Artelo Biosciences Affirms Strong Partnering Outlook for ART27.13 Following Positive Interim Phase 2 CAReS Results
Artelo Biosciences (Nasdaq: ARTL) has announced positive interim Phase 2 CAReS trial results for ART27.13, their treatment candidate for cancer anorexia-cachexia syndrome (CACS). The trial demonstrated significant improvements in weight, lean body mass, and activity in treated patients.
CACS affects up to 80% of cancer patients and currently has no FDA-approved treatment. Following these promising results and strong interest from multiple pharmaceutical companies, Artelo is actively pursuing partnership opportunities for ART27.13's development, stating they won't need to internally fund Phase 3 trials.
The company believes a licensing transaction represents the most value-accretive path forward for shareholders in this multi-billion-dollar potential market.
Artelo Biosciences (Nasdaq: ARTL) ha comunicato risultati positivi intermedi della fase 2 dello studio CAReS per ART27.13, il suo candidato terapeutico per la sindrome anoressia-cachettica da cancro (CACS). Lo studio ha mostrato miglioramenti significativi nel peso, nella massa corporea magra e nell'attività dei pazienti trattati.
La CACS interessa fino al 80% dei pazienti oncologici e ad oggi non esistono terapie approvate dalla FDA. A seguito di questi risultati promettenti e dell'interesse manifestato da diverse società farmaceutiche, Artelo sta cercando attivamente partner per lo sviluppo di ART27.13, affermando che non sarà necessario finanziare internamente una fase 3.
L'azienda ritiene che una licenza rappresenti il percorso più vantaggioso per gli azionisti in un mercato potenziale da miliardi di dollari.
Artelo Biosciences (Nasdaq: ARTL) ha anunciado resultados interinos positivos de la fase 2 del ensayo CAReS para ART27.13, su candidato terapéutico para el síndrome de anorexia-cachexia por cáncer (CACS). El estudio mostró mejoras significativas en peso, masa corporal magra y actividad en los pacientes tratados.
El CACS afecta hasta al 80% de los pacientes con cáncer y actualmente no existe tratamiento aprobado por la FDA. Tras estos prometedores resultados y el fuerte interés de varias compañías farmacéuticas, Artelo busca activamente socios para el desarrollo de ART27.13, indicando que no necesitará financiar internamente una fase 3.
La compañía considera que una operación de licencia es la vía que más valor aportaría a los accionistas en un mercado potencial de miles de millones de dólares.
Artelo Biosciences (Nasdaq: ARTL)는 암 관련 식욕부진-카케시아 증후군(CACS) 치료 후보인 ART27.13에 대한 2상 CAReS 시험의 중간 긍정적 결과를 발표했습니다. 해당 임상에서 치료군 환자들의 체중, 제지방량 및 활동성이 유의미하게 개선되었습니다.
CACS는 암 환자의 최대 80%에 영향을 미치며 현재 FDA 승인 치료제가 없습니다. 이러한 유망한 결과와 다수 제약사들의 강한 관심을 바탕으로 Artelo는 ART27.13의 개발을 위한 파트너십을 적극 모색 중이며, 3상 시험을 내부 자금으로 충당할 필요가 없다고 밝혔습니다.
회사는 수십억 달러 규모의 잠재 시장에서 라이선스 계약이 주주 가치를 가장 크게 높이는 방안이라고 판단하고 있습니다.
Artelo Biosciences (Nasdaq: ARTL) a annoncé des résultats intermédiaires positifs de l'étude de phase 2 CAReS concernant ART27.13, son candidat thérapeutique pour le syndrome anorexie-cachexie lié au cancer (CACS). L'essai a montré des améliorations significatives du poids, de la masse maigre et de l'activité chez les patients traités.
Le CACS touche jusqu'à 80 % des patients atteints de cancer et il n'existe actuellement aucun traitement approuvé par la FDA. À la suite de ces résultats prometteurs et de l'intérêt marqué de plusieurs sociétés pharmaceutiques, Artelo recherche activement des partenariats pour le développement d'ART27.13, précisant qu'il ne sera pas nécessaire de financer en interne un essai de phase 3.
L'entreprise estime qu'une transaction de licence représente la voie la plus créatrice de valeur pour les actionnaires sur ce marché potentiel de plusieurs milliards de dollars.
Artelo Biosciences (Nasdaq: ARTL) hat positive Zwischenresultate der Phase-2-CAReS-Studie für ART27.13 bekanntgegeben, ihren Wirkstoffkandidaten gegen das Krebs-Anorexie-Cachexie-Syndrom (CACS). Die Studie zeigte signifikante Verbesserungen bei Gewicht, fettfreier Körpermasse und Aktivität der behandelten Patienten.
CACS betrifft bis zu 80 % der Krebspatienten und es gibt derzeit keine von der FDA zugelassene Therapie. Aufgrund dieser vielversprechenden Ergebnisse und des großen Interesses mehrerer Pharmafirmen sucht Artelo aktiv Partnerschaften für die Weiterentwicklung von ART27.13 und gibt an, eine Phase-3-Finanzierung nicht intern stemmen zu müssen.
Das Unternehmen ist der Ansicht, dass eine Lizenzvereinbarung den wertschaffendsten Weg für Aktionäre in diesem potenziellen Markt im Milliardenbereich darstellt.
- Positive interim Phase 2 results showing improvements in weight, lean body mass, and activity
- Strong interest from multiple pharmaceutical companies for partnership
- No need for internal funding of Phase 3 trials due to partnership potential
- Targeting an unmet medical need affecting 80% of cancer patients
- Multi-billion-dollar market potential with no current FDA-approved treatments
- Phase 3 trials still required for FDA approval
- Success of partnership negotiations not guaranteed
Insights
Artelo reports positive Phase 2 data for CACS treatment, actively pursuing partnership deals rather than self-funding Phase 3 trials.
Artelo Biosciences has released positive interim Phase 2 results for ART27.13 in treating cancer anorexia-cachexia syndrome (CACS), showing improvements in weight, lean body mass, and patient activity levels. This represents a significant milestone in addressing a condition that affects up to
The company's strategic pivot toward securing a development partner rather than internally funding Phase 3 trials makes financial sense given Artelo's size. Management confirms they've received strong interest from multiple pharmaceutical companies that had been awaiting these clinical results.
CACS represents a substantial market opportunity, characterized by the company as a multi-billion-dollar potential market. The condition is particularly serious as it's a leading cause of death among cancer patients, creating urgency for effective therapies.
The partnership strategy aligns with common practice among smaller biotechs that typically lack resources to conduct expensive late-stage trials. By leveraging a larger partner's resources, Artelo can potentially accelerate ART27.13's path to market while preserving capital. This approach effectively transfers late-stage development risk while potentially securing upfront payments, milestone revenues, and eventual royalties should the drug reach commercialization.
SOLANA BEACH, Calif., Sept. 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, affirms that, based on the strength of the positive interim results from its Phase 2 CAReS trial of ART27.13 for cancer anorexia-cachexia syndrome (CACS) and the strong interest expressed by multiple pharmaceutical companies awaiting these results, it is well positioned to secure a development partner for ART27.13. CACS, a leading cause of death in cancer patients and affecting up to
This morning, Artelo announced positive interim Phase 2 results demonstrating compelling improvements in weight, lean body mass, and activity in patients treated with ART27.13. That full release is available here: Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results.
As a result of ongoing discussions with potential partners and the supportive clinical profile of ART27.13 for CACS, Artelo does not envision the need to internally fund a Phase 3 trial and believes a licensing transaction represents the most value-accretive path forward for shareholders.
“This morning’s interim results highlight the potential of ART27.13 to become an FDA and internationally approved therapy for cancer anorexia-cachexia syndrome, an underserved, multi-billion-dollar potential market,” said Gregory D. Gorgas, President and CEO of Artelo. “Based on strong interest from multiple pharmaceutical companies, and given the strength of our newly released data, our immediate strategy is to secure a development partner to efficiently advance ART27.13 through registrational trials. We plan to provide further updates as soon as practical.”
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 seven clinical studies with over 280 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 conducting a Phase 2 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
(ISRCTN registry: https://www.isrctn.com/ISRCTN15607817)
About CACS
Cancer Anorexia-Cachexia Syndrome (CACS) is a condition marked by loss of appetite, weight loss, and the breakdown of muscle and fat, affecting up to
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 its digital asset treasury strategy. 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, including future plans in respect to ART27.13, potential transactions with pharmaceutical companies or other strategic counterparties in respect of ART27.13, 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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