Artelo Biosciences Reports First Quarter Fiscal Year 2022 Financial Results and Provides Business Update
13 January 2022 - 12:30AM
Artelo Biosciences, Inc. (Nasdaq:
ARTL), a clinical stage pharmaceutical company developing
therapeutics that modulate lipid-signaling pathways, including the
endocannabinoid system, today reported financial and operating
results for the first quarter of its fiscal year ended November 30,
2021 and provided a business update.
Gregory D. Gorgas, President and Chief Executive
Officer of Artelo Biosciences, said, “We continue our Cancer
Appetite Recovery Study (CAReS), evaluating ART27.13 as a potential
treatment for cancer-related anorexia. The results of Phase 1 will
determine the safe and effective dose recommended for the Phase 2
portion of CAReS. We expect to complete patient enrollment in Phase
1 by the end of first quarter of calendar year 2022 and will
announce results immediately after all data is verified.”
Originally developed by AstraZeneca plc,
ART27.13 has been in five Phase 1 clinical studies including over
200 subjects where it demonstrated a statistically significant and
dose-dependent increase in body weight in healthy subjects.
Importantly, the changes in body weight were not associated with
fluid retention, and the distribution of the drug enables systemic
metabolic effects while minimizing central nervous system-mediated
toxicity. Artelo holds the exclusive license to develop
ART27.13 on a worldwide basis.
“With $26.4 million in cash and marketable
securities as of November 30, 2021,” Mr. Gorgas added, “We believe
we have the capital to achieve significant clinical and
non-clinical milestones into the second half of 2023. We maintain
our disciplined focus on significant value drivers as we move into
the new year and look forward to providing meaningful updates as
they occur.” First Quarter Fiscal
2022 Financial Results:
- Operating expenses for the three
months ended November 30, 2021 were $2.55 million compared to $1.44
million for the same period in 2020. The increase in operating
expenses for the three months ended November 30, 2021 were
primarily related to increases in stock-based compensation expense
and an increase in subcontractor expenditures relating to the
Company’s ART27.13 clinical trials.
- Net loss was approximately $2.55
million, $0.08 per basic and diluted share, for the three months
ended November 30, 2021 compared to a net loss of $1.44 million,
$0.14 per basic and diluted share, for the same period in
2020.
- As of November 30, 2021, the
Company had approximately $26.4 million in cash and marketable
securities, compared to $10.07 million as of August 31, 2021.
About ART27.13ART27.13 is a highly potent,
peripherally restricted synthetic, dual GPCR agonist believed to
target the cannabinoid receptors CB1/CB2, which has the potential
to increase appetite and food intake. Over 200 healthy subjects
participated in five Phase 1 studies with ART27.13, and the product
candidate is now being investigated in cancer patients over a
longer 12 week duration. Artelo is advancing ART27.13 as a
supportive care therapy for cancer patients suffering from anorexia
and weight loss where the current annual global market is estimated
to be valued in excess of $2 billion.
About CAReSThe Cancer Appetite
Recovery Study (CAReS) is a Phase 1/2 randomized,
placebo-controlled trial of the Company’s lead clinical program,
ART27.13, in patients with cancer anorexia and weight loss.
Anorexia, or the lack or loss of appetite in cancer patients, may
result from the cancer and/or its treatment with radiation or
chemotherapy. It is common for patients with cancer to lose weight.
Anorexia and the resulting weight loss can affect a patient’s
health, often weakening their immune system and causing discomfort
and dehydration. A weight loss of more than 5% can predicted a poor
outcome for cancer patients and a lower response to chemotherapy.
The Phase 1 portion of the CAReS study is designed to determine the
most effective and safest dose of ART27.13 that will be used in the
Phase 2 stage. The Phase 2 portion of the CAReS study is designed
to determine point estimates of activity of ART27.13 in terms of
lean body mass, weight gain, and improvement of anorexia. The study
is planned to enroll up to 24 patients in the Phase 1 and 25
participants in the Phase 2.(ISRCTN
registry: https://www.isrctn.com/ISRCTN15607817)
About Artelo BiosciencesArtelo
Biosciences, Inc. is a clinical stage pharmaceutical company
dedicated to the development and commercialization of proprietary
therapeutics that modulate lipid-signaling pathways, including the
endocannabinoid system. Artelo is advancing a portfolio of broadly
applicable product candidates designed to address significant unmet
needs in multiple diseases and conditions, including anorexia,
cancer, PTSD, pain, and inflammation. Led by proven pharmaceutical
executives collaborating with highly respected researchers and
technology experts, Artelo applies leading edge scientific,
regulatory, and commercial discipline to develop high-impact
therapies. More information is available
at www.artelobio.com and Twitter: @ArteloBio.
Forward Looking Statements
This press release contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and Private Securities Litigation Reform Act, as
amended, including those relating to Artelo’s product development,
clinical and regulatory timelines, market opportunity, competitive
position, possible or assumed future results of operations,
business strategies, potential growth opportunities and other
statement that are predictive in nature. These forward-looking
statements are based on current expectations, estimates, forecasts
and projections about the industry and markets in which we operate
and management’s current beliefs and assumptions. These statements
may be identified by the use of forward-looking expressions,
including, but not limited to, “expect,” “anticipate,” “intend,”
“plan,” “believe,” “estimate,” “potential,” “predict,” “project,”
“should,” “would” and similar expressions and the negatives of
those terms. These statements relate to future events or our
financial performance and involve known and unknown risks,
uncertainties, and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such factors include those set
forth in Artelo’s filings with the Securities and Exchange
Commission, including our ability to raise additional capital in
the future. Prospective investors are cautioned not to place undue
reliance on such forward-looking statements, which speak only as of
the date of this press release. Artelo undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise, except to the
extent required by applicable securities laws.
Investor Relations
Contact:Crescendo Communications, LLCTel:
212-671-1020Email: ARTL@crescendo-ir.com
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