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

Rhea-AI Summary

Artelo Biosciences has made significant strides in its clinical development, recently commencing patient enrollment in the Phase 1/2 CAReS study of ART27.13, aimed at treating cancer anorexia. The company reported positive pre-clinical results for its CBD cocrystal, ART12.11, showing enhanced efficacy in cancer models. Financially, Artelo holds approximately $11.2 million in cash and cash equivalents as of February 28, 2021, which provides ample runway for upcoming milestones. However, the net loss for the quarter was around $1.87 million, indicating ongoing financial challenges.

Positive

• Commenced patient enrollment in Phase 1/2 study of ART27.13.
• Positive pre-clinical data for ART12.11 demonstrating improved efficacy.
• Approximately $11.2 million in cash and cash equivalents as of February 28, 2021.

Negative

• Net loss of approximately $1.87 million for the quarter ended February 28, 2021.

Recently Commenced Patient Enrollment in Phase 1/2 CAReS Study of ART27.13 in the UK

Reported Positive Pre-Clinical Data Associated with Artelo’s Proprietary CBD Cocrystal

$11.2 Million of Cash and Cash Equivalents and Marketable Securities as of February 28, 2021

LA JOLLA, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that target lipid-signaling pathways, including the endocannabinoid system, today reported financial and operating results for the second quarter of its fiscal year ended February 28, 2021 and provided a business update.

“We are pleased to report continued clinical and corporate progress during the second quarter of 2021,” stated Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “Most recently, we dosed the first patient in our Phase 1/2 Cancer Appetite Recovery Study (CAReS) of ART27.13, marking a major milestone for Artelo. We believe ART27.13 has the potential to become a standard of care treatment for cancer anorexia, a wasting syndrome associated with significant weight loss that affects more than 60% of all cancer patients and is a leading cause of mortality in this population. Our goal is to complete the study within approximately twelve months, and we anticipate announcing meaningful clinical updates as we advance through the trial.”

During the quarter, the Company announced positive pre-clinical data associated with its proprietary CBD cocrystal, ART12.11, showing potential pharmacodynamic interactions of its components, cannabidiol (CBD) and tetramethylpyrazine (TMP), in cell-based models of cancer.  The study observed enhanced effects between CBD and TMP versus either compound alone, reinforcing Artelo’s CBD cocrystal’s potential for improved efficacy and differentiation from other forms of CBD. The full data is expected to be disclosed at a future scientific conference.

“We ended the quarter with approximately $11.2 million of cash and cash equivalents, and marketable securities, which provides us more than sufficient runway to execute on a number of key upcoming milestones that we believe have the potential to drive significant value for shareholders,” added Randy Schreckhise, Vice President Finance and Operations. “At the same time, we continue to expand our senior management and board of directors with key additions, as well as enhance our intellectual property protection with additional patent filings,” continued Mr. Schreckhise. “We believe we have built a robust therapeutic pipeline addressing underserved, multi-billion dollar markets and we remain highly encouraged by the outlook for the business.”

Second Quarter Fiscal 2021 Highlights:

• Announced positive laboratory data associated with proprietary CBD cocrystal demonstrating co-administration of CBD and TMP could confer ART12.11 with a more desirable pharmacodynamic profile.
• Announced non-clinical research collaboration with Trinity College Dublin, Ireland to further investigate ART27.13 for the treatment of cancer cachexia.
• Filed a composition of matter patent application regarding a new solid dosage formulation, including its method of use, with the UK Patent Office for ART27.13.
• Appointed Andrew Yates, Ph.D. as Senior Vice President and Chief Scientific Officer.
• Appointed Tamara A. Seymour, CPA, and Gregory R. Reyes, M.D., Ph.D. to Artelo’s Board of Directors.
  

Second Quarter Fiscal 2021 Financial Results:

• Operating expenses for the three months ended February 28, 2021 were $1,867,509 compared to $1,370,534 for the same period in 2020. The company’s operating expenses were primarily related to professional fees for ongoing regulatory requirements, research and development and general and administrative expenses.
• Net loss was approximately $1,865,921, or $0.11 per basic and diluted share for the quarter ended February 28, 2021 compared to a net loss of $1,370,126, or $0.40 per basic and diluted share for the quarter ended February 29, 2020.
• As of February 28, 2021, the Company has approximately $11,218,461 in cash and cash equivalents and marketable securities.
  

About Artelo Biosciences

Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting lipid 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 current status of ART27.13 clinical trials?

Artelo has commenced patient enrollment in the Phase 1/2 CAReS study for ART27.13.

What positive results were reported for ART12.11?

Positive pre-clinical data showed enhanced pharmacodynamic interactions in cancer models.

What were Artelo's financial results for the second quarter of 2021?

The company reported a net loss of approximately $1.87 million and has $11.2 million in cash and cash equivalents as of February 28, 2021.

What is the focus of Artelo Biosciences?

Artelo focuses on developing therapeutics targeting lipid-signaling pathways, including the endocannabinoid system.

When can we expect updates from the ART27.13 study?

Meaningful clinical updates are anticipated as the company advances through the trial within approximately twelve months.