Trevi Therapeutics, Inc.

Previous wording

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 plan to conduct the Phase 3 trials in parallel, with the first Phase 3 trial to be initiated in the second quarter of 2026 and the second Phase 3 trial to be initiated in the second half of 2026. The two Phase 3 trials will be conducted as randomized, double-blind, placebo-controlled, multicenter global trials with 2:1 randomization. The protocol for the first of the two Phase 3 trials 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 endpoint measured at 52 weeks of fixed dosing. The protocol for the second of the two Phase 3 trials provides for the enrollment of approximately 200 patients and 12 weeks of fixed dosing with Haduvio 54 mg BID with the primary efficacy endpoint measured at 12 weeks of fixed dosing. The primary efficacy endpoint for both trials 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 with placebo. A key secondary endpoint for both trials will be relative change from Baseline in the cough severity numerical rating scale (CS-NRS). These trial designs are subject to final review of the protocols by the FDA. We expect to have topline results from the first Phase 3 trial in the first half of 2028 and from the second Phase 3 trial in the second half of 2027.

Current wording

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 plan to initiate our Phase 3 OCEAN-2 trial in the third quarter of 2026. The two Phase 3 trials will be 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 at 52 weeks of fixed dosing. The protocol for the Phase 3 OCEAN-2 trial provides for the enrollment of approximately 200 patients and 12 weeks of fixed dosing with Haduvio 54 mg BID with the primary efficacy endpoint measured at 12 weeks of fixed dosing. 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 (CS-NRS). These trials are subject to review of the protocols by regulatory authorities. 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.

Previous wording

Non-IPF ILD-related Chronic Cough Program. We are also developing Haduvio for the treatment of non-IPF ILD-related chronic cough. We plan to initiate an adaptive design Phase 2b clinical trial for the treatment of patients with non-IPF ILD-related chronic cough in the second half of 2026, subject to a meeting with the FDA and review of the trial protocol by the FDA. If we initiate the trial when anticipated, we would expect topline results from the Phase 2b trial in the second half of 2027.

Current wording

Non-IPF ILD-related Chronic Cough Program. We are also developing Haduvio for the treatment of non-IPF ILD-related chronic cough. We plan to initiate an adaptive design Phase 2b clinical trial for the treatment of patients with non-IPF ILD-related chronic cough in the second half of 2026, subject to a meeting with the FDA and review of the trial protocol by the FDA. We recently submitted a meeting request to the FDA. If we initiate the trial when anticipated, we would expect topline results from the Phase 2b trial in the second half of 2027.

Previous wording

We expect to initiate a Phase 2b trial of Haduvio for the treatment of patients with RCC in the second quarter of 2026. We are planning to conduct this randomized, double-blind, placebo-controlled, multicenter trial in the United Kingdom, Canada, and Poland. The Phase 2b trial will enroll approximately 100 patients. The Phase 2b trial is designed to evaluate three different dose groups of Haduvio (54 mg BID, 27 mg BID, and 27 mg once daily (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 trial is subject to review of the protocol by regulatory authorities. The protocol will provide for a sample size re-estimation, or SSRE, analysis, which is expected to occur in the fourth quarter of 2026 and topline results for the clinical trial expected to occur in the second half of 2027.

Current wording

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 Phase 2b LAKE trial will enroll approximately 100 patients. The Phase 2b LAKE trial is designed to evaluate three different dose groups of Haduvio (54 mg BID, 27 mg BID, and 27 mg once daily (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, which is expected to occur in the fourth quarter of 2026. We will report the outcome of the SSRE once available and expect to report topline results from the trial in the second half of 2027.

Previous wording

Other NDA Supportive Studies. We also plan to continue to progress and advance NDA supportive studies necessary for regulatory approval, including Phase 1 clinical studies such as completing our respiratory safety study, and conducting drug-drug interaction, food effect, and hepatic and renal impairment studies.

Current wording

Other NDA Supportive Studies. We also plan to continue to progress and advance NDA supportive studies necessary for regulatory approval, including Phase 1 clinical studies such as conducting drug-drug interaction, food effect, and hepatic and renal impairment studies. We have completed the clinical portion of our respiratory safety study.

Previous wording

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 March 31, 2026, we had an accumulated deficit of $343.0 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.

Current wording

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 June 30, 2026, we had an accumulated deficit of $360.8 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.

Previous wording

As of March 31, 2026, we had cash, cash equivalents and marketable securities of $171.8 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.

Current wording

As of June 30, 2026, we had cash, cash equivalents and marketable securities of $318.9 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.

Previous wording

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 planned Phase 3 trials for the treatment of IPF-related chronic cough, our planned adaptive design Phase 2b clinical trial of Haduvio for the treatment of non-IPF ILD-related chronic cough, our planned Phase 2b clinical trial of Haduvio for the treatment of patients with RCC, and our ongoing and planned Phase 1 NDA supportive studies.

Current wording

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 trial and our planned Phase 3 OCEAN-2 trial, each for the treatment of IPF-related chronic cough, our planned adaptive design Phase 2b clinical trial of Haduvio for the treatment of non-IPF ILD-related chronic cough, our ongoing Phase 2b LAKE clinical trial of Haduvio for the treatment of patients with RCC, and our ongoing and planned Phase 1 NDA supportive studies.

Previous wording

Other income (expense), net consists of foreign currency transaction gains and losses.

Current wording

Other (expense) income, net consists of foreign currency transaction gains and losses.

Previous wording

Research and development expenses for the three months ended March 31, 2026 increased to $9.9 million from $7.8 million for the corresponding period in 2025, primarily due to increased clinical development expenses for our Phase 1 NDA supportive studies, Phase 3 IPF-related chronic cough trials and Phase 2b RCC trial, partially offset by a decrease in clinical development expenses for our Phase 2b CORAL trial and Phase 2a RIVER trial.

Current wording

Research and development expenses for the three months ended June 30, 2026 increased to $15.2 million from $9.4 million for the corresponding period in 2025, primarily due to increased clinical development expenses due to our Phase 3 OCEAN-1 trial, our Phase 2b LAKE trial, our Phase 3 OCEAN-2 trial and our Phase 1 NDA supportive studies, as well as increases in stock-based compensation and personnel-related expenses. These increases were partially offset by decreased costs for our Phase 2b CORAL trial.

Previous wording

Other income, net for the three months ended March 31, 2026 increased to $1.7 million from $1.1 million for the corresponding period in 2025, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.

Current wording

Other income, net for the three months ended June 30, 2026 was $2.7 million compared to $1.4 million for the corresponding period in 2025. The change was primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.

Previous wording

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 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 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Current wording

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 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.

Previous wording

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 three months ended March 31, 2026.

Current wording

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 six months ended June 30, 2026.

Previous wording

During the three months ended March 31, 2026, operating activities used $16.7 million of net cash, resulting from our net loss of $13.2 million and net changes in our operating assets and liabilities of $5.4 million, partially offset by net non-cash charges of $1.9 million. Changes in our operating assets and liabilities consisted of $2.8 million increase in prepaid expenses and other current assets, a $1.5 million decrease in accounts payable, and a $1.1 million decrease in accrued expenses and other liabilities. The increase in prepaid expenses and other current assets was primarily due to an increase in deposits and prepayments related to our clinical trial work performed by our CROs, as well as an increase in interest and dividends receivable from our higher invested cash equivalent and marketable securities balances. The decrease in accounts payable was primarily due to the timing of vendor invoices. The decrease in accrued expenses and other liabilities was primarily due to a decrease in accrued compensation and benefits. The non-cash charges consisted primarily of stock-based compensation expense of $2.2 million, partially offset by $0.4 million of accretion of our available-for-sale marketable securities.

Current wording

During the six months ended June 30, 2026, operating activities used $34.1 million of net cash, resulting from our net loss of $31.0 million and net changes in our operating assets and liabilities of $7.9 million, partially offset by net non-cash charges of $4.8 million. Changes in our operating assets and liabilities consisted of a $5.8 million increase in prepaid expenses and other current assets, a $1.8 million decrease in accounts payable and a $0.4 million decrease 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 prepayments on our corporate insurance policies, as well as an increase in accrued interest and dividends receivable from our higher invested cash equivalent and marketable securities balances. The decrease in accounts payable was primarily due to the timing of vendor invoices. The decrease in accrued expenses and other liabilities was primarily due to a decrease in accrued compensation and benefits. The non-cash charges consisted primarily of stock-based compensation expense of $5.5 million and a $0.2 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $1.0 million of accretion of our available-for-sale marketable securities.

Previous wording

During the three months ended March 31, 2025, operating activities used $13.5 million of net cash, resulting from our net loss of $10.3 million and net changes in our operating assets and liabilities of $4.1 million, partially offset by net non-cash charges of $1.0 million. Changes in our operating assets and liabilities consisted of a $2.0 million decrease in accounts payable, a $1.5 million decrease in accrued expenses and other liabilities and a $0.6 million increase in prepaid expenses and other current assets. The decrease in accounts payable was primarily due to the timing of vendor invoices. The decrease in accrued expenses and other liabilities was primarily due to a decrease in accrued compensation and benefits along with a decrease in accruals for clinical development and clinical trial work performed by our CROs. The increase in prepaid expenses and other current assets was primarily due to an increase in prepayments related to our clinical trial work performed by our CROs. The non-cash charges consisted primarily of stock-based compensation expense of $1.2 million, $0.1 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $0.4 million of accretion of our available-for-sale marketable securities.

Current wording

During the six months ended June 30, 2025, operating activities used $23.6 million of net cash, resulting from our net loss of $22.6 million and net changes in our operating assets and liabilities of $3.1 million, partially offset by net non-cash charges of $2.1 million. Changes in our operating assets and liabilities consisted of a $1.6 million increase in prepaid expenses and other current assets, a $1.0 million decrease in accrued expenses and other liabilities and a $0.4 million decrease in accounts payable. The increase in prepaid expenses and other current assets was primarily due to an increase in prepayments related to our clinical trial work performed by our CROs as well as an increase in prepayments of our corporate insurance policies. The decrease in accrued expenses and other liabilities was primarily due to a decrease in accrued compensation and benefits along with a decrease in accruals for clinical development and clinical trial work performed by our CROs. 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 $2.6 million and a $0.2 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $0.8 million of accretion of our available-for-sale marketable securities.

Previous wording

During the three months ended March 31, 2025, net cash used in investing activities was $10.0 million, primarily related to $27.5 million of purchases of available-for-sale marketable securities partially offset by $17.6 million of proceeds from maturities of available-for-sale marketable securities.

Current wording

During the six months ended June 30, 2026, net cash used in investing activities was $95.1 million, primarily related to $162.1 million of purchases of available-for-sale marketable securities partially offset by $67.2 million of proceeds from maturities of available-for-sale marketable securities.

Previous wording

During the three months ended March 31, 2026, net cash provided by investing activities was $17.0 million, primarily related to $25.6 million of proceeds from maturities of available-for-sale marketable securities partially offset by $8.5 million of purchases of available-for-sale marketable securities.

Current wording

During the six months ended June 30, 2025, net cash used in investing activities was $12.6 million, primarily related to $44.7 million of purchases of available-for-sale marketable securities partially offset by $32.1 million of proceeds from maturities of available-for-sale marketable securities.

Previous wording

During the three months ended March 31, 2025, net cash provided by financing activities was $8.7 million, primarily consisting of cash proceeds of $8.2 million from the exercise of warrants and $0.7 million of cash proceeds from the exercise of stock options partially offset by $0.2 million in payments of offering costs related to the December 2024 Offering.

Current wording

During the six months ended June 30, 2025, net cash provided by financing activities was $119.1 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 and $0.7 million of cash proceeds from the exercise of stock options partially offset by $0.6 million in payments of offering costs related to the June 2025 and December 2024 Offerings.

Previous wording

the scope, progress, timing, costs and results of clinical trials of Haduvio, including our planned Phase 3 trials of Haduvio for the treatment of IPF-related chronic cough, our planned adaptive design Phase 2b clinical trial of Haduvio for the treatment of non-IPF ILD-related chronic cough, our planned Phase 2b clinical trial for the treatment of RCC, and our planned Phase 1 NDA supportive studies, as well as trials for any future product candidates and the costs of seeking regulatory approvals;

Current wording

the scope, progress, timing, costs and results of clinical trials of Haduvio, including our ongoing Phase 3 OCEAN-1 trial and planned Phase 3 OCEAN-2 trial of Haduvio, each for the treatment of IPF-related chronic cough, our planned adaptive design Phase 2b clinical trial of Haduvio for the treatment of non-IPF ILD-related chronic cough, our ongoing Phase 2b LAKE clinical trial for the treatment of RCC, and our ongoing and planned Phase 1 NDA supportive studies, as well as trials for any future product candidates and the costs of seeking regulatory approvals;

Previous wording

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, including our two planned Phase 3 trials, potentially through U.S. FDA approval. We also expect that these cash resources will enable us to fund and report topline data from our planned Phase 2b clinical trial and potentially a subsequent Phase 3 clinical trial for the treatment of patients with non-IPF ILD, and our planned Phase 2b 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 the conduct of any other clinical trials. 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.

Current wording

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, including our ongoing Phase 3 OCEAN-1 trial and planned Phase 3 OCEAN-2 trial, through potential U.S. FDA approval. We also expect that these cash resources will enable us to fund the clinical development program through Phase 3 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 a Phase 3 clinical trial in 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.

Previous wording

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 three months ended March 31, 2026, there were no material changes to our critical accounting policies.

Current wording

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 six months ended June 30, 2026, there were no material changes to our critical accounting policies.