SOURCE: Oryzon Genomics

May 09, 2017 12:59 ET

ORYZON Reports Financial Results and Corporate Update for the 1st Quarter, 2017

BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - May 09, 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 quarter of 2017 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 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. Under the terms of the License Agreement, this clinical trial and all subsequent trials will be funded entirely by Roche. This trial is now following its normal course.

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 the experimental drug ORY-2001 were presented at the 13th International Conference on Alzheimer's and Parkinson's Diseases, which took place from 29 March to 2 April in Vienna. The safety data obtained in 80 volunteers have been positive and the pharmacological data obtained allows to define the doses to be used in the next Clinical Phases II with patients.

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, 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 Quarter Highlights

Financial Update: First Quarter 2017 Financial Results

Collaboration revenue was $0.02 million for the last 3 months ended March 31, 2017 and $0.34 million for the last 3 months ended March 31, 2016. The 1st quarter 2017 revenues are the last accrual of the Roche license 2015 milestone.

Research and development (R&D) expenses established themselves at $1.6 million for the last 3 months ended March 31, 2017 compared to the $1.1 million for the last 3 months ended March 31, 2016. The $0.5 million increase was driven primarily by accelerated R&D efforts in the ORY-2001 program.

General and administrative expenses were $1.0 million for the last 3 months ended March 31, 2017 and $1.3 million for the last 3 months ended March 31, 2016. This decrease is primarily due to the fact that during the first quarter 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 last 3 months ended March 31, 2017 was -$1.4 million (-$0.05 per share) compared to a net loss of -$0.8 million for the last 3 months ended March 31, 2016 (-$0.03 per share).

Cash, cash equivalents and marketable securities totaled $29.8 million as of March 31, 2017, compared to $33.0 million as of March 31, 2016.

After the 1st quarter 2017 closing, the Company completed a capital increase of 5,693,565 new common shares, with gross proceeds of approximately EUR18.2 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 (UNAUDITED)
(Amounts in thousands US $)
       
   March 31st, 2017  March 31st, 2016
       
Cash and cash equivalents  22,612  27,038
Marketable securities  7,207  5,968
Total Assets  55,971  56,620
       
Deferred revenue  0  286
Total Stockholders' equity  22,983  31,723
     
     
       
ORYZON GENOMICS SA
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(US $, amounts in thousands except per share data)
       
   Three Months Ended March 31,
   2017  2016
       
Collaboration Revenue  18  343
       
Operating expenses:      
Research and Development  1,564  1,138
General and administrative  967  1,274
       
Total operating expenses  2,531  2,412
       
Loss from Operations  -2,513  -2,069
       
Other income, net  1,509  1,320
Net Loss  -1,004  -749
       
Net Financial & Tax  -374  -75
Net Result  -1,378  -824
       
       
       
Loss per share allocable to common stockholders:
Basic  -0.05  -0.03
Diluted  -0.05  -0.03
       
Weighted average Shares outstanding
Basic  27,728,838  27,478,932
Diluted  27,728,838  27,478,932
     

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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