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ASX/Media Release Immutep Quarterly Activities Report & Appendix 4C Q4 FY25 The pivotal TACTI-004 Phase III trial in first line non-small cell lung cancer (1L NSCLC) continues to build momentum and is recruiting patients

Key Takeaway: Immutep Limited has released its quarterly activities report for Q4 FY25, highlighting significant progress in its pivotal TACTI-004 Phase III trial for first-line non-small cell lung cancer (1L NSCLC). The trial, evaluating efti in combination with KEYTRUDA and chemotherapy, is building momentum with 78 clinical sites approved across 23 countries. The company reported positive initial data from its Phase I trial of IMP761 for autoimmune diseases and a robust cash balance of approximately A$129.69 million. However, an increase in net cash used for research and development activities has raised some concerns regarding operational expenditures.

Market Sentiment Analysis

POSITIVE FACTORS

  • Momentum in the TACTI-004 Phase III trial with increased patient recruitment.
  • Encouraging preliminary efficacy and safety data from ongoing trials.
  • Positive financial standing with a strong cash balance to support clinical programs.
  • Successful patient dosing marks progress in non-small cell lung cancer trials.

CONCERNS & RISKS

  • Increased net cash used in R&D activities, indicating high expenditure.
  • Limited revenue generation from cash receipts (A$6k) raises concerns about sustainability.

Full Press Release Details

Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 30 July 2025 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 30 June 2025 (Q4 FY25).
EFTI DEVELOPMENT PROGRAM IN ONCOLOGY
TACTI-004 (KEYNOTE-F91) Ongoing Phase III Trial in 1L NSCLC
Immutep s pivotal TACTI-004 Phase III trial is on track and continues to build momentum and is recruiting patients
at a growing number of activated clinical sites and countries, with now 78 sites and 23 countries having received regulatory approval, following the successful dosing of the first patient at Calvary Mater Newcastle Hospital in Australia in March
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 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.
In late May, Immutep presented a
Trial-in-Progress poster for TACTI-004 at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in the United
States. We have observed encouraging support from the investigators participating in the study in our meetings to date including those held at ASCO 2025, ELCC 2025, and an investigator meeting in Budapest, Hungary. Consistent feedback has been that
the efficacy and the 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
INSIGHT-003 Phase I Trial in Non-Squamous 1L NSCLC
In May, Immutep announced a high 60.8% response rate and 90.2% disease control rate (N=51), according to RECIST1.1, had been achieved in the
investigator-initiated INSIGHT-003 trial as of the data cut-off date of 6 May 2025. INSIGHT-003 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 non-small cell lung cancer (1L NSCLC).
In patients with TPS <50% (N=47), who represent a high unmet need and over two-thirds of the 1L NSCLC population,
the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8% from KEYTRUDA and
chemotherapy.3 Safety continues to be favourable with no new safety signals. Data from this trial are expected to be presented at a medical conference later in CY2025.
HEAD AND NECK CANCER
TACTI-003 (KEYNOTE-C34) Cohort B Phase IIb Trial in 1L HNSCC with CPS <1
In May, Immutep announced an excellent median Overall Survival (OS) of 17.6 months had been achieved in Cohort B of the
TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the Phase II study evaluates efti in combination with
KEYTRUDA as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below one
(Combined Positive Score [CPS] <1).
The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches in the United
States for 1L HNSCC patients with CPS <1 including 10.7-months from cetuximab + chemotherapy and 11.3-months from anti-PD-1 therapy + chemotherapy, as well as 7.9-months from anti-PD-1 monotherapy.1,2
Immutep requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps
including potential paths to approval for 1L HNSCC with PD-L1 CPS <1.
EFTISARC-NEO Phase II Trial in Soft Tissue Sarcoma
In May, Immutep announced the investigator-initiated EFTISARC-NEO Phase II trial evaluating efti with radiotherapy plus
KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study s prespecified median of
35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable STS.
The EFTISARC-NEO study is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program.
The trial s investigators at the Maria Sk odowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre
for STS in Poland, plan to present results from the study at a medical meeting later in CY2025.
AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer
Immutep is continuing 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 later in CY2025.
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.
In June, Immutep announced positive initial efficacy data and continued favourable safety data from the first-in-human Phase I study. Through the highest dosing level of IMP761 to date (0.9 mg/kg), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at
this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating
autoimmune diseases.
Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. Additional data from the Phase I is expected to
follow later in CY 2025.
INTELLECTUAL PROPERTY
During the quarter, Immutep was granted four new patents. Immutep was granted two new patents for efti in combination with a
PD-1 pathway inhibitor by the New Zealand Intellectual Property Office. In addition, two new patents were granted for IMP761, one by the Intellectual Property Office of the Philippines and the other by the
Korean Intellectual Property Office.
CORPORATE & FINANCIAL SUMMARY
Senior Management Changes
Immutep s Acting Chief
Medical Officer, Stephan Winckels M.D, Ph.D., has been appointed to the permanent position of Chief Medical Officer. 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.
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 June 2025 of approximately A$129.69 million,
which is greater than budgeted as at the beginning of FY2025, while progressing our clinical programs within announced timeframes. The total balance consists of: 1) a cash and cash equivalent balance of A$67.41 million and 2) bank term deposits
totalling A$62.28 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.
In Q4 FY25, cash receipts from customers were A$6k. The net cash used in G&A activities in the quarter was A$1.44 million, compared to A$704k in Q3
FY25. Payments to Related Parties (detailed in item 6.1 of the Appendix 4C) comprises Non-Executive Directors fees and Executive Directors remuneration of A$307k.
The net cash used in R&D activities during the quarter was A$15.66 million, compared to A$13.6 million in Q3 FY25. The increase is in line with
increased clinical trial activities.
Payment for staff costs was A$2.5 million in the quarter, the same as for Q3 FY25. Total net cash outflows used
in operating activities in the quarter were A$18.92 million compared to A$16.26 million in Q3 FY25.
Total cash outflows used in investing
activities for the quarter was A$8.16 million, mainly due to the net increase 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$12.92 million from short-term investments that had matured to cash at bank and invested A$21.05 million in short-term investments.
In July, US-based Ridgeback Capital Investments L.P. exercised its
last remaining convertible notes and warrants in the Company. The cashless exercise resulted in the issuance of 7,475,208 ordinary shares. The Company is now free of any convertible debt, warrants or options.
A copy of the Appendix 4C - Quarterly Cash Flow Report for the quarter is attached.
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:
+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
This announcement was authorised for release by the CEO of Immutep Limited
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia
cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
Immutep Limited
ABN Quarter ended ( current quarter )
90 009 237 889 30 th June 2025
Consolidated statement of cash flows Current quarter $A 000 Year to date (12 months) $A 000
1. Cash flows from operating activities
1.1 Receipts from customers 6 46
1.2 Payments for
(a) research and development (15,664 ) (54,950 )
(b) product manufacturing and operating costs
(c) advertising and marketing (32 ) (172 )
(d) leased assets
(e) staff costs (2,501 ) (10,240 )
(f) administration and corporate costs (1,444 ) (3,675 )
1.3 Dividends received (see note 3)
1.4 Interest received 905 3,716
1.5 Interest and other costs of finance paid (13 ) (38 )
1.6 Income taxes paid
1.7 Government grants and tax incentives 4 4,156
1.8 Other (provide details if material) -Intellectual property management (183 ) (1,581 )
1.9 Net cash from / (used in) operating activities (18,922 ) (62,738 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities
(b) businesses
(c) property, plant and equipment (33 ) (44 )
(d) investments (21,047 ) (88,786 )
Consolidated statement of cash flows Current quarter $A 000 Year to date (12 months) $A 000
(e) intellectual property (276 )
(f) other non-current assets
2.2 Proceedsfrom disposal of:
(a) entities
(b) businesses
(c) property, plant and equipment
(d) investments 12,916 50,524
(e) intellectual property
(f) other non-current assets
2.3 Cashflows from loans to other entities
2.4 Dividendsreceived (see note 3)
2.5 Other(provide details if material)
2.6 Net cash from / (used in) investing activities (8,164 ) (38,582 )
3. Cash flows from financing activities
3.1 Proceeds from issues of equity securities (excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt securities
3.3 Proceeds from exercise of options
3.4 Transaction costs related to issues of equity securities or convertible debt securities (254 )
3.5 Proceeds from borrowings
3.6 Repayment of borrowings
3.7 Transaction costs related to loans and borrowings
3.8 Dividends paid
3.9 Other (provide details if material) (71 ) (309 )
3.10 Net cash from / (used in) financing activities (71 ) (563 )
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 92,451 161,790
4.2 Net cash from / (used in) operating activities (item 1.9 above) (18,922 ) (62,738 )
Consolidated statement of cash flows Current quarter $A 000 Year to date (12 months) $A 000
4.3 Net cash from / (used in) investing activities (item 2.6 above) (8,164 ) (38,582 )
4.4 Net cash from / (used in) financing activities (item 3.10 above) (71 ) (563 )
4.5 Effect of movement in exchange rates on cash held 2,114 7,501
4.6 Cash and cash equivalents at end of period 67,408 67,408
5. Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts Current quarter $A 000 Previous quarter $A 000
5.1 Bank balances 45,364 22,141
5.2 Call deposits 4,786 7,181
5.3 Bank overdrafts
5.4 Other (provide details if material) -Term deposit 17,258 63,129
5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) 67,408 92,451
6. Payments to related parties of the entity and their associates Current quarter $A 000
6.1 Aggregate amount of payments to related parties and their associates included in item 1 307
6.2 Aggregate amount of payments to related parties and their associates included in item 2
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments.
The amount at 6.1 includes payment of Non-Executive Directors fees and Executive Directors remuneration.

Frequently Asked Questions

What is the TACTI-004 trial evaluating?

TACTI-004 assesses eftilagimod alfa with KEYTRUDA and chemotherapy for NSCLC.

What was the response rate in INSIGHT-003 trial?

The INSIGHT-003 trial demonstrated a 60.8% response rate in patients treated.

What is the median overall survival in TACTI-003 trial?

Cohort B of TACTI-003 achieved a median overall survival of 17.6 months.

What is the status of IMP761's Phase I trial?

IMP761's Phase I trial is ongoing with promising initial efficacy and safety data.

How many patents did Immutep receive recently?

Immutep was granted four new patents during the quarter for its therapies.

Last updated: Jul 31, 2025