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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 2024 Previous corresponding period

Key Takeaway: Immutep Limited released its preliminary final report for the year ended June 30, 2024, indicating an increase in overall losses to AUD 42.7 million, though other income rose to AUD 7.8 million. The report highlights significant progress in clinical trials for efti, particularly in oncology, emphasizing partnerships and positive clinical data. Despite the revenue increase, the lack of dividends and the financial losses raise concerns about the company's short-term stability. The report also notes the challenging market conditions for biotech companies in the early months of 2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • Increased other income by over 5 million, reaching 7,838,625 AUD.
  • Progress in advancing efti through clinical trials for multiple cancer indications.
  • Strong safety profile of efti allows pairing with various therapies.

CONCERNS & RISKS

  • Loss from ordinary activities after tax increased to (42,716,625) AUD.
  • No dividends were paid or declared during the current financial period.
  • Biotech indices underperformed during the first half of CY2024, indicating operational challenges.

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 2024
Previous corresponding period: Year ended 30 June 2023
FY2023 FY2024
Revenue from ordinary activities No change to
Other income Up 5,200,128 to 7,838,625
Loss from ordinary activities after tax attributable to the owners of Immutep Limited Up (39,896,348) to (42,716,625)
Loss for the period attributable to the owners of Immutep Limited Up (39,896,348) to (42,716,625)
Dividends There were no dividends paid or declared during the current financial period.
Explanation of the above information:
The increase in loss after tax for the financial year ended 30 June 2024 was mainly attributable to 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
12.5 cents 10.7 cents
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 2024 is attached.
Date: Friday, 30 August 2024
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 32
CORPORATE GOVERNANCE STATEMENT 33
ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORT 33
FINANCIAL STATEMENTS 34
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME 35
CONSOLIDATED BALANCE SHEET 36
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY 37
CONSOLIDATED STATEMENT OF CASH FLOWS 38
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS 39
CONSOLIDATED ENTITY DISCLOSURE STATEMENT (CEDS) 82
DIRECTORS DECLARATION 83
INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF IMMUTEP LIMITED 84
SHAREHOLDER INFORMATION 89
Directors
Dr Russell Howard (Non-Executive Chairman)
Mr Pete Meyers (Non-Executive Director & Deputy Chairman)
Mr Marc Voigt (Executive Director & Chief Executive Officer)
Prof. Fr d ric Triebel (Executive Director & Chief Scientific Officer)
Ms Lis Boyce (Non-Executive Director)
Ms Anne Anderson (Non-Executive Director, appointed on 14
February 2024)
Company Secretaries Ms Deanne Miller
Ms Indira Naidu
Registered office & Level 32
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 Shareholders,
On behalf of the Board, I m
pleased to present Immutep Limited s Annual Report for the 2024 Financial Year.
Immutep continues to be the leading biotech focused on the
development of products using Lymphocyte Activation Gene-3 (LAG-3) for the treatment of cancer and autoimmune disease. LAG-3
immunotherapy is an exciting and promising area drawing increasing attention from global pharmaceutical companies.
It has been a remarkable year for
Immutep with further impressive clinical results and good progress delivering on our strategy to advance our lead product candidate, eftilagimod alfa (efti) through clinical trials towards market approvals. We have continued later-stage clinical
evaluation of efti in three large oncology indications, namely first line non-small cell lung cancer, first line head and neck squamous cell carcinoma, and metastatic breast cancer. We have also initiated
earlier stage trials in soft tissue sarcoma and urothelial cancer.
Within the fast-emerging area of cancer therapy, efti is the only LAG-3 product that activates antigen-presenting cells (e.g. dendritic cells) and, in turn, activates both the adaptive and innate immune systems to drive a broad immune response that fights cancer. Another key
advantage is efti s strong safety profile which enables it to be paired with a variety of other cancer therapies, including anti-PD-(L)1 therapies, radiotherapy,
Immutep s strategy to develop efti as part of a combination therapy opens up multiple strategic opportunities. Our options include
partnering with an existing efti collaboration partner, partnering/collaboration with the owner of any of the other cancer therapies, or drug commercialisation opportunities for ourselves. Aligned with these options, Immutep continues to build value
and options for our commercial path by continuing to advance efti towards marketing authorisation while retaining all commercial rights at this time.
June 2024, we entered into our third and most important collaboration with MSD for our upcoming registrational Phase III trial in non-small cell lung cancer (1L NSCLC) called
TACTI-004. In addition to working together, MSD is also supplying KEYTRUDA for the trial. TACTI-004 is among the few global Phase III trials evaluating a
combination therapy with KEYTRUDA that addresses almost the entire 1L NSCLC patient population eligible for anti-PD-(L)1 therapy. This is significant as KEYTRUDA became
the world s top-selling drug in 2023, and lung cancer was estimated to represent over 35% of KEYTRUDA s $25 billion in sales last year. With positive feedback now received from multiple agencies
and other stakeholders, we are planning to enrol the first patient into this ~750 patient trial in late 2024 or early 2025.
Thanks to the tireless
efforts of Immutep s team and management we made excellent progress on the clinical front during the financial year and continued to report strong clinical data including:
Beyond these conference presentations, we reported positive results from efti in combination with MSD s KEYTRUDA from the TACTI-003 Phase IIb trial in first line head and neck squamous cell carcinoma (1L HNSCC). In the randomised Cohort A portion of the trial, we are excited to see patient response rates in 1L HNSCC from the
combination exceed KEYTRUDA monotherapy across all levels of PD-L1 expression (an indicator of whether or not a patient is likely to respond to KEYTRUDA therapy on its own).
Furthermore, we are pleased to see the high response rates and complete responses in Cohort B from the combination therapy in patients with no PD-L1 expression (CPS <1%) and its prominent selection of these results for oral presentation at an ESMO Virtual Plenary session in July 2024.
CHAIRMAN S LETTER (CONTINUED)
Additionally, encouraging initial safety and efficacy data in soft tissue sarcoma (STS), including deep
responses rarely seen with standard therapeutic approaches, was reported in May 2024 from the EFTISARC-NEO Phase II trial evaluating the novel triple combination of efti with radiotherapy and KEYTRUDA. STS is a
hard-to-treat orphan disease with poor prognosis and high unmet medical need.
Importantly, during the financial year Immutep successfully scaled up its manufacturing process for efti to commercial levels (2,000L) and received regulatory
authorisation to use the product in its clinical trials across multiple countries.
Underpinning Immutep s position as a pioneer in the advancement
of LAG-3 immunotherapy, we continue our preclinical efforts with our longstanding collaborators at Cardiff University to development an orally available, small molecule blocking anti-LAG-3 therapy to treat cancer. An easy-to-administer oral pill may offer significant cost
advantages over anti-LAG-3 antibodies that are under development or have received regulatory approval.
Moving to autoimmune diseases, we appointed the Centre for Human Drug Research, a world-class institute in Leiden, the Netherlands, to perform the first-in-human clinical study of IMP761, Immutep s proprietary LAG-3 agonist antibody. IMP761 aims to restore balance to
the immune system by enhancing the brake function of LAG-3 to silence unregulated self-antigen-specific memory T cells that accumulate at disease sites. By addressing the underlying cause of many
autoimmune diseases, this first-in-class agonist LAG-3 immunotherapy potentially opens up multiple large therapeutic markets for
Immutep including rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.
Shifting to financials, the overall biotech equity market reached a
trough during the fourth quarter of CY2023 and then started to recover as the multi-year global challenges in healthcare began to abate. Nonetheless, during the first half of CY2024 the biotech indices have underperformed the broader markets and
challenges remain in place for many biotech companies. Despite this, strong support from new and existing shareholders enabled Immutep to raise $100.2 million (~US$63 million) via a fully underwritten issue of new equity during the financial
year. The new funds provide us with a very strong cash position and extends our cash runway to the end of calendar year 2026.
Although we are in a
fundamentally strong position, as we continue to advance efti towards registration, we are disappointed that our significant progress to date has not yet been adequately reflected in the share price.
To strengthen our Board, Immutep appointed Anne Anderson as independent non-executive director in February 2024. Ms
Anderson has extensive board governance and leadership experience serving Australian and international companies, including more than 35 years in her executive career focused on the finance and investment sectors.
As we look ahead, we are very excited about the coming year with many important milestones in our sights. Our confidence in efti and its potential to make
meaningful positive change in the treatment landscape for cancer patients is as strong as ever.
On behalf of the Board, I would like to thank all of our
shareholders for their continued support of Immutep. We look forward to keeping you updated on our continued progress in the year ahead.
Chairman, Immutep Limited
REVIEW OF OPERATIONS AND ACTIVITIES
PRINCIPAL ACTIVITIES
Immutep is a late-stage clinical
biotechnology company developing novel LAG-3 related immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte
Activation Gene-3 (LAG-3). It has a diversified product portfolio that harnesses LAG-3 s unique ability to stimulate the
body s immune response to fight cancer or suppress it to address autoimmune disease.
Immutep is dedicated to leveraging its expertise to bring
innovative treatment options to patients in need and to maximise value for shareholders. The Company is listed on the Australian Securities Exchange (IMM) and on the NASDAQ (IMMP) in the United States.
REVIEW OF OPERATIONS
Eftilagimod Alfa Through Late-Stage Development
Immutep is advancing its lead product candidate, eftilagimod alfa (efti) through late-stage
clinical trials towards marketing approval in three cancer indications:
TACTI-004: Phase III trial in first line non-small
cell lung cancer (1L NSCLC)
TACTI-004 (also designated KEYNOTE-PNC-91) is Immutep s pivotal Phase III trial of efti in combination with MSD s anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy in 1L NSCLC, one of the most significant cancer indications with a high unmet medical need. The trial is designed to set a new standard of care and is considered
to be the key value driver of Immutep.
In June 2024, Immutep entered into its third and most important clinical trial collaboration and supply agreement
with MSD (Merck & Co., Inc., Rahway, NJ, USA), for the TACTI-004 Phase III trial. Under the collaboration, Immutep will conduct the trial and retain commercial rights to efti, while MSD will supply
KEYTRUDA at no cost to Immutep.
TACTI-004 will be a 1:1 randomised, double-blind, multinational, controlled
clinical study to evaluate Immutep s efti in combination with KEYTRUDA and standard chemotherapy compared to the standard-of-care combination of KEYTRUDA,
chemotherapy and placebo in first-line metastatic NSCLC, regardless of PD-L1 expression. In this pivotal PD-L1 all comer trial, the dual primary endpoints will be
progression-free and overall survival with a prespecified futility boundary and a pre-planned interim analysis.
During FY24, Immutep advanced preparations for the trial, including productive interactions with regulatory agencies and other stakeholders. In December 2023,
Immutep received supportive and constructive feedback from the German regulatory authority, the Paul-Ehrlich-Institut, which was followed by similar feedback in April 2024 from the Spanish Agency for Medicines and Health Products (AEMPS) Competent
Authority. Subsequent to the end of the financial year, a final discussion with the US Food and Drug Administration (FDA) took place, successfully concluding the strategic regulatory preparations for the trial design.
In other trials targeting 1L NSCLC, efti in combination with KEYTRUDA without chemotherapy (TACTI-002) or with
chemotherapy (INSIGHT-003) has generated compelling efficacy and favourable safety across all levels of PD-L1 expression, including negative (TPS <1%) and low (TPS 1-49%) PD-L1.
TACTI-004 will enrol
approximately 750 patients regardless of PD-L1 expression and include both squamous and non-squamous subtypes to address almost the entire 1L NSCLC market eligible for anti-PD-1 therapy. The first patient is expected to be enrolled in late CY2024 or Q1 CY2025.
REVIEW OF OPERATIONS AND ACTIVITIES (CONTINUED)
TACTI-003: Phase IIb trial in first line head and neck squamous

Frequently Asked Questions

What was Immutep Limited's revenue for FY2024?

Immutep Limited reported no change in revenue from ordinary activities for FY2024.

What was the loss after tax for FY2024?

The loss from ordinary activities after tax increased to $42,716,625 for FY2024.

Were dividends paid during the financial period?

No dividends were paid or declared during the financial period ending June 2024.

What is Immutep's main product for cancer treatment?

Immutep's lead product is eftilagimod alfa, targeting cancer and autoimmune diseases.

Who partnered with Immutep for the TACTI-004 trial?

Immutep collaborated with MSD for the TACTI-004 trial using KEYTRUDA.

Last updated: Sep 3, 2024