Current Report Filing (8-k)
June 02 2017 - 5:30PM
Edgar (US Regulatory)
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): June 2, 2017
HTG Molecular Diagnostics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-37369
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86-0912294
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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3430 E. Global Loop
Tucson, AZ
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85706
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(Address of principal executive offices)
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(Zip Code)
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Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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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 1.01
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Entry into a Material Definitive Agreement.
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On June 2, 2017, HTG Molecular Diagnostics, Inc. (the
Company) entered into an Amended and Restated Development and Component Supply Agreement with Illumina, Inc. (Illumina), effective May 31, 2017 (the Restated Agreement), which amends and restates the parties
IVD Test Development and Component Supply Agreement, dated October 15, 2014 (the Original Agreement). The Restated Agreement provides for the development and worldwide commercialization by the Company of nuclease-protection-based RNA or
DNA profiling tests (IVD test kits) for use with Illuminas MiSeqDx sequencer in the field of diagnostic oncology testing in humans (the Field).
Under the Restated Agreement, the parties will continue activities under the First Development Plan which was entered pursuant to the Original Agreement, and
the Company may, at its discretion, submit additional development plans for IVD test kits in the Field to Illumina for its approval, not to be unreasonably withheld. Under each development plan, Illumina would provide specified regulatory support
and rights, and develop and deliver to the Company an executable version of custom software, which, when deployed on Illuminas MiSeqDx sequencer, would enable sequencing by the end-user of the subject IVD test kit probe library. Illumina
retains ownership of the custom software, subject to the Companys right to use the custom software in connection with the commercialization of IVD test kits. The Company is required to pay Illumina up to $0.6 million in the aggregate upon
achievement of specified regulatory milestones relating to the IVD test kits. In addition, the Company has agreed to pay Illumina a single digit percentage royalty on net sales of any IVD test kits that the Company commercializes pursuant to the
Restated Agreement.
Absent earlier termination, the Restated Agreement will expire in May 2027; however, Illumina is no longer obligated to notify the
Company of changes in its products that may affect the Companys IVD test kits after May 31, 2023. The Company may terminate the Restated Agreement at any time upon 90 days written notice and may terminate any development plan under the
Restated Agreement upon 30 days prior written notice. Illumina may terminate the Restated Agreement upon 30 days prior written notice if the Company undergoes certain changes of control, subject to a transition period of up to 12 months
for then-ongoing development plans. Either party may terminate the Restated Agreement upon the other partys material breach of the Restated Agreement that remains uncured for 30 days, or upon the other partys bankruptcy.
As previously reported, on April 13, 2017 the Company entered into a Controlled
Equity Offering
SM
Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as sales agent (Cantor Fitzgerald), pursuant to which the Company may
offer and sell, from time to time, through Cantor Fitzgerald, shares of the Companys common stock, par value $0.001 per share, by any method deemed to be an at the market offering as defined in Rule 415 under the Securities Act of
1933, as amended (the ATM Offering). On April 13, 2017, the Company filed a prospectus supplement (File
No. 333-216977)
with the Securities and Exchange Commission (SEC)
relating to the offer and sale of up to $20,000,000 of common stock in the ATM Offering.
On June 2, 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 under the Sales Agreement to $40,000,000 in the aggregate, inclusive of the 2,468,104 shares of common stock previously sold
in the ATM Offering for gross proceeds of $12.8 million prior to the date of the amendment.
The legal opinion of Cooley LLP relating to the shares
of common stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on
Form 8-K.
This Current Report on
Form 8-K
shall not constitute an offer to sell or the solicitation of an offer to buy any
shares under the Sales Agreement nor shall there be any sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Item 9.01
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Financial Statements and Exhibits
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(d) Exhibits.
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Exhibit
Number
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Description
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5.1
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Opinion of Cooley LLP.
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23.1
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Consent of Cooley LLP (included in Exhibit 5.1).
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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.
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HTG Molecular Diagnostics, Inc.
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Dated: June 2, 2017
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By:
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/s/ Shaun D. McMeans
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Shaun D. McMeans
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Vice President of Finance and Administration and
Chief Financial Officer
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EXHIBIT INDEX
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Exhibit
Number
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Description
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5.1
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Opinion of Cooley LLP.
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23.1
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Consent of Cooley LLP (included in Exhibit 5.1).
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