ORYZON Provides a Corporate Update in the Context of COVID-19
MADRID, Spain and CAMBRIDGE, Mass., April 17, 2020 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announces today that, since the emergence of the COVID-19 pandemic, the company has been implementing and executing contingency plans necessary to ensure the health and safety of its employees, partners and clinical trial participants. These plans have been formulated to enable business continuity, and allow the company to fulfill its responsibility to continue developing experimental drugs for serious illnesses with unmet medical needs.
Oryzon has implemented a set of measures aligned with these principles and has carefully followed the recommendations enacted by the authorities. Among them, it has implemented a comprehensive work-from-home policy. Those employees involved on critical research and development and laboratory activities follow reinforced measures for prevention and disinfection, including safety guidelines to reduce close interactions and limiting the number of people required on-site, and the implementation of flexible schedule of work- hours.
Oryzon has not canceled or postponed recruitment in ongoing clinical trials, but the operations of ongoing clinical trials have been adapted following the instructions of the regulatory agencies (FDA, EMA, AEMPS) in order to protect the health of participating patients, their families and healthcare professionals, and to preserve the integrity of the trial data as much as possible. Given the advanced age and vulnerability of patients participating in ALICE (elderly leukemia patients who are not eligible for conventional chemotherapy) and in REIMAGINE-AD, ETHERAL-EU and ETHERAL-US (elderly Alzheimer's patients), the company has reduced the requirement for hospital visits by these patients, being replaced when possible by remote monitoring. It is foreseeable that, in some cases, there is a risk that certain data may be incomplete due to visits or evaluations not carried out. The recruitment in CLEPSIDRA trial (Phase IIa clinical trial investigating iadademstat in small cell lung cancer patients) has been finalized.
Also, given the current general situation of lock-down, Oryzon has decided to postpone the activation of its Phase IIb trial in agitation-aggression in patients with borderline-personality disorder (PORTICO trial) for a few months. The company is continually evaluating the situation and will report promptly when additional information becomes available.
The company believes it has sufficient manufactured drug material to supply its ongoing clinical studies. Preparations for new clinical trials in CNS and cancer continue.
Finally, the Company has also implemented the necessary actions in order to guarantee the fulfillment of its normal financial obligations. Cash, cash equivalents and marketable securities totaled $39.6 million as of December 31, 2019.
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds, vafidemstat and iadademstat, in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurological diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com
This communication contains, or may contain, 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 Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. 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 or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.
|IR & Media, US & Europe:||Spain:||Oryzon:|
|LifeSci Advisors LLC||ATREVIA||Emili Torrell|
|Hans Herklots||Patricia Cobo/Carlos C. Ungría||BD Director|
|+41 79 598 7149||+34 91 564 07 25||+34 93 515 13 13|
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