MIRAGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
•Completed enrollment of 37 patients in the Phase 2 SOLAR trial of cobomarsen in CTCL; expects to report topline data in Q3 2020
•Completed initial planned enrollment of the Phase 1 trial of cobomarsen in ATLL patients; reported additional data in January 2020; expects to meet with the FDA in Q3 2020 to explore a potential expedited development path
•Entered into a $20.0 million stock purchase agreement in December 2019; $5.1 million funded to date
•Closed $15.0 million equity offering in February 2020 extending cash runway into Q3 2021
•Reported $26.8 million in cash, cash equivalents, and short-term investments as of December 31, 2019
•Management to host conference call today at 4:30 p.m. ET
BOULDER, CO, March 11, 2020 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), today reported operating highlights and financial results for the quarter and full-year ended December 31, 2019 and provided an outlook for 2020.
“In 2019, we announced a series of changes intended to streamline our focus and operations. As a result, we enter 2020 with the opportunity to deliver several important milestones. We started the year by announcing positive new data for cobomarsen in ATLL patients in January and completed a $15.0 million equity financing in February which we believe extends our cash runway into the third quarter of 2021,” stated miRagen President and Chief Executive Officer, William S. Marshall, Ph.D.
“In the next few quarters, we look forward to meeting with FDA to discuss a potentially expedited development path for cobomarsen in ATLL, reporting topline data from the Phase 2 cobomarsen SOLAR trial in CTCL, and reporting additional preclinical data for MRG-229, our idiopathic pulmonary fibrosis (IPF) therapy product candidate. We believe this program provides us an exciting opportunity to deliver a potentially differentiated approach for the treatment of patients with IPF.”
Summary of Program Highlights
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).
•Cutaneous T-Cell Lymphoma: In December 2019, the Company announced plans to stop the enrollment of new patients in the SOLAR trial and conduct an analysis of topline clinical response. This analysis will provide controlled data to assess the benefit of cobomarsen based on disease response in the skin in comparison to vorinostat. A total of 37 patients have been enrolled and will continue to be evaluated for safety and clinical response in the coming months. miRagen plans to assess the rate of an objective response in the skin, that is durable for four months, defined as 50% or greater improvement in the severity of a patient’s skin disease over the entire body (mSWAT). This change from assessing overall response to skin response was driven by the fact that patients allowed into the study only have skin disease and are verified not to have blood, nodes, or visceral involvement at study entry. Improvements in skin disease are thus intended to reflect efficacy of the drug whereas progression in skin disease reflect lack of efficacy. Follow up analysis for blood, nodes or visceral disease may be conducted based on the results obtained using mSWAT. The Company believes that obtaining controlled clinical data from this cohort of patients may allow for a better assessment of the clinical potential of cobomarsen as compared to data from its Phase 1 trial. The Company intends for this controlled clinical data to form the basis of determining what additional clinical investigation of cobomarsen in CTCL is warranted, if any, and what would be required to potentially obtain regulatory approval. Topline data from this amended trial is expected to be announced in the third quarter of 2020.
•Adult T-Cell Leukemia/Lymphoma: In January 2020, the Company announced positive data for cobomarsen in ATLL patients with residual disease from this first-in-human Phase 1 clinical trial. In this trial, cobomarsen was observed to improve disease stabilization and reduce cellular proliferation and activation biomarker expression
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, March 11, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.