-$0.01/share for the 9 months ended September 30th

MADRID, Spain and CAMBRIDGE, Mass., Nov. 02, 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 third quarter of 2018 and provided an update on the Company's recent developments.

R&D investments of € 5.4 million for the 9 months ended September 30, 2018 have permitted Oryzon to significantly advance its clinical portfolio.  

In this third quarter, the company has obtained authorization from the Regulatory Agencies to conduct 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. The patients to be included will be first 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 company will inform about the operational start of these two studies in due time.

The clinical development of the second molecule, 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 third 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 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 already begun 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.

Third Quarter Highlights & relevant post-closing events

  • In SEPTEMBER 2018 ORYZON receives approval to start ALICE: a Phase IIa clinical trial with Iadademstat (ORY-1001) in AML.
  • In SEPTEMBER 2018 ORYZON receives approval to begin REIMAGINE: a Phase IIa clinical trial with Vafidemstat (ORY-2001) in aggressiveness.
  • 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 EUR 13 Million through a Private Placement with US and European Investors issuing of 4,961,833 new common shares, at a price of EUR 2.62 per share, representing a 12% discount on the closing price of the last three trading days

Financial Update: Third Quarter 2018 Financial Results

Research and development (R&D) expenses were $1.9 and $6.2 million for the first 3 and 9 months ended September 30, 2018 compared to $1.5 and $5.1 million for the first 3 and 9 months ended September 30, 2017. The $1.9 million increase was driven primarily to accelerate the operations related with the execution of the different clinical trials.

General and administrative expenses were $0.8 and $2.5 million for the first 3 and 9 months ended September 30, 2018, compared to $1.0 and $3.3 million for the first 3 and 9 months ended September 30, 2017

Net loss of $1.0 and $2.7 million for the first 3 and 9 months ended September 30, 2018 represents a decrease of 19% and 29% compared to a net loss of $1.2 and $3.8 million for the first 3 and 9 months ended September 30, 2017.

Negative Net Result of $0.5 million (-$0.01 per share) for the 9 months ended September 30, 2018 as a consequence of $3.1 million non-recurrent R&D tax deductions, compared to a negative net result of $4.6 million for the 9 months ended September 30, 2017 (-$0.13 per share).

Cash, cash equivalents and marketable securities totaled $26.2 million as of September 30, 2018, compared to $40.0 million as of September 30, 2017.

In October 30th the company has announced a Private Placement with US and European Investors and issued 4,961,833 new common shares, at a price of EUR 2.62 per share, representing a 12% discount on the closing price of the last three trading days. This represents gross proceeds of EUR 13 Million (circa $14,8 Million at the exchange rate of that day).

        
  ORYZON GENOMICS SA 
  BALANCE SHEET DATA (UNAUDITED) 
  (Amounts in thousands US $) 
        
   September 30th, 2018 September 30th, 2017  
        
  Cash and cash equivalents26,048 39,841  
  Marketable securities164 200  
  Total Assets65,148 69,741  
        
  Deferred revenue0 0  
  Total Stockholders' equity39,314 42,049  
        

 

       
 ORYZON GENOMICS SA
 STATEMENTS OF OPERATIONS (UNAUDITED)
 (US $, amounts in thousands except per share data)
        
   Three Months Ended
September 30
 Nine Months Ended
September 30
    
   20182017 20182017
        
 Collaboration Revenue00 020
        
 Operating expenses:     
 Research and Development1,9421,532 6,2335,130
 General and administrative8161,030 2,4813,263
        
 Total operating expenses2,7582,561 8,7148,393
        
 Loss from Operations-2,758-2,561 -8,714-8,373
        
 Other income, net1,7761,353 6,0324,618
        
 Net Loss -982-1,208 -2,682-3,755
        
 Net Financial & Tax-153-169 2,193-844
 0      
 Net Result-1,135-1,376 -489-4,599
   
     
 Loss / profit per share allocable to common stockholders:   
 Basic -0.03-0.04 -0.01-0.15
 Diluted -0.03-0.04 -0.01-0.15
        
 Weighted average Shares outstanding    
 Basic 33,492,80433,490,971 33,492,80431,176,052
 Diluted 33,492,80433,490,971 33,492,80431,176,052
     

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:Oryzon:
The Trout GroupATREVIAEmili Torrell
Thomas HoffmannPatricia CoboBD Director
+1 646 378 2932+34 91 564 07 25+34 93 515 13 13
thoffmann@troutgroup.compcobo@atrevia.com etorrell@oryzon.com