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
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.
Syros Pharmaceuticals, Inc.
Selected Condensed Consolidated Balance
Sheet Data
(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.
Condensed Consolidated Statements of
Operations
(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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190501005105/en/
Media Contact:Naomi AokiSyros
Pharmaceuticals617-283-4298naoki@syros.com
Investor Contact:Hannah DeresiewiczStern Investor
Relations, Inc.212-362-1200hannah.deresiewicz@sternir.com
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