Artelo Biosciences Reports Fiscal 2021 Year-End Financial Results and Provides Business Update
30 November 2021 - 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 fiscal year ended August 31, 2021 and provided a
business update.
“We achieved significant progress throughout the
past year, both clinically and operationally,” stated Gregory D.
Gorgas, President and Chief Executive Officer of Artelo
Biosciences. “Importantly, we initiated and continue to enroll
patients into our Cancer Appetite Recovery (CAReS) Study,
evaluating ART27.13 as a potential treatment for cancer-related
anorexia. We expect to report Phase 1 data from our CAReS study
first quarter of 2022 with randomized Phase 2 data anticipated in
the second half of next year.”
“In addition, we strengthened our balance sheet
with additional capital raised through our at-the-market equity
offering, resulting in more than $26.8 million in cash and
marketable securities on a pro-forma basis as of November 15,
2021,” added Mr. Gorgas. “With funding well into 2023, we expect to
reach meaningful clinical and developmental milestones, including
complete data readout from our CAReS study as well as initiation of
preclinical research to enable the start of human trials for both
our ART26.12 cancer program and ART12.11, our proprietary cocrystal
of cannabidiol.”
Additional 2021 Corporate Highlights Include:
- Filed patent application for new
solid formulation of ART27.13 with the UK Patent Office
- Entered research collaboration with
Trinity College Dublin to investigate ART27.13 for the treatment of
cancer cachexia
- Presented two posters featuring
ART27.13 and ART12.11 at the 31st Annual International Cannabinoid
Research Society Symposium
- Announced
publication of study results comparing the pharmacological effects
of plant-derived versus synthetic cannabidiol in human cell
lines
- Filed new patent application
covering new generation three inhibitors of Fatty Acid Binding
Protein 5 chemistries
- Awarded a Mitacs Accelerate
Canadian government grant with University of Western Ontario; grant
expected to fund 50% of research costs evaluating ART26.12 as a
potential treatment for anxiety disorders
- Announced positive pre-clinical
data associated with Artelo’s proprietary CBD cocrystal, ART12.11,
showing potential pharmacodynamic interactions of co-administration
of cannabidiol (CBD) and tetramethylpyrazine (TMP) in cell-based
models of cancer
Fiscal 2021 Year
End Financial Results:
- Operating expenses for the year
ended August 31, 2021 were $7,441,155 compared to $4,685,775 for
the same period in 2020. The increase in operating expenses for the
year ended August 31, 2021 were primarily related to the increase
in general and administrative fees and research and development
expenses.
- Net loss was approximately
$7,436,760, or $0.40 per basic and diluted share for the year ended
August 31, 2021 compared to a net loss of $4,654,862, or $1.26 per
basic and diluted share for the year ended August 31, 2020.
- As of August 31, 2021, the Company
had approximately $10,065,408 in cash and marketable securities,
compared to $2,142,072 as of August 31, 2020.
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. 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 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 Biosciences
Artelo Biosciences, Inc. is a clinical stage
pharmaceutical company dedicated to the development and
commercialization of proprietary therapeutics that target
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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