Earnings release
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Pioneering Personalized ORYZON Medicine in Epigenetics PRESS RELEASE 2021 ORYZON reports results and corporate update for quarter ended September 30 , 2021 - MADRID , SPAIN and CAMBRIDGE , MA , UNITED STATES , October 28th , 2021 – Oryzon Genomics , S.A. ( ISIN Code : ES0167733015 , ORY ) , a clinical - stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need , today reported financial results for the third quarter of 2021 and provided an update on recent developments . Dr Carlos Buesa , Oryzon's Chief Executive Officer , said : " Oryzon continued to make vigorous progress on our clinical pipeline this quarter . In oncology , after the positive data from iadademstat's Phase II trial in AML published at EHA in June , ALICE is now fully recruited . Also , we have unfolded our registrational strategy in AML and in ED - SCLC with two carefully designed trials , FRIDA and STELLAR , that we believe may merit accelerated approval . " " Our CNS pipeline has reached important milestones . After FDA's IND approval to start vafidemstat's Phase Ilb PORTICO in BPD , we have started a vigorous recruitment in the US that will complement the one being made in Europe . We have also activated multiple clinical sites for EVOLUTION , our Phase llb in schizophrenia and we expect to start recruitment very soon . Also , together with the most prestigious KOLS in the space , we are progressing in the design of HOPE , the first randomized Phase I / II personalized medicine trial targeting LSD1 , in particular in Kabuki Syndrome patients . The extent of the planned clinical activities highlight our strong commitment for US clinical and regulatory activities . We finished this third quarter with a solid cash position of $ 35.83 million , which provides funding for further development of our exciting pipeline until 1Q 2023. " Third Quarter and Recent Highlights ladademstat in oncology : ➤ Phase II ALICE trial , investigating iadademstat in combination with azacitidine in acute myeloid leukemia ( AML ) , is fully enrolled , with a total of 36 patients . Preliminary data corresponding to the 30 months of the study were presented at the EHA 2021 congress last June , showing robust signs of clinical efficacy , with ORR of 83 % , of which 67 % were CR / CRI , as well as a good safety profile of the combination of iadademstat and azacitidine . Five patients with remissions greater than one year were reported and the longest remission at that time was 858 days , currently still ongoing . The company plans to present a new clinical update on ALICE at the ASH 2021 congress . New trials in combination in AML and solid tumors are under preparation . In AML , the company is planning to launch FRIDA , an open - label , multicenter Phase Ib / II trial of iadademstat in combination with gilteritinib in FLT3 mutated relapsed / refractory AML patients . In small cell lung cancer ( SCLC ) , the STELLAR trial is in preparation . STELLAR is a randomized , multicenter Phase Ib / II