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

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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.

 
ORYZON GENOMICS SA
BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands US $)
         
  March 31st,
2018
    March 31st,
2017
         
Cash and cash equivalents 37,848     22,612
Marketable securities 224     7,207
Total Assets 72,720     55,971
         
Deferred revenue 0     0
Total Stockholders' equity 41,009     22,983
         

 

       
ORYZON GENOMICS SA
STATEMENTS OF OPERATIONS (UNAUDITED)
(US $, amounts in thousands except per share data)
       
    Three Months Ended
March 31,
   
    2018 2017
       
Collaboration Revenue   0 18
       
Operating expenses:      
Research and Development 2,334 1,564
General and administrative 887 967
       
Total operating expenses 3,221 2,531
       
Loss from Operations   -3,221 -2,513
       
Other income, net   2,458 1,509
       
Net Loss   -763 -1,004
       
Net Financial & Tax   -499 -374
       
Net Result   -1,262 -1,378
 
     
Loss per share allocable to common stockholders:
Basic   -0.04 -0.05
Diluted   -0.04 -0.05
       
Weighted average Shares outstanding  
Basic     33,492,804    27,728,838 
Diluted     33,492,804    27,728,838 
       

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
This communication contains forward-looking information and statements about Oryzon Genomics, S.A., including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates" and similar expressions. Although Oryzon Genomics, S.A. believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon Genomics, S.A. shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon Genomics, S.A., that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon Genomics, S.A. to the Comisión Nacional del Mercado de Valores, which are accessible to the public. Forward-looking statements are not guarantees of future performance. The auditors of Oryzon Genomics, S.A, have not reviewed them. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon Genomics, S.A. or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon Genomics, S.A. on the date hereof. Except as required by applicable law, Oryzon Genomics, S.A. does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of the Company's securities to be made in the United States will be made by means of a prospectus that may be obtained from the Company or the selling security holder, as applicable, that will contain detailed information about the Company and management, as well as financial statements.

     
US Contact: Spain: The Company:
The Trout Group ATREVIA Emili Torrell
Thomas Hoffmann Patricia Cobo/Luis Rejano BD Director
+1 646 378 2932 +34 91 564 07 25 +34 93 515 13 13
thoffmann@troutgroup.com pcobo@atrevia.com
lrejano@atrevia.com
etorrell@oryzon.com

 


 

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