11 May 2021
"We are excited to provide an update on the positive interim Phase 1 data from the ongoing AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant acute leukemias," said
"In addition, we continue to make progress with axatilimab in patients with chronic graft versus host disease (cGVHD). We are pleased to announce today that we have completed enrollment of 23 patients in the Phase 2 expansion portion of the Phase 1/2 trial. We look forward to sharing full updated results from the Phase 1/2 trial later this year, with top-line data from the ongoing pivotal AGAVE-201 trial expected in 2023. Supported by emerging data, we firmly believe that axatilimab has the potential to benefit many of the more than 10,000 patients diagnosed with cGVHD in the
The Company today announced new data from the ongoing Phase 1 dose escalation portion of the Phase 1/2 AUGMENT-101 trial of SNDX-5613, a highly selective oral menin inhibitor, in patients with MLLr and NPM1c mutant relapsed/refractory (R/R) acute leukemias. The new data reported today, showed two prior responders have improved from CRp to CR with no evidence of minimal residual disease (MRD-). With the addition of these two patients, a total of 7/31 patients (23%) have achieved CR/CRh.
Syndax previously announced positive data from the Phase 1 portion of the AUGMENT-101 trial in
Syndax remains on track to initiate the pivotal Phase 2 portion of the trial this quarter.
Syndax today announced that enrollment is now complete in the Phase 2 expansion portion of the Phase 1/2 trial of axatilimab, its anti-CSF-1R monoclonal antibody, in patients with cGVHD. The Company anticipates reporting updated results later this year for 40 patients, including the 17 in the Phase 1 portion and 23 from the Phase 2 expansion portion, which evaluated 1 mg/kg of axatilimab every two weeks. Syndax reported preliminary data from the Phase 1 portion of the trial during an oral presentation at the
The Company's pivotal Phase 2 AGAVE-201 trial of axatilimab in patients with cGVHD is ongoing, with topline data expected in 2023. The trial will evaluate the safety and efficacy of three doses and schedules of axatilimab. The primary endpoint will assess objective response rate based on the 2014
Earlier this year, the Company announced that the
As of March 31, 2021, Syndax had cash, cash equivalents and short-term investments of $271.3 million and 51.6 million shares and share equivalents issued and outstanding. This includes 3.3 million pre-funded warrants.
First quarter 2021 research and development expenses increased to
General and administrative expenses for the first quarter 2021 decreased to
For the three months ended
For the second quarter of 2021, 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 design, progress, timing, clinical development and scope of clinical trials, plans for initiating future clinical trials, reporting of clinical data for Syndax's product candidates, the association of data with treatment outcomes, the potential use of our product candidates to treat various cancer indications and fibrotic diseases, Syndax's expected second quarter and full year 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
SNDX-G
SYNDAX PHARMACEUTICALS, INC. |
|||||
(unaudited) |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
|
|
||||
(In thousands) |
2021 |
2020 |
|||
Cash, cash equivalents and short-term investments |
$ 271,335 |
$ 293,065 |
|||
Total assets |
$ 279,672 |
$ 300,613 |
|||
Total liabilities |
$ 51,467 |
$ 48,425 |
|||
Total stockholders' equity (deficit) |
$ 228,205 |
$ 252,188 |
|||
Common stock outstanding |
48,248,559 |
47,881,223 |
|||
Common stock and common stock equivalents* |
59,085,417 |
57,836,910 |
|||
*Common stock and common stock equivalents: |
|||||
Common stock |
48,248,559 |
47,881,223 |
|||
Options to purchase common stock |
7,404,823 |
6,379,235 |
|||
Restricted Stock Units |
124,083 |
18,500 |
|||
Pre-funded warrants |
3,307,952 |
3,557,952 |
|||
59,085,417 |
57,836,910 |
SYNDAX PHARMACEUTICALS, INC. |
|||||
(unaudited) |
|||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||
Three Months Ended |
|||||
(In thousands, except share and per share data) |
2021 |
2020 |
|||
License fee revenue |
$ 379 |
$ 379 |
|||
Operating expenses: |
|||||
Research and development |
21,870 |
9,562 |
|||
General and administrative |
5,672 |
5,917 |
|||
Total operating expenses |
27,542 |
15,479 |
|||
Loss from operations |
(27,163) |
(15,100) |
|||
Other income (expense), net |
(560) |
(136) |
|||
Net loss |
$ (27,723) |
$ (15,236) |
|||
Net loss attributable to common stockholders |
$ (27,723) |
$ (19,142) |
|||
Net loss per share attributable to common |
|||||
stockholders--basic and diluted |
$ (0.54) |
$ (0.56) |
|||
Weighted-average number of common stock |
|||||
used to compute net loss per share attributable |
|||||
to common stockholders--basic and diluted |
51,499,831 |
34,328,640 |
|||
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