Edgewise Therapeutics, Inc. (EWTX) Bundle
A Brief History of Edgewise Therapeutics, Inc.
Edgewise Therapeutics, Inc. has been actively engaged in the development of innovative therapies for the treatment of muscle disorders. As of 2024, the company continues to navigate a challenging but promising landscape in biotechnology.
Founding and Early Development
Founded in 2017, Edgewise Therapeutics initially focused on developing treatments based on its proprietary technology platform aimed at addressing muscle-related ailments. The company has since made significant strides in clinical development, particularly with its lead product candidates, sevasemten and EDG-7500.
Clinical Trials and Product Development
As of September 30, 2024, Edgewise has engaged in various clinical trials, including:
- GRAND CANYON trial for sevasemten
- FOX trial for sevasemten
- LYNX trial for sevasemten
- MESA trial for sevasemten
- CIRRUS-HCM trial for EDG-7500
These trials are integral to the company's strategy to advance its product candidates through preclinical and clinical stages.
Financial Performance
Edgewise Therapeutics has reported significant financial metrics that reflect its operational status:
| Metric | 2024 (9 months ending September 30) | 2023 (9 months ending September 30) | Change |
|---|---|---|---|
| Research and Development Expenses | $90.6 million | $63.2 million | $27.4 million |
| General and Administrative Expenses | $22.7 million | $17.3 million | $5.4 million |
| Net Loss | $94.2 million | $70.0 million | $24.2 million |
| Interest Income | $19.1 million | $10.5 million | $8.7 million |
As of September 30, 2024, the company reported an accumulated deficit of $338.9 million, reflecting its ongoing investment in R&D and operational expenditures.
Funding and Liquidity
Edgewise has financed its operations primarily through the issuance of common stock and private placements. As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $492.5 million, which is expected to support its operations for at least the next 12 months.
Future Prospects
Looking ahead, Edgewise Therapeutics aims to advance its clinical programs and seek regulatory approvals for its product candidates. The company expects to continue incurring significant losses as it invests in its pipeline and expands its operational capacity.
A Who Owns Edgewise Therapeutics, Inc. (EWTX)
Ownership Structure
As of 2024, Edgewise Therapeutics, Inc. (EWTX) has a diverse ownership structure consisting of institutional investors, individual shareholders, and company executives. The total number of shares outstanding as of September 30, 2024, is 94,408,911 shares.
Major Shareholders
The following table outlines the major shareholders of Edgewise Therapeutics, including their ownership percentages and the number of shares held:
| Shareholder | Shares Held | Ownership Percentage |
|---|---|---|
| BlackRock, Inc. | 9,300,000 | 9.8% |
| Vanguard Group, Inc. | 7,800,000 | 8.3% |
| FMR LLC (Fidelity) | 6,500,000 | 6.9% |
| State Street Corporation | 4,500,000 | 4.8% |
| Company Executives and Directors | 2,500,000 | 2.6% |
Institutional Ownership
Institutional investors play a significant role in Edgewise Therapeutics' ownership. The latest data shows that approximately 70% of the company's shares are held by institutional investors. This includes major investment firms and mutual funds that contribute to the company’s capital structure.
Executive Ownership
Executive officers and directors of Edgewise Therapeutics have a vested interest in the company, holding a cumulative total of about 2.6% of the outstanding shares. This ownership aligns their interests with those of shareholders.
Recent Stock Offerings
In January 2024, Edgewise Therapeutics completed an underwritten registered direct offering of 21,818,182 shares at a price of $11.00 per share, raising gross proceeds of $240 million. This significant capital influx is expected to support ongoing clinical trials and operational expenses.
Market Capitalization
As of September 30, 2024, Edgewise Therapeutics had a market capitalization of approximately $1.04 billion, based on the share price and total shares outstanding.
Recent Financial Performance
For the nine months ending September 30, 2024, Edgewise reported a net loss of $94.2 million, reflecting ongoing investments in research and development. The company's financial position remains robust with cash and cash equivalents amounting to $492.5 million.
Conclusion on Ownership Trends
Overall, Edgewise Therapeutics demonstrates a strong institutional backing, with major shareholders holding significant stakes. The company’s ownership composition is indicative of confidence in its growth potential within the biopharmaceutical sector, particularly as it advances its clinical programs targeting severe muscle diseases.
Edgewise Therapeutics, Inc. (EWTX) Mission Statement
Company Overview
Edgewise Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for severe muscle diseases. The company utilizes its expertise in muscle physiology and small molecule drug discovery to create first-in-class therapeutics aimed at addressing significant unmet medical needs.
Mission Statement
As of 2024, Edgewise Therapeutics is committed to advancing the next generation of therapeutics that target muscle biology. The company's mission emphasizes the importance of improving the lives of patients suffering from muscle disorders through innovative drug development.
Financial Overview
Edgewise Therapeutics has experienced significant financial activities leading up to 2024, including various capital-raising efforts and investments in research and development.
| Financial Metrics | 2024 (Q3) | 2023 (Q3) | Change |
|---|---|---|---|
| Net Loss | $94.2 million | $70.0 million | $24.2 million |
| Operating Expenses | $113.3 million | $80.5 million | $32.8 million |
| Research and Development Expenses | $90.6 million | $63.2 million | $27.4 million |
| General and Administrative Expenses | $22.7 million | $17.3 million | $5.4 million |
| Interest Income | $19.1 million | $10.5 million | $8.6 million |
Capital Structure
As of September 30, 2024, Edgewise Therapeutics reported total stockholders' equity of $488.9 million, reflecting strong capital support for ongoing operations and product development.
| Capital Metrics | As of September 30, 2024 | As of December 31, 2023 |
|---|---|---|
| Total Assets | $511.3 million | $340.0 million |
| Cash and Cash Equivalents | $44.8 million | $86.1 million |
| Marketable Securities | $447.7 million | $232.3 million |
| Accumulated Deficit | $(338.9 million) | $(244.8 million) |
Research and Development Focus
Edgewise Therapeutics is advancing two key product candidates:
- Sevasemten (EDG-5506): An orally administered skeletal myosin inhibitor in pivotal trials for Becker muscular dystrophy and ongoing Phase 2 programs in Duchenne muscular dystrophy.
- EDG-7500: A novel cardiac sarcomere modulator targeting hypertrophic cardiomyopathy (HCM), currently in Phase 2 trials.
Funding and Future Outlook
To support its research and clinical development, Edgewise has engaged in various funding strategies, including:
- Underwritten registered direct offering generating $240 million in gross proceeds as of January 2024.
- At-the-market (ATM) offering program expected to raise up to $175 million, initiated in May 2024.
The company anticipates high research and development expenditures as it continues to advance its product candidates through clinical trials and seeks regulatory approval.
How Edgewise Therapeutics, Inc. (EWTX) Works
Company Overview
Edgewise Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for severe muscle diseases. As of 2024, the company is advancing two primary clinical-stage programs: Sevasemten (EDG-5506) for Becker muscular dystrophy and EDG-7500 for hypertrophic cardiomyopathy (HCM).
Financial Performance
For the nine months ended September 30, 2024, Edgewise reported a net loss of $94.2 million, compared to a net loss of $70.0 million for the same period in 2023. The increase in net loss was primarily driven by higher research and development expenses.
| Financial Metrics | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Net Loss | $94,151,000 | $70,020,000 |
| Research and Development Expenses | $90,596,000 | $63,221,000 |
| General and Administrative Expenses | $22,696,000 | $17,274,000 |
| Total Operating Expenses | $113,292,000 | $80,495,000 |
| Interest Income | $19,141,000 | $10,475,000 |
Research and Development Expenses
Research and development (R&D) expenses for the nine months ended September 30, 2024, totaled $90.6 million, reflecting an increase of $27.4 million from the prior year. This increase was largely due to the ongoing clinical trials for Sevasemten and EDG-7500.
| R&D Expenses Breakdown | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Sevasemten Clinical Program | $37,886,000 | $23,231,000 |
| EDG-7500 Clinical Program | $13,208,000 | $3,979,000 |
| Discovery and Preclinical | $7,120,000 | $11,885,000 |
| Internal Costs | $32,382,000 | $24,126,000 |
Cash Flow Analysis
Cash flows for the nine months ended September 30, 2024, indicated a net cash used in operating activities of $82.1 million, up from $65.1 million in 2023. The primary driver of cash usage was the company's operational expenditures.
| Cash Flow Summary | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Net Cash Used in Operating Activities | $(82,071,000) | $(65,118,000) |
| Net Cash Provided by Investing Activities | $(205,578,000) | $75,903,000 |
| Net Cash Provided by Financing Activities | $246,358,000 | $179,000 |
| Net (Decrease) Increase in Cash | $(41,291,000) | $10,964,000 |
Liquidity and Capital Resources
As of September 30, 2024, Edgewise had cash, cash equivalents, and marketable securities totaling $492.5 million. This capital is expected to fund operations and development activities over the next 12 months.
Stockholder Equity
As of September 30, 2024, Edgewise had total stockholders' equity of $488.9 million, up from $318.8 million at the end of 2023. The increase was primarily due to equity financing activities.
| Stockholder Equity Summary | As of September 30, 2024 | As of December 31, 2023 |
|---|---|---|
| Common Stock Issued | 94,408,911 shares | 70,453,342 shares |
| Additional Paid-In Capital | $826,731,000 | $563,487,000 |
| Accumulated Deficit | $(338,914,000) | $(244,763,000) |
| Total Stockholders' Equity | $488,877,000 | $318,830,000 |
Operational Activities
Edgewise Therapeutics continues to invest heavily in R&D to advance its drug candidates through clinical trials. The company is also focusing on expanding its operational capabilities, which includes hiring additional personnel to support its growing research and development initiatives.
How Edgewise Therapeutics, Inc. (EWTX) Makes Money
Revenue Model
Edgewise Therapeutics, Inc. (EWTX) has not generated any revenue as of September 30, 2024. The company is primarily focused on the research and development of innovative treatments for severe muscle diseases, including Becker muscular dystrophy and hypertrophic cardiomyopathy. Their revenue generation is contingent upon the successful development and commercialization of their product candidates, namely sevasemten (EDG-5506) and EDG-7500.
Financial Performance
As of September 30, 2024, Edgewise reported a net loss of $94.2 million, compared to a loss of $70.0 million for the same period in 2023. The increase in losses is attributed to heightened research and development expenditures as the company advances its clinical trials.
Operating Expenses
The operating expenses for Edgewise Therapeutics for the nine months ended September 30, 2024, are detailed below:
| Expense Category | 2024 (in thousands) | 2023 (in thousands) | Change (in thousands) |
|---|---|---|---|
| Research and Development | $90,596 | $63,221 | $27,375 |
| General and Administrative | $22,696 | $17,274 | $5,422 |
| Total Operating Expenses | $113,292 | $80,495 | $32,797 |
Research and Development Expenses
The majority of the operating expenses are attributed to research and development, which includes costs related to clinical trials, external manufacturing, and personnel. The breakdown of research and development expenses for the nine months ended September 30, 2024, is as follows:
| R&D Expense Category | 2024 (in thousands) | 2023 (in thousands) | Change (in thousands) |
|---|---|---|---|
| Sevasemten Clinical Program | $37,886 | $23,231 | $14,655 |
| EDG-7500 Clinical Program | $13,208 | $3,979 | $9,229 |
| Discovery and Preclinical | $7,120 | $11,885 | ($4,765) |
| Internal Costs (Personnel Related) | $32,382 | $24,126 | $8,256 |
| Total R&D Expenses | $90,596 | $63,221 | $27,375 |
Interest Income
Interest income for Edgewise Therapeutics was $19.1 million for the nine months ended September 30, 2024, a significant increase from $10.5 million in the same period of 2023. This increase is primarily due to higher balances of marketable securities held by the company.
Capital Resources and Funding
As of September 30, 2024, Edgewise Therapeutics had cash, cash equivalents, and marketable securities totaling $492.5 million. The company has financed its operations through private placements and public offerings, generating net proceeds of $606.6 million since inception. Notably, in January 2024, the company raised $240.0 million from an underwritten registered direct offering.
Liquidity Outlook
Edgewise anticipates that its current cash resources will be sufficient to fund operations for at least the next 12 months. However, the company expects to require substantial additional capital to continue its research and development efforts, particularly to advance its product candidates through clinical trials and regulatory approvals.
Net Loss Summary
The net losses reported by Edgewise Therapeutics for the three and nine months ended September 30, 2024, compared to the same periods in 2023, are as follows:
| Period | Net Loss (in thousands) | 2024 | 2023 |
|---|---|---|---|
| Three Months | $34,129 | $25,713 | |
| Nine Months | $94,151 | $70,020 |
As a clinical-stage biopharmaceutical company, Edgewise's ability to make money hinges on the successful development and commercialization of its therapeutic products, which requires ongoing investment and capital management.
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Resources:
- Edgewise Therapeutics, Inc. (EWTX) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Edgewise Therapeutics, Inc. (EWTX)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Edgewise Therapeutics, Inc. (EWTX)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.