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

Insights

Biotech Investment Analyst

Immutep reaches critical Phase III milestone in lung cancer while maintaining strong cash runway through 2026, positioning for potentially transformative data readouts.

Immutep's Q3 FY25 update demonstrates significant advancement in their clinical development pipeline, most notably with the first patient dosed in their pivotal TACTI-004 Phase III trial. This represents a critical milestone that substantially derisks their development path for eftilagimod alfa (efti) in non-small cell lung cancer, one of oncology's largest market opportunities as explicitly noted in the report.

The Phase III trial's scope is substantial, involving 756 patients across more than 150 clinical sites with regulatory approvals expanded to 19 countries. This global footprint accelerates enrollment potential and broadens future commercial possibilities if successful.

Equally important is the completion of patient enrollment in both the EFTISARC-NEO Phase II and INSIGHT-003 Phase I trials. These completed enrollments transition these studies to the data generation and analysis phase, creating near-term catalysts with updates expected in CY2025.

The company continues following patients in the TACTI-003 trial for head and neck cancer, with plans to engage regulators by mid-year regarding potential paths forward. This suggests the data to date has shown sufficient promise to warrant regulatory discussions.

Their intellectual property position was strengthened with two new patents for LAG525 and a Russian patent for an IMP761 assay, enhancing their competitive positioning in the emerging LAG-3 therapeutic landscape.

This clinical progress establishes Immutep as advancing meaningfully in multiple oncology indications with their first-in-class MHC Class II agonist, creating multiple shots on goal with their lead asset.

Financial Analyst

Immutep maintains exceptional financial discipline with A$146.25M cash position providing runway through 2026 despite advancing Phase III program.

Immutep's financial position reveals remarkable fiscal management for a clinical-stage biotech advancing to pivotal studies. The company reports A$146.25 million in cash and equivalents as of March 31, 2025, explicitly exceeding their budgeted expectations for this point in the fiscal year while simultaneously delivering on announced clinical milestones.

This cash position, comprising A$92.45 million in cash and A$53.80 million in bank term deposits, provides runway through the end of CY2026. For a biotech company advancing a Phase III program, this extended runway significantly reduces financing risk through multiple potential data catalysts.

The quarter demonstrated improved operational efficiency with R&D expenditures decreasing to A$13.6 million from A$16.2 million in the previous quarter. This reduction stems from study enrollment completions and previous prepayment of TACTI-004 "kick-off costs" rather than program cuts. Total operating cash outflows decreased to A$16.26 million from A$19.0 million quarter-over-quarter.

While G&A expenses increased modestly to A$704k from A$566k in Q2 FY25, this marginal increase is insignificant relative to the overall cash position and operational scale.

The company's cash management strategy appears highly effective—maintaining substantial reserves while simultaneously advancing multiple clinical programs including a global Phase III trial. This balance of clinical progression and fiscal discipline is particularly impressive for a development-stage biotech company.

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$146.25 million, which is greater than budgeted as at the beginning of the current financial year, whilst delivering on our announced goals. The total balance consists of: 1) a cash and cash equivalent balance of A$92.45 million and 2) bank term deposits totaling A$53.80 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q3 FY25, cash receipts from customers were A$12k. The net cash used in G&A activities in the quarter was A$704k, compared to A$566k in Q2 FY25. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$363k.

The net cash used in R&D activities during the quarter was A$13.6 million, compared to A$16.2 million in Q2 FY25. The decrease is mainly due to:

• 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$2.5 million in the quarter, which was the same as for Q2 FY25.

Total net cash outflows used in operating activities in the quarter were A$16.26 million compared to A$19.0 million in Q2 FY25.

Total cash inflow from investing activities for the quarter was A$32.34 million, mainly due to the maturity of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the company transferred back A$32.34 million from short-term investments that had matured to cash at bank, resulting in a positive cashflow in investing activities.

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?

Immutep (IMMP) reported a strong cash position of A$146.25 million as of March 31, 2025, consisting of A$92.45 million in cash and cash equivalents, plus A$53.80 million in bank term deposits. This provides an expected cash reach until the end of 2026.

How many patients will be enrolled in IMMP's TACTI-004 Phase III lung cancer trial?

The TACTI-004 Phase III trial will randomize approximately 756 patients across more than 150 clinical sites, evaluating efti in combination with KEYTRUDA and chemotherapy for first-line treatment of advanced non-small cell lung cancer.

Which clinical trials did Immutep (IMMP) complete enrollment for in Q1 2025?

In January 2025, Immutep completed patient enrollment for two trials: the INSIGHT-003 Phase I trial with approximately 50 evaluable patients, and the EFTISARC-NEO Phase II trial with 40 patients.

How many countries has IMMP's TACTI-004 trial been approved in?

IMMP's TACTI-004 trial has received regulatory approvals in 19 countries, including Australia, Austria, Belgium, Bulgaria, Canada, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Lithuania, Portugal, Spain, and the United Kingdom.

What was Immutep's (IMMP) R&D spending in Q3 FY25?

Immutep's net cash used in R&D activities during Q3 FY25 was A$13.6 million, down from A$16.2 million in Q2 FY25, primarily due to completed enrollment in several trials and reduced trial-related costs.