WALTHAM, Mass., March 8, 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 fourth quarter ended December 31, 2020. In addition, the Company
provided a clinical and business update.
"We expect 2021 will be a year of immense progress across our
two highly promising programs aimed at addressing key areas of
unmet need, coupled with a sharp focus on pipeline expansion," said
Briggs W. Morrison, M.D., Chief
Executive Officer of Syndax. "Notably, we plan to present data from
the Phase 1 portion of our ongoing AUGMENT-101 trial of SNDX-5613,
our selective menin inhibitor, in patients with acute leukemias. We
presented promising initial clinical data at the 2020 AACR Annual
Meeting that provided the first clinical evidence that disrupting
the interaction between menin and MLL1 can induce rapid responses
in difficult to treat acute leukemias. We look forward to sharing
updated results which further expand on SNDX-5613's potential to
meaningfully alter the treatment paradigm in genetically-defined
acute leukemias."
"Additionally, on the heels of positive data presented at the
ASH Annual Meeting in December from our Phase 1 trial of
axatilimab, our anti-CSF-1R monoclonal antibody, in patients with
cGVHD, we are pleased to announce that our pivotal Phase 2
AGAVE-101 trial is now underway. Through inhibition of monocyte
derived macrophages, axatilimab has demonstrated important clinical
benefits in multiple organ systems. We believe axatilimab could
represent a meaningful therapeutic option for additional fibrotic
diseases where macrophages have been shown to play a significant
role, and we are actively exploring additional indications."
Recent Progress and Anticipated Milestones
SNDX-5613
Syndax plans to share data from the Phase 1 AUGMENT-101 trial of
SNDX-5613, its highly selective, oral menin inhibitor, in patients
with mixed lineage leukemia rearranged (MLL-r) and nucleophosmin
(NPM1) mutant acute leukemias late in the first quarter or early in
the second quarter of 2021. Additional details regarding the
presentation, which will feature the trial's principal
investigator, 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, will be announced in the coming weeks. The
Company remains on track to initiate the Phase 2 portion of the
trial in the second quarter of 2021, which could potentially serve
as the basis for a regulatory filing.
Axatilimab
At the 62nd American Society of Hematology (ASH)
Annual Meeting and Exposition in December
2020, Syndax reported updated data from its Phase 1 trial of
axatilimab, its anti-CSF-1R monoclonal antibody, in patients with
chronic graft versus host disease (cGVHD). Data demonstrated deep,
durable responses and multiorgan clinical benefit in patients
refractory to multiple therapeutic agents.
The Company announced today that the pivotal Phase 2 AGAVE-201
trial, which will evaluate the safety and efficacy of three doses
and schedules of axatilimab in patients with cGVHD, began enrolling
patients earlier this quarter. The primary endpoint will assess
objective response rate based on the 2014 NIH consensus criteria
for GVHD, with key secondary endpoints including duration of
response and improvement in modified Lee Symptom Scale score. The
Company expects to report topline data in 2023.
Fourth Quarter 2020 Financial Results
As of December 31, 2020, Syndax had cash, cash equivalents
and short-term investments of $293.1 million and 51.4 million
shares and share equivalents issued and outstanding. This includes
3.6 million pre-funded warrants.
Fourth quarter 2020 research and development expenses increased
to $15.5 million from $9.5 million, and for the full year increased to
$50.4 million compared to
$43.0 million for 2019. The fourth
quarter and full year increases were primarily due to increased
clinical trial activities, increased CMC activities and
professional fees.
General and administrative expenses for the fourth quarter 2020
decreased to $4.7 million from
$5.1 million, and, for the year ended
December 31, 2020, increased to
$22.5 million compared to
$16.1 million for the prior year. The
fourth quarter decrease is primarily due to decreased
pre-commercialization expenses. The increase for the full year was
primarily due to increased professional fees and employee related
expenses.
For the three months ended December 31,
2020, Syndax reported a net loss attributable to common
stockholders of $20.4 million or
$0.44 per share compared to
$14.0 million or $0.44 per share for the prior year period. For
the year ended December 31, 2020,
Syndax reported a net loss attributable to common stockholders of
$77.8 million or $1.88 per share, compared to $56.0 million or $1.84 per share for the prior year. For the year
ended December 31, 2020, this
includes a deemed dividend of $3.9
million.
Financial Update and Guidance
In December 2020, Syndax issued
6,250,000 shares of its common stock at $23.00 per share. As a result of the offering,
Syndax received gross proceeds of approximately $143.8 million.
For the first quarter of 2021, research and development expenses
are expected to be $25 to
$30 million, and total operating
expenses are expected to be $30 to
$35 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, Monday, March 8, 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: 7949816
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/wdaqmgg3
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, 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
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 2020 net cash
used in research and development and total operating activities,
and first quarter and full year 2021 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, 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
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SYNDAX
PHARMACEUTICALS, INC.
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(unaudited)
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CONDENSED
CONSOLIDATED BALANCE SHEETS
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December
31,
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(In
thousands)
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2020
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|
2019
|
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|
Cash, cash
equivalents and short-term investments
|
$
293,065
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$
59,775
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Total
assets
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$
300,613
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$
63,525
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Total
liabilities
|
$
48,425
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$
31,925
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Total stockholders'
equity (deficit)
|
$
252,188
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$
31,600
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Common stock
outstanding
|
47,881,223
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27,140,484
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Common stock and
common stock equivalents*
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57,836,910
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42,292,534
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*Common stock and
common stock equivalents:
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Common
stock
|
47,881,223
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27,140,484
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Options to purchase
common stock
|
6,379,235
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|
6,057,011
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Restricted Stock
Units
|
18,500
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|
-
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Series 1 and 2
warrants
|
-
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|
4,595,039
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Pre-funded
warrants
|
3,557,952
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|
4,500,000
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57,836,910
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42,292,534
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SYNDAX
PHARMACEUTICALS, INC.
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(unaudited)
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended
December 31,
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Year Ended
December 31,
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(In thousands,
except share and per share data)
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2020
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2019
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2020
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2019
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License fee
revenue
|
$
380
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$
380
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$
1,517
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$
1,517
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Operating
expenses:
|
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Research and
development
|
15,522
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9,502
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|
50,435
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42,994
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General and
administrative
|
4,718
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|
5,083
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|
22,505
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16,062
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Total operating
expenses
|
20,240
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|
14,585
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|
72,940
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|
59,056
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Loss from
operations
|
(19,860)
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(14,205)
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(71,423)
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(57,539)
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Other income
(expense), net
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(563)
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|
205
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(1,735)
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|
1,492
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Net
loss
|
$
(20,423)
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$
(14,000)
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$
(73,158)
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$
(56,047)
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Net loss attributable
to common stockholders
|
$
(20,423)
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$
(14,000)
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$
(77,064)
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$
(56,047)
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Net loss per share
attributable to common
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|
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stockholders--basic and
diluted
|
$
(0.44)
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$
(0.44)
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$
(1.87)
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$
(1.84)
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Weighted-average
number of common stock
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used to compute net
loss per share attributable
|
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to common
stockholders--basic and diluted
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46,054,850
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31,640,484
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41,308,242
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|
30,490,783
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View original
content:http://www.prnewswire.com/news-releases/syndax-pharmaceuticals-reports-fourth-quarter-2020-financial-results-and-provides-clinical-and-business-update-301242684.html
SOURCE Syndax Pharmaceuticals, Inc.