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IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2020 (previous corresponding period: half-year ended 31 December 2019) To be read in conjunction with the 30 J

Key Takeaway: Half-Year Financial Report (previous corresponding period: half-year ended 31 December 2019) To be read in conjunction with the 30 June 2020 Annual Report. In compliance with Listing Rule 4.2A. ASX/Media Release (ASX: Appendix 4D Half-Year Financial Report Results for Annou

Full Press Release Details

Half-Year Financial Report
(previous corresponding period: half-year ended 31 December 2019)
To be read in conjunction with the 30 June 2020 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 2020
Previous Reporting Period Half-year Ended 31 December 2019
Revenues Down 100 % to Nil
Other Income Down 29.7 % to 2,260,333
Total revenue and other income Down 78.6 % to 2,260,333
Loss after tax attributable to members Up 233 % to (19,844,146 )
Net loss for the period attributable to members Up 233 % to (19,844,146 )
The loss after tax for the half year ending 31 December 2020 of A$19,844,146 was significantly higher compared to
A$5,950,345 for the half year ending 31 December 2019, mainly due to a significant loss of A$8.1m from the net change in fair value of warrants and the absence of a milestone payment. The net change in fair value of warrants is a non-cash expense.
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 2020 7.22
As at 31 December 2019 3.15
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 2020 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 95 Pitt Street, 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
consolidated entity 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
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)
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
In the first half of the financial
year 2021, Immutep reported further encouraging results from its development program for efti, building on the product candidate s growing promise as an innovative immuno-oncology treatment in multiple cancers for patients.
More mature and encouraging Overall Response Rates (ORR) were reported from the Company s TACTI-002 Phase II
trial in 1st Line Non-Small Cell Lung Cancer patients (NSCLC) and 2nd Line Head and Neck Squamous Cell
Carcinoma patients (HNSCC). In addition, first encouraging Overall Survival results (OS) were reported from its AIPAC Phase IIb trial in metastatic breast cancer. Data from these trials were presented at world-leading cancer conferences during the
half year, validating the strength of the data.
These encouraging clinical results have prompted Immutep to scale up efti manufacturing and initiate two
new efti trials or trial extensions during the half year:
Additionally, Immutep s Chinese partner, EOC Pharma announced their new phase II study for efti in
metastatic breast cancer, following the encouraging AIPAC data.
Throughout the half year, Immutep continued its partner collaborations, including with
five major pharmaceutical companies throughout the half year: Novartis, GSK, MSD (i.e. Merck & Co (US)), Merck KGaA (i.e. Merck (Germany)) and Pfizer. It also entered into a new collaboration with LabCorp Corporation of America Holdings to
support the development of immuno-oncology products or services.
Immutep s operations continued with limited disruption as a result of the COVID-19 pandemic, with the Group focusing on protecting the health of patients recruited into its clinical trials and its employees.
Directors Report (Continued)
The Group is continuously monitoring the impact of COVID-19 on its
operations and on the carrying value of certain assets. The Group has worked closely with the regulators and clinical trial sites and implemented measures to safeguard our patients and employees. The Group developed a comprehensive response strategy
including establishing cross-functional response teams and implementing business continuity plans to manage the impact of the pandemic on our employees, patients, and our business. The Group managed to address these challenges without a material
impact on its clinical program and financial performance for the half year.
Patient recruitment was already well underway for the TACTI-002 and INSIGHT-004 trials and the Group s largest trial, AIPAC, was fully recruited when the COVID-19 pandemic was
declared. However, the extent to which the COVID-19 pandemic may impact the Group s business moving forward will depend on future developments, which are highly uncertain and cannot be predicted at this
time. The Group will continue to assess the impact on every level.
Clinical Trials for eftilagimod alpha
AIPAC (Active Immunotherapy PAClitaxel)
evaluates efti in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination. The trial is a randomised, double blinded, placebo-controlled clinical study with 226 evaluated HR+ metastatic breast cancer
patients and is taking place across in more than 30 clinical trial sites in Germany, the 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.
In December 2020, Immutep reported encouraging first OS data from AIPAC, based on approximately 60% of events. The data was
selected for a spotlight presentation at the San Antonio Breast Cancer Symposium 2020. It showed a promising and improving overall trend in OS in the trial total population. Specifically, a median survival benefit of +2.7 months was observed from
efti plus chemotherapy, compared to chemotherapy plus placebo.
In addition, a statistically significant OS benefit was observed in the efti group in pre-defined patient groups. A +7.1 month survival benefit was observed from efti with chemotherapy for patients under 65 years of age. They reported a median survival benefit of 21.9 months vs. 14.8 months in the
placebo group, marking close to a 50% improvement in survival. Similarly, a +9.4 month survival benefit from efti with chemotherapy was observed for patients with a low starting monocyte count. These patients reported a median survival of 22.4
months compared to 12.9 months for patients in the placebo group, equating to 74% longer survival.
Importantly, a statistically significant increase in
cytotoxic CD8 T cells was reported in patients treated with efti plus chemotherapy compared to chemotherapy and placebo. This increase correlates with prolonged OS in the efti group, indicating pharmacodynamic activity and proof of concept of
efti s mode of action. The combination of efti and paclitaxel chemotherapy was overall safe and well tolerated, further building upon efti s strong safety profile to date.
The collection of OS data is ongoing, and the proportion of patient events has now advanced to approximately 68%. Immutep is on track to report final OS and
ORR data by mid calendar year 2021.
TACTI-002 - Phase II
TACTI-002 (Two ACTive Immunotherapies) is a Phase II study evaluating the combination of efti with KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in 183 patients with second line HNSCC and NSCLC in first and second line.
The study is taking place at different clinical sites across Australia, Europe, the UK and US and is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and
Canada); MSD refers to the study as Keynote-798.
Throughout the half year, Immutep continued to report
consistently encouraging findings in different patient cohorts of TACTI-002. The data was presented at world-leading conferences: the ESMO Virtual Congress 2020 in September 2020 and at the Society for
Immunotherapy of Cancer (SITC) 35th Anniversary 2020 Annual Meeting in November as part of a late breaker poster presentation and poster walk for highly scored abstracts.
Directors Report (Continued)
At SITC, the Company reported more mature, interim ORRs for
1st line NSCLC (Part A) and 2nd line HNSCC (Part C). A 36% ORR was reported in patients with
1st line NSCLC and 36% ORR in patients with 2nd line HNSCC in the intent to treat population. Five patients (two with 1st line NSCLC and three with 2nd line HNSCC) reported a complete disappearance of all lesions, known as a Complete Response.
First data from patients with 2nd line NSCLC (Part B) who are
PD-1 resistant/refractory were also reported at SITC.
Following the encouraging data, Immutep and its partner MSD
have expanded the TACTI-002 study by 74 additional patients with 1st line NSCLC (Part A). The combination treatment of efti and pembrolizumab continues to
be safe and well tolerated with no new safety signals reported so far.
In November 2020, the Data Monitoring Committee confirmed a positive risk-benefit
assessment for Part B and recommended the opening of Stage 2 of Part B. Recruitment for the extension of Part A opened in late December 2020. In early January 2021, Immutep completed the recruitment of patients with 2nd line HNSCC (Part C) of the trial. Further data from TACTI-002 is expected in H1 calendar year 2021.
New Trial in 1st line HNSCC - Phase II
The data reported from 2nd line HNSCC patients (detailed above in
TACTI-002) was very robust and formed an excellent basis for Immutep to pursue additional clinical development in HNSCC.
In November 2020, Immutep announced plans for a new Phase II, randomised, controlled clinical study in approximately 160 1st line HNSCC patients. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical sites in the United States, Australia, and Europe.
CYTLIMIC is conducting clinical
trials evaluating efti as part of a cancer peptide vaccine, called CYT001, in patients with advanced or metastatic solid cancer. The cancer vaccine is comprised of the combination of a HSP70 derived peptide, a GPC3 derived peptide, Immutep s
IMP321 (efti) and Hiltonol.
Immutep s partnership with CYTLIMIC continued to progress well during the half year. CYTLIMIC has previously reported
positive results from its YNP01 Phase I clinical trial of CYT001 in early 2020 and interim results from a second Phase I study of CYT001, called YCP02, were reported in June 2020, showing tumour cell death and infiltration of T cells into tumour
regions in 6 out of 9 patients. CYTLIMIC is also collaborating with Chiba University in Japan to start a new Phase I trial of CYT001, called CRESCENT1.
Last updated: Feb 24, 2021