ORYZON Reports Financial Results and Corporate Update for the 1st Quarter 2018

MADRID, Spain and CAMBRIDGE, Mass., May 09, 2018 (GLOBE NEWSWIRE) -- Oryzon Genomics (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 first quarter of 2018 and provided an update on the Company's recent developments.

The company has worked intensively during this quarter to finalize the preparations of two Phase IIa clinical trials with ORY-1001 in Acute Myeloid Leukemia and in Small Cell Lung Cancer, after having recovered all the rights to the molecule at no cost at the end of January. The company is planning to submit these new clinical trials  shortly to obtain the authorization of the regulatory agencies, and  will inform in this regard in due course.

The Phase I clinical trial of ORY-2001, a dual inhibitor of LSD1 and MAOB, in 106 healthy volunteers to evaluate its potential in Alzheimer's disease (AD) and Multiple Sclerosis (MS) allowed to characterize its safety and define the doses to be used in the next Clinical Phases II with patients. It also allowed to establish the capacity of the drug administered orally to penetrate into the brain.

This program recruited its first patient in the Phase IIa trial in MS, SATEEN, during the month of January. During the first quarter the company also submitted to the Spanish Medicines Agency (AEMPS) and other European countries a clinical trial application (CTA) to obtain approval for a Phase IIa clinical study of ORY-2001 in AD patients in mild and moderate stages. This clinical trial was approved by the AEMPS at the beginning of April.

The company has also made progress in new preclinical experiments with ORY-2001 and in the characterization of the mechanism of action in other indications of the Central Nervous System that the company considers may be a relevant option in the future clinical development of the drug. Among them it is worth to mention the treatment of behavioral alterations present in patients suffering from diseases such as Parkinson's, autistic spectrum disorder, depression and others. These data may substantially broaden the potential clinical development of ORY-2001 beyond the current indications of AD and MS that the company is advancing in clinical trials.

ORY-3001, the company’s third LSD1 inhibitor, in development for the treatment of a non-oncological, yet undisclosed, orphan disease, has successfully completed the regulatory toxicology necessary to obtain the permits to start clinical studies. 

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

First Quarter Highlights

• In JANUARY 2018 ORYZON announced first patient In in ORY-2001 MS Phase IIa trial SATEEN and presented new preclinical data on ORY-2001 in MS at the third annual ACTRIMS Forum 2018 in San Diego
• In FEBRUARY 2018  ORYZON appointed clinical development leader Lori A. Kunkel, M.D., as a Scientific Advisor
• In FEBRUARY 2018 ORYZON revamped its Board with an expert in Biomedicine and Epigenetics in the US industry.
• In MARCH 2018 ORYZON announced publication of a paper in Cancer Cell establishing the relevance of ORY-1001 as an antileukemic differentiating drug.
• In APRIL 2018 ORYZON received approval from the Spanish Regulatory Authorities to start ETHERAL: a Phase IIa clinical trial in Alzheimer’s Disease with ORY-2001

Financial Update: First Quarter 2018 Financial Results

Collaboration revenue was $0.00 million for the last 3 months ended March 31, 2018 and $0.02 million for the last 3 months ended March 31, 2017. The 1st quarter 2017 revenues was the last accrual of the Roche license 2015 milestone.

Research and development (R&D) expenses established themselves at $2.3 million for the last 3 months ended March 31, 2018 compared to the $1.6 million for the last 3 months ended March 31, 2017. The $0.7 million increase was driven primarily by accelerated R&D efforts to start ETHERAL - a Phase IIa clinical trial with ORY-2001 in Alzheimer’s Disease, and SATEEN - a Phase IIa clinical trial with ORY-2001in Multiple Sclerosis.

General and administrative expenses were $0.9 million for the last 3 months ended March 31, 2018 and $1.0 million for the last 3 months ended March 31, 2017

Net loss of $1.3 million (-$0.04 per share) for the last 3 months ended March 31, 2018 represents an improvement of 7% compared to the net loss of $1.4 million for the last 3 months ended March 31, 2017 (-$0.05 per share).

Cash, cash equivalents and marketable securities totaled $38.1 million as of March 31, 2018, compared to $29.8 million as of March 31, 2017.

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. The company has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. The company has offices in Spain and USA. For more information, visit www.oryzon.com.

FORWARD-LOOKING STATEMENTS
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