Current Report Filing (8-k)
July 15 2019 - 3:06PM
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
July 15, 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.
¨
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Item 1.01.
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Entry into a Material
Definitive Agreement.
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On July 15, 2019, Aevi
Genomic Medicine, Inc. (the “
Company
”) entered into an Exclusive License Agreement (“
License Agreement
”)
with OSI Pharmaceuticals, LLC, an indirect wholly-owned subsidiary of Astellas Pharma Inc. (“
Astellas
”) for
the worldwide development and commercialization of Astellas’ second generation mTORC1/2 inhibitor, ASP7486 (OSI-027).
Under the terms of
the License Agreement, the Company will pay Astellas an up-front license fee of $500,000 and Astellas will be eligible to receive
mid-single digit millions in milestone payments based upon the achievement of specified development and regulatory milestones.
Upon commercialization, Astellas will be entitled to a tiered, single-digit royalty on worldwide annual net sales. Pursuant to
the terms of the License Agreement the Company will be responsible for all clinical development, manufacturing, and commercialization
activities and costs. 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 June 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.
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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: July 15, 2019
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