Slide 1: Barzolvolimab EMBARQ-CSU1/CSU2 Phase 3 Topline Results
Barzolvolimab EMBARQ-CSU1/CSU2 Phase 3 Topline Results SEPTEMBER 22, 2026 DATA CUTOFF: SEPTEMBER 9, 2026
Slide 2: Safe Harbor Statement
Safe Harbor Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-l
Slide 3: For decades, well-controlled disease has been accepted as adequate in CSU
For decades, “well-controlled disease” has been accepted as an adequate outcome in CSU. With barzolvolimab, the data clearly show we have an opportunity to do better for patients… 3
Slide 4: EMBARQ-CSU1/CSU2 Pivotal Phase 3 Trials Met Primary and All Key Secondary Endpoints
EMBARQ-CSU1/CSU2 Pivotal Phase 3 Trials Met Primary and All Key Secondary Endpoints Novel, First-In-Class Barzolvolimab: Potential Transformational Therapy for People With CSU Profound Efficacy results Efficacy impact on consistent in sustained or Best in disease* severe omalizumab deepened Favorabl
Slide 5: CSU: Patient Population with a High Unmet Need for More Effective Treatments
CSU: Patient Population with a High Unmet Need for More Effective Treatments Underdiagnosed disease of misery affecting 1.8MM people in the US alone, characterized by: • Relentless spontaneous hives • Significant mental health burden • Unbearable itch • Impacts all aspects of life2,3 • Sleep disrupt
Slide 6: Phase 3 CSU Registration Program: Largest Program in Antihistamine Refractory CSU
Phase 3 CSU Registration Program: the Largest Program Conducted in Antihistamine Refractory CSU, Including Patients With Advanced Therapy 52 Week Total Treatment Period 4 Week 24 Week Placebo Controlled Treatment Period 28 Week Active Treatment Period 16 Week Follow Up Period Screening -4 0 4 8 12 1
Slide 7: Well-Balanced Patient Population Across Studies
Well-Balanced Patient Population Across Studies Patients had Severe Disease at Baseline EMBARQ-CSU1 EMBARQ-CSU2 Placebo Q4W Barzolvolimab Barzolvolimab Placebo Q4W Barzolvolimab Barzolvolimab (N=325) 150 mg Q4W 300 mg Q8W (N=321) 150 mg Q4W 300 mg Q8W (N=320) (N=318) (N=324) (N=321) Age (years) 46.4
Slide 8: Efficacy Results
Efficacy Results
Slide 9: Primary Endpoint: Improvement in Mean Change from Baseline in UAS7 at Week 12
Primary Endpoint: Clinically Meaningful and Highly Statistically Significant Improvement in Mean Change from Baseline in UAS7 Score at Week 12 EMBARQ-CSU1 EMBARQ-CSU1 EMBARQ-CSU2 EMBARQ-CSU2 Barzolvolimab Barzolvolimab Barzolvolimab Barzolvolimab Placebo Placebo 150 mg Q4W 300 mg Q8W 150 mg Q4W 300
Slide 10: All Key Secondary Endpoints Met at Week 12
All Key Secondary Endpoints Met at Week 12: Clinically Meaningful and Highly Statistically Significant Consistent with Phase 2 Experience Trials met key secondary endpoints of high importance to patients and physicians • Proportion of patients with complete response (UAS7=0) • Proportion of patients
Slide 11: Complete Response (UAS7=0) Results Show Potential to Set New Treatment Standard
Complete Response (UAS7=0) Results Show Potential to Set New Treatment Standard Complete Absence of Disease Activity Sustained or Deepened Over 24 Weeks Week 12 Week 24 EMBARQ-CSU1 EMBARQ-CSU1 EMBARQ-CSU2 EMBARQ-CSU2 EMBARQ-CSU1 EMBARQ-CSU1 EMBARQ-CSU2 EMBARQ-CSU2 p <.00001 p < .00001 p <.00001 p <
Slide 12: Higher Complete Response Rates in Omalizumab-Refractory CSU at Week 12
Statistically and Clinically Significant Higher Complete Response Rates (UAS7=0) Achieved in Omalizumab-Refractory CSU at Week 12, a Population of High Unmet Need EMBARQ-CSU1 EMBARQ-CSU1 EMBARQ-CSU2 EMBARQ-CSU2 p = .00017 p = .0036 p <.00001 p = .0089 80 80 55.3 Participants Achieving UAS7=0 at Week
Slide 13: Majority Achieved Complete Angioedema Control (AAS7=0) at Week 12
Majority of Patients Who Have AAS7>0 at Baseline Achieved Complete Angioedema Control (AAS7=0) at Week 12 Potential to Set New Standard in Angioedema Control EMBARQ-CSU1 EMBARQ-CSU1 EMBARQ-CSU2 EMBARQ-CSU2 p < .00001 p < .00001 p < .00001 p <.00001 Participants Achieving AAS7=0 at Week 12 90 Partici
Slide 14: Safety Results
Safety Results
Slide 15: Favorable Safety Profile Consistent with Prior Experience
Favorable Safety Profile Consistent with Prior Experience Adverse Events Through 24 Week Placebo Controlled Period (AEs observed in > 3% of patients) Pooled EMBARQ-CSU1 and EMBARQ-CSU2 N (%) Placebo Q4W Barzolvolimab Barzolvolimab 150 mg Q4W 300 mg Q8W • On barzolvolimab, the (N=645) (N=648) (N=641)
Slide 16: Barzolvolimab Did Not Lead to Increased Rate of Infections
Barzolvolimab Did Not Lead to Increased Rate of Infections Neutropenia Not Associated with Increased Incidence of Infections No increased rates of infection Rates of neutropenia in in barzolvolimab vs placebo Phase 3 were consistent treatment groups with Phase 2 • Placebo: 23.9% • Placebo: 0.6% • 15
Slide 17: Bringing Barzolvolimab to Patients
Bringing Barzolvolimab to Patients
Slide 18: Phase 3 Data Support Potential to Address Two Large CSU Populations
Phase 3 Data Support Barzolvolimab Potential to Uniquely Address Two Large CSU Populations With Significant High Unmet Need Potential Future CSU Treatment Paradigm1 Potential therapy of Tx with CSU Antihistamine choice for 2L advanced Diagnosis Antihistamines dose escalation Symptomatic therapy Rx o
Slide 19: EMBARQ Phase 3 Results Support Potential for Patient Impact & Commercial Success
EMBARQ Phase 3 Results Support Barzolvolimab Potential to Deliver Transformational Patient Impact & Commercial Success Barzolvolimab is a novel, first and only-in-class antibody with an MOA that addresses the root cause of CSU Favorable consistent safety and tolerability profile across multiple stud
Slide 20: Results Support Barzolvolimab's Potential to be a Life-Changing Therapy in CSU
Results Support Barzolvolimab’s Potential to be a Life- Changing Therapy in CSU • Results offer new hope for patients, physicians and CSU community • Both Phase 3 trials met all primary and key secondary endpoints with high statistical significance at both dose levels • Favorable safety profile cons
Slide 21: Questions
Questions