SOURCE: Oryzon Genomics

Oryzon Genomics

February 24, 2017 13:40 ET

ORYZON Reports Financial Results and Corporate Update for the Fourth Quarter and Year Ended December 31, 2016

BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - February 24, 2017) - Oryzon Genomics (MAD: ORY) (ISIN Code: ES0167733015), 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 2016 and provided an update on the Company's recent developments.

The company successfully completed the Phase I/IIA clinical trial in acute leukemia of its epigenetic drug ORY-1001; data was presented at the ASH-2016 Conference in December in San Diego, providing a demonstration of biological proof of concept and allowing the characterization of the first clinical responses. These and other data contributed to the decision by our licensee Roche to start a new Phase I clinical trial in small cell lung cancer patients. Under the terms of the License Agreement, this clinical trial and all subsequent trials will be funded entirely by Roche.

ORY-2001 has continued its satisfactory progression in the MAD phase of the Phase I clinical trial in healthy volunteers. ORY-2001 is the first ever Histone Demethylase inhibitor being explored in CNS disorders, with a particular emphasis in Alzheimer's disease and Multiple Sclerosis. This program should be Phase II ready in the first half of 2017.

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. This broadens the therapeutic indication's potential for the Clinical Development Plan of this drug.

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

Fourth Quarter Highlights

Financial Update: Fourth Quarter 2016 Financial Results

Collaboration revenue was $0.03 million and $0.8 million for the last 3 and 12 months ended December 31, 2016, respectively, as compared to $0.9 million and $4.6 million for the last 3 and 12 months ended December 31, 2015 respectively. The period-over-period decreases reflect decreased recognition of deferred revenue from upfront payments and research and development revenue related to the Company's collaboration with Roche.

Research and development (R&D) expenses were $1.7million and $5.5 million for the last 3 and 12 months ended December 31, 2016, respectively, as compared to $0.7 million and $4.1 million for the last 3 and 12 months ended December 31, 2015 respectively. The $1.0 million increase was driven primarily by accelerated R&D efforts in the ORY-2001 program.

General and administrative expenses were $1.0 million and $5.0 million for the last 3 and 12 months ended December 31, 2016, respectively, as compared to $1.5 million and $4.6 million for the last 3 and 12 months ended December 31, 2015 respectively. This decrease is primarily due to the fact that during the fourth quarter of 2015 the company incurred in specific expenses related with the activities to list the company in the Spanish Stock market.

Net loss was -$1.4 million and -$5.7 million for the last 3 and 12 months ended December 31, 2016 (-$0.20 and -$0.21 per share) respectively, compared to a net loss of -$0.7 million and -$1.1 million the last 3 and 12 months ended December 31, 2015 (-$0.03 and -$0.04 per share) respectively.

Cash, cash equivalents and marketable securities were $28.7 million as of December 31, 2016, compared to $23.7 million as of December 31, 2015. Oryzon closed a tranche of Debt Funding round in 2016 of $16.6 million.

 
ORYZON GENOMICS SA
BALANCE SHEET DATA (AUDITED)
(US $, amounts in thousands)
     
  December 31, 2016 December 31, 2015
     
Cash and cash equivalents 23,220 21,270
Marquetable securities 5,525 2,449
Total Assets 52,435 44,505
     
Deferred revenue 0 393
Total Stockholders' equity   23,958  30,148
     
       
  ORYZON GENOMICS SA
  CONSOLIDATED STATEMENTS OF OPERATIONS (AUDITED)
  (US $, amounts in thousands except per share data)
         
   Three Months Ended December 31, 
Twelve Months Ended December 31,  
  2016 2015 2016 2015
         
Collaboration Revenue 34 894 775 4,647
         
Operating expenses:        
Research and Development 1,709 742 5,492 4,053
General and administrative 1,040 1,470 5,011 4,624
         
Total operating expenses 2,749 2,212 10,503 8,676
         
Loss from Operations -2,716 -1,318 -9,728 -4,029
         
Other income, net 1,496 736 4,903 3,774
         
Net Loss -1,220 -582 -4,825 -255
         
Net Financial & Tax -143 -108 -918 -829
         
Net Result -1,363 -690 -5,743 -1,084
         
         
         
Loss per share allocable to common stockholders:        
Basic -0.20 -0.03 -0.21 -0.04
Diluted -0.20 -0.03 -0.21 -0.04
         
Weighted average Shares outstanding        
Basic 27,722,764 27,167,422 27,568,824 24,728,882
Diluted 27,722,764 27,167,422 27,568,824 24,728,882
         

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 and a clinical asset already partnered with Roche. 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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