Encore 601 refractory melanoma cohort to proceed to
second stage of Phase 2; pre-specified objective response criteria
satisfied
Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we")
(Nasdaq:SNDX), a clinical stage biopharmaceutical company focused
on developing entinostat and SNDX-6352 in multiple cancer
indications, today reported its financial results for the fourth
quarter and year ended December 31, 2016. In addition, the Company
provided a pipeline update as well as a review of upcoming
milestones. As of December 31, 2016, Syndax had $105.3 million
in cash, cash equivalents and short-term investments.
"We’re pleased to report that the melanoma
cohort of ENCORE 601 has met the pre-specified objective response
threshold to advance into the second stage of the phase 2 trial and
will re-open enrollment immediately,” said Briggs W. Morrison,
M.D., Chief Executive Officer of Syndax. “The goal of the
first stage of the trial was to determine whether the combination
of entinostat and Merck’s anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab), could generate a meaningful
response in patients enrolled in each cohort. Specifically, in the
cohort of melanoma patients who had experienced disease progression
while on a PD-1 antagonist, a minimum of 2 out of 13 patients
needed to demonstrate a confirmed objective response for this
cohort to advance to the next stage. The trial will now enroll an
additional 21 patients, with accrual targeted to be completed by
the end of the fourth quarter of this year.”
"This is an encouraging early signal for
entinostat combined with KEYTRUDA®, as this population of patients
is poorly served by existing therapies. We are looking forward to
seeing the stage one results of this combination in the non-small
cell lung cancer cohorts of ENCORE 601 as well," said Michael L.
Meyers, M.D., Ph.D., Chief Medical Officer of Syndax.
Pipeline Updates
- According to the Eastern Cooperative Oncology Group-American
College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research
Group, E2112, a Phase 3 registration trial of entinostat plus
Aromasin® (exemestane tablets) in advanced HR+, HER2- breast
cancer, continues to enroll. The trial is being conducted in
collaboration with ECOG-ACRIN and the National Cancer Institute
(NCI) under a Special Protocol Assessment (SPA) with the U.S. Food
and Drug Administration (FDA).
- The Company has completed enrollment in the first stage of the
three cohorts in the Phase 2 portion of ENCORE 601, an open-label,
Phase 1b/2 clinical trial evaluating the combination of entinostat
plus Merck's anti-PD-1 blocking therapy, KEYTRUDA®, in patients
with melanoma and NSCLC. Following an analysis of the results from
stage one of the two NSCLC cohorts, the Company will make a
decision whether to expand either or both of these cohorts into the
second stage of the trial in the first half of 2017.
- The Phase 1b portion of ENCORE 602, a Phase 1b/2 clinical trial
evaluating the combination of entinostat plus Genentech's PD-L1
inhibitor, TecentriqTM (atezolizumab), in patients with triple
negative breast cancer (TNBC) has completed enrollment and,
following a thorough review of the safety data, the Phase 2 portion
of the trial was recently initiated.
- The Company entered into a Cooperative Research and Development
Agreement (CRADA) with the NCI of the National Institutes of Health
(NIH), and will collaborate with the NCI’s Laboratory of Tumor
Immunology and Biology to evaluate the therapeutic potential of
entinostat, as well as SNDX-6352, the Company’s anti-CSF-1R
monoclonal antibody currently in development as a treatment for
neoplastic diseases.
- Syndax, in collaboration with Pfizer Inc. and Merck KGaA,
Darmstadt, Germany, initiated enrollment of patients in the Phase
1b portion of ENCORE 603, a Phase 1b/2 clinical trial evaluating
entinostat in combination with an investigational monoclonal
antibody targeting PDL-1, avelumab, in patients with ovarian
cancer.
- During the fourth quarter of 2016, Syndax commenced enrollment
in the Phase 1 single ascending dose clinical trial of SNDX-6352 in
healthy volunteers to determine the safety, pharmacokinetics and
pharmacodynamics of the anti-CSF-1R monoclonal antibody.
Upcoming Milestones
- Based upon current enrollment trends ECOG-ACRIN anticipates
that enrollment in E2112 could be completed and
progression-free survival data available by the end of
this year.
- Syndax expects to complete enrollment in the second stage of
the melanoma cohort in ENCORE 601 by the end of the fourth quarter
of 2017, with data anticipated in the first half of
2018.
- The Company expects to present data from the Phase 1 single
ascending dose clinical trial of SNDX-6352 at a scientific congress
in the fourth quarter of 2017.
Syndax Expects to Participate in the Following Upcoming
Conferences
- Cowen & Co. 37th Annual Healthcare Conference, March 6-8,
2017 in Boston.
- 29th Annual ROTH Capital Partners Healthcare Conference, March
12-15, 2017 in Orange County, CA.
- 27th Annual Oppenheimer & Co. Healthcare Conference, March
21-22, 2017 in New York.
Fourth Quarter and Year-end 2016 Financial
Results
As of December 31, 2016, Syndax had cash, cash
equivalents and short-term investments of $105.3 million and
18,223,723 shares issued and outstanding.
Fourth quarter 2016 research and development
expenses increased to $8.5 million from $2.6 million for the
comparable period in the prior year. Research and development
expenses for the year ended December 31, 2016 increased to $31.7
million compared to $9.5 million for the prior year. These
increases were primarily due to increased patient accrual costs in
E2112, higher expenses associated with the Phase 2 expansion of
ENCORE 601, and the commencement of ENCORE 602 as well as the
upfront payment related to expanding the pipeline with SNDX-6352
and initiation of a Phase 1 trial.
General and administrative expenses totaled $3.0
million during the fourth quarter of 2016 and $13.3 million for the
year, similar to the $2.4 million and $11.6 million expense level
for the respective prior year periods.
For the three months ended December 31, 2016,
Syndax reported a net loss attributable to common stockholders of
$10.8 million or $0.59 per share compared to $8.8 million or
$105.57 per share for the comparable prior year period. For the
year ended December 31, 2016, Syndax reported a net loss
attributable to common stockholders of $47.1 million or $3.22 per
share, compared to $103.8 million or $1,519.27 per share for the
prior year period.
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, Thursday, March 2, 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: 63366789 Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259 Live webcast:
http://edge.media-server.com/m/p/6txfuwhh
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 focused on developing an innovative pipeline of combination
therapies in multiple cancer indications. 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 for advanced hormone receptor positive, human
epidermal growth factor receptor 2 negative breast cancer. Syndax
is developing entinostat, which has direct effects on both cancer
cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R
monoclonal antibody, to enhance the body's immune response on
tumors that have shown sensitivity to immunotherapy. Entinostat is
being evaluated as a combination therapeutic in Phase 1b/2 clinical
trials with Merck & Co., Inc. for non-small cell lung cancer
and melanoma; with Genentech, Inc. for TNBC; and with Pfizer Inc.
and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352
is being evaluated in a single ascending dose Phase 1 clinical
trial and is expected to be developed to treat a variety of
cancers. For more information on Syndax, please visit
www.syndax.com.
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 SNDX-6352 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 |
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
(In
thousands) |
|
2016 |
|
|
2015 |
|
|
Cash, cash equivalents, and short-term investments |
$ |
105,330 |
|
$ |
86,489 |
|
|
Total
assets |
$ |
109,013 |
|
$ |
89,903 |
|
|
Total
liabilities |
$ |
24,874 |
|
$ |
23,205 |
|
|
Total
stockholders' equity (deficit) |
$ |
84,139 |
|
$ |
(252,415 |
) |
|
|
|
|
|
|
|
|
Common
stock outstanding |
|
18,223,723 |
|
|
100,124 |
|
|
Common
stock and common stock equivalents* |
|
21,142,300 |
|
|
15,856,356 |
|
|
|
|
|
|
|
|
|
*Common stock and common stock equivalents: |
|
|
|
|
|
Common stock |
|
18,223,723 |
|
|
100,124 |
|
|
|
Convertible preferred stock |
|
- |
|
|
12,872,551 |
|
|
|
Options to purchase common stock |
|
2,560,737 |
|
|
2,606,195 |
|
|
|
Common stock warrants |
|
357,840 |
|
|
277,486 |
|
|
|
|
|
|
21,142,300 |
|
|
15,856,356 |
|
|
|
|
|
|
|
|
|
SYNDAX
PHARMACEUTICALS, INC. |
|
(unaudited) |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
(In
thousands, except share and per share data) |
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
License fee revenue |
$ |
305 |
|
|
$ |
305 |
|
|
$ |
1,220 |
|
|
$ |
627 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
8,474 |
|
|
|
2,587 |
|
|
|
31,665 |
|
|
|
9,549 |
|
|
|
General and administrative |
|
2,972 |
|
|
|
2,397 |
|
|
|
13,321 |
|
|
|
11,591 |
|
|
Total operating expenses |
|
11,446 |
|
|
|
4,984 |
|
|
|
44,986 |
|
|
|
21,140 |
|
|
Loss from operations |
|
(11,141 |
) |
|
|
(4,679 |
) |
|
|
(43,766 |
) |
|
|
(20,513 |
) |
|
Other income (expense), net |
|
326 |
|
|
|
(584 |
) |
|
|
(706 |
) |
|
|
(3,606 |
) |
|
Net loss |
$ |
(10,815 |
) |
|
$ |
(5,263 |
) |
|
$ |
(44,472 |
) |
|
$ |
(24,119 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
$ |
(10,815 |
) |
|
$ |
(8,779 |
) |
|
$ |
(47,070 |
) |
|
$ |
(103,845 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common |
|
|
|
|
|
|
|
|
|
stockholders--basic and diluted |
$ |
(0.59 |
) |
|
$ |
(105.57 |
) |
|
$ |
(3.22 |
) |
|
$ |
(1,519.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common stock |
|
|
|
|
|
|
|
|
|
used to
compute net loss per share attributable |
|
|
|
|
|
|
|
|
|
to common
stockholders--basic and diluted |
|
18,193,027 |
|
|
|
83,157 |
|
|
|
14,619,716 |
|
|
|
68,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contacts
Heather Savelle
Argot Partners
heather@argotpartners.com
Tel 646.395.3734
Media Contact
Eliza Schleifstein
Argot Partners
eliza@argotpartners.com
Tel 973.361.1546
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