Artelo Biosciences Reports First Quarter 2023 Financial Results and Provides Business Update
11 May 2023 - 10:00PM
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 March 31, 2023 and provided a
business update.
“Given the positive safety profile observed in the patients with
cancer-associated anorexia participating in the Phase 1b portion of
our Cancer Appetite Recovery Study (CAReS) for our drug candidate,
ART27.13, in April we advanced to the Phase 2a stage of the study,”
said Gregory D. Gorgas, President and Chief Executive Officer of
Artelo Biosciences. “New for the Phase 2a, randomized patients will
be monitored for increased physical activity with a validated
wearable device in addition to the other efficacy assessments
utilized in the first stage. We also obtained regulatory approval
to increase the allowable concurrent anti-cancer treatments, as
well as expand the number of Phase 2a participants to 40.”
“With ample financial resources to support our operations into
the second half of 2024, we not only expect to complete enrollment
of CAReS, we also plan to file the application to begin human
trials with ART26.12 and to advance preclinical studies of ART12.11
to support its transition to the clinic,” Mr. Gorgas concluded.
Financial Results Ended March
31, 2023
Operating expenses for the three months ended March 31, 2023,
were $2.3 million compared to $1.9 million for the same period in
2022. The increase in operating expenses for the three months ended
March 31, 2023, was primarily related to an increase in research
and development expense in the prior year as a result of tax
credits received from the United Kingdom government, of which
similar credits have not yet been received in the current year,
offset by a decrease in stock-based compensation expense.
Net loss was approximately $2.2 million, or $0.76 per basic and
diluted share, for the three months ended March 31, 2023, compared
to a net loss of $2.0 million, or $0.70 per basic and diluted
share, for the three months ended March 31, 2022.
As of March 31, 2023, the Company had approximately $15.5
million in cash and investments, compared to $17.5 million as of
December 31, 2022.
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-associated 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. 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 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.
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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