MIRAGEN REPORTS SECOND QUARTER 2020 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES
•Progress on next generation microRNA-29 mimic for use in pulmonary fibrosis (MRG-229) includes new preclinical data; additional NIH grant funding triggered
•Exploratory preclinical safety and pharmacokinetic data for MRG-229 expected before year end
•Plan to receive guidance from the FDA on proposed regulatory pathway for cobomarsen in ATLL before year end
•A majority of patients in the Phase 2 SOLAR trial of cobomarsen in CTCL have continued to receive uninterrupted treatment and are being evaluated for clinical response
•Reported $30.6 million in cash and cash equivalents as of June 30, 2020; anticipate cash runway into Q3 2021
BOULDER, CO, August 5, 2020 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary RNA-targeted therapies with a specific focus on microRNAs, today reported financial results for the second quarter ended June 30, 2020 and provided business updates.
“The miRagen team continues to execute on our strategy across multiple product opportunities, by pursuing guidance from the FDA on a development pathway for cobomarsen in ATLL, delivering preclinical data for MRG-229 in pulmonary fibrosis models that triggered NIH funding to support large animal safety and pharmacokinetic studies, and working closely with our clinical centers to ensure our ability to deliver topline data from the planned interim analysis in the Phase 2 SOLAR trial,” said William S. Marshall, Ph.D., miRagen’s President and Chief Executive Officer.
“We are encouraged by the preclinical and clinical safety and efficacy data we have generated across all of our programs and energized about the potential of microRNA-based therapies to bring benefit to patients in need.”
Summary of Program Highlights this Quarter
Cobomarsen: Cobomarsen is currently being evaluated for the potential treatment of patients with miR-155 elevated hematological malignancies, including Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia/Lymphoma (ATLL).
•CTCL: As a result of the COVID-19 pandemic, the Company has seen an impact on clinical activities at some sites where the SOLAR trial is being conducted. However, with a majority of patients in the SOLAR trial continue to receive uninterrupted treatment and evaluation for clinical response, the impact has been limited to a small number of patients. As of July 17, 2020, 34 of the 37 CTCL patients are being followed for a response, and 32 have continued to receive uninterrupted treatment.
•ATLL: Based on the clinical data released earlier this year, during the second quarter of 2020, the Company requested a meeting with the FDA to discuss the development path for cobomarsen in ATLL and plans to meet with the FDA and receive guidance on the Company’s proposed clinical path in this indication before the end of 2020.
MRG-229: MRG-229 is a miR-29 mimic, or replacement for miR-29, a microRNA that is found at abnormally low levels in a number of pathologic fibrotic conditions.
•Idiopathic Pulmonary Fibrosis (IPF): In June 2020, the Company hosted a key opinion leader (KOL) webcast to discuss the current and increasing unmet medical need in treating patients with IPF and reported additional preclinical rodent safety and in vitro human efficacy data for MRG-229. In summary, the latest preclinical observations were:
◦Next-generation targeted miR-29 mimics demonstrated down-regulation of targeted genetic pathways and anti-fibrotic effects including decreased collagen secretion in diseased lung fibroblasts in vitro, highlighting functional activity in addition to molecular readouts.
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, August 5, 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.