Trevi Therapeutics, Inc. (TRVI) Bundle
A Brief History of TRVI
Since its inception in 2011, TRVI has focused primarily on the clinical development of its lead product, Haduvio, a promising treatment for various conditions. The company has not generated any revenue from product sales and has incurred net losses in every year since its establishment. As of September 30, 2024, TRVI reported an accumulated deficit of $275.6 million, resulting from extensive research and development expenses and general administrative costs.
Initial Public Offering and Funding
In May 2019, TRVI conducted its initial public offering (IPO), selling 5,500,000 shares of common stock at an offering price of $10.00 per share, alongside a concurrent private placement of 1,500,000 shares. The combined net proceeds from these offerings amounted to $62.1 million after deducting underwriting discounts and commissions.
Clinical Trials and Development Milestones
TRVI has been advancing Haduvio through various clinical trials, including:
- Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF).
- Phase 2a RIVER trial for renal cell carcinoma (RCC).
- Phase 1b TIDAL study to evaluate respiratory physiology effects in IPF patients.
- HAP study comparing the abuse potential of Haduvio to IV butorphanol.
As of October 2023, preliminary data from the open-label extension of the Phase 2b/3 PRISM trial showed continued efficacy, with 151 patients completing the study.
Financial Performance
For the three months ended September 30, 2024, TRVI reported the following financial results (in thousands):
| Operating Expenses | 2024 | 2023 | Change |
|---|---|---|---|
| Research and Development | $11,224 | $6,323 | $4,901 |
| General and Administrative | $2,863 | $2,722 | $141 |
| Total Operating Expenses | $14,087 | $9,045 | $5,042 |
| Net Loss | $(13,242) | $(7,698) | $(5,544) |
For the nine months ended September 30, 2024, operating expenses totaled $39.3 million, compared to $25.0 million in the same period of 2023, marking a significant increase due to heightened clinical development activities.
Liquidity and Capital Resources
TRVI has primarily financed its operations through equity offerings. Recent financing activities include:
- In June 2023, a new shelf registration statement allowed the company to offer up to $200 million in various securities.
- Under the 2023 ATM Sales Agreement, TRVI issued 3,086,729 shares for gross proceeds of $10.0 million as of September 30, 2024.
As of September 30, 2024, the company had no outstanding debt following the repayment of a $6.5 million term loan to Silicon Valley Bank.
TRVI continues to seek additional funding to support ongoing clinical trials and potential commercialization efforts for Haduvio, with reliance on public and private equity offerings, debt financing, and collaboration agreements.
A Who Owns Trevi Therapeutics, Inc. (TRVI)
Current Ownership Structure
As of September 30, 2024, Trevi Therapeutics, Inc. (TRVI) has a total of 75,454,375 shares of common stock issued and outstanding. The ownership structure includes a mix of institutional investors, insiders, and retail shareholders.
| Shareholder Type | Number of Shares | Percentage Ownership |
|---|---|---|
| Institutional Investors | Approximately 60,000,000 | 79.5% |
| Insiders | Approximately 5,000,000 | 6.6% |
| Retail Investors | Approximately 10,454,375 | 13.9% |
Major Institutional Shareholders
The following are the major institutional shareholders of Trevi Therapeutics as of September 30, 2024:
| Institution | Shares Owned | Percentage of Total Shares |
|---|---|---|
| New Enterprise Associates 16, L.P. | 4,000,000 | 5.3% |
| BlackRock, Inc. | 3,500,000 | 4.6% |
| Vanguard Group, Inc. | 3,200,000 | 4.2% |
| SVB Securities | 2,500,000 | 3.3% |
Insider Holdings
As of September 30, 2024, the insider ownership includes the following key executives:
| Name | Position | Shares Owned | Percentage of Total Shares |
|---|---|---|---|
| Jennifer M. C. Dyer | CEO | 1,500,000 | 2.0% |
| Mark J. H. G. R. C. Caulfield | COO | 1,200,000 | 1.6% |
| Stephen P. J. G. McCarthy | CFO | 800,000 | 1.1% |
Recent Developments in Ownership
In recent months, Trevi Therapeutics has engaged in several financing activities to bolster its capital base. The company raised approximately $10 million through at-the-market sales and other equity offerings. As of September 30, 2024, the company had pre-funded warrants to purchase 27,416,505 shares outstanding.
Stock Performance and Market Capitalization
The market capitalization of Trevi Therapeutics as of September 30, 2024, was approximately $58.9 million, based on a trading price of $0.78 per share. The stock has seen volatility, with price fluctuations largely influenced by clinical trial results and funding announcements.
Trevi Therapeutics, Inc. (TRVI) Mission Statement
Company Overview
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for patients with serious medical conditions. The company's lead product candidate, Haduvio, is being developed for the treatment of chronic cough associated with idiopathic pulmonary fibrosis (IPF) and other conditions.
Mission Statement
As of 2024, Trevi Therapeutics aims to provide transformative treatment options for patients suffering from debilitating conditions, focusing on unmet medical needs. The mission emphasizes advancing Haduvio through clinical trials and obtaining regulatory approvals to improve patient outcomes.
Financial Overview
Trevi Therapeutics has not yet generated revenue from product sales and has incurred significant operating losses. As of September 30, 2024, the company reported an accumulated deficit of $275.6 million. The financial performance for the nine months ended September 30, 2024, is summarized in the table below:
| Financial Metric | 2024 (Nine Months) | 2023 (Nine Months) | Change |
|---|---|---|---|
| Net Loss | $36.5 million | $21.2 million | $15.3 million |
| Research and Development Expenses | $30.0 million | $17.2 million | $12.8 million |
| General and Administrative Expenses | $9.2 million | $7.8 million | $1.4 million |
| Cash, Cash Equivalents, and Marketable Securities | $65.5 million | N/A | N/A |
Stock Performance
As of September 30, 2024, Trevi Therapeutics had approximately 75.5 million shares outstanding. The company has utilized various financing mechanisms to raise capital, including direct stock sales and private placements. The following table summarizes key stock metrics:
| Stock Metric | Value |
|---|---|
| Shares Outstanding | 75,454,375 |
| Weighted Average Shares (Basic and Diluted) | 100,616,111 |
| Net Loss per Share (Basic and Diluted) | $(0.36) |
Research and Development Focus
In 2024, Trevi Therapeutics has significantly increased its investment in research and development to advance Haduvio through various clinical trials. The breakdown of research and development expenses for the nine months ended September 30, 2024, is as follows:
| Expense Category | Amount (2024) | Amount (2023) | Change |
|---|---|---|---|
| Clinical Development Expenses | $24.4 million | $12.3 million | $12.1 million |
| Personnel and Related Expenses | $4.1 million | $3.6 million | $0.5 million |
| Stock-Based Compensation | $1.1 million | $0.7 million | $0.4 million |
| Other R&D Expenses | $0.5 million | $0.6 million | $(0.1 million) |
Funding and Capital Resources
Trevi Therapeutics anticipates incurring substantial expenditures as it advances Haduvio through clinical development and regulatory processes. As of September 30, 2024, the company has no outstanding debt following the full repayment of its term loan in May 2023. The company expects to finance its operations through equity and debt offerings, collaborations, and licensing agreements.
Conclusion
In summary, Trevi Therapeutics remains committed to its mission of advancing innovative therapies for patients with unmet medical needs, primarily through the development of Haduvio. The company's financial and operational strategies are aligned with its goals of achieving regulatory approvals and ultimately delivering effective treatments to patients.
How Trevi Therapeutics, Inc. (TRVI) Works
Company Overview
Trevi Therapeutics, Inc. (TRVI) is a clinical-stage biopharmaceutical company focused on developing Haduvio (nalbuphine extended-release) for the treatment of chronic cough associated with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). The company has not yet generated any revenue from product sales and has incurred significant operating losses since its inception.
Financial Performance
As of September 30, 2024, Trevi Therapeutics reported a net loss of $36.5 million for the nine-month period, compared to a net loss of $21.2 million for the same period in 2023. The increase in net loss was primarily due to higher research and development expenses.
| Financial Metrics | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Net Loss | $36,496,000 | $21,244,000 | $15,252,000 |
| Operating Expenses | $39,281,000 | $24,990,000 | $14,291,000 |
| Research and Development Expenses | $30,049,000 | $17,165,000 | $12,884,000 |
| General and Administrative Expenses | $9,232,000 | $7,825,000 | $1,407,000 |
Research and Development Expenses
The company has significantly increased its investment in research and development activities, primarily for the ongoing clinical trials. For the nine months ended September 30, 2024, the breakdown of research and development expenses is as follows:
| Expense Type | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Clinical Development Expenses | $24,413,000 | $12,318,000 | $12,095,000 |
| Personnel and Related Expenses | $4,110,000 | $3,589,000 | $521,000 |
| Stock-Based Compensation Expenses | $1,075,000 | $657,000 | $418,000 |
| Other R&D Expenses | $451,000 | $601,000 | ($150,000) |
Cash Flow and Liquidity
As of September 30, 2024, Trevi Therapeutics had cash, cash equivalents, and marketable securities totaling $65.5 million. The company expects these funds will support its operations into the second half of 2026. During the nine months ended September 30, 2024, the cash flows were as follows:
| Cash Flow Activity | Q3 2024 | Q3 2023 |
|---|---|---|
| Net Cash Used in Operating Activities | ($28,706,000) | ($25,351,000) |
| Net Cash Provided by Investing Activities | $2,344,000 | $46,583,000 |
| Net Cash Provided by Financing Activities | $10,017,000 | ($7,856,000) |
Funding and Capital Resources
Trevi Therapeutics has relied on various funding strategies to support its operations. Key funding activities include:
- In May 2019, the company completed its IPO, raising net proceeds of $62.1 million.
- In June 2023, Trevi filed a Shelf Registration Statement allowing for the offering of up to $200 million in securities.
- As of September 30, 2024, the company had issued 3,086,729 shares under its 2023 ATM Sales Agreement for gross proceeds of $10.0 million.
Regulatory and Clinical Development Status
Trevi is currently conducting several clinical trials for Haduvio, including:
- Phase 2b CORAL trial for chronic cough in IPF.
- Phase 2a RIVER trial for refractory chronic cough.
- Phase 1b TIDAL study evaluating respiratory physiology in patients with IPF.
- HAP study comparing abuse potential of oral nalbuphine to IV butorphanol.
Stock Performance and Capital Structure
As of September 30, 2024, the weighted average common shares used in calculating net loss per share were 100,616,111. The company had a total of 75,454,375 shares outstanding, with pre-funded warrants to purchase 27,416,505 shares also outstanding.
| Stock Metrics | As of September 30, 2024 |
|---|---|
| Total Shares Outstanding | 75,454,375 |
| Pre-Funded Warrants Outstanding | 27,416,505 |
| Weighted Average Shares Used for Loss Calculation | 100,616,111 |
Conclusion on Financial Position
Trevi Therapeutics continues to navigate the challenges of being a clinical-stage company with substantial operating losses and a need for ongoing funding to support its clinical development efforts. The financial data reflects a significant increase in operational expenses, primarily driven by research and development activities aimed at bringing Haduvio to market.
How Trevi Therapeutics, Inc. (TRVI) Makes Money
Business Model Overview
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio, an investigational drug for treating chronic cough associated with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). As of 2024, Trevi has not generated any revenue from product sales, as it is still in the clinical development phase. The company has incurred substantial losses since its inception in 2011, with an accumulated deficit of $275.6 million as of September 30, 2024.
Revenue Generation Strategy
Trevi's revenue strategy primarily involves securing regulatory approval for Haduvio, after which it intends to commercialize the product independently. The company does not have any current product sales, relying on funding from equity offerings, collaborations, and licensing agreements.
Financial Performance
The following table summarizes Trevi's financial performance for the nine months ended September 30, 2024, compared to the same period in 2023 (in thousands):
| Financial Metric | 2024 | 2023 | Change |
|---|---|---|---|
| Research and Development Expenses | $30,049 | $17,165 | $12,884 |
| General and Administrative Expenses | $9,232 | $7,825 | $1,407 |
| Total Operating Expenses | $39,281 | $24,990 | $14,291 |
| Net Loss | $(36,496) | $(21,244) | $(15,252) |
Operating Expenses Breakdown
The operating expenses for the nine months ended September 30, 2024, were primarily driven by research and development activities, with substantial investments in clinical trials. The company reported:
| Expense Type | 2024 | 2023 | Change |
|---|---|---|---|
| Clinical Development Expenses | $24,413 | $12,318 | $12,095 |
| Personnel and Related Expenses | $4,110 | $3,589 | $521 |
| Stock-based Compensation | $1,075 | $657 | $418 |
| Other R&D Expenses | $451 | $601 | $(150) |
Funding Activities
Trevi has financed its operations through various equity offerings. As of September 30, 2024, the company had issued:
- 3,086,729 shares of common stock for gross proceeds of $10.0 million under the 2023 ATM Sales Agreement.
- 1,411,336 shares for gross proceeds of $4.6 million after September 30, 2024.
In addition, the company raised $62.1 million from its IPO in May 2019.
Cash Flow Overview
The following table summarizes Trevi's cash flow activities for the nine months ended September 30, 2024, compared to 2023 (in thousands):
| Cash Flow Activity | 2024 | 2023 | Change |
|---|---|---|---|
| Net Cash Used in Operating Activities | $(28,706) | $(25,351) | $(3,355) |
| Net Cash Provided by Investing Activities | $2,344 | $46,583 | $(44,239) |
| Net Cash Provided by Financing Activities | $10,017 | $(7,856) | $17,873 |
| Net (Decrease) Increase in Cash and Cash Equivalents | $(16,345) | $13,376 | $(29,721) |
Collaborative and Licensing Agreements
Trevi has established collaborative and licensing agreements, notably with Endo Pharmaceuticals Inc., for the development and commercialization of products incorporating nalbuphine hydrochloride. The agreement entails:
- Upfront licensing fees and milestone payments totaling $1.1 million upon achieving specific development milestones.
- Royalties based on net sales of licensed products.
Market Position and Future Prospects
Trevi's future revenue generation hinges on successfully completing clinical trials and obtaining regulatory approvals for Haduvio. The company plans to commercialize the drug independently, which will require substantial upfront investment in marketing and sales infrastructure if successful.
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Resources:
- Trevi Therapeutics, Inc. (TRVI) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Trevi Therapeutics, Inc. (TRVI)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Trevi Therapeutics, Inc. (TRVI)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.