AbCellera (ABCL) Q2 FY26 earnings call: guidance and Q&A

What constitutes success for ABCL635's upcoming VMS data, specifically regarding severity and frequency reduction thresholds?

Carl Hansen stated that success means a clean safety profile and efficacy comparable to approved small molecules (e.g., 20% response rate and reduction of at least 2 hot flashes/day for frequency). Severity is expected to track with frequency and has historically been easier to hit.

“On the frequency side, we are obviously looking for a response relative to placebo that's on the order of 20% at least, which is about what you see with the small molecules. And there's an additional requirement that you have at least 2 -- a reduction in frequency of at least 2 hot flashes per day, which is something that we expect to meet under the same criteria.”

asked by Steven Seedhouse · answered by Carl L. Hansen

Why not move directly to Phase III label-enabling studies for cancer-related VMS, given prior data and dose selection from menopause studies?

Carl Hansen explained that moving into this patient population (oncology patients) is a first step before later-stage trials. The company plans to initiate these studies relatively soon, sequencing them as quickly as possible after the menopause study readout.

“My understanding is that moving it first into this patient population, which is obviously going to be significantly different given that you're dealing with patients that have oncology is the first step before moving into later-stage trials.”

asked by Steven Seedhouse · answered by Carl L. Hansen

How will AbCellera establish definitive safety differentiation in Phase III, particularly regarding liver monitoring, and could this help capture the first-line non-hormonal market?

Carl Hansen emphasized safety as a key differentiator, noting that small molecules have inconvenient liver monitoring requirements. He stated that ABCL635 has shown no perceptible increase in liver enzymes so far, consistent with an antibody's properties. He also highlighted the absence of somnolence, a side effect seen with a competitor, due to ABCL635's specific NK3R binding. He believes improved safety is paramount for this product.

“Both the 2 small molecules have liver monitoring. That is inconvenient, both in practice and for patients... The other thing that you didn't mention on the safety side is there has been a somnolence side effect associated with the Bayer molecule. That's a somnolence side effect that we believe is associated with binding of that molecule, not just to NK3R but NK1R. We have an antibody that is specific, entirely specific to NK3R.”

asked by Srikripa Devarakonda · answered by Carl L. Hansen

What percentage of internal resources are dedicated to the TCE platform compared to others like GPCR/ion channel?

Carl Hansen stated that much of the foundational work for the TCE platform is "in the bank," allowing for execution on new programs without a large change in resource allocation. He noted that significantly more effort is currently on the GPCR and ion channel side, but TCE remains a strong pillar.

“I don't have a hard number, but I'd say that there's significantly more effort on the GPCR and ion channel side, but TCE has been one of the strong pillars of the pipeline, and we expect it will stay that way for the coming future.”

asked by Srikripa Devarakonda · answered by Carl L. Hansen

What are the expectations for the placebo arm in the Phase II study, and how is the trial designed to mitigate placebo responses?

Carl Hansen confirmed that a pronounced placebo response is expected, comparable to what has been seen in other trials. Mitigation strategies include good clinical operations and a patient enrollment period without disclosing exact numbers.

“The trials that have been done have all shown a pronounced placebo response. And so our expectation coming into the study is that we will also have a placebo response and that it will be in the range that's comparable to what has been seen.”

asked by Allison Bratzel · answered by Carl L. Hansen

Will Phase II efficacy data be available for 4 weeks in all patients, or 12 weeks for some? How is the commercial opportunity for VMS being considered for Phase III design, specifically regarding non-hormonal alternatives vs. HRT comparisons?

Carl Hansen confirmed the upcoming data will be 4 weeks for all patients, noting historical correlation between 4-week and 12-week data. For the commercial opportunity, he highlighted a large unmet need for non-hormonal options (over 1 million women in the U.S. alone) and for VMS associated with cancer therapy (prostate and breast cancer), where hormones are not an option. He stated that Phase III design considerations are premature but will factor in these patient populations.

“So first, the data that we're expecting very soon is going to be data that is 4 weeks in all patients... we think at the very base case, there are a large number of women that are contraindicated and that would benefit from a non-hormonal option. As I've said on previous calls, we think that, that's roughly -- it's probably over 1 million women in the U.S. alone.”

asked by Brendan Smith · answered by Carl L. Hansen