SOURCE: Oryzon Genomics

Oryzon Genomics

October 24, 2016 13:12 ET

ORYZON Reports Financial Results and Corporate Update for the 3rd Quarter Ended September 30, 2016

BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - October 24, 2016) - 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 third quarter of 2016 and provided an update on the Company's recent developments.

"The third quarter has seen the continuation of the Analysis of the data from our Phase 2a extension cohort clinical trial with ORY-1001 in Acute Leukemia. A first set of clinical data will be presented at the ASH Conference this coming December in San Diego and during an Ancillary meeting in front of the investor community," said Carlos Buesa, Ph.D., president and CEO of Oryzon.

"We are also very excited about the progression of ORY-2001, currently in Phase 1 clinical trial in healthy volunteers. ORY-2001 is the first ever Histone Demethylase inhibitor being explored in CNS disorders. The SAD phase was concluded in a satisfactory manner and we are now progressing in the MAD phase. This program should be Phase II ready in the first half of next year."

"Additionally, ORY-2001 has shown strong and robust preclinical efficacy in animal experiments on the EAE Multiple Sclerosis model. This broadens the indication's potential for the Clinical Development Plan of our second epigenetic drug. We believe that this oral drug can make a difference in the treatment of Neurodegenerative and Neuroinflammatory diseases."

"The company has also nominated a third LSD1 inhibitor, ORY-3001, as preclinical candidate for the treatment of a non-oncological yet undisclosed orphan disease. This program should be IND ready in the first half of next year. This is a proof that our LSD1-Epigenetics platform is efficient to add on additional molecules for other unmet medical needs."

Third Quarter Highlights

  • In JULY 2016 Oryzon nominated ORY-3001, a specific LSD1 inhibitor, next drug candidate to enter preclinical development in non-oncological indications
  • In JULY 2016 Oryzon Initiated Multiple Ascending Dose Cohorts in ORY-2001 Phase 1 Clinical Trial
  • In AUGUST 2016 Oryzon reported Financial Results and Corporate Update for the 1st Half Ended June 30, 2016
  • In SEPTEMBER 2016 Oryzon presented at the 18th Annual Rodman & Renshaw Global Investment Conference and at BioPharm America 2016
  • In SEPTEMBER 2016 the company announced the closing of a second tranche of Debt Funding round of 5.3 Million Euros (5.9 Million USD). These proceeds come on top of the 10.5 Million Euros (11.6 Million USD) raised in May. In total, Oryzon have raised more than 32 Million Euros (35.5 Million USD) since July 2015.
  • In SEPTEMBER 2016 Oryzon presented ORY-2001 preclinical efficacy data in a Multiple Sclerosis animal model at ECTRIMS-2016 Annual Meeting
  • In SEPTEMBER 2016, Oryzon was selected as one of the Finalist for the 7th Annual Most Innovative EU Biotech SME Award

Financial Update: Third Quarter 2016 Financial Results

Collaboration revenue was $0.2 million and $0.8 million for the 3 and 9 months ended September 30, 2016, respectively, as compared to $0.8 million and $3.8 million for the 3 and 9 months ended September 30, 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 $1.5 million and $4.0 million for the 3 and 9 months ended September 30, 2016, respectively, as compared to $1.0 million and $3.4 million for the 3 and 9 months ended September 30, 2015 respectively. The $2.5 million increase was driven primarily by accelerated R&D efforts in ORY-2001, a highly selective dual LSD1-MAOB inhibitor.

General and administrative expenses were $1.4 million and $4.2 million for the 3 and 9 months ended September 30, 2016, respectively, as compared to $0.9 million and $3.2 million for the 3 and 9 months ended September 30, 2015 respectively. The increase was driven primarily by increased head-count and stock market, strategic and compliance related activities.

Net loss was -$1.5 million and -$4.4 million for the 3 and 9 months ended September 30, 2016 (-$0.05 per share) respectively, compared to a net loss of -$0.4 million and -$0.4 million the 3 and 9 months ended September 30, 2015 (-$0.02 per share) respectively.

Cash, cash equivalents and marketable securities were $32.1 million as of September 30, 2016, compared to $24.3 million as of December 31, 2015. Oryzon closed a second tranche of Debt Funding round of $5.9 Million.

 
ORYZON GENOMICS SA
BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands US $)
       
   September 30, 2016  December 31, 2015
       
Cash and cash equivalents  25,900  21,809
Marquetable securities  6,248  2,511
Total Assets  56,564  45,633
       
Deferred revenue  0  403
Total Stockholders' equity  26,774  30,912
     
   
   ORYZON GENOMICS SA
   STATEMENT OF OPERATIONS (UNAUDITED)
                    (Amounts in thousands US $ except per share data) 
     
   Three Months Ended September 30, Nine Months Ended September 30,
   2016  2015  2016  2015
             
Collaboration Revenue  252  843  785  3,848
             
Operating expenses:            
Research and Development  1,493  1,000  4,006  3,394
General and administrative  1,367  976  4,204  3,234
             
Total operating expensese  2,860  1,976  8,210  6,628
             
Loss from Operations  -2,608  -1,133  -7,425  -2,780
             
Other income, net  1,092  702  2,788  2,376
             
Net Loss  -1,516  -431  -4,637  -404
             
             
             
             
             
Loss per share allocable to common stockholders:            
Basic  -0.05  -0.02  -0.17  -0.02
Diluted  -0.05  -0.02  -0.17  -0.02
             
Weighted average Shares outstanding            
Basic  27,589  -  27,517  -
Diluted  27,589  -  27,517  -
         

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 out-license 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.

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