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 3rd 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
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Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com