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IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Interim Financial Report For the Half-Year Ended 31 December 2019 (previous corresponding period: half-year ended 31 December 2018) To be read in conjunction with the 30 Jun

Key Takeaway: For the Half-Year Ended (previous corresponding period: half-year ended 31 December 2018) To be read in conjunction with the 30 June 2019 Annual Report. In compliance with Listing Rule 4.2A ASX/Media Release (ASX: IMM) Appendix 4D Interim Financial Report Results for Announ

Full Press Release Details

For the Half-Year Ended
(previous corresponding period: half-year ended 31 December 2018)
To be read in conjunction with the 30 June 2019 Annual Report.
In compliance with Listing Rule 4.2A
ASX/Media Release (ASX: IMM)
Appendix 4D Interim Financial Report
Results for Announcement to the Market
Current Reporting Period Half-year Ended 31 December 2019
Previous Reporting Period Half-year Ended 31 December 2018
Revenues Up From nil to 7,366,493
Loss after tax attributable to members Down 31.4 % to (5,950,345 )
Net loss for the period attributable to members Down 31.4 % to (5,950,345 )
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 2019 3.15
As at 31 December 2018 (restated) 4.68
Directors Report 2
Auditor s Independence Declaration 7
Interim financial report
Consolidated Statement of Comprehensive Income 8
Consolidated Balance Sheet 9
Consolidated Statement of Changes in Equity 10
Consolidated Statement of Cash Flows 11
Notes to the Consolidated Financial Statements 12
Directors Declaration 26
Independent Auditor s Review Report to the Members 27
Your directors are pleased to provide the following half-year report on Immutep Limited and its subsidiaries
(referred to hereafter as the Group or Immutep or the Company) for the half-year ended 31 December 2019.
The following persons were directors of Immutep up to the date of this report unless otherwise stated:
Principal Activities
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related
immunotherapeutic products for the treatment of 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.
Immutep s 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 fully 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
During the first half of financial
year 2020, Immutep continued to report encouraging data from its trials of its lead product candidate, eftilagimod alpha ( efti or IMP321 ). The Company is advancing its ongoing clinical trials and preparing to report decisive
data in the coming months, including the first data from its largest and most advanced clinical trial, AIPAC.
The Company reported first data from its TACTI-002 Phase II study and its INSIGHT-004 Phase I trial, along with final efficacy data from its Phase I TACTI-mel trial. These data
have built Immutep s confidence in the strong safety profile of efti and its encouraging efficacy. In addition, data from IMP761 for autoimmune disease was published in January 2020 in the Journal of Immunology, a peer reviewed publication.
Immutep continued its collaborations with five major pharmaceutical companies during the half year: Novartis, GSK, Merck & Co (MSD), Merck
(Germany) and Pfizer.
From July to August 2019, the Company completed a capital raise via its ASX listing raising approximately A$10 million, via a
Placement and a fully underwritten Entitlement Offer which included participation from directors and the entire executive management team. The proceeds from the financings are being used to continue the LAG-3
related programs, including the ongoing clinical development of efti and the development of IMP761. Importantly, the financing extended Immutep s cash runway beyond its significant data catalysts.
In November 2019, Immutep also completed a share consolidation, pursuant to which every 10 shares has been consolidated into 1 share. It was important that
Immutep consolidate its shares ahead of the multiple potential share price catalysts. By rationalising the shares on issue, investment in Immutep is expected to be more attractive to a broader range of institutional and professional investors and
other members of the investing public.
Directors Report (continued)
AIPAC (Active Immunotherapy
PAClitaxel) evaluates efti in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination. This combination is designed to boost the immune response against tumour cells compared to chemotherapy plus placebo.
The trial is a randomised, double blinded, placebo-controlled clinical study with 227 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
During the half year, the Company continued to advance the study towards the read-out of first
progression-free survival (PFS) and overall response rate (ORR) data, which is expected to be reported in March 2020.
This data will help Immutep to make
strategic decisions about efti s development with regard to partnering and regulatory pathways. AIPAC is potentially pivotal, meaning the final PFS data could serve as a basis to pursue regulatory approval pathways for efti with the European
Medicines Agency and the U.S. Food and Drug Administration.
If positive, the results could also help to validate an entirely new class of products in
immuno-oncology, antigen presenting cell activators, along with the pushing the gas concept. This would be an important medical achievement, with metastatic breast cancer just being the first indication of possibly many others to follow.
TACTI-002 (Two ACTive Immunotherapies) is Immutep s Phase II study evaluating the combination of efti with
KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous
cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC) in first and second line. It is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD
outside the United States and Canada).
Encouragingly, the requisite number of predefined patient responses were observed in stage 1 for Parts A (first
line NSCLC) during the period and C (second line HNSCC), post period. The Data Monitoring Committee recommended opening stage 2 recruitment for both these Parts, following its review of the preliminary safety and efficacy data. Accordingly, Immutep
is recruiting an additional 19 patients to both Part A and Part C, forming stage 2 of these Parts. Recruitment is ongoing for stage 1 of Part B (second line NSCLC).
In November 2019, Immutep reported the first preliminary safety and efficacy data from its TACTI-002 study. Patients
in stage 1 of Part A reported an encouraging preliminary Overall Response Rate (ORR) of 41%. This positive data was confirmed and even improved following the period end, with more mature data from TACTI-002
presented at the German Cancer Congress in February 2020. At the Congress, Immutep reported more mature positive interim data including an Overall Response Rate (ORR) of from 47% from stage 1 of Part A and 33% from stage 1 of Part C. In addition,
NSCLC responses were seen across all three PD-L1 expression level groups (< 1%, 1-49% and 50%). 59% of the NSCLC
patients are still under therapy with 7+ months, median PFS not yet reached.
TACTI-mel (Two ACTive Immunotherapies in melanoma) is Immutep s Phase I clinical trial evaluating efti with
MSD s KEYTRUDA in 24 patients with unresectable or metastatic melanoma that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy. This is the
same combination treatment that is being tested in Immutep s Phase II study, TACTI-002, as detailed above. TACTI-mel is a multi-centre, open label clinical trial
involving four cohorts of six patients per cohort.
In October 2019, Immutep reported positive final efficacy data for its
TACTI-mel trial. The data confirmed deep durable responses have been observed, with 12 patients (50%) having a decrease of 75% in the target lesions and 9
patients (38%) being treated for 12 months with pembrolizumab and efti. The results also determined the recommended dosage level for a Phase II trial which is 30mg of efti. This is the dosage level
currently used in the ongoing TACTI-002 Phase II trial.
Directors Report (continued)
The study confirmed that efti continues to have a favourable safety profile in combination with pembrolizumab
with no dose-limiting toxicities. Final safety data is expected to be reported in H2 FY20.
INSIGHT-004 is a Phase I study being conducted as an amendment to INSIGHT Phase I clinical trial (as
the 4th arm). The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany ( IKF ) is the sponsor of the clinical trial which is being conducted under the existing protocol of the ongoing INSIGHT. It evaluates
the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with advanced solid malignancies.
In December 2019, IKF completed the recruitment of the first cohort of 6 patients for INSIGHT-004. These patients are
receiving a standard dose of avelumab with efti (6 mg).
One patient has experienced a partial response to the combination treatment according to RECIST
from the first cohort and another patient has been reported as having stable disease, which is encouraging given the late disease stage and pretreatment of these patients. Importantly, no new safety signals or dose limiting toxicities have been
reported from the first cohort of patients.
More data from the study is expected to be reported in H2 FY20. Recruitment is ongoing for the second cohort
of 6 patients to receive the standard dose of avelumab, with a higher 30 mg dose of efti.
The Company is also executing a manufacturing scale up from 200L to 2,000L single-use bioreactors at the WuXi Biologics
manufacturing plant (Wuxi, China) in order to be better prepared for potential commercial manufacturing and additional registration trials in multiple indications for its lead product candidate, efti.
IMP761 preclinical development
IMP761 is an immunosuppressive agonist antibody to LAG-3. It is the first agonist antibody that targets the immune
checkpoint LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.
Throughout the half year, Immutep continued cell line development and the manufacturing steps for its preclinical candidate, IMP761. This follows the
encouraging results reported from the Company s preclinical studies in autoimmune disease studies of IMP761 in early 2019.
Following the end of the
period, IMP761 research results were published in the peer reviewed Journal of Immunology.
Clinical Development by Immutep s Partners
Novartis IMP701 Phase II
Novartis is Immutep s partner for the development of LAG525, which is a humanised LAG-3 antagonist antibody
derived from its IMP701 antibody.
In January 2019, Novartis commenced a fifth study of the product candidate, a Phase Ib clinical trial in triple
negative breast cancer. Across the five trials, LAG525 will be evaluated in a total of more than 1,100 patients, significantly enhancing the value of this product candidate.
GlaxoSmithKline (GSK) IMP731 Phase I
Immutep s partner for GSK2831781, which is derived from its IMP731 antibody.
Directors Report (continued)
GSK commenced its Phase II clinical study evaluating the product candidate in 280 ulcerative colitis patients
Last updated: Feb 24, 2020