Artelo Biosciences Reports Fiscal 2022 Year-End Financial Results and Provides Business Update
March 31 2023 - 8:00AM
Artelo Biosciences,
Inc. (
Nasdaq:ARTL), a clinical-stage
pharmaceutical company focused on modulating lipid-signaling
pathways to develop treatments for people living with cancer, pain,
and neurological conditions, today reported financial and operating
results for the fiscal year ended December 31, 2022 and provided a
business update.
“We achieved meaningful clinical progress throughout 2022,”
stated Gregory D. Gorgas, President and Chief Executive Officer of
Artelo Biosciences. “Importantly, we completed enrollment of the
first three cohorts in our Cancer Appetite Recovery Study (CAReS),
evaluating ART27.13 for the treatment of cancer-related anorexia
and weight loss. Given ART27.13’s better-than-expected safety
profile and absence of drug-related grade three or four toxicity,
we elected to advance to a fourth cohort at a 650-microgram dose.
Since enrollment of the fourth cohort is now complete, we are
awaiting the final patient’s results to be fully evaluable before
initiation of the Phase 2a stage of CAReS, which is anticipated in
April 2023.”
“We are well funded into the second half of 2024 and intend to
aggressively advance our product pipeline to develop new treatment
options for people suffering from cancer and other debilitating
diseases.”
Additional 2022 Business Highlights:
- Selected for an oral presentation
at the 32nd International Cannabinoid Research Society (ICRS)
Symposium. Artelo’s Vice President of Translational Sciences,
Saoirse O’Sullivan, presented pre-clinical data related to
ART26.12, the Company’s lead fatty acid binding protein 5 (FABP5)
inhibitor. The pre-clinical research showed that chronic, oral
treatment with ART26.12 was effective at both preventing and
treating both oxaliplatin and paclitaxel-induced pain sensitivity
without any sedating effects. Additionally, ART26.12 minimized the
acute weight loss caused by oxaliplatin, supporting further
development in neuropathy associated with chemotherapy and other
neuropathies.
- Published pre-clinical results with
one of the Company’s novel FABP5 inhibitors which selectively
reduced activity in an area of the brain associated with anxiety
indicating that modulation of the FABP5 system may serve as a
promising target for the development of novel anxiolytics. This
research was led by Taygun C. Uzuneser, Ph.D., and Steven R.
Laviolette, Ph.D., both of the University of Western Ontario,
London, Ontario, and was published in the journal Cerebral
Cortex.
- Reported positive pre-clinical
results of ART27.13 showing protection of human muscle cells from
cancer-induced muscle degeneration (cachexia) via a
CB2 mediated mechanism of action.
- Entered into a second collaboration
with Richard K. Porter, Ph.D., of the School of Biochemistry &
Immunology at Trinity College Dublin, Ireland to investigate the
molecular basis of FABP inhibition in cancer and the potential of
the ART26.12 platform for the treatment of various tumors.
- Announced United Kingdom’s Home
Office had classified the Company’s lead clinical
cannabinoid, ART27.13, as “non-controlled” and, therefore, is
no longer considered a Schedule 1 controlled substance. This is
expected to streamline onboarding of additional clinical sites in
the U.K. for expansion of the Phase 2a stage of CAReS, accelerate
acceptance by patients, and enhance the commercial potential of
ART27.13.
- Received Notice of Allowance for
Method-of-Use Patent in the United States for ART12.11, a
proprietary cocrystal of cannabidiol (CBD).
Fiscal 2022
Year-End Financial Results:
- Operating expenses for the year
ended December 31, 2022 were $10.3 million compared to $4.0 million
for the four months ended December 31, 2021, and $7.4 million for
the year ended August 31, 2021. The increase in operating expenses
for the year ended December 31, 2022 were primarily related to the
increase in general and administrative fees and research and
development expenses.
- Net loss was
approximately $10.1 million, or $3.56 per basic and diluted share
for the year ended December 31, 2022 compared to a net loss of $4.0
million, or $1.81 per basic and diluted share for the four months
ended December 31, 2021, and $7.4 million or $5.97 per basic and
diluted share for the year ended August 31, 2021.
- As of December
31, 2022, the Company had approximately $17.5 million in cash and
marketable securities, compared to $25.6 million as of December 31,
2021 and $10.0 million as of August 31, 2021.
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, anxiety, pain, neuropathy, and inflammation. Led by proven
biopharmaceutical executives collaborating with highly respected
researchers and technology experts, the company applies leading
edge scientific, regulatory, and commercial discipline to develop
high-impact therapies. More information is available
at www.artelobio.com and Twitter: @ArteloBio.
About ART27.13ART27.13 is a highly potent,
peripherally restricted synthetic, dual G-Protein Couple Receptor
agonist believed to target the cannabinoid receptors CB1 and
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 1b/2a 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 1b portion of the CAReS study
is designed to determine the most effective and safest dose of
ART27.13 for dosing in the Phase 2a stage. The Phase 2a portion of
the CAReS study is designed to determine estimates of activity of
ART27.13 in terms of lean body mass, weight gain, and improvement
of anorexia. (ISRCTN
registry: https://www.isrctn.com/ISRCTN15607817)
Forward Looking StatementsThis 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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