Artelo Biosciences Provides Business Update and Reports Fiscal 2024 Year-End Financial Results

Rhea-AI Summary

Artelo Biosciences (NASDAQ: ARTL) has provided its fiscal 2024 year-end results and business update, highlighting multiple upcoming clinical milestones in 2025. The company reported a net loss of $9.8 million ($3.05 per share) for 2024, compared to $9.3 million in 2023.

Key financial metrics include R&D expenses of $6.0 million (up from $5.7M in 2023), G&A expenses of $4.1 million (down from $4.2M), and cash/investments position of $2.3 million as of December 31, 2024.

Three major clinical programs are advancing:

• ART26.12 (FABP5 inhibitor) Phase 1 study completion expected in Q2 2025
• ART27.13 Phase 2 CAReS trial for cancer anorexia with initial data due by Q2 2025
• ART12.11 (CBD-TMP cocrystal) targeting anxiety and depression, set for human trials in 2H 2025

Positive

• Three clinical programs advancing with milestones in 2025
• R&D expenses increased to $6.0M showing continued investment in pipeline
• G&A expenses decreased to $4.1M showing cost control

Negative

• Net loss increased to $9.8M from $9.3M YoY
• Low cash position of $2.3M may require additional financing
• Higher R&D spending contributing to increased losses

Insights

Financial Analyst

Artelo's financial results highlight a concerning cash position of $2.3 million against a net loss of $9.8 million for fiscal 2024. With an implied quarterly cash burn of approximately $2.5 million, the company appears to have less than one quarter of runway remaining. This critical cash constraint comes at a particularly challenging time with multiple clinical readouts expected throughout 2025.

R&D expenses increased to $6.0 million from $5.7 million year-over-year, reflecting continued investment in their clinical programs despite financial limitations. Meanwhile, G&A expenses showed modest improvement, decreasing to $4.1 million from $4.2 million.

The $3.4 million market capitalization versus $2.3 million cash position suggests minimal enterprise value premium, indicating significant market skepticism about the company's clinical assets. This valuation dynamic creates challenging conditions for raising additional capital, which appears necessary for Artelo to reach its stated clinical milestones.

Artelo's financial position creates a critical timing challenge - bridging current operations to potential value-creating clinical readouts. Absent from the announcement was any mention of financing strategies or partnership discussions, which would typically be expected from a company in this financial position with valuable assets approaching key development milestones.

Biotech R&D Expert

Artelo's pipeline development shows strategic focus around lipid-signaling modulation across three clinical programs, each reaching significant milestones in 2025. The advancement of ART26.12 as the first selective FABP5 inhibitor to enter human studies represents a novel mechanism of action with potential applications across multiple therapeutic areas. The rapid enrollment in their Phase 1 study suggests investigator interest in this approach.

The anticipated initial data from the Phase 2 CAReS trial for ART27.13 in cancer anorexia represents the most near-term clinical catalyst. Cancer-related appetite and weight loss remain significant unmet medical needs with few effective interventions. The company references promising safety and efficacy from Phase 1, but the Phase 2 results will be critical in demonstrating therapeutic value.

Their CBD-TMP cocrystal (ART12.11) program targeting anxiety and depression aims to address the limitations of current therapies, specifically slow onset and addiction potential. The development of an oral solid dosage form overcoming traditional CBD bioavailability challenges could differentiate this approach from other CBD-based therapeutics.

While the clinical progress is noteworthy, the compressed timeline for three separate clinical programs raises operational execution risk, particularly considering the company's financial constraints. The success of these programs will depend on efficient clinical development strategies and the ability to demonstrate compelling efficacy signals that could attract partnership interest or financing to fund continued development.

Multiple Clinical Readouts Due in 2025

SOLANA BEACH, Calif., March 03, 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 fiscal year ended December 31, 2024.

Business Highlights:

• ART26.12: Phase I study is on track for completion in Q2 2025.
• ART27.13: Initial data from the Phase 2 CAReS trial anticipated by the end of Q2 2025.
• ART12.11: Substantial progress has been made toward initiation of human studies with an oral solid dosage form in 2H 2025.
  

“Each of our programs is slated to reach important clinical milestones in 2025,” said Gregory D. Gorgas, President and CEO of Artelo Biosciences. “Notably, enrollment in our Phase 1 study of ART26.12, a Fatty Acid Binding Protein (FABP) inhibitor, has progressed rapidly and is expected to conclude in the second quarter of this year. Designed to harness the power of lipid signaling with broad therapeutic potential, ART26.12 is the first selective FABP5 inhibitor from our proprietary FABP platform to enter human studies. Modulation of lipid-signaling remains Artelo’s key strategy to develop innovative medicines to treat significant unmet needs.”

“In Q2 2025, we also look forward to initial data from our Phase 2 CAReS study of ART27.13 in cancer anorexia. The promising safety and efficacy profile of ART27.13 observed in our Phase 1 study reinforced its potential to address debilitating appetite and weight loss in cancer patients. Additionally, ART12.11, our innovative CBD-TMP cocrystal, is well positioned to begin clinical trials this year. Targeting anxiety and depression, ART12.11 offers a much-needed alternative to drugs with addictive properties or with slow onset of activity. All these developments highlight our progress in advancing transformative therapies with operational efficiency,” Mr. Gorgas concluded.

Fiscal 2024 Year-End Financial Results

• R&D Expenses: Research and development expenses were $6.0 million for the year ended December 31, 2024, compared to $5.7 million for the same period in 2023.
• G&A Expenses: General and administrative expenses were $4.1 million for the year ended December 31, 2024, compared to $4.2 million in 2023.
• Net Loss: For the year ended December 31, 2024, net loss was $9.8 million, or $3.05 per basic and diluted common share, which included $0.6 million of non-cash expenses, compared to a net loss of $9.3 million, or $3.14 per basic and diluted common share for the year ended December 31, 2023, which included $0.4 million of non-cash expenses.
• Cash and Investments: Cash and investments totaled $2.3 million as of December 31, 2024.

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 CB₁and 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 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 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 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 for ARTL in 2025?

ARTL has three major milestones in 2025: ART26.12 Phase 1 completion in Q2, ART27.13 Phase 2 initial data in Q2, and ART12.11 human trials initiation in H2 2025.

How much did Artelo Biosciences (ARTL) spend on R&D in fiscal 2024?

ARTL spent $6.0 million on R&D in fiscal 2024, an increase from $5.7 million in 2023.

What was ARTL's net loss per share for fiscal year 2024?

ARTL reported a net loss of $3.05 per basic and diluted common share for fiscal year 2024.

What is the cash position of ARTL as of December 31, 2024?

ARTL reported cash and investments totaling $2.3 million as of December 31, 2024.

What therapeutic areas is ARTL targeting with its pipeline?

ARTL is developing treatments for cancer, pain, dermatologic conditions, neurological conditions, cancer anorexia, anxiety, and depression.