WALTHAM, Mass., Aug. 10, 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 second quarter ended
June 30, 2017. In addition, the
Company provided a clinical and business update. As of June 30, 2017, Syndax had $130.0 million in cash, cash equivalents and
short-term investments.
Enrollment in all cohorts of ENCORE 601 have proceeded rapidly.
The second stage of the ENCORE 601 cohort enrolling PD-1
(programmed death receptor-1) refractory melanoma patients has
reached its accrual target. Enrollment in the PD-1 refractory
non-small cell lung cancer (NSCLC) cohort remains on track, and is
expected to be complete in the fourth quarter. The Company
also announced that the first patient has been dosed in the ENCORE
601 cohort enrolling microsatellite stable colorectal cancer (CRC)
patients.
"The second quarter was marked by continued progress across our
clinical pipeline. The initial results from ENCORE 601 provide the
first clinical evidence that entinostat may reverse resistance to
immune checkpoint therapies," said Briggs
W. Morrison, M.D., Chief Executive Officer of Syndax. "We
had a productive Type B meeting with the FDA in June to discuss
potential registration paths for entinostat when used in
combination with a PD-1 inhibitor for the treatment of melanoma
patients who have progressed on checkpoint therapy. We are now
evaluating the options discussed with the FDA and will provide an
update by the end of the year.
Pipeline Updates
- ECOG-ACRIN Cancer Research Group, sponsor of E2112, the Phase 3
registration trial of entinostat plus exemestane in advanced HR+,
HER2- breast cancer, expects the progression free survival analysis
to be available in the first half of 2018 directly following
completion of enrollment. As of the end of July, the trial was 78%
enrolled.
- A number of patients enrolled in the ENCORE 601 cohort of NSCLC
patients naïve to PD-(L)1 therapy remain on drug, with a
determination on whether the cohort has satisfied the pre-specified
efficacy criteria for advancement to the second stage of the trial
expected by year end. The pre-specified objective response
threshold to advance this cohort into the second stage of the Phase
2 trial has been revised to ≥ 4 responses out of 17 (versus the
previous benchmark of ≥ 3 responses out of 13) in order to
incorporate Phase 1b patients dosed at the recommended 5 mg dose of
entinostat. Similarly, the cohort of PD-(L)1 refractory NSCLC
patients, announced in May to have met the pre-specified objective
response threshold to advance into the second stage of the Phase 2
trial, used revised criteria requiring ≥3 responses out of 31
(versus the previous benchmark of >2 responses out of 20) in
order to incorporate Phase 1b patients dosed at entinostat 5
mg.
- Enrollment in the second stage of the PD-(L)1 refractory
melanoma cohort of ENCORE 601 has completed, and the second stage
of the PD-(L)1 refractory NSCLC cohort of ENCORE 601 is expected to
complete enrollment in the fourth quarter. Syndax expects to
present data from stage one of the NSCLC cohorts, as well as
biomarker data from the melanoma cohort, at the Society of
Immunotherapy of Cancer (SITC) Annual Meeting in the fall, and the
full trial data from both the refractory NSCLC and melanoma cohorts
at a medical congress in the first half of 2018.
- Dosing has been initiated in the ENCORE 601 cohort of patients
with microsatellite stable CRC. This new cohort, announced in
April 2017, employs a Simon two-stage
design enrolling 13 patients in the first stage, and requires ≥ 2
confirmed objective responses to proceed to the second stage. A
decision on whether to advance to the second stage of the CRC
cohort is expected in the first half of 2018.
- Enrollment is also progressing in the two additional trials
aimed at exploring the ability of entinostat to enhance the
efficacy of PD-L1 inhibitor therapies, ENCORE 602 and ENCORE 603.
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 expected to complete enrollment in the Phase 2 portion
by the end of the fourth quarter. ENCORE 603, the Phase 1b/2
clinical trial evaluating entinostat in combination with
Pfizer/Merck KGaA's BAVENCIO® in patients with ovarian
cancer, recently began enrolling patients into the Phase 2 portion
and is expected to complete enrollment in the first half of
2018.
- Enrollment is now complete in the Phase 1 single ascending dose
(SAD) clinical trial of SNDX-6352 in healthy volunteers to
determine the safety, pharmacokinetics and pharmacodynamics of the
anti-CSF-1R monoclonal antibody. The Company expects to present
data from this study at a scientific congress in the fourth quarter
of 2017. Syndax also plans to initiate a multiple ascending dose
(MAD) trial in cancer patients in the third quarter of 2017.
Syndax Expects to Participate in the Following Upcoming
Investor Conferences
- Citi 12th Annual Biotech Conference, September 6-7, 2017 in Boston
- Morgan Stanley Healthcare Conference, September 11-13, 2017 in New York
- Cantor Fitzgerald 2017 Global Healthcare Conference,
September 25-27, 2017 in New York
Second Quarter 2017 Financial Results
As of June 30, 2017, Syndax had
cash, cash equivalents and short-term investments of $130.0 million and 22,219,843 shares issued and
outstanding. This includes aggregate net proceeds of $48.7 million, raised in a follow-on offering in
May 2017 whereby 3,950,190 shares of
common stock were sold at an offering price of $13.25 per share.
Second quarter 2017 research and development expenses increased
to $9.9 million from $6.1 million for the comparable period in the
prior year due to increases in clinical trial activities of
$2.3 million, employee
compensation expense of $0.8 million, and legal and consultant
expenses of $0.6 million. The
increase in clinical trial activities was primarily due to
increases in spending related to the additional cohorts added to
ENCORE 601, increased activities in ENCORE 602 and ENCORE 603,
start-up costs related to SNDX-6352, our 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 $4.3 million during the second quarter of 2017
compared with $2.8 million in the
comparable period in the prior year. The increase in general and
administrative expenses was primarily due to an increase in
employee compensation of $1.0 million combined with increases in
consulting expenses of $0.4 million. The increase in employee
compensation of $1.0 million was
primarily due to increases in non-cash stock-based compensation of
$0.6 million, combined with an
increase in salary expense of $0.4 million due to increased headcount.
For the three months ended June 30,
2017, Syndax reported a net loss attributable to common
stockholders of $13.6 million, or
$0.70 per share, compared to
$8.4 million, or $0.47 per share, for the comparable prior year
period.
Financial Guidance
Today the Company provided operating expense guidance for the
third quarter and full year 2017. For the third quarter and
full year 2017, research and development expenses are expected to
be $12.0 to $14.0 million and
$46.0 to $51.0 million, respectively,
and total operating expenses are expected to be $16.0 to $18.0 million and $63.0 to $68.0 million, respectively.
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, August 10, 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: 53140486
Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259
Live webcast: http://edge.media-server.com/m/p/pko7iyj3
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 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
product candidate, SNDX-6352, is a monoclonal antibody that blocks
the CSF-1 receptor and may also block the function of immune
suppressive cells in the tumor microenvironment. 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.
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 STATEMENTS OF OPERATIONS DATA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
(In thousands,
except share and per share data)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
License fee
revenue
|
$
305
|
|
$
305
|
|
$
610
|
|
$
610
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research
and development
|
9,862
|
|
6,131
|
|
19,414
|
|
10,917
|
General
and administrative
|
4,285
|
|
2,808
|
|
8,215
|
|
7,080
|
Total operating
expenses
|
14,147
|
|
8,939
|
|
27,629
|
|
17,997
|
Loss from
operations
|
(13,842)
|
|
(8,634)
|
|
(27,019)
|
|
(17,387)
|
Other income
(expense), net
|
203
|
|
276
|
|
409
|
|
(1,301)
|
Net
loss
|
$
(13,639)
|
|
$
(8,358)
|
|
$
(26,610)
|
|
$
(18,688)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(13,639)
|
|
$
(8,358)
|
|
$
(26,610)
|
|
$
(21,286)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
|
|
|
stockholders--basic
and diluted
|
$
(0.70)
|
|
$
(0.47)
|
|
$
(1.41)
|
|
$
(1.91)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
|
|
|
used
to compute net loss per share attributable
|
|
|
|
|
|
|
|
to
common stockholders--basic and diluted
|
19,497,581
|
|
17,769,514
|
|
18,868,089
|
|
11,155,525
|
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED BALANCE SHEETS DATA
|
|
|
|
|
|
|
(In
thousands)
|
June 30,
2017
|
|
December 31,
2016
|
ASSETS
|
|
|
|
Cash, cash
equivalents, and short-term investments
|
$
129,955
|
|
$
105,330
|
Other
assets
|
4,711
|
|
3,683
|
Total
assets
|
$
134,666
|
|
$
109,013
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities
|
$
11,505
|
|
$
10,366
|
Deferred revenue,
less current portion
|
13,610
|
|
14,220
|
Other
liabilities
|
214
|
|
288
|
Total
liabilities
|
25,329
|
|
24,874
|
Total stockholders'
equity
|
109,337
|
|
84,139
|
Total liabilities and
stockholders' equity
|
$
134,666
|
|
$
109,013
|
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.