ORYZON Reports Results and Corporate Update for First Half Ended June 30, 2021
MADRID, Spain and CAMBRIDGE, Mass., July 29, 2021 (GLOBE NEWSWIRE) -- 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
Iadademstat in oncology:
Vafidemstat in neurological and inflammatory disease:
Financial Update: First Half 2021 Financial Results
Research and development (R&D) expenses were $2.9 and $7.3 million for the quarter and 6 months ended June 30, 2021, compared to $2.7 and $7.1 million for the quarter and 6 months ended June 30, 2020.
General and administrative expenses were $1.20 and $2.5 million for the quarter and 6 months ended June 30, 2021, compared to $0.9 and $1.8 million for the quarter and 6 months ended June 30, 2020.
Net losses were $1.9 and $3.9 million for the quarter and 6 months ended June 30, 2021, compared to net losses of $1.3 and $2.5 million for the quarter and 6 months ended June 30, 2020. This is due to a higher investment in research and non-capitalized development of the ESCAPE clinical trial and non-recurring expenses. The result is in accordance with the specificity of the biotechnology business model, in the development phase of the Company, with a long-term maturation period for its products, and without recurrent income.
Negative net result of $1.2 million (-$0.02 per share) for the first 6 months ended June 30, 2021, compared to a negative net result of $1.5 million (- $0,03 per share) for the first 6 months ended June 30, 2020.
Cash, cash equivalents and marketable securities totaled $40.1 million as of June 30, 2021, compared to $54.9 million as of June 30, 2020.
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