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ORYZON further strengthens vafidemstat’s patent portfolio with new decisions to grant

  • New patent allowances in South Korea, Mexico, New Zealand and the Philippines
  • Further expand IP protection across BPD, ASD, aggression and social withdrawal

MADRID and CAMBRIDGE, Mass., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that it has received new decisions to grant for patent applications in South Korea, the Philippines, New Zealand and Mexico, further strengthening its extensive patent portfolio for vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for psychiatric and neurodevelopmental disorders.

The Korean and Philippine Patent Offices have issued decisions to grant for patent applications KR10-2021-7028149 and PH1-2021-552251, respectively, both titled “Methods of treating borderline personality disorder.” The allowed claims cover the use of vafidemstat for the treatment of non-aggressive symptoms of borderline personality disorder (BPD), complementing Oryzon’s patent protection relating to aggression. Corresponding patents have already been granted or allowed in Australia, Canada, Europe, Hong Kong, Japan, Malaysia, Mexico, Russia, Singapore, South Africa and the United States. The U.S. patent is expected to remain in force until at least 2043, including 1,095 days of Patent Term Adjustment, while the non-U.S. patents are expected to remain in force until at least 2040, excluding any potential patent term extensions or equivalent adjustments.

In addition, the New Zealand Patent Office has issued a decision to grant for patent application NZ760665, which belongs to a separate patent family covering the use of vafidemstat for the treatment of aggression and social withdrawal. Corresponding patents have already been granted or allowed in Australia, Canada, Europe, Hong Kong, Israel, Japan, South Korea, Malaysia, the Philippines and Russia, with additional applications pending in other jurisdictions. These patents are expected to remain in force until at least 2038, excluding any potential patent term extensions or adjustments.

Oryzon has also received a decision to grant from the Mexican Patent Office for patent application MX/A/2022/002420, titled “Methods of treating autism spectrum disorder”. The allowed claims cover the use of vafidemstat for the treatment of certain non-aggressive symptoms of autism spectrum disorder (ASD). A corresponding patent has already been granted in Japan, with applications pending in other countries. Once granted, this Mexican patent will remain in force until at least 2040, excluding any potential patent term extensions.

“These new patent allowances represent another important step in strengthening the global intellectual property protection of vafidemstat across multiple therapeutic indications,” said Neus Virgili, Oryzon's Chief IP Officer. “By expanding our patent coverage in international markets and across distinct clinical applications, we continue to build a broad and durable IP portfolio that supports vafidemstat's long-term development and commercial potential.”

Vafidemstat is in advanced clinical development for the treatment of aggression in psychiatric disorders, with a Phase III trial in preparation for aggression in BPD. The compound is also being evaluated in the ongoing randomized, double-blind, placebo-controlled Phase IIb EVOLUTION trial targeting negative symptoms of schizophrenia, among which social withdrawal is one of the most prominent. In parallel, Oryzon is expanding vafidemstat's development into genetically defined patient populations through its precision medicine strategy, including a recently approved Phase II clinical trial in ASD focused on patients with Phelan-McDermid syndrome (PMS).

About Oryzon
Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, which is being evaluated in several ongoing Phase I and II studies and has demonstrated strong preliminary clinical activity in acute myeloid leukemia, including a 100% overall response rate (ORR) in first-line AML; and vafidemstat, its lead CNS program, which is Phase III–ready in borderline personality disorder (BPD). In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which the Company has nominated ORY-4001 as a clinical candidate for potential development in Charcot–Marie–Tooth disease (CMT), amyotrophic lateral sclerosis (ALS), and other neurological disorders. The Company also operates a robust platform for biomarker identification and target validation across malignant and neurological diseases. For more information, visit www.oryzon.com

About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor with the potential to address psychiatric and neurodevelopmental disorders through epigenetic modulation. In preclinical studies, vafidemstat has demonstrated effects on cognition, neuroinflammation, aggression, and social behavior, as well as neuroprotective and anti-inflammatory activity across multiple CNS disease models. Oryzon has completed several Phase II clinical trials with vafidemstat, including the REIMAGINE and REIMAGINE-AD trials in aggression in patients with different psychiatric disorders and in aggressive/agitated patients with moderate or severe AD, respectively, with positive clinical results reported in both trials. Following completion of the global randomized double-blind Phase IIb PORTICO trial in borderline personality disorder (BPD), vafidemstat is advancing towards Phase III development for the treatment of aggression in BPD, with a Phase III trial currently in preparation. Vafidemstat is also being evaluated in the ongoing double-blind, randomized, placebo-controlled Phase IIb EVOLUTION trial in schizophrenia, targeting negative symptoms. In addition, Oryzon is deploying a CNS precision medicine approach with vafidemstat in genetically defined patient subpopulations of certain CNS disorders, as well as in neurodevelopmental syndromes, including the recently approved HOPE-2 clinical trial in Phelan-McDermid Syndrome.

FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration.

Spain Oryzon IR & Media, Europe & US
Patricia Cobo/Mario Cordera Emili Torrell Sandya von der Weid
Atrevia Chief BD Officer LifeSci Advisors, LLC
+34 91 564 07 25
+34 673 33 97 65
+34 93 515 1313 +41 78 680 05 38
pcobo@atrevia.com
mcordera@atrevia.com
etorrell@oryzon.com svonderweid@lifesciadvisors.com

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