AbCellera Biologics (ABCL) investor relations material

ABCL635 phase II results

• First-in-class antibody for non-hormonal treatment of menopause- and cancer-therapy-associated vasomotor symptoms (VMS).

• In a ~92-patient, 1:1 placebo-controlled study, ABCL635 reduced hot-flash frequency by 50% versus placebo, roughly twice the reduction reported for approved small molecules.

• Hot-flash severity improvement was 3.5x–5x that of small molecules, with a clean safety profile and PK/PD supporting once-monthly dosing.

• After one 600 mg dose, 37% of participants had complete VMS resolution at week 4; the result was described as at least comparable to hormone therapy.

• Sleep scores were at least equivalent to LYNKUET despite no NK1R activity; the proposed explanation was greater VMS reduction without NK1R-associated somnolence risk.

Development and regulatory plans

• The 600 mg single dose was selected to model steady-state exposure from 300 mg once-monthly dosing; an eight-week washout will map efficacy against drug exposure.

• After 12 weeks, active and placebo participants can receive another single 600 mg dose; a second week-4 efficacy readout is expected early next year, with roughly 3x as much efficacy data overall.

• FDA Model-Informed Drug Development participation is intended to use PK/PD modeling to inform phase III dosing; regulatory discussions are planned through the first part of next year.

• Late-stage menopausal VMS studies are planned for next year; prostate- and breast-cancer studies are also expected to start next year.

• Phase III planning benchmarks a safety database of ~1,500 patients and a ~2.5-year timeline from first patient in to readout, based on LYNKUET; recruitment is not expected to be a major constraint.

Market and commercial opportunity

• If phase III confirms the results, ABCL635 could offer better efficacy, safety and convenience; stronger efficacy may broaden use among patients who are eligible for but choose not to take hormone therapy.

• Approved small molecules have net pricing of ~$5,000 per year; higher pricing may be supportable, subject to access and pricing decisions across U.S. and international markets.

• Hormone-therapy supply constraints, greater patient demand and shifts toward primary-care and virtual menopause services were described as market tailwinds.

• Commercial models under review include telehealth, direct delivery and potentially direct pay; no commercialization commitment was made.

• Median hot-flash duration is ~7 years, with 10%–20% of patients experiencing symptoms beyond 10 years, supporting potential long-duration treatment demand.