Syndax(SNDX) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements 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 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][40] - 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][62] 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] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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] - 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] - Niktimvo generated $36.2 million in total net revenue in Q2 2025, with Syndax's collaboration revenue share at $9.4 million[83] - Enrollment continues for the MAXPIRe Phase 2 trial of axatilimab in IPF, with topline data expected in the second half of 2026[89] Results of Operations 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][111] - 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][112][122] Liquidity and Capital Resources 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][117] - The company received a $350 million upfront payment in November 2024 from Royalty Pharma for Niktimvo revenue stream rights[123] - As of June 30, 2025, $157.9 million remained available under the 2023 at-the-market (ATM) equity offering program[132] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] - Investment guidelines prioritize safety and liquidity, and due to short-term maturities, management anticipates no significant impact from interest rate changes[136] Item 4. Controls and Procedures 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] - No material changes to internal control over financial reporting occurred during the quarter ended June 30, 2025[139] PART II. OTHER INFORMATION Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] Item 5. Other Information 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] Item 6. Exhibits 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]