UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 2, 2023, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
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Description
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99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SYNDAX PHARMACEUTICALS, INC. |
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By: |
/s/ Michael A. Metzger |
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Michael A. Metzger |
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Chief Executive Officer |
Dated: November 2, 2023
Exhibit 99.1
Syndax Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update
– NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia under RTOR –
– mNPM1 final efficacy data from the Phase 1 portion of AUGMENT-101 demonstrates a 36%
CR/CRh rate –
– Revumenib and axatilimab U.S. registrational filings on track for year-end 2023 completion and potential 2024 approvals –
– Axatilimab to be featured in plenary session at 65th ASH Annual Meeting –
– Revumenib pivotal monotherapy results, combination with venetoclax and post-transplant maintenance data to be highlighted at 65th ASH Annual Meeting –
– Company to host conference call today at 4:30 p.m. ET –
WALTHAM, Mass., November 2, 2023 (PRNEWSWIRE) – Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the quarter ended September 30, 2023, and provided a business update.
“Syndax continues to make excellent progress against our key milestones and corporate priorities and is well positioned to potentially launch two first- and best-in-class blockbuster therapies in 2024,” said Michael A. Metzger, Chief Executive Officer. “We are also pleased to announce final Phase 1 mNPM1 data with a 36% CR/CRh rate, which demonstrates revumenib’s ability as a monotherapy with excellent safety and tolerability to drive patients with mNPM1 AML to durable MRD negative remissions. We recently shared topline pivotal data for revumenib in R/R KMT2Ar acute leukemia, our second positive pivotal result over the past few months. We look forward to providing additional monotherapy and combination data, which further highlight the compelling clinical profile and utility of each asset, next month at the ASH Annual Meeting.”
New Data Announcement
The Company announced today positive data from the Phase 1 portion of the AUGMENT-101 trial of revumenib in a total of 14 patients with relapsed or refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) who met the recommended Phase 2 dose (RP2D) criteria. The final dataset includes three additional patients that were enrolled in the Phase 1 trial to complete the pharmacokinetic characterization of revumenib.In this analysis, the overall response rate (ORR)1 was 50% (7/14) with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 36% (5/14); 100% (5/5) of CR/CRh patients were minimal residual disease (MRD) negative. 43% (3/7) of responders proceeded to transplant, all after achieving a CR or CRh. 60% (3/5) of CR/CRh patients maintained a response beyond six months. At the time of the analysis, four patients remained in response, with two patients in response over twenty-two months. Revumenib was well tolerated, and the safety profile was consistent with what was previously reported in the AUGMENT-101 trial. There were no Grade 4 or 5 QTc prolongation or greater than Grade 2 differentiation syndrome events, and no patients discontinued due to treatment-related adverse events (TREAs).
Recent Pipeline Progress and Anticipated Milestones
Revumenib
The AUGMENT-101 pivotal data will be presented at the upcoming 65th American Society of Hematology (ASH) Annual Meeting on Sunday, December 10, 2023. Of note, the abstract for this session only includes data from the Phase 1 portion of the AUGMENT-101 trial, however the presentation will describe the pivotal dataset.
Axatilimab
The pivotal AGAVE-201 trial results will be featured at the plenary session at the ASH Annual Meeting on Sunday, December 10, 2023. A copy of the abstract is available on the ASH website at www.hematology.org.
Third Quarter 2023 Financial Results
As of September 30, 2023, Syndax had cash, cash equivalents, short and long-term investments of $379.3 million and 69.9 million common shares and prefunded warrants outstanding.
Third quarter 2023 research and development expenses increased to $39.1 million from $26.9 million for the comparable prior year period. The increase in research and development expenses was primarily due to increased employee-related expenses and professional fees as well as increased clinical and manufacturing expenses.
Third quarter 2023 general and administrative expenses increased to $17.3 million from $8.2 million for the comparable prior year period. The increase is primarily due to employee-related expenses and professional fees.
For the three months ended September 30, 2023, Syndax reported a net loss attributable to common stockholders of $51.1 million, or $0.73 per share, compared to a net loss attributable to common stockholders of $35.4 million, or $0.58 per share, for the comparable prior year period.
Financial Update and Guidance
For the full year of 2023, the Company expects research and development expenses to be $160 to $165 million and total operating expenses to be $225 to $230 million. This is a reduction from prior guidance of $160 to $175 million for research and development expenses and $225 to $240 million for total operating expenses.
Conference Call and Webcast
In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, November 2, 2023.
The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alternatively, the conference call may be accessed through the following:
Conference ID: SNDX3Q23
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: https://www.veracast.com/webcasts/syndax/events/SNDX3Q23.cfm
For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.
About Syndax
Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a highly selective inhibitor of the Menin–KMT2A binding interaction, and axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.
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,” “could,” “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, the reporting of clinical data for Syndax’s product candidates, the potential submission of an NDA and BLA by year-end, the potential use of our product candidates to treat various cancer indications and fibrotic diseases, and Syndax’s expected full year research and development expenses as well as full year 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; 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.
References
1 Overall response rate includes CR, CRh, CRp, CRi, MLFS, and PR
CR = Complete remission
CRh = Complete remission with partial hematologic recovery
CRp = Complete remission with incomplete platelet recovery
CRi = Complete remission with incomplete count recovery
MLFS = Morphologic leukemia-free state
PR = Partial response
Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827
SNDX-G
SYNDAX PHARMACEUTICALS, INC. |
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(unaudited) |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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September 30, |
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December 31, |
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(In thousands) |
2023 |
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2022 |
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Cash, cash equivalents, short and long-term investments |
$ |
379,261 |
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$ |
481,271 |
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Total assets |
$ |
399,224 |
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$ |
497,236 |
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Total liabilities |
$ |
40,038 |
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$ |
29,787 |
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Total stockholders' equity |
$ |
359,186 |
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$ |
467,449 |
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Common stock outstanding |
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69,638,168 |
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68,111,385 |
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Common stock and common stock equivalents* |
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83,992,083 |
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77,460,706 |
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*Common stock and common stock equivalents: |
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Common stock |
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69,638,168 |
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68,111,385 |
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Common stock warrants (pre-funded) |
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285,714 |
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1,142,856 |
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Common stock and pre-funded stock warrants |
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69,923,882 |
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69,254,241 |
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Options to purchase common stock |
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13,543,965 |
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7,981,677 |
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Restricted Stock Units |
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524,236 |
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224,788 |
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Total common stock and common stock equivalents |
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83,992,083 |
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77,460,706 |
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SYNDAX PHARMACEUTICALS, INC. |
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(unaudited) |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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(In thousands, except share and per share data) |
2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
$ |
39,087 |
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$ |
26,901 |
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$ |
107,906 |
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$ |
86,658 |
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General and administrative |
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17,268 |
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8,240 |
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44,143 |
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23,066 |
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Total operating expenses |
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56,355 |
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35,141 |
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152,049 |
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109,724 |
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Loss from operations |
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(56,355 |
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(35,141 |
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(152,049 |
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(109,724 |
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Other income (expense), net |
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5,209 |
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(262 |
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15,162 |
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(420 |
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Net loss |
$ |
(51,146 |
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$ |
(35,403 |
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$ |
(136,887 |
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$ |
(110,144 |
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Net loss attributable to common stockholders |
$ |
(51,146 |
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$ |
(35,403 |
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$ |
(136,887 |
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$ |
(110,144 |
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Net loss per share attributable to common |
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stockholders--basic and diluted |
$ |
(0.73 |
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$ |
(0.58 |
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$ |
(1.97 |
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$ |
(1.84 |
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Weighted-average number of common stock |
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used to compute net loss per share attributable |
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to common stockholders--basic and diluted |
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69,855,766 |
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60,670,294 |
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69,645,888 |
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59,941,384 |
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