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

•Our prospects are highly dependent on the success of our only approved product,products, ARIKAYCE.ARIKAYCE and BRINSUPRI. If we are unable to continue to successfully market andmarket, commercialize orand maintain approval for ARIKAYCE,ARIKAYCE and BRINSUPRI, our business, financial condition, results of operations and prospects and the value of our common stock willmay be materially adversely affected.

•We may not be able to obtain regulatory approvals for brensocatib, TPIP, or for our other product candidates and we may not be able to receive approval for ARIKAYCE in front-line NTM lung diseasedisease, for ARIKAYCE or BRINSUPRI in newadditional markets.markets or for our product candidates. Any such failure to obtain regulatory approvals, particularly for brensocatib in the US,approvals may materially adversely affect us.

•The commercial success of ARIKAYCE dependsand BRINSUPRI depend on continued market acceptance by physicians, patients, third-party payors and others in the healthcare community, and the commercial success of brensocatib, TPIP, or our other product candidates, if approved, will similarly depend on such market acceptance.

•We obtained regulatory approval of ARIKAYCE in the US through an accelerated approval process, and full approval will be contingent on successful and timely completion of a confirmatory post-marketing clinical trial. Failure to obtain full approval or otherwise meet our post-marketing requirements and commitments may have a material adverse effect on our business, prospects, and the value of our common stock.

•We remainare subject to substantial, ongoing regulatory requirementsrequirements, relatedincluding with respect to ARIKAYCE,advertising and promotion, and failure to comply with these requirements couldmay lead to enforcement action or otherwise materially harm our business.

•If we are unable to obtain or maintain adequate reimbursement from government or third-party payors for ARIKAYCEARIKAYCE, or, if approved, brensocatib, TPIP,BRINSUPRI or our other product candidates, if approved, or if we are unable to obtain or maintain acceptable prices for ARIKAYCE, BRINSUPRI, or, if approved, brensocatib, TPIP, or our other product candidates, our prospects for generating revenue and achieving profitability willmay be materially adversely affected.

•ARIKAYCE, brensocatib, TPIP,BRINSUPRI, or any of our other product candidates couldmay develop unexpected safety or efficacy concerns, which couldmay have a material adverse effect on us.

•If our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP,BRINSUPRI, or our other product candidates are overstated or data we have used to identify physicians isprove inaccurate, our ability to earngenerate revenue to support our business couldmay be materially adversely affected.

•Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available, may be interpreted differently if additional data are disclosed, and are subject to audit and verification procedures that couldmay result in material changes in the final data.

•If our clinical studies do not produce positive results or our clinical trials are delayed, or if serious side effects are identified during drug development, we may experience delays, incur additional costs and ultimately be unable to obtain regulatory approval for and successfully commercialize our product candidates in the US, Europe, Japan or other markets.

•We may not be able to enroll enough patients to conduct and complete our clinical trials or retain a sufficient number of patients in our clinical trials to generate the data necessary for regulatory approval of our product candidates or to permitgain the approval of the use of ARIKAYCE in the broader population of patients with MAC lung disease.

•If another party obtains orphan drug exclusivity for a product that is considered the same or essentially the same as a product we are developing for a particular indication, we may be precluded from or delayed fromin commercializing the product in that indication.

•Our clinical and pre-clinical research activities include the research and development of novel gene therapy product candidates. It will be difficult to predict the time and cost of development and of subsequently obtaining regulatory approval for any such gene therapy product candidates, or how long it will take to commercialize any gene therapy product candidates.

•We may not have, or may be unable to obtain, sufficient quantities of ARIKAYCE, LamiraLamira, BRINSUPRI, or our product candidates to meet our required supply for commercialization or clinical studies, which wouldmay materially harm our business.

•Adverse consequences to our business couldmay result if we andor our manufacturing partners fail to comply with applicable regulations or maintain required approvals.

•We are dependent uponon retaining and attracting key personnel, the loss of whose services couldmay materially adversely affect our business, financial condition, results of operations and prospectsprospects, and the value of our common stock.

•We expect to continue to expand our development, regulatory and sales and marketing capabilities, and as a result, may encounter difficulties in managing our growth, which couldmay disrupt our operations.

•Any acquisitions we make,have made or may make in the future, or collaborative relationships we have entered into or may in the future enter into, may not be clinically or commercially successful, and may require financing or a significant amount of cash, which could adversely affect our business.

•Our business and operations, including our drug development and commercialization programs, couldmay be materially disrupted and/or subject to reputational harm in the event of system failures, security breaches, cyber-attacks, deficiencies in our cybersecurity, violations of data protection laws or data loss or damage by us or third parties.

•We are subject to data privacy laws and regulations that govern how we can collect, process, store and transfer personal data and sensitive data, and violations canmay result in meaningful penalties, enforcement, and/or reputational harm and have a significant impact on our operations.

•We have limited experience operating internationally, are subject to a number of risks associated with our international activities and operations and may not be successful in any efforts to further expand internationally.

•We have a limited number of significant customers and losing any of them couldmay have an adverse effect on our financial condition and results of operations.

•Deterioration in general economic conditions in the US, Europe, Japan and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, couldmay harm our business and results of operations.

•If we are unable to adequately protect our intellectual property rights, the value of ARIKAYCEARIKAYCE, BRINSUPRI, and our product candidates couldmay be materially diminished.

•If we fail to comply with obligations in our third-party agreements, our business couldmay be adversely affected, including as a result ofby the loss of license rights that are important to our business.

•GovernmentHealthcare healthcarelegislation reformor couldother materiallygovernment increaseaction our costs, which couldmay materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.

•IfWe weare failsubject to comply with applicable laws, including "fraud and abuse" laws, anti-corruption laws and trade control laws, as well as other laws governing our operations. If we couldfail to comply with these laws, we may be subject to negative publicity, civil or criminal penalties, other remedial measures, and legal expenses, which couldmay adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.

•We have a history of operating losses, expect to incur operating losses forin the foreseeablenear futureterm, and may never achieve or maintain profitability.

•We may need to raise additional funds to continue our operations, and any failure to obtain capital when needed on acceptable terms, or at all, couldmay force us to delay, reduce or eliminate our development programs, commercialization efforts, or other operations.

•We have outstanding indebtedness in the form of convertible senior notes, a term loan and a royalty financing arrangement and may incur additional indebtedness in the future, which couldmay adversely affect our financial position, prevent us from implementing our strategy, andand, in certain cases, dilute the ownership interest of our existing shareholders.

•Goodwill impairment charges in the future couldmay have a material adverse effect on our business, results of operations and financial condition.

•Our shareholders may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock for general corporate purposes and upon the conversion of the 2028 Convertible Notes.stock.

•Certain provisions of Virginia law, our articles of incorporation and amended and restated bylaws and arrangements between us and our employees couldmay hamper a third party’s acquisition of us or discourage a third party from attempting to acquire control of us.

Risks Related to the Commercialization and Continued Approval of ARIKAYCE,ARIKAYCE and BRINSUPRI, and the Potential Approval and Commercialization of Brensocatibour andProduct TPIPCandidates

Our prospects are highly dependent on the continued success of our only approved product, ARIKAYCE, which was approved in the United States asproducts, ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product).BRINSUPRI. If we are unable to continue to successfully market andmarket, commercialize orand maintain approval for ARIKAYCE,ARIKAYCE and BRINSUPRI, our business, financial condition, results of operations and prospects and the value of our common stock willmay be materially adversely affected.

Our long-term viability and growth depend on the continued successful commercialization of ARIKAYCE,ARIKAYCE ourand only approved product.BRINSUPRI. ARIKAYCE was approved in the US for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting, as defined by patients who do not achieve negative sputum cultures after a minimum of six consecutive months of a multidrug background regimen therapy. Subsequently, ARIKAYCE was approved in Europe for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF, and in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatments with a multidrug regimen. We refer to NTM lung disease caused by MAC as MAC lung disease. BRINSUPRI was approved in the US in August 2025 as an oral, once-daily treatment for NCFB in adults and children 12 years and older, and in the EU in November 2025 for NCFB in adults and children 12 years or older with two or more exacerbations in the prior 12 months. We have invested and continue to invest significant efforts and financial resources in the commercialization of ARIKAYCE,ARIKAYCE and ourBRINSUPRI. Our ability to continue to generate revenue from ARIKAYCE will depend heavily on successfully commercializing and obtaining full regulatory approval for ARIKAYCE from the FDA by conducting an appropriate confirmatory post-marketing study. ARIKAYCEOur wasability ourto firstgenerate commercialrevenue launch,from andBRINSUPRI itswill continueddepend successfulheavily commercializationon andsuccessfully ourcommercializing receipt of full regulatory approval for ARIKAYCEBRINSUPRI in the US areand subjectthe toEU manyas risks.well as obtaining additional regulatory approvals outside of the US and the EU.

In order to continue to commercialize ARIKAYCE,ARIKAYCE and BRINSUPRI, we must continue to establish and maintain marketing, market access, sales and distribution capabilities on our own or make arrangements with third parties for its marketing, sale and distribution. We are commercializing ARIKAYCE in the US, Europe and Japan and BRINSUPRI in the US using our sales force, and we intend to use our sales force in any additional markets in which we commercialize BRINSUPRI, but we may not continue to be successful in these efforts. The establishment, development and maintenance of our own sales force is and will continue to be expensive and time-consuming. As a result, we may seek one or more partners to handle some or all of the sales and marketing of ARIKAYCE and/or BRINSUPRI in certain markets following approval by the relevant regulatory authority in those markets. In that case, we will be reliant on third parties to successfully commercialize ARIKAYCE and/or BRINSUPRI and will have less control over commercialization efforts than if we handled commercialization with our own sales force. However, we may not be able to enter into arrangements with third parties to sell ARIKAYCE and/or BRINSUPRI on favorable terms or at all. In the event that either our own marketing, market access, sales force or third-party marketing, and sales organizations are not effective, our ability to generate revenue would be adversely affected.

We may not be able to obtain regulatory approvals for brensocatib, or for our other product candidates and we may not be able to receive approval for ARIKAYCE in front-line NTM lung diseasedisease, for ARIKAYCE or BRINSUPRI in newadditional markets.markets or for our product candidates. Any such failure to obtain regulatory approvals, particularly for brensocatib,approvals may materially adversely affect us.

We are required to obtain various regulatory approvals prior to studying our products in humans and then again before we market and distribute our products, and the failure to obtain such approvals will prevent us from commercializing our products, which would materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock. While we have obtained accelerated approval for ARIKAYCE in the USUS, approval for ARIKAYCE in Europe and Japan and approval for BRINSUPRI in the EUUS and Japan,the EU, seeking regulatory approvals for brensocatib and any future regulatory approvals for our other product candidatescandidates, as well as approval for ARIKAYCE in front-line NTM lung disease or for ARIKAYCE or BRINSUPRI in other jurisdictions presents significant obstacles. Approval processes in the US, Europe, Japan and other markets require the submission of extensive preclinical and clinical data, manufacturing and quality information regarding the process and facility, scientific data characterizing our product and other supporting data in order to establish safety and effectiveness. These processes are complex, lengthy, expensive, resource intensive and uncertain. Regulators will also conduct a rigorous review of any trade name we intend to use for our products. Even after they approve a trade name, these regulators may request that we adopt an alternative name for the product if adverse event reports indicate a potential for confusion with other trade names and medication error. If we are required to adopt an alternative name, potential commercialization of brensocatib or our other product candidates could be delayed or continued commercialization of ARIKAYCE could be delayed or interrupted. We have limited experience in submitting and pursuing applications necessary to obtain these regulatory approvals.

Data submitted to regulators are subject to varying interpretations that couldmay delay, limit or prevent regulatory agency approval. Even if we believe our clinical trial results are promising, regulators may disagree with our interpretation of data, study design or execution and may refuse to accept our application for review or decline to grant approval.

In addition, the grant of aan orphan designation by the FDA or EMAEC or approval by the FDA, ECEC, MHRA or MHLW does not ensure a similar decision by the regulatory authorities of other countries, and a decision by one foreign regulatory authority does not ensure regulatory authorities in other foreign countries or the FDA will agree with the decision. For instance, although ARIKAYCE received orphan drug designation in the US,US for the treatment of infections caused by NTM, ARIKAYCE did not qualify for orphan drug designation in Japan due to the estimated number of NTM patients in Japan exceeding 50,000. Similarly, clinical studies conducted in one country may not be accepted by regulatory authorities in other countries. Approval procedures vary among countries and can involve additional product testing, including additional preclinicalpre-clinical studies or clinical trials, and administrative review periods. The time required to obtain approval in these other territories might differ from that required to obtain FDA approval. We may never obtain approval for brensocatib or for our other product candidates in the US or other jurisdictions, or for ARIKAYCE outside of the US, Europe and Japan, or for BRINSUPRI outside of the US and the EU, which would limit our market opportunities and may materially adversely affect our business. Even if brensocatibany orof anotherour product candidatecandidates is approved, or if ARIKAYCE is approved outside of the US, Europe and Japan, or if BRINSUPRI is approved outside of the US and the EU, regulators may limit the indications for which the product may be marketed, require extensive warnings on the product labelinglabeling, require other burdensome risk mitigation measures, such as distribution restrictions, or require expensive and time-consuming additional clinical trials or reporting as conditions of approval.

We may also encounter delays or rejections based on changes in regulatory agency policies or resources during the period in which we develop a product and the period required for review of any application for regulatory agency approval of a particular product. Resolving such delays couldmay force us or third parties to incur significant costs, limit our allowed activities or the allowed activities of third parties, diminish any competitive advantages that we or our third parties may attain or adversely affect our ability to receive royalties, any of which couldmay materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.

The commercial success of ARIKAYCE dependsand BRINSUPRI depend on continued market acceptance by physicians, patients, third-party payors and others in the healthcare communitycommunity, and the commercial success of brensocatib, TPIP, or our other product candidates, if approved, willmay similarly depend on market acceptance.

Despite receiving FDA, EC and Japan'sJapan’s MHLW approval of ARIKAYCE,ARIKAYCE and FDA and EC approval of BRINSUPRI for the specified indications, market acceptance may vary among physicians, patients, third-party payors or others in the healthcare community. ARIKAYCE was the first product approved in the US via the LPAD pathway,community and its approval under this pathway may impact market acceptance of the product. The degree of market acceptance of ARIKAYCE, which we launched in the US early in the fourth quarter of 2018, in Europe in the fourth quarter of 2020, and in Japan in the second quarter of 2021, is also dependent on a number of additional factors, including the following:

•The willingness of the target patient populations to use, and of physicians to prescribe, ARIKAYCE and BRINSUPRI;

•The efficacy and potential advantages of ARIKAYCE and BRINSUPRI over alternative treatments;

•The risk and safety profile of ARIKAYCE,ARIKAYCE and BRINSUPRI, including, among other things,things: with respect to ARIKAYCE, physician and patient concern regarding the US boxed warning and other safety precautions resulting from its association with an increased risk of respiratory adverse reactions,reactions; whether patients experience adverse events, including adverse events that did not occur or went undetected or unreported in our clinical trials; and any adverse safety information that becomes available as a result of longer-term use of ARIKAYCE and BRINSUPRI;

•The ability of the patient to tolerate ARIKAYCE and BRINSUPRI;

•The pricing of ARIKAYCE and BRINSUPRI;

•The ability and willingness of the patient to pay out of pocket costs for ARIKAYCE and BRINSUPRI (for exampleexample, co-payments);

Refer to Part I, Item 1. "Business" for a summarydetailed discussion of our ongoing commercial and clinical programs for ARIKAYCE and our ongoing clinical activities for brensocatib, TPIP, INS1201, and pre-clinical research programs.

Prior to 2019, we had not generated significant revenuerevenue, and through December 31, 2024,2025, we had an accumulated deficit of $4.4$5.6 billion. We have financed our operations primarily through the public offerings of our equity securities, debt financings and revenue interest financings. Although it is difficult to predict our future funding requirements, based upon our current operating plan, we anticipate that our cash and cash equivalents and marketable securities as of December 31, 20242025 will enable us to fund our operations for at least the next 12 months.

Our ability to reduce our operating loss and begin to generate positive cash flow from operations depends on the continued success in commercializing ARIKAYCEour marketed products and achieving positive results from the ARIKAYCE confirmatory clinical trial program in order to obtain full approval of ARIKAYCE in the US and potentially reach more patients. Our continued success also depends on commercializingobtaining brensocatib,regulatory ifapproval approved,for asbrensocatib wellin asan additional indication, bringing additional clinical stage products to market,products, such as TPIPTPIP, andINS1148, INS1201, and advancementINS1202, ofto market and advancing our pre-clinical research programs. We expect to continue to incur substantial expenses related to our research and development activities as we continue the ARIKAYCE confirmatory clinical program, conduct studies to explore the potential of brensocatib in additionalHS, neutrophil-mediatedconduct diseases,trials includingof CRSsNPTPIP in PH-ILD, PAH, PPF, and HS, continue the trials for TPIP,IPF, and fund development of our pre-clinical research programs. We also expect to continue to incur significant costs related to the commercialization of ARIKAYCE and our commercialmarketed readiness activities, and if approved, commercial activities in preparation for a launch of brensocatib for patients with bronchiectasis.products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of ARIKAYCEour marketed products; the scope and progress of our research and development efforts; and the timing of certain expenses. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when theywe may become profitable.

Product revenues, netnet, consist of net sales of ARIKAYCE. In October 2018, we began shipping ARIKAYCE to our customers in the US, which include specialty pharmacies and specialty distributors. In December 2020, we began commercial sales of ARIKAYCE in Europe. In July 2021, we began recognizing product revenue from commercial sales of ARIKAYCE in Japan.BRINSUPRI. We recognize revenue for product received by our customers net of allowances for customer credits, including prompt pay discounts, service fees, estimated rebates, including government rebates, such as Medicaid rebates and Medicare Part D coverage gap reimbursements in the US, and chargebacks.

Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE and BRINSUPRI sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses. We began capitalizing ARIKAYCE related inventory upon FDA approval of ARIKAYCE in September 2018.

R&D expenses consist of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in our research and development functions. R&D expenses also include other internal operating expenses, the cost of manufacturing product candidates, including the medical devices for drug delivery, for clinical study, the cost of conducting clinical studies, and the cost of conducting preclinicalpre-clinical and research activities. In addition, R&D expenses include payments to third parties for the license rights to products in development (prior to marketing approval), such as brensocatib, and may include the cost of asset acquisitions. Our R&D expenses related to manufacturing our product candidates and medical devices for clinical study are primarily related to activities at CMOs that manufacture brensocatib,our TPIP,product INS1201,candidates and pre-clinicalearly-stage research activities. Our R&D expenses related to clinical trials are primarily related to activities at contract research organizations (CROs) that conduct and manage clinical trials on our behalf. These contracts with CROs set forth the scope of work to be completed at a fixed fee or amountbilled perat patienta enrolled.per-unit cost, and increase proportionally to the volume of services rendered. Payments under these contracts with CROs primarily depend on performance criteria such as the successful enrollment of patients or the completion of clinical trial milestones as well as time-based fees. Expenses are accrued based on contracted amounts applied to the level of patient enrollment and to activity according to the clinical trial protocol. Deposits for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are then recognized as an expense as the related goods are delivered or the services are performed.

SG&A expenses consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnel serving in our executive, finance and accounting, legal and compliance, commercial and pre-commercial, corporate development, field sales, information technology and human resource functions. SG&A expenses also include professional fees for legal services, consulting services, including commercial activities, insurance, board of director fees, tax and accounting services and certain milestones related to ARIKAYCE.services.

Upon commercialization of ARIKAYCE,each ourof ARIKAYCE and BRINSUPRI, the related intangible assets began to be amortized over their estimated useful lives. The fair values assigned to our intangible assets are based on estimates and assumptions we believe are reasonable based on available facts and circumstances. Unanticipated events or circumstances may occur that require us to review the assets for impairment.

In connection with the Business Acquisition, we recorded deferred and contingent consideration liabilities related to potential future milestone payments. Adjustments to the fair value are due to changes in the probability of achieving milestones, our stock price, or certain other estimated assumptions. The change in fair value of deferred and contingent consideration liabilities is calculated quarterly with gains and losses recorded in the consolidated statements of comprehensive loss. Our deferred consideration liabilities were fully settled in the third quarter of 2024. As of December 31, 2025 and 2024, only contingent consideration liabilities exist.

We are a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Our commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement our internal research and development, we also actively evaluate in-licensing and acquisition opportunities for commercial products, product candidates, and technologies. For a more complete discussion of our business, strategy, products and pipeline, see Part I, Item 1, “Business,” of our Annual Report on Form 10-K for the year ended December 31, 2025.

Our two commercial products, ARIKAYCE and BRINSUPRI, are both part of theour Respiratory therapeutic area. ARIKAYCE is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg590 mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the EC approved ARIKAYCE Liposomal for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which we refer to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. We are not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe, or Japan.

BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In February 2026, the MHRA granted a marketing authorisation for BRINSUPRI (brensocatib 25 mg tablets) to treat patients 12 years and older with NCFB who have experienced two or more flare-ups or worsening of symptoms in the past 12 months. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. We are not aware of any other approved therapies in the US, Europe, or Japan for the treatment of patients with bronchiectasis.

Our Respiratory therapeutic area also includes the clinical-stage programs TPIP and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD, PAH, PPF, and IPF. INS1148 is a monoclonal antibody targeting SCF248, which we plan to initially develop for PPF and IPF. We are exploring additional opportunities utilizing our various technologies within the Respiratory therapeutic area.

The clinical-stage programs in our Neuro & Other Rare therapeutic area are INS1201, an intrathecally delivered gene therapy for patients with DMD, and INS1202, an intrathecally delivered gene therapy for patients with ALS. We are exploring additional opportunities utilizing our various technologies within the Neuro & Other Rare therapeutic area.

OurWe pre-clinicalare research programs encompassadvancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue.rescue, in the pursuit of future pipeline candidates.

Prior to 2019, we had not generated significant revenue and, through MarchJune 31,30, 2026, we had an accumulated deficit of $5.8 billion. We have financed our operations primarily through the public offerings of our equity securities, debt financings and revenue interest financings. Although it is difficult to predict our future funding requirements, based upon our current operating plan, we anticipate that our cash and cash equivalents and marketable securities as of MarchJune 31,30, 2026 will enable us to fund our operations for at least the next 12 months.

The information below summarizes our recent updates and anticipated near-term milestones for our marketed products and our product candidates.

•We continue to anticipate a regulatory decision for brensocatib for the treatment of NCFB in Japan in the second half of 2026.

•WeIn anticipateJuly submitting2026, we submitted a US supplemental new drug application (sNDA) for ARIKAYCE in allnewly diagnosed patients with MAC lung disease in the second half of 2026.disease. We also plan to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan in the second half of 2026.Japan.

•We initiated PALM-ILD, aour Phase 3 study of TPIP in patients with PH-ILD,PH-ILD that we initiated in the fourth quarter of 20252025, andcontinues areto actively enrollingenroll patients.

•WeIn anticipateApril initiating2026, awe initiated the Phase 3 PALM-PAH study of TPIP in patients with PPF in the second half of 2026PAH and aare Phaseactively 3enrolling study in patients with IPF in the first half of 2027.patients.

•We plancontinue to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and we are exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.