Current Report Filing (8-k)
May 30 2018 - 3:37PM
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):
May 30, 2018
Denali
Therapeutics Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-38311
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46-3872213
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(State or other jurisdiction of
incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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151 Oyster Point Blvd., 2nd Floor
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
(650)
866-8548
(Registrants telephone number, including area code)
Not Applicable
(Former
name or former address, if changed since last reports)
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:
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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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In August 2016, Denali Therapeutics Inc.
(Denali or the Company) entered into a license and collaboration agreement with
F-star
Gamma Limited, a private limited liability company incorporated under the laws of England and
Wales
(F-star
Gamma),
f-star
Biotechnologische Forschungs-und Entwicklungsges m.b.H and
F-star
Biotechnology
Limited (the Collaboration
Agreement). In connection with the entry into the Collaboration Agreement, the Company also purchased an option, referred to as the
buy-out
option, to acquire all
of the outstanding shares of
F-star
Gamma pursuant to a
pre-negotiated
buy-out
option agreement.
On May 30, 2018, the Company exercised such
buy-out
option and entered into a Share Purchase
Agreement (the Purchase
Agreement) with the shareholders of
F-star
Gamma and Shareholder Representative Services LLC, pursuant to which the Company acquired all of the outstanding shares of
F-star
Gamma (the Acquisition).
As a result of the Acquisition,
F-star
Gamma has become a wholly owned subsidiary of the Company and the Company plans to change the entitys name to Denali BBB Holding Limited. In addition, the Company became a direct licensee of certain
intellectual property of
F-star
Biotechnology Limited (by way of the Companys assumption of
F-star
Gammas license agreement with
F-star
Biotechnology Limited, dated August 24, 2016, (the
F-star
Gamma License)). The Company is obligated to make initial exercise payments under the
buy-out
option agreement and the
F-star
Gamma License of, in the aggregate, $18.0 million, less the estimated net liabilities of
F-star
Gamma, which is approximately $0.2 million. In addition, the Company is required under the
buy-out
option agreement and the
F-star
Gamma License to make future contingent payments up to a maximum amount of $447.0 million in the aggregate upon the achievement of certain defined preclinical, clinical, regulatory and commercial
milestones. The amount of the contingent payments varies based on whether
F-star
delivers an Fcab
TM
(constant
Fc-domains
with antigen-binding activity) that meets
pre-defined
criteria and whether the Fcab has been identified solely by the Company or solely by
F-star
or jointly by the Company and
F-star.
In addition,
Denali has expanded certain rights under the existing Collaboration Agreement and has exercised its right to nominate two additional blood-brain barrier (BBB) transporter Fcab
targets.
The Company is obligated to make a
one-time
payment for these expanded rights under the existing Collaboration Agreement of, in the aggregate, $6.0 million.
Under the Collaboration Agreement,
f-star
Biotechnologische Forschungs-und Entwicklungsges m.b.H and
F-star
Biotechnology Limited will continue to be prohibited from developing, commercializing and manufacturing any antibody or other molecule that incorporates any Fcab directed to any of the three BBB transporter
Fcab targets nominated by the Company, or any such Fcab as a standalone product, and from authorizing any third party to take any such action.
The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the Collaboration Agreement and related
buy-out
option agreement, which were previously filed with the Securities and Exchange Commission as Exhibit 10.11 to the Companys Registration Statement on Form
S-1,
as well as the Purchase Agreement and the
F-star
Gamma License, which will be filed as exhibits to the Companys Quarterly Report on Form
10-Q
for the period ending June 30, 2018. Denali also intends to seek confidential treatment of certain terms of the Purchase Agreement and the
F-star
Gamma License at
such time.
Item 2.01
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Completion of Acquisition or Disposition of Assets.
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The information set forth above in
Item 1.01 of this Current Report on Form
8-K
is hereby incorporated by reference into this Item 2.01.
Item 7.01
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Regulation FD Disclosure.
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On May 30, 2018, Denali issued a press release
announcing the Acquisition. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information in the press release shall not be deemed filed for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
SIGNATURE
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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DENALI THERAPEUTICS INC.
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Date: May 30, 2018
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By:
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/s/ Steve E. Krognes
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Steve E. Krognes
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Chief Financial Officer
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