Recent Updates
Recently added Catalysts
IMMP Positive Sentiment Score: 80/100

ASX/Media Release Immutep Quarterly Activities Report & Appendix 4C Q2 FY25 Marking Immutep s transition to a Phase III biotech, the Company s pivotal TACTI-004 trial in first-line non-small cell lung cancer (1L NSCLC) r

Key Takeaway: Immutep Limited has reported significant progress in its clinical developments, particularly announcing the initiation of the Phase III TACTI-004 trial for eftilagimod alfa in first-line non-small cell lung cancer (1L NSCLC). This transition marks a pivotal moment as the company moves forward with global regulatory approvals for the trial in over 25 countries. Additionally, encouraging results from the TACTI-003 Phase IIb trial highlight promising overall survival rates in patients with head and neck cancer. The company is well-funded, ensuring sustained research efforts into 2026.

Market Sentiment Analysis

POSITIVE FACTORS

  • Immutep has successfully initiated a Phase III trial for eftilagimod alfa in 1L NSCLC.
  • Positive results from TACTI-003 trial indicate high survival rates and favorable safety data.
  • Significant advancements in regulatory approvals for clinical trials across multiple countries.

Full Press Release Details

Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 31 January 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 December 2024 (Q2 FY25).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 Start of Phase III Trial in 1L NSCLC
In December 2024, Immutep initiated its pivotal TACTI-004 Phase III clinical trial of eftilagimod alfa
( efti ) for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The receipt of regulatory approval from the Australian Therapeutic Goods Administration means that Immutep
has transitioned into a Phase III company; a significant milestone for the Company.
Immutep has successfully completed regulatory submissions in the vast
majority of the more than 25 countries that will be part of the global TACTI-004 trial. Additional approvals from multiple countries are expected in the weeks and months ahead. The Company expects to enrol the
first patient in Q1 of CY2025.
TACTI-003 (KEYNOTE-C34) Phase
IIb Trial in 1L HNSCC
In December 2024, Immutep reported further positive results from Cohort B of the
TACTI-003 (KEYNOTE-C34) Phase IIb trial. Cohort B 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 patients (1L HNSCC) with PD-L1 negative tumours (CPS <1) who typically do not respond well to
anti-PD-1 therapy alone. The results were presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024.
Adding to the high response rates and favourable safety data previously reported in July 2024, the new data
showed that, encouragingly, median overall survival (OS) has not yet been reached and the 12-month OS rate is 67%. A promising progression-free survival (PFS) of 5.8 months, interim median duration of response
(DOR) of 9.3 months, 35.5% objective response rate (ORR) and 58.1% disease control rate (DCR) were also reported. The complete response rate increased to 12.9% and 16.1%, according to RECIST 1.1 and iRECIST, respectively. This data compares
favourably to historical results from anti-PD-1 therapy alone in 1L HNSCC patients with CPS <1. In addition, efti in combination with KEYTRUDA continues to be
well-tolerated with no new safety signals. Immutep will continue to follow the maturing data from TACTI-003 and engage with regulatory authorities regarding potential paths forward.
AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer
In October 2024, Immutep completed patient enrolment in the Phase II portion of the AIPAC-003 trial. The randomised
Phase II portion of the trial enrolled 65 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. 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. Data cleaning and analysis is ongoing.
Phase I Trial in Non-Squamous 1L NSCLC
In November 2024, first overall survival results were reported
from the investigator-initiated INSIGHT-003 trial evaluating efti in combination with KEYTRUDA (pembrolizumab) and doublet chemotherapy as first-line
treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
Mature data from patients with a minimum follow-up of 22 months (N=21) demonstrated results significantly exceeding
historical controls and expectations. Data included a median OS of 32.9 months, median PFS of 12.7 months, and a 24-month OS rate of 81.0%. Data from all evaluable patients to date (N=40) showed a marked
improvement in ORR compared to historical controls. Safety remains favourable with no new safety signals reported.
Subsequent to quarter end, patient
enrolment was completed for INSIGHT-003 in January 2025. The trial 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. Additional data updates are expected in 2025 and beyond.
Phase II Trial in Soft Tissue Sarcoma
Also in November, new data from the EFTISARC-NEO Phase II
investigator-initiated trial of efti in combination with radiotherapy plus KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (STS) were presented at the Connective Tissue
Oncology Society (CTOS) 2024 Annual Meeting.
Based on preliminary analysis, the triple combination therapy demonstrates significant efficacy in the
neoadjuvant setting for resectable STS. The combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median 50%) at the time of surgery as compared to a historical median of 15% from radiotherapy alone. In addition
to being the primary endpoint of the EFTISARC-NEO study, the tumour hyalinization/fibrosis rate has also been identified as a predictor of overall survival for STS patients in the neoadjuvant setting.
The EFTISARC-NEO trial, with a data cut-off of 20 October 2024, also
showed 71.4% of patients achieved a pathologic response defined as 35% of hyalinization/fibrosis and 9.5% of patients achieved a complete pathologic response. Additionally, the triple combination therapy is safe with no grade 3
toxicities related to efti and KEYTRUDA.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
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.
In December 2024, Immutep reported favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. There have been no treatment related adverse events in the first three of five single ascending dose cohorts in healthy
participants. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025.
Collaboration with Monash University
In December 2024, new findings that resolve how human lymphocyte activation gene 3 (LAG-3) binds to its main
ligand MHC Class II (MHC-II), also known as HLA Class II (HLA-II) in humans, were published in Science Immunology. The work by Monash University and
Immutep, is also the first to show the crystal structure of a human LAG-3/MHC-II complex and provides a better foundation for development of blocking LAG-3 therapeutics, including Immutep s anti-LAG-3 small molecule program.
INTELLECTUAL PROPERTY
During the quarter, Immutep was
granted three new patents for efti and IMP761 in various territories. In particular, Immutep was granted a new patent for efti in combination with a PD-1 pathway inhibitor for the treatment of infection from
the Brazilian Patent Office and a new patent for the same combination for the treatment of cancer or infection by the Japan Patent Office. In addition, a new patent was granted for IMP761 by the Malaysian Patent Office.
CORPORATE & FINANCIAL SUMMARY
Board & Senior Management Changes
Independent Non-Executive Director, Anne Anderson, tendered her resignation from the role, effective from 4 October 2024. The Board thanked her for her contribution to Immutep and wished her every success with her next
As Immutep s efti program has advanced into Phase III development, the Company has continued to grow and
evolve its team. As part of this, Christian Mueller, who has been with Immutep for over eight years, most recently as SVP Regulatory and Strategy has been promoted to Chief Development Officer. In addition, Dr Florian Vogl, Immutep s Chief
Medical Officer will depart the Company in April 2025. The Company s current Medical Affairs Advisor, who has been working in different roles closely with Immutep for over nine years, Dr Stephan Winckels, has been appointed acting CMO and taken
over all related responsibilities.
During the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash, cash
equivalent and term deposit balance as at 31 December 2024 of approximately A$159.26 million in total, which gives Immutep an expected cash reach to the end of CY2026. The A$159.26 million total balance consists of: 1) a cash and cash
equivalent balance of $73.89 million and 2) bank term deposits totalling A$85.37 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.
In Q2 FY25, cash receipts from customers were $8k. The net cash used in G&A activities in the quarter was $566k, compared to $961k in Q1 FY25. Payments to
Related Parties (detailed in item 6.1 of the Appendix 4C) comprises Non-Executive Directors fees and Executive Directors remuneration of $344k.
The net cash used in R&D activities during the quarter was $16.2 million, compared to $9.5 million to Q1 FY25. The increase is mainly due to the
increased level of clinical trial activities especially the commencement of the phase III TACTI-004 clinical trial. Payments for staff costs were $2.5 million in the quarter compared to $2.8 million
Total net cash outflows used in operating activities in the quarter were $19.0 million compared to $8.6 million in Q1 FY25.
Total cash flow used in investing activities for the quarter was $30.4 million, mainly due to the net increase of $30.0 million in 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 invested $35.3 million in short-term investments and transferred back
$5.3 million from short-term investments that had matured to cash at bank, resulting in a net increase in short-term investments of $30.0 million.
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 31 December 2024
Consolidated statement of cash flows Current quarter $A 000 Year to date (6 months) $A 000
1. Cash flows from operating activities
1.1 Receipts from customers 8 28
1.2 Payments for (16,222 ) (25,694 )
(a) research and development
(b) product manufacturing and operating costs
(c) advertising and marketing (32 ) (109 )
(d) leased assets
(e) staff costs (2,464 ) (5,239 )
(f) administration and corporate costs (566 ) (1,527 )
1.3 Dividends received (see note 3)
1.4 Interest received 799 2,001
1.5 Interest and other costs of finance paid (6 ) (17 )
1.6 Income taxes paid
1.7 Government grants and tax incentives 4,152
1.8 Other (provide details if material)-Intellectual property management (478 ) (1,149 )
1.9 Net cash from / (used in) operating activities (18,961 ) (27,554 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities
(b) businesses
(c) property, plant and equipment (10 ) (11 )
(d) investments (35,331 ) (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 (6 months) $A 000
(e) intellectual property (276 ) (276 )
(f) other non-current assets
2.2 Proceeds from disposal of:
(a) entities
(b) businesses
(c) property, plant and equipment
(d) investments 5,266 5,266
(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 (30,351 ) (62,760 )
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) (54 ) (173 )
3.10 Net cash from / (used in) financing activities (54 ) (427 )
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 120,343 161,790
4.2 Net cash from / (used in) operating activities (item 1.9 above) (18,961 ) (27,554 )

Frequently Asked Questions

What recent trial did Immutep start for NSCLC?

Immutep initiated the TACTI-004 Phase III trial for first-line metastatic NSCLC.

What are the results from TACTI-003 trial?

TACTI-003 data showed a 67% 12-month overall survival rate in patients with PD-L1 negative tumours.

What is the IMP761 program focused on?

IMP761 is designed to restore immune balance and address autoimmune diseases.

How much cash does Immutep have as of December 2024?

Immutep reported cash and equivalents totalling approximately A$159.26 million.

What progress has been made in patent approvals?

Immutep was granted three new patents for efti and IMP761 in various territories.

Last updated: Feb 3, 2025