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IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2021 (previous corresponding period: half-year ended 31 December 2020) To be read in conjunction with the 30 J

Key Takeaway: Half-Year Financial Report (previous corresponding period: half-year ended 31 December 2020) To be read in conjunction with the 30 June 2021 Annual Report. In compliance with Listing Rule 4.2A. ASX/Media Release (ASX: IMM) Appendix 4D Half-Year Financial Report Results for

Full Press Release Details

Half-Year Financial Report
(previous corresponding period: half-year ended 31 December 2020)
To be read in conjunction with the 30 June 2021 Annual Report.
In compliance with Listing Rule 4.2A.
ASX/Media Release (ASX: IMM)
Appendix 4D Half-Year Financial Report
Results for Announcement to the Market
Current Reporting Period Half-year Ended 31 December 2021
Previous Reporting Period Half-year Ended 31 December 2020
Revenues to
Other Income Up 26.2 % to 2,851,745
Total revenue and other income Up 26.2 % to 2,851,745
Loss after tax attributable to members Down 18.0 % to (16,270,213 )
Net loss for the period attributable to members Down 18.0 % to (16,270,213 )
The loss after tax for the half-year ended 31 December 2021 of A$16,270,213 was significantly lower compared to
A$19,844,146 for the half-year ended 31 December 2020. There was a significant loss of A$8,057,161 from the net change in fair value of warrants for the half-year ended 31 December 2020, in comparison to the half-year ended
31 December 2021, which was a gain of A$184,528.
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 2021 11.37
As at 31 December 2020 7.22
Directors Report 3
Auditor s Independence Declaration 9
Half-Year Financial Report
Consolidated Statement of Comprehensive Income 10
Consolidated Balance Sheet 11
Consolidated Statement of Changes in Equity 12
Consolidated Statement of Cash Flows 13
Notes to the Consolidated Financial Statements 14
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 2021 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 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 2021.
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)
Mr Grant Chamberlain (Non-Executive Director deceased on 28 January 2022)
The directors of Immutep are currently working on a process to appoint a new Australian resident director and will
announce the new appointment as soon as practicable.
Principal Activities
Immutep is a globally active biotechnology company and is a leader in the development of LAG-3 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
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) that are worldwide, exclusively licensed to major pharmaceutical partners, and a fourth candidate (IMP761) which is in pre-clinical development for autoimmune disease.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
REVIEW OF OPERATIONS AND ACTIVITIES
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3
immunotherapeutic products for cancer and autoimmune disease, with currently more product candidates and programs focused on LAG-3 than any other drug development company. 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.
Immutep has four product candidates based on the LAG-3 immune control mechanism in development, all with different
mechanisms of action. Its lead in-house product candidate is eftilagimod alpha ( efti or IMP321 ), a soluble LAG-3Ig fusion protein, which is in
late-stage clinical development for the treatment of cancer. Immutep has a second in-house product candidate (IMP761) which is in pre-clinical development for the
treatment of autoimmune disease, and two clinical programs that are fully licensed to major pharmaceutical partners.
Immutep is listed on the Australian
Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
REVIEW OF OPERATIONS
The first half-year of FY2022 has seen Immutep report a significant body of supportive clinical results from efti from its Phase IIb AIPAC and Phase II TACTI-002 trials as well as from the investigator-initiated trial INSIGHT-004. Encouraging final Overall Survival (OS) from AIPAC, especially in prespecified sub-groups, have given the Company additional confidence efti can deliver a meaningful clinical improvement for cancer patients. The Company started a preparation process for a larger clinical trial (PIII, AIPAC-003) in metastatic breast cancer (MBC). Already the TACTI-003 Phase IIb trial, has advanced the company to late-stage development, with multiple indications being
evaluated to strengthen the Company s knowledge of and opportunity for efti.
Directors Report (Continued)
In July 2021, Immutep completed its share purchase plan (SPP) which opened to eligible shareholders the
previous month. The Company received total SPP funds of A$7,175,720, exceeding the targeted amount sought to be raised under the SPP of A$5m. The SPP followed a A$60m two-tranche institutional placement
(Placement) also conducted in June 2021, with the second tranche receiving shareholder approval at Immutep s EGM held in late July.
from the SPP and Placement are being applied to support the Company s ongoing and planned immuno-oncology clinical development programs, its pre-clinical program in autoimmune disease, manufacturing and
for general working capital purposes. Importantly, they have improved Immutep s financial flexibility and extended its cash runway to the end of calendar year 2023.
Regrettably, following the close of the half-year, Immutep announced Non-Executive Director Grant Chamberlain had
passed away suddenly and unexpectedly in late January 2022. Grant was a valued member of the Immutep team, having served on the Board since August 2017. The Company recognises the significant contribution he made, as well as his passion for Immutep
and extensive corporate and financial insights.
Clinical Trials with Eftilagimod Alpha
AIPAC - Phase IIb - Positive Final Data Reported
reported positive final Overall Survival (OS) data from its Phase IIb AIPAC clinical trial evaluating efti in MBC in November 2021 as a late breaker poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2021.
AIPAC is the Company s Phase IIb clinical trial evaluating efti in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy
combination. The trial was a randomised, double blinded, placebo-controlled clinical study in 227 HR+/HER2- metastatic breast cancer patients and was conducted across more than 30 clinical sites in Germany, UK, France, Hungary, Belgium, Poland, and
the Netherlands. The combination therapy aims to boost the body s immune response against tumour cells compared to chemotherapy plus placebo.
late-stage trial showed very encouraging OS data, including a statistically significant and clinically meaningful benefit in three prespecified subgroups representing a majority of patients. A survival benefit of +7.5 months was observed in patients
< 65 years, reflecting a > 50% improvement compared to the control group. A +19.6 month survival benefit was seen in patients with low monocytes, a benefit of > 150% compared to the control group. Lastly, a survival benefit of +4.2 months
was reported in luminal B patients, reflecting a > 33% benefit compared to the control group.
In addition, a statistically significant Quality of Life
preservation was demonstrated in the first 6 months from patients in the efti group in the total population. A statistically significant increase in peripheral CD8 T cells in patients in the efti group was observed and significantly correlated with
The results from AIPAC are particularly encouraging as HR+/HER2- metastatic breast cancer is typically a
non-immunogenic cancer and therefore less responsive to modern immune checkpoint inhibitor (ICI) therapies. As such, there continues to be a large unmet medical need in this population of patients.
These encouraging final results have formed the basis for the Company s planned AIPAC-003 clinical trial (see
AIPAC-003 - Phase III - Planned Registrational Trial
In October 2021, Immutep received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for efti which includes
AIPAC-003. Interactions with the EMA, US FDA and other regulators are ongoing. Feedback from competent authorities, along with insights from a rigorous engagement process with Key Opinion Leaders and other
stakeholders will inform about next steps for the program.
AIPAC-003 is Immutep s planned Phase III trial
evaluating efti in MBC. The study will be conducted across multiple countries and will be based on the Company s Phase IIb AIPAC trial, which reported encouraging final OS results in key patient subgroup populations in November 2021 (see
Directors Report (Continued)
TACTI-003 - Phase IIb - Late Stage Trial with Registration
Potential and Fast Track Designation
Based on robust data reported from TACTI-002 in 2nd line head and neck
squamous cell carcinoma (HNSCC) described below, Immutep is pursuing additional clinical development of efti in HNSCC in the commercially more relevant 1st line setting via TACTI-003.
TACTI-003 is a multi-centre, open label, randomized Phase IIb clinical study evaluating the combination of efti and
KEYTRUDA (pembrolizumab) in up to 154 patients with 1st line recurrent or metastatic HNSCC. The trial will take place across Australia, Europe, and the United States in up to 35 clinical
The new trial is being conducted under the terms of a second clinical trial collaboration and supply agreement with Merck & Co., Inc.,
Kenilworth, NJ, USA (known as MSD outside the United States and Canada) which Immutep entered into in March 2021. A similar clinical trial collaboration and supply agreement was previously executed between Immutep and MSD for the TACTI-002 trial.
In April 2021, the United States Food and Drug Administration (US FDA) awarded efti Fast Track
designation for 1st line recurrent or metastatic HNSCC.
In July 2021, Immutep completed all the necessary competent authority steps with the US FDA and
received IRB approval to commence TACTI-003 in the United States. Patient recruitment has commenced and is ongoing with 9 of approximately 154 patients currently enrolled into the trial at active clinical
sites. More sites are planned to be activated during first quarter of calendar year 2022.
The trial design for
TACTI-003 was presented to a scientific audience via a poster at the SITC 2021 conference in November 2021.
TACTI-002 (also designated KEYNOTE-798) - Phase II
TACTI-002 is Immutep s Phase II study evaluating the combination of efti with KEYTRUDA (pembrolizumab) in 189 patients with non-small cell lung cancer (NSCLC) in 1st and 2nd line (Parts A and B, respectively) and 2nd line HNSCC (Part C). The study is taking place at approximately 20 clinical sites in Australia, Europe, and the United
States. It is being conducted in collaboration with MSD and is called KEYNOTE-798 by MSD.
interim data from the 2nd line HNSCC patients (Part C) of TACTI-002 at the SITC 2021 conference. The results demonstrated encouraging antitumor activity. An encouraging Overall Response Rate (ORR) was
reported, with 29.7% of patients responding to the combination therapy of efti and pembrolizumab. In addition, a favourable duration and depth of responses was observed, with 5 Complete Responses and a minimum duration of response extended to > 9
months across all responding patients. The responses continue to be reported in both high and low PD-L1 expressors.
Recruitment was completed for all cohorts of the TACTI-002 trial during the half-year, with Immutep enrolling and
dosing the last patients in Part B (2nd line NSCLC) and in the expansion stage of Part A (1st line NSCLC).
Last updated: Feb 24, 2022