-- Lacutamab TELLOMAK-3 confirmatory Phase 3 trial in cutaneous T-cell
lymphoma (CTCL) remains planned for initiation in H2 2026, subject to
non-dilutive financing options currently under negotiation, including
pharma partnering and royalty structures
-- IPH4502 (Nectin-4 ADC) continues to show preliminary anti-tumor
activity with favorable safety profile to date; the maximum tolerated
dose has been reached and enrollment in the Phase 1 dose escalation and
cohort enrichment is nearing completion
-- PACIFIC-9 Phase 3 trial, which includes monalizumab and is led by
AstraZeneca, continues to advance toward a planned H2 2026 data readout
-- IPH5201 (anti-CD39 antibody), developed in collaboration with
AstraZeneca, showed encouraging early results presented in a Clinical
Trials Plenary Session at AACR 2026, supporting continued investigation
in the MATISSE Phase 2 study in non-small cell lung cancer (NSCLC)
-- Cash position of EUR25.4 million1 as of March 31, 2026, with an
anticipated cash runway until the end of Q3 2026
-- Conference call to be held today at 1:30 p.m. CEST / 7:30 a.m. EDT
MARSEILLE, France--(BUSINESS WIRE)--May 13, 2026--
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today reported its business update and consolidated financial results for the quarter ending March 31, 2026.
"We have continued to make solid progress across our priority clinical assets during the first quarter. We are approaching completion of enrollment in the Phase 1 dose escalation and backfill cohorts for IPH4502. In parallel, we have advanced the negotiations for non-dilutive financing options to allow initiation of the lacutamab confirmatory Phase 3 TELLOMAK-3 trial in CTCL. Finally, the Phase 3 PACIFIC-9 trial with AstraZeneca is planned for data readout in the second half of 2026. Separately, we were pleased to see encouraging results from the MATISSE Phase 2 trial presented at the AACR Annual Meeting 2026. It is exciting to see the continued advancement of our differentiated immunotherapy pipeline for patients with high unmet medical need," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.
Webcast and conference call will be held today at 1:30 p.m. CEST (7:30 a.m.
EDT) Click here to access the live webcast. Analysts may also join via
telephone to ask questions, click here to register. This information can also
be found on the Investors section of the Innate Pharma website,
www.innate-pharma.com. A replay of the webcast will be available on the
Company's website for 90 days following the event.
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(1) Including short term investments (EUR4.9m) and non-current financial
instruments (EUR10.4m).
Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
Cutaneous T-Cell Lymphoma
-- The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label,
multi-center, randomized, comparative study evaluating lacutamab in
patients with Sézary syndrome and mycosis fungoides, who have failed
at least one prior systemic therapy.
-- TELLOMAK-3 includes two cohorts: a confirmatory cohort in
Sézary syndrome, intended to support a potential accelerated
approval based on existing TELLOMAK Phase 2 data, and a
registrational cohort in mycosis fungoides, intended to support
full approval. The primary endpoint of the study for both cohorts
is progression-free survival $(PFS)$ evaluated by blinded central
review.
-- Following the U.S. Food and Drug Administration (FDA) review of
the Phase 3 protocol, with no further comments in November 2025,
the trial is planned for initiation in H2 2026.
-- The FDA provided encouraging feedback on the TELLOMAK Phase 2 results
and the proposed regulatory pathway, which may support an accelerated
approval in Sézary syndrome once the Phase 3 trial is underway. In
February 2025, the FDA granted Breakthrough Therapy Designation to
lacutamab for relapsed or refractory Sézary syndrome.
-- The TELLOMAK Phase 2 trial is completed, and patients still on
treatment at the end of the study continue to receive lacutamab through a
Post Trial Access program.
-- An abstract authored by ZS Associates entitled "Cutaneous T-Cell
Lymphoma Epidemiology in the United States: A Real-World Data Analysis of
Administrative Claims" has been accepted for publication in the official
Abstract Book of the European Hematology Association Congress 2026. The
analysis, sponsored by Innate, reports approximately 12,400 prevalent
patients with mycosis fungoides (MF) and 1,100 with Sézary syndrome
(SS), with 2,900 and 300 new cases per year, respectively.
Peripheral T-Cell Lymphoma (PTCL)
-- KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an
investigator-sponsored, randomized study led by the Lymphoma Study
Association (LYSA) evaluating lacutamab in combination with GEMOX
(gemcitabine and oxaliplatin) versus GEMOX alone in patients with
KIR3DL2-expressing relapsed/refractory PTCL, is ongoing.
IPH4502 (Nectin-4 exatecan ADC):
-- The IPH4502-101 Phase 1 study (NCT06781983), recruiting in France and
in the United States, is evaluating the safety, tolerability, and
preliminary anti-tumor activity of IPH4502 in advanced solid tumors known
to express Nectin-4, including but not limited to urothelial carcinoma,
non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal
cancers.
-- The maximum tolerated dose has been reached and enrollment in the Phase
1 dose escalation and cohort enrichment is nearing completion.
Preliminary anti-tumor activity continues to be observed in heavily
pre-treated patients with advanced solid tumors, including in patients
with urothelial cancer relapsed or refractory to enfortumab vedotin, with
a favorable safety profile to date.
Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca:
-- The PACIFIC-9 Phase 3 trial run by AstraZeneca evaluating durvalumab
(anti-PD--L1) in combination with monalizumab or AstraZeneca's oleclumab
(anti-CD73) in patients with unresectable, Stage III non-small cell lung
cancer (NSCLC) who have not progressed following platinum-based
chemoradiation therapy $(CRT)$ is ongoing. Enrollment in the trial is
complete, and data readout is expected in H2 2026.
Other Clinical stage assets
IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca): The MATISSE Phase 2 trial is evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in the neoadjuvant lung cancer setting.
-- Interim results from MATISSE Phase 2 were presented in a Clinical
Trials Plenary Session at the AACR Annual Meeting 2026 on April 21, 2026
in San Diego, by Pr. Fabrice Barlesi (Institut Gustave Roussy). The
pre-planned interim analysis was conducted on 40 patients with resectable
early-stage (stage II--IIIA) NSCLC treated with perioperative IPH5201 in
combination with durvalumab and platinum-based chemotherapy. The
combination showed encouraging results with overall pathological complete
response (pCR) rate of 27.5% (95% CI: 14.6--43.9). pCR rates were notably
higher in patients with PD-L1-positive tumors, reaching 35.7% in PD-L1
>=1% patients (n=28%) and 50.0% in PD--L1 >=50% patients (n=14). Higher
baseline tumor CD39+ and CD8+ cell density was observed in patients
achieving pCR/mPR, suggesting CD39 expression as a potentially emerging
biomarker. The safety profile was comparable to that of preoperative
platinum-based chemotherapy with durvalumab. Based on these encouraging
results, the MATISSE study continues enrollment in the PD-L1 >=1% patient
population.
IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.
IPH6101 (ANKET$(R)$ anti-CD123, proprietary): Innate has initiated a research collaboration to further assess next steps of development.
IPH6401/SAR'514 (ANKET(R) anti-BCMA, partnered with Sanofi): During the first quarter, Sanofi announced deprioritization of SAR'514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged.
Corporate Update:
-- As previously announced, in line with its strategic focus, the Company
has streamlined its organization. Planned layoffs were implemented
through a redundancy plan which is completed.
-- As of March 31, 2026, the balance available under our April 2023 sales
agreement under the At-The-Market program remains at $75 million.
Financial highlights for Q1 2026:
Cash, cash equivalents and financial assets of the Company amounted to EUR25.4 million as of March 31, 2026. At the same date, financial liabilities amounted to EUR20.3 million.
Revenue for the three-month period ending March 31, 2026, amounted to EUR2.6 million (EUR1.2 million for the same period in 2025). Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.
About Innate Pharma:
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