HTG Molecular Diagnostics Expands its Collaboration with Merck KGaA, Darmstadt, Germany

Signs Master Collaboration Agreement for Assay Development and Manufacturing of Kits Supporting Biomarker Research Programs

TUCSON, Ariz. and DARMSTADT, Germany, Dec. 26, 2017 -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments, reagents and services for molecular profiling applications today announced a new Master Collaboration Agreement for translational programs with Merck KGaA, Darmstadt, Germany, a leading science and technology company. The Master Collaboration Agreement complements the 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.

“We are pleased to expand our relationship with Merck KGaA, Darmstadt, Germany, into earlier research stages of their programs, and have already begun work on an initial custom assay development program,” said TJ Johnson, President and Chief Executive Officer of HTG. “They are terrific partners, and we appreciate the confidence their teams have placed in us and our HTG EdgeSeq technology.”

Under the first program statement of work, HTG plans 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.

About HTG:
Headquartered in Tucson, Arizona, the mission of HTG Molecular Diagnostics (HTG) is to empower precision medicine at the local level. The company’s HTG EdgeSeq technology, which automates highly multiplexed molecular profiling of small samples for next-generation sequencing, received its first US patent in 2014. Continuous improvements led to the 2017 launch of HTG’s new direct-target sequencing chemistry for DNA analysis offered in the company’s VERI/O services laboratory. Additional information is available at www.htgmolecular.com.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany, generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the “Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Safe Harbor Statement:
Statements contained in this press release 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 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.

HTG Contacts: 
Ashley Robinson
LifeSci Advisors, LLC
Phone: 617-775-5956
Email: [email protected]

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: [email protected]