MIRAGEN REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS AND
PROVIDES CORPORATE UPDATES
•Recently completed acquisition of Viridian Therapeutics, including an anti-IGF-1R monoclonal antibody, VRDN-001, for the potential treatment of thyroid eye disease (TED)
•Private placement financing proceeds of approximately $91 million positions miRagen to potentially advance multiple compounds through Phase 2 proof of concept studies in TED and expand its orphan disease pipeline
•After completion of the acquisition of Viridian Therapeutics and the private placement financing, miRagen has cash on hand of approximately $144 million and estimated cash runway through 2023
•Announces 1-for-15 reverse stock split to be effective as of November 12, 2020 and trading of the common stock will begin on a split-adjusted basis when markets open on November 13, 2020
BOULDER, CO, November 10, 2020 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a biotechnology company advancing new treatments for patients with diseases that are underserved by current therapies, today announced financial results for the third quarter ended September 30, 2020 and provided corporate updates.
“With our recent acquisition of Viridian Therapeutics, concurrent financing and senior leadership additions, we believe miRagen is well positioned to advance the development of new treatments designed for patients with diseases that are underserved by current therapies, beginning with thyroid eye disease, or TED,” said Lee Rauch, Chief Executive Officer of miRagen. “We believe that VRDN-001, an insulin-like growth factor-1 receptor monoclonal antibody, has the potential to become a meaningful treatment option for patients suffering from TED. We plan to initiate a Phase 2 clinical trial of VRDN-001 in 2021.”
Recent Program and Corporate Highlights
Announced Completed Acquisition of Viridian Therapeutics
In October 2020, miRagen announced the completed acquisition of Viridian Therapeutics, Inc., a privately held biotechnology company developing therapies for TED, a debilitating condition that can cause bulging eyes, or proptosis, as well as double vision and potential blindness.
Following the acquisition, miRagen’s most advanced program is VRDN-001, a monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF1R) and a potential treatment for patients with TED. Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021. This planned trial will be informed by data from previous U.S. and EU studies in which more than 100 oncology patients were administered the antibody under the name AVE-1642. The pharmacokinetic, pharmacodynamic, and safety and tolerability data from these previous studies will inform miRagen’s trial designs in TED. miRagen holds exclusive worldwide rights to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals, including the treatment of TED. Viridian Therapeutics had previously licensed VRDN-001 from ImmunoGen, Inc.
In parallel with the development of VRDN-001, miRagen is advancing VRDN-002 with the goal of developing a convenient, at-home subcutaneous injection product. VRDN-002 seeks to improve on first-generation IGF-1R-targeted antibodies by incorporating half-life extension technology to reduce the dose required to provide efficacy in TED. miRagen expects to file an investigational new drug application for VRDN-002 by the end of 2021.
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Tuesday, November 10, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.