Artelo Biosciences Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Update

Rhea-AI Summary

Artelo Biosciences (ARTL) announced the receipt of Clinical Trials Authorization for its Cancer Appetite Recovery Study (CAReS) of ART27.13 in the UK. This Phase I/II trial targets cancer patients suffering from anorexia, addressing a significant unmet medical need. The company also secured a Mitacs Accelerate grant to further develop its ART26.12 program, exploring its potential in treating anxiety disorders. Financially, ARTL reported a net loss of $1.43 million for Q1 FY2021, with operating expenses slightly rising to $1.44 million.

Positive

• Received Clinical Trials Authorization for Phase I/II study of ART27.13.
• Awarded Mitacs Accelerate grant for ART26.12, expanding research to anxiety disorders.
• Closed $7.6 million public offering, enhancing cash position.

Negative

• Net loss increased to $1.43 million for Q1 FY2021, compared to $1.31 million in the prior year.
• Operating expenses rose to $1.44 million, primarily due to increased professional fees.

Received Clinical Trial Authorization to Commence Cancer Appetite Recovery Phase I/II Clinical Study of ART27.13 in UK

Awarded Mitacs Accelerate Grant

LA JOLLA, Calif., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system, today reported financial and operating results for the first quarter of its fiscal year ended November 30, 2020 and provided a business update.

“During the first quarter of fiscal 2021 we received both the Ethics approval and the Clinical Trials Authorization (CTA) in the United Kingdom for the Cancer Appetite Recovery Study (CAReS) for our lead drug candidate, ART27.13, a high-potency GPCR agonist,” stated Gregory Gorgas, Chief Executive Officer of Artelo Biosciences. “The CTA was the final regulatory approval required for the initiation of our Phase 1/2 trial in cancer patients with anorexia which is a significant unmet need that has no recommended standard of care according to the 2020 Guidelines from the American Society of Clinical Oncology. We expect to announce enrollment within the coming weeks and to report initial safety and efficacy data within six months of study initiation and completion of the full study enrollment within 12 months.”

“We are also pleased to have been awarded, alongside the University of Western Ontario, a Mitacs Accelerate grant for our Fatty Acid Binding Protein 5 (FABP5) inhibitor program, known as ART26.12,” continued Mr. Gorgas. “This grant provides funding to expand our focus with ART26.12 beyond our current program in cancer into central nervous system disorders such as anxiety and further demonstrates the potential broad applicability of targeting FABP5. The Accelerate grant is expected to fund 50% of expenses related to preclinical research investigating ART26.12 as a potential treatment for anxiety disorders, including the potential of enhanced efficacy and reduced cognitive impact compared to current anxiolytics.”

Additional First Quarter Fiscal 2021 Highlights:

• Closed $7.6 million underwritten public offering with full exercise of underwriter’s option.
• Filed a method of use patent with the U.S. Patent and Trademark Officer covering the use of our ART26.12 for the treatment of psychological disorders.
• Presented in two keynote panels at the 3^rd Annual International Cannabinoid Derived Pharmaceutical Summit.
  

First Quarter Fiscal 2021 Financial Results:

• Operating expenses for the three months ended November 30, 2020 were $1,435,212 compared to $1,336,448 for the same period in 2019. The increase in operating expenses was primarily due to an increase in professional fees related to financing related SEC filings.
• Net loss was approximately $1,434,645, or $0.14 per basic and diluted share for the three months ended November 30, 2020 compared to a net loss of $1,306,361, or $0.39 per basic and diluted share for the three months ended November 30, 2019.
• As of November 30, 2020, the Company had approximately $7,388,686 in cash and cash equivalents.
  

About Artelo Biosciences
Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting endogenous signaling pathways, including the endocannabinoid system. Artelo is rapidly 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 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 Statements
This 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, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com

FAQ

What is the purpose of the Cancer Appetite Recovery Study (CAReS) by ARTL?

The CAReS study aims to assess the effectiveness of ART27.13 in cancer patients experiencing anorexia.

When does Artelo Biosciences expect to report initial data from the CAReS study?

Initial safety and efficacy data are expected within six months of the trial's initiation.

What financial results did Artelo Biosciences report for Q1 FY2021?

Artelo reported a net loss of approximately $1.43 million for the first quarter.

How much funding did Artelo receive through the Mitacs Accelerate grant?

The grant will fund 50% of the expenses related to preclinical research for ART26.12.