Immutep Quarterly Activities Report Q3 FY25
Rhea-AI Summary
Immutep has reached significant milestones in Q3 FY25, with the first patient dosed in their pivotal TACTI-004 Phase III lung cancer trial. This global trial will evaluate eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy for non-small cell lung cancer treatment, targeting 756 patients across 150+ clinical sites.
The company completed patient enrollment in two key trials: the EFTISARC-NEO Phase II trial for soft tissue sarcoma and the INSIGHT-003 Phase I trial for NSCLC treatment. Immutep maintains a strong financial position with A$146.25 million in cash, providing runway through end of CY2026.
Key financial highlights for Q3 FY25:
- R&D expenses decreased to A$13.6 million from A$16.2 million in Q2
- G&A costs were A$704k
- Staff costs remained stable at A$2.5 million
- Total operating cash outflow was A$16.26 million
Positive
- Strong cash position of A$146.25M with expected reach until end of 2026
- First patient dosed in pivotal Phase III TACTI-004 trial for lung cancer
- Completed enrollment in multiple clinical trials: EFTISARC-NEO and INSIGHT-003
- Expanded regulatory approvals to 19 countries for TACTI-004 trial
- Lower burn rate due to completion of several trial enrollments
- Two new patents granted for LAG525 in Philippines and United States
Negative
- Net cash used in R&D activities was A$13.6M for the quarter
- Increased G&A expenses to A$704k compared to A$566k in previous quarter
News Market Reaction
On the day this news was published, IMMP gained 4.85%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Media Release
- First patient safely dosed in TACTI-004 Phase III lung cancer trial, marking a significant milestone
- Pivotal TACTI-004 trial design presented at the European Lung Cancer Congress (ELCC) 2025
- Patient enrolment completed for the EFTISARC-NEO Phase II trial evaluating efti with radiotherapy and KEYTRUDA® in resectable soft tissue sarcoma
- Patient enrolment completed for the INSIGHT-003 Phase I trial evaluating efti with KEYTRUDA® and chemotherapy as first-line treatment of advanced or metastatic 1L NSCLC
- Strong cash position of A
$146.25 million , providing an expected cash reach to the end of CY2026
SYDNEY, AUSTRALIA, April 29, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 31 March 2025 (Q3 FY25).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 – First Patient Successfully Dosed in Pivotal Phase III Trial in 1L NSCLC
In March 2025, Immutep announced the first patient in the Company’s pivotal TACTI-004 Phase III trial was successfully dosed at Calvary Mater Newcastle Hospital in Australia. TACTI-004 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® (pembrolizumab) and chemotherapy as first line treatment of patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomize 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.
Immutep also presented the pivotal TACTI-004 Phase III trial as a Trial-in-Progress poster at the European Lung Cancer Congress (ELCC) 2025, in Paris, France, in late March. The poster included an overview and study design of the TACTI-004 Phase III trial. Informed by the Company’s AIPAC-003 study, Immutep has determined to move forward with 30 mg efti dosing as the optimal biological dose. We have observed encouraging support from the investigators participating in the study in our meetings to date including those held at ELCC 2025 and after quarter end at the investigator meeting in Budapest, Hungary. Consistent feedback has been that the efficacy and safety data collected thus far from the TACTI-002 and INSIGHT-003 trials are impressive and address the unmet medical needs seen by many key opinion leaders.
Recruitment in TACTI-004 is underway at a growing number of activated clinical sites and countries with approvals from regulatory authorities expanded to now 19 countries including Australia, Austria, Belgium, Bulgaria, Canada, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Lithuania, Portugal, Spain, and the United Kingdom.
TACTI-003 (KEYNOTE-C34) – Phase IIb Trial in 1L HNSCC
Immutep continued to follow patients in the TACTI-003 (KEYNOTE-C34) Phase IIb trial, which is evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC), during Q3 FY25. Immutep most recently reported positive results from Cohort B of the trial in 1L HNSCC patients with PD-L1 negative tumours (CPS <1) who typically do not respond well to anti-PD-1 therapy alone, at the ESMO Immuno-Oncology Annual Congress in December 2024. Immutep will continue to follow the maturing data from TACTI-003 and plans to engage with regulatory authorities regarding potential paths forward by mid of this year.
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 30mg or 90mg 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 is anticipated in CY2025.
INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
In January 2025, Immutep announced that patient enrolment has been completed for the ongoing investigator-initiated INSIGHT-003 trial. INSIGHT-003 is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first line treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). The Phase I trial has reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF.
Positive first Overall Survival results and other data points from INSIGHT-003 were reported in late 2024. Data updates from INSIGHT-003 are expected in CY2025.
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
In January 2025, Immutep announced that patient enrolment has been completed in the ongoing investigator-initiated EFTISARC-NEO trial. EFTISARC-NEO is evaluating efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS). The Phase II trial being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, reached its enrolment target of 40 patients.
Encouraging data from EFTISARC-NEO was presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024. Data updates from EFTISARC-NEO are expected in CY2025.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class agonist LAG-3 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 favourable initial safety data in December 2024, additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships are expected to be reported in CY2025.
INTELLECTUAL PROPERTY
During the quarter, Immutep was granted two new patents for LAG525 in in the Philippines and the United States. Immutep was also granted a Russian patent directed to an assay for use in measuring the potency of IMP761, for example, as part of a quality control step in production of the agonist LAG-3 antibody.
CASH FLOW SUMMARY
During the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761 with prudent cash management. The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 31 March 2025 of approximately A
In Q3 FY25, cash receipts from customers were A
The net cash used in R&D activities during the quarter was A
- the prepayment of TACTI-004 clinical trial related “kick-off costs” to initiate the trial in the previous quarter; and
- the completion of enrolment in the Phase II portion of the AIPAC-003 trial and the cost-efficient investigator initiated EFTISARC-NEO and INSIGHT-003 trials, which like TACTI-003 are all now focused on patient follow up. As such the Company is incurring significantly lower burn rates from those trials.
Payment for staff costs was A
Total net cash outflows used in operating activities in the quarter were A
Total cash inflow from investing activities for the quarter was A
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique 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:
Catherine Strong, Sodali & Co
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
What is the cash position of Immutep (IMMP) as of March 2025?
How many patients will be enrolled in IMMP's TACTI-004 Phase III lung cancer trial?
Which clinical trials did Immutep (IMMP) complete enrollment for in Q1 2025?
How many countries has IMMP's TACTI-004 trial been approved in?
What was Immutep's (IMMP) R&D spending in Q3 FY25?
