Current Report Filing (8-k)
07 August 2019 - 10:06PM
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
August 6, 2019
Date of Report (Date of earliest event reported)
AEVI GENOMIC
MEDICINE, INC.
(Exact name of registrant as specified in its charter)
Delaware
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1-35112
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98-0217544
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(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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435 Devon Park Drive, Suite 715
Wayne, Pennsylvania 19087
(Address of principal executive offices,
zip code)
(610) 254-4201
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of exchange on which registered
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Common stock, par value $0.0001 per share
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GNMX
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Nasdaq Global Market
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2. below):
¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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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 August 6, 2019,
Aevi Genomic Medicine, Inc. (the “
Company
”) entered into an Option and License Agreement (“
License
Agreement
”) with MedImmune Limited, a subsidiary of AstraZeneca (“
AZ
”), for the option to exercise
an exclusive global license for MEDI2338, a Phase-2 ready fully human monoclonal antibody that targets interleukin 18.
Under the terms of
the License Agreement, the Company has the right, for up to five months from the agreement effective date, to exercise an option
to enter into an exclusive global license to develop and commercialize MEDI2338 (the “
Option
”). The exercise
of the Option is contingent upon the Company securing additional funding. Upon exercise of the Option, the Company will pay a mid-single
digit millions upfront fee in in a combination of cash and shares of Company common stock. After the Option is exercised, the Company
will be obligated to pay milestone payments upon achievement of certain development and sales-related milestones and tiered low
double-digit royalties on global annual product sales. Pursuant to the terms of the License Agreement, the Company will be responsible
for all clinical development, manufacturing, and commercialization activities and costs. Pursuant to the License Agreement the
Company has agreed to file a resale registration statement covering the shares of its common stock issuable upon exercise of the
Option no later than thirty days following the issuance of such shares. The License Agreement contains customary representations
and warranties, covenants and indemnifications.
The foregoing description
of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the
License Agreement, a copy of which the Company expects to file as an exhibit to the Company’s Quarterly Report on Form 10-Q
for the quarter ending September 30, 2019, portions of which will be subject to a confidential treatment request to the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
A copy of the press
release issued by the Company in connection with the License Agreement is included as Exhibit 99.1 hereto.
Item 3.02.
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Unregistered Sales of Equity Securities.
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The information regarding
the License Agreement and the potential issuance of shares of the Company’s common stock included under Item 1.01 of this
Current Report on Form 8-K is incorporated herein by reference. At the time of issuance, the shares of Company common stock issued
in connection with the exercise of the Option will not be registered under the Securities Act of 1933, as amended (the “Securities
Act”), or the securities laws of any state, and will be issued in reliance on the exemption from registration under the Securities
Act provided by Section 4(a)(2) and Regulation D (Rule 506) under the Securities Act. AZ represented that it was an accredited
investor (as defined by Rule 501 under the Securities Act).
On August 7,
2019, the Company updated and released presentation materials it plans to use in meetings with investors and analysts. A copy
of this presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits.
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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AEVI GENOMIC MEDICINE, INC.
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By:
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/s/ Michael F. Cola
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Name: Michael F. Cola
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Title: President and Chief Executive Officer
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Date: August 7, 2019
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