Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/1395937/000156459018026892/sndx-10q_20180930.htm
March 2024
February 2024
December 2023
December 2023
December 2023
November 2023
October 2023
August 2023
July 2023
May 2023
Exhibit 99.1
Syndax Pharmaceuticals Reports Third Quarter 2018 Financial Results and
Provides Clinical and Business Update
– Next assessment of primary endpoint of overall survival in E2112 trial expected in the second quarter of 2019 –
– Topline data across ENCORE I/O combinations and IND for Menin-MLLr inhibitor expected during the 1H19 –
– Company to host conference call today at 4:30 p.m. ET –
WALTHAM, Mass., November 5, 2018 (PRNEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the third quarter ended September 30, 2018. In addition, the Company provided a clinical and business update. As of September 30, 2018, Syndax had $89.6 million in cash, cash equivalents and short-term investments.
“The last several months have been marked by exciting progress across multiple programs, culminating with our recent announcement of plans to commence what will become our second registration study: a focused, biomarker-driven registration trial to evaluate entinostat in combination with pembrolizumab in patients with non-small cell lung cancer whose disease has progressed after PD-1 therapy,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “We remain highly encouraged by the potential for a positive overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which would allow us to file for full regulatory approval in this indication. We look forward to reporting on multiple exciting value inflection points across our ENCORE I/O combination trials in the coming months.”
Pipeline Updates
Entinostat
|
• |
At the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) in September, the Company presented data from the full cohort of PD-(L)1 refractory non-small cell lung cancer (NSCLC) patients enrolled in the ENCORE 601 trial of entinostat in combination with KEYTRUDA® (pembrolizumab). The data continued to support the prior observation of enhanced clinical benefit in a subpopulation of patients with elevated baseline levels of peripheral classical blood monocytes. In October, the Company announced plans to commence a focused, biomarker-driven, randomized registration trial comparing the entinostat-pembrolizumab combination to standard of care chemotherapy in patients whose disease has progressed after both platinum-based chemotherapy and PD-1 antagonist therapy. The trial will seek to validate peripheral classical monocytes as a marker of response to the combination and to determine whether the combination can improve progression free survival (PFS) over standard of care chemotherapy in the high monocyte population. The Company anticipates beginning the trial in the first half of 2019. |
|
• |
In October, Syndax announced that enrollment has concluded in E2112, the Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, with a total of 608 patients enrolled. ECOG-ACRIN Cancer Research Group and the National Cancer Institute informed the Company that the trial did not meet the statistical hurdle for the first primary endpoint of improving PFS, which would have provided the earliest regulatory filing opportunity. Following the most recent interim overall survival (OS) analysis conducted by the trial’s Data Safety Monitoring Committee, ECOG-ACRIN also informed Syndax that the trial is continuing as planned, with the next interim analysis for the OS primary endpoint scheduled for the second quarter of 2019. Additional interim analyses will be conducted every six months until either an OS benefit is observed, or the final target number of events occur. E2112 was designed, and obtained Breakthrough Therapy Designation for this indication, based on positive Phase 2b OS results. Any positive OS assessment would enable the Company to file for full regulatory approval. |
Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/1395937/000156459018026892/sndx-10q_20180930.htm
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Syndax Pharmaceuticals Inc.
Syndax Pharmaceuticals Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2018 10-K Annual Report includes:
Rating
Learn More
In the fourth quarter of 2018, up to November 2, 2018, we have sold an additional 784,587 shares of our common stock with net proceeds of approximately $6.1 million.
Research and Development For the nine months ended September 30, 2018, our total research and development expenses increased $12.7 million, or 40%, to $44.3 million from $31.6 million for the comparable period in the prior year due to increases in development expenses of $6.2 million, employee compensation expense of $3.9 million, professional fees of $2.4 million and facility costs of $0.3 million.
The increase in our net loss was primarily due to the increase in our clinical trial activities and CMC expenses.
21 In April 2017, we entered into a sales agreement with Cowen under which we may issue and sell shares of our common stock having aggregate sales proceeds of up to $50.0 million from time to time pursuant to the ATM Program.
The increase in legal fees is primarily due to an increase in patent related legal expenses.
The increase in legal fees...Read more
The increase was primarily due...Read more
The increase was primarily due...Read more
We will pay Cowen up...Read more
The increase in general and...Read more
Since our inception, our operations...Read more
The increase in general and...Read more
Research and development expenses consisted...Read more
General and Administrative For the...Read more
Net cash used in investing...Read more
Net cash provided by financing...Read more
We expect that our research...Read more
The amount of research and...Read more
The increase in development activities...Read more
Net Cash Provided by (Used...Read more
Research and development expenses consist...Read more
Costs for certain development activities,...Read more
If we raise additional funds...Read more
In May 2017, we completed...Read more
22 We have incurred losses...Read more
Clinical development timelines, the probability...Read more
Cowen is not required to...Read more
The increase in development expenses...Read more
Shares sold pursuant to the...Read more
Research and Development For the...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
Material Contracts, Statements, Certifications & more
Syndax Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits
Ticker: SNDX
CIK: 1395937
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-18-026892
Submitted to the SEC: Mon Nov 05 2018 12:01:45 PM EST
Accepted by the SEC: Mon Nov 05 2018
Period: Sunday, September 30, 2018
Industry: Pharmaceutical Preparations