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BOULDER, Colo., March 14, 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 fourth quarter and full year 2017 financial results and provided a corporate update.
“2017 was a remarkable year for miRagen, underscored by the clinical success and advancement of our two lead programs, cobomarsen (MRG-106) and MRG-201, and we believe we are well-positioned to make advances in the development of our product candidates in 2018,” said miRagen President and Chief Executive Officer William S. Marshall, Ph.D. “The cobomarsen Phase 1 results have been encouraging, and we plan to initiate a Phase 2 clinical trial to evaluate cobomarsen in cutaneous T-cell lymphoma (CTCL) this year. We have designed this trial to allow the possibility of accelerated approval in the United States, subject to the outcome of the trial. In 2018, we expect to initiate four clinical trials, including the Phase 2 SOLAR trial evaluating cobomarsen in CTCL, a Phase 2 trial for MRG-201 in cutaneous fibrosis and two Phase 1 trials in collaboration with Servier for MRG-110 to support development in ischemic diseases. Additionally, in 2018 we expect to report interim data from our Phase 1 trial evaluating cobomarsen in multiple hematological malignancies beyond CTCL.”
Business Highlights and Update
Conference Call Information
miRagen will host a conference call today at 4:30 p.m. ET to discuss its financial results for the fourth quarter and full year 2017. Participants may access the call by dialing (800) 289-0438 in the U.S. or (323) 994-2083 outside the U.S. and providing the conference ID number 5740056. The call will also be webcast and can be accessed from the Investors and Media section of the Company’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’s two lead product candidates, cobomarsen (MRG-106) and MRG-201, are currently in clinical development. miRagen’s clinical product candidate for the treatment of certain cancers, cobomarsen (MRG-106), 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. miRagen is also developing MRG-110, an inhibitor of microRNA-92, under a license and collaboration agreement with Servier. MRG-110 is being developed for the treatment of heart failure and other ischemic diseases. 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, and as a result miRagen cannot guarantee that it will be able to start, or cause its clinical trials to progress, on the schedule it currently anticipates; 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 results of miRagen’s Phase 1 clinical trials 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.
Chief Business Officer
|Miragen Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended|
|Research and development||4,998||3,906||19,623||13,692|
|General and administrative||2,548||2,517||10,912||6,772|
|Total operating expenses||7,546||6,423||30,535||20,464|
|Loss from operations||(6,354||)||(5,914||)||(26,532||)||(16,987||)|
|Other income (expense):|
|Interest and other income||158||16||403||39|
|Interest and other expense||(190||)||(76||)||(383||)||(326||)|
|Accretion of redeemable convertible preferred stock to redemption value||—||(12||(5||)||(49||)|
|Net loss available to common stockholders||$||(6,386||)||$||(5,986||)||$||(26,517||)||$||(17,323||)|
|Net loss per share, basic and diluted||$||(0.29||)||$||(9.20||)||$||(1.38||)||$||(28.21||)|
|Weighted-average shares used to compute basic and diluted net loss per share||22,297,302||650,799||19,244,605||614,017|
|Miragen Therapeutics, Inc.|
|Selected Financial Information|
|Condensed Consolidated Balance Sheet Data|
|(amounts in thousands)|
|Cash and cash equivalents||$||47,441||$||22,104|
|Notes payable, inclusive of current portion||$||9,922||$||4,789|
|Redeemable convertible preferred stock||$||—||$||76,976|
|Total stockholders’ equity (deficit)||$||38,510||$||(61,921||)|
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