verekitug (UPB-101) / Upstream Bio - LARVOL DELTA

Late Breaking Abstract - VALIANT: a phase 2 trial of the efficacy and safety of verekitug, a thymic stromal lymphopoietin (TSLP) receptor antagonist, for severe asthma (ERS 2026) - P2 | "In pts with severe asthma on standard background therapy, verekitug q12w or q24w led to statistically significant, clinically meaningful AAER reductions, early lung function and asthma symptom improvements, and a similar safety profile to PBO. Funding: Upstream Bio, Inc. NCT06196879."

Clinical • Late-breaking abstract • P2 data • Stroma • Asthma • Immunology • Respiratory Diseases • TSLP

Upstream Bio Presents Results from the Phase 2 VALIANT Trial of Verekitug for the Treatment of Severe Asthma in Oral Presentation at ERS Congress 2026 (GlobeNewswire) - "Verekitug, 100 mg dosed every 12 weeks, reduced AAER by 56% compared to placebo in patients with severe asthma...Verekitug improved the key secondary outcomes of FEV1 (forced expiratory volume in one second), FeNO (fractional exhaled nitric oxide), and asthma symptom control as measured by Asthma Control Questionnaire (ACQ-6) versus placebo at week 24, with improvements seen as early as week 2 across all key secondary outcomes...Verekitug was generally well tolerated across all active doses, demonstrating a favorable safety profile consistent with previous studies. Immunogenicity had no meaningful impact on safety or efficacy results."

P2 data • Asthma • Immunology

Upstream Bio Announces Pivotal Phase 3 Development Plans for Verekitug in Both Severe Asthma and CRSwNP (The Manila Times) - "The Company plans to execute Phase 3 programs evaluating: A single high-dose subcutaneous regimen of 400 mg administered every 12 weeks; A single placebo-controlled study in each indication enrolling a total of approximately 1,500 patients across both trials; Broad study populations without restriction based on baseline biomarkers; Study primary endpoints: Asthma - Annualized asthma exacerbation rates (AAER) over 48 weeks; CRSwNP - Co-primary endpoints of change from baseline in nasal polyp score (NPS) and in nasal congestion score (NCS) each at 48 weeks...Upstream Bio remains on track to initiate Phase 3 clinical trials in severe asthma and CRSwNP in the first quarter of 2027. With supportive Phase 3 results, the Company expects to submit a Biologics License Application (BLA) to the FDA for both indications, which could enable potential launch as early as 2030."

Launch US • New P3 trial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Lessons learned from clinical trials of thymic stromal lymphopoietin (TSLP) inhibition. (PubMed, J Allergy Clin Immunol) - "Tezepelumab is currently the only approved anti-TSLP therapy. Other TSLP-targeting agents, including ecleralimab, SHR-1905, bosakitug, verekitug, sunakiment, TAVO101, ocankitug, HBM9378, MG-ZG122, GB-0895, and solrikitug, are in clinical development."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • IL13 • IL5 • TSLP

Phase 2 VALOUR Long-Term Extension Study in Severe Asthma (GlobeNewswire) - "Data from the study are expected in the second half of 2027."

P2 data • Asthma • Immunology

Phase 2 VENTURE Trial in COPD Enrollment Completed (GlobeNewswire) - "The Company has completed enrollment in the VENTURE trial in COPD with 481 participants. Data are expected in the second half of 2027, and the Company believes that these analyses will provide important insights into the potential clinical impact of verekitug in COPD."

Enrollment closed • P2 data • Chronic Obstructive Pulmonary Disease • Immunology

Upcoming Initiation of Phase 3 Trials in Severe Asthma and CRSwNP (GlobeNewswire) - "The Company remains on track to initiate Phase 3 clinical trials in severe asthma and CRSwNP in the first quarter of 2027. End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) for both severe asthma and CRSwNP are on track. These interactions will support the Phase 3 development plans in both indications."

FDA event • New P3 trial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD (clinicaltrials.gov) - P2 | N=666 | Active, not recruiting | Sponsor: Upstream Bio Inc. | Trial completion date: Jul 2028 ➔ Nov 2027 | Trial primary completion date: Apr 2028 ➔ Oct 2027

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Verekitug: "Verekitug led to statistically significant improvements in AAER at 60 weeks with both q12w and q24w regimens"; Asthma (Upstream Bio) - Phase 2 VALIANT Top-line Results in Severe Asthma

P2 data • Asthma • Immunology

Upstream Bio Presents New Responder Analyses Demonstrating Clinically Meaningful Improvements in CRSwNP in Significant Majority of Participants Treated with Verekitug in the Phase 2 VIBRANT Trial at EAACI 2026 (Upstream Bio Press Release) - "Nasal Polyp Score (Primary endpoint): 79% of verekitug-treated participants, or approximately four in five treated, achieved clinically meaningful improvements in NPS at week 24, compared to 24% in the placebo group (odds ratio [95% CI], 12.06 [4.09–35.53] p<0.0001)...Total Symptom Score: 83% of verekitug-treated participants demonstrated at least four points of improvement in total symptom score, a key secondary endpoint, compared to 37% in the placebo group (odds ratio [95% CI]: 8.57 [2.86–25.67]; p<0.0001)...Upstream Bio designed the VIBRANT trial using endpoints that, pending interactions with regulatory authorities, could produce data to support submissions for product approval. The Company plans to initiate dosing in Phase 3 registrational trials in both CRSwNP and severe asthma in the first quarter of 2027."

New P3 trial • P2 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD (clinicaltrials.gov) - P2 | N=666 | Active, not recruiting | Sponsor: Upstream Bio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Upstream Bio…announced that additional data from its Phase 2 VIBRANT trial of verekitug in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) will be presented in an oral session at the European Academy of Allergy and Clinical Immunology (EAACI) 2026 Congress (GlobeNewswire) - "The presentation will feature a responder analysis examining the proportion of patients who achieved clinically meaningful improvements in key measures of disease with verekitug."

P2 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Verekitug, a novel TSLP receptor antagonist antibody, in participants with chronic rhinosinusitis with nasal polyps in VIBRANT: responder analysis using clinically meaningful efficacy outcome thresholds (EAACI 2026) - P2 | "Responder rates were significantly higher with verekitug versus placebo for NPS (79.5% vs 24.3%; odds ratio [OR], 12.06 [95% confidence interval, 4.09–35.53]; P <0.0001), NCS (72.2% vs 39.5%; OR, 3.99; P =0.0046); DSS (69.4% vs 21.1%; OR, 8.52; P <0.0001); NBS (80.6% vs 39.5%; OR, 6.35; P =0.0003); TSS (83.3% vs 36.8%; OR, 8.57; P <0.0001); and LMK (75.7% vs 12.1%; OR, 22.56; P <0.0001; Table ). Conclusion Conclusions Significantly greater proportions of participants with CRSwNP treated with verekitug compared with placebo demonstrated clinically meaningful improvements in objective and patient-reported outcomes."

Clinical • Immunology • CRLF2 • TSLP

Upstream Bio Presents New Data from Phase 2 VIBRANT Trial of Verekitug Demonstrating Improvement in Asthma Symptom Control in Participants with CRSwNP and Comorbid Asthma at the ATS 2026 International Conference (GlobeNewswire) - "Among participants with comorbid asthma, verekitug 100 mg administered every 12 weeks led to improvement in asthma symptom control at Week 24, with a placebo-adjusted least squares mean (LSM) reduction in ACQ-6 of -0.9 (95% CI: -1.6 to -0.2; nominal p=0.014) compared with placebo—well above the minimal clinically important change in ACQ-6 of -0.5. Verekitug also led to improvements in NPS at Week 24 in participants with and without comorbid asthma....In a separate post hoc analysis, verekitug 100 mg administered every 12 weeks led to rapid and sustained reductions in key type 2 inflammatory cytokines, including IL-4, IL-5, and IL-13, in both blood and nasal secretions over 24 weeks of treatment with generally greater reductions observed in nasal secretions."

P2 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Phase 2 VENTURE Trial in COPD (GlobeNewswire) - "The Company has enrolled more than 400 participants in the Phase 2 VENTURE trial in COPD (NCT06981078)....The Company plans to cap further enrollment in the VENTURE trial; currently enrolled participants will remain in the study to its completion. Data are now expected in the second half of 2027, and the Company expects that these analyses will provide important insights into the potential impact of verekitug in COPD as it plans a Phase 3 trial of verekitug in COPD."

Enrollment status • P2 data • Chronic Obstructive Pulmonary Disease • Immunology

Phase 3 Strategy for High-Dose Quarterly Administration in Broad Patient Populations in Severe Asthma and CRSwNP (GlobeNewswire) - "The Company plans to meet with regulators in mid-2026 to gain alignment on Phase 3 plans for verekitug in severe asthma and CRSwNP and expects to initiate both registrational studies in the first quarter of 2027."

New P3 trial • Regulatory • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Phase 2 VALOUR Long-Term Extension Study in Severe Asthma (GlobeNewswire) - "The study completed enrollment in March 2026 with more than 90% retention of eligible patients from the Phase 2 VALIANT study."

Enrollment closed • Asthma • Immunology

Additional Analyses of Phase 2 VIBRANT Data to be Presented at American Thoracic Society (ATS) 2026 International Conference and the European Academy of Allergy and Clinical Immunology Congress 2026 (EAACI) (GlobeNewswire) - "The presentations at ATS and EAACI will feature new data from the Phase 2 VIBRANT trial, including data evaluating verekitug in participants with CRSwNP and comorbid asthma, as well as data on the effect of verekitug on Type 2 inflammatory biomarkers in CRSwNP at ATS."

P2 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Upstream Bio to Present New Data from Phase 2 VIBRANT Trial of Verekitug at the ATS 2026 International Conference (GlobeNewswire) - "The presentations feature new data from the Phase 2 VIBRANT trial evaluating verekitug, the only known antagonist to the thymic stromal lymphopoietin (TSLP) receptor currently in clinical development, in chronic rhinosinusitis with nasal polyps (CRSwNP). The data to be presented include the clinical effect of verekitug in participants with CRSwNP and comorbid asthma, as well as its impact on nasal and blood biomarkers."

P2 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR) (clinicaltrials.gov) - P2 | N=396 | Active, not recruiting | Sponsor: Upstream Bio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT) (clinicaltrials.gov) - P2 | N=479 | Completed | Sponsor: Upstream Bio Inc. | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Recent Business Highlights (GlobeNewswire) - "The Company plans to meet with regulators later this year to gain alignment on Phase 3 plans for verekitug in severe asthma and CRSwNP and expects to initiate both registrational studies in the first quarter of 2027...Enrollment is ongoing in the Phase 2 VENTURE clinical trial in COPD (NCT06981078), which was initiated in July 2025...The VENTURE study is more than 60% enrolled."

Enrollment status • FDA event • New P3 trial • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Efficacy and Safety of Verekitug (UPB-101) in Chronic Rhinosinusitis With Nasal Polyps: Results of the Phase 2 VIBRANT Trial (AAAAI 2026) - P2 | "Treatment-related adverse events occurred more frequently with placebo (7.5% vs 2.5%). Conclusions Verekitug, dosed every 12 weeks, significantly reduced nasal polyp size, nasal symptoms, and the need for ESS or SCS, and was well-tolerated in adults with uncontrolled, severe CRSwNP."

Clinical • Late-breaking abstract • P2 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • CRLF2 • TSLP

Verekitug, a Thymic Stromal Lymphopoietin Receptor Antagonist, Administered in Participants With Chronic Rhinosinusitis With Nasal Polyps and Comorbid Asthma in the Vibrant Trial (ATS 2026) - No abstract available

Stroma • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • TSLP

Verekitug, a Thymic Stromal Lymphopoietin Receptor Antagonist, in Chronic Rhinosinusitis With Nasal Polyps: Effect on Type 2 Inflammatory Biomarkers in the VIBRANT Trial (ATS 2026) - No abstract available

Biomarker • Stroma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • TSLP