AbCellera Biologics Inc. Q2 FY2025 earnings call

Key Milestones

• Received Health Canada authorization to initiate first 2 clinical trials for ABCL635 and ABCL575; dosing begun in ABCL635 Phase I for moderate to severe vasomotor symptoms; ABCL575 Phase I trial opened, dosing soon to begin.
• Advanced ABCL688 into IND-enabling studies, adding a third program to the pipeline.
• Ended the quarter with approximately $750 million in available liquidity.

Programs

• ABCL635: First-in-class therapeutic antibody for moderate to severe vasomotor symptoms; Phase I trial is randomized, placebo-controlled, double-blind; primary endpoint is safety, secondary is pharmacokinetics; initial safety and efficacy data expected mid-2026.
• ABCL575: Antibody therapy targeting OX40 ligand for atopic dermatitis; preclinical data shows potent functional activity; engineered with half-life extension for less frequent dosing.
• ABCL688: Potential antibody medicine for autoimmunity, advanced into IND-enabling studies; details withheld for strategic reasons.

Priorities

• Execute clinical studies for ABCL635 and ABCL575.
• Move ABCL688 forward in IND-enabling studies.
• Advance a fourth program from discovery into the pipeline.
• Bring clinical manufacturing capabilities online.

In the second quarter, revenue was approximately $17 million, consisting of $10 million from licensing (stemming from the Trianni humanized rodent platform) and $7 million from research fees. Research and development expenses were approximately $39 million, net loss was roughly $35 million. Cash and equivalents stood at approximately $580 million, with total available liquidity around $750 million. Revenue in Q2 2024 was $7 million. Licensing fees of $10 million were a one-off related to the Trianni acquisition.

Forward-Looking

• Completed transition from platform company to clinical stage biotech. On track to complete 2025 goals: continue building pipeline by advancing at least one more development candidate into IND-enabling studies, complete platform and infrastructure investments, and start using clinical manufacturing capabilities.
• ABCL635 Phase I data expected mid-2026; ABCL575 dosing soon to begin; intent to submit IND for ABCL688 in mid-2026.

• Scientific Risk: For ABCL635, the main scientific risk is achieving sufficient target engagement. - Safety Concerns: NK3R class has seen liver toxicity and somnolence, but ABCL635 antibody is not expected to have these issues as it doesn't target NK1R and antibodies aren't metabolized in the liver, but efficacy and safety need to be demonstrated in trials.

Q: Congrats on the progress. Any risk to the development path for ABCL635 from the delayed PDUFA for elinzanetant?

A: FDA requested additional information from Bayer, but expectation is approval later this year; focus will be on efficacy and safety in evaluating ABCL635.

Q: Details on the ABCL635 Phase I trial?

A: The trial is randomized, placebo-controlled, double-blind; includes single ascending dose (SAD) with healthy men and women, and multiple ascending dose (MAD) with postmenopausal women; total patients around 56-60, with data on biomarkers (LH, FSH, etc.) in SAD and efficacy from proof-of-concept study mid-2026.

Q: Partnership and licensing revenue for the quarter?

A: $10 million licensing revenue was a one-off related to activities post the acquisition of Trianni, not expected to be recurring.

Q: Key efficacy data to look for in the ABCL635 Phase I study?

A: Biomarkers (LH, FSH in men and women, testosterone in men, estradiol in women) in SAD; efficacy data from proof-of-concept study with 80 postmenopausal women with moderate to severe VMS mid-2026.

Q: 575 trial in Canada, plans for U.S. sites?

A: Focus on Canada Phase I site; plan to engage FDA for Phase II studies, which may include U.S. sites later, but currently focused on Canada Phase I.

Q: Details on ABCL688?

A: Bullish on the program, moving quickly to clinic; details withheld for strategic reasons, but it's a program with high conviction in biology.