Innate Pharma(IPHA) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of EUR 56.4 million, providing runway through the end of Q3 2026 to deliver on key milestones [26] Business Line Data and Key Metrics Changes - Lacutamab received FDA clearance to initiate the TELLOMAK III phase three trial in cutaneous T-cell lymphoma, with expectations for accelerated approval in Sézary syndrome based on robust phase two data [4][12] - IPH4502 is progressing well in its phase one trial, having reached a pharmacologically active dose and showing early signs of clinical activity [10][24] - Monalizumab is advancing in the PACIFIC-9 phase three trial, with top-line data expected in the second half of 2026 [11][24] Market Data and Key Metrics Changes - The annual incidence of Sézary syndrome is estimated at around 300 patients, with a prevalence of approximately 1,000 diagnosed patients in the U.S. [19] - For mycosis fungoides, approximately 3,000 new patients are diagnosed each year in the U.S., with one in four receiving systemic therapy [20] Company Strategy and Development Direction - The company is focusing investments on high-value clinical assets, including IPH4502, Lacutamab, and Monalizumab, while advancing next-generation ADC programs [6][24] - The development strategy for Lacutamab includes a stepwise approach starting with Sézary syndrome, followed by mycosis fungoides, and expanding to peripheral T-cell lymphoma [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path for Lacutamab, indicating that the FDA has not requested additional substantial analyses beyond existing phase two data for accelerated approval [31] - There is growing momentum among KOLs for Lacutamab to become the preferred second-line option, with expectations that it may be used ahead of Mogamulizumab in mycosis fungoides [32][33] Other Important Information - The company is streamlining its organization to align with strategic objectives and ensure it remains fit for purpose [6] - The confirmatory phase three trial for Lacutamab is set to begin in the first half of 2026, with a potential BLA submission anticipated in early 2027 [12][31] Q&A Session Summary Question: What needs to be done for the potential Lacutamab commercial launch in Sézary syndrome? - The company aims to ensure Lacutamab is included in the NCCN guidelines prior to the BLA approval [27][28] Question: What can be expected from the upcoming data set for IPH4502? - The company hopes to present data from a cohort of patients in the Padcev resistance setting, with an interesting response rate and safety data [28][29] Question: Is the FDA looking for additional analyses for Lacutamab's accelerated approval? - The FDA has not indicated a need for further substantial analyses; the BLA approval will be based on existing TELLOMAK study data [31] Question: What are the expectations for the PACIFIC-9 study readout? - The company has good expectations based on previous studies, anticipating a positive outcome for the PACIFIC-9 study [40]