Q2 2026 Innate Pharma SA Earnings Call
Speaker #2: Hello, everyone. Thank you for joining us, and welcome to the Innate Pharma First Half 2026 Business Update and Financial Results. After today's prepared remarks, we will host a question-and-answer session.
Operator 2: Hello, everyone. Thank you for joining us, and welcome to the Innate Pharma First Half 2026 Business Update and Financial Results. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. I will now hand the conference over to Stéphanie Cornen, Vice President, Investor Relations, Communication, and Commercial. Stéphanie, please go ahead.
Speaker #2: If you would like to ask a question, please press *1 to raise your hand. To withdraw your question, press *1 again. I will now hand the conference over to Stephanie Cornyn, Vice President of Investor Relations, Communication, and Commercial.
Speaker #2: Stephanie, please go ahead.
Speaker #3: Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma's First Half 2026 Business Update and Financial Results Conference Call. The press release and today's presentation are both available on the IR section of our website.
Stéphanie Cornen: Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma's First Half 2026 Business Update and Financial Results conference call. 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 risks and uncertainties that could cause actual results to differ materially. To briefly cover today's agenda, our CEO, Jonathan Dickinson, will begin with a strategic overview and outlook. Markus Jensen, our Chief Medical Officer, and Yannis Morel, our Chief Operating Officer, will then take us through updates on lacutamab, IPH4502, monalizumab, and our preclinical ADC pipeline. Frédéric Lombard, our Chief Financial Officer, will then review our financial results. Jonathan will return for our upcoming catalyst and closing remarks before we open the call for Q&A.
Speaker #3: Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially.
Speaker #3: To briefly cover today's agenda, our CEO, Jonathan Dickinson, will begin with a strategic overview and outlook. Marcus Jensen, our Chief Medical Officer, and Yannis Morel, our Chief Operating Officer, will then take us through updates on Lacutama, IPH4502, monalizumab, and our preclinical ADC pipeline.
Speaker #3: Frédéric Lombard, 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.
Speaker #3: With that, I will now hand it over to Jonathan.
Stéphanie Cornen: With that, I will now hand it over to Jonathan.
Speaker #4: Thank you, Stephanie. Good morning to those joining from the US, and good afternoon to our European participants. Turning to slide 5, the first half of 2026, together with developments since the end of the period, has been marked by important progress across our focus portfolio.
Jonathan Dickinson: Thank you, Stéphanie. Good morning to those joining from the US, and good afternoon to our European participants. Turning to slide 5. The H1 2026, together with developments since the end of the period, has been marked by important progress across our focused portfolio. Starting with lacutamab, in August, we announced our strategic partnership with Sobi to advance the program in T-cell lymphoma. As announced yesterday, that partnership is now effective following the closing of the deal, and the TELLOMAK-3, phase III, 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 Sézary syndrome in H2 2027.
Speaker #4: Starting with Lacutamab, in August, we announced our strategic partnership with SOBI to advance the program in T-cell lymphoma. As announced yesterday, that partnership is now effective following the closing of the deal.
Speaker #4: And the Telemach 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 Caesarea syndrome in H2 2027.
Speaker #4: For IPH4502, as announced in July, we completed Phase 1 dose escalation and cohort enrichment enrollment, and have seen preliminary antitumor activity, including objective responses in post-EV urothelial cancer.
Jonathan Dickinson: For IPH4502, as announced in July, we completed phase I dose escalation and cohort enrichment enrollment and have seen preliminary anti-tumor activity, including objective responses in post-EV urothelial cancer, as well as in non-small cell lung cancer and head and neck cancer, with a favorable safety profile observed to date. We will share initial phase I dose escalation data at the EORTC-NCI-AACR meeting on 18 November 2026 in Barcelona. Turning to monalizumab, enrollment in the PACIFIC-9 phase III study has been completed, and we continue to expect the phase III readout in the H2 2026. Financially, our position has been strengthened by the 75 million USD Sobi upfront payment associated with the closing of the deal and the 30 million EUR equity financing. Together, these are expected to extend our projected cash runway through the end of the Q1 2028.
Speaker #4: As well as in non-small cell lung cancer and head and neck cancer, with a sustainable safety profile observed to date. We will share initial Phase 1 dose escalation data at the EORTC-NCI-AACR meeting on November 18, 2026, in Barcelona.
Speaker #4: Turning to Monalizumab, 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.
Speaker #4: Financially, our position has been strengthened by the $75 million SOBI upfront payment associated with the closing of the deal, and the $30 million equity financing.
Speaker #4: 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 Innate for several important catalysts in the second half of 2026.
Jonathan Dickinson: Taken together, we believe these developments position Innate for several important catalysts in the H2 2026. Let me start with lacutamab. Lacutamab is our anti-KIR3DL2 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 lacutamab in T-cell lymphoma. The transaction has now closed. TELLOMAK-3, our confirmatory phase III study in CTCL, has been initiated with the first patient expected in the Q1 2027. Innate will conduct the phase III study, and we will file for accelerated approval in Sézary syndrome based on the existing phase II TELLOMAK data. Upon the potential accelerated approval, Sobi will receive exclusive global rights to commercialize lacutamab. Following positive phase III results, Sobi will be eligible to obtain full global development rights.
Speaker #4: Let me start with Lacutamab. Lacutamab is our anti-KIR 3DL2 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 Lacutamab in T-cell lymphoma.
Speaker #4: The transaction has now closed. Telemach 3, our confirmatory Phase 3 study in cTCL, has been initiated, with the first patient expected in the first quarter of 2027.
Speaker #4: INNATE will conduct the Phase 3 study, and we will file for accelerated approval in Caesarea syndrome based on the existing Phase 2 Telemach data.
Speaker #4: Upon the potential accelerated approval, SOBI will receive exclusive global rights to commercialize Lacutamab. Following positive Phase 3 results, SOBI will be eligible to obtain full global development rights.
Speaker #4: Under the terms of the agreement, the transaction includes a $75 million upfront payment and up to $40 million in near-term milestones connected to Caesarea syndrome.
Jonathan Dickinson: Under the terms of the agreement, the transaction includes a 75 million USD upfront payment, up to 40 million USD in near-term milestones connected to Sézary syndrome, and up to an additional 465 million USD 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 Markus to review the regulatory and development path forward. Markus.
Speaker #4: 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.
Speaker #4: I'll now hand it over to Marcus to review the regulatory and development path forward. Marcus.
Speaker #5: Thank you, Jonathan. Lacutamab is now progressing towards Phase 3 TELEMAK initiation and planned accelerated approval filing. So from a regulatory and development perspective, the path forward is well-defined.
Markus Jensen: Thank you, Jonathan. lacutamab is now progressing towards phase III TELLOMAK initiation and planned accelerated approval filing. From a regulatory and development perspective, the path forward is well-defined. We have FDA clearance to proceed with TELLOMAK-3, which now has been initiated with the first patient expected in Q1 2027. The study includes a confirmatory cohort in Sézary syndrome and a registrational cohort in Mycosis fungoides. The existing phase II TELLOMAK data are intended to support an accelerated approval filing in Sézary syndrome once TELLOMAK-3 is underway, with the filing currently planned for H2 2027. As a reminder, lacutamab has received Breakthrough Therapy designation from the FDA for relapsed or refractory Sézary 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.
Speaker #5: We have FDA clearance to proceed with Telemach 3, which has now been initiated, with the first patient expected in the first quarter of 2027.
Speaker #5: The study includes a confirmatory cohort in Caesarea syndrome and a registrational cohort in mucosal sphingitis. The existing Phase 2 Telemach data are intended to support an accelerated approval filing in Caesarea syndrome once Telemach 3 is underway.
Speaker #5: With a filing currently planned for the second half of 2027. As a reminder, lacutamab has received Breakthrough Therapy designation from the FDA for relapsed or refractory Sezary syndrome, as well as Fast Track designation from the FDA, PRIME designation from the EMA, and Orphan Drug status in both the United States and Europe.
Speaker #5: So, with the regulatory pathway established and the SOBI partnership now effective, our focus is on advancing Telemach 3 towards first patient enrollment in Q1 2027.
Markus Jensen: With the regulatory pathway established and the Sobi partnership now effective, our focus is on advancing TELLOMAK-3 towards first patient enrollment Q1 2027. Turning the slide, please. I now move to IPH4502, our differentiated Nectin-4 exatecan ADC, which is in phase I clinical development for advanced solid tumors. IPH4502 was designed to address some of the key limitations of the first generation of Nectin-4 ADCs. The molecule combines an exatecan topoisomerase 1 payload with our proprietary stable linker and a high-affinity Nectin-4 antibody that binds non-overlapping epitope compared with enfortumab vedotin. We believe these features provide an important point of differentiation as the next ADC landscape continues to evolve.
Speaker #5: Turning slide, please. I now move to IPH4502, our differentiated nic-4-acetic ADC, which is in Phase 1 clinical development for advanced solid tumors.
Speaker #5: IPH45 was designed to address some of the key limitations of the first generation of nicotine-4 ADCs. The molecule combines an axetic topoisomerase-1 payload with our proprietary stable linker, and a high-affinity nicotine-4 antibody that binds a non-overlapping epitope compared with infotumor beta.
Speaker #5: We believe these features provide an important point of differentiation as the nic-4-ADC landscape continues to evolve. Importantly, we are now beginning to see that this profile translates clinically and have observed preliminary anti-tumor activity with objective responses in heavily pre-treated patients, including patients with urothelial cancer following prior enfortumab treatment, as well as in non-small cell lung cancer and head and neck cancer.
Markus Jensen: 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 urothelial cancer following prior enfortumab vedotin platinum 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 hematological toxicity. We completed dose escalation in July and are broadly tracking in line with our expectations across expansion cohorts, with approximately 15 patients enrolled in both post-EV urothelial cancer, head and neck cancer, and somewhat lower enrollment in non-small cell lung cancer cohort. Data cleaning is ongoing, and we look forward to presenting the initial Phase 1 dose escalation data set at the EORTC-NCI-AACR symposium on 18 November 2026. Next slide, please. Our area of particular interest for IPH4502 is urothelial cancer following prior EV treatment.
Speaker #5: The safety profile observed to date has been favorable, with limited hematological toxicity. We completed dose escalation in July and are broadly tracking in line with our expectations across expansion cohorts, with approximately 15 patients enrolled in both postively urothelial cancer and head and neck cancer, and somewhat lower enrollment in the non-small cell lung cancer cohort.
Speaker #5: Data cleaning is ongoing, and we look forward to presenting the initial Phase 1 dose-escalation dataset at the ERTC NCI/ACR Symposium on November 18, 2026.
Speaker #5: Next slide, please. Our area of particular interest for IPH45 is urothelial cancer following prior ED treatment. While ED plus pembrolizumab has significantly changed the treatment landscape, most patients progress within two years, and there remains no established second-line standard treatment after progression on this regimen.
Markus Jensen: While EV plus pembrolizumab has significantly changed the treatment landscape, most patients progress within 2 years, and there remains no established second line standard treatment after progression of this regimen. Against that backdrop, the preliminary activity we have observed with IPH4502 in heavily pre-treated post-EV patients, including objective responses, is encouraging. These remain early Phase 1 observations, and the upcoming data set will help us to determine how to best advance the program. Slide 11, please. Slide 12, please. I now move forward to monalizumab, which is our NKG2A 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 concurrent chemoradiotherapy.
Speaker #5: Against that backdrop, the preliminary activity we have observed with IPH4502 in heavily pre-treated, PD-positive patients, including objective responses, is encouraging. These remain early phase 1 observations, and the upcoming dataset will help us to determine how to best advance the program.
Speaker #5: Slide 11, please. Slide 12, please. I now move forward to Monalizumab, which is our NKG2A antibody being co-developed for cancer. Specific 9 is a randomized Phase 3 trial with unresectable stage III non-small cell lung cancer.
Speaker #5: Patients who have not progressed following definitive platinum-based concurrent chemoradiotherapy. The study enrolled 1,051 patients. It compares durvalumab plus oleclumab, durvalumab plus monalizumab, and durvalumab plus placebo as a control, with progression-free survival as the primary endpoint.
Markus Jensen: Study enrolled 1,051 patients and compares durvalumab plus oleclumab, durvalumab plus monalizumab, and durvalumab plus placebo as a control with progression-free survival as the primary endpoint. The program is supported by three earlier phase II studies in non-small cell lung cancer, including COAST, NeoCOAST, and NeoCOAST-2. With enrollment complete, phase III data remain expected in the H2 2026. I now hand over to Yannis to briefly review the economics of our partnership with AstraZeneca.
Speaker #5: The program is supported by three earlier Phase 2 studies in non-small cell lung cancer, including COAST, NeoCOAST, and NeoCOAST-2. With enrollment complete, Phase 3 data remain expected in the second half of 2026.
Speaker #5: I now hand over to Yannis to briefly review the economics of our partnership with AstraZeneca.
Speaker #3: Thank you, Marcus. As a reminder, under our monalizumab partnership with AstraZeneca, we have received, to date, $450 million, and the additional potential milestones in the agreement are up to $825 million.
Yannis Morel: Thank you, Markus. As a reminder, under our monalizumab partnership with AstraZeneca, we have received up to date EUR 450 million. The additional potential milestone in the agreement are up to EUR 825 million, together with double-digit royalties outside Europe and 50% profit sharing in Europe. Turning to slide 15, I will move now to our next generation ADC pipeline. Beyond IPH4502, 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 IPH4502 linker, which stability in patients is demonstrated by our emerging clinical data, we are developing a drug candidate portfolio around three approaches.
Speaker #3: 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.
Speaker #3: Beyond IPH 4502, we are using our internal capabilities and technology to build a broad portfolio of differentiated ADC candidates. Turning to slide 16, and 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 limitations of current ones.
Speaker #3: Building on IPH4502 linker, whose stability in patients is demonstrated by our emerging clinical data, we are developing a drug candidate portfolio around three approaches.
Speaker #3: First, dual-targeted bispecific ADCs to address tumor antigen heterogeneity and to expand addressable indications compared to single tumor antigen targeting. Second, bispecific ADCs with enhanced internalization to unlock activity in antigen low-expressing tumors.
Yannis Morel: First, dual targeted bispecific ADCs to address tumor antigen heterogeneity and to expand address eligible indication compared to single tumor antigen targeting. Second, bispecific ADCs with enhanced internalization to unlock the activity in antigen-low expressing tumors. Finally, dual payload ADCs using complementary mechanism of action to overcome resistance. I now hand over to Frédéric for our financial results.
Speaker #3: And finally, dual-payload ADCs using complementary mechanisms of action to overcome resistance. I'll now hand over to Frederic for our financial results.
Speaker #5: Thank you, Yannis. I'll now provide a brief overview of our financial position for the first half of 2026. Turning to slide 18, as of June 30, 2026, our cash equivalents and financial assets amounted to €21.4 million.
Frédéric Lombard: Thank you, Yannis. I will now provide a brief overview of our financial position for the H1 2026. Turning to slide 18. As of 30 June 2026, our cash equivalent and financial assets were announcing for EUR 21.4 million. That balance does not include the 75 million USD Sobi up-front payments, equivalent to EUR 65 million, nor the proceeds from the EUR 30 million equity offering. The offering represents EUR 30 million on gross proceed or approximately EUR 28 million in expected net proceeds. The primary use of proceeds is the continued clinical development of IPH4502, the advancement of our preclinical ADCs portfolio, and general corporate purposes. Together with the Sobi up-front payment, these proceeds are expected to extend our cash runway through the end of the Q1 2028. I now hand over to Jeanette.
Speaker #5: That balance does not include the $75 million, so the upfront payment equivalent to €65 million, nor the proceeds from the €30 million equity offering.
Speaker #5: The offering represents $30 million in gross proceeds, or approximately $28 million in expected net proceeds. The primary use of proceeds is the continued clinical development of IPH4502.
Speaker #5: The advancements of our preclinical ADC portfolio, as well as general corporate purposes. Together with the SOBI upfront payment, these proceeds are expected to extend our cash runway through the end of the first quarter of 2028.
Speaker #5: I'll now hand over to Jonathan.
Speaker #6: Thank you, Frederic. Moving to slide 20, and turning to our key catalyst for the remainder of 2026. For Leucotomab, following the closing of the strategic partnership with SOBI, TELMARK-3 has been initiated, with the first patient planned for the first quarter of 2027.
Jonathan Dickinson: Thank you, Frédéric. Moving to slide 20 and turning to our key catalysts for the remainder of 2026. For lacutamab, following closing of the strategic partnership with Sobi, TELLOMAK-3 has been initiated with the first patient planned for Q1 2027, followed by a planned filing for accelerated approval in H2 2027. For IPH4502, dose escalation enrollment is complete with preliminary anti-tumor activity and a favorable safety profile observed to date. We will report initial phase I dose escalation data at the EORTC-NCI-AACR meeting on 18 November 2026. For monalizumab, PACIFIC-9 enrollment is complete with the phase III readout expected in H2 this year. 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.
Speaker #6: This will be followed by a planned filing for accelerated approval in the second half of 2027. For IPH4502, dose escalation enrollment is complete, with preliminary anti-tumor activity and a favorable safety profile observed to date.
Speaker #6: We will report initial Phase 1 dose-escalation data at the EORTC-NCI-AACR meeting on November 18, 2026. And for monalizumab, PACIFIC-9 enrollment is complete, with the Phase 3 readout expected in the second half of this year.
Speaker #6: 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.
Speaker #6: With that, operator, we are ready to open the call for questions.
Jonathan Dickinson: With that, operator, we are ready to open the call for questions.
Speaker #1: We will now begin the question and answer session. If you would like to ask a question, please press star one to raise your hand.
Operator 2: 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. Please stand by while we compile the Q&A roster. Your first question comes from the line of Daina Graybosch with Leerink Partners. Your line is open, Daina. Please go ahead.
Speaker #1: 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.
Speaker #1: If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Dana Greybosh with Lyrink Partners.
Speaker #1: Your line is open, Dana. Please go ahead.
Speaker #4: Good morning, everyone. I'll tell you updates. So just one for me. You have Bill on for Dana. So, we've seen the prior expertise: hand-based ADCs show some pretty good activity in the post-Padstep setting, but it did have some pretty high heme toxicities.
Daina Graybosch: Hey, morning everyone. Congrats on the updates. Just one for me. Bill, one for Daina. We have seen the prior exatecan-based ADC show some pretty good activity in the post PADCEV setting, but it did have some pretty high heme toxicities. Can you talk about IPH4502's stable linker design and what gives you confidence you will not see the same sort of issues? Thank you.
Speaker #4: And so, can you talk about IPH45 stable linker design, and sort of what gives you confidence you won't see the same sort of issues?
Speaker #4: Thank you.
Speaker #6: Thank you for the question. Maybe, Yannis, you can take that one.
Jonathan Dickinson: Thank you for the question. Maybe Yannis, you can take that one.
Speaker #3: 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 seemed 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 free payload.
Yannis Morel: Yeah, maybe I can start and let Markus comment. 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 the systemic pathological toxicity of some ADCs.
Speaker #3: Which is one of the reasons for the systemic pathological toxicity of some ADCs.
Markus Jensen: Yeah. What we can add is the Lilly data that have been released recently actually state that based on their own data they have seen in the trial. The instable linker was used as an explanation for the hematologic toxicity in this data set.
Speaker #5: Can I add, the Lilly data that have been released recently actually state that, based on their own data, they have seen in the trial.
Speaker #5: So, the unstable linker was used as an explanation for the hematologic toxicity in this data set.
Speaker #4: Great. Thank you.
Daina Graybosch: Great. Thank you.
Speaker #1: Your next question comes from the line of Jeet Mukherji with US Bancorp BTIG. Your line is open, Jeet. Please go ahead.
Operator 2: Your next question comes from the line of Jeet Mukherjee with BTIG. Your line is open, Jeet. Please go ahead.
Speaker #7: Great. Good morning, and thanks for taking the question. So, pending an accelerated approval there, could you speak to the potential for frontline off-label use for lacutamab and Sézary syndrome, given that seems to be the case with monalizumab?
Jeet Mukherjee: Great. Good morning, and thanks for taking the question. Pending an accelerated approval there, could you speak to the potential for frontline off-label use for lacutamab in Sézary syndrome, given that seems to be the case with mogamulizumab? I have a follow-up question.
Speaker #7: And I have a follow-up question.
Speaker #6: Yeah, maybe I will take that question, Jeet. So, our expectation is that leucotomab will be listed in the NCCN guidelines following the accelerated approval for both Sézary syndrome and for mycosis fungoides.
Jonathan Dickinson: Yeah. Maybe I will take that question, Jeet. Our expectation is that lacutamab will be listed in the NCCN guidelines following the accelerated approval for both Sézary syndrome and for mycosis fungoides. 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. Our expectations based on the safety profile of lacutamab, which is pretty benign, we expect that you will see some off-label usage in the first-line setting. Yeah, I think there's an expectation you will see that. Also, despite the fact that the accelerated approval will be in Sézary syndrome, there will also be an expectation based on the potential listing in the NCCN guidelines for mycosis fungoides that you will also see usage in MF. Hopefully that answers your question.</seg <seg id="3">Great. Appreciate that. Maybe just two other quick follow-ups. Just any initial thoughts on pricing? Do you think you could price at a premium to mogamulizumab? Separately on PACIFIC-9, in terms of just the update format, anticipate perhaps a press release at minimum from AstraZeneca, but will Innate have their own press release and analyst call as well? Thank you.
Speaker #6: 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.
Speaker #6: So our expectation, based on the safety profile of Leucotomab, which is pretty benign, is that we will see some off-label usage in the first-line setting.
Speaker #6: 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 Sézary syndrome, there will also be an expectation, based on the potential listing in the NCCN guidelines for mycosis fungoides, that you will also see usage in MF.
Speaker #6: Hopefully, that answers your question.
Speaker #7: Great, appreciate that. Maybe just two other quick follow-ups. Just any initial thoughts on pricing? Do you think you could price at a premium to monalizumab?
Jeet Mukherjee: Great. Appreciate that. Maybe just two other quick follow-ups. Just any initial thoughts on pricing? Do you think you could price at a premium to mogamulizumab? Separately on PACIFIC-9, in terms of just the update format, anticipate perhaps a press release at minimum from AstraZeneca, but will Innate have their own press release and analyst call as well? Thank you.
Speaker #7: And then, separately, on PACIFIC-9, in terms of just the update format, do you anticipate perhaps a press release at minimum from AstraZeneca? But will Innate have their own press release and analyst call as well?
Speaker #7: Thank you.
Speaker #6: Yeah. So in terms of pricing, we have completed pricing research in the US, which was conducted by ZS Associates. What we were able to establish with US payers was that we can price Leucotomab between $500,000 and $625,000 per patient per annum.
Jonathan Dickinson: 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 lacutamab between $500,000 and $625,000 per patient per annum. And that will be supported by our clinical data in the NCCN listing. So there is an expectation here that you would be able to achieve premium pricing, particularly in an indication like Sézary syndrome, with a relatively low incidence, and then be able to carry that forward into the mycosis fungoides indication, which is a larger indication, but still an orphan disease. So that's pricing. And then, with respect to PACIFIC-9, you're correct.
Speaker #6: And that would be supported by our clinical data and the NCCN listing. So there is an expectation here that you would be able to achieve premium pricing, particularly in an indication like Caesarean syndrome, with a relatively low incidence.
Speaker #6: And then be able to carry that forward into the mycosis fungoides indication, which is a larger indication, but still an orphan disease. So that's pricing.
Speaker #6: So, and then with respect to Pacific 9, you're correct. The expectation is that there will be a press release from AstraZeneca when the results are available.
Jonathan Dickinson: 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.
Speaker #6: 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.
Speaker #7: Great. Thank you.
Jeet Mukherjee: Great. Thank you.
Speaker #6: Hopefully, that answers the question.
Jonathan Dickinson: Hopefully that answers the question.
Speaker #1: The next question will be read by Stephanie Cornyn. Stephanie, please go ahead.
Operator 2: The next question will be read by Stéphanie Cornen. Stéphanie, please go ahead.
Stéphanie Cornen: Yes. We have a question from Clémence Thiers from Jefferies. The first question is, as dose escalation and cohort expansion enrollment are now complete, should we expect the initial EHA data set to be primarily a safety pharmacology update or mature enough to inform subsequent development decisions?
Speaker #8: Yes. So, we have a question from Clémence Thiers from Stiefel. The first question is: as dose escalation and cohort expansion enrollment are now complete, should we expect the initial INNATE data set to be primarily a safety/pharmacology update, or mature enough to inform subsequent development decisions?
Speaker #6: So, Marcus, maybe you can take that question.
Jonathan Dickinson: Markus, maybe you can take that question.
Speaker #5: 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.
Markus Jensen: Yeah. The question is almost the answer. This is out of 11 different indications and 76 patients. We are expecting to see relevant and informative safety data. We are also expecting response data from patients, and this will inform our next steps. We need to fully run the table, and we will review and disclose that as proposed on the EHA meeting.
Speaker #5: And we are also expecting 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 at the INNATE meeting.
Speaker #8: Thank you. And there is another question from Clémence. With the strengthened balance sheet following the recent financing, how far along the development path could you advance IPH4502 on your own?
Stéphanie Cornen: Thank you. There is another question from Clémence Thiers. With the strengthened balance sheet following the recent financing, how far along the development path could you advance IPH4502 on your own?
Speaker #6: So maybe I can take that. I think you're all aware that we did a small equity raise of $30 million a couple of weeks ago.
Jonathan Dickinson: So maybe I can take that. I think you are all aware that we did a small equity raise of EUR 30 million 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 are well positioned now to be able to move into the next steps, whatever that will be. The data will dictate what that is, whether it is dose optimization. We are 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 are funded to be able to take those steps and take the product forward seamlessly into dose optimization.
Speaker #6: 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.
Speaker #6: Whatever the data will show will dictate what that is—whether it's dose optimization—and we're equipped to be able to do that.
Speaker #6: 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.
Speaker #6: 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.
Speaker #6: Hopefully, that answers the question again.
Jonathan Dickinson: Hopefully that answers the question again.
Speaker #1: We have now reached the end of the Q&A session. I will turn the call back to Jonathan Dickinson, CEO, for closing remarks.
Operator 2: We have now reached the end of the Q&A session. I will turn the call back to Jonathan Dickinson, CEO, for closing remarks.
Speaker #6: Thank you very much, everybody, for joining us today for our update following our H1 results. We look forward to updating you as we progress through the important catalysts that we outlined today, which will occur throughout the remainder of the year.
Jonathan Dickinson: Thank you very much, everybody, for joining us today for our update 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. Thank you for your time, and see you soon.
Speaker #6: So, thank you for your time, and see you soon.
Speaker #1: This concludes today's call. Thank you for attending. You may now disconnect.
Operator 2: This concludes today's call. Thank you for attending. You may now disconnect.
Jonathan Dickinson: Good.
Speaker #5: Good.
Stéphanie Cornen: Bye.
