WALTHAM, Mass., May 6, 2019 /PRNewswire/ -- Syndax
Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage
biopharmaceutical company developing an innovative pipeline of
cancer therapies, today reported its financial results for the
first quarter ended March 31, 2019.
In addition, the Company provided a clinical and business update.
As of March 31, 2019, Syndax had
$92.7 million in cash, cash
equivalents and short-term investments.
"We are pleased to report that E2112, our Phase 3 registration
trial of entinostat plus exemestane in HR+, HER2- breast cancer,
has passed its fourth interim overall survival analysis," said
Briggs W. Morrison, M.D., Chief
Executive Officer of Syndax. "E2112 was designed to replicate the
compelling overall survival results obtained in the Phase
2b ENCORE 301 trial which led to
Breakthrough Therapy designation. The next overall survival
assessment is expected in the fourth quarter of this year. We
remain confident in the potential that the addition of entinostat
to exemestane will result in a positive survival benefit, which
would allow us to file for full regulatory approval in this
indication."
Dr. Morrison added, "We also look forward to filing an IND for
SNDX-5613, our targeted menin inhibitor, later this quarter.
Supported by a robust preclinical dataset, we believe this
therapeutic class has the potential to make a meaningful impact for
patients with genetically-defined acute leukemias for whom limited
effective therapies exist."
Pipeline Updates
Entinostat
ECOG-ACRIN has informed the Company that following its fourth
preplanned interim overall survival (OS) analysis, the E2112 trial
will continue as planned until either an OS benefit is observed, or
the final target number of events occur. E2112 is Syndax's
NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of
entinostat, a Class I selective HDAC inhibitor, plus exemestane in
advanced hormone receptor positive, human epidermal growth factor
receptor 2 negative (HR+, HER2-) breast cancer. The next interim
analysis for the OS endpoint is scheduled for 4Q19, with a final OS
assessment, if necessary, to be conducted in 2Q20. Any positive OS
assessment would enable the Company to file for full regulatory
approval. The E2112 trial design was informed by the Phase
2b ENCORE 301 trial, the results of
which led to entinostat's Breakthrough Therapy designation in HR+,
HER2- breast cancer, in which patients receiving the
entinostat/exemestane combination demonstrated a statistically
significant OS benefit.
At the American Association of Cancer Research (AACR) Annual
Meeting held March 29 - April 3,
2019, Syndax presented data from the non-small cell lung
cancer (NSCLC) and melanoma cohorts of the ENCORE 601 trial of
entinostat in combination with KEYTRUDA®
(pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1)
therapy. These data provided further evidence that the addition of
entinostat to pembrolizumab may overcome resistance to
immunotherapy in melanoma and NSCLC patients whose disease
progressed on or after anti-PD-1 therapy. As the Company has
previously indicated, following availability of positive E2112 OS
results, it will determine whether to advance its entinostat-PD-1
combination programs into one or more registration trials.
SNDX-5613
Syndax continues to expect to file an Investigational New Drug
(IND) application with the U.S. Food and Drug Administration (FDA)
for its targeted menin inhibitor, SNDX-5613, later this quarter,
with the initiation of a Phase 1 clinical trial in a defined subset
of acute leukemia patients expected to follow shortly
thereafter.
SNDX-6352
The Company continues to anticipate initial results from the
Phase 1 dose escalation trial of SNDX-6352, Syndax's anti-CSF-1R
monoclonal antibody, in patients with chronic graft versus host
disease (cGVHD) in the second half of the year. The objectives of
this trial are to evaluate the safety and preliminary efficacy of
SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and
schedule.
First Quarter 2019 Financial Results
As of March 31, 2019, Syndax had
cash, cash equivalents and short-term investments of $92.7 million and 31.6 million shares and share
equivalents issued and outstanding.
In March 2019, Syndax issued 4.5
million shares of its common stock and prefunded warrants at an
offering price of $6.00, as well as
warrants to purchase up to 4.5 million shares of its common stock,
with half at an exercise price of $12.00 per share and the remaining half at
an exercise price of $18.00 per
share. As a result of the offering, Syndax received aggregate net
proceeds of approximately $27.4
million.
First quarter 2019 research and development expenses decreased
to $11.3 million from $15.3 million. The first quarter decrease was
primarily due to reduced CMC activities and decreased clinical
activities.
General and administrative expenses for the first quarter 2019
decreased to $3.9 million from
$4.8 million. The decrease was
primarily due to decreased pre-commercialization expenses and
decreased professional fees.
For the three months ended March 31,
2019, Syndax reported a net loss attributable to common
stockholders of $14.3 million or
$0.53 per share compared to
$19.4 million or $0.79 per share for the prior year period.
Financial Guidance
Today the Company provided operating expense guidance for the
second quarter and full year 2019. For the second quarter and full
year 2019, research and development expenses are expected to be
$9 to $10
million and $46 to
$50 million, respectively, and total
operating expenses are expected to be $13 to $14 million
and $60 to $64
million, respectively.
Conference Call and Webcast
In connection with the earnings release, Syndax's management
team will host a conference call and live audio webcast at
4:30 p.m. ET today, Monday, May 6, 2019.
The live audio webcast and accompanying slides may be accessed
through the Events & Presentations page in the Investors
section of the Company's website at www.syndax.com.
Alternatively, the conference call may be accessed through the
following:
Conference ID: 4292817
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: https://edge.media-server.com/m6/p/2ahgcwxy
For those unable to participate in the conference call or
webcast, a replay will be available for 30 days on the Investors
section of the Company's website, www.syndax.com.
About Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals is a clinical stage biopharmaceutical
company developing an innovative pipeline of cancer therapies. The
Company is developing its lead product candidate, entinostat, a
once-weekly, oral, small molecule, class I HDAC inhibitor, in
combination with exemestane and has evaluated it in combination
with several approved PD-1/PD-(L)1 antagonists. The Company's
pipeline also includes SNDX-6352, a monoclonal antibody that blocks
the colony stimulating factor 1 (CSF-1) receptor, as well as a
portfolio of potent and selective inhibitors targeting the binding
interaction of Menin with MLL-r, including its lead candidate
SNDX-5613. For more information, please visit www.syndax.com or
follow the Company on Twitter and LinkedIn.
Syndax's Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend," "believe" and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Syndax's expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from these forward-looking
statements. Forward-looking statements contained in this press
release include, but are not limited to, statements about the
progress, timing, clinical development and scope of clinical trials
and the reporting of clinical data for Syndax's product candidates,
the potential use of our product candidates to treat various cancer
indications, Syndax's second quarter and full-year 2019 net cash
used in research and development and operating activities; and the
amount of Syndax's cash, cash equivalents and marketable securities
at the end of 2019. Many factors may cause differences between
current expectations and actual results including unexpected safety
or efficacy data observed during preclinical or clinical trials,
clinical trial site activation or enrollment rates that are lower
than expected, changes in expected or existing competition, changes
in the regulatory environment, failure of Syndax's collaborators to
support or advance collaborations or product candidates and
unexpected litigation or other disputes. Other factors that may
cause Syndax's actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in Syndax's filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained
therein. Except as required by law, Syndax assumes no obligation to
update any forward-looking statements contained herein to reflect
any change in expectations, even as new information becomes
available.
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
(In
thousands)
|
2019
|
|
2018
|
Cash, cash
equivalents, short-term and long-term investments
|
$
92,742
|
|
$
80,911
|
Total
assets
|
$
99,392
|
|
$
83,938
|
Total
liabilities
|
$
30,766
|
|
$
30,891
|
Total stockholders'
equity (deficit)
|
$
68,626
|
|
$
53,047
|
|
|
|
|
|
|
Common stock
outstanding
|
27,095,779
|
|
24,835,951
|
Common stock and
common stock equivalents*
|
41,819,938
|
|
31,088,934
|
|
|
|
|
|
|
*Common stock and
common stock equivalents:
|
|
|
|
|
Common
stock
|
27,095,779
|
|
24,835,951
|
|
Common stock warrants
(pre-funded)
|
4,500,000
|
|
2,000,000
|
|
|
Common stock and
pre-funded stock warrants
|
31,595,779
|
|
26,835,951
|
|
Options to purchase
common stock
|
5,629,120
|
|
4,252,983
|
|
Common stock warrants
(series 1 and 2)
|
4,595,039
|
|
-
|
|
|
Total common stock
and common stock equivalents
|
41,819,938
|
|
31,088,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
(In thousands,
except share and per share data)
|
2019
|
|
2018
|
License fee
revenue
|
$
379
|
|
$
379
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
11,279
|
|
15,339
|
|
General and
administrative
|
3,911
|
|
4,791
|
Total operating
expenses
|
15,190
|
|
20,130
|
Loss from
operations
|
(14,811)
|
|
(19,751)
|
Other income,
net
|
509
|
|
353
|
Net
loss
|
$
(14,302)
|
|
$
(19,398)
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(14,302)
|
|
$
(19,398)
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
stockholders--basic
and diluted
|
$
(0.53)
|
|
$
(0.79)
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
used to compute net
loss per share attributable
|
|
|
|
|
to common
stockholders--basic and diluted
|
27,023,466
|
|
24,478,269
|
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
David Rosen
Argot Partners
david.rosen@argotpartners.com
Tel 212.600.1902
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.