Item 1.01 Entry into a Material Definitive Agreement.
On January 2, 2020, GlycoMimetics, Inc. (the "Company") entered into a
Collaboration and License Agreement (the "Agreement") with Apollomics (Hong
Kong) Limited, a Hong Kong entity ("Apollomics"). Under the terms of the
Agreement, the Company has granted to Apollomics the exclusive right to develop,
manufacture and commercialize the Company's drug candidates uproleselan
(formerly referred to as GMI-1271) and GMI-1687 within the territories of China,
Taiwan, Hong Kong and Macau (referred to collectively as "Greater China"). In
addition, the Company has granted to Apollomics a non-exclusive license to
conduct preclinical research outside of Greater China with respect to the
licensed drug candidates for the purpose of developing them for use in Greater
China. Apollomics will purchase clinical trial supply of uproleselan and
GMI-1687 from the Company, and the parties will also negotiate in good faith to
enter into an agreement for commercial supply prior to any anticipated
commercialization in Greater China. As part of the collaboration, the Company
has also granted to Apollomics a right of first negotiation with respect to
commercialization of the Company's drug candidate GMI-1359 in Greater China.
Uproleselan is designed to block E-selectin, an adhesion molecule on cells in
the bone marrow, from binding with blood cancer cells as a targeted approach to
disrupting well-established mechanisms of leukemic cell resistance within the
bone marrow microenvironment. Uproleselan is currently in a comprehensive,
global Phase 3 development program in acute myeloid leukemia, or AML, and has
received breakthrough therapy designation from the U.S. Food and Drug
Administration, or FDA, for the treatment of adult AML patients with relapsed or
refractory disease. GMI-1687 is an E-selectin antagonist potentially suitable
for subcutaneous administration that is currently undergoing investigational new
drug (IND)-enabling studies in the United States. The Company believes that
GMI-1687 could be developed as a potential life-cycle expansion to broaden the
clinical usefulness of an E-selectin antagonist, such as uproleselan, to
conditions where outpatient treatment is preferred or required.
Under the Agreement, Apollomics will make an upfront payment to the Company of
$9.0 million. In addition to the upfront payment, the Company is entitled to
receive up to an aggregate of (i) $35.0 million upon the achievement of
specified milestones related to the development and regulatory approval of
uproleselan in Greater China, (ii) $40.0 million upon the achievement of
specified milestones related to the development and regulatory approval of
GMI-1687 in Greater China and (iii) $105.0 million upon the achievement of
specified net sales thresholds for all licensed products in Greater China. In
the event that uproleselan or GMI-1687 is approved for marketing in Greater
China, the Company will be entitled to receive royalty payments based on a
tiered percentage of annual net sales in each region within Greater China, with
such percentage ranging from the high single digits to the mid-teens, subject to
reduction in the event of generic competition in a particular region and in
other specified circumstances. Apollomics' obligation to pay royalties will
continue, on a licensed product-by-licensed product basis and region-by-region
basis, for 15 years after the first commercial sale in a particular region
within Greater China or, if later, until the expiration of the last-to-expire
patent covering a given licensed product in a given region.
Under the Agreement, Apollomics will be responsible for the development of the
licensed products at its own cost and expense and shall use commercially
reasonable efforts to develop, obtain and maintain regulatory approval in each
region in Greater China. Apollomics will also contribute, subject to regulatory
approval, a prospective cohort of Chinese patients in parallel with the
Company's ongoing global Phase 3 clinical trial of uproleselan in
relapsed/refractory AML patients. In the event that the Company conducts a
global clinical trial of uproleselan or GMI-1687 for an indication other than
AML, Apollomics will have the option to participate in such global trial and to
share development costs with the Company on the terms set forth in the
Agreement.
During the term of the Agreement, neither party will develop, manufacture, or
commercialize a competing product in Greater China, subject to certain
exclusions and procedures upon the consummation of a change of control of each
party.
The Agreement, once effective, will continue in force on a region-by-region
basis until Apollomics has no remaining royalty obligations in such
region. Either party may terminate the Agreement (i) in the event the other
party shall have materially breached its obligations thereunder and such default
shall have continued for a specified period after written notice thereof or (ii)
upon the bankruptcy of the other party. The Company may terminate the agreement,
upon prior
written notice, (i) if Apollomics discontinues material development or
commercialization activities for at least six months, subject to certain
exceptions, or (ii) if Apollomics challenges the validity, enforceability or
scope of any of the patents licensed by the Company under the Agreement, subject
to certain conditions. In addition, Apollomics may terminate the Agreement (i)
at any time for convenience upon 90 days' written notice to the Company or (ii)
upon prior written notice to the Company if a regulatory authority in Greater
China has ordered Apollomics to cease sales of licensed products due to a safety
concern and Apollomics has used commercially reasonable efforts to resolve such
safety concern for a period of 90 days.
The foregoing summary of the Agreement is not complete and is qualified in its
entirety by reference to the text of the Agreement, a copy of which will be
filed as an exhibit to the Registrant's Annual Report on Form 10-K for the year
ended December 31, 2019.
Item 7.01 Regulation FD Disclosure.
On January 6, 2020, the Company issued a press release announcing its entry into
the Agreement. A copy of this press release is furnished as Exhibit 99.1 to this
Current Report. The information in this Item 7.01, including Exhibit 99.1, is
intended to be furnished and shall not be deemed "filed" for purposes of
Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or
otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933 or the
Exchange Act, except as expressly set forth by specific reference in such
filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number Exhibit Description
99.1 Press Release, dated January 6, 2020, "GlycoMimetics and Apollomics
Announce Exclusive Collaboration and License Agreement to Develop and
Commercialize Uproleselan and GMI-1687 in Greater China."
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