HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Files An 8-K Other Events
Item 8.01Other Events.
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.
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 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.
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.
