BOULDER, Colo., May 10, 2017 (GLOBE NEWSWIRE) -- Miragen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA-targeted therapies, today announced first quarter 2017 financial results and provided a corporate update.
“It has been an exciting and productive first quarter of 2017, with encouraging business developments and clinical progress to report,” said William S. Marshall, Ph.D., president and chief executive officer of miRagen Therapeutics. “We continue to be encouraged by the interim results from our MRG-106 and MRG-201 Phase 1 clinical trials, and plan to provide updated clinical data at scientific conferences throughout the year. We also completed a merger to become a public company and concurrent financing during the quarter. With a cash runway through 2018, we believe we are well-positioned to deliver clinical data from our existing trials, expand these trials, and provide additional data that may broaden the potential clinical applications of our lead programs.”
Business Highlights and Update
Upcoming Events
miRagen plans to participate in the following upcoming scientific, medical and industry conferences:
The Company plans to participate in the following upcoming investor conferences:
First Quarter 2017 Financial Results
Cash and cash equivalents at March 31, 2017 were $54.3 million, compared to $22.1 million at December 31, 2016. The increase in cash and cash equivalents was primarily attributable to $39.5 million in net proceeds received from miRagen’s private placement, partially offset by cash used in operations. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations through 2018.
Net loss attributable to common stockholders for the first quarter of 2017 was $7.0 million, or $0.60 per share (basic and diluted), compared to $3.6 million or $5.58 per share for the same period in 2016.
Conference Call
The miRagen Therapeutics management team will host a conference call and webcast today at 4:30 p.m. ET to discuss a corporate update and financial results for the first quarter 2017. The conference call can be accessed by dialing (888) 430-8709 (U.S./Canada) or (719) 457-2714 (international) and providing the passcode 3263108. A live audio webcast will be available in the Investors section of the miRagen Therapeutics website at www.miragenrx.com.
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, MRG-106 and MRG-201, are currently in Phase 1 clinical trials. miRagen’s clinical product candidate for the treatment of certain cancers, MRG-106, is an inhibitor of microRNA-155, which is found at abnormally high levels in several blood cancers. miRagen’s clinical product candidate for the treatment of pathological fibrosis, MRG-201, is a replacement for miR-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, and pulmonary fibrosis, as well as systemic sclerosis. In addition to miRagen’s clinical programs, it is developing a pipeline of pre-clinical 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, pharmacodynamics and safety of the product candidate in pre-clinical studies. For more information, please visit www.miragenrx.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 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; and miRagen’s product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval.
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) | |||||||
(unaudited) | |||||||
Three Months Ended March 31, | |||||||
2017 | 2016 | ||||||
Revenue: | |||||||
Revenue under strategic alliance and collaboration | $ | 10 | $ | 917 | |||
Grant revenue | 452 | — | |||||
Total revenue | 462 | 917 | |||||
Operating expenses: | |||||||
Research and development | 4,120 | 3,466 | |||||
General and administrative | 3,281 | 992 | |||||
Total operating expenses | 7,401 | 4,458 | |||||
Loss from operations | (6,939 | ) | (3,541 | ) | |||
Other income (expense): | |||||||
Interest and other income | 30 | 7 | |||||
Interest and other related expense | (71 | ) | (89 | ) | |||
Net loss | (6,980 | ) | (3,623 | ) | |||
Accretion of redeemable convertible preferred stock to redemption value | (5 | ) | (12 | ) | |||
Net loss available to common stockholders | $ | (6,985 | ) | $ | (3,635 | ) | |
Net loss per share, basic and diluted | $ | (0.60 | ) | $ | (5.58 | ) | |
Weighted-average shares used to compute basic and diluted net loss per share | 11,555,286 | 651,041 |
Miragen Therapeutics, Inc. | |||||||
Selected Financial Information | |||||||
Condensed Consolidated Balance Sheets | |||||||
(amounts in thousands) | |||||||
(unaudited) | |||||||
March 31, 2017 | December 31, 2016 | ||||||
Cash and cash equivalents | $ | 54,273 | $ | 22,104 | |||
Total assets | 57,794 | 24,760 | |||||
Notes payable, inclusive of current portion | 4,321 | 4,789 | |||||
Total liabilities | 9,800 | 9,705 | |||||
Redeemable convertible preferred stock | — | 76,976 | |||||
Total stockholders’ equity (deficit) | 47,994 | (61,921 | ) |