Expanded pipeline with potentially best-in-class, IND-ready
anti-CSF-1R antibody
Syndax Pharmaceuticals (“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 second
quarter ended June 30, 2016 and provided a pipeline update as well
as a review of upcoming milestones. As of June 30, 2016,
Syndax had $125.5 million in cash, cash equivalents and short-term
investments.
“Syndax is building momentum in the execution of our business
strategy. The in-license of SNDX-6352 expands our immuno-oncology
portfolio and further leverages our strong balance sheet and
experienced leadership team,” said Briggs Morrison, M.D., Chief
Executive Officer of Syndax. “By year end 2016, we expect to have
four clinical trials evaluating combination therapies in six cancer
indications, ranging from a late-stage Phase 3 study in breast
cancer to Phase 1 clinical studies in immuno-oncology. As we
continue to build and advance our pipeline, we are guided by our
mission to realize a future in which people with cancer live longer
and better than ever, which we believe will create value for all of
our stakeholders.”
“We continue to advance entinostat’s development
in multiple indications as we began dosing patients in ENCORE 602
in June 2016 and have completed the safety evaluation of the dose
confirmation stage of ENCORE 601,” said Dr. Michael L. Meyers,
Chief Medical Officer of Syndax. “We look forward to communicating
scientific results in the fourth quarter of 2016 and to dosing our
first subjects with SNDX-6352 later this year.”
Pipeline Updates
- Enrollment for E2112, our registrational Phase 3 clinical trial
of entinostat plus Aromasin® (exemestane tablets) in advanced HR+,
HER2- breast cancer has exceeded 50% and continues at an
accelerated pace. The E2112 clinical trial 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 with the U.S. Food and Drug Administration (“FDA”).
Entinostat was granted Breakthrough Therapy designation by the FDA
for HR+ breast cancer following positive results from our Phase 2b
clinical trial, ENCORE 301.
- Syndax completed 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 advanced metastatic or
recurrent non-small cell lung cancer (“NSCLC”) or melanoma. Based
upon a review of the safety data with our study investigators, we
made the decision to proceed to the Phase 2 portion of the clinical
trial. An abstract has been submitted for presentation at the
Society for Immunotherapy of Cancer Annual Meeting in November,
which includes safety, biomarker and initial efficacy data from the
completed Phase 1b portion of ENCORE 601 clinical trial in patients
with NSCLC.
- In June 2016, we dosed our first patient in 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”). We continue
to dose patients and assess the safety of the 5 mg dose in the
trial’s open label Phase 1b portion. An abstract describing
the trial has been submitted for presentation in the Trials in
Progress track at the San Antonio Breast Cancer Symposium in
December 2016.
Key Recent Achievements
- On July 1, 2016, Syndax expanded its immuno-oncology pipeline
by entering into an exclusive worldwide license agreement with UCB
Biopharma Sprl for an anti-CSF-1R monoclonal antibody, UCB 6352,
which Syndax refers to as SNDX-6352. Syndax expects to begin
clinical trials during the fourth quarter of 2016. We believe that
CSF-1R antibodies have the potential to be used to treat a wide
variety of cancer indications in combination with other oncology
agents, including immune checkpoint inhibitors, radiation,
chemotherapy, and entinostat. SNDX-6352 diversifies our approach to
reversing immunosuppression in the tumor microenvironment, and we
believe there is significant opportunity for its rapid and creative
development.
- On July 27, 2016, Syndax announced the members of its
Scientific Advisory Board (“SAB”). The SAB will serve as a
strategic network of scientific and clinical experts to Syndax as
it progresses the development of entinostat in multiple cancer
indications and initiates clinical development of SNDX-6352. The
SAB will also be an integral part of the Company’s strategy as it
continues to assess opportunities to expand its pipeline.
Upcoming Milestones
- Syndax expects to start the three Phase 2 cohorts of ENCORE
601, including patients with NSCLC or Melanoma, in the third
quarter of 2016.
- Syndax anticipates commencing ENCORE 603 in ovarian cancer in
collaboration with Pfizer Inc. and Merck KGaA, Darmstadt, Germany,
in the fourth quarter of 2016.
- Syndax expects to begin the Phase 1 single ascending dose
clinical trial with SNDX-6352 in healthy volunteers to determine
safety and pharmacokinetics during the fourth quarter of 2016.
Syndax Expects To Make Presentations at the Following
Upcoming Conferences
- Syndax management expects to participate in a panel discussion
and host one-on-ones at Citi’s 11th Annual Biotech Conference at
The Mandarin Oriental in Boston on September 8.
- Syndax management expects to make a presentation and host
one-on-ones at the Morgan Stanley Global Healthcare Conference at
the Grand Hyatt in New York on September 12.
- Syndax management expects to make a presentation and host
one-on-ones at the Rodman & Renshaw 18th Annual Global
Investment Conference at the Lotte New York Palace Hotel in New
York on September 13.
- Syndax management expects to make a presentation at the
Discovery on Target Conference at the Westin Boston Waterfront
Hotel in Boston on September 19.
- Syndax management expects to make a presentation and host
one-on-ones at the Ladenburg Thalmann 2nd Annual Global Investment
Conference at the Sofitel New York on September 27.
Second Quarter 2016 Financial Results
As of June 30, 2016, Syndax had cash, cash
equivalents and short-term investments of $125.5 million, and
17,782,150 shares issued and outstanding.
Second quarter 2016 research and development
expenses increased $3.8 million, or 170%, to $6.1 million from $2.3
million for the comparable period in the prior year primarily due
to increased patient accrual costs in E2112, higher expenses
associated with the expansion of ENCORE 601, and the commencement
of ENCORE 602.
General and administrative expenses totaled $2.8
million during the second quarter of 2016, and were below the $3.3
million expense level for the comparable prior year period
primarily due to 2015 restructuring costs, which were partially
offset by increased costs in 2016 related to operating as a public
company.
For the three months ended June 30, 2016, Syndax
reported a net loss attributable to common stockholders of $8.4
million, or $0.47 per share, compared to a net loss attributable to
common stockholders of $26.3 million, or $440.52 per share, for the
comparable period in the prior year. The net loss for the three
months ended June 30, 2016, included non-cash stock-based
compensation expense of $0.8 million related to the issuance of
stock option awards to employees and non-employees.
Conference Call and Webcast
In connection with the earnings release, Syndax
will host a conference call and live audio webcast at 8:00 a.m. ET
on Tuesday, August 9, 2016 to discuss the financial results and
give an update on the Company’s progress.
Conference Call Information: Date: Tuesday, August 9, 2016 Time:
8:00 a.m. ET
Conference ID: 52330666 Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 1-281-542-4259 Live webcast:
http://edge.media-server.com/m/p/n5qtg36c
For those unable to participate in the
conference call or live webcast, a live audio webcast of the call
will also be available on the Investor section of the Company's
website, www.syndax.com, where a webcast replay will also be
available for two weeks following the live event.
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 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 expected to begin
clinical trials during the fourth quarter of 2016 and 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, the ability of
the SAB to contribute to the success of Syndax and its programs 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 DATA |
|
|
|
|
|
|
|
|
|
|
(In
thousands) |
June 30, 2016 |
|
December 31, 2015 |
|
|
Cash, cash equivalents, and short-term investments |
$ |
125,457 |
|
|
$ |
86,489 |
|
|
|
Total
assets |
$ |
127,856 |
|
|
$ |
89,903 |
|
|
|
Total
liabilities |
$ |
21,615 |
|
|
$ |
23,205 |
|
|
|
Total
stockholders' equity (deficit) |
$ |
106,241 |
|
|
$ |
(252,415 |
) |
|
|
|
|
|
|
|
|
|
|
Common
stock outstanding |
|
17,782,150 |
|
|
|
100,124 |
|
|
|
Common
stock and common stock equivalents* |
|
20,855,418 |
|
|
|
15,856,356 |
|
|
|
|
|
|
|
|
|
|
|
*Common
stock and common stock equivalents: |
|
|
|
|
|
|
|
|
June 30, 2016 |
|
December 31, 2015 |
|
|
|
Common
stock |
|
17,782,150 |
|
|
|
100,124 |
|
|
|
|
Convertible
preferred stock |
|
- |
|
|
|
12,872,551 |
|
|
|
|
Options to
purchase common stock |
|
2,715,428 |
|
|
|
2,606,195 |
|
|
|
|
Common
stock warrants |
|
357,840 |
|
|
|
277,486 |
|
|
|
|
|
|
|
20,855,418 |
|
|
|
15,856,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SYNDAX
PHARMACEUTICALS, INC. |
|
(unaudited) |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
(In
thousands, except share and per share data) |
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
License fee
revenue |
$ |
305 |
|
|
$ |
17 |
|
|
$ |
610 |
|
|
$ |
17 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
6,131 |
|
|
|
2,271 |
|
|
|
10,917 |
|
|
|
3,994 |
|
|
|
General and
administrative |
|
2,808 |
|
|
|
3,288 |
|
|
|
7,080 |
|
|
|
5,999 |
|
|
Total operating expenses |
|
8,939 |
|
|
|
5,559 |
|
|
|
17,997 |
|
|
|
9,993 |
|
|
Loss from operations |
|
(8,634 |
) |
|
|
(5,542 |
) |
|
|
(17,387 |
) |
|
|
(9,976 |
) |
|
Other income (expense), net |
|
276 |
|
|
|
(672 |
) |
|
|
(1,301 |
) |
|
|
(1,149 |
) |
|
Net loss |
$ |
(8,358 |
) |
|
$ |
(6,214 |
) |
|
$ |
(18,688 |
) |
|
$ |
(11,125 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders |
$ |
(8,358 |
) |
|
$ |
(26,338 |
) |
|
$ |
(21,286 |
) |
|
$ |
(38,410 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share attributable to common |
|
|
|
|
|
|
|
|
|
stockholders--basic and diluted |
$ |
(0.47 |
) |
|
$ |
(440.52 |
) |
|
$ |
(1.91 |
) |
|
$ |
(649.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common stock |
|
|
|
|
|
|
|
|
|
used to
compute net loss per share attributable |
|
|
|
|
|
|
|
|
|
to common
stockholders--basic and diluted |
|
17,769,514 |
|
|
|
59,788 |
|
|
|
11,155,525 |
|
|
|
59,156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contacts
Barbara Ryan
bryan@syndax.com
(646) 690-7639
Syndax Pharmaceuticals (NASDAQ:SNDX)
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