Full Press Release Details
MIRAGEN THERAPEUTICS REPORTS SECOND QUARTER 2017 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
BOULDER, CO, August 11, 2017 (GLOBE NEWSWIRE)
miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced second quarter 2017 financial results and provided a corporate update.
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
Subsequent to the presentation at the ASCO Annual Meeting, subjects enrolled in the trial
continued to show improvement in their mSWAT scores. As of July 26, seventeen of eighteen subjects treated systemically with MRG-106 showed mSWAT score improvement, and the magnitude of mSWAT improvements generally correlated with amount of
time the subject received MRG-106 treatment. Seven of nine subjects receiving more than one month of dosing of MRG-106 showed a 50% or greater improvement in mSWAT scores. Additionally, subjects receiving the treatment via intravenous (IV) infusion
appear to have improved at a higher rate than those receiving the treatment via subcutaneous injection. MRG-106 has been generally safe and well-tolerated at all dose levels evaluated to date. The Company has also initiated rapid intravenous dosing
in patients after discussing the plan with the U.S. Food and Drug Administration (FDA) during a meeting in June. This route of administration may allow for higher maximal blood concentration and could provide additional convenience to patients.
In May 2017, MRG-106 was granted orphan medicinal product designation for the treatment of CTCL by the European Commission. The FDA granted
orphan drug designation to MRG-106 for the treatment of MF in March 2017. Following a discussion with the FDA in June, the Company plans to evaluate MRG-106 in additional oncology indications within the current Phase 1 trial, including adult T-cell
leukemia/lymphoma (ATLL), diffuse large B-cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL) as in each case the disease process appears to be related to an increase in miR-155 levels. In 2018, the Company intends to initiate a Phase 2
clinical trial with MRG-106 in MF patients.
Dr. Bowden brings substantial experience in clinical drug development to miRagen s
Board of Directors. He currently serves as the Chief Medical Officer of Agios Pharmaceuticals, Inc. Prior to joining Agios, he served as Vice President, Product Development Oncology, Franchise Lead (Signaling Group) at Genentech, Inc., a member of
Mr. Hatfield brings relevant industry experience and a breadth of expertise to miRagen s Board of Directors.
From March 2004 through October 2016, he served as President and Chief Executive Officer of Vitae Pharmaceuticals, Inc., until its acquisition by Allergan in 2016. Prior to working at Vitae, he was with Bristol-Myers Squibb Company serving in
numerous executive capacities, including as Senior Vice President of Bristol-Myers s Immunology and Virology divisions.
Anticipated Milestones
miRagen plans to present at the following upcoming conferences:
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
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
For information on clinical trials please visit www.clinicaltrials.gov.
Note Regarding Forward-Looking Statements
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)
| 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)
| 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 | ) |
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