FTSE 100: Index falls as earnings results weigh; pound below $1.33, Bodycote soars
On Monday, 09 June 2025, Celera (NASDAQ:ABCL) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, outlining its strategic shift from a platform company to a clinical-stage biotech. The discussion highlighted Celera’s robust financial position and promising pipeline, while also addressing challenges in differentiating its lead molecules, ABCL635 and ABCL575, in competitive markets.
Key Takeaways
- Celera is transitioning to a clinical-stage biotech with two lead molecules entering trials in Q3.
- The company has $800 million in liquidity, supporting its extensive pipeline development.
- ABCL635 targets menopausal hot flashes, aiming for a safer alternative to current treatments.
- ABCL575, targeting atopic dermatitis, seeks differentiation through longer dosing intervals.
- Initial data readouts for both molecules are anticipated in the first half of 2026.
Financial Results
- Celera maintains approximately $800 million in liquidity, positioning it to advance its pipeline.
- The financial strategy supports over 20 development programs, with a focus on challenging targets.
Operational Updates
- Pipeline Development:
- ABCL635 and ABCL575 have received regulatory clearance to begin clinical trials in Q3.
- Celera plans to nominate around 2 INDs per year for IND enabling studies.
- Manufacturing:
- The GMP facility is expected to be operational by the end of the year, enhancing production capabilities.
- Partnerships:
- Active discussions are underway for partnerships, particularly for ABCL575, with a focus on multi-specific combinations.
Future Outlook
- ABCL635 is expected to advance to Phase 2 trials, assuming positive Phase 1 results.
- Celera is seeking a well-funded partner to further develop ABCL575, exploring multiple indications.
Q&A Highlights
- VMS Market Opportunity:
- The NK3R-targeting drugs market in VMS is estimated at over $2 billion annually.
- Celera aims to address the unmet needs of 1.2 million patients contraindicated for MHT.
- ABCL575 Positioning:
- Potentially positioned as a treatment option for atopic dermatitis patients who discontinue Dupixent.
For a detailed understanding, readers are encouraged to refer to the full transcript below.
Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Well, thanks, everyone, for joining us. I’m Andrea Newkirk, a biotech analyst at Goldman Sachs, and I’m really pleased to be joined by Andrew Booth, CFO of Celera. Andrew, thanks so much.
Andrew Booth, CFO, Celera: Thanks, Andrea, for having us.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Great. So maybe we can start big picture here. Over the last few weeks, two of your internally developed agents received authorization to enter the clinic. This has transitioned you from a platform company to now a clinic almost a clinical stage biotech. What in your view does this transition mean for Absella’s future?
Andrew Booth, CFO, Celera: Yes. Thanks for the question and the regular disclaimer about forward looking statements for the talk. I think that this transition really symbolizes, you know, we’ve moved from spending ten plus years building out our capabilities and now from building that company to now building a pipeline, now going from building the capabilities for best in world antibody discovery to now building a pipeline using those capabilities. And we have miraculously arrived here with still about $800,000,000 in liquidity. And while we still have some ongoing partnerships with some of our typical strategic partners, We’re really focusing our efforts on building that pipeline, starting with our first two molecules, ABCL635 and ABCL575, which this month have both received the no objection letter and will be entering into clinical trials in the third quarter.
We have a big pipeline of development projects behind that, about 20 plus programs, over half of which are in this difficult target space, which we think we can uniquely address with our capabilities of the complex membrane protein targets, GPCR, I in general.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Awesome. Nick, based off of the structure of your company, does that position you to stand out relative to your peers?
Andrew Booth, CFO, Celera: I think especially, you know, when when we’re building that pipeline, we’re we’ve developed a framework where in order to choose these targets, and we make we make sure we’ve developed that framework that really plays to our strengths of, you know, best in world antibody discovery. This framework, first of all, we have to like the science. We’re normally looking for targets where the science has been validated and the biological pathways have been validated. Also that we’re looking for this large commercial opportunity from an unmet medical need. And then looking for differentiation and this is where we think the antibody therapeutic can really help us stand out that differentiation.
And we can talk about that with relation to six thirty five and five seventy five in the talk here. And then importantly, places where these these indications or these targets have a very clear development path. So somewhere where for not a lot of, capital, we can get, you know, hopefully, this positive data that validates, the pathway and validates the target, in early phase clinical trials. And we’ll talk about that a little bit more when we dive into six thirty five.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Awesome. Well, that’s a perfect segue. Six thirty five, you recently just disclosed the target, the indication for this. Maybe walk us through that decision and how you what makes this this particular target and this particular indication so attractive?
Andrew Booth, CFO, Celera: Yeah. So that’s a so six three five is being targeted for, you know, VMS. So menopausal for patients suffering through menopause and specifically hot flashes related to VMS. So this is a place where the science, you know, going through our framework where the science is well validated. It’s the path is being led here for the target of MK three r through a neurokinin three receptor.
And there are a couple of small molecules that are that have validated this pathway and that are recently recently either approved or pending pending approval and where we believe that the that that pathway is is well validated. And again, it is NKTR is a GPCR target involved in the endocrine hemostasis and thermoregulation. And that primary scientific risk has been identified and and the primary sorry. The primary risk that we have is just ensuring that we get target engagement against that NKTR pathway. I’ll talk about that in a second.
Of course, the commercial opportunity here is very large. Many women, it’s a large and unmet medical need. About thirty percent of women experience moderate to severe VMS, and we think that their opportunity there for the n k three r class is, you know, well over $2,000,000,000 in annual sales. The differentiation is there with an antibody against NKTR, specifically because of some of the some of the issues, toxicity or safety issues related to the small molecules, and also an opportunity for a monthly dosing versus a daily oral. We believe that that will have an advantage advantage in treating BMS.
And the development path here is excellent. You know, there are biomarkers that are available to assess the target engagement, which we will get a readout of in phase one, and that will be an opportunity for us to get both safety and efficacy data in we would anticipate the first half of twenty twenty six. So that’s you know that the six three five molecule just kind of assessing it in the light of our framework is explains you know, why we chose that target and why we’re excited about that opportunity.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And maybe if you could speak a little bit more about what you have seen preclinically from this asset that underlies your conviction in the potential.
Andrew Booth, CFO, Celera: Yeah. Maybe I’ll just talk about the scientific pathway here and and again why why we’re excited about the science. So NKTR is a protein expressed on candy neurons within the hypothalamus, And these candy neurons play a role in regulate regulating endocrine reproductive function that impacts thermal regulatory response, via an independent neuronal pathway. And that includes, connections into the preoptic nucleus in the brain. So in postmenopausal women, the decrease of estrogen levels disrupts the balance of activity in these neurons and specifically it leads to the overexpression and overactive signaling of NK three r.
This over activation of the candy neurons then stimulates the thermal regulation neurons ultimately resulting in hot flashes. So clinically, blocking NK three r with small molecules has shown to reduce both the frequency and the severity of VMS. And in very importantly, and this is we’ll talk about this in the to answer your question about the preclinical data that we have, the infundibular nucleus where the Kandi neurons reside responds to soluble fractures in the blood. And so there’s therefore outside one of the few areas of the brain that is outside the blood brain barrier. And because this because of this, we believe that ABCL six three five should be able to engage NKTR on these candy neurons.
And that is our preclinical studies have validated that hypothesis in vivo and it is that is the major scientific risk that we hope to that we hope to get an answer on in our phase one studies. It really is this is this ability to engage the target, and we should have that data in the way our phase one study is designed in the first half of twenty twenty six.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe to that point, how translatable are NHP models in this indication? I guess, like, maybe why is there so much risk there?
Andrew Booth, CFO, Celera: Well, as I mentioned, where the Kandi neurons are located, it’s not really well well known or well appreciated that you can hit this part of the brain and the hypothalamus with an antibody. That’s it’s a GPCR target, so that plays to our strengths of being able to find potent antibodies against GPCR targets. And really, while it there’s every indication that this biology will translate from NHP studies into into human studies, that ability to hit that part of the brain with an antibody, really, you know, anything can happen in drug development as everybody knows. And really, while we have every expectation that that will work, you really don’t know until you try it. But we will get the we will get a good response or a good indication for both biomarkers as well as being able to test menopausal women in the study, in the phase one study who will be participating.
So that is that is both the both of those are are reasons why, you know, the way we’ve designed that trial for phase one is very important, and we should have a very good, indication again in the first half of next year, on how effective we are. And of course, we expect a very strong safety profile being an antibody. And the big question is what kind of efficacy can we get and how how how strong is that target engagement, in terms of delivering the signal to ultimately reduce the frequency and severity of the menopausal hot flashes.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe if there is such a risk or an outstanding question regarding the target engagement and being able to hit that with an antibody, why is this modality the one the correct one, right, especially if there are oral small molecules that are going after going after this indication?
Andrew Booth, CFO, Celera: Yeah. That is a great question. So we see Veoza or Feza Limitant. It’s been approved by Astellas, and it is a small molecule also targeting the NKTR pathway, but has some safety concerns. So it has liver toxicity issues and also has a boxed warning associated with it.
The other small molecule drug that’s in the in expecting approval, you know, is by Bayer, elenzanatant, and it targets both NKTR and NKTR and is known to have some additional effects in regarding somnolence or sleepiness and drowsiness. So the reason we believe an antibody will be quite effective here is that we are not expecting to have either of those safety or safety concerns. Of course, are known to be well tolerated and are not processed in the liver, so we do not expect to have the toxicity issues. And because it’s specific to NKTR, we also are not expecting to have the the the other the additional feature of drowsiness or somnolence. And so that’s one reason why we those are the reasons why we’re particularly excited about about the antibody approach to this problem, from the from the from the biology.
Then from the administration point of view, we actually have reason to believe that, people would prefer, women would prefer a once monthly injectable, subcutaneous injection versus a daily oral. And so we went out and surveyed a number of menopausal women, and asked if if safety and efficacy were, equivalent to the daily oral, what how many would prefer an injectable versus a daily oral? And more than fifty percent of women preferred injectables. And actually, those that had injectable experience or experience with needles, actually over seventy five percent of women with experience with injectables preferred, the idea of a monthly injectable versus a daily oral. And that was assuming equivalence in both the efficacy and safety.
Of Of course, we’re expecting to have superior performance over on safety because of the reasons we discussed. And whether we have superior performance on efficacy is really gonna the the data will tell us if that is the case. So given all of that dynamic, we think that, you know, an antibody could actually be a very effective treatment and really accepted by the patient target patient population.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: What proportion of menopausal women have this, I guess, experience with injectables?
Andrew Booth, CFO, Celera: Well, that’s we don’t know that for certain, but we do know, of course, with the the success of GLP ones and the, you know, weight loss drugs that more and more people are getting some experience with injectables. And those people who have experience with injectables, I think, you know, either for weight loss or for diabetes are over the age of 40 or and so we would expect there’s to be some correlation between the between the two. But again, even without the people, you know, taking the population at large, more than fifty percent of the people who we had we had surveyed said that they would prefer just for convenience and also compliance reasons of of taking a monthly injectable over the over the oral.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And you you mentioned here 2,000,000,000 potential Great. Sales opportunity, but maybe we can you can break that down for us. Absolutely. As you think about the agents that are currently available outside of just the approved small molecules that we just spoke about, there is menopause hormone therapy.
Maybe help us understand how prevalent that usage is. Is it effective for women? Maybe just help us understand that dynamic.
Andrew Booth, CFO, Celera: Yeah. So maybe taking a step back. First of all, there are about forty million women in The United States who are of menopausal age, and there’s actually quite a big window. Like, you can onset of menopause can happen as early as 45 and and can go, you know, well into the sixties. But only about, thirty percent of those at any one point in time are experienced moderate to severe VMS.
So that takes the population down to about twelve million. Now about fifty percent of those women seek some kind of treatment. So it’s six million at any point in time are seeking some sort of treatment. And as you mentioned, yeah, m r MHT, so menopausal hormone therapy, is, quite a good, operative alternative for those for those women. However, twenty percent of women are contraindicated for MHT.
And in addition, you know, some fifty plus percent of women have reservations about taking hormone replacement therapy, and that’s probably because of the women’s health initiative, which explain that there are some potential increased risks of coronary heart disease or stroke, breast cancer associated with taking a menopausal hormone therapy. And that has caused at least a perceived risk of of taking that and and undergoing that type of treatment. And as a result, as I mentioned, you know, there are over fifty percent of women have some hesitation. And that’s why there’s we see that being an opportunity. Even if you just look at those, as I mentioned, twelve twelve million women experiencing moderate to severe, six million looking for treatment.
Even if I just take the twenty percent that are contraindicated for, MHT, that’s still one point two million, patients, prospective patients that would be looking for some alternative to MHT, as a potential therapy, and that’s where the NKTR class of drugs, either the small molecule or the antibody could be a great alternative for them to have a choice to take some kind of treatment. That can result in a significant a very significant commercial market for for these therapeutics, and and that’s that’s kinda how we would break that opportunity down.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. So does that two the 2,000,000,000 assumes use in the 20% that’s contraindicated, so the one point
Andrew Booth, CFO, Celera: Yeah. So if you look at that one point two million women and they if we look at the small molecules, both Bayer offered by Bayer and and Astellas, they themselves, even acknowledging the presence of the others, are expect expecting at least a $2,000,000,000 opportunity. Just for rough numbers, you’ve got if there’s about a million women, the net price that’s being charged is about 5 or $6,000 a year. That’s a 5 to $6,000,000,000 opportunity. And both the Bayer CEO has indicated, they see at least a $2,000,000,000 opportunity for their for their drug.
Mhmm. And when questioned in a conference, they admitted he admitted that, that was a very conservative estimate given the size of the market and the unmet medical need and the fact that women are looking for alternatives here. Important to note that there have been trials also started for, VMS associated with cancer treatment, for women both for breast cancer and ovarian cancer, where it also similar mechanism also can experience hot flashes. And so there’s an additional indicate well, but just in the VMS associated with menopause, I think that the 2,000,000,000 opportunity, if anything, is is quite conservative.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And assuming $6.35 comes to market alongside these small molecules, how does the market segment from a biologic versus these orals? I mean, clearly, there could be a safety differentiation, the once monthly dosing convenience. Does six thirty five take that entire market share, or is there there some room?
Andrew Booth, CFO, Celera: No. I think there’s definitely room. Some people will prefer an oral. And as we mentioned, you know, just even looking at equivalents in both safety and efficacy, some people would prefer majority of people that we surveyed would prefer an injectable. And as so, if safety is superior with an injectable, I I’m sure that would be even more, but I think there’s room for alternatives, and ultimately, the patients can can take a choice.
And I think that presenting a subcutaneous injection for for targeting the m k MK3R class will do quite well in the in the market even with some extra alternatives.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Great. Maybe we can switch to five seven five where we have known your target and your indication for a little bit longer here, but just remind us the mechanistic rationale for targeting the ligands, the OX40 ligand versus some of your peers are looking at OX40.
Andrew Booth, CFO, Celera: Yeah. That’s right. Well, the OX40, OX40 ligand pathway mediates T cell expansion and survival. This is applicable TH2 and memory T cell pathways. So blocking the OX40 ligand rather than the OX40 receptor is believed to have potential safety advantages.
Really, ox 40 ligand expression is limited to sites of inflammation. Its blockade is expected to preserve the t f effector T cell and memory T cells and regular T cells, potentially avoiding some of the adverse events, related with cytokine release syndrome, so fever and chills. And that’s what was experienced from the, rocotamab, trial where it was a depleting, ox 40. And that’s we believe that there’s this opportunity for differentiation in targeting the ox 40 ligand and certainly, the ox 40 ligand, the leading molecule here is offered by Sanofi, amlutilumab, and it did not experience the same. So we have reason to believe that our ox forty will have a similar ox forty ligand will have a similar effect.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And you’re you’re exploring five seventy five in atopic derm, but to your point Sanofi is also looking at a number of these different indications here. Remind us the success behind choosing atopic dermatitis as your first indication. Do you have plans or interest in looking, you know, essentially anywhere Sanofi goes, would you follow?
Andrew Booth, CFO, Celera: Yeah. I’d say that there’s, you know, there’s actually you’ll remember, but for the benefit of others, you’ll remember the the history of how we got into this molecule. So it was originally a partnership and a co development partnership we had with a company called EQRx. EQRx eventually sold to Revolution Medicines, and this molecule reverted to us to advance. Around that time, Sanofi had some great data from their, their ox 40 ligand molecule and in atopic dermatitis.
And atopic dermatitis is a giant, unmet medical need. Of course, there’s some great, drugs. Probably the the most notable is Dupixent, which targets IL four to to treat to treat atopic dermatitis, and it’s still an $8,000,000,000 drug. So a very successful drug. But many people, discontinue, DUPIXENT, and we see the atopic dermatitis very similar to like psoriasis actually, how the psoriasis market was large enough and there’s, for many entrant entrants to come in and and have blockbuster drugs.
So we see with atopic dermatitis something similar, but also because of where ox forty ligand is in this inflammatory pathway, the opportunity to address some of these other indications. And others have also seen this. So there’s others that are coming out with oxford a ligand, also some combination therapies recognizing a larger unmet medical need here in inflammation. And I think that there are, opportunities for ourselves. However, it’s very easy to do the phase one in looking at the indication in atopic dermatitis.
We’re really in our phase one. We’re looking for safety, tolerability, and the PK, and that’s the primary data that we’re gonna get out of our phase one. And then absolutely, there are opportunities either alone as a monotherapy therapy or in combination as a bispecific, for example, as some others have taken, to treat a number of these different, indications. Sanofi, as you, as you well know, is looking at asthma as well as a number of others, and are pursuing their and continuing to pursue their asthma trial, because of this giant unmet medical need and where OX40 ligand, the OX40 interaction plays in this pathway. It’s quite upstream, and it’s expected to have potentially, you know, very useful biology for many of these indications.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: You mentioned DUVI here. Guess how are you thinking about five seven five fitting into the treatment paradigm? Would this be a post DUPI type setting? Could this potentially compete with where DUPI is being used?
Andrew Booth, CFO, Celera: Yeah. Absolutely. So as I mentioned, DUPIXENT is it’s a great drug, generates about 8,000,000,000 in sales, shows good efficacy and a very reasonable safety profile. But despite the success, there’s still a high unmet medical need only over a little over half the patients achieve this kind of response rate. And and a minority of patients achieve, like, clear skin and the complete resolution of their their symptoms.
There are others, IL thirteen blockers as well, as well as IL four. And what we would expect is, you know, for those patients that didn’t respond to either the IL-four, IL-thirteen blockers, that they’d be looking for a different mechanism of action as a second even in second line. And that’s where I think the OX40 ligand class could really play a a major role. And that in itself could be a multibillion dollar market. And certainly, I think even just as second line, you’d be looking for something that had a different mechanism of action rather than going to another aisle four, aisle 13 blocker.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: And then just on that point, remind us how five seventy five is differentiated from Sanofi’s ox 40 ligand?
Andrew Booth, CFO, Celera: Yeah. I think well, we recently published some preclinical data, which I know many were waiting for at the Society for Investigational Dermatology. So there’s a great data package there about the, about the preclinical experiments that we’ve run for five seven five. I think the most notable, point of differentiation would be in half life. So the half life of, five seven five is over sixty days, whereas the half life for Sanofi’s acid is under 25, so between twenty and twenty five days.
So that offers an opportunity for less frequent dosing. Even as it stands, the amlutilimab could get monthly or maybe even quarterly dosing. I think the data would show that they’ll get at least monthly dosing. And, of course, that would also be superior to to Dupixent’s dosing scheme. And that would open up an opportunity that we think if emlotilimab is successful in getting a thirty month thirty day dosing or monthly dosing that we should get quarterly given the difference in half life, maybe even semiannually.
It just really depends on we’re waiting to see that data just like everybody. But I think that’s the opportunity we would have for differentiation.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: And if they’re able to show quarterly dosing, does that decrease the value proposition in any way for for five seven five?
Andrew Booth, CFO, Celera: That depends on if they are showing quarterly dosing, does that mean there’s an opportunity for semiannually or even annual dosing with such a you know, with the data which show that there’s significantly larger half life? That could be an opportunity. How important is that? That that remains to be seen. Like, once you have quarterly dosing, is that gonna be good enough?
And then then I think there’s the opportunity, you know, for with our five seven five molecule, which we believe is a very good molecule, maybe it has also opportunity in in combination therapy bispecifics with some of these other inflammatory targets. That would be an opportunity.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Okay. What is gating to initiating these phase one trials right now?
Andrew Booth, CFO, Celera: Yeah. As I mentioned earlier in our discussion, you know, we received the, no objection letter from Health Canada. So we’re we’re running these trials in Canada. We have a CTA, filing that’s been accepted. You may remember we received some funding from the government of Canada to to run these trials in Canada.
So we actually have a low cost of capital position on on executing on these phase ones. With these no objection letters in hand, we are activating sites and would expect to start dosing in the third quarter, so imminently, really. And we would expect in our next earning call to give you an update on on how is that going. And yeah. So we’re really excited.
That’s kind of the next major milestone in Ebsalara’s trajectory is to start dosing our first patients.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: And what can we expect from that first data disclosure for for June as well as May?
Andrew Booth, CFO, Celera: Yeah. As I mentioned, we both we’d expect both of the the the first data to come out in the first half of twenty twenty six. For ’6 ’3 ’5, we’re expecting, you know, safety, tolerability as well as the biomarker data that we mentioned that confirms the target engagement as well as having some, VMS, patients in the trial. So maybe some early signs also of efficacy. And in six in five seven five, it’s really, the dosing and PK, so safety tolerability and PK that we’re expecting.
Again, a well established, clinical trial design from the amatilumab so that we’re able to just be able to compare that data head to head.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And then just quickly on June, you are also including male healthy volunteers. Maybe help us understand the rationale behind that, and and what can you expect to learn from
Andrew Booth, CFO, Celera: Yeah. So the male volunteers are there because a very similar pathway where the biomarker is reduction in testosterone levels. So you could with dosing males and measuring testosterone, we’re able to see, you know, the effects of target engagement, and that’s probably the clearest biomarker data that we’ll have for, you know, confirming target engagement and the degree of target engagement in the in the healthy males.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And so you’ve committed to running these Phase I trials, but there will be a divergence as you look to potential further clinical development. Maybe just what is the latest as you think about May versus 635? Which program would you be willing to move forward on your own? Which one would you look to partner?
Andrew Booth, CFO, Celera: Yeah. I think well, certainly, the easy answer there is with 635. We absolutely are looking forward to the to a phase two. So we are getting the plans ready assuming success, and we’ll follow the data. If the data indicates that we have strong target engagement and even that early efficacy data, which we’d be excited to see, that’ll help us with our conviction and confidence in in moving forward with the phase two.
With five seven five, as you know, it’s been known for some time what that molecule is. We’ve had many active BD discussions. I think it’s our current belief that molecule might be better in the hands of a a partner or a sponsor that can really look broadly across different indications for a a phase two. And so we’ve had a number of partnering discussions already looking at that. However, we’ve always had the conviction to be able to do the phase one partly because of this government funding and because of how straightforward this trial is.
And I think any partner will also love to see that, safety and PK data from May through the phase one. But that’s one where probably the the likely path would be to hand that off to another partner in order to advance it through a phase two.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. Is I guess, is phase two the right time to find a pre phase two, is that the right time to find a partner? Or is there
Andrew Booth, CFO, Celera: For May.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: For May? Or is there value in potentially running a small phase two, get that validation, and then
Andrew Booth, CFO, Celera: Well, it’s like every answer in program answer, it’s like it depends. You know, it depends on what the what who the partner is that we might be able to find. If we can find the right partner I think what’s most important with five seven five, because as we’ve discussed, there are multiple here is really streamlined clinical trial design and speed. And for that reason, it’s good to try and find out who that who is going to be bringing phase two forward early, whether that’s ourselves in doing a phase two two a or something in order to keep that program moving because of the competitive environment. Yeah.
Especially given this given the dosing profile, it could be very attractive. And we don’t wanna be slowing that down by having protracted partnership discussions. So either we will have the conviction to keep moving and advancing that molecule through trials, or we found a partner who has that conviction and we’re happy with the transaction that we could do in order to keep that molecule moving forward.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: And we’ve talked about this in the past. As you think about potential partners and maybe what they can bring to the table, their capabilities, how are you thinking about the characteristics of that partner for May? Because this could really be a pipeline and a product. So who is the ideal partner for you for May?
Andrew Booth, CFO, Celera: That is a great question. Because of that feature that you just mentioned there, this could potentially be a pipeline in a product and the the broad implications of the ox 40 ligand pathway and all these different cases of inflammation. So it would be a well funded partner that could advance ideally multiple indications and maybe including maybe some of these multi specifics. So if there’s other targets that would be in a great alter or a great option in combination with the best in class OX40 ligand. Someone, a partner with a, who who had the conviction and had the capital to pursue that that that kind of broad based phase two trial would be a great partner for this asset because I I I think we also are encouraged by encouraged by the amount of attention that this pathway is getting from a variety of players, and we do believe we have a best in class molecule with our five seven five molecule against oxfordal ligand.
So and the preclinical data that we presented at, the Society of Investigational Dermatology, think, would back that up and has, you know, renewed the interest in this in this molecule for partnering, as well as the fact that we are moving it forward into phase one, you know, kind of at quite a good pace. So I think the partner that we’re looking for is is a sponsor who could really invest the resources to do the appropriate phase two and and and ultimately ultimate clinical trials for this potential pipeline in a product pipeline and molecule product. Maybe
Andrea Newkirk, Biotech Analyst, Goldman Sachs: in the last couple minutes we have here, any updates that you have on your partner initiated programs, the sort of your legacy business, that component?
Andrew Booth, CFO, Celera: Yes. Well, we’ve in the first half of this year, we announced a good partnership with AbbVie around the T cell engager platform. We didn’t talk about T cell engagers today, but maybe for another time. That’s progressing well. We still have our other partnerships that are progressing well.
Just more fulsome response around the rest of the business in addition because we spend a lot of time on six thirty five and five seventy five, and of course, that’s kind of new for us since we spoke last. But we continue our investment in our GMP facility. Actually, that is going to be up and running at the end of this year. And it’s just in time to start receiving the next molecules that we’re going to get to our IND enabling studies. As I mentioned, we have some 20 plus programs we’ve started, over half of what approximately half of which are in the difficult target space that have gone through our framework of where we believe that there are good opportunities for us to pursue.
We’d expect the next the next candidates to be on this pace for roughly two INDs per year. We would expect the next candidates moving into IND enabling studies to happen during the rest of this fiscal year, and and we’ll announce those as they as they come. Probably with similar level of disclosure of six three five, so it might be a little frustrating because it was quite cryptic until we entered into the clinic. But that’s what we can expect. And in addition, the partnership business, I think, will continue with these strategic partners that we’ve established, including some interest in taking the early discovery through to the CMC GMP for those partnerships and certainly for our own programs that are advancing to that facility for later this year and the beginning of next year where where we’ll be able to manufacture the materials in our pilot plant for all of the preclinical studies as well as the GMP runs supporting our our clinical trials.
Andrea Newkirk, Biotech Analyst, Goldman Sachs: Great. Well, with that, Andrew, thank you so much. Thanks, everyone, for joining us.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.