SOURCE: Oryzon Genomics

Oryzon Genomics

July 28, 2017 13:49 ET

ORYZON Reports Financial Results and Corporate Update for the 1st Half Ended June 30, 2017

BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - July 28, 2017) - Oryzon Genomics (ISIN Code: ES0167733015) (MAD: 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 half of 2017 and provided an update on the Company's recent developments.

The company successfully completed the Phase I/IIA clinical trial of its epigenetic drug ORY-1001 in acute leukemia; data was presented at the ASH-2016 Conference in December in San Diego, providing a biological proof of concept and allowing the characterization of the first clinical responses. With the final analysis of the data, this study is now on regulatory closing, which the company expects to culminate in the near term. The data from this study together with data coming from joint research contributed to the decision by our licensee Roche to start a new Phase I clinical trial in small cell lung cancer patients. This trial enrolled its first patient earlier this year and it is now in the dose escalation phase. On July 19th, Roche notified Oryzon of its decision to discontinue its involvement in the clinical development of ORY-1001 due to a re-prioritization of its portfolio. Roche's decision was not related with the data obtained with the drug in the ongoing clinical trial in lung cancer but rather a business decision based on a re-prioritization of its pipeline and internal resources. Roche will complete the ongoing dose escalation phase and return the drug to Oryzon as well as all clinical, preclinical and scientific information obtained so far, at no cost to Oryzon. Oryzon has expressed its commitment to continue the clinical development of this drug. In accordance with the terms of the License Agreement, the final transfer of the asset and all information will not be delayed more than 6 months from the termination notice.

The Phase I clinical trial of ORY-2001, a dual inhibitor of LSD1 and MAOB, in healthy volunteers to assess its potential in Alzheimer's disease and Multiple Sclerosis has progressed satisfactorily. Preliminary clinical data on safety of ORY-2001 were presented at the 13th International Conference on Alzheimer's and Parkinson's Diseases, held from 29 March to 2 April in Vienna. The safety data obtained in 80 volunteers were positive and the pharmacological data obtained allowed to define the doses to be used in the next Clinical Phases II with patients. In order to gain more insight on the hematological effect, to make a robust PK-PD modeling and to determine the brain penetration of the drug, an amendment was filed at the Spanish Medicines Agency (AEMPS) to treat 3 cohorts of additional volunteers. These data will allow finalizing the Phase I study with 106 volunteers and their results will be presented in an upcoming specialized conference.

The company has continued its experimental work in preclinical models of Alzheimer's disease and other CNS indications and has done substantial advances in the characterization of the mechanism of action of ORY-2001 in the EAE Multiple Sclerosis model and also in models representing other CNS diseases. This broadens the therapeutic indication's potential for the Clinical Development Plan of this drug. The company will present these and other data in specialized conferences to be announced soon.

ORY-3001, the company's third LSD1 inhibitor, currently in preclinical development for the treatment of a non-oncological, yet undisclosed, orphan disease, continues its favorable progression through the regulatory toxicology package. This program should be IND/CTA ready in 2017.

First Half Year Highlights

  • In APRIL 2017 ORYZON presented data on the Phase I trial with ORY-2001 at the 13th International Conference on Alzheimer's and Parkinson's Diseases (ADPD).
  • In APRIL 2017 ORYZON announced a new grant from the Alzheimer's Drug Discovery Foundation (ADDF) to develop a companion marker for its ORY-2001 epigenetic drug.
  • In MAY 2017 ORYZON announced the appointment of a new Chief Medical Officer and expansion of its Medical Department
  • In JULY 2017 ORYZON announced it will regain rights to ORY-1001.

Financial Update: First Half 2017 Financial Results

Collaboration revenue was $0.00 and $0.02 million for the first 3 and 6 months ended June 30, 2017 and $0.20 and $0.53 million for the first 3 and 6 months ended June 30, 2016. The 1st half 2017 revenues are the last accrual of the Roche license 2015 milestone.

Research and development (R&D) expenses established themselves at $1.8 and $3.5 million for the first 3 and 6 months ended June 30, 2017 compared to the $1.4 and $2.5 million for the first 3 and 6 months ended June 30, 2016. The $1.0 million increase was driven primarily by accelerated R&D efforts in the ORY-2001 program.

General and administrative expenses were $1.1 and 2.2 million for the first 3 and 6 months ended June 30, 2017 and $1.6 and $2.8 million for the first 3 and 6 months ended June 30, 2016. This decrease is primarily due to the fact that during the first half of 2016 the company incurred in specific expenses related with the activities to list the company in the Spanish stock market.

Net loss for the first 3 and 6 months ended June 30, 2017 was $1.4 and $2.6 million (-$0.10 per share) compared to a net loss of $1.8 and $2.6 million for the 3 and 6 months ended, 2016 (-$0.11 per share).

Cash, cash equivalents and marketable securities totaled $42.8 million as of June 30, 2017, compared to $33.4 million as of June 30, 2016.

In April, 4th 2017, the Company completed a capital increase of 5,693,565 new common shares, with gross proceeds of approximately EUR18.2 million ($20,8 million). This represents the maximum capital increase the company could undertake under the current approved resolutions of its General Assembly. The shares were sold at a price of EUR3.20 per share. The majority of the funds were raised from international investors, reinforcing and diversifying the Company's shareholder base.

      
      
ORYZON GENOMICS SA
BALANCE SHEET DATA (AUDITED)
(Amounts in thousands US $)
      
  June 30th, 2017   June 30th, 2016
      
Cash and cash equivalents 41,493    27,149 
Marquetable securities 1,303    6,241 
Total Assets 70,932    56,568 
      
Deferred revenue   176 
Total Stockholders' equity 41,972    27,473 
            
ORYZON GENOMICS SA
STATEMENTS OF OPERATIONS (AUDITED)
(US $, amounts in thousands except per share data)
            
 
 
Three Months Ended June 30,  Six Months Ended June 30
  2017  2016  2017  2016
            
Collaboration Revenue 0  195  19  530
            
Operating expenses:           
Research and Development 1,809  1,390  3,478  2,499
General and administrative 1,127  1,580  2,159  2,823
            
Total operating expenses 2,935  2,970  5,637  5,322
            
Loss from Operations -2,935  -2,775  -5,618  -4,793
            
Other income, net 1,545  941  3,156  2,228
            
Net Loss -1,391  -1,834  -2,462  -2,565
            
Net Financial & Tax -254  -467  -653  -540
            
Net Result -1,644  -2,301  -3,115  -3,105
            
            
            
            
Loss per share allocable to common stockholders:         
Basic -0.10  -0.11      
Diluted -0.10  -0.11      
            
Weighted average Shares outstanding          
Basic 30,183,944
 27,480,943      
Diluted 30,183,944 27,480,943      

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 is currently covered by + 20 patent families and 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. Oryzon's strategy is to develop first in class compounds against novel epigenetic targets through Phase II clinical trials, at which point it is decided on a case-by-case basis to either keep the development in-house or to partner or outlicense the compound for late stage development and commercialization. The company has offices in Barcelona and Cambridge, Massachusetts. 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.

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