Full Press Release Details
Preliminary final report
| Name of entity: | Immutep Limited | |
| ABN: | 90 009 237 889 | |
| Reporting period: | Year ended 30 June 2022 | |
| Previous corresponding period: | Year ended 30 June 2021 |
| FY 2021 | FY 2022 | |||||||||||||||
| Revenue from ordinary activities | Up | Nil | to | 170,369 | ||||||||||||
| Other income | Up | 3,968,133 | to | 6,587,704 | ||||||||||||
| Loss from ordinary activities after tax attributable to the owners of Immutep Limited | Up | (29,902,624 | ) | to | (32,210,826 | ) | ||||||||||
| Loss for the period attributable to the owners of Immutep Limited | Up | (29,902,624 | ) | to | (32,210,826 | ) | ||||||||||
| 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 $32,210,826 (30 June 2021: loss of $29,902,624). |
Explanation of the above information:
The increase in loss after tax for the financial year ended 30 June 2022 was mainly attributable to the following:
The above increases in loss were offset by an increase in other income from the following:
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 | ||||||
| 9.6 cents | 8.1 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 2022 is attached.
| Date: Wednesday, 31 August 2022 | ||||
| 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 | 10 | |||
| AUDITOR S INDEPENDENCE DECLARATION | 27 | |||
| CORPORATE GOVERNANCE STATEMENT | 28 | |||
| FINANCIAL STATEMENTS | 29 | |||
| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME | 30 | |||
| CONSOLIDATED BALANCE SHEET | 31 | |||
| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | 32 | |||
| CONSOLIDATED STATEMENT OF CASH FLOWS | 33 | |||
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS | 34 | |||
| DIRECTORS DECLARATION | 76 | |||
| INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF IMMUTEP LIMITED | 77 | |||
| SHAREHOLDER INFORMATION | 82 |
| Directors | ||||
| Dr Russell Howard | (Non-Executive Chairman) | |||
| Mr Pete Meyers | (Non-Executive Director & Deputy Chairman) | |||
| Mr Marc Voigt | (Executive Director & Chief Executive Officer) | |||
| Ms Lucy Turnbull, AO | (Non-Executive Director) | |||
| Company Secretaries | Ms Deanne Miller | |||
| Ms Indira Naidu | ||||
| Registered office & | Level 33 | |||
| principal place of business | 264 George Street | |||
| Australia Square | ||||
| 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 2022.
Immutep continued to forge its leadership role in the emerging
LAG-3 landscape throughout a year that saw increasing attention from industry on this exciting new immune checkpoint. As a global biotech developing immunotherapeutic products for cancer and autoimmune
disease, we have more product candidates and programs focused on LAG-3 than any other drug development company and we have retained our status of being the only LAG-3
In March 2022 the first LAG-3 product, a Bristol-Myers Squibb (BMS) combination of LAG-3 inhibitor, relatlimab and PD-1 inhibitor, nivolumab (Opdualag ) received approval from the United States Food
and Drug Administration for the treatment of melanoma in patients. The approval marked the validation of LAG-3 as the next most promising immune checkpoint, following the success of PD-1 and PD-L1 inhibitors, such as pembrolizumab and avelumab, and the CTLA-4 inhibitor, ipilimumab. The emergence of LAG-3 is all the more significant in light of the recent failure of anti-TIGIT clinical trials in H1 2022.
Opdualag hit the market only a number of weeks ago and has already surprised the industry with $58 million in sales in the three months to June 2022, doubling expectations for first
quarter of sales. The combination product is tipped to meet its $4 billion peak sales target across multiple cancer indications.
As a pure-play LAG-3 company, this validation triggered renewed excitement in Immutep s pipeline of four product candidates. Our lead product candidate, called eftilagimod alpha (efti) has a unique mechanism of action in the
growing LAG-3 product landscape. While most LAG-3 products are blocking agents, efti is the only LAG-3 product that activates
antigen-presenting cells to drive an adaptive immune response.
The financial year saw considerable progress from Immutep and efti, which is being
evaluated as part of combination therapies with chemotherapy and PD-1 and PD-L1 inhibitors. Efti was shown to improve overall survival in key subgroups of breast cancer
patients when administered in combination with paclitaxel in the Phase IIb AIPAC study.
Efti is also demonstrating encouraging efficacy through the Phase
II TACTI-002 trial which evaluates efti in combination with pembrolizumab in three different cancer indications. In 1st line non-small cell lung cancer (NSCLC) a
promising 38.6% of patients are responding to the combination therapy. The data are supportive of continued late-stage clinical development of efti in 1st line NSCLC.
In 2nd line NSCLC interim results are showing an encouraging median overall survival of 9.7 months from the combination therapy. Lastly, in 2nd line head and
neck squamous cell carcinoma (HNSCC) there is a response rate of 29.7%, along with favourable duration and depth of responses. Importantly, efti has consistently reported a good safety profile across all its trials to date.
Given the encouraging results we ve reported across these key trials in metastatic breast cancer and NSCLC, Immutep now has optionality to progress the
development of efti in multiple indications. We are carefully reviewing our clinical plans to potentially prioritise one indication as we continue to progress towards commercialization of efti. From the strength of the data already presented, the
unmet patient need and the significant market opportunity, the business may prioritise development in 1st line NSCLC. This would be in addition to our ongoing development program in 1st line HNSCC which has FDA Fast Track designation. Ultimately the
aim would be for Immutep or its partners to obtain marketing authorisation in multiple indications to fully exploit the potential of efti with its unique mechanism of action.
With our late-stage development pipeline growing, the Company has been actively progressing upscaling of its manufacturing for efti to ensure sufficient
volume of the drug is available for a Phase III trial, as well as commercial volumes.
Immutep s positive clinical results were reported during a
year of macroeconomic uncertainty stemming from supply chain disruptions, the ongoing COVID pandemic, geopolitical tensions and inflation. This broader environment has severely impacted the share prices of most companies in the biotech sector
globally, including Immutep s share price.
Fortunately, Immutep s operations have not been significantly impacted by the current macroeconomic
landscape. We had enrolled a small number of patients into the TACTI-003 trial at clinical sites in the Ukraine prior to the outbreak of the war and have been able to successfully continue treating most of
these patients from alternative locations.
Immutep also continued its collaborations with four major pharmaceutical companies: Novartis, GSK,
Merck & Co (MSD) and Merck (Germany) during the year, along with EOC Pharma and LabCorp. The breadth and depth of these partnerships confers strong validation of Immutep s technology, product candidates and R&D competencies.
We undertook a two-tranche placement and a Share Purchase Plan (SPP) at the end of FY 2021 and were delighted to be
supported by multiple new and existing institutional investors from Australia and offshore. The financings raised a total of A$67.2m before transaction costs, with the second tranche and SPP shares being issued following approval by shareholders
within the financial year 2022, 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 also extend our cash runway into early calendar year 2024.
I would like to thank our shareholders for their continued support of the Company throughout the year. We are pleased with the encouraging clinical results
from efti and are equally excited about what lies ahead for Immutep. Our focus is on cultivating the best late-stage development strategy for efti to deliver value to our shareholders.
We look forward to updating you on our progress over the coming twelve months.
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, with currently more product candidates and programs focused on LAG-3 than any other drug development company. The Company 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 has four 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 late-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. In addition, there are also ongoing research activities for
potential new candidates.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
REVIEW OF OPERATIONS
LAG-3 has emerged as the next promising immune checkpoint in immunotherapy for cancer, Immutep s technologies and clinical results have drawn increasing industry attention. This year, the Company has
continued to advance efti through key clinical trials and reported interim and final results throughout the year. Data from its metastatic breast cancer trial (AIPAC) and its metastatic head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) trial (TACTI-002) were selected for presentation at multiple prestigious cancer conferences. All data has been consistently encouraging from
an efficacy perspective and importantly, has also supported efti s good safety profile to date.
This encouraging data from efti in multiple cancer
indications has built its value from a patient, industry and shareholder point of view. Furthermore, Immutep now has optionality to prioritise advancing efti into late-stage clinical trials in breast cancer and NSCLC. This is in addition to
Immutep s later-stage trial in HNSCC that is currently recruiting patients (TACTI-003).
new and existing shareholders, Immutep completed two financings during the financial year related to the completion of a two-tranche placement and share purchase plan (SPP) that was initiated in June
2021. The Company raised in total A$67.2m before transaction costs, of which A$53.4m was completed in July 2021.The second tranche and SPP shares were issued following approval by shareholders at an EGM in July 2021. The placement was supported
by high-quality institutional investors in Australia and offshore.
The funds are 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 into the early calendar year 2024.
Clinical Trials with Eftilagimod Alpha
AIPAC Trials Late-Stage Development in Metastatic Breast Cancer
Immutep s Phase IIb AIPAC trial evaluated efti in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination. The
trial was a randomised, double blinded, placebo-controlled clinical study in 227 HR+/HER2- metastatic breast cancer patients and was conducted across more than 30 clinical 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.
In November 2021, Immutep reported positive final Overall Survival (OS) data from AIPAC at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting 2021. The trial reported very encouraging OS data, including a statistically significant and clinically meaningful benefit in three prespecified subgroups representing most patients. A survival benefit
of +7.5 months was observed in patients < 65 years, reflecting a > 50% improvement compared to the control group. A +19.6 months survival benefit was seen in patients with low monocytes, a benefit of > 150% compared to the control group.
Lastly, a survival benefit of +4.2 months was reported in luminal B patients, reflecting a > 33% benefit compared to the control group.
later reported biomarker and multivariate analysis data and insights from the trial at ESMO s Breast Cancer Congress in May 2022. The analysis showed a statistically significant increase in innate and adaptive immune response biomarkers
(monocyte and CD8+ T cell counts and serum CXCL10 levels) and absolute lymphocyte count (ALC) was observed in the efti group, but not in the placebo group. These improved immune parameters correlated with improved OS of the patients, confirming efti
is activating the immune system and helping patients live longer. In addition, an observed early rise in ALC in patients treated with efti may provide clinicians with a potential predictor of improved survival, helping them to determine early on if
continued treatment with efti is beneficial. The exploratory analysis also identified six patient subgroups that showed improvements in OS. These subgroups are relevant for patient population selection for future late-stage studies in breast cancer.
The positive results from AIPAC are supportive of further development of efti in metastatic breast cancer. However, given the encouraging results Immutep
is also seeing from efti in 1st line NSCLC from TACTI-002 (see below), the Company is reviewing its clinical plans for metastatic breast cancer and NSCLC to potentially prioritise one indication.
In the meantime, Immutep is continuing its regulatory interactions for the development program for efti in metastatic breast cancer. This includes dialogue
with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), following feedback from the EMA regarding the efti program received in October 2021 and the FDA in March 2022.