miRagen Therapeutics, Inc. Announces Acquisition of Viridian Therapeutics, Inc. - Seite 2

miRagen’s lead candidate, VRDN-001 will be studied as a potential treatment for patients with TED. More than 100 oncology patients have previously been treated with the antibody in US and EU studies, under the name AVE-1642, enabling some understanding of its pharmacokinetic and pharmacodynamic profile, as well as its safety and tolerability. Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021.

Worldwide rights to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals, including the treatment of TED, were exclusively licensed by Viridian from ImmunoGen, Inc. Under the terms of the agreement, ImmunoGen received an upfront payment, and is eligible for additional developmental milestones and mid-single-digit royalty payments.

In parallel with VRDN-001 development, Viridian initiated the VRDN-002 program, which seeks to improve IGF-1R-targeted antibodies by incorporating half-life extension technology to reduce the dose required to achieve full efficacy in TED patients and enhance solubility to achieve the lowest possible injection volume. This program is advancing rapidly and miRagen expects to file an Investigational New Drug application for VRDN-002 in 2021.

Contingent Value Right

In connection with the transactions announced today, a non-transferrable contingent value right (“CVR”) is expected to be distributed to holders of miRagen common stock within the next 30 days. Holders of the CVR will be entitled to receive certain payments from proceeds received by miRagen, if any, related to the disposition of its legacy microRNA-based assets for a period of five years following the closing of the transaction. miRagen is actively conducting broad-based outreach to find a partner or to spin-out new enterprises for its legacy microRNA-based programs.

Management and Organization

The current miRagen management team, including Lee Rauch, Chief Executive Officer, Jason A. Leverone, Chief Financial Officer, and Diana Escolar, MD, FFAN, Chief Medical Officer, will be expanded with the appointment of Jonathan Violin, PhD, CEO of Viridian, to President and Chief Operating Officer of miRagen, and Vahe Bedian, PhD, Chief Scientific Officer of Viridian, to CSO of miRagen.

In conjunction with the transaction, miRagen Board members will include Jeffrey Hatfield, Chairman of the Board of Directors, miRagen, Peter Harwin, Managing Member, Fairmount Funds, Tomas Kiselak, Managing Member, Fairmount Funds, and current miRagen Board members Arlene M. Morris, CEO, Willow Advisors, LLC, Lee Rauch, CEO, miRagen, and Joe Turner, Board of Directors Audit Chair, miRagen.