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 three months ended June 30, 2022.
“During this past quarter 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,”
stated Gregory D. Gorgas, President and Chief Executive Officer of
Artelo Biosciences. “Based upon the CAReS safety review committee’s
conclusion that ART27.13 was well-tolerated with no serious adverse
events attributable to the investigational drug, we initiated a
fourth cohort at a 650-microgram dose. With the momentum from an
increasing number of clinical sites, we expect to complete the
Phase 1b stage and to commence enrollment in the Phase 2b stage of
CAReS in the fourth quarter of 2022.”
“Furthermore, we maintained a solid balance sheet with over
$21.3 million in cash and cash equivalents. This capital is
anticipated to support our operations through the end of 2023,
enabling Artelo to deliver on important clinical and preclinical
milestones,” concluded Mr. Gorgas.
Artelo’s Board of Directors approved a 15-for-1 reverse stock
split of the Company’s common stock. The Company’s common shares
will begin trading on a split-adjusted basis on the Nasdaq Capital
Market commencing at the market open, August 10, 2022. The Board of
Directors determined the 15-for-1 ratio to be appropriate in order
to improve the marketability and liquidity of Artelo’s common stock
and to regain compliance with all of Nasdaq’s continued listing
requirements.
As a result of the reverse split, each fifteen shares of the
Company’s issued and outstanding common stock will be automatically
combined and converted into one issued and outstanding share of
common stock. Each shareholder’s pro-rata percentage ownership will
remain unchanged as a result of the reverse split and no further
action is required by shareholders. All of the Company’s current
outstanding warrants to purchase shares of common stock and other
derivatives automatically adjust per their terms to reflect the
reverse split. Immediately after the reverse split becomes
effective, there will be approximately 2.8 million shares of common
stock issued and outstanding. For further details, all shareholders
are invited to review the 8-K regarding this reverse split filed
today, August 9, 2022.
Other Business Highlights
In its review of data from the first three Phase 1b cohorts, the
safety review committee for CAReS affirmed that ART27.13 has been
well-tolerated with no serious adverse events (SAEs) related to
ART27.13 in study patients suffering from anorexia associated with
cancer. In addition, ART27.13’s safety profile appears more benign
among cancer patients participating in CAReS than observed in
healthy volunteers in prior Phase 1 studies with ART27.13 while the
pharmacokinetics remained consistent between the two studies. This
more recent safety profile plus an observed improvement in anorexia
from each dose escalation led to the decision to expand to the
fourth cohort at a 650-microgram dose.
Pre-clinical research of ART26.12, Artelo’s lead FABP5
inhibitor, indicated that chronic, oral treatment was effective at
preventing and treating both oxaliplatin- and paclitaxel-induced
pain sensitivity without any sedating effects in rats. In addition,
prevention studies of ART26.12 minimized acute weight loss caused
by oxaliplatin. 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.
Financial Results Ended June
30, 2022
Operating expenses for the three months ended June 30, 2022,
were $2.4 million compared to $2.3 million for the same period in
2021. The increase in operating expenses for the three months ended
June 30, 2022, was primarily related to increases in payroll and in
subcontractor expenditures relating to the Company’s ART27.13
clinical trial.
Net loss was approximately $2.4 million, or $0.87 per basic and
diluted common share, for the three months ended June 30, 2022,
compared to a net loss of $ 2.3 million, or $1.45 per basic and
diluted common share, for the three months ended June 30, 2021.
As of June 30, 2022, the Company had approximately $21.3 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
compound(s) from our extensive library of potent and selective
inhibitors of FABPs have been identified and selected for
advancement towards regulatory-enabling studies in 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 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
Artelo Biosciences (NASDAQ:ARTL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Artelo Biosciences (NASDAQ:ARTL)
Historical Stock Chart
From Apr 2023 to Apr 2024