htgm-8k_20190614.DOCX.htm

Delaware

001-37369

86-0912294

(State or other jurisdiction

of incorporation)

(Commission

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(IRS Employer

Identification No.)

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:

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Common Stock, $0.001 par value per share

HTGM

The Nasdaq Stock Market LLC

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).

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. ☒

As previously disclosed, under the Master Assay Development, Commercialization and Manufacturing Agreement between HTG Molecular Diagnostics, Inc. (the “Company”) and QIAGEN Manchester Limited (the “Master Agreement”), the Company has been awaiting certain near-term third-party decisions as to whether a Company assay would be included in one or more additional trials, with a view to supporting a companion diagnostic regulatory submission. The Company has been notified that one such decision has been made to not utilize a Company assay as the basis for a companion diagnostic regulatory submission. Development activities are expected to continue under both active statements of work under the Master Agreement, with additional possible opportunities for the development and potential commercialization of a next-generation sequencing-based companion diagnostic assay in support of one or more therapeutic product candidate development and commercialization programs in the future.

The Company expects that its program pipeline under the Master Agreement will continue to be dynamic, including with respect to the possible initiation of new programs, the commencement, suspension, termination and/or completion of certain trials and the possibility that one or more regulatory submissions will be made.

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 about the activities expected to occur in connection with the active statements of work entered into under the Master Agreement. 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 the statements of work entered into under our Master Agreement may not provide the expected benefits; the risk that we may not realize the benefits expected under our collaboration agreements; risks associated with our ability to successfully commercialize our products; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; our ability to manufacture our products to meet demand; the level and availability of third party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. 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 March 31, 2019. All forward-looking statements contained in this press release 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.

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.




Date: June 14, 2019	HTG Molecular Diagnostics, Inc.

	By:	/s/ Shaun D. McMeans
		Shaun D. McMeans
		Senior Vice President and Chief Financial Officer