HTG Receives First Commercial Orders for its Planned HTG Transcriptome Panel and Announces the Signing of Two European Early Adopter Program Agreements

TUCSON, Ariz. — HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced it has received the first commercial orders for its planned HTG Transcriptome Panel and has signed agreements with its first two Early Adopter Program (EAP) collaborators in Europe. HTG has now signed EAP agreements with customers in both the US and Europe and continues to progress toward its planned third quarter 2021 commercial launch of its HTG Transcriptome Panel, designed to measure approximately 20,000 mRNA targets using the HTG EdgeSeq technology.

Entering into additional EAP agreements with new and existing customers allows for additional studies which HTG believes will support validation of the HTG Transcriptome Panel’s performance requirements. This program also provides these collaborators with access to this panel in advance of the planned commercial launch in the third quarter of 2021. Through this process HTG has also received its first commercial orders for the HTG Transcriptome Panel from EAP collaborators and has signed EAP agreements with customers in both the US and Europe.

“Several prestigious cancer centers and research institutions throughout the US and Europe have expressed interest in our planned HTG Transcriptome Panel and are now participants or have indicated their intention to participate in the EAP. In the past week, we executed EAP agreements with Fundación Instituto Valenciano de Oncologia (Valencia, Spain) and Tyrolpath Obrist Brunhuber GmbH (Zams, Austria), two top European institutions at the leading edge of precision medicine solutions, with a focus on the use of novel technologies like our HTG EdgeSeq technology,” said Byron Lawson, Senior Vice President and Commercial Officer.

“We believe our first commercial orders for the HTG Transcriptome Panel in advance of our official launch demonstrates significant enthusiasm about the opportunities for this panel. We are very pleased to have initial orders from customers in both the US and Europe, and in both the academic and biopharma sectors,” Mr. Lawson continued.

About HTG:
HTG is focused on NGS-based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Its mission is to empower precision medicine.

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 regarding: our planned HTG Transcriptome Panel, including the timing of its planned commercial launch and its expected capabilities and performance; HTG’s belief that EAP studies will support validation of the HTG Transcriptome Panel’s performance requirements; potential future participation by cancer centers and research institutions in the EAP;; the utility and use of our HTG EdgeSeq technology; and our ability to grow our customer base and penetrate new markets. Words such as “believe,” “will,” “planned,” “intend” and similar expressions are intended to identify forward-looking statements, although 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, risks associated with the impact of the COVID-19 pandemic on us and our customers; the risk that our HTG EdgeSeq technology may not have the utility and be used by our customers as we expect; risks associated with our ability to develop and commercialize our products, including the HTG Transcriptome Panel; 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 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 period ended March 31, 2021. 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.

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