Artelo Biosciences, Inc. (ARTL) experienced a dramatic surge of over 130% in premarket trading Monday, reaching $23 per share following the release of positive preclinical data for its depression treatment candidate ART12.11 and favorable results from its first-in-human study of pain treatment ART26.12.
Depression Treatment Shows Promise Against Stress-Induced Symptoms
The preclinical data for ART12.11 demonstrated significant improvements in depression-related behaviors in animals and successfully reversed cognitive deficits associated with chronic stress. According to the company, ART12.11 showed efficacy comparable to Pfizer's established antidepressant Zoloft in the stress-induced depression model.
Non-Opioid Pain Treatment Advances to Human Testing
Simultaneously, Artelo announced favorable results from its first-in-human study evaluating ART26.12, a non-opioid treatment candidate for persistent pain. The drug is being developed as a novel, peripherally acting, non-steroidal analgesic with initial clinical development planned for chemotherapy-induced peripheral neuropathy (CIPN), a condition characterized by nerve damage caused by certain chemotherapy drugs leading to sensory, motor, or autonomic dysfunction.
Safety Profile and Pharmacokinetics Demonstrate Clinical Viability
The human trial results showed that all adverse events were mild, transient, and self-resolving. The study demonstrated predictable pharmacokinetics for ART26.12, with complete dose-exposure profiles explored and tests confirming dose-dependent, linear absorption across the evaluated range.
Andrew Yates, Chief Scientific Officer at Artelo, expressed satisfaction that "the safety and pharmacokinetic profile generated from ART26.12's non-clinical studies translated well to the human experience."
Market Opportunity and Development Timeline
Artelo highlighted the substantial market opportunity, noting that the chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030. This growth is driven by increasing prevalence of conditions such as neuropathic pain, arthritis, and fibromyalgia.
The company plans to commence a multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing over time in the fourth quarter of this year.
Financial Considerations and Market Response
Despite the positive clinical developments, investors noted potential funding challenges ahead. The company reported cash and investments totaling only $0.7 million as of the end of the first quarter, raising questions about the need for additional capital to advance its pipeline.
ARTL stock has gained approximately 135% year-to-date and about 85% over the past 12 months, with retail sentiment on trading platforms shifting from bearish to extremely bullish following the latest announcements.
