Financial Data and Key Metrics Changes - The company reported operating expenses of $102.1 million for Q3 2024, which included $71 million in research and development and $31.1 million in selling, general, and administrative expenses [55] - The company narrowed its full-year 2024 guidance, expecting research and development expenses to be between $245 million and $250 million, and total expenses to be between $365 million and $370 million [55] Business Line Data and Key Metrics Changes - The FDA approved Niktimvo for chronic graft-versus-host disease (GVHD), marking a significant milestone for the company [9] - Revumenib is anticipated to receive FDA approval for relapsed or refractory KMT2A rearranged acute leukemia by December 26, 2024, with compelling clinical data supporting its use [13][14] Market Data and Key Metrics Changes - The total addressable market for third-line or later chronic GVHD treatment in the US is estimated to be between $1.5 billion and $2 billion [43] - The combined accessible population for KMT2A and NPM1 acute leukemias in the relapsed or refractory setting is estimated to be between 5,000 and 6,500 patients, with a market opportunity approaching $2 billion in the US [50] Company Strategy and Development Direction - The company aims to leverage the recent $350 million royalty agreement for Niktimvo to strengthen its balance sheet and fund the commercialization of both Niktimvo and revumenib [8][52] - The company is focused on establishing a first-mover advantage in the menin inhibitor space, with plans for a pivotal Phase 3 trial in combination with venetoclax and azacitidine for newly diagnosed patients [34][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launches of Niktimvo and revumenib, highlighting the strong commercial opportunities and the need for new treatment options in the market [41][49] - The management team emphasized the importance of rapid data publication and guideline inclusion following drug approvals to maximize market penetration [61][68] Other Important Information - The company has a robust clinical development program for revumenib, with multiple ongoing trials and promising data supporting its use in various settings [19][31] - The company has established partnerships, such as with Incyte, to enhance its commercial efforts and leverage existing relationships in the chronic GVHD community [41][43] Q&A Session Summary Question: What is the process for getting into guidelines post-approval? - Management explained that after drug approval, data must be published, and then submitted for inclusion in guidelines, with a quick turnaround expected based on past experiences [60] Question: What is the expected maintenance percentage for revumenib in the commercial setting? - Management indicated that the maintenance percentage observed in trials may continue in the commercial setting, with expectations for more patients to be treated post-transplant [64] Question: Does the royalty agreement accelerate any development programs? - Management confirmed that the royalty agreement strengthens the balance sheet and allows for aggressive advancement of planned trials and programs [67] Question: What is the expected clinical bar for CR/CRh rate for pivotal NPM1 data? - Management stated that a CR/CRh rate of 20% to 30% is considered approvable, with confidence in achieving results within that range based on previous data [81] Question: Is the updated KMT2A data the most recent analysis submitted to the FDA? - Management clarified that while they cannot confirm specifics about the FDA review, the updated data is consistent and supportive of approval [88]

| --- | --- | --- | --- | |-------------------------------------|-------|-------|-----------------------------------------------------------------| | | | | | | | | | | | Syndax Reimagining Cancer Treatment | | | | | | | | Third Quarter Financial Results Presentation / November 5, 2024 | 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," "anticipa ...

Syndax Pharmaceuticals (SNDX) came out with a quarterly loss of $0.98 per share versus the Zacks Consensus Estimate of a loss of $1.13. This compares to loss of $0.73 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 13.27%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.91 per share when it actually produced a loss of $0.80, delivering a surprise of 12.09%.Over the last four quarters, ...

Financial Performance - Syndax reported a net loss of $84.1 million, or $0.98 per share, for Q3 2024, compared to a net loss of $51.1 million, or $0.73 per share, in the same period last year[14]. - Total operating expenses for the three months ended September 30, 2024, were $102.1 million, up from $56.4 million in the same period last year, representing an increase of 81.2%[25]. - The net loss for the three months ended September 30, 2024, was $84.1 million, compared to a net loss of $51.1 million for the same period in 2023, reflecting a year-over-year increase of 64.5%[25]. - Research and development expenses for the three months ended September 30, 2024, were $71.0 million, a 81.6% increase from $39.1 million in the same period last year[25]. Expenses - Research and development expenses increased to $71.0 million in Q3 2024 from $39.1 million in the prior year, primarily due to higher clinical development and pre-commercial manufacturing costs[12]. - Selling, general and administrative expenses rose to $31.1 million in Q3 2024, up from $17.3 million in the prior year, driven by increased commercial readiness activities for revumenib and axatilimab[13]. - The company expects full-year 2024 research and development expenses to be between $245 million and $250 million, and total operating expenses to be between $365 million and $370 million[15]. Cash and Assets - As of September 30, 2024, Syndax had cash, cash equivalents, and investments totaling $399.6 million[11]. - Syndax's total assets decreased from $612.9 million on December 31, 2023, to $425.8 million on September 30, 2024, a decline of 30.5%[24]. - Total stockholders' equity decreased from $554.2 million on December 31, 2023, to $366.4 million on September 30, 2024, a decrease of 33.8%[24]. Product Development and Approvals - Revumenib's New Drug Application (NDA) is under Priority Review with a PDUFA action date set for December 26, 2024[3]. - Topline data from the AUGMENT-101 trial for R/R mNPM1 AML is expected in Q4 2024, with a potential supplemental NDA filing in the first half of 2025[4]. - Niktimvo received FDA approval for chronic GVHD treatment and is anticipated to launch in the U.S. by early Q1 2025[9]. - Niktimvo (axatilimab-csfr) is approved in the U.S. for chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies[20]. - The company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine by year-end 2024[8]. - The company has ongoing clinical trials for axatilimab, including a Phase 2 trial in chronic GVHD and a Phase 2 trial in idiopathic pulmonary fibrosis[20]. Revenue - Syndax reported milestone and license revenue of $12.5 million for the three months ended September 30, 2024, compared to $0 for the same period in 2023[25]. Stock Information - Syndax's common stock outstanding increased from 84,826,632 shares to 85,285,488 shares from December 31, 2023, to September 30, 2024[24]. - The weighted-average number of common stock used to compute net loss per share increased from 69,645,888 to 85,433,569 shares year-over-year[25].

–  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 U.S. FDA for treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg ––  $350 million royalty funding ...

Proceeds expected to support the upcoming planned launches and fund the continued development of Niktimvo and revumenibExpected to fund Company through profitability; proforma cash approaching $800 million as of June 30WALTHAM, Mass. and NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) and Royalty Pharma plc (Nasdaq: RPRX) today announced that Syndax has entered into a $350 million synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo™ (axati ...

WALTHAM, Mass., Nov. 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger, Chief Executive Officer of Syndax, as well as members of the Syndax management team, will participate in the following upcoming investor conferences: Guggenheim's Inaugural Healthcare Innovation Conference in Boston, MA with a fireside chat on Wednesday, November 13, 2024, at 1:30 p.m. ...

WALTHAM, Mass., Oct. 29, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercialstage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its third quarter 2024 financial results and provide a business update on Tuesday, November 5, 2024. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Tuesday, November 5, 2024 to discuss the Company's financial ...

"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 materi ...

Syndax Pharmaceuticals (SNDX) closed the last trading session at $23.50, gaining 18.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $35.31 indicates a 50.3% upside potential. The average comprises 13 short-term price targets ranging from a low of $23 to a high of $45, with a standard deviation of $6.28. While the lowest estimate indicates a decline of 2.1% from the current price ...