07 August 2019
"The
Dr. Morrison added, "We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the
In
The Company continues to anticipate the final E2112 interim OS analysis in 4Q19. If necessary, the final OS assessment, which will be triggered when the trial reaches a total of 410 death events, is expected to be conducted in 2Q20. A positive OS assessment at any point would enable the Company to file for full regulatory approval. 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+, HER2- breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a strong OS benefit.
In
Enrollment continues in the Phase 1 dose escalation trial of SNDX-6352, Syndax's anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). The Company now anticipates results from this trial in the second half of 2020. The objectives of this trial are to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.
Syndax announced the appointment of
As of
Second quarter 2019 research and development expenses decreased to
General and administrative expenses for the second quarter 2019 decreased to
For the three months ended
Today the Company provided operating expense guidance for the third quarter and full year 2019. For the third quarter and full year 2019, research and development expenses are expected to be
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 operating expense guidance for the third quarter and full year 2019. 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) |
2019 |
2018 |
|||
Cash, cash equivalents, short-term and long-term investments |
$ 80,520 |
$ 80,911 |
|||
Total assets |
$ 87,390 |
$ 83,938 |
|||
Total liabilities |
$ 32,115 |
$ 30,891 |
|||
Total stockholders' equity (deficit) |
$ 55,275 |
$ 53,047 |
|||
Common stock outstanding |
27,117,946 |
24,835,951 |
|||
Common stock and common stock equivalents* |
41,983,601 |
31,088,934 |
|||
*Common stock and common stock equivalents: |
|||||
Common stock |
27,117,946 |
24,835,951 |
|||
Common stock warrants (pre-funded) |
4,500,000 |
2,000,000 |
|||
Common stock and pre-funded stock warrants |
31,617,946 |
26,835,951 |
|||
Options to purchase common stock |
5,770,616 |
4,252,983 |
|||
Common stock warrants (series 1 and 2) |
4,595,039 |
- |
|||
Total common stock and common stock equivalents |
41,983,601 |
31,088,934 |
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) |
2019 |
2018 |
2019 |
2018 |
|||||
License fee revenue |
$ 379 |
$ 379 |
$ 758 |
$ 758 |
|||||
Operating expenses: |
|||||||||
Research and development |
12,290 |
14,851 |
23,569 |
30,190 |
|||||
General and administrative |
3,463 |
4,479 |
7,374 |
9,270 |
|||||
Total operating expenses |
15,753 |
19,330 |
30,943 |
39,460 |
|||||
Loss from operations |
(15,374) |
(18,951) |
(30,185) |
(38,702) |
|||||
Other income, net |
458 |
563 |
967 |
917 |
|||||
Net loss |
$ (14,916) |
$ (18,388) |
$ (29,218) |
$ (37,785) |
|||||
Net loss attributable to common stockholders |
$ (14,916) |
$ (18,388) |
$ (29,218) |
$ (37,785) |
|||||
Net loss per share attributable to common |
|||||||||
stockholders--basic and diluted |
$ (0.47) |
$ (0.74) |
$ (1.00) |
$ (1.54) |
|||||
Weighted-average number of common stock |
|||||||||
used to compute net loss per share attributable |
|||||||||
to common stockholders--basic and diluted |
31,605,279 |
24,705,441 |
29,327,029 |
24,592,483 |
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