Artelo Biosciences Announces Publication of New Peer-Reviewed Study Demonstrating Intraperitoneal Administration of a Novel Fatty Acid Binding Protein 5 (FABP5) Inhibitor Significantly Reduces Stress-Induced Anxiety and Depression Behaviors in Preclinical Models

Rhea-AI Summary

Artelo Biosciences (Nasdaq: ARTL) announced a peer‑reviewed publication (Dec 3, 2025) reporting that intraperitoneal dosing of its proprietary FABP5 inhibitor SBFI103 produced robust anxiolytic and antidepressant‑like effects in a validated chronic‑stress rat model.

Key experimental findings include single‑dose reductions in anxiety‑ and depression‑like behaviors with no locomotion or memory deficits, increased hippocampal expression of endocannabinoid‑related receptors CB2, GPR55, TRPV1, prevention of stress‑linked declines in depression biomarkers, and blockade of chronic‑stress effects on hippocampal neurogenesis.

The company funded the research; authors controlled study design and conclusions. Artelo said the data strengthen the rationale to advance FABP5 inhibitors (including ART26.12) toward human studies.

Positive

• Single‑dose SBFI103 produced robust anxiolytic and antidepressant‑like effects in chronically stressed rats
• Peripheral (intraperitoneal) dosing modulated central stress‑regulated pathways
• Increased hippocampal gene expression of CB2, GPR55, and TRPV1 receptors
• Prevention of stress‑induced reductions in depression biomarkers and neurogenesis

Negative

• Findings are preclinical (rodent) results and not clinical efficacy in humans

News Market Reaction

-8.33% 11.9x vol

22 alerts

-8.33% News Effect

+71.5% Peak Tracked

-8.4% Trough Tracked

-$376K Valuation Impact

$4M Market Cap

11.9x Rel. Volume

On the day this news was published, ARTL declined 8.33%, reflecting a notable negative market reaction. Argus tracked a peak move of +71.5% during that session. Argus tracked a trough of -8.4% from its starting point during tracking. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $376K from the company's valuation, bringing the market cap to $4M at that time. Trading volume was exceptionally heavy at 11.9x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Reality Check

Price: $1.71 Vol: Volume 59,467 is at 0.05x...

low vol

$1.71 Last Close

Volume Volume 59,467 is at 0.05x the 20-day average of 1,315,366, indicating muted trading activity ahead of this news. low

Technical Shares at $1.94 are trading below the 200-day MA of $6.60 and 93.22% below the 52-week high of $28.60.

Peers on Argus

Biotech peers with highest affinity scores (e.g., CERO, TNFA, ADIL) mostly showe...

1 Up

Biotech peers with highest affinity scores (e.g., CERO, TNFA, ADIL) mostly showed declines between -1.5% and -10%, while ARTL was up 2.15% over 24 hours, suggesting stock-specific dynamics rather than a sector-wide move.

Historical Context

5 past events · Latest: Dec 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Preclinical study	Positive	-8.3%	Peer-reviewed rat data showing SBFI103 reduces stress-related behaviors via FABP5 inhibition.
Nov 12	Earnings & update	Neutral	-8.2%	Q3 2025 results with pipeline progress alongside continued losses and small-cap financings.
Nov 04	Scientific review	Positive	-38.0%	Peer-reviewed review on FABP3 in cancer supporting therapeutic potential of FABP inhibition.
Oct 27	Management change	Positive	-0.3%	Appointment of an experienced life sciences CFO to support financial and growth plans.
Oct 15	Clinical data	Positive	+1.4%	Expanded clinical data on ART26.12 safety and ART27.13 weight-gain benefits in cancer anorexia.

Pattern Detected

Recent news, including positive scientific and clinical updates, has often been followed by negative price reactions, indicating a pattern of sell-offs into good news.

Recent Company History

Over the last few months, Artelo released several scientifically positive updates, including expanded clinical data on ART26.12 and ART27.13, and peer-reviewed publications on FABP targets, yet shares frequently declined afterward. Corporate developments such as appointing a new CFO and significant financing and regulatory filings underscored liquidity pressure and going‑concern risks. Today’s preclinical FABP5 study publication further builds the scientific case for the FABP5 platform, fitting into a pattern where strong research catalysts appear against a backdrop of financial and listing challenges.

Market Pulse Summary

The stock moved -8.3% in the session following this news. A negative reaction despite positive precl...

Analysis

The stock moved -8.3% in the session following this news. A negative reaction despite positive preclinical results fits a recent pattern where favorable scientific or clinical updates were followed by share price declines. Regulatory filings disclosed substantial doubt about continuing as a going concern, significant recent financings, and Nasdaq delisting risk, all of which can overshadow incremental research progress. Such a decline would have reflected market focus on balance sheet and listing uncertainties rather than the study alone.

Key Terms

intraperitoneal administration, fatty acid binding protein 5, endocannabinoid system, hippocampal neurogenesis, +4 more

8 terms

intraperitoneal administration medical

"demonstrating that intraperitoneal administration of Artelo’s proprietary FABP5 inhibitor"

Intraperitoneal administration is a way of delivering a drug or treatment by placing it directly into the peritoneal cavity, the space that surrounds the abdominal organs. For investors, this matters because the route affects how quickly and where a drug acts, the design and cost of clinical trials, manufacturing and delivery systems, and regulatory review—similar to comparing delivering fertilizer to a plant’s roots versus sprinkling it on the surface.

fatty acid binding protein 5 medical

"Inhibition of fatty acid binding protein 5 prevents stress-induced anxiogenic"

Fatty acid binding protein 5 (FABP5) is a small protein inside cells that helps carry fat molecules where they’re needed, like a courier moving packages within a warehouse. Investors care because changes in FABP5 levels or function can serve as disease markers or drug targets, affecting the value of diagnostics and therapies in development and shaping regulatory and commercial outcomes for health-related companies.

endocannabinoid system medical

"key receptors within the endocannabinoid system, including CB2, GPR55, and TRPV1"

A system of receptors, signaling molecules and enzymes in the body that helps regulate appetite, mood, pain, sleep, immune response and other basic functions — acting like an internal messaging and balance system. It matters to investors because drugs, medical treatments or consumer products that safely target this system can create new markets or change competitive dynamics; research results, clinical progress and regulatory rulings can therefore have a direct impact on a company’s commercial prospects and valuation.

hippocampal neurogenesis medical

"Blocking of the detrimental effects of chronic stress on hippocampal neurogenesis"

The growth of new nerve cells in the hippocampus, a part of the brain involved in memory and mood. It matters to investors because drugs or therapies that boost this process can indicate potential treatments for cognitive and mood disorders, affecting clinical trial results, regulatory approval chances, and commercial value. Think of it like hiring new librarians for a library: more staff can improve how information is organized and retrieved, which can make a treatment more promising.

cannabinoid medical

"endocannabinoid-mediated neurotransmission and, in turn, ameliorate stress-induced"

Cannabinoids are chemical compounds that interact with the body’s cell signaling system that influences mood, appetite, pain and inflammation; they occur naturally in the cannabis plant, are made by the body, or can be created synthetically. Investors watch cannabinoids because they are the active ingredients that determine a product’s medical effects, consumer demand and regulatory treatment—think of them as the “active ingredient” in a drug or the key flavor that drives sales and legal rules.

neurotrophic signaling medical

"neurotrophic signaling in the limbic circuitry"

Neurotrophic signaling is the cellular communication system by which specialized proteins, called neurotrophic factors, send survival, growth and connection instructions to nerve cells; think of them as a fertilizer and instruction manual that keeps neurons healthy and wired correctly. For investors, evidence that a drug or technology modulates these signals can indicate potential to treat neurodegenerative or injury-related conditions, affecting therapeutic value, regulatory risk and market opportunity.

limbic circuitry medical

"neurotrophic signaling in the limbic circuitry"

Limbic circuitry is the network of brain regions that regulate emotions, memory, motivation and responses to reward or stress — think of it as the brain’s emotional control center. It matters to investors because many drugs, devices and diagnostics aim at these circuits to treat psychiatric and neurological conditions; how well a therapy affects limbic circuitry can determine clinical trial outcomes, regulatory approval and the commercial potential of neuro-related products.

neurogenesis medical

"support neurogenesis—two key therapeutic objectives for treating depression"

The growth of new nerve cells in the brain and nervous system, a process that helps repair damage, form memories, and maintain brain function. For investors, neurogenesis matters because drugs or therapies that reliably boost or protect this process can signal potential treatments for conditions like memory loss, depression, or neurodegenerative diseases, which may affect market value, regulatory review, and long-term revenue prospects. Think of it as the brain’s ability to plant and nurture new seedlings that keep a garden healthy.

AI-generated analysis. Not financial advice.

Findings further validate FABP5 inhibition and strengthen the therapeutic potential of Artelo’s FABP5 platform for mood and stress-related disorders

SOLANA BEACH, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today announced the publication of new peer-reviewed research from the laboratory of Dr. Steven Laviolette, Professor in the Schulich School of Medicine at the University of Western Ontario, Canada, partially funded by the Company, demonstrating that intraperitoneal administration of Artelo’s proprietary FABP5 inhibitor SBFI103 produces robust anxiolytic and antidepressant-like effects in a validated preclinical model of chronic stress.

The paper, titled “Inhibition of fatty acid binding protein 5 prevents stress-induced anxiogenic and depressive-like symptoms through modulation of hippocampal neurogenesis, cannabinoid and neurotrophic signaling in the limbic circuitry,” was published in Neurobiology of Disease and builds on the earlier research from the Laviolette laboratory showing that direct delivery of SBFI103 into specific brain regions accelerated fear extinction and reduced anxiety-related behaviors.

Key Findings

The newly published study demonstrates that intraperitoneal administration of SBFI103 leads to significant:

• Reductions in anxiety- and depression-like behaviors in chronically stressed rats after a single dose, with no adverse impact on locomotion or memory
• Increased gene expression of key receptors within the endocannabinoid system, including CB₂, GPR55, and TRPV1, in the hippocampus
• Prevention of stress-induced reductions in biomarkers associated with depression in the hippocampus
• Blocking of the detrimental effects of chronic stress on hippocampal neurogenesis, a critical biological process linked to mood regulation and cognitive function

Lead author, Taygun Uzuneser, Ph.D., commented, “We demonstrated that inhibition of FABP5 by SBFI103 represents a promising strategy to effectively elevate endocannabinoid-mediated neurotransmission and, in turn, ameliorate stress-induced affective and anxiogenic disturbances in rats. Remarkably, FABP5 inhibition powerfully prevented the impacts of chronic stress on adult hippocampal neurogenesis and neurotrophic signaling disturbances, demonstrating a unique neurobiological mechanism by which indirect modulation of the endocannabinoid system can prevent stress-induced pathophysiology.”

This new publication provides compelling evidence that peripheral dosing of SBFI103 can modulate central stress-regulated pathways and support neurogenesis—two key therapeutic objectives for treating depression, anxiety disorders, and stress-related pathology.

“These findings add important validation to the therapeutic potential of our FABP5 inhibitor platform,” said Gregory D. Gorgas, Chief Executive Officer of Artelo. “The demonstration that SBFI103 can reverse stress-induced behavioral and neurobiological impairments significantly strengthens the scientific rationale for advancing new FABP5 inhibitors such as SBFI103 into future human studies, as we have already successfully accomplished with ART26.12, the first selective FABP5 inhibitor to enter clinical studies.”

The authors of the study were solely responsible for the design, conduct, and conclusions of the research. The Company’s role was limited to funding.

About Artelo Biosciences

Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by an experienced executive team collaborating with world-class researchers and technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices, including digital assets, to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio.

About ART26.12

ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is under development as a novel, peripherally acting, non-opioid, non-steroidal analgesic, initially for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) under an investigational new drug application opened with the U.S. FDA. Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders.

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 statements 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 did Artelo announce on December 3, 2025 about SBFI103 (ARTL)?

Artelo announced a peer‑reviewed study showing intraperitoneal SBFI103 reduced anxiety‑ and depression‑like behaviors in chronically stressed rats.

How did SBFI103 affect hippocampal markers in the published study for ARTL?

The study reported increased hippocampal gene expression of CB2, GPR55, and TRPV1 and prevention of stress‑related biomarker declines.

Does the Artelo (ARTL) study show SBFI103 works in humans?

No; the published results are preclinical (rat) data and do not demonstrate human clinical efficacy.

What route of administration was used in the Artelo (ARTL) preclinical study?

The study used intraperitoneal administration of SBFI103 in chronically stressed rats.

Why do Artelo (ARTL) executives say the SBFI103 results matter for future studies?

Company commentary said the data validate FABP5 inhibition and strengthen the rationale to advance FABP5 inhibitors into human studies.