Financial Data and Key Metrics Changes - The company reported $522 million in cash equivalents and investments as of March 31, expected to provide runway through 2026 [53] - Operating expenses for Q1 were $79.5 million, with R&D expenses at $56.5 million and SG&A expenses at $23 million [82] - For Q2, the company expects R&D expenses to be $50 million to $55 million and total operating expenses to be $80 million to $85 million [54] Business Line Data and Key Metrics Changes - Revumenib received priority review from the FDA for the treatment of adult and pediatric relapsed or refractory KMT2A rearranged acute leukemia, with a PDUFA date of September 26, 2024 [39] - The company completed enrollment in the NPM1 AML cohort of the AUGMENT-101 pivotal trial, with data expected in Q4 2024 [37][68] - Axatilimab's BLA filing was granted priority review for chronic GVHD, with a PDUFA date of August 28, 2024 [71] Market Data and Key Metrics Changes - KMT2Ar and NPM1 acute leukemias represent up to 40% of all AML patients, with an addressable market opportunity of approximately $750 million in the US for relapsed or refractory KMT2Ar acute leukemia [49] - The total addressable market for both KMT2Ar and NPM1 in the relapsed or refractory setting is estimated to approach $2 billion in the US [50] Company Strategy and Development Direction - The company aims to launch two first-in-class products, revumenib and axatilimab, in Q3 2024, focusing on building relationships with healthcare providers and payers [45][46] - The strategy includes in-licensing and developing new molecules with differentiated profiles, emphasizing the importance of capital allocation for future business development [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming product launches and the potential market impact, highlighting the urgency of treatment for patients with acute leukemia [77][78] - The company is actively engaging with payers to ensure timely access and reimbursement for revumenib, anticipating coverage for 90% of lives prior to approval [48][104] Other Important Information - The company is preparing for a significant increase in operating expenses in the second half of the year due to R&D and commercial organization build-out [28] - The company has a robust publication plan to detail the clinical benefits of its products to the prescribing community [44] Q&A Session Summary Question: Importance of NCCN guidelines for new indications - Management plans to engage with the NCCN committee for inclusion in guidelines post-approval, leveraging data presentations at medical congresses [106] Question: Expectations around colorectal cancer data - The company is conducting a Phase 1 trial in metastatic colorectal cancer and plans to provide updates in Q2 [108] Question: Sales force size and overlap of providers - The sales force will be adequately sized to cover 95% of the opportunity, with significant overlap in providers treating both leukemia and chronic GVHD [22][24]

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, 2024 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 ...

Exhibit 99.1 Syndax Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update – NDA filing for revumenib in R/R KMT2Ar acute leukemia granted Priority Review under RTOR; PDUFA action date set for September 26, 2024 – – BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – Enrollment completed in AUGMENT-101 mNPM1 cohort; topline data expected in 4Q24 to potentially support sNDA filing in 1H25 – – Company ...

Organ responses in 0.3 mg/kg Q2W 66% had improvement in skin and joint tightening severity 12 Ab535 is a mouse specific anti-CSF-1R antibody | --- | --- | --- | --- | |--------------------------|-----------------------------------|-----------|------------------------------------------------------------------------------------| | N=135 randomized 2:1 | Axatilimab 0.3 mg/kg Q2W (N=90) | | PRIMARY ENDPOINT ∆ FVC | | to axatilimab or placebo | Placebo Q2W (N=45) | Follow-up | SECONDARY ENDPOINTS Disease progres ...

Financial Data and Key Metrics Changes - In Q4 2023, the company strengthened its balance sheet with an additional $258 million in cash, bringing the total cash on hand to $600 million, which is expected to provide a cash runway through 2026 [12][71] - Operating expenses for Q4 were $77.9 million, consisting of $55.1 million in research and development and $22.8 million in selling, general, and administrative expenses [72] - For Q1 2024, the company expects research and development expenses to be between $56 million and $62 million, and total operating expenses to be between $82 million and $88 million [73] Business Line Data and Key Metrics Changes - The company is focused on pre-launch activities for revumenib and axatilimab, with plans to finalize go-to-market strategies [13] - Revumenib has shown a high overall response rate of 63% in KMT2A acute leukemia patients, with a complete response rate of 23% [23] - Axatilimab received priority review from the FDA, with a PDUFA action date set for August 28, 2024, for chronic graft versus host disease [19] Market Data and Key Metrics Changes - The annual incidence of KMT2A acute leukemia is approximately 2,600 patients, with the majority being refractory to frontline treatments, representing a market opportunity of $750 million in the U.S. [42] - The company estimates that the NPM1 acute leukemia population would be slightly larger than the KMT2A population, creating a total accessible population of 5,000 to 6,500 patients in the relapsed or refractory setting [45] Company Strategy and Development Direction - The company aims to distinguish itself as a commercial-stage biotechnology firm with opportunities to expand beyond initial indications for revumenib and axatilimab [9] - The strategy includes targeting both KMT2A and NPM1 acute leukemias, with plans to explore expansion into solid tumors [46][47] - The company is preparing for the commercialization of two first- and best-in-class products in 2024 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving goals for 2024, highlighting the potential for broad franchise opportunities beyond initial registration indications [77] - The company anticipates a historical year in 2024 with the launch of two significant products, emphasizing the importance of first-mover advantage [14][20] Other Important Information - The company is actively recruiting for its sales force in preparation for the product launches, with plans to have representatives trained before the approvals [82] - The company has a disciplined approach to resource allocation, ensuring financial strength to support its pipeline and product launches [72] Q&A Session Summary Question: Can you comment on expectations for your launch of axatilimab and revumenib? - Management indicated that they will be ready with their sales force prior to the approval of either product, with ongoing recruitment for territory managers [81][82] Question: What are your pre-commercial plans and how do you expect SG&A expenses to grow in 2024? - The company is building out its commercial organization to accommodate both product launches, with SG&A expenses expected to grow to approximately $100 million in 2024 [84][91] Question: Can you address the neutropenia rates observed in the SAVE AML trial? - Management clarified that the observed cytopenia rates are consistent with expectations for the heavily pretreated population included in the trial [96] Question: How do you see the KMT2A launch playing out this year? - Management noted that KMT2A represents a compelling commercial opportunity, with a first-to-market product addressing a dire need in the patient population [115] Question: What are the key efficacy measures you are looking for in the frontline setting for revumenib? - Management emphasized the importance of MRD status, transplant rates, and durable responses as key efficacy measures in the frontline setting [121][126]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 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 2834 32-0162505 (State or Other J ...

Exhibit 99.1 Syndax Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update – BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – NDA for revumenib in R/R KMT2Ar acute leukemia submitted under FDA's RTOR program; PDUFA date assignment expected in 1Q24 – – Enrollment in AUGMENT-101 mNPM1 patient cohort expected to complete in late 1Q/early 2Q; topline data in 4Q24 – – Initiated revumenib ...

Syndax Pharmaceuticals Inc (NASDAQ:SNDX) Q3 2023 Results Conference Call November 2, 2023 4:30 PM ET Company Participants Sharon Klahre - Head of Investor Relations Michael Metzger - Chief Executive Officer Neil Gallagher - President and Head of R&D Keith Goldan - Chief Financial Officer Peter Ordentlich - Chief Scientific Officer Anjali Ganguli - Chief Business Officer Conference Call Participants Brad Canino - Stifel Phil Nadeau - TD Cowen Peter Lawson - Barclays Michael Schmidt - Guggenheim Kalpit Patel ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Syndax Pharmaceuticals, Inc. as of September 30, 2023, and for the three and nine-month periods then ended, including Balance Sheets, Statements of Comprehensive Loss, Statements of Cash Flows, and accompanying Notes to the Financial Statements, prepared in accordance with U.S. GAAP [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets to **$399.2 million** as of September 30, 2023, from **$497.2 million** at year-end 2022, primarily due to a reduction in short-term investments, while total liabilities increased to **$40.0 million** from **$29.8 million**, and total stockholders' equity decreased from **$467.4 million** to **$359.2 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $94,550 | $74,356 | | Short-term investments | $269,006 | $401,446 | | **Total Assets** | **$399,224** | **$497,236** | | **Liabilities & Equity** | | | | Total current liabilities | $39,174 | $29,065 | | Total liabilities | $40,038 | $29,787 | | Total stockholders' equity | $359,186 | $467,449 | | **Total Liabilities & Equity** | **$399,224** | **$497,236** | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported a net loss of **$51.1 million** for the third quarter of 2023, an increase from the **$35.4 million** loss in the same period of 2022, with the net loss for the nine months ended September 30, 2023, reaching **$136.9 million**, compared to **$110.1 million** in the prior year period, driven by higher research and development and general and administrative expenses Operating Results (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $39,087 | $26,901 | $107,906 | $86,658 | | General and administrative | $17,268 | $8,240 | $44,143 | $23,066 | | **Loss from operations** | **$(56,355)** | **$(35,141)** | **$(152,049)** | **$(109,724)** | | **Net loss** | **$(51,146)** | **$(35,403)** | **$(136,887)** | **$(110,144)** | | Net loss per share | $(0.73) | $(0.58) | $(1.97) | $(1.84) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities was **$119.3 million**, net cash provided by investing activities was **$133.9 million** mainly from maturities of investments exceeding purchases, and net cash provided by financing activities was **$5.6 million** primarily from stock option exercises Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(119,252) | $(110,781) | | Net cash provided by (used in) investing activities | $133,899 | $(48,559) | | Net cash provided by financing activities | $5,649 | $8,752 | | **Net increase (decrease) in cash** | **$20,296** | **$(150,588)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on significant accounting policies, collaborative and license agreements, stock-based compensation, and stockholders' equity, highlighting the Incyte collaboration for axatilimab where development costs are shared **45%** by Syndax and **55%** by Incyte, significant license agreements with potential milestone payments, and a nearly doubled year-over-year stock-based compensation expense for the nine-month period - Under the Incyte collaboration, Syndax is responsible for **45%** of shared global and U.S. development costs for axatilimab, while Incyte is responsible for **55%**[26](index=26&type=chunk) - The company has potential future milestone payment obligations of up to **$99.0 million** to Allergan (AbbVie) for Menin Assets, **$119.5 million** to UCB for axatilimab, and **$150.0 million** to Bayer for entinostat[32](index=32&type=chunk)[34](index=34&type=chunk)[36](index=36&type=chunk) Stock-Based Compensation Expense (in thousands) | Period | 2023 | 2022 | | :--- | :--- | :--- | | **Three Months Ended Sep 30** | $8,321 | $4,362 | | **Nine Months Ended Sep 30** | $22,624 | $11,778 | - In May 2023, the company established a new At-the-Market (ATM) equity offering program for up to **$200.0 million**, with no shares sold under this program as of September 30, 2023[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, clinical progress, and strategic outlook, highlighting positive pivotal data for its lead candidates, revumenib and axatilimab, with plans for regulatory submissions by year-end 2023, detailing a significant year-over-year increase in operating expenses driven by advancing clinical programs and pre-commercialization activities, and confirming sufficient capital to fund operations for at least the next **12 months** [Company Overview and Clinical Developments](index=18&type=section&id=Company%20Overview%20and%20Clinical%20Developments) Syndax is a clinical-stage biopharmaceutical company focused on cancer therapies with two lead candidates, revumenib and axatilimab, for which the company announced positive pivotal trial data, initiating an NDA submission for revumenib in R/R KMT2Ar acute leukemia under the FDA's RTOR program and planning a BLA submission for axatilimab in cGVHD by year-end 2023 following positive AGAVE-201 trial results - The company's two lead product candidates are revumenib (for acute leukemias) and axatilimab (for cGVHD and IPF)[62](index=62&type=chunk) - Positive topline data from the pivotal AUGMENT-101 trial of revumenib led to the initiation of an NDA submission, expected to be complete by year-end 2023[65](index=65&type=chunk) - Following positive topline data from the pivotal AGAVE-201 trial, Syndax and its partner Incyte expect to submit a BLA for axatilimab by year-end 2023[66](index=66&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Operating expenses increased significantly for both the three and nine-month periods ended September 30, 2023, compared to 2022, with R&D expenses rising **45%** to **$39.1 million** and G&A expenses rising **110%** to **$17.3 million** for the third quarter, and R&D expenses increasing **25%** to **$107.9 million** and G&A expenses increasing **91%** to **$44.1 million** for the nine-month period, primarily due to higher employee-related costs, professional fees, and clinical and manufacturing activities for the lead programs Comparison of Operating Expenses (in thousands) | Expense Category | Q3 2023 | Q3 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $39,087 | $26,901 | 45% | | General and administrative | $17,268 | $8,240 | 110% | | **Total operating expenses** | **$56,355** | **$35,141** | **60%** | Comparison of Operating Expenses (in thousands) | Expense Category | Nine Months 2023 | Nine Months 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $107,906 | $86,658 | 25% | | General and administrative | $44,143 | $23,066 | 91% | | **Total operating expenses** | **$152,049** | **$109,724** | **39%** | [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company had **$379.3 million** in cash, cash equivalents, and investments, which management believes is sufficient to cover operating expenses and capital requirements for at least the next **12 months**, with a **$200.0 million** ATM program in place for future capital needs, though no shares were sold under it during the quarter, and future capital requirements will depend on clinical trial progress, regulatory outcomes, and commercialization costs - The company had cash, cash equivalents, and short- and long-term investments totaling **$379.3 million** as of September 30, 2023[98](index=98&type=chunk) - Management believes current cash is sufficient to fund operations for at least the next **12 months**[98](index=98&type=chunk)[101](index=101&type=chunk) - A new **$200.0 million** At-the-Market (ATM) program was established in May 2023, with the full amount available as of October 27, 2023[100](index=100&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity related to its cash and investment portfolio, but due to the short-term nature and low-risk profile of its investments, management does not expect a **100 basis point** change in interest rates to have a material effect on its financial position, and inflation is not believed to have had a significant impact on results - The company's primary market risk exposure is to interest rate changes on its **$94.6 million** in cash and cash equivalents and **$284.7 million** in investments[114](index=114&type=chunk) - Due to the short-term maturities of its investments, management believes an immediate **100 basis point** change in interest rates would not have a material effect on the fair market value of its portfolio[114](index=114&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, including the CEO and CFO, the company's disclosure controls and procedures were concluded to be effective as of September 30, 2023, with no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls - Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2023[116](index=116&type=chunk) - There were no material changes to the company's internal control over financial reporting during the third quarter of 2023[117](index=117&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) This section states that as of September 30, 2023, Syndax Pharmaceuticals was not a party to any material legal or arbitration proceedings, and no governmental proceedings were pending or known to be contemplated against the company - As of September 30, 2023, the company was not party to any material legal proceedings[120](index=120&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of the significant risks and uncertainties that could adversely affect the company's business, financial condition, and results of operations, categorized into business and industry, financial position and capital needs, intellectual property, and stock ownership, highlighting dependence on the clinical and commercial success of its two lead product candidates, inherent uncertainties of the regulatory approval process, the need for future financing, and the ability to protect its intellectual property [Risks Related to Our Business and Industry](index=29&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The company's success is highly dependent on the successful clinical development, regulatory approval, and commercialization of its lead candidates, revumenib and axatilimab, facing risks including potential failure to demonstrate safety and efficacy, delays in clinical trials, reliance on the Incyte collaboration for axatilimab, manufacturing dependence on third parties, intense competition, and challenges in achieving market acceptance and reimbursement - The company's prospects are significantly harmed if it is unable to successfully complete clinical development, obtain regulatory approval for, and commercialize its product candidates[123](index=123&type=chunk)[125](index=125&type=chunk) - The company is dependent on its collaboration with Incyte to develop and commercialize axatilimab; failure by Incyte to perform its obligations could substantially delay or terminate the program[133](index=133&type=chunk)[134](index=134&type=chunk) - The company relies on third-party suppliers and Incyte for manufacturing and distribution, and has no direct control over their capacity, quality, or compliance with cGMP regulations[145](index=145&type=chunk)[147](index=147&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=43&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) Syndax has a history of net losses and expects them to continue as it advances its programs, with no product revenue and a requirement for substantial additional capital to fund operations, clinical development, and potential commercialization, and future financing may not be available on acceptable terms, if at all, which could force the company to delay or scale back its plans - The company has incurred net losses since inception (except in 2021) and anticipates continued significant losses for the foreseeable future[196](index=196&type=chunk)[197](index=197&type=chunk) - The company will require additional capital to finance its operations, and if unable to raise funds, may have to delay, scale back, or discontinue development or commercialization of its product candidates[201](index=201&type=chunk)[203](index=203&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards may be limited due to past and potential future ownership changes under Section **382** of the Code[207](index=207&type=chunk) [Risks Related to Intellectual Property](index=45&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success depends on its ability to obtain, maintain, and protect its intellectual property, including risks related to the uncertainty of patent prosecution, potential infringement lawsuits, and the difficulty of enforcing IP rights globally, and is also dependent on its license agreements with UCB for axatilimab and AbbVie (formerly Vitae) for revumenib, where a breach or termination could result in the loss of rights to these candidates - The company's success depends on its ability to establish, maintain, and protect patents and other intellectual property rights for its product candidates[209](index=209&type=chunk) - A breach or termination of the license agreement with UCB could lead to the loss of development and commercialization rights for axatilimab[219](index=219&type=chunk)[222](index=222&type=chunk) - A breach or termination of the license agreement with AbbVie (Vitae) could lead to the loss of development and commercialization rights for revumenib[224](index=224&type=chunk)[227](index=227&type=chunk) [Risks Related to Ownership of Our Common Stock and Other General Matters](index=50&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock%20and%20Other%20General%20Matters) Ownership of the company's common stock involves risks including high price volatility, potential dilution from future equity or debt offerings, and significant influence exerted by principal stockholders and management, alongside risks from unstable market conditions, potential securities litigation, and the need to maintain effective internal controls over financial reporting - The trading price of the company's common stock is highly volatile and subject to wide fluctuations[241](index=241&type=chunk) - Future sales of equity or debt securities to fund operations will result in dilution to existing stockholders[244](index=244&type=chunk) - As of September 30, 2023, executive officers, directors, and **5%+** stockholders beneficially owned approximately **40.4%** of the company's voting stock, allowing them to exert significant influence[248](index=248&type=chunk) [Other Information](index=53&type=section&id=Item%205.%20Other%20Information) This section discloses that during the last fiscal quarter, none of the company's directors or officers adopted or terminated any pre-arranged trading plans for the purchase or sale of the company's securities - No directors or officers adopted or terminated contracts, instructions, or written plans for the purchase or sale of company securities during the last fiscal quarter[253](index=253&type=chunk) [Exhibits](index=54&type=section&id=Item%206.%20Exhibits) This section provides a list of the exhibits filed with the Form 10-Q, including the company's Amended and Restated Certificate of Incorporation and Bylaws, as well as certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act - The report includes a list of filed exhibits, such as charter documents and required officer certifications (Exhibits **31.1**, **31.2**, **32.1**)[255](index=255&type=chunk)

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Sharon Klahre - Head, IR Michael Metzger - CEO Neil Gallagher - President & Head, R&D Keith Goldan - CFO Peter Ordentlich - CSO Anjali Ganguli - CBO Conference Call Participants Phil Nadeau - TD Cowen Anupam Rama - JPMorgan Ashiq Mubarack - Citi Brad Canino - Stifel Michael Schmidt - Guggenheim Peter Lawson - Barclays William Wood - B. Riley Securities Justin Zelin - BTIG Operator Good ...