HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Files An 8-K Entry into a Material Definitive Agreement
Item1.01
| Entry into a Material Definitive Agreement. |
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 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 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.
| Item8.01 | Other Events. |
As previously reported, on April13, 2017 the Company entered into
a Controlled Equity OfferingSMSales Agreement (the Sales
Agreement) with Cantor Fitzgerald Co., as sales agent (Cantor
Fitzgerald), 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
April13, 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 June2, 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 $12.8million prior to the date of
the amendment.
The legal opinion of Cooley LLP relating to the shares of common
stock being offered to the Sales Agreement is filed as Exhibit5.1
to this Current Report on Form8-K.
This Current Report on Form8-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.
| Item9.01 | Financial Statements and Exhibits |
(d) Exhibits.
|
Exhibit Number |
Description |
|
| 5.1 | Opinion of Cooley LLP. | |
| 23.1 | Consent of Cooley LLP (included in Exhibit 5.1). |
About HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM)
HTG Molecular Diagnostics, Inc. is a commercial-stage company that develops and markets a technology platform to facilitate the routine use of complex molecular profiling. The Company’s HTG Edge and HTG EdgeSeq platforms, consisting of instrumentation, consumables and software analytics, are used in sample profiling applications, including tumor profiling, molecular diagnostic testing and biomarker development. The Company’s HTG Edge and HTG EdgeSeq platforms automate the molecular profiling of genes and gene activity using its nuclease protection chemistry on a range of biological samples. The Company’s HTG EdgeSeq chemistry, together with its HTG Edge or HTG EdgeSeq instrumentation and software, automates and adapts its nuclease protection chemistry to enable analysis using next generation sequencing (NGS) instrumentation. The HTG EdgeSeq system utilizes substantially the same sample preparation reagents as its original chemistry, but allows for read out on an NGS instrument. HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Recent Trading Information
HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) closed its last trading session down -0.22 at 3.69 with 657,602 shares trading hands.