10 August 2017
- PD-1 Refractory Melanoma Cohort of ENCORE 601 Completes Enrollment -
- First Patient Dosed in ENCORE 601 Colorectal Cancer Cohort -
WALTHAM, Mass.,
Enrollment in all cohorts of ENCORE 601 have proceeded rapidly. The second stage of the ENCORE 601 cohort enrolling PD-1 (programmed death receptor-1) refractory melanoma patients has reached its accrual target. Enrollment in the PD-1 refractory non-small cell lung cancer (NSCLC) cohort remains on track, and is expected to be complete in the fourth quarter. The Company also announced that the first patient has been dosed in the ENCORE 601 cohort enrolling microsatellite stable colorectal cancer (CRC) patients.
"The second quarter was marked by continued progress across our clinical pipeline. The initial results from ENCORE 601 provide the first clinical evidence that entinostat may reverse resistance to immune checkpoint therapies," said
Pipeline Updates
Syndax Expects to Participate in the Following Upcoming Investor Conferences
Second Quarter 2017 Financial Results
As of
Second quarter 2017 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 2017. For the third quarter and full year 2017, research and development expenses are expected to be
About
Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the
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, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, 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 STATEMENTS OF OPERATIONS DATA |
|||||||||
Three Months Ended |
Six Months Ended |
||||||||
(In thousands, except share and per share data) |
2017 |
2016 |
2017 |
2016 |
|||||
License fee revenue |
$ 305 |
$ 305 |
$ 610 |
$ 610 |
|||||
Operating expenses: |
|||||||||
Research and development |
9,862 |
6,131 |
19,414 |
10,917 |
|||||
General and administrative |
4,285 |
2,808 |
8,215 |
7,080 |
|||||
Total operating expenses |
14,147 |
8,939 |
27,629 |
17,997 |
|||||
Loss from operations |
(13,842) |
(8,634) |
(27,019) |
(17,387) |
|||||
Other income (expense), net |
203 |
276 |
409 |
(1,301) |
|||||
Net loss |
$ (13,639) |
$ (8,358) |
$ (26,610) |
$ (18,688) |
|||||
Net loss attributable to common stockholders |
$ (13,639) |
$ (8,358) |
$ (26,610) |
$ (21,286) |
|||||
Net loss per share attributable to common |
|||||||||
stockholders--basic and diluted |
$ (0.70) |
$ (0.47) |
$ (1.41) |
$ (1.91) |
|||||
Weighted-average number of common stock |
|||||||||
used to compute net loss per share attributable |
|||||||||
to common stockholders--basic and diluted |
19,497,581 |
17,769,514 |
18,868,089 |
11,155,525 |
|
|||||
(unaudited) |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS DATA |
|||||
(In thousands) |
|
|
|||
ASSETS |
|||||
Cash, cash equivalents, and short-term investments |
$ 129,955 |
$ 105,330 |
|||
Other assets |
4,711 |
3,683 |
|||
Total assets |
$ 134,666 |
$ 109,013 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
$ 11,505 |
$ 10,366 |
|||
Deferred revenue, less current portion |
13,610 |
14,220 |
|||
Other liabilities |
214 |
288 |
|||
Total liabilities |
25,329 |
24,874 |
|||
Total stockholders' equity |
109,337 |
84,139 |
|||
Total liabilities and stockholders' equity |
$ 134,666 |
$ 109,013 |
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