Form 8-K

8-K — INSMED Inc

Accession: 0001140361-26-028602

Filed: 2026-07-16

Period: 2026-07-16

CIK: 0001104506

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ef20078093_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20078093_ex99-1.htm)

EX-99.2 — EXHIBIT 99.2 (ef20078093_ex99-2.htm)

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8-K

8-K (Primary)

Filename: ef20078093_8k.htm · Sequence: 1

false0001104506NASDAQ00011045062026-07-162026-07-16

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 16, 2026

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

Virginia

000-30739

54-1972729

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

700 US Highway 202/206

Bridgewater, New Jersey

08807

(Zip Code)

(Address of principal executive offices)

Registrant’s telephone number, including area code: (908) 977-9900

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following

provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common Stock, par value $0.01 per share

INSM

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the

Securities Exchange Act of 1934 (17 CFR 240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised

financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

ITEM 7.01 —

Regulation FD Disclosure.

On July 16, 2026, Insmed Incorporated (the “Company”) issued a press release announcing 12-month safety and efficacy data from its ongoing open-label extension study of treprostinil palmitil inhalation powder in patients with

pulmonary arterial hypertension (the “OLE Study”). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The Company will host a conference call to discuss the 12-month data of the OLE Study on July 16, 2026, at 8:00 a.m., Eastern Time, and a live webcast of

the call will be available through the investor relations section of the Company’s website. A copy of the slide presentation to be used by the Company during the conference call is attached hereto as Exhibit 99.2 and incorporated herein by reference.

The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities

Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

ITEM 9.01 —

Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release issued by Insmed Incorporated on July 16, 2026.

99.2

Insmed Incorporated July 16, 2026 12-Month OLE Study Presentation

104

Cover Page Interactive Date File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the

undersigned hereunto duly authorized.

Dated: July 16, 2026

INSMED INCORPORATED

By:

/s/ Michael A. Smith

Name:

Michael A. Smith

Title:

Chief Legal Officer and Corporate Secretary

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20078093_ex99-1.htm · Sequence: 2

Exhibit 99.1

Insmed Announces Positive 12-Month Data from the Ongoing Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients

with Pulmonary Arterial Hypertension

–12-Month Data Demonstrated Sustained Improvement with TPIP Across All Secondary

Efficacy Measures Including Reduction in Mortality Risk Status by REVEAL Lite 2.0–

–Placebo Crossed Group Demonstrated Treatment Response on TPIP, Achieving Similar Outcomes to the TPIP Continued Group by Month 12–

–TPIP Was Safe and Well-tolerated with No Newly Identified Safety Signals through Month 12; Doses Up to 1,280 µg Once Daily Were

Permitted in the OLE Study–

–These OLE Data,

Combined with Once-Daily Inhaled Administration, Reinforce TPIP’s Potential to Become the Prostanoid of Choice for Patients with PAH–

–Insmed to Host

Investor Call Thursday, July 16, 2026, at 8:00 a.m. ET–

BRIDGEWATER, N.J., July 16, 2026 -- Insmed Incorporated (Nasdaq:INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class

therapies to transform the lives of patients facing serious diseases, today announced positive 12-Month data from the ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP), administered once daily in

patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1). The OLE study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP over 24 months in

patients who completed the lead-in TPIP PAH studies.

"These data from our ongoing OLE study with TPIP represent an important milestone in our efforts to fully

harness the potential of treprostinil and provide meaningful benefit to patients with pulmonary arterial hypertension," said Gene Sullivan, M.D., Chief Product Strategy Officer of Insmed. “In this analysis, TPIP demonstrated sustained improvement across all efficacy endpoints and was well tolerated with no newly identified safety signals, and notably, patients who switched from placebo to TPIP in the OLE study

achieved similar clinical benefit. These data, coupled with the statistically significant and clinically meaningful results from our Phase 2b randomized study, demonstrate TPIP's potential to become the prostanoid of choice for PAH patients,

and we remain excited to be advancing our Phase 3 PALM-PAH study."

12-Month Results from the Ongoing OLE Study with TPIP in Patients with PAH

Results for secondary efficacy endpoints demonstrated sustained improvement with TPIP in six-minute walk distance (6MWD), N-terminal fragment pro-B-type natriuretic

peptide (NT-proBNP) concentration, and World Health Organization (WHO) Functional Class, as well as a clinically meaningful improvement in REVEAL Lite 2.0 score at Month 12. Patients in the Placebo Crossed group (N=31) showed similar outcomes to

patients in the TPIP Continued group (N=60) across all efficacy measures at Month 12.

The results at Month 12 were as follows:

•

Mean improvement from baseline for 6MWD was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group.

•

NT-proBNP concentration was reduced by approximately 60% in both groups with geometric mean ratios [GMR] to baseline of 0.40 and 0.41 in TPIP Continued and Placebo Crossed, respectively.

•

WHO Functional Class I or II was achieved in 78.3% of TPIP Continued group and 80.6% of Placebo Crossed group patients, and more than 25% of patients across both groups achieved WHO Functional

Class I.

•

Mean REVEAL Lite 2.0 score improved 2.0-points from baseline for the TPIP Continued group and 1.4-points from baseline for the Placebo Crossed group. Approximately 65% of all patients achieved

Refined Low Risk status, which is associated with a less than 5% estimated risk of mortality at three years and an approximately 7% risk of clinical worsening at one year.

"Pulmonary arterial hypertension is one of the most devastating diseases we face as clinicians, and these results from the ongoing TPIP OLE study give us genuine reason

for optimism,” said Dr. Raymond Benza, M.D., F.A.C.C., FAHA, FACP, Phase 2b PAH study Steering Committee Member, George M. and Linda H. Kaufman Academic Chair of Cardiology, Sentara Health. “The REVEAL Lite 2.0 risk score provides a powerful,

non-invasive way to track disease trajectory. Previous REVEAL Lite 2.0 validation showed that a 1-point score improvement reduces risk of mortality by 23% and reduces the risk of clinical worsening by 21%. Here we saw that patients on TPIP

averaged a greater than 1-point improvement from baseline, which is really meaningful for patients. Sustained improvements of this magnitude, alongside gains in exercise capacity and Functional Class, provide a strong clinical rationale to

advance this therapy into Phase 3 development."

Results for the primary endpoint of safety & tolerability showed that once-daily TPIP therapy was generally well tolerated with no newly identified safety signals

at doses up to 1,280 µg through Month 12. Of the 91 patients in the study, treatment-emergent adverse events (TEAEs) occurred in 89.0% of patients; serious TEAEs were observed in 18.7% of patients; and severe TEAEs were observed in 16.5% of

patients in the study. TEAEs leading to study discontinuation were experienced by 7.7% of patients. There were four deaths, none of which were considered related to TPIP treatment. The most common TEAEs through Month 12 occurring in 5.0% or more

of all patients were headache (28.6%), cough (15.4%), nasopharyngitis (14.3%), diarrhea (11.0%), upper respiratory tract infection (9.9%), bronchitis (7.7%), dizziness (6.6%), epistaxis (6.6%), nausea (6.6%), anemia (5.5%), influenza (5.5%), and

pneumonia (5.5%).

The 12-Month OLE findings support the continued clinical development of TPIP and the recent initiation of PALM-PAH, a Phase 3, randomized, double-blind,

placebo-controlled trial evaluating once-daily TPIP in patients with PAH over 24 weeks. The primary endpoint of PALM-PAH is change in 6MWD, with additional assessments of safety, tolerability, and overall efficacy. Insmed plans to publish the

12-Month results from this OLE study in the future. Topline results from the Phase 2b study of TPIP in patients with PAH were previously reported in June 2025.

Conference Call Information

Insmed management will host a conference call for investors beginning at 8:00 a.m. ET on Thursday, July

16, 2026, to discuss the TPIP OLE study results. Shareholders and other interested parties may participate in the conference call by dialing (800) 715-9871 (U.S.) or +1 (646) 307-1963 (International) and referencing access code 2033335. The

call will also be webcast live on the Company's website at www.insmed.com.

A replay of the conference call will be accessible approximately one hour after its completion through July 23, 2026, by dialing (800) 770-2030 (U.S. and Canada) or +1

(609) 800-9909 (International) and referencing access code 2033335. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an

ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as a once-daily therapy for the treatment of patients with PAH, pulmonary hypertension associated

with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation device. TPIP is an

investigational drug product that has not been approved for any indication in any jurisdiction.

About the TPIP Open-Label Extension Study

The 24-month open-label extension (OLE) study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) was designed to

evaluate the long-term safety, tolerability, and effectiveness of TPIP administered once daily in patients who completed the lead-in TPIP PAH studies. The OLE is being conducted at 45 sites globally and enrolled 91 eligible patients. The study included a 3-week blinded titration period followed by open-label treatment. Patients who received TPIP in the lead-in studies (TPIP Continued) received their achieved dose of TPIP;

patients who received placebo in the lead-in studies (Placebo Crossed), or had delayed rollover, underwent titration starting at 80 µg once daily up to their target dose (i.e., 640 µg or

highest tolerated dose) over three weeks. Further escalation up to 1,280 µg was permitted after the initial titration period at investigator discretion to optimize clinical benefit. Outcomes were evaluated against the Phase 2b lead-in study in

PAH (NCT05147805) pre-randomization baseline values for relevant measurements.

The primary endpoint is evaluating long-term safety and tolerability, including treatment-emergent adverse events (TEAEs) and TEAEs by severity. Secondary endpoints

include change from lead-in study pre-randomization baseline in six-minute walk distance (6MWD), N-terminal fragment pro-B-type natriuretic peptide (NT-proBNP) concentration, World Health Organization (WHO) Functional Class, REVEAL Lite 2.0

score, and additional exploratory measures over 24 months of treatment.

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood

pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness. It is estimated that approximately 35,000 patients in the U.S., 40,000 patients in the EU5

(France, Germany, Italy, Spain, and the UK), and 15,000 patients in Japan have been diagnosed with the disease. Untreated PAH can be debilitating and often fatal.

About Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing

serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines—including two approved therapies to treat chronic, debilitating lung diseases—as well as cutting-edge drug discovery

focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The

Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as

one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to

learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the

Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates,"

"believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties

and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or

indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that the full data set from the OLE study of TPIP in PAH (the “Study”) or data generated in further clinical

trials of TPIP will not be consistent with the interim results of the Study; the risk that data from the Study, which is conducted in a single-arm, open-label design without a concurrent placebo control group, may not be predictive of, or may

differ materially from, results obtained in the Phase 3 PALM-PAH randomized, double-blind, placebo-controlled trial; the risk that the Study’s efficacy endpoints, which are secondary and exploratory in nature, may overestimate or otherwise not

accurately reflect the true treatment effect of TPIP; failure to successfully conduct future clinical trials for TPIP, such as the Company’s planned Phase 3 program for TPIP, including due to the Company's potential inability to enroll or retain

sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is

dependent to manufacture sufficient quantities of TPIP for clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the

Company; failure to obtain regulatory approval for TPIP; inaccuracies in the Company's estimates of the size of the potential markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of

expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability

to obtain adequate reimbursement from government or third-party payors for TPIP or acceptable prices for TPIP, if approved; restrictions or other obligations imposed on the Company by agreements related to TPIP and failure to comply with the

Company’s obligations under such agreements; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; the strength and enforceability of the Company’s intellectual property

rights or the rights of third parties; and the cost and potential reputational damage resulting from litigation to which the Company may become a party, including product liability claims.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature,

forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the

Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission

(SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company

disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such

statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:

Bryan Dunn

Vice President, Investor Relations

(646) 812-4030

investor.relations@insmed.com

Media:

Claire Mulhearn

Vice President, Corporate Communications

(862) 842-6819

media@insmed.com

EX-99.2 — EXHIBIT 99.2

EX-99.2

Filename: ef20078093_ex99-2.htm · Sequence: 3

Exhibit 99.2

July 16, 2026 12-Month Results from Ongoing Open-Label Extension Study of TPIP in

PAH Patients TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension

Forward Looking Statements The forward-looking statements in this presentation

are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to

differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the

risk that the full data set from the OLE study of TPIP in PAH (the “Study”) or data generated in further clinical trials of TPIP will not be consistent with the interim results of the Study; the risk that data from the Study, which is conducted

in a single-arm, open-label design without a concurrent placebo control group, may not be predictive of, or may differ materially from, results obtained in the Phase 3 PALM-PAH randomized, double-blind, placebo-controlled trial; the risk that

the Study’s efficacy endpoints, which are secondary and exploratory in nature, may overestimate or otherwise not accurately reflect the true treatment effect of TPIP; failure to successfully conduct future clinical trials for TPIP, such as the

Company’s planned Phase 3 program for TPIP, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things;

development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is dependent to manufacture sufficient quantities of TPIP for clinical needs, to conduct the Company's clinical trials, or to

comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; failure to obtain regulatory approval for TPIP; inaccuracies in the Company's estimates of the size of the potential

markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or

the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability to obtain adequate reimbursement from government or third-party payors for TPIP or acceptable prices for TPIP, if approved;

restrictions or other obligations imposed on the Company by agreements related to TPIP and failure to comply with the Company’s obligations under such agreements; risks that the Company's clinical studies will be delayed or that serious side

effects will be identified during drug development; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; and the cost and potential reputational damage resulting from litigation to which

the Company may become a party, including product liability claims. Additional Disclaimers: Please be aware that TPIP is an investigational product that has not been approved for sale or found safe or effective by the FDA or any regulatory

authority. This presentation is not promotion or advertisement of TPIP. TPIP: treprostinil palmitil inhalation powder | FDA: Food & Drug Administration

Opening Remarks Study Results KOL Reflection Closing

Remarks 5-7 9-18 19 20-21 Will Lewis Chair & CEO Gene Sullivan Chief Product Strategy Officer KOL: key opinion leader Dr. Raymond Benza George M. and Linda H. Kaufman Academic Chair of Cardiology, Sentara Health

Opening Remarks Will Lewis | Chair & CEO

TPIP: Investigational Once-Daily Prostanoid with the Potential to Deliver

Best-in-Class† Efficacy with Enhanced Tolerability TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension | PH-ILD: pulmonary hypertension due to interstitial lung disease | * Analysis based on safety and

tolerability data from the Phase 2a PH-ILD published May 2024, and the Phase 2b PAH study published June 2025 | ** No head-to-head or convenience studies have been conducted or planned | † “Best-in-disease/best-in-class" indicates a profile

that could be considered more attractive than other treatment options for a particular disease. Head-to-head clinical trials are not anticipated. Potential Advantages of TPIP Efficacy* Inhaled therapy delivered directly to the lung

tissue Slow-release properties enable high, consistent treprostinil levels in lungs Flexibility to titrate up to patient max tolerated dose in pursuit of optimal therapeutic benefit Safety* Potential for reduced systemic side effects due to

lower peak exposure Inert pro-drug formula may improve tolerability Shown preclinically to reduce cough vs. active drug of the same dose Convenience** Administered once daily vs. the 4-times per day of other approved inhaled

treprostinils 1-2 breaths per day (even for 1,280 µg dose) Less frequent dosing may improve patient adherence to therapy

TPIP: treprostinil palmitil inhalation powder | PVR: pulmonary vascular resistance

| 6MWD: 6-minute walk distance | NT-proBNP: N-terminal pro b-type natriuretic peptide | TEAEs: treatment emergent adverse events | 1 Analysis performed using an ANCOVA model, adjusting for treatment group, baseline PVR, and randomization

stratification factors. The model was applied to log-transformed PVR values, which were then back-transformed to the original scale | 2 Covariate-adjusted estimate of location shift. Analysis performed using a rank ANCOVA model, adjusting for

treatment group, baseline 6MWD, and randomization stratification factors | 3 Analysis performed using a repeated measures mixed model, adjusting for treatment group, baseline NT-proBNP, randomization stratification factors, visit and

treatment-by-visit interaction. The model was applied to log-transformed NT-proBNP values, which were then back-transformed to the original scale. | ‡ Nominal p-value not adjusted for multiplicity Phase 2b Study Illustrated TPIP’s Competitive

Efficacy and Safety Profile 6-Minute Walk Distance (6MWD) Placebo-Adjusted Improvement2 at Week 16 Nominally statistically significant‡ +35.5 meters Safety & Tolerability 90% study completion TEAEs consistent with inhaled

treprostinil profile All incidences of cough were reported as mild or moderate Pulmonary Vascular Resistance (PVR) 35% Placebo-Adjusted Reduction1 at Week 16 Highly statistically significant Efficacy results far exceed those of other

therapies in the prostacyclin class Measured ~24 Hours After Dose Measured ~24 Hours After Dose NT-proBNP Concentration Placebo-Adjusted Reduction3 at Week 16 Nominally statistically significant‡ ~60% Measured ~24 Hours After Dose

12-Month OLE Results: Sustained Improvement Across All Efficacy Measures Including

pro-B-type natriuretic peptide | 1 Measured approximately 24-hours after prior dose was administered | 2 The REVEAL Lite 2.0 (or REVEAL Lite 2) risk calculator is a simplified, non-invasive medical tool used to estimate the mortality and

disease progression risk for adult patients with PAH | Note: OLE study outcomes were evaluated against the Phase 2b lead-in study (NCT05147805) pre-randomization baseline value for relevant measurements Patients who continued TPIP

showed: Sustained improvement in 6MWD1 Sustained improvement in NT-proBNP1 Further improvement in WHO Functional Class Clinically meaningful improvement in REVEAL Lite 2.0 Score2 Patients who crossed from placebo to TPIP showed

similar outcomes to those that continued therapy across all efficacy measurements

Study Results Gene Sullivan | Chief Product Strategy Officer

Open-Label Extension Intended to Evaluate TPIP’s Long-Term Safety &

Tolerability Over 24 Months Safety and tolerability (frequency & severity of TEAEs) Change from baseline in exercise capacity (6MWD)* Change from baseline in biomarkers of cardiac stress (NT-proBNP)* Proportion of patients that improved

WHO Functional Class vs. baseline Change from baseline REVEAL Lite 2.0 Score** Key OLE Study Endpoints Proportion of patients who achieve a REVEAL Lite 2.0 Low Risk status Proportion of patients with improvement in the REVEAL Lite 2.0 Risk

status Primary Endpoint Secondary Endpoints Exploratory Endpoints OLE: open-label extension | PAH: pulmonary arterial hypertension | TPIP: treprostinil palmitil inhalation powder | TEAE: treatment-emergent adverse event | 6MWD: 6-minute

medical tool used to estimate the mortality and disease progression risk for adult patients with PAH | *** Double-dummy titration was used to maintain blinding and permit patients who received TPIP in the lead-in studies (“TPIP Continued”) to

receive their achieved dose of TPIP at the start of the OLE. Patients who received placebo in the lead-in study (“Placebo Crossed”) or had delayed rollover underwent titration starting at 80 µg once daily up 640 µg or highest tolerated dose.

After Week 3, most patients maintained a stable TPIP dose. Investigators are permitted to titrate up to 1,280 µg to optimize treatment benefit after Week 3 of the study. | † Lead-in studies include the Phase 2b study (NCT05147805), which

contributed 90 patients, and the Phase 2a 24-hour PVR study (NCT04791514), which contributed 1 patient (study was discontinued). Pre-randomization baseline values are not available for the single PVR study participant. | ‡ OLE study outcomes

were evaluated against the Phase 2b lead-in study pre-randomization baseline values for relevant measurements | ^ Patients located in Japan will remain in the OLE for 84 months in accordance with Japan-specific protocol 4 weeks 24 months Day

1 of OLE End of OLE^ 16 weeks Follow-up Lead-in Studies† 3-week titration period*** Month 24 of OLE Baseline‡ Month 12 of OLE TPIP 80-1,280 µg inhalation capsules once daily Open-Label Treatment Period*** 91 patients

enrolled in the OLE

Baseline† Characteristics Were Comparable Across Groups Continued

TPIP1N=60 Placebo Crossed2N=31 Total N=91 Age: Mean, years 47.9 47.6 47.8 Sex: Male, % (n) 13.3% (8) 19.4% (6) 15.4% (14) Geographic Region: % (n) United States 10.0% (6) 9.7% (3) 9.9% (9) Europe 36.7% (22) 35.5%

(11) 36.3% (33) Rest of World 53.3% (32) 54.8% (17) 53.8% (49) PAH Subtype (Idiopathic)*: % (n) 66.7% (40) 67.7% (21) 67.0% (61) PAH Medications*: % (n) 1 23.3% (14) 9.7% (3) 18.7% (17) 2 75.0% (45) 90.3% (28) 80.2%

(73) 6MWD*: Mean (SD), meters 355.1 (79.00) 369.5 (61.73) 360.1 (73.48) NT-proBNP*: Mean (SD), pg/mL 787.5 (1,193.2) 795.8 (1,042.1) 790.4 (1,137.5) WHO Functional Class*: % (n) Class II 61.7% (37) 67.7% (21) 63.7% (58) Class

III 36.7% (22) 32.3% (10) 35.2% (32) REVEAL Lite 2.0 Status*: % (n) Low (Score ≤5) 51.7% (31) 58.1% (18) 53.8% (49) Refined Low (Score ≤4) 35.0% (21) 51.6% (16) 40.7% (37) Intermediate (Score 6-7) 25.0% (15) 22.6% (7) 24.2%

(22) High (Score ≥8) 21.7% (13) 19.4% (6) 20.9% (19) PAH: pulmonary arterial hypertension | 6MWD: 6-minute walk distance | NT-proBNP: N-terminal pro-B-type natriuretic peptide, a biomarker of cardiac stress | WHO: World Health Organization

| REVEAL Lite 2.0 risk calculator is a simplified, non-invasive medical tool used to estimate the mortality and disease progression risk for adult patients with PAH | N/n: number of patients | pg/mL: picograms per milliliter | 1 Includes all

rollover patients randomized to TPIP in the Phase 2b study (NCT05147805) and 1 participant from Phase 2a 24-hour PVR study (NCT04791514) | 2 Includes all rollover patients randomized to placebo in Phase 2b study | * Single participant from the

Phase 2a 24-hour PVR study had missing baseline data | † All baseline characteristics presented reflect values from both lead-in studies unless otherwise noted | Note: WHO Functional Class and number of baseline medications were stratification

factors in the Phase 2b lead-in study’s prespecified statistical analysis plan (SAP) | Note: All patients were on at least one background PAH medication

91% of OLE Patients Remained on TPIP at Month 12 OLE: open-label extension |

study of TPIP in PAH (NCT05147805) and 1 patient from the Phase 2a 24-hour PVR study (NCT04791514) | 2 Includes all rollover patients randomized to placebo in the Phase 2b study Phase 2b Study of TPIP in PAH N=62 (TPIP) and N=33 (placebo)

completed 24-Hour PVR Study N=1 (TPIP)* 24-Month OLE Study of TPIP in PAH N=91 Continued TPIP 1 N=60 Placebo Crossed2 N=31 12-Month OLE Analysis Lead-in Studies: N=83 95% of completers enrolled in OLE (N=90) 91% Patient

Completion Treatment Groups:

TPIP was Generally Safe and Well-Tolerated;No Newly Identified Safety Signals

Through Month 12 SAFETY Total (N=91) % n Any TEAE 89.0% 81 ≤640 µg Max Dose Achieved 86.1% 62 >640 µg Max Dose Achieved** 89.5% 17** Serious 18.7% 17 ≤640 µg Max Dose Achieved 20.8% 15 >640 µg Max Dose

Achieved** 10.5% 2** Study Drug Related 1.1% 1† Leading to Death 4.4% 4‡ Severe 16.5% 15 Leading to Study Discontinuation*** 7.7% 7 Leading to Dose Reduction 11.0% 10 Study Drug Related 35.2% 32 TPIP: treprostinil

tolerated dose exceeded 640µg and whose adverse event occurred at a dose level that exceeded 640µg | ***All participants who discontinued treatment also discontinued study | † Patient from the Phase 2b lead-in study was hospitalized with

orthostatic hypotension and subsequently discharged after precautionary workup was completed (patient discontinued their anti-hypertensive agent). Primary investigator assessed this event as study drug related | ‡ Location of participant

deaths: 1 Argentina (myocardial infarction), 2 Philippines (acute respiratory failure, hypovolemic shock), 1 United States (single patient from the Phase 2a 24-hour PVR study died of acute respiratory distress syndrome in the setting of

pneumonia during titration period after being off TPIP therapy for ~18 months) | Note: TEAEs reported in this table are only those that emerged during the OLE, not during the lead-in studies MOST COMMON TEAEs*, % (n) Headache 28.6%

(26) Dizziness 6.6% (6) Cough 15.4% (14) Epistaxis 6.6% (6) Nasopharyngitis 14.3% (13) Nausea 6.6% (6) Diarrhea 11.0% (10) Anemia 5.5% (5) Upper Respiratory Tract Infection 9.9% (9) Influenza 5.5%

(5) Bronchitis 7.7% (7) Pneumonia 5.5% (5) 19 patients (21%) achieved >640 µg dose No deaths or study drug related SAEs; No TEAEs led to study discontinuation** Only 1 cough TEAE was reported** >640 µg Max Dose Achieved by

Month 12 None of the 4 deaths were considered study drug related All TEAEs of cough were classified as mild or moderate, with >85% being mild

Patients that Continued on TPIP Showed Sustained Improvement in 6MWD Over 12

Months Change from Baseline* 6MWD† (SE), meters Lead-in Study Baseline* Week 16 Ph2b Study / Day 1 OLE Study‡ Month 6 OLE Study Month 12 OLE Study +55.7 Continued TPIP meters +54.1 Placebo Crossed meters Mean Improvement from

Baseline* 6MWD at Month 12 Patients who crossed from placebo to TPIP achieved 6MWD improvement outcomes nearly in-line with those of continuing TPIP patients at Month 12 TPIP: treprostinil palmitil inhalation powder | 6MWD: 6-minute walk

distance, measured approximately 24-hours after prior dose was administered | OLE: open-label extension | SE: standard error | Ph: Phase | * Phase 2b lead-in study pre-randomization baseline values. Phase 2a 24-hour PVR study single patient

data were not included in change from baseline analysis as no baseline was available. | † Last observation carried forward (LOCF) is used to impute the missing values at each visit | ‡ Day 1 OLE values are the same as the Phase 2b lead-in study

Week 16 values for patients who rolled over into the OLE study within 7 days of completion. Continued TPIP Placebo Crossed Median - Continued TPIP Median - Placebo Crossed Mean - Placebo Crossed Mean - Continued TPIP Phase 2b Study

Patients that Continued on TPIP Showed Sustained Reduction in NT-proBNP Over 12

Months Geometric Mean Ratio to Baseline* NT-proBNP Concentration† (SE) Mean Reduction from Baseline* NT-proBNP Concentration at Month 12 TPIP: treprostinil palmitil inhalation powder | NT-proBNP: N-terminal pro-B-type natriuretic

peptide, measured approximately 24-hours after prior dose was administered | OLE: open-label extension | SE: standard error | Ph: Phase | * OLE study outcomes were evaluated against the Phase 2b lead-in study pre-randomization baseline value

for relevant measurements | † Last observation carried forward (LOCF) is used to impute the missing value at each visit | ‡ Day 1 values are the same as the Phase 2b lead-in study Week 16 values for patients who rolled over into the OLE within

7 days of completion. | Note: Phase 2a 24-hour PVR study single patient data were not included in change from baseline analysis as no baseline was available Patients from both groups achieved an ~60% mean reduction in NT-proBNP levels by Month

6 and maintained these levels at Month 12 Continued TPIP Placebo Crossed ~60% Continued TPIP ~60% Placebo Crossed Phase 2b Study Lead-in Study Baseline* Week 16 Ph2b Study / Day 1 OLE Study‡ Month 6 OLE Study Month 12 OLE Study

Lead-in Study Baseline* Month 6 OLE Study Month 12 OLE Study Both Groups

Showed Meaningful Improvement in WHO Functional Class (FC) by Month 12 Continued TPIP (N=60) Placebo Crossed (N=31) Proportion of Patients† ~80% of all patients achieved FC I or II Functional Class by Month 12 >25% of all patients

*OLE study outcomes were evaluated against the Phase 2b lead-in study pre-randomization baseline value for relevant measurements | † Figure proportions are based on the number of patients in the full analysis set within that treatment group

including patients with missing data | ‡ Day 1 values are the same as the Phase 2b lead-in study Week 16 values for patients who rolled over into the OLE within 7 days of completion. | Note: Phase 2a 24-hour PVR single patient did not have

baseline data for WHO Functional Class Phase 2b Study Lead-in Study Baseline* Month 6 OLE Study Month 12 OLE Study Phase 2b Study W16 Ph2b / Day 1 OLE‡ W16 Ph2b / Day 1 OLE‡ 50% of patients in the Continued TPIP group and 42% of

the Placebo Crossed group improved by at least one FC category by Month 12

Scoring Components† REVEAL Lite 2.0 Score: Simplified, Non-invasive, Validated

Tool to Estimate the Mortality Risk of PAH Patients Scoring1,2 Points Estimated Mortality Risk Estimated Morbidity Risk3 High Risk ≥ 8 >10% at 1 year Intermediate Risk 6 – 7 ~5-10% at 1 year Low Risk ≤ 5 ~1-5% at 1 year ~12%

at 1 year Refined Low Risk4 ≤ 4 <5% at 1 & 3 years ~7% at 1 year A 1-point improvement from baseline REVEAL score is associated with a ~23% reduction in risk of death and ~21% reduction in clinical worsening (morbidity)1,2,3 PAH:

pulmonary arterial hypertension | NT-proBNP: N-terminal pro-B-type natriuretic peptide (BNP); a biomarker of cardiac stress | WHO: World Health Organization | NYHA: New York Heart Association | 1 Benza RL, Boucly, A., Farber, HW, et al, “Change

in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in PATENT study.” Journal of Heart and Lung Transplantation, 2022, 41(3), 412-420 | 2 Benza RL, Gomberg-Maitland M, Elliott, CG et al, “Development

and validation of an abridged version of the REVEAL Lite 2.0 Risk Score Calculator, REVEAL Lite 2, for use in patients with pulmonary arterial hypertension. Chest 2021; 159 (1); 337-346 | 3 Morbidity, or clinical worsening, is defined by any of

the following: lung transplantation, hospitalization for PAH, initiation of long-term oxygen therapy, 15% decrease in 6-minute walking distance (6MWD) from baseline with a worsening of NYHA functional class, or the addition of a new PAH

medication. | 4 Fauvel, C., Correa Jaque, P, Liu Y, Lee SW, et al, “Refining the definition for “Low Risk” in Pulmonary Arterial Hypertension – Time to reduce morbidity and mortality.” JACC: Heart failure, 2026 | † A minimum of three scoring

components (variables) are required to generate a score where at least two are most predictive variables (denoted by *) NYHA / WHO Functional Class* 6-Minute Walk Distance Test* Renal Insufficiency Heart Rate Systolic Blood Pressure BNP

/ NT-proBNP Concentration*

Both Groups Showed Clinically Meaningful Improvement in Mean REVEAL Lite 2.0 Score

by Month 12 Mean REVEAL Lite 2.0 Score (SE)† ~65%** of all patients achieved Refined Low Risk status by Month 12 REVEAL Score Improvement by Month 12 TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension |

observation carried forward (LOCF) is used to impute the missing value at each visit | ‡ Day 1 values are the same as the Phase 2b lead-in study Week 16 values for patients who rolled over into the OLE within 7 days of completion. | Note: The

REVEAL Lite 2.0 (or REVEAL Lite 2) risk calculator is a simplified, non-invasive medical tool used to estimate the mortality and disease progression risk for adult patients with PAH. The score can be calculated if at least two of the most

predictive variables and at least three variables in total are available. | Note: Phase 2a 24-hour PVR study single patient did not have baseline REVEAL data but did have Day 1 OLE observed data and LOCF imputed data for Month 6 and Month

12 Refined Low Risk Status Low Risk Status Intermediate Risk Status (>5 to <8) Phase 2b Study Continued TPIP Placebo Crossed Lead-in Study Baseline* Week 16 Ph2b Study / Day 1 OLE Study‡ Month 6 OLE Study Month 12 OLE

Study Continued TPIP Placebo Crossed 2.0 points 1.4 points

RCT: randomized clinical trial | PAH: pulmonary arterial hypertension | TPIP:

is included because it represents the largest reduction in PVR achieved by sotatercept in a published randomized placebo-controlled clinical trial | Note: A lead-in study may also be referred to as a parent study in different OLE designs |

Note: Cross-trial comparisons are inherently limited and should be interpreted with caution. Differences in study design, patient populations, and prespecified statistical analysis plans may affect comparability. | Note: Numbered footnotes

referenced on this slide can be found in the appendix of this presentation | Note: Tyvaso and Winrevair are trademarks of their respective owners TPIP’s Profile Could Represent a Compelling Option in the Evolving PAH Treatment Landscape RCT

(16 weeks) OLE (12 months) RCT (12 weeks) OLE (12 months) RCT(24 weeks) OLE (SOTERIA) (12 months)12 Phase 2b (Lead-in) Continued Treatment Placebo Crossed X Phase 3 TRIUMPH (Lead-in) Continued Treatment Placebo Crossed X Ph2

PULSAR** or Ph3 STELLAR (Lead-ins)12 Continued Treatment Placebo Crossed PVR -35%1 N/A N/A X N/A N/A N/A X -34%** (0.7 mg dose)13 N/A N/A 6MWD (meters) +35.52 +55.73 vs. lead-in baseline +54.13 vs. lead-in

baseline X +208 +389 vs. lead-in baseline +259 vs. lead-in baseline X +4114 -1.715 vs. OLE baseline* +4715 vs. OLE baseline* NT-proBNP (pg/mL) -60%4 -60%5 vs. lead-in baseline -60%5 vs. lead-in

baseline X -18710 N/A N/A X -44216 -3317 vs. OLE baseline* -82717 vs. OLE baseline* Functional Class 30% of patients on treatment improved WHO FC6 ~80% of OLE patients achieved FC I or II7 X No difference in NYHA FC between

groups11 N/A N/A X 29% of patients on treatment improved WHO FC18 ≥80% of OLE patients achieved FC I or II19 TPIP Investigational product that has not been approved for sale or found safe or effective by the FDA or any regulatory

authority

KOL Reflection Dr. Raymond Benza MD, FACC, FAHA, FACP George M. and Linda H.

Kaufman Academic Chair of Cardiology, Sentara Health Phase 2b PAH study Steering Committee KOL: key opinion leader | MD: Doctor of Medicine | FACC: Fellow of the American College of Cardiology | FAHA: Fellow of the American Heart Association

| FACP: Fellow of the American College of Physicians | PAH: pulmonary arterial hypertension

These Results, Combined with Once-Daily Inhaled Profile, Reinforce TPIP’s

Potential to Become the Prostanoid of Choice Sustained improvements for patients remaining on TPIP and comparable benefits for patients who switched from placebo TPIP treatment led to meaningful reductions from baseline in REVEAL Lite 2.0

scores, a validated mortality risk assessment tool TPIP continued to demonstrate a favorable safety & tolerability profile with a low rate of cough (15%*, of which 85% was classified as mild) OLE: open-label extension | TPIP: treprostinil

palmitil inhalation powder | PAH: pulmonary arterial hypertension | The REVEAL Lite 2.0 (or REVEAL Lite 2) risk calculator is a simplified, non-invasive medical tool used to estimate the mortality and disease progression risk for adult patients

with PAH | TEAE: treatment-emergent adverse events | * Includes cough TEAEs that emerged after the first dose of the study drug was administered in the OLE (does not include TEAEs that emerged during the lead-in studies)

Next Steps: Design and Conduct an Expansive Registrational Program Across Four

inhalation powder | Note: Initiation indicates that trial sites are open and ready to screen patients for enrollment PH-ILD IPF PPF PAH TPIP Phase 3 patient enrollment progressing Phase 3 first trial sites actively screening Phase 3

initiation expected 2H:26 Phase 3 initiation expected 1H:27

Q&A Session Will Lewis Chair & CEO Sara Bonstein Chief Financial

Officer Martina Flammer Chief Medical Officer Gene Sullivan Chief Product Strategy Officer Thank you to the patients and investigators participating in this study! Dr. Raymond Benza George M. and Linda H. Kaufman Academic Chair of

Cardiology, Sentara Health

Appendix

Footnotes (1 of 3) Insmed Phase 2b Study of TPIP in PAH; Placebo-Adjusted

Reduction from Baseline PVR at Week 16; Analysis performed using an ANCOVA model, adjusting for treatment group, baseline pulmonary vascular resistance (PVR), and randomization stratification factors. The model was applied to log-transformed

PVR values, which were then back-transformed to the original scale; statistically significant, p<0.001; Measurements were taken at ~24-hours post dose (“at trough”); Topline results presented June 2025. Insmed Phase 2b Study of TPIP in PAH;

Placebo-Adjusted Improvement from Baseline 6MWD at Week 16; Covariate-adjusted estimate of location shift. Analysis performed using a rank ANCOVA model, adjusting for treatment group, baseline 6-minute walk distance (6MWD), and randomization

stratification factors; Nominally statistically significant, not adjusted for multiplicity, p=0.003; Measurements were taken at ~24-hours post dose (“at trough”); Topline results presented June 2025. Insmed OLE Study of TPIP in PAH (12 Month

Analysis); Patients in the TPIP Continued group showed a mean improvement from baseline 6MWD of 55.7 meters at Month 12. Patients in the Placebo Crossed group showed a mean improvement from baseline 6MWD of 54.1 meters; Measurements were taken

at ~24-hours post dose (“at trough”); The baseline values used in this OLE are from the Phase 2b study (pre-randomization values). The Phase 2a 24-hour PVR study single patient data were not included in this change from baseline analysis as no

baseline data were available; Last observation carried forward (LOCF) is used to impute the missing values at each visit; Interim OLE results presented July 2026. Insmed Phase 2b Study of TPIP in PAH; Placebo-Adjusted Mean Ratio to baseline

NT-proBNP of 0.40; Analysis performed using a repeated measures mixed model, adjusting for treatment group, baseline NT-proBNP, randomization stratification factors, visit and treatment-by-visit interaction. The model was applied to

log-transformed NT-proBNP values, which were then back-transformed to the original scale; nominally statistically significant, not adjusted for multiplicity, p<0.001; Measurements were taken at ~24-hours post dose (“at trough”); Topline

results presented June 2025. Insmed OLE Study of TPIP in PAH (12 Month Analysis); Patients in the TPIP Continued group showed a mean improvement from baseline NT-proBNP concentration of 60% at Month 12. Patients in the Placebo Crossed group

showed a mean reduction from baseline NT-proBNP concentration of 60%; Measurements were taken at ~24-hours post dose (“at trough”); The baseline values used in this OLE are from the Phase 2b study (pre-randomization values). The Phase 2a

24-hour PVR study single patient data were not included in this change from baseline analysis as no baseline data were available; Last observation carried forward (LOCF) is used to impute the missing values at each visit; Interim OLE results

presented July 2026. Insmed Phase 2b Study of TPIP in PAH; 30.4% of patients on TPIP improved WHO Functional Class by at least 1 category (vs. baseline) at Week 16 compared to 15% of patients on placebo; Topline results presented June

2025. Insmed OLE Study of TPIP in PAH (12 Month Analysis); ~80% of patients in the TPIP Continued group and the Placebo Crossed group achieved WHO Functional Class I or II at Month 12; Interim OLE results presented July 2026.

Phase 3 TRIUMPH study; Hodges-Lehmann (H-L) median treatment difference in change

from baseline 6MWD at 12 weeks measured at peak drug exposure (p<0.001); McLaughlin, V, Benza, R, Rubin, L. et al. Addition of Inhaled Treprostinil to Oral Therapy for Pulmonary Arterial Hypertension: A Randomized Controlled Clinical Trial.

JACC. 2010 May | URL: https://doi.org/10.1016/j.jacc.2010.01.027 TRIUMPH OLE Study; Median changes in 6MWD at 6, 12, 18, and 24 months were 28, 31, 32, and 18 meters, respectively, for all participants, inclusive of the significant attrition

in median change in walk distance for those patients who initially received the placebo; Benza RL, Seeger W, McLaughlin VV, et al. Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil

Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. J Heart Lung Transplant. 2011 | URL: https://www.tyvasohcp.com/pah/efficacy-safety/triumph-extension-study/ Phase 3 TRIUMPH

study; Hodges-Lehmann (H-L) between-treatment median difference in change from baseline NT-proBNP concentration measured at 12 weeks (p=0.0014) (ancillary endpoint); McLaughlin, V, Benza, R, Rubin, L. et al. Addition of Inhaled Treprostinil to

Oral Therapy for Pulmonary Arterial Hypertension: A Randomized Controlled Clinical Trial. JACC. 2010 May | URL: https://doi.org/10.1016/j.jacc.2010.01.027 Phase 3 TRIUMPH study; NYHA functional class was a prespecified secondary endpoint but

did not differ significantly between treatment and placebo at 12 weeks; McLaughlin, V, Benza, R, Rubin, L. et al. Addition of Inhaled Treprostinil to Oral Therapy for Pulmonary Arterial Hypertension: A Randomized Controlled Clinical Trial.

JACC. 2010 May | URL: https://doi.org/10.1016/j.jacc.2010.01.027 Footnotes (2 of 3)

SOTERIA OLE participants included eligible adults with PAH on stable background

therapy who completed a prior sotatercept study (Phase 2 or Phase 3) without early discontinuation were enrolled. Participants received subcutaneous sotatercept (≤0.7 mg dose once every 21 days). This differs from the design of the OLE studies

conducted for TYVASO and TPIP where OLE participants originated from the same lead-in (parent) study | Note on TPIP OLE: A single participant was enrolled in the OLE study from the Phase 2a 24-hour PVR study along with 90 participants from the

Phase 2b study Phase 2 PULSAR study; The greater degree of reduction in pulmonary vascular resistance as compared with placebo was seen at both dose levels of sotatercept, with the higher dose (0.7 mg dose) resulting in a 34% reduction from

baseline. Least-squares mean difference as compared with placebo -239.5 dyn.sec.cm-5 (baseline 755.9 dyn.sec.cm-5 for high dose); Humbert, M., McLaughlin, V., Gibbs, J. S. R., Gomberg-Maitland, M., Hoeper, M. M., Preston, I. R., Souza, R.,

Waxman, A., Escribano Subias, P., Feldman, J., Meyer, G., Montani, D., Olsson, K. M., Manimaran, S., Barnes, J., Linde, P. G., de Oliveira Pena, J., & Badesch, D. B. (2021). Sotatercept for the treatment of pulmonary arterial hypertension.

New England Journal of Medicine | URL: https://doi.org/10.1056/NEJMoa2024277 Phase 3 STELLAR study; Table 2. Change from Baseline at Week 24 in Primary and Secondary Efficacy End Points (Intention-to-Treat Population); The Hodges–Lehmann (H-L)

estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in the 6-minute walk distance was 40.8 m (p<0.001); Hoeper, M. M., Badesch, D. B., Ghofrani, H. A., et al. (2023). Phase 3 trial of

sotatercept for treatment of pulmonary arterial hypertension. New England Journal of Medicine 2023 | URL: https://doi.org/10.1056/NEJMoa2213558 SOTERIA OLE study; Supplementary Table 5. Change from Baseline at Week 24 and Year 1; Mean change

from baseline defined as measurement at Visit 1 of SOTERIA or the last measure from the parent study before rollover in 6MWD; Interim results of SOTERIA; Preston, I. R., Badesch, D. B., Ghofrani, H.-A., Hoeper, M. M., Channick, R. N., Chin, K.

M., Humbert, M., Jing, Z.-C., Lang, I. M., McLaughlin, V. V., Simonneau, G., Souza, R., Tapson, V. F., Torres, F., White, R. J., Beaufils, B., Kim, J. B., & Rubin, L. J. (2025). A long-term follow-up study of sotatercept for treatment of

pulmonary arterial hypertension: Interim results of SOTERIA. European Respiratory Journal, 2025 July | URL: https://doi.org/10.1183/13993003.01435-2024 Phase 3 STELLAR study; Table 2. Change from Baseline at Week 24 in Primary and Secondary

Efficacy End Points (Intention-to-Treat Population); The Hodges–Lehmann (H-L) estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in NT-proBNP concentration was -441.6 pg/mL; Hoeper, M.

M., Badesch, D. B., Ghofrani, H. A., et al. (2023). Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. New England Journal of Medicine 2023 | URL: https://doi.org/10.1056/NEJMoa2213558 SOTERIA OLE study;

Supplementary Table 5. Change from Baseline at Week 24 and Year 1; Mean change from baseline defined as measurement at Visit 1 of SOTERIA or the last measure from the parent study before rollover in NT-proBNP; Interim results of SOTERIA;

Preston, I. R., Badesch, D. B., Ghofrani, H.A., Hoeper, M. M., Channick, R. N., Chin, K. M., Humbert, M., Jing, Z.C., Lang, I. M., McLaughlin, V. V., Simonneau, G., Souza, R., Tapson, V. F., Torres, F., White, R. J., Beaufils, B., Kim, J. B.,

& Rubin, L. J. (2025). A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: Interim results of SOTERIA. European Respiratory Journal, 2025 July | URL:

https://doi.org/10.1183/13993003.01435-2024 Phase 3 STELLAR study; Table 2. Change from Baseline at Week 24 in Primary and Secondary Efficacy End Points (Intention-to-Treat Population); Percentage of patients with improvement from baseline WHO

functional class 29.4% for sotatercept arm and 13.8% for placebo arm; Hoeper, M. M., Badesch, D. B., Ghofrani, H. A., et al. (2023). Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. New England Journal of Medicine

2023 | URL: https://doi.org/10.1056/NEJMoa2213558 SOTERIA OLE study; Supplementary Table 5. Percent of patients in the Continued Sotatercept and Placebo-Crossed groups that achieved WHO-FC II/I by Year 1; Interim results of SOTERIA; Preston,

I. R., Badesch, D. B., Ghofrani, H.-A., Hoeper, M. M., Channick, R. N., Chin, K. M., Humbert, M., Jing, Z.-C., Lang, I. M., McLaughlin, V. V., Simonneau, G., Souza, R., Tapson, V. F., Torres, F., White, R. J., Beaufils, B., Kim, J. B., &

Rubin, L. J. (2025). A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: Interim results of SOTERIA. European Respiratory Journal, 2025 July | URL: https://doi.org/10.1183/13993003.01435-2024 Footnotes

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Jul. 16, 2026

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Bridgewater

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