miRagen Therapeutics Reports Second Quarter 2017 Financial Results and Provides Corporate Update
August 11 2017 - 4:05PM
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
- Reported new interim MRG-106 Phase 1 clinical trial
results, and announced plans to expand the program to include
additional potential indications: New interim results from
the Company’s ongoing Phase 1 clinical trial of MRG-106 in subjects
with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma
(CTCL) were presented at the American Society of Clinical Oncology
(ASCO) Annual Meeting in June 2017. Eighteen of nineteen subjects
(95%), independent of administration route, showed improvement in
either the individual lesion or total skin disease as measured by
maximal change in either Composite Assessment of Index Lesion
Severity or modified Severity Weighted Assessment Tool (mSWAT),
respectively.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.
- Completed MRG-201 Phase 1 clinical trial, and final
clinical trial results planned to be presented in second half of
2017: The double-blind, placebo-controlled, single and
multiple dose-escalation Phase 1 trial evaluating MRG-201 in
induced cutaneous fibrosis has been completed, and the Company
plans to present final clinical trial results at a scientific
conference before the end of this year. In 2018, the Company
intends to initiate a Phase 2a trial to evaluate MRG-201 in
subjects with a predisposition for keloid formation. Future
indications to be studied for miR-29 replacements could include
other fibrotic diseases of the eye and the lung.
- MRG-110 to advance into clinical development in
2018: miRagen plans to advance MRG-110, a microRNA-based
therapy being developed in collaboration with Servier, into
clinical development next year. MRG-110, the lead product candidate
under the collaboration, inhibits the activity of microRNA-92a,
which has been reported in multiple peer reviewed scientific
publications to be a regulator of new blood vessel creation. This
may indicate that MRG-110 could be useful in the treatment of
cardiovascular disease and certain other diseases where vascular
flow is compromised.
- Announced changes to the Company’s Board of
Directors: miRagen appointed Chris Bowden, M.D. and
Jeffrey Hatfield to the Company's Board of Directors effective
August 10, 2017, following the resignations of John Creecy and
Kyle Lefkoff. miRagen believes that the biopharmaceutical expertise
of Dr. Bowden and Mr. Hatfield will be invaluable as the Company
advances and expands its pipeline of microRNA-targeted therapies.
miRagen would like to thank Mr. Creecy and Mr. Lefkoff for their
significant and valued contributions to the Company.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
the Roche Group.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.
- miRagen Therapeutics added to the Russell 2000® and
3000® Indexes: The Company has been included in the
Russell 2000® and Russell 3000® Indexes following Russell
Investments’ reconstitution of its comprehensive set of U.S. and
global equity indexes in June 2017. The Russell 2000® Index
measures the performance of the small-cap segment of the U.S.
equity market, and is a subset of the Russell 3000® Index.
Anticipated Milestones
- MRG-106 (hematological malignancies) ° Interim Phase 1
CTCL data presentation at ASH (Q4 2017) ° Phase 1 trial
expansion to include ATLL, DLBCL and CLL (2H 2017) °
Initiation of a Phase 2 trial in CTCL/Non-Hodgkin’s lymphoma (2H
2018)
- MRG-201 (pathologic fibrosis) ° Phase 1 results
presentation at a scientific conference (2H 2017) °
Initiation of a Phase 2a trial in keloids (2018)
- MRG-110 (ischemic disease) ° Completion of
Investigational New Drug/Clinical Trial Application enabling
studies (Q4 2017) ° Initiation of a Phase 1 trial (2018)
Upcoming Events
miRagen plans to present at the following upcoming
conferences:
- Wedbush PacGrow Healthcare Conference, New York, NY August
15-16, 2017
- European Respiratory Society, Milan, Italy September 9,
2017
- Cantor Fitzgerald Global Healthcare Conference, New York, NY
September 25-27, 2017
- DIA Oligonucleotide-Based Therapeutics Conference, Bethesda, MD
October 25, 2017
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.
- Revenue decreased to $0.7 million during the second quarter of
2017, from $1.1 million during the same period in 2016. The $0.4
million decrease was due primarily to decreases in license fee and
development related revenue under the Company’s collaboration
agreement with Servier.
- Research and development expenses increased to $5.5 million
during the second quarter of 2017, from $3.4 million during the
same period in 2016. The $2.1 million increase was due primarily to
a $1.3 million increase in outsourced manufacturing expenses, a
$0.3 million increase in clinical trial expense, and a $0.8 million
increase in personnel costs, including share based compensation.
These increases were partially offset by a $0.3 million decrease in
outsourced preclinical costs.
- General and administrative expenses increased to $2.6 million
during the second quarter of 2017, from $1.2 million during the
same period in 2016. The $1.4 million increase was due primarily to
a $0.8 million increase in legal and other professional fees and
expenses related primarily to increased costs associated with being
a public company and increased personnel costs of $0.4 million,
including share based compensation.
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
Miragen Therapeutics (NASDAQ:MGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Miragen Therapeutics (NASDAQ:MGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024