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 four month transitional period from September 1,
2021 to December 31, 2021 and provided a business update. The
reporting of this four-month period and the concurrent filing of
its Form 10-KT reflects the Company’s previously disclosed change
in its fiscal year end from August 31 to December 31.
“We achieved a number of important milestones in
2021 and look forward to multiple data readouts in 2022,” stated
Gregory D. Gorgas, President and Chief Executive Officer of Artelo
Biosciences. “We currently expect to report initial Phase 1 data
from our Cancer Appetite Recovery (CAReS) study evaluating ART27.13
as a potential treatment for cancer-related anorexia in the first
half of 2022 and to report randomized Phase 2 data in the second
half of 2022. Importantly, the United Kingdom’s Home Office
recently classified ART27.13, as a “non-controlled” substance. This
new ruling not only streamlines the addition of clinical sites in
the U.K. and accelerates patient enrollment, it also enhances the
overall commercial potential of ART27.13.”
“At the same time,” Mr. Gorgas added, “we
continue to advance both our ART26.12 cancer program and ART12.11,
our patented cocrystal of cannabidiol (CBD). With cash on hand
expected to support operations into the second half of 2023, we
expect to reach meaningful clinical and developmental milestones,
namely, the complete data readout from our CAReS study, as well as
the progress of preclinical research supporting the initiation of
human trials for both ART26.12 and ART12.11.”
December 31, 2021
Year End
Financial Results:
Operating expenses for the four months ended
December 31, 2021, were $4.0 million compared to $2.1 million for
the same period in 2020. The increase in operating expenses for the
four months ended December 31, 2021, was primarily related to
increases in payroll and stock-based compensation and an increase
in subcontractor expenditures relating to the Company’s ART27.13
clinical trials.
Net loss was approximately $4.0 million, or
$0.12 per basic and diluted share, for the four months ended
December 31, 2021, compared to a net loss of $2.1 million, or $0.18
per basic and diluted share, for the four months ended December 31,
2020.
As of December 31, 2021, the Company had approximately $25.6
million in cash and investments, compared to $10.1 million as of
December 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 predict 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 for dosage 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 developing 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
Source: Artelo Biosciences
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