- IGC-ADI addressing agitation in dementia due to Alzheimer’s
progresses in Phase 2 Trial
- Company focuses on advancing the development of an expanded
IP portfolio targeting Alzheimer’s
IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC)
today announced its financial results for the second fiscal quarter
of 2024 ended September 30, 2023 (Q2 FY2024).
Q2 FY2024 Highlights
- Revenue in Q2 FY2024 increased 44% to approximately $291,000
compared to the same quarter in FY2023 at roughly $202,000. In the
first six months of FY2024, revenue doubled to about $846,000 from
about $414,000 compared to the prior year’s six-month period. IGC’s
revenue was primarily generated from our over-the-counter products
and services provided at our Vancouver, Washington facility, which
is being prepared for a potential Phase 3 trial and
commercialization of our investigational new drug, IGC-AD1.
- IGC-AD1, the Company’s flagship formulation in trials to
address agitation in dementia due to Alzheimer’s, continues to make
strides in its multi-site Phase 2 trial (NCT05543681, IND 146069).
The Company continues to drive progress with ten sites in the
United States and Canada, currently conducting the trial. On July
11, 2023, the Canadian Intellectual Property Office issued a patent
(#2,961,410) to the Company titled “Cannabinoid Composition and
Method for Treating Pain”. The patent relates to compositions and
methods for treating multiple types of seizure disorders in humans
using a combination of cannabinoids with other compounds. Subject
to further research and study, the combination may be used for
relieving pain in patients with psoriatic arthritis, fibromyalgia,
scleroderma, shingles, and related pain-generating conditions.
Financial Summary
During the three months ended September 30, 3023, the Company
generated approximately $291,000 in revenue, representing an
increase of 44% compared to the approximately $202,000 generated
during the three months ended September 30, 2022. The primary
source of revenue was the Company’s Life Sciences division.
The Company reported Selling, General, and Administrative
(“SG&A”) expenses during the three months ended September 30,
2023, of approximately $1.4 million, representing a decrease of
approximately $458,000, or 25%, compared to the approximately $1.9
million recorded for the three months ended September 30, 2022. The
reduction in SG&A expenses is attributed to a decrease in
operational and corporate expenses.
During the three months ended September 30, 2023, the Company
reported Research and Development (“R&D”) expenses of
approximately $1.3 million, representing an increase of
approximately $500,000 or 65% compared to approximately $768,000
during the three months ended September 30, 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. Although there can be no assurance, we anticipate increased
R&D expenses as the development of our other small molecule
assets targeting Alzheimer’s and the Phase 2B trial on Alzheimer’s
expand.
Net loss for the three months ended September 30, 2023, was
approximately $2.5 million or $0.05 per share, compared to
approximately $2.4 million or $0.05 per share for three months
ended September 30, 2022.
Management Commentary
Ram Mukunda, CEO of IGC Pharma, commented, “We continue to make
strides advancing our numerous drug formulations, with our flagship
asset, IGC-AD1, currently in Phase 2 trials for the treatment of
agitation caused by symptoms of Alzheimer’s disease. Including
IGC-AD1, we have five drug assets, TGR-63, LMP, IGC-1C, and IGC-M3,
all of which have shown pre-clinical efficacy in targeting
Alzheimer’s disease. They are at various stages of development. In
addition to our traditional trial methods, we are also exploring
the capabilities of generative artificial intelligence, or AI, as
it relates to analyzing the myriad of data produced by a trial and
maximizing the efficiency and minimizing the time needed to conduct
clinical trials. For this, we entered a master cooperation
agreement with a leading university in Colombia, South America,
with expertise in AI and pharma.”
“We are pleased with the progress that we’ve made this quarter,
and we believe that we are well positioned with strategic
partnerships and a clear path to bring solutions to market for the
treatment of Alzheimer’s," Mr. Mukunda concluded.
About IGC Pharma (dba IGC):
At IGC Pharma, we are pioneering innovative solutions to combat
Alzheimer’s disease and related challenges. Our portfolio comprises
five assets, each at distinct stages of development, all with a
singular mission — to transform the landscape of Alzheimer’s
treatment. IGC-AD1and LMP: Targeting 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), representing a critical step in
our journey to deliver impactful therapies. TGR-63 targets Aβ
plaque, where we seek to disrupt the progression of Alzheimer’s
disease. IGC-M3 targets both Aβ plaques and tau, two Alzheimer’s
defining hallmarks, with the potential to create a profound impact.
IGC-1C: Targeting tau and neurofibrillary tangles, IGC-1C
represents a forward-thinking approach to Alzheimer’s therapy. In
parallel, IGC Pharma is at the forefront of Generative AI
development, with projects spanning clinical trials, molecule
discovery and analysis, and drug interactions.
Forward-looking Statements
This press release contains forward-looking statements. These
forward-looking statements are mainly based on IGC’s expectations
and are subject to several risks and uncertainties, some 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; 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.
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.
CONSOLIDATED BALANCE
SHEETS
(in thousands, except share
data)
(Unaudited)
September 30, 2023
($)
March 31,
2023 ($)
ASSETS
Current assets:
Cash and cash equivalents
3,026
3,196
Accounts receivable, net
137
107
Short term investments
98
154
Inventory
2,636
2,651
Deposits and advances
220
358
Total current assets
6,117
6,466
Non-current assets:
Intangible assets, net
1,181
1,170
Property, plant, and equipment, net
7,947
8,213
Claims and advances
998
1,003
Operating lease asset
263
326
Total non-current assets
10,389
10,712
Total assets
16,506
17,178
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
549
530
Accrued liabilities and others
1,557
1,368
Total current liabilities
2,106
1,898
Non-current liabilities:
Long-term loans
139
141
Other liabilities
17
21
Operating lease liability
146
207
Total non-current liabilities
302
369
Total liabilities
2,408
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
September 30, 2023, and March 31, 2023.
Common stock and additional paid-in
capital, $0.0001 par value: 150,000,000 shares authorized;
63,706,939 and 53,077,436 shares issued and outstanding as of
September 30, 2023, and March 31, 2023, respectively.
122,732
118,965
Accumulated other comprehensive loss
(3,443)
(3,389)
Accumulated deficit
(105,191)
(100,665)
Total stockholders’ equity
14,098
14,911
Total liabilities and stockholders’
equity
16,506
17,178
These financial statements should be read in
connection with the accompanying notes on Form 10-Q for the quarter
ended September 30, 2023, filed with the SEC on November 09,
2023.
IGC Pharma, Inc.
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except loss per
share and share data)
(Unaudited)
Three months ended
September 30,
Six months ended
September 30,
2023
2022
2023
2022
($)
($)
($)
($)
Revenue
291
202
846
414
Cost of revenue
(117)
(67)
(417)
(137)
Gross profit
174
135
429
277
Selling, General and Administrative
expenses
(1,397)
(1,855)
(3,044)
(3,405)
Research and development expenses
(1,268)
(768)
(2,015)
(2,162)
Operating loss
(2,491)
(2,488)
(4,630)
(5,290)
Other income, net
40
46
104
63
Loss before income taxes
(2,451)
(2,442)
(4,526)
(5,227)
Income tax expense/benefit
-
-
-
-
Net loss attributable to common
stockholders
(2,451)
(2,442)
(4,526)
(5,227)
Foreign currency translation
adjustments
(63)
(182)
(54)
(401)
Comprehensive loss
(2,514)
(2,624)
(4,580)
(5,628)
Net loss per share attributable to
common stockholders:
Basic and diluted
$
(0.05)
(0.05)
(0.08)
(0.10)
Weighted-average number of shares used in
computing net loss per share amounts:
54,301,087
52,194,098
53,695,912
52,082,096
These financial statements should be read in
connection with the accompanying notes on Form 10-Q for the quarter
ended September 30, 2023, and filed with the SEC on November 09,
2023.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231113501857/en/
Walter Frank IMS Investor Relations (203) 972-9200
igc@imsinvestorrelations.com
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