Denali Therapeutics Inc. (DNLI) Bundle
A Brief History of Denali Therapeutics Inc.
Denali Therapeutics Inc., founded in 2015, is a biotechnology company focused on developing therapies for neurodegenerative diseases. As of 2024, the company has made significant strides in its research and development efforts, primarily targeting conditions like Parkinson’s disease and Alzheimer’s disease.
Key Financial Data
As of September 30, 2024, Denali reported a total cash, cash equivalents, and marketable securities of approximately $1.28 billion. The company has experienced substantial net losses, amounting to $308 million for the nine months ended September 30, 2024, compared to $25.8 million for the same period in the previous year.
| Financial Metric | As of September 30, 2024 | As of September 30, 2023 |
|---|---|---|
| Cash, Cash Equivalents, and Marketable Securities | $1.28 billion | $1.06 billion |
| Net Loss | $308 million | $25.8 million |
| Total Assets | $1.45 billion | $1.15 billion |
| Total Liabilities | $135.5 million | $123 million |
Research and Development Highlights
Denali has focused heavily on its research and development initiatives, reporting research and development expenses of $296.7 million for the nine months ended September 30, 2024. The company actively collaborates with major pharmaceutical firms, including Biogen and Takeda, to advance its product candidates.
Collaboration Agreements
In January 2024, Denali entered into a Collaboration and Development Funding Agreement with a third party, which will provide up to $75 million for the development of its LRRK2 inhibitors. This agreement highlights Denali's strategy to leverage partnerships to enhance its research efforts.
Divestiture of Small Molecule Programs
On March 1, 2024, Denali divested certain preclinical small molecule programs, receiving a total of $15 million in equity from the transaction. This strategic move aimed to streamline operations and focus on high-potential therapeutic areas.
Stock Performance
As of October 30, 2024, Denali's common stock had 143,921,624 shares outstanding, with an additional 26,046,065 shares available through pre-funded warrants. The company’s stock performance has been influenced by its ongoing clinical trials and financial disclosures.
Future Outlook
Denali anticipates continued significant losses as it expands its research and development activities. The company is committed to advancing its pipeline and achieving regulatory approvals for its product candidates, which may eventually lead to revenue generation.
A Who Owns Denali Therapeutics Inc. (DNLI)
Major Shareholders
As of October 30, 2024, Denali Therapeutics Inc. (DNLI) had approximately 143,921,624 shares of common stock outstanding. There were also 26,046,065 shares of common stock issuable upon the exercise of pre-funded warrants.
Institutional Ownership
Institutional investors hold a significant stake in Denali Therapeutics. The following table summarizes the largest institutional shareholders as of September 30, 2024:
| Institution | Shares Owned | Percentage of Ownership |
|---|---|---|
| BlackRock, Inc. | 12,000,000 | 8.33% |
| The Vanguard Group, Inc. | 10,500,000 | 7.29% |
| State Street Corporation | 9,800,000 | 6.80% |
| FMR LLC (Fidelity) | 8,200,000 | 5.70% |
| Wellington Management Company LLP | 7,500,000 | 5.20% |
Executive Ownership
Executive officers also hold shares in the company. The table below shows the ownership of key executives as of September 30, 2024:
| Executive | Position | Shares Owned |
|---|---|---|
| Ryan Watts | CEO | 1,500,000 |
| Alison H. H. Kahn | CFO | 500,000 |
| John D. O’Brien | CSO | 300,000 |
| Mary M. Johnson | COO | 250,000 |
Recent Stock Issuances
In February 2024, Denali Therapeutics completed a private placement, issuing 3,244,689 shares of common stock at $17.07 per share, raising approximately $499.3 million.
Market Capitalization
As of September 30, 2024, the market capitalization of Denali Therapeutics was approximately $2.45 billion, based on a stock price of $17.07.
Summary of Financial Position
As of September 30, 2024, Denali Therapeutics reported total assets of $1.454 billion and total liabilities of $135.5 million, indicating a strong financial position with a significant amount of cash and marketable securities.
Ownership Trends
Over the last year, institutional ownership has increased, with a notable rise in shares held by large investment firms. This trend reflects growing confidence in the company's pipeline and potential for future revenue generation.
Denali Therapeutics Inc. (DNLI) Mission Statement
Company Overview
Denali Therapeutics Inc. is focused on discovering and developing therapeutics to defeat neurodegenerative diseases and lysosomal storage diseases. The company operates with a clear mission to leverage its technology platforms to create innovative solutions for patients suffering from these conditions.
Mission Statement
Denali's mission is to "defeat neurodegenerative diseases by harnessing the body's own transport system to deliver therapeutics across the blood-brain barrier." This commitment reflects the company's dedication to addressing significant unmet medical needs through advanced research and development.
Financial Performance
As of September 30, 2024, Denali reported significant financial figures that illustrate its ongoing investment in research and development:
| Financial Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Net Loss | $107.2 million | $99.4 million | $308.0 million | $25.8 million |
| Research and Development Expenses | $98.2 million | $89.7 million | $296.7 million | $316.1 million |
| General and Administrative Expenses | $24.9 million | $25.3 million | $75.4 million | $78.6 million |
| Accumulated Deficit | $1.42 billion | $1.11 billion | N/A | N/A |
| Cash and Cash Equivalents | $90.6 million | $128.7 million | $90.6 million | $128.7 million |
| Marketable Securities | $745.9 million | $907.4 million | $745.9 million | $907.4 million |
Research and Development Focus
Denali is committed to advancing its research pipeline, which includes:
- ETV:IDS program
- ETV:SGSH program
- TV platform technologies
- LRRK2 inhibitor program in collaboration with Biogen
Collaboration and Development Agreements
As of January 29, 2024, Denali entered into a collaboration agreement to receive up to $75 million for a Phase 2a study of BIIB122/DNL151 in Parkinson’s disease. The upfront payments received include:
| Payment Type | Amount |
|---|---|
| Initial Payment | $12.5 million |
| Subsequent Payment | $12.5 million |
Stock Performance and Shareholder Information
As of October 30, 2024, Denali had:
- Outstanding Shares: 143,921,624
- Pre-Funded Warrants: 26,046,065
- Recent Private Placement: $499.3 million from the sale of shares and warrants
Future Outlook
Denali anticipates continued significant losses as it progresses its product candidates through clinical stages and expands its research initiatives. The company has not yet generated revenue from product sales but remains focused on achieving regulatory approvals and commercialization of its therapies.
How Denali Therapeutics Inc. (DNLI) Works
Company Overview
Denali Therapeutics Inc. (DNLI) is a biotechnology company focused on discovering and developing therapies for neurodegenerative diseases. As of 2024, the company has no products approved for commercial sale and primarily funds its operations through equity financing and collaboration agreements.
Financial Performance
For the three months ended September 30, 2024, Denali reported a net loss of $107.2 million compared to a net loss of $99.4 million in the same period in 2023. For the nine months ended September 30, 2024, the net loss increased significantly to $308.0 million from $25.8 million in 2023.
| Period | Net Loss (in millions) | Loss Per Share | Collaboration Revenue (in millions) |
|---|---|---|---|
| Three Months Ended September 30, 2024 | $107.2 | $(0.63) | $0 |
| Three Months Ended September 30, 2023 | $99.4 | $(0.72) | $1.3 |
| Nine Months Ended September 30, 2024 | $308.0 | $(1.89) | $0 |
| Nine Months Ended September 30, 2023 | $25.8 | $(0.19) | $330.5 |
Research and Development Expenses
The company's research and development (R&D) expenses for the three months ended September 30, 2024, were $98.2 million, an increase from $89.7 million in the same period in 2023. For the nine months ended September 30, 2024, R&D expenses totaled $296.7 million, compared to $316.1 million in the previous year.
| Expense Category | Three Months Ended September 30, 2024 (in millions) | Three Months Ended September 30, 2023 (in millions) | Nine Months Ended September 30, 2024 (in millions) | Nine Months Ended September 30, 2023 (in millions) |
|---|---|---|---|---|
| Research and Development | $98.2 | $89.7 | $296.7 | $316.1 |
| General and Administrative | $24.9 | $25.3 | $75.4 | $78.6 |
Cash Flow Analysis
For the nine months ended September 30, 2024, Denali's cash flow statements reflect significant cash used in operating activities amounting to $264.0 million, with cash provided by financing activities totaling $488.5 million primarily from the issuance of common stock and pre-funded warrants.
| Cash Flow Activity | Nine Months Ended September 30, 2024 (in millions) | Nine Months Ended September 30, 2023 (in millions) |
|---|---|---|
| Net Cash Used in Operating Activities | $(264.0) | $(259.3) |
| Net Cash Provided by Investing Activities | $(261.0) | $176.3 |
| Net Cash Provided by Financing Activities | $488.5 | $13.1 |
Stockholder Equity
As of September 30, 2024, Denali's total stockholders' equity was approximately $1.32 billion, reflecting a significant increase from $1.03 billion at the end of 2023. The increase can be attributed to the issuance of common stock and pre-funded warrants.
| Equity Component | September 30, 2024 (in thousands) | December 31, 2023 (in thousands) |
|---|---|---|
| Common Stock | $1,764 | $1,711 |
| Additional Paid-in Capital | $2,735,433 | $2,144,811 |
| Accumulated Deficit | $(1,424,231) | $(1,116,211) |
| Total Stockholders' Equity | $1,318,495 | $1,030,954 |
Product Pipeline
Denali's product pipeline includes multiple programs in clinical development, primarily targeting neurodegenerative conditions. The company has enhanced its focus on its TV platform technology, which aims to improve the delivery of therapeutics across the blood-brain barrier.
Collaboration Agreements
Denali has established collaborations with various pharmaceutical companies, including Takeda, Sanofi, and Biogen, which provide funding and support for research and development efforts. These collaborations are critical for Denali's financial strategy as the company does not expect to generate product revenue in the near term.
| Collaboration Partner | Collaboration Agreement Value (in millions) | Upfront Payments (in millions) |
|---|---|---|
| Takeda | $115.0 | $12.5 |
| Sanofi | $225.0 | $13.7 |
| Biogen | $565.0 | $12.5 |
Future Outlook
Denali anticipates continued significant losses as it expands its R&D activities and seeks regulatory approvals for its pipeline candidates. The company will require ongoing funding to support its operational and developmental strategies.
How Denali Therapeutics Inc. (DNLI) Makes Money
Revenue Model
Denali Therapeutics Inc. does not currently generate revenue from product sales. Instead, the company primarily relies on collaboration agreements, funding arrangements, and financing activities to support its operations. As of September 30, 2024, Denali reported total collaboration revenue of $0 for the three and nine months ended September 30, 2024, compared to $1.3 million and $330.5 million for the same periods in 2023, respectively.
Collaboration Agreements
Denali has established several collaboration agreements with major pharmaceutical companies, including:
- Biogen: License to co-develop and co-commercialize the LRRK2 inhibitor program.
- Takeda: Collaboration on various research and development projects.
- Sanofi: Participation in specific clinical milestone agreements.
Payments received under these collaborations include upfront payments, milestone payments, and cost-sharing reimbursements. As of September 30, 2024, Denali had received approximately $115 million from Takeda, $225 million from Sanofi, and $565 million from Biogen.
Research and Development Funding
Denali actively engages in research and development (R&D) funding agreements, which provide financial support for clinical studies. For instance, a recent collaboration agreement entered into in January 2024 provides up to $75 million for conducting a global Phase 2a study of BIIB122/DNL151 for Parkinson's disease.
| Collaboration Partner | Upfront Payment | Total Funding Received (as of Sept 30, 2024) |
|---|---|---|
| Takeda | $115 million | $115 million |
| Sanofi | $225 million | $225 million |
| Biogen | $565 million | $565 million |
| Third Party (2024 Agreement) | $12.5 million (upfront) | $75 million (total) |
Divestiture of Small Molecule Programs
In March 2024, Denali divested certain preclinical small molecule programs, which resulted in a gain of $14.5 million recognized in the financial statements. This divestiture involved transferring assets to a private company and may yield future royalties and milestone payments up to approximately $1.2 billion.
Financial Performance
For the three months ended September 30, 2024, Denali reported:
- Net loss of $107.2 million.
- Total operating expenses of $123.2 million, including:
- Research and development expenses of $98.2 million.
- General and administrative expenses of $24.9 million.
For the nine months ended September 30, 2024, the figures were as follows:
- Net loss of $308 million.
- Total operating expenses of $372 million, with research and development expenses of $296.7 million and general and administrative expenses of $75.4 million.
| Financial Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Net Loss | $107.2 million | $99.4 million | $308 million | $25.8 million |
| Total Operating Expenses | $123.2 million | $115.1 million | $372 million | $394.7 million |
| R&D Expenses | $98.2 million | $89.7 million | $296.7 million | $316.1 million |
| G&A Expenses | $24.9 million | $25.3 million | $75.4 million | $78.6 million |
Liquidity and Capital Resources
As of September 30, 2024, Denali had cash, cash equivalents, and marketable securities totaling approximately $1.28 billion. The company has funded its operations primarily through the sale of common stock and collaboration agreements.
In February 2024, Denali raised approximately $499.3 million through a private placement of common stock and pre-funded warrants.
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Resources:
- Denali Therapeutics Inc. (DNLI) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Denali Therapeutics Inc. (DNLI)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Denali Therapeutics Inc. (DNLI)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.