– Updated positive data from Phase 1 portion of AUGMENT-101 trial demonstrates CR/CRh rate of 30% and a median durability of response of 9.1 months –
– Enrollment complete in pivotal Phase 2 AGAVE-201 trial of axatilimab in patients with cGVHD –
– Company remains on track for two U.S. registrational filings by the end of 2023 –
– Company to host conference call today at 4:30 p.m. ET –
WALTHAM, Mass., Nov. 3, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results and provided a business update for the third quarter ended September 30, 2022.
"As we near the end of this transformational year, we are particularly excited to share that updated data from the Phase 1 portion of the ongoing AUGMENT-101 trial of revumenib will be featured during two oral presentations at the American Society of Hematology (ASH) Annual Meeting in December. The rate of patients achieving a complete response (CR/CRh) and the nine-month median duration of CR/CRh response as of the data cutoff, further support the robust clinical profile of revumenib," said Michael A. Metzger, Chief Executive Officer. "The data continue to underscore the potential for revumenib to serve as a first- and best-in-class treatment option for patients with relapsed/refractory (R/R) nucleophosmin 1 (NPM1) mutations and mixed lineage leukemia rearrangements (MLLr). Enrollment continues in AUGMENT-101 and we anticipate reporting topline data from at least one of the pivotal cohorts starting in the third quarter of 2023, with a potential New Drug Application (NDA) filing expected by the end of 2023."
Mr. Metzger added, "We also continue to make significant progress on the development of axatilimab and are pleased to announce that we have completed enrollment in our pivotal AGAVE-201 trial in chronic graft versus host disease (cGVHD). We look forward to announcing topline results from the trial in mid-2023, with a potential biologics license application (BLA) filing expected to follow by the end of 2023."
Recent Pipeline Progress and Anticipated Milestones
Revumenib
Axatilimab
Third Quarter 2022 Financial Results
As of September 30, 2022, Syndax had cash, cash equivalents and short-term investments of $337.8 million and 61.3 million common shares and pre-funded warrants outstanding.
Third quarter 2022 research and development expenses increased to $26.9 million from $25.6 million for the prior year period. The increase was primarily due to increased employee related expenses and professional fees partially offset by decreased clinical and manufacturing expenses, in large part the result of axatilimab cost sharing benefits.
General and administrative expenses for the third quarter 2022 increased to $8.2 million from $6.8 million for the prior year period. The increase is primarily due to increased employee related expenses and professional fees.
For the three months ended September 30, 2022, Syndax reported a net loss attributable to common stockholders of $35.4 million, or $0.58 per share, compared to a net loss attributable to common stockholders of $20.6 million, or $0.40 per share, for the prior year period.
Financial Update and Guidance
For the full year of 2022, the Company is lowering its expectations of both research and development and total operating expenses. The Company now expects research and development expenses to be $115 to $125 million and total operating expenses to be $145 to $155 million. This is a reduction from the Company's prior guidance for the full year of 2022 of $130 to $140 million in research and development expenses and $160 to $170 million in total operating expenses. The updated guidance reflects the benefits derived from the shared expenses for our axatilimab cGVHD development program.
In September, Syndax made a debt repayment in connection with the termination of a Loan Agreement. This loan repayment has no adverse impact on Syndax's cash guidance and the Company continues to expect to have sufficient capital to fund operations into the second half of 2024.
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 3, 2022.
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: SYNDAXQ3
Domestic Dial-in Number: 800-225-9448
International Dial-in Number: 203-518-9708
Live webcast: https://www.veracast.com/webcasts/OpenEx/General/S03S7x.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 Pharmaceuticals, Inc.
Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib (SNDX-5613), a highly selective inhibitor of the Menin–MLL binding interaction, and axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, both currently in pivotal trials. 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," "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 use of our product candidates to treat various cancer indications and fibrotic diseases, and Syndax's expected fourth 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 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.
Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827
SNDX-G
SYNDAX PHARMACEUTICALS, INC. | |||||
(unaudited) | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
September 30, | December 31, | ||||
(In thousands) | 2022 | 2021 | |||
Cash, cash equivalents, short and long-term investments | $ 337,838 | $ 439,936 | |||
Total assets | $ 359,687 | $ 449,657 | |||
Total liabilities | $ 21,585 | $ 41,289 | |||
Total stockholders' equity (deficit) | $ 338,102 | $ 408,368 | |||
Common stock outstanding | 60,122,661 | 54,983,105 | |||
Common stock and common stock equivalents* | 68,877,618 | 66,011,976 | |||
*Common stock and common stock equivalents: | |||||
Common stock | 60,122,661 | 54,983,105 | |||
Common stock warrants (pre-funded) | 1,142,856 | 3,975,024 | |||
Common stock and pre-funded stock warrants | 61,265,517 | 58,958,129 | |||
Options to purchase common stock | 7,386,063 | 6,921,514 | |||
Restricted Stock Units | 226,038 | 132,333 | |||
Total common stock and common stock equivalents | 68,877,618 | 66,011,976 |
SYNDAX PHARMACEUTICALS, INC. | |||||||||
(unaudited) | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||
(In thousands, except share and per share data) | 2022 | 2021 | 2022 | 2021 | |||||
License fee revenue | $ - | $ 12,375 | $ - | $ 13,133 | |||||
Operating expenses: | |||||||||
Research and development | 26,901 | 25,606 | 86,658 | 64,348 | |||||
General and administrative | 8,240 | 6,801 | 23,066 | 18,314 | |||||
Total operating expenses | 35,141 | 32,407 | 109,724 | 82,662 | |||||
Loss from operations | (35,141) | (20,032) | (109,724) | (69,529) | |||||
Other (expense) income, net | (262) | (607) | (420) | (1,743) | |||||
Net loss | $ (35,403) | $ (20,639) | $ (110,144) | $ (71,272) | |||||
Net loss attributable to common stockholders | $ (35,403) | $ (20,639) | $ (110,144) | $ (71,272) | |||||
Net loss per share attributable to common | |||||||||
stockholders--basic and diluted | $ (0.58) | $ (0.40) | $ (1.84) | $ (1.38) | |||||
Weighted-average number of common stock | |||||||||
used to compute net loss per share attributable | |||||||||
to common stockholders--basic and diluted | 60,670,294 | 51,962,320 | 59,941,384 | 51,690,173 |
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SOURCE Syndax Pharmaceuticals, Inc.