Trevi Therapeutics, Inc.

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 idiopathic pulmonary fibrosis, or IPF, 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 a kappa agonist and a mu antagonist (KAMA). Kappa and mu are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is a mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 30 years 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 in the U.S. and 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, chronic cough in patients with non-IPF interstitial lung disease or non-IPF ILD, and in patients with 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 a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. The kappa- and mu-opioid receptors are known to be critical mediators of cough. Nalbuphine is a mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 30 years in the United States, or the U.S., and Europe. Nalbuphine’s mechanism of action also potentially 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 in the U.S. and most of Europe.

Previous wording

IPF Program. In September 2022, we announced positive data from the full set of patients in our Phase 2 clinical trial of Haduvio for the treatment of chronic cough in IPF, which we refer to as the Phase 2 CANAL trial. The Phase 2 CANAL 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 chronic cough in IPF that we conducted at multiple sites in the United Kingdom. In total, 42 patients in the study received Haduvio. In the Phase 2 CANAL trial, Haduvio demonstrated statistically significant results for the primary efficacy endpoint of daytime cough frequency reduction (p<0.0001) and for key secondary endpoints on patient and clinician reported outcomes. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials in other patient populations.

Current wording

Chronic Cough in Patients with IPF Program. We previously announced positive data from the full set of patients in our Phase 2 clinical trial of Haduvio for the treatment of chronic cough in patients with IPF, which we refer to as the Phase 2 CANAL trial. The Phase 2 CANAL 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 chronic cough in patients with IPF that we conducted at multiple sites in the United Kingdom. In total, 42 patients in the study received Haduvio. In the Phase 2 CANAL trial, Haduvio demonstrated statistically significant results for the primary efficacy endpoint of daytime cough frequency reduction (p<0.0001) and for key secondary endpoints on patient and clinician reported outcomes. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials in other patient populations.

Previous wording

We are conducting our Phase 2b CORAL clinical trial, which is a dose-ranging study evaluating the efficacy, safety and tolerability of Haduvio for chronic cough in IPF. This trial is being conducted at multiple sites in ten countries and uses a randomized, double-blind, placebo-controlled, parallel-arm design, which evaluates three doses of Haduvio over six weeks as compared to placebo. The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of week six versus baseline for Haduvio compared to placebo, as measured via an objective cough monitor. We expect the trial to enroll approximately 160 patients. The protocol for the Phase 2b CORAL clinical trial provides for a sample size re-estimation, or SSRE, analysis once approximately 50% of the patients in the trial are evaluable for the primary endpoint. In October 2024, we reached 50% of the targeted study enrollment. As a result, we expect the SSRE analysis will be performed once the last of these patients completes the six weeks of treatment and is evaluable for the primary endpoint. The outcome of the SSRE analysis is expected in December 2024 and is expected to result in the recommendation to: maintain the current targeted sample size of 160 patients, upsize the targeted sample size within a pre-specified range, or evaluate for futility. Assuming no adjustments are made to the sample size, we expect to report topline results in the first half of 2025.

Current wording

We are conducting our Phase 2b CORAL clinical trial, which is a dose-ranging study evaluating the efficacy, safety and tolerability of Haduvio for chronic cough in patients with IPF. This trial is being conducted at multiple sites in ten countries and uses a randomized, double-blind, placebo-controlled, parallel-arm design, which evaluates three doses of Haduvio as compared to placebo. The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of week six versus baseline for Haduvio compared to placebo, as measured via an objective cough monitor. The protocol for the Phase 2b CORAL clinical trial provided for a sample size re-estimation, or SSRE, analysis once approximately 50% of the patients in the trial were evaluable for the primary endpoint. In October 2024, we reached 50% of the targeted study enrollment. As a result, the SSRE analysis was performed once the last of these patients completed the six weeks of treatment and was evaluable for the primary endpoint. In December 2024, we announced that this analysis resulted in no change to the targeted 160 patient sample size for the trial, confirming the pre-specified conditional power of 80% or greater. We completed enrollment of the trial in February 2025 and last patient last visit for the trial was completed in April 2025. We expect to announce topline results in the second quarter of 2025. Subject to the results of the Phase 2b CORAL clinical trial, we expect to request an end of Phase 2 meeting with the FDA in 2025 and initiate our Phase 3 program for Haduvio for chronic cough in patients with IPF in the first half of 2026.

Previous wording

We are also conducting a Phase 1b respiratory physiology study, which we refer to as TIDAL, in the United Kingdom and U.S. and we have initiated screening. The study will evaluate the effect of Haduvio on respiratory physiology in patients with IPF of varying disease severity. TIDAL is a randomized, single-blind, placebo-controlled study. We expect to enroll up to approximately 25 patients who will be in-patient for ten days. The primary endpoint of the study is the effect of escalating doses of Haduvio on respiratory function, as measured by minute ventilation. Secondary endpoints of additional respiratory functions will also be measured. The goal of this study is to define the patient population for any Phase 3 studies that we may conduct in chronic cough in IPF.

Current wording

We are also conducting a Phase 1 respiratory function and safety study, which we refer to as TIDAL, in the U.K. and U.S. and we have initiated screening. TIDAL is a multi-center, open-label, in-clinic, fixed-sequence placebo and NAL ER dose escalation study assessing overnight respiratory function and safety in patients with IPF. We expect to enroll up to approximately 10 patients who will be in-clinic for ten days. The goal of the study is to assess the safety and tolerability of Haduvio as well as the effect on respiratory function and safety in subjects with IPF based on assessment of end tidal partial pressure of carbon dioxide (PetCO2), oxygen saturation (SpO2), and respiratory rate. We plan to use this information to define the patient population for any Phase 3 clinical trials that we may conduct in chronic cough in patients with IPF.

Previous wording

RCC Program. We are also developing Haduvio for the treatment of RCC. We are conducting a Phase 2a clinical trial of Haduvio for RCC, which we refer to as the Phase 2a RIVER trial. The Phase 2a RIVER trial is a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study that is designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for the treatment of RCC. We are conducting this trial at multiple sites in the United Kingdom and Canada. The primary endpoint of the trial is a mean change in 24-hour cough frequency in the overall population as determined using an objective cough monitor. Based on the screening results, the trial enrolled patients into one of two subgroups: 10-19 coughs/hour (moderate 24-hour cough frequency) and ≥20 coughs/hour (high 24-hour cough frequency). The trial will explore secondary endpoints, including patient reported outcome measures for cough frequency and severity. The trial was designed to enroll approximately 60 adult patients. In October 2024, we announced that we had completed enrollment of this trial. We expect to report topline efficacy and safety data in the first quarter of 2025.

Current wording

RCC Program. We are also developing Haduvio for the treatment of patients with RCC. In March 2025, we announced positive topline data from our Phase 2a clinical trial of Haduvio in 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. We conducted this trial at multiple sites in the United Kingdom and Canada. In total, 66 patients in the trial received Haduvio. 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 at Day 21. The full analysis set population included all patients who received at least one dose of study drug and have objective cough count data on both Baseline and Day 21 in at least one treatment period (N=59). In the trial, Haduvio met the primary endpoint with a statistically significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% 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. Haduvio demonstrated a statistically significant reduction for the secondary endpoint of reduction in 24-hour cough frequency in two pre-specified subgroups: patients who coughed 10-19 times/hour (moderate 24-hour cough frequency) (p<0.0001), and patients who coughed 20 or greater times/hour (severe 24-hour cough frequency) (p<0.0001). 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.

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 September 30, 2024, we had an accumulated deficit of $275.6 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 IPF and RCC or for the treatment of prurigo nodularis 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 March 31, 2025, we had an accumulated deficit of $297.4 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, chronic cough in patients with non-IPF ILD, or in patients with RCC and we can provide no assurance that we will ever generate significant revenue or profits.

Previous wording

As of September 30, 2024, we had cash, cash equivalents and marketable securities of $65.5 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 March 31, 2025, we had cash, cash equivalents and marketable securities of $103.3 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 Phase 2b CORAL clinical trial for the treatment of chronic cough in IPF, our Phase 2a RIVER clinical trial of Haduvio for the treatment of RCC, our Phase 1b TIDAL respiratory physiology study in patients with IPF of varying disease severity and our HAP study to compare the abuse potential of oral nalbuphine to IV butorphanol.

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 2b CORAL clinical trial and our planned Phase 3 program for the treatment of chronic cough in patients with IPF, our ongoing Phase 1 TIDAL respiratory function and safety study in patients with IPF of varying disease severity, our planned Phase 2a clinical trial of Haduvio for the treatment of chronic cough in patients with non-IPF ILD, our next clinical trial of Haduvio for the treatment of patients with RCC, and any supportive studies necessary for regulatory approval.

Previous wording

We will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as 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.

Current wording

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.

Previous wording

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, contract manufacturing costs and fees paid to contract research organizations, or CROs, to conduct certain research and development activities on our behalf. 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.

Current wording

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.

Previous wording

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, consulting and accounting services; as well as rent and other general operating expenses not otherwise classified as research and development expenses.

Current wording

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.

Previous wording

Other income, net consists of foreign currency transaction gains and losses as well as employee retention tax credit under the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act as well as an immaterial effect from the early extinguishment of debt in connection with us paying the remaining amounts due under the SVB Loan Agreement..

Current wording

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

Previous wording

Interest expense consists of the interest expense associated with our finance lease. In 2023, interest expense also included interest under the SVB Loan Agreement pursuant to which we borrowed $14.0 million under the SVB Term Loan. In connection with the SVB Term Loan, we recognized interest expense which included amortization of deferred financing charges, accretion of loan discount-financing costs, accrual of the final payment fee, amortization of the term loan discount-interest and the stated interest on the SVB Term Loan.

Current wording

Interest expense consists of the interest expense associated with our finance lease.

Previous wording

Research and development expenses for the three months ended September 30, 2024 increased to $11.2 million from $6.3 million for the corresponding period in 2023, primarily due to increased clinical development expenses for our Phase 2b CORAL trial, our Phase 2a RIVER trial, and our HAP study as well as an increase in personnel related expenses.

Current wording

Research and development expenses for the three months ended March 31, 2025 decreased to $7.8 million from $8.8 million for the corresponding period in 2024, primarily due to decreased clinical development expenses for our HAP study, which was actively enrolling patients in the prior year period, partially offset by an increase in personnel related expenses due to increased headcount along with a corresponding increase in stock-based compensation expense.

Previous wording

General and administrative expenses for the three months ended September 30, 2024 increased to $2.9 million from $2.7 million for the corresponding period in 2023, primarily due to an increase in stock-based compensation expense.

Current wording

General and administrative expenses for the three months ended March 31, 2025 increased to $3.7 million from $3.1 million for the corresponding period in 2024, primarily due to an increase in stock-based compensation expense and personnel related expenses.

Previous wording

Other income, net for the three months ended September 30, 2024 was $0.8 million compared to other income, net of $1.3 million for the corresponding period in 2023. The change was primarily due to a decrease in interest income due to lower cash equivalent and marketable securities balances.

Current wording

Other income, net for the three months ended March 31, 2025 was $1.1 million compared to other income, net of $1.0 million for the corresponding period in 2024. The change was primarily due to an increase in interest income due to higher average cash equivalent and marketable securities balances.

Previous wording

Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. Prior to the completion of our IPO and concurrent private placement in May 2019, we financed our operations primarily through private placements of our preferred stock and convertible notes as well as borrowings under our prior term loan. From inception to our IPO, we raised an aggregate of $102.2 million in gross proceeds from sales of our preferred stock and convertible notes and borrowed $15.0 million under a prior term loan.

Current wording

Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations.

Previous wording

In June 2023, we filed with the SEC a universal shelf registration statement on Form S-3, or the Shelf Registration Statement, which allows 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 Shelf Registration Statement was filed to replace our prior universal shelf registration statement on Form S-3 and was declared effective on August 15, 2023. Further, in June 2023, we entered into a new sales agreement with Leerink Partners, LLC (formerly SVB Securities), or Leerink Partners, which we refer to as the 2023 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 2023 ATM Sales Agreement. We filed a prospectus under the 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 2023 ATM Sales Agreement. In accordance with the terms of the 2023 ATM Sales Agreement, the ATM Sales Agreement terminated upon effectiveness of the Shelf Registration Statement, at which point we were no longer able to issue and sell shares of our common stock under the ATM Sales Agreement. As of September 30, 2024, we had issued and sold 3,086,729 shares of common stock for gross proceeds of $10.0 million, before deducting estimated commissions and allocated fees of $0.3 million under the 2023 ATM Sales Agreement. Subsequent to September 30, 2024, and through October 31, 2024, we issued and sold 1,411,336 shares of common stock for gross proceeds of $4.6 million, before deducting estimated commissions and allocated fees of $0.1 million under the 2023 ATM Sales Agreement.

Current wording

In June 2020, we entered into a sales agreement, or the 2020 ATM Sales Agreement, with SVB Securities LLC, or SVB Securities, under which we were able to issue and sell shares of common stock, from time to time, having an aggregate offering price of up to $12.0 million. In May 2022, we and SVB Securities amended the 2020 ATM Sales Agreement to increase the maximum aggregate offering price of common stock that we were able to issue and sell from time to time under the 2020 ATM Sales Agreement by $50.0 million, from $12.0 million to up to $62.0 million. Sales of common stock under the 2020 ATM Sales Agreement were able to be made by any method that was deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act. We were not obligated to make any sales of our common stock under the 2020 ATM Sales Agreement. Through August 15, 2023, the date of termination of the 2020 ATM Sales Agreement, we had issued and sold an aggregate of 4,333,394 shares of common stock for gross proceeds of $12.7 million, before deducting estimated commissions and allocated fees of $1.0 million. In June 2023, we filed with the SEC a universal shelf registration statement on Form S-3, or the Shelf Registration Statement, which allows 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 Shelf Registration Statement was filed to replace our prior universal shelf registration statement on Form S-3 and was declared effective on August 15, 2023. Further, in June 2023, we entered into a new sales agreement with Leerink Partners, LLC (formerly SVB Securities), which we refer to as the 2023 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 2023 ATM Sales Agreement. We filed a prospectus under the 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 2023 ATM Sales Agreement. In accordance with the terms of the 2023 ATM Sales Agreement, the 2020 ATM Sales Agreement terminated upon effectiveness of the Shelf Registration Statement, at which point we were no longer able to issue and sell shares of our common stock under the 2020 ATM Sales Agreement. As of December 31, 2024, we had issued and sold 4,498,065 shares of common stock for gross proceeds of $14.6 million, before deducting estimated commissions and allocated fees of $0.5 million under the 2023 ATM Sales Agreement. No shares have been sold under the 2023 ATM Sales Agreement for the three months ended March 31, 2025.

Previous wording

On September 27, 2022, we issued and sold 14,252,670 shares of our common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 14,247,330 shares of common stock in a public offering, or the September 2022 Offering, at a public offering price of $1.93 per share of common stock and $1.929 per pre-funded warrant pursuant to an underwriting agreement, or the Underwriting Agreement, with SVB Securities, Stifel, Nicolaus & Company, Incorporated and Oppenheimer & Co. Inc., as representatives of the several underwriters, or the Underwriters. Each pre-funded warrant has an exercise price of $0.001 per share, became exercisable immediately upon issuance and will be exercisable until the pre-funded warrant is exercised in full. Under the terms of the Underwriting Agreement, we granted the Underwriters an option, or the Option, exercisable for 30 days, to purchase up to an additional 4,275,000 shares of common stock, or the Additional Shares, at the public offering price of $1.93 per share. The Underwriters partially exercised the Option to purchase 1,600,428 Additional Shares, which shares were issued and sold on October 25, 2022. The September 2022 Offering, including the initial closing on September 27, 2022 and the Option closing on October 25, 2022, resulted in aggregate gross proceeds to us of approximately $58.1 million. As of October 31, 2024, pre-funded warrants to purchase 13,270,983 shares of common stock that we issued and sold in the September 2022 Offering remained outstanding.

Current wording

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.

Previous wording

During the nine months ended September 30, 2024, operating activities used $28.7 million of net cash, resulting from our net loss of $36.5 million partially offset by net changes in our operating assets and liabilities of $5.8 million and net non-cash charges of $2.0 million. Changes in our operating assets and liabilities consisted of a $3.3 million increase in accrued expenses and other liabilities and a $2.7 million decrease in prepaid expenses and other current assets partially offset by a $0.2 million decrease in accounts payable. The increase in accrued expenses and other liabilities was primarily due to an increase in accruals for clinical development and clinical trial work performed by our CROs. The decrease in prepaid expenses and other current assets was primarily due to a decrease in prepayments related to our 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 $2.7 million, $0.3 million change in value of our operating lease right-of-use assets and liabilities and $0.1 million of depreciation and amortization, partially offset by $1.1 million of accretion of our available-for-sale marketable securities.

Current 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.

Previous wording

During the nine months ended September 30, 2023, operating activities used $25.4 million of net cash, principally resulting from our net loss of $21.2 million and net changes in our operating assets and liabilities of $4.6 million. Changes in our operating assets and liabilities consisted of a $2.9 million increase in prepaid expenses and other current assets, a $1.7 million decrease in accounts payable and a slight increase in accrued expenses and other liabilities. 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 accounts payable was primarily due to the timing of vendor invoices. The increase in accrued expenses and other liabilities was primarily due to a decrease in accrued compensation and benefits and interest payable partially offset by an increase in accruals for research, development and clinical trial work performed by our CROs and consultants. Net cash used in operating activities for the nine months ended September 30, 2023, also included non-cash charges that consisted primarily of stock-based compensation expense of $1.7 million, a $0.3 million change in value of our operating lease right-of-use assets and $0.2 million of accretion/accrual of term loan discounts and debt issuance costs, which were partially offset by $1.8 million of accretion of our available-for-sale marketable securities.

Current wording

During the three months ended March 31, 2024, operating activities used $10.5 million of net cash, resulting from our net loss of $10.9 million and net changes in our operating assets and liabilities of $0.1 million, partially offset by net non-cash charges of $0.5 million. Changes in our operating assets and liabilities consisted of a $0.9 million decrease in accrued expenses and other liabilities partially offset by a $0.6 million decrease in prepaid expenses and other current assets and a $0.3 million increase in accounts payable. The decrease in accrued expenses and other liabilities was primarily due to a decrease in accrued compensation and benefits. The decrease in prepaid expenses and other current assets was primarily due to a decrease in prepayments related to our corporate insurance as well as our 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 $0.7 million and a $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.

Previous wording

During the nine months ended September 30, 2024, net cash provided by investing activities was $2.3 million, primarily related to $55.6 million of proceeds from maturities of available-for-sale marketable securities partially offset by $53.3 million of purchases of available-for-sale marketable securities.

Current 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.

Previous wording

During the nine months ended September 30, 2023, net cash provided by investing activities was $46.6 million, consisting primarily of $55.7 million of proceeds from maturities of available-for-sale marketable securities partially offset by $9.0 million of purchases of available-for-sale marketable securities and $0.1 million of purchases property, equipment and leasehold improvements.

Current wording

During the three months ended March 31, 2024, net cash used in investing activities was $8.1 million, primarily related to $30.3 million of purchases of available-for-sale marketable securities, partially offset by $22.2 million of proceeds from maturities of available-for-sale marketable securities.

Previous wording

During the nine months ended September 30, 2024, net cash provided by financing activities was $10.0 million, primarily consisting of cash proceeds of $9.7 million, net of commissions, from sales of our common stock under the 2023 ATM Sales Agreement, and $0.4 million of cash proceeds from the exercise of stock options, partially offset by $0.1 million of payments on our finance lease.

Current 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.

Previous wording

our Phase 1b TIDAL study to evaluate the effect of Haduvio on respiratory physiology in patients with IPF of varying disease severity; and

Current wording

our ongoing Phase 1 TIDAL study to evaluate the effect of Haduvio on respiratory function and safety in patients with IPF of varying disease severity;

Previous wording

We expect to continue to incur costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses.

Current wording

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.

Previous wording

the scope, progress, timing, costs and results of clinical trials of Haduvio, including our Phase 2b CORAL clinical trial of Haduvio for the treatment of chronic cough in IPF, our Phase 2a RIVER clinical trial in RCC, our HAP study, and our

Current wording

the scope, progress, timing, costs and results of clinical trials of Haduvio, including our ongoing Phase 2b CORAL clinical trial and our planned Phase 3 program of Haduvio, each for the treatment of chronic cough in patients with IPF, our ongoing Phase 1 TIDAL study to evaluate the effect of Haduvio on respiratory function and safety in patients with IPF of varying disease severity, our planned Phase 2a clinical trial of Haduvio for the treatment of chronic cough in patients with non-IPF ILD, our next clinical trial in patients with 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;

Previous wording

the costs of commercialization activities for Haduvio for the treatment of chronic cough in IPF 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 chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD and in patients with 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

subject to receipt of marketing approvals, revenue, if any, received from commercial sales of Haduvio for the treatment of chronic cough in IPF or RCC or for the treatment of prurigo nodularis, or from any future product candidates;

Current wording

subject to receipt of marketing approvals, revenue, if any, received from commercial sales of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD or in patients with RCC or from any future product candidates;

Previous wording

our ability to identify potential collaborators for Haduvio for the treatment of prurigo nodularis or for the treatment of chronic cough in IPF or RCC or for any future product candidates, and the terms and timing of any collaboration agreement that we may establish for the development and any commercialization of such product candidates;

Current wording

our ability to identify potential collaborators for Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD or in patients with RCC or for any future product candidates, and the terms and timing of any collaboration agreement that we may establish for the development and any commercialization of such product candidates;

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 the second half of 2026. Our current plans do not take into account the cost of any additional clinical trials of Haduvio.

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 the fourth quarter of 2026.

Previous wording

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 IPF 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.

Current wording

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, chronic cough in patients with non-IPF ILD or in patients with RCC or any other indication, including to conduct our planned clinical trials to completion. 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.

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, 2023, is the most important to understanding and evaluating our reported financial results. During the nine months ended September 30, 2024, 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, 2024, is the most important to understanding and evaluating our reported financial results. During the three months ended March 31, 2025, there were no material changes to our critical accounting policies.