ORYZON Reports Financial Results and Corporate Update for the 4th Quarter and Year Ended December 31, 2018

-$0.04/share for the 12 months ended December 31st

MADRID, Spain and CAMBRIDGE, Mass., Feb. 15, 2019 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today reported financial results for the fourth quarter of 2018 and provided an update on the Company's recent developments.

R&D investments of €8.5 million for the 12 months ended December 31, 2018 have permitted Oryzon to significantly advance its clinical portfolio.  

In this fourth quarter, the company has enrolled the first patients in two new clinical studies in leukemia and small cell lung cancer with Iadademstat (ORY-1001). ALICE is a single arm Phase II study of Iadademstat in first line acute myeloid leukemia elderly patients who are not eligible for conventional therapy, in combination with the hypomethylating agent Azacitidine. The trial will study the safety and clinical efficacy of the combination. CLEPSIDRA is a single arm Phase II trial of Iadademstat in second-line patients with small cell lung cancer in combination with platinum / etoposide. In CLEPSIDRA, the patients to be included are screened for proprietary tumor biomarkers identified by the scientists of the company. The trial will study the safety and clinical efficacy of the combination.

The clinical development of Vafidemstat (ORY-2001) has also proceeded timely. The Phase IIa clinical trial of Vafidemstat in Multiple Sclerosis (MS), SATEEN, has continued the recruitment during the fourth quarter. The Phase IIa clinical trial of Vafidemstat in mild and moderate Alzheimer's patients, ETHERAL, authorized by the Spanish, French and British Regulatory Agencies, is also actively recruiting patients in Spain, France and the United Kingdom.

There has also been progress in new preclinical experiments with Vafidemstat (ORY-2001) and in the characterization of the Mechanism of Action in other indications in Central Nervous System diseases that the company considers may be a relevant complementary option in the clinical development of the drug. Among them, the treatment of behavioral alterations present in patients with diseases such as borderline personality disorder, autistic syndrome, ADHD, depression and others. These data can significantly expand the potential clinical development of Vafidemstat (ORY-2001) beyond the current indications of AD and MS in which the company is currently advancing clinically. In this line the company has obtained the approval of the Spanish Medicines Agency (AEMPS) to start REIMAGINE: a Phase IIa “basket” clinical trial to evaluate the effect of Vafidemstat to treat aggressiveness in patients in three psychiatric diseases and two neurodegenerative diseases. Recruitment has progressed satisfactorily in several of the cohorts of this basket trial.

The company's third LSD1 inhibitor, ORY-3001, in preclinical phase for non-oncological indications, has successfully completed the regulatory toxicology necessary to obtain the permits to start clinical studies.

In addition, progress has been made in programs in earlier phases.

In summary, the company has two "first-in-class" epigenetic experimental molecules in five Phase IIa clinical trials in humans and a third compound that has completed the regulatory preclinical phase.

Fourth Quarter Highlights & relevant post-closing events

• In OCTOBER 2018 ORYZON announces first patient enrolled in REIMAGINE: a Phase IIa clinical trial with Vafidemstat (ORY-2001) in aggressiveness.
• In OCTOBER 2018 ORYZON receives approval to start CLEPSIDRA: a Phase IIa clinical trial with Iadademstat (ORY-1001) in small cell lung cancer.
• In OCTOBER 2018 ORYZON raises €13 million through a Private Placement with US and European Investors issuing of 4,961,833 new common shares, at a price of €2.62 per share, representing a 12% discount on the closing price of the last three trading days.
• In NOVEMBER 2018 ORYZON announces First-Patient-in in ALICE: a Phase IIa Clinical Trial with Iadademstat (ORY-1001) in Acute Myeloid Leukemia patients.
• In DECEMBER 2018 ORYZON announces First-Patients-in in CLEPSIDRA: a Phase IIa clinical trial Iadademstat (ORY-1001) in Small Cell Lung Cancer patients.
• In DECEMBER 2018 ORYZON receives a new $1.14million public grant to explore new indications for epigenetic inhibitors.
• In DECEMBER 2018 The Technical Advisory Committee of the IBEX INDICES has decided to incorporate Oryzon to the Ibex Small Cap Index.

Financial Update: Fourth Quarter  2018 Financial Results

Research and development (R&D) expenses were $2.3 and $8.5 million for the 3 and 12 months ended December 31, 2018 compared to $1.3 and $6.4 million for the 3 and 12 months ended December 31, 2017. The $2.1 million increase was driven primarily to accelerate the operations related with the execution of clinical trials.

General and administrative expenses were $0.5 and $3.0 million for the 3 and 12 months ended December 31, 2018, compared to $1.2 and $4.5 million for the 3 and 12 months ended December 31, 2017

Net loss of $0.7 and $3.3 million for the 3 and 12 months ended December 31, 2018 represents a decrease of 50% and 36% compared to a net loss of $1.4 and $5.2 million for the 3 and 12 months ended December 30, 2017.

Negative Net Result of $1.3 million (-$0.04 per share) for the 12 months ended December 31, 2018 as a consequence of $3.1 million non-recurrent R&D tax deductions, compared to a negative net result of $6.2 million for the 12 months ended December 31, 2017 (-$0.20 per share).

Cash, cash equivalents and marketable securities totaled $39.5 million as of December 31, 2018, compared to $42.1 million as of December 31, 2017.

On October 30th the company announced a Private Placement with US and European Investors and issued 4,961,833 new common shares, which represents gross proceeds of €13 million (circa $14.8 million at the exchange rate of that day).

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds Vafidemstat and Iadademstat in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com

FORWARD-LOOKING STATEMENTS
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