AbCellera Biologics Inc. Common Shares 12th Annual Cantor Fitzgerald Global Healthcare Conference

Thanks, Steve, and thanks for having us. We are super excited about the data. Maybe just to set the table. In about 2023, AbCellera transitioned from a platform company to building our own assets. The lead program, ABCL635, is a first-in-class antibody against NK3R. It is being developed for the treatment of vasomotor symptoms or hot flashes that are associated either with menopause or with induced menopause or a menopause-like state that comes alongside of endocrine therapy in breast cancer and in prostate cancer. That program went into the clinic only at the start of the year and quickly moved through phase I. I guess it is now 3 weeks ago, we released the top-line 4-week data. Frankly, that data, I would say, blew the doors off even what we thought was the most bullish case for the product.

I think the punchline is that we have an antibody that is following a couple small molecules that are now approved and on the market. One is Lynkuet by Bayer, the other one is Astellas. The phase II data that we have shows efficacy of roughly twice those two products in reduction of the frequency of moderate to severe hot flashes and anywhere between, let us say, 4 or 5 times the efficacy in the reduction in a severity score, which is a 3-point score. In addition to that, the data showed an excellent safety profile. The two small molecules do have some issues with elevated liver enzymes, which we posited was because of metabolism of small molecules. An antibody, we believe, should not have that, and the data supports that. We have no evidence of elevated liver enzymes.

In addition to that, we saw remarkable efficacy in terms of patient-reported outcomes, like 80% of patients said they either felt much better or better. Surprisingly to us, a very obvious signal in sleep, so improved sleep, which is one of the really frustrating parts of menopause and hot flashes associated with menopause for many women. Across the board, in efficacy, in safety and convenience, we think we have a product that if we can translate this through to phase III, and there is no reason to think that we cannot, that it could be the dominant product for non-hormonal treatment of menopause symptoms. That is 3 weeks ago. Since then, a lot of thinking about how that real upside in efficacy has changed the commercial opportunity. We think it has very significantly changed the commercial possibility for the drug.

Then thinking about what are the plans to move as quickly and as safely and smoothly as possible into regulatory studies. That really means finishing this study. So we've got 12-week data and an open-label extension for 12 weeks. By the end of the year, we should have that. We'll start engaging with the regulatory agencies, with the FDA, Health Canada, EMA, maybe Australia as well, and then try to set up to start a phase III trial in the back half of next year. So from a preclinical company, less than a year and a half ago, to being on the precipice of having a phase III asset in what we think is a very de-risked asset and a multi-blockbuster opportunity, we are pretty excited.

I think you basically answered the question.

Okay. But just to sort of fill it out a bit.

The two small molecules, one is VEOZAH. That is a straight NK3R antagonist. The second product, Lynkuet, it began development as an NK1R antagonist, and it also has activity on NK3R. NK3R is the target that is known to be important in the infundibular nucleus on KNDy neurons for driving hot flashes. NK1R antagonism is associated with somnolence. We believed that the improved sleep quality that was seen in Lynkuet but not in VEOZAH was attributable to an off-target effect.

Yeah. Coming into this, because our antibody is clean and doesn't have a somnolent side effect, we didn't think we'd see the same effect on sleep.