Preliminary Data From First Cross-Over Study
Directly Comparing PK of SY-2101 to the Approved IV Dose of ATO
Demonstrates Comparable PK Exposures; Expect to Initiate Phase 3
Clinical Trial of SY-2101 in APL 2H 2023
Definitive Merger Agreement with TYME
Technologies and Concurrent PIPE Expected to Close 2H 2022 and
Bring Combined Proceeds of Approximately $190 Million, Extending
Cash Runway into 2025
On Track to Report Data from Safety Lead-ins of
the SELECT-AML-1 Trial and the Phase 1 SY-5609 Trial in Pancreatic
Cancer in 2H 2022
Advanced SY-12882, an Oral, Potent, and
Selective CDK12 Inhibitor, to Development Candidate
Management to Host Conference Call at 8:30 a.m.
ET Today
Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development
of medicines that control the expression of genes, today reported
financial results for the quarter ended June 30, 2022 and provided
a corporate update.
“We are entering the second half of the year in a position of
strength with multiple data readouts expected over the next 18
months and, following the anticipated closing of our previously
announced merger with TYME Technologies and concurrent PIPE
financing, we expect to have a robust balance sheet,” said Nancy
Simonian, M.D., Chief Executive Officer of Syros. “The gross
proceeds of approximately $190 million from these transactions,
together with the amendment to our existing loan facility, are
expected to extend our cash runway into 2025, at least one year
beyond expected pivotal data from our ongoing SELECT-MDS-1
trial.”
Dr. Simonian continued, “Today, we reported promising
preliminary data from our ongoing dose confirmation trial of
SY-2101, our novel oral form of arsenic trioxide. Based on the
pharmacokinetic data available to date, SY-2101 achieved exposures
comparable to IV arsenic trioxide and demonstrated high oral
bioavailability. The totality of data with our oral arsenic
trioxide continues to support a favorable safety and tolerability
profile, giving us further confidence that SY-2101 has the
potential to replace the standard-of-care for acute promyelocytic
leukemia patients. Based on recent feedback received from the EMA,
Syros plans to conduct a singular registration trial for SY-2101
that could support approval in both the United States and the
European Union.”
UPCOMING MILESTONES
Tamibarotene: Oral RARα agonist
Higher-Risk Myelodysplastic Syndrome (HR-MDS)
- On track to report pivotal data from the SELECT-MDS-1 trial in
newly diagnosed RARA-positive patients with HR-MDS in the fourth
quarter of 2023 or the first quarter of 2024, with a potential new
drug application (NDA) filing expected in 2024.
Acute Myelodysplastic Syndrome (AML)
- On track to report safety and clinical activity data from the
safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial in
RARA-positive patients with newly diagnosed unfit AML in the second
half of 2022.
- Expect to initiate the randomized portion of the SELECT-AML-1
Phase 2 trial in an additional eighty patients evaluating the
triplet regimen of tamibarotene, venetoclax and azacitidine
compared to venetoclax and azacitidine with data expected in 2023
or 2024.
SY-2101: Oral arsenic trioxide (ATO)
- Expect to initiate the Phase 3 trial of SY-2101 for the
treatment of acute promyelocytic leukemia (APL) in the second half
of 2023.
SY-5609: Oral selective CDK7 inhibitor
- On track to report safety and clinical activity data from the
safety lead-in portion of the ongoing Phase 1 trial evaluating
SY-5609 in combination with chemotherapy in relapsed/refractory
metastatic pancreatic cancer in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS
- Today, Syros announced promising preliminary data from newly
diagnosed APL patients enrolled to date in the dose confirmation
trial of SY-2101. This is the first cross-over data directly
comparing the pharmacokinetics (PK) of SY-2101 to the approved IV
dose ATO. SY-2101 administered at 15 mg achieved comparable PK (AUC
and Cmax) exposures to IV ATO administered at 0.15 mg/kg.
Additionally, SY-2101 showed high oral bioavailability of
approximately 80% and continues to support a favorable tolerability
profile.
- In July, Syros received European Medicines Agency (EMA)/
Committee for Medicinal Products for Human Use (CHMP) scientific
advice on the SY-2101 Phase 3 trial design in front line APL. The
feedback informs Syros’ plan for a singular registration trial for
SY-2101 that could support approval in both the United States (US)
and the European Union (EU).
- In July, the EMA issued a positive opinion on the Company’s
application for orphan drug designation for tamibarotene for the
treatment of MDS. The EMA’s orphan designation is available to
companies developing treatments for life-threatening or chronically
debilitating conditions that affect fewer than five in 10,000
persons in the EU. Medicines that meet the EMA’s orphan designation
criteria qualify for financial and regulatory incentives, including
a 10-year period of marketing exclusivity in the EU after product
approval, protocol assistance from the EMA at reduced fees during
the product development phase and access to centralized marketing
authorization.
- In June, Syros announced that based on results from over 175
MDS patients, the company now estimates that approximately 50% of
patients with MDS are RARA-positive, as compared to the previously
estimated 30%.
- Roche is now actively enrolling patients in the arm of its
ongoing Phase 1/1b INTRINISIC trial evaluating SY-5609 in
combination with atezolizumab, its PD-L1 inhibitor, in BRAF-mutant
colorectal cancer patients. Under the terms of Syros’ agreement
with Roche, Roche is the sponsor of the trial and Syros is
supplying SY-5609.
- In July, Syros advanced its oral, potent, and selective CDK12
inhibitor, SY-12882, to development candidate. Preclinical data
presented at the American Association for Cancer Research (AACR)
annual meeting demonstrated that selective CDK12 inhibition
resulted in strong anti-tumor activity as a single agent as well as
in combination with a DNA damaging agent and in combination with a
poly adenosine diphosphate-ribose polymerase (PARP) inhibitor in
models of breast, lung, and ovarian cancer.
CORPORATE
- In July, Syros announced that it plans to raise approximately
$190 million through a merger with TYME Technologies and an
oversubscribed private investment in public equity (PIPE)
financing. The $130M PIPE was led by a life sciences-focused
investment fund, with participation from new and existing
investors, including Syros co-founder and founding investor
Flagship Pioneering, as well as Avidity Partners, Deep Track
Capital, Bain Capital Life Sciences, Invus, Samsara BioCapital,
Adage Capital Partners LP, Ally Bridge Group and Cowen Healthcare
Investments. The transactions are expected to close concurrently
with each other in the second half of 2022, subject to approval by
the stockholders of Syros and TYME and the satisfaction of other
customary closing conditions.
- Concurrently, Syros amended its senior secured loan facility
with Oxford Finance LLC (Oxford) to, subject to certain conditions,
extend the interest-only payment period to March 1, 2024 (and, upon
the achievement of certain milestones, September 1, 2024), and
extend the maturity date to February 1, 2026 (and, upon the
achievement of certain milestones, August 1, 2026).
- Also in July, Syros announced that it is seeking partnerships
for all its wholly owned discovery programs. The Company will
continue to execute on its existing collaborations with Incyte
Corporation (Incyte) and Global Blood Therapeutics (GBT), for which
its research efforts are fully funded, as provided in each
agreement.
Second Quarter 2022 Financial Results
- Revenues were $6.3 million for the second quarter of 2022,
consisting of $5.7 million in revenue recognized under Syros’
collaboration with GBT and $0.6 million recognized under its
collaboration with Incyte. Syros recognized $5.2 million in revenue
in the second quarter of 2021, consisting of $3.3 million in
revenue recognized under its collaboration with GBT and $1.9
million recognized under its collaboration with Incyte.
- Research and development expenses were $33.1 million for the
second quarter of 2022, as compared to $25.8 million for the second
quarter of 2021. This increase was primarily due to the increase in
costs associated with the continued advancement of our clinical and
preclinical programs and employee-related expenses.
- General and administrative (G&A) expenses were $6.9 million
for the second quarter of 2022, as compared to $5.5 million for the
second quarter of 2021. This increase was primarily due to an
increase in employee-related expenses.
- For the second quarter of 2022, Syros reported a net loss of
$34.5 million, or $0.54 per share, compared to a net loss of $22.5
million, or $0.36 per share, for the same period in 2021.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of June 30,
2022 were $86.3 million, as compared with $143.4 million on
December 31, 2021. Based on Syros’s current operating plan and
without giving effect to the merger with TYME, the PIPE financing
and the loan amendment with Oxford, the completion of which cannot
be assured, Syros anticipates that its cash, cash equivalents and
marketable securities of $86.3 million as of June 30, 2022 will
allow it to meet its liquidity requirements into the second quarter
of 2023.
If Syros completes the merger with TYME and the PIPE financing
and gives effect to certain provisions of the loan amendment with
Oxford related to such closings (which is expected to occur in the
second half of 2022), Syros anticipates having approximately $240
million in cash and other capital resources (after transaction
expenses), which it believes will be sufficient to fund its planned
operating expenses and capital expenditure requirements into
2025.
Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to
discuss these second quarter 2022 financial results and provide a
corporate update.
To access the live conference call, please dial (833) 636-1323
(domestic) or (412) 902-4279 (international) and refer to the
“Syros Pharmaceuticals Conference Call.” A webcast of the call will
also be available on the Investors & Media section of the Syros
website at www.syros.com. An archived replay of the webcast will be
available for approximately 30 days following the presentation.
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.
Cautionary Note Regarding 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 of 1933, as amended (the Securities Act) concerning Syros, TYME
Technologies, the proposed transactions and other matters, such as
Syros’ clinical development plans, including with respect to
tamibarotene, SY-2101 and SY-5609, Syros’ ability to deliver
benefit to patients and value to stockholders, the timing and
impact of upcoming clinical and preclinical data readouts, the
timing for submitting a new drug application to the Food and Drug
Administration, the ability to secure additional capital, and the
sufficiency of Syros’ capital resources to fund its operating
expenses and capital expenditure requirements into the second
quarter of 2023 or into 2025 upon the completion of the merger,
PIPE and after giving effect to certain provision of the loan
agreement amendment. 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 Technologies, as well
as assumptions made by, and information currently available to,
management of Syros and TYME Technologies. 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, Syros’ ability to: advance
the development of its programs, including tamibarotene, SY-2101
and SY-5609, 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; sustain the response rates and durability of response
seen to date with its drug candidates; 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; 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. Additional factors
that could cause actual results to differ materially from those
contained in any forward-looking statement include, 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 Technologies to consummate the
transaction, including the PIPE financing; risks related to TYME
Technologies’ continued listing on the Nasdaq Stock Market until
closing of the proposed transactions; risks related to Syros’ and
TYME Technologies’ 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 Technologies 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 June 30, 2022
and TYME Technologies’ Annual Report on Form 10-K for the year
ended March 31, 2022, each of which is on file with the Securities
and Exchange Commission (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 Technologies can give no
assurance that the conditions to the transactions will be
satisfied. Except as required by applicable law, Syros and TYME
Technologies 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 and Where to Find It
In connection with the transactions, Syros filed a Registration
Statement on Form S‑4 (Registration Statement) with the SEC on July
18, 2022, which was subsequently amended on August 1, 2022. The
Registration Statement was declared effective by the SEC on August
8, 2022, and Syros and TYME Technologies intend to commence mailing
of the joint proxy statement/prospectus contained in the
Registration Statement to their respective stockholders on or about
August 10, 2022. Syros may also file other relevant documents with
the SEC regarding the proposed transactions. Investors and security
holders are urged to read the Registration Statement and the joint
proxy statement/prospectus carefully before making any voting or
investment decision with respect to the proposed transactions. The
Registration Statement and the joint proxy statement/prospectus
contain important information about Syros, TYME Technologies, the
transactions and related matters. Investors and security holders
may obtain free copies of the Registration Statement and the joint
proxy statement/prospectus and other documents filed with the SEC
by Syros and TYME Technologies through the web site maintained by
the SEC at www.sec.gov. In addition, investors and security holders
may obtain free copies of the Registration Statement and the joint
proxy statement/prospectus from Syros by contacting
hannahd@sternir.com or from TYME Technologies by contacting
investorrelations@tymeinc.com.
Participants in the Solicitation
Syros and TYME Technologies, 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 and TYME Technologies’ directors and executive
officers, including their interests in the transactions, is
contained in the Registration Statement on file with the SEC. These
documents can be obtained free of charge from the sources indicated
above.
Syros Pharmaceuticals,
Inc.
Selected Condensed
Consolidated Balance Sheet Data
(in thousands)
(unaudited)
June 30,
2022
December 31,
2021
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
86,284
$
143,407
Working capital1
53,018
105,077
Total assets
126,234
182,935
Total stockholders’ equity
31,019
85,218
(1) The Company defines working capital as
current assets less current liabilities. See the Company’s
condensed consolidated financial statements for further details
regarding its current assets and current liabilities.
Syros Pharmaceuticals,
Inc.
Condensed Consolidated
Statement of Operations
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Revenue
$
6,276
$
5,162
$
11,743
$
9,989
Operating expenses:
Research and development
33,100
25,786
58,271
45,815
General and administrative
6,945
5,520
13,894
11,260
Total operating expenses
40,045
31,306
72,165
57,075
Loss from operations
(33,769
)
(26,144
)
(60,422
)
(47,086
)
Interest income
112
12
147
24
Interest expense
(981
)
(969
)
(1,956
)
(1,937
)
Change in fair value of warrant
liability
157
4,611
2,604
12,281
Net loss applicable to common
stockholders
$
(34,481
)
$
(22,490
)
$
(59,627
)
$
(36,718
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.54
)
$
(0.36
)
$
(0.94
)
$
(0.59
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
63,823,789
62,859,500
63,441,918
62,123,658
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220809005360/en/
Media Contact Courtney Solberg Syros Pharmaceuticals
917-698-9253 csolberg@syros.com
Investor Contact Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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