Immutep Quarterly Activities Report Q1 FY26
Rhea-AI Summary
Immutep (NASDAQ: IMMP / ASX: IMM) reported Q1 FY26 progress on clinical programs and finances on 29 Oct 2025. Key oncology highlights: the pivotal TACTI-004 Phase III in 1L NSCLC now has >170 patients enrolled (trial randomises ~756), >100 sites open across 24 countries and a futility analysis on track for Q1 CY2026. FDA gave constructive feedback on late‑stage development of efti in 1L HNSCC CPS<1, including registrational or single‑arm paths (≈70–90 patients).
Other updates: INSIGHT‑003 and EFTISARC‑NEO data presented at ESMO 2025, new investigator‑initiated neoadjuvant breast trial, IMP761 Phase I data due Q4 CY2025, four new patents granted, and CMO appointment effective 1 Jul 2025. Cash and term deposits total A$109.85M, supporting operations into end of CY2026.
Positive
- Cash and term deposits of A$109.85M
- TACTI‑004 enrolled >170 patients, passing futility threshold
- >100 clinical sites open across 24 countries for TACTI‑004
- EFTISARC‑NEO met primary endpoint; tumour hyalinization exceeded prespecified median
Negative
- Quarterly operating cash outflow of A$19.04M
- R&D cash use of A$15.83M in Q1 FY26, increasing near-term burn
News Market Reaction 1 Alert
On the day this news was published, IMMP declined 1.01%, reflecting a mild negative market reaction. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $283M at that time.
Data tracked by StockTitan Argus on the day of publication.
Media Release
- Pivotal TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in first line non-small cell lung cancer continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries
- Trial in Progress poster for TACTI-004 presented at the World Conference on Lung Cancer (WCLC) 2025, where physician feedback continued to be encouraging
- Positive feedback received from the FDA regarding future late-stage clinical development of efti in first line head and neck cancer patients with PD-L1 expression below 1 (CPS <1)
- New investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients
- Three abstracts for clinical trials evaluating efti were accepted and presented at the European Society for Medical Oncology (ESMO) Congress 2025
- Strong cash, cash equivalent and term deposit position of A
$109.85 million , providing an expected cash reach to the end of CY2026
SYDNEY, AUSTRALIA, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune disease, provides an update on its activities for the quarter ended 30 September 2025 (Q1 FY26).
EFTI DEVELOPMENT PROGRAM IN ONCOLOGY
LUNG CANCER
TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC
Immutep’s pivotal TACTI-004 (KEYNOTE-F91) Phase III trial continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries. There are now over 100 clinical sites open for enrollment and 24 countries that have received regulatory approval.
The TACTI-004 trial evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® and chemotherapy as first line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomise approximately 756 patients at more than 150 clinical sites and trial results will inform a potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology.
In July, Immutep announced that a Trials in Progress ePoster had been accepted at the European Society for Medical Oncology (ESMO) Congress 2025 which took place 17- 21 October in Berlin, Germany.
In September, Immutep presented a Trial in Progress poster presentation for TACTI-004 at the IASLC 2025 World Conference on Lung Cancer (WCLC), in Barcelona, Spain, where physician feedback continued to be encouraging. The Trial in Progress poster included an overview and study design of the trial.
Subsequent to the end of the quarter, the Company announced in October that this global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysis, which remains on track for completion in the first quarter of CY2026.
INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
In July, Immutep announced that data from the INSIGHT-003 Phase I investigator-initiated trial in 1L NSCLC had been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 which took place 17- 21 October in Berlin, Germany.
The multi-centre INSIGHT-003 study is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA® and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous 1L NSCLC. This is the same immunotherapy/chemotherapy combination being used in the pivotal TACTI-004 Phase III in 1L NSCLC.
Encouraging data from this trial has been presented at ESMO 2025.
HEAD AND NECK CANCER
TACTI-003 (KEYNOTE-C34) Cohort B – Phase IIb Trial in 1L HNSCC with CPS <1
In August, Immutep received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future late-stage clinical development of efti in first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1.
Based on its review of the encouraging data in 1L HNSCC with CPS <1 from TACTI-003 (KEYNOTE-C34), the FDA agreed on the potential of efti in combination with KEYTRUDA® to address the high unmet need in this CPS <1 patient segment and is supportive of the combination’s further development.
Paths for future clinical development and potential accelerated approval in light of the FDA’s Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA® against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 – 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data.
SOFT TISSUE SARCOMA
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
In July, Immutep announced that an abstract for the EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA® in the neoadjuvant setting for resectable soft tissue sarcoma (STS) had been accepted as a Proffered Paper oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025 which took place 17- 21 October in Berlin, Germany.
Additionally, in September, Immutep announced that an abstract for the EFTISARC-NEO Phase II trial had been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida, USA.
As previously announced, the investigator-initiated EFTISARC-NEO Phase II trial has met its primary endpoint. The novel combination significantly exceeded the study’s prespecified median of
Encouraging data from this trial has been presented at ESMO 2025.
BREAST CANCER
AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer
Immutep continues to execute the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors.
Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA.
Patient follow up, data cleaning and analysis is ongoing, and an update will be provided at the San Antonio Breast Cancer Symposium in San Antonio, Texas, USA in December 2025.
New Investigator-Initiated Phase II trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer
In September, the Company announced the launch of an investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients. The trial, led by Dr. Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at The George Washington (GW) University Cancer Center, aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC).
The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
IMP761 – Phase I Trial
Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.
Following previously reported positive initial efficacy data and continued favourable safety data from the first-in-human Phase I study in June, additional data from the Phase I study is expected to follow in Q4 CY2025.
INTELLECTUAL PROPERTY
During the quarter, Immutep was granted four new patents.
The Israel and New Zealand Patent Office each granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein used in characterisation of efti in GMP-grade manufacturing.
A new patent was also granted for IMP761 in New Zealand. For LAG525, which is exclusively licensed to Novartis by Immutep, a new patent was granted in Taiwan.
CORPORATE & FINANCIAL SUMMARY
Senior Management Changes
As previously reported Stephan Winckels M.D, Ph.D., has been appointed to the permanent position of Chief Medical Officer effective 1 July 2025. Stephan has over 15 years of experience in oncology drug development and has been working on efti trials as Medical Monitor or Data Monitoring Committee member for more than nine years.
Cash Flow Summary
During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761.
The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 30 September 2025 of approximately A
In Q1 FY26, cash receipts from customers were A
The net cash used in R&D activities during the quarter was A
Payment for staff costs was A
Total cash inflow from investing activities for the quarter was A
About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co
+61 (0)400 886 722; eleanor.pearson@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
How many patients has Immutep (IMMP) enrolled in the TACTI‑004 Phase III trial as of Oct 29, 2025?
What cash runway does Immutep (IMMP) report after Q1 FY26?
When is the TACTI‑004 futility analysis expected for Immutep's (IMMP) Phase III NSCLC trial?
What regulatory feedback did Immutep (IMMP) receive from the FDA for efti in head and neck cancer on Oct 29, 2025?
What clinical data readouts from Immutep (IMMP) are expected in late 2025?
Did Immutep (IMMP) report any patent grants in Q1 FY26?
