Syndax Pharma Files Q3 2024 10-Q, Cites Bayer & Allergan Deals

TL;DR

Syndax Q3 10-Q out. R&D expenses up, mentions Bayer, Allergan deals. Check financials.

AI Summary

Syndax Pharmaceuticals Inc. filed a 10-Q for the period ending September 30, 2024. The company reported research and development expenses for the nine months ended September 30, 2024. Key agreements mentioned include license agreements with Bayer Pharma AG, Eddingpharm Investment, and Allergan. The filing also references Vitae Pharmaceuticals Inc.

Why It Matters

This filing provides an update on Syndax Pharmaceuticals' financial performance and ongoing business activities, including significant licensing agreements that could impact future revenue and drug development.

Risk Assessment

Risk Level: medium — The company is in the pharmaceutical sector, which is inherently risky due to long development cycles, regulatory hurdles, and clinical trial outcomes.

Key Numbers

• 2024-09-30 — Reporting Period End Date (Covers the third quarter of 2024)
• 2024-01-01 — Start Date for R&D Expenses (Nine months ended September 30, 2024)
• 2023-09-30 — Comparative Period End Date (For common stock reporting)

Key Players & Entities

• Syndax Pharmaceuticals Inc (company) — Filer
• Bayer Pharma AG (company) — Licensing Partner
• Eddingpharm Investment (company) — Licensing Partner
• Allergan (company) — Licensing Partner
• Vitae Pharmaceuticals Inc (company) — Mentioned Entity

FAQ

Key Financial Figures

• $0.0001 — he registrant's Common Stock, par value $0.0001 per share, outstanding. FORWARD-LOOKI

Filing Documents

• sndx-20240930.htm (10-Q) — 1915KB
• sndx-ex31_1.htm (EX-31.1) — 13KB
• sndx-ex31_2.htm (EX-31.2) — 14KB
• sndx-ex32_1.htm (EX-32.1) — 12KB
• 0000950170-24-121439.txt ( ) — 8037KB
• sndx-20240930.xsd (EX-101.SCH) — 1037KB
• sndx-20240930_htm.xml (XML) — 1666KB

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements other than statements of historical fact are "forward-looking statements" for purposes of this Quarterly Report on Form 10-Q. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions.

Forward-looking statements include, but are not limited to, statements about

Forward-looking statements include, but are not limited to, statements about: our estimates regarding our expenses, future revenues, anticipated capital requirements and our needs for additional financing; the commercialization of NIKTIMVO (axatilimab-csfr) for treatment of chronic graft versus host disease, or cGVHD, including the estimated timeline for launch in the United States; the initiation, cost, timing, progress and results of our research and development activities, clinical trials and preclinical studies; our ability to replicate results in future clinical trials; our expectations regarding the potential safety, efficacy or clinical utility of our product candidates as well as the potential use of our product candidates to treat various cancer indications and fibrotic diseases; our ability to obtain and maintain regulatory approval for our product candidates and the timing or likelihood of regulatory filings and approvals for such candidates; our ability to maintain our licenses with UCB Biopharma Sprl, and Vitae Pharmaceuticals, LLC, a subsidiary of AbbVie Inc.; the success of our collaboration with Incyte Corporation, or Incyte, to further develop and commercialize axatilimab; the potential milestone and royalty payments under certain of our license agreements; the implementation of our strategic plans for our business and development of our product candidates; the scope of protection we establish and maintain for intellectual property rights covering our product candidates and our technology; the market adoption of Niktimvo and our other product candidates by physicians and patients; developments relating to our competitors and our industry; and the impact of geo-political actions, including war or the perception that hostilities may be imminent (such as the ongoing wars between Russia and Ukraine and Hamas and Israel as well as the conflicts in the Middle East, including between Israel and Hezbollah), adverse global economi

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION Item 1. Unaudited Financial Statements: Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 1 Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023 2 Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023 3 Notes to Condensed Consolidated Financial Statements 4 Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 14 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 22 Item 4.

Controls and Procedures

Controls and Procedures 22

OTHER INFORMATION

PART II. OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 24 Item 1A.

Risk Factors

Risk Factors 24 Item 5. Other Information 52 Item 6. Exhibits 54 iii

: FINANCI AL INFORMATION

Part I: FINANCI AL INFORMATION

: Financi al Statements

Item 1: Financi al Statements SYNDAX PHARMACEUTICALS, INC. (unaudited) CONDENSED CONSOLIDAT ED BALANCE SHEETS (In thousands, except share and per share data) September 30, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 133,019 $ 295,394 Short-term investments 256,588 275,304 Short-term deposits 16,788 6,885 Other receivable 3,507 — Prepaid expenses and other current assets 4,907 3,293 Total current assets 414,809 580,876 Long-term investments 10,029 29,829 Property and equipment, net — 8 Right-of-use asset, net 756 1,487 Restricted cash 217 217 Other assets — 463 Total assets $ 425,811 $ 612,880 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 4,898 $ 9,961 Collaboration payable, net 5,506 7,232 Accrued expenses and other current liabilities 48,121 39,856 Current portion of right-of-use liability 842 1,035 Current portion of capital lease 10 12 Total current liabilities 59,377 58,096 Long-term liabilities: Right-of-use liability, less current portion — 578 Capital lease, less current portion 2 10 Total long-term liabilities 2 588 Total liabilities 59,379 58,684 Commitments and contingencies (Note 12) Stockholders' equity: Preferred stock, $ 0.001 par value, 10,000,000 shares authorized; 0 shares outstanding at September 30, 2024 and December 31, 2023 — — Common stock, $ 0.0001 par value, 200,000,000 shares authorized; 85,571,205 and 84,826,632 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 9 8 Additional paid-in capital 1,493,041 1,456,370 Accumulated other comprehensive gain 371 218 Accumulated deficit ( 1,126,989 ) ( 902,400 ) Total stockholders' equity 366,432 554,196 Total liabilities and stockholders' equity $ 425,811 $ 612,880 The accompanying not

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View this 10-Q filing on SEC EDGAR