h
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For the quarterly period ended
OR
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 9, 2023, the registrant had
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues and profitability, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the section titled “Risk Factors,” that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may differ materially from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements except as required by applicable law.
This report includes statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties as well as our own estimates. All of the market data used in this report involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys, and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for Haduvio include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.
We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. We own the trademarks Trevi® and Haduvio. Other trademarks, service marks and trade names appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to in this Quarterly Report on Form 10-Q are listed without the ® and symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names. We intend to propose Haduvio as the trade name for our oral nalbuphine ER investigational product.
RISK FACTOR SUMMARY
The following is a summary of the principal factors that make an investment in our company speculative or risky. This summary does not address all of the risks and uncertainties that we face. Additional risk and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. Additional discussion of the risks summarized in this summary and other risks that we face, can be found in the “Risk Factors” section of this Quarterly Report on Form 10-Q and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, before making an investment decision regarding our common stock. The forward-looking statements discussed above are qualified by these risk factors. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.
Table of Contents
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PART I. |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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5 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
20 |
Item 3. |
30 |
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Item 4. |
31 |
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PART II. |
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Item 1. |
31 |
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Item 1A. |
31 |
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Item 6. |
74 |
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76 |
i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
Trevi Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Amounts in thousands, except share and per share amounts)
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September 30, |
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December 31, |
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Assets |
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(Unaudited) |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Operating lease right-of-use assets |
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Other non-current assets |
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Property, equipment and leasehold improvements, net |
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Finance lease right-of-use assets |
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— |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Operating lease liabilities |
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Finance lease liabilities |
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— |
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Term loan |
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— |
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Total current liabilities |
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Operating lease liabilities |
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Finance lease liabilities |
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— |
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Term loan |
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— |
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Other non-current liabilities |
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— |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock: $ |
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Common stock: $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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( |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Trevi Therapeutics, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(unaudited)
(Amounts in thousands, except share and per share amounts)
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Three Months Ended |
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Nine Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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( |
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Other income (expense): |
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Interest income, net |
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Other income, net |
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— |
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— |
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Interest expense |
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( |
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( |
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( |
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( |
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Change in fair value of term loan derivative liability |
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— |
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— |
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— |
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( |
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Total other income (expense), net |
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( |
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Loss before income taxes |
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( |
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( |
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( |
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( |
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Income tax benefit |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Basic and diluted net loss per common share outstanding |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Weighted average common shares used in net loss per share |
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Net loss |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
( |
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Other comprehensive loss: |
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Net unrealized gains (losses) on available-for-sale marketable securities |
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( |
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( |
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( |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Trevi Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(unaudited)
(Amounts in thousands, except share amounts)
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Additional |
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Accumulated Other |
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Total |
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Common Stock |
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Paid- |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Amount |
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in Capital |
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Loss |
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Deficit |
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Equity |
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Balance at June 30, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Issuance of common stock from exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock under the at-the-market sales agreement, net of commissions and allocated fees |
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— |
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— |
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Unrealized gains on available-for-sale marketable securities |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at September 30, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Balance at June 30, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Issuance of common stock from exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock and warrants in public offering, less issuance costs |
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— |
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— |
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Issuance of common stock from warrant exercise |
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— |
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— |
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Unrealized losses on available-for-sale marketable securities |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance at September 30, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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3
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Additional |
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Accumulated Other |
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Total |
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Common Stock |
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Paid- |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Amount |
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in Capital |
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Loss |
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Deficit |
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Equity |
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Balance at December 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Issuance of common stock from exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock under the at-the-market sales agreement, net of commissions and allocated fees |
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— |
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— |
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Issuance of common stock from Employee Stock Purchase Plan |
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— |
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— |
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— |
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Issuance of common stock from pre-funded warrant exercise |
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( |
) |
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— |
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— |
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— |
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Unrealized losses on available-for-sale marketable securities |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at September 30, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Balance at December 31, 2021 |
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$ |
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$ |
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$ |
— |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Issuance of common stock from exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock under the at-the-market sales agreement, net of commissions and allocated fees |
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— |
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— |
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( |
) |
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— |
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— |
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( |
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Issuance of common stock from Employee Stock Purchase Plan |
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— |
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— |
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— |
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Issuance of common stock and warrants in public offering, less issuance costs |
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— |
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— |
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Issuance of common stock from warrant exercise |
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— |
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— |
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Unrealized losses on available-for-sale marketable securities |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at September 30, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Trevi Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(Amounts in thousands)
|
|
Nine Months Ended September 30, |
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|||||
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|
2023 |
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2022 |
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Operating activities: |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Operating lease right-of-use assets |
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Accretion/accrual of term loan discounts and debt issuance costs |
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Depreciation and amortization |
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Loss on disposal of property, equipment and leasehold improvements |
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— |
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Accretion of available-for-sale marketable securities, net |
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|
( |
) |
|
|
( |
) |
Change in fair value of term loan derivative liability |
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|
— |
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|
Changes in operating assets and liabilities: |
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||
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
( |
) |
|
|
( |
) |
Accrued expenses and other liabilities |
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|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Investing activities: |
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|
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|
||
Proceeds from maturities of available-for-sale marketable securities |
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|
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|
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||
Purchases of available-for-sale marketable securities |
|
|
( |
) |
|
|
( |
) |
Purchases of property, equipment and leasehold improvements |
|
|
( |
) |
|
|
( |
) |
Net cash provided by (used in) investing activities |
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|
|
|
|
( |
) |
|