Full Press Release Details
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Preliminary final report
PRELIMINARY FINAL REPORT
| Name of entity: | Immutep Limited | |||||
| ABN: | 90 009 237 889 | |||||
| Reporting period: | Year ended 30 June 2020 | |||||
| Previous corresponding period: | Year ended 30 June 2019 |
| FY 2019 | FY 2020 | |||||||||||
| Revenue from ordinary activities | Up | 139,782 | to | 7,486,444 | ||||||||
| Other income | Up | 7,349,622 | to | 9,013,524 | ||||||||
| Loss from ordinary activities after tax attributable to the owners of Immutep Limited | Down | (18,343,984 | ) | to | (13,468,232 | ) | ||||||
| Loss for the period attributable to the owners of Immutep Limited | Down | (18,343,984 | ) | to | (13,468,232 | ) |
There were no dividends paid or declared during the current financial period.
consolidated entity after providing for income tax amounted to $13,468,232 (30 June 2019: $18,343,984).
Explanation of the above information:
The loss after tax of $13,468,232 for the financial year 30 June 2020 decreased substantially compared to the previous corresponding period loss of
$18,343,984. This decrease was mainly attributable to the significant increase of licensing income. Licensing revenue increased significantly from $140K in FY 2019 to $7.49 million in FY 2020, mainly attributed to the GSK milestone payment of
GBP 4 million ($7.49 million) received in this fiscal year related to the first patient being dosed in GSK s Phase II clinical trial evaluating GSK2831781 in ulcerative colitis.
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* | ||||||
| 3.7 Cents | 2.2 cents |
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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 2020 is attached.
| Date: Tuesday, 25th August 2020 | ||||||
| Company Secretary |
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| CORPORATE DIRECTORY | 1 | |||
| CHAIRMAN S LETTER | 2 | |||
| REVIEW OF OPERATIONS AND ACTIVITIES | 4 | |||
| DIRECTORS REPORT | 9 | |||
| AUDITOR S INDEPENDENCE DECLARATION | 25 | |||
| FINANCIAL STATEMENTS | 26 | |||
| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME | 27 | |||
| CONSOLIDATED BALANCE SHEET | 28 | |||
| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | 29 | |||
| CONSOLIDATED STATEMENT OF CASH FLOWS | 30 | |||
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS | 31 | |||
| DIRECTORS DECLARATION | 74 | |||
| INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF IMMUTEP LIMITED | 75 | |||
| SHAREHOLDER INFORMATION | 80 |
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| 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 |
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Dear Fellow Shareholder,
It s my pleasure to present Immutep s annual report for the financial year 2020.
Immutep is focused on improving the lives of patients with cancer and autoimmune disease by leveraging the body s immune system. We are leaders in the
development of immunotherapeutic products stemming from the LAG-3 immune mechanism, which was discovered by our CMO and CSO Prof Fr d ric Triebel.
We have four product candidates that are advancing well, despite the global challenges in protecting our trial patients and our employees precipitated by the
COVID19 pandemic. These product candidates are being evaluated in 12 active clinical trials and almost 2,000 patients across the globe. Two of them, IMP731 (from which GSK2831781 is derived) and IMP701 (from which LAG525 is derived), are already
licensed out to global pharmaceutical companies GSK and Novartis, respectively. During the year we collected $7.7 million in receipts from customers, mainly due to the GSK milestone payment of 4 million.
Our lead product candidate is eftilagimod alpha (efti or IMP321) which is in clinical development for a range of cancer indications. Our other retained
program is IMP761, which is in preparations for GMP manufacturing in autoimmune diseases after successful preclinical results.
Cancer and autoimmune
diseases are large and growing markets where new therapies are urgently needed for patients. The global oncology drugs market is expected to reach an estimated US$176.5 billion by 20251 and
the global autoimmune treatment market is expected to grow to US$149.4 billion by 20252.
Immutep deepened its knowledge of efti through multiple trial readouts this financial year. Our largest clinical trial of efti, called AIPAC (Phase IIb)
combines it with paclitaxel in breast cancer patients. In this study, efti delivered better progression free survival (PFS) compared to the placebo group at the 6-month landmark. While a number of specific
patient subgroups showed good results from the combination therapy in AIPAC, we had hoped for stronger overall PFS results. Unfortunately, this impacted the Company s share price at a time where the global markets were also reacting with
volatility to the uncertainty of the emerging COVID19 pandemic.
When efti is combined with pembrolizumab in our
TACTI-002 study (Phase II), encouraging results have also been achieved so far in head and neck squamous cell carcinoma and non-small cell lung cancer. These results
were presented to the scientific community at ASCO in June 2020. The same combination therapy with pembrolizumab was tested in patients with melanoma in TACTI-mel (Phase I), reporting deep and durable
responses which were presented in October last year. The INSIGHT-004 (Phase I) studying the combination of efti with avelumab showed encouraging early efficacy signals in patients. Importantly, efti continues
to be in general comparably safe and well tolerated in all these trials.
Each of these trials tests efti when administered to patients in combination
with either an approved chemotherapy agent or another immunotherapeutic. This has been a deliberate strategy that focuses on improving patient outcomes by using efti to push the gas of the immune system by stimulating cancer-fighting T
cells, while also combating cancer with an approved therapy.
This strategy also enables us to demonstrate efti s potential to pharmaceutical
companies that are aligned with our mission to enhance patient outcomes, helping us to form strategic collaborations. Immutep is already partnered with five of the world s major pharmaceutical companies: Novartis, GSK, Merck & Co
(MSD), Merck (Germany) and Pfizer. In addition, we continue to collaborate with CYTLIMIC (NEC s drug discovery business) and our Chinese licensee for efti, EOC Pharma.
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CHAIRMAN S LETTER (CONTINUED)
During the year, we were very pleased to have the continued support of new and existing
institutional and sophisticated investors as we raised A$12 million via a placement in April 2020 and A$10 million from a placement and fully underwritten Entitlement Offer in July 2019. The funds are supporting our LAG-3 clinical programs in cancer and autoimmune disease. The financings extended our cash runway to the end of calendar year 2021, beyond many anticipated clinical trial data read outs.
Results from multiple trials of efti will be reported throughout the coming financial year, which could further expand the intrinsic value of this promising
asset. AIPAC will report overall survival data by the end of calendar year 2020 and more mature data will come from TACTI-002 and INSIGHT-004 throughout calendar year
I am pleased with the progress made by our Company this year and wish to pass on the Board s thanks to the whole Immutep team for their
continued diligence and passion through what have been challenging and unprecedented times. I also extend our thanks to our loyal shareholders who have continued to support us and share our commitment to bringing new therapies to market to improve
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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
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 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
Throughout the financial year 2020,
Immutep advanced the development of its lead product candidate, efti and reported data from its trials. It reported supportive efficacy data from its largest study, AIPAC (Phase IIb), in breast cancer patients. This included progression-free
survival (PFS) data that showed that efti provided an improvement for patients compared to a placebo group at the 6-month landmark. While we are very pleased by the results from some of the pre-defined patient subgroups, we had hoped for better overall results in terms of PFS. The results were, unfortunately, reported at a time of relatively high market uncertainty and volatility related to the COVID19
pandemic. We look forward to reporting Overall Survival results by the end of 2020.
Encouraging first and more mature interim results have also been
reported for Immutep s Phase II clinical trial, TACTI-002. A first group of patients participating in the trial with 1st line non-small cell lung cancer (NSCLC) have reported a median PFS estimate of more than 9 months, which is a very encouraging interim result for patients with such advanced cancer. Immutep also reported the first
Complete Response (complete disappearance of target lesion) from a patient with 2nd line head and neck squamous cell carcinoma (HNSCC). Both the AIPAC and
TACTI-002 trials are ongoing.
In addition, Immutep reported positive final efficacy data for its Phase I TACTI-mel trial during the financial year. These results showed deep durable responses to the combination treatment in patients with melanoma. In this trial, half of patients had a decrease of 75% in the target lesions when treated with pembrolizumab and efti.
Immutep continued to work with its
collaborators, including five major pharmaceutical companies throughout the financial 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 Immutep s directors and the entire executive management team. In April 2020, the Company raised a further A$12 million via a Placement supported by high quality institutional
The financings have extended Immutep s cash runway to the end of calendar year 2021, beyond several significant data read-outs. The
proceeds are being used to continue the LAG-3 related programs, including the ongoing clinical development of efti and the manufacturing of IMP761.
Immutep also rationalised its share capital by completing a share consolidation in November 2019, pursuant to which every 10 shares has been consolidated into
Immutep operations experienced minimal disruption as a result of the COVID19 pandemic. Protecting the health of patients recruited into the
Company s clinical trials and its employees has been a key priority for Immutep. The Company has been working closely with its clinical sites and regulators to monitor the situation and make any necessary adjustments to trial protocols to
diminish risks to patients. Importantly, the Company has not seen a significant impact on the pace of trial recruitment for its two actively recruiting trials: TACTI-002 and
INSIGHT-004. AIPAC has been fully recruited since June 2019.
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REVIEW OF OPERATIONS AND ACTIVITIES (CONTINUED)
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 March 2020, Immutep reported the first results from AIPAC, including supportive efficacy data. PFS
results showed that efti provided an improvement for patients compared to the placebo group at the 6-month landmark. In addition, efti demonstrated an increased Overall Response Rate (ORR) of 48.3% compared to