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    HTG Molecular Diagnostics Reports Third Quarter 2021 Results

    11/10/21 4:05:00 PM ET
    $HTGM
    Biotechnology: Laboratory Analytical Instruments
    Industrials
    Get the next $HTGM alert in real time by email

    TUCSON, Ariz., Nov. 10, 2021 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, today reported its financial results for the quarter ended September 30, 2021.

    Recent Business Highlights

    • Total revenue for the quarter ended September 30, 2021 increased by approximately 42% when compared to the same period in 2020.



    • HTG Transcriptome Panel revenue increased in the third quarter and accounted for 27% and 18% of consumables product revenue for the three and nine months ended September 30, 2021, respectively.



    • Continued collaboration with participants in the Early Adopter Program (EAP) for the Company's HTG Transcriptome Panel (HTP) throughout the US and EU who are exploring potential applications for the panel in their research and clinical programs. EAP collaborators are expected to assist HTG with customer testimonials, white papers, technical notes and peer-reviewed publications highlighting their use of the HTP and their overall experience relative to alternative technologies.



    • Completed an audit of HTG's quality management system for continued certification to ISO 13485:2016, valid through June 2024.



    • Announced the creation of a drug discovery business unit, HTG Therapeutics, and the hiring of the leadership team for the unit. HTG Therapeutics is expected to leverage HTG's proprietary RNA profiling technology platform to inform advanced chemical library designs seeking to improve efficacy and lower toxicity profiles for drug candidates. The team has signed up several KOL's to assist in the development of a portfolio of potentially licensable drug candidates for drug discovery. This effort is aimed at the generation of high-quality primary data from our proprietary profiling platform from known and well annotated cohorts and overcoming the notable shortfalls of data mined from public sources. HTG Therapeutics intends to leverage the Company's past experience partnering with biopharma to collaborate throughout the drug development process, with a view toward creating future revenue and opportunities for HTG.

    "Our profiling revenue has continued to grow quarter over quarter in 2021, reflecting the efforts of our employees and our customers' response to and recovery from the challenges imposed on our industry and by the many challenges we faced as a company in 2020," said John Lubniewski, President and CEO of HTG. "Increasing instrument placements resulting from the reopening of customer facilities and increased sample processing activity in our VERI/O laboratory drove our quarterly growth. A resurgence of consumable product orders from existing and new customers is expected to drive continued growth in our product revenue. Our commercial team remains focused on our strategic priorities of customer and market diversification, while continuing to strengthen relationships with our existing customers.

    "We will continue this drive throughout the remainder of 2021, with expected increasing demand for our HTP," Mr. Lubniewski added. "Our HTG Therapeutics team continues to make strides toward our vision for disrupting drug discovery by using advanced transcriptomic profiling capabilities to de-risk drug candidate development."

    Third Quarter 2021 Financial Highlights:

    Total revenue for the quarter ended September 30, 2021 was $2.5 million, compared with $1.8 million for the same period in 2020.

    Product and product-related services revenue increased by 48% for the quarter ended September 30, 2021 to $2.5 million, compared with $1.7 million for the same period in 2020. This reflects an increase in instrument sales and RUO sample processing services for which demand has begun to recover to pre-COVID-19 levels as customers have resumed development activities. Revenue for the quarter ended September 30, 2020 included $0.1 million of collaborative development services revenue.

    Net loss from operations for the quarter ended September 30, 2021 was $4.2 million, compared with $5.2 million for the same period in 2020. Net loss per share was $(0.60) for the quarter ended September 30, 2021 compared with $(1.12) for the third quarter of 2020.

    Cash, cash equivalents and short-term available-for-sale securities totaled $25.4 million as of September 30, 2021, with current liabilities of approximately $8.1 million and non-current liabilities of $11.5 million.

    Conference Call and Webcast:

    HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

    Date: Wednesday, November 10, 2021
    Time: 4:30 p.m. Eastern Time
    Toll Free: (877) 407-0789
    International: (201) 689-8562
    Conference ID: 13721188
    Webcast: http://public.viavid.com/index.php?id=145556

    About HTG:

    HTG is accelerating precision medicine from diagnosis to treatment by harnessing the power of transcriptome-wide profiling to drive translational research, clinical diagnostics and targeted therapeutics across a variety of disease areas.

    Building on more than a decade of pioneering innovation and partnerships with biopharma leaders and major academic institutes, HTG's proprietary RNA platform technologies are designed to make the development of life science tools and diagnostics more effective and efficient and to unlock a differentiated and disruptive approach to transformative drug discovery. For more information visit www.htgmolecular.com.

    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 expected contributions from EAP collaborators, capabilities of the HTG Transcriptome Panel, the expected performance and benefits of HTG Therapeutics, future revenue opportunities, expected continued growth in product revenue, trends in our core business, and our ability to grow our business. Words such as "designed to," "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 our transcriptome panel and advanced chemical library designs may not provide the benefits that we expect; risks associated with our lack of experience in drug discovery and related collaborations; risks associated with our ability to develop and commercialize our products, including our 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; 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 under the "Risk Factors" heading of our Annual Report on Form 10-K for the year ended December 31, 2020 and our most recently filed quarterly report on Form 10-Q. 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: [email protected]

    -Financial tables follow-



    HTG Molecular Diagnostics, Inc.
    Condensed Consolidated Statements of Operations
    (Unaudited)
                       
      Three Months Ended September 30, Nine Months Ended September 30,
      2021   2020 2021 2020
    Revenue:                  
    Product and product-related services $2,520,410    $1,701,068  $6,029,760  $5,417,731 
    Collaborative development services  —     76,030   —   548,135 
    Total revenue  2,520,410     1,777,098   6,029,760   5,965,866 
                       
    Operating expenses:                  
    Cost of product and product-related services revenue  983,761     940,892   2,740,004   2,931,026 
    Selling, general and administrative  4,232,313     4,752,321   11,995,747   13,683,069 
    Research and development  1,534,818     1,255,416   4,188,219   4,914,467 
    Total operating expenses  6,750,892     6,948,629   18,923,970   21,528,562 
    Operating loss  (4,230,482)    (5,171,531)  (12,894,210)  (15,562,696)
    Other income (expense), net  (258,206)    (238,676)  (774,820)  (482,599)
    Gain on forgiveness of PPP Loan  —     —   1,735,792   — 
    Loss on extinguishment of MidCap Credit Facility and QNAH Convertible Note  —     —   —   (522,394)
    Net loss before income taxes  (4,488,688)    (5,410,207)  (11,933,238)  (16,567,689)
    Provision for income taxes  (1,934)    (1,581)  (20,643)  (12,548)
    Net loss $(4,490,622)   $(5,411,788) $(11,953,881) $(16,580,237)
                       
    Net loss per share, basic and diluted $(0.60)   $(1.12) $(1.78) $(3.68)
    Shares used in computing net loss per share, basic and diluted  7,440,287     4,821,562   6,727,916   4,504,469 
                       
       



    HTG Molecular Diagnostics, Inc. 
    Condensed Consolidated Balance Sheets 
      
             
      September 30,  December 31, 
      2021  2020 
    Assets (Unaudited)     
    Current assets:        
    Cash and cash equivalents $10,229,646  $22,397,812 
    Short-term investments available-for-sale, at fair value  15,187,672   6,298,075 
    Accounts receivable  1,904,534   1,588,767 
    Inventory, net  2,340,766   1,492,126 
    Prepaid expenses and other  2,082,410   1,094,273 
    Total current assets  31,745,028   32,871,053 
             
    Operating lease right-of-use assets  1,444,348   1,009,097 
    Property and equipment, net  1,219,190   1,227,402 
    Other non-current assets  98,828   90,356 
    Total assets $34,507,394  $35,197,908 
             
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $1,145,868  $1,348,762 
    Accrued liabilities  1,609,001   1,459,878 
    Contract liabilities - current  213,462   185,083 
    NuvoGen obligation - current  530,657   512,729 
    Current portion of long-term debt  4,167,107   3,022,139 
    Operating lease liabilities - current  398,313   685,220 
    Other current liabilities  17,558   22,563 
    Total current liabilities  8,081,966   7,236,374 
    NuvoGen obligation - non-current, net of discount  4,072,831   4,479,396 
    Long-term debt, net  6,309,416   8,568,308 
    Operating lease liabilities - non-current  1,055,984   368,682 
    Other non-current liabilities  99,825   60,488 
    Total liabilities  19,620,022   20,713,248 
    Commitments and Contingencies        
    Total stockholders' equity  14,887,372   14,484,660 
    Total liabilities and stockholders' equity $34,507,394  $35,197,908 
             



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