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 ...

Financial Performance - For the six months ended June 30, 2023, the company reported a net loss of $85.7 million, compared to a net loss of $74.7 million for the same period in 2022, resulting in an accumulated deficit of $778.8 million as of June 30, 2023[62]. - The company has an accumulated deficit of $778.8 million as of June 30, 2023, and anticipates continued significant losses for the next several years[104]. - Net cash used in operating activities for the six months ended June 30, 2023, was $74.6 million, reflecting a net loss of $85.7 million adjusted for non-cash items[106]. - Net cash used in operating activities for the six months ended June 30, 2022, was $82.2 million, primarily due to a net loss of $74.7 million and increased clinical trial activities[107]. Research and Development - Research and development expenses for the three months ended June 30, 2023, increased by $5.0 million, or 17%, to $34.8 million from $29.7 million in the prior year, primarily due to increased employee-related expenses[83]. - Total research and development expenses for the three months ended June 30, 2023, increased by $5.0 million, or 17%, to $34.8 million compared to $29.7 million in the prior year[84]. - Total research and development expenses for the six months ended June 30, 2023, increased by $9.1 million, or 15%, to $68.8 million from $59.8 million in the prior year[90]. - The pivotal Phase 2 portion of AUGMENT-101 is enrolling patients with relapsed/refractory acute leukemias, with an NDA filing expected by the end of 2023[64]. - The company plans to submit a New Drug Application (NDA) for revumenib by the end of 2023, with topline data from a pooled analysis of KMT2Ar cohorts expected in Q3 2023[64]. - The company expects to initiate a trial assessing axatilimab in combination with Jakafi® for chronic graft-versus-host disease by year-end 2023[70]. - Axatilimab demonstrated an overall response rate of 74%, 67%, and 50% across three dose cohorts in the pivotal Phase 2 AGAVE-201 trial for chronic graft-versus-host disease[64]. Operating Expenses - Total operating expenses for the three months ended June 30, 2023, were $49.7 million, an increase of 32% compared to $37.7 million in the same period of 2022[82]. - Total operating expenses for the six months ended June 30, 2023, increased by $21.1 million, or 28%, to $95.7 million from $74.6 million in the prior year[89]. - General and administrative expenses for the three months ended June 30, 2023, rose by $6.9 million, or 87%, to $14.9 million from $8.0 million in the same period last year[85]. Cash and Investments - As of June 30, 2023, the company had cash, cash equivalents, and short and long-term investments totaling $418.3 million, expected to fund operations for at least the next 12 months[96]. - As of June 30, 2023, the company had cash and cash equivalents of $97.3 million and short-term investments of $301.5 million[112]. - Net cash provided by investing activities for the six months ended June 30, 2023, was $93.8 million, resulting from $236.4 million in proceeds from the maturities of available-for-sale securities[108]. - The company entered into a new sales agreement in May 2023, allowing for the issuance and sale of shares with aggregate sales proceeds of up to $200.0 million[98]. Interest Income - Interest income for the three months ended June 30, 2023, increased by 491% to $5.2 million, compared to $0.9 million in the prior year[82]. - Interest income for the three months ended June 30, 2023, increased by $4.3 million to $5.2 million from $0.9 million in the prior year, primarily due to higher interest rates and increased average balances[86]. - Interest income for the six months ended June 30, 2023, increased by $9.2 million to $10.3 million from $1.1 million in the prior year[93]. Market Conditions - The company does not expect significant effects on operating results or cash flows from changes in market interest rates due to the ability to hold investments until maturity[112]. - The company does not believe inflation and changing prices significantly impacted its results of operations for the periods presented[113].

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q1 2023 Earnings Conference Call May 8, 2023 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Neil Gallagher - President and Head of R&D Keith Goldan - Chief Financial Officer Dr. Anjali Ganguli - Chief Business Officer Conference Call Participants Madhu Kumar - Goldman Sachs Eva Privitera - TD Cowen Anupam Rama - JPMorgan Yigal Nochomovitz - Citigroup Peter Lawson - Barclays Kalpit Patel - B. Riley ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Syndax Pharmaceuticals reported a **$41.1 million** net loss for Q1 2023, with total assets at **$459.8 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$459.8 million** as of March 31, 2023, primarily due to reduced cash and investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $57,517 | $74,356 | | Short-term investments | $374,876 | $401,446 | | **Total current assets** | **$441,511** | **$489,786** | | **Total assets** | **$459,826** | **$497,236** | | Total current liabilities | $23,721 | $29,065 | | **Total liabilities** | **$24,321** | **$29,787** | | **Total stockholders' equity** | **$435,505** | **$467,449** | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Q1 2023 net loss increased to **$41.1 million** due to higher operating expenses, partially offset by increased interest income Q1 Financial Performance (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Research and development | $34,054 | $30,022 | | General and administrative | $11,961 | $6,836 | | **Total operating expenses** | **$46,015** | **$36,858** | | Loss from operations | ($46,015) | ($36,858) | | Interest income | $5,076 | $224 | | **Net loss** | **($41,126)** | **($37,169)** | | **Net loss per share** | **($0.59)** | **($0.63)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$39.2 million** in Q1 2023, with overall cash decreasing by **$16.8 million** Cash Flow Summary (in thousands) | Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($39,228) | ($41,931) | | Net cash provided by investing activities | $19,915 | $8,182 | | Net cash provided by financing activities | $2,474 | $557 | | **Net decrease in cash** | **($16,839)** | **($33,192)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail significant accounting policies, key collaborations like Incyte for axatilimab, and license agreements with milestone obligations - The company is a clinical-stage biopharmaceutical firm focused on developing cancer therapies, operating in a single segment[18](index=18&type=chunk) - Entered a collaboration with Incyte for the worldwide development and commercialization of axatilimab. Syndax and Incyte share U.S. profits and losses equally, and global development costs at a 45% (Syndax) / 55% (Incyte) split. Syndax is eligible for up to **$450 million** in milestones plus tiered royalties on ex-U.S. sales[28](index=28&type=chunk)[29](index=29&type=chunk) - The company has significant license agreements with milestone payment obligations: up to **$99.0 million** to Allergan (for revumenib), up to **$119.5 million** to UCB (for axatilimab), and up to **$150.0 million** to Bayer (for entinostat)[33](index=33&type=chunk)[36](index=36&type=chunk)[38](index=38&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Research and development | $2,778 | $1,353 | | General and administrative | $3,460 | $2,125 | | **Total** | **$6,238** | **$3,478** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased operating expenses for Q1 2023 and asserts **$449.0 million** in cash is sufficient for 12 months [Company and Clinical Overview](index=15&type=section&id=Company%20and%20Clinical%20Overview) Syndax focuses on revumenib and axatilimab, with key clinical milestones expected in 2023, including NDA and BLA submissions - The company's two lead product candidates are revumenib (for KMT2Ar acute leukemias and NPM1 mutant AML) and axatilimab (for cGVHD and IPF)[61](index=61&type=chunk) - Key upcoming milestones for revumenib include sharing topline data from the KMT2Ar pooled analysis in Q3 2023 and submitting an NDA by the end of 2023[64](index=64&type=chunk) - Key upcoming milestones for axatilimab include reporting topline data from the pivotal AGAVE-201 trial in mid-2023 and filing a BLA by year-end 2023[64](index=64&type=chunk)[65](index=65&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) Total operating expenses increased **25%** to **$46.0 million** in Q1 2023, driven by higher R&D and G&A costs Comparison of Operations (in thousands) | Item | Q1 2023 | Q1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $34,054 | $30,022 | $4,032 | 13% | | General and administrative | $11,961 | $6,836 | $5,125 | 75% | | **Total operating expenses** | **$46,015** | **$36,858** | **$9,157** | **25%** | | Net loss | ($41,126) | ($37,169) | ($3,957) | 11% | - The increase in R&D expenses was mainly due to a **$4.9 million** rise in employee-related costs and increased manufacturing activities for revumenib, offset by lower license fees[84](index=84&type=chunk)[85](index=85&type=chunk) - The increase in G&A expenses was primarily driven by a **$3.4 million** rise in employee-related expenses and a **$1.2 million** increase in professional fees[87](index=87&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$449.0 million** in cash and investments as of March 31, 2023, deemed sufficient for at least 12 months - The company possessed **$449.0 million** in cash, cash equivalents, and short and long-term investments as of March 31, 2023[91](index=91&type=chunk) - Management asserts that current cash reserves are sufficient to fund operations for at least the next 12 months[91](index=91&type=chunk)[93](index=93&type=chunk) - The company has an active At-the-Market (ATM) program with **$49.7 million** available for future sales as of May 3, 2023[92](index=92&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on its **$432.4 million** cash and investment portfolio, with no material impact expected - The primary market risk is interest rate sensitivity on cash and investments[105](index=105&type=chunk) - Due to the short-term maturities of investments, an immediate **100 basis point** change in interest rates is not expected to have a material effect on the fair market value of the portfolio[105](index=105&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal controls - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[107](index=107&type=chunk) - No material changes to the internal control over financial reporting occurred during the quarter ended March 31, 2023[108](index=108&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) As of March 31, 2023, the company was not party to any material legal or governmental proceedings - As of March 31, 2023, the company was not party to any material legal proceedings[110](index=110&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including clinical development failures, reliance on third parties, financial needs, and intellectual property challenges [Risks Related to Our Business and Industry](index=24&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Success depends on clinical development and approval of product candidates, with risks including trial failures, reliance on third parties, and market acceptance - The company may be unable to complete the development and commercialization of its product candidates, which would significantly harm business prospects[113](index=113&type=chunk)[115](index=115&type=chunk) - The company is dependent on its collaboration with Incyte to develop and commercialize axatilimab; failure by Incyte to perform could terminate or delay the program[122](index=122&type=chunk)[123](index=123&type=chunk) - Reliance on third-party suppliers for manufacturing and distribution poses risks related to capacity, quality control, and regulatory compliance (cGMP)[137](index=137&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk) - Product candidates may cause undesirable side effects that could delay or prevent regulatory approval or limit their commercial use[147](index=147&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=37&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) The company has a history of net losses, an accumulated deficit of **$734.2 million**, and will require substantial additional dilutive capital - The company has incurred net losses since inception (except 2021) and anticipates continued losses. The accumulated deficit was **$734.2 million** as of March 31, 2023[189](index=189&type=chunk)[190](index=190&type=chunk) - The company will require additional capital to finance its operations, and such financing may not be available on acceptable terms, or at all[194](index=194&type=chunk)[195](index=195&type=chunk) - The ability to use net operating loss (NOL) carryforwards may be limited by Section 382 of the Code due to past ownership changes in 2007, 2015, and 2020, and potential future changes[200](index=200&type=chunk) [Risks Related to Intellectual Property](index=40&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Success depends on protecting intellectual property, with risks including patent prosecution challenges, license agreement breaches, and changes in patent law - The company's success is highly dependent on its ability to establish, maintain, and protect patents and other intellectual property rights[203](index=203&type=chunk) - A breach or termination of the UCB license agreement could lead to the loss of development and commercialization rights for axatilimab[216](index=216&type=chunk)[219](index=219&type=chunk) - A breach or termination of the AbbVie (formerly Vitae) license agreement could lead to the loss of rights for revumenib[220](index=220&type=chunk)[223](index=223&type=chunk) - Changes in U.S. patent law, such as the America Invents Act and recent Supreme Court rulings, could increase uncertainties and costs, potentially weakening the company's ability to protect its products[228](index=228&type=chunk)[229](index=229&type=chunk) [Risks Related to Ownership of Our Common Stock and Other General Matters](index=45&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock%20and%20Other%20General%20Matters) Risks include common stock price volatility, potential dilution from future financing, significant control by principal stockholders, and anti-takeover provisions - The market 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 may result in dilution to existing stockholders[244](index=244&type=chunk) - As of March 31, 2023, principal stockholders and management owned approximately **41.4%** of the company's stock, allowing them to exert significant influence over stockholder-approved matters[248](index=248&type=chunk) - Anti-takeover provisions in the company's charter and Delaware law could make an acquisition more difficult, potentially limiting stockholder opportunities for a premium[252](index=252&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and required SEC certifications - Lists exhibits filed with the report, including corporate governance documents, employment agreements, and required SEC certifications[254](index=254&type=chunk)

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2022 Results Conference Call February 28, 2023 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Dr. Briggs Morrison - President and Head, R&D Keith Goldan - Chief Financial Officer Dr. Peter Ordentlich - Chief Scientific Officer Dr. Anjali Ganguli - Chief Business Officer Conference Call Participants Omari Baruti - Goldman Sachs Phil Nadeau - Cowen and Company Priyanka Grover - JPMorgan Ashiq Muba ...

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, 2022 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 ...

Determined to realize a future in which people with cancer live longer and better than ever before Syndax 參 CORPORATE PRESENTATION | JANUARY 2023 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," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forwar ...

Syndax 珍 | --- | --- | |-------|--------------------------| | | Dose: 1mg/kg q2wk | | | n= 23 patients | | | Primary endpoint: ORR* | | | (2014 NIH GVHD criteria) | KPS at enrollment, median (range) 80 (60, 100) 80 (60, 90) 80 (60, 100) • No evidence of end-organ damage, myositis/pancreatitis with enzyme elevations 52% FIBROSIS CSF-1R Circulating Monocyte CSF-1 Circulating Monocyte Macrophage Tissue Fibroblasts Collagen CSF-1R CSF-1R CSF-1 Circulating Monocyte Blood vessel CSF-1R M2 macrophage 17 Myeloablat ...