UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 26, 2017

HTG Molecular Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: (877) 289-2615

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒ 

On December 26, 2017, we issued a press release announcing our entry into a new Master Collaboration Agreement for translational programs with Merck KGaA, Darmstadt, Germany.  The Master Collaboration Agreement complements our previously announced Master Companion Diagnostic Agreement with Merck KGaA, Darmstadt Germany and includes a statement of work with EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the United States and Canada.

Under the first program statement of work, we plan to develop and manufacture a custom profiling assay to support biomarker research for six indications within Merck KGaA, Darmstadt, Germany’s drug development pipeline.  The assay is expected to be kitted for use on HTG EdgeSeq instruments acquired by Merck KGaA and/or their contract research organization partners.

Forward Looking Statements

Statements contained in this report regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the new Master Collaboration Agreement with Merck KGaA, including our plans to develop and manufacture a custom profiling assay to support biomarker research for six indications within Merck KGaA’s drug development pipeline and the expected use and benefits of the assay. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the risk that development, manufacturing and other activities initiated under the Master Collaboration Agreement may not be performed as expected, or at all, risks inherent in the development of a custom profiling assay for specific indications, risks associated with the utility of our profiling panels, instruments and solutions, and risks associated with our ability to successfully manufacture and supply our products. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including, without limitation, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. All forward-looking statements contained in this report speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.