AbCellera Biologics Inc. (NASDAQ:ABCL) Q1 2025 Earnings Call Transcript

AbCellera Biologics Inc. (NASDAQ:ABCL) Q1 2025 Earnings Call Transcript May 8, 2025

AbCellera Biologics Inc. beats earnings expectations. Reported EPS is $-0.15, expectations were $-0.17.

Operator: Good afternoon, and welcome to AbCellera’s First Quarter 2025 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 an opportunity for questions-and-answers at the end. [Operator Instructions] At this time, I would like to turn the call over to Tryn Stimart, AbCellera’s Chief Legal and Compliance Officer. You may proceed.

Tryn Stimart: Thank you. Hello, everyone. Thank you for joining us for AbCellera’s first quarter 2025 earnings call. I’m Tryn Stimart, AbCellera’s Chief Legal and Compliance Officer; Dr. Carl Hansen, a AbCellera’s President and Chief Executive Officer; and Andrew Booth, AbCellera’s Chief Financial Officer, are joining me on today’s call. 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-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission.

AbCellera 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. 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.

Carl Hansen: Thanks, Tryn, 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 1 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 3 receptor or NK3R, which is a GPCR involved in endocrine homeostasis and thermoregulation. 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 NK3R 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, VMS associated with menopause presents a large unmet medical need and a significant market opportunity.

Approximately 30% of women experience moderate-to-severe VMS at some point in their lives, with more than half seeking treatment. ABCL635 has the potential to be the first antibody therapy in the NK3R class, a market estimated to reach over $2 billion in annual sales. With respect to differentiation, ABCL635 has the potential to be a first-in-class antibody treatment for VMS, with dosing every 4 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. 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 40 million women of menopausal age. VMS are the most common symptoms of menopause, and as I noted earlier, about 30% of women will experience moderate-to-severe VMS in their lifetimes. The median duration of VMS is 7.5 years, approximately 12% of women will experience symptoms for more than 10 years, and in some cases, VMS can last for decades. This is why new treatments for VMS 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 VMS and is the current standard of care. While effective, MHT is not for everyone: approximately 12% of women are contraindicated for MHT; and 8% of women who begin MHT discontinue within 12 months.

Additionally, in a recent global study, it was found that 57% 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. NK3R antagonists have recently been proven as effective non-hormonal options for the treatment of VMS. NK3R is a GPCR protein expressed by KNDy neurons that are located in the infundibular nucleus, also known as the arcuate nucleus, which is a region of the hypothalamus. KNDy neurons play a central role in regulating endocrine reproductive function and also impact thermal regulatory control via an interdependent neuronal pathway. Prior to menopause, KNDy neuronal activity is balanced by stimulatory NKB/NK3R signaling, and the inhibitory effect of estrogen.

In menopause, when estrogen levels decrease due to the natural process of reproductive aging, this neuronal activity becomes unbalanced. As a result, NKB increasingly binds NK3R, causing KNDy neurons to over-activate and stimulate the thermal regulatory neurons in another region of the brain, called the preoptic nucleus, which leads to hot flashes. ABCL635 was designed to bind NK3R and to prevent the activation of KNDy neurons by NKB. Blocking NKB/NK3R signaling with small molecules has been clinically shown to reduce both the frequency and severity of VMS associated with menopause. 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 NK3R on KNDy neurons, and our preclinical studies support this hypothesis. Translating this result into humans and confirming that target engagement is sufficient to reduce VMS is the key scientific risk in this program. There are two small molecule NK3R 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. Fezolinetant, a once daily oral treatment, was approved in May of 2023 and is the first available NK3R antagonist for the treatment of VMS. Elinzanetant, also a once daily oral treatment, successfully completed Phase 3 trials and is expected to be approved within the year.

Unlike fezolinetant, elinzanetant is a non-selective antagonist that blocks both NK3R and a related receptor, NK1R. Because ABCL635 is an NK3R-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. And second, because ABCL635 is specific to NK3R, we do not expect fatigue or somnolence that is believed to be related to antagonism of NK1R. In addition to having potential for improved safety profile, we also believe ABCL635 can achieve convenient dosing that would be preferred by a large fraction of women with VMS. To confirm this, we conducted a market research survey of 75 women who have VMS and found that, assuming equal efficacy and safety profiles, more than 50% 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 70%, 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 VMS are an important and long overdue solution for millions of women. ABCL635 is being developed as a next generation NK3R 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 1 study in Q3 of 2025, and reporting key readouts of safety and early efficacy in mid-2026.

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 1, making this an important near-term clinical readout. Turning to our second program, we have been advancing ABCL575 concurrently with ABCL635. It is also on track with a CTA filing in Q2, and we anticipate starting Phase 1 clinical trials in the third quarter. Later this week, our team will be in San Diego presenting preclinical data on ABCL575 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 9th. With our first two programs nearing the clinic, our transition from a platform company to a clinical-stage biotech is nearly complete.

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 ion 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.

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: Thanks, Carl. As Carl pointed out, AbCellera continues to be in a strong liquidity position, with approximately $630 million in cash and equivalents and with roughly $180 million 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. 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 Trianni-license molecules that NovaRock advanced into Phase 1 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 million, mostly driven by research fees relating to the work on partnered programs. This compares to revenue of $10 million 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 $43 million, $3 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 million, a modest reduction relative to the same quarter last year. And in general and administration, expenses were approximately $16 million compared to roughly $17 million in Q1 of 2024. Looking at earnings, we are reporting a net loss of roughly $46 million for the quarter compared to a loss of around $41 million in the same quarter last year. In terms of earnings per share, this result works out to a loss of $0.15 per share on a basic and diluted basis. Looking at cash flows, operating activities for Q1 of 2025 used approximately $12 million in cash and equivalents. Excluding investments in marketable securities, investment activities amounted to a net $17 million, mostly in property, plant, and equipment driven by our ongoing work to establish CMC and GMP manufacturing capabilities.

The investments in PP&E were partially offset by government contributions. And as a part of our treasury strategy, we have nearly $450 million invested in short-term marketable securities. Our investment activities for the quarter included approximately $25 million net decrease in these holdings. Altogether, we finished the quarter with over $630 million of total cash, cash equivalents, and marketable securities. 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 million in cash and equivalents and the unused portion of our secured government funding, we have approximately $810 million 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 2025. 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 3 years of increasing pipeline investments. And with that, we’ll be happy to take questions.

Q&A Session

Operator: Thank you. We will now begin the Q&A portion of the call. [Operator Instructions] Our first question comes from Brendan Smith with TD Securities. You may now proceed.

Jacqueline Kisa: Hey, this is Jacque on for Brendan. Congrats on the quarter, and thank you for taking my question. Maybe just a quick one on 635, what do you expect this asset needs to see in terms of Phase 1 data and any follow-up data to really capture that competitive edge given the head start that peers have going beyond just that it’s more of a nicer dose in preferred kind of type of medicine?

Carl Hansen: Sure. I’m happy to take that question. Carl here. So, obviously, there’s some recent activity in the approval of NK3R antagonists with fezolinetant, elinzanetant. That’s a terrific outcome for patients that are looking for non-hormonal treatments. 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 what we need to see in the Phase 1 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 population of participants.

So, one of the really attractive things about this program is that by midpoint next year, we should have data that tells us a lot about the success of the program in the science. And with that, we’d be in a position to double down and to invest further. From a differentiation perspective, which was related to, or part of your question, really it’s two things. The first is we do believe that an antibody that is specific to NK3R can have a cleaner safety profile, which is something that we believe is highly valued and differentiated. And perhaps even more in differentiation is the dosing. As mentioned in my prepared remarks, 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.

And for women that have experience with auto injectors, that number goes up to about 70%. With the growing use of auto injectors, particularly in the GLP-1 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 people that have busy lives would prefer to have something that is – something you do once a month and that you don’t have to worry about it after that. If we are successful, and of course, we’re just at the very beginning of this, so 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: Yeah, that’s very helpful. Thank you. And then maybe one, just a quick one, what should we expect to see from the upcoming 575 preclinical data tomorrow presented at the medical meeting?

Carl Hansen: Sure. Yeah. So we are presenting at SID, as I mentioned. The preclinical data will include some 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 ABCL575 is that we believe it will be differentiated in having a superior dosing regimen and we’re aiming for having at least 3 months, if not 6 months, dosing and are optimistic that you’ll be pleased with the data when you see it.

Jacqueline Kisa: Great. Thank you so much.

Operator: Thank you. Our next question comes from Andrea Newkirk with Goldman Sachs. You may now proceed.

Unidentified Analyst: Hi all, this is Solani [ph] on for Andrea. Thanks for taking the questions and congrats on the progress. Just another quick one on 635, given the risk you had mentioned facing the programmer and translatability of the NK3R engagement from the preclinical studies of humans, is there a precedent you could point to that gives you confidence that those observations will still hold in the clinical setting?

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

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 non-human primate to humans.

Unidentified Analyst: Okay. Understood. Thank you. And then just one more if I may. With both 575 and 635 now advancing into the clinic, how are you thinking about the next development candidates? And is there any line of sight of the sign as to what targets or indications might be selected or of interest?

Carl Hansen: Sure, I’ll take that one again. Yeah, so we are building 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 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 undue risk or require a huge amount of time and money to get those early answers. 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.

A 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 quite excited about that. Typically, we will not be discussing targets or indications until a program them has moved at least to development candidate. And once it is a development candidate, we will disclose the indication of 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 575, or we will hold it closer to our chest and disclose it – closer to CTA filing as we have done with NK3R.

Unidentified Analyst: Makes sense. Thank you.

Operator: Thank you. Our next question comes from Puneet Souda with Leerink Partners. You may now proceed.

Puneet Souda: My first one had to do with the 575 asset. So, during the quarter, we saw some updates from rocatinlimab as well as amlitelimab in asthma. I was wondering if you had any comments on how those readouts inform your updated view of the opportunities for the particular asset.

Carl Hansen: Yes, Carl here. I’m happy to take that one. Thanks for the question, Puneet. So, first of all, our investment thesis in 575 is reinforced by the hypothesis that the OX40-Ligand class is going to be a huge class, important not just in atopic dermatitis, which is obviously a huge market, but also will find applications across other indications. Over the last quarter, I think there’s been several points that confirm and reinforce that hypothesis. So, there is the Sanofi trial in asthma, and while they did not readout on the top-line, there was a subset of patients for which they got 70% 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 therapeutic option in asthma. And of course, Sanofi has put their money where their mouth is, they are advancing that into Phase 3. So, we see that as a very positive outcome. In addition to that, there was a readout for another OX40, OX40-Ligand molecule imaging 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. So, that is another example of OX40-Ligand being important in HS. And also reinforces a second pillar of our investment thesis, which is that OX40-Ligand is a particularly good pathway, or OX40, OX40-Ligand is a particularly good pathway for combination therapy.

You asked also about rocatinlimab. They’ve released additional data. I mean, I would say that the data is disappointing compared to what has been seen with amlitelimab. 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 rocatinlimab is, of course, a depleting antibody, where we have an Fc effector null, which will not deplete cells. So, all of that we view as being very positive and a tailwind for the program. In our shop, we’re currently focused on getting the early Phase 1 data. The most important part of that is going to be demonstrating the long extended PK and then a lot of the big catalysts are going to come from outside AbCellera and examples of the OX40, OX40-Ligand class working in other indications or working in combination are things that we believe add value to that program and make it more attractive going forward.

So, we’re keeping an eye on that just like you are.

Puneet Souda: Okay. And then I have one that’s 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 elementary discussion when you’re thinking about spinning off assets to potential partners.

Andrew Booth: 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: Got it. Thank you.

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

Malcolm Hoffman: Hi, I’m Malcolm Hoffman on for Evan Seigerman from BMO. You called up for NovaRock molecules in a clinic that have been paused. Can you provide some more context with 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 AbCellera based in Canada, is there any consideration for potentially producing U.S.-based manufacturing redundancies to kind of address that potential risk in the future? Thank you.

Carl Hansen: Yeah. Sure. I’m happy to take that one with regard to the NovaRock molecules, I 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 environment for them to complete fundraising in order to continue those trials, 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 have built this manufacturing facility in order to support us in our Phase 1, Phase 2 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, but 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: Appreciate it. Thanks, guys.

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

Srikripa Devarakonda: 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 635 that have already been done that can help you optimize your trials. And also, if I’m not mistaken, as a target has had, NK3R 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.

Carl Hansen: Carl here, I’ll take that. I’m actually not aware of the development of NK3R in neurological indications. I think there is some precedent for NK1R, which is the second target that is hit by elinzanetant. Beyond that, I don’t think I’d be able to comment. 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 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 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, 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 table as soon as possible.

So, we are looking in this first trial, not just to get a look at safety, which we believe 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 1 trial.

Srikripa Devarakonda: Great. Thank you so much.

Operator: Thank you. Our next question comes from Stephen Willey with Stifel. You may now proceed.

Unidentified Analyst: Hey, thanks for taking our question. This is Josh [ph] on for Steve. Quick one on 635. In terms of the development plan, do you think you, and I know you 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 their preliminary PK/PD and safety analyses? And 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 census to the target engagement here? And then I just have a follow-up.

Carl Hansen: Sure. Yeah. So, the short answer is in the early part of the trial we will be enrolling healthy volunteers. And connecting that with your second question, we expect to enroll both male and female healthy volunteers. And the most reliable biomarker of NK3R engagement would be testosterone levels. So that’s probably one of the early readouts that we get, which gives you some strong evidence of target engagement. But, of course, that’s not conclusive until you can show that that also translates into efficacy.

Unidentified Analyst: Great. Thank you. And then just my follow-up was on the PSMAxCD3 T-cell engager presentation you guys made at AACR. Could you just maybe tell us about – and I know it’s early, but is there anything you 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 what’s the timeline for maybe nominating a development candidate, and is there kind of an appetite for out-licensing with BD, or is this something that you maybe want to develop internally?

Carl Hansen: Yeah, I’ll start with the question about format. And, honestly, that is the multi-billion-dollar question that everyone across the industry is trying to answer. At AACR, as in previous years, 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. 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 tumor or for every target. And many pharma companies and the big players who have committed to the space, 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 the tools, the workflows, the assays, to start to systematically investigate which targets, which formats, which modalities, perhaps even combinations with co-stimulation are going to be needed to get efficacy and tolerable safety in the clinic. And 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. So, when we start to get 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 some really promising results with some of the internal programs.

You asked that 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 said in my prepared remarks, we see this as both a platform for building our pipeline as well as for partnering, and we make those decisions based on the opportunity and the framework that I described in response to the previous question, so TBD there. But, we are increasingly excited about the TCE 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 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.

Unidentified 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.

Carl Hansen: 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.