- Entered into a master companion diagnostic agreement with Merck KGaA, Darmstadt, Germany including an immediate development agreement utilizing the HTG EdgeSeq DLBCL Cell of Origin Assay for the Merck KGaA, Darmstadt, Germany's BTK program M7583. The initial development agreement for the BTK program is a multiyear development program. Upon the achievement of specified development milestones until the launch of the companion diagnostic for the BTK program M7583 -- currently in early Phase I studies -- HTG is eligible to receive up to an estimated $10 million in payments. DLBCL is the most common form of non-Hodgkin's lymphoma representing 25-35% of new cases. The companion diagnostic master agreement also sets the stage for further development programs in the future.
- Completed the first phase of the HTG EdgeSeq ALK Plus Assay clinical trial and expect to file the third module of our Premarket Approval (PMA) application, including the intra lab reproducibility study results with FDA by year end.
- Entered into a distribution agreement for Italy with Gilson Italia SRL, further expanding our commercialization capabilities in Europe. HTG now has direct sales coverage in the UK, France, Germany, Switzerland, Belgium and the Nordic countries and has distribution partnerships in Spain, Portugal, Italy and Israel.
- HTG EdgeSeq technology generated data featured in a late-breaking oral presentation at the Society for Immunotherapy of Cancer (SITC 2016). HTG EdgeSeq Immuno-Oncology Assay (IO) data was presented to provide initial mechanistic-based gene expression assessment of tumor biopsies from patients and preliminary efficacy clinical data from Bristol-Myers Squibb's double IO combination trial studying Lirilumab in combination with Nivolumab for treatment of advanced head and neck squamous cell carcinoma.
Net loss from operations for the three and nine months ended September 30, 2016 was $6.1 million and $19.1 million, respectively, compared with $4.8 million and $13.5 million for the three and nine months ended September 30, 2015, respectively. Net loss per share was $(0.92) and $(2.92) for the three and nine months ended September 30, 2016, respectively, compared with $(0.76) and $(4.56) for the three and nine months ended September 30, 2015, respectively.HTG ended the third quarter with $16.6 million in total cash, cash equivalents and available-for-sale investments. Conference Call and Webcast: HTG will host an investment community conference call today beginning at 4:30 p.m. ET. Individuals interested in listening to the conference call may do so by dialing (866) 394-4225 for domestic callers, or (678) 509-7535 for international callers (conference ID: 9555990), or from the webcast on the "Investors" section of the Company's website at: http://www.htgmolecular.com. The webcast will be available on the Company's website for 90 days following the completion of the call. About HTG:Headquartered in Tucson, Arizona, HTG's mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG's proprietary nuclease protection chemistry. HTG's product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. 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 Merck KGaA master and development program agreements, our ability to commercialize diagnostic products in Europe, our expected filings with the FDA and our planned clinical trials. 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, the risk that we may not realize the benefits expected under our agreements, risks associated with our ability to successfully commercialize our products; performance by our collaborators and other third parties; our ability to manufacture our products to meet demand; the level and availability of first party payor reimbursement for our products; our ability to effectively manage our anticipated growth; 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 first 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 June 30, 2016. 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.
-Financial tables follow-
|HTG Molecular Diagnostics, Inc.|
|Statements of Operations|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Cost of revenue||1,125,009||809,015||2,901,455||2,538,590|
|Selling, general and administrative||3,937,600||3,717,402||13,343,945||10,883,161|
|Research and development||1,910,116||1,309,573||6,515,808||2,951,009|
|Total operating expenses||5,847,716||5,026,975||19,859,753||13,834,170|
|Loss from change in stock warrant valuation||—||—||—||(239,683||)|
|Interest expense, net||(464,629||)||(340,868||)||(1,329,404||)||(1,285,173||)|
|Loss on settlement of convertible debt||—||—||—||(705,217||)|
|Net loss before income taxes||(6,488,442||)||(5,157,663||)||(20,362,210||)||(15,698,139||)|
|Accretion of redeemable convertible preferred stock discount, issuance costs and dividends||—||—||—||(1,328,594||)|
|Net loss attributable to common stockholders||$||(6,488,442||)||$||(5,157,663||)||$||(20,366,469||)||$||(17,026,733||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.92||)||$||(0.76||)||$||(2.92||)||$||(4.56||)|
|Shares used in computing net loss per share attributable to common stockholders, basic and diluted||7,053,010||6,829,687||6,985,924||3,735,852|
|(1) The Company recorded an increase to the inventory allowance of $292,000 to reserve for the remaining value of our Edge reader inventory.|
|HTG Molecular Diagnostics, Inc.|
|September 30,||December 31,|
|Cash and cash equivalents||$||5,523,824||$||3,293,983|
|Short-term investments available-for-sale, at fair value||11,097,140||28,201,507|
|Prepaid expenses and other||441,306||445,217|
|Total current assets||19,521,816||34,858,254|
|Long-term investments available-for-sale, at fair value||—||2,603,901|
|Property and equipment, net||3,666,947||1,932,213|
|Liabilities and stockholders' equity (deficit)|
|Other current liabilities||270,041||29,243|
|Total current liabilities||9,801,121||6,319,610|
|Term loan payable - non-current, net of discount and debt issuance costs||6,902,379||7,737,586|
|NuvoGen obligation - non-current, net of discount||8,169,861||8,415,122|
|Commitments and Contingencies|
|Total stockholders' equity (deficit)||(2,214,757||)||16,893,398|
|Total liabilities and stockholders' equity (deficit)||$||23,188,763||$||39,394,368|
Contact:Westwicke PartnersJamar IsmailPhone: (415) 513-1282Email: email@example.comTJ JohnsonPresident / CEOHTG Molecular DiagnosticsPhone: (520) 547-2827 x130Email: firstname.lastname@example.org