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IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Interim Financial Report For the Half-Year Ended 31 December 2018 (previous corresponding period: half-year ended 31 December 2017) To be read in conjunction with the 30 Jun

Key Takeaway: Interim Financial Report (previous corresponding period: half-year ended 31 December 2017) To be read in conjunction with the 30 June 2018 Annual Report. In compliance with Listing Rule 4.2A ASX/Media Release (ASX: IMM) Appendix 4D Interim Financial Report Results for Annou

Full Press Release Details

Interim Financial Report
(previous corresponding period: half-year ended 31 December 2017)
To be read in conjunction with the 30 June 2018 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 2018
Previous Reporting Period Half-year Ended 31 December 2017
Revenues Down 100 % to
Loss after tax attributable to members Up 100.7 % to (8,678,492 )
Net loss for the period attributable to members Up 100.7 % to (8,678,492 )
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 2018 0.47
As at 31 December 2017 0.35
Directors Report 2
Auditor s Independence Declaration 7
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 2018.
The following persons were directors of Immutep 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 that is a leader in the development of 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 current 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 auto-immune 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 2019, Immutep was pleased to report strong progress with its clinical development program and its partnerships.
Encouraging data was reported from
its lead immunotherapy product candidate efti, with data from its phase I TACTI-mel clinical trial presented at leading industry conferences.
In July 2018, Immutep s investigational new drug (IND) application for efti was accepted by the US Food and Drug Administration (FDA). This marks the
achievement of a significant operational milestone for the Company as it enables the clinical evaluation of efti in US clinical trial sites for TACTI-002.
From a business development perspective Immutep has also delivered good momentum, adding a new clinical trial collaboration and supply agreement with Merck
KGaA, Darmstadt, Germany and Pfizer Inc to evaluate the combination of efti with avelumab. The Company now has ongoing collaborations with five major pharma companies: Novartis, GSK, Merck & Co (MSD), Merck (Germany) and Pfizer. It is
partnered with four of the world s top 10 pharmaceutical companies.
In December 2018, Immutep completed a US financing via its NASDAQ listing,
raising US$5.2 million (A$7.3 million) to continue Immutep s LAG-3 clinical development programs, including the AIPAC, TACTI-mel, TACTI-002, and INSIGHT clinical studies, as well as the preclinical development of its auto-immune disease product candidate, IMP761.
The financing was led by US specialist healthcare investor, Altium Capital, with participation from Leviathan Capital Partners. Importantly, this financing is
expected to extend the Company s cash runway into mid-2020.
AIPAC is Immutep s Phase IIb
clinical trial evaluating efti in combination with paclitaxel in metastatic breast cancer. During the half year, the Company advanced patient recruitment into the trial to reach a total of 193 participating patients (as at beginning of February
2019). This represents 85% of Immutep s 226-patient target.
The primary clinical end-point of the study is Progression-Free Survival (PFS) and the Company is expected to report first PFS data in 4th quarter of calendar year 2019.
Working in collaboration with MSD, TACTI-002 is the Company s Phase II clinical trial to evaluate the combination
of efti with MSD s KEYTRUDA (pembrolizumab) in up to 110 patients with three different types of cancers, head and neck squamous cell carcinoma ( 2nd line) and non-small cell lung cancer(1st and 2nd
line), across approximately 15 study centres in the U.S., Europe and Australia.
Throughout the half year, Immutep progressed its preparations for this
new trial, including regulatory permissions and clinical site selection. Activation of the first clinical trial site and commencement of patient recruitment is anticipated soon, with first data from TACTI-002
expected in 2nd half of calendar year 2019.
TACTI-mel is a Phase I clinical trial which is evaluating the combination of efti with MSD s KEYTRUDA (pembrolizumab) in unresectable or metastatic melanoma patients. The Company was pleased to report encouraging updated data, including the first data from Part B of the study where patients
commenced the combination from cycle 1, day 1 of pembrolizumab treatment, during the half year. The study is fully recruited.
As reported in November
2018, after 3 months of combination treatment, 3 out of the 6 patients participating in Part B experienced a partial response. This correlates to a 50% overall response rate (ORR) according to immune related response criteria (irRC). If the ORR
result calculation is restricted to evaluable patients (i.e. excluding one patient that did not have a CT scan), 3 out of 5 patients had a partial response, giving a 60% ORR. The current disease control rate for this Group is 66% (4/6).
The final data from TACTI-mel is on track to be reported later in 2019.
In September 2018, Immutep announced it would be commencing a new Phase I clinical trial under its new collaboration partnership with Merck KGaA, Darmstadt,
Germany and Pfizer Inc. The study will be called INSIGHT-004 and will evaluate the combination of efti with avelumab, a human
anti-PD-L1 antibody, in 12 patients with advanced solid malignancies.
INSIGHT-004 will be executed as an extension to the investigator-initiated INSIGHT clinical trial already underway by Immutep s partner, the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in
Frankfurt, Germany ( IKF ). Further details of the INSIGHT study are covered in the Partner section of this report.
Preparations have already
commenced for the necessary regulatory submissions that will to enable the Company to commence patient recruitment for INSIGHT-004 in 1st half of calendar
half year, the Company completed a preclinical study of its product candidate, IMP761, in auto-immune disease. The Company expects to report data from this study in early March 2019 at the European Crohn s and Colitis Organisation Conference in
Clinical Development by Immutep s Partners
Novartis IMP701 Phase II
Immutep s partner for the development of LAG525, which is derived from the Company s IMP701 antibody. During the half year, Novartis expanded its clinical development program for LAG525 and is now evaluating LAG525 in four active clinical
trials. A fifth trial expected to commence soon. In total, LAG525 will now be evaluated in more than 1,100 patients.
GlaxoSmithKline IMP731 Phase I
continuing the development of GSK2831781 (derived from Immutep s IMP731 antibody) with an expected proof of concept study in ulcerative colitis. According to GSK the proof of concept is anticipated in 2020. It follows the completion of its
Phase I study evaluating GSK2831781 in psoriasis in March 2018.
After the reporting period, in early January 2019, Immutep formalised its long-standing relationship with CYTLIMIC, signing a clinical trial collaboration
agreement, a supply agreement and a service agreement with CYTLIMIC Inc.
Under the Agreements, CYTLIMIC pays Immutep an upfront payment of US$500,000 and
up to US$4.5 million in milestone payments, as well as covering the costs of the clinical trials. Importantly, Immutep retains complete exclusivity over its core patent rights covering its own clinical development programs and those it is
conducting in conjunction with its other collaboration partners.
EOC Pharma IMP321 Phase I
EOC Pharma, an oncology focused affiliate of Eddingpharm, is Immutep s Chinese licensee for efti. In October 2018, it commenced its clinical development
program for efti in China via a Phase I study in metastatic breast cancer. The first patient has been safely dosed and further updates are expected from EOC Pharma in calendar year 2019.
INSIGHT is a collaborative Phase
I study being conducted and directed by Immutep s partner, IKF in Germany. It investigates the potential for efti in different settings in terms of route of administration and indications and 13 patients have now been enrolled into the study.
Patient recruitment is ongoing and data is expected to be reported by IKF in calendar year 2019.
Intellectual Property
During the half year, two new European patents were granted for Immutep. These patents protect efti in combination with a
PD-1 or PD-L1 inhibitor and in combination with therapeutic antibodies for treating cancer. In addition, the Company was granted a Canadian patent for its IMP731
antibody providing broad protection for the antibody and use of the antibody for treating or preventing organ transplant rejection or treating a T-cell mediated autoimmune disease.
Following a very productive half year
period, Immutep is preparing for a data heavy calendar year 2019, with multiple value enhancing clinical data sets to be reported throughout the year. The Company plans to report:
These data will support Immutep s business development efforts which continue to be active into calendar
year 2019. In addition, Immutep will continue working with its collaboration partners for its partnered clinical programs.
Immutep s financial position was strengthened in December 2018 with the U.S. capital raise of US$5.2 million (approximately A$7.3 million), the
Company s second capital raise using American Depository Shares (ADS) since listing on NASDAQ in 2012. Strategically, it provided important financial headroom to fund existing clinical development programs and brought U.S. specialist healthcare
institutional investors onto the share register.
In September and October 2018, Immutep received US$ 1.05 million (approximately A$1.46 million)
from the exercising of ADS warrants which were issued in July 2017.
In August 2018, Immutep received a 1.22 million (approximately A$1.94
million) cash rebate from the French Government for the research and development activities conducted in Europe during the calendar year 2017.
December 2018, the consolidated entity had total funds of A$26.0 million comprising cash in hand at bank of A$7.6 million and short term deposits of A$18.4 million. Based on our current projections, we estimate that our cash reach
extends to middle of calendar year 2020.
Auditor s independence declaration
A copy of the auditor s independence declaration as required under section 307C of the Corporations Act 2001 is set out on page 7. This report is made in
Last updated: Feb 28, 2019