Syndax(SNDX)

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Syndax(SNDX) - 2022 Q3 - Quarterly Report
2022-11-03 20:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 (781) 419-1400 (Registrant's Telephone Number, Including Area Code) or Securities registered pursuant to Section 12(b) of the Act: ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: ...
Syndax(SNDX) - 2022 Q2 - Earnings Call Transcript
2022-08-08 23:55
Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Briggs Morrison - President and Head, R&D Keith Goldan - Chief Financial Officer Anjali Ganguli - Chief Business Officer Conference Call Participants Phil Nadeau - Cowen & Company Kalpit Patel - B. Riley Securities Ashiq Mubarack - Citi Joel Beatty - Baird Peter Lawson - Barclays Operator Good day everyo ...
Syndax(SNDX) - 2022 Q2 - Earnings Call Presentation
2022-08-08 20:35
Determined to realize a future in which people with cancer live longer and better than ever before Syndax 參 2Q22 EARNINGS PRESENTATION – AUGUST 8, 2022 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify ...
Syndax(SNDX) - 2022 Q2 - Quarterly Report
2022-08-08 20:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37708 Syndax Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 32-0162505 (State or Other Ju ...
Syndax(SNDX) - 2022 Q1 - Earnings Call Transcript
2022-05-10 00:13
Financial Data and Key Metrics Changes - The net loss for Q1 2022 was $37.2 million or $0.63 per share, compared to a net loss of $27.7 million or $0.54 per share for the same period last year, primarily due to increased clinical activities [52][55]. - The company ended Q1 2022 with $397.9 million in cash and cash equivalents, with a cash runway extending into the second half of 2024 [53]. Business Line Data and Key Metrics Changes - Enrollment in pivotal Phase 2 trials for Revumenib (SNDX-5613) is on track, with three trials ongoing for different indications in acute leukemia [10][14]. - Axatilimab is currently in the pivotal AGAVE-201 trial for chronic graft versus host disease (cGVHD), with top-line data expected in 2023 [11][40]. Market Data and Key Metrics Changes - The company anticipates being the first to achieve regulatory approval for a menin inhibitor, which is expected to enhance long-term value [15]. - The potential market opportunity for Revumenib in treating NPM1 and MLLR mutant acute leukemias is significant, addressing up to 12,500 patients annually [26]. Company Strategy and Development Direction - The company aims to expand its lead assets into new indications and build a commercial organization to support potential product launches [8][12]. - There is a focus on pursuing business development opportunities to augment the pipeline with promising molecules [9]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's solid balance sheet and the support from a strong pharmaceutical partner to advance development [8]. - The company is optimistic about completing enrollment in at least one of the ongoing trials this year and expects to file for regulatory approval in 2023 [14][15]. Other Important Information - The company plans to hire its first Chief Commercial Officer to lead the build-out of its commercial organization later this year [12]. - The collaboration with Incyte aims to maximize the development of axatilimab and explore additional indications in fibrotic diseases [42]. Q&A Session Summary Question: Recruitment cadence for AUGMENT-101 trial - Management indicated that they have three independent trials enrolling and have not provided guidance on which will finish first, but they expect top-line data in the first half of 2023 [65][66]. Question: Statistical plan for AUGMENT-101 - The primary endpoint is the percentage of patients achieving CR/CRh, with no prespecified requirement for durability [69][80]. Question: Durability requirements for filing - There is no durability requirement for filing, but a median duration of response of at least four to six months has been acceptable in the past [79]. Question: Assessment of MRD negativity in INTERCEPT trial - MRD negativity for MLR patients is assessed using flow cytometry [86]. Question: Rationale for combinations with ASTX727 - The combination is being explored as it allows for an all-oral regimen, which is of interest to investigators [88]. Question: Benchmarks for BEAT-AML trial - The overall response rate for frontline Ven/Aza is in the mid-60s, with lower CR rates [92]. Question: Competitive landscape for menin inhibitors - The company believes it is in the lead for developing menin inhibitors and is focused on leveraging its first-mover advantage [98].
Syndax(SNDX) - 2022 Q1 - Earnings Call Presentation
2022-05-09 22:56
Determined to realize a future in which people with cancer live longer and better than ever before Syndax §> 1Q22 EARNINGS PRESENTATION Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking ...
Syndax(SNDX) - 2022 Q1 - Quarterly Report
2022-05-09 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37708 Syndax Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 32-0162505 (State or Other J ...
Syndax Pharmaceuticals (SNDX) Presents At Barclays Global Healthcare Conference
2022-03-23 18:21
Determined to realize a future in which people with cancer live longer and better than ever before Syndax 參 CORPORATE PRESENTATION | MARCH 2022 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward- ...
Syndax Pharmaceuticals (SNDX) Investor Presentation - Slideshow
2022-03-11 18:28
Determined to realize a future in which people with cancer live longer and better than ever before Syndax 參 CORPORATE PRESENTATION | MARCH 2022 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward- ...
Syndax(SNDX) - 2021 Q4 - Earnings Call Transcript
2022-03-02 03:37
Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2021 Earnings Conference Call March 1, 2022 4:30 PM ET Company Participants Maghan Meyers - Vice President, Argot Partners Michael Metzger - Chief Executive Officer Alexander Nolte - Chief Accounting Officer Anjali Ganguli - Chief Business Officer Briggs Morrison - President and Head of Research and Development Conference Call Participants Phil Nadeau - Cowen Inc. Robert Hazlett - BTIG, LLC Ashiq Mubarack - Citigroup Inc. Justin Walsh - B. Riley Securities, Inc. ...