Item 1.01 Entry into a Material Definitive Agreement.
As previously reported, Syros Pharmaceuticals, Inc. (the "Company") is party to
an Amended and Restated Cancer License Agreement (the "1425 License Agreement")
with TMRC Co., Ltd. ("TMRC"), pursuant to which TMRC granted the Company an
exclusive license, with the right to sublicenses, under patent rights, data,
regulatory filings, and other intellectual property controlled by TMRC related
to the development or commercialization of SY-1425 (tamibarotene) for human
cancer indications in North America and Europe. On January 8, 2021, the Company
amended the 1425 License Agreement (the "1425 License Agreement Amendment") to
expand the territory under which the Company is licensed to include Central and
South America, Australia, Israel and Russia. No additional consideration is due
to TMRC in connection with this amendment, other than the obligation to pay
royalties on net sales in those territories on the terms previously set forth in
the 1425 License Agreement.
The foregoing description of the terms of the 1425 License Agreement Amendment
does not purport to be complete and is subject to, and is qualified in its
entirety by, reference to the 1425 License Agreement Amendment, which the
Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for
the fiscal quarter ending March 31, 2021.
Item 2.02 Results of Operations and Financial Condition.
Although it has not finalized its full financial results for the fourth quarter
and fiscal year ended December 31, 2020, the Company announced in a press
release on January 11, 2021, that it expects to report that it had approximately
$174 million of cash, cash equivalents and marketable securities as of
December 31, 2020. A copy of the press release is attached hereto as Exhibit
99.1 and is incorporated herein by reference.
The information contained in Item 2.02 of this Form 8-K and in Exhibit 99.1
regarding the Company's unaudited cash balance as of December 31, 2020 is
unaudited and preliminary and does not present all information necessary for an
understanding of the Company's financial condition as of December 31, 2020 and
its results of operations for the three months and year ended December 31, 2020.
The audit of the Company's consolidated financial statements for the year ended
December 31, 2020 is ongoing and could result in changes to the information set
forth above.
The information in this Item 2.02 and in Exhibit 99.1 regarding the Company's
unaudited cash balance as of December 31, 2020 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 in any filing under the Securities
Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as
expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
Press Release
On January 11, 2021, the Company issued a press release announcing its 2021
business objectives. The full text of this press release is filed as
Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by
reference (in each case, excluding the information regarding the Company's
unaudited cash balance as of December 31, 2020, which is furnished pursuant to
Item 2.02 above). The information contained on the websites referenced in the
press release is not incorporated herein.
Biomarker License Agreement
The Company has developed its own patent portfolio related to SY-1425, which
generally discloses methods of identifying and treating patients wo are
sensitive to RAR? agonists, including SY-1425, based on the expression of
certain biomarkers, including RARA. On January 8, 2021, the
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Company entered into a license agreement (the "Biomarker License Agreement")
with TMRC under which the Company granted TMRC an exclusive license, with the
right to grant sublicenses, under these patent rights and certain know-how that
it controls related to the RARA biomarker for the development and
commercialization of SY-1425 for human cancer indications in Japan, China, South
Korea, India and Taiwan (the "TMRC Territory"). Under the Biomarker License
Agreement, TMRC will be obligated to pay the Company a low single-digit royalty
on net sales of SY-1425 in the TMRC Territory during a pre-specified royalty
term to the extent the manufacture, use or sale of SY-1425 infringes a valid
claim of the patent rights or is developed using know-how licensed to TMRC under
the Biomarker License Agreement.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995, including without limitation
statements regarding the Company's development plans with respect to its drug
candidates, the timing of anticipated data readouts from its clinical trials,
the timing of nomination of the Company's next development candidate, the
Company's estimates regarding its balance of cash, cash equivalents and
marketable securities for the year ended December 31, 2020, and the sufficiency
of the Company's capital resources to fund its anticipated operating expenses
and capital expenditure requirements into the second half of 2022. The words
"anticipate," "believe," "continue," "could," "estimate," "expect," "intend,"
"may," "plan," "potential," "predict," "project," "target," "should," "would,"
and similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying words.
Actual results or events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a result of
various important factors, including the Company's ability to advance the
development of its programs, including SY-1425, SY-5609 and SY-2101, under the
timelines it projects in current and future clinical trials; demonstrate in any
current and future clinical trials the requisite safety, efficacy and
combinability of its drug candidates; replicate scientific and non-clinical data
in clinical trials; successfully develop a companion diagnostic test to identify
patients with the RARA biomarker; obtain and maintain patent protection for its
drug candidates and the freedom to operate under third party intellectual
property; obtain and maintain necessary regulatory approvals; identify, enter
into and maintain collaboration agreements with third parties, including its
ability to perform under its collaboration agreements with Incyte Corporation
and Global Blood Therapeutics; manage competition; manage expenses; raise the
substantial additional capital needed to achieve its business objectives;
attract and retain qualified personnel; and successfully execute on its business
strategies; risks described under the caption "Risk Factors" in the Company's
Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2020, each of which is
on file with the SEC; and risks described in other filings that the Company
makes with the SEC in the future. In addition, the extent to which the COVID-19
outbreak continues to impact the Company's workforce and discovery research,
supply chain and clinical trial operations activities, and the operations of the
third parties on which the Company relies, will depend on future developments,
which are highly uncertain and cannot be predicted with confidence, including
the duration and severity of the outbreak, additional or modified government
actions, and the actions that may be required to contain the virus or treat its
impact. Any forward-looking statements contained in this Form 8-K speak only as
of the date hereof, and the Company expressly disclaims any obligation to update
any forward-looking statements, whether because of new information, future
events or otherwise.
Item 9.01 Financial Statements and Exhibits.
Exhibit
No. Description
99.1 Press Release, dated January 11, 2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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