Artelo Biosciences Provides Business Update and Reports Second Quarter 2025 Financial Results
Artelo Biosciences (Nasdaq: ARTL) reported Q2 2025 financial results and provided updates on its clinical pipeline. The company highlighted successful completion of Phase 1 Single Ascending Dose study for ART26.12 with positive safety results and is preparing for Multiple Ascending Dose study in Q4 2025.
Key financial metrics include Q2 net loss of $3.2 million ($5.61 per share), R&D expenses of $1.9 million, and cash position of $2.1 million. The company secured additional funding through convertible notes ($0.9M) and two PIPE transactions totaling $10.9 million.
Artelo expects multiple clinical data readouts in Q3 2025, including Phase 2 results from the CAReS study of ART27.13 for cancer anorexia-cachexia syndrome. The company also presented promising preclinical data for ART12.11 in depression treatment and plans first-in-human studies in early 2026.
Artelo Biosciences (Nasdaq: ARTL) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti sul suo pipeline clinico. La società ha evidenziato il completamento con successo della Fase 1 - studio Single Ascending Dose per ART26.12 con riscontri positivi sulla sicurezza e si sta preparando per lo studio Multiple Ascending Dose nel Q4 2025.
I principali indicatori finanziari includono una perdita netta nel Q2 di $3.2 milioni ($5,61 per azione), spese in R&S per $1.9 milioni e una posizione di cassa di $2.1 milioni. L'azienda ha assicurato finanziamenti aggiuntivi tramite obbligazioni convertibili ($0.9M) e due operazioni PIPE per un totale di $10.9 milioni.
Artelo prevede più letture di dati clinici nel Q3 2025, inclusi i risultati di Fase 2 dello studio CAReS su ART27.13 per la sindrome da anoressia-cachessia nei pazienti oncologici. La società ha inoltre presentato dati preclinici promettenti per ART12.11 nel trattamento della depressione e pianifica studi first-in-human all'inizio del 2026.
Artelo Biosciences (Nasdaq: ARTL) informó los resultados financieros del 2T 2025 y dio actualizaciones sobre su cartera clínica. La compañía destacó la finalización con éxito del estudio de Fase 1 de dosis única ascendente para ART26.12 con resultados favorables de seguridad y se está preparando para el estudio de dosis múltiples ascendentes en el 4T 2025.
Los principales indicadores financieros incluyen una pérdida neta en el 2T de $3.2 millones ($5.61 por acción), gastos en I+D de $1.9 millones y efectivo por $2.1 millones. La empresa aseguró financiación adicional mediante pagarés convertibles ($0.9M) y dos transacciones PIPE por un total de $10.9 millones.
Artelo espera múltiples lecturas de datos clínicos en el 3T 2025, incluidos los resultados de Fase 2 del estudio CAReS de ART27.13 para el síndrome de anorexia-caquexia asociado al cáncer. También presentó datos preclínicos prometedores para ART12.11 en el tratamiento de la depresión y planea estudios first-in-human a principios de 2026.
Artelo Biosciences (Nasdaq: ARTL)는 2025년 2분기 재무실적을 발표하고 임상 파이프라인 업데이트를 제공했습니다. 회사는 ART26.12에 대한 제1상 단회 증량(Single Ascending Dose) 연구를 성공적으로 마쳤으며 안전성 결과가 긍정적이라 2025년 4분기에 다회 증량(Multiple Ascending Dose) 연구를 준비 중이라고 밝혔습니다.
주요 재무 지표로는 2분기 순손실 $3.2M (주당 $5.61), 연구개발비 $1.9M, 현금 잔액 $2.1M이 보고되었습니다. 회사는 전환사채($0.9M)와 총 $10.9M 규모의 두 건의 PIPE 거래를 통해 추가 자금을 확보했습니다.
Artelo는 2025년 3분기에 여러 임상 데이터 발표를 예상하며, 여기에는 암 관련 식욕부진-카헥시아 증후군을 대상으로 한 ART27.13의 CAReS 연구 제2상 결과가 포함됩니다. 또한 우울증 치료용 ART12.11의 전임상 데이터가 유망하게 발표되었고, 2026년 초에 최초 인체시험(first-in-human)을 계획하고 있습니다.
Artelo Biosciences (Nasdaq: ARTL) a publié ses résultats financiers du T2 2025 et a communiqué des mises à jour sur son pipeline clinique. La société a souligné l'achèvement réussi de l'étude de Phase 1 à dose unique ascendante pour ART26.12 avec des résultats de sécurité positifs et se prépare à une étude à doses multiples ascendantes au T4 2025.
Les indicateurs financiers clés comprennent une perte nette au T2 de 3,2 M$ (5,61 $ par action), des dépenses R&D de 1,9 M$ et une trésorerie de 2,1 M$. La société a obtenu des financements supplémentaires via des billets convertibles (0,9 M$) et deux transactions PIPE totalisant 10,9 M$.
Artelo attend plusieurs restitutions de données cliniques au T3 2025, y compris les résultats de Phase 2 de l'étude CAReS sur ART27.13 pour le syndrome anorexie‑câchéxie lié au cancer. La société a également présenté des données précliniques prometteuses pour ART12.11 dans le traitement de la dépression et prévoit des études first‑in‑human début 2026.
Artelo Biosciences (Nasdaq: ARTL) veröffentlichte die Finanzergebnisse für Q2 2025 und gab Updates zu seiner klinischen Pipeline. Das Unternehmen hob den erfolgreichen Abschluss der Phase‑1‑Single Ascending Dose‑Studie für ART26.12 mit positiven Sicherheitsbefunden hervor und bereitet eine Multiple Ascending Dose‑Studie für Q4 2025 vor.
Wesentliche Finanzkennzahlen sind ein Nettoverlust im Q2 von $3.2 Mio. ($5,61 je Aktie), F&E‑Aufwendungen von $1.9 Mio. und ein Kassenbestand von $2.1 Mio. Zusätzlich wurden Mittel durch wandelbare Schuldverschreibungen ($0.9M) und zwei PIPE‑Transaktionen in Höhe von insgesamt $10.9 Mio. beschafft.
Artelo erwartet mehrere klinische Daten‑Readouts im Q3 2025, darunter Phase‑2‑Ergebnisse der CAReS‑Studie zu ART27.13 beim krebsbedingten Anorexie‑Kachexie‑Syndrom. Das Unternehmen präsentierte zudem vielversprechende präklinische Daten zu ART12.11 zur Depressionsbehandlung und plant First‑in‑Human‑Studien Anfang 2026.
- Successful completion of Phase 1 SAD study for ART26.12 with positive safety profile
- Secured $10.9 million in new funding through PIPE transactions
- Multiple clinical data readouts expected in Q3 2025
- Expanding therapeutic applications across pain, cancer, and mental health conditions
- Increased net loss to $3.2 million in Q2 2025 from $2.4 million in Q2 2024
- Higher operating expenses with R&D up to $1.9M and G&A up to $1.3M
- Low cash position of $2.1M as of June 30, 2025 necessitated additional funding
- Adoption of Digital Asset Treasury strategy with Solana (SOL) introduces cryptocurrency risk
Insights
Artelo shows strong clinical progress across three assets despite widening losses, with critical data readouts expected in Q3 2025.
Artelo Biosciences' Q2 update reveals encouraging momentum across its pipeline of novel lipid-signaling modulators, with significant clinical milestones approaching. The company has successfully completed a Phase 1 Single Ascending Dose study for ART26.12 (FABP5 inhibitor) with positive safety results and predictable pharmacokinetics, supporting advancement to Multiple Ascending Dose studies in Q4. New preclinical data also validates ART26.12's potential in osteoarthritis, showing significant improvement in weight-bearing function in animal models.
Most critically, Artelo is on track to report Phase 2 data for ART27.13 (cannabinoid receptor agonist) in cancer anorexia-cachexia syndrome this quarter (Q3 2025). This represents a potential significant catalyst, as there are currently no FDA-approved therapies for this condition, creating substantial market opportunity if successful.
The company's third asset, ART12.11 (CBD:TMP cocrystal), is progressing through preclinical development with data showing dual efficacy in depression and cognitive function, targeting the multi-billion-dollar antidepressant market.
Financially, Artelo reported a net loss of
Artelo's FABP5 inhibitor program (ART26.12) is showing substantive clinical progression with the completed Single Ascending Dose study demonstrating a favorable safety profile and linear pharmacokinetics across 49 healthy volunteers. The reported wide therapeutic window is particularly significant as it provides flexibility in dosing strategies – crucial for personalized treatment approaches in pain management.
The preclinical osteoarthritis data presented at the British Pain Society Conference represents meaningful validation of mechanism. The sustained functional improvement for up to four weeks after dosing suggests potential for durable therapeutic effect with this novel mechanism of action. FABP inhibition represents a non-opioid, non-NSAID approach to pain management with potentially fewer side effects than current standards of care.
For ART27.13, the impending Phase 2 CAReS study readout will be decisive in determining whether this peripherally-restricted cannabinoid receptor agonist can address the complex pathophysiology of cancer cachexia. The strategy of using a peripherally-acting compound may help avoid the central nervous system effects that have limited other cannabinoid therapies.
The emerging neuropsychiatric applications for both ART26.12 and ART12.11 demonstrate the company's appreciation for the interconnected nature of lipid signaling pathways across multiple conditions. The dual action of ART12.11 on both depressive behaviors and cognitive function is mechanistically intriguing and addresses a significant unmet need, as many current antidepressants can negatively impact cognitive function.
Multiple Announcements of Clinical Data Results Anticipated in Q3 2025
SOLANA BEACH, Calif., Aug. 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 June 30, 2025.
Business Highlights:
ART26.12 –Advancing Toward Multi-dose Phase 1 Safety Study
- Successfully completed a Phase 1 Single Ascending Dose (SAD) study in 49 healthy volunteers. Data confirmed positive safety results, with only mild, transient adverse events, no drug-related issues, and predictable, dose-linear pharmacokinetics. The wide therapeutic window supports dose titration flexibility and advancement to the next clinical stage.
- Preparations are underway for a Multiple Ascending Dose (MAD) study to start in Q4 2025
- Presented new data at the British Pain Society Conference, validating the therapeutic potential of FABP inhibitors in osteoarthritis (OA). In a surgical rat model of OA, both single and repeat oral doses of ART26.12 significantly improved weight-bearing function, with effects sustained up to four weeks.
- Announced publication of a comprehensive review in Neurobiology of Disease, titled “Fatty acid binding proteins and their involvement in anxiety and mood disorders,” underscoring the potential of FABP inhibitors in treating mood and anxiety disorders, expanding ART26.12’s therapeutic relevance beyond pain.
ART27.13 –Phase 2 Readout Anticipated in Q3 2025
- On track to report initial data from the Phase 2 CAReS study of ART27.13, its peripherally acting cannabinoid receptor agonist, in Q3 2025. Following a successful Phase 1 trial demonstrating safety in cancer patients, ART27.13 is positioned to address significant unmet needs in cancer anorexia-cachexia syndrome, a condition currently lacking any FDA-approved therapies.
ART12.11 – Progress Targeting Depression and Anxiety
- At the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, presented compelling preclinical data for ART12.11, a novel Cannabidiol:Tetramethylpyrazine (CBD:TMP) cocrystal, highlighting dual-action efficacy in alleviating depressive-like behaviors and restoring cognitive function in animals. The results support ART12.11’s potential entry into the multi-billion-dollar antidepressant market.
- Received clear guidance from MHRA, the regulatory authority in the UK, on a streamlined pathway to the clinic. First-in-human study anticipated to start in first half 2026.
Gregory D. Gorgas, President and CEO of Artelo Biosciences, commented on the results of the second quarter, “We are very pleased with the momentum across our pipeline, highlighted by the growing body of evidence supporting our first-in-class FABP5 inhibitor, ART26.12. The successful completion of our Phase 1 SAD study demonstrated positive safety and pharmacokinetics, laying the groundwork for our upcoming MAD study.”
“We are also on track to report Phase 2 data from our CAReS study of ART27.13 during the current third quarter and to collect data demonstrating dual-action efficacy of our preclinical candidate ART12.11 in treating depression and cognitive decline to support our plans to initiate human trials early next year. These achievements reflect our commitment to addressing large unmet medical needs through novel science and thoughtful clinical development,” concluded Mr. Gorgas.
Q2 2025 Financial Results (Unaudited)
- R&D Expenses: Research and development expenses were
$1.9 million for the quarter ended June 30, 2025, compared to$1.7 million for the same period in 2024. - G&A Expenses: General and administrative expenses were
$1.3 million for the quarter ended June 30, 2025, compared to$0.8 million in 2024. - Net Loss: For the quarter ended June 30, 2025, net loss was
$3.2 million , or$5.61 per basic and diluted common share, which included$0.2 million of non-cash expenses, compared to a net loss of$2.4 million , or$4.52 per basic and diluted common share for the quarter ended June 30, 2024, which included$0.1 million of non-cash expenses. - Cash and Investments: Cash and investments totaled
$2.1 million as of June 30, 2025. - In May 2025, the Company issued
$0.9 million at-market convertible notes. - On June 26, 2025, the Company completed a private placement for gross proceeds of
$1.42 5 million. - Subsequent to June 30, 2025, the Company completed an at-the-market PIPE (private investment in public equity) for gross proceeds of
$9.47 5 million. - In connection with the two PIPE transactions, the Company has adopted a Digital Asset Treasury strategy whereby it plans to purchase the digital currency known as Solana (“SOL”) complementing the Company’s expectation to hold and maintain at least one year of cash in traditional instruments to fund its biopharmaceutical develop operations.
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
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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Complementing its scientific innovation, Artelo has adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under a newly authorized digital asset treasury strategy. As the first publicly traded pharmaceutical company to designate Solana as a core reserve asset, Artelo intends to leverage Solana’s high-performance, decentralized blockchain to diversify its balance sheet, enhance liquidity management, and position the Company for long-term value creation in parallel with its therapeutic programs. Guided by disciplined risk controls and staged investments approved by the Board of Directors, this Solana-centric strategy is designed to preserve working capital for the continued advancement and commercialization of Artelo’s product candidates while affording shareholders exposure to a next-generation monetary network. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @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
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