Recent Updates
Recently added Catalysts
IMMP

Immutep Limited Preliminary final report APPENDIX 4E PRELIMINARY FINAL REPORT 1. Company details Name of entity: Immutep Limited ABN: 90 009 237 889 Reporting period: Year ended 30 June 2019 Previous corresponding period

Key Takeaway: Preliminary final report PRELIMINARY FINAL REPORT Name of entity: Immutep Limited ABN: 90 009 237 889 Reporting period: Year ended 30 June 2019 Previous corresponding period: Year ended 30 June 2018 Revenue from ordinary activities Down 95 % to $ 139,782 Other income

Full Press Release Details

Preliminary final report
PRELIMINARY FINAL REPORT
Name of entity: Immutep Limited
ABN: 90 009 237 889
Reporting period: Year ended 30 June 2019
Previous corresponding period: Year ended 30 June 2018
Revenue from ordinary activities Down 95 % to $ 139,782
Other income Up 56 % to $ 7,349,622
Loss from ordinary activities after tax attributable to the owners of Immutep Limited Up 44 % to ($ 18,343,984 )
Loss for the period attributable to the owners of Immutep Limited Up 44 % to ($ 18,343,984 )
Dividends There were no dividends paid or declared during the current financial period
Comments The loss of the consolidated entity after providing for income tax amounted to $18,343,984 (30 June 2018: $12,746,020)
Explanation of the above information:
The higher loss after tax for FY2019 of A$18,343,984 compared to A$12,746,020 for FY2018, was mainly due to the increased number of clinical trials and
associated R&D expenses of A$6.6 m.
For other details of the current year results, refer to the Review of Operations.
Net tangible asset backing per ordinary security Reporting period Previous corresponding period
0.22 Cents 0.50 cents
Preliminary final report
no dividends paid or declared during the current financial period
Previous corresponding period
There were no dividends paid or declared during the previous financial period.
This report is based on financial statements which have been audited.
Details of attachments (if any):
The annual report for the year ended 30 June 2019 is attached.
Date: Tuesday, 20th August 2019
Company Secretary
CORPORATE DIRECTORY 1
CHAIRMAN S LETTER 2
REVIEW OF OPERATIONS 4
DIRECTORS REPORT 10
AUDITOR S INDEPENDENCE DECLARATION 27
FINANCIAL STATEMENTS 28
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME 29
CONSOLIDATED BALANCE SHEET 30
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY 31
CONSOLIDATED STATEMENT OF CASH FLOWS 32
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS 33
DIRECTORS DECLARATION 71
INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF IMMUTEP LIMITED 72
SHAREHOLDER INFORMATION 78
Directors
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)
Company Secretaries Ms Deanne Miller
Mr Tom Bloomfield
Registered office & Level 12
principal place of business 95 Pitt Street
Sydney NSW 2000
Share Registry Boardroom Pty Ltd
Grosvenor Place
Level 12, 225 George Street
Sydney, NSW 2000
Auditor PricewaterhouseCoopers
One International Towers Sydney, Watermans Quay
Barangaroo, NSW 2000
Banker National Australia Bank Ltd
Kew Branch
Melbourne, Victoria 3000
Stock exchange listings Immutep Limited shares are listed on the:
Australian Securities Exchange (ASX code: IMM), and NASDAQ Global Market (NASDAQ code: IMMP)
Website address www.immutep.com
As your Chairman, I m delighted to
report our good progress for the financial year 2019.
Immutep continues to cement its position as a leader in the development of immunotherapeutic LAG-3 related products for the treatment of cancer and autoimmune disease. Our technologies stem from our strong intellectual property around the LAG-3 immune control
During the financial year, we are very pleased to have achieved good operational progress and are confident that we have laid the foundations
for the meaningful clinical results that we expect to report in the new financial year, FY20.
Shaping our work has been a strong focus on the key value
creation milestones ahead for our lead product candidate, eftilagimod alpha (efti or IMP321).
Positive interim clinical results from our Phase I TACTI-mel study in metastatic melanoma patients were reported throughout the financial year. The interim results indicate that efti has a favourable safety profile as well as having shown encouraging efficacy thus
Reaching an important milestone, we completed the recruitment of 227 patients to our largest and most advanced study, AIPAC, a Phase IIb study in
metastatic breast cancer (HER2-negative/ Hormone Receptor positive (HR+)). This has significantly derisked the trial from an operational perspective. The team is now working towards first efficacy data from this potentially pivotal trial, which we
expect to report in the first quarter of calendar year 2020.
There is an urgent need to develop new therapies for metastatic breast cancer patients, who
have a median life expectancy of approximately 2 years when they start first line chemotherapy. If the results from AIPAC are positive, efti could potentially help the approximately 250,000 patients who are diagnosed each year with HER2 negative and
HR positive1 breast cancer and receive chemotherapy.
Expanding our clinical trial pipeline, we
commenced two new clinical trials during the year: TACTI-002, a Phase II study in head and neck squamous cell carcinoma and non-small cell lung cancer, and INSIGHT-004, an extension to the running INSIGHT study in advanced solid tumours. Both these trials will add to our clinical understanding of efti and its potential in multiple cancer settings and different
Another key milestone achieved during the financial year was the approval of our first Investigational New Drug (IND) application by the US
Food and Drug Administration (FDA) for efti. The IND was crucial to the start of our new Phase II TACTI-002 study in the US.
Our business development efforts have also been rewarding. We entered into a new clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt,
Germany and Pfizer Inc., to evaluate the combination of efti with avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies (INSIGHT-004). The company also entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC Inc. where efti is utilised as part of a cancer vaccine.
Immutep is now collaborating with five major pharmaceutical companies: Novartis, GSK, Merck & Co (MSD), Merck (Germany) and Pfizer.
Each new collaboration or license agreement with a large pharmaceutical company signals encouraging validation of our innovative LAG-3 technologies, noting preparations and checks that each pharmaceutical company completes before entering any partnership.
Outside our focus on efti, we were also pleased to report encouraging preclinical results for IMP761, demonstrating its immunosuppressive activity in vivo and
supporting its advancement towards clinical trials in autoimmune diseases. We hope to report further updates on our plans for IMP761 during the 2020 financial year.
Immutep continued to receive strong investor support during the financial year, raising approximately
US$5.2million (A$7.2million) via its NASDAQ listing. We were pleased to welcome Altium Capital, a US-based healthcare investment fund to our share register through this capital raise.
Following the end of the financial year, we also completed a capital raise via our 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 extended our cash runway and are being used to continue our LAG-3 related programs, including the ongoing clinical development of efti and the preclinical development of IMP761.
The year ahead will be very busy and exciting for Immutep. With much of the ground work already completed by the team, we are already preparing to report the
first data from our Phase IIb AIPAC study, as well as final data from our Phase I TACTI-mel study, first data from our Phase II TACTI-002 study and the first data from
our Phase I INSIGHT-004 study.
I would like to thank the Immutep team for their dedication and ongoing hard work
to deliver these clinical results in the coming months. Thank you, also to our loyal shareholders for continuing to support us as we work towards these value creation milestones.
REVIEW OF OPERATIONS
On behalf of the directors and management of Immutep, it is my pleasure to report on Immutep s operations for the 2019 financial year.
The financial year 2019 has been a year of growth and good progress for Immutep, clinically and with partnerships.
Building on its clinical trial pipeline, the Company commenced two new clinical trials during the year: TACTI-002, a
Phase II study in head and neck squamous cell carcinoma(2nd line) and non-small cell lung cancer (1st and 2nd line), and
INSIGHT-004, an extension to the existing investigator initiated INSIGHT study in advanced solid tumours. Both these trials will enhance our understanding of efti, its value and its application in new cancer
settings and in different combinations (anti-PD1 and anti-PDL-1).
The Company reported positive interim results from its Phase I TACTI-mel study in melanoma patients, after completing
recruitment for the trial in August 2018. Encouraging preclinical results were also reported for IMP761 in September 2018, demonstrating its immunosuppressive activity in vivo and supporting its progress towards clinical trials in autoimmune
diseases. These results were presented in more detail at the ECCO conference in March 2019.
Additionally, Immutep completed in June 2019 the recruitment
of 227 patients to its Phase IIb AIPAC study in metastatic breast cancer and is expecting to report first efficacy data from this potentially pivotal trial in Q1 of calendar year 2020.
During the financial year, Immutep received approval of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) for efti
in July 2018. The IND enables efti to be tested by US clinical investigators participating in the Company s TACTI-002 Phase II study, making it vital to start the trial in the US.
Marking strong business development progress by the team, Immutep entered into a new clinical trial collaboration and supply agreement with Merck KGaA,
Darmstadt, Germany and Pfizer Inc. in September 2018. The collaboration will evaluate the combination of efti with avelumab, a human anti-PD-L1 antibody, in patients
with advanced solid malignancies.
Following this new partnership, Immutep is now collaborating with five major pharmaceutical companies: Novartis, GSK,
Merck & Co (MSD), Merck (Germany) and Pfizer.
The Company also formalised its collaboration with CYTLIMIC in January 2019 and consequently, efti
is now being evaluated as part of three different combination therapy types: as part of a therapeutic cancer vaccine, as a chemo-immunotherapy and in an IO combination, demonstrating its broad therapeutic potential.
In December 2018, the Company raised approximately US$5.2million (A$7.2million) through a registered direct offering of 260,000,000 ordinary shares
represented by 2,600,000 American Depositary Shares (ADSs) via its NASDAQ listing and issuing via a private placement warrants to purchase up to 208,000,000 ordinary shares represented by 2,080,000 ADSs.
Subsequent to the year end, Immutep completed a capital raise via the ASX, raising A$4 million in a placement to institutional investors and
approximately A$6 million in a fully underwritten Entitlement Offer. The total capital raised of A$10.0 million will be used to continue Immutep s LAG-3 related programs, especially the ongoing
clinical development of efti, as well as the preclinical development of IMP761, and for general corporate purposes.
The Company s cash runway is
expected to extend to the end of calendar year 2020 with the inclusion of an anticipated milestone payment to be received within this cash reach period. However, should receipt of this anticipated milestone be delayed, the Company may
correspondingly delay incurring expenses on certain value enabling clinical and manufacturing activities for efti.
Immutep s Clinical Trials
AIPAC is Immutep s largest and
most advanced clinical trial of efti and is potentially pivotal, meaning it could serve as a basis to pursue the appropriate regulatory approval pathways for efti with, for example, the European Medicines Agency (EMA) or the US FDA, subject to
sufficient data from the trial and regulatory interactions.
AIPAC (Active Immunotherapy PAClitaxel) is a Phase IIb clinical trial in HER2-negative/ HR
positive metastatic breast cancer. The study evaluates the combination efti and a taxane-based standard of care chemotherapy, called paclitaxel. This combination is aimed at boosting the immune response against tumour cells compared to chemotherapy
Patient recruitment into the trial built steadily throughout the financial year, resulting in full trial recruitment comprising 227 patients
in June 2019. These patients are participating in more than 30 clinical trial sites across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands.
The primary clinical end-point of the study is Progression-Free Survival (PFS). The
read-out of PFS data is expected to be reported together with the overall response rate in Q1 of calendar year 2020.
TACTI-002 - Phase II
TACTI-002 (Two ACTive Immunotherapies) is Immutep s Phase II clinical trial in patients with three different solid
cancers. It is being conducted in collaboration with the Company s partner, Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada).
The study will evaluate the combination of efti with MSD s Keytruda (pembrolizumab), a PD-1 blocking antibody, in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. This is the same
combination therapy being explored in the Company s TACTI-mel trial, which has reported consistently positive interim clinical results throughout the financial year 2019.
In March 2019, the first patient was enrolled and safely dosed with the combination of Keytruda
pembrolizumab) and efti in Spain and the trial now has 26 patients participating, including full enrolment (17 patients) into the first cohort of the first line non-small cell lung cancer (NSCLC) arm (Part A).
Last updated: Aug 21, 2019