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 three months ended
September 30, 2022 and provided a business update.
“Based on ART27.13’s favorable safety profile to date, the Phase
1b Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 for
the treatment of cancer-related anorexia and weight loss was
expanded to include a fourth, higher dose cohort earlier this year.
This final cohort is nearly fully enrolled. Once clinical results
are evaluated, we expect to commence enrollment of our Phase 2a
clinical trial near year-end,” stated Gregory D. Gorgas, President
and Chief Executive Officer of Artelo Biosciences.
“With over $19.5 million in cash and investments as of September
30, 2022, we expect to fund operations through the first half of
2024 and, thus, support the achievement of key clinical and
preclinical milestones,” added Mr. Gorgas.
Other Business Highlights
Promising Non-clinical Data for Multiple Potential Uses
from Artelo’s Fatty Acid Binding Protein 5 (FABP5)
Platform
At the International Cannabinoid Research Society’s annual
meeting in Galway, Ireland, June 26-30, 2022, Artelo shared data
from multiple non-clinical animal research studies with ART26.12,
its lead FABP5 inhibitor, indicating that chronic, oral
administration was effective at preventing and treating both
oxalplatin- and paclitaxel-induced pain sensitivity without any
sedating effects. These findings support further development of
ART26.12 in neuropathies, including neuropathy associated with
chemotherapy, which represents a significant unmet need for which
there are no approved treatments in the US, UK, or Europe. With
regulatory enabling research well underway, Artelo anticipates
filing an Investigational New Drug application with the FDA late
next year.
In addition to the research with ART26.12, Artelo reported
positive non-clinical results from one of its other novel FABP5
inhibitors, which suggests that the inhibition of FABP5 can be a
promising neurobiological approach for the development of
anxiety-inhibiting pharmacotherapies. Data from this research are
expected to be shared at the Society for Neuroscience annual
meeting in San Diego November 12-16, 2022 by Steven Laviolette, PhD
whose research was conducted at the University of Western Ontario,
Canada.
Financial Results Ended September
30, 2022
Operating expenses for the three months ended September 30,
2022, were $2.4 million compared to $2.2 million for the same
period in 2021. The increase in operating expenses for the three
months ended September 30, 2022, was primarily related to increases
in payroll and in subcontractor expenditures relating to the CAReS
trial.
Net loss was approximately $2.3 million, or $0.82 per basic and
diluted common share, for the three months ended September 30,
2022, compared to a net loss of $2.2 million, or $1.37 per basic
and diluted common share, for the three months ended September 30,
2021.
As of September 30, 2022, the Company had approximately $19.5
million in cash and investments, compared to $25.6 million as of
December 31, 2021.
About ART27.13ART27.13 is a highly potent,
peripherally restricted synthetic, dual G-Protein Coupled 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)
About ART26.12Fatty Acid Binding Proteins
(FABPs) are a family of intracellular proteins that chaperone
lipids including endocannabinoids and fatty acids. Various
inhibitors of FABPs may be particularly useful for the treatment of
specific cancers, neuropathic and nociceptive pain, and anxiety
disorders. ART26.12, Artelo’s lead FABP inhibitor compound, is a
selective inhibitor of FABP5. While developing our lead molecule
for Chemotherapy-Induced Peripheral Neuropathy, additional
compounds from our extensive library of potent and selective
inhibitors of FABPs. have been identified for advancement towards
regulatory-enabling studies in anxiety, cancer and other areas of
high-unmet need where inhibition of FABPs show significant
promise.
About Artelo BiosciencesArtelo Biosciences,
Inc. is a clinical-stage pharmaceutical company focused on
modulating lipid-signaling pathways to develop treatments for
people living with cancer, pain, and neurological conditions.
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
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 the Company’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 the Company’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.
The Company 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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