Combined Company Will Operate as Syros
Pharmaceuticals and Continue to Advance Syros’ Ongoing Clinical
Programs
Syros Expects to Have Cash Into 2025; At Least
a Year Past SELECT-MDS-1 Pivotal Data
Now Planning to Initiate Phase 3 Clinical Trial
of SY-2101 in APL 2H 2023
Syros to Host Conference Call at 8:30 AM ET
Today
Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development
of medicines that control the expression of genes, and TYME
Technologies, Inc. (NASDAQ:TYME), today announced that the
companies have entered into a definitive merger agreement pursuant
to which Syros will acquire TYME, including its pipeline assets and
net cash at closing which after accounting for wind-down and
transaction expenses is currently estimated to be approximately $60
million. The combined company will trade on Nasdaq under the ticker
symbol “SYRS” and will be led by Syros’ existing management team,
including Nancy Simonian, M.D., Chief Executive Officer of Syros,
and will remain focused on advancing Syros’ pipeline of small
molecule medicines for the treatment of cancer.
Concurrent with the merger, Syros announced an oversubscribed
$130 million private investment in public equity (PIPE) financing
at a price per unit of $0.94. New and existing investors in the
PIPE which was led by a life sciences-focused investment fund
include Syros co-founder and founding investor Flagship Pioneering,
Avidity Partners, Deep Track Capital, Bain Capital Life Sciences,
Invus, Samsara BioCapital, Adage Capital Partners LP, Ally Bridge
Group and Cowen Healthcare Investments, as well as other investors.
Additionally, Syros stockholders holding approximately 28% of the
outstanding shares of Syros common stock and TYME stockholders
holding approximately 30% of the outstanding shares of TYME common
stock signed support agreements obligating them to vote in favor of
the transactions.
Syros also announced an amendment to its senior secured loan
facility with Oxford Finance LLC which, subject to certain
conditions, will extend the interest-only payment period from March
1, 2023 to March 1, 2024 (and, upon the achievement of certain
milestones, September 1, 2024), and will extend the maturity date
from February 1, 2025 to February 1, 2026 (and, upon the
achievement of certain milestones, August 1, 2026).
Following the closing of the merger, financing and debt
agreement amendment, the total cash balance of the combined company
is expected to be approximately $240 million (after transaction
expenses), sufficient to fund Syros’ planned operating expenses and
capital expenditure requirements into 2025.
“This is a pivotal moment for Syros. We believe these
transactions will bring us the necessary capital to advance our
late-stage clinical programs toward commercialization, including
tamibarotene, currently being studied in the SELECT-MDS-1 trial,
the randomized portion of the SELECT-AML-1 trial, and SY-2101,
which we plan to advance into a Phase 3 trial next year for the
treatment of acute promyelocytic leukemia,” said Dr. Simonian.
“After evaluating safety lead-in data from the SY-5609 Phase 1
trial in pancreatic cancer we will assess the optimal path forward
for this program. Additionally, we have decided to seek
partnerships for our oncology discovery programs. Together, these
decisions allow us to focus on the most advanced programs across
our targeted hematology portfolio where we believe we can more
rapidly address significant unmet needs. We are grateful for our
new and existing investors, as well as to the TYME team for their
spirit of collaboration throughout this process and look forward to
delivering on our vision of bringing forward medicines that
redefine the standard of care for cancer patients.”
“Following an extensive review of numerous strategic
alternatives, it was clear that the proposed merger with Syros was
the best option for our shareholders,” said Richie Cunningham,
Chief Executive Officer of TYME Technologies. “The team at Syros
shares our unwavering commitment to develop medicines that make a
profound difference in patients’ lives. Syros has a robust pipeline
with its lead program in Phase 3, an experienced management and
board, and now is well capitalized to execute on its clinical
endeavors. Additionally, Syros will continue our work of evaluating
the best path forward for the SM–88 program.”
In conjunction with these strategic transactions, Syros provided
an update on the following clinical and discovery programs:
Tamibarotene: Oral RARα Agonist
Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Syros continues to progress the ongoing SELECT-MDS-1 Phase 3
trial in newly diagnosed RARA-positive patients with HR-MDS and
remains on track to report topline data in the fourth quarter of
2023 or the first quarter of 2024, with a potential new drug
application (NDA) filing expected in 2024.
Acute Myeloid Leukemia (AML)
Syros continues to evaluate tamibarotene in combination with
venetoclax and azacitidine in the ongoing SELECT-AML-1 Phase 2
trial in newly diagnosed RARA-positive patients with unfit AML.
Syros expects to report clinical activity and safety data from the
safety lead-in portion of the study in second half of 2022. Syros
also plans to initiate the randomized portion of the trial in an
additional eighty RARA-positive unfit AML patients, evaluating the
triplet regimen of tamibarotene, venetoclax and azacitidine versus
venetoclax and azacitidine with data expected in 2023 or 2024.
SY-2101: Oral Arsenic Trioxide
Syros is advancing the ongoing dose confirmation trial of
SY-2101 in patients with newly diagnosed acute promyelocytic
leukemia (APL) and expects to announce pharmacokinetic and safety
data in mid-2022. Syros now expects to initiate a Phase 3 clinical
trial of SY-2101 in the second half of 2023.
SY-5609: Oral Selective CDK7 Inhibitor
Syros is evaluating SY-5609 in combination with chemotherapy in
relapsed/refractory metastatic pancreatic cancer patients. The
company expects to report safety and clinical activity data from
the safety lead-in portion of the trial in the second half of 2022.
Based on the safety lead-in data, Syros will determine the best
course for further development of SY-5609.
In addition, the arm of Roche’s ongoing Phase 1/1b INTRINSIC
trial evaluating SY-5609 in combination with atezolizumab, it’s
PD-L1 inhibitor, in BRAF-mutant colorectal cancer is now open for
enrollment. Under the terms of Syros’ agreement with Roche, Roche
is the sponsor of the trial and Syros is supplying SY-5609.
Gene Control Discovery Engine
Syros is seeking partnerships for its discovery programs,
including its CDK12 program. Syros remains on track to nominate a
development candidate from its CDK12 program in the third quarter
of 2022.
Syros will continue to execute on its existing collaborations
with Incyte Corporation and Global Blood Therapeutics, for which
its research efforts are fully funded externally, as provided in
each agreement.
Transaction Details
In the merger, Syros expects to issue approximately 74.3 million
shares of its common stock to TYME stockholders to acquire TYME’s
expected net cash at closing and TYME stockholders are expected to
receive approximately 0.4312 shares of Syros common stock for each
share of TYME common stock. The actual number of shares to be
issued in the merger and the exchange ratio will be subject to
adjustment based on the amount of TYME’s net cash at closing and
the number of TYME shares outstanding at closing. Upon closing of
the merger, TYME will become a wholly owned subsidiary of Syros.
The merger agreement has been approved by the Board of Directors of
each company.
In the PIPE financing, Syros agreed to sell units comprising (i)
an aggregate of 138.1 million shares of its common stock and
pre-funded warrants to purchase shares of common stock and (ii)
accompanying warrants to purchase an aggregate of up to 138.1
million additional shares of common stock (or pre-funded warrants
in lieu thereof), at a price per unit of $0.94 (or $0.9399 per unit
comprising a pre-funded warrant and accompanying warrant). The
exercise price of the warrants is $1.034 per share, or if exercised
for a pre-funded warrant in lieu thereof, $1.0399 per pre-funded
warrant (representing the warrant exercise price of $1.034 per
share minus the $0.0001 per share exercise price of each such
pre-funded warrant).
The warrants are exercisable at any time during the period
beginning six months after the closing of the PIPE financing and
ending five years after such closing. The pre-funded warrants are
exercisable at any time after their original issuance and will not
expire. The expected gross proceeds from the PIPE financing are
$130 million, before deducting estimated offering expenses.
The merger, together with the PIPE financing, is intended to be
tax free for U.S. federal income tax purposes to TYME
stockholders.
The number of shares of Syros common stock issuable in the PIPE
financing and the merger are subject to adjustment in the event of
any reverse stock split that may be effectuated by Syros in
connection with the transactions.
The transactions are expected to close in the second half of
2022 concurrently with each other, subject to approval by the
stockholders of Syros and TYME, the effectiveness of a registration
statement to be filed with the U.S. Securities and Exchange
Commission (the ”SEC”) to register the shares of Syros common stock
to be issued in connection with the merger and the satisfaction of
other customary closing conditions.
Net proceeds from the merger and the PIPE financing are expected
to be used to advance Syros’ clinical development pipeline,
business development activities, working capital and other general
corporate purposes.
The securities to be sold in the PIPE have not been registered
under the Securities Act of 1933, as amended (“Securities Act”), or
any state or other applicable jurisdiction’s securities laws, and
may not be offered or sold in the United States absent registration
or an applicable exemption from the registration requirements of
the Securities Act and applicable state or other jurisdictions’
securities laws.
Management and Organization
Effective as of the closing of the transactions, the Syros
leadership team will continue to be responsible for all executive
positions of the combined company. Nancy Simonian, M.D., will be
the Chief Executive Officer, David A. Roth, M.D., will serve as
Chief Medical Officer, Kristin Stephens will serve as Chief
Development Officer, Eric Olson, Ph.D., will serve as Chief
Scientific Officer, Jason Haas will serve as Chief Financial
Officer and Conley Chee will serve as Chief Commercial Officer.
Additionally, effective as of the closing of the transactions,
Syros expects to add a board member nominated by TYME and a board
member nominated by a PIPE investor.
Advisors
Piper Sandler & Co. is acting as financial advisor to Syros.
Moelis & Company LLC is acting as financial advisor to TYME.
Cowen and Piper are acting as placement agents for the PIPE
transaction. WilmerHale LLP is acting as legal counsel to Syros.
Faegre Drinker Biddle & Reath LLP is acting as legal counsel to
TYME.
Conference Call Information
Syros will host a conference call today, July 5, 2022 at 8:30
a.m. ET, to discuss the transactions. Participants may register for
the conference call here. While not required, it is recommended
that participants join the call ten minutes prior to the scheduled
start.
A live webcast of the call will also be available on the
Investors & Media section of the Syros website at
http://ir.syros.com.
About Syros Pharmaceuticals
Syros is redefining the power of small molecules to control the
expression of genes. Based on its unique ability to elucidate
regulatory regions of the genome, Syros aims to develop medicines
that provide a profound benefit for patients with diseases that
have eluded other genomics-based approaches. Syros is advancing a
robust clinical-stage pipeline, including: tamibarotene, a
first-in-class oral selective RARα agonist in RARA-positive
patients with higher-risk myelodysplastic syndrome and acute
myeloid leukemia; SY-2101, a novel oral form of arsenic trioxide in
patients with acute promyelocytic leukemia; and SY-5609, a highly
selective and potent oral CDK7 inhibitor in patients with select
solid tumors. Syros also has multiple preclinical and discovery
programs in oncology and monogenic diseases. For more information,
visit www.syros.com and follow us on Twitter (@SyrosPharma) and
LinkedIn.
About TYME Technologies, Inc.
TYME is an emerging biotechnology company developing cancer
metabolism-based therapies (CMBTs™) that are intended to be
effective across a broad range of solid tumors and hematologic
cancers, while also maintaining patients’ quality of life through
relatively low toxicity profiles. Unlike targeted therapies that
attempt to regulate specific mutations within cancer, TYME’s
therapeutic approach is designed to take advantage of a cancer
cell’s innate metabolic weaknesses to cause cancer cell death.
The Company is currently focused on developing its novel
compound, SM-88 and its preclinical pipeline of novel CMBT™
programs. TYME believes that early clinical results demonstrated by
SM-88 in multiple advanced cancers, including prostate, sarcomas
and breast, reinforce the potential of its emerging CMBT™
pipeline.
Forward Looking Statements
This press release contains forward-looking statements
(including within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act concerning Syros, TYME, the proposed transactions and other
matters. These statements may discuss goals, intentions and
expectations as to future plans, trends, events, results of
operations or financial condition, or otherwise, based on current
beliefs of the management of Syros and TYME, as well as assumptions
made by, and information currently available to, management of
Syros and TYME. Forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as “may,”
“will,” “should,” “would,” “expect,” “anticipate,” “plan,”
“likely,” “believe,” “estimate,” “project,” “intend,” and other
similar expressions. Statements that are not historical facts are
forward-looking statements. Forward-looking statements are based on
current beliefs and assumptions that are subject to risks and
uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including, without limitation: the risk that the conditions to the
closing of the proposed transactions are not satisfied, including
the failure to obtain stockholder approval for the transactions or
to complete the PIPE financing in a timely manner or at all;
uncertainties as to the timing of the consummation of the
transactions and the ability of each of Syros and TYME to
consummate the transaction, including the PIPE financing; risks
related to TYME’s continued listing on the Nasdaq Stock Market
until closing of the proposed transactions; risks related to Syros’
and TYME’s ability to correctly estimate their respective operating
expenses and expenses associated with the transactions, as well as
uncertainties regarding the impact any delay in the closing would
have on the anticipated cash resources of the combined company upon
closing and other events and unanticipated spending and costs that
could reduce the combined company’s cash resources; the ability of
Syros or TYME to protect their respective intellectual property
rights; competitive responses to the transaction; unexpected costs,
charges or expenses resulting from the transaction; potential
adverse reactions or changes to business relationships resulting
from the announcement or completion of the transaction; and
legislative, regulatory, political and economic developments. The
foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in Syros’ Annual Report on Form 10-K for the year ended
December 31, 2021, Syros’ Quarterly Report on Form 10-Q for the
quarter ended March 31, 2022 and TYME’s Annual Report on Form 10-K
for the year ended March 31, 2022, each of which is on file with
the SEC. In addition, the extent to which the COVID-19 pandemic
continues to impact the proposed transactions will depend on future
developments, which are highly uncertain and cannot be predicted
with confidence, including the duration and severity of the
pandemic, additional or modified government actions, and the
actions that may be required to contain the virus or treat its
impact. Syros and TYME can give no assurance that the conditions to
the transactions will be satisfied. Except as required by
applicable law, Syros and TYME undertake no obligation to revise or
update any forward-looking statement, or to make any other
forward-looking statements, whether as a result of new information,
future events or otherwise.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
No Offer or Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed business combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
any securities nor shall there be any sale of securities in any
state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act.
Important Additional Information Will Be Filed with the
SEC
Syros plans to file with the SEC a Registration Statement on
Form S‑4 in connection with the transactions and Syros and TYME
plan to file with the SEC and mail to their respective stockholders
a Joint Proxy Statement/Prospectus in connection with the
transactions. Investors and security holders are urged to read the
Registration Statement and the Joint Proxy Statement/Prospectus
carefully when they are available before making any voting or
investment decision with respect to the proposed transactions. The
Registration Statement and the Joint Proxy Statement/Prospectus
will contain important information about Syros, TYME, the
transactions and related matters. Investors and security holders
will be able to obtain free copies of the Registration Statement
and the Joint Proxy Statement/Prospectus and other documents filed
with the SEC by Syros and TYME through the web site maintained by
the SEC at www.sec.gov. In addition, investors and security holders
will be able to obtain free copies of the Registration Statement
and the Joint Proxy Statement/Prospectus from Syros by contacting
hannahd@sternir.com or from TYME by contacting
investorrelations@tymeinc.com.
Participants in the Solicitation
Syros and TYME, and their respective directors and executive
officers, may be deemed to be participants in the solicitation of
proxies in respect of the transactions contemplated by the merger
agreement. Information regarding Syros’ directors and executive
officers is contained in Syros’ proxy statement dated April 21,
2022, which is filed with the SEC. Information regarding TYME’s
directors and executive officers is contained in TYME’s proxy
statement dated July 12, 2021, which is filed with the SEC. A more
complete description will be available in the Registration
Statement and the Joint Proxy Statement/Prospectus.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220705005194/en/
Syros Pharmaceuticals’ Media: Courtney Solberg Syros
Pharmaceuticals 917-698-9253 csolberg@syros.com
Syros Pharmaceuticals’ Investors: Hannah Deresiewicz
Stern Investor Relations, Inc. 212-362-1200
hannah.deresiewicz@sternir.com
TYME Technologies’ Investors: Lisa M. Wilson In-Site
Communications, Inc. 212-452-2793 lwilson@insitecony.com
Tyme Technologies (NASDAQ:TYME)
과거 데이터 주식 차트
부터 2월(2) 2025 으로 3월(3) 2025
Tyme Technologies (NASDAQ:TYME)
과거 데이터 주식 차트
부터 3월(3) 2024 으로 3월(3) 2025
