WALTHAM, Mass., March 3, 2020 /PRNewswire/ -- Syndax
Pharmaceuticals, Inc. ("Syndax," the "Company" or "we")
(Nasdaq:SNDX), a clinical stage biopharmaceutical company
developing an innovative pipeline of cancer therapies, today
reported its financial results for the fourth quarter ended
December 31, 2019. In addition, the
Company provided a clinical and business update. As of December 31, 2019, Syndax had $59.8 million in cash, cash equivalents and
short-term investments.
"With meaningful data readouts expected for each of our
innovative pipeline candidates aimed at addressing unmet need in
some of the most underserved patient populations, 2020 is poised to
be an exciting and transformative year for the Company," said
Briggs W. Morrison, M.D., Chief
Executive Officer of Syndax. "Of note, this includes the final
overall survival readout from E2112, our Phase 3 registration trial
of entinostat plus exemestane in HR+, HER2- breast cancer, in the
second quarter of this year. Supported by the compelling overall
survival benefit observed in the Phase 2b ENCORE 301 trial, we believe the combination
of entinostat and exemestane has strong potential to serve as a
much-needed option in a setting for which existing therapies are
inadequate. We remain on track to file for the regulatory approval
of entinostat in HR+ breast cancer by year end, with a potential
launch expected in 2021, positioning us as a fully-integrated
oncology company."
Dr. Morrison added, "In 2020, we also expect to present the
first clinical data from the AUGMENT-101 trial of SNDX-5613, our
oral Menin inhibitor, in adults with relapsed/refractory acute
leukemias. Supported by a robust body of preclinical data,
including two recently published articles in Cancer Cell and
Science magazine, we believe SNDX-5613 has the
potential to serve as an effective intervention for both NPM1
mutant AML and MLL-r acute leukemias. A presentation of
additional results from our ongoing Phase 1/2 trial of axatilamab,
our anti-CSF-1R monoclonal antibody in patients with cGVHD, is also
anticipated in the fourth quarter of this year."
Pipeline Updates
Entinostat
Syndax continues to anticipate that the E2112 trial will reach
410 death events in the second quarter of 2020, which will trigger
the final overall survival (OS) analysis. E2112 is the Company's
NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of
entinostat, a Class I selective HDAC inhibitor, plus exemestane in
advanced hormone receptor positive, human epidermal growth factor
receptor 2 negative (HR+, HER2-) breast cancer. A positive OS
assessment would allow the Company to file for full regulatory
approval in the U.S.
The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to
entinostat's Breakthrough Therapy designation in HR+ breast cancer,
in which patients receiving the entinostat/exemestane combination
demonstrated a clinically meaningful OS benefit over treatment with
exemestane alone. In preparation for the potential launch of
entinostat in the U.S. in 2021, the Company is actively engaged in
the expansion of its commercial and medical affairs functions.
SNDX-5613
Syndax recently announced two preclinical publications in Cancer
Cell and Science magazine supporting the potential for inhibitors
of the MLL1-Menin interaction to serve as a treatment of acute
leukemia patients with mixed lineage leukemia rearranged (MLL-r) or
nucleophosmin (NPM1) mutations. These findings provide additional
support for the Company's ongoing AUGMENT-101 trial, a Phase 1/2
open-label trial of SNDX-5613, the Company's potent, highly
selective oral Menin inhibitor, in adults with relapsed/refractory
acute leukemias, including MLL-r acute lymphoblastic leukemia
(ALL), MLL-r acute myeloid leukemia (AML) and NPM1 mutant AML.
Enrollment is ongoing in the Phase 1 dose escalation portion of
AUGMENT-101. Following completion of the Phase 1 portion of the
trial, which will establish a recommended Phase 2 dose, the Phase 2
portion will evaluate efficacy, as defined by Complete Response
rate (per International Working Group response criteria), across
three expansion cohorts: MLL-r ALL, MLL-r AML, and NPM1 mutant
AML.
As previously communicated, the Company anticipates presenting
initial clinical data from AUGMENT-101 at a medical conference in
the fourth quarter of 2020. Due to the open-label nature of the
trial, meaningful interim data, including pharmacokinetic,
pharmacodynamic and efficacy data, may be available earlier in the
year.
Axatilamab (SNDX-6352)
Enrollment of patients to the Phase 2 expansion cohort of
axatilamab, the Company's anti-CSF-1R monoclonal antibody, for the
treatment of chronic graft versus host disease (cGVHD) is underway.
The decision to move to the Phase 2 expansion was driven
by recently reported encouraging proof of concept results
from the Phase 1 portion of the trial, in which responses were
observed in all evaluable patients as of the data cutoff date, with
no dose limiting toxicities reported.
The Phase 2 expansion cohort is expected to enroll up to 22
patients to further characterize the safety and efficacy of 1.0
mg/kg of axatilamab administered every two weeks. The Company
expects to present additional results from the Phase 1/2 trial in
the fourth quarter of 2020.
Fourth Quarter 2019 Financial Results
As of December 31, 2019, Syndax had cash, cash equivalents
and short-term investments of $59.8 million and 31.6
million shares issued and outstanding, which includes 27.1 million
shares of common stock and pre-funded warrants to purchase 4.5
million shares of common stock.
Fourth quarter 2019 research and development expenses decreased
to $9.5 million from $15.8 million, and for the full
year decreased to $43.0 million compared to $60.1
million for 2018. The fourth quarter and full year
decreases were primarily due to decreased clinical trial activities
and professional fees.
General and administrative expenses for the fourth quarter 2019
increased to $5.1 million from $3.9 million, and,
for the year ended December 31, 2019, decreased
to $16.1 million compared to $17.3 million for
the prior year. The fourth quarter increase is primarily due to
increased pre-commercialization expenses. The decrease for the full
year was primarily due to decreased professional fees and legal
spending.
For the three months ended December 31, 2019, Syndax
reported a net loss attributable to common stockholders
of $14.0 million or $0.44 per share compared
to $18.8 million or $0.70 per share for the
prior year period. For the year ended December 31, 2019,
Syndax reported a net loss attributable to common stockholders
of $56.0 million or $1.84 per share, compared
to $74.0 million or $2.92 per share for the
prior year.
Financial Update and Guidance
In February 2020, Syndax issued
3,036,719 shares of its common stock and 1,338,287 pre-funded
warrants to purchase common stock at $8.00 per share, representing a premium of 20% to
the share price at market close on Thursday,
January 30, 2020. As a result of the offering, Syndax
received net proceeds of approximately $35.0
million. Following the offering, as of March 3, 2020, shares outstanding totaled 36.0
million, including 30.2 million shares of common stock and
pre-funded warrants to purchase 5.8 million shares of common
stock.
In February 2020 the Company
entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC)
for a term loan of up to $30.0
million, consisting of an initial tranche of $20.0 million that was funded at the closing with
the potential for a second tranche of $10.0
million subject to satisfaction of certain terms and
conditions. Including the $35 million
of proceeds from the equity offering and the $20 million draw of the term loan, our year-end
cash of $60 million has been
supplemented by this additional $55
million.
Today, the Company provided operating expense guidance for the
first and second quarters of 2020. Financial guidance for the
second half of 2020 will be issued after we get the result of the
E2112 study. We expect our operating expenses for the first two
quarters of 2020 to increase over the quarterly operating expenses
we reported for the second half of 2019. R&D expenses will
increase, primarily due to increased development activities for
SNDX-5613, our menin inhibitor, and for axatilamab. G&A
expenses will increase, primarily due to increased entinostat
pre-commercial activities. For each of the first and second
quarters of 2020, research and development expenses are expected to
be $12 to $14
million, and total operating expenses are expected to be
$17 to $19
million. Given our cash operating expense guidance, we
expect to end the second quarter of 2020 with more than
$80 million of cash, which gives us
the financial flexibility to take advantage of key development
milestones well into 2021.
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, March 3.
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: 2786075
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/xxe75xdw
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 Pharmaceuticals is a clinical stage biopharmaceutical
company developing an innovative pipeline of cancer therapies. The
Company's lead product candidate, entinostat, a once-weekly, oral,
small molecule, class I HDAC inhibitor, is being tested in a Phase
3 combination trial with exemestane for treatment of advanced HR+,
HER2- breast cancer and has been evaluated in combination with
several approved PD-1/PD-(L)1 antagonists. The Company's pipeline
also includes SNDX-6352, a monoclonal antibody that blocks the
colony stimulating factor 1 (CSF-1) receptor, and SNDX-5613, a
highly selective inhibitor of the Menin–MLL binding interaction.
For more information, please visit www.syndax.com or follow the
Company on Twitter and LinkedIn.
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 potential use of our product candidates to treat various cancer
indications, Syndax's fourth quarter and full-year 2019 net cash
used in research and development and total operating activities,
and first quarter and full year 2020 operating expense and cash
guidance. Many factors may cause differences between current
expectations and actual results including unexpected safety or
efficacy data observed during preclinical or clinical trials,
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)
|
2019
|
|
2018
|
Cash, cash
equivalents, short-term investments
|
$
59,775
|
|
$
80,911
|
Total
assets
|
$
63,525
|
|
$
83,938
|
Total
liabilities
|
$
31,925
|
|
$
30,891
|
Total stockholders'
equity (deficit)
|
$
31,600
|
|
$
53,047
|
|
|
|
|
|
|
Common stock
outstanding
|
27,140,484
|
|
24,835,951
|
Common stock and
common stock equivalents*
|
37,697,495
|
|
31,088,934
|
|
|
|
|
|
|
*Common stock and
common stock equivalents:
|
|
|
|
Common
stock
|
27,140,484
|
|
24,835,951
|
Options
to purchase common stock
|
6,057,011
|
|
4,252,983
|
Series 1
and 2 warrants
|
4,595,039
|
|
-
|
Pre-funded warrants
|
4,500,000
|
|
2,000,000
|
|
|
|
37,697,495
|
|
31,088,934
|
|
|
|
|
|
|
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)
|
2019
|
|
2018
|
|
2019
|
|
2018
|
License fee
revenue
|
$
380
|
|
$
380
|
|
$
1,517
|
|
$
1,517
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research
and development
|
9,502
|
|
15,821
|
|
42,994
|
|
60,106
|
General
and administrative
|
5,083
|
|
3,892
|
|
16,062
|
|
17,287
|
Total operating
expenses
|
14,585
|
|
19,713
|
|
59,056
|
|
77,393
|
Loss from
operations
|
(14,205)
|
|
(19,333)
|
|
(57,539)
|
|
(75,876)
|
Other income
(expense), net
|
205
|
|
496
|
|
1,492
|
|
1,915
|
Net
loss
|
$
(14,000)
|
|
$
(18,837)
|
|
$
(56,047)
|
|
$
(73,961)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(14,000)
|
|
$
(18,837)
|
|
$
(56,047)
|
|
$
(73,961)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
|
|
|
stockholders--basic and diluted
|
$
(0.44)
|
|
$
(0.70)
|
|
$
(1.84)
|
|
$
(2.92)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
|
|
|
used to
compute net loss per share attributable
|
|
|
|
|
|
|
|
to
common stockholders--basic and diluted
|
31,640,484
|
|
26,804,089
|
|
30,490,783
|
|
25,371,511
|
|
|
|
|
|
|
|
|
|
|
Syndax Contacts
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
Ted Held
ted.held@gcihealth.com
Tel 212.798.9842
SNDX-G
View original
content:http://www.prnewswire.com/news-releases/syndax-pharmaceuticals-reports-fourth-quarter-2019-financial-results-and-provides-clinical-and-business-update-301015765.html
SOURCE Syndax Pharmaceuticals, Inc.