TRVI 10-K & 10-Q changes, risk factors and insider trading

continue to develop and conduct clinical trials of Haduvio, including our ongoing Phase 2b CORAL clinical trial and our planned Phase 3 programtrials of Haduvio for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis, or IPF, our ongoingplanned adaptive design Phase 1b TIDAL study to evaluate the effect of Haduvio on respiratory physiology in patients with IPF of varying disease severity, and our planned2b clinical trialstrial of Haduvio for the treatment of chronic cough in patients with non-IPF interstitial lung disease, or non-IPF ILD, andour planned Phase 2b clinical trial of Haduvio for the treatment of patients with refractory chronic cough, or RCCRCC, and our planned Phase 1 NDA supportive studies;

seek regulatory and marketing approvals for Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD or RCC or for any future product candidate that successfully completes clinical trials, if any;

add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and to help us comply with our obligations as a public company; and add equipment and physical infrastructure to support our development program for Haduvio and for any future product candidates.

Our ability to become and remain profitable depends on our ability to generate revenue. We do not expect to generate significant revenue unless and until we are able to obtain marketing approval for and successfully commercialize Haduvio or any future product candidate. Successful commercialization will require achievement of key milestones, including completing clinical trials of Haduvio or any future product candidate, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those products for which we may obtain marketing approval, satisfying any post-marketing requirements and obtaining reimbursement for any such product from private insurance or government payors. For example, based on guidance from the FDA at an End-of-Phase 2 meeting in order to successfully commercialize Haduvio for the treatment of IPF-related chronic cough in patients with IPF,cough, we may be requiredplan to successfully complete atwo Phase 3 program that includes two clinical trials prior to submitting an NDA and MAA to regulatory authorities to obtain marketing approval. Because of the uncertainties and risks associated with these activities, we are unable to accurately predict the timing and amount of revenues and if or when we might achieve profitability. We may never succeed in these activities and, even if we do, we may never generate revenues that are large enough for us to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, develop a pipeline of product candidates or continue our operations.

Developing pharmaceutical products, including conducting preclinical and non-clinicalnonclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. We have consumed substantial amounts of cash since our inception. For example, in the years ended December 31, 20242025 and 2023,2024, we used net cash of $38.3$42.1 million and $31.7$38.3 million, respectively, in our operating activities, substantially all of which related to development activities for Haduvio. As of December 31, 2024,2025, our cash, cash equivalents and marketable securities were $107.6$188.3 million. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue to develop Haduvio, including as and if we:

conduct our ongoingplanned Phase 2b3 CORAL clinical trialtrials and any additional trials of Haduvio for the treatment of IPF-related chronic cough in patients with IPF;

conduct our planned adaptive design Phase 22b clinical trial and any additional trials of Haduvio for the treatment of non-IPF ILD-related chronic cough in patients with non-IPF ILD; and conduct our nextplanned Phase 2b clinical trial and any additional trials of Haduvio for the treatment of patients with RCC;RCC.

In addition, if we obtain marketing approval for Haduvio or any future product candidate, we may incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. For instance, we currently intend to commercialize Haduvio in the United States, or U.S., ourselves by developing a focused, specialty sales, marketing and distribution organization. Furthermore, we expect to continue to incur significant costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise sufficient capital when needed on acceptable terms or at all, we may be forced to delay, reduce or abandon our development programs or any future commercialization efforts.

We plan to use our existing cash, cash equivalents and marketable securities to fund the development of Haduvio and for working capital and other general corporate purposes. We will be required to expend significant funds to advance the development of Haduvio in multiple indications, as well as any future product candidates we may seek to develop. Our existing cash, cash equivalents and marketable securities will not be sufficient to complete development of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, in RCC, or for any other condition or of any future product candidate. 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 and licensing arrangements or other sources to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy.

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 programtrials of Haduvio for the treatment of chronic cough in patients with IPF, our ongoingplanned adaptive design Phase 1b2b TIDAL study to evaluate the effect of Haduvio on respiratory physiology in patients with IPF of varying disease severity, and our planned Phase 2clinical trial of Haduvio for the treatment of chronic cough in patients with non-IPF ILD andILD, our nextplanned plannedPhase 2b clinical trial for the treatment of patients with RCC, and our planned Phase 1 NDA supportive studies as well as trials for any future product candidates;

the outcome, timing and costs of clinical and non-clinicalnonclinical trials and of seeking regulatory approvals, including the costs of supportive clinical studies;

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 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;

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 RCC, or from any future product candidates;

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 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;

our potential obligation to make milestone payments to EndoKeenova PharmaceuticalsTherapeutics Inc.,plc, or Endo,Keenova, which would become due upon the successful completion of the first Phase 3 clinical trial of a licensed product candidate and the marketing approval of a licensed product in the U.S., as well as our potential obligations to pay EndoKeenova royalties on the net sales of the product;

conduct our ongoing Phase 2b CORAL clinical trial and our planned Phase 3 programtrials of Haduvio for the treatment of IPF-related chronic cough in patients with IPF;

conduct our nextplanned adaptive design Phase 2b clinical trial and any additional trials of Haduvio for the treatment of patientsnon-IPF withILD-related RCCchronic cough; and seek regulatory and marketing approvals for Haduvio.

We currently have no products approved for sale and are investing substantially all our efforts and financial resources to fund the development and commercialization of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, and RCC. Our prospects are dependent on our ability to develop, obtain marketing approval for and successfully commercialize Haduvio in one or more indications as we currently have no other product candidates under development. We may acquire or in-license rights to other potential product candidates or technologies in the future, but we are currently not developing any other product candidates.

Our most advanced programsprogram areis for the development of Haduvio for the treatment of IPF-related chronic cough in patients with IPF and RCC.cough. As a result, if our efforts to develop and commercialize Haduvio for the treatment of chronic cough in patients with IPFIPF, ornon-IPF ILD, and RCC are unsuccessful or we experience significant delays in doing so, our business could also be substantially harmed.

The success of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, and RCC will depend on several factors, including the following:

initiating and successfully recruiting, enrolling and retaining patients in and completing additional clinical and non-clinicalnonclinical trials of Haduvio, including the additional clinical trials we are conducting and plan to conduct for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD and RCC;

We are currently focused on the development and commercialization of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, and RCC. Haduvio is an oral extended-release formulation of nalbuphine, the active drug ingredient in Haduvio. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa receptor agonist and mu antagonist (KAMA). Kappa anda mu arereceptor antagonist, or KAMA, targeting opioid receptors that play a key role in controlling coughchronic hypersensitivity.cough. Nalbuphine has been approved and marketed as an injectable for pain indications for more than 30 yearsdecades in the U.S. and Europe and is currently not commercially available in an oral dosage form. While we believe that nalbuphine’s dual mechanism of action, which targets both the central and peripheral nervous systems, makes Haduvio a promising potential therapy for the treatment of chronic cough and that Haduvio has the potential to be safe and well-tolerated, nalbuphine has not been approved in any indications other than pain and balanced anesthesia. Additionally, Haduvio has not been approved in any indication. No therapies have been approved for the treatment of chronic cough in patients with IPF or non-IPF ILD, and no therapies have been approved in the U.S. for the treatment of patients with RCC. Gefapixant has been approved in Europe,Japan, the United Kingdom, Switzerland, and Japanthe E.U. for the treatment of patients with RCC. We can provide no assurance that Haduvio or any other future product candidate that we may seek to develop for chronic cough indications will be effective or safe, obtain regulatory approval or be commercially successful.

we may decide, or regulators may require us, to restructure clinical trials, conduct additional clinical and non-clinicalnonclinical trials or abandon product development programs;

Similarly, the regulatory landscape related to clinical trials in the European Union, or E.U., recentlyhas evolved.been evolving. The E.U. Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the E.U. Clinical Trials Directive, became applicable on January 31, 2022. While the Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each Member State of the E.U., or E.U. Member State, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application to all Member States concerned. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each Member State, leading to a single decision per Member State. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all Member States concerned, and a separate assessment by each Member State with respect to specific requirements related to its own territory, including ethics rules. Each Member State’s decision is communicated to the sponsor via the centralized E.U. portal. Once the CTA is approved, clinical study development may proceed. If we are not able to address these changes in existing requirements or the adoption of new requirements or policies governing clinical trials or there are difficulties with the implementation of the CTR process, our development plans may be impacted.

Our failure to successfully and timely complete clinical trials of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, orand RCC or of any future product candidate and to demonstrate the efficacy and safety necessary to obtain regulatory approval to market any such product candidates would significantly harm our business and could result in the loss or impairment of our ability to generate revenues and effectuate our business strategy.

Although the primary endpoint in our current and planned clinical trials of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, and RCC will be measured using an objective cough monitor, we have or expect to have PRO instruments as secondary endpoints.endpoints, including the key secondary endpoint. There is currently no validated PRO instrument that has been accepted for chronic cough indications.

In particular, the successful completion of our clinical development program for Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, and RCC is dependent upon our ability to enroll a sufficient number of patients with these severe conditions. We have experienced delays and difficulties in the enrollment of patients in certain of our clinical trials, including our Phase 2 CANAL trial, which delayed the completion of these trials.

Other companies are conducting clinical trials or have announced plans for future clinical trials that are seeking or are likely to seek to enroll patients with IPF, non-IPF ILD and patients with RCC, and patients are often only able to enroll in a single trial at a time. No therapies have been approved for the treatment of chronic cough in patients with IPF or non-IPF ILD and no therapies have been approved in the U.S. for the treatment of patients with RCC. However, patients with these conditions, as well as their physicians, may be reluctant to forgo, discontinue or otherwise alter their use of the therapeutic approaches they currently use in order to participate in our clinical trials.

In addition, Haduvio, as a KAMA,mixed agonist antagonist, may be susceptible to side effects associated with drugs having either of those mechanisms of action. Kappa-opioid receptor agonists have been associated with poorly tolerated psychiatric side effects, such as feelings of emotional and mental discomfort or dysphoria and hallucinations, at high doses. While we believe that the dualmixed kappa-opioid receptor agonist and mu-opioid receptor antagonist mechanism of action of nalbuphine reduces the likelihood of such psychiatric side effects, we have observed mild psychiatric side effects, including a few reported cases of mild euphoria, somnolence and feeling relaxed or feeling “high,” in clinical trials of Haduvio to date. Mu-opioid receptor antagonists have the potential to precipitate withdrawal effects in patients,patients includingwho drugare addicts.currently Toon supportchronic our planned submissiondoses of anmu-agonist NDA to the FDA for Haduvio, due to the association of opioids with endocrine dysfunction, we may be required to conduct a clinical trial of Haduvio to evaluate potential endocrine side effects.opiates. We cannot be certain that any of these side effects often associated with opioids, or other side effects, will not be observed or observed at more severe levels in the future or that the FDA will not require additional trials or impose more severe labeling restrictions due to these side effects or other concerns. Such drug-related side effects could also affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims.

In our Phase 22b CANALCORAL trial of Haduvio for the treatment of IPF-related chronic cough in patients with IPF,cough, the most frequently reported treatment emergent adverse events associated with Haduvio were nausea, fatigue,vomiting, constipation, dizziness, vomiting, headache, constipationfatigue, somnolence, and somnolence.dry mouth. In our Phase 2a RIVER trial of Haduvio for the treatment of RCC, the most frequently reported treatment emergent adverse events associated with Haduvio were constipation, nausea, somnolence, headache, dizziness, and fatigue.

OpioidsMu-opioid receptor agonists as a class are associated with respiratory depression. The drug label for the currently marketed parenterally administered formulation of nalbuphine, the active ingredient in Haduvio, carries an opioid class label warning for serious, life-threatening or fatal respiratory depression and Haduvio, if approved for marketing in any indication, will likely carry a similar opioid class label. We are conducting our Phase 1b1 TIDAL study to evaluate the effect of Haduvio on respiratory physiologyfunction and safety in patients with IPF of varying disease severity. We cannot be certain that respiratory depression will not be observed or that the FDA will not require additional trials or impose more severe labeling restrictions related to respiratory depression. If there is a safety signal in the Phase 1b1 study, it could affect our ability to conduct a trial in this patient population.

Many currently approved mu-opioid receptor agonist products are subject to restrictive marketing and distribution regulations which, if applied to Haduvio, could potentially restrict its use and harm our ability to generate profits.

In addition, the parenteral formulation of nalbuphine is currently not scheduled as a controlled substance under the federal Controlled Substances Act of 1970 or the regulations of the U.S. Drug Enforcement Agency, or the DEA, in the U.S. The DEA regulates controlled substances as Schedule I, II, III, IV or V substances. Schedule I substances by definition have no established medicinal use and may not be marketed or sold in the U.S. A pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of abuse and carrying the greater level of regulatory control and Schedule V substances considered to present the lowest relative risk of abuse among such substances and, accordingly, the lowest level of regulatory control. Various states also independently regulate controlled substances. Though state-controlled substance laws often mirror federal law, because the states are separate jurisdictions, they may separately regulate drugs as well. While some states automatically classify a drug when the DEA does so, in other states there must be rulemaking or a legislative action. Regulatory authorities in foreign jurisdictions may also determine to classify Haduvio as a controlled substance under different, but potentially no less burdensome, regulations. In our HAP trial, we compared Haduvio with butorphanol, which is currently classified as a Schedule IV substance. BecauseNalbuphine has been available for decades and was regularly kept unscheduled by the DEA. In addition, Haduvio was less likable than butorphanol in the HAP study and because the DEA will evaluate the HAP results together with other elements of the 8-factor plan required to determine scheduling, our current expectation is that Haduvio will remain unscheduled.scheduling. However, it is possible that the DEA could determine that Haduvio, which is an oral, extended-release formulation, should be classified as a Schedule V or Schedule IV substance.

If Haduvio is classified as a controlled substance, the level of regulation would depend on how it is scheduled and we and our suppliers, manufacturers, contractors, distributors and any future customers would be required to obtain and maintain any applicable registrations from state, federal and foreign law enforcement and regulatory agencies and comply with any applicable state, federal and foreign laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances. Also, ifIf Haduvio is classified as a controlled substance, there is a risk that such regulationsit could limit its supply for use in clinical trials and, in the future, limit our ability to produce and distribute Haduvio in the volume needed to meet potential commercial demand.

The outcome of preclinical studies and clinical trials may not be predictive of the success of later clinical trials and preliminary or interim results of clinical trials do not necessarily predict final results. For instance, Haduvio or any future product candidate may fail to show the desired safety and efficacy in patients with chronic choughcough with IPF, with chronic chough with non-IPRnon-IPF ILD, and RCC in future clinical trials despite demonstrating positive results in preclinical studies or earlier clinical trials. The results of our Phase 22b CANALCORAL trial for the treatment of IPF-related chronic cough in patients with IPF and the results ofor our Phase 2a RIVER trial for the treatment of patients with RCC may not be predictive of the results of future trials of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, or RCC. Many pharmaceutical and biotechnology companies have suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier stages of clinical development and we could face similar setbacks. Similarly, the design of a clinical trial can determine whether its results will support marketing approval of a product and adjustments in the design of a clinical trial may not be possible once the clinical trial has commenced.

In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of patient populations, changes in and adherence to dosing regimens and other clinical trial protocols, as well as the rate of discontinuation among clinical trial participants. If we fail to receivedemonstrate positive results in clinical trials of Haduvio or any future product candidate, the development timeline and regulatory approval and commercialization prospects for those product candidates and, correspondingly, our business and financial prospects would be negatively impacted.

Because we have limited financial and managerial resources, we intend to focus on developing product candidates for specific indications that we identify as most likely to succeed, in terms of both their potential for marketing approval and commercialization. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that may prove to have greater commercial potential. For example, we currently intend to focus our resources on the development of Haduvio for the treatment of chronic cough in patients with IPF, chronic cough in patients with non-IPF ILD, and for the treatment of patients with RCC. However, the development of Haduvio for these indications may ultimately prove to be unsuccessful or less successful than another product candidate or other indications that we might have chosen to pursue with our limited resources.

We do not currently have a sales, marketing or distribution infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product, we must either develop a sales and marketing organization or outsource these functions to third parties. If Haduvio were to receive marketing approval from the FDA for chronic cough in patients with IPF orIPF-related chronic cough in patients withor non-IPF ILD,ILD-related chronic cough, we would plan to market and commercialize Haduvio in the U.S. with our own focused, specialty sales force,force which wouldand target pulmonologists who specialize in treating IPF and non-IPF ILD patients, as well as ILD centers of excellence, as applicable. If Haduvio were to receive marketing approval from the FDA for RCC, we would plan to market and commercialize Haduvio in the U.S. with our own focused sales force targetingand target pulmonologists and other specialists, such as allergists, who treat RCC patients who have failed other therapies for chronic cough therapies.cough. We also expect to utilize a variety of collaboration, distribution and other marketing arrangements with one or more third parties to commercialize Haduvio outside the U.S.

We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.

The development and commercialization of new products is highly competitive. We expect that we will face significant competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to Haduvio or any future product candidate that we may seek to develop or commercialize. Our competitors may succeed in developing, acquiring or licensing technologies and products that are more effective, have fewer or more tolerable side effects or are more convenient or less costly than Haduvio or any future product candidate we may develop, which could render any product candidates obsolete and noncompetitive. Our competitors also may obtain FDA or other marketing approval for their products before we are able to obtain approval for ours, which could result in competitors establishing a strong market position before we are able to enter the applicable market.

If Haduvio is approved for the treatment of chronic cough in patients with IPF,IPF and non-IPF ILD, we expect that it may compete with product candidates currentlythat inmay clinicalbe developmentdeveloped for the treatment of chronic cough in patients with IPF,IPF suchor asILD. orvepitant,Development a NK1 receptor antagonist, which is being developed by Nerre Therapeutics, ME-015, a reactive oxygen species scavenger, which is being developed by Melius Pharma,of BI 1839100, whicha isTRPA1 being developedantagonist by Boehringer Ingelheim, and ifenprodil, a NMDA receptor antagonist, which is being developed by Seyltx, Inc. Currently there are no product candidates in clinical developmentIngelheim for the treatment of IPF-related chronic cough and progressive pulmonary fibrosis, was terminated in patientsSeptember with2025. non-IPF ILD. In addition, itIt is possible that product candidates currently in development for the treatment of the fibrosis in patients with IPF and ILD could, if approved, reduce the need for therapies to treat chronic cough in patients with IPF and non-IPF ILD. We expect that Haduvio might also compete with other product candidates currently in development, or submitted for approval to the FDA, for the treatment of patients with RCC and unexplained chronic cough that might be used off-label to treat IPF-related chronic cough in patients with IPF.cough.

If Haduvio is approved for the treatment of patients with RCC, we expect that it may compete with product candidates currently in clinical development for the treatment of patients with RCC,RCC such as camlipixant, a P2X3 antagonist, which is being developed by GSK plc. Gefapixant, a P2X3 antagonist, which was being developed by Merck & Co., Inc., or Merck, is approved for refractory or unexplained chronic cough in JapanJapan, the United Kingdom, Switzerland, and the E.U. The application filed with the FDA was withdrawn and MerekMerck indicated it does not plan to refile. Other product candidates that are currently in development for the treatment of patients with RCC include taplucainium (formerly NTX-1175), a charged sodium channel blocker, which is being developed by Nocion Therapeutics Inc., AX-8, a TRPM8 antagonist, which is being developed by Axalbion Therapeutics Ltd., GABAB PAM, a GABA agonist, which is being developed by Addex Therapeutics Ltd., and ifenprodil, a NMDA receptor antagonist, which is being developed by Seyltx, Inc.

We currently have no manufacturing facilities and a relatively small number of personnel with sufficient experience to oversee the manufacturing process. We rely and plan to continue to rely, on contract manufacturers and other third partythird-party contractors to manufacture, store, package and distribute both drug substance and drug product for our clinical trials. If any of our product candidates receive regulatory approval, we plan to continue to rely upon contract manufacturers and, potentially, collaboration partners, to manufacture commercial quantities of such products. We may be unable to establish any further agreements with contract manufacturers or any other third-party contractors or may fail to do so on acceptable terms or when needed. Even if we are able to establish agreements with such third partythird-party contractors, reliance on third partythird-party contractors entails additional risks, including:

manufacturing delays if our third partythird-party contractors experience supply chain-related delays, prioritize the supply of other companies’ products over Haduvio or any other drug product needed for our clinical trials or any future product candidates, or otherwise fail to satisfactorily perform according to the terms of the agreements between us and them or if unforeseen events in the manufacturing process arise;

the possible termination or nonrenewal of agreements by our third partythird-party contractors at a time that is costly or inconvenient for us;

the possible breach by third partythird-party contractors of our agreements with them;

the failure of third partythird-party contractors to comply with applicable regulatory requirements;

We do not have long-term supply agreements with any of our contract manufacturers. If any of our existing manufacturers should become unavailable to us for any reason or fail to supply us with the ordered quantities, we may incur delays in identifying or qualifying replacement manufacturers or in obtaining replacement supply. Any performance failure on the part of our contract manufacturers or the other third partythird-party contractors that we use to store and distribute drug substance and drug product could be disruptive to our operations and delay clinical development or marketing approval of Haduvio or any future product candidates of ours or commercialization of any resulting products, producing additional losses and depriving us of potential product revenue.

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 diseasedisease, 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 a kappa receptor agonist and a mu antagonist,receptor orantagonist KAMA.(“KAMA”), Kappa and mu aretargeting opioid receptors that play a key role in controlling coughchronic hypersensitivity.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 yearsdecades 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 inby the U.S. Drug Enforcement Agency and in most of Europe.

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 infor the treatment of patients with RCC, which we refer to as the Phase 2a RIVER trial. The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study that was designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for the treatment of patients with RCC. 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).population. In the trial, Haduvio met the primary endpoint at Day 21 with a statistically significant reduction in the objective 24-hour cough frequency of 67% from baselineBaseline and 57% from Baseline on a placebo-adjusted basis (p<0.0001). PatientPlanned analyses of all pre-specified secondary endpoints, including patient reported andendpoints, other secondary outcomes reported inat the top-lineend dataof treatment were statistically significant and consistent with the primary endpoint. Haduvio demonstrated aalso 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).significant. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials in other patient populations and there were no serious adverse events reported in the trial.

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 December 31, 2024,2025, we had an accumulated deficit of $287.0$329.8 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, chronic cough in patients with non-IPF ILD, or RCC and we can provide no assurance that we will ever generate significant revenue or profits.

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 programtrials for the treatment of IPF-related chronic cough in patients with IPF, our ongoing Phase 1b TIDAL respiratory physiology study in patients with IPF of varying disease severity,cough, our planned adaptive design Phase 22b clinical trial of Haduvio for the treatment of non-IPF ILD-related chronic cough in patients with non-IPF ILD, andcough, our nextplanned Phase 2b clinical trial of Haduvio for the treatment of patients with RCC.RCC, and any supportive studies necessary for regulatory approval.

We will need substantial additional funding to support our continuing operations and pursue development and commercialization of Haduvio. Until such time asthat 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.

We anticipate that our general and administrative expenses will increase as a result of increased personnel costs, including stock-based compensation and expanded infrastructure. We also anticipate that our general and administrative expenses will increase as we expect to continue to incur increased costs as we continue to prepare for compliance with Section 404 of the Sarbanes-Oxley Act of 2002, or SOX 404(b).

General and administrative expenses for the year ended December 31, 20242025 increased $1.9 million, or 18.6%, to $12.1$15.9 million from $10.2$12.1 million for the yearcorresponding endedperiod Decemberin 31, 2023,2024, primarily due to increasesan increase in personnel-relatedoutside expenses,services and professional fees, personnel related expenses and stock-based compensation. The increased outside services and professional fees were primarily due to increased costs as we continue to prepare for compliance with SOX 404(b). The increased personnel related expenses and stock-based compensation expense,were informationprimarily technologydue serviceto severance costs andalong marketwith researchincreased costs.headcount.

Other income, net for the year ended December 31, 20242025 decreasedwas by$6.5 $1.2million million, or 25.8%compared to other income, net of $3.6 million from $4.8 million for the yearcorresponding endedperiod Decemberin 31, 2023.2024. The decreasechange was primarily due to aan decreaseincrease in interest income offrom $1.1higher million due to lowerinvested cash equivalent and marketable securities balances.

On DecemberJune 17,5, 2024,2025, we issued and sold 12,500,00017,400,000 shares of our common stock to certainthe investorspublic in an underwritten registered direct offering, or the DecemberJune 20242025 Offering, at an offering price of $4.00$5.75 per share of common stock pursuant to an underwriting agreement, or the Underwriting Agreement,agreement with Morgan Stanley & Co. LLC, Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated and OppenheimerCantor Fitzgerald & Co. Inc,Co., as representatives of the several underwriters. In connection with the offering, we also granted the underwriters a 30-day option to purchase up to an additional 2,610,000 shares of common stock at the price to the public, less underwriting discounts and commissions. The Decemberunderwriters 2024option was exercised in full and settled in cash, concurrent with the offering. The June 2025 Offering resulted in aggregate gross proceeds to us of approximately $50.0$115.1 million.

During the year ended December 31, 2024,2025, operating activities used $38.3$42.1 million of net cash, resulting from our net loss of $47.9$42.8 million partially offset byand changes in our operating assets and liabilities of $6.8$3.5 million andpartially offset by net non-cash charges of $2.8$4.2 million. Changes in our operating assets and liabilities for the year ended December 31, 20242025 consisted primarily of a $2.7$1.5 million decreaseincrease in prepaid expenses and other current assets, a $2.6$1.4 million increasedecrease in accrued expenses and other liabilities and a $1.6$0.6 million increasedecrease in accounts payable. The decreaseincrease in prepaid expenses and other current assets was primarily due to aan decreaseincrease in prepaymentsaccrued interest and dividends receivable from our higher invested cash equivalent and marketable securities balances, as well as an increase in deposits related to our clinical trial work performed by our CROs. The increasedecrease in accrued expenses and other liabilities was primarily due to ana increasedecrease in accruals for clinical development and clinical trial work performed by our CROs. The increasedecrease in accounts payable was primarily due to the timing of vendor invoices. The non-cash charges consisted primarily of stock-based compensation expense of $3.6$5.2 million, and a $0.5$0.4 million change in value of our operating lease right-of-use assets and $0.1 million of depreciation and amortization expense,liabilities, which were partially offset by $1.4$1.6 million of accretion of our available-for-sale marketable securities.

During the year ended December 31, 2023,2024, operating activities used $31.7$38.3 million of net cash, resulting from our net loss of $29.1$47.9 million andpartially offset by changes in our operating assets and liabilities of $3.8$6.8 million,million partially offset byand net non-cash charges of $1.2$2.8 million. Changes in our operating assets and liabilities for the year ended December 31, 20232024 consisted primarily of a $2.9$2.7 million increasedecrease in prepaid expenses and other current assetsassets, a $2.6 million increase in accrued expenses and other liabilities and a $1.0$1.6 million decreaseincrease in accounts payable. The increasedecrease in prepaid expenses and other current assets was primarily due to ana increasedecrease in prepayments related to our clinical trial work performed by our CROs. The decreaseincrease 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 increase in accounts payable was primarily due to the timing of vendor invoices. The non-cash charges consisted primarily of stock-based compensation expense of $2.2$3.6 million, $0.4 million for the write off of deferred offering costs, a $0.4$0.5 million change in value of our operating lease right-of-use assets and liabilities and $0.2 million of accretion/accrual of term loan discounts and debt issuance costs,assets, which were partially offset by $2.1$1.4 million of accretion of our available-for-sale marketable securities.

During the year ended December 31, 2024,2025, net cash used in investing activities was $21.5$94.1 million, consistingprimarily ofrelated $98.5to $170.7 million of purchases of available-for-sale marketable securities and less than $0.1 million of purchases of property, equipment and leasehold improvements, partially offset by $77.0$76.6 million of proceeds from maturities of available-for-sale marketable securities.

During the year ended December 31, 2023,2024, net cash providedused byin investing activities was $59.4$21.5 million, consisting of $69.5$98.5 million of purchases of available-for-sale marketable securities, partially offset by $77.0 million of proceeds from maturities of available-for-sale marketable securities, partially offset by $9.9 million of purchases of available-for-sale marketable securities and $0.1 million of purchases of property, equipment and leasehold improvements.securities.

During the year ended December 31, 2024,2025, net cash provided by financing activities was $61.5$121.0 million, primarily consisting of cash proceeds of $47.0$108.2 million, net of commissions from sales of our common stock in our DecemberJune 20242025 Offering, cash$10.8 proceedsmillion from the exercise of $14.1warrants, million, net of commissions from sales of our common stock under the ATM Sales Agreement, $0.4$2.1 million of cash proceeds from the exercise of stock options and $0.1$0.7 million from the disgorgement of cashshort proceedsswing profits from salesa underbeneficial owner of our 2019common Employee Stock Purchase Plan. These cash inflows werestock, partially offset by $0.8 million in payments of $0.1offering millioncosts onrelated ourto financethe lease.June 2025 and December 2024 Offerings.

During the year ended December 31, 2023,2024, net cash usedprovided inby financing activities was $7.9$61.5 million, consisting of repaymentscash proceeds of $9.4$47.0 millionmillion, on the SVB Term Loan including paymentnet of thecommissions finalfrom payment fee and prepayment premium, both associated with the payoffsales of theour SVBcommon Termstock Loan, payments of offering costs of $0.3 million and payments of $0.1 million onin our financeDecember lease.2024 These cash outflows were partially offset byOffering, cash proceeds of $1.7$14.1 million, net of commissions from sales of our common stock under the ATM Sales Agreement, $0.1$0.4 million of cash proceeds from the exercise of stock options and $0.1 million of cash proceeds from sales under our 2019 Employee Stock Purchase Plan.options.

our ongoingplanned Phase 2b3 CORAL clinical trialtrials and any additional trials of Haduvio for the treatment of IPF-related chronic cough in patients with IPF;

our planned adaptive design Phase 22b clinical trial and any additional trials of Haduvio for the treatment of non-IPF ILD-related chronic cough in patients with non-IPF ILD; and our next clinical trial and any additional trials of Haduvio for the treatment of patients with RCC.

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 programtrials of Haduvio, eachHaduvio for the treatment of IPF-related chronic cough in patients with IPF, our ongoing Phase 1b TIDAL study to evaluate the effect of Haduvio on respiratory physiology in patients with IPF of varying disease severity,cough, our planned adaptive design Phase 22b clinical trial of Haduvio for the treatment of non-IPF ILD-related chronic coughcough, inour patientsplanned withPhase non-IPF2b ILD,clinical trial for the treatment of RCC, and our nextplanned clinicalPhase trial1 inNDA patientssupportive with RCC,studies, as well as trials for any future product candidates and the costs of seeking regulatory approvals;

the costs of commercialization activities for Haduvio for the treatment of chronic cough in patients with IPF,IPF-related chronic cough in patients withcough, 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;

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 RCC or from any future product candidates;

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

our potential obligation to make milestone payments to EndoKeenova PharmaceuticalsTherapeutics Inc.,plc, or Endo,Keenova, which would become due upon the successful completion of the first Phase 3 clinical trial of a licensed product candidate and the marketing approval of a licensed product in the U.S., as well as our potential obligations to pay EndoKeenova royalties on the net sales of the product;

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 RCC or any other indication, including to conduct our planned clinical trials to completion.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.

A significant portion of our development activities are outsourced to third parties under agreements, including with CROs and contract manufacturers in connection with the production of clinical trial materials. The contracts are cancelable at any time by us, generally upon 45 to 60 days' prior written notice to the CRO, and therefore we believe that our non-cancelable obligations under these agreements are not material.

See our previously disclosedOur risk factors have not changed materially from those described in "Part I, Item 1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2025.2025, except for the risk factors noted below.

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 planinitiated to conduct theour Phase 3 trials in parallel, with the first Phase 3OCEAN-1 trial to be initiated in the second quarter of 2026 and theplan secondto initiate our Phase 3 OCEAN-2 trial to be initiated in the secondthird halfquarter 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 trialsOCEAN-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 endpointendpoints measured at 52 weeks of fixed dosing. The protocol for the second of the two Phase 3 trialsOCEAN-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 will beis 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 willis be relativeabsolute change from Baseline in the coughCough severitySeverity numericalNumerical ratingRating scaleScale (CS-NRS). These trial designstrials are subject to final review of the protocols by theregulatory FDA.authorities. We expect to have topline results from the first Phase 3 OCEAN-1 trial in the first half of 2028 and from the second Phase 3 OCEAN-2 trial in the second half of 2027.

Non-IPF ILD-related Chronic Cough Program. We are also developing Haduvio for the treatment of non-IPF ILD-related chronic cough. We 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.

We expectinitiated to initiate aour Phase 2b LAKE trial of Haduvio for the treatment of patients with RCC in the second quarter of 2026. We are planning to conductconducting 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 trial is subject to review of the protocol by regulatory authorities. The protocol will provideprovides for a sample size re-estimation, or SSRE, analysis,analysis once 50% of the patients complete treatment, which is expected to occur in the fourth quarter of 20262026. We will report the outcome of the SSRE once available and expect to report topline results forfrom the clinical trial expected to occur in the second half of 2027.

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. We have completed the clinical portion of our respiratory safety study.

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 MarchJune 31,30, 2026, we had an accumulated deficit of $343.0$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.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $171.8$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.

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 trialsOCEAN-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 plannedongoing Phase 2b LAKE clinical trial of Haduvio for the treatment of patients with RCC, and our ongoing and planned Phase 1 NDA supportive studies.

Other Income (Expense), Income, Net

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

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses for the three months ended MarchJune 31,30, 2026 increased to $9.9$15.2 million from $7.8$9.4 million for the corresponding period in 2025, primarily due to increased clinical development expenses fordue 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, Phaseas 3well IPF-relatedas chronicincreases coughin trialsstock-based compensation and Phasepersonnel-related 2bexpenses. RCCThese trial,increases were partially offset by adecreased decrease in clinical development expensescosts for our Phase 2b CORAL trial and Phase 2a RIVER trial.

General and administrative expenses for the three months ended MarchJune 31,30, 2026 increased to $5.0$5.4 million from $3.7$4.3 million for the corresponding period in 2025, primarily due to higheran legal fees associated with intellectual property filings as well as increasesincrease in stock-based compensation expense and personnel-related expenses.expenses, partially offset by decreased outside services and professional fees.

Other income, net for the three months ended MarchJune 31,30, 2026 increasedwas $2.7 million compared to $1.7 million from $1.1$1.4 million for the corresponding period in 2025,2025. The change was primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.

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$162.3 million, after deducting underwriting discounts and commissions and estimated offering expenses.

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 threesix months ended MarchJune 31,30, 2026.

During the threesix months ended MarchJune 31,30, 2026, operating activities used $16.7$34.1 million of net cash, resulting from our net loss of $13.2$31.0 million and net changes in our operating assets and liabilities of $5.4$7.9 million, partially offset by net non-cash charges of $1.9$4.8 million. Changes in our operating assets and liabilities consisted of $2.8a $5.8 million increase in prepaid expenses and other current assets, a $1.5$1.8 million decrease in accounts payable,payable and a $1.1$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 and prepayments 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 $2.2$5.5 million,million and a $0.2 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $0.4$1.0 million of accretion of our available-for-sale marketable securities.

During the threesix months ended MarchJune 31,30, 2025, operating activities used $13.5$23.6 million of net cash, resulting from our net loss of $10.3$22.6 million and net changes in our operating assets and liabilities of $4.1$3.1 million, partially offset by net non-cash charges of $1.0$2.1 million. Changes in our operating assets and liabilities consisted of a $2.0$1.6 million decreaseincrease in accountsprepaid payable,expenses and other current assets, a $1.5$1.0 million decrease in accrued expenses and other liabilities and a $0.6$0.4 million decrease in accounts payable. The increase in prepaid expenses and other current assets. The decrease in accounts payableassets was primarily due to thean timingincrease in prepayments related to our clinical trial work performed by our CROs as well as an increase in prepayments of vendorour invoices.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 increasedecrease in prepaidaccounts expenses and other current assetspayable was primarily due to anthe increasetiming inof prepaymentsvendor related to our clinical trial work performed by our CROs.invoices. The non-cash charges consisted primarily of stock-based compensation expense of $1.2$2.6 million,million $0.1and a $0.2 million change in value of our operating lease right-of-use assets and liabilities, partially offset by $0.4$0.8 million of accretion of our available-for-sale marketable securities.

During the threesix months ended MarchJune 31,30, 2025,2026, net cash used in investing activities was $10.0$95.1 million, primarily related to $27.5$162.1 million of purchases of available-for-sale marketable securities partially offset by $17.6$67.2 million of proceeds from maturities of available-for-sale marketable securities.

During the threesix months ended MarchJune 31,30, 2025,2026, net cash provided by financing activities was $8.7$164.6 million, primarily consisting of cash proceeds of $8.2$163.0 millionmillion, net of commissions from the exercisesales of warrantsour common stock in our April 2026 Offering and $0.7$1.9 million of cash proceeds from the exercise of stock options partially offset by $0.2$0.4 million in payments of offering costs related to the DecemberApril 20242026 Offering.

our ongoing Phase 3 OCEAN-1 trial and planned Phase 3 trialsOCEAN-2 trial and any additional trials of Haduvio for the treatment of IPF-related chronic cough;

our plannedongoing Phase 2b LAKE clinical trial and any additional trials of Haduvio for the treatment of patients with RCC; and our ongoing and planned Phase 1 NDA supportive studies.

the scope, progress, timing, costs and results of clinical trials of Haduvio, including our ongoing Phase 3 OCEAN-1 trial and planned Phase 3 trialsOCEAN-2 trial of HaduvioHaduvio, 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 plannedongoing 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;

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 twoongoing Phase 3 OCEAN-1 trial and planned Phase 3 trials,OCEAN-2 potentiallytrial, through potential U.S. FDA approval. We also expect that these cash resources will enable us to fund and report topline data from our planned Phase 2bthe clinical trialdevelopment andprogram potentially a subsequentthrough Phase 3 clinical trial for the treatment of patients with non-IPF ILD,ILD-related chronic cough, and our plannedongoing 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 thea conductPhase of any other3 clinical trials.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.

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 threesix months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies.