Innate Pharma SA (IPHA) September 2026 Conference Transcript

good afternoon and thanks for joining us to have a conversation with jonathan dickinson ceo of innate pharma and stephanie coronan vp investor relations innate pharma is a global clinical stage biotech company developing immunotherapies for cancer patients leveraging its expertise in antibody engineering and innovative target identification So, INIT's proprietary pipeline is now centered on antibody drug conjugates led by IPH4502, a differentiated Nectin-4, Exatec, and ADC, currently in Phase I in solid tumors, and where dose escalation enrollment has been completed in July, and preliminary data from the 76 patients are expected by the year-end. And in parallel, INIT is also advancing two partner late-stage assets, lacutamab, recently licensed to SOBI for T-cell lymphoma, and with INIT running the Telomac 3, confirmatory phase 3, in support for planned accelerated approval filing for cesarean syndrome. And the last but not least, monolizumab, which has been partnered with AstraZeneca. AstraZeneca is currently running a Pacific 9 clinical trial with primary endpoint expected, you know, in non—I mean, unresectable non-small cell lung cancer expected by ERN. And so to discuss all these assets, I welcome Jonathan and Stephanie to this fireside chat. So, Jonathan, briefly, you know, for folks who are new to innate, you know, how would you frame the company's strategies today, now that some of the proprietary pipeline is, you know, quite centered in the ADC space, and with other two assets partnered away?

Yeah, so I think our strategy doesn't really change, versus where we were, I guess, roughly a year ago. So about a year ago, we changed our strategy and we really focused on our three core assets. We actually have eight assets in the clinic, but we really wanted to focus on the three assets that we believe have the best chance to win. It doesn't mean that the other assets are not moving forward. They're in academic collaborations or they're moving forward in, I would say, a low expenditure sort of mode. So we're putting all of our time and attention into those three core assets, and we've had a number of strategic priorities for those assets. The first was around lacutumab, which was basically moving forward and taking it into a confirmatory phase three study under the breakthrough therapy designation from FDA and the accelerated approval pathway that we'd established. But we needed to raise capital to be able to do that. And we were looking at a number of ways of actually doing that. We finally concluded that the best way forward was with a partnership. And we managed to sign a partnership with Sobe in early August. What I really want to emphasize is that doesn't mean we're handing the product completely over to Sobe. As part of the partnership, we continue to execute the phase three program, the Telemag three program, and we will take forward the accelerated approval. So we'll be filing the BLA. So really, Lacutamab is still a very core part of what we're doing moving forward and taking it through to the next steps, which are obviously really important. And then we continue to focus on IPH 4502, on acting for ADC. We have a pivotal data readout coming later this year, so that remains a key focus for the company. And then we have the partnership with AstraZeneca for monoluzumab, which is targeting NKG2A in combination with DERVA. And the primary completion date for the phase three pivotal study is actually September, so end of September, so just in a couple of weeks' time. and we expect the data readout from the primary endpoint before the end of the year. So it's a really busy period of time over the next few months as we continue to execute against those three priority programs that we established. At the same time we established that strategy, we also communicated that we would focus our preclinical activities on coming up with the next wave of ADCs. So we're making good progress along that line, and we're really focusing on some, I would say, interesting and novel aspects to make sure that we bring some potentially best and first-in-class ADCs to the table out of our preclinical organization.

Fantastic. So, Stephanie, you spent quite a bit of this year talking to investors, obviously with some of the fundraising conversations that you have had. So in general, what do you think people are not still valuing in the story? And where do you think people should start paying attention now that at least the funding part of it is not a question anymore?

Yeah, yeah, yeah. Thank you, R.K. So, indeed, I think that some parts of the innate theory are still underappreciated. One good example of this was lacutamab. We have spent the past 12 months with Jonathan and Yanis trying to raise awareness about what is the CTCL market. And I think that with the SOBI partnership and the economic of the deal, we have now a tangible external validation of the potential of lacutamab, which is great. And now I think that eyes are focused on MONA, of course, but also IPH4502, and the question we received the most is about the positioning of this asset in the current Nectin 4 ADC landscape and more broadly in the increasingly competitive ADC landscape. And what we refer to is about the evidence that we already have. We know that PADSAVE has validated Nectin-4 as a target in urethelial cancer, but there remain a high unmet medical need in the post-EV setting. And Lily has presented two clinical data sets in the post-EV setting, validated in a way the potential of a topo-1 Nectin-4 ADC in this setting. However, this also reminded us that something that we all know, that in ADC design matters because one of the assets from Lily has been discontinued because of tolerability challenge and the other one required some pharmacogenomic testing. And so I think that now the question is really not about is Nectin 4 topo 1 ADC a valid approach, but is there a Nectin 4 topo 1 ADC out there that can meet the expectation of a manageable safety profile and a meaningful clinical activity. And this is exactly what we are trying to achieve with IPH 45.0.

Very good. So let's start off with the recent news, which is a SOBI partnership, right? So as you stated, you know, you're not really given, I mean, you're not given the development part of the placutumab. You're still running the clinical trial, you know, can you speak a little bit more about that arrangement into why you feel that kudumab is better to be developed in your hands, and do you think you would have gotten better in terms of economics if you had given an outright sale of the asset itself?

Yeah, it's an interesting question. I mean, we spent a lot of time really evaluating which direction to go in. Is this something we should try and do ourselves? Is this something we should partner? And I think it really all depended on the deal that was on the table. And I think we'd always communicated this. If we got the right deal, then partnering will clearly be the preferential way forward. In the absence of the right deal, we were prepared to try and take this forward ourselves. and we thought it would be viable to be able to commercialize Lacutamab ourselves. It's a relatively small number of customers that you would need to hit in the US, probably 50 centers you would get to the majority of the patients. So it was definitely something that was viable to take forward as a small biotech company. But at the end of the day, we got a really great deal on the table with Sobe, which had really good deal economics associated with it. It provided the capital up front for us to be able to move forward with the phase three program and really start the clock on moving towards the accelerated approval. And then I think if we look at the partner we have, it's a really great partner for a lacutumab. The initial indication is cesarean syndrome. It's an ultra-rare indication. Then coming with mycosis fungoides, which is also a rare indication. So Sobi has a real speciality in rare diseases, and in particular in oncology. So I think what we're able to do here is combine the synergies of both companies. We have expertise in CTCL and allowing us to continue to take the Phase III program. That sort of builds on our skill set. And then we have Sobi who will come in. They have the infrastructure there to be able to commercialize lacutumab in the most effective way, the most quickly. So we'll be able to provide lacutumab, I would say, to patients probably more quickly and more effectively with SOBI taking that role. And if we were building an organization ourselves, so that's good for patients. But it's probably good for an aid at the end of the day in terms of the royalties that we'll achieve on sales and the milestones that we will hit under the collaboration agreement. So I think in the end, it was a pretty easy, straightforward decision to actually go with the partnership.

So, you know, the accelerated approval filing that we are talking about, you know, still rests on the Phase II Telomac data in the sensory post-mogamulizumab with, you know, 43% global ORR and 25.6-month median duration of response. So, what have your FDA interactions told you that needs to be in place, you know, to do that filing and, you know, where should Telomag3 enrollment be at that point?

So, the discussions we had with FDA under the Breakthrough Therapy designation, which is really important because it gave us really good access to FDA and we had a number of backward and forward interactions but basically the guidance we got we got from FDA was that we need to have the confirmatory study up and running it needs to be recruiting patients and we need to have established a recruitment trajectory that gives them confidence that we will go on to fully recruit the study so we believe that that means we need to have recruited some patients we had need to have a good number of the sites open so basically demonstrating that the company is committed to moving this forward and at that point we'll have a pre-submission meeting with fda and file the accelerated approval bla off the back of that so in terms of timelines we expect to have the telemax 3 study initiated in the coming weeks we expect to be able to have the first patient included in the beginning of 2027 and then we expect to submit the BLA in the second half of 2027, which with a six-month clock will read to an accelerated approval in the first half of 2028.

So can we just discuss a little bit on the highlights of the Telomac 3 study itself as it is set right now? And then when, in terms of enrollment, you know, that we are talking about, you know, that you have to set up, you have to show a certain trajectory. Is there anything hard in terms of sales with the FDA, or is it a trajectory which they decide whether it's the right one?

No, I mean, just addressing that question, I think the conversation we had with FDA is that they want to see the study up and running. I think that's the most important thing is that the study is up and running, particularly in a rare disease like cesarean where there's a very small number of patients. We've seen recently, I think with some FDA precedents, that they're being quite lenient on this in rare diseases. They're giving quite a lot of leeway. So our expectation is you have the study up and running, you've recruited a handful of patients, you have the right number of centers open that shows that you're really committed to getting the patients and it should be a relatively straightforward path at that point. In terms of the study itself, we plan to go to nearly double the number of centers that we went to in TeleMAC2. We have a lot of experience in this market having recruited the TeleMAC2 study, so we know where the patients are, we know the centers that we need to go to, and we're increasing our footprint. It will be a global study, and that gives us a lot of confidence that we'll be able to recruit the patients in a very timely way, and we'll fulfill the requirements that FDA need to see that this study is going to deliver. Okay.

So, getting into IPH4502, the nectin-4-exatecan, ADC, how differentiated is this molecule versus other Nectin-4 ADCs that are out there in the clinic?

So, I mean, we specifically designed this molecule to be differentiated, and we did that in a number of ways. The first is the epitope that we hit. We hit a non-overlapping epitope versus any of the other Nectin-4 ADCs out there. What we've been able to demonstrate pre-clinically is that that means that we combine not only the high nectin-4 expressing tumors but also the low and the moderate nectin-4 expressing tumors so that's that's one level of differentiation we think we have a better antibody basically from a binding perspective for nectin-4 then with the payload um we've switched the payload out we have a very well validated payload in exotecan and i think that's that's that's important um because we we're not encountering some of the issues like with the with the lily nectin for ADC they had this issue with metabolism through CYP2D6 where there's genetic variation with their Campto 98 payload and that led to some severe toxicity in in the low metabolizers so that creates issues for that program you need to be aware of drug drug interactions you have to exclude the low metabolizers and then if you think from a commercialization perspective that's that that that's difficult so that's important so we have exotecan it's it's a very well-known payload um and that overcomes the drug resistance issue associated with uh with mmae as a payload and that's been validated by the lily approach actually so that's that that's great and then we combine that with our proprietary linker and we know we very tightly bind the payload and that's important because if there's less recirculating payload you we see less toxicity and we see that coming through in our phase one dose finding study where we have low levels of recirculating payload and we've seen minimal hematological toxicity which would be an off-target tox and our DLT was actually an on-target tox so I think it's validating our linker approach and pulling all those three levels of differentiation together, I think we have an opportunity to thread the needle here and really come up with something that can show efficacy, that can have a really good level of safety, and not have some of the liabilities of some of the other Nectin-4 ADCs which are out there today.

So at the year-end data update that we're expecting from this molecule, what sort of data will make you comfortable that you're on the right pathway?

So, I think the key thing is the safety. Obviously, the primary endpoint of this phase one dose-finding study is safety. So, if we see good safety combined with some level of activity, I think that will give us confidence that we have a pathway to move forward with this particular product. And we'll look forward to presenting the complete data. and I think the importance will be the totality of the data set. So our phase one dose finding study, it's a basket study in a range of different tumor types. We've tried to over-recruit in certain tumor types so that we will be able to see some sort of trends in that. But it will be the totality of the data which will count particularly from an efficacy perspective and then from a safety perspective across the board.

So, you know, in terms of the ADC portfolio that you are talking about, you know, you have previously talked about, you know, looking into bispecific formats, better internalization, and also, you know, novel dual payloads. So, you know, of all these things that you're talking about, you know, which ones do you think are close to be unveiled, maybe in 2027, or are you still playing with these different formats to figure out which one gets closer to pre-IND stage?

So, I think what we're doing, we're really focusing now on trying to bring something to the table that's going to be truly innovative. There's a lot of work ongoing in the ADC space, a lot of potential molecules out there. And I think the key thing here is to come with something that's going to be truly differentiated. So we're actually following three approaches at the moment from an ADC perspective. We're looking at bispecifics to start off with. And we have, I would say, a world-class expertise in antibody engineering. So this is something that we do a really good job of. What we're trying to do is then to combine that with a couple of things. We're trying to look at very tumor-specific antigens that may be expressed at very low levels. And it's difficult then to get enough payload into the tumor cells. So what we're aiming to do is to combine those very tumor-specific antibodies with professional internalizing molecules so that we're able to ensure that with this very specific approach to a tumor, we're able to get enough of the payload into the tumor cell and to have the cell killing that's required to have an effective product. So that's one approach that we're really looking at. And then the other is dual payloads combined with the bispecifics and the other approach. And when I say dual payloads, it's not a question of combining a Topo-1 and a tubulin inhibitor. It's really coming up with novel payloads that will bring something truly differentiated to the table. So we're really working really hard in our preclinical organization now to bring the right target products through into the next steps to then be able to go into the IND enabling stage. So we're a little bit away from being able to do that. That's not something you should expect in the next couple of months. But it's something we've got some very interesting concepts that we're working on, and we're very confident that we're going to have some approaches that we'll be able to take forward next year and then potentially from that into IND enabling studies.

So one quick question on monolizumab. You know, you were talking about how the study could end in September, but the primary endpoint data is expected, you know, hopefully by the year-end. You know, what sort of data are you looking that it'll get disclosed, and, you know, how should investors view that data in relationship to the totality of the program?

So for monolizumab, I think for MONA, I mean, it's a PFS endpoint. So I think providing we're hitting a reasonable hazard ratio with a good PFS number, I think there'll be a path forward. So if we see a positive study here, this should move forward, and it should move forward into commercialization. And I think it's in AstraZeneca's interest to take forward the product. They need to protect the DERVA franchise. So this would be one way to do that. And they have a substantial amount of sales at stake here in the stage three non-respectable, non-small cell lung cancer setting. So MONA will play a very important role here if the study is positive. And based on the COAST data, which was a randomized phase two with the regimen that's being used in the Pacific 9 study, It led to a 12-month medium PFS advantage in the Mona arm versus DERVA. So we have a reasonable level of confidence that we can come close to replicating that level of efficacy that you're going to see a positive study. And I think that obviously will be transformational for the company because there's some excellent deal economics associated with a positive study. so under the original collaboration agreement there was up to 825 million on top of the 450 that we've already received there's a mixture of development regulatory milestones and commercial milestones and obviously that will be transformational for the company it will be a fantastic source of non-dilutive funding for some of the other other programs we want to take forward like our adcs and potentially 4502. So it's a really important catalyst for the company.

So just a last question, and to close the conversation. AstraZeneca's license on monolizumab is only for oncology indications. Do you see that drug in other indications, potentially, outside of oncology?

And if yes, do you see yourselves partnering it out or looking for another way of non-dilutive So I think you're referring to some very interesting data presented earlier in the year in fibrosis where there was a very strong preclinical hypothesis for taking the product into fibrosis. So I think for us, the Pacific 9 study is gating. If that study is positive, then I think fibrosis is something that we should definitely be looking at and looking at how we take that forward. As you stated, the AstraZeneca license is just for oncology, so the fibrosis indication would be proprietary for innate pharma. So I think we will be open to different approaches here. if we've got a good source of non-dilutive funding coming in from Mona through the AZ collaboration, that would afford us the opportunity to potentially do this ourselves. My guess is that if PAC-9 is positive and Mona is moving forward, that AstraZeneca would be very interested to control the entire rights for monoluzumab. So I think they could potentially be a partner that we would certainly be having discussions with and i think because fibrosis is such a a big unmet medical need that if there really is a good approach here that there could potentially be other companies so i think it could get competitive and we should be able to find a partner or take it forward ourselves so i think that's all a next step after a positive pac-9 study so fantastic great thank you very much jonathan thanks for taking time thank you okay and thanks for inviting us.