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IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2023 (previous corresponding period: half-year ended 31 December 2022) To be read in conjunction with the 30 J

Key Takeaway: Immutep Limited reported its half-year financial results for the period ending December 31, 2023, showcasing a 59% increase in total revenue to A$4,110,397. However, the net loss attributable to members rose by 3%, reaching A$21,228,191 compared to A$20,623,250 for the same period last year. The company is advancing its lead immunotherapy candidate, efti, towards potential marketing approvals in various cancer indications, having received positive regulatory feedback in Europe and the USA. Immutep aims to commence a pivotal trial for efti in 2024, further bolstered by Fast Track designations from the FDA.

Market Sentiment Analysis

POSITIVE FACTORS

  • Total revenue and other income increased by 59% to A$4,110,397.
  • Obtained positive feedback from European regulatory authorities regarding efti.
  • Efti is progressing towards marketing approvals in multiple cancer indications.

CONCERNS & RISKS

  • Net loss for the period increased by 3% compared to the previous year.
  • Total expenses also rose, impacting financial performance.

Full Press Release Details

Half-Year Financial Report
(previous corresponding period: half-year ended 31 December 2022)
To be read in conjunction with the 30 June 2023 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 2023
Previous Reporting Period Half-year Ended 31 December 2022
Revenues to
Other Income up 59 % to 4,110,397
Total revenue and other income up 59 % to 4,110,397
Loss after tax attributable to members up 3 % to (21,228,191 )
Net loss for the period attributable to members up 3 % to (21,228,191 )
The loss after tax for the half-year ended 31 December 2023 of A$21,228,191 was higher compared to A$20,623,250 for the
half-year ended 31 December 2022. The increase in loss after tax for the period ended 31 December 2023 was mainly attributable to the following:
The above increases in total expenses were offset partly by
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 2023 8.99
As at 31 December 2022 7.58
Directors Report 3
Auditor s Independence Declaration 10
Half-Year Financial Report
Consolidated Statement of Comprehensive Income 11
Consolidated Balance Sheet 12
Consolidated Statement of Changes in Equity 13
Consolidated Statement of Cash Flows 14
Notes to the Consolidated Financial Statements 15
Directors Declaration 26
Independent Auditor s Review Report to the Members 27
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 2023 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 2023.
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, appointed on 14 February 2024)
PRINCIPAL ACTIVITIES
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related
immunotherapeutic products for cancer and autoimmune disease. It is dedicated to leveraging its technology and expertise to discover and develop novel immunotherapies, and to partner with leading organisations to bring innovative treatment options
to market for patients.
Its lead product candidate is eftilagimod alpha ( efti or IMP321 ), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism, which is in clinical development for the treatment of cancer. Immutep has two other clinical candidates,
IMP701 and IMP731. IMP701 is fully licensed to a major pharmaceutical partner. IMP731 has been licensed to a major pharmaceutical partner and is being transitioned back to the Company (for more details see page 7). The company has a fourth candidate
(IMP761) which is in pre-clinical development for autoimmune disease, as well as an early stage research project concerning a small molecule. Immutep is listed on the Australian Securities Exchange (IMM), and
on the NASDAQ (IMMP) in the United States.
Immutep is a late-stage biotechnology company developing novel LAG-3
related immunotherapies for cancer and autoimmune disease.
We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte
Activation Gene-3 (LAG-3). Our diversified product portfolio harnesses LAG-3 s unique ability to modulate the body s
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
Advancing Eftilagimod Alpha Through Late-Stage Development
Immutep is progressing efti through late-stage clinical trials towards potential marketing approvals in three cancer indications:
Directors Report (Continued)
During the half year, Immutep received positive scientific advice from the European Medicines Agency s
(EMA) Committee for Medicinal Products for Human Use (CHMP) advising that further toxicology studies are not needed for Immutep to submit a future Marketing Authorisation Application (MAA) for efti in Europe. Similar advice was previously received
from the US Food and Drug Administration (FDA) for a potential future Biologics License Application (BLA).
Additionally, the Company received
constructive feedback regarding its upcoming pivotal trial in 1st line NSCLC from the Paul-Ehrlich-Institut (PEI), a German regulatory authority and part of the Committee for Medicinal Products
for Human Use (CHMP), which is covered in more detail below.
Registrational trial in 1st line
TACTI-004 is Immutep s planned Phase III trial of efti in combination with an anti-PD-1 therapy in 1st line NSCLC patients. The FDA has granted Fast Track designation to efti for this indication in patients with a PD-L1 Tumor Proportion Score (TPS) of >1%, offering the potential for expedited development and review.
Immutep advanced the necessary preparations for the trial throughout the half year period, including regulatory interactions. In December 2023, Immutep
received constructive feedback from the Paul-Ehrlich-Institut (PEI), a German regulatory authority and part of the CHMP, regarding the planned trial. The PEI indicated its support for evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy and noted the good safety profile of efti in this combination.
Additional interactions with the FDA, other local European regulators, as well as with other stakeholders and potential partners are ongoing.
Immutep is uniquely positioned to address multiple patient populations within non-small cell lung cancer as defined by
their level of PD-L1 expression, including high (TPS >50%), low (TPS 1-49%), and negative (TPS <1%) expressors, with either efti combined with anti-PD-1 therapy or a triple combination approach including chemotherapy. Immutep expects to commence the trial in CY2024.
Late-stage trial with Fast Track designation in 1st line HNSCC
TACTI-003 - Phase IIb
TACTI-003 is Immutep s ongoing Phase IIb trial evaluating efti in combination with KEYTRUDA (pembrolizumab) as a first line treatment in patients with HNSCC. It is a randomised, multicenter clinical trial conducted under a Clinical Trial Collaboration and Supply Agreement between
Immutep and Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada). Immutep has FDA Fast Track designation for this indication with the potential for expedited development and review.
Immutep completed patient enrolment for TACTI-003 in November 2023. Of the 171 patients participating, 138 patients
have PD-L1 positive (Combined Positive Score [CPS] 1) tumours (Cohort A) and 33 patients have PD-L1 negative tumours (Cohort B). Patients in Cohort A whose tumors
express PD-L1 (CPS >1) are stratified by CPS 1-19 and CPS >20, and the clinical results for these three CPS groups will be evaluated.
The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival,
Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. The primary analysis according to the trial protocol will be performed after all subjects have completed at least three cycles of treatment (18 weeks in
total) or discontinued the trial, and all relevant data for the primary endpoint has been collected, cleaned, and analysed.
Immutep expects to report
first data from TACTI-003 in H1 CY2024.
Directors Report (Continued)
Late-stage integrated trial in Metastatic Breast Cancer
AIPAC-003 Phase II/III
AIPAC-003 is an integrated
Phase II/III trial evaluating efti in combination with standard-of-care paclitaxel (a chemotherapy) for the treatment of metastatic
HER2-neg/low breast cancer and triple-negative breast cancer, which together account for ~78% of breast cancer cases. The study is taking place at different clinical sites across Europe and the US.
During the first half, Immutep completed the safety lead-in portion of the
AIPAC-003 trial evaluating for the first time 90mg of efti in combination with paclitaxel in 6 patients during the quarter. The treatment was well tolerated with no dose limiting toxicities. Following the
recommendation of the independent Data Monitoring Committee (IDMC), the Company proceeded into the randomised (1:1) portion of the Phase II study consisting of up to 58 evaluable patients who will receive 30mg efti or 90mg efti to determine the
optimal biological dose in combination with paclitaxel. Currently 21 patients have been dosed in the randomized part.
Depending on the Phase II results,
potential regulatory actions and resources, the Phase III portion of the trial will potentially follow, providing a risk-balanced approach for Immutep. If it proceeds, the Phase III study will be a randomised, double-blinded, placebo-controlled
trial evaluating Overall Survival of patients as its primary objective and may include a specific patient population.
Phase I and II Studies with
TACTI-002 (also designated KEYNOTE-798)
Phase II Trial in 1st line NSCLC (Part A)
Immutep s ongoing Phase II trial being
conducted in collaboration with MSD and evaluating efti in combination with MSD s anti-PD-1 therapy
KEYTRUDA (pembrolizumab) in patients with 1st line NSCLC (Part A). The trial is an all-comer study
meaning patients can participate regardless of their PD-L1 biomarker status. It is a non-comparative, open-label, single-arm,
multicentre clinical study at 18 centres across Australia, Europe and the US, which completed patient recruitment in late 2021.
continuing to follow patients from Part A of TACTI-002, reporting excellent Overall Survival results in patients with metastatic NSCLC at the ESMO Congress 2023 in Spain during the half year. Exceeding our
expectations, median Overall Survival has reached 35.5 months in NSCLC patients expressing PD-L1 (patients with a TPS of >1%), 23.4 months in patients with low
PD-L1 expression (TPS 1-49%), and encouragingly has not yet been reached in patients with high PD-L1 expression (TPS
>50%). Efti in combination with pembrolizumab is enabling deep, durable responses for patients regardless of PD-L1 expression with a favourable safety profile that is in line with anti-PD-1 monotherapy.
survival benefit seen in patients with a TPS of >1% gives these patients 12 to 18 months of additional survival compared to historical data from current
standard-of-care immuno-oncology (IO) monotherapy and IO-IO or IO-chemotherapy options,
including pembrolizumab in combination with doublet chemotherapy. In addition to the substantial survival benefit, the combination of efti and pembrolizumab is chemotherapy-free, avoiding the toxic side effects seen in chemotherapy options.
Following the efficacy results, new biomarker data from the trial was presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November
2023. The data demonstrated an early increase in immune cells (absolute lymphocyte count) was linked to improved clinical outcomes including the OS as detailed above.
EFTISARC-NEO Phase II Trial in Soft Tissue Sarcoma

Frequently Asked Questions

What was Immutep's revenue for the half-year ended December 2023?

Immutep's revenue and other income for the half-year ended December 2023 reached A$4,110,397.

How much was the net loss for Immutep in December 2023?

The net loss for Immutep in December 2023 was A$21,228,191, a 3% increase from 2022.

What is Immutep’s lead product candidate?

Immutep's lead product candidate is eftilagimod alpha (efti or IMP321) for cancer treatment.

What significant designation did efti receive from the FDA?

Efti received Fast Track designation from the FDA for non-small cell lung cancer indications.

When is Immutep expected to report data from TACTI-003?

Immutep expects to report results from the TACTI-003 trial in the first half of CY2024.

Last updated: Feb 29, 2024