05 May 2020
"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
Entinostat
SNDX-5613
Axatilimab
Financial Update and Guidance
As of
In
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
In February 2020, the Company entered into an agreement with
First quarter 2020 research and development expenses decreased to
General and administrative expenses for the first quarter 2020 increased to
For the three months ended
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
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, 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 |
|||||
|
|
||||
(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 |
|||||
(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 |
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