Trevi Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
TRVI$15.31+6.8%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-338023
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001193125-26-453674
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 94 previous paragraphs and 95 current paragraphs.
64 unchanged; 27 reworded; 4 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
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.
Current report
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.
Current report
our ongoing Phase 3 OCEAN-1 and OCEAN-2 trials and any additional trials of Haduvio for the treatment of IPF-related chronic cough;
Current report
our planned Phase 2 dose-ranging trial and any additional trials of Haduvio for the treatment of non-IPF ILD-related chronic cough;
Removed paragraphs (3)
Previous report
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 report
our ongoing Phase 3 OCEAN-1 trial and planned Phase 3 OCEAN-2 trial and any additional trials of Haduvio for the treatment of IPF-related chronic cough;
Previous report
our planned adaptive design Phase 2b clinical trial and any additional trials of Haduvio for the treatment of non-IPF ILD-related chronic cough;
Reworded paragraphs (27)
Previous wording
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 acts on the cough reflex arc both centrally and peripherally as akappa receptora gonist and amu receptora ntagonist, or KAMA, targeting opioid receptors that play a key role in controlling chronic cough. The kappa- and mu-opioid receptors are found in respiratory-related regions of the brainstem and spinal cord, as well as higher brain regions. Nalbuphine has been approved and marketed as an injectable for pain indications for decades in the United States, or the U.S., and Europe. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with mu-opioid agonists because it antagonizes, or blocks, the mu-opioid receptor. Parenteral nalbuphine is not scheduled as a controlled substance by the U.S. Drug Enforcement Agency and in most of Europe.
Current wording
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 actingk appa opioid receptora gonist and amu opioid receptora ntagonist, 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.
Previous wording
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 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 twice-a-day, or 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%.
Current wording
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%.
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 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.
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 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 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.
Previous 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.
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 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.
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 conducting drug-drug interaction, food effect, and hepatic and renal impairment studies. We have completed the clinical portion of our respiratory safety study.
Current wording
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.
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 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.
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 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.
Previous 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.
Current wording
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.
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 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.
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 and OCEAN-2 trials, each for the treatment of IPF-related chronic cough, our planned Phase 2 dose-ranging 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, including the planned SSRE and our ongoing and planned Phase 1 NDA supportive studies.
Previous 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.
Current wording
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.
Previous wording
General and administrative expenses for the three months ended June 30, 2026 increased to $5.4 million from $4.3 million for the corresponding period in 2025, primarily due to an increase in stock-based compensation and personnel-related expenses, partially offset by decreased outside services and professional fees.
Current wording
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.
Previous 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.
Current wording
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.
Previous wording
Comparison of the Six Months Ended June 30, 2026 and 2025
Current wording
Comparison of the Nine Months Ended September 30, 2026 and 2025
Previous wording
Research and development expenses for the six months ended June 30, 2026 increased to $25.1 million from $17.2 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 and Phase 2a RIVER trial.
Current wording
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.
Previous wording
General and administrative expenses for the six months ended June 30, 2026 increased to $10.3 million from $8.0 million for the corresponding period in 2025, primarily due to an increase in stock-based compensation and personnel-related expenses.
Current wording
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.
Previous wording
Other income, net for the six months ended June 30, 2026 was $4.4 million compared to $2.5 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.
Current wording
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.
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 six months ended June 30, 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 nine months ended September 30, 2026.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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 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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous wording
During the six months ended June 30, 2026, net cash provided by financing activities was $164.6 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 $1.9 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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;
Current wording
the scope, progress, timing, costs and results of clinical trials of Haduvio, including our ongoing Phase 3 OCEAN-1 and OCEAN-2 trials of Haduvio, each for the treatment of IPF-related chronic cough, our planned Phase 2 dose-ranging 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
the costs of commercialization activities for Haduvio for the treatment of IPF-related chronic cough, non-IPF ILD and RCC or for any future product candidates that receive marketing approval, if any, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
Current wording
the costs of commercialization activities for Haduvio for the treatment of IPF-related chronic cough, non-IPF ILD-related chronic cough and RCC or for any future product candidates that receive marketing approval, if any, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
Previous wording
our headcount growth and associated costs as we expand our research and development activities and medical affairs activities and establish a commercial infrastructure;
Current wording
our headcount growth and associated costs as we expand our research and development and medical affairs activities and establish a commercial infrastructure;
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 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.
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 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.
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 six months ended June 30, 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 nine months ended September 30, 2026, there were no material changes to our critical accounting policies.