08 March 2021
"We expect 2021 will be a year of immense progress across our two highly promising programs aimed at addressing key areas of unmet need, coupled with a sharp focus on pipeline expansion," said
"Additionally, on the heels of positive data presented at the ASH Annual Meeting in December from our Phase 1 trial of axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD, we are pleased to announce that our pivotal Phase 2 AGAVE-101 trial is now underway. Through inhibition of monocyte derived macrophages, axatilimab has demonstrated important clinical benefits in multiple organ systems. We believe axatilimab could represent a meaningful therapeutic option for additional fibrotic diseases where macrophages have been shown to play a significant role, and we are actively exploring additional indications."
SNDX-5613
Syndax plans to share data from the Phase 1 AUGMENT-101 trial of SNDX-5613, its highly selective, oral menin inhibitor, in patients with mixed lineage leukemia rearranged (MLL-r) and nucleophosmin (NPM1) mutant acute leukemias late in the first quarter or early in the second quarter of 2021. Additional details regarding the presentation, which will feature the trial's principal investigator,
Axatilimab
At the 62nd
The Company announced today that the pivotal Phase 2 AGAVE-201 trial, which will evaluate the safety and efficacy of three doses and schedules of axatilimab in patients with cGVHD, began enrolling patients earlier this quarter. The primary endpoint will assess objective response rate based on the 2014
As of December 31, 2020, Syndax had cash, cash equivalents and short-term investments of $293.1 million and 51.4 million shares and share equivalents issued and outstanding. This includes 3.6 million pre-funded warrants.
Fourth quarter 2020 research and development expenses increased to
General and administrative expenses for the fourth quarter 2020 decreased to
For the three months ended
In
For the first quarter of 2021, research and development expenses are expected to be
For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com.
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 fourth quarter and full-year 2020 net cash used in research and development and total operating activities, and first quarter and full year 2021 operating expense and cash guidance. 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
SYNDAX PHARMACEUTICALS, INC. |
||||||||||
(unaudited) |
||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||||
|
||||||||||
(In thousands) |
2020 |
2019 |
||||||||
Cash, cash equivalents and short-term investments |
$ 293,065 |
$ 59,775 |
||||||||
Total assets |
$ 300,613 |
$ 63,525 |
||||||||
Total liabilities |
$ 48,425 |
$ 31,925 |
||||||||
Total stockholders' equity (deficit) |
$ 252,188 |
$ 31,600 |
||||||||
Common stock outstanding |
47,881,223 |
27,140,484 |
||||||||
Common stock and common stock equivalents* |
57,836,910 |
42,292,534 |
||||||||
*Common stock and common stock equivalents: |
||||||||||
Common stock |
47,881,223 |
27,140,484 |
||||||||
Options to purchase common stock |
6,379,235 |
6,057,011 |
||||||||
Restricted Stock Units |
18,500 |
- |
||||||||
Series 1 and 2 warrants |
- |
4,595,039 |
||||||||
Pre-funded warrants |
3,557,952 |
4,500,000 |
||||||||
57,836,910 |
42,292,534 |
|||||||||
SYNDAX PHARMACEUTICALS, INC. |
||||||||||
(unaudited) |
||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||
Three Months Ended |
Year Ended |
|||||||||
(In thousands, except share and per share data) |
2020 |
2019 |
2020 |
2019 |
||||||
License fee revenue |
$ 380 |
$ 380 |
$ 1,517 |
$ 1,517 |
||||||
Operating expenses: |
||||||||||
Research and development |
15,522 |
9,502 |
50,435 |
42,994 |
||||||
General and administrative |
4,718 |
5,083 |
22,505 |
16,062 |
||||||
Total operating expenses |
20,240 |
14,585 |
72,940 |
59,056 |
||||||
Loss from operations |
(19,860) |
(14,205) |
(71,423) |
(57,539) |
||||||
Other income (expense), net |
(563) |
205 |
(1,735) |
1,492 |
||||||
Net loss |
$ (20,423) |
$ (14,000) |
$ (73,158) |
$ (56,047) |
||||||
Net loss attributable to common stockholders |
$ (20,423) |
$ (14,000) |
$ (77,064) |
$ (56,047) |
||||||
Net loss per share attributable to common |
||||||||||
stockholders--basic and diluted |
$ (0.44) |
$ (0.44) |
$ (1.87) |
$ (1.84) |
||||||
Weighted-average number of common stock |
||||||||||
used to compute net loss per share attributable |
||||||||||
to common stockholders--basic and diluted |
46,054,850 |
31,640,484 |
41,308,242 |
30,490,783 |
||||||
Merry Christmas and Happy New Year!
28 December 2024
NovaMedica team in the TOP 100 INFLUENTIAL PEOPLE IN THE PHARMACEUTICAL BUSINESS 2024
28 November 2024
05 November 2024
Merry Christmas and Happy New Year!
28 December 2024
Personal Data in European Medicine Regulation
28 December 2024
Belarus Republic creates production of oncology drugs for 1.5 billion rubles
27 December 2024
Tyumen Medical University has developed a lancet for diagnosing five socially significant diseases
27 December 2024