ADDED
The registrant had 2,124,772 shares of Common Stock issued and outstanding as of February 20, 2026.
Some of the statements in the sections captioned Risk Factors , Management s Discussion and Analysis of Financial Condition and Results of Operations , Business , and elsewhere contain forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.
In this Annual Report on Form 10-K, unless otherwise specified, all dollar amounts are expressed in United States dollars ( USD ) and all references to common shares refer to shares of our Common Stock.
This synthetic small molecule program is a G protein-coupled receptor ( GPCR ) designated ART27.13 and was initially developed by AstraZeneca plc.
In an interim analysis of the on-going Phase 2a CAReS trial, patients with cancer anorexia receiving ART27.13 demonstrated a mean weight gain of over 6% compared to a 5% loss in the placebo group, while maintaining a safety profile similar to the Phase 1b despite doses up to twice the previous maximum.
Currently there is no FDA approved treatment for cancer anorexia cachexia syndrome.
Food Drug Administration (the FDA ) clearance for our Investigational New Drug ( IND ) application for ART26.12 in July 2024 and have completed enrolment to a Phase 1 clinical trial in healthy subjects to support the development towards an agent intended to treat chemotherapy-induced peripheral neuropathy ( CIPN ).
In June 2025, we announced favorable results from our first-in-human study evaluating ART26.12.
The Phase 1 Single Ascending Dose (SAD) study was designed to assess the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers and enrolled 49 subjects.
REMOVED
The Registrant had 3,281,032 shares of common stock issued and outstanding as of February 27, 2025.
Some of the statements in the sections captioned Risk Factors, Management s Discussion and Analysis of Financial Condition and Results of Operations, Business, and elsewhere contain forward-looking statements.
Unless otherwise noted, all amounts are expressed in United States dollars ( USD ) and we , us , our and the Company refer to Artelo Biosciences, Inc., including its subsidiaries unless otherwise indicated.
In this Annual Report on Form 10-K, unless otherwise specified, all dollar amounts are expressed in USD and all references to Common Shares refer to shares of our common stock.
This synthetic small molecule program is a G protein-coupled receptor ( GPCR ) designated ART27.13.
Food Drug Administration (the FDA ) clearance for our Investigational New Drug ( IND ) application for ART26.12 in July 2024 and has initiated a Phase 1 clinical trial for chemotherapy-induced peripheral neuropathy.
We are also developing our own invention ART12.11 (the CBD cocrystal ).ART12.11 is our patented solid-state composition of cannabidiol ( CBD ) and tetramethylpyrazine ( TMP ).
ART12.11 may be considered by the regulatory authorities as a fixed drug combination instead of a new chemical entity ( NCE ).
We obtained two of our patent protected product candidates through our in-licensing activities.
ART27.13 is a peripherally-selective high-potency dual CB 1 and CB 2 full-receptor agonist, which was originally invented at AstraZeneca plc ( AstraZeneca ).