<img src="https://ml.globenewswire.com/Resource/Download/56e13ce4-e7d9-45ee-85e9-26feec9b7c6f?size=2" nborder="0" align="left" hspace="5" vspace="5" title="logo.png" alt="Oryzon Genomics, S.A."/><ul type="disc"><li style="margin-bottom:6pt;">In first line AML (ALICE-2 trial), iadademstat with azacitidine and venetoclax showed high levels of clinical activity, with 100% (18/18) ORR, 89% (16/18) CRc and 78% (14/18) CR, and continued to demonstrate a favorable safety profile</li><li style="margin-bottom:6pt;">All patients with TP53 or RAS pathway mutations achieved a complete response, showcasing the activity of the iadademstat combination across genomically defined adverse-risk subgroups and its potential in these populations</li><li style="margin-bottom:6pt;">In FLT3-mutated refractory-relapsed patients (FRIDA trial), iadademstat with gilteritinib continued to show a favorable safety profile and a high CRc rate of 67% </li></ul> MADRID and CAMBRIDGE, Mass., June 11, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today presented updated positive clinical data from two clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia (AML) at the 2026 European Hematology Association (EHA) Annual Congress. “We are encouraged by the sustained strength and consistency of the data from both the ALICE-2 and FRIDA trials,” said Carlos Buesa, Chief Executive Officer of Oryzon Genomics. “With over 80% of patients now enrolled in ALICE-2, the favorable safety profile and strong efficacy signals of iadademstat in newly diagnosed, unfit AML patients reinforce our confidence in this combination approach, including within genomically defined adverse-risk populations such as TP53-mutated and RAS pathway–mutated AML. These results are consistent with prior findings in TP53-mutated patients in our ALICE trial, where the combination of iadademstat and azacitidine doubled median overall survival compared with historical rates. As enrollment continues, we anticipate reporting final data by year-end and advancing toward a potential registrational study in first-line AML by 2027, with a focus on adverse-risk populations.” Ana Limón, Senior Vice President of Clinical Development and Global Medical Affairs at Oryzon, added: “Historically, with azacitidine plus venetoclax, one third of first line AML patients do not respond, and the depth of response is variable, underscoring the need for novel triplet strategies, particularly for patients without targetable mutations. The maturing data from both trials continue to reinforce the strength of LSD1 inhibition as an add-on approach in AML. In addition to the high ORR and CR rates observed to date in the ALICE-2 trial, treatment with the iadademstat-azacitidine-venetoclax triplet has enabled a high proportion of patients to transition to allogeneic hematopoietic cell transplantation (HCT), potentially improving long-term survival. Overall, the safety and efficacy observed across both trials support further clinical development.” Data Summary ALICE-2 Phase Ib clinical trial (NCT06357182) investigating iadademstat in combination with azacitidine and venetoclax in newly diagnosed AML <ul type="disc"><li style="margin-bottom:10pt;">High rates of activity, with a 100% (18/18) overall response rate (ORR), 89% (16/18) composite complete remission (CRc) rate and 78% (14/18) complete response (CR) rate.</li><li style="margin-bottom:10pt;">CRs occur early, most of them in cycle 1.</li><li style="margin-bottom:10pt;">Efficacy was observed across different genomic risk groups, including TP53 and RAS pathway mutations and patients with complex karyotypes, all considered adverse risk.</li><li style="margin-bottom:10pt;">Patients with TP53-mutated disease (2/2) attained CR and showed a reduction in TP53 variant allele frequency (14% to undetected and 22% to 1%, respectively).</li><li style="margin-bottom:10pt;">All patients with RAS pathway mutations (3/3) achieved CR.</li><li style="margin-bottom:10pt;">After a median follow-up of 8 months, median overall survival (OS) and event-free survival (EFS) were not reached; estimated 12-month OS and EFS were 79% and 71%, respectively.</li><li style="margin-bottom:10pt;">9 patients successfully transitioned to allogeneic HCT, with an estimated 12-month OS of 88%.</li><li style="margin-bottom:10pt;">The iadademstat-azacitidine-venetoclax combination continues to show a favorable safety profile. </li></ul> FRIDA Phase Ib clinical trial (NCT05546580) investigating iadademstat in combination with gilteritinib in FLT3‑mutated relapsed/refractory AML <ul type="disc"><li style="margin-bottom:10pt;">The poster reports data from the expansion cohort at the selected pharmacological active dose (PAD, 75 ug iadademstat); 23 patients have been enrolled at this dose, with 18 being evaluable for response.</li><li style="margin-bottom:10pt;">High CRc rate of 67% (12/18) in a heavily pre-treated population.</li><li style="margin-bottom:10pt;">Iadademstat plus standard of care (SoC) treatment gilteritinib demonstrated a manageable safety profile, without adding toxicity to the SoC. </li></ul> About ALICE-2 ALICE-2 (NCT06357182) is a Phase Ib investigator-initiated study sponsored by Oregon Health &amp; Science University (OHSU) in newly diagnosed AML. It is evaluating treatment with iadademstat in combination with azacitidine and venetoclax, the standard of care, in newly diagnosed unfit patients. The study’s primary endpoint is the incidence of dose-limiting toxicities (DLTs). Secondary endpoints include efficacy measurements such as composite complete remission (CRc: complete remission [CR] + CR with partial hematologic recovery [CRh] + CR with incomplete recovery [CRi]), and overall response rate (ORR: CRc + morphologic leukemia free state [MLFS] + partial remission [PR]). The trial plans to enrol 24 patients to achieve 21 evaluable patients. About FRIDA FRIDA (NCT05546580) is a Phase Ib clinical study sponsored by Oryzon. It is evaluating iadademstat in combination with gilteritinib for the treatment of FLT3-mutant relapsed/refractory AML. The primary endpoints are incidence of treatment emergent adverse events (TEAEs) and determination of the recommended Phase II dose (RP2D). Secondary endpoints include response rates (CR, CRh, CRi, MLFS, CRc), event-free survival (EFS), and overall survival (OS).  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, with several ongoing Phase I and II studies and which 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 <a href="https://www.globenewswire.com/Tracker?data=b55pNai-QJygX7OnIExr5ig-u2raju4fG118582t40GELLQ7CVKxSn34203ie4HJI9MgA4kxyujqKZRhb8eYvg==" rel="nofollow" target="_blank" title="www.oryzon.com">www.oryzon.com</a> About Iadademstat Iadademstat (ORY-1001) is an oral, highly selective inhibitor of the epigenetic enzyme LSD1, with potent differentiating effect in hematologic cancers. Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L acute myeloid leukemia (AML) patients (ALICE trial). Iadademstat is currently being evaluated in combination with azacitidine and venetoclax in 1L AML in the ALICE-2 trial, an investigator-initiated study (IIS) led by OHSU, and in combination with gilteritinib in the company-sponsored Phase Ib FRIDA trial in relapsed/refractory FLT3-mutant AML, with highly encouraging preliminary safety and efficacy data in both trials reported at EHA-2026: 100% overall response rate (ORR) and 89% composite complete remission rate (CRc), with 78% strict CR in 1L AML, and 67% CRc in R/R Flt3-mut AML. Additional studies in hematologic malignancies include an IIS in myelodysplastic syndrome (MDS) and National Cancer Institute (NCI)-sponsored trials in myeloproliferative neoplasms and 1L AML conducted under the Cooperative Research and Development Agreement (CRADA) between Oryzon and the NCI. Beyond hematological cancers, iadademstat is being evaluated in extensive stage small cell lung cancer (ED-SCLC) in a Phase I/II randomized trial in 1L in combination with immune checkpoint inhibition (ICI) sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center, and an IIS trial in combination with ICI and radiotherapy. Oryzon has also expanded iadademstat into non-oncological hematology indications, with ongoing trials in sickle cell disease and essential thrombocythemia. Iadademstat has orphan drug designation for AML in the US and EU and for SCLC in the US. 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. <table style="border-collapse: collapse; width:100%; border-collapse:collapse ;"><tr><td style="max-width:33%; width:33%; min-width:33%;;text-align: justify ; vertical-align: middle; vertical-align: top ; ">Spain </td><td style="max-width:33%; width:33%; min-width:33%;;text-align: justify ; vertical-align: middle; vertical-align: top ; ">Oryzon </td><td style="max-width:33%; width:33%; min-width:33%;;text-align: justify ; vertical-align: middle; vertical-align: top ; ">IR &amp; Media, Europe &amp; US</td><td style="max-width:1%; width:1%; min-width:1%;;text-align: justify ; vertical-align: middle; vertical-align: top ; "> </td></tr><tr><td style="vertical-align: top ; ">Patricia Cobo/Mario Cordera </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; ">Emili Torrell </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; ">Sandya von der Weid </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; "> </td></tr><tr><td style="vertical-align: top ; ">Atrevia </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; ">Chief BD Officer </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; ">LifeSci Advisors, LLC </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; "> </td></tr><tr><td style="vertical-align: top ; ">+34 91 564 07 25  +34 673 33 97 65 </td><td style="vertical-align: top ; ">+34 93 515 1313</td><td style="vertical-align: top ; ">+41 78 680 05 38</td><td style="vertical-align: top ; "> </td></tr><tr><td style="vertical-align: top ; ">pcobo@atrevia.com  mcordera@atrevia.com </td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; ">etorrell@oryzon.com</td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; ">svonderweid@lifesciadvisors.com</td><td style="text-align: justify ; vertical-align: middle; vertical-align: top ; "> </td></tr></table> <img alt="" src='https://ml.globenewswire.com/media/ZWU0Zjc5NjQtZWZjZS00MGRmLWI3OGUtOTViNTJjOTEwODFlLTUwMDA2Njc1OC0yMDI2LTA2LTExLWVu/tiny/Oryzon-Genomics-S-A-.png' referrerpolicy='no-referrer-when-downgrade' />

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ORYZON Presents Updated Positive Clinical Data for Iadademstat in Acute Myeloid Leukemia (AML) at European Hematology Association (EHA) 2026 Annual Congress

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