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BOULDER, Colo., May 09, 2018 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today reported first quarter 2018 financial results and provided a corporate update.
“With three product candidates now in clinical development and additional preclinical programs targeting multiple indications, we are continuing to advance, de-risk and build confidence in our pipeline of potential microRNA targeted therapies,” said William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics. “Cobomarsen and MRG-201 remain on track to advance into Phase 2 clinical trials later this year, and we were pleased to have recently initiated two Phase 1 clinical trials for MRG-110 in collaboration with our partner, Servier. We also continued to expand the potential of our innovative microRNA technologies by unveiling a new preclinical program evaluating microRNA mimics of the microRNA-183/96/182 cluster involved in retinal degeneration.”
Marshall continued, “We are encouraged by the advancement of our pipeline of microRNA therapeutic candidates and excited about the opportunities that our microRNA focused discovery and development platform could provide as our clinical programs continue to show promising efficacy and safety profiles.”
Recent Achievements and Anticipated Progress
First Quarter 2018 Financial Results
Cash and Cash Equivalents
Conference Call Information
miRagen will host a conference call today at 4:30 p.m. ET to discuss its financial results for the first quarter 2018. Participants may access the call by dialing (888) 394-8218 in the U.S. or (323) 701-0225 outside the U.S. and providing the conference ID number 8152157. The call will also be webcast and can be accessed from the Investors and Media section of miRagen’s website at www.miragen.com. A replay of this conference call will be available on miRagen’s website approximately one hour after the event.
About miRagen Therapeutics, Inc.
miRagen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen has three clinical stage product candidates, cobomarsen (MRG-106), MRG-201, and MRG-110. miRagen’s clinical product candidate for the treatment of certain cancers, cobomarsen, is an inhibitor of microRNA-155, which is found at abnormally high levels in malignant cells of several blood cancers, as well as certain cells involved in inflammation. miRagen’s clinical product candidate for the treatment of pathological fibrosis, MRG-201, is a replacement for microRNA-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as systemic sclerosis. MRG-110, an inhibitor of microRNA-92, is being developed under a license and collaboration agreement with Servier for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen is developing a pipeline of preclinical product candidates. The goal of miRagen’s translational medicine strategy is to progress rapidly to first-in-human studies once it has established the pharmacokinetics, pharmacodynamic, safety and manufacturability of the product candidate in preclinical studies. For more information, please visit www.miragen.com.
For information on clinical trials please visit www.clinicaltrials.gov.
Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, including statements regarding miRagen’s strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management or the expected features of or potential indications for miRagen’s product candidates are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation: that miRagen has incurred losses since its inception, and anticipates that it will continue to incur significant losses for the foreseeable future; future financing activities may cause miRagen to restrict its operations or require it to relinquish rights; miRagen may fail to demonstrate safety and efficacy of its product candidates; miRagen’s product candidates are unproven and may never lead to marketable products; miRagen’s product candidates are based on a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all; miRagen’s product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval; and the results of miRagen’s clinical trials to date are not sufficient to show safety and efficacy of miRagen’s product candidates and may not be indicative of future clinical trial results. miRagen has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in miRagen’s Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. Moreover, miRagen operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.
Miragen Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended
|Research and development||6,413||4,120|
|General and administrative||2,990||3,281|
|Total operating expenses||9,403||7,401|
|Loss from operations||(4,619||)||(6,939||)|
|Other income (expense):|
|Interest and other income||167||30|
|Interest and other expense||(209||)||(71||)|
|Accretion of redeemable convertible preferred stock to redemption value||—||(5||)|
|Net loss available to common stockholders||$||(4,661||)||$||(6,985||)|
|Net loss per share, basic and diluted||$||(0.18||)||$||(0.60||)|
|Weighted-average shares used to compute basic and diluted net loss per share||26,483,112||11,555,286|
Miragen Therapeutics, Inc.
Selected Financial Information
Condensed Consolidated Balance Sheet Data
(amounts in thousands)
|Cash and cash equivalents||$||78,099||$||47,441|
|Total stockholders’ equity||$||72,706||$||38,510|
Chief Business Officer