Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update
Syndax Pharmaceuticals (SNDX) reported Q3 2024 financial results with a net loss of $84.1 million ($0.98 per share). The company secured FDA approval for Niktimvo for chronic GVHD treatment and expects its launch by early Q1 2025. A $350 million royalty funding agreement with Royalty Pharma was announced. The company's revumenib NDA for R/R KMT2Ar acute leukemia has a PDUFA date of December 26, 2024. Cash position stands at $399.6 million, with R&D expenses increasing to $71.0 million and SG&A expenses rising to $31.1 million. Full-year 2024 operating expenses are projected at $365-370 million.
Syndax Pharmaceuticals (SNDX) ha riportato i risultati finanziari del terzo trimestre del 2024, con una perdita netta di 84,1 milioni di dollari (0,98 dollari per azione). L'azienda ha ottenuto l'approvazione della FDA per Niktimvo per il trattamento della GVHD cronica e prevede di lanziare il prodotto all'inizio del primo trimestre del 2025. È stato annunciato un accordo di finanziamento con royalty di 350 milioni di dollari con Royalty Pharma. La NDA di revumenib per la leucemia acuta KMT2Ar recidivante/resistente ha una data PDUFA fissata per il 26 dicembre 2024. La posizione di liquidità si attesta a 399,6 milioni di dollari, con le spese per ricerca e sviluppo aumentate a 71,0 milioni di dollari e le spese per vendite, generali e amministrative salite a 31,1 milioni di dollari. Le spese operative per l'intero anno del 2024 sono stimate tra 365 e 370 milioni di dollari.
Syndax Pharmaceuticals (SNDX) reportó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 84,1 millones de dólares (0,98 dólares por acción). La compañía recibió la aprobación de la FDA para Niktimvo para el tratamiento de la GVHD crónica y espera lanzarlo a principios del primer trimestre de 2025. Se anunció un acuerdo de financiación por regalías de 350 millones de dólares con Royalty Pharma. La NDA de revumenib para leucemia aguda KMT2Ar en recaída/resistente tiene una fecha PDUFA del 26 de diciembre de 2024. La posición de efectivo se sitúa en 399,6 millones de dólares, con gastos de I+D que aumentan a 71,0 millones de dólares y gastos de SG&A que ascienden a 31,1 millones de dólares. Se proyecta que los gastos operativos para todo el año 2024 oscilarán entre 365 y 370 millones de dólares.
신닥스 제약 (SNDX)이 2024년 3분기 재무 결과를 발표했으며, 순손실은 8410만 달러(주당 0.98달러)로 나타났습니다. 이 회사는 만성 GVHD 치료를 위한 닉팀보에 대해 FDA 승인을 받았으며 2025년 1분기 초에 출시할 것으로 기대하고 있습니다. 로열티 제약사와 3억 5000만 달러의 로열티 자금 조달 계약이 발표되었습니다. 레부미닙의 NDA는 재발/저항성 KMT2Ar 급성 백혈병에 대한 것으로, PDUFA 날짜는 2024년 12월 26일입니다. 현금 보유액은 3억 9960만 달러이며, 연구개발 비용은 7100만 달러로 증가하고, 판매관리비(SG&A) 비용은 3110만 달러로 상승했습니다. 2024년 전체 연간 운영 비용은 3억 6500만에서 3억 7000만 달러로 예상됩니다.
Syndax Pharmaceuticals (SNDX) a rapporté les résultats financiers du troisième trimestre 2024, avec une perte nette de 84,1 millions de dollars (0,98 dollars par action). L'entreprise a obtenu l'approbation de la FDA pour Niktimvo pour le traitement de la GVHD chronique et prévoit son lancement au début du premier trimestre 2025. Un accord de financement de redevances de 350 millions de dollars avec Royalty Pharma a été annoncé. La NDA de revumenib pour la leucémie aiguë KMT2Ar en rechute/résistante a une date PDUFA fixée au 26 décembre 2024. La position de liquidités s'élève à 399,6 millions de dollars, avec des dépenses de R&D ayant augmenté à 71,0 millions de dollars et des dépenses SG&A atteignant 31,1 millions de dollars. Les dépenses d'exploitation pour l'année complète 2024 sont estimées entre 365 et 370 millions de dollars.
Syndax Pharmaceuticals (SNDX) hat die Finanzzahlen für das dritte Quartal 2024 mit einem Nettoverlust von 84,1 Millionen US-Dollar (0,98 US-Dollar pro Aktie) veröffentlicht. Das Unternehmen sicherte sich die FDA-Zulassung für Niktimvo zur Behandlung von chronischer GVHD und plant die Markteinführung Anfang des ersten Quartals 2025. Es wurde ein Lizenzgebühren-Finanzierungsvertrag über 350 Millionen US-Dollar mit Royalty Pharma bekannt gegeben. Der NDA-Antrag für revumenib zur Behandlung von Rezidiv/Resistenz KMT2Ar akuter Leukämie hat ein PDUFA-Datum vom 26. Dezember 2024. Die Liquiditätsposition liegt bei 399,6 Millionen US-Dollar, während die F&E-Ausgaben auf 71,0 Millionen US-Dollar und die SG&A-Ausgaben auf 31,1 Millionen US-Dollar gestiegen sind. Für das gesamte Jahr 2024 werden die Betriebskosten auf 365 bis 370 Millionen US-Dollar geschätzt.
- FDA approval received for Niktimvo in chronic GVHD treatment
- Secured $350 million royalty funding agreement with Royalty Pharma
- Strong cash position of $399.6 million
- Company expects to reach profitability with current funding
- Net loss increased to $84.1 million from $51.1 million YoY
- R&D expenses increased 82% to $71.0 million YoY
- SG&A expenses rose 80% to $31.1 million YoY
Insights
The Q3 2024 results reveal significant developments for Syndax Pharmaceuticals. Key financial metrics show
The FDA approval of Niktimvo and potential December 2024 approval of revumenib represent major catalysts. R&D expenses increased
The net loss widened to
The clinical development pipeline shows robust progress across multiple programs. Revumenib's pivotal AUGMENT-101 trial demonstrates durable responses with median CR/CRh duration extending to 13 months. The BEAT AML trial's
Niktimvo's approval for chronic GVHD represents a significant advancement, supported by strong clinical data published in the New England Journal of Medicine. The expansion into idiopathic pulmonary fibrosis through the MAXPIRe trial could open additional market opportunities.
The multiple ongoing combination trials and planned pivotal studies suggest a comprehensive development strategy aimed at expanding indications and treatment settings, potentially leading to broader market adoption.
– New revumenib and Niktimvo™ clinical data will be highlighted at 66th ASH Annual Meeting –
– mNPM1 AML topline data from AUGMENT-101 expected in 4Q24; potential sNDA filing in 1H25 –
– Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 –
– Niktimvo approved by
–
– Company to host a conference call today at 4:30 p.m. ET –
"This has been a historic period for Syndax as we transitioned to a commercial-stage company with the approval of Niktimvo. With the recently completed royalty financing, we expect to be funded through profitability and we are well positioned to maximize the potential of our pipeline," said Michael A. Metzger, Chief Executive Officer. "We have a very exciting quarter ahead with the anticipated FDA approval and
Recent Pipeline Progress and Anticipated Milestones
Revumenib
- The New Drug Application (NDA) for revumenib, an oral menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia was granted Priority Review and is being reviewed under the
U.S. FDA's Real-Time Oncology Review (RTOR) Program with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2024. - The Company expects to report topline data from the AUGMENT-101 pivotal trial cohort of patients with R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) in the fourth quarter of 2024. Positive data could support a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025.
- The Company announced that data from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib in adult and pediatric patients with R/R KMT2Ar AML and acute lymphoid leukemia (ALL) have been published in the Journal of Clinical Oncology.
- The Company announced that a larger data set and longer follow-up from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib in R/R KMT2Ar acute leukemia will be presented at the upcoming 66th American Society of Hematology (ASH) Annual Meeting. The larger efficacy population (n=97) includes the 57 patients from the previously reported interim efficacy analysis plus an additional 40 patients. Consistent with previously reported data, the updated analysis shows that revumenib provides durable responses and robust rates of overall response, minimal residual disease (MRD) negativity, and hematopoietic stem cell transplantation (HSTC). With seven months of additional follow-up, the median duration of CR/CRh extended to 13 months among the 13 CR/CRh responders included in the interim analysis presented at ASH 2023.
- Multiple trials evaluating the potential to expand revumenib use across the mNPM1 and KMT2Ar acute leukemia treatment landscape are ongoing. These trials include:
- BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in front-line AML patients. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial. The Company presented updated positive data from the trial at the European Hematology Association (EHA) 2024 Congress, showing a
96% (23 of 24 pts) composite complete remission (CRc) rate in patients with newly diagnosed mNPM1 or KMT2Ar AML. The BEAT AML trial is expanding to validate the recommended Phase 2 dose of the combination of revumenib with venetoclax and azacitidine. The company anticipates that an update on the trial will be available in the fourth quarter of 2024. - SAVE: A Phase 1 trial evaluating the all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in R/R AML or mixed phenotype acute leukemias. The trial is being conducted by investigators from MD Anderson Cancer Center. The Company announced that updated data showing an
88% ORR (23 of 26 pts) in R/R patients with KMT2Ar, mNPM1, or NUP98r leukemias will be presented at the upcoming 66th ASH Annual Meeting. In addition to the R/R cohort, a frontline cohort is now enrolling patients. - INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial. Preliminary results from the first eight mNPM1 patients treated with revumenib will be presented at the upcoming 66th ASH Annual Meeting.
- Intensive chemotherapy: A Phase 1 trial evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias. The trial is designed to identify the recommended Phase 2 dose for this combination to support further development.
- Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading
U.S. cancer research centers.
- BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in front-line AML patients. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial. The Company presented updated positive data from the trial at the European Hematology Association (EHA) 2024 Congress, showing a
- The Company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients unfit to receive intensive chemotherapy by year-end 2024.
- The Company is evaluating revumenib in patients with R/R metastatic microsatellite stable (MSS) colorectal cancer (CRC). The trial is currently enrolling patients in the Phase 1b portion of its Phase 1/2 proof-of-concept trial.
Niktimvo™ (axatilimab-csfr)
- Niktimvo received U.S. Food and Drug Administration (FDA) approval for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). The Company anticipates that Niktimvo will be launched in the
U.S. no later than early first quarter 2025. In theU.S. , Niktimvo will be co-commercialized by Syndax and Incyte. - The Company announced Niktimvo was added to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A recommendation for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Treatments are classified as category 2A when there is uniform NCCN consensus that the intervention is appropriate, based on lower level evidence.
- The Company announced that results from the pivotal Phase 2 AGAVE-201 trial of Niktimvo in adult and pediatric patients with recurrent/refractory active chronic GVHD who had received at least two prior lines of systemic therapy were published in the New England Journal of Medicine.
- The Company announced a secondary analysis of overall and organ-specific responses from the pivotal Phase 2 AGAVE-201 trial of Niktimvo in adult and pediatric patients with recurrent/refractory active chronic GVHD who had received at least two prior lines of systemic therapy will be presented at the 66th ASH Annual Meeting. The data demonstrated rapid responses and symptom improvement in inflammatory and fibrotic manifestations of chronic GVHD in heavily pretreated patients.
- Enrollment is ongoing in a 26-week randomized, double-blinded, placebo-controlled Phase 2 trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF), now referred to as the MAXPIRe trial (NCT06132256). The Company expects to report topline data from the trial in 2026.
- The Company's partner, Incyte, is now recruiting patients for a Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥12 years of age with newly diagnosed chronic GVHD (NCT06388564). A Phase 3 trial of axatilimab in combination with steroids for the treatment of chronic GVHD is currently in preparation.
Corporate Update
The Company announced a
Third Quarter 2024 Financial Results
As of September 30, 2024, Syndax had cash, cash equivalents, and short- and long-term investments of
Third quarter 2024 research and development expenses increased to
Third quarter 2024 selling, general and administrative expenses increased to
For the three months ended September 30, 2024, Syndax reported a net loss attributable to common stockholders of
Financial Guidance
For the full year of 2024, the Company expects research and development expenses to be
Syndax expects that its cash, cash equivalents and marketable securities, together with the
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, Tuesday, November 5, 2024.
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: Syndax3Q24
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: https://www.veracast.com/webcasts/syndax/events/SNDX3Q24.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 Revumenib
Revumenib is an oral, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed for the treatment of KMT2A-rearranged (KMT2Ar), also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including acute lymphoid leukemia (ALL) and acute myeloid leukemia (AML), and mNPM1 AML. The Journal of Clinical Oncology published results from the Phase 2 AUGMENT-101 trial of revumenib in R/R KMT2Ar acute leukemia showing the trial met its primary endpoint.
Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the
About Niktimvo™ (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for use in the
In the
In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.
Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) is underway and a Phase 3 combination trial with steroids is in preparation. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).
About the Real-Time Oncology Review Program (RTOR)
RTOR provides a more efficient review process for oncology drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. Specifically, it allows for close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review. Additional information about RTOR can be found at: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
About Syndax
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly 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 "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, 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 its product candidates to treat various cancer indications and fibrotic diseases, Syndax's expected full year research and development expenses, expected full year total operating expenses, and Syndax's expectations for liquidity and future operations. 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
Niktimvo is a trademark of Incyte.
All other trademarks are the property of their respective owners.
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) | 2024 | 2023 | |||||||
Cash, cash equivalents, short and long-term investments | $ | 399,636 | $ | 600,527 | |||||
Total assets | $ | 425,811 | $ | 612,880 | |||||
Total liabilities | $ | 59,379 | $ | 58,684 | |||||
Total stockholders' equity | $ | 366,432 | $ | 554,196 | |||||
Common stock outstanding | 85,285,488 | 84,826,632 | |||||||
Common stock and common stock equivalents* | 99,238,167 | 96,316,640 | |||||||
*Common stock and common stock equivalents: | |||||||||
Common stock | 85,285,488 | 84,826,632 | |||||||
Common stock warrants (pre-funded) | 285,714 | 285,714 | |||||||
Common stock and pre-funded stock warrants | 85,571,202 | 85,112,346 | |||||||
Options to purchase common stock | 12,205,960 | 10,684,858 | |||||||
Restricted Stock Units | 1,461,005 | 519,436 | |||||||
Total common stock and common stock equivalents | 99,238,167 | 96,316,640 |
SYNDAX PHARMACEUTICALS, INC. | |||||||||||||||||
(unaudited) | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
(In thousands, except share and per share data) | 2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenue | |||||||||||||||||
Milestone and license revenue | $ | 12,500 | $ | - | $ | 16,000 | $ | - | |||||||||
Total revenue | 12,500 | - | 16,000 | - | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 70,971 | $ | 39,087 | $ | 176,118 | $ | 107,906 | |||||||||
Selling, general and administrative | 31,106 | 17,268 | 83,189 | 44,143 | |||||||||||||
Total operating expenses | 102,077 | 56,355 | 259,307 | 152,049 | |||||||||||||
Loss from operations | (89,577) | (56,355) | (243,307) | (152,049) | |||||||||||||
Other income (expense), net | 5,451 | 5,209 | 18,718 | 15,162 | |||||||||||||
Net loss | $ | (84,126) | $ | (51,146) | $ | (224,589) | $ | (136,887) | |||||||||
Net loss attributable to common stockholders | $ | (84,126) | $ | (51,146) | $ | (224,589) | $ | (136,887) | |||||||||
Net loss per share attributable to common | $ | (84,126) | $ | (51,146) | $ | (224,589) | $ | (136,887) | |||||||||
stockholders--basic and diluted | $ | (0.98) | $ | (0.73) | $ | (2.63) | $ | (1.97) | |||||||||
Weighted-average number of common stock | |||||||||||||||||
used to compute net loss per share attributable | |||||||||||||||||
to common stockholders--basic and diluted | 85,433,569 | 69,855,766 | 85,307,660 | 69,645,888 |
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SOURCE Syndax Pharmaceuticals, Inc.
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