On March 31, 2017, the Company issued a press release announcing
that its MRG-106 product candidate has received approval for orphan-drug designation for the treatment of mycosis fungoides. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by
reference,
As described in Items 2.02 and 7.01 above, on March 31, 2017, the Company issued a press release with respect to the
Companys anticipated milestones for certain of its product candidates in 2017. These milestones include:
MRG-106
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Present interim data for Phase 1 clinical trial at the 2017 meeting of the American Society of Clinical Oncology (Second Quarter 2017)
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Expand Phase 1 clinical trial to include a second indication (Second Half 2017)
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Present interim data for Phase 1 clinical trial at ASH (Fourth Quarter 2017)
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MRG-201
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Dose last patient in Phase 1 clinical trial (First Half 2017)
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Present results of Phase 1 clinical trial at a scientific conference (Second Half 2017)
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Note Regarding
Forward-Looking Statements
This Current Report on Form 8-K contains 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 Current Report on Form 8-K other than statements of historical fact, including statements regarding the
Companys 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,
milestones or should, and similar expressions are intended to identify forward-looking statements. Such statements are based on managements 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 the Company has incurred losses since its inception, has a limited operating history on which
to assess its business, and anticipates that it will continue to incur significant losses for the foreseeable future; the Company has never generated any revenue from product sales and may never be profitable; raising additional capital may cause
dilution to the Companys stockholders, restrict its operations or require it to relinquish rights; the Company may be unsuccessful in maintaining orphan-drug designation for its product candidates because even after an orphan drug is
approved, the FDA can subsequently approve a different drug for the same indication if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care;
clinical trials are costly, time consuming and inherently risky, and the Company may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; the approach it is taking to discover and develop novel
therapeutics using microRNA is unproven and may never lead to marketable products; the Companys microRNA therapeutic 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; to date, no microRNA therapeutics have been approved for marketing in the United States; the Company may not be able to develop or identify technology that can effectively
deliver MRG-106, MRG-201 or any other of the Companys microRNA-targeted product candidates to the intended diseased cells or tissues, and any failure in such delivery technology could adversely affect and delay the development of MRG-106,
MRG-201 and the Companys other product candidates; and the Companys product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval, limit the commercial viability of an
approved label, or result in significant negative consequences following marketing approval, if any.
The Company has based these
forward-looking statements largely on its current expectations and projections about future events and trends that it believes may affect its financial condition, results of operations, business strategy, short-term and long-term business operations
and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in under the heading Risk Factors in the Companys Annual Report on
Form 10-K and any subsequent periodic reports filed with the SEC. Moreover, the Company 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. The
Company undertakes no obligation to revise or publicly release the results of any revision to these 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.
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