WALTHAM, Mass., Nov. 5, 2018 /PRNewswire/ -- Syndax
Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:
SNDX), a clinical stage biopharmaceutical company developing an
innovative pipeline of cancer therapies, today reported its
financial results for the third quarter ended September 30, 2018. In addition, the Company
provided a clinical and business update. As of September 30, 2018, Syndax had $89.6 million in cash, cash equivalents and
short-term investments.
"The last several months have been marked by exciting progress
across multiple programs, culminating with our recent announcement
of plans to commence what will become our second registration
study: a focused, biomarker-driven registration trial to evaluate
entinostat in combination with pembrolizumab in patients with
non-small cell lung cancer whose disease has progressed after PD-1
therapy," said Briggs W. Morrison,
M.D., Chief Executive Officer of Syndax. "We remain highly
encouraged by the potential for a positive overall survival readout
for E2112, our Phase 3 registration trial of entinostat plus
exemestane in HR+, HER2- breast cancer, which would allow us to
file for full regulatory approval in this indication. We look
forward to reporting on multiple exciting value inflection points
across our ENCORE I/O combination trials in the coming months."
Pipeline Updates
Entinostat
- At the International Association for the Study of Lung Cancer
(IASLC) 19th World Conference on Lung Cancer (WCLC) in September,
the Company presented data from the full cohort of PD-(L)1
refractory non-small cell lung cancer (NSCLC) patients enrolled in
the ENCORE 601 trial of entinostat in combination with
KEYTRUDA® (pembrolizumab). The data continued to support
the prior observation of enhanced clinical benefit in a
subpopulation of patients with elevated baseline levels of
peripheral classical blood monocytes. In October, the Company
announced plans to commence a focused, biomarker-driven, randomized
registration trial comparing the entinostat-pembrolizumab
combination to standard of care chemotherapy in patients whose
disease has progressed after both platinum-based chemotherapy and
PD-1 antagonist therapy. The trial will seek to validate peripheral
classical monocytes as a marker of response to the combination and
to determine whether the combination can improve progression free
survival (PFS) over standard of care chemotherapy in the high
monocyte population. The Company anticipates beginning the trial in
the first half of 2019.
- In October, Syndax announced that enrollment has concluded in
E2112, the Phase 3 registration trial of entinostat plus exemestane
in advanced hormone receptor positive, human epidermal growth
factor receptor 2 negative (HR+, HER2-) breast cancer, with a total
of 608 patients enrolled. ECOG-ACRIN Cancer Research Group and the
National Cancer Institute informed the Company that the trial did
not meet the statistical hurdle for the first primary endpoint of
improving PFS, which would have provided the earliest regulatory
filing opportunity. Following the most recent interim overall
survival (OS) analysis conducted by the trial's Data Safety
Monitoring Committee, ECOG-ACRIN also informed Syndax that the
trial is continuing as planned, with the next interim analysis for
the OS primary endpoint scheduled for the second quarter of 2019.
Additional interim analyses will be conducted every six months
until either an OS benefit is observed, or the final target number
of events occur. E2112 was designed, and obtained Breakthrough
Therapy Designation for this indication, based on positive Phase
2b OS results. Any positive OS
assessment would enable the Company to file for full regulatory
approval.
- The Company will make a decision later this year on next steps
for entinostat in combination with KEYTRUDA® in melanoma
patients whose disease has progressed following PD-1 therapy.
- Enrollment in the expanded stage 1 ENCORE 601 cohort of
patients with microsatellite stable colorectal cancer (MSS-CRC, n =
37) is now complete. A decision on whether to continue to the
second stage of this cohort is expected in the first quarter of
2019.
- As previously communicated, target enrollment is complete in
both the Phase 2 portion of ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of
entinostat plus Genentech's PD-(L)1 inhibitor,
TECENTRIQ® (atezolizumab), in patients with triple
negative breast cancer, and the Phase 2 portion of ENCORE 603,
evaluating entinostat in combination with Pfizer/Merck KGaA's
PD-(L)1 inhibitor, BAVENCIO® (avelumab), in patients
with ovarian cancer. Topline results for ENCORE 603 are expected in
the first quarter of 2019, with topline results from ENCORE 602 to
follow in the second quarter of 2019.
- ENCORE 606, the Phase 1b/2 trial
evaluating entinostat in combination with NKTR-214, Nektar's
CD122-biased agonist, is expected to begin enrolling patients with
melanoma whose disease has progressed after PD-1 antagonist therapy
in the second quarter of 2019.
SNDX-6352
- Enrollment has recently been initiated in the Phase 1 dose
escalation trial of SNDX-6352, the Company's anti-CSF-1R monoclonal
antibody, in patients with chronic graft versus host disease
(cGVHD). 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. Initial results are
anticipated in the second half of 2019.
- A Phase 1/1b dose escalation
study evaluating the safety of SNDX-6352 remains ongoing with
patients continuing to receive doses of SNDX-6352 alone or in
combination with IMFINZI® (durvalumab), AstraZeneca's
human monoclonal antibody directed against PD-L1. The Company
anticipates identifying the recommended Phase 2 dose and schedule
for SNDX-6352 monotherapy and in combination with durvalumab in the
second quarter of 2019.
Menin-MLLr Inhibitor Portfolio
- Development of the Company's portfolio of Menin-Mixed Lineage
Leukemia (MLLr) inhibitors is ongoing, and the Company has selected
a lead compound, SNDX-5613, to continue through Investigational New
Drug (IND)-enabling studies. The Company expects to file an IND
with the FDA and initiate a Phase 1 clinical trial in patients with
a defined subset of acute leukemias in the second quarter of
2019.
- Syndax's Menin-MLLr program will be featured in two
presentations at the upcoming 60th American Society of
Hematology (ASH) Annual Meeting & Exposition being held
December 1-4, 2018 in San Diego.
Third Quarter 2018 Financial Results
As of September 30, 2018, Syndax
had cash, cash equivalents and short-term investments of
$89.6 million and 26.1 million shares
issued and outstanding (including a prefunded warrant for 2.0
million shares).
In the third quarter of 2018 and through November 2, 2018, the Company sold 2.1 million
shares of its common stock with net proceeds of approximately
$15.5 million pursuant to its
at-the-market arrangement.
Third quarter 2018 research and development expenses increased
to $14.1 million from $12.2 million for the comparable period in the
prior year, an increase of $1.9 million, or 16%, due to an increase in
development activities of $0.8 million and increased employee
compensation expense of $1.1 million. The increase in development
activities was primarily related to the development of the
Menin-MMLr program and increased activities in the 602 ENCORE trial
partly offset by the completion of Phase 1 clinical pharmacology
trials and decrease in E2112 costs. The increase in employee
compensation costs was primarily due to increased headcount.
General and administrative expenses increased to $4.1 million during the third quarter of 2018,
compared to $3.6 million for the
comparable period in the prior year, an increase of $0.6 million, or 16%. The increase in
general and administrative expenses was primarily due to an
increase employee related expenses of $0.3
million and in professional and legal fees of $0.2 million.
For the three months ended September 30,
2018, Syndax reported a net loss attributable to common
stockholders of $17.3 million or
$0.68 per share compared to
$15.1 million or $0.68 per share for the comparable prior year
period.
Financial Guidance
Today, the Company provided operating expense guidance for the
fourth quarter and full year 2019. For the fourth quarter of
2018, research and development expenses are expected to be
$13 to $15
million and total operating expenses are expected to be
$17 to $19
million. Total operating expenses for the fourth quarter of
2018 are expected to include approximately $1.5 million of non-cash stock compensation
expense. The year-end 2018 cash balance is expected to be
approximately $80 million.
For the full year 2019, research and development expenses are
expected to be $54 to $58 million, and total operating expenses are
expected to be $68 to $73 million. Total operating expenses for 2019
are expected to include approximately $6
million of non-cash stock compensation expense.
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, November 5, 2018.
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: 8397904
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: https://edge.media-server.com/m6/p/c9yprfxf
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 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 MLLr.
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, and Syndax's third quarter and full-year 2018 net cash
used in research and development and total operating activities.
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
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
(In
thousands)
|
2018
|
|
2017
|
Cash, cash
equivalents, short-term and long-term investments
|
$
89,599
|
|
$
133,220
|
Total
assets
|
$
96,467
|
|
$
137,186
|
Total
liabilities
|
$
32,193
|
|
$
32,867
|
Total stockholders'
equity
|
$
64,274
|
|
$
104,319
|
|
|
|
|
|
|
Common stock
outstanding
|
24,051,364
|
|
24,390,033
|
Common stock and
common stock equivalents*
|
30,324,010
|
|
28,139,705
|
|
|
|
|
|
|
*Common stock and
common stock equivalents:
|
|
|
|
|
Common
stock
|
24,051,364
|
|
24,390,033
|
|
Options to purchase
common stock
|
4,272,646
|
|
3,391,832
|
|
Common stock
warrants
|
2,000,000
|
|
357,840
|
|
|
|
30,324,010
|
|
28,139,705
|
|
|
|
|
|
|
|
|
|
|
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
(In thousands,
except share and per share data)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
License fee
revenue
|
$
379
|
|
$
305
|
|
$
1,138
|
|
$
915
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
14,095
|
|
12,188
|
|
44,286
|
|
31,603
|
|
General and
administrative
|
4,125
|
|
3,563
|
|
13,395
|
|
11,777
|
Total operating
expenses
|
18,220
|
|
15,751
|
|
57,681
|
|
43,380
|
Loss from
operations
|
(17,841)
|
|
(15,446)
|
|
(56,543)
|
|
(42,465)
|
Other income,
net
|
503
|
|
358
|
|
1,419
|
|
766
|
Net
loss
|
$
(17,338)
|
|
$
(15,088)
|
|
$
(55,124)
|
|
$
(41,699)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(17,338)
|
|
$
(15,088)
|
|
$
(55,124)
|
|
$
(41,699)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
|
|
|
|
stockholders--basic
and diluted
|
$
(0.68)
|
|
$
(0.68)
|
|
$
(2.21)
|
|
$
(2.08)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
|
|
|
|
used to compute net
loss per share attributable
|
|
|
|
|
|
|
|
|
to common
stockholders--basic and diluted
|
25,471,587
|
|
22,239,996
|
|
24,888,738
|
|
20,004,409
|
Syndax Contacts
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