Full Press Release Details
Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 29 April 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 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.
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 Sk odowska-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.
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 (detailed in item 6.1 of the Appendix 4C) 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:
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.
A copy of the Appendix 4C -
Quarterly Cash Flow Report for the quarter is attached.
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
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
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 | 31st March 2025 |
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (9 months) $A 000 | ||||||
| 1. Cash flows from operating activities | ||||||||
| 1.1 Receipts from customers | 12 | 40 | ||||||
| 1.2 Payments for | ||||||||
| (a) research and development | (13,592 | ) | (39,286 | ) | ||||
| (b) product manufacturing and operating costs | ||||||||
| (c) advertising and marketing | (31 | ) | (140 | ) | ||||
| (d) leased assets | ||||||||
| (e) staff costs | (2,500 | ) | (7,739 | ) | ||||
| (f) administration and corporate costs | (704 | ) | (2,231 | ) | ||||
| 1.3 Dividends received (see note 3) | ||||||||
| 1.4 Interest received | 810 | 2,811 | ||||||
| 1.5 Interest and other costs of finance paid | (8 | ) | (25 | ) | ||||
| 1.6 Income taxes paid | ||||||||
| 1.7 Government grants and tax incentives | 4,152 | |||||||
| 1.8 Other (provide details if material) -Intellectual property management | (249 | ) | (1,398 | ) | ||||
| 1.9 Net cash from / (used in) operating activities | (16,262 | ) | (43,816 | ) | ||||
| 2. Cash flows from investing activities | ||||||||
| 2.1 Payments to acquire or for: | ||||||||
| (a) entities | ||||||||
| (b) businesses | ||||||||
| (c) property, plant and equipment | (11 | ) | ||||||
| (d) investments | (67,739 | ) |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (9 months) $A 000 | ||||||
| (e) intellectual property | (276 | ) | ||||||
| (f) other non-current assets | ||||||||
| 2.2 Proceeds from disposal of: | ||||||||
| (a) entities | ||||||||
| (b) businesses | ||||||||
| (c) property, plant and equipment | ||||||||
| (d) investments | 32,342 | 37,608 | ||||||
| (e) intellectual property | ||||||||
| (f) other non-current assets | ||||||||
| 2.3 Cash flows from loans to other entities | ||||||||
| 2.4 Dividends received (see note 3) | ||||||||
| 2.5 Other (provide details if material) | ||||||||
| 2.6 Net cash from / (used in) investing activities | 32,342 | (30,418 | ) | |||||
| 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) | (65 | ) | (238 | ) | ||||
| 3.10 Net cash from / (used in) financing activities | (65 | ) | (492 | ) |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (9 months) $A 000 | ||||||
| 4. Net increase / (decrease) in cash and cash equivalents for the period | ||||||||
| 4.1 Cash and cash equivalents at beginning of period | 73,887 | 161,790 | ||||||
| 4.2 Net cash from / (used in) operating activities (item 1.9 above) | (16,262 | ) | (43,816 | ) | ||||
| 4.3 Net cash from / (used in) investing activities (item 2.6 above) | 32,342 | (30,418 | ) | |||||
| 4.4 Net cash from / (used in) financing activities (item 3.10 above) | (65 | ) | (492 | ) | ||||
| 4.5 Effect of movement in exchange rates on cash held | 2,549 | 5,387 | ||||||
| 4.6 Cash and cash equivalents at end of period | 92,451 | 92,451 |
| 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 | 22,141 | 19,206 | ||
| 5.2 Call deposits | 7,181 | 12,452 | ||
| 5.3 Bank overdrafts | ||||
| 5.4 Other (provide details if material) -Term deposit | 63,129 | 42,229 | ||
| 5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) | 92,451 | 73,887 |
| 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 | 363 | |||
| 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.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| 7. Financing facilities Note: the term facility includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. | Total facility amount at quarter end $A 000 | Amount drawn at quarter end $A 000 | ||
| 7.1 Loan facilities | ||||
| 7.2 Credit standby arrangements | ||||
| 7.3 Other (please specify) | ||||
| 7.4 Total financing facilities | ||||
| 7.5 Unused financing facilities available at quarter end | ||||
| 7.6 Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. | ||||
| N/A |
| 8. Estimated cash available for future operating activities | $A 000 | |||
| 8.1 Net cash from / (used in) operating activities (item 1.9) | (16,262 | ) | ||
| 8.2 Cash and cash equivalents at quarter end (item 4.6) | 92,451 | |||
| 8.3 Unused finance facilities available at quarter end (item 7.5) | ||||
| 8.4 Total available funding (item 8.2 + item 8.3) | 92,451 | |||
| 8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) | 5.69 | 1 | ||
| Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as N/A . Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. | ||||
| 8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions: | ||||
| 8.6.1 Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? | ||||
| Answer: |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| 8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? | ||
| Answer: | ||
| 8.6.3 Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? | ||
| Answer: | ||
| Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. |
Compliance statement
| Date: | 29 April 2025 | |
| Authorised by: | By the Board | |
| (Name of body or officer authorising release see note 4) |