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SOLANA BEACH, Calif. - Artelo Biosciences, Inc. (NASDAQ:ARTL), a small-cap biotech company with a market capitalization of $12.3 million, announced Monday that its fatty acid binding protein 5 (FABP5) inhibitor ART26.12 demonstrated favorable results in a preliminary food effect evaluation conducted as part of its Phase 1 single ascending dose clinical trial. The stock has shown strong momentum, gaining nearly 40% over the past six months, though InvestingPro analysis indicates the shares are currently trading above their Fair Value.
The study assessed the pharmacokinetics and safety profile of ART26.12 in healthy volunteers under both fed and fasted conditions. Participants received three single doses of the drug separated by 7-day intervals, with no serious adverse events reported. All reported adverse events were mild and self-limiting. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though its current ratio of 0.39 suggests tight liquidity management.
The data showed consistent exposure levels under fasted conditions with low inter-subject variability. According to the company, plasma pharmacokinetics suggest ART26.12 can be effectively administered with or without food.
"The SAD and Food Effect study provides us with the knowledge that we can choose to dose in both the fed or fasted state in future trials," said Andrew Yates, Senior Vice President and Chief Scientific Officer at Artelo.
ART26.12 is described as a selective, orally administered, and peripherally acting FABP5 inhibitor representing a new therapeutic class with a non-opioid, non-steroidal analgesic approach. The company is initially developing it for chemotherapy-induced peripheral neuropathy.
Artelo plans to advance ART26.12 to a multiple ascending dose study, which is expected to begin in the fourth quarter of this year.
The U.S. National Institutes of Health has included ART26.12 in its Helping to End Addiction Long-term initiative’s Preclinical Screening Platform for Pain program, which aims to advance non-opioid solutions to pain.
This article is based on information from a company press release. Analysts maintain a strong buy recommendation on ARTL with a price target of $18, significantly above current trading levels. InvestingPro subscribers have access to 8 additional key insights about Artelo Biosciences, including detailed financial health metrics and growth indicators.
In other recent news, Artelo Biosciences has secured European patent protection for its cancer drug formulation ART27.13, extending its protection through December 2041. The company is currently evaluating ART27.13 in a Phase 2 clinical trial for the treatment of cancer-related anorexia. Additionally, Artelo Biosciences announced a $9.475 million private placement to initiate a Solana-based treasury strategy, making it the first publicly-traded pharmaceutical company to adopt Solana’s cryptocurrency as a core reserve asset. The company has also received favorable guidance from the UK’s Medicines and Healthcare products Regulatory Agency for a Phase 1 trial of its CBD:TMP cocrystal, intended for anxiety and depression treatment. The regulatory body approved a streamlined clinical trial application process for this novel cocrystal. Furthermore, D. Boral Capital has reaffirmed its Buy rating on Artelo Biosciences, with a price target of $20.00, highlighting upcoming catalysts such as the planned launch of a Phase 1 clinical trial for ART12.11 in early 2026.
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