Trevi Therapeutics, Inc 10-Q for FY2026 Q3
Trevi Therapeutics, Inc. (TRVI)
About this 10-Q
Trevi Therapeutics, Inc filed this 10-Q on November 9, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
Trevi Therapeutics, Inc. began two Phase 3 trials of Haduvio in 2026 and expects $299.4 million in cash, cash equivalents and marketable securities to fund operations into 2030. Nine-month net loss was $52.4 million, and substantial additional capital is needed. AI summary
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)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
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(Registrant’s telephone number, including area code)
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.
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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 October 31, 2026, 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 and in our most recent Annual Report on Form 10-K, particularly in the sections 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 submitted Haduvio to the U.S. Food and Drug Administration, or the FDA, as the proposed trade name for our oral nalbuphine extended-release, or ER, investigational product. The FDA has found the name to be conditionally acceptable; however, final approval of the trade name would only be granted in connection with an FDA approval of the investigational product.
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 |
17 |
Item 3. |
25 |
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Item 4. |
25 |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 5. |
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Item 6. |
27 |
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28 |
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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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Property, equipment and leasehold improvements, net |
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Other non-current assets |
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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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Total current liabilities |
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Operating lease liabilities |
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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) income |
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Accumulated deficit |
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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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2026 |
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2025 |
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2026 |
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2025 |
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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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Other income (expense): |
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Interest income, net |
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Other expense, net |
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( |
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( |
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( |
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Total other income, net |
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Loss before income taxes |
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( |
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( |
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( |
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Income tax benefit |
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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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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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$ |
( |
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Weighted average shares of common stock 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 (losses) gains 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) Income |
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Deficit |
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Equity |
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Balance at June 30, 2026 |
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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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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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( |
) |
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, 2026 |
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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, 2025 |
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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 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 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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Proceeds from disgorgement of beneficial owner's short-swing profits |
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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, 2025 |
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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) Income |
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Deficit |
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Equity |
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Balance at December 31, 2025 |
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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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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 under offering, less issuance costs |
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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, 2026 |
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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, 2024 |
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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 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 warrant exercise |
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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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Issuance of common stock under offering, less issuance costs |
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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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( |
) |
Proceeds from disgorgement of beneficial owner's short-swing profits |
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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, 2025 |
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$ |
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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)
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Nine Months Ended September 30, |
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2026 |
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2025 |
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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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Depreciation and amortization |
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Accretion of available-for-sale marketable securities, net |
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( |
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( |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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( |
) |
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( |
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Accounts payable |
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( |
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( |
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Accrued expenses and other liabilities |
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( |
) |
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Net cash used in operating activities |
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( |
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( |
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Investing activities: |
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Proceeds from maturities of available-for-sale marketable securities |
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Purchases of available-for-sale marketable securities |
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( |
) |
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( |
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Purchases of property, equipment and leasehold improvements |
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( |
) |
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( |
) |
Net cash used in investing activities |
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( |
) |
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( |
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Financing activities: |
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Proceeds from offering of common stock, net of commissions |
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Proceeds from exercises of stock options |
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|
|
|
|
||
Proceeds from Employee Stock Purchase Plan |
|
|
|
|
|
|
||
Payments of offering costs |
|
|
( |
) |
|
|
( |
) |
Proceeds from exercises of warrants |
|
|
— |
|
|
|
|
|
Proceeds from disgorgement of beneficial owner's short-swing profits |
|
|
— |
|
|
|
|
|
Payments of finance lease |
|
|
— |
|
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net increase in cash and cash equivalents |
|
|
|
|
|
|
||
Cash and cash equivalents at beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents at end of period |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these condensed consolidated financial statements.
Trevi Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share data)
Trevi Therapeutics, Inc. (“Trevi” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (“IPF”), non-IPF interstitial lung disease (“non-IPF ILD”), and refractory chronic cough (“RCC”).
Haduvio is an oral extended-release formulation of nalbuphine. Haduvio is believed to act on the cough reflex arc both centrally and peripherally as a dual acting kappa opioid receptor agonist and a mu opioid receptor antagonist (“KAMA”), hypothesized to reduce cough hypersensitivity by modulating both central neural pathways and peripheral airway nerves. Nalbuphine has been approved and marketed as an injectable for pain indications for decades in the United States (“U.S.”) and Europe. Parenteral nalbuphine is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration and in most of Europe.
Basis of Presentation
The accompanying unaudited interim Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2026 and 2025 included herein have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim information. Certain information and footnote disclosures typically prepared in accordance with GAAP have been condensed or omitted pursuant to SEC rules and regulations. The accompanying unaudited Condensed Consolidated Financial Statements and notes should be read in conjunction with the audited Consolidated Financial Statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
The accompanying Condensed Consolidated Financial Statements include the accounts of Trevi Therapeutics, Inc. and its wholly-owned subsidiary Trevi Therapeutics Limited. Intercompany balances and transactions have been eliminated.
All amounts presented are in thousands of dollars, except share and per share amounts, unless noted otherwise. The Company has evaluated events occurring subsequent to September 30, 2026 for potential recognition or disclosure in the Condensed Consolidated Financial Statements and concluded there were no subsequent events that required recognition or disclosure.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of the expenses during the reporting periods. Significant estimates and assumptions reflected in these Condensed Consolidated Financial Statements include but are not limited to the recognition of prepaid expenses, accrued expenses and research and development (“R&D”) expenses, the valuation of stock-based awards and the valuation allowance of deferred tax assets. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Unaudited Interim Financial Information
The accompanying interim Condensed Consolidated Balance Sheet as of September 30, 2026 and the Condensed Consolidated Statements of Comprehensive Loss, the Condensed Consolidated Statements of Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three and nine months ended September 30, 2026 and 2025 are unaudited. The unaudited interim Condensed Consolidated Financial Statements have been prepared on the same basis as the audited annual Consolidated Financial Statements and, in the Company’s opinion, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statements of its financial position as of September 30, 2026 and the results of its operations and its cash flows for the three and nine months ended September 30, 2026 and 2025. The results for the three and nine months ended September 30, 2026 and 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2026 or any other interim period or any future year or period.
Concentrations of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high credit quality, and the Company has not experienced any losses on these deposits. The Company’s marketable securities potentially subject the Company to concentrations of credit risk. The Company’s cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in business operations.
The Company has no off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign-hedging arrangements.
Cash Equivalents
The Company classifies short-term, highly liquid investments with an original term of three months or less at the date of purchase as cash equivalents.
Marketable Securities
The Company generally invests its excess cash in money market funds and investment grade short- to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents or marketable securities on the Condensed Consolidated Balance Sheets. Marketable securities with an original maturity date greater than 90 days at each balance sheet date are classified as short-term. Marketable securities are classified as current assets as these investments are intended to be available to the Company for use in funding current operations. All of the Company’s marketable securities are considered available-for-sale and are reported at fair value. Unrealized gains and losses, other than credit-related losses, are included in accumulated other comprehensive income (loss) as a component of stockholders’ equity. Credit losses are identified when the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. Credit losses, and any subsequent improvements, are recognized in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss through an allowance for credit losses, limited to the amount by which fair value is below amortized cost. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. Realized gains and losses, if any, on marketable securities are included in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. The cost of securities sold is determined using specific identification.
On a quarterly basis, the Company evaluates its marketable securities in an unrealized loss position for impairment. The Company first assesses whether it intends to sell, or whether it is more likely than not that it will be required to sell, the security before recovery of its amortized cost basis. If either criterion is met, the security’s amortized cost basis is written down to fair value through earnings. For securities that do not meet these criteria, the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this evaluation, the Company considers factors such as the extent to which fair value is less than amortized cost, changes in the credit quality of debt instrument issuers, and other publicly available information that may affect the collectibility of the marketable security.
Fair Value Measurements
The Company’s financial instruments have consisted of cash and cash equivalents, available-for-sale marketable securities, other current assets, accounts payable, accrued expenses and warrants to acquire the Company’s common stock. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. The carrying amounts of cash and cash equivalents, other current assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Available-for-sale marketable securities are reported at their fair values, based upon pricing of securities with the same or similar investment characteristics as provided by third-party pricing services, as described below. The warrants to acquire the Company’s common stock are not required to be accounted for at fair value.
Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, and requires certain disclosures about fair value measurements. The valuation techniques included in the guidance are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect market assumptions and are classified into the following fair value hierarchy:
Level 1—Observable inputs—quoted prices in active markets for identical assets and liabilities.
Level 2—Observable inputs other than the quoted prices in active markets for identical assets and liabilities—such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data.
Level 3—Unobservable inputs—includes amounts derived from valuation models where one or more significant inputs are unobservable and require the Company to develop relevant assumptions.
Valuation Techniques - Level 2 Inputs
The Company estimates the fair values of its financial instruments categorized as Level 2 in the fair value hierarchy, including U.S. treasury securities, U.S. government agency obligations, corporate bonds, commercial paper, asset-backed securities and municipal bonds, by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. The Company obtains a single price for each financial instrument and does not adjust the prices obtained from the pricing service.
7
Property, Equipment and Leasehold Improvements
Property, equipment and leasehold improvements (consisting of furniture, computer and office equipment and leasehold improvements) are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets (
Impairment of Long-Lived Assets
The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. The Company has not recognized any significant impairment charges from inception through September 30, 2026.
Foreign Currency Transactions
The Company, at times, contracts with vendors and consultants outside of the U.S., resulting in liabilities denominated in foreign currency. The transactions are recorded in U.S. dollars on the transaction dates and any currency fluctuation through the payment date is recorded as currency gains or losses in other income (expense), net in the Condensed Consolidated Statements of Comprehensive Loss.
Deferred Offering Costs
The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the financings. Should an in-process equity financing no longer be considered probable of being consummated, the deferred offering costs are expensed immediately as a charge to general and administrative expenses.
Research and Development (“R&D”) Expenses
All of the Company’s R&D expenses consist of expenses incurred in connection with the development of Haduvio. These expenses include certain payroll and personnel expenses, including stock-based compensation, consulting costs, contract manufacturing costs and fees paid to contract research organizations (“CROs”) to conduct certain R&D activities on the Company’s behalf. The Company expenses both internal and external R&D expenses as they are incurred.
The Company has entered into agreements with CROs, contract manufacturing organizations (“CMOs”) and other companies that provide services in connection with the Company’s R&D activities. The value of goods and services received from CROs and CMOs in the reporting period are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, timing of payments made and contracted costs. The estimated costs of R&D provided, but not yet invoiced, are included in accrued expenses on the Condensed Consolidated Balance Sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs, CMOs and other companies under these arrangements in advance of the performance of the related services are recorded as prepaid expenses or as other current assets on the Condensed Consolidated Balance Sheets, as applicable, and are recognized as expenses as the goods are delivered or the related services are performed.
Patent Costs
All patent-related costs in connection with filing and prosecuting patent applications are expensed to general and administrative expense as incurred, as recoverability of such expenditures is uncertain.
Warrants
The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and then in accordance with ASC 815, Derivatives and Hedging (“ASC 815”), depending on the specific terms of the warrant. Under ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares.
If the warrants do not meet liability classification under ASC 480, the Company assesses the requirements under ASC 815, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded in the statements of comprehensive loss as a gain or loss. For equity classified warrants, no changes in fair value are recognized after the issuance date.
8
Stock-Based Compensation
The Company accounts for stock-based compensation arrangements with employees and non-employees for consultancy services in accordance with ASC 718, Stock Compensation (“ASC 718”). ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based awards including stock options. The Company’s determination of the fair value of stock-based awards on the date of grant utilizes the Black-Scholes valuation model for stock options with time-based and performance-based vesting and is impacted by the price of its common stock as well as changes in assumptions regarding a number of subjective variables. These variables include the expected term that stock options will remain outstanding, expected common stock price volatility over the term of the stock options, risk-free interest rates and expected dividends.
Changes in the variables can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require analysis and judgment to develop.
Expected Term—The expected term assumption represents the weighted average period that the stock-based awards are expected to be outstanding. The Company has elected to use the “simplified method” for estimating the expected term of its stock options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option.
Expected Volatility—The Company estimates expected volatility based on a combination of its own historical stock price volatility, when sufficient trading history is available, and the historical volatility of a group of publicly traded peer companies. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies.
Expected Dividend—The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company currently has
Risk-Free Interest Rate—The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues similar in duration to the expected term of the stock-based award.
The fair value is recognized over the period during which an optionee is required to provide services in exchange for the stock option, known as the requisite service period (usually the vesting period) on a straight-line basis. For performance-based vesting, the fair value is recognized when it is probable the performance conditions will be achieved. The Company reassesses the probability of achieving the performance conditions at each reporting date. Forfeitures are accounted for as they occur.
Income Taxes
The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized.
The Company applies the provisions of ASC 740, Income Taxes (“ASC 740”), which prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return. These Condensed Consolidated Financial Statements reflect expected future tax consequences of such positions presuming the taxing authorities possess full knowledge of the position and all relevant facts. There are no material uncertainties regarding the tax positions that the Company has taken through September 30, 2026 and December 31, 2025. The Company does not have any interest or penalties accrued related to tax positions as it does not have any unrecognized tax benefits.
Leases
Under ASC 842, Leases, the Company determines if an arrangement is a lease at its inception. Leases are classified as either operating or finance, based on the Company’s evaluation of certain criteria. If a lease has a term greater than one year, the lease is recognized in the balance sheet as a right-of-use asset and a lease liability at lease commencement. The Company elected the short-term lease practical expedient, therefore, if a lease has a term less than one year, the Company will not recognize the lease on its balance sheet. The right-of-use asset represents the Company’s right-of-use to an underlying asset for the term of the lease and the lease liability represents the Company’s obligation to make lease payments arising from the lease. If the Company’s leases do not provide an implicit rate within the lease, the Company uses its incremental borrowing rate, based on information available at the commencement date of the lease to determine the present value of the lease payments.
Operating lease right-of-use assets and operating lease liabilities are determined and recognized on the commencement date of the lease based on the present value of lease payments over the term of the lease. For operating leases, rent expense is recognized on a straight-line basis over the term of the lease, and right-of-use assets are subsequently re-measured to reflect the effect of uneven lease payments.
For finance leases, right-of-use assets are amortized on a straight-line basis over the shorter of the lease term or the useful life of the underlying asset. Expenses for finance leases include the amortization of right-of-use assets, which is recorded as depreciation and amortization expense, and interest expense, which reflects interest accrued on the lease liability.
9
Basic and Diluted Net Loss per Common Share
Basic and diluted net loss per common share outstanding is determined by dividing net loss by the weighted average shares of common stock outstanding during the period. Basic shares outstanding includes the weighted average effect of the Company’s outstanding pre-funded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock.
For all periods presented, shares issuable upon exercise of stock options and warrants to purchase shares of common stock (other than pre-funded warrants) have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average shares of common stock used to calculate both basic and diluted net loss per share are the same for each of the periods presented.
Segments
The Company operates and manages its business as
The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
Comprehensive Loss
Comprehensive loss represents the net change in stockholders’ equity during a period from sources other than transactions with stockholders. As reflected in the accompanying Condensed Consolidated Statements of Comprehensive Loss, the Company's comprehensive loss is comprised of net losses and unrealized gains and losses on marketable securities.
Recently Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Improvements to Income Tax Disclosures, which requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The Company
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which requires disaggregation and disclosure of specified information about certain costs and expenses in the notes to the financial statements. The standard is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2024-03.
The fair value and amortized cost of available-for-sale marketable securities by major security type are presented in the following tables as of the periods presented:
|
|
September 30, 2026 |
|
|||||||||||||
Type of security |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Estimated Fair Value |
|
||||
U.S. treasury securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Corporate bonds |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Commercial paper |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
U.S. government agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Asset backed securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total marketable securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
10
|
|
December 31, 2025 |
|
|||||||||||||
Type of Security |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Estimated Fair Value |
|
||||
U.S. treasury securities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Corporate bonds |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Asset backed securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government agency securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total marketable securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
The net amortized cost and fair value of available-for-sale marketable securities are presented in the following table as of the periods presented by contractual maturity. Actual maturities may differ from contractual maturities because securities may be restructured, called or prepaid, or the Company may intend to sell a security prior to maturity.
|
|
September 30, 2026 |
|
|||||
|
|
Amortized Cost |
|
|
Fair Value |
|
||
Due to mature: |
|
|
|
|
|
|
||
Less than one year |
|
$ |
|
|
$ |
|
||
One year through three years |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
|
|
December 31, 2025 |
|
|||||
|
|
Amortized Cost |
|
|
Fair Value |
|
||
Due to mature: |
|
|
|
|
|
|
||
Less than one year |
|
$ |
|
|
$ |
|
||
One year through three years |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
During the three and nine months ended September 30, 2026 and 2025, there were
As of September 30, 2026 and December 31, 2025,
As of September 30, 2026 and December 31, 2025, accrued interest receivables on the Company’s were $
The following table summarizes the Company’s financial assets and financial liabilities measured at fair value on a recurring basis and the basis for that measurement, by level within the fair value hierarchy, as follows:
|
|
|
|
Fair Value Measurement Using: |
|
|||||||||||||
Balance Sheet Classification |
|
Type of Instrument |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
September 30, 2026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities |
|
U.S. treasury securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
Corporate bonds |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
Commercial paper |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
U.S. government agency securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
Asset backed securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total assets |
|
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
11
|
|
|
|
Fair Value Measurement Using: |
|
|||||||||||||
Balance Sheet Classification |
|
Type of Instrument |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
December 31, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities |
|
U.S. treasury securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
Commercial paper |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
Corporate bonds |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
Asset backed securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Marketable securities |
|
U.S. government agency securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total assets |
|
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Accrued expenses consisted of the following:
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Accrued compensation and benefits |
|
$ |
|
|
$ |
|
||
Accrued R&D |
|
|
|
|
|
|
||
Accrued consulting and professional fees |
|
|
|
|
|
|
||
Accrued other |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
On June 3, 2026, the Company filed an amendment to the Company’s Restated Certificate of Incorporation, as amended to increase the number of authorized shares of the Company’s common stock from
The Company had reserved shares of common stock for future issuance as shown in the table below:
|
|
September 30, |
|
|
December 31, |
|
||
Shares of common stock reserved for future issuance upon exercise of outstanding warrants and pre-funded warrants |
|
|
|
|
|
|
||
Shares of common stock reserved for future issuance upon exercise under the Amended and Restated 2019 Stock Incentive Plan |
|
|
|
|
|
|
||
Shares of common stock reserved for future issuance under the 2019 Employee Stock Purchase Plan |
|
|
|
|
|
|
||
Shares of common stock reserved for future issuance upon exercise under the 2012 Stock Incentive Plan |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
At-the-Market Offering
In June 2023, the Company entered into an at-the-market sales agreement with Leerink Partners, LLC (formerly SVB Securities LLC) (the “ATM Sales Agreement”), under which the Company may issue and sell shares of common stock, from time to time by any method that is deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company is not obligated to make any sales of its common stock under the ATM Sales Agreement.
In November 2025, the Company filed an automatic universal shelf registration statement on Form S-3 (the “2025 Shelf Registration Statement”) with the SEC, which became effective upon filing. The 2025 Shelf Registration Statement permits the Company to offer and sell an indeterminate amount of common stock, preferred stock, debt securities, units and/or warrants from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale. The 2025 Shelf Registration Statement was filed to replace the Company’s prior universal shelf registration statement. Concurrently with the filing of the 2025 Shelf Registration Statement, the Company filed a new prospectus supplement pursuant to which shares of the Company’s common stock having an aggregate offering price of up to $
Private Placements
On April 6, 2022, the Company entered into a securities purchase agreement with certain purchasers, pursuant to which the Company agreed to issue and sell to the purchasers, in a private placement priced at-the-market under Nasdaq rules, (i)
12
shares of the Company’s common stock at a purchase price of $
On October 18, 2021, the Company issued and sold to New Enterprise Associates 16, L.P., an existing stockholder of the Company (“NEA”) and related party, in a private placement,
Registered Offerings
On April 16, 2026, the Company issued and sold
On June 5, 2025, the Company issued and sold
On September 27, 2022, the Company issued and sold
Warrants
Warrant activity, including activity related to pre-funded warrants, is shown in the table below:
|
|
Number of |
|
|
Number of |
|
|
Total Number of |
|
|
Weighted |
|
||||
Outstanding as of December 31, 2025 |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Outstanding as of September 30, 2026 |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
13
The pre-funded and common stock warrants are classified as equity in accordance with ASC 815 given that the pre-funded and common stock warrants are indexed to the Company’s own shares of common stock and meet the requirements to be classified in permanent equity.
Stock-Based Awards
The 2012 Stock Incentive Plan (the “2012 Plan”) was adopted by the Company’s board of directors and stockholders. The 2012 Plan provides for the issuance of stock-based awards to the Company’s employees, officers, directors, consultants and advisors. The Company’s board of directors administers the 2012 Plan. In April 2019, the Company’s board of directors adopted a resolution effective May 7, 2019, that
In April 2019, the Company’s board of directors adopted the 2019 Stock Incentive Plan (the “2019 Plan”), which became effective on May 7, 2019. The 2019 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The Company’s employees, officers, directors, consultants and advisors are eligible to receive awards under the 2019 Plan. The 2019 Plan is administered by the Company’s board of directors.
In April 2025, the Company’s board of directors approved, and in June 2025 the Company’s stockholders subsequently approved, an amendment to the 2019 Plan, which (i) increased the number of shares authorized for issuance under the plan by
In April 2026, the Company’s board of directors approved, and in June 2026 the Company’s stockholders subsequently approved, an amendment and restatement of the 2019 Plan, which (i) increased the number of shares authorized for issuance under the 2019 Plan by
In February 2024, the Company granted options to purchase
In February 2026, the Company granted PSOs to purchase
A summary of the Company’s combined stock option activity for the 2019 Plan and the 2012 Plan is as follows:
|
|
Number of |
|
|
Weighted |
|
||
|
|
|
|
|
|
|
||
Outstanding as of December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
$ |
|
||
Exercised |
|
|
( |
) |
|
$ |
|
|
Forfeited |
|
|
( |
) |
|
$ |
|
|
Expired |
|
|
( |
) |
|
$ |
|
|
Outstanding as of September 30, 2026 |
|
|
|
|
$ |
|
||
Options exercisable as of September 30, 2026 |
|
|
|
|
$ |
|
||
Options unvested as of September 30, 2026 |
|
|
|
|
$ |
|
||
14
In April 2019, the Company’s board of directors adopted the 2019 Employee Stock Purchase Plan (the “2019 ESPP”), which became effective on May 7, 2019. The 2019 ESPP is administered by the Company’s board of directors.
The following table summarizes the classifications of stock-based compensation expenses for the 2012 Plan, the 2019 Plan and the 2019 ESPP recognized in the Condensed Consolidated Statements of Comprehensive Loss:
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
General and administrative expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As of September 30, 2026 and December 31, 2025, the Company maintained a full valuation allowance on deferred tax assets. The income tax benefit recorded during the three and nine months ended September 30, 2026 and 2025 was for the Company’s estimates for its state research and development tax credits in each given year.
The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company:
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted average shares of common stock used in net loss per share attributable to common stockholders, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per common share outstanding |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Basic shares outstanding includes the weighted average effect of the Company’s pre-funded warrants from the date of issuance, the exercise of which requires little or no consideration for the delivery of shares of common stock. As of both September 30, 2026 and December 31, 2025, the Company had pre-funded warrants to purchase
The Company’s potential dilutive securities, which include stock options and warrants that are not pre-funded, have been excluded from the computation of diluted net loss per share attributable to common stockholders whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
|
|
Shares as of September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Stock Options |
|
|
|
|
|
|
||
Warrants |
|
|
|
|
|
|
||
Total potential shares of common stock |
|
|
|
|
|
|
||
The Company's reportable segment is the business of developing and commercializing the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with IPF, non-IPF ILD, and RCC.
15
The accounting policies of the segment are described in Note 2 of the notes to the Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.
The following table presents reportable segment loss, including significant expense categories, attributable to the Company’s reportable segment for the periods presented:
|
|
Three Months Ended |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Chronic cough in IPF clinical trial expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Refractory chronic cough clinical trial expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other clinical trials and studies 1 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical trial material |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other clinical development expenses 2 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Employee compensation (excluding stock compensation expense) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment items 3 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income, net |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
(1)
(2)
(3)
A significant portion of the Company’s development activities are outsourced to third parties under agreements, including with CROs and contract manufacturers in connection with the production of clinical trial materials. These arrangements may require the Company to pay termination costs to the third parties for reimbursement of costs and expenses incurred in the event of the orderly termination of contractual services.
The Company also has commitments under lease and licensing agreements. There have been no material changes to the Company's lease obligations or licensing agreements from those disclosed in the consolidated financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
During the three months ended September 30, 2026, the Company made multiple purchases of active pharmaceutical ingredient from Par Health for use in the manufacture of the Company's product candidate, Haduvio, totaling approximately $
16
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our Condensed Consolidated Financial Statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited Consolidated Financial Statements and related notes for the year ended December 31, 2025 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or SEC, on March 17, 2026. Some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. 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. We have based these forward-looking statements on our current expectations and projections about future events. The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report on Form 10-Q and in our most recent Annual Report on Form 10-K, including the risks identified under “Risk Factors” of such reports, as well as in our other SEC filings.
Our actual results and the timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. Statements made herein are as of the date of the filing of this Quarterly Report on Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report on Form 10-Q, they may not be predictive of results or developments in future periods. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made.
Overview
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis, or IPF, non-IPF interstitial lung disease, or non-IPF ILD, and refractory chronic cough, or RCC. Haduvio is an oral extended-release formulation of nalbuphine. Haduvio is believed to act on the cough reflex arc both centrally and peripherally as a dual acting kappa opioid receptor agonist and a mu opioid receptor antagonist, or KAMA, hypothesized to reduce cough hypersensitivity by modulating both central neural pathways and peripheral airway nerves. Nalbuphine has been approved and marketed as an injectable for pain indications for decades in the United States, or the U.S., and Europe. Parenteral nalbuphine is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration and in most of Europe.
IPF-related Chronic Cough Program. We are initially developing Haduvio for the treatment of IPF-related chronic cough, which is a progressive fibrosing interstitial lung disease associated with high mortality rates.
In June 2025, we announced positive topline results from our Phase 2b CORAL trial, which was a dose-ranging study evaluating the efficacy, safety and tolerability of Haduvio for IPF-related chronic cough. The Phase 2b CORAL trial was a randomized, double-blind, placebo-controlled, parallel-arm design that evaluated three different dose groups of Haduvio (108 mg twice-a-day, or BID, 54 mg BID and 27 mg BID) as compared to placebo. The primary efficacy endpoint for the trial was the relative change in 24-hour cough frequency (coughs per hour) for the modified intent-to-treat, or mITT, population at the end of Week 6 versus Baseline for Haduvio compared to placebo, as measured via an objective cough monitor. The mITT population consists of all randomized patients who received at least one dose of study drug or placebo (n=165). The primary efficacy endpoint in the Phase 2b CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6. The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved statistically significant reductions from Baseline of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01), respectively, compared to a placebo reduction from Baseline of 16.9%.
We have completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration, or the FDA. At the meeting, we gained overall alignment on the plan for the remaining clinical trials to potentially support a New Drug Application, or NDA, submission for Haduvio, including two pivotal Phase 3 clinical trials and the remaining Phase 1 clinical trials. We initiated our Phase 3 OCEAN-1 trial in the second quarter of 2026 and initiated our Phase 3 OCEAN-2 trial in the third quarter of 2026. The two Phase 3 trials are being conducted as randomized, double-blind, placebo-controlled, multicenter global trials with 2:1 randomization. The protocol for the Phase 3 OCEAN-1 trial provides for the enrollment of approximately 300 patients and 52 weeks of fixed dosing with Haduvio 54 mg BID, with the primary efficacy endpoint measured at 24 weeks of fixed dosing and the safety endpoints measured over the trial duration. The protocol for the Phase 3 OCEAN-2 trial provides for the enrollment of approximately 200 patients and 12
17
weeks of fixed dosing with Haduvio 54 mg BID with the primary efficacy endpoint measured at 12 weeks of fixed dosing and the safety endpoints measured over the trial duration. The primary efficacy endpoint for both trials is the relative change from Baseline in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for Haduvio compared with placebo. A key secondary endpoint for both trials is absolute change from Baseline in the Cough Severity Numerical Rating Scale, or CS-NRS. We expect to have topline results from the Phase 3 OCEAN-1 trial in the first half of 2028 and from the Phase 3 OCEAN-2 trial in the second half of 2027.
Non-IPF ILD-related Chronic Cough Program. We are also developing Haduvio for the treatment of non-IPF ILD-related chronic cough. We met with the FDA in October 2026 to discuss the proposed clinical development program for this indication. Based on that meeting, we plan to initiate a Phase 2 dose-ranging trial that will be conducted as a randomized, double-blind, placebo-controlled, multicenter trial and will study two doses of Haduvio (54 mg BID and 27 mg BID) as compared to placebo. The protocol for the Phase 2 dose-ranging trial provides for the enrollment of approximately 120 patients and 12 weeks of fixed dosing. The primary efficacy endpoint will be the relative change from Baseline in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for Haduvio compared to placebo. We expect to initiate this trial in the first quarter of 2027, subject to review of the trial protocol by the FDA, and we expect topline results from the Phase 2 trial in the first half of 2028.
We received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application with claims covering dosing nalbuphine ER in hepatically impaired patients with non-IPF ILD-related chronic cough. Once issued, the patent is expected to expire in 2041. Based on our projected product labeling, we believe this patent will be listable on the Orange Book for the non-IPF ILD-related chronic cough indication.
RCC Program. We are developing Haduvio for the treatment of RCC, which affects approximately 2-3 million adults in the U.S. and is related to biological changes in the central and peripheral nervous systems that lower the threshold of the cough reflex. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burden for patients and those around them.
In March 2025, we announced positive topline data from our Phase 2a proof-of-concept clinical trial of Haduvio for the treatment of patients with RCC, which we refer to as the Phase 2a RIVER trial. The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study that was designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for the treatment of patients with RCC. The primary endpoint of the trial was the mean change in 24-hour cough frequency, as determined by an objective cough monitor, for the full analysis set population (n=66). In the trial, Haduvio met the primary endpoint at Day 21 with a statistically significant reduction in the objective 24-hour cough frequency of 67% from Baseline and 57% from Baseline on a placebo-adjusted basis (p<0.0001). Planned analyses of all pre-specified secondary endpoints, including patient-reported endpoints, at the end of treatment were also statistically significant. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials in other patient populations and there were no serious adverse events reported in the trial.
We initiated our Phase 2b LAKE trial of Haduvio for the treatment of patients with RCC in the second quarter of 2026. We are conducting this randomized, double-blind, placebo-controlled, multicenter trial in the United Kingdom, Canada, and Poland. The protocol for the Phase 2b LAKE trial provides for the enrollment of approximately 100 patients and is designed to evaluate three different dose groups of Haduvio (54 mg BID, 27 mg BID, and 27 mg once daily, or QD) as compared to placebo. The primary efficacy endpoint for the trial is the relative change from Baseline in 24-hour cough frequency (coughs per hour) at the end of Week 6, as determined by an objective cough monitor, for Haduvio compared with placebo. The protocol provides for a sample size re-estimation, or SSRE, analysis once 50% of the patients complete treatment. Based on projected enrollment, we expect to report the outcome of the SSRE analysis early in the first quarter of 2027. We expect to report topline results from the full trial in the second half of 2027.
Other NDA Supportive Studies. We also plan to continue to progress and advance Phase 1 NDA supportive studies necessary for regulatory approval in parallel with our clinical program.
Since commencing operations in 2011, we have devoted substantially all of our efforts and financial resources to the clinical development of Haduvio. We have not generated any revenue from product sales and, as a result, we have never been profitable and have incurred net losses in each year since commencement of our operations. As of September 30, 2026, we had an accumulated deficit of $382.2 million, primarily as a result of research and development and general and administrative expenses. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize Haduvio for the treatment of chronic cough in patients with IPF, non-IPF ILD, or RCC and we can provide no assurance that we will ever generate significant revenue or profits.
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $299.4 million. We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date of issuance of the Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.
We expect to incur substantial expenditures in the foreseeable future as we advance Haduvio through clinical development, the regulatory approval process and, if approved, commercial launch activities. Specifically, in the near term, we expect to incur substantial expenses relating to the trials we are conducting and plan to conduct for Haduvio including our ongoing Phase 3 OCEAN-1 and OCEAN-2 trials, each for the treatment of IPF-related chronic cough, our planned Phase 2 dose-ranging trial of Haduvio for the
18
treatment of non-IPF ILD-related chronic cough, our ongoing Phase 2b LAKE clinical trial of Haduvio for the treatment of patients with RCC, including the planned SSRE and our ongoing and planned Phase 1 NDA supportive studies.
We will need substantial additional funding to support our continuing operations and pursue development and commercialization of Haduvio. Until such time that we can generate significant revenue from sales of Haduvio, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of Haduvio for one or more indications or delay our efforts to expand our product pipeline.
Components of Operating Results
Operating Expenses
Research and Development Expenses
For the periods presented, all of our research and development expenses consist of expenses incurred in connection with the development of Haduvio. These expenses include personnel-related costs, including stock-based compensation, consulting costs, fees paid to contract research organizations, or CROs, to conduct certain research and development activities on our behalf, contract manufacturing costs and fees paid to other vendors that provide goods and services related to our clinical trials. We do not allocate all of our costs by each indication for which we are developing Haduvio, as a significant amount of our development activities broadly support all indications. In addition, several of our departments support our Haduvio drug candidate development program and we do not identify internal costs for each potential indication.
We expect our research and development expenses to increase as we pursue our development program, pursue regulatory approval of Haduvio in the U.S., Europe and other jurisdictions outside the U.S. and prepare for a possible commercial launch of Haduvio. Predicting the timing or the cost to conduct our Haduvio development program and prepare for a possible commercial launch of Haduvio is difficult and delays may occur because of many factors including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on our development program. Furthermore, we are unable to predict when or if Haduvio will receive regulatory approval in the U.S. or elsewhere with any certainty.
General and Administrative Expenses
General and administrative expenses consist principally of personnel-related costs, including stock-based compensation for personnel in executive, finance, commercial and other administrative functions; professional fees for legal, information technology, consulting and accounting services; as well as rent and other general operating expenses not otherwise classified as research and development expenses.
We anticipate that our general and administrative expenses will increase as a result of increased personnel costs, including stock-based compensation and expanded infrastructure. We also anticipate that our general and administrative expenses will increase as we expect to continue to incur increased costs as we continue to prepare for compliance with Section 404 of the Sarbanes-Oxley Act of 2002, or SOX 404(b).
Other Income (Expense), Net
Interest Income, Net
Interest income, net consists of interest earned primarily on our cash, cash equivalents and marketable securities as well as accretion of discounts/amortization of premiums on purchases of marketable securities.
Other (Expense) Income, Net
Other (expense) income, net consists of foreign currency transaction gains and losses.
19
Results of Operations
Comparison of the Three Months Ended September 30, 2026 and 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Three Months Ended September 30, |
|
|||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
19,064 |
|
|
$ |
10,085 |
|
|
$ |
8,979 |
|
General and administrative |
|
|
5,422 |
|
|
|
3,831 |
|
|
|
1,591 |
|
Total operating expenses |
|
|
24,486 |
|
|
|
13,916 |
|
|
|
10,570 |
|
Loss from operations |
|
|
(24,486 |
) |
|
|
(13,916 |
) |
|
|
(10,570 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|||
Interest income, net |
|
|
3,018 |
|
|
|
2,101 |
|
|
|
917 |
|
Other expense, net |
|
|
(3 |
) |
|
|
(2 |
) |
|
|
(1 |
) |
Total other income, net |
|
|
3,015 |
|
|
|
2,099 |
|
|
|
916 |
|
Loss before income taxes |
|
|
(21,471 |
) |
|
|
(11,817 |
) |
|
|
(9,654 |
) |
Income tax benefit |
|
|
(19 |
) |
|
|
(15 |
) |
|
|
(4 |
) |
Net loss |
|
$ |
(21,452 |
) |
|
$ |
(11,802 |
) |
|
$ |
(9,650 |
) |
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses for the periods indicated (in thousands):
|
|
Three Months Ended September 30, |
|
|||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Clinical development expenses |
|
$ |
15,097 |
|
|
$ |
7,405 |
|
|
$ |
7,692 |
|
Personnel and related expenses |
|
|
2,187 |
|
|
|
1,970 |
|
|
|
217 |
|
Stock-based compensation expenses |
|
|
1,388 |
|
|
|
538 |
|
|
|
850 |
|
Other research and development expenses |
|
|
392 |
|
|
|
172 |
|
|
|
220 |
|
Total research and development expenses |
|
$ |
19,064 |
|
|
$ |
10,085 |
|
|
$ |
8,979 |
|
Research and development expenses for the three months ended September 30, 2026 increased to $19.1 million from $10.1 million for the corresponding period in 2025, primarily due to increased clinical development expenses associated with our Phase 3 OCEAN-1 trial, our Phase 2b LAKE trial, our Phase 3 OCEAN-2 trial and costs associated with acquiring active pharmaceutical ingredients for these trials, as well as increases in stock-based compensation and personnel-related expenses, resulting from increased headcount. Stock-based compensation expense also increased due to higher grant-date fair value of 2026 awards, driven by our higher stock price, and expense related to performance-based stock options granted in 2026. These increases were partially offset by decreased costs for our Phase 1 NDA supportive studies and Phase 2b CORAL trial.
General and Administrative Expenses
General and administrative expenses for the three months ended September 30, 2026 increased to $5.4 million from $3.8 million for the corresponding period in 2025, primarily due to an increase in stock-based compensation and personnel-related expenses, resulting from increased headcount. Stock-based compensation expense also increased due to higher grant-date fair value of 2026 awards, driven by our higher stock price, and expense related to performance-based stock options granted in 2026.
Other Income, Net
Other income, net for the three months ended September 30, 2026 was $3.0 million compared to $2.1 million for the corresponding period in 2025. The change was primarily due to an increase in interest income from higher invested cash equivalents and marketable securities balances.
20
Comparison of the Nine Months Ended September 30, 2026 and 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
44,157 |
|
|
$ |
27,285 |
|
|
$ |
16,872 |
|
General and administrative |
|
|
15,751 |
|
|
|
11,823 |
|
|
|
3,928 |
|
Total operating expenses |
|
|
59,908 |
|
|
|
39,108 |
|
|
|
20,800 |
|
Loss from operations |
|
|
(59,908 |
) |
|
|
(39,108 |
) |
|
|
(20,800 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|||
Interest income, net |
|
|
7,409 |
|
|
|
4,633 |
|
|
|
2,776 |
|
Other expense, net |
|
|
(1 |
) |
|
|
(16 |
) |
|
|
15 |
|
Total other income, net |
|
|
7,408 |
|
|
|
4,617 |
|
|
|
2,791 |
|
Loss before income taxes |
|
|
(52,500 |
) |
|
|
(34,491 |
) |
|
|
(18,009 |
) |
Income tax benefit |
|
|
(59 |
) |
|
|
(48 |
) |
|
|
(11 |
) |
Net loss |
|
$ |
(52,441 |
) |
|
$ |
(34,443 |
) |
|
$ |
(17,998 |
) |
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses for the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Clinical development expenses |
|
$ |
33,389 |
|
|
$ |
19,354 |
|
|
$ |
14,035 |
|
Personnel and related expenses |
|
|
6,186 |
|
|
|
5,702 |
|
|
|
484 |
|
Stock-based compensation expenses |
|
|
3,605 |
|
|
|
1,660 |
|
|
|
1,945 |
|
Other research and development expenses |
|
|
977 |
|
|
|
569 |
|
|
|
408 |
|
Total research and development expenses |
|
$ |
44,157 |
|
|
$ |
27,285 |
|
|
$ |
16,872 |
|
Research and development expenses for the nine months ended September 30, 2026 increased to $44.2 million from $27.3 million for the corresponding period in 2025, primarily due to increased clinical development expenses associated with our Phase 3 OCEAN-1 trial, our Phase 2b LAKE trial, our Phase 3 OCEAN-2 trial and costs associated with acquiring active pharmaceutical ingredients for these trials, as well as increases in stock-based compensation and personnel-related expenses, resulting from increased headcount. Stock-based compensation expense also increased due to higher grant-date fair value of 2026 awards, driven by our higher stock price, and expense related to performance-based stock options granted in 2026. These increases were partially offset by decreased costs for our Phase 2b CORAL trial and Phase 2a RIVER trial.
General and Administrative Expenses
General and administrative expenses for the nine months ended September 30, 2026 increased to $15.8 million from $11.8 million for the corresponding period in 2025, primarily due to an increase in stock-based compensation and personnel-related expenses, resulting from increased headcount. Stock-based compensation expense also increased due to higher grant-date fair value of 2026 awards, driven by our higher stock price, and expense related to performance-based stock options granted in 2026.
Other Income, Net
Other income, net for the nine months ended September 30, 2026 was $7.4 million compared to $4.6 million for the corresponding period in 2025. The change was primarily due to an increase in interest income from higher invested cash equivalents and marketable securities balances.
Liquidity and Capital Resources
Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations.
On April 16, 2026, we issued and sold 11,600,000 shares of our common stock to the public in an underwritten offering, or the April 2026 Offering, at an offering price of $13.00 per share of common stock pursuant to an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners LLC, as representatives of the several underwriters. In connection with the offering, we also granted the underwriters a 30-day option to purchase up to an additional 1,740,000 shares of common stock at the price to the public, less underwriting discounts and commissions. The underwriters option was exercised in full and settled in cash, concurrent with the
21
closing of the offering. The April 2026 Offering resulted in aggregate gross proceeds to us of $173.4 million or net proceeds to us of approximately $162.3 million, after deducting underwriting discounts and commissions and offering expenses.
On June 5, 2025, we issued and sold 17,400,000 shares of our common stock to the public in an underwritten offering, or the June 2025 Offering, at an offering price of $5.75 per share of common stock pursuant to an underwriting agreement with Morgan Stanley & Co. LLC, Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated and Cantor Fitzgerald & Co., as representatives of the several underwriters. In connection with the offering, we also granted the underwriters a 30-day option to purchase up to an additional 2,610,000 shares of common stock at the price to the public, less underwriting discounts and commissions. The underwriters' option was exercised in full and settled in cash, concurrent with the offering. The June 2025 Offering resulted in aggregate gross proceeds to us of approximately $115.1 million.
On December 17, 2024, we issued and sold 12,500,000 shares of our common stock to certain investors in an underwritten registered direct offering, or the December 2024 Offering, at an offering price of $4.00 per share of common stock pursuant to an underwriting agreement with Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated, and Oppenheimer & Co. Inc, as representatives of the several underwriters. The December 2024 Offering resulted in aggregate gross proceeds to us of approximately $50.0 million.
In June 2023, we filed with the SEC a universal shelf registration statement on Form S-3, or the 2023 Shelf Registration Statement, which allowed us to offer and sell up to $200.0 million of common stock, preferred stock, debt securities, units and/or warrants from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale. The 2023 Shelf Registration Statement was declared effective on August 15, 2023. Further, in June 2023, we entered into a sales agreement with Leerink Partners, LLC (formerly SVB Securities LLC), which we refer to as the ATM Sales Agreement, under which we may issue and sell shares of common stock, from time to time by any method that is deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act. We are not obligated to make any sales of our common stock under the ATM Sales Agreement. We filed a prospectus under the 2023 Shelf Registration Statement for the offer and sale of shares of our common stock having an aggregate offering price of up to $75.0 million pursuant to the ATM Sales Agreement.
In November 2025, we filed an automatic universal shelf registration statement on Form S-3, or the 2025 Shelf Registration Statement, with the SEC, which became effective upon filing. The 2025 Shelf Registration Statement permits us to offer and sell an indeterminate amount of common stock, preferred stock, debt securities, units and/or warrants from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale. The 2025 Shelf Registration Statement was filed to replace the 2023 Shelf Registration Statement. Concurrently with the filing of the 2025 Shelf Registration Statement, we filed a new prospectus supplement pursuant to which shares of our common stock having an aggregate offering price of up to $200.0 million may be offered and sold from time to time under the ATM Sales Agreement. No shares were sold under the ATM Sales Agreement during the nine months ended September 30, 2026.
Cash Flows
The following table summarizes our cash flows for each of the periods presented below (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Net cash used in operating activities |
|
$ |
(53,805 |
) |
|
$ |
(34,458 |
) |
|
$ |
(19,347 |
) |
Net cash used in investing activities |
|
|
(102,251 |
) |
|
|
(63,499 |
) |
|
|
(38,752 |
) |
Net cash provided by financing activities |
|
|
164,991 |
|
|
|
120,729 |
|
|
|
44,262 |
|
Net increase in cash and cash equivalents |
|
$ |
8,935 |
|
|
$ |
22,772 |
|
|
$ |
(13,837 |
) |
Operating Activities
During the nine months ended September 30, 2026, operating activities used $53.8 million of net cash, resulting from our net loss of $52.4 million and net changes in our operating assets and liabilities of $8.7 million, partially offset by net non-cash charges of $7.4 million. Changes in our operating assets and liabilities consisted of a $6.8 million increase in prepaid expenses and other current assets, a $2.2 million decrease in accounts payable and a $0.2 million increase in accrued expenses and other liabilities. The increase in prepaid expenses and other current assets was primarily due to an increase in deposits related to our clinical trial work performed by our CROs, prepayments related to our clinical trial work, an increase in accrued interest and dividends receivable from our higher invested cash equivalent and marketable securities balances, as well as an increase in prepayments on our corporate insurance policies. The decrease in accounts payable was primarily due to the timing of vendor invoices. The increase in accrued expenses and other liabilities was primarily due to an increase in accrued consulting and professional fees, partially offset by a decrease in accrued compensation and benefits. The non-cash charges consisted primarily of stock-based compensation expense of $8.8 million and a $0.3 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $1.9 million of accretion of our available-for-sale marketable securities.
During the nine months ended September 30, 2025, operating activities used $34.5 million of net cash, resulting from our net loss of $34.4 million and net changes in our operating assets and liabilities of $3.2 million, offset by net non-cash charges of $3.2 million. Changes in our operating assets and liabilities consisted of a $1.6 million increase in prepaid expenses and other current assets, a $0.9 million decrease in accrued expenses and other liabilities and a $0.7 million decrease in accounts payable. The increase in prepaid expenses and other current assets was primarily due to an increase in accrued interest and dividends receivable from our higher invested cash equivalent and marketable securities balance, as well as an increase in prepayments related to our clinical trial
22
work performed by our CROs and prepayments of our corporate insurance policies. The decrease in accrued expenses and other liabilities was primarily due to a decrease in accruals for clinical development and clinical trial work performed by our CROs and a decrease in accrued compensation and benefits. The decrease in accounts payable was primarily due to the timing of vendor invoices. The non-cash charges consisted primarily of stock-based compensation expense of $3.8 million and a $0.3 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $1.1 million of accretion of our available-for-sale marketable securities.
Investing Activities
During the nine months ended September 30, 2026, net cash used in investing activities was $102.3 million, primarily related to $209.5 million of purchases of available-for-sale marketable securities partially offset by $107.5 million of proceeds from maturities of available-for-sale marketable securities.
During the nine months ended September 30, 2025, net cash used in investing activities was $63.5 million, primarily related to $116.3 million of purchases of available-for-sale marketable securities partially offset by $52.8 million of proceeds from maturities of available-for-sale marketable securities.
Financing Activities
During the nine months ended September 30, 2026, net cash provided by financing activities was $165.0 million, primarily consisting of cash proceeds of $163.0 million, net of commissions from sales of our common stock in our April 2026 Offering and $2.4 million of cash proceeds from the exercise of stock options partially offset by $0.4 million in payments of offering costs related to the April 2026 Offering.
During the nine months ended September 30, 2025, net cash provided by financing activities was $120.7 million, primarily consisting of cash proceeds of $108.2 million, net of commissions from sales of our common stock in our June 2025 Offering, $10.8 million from the exercise of warrants, $1.9 million from the exercise of stock options and $0.7 million from the disgorgement of short-swing profits from a beneficial owner of our common stock, partially offset by $0.8 million in payments of offering costs related to the June 2025 and December 2024 Offerings.
Funding Requirements
We expect to incur substantial expenditures in the foreseeable future as we advance Haduvio through clinical development, the regulatory approval process and, if approved, commercial launch activities. Specifically, in the near term, we expect to incur substantial expenses relating to:
In addition, we may incur additional expenses:
We expect to continue to incur costs associated with operating as a public company, including significant legal, accounting, information technology, investor relations and other expenses.
We will need substantial additional funding to support our continuing operations. Until such time as we can generate significant revenue from sales of Haduvio, if ever, we expect to finance our operations through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms or at all. Our future funding requirements, both short-term and long-term, will depend on many factors, including:
23
We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into 2030. We expect these resources will enable us to fund our development program for Haduvio for the treatment of chronic cough in patients with IPF through potential U.S. FDA approval. We also expect that these cash resources will enable us to fund the clinical development program through Phase 2 for the treatment of patients with non-IPF ILD-related chronic cough, and our ongoing Phase 2b LAKE trial for the treatment of patients with RCC. However, our planned spending of these resources does not include any commercial expenses related to the commercial launch of Haduvio or any expenses related to Phase 3 clinical trials in non-IPF ILD-related chronic cough and RCC. In addition, these resources will not be sufficient for us to fund the clinical development of Haduvio through regulatory approval for non-IPF ILD-related chronic cough or RCC, or to fund any future product candidates through regulatory approval, and we will need to raise substantial additional capital to complete the development and commercialization of Haduvio and any future product candidates.
We have based our estimates as to how long we expect we will be able to fund our operations and the timing and costs of our planned trials and regulatory process on assumptions that may prove to be wrong and we could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing, and our trials and regulatory activities may be delayed or take longer than we currently expect. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy.
We do not have any committed external source of funds. Accordingly, we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations, licensing arrangements or other sources to complete the clinical development and commercialization of Haduvio for the treatment of chronic cough in patients with IPF, non-IPF ILD or RCC or any other indication. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any debt financing into which we enter would result in fixed payment obligations and may involve agreements that include grants of security interests on our assets and restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, granting liens over our assets, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates. Any debt financing that we seek or additional equity that we raise may contain terms that could adversely affect our common stockholders.
If we are unable to raise sufficient capital as and when needed, we may be required to delay, reduce or abandon our product development programs or commercialization efforts. If we raise additional funds through collaborations or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.
Contractual Obligations and Commitments
A significant portion of our development activities are outsourced to third parties under agreements, including with CROs and contract manufacturers in connection with the production of clinical trial materials. The contracts are cancelable at any time by us, generally upon 45 to 60 days’ prior written notice to the CRO, and therefore we believe that our non-cancelable obligations under
24
these agreements are not material. For information related to our future commitments relating to our lease and licensing agreements, refer to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025.
Critical Accounting Policies and Use of Estimates
Our Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these Condensed Consolidated Financial Statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the Condensed Consolidated Financial Statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in the Notes to our financial statements, we believe that the critical accounting policy related to research and development expenses that is described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2025, is the most important to understanding and evaluating our reported financial results. During the nine months ended September 30, 2026, there were no material changes to our critical accounting policies.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not Applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2026. Our disclosure controls and procedures are designed to ensure that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures, and is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls and procedures can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. Based on the evaluation of our disclosure controls and procedures as of September 30, 2026, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended September 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not subject to any material legal proceedings.
Item 1A. Risk Factors.
Our business is subject to numerous risks. The following important factors, among others, could cause our actual results to differ materially from those expressed in forward-looking statements made by us or on our behalf in this Quarterly Report on Form 10-Q and other filings with the SEC, press releases, communications with investors and oral statements. Actual future results may differ materially from those anticipated in our forward-looking statements. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Our risk factors have not changed materially from those described in "Part I, Item 1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2025, except for the risk factors noted below.
We face competition, which may result in others developing or commercializing products before or more successfully than we do.
The development and commercialization of new products is highly competitive. We expect that we will face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to Haduvio or any future product candidate that we may seek to develop or commercialize. Our competitors may succeed in developing, acquiring or licensing technologies and products that are more effective, have fewer or more tolerable side effects or are more convenient or less costly than Haduvio or any future product candidate we may develop, which could render any product candidates
25
obsolete and noncompetitive. Our competitors also may obtain FDA or other marketing approval for their products before we are able to obtain approval for ours, which could result in competitors establishing a strong market position before we are able to enter the applicable market.
If Haduvio is approved for the treatment of chronic cough in patients with IPF and non-IPF ILD, we expect that it may compete with product candidates that in the future may be developed for the treatment of chronic cough in patients with IPF or ILD. It is possible that product candidates currently in development for the treatment of fibrosis in patients with IPF and ILD could, if approved, reduce the need for therapies to treat chronic cough in patients with IPF and non-IPF ILD. We expect that Haduvio might also compete with other product candidates developed in the future, for the treatment of patients with RCC that might be used off-label to treat IPF-related chronic cough.
If Haduvio is approved for the treatment of patients with RCC, we expect that it may compete with product candidates in clinical development for the treatment of patients with RCC. Gefapixant, a P2X3 antagonist, which was developed by Merck & Co., Inc., or Merck, is approved for refractory or unexplained chronic cough in Japan, the United Kingdom, Switzerland, and the E.U. The application filed with the FDA was withdrawn and Merck indicated it does not plan to refile. Camlipixant, a P2X3 antagonist, which was being developed by GSK plc., failed its Phase 3 program and GSK plc announced it would not progress further with development in RCC as of July 2026.
We also expect that Haduvio would compete with a number of therapeutics that are not specifically approved to treat chronic cough including benzonatate, opioids, corticosteroids, proton-pump inhibitors, and neuromodulators.
Many of our competitors and potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and commercializing approved products than we do. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials.
We are currently eligible to use the scaled disclosure accommodations available to “smaller reporting companies”, and our use of such scaled disclosure accommodations may make our common stock less attractive to investors.
We are currently eligible to use the scaled disclosure accommodations available to “smaller reporting companies.” These scaled disclosure accommodations include simplified executive compensation disclosure and certain other decreased disclosure obligations in SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. As of June 30, 2026, the last business day of our most recently completed second fiscal quarter, the market value of our common stock held by non-affiliates exceeded $700.0 million. As a result, we will no longer be able to use these scaled disclosure accommodations available to smaller reporting companies beginning with our Quarterly Report on Form 10-Q for the first quarter of fiscal year 2027, however we may, and we expect that we will, continue to take advantage of these scaled disclosure accommodations for the remainder of fiscal year 2026, including in our Annual Report on Form 10-K for the fiscal year ending December 31, 2026. Our use of such scaled disclosure accommodations in our SEC filings may make it harder for investors to analyze our results of operations and financial prospects and may make our common stock less attractive to investors.
Item 5. Other Information.
(c) Director and Officer Trading Arrangements
During the three months ended September 30, 2026,
None of our other directors or officers
26
Item 6. Exhibits.
Exhibit Number |
|
Description |
|
|
|
31.1* |
|
|
|
|
|
31.2* |
|
|
|
|
|
32.1** |
|
|
|
|
|
32.2** |
|
|
|
|
|
101.INS* |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
|
|
|
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents. |
|
|
|
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* Filed herewith.
** Furnished herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
TREVI THERAPEUTICS, INC. |
|
|
|
|
|
Date: November 9, 2026 |
|
By: |
/s/ Jennifer L. Good |
|
|
|
Jennifer L. Good President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ David C. Hastings |
|
|
|
David C. Hastings Chief Financial Officer (Principal Financial Officer) |
|
|
|
|
28
Exhibit 31.1
CERTIFICATION PURSUANT TO RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jennifer L. Good, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Trevi Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
Date: November 9, 2026 |
|
|
By: |
|
/s/ Jennifer L. Good |
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Jennifer L. Good |
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President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David C. Hastings, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Trevi Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: November 9, 2026 |
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By: |
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/s/ David C. Hastings |
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David C. Hastings |
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Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Trevi Therapeutics, Inc. (the “Company”) for the period ended September 30, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Jennifer L. Good, President and Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to her knowledge:
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Date: November 9, 2026 |
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By: |
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/s/ Jennifer L. Good |
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Jennifer L. Good |
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President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Trevi Therapeutics, Inc. (the “Company”) for the period ended September 30, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, David C. Hastings, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
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Date: November 9, 2026 |
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By: |
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/s/ David C. Hastings |
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David C. Hastings |
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Chief Financial Officer (Principal Financial Officer) |