Full Press Release Details
Half-Year Financial Report
(previous corresponding period: half-year ended 31 December 2024)
To be read in conjunction with the 30 June 2025 Annual Report.
In compliance with Listing Rule 4.2A.
ASX/Media Release (ASX:
Appendix 4D Half-Year Financial Report
Results for Announcement to the Market
Current Reporting Period - Half-year Ended 31 December 2025
Previous Reporting Period - Half-year Ended 31 December 2024
| Revenues | up | n/a | to | 4,080,294 | ||||||
| Other Income | down | 50% | to | 3,655,205 | ||||||
| Total revenue and other income | up | 6% | to | 7,735,499 | ||||||
| Loss after tax attributable to members | up | 100% | to | (44,859,721 | ) | |||||
| Net loss for the period attributable to members | up | 100% | to | (44,859,721 | ) |
The loss after tax for the half-year ended 31 December 2025 of A$44,859,721 was higher compared to A$22,377,429 for the
half-year ended 31 December 2024. The increase in loss after tax for the period ended 31 December 2025 was mainly attributable to the following:
| Dividends (Distribution) | Amount per Security | Franked Amount per Security | ||||||
| Final dividend | n/a | n/a | ||||||
| Previous corresponding period | n/a | n/a | ||||||
| Record date for determining entitlements to the dividend (in the case of a trust, distribution) | n/a |
Net Tangible Assets per Share (cents)*
| As at 31 December 2025 | 6.31 | |||
| As at 31 December 2024 | 11.30 |
| Directors' Report | 3 | |||
| Auditor's Independence Declaration | 11 | |||
| Half-Year Financial Report | ||||
| Consolidated Statement of Comprehensive Income | 12 | |||
| Consolidated Balance Sheet | 13 | |||
| Consolidated Statement of Changes in Equity | 14 | |||
| Consolidated Statement of Cash Flows | 15 | |||
| Notes to the Consolidated Financial Statements | 16 | |||
| Directors' Declaration | 29 | |||
| Independent Auditor's Review Report to the Members | 30 |
This half-year financial report does not include all the notes of the type normally included in an annual financial report.
Accordingly, this report should be read in conjunction with the annual report for the year ended 30 June 2025 and any public announcements made by Immutep Limited during the half-year reporting period in accordance with the continuous
disclosure requirements of the Corporations Act 2001.
Immutep Limited is a company limited by shares, incorporated and domiciled in Australia. Its
registered office and principal place of business is at Level 32, 264 George Street, Australia Square, SYDNEY, NSW 2000. Its shares are listed on the Australian Securities Exchange (ASX) and NASDAQ Global Market (NASDAQ).
Your directors present their report on
the group consisting of Immutep Limited and the entities it controlled at the end of, or during (referred to hereafter as the "Group" or "Immutep" and or the "Company") the half-year ended 31 December 2025.
The following persons were directors of
Immutep during the whole of the half-year and up to the date of this report:
| Dr Russell Howard | (Non-Executive Chairman) | |
| Mr Pete Meyers | (Non-Executive Director & Deputy Chairman) | |
| Mr Marc Voigt | (Executive Director & Chief Executive Officer) | |
| Dr Fr d ric Triebel | (Executive Director & Chief Scientific Officer) | |
| Ms Lis Boyce | (Non-Executive Director) |
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 it to address autoimmune diseases.
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 (TACTI-004 / KEYNOTE-F91) towards marketing approval in first line advanced or metastatic non-small cell lung cancer (1L NSCLC). Efti
is a first-in-class novel immunotherapy that directly activates the immune system to fight cancer. The Company has multiple trials evaluating efti in other oncology
indications including head and neck cancer, breast cancer, and soft tissue sarcoma. In autoimmune diseases, a Phase I study is in progress for another product candidate called IMP761, a
first-in-class LAG-3 agonist antibody.
Strong progress and encouraging clinical results have been reported throughout the half-year for both efti and IMP761.
IMMUTEP AND DR. REDDY'S STRATEGIC COLLABORATION
the half-year, Immutep and Dr. Reddy's announced that their respective wholly-owned subsidiaries, Immutep SAS and Dr. Reddy's Laboratories SA, had entered into a strategic collaboration and licensing agreement for the
development and commercialisation of efti in all countries outside North America, Europe, Japan, and Greater China.
As per the agreement, Immutep has
received from Dr. Reddy's an upfront payment of USD 20 million (AUD 29.9 million) subsequent to the half-year reporting period. It is also eligible to receive potential regulatory, development and commercial milestone payments of up
to USD 349.5 million (approximately AUD 528.4 million), plus royalties on commercial sales of efti in these markets.
Immutep retains the global
manufacturing rights (except Greater China*) to efti across all markets and will supply the product to Dr. Reddy's in the licensed markets. Additionally, Immutep retains all commercial rights to efti in key pharmaceutical markets,
including North America, Europe, and Japan.
Director's Report (Continued)
TACTI-004: Phase III trial in first line non-small cell lung cancer (1L NSCLC)
1L NSCLC is one of the most significant cancer indications with a high unmet medical need. The TACTI-004 trial is designed to set a new standard of care in 1L NSCLC and is a key value driver for Immutep.
half-year, Immutep presented Trial in Progress posters for TACTI-004 at the IASLC World Conference on Lung Cancer (WCLC) in Barcelona, Spain and at the European Society for Medical Oncology (ESMO) Congress
2025 in Berlin, Germany. These presentations included an overview of the trial and its study design, with encouraging physician feedback received on both fronts.
In October, Immutep reported that TACTI-004 had enrolled the required number of patients to conduct the futility
analysis, which remains on track for the first quarter of CY2026, with full patient enrolment expected in the third quarter of CY2026.
In mid-December, Immutep reported strong operational progress for TACTI-004. The trial had enrolled 289 patients with enrolment continuing at a robust pace. Additionally,
subsequent to the half-year period, 140 clinical sites had been activated and full regulatory approvals had been received in 27 countries and 50% of the targeted patient population has been recruited by early February 2026. TACTI-004 has started to open sites in the United States following completion of the FDA's Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals.
(KEYNOTE-F91) is Immutep's registrational Phase III trial in advanced or metastatic 1L NSCLC 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 at no charge.
TACTI-004 is a 1:1 randomised, double-blind, multinational, controlled study, with dual primary
endpoints of progression-free survival and overall survival. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo
The pivotal trial will take place in over 150 clinical sites in over 25 countries across the
globe. It will enrol approximately 756 patients regardless of PD-L1 expression (TPS 0-100%) and include both squamous and
non-squamous subtypes to address almost the entire 1L NSCLC market eligible for anti-PD-1 therapy.
TACTI-003: Phase IIb trial in first line head and neck squamous cell carcinoma (1L HNSCC)
During the reporting period Immutep received positive and constructive feedback from the US Food and Drug
Administration (FDA), regarding the future late-stage clinical development of efti in first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1
expression below 1 (Combined Positive Score [CPS]<1).
TACTI-003 is Immutep's ongoing Phase IIb trial
evaluating efti in combination with KEYTRUDA as first line therapy in patients with HNSCC, taking place across Australia, Europe and the US at over 30 clinical sites. It is being conducted in collaboration with MSD. Enrolment into the trial was
completed in November 2023. Immutep has FDA Fast Track designation with the potential for expedited development and review for the combination of efti with pembrolizumab for this indication.
Based on its review of the encouraging data
in 1L HNSCC with CPS <1 from TACTI-003 (KEYNOTE-C34), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination's further development. Paths for future clinical development and potential accelerated
approval in light of the FDA's Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care
therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, that would build on the existing data and would be
followed by a confirmatory randomised study.
Director's Report (Continued)
AIPAC-003: Integrated Phase II/III trial in Metastatic Breast
Immutep completed patient enrolment in the randomised Phase II portion of the
AIPAC-003 trial in late 2024. The Phase II study randomised participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to
endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based
therapy. Patients across 22 clinical sites in Europe and the United States were randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA's
Project Optimus initiative.
AIPAC-003 is an integrated Phase II/III trial evaluating
efti in combination with chemotherapy (paclitaxel) for the treatment of metastatic HER2-neg/low breast cancer and triple-negative breast cancer. The Phase II study was randomised 1:1 for patients to receive
either 30 mg efti or 90 mg efti to determine the optimal biological dose, consistent with the FDA's Project Optimus initiative.
In October, Immutep announced that
positive feedback had been received from the US Food and Drug Administration (FDA) regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for efti. The agreement with the FDA on
efti's optimal biological dosing carries strategic importance in the ongoing and future clinical development of efti, including the global TACTI-004 (KEYNOTE-F91)
In December, Immutep announced new data from AIPAC-003 was presented by Dr. Nuhad Ibrahim,
Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center at the 2025 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The data presented shows that both efti
dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9%
and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64).
New Investigator-Initiated Phase II
trial for Neoadjuvant Efti in Early-Stage Breast Cancer
In September, Immutep announced the launch of an investigator-initiated Phase II trial
evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients. The trial, led by Dr. Pavani Chalasani, MD, MPH, Division Director of Hematology and
Medical Oncology at The George Washington (GW) University Cancer Center, aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC).The study will recruit up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget.
Director's Report (Continued)
EFTISARC-NEO: Phase II trial in Soft Tissue Sarcoma
In October, Immutep announced that positive data from the EFTISARC-NEO
Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) was shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria