Financial Data and Key Metrics Changes - In Q2 2025, Syndax reported net revenue of $28.6 million for Revuforge, a 43% increase quarter over quarter, with combined net product sales for Revuforge and Nyktymbo reaching nearly $100 million in the first half of the year [6][7][19] - Nyktymbo generated $36.2 million in net revenue in its first full quarter, significantly up from $13.6 million in the first two months of launch [15][40] - The company maintains a strong financial position with $518 million in cash and equivalents as of June 30, 2025, and expects to reach profitability with current resources [43][44] Business Line Data and Key Metrics Changes - Revuforge has treated over 500 patients, with approximately 90% of usage in KMT2A patients, and is increasingly being used in earlier lines of therapy [10][20] - Nyktymbo is already profitable for Syndax, contributing $9.4 million in collaboration revenue in Q2 2025 [16][41] - The average treatment duration for Revuforge is expected to build to 4-6 months in the first year and potentially 6-12 months in the second year as treatment patterns mature [23][68] Market Data and Key Metrics Changes - Revuforge has penetrated 25% of the annual 2,000 patient incidents of relapsed-refractory KMT2A acute leukemia, with expectations to reach 50% by year-end [20][83] - Nyktymbo is positioned in a $2 billion market for chronic GVHD treatments, with a total addressable market of $2 billion based on current indications [28][49] - The company anticipates expanding Revuforge's market opportunity to over $2 billion with the approval of its supplemental new drug application for relapsed-refractory mutant NPM1 AML [13][14] Company Strategy and Development Direction - Syndax aims to extend its leadership in the menin inhibition space, with ongoing trials for Revuforge in both frontline and relapsed settings [35][37] - The company is focused on developing Nyktymbo for additional patient populations, including idiopathic pulmonary fibrosis (IPF) [38] - Syndax's strategy includes maintaining stable operating expenses while investing in the successful launches of Revuforge and Nyktymbo [41][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's trajectory towards profitability, driven by strong physician enthusiasm and robust adoption of both products [45][46] - The anticipated approval of the supplemental new drug application for Revuforge is expected to significantly enhance its market position [13][96] - Management highlighted the importance of treatment duration and patient outcomes as key drivers for future growth [90] Other Important Information - The company has strengthened its leadership team with the addition of Nick Botwood as Head of R&D and Chief Medical Officer [17] - Syndax has retained worldwide rights to Revuforge, with patent protection extending through at least the late 2030s [48] Q&A Session Summary Question: Path to profitability and assumptions for top line growth - Management indicated that profitability is expected with existing resources, and both product launches are outperforming expectations [52][53] Question: Patients proceeding to transplant and maintenance therapy - Management noted that patients typically proceed to transplant after 2-3 cycles of treatment, with expectations for a high percentage of patients to return to maintenance therapy [57][62] Question: Treatment duration observations in real-world practice - Management confirmed that the average treatment duration is expected to be 4-6 months in the first year, potentially extending to 6-12 months as more patients are treated earlier [64][68] Question: KMT-2A patient penetration and revenue growth - Management clarified that there is still significant growth potential in the KMT-2A population, with expectations to reach 50% penetration by year-end [78][88] Question: FDA approval confidence and remaining open items - Management expressed confidence in the FDA approval process, indicating that discussions with the agency have been positive [95][99]

Financial Data and Key Metrics Changes - In Q2 2025, Syndax Pharmaceuticals reported net product sales of nearly $100 million for Revuforge and Nyktymbo, significantly exceeding expectations [5] - Revuforge net revenue increased by 43% quarter over quarter to $28.6 million, despite one-third of patients pausing treatment for stem cell transplants [5][39] - Nyktymbo generated $36.2 million in net revenue in its first full quarter, up from $13.6 million in the first two months of launch [13][39] Business Line Data and Key Metrics Changes - Revuforge has treated over 500 patients, with approximately 90% of usage in KMT2A patients, and has penetrated 25% of the annual 2,000 patient incidents [8][18] - Nyktymbo is already profitable for Syndax, contributing $9.4 million in collaboration revenue in Q2 2025 [14][40] - The average treatment duration for Revuforge is expected to increase to 6-12 months as treatment patterns mature [21][66] Market Data and Key Metrics Changes - The market opportunity for Revuforge is projected to exceed $5 billion across relapsed refractory and frontline settings [24] - The addressable market for Revuforge in the U.S. is expected to increase to $2 billion with the anticipated approval of the supplemental new drug application (sNDA) for relapsed-refractory mutant NPM1 AML [12] - Nyktymbo targets a $2 billion total addressable market in chronic GVHD, with a current indication for 6,500 patients requiring three or more lines of therapy [26] Company Strategy and Development Direction - Syndax aims to expand Revuforge into earlier lines of therapy and additional patient populations, enhancing its market position [6][12] - The company is focused on maintaining a stable operating expense base while fully funding strategic priorities [39][42] - Syndax is advancing its leadership in menin inhibition and exploring additional indications for Nyktymbo, including idiopathic pulmonary fibrosis [37][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability with current resources, citing strong performance from both product launches [43][45] - The company anticipates continued growth driven by strong physician enthusiasm and robust adoption of Revuforge and Nyktymbo [45][48] - Management highlighted the importance of clinical data and physician feedback in driving future growth and market penetration [29][31] Other Important Information - Syndax has a strong financial position with $518 million in cash and equivalents as of June 30, 2025 [43] - The company has strengthened its leadership team with the addition of Dr. Nick Botwood as Head of R&D and Chief Medical Officer [15] Q&A Session Summary Question: Path to profitability and assumptions for REVIVORGE and Nyktymbo - Management indicated that profitability is expected with existing resources, and both product launches are outperforming expectations [51][52] Question: Patients proceeding to transplant and maintenance therapy - Management noted that patients typically proceed to transplant after 2-3 cycles of treatment, and they expect a high percentage of patients to return for maintenance therapy [55][60] Question: Treatment duration observations in real-world practice - Management confirmed that the average treatment duration is expected to be 4-6 months in the first year, potentially increasing to 6-12 months as treatment patterns mature [62][66] Question: KMT-2A patient penetration and revenue growth - Management stated that they expect to reach 50% penetration of the identified KMT-2A population by the end of the year, with significant growth potential remaining [76][80] Question: FDA approval confidence and remaining open items - Management expressed confidence in the FDA approval process, indicating good progress and consistent dialogue with the agency [92][96]

Financial Performance - Revuforj net revenue in 2Q25 reached $28.6 million, representing a 43% quarter-over-quarter growth[6] - Niktimvo net revenue reported by Incyte in 2Q25 was $36.2 million, a substantial increase from $13.6 million in the first two months of Q1 launch[9] - Syndax reported $9.4 million in collaboration revenue from Niktimvo in 2Q25, achieving profitability in the first full quarter[9] - Syndax holds a strong financial position with $518 million in cash and equivalents as of June 30, 2025[28] Product Pipeline and Market Opportunity - Syndax estimates a $5B+ Total Addressable Market (TAM) for Revuforj and another $5B+ TAM for Niktimvo, indicating a $10B+ market opportunity across R/R and frontline indications[4, 30] - The initial Niktimvo indication represents a $2B U S market opportunity, with potential for label and geographic expansion leading to a $5B+ TAM[19, 20] - Approximately 33% of KMT2A patients are estimated to have proceeded to hematopoietic stem cell transplantation (HSCT) following Revuforj treatment[6, 12] Clinical Data and Development - Phase 2 Relapsed/Refractory (R/R) mNPM1 AML data for Revumenib showed a 26% (20/77) CR+CRh rate and a 48% (37/77) Overall Response Rate (ORR)[26] - Phase 1 R/R NUP98r AML data for Revumenib showed a 60% (3/5) ORR[26] - Over 80% of bone marrow transplant centers have ordered Niktimvo[18]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported Q2 2025 revenues of **$38.0 million** and a net loss of **$71.8 million**, with **$517.9 million** in cash and investments as of June 30, 2025 Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents & investments | $517,860 | $692,404 | | Total Assets | $596,149 | $724,816 | | Total Liabilities | $438,725 | $436,692 | | Total Stockholders' Equity | $157,424 | $288,124 | Consolidated Statements of Comprehensive Loss Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $37,958 | $3,500 | $57,753 | $3,500 | | Product revenue, net | $28,600 | $— | $48,642 | $— | | Collaboration revenue, net | $9,358 | $— | $9,111 | $— | | R&D Expenses | $62,227 | $48,655 | $123,863 | $105,147 | | SG&A Expenses | $43,805 | $29,061 | $84,836 | $52,083 | | Net Loss | $(71,847) | $(68,063) | $(156,693) | $(140,463) | | Net Loss Per Share (Basic & Diluted) | $(0.83) | $(0.80) | $(1.82) | $(1.65) | Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(182,957) | $(155,193) | | Net cash provided by (used in) investing activities | $136,029 | $(37,649) | | Net cash provided by financing activities | $1,481 | $2,844 | | Net decrease in cash | $(45,447) | $(189,998) | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Significant notes detail the Incyte collaboration for Niktimvo, a **$350 million** royalty financing deal with Royalty Pharma, and **$24.2 million** in H1 2025 stock-based compensation - The company collaborates with Incyte on axatilimab (Niktimvo), sharing **U.S. profits and losses equally** and global development costs with a **45% (Syndax) / 55% (Incyte) split**[39](index=39&type=chunk)[40](index=40&type=chunk) - A November 2024 agreement with Royalty Pharma provided a **$350 million upfront payment** for a **13.8% royalty** on U.S. net sales of Niktimvo, capped at **$822.5 million**, accounted for as a liability[61](index=61&type=chunk)[62](index=62&type=chunk) Stock-Based Compensation Expense (in thousands) | Period | R&D | SG&A | Total | | :--- | :--- | :--- | :--- | | **Q2 2025** | $4,196 | $9,591 | $13,787 | | **Q2 2024** | $4,318 | $5,578 | $9,896 | | **H1 2025** | $7,864 | $16,303 | $24,167 | | **H1 2024** | $8,461 | $10,334 | $18,795 | - As of June 30, 2025, **$92.2 million** in unrecognized compensation costs for unvested stock options and RSUs are expected to be recognized over **2.57 years**[69](index=69&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights strong revenue growth from Revuforj and Niktimvo launches, increased operating expenses due to commercialization and trials, and sufficient liquidity with **$517.9 million** in cash [Business Update](index=22&type=section&id=Business%20Update) The company reports strong commercial performance with **Revuforj net revenue up 43%** to **$28.6 million** in Q2 2025, FDA Priority Review for Revuforj, and **Niktimvo total net revenue of $36.2 million** - Revuforj net revenue reached **$28.6 million** in Q2 2025, representing a **43% increase** quarter-over-quarter[81](index=81&type=chunk) - The FDA granted Priority Review for Revuforj's sNDA in R/R mNPM1 AML, with a PDUFA target action date of **October 25, 2025**[81](index=81&type=chunk) - Niktimvo generated **$36.2 million** in total net revenue in Q2 2025, with Syndax's collaboration revenue share at **$9.4 million**[83](index=83&type=chunk) - Enrollment continues for the MAXPIRe Phase 2 trial of axatilimab in IPF, with topline data expected in the **second half of 2026**[89](index=89&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Q2 2025 total revenues reached **$38.0 million**, driven by Revuforj and Niktimvo, while R&D expenses increased by **$13.6 million** and SG&A expenses rose by **$14.7 million** Comparison of Results of Operations (in thousands) | Line Item | Q2 2025 | Q2 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Total Revenues | $37,958 | $3,500 | $34,458 | | R&D Expenses | $62,227 | $48,655 | $13,572 | | SG&A Expenses | $43,805 | $29,061 | $14,744 | | Loss from Operations | $(69,353) | $(74,216) | $(4,863) | | Net Loss | $(71,847) | $(68,063) | $3,784 | - H1 2025 R&D expense increase was primarily due to revumenib and axatilimab trials, a **$5.0 million** sNDA submission milestone, and a **$10 million** Phase III combination study milestone[109](index=109&type=chunk)[111](index=111&type=chunk) - H1 2025 SG&A expenses rose due to a **$7.3 million** increase in commercial-related costs and an **$18.3 million** increase in personnel costs for Revuforj and Niktimvo commercialization[110](index=110&type=chunk)[112](index=112&type=chunk)[122](index=122&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$517.9 million** in cash and investments as of June 30, 2025, with **$183.0 million** net cash used in H1 2025 operating activities, and **$157.9 million** available under its ATM program - Net cash used in operating activities increased to **$183.0 million** in H1 2025 from **$155.2 million** in H1 2024, driven by higher operating net loss and working capital changes[116](index=116&type=chunk)[117](index=117&type=chunk) - The company received a **$350 million upfront payment** in November 2024 from Royalty Pharma for Niktimvo revenue stream rights[123](index=123&type=chunk) - As of June 30, 2025, **$157.9 million** remained available under the 2023 at-the-market (ATM) equity offering program[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$517.9 million** cash and investment portfolio, which is managed for liquidity and principal preservation - The company's primary market risk is interest rate sensitivity on its **$108.6 million** in cash and cash equivalents and **$409.2 million** in short and long-term investments[135](index=135&type=chunk) - Investment guidelines prioritize safety and liquidity, and due to short-term maturities, management anticipates no significant impact from interest rate changes[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were effective as of **June 30, 2025**[138](index=138&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter ended **June 30, 2025**[139](index=139&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, the company was not involved in any material legal or arbitration proceedings, with no contingent liabilities recorded - As of **June 30, 2025**, the company was not a party to any material legal proceedings[141](index=141&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported in the current period, referring investors to prior Form 10-K and Q1 2025 Form 10-Q filings - No material changes to risk factors were reported from those disclosed in the **2024 Form 10-K** and **Q1 2025 Form 10-Q**[142](index=142&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025 for company securities - No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q2 2025[143](index=143&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) The section lists exhibits filed with the Form 10-Q, including corporate governance documents and required CEO and CFO certifications - The report includes standard corporate governance documents and required officer certifications as exhibits[144](index=144&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) [Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) The company reported strong Q2 2025 results driven by significant sales momentum for Revuforj and Niktimvo **Q2 2025 Key Financial Highlights** | Metric | Value | | :----- | :---- | | Revuforj Net Revenue | $28.6 million | | Revuforj QoQ Growth | 43% | | Niktimvo Net Revenue (Incyte reported) | $36.2 million | | Syndax Collaboration Revenue (Niktimvo) | $9.4 million | | Cash, Cash Equivalents & Investments | $517.9 million | - The company expects to fund operations to profitability with current cash, anticipated product revenue, and interest income[3](index=3&type=chunk)[4](index=4&type=chunk) - Revuforj's sNDA for R/R mNPM1 AML was granted **Priority Review** by the FDA, with a PDUFA action date of October 25, 2025[3](index=3&type=chunk)[4](index=4&type=chunk) [Recent Business Highlights and Anticipated Milestones](index=2&type=section&id=Recent%20Business%20Highlights%20and%20Anticipated%20Milestones) [Revuforj® (revumenib) Updates](index=2&type=section&id=Revuforj%C2%AE%20(revumenib)%20Updates) Revuforj demonstrated strong commercial growth and regulatory progress while advancing multiple clinical trials [Commercial Performance & Regulatory Milestones](index=2&type=section&id=Revuforj%20Commercial%20Performance%20%26%20Regulatory%20Milestones) Revuforj achieved substantial net revenue growth and its sNDA for R/R mNPM1 AML received Priority Review **Revuforj Net Revenue** | Period | Net Revenue | | :----- | :---------- | | Q2 2025 | $28.6 million | | Q1 2025 | (Implied $19.99 million based on 43% growth) | | QoQ Growth | 43% | - The U.S. FDA granted **Priority Review** to the sNDA for Revuforj for the treatment of R/R mutant NPM1 (mNPM1) acute myeloid leukemia (AML), with a PDUFA target action date of **October 25, 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) [Clinical Trial Data & Ongoing Studies](index=2&type=section&id=Revuforj%20Clinical%20Trial%20Data%20%26%20Ongoing%20Studies) New data showed positive response rates, and multiple trials are ongoing to evaluate revumenib in various settings - Additional results from the pivotal Phase 2 AUGMENT-101 trial in R/R mNPM1 AML showed an **Overall Response Rate (ORR) of 48%** and a **Complete Remission (CR) plus CRh rate of 26%**, with **63% of CR/CRh patients being MRD negative**[5](index=5&type=chunk) - Ongoing trials for revumenib include EVOLVE-2, BEAT AML (showing **67% CR rate**), and SAVE (showing **82% ORR**), with data from a Phase 1 trial with intensive chemotherapy expected in **Q4 2025**[6](index=6&type=chunk) - Two REVEAL trials evaluating revumenib in combination with standard of care are expected to initiate in **Q4 2025**, with data from a trial in metastatic MSS colorectal cancer (CRC) expected by **year-end 2025**[8](index=8&type=chunk) [Niktimvo™ (axatilimab-csfr) Updates](index=4&type=section&id=Niktimvo%E2%84%A2%20(axatilimab-csfr)%20Updates) Niktimvo achieved significant launch revenue and is progressing in clinical trials for chronic GVHD and IPF [Commercial Performance & Collaboration](index=4&type=section&id=Niktimvo%20Commercial%20Performance%20%26%20Collaboration) Niktimvo generated significant net revenue in its first full quarter, resulting in substantial collaboration revenue **Niktimvo Net Revenue & Syndax Collaboration** | Metric | Q2 2025 Value | | :----- | :------------ | | Niktimvo Net Revenue (Incyte) | $36.2 million | | Niktimvo Q1 2025 Net Revenue (Incyte) | $13.6 million | | Syndax Collaboration Revenue | $9.4 million | - Niktimvo was launched in the U.S. in late January 2025 for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy[8](index=8&type=chunk) [Clinical Trial Data & Ongoing Studies](index=4&type=section&id=Niktimvo%20Clinical%20Trial%20Data%20%26%20Ongoing%20Studies) Pivotal trial data highlighted robust responses, with ongoing combination trials and a Phase 2 IPF study - Data from the pivotal AGAVE-201 trial presented in June 2025 highlighted **robust and rapid responses** in patients with chronic GVHD[8](index=8&type=chunk) - Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing[12](index=12&type=chunk) - Enrollment is ongoing in the MAXPIRe Phase 2 trial in idiopathic pulmonary fibrosis (IPF), with completion expected in **Q4 2025** and topline data anticipated in **H2 2026**[12](index=12&type=chunk) [Corporate Updates](index=5&type=section&id=Corporate%20Updates) [Management Changes](index=5&type=section&id=Management%20Changes) The company appointed a new Head of R&D and Chief Medical Officer, and a board member resigned - Dr. Nick Botwood was appointed as Head of Research and Development and Chief Medical Officer in May 2025[12](index=12&type=chunk) - William Meury resigned from the Board of Directors in June 2025 to assume the role of President and CEO at Incyte, the company's collaboration partner[12](index=12&type=chunk) [Second Quarter 2025 Financial Results](index=5&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Balance Sheet Highlights](index=5&type=section&id=Balance%20Sheet%20Highlights) The company maintained a strong cash position of over $500 million as of June 30, 2025 **Balance Sheet Highlights (as of June 30, 2025)** | Metric | Value | | :----- | :---- | | Cash, cash equivalents, and short and long-term investments | $517.9 million | | Common shares and prefunded warrants outstanding | 86.3 million | [Statement of Operations Highlights](index=5&type=section&id=Statement%20of%20Operations%20Highlights) Q2 2025 total revenue reached $38.0 million, driven by product and collaboration revenue **Q2 2025 Total Revenue Breakdown** | Revenue Type | Amount | | :----------- | :----- | | Total Revenue | $38.0 million | | Revuforj Net Product Revenue | $28.6 million | | Niktimvo Collaboration Revenue | $9.4 million | [Operating Expenses](index=6&type=section&id=Operating%20Expenses) Operating expenses increased year-over-year due to clinical trial activities and commercial launch support **Operating Expenses (Three Months Ended June 30)** | Expense Type | 2025 (in thousands) | 2024 (in thousands) | Change (YoY) | | :----------- | :------------------ | :------------------ | :----------- | | Research and development | $62,227 | $48,655 | +$13,572 | | Selling, general and administrative | $43,805 | $29,061 | +$14,744 | - The increase in R&D expenses was primarily due to multiple revumenib trials, a milestone payment to AbbVie, and medical affairs activities supporting Revuforj[13](index=13&type=chunk) - The increase in SG&A expenses was primarily due to higher employee-related expenses and professional fees to support the U.S. commercial launch of Revuforj[14](index=14&type=chunk) [Net Loss](index=6&type=section&id=Net%20Loss) The company reported an increased net loss of $71.8 million for Q2 2025 compared to the prior year **Net Loss Attributable to Common Stockholders (Three Months Ended June 30)** | Metric | 2025 | 2024 | | :----- | :--- | :--- | | Net Loss | $(71.8) million | $(68.1) million | | Net Loss Per Share | $(0.83) | $(0.80) | [Financial Guidance](index=6&type=section&id=Financial%20Guidance) [Expense Outlook & Profitability](index=6&type=section&id=Expense%20Outlook%20%26%20Profitability) The company maintained its full-year expense guidance and expects to reach profitability with current cash **Operating Expense Guidance (Excluding Non-Cash Stock Compensation)** | Period | Expected Range | | :----- | :------------- | | Q3 2025 (R&D + SG&A) | $95 to $100 million | | Full Year 2025 (R&D + SG&A) | $370 to $390 million | - The full year 2025 guidance of **$370 to $390 million** (excluding non-cash stock compensation) represents no change to prior guidance[16](index=16&type=chunk) - Syndax expects its operating expense base to remain stable over the next few years, enabling the company to **reach profitability** with its cash, product revenue, and interest income[17](index=17&type=chunk) [Conference Call and Webcast](index=6&type=section&id=Conference%20Call%20and%20Webcast) [Product Information](index=7&type=section&id=Product%20Information) [About Revuforj® (revumenib)](index=7&type=section&id=About%20Revuforj%C2%AE%20(revumenib)) Revuforj is a first-in-class menin inhibitor with FDA approval and multiple regulatory designations - Revuforj (revumenib) is an oral, first-in-class menin inhibitor, FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation[20](index=20&type=chunk) - The FDA granted **Priority Review** to Syndax's sNDA for revumenib for the treatment of R/R mNPM1 AML, reviewed under the Real-Time Oncology Review (RTOR) program[21](index=21&type=chunk) - Revumenib has received **Orphan Drug Designation**, **Fast Track designation**, and **Breakthrough Therapy Designation** for various acute leukemia indications[23](index=23&type=chunk)[24](index=24&type=chunk) [About Niktimvo™ (axatilimab-csfr)](index=8&type=section&id=About%20Niktimvo%E2%84%A2%20(axatilimab-csfr)) Niktimvo is a first-in-class CSF-1R antibody for chronic GVHD, co-developed with Incyte - Niktimvo (axatilimab-csfr) is a first-in-class CSF-1R-blocking antibody approved for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy[25](index=25&type=chunk) - Syndax holds an exclusive worldwide co-development and co-commercialization license agreement with Incyte for axatilimab[26](index=26&type=chunk) [About the Real-Time Oncology Review Program (RTOR)](index=8&type=section&id=About%20the%20Real-Time%20Oncology%20Review%20Program%20(RTOR)) The RTOR program is an FDA initiative designed to expedite the review of oncology drugs - RTOR provides a more efficient review process for oncology drugs, allowing for early availability of safe and effective treatments through close engagement with the applicant[28](index=28&type=chunk) [About Syndax](index=8&type=section&id=About%20Syndax) [Company Overview](index=8&type=section&id=Company%20Overview) Syndax is a commercial-stage biopharmaceutical company focused on advancing innovative cancer therapies - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company with FDA-approved Revuforj (menin inhibitor) and Niktimvo (CSF-1 receptor blocking antibody)[29](index=29&type=chunk)[30](index=30&type=chunk) - The company is conducting several clinical trials to unlock the full potential of its pipeline[30](index=30&type=chunk) [Forward-Looking Statements](index=9&type=section&id=Forward-Looking%20Statements) [Additional Information](index=10&type=section&id=Additional%20Information) [Financial Statements (Unaudited)](index=11&type=section&id=Financial%20Statements%20(Unaudited)) [Condensed Consolidated Balance Sheets](index=11&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show key financial positions as of June 30, 2025, compared to December 31, 2024 **Condensed Consolidated Balance Sheets (Unaudited, In thousands)** | Metric | June 30, 2025 | December 31, 2024 | | :----- | :------------ | :---------------- | | Cash, cash equivalents, short and long-term investments | $517,860 | $692,404 | | Total assets | $596,149 | $724,816 | | Total liabilities | $438,725 | $436,692 | | Total stockholders' equity | $157,424 | $288,124 | | Common stock outstanding | 86,059,077 | 85,694,443 | [Condensed Consolidated Statements of Operations](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations show increased revenue and a higher net loss for the three and six-month periods **Condensed Consolidated Statements of Operations (Unaudited, In thousands, except per share data)** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product revenue, net | $28,600 | — | $48,642 | — | | Collaboration revenue, net | $9,358 | — | $9,111 | — | | Milestone and license revenue | — | $3,500 | — | $3,500 | | Total revenue | $37,958 | $3,500 | $57,753 | $3,500 | | Total operating expenses | $107,311 | $77,716 | $210,863 | $157,230 | | Net loss | $(71,847) | $(68,063) | $(156,693) | $(140,463) | | Basic loss per share | $(0.83) | $(0.80) | $(1.82) | $(1.65) |

Core Insights - Syndax Pharmaceuticals reported strong financial results for Q2 2025, with significant growth in net revenues from its products Revuforj and Niktimvo, indicating a positive trajectory towards profitability [2][3][4]. Financial Performance - Revuforj (revumenib) generated $28.6 million in net revenue for Q2 2025, reflecting a 43% increase compared to Q1 2025 [4][8]. - Niktimvo (axatilimab-csfr) achieved $36.2 million in net revenue in its first full quarter post-launch, with Syndax recording $9.4 million in collaboration revenue from this product [3][11]. - Total revenue for Q2 2025 was reported at $38.0 million, combining Revuforj and Niktimvo revenues [8]. - The company had cash, cash equivalents, and investments totaling $517.9 million as of June 30, 2025, which is expected to support operations until profitability [7][14]. Product Updates - Revuforj is under Priority Review by the FDA for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia (mNPM1 AML), with a PDUFA action date set for October 25, 2025 [4][17]. - Niktimvo is positioned as a treatment for chronic graft-versus-host disease (GVHD) and has shown rapid sales growth since its launch [11][21]. Clinical Trials and Research - Multiple ongoing clinical trials for revumenib are evaluating its efficacy in various acute leukemia settings, including pivotal Phase 3 trials [5][18]. - Recent data from the AUGMENT-101 trial indicated an overall response rate of 48% for patients with R/R mNPM1 AML, with a complete remission rate of 26% [4][5]. Expense Management - Research and development expenses increased to $62.2 million in Q2 2025, up from $48.7 million in the same period last year, primarily due to costs associated with revumenib trials [9]. - Selling, general, and administrative expenses rose to $43.8 million from $29.1 million year-over-year, reflecting increased marketing efforts for Revuforj [10]. Future Outlook - The company anticipates stable operating expenses over the next few years, which, combined with product revenues, is expected to lead to profitability [14]. - For Q3 2025, total expenses are projected to be between $95 million and $100 million, excluding non-cash stock compensation [13].

Syndax Pharmaceuticals (SNDX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system ...

Group 1 - Shares of Syndax Pharmaceuticals (SNDX) have increased by 2.2% over the past four weeks, closing at $9.57, with a mean price target of $32.33 indicating a potential upside of 237.8% [1] - The mean estimate consists of 12 short-term price targets with a standard deviation of $10.46, where the lowest estimate of $17.00 suggests a 77.6% increase, and the highest estimate of $45.00 indicates a potential surge of 370.2% [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements, as the Zacks Consensus Estimate for the current year has increased by 0.5% over the past month [11][12] Group 2 - SNDX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential upside [13] - While consensus price targets may not be reliable indicators of actual stock gains, they can provide a directional guide for price movement [14]

Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on advancing innovative cancer therapies [3] - The company's pipeline includes FDA-approved therapies such as Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [3] Upcoming Financial Results - Syndax Pharmaceuticals will report its second quarter 2025 financial results and provide a business update on August 4, 2025 [1] - A conference call and live audio webcast will be hosted by the management at 4:30 p.m. ET on the same day [1] Accessing the Conference Call - The live audio webcast and accompanying slides can be accessed through the Events & Presentations page on the company's website [2] - Domestic and international dial-in numbers are provided for the conference call, with a specific Conference ID: Syndax2Q25 [2] - A replay of the conference call will be available approximately 24 hours after the event and will remain accessible for 90 days [2]

Group 1 - The article emphasizes that investing is a learning process, where failures serve as tuition and successes contribute to lessons learned [1] - The author has approximately five years of focused research on various stocks, with a primary emphasis on healthcare stocks in recent years [1] Group 2 - The author has a beneficial long position in the shares of Syndax, indicating a personal investment interest [2] - The article expresses the author's own opinions and is not influenced by any business relationships with companies mentioned [2]