MIRAGEN REPORTS SECOND QUARTER 2019 RESULTS; REGAINS GLOBAL RIGHTS TO MRG-110 AND ANNOUNCES CORPORATE RESTRUCTURING
•miRagen to regain global rights to MRG-110 after Servier provides notice of portfolio realignment; expects to announce Phase 1 data during the second half of 2019
•Company anticipates reporting primary endpoint data from the SOLAR clinical trial in the first half of 2021
•Restructuring to focus resources primarily on the clinical development of cobomarsen and microRNA-29 mimics, including remlarsen
•Reported $43.9 million in cash, cash equivalents, and short-term investments as of June 30, 2019
•Management to host conference call today at 4:30 p.m. ET
BOULDER, CO, August 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 second quarter ended June 30, 2019 and provided a corporate update.
“The data generated in our Phase 1 trials of MRG-110 demonstrated good safety and tolerability as well as preliminary proof of mechanism of action in humans. We appreciate the collaborative support we’ve received from Servier in the MRG-110 program up to this point and understand that due to a strategic evaluation of their pipeline, they have decided to discontinue development of MRG-110. While we are currently evaluating the impact on the MRG-110 development timeline, we are pleased to have regained global rights to this Phase 2-ready asset, and will seek a new development partner or potentially pursue other development strategies for this program,” stated William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics.
“Looking ahead, we will continue to focus on the advancement of our lead programs for cobomarsen and remlarsen, both of which have ongoing Phase 2 studies. Under this strategy, we are implementing a cost reduction plan that will concentrate our resources on the advancement of these lead programs, as well as activities in support of our licensing efforts. Implementing this cost reduction program was a difficult decision to make, but we believe that it is important to extend our cash runway and deliver on important milestones.”
“We have a number of clinical data announcements and updates expected to occur in the second half of 2019 that are expected to further support future development decisions and the prioritization of our clinical programs. In the second half of this year, miRagen expects to (i) report the results of the Phase 1 clinical trials for MRG-110 that assessed safety, tolerability and proof of mechanism in humans; (ii) report interim data from the Phase 2 clinical trial of remlarsen in the prevention or reduction of keloid scarring; and (iii) provide updates on the SOLAR trial of cobomarsen in CTCL,” concluded Dr. Marshall.
MRG-110 and miRagen’s Collaboration Agreement with Servier
miRagen announced today that it received notice of Servier’s intention to end the collaboration, which included development of MRG-110. MRG-110 is being evaluated in two Phase 1 trials, which are expected to support future clinical trials for the treatment of heart failure and other conditions where patients may benefit from increased vascular flow and accelerated healing, such as complicated lacerations in high risk patients. Based on a strategic review of its portfolio, Servier decided not to proceed with the collaboration. As a result, miRagen will regain rights to MRG-110 in all indications and all territories globally including rights in the US and Japan which it already controlled under the collaboration and licensing agreement with Servier. Under the terms of the agreement, Servier will continue to support certain costs of development until February 2020.
The Company expects to report Phase 1 clinical data of MRG-110 at an upcoming scientific conference in the fourth quarter of 2019. In these trials, MRG-110 was generally safe and well tolerated, and the Company believes the program is ready to advance to Phase 2 clinical development. With the corporate restructuring announced today, miRagen is currently evaluating development strategies for MRG-110, which may include seeking a new development and licensing partner.
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, August 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.