“We are very pleased that the FDA granted Orphan Drug Designation to GBC0905 as an accomplishment for our team and an important milestone in our journey toward bringing our lead product candidate to the clinic. We anticipate GBC0905 to be the first targeted therapy for patients suffering from FSHD, a relentless and debilitating disease,” said Dr. Uli Schmidt, President of Genea Biocells. “The Orphan Drug Designation also validates our skeletal muscle technology which is a highly useful platform for modeling any number of other myogenic indications as we expand our pipeline.”

Genea Biocells’ lead scientist for the FSHD program, Amanda Rickard, added, “Our targeted therapeutic candidate GBC0905 potently suppresses DUX4 function, prevents the activation of DUX4 target genes, and protects affected skeletal muscle cells in a dose-dependent fashion and, importantly, without affecting normal myogenesis. Aberrant DUX4 expression is the underlying cause of the disease and results in muscle fiber death. The FSHD field generally believes that blocking DUX4 will be curative. We are looking forward to thorough and expeditious development of this much-needed therapy.”

Currently, Genea Biocells is seeking capital to advance GBC0905 to clinical trials, complete preclinical work on their Spinal Muscular Atrophy (SMA) program, and expand the pipeline to other orphan muscle diseases. Under the U.S. Orphan Drug Act, the FDA grants Orphan Drug Designation status to novel therapeutics for rare diseases, defined as those affecting fewer than 200,000 people in the U.S. All of Genea Biocells’ product candidates are ultimately expected to benefit from Orphan Drug Designation. Advantages include tax credits for qualified clinical trials costs and seven years of market exclusivity upon regulatory product approval.

About FSHD

Facioscapulohumeral Dystrophy (FSHD) is an inheritable muscle disease affecting up to 1:8,000 people. There is no cure or treatment strategy for patients with FSHD. This debilitating disease slowly consumes skeletal muscle, robbing people of the active, healthy, and independent years of their lives. It is caused by the sporadic de-repression of a toxic gene, DUX4, in the muscles of FSHD patients.

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To the extent statements contained in this news release are not descriptions of historical facts regarding Genea Biocells US Inc. they should be considered ''forward-looking statements,'' as described in the private securities litigation reform act of 1995, that reflect management's current beliefs and expectations. You can identify forward-looking statements by words such as ''anticipate,'' ''believe,'' ''could,'' ''estimate,'' ''expect,'' ''forecast,'' ''goal,'' ''hope,'' ''hypothesis,'' ''intend,'' ''may,'' ''plan,'' ''potential,'' ''predict,'' ''project,'' ''should,'' ''strategy,'' ''will,'' ''would,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in these presentations include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) our ability to meet our milestones; and (vi) our expectations regarding our ability to obtain and maintain intellectual property protection. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to update any forward-looking statements. Genea Biocells' investigational drug products have not been approved or cleared by the FDA.

Contacts

Genea Biocells US Inc.
Debra Bressaw, 858 281 4840