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Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)

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Raphael Pharmaceutical (OTCQB: RAPH) filed a provisional patent application (No. 63/911,729) on Nov 17, 2025 for its highly purified, THC‑free/CBD‑free cannabinoid platform targeting neutrophil‑dominant autoimmune diseases, including rheumatoid arthritis (RA).

The filing was joint with Rambam Health Care Campus and follows an IRB‑approved eight‑week U.S. proof‑of‑concept study that reported significant improvements in pain, sleep, well‑being and a DAS28 reduction from high to moderate disease severity, with no adverse effects reported. The company describes RaphaWell as an orally delivered, non‑psychoactive candidate moving toward initial commercial launch.

Raphael Pharmaceutical (OTCQB: RAPH) ha presentato una domanda di brevetto provvisorio (No. 63/911,729) il 17 novembre 2025 per la sua piattaforma di cannabinoidi altamente purificata, senza THC/CBD, mirata a malattie autoimmuni dominanti dai neutrofili, inclusa l'artrite reumatoide (RA).

La domanda è stata presentata congiuntamente al Rambam Health Care Campus e segue uno studio di dimostrazione concetto statunitense di otto settimane approvato dall'IRB che ha riportato miglioramenti significativi nel dolore, nel sonno, nel benessere e una riduzione DAS28 da severa a moderata gravità della malattia, senza effetti avversi riportati. L'azienda descrive RaphaWell come un candidato somministrato per via orale, non psicoattivo, in fase di avvio commerciale.

Raphael Pharmaceutical (OTCQB: RAPH) presentó una solicitud de patente provisional (No. 63/911,729) el 17 de noviembre de 2025 para su plataforma de cannabinoides altamente purificada, libre de THC/libre de CBD, dirigida a enfermedades autoinmunes dominadas por neutrófilos, incluida la artritis reumatoide (AR).

La presentación se realizó junto con Rambam Health Care Campus y sigue un estudio de prueba de concepto en EE. UU. de ocho semanas aprobado por IRB que reportó mejoras significativas en el dolor, el sueño, el bienestar y una reducción de DAS28 de alta a moderada gravedad, sin efectos adversos reportados. La compañía describe RaphaWell como un candidato de administración oral y no psicoactivo, que avanza hacia un lanzamiento comercial inicial.

Raphael Pharmaceutical (OTCQB: RAPH) 는 중성구 우세 자가면역 질환, 포함하여 류마티스 관절염(RA)을 겨냥한 고순도 THC-없음/CBD-없음 카나비노이드 플랫폼에 대해 2025년 11월 17일 임시 특허 출원(No. 63/911,729)을 제출했습니다.

이 출원은 Rambam Health Care Campus와 공동으로 이루어졌으며 IRB 승인을 받은 8주 미국 현장시험(proof-of-concept study)을 따랐고 통증, 수면, 안녕감에서 유의한 개선과 질환 중증도 높은 상태에서 중등도로의 DAS28 감소를 보고했으며 부작용은 보고되지 않았습니다. 회사는 RaphaWell을 경구투여 비-향정신성 후보로서 초기 상용화 출시를 향해 나아가고 있다고 설명합니다.

Raphael Pharmaceutical (OTCQB: RAPH) a déposé une demande de brevet provisoire (No. 63/911,729) le 17 novembre 2025 pour sa plateforme de cannabinoïdes hautement purifiée, sans THC/ sans CBD, ciblant les maladies auto-immunes dominées par les neutrophiles, y compris la polyarthrite rhumatoïde (PR).

Le dépôt a été effectué conjointement avec Rambam Health Care Campus et suit une étude pilote américaine de huit semaines approuvée par l'IRB qui a rapporté des améliorations significatives de la douleur, du sommeil, du bien-être et une réduction du DAS28 de gravité élevée à modérée, sans effets indésirables signalés. L'entreprise décrit RaphaWell comme un candidat administré par voie orale, non psychoactif, en voie de lancement commercial initial.

Raphael Pharmaceutical (OTCQB: RAPH) beantragte am 17. November 2025 eine vorläufige Patentanmeldung (Nr. 63/911,729) für seine hochreine, THC-freie/CBD-freie Cannabinoidplattform, die auf neutrophil-dominierte Autoimmunerkrankungen abzielt, einschließlich rheumatoider Arthritis (RA).

Der Antrag wurde gemeinsam mit dem Rambam Health Care Campus gestellt und folgt einer IRB-genehmigten achtwöchigen US-Ver proof-of-concept-Studie, die signifikante Verbesserungen bei Schmerz, Schlaf, Wohlbefinden und einer Reduktion von DAS28 von hoher zu moderater Krankheitsaktivität berichtete, ohne berichtete Nebenwirkungen. Das Unternehmen beschreibt RaphaWell als oral verabreichten, nicht-psychoaktiven Kandidaten, der sich einem ersten kommerziellen Start nähert.

Raphael Pharmaceutical (OTCQB: RAPH) قدمت طلب براءة اختراع مؤقتة (رقم 63/911,729) في 17 نوفمبر 2025 لمنصتها القنبينية عالية النقاء، خالية من THC/خالية من CBD تستهدف أمراض المناعة الذاتية التي يهيمن عليها النيتروفيل، بما في ذلك التهاب المفاصل الروماتويدي (RA).

كان التقديم مشتركاً مع Rambam Health Care Campus ويتبع دراسة إثبات مفهوم في الولايات المتحدة لمدة ثمانية أسابيع تمت الموافقة عليها من IRB والتي أبلغت عن تحسنات كبيرة في الألم، النوم، الرفاهية وتخفيض DAS28 من شدة عالية إلى متوسطة، مع عدم الإبلاغ عن آثار جانبية. وتصف الشركة RaphaWell كمرشح يُعطى فموياً وغير مهلوس ينتقل نحو الإطلاق التجاري الأول.

Positive
  • Provisional patent filed: 63/911,729 (Nov 17, 2025)
  • Proof‑of‑concept study: DAS28 reduced from high to moderate disease severity
  • No adverse effects reported in the eight‑week IRB‑approved U.S. trial
  • Collaboration with Rambam Health Care Campus under exclusive sponsored research
Negative
  • Patent status: provisional application only, not yet granted
  • Product not yet commercialized; initial launch is planned but not completed
  • Clinical evidence limited to an eight‑week proof‑of‑concept study (no approval cited)

NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Raphael Pharmaceutical Inc. (“Raphael Pharmaceutical” or the “Company”) (OTCQB: RAPH), a clinical-stage biotechnology company developing an innovative research platform based on cannabinoids free of THC and CBD, today announced the filing of a provisional patent application with the United States Patent and Trademark Office.

The application covers the use of the Company’s highly purified cannabinoid-based technology platform in the treatment of neutrophil-dominant autoimmune diseases, including its lead product candidate for rheumatoid arthritis (RA), as well as psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus with neutrophil involvement, and gout.

Raphael previously announced positive proof-of-concept clinical study results for its cannabinoid-based formula for the management of RA. The study was successfully completed in the United States under Institutional Review Board (“IRB”) approval and in compliance with U.S. Food and Drug Administration (“FDA”) regulations. No adverse effects were reported throughout the trial.

The provisional patent application, titled, “Raphael Pharmaceutical, Inc. / Rambam MedTech Formula for Treating Neutrophil-Dominant Autoimmune Diseases (including RA)” (No. 63/911,729), was filed jointly with the Medical Cannabis Research and Innovation Center (MCRIC) at Rambam Health Care Campus – one of the world’s leading university hospitals.

Raphael and Rambam have collaborated under a sponsored research agreement signed in 2019, granting Raphael exclusive access to Rambam’s world-class cannabinoid research and development program, led by Dr. Igal Louria-Hayon, who serves as both Chief Technology Officer (CTO) of Raphael and Head of the Medical Cannabis Research and Innovation Center at Rambam Health Care Campus.

Dr. Louria-Hayon is a global expert in cannabinoid research and cell-to-cell communication.  

“The filing of this provisional patent application represents a major milestone for Raphael and our partner Rambam,” said Shlomi Pilo, President and CEO of Raphael Pharmaceutical. “It is a critical step forward in protecting our innovative cannabinoid-based technology platform and moving toward the initial launch of our commercial product “RaphaWell,” which is designed for targeted, orally accessible delivery to patients within the RA community in the U.S.”

Dr. Louria-Hayon added, “Based on our research to date, we believe Raphael Pharmaceutical’s proprietary formula has the potential to offer a safe and cost-effective option that significantly reduces inflammation, and severe symptoms for millions of people suffering from rheumatoid arthritis.   As reflected in the scope of the provisional patent, we also believe this highly purified cannabinoid platform may have broader applications in other chronic inflammatory conditions.”

Key Findings from the Proof-of-Concept Clinical Study

Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from the hemp plant, entirely free of psychoactive cannabis components, with exceptional anti-inflammatory potential.

The formulation is administered orally and demonstrated no side effects.

It is designed to interact with the human endocannabinoid system by activating cannabinoid receptors expressed on immune cells.

In 2025, the Company announced positive Proof-of-Concept clinical results for the use of its cannabinoid-based formula in the treatment of RA.

The eight-week IRB-approved study conducted in the United States showed significant improvements in pain, sleep quality, and overall well-being, which became evident as early as week four and persisted through the end of the trial.

This included a reduction in DAS28 scores from high disease activity to moderate disease severity.

About Raphael Pharmaceutical Inc.

Raphael Pharmaceutical Inc. (“Raphael”) (OTCQB: RAPH) is a clinical-stage biotechnology company focused on developing an innovative research platform based on THC-free and CBD-free cannabinoids for the treatment of inflammatory diseases.   The Company’s lead product candidate, RaphaWell, is a highly purified non-psychoactive cannabinoid formulation developed for targeted, orally accessible delivery to patients, designed specifically for the treatment of rheumatoid arthritis, with no reported side effects.

For more information, please visit: https://www.raphaelpharmaceutical.com/

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.   These statements are based on current expectations, assumptions, and projections about the Company’s business and are not guarantees of future performance.   Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied herein.   Additional information about the risks facing the Company’s business is available in its most recent Annual Report on Form 10-K and subsequent filings on Forms 10-Q and 8-K with the U.S. Securities and Exchange Commission (SEC).   Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

Investor Contact:

The Equity Group        
Devin Sullivan
Managing Director                
T: (212) 836-9608        
dsullivan@theequitygroup.com

Conor Rodriguez
Associate        
T: (212) 836-9628        
crodriguez@theequitygroup.com


FAQ

What did Raphael Pharmaceutical (RAPH) file on November 17, 2025?

Raphael filed a provisional patent application (No. 63/911,729) for its THC‑free/CBD‑free cannabinoid platform targeting neutrophil‑dominant autoimmune diseases.

What were the key results of Raphael's eight‑week RA proof‑of‑concept study in 2025?

The IRB‑approved U.S. study showed significant improvements in pain, sleep, overall well‑being and a DAS28 reduction from high to moderate, with no adverse effects reported.

How is Raphael collaborating with Rambam on the RAPH patent filing?

The provisional patent was filed jointly with Rambam Health Care Campus under a sponsored research agreement granting Raphael exclusive access to Rambam's cannabinoid R&D.

Does the provisional patent mean RaphaWell is approved for sale?

No; the filing secures provisional patent protection but does not represent regulatory approval or commercialization.

Which diseases does Raphael's provisional patent cover for RAPH's cannabinoid platform?

The application covers neutrophil‑dominant autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, lupus with neutrophil involvement, and gout.
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