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 June 30, 2023 and provided a business update.
“During the second quarter we were pleased to announce the
achievement of multiple objectives and present new data,” said
Gregory D. Gorgas, President and Chief Executive Officer of Artelo
Biosciences. “Notably, based on the very encouraging safety profile
from our Phase 1b study, we initiated Phase 2a of our Cancer
Appetite Recovery Study (CAReS) trial evaluating ART27.13 for the
treatment of cancer-related anorexia and weight loss. We are now
actively enrolling patients and opening new clinical sites to
support the randomized Phase 2a stage of the study.”
In addition, Artelo presented important preclinical data from
multiple animal studies related to ART12.11, a patented cocrystal
composition of cannabidiol (CBD), and ART26.12, a novel Fatty Acid
Binding Protein 5 inhibitor, at the 33rd International Cannabinoid
Research Society Symposium in June. ART12.11 demonstrated improved
bioavailability and superior efficacy in animal models of
stress-induced anxiety versus CBD. Preclinical research in
Chemotherapy-Induced Peripheral Neuropathy (CIPN) showed that
ART26.12 is capable of preventing allodynia from both taxane- and
platinum-based agents, the two most common causes of CIPN.
ART26.12 continues to deliver strong preclinical animal data
supporting its broad potential as an orally administered innovative
treatment for painful neuropathies, including reducing mechanical
hypersensitivity in painful diabetic neuropathy. As a result of a
recent pre-IND meeting with the FDA and ongoing, positive results
with ART26.12 in five studies with three causes of neuropathy,
Artelo anticipates receiving approval to move ART26.12 into the
clinic in the first half of 2024.
“With approximately $14.0 million in cash and investments as of
June 30, 2023, we believe we have the financial resources to
support operations into the second half of 2024. With our current
cash runway, we expect to reach important development milestones
for each of our proprietary programs, specifically: the complete
enrollment of CAReS with ART27.13, the initiation of human trials
with ART26.12, and the disclosure of more results from preclinical
studies with ART12.11,” Mr. Gorgas concluded.
Financial Results Ended June
30, 2023
Operating expenses for the three months ended June 30, 2023,
were $1.8 million compared to $2.5 million for the same period in
2022. The decrease in operating expenses for the three months ended
June 30, 2023, was primarily related to a decrease in general and
administrative expenses associated with a decrease in the
year-over-year service cost of stock-based compensation, a non-cash
expense, along with a decrease in research and development expenses
driven by an increase in tax credits received from the United
Kingdom government, compared to the same period in the prior year,
offset by an increase in research and development expense as a
result of increased salaries to internal research and development
staff along with increased payments to third-party service
providers.
Net loss was approximately $1.6 million, or $0.56 per basic and
diluted share, for the three months ended June 30, 2023, compared
to a net loss of $2.4 million, or $0.87 per basic and diluted
share, for the three months ended June 30, 2022.
As of June 30, 2023, the Company had approximately $14.0 million
in cash and investments, compared to $17.5 million as of December
31, 2022.
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 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. Cancer-related anorexia, or the
lack or loss of appetite in the person with cancer, may result from
the cancer and/or its treatment with radiation or chemotherapy. It
is common for people 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.
Now completed, the Phase 1b portion of the CAReS study was designed
to determine the most effective and safest dose of ART27.13 for
dosing in the Phase 2a stage. Currently enrolling, 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 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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