Full Press Release Details
Interim Financial Report
(previous corresponding period: half-year ended 31 December 2016)
To be read in conjunction with the 30 June 2017 Annual Report.
In compliance with Listing Rule 4.2A
ASX/Media Release (ASX: IMM)
Appendix 4D Interim Financial Report
Results for Announcement to the Market
Current Reporting Period Half-year Ended 31 December 2017
Previous Reporting Period Half-year Ended 31 December 2016
| Revenues | Up | 100 | % | to | 2,580,410 | |||||||||||
| Loss after tax attributable to members | Up | 6.5 | % | to | (4,324,912 | ) | ||||||||||
| Net loss for the period attributable to members | Up | 6.5 | % | to | (4,324,912 | ) |
| 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 2017 | 0.35 | |||
| As at 31 December 2016 | 0.57 |
| Directors Report | 2 | |||
| Auditor s Independence Declaration | 6 | |||
| Consolidated Statement of Comprehensive Income | 7 | |||
| Consolidated Balance Sheet | 8 | |||
| Consolidated Statement of Changes in Equity | 9 | |||
| Consolidated Statement of Cash Flows | 10 | |||
| Notes to the Consolidated Financial Statements | 11 | |||
| Directors Declaration | 21 | |||
| Independent Auditor s Review Report to the Members | 22 |
Your directors are pleased to provide the following
half-year report on Immutep Limited and its subsidiaries (referred to hereafter as the Group or Immutep or the Company) for the half-year ended 31 December 2017.
The following persons were directors of
Immutep 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) | |
| Mr Grant Chamberlain | (Non-Executive Director: appointed 21 August 2017) | |
| Ms Lucy Turnbull, AO | (Non-Executive Chairman: prior to 17 November 2017) | |
| Mr Albert Wong | (Non-Executive Deputy Chairman: prior to 17 November 2017) |
Principal Activities
Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutics for the treatment of cancer and autoimmune
diseases. Immutep is dedicated to leveraging scientific vision and clinical acumen to discover and develop novel immunotherapies and to partner with leading organisations to maximise the full therapeutic potential of these cutting-edge technologies.
Immutep s current lead product candidate is eftilagimod alpha ( Efti or IMP321 ), a soluble
LAG-3Ig fusion protein, 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.
Immutep is listed on the Australian Stock Exchange (IMM), and on NASDAQ (IMMP) in the United States.
Review of Operations
The Company has undergone
significant change in the last six months to reflect its status as a globally recognised leader in LAG-3. Immutep shareholders voted to accept the name change from Prima BioMed to Immutep at the Company s
Annual General Meeting on 17 November 2017. Under the Immutep name, the Company intends to build awareness of its portfolio of LAG-3 based immunotherapy assets and attract more investor interest.
Immutep now refers to its lead LAG-3 product candidate as eftilagimod alpha, or Efti for short.
Eftilagimod alpha is the International Non-proprietary Name (INN) for LAG-3Ig or IMP321. The INN designation is regulated by the World Health Organisation.
Additional key highlights and significant events of the reporting period included:
Directors Report (continued)
Clinical Trial Updates
The Company s Australian Phase I clinical trial in metastatic melanoma, TACTI-mel, is progressing well and the
three cohorts are now fully recruited with 18 patients in total. New data was presented in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 2017 Annual Meeting in the United States in November. The findings demonstrated
anti-tumour activity when Efti is administered in combination with pembrolizumab, with tumour reductions observed in 58% of advanced metastatic melanoma patients in the study, which is extremely encouraging for future clinical indications of Efti,
as well as drug combination trials. The first results from all three cohorts are anticipated towards the end of the first half of calendar year 2018. Encouraged by the TACTI-mel Phase I clinical trial interim
results presented at SITC in November 2017, the Company announced earlier this month that it plans to expand the TACTI-mel study by six patients at 30 mg of Efti in combination with pembrolizumab starting at
cycle one and with a treatment duration of 12 months.
Similarly, recruitment for the randomised phase (226 patients) of the Phase IIb AIPAC trial in
metastatic breast cancer is expected to be completed by mid-calendar year 2018. 31 out of 34 clinical sites have been activated with the remainder expected within the next few months. Data in December 2017
confirmed the positive response from the open-label safety run-in cohort of 15 patients as presented at the American Society of Clinical Oncology (ASCO) in June. The data showed that the combination of Efti
plus weekly paclitaxel in patients with metastatic breast cancer is safe and well tolerated; moreover, an overall response rate of 47% was observed. The primary Progression Free Survival data readout of this portion of the study could be available
as early as the first half of calendar year 2019.
The investigator-led INSIGHT clinical trial, in which Efti is
administered as an intra-tumoural or intraperitoneal injection, continues to make positive progress following the receipt of ethical and regulatory approvals in July 2017. Four patients have already been recruited and single case data is expected
throughout calendar year 2018.
In November, Immutep had a Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration to discuss the regulatory pathway for the development of Efti in the United States. The meeting was productive, and Immutep intends to file an IND in the
first half of calendar year 2018. This filing would provide the opportunity to commence clinical studies and regulatory interactions in the United States - a critical component of the Company s global commercialisation strategy for Efti.
The pre-clinical development of early stage product candidate, IMP761, is advancing. IMP761 is the first humanised
antibody which acts as an agonist to one of the three major immune checkpoint molecules in oncology (CTLA-4, PD-1, and LAG-3).
New preclinical data should be published in 2018.
Immutep continues to collaborate with its pharma partners on their respective clinical development programs and in broadening the Company s patent
In November, Immutep announced a new patent from the European Patent Office, which is geared toward the use of Immutep s lead candidate,
Efti, in combination with a chemotherapeutic agent for the treatment of cancer. In September, Immutep announced the grant of a patent in Japan for its IMP731 antibody, which was licensed to GlaxoSmithKline (GSK) in December 2010. Immutep also
announced in September the grant of a Japanese patent for the use of Efti in the treatment of infectious diseases. This suggests the broader potential of Efti as an immunostimulant and provides protection for a range of possible clinical indications
A new research collaboration between Monash University and Immutep was announced in August, in conjunction with a A$360,000 grant by the
Australian Research Council. The research, which will be conducted over a three year period, aims to further understand the way that LAG-3 controls T cell signaling, which is important for both cancer and
Directors Report (continued)
Immutep s Chinese partner, EOC Pharma, an oncology focused affiliate of Eddingpharm that holds the
Chinese rights for Efti, continues to leverage the improved clinical and regulatory environment in China and successfully raised US$32 million in capital from Chinese investors in November 2017. EOC plans to use these funds to commercialise its
oncology portfolio, including Efti. This is part of a broader effort to increase access to novel therapies for patients. Immutep is set to receive milestone payments as EOC Pharma continues its development of Efti in China. In December 2017, EOC
Pharma received the approval of Investigational New Drug (IND) from the FDA in China, this triggered its first milestone payment of US$1 million to Immutep.
In November, Immutep s partner Novartis increased the number of patients in its Phase I / II clinical study with IMP701 to 515, and also started a new
Phase II study with 160 patients.
Furthermore, the Phase I study being conducted by GSK with IMP731 is now fully recruited with an expected completion
Industry Conferences
November, Immutep s Chief Medical Officer and Chief Scientific Officer, Dr. Fr d ric Triebel presented new data from the company s TACTI-mel Phase I clinical trial at the Society
for Immunotherapy of Cancer (SITC) - a key conference in the field of immuno-oncology which took place in the United States.
Dr. Triebel, presented at the World Immunotherapy Congress in Switzerland where he discussed the therapeutic potential of LAG-3 and provided an overview of Immutep s clinical program.
The company also attended several other high profile industry conferences including the BIO-Europe 2017 partnering
conference in Germany and the European Society of Oncology (ESMO) 2017 congress in Spain. It is increasingly evident from these events that checkpoint inhibitors including those that modulate the LAG-3 immune
control mechanism are attracting significant interest from the scientific, medical, pharmaceutical and investment communities. Immutep is well placed to capitalise on this interest.
Immutep s financial position was
strengthened at the start of the 2018 financial year with the U.S. capital raise of approximately US$5 million (approximately A$6.5 million), the Company s first capital raise using American Depository Shares (ADS) since listing on NASDAQ
in 2012. Strategically, it provided important financial headroom to fund existing clinical development programs and brought several U.S. specialist healthcare institutional investors onto the share register.
Since July, a second milestone payment of US$1 million was received from partner Novartis relating to Immutep s IMP701 LAG-3 antibody, also referred to as LAG525. Immutep is eligible to receive further potential development based milestone payments and royalties as the program progresses.
Immutep received its first milestone payment of US$1 million from EOC Pharma on 31 January 2018. However, this US$1 million milestone has been
recognised as revenue in December 2017, i.e. when the FDA in China approved the IND, which was the trigger for the milestone being achieved.
Immutep received a 0.9 million (approximately A$1.3 million) cash rebate from the French Government for the research and development activities conducted in Europe during the calendar year 2016.
At 31 December 2017, the consolidated entity had total funds of $13.7 million comprising cash in hand at bank of $8.3 million and short term
deposits of $5.4 million. Based on our current projections, we estimate that our cash reach extends to at least the end of the first calendar quarter of 2019.
Changes to Board of Directors
17 November 2017, long-serving Chair, Lucy Turnbull and Vice-Chair, Albert Wong resigned as Directors of Immutep at the Company s 2017 AGM. Lucy Turnbull remains a significant shareholder in Immutep. They were succeeded by current
directors, Dr Russell Howard and Pete Meyers as Chair and Vice Chair, respectively.
New Non-Executive Director,
Grant Chamberlain, joined the Board in August 2017.
Directors Report (continued)
Auditor s independence declaration
A copy of the auditor s independence declaration as required under section 307C of the Corporations Act 2001 is set out on page 6. This report is made in
accordance with a resolution of directors.
Dated: 22nd Day of February 2018
Auditor s Independence Declaration
As lead auditor for the review of Immutep Limited for the half-year ended 31 December 2017, I declare that to the best of my knowledge and belief, there
is in respect of Immutep Limited and the entities it controlled during the period.
| Eddie Wilkie | Sydney | |
| Partner | 22 February 2018 | |
| PricewaterhouseCoopers |
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