MIRAGEN REPORTS THIRD QUARTER 2019 RESULTS AND PROVIDES CORPORATE UPDATE
•Announced positive data from two Phase 1 clinical trials of MRG-110
•Remain on track to announce interim top-line data from its Phase 2 clinical trial of remlarsen in keloids by year end
•Implemented restructuring to focus resources primarily on the development of cobomarsen and microRNA-29 mimics, including remlarsen
•Reported $33.8 million in cash, cash equivalents, and short-term investments as of September 30, 2019
•Management to host conference call today at 4:30 p.m. ET
BOULDER, CO, November 7, 2019 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company developing proprietary RNA-targeted therapies with a specific focus on microRNAs, today reported financial results for the third quarter ended September 30, 2019 and provided a corporate update.
“The miRagen team continues to generate clinical data essential to advancing our portfolio of microRNA targeting therapies being developed to address a number of complex diseases. We believe that this remains an exciting and underappreciated field of therapeutic development, and that our product candidates have the potential to become promising therapies for patients in need,” stated William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics.
“We recently released data from two Phase 1 clinical trials in which MRG-110, one of our three clinical stage product candidates, was observed to positively impact tissue repair and new blood vessel growth in humans. We believe the clinical and preclinical data we have accumulated for MRG-110 supports advancing this product candidate into additional clinical trials for multiple indications. We believe this new data and recent events provide an opportunity for the company to potentially collaborate with a partner to advance this Phase 2 ready asset as a potential treatment for patients who may benefit from increased vascular flow and accelerated healing,” concluded Dr. Marshall.
Cobomarsen is currently being evaluated in three clinical trials for multiple indications. The company’s primary clinical trial of cobomarsen is its global Phase 2 SOLAR trial, in which cobomarsen is being evaluated in patients with mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma (CTCL). To date, the study has opened approximately 70% of the total sites currently planned. miRagen now expects to report primary endpoint data from SOLAR in the second half of 2021. The company’s decision to update its guidance today is based on longer than anticipated time to activate the number of sites to support its previous patient enrollment projections resulting in slower than anticipated patient enrollment.
The SOLAR trial is supported, in part, by a collaboration with the Leukemia & Lymphoma Society ® (LLS) and its affiliate. LLS and its affiliate have agreed to provide up to $5.0 million through the purchase of miRagen common stock to help support the SOLAR trial. In October 2019, the company achieved one of the enrollment milestones and, as a result, the LLS affiliate invested an additional $0.5 million through the purchase of miRagen common stock.
Cobomarsen is also being evaluated in a Phase 1 clinical trial in three potential expansion indications where the disease process appears to be correlated with an increase in miR-155 levels, the target of cobomarsen. The trial has initially focused on treating patients with adult T-cell leukemia/lymphoma (ATLL), a rare and highly morbid disease.
Remlarsen and Other Related Product Candidates
Remlarsen is currently being evaluated in a Phase 2 clinical trial assessing its safety, tolerability, and activity in the potential prevention or reduction of keloid formation in subjects with a history of keloid scars, a form of pathological scarring. miRagen expects to report interim Phase 2 data from this clinical trial by the end of the year.
Based on preclinical data together with safety data from its Phase 1 clinical trial, the company believes that remlarsen may also be a product candidate in ophthalmic indications where fibrosis has been implicated. miRagen has also discovered and
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Thursday, November 7, 2019 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.