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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Miragen Therapeutics Inc | NASDAQ:MGEN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 23.01 | 23.01 | 23.95 | 0 | 01:00:00 |
“The second quarter of 2017 has been marked by a number of important development milestones as we position the company for additional clinical opportunities,” said miRagen President and Chief Executive Officer, William S. Marshall, Ph.D. “In addition to reporting positive new interim Phase 1 clinical trial data underscoring our belief in the potential of the MRG-106 program, we completed our MRG-201 Phase 1 clinical trial and established a potential path forward for expanding both development programs into additional indications. The results generated in both clinical trials represent significant strides forward in execution of our foothold clinical development strategy. We believe that the continued application of the foothold clinical approach may allow us to expand opportunities for our microRNA targeted therapeutic candidates in the future.”
Business Highlights and Update
Anticipated Milestones
Upcoming Events
miRagen plans to present at the following upcoming conferences:
Second Quarter 2017 Financial Results
Cash and cash equivalents at June 30, 2017 were $46.3 million, compared to $22.1 million at December 31, 2016. Total net cash used in operating and investing activities for the first half of 2017 was approximately $14.1 million. The Company expects that its current cash and cash equivalents will be sufficient to fund its operations through the end of 2018.
Net loss attributable to common stockholders for the second quarter of 2017 was $7.3 million, or $0.34 per share (basic and diluted), compared to $3.5 million or $5.88 per share for the same period in 2016.
Conference Call & Webcast
miRagen’s senior management will host a conference call and live audio webcast today at 4:30 p.m. ET to discuss its second quarter 2017 financial results and provide a corporate update. The conference call is being webcast and can be accessed from the miRagen website, www.miragen.com, under Investors & Media. A replay of the webcast will be available for 90 days. The conference call can also be accessed by dialing 877.440.5803 (U.S./Canada) or 719.325.4801 (international) and providing the passcode 3801268.
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 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 also is developing MRG-110, an inhibitor of microRNA-92, under license and collaboration agreement with Servier. MRG-110 is being developed for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen 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, pharmacodynamic, safety and manufacturability of the product candidate in pre-clinical 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 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.
Miragen Therapeutics, Inc. | |||||||||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||||||
(unaudited) | |||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||||||
Revenue: | |||||||||||||||||||||
Collaboration revenue | $ | 488 | $ | 847 | $ | 498 | $ | 1,764 | |||||||||||||
Grant revenue | 230 | 268 | 682 | 268 | |||||||||||||||||
Total revenue | 718 | 1,115 | 1,180 | 2,032 | |||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Research and development | 5,487 | 3,355 | 9,607 | 6,821 | |||||||||||||||||
General and administrative | 2,581 | 1,210 | 5,862 | 2,202 | |||||||||||||||||
Total operating expenses | 8,068 | 4,565 | 15,469 | 9,023 | |||||||||||||||||
Loss from operations | (7,350 | ) | (3,450 | ) | (14,289 | ) | (6,991 | ) | |||||||||||||
Other income (expense): | |||||||||||||||||||||
Interest and other income | 102 | 9 | 132 | 16 | |||||||||||||||||
Interest and other related expense | (64 | ) | (83 | ) | (135 | ) | (172 | ) | |||||||||||||
Net loss | (7,312 | ) | (3,524 | ) | (14,292 | ) | (7,147 | ) | |||||||||||||
Accretion of redeemable convertible preferred stock to redemption value | — | (12 | ) | (5 | ) | (24 | ) | ||||||||||||||
Net loss available to common stockholders | $ | (7,312 | ) | $ | (3,536 | ) | $ | (14,297 | ) | $ | (7,171 | ) | |||||||||
Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (5.88 | ) | $ | (0.87 | ) | $ | (11.92 | ) | |||||||||
Weighted-average shares used to compute basic and diluted net loss per share | 21,409,708 | 601,667 | 16,509,719 | 601,667 |
Miragen Therapeutics, Inc. | ||||||||||
Selected Financial Information | ||||||||||
Condensed Consolidated Balance Sheet Data | ||||||||||
(amounts in thousands) | ||||||||||
(unaudited) | ||||||||||
June 30, 2017 | December 31, 2016 | |||||||||
Cash and cash equivalents | $ | 46,335 | $ | 22,104 | ||||||
Total assets | 50,026 | 24,760 | ||||||||
Notes payable, inclusive of current portion | 3,850 | 4,789 | ||||||||
Total liabilities | 8,690 | 9,705 | ||||||||
Redeemable convertible preferred stock | — | 76,976 | ||||||||
Total stockholders’ equity (deficit) | 41,336 | (61,921 | ) | |||||||
Investor/Media Contact: Adam Levy Chief Business Officer (720) 407-4595 alevy@miragen.com
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