Successfully Completed $70 Million Financing
On Track for Multiple Data Readouts for Clinical-Stage Programs in
2019 and 2020
Management to Host Conference Call at 8:30 a.m. ET Today
CAMBRIDGE, Mass.–(BUSINESS WIRE)–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 March 31, 2019 and provided an update on
recent accomplishments and upcoming events.
“Our first quarter accomplishments mark important progress against our
strategic priorities for 2019,” said Nancy Simonian, M.D., Chief
Executive Officer of Syros. “We refined our clinical development
strategies for SY-1425 and SY-1365 with the aim of achieving
proof-of-concept as soon as 2020 in three patient populations with high
unmet needs that we believe offer opportunities for accelerated
development. We presented new preclinical data supporting our
mechanistic rationale for the ongoing development of SY-1365 in ovarian
and breast cancers and highlighted the potency, selectivity and
anti-tumor activity of SY-5609, our oral CDK7 inhibitor, further
demonstrating our leadership in CDK7 inhibition. Following our
successful financing in April, we believe we have sufficient funds to
advance our clinical programs beyond potential proof-of-concept
readouts, while continuing to execute on our long-term vision of
building a fully integrated company with medicines that provide a
profound benefit for patients.”
Upcoming Milestones:
SY-1425
-
Syros plans to open an additional cohort in the ongoing Phase 2 trial
in the third quarter of 2019 evaluating the safety and efficacy of
SY-1425 in combination with azacitidine in RARA or IRF8
biomarker-positive patients with relapsed or refractory acute myeloid
leukemia (AML). Syros expects to report potential proof-of-concept
data from this cohort in 2020 that, if positive, could enable a
decision to move toward a registration study. -
Syros plans to complete enrollment in mid-2019 in the ongoing Phase 2
trial cohort evaluating the safety and efficacy of SY-1425 in
combination with azacitidine in RARA or IRF8
biomarker-positive patients with newly diagnosed AML who are not
suitable candidates for standard chemotherapy. -
Syros plans to report updated data on SY-1425 in combination with
azacitidine in the second half of 2019 in newly diagnosed AML patients
who are not suitable candidates for standard chemotherapy.
SY-1365
-
Syros plans to report initial clinical data in the fourth quarter of
2019 from the expansion portion of its ongoing Phase 1 trial,
including initial efficacy and safety assessments from the cohort
evaluating SY-1365 as a single agent in high-grade serous ovarian
cancer patients who have had three or more prior lines of therapy;
initial safety and pharmacokinetic data from the cohort evaluating
SY-1365 in combination with carboplatin in high-grade serous ovarian
cancer patients who have had one or more prior lines of therapy; and
initial safety, efficacy and mechanistic data from the cohort
evaluating SY-1365 as a single agent in patients with advanced solid
tumors accessible for biopsy. -
Syros expects to report additional data from these cohorts, including
potential proof-of-concept data from the ongoing cohort in high-grade
serous ovarian cancer patients who have had one or more prior lines of
therapy, in 2020. Syros also expects to report potential
proof-of-concept data from an ongoing cohort evaluating SY-1365 as a
single agent in patients with relapsed ovarian clear cell cancer and
initial data from an ongoing cohort in hormone receptor (HR)-positive
CDK4/6 inhibitor-resistant breast cancer patients in 2020.
SY-5609
-
Syros plans to complete investigational new drug-enabling studies of
SY-5609 in 2019 to support the initiation of a Phase 1 oncology trial
in early 2020.
Recent Pipeline Highlights:
-
In March 2019, Syros opened for enrollment the Phase 1 trial cohort
evaluating SY-1365 in patients with relapsed ovarian clear cell cancer. -
In April 2019, Syros presented new preclinical data on SY-1365 at the
American Association for Cancer Research (AACR) Annual Meeting. The
data showed that 90 percent of high-grade ovarian cancer
patient-derived xenograft models with prospectively defined RB pathway
alterations responded to treatment with SY-1365. These data support
the ongoing development of SY-1365 in ovarian and breast cancer
patient populations that are enriched for RB pathway alterations, as
well as the evaluation of these alterations as potential biomarkers of
response to SY-1365. -
Also at AACR, Syros presented new preclinical data on SY-5609,
demonstrating the potency, selectivity and anti-tumor activity in
preclinical models of triple-negative breast cancer and ovarian cancer.
Recent Corporate Highlights:
-
In April 2019, Syros announced the closing of two concurrent
underwritten public offerings, which together resulted in aggregate
gross proceeds from the offerings of approximately $70 million, before
deducting underwriting discounts and commissions and offering expenses
of approximately $4.6 million. The offerings consisted of (i)
8,667,333 shares of Syros common stock and accompanying Class A
warrants to purchase up to 1,951,844 shares of its common stock, at a
combined price to the public of $7.50 per common share and
accompanying Class A warrant and (ii) 666 shares of its Series A
convertible preferred stock, which are convertible into 666,000 shares
of its common stock, and accompanying Class A warrants to purchase up
to 166,500 shares of its common stock, at a combined price to the
public of $7,500 per Series A share and accompanying Class A warrant.
Each Class A warrant has an exercise price of $8.625 per share and
expires on October 10, 2022.
First Quarter 2019 Financial Results:
Syros had cash, cash equivalents and marketable securities of $75.9
million as of March 31, 2019, as compared with $99.7 million on December
31, 2018. Cash and cash equivalents as of March 31, 2019 do not include
the net proceeds of approximately $65.4 million from the Company’s April
2019 financing.
For the first quarter of 2019, Syros reported a net loss of $16.5
million, or $0.49 per share, compared to a net loss of $14.5 million, or
$0.48 per share, for the same period in 2018.
-
Revenues were $0.5 million for the first quarter of 2019, as compared
to $0.4 million for the same period in 2018. Revenues in both the
first quarter of 2019 and first quarter of 2018 were earned under
Syros’ collaboration with Incyte Corporation. -
Research and development (R&D) expenses were $12.6 million for the
first quarter of 2019, as compared to $11.1 million for the same
period in 2018. This increase was primarily attributable to continued
advancement of the Company’s existing clinical trials and advancement
of its preclinical programs, including the advancement of SY-5609 into
investigational new drug application (IND)-enabling studies. -
General and administrative (G&A) expenses were $4.9 million for the
first quarter of 2019, as compared to $4.1 million for the same period
in 2018. This increase was primarily attributable to an increase in
employee-related expenses.
Financial Guidance
Based on its current plans, Syros believes that its existing cash, cash
equivalents and marketable securities will be sufficient to fund its
planned operating expenses and capital expenditure requirements to the
end of the first quarter of 2021.
Conference Call and Webcast:
Syros will host a conference call today at 8:30 a.m. ET to discuss these
first quarter 2019 financial results and provide a corporate update.
To access the live conference call, please dial 866-595-4538 (domestic)
or 636-812-6496 (international), and refer to conference ID 5435957. 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 pioneering the understanding of the non-coding regulatory
region of the genome to advance a new wave of medicines that control the
expression of genes. Syros has built a proprietary platform that is
designed to systematically and efficiently analyze this unexploited
region of DNA to identify and drug novel targets linked to genomically
defined patient populations. Because gene expression is fundamental to
the function of all cells, Syros’ gene control platform has broad
potential to create medicines that achieve profound and durable benefit
across a range of diseases. Syros is currently focused on cancer and
monogenic diseases and is advancing a growing pipeline of gene control
medicines. Syros’ lead drug candidates are SY-1425, a selective RARα
agonist in a Phase 2 clinical trial for genomically defined subsets of
patients with acute myeloid leukemia, and SY-1365, a selective CDK7
inhibitor in a Phase 1 clinical trial focused on patients with ovarian
and breast cancers. Syros is also developing a deep preclinical and
discovery pipeline, including SY-5609, an oral CDK7 inhibitor, as well
as programs in immuno-oncology and sickle cell disease. Led by a team
with deep experience in drug discovery, development and
commercialization, Syros is located in Cambridge, Mass.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995,
including without limitation statements regarding the Company’s ability
to advance its clinical-stage programs, including the of the timing and
quantity of clinical data to be reported from the combination cohorts of
the ongoing Phase 2 clinical trial of SY-1425 and the expansion phase of
the ongoing Phase 1 clinical trial of SY-1365, as well as the opening of
a new cohort in the SY-1425 trial ; the ability to complete enrollment
in the cohort of the ongoing clinical Phase 2 clinical trial of SY-1425
in biomarker-positive newly diagnosed unfit AML patients; the ability to
achieve rapid clinical proof of concept and take advantage of
fast-to-market opportunities for SY-1425 and SY-1365; the predictive
value of the Company’s RARA and IRF8 biomarkers and the
relevance of the RB pathway alterations as potential biomarkers of
response to SY-1365; the ability to complete IND-enabling preclinical
studies and begin clinical development of SY-5609; the Company’s ability
to fund its planned operations to the end of the first quarter of 2021;
and the benefits of Syros’ gene control platform and product development
pipeline. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’
‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘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 Syros’ ability to: advance the development of its
programs, including SY-1425 and SY-1365, 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; successfully progress SY-5609 through
IND-enabling preclinical and toxicology studies; replicate scientific
and non-clinical data in clinical trials; successfully develop a
companion diagnostic test to identify patients with the RARA and IRF8
biomarkers; 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 the collaboration agreement with
Incyte; 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 Syros’
Annual Report on Form 10-K for the year ended December 31, 2018, which
is on file with the Securities and Exchange Commission; and risks
described in other filings that Syros makes with the Securities and
Exchange Commission in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof, and
Syros expressly disclaims any obligation to update any forward-looking
statements, whether because of new information, future events or
otherwise.
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Syros Pharmaceuticals, Inc. |
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Selected Condensed Consolidated Balance Sheet Data |
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(in thousands) |
||||||
|
(unaudited) |
||||||
| March 31, 2019 | December 31, 2018 | |||||
| Cash, cash equivalents and marketable securities | $ | 75,866 | $ | 99,679 | ||
|
Working capital1 |
62,784 | 82,205 | ||||
| Total assets | 88,428 | 106,766 | ||||
| Total stockholders’ equity | 64,018 | 78,586 | ||||
|
Syros Pharmaceuticals, Inc. |
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|
Condensed Consolidated Statements of Operations |
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(in thousands, except share and per share data) |
||||||||
|
(unaudited) |
||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenue | $ | 454 | $ | 370 | ||||
| Operating expenses: | ||||||||
| Research and development | 12,562 | 11,116 | ||||||
| General and administrative | 4,865 | 4,075 | ||||||
| Total operating expenses | 17,427 | 15,191 | ||||||
| Loss from operations | (16,973 | ) | (14,821 | ) | ||||
| Other income, net | 512 | 358 | ||||||
| Net loss | $ | (16,461 | ) | $ | (14,463 | ) | ||
| Net loss per share – basic and diluted | $ | (0.49 | ) | $ | (0.48 | ) | ||
|
Weighted-average number of common shares used in net loss per share – basic and diluted |
33,766,333 | 30,335,164 | ||||||
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.
Contacts
Media Contact:
Naomi Aoki
Syros Pharmaceuticals
617-283-4298
naoki@syros.com
Investor Contact:
Hannah Deresiewicz
Stern Investor
Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com