Innate Pharma (IPHA) Q4 2026 earnings call transcript

Good morning and good afternoon everyone. Thank you for joining us for innate pharma's first half 2026 business update and financial results conference code. The press release and today's presentation are both available on the IR section of our website. Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risk and uncertainties that could cause actual results to defer matter early. To briefly cover today's agenda, our CEO Jonathan Dickinson will begin with a strategic overview and outlook. Mark Hutchinson, our Chief Medical Officer and Janice Morrell, our Chief Operating Officer, will then take us through updates on Laketama, IPH 4502, Monalichi Mab, and our preclinical ADC pipeline.

Rederic Lumba, our Chief Financial Officer, will then review our financial results. Jonathan will return for our upcoming catalysts and closing remarks before we open the call for Q&A. With that, I will now hand it over to Jonathan.

Thank you, Stephanie. Good morning to those joining from the U. S. and good afternoon to our European participants. Turning to slide five, the first half of 2026, together with development since the end of the period, has been marked by important progress across our focus portfolio. Starting with Laketama, in August, we announced our strategic partnership with SOBI to advance the programme in T-cell lymphoma. As announced yesterday, that partnership is now effective following the closing of the deal. And the Telemax 3, phase 3, has been initiated. We are targeting the first patient in the study in Q1, 2027, as we work toward a filing for accelerated approval in Caesaree syndrome in H2 2027. For IPH 4502, as announced in July, we completed phase 1 dose escalation and cohort enrichment enrollment, and have been seen preliminary anti-tumor activity, including objective responses in post-EV urophilial cancer, as well as in non-small cell lung cancer, and head and neck cancer, with a favourable safety profile observed to date.

We will share initial phase 1 dose escalation data at the ERTC NCI, AACR meeting on November 18th, 2026, in Barcelona. Turning to Monalooza map, enrollment in the Pacific 9 phase 3 study has been completed, and we continue to expect the phase 3 readout in the second half of 2026. Financially, our position has been strengthened by the 75 million SOBI upfront payment associated with the 30 financing. Together, these are expected to extend our projected cash runway through the end of the first quarter of 2028. Taken together, we believe these developments position and aid for several important catalysts in the second half of 2026.

Let me start with LeCouta map. LeCouta map is our anti-CUR3-DL2 antibody being developed in cutaneous T-cell lymphoma or CTCL. Turning to slide 7, as I mentioned, in August, we announced a strategic partnership with SOBI to license LeCouta map in T-cell lymphoma. The transaction has now closed. Telemac 3, our confirmatory phase 3 study in CTCL has been initiated with the first patient expected in the first quarter of 2027. In eight, we'll conduct the phase 3 study and we will file for accelerated approval in Caesaree syndrome based on the existing phase 2 telemac data. Upon the potential accelerated approval, SOBI will receive exclusive global rights to commercialize LeCouta map. Following positive phase 3 results, SOBI will be eligible to obtain full global development rights.

Under the terms of the agreement, the transaction includes a 75 million upfront payment up to 40 million in near-term milestones connected to Caesaree syndrome and up to an additional 465 million related to SOBI's option to obtain full development rights and future regulatory and commercial milestones. The agreement also includes tiered double-digit royalties on future net sales. I'll now hand it over to Marcus to review the regulatory and development path forward. Marcus.

Thank you, Jonathan. LeCouta map is now progressing towards phase 3 telemark initiation and accelerated approval filing. So from a regulatory and development perspective, the path forward is well-defined. We have FDA clearance to proceed with telemark 3, which now has been initiated with the first patient expected in the first quarter of 27. The study includes a confirmatory cohort in Caesaree syndrome and a registration of the cohort in the course of S. The existing phase 2 telemark data are intended to support an accelerated approval filing in Caesaree syndrome once telemark 3 is underway with a filing currently planned for the second half of 2027. As a reminder, LeCouta map has received breakthrough therapy designation from the FDA for relapsed or refractory Caesaree syndrome as well as fast-track designation from the FDA, prime designation from the EMA and an orphan drug status in both United States and Europe.

So with the regulatory pathway established and the SOBI partnership now effective, our focus is on advancing telemark 3 towards first patient enrollment, first quarter of 2027. Turning to the slide, please, I now move to ITH 4502, our differentiated connecting for accepted ADC, which is in phase 1 development clinical development for advanced solid tumors. IPH 45 was designed to address some of the key limitations of the first generation of connecting for ADCs. The molecule combines an exotic can to put isomerase 1 payload with our proprietary stable linker and a high affinity connecting for antibody that binds non-overlapping epitope compared with input amount beta tons. We believe these features provide an important point of differentiation as the connecting for ADC landscape continues to evolve.

Importantly, we are now beginning to see that profile translate clinically and have observed preliminary anti-tumor activity with objective responses in heavily pre-treated patients, including patients with vernial cancer following prior and photomarked by the term treatment, as well as in non-small cell lung cancer, head and neck cancer. The safety profile observed to date has been favorable with limited hematologic toxicity. We've completed dose escalation in July and are broadly tracking in line with our expectations across expansion boards with approximately 15 patients enrolled in both postive vernial cancer and head and neck cancer and somewhat lower enrollment in non-small cell lung cancer board. Data cleaning is ongoing and we look forward to presenting the initial phase 1 dose escalation data set at the ERTC NCIA CRS symposium on November 18th, 26th.

Next slide, please. Our area of particular interest for IPH 45 is endothelial cancer following prior AD treatment, while AD plus embroism of significant change to treatment landscape. Most patients progress within two years and there remains no established second line standard treatment after progression of this regime. Against that backdrop, the preliminary activity we have observed with IPH 45 or two in heavily pre-traded postive patients, including objective responses is encouraging. These remain early phase one observations and the upcoming data set will help us to determine the best advanced program. Slide 11, please. Slide 12, please. I now move forward to Mogadishoma, which is our NKG 2A antibody being co-developed with AstraZeneca in non-small cell lung cancer.

Pacific 9 is a randomized phase 3 trial with unresectable stage 3 non-small cell lung cancer patients who have not progressed following a definitive platinum-based concurred chemotherapy.

Studying road 1,051 patients in comparison to the Divalumab plus oleclumab, Divalumab plus monadizumab, and Divalumab plus placebo as a control with progression pre-survival as the primary endpoint. The program is supported by three early phase 2 studies in non-small cell lung cancer, which will be closed near course and near course 2. With enrollment complete, phase 3 data remain expected in the second half of 2026. I now hand over to Janis to briefly review the economics of our partnership with AstraZeneca.

Thank you, Marcus. As a reminder, under our monadizumab partnership with AstraZeneca, we are received to date 450 million. And the additional potential milestone in the agreement are up to 825 million, together with double-digit royalties outside Europe and 50% profit sharing in Europe.

Turning to slide 15, I'll move now to our next generation ADC pipeline. Beyond IPH 45.2, we are using our internal capabilities and technology to build a broad portfolio of differentiated ADC candidates.

Turning to slide 16, leveraging our antibody discovery and engineering expertise, we have built a comprehensive ADC platform to develop a portfolio of next generation ADCs designed to overcome the limitation of the current ones. Building on IPH 45.2 linker, which stability in patients is demonstrated by our emerging clinical data, we are developing a drug candidate portfolio around three approaches.

First, dual targeted bi-specific ADCs to address tumor antigen heterogeneity and to expand addressable indication compared to single tumor antigen targeting. Second, bi-specific ADCs with enhanced internalization to unlock the activity in antigen-low expressing tumors. And finally, dual payload ADCs using complementary mechanism of action to overcome resistance.

I know and over to Frederick for our financial results.

Thank you, Janice. I'll now provide a brief overview of our financial position for the first time for 2026. Turning to slide 18. So, out of June 30, 2026, our cash equivalent and financial set were announcing for a 21.4 million euro. That balance does not include the 75 million USD, so be a form payment equivalent to 65 million euro, nor the proceeds from the 30 million equity offering. The offering represents 30 million on gross proceeds or approximately 28 million in expected net proceeds. The primary use of proceeds is the continued clinical development of EPH 4502. The advertisements of our technical ADC portfolio and as well as general corporate purposes. Together with the Soviet front payment, these proceeds are expected to extend our cash runway through the end of the first quarter of 2028.

I now hand over to Janetta.

Thank you, Frederick. Moving to slide 20. And turning to our key catalyst for the remainder of 2026. For Likutamab, following closing of the strategic partnership with SOBI, Telemaxery has been initiated with the first patient planned for the first quarter of 2027, followed by a plan filing for accelerated approval in the second half of 2027. For IPH 4502, dose escalation enrollment is complete with preliminary anti-tumor activity and favorable safety profile observed today. We will report initial Phase 1 dose escalation data at the Monalooza map. Pacific 9 enrollment is complete with the Phase 3 readout expected in the second half of this year. So we have three important near-term catalysts across our focus portfolio. Together with a strengthened financial position that supports our continued execution of these priorities.

With that operator, we are ready to open the call for questions.

Thank you for the question. Maybe Yan, if you can take that one. Yeah, maybe I can start and let Marcus comment. I mean, we have worked on the design of the linker and based on what we have seen at ASCO published by others with their own linker. It seems that the stability of our linker that we have seen in preclinical models, including in non-human primates, seems to be translated into the human situation leading to a very limited release of a free payload, which is one of the reason of a system in the capital toxicity of some ADCs.

Yeah.

What we can add is the lily data that have been released recently actually stated based on their own data that have seen in the trial. So the instable linker was used as an explanation for the hematologic toxicity in this data set. Great. Thank you.

Yeah. Maybe I will take that question, JIT. So our expectation is that the lilylizumab will be listed in the NCCN guidelines following the accelerated approval for both Caesaree syndrome and for my co-cease funguides. I think with that listing, it seems to leave it open for physicians to be able to use the product across the different lines of therapy. So our expectation, based on the safety profile of lilylizumab, which is pretty benign, we expect that you will see some off-label usage in the first line setting.

And so, yeah, I mean, I think there's an expectation you will see that. And also, despite the fact that the accelerated approval will be in Caesaree syndrome, there will also be an expectation based on the potential listing in the NCCN guidelines for my co-cease funguides that you will also see usage in MF. Hopefully that answers your question.

Great. Appreciate that. Maybe just two other quick follow-ups. Just any initial thoughts on pricing? Do you think you could price that a premium to Mogulizumab? And then separately on Pacific Nine, in terms of just the update format, anticipate perhaps a press release at minimum for Master Zeneca, but will innate have their own press release and analyst call as well? Thank you. Yeah, so in terms of pricing, we have completed pricing research in the US, which was conducted by ZS Associates. And what we were able to establish with US payers was that we can price LeCoutimab between $500,000 and $625,000 per patient per annum. And that will be supported by our clinical data and the NCCN listing.

So, there is an expectation here that you will be able to premium pricing, particularly in an indication like Caesaree Syndrome, with a relatively low incidence. And then be able to carry that forward into the mycosis funguides indication, which is a larger indication, but still an orphan disease. So, that's pricing. So, and then with respect to Pacific Nine, you're correct. The expectation is that there will be a press release from AstraZeneca when the results are available. And we would also look to press release that as well, and potentially do some analyst calls following the availability of that primary endpoint data.

Great. Thank you. Hopefully that answers the question.

Yes. So, we have a question from Clemon Steers from Stiffel. The first question is, as does this curation and coart expansion enrollment are now complete, should we expect the initial ENA data set to be primarily a safety pharmacology update or mature enough to inform subsequent development decision? So, Marcus, maybe you can take that question.

Yeah. The question is almost the answer. So, this is out of 11 different indications and 76 patients. So, we are expecting to see relevant and informative safety data. And we are also expecting a response data from patients. And this will inform our next steps. We need to fully run the tables and we will review and disclose that as proposed on the NAM meeting.

Thank you. And there is another question from Clemon Steers. With the strength and balance sheet following the recent financing, how far along the development path could you advance IPH 45 or 2 on your own?

So, maybe I can take that. So, I think you're all aware that we did a small equity raise of 30 million euros a couple of weeks ago. The rationale behind that equity raise was to be able to progress seamlessly into the next steps for 4502. So, we're well positioned now to be able to move into the next steps. Whatever that will be and the data will dictate what that is, whether it's dose optimization. And we're equipped to be able to do that. If we would need to broaden the program, if the data supports going to potentially additional tumor types, then that would require additional funding to be able to conduct multiple dose optimizations across different tumor types.

But at least for the initial steps, we're funded to be able to take those steps and take the product forward seamlessly into dose optimization.

Hopefully that answers the question again.

So, thank you very much everybody for joining us today for our update and following our H1 results. We look forward to updating you as we progress through the important catalysts that we outlined today, which come across the remainder of the year. So, thank you for your time and see you soon.