Innate Pharma S.A. Q3 FY2025 earnings call

Key Points

• Jonathan Dickinson discussed strong momentum around lacutamab, including FDA clearance to initiate TELLOMAK-3 Phase III trial in cutaneous T-cell lymphoma, and a well-attended lacutamab KOL event in October with new real-world claims data.
• Focus on highest value clinical assets: IPH4502, lacutamab, and monalizumab, with investment focus on these. Streamlining organization for strategic alignment.
• Sonia Quaratino highlighted IPH4502's differentiated ADC with exatecan payload showing bystander effect and activity in PADCEV MMAE-resistant models; enrollment progressing well in first-in-human trial. Monalizumab's PACIFIC-9 Phase III trial fully enrolled with data expected in H2 2026. Lacutamab's stepwise development in CTCL, including confirmatory Phase III trial in FNSS, aiming for accelerated approval in Sézary syndrome and full approval in mycosis fungoides, and advancement in peripheral T-cell lymphoma.
• Stephanie Cornen discussed lacutamab's commercial opportunity, with initial U.S. opportunity up to $150M with accelerated approval in Sézary syndrome, expanding to ~$500M in U.S. and Europe as it moves into mycosis fungoides and secures full approval, and further upside in life cycle management.

No specific financial performance by product segment in absolute terms and revenue contribution % provided in the transcript.

Guidance

• Anticipate Phase I data from IPH4502 in H1 2026.
• Expect data from PACIFIC-9 Phase III trial of monalizumab in H2 2026.
• Potential accelerated approval for lacutamab in Sézary syndrome in 2027, monalizumab BLA filing, and IPH4502 expansion phase data.
• Cash position of EUR 56.4 million provides runway through end of Q3 2026 to deliver key milestones.

Risks

• Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. Regulatory and commercialization risks are present, but no specific detailed risks discussed in the transcript.

Q: What would you need to get done in the near term for the potential lacutamab commercial launch in Sézary syndrome? And for IPH4502 and the upcoming data set, could you give us a little bit more color on what we can see at that readout?

A: From a commercial perspective, need to ensure lacutamab is included in NCCN guidelines. For IPH4502, expect cohort data in PADCEV resistant setting with 10+ patients, looking for response rate and safety data, and potential backfilling in 1-2 other tumor types.

Q: You've indicated that FDA views an accelerated approval pathway here for lacutamab as viable once the Phase III study is underway. Could you just expand whether FDA is looking for any additional supplementary analyses beyond the existing Phase II data set as part of that accelerated approval package? And then just second, based off of the feedback from the October KOL event. Do you have a sense of growing momentum from the KOLs for lacutamab to become the preferred second-line option here? And should we expect mogalizumab to naturally move later in the treatment paradigm?

A: FDA has not indicated need for additional substantial analysis; BLA approval based on existing TELLOMAK data. KOLs see good momentum for lacutamab, with excitement around its potential as a game changer. Lacutamab is positioned for post-mogamulizumab use, with potential for off-label first-line use.

Q: So I appreciate your comments on how you plan to file the accelerated approval application by the end of 2026. So what -- does this mean you're still hoping to get a partner on board? And in your previous conversations with potential partners, how much stress was there in terms of getting a clear signal from the FDA and a protocol blessed by the FDA?

A: Partner discussions considered FDA acceptance of protocol as important. Company keeps options open for partnering, evaluating financial options to support growth initiatives.

Q: What specific safety signals would you be looking out for, especially when you would like to see this differentiated against other TOPO1 inhibitor ADCs? And the second question is, so what's the thought process now for the ANKET platform, especially them taking a little bit of a backseat? What's the long-term plan for that platform?

A: For IPH4502, looking for well-tolerated profile and avoiding specific adverse events. On ANKET platform, finalizing study for IPH6501, evaluating data from IPH6101 with Sanofi, and will make decisions based on clinical data.

Q: Yes, Bill on for Dana. I change it up a little bit, just asking about monalizumab. So I guess I'm just curious, can you just give us some, I guess, expectations for the readout in the second half of '26? Sort of what gives you the confidence that monalizumab, I guess, and durva can actually win out against durva?

A: Have good expectations for PACIFIC-9 study based on COAST Phase II study results, which showed adding monalizumab to durva provided 12 months median PFS on top of durva, indicating high chance of positive study.