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ORY-1001 (RG6016) (Oryzon/Roche)

Products Next higher product group LSD1 inhibitor (Lysine Specific Demethylase-1 inhibitor)
Period Status 2014-04-07 development p2 existent
Organisations Organisation Roche (Group)
  Organisation 2 Oryzon Genomics S.A. (Madrid Stock Exchange: ORY)
  Group Oryzon Genomics (Group)
     

Oryzon Genomics S.A.. (7/20/17). "Press Release: Oryzon to Regain Rights to ORY-1001 (RG6016)". Barcelona & Cambridge, MA.

Oryzon Genomics (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced that yesterday evening Roche informed Oryzon that due to a portfolio prioritization, it has decided to discontinue its involvement in the clinical development of the investigational Lysine Specific Demethylase-1 (LSD1) inhibitor ORY-1001 (RG6016) for the treatment of patients with acute myeloid leukemia (AML) and solid tumors pursuant to the license agreement between Oryzon and Roche dated April 1st, 2014.

As a consequence of such decision, the rights that Oryzon had licensed to Roche with respect to ORY-1001 will revert to Oryzon when the termination of the license agreement becomes effective. Also pursuant to the terms of the license agreement, Roche is committed to finalize the ongoing Phase I in small cell lung cancer (SCLC) following the clinical development plan, which is expected to occur in the following months.

"We are obviously disappointed by this decision" said Carlos Buesa, Chief Executive Officer of Oryzon. "We have been informed that the decision was not data driven but a consequence of internal reprioritization of Roche’s pipeline. During the next weeks, Oryzon will focus its efforts to regain the control of the asset as soon as possible to ensure the continuation of the clinical development plan without interruptions. We are fully committed to develop ORY-1001, a first-in-class, best-in-class LSD1 inhibitor that we believe has a clear potential in a broad range of tumors”.

The terms of the license agreement with Roche can be found in the Company's S1 (Documento de Registro) filed at the CNMV and at https://www.oryzon.com/en/investors/share-information/share-issues

Web Conference Details The Company has scheduled two web conferences today July 20th to discuss this development, one at 10:00 am CET in Spanish, and another one at 8:30 am ET in English. Oryzon’s senior management team
will host the conference, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Spanish web conference:
Live access to the conference will be available via Oryzon’s website, www.oryzon.com, at the link https://meetings.webex.com/collabs/meetings/join?uuid=M35GNSH230ABX82D0MYSDT0N7D-28UJ, or dialing 900 937 920 (Spain, toll free), +34-917911283 (Spain), +1-631-267-4890 (USA) or 1-855-299-5224 (USA, toll free) indicating access code 232 342 882. To call from other countries, please check phone numbers at the following link https://meetings.webex.com/collabs/meetings/globalCallInNumbers?uuid=M35GNSH230ABX82D0MYSDT0N7D-28UJ. Questions for the Q&A session should be submitted via email to Q&A-es@oryzon.com during the web conference.

English web conference:
Live access to the conference will be available via Oryzon’s website, www.oryzon.com, at the link https://meetings.webex.com/collabs/meetings/join?uuid=M2B03E2BAQ7XR25KIBFHB6Z4MP-28UJ, or dialing 900 937 920 (Spain, toll free), +34-917911283 (Spain) or ), +1-631-267-4890 (USA) or 1-855-299-5224 (USA, toll free) indicating access code 231 419 426. To call from other countries, please check phone numbers at the following link https://meetings.webex.com/collabs/meetings/globalCallInNumbers?uuid=M35GNSH230ABX82D0MYSDT0N7D-28UJ. Questions for the Q&A session should be submitted via email to Q&A-en@oryzon.com during the web conference.

A recorded version of the web conferences will be made available via Oryzon’s website, www.oryzon.com.


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, 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 believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon 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, 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 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, 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 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 on the date hereof. Except as required by applicable law, Oryzon 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:
The Trout Group
Naomi Eichenbaum
+1 646 378 2932
NEichenbaum@troutgroup.com

Spain:
ATREVIA
Patricia Cobo/Luis Rejano
pcobo@atrevia.com
lrejano@atrevia.com
+34 91 564 07 25

The Company:
Emili Torrell
BD Director
+34 93 515 13 13
etorrell@oryzon.com

   
Record changed: 2023-07-10

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