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Earnings call · FY2026 Q2
Executive readout · one minute
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Hello, everyone. Thank you for joining us and welcome to the Innate Pharma Webcast Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press start 1 to raise your hand. To withdraw your question, press start 1 again. If you have logged in via the webcast, please use the Q&A button to submit your questions. I will now hand the conference over to Stephanie Cornen, Vice President of Investor Relations and Communication at Innate Pharma. Please go ahead.
Good morning and good afternoon, everyone. Thank you for joining us for the conference call. Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectation. This statement involves risk and uncertainty that could cause actual results to differ materially. With that, I will now hand it over to Jonathan.
Thank you, Stephanie. And thank you, everybody, for joining us this morning in the US, this afternoon in Europe to discuss this morning's announcement of Innate Farmer's 30 million equity raise. This week has been a very busy and important week for innate pharma, putting in place the critical elements which allow continued advancement of the strategic agenda which we announced in September last year. As a reminder, this strategic agenda includes a number of items. First, advancing lacutumab into the confirmatory TELEMAC 3 phase 3 study in cutaneous T-cell lymphoma, which has already been green-lighted by the FDA. Study initiation allows advancement towards the BLA filing for cesaree syndrome under the FDA breakthrough therapy designation once patient recruitment is ongoing. The strategic partnership with Sobe, which was announced on Monday, allows initiation of the Telemax 3 study. As a reminder, INATE will continue to run the study based on our extensive experience and expertise in CTCL. At closing, which is subject to conditions including antitrust clearance, SOBE will pay in eight a 75 million upfront, as well as up to 40 million in near term milestones associated with the Cesare syndrome accelerated approval. There is subsequently an additional 465 million of opt-in regulatory and commercial milestones, as well as double digit tiered royalties on future lacutamab sales. Sobe will take on the full global commercialization following the accelerated approval. The Sobe partnership now allows innate to proceed at full speed with Locutumab using the proceeds of the agreement. Second on the strategic agenda is the advancement of IPH 4502. our second generation differentiated Nectin-4 targeted ADC, which has shown preclinical activity in the PADSF resistance setting, as well as in tumor models of low Nectin-4 expression. We communicated on July 21st that we have completed enrollment in the dose escalation study with 76 patients. To date, we have seen preliminary clinical activity, including in the post-PADCEF urophilial cancer setting, where there is higher medical need and no standard of care, as well as in non-small cell lung cancer and head and neck cancer. We also observed a favorable safety profile to date with limited hematological toxicity, supporting the hypothesis that our proprietary linker minimizes the release of payload into the circulation. The dose escalation results will guide the next steps for development and the data will be presented at a medical conference before year end. And the third part of our strategic agenda is the advancement of our ADC preclinical portfolio, building on the IPH45O2 linker, which has shown stability in patients already. So with the ADC preclinical portfolio, we're following three approaches. The first is a dual targeted bispecifics approach to address tumor antigen heterogeneity and expand addressable indications compared to single tumor antigen targeting. The second part of the approach is bispecific ADCs with enhanced internalization to unlock activity in tumors with low antigen expression. And the third part is using novel dual payload ADCs using complementary mechanisms of action to overcome resistance. The 30 million equity raise, which was announced this morning, allows innate to progress this strategic agenda, starting with seamless progression of IPH 4502 into next development steps based on the data from the dose escalation phase one. And then progression of our next wave of preclinical ADCs towards candidate selection and IND enabling studies. Also on our strategic agenda is next steps for monoluzumab, our NKG2A targeted antibody, which is being developed with AstraZeneca in stage three non-resectable, non-small cell lung cancer. The primary completion date for the Pacific 9 study is the end of September with data for the primary endpoint expected by year end. This is important for an eight and, if positive, represents a significant future source of value for an eight with up to 825 million of potential milestones, a 50 percent profit share for Europe and double digit royalties on sales outside of Europe, including the US market. The $30 million raised, together with the $75 million upfront payment payable upon closing of the strategic partnership with Sobe, extends our projected cash runway through Q1 2028. The focus now is on execution and delivering against our highlighted strategic priorities. Thank you for your attention and we can now open the line for questions.
We will now begin the question and answer session. If you would like to ask a question, please press Star 1 to raise your hand. To withdraw your question, press Star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. If you have logged in via the webcast, please use the Q&A button to submit your questions. Please stand by while we compile the Q&A roster. Your first question comes from the line of Dana Graybosh with Learing Partners. Your line is now open. Please go ahead.
Yeah, thanks for the question. I wonder for IPH 4502, if you can give us any more guidance on how many patients and follow-ups you'll have in the three highlighted indications. So the post, had step, bladder, head and neck, and lung. and then I have a follow-up after that.
So maybe I can take that one, Dana. So we've not given any guidance on the specific number of patients in each of the indications. What we've said is we expect to have 10 to 15 patients at the go-forward pharmacological doses in each of those indications. In terms of the amount of follow-up, as you can imagine, the last patients were recruited in the middle of July, and we will need to follow those patients and have the first scans to be able to have efficacy data on all of the patients. So that leads us to a time point later in the year, and hence the guidance that we will be presenting at a medical conference later in the year. I think most people have deduced that's not ESMO, so a subsequent medical conference.
Got it. And then we've had a lot of Exatecan ADC readouts recently with, I'd say, wildly different therapeutic indices. You have the tubulus, one that was at ASCO. You have a Lilly one at ASCO. You have a Sutro one this week. I wonder if you could speak to more about why you think there's differentiation in the therapeutic index across these ADCs and what we should expect and why we should be excited about IPH 4502?
Maybe I will let Yanis take that one. Do we have Yanis on the line? I don't think we do. So maybe I will give it my best shot and maybe Stephanie can jump in. So I think what we have communicated, Dana, is that what we've seen so far is that our linker, I think, benchmarks with the best linkers that we've seen out there. We've also been able to achieve doses which are in line with other Topo1 and Exatecan-based payload so we're at that point where um with other targets at uh the particular dose we're at we we've basically seen efficacy with those other products so i think that gives us a a good sense of where we're at i think the other thing that we found very encouraging was the lily data set with their ADC with the Camto 98 payload at ASCO in terms of the fact that it validated the approach of coming with a Topo 1-based ADC targeting Nectin-4 post-PADCEF. So we took that as a validation, of course, with the caveats of the Lilly ADC and the payload being metabolized through 2D6 and having this genetic variation and potential liability associated with that. So if we pull that together, I think we're feeling quite confident that we have a window here from a dosing perspective where IPH4502 will be effective. And I think we've mentioned we have seen responses, including in the post-PADCEF setting. And basically every one of our urophilial cancer patients that's been treated in our study has had PADCEF. And I think all but one has also received PEMBRO. So really, these patients have had the best standard of care. I think when you see any level of activity in this particular patient group, take into account where we've recruited these patients, because the phase one sites are open with five sites in the U.S. and two sites in France. So all of these patients have had the best standard of care and are progressing on therapy when they enter the study. So when we see activity, we're genuinely seeing something real here. And we continue to be excited about that. Hopefully that's answered part of your question. We have Yanis on the line now, so I don't know whether he wants to add anything to that. Yanis, you're on mute, Yanis. OK, I'm sorry about that, Dana. It looks like Yanis is unable to speak. He's actually on vacation this week, somewhere where the Internet connection is not great. And he was dialing in at the last minute. So hopefully I've addressed your question.
Thank you. Maybe Yanis can follow up when he's back from his vacation too. Thank you. I'll get back with you.
Thank you. Thank you, Dana. I think we can follow up offline maybe afterwards with Yanis.
Your next question comes from the line of Swayan Pakula Raman Kempf with HC Wang Ride. Your line is now open. Please go ahead. Please remember to meet yourself locally. Thank you.
Can you hear me?
Yes, we can hear you, RK. Okay.
Can…just trying to understand the impetus behind the raise today. Is this 30 million euros…is this going to…is this to be thought of as a bridging funding between now and the close? Or is this so that you can hazen up some of the work that you need to do on Telamag 3 from here on?
So the rationale for the raise, RK, is basically to allow us to continue to move seamlessly into the next steps for IPH 4502. What we didn't want to do is present the data later in the year and then have to go out and raise money to be able to go into the next steps. So having done this raise now, we can plan for the next steps for IPH 4502 and dependent on what the data shows us, we can go seamlessly into those next steps. This is a competitive space and I think based on where Lily's recent presentation and some of the ambiguity around their program, we think now we're probably close to the front of the pack of at least Western-based Nectin-4 ADCs. So we want to be able to continue the momentum and speed with 4502. And we also want to be able to take the next steps for our preclinical ADC portfolio. We have an exciting portfolio of preclinical ADCs, which we will reveal in due course at the appropriate time, based on the fact that we have a linker that we believe is very effective now and has proven itself in the phase one study. where we're in a good place to be able to take advantage of our antibody engineering capabilities and produce by specifics but also to look at ways of improving internalization and also to look at novel dual payloads and i don't mean combining mmae and topo one i mean some genuinely innovative approaches from a payload perspective that will bring something different to the table So the raise allows us to continue and to move those programs forward now that we have the resourcing in place to be able to take Telemax 3 into the next steps and to move forward. So this is really about making sure we can move fast on the rest of the portfolio.
Thank you for that. Quick follow-up. So, just following up on Dana's question, at what point, you know, hopefully this year, that we would get a good picture of where 4502 is in the development pathway, and what are the different indications that you would certainly go into and also reveal some of the pipeline molecules that you're talking about? You know, is this going to be happening sometime within the rest of 2026, or should we wait up to 2027?
I think for the pipeline, it will be sometime in 2027. We would start to potentially communicate on those aspects. For 4502, we'll get a better sense of the data when it's presented at the medical conference later in the year. So I think that's basically the key piece here. And the next steps will obviously be based on the data. And we've not seen the full data set yet. So we need to see that data set, and that will dictate which tumor types we go into. What we have said is that we've seen activity in urophilial cancer post-PADCEF, and we've also seen activity in head and neck cancer and non-small cell lung cancer. So I think they're likely candidates, but that, of course, has to be validated by the complete data set, which we will see later in the year.
Thanks for taking my questions, Jonathan.
Thank you, R.K.
Your next question comes in the line of Yee Tamerkeji with U.S. Bangkok BTIG. Your line is now open. Please go ahead and please remember to unmute locally.
Thank you for taking the question and congrats on the financing. One question from me. Any additional thoughts around expansion opportunities for monolizumab outside of oncology, such as IPF or other fibrosis related indications. I'm sure you saw the Science Translational Medicine article that came out a few months ago highlighting monolizumab's potential in such indications. So I was curious regarding your thoughts around going in that direction. Thanks.
Thanks, Jeet. We were, of course, very happy to see that publication. I think it's another potential avenue for monolizumab. What I would say at this moment in time, we're really focusing on the readout from pacific 9 that's our critical gating criteria here and i think if if we see a positive study for uh with pacific 9 in non-small cell lung cancer then i think that's the time to really further evaluate other potential uh opportunities and i think one thing just to remind of is that az have life have the license uh through the collaboration agreement uh for monoluzumab for oncology and any additional indications. So the fibrosis indication would be a new indication that wouldn't fall under the collaboration agreement. So I think the bottom line is we'll wait and see what Pacific 9 delivers, and then I think we'll take some informed steps after that.
And if you don't mind one additional follow-up, could you just remind us what would we do up front should Pacific 9 be positive?
We have not basically disclosed the schedule of the milestones. I think what we've said is they're up to 400 million of development and regulatory milestones, and they follow the standard type of criteria that you would see for these sorts of deals. So I think you can probably work out what they are quite easily. Great. Thanks for taking the questions.
There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.