All right, good morning, everyone. I'm Stephen Willey one of the senior biotech analysts here at Stifel , and glad to have with us here to kick things off this morning, from AbCellera Biologics CFO, Andrew Booth. Andrew, thanks.
Hi, Steve.
Thank you
For coming.
Thank you for having me. Good to be here.
Maybe before we jump into Q&A, if there's any, I guess, any opening statements, introductory comments you want to make about the company?
Yeah, I'll just, first of all, thank you for having me here. The regular disclaimers that I may be saying forward-looking statements, and please check the SEC filings for all of our necessary risks or reported risks.
Okay. So you're obviously, you've made the transition, right, from kind of becoming a portfolio platform-focused company to one that is now developing your own clinical assets. That's definitely kind of a transition I want to, I want to talk to you. Maybe we can just kind of talk a little bit about, you know, the partnership side of the business and kind of what drove that transition, from kind of being not necessarily kind of a service provider, right, but kind of being more in control of your own drugs, wanting to take ownership of that. Should we expect that ownership potential for the wholly owned assets that you move into the clinic should also possibly increase over time in terms of the amount of economics that you want to retain?
Yeah, happy to comment on that. Actually, the kind of lead-up to that is, you know, AbCellera has now been around for about 13 years. It was founded in 2012. You're right. At the beginning, the investments were all on the capability building and the platform. We were doing that, working on some of the hardest programs out there that were funded by our partners. We were able to, for the majority of the first decade of the company, use the partnership business and the partnership model as a way to invest and build up our own capabilities with the goal of really focusing on the highly differentiated, very difficult targets. We've talked about those in the past. Antibody discovery and development programs that have some kind of technical challenge that need to be overcome.
We believed we could invest in that capability to get to a different technology curve for finding therapeutic antibodies. We focused in on that by bringing this capability to our partners. As you say, not really in a service model, but in a way where we would get paid for what we would do, but importantly, we would retain some of the upside and the success of the molecules that we discovered, participating in downstream milestones and then ultimately royalties. Over time, as the company built, the focus for us was capturing that long-term value, increasing in the royalty position, moving into co-development where we would have like a 50/50% stake.
Even then, you know, back in 2021 or so, really making a shift, not solving for volume there, but really solving for working on difficult problems where we believed our technology could make a difference and with partners who we believed had the wherewithal to get them through to the clinic and then move them on ultimately to patients. During that time, there was a real focus on building those capabilities. Now, as you say, we have made a transition into using those capabilities still for our partners. We have some strategic partners. They're really the big pharma partners that we're focusing on, focused on with Lilly and AbbVie. That has been a conscious shift. You've watched it over the last number of years.
Recently, or about two or three years ago, we made the decision to say, no, and we're also going to move forward our own assets. It took some time to get those into the clinic. As you said, we would consider that transition complete this year in 2025 as the first two of those wholly owned assets moved into the clinic in the second quarter. In the third quarter, we also announced that the next one has moved into the IND- enabling studies. I think that has been received well by the market as well as by our employees and the focus and direction on that.
Mm-hmm.
Where when we said we were going to move, that was the strategic choice. We followed that up with the execution and hit the timelines of bringing these first two assets to the clinic. We're pretty excited about that. We'll have the first readouts in 2026.
Okay. Like you said, I think there's still some, you're still entertaining partnership opportunities, right? Maybe you can explain to us what that checklist needs to look like in order for you to.
Yeah.
Choose to work with a partner now.
Yeah. And, you know, we have worked on over 100 programs with partners. And we have, on an annual basis, we do give more color as to what that portfolio of downstream positions looks like in terms of how many are we still working on and how many do we know are not being pursued by partners. And we still occasionally will do that, but we actually put those programs to the same test that we put our own internal programs through. Like, do we like the science? Do we think there's a big commercial opportunity? Do we have an angle on differentiation? And is there a good clinical development path? Those are typically, that's typically the framework that we use.
In the case where it's a partnership, it's also got to be a molecule, a program where we don't really have an angle on our own how we could pursue that. The partner is typically bringing something to the table that we wouldn't be able to pursue that part, that program without the partner, whether it's their clinical development expertise or some other technology, which has been the way we have gotten into these co-development ones. If it's a smaller company, we've actually managed to negotiate a full co-ownership of a molecule that uses both our own capabilities as well as that of a partner.
Okay. Are partners or potential partners now maybe a little bit more cautious in the sense that, you know, you are developing your own pipeline of drugs, right? I think before that kind of wasn't the case. I guess as a partner now coming to AbCellera, how do you, I guess, you know, solve for those two things in doing a deal?
Yeah, we get this comment quite a lot. We have for years, actually, but we don't see it in the day-to-day. Generally, partners and well-enabled partners come to us because maybe they're stuck and they see that we might be able to, and there's a partner, there's a program that's important to them, and maybe we can get them unstuck or bring some technology to the, or capability to the program that they just wouldn't have access to. A good example of that is recently, in this year, we announced a T-cell engager deal with AbbVie.
Mm-hmm.
We've been talking about and working on the T-cell engagers because it's a particularly difficult antibody discovery program of how to engage T-cells and engage them and activate them in just the right way, but then partner them in a bispecific format, or even a multi-specific format. That is a program that AbbVie, we're pursuing with AbbVie, some of our own internal programs and with AbbVie, with the ones that are important to them. For us, that actually helps us build a relationship with those companies. They get to understand the scientific rigor and our, the level of quality we have in discovery and development. If anything, it builds that relationship in the event we might want to partner one of our assets maybe at a later stage.
It's almost a presale activity, you could say, in that licensing. If there are assets in our portfolio that we would want to license, it's great to have those relationships.
Yep. No, that's a good point.
I think that's a win-win, actually.
Yep. Yep.
I don't think, we don't see that as a deterrent or we don't get that response from those select partners that we choose as a deterrent. It's more of a feature.
Mm-hmm. And you talked about the, I guess, the scientific acumen that you've built up in the T-cell Engager space. I know you've also built up some acumen in the GPCR and Ion channel space. Are those primarily kind of like the two silos where partners now are coming to you, for antibody generation?
Yeah, I know, and I know it's part of the legacy of, like, we've been in the partnership business for some time, but really the focus is on the internal pipeline.
Mm-hmm.
Yes, the difficult targets are a particularly difficult antibody discovery program is what we believe we're known for and what our capabilities are, well suited for. We have historically done that and continue to do that for our partners should they ask. We have a great set of partners with Lilly, Regeneron, Novartis, and others. As you know, there's great validation on the capabilities from those partners that we've worked with. The focus has turned to really applying that capability to our own internal pipeline. You know, the case in point is ABCL635, which is a GPCR target.
Mm-hmm.
I know we're going to talk about that one in a, in a second.
Yeah. Let's talk about ABCL635. And maybe you can just kind of, at a high level, introduce the genesis of this thing. And, you know, these targets, I guess, have been historically very challenging. I guess from a discovery perspective, you know, how does, how did your platform differentiate in this instance and allow for the nomination of this asset?
Yeah. ABCL635 is an antibody against the NK3R, neurokinin 3 receptor. How we came about this asset is it went through that framework that I, that I quickly overviewed previously. It's like, do we like the science? In this case, you know, the NK3R pathway is actually well validated by small molecules. We can talk about that in terms of the competition, that they are building the class of non-hormonal treatments for hot flashes associated with VMS. The science we think is very well validated. The commercial opportunity is huge, and we can go into some of those numbers, but women experiencing moderate to severe hot flashes as a result of VMS and menopause, it's a giant, it's a large market and a big unmet medical need. Do we have the opportunity for differentiation?
We're the first in class monoclonal antibody. We see an opportunity, especially in the dosing regimen.
Mm-hmm.
From the studies that we have done, we see that the majority of women actually would prefer a monthly injectable to a daily oral. That's if safety and efficacy are equivalent. We have reason to believe why we might be safer than the small molecules. You know, clinical data will tell us if we've got more efficacy. Lastly, the clinical development path, actually, it's a very straightforward clinical development path. With a single injection, we expect to see, we have strong biomarkers that we will test in phase I. We do also, as a part of our phase I, have a proof of concept study that is being done on post-menopausal women experiencing moderate to severe hot flashes.
Without a lot of outlay of capital, we are going to be able to see a signal which will give us real conviction that this antibody is going to eventually be a drug.
Mm-hmm.
I can go into any one of those.
Yeah, no, let's hit them all. I guess on the scheduling side, you know, you talked about this being once monthly. It is a half-life extended antibody. Do you think that there's maybe an opportunity to even extend the frequency of administration beyond a month?
Yeah, it is possible. Right now, our target product profile is for a monthly subcutaneous injection with an auto injector.
Mm-hmm.
We think that that would fit, and be well, well received by the market. That as a source of differentiation, I think it's a great source of differentiation. Just to go back to these statistics, we polled a number of women who are experiencing hot flashes and asked if they, what they would prefer, either a daily oral or a monthly injectable. Over 50% of women said that they would prefer the monthly injectable. When you segmented that to women who have experience with needles or injectables, either through diabetes or GLP-1s or any other type of subcutaneous treatment, it's over 75% that preferred the injectable. With the increased use of GLP-1s, maybe that would, you know, skew the entire field to vastly preferring a monthly injectable over a daily oral. That's a real opportunity.
The one thing I did not talk about in terms of our framework of, you know, the science, the commercial opportunity, the differentiation, the commercial development path, and it leads to the investments we have made in the platform, is that the novelty on this one and the ability for others to follow, it is an antibody against a GPCR target that hits a part of the brain that is not normally, not normally do you go after antibodies even for trying to hit a target in this part of the brain, and it is a GPCR target. We think we have quite a differentiated asset here that played to our strengths of the years of investment in technology.
Mm-hmm. I would imagine CNS penetrance is maybe one of the first things that folks are trying to screen out for, actually, right?
Yeah. Actually, we have said quite clearly, and I think that the major risk on this program is target engagement.
Mm-hmm.
Can we engage the target? We are going to find that out in the phase I. Again, that lends itself to this conviction on the clinical development path for not very much capital. We are going to get good biomarker data and then also see if the engagement of the NK3R, neurokinin 3 receptor, is sufficient to lower hot flashes by kind of in the middle of next year. Engaging that part of the brain and engaging it sufficiently to actually be able to send the signal past the blood-brain barrier to the thermoregulatory spot of the brain is the major risk in this program. That kind of broadly is the target engagement. We will know by the middle of next year, which is a very exciting time for AbCellera.
Okay. Maybe you talk a little bit about the phase I. I know that's being done in development with this grant, I think it is with the Canadian government.
That's right.
Maybe you can just talk about how many patients, how you expect the utilization of Canadian trial sites to impact or not impact the pace at which you can enroll patients. Then maybe you can just talk a little bit about the biomarker that you're going to be looking at, that's going to allow you to claim proof of concept sometime next year.
Yeah. The, you alluded to this government, Government of Canada and Government of British Columbia funding that we received. This was announced in 2023. This is an opportunity for us to get government funding in order to help build the clinical trials ecosystem in Canada, certainly for early phase clinical trials. Where we get essentially CAD 0.45 back on the dollar, provided the activities are done in Canada. This is for discovery and development, to the end of phase I. Both our ABCL575 and our ABCL635 programs, we're advancing with Health Canada through the clinical trials, through getting a CTA and then establishing, you know, our key opinion leaders there and then our clinical trial sites. That has been going extremely well.
It turns out that there are great key opinion leaders and trial sites and CROs available in Quebec specifically and also in Ontario. We are establishing sites in British Columbia for these trials. It has not been any impediment to the progression of the trial, which has been excellent, including going through Health Canada. Their treatment of the submission was, you know, as you would expect and with no delays that we experienced there whatsoever. It has all gone extremely well. Recruitment and establishing these sites and recruitment also has gone off thus far, you know, without a hitch.
Mm-hmm.
We have managed to, you know, start our recruitment on site, site initiation and recruitment on schedule as we had planned. What that meant was we separated the phase I into both a single ascending dose and a multi-ascending dose to test for biomarkers. We're looking for, we have recruited both healthy males and females because the primary biomarker we're looking at is reduction in testosterone. If we engage the target, it's our expectation to knock down testosterone. It's a very easy biomarker to test.
Mm-hmm.
We will see that through our single ascending dose, which is, that's the part of the trial that we've been initiating thus far. It's, everything's been going to plan and it's on track. We would expect to finish those dosing, but then have to follow the patients for some time, I think by the end of the year or the early part of next year and be able to start the proof of concept study.
Mm-hmm.
Which are in about 60 or 80 patients. The first study is also in about 60 or 80. I think the grand total is about 140 patients in the phase I, in the phase I plus this proof of concept that's being done under the phase I registration. That proof of concept study with post-menopausal women experiencing moderate to severe hot flashes would start in the new year with a single dose. Then we would follow and have them keep a record to see if we get a reduction in the frequency and severity of the hot flashes.
Okay. The disclosure that you guys have been guiding to some point next year, that will include that 60-80 patients worth of proof of concept data.
That's correct. Yeah. Importantly there, and it's something we really like about this program and the opportunity, the competition, let's say, is also helping to grow the market. These small molecules, first of all, you, there was even some news just last week regarding treatments for menopause and specifically that the hormone replacement therapy that's had a black box warning for some time.
Yeah, they removed the box.
Was removed, which is excellent, I think, because actually hormone replacement therapy is quite a good, is a good therapy, when you look into it. It has been definitely been suppressed since the Women's Health Initiative in the early 2000s, came out with these extended risk factors, or black box warning.
Mm-hmm.
There are, of course, risk factors associated with hormone replacement therapy. Many women are contraindicated. About 12% of women are contraindicated, or, sorry, have the risk factors associated with getting hormone replacement therapy. Another about 8% do not tolerate it for some reason and have to stop, you know, stop receiving the hormone replacement therapy. That is about 20% of the population who do not have hormone replacement therapy as an option.
Mm-hmm.
There are many who certainly have some reservations about taking hormone replacement therapy. That is already a large number of women. We estimate about 1.2 million patients in that contraindicated kind of segment. Now that opens up an opportunity for non-hormonal treatments for hot flashes associated with menopause. Astellas has launched, excuse me, VEOZAH.
Mm-hmm.
Just recently, Bayer got an FDA approval for Lynkuet. Now, Astellas, the VEOZAH does have a black box warning on it for liver toxicity and required liver testing, and, but still have been increasing the prescriptions and they're doing a good job at establishing the market.
I was surprised, I guess, to see that that drug was already annualizing, I think like $200 million-$300 million.
That's right. Yeah. It goes to show you the large unmet medical need, even with the box warning.
Even with a flawed product.
Yeah. With the safety, you know, liver toxicity is a, you know, a serious issue and, you know, it shows you how much there is an unmet medical need here. Now the Bayer molecule, Lynkuet, they're quite excited about. They are anticipating at least CAD 1 billion in annual sales, which is not too difficult to imagine. I mentioned that about 1.2 million women are contraindicated or cannot for one reason or another take hormone replacement therapy. The net price on the small molecule is about, say, CAD 5,000, CAD 4,500-CAD 5,000. That is already like a CAD 6 billion addressable market.
Mm-hmm.
Bayer saying they would take, you know, a billion of that. I think if anything, it's a, it's a conservative estimate.
Mm-hmm.
We're very happy and rooting for both Bayer and Astellas' success here because they're building the market and the awareness for non-hormonal options for the treatment of hot flashes. We think if we can come in some five or six years later with a molecule, hopefully we'll see has superior efficacy and certainly isn't expected to see the safety signal of liver toxicity or the Bayer molecule, because it is both an NK1R and NK3R acting molecule, does have a signal of somnolence. There is a warning on the label of sleepiness or drowsiness.
Mm-hmm.
If we were able to come in with a molecule that has at least the same efficacy without either of those safety signals, and ideally even better efficacy and differentiated on dosing, which we think would be preferred by women, we think that's a good setup, particularly if Astellas and Bayer have spent a good number of years helping to build the market for these non-hormonal options.
Can you remind us what the registrational programs for those assets look like? And just in terms of like resourcing patient numbers.
Yeah. In terms of the phase II phase III, I don't have that number on the top of my head. Actually, we've just hired a new Chief Medical Officer, Sarah Noonberg, who would be anxious to introduce you to. She is working on a lot of those details now.
Okay.
I don't want to get ahead of that, but certainly for the next time we speak, or that is a focus of her efforts at the moment is trying to think about what do those later stage trials look like.
Yeah. It would just be interesting to think about, you know, the opportunity for you to be able to retain more of that value, maybe kind of push this a little bit further through the clinic.
Absolutely. We definitely have the conviction to do the phase II. A big question mark we have is the commercial channel here is quite diverse and, you know, one where it'd be a real challenge for us to come up with the capital to build out the reach into all these OB/GYNs or even primary care doctors who might feel comfortable prescribing a, a monthly injectable, where they, we do know there's some reticence to primary care doctors prescribing hormone replacement therapy. Normally that's reserved for OB/GYN, you know, specialists. That is a, you know, there's a lot of water between here and there, but that is a consideration for that program.
Okay. Maybe we could touch on ABCL575. So this is the OX40 ligand antagonist.
Yeah.
I guess what's your approach here? Maybe you can kind of compare and contrast what has been talked about in terms of the advantages of targeting the ligand itself versus a lot of the other assets which actually have been targeting the receptor directly.
Yeah. I think this OX40, OX40 ligand pathway is like upstream of some of these other pathways that are blocked in INI indications specifically by lebri and dupi. The idea there is that this might be more effective in treating some of these INI conditions. Certainly on the OX40 ligand case, Sanofi is leading the charge. On the OX40 case, you know, you've got Amgen and rocatinlimab that's been out there. Now, rocatinlimab, in addition to blocking OX40, is a depleting antibody.
Mm-hmm.
It has had some side effects with fever and chills and things. You know, that's more effect of the depleting antibody than it maybe is of that pathway. I think our contention has been blocking the pathway either should work, but roca has got these additional side effects from being a depleting antibody. What we do see, and since we spoke last, we've seen some extra data from Sanofi. Actually, we thought that the data was quite encouraging. It definitely showed that this pathway works, that it is safe, that it is very long lasting.
Mm-hmm.
Very slow onset. Their four week and their 12 week dosing showed basically the same efficacy, or this versus placebo, at the six month period.
Yeah.
Not yet better than Dupixent, but it was not clear as well how that trial was designed and were they treating, you know, people who are unresponsive to Dupi. There were a lot of details that were not in there, but importantly it was still showing improvement at this. It had not been asymptotically kind of approaching some limit. It was still on a pretty steep curve. It just showed that it still was too early, which actually bodes well for some of these chronic conditions. You know, they said that they would show more data six months from now. I think those things are, there are some positives in there, certainly for the class that this will be. This could be a giant class, not only for atopic dermatitis, but for asthma and alopecia.
It's being tried in a number of different indications, including in combination. What we'll see is the later data from Sanofi about six months from now. We think that's positive. Where it actually challenged us is we had differentiated, we believe we have a beautiful molecule. It has a longer half life than the amlitelimab molecule, which is from Sanofi. Given the data that they have, this value of differentiation is perhaps diminished because there, it looks like they're already going to get quarterly dosing.
Yep.
Why we believe we're going to get six month dosing, our modeling would suggest how differentiated is that. Is quarterly, you know, an okay frequency for the dosing, or how much differentiation is six month dosing if you have a quarterly asset? It's still early days. It also is getting advanced through the funding mechanism we have in the Canadian government. It's not that much capital to keep that program alive and wait to see the major card flip from Sanofi with amlitelimab.
Okay. I know you kind of just talked about the new IND candidate, ABCL688.
That's right.
Eight.
688.
I know early, but is there anything that you can say about, you know, the biology, not necessarily the target, but.
I just say it's similar to ABCL635. It's one that uses our discovery capabilities against GPCR targets, say ion channel and GPCR targets. I would just say, look, mid next year is when we expect to be bringing that into a CTA. In Canada again, and we'll disclose more about that target at that time.
Okay. And maybe just lastly, you know, what does the balance sheet look like and what does that allow you to execute on?
Yeah, the balance sheet. We just had our Q3 earnings, you know, over CAD 500 million in cash and equivalents and still just under CAD 200 million in available liquidity from this government spending. That brings us to a very healthy, you know, around CAD 700 million in total available liquidity. That does not include the fact that we have been the bank funding the buildings that we're in, the research building, and we didn't get to talk about the GMP manufacturing, but maybe for another time. It puts us in a place where we have sufficient liquidity for at least the next three years. You've been following the story for a long time, and I think we've been saying we have at least three years of liquidity for at least five years now.
Yeah.
I hope that'll continue.
All right. It was very good catching up, Andrew. I appreciate the time. Thanks.
Thanks, Steve. Yeah.
Thanks everyone .