H. Lundbeck (LUN) Study update summary

Study background and rationale

• Bocunebart (formerly Lu AG09222) is the first and only PACAP biologic to reach this stage in migraine prevention, offering a novel mechanism distinct from CGRP therapies, with other anti-PACAP candidates discontinued.

• The PROCEED phase II-B trial followed positive results from the earlier HOPE phase II-A study, both showing efficacy in migraine prevention and strengthening confidence in bocunebart as a first-in-class PACAP-targeting treatment.

• PACAP inhibition targets broader migraine biology, potentially benefiting patients not optimally managed by current CGRP therapies and raising attack thresholds.

• The global migraine prevention market is projected to exceed $12 billion by 2031, with significant unmet need, especially in chronic migraine.

• Bocunebart is positioned to address patients with severe, chronic migraine who have failed multiple prior treatments and may offer an alternative for those underserved by current therapies.

PROCEED trial design and results

• PROCEED was a phase II-B, dose-ranging, placebo-controlled trial in patients with hard-to-treat migraines who failed one to four prior treatments, with both subcutaneous and intravenous arms; the IV arm proceeded after futility in the subcutaneous arm.

• The primary endpoint was reduction in monthly migraine days over 12 weeks; the IV dose A group achieved statistically significant reduction versus placebo.

• Bocunebart demonstrated a greater effect in chronic migraine patients, with a mean reduction of 5.94 monthly migraine days compared to 3.63 with placebo at 12 weeks.

• Bocunebart demonstrated a clean safety profile, with the most common adverse event being nasopharyngitis, and no new safety signals identified; safety was further supported by Phase I data on co-administration with acute migraine therapies.

• Pooled data from HOPE and PROCEED in chronic migraine showed a 2.3-day greater reduction in monthly migraine days versus placebo (p<0.001), with meaningful improvements in quality of life.

Efficacy in chronic migraine and clinical relevance

• Reductions were also seen in monthly headache days and days requiring acute medication, with meaningful improvements in quality of life.

• The effect was consistent across key clinical endpoints and the safety profile remained favorable.

• The drug is being positioned for patients with the greatest unmet need—those with chronic, severe migraine who have failed multiple prior treatments.

• Regulatory discussions for phase III design are planned, with potential initiation in the second half of 2026.

• Bocunebart remains investigational and is not yet approved by regulatory authorities.