07 August 2018
"We made great progress across multiple programs during the first half of this year, including presentation of data from all three cohorts of ENCORE 601 and completion of target enrollment in ENCORE 602 and 603. We also initiated the first combination trial for the SNDX-6352 program, which will evaluate its safety in combination with durvalumab (IMFINZI®)," said
The Company also announced today that it plans to initiate a Phase 1 trial of its monoclonal antibody inhibitor of Colony-Stimulating Factor 1 Receptor (CSF-1R), SNDX-6352, in patients with chronic graft versus host disease (cGVHD). Enrollment in this trial is anticipated to begin by the end of the year, with initial data expected in the second half of 2019.
"We are excited to begin the evaluation of SNDX-6352 as a treatment for cGVHD, a novel clinical path for a CSF1-R inhibitor," said
Pipeline Updates
Second Quarter 2018 Financial Results
As of
On
In the third quarter of 2018, through
Second quarter 2018 research and development expenses increased to
General and administrative expenses totaled
For the three months ended
Financial Guidance
Today the Company provided operating expense guidance for the third quarter and full year 2018. For the third quarter and full year 2018, research and development expenses are expected to be
About
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, and Syndax's second quarter and full-year 2018 net cash used in research and development and total operating activities. 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
SYNDAX PHARMACEUTICALS, INC. |
|||||||||
(unaudited) |
|||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||||
June 30, |
December 31, |
||||||||
(In thousands) |
2018 |
2017 |
|||||||
Cash, cash equivalents, short-term and long-term investments |
$ 98,385 |
$ 133,220 |
|||||||
Total assets |
$ 105,370 |
$ 137,186 |
|||||||
Total liabilities |
$ 35,018 |
$ 32,867 |
|||||||
Total stockholders' equity |
$ 70,352 |
$ 104,319 |
|||||||
Common stock outstanding |
22,705,794 |
24,390,033 |
|||||||
Common stock and common stock equivalents* |
28,938,384 |
28,139,705 |
|||||||
*Common stock and common stock equivalents: |
|||||||||
Common stock |
22,705,794 |
24,390,033 |
|||||||
Options to purchase common stock |
4,232,590 |
3,391,832 |
|||||||
Common stock warrants |
2,000,000 |
357,840 |
|||||||
28,938,384 |
28,139,705 |
||||||||
SYNDAX PHARMACEUTICALS, INC. |
|||||||||
(unaudited) |
|||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||
(In thousands, except share and per share data) |
2018 |
2017 |
2018 |
2017 |
|||||
License fee revenue |
$ 379 |
$ 305 |
$ 758 |
$ 610 |
|||||
Operating expenses: |
|||||||||
Research and development |
14,851 |
9,862 |
30,190 |
19,414 |
|||||
General and administrative |
4,479 |
4,285 |
9,270 |
8,215 |
|||||
Total operating expenses |
19,330 |
14,147 |
39,460 |
27,629 |
|||||
Loss from operations |
(18,951) |
(13,842) |
(38,702) |
(27,019) |
|||||
Other income, net |
563 |
203 |
917 |
409 |
|||||
Net loss |
$ (18,388) |
$ (13,639) |
$ (37,785) |
$ (26,610) |
|||||
Net loss attributable to common stockholders |
$ (18,388) |
$ (13,639) |
$ (37,785) |
$ (26,610) |
|||||
Net loss per share attributable to common |
|||||||||
stockholders--basic and diluted |
$ (0.74) |
$ (0.70) |
$ (1.54) |
$ (1.41) |
|||||
Weighted-average number of common stock |
|||||||||
used to compute net loss per share attributable |
|||||||||
to common stockholders--basic and diluted |
24,705,441 |
19,497,581 |
24,592,483 |
18,868,089 |
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