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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.

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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)

News Market Reaction

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On the day this news was published, RAPH declined NaN%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

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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