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HTG Molecular Diagnostics, Inc. (65HA.F)

Frankfurt - Frankfurt Delayed price. Currency in EUR
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4.6600-0.0600 (-1.27%)
At close: 8:04AM CET
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Previous close4.7200
Open4.6600
Bid0.0000 x N/A
Ask0.0000 x N/A
Day's range4.6600 - 4.6600
52-week range3.2100 - 11.3249
Volume1,500
Avg. volume356
Market cap23.266M
Beta (5Y monthly)1.44
PE ratio (TTM)N/A
EPS (TTM)-4.7220
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
  • HTG Concludes Feasibility Testing & Releases Second White Paper for its Planned Whole Transcriptome Panel Using HTG EdgeSeq Technology
    GlobeNewswire

    HTG Concludes Feasibility Testing & Releases Second White Paper for its Planned Whole Transcriptome Panel Using HTG EdgeSeq Technology

    TUCSON, Ariz., Feb. 26, 2021 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced it has completed its feasibility testing for a planned whole transcriptome panel using the HTG EdgeSeq technology, and has released a follow-on whole transcriptome product white paper (White Paper Two), regarding the performance of a prototype panel for multiple cancer indications compared to RNA sequencing (RNA-Seq). HTG is developing a whole transcriptome panel using the HTG EdgeSeq technology to measure approximately 20,000 mRNA targets, with a planned research use only launch in the third quarter of 2021. “Since demonstrating initial technical feasibility with our prototype whole transcriptome panel in November 2020, we have continued to iterate our prototype panel, mature the gene content and probe designs and improve the sample preparation process, to reduce background and increase the robustness of the panel across a variety of cancer indications,” said Dr. Marian Navratil, Senior Vice President of Research and Development. “We are very excited to share what we believe is compelling data generated in studies performed since the demonstration of initial feasibility with the release of White Paper Two today. As outlined in this white paper, in addition to an assessment of repeatability of our latest prototype panel, we have completed an evaluation of the accuracy of differential expression analysis using a three-pronged accuracy assessment which included: (1) a comparison to RNA-Seq, (2) independent evaluation of differential expression using external RNA controls consortium (ERCC) control materials, and (3) a tissue mixture study. In all three assessments, the panel demonstrated a high degree of accuracy when measuring differential gene expression and in comparison to RNA-Seq,” continued Dr. Navratil. White Paper Two further demonstrates the feasibility and expected performance of the whole transcriptome prototype panel, including: Ability to differentiate samples based on gene expression profiles – The data generated in the studies demonstrated the ability to generate unique gene expression profiles for multiple cancer indications with comparable sample clustering relative to RNA-Seq. Repeatability with archived samples – In the studies performed, the panel achieved an equally high degree of repeatability amongst replicates from multiple cancer indications in both 5- and 10-year-old formalin-fixed paraffin-embedded (FFPE) samples, with all but one sample requiring only a single FFPE section for sample input, compared with RNA-Seq, which required 4-8 FFPE sections per sample for RNA extraction and 25% of samples failed to generate sufficient extracted RNA material. Accuracy of differential expression – The accuracy of differential expression analysis using a direct comparison to RNA-Seq, and spiked-in reference material in a complex FFPE matrix, was demonstrated in studies across multiple cancer indications. Additionally, a tissue mixture study demonstrated equivalent accuracy of differential expression analysis.Robust alternative to RNA-Seq – These studies demonstrate that the HTG EdgeSeq technology is a robust alternative to RNA-Seq for gene expression profiling, in addition to maintaining advantages such as less sample input, extraction-free chemistry and the ability to test low-quality and limited quantity FFPE tissue specimens. “Now that we have concluded feasibility testing for all elements of the panel’s design, we are proceeding to the optimization phase of this development program, where we expect to further improve the panel’s design, workflow and robustness. Final product design lock is scheduled to occur in the second quarter of 2021, followed by formal design verification and commercialization in the third quarter of 2021,” Dr. Navratil concluded. 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 the benefits of and timing for development and commercialization of our planned whole transcriptome panel, and our expectations for increased demand for our products and services in the future and our ability to meet those demands and for growth in our business. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” 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 we may not establish new and significant collaboration development arrangements; the risk that the planned whole transcriptome panel may not provide the benefits or be developed or commercialized as expected, or at all; the risk that future performance of the planned whole transcriptome panel may not match the performance observed in the studies outlined in White Paper Two; risks associated with our ability to develop and commercialize our products, including a whole 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 quarter ended September 30, 2020. 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. Contact:Ashley R. RobinsonPhone: (617) 430-7577Email: arr@lifesciadvisors.com

  • GlobeNewswire

    HTG Announces Board of Directors Transition

    Timothy Johnson to Retire from the Board; Ann Hanham, Ph.D. Remains Lead Independent DirectorTUCSON, Ariz., Jan. 19, 2021 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced that Timothy (TJ) B. Johnson has resigned his positions as Executive Chairman and a member of HTG’s Board of Directors. Ann F. Hanham, Ph.D. will remain as Lead Independent Director. Mr. Johnson has served as HTG’s Executive Chairman since March 31, 2019 and as a member of the Company’s Board of Directors since January 2008. Mr. Johnson previously served as the Company’s Chief Executive Officer from January 2008 until his transition to Executive Chairman in March 2019. “TJ has been a cornerstone of HTG since 2008. During this time, he has been a passionate advocate for HTG and its mission to advance precision medicine,” said Mr. Lubniewski. “We are grateful for the valuable contributions TJ made to HTG over the years and wish him continued success.” 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. Contact:Ashley R. RobinsonPhone: (617) 430-7577Email: arr@lifesciadvisors.com

  • HTG Molecular Diagnostics Announces Certain Preliminary 2020 Unaudited Financial Results
    GlobeNewswire

    HTG Molecular Diagnostics Announces Certain Preliminary 2020 Unaudited Financial Results

    Preliminary full year 2020 unaudited revenue of $8.5 million Cash, cash equivalents and short-term marketable securities of $28.7 million as of December 31, 2020TUCSON, Ariz., Jan. 05, 2021 (GLOBE NEWSWIRE) --  HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced certain preliminary, unaudited financial results for the year ended December 31, 2020.Total revenue for the full year 2020 is expected to be approximately $8.5 million. Cash, cash equivalents and short-term marketable securities are expected to be approximately $28.7 million as of December 31, 2020.“Clearly COVID-19 impacted our core oncology business as planned studies were delayed and operations in many of our customers’ laboratories were suspended or significantly curtailed,” said John Lubniewski, CEO of HTG. “Despite these challenges, we saw returning strength in our core business in the second half and especially in the fourth quarter of 2020. We successfully advanced our strategies to increase customer diversification into smaller and mid-sized biopharma companies and expand business with large, academic medical centers. In addition, we expanded our market reach beyond oncology into immune response, gaining several new customers and programs in the fourth quarter. Although we cannot predict the extent or duration of COVID-19’s impact on our business in 2021, we are excited about our recent expansion into the immune response market.”Mr. Lubniewski continued, “We also remain very focused on our 20,000 plus gene whole transcriptome product that is in development and have executed several letters of intent with potential collaborators for our early access program in December 2020. We look forward to working with these organizations and believe, with this approach, we will have a successful initial product launch, currently on track for the third quarter of 2021. We believe we have used 2020 to strengthen the company and set the stage for revenue growth in 2021.”The preliminary results set forth above are unaudited, are based on management’s initial review of the company’s results as of and for the year ended December 31, 2020 and are subject to revision based upon the company’s year-end closing procedures and the completion and external audit of the company’s year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that company’s financial results are finalized, and such changes could be material. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2020, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.The company expects to announce full 2020 financial results in advance of its quarterly conference call in March 2021.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 expected revenue and other expected financial results as of and for the year ended December 31, 2020, and regarding our intention to develop and launch a whole transcriptome product, our expectation that letters of intent for our whole transcriptome product will result in us doing business with the counterparty organizations, our expected initial whole transcriptome product launch being successful and occurring in the third quarter of 2021, and our belief that we will have revenue growth in 2021. Words such as “believe,” “expect,” “will,” “potential,” “look forward to,” “on track for” 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, the risk that our actual revenue or other financial results for the full year 2020 may differ materially from those set forth in this press release as a result of the completion of year-end closing procedures, final adjustments, or other developments arising between now and the time that our financial results are finalized; 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 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 quarter ended September 30, 2020. 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.Contact: Ashley R. Robinson LifeSci Advisors, LLC Phone: (617) 430-7577 Email: arr@lifesciadvisors.com