AbCellera Biologics (ABCL) investor relations material

Lead program overview and clinical data

• ABCL635, a first-in-class NK3R antibody, showed phase II efficacy roughly double that of approved small molecules for vasomotor symptoms (VMS) and a strong safety profile with no elevated liver enzymes.

• 80% of patients reported feeling much better or better, with notable improvements in sleep quality and no somnolence risk.

• 37% of patients had complete resolution of hot flashes after a single dose, and 24% had zero severity, indicating potential for a curative effect in a significant subset.

• The 12-week data and open-label extension are expected by year-end, with phase III trials planned for the second half of next year.

• Modeling from phase II will inform phase III dose selection, with monthly dosing anticipated.

Regulatory and development strategy

• Engagements with FDA, Health Canada, EMA, and Australia are planned to support phase III initiation.

• The FDA Model-Informed Drug Development Program is being used to optimize phase III design.

• Phase III will likely enroll about 1,500 patients, with co-primary endpoints of frequency and severity reduction.

• Additional phase II trials are planned for breast and prostate cancer patients experiencing VMS.

• Broader patient populations and expanded safety databases are being considered, inspired by competitor studies.

Market landscape and commercial outlook

• VEOZAH and LYNKUET, the leading small molecules, are tracking toward multi-billion dollar sales despite initial slow uptake and payer challenges.

• The market for non-hormonal VMS treatments remains largely untapped, with robust growth and significant opportunity for new entrants.

• ABCL635 is positioned for differentiation on efficacy, safety, and convenience, potentially commanding a premium price.

• Commercialization strategy is undecided, with options including building an internal sales force or partnering with established players.

• A launch around 2030 is anticipated, allowing time for strategic planning and organizational growth.