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7 HTG Molecular (HTGM) is a commercial stage company that develops and markets products and services based on proprietary technology that facilitates the routine use of targeted molecular profiling. Molecular profiling is the collection of information about multiple molecular targets, such as DNA and RNA, also called biomarkers, in a biological sample. Molecular profiling information has many important applications, from basic research to molecular diagnostics in personalized medicine. Its technology can be used throughout that range of applications, which is just one of its many benefits. Its focus is on clinical applications. Its primary customer segments include biopharmaceutical companies, academic research centers and molecular testing laboratories.{{footnote}}{{/footnote}}
9 Historically, molecular profiling has faced several technical challenges in clinical applications. These include (i) limited “multiplexing,” which means only a few biomarkers could be tested in a single sample; (ii) the need for vast amounts of sample to test more than a few biomarkers, which often required several different technologies conducted in different locations; (iii) complex sample preparation; and (iv) manual and/or time-consuming workflows. Even where it was possible to test tens, hundreds or thousands of biomarkers, such as with fixed arrays, data analysis could be quite complicated and time consuming.
11 HTG Molecular's proprietary technology has several key differentiators, including (i) multiplexing from tens to thousands of biomarkers in a single sample; (ii) very low sample input requirements; (iii) simple, extraction-free sample preparation, which is effective with a wide variety of samples; (iv) automated workflow with sample-to-result turnaround times rivaling any current competitor; and (v) simplified data output. In addition, its HTG EdgeSeq assay technology, launched in 2014, generates a molecular profiling library for detection using NGS. Among other things, NGS provides improved sensitivity and dynamic range for its HTG EdgeSeq assays. The company believe these advantages position it to outperform most other now-available molecular profiling technologies, especially in certain sample types, such as formalin-fixed, paraffin-embedded, or FFPE, tissue. While the company continue to advance its technology, HTG Molecular is particularly focused on gaining market recognition and expanding its product offerings and biopharmaceutical company collaborations.
13 HTG Molecular's current sources of revenue include sample processing, custom research use only, or RUO, assay development and collaboration services and sales of its automation systems and integrated NGS-based HTG EdgeSeq assays. Its current assay product offerings include the following:
15 * HTG EdgeSeq Oncology Biomarker Panel,
16 * HTG EdgeSeq Immuno-Oncology Assay,
17 * HTG EdgeSeq microRNA Whole-Transcriptome Assay,
18 * HTG EdgeSeq DLBCL Cell of Origin Assay,
19 * HTG EdgeSeq DLBCL Cell of Origin Assay EU,
20 * HTG EdgeSeq PATH Assay, and
21 * HTG EdgeSeq ALKPlus Assay EU.
23 HTG Molecular's assays are currently sold for research use only, except in Europe where its diffuse large B-cell lymphoma, or DLBCL, assay and its HTG EdgeSeq ALKPlus Assay EU are CE-marked and available for diagnostic use. The company continue work on the pre-market approval, or PMA, submission for its HTG EdgeSeq ALKPlus Assay in the United States. The company also have a focused development pipeline of new profiling products, which includes planned panels for translational research, drug development, and molecular diagnostics with initial focus in immuno-oncology. HTG Molecular has completed feasibility testing on its direct-target-sequencing “version 2” chemistry, or V2 chemistry, which is now available as a service offering for detection of certain DNA mutations in its VERI/O laboratory.
25 The company's HTG EdgeSeq assays are automated on either its HTG Edge or HTG EdgeSeq platform, which may also be referred to as an “instrument” or “processor” and which, together with the assay, is a fully integrated system. Its HTG Edge platform can run both its original, plate-based assays and its NGS-based HTG EdgeSeq assays. The company continue to support a small number of customers interested in utilizing its plate-based assays on a custom manufacturing basis; however, in 2016, based on market trends and customer feedback, the company shifted its product focus to its NGS‑based HTG EdgeSeq system.
27 Customers can also obtain the advantages of its proprietary technology by engaging it to perform certain pre-clinical and clinical research-related services, including drug development and translational research. Its services include processing samples for molecular profiling data and designing custom research or investigational profiling assays.
29 As the company navigate product-related regulatory requirements to launch additional molecular diagnostic products, initially in Europe and then in the United States, the company expect its research products and services will continue to drive market recognition and technology adoption. Further, the company expect that strategically positioning its proprietary technology, products and services in drug or other clinical development programs will drive a future, ongoing portfolio of molecular diagnostic products, including companion diagnostic products.
31 HTG Molecular has incurred significant losses since its inception, and HTG Molecular has never been profitable. The company incurred net losses of $5.8 million and $11.7 for the three and six months ended June 30, 2017, respectively, and $6.9 million and $13.9 for the three and six months ended June 30, 2016, respectively. As of June 30, 2017, the company had an accumulated deficit of approximately $127.3 million. As of June 30, 2017, the company had available cash and cash equivalents totaling approximately $13.4 million, and had current liabilities of approximately $10.6 million, plus an additional $10.6 million in long-term liabilities primarily attributable to its Growth Term Loan and its obligation to NuvoGen.
33 = Recent Developments =
35 In April 2017, the company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent, pursuant to which the company may offer and sell, from time to time, through Cantor Fitzgerald, shares of its common stock by any method deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act, or the ATM Offering, and filed a prospectus supplement (File No. 333-216977) with the SEC relating to the offer and sale of up to $20,000,000 of common stock in the ATM Offering. In June 2017, the company filed an amendment to the prospectus supplement with the SEC to increase the amount of common stock that may be offered and sold in the ATM Offering to $40,000,000 in the aggregate, inclusive of the common stock previously sold in the ATM Offering prior to the date of the amendment. As of August 4, 2017, HTG Molecular has sold 3,274,341 shares of common stock in the ATM Offering at then-market prices for total gross proceeds of approximately $15.6 million. After sales commissions and other expenses payable by it in connection with the ATM Offering, its aggregate net proceeds from the ATM Offering through August 4, 2017 were approximately $14.9 million.
37 In June 2017, the company announced that its new HTG EdgeSeq PATH Assay for research uses had been launched for sale in the United States and Europe. The HTG EdgeSeq PATH Assay was designed for retrospective gene expression profiling to complement traditional immunohistochemistry, or IHC, testing.
39 In June 2017, the company amended and restated its IVD Test Development and Component Supply Agreement with Illumina, Inc. to, among other things, extend the agreement term and increase the number of in-vitro diagnostic test kits that may be developed for use with Illumina sequencing technology.
41 In June 2017, the company entered the first statement of work, or SOW One, with QIAGEN Manchester Limited, or QML, under the parties’ Master Assay Development, Commercialization and Manufacturing Agreement, or the Governing Agreement. SOW One addresses development activities expected to be conducted by it and QML in connection with the initial phase of a sponsored project agreement entered into between QML and a pharmaceutical company. Under SOW One, the company and QML are expected to perform development work for the initial phase of what is expected to become a multi-stage project leading to the potential development and commercialization of a next generation sequencing-based companion diagnostic assay. The development work is expected to support one of the pharmaceutical company’s therapeutic development and commercialization programs
43 In July 2017, the company announced the initiation of its second development program with QML, under the Governing Agreement. Its HTG EdgeSeq technology will be used in the program to develop gene expression profiling assays for use with NGS technology in support of another pharmaceutical company’s therapeutic development and commercialization programs.
45 = References =
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