WALTHAM, Mass., May 11, 2021 /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 first quarter ended March 31, 2021. In addition, the Company provided
a clinical and business update.
"We are excited to provide an update on the positive interim
Phase 1 data from the ongoing AUGMENT-101 trial of SNDX-5613 in
patients with mixed lineage leukemia rearranged (MLLr) and
nucleophosmin (NPM1c) mutant acute leukemias," said Briggs W. Morrison, M.D., Chief Executive
Officer of Syndax. "As Dr. Eytan
Stein indicated in his presentation, complete eradication of
leukemia need not occur simultaneously with complete recovery of
blood cell counts, and today we are able to share that two prior
responders have advanced from complete response with incomplete
platelet recovery (CRp) to a complete response (CR). The benefit we
observe in AUGMENT-101 support our strong conviction that SNDX-5613
has the potential to meaningfully shape the treatment paradigm for
these patients who are in desperate need of improved therapeutic
options. As previously announced, we have identified a candidate
recommended Phase 2 dose (RP2D) and look forward to commencing the
pivotal Phase 2 portion of the trial."
"In addition, we continue to make progress with axatilimab in
patients with chronic graft versus host disease (cGVHD). We are
pleased to announce today that we have completed enrollment of 23
patients in the Phase 2 expansion portion of the Phase 1/2 trial.
We look forward to sharing full updated results from the Phase 1/2
trial later this year, with top-line data from the ongoing pivotal
AGAVE-201 trial expected in 2023. Supported by emerging data,
we firmly believe that axatilimab has the potential to benefit many
of the more than 10,000 patients diagnosed with cGVHD in the U.S.
each year."
Recent Progress and Anticipated Milestones
SNDX-5613
The Company today announced new data from the ongoing Phase 1
dose escalation portion of the Phase 1/2 AUGMENT-101 trial of
SNDX-5613, a highly selective oral menin inhibitor, in patients
with MLLr and NPM1c mutant relapsed/refractory (R/R) acute
leukemias. The new data reported today, showed two prior responders
have improved from CRp to CR with no evidence of minimal residual
disease (MRD-). With the addition of these two patients, a total of
7/31 patients (23%) have achieved CR/CRh.
Syndax previously announced positive data from the Phase 1
portion of the AUGMENT-101 trial in April
2021 and hosted a conference call featuring Eytan M. Stein, M.D., Assistant Attending
Physician and Director, Program for Drug Development in Leukemia,
Department of Medicine at Memorial Sloan Kettering Cancer Center.
As of the data cutoff date, the overall response rate (ORR) among
evaluable patients was 48% (n=15), with 67% (n=10) of these
responders achieving MRD- status, and four proceeding to receive
stem cell transplant. The ORR in evaluable patients harboring an
MLL-rearrangement (n=24), was 54% (n=13), and in evaluable patients
harboring an NPM1c mutation (n=7), was 29% (n=2). Across all
patients enrolled in the trial as of the data cutoff date (n=43),
SNDX-5613 was generally well-tolerated, with no discontinuations
due to treatment-related adverse events observed in heavily
pretreated patients.
Syndax remains on track to initiate the pivotal Phase 2 portion
of the trial this quarter.
Axatilimab
Syndax today announced that enrollment is now complete in the
Phase 2 expansion portion of the Phase 1/2 trial of axatilimab, its
anti-CSF-1R monoclonal antibody, in patients with cGVHD. The
Company anticipates reporting updated results later this year for
40 patients, including the 17 in the Phase 1 portion and 23 from
the Phase 2 expansion portion, which evaluated 1 mg/kg of
axatilimab every two weeks. Syndax reported preliminary data from
the Phase 1 portion of the trial during an oral presentation
at the American Society of Hematology Annual Meeting in
December 2020 which highlighted the
tolerability and high response rate of axatilimab in cGVHD patients
refractory to multiple therapeutic agents.
The Company's pivotal Phase 2 AGAVE-201 trial of axatilimab in
patients with cGVHD is ongoing, with topline data expected in 2023.
The trial will evaluate the safety and efficacy of three doses and
schedules of axatilimab. The primary endpoint will assess objective
response rate based on the 2014 NIH consensus criteria for cGVHD,
with key secondary endpoints including duration of response and
improvement in modified Lee Symptom Scale score.
Earlier this year, the Company announced that the U.S. Food and
Drug Administration granted Orphan Drug Designation to axatilimab
for the treatment of patients with cGVHD and idiopathic
pulmonary fibrosis.
First Quarter 2021 Financial Results
As of March 31, 2021, Syndax had cash, cash equivalents and
short-term investments of $271.3 million and 51.6 million
shares and share equivalents issued and outstanding. This includes
3.3 million pre-funded warrants.
First quarter 2021 research and development expenses increased
to $21.9 million from $9.6 million. The increase was primarily due to
increased clinical trial activities and increased CMC
activities.
General and administrative expenses for the first quarter 2021
decreased to $5.7 million from
$5.9 million. The decrease is
primarily due to decreased pre-commercialization expenses for
entinostat.
For the three months ended March 31,
2021, Syndax reported a net loss attributable to common
stockholders of $27.7 million or
$0.54 per share compared to
$19.1 million or $0.56 per share for the prior year period.
Financial Update and Guidance
For the second quarter of 2021, research and development
expenses are expected to be $30 to
$35 million, and total operating
expenses are expected to be $35 to
$40 million. For the full year of
2021, research and development expenses are expected to be
$90 to $100
million, and total operating expenses are expected to be
$110 to $120
million.
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, May 11, 2021.
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: 8178876
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/4gwngoxq
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 pipeline includes SNDX-5613, a highly selective inhibitor
of the Menin–MLL binding interaction for the treatment of
genetically-defined leukemias; axatilimab, a monoclonal antibody
that blocks the colony stimulating factor 1 (CSF-1) receptor; and
entinostat, a class I HDAC inhibitor.
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
design, progress, timing, clinical development and scope of
clinical trials, plans for initiating future clinical trials,
reporting of clinical data for Syndax's product candidates, the
association of data with treatment outcomes, the potential use of
our product candidates to treat various cancer indications and
fibrotic diseases, Syndax's expected second quarter and full year
research and development expenses, and expected total operating
expenses. 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, the COVID-19 pandemic may disrupt
our business and that of the third parties on which we depend,
including delaying or otherwise disrupting our clinical trials and
preclinical studies, manufacturing and supply chain, or impairing
employee productivity, 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 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
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
(In
thousands)
|
2021
|
|
2020
|
Cash, cash
equivalents and short-term investments
|
$
271,335
|
|
$
293,065
|
Total
assets
|
$
279,672
|
|
$
300,613
|
Total
liabilities
|
$
51,467
|
|
$
48,425
|
Total stockholders'
equity (deficit)
|
$
228,205
|
|
$
252,188
|
|
|
|
|
|
|
Common stock
outstanding
|
48,248,559
|
|
47,881,223
|
Common stock and
common stock equivalents*
|
59,085,417
|
|
57,836,910
|
|
|
|
|
|
|
*Common stock and
common stock equivalents:
|
|
|
|
|
Common
stock
|
48,248,559
|
|
47,881,223
|
|
Options to purchase
common stock
|
7,404,823
|
|
6,379,235
|
|
Restricted Stock
Units
|
124,083
|
|
18,500
|
|
Pre-funded
warrants
|
3,307,952
|
|
3,557,952
|
|
|
|
59,085,417
|
|
57,836,910
|
|
|
|
|
|
|
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
(In thousands,
except share and per share data)
|
2021
|
|
2020
|
License fee
revenue
|
$
379
|
|
$
379
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
21,870
|
|
9,562
|
|
General and
administrative
|
5,672
|
|
5,917
|
Total operating
expenses
|
27,542
|
|
15,479
|
Loss from
operations
|
(27,163)
|
|
(15,100)
|
Other income
(expense), net
|
(560)
|
|
(136)
|
Net
loss
|
$
(27,723)
|
|
$
(15,236)
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(27,723)
|
|
$
(19,142)
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
stockholders--basic
and diluted
|
$
(0.54)
|
|
$
(0.56)
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
used to compute net
loss per share attributable
|
|
|
|
|
to common
stockholders--basic and diluted
|
51,499,831
|
|
34,328,640
|
|
|
|
|
|
|
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SOURCE Syndax Pharmaceuticals, Inc.