Execution on clinical timelines and advancement of
oncology programs continues with initiation of:
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 third
quarter ended September 30, 2016. In addition, the Company provided
a pipeline update as well as a review of upcoming
milestones. As of September 30, 2016, Syndax had $115.6
million in cash, cash equivalents and short-term investments.
"We continue to advance our innovative pipeline
and anticipate having five clinical trials in six cancer
indications up and running by the end of the year,” said Briggs W.
Morrison, M.D., Chief Executive Officer of Syndax. "We believe the
continued execution of our strategy will bring us closer to
achieving our mission and realizing a future in which people with
cancer live longer and better than ever before.”
"According to ECOG, the accelerated pace of
patient accrual in E2112, the Phase 3 registration clinical trial
of entinostat in advanced HR+, HER2- breast cancer, now puts us on
track to complete enrollment and should allow for the analysis of
the progression-free survival results in the second half of 2017,"
said Dr. Michael L. Meyers, Chief Medical Officer of Syndax.
Pipeline Updates
- E2112 is now 60% enrolled as patient accrual has continued at
an accelerated pace. This Phase 3 registration clinical trial of
entinostat plus Aromasin® (exemestane tablets) in advanced HR+,
HER2- breast cancer is being conducted in collaboration with
Eastern Cooperative Oncology Group-American College of Radiology
Imaging Network Cancer Research Group ("ECOG") and the National
Cancer Institute under a special protocol assessment (“SPA”) with
the U.S. Food and Drug Administration ("FDA"). Entinostat was
granted Breakthrough Therapy designation by the FDA for this
indication following positive results from the Company’s Phase 2b
clinical trial, ENCORE 301.
- The Company initiated enrollment of the three cohorts in the
first stage of the Phase 2 component of ENCORE 601 in patients with
non-small cell lung cancer ("NSCLC") and melanoma. Previously,
Syndax announced the completion of enrollment for the dose
confirmation stage 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® (pembrolizumab), in
patients with NSCLC.
- 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") continues to enroll on schedule.
The trial’s open label Phase 1b portion is designed to assess the
safety of a 5 mg dose.
- Syndax commenced enrollment in the Phase 1 single ascending
dose clinical trial of SNDX-6352 in healthy volunteers to determine
the safety and pharmacokinetics of the anti-CSF-1R monoclonal
antibody.
- In collaboration with Pfizer Inc. and Merck KGaA, Darmstadt,
Germany, Syndax began prescreening patients for enrollment 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.
Upcoming Milestones
- According to ECOG, based upon current enrollment trends, Syndax
expects that E2112, a Phase 3 registrational clinical trial of
entinostat in HR+, HER2- breast cancer, will be fully enrolled and
an analysis of progression-free survival will likely be available
in the second half of 2017.
- Syndax anticipates making a go/no go decision to progress into
the second stage for each arm of ENCORE 601 in the Phase 2 trial in
patients with advanced metastatic or recurrent NSCLC or melanoma by
the end of the first quarter of 2017.
- In collaboration with Pfizer Inc. and Merck KGaA, Darmstadt,
Germany, Syndax anticipates commencing enrollment in the Phase 1b
portion of ENCORE 603 study in patients with ovarian cancer by the
end of the fourth quarter of 2016.
- The Company anticipates safety data from the Phase 1b dose
determination portion of ENCORE 602 in patients with TNBC and the
Phase 1b safety portion of ENCORE 603 in patients with ovarian
cancer in the first half of 2017.
Syndax Expects to Participate in the Following Upcoming
Conferences
- Syndax plans to present safety, biomarker and initial efficacy
data from the completed Phase 1b portions of the ENCORE 601 trial
in patients with NSCLC and preclinical data for SNDX-6352 in two
separate posters at the Society for Immunotherapy of Cancer Annual
Meeting in National Harbor, MD on Friday, November 11, 2016.
- Syndax management will participate in the ROTH Innovations in
Oncology Corporate Access Day in New York on November 17,
2016.
- Syndax management will participate in the Oppenheimer 2016 Life
Sciences Summit in New York on November 29, 2016.
- Syndax management will present at the 28th Annual Piper Jaffray
Healthcare Conference being held in New York on November 29 and 30,
2016.
- Syndax will present a poster describing the ENCORE 602 Phase
1b/2 trial in the Trials in Progress track at the San Antonio
Breast Cancer Symposium on December 6 through 10, 2016.
- Syndax management will participate in the Citi 2016 Global
Healthcare Conference being held in New York on December 7 and 8,
2016.
- Syndax management will participate in the Guggenheim Securities
4th Annual Boston Healthcare Conference in Boston on December 13,
2016.
Third Quarter 2016 Financial Results
As of September 30, 2016, Syndax had cash, cash
equivalents and short-term investments of $115.6 million and
18,189,880 shares issued and outstanding.
Third quarter 2016 research and development
expenses increased to $12.3 million from $3.0 million for the
comparable period in the prior year 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.
General and administrative expenses totaled $3.3
million during the third quarter of 2016, similar to the $3.2
million expense level for the comparable prior year period.
For the three months ended September 30, 2016,
Syndax reported a net loss attributable to common stockholders of
$15.0 million or $0.84 per share compared to $56.7 million or
$790.85 per share for the comparable prior year period. The net
loss for the three months ended September 30, 2016 included
non-cash stock-based compensation expense of $0.8 million related
to the issuance of stock option awards to employees.
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, November 10, 2016.
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: 96707118 Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259 Live webcast:
http://edge.media-server.com/m/p/3py8kcmc
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 registration 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 potentially 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, without limitation, the factors contained
under the caption "Risk Factors" in Syndax’s quarterly reports on
Form 10-Q. 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, 2016 |
|
December 31, 2015 |
|
Cash, cash equivalents, and
short-term investments |
$ |
115,567 |
|
|
$ |
86,489 |
|
|
Total assets |
$ |
117,729 |
|
|
$ |
89,903 |
|
|
Total liabilities |
$ |
23,895 |
|
|
$ |
23,205 |
|
|
Total stockholders' equity
(deficit) |
$ |
93,834 |
|
|
$ |
(252,415 |
) |
|
|
|
|
|
|
|
|
Common stock outstanding |
|
18,189,880 |
|
|
|
100,124 |
|
|
Common stock and common stock
equivalents* |
|
21,055,803 |
|
|
|
15,856,356 |
|
|
|
|
|
|
|
|
|
*Common stock and common stock
equivalents: |
|
|
|
|
|
|
|
September 30, 2016 |
|
December 31, 2015 |
|
|
Common stock |
|
18,189,880 |
|
|
|
100,124 |
|
|
|
Convertible preferred
stock |
|
- |
|
|
|
12,872,551 |
|
|
|
Options to purchase
common stock |
|
2,508,083 |
|
|
|
2,606,195 |
|
|
|
Common stock
warrants |
|
357,840 |
|
|
|
277,486 |
|
|
|
|
|
|
21,055,803 |
|
|
|
15,856,356 |
|
|
|
|
|
|
|
|
|
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) |
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
License fee
revenue |
|
$ |
305 |
|
|
$ |
305 |
|
|
$ |
915 |
|
|
$ |
322 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
12,274 |
|
|
|
2,968 |
|
|
|
23,191 |
|
|
|
6,962 |
|
General and
administrative |
|
3,269 |
|
|
|
3,195 |
|
|
|
10,349 |
|
|
|
9,194 |
|
Total operating expenses |
|
15,543 |
|
|
|
6,163 |
|
|
|
33,540 |
|
|
|
16,156 |
|
Loss from operations |
|
|
(15,238 |
) |
|
|
(5,858 |
) |
|
|
(32,625 |
) |
|
|
(15,834 |
) |
Other income (expense), net |
|
269 |
|
|
|
(1,873 |
) |
|
|
(1,032 |
) |
|
|
(3,022 |
) |
Net
loss |
|
|
$ |
(14,969 |
) |
|
$ |
(7,731 |
) |
|
$ |
(33,657 |
) |
|
$ |
(18,856 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders |
$ |
(14,969 |
) |
|
$ |
(56,656 |
) |
|
$ |
(36,255 |
) |
|
$ |
(95,066 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss
per share attributable to common stockholders--basic and
diluted |
$ |
(0.84 |
) |
|
$ |
(790.85 |
) |
|
$ |
(2.70 |
) |
|
$ |
(1,500.34 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common stock used to compute net loss
per share attributable to common stockholders--basic and
diluted |
|
17,899,481 |
|
|
|
71,639 |
|
|
|
13,419,919 |
|
|
|
63,363 |
|
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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