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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 2021 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 2021 Previous corresponding period: Year ended 30 June 2020 FY 2020 FY 2021 Revenue from ordinary activities Down 7,48

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 2021
Previous corresponding period: Year ended 30 June 2020
FY 2020 FY 2021
Revenue from ordinary activities Down 7,486,444 to Nil
Other income Down 9,013,524 to 3,968,133
Loss from ordinary activities after tax attributable to the owners of Immutep Limited Up (13,468,232 ) to (29,902,624 )
Loss for the period attributable to the owners of Immutep Limited Up (13,468,232 ) to (29,902,624 )
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 $29,902,624 (30 June 2020: loss of $13,468,232).
Explanation of the above information:
The increase in loss after tax for the financial year ended 30 June 2021 was mainly attributable to the following:
Removing the impact of this non-cash item results in a loss after tax for FY2021 of ~$21.24M.
For other details of the current year results, refer to the Review of Operations and Activities.
Net tangible asset backing per ordinary security Reporting period Previous corresponding period
8.1 Cents 3.7 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.
Details of attachments (if any):
The annual report for the year ended 30 June 2021 is attached.
Date: Monday, 30th August 2021
Company Secretary
This report is based on financial statements which have been audited.
CORPORATE DIRECTORY 1
CHAIRMAN S LETTER 2
REVIEW OF OPERATIONS AND ACTIVITIES 4
DIRECTORS REPORT 11
AUDITOR S INDEPENDENCE DECLARATION 26
CORPORATE GOVERNANCE STATEMENT 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 74
INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF IMMUTEP LIMITED 75
SHAREHOLDER INFORMATION 81
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
Ms Indira Naidu
Registered office & Level 12
principal place of business 95 Pitt Street
Sydney NSW 2000
+61 2 8315 7003
Share Registry Boardroom Pty Ltd
Grosvenor Place
Level 12, 225 George Street
Sydney, NSW 2000
+61 2 9290 9600
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
Dear Fellow Shareholder:
I m delighted to present
Immutep s annual report for the financial year 2021.
Immutep is a global leader in the development of LAG-3
immunotherapeutic products for cancer and autoimmune disease, two large and growing markets where new therapies are urgently needed for patients. The year has seen us report exciting clinical results, deepen our partnerships with large
pharmaceutical partners and expand our trial pipeline considerably.
We have also witnessed the validation of the
LAG-3 immune control mechanism in our industry this year. Specifically, the interaction between LAG-3 and the MHC class II (its main ligand) was validated as a
therapeutic mechanism for regulating the body s immune system to fight cancer by a major pharmaceutical company when it announced encouraging Phase III trial results.
Today Immutep is positioned to lead this promising LAG-3 therapeutic space, having more
LAG-3 programs under development than any other biotech or pharma. We have four product candidates based on LAG-3. First, our lead product candidate, eftilagimod alpha
(efti), is now advancing to late-stage clinical development for cancer treatment. Two other clinical candidates are exclusively worldwide licensed to our pharmaceutical partners, Novartis and GSK. A fourth candidate, IMP761, is in pre-clinical development for autoimmune disease. Importantly, all these products have different mechanisms of action, so each represents an independent risk and efficacy profile for clinical development and
regulatory approval.
Throughout the year, Immutep has reported encouraging results from its clinical trials of efti which have been selected for
presentation at leading scientific conferences across the globe. Our most advanced clinical trial is AIPAC, a Phase IIb study. which reported encouraging survival data in metastatic breast cancer patients when efti was administered in combination
with the chemotherapy agent, paclitaxel. From TACTI-002, our Phase II study in non-small cell lung cancer and head and neck squamous cell carcinoma (HNSCC), we reported
positive interim results showing the combination therapy of efti and KEYTRUDA (pembrolizumab), an anti-PD-1
inhibitor, delivers a very favourable overall response rate, as well as other positive results and a good safety profile.
Lastly, we reported encouraging
final results from the Phase I INSIGHT-004 study where promising activity signals were demonstrated in patients with different solid tumours from the combination of efti and BAVENCIO (avelumab), a monoclonal antibody. In both TACTI-002 and
INSIGHT-004, some deep and durable responses were seen in patients who typically do not respond to immune checkpoint therapy, giving us hope that efti is able to turn cold tumours to
hot tumours where the immune system switches back on to fight the cancer.
Our clinical results have proven their strength in attracting and
deepening partnerships with large pharmaceutical companies which share our excitement about the potential of LAG-3. Immutep formed a second collaboration with MSD this year for a new Phase IIb trial in HNSCC,
called TACTI-003, which evaluates efti in combination with pembrolizumab. Similarly, we are collaborating again with Merck KGaA for the new INSIGHT-005 Phase I/IIa
clinical study to evaluate efti in combination with bintrafusp alfa, an investigational bifunctional fusion protein immunotherapy being jointly developed by Merck KGaA and GlaxoSmithKline. Additionally, we entered into a new licence and
collaboration agreement with LabCorp to support their development of immuno-oncology products or services. These new collaborations build on our ongoing partnerships with GSK, Novartis, EOC Pharma and CYTLIMIC.
The continued strength of our efti results in multiple cancer settings and in many different strategic therapeutic combinations has also given us confidence
to commence the planning of a Phase III trial in metastatic breast cancer. Not only does this planned late-stage study strengthen our position for business development discussions, but, if the results are positive, it will also provide us with
registration data to submit to the relevant competent authorities. Our efti pipeline has also been expanded with other new trials, including the first triple combination therapy of efti, chemotherapy and anti-PD-1 therapy.
We have begun to scale up the manufacturing process for efti to produce the greater
quantities of efti needed for our larger trials and for potential commercialisation. The major scale up steps are taking place throughout calendar year 2021 and are progressing well.
We undertook two financings during the past twelve months and were delighted to be supported by multiple new and existing institutional investors from
Australia and offshore. In November 2020, Immutep successfully raised A$29.6 million via a placement and then in June 2021, we conducted a two-tranche placement and share purchase plan which raised a
total of A$67.2 million, with tranche two completed following approval by shareholders at an EGM in July 2021.
As well as supporting our ongoing
efti trials, the funds raised enable us to significantly expand our clinical development and manufacturing programs and to advance our pre-clinical program in autoimmune disease. Importantly, the financings
expand our programs and also extend our cash runway to the end of calendar year 2023.
On behalf of the Board, I would like to thank our loyal
shareholders who have supported Immutep as it stepped onto the world stage this year as the leading LAG-3 pure-play biotech company. I am proud of the work that the management team has accomplished over the
years to bring us to this point and am equally excited about what lies ahead.
Immutep is transforming into a late-stage biotech as it continues to
progress efti towards the path to registration whilst also strengthening its business development position. Our AIPAC trial is on track to report final data in the second half of calendar year 2021 and we expect to report further interim results
from TACTI-002 in calendar year 2021 or early calendar year 2022 and initial interim results from TACTI-003 in calendar year 2022.
We look forward to reporting our progress to you as we enter this exciting phase.
REVIEW OF OPERATIONS AND ACTIVITIES
PRINCIPAL 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. 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.
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 later-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 financial year 2021 was very
important for Immutep as the LAG-3 field made major advancements and as Immutep prepared for the expansion of its pipeline of efti trials to become a late-stage biotech. The Company continued to report
encouraging efficacy results for efti in multiple clinical trials including AIPAC (Phase IIb), TACTI-002 (Phase II) and INSIGHT-004 (Phase I).
Efti is showing promise as a therapy to boost the body s immune response against cancer cells and continues to be safe and well tolerated, giving the
Company confidence to advance it into registrational trials.
During the year, Immutep embarked on new clinical trials of efti and announced new
collaborations with leading pharmaceutical companies and academic institutions. The Company s new trials are TACTI-003 (Phase IIb) which is being conducted under a second collaboration agreement with
pharmaceutical partner, Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), INSIGHT-005 (Phase I/IIa) under a new collaboration with Merck KGaA, and
INSIGHT-003 (Phase I). The INSIGHT-003 and INSIGHT-005 trials are part of the Investigator-Initiated Trial ( IIT )
INSIGHT clinical trial platform.
During the financial year, Immutep also announced new or continuing collaborations with Monash University and Cardiff
In preparation for 2,000L scale manufacturing and potential registration, Immutep commenced the scale up of GMP manufacturing for efti. It
also strengthened its intellectual property position for its technologies, with new patents being granted for efti, IMP761 and leramilimab (otherwise known as LAG525, licensed to Novartis) during the financial year.
With the support of new and existing shareholders, Immutep completed two financings during the financial year. In November 2020 Immutep successfully raised
A$29.6 million via a placement which was supported by institutional investors in Australia and offshore.
Later in June 2021, the Company conducted a
two-tranche placement and share purchase plan which raised a total of A$67.2 million. Tranche two completed in July 2021 following approval by shareholders at an EGM. Multiple existing institutional
shareholders from Australia and offshore participated in this placement, including new substantial shareholder, Fidelity International.
supporting Immutep s ongoing and planned immuno-oncology clinical development programs, its pre-clinical program in autoimmune disease and for general working capital purposes. The financings have
significantly improved Immutep s financial flexibility and extended its cash runway to the end of calendar year 2023.
REVIEW OF OPERATIONS AND ACTIVITIES
Clinical Trials with Eftilagimod Alpha
AIPAC 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 227 evaluated HR+/HER2- metastatic breast cancer patients and is taking place across more than 30 clinical trial 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.
Last updated: Sep 1, 2021