Earnings release
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Pioneering Personalized ORYZON Medicine in Epigenetics PRESS RELEASE 2021 ORYZON reports results and corporate update for first half ended June 30 , 2021 MADRID , SPAIN and CAMBRIDGE , MA , UNITED STATES , July 29th , 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 first half of 2021 and provided an update on recent developments . Dr Carlos Buesa , Oryzon's Chief Executive Officer , said : “ Oryzon continued to make strong progress on our clinical pipeline this quarter , with very positive data from iadademstat's Phase II trial in acute myeloid leukemia . The 30 - month data we recently reported continued to confirm a very robust percentage of responses , with responses also maturing in longer times of remission , extending survival . We believe the combination approaches with iadademstat will increase therapeutic options for acute myeloid leukemia patients in first line , as well as for refractory or intolerant patients who have received BCL2 inhibitors as first line . " Our CNS pipeline reached important milestones with Investigational New Drug approval from the U.S. Food and Drug Administration for our Phase IIb trial with vafidemstat in Borderline Personality Disorder , PORTICO and Clinical Trial Application approval of our Phase IIb trial with vafidemstat in Schizophrenia , EVOLUTION , in Europe . The initiation of PORTICO also highlights the importance of our growing U.S. clinical activities . Furthermore , vafidemstat also showed clear anti - inflammatory responses in moderate and severe COVID - 19 patients in our two - arm , randomized Phase II study , ESCAPE . We finished this second quarter with a reinforced cash position of $ 40.1 million , which provides funding for further development of our exciting pipeline until 1Q 2023. " First Half and Recent Highlights ladademstat in oncology : ➤ Phase II ALICE trial , investigating iadademstat in combination with azacitidine in acute myeloid leukemia ( AML ) , continues recruitment . The preliminary results corresponding to the 30 months of the study , presented at the EHA 2021 congress , show robust signs of clinical efficacy , with ORR of 83 % , of which 67 % are CR / CRI . Five patients with remissions greater than one year were reported and the longest remission of 858 days , is still ongoing . The responses appear early . The combination of iadademstat and azacitidine continues to show a good safety profile . The company plans to present a new clinical update on ALICE at the ASH 2021 congress . U.S. Food and Drug Administration ( FDA ) Orphan Drug Designation granted to iadademstat for the treatment of AML . The drug now has orphan designation in both U.S. and EU . New trials in combination in AML and solid tumors are under preparation . The company believes that there is potential for fast market regulatory paths in both areas . Oryzon expects to announce