WALTHAM, Mass., Nov. 7, 2017 /PRNewswire/ -- Syndax
Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:
SNDX), a clinical stage biopharmaceutical company developing
entinostat and SNDX-6352 in multiple cancer indications, today
reported its financial results for the third quarter ended
September 30, 2017. In addition, the
Company provided a clinical and business update. As of September 30, 2017, Syndax had $120.6 million in cash, cash equivalents and
short-term investments.
The Company continues to expand its pipeline, and recently
announced that it has entered into an exclusive worldwide license
agreement with Vitae Pharmaceuticals, Inc., a subsidiary of
Allergan plc, for a portfolio of preclinical, orally-available
small molecule inhibitors of the interaction of Menin with the
Mixed Lineage Leukemia ("MLL") protein. Syndax plans to initially
study these compounds for the treatment of a genetically-defined
subset of acute leukemias with chromosomal rearrangements in the
MLL gene ("MLL-r").
All four cohorts of ENCORE 601, an open-label, Simon two-stage
design, Phase 1b/2 clinical trial evaluating the combination of
entinostat, the Company's class I selective HDAC inhibitor, plus
Merck's anti-PD-1 (programmed death receptor-1) blocking therapy,
KEYTRUDA®, continue to proceed on schedule. Enrollment
in the first stage of the cohort of patients with microsatellite
stable colorectal cancer (MSS-CRC) is complete, and a decision on
whether to continue to the second stage is expected in the first
quarter of 2018. Enrollment in the second stage of the PD-(L)1
refractory non-small cell lung cancer (NSCLC) cohort is complete,
and Syndax expects to share updated data from this cohort in the
first half of 2018.
"As we near the end of 2017, the momentum we've built throughout
the year continues to yield meaningful progress and growth for our
pipeline of potential best-in-class candidates," said Briggs W. Morrison, M.D., Chief Executive
Officer of Syndax. "The recent expansion of our pipeline represents
what we believe will be a long-term value enhancing transaction for
the Company, while also potentially changing the treatment paradigm
for acute leukemic patients harboring MLL translocations, where
there exists a high unmet need. For entinostat, the ENCORE 601
program remains on track and we look forward to presenting data
from both NSCLC cohorts, as well as biomarker data from the
melanoma cohort, at the upcoming SITC Annual Meeting. We are also
developing a global registration plan for entinostat in combination
with a PD-1 inhibitor for patients with PD-1 refractory melanoma.
We anticipate sharing details of our plan in the first half of
2018, in parallel with the full Phase 2 data from the melanoma
cohort of ENCORE 601.
Pipeline Updates
- The Phase 3 registration trial of entinostat plus exemestane in
advanced HR+, HER2- breast cancer, E2112, is 83% enrolled as of the
end of October. ECOG-ACRIN Cancer Research Group, the trial
sponsor, has notified the Company that the Data Safety Monitoring
Committee (DSMC) completed the final progression free survival
analysis and the first interim analysis for overall survival. The
results of this analysis are held confidentially by the ECOG-ACRIN
study statistician and the DSMC. No communication regarding this
analysis will be released until completion of enrollment, which
ECOG-ACRIN expects will occur in the first half of 2018.
- The ENCORE 601 cohort enrolling NSCLC patients naïve to PD-(L)1
therapy has satisfied the pre-specified efficacy criteria for
advancement to the second stage, with ≥ 4 responses out of 17.
- Enrollment in the second stage of the ENCORE 601 cohort
enrolling patients with PD-(L)1 refractory NSCLC is complete. Data
from this cohort is expected to be available in the first half of
2018.
- Following a meeting with the U.S. Food and Drug Administration
(FDA) in June, the Company is continuing to meet with individual
regulatory agencies in Europe to
align on a global registration plan for entinostat in combination
with a PD-1 inhibitor for patients with PD-(L)1 refractory
melanoma. The Company anticipates being in a position to outline a
regulatory plan for this indication around the time that full Phase
2 data from the melanoma cohort of ENCORE 601 are available in the
first half of 2018.
- An oral presentation highlighting the data from stage one of
both the ENCORE 601 NSCLC cohorts, as well as a poster presentation
covering the biomarker data from the ENCORE 601 melanoma cohort,
will be presented at the upcoming Society of Immunotherapy of
Cancer (SITC) Annual Meeting. The Company anticipates sharing full
Phase 2 trial data from both the PD-(L)1 refractory NSCLC and
melanoma cohorts at a medical congress in the first half of 2018.
Details on both SITC presentations are available here.
- Enrollment in the first stage of the cohort enrolling patients
with microsatellite stable (MSS)--CRC is complete, and a decision
on whether to advance to the second stage is expected in the first
half of 2018. At least 2 confirmed objective responses are required
to proceed to the second stage.
- Enrollment continues in the ENCORE 602 and ENCORE 603 trials,
both of which are aimed at exploring the ability of entinostat to
enhance the efficacy of checkpoint (PD-L1) inhibitor therapies.
ENCORE 602, the Phase 1b/2 clinical trial evaluating the
combination of entinostat plus Genentech's PD-L1 inhibitor,
TECENTRIQ®, in patients with triple negative breast
cancer, is now expected to complete enrollment in the Phase 2
portion in the first half of 2018, with results anticipated in the
second half of the year. ENCORE 603, the Phase 1b/2 clinical trial
evaluating entinostat in combination with Pfizer/Merck KGaA's
BAVENCIO® in patients with ovarian cancer, continues to
enroll patients into the Phase 2 portion and is on track to
complete enrollment in the first half of 2018, with results
anticipated in the first half of 2019.
- Dosing of patients with solid tumors in the Phase 1 multiple
ascending dose (MAD) clinical trial of SNDX-6352, the Company's
anti-CSF-1R monoclonal antibody, has commenced. A poster
highlighting the safety, pharmacokinetic and pharmacodynamic data
from the single ascending dose (SAD) trial of SNDX-6352 in healthy
volunteers will be presented at the upcoming SITC Annual Meeting.
Details on the presentation are available here.
- The Company entered into an exclusive worldwide license
agreement with Vitae Pharmaceuticals, Inc., a subsidiary of
Allergan plc, for a portfolio of preclinical, orally-available
small molecule inhibitors of the interaction of Menin with the MLL
protein. These compounds have potential application in the
treatment of a genetically-defined subset of acute leukemias with
chromosomal rearrangements in the MLL gene ("MLL-r"). The Company
expects to initiate clinical trials in 2019.
Third Quarter 2017 Financial Results
As of September 30, 2017, Syndax
had cash, cash equivalents and short-term investments of
$120.6 million and 22.3 million
shares issued and outstanding. In October
2017, the Company reported the sale of 2.0 million common
shares in a registered direct offering with net proceeds of
$24.8 million.
Third quarter 2017 research and development expenses decreased
to $12.2 million from $12.3 million for the comparable period in the
prior year. The decrease was primarily due to increased clinical
trial activities of $3.9 million
and increased employee compensation expense of $0.9 million, offset by a $5.0 million upfront payment in 2016 related to
the in-license of SNDX-6352 from UCB. The increase in clinical
trial activities was primarily due to additional cohorts added to
ENCORE 601, increased activities in ENCORE 602 and ENCORE 603,
costs related to SNDX-6352, Phase 1 clinical pharmacology trials
and CMC activities. The increase in employee compensation costs was
primarily due to increased headcount.
General and administrative expenses totaled $3.6 million during the third quarter of 2017
compared with $3.3 million in the
comparable period in the prior year. The increase in general and
administrative expenses was primarily due to an increase in
non-cash stock-based compensation of $0.4 million and an increase in salary
expense of $0.2 million due to
increased headcount, offset by decreased legal fees of $0.3 million.
For the three months ended September 30,
2017, Syndax reported a net loss attributable to common
stockholders of $15.1 million, or
$0.68 per share, compared to
$15.0 million, or $0.84 per share, for the comparable prior year
period.
Financial Guidance
Today the Company provided operating expense guidance for the
fourth quarter and full year 2017. For the fourth quarter and
full year 2017, research and development expenses are expected to
be $15 to $18 million and
$47 to $50 million, respectively, and
total operating expenses are expected to be $19 to $22 million and $63
to $66 million, respectively. Research and development
expenses for the fourth quarter includes $5.0 million paid to Allergan in connection with
the Menin-MLL license. This expense will be offset on a cash basis
with a $5.0 million development
milestone earned in the fourth quarter under our agreement with
KHK.
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, Tuesday, November 7, 2017.
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: 4569859
Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259
Live webcast: https://edge.media-server.com/m6/p/dq9yr3ta
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 is a clinical stage biopharmaceutical company developing
an innovative pipeline of cancer therapies. Our lead product
candidate, entinostat, which was granted Breakthrough Therapy
designation by the FDA following positive results from our Phase 2b
clinical trial, ENCORE 301, is currently being evaluated in a Phase
3 clinical trial in combination with exemestane for advanced
hormone receptor positive, human epidermal growth factor receptor 2
negative breast cancer. Given its potential ability to block the
function of immune suppressive cells in the tumor microenvironment,
entinostat is also being evaluated in combination with approved
PD-1 antagonists. Ongoing Phase 1b/2 clinical trials combine
entinostat with KEYTRUDA from Merck & Co., Inc. for non-small
cell lung cancer, melanoma and colorectal cancer; with
TECENTRIQ® from Genentech, Inc. for triple negative
breast cancer; and with BAVENCIO® from Pfizer Inc. and
Merck KGaA, Darmstadt, Germany,
for ovarian cancer. Our second clinical stage product candidate,
SNDX-6352, is a monoclonal antibody that blocks the colony
stimulating factor 1 (CSF-1) receptor and may also block the
function of immune suppressive cells in the tumor microenvironment.
SNDX-6352 is being evaluated in a Phase 1 clinical trial and is
expected to be developed to treat a variety of cancers.
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,
and the potential use of our product candidates to treat various
cancer indications. Many factors may cause differences between
current expectations and actual results including unexpected safety
or efficacy data observed during preclinical or clinical studies,
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
|
|
|
|
|
|
|
|
|
(In
thousands)
|
September 30,
2017
|
|
December 31,
2016
|
|
ASSETS
|
|
|
|
|
Cash, cash
equivalents, and short-term investments
|
$
120,594
|
|
$
105,330
|
|
Other
assets
|
3,899
|
|
3,683
|
|
Total
assets
|
$
124,493
|
|
$
109,013
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities
|
$
14,207
|
|
$
10,366
|
|
Deferred revenue,
less current portion
|
13,305
|
|
14,220
|
|
Other
liabilities
|
267
|
|
288
|
|
Total
liabilities
|
27,779
|
|
24,874
|
|
Total stockholders'
equity
|
96,714
|
|
84,139
|
|
Total liabilities and
stockholders' equity
|
$
124,493
|
|
$
109,013
|
|
|
|
|
|
|
|
|
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)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
License fee
revenue
|
$
305
|
|
$
305
|
|
$
915
|
|
$
915
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
12,188
|
|
12,274
|
|
31,603
|
|
23,191
|
|
General and
administrative
|
3,563
|
|
3,269
|
|
11,777
|
|
10,349
|
Total operating
expenses
|
15,751
|
|
15,543
|
|
43,380
|
|
33,540
|
Loss from
operations
|
(15,446)
|
|
(15,238)
|
|
(42,465)
|
|
(32,625)
|
Other income
(expense), net
|
358
|
|
269
|
|
766
|
|
(1,032)
|
Net loss
|
$
(15,088)
|
|
$
(14,969)
|
|
$
(41,699)
|
|
$
(33,657)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(15,088)
|
|
$
(14,969)
|
|
$
(41,699)
|
|
$
(36,255)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
|
|
|
|
stockholders--basic
and diluted
|
$
(0.68)
|
|
$
(0.84)
|
|
$
(2.08)
|
|
$
(2.70)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
|
|
|
|
used to compute net
loss per share attributable
|
|
|
|
|
|
|
|
|
to common
stockholders--basic and diluted
|
22,239,996
|
|
17,899,481
|
|
20,004,409
|
|
13,419,919
|
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
Eliza Schleifstein
Argot Partners
eliza@argotpartners.com
Tel 973.361.1546
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.