Innate Pharma (NASDAQ:IPHA) outlined progress across its prioritized oncology pipeline and reviewed full-year 2025 financial results, emphasizing a streamlined strategy centered on three clinical programs: lacutamab, IPH4502, and monalizumab. Management also highlighted an AstraZeneca-partnered program, IPH5201, with upcoming interim data to be presented at a major medical meeting.
Strategy refocus and organizational streamlining
Chief Executive Officer Jonathan Dickinson said Innate has concentrated investment on what it views as its “three highest value clinical assets”—IPH4502, lacutamab, and monalizumab—while continuing to leverage internal antibody engineering expertise and its antibody-drug conjugate (ADC) platform. He added that the company has “streamlined the organization” to support more disciplined capital allocation and an “agile structure,” noting that a redundancy plan is expected to be completed by the end of April.
Lacutamab: phase III design and stepwise regulatory approach in CTCL
Chief Medical Officer Sonia Quaratino reviewed lacutamab’s development in cutaneous T-cell lymphoma (CTCL), citing phase II TELLOMAK results that demonstrated “clinically meaningful and durable activity” in mycosis fungoides (MF) and Sézary syndrome (SS), along with reported quality-of-life improvement and a favorable safety and tolerability profile. She said the program has established a regulatory foundation, including Breakthrough Therapy designation in relapsed or refractory SS, as well as Fast Track, PRIME, and Orphan Drug designations.
Innate has received FDA clearance to proceed with TELLOMAK 3, an open-label, multicenter, randomized comparative phase III trial designed as a confirmatory study for SS and a registrational study for MF. The company said it expects to initiate TELLOMAK 3 in the second half of 2026 as it evaluates financing options.
Quaratino detailed the study structure:
- Cohort 1 (Sézary syndrome): Patients with any stage SS who failed at least one prior systemic therapy, including mogamulizumab; randomized 1:1 to lacutamab or romidepsin.
- Cohort 2 (mycosis fungoides): Patients with MF from stage 1B to stage 4 who failed at least one prior systemic therapy; randomized 1:1 to lacutamab or mogamulizumab.
- Primary endpoint: Progression-free survival (PFS) by blinded independent central review for both cohorts.
- Key secondary endpoints: Overall survival in SS; quality of life and pruritus in MF.
She said the two cohorts are treated as independent populations with separate sample size estimates and powering. Quaratino also reiterated a “stepwise” regulatory concept: phase II TELLOMAK data in SS are intended to support a potential accelerated approval once the confirmatory phase III trial is underway, while the MF cohort’s PFS endpoint is expected to support full approval in the U.S. and Europe. She added that enrollment in MF may be faster due to the larger patient population, potentially enabling an earlier completion of the primary analysis in that indication.
On the commercial opportunity, Quaratino cited Innate’s estimates of approximately 300 incident SS patients per year in the U.S. and a prevalence of about 1,000, with more than 85% treated in academic centers and a large proportion concentrated in roughly 50 key institutions. MF was described as larger, with about 3,000 incident patients per year and prevalence around 12,000 in the U.S. She also referenced mogamulizumab as a benchmark, stating it generated approximately $300 million in annual sales in 2025 and is projected to reach $350 million in 2026. Innate framed a stepwise commercial opportunity “up to EUR 150 million” in SS, expanding to “over EUR 500 million” across SS and MF in the second-line setting, with potential upside in earlier lines over time.
During Q&A, Dickinson said Innate is evaluating both business development partnerships and royalty financing structures for lacutamab, with the goal of bringing the drug to patients “in the fastest way possible” while maximizing long-term shareholder value. He said Innate expects to run the phase III study under either financing approach and maintain control of timelines and regulatory interactions. The company did not provide a timeline for concluding negotiations beyond saying it hopes to make a decision “in the not too distant future.”
When asked about potential commercial build-out, management said no decision has been made on self-commercialization versus partnering. If Innate were to commercialize in-house, Dickinson said the concentration of CTCL care in a limited number of U.S. centers could allow a relatively small footprint, estimating a sales team of around 20 people, medical affairs of 5–6 people, and a “handful” of access personnel.
IPH4502: next-generation Nectin-4 ADC shows early signals in phase I
Innate highlighted IPH4502, a Nectin-4-targeting ADC using an exatecan (topoisomerase I inhibitor) payload. Chief Operating Officer Yannis Morel described the molecule as designed to improve safety and efficacy via a proprietary humanized antibody binding a “distant and non-overlapping epitope versus Enhertu,” paired with a “stable, cleavable, and hydrophilic linker” intended to minimize release of free payload in circulation. Management emphasized exatecan’s bystander activity and said preclinical studies showed activity in models resistant to enfortumab vedotin (PADCEV).
In new preclinical commentary, the company said IPH4502 demonstrated meaningful antitumor activity in models with low Nectin-4 expression where other topoisomerase I ADCs in development showed a loss of efficacy, which Innate said could be important for tumors with low to moderate expression.
Quaratino said IPH4502 is being evaluated in a first-in-human phase I trial using an adaptive Bayesian design with backfill cohorts across selected advanced solid tumors known to express Nectin-4, with sites in the U.S. and France. She said enrollment in dose escalation has progressed well, the maximum tolerated dose is being explored, and the company is enriching cohorts at “pharmacologically active dose levels,” including urothelial cancer patients relapsed or refractory to enfortumab vedotin, as well as other tumor types.
Management said it has observed preliminary antitumor activity in heavily pretreated patients and that the safety profile has been favorable to date. In Q&A, Dickinson said interest in the program is significant and that competitor developments in the Nectin-4 ADC space “reinforce” IPH4502’s positioning, particularly in the post-PADCEV setting. Quaratino added that Innate has established the maximum tolerated dose, describing it as consistent with expectations for other exatecan-based assets, and said activity has been observed at therapeutic doses in different tumor types, though she declined to provide specifics while the study is ongoing. She said the company aims to present phase I data at a medical conference once mature, and that planned outputs include safety, pharmacokinetics, levels of free payload, efficacy readouts, and retrospective assessment of tumor Nectin-4 expression from screening biopsies.
On the urothelial cancer opportunity, Innate discussed focusing initially on patients who progress after enfortumab vedotin, citing real-world data presented on the call indicating limited options and poor outcomes in that setting. The company said time to next treatment is around 3–5 months and overall survival around 7–8 months with chemotherapy-based regimens, underscoring what it described as a therapeutic gap post-EV.
AstraZeneca-partnered programs: monalizumab readout and IPH5201 AACR presentation
Innate reiterated that monalizumab, an anti-NKG2A antibody partnered with AstraZeneca, is in the phase III PACIFIC-9 trial in non-small cell lung cancer. Quaratino said the trial has completed enrollment with approximately 999 patients randomized 1:1:1 across three arms: durvalumab plus oleclumab, durvalumab plus monalizumab, and durvalumab alone, in patients who have not progressed following platinum-based chemoradiotherapy. The primary endpoint is progression-free survival, and data are expected in the second half of 2026.
Innate also discussed IPH5201, a first-in-class antibody targeting CD39, being studied in the MATISSE phase II trial in early-stage lung cancer in combination with durvalumab and standard chemotherapy. The company said a pre-planned interim analysis has been selected for an oral presentation in a clinical trial plenary session at the AACR Annual Meeting in April in San Diego. During Q&A, Morel said the AACR presentation will cover an interim analysis on the first 40 patients, noting the study includes up to 70 patients and is continuing.
Morel also reviewed Innate’s rationale for CD39 inhibition, describing CD39 as an upstream enzyme in the ATP-to-adenosine pathway and explaining that blocking CD39 may both limit adenosine accumulation and promote ATP accumulation, which he said is immune-stimulating through P2X receptors—an effect Innate has shown in preclinical models, particularly when combined with chemotherapy.
On financial terms, Innate said the monalizumab agreement includes up to $1.275 billion in milestones; it has received $450 million and remains eligible for up to $825 million in potential additional payments. If approved, Innate would receive double-digit royalties on sales in the U.S. and rest of world, while in Europe, where Innate is contributing 30% of PACIFIC-9 funding, it would receive 50% of profit and has an option to co-promote. For IPH5201, Innate said the deal is worth up to $885 million in milestones; it has received $60 million and remains eligible for up to $825 million. Innate said the structure includes an option to co-fund phase III trials for 50% profit in Europe and co-promotion rights, or alternatively royalties.
Financial results: lower R&D spend and cash runway into Q3 2026
Chief Financial Officer Frédéric Lombard reported 2025 revenue and other income of EUR 9 million, including EUR 2.8 million from licensing and collaboration agreements (primarily recognition of proceeds from AstraZeneca and Sanofi partnerships) and EUR 6.2 million in governmental funding for research expenditures.
Operating expenses totaled EUR 63 million, with 73% related to R&D. R&D expenses were EUR 43.6 million, down 16% year over year, which Lombard attributed to study maturity and lower indirect R&D expenses due to reduced staff costs and lower scientific consulting and IP costs, partly offset by restructuring charges. General and administrative expenses were EUR 19.4 million, broadly stable year over year, with lower non-scientific consulting fees and insurance costs partially offset by restructuring impacts.
Innate ended 2025 with EUR 44.8 million in cash equivalents and financial assets and said, based on its current operating plan, this provides funding visibility until the end of the third quarter of 2026.
About Innate Pharma (NASDAQ:IPHA)
Innate Pharma SA is a clinical-stage biotechnology company specializing in the discovery and development of antibody-based therapies that harness the body’s innate immune system to combat cancer. Founded in 1999 and headquartered in Marseille, France, the company pioneers novel monoclonal antibodies designed to activate natural killer cells and macrophages, offering a complementary approach to existing immuno-oncology treatments.
The company’s lead program, monalizumab, targets the NKG2A immune checkpoint receptor and is being developed in collaboration with AstraZeneca.
