Current Report Filing (8-k)
December 22 2020 - 5:16PM
Edgar (US Regulatory)
0001722964
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0001722964
2020-12-17
2020-12-17
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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):December 22, 2020 (December 17, 2020)
Y-MABS THERAPEUTICS, INC.
(Exact name of registrant as specified
in its charter)
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Delaware
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001-38650
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47-4619612
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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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230 Park Avenue
Suite 3350
New York, New York 10169
(Address of principal executive offices)
(Zip Code)
(646) 885-8505
(Registrant’s telephone number,
include area code)
N/A
(Former Name or Former Address, if Changed
Since Last Report)
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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¨
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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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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 x
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.
Securities registered pursuant to Section 12(b) of
the Act:
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Title of each class:
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Trading Symbol
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Name of each exchange on which registered:
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Common Stock, $0.0001 par value
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YMAB
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NASDAQ Global Select Market
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Item 1.01 Entry into a Material Definitive Agreement.
On December 17, 2020, Y-mAbs Therapeutics,
Inc., (the “Company”) entered into a license agreement (the “License Agreement”) with SciClone
Pharmaceuticals International Ltd. (“SciClone”).
Under the terms of the License Agreement
the Company granted SciClone an exclusive license to develop and commercialize DANYELZA® (naxitamab-gqgk) for the treatment
of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, (jointly “Licensed Products”)
for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, as well as certain other indications,
in Greater China, including Mainland China, Taiwan, Hong Kong and Macau (together the “Territory” and each a
“Region”).
The Company
also agreed to transfer certain know-how including data and regulatory materials related to the Licensed Products and to allow
SciClone the right to access and cross-reference filings made by Y-mAbs regulatory authorities and regulatory materials relating
to the extent necessary in connection with SciClone’s regulatory activities with respect to the Licensed Products.
SciClone has agreed to use its commercially
reasonable efforts to develop and commercialize the Licensed Products through the term of the License Agreement in all Regions
of the Territory.
In
connection with the execution of the License Agreement, SciClone will make an upfront cash payment to the Company of $20 million.
SciClone is obligated to make additional payments of up to $100 million to the Company based on achievement of specified development,
regulatory and sales-related milestones relating to the Licensed products. SciClone is also required to make double-digit royalties
on net sales of Licensed Products in the Territory.
Under
the License Agreement SciClone has agreed to purchase exclusively from the Company and the Company has agreed to provide to SciClone,
necessary supplies of DANYELZA and omburtamab.
The
License Agreement continues in force until terminated by either party on a Licensed Product-by-Licensed Product and Region-by-Region
basis. Each Party may terminate the License Agreement if the other Party materially breaches the License Agreement and does not
cure such breach within a specified period or if a Party experiences certain insolvency events. Each of the Parties also has certain
unilateral termination rights, including a right for SciClone to terminate the License Agreement for convenience.
The License Agreement contains customary
representations, warranties, covenants, and indemnification provisions subject to certain limitations.
The foregoing description of the License
Agreement is not complete and is qualified in its entirety by reference to the text of the License Agreement, a copy of which is
attached hereto as Exhibit 10.1 and incorporated herein by reference.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
* Certain confidential portions of this Exhibit
were omitted by means of marking such portions with brackets (“[***]”) because the
identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly
disclosed.
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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Y-MABS THERAPEUTICS, INC.
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Date: December 22, 2020
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By:
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/s/ Thomas Gad
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Thomas Gad
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Founder, Chairman, President and Head of Business Development and Head of Strategy
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