0001564590-18-014087.txt : 20180521 0001564590-18-014087.hdr.sgml : 20180521 20180521164704 ACCESSION NUMBER: 0001564590-18-014087 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20180516 ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20180521 DATE AS OF CHANGE: 20180521 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HTG MOLECULAR DIAGNOSTICS, INC CENTRAL INDEX KEY: 0001169987 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 860912294 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37369 FILM NUMBER: 18850208 BUSINESS ADDRESS: STREET 1: 3430 E. GLOBAL LOOP CITY: TUCSON STATE: AZ ZIP: 85706 BUSINESS PHONE: 877-289-2615 MAIL ADDRESS: STREET 1: 3430 E. GLOBAL LOOP CITY: TUCSON STATE: AZ ZIP: 85706 FORMER COMPANY: FORMER CONFORMED NAME: HTG MOLECULAR DIAGNOSTICS INC DATE OF NAME CHANGE: 20110523 FORMER COMPANY: FORMER CONFORMED NAME: HIGH THROUGHPUT GENOMICS INC DATE OF NAME CHANGE: 20020326 8-K 1 htgm-8k_20180516.htm 8-K SOW ONE htgm-8k_20180516.DOCX.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 16, 2018

 

HTG Molecular Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

 

 

 

 

 

Delaware

 

001-37369

 

86-0912294

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

3430 E. Global Loop

Tucson, AZ

 

85706

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (877) 289-2615

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.


 

Item 1.02Termination of a Material Definitive Agreement.

On May 16, 2018, HTG Molecular Diagnostics, Inc. (the Company) received written notice from QIAGEN Manchester Limited (QIAGEN), a U.K. corporation and wholly owned subsidiary of QIAGEN N.V., that QIAGEN has terminated the first statement of work, dated June 14, 2017, as amended (SOW One) under the Master Assay Development, Commercialization and Manufacturing Agreement (Master Agreement) between the parties.

SOW One relates to the development and use of a next-generation sequencing-based clinical trial assay (the Project) that is the subject of a sponsor project agreement between QIAGEN and a pharmaceutical company (Pharma One). The notice follows the termination of the Project by Pharma One. As a result of the termination of SOW One, the Company will discontinue development activities related to the Project.

SOW One relates to one of three development programs, each for a different pharmaceutical company, announced to date under the Master Agreement. SOW One is the only development program under the Master Agreement affected by the notice of termination.

QIAGEN North American Holdings, Inc., a wholly owned subsidiary of QIAGEN N.V., owns 833,333 shares of the Companys common stock, and holds a subordinated convertible promissory note issued by the Company in the principal amount of $3.0 million.

Item 7.01Regulation FD Disclosure.

The Company was informed that the termination of SOW One is the result of Pharma One’s Project-related phase three drug trial failing to meet its endpoint, and that the termination of SOW One was not attributable to any performance issues associated with the Company’s products or services. It is not uncommon for clinical trials to fail, and the Company accordingly expects that up to 50% of the phase three clinical trials conducted by biopharmaceutical company customers in conjunction with the Master Agreement could fail to meet their endpoints. As a result, the Company expects that its program pipeline under the Master Agreement will continue to be dynamic, including the possible initiation of new biopharma programs and the potential termination of other biopharma programs. The Company reconfirms its previous 2018 revenue guidance of $21.0 to $25.0 million.

 

Safe Harbor Statement:

 

Statements contained in this report 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 Company’s expectations with respect to biopharma programs under the Master Agreement and the Company’s revenue projections and related guidance. 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 the Company may not achieve its revenue expectations for 2018 (including, without limitation, due to variations from expectations in the amount or timing of work it performs under one or more companion diagnostic development programs with large pharma customers, which development programs comprise an increasing portion of the Company’s business and therefore have the ability to significantly impact the timing and amount of revenue recognized in one or more fiscal periods), the risk that the Company may not realize the benefits expected under the Master Agreement, risks associated with the Company’s ability to successfully commercialize its products; and the risk that the Company’s products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all. These and other factors are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including without limitation its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018. All forward-looking statements contained in this report speak only as of the date on which they were made, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Date: May 21, 2018

 

 

 

HTG Molecular Diagnostics, Inc.

 

 

 

 

 

 

 

 

By:

 

/s/ Shaun D. McMeans

 

 

 

 

 

 

Shaun D. McMeans

 

 

 

 

 

 

Senior Vice President and Chief Financial Officer