Full Press Release Details
Half-Year Financial Report
(previous corresponding period: half-year ended 31 December 2021)
To be read in conjunction with the 30 June 2022 Annual Report.
In compliance with Listing Rule 4.2A.
ASX/Media Release (ASX: IMM)
Appendix 4D Half-Year Financial Report
Results for Announcement to the Market
Current Reporting Period Half-year Ended 31 December 2022
Previous Reporting Period Half-year Ended 31 December 2021
| Revenues | to | |||||||||||||||
| Other Income | down | 9.4 | % | to | 2,582,728 | |||||||||||
| Total revenue and other income | down | 9.4 | % | to | 2,582,728 | |||||||||||
| Loss after tax attributable to members | up | 26.8 | % | to | (20,623,250 | ) | ||||||||||
| Net loss for the period attributable to members | up | 26.8 | % | to | (20,623,250 | ) |
The loss after tax for the half-year ended 31 December 2022 of A$20,623,250 was higher compared to A$16,270,213 for the
half-year ended 31 December 2021. The increase in loss after tax for the period ended 31 December 2022 was mainly attributable to the following:
The above increases in loss were offset slightly by the following:
| Dividends (Distribution) | Amount per Security | Franked Amount per Security | ||
| Final dividend | n/a | n/a | ||
| Previous corresponding period | n/a | n/a | ||
| Record date for determining entitlements to the dividend (in the case of a trust, distribution) | n/a | |||
| Net Tangible Assets per Share (cents)* | ||||
| As at 31 December 2022 | 7.58 | |||
| As at 31 December 2021 | 11.37 |
| Directors Report | 3 | |||
| Auditor s Independence Declaration | 10 | |||
| Half-Year Financial Report | ||||
| Consolidated Statement of Comprehensive Income | 11 | |||
| Consolidated Balance Sheet | 12 | |||
| Consolidated Statement of Changes in Equity | 13 | |||
| Consolidated Statement of Cash Flows | 14 | |||
| Notes to the Consolidated Financial Statements | 15 | |||
| Directors Declaration | 28 | |||
| Independent Auditor s Review Report to the Members | 29 |
This half-year financial report does not include all the notes of the type normally included in an annual financial report.
Accordingly, this report should be read in conjunction with the annual report for the year ended 30 June 2022 and any public announcements made by Immutep Limited during the half-year reporting period in accordance with the continuous
disclosure requirements of the Corporations Act 2001.
Immutep Limited is a company limited by shares, incorporated and domiciled in Australia. Its
registered office and principal place of business is at Level 33, 264 George Street, Australia Square, SYDNEY, NSW 2000. Its shares are listed on the Australian Securities Exchange (ASX) and NASDAQ Global Market (NASDAQ).
Your directors present their report on the group
consisting of Immutep Limited and the entities it controlled at the end of, or during (referred to hereafter as the Group or Immutep and or the Company ) the half-year ended 31 December 2022.
The following persons were directors of
Immutep during the whole of the half-year and up to the date of this report unless otherwise stated:
| 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 | (Non-Executive Director) | |
| Dr Frederic Triebel | (Executive Director & Chief Scientific Officer & Chief Medical Officer: appointed as an Executive Director on 13 September 2022) |
PRINCIPAL ACTIVITIES
Immutep is a globally active biotechnology company and a leader in the development of LAG-3 related immunotherapeutic
products for the treatment of cancer and autoimmune disease. It is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients.
Immutep has more product candidates and programs focused on LAG-3 immune control mechanism than any other drug
development company. Its four product candidates in development have different mechanisms of action. Immutep s lead product candidate is eftilagimod alpha ( efti or IMP321 ), a soluble
LAG-3 fusion protein (LAG-3Ig). It is a first-in-class antigen presenting cell (APC)
activator being explored in late-stage cancer trials. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune diseases. The Company also has two further
LAG-3 products, including antibodies for immune response modulation, being developed by Immutep s large pharmaceutical partners, and is conducting 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 AND ACTIVITIES
year and prior, Immutep has continued to progress its active trials of efti, building on the consistently compelling data reported across three key cancer indications and supporting the broad therapeutic potential of efti for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and metastatic breast cancer (MBC). Immutep has received US FDA Fast Track designation for two of these indications, 1st line NSCLC
and 1st line HNSCC, enabling e.g. expedited review of potential regulatory submissions.
This promising data, coupled with the large market opportunity
and high unmet need for more durable and tolerable options for patients, has informed Immutep s late-stage clinical development strategy for efti which was announced during the period. The Company has determined to focus its late-stage
development efforts on 1st line NSCLC in combination with anti-PD-1 therapy. The NSCLC program (see planned late-stage trial in 1st line NSCLC) will be shaped by the
maturing data from the Company s TACTI-002 and INSIGHT-003 trials, along with feedback from regulatory authorities and other stakeholders.
Immutep will also continue to advance its late-stage programs in HNSCC (see TACTI-003 trial) and MBC (see Late-Stage
Phase II/III Trial in MBC). It is also actively expanding efti into additional indications and combination therapies, with a new trial in soft tissue sarcoma and a new trial in urothelial cancer announced during the half year. This clinical
development strategy strongly positions Immutep, or a potential partner, to fully exploit efti s broad potential.
Immutep was pleased to appoint its
Chief Scientific Officer and Chief Medical Officer, Professor Fr d ric Triebel, M.D. Ph.D. as Executive Director on its Board in the half year, recognising his role as driving force in the strategic development of Immutep s LAG-3 product candidates. Professor Triebel pioneered the recently validated LAG-3 field of immuno-oncology, having discovered the
LAG-3 gene in his early career.
Directors Report (Continued)
Immutep continues to exercise prudent cash management and remains well-funded with a cash balance of
$68.38 million as at 31 December 2022. This provides a cash runway to the end of June, 2024.
Clinical Trials with Eftilagimod Alpha -
Three Late-Stage Trials in Key Cancer Indications
Planned late-stage trial with Fast Track designation in 1st line NSCLC
Aligned with its strategy to advance the clinical development of efti in three key
indications, Immutep progressed preparatory work for its planned late-stage registrational trial evaluating efti in combination with anti-PD-1 for the treatment of 1st line NSCLC. The trial is being designed to obtain sufficient data to support a potential application for regulatory approval for efti in this indication.
A key achievement in this strategy was the grant of Fast Track designation for this combination therapy for treatment of 1st line NSCLC by the United States Food and Drug Administration (US FDA) in October 2022. Fast Track designation offers the Company the potential for expedited development and review by the FDA. The
designation was granted based on the encouraging Phase II clinical data in 1L NSCLC from the TACTI-002 all-comer trial (see page
TACTI-002 section). It is the second Fast Track designation issued by the FDA for efti (the first is for 1st line HNSCC, see
TACTI-003 section). In addition, the INSIGHT-003 study combining efti with anti-PD-1 and
chemotherapy will help further inform our next steps in 1st line NSCLC.
Late-stage trial with Fast Track designation in 1st line HNSCC
TACTI-003 - Phase IIb
TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled trial evaluating efti in combination with
pembrolizumab for the treatment of 1st line HNSCC. It was granted Fast Track designation for 1st line HNSCC by the US FDA in 2021.
from the first 47 patients in the study was reviewed by the trial s Independent Data Monitoring Committee (IDMC) in October 2022, with the IDMC recommending the trial continue with no modifications. The IDMC also reviewed initial efficacy data,
although this was not the primary focus of the analysis. The recommendation validates Immutep s strategy to evaluate efti in the 1st line HNSCC setting, following an encouraging Overall Response Rate (ORR) of 29.7% regardless of PD-L1 expression (a predictive biomarker for effective treatment by immune checkpoint inhibitors such as pembrolizumab) and five complete responses (CR) reported in the 2nd line HNSCC setting in TACTI-002.
A Trial in Progress poster on TACTI-003 was presented at the
Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 in early November in Boston, US.
Recruitment into the trial is ongoing, with more than 50%
of the planned 154 patients enrolled in December 2022 across 25 active trial sites. TACTI-003 is expected to be fully recruited by mid-2023.
Planned Late-Stage Phase II/III Trial in Metastatic Breast Cancer
For the evaluation of efti in MBC, Immutep continued engagement with regulatory authorities throughout the half year, including with the US FDA for its planned
late-stage trial. In December 2022, Immutep received a positive outcome from its follow-up Type C meeting with the FDA. The Company and the FDA have agreed to an integrated Phase II/III trial design to help
inform a potential Biologics License Application (a request for permission to sell a biologic product in the US).
Based on the encouraging efficacy,
favourable safety and learnings from Immutep s completed Phase IIb trial (AIPAC, which administered efti in conjunction with a standard-of-care chemotherapy on
different days and ceased chemotherapy at six months), patients in the new MBC trial will receive efti and paclitaxel chemotherapy on the same day and treatment will continue until disease progression. In addition to HER2 /HR+ metastatic breast
cancer, the patient population has also been expanded to include triple-negative breast cancer, an aggressive form of breast cancer with limited treatment options.
Directors Report (Continued)
Subject to regulatory and ethics committee feedback, the Phase II portion of the trial is expected to begin
in 1st quarter of calendar year 2023 with a safety lead in of 6 to 12 patients, followed by up to 58 patients for the randomised Phase II portion of the trial, testing also a higher dose of efti
(30 mg vs 90 mg). Depending on the Phase II results, regulatory interactions and Immutep s resources, the Phase III portion will commence.
TACTI-002 (also designated KEYNOTE-798) - Phase II
TACTI-002 is Immutep s Phase II trial being conducted in collaboration with Merck & Co. ( MSD ). This all-comer trial in terms of PD-L1 status is evaluating the combination of efti with MSD s KEYTRUDA (pembrolizumab) in NSCLC in 1st and 2nd line, and in HNSCC in 2nd line (Parts A,
B and C, respectively). The trial is fully recruited (189 patients).
Part A 1st line NSCLC Immutep reported compelling new clinical
data from 114 1st line NSCLC patients via a prestigious late-breaking abstract oral presentation at the SITC Annual Meeting in November 2022. Immutep s abstract was selected as one of just nine to be showcased at the SITC 2022 press briefing,
out of more than 1,500 abstract submissions.
The results showed an ORR of 40.4% in the all-comer PD-L1 trial, meeting the primary endpoint for Part A (1st line NSCLC) of the TACTI-002 trial. The ORR improved across all PD-L1 status
groups by central assessment compared with data reported at an earlier cancer conference, ASCO 2022. Additionally, the interim median Duration of Response (DoR) of 21.6 months compares favourably to historical controls.
Promising results were also reported in Part A s secondary endpoint of interim median Progression Free Survival (PFS). Efti in combination with
pembrolizumab has received Fast Track designation after achieving an overall PFS of 6.6 months along with 9.3 months in patients with a PD-L1 Tumour Proportion Score (TPS) >1%.
Part B 2nd line PD-X Refractory NSCLC In August 2022, Immutep reported positive interim data from
patients with 2nd line PD-X-refractory NSCLC at the 2022 World Conference on Lung Cancer (WCLC 2022) in Austria. The median Overall Survival (OS) reported was 9.7 months
in the all-comer PD-L1 patient population, and mOS was not yet reached in patients with PD-L1 TPS of >50%. 25% of patients
were progression free at the key 6-month mark and 36.5% were alive at 18 months. Importantly, the combination treatment continues to be safe and well-tolerated. It also compares favourably to standard of care
chemotherapy-based options. In total 36 patients have been recruited.
Part C 2nd line HNSCC Encouraging antitumor activity was reported in
previous reporting periods, including an ORR of 29.7% and favourable duration and depth of responses, with five Complete Responses and a minimum duration of response extended to more than 9 months across all responding patients. The responses were
reported in both high and low PD-L1 expressors. In total 39 patients have been recruited.