Artelo Biosciences Provides Business Update and Reports First Quarter 2025 Financial Results

Rhea-AI Summary

Artelo Biosciences (NASDAQ: ARTL) reported its Q1 2025 financial results and provided updates on its clinical pipeline. The company highlighted progress across three key programs: ART26.12, the first selective FABP5 inhibitor in clinical trials, completed Phase I enrollment with data expected in Q2 2025; ART27.13's Phase 2 CAReS study in cancer anorexia-cachexia syndrome with initial data expected in Q3 2025; and ART12.11, a proprietary cannabidiol cocrystal tablet showing improved pharmacokinetics versus Epidiolex®.

Financial results showed R&D expenses of $1.4M (vs $1.5M in Q1 2024), G&A expenses of $1.0M (vs $1.1M), and a net loss of $2.4M ($0.72 per share). Cash position stood at $0.7M, with an additional $0.9M raised through convertible notes in May 2025.

Positive

• ART26.12 completed Phase I enrollment with data expected in Q2 2025
• New potential application for ART26.12 discovered in psoriasis
• ART12.11 demonstrated superior pharmacokinetics compared to Epidiolex®
• Slight reduction in operating expenses compared to Q1 2024
• Secured additional $0.9M funding through convertible notes

Negative

• Low cash position of only $0.7M as of March 31, 2025
• Net loss of $2.4M in Q1 2025
• Additional financing needed to sustain operations beyond current funding

Insights

Biotechnology Analyst

Artelo advances three clinical candidates with near-term catalysts, but faces critical cash constraints requiring immediate financing.

Artelo Biosciences is approaching several potential inflection points across its diversified pipeline targeting lipid-signaling pathways. The company has three key programs advancing with important data readouts expected in 2025:

Their lead candidate ART26.12, the first-in-class FABP5 inhibitor, has completed Phase 1 enrollment with data expected in Q2 2025 (within weeks). Recent peer-reviewed research has expanded its potential beyond oncology into psoriasis, significantly broadening its commercial opportunity in dermatology.

For ART27.13, the company expects initial Phase 2 data for cancer anorexia-cachexia syndrome in Q3 2025. This addresses a significant unmet need in supportive cancer care where few effective treatments exist.

Their ART12.11 program demonstrated superior pharmacokinetics compared to Epidiolex® in canine studies, with human clinical trials for this proprietary CBD cocrystal tablet planned for H2 2025.

However, Artelo's financial position raises serious concerns. With just $0.7 million cash on hand as of March 31 and a quarterly burn rate of approximately $2.4 million ($1.4 million R&D, $1.0 million G&A), the company has insufficient runway. While they secured $0.9 million through convertible notes in early May, this only provides minimal operational funding.

The company explicitly states additional financing will be required soon, creating significant near-term dilution risk for shareholders. This precarious cash position may force Artelo to secure financing under suboptimal terms despite approaching multiple clinical catalysts that could potentially drive valuation.

Quarter-over-quarter, Artelo slightly reduced expenses with R&D at $1.4 million (vs $1.5 million in Q1 2024) and G&A at $1.0 million (vs $1.1 million), demonstrating some financial discipline. Net loss improved marginally to $2.4 million ($0.72 per share) from $2.5 million ($0.78 per share) year-over-year.

Several Key Clinical Readouts in Addition to New Study Initiations Expected in 2025

SOLANA BEACH, Caif., May 13, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, today provided a business update and announced its financial and operational results for the three months ended March 31, 2025.

Business Highlights:

• ART26.12:
  • The first selective fatty acid binding protein 5 (FABP5) inhibitor to enter clinical trials completed enrollment of its Phase I safety study in healthy volunteers. Data readout remains on track for the second quarter of 2025.
  • Newly published peer-reviewed data revealed ART26.12’s potential in psoriasis, expanding its potential therapeutic applications beyond oncology and pain associated with cancer treatments.
• ART27.13:
  • Initial data from its Phase 2 CAReS study in cancer anorexia-cachexia syndrome, expected during the third quarter of 2025.
• ART12.11
  • Reported new data showing that ART12.11, the Company’s proprietary cannabidiol cocrystal tablet, achieved improved pharmacokinetics compared to Epidiolex^® in a head-to-head comparison study in canines.
  • Preparations are underway to initiate human clinical studies with an oral solid dosage form planned for the second half of 2025.

“All of our lead programs are expected to achieve important milestones over the next 12 months,” said Gregory D. Gorgas, President and CEO of Artelo Biosciences. “With additional published preclinical studies demonstrating the utility of FABP5 in oncology and dermatology, we are eager to share the results of our Phase 1 safety trial of ART26.12 in the next few weeks. ART26.12 represents the first product candidate to enter the clinic from our extensive library of selective FABP inhibitors, each with potential tailored use across multiple therapeutic areas, including cancer and inflammatory diseases.”

“During the third quarter of this year, we also look forward to initial results from our Phase 2 CAReS study evaluating ART27.13 in the treatment of cancer-related anorexia and cachexia. This series of near-term milestones highlights the accelerating momentum across our innovative pipeline as well as the remarkable productivity of our scientific leadership and disciplined execution,” Mr. Gorgas concluded.

Q1 2025 Financial Results (Unaudited)

• R&D Expenses: Research and development expenses were $1.4 million for the quarter ended March 31, 2025, compared to $1.5 million for the same period in 2024.
• G&A Expenses: General and administrative expenses were $1.0 million for the quarter ended March 31, 2025, compared to $1.1 million in 2024.
• Net Loss: For the quarter ended March 31, 2025, net loss was $2.4 million, or $0.72 per basic and diluted common share, which included $0.2 million of non-cash expenses, compared to a net loss of $2.5 million, or $0.78 per basic and diluted common share for the quarter ended March 31, 2024, which included $0.1 million of non-cash expenses.
• Cash and Investments: Cash and investments totaled $0.7 million as of March 31, 2025.
• In early May 2025, the Company issued $0.9 million at-market convertible notes. This funding is expected to be sufficient to fund Company operations until additional financing is completed.
  

About ART26.12
ART26.12, Artelo’s lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, is being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic. Cleared by the FDA for a first-in-human study in the US, a Phase 1 trial with ART26.12 was initiated in late 2024. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). 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.

About ART27.13
ART27.13 is a novel benzimidazole derivative being developed as a once-daily, orally administered agent selectively targeting peripheral CB₁ and CB₂ receptors, with the potential to improve body weight, appetite, muscle degeneration, and quality of life in cancer patients. Initially developed by AstraZeneca plc, ART27.13 has been in six clinical studies with over 250 participants. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Having completed a Phase 1 study in cancer patients where ART27.13 demonstrated an excellent safety profile, Artelo is now advancing it in the Phase 2 CAReS trial as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome.

About CAReS
The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in patients with cancer anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to chemotherapy. Now completed, the Phase 1 portion of the CAReS study was designed to determine the most effective and safest dose of ART27.13 for dosing in the Phase 2 stage. Currently enrolling, the Phase 2 portion of the CAReS study is designed to determine estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia. (ISRCTN registry: https://www.isrctn.com/ISRCTN15607817)

About ART12.11
ART12.11 is Artelo’s wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Greatly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. issued composition of matter patent for ART12.11 is enforceable until December 10, 2038.

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. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, 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 are the key clinical milestones expected for Artelo Biosciences (ARTL) in 2025?

Artelo expects ART26.12 Phase I safety data in Q2 2025, ART27.13 Phase 2 CAReS study initial data in Q3 2025, and plans to initiate human clinical studies for ART12.11 in H2 2025.

What was Artelo Biosciences' (ARTL) financial position in Q1 2025?

Artelo reported $0.7M in cash, a net loss of $2.4M ($0.72 per share), R&D expenses of $1.4M, and G&A expenses of $1.0M. The company raised an additional $0.9M through convertible notes in May 2025.

What is ART26.12 and what are its potential applications?

ART26.12 is the first selective FABP5 inhibitor to enter clinical trials, with potential applications in oncology, pain associated with cancer treatments, and newly discovered potential in psoriasis.

How did Artelo's (ARTL) ART12.11 perform compared to Epidiolex?

ART12.11, Artelo's proprietary cannabidiol cocrystal tablet, demonstrated improved pharmacokinetics compared to Epidiolex® in a head-to-head comparison study in canines.

What is the status of Artelo's (ARTL) Phase 2 CAReS study?

The Phase 2 CAReS study evaluating ART27.13 for cancer anorexia-cachexia syndrome is ongoing, with initial data expected during the third quarter of 2025.