Full Press Release Details
Preliminary final report
PRELIMINARY FINAL REPORT
| Name of entity: | Immutep Limited | |
| ABN: | 90 009 237 889 | |
| Reporting period: | Year ended 30 June 2025 | |
| Previous corresponding period: | Year ended 30 June 2024 |
| FY2024 | FY2025 | |||||||
| Revenue from ordinary activities | No change | - | to | - | ||||
| Other income | Up | 7,838,625 | to | 10,331,373 | ||||
| Loss from ordinary activities after tax attributable to the owners of Immutep Limited | Up | (42,716,625) | to | (61,434,165) | ||||
| Loss for the period attributable to the owners of Immutep Limited | Up | (42,716,625) | to | (61,434,165) | ||||
| Dividends There were no dividends paid or declared during the current financial period. |
Explanation of the above information:
The increase in loss after tax for the financial year ended 30 June 2025 was mainly attributable to the following:
For other details of the current year results, refer to the Review of Operations and Activities.
| Net tangible asset backing per ordinary security | Reporting period | Previous corresponding period | ||
| 9.3 cents | 12.5 cents |
no dividends paid or declared during the current financial period.
Previous corresponding period
There were no dividends paid or declared during the previous financial period.
Details of attachments (if any):
The annual report for the year ended 30 June 2025 is attached.
| Date: Friday, 29 August 2025 | ||
| Company Secretary |
This report is based on financial statements which have been audited.
| CORPORATE DIRECTORY | 1 | |||
| CHAIRMAN'S LETTER | 2 | |||
| REVIEW OF OPERATIONS AND ACTIVITIES | 4 | |||
| DIRECTORS' REPORT | 12 | |||
| AUDITOR'S INDEPENDENCE DECLARATION | 34 | |||
| CORPORATE GOVERNANCE STATEMENT | 35 | |||
| ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORT | 35 | |||
| FINANCIAL STATEMENTS | 36 | |||
| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME | 37 | |||
| CONSOLIDATED BALANCE SHEET | 38 | |||
| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | 39 | |||
| CONSOLIDATED STATEMENT OF CASH FLOWS | 40 | |||
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS | 41 | |||
| CONSOLIDATED ENTITY DISCLOSURE STATEMENT (CEDS) | 81 | |||
| DIRECTORS' DECLARATION | 82 | |||
| INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF IMMUTEP LIMITED | 83 | |||
| SHAREHOLDER INFORMATION | 88 |
| Directors | ||||
| Dr Russell Howard | (Non-Executive Chairman) | |||
| Mr Pete Meyers | (Non-Executive Director & Deputy Chairman) | |||
| Mr Marc Voigt | (Executive Director & Chief Executive Officer) | |||
| Prof. Fr d ric Triebel | (Executive Director & Chief Scientific Officer) | |||
| Ms Lis Boyce | (Non-Executive Director) | |||
| Ms Anne Anderson | (Non-Executive Director; resigned on 4 October 2024) | |||
| Company Secretaries | Ms Deanne Miller | |||
| Ms Indira Naidu | ||||
| Registered office & | Level 32 | |||
| principal place of business | 264 George Street | |||
| Australia Square | ||||
| Sydney, NSW 2000 | ||||
| +61 2 8315 7003 | ||||
| Share Registry | Boardroom Pty Ltd | |||
| Level 8, 210 George Street | ||||
| Sydney, NSW 2000 | ||||
| +61 2 9290 9600 | ||||
| Auditor | PricewaterhouseCoopers | |||
| One International Towers Sydney, Watermans Quay | ||||
| Barangaroo, NSW 2000 | ||||
| Banker | National Australia Bank Ltd | |||
| Kew Branch | ||||
| Melbourne, Victoria 3000 | ||||
| Stock exchange listings | Immutep Limited shares are listed on the: | |||
| Australian Securities Exchange (ASX code: IMM), and | ||||
| NASDAQ Global Market (NASDAQ code: IMMP) | ||||
| Website address | www.immutep.com |
Dear Fellow Shareholders,
On behalf of the Board, I'm
pleased to present Immutep Limited's ( IMM') Annual Report for the 2025 Financial Year ( FY25').
FY25 has been a pivotal
year for Immutep, marked by our successful transition into a Phase III biotechnology company and strong execution across our clinical programs. We continued to build on our leadership in Lymphocyte Activation
Gene-3 (LAG-3) immunotherapy, delivering on key milestones and generating compelling clinical data across both oncology and autoimmune disease pipelines.
Our lead immuno-oncology candidate, eftilagimod alfa (efti), advanced into a global registrational Phase III trial in
non-small cell lung cancer (TACTI-004/KEYNOTE-F91), with the first patient dosed in March 2025. This trial is being conducted in
collaboration with MSD, who is supplying KEYTRUDA (pembrolizumab) for the study. TACTI-004 is among a select few global Phase III studies evaluating
combination therapies with KEYTRUDA that target a broad 1L NSCLC patient population, and represents our most significant program to date. We are encouraged by the momentum of this registrational trial.
We also reported maturing data from TACTI-003, our Phase IIb trial in head and neck squamous cell carcinoma (HNSCC).
In May 2025, we announced a median overall survival (OS) of 17.6 months in patients with PD-L1 expression below 1 (CPS <1) from the chemotherapy-free combination of efti with KEYTRUDA. This median OS is
substantially higher than the current standards of care, reinforcing the value of efti's unique mechanism of action and excellent safety profile when used in combination with
anti-PD-1 therapies. Immutep has Fast Track designation from the FDA for efti in this indication.
In metastatic breast cancer, we completed enrolment in the Phase II portion of our AIPAC-003 trial that is evaluating
efti in combination with chemotherapy and continued patient follow-up throughout the year. This study helped determine the optimal biological dose of 30mg for efti while addressing an underserved patient
population that has exhausted endocrine therapy options. We look forward to sharing further data by the end of CY2025.
INSIGHT-003 investigator-initiated trial, which is evaluating efti in combination with KEYTRUDA and chemotherapy in 1L non-squamous NSCLC, continued to deliver pleasing
results. A high 60.8% objective response rate and 90.2% disease control rate were observed across all PD-L1 expression levels. The results were most impressive in patients of high unmet need with PD-L1 expression below 50%. Importantly, these results provide strong validation for the rationale underpinning our Phase III TACTI-004 trial design using the same combination
therapy. Data from INSIGHT-003 has been accepted for a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in October.
We also reached a significant milestone in soft tissue sarcoma with the completion of patient enrolment and the announcement that the investigator-initiated EFTISARC-NEO trial had met its primary endpoint. This Phase II trial demonstrated a marked increase in tumour hyalinization, a surrogate marker of long-term survival, when efti was added to radiotherapy and anti-PD-1 treatment. Data from this trial has been accepted for a Proffered Paper oral presentation at the ESMO Congress 2025.
In the autoimmune space, our first-in-human Phase I trial of IMP761, a first-in-class LAG-3 agonist antibody, progressed through multiple dose cohorts. Encouragingly, at the highest dose tested to date (0.9
mg/kg), IMP761 showed a favourable safety profile and a promising 80% reduction in T cell activity in skin tissue. These early results support IMP761's potential to selectively silence overactive memory T cells and restore immune balance
without broadly and unnecessarily suppressing the immune system.
Immutep's leadership in LAG-3
immunotherapy continues to be recognised through its continuing partnerships and growth of our intellectual property estate. In FY25, we were granted 17 new patents across key territories for both efti and IMP761, and landmark research from our
collaboration with Monash University was published in Science Immunology, detailing the first-ever crystal structure of the human LAG-3/MHC-II complex providing a
better foundation for the development of other LAG-3 therapies, such as Immutep's anti-LAG-3 small molecule program.
Immutep was added to the S&P/ASX 300 Index in the September 2024 review, demonstrating investor confidence in our trajectory and growth.
Financially, we maintained a strong balance sheet throughout the year. We ended FY25 with a cash and term
deposit balance of A$129.7 million, providing a cash runway through to the end of CY2026. This prudent financial management enables us to progress our clinical trials on schedule.
I am particularly proud of our team's progress throughout FY25 considering the complex challenges currently impacting the biotechnology sector.
Regulatory uncertainty remains a significant concern, particularly as agencies such as the FDA continue to refine their requirements and change their guidelines related to diversity in clinical trial recruitment. These evolving standards can impact
approval timelines and the strategic direction of companies investing in clinical trials.
Supply chain disruptions present additional hurdles, affecting
everything from access to critical raw materials to the overall cost structure, including heightened tax implications due to shifting international regulations. Geopolitical instability further compounds these issues, influencing market access,
investment flows, and collaboration opportunities globally.
As we navigate changing conditions, our focus remains on execution and completion of our
clinical trials with a priority on our global registrational Phase III trial in non-small cell lung cancer
(TACTI-004/KEYNOTE-F91) where we are eager to see efti validated clinically, and with success, provide a meaningful benefit to cancer patients. On behalf of the Board, I
would like to acknowledge key leadership changes during the year. Independent Non-Executive Director Anne Anderson tendered her resignation effective 4 October 2024, and the Board thanks her for her
contribution to Immutep and wishes her well. I would also like to thank Dr Stephan Winckels for accepting the role of Chief Medical Officer following the departure of Dr Florian Vogl and congratulate Christian Mueller on his promotion to Chief
Development Officer. Dr Winckels' and Mr Mueller's deep knowledge of our clinical programs and longstanding involvement with efti will be invaluable as we navigate the next stages of development.
As we look ahead, FY26 promises to be another year of meaningful progress. You can expect continued momentum for
TACTI-004, data updates from AIPAC-003, INSIGHT-003, and EFTISARC-NEO, and further
advancement in our autoimmune portfolio with IMP761.
Our team remains focused on our mission to develop innovative immunotherapies that offer new hope to
patients with cancer and autoimmune diseases. We are grateful for the continued support of our shareholders as we work to deliver long-term value and transformative outcomes.
REVIEW OF OPERATIONS AND ACTIVITIES
PRINCIPAL ACTIVITIES
Immutep is a Phase III, clinical
biotechnology company developing novel Lymphocyte Activation Gene-3 (LAG-3) related immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the
understanding and advancement of therapeutics related to LAG-3. It has a diversified product portfolio that harnesses LAG-3's unique ability to stimulate the
body's immune response to fight cancer or suppress the immune system to treat autoimmune disease.
Immutep is dedicated to leveraging its expertise
to bring innovative treatment options to patients in need and to maximise value for shareholders. The Company is listed on the Australian Securities Exchange (IMM) and on the NASDAQ (IMMP) in the United States.
REVIEW OF OPERATIONS
Immutep is focused on advancing its
lead product candidate, eftilagimod alfa (efti) through its registrational Phase III clinical trial towards marketing approval in first line non-small cell lung cancer (1L NSCLC). Later stage clinical studies
are also being performed in first line head and neck squamous cell carcinoma (1L HNSCC) and metastatic breast cancer. The Company has multiple active trials evaluating efti across these indications and others, and has begun clinical trials of IMP761
for the treatment of autoimmune disease. Strong progress and encouraging clinical results have been reported throughout the year.
TACTI-004: Phase III trial in first line non-small cell lung cancer (1L NSCLC)
| 1L NSCLC is one of the most prevalent cancer indications and has a high unmet medical need. The TACTI-004 Phase III trial is designed to set a new standard of care and is a key value driver for Immutep. | TACTI-004 is Immutep's registrational Phase III trial of efti in combination with an anti-PD-1 therapy in 1L NSCLC patients. This pivotal trial is evaluating efti in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) and chemotherapy. The study is taking place under Immutep's third collaboration with MSD, with Immutep conducting the trial and retaining the commercial rights to efti, while MSD is supplying KEYTRUDA. TACTI-004 will enrol approximately 750 patients regardless of PD-L1 expression and include both squamous and non-squamous subtypes to address almost the entire 1L NSCLC market eligible for anti-PD-1 therapy. It is a 1:1 randomised, double-blind, multinational, controlled study, with dual primary endpoints of progression-free survival and overall survival and will include over 150 clinical sites in over 25 countries across the globe. | |
| In July 2024, Immutep received positive feedback from the US Food and Drug Administration (FDA) on the design of TACTI-004, building on previously received guidance from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products. | ||
| In December 2024, the first regulatory approval for TACTI-004 in any region was received by Immutep from the Australian Therapeutic Goods Administration. | ||
| In March 2025, Immutep announced the first patient in TACTI-004 was successfully dosed at Calvary Mater Newcastle Hospital in Australia. Since then, the trial is on track and continues to build momentum by recruiting patients at a growing number of activated clinical sites and countries, with 23 countries having received regulatory approval and 88 clinical sites ready to enroll patients as of the middle of August 2025. |
In late March 2025, Immutep presented the TACTI-004 trial design as a Trial-in-Progress poster at the European Lung Cancer Congress (ELCC) 2025 in Paris, France. Immutep also presented a Trial-in-Progress poster for TACTI-004 at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in the United States in late May.
TACTI-004 is on track with guidance to end of CY2025/Q1 CY2026 for futility analysis readout.
REVIEW OF OPERATIONS AND ACTIVITIES (CONTINUED)
Immutep has seen encouraging support from the investigators participating in the study and in the meetings to
date including those held at ELCC 2025, ASCO 2025, and an international investigator meeting in Budapest, Hungary.
TACTI-003: Phase IIb trial in first line head and neck squamous cell carcinoma (1L HNSCC)
| Immutep reported new clinical data from the TACTI-003 (KEYNOTE-C34) Phase IIb trial during the year. | TACTI-003 is Immutep's ongoing Phase IIb trial evaluating efti in combination with KEYTRUDA as a 1L therapy in approximately 154 patients with HNSCC. It is a randomised, controlled clinical study taking place across Australia, Europe and the US in up to 35 clinical sites and is being conducted in collaboration with MSD. Immutep has FDA Fast Track designation with the potential for expedited development and review for the combination of efti with KEYTRUDA for this indication. The trial has two parts, patients in Cohort A have tumours that express PD-L1 (CPS 1) and are stratified by CPS 1-19 and CPS 20, and patients in Cohort B have PD-L1 negative tumours (CPS <1). Enrolment into the trial was completed in November 2023. | |
| Cohort A | ||
| Clinical data from Cohort A of TACTI-003 was reported in a late-breaking abstract and prestigious Proffered Paper oral presentation at ESMO Congress 2024 in September. Late-breaking abstracts are reserved for high-quality, new research findings from randomised phase II or phase III trials with implications for clinical practice or understanding of disease processes. Proffered Papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives. | ||
| Although the updated data from Cohort A showed that patients with PD-L1 positive tumours (CPS 1), who received efti in combination with KEYTRUDA outperformed the KEYTRUDA monotherapy arm, it is difficult to draw conclusions from the data in this cohort due to a number of imbalances of prognostic markers in favour of the KEYTRUDA monotherapy arm, including HPV status, smoking status, and primary tumour location. Additionally, in the KEYTRUDA monotherapy arm, patients with a CPS of 1-19 demonstrated higher objective response rates than those with CPS 20. This finding is atypical for KEYTRUDA therapy, as higher CPS levels are generally associated with improved outcomes compared to lower CPS levels. |
from Cohort B of TACTI-003 was presented at an ESMO Virtual Plenary session in early July 2024. In patients with negative PD-L1 expression (CPS <1) in Cohort B, efti
in combination with KEYTRUDA achieved a 35.5% objective response rate (ORR). This is among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1.
In December 2024, Immutep released new data at the ESMO Immuno-Oncology (IO) Annual Congress 2024 which showed that median overall survival (OS) had not yet
been reached and a 12-month OS rate of 67%. A promising progression-free survival (PFS) of 5.8 months, interim median duration of response (DOR) of 9.3 months, and complete response rate of 12.9% and 16.1%,
according to RECIST 1.1 and iRECIST respectively, were reported. A 35.5% ORR and 58.1% disease control rate (DCR) were also reported. 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 continued to be well-tolerated with no new safety signals.
In May 2025, Immutep announced that an excellent median OS of 17.6 months had been achieved in Cohort B in 1L HNSCC with CPS <1 in evaluable patients
(N=31) with a data cut-off of 31 March 2025.
This mature OS data 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
REVIEW OF OPERATIONS AND ACTIVITIES (CONTINUED)
Given the harder to interpret Cohort A data, the imbalance of the control arm, and the competitive situation