WALTHAM, Mass., May 7, 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 first quarter ended March 31, 2020. In addition, the Company provided
a clinical and business update.
"During the first quarter, we generated significant momentum
that we believe will take us through what we expect will be a
transformational year for Syndax, with key data readouts expected
across the entirety of our portfolio," said Briggs W. Morrison, M.D., Chief Executive
Officer of Syndax. "We continue to anticipate the final overall
survival readout from E2112, our Phase 3 registration trial of
entinostat plus exemestane in HR+, HER2- breast cancer later this
quarter, with a potential regulatory filing for entinostat in HR+
breast cancer by year end. 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. While we await this final readout, we remain focused on
preparations to establish ourselves as a fully integrated oncology
company, with a potential launch expected in 2021."
Dr. Morrison added, "Beyond entinostat, we were pleased to
recently announce initial Phase 1 data from the AUGMENT-101 trial
of SNDX-5613, our oral menin inhibitor, in adults with
relapsed/refractory acute leukemias. These data provide the first
clinical evidence that inhibition of the menin-MLL1 interaction can
induce response in patients with MLL-r acute leukemias. We believe
that SNDX-5613 has great potential to serve as an effective
intervention for both MLL-r acute leukemias and NPM1 mutant AML,
and we look forward to presenting additional data from this trial
in the fourth quarter of this year. With a strong balance sheet,
which includes proceeds from our recent follow-on offering, we
believe we are well positioned to execute on upcoming
milestones."
Pipeline Updates
Entinostat
- Syndax continues to anticipate that the E2112 trial will reach
410 death events this quarter, 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 initial clinical data from the
Phase 1 portion of its ongoing open-label Phase 1/2 AUGMENT-101
trial of SNDX-5613, the Company's potent, highly selective oral
menin inhibitor. Data presented serve as the first clinical
evidence that inhibition of the menin-MLL1 interaction can induce
response in patients with mixed lineage leukemia rearranged (MLL-r)
acute leukemias. The presentation, which was featured at the 2020
American Association for Cancer Research (AACR) Virtual Annual
Meeting I, also highlighted preclinical findings, including data
recently published in Cancer Cell
and Science magazine, supporting the potential of
single-agent menin-MLL inhibition to serve as an effective
intervention for both MLL-r acute leukemias and nucleophosmin
(NPM1) mutant acute myeloid leukemia (AML). A copy of the
presentation is available on Syndax's website under Publications,
Menin-MLLR Inhibitors.
The AUGMENT-101 trial is a Phase 1/2 open-label trial designed to
evaluate the safety, tolerability, pharmacokinetics and efficacy of
orally administered SNDX-5613. The Phase 1 dose escalation portion
of AUGMENT-101 was recently separated into two cohorts based on
concomitant treatment with a strong CYP3A4 inhibitor. Arm A will
enroll patients not receiving a strong CYP3A4 inhibitor, while Arm
B will enroll patients receiving a strong CYP3A4 inhibitor. The
Phase 1 dose escalation portion of AUGMENT-101 is currently
enrolling adults with relapsed/refractory acute leukemias including
MLL-r and NPM1 mutant acute leukemias and is expected to establish
a recommended Phase 2 dose for both cohorts by the fourth quarter
of 2020. 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 acute
lymphoblastic leukemia (ALL), MLL-r AML and NPM1 mutant AML. The
Company expects to present additional results from AUGMENT-101 at a
medical conference in the fourth quarter of 2020.
- The Company recently announced that SNDX-5613 was granted
Orphan Drug Designation for the treatment of adult and pediatric
AML by the U.S. Food and Drug Administration (FDA).
Axatilimab
- Enrollment continues across the Company's Phase 1/2 trial
evaluating axatilimab, its anti-CSF-1R monoclonal antibody, for the
treatment of chronic graft versus host disease (cGVHD). The Phase 1
portion continues to explore alternate dose and schedules, while
the Phase 2 expansion is evaluating the benefit of treatment at 1
mg/kg every two weeks. The Company expects to present additional
results from the Phase 1/2 trial in the fourth quarter of
2020.
- Data from the Phase 1 trials exploring axatilimab, both as a
monotherapy and in combination with IMFINZI®
(durvalumab) in patients with locally-advanced or metastatic solid
tumors, were summarized in two oral presentations at the AACR
Virtual Annual Meeting I. The data indicate that axatilimab is
tolerated well in solid tumor patients and provide evidence of its
ability to deplete circulating pro-inflammatory monocytes. A
recommended Phase 2 dose of axatilimab for the treatment of
patients with solid tumors was determined as monotherapy and in
combination with IMFINZI® (durvalumab). A copy of each
presentation is available on Syndax's website under Publications,
Axatilimab.
Financial Update and Guidance
As of March 31, 2020, Syndax had
cash, cash equivalents and short-term investments of $99.0 million and 36.1 million shares and share
equivalents issued and outstanding which included 30.2 million
shares of common stock and pre-funded warrants to purchase 5.8
million shares of common stock.
In May 2020, Syndax closed an
underwritten public offering whereby the Company sold 5,555,556
shares of common stock at a price of $18.00 per share. The aggregate net proceeds
received by the Company were $93.7
million, net of underwriting discounts and commissions and
estimated offering expenses payable by the Company. The offering
allows for an additional 833,333 shares to be issued pursuant to
the underwriters' exercise of their option to purchase additional
shares of common stock.
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
$34.9 million.
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
First quarter 2020 research and development expenses decreased
to $9.6 million from $11.3 million for the prior year period. The
first quarter decrease was primarily due to reduced CMC activities
and a net decrease in clinical activities.
General and administrative expenses for the first quarter 2020
increased to $5.9 million from
$3.9 million for the prior year
period. The increase was primarily due to increased
pre-commercialization expenses and increased employee related
expenses.
For the three months ended March 31,
2020, Syndax reported a net loss attributable to common
stockholders of $19.1 million or
$0.56 per share compared to
$14.3 million or $0.53 per share for the prior year period.
Financial Guidance
Today the Company provided operating expense guidance for the
second quarter of 2020. Financial guidance for the second half of
2020 will be issued after the Company announces the result of the
E2112 study. The Company expects operating expenses for the second
quarter of 2020 to increase over the quarterly operating expenses
reported for the first quarter of 2020. Research and development
(R&D) expenses will increase, primarily due to increased
development activities for SNDX-5613. Second quarter G&A
expenses are expected to be similar to the first quarter G&A
expenses. For the second quarter of 2020, R&D expenses are
expected to be $12 to $14 million, and total operating
expenses are expected to be $18 to $20 million. Given its
cash operating expense guidance, the Company expects to end the
second quarter of 2020 with approximately $175 million of cash, which provides the
financial flexibility to take advantage of key development
milestones.
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, May 7, 2020.
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: 5579109
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/pnyq8m58
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 axatilimab (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 expected second quarter 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
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
(In
thousands)
|
2020
|
|
2019
|
Cash, cash
equivalents and short-term investments
|
$
99,005
|
|
$
59,775
|
Total
assets
|
$
105,155
|
|
$
63,525
|
Total
liabilities
|
$
51,646
|
|
$
31,925
|
Total stockholders'
equity (deficit)
|
$
53,509
|
|
$
31,600
|
|
|
|
|
|
|
Common stock
outstanding
|
27,140,484
|
|
27,140,484
|
Common stock and
common stock equivalents*
|
47,571,966
|
|
42,292,534
|
|
|
|
|
|
|
*Common stock and
common stock equivalents:
|
|
|
|
|
Common
stock
|
30,240,838
|
|
27,140,484
|
|
Common stock warrants
(pre-funded)
|
5,838,287
|
|
4,500,000
|
|
|
Common stock and
pre-funded stock warrants
|
36,079,125
|
|
31,640,484
|
|
Options to purchase
common stock
|
6,897,802
|
|
6,057,011
|
|
Series 1 and 2
warrants
|
4,595,039
|
|
4,595,039
|
|
|
Total common stock
and common stock equivalents
|
47,571,966
|
|
42,292,534
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SYNDAX
PHARMACEUTICALS, INC.
|
(unaudited)
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
(In thousands,
except share and per share data)
|
2020
|
|
2019
|
License fee
revenue
|
$
379
|
|
$
379
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
9,562
|
|
11,279
|
|
General and
administrative
|
5,917
|
|
3,911
|
Total operating
expenses
|
15,479
|
|
15,190
|
Loss from
operations
|
(15,100)
|
|
(14,811)
|
Other (expense)
income, net
|
(136)
|
|
509
|
Net
loss
|
$
(15,236)
|
|
$
(14,302)
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(19,142)
|
|
$
(14,302)
|
|
|
|
|
|
|
Net loss per share
attributable to common
|
|
|
|
|
stockholders--basic
and diluted
|
$
(0.56)
|
|
$
(0.53)
|
|
|
|
|
|
|
Weighted-average
number of common stock
|
|
|
|
|
used to compute net
loss per share attributable
|
|
|
|
|
to common
stockholders--basic and diluted
|
34,328,640
|
|
27,023,466
|
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
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SOURCE Syndax Pharmaceuticals, Inc.