MIRAGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
•New ATLL data presented in the first quarter; Company plans to request a meeting with the FDA on a regulatory pathway for cobomarsen in ATLL during Q2 2020
•Additional NIH grant funding released in support of MRG-229 for IPF; preclinical studies progressing as planned with additional data expected to be released Q2 2020
•The SOLAR trial has been impacted by the COVID-19 pandemic; while most clinical sites have remained active, patient monitoring and dosing has been suspended at some sites
•Closed $15.0 million equity offering in February 2020
•Reported $36.1 million in cash and cash equivalents as of March 31, 2020; anticipate cash runway into Q3 2021
BOULDER, CO, May 7, 2020 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), today provided operational highlights and financial results for the first quarter ended March 31, 2020.
“We entered 2020 with streamlined operations and a team focused on delivering several important milestones. Prior to escalation of the COVID-19 pandemic, we reported positive new data for cobomarsen in ATLL patients in January and completed an equity offering in February to extend our runway. This quarter, we plan to report additional preclinical data for MRG-229, our idiopathic pulmonary fibrosis (IPF) therapy product candidate and request a meeting with the FDA to discuss a potential expedited development path for cobomarsen in ATLL,” stated miRagen President and Chief Executive Officer, William S. Marshall, Ph.D.
“The COVID-19 pandemic has affected some of the clinical sites at which the SOLAR trial is being conducted. In some cases, this has impacted our ability to dose or monitor patients because of site restrictions. We continue to actively monitor the situation, but until there is greater clarity on when normal activities at these sites will resume, we can’t confidently predict when topline data from the clinical trial will be available.”
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).
•Cutaneous T-Cell Lymphoma (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. While most clinical sites in the SOLAR trial remain active and over half of the patients had been on the trial for a sufficient period of time to provide topline data prior to the escalation of the COVID-19 pandemic, other patients have missed, or are at risk for missing, doses or in-person site visits for the collection of primary endpoint patient data. The Company has implemented home infusion services for this trial, as needed, and activated these services for those patients who could not receive the infusions at their clinical site. This is intended to mitigate some of the impact of the COVID-19 pandemic on the SOLAR trial. However, the collection of primary endpoint patient data requires in-person visits at clinical trial sites, which may require patients to be on the trial longer.
The Company is actively monitoring the effects of the COVID-19 pandemic on the SOLAR trial but cannot predict at this time when it will be able to collect uninterrupted endpoint data, with consistent dosing, in all remaining patients in the SOLAR trial. Accordingly, the Company no longer expects to report topline data from the SOLAR trial 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 prolong disease stabilization and median survival time in aggressive ATLL patients with persistent
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Thursday, May 7, 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.