AbCellera Biologics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2025
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Operator

Good afternoon, and welcome to the AppSellers First Quarter twenty twenty five Business Update and Conference Call. My name is Jasmine, and I will facilitate the audio portion of today's interactive broadcast. All lines will be muted during the presentation portion of the call with the opportunity for questions and answers at the end. At this time, I would like to turn the call over to Trans Starmart, Absolute, Chief Legal and Compliance Officer. You may proceed.

Tryn Stimart
Tryn Stimart
Chief Legal Officer, CCO, Compliance Officer, Corporate Secretary & Privacy Officer at AbCellera Biologics

Thank you. Hello, everyone. Thank you for joining us for Acelora's first quarter twenty twenty five earnings call. I'm Trent Steinmart, Acelora's Chief Legal and Compliance Officer Doctor. Carl Hansen, Acelora's President and Chief Executive and Andrew Booth, Ibselra's Chief Financial Officer are joining me on today's call.

Tryn Stimart
Tryn Stimart
Chief Legal Officer, CCO, Compliance Officer, Corporate Secretary & Privacy Officer at AbCellera Biologics

During this call, we anticipate making projections and forward looking statements based on our current expectations and according to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially due to several factors outlined in our latest Form 10 ks and subsequent Forms 10 Q and eight ks filed with the Securities and Exchange Commission. Absellor is not obligated to update any forward looking statements, whether due to new information, future events or otherwise. Our presentation today, including our earnings press release and SEC filings published earlier today, are available on our Investor Relations website. The information we provide about our pipeline is for the benefit of the investment community and is not intended to be promotional.

Tryn Stimart
Tryn Stimart
Chief Legal Officer, CCO, Compliance Officer, Corporate Secretary & Privacy Officer at AbCellera Biologics

As we transition to our prepared remarks, please note that all dollars referred to during the call are U. S. Dollars. After our prepared remarks, we will open the lines for questions and answers. Now I'll turn the call over to Carl.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Thanks, Quinn, and thank you, everyone, for joining us today. This first quarter, we continue to execute against our key priorities for 2025, which include initiating Phase I clinical trials for ABCL635 and ABCL575, nominating one or more additional development candidates and moving these into CTA enabling studies, completing platform investments, and starting to use our clinical manufacturing capabilities. Today, my prepared remarks are focused on providing additional details about ABCL635, including revealing its target and indication for the first time. ABCL635 is a potential first in class therapeutic antibody being developed for non hormonal treatment of moderate to severe vasomotor symptoms, more commonly known as hot flashes, that are associated with menopause. ABCL635 targets neurokinin-three receptor, or NKTR, which is a GPCR involved in endocrine homeostasis and thermoregulation.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Notably, ABCL635 is the first program from our GPCR and Ion Channels platform to advance into our pipeline. On our last earnings call, we discussed how we assess program investment decisions, and this slide summarizes our view of ABCL635 in each of the four dimensions of our investment framework. First, starting with the science, the NKTR pathway is well understood and has been clinically validated with small molecules, giving us high confidence in the biology. Accordingly, we believe the main scientific risk for ABCL635 is whether or not we can achieve sufficient target engagement. From a commercial perspective, BMS associated with menopause presents a large unmet medical need and a significant market opportunity.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Approximately thirty percent of women experience moderate to severe BMS at some point in their lives, with more than half seeking treatment. ABCL635 has the potential to be the first antibody therapy in the NKTR class, a market estimated to reach over $2,000,000,000 in annual sales. With respect to differentiation, ABCL635 has the potential to be a first in class antibody treatment for BMS with dosing every four weeks and an improved safety profile as compared to small molecules. And finally, this program has a well established development path with potential for important early readouts on biomarkers and efficacy. VMS represents an underserved, underappreciated, and serious unmet medical need.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

They impact the well-being, the productivity, the career advancement, and the income of millions of women in North America alone. In The United States, there are approximately forty million women of menopausal age. BMS are the most common symptoms of menopause, and as I noted earlier, about thirty percent of women will experience moderate to severe BMS in their lifetimes. The median duration of BMS is seven and a half years. Approximately twelve percent of women will experience symptoms for more than ten years.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

And in some cases, BMS can last for decades. This is why new treatments for BMS are an important addition to available therapies for women who suffer from this serious and long overlooked condition. Menopause hormone therapy, or MHT, is recognized as an effective treatment for BMS and is the current standard of care. While effective, MHT is not for everyone. Approximately twelve percent of women are contraindicated for MHT, and eight percent of women who begin MHT discontinue within twelve months.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Additionally, in a recent global study, it was found that fifty seven percent of women who were eligible for MHT were against using it. Non hormonal treatments for VMS are therefore an important option for women who either cannot or who choose not to use MHT. NKTR antagonists have recently been proven as effective non hormonal options for the treatment of VMS. NK3R is a GPCR protein expressed by candy neurons that are located in the infundibular nucleus, also known as the arcuate nucleus, which is a region of the hypothalamus. Candy neurons play a central role in regulating endocrine reproductive function and also impact thermal regulatory control via an interdependent neuronal pathway.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Prior to menopause, candy neuronal activity is balanced by stimulatory NKBNK3R signaling and the inhibitory effect of estrogen. In menopause, when estrogen levels decrease due to the natural process of reproductive aging, this neural activity becomes unbalanced. As a result, NKB increasingly binds NK3R, causing candy neurons to over activate and stimulate the thermoregulatory neurons in another region of the brain, called the preoptic nucleus, which leads to hot flashes. ABCL635 was designed to bind to NK3R and to prevent the activation of candy neurons by NKB. Blocking NKBNK3R signaling with small molecules has been clinically shown to reduce both the frequency and severity of BMS associated with menopause.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Importantly, the infundibular nucleus responds to soluble factors in the blood and is therefore one of the few specialized areas of the brain that is not isolated behind the blood brain barrier. Because of this, we believe that ABCL635 should be able to engage NKTR on Kandi neurons, and our preclinical studies support this hypothesis. Translating this result into humans and confirming that target engagement is sufficient to reduce BMS is the key scientific risk in this program. There are two small molecule NKTR antagonists that have recently been demonstrated clinically to be both safe and effective. Therefore, ABCL635 has the potential to enter the market at a time when the class has already been established and small molecules are approaching peak sales.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Fezolinetant, a once daily oral treatment, was approved in May of twenty twenty three and is the first available NKTR antagonist for the treatment of BMS. Elenzanatant, also a once daily oral treatment, successfully completed phase three trials and is expected to be approved within the year. Unlike fezalinotant, elenzanotant is a nonselective antagonist that blocks both NKTR and a related receptor, NKTR. Because ABCL635 is an NKTR specific antibody, we expect that it will avoid some side effects that have been observed with small molecules in the clinic. First, unlike small molecules that are metabolized in the liver, antibodies are generally not associated with liver toxicity.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

And second, because ABCL635 is specific to NKTR, we do not expect fatigue or somnolence that is believed to be related to the antagonism of NKTR. In addition to having potential for an improved safety profile, we also believe ABCL635 can achieve convenient dosing that would be preferred by a large fraction of women with BMS. To confirm this, we conducted a market research survey of 75 women who have BMS and found that, assuming equal efficacy and safety profiles, more than fifty percent said they would prefer the convenience of a once monthly injectable over a daily oral treatment. In addition, for the subset of women with experience using auto injectors, a large majority, approximately seventy percent, said they would select a once monthly injectable over a daily pill. In summary, the recent and upcoming approvals of novel non hormonal treatments for BMS are an important and long overdue solution for millions of women.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

ABCL635 is being developed as a next generation NKTR antagonist with both an improved safety profile and a more convenient dosing regimen. If ultimately successful, we believe it can be a highly differentiated product that is launched into a large and established market. In terms of timing, our plans include completing the CTA process this quarter, starting our Phase I study in Q3 of twenty twenty five, and reporting key readouts of safety and early efficacy in mid-twenty twenty six. As ABCL635 goes into clinical trials, we have high conviction in the biology, the differentiation thesis, and the unmet medical need. We expect the most important risk regarding target engagement will be addressed in Phase one, making this an important near term clinical readout.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Turning to our second program, we have been advancing ABCL-five seventy five concurrently with ABCL-six thirty five. It is also on track with a CTA filing in Q2, and we anticipate starting Phase I clinical trials in the third quarter. Later this week, our team will be in San Diego presenting preclinical data on ABCL-five seventy five at the annual meeting of the Society for Investigative Dermatology. You can download the poster presentation on our website when it becomes available tomorrow, May 9. With our first two programs nearing the clinic, our transition from a platform company to a clinical stage biotech is nearly complete.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Behind ABCL635 and ABCL575, we are working on a portfolio of more than 20 internal and co development programs from which we will continue to build our pipeline. As mentioned earlier, ABCL635 will be the first clinical program derived from our GPCR and I'm channels platform. We view this as an important proof point that our technology can unlock these challenging and high value target classes, which represent approximately half of our preclinical programs. We expect to elect an additional development candidate from this platform in the near future and look forward to sharing updates with you as they become available. Similarly, we see our T cell engager platform as a source of internal programs and also as a basis for future partnering activities.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Last month, we provided an update on our TCE platform, including in vivo data that was presented at AACR's annual meeting. And finally, investments in building our clinical manufacturing are on track and are nearing completion. We expect to start using these capabilities later this year. And with that, I will hand over to Andrew to discuss our financials. Andrew?

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

Thanks, Karl. As Karl pointed out, Absella continues to be in a strong liquidity position with approximately $630,000,000 in cash and equivalents and with roughly $180,000,000 in available committed government funding to continue to execute on our strategy. We are continuing our plans with a focus on internal programs and completing our CMC and GMP investments. Looking at our key business metrics. In the fourth quarter, we started to work on one partner initiated program, which takes us to a cumulative total of 97 programs with downstream participation.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

We saw no new molecules advancing into the clinic in the quarter, maintaining our cumulative total of 16 molecules to have reached the clinic. And we understand the development of the four Triany licensed molecules that Novorock advanced into Phase one are currently paused. As we have stated previously, we view the overall progress of molecules in the clinic as a potential source of near and mid term revenue from downstream milestone fees and royalty payments in the longer term. Turning to revenue and expenses. Revenue for the quarter was about $4,000,000 mostly driven by research fees relating to the work on partnered programs.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

This compares to revenue of $10,000,000 in the same quarter of 2024. As we have mentioned in the past, we expect research fee revenue to continue to trend lower as we increasingly focus on internal and co development programs. Our research and development expenses for the quarter were approximately CAD43 million, CAD3 million more than last year. This expense is driven by increasing investment in our internal and co development programs. In sales and marketing, expenses for Q1 were about $3,000,000 a modest reduction relative to the same quarter last year.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

And in general and administration, expenses were approximately $16,000,000 compared to roughly $17,000,000 in Q1 of twenty twenty four. Looking at earnings, we are reporting a net loss of roughly $46,000,000 for the quarter compared to a loss of around $41,000,000 in the same quarter last year. In terms of earnings per share, this result works out to a loss of CAD0.15 per share on a basic and diluted basis. Looking at cash flows. Operating activities for Q1 of twenty twenty five used approximately $12,000,000 in cash and equivalents.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

Excluding investments in marketable securities, investment activities amounted to a net $17,000,000 mostly in property, plant and equipment driven by our ongoing work to establish CMC and GMP manufacturing capabilities. The investments in PP and E were partially offset by government contributions. And as a part of our treasury strategy, we have nearly $450,000,000 invested in short term marketable securities. Our investment activities for the quarter included approximately $25,000,000 net decrease in these holdings. Altogether, we finished the quarter with over $630,000,000 of total cash, cash equivalents and marketable securities.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

As a reminder, we have received commitments for funding for our GMP facility and for the advancement of our internal pipeline from the Government of Canada's Strategic Innovation Fund and the Government of British Columbia. This available capital does not show up on our balance sheet. With over $630,000,000 in cash and equivalents and the unused portion of our secured government funding, we have approximately $810,000,000 in total available liquidity to continue executing on our strategy. The cash usage for the remainder of 2025 will continue to prioritize advancing our two lead programs to the clinic, building the preclinical pipeline and completing our investment in the integrated CMC and GMP capabilities. As previously communicated, the new manufacturing facility is scheduled to come online at the end of twenty twenty five.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

With respect to our overall operating expenses, our capital needs are very manageable. We continue to believe that we have sufficient liquidity to fund well beyond the next three years of increasing pipeline investments. And with that, we'll be happy to take questions.

Operator

Thank you. We will now begin the Q and A portion of the call. You. We will pause here briefly if questions are registered. Our first question comes from Brendan Smith with TD Securities. You may now proceed.

Jacqueline Kisa
Equity Research Associate at TD Cowen

Hi. This is Jackie on for Brendan. Congrats on the quarter and thank you for taking my question. Maybe just a quick one on June. What do you expect this asset needs to see in terms of Phase one data and any follow-up data to really capture that competitive edge given the head start that peers have you know, going beyond just, you know, that it's more, of a a nicer dose than the preferred, kind of type of medicine?

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Sure. I'm happy to take that question. Carl here. So, obviously, you know, there's, some recent activity in the approval of NKTR antagonist with fezlanetant and elenzanetant. That's a terrific outcome for patients that are looking for nonhormonal treatments.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

We view the validation and the success of those molecules as very positive for this program. There's going to be some time required to communicate to medical practitioners and patients and to start to build the class. And we are positioned with a molecule that would, take advantage of that growing awareness and would be positioned, if it is successful, to launch into what has become a large and established class. In terms of, you know, what we need to see in the phase one, studies, we haven't disclosed the design of those studies, but we will be looking, of course, at safety, but also at some very important data on biomarkers, which are an early sign of target engagement, and, on the latter part of the study, evaluating efficacy in a a population of participants. So one of the really attractive things about this program is that, you know, by midpoint next year, we should have data, that tells us a lot about, the success of the program and the science.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

And with that, we'd be in a position to double down and to invest further. From a differentiation perspective, which was, you know, related to or or part of your question, really, it's two things. The first is we do believe that an antibody that is specific to NKTR can have a cleaner safety profile, which is something that, that we believe is highly valued and differentiated. And perhaps even more in differentiation is the dosing. As mentioned in my prepared remarks, we we have conducted a study that shows that, a majority of women would prefer to have a once monthly subcutaneous self administered injection over a daily pill.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

And for women that have experience with auto injectors, that number, goes up to about seventy percent. With the growing use of auto injectors, particularly in the GLP-one class, we see that as a trend that's going to continue, to grow over time. It's a matter of convenience. It's a matter of compliance. And, you know, people that, that have busy lives, would prefer to have something that is, you know, something you do once a month, then you don't have to worry about it after that.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

If we, are successful of course, we're just at the very beginning of this, so, you know, our our eyes are laser focused on getting this early data. But if successful, again, it launches into a large class, and we think that there's a significant population, in fact, the majority that would prefer that format.

Jacqueline Kisa
Equity Research Associate at TD Cowen

Yeah. That's very helpful. Thank you. And then maybe one just quick one. What should we expect to see from the upcoming five seventy five preclinical data tomorrow, presented at the medical meeting?

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Sure. Yeah. So, we are we are presenting at SID, as I mentioned. You know, the preclinical data will include, you know, some early, early animal work that supported the filing, and probably the most important data is the first glimpse at, PK analysis, and predictions of what that would lead to in human studies. The main, pillar of differentiation for a b c l five seven five is that we believe it will be, differentiated in having a superior dosing regimen, and we're aiming for having, you know, at least three months, if not six months, dosing, and are optimistic that, that you'll be pleased with the data when you see it.

Jacqueline Kisa
Equity Research Associate at TD Cowen

Great. Thank you so much. Thank

Operator

you. Our next question comes from Andrea Newkart with Goldman Sachs. You may now proceed.

Analyst

Hi, all. This is Tawani on for Andrea. Thanks for taking the questions and congrats on the progress. Just one another quick one on June. Given the risk you had mentioned facing the program around translatability of the NKTR engagement from the preclinical studies into humans, is there a precedent you could point to that gives you confidence that those observations will still hold in the clinical setting?

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

That's a great question. So, you know, we have, we have preclinical data, including data, on NHP that give us, you know, a lot of reason to be optimistic that this will translate into humans. And so I I I think I am being, circumspect largely because drug development is a humbling industry, and you're often surprised. And, of course, non nonhuman primates are not humans, so it needs to be shown there. In terms of precedent, you know, there are, there are some antibodies, I believe, you know, CGRP receptor, that are in a similar part of the brain, so there is some precedent.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

But, you know, this is a different pathway, and, the details of where the neurons are in that part of the brain. And and, of course, you know, behind that, whether or not we have complete understanding of the pathway, which we believe we do, but sometimes you can be surprised, all of those things need to be derisked. And the important thing for ABCL635 is that the development path allows us to test, both of those main risks, early in clinical development through a biomarker readout and early efficacy. So it's not that I would bet against it, but I think in all drug development, we should be cautious and not assume that things are going to translate directly from nonhuman primate to humans.

Analyst

Okay. Understood. Thank you. And then just one more, if I may. With both May and six thirty five now advancing into the clinic, how are you thinking about the next development candidates?

Analyst

And is there any line of sight at the time as to what targets or indications might be selected or of interest?

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Sure. I'll I'll take that one again. Yeah. So we are, you know, building our our portfolio and making investment decisions according to the framework that I outlined in some detail in the last earnings call and that I alluded to at the start at the start today. Basically, we're looking for high conviction biology, with a large unmet medical need, a compelling case for differentiation, and importantly, a development path that allows us to get as much information as quickly as possible, and it doesn't pose, you know, undue risk or require a huge amount of time and money to get those early answers.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Beyond that, we are target agnostic. So we have been looking broadly across indications, broadly across biology to look for opportunities that we're excited about. Substantial portion of that effort has brought us to the difficult target classes, so ion channels and GPCRs. And as I said in my prepared remarks, it's likely that the next development candidate that will come up will be another one that is either a GPCR or ion channel that builds on what has been years of technology and capability building to unlock that class, and we're we're quite excited about that. Typically, we will not be discussing targets or indications, until a program has moved at least to development candidate.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

And once it is a development candidate, we will disclose, the indication and the target if we believe that that is strategically wise, and we will avoid doing that if we think that, there's downside in terms of competition. And so depending on what the target is, we'll either, disclose very early as we did with May, or we will hold it closer to our chest and, disclose it, closer to CPA filing as we have done with m k three r.

Analyst

Makes sense. Thank you.

Operator

Our next question comes from Puneet Souda with Leerink Partners. You may now proceed.

Puneet Souda
Senior MD at Leerink Partners

My first one has to do with the $5.75 asset. So during the quarter, we saw some updates from rocotinlimab as well as amlutelimab in asthma. I was wondering if you had any comments on how those readouts, inform, your updated view of the, opportunities for this particular asset?

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Yes. Carl here. I'm I'm happy to take that one. Thanks for the question, Puneet. So, you know, first of all, you know, our our investment thesis in May is, is reinforced by the the hypothesis that the aux 40 ligand class is going to be a huge class, important not just in atopic dermatitis, which is, obviously a huge market, but also we'll find applications across other indications.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Over the last quarter, I think there's been, you know, several points that confirm and reinforce that hypothesis. So, there is the the Sanofi trial, in asthma. And while, they did not, read out on the top line, there was a subset of patients for which they got seventy percent responses, which is excellent. That subset of patients are the patients with high eosinophil counts, which is the same patient group, for which Dupixent is being used. And so we view that as a very strong positive signal that OX40 ligand is going to have applications and be an important, an important therapeutic option in asthma.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

And, of course, you know, Sanofi has put their money where their mouth is. They are advancing that into phase three. So we see that as a very positive outcome. In addition to that, there was a readout, for another OX40 OX40 ligand molecule from, Imogene, with some early efficacy in alopecia, which, again, highlights that OX40 ligand will have applications broadly in INI. And while it has not been, widely, covered, Sanofi has decided to advance an OX40 ligand TNF alpha bispecific for HS.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

So that is another example of ox 40 ligand being important in HS, and also reinforces a second pillar of our investment thesis, which is that ox 40 ligand is a particularly good pathway or ox 40 ox 40 ligand is a particularly good pathway for combination therapy. You asked also about, rocotinlimab. They've released additional data. I I mean, I would say that, the data is disappointing, compared to, what has been seen with amatilumab. It's not clear if that is a reflection of the difference between targeting OX40 ligand and OX40 or if it's a difference, with the mechanism of action because rockatilimab is, of course, a depleting antibody, whereas we have an Fc effector, null, variant, which will not deplete, cells.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

So all of that we view as being, very positive and a tailwind for the program. You know, in in our shop, we're currently focused on getting, the early phase one data. The most important part of that is gonna be demonstrating, the long extended PK. And then a lot of the big catalysts are gonna come from outside Bebcellera and examples of the aux 40, aux 40 ligand class working in other indications or working in combination, are things that we believe, you know, add value to that program and make it more attractive, going forward. So we're keeping an eye an eye on that just like you are.

Puneet Souda
Senior MD at Leerink Partners

Okay. And then I have one that maybe a bit of a deep cut, but, given pharma tariffs, there's been a lot of talk about where IP gets domiciled, as a Canada based company. I was wondering if that becomes an element of a discussion when you're thinking about spinning off assets to potential partners.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

Hey, thanks. It's Andrew here. I think at the moment, we haven't had a discussion in terms of spinning off assets. We have our intellectual property up here in Canada. And for now, it remains a good jurisdiction for us to hold intellectual property. So we haven't had many discussions further than that.

Puneet Souda
Senior MD at Leerink Partners

Got it. Thank you.

Operator

Thank you. Our next question comes from Malcolm Hoffman with BMO. You may now proceed.

Malcolm Hoffman
Malcolm Hoffman
Senior BioPharma Equity Research Associate at BMO Capital Markets

Mark Hoffman on for Evan Seigerman from BMO. You called up for Novorok molecules in the clinic that have been paused. Can you provide some more context to this pause and what it means for future development? And then kind of extending off the conversation around IP and tariffs, I know a decent amount of the manufacturing capabilities for cellular are based in Canada. Is there any consideration for potentially producing U.

Malcolm Hoffman
Malcolm Hoffman
Senior BioPharma Equity Research Associate at BMO Capital Markets

S.-based manufacturing redundancies to kind of address that potential risk in the future? Thank you.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

Yes. Sure. I'm happy to take that one. With regard to the Novorok molecules, think we just thought it prudent to disclose what we had seen on their own website. We believe it's related to fundraising, which is not uncommon in the present current in the present environment for them to complete fundraising in order to continue those trials.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

But we'll keep an eye on that and give any updates as we see it. With regards to the manufacturing facility, we do have this manufacturing facility in Canada. Right now, we are we have built this manufacturing facility in order to support us in our phase one, phase two clinical trials. So still during research phase of manufacturing the product. And as you know, as we have mentioned, our first two molecules, we are advancing them through to CTA in Canada.

Andrew Booth
Andrew Booth
CFO at AbCellera Biologics

But even as it's still even if we start trials in The United States, I don't believe it will be an issue in moving those products over the border in order to conduct those clinical trials. We haven't given any thought. It's still quite early to think about when we get to commercial when we think about commercial manufacturing for any of these molecules where that might be done and that's still a topic for much in the distant future.

Malcolm Hoffman
Malcolm Hoffman
Senior BioPharma Equity Research Associate at BMO Capital Markets

Appreciate it. Thanks guys.

Operator

Thank you. Our next question comes from Kripa Devarakonda with Truist. You may now proceed.

Kripa Devarakonda
Kripa Devarakonda
Vice President - Biotechnology Equity Research at Truist Securities

Hey guys. Congrats on all the progress and thank you so much for taking my question. I know you've not yet talked about trial design, but as you go through your planning, I was wondering if there are any specific learnings from all the other trials relevant to June that have already been done, that can help you, optimize your trials. And also, if I'm not mistaken, this this, you know, as a target has had NKTR has had a long history in terms of drug development with earlier trials focused on neuropsychiatry. Wondering if there's good enough understanding and if that could be, I know it's really early stages, but if there is a potential to expand beyond VMS? Thank you.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Carl here. I'll take that. I'm actually not aware of the development of NKTR in, neurological indications. I think there is some precedent for NKTR, which is the second target that is hit by ozanatant. Beyond that, I don't think I'd be able to comment.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Coming back to the development path, it is a big advantage that there is a clear development path that has now been successfully navigated by two products. So it's it's obvious what the final endpoints should be, the patient population, how to set that up. So we have an advantage from that perspective in that we, we don't have a lot of ambiguity as to what will be the bar for getting approval, of ABCL635. We haven't yet, disclosed details of the clinical development plan. But as per my previous comments, you know, our emphasis right now is to design the first trial and not to pull punches so that we can take as much risk off the off the table as soon as possible.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

So we are looking in this first trial, you know, not just to get a look at, safety, which we believe will be will be good, but you always have to prove that, but also to get early evidence from biomarkers on target engagement and an early read on efficacy. So once we have that in hand, then if it looks the way that we hope, we would be working to accelerate the path forward to development. And there's already some thinking and planning around that. But of course, it depends upon regulatory engagement and on the data that we get from the Phase I trial.

Kripa Devarakonda
Kripa Devarakonda
Vice President - Biotechnology Equity Research at Truist Securities

Great. Thank you so much.

Operator

Thank you. Our next question comes from Stephen Wiley with Stifel. You may now proceed.

Analyst

Hey. Thanks for taking our question. This is Josh on for Steve. Quick one on June. In terms of the development plan, do you think you and I know you'd said that you haven't really disclosed the full plan just yet, but do you think you'd have to go into healthy volunteers first, to kind of establish the preliminary PKPD and safety analysis?

Analyst

And then then just to follow-up on some of the questions related to biomarkers and target engagement, could you maybe just provide us with some color on what types of biomarkers you'll be looking at preliminarily to get a sense as to the target engagement here? And then I just have a follow-up.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Sure. Yeah. So, the the short answer is, in the early part of the trial, we will be enrolling healthy volunteers. And, you know, connecting that with your second question, we expect to enroll, both male and female healthy volunteers. And the most reliable biomarker of NKTR engagement would be testosterone levels.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

So that's probably, one of the early readouts that we get, which gives you some strong evidence of target engagement. But, course, that's not conclusive until you can show that that also translates into efficacy.

Analyst

Great. Thank you. And then, just my follow-up was, on the PSMA by CD3 cell engager presentation, you guys made it AACR. Could you just maybe tell us about and I know it's early, but is there anything you could tell us about which format you currently believe can have the best target profile in terms of threading the needle on both, efficacy and safety as it pertains to CRS risk? And then, you know, is this is this, you know, what's the timeline for maybe nominating a development candidate?

Analyst

And is there kind of an appetite for out licensing, with BD, or is this something that you maybe wanna develop internally?

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

Yeah. I'll start with the the question about, about format. And, honestly, that is the the multibillion dollar question that everyone across the industry is trying to answer. You know, at at ACR, as as in previous years, you know, at a high level, there is, increasing, I'd say, accelerating enthusiasm for TCE as a class. A lot of that has been driven by, very exciting data in solid tumors.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

When you talk to all the different groups, it's also apparent that it doesn't look as though there's going to be one technology and one solution that is the magic bullet for every solid tumour or for every target. And many pharma companies and the big players who have committed to the space, and and I would say that list is growing quickly, are placing multiple bets because you need to do these experiments in the clinic to find out what is working. Our approach to this has been to, not cut corners, but to do the hard work to put in place, you know, the tools, the workflows, the assays, to start to systematically investigate, which targets, which formats, which moba which modalities, perhaps even combinations with co stimulation, are going to be needed to get efficacy and tolerable safety in the clinic. And that, you know, that foundation is allowing us to make, in our shop, what I believe is some pretty rapid progress. But we are, of course, only, one company in an ecosystem that's working on this problem, and we're also working with partners, to solve this as well.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

So, when, when we start to get, you know, a hook on the science, or when, the breakthroughs come, we're going to be very well positioned, to capitalize on that. And we're already seeing, you know, some really promising results with some of the internal programs. You asked, if we'd be open to licensing, out licensing, or if we'd bring them into the portfolio, and I think both those options are on the table. I think I said in my prepared remarks, we see this as both a platform for, for building our pipeline as well as for partnering. And we make those decisions based on, you know, the opportunity and the framework that I described in response to the previous question.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

So, TBD there. But, we are increasingly excited about the TC space, and it should be no surprise to anyone that, if the class is to have the promise that everyone believes it does, which is to provide, you know, perhaps not curative, but very meaningful treatments to patients who have no options in cancer, that isn't something that's going to come easily. And it's going to take the combined efforts of many groups in the clinic as well as in the lab. And so that's something we're committed to, and we think it's going to be a long game.

Analyst

Okay. Great. Thank you for taking the questions.

Operator

Thank you. There are no questions waiting at this time. So I'll pass the conference back over to the management team for any further remarks.

Dr. Carl Hansen
Dr. Carl Hansen
Chairman, Chief Executive Officer, and President at AbCellera Biologics

No further remarks. Just thank you, everyone, for joining us today. We're excited about the progress, and looking forward to the next call. Take care.

Operator

That concludes today's conference call. Thank you for your participation. You may now disconnect your line.

Executives
    • Tryn Stimart
      Tryn Stimart
      Chief Legal Officer, CCO, Compliance Officer, Corporate Secretary & Privacy Officer
    • Dr. Carl Hansen
      Dr. Carl Hansen
      Chairman, Chief Executive Officer, and President
    • Andrew Booth
      Andrew Booth
      CFO
Analysts
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Key Takeaways

  • AbCellera is set to initiate Phase I trials for ABCL635 (NK3R‐targeted antibody for menopausal hot flashes) and ABCL575 in Q3 2025, with ABCL635 poised as the first clinical candidate from its GPCR and ion channel platform.
  • ABCL635 aims to be the first monthly injectable nonhormonal therapy for moderate to severe vasomotor symptoms, potentially accessing a >$2 billion market and offering an improved safety profile versus existing small molecules.
  • The company’s transition to a clinical‐stage biotech is nearly complete, with >20 internal and co-development programs—including T-cell engagers—underpinned by its proprietary discovery platforms.
  • Investments in integrated CMC and GMP capabilities are on track, with a new clinical manufacturing facility expected online by end-2025 to support in-house production.
  • Financially, Q1 2025 revenue was $4 million (vs. $10 million Q1 2024), R&D spend was $43 million, and net loss was $46 million; the company holds ~$630 million cash plus $180 million in government funding (~$810 million total liquidity).
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Earnings Conference Call
AbCellera Biologics Q1 2025
00:00 / 00:00

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