, including control of four in the Alzheimer’s space.
The Company is moving towards monetizing the patent portfolio as
soon as commercialization begins.
Ram Mukunda, CEO of IGC, commented, “Fiscal 2023 was
characterized by remarkable growth and progress as we continue to
advance our drug formulations through FDA trials. IGC-AD1 is
delivering strong results as it progresses through Phase 2B trials.
We are delighted with the positive headway we are making in
clinical trials, and we remain confident in the potential of
IGC-AD1 to be a groundbreaking therapy, with the potential to treat
Alzheimer’s and to manage devastating symptoms that separate
families, increase admissions to nursing homes, and drive the cost
of Alzheimer’s care. In addition to IGC-AD1, we continue to
identify and acquire drug formulations that we believe have the
potential to treat the symptoms brought on by a variety of chronic
illnesses. Moreover, we continue to expand the market presence of
our consumer products, as evidenced by a 129% increase in revenue
compared to last year. Overall, we are very pleased with the
progress we have made in Fiscal 2023 and believe that we are
uniquely and advantageously positioned with a vertically integrated
business model to continue driving growth through fiscal 2024 and
beyond.”
Financial Summary
In Fiscal 2023, the Company generated approximately $911,000 in
revenue, representing an increase of 129% compared to $397,000
generated in the fiscal year ended March 31, 2022 (“Fiscal 2022).
The primary source of revenue was the Life Sciences segment and the
Company’s formulations as white-labeled manufactured products and
sales of branded holistic women’s health care products, among
others.
The Company reported Selling, general, and administrative
(“SG&A”) expenses for Fiscal 2023 of approximately $8.5
million, representing a decrease of approximately $4.7 million, or
36%, compared to the $13.2 million recorded in Fiscal 2022. This
decline in SG&A expenses are attributable to a reduction in
one-time expenses of approximately $4.2 million and a decrease of
approximately $500 thousand in compensation, legal and marketing
expenses, net realizable value (“NRV”) adjustments, and other
SG&A expenses.
In Fiscal 2023, the Company reported research and development
(“R&D”) expenses of approximately $3.5 million, representing an
increase of $1.2 million or 49% compared to approximately $2.3
million in Fiscal 2022. The increase in R&D expenses is
primarily attributed to the progression of Phase 2 trials on
IGC-AD1 and pre-clinical studies on TGR-63, indicating the
Company’s dedication to advancing its product pipeline. As the
development of TGR-63 and the Phase 2B trial on Alzheimer’s gain
momentum, the Company anticipates further increases in R&D
expenses attributable to the progression of Phase 2 trials on
IGC-AD1 and pre-clinical studies on TGR-63. We anticipate increased
R&D expenses as the development of TGR-63 and the Phase 2B
trial on Alzheimer’s pick up more momentum.
Net loss for Fiscal 2023 was approximately $11.5 million or
$0.22 per share, compared to approximately $15 million or $0.30 per
share for Fiscal 2022.
About IGC Pharma, Inc.
IGC Pharma, Inc., (dba IGC) develops advanced cannabinoid-based
formulations for treating diseases and conditions, including, but
not limited to, Alzheimer’s disease, period cramps
(“dysmenorrhea”), premenstrual syndrome (“PMS”), and chronic pain.
IGC has two investigational drug assets targeting Alzheimer’s
disease, IGC-AD1 and TGR-63, which have demonstrated in Alzheimer’s
cell lines the potential to be effective in suppressing or
ameliorating key hallmarks of Alzheimer’s disease, such as plaques
or tangles. IGC-AD1 is a low-dose tetrahydrocannabinol (“THC”)
based formulation that is currently in a 146-person Phase 2
clinical trial for agitation in dementia due to Alzheimer’s
(clinicaltrials.gov, NCT05543681). IGC Pharma, Inc., also markets a
wellness brand, Holief™, that targets women experiencing
premenstrual syndrome and menstrual cramps.
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 U.S. Securities and Exchange
Commission (“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 July 7, 2023, 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>
IGC Pharma, Inc.
CONSOLIDATED BALANCE
SHEETS
(in thousands, except share
data)
March 31,
2023
($)
March 31,
2022
($)
ASSETS
Current assets:
Cash and cash equivalents
3,196
10,460
Accounts receivable, net
107
125
Short term investments
154
-
Inventory
2,651
3,548
Deposits and advances
358
978
Total current assets
6,466
15,111
Non-current assets:
Intangible assets, net
1,170
917
Property, plant and equipment, net
8,213
9,419
Claims and advances
1,003
937
Operating lease asset
326
450
Total non-current assets
10,712
11,723
Total assets
17,178
26,834
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
530
981
Accrued liabilities and others
1,368
1,460
Total current liabilities
1,898
2,441
Non-current liabilities:
Long-term loans
141
144
Other liabilities
21
16
Operating lease liability
207
341
Total non-current liabilities
369
501
Total liabilities
2,267
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
March 31, 2023, or March 31, 2022.
Common stock and additional paid-in
capital, $0.0001 par value: 150,000,000 shares authorized;
53,077,436 and 51,054,017 shares issued and outstanding as of March
31, 2023, and March 31, 2022, respectively.
118,965
116,019
Accumulated other comprehensive loss
(3,389
)
(2,968
)
Accumulated deficit
(100,665
)
(89,159
)
Total stockholders’ equity
14,911
23,892
Total liabilities and stockholders’
equity
17,178
26,834
These financial statements should be read in
connection with the accompanying notes on Form 10-K for fiscal year
ending March 31, 2023, filed with the SEC on July 7, 2023.
IGC Pharma, Inc.
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except loss per
share and share data)
Years Ended March 31,
2023
($)
2022
($)
Revenue
911
397
Cost of revenue
(469
)
(203
)
Gross profit
442
194
Selling, general and administrative
expenses
(8,552
)
(13,292
)
Research and development expenses
(3,461
)
(2,330
)
Operating loss
(11,571
)
(15,428
)
Impairment of investment
-
(49
)
Other income, net
65
461
Loss before income taxes
(11,506
)
(15,016
)
Income tax expense/benefit
-
-
Net loss attributable to common
stockholders
(11,506
)
(15,016
)
Foreign currency translation
adjustments
(421
)
(194
)
Comprehensive loss
(11,927
)
(15,210
)
Net loss per share attributable to
common stockholders:
Basic and diluted
$
(0.22
)
$
(0.30
)
Weighted-average number of shares used in
computing loss per share amounts:
52,576,258
49,991,631
These financial statements should be read in
connection with the accompanying notes on Form 10-K for fiscal year
ending March 31, 2023, filed with the SEC on July 7, 2023.
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version on businesswire.com: https://www.businesswire.com/news/home/20230712888667/en/
Walter Frank IMS Investor Relations (203) 972-9200
igc@imsinvestorrelations.com
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