AbCellera Biologics, Inc. Q1 FY2025 earnings call

Key Points

• Carl Hansen discussed ABCL635, a potential first-in-class therapeutic antibody for moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause, targeting NK3R. It has a well-understood science basis, large commercial opportunity, differentiation in safety and dosing, and a well-established development path.
• ABCL575 is on track with a CTA filing in Q2 and Phase 1 trials anticipated in Q3, with preclinical data on ABCL575 to be presented at SID.
• The company has a portfolio of over 20 internal and co-development programs, with progress on T-cell-engager platform and clinical manufacturing investments nearing completion.

In Q1, AbCellera had revenue of about $4 million. Research and development expenses were approximately $43 million, a net loss of roughly $46 million, and earnings per share was a loss of $0.15 per share. The company had approximately $630 million in cash and equivalents and ~$180 million in available committed government funding. They had a cumulative total of 97 programs with downstream participation and 16 molecules that had reached the clinic.

Forward-Looking Statements

• Plan to initiate Phase 1 clinical trials for ABCL635 and ABCL575.
• Complete CTA process this quarter, start Phase 1 study for ABCL635 in Q3 2025, and report key readouts of safety and early efficacy in mid-2026.
• Expect to start using clinical manufacturing capabilities later in 2025.

Risks

• Target engagement risk for ABCL635, as translating preclinical data to human studies is uncertain.
• Uncertainty related to NovaRock's paused trials of four Trianni-license molecules.
• General drug development risks, including the time and cost required to advance programs.

Q: What does ABCL635 need to see in Phase 1 data to capture competitive edge beyond dosing?

A: Need to see safety, biomarkers (early sign of target engagement), and efficacy data in participants. Biomarkers like testosterone levels are early readouts of target engagement. Differentiation includes cleaner safety profile and preferred dosing (once monthly subcutaneous injection).

Q: What to expect from ABCL575 preclinical data presented at SID?

A: Early animal work, PK analysis, and predictions for human studies. Differentiation aims for superior dosing regimen with at least 3 months, if not 6 months, dosing.

Q: How are next development candidates being considered?

A: Looking for high conviction biology, large unmet medical need, compelling differentiation, and efficient development path. Next candidate likely to be a GPCR or ion channel from difficult target classes, with disclosure depending on program status.

Q: Comments on NovaRock's paused trials and manufacturing in Canada?

A: NovaRock's trials paused likely related to fundraising; manufacturing facility in Canada supports Phase 1/2 trials, and no immediate consideration for U.S. manufacturing redundancies for early trials.

Q: Learnings from other trials relevant to ABCL635 and potential expansion beyond VMS?

A: Clear development path from prior NK3R molecule trials provides advantage. No current awareness of NK3R development in neurological indications; focus on first trial to get safety, biomarkers, and efficacy data.