HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Files An 8-K Other EventsItem 8.01Other Events.
On March 30, 2018, HTG Molecular Diagnostics, Inc. (the “Company”) and QIAGEN Manchester Limited (“QIAGEN”), a U.K. corporation and wholly owned subsidiary of QIAGEN N.V., entered a second amendment of the first statement of work (“SOW One”) under the parties’ Master Assay Development, Commercialization and Manufacturing Agreement (such amendment, the “Second SOW One Amendment”). SOW One was first amended on December 18, 2017.
SOW One, dated June 14, 2017, as amended, relates to the development of a next generation sequencing-based investigational‑use diagnostic assay (the “Project”) that is the subject of a sponsor project agreement between QIAGEN and a pharmaceutical company (“Pharma One”).
Development activities under SOW One, as first amended, are complete, and the Second SOW One Amendment relates to next-phase development activities, including assay design verification and preparation for regulatory submission, for the Project (“Next-Phase Activities”). QIAGEN has agreed to pay the Company low, single-digit millions of dollars in development fees for the Next-Phase Activities. QIAGEN has also agreed to pay the Company milestone payments up to an amount in the low, single-digit millions of dollars in the aggregate upon the achievement of certain development milestones during the Next-Phase Activities. The Next-Phase Activities are expected to be completed in the second quarter of 2018. Successful completion of the Next-Phase Activities is expected to lead to further Project development activities and the potential commercialization of a companion diagnostic assay for a corresponding Pharma One drug.
QIAGEN North American Holdings, Inc., a wholly owned subsidiary of QIAGEN N.V., owns 833,333 shares of the Company’s common stock, and holds a Subordinated Convertible Promissory Note issued by the Company in the principal amount of $3.0 million.
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 about the anticipated benefits or outcomes of SOW One, as amended, and the potential development and commercialization of a companion diagnostic 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 the development activities contemplated by SOW One, as amended, may not be performed as expected, or at all, the risk that the development work under SOW One, as amended, may not support the development and commercialization of a companion diagnostic assay, risks associated with the process of developing, marketing and commercializing the Company’s products, the Company’s ability to achieve and sustain sufficient market acceptance, and the capabilities of the Company’s product and service solutions to keep pace with rapidly changing technology and customer requirements. These and other factors are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. All forward-looking statements contained in this report speak only as of the date on which they were made, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
About HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM)
HTG Molecular Diagnostics, Inc. is a commercial-stage company that develops and markets a technology platform to facilitate the routine use of complex molecular profiling. The Company’s HTG Edge and HTG EdgeSeq platforms, consisting of instrumentation, consumables and software analytics, are used in sample profiling applications, including tumor profiling, molecular diagnostic testing and biomarker development. The Company’s HTG Edge and HTG EdgeSeq platforms automate the molecular profiling of genes and gene activity using its nuclease protection chemistry on a range of biological samples. The Company’s HTG EdgeSeq chemistry, together with its HTG Edge or HTG EdgeSeq instrumentation and software, automates and adapts its nuclease protection chemistry to enable analysis using next generation sequencing (NGS) instrumentation. The HTG EdgeSeq system utilizes substantially the same sample preparation reagents as its original chemistry, but allows for read out on an NGS instrument.