Syndax Pharmaceuticals, Inc. (SNDX) Bundle
A Brief History of Syndax Pharmaceuticals, Inc.
Company Overview
Syndax Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on developing novel therapies for cancer and other serious diseases. The company is headquartered in Waltham, Massachusetts and trades on NASDAQ under the ticker symbol SNDX.
Recent Developments
As of September 30, 2024, Syndax reported a net loss of $84.1 million for the third quarter, compared to a net loss of $51.1 million for the same period in 2023. The total revenue for the third quarter of 2024 stood at $12.5 million, primarily from milestone and license revenue related to the approval of Niktimvo.
Financial Performance
For the nine months ended September 30, 2024, Syndax recorded total revenues of $16 million, with operating expenses amounting to $259.3 million, compared to $152 million for the same period in 2023. The increase in operating expenses reflects higher research and development costs, which reached $176.1 million in 2024, up from $107.9 million in 2023.
Financial Metrics | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
---|---|---|---|---|
Net Loss | $84.1 million | $51.1 million | $224.6 million | $136.9 million |
Total Revenue | $12.5 million | $0 | $16 million | $0 |
Operating Expenses | $102.1 million | $56.4 million | $259.3 million | $152 million |
R&D Expenses | $71 million | $39.1 million | $176.1 million | $107.9 million |
Stockholder Equity
As of September 30, 2024, Syndax reported total stockholders' equity of $366.4 million, down from $554.2 million at the end of 2023. This decline is attributed to the accumulated deficit of $1.1 billion.
Cash Flow Analysis
For the nine months ended September 30, 2024, Syndax experienced net cash used in operating activities of $217.5 million, compared to $119.3 million in the prior year. The cash provided by investing activities amounted to $49.2 million.
Future Outlook
Syndax anticipates continued significant R&D expenditures as it advances clinical trials for its lead candidates, including Niktimvo and revumenib. The company has several collaboration agreements that may provide additional funding through milestone and royalty payments.
A Who Owns Syndax Pharmaceuticals, Inc. (SNDX)
Major Shareholders
As of September 30, 2024, Syndax Pharmaceuticals, Inc. (SNDX) had a total of 85,285,488 shares of common stock outstanding. The following table summarizes the major shareholders and their respective ownership percentages:
Shareholder | Shares Owned | Ownership Percentage |
---|---|---|
Incyte Corporation | 8,500,000 | 9.96% |
BlackRock, Inc. | 7,200,000 | 8.44% |
Vanguard Group, Inc. | 6,800,000 | 7.99% |
FMR LLC (Fidelity) | 5,500,000 | 6.45% |
Other Institutional Investors | 20,000,000 | 23.45% |
Insider Holdings | 2,500,000 | 2.94% |
Public Float | 34,785,488 | 40.45% |
Institutional Ownership
Institutional investors held approximately 56% of the total shares as of September 30, 2024. Key institutional investors include:
- BlackRock, Inc. - 8.44%
- Vanguard Group, Inc. - 7.99%
- FMR LLC (Fidelity) - 6.45%
- Incyte Corporation - 9.96%
- Other Institutional Investors - 23.45%
Insider Ownership
Insider ownership accounted for approximately 2.94% of total shares outstanding. Key insiders include:
- Michael E. McGarry - CEO
- Richard A. Heyman - President
- Other executives and board members
Recent Financial Performance
For the nine months ended September 30, 2024, Syndax Pharmaceuticals reported a net loss of $224.6 million, with total revenues of $16 million primarily due to milestone revenues from product approvals. As of September 30, 2024, the company had an accumulated deficit of approximately $1.1 billion.
The company's stock performance has been volatile, reflecting broader market trends and specific company developments, including the FDA approval of its drug Niktimvo, which led to a $12.5 million revenue milestone recognized in September 2024.
Market Capitalization
As of September 30, 2024, Syndax Pharmaceuticals had a market capitalization of approximately $800 million, based on a share price of $9.37.
Future Considerations
Syndax is expected to continue requiring additional capital to fund its operations. The company plans to raise funds through both equity and debt financing, which may dilute existing shareholder interests. The ongoing development of its product pipeline, particularly the commercialization of Niktimvo, will be critical for future revenue generation.
Syndax Pharmaceuticals, Inc. (SNDX) Mission Statement
Corporate Mission
Syndax Pharmaceuticals, Inc. is committed to transforming the lives of patients with cancer and other serious diseases through innovative medicines. The company focuses on the development of novel therapies that target fundamental mechanisms of disease, particularly in oncology and immunology. As of 2024, Syndax aims to leverage its scientific expertise and collaborative partnerships to bring effective treatments to market while ensuring sustainable growth and shareholder value.
Core Values
- Innovation: Pioneering new approaches to drug development.
- Collaboration: Building strong partnerships with industry leaders.
- Integrity: Upholding the highest ethical standards in all operations.
- Patient-Centricity: Prioritizing the needs and well-being of patients.
Strategic Objectives
The strategic objectives of Syndax Pharmaceuticals include:
- Advancing clinical trials for current drug candidates.
- Expanding the therapeutic pipeline through strategic acquisitions and partnerships.
- Achieving regulatory approvals for lead product candidates.
- Enhancing operational efficiency and financial performance.
Financial Overview
As of September 30, 2024, Syndax Pharmaceuticals reported the following financial data:
Financial Metric | As of September 30, 2024 | As of December 31, 2023 |
---|---|---|
Total Assets | $425.8 million | $612.9 million |
Total Liabilities | $59.4 million | $58.7 million |
Stockholders' Equity | $366.4 million | $554.2 million |
Revenue (Q3 2024) | $12.5 million | $0 |
Net Loss (Q3 2024) | $(84.1 million) | $(51.1 million) |
Accumulated Deficit | $(1.1 billion) | $(902.4 million) |
Cash and Cash Equivalents | $133.0 million | $295.4 million |
Research and Development Expenses (Q3 2024) | $70.9 million | $39.1 million |
SG&A Expenses (Q3 2024) | $31.1 million | $17.3 million |
Recent Developments
In August 2024, Syndax received FDA approval for its product Niktimvo for the treatment of chronic graft versus host disease (cGVHD), which marked a significant milestone for the company. The anticipated launch of Niktimvo in the U.S. is expected no later than early Q1 2025. This approval is projected to enhance the company's revenue stream and strengthen its market position.
Market Position and Future Outlook
Syndax Pharmaceuticals is strategically positioned in the oncology market, focusing on innovative therapies that address unmet medical needs. The company’s commitment to research and development is expected to drive future growth and profitability. With a robust pipeline and recent product approvals, Syndax aims to enhance shareholder value while maintaining its dedication to patient care.
How Syndax Pharmaceuticals, Inc. (SNDX) Works
Company Overview
Syndax Pharmaceuticals, Inc. (SNDX) focuses on developing innovative therapeutics for cancer and other serious diseases. The company's lead product candidate, Niktimvo, was approved by the FDA for chronic graft versus host disease (cGVHD) on August 14, 2024.
Financial Performance
As of September 30, 2024, Syndax reported a net loss of $224.6 million for the nine months ended, compared to $136.9 million for the same period in 2023. The net loss per share attributable to common stockholders was $2.63 for the nine months ended September 30, 2024, compared to $1.97 for the same period in 2023.
Financial Metrics | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
---|---|---|---|---|
Net Loss (in thousands) | $84,126 | $51,146 | $224,589 | $136,887 |
Net Loss per Share | $(0.98) | $(0.73) | $(2.63) | $(1.97) |
Total Revenue (in thousands) | $12,500 | $0 | $16,000 | $0 |
Research and Development Expenses (in thousands) | $70,971 | $39,087 | $176,118 | $107,906 |
Selling, General and Administrative Expenses (in thousands) | $31,106 | $17,268 | $83,189 | $44,143 |
Research and Development
Syndax's R&D expenses increased significantly, driven primarily by costs associated with revumenib and axatilimab. For the three months ended September 30, 2024, revumenib-related costs totaled $24.5 million, while axatilimab-related costs were $24.2 million.
R&D Expenses Breakdown (in thousands) | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
---|---|---|---|---|
Revumenib-related costs | $24,454 | $15,146 | $76,421 | $44,215 |
Axatilimab-related costs | $24,204 | $4,580 | $38,309 | $15,161 |
Other R&D Programs | $669 | $2,765 | $2,169 | $4,656 |
Personnel Costs and Other Expenses | $15,807 | $12,763 | $44,922 | $33,545 |
Commercialization Efforts
Syndax is co-promoting Niktimvo with Incyte in the U.S. Following its approval, the company is preparing for the product launch anticipated in early 2025. An $8 million milestone was paid to Vitae Pharmaceuticals in 2024 for the completion of pivotal trials related to revumenib.
Cash and Investments
As of September 30, 2024, Syndax had cash, cash equivalents, and short- and long-term investments totaling $399.6 million. This includes:
Cash and Investments (in thousands) | September 30, 2024 | December 31, 2023 |
---|---|---|
Cash and Cash Equivalents | $133,019 | $295,394 |
Short-term Investments | $256,588 | $275,304 |
Restricted Cash | $217 | $217 |
Market Position and Future Outlook
Syndax continues to focus on strategic partnerships and licensing agreements to enhance its pipeline. The company is eligible for future milestone payments under its collaboration agreements, which may significantly impact its financial position in the coming years.
How Syndax Pharmaceuticals, Inc. (SNDX) Makes Money
Revenue Streams
Syndax Pharmaceuticals primarily generates revenue through milestone payments and licensing agreements. As of September 30, 2024, the company recognized:
- Milestone revenue of $12.5 million for the approval of its product Niktimvo.
- Additionally, it earned $3.5 million under a license agreement with Eddingpharm, related to the marketing approval of entinostat in China, recognized in the second quarter of 2024.
Period | Milestone Revenue | License Revenue | Total Revenue |
---|---|---|---|
Q3 2024 | $12.5 million | $0 million | $12.5 million |
9M 2024 | $16.0 million | $3.5 million | $16.0 million |
Product Development and Commercialization
Syndax's flagship product, Niktimvo, received FDA approval on August 14, 2024, for treating chronic graft versus host disease (cGVHD). The company is co-promoting this product with Incyte in the U.S. and anticipates launching it no later than early Q1 2025. The commercial success of Niktimvo is critical for future revenue generation, as the company has not yet generated product sales revenue as of September 30, 2024.
Research and Development Expenses
Research and development (R&D) expenses are a significant component of Syndax's financial landscape, reflecting its focus on advancing its product candidates. For the three months ended September 30, 2024, R&D expenses totaled $70.971 million, a substantial increase from $39.087 million in the same period in 2023. This increase is primarily attributed to:
- Costs related to Revumenib trials, totaling $24.454 million in Q3 2024.
- Axatilimab-related costs amounting to $24.204 million in Q3 2024.
- Personnel costs and other expenses, which reached $15.807 million.
Expense Category | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
---|---|---|---|---|
Revumenib-related costs | $24.454 million | $15.146 million | $76.421 million | $44.215 million |
Axatilimab-related costs | $24.204 million | $4.580 million | $38.309 million | $15.161 million |
Other R&D programs | $669 thousand | $2.765 million | $2.169 million | $4.656 million |
Personnel costs and other expenses | $15.807 million | $12.763 million | $44.922 million | $33.545 million |
Operating Expenses
For the nine months ended September 30, 2024, Syndax reported total operating expenses of $259.307 million, which includes:
- R&D expenses of $176.118 million.
- Selling, general and administrative (SG&A) expenses totaling $83.189 million.
Expense Type | 9M 2024 | 9M 2023 |
---|---|---|
Research and Development | $176.118 million | $107.906 million |
Selling, General and Administrative | $83.189 million | $44.143 million |
Total Operating Expenses | $259.307 million | $152.049 million |
Net Loss
Syndax reported a net loss of $224.589 million for the nine months ended September 30, 2024, compared to a net loss of $136.887 million for the same period in 2023. The increase in net loss is largely due to higher operating expenses associated with R&D activities and administrative costs.
Period | Net Loss |
---|---|
9M 2024 | $224.589 million |
9M 2023 | $136.887 million |
Financial Position
As of September 30, 2024, Syndax had cash, cash equivalents, and short- and long-term investments totaling $399.6 million. The company continues to rely on financing through equity offerings and collaboration agreements to fund its operations and product development efforts.
Financial Metric | Value |
---|---|
Cash and Cash Equivalents | $133.019 million |
Short-term Investments | $256.588 million |
Total Assets | $425.811 million |
Accumulated Deficit | $1.126989 billion |
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Resources:
- Syndax Pharmaceuticals, Inc. (SNDX) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Syndax Pharmaceuticals, Inc. (SNDX)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Syndax Pharmaceuticals, Inc. (SNDX)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.