Full Press Release Details
Half-Year Financial Report
For the Half-Year Ended
corresponding period: half-year ended 31 December 2023)
read in conjunction with the 30 June 2024 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 2024
Previous Reporting Period Half-year Ended 31 December 2023
| Revenues | to | |||||||||||||||
| Other Income | up | 77 | % | to | 7,276,004 | |||||||||||
| Total revenue and other income | up | 77 | % | to | 7,276,004 | |||||||||||
| Loss after tax attributable to members | up | 5 | % | to | (22,377,429 | ) | ||||||||||
| Net loss for the period attributable to members | up | 5 | % | to | (22,377,429 | ) |
The loss after tax for the half-year ended 31 December
2024 of A$22,377,429 was higher compared to A$21,228,191 for the half-year ended 31 December 2023. The increase in loss after tax for the period ended 31 December 2024 was mainly attributable to the following:
The above increases in total expenses were offset
partly by 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 2024 | 11.30 | |||
| As at 31 December 2023 | 8.99 |
| 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 | 27 | |||
| Independent Auditor s Review Report to the Members | 28 |
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 2024 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 2024.
The following persons were directors of Immutep during the whole of the half-year and up to the date of this report unless otherwise stated:
| 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) | |
| Ms Anne Anderson | (Non-Executive Director, resigned on 4 October 2024) |
PRINCIPAL ACTIVITIES
Immutep is a clinical stage biotechnology company developing novel Lymphocyte Activation Gene-3 (LAG3) 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 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 alpha (efti) through a Phase III clinical trial towards marketing approval in first
line non-small cell lung cancer (1L NSCLC). Also, the company has later stage clinical trials 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. The Company has other product candidates including IMP761 for which a Phase I study is in progress, for the treatment of autoimmune disease.
Good progress and encouraging clinical results have been reported by the Company throughout the half year. Immutep continues to develop multiple promising
assets and, with the commencement of TACTI-004, is now a Phase III stage biotech company.
Directors Report (Continued)
TACTI-004: Phase III trial in first line non-small cell lung cancer (1L
Phase IIb trial in first line head and neck squamous cell carcinoma (1L HNSCC)
| Immutep reported new clinical data from both Cohort A and B of the TACTI-003 trial during the half year. Cohort A Clinical data was reported from Cohort A of the TACTI-003 trial 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. The updated data from Cohort A showed that in patients with PD-L1 positive tumours (CPS 1), efti in combination with KEYTRUDA s outperformance was largest in CPS 20 with 31.0% objective response rate (ORR) (34.5% | TACTI-003 is Immutep s ongoing Phase IIb trial evaluating efti in combination with KEYTRUDA as a 1L therapy in approximately 154 patients with 1st line 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 pembrolizumab for this indication. The trial has two parts, patients in Cohort A have tumours that express PD-L1 (CPS >1) 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. | |
| ORR including a partial response recorded after data cut-off date) versus 18.5% ORR for KEYTRUDA monotherapy. Efti in combination with KEYTRUDA led to a high durability of response of 17.5 months in patients with CPS 1 and the combination continues to have favourable safety profile. Additionally, a statistically significant increase in absolute lymphocyte count, measured as an exploratory biomarker, was seen in the efti with KEYTRUDA arm indicating an effective efti-induced immune response in this randomised setting. |
Directors Report (Continued)
Updated clinical data from Cohort B was
presented at an ESMO Virtual Plenary session in early July 2024, with further data reported at the ESMO Immuno-Oncology (IO) Annual Congress 2024, in December. In patients with negative PD-L1 expression (CPS
<1) in Cohort B, efti in combination with KEYTRUDA achieved a 35.5% ORR. This is among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1.
The combination with efti also attained a high complete response rate of 9.7%, which compares favourably to a historical control of 0% from anti-PD-1 monotherapy in 1L
HNSCC patients with a CPS <1. Additionally, durability of responses was tracking well.
In December 2024, Immutep added to the high response rates and
favourable safety data reported in July 2024. The new data showed that positively, median overall survival (OS) had 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 continued to be well-tolerated with no new safety signals.
Immutep will continue to follow the maturing data from TACTI-003, with the most relevant endpoint of OS expected in 2025, and engage with regulatory authorities regarding potential paths forward, especially in the CPS<1 segment.
AIPAC-003: Integrated Phase II/III trial in Metastatic Breast Cancer
Directors Report (Continued)
Phase I and II Studies with Eftilagimod Alpha
TACTI-002: Phase II trial in NSCLC and HNSCC
EFTISARC-NEO: Phase II trial in Soft Tissue Sarcoma
Directors Report (Continued)
Institute of Clinical Cancer Research (IKF) INSIGHT Clinical Trial Platform
| INSIGHT-003 (Stratum C) - Phase I triple combination with standard-of-care anti-PD-1 therapy and chemotherapy INSIGHT-003 evaluates a triple combination therapy consisting of efti and an approved standard of care combination of chemotherapy (carboplatin and pemetrexed) and an anti-PD-1 therapy in approximately 50 patients with NSCLC adenocarcinomas. INSIGHT-003 continued to enroll patients throughout the half year, reaching its enrollment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF, following the period end in January 2025. | INSIGHT is an ongoing investigator-initiated Phase I clinical trial platform exploring efti in various combination treatments. It features five different arms, from strata A to E, with active arms detailed below. The trial is being conducted by the Institute of Clinical Cancer Research (IKF) at Northwest Hospital, Frankfurt, Germany. | |
| First overall survival results were reported from INSIGHT-003 in November 2024. 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 favorable with no new safety signals reported. Additional updates are expected in 2025 and beyond. |
INSIGHT-005 (Stratum E) - Phase I trial with Merck KGaA, Darmstadt, Germany, and
INSIGHT-005 is an open-label Phase I trial evaluating the safety and efficacy of efti in
combination with BAVENCIO (avelumab) in up to 30 patients with metastatic urothelial carcinoma. The study is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer,
the second collaboration agreement entered into by the three parties, with joint funding from Merck KGaA and Immutep. Patient recruitment continued throughout the half year.
Autoimmune Disease Clinical Development
IMP761 Phase I Trial
Directors Report (Continued)
IMP731 - LAG-3 depleting antibody
Out-Licensed Programs
EOC Pharma - Efti in China
While Immutep retains the
commercialisation rights to efti in all other territories, EOC Pharma is its exclusive development and commercialisation partner for efti (designated EOC202) in China, Hong Kong, Macau and Taiwan. Immutep is continuing to work with EOC Pharma to
support its plans to develop efti in China.
Novartis - Ieramilimab
Derived from Immutep s IMP701 antibody, Ieramilimab a humanised LAG-3 antagonist antibody which is under
development with Immutep s partner, Novartis. Novartis conducted clinical trials of ieramilimab (Novartis code: LAG525) in multiple cancer indications in combination with its PD-1 inhibitor,
Directors Report (Continued)
Laboratory Corporation of America Holdings, known
as LabCorp (NYSE: LH), is Immutep s collaboration partner for the development of LAG-3 products or services under a License and Collaboration Agreement.
During the half year, Immutep continued its support for the development of new products and services designed to meet growing demand in LAG-3. This included applying its in-depth LAG-3 expertise and knowledge to the work. Following the receipt of initial fees from
LabCorp in 2020, Immutep may be eligible to receive further revenues from commercial milestones as the collaboration progresses.
Intellectual Property Portfolio
Immutep was granted ten new patents for efti, IMP761 and LAG525 (ieramilimab) in various territories.
Two patents were granted for efti in combination
with a PD-1 pathway inhibitor in South Korea and Brazil. A patent was also granted in Mexico for a binding assay for determining MHC Class II binding activity. The assay is used in the characterisation of
efti in GMP-grade manufacturing.
New patents were also granted for efti in combination with a PD-1 pathway inhibitor for the treatment of infection from the Brazilian Patent Office and for the same combination for the treatment of cancer or infection by the Japan Patent Office.
Three new patents were granted for IMP761 in
India, Israel and Malaysia.
is exclusively licensed to Novartis by Immutep, two new patents were granted in Australia and Taiwan.
Corporate Summary & Financial
Independent Non-Executive Director, Anne Anderson, tendered her resignation from the role, effective from October 2024. The Board thanked her for her contribution to Immutep and wished her every success with her next
Immutep enters the ASX300
Immutep s considerable growth over the years as a listed company, the Company was added to the S&P/ASX 300 index following the September quarterly review of the S&P Dow Jones Indices. Joining the ASX300 enhances Immutep s market
visibility and supports investor confidence.
Financial Performance
During the current half-year reporting period, total revenue and other income increased from A$4.11 million to A$7.28 million. This was mainly as a
result of an increase of A$1.14 million in interest income and an increase in grant income by A$1.10 million.