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ABN 90 009 237 889 Appendix 4D Interim Financial Report For the Half-Year Ended 31 December 2015 (previous corresponding period: half-year ended 31 December 2014) To be read in conjunction with the 30 June 2015 Annual Re

Key Takeaway: For the Half-Year Ended corresponding period: half-year ended 31 December 2014) To be read in conjunction with the 30 June 2015 Annual Report. In compliance with Listing Rule 4.2A ASX/Media Release (ASX: PRR) Interim Financial Report Results for Announcement to the Market

Full Press Release Details

For the Half-Year Ended
corresponding period: half-year ended 31 December 2014)
To be read in conjunction with the 30 June 2015 Annual Report.
In compliance with Listing Rule 4.2A
ASX/Media Release (ASX: PRR)
Interim Financial Report
Results for Announcement to the Market
Current Reporting Period Half-year Ended 31 December 2015
Previous Reporting Period Half-year Ended 31 December 2014
Revenues Unchanged to
Loss after tax attributable to members Up 775.19 % to ($ 56,021,865 )
Net loss for the period attributable to members Up 775.19 % to ($ 56,021,865 )
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 2015 0.91
As at 31 December 2014 (0.08 )
Explanation of the above information:
The loss after tax attributable to members after removing the effect of the non-cash Share Based Payment to a strategic investor (Ridgeback Capital
Investments), is $8,553,794 for the current reporting period, which is a 33.63% increase from the previous reporting period. The Company received financing from Ridgeback which has been accounted for as a share-based payment, as Ridgeback is a
strategic investor with extensive expertise in the field of cancer immunotherapies (refer Note 9). A non-cash share-based payment of $47,468,071 has been expensed during the current reporting period representing the fair value of the convertible
note and warrants at the time of the EGM approval of the investment from Ridgeback.
For other details of the current year results, refer to the
Directors Report - Review of Operations.
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 23
Independent Auditor s Review Report to the Members 24
Your directors are pleased to provide the following
half-year report on Prima BioMed Ltd and its subsidiaries (referred to hereafter as the Group or Prima or the Company) for the half-year ended 31 December 2015.
The following persons were directors of Prima
during the whole of the half-year and up to the date of this report unless otherwise stated:
Ms Lucy Turnbull, AO (Non-Executive Chairman)
Mr Marc Voigt (Executive Director & Chief Executive Officer)
Mr Albert Wong (Non-Executive Deputy Chairman)
Dr Russell Howard (Non-Executive Director)
Mr Pete Meyers (Non-Executive Director)
Principal Activities
Prima BioMed is a globally active
biotechnology company positioned to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market
for patients and to maximise value to shareholders. Prima s current lead product is IMP321, based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321, which is a soluble LAG-3Ig
fusion protein, is an antigen presenting cell (APC) activator boosting T cell responses for cancer chemo-immunotherapy and in other combinations which has completed early Phase II trials. A number of additional LAG-3 products including antibodies
for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners. Prima BioMed is listed on the Australian Stock Exchange and on the NASDAQ in the US.
Review of Operations
Key highlights and significant
events of the reporting period included:
immunotherapy agent currently in mid-stage clinical development with Prima BioMed, where it is the Company s lead compound. Immunotherapy is a process whereby a disease such as cancer is treated either by activating or suppressing components of
the immune system to generate a response. LAG-3, or Lymphocyte Activation Gene 3, is able to stimulate and in other cases inhibit an immune response, via involvement in a number of immune pathways. IMP321 is a soluble LAG-3Ig fusion protein which
works by binding to MHC class II molecules on APCs such as dendritic cells to activate them. The APCs are important for presenting cancer antigens to T cells and activating them to destroy cancer cells. IMP321 is a first-in-class APC activator.
Directors Report (continued)
A Phase IIb study, known as AIPAC (Active Immunotherapy PAClitaxel) has been initiated in Europe. AIPAC is a
multi-national, randomised, double-blind, placebo-controlled Phase IIb study of IMP321 in metastatic breast cancer in which we aim to enroll 211 patients. This trial has now commenced in Europe with sites in Belgium and the Netherlands having been
initiated. The AIPAC trial will take approximately 3 years to complete, randomising patients 1:1, after the single-arm, safety run in phase, to either standard-of-care paclitaxel plus placebo or paclitaxel plus IMP321. Patients will be dosed for six
months as per the Phase I dosing regimen, after which the responding or stable patients will be maintained for another year with monthly IMP321 injections. The study has been powered to demonstrate a progression free survival (PFS) advantage for the
treatment group. Throughout the study, an independent data monitoring committee will review patient safety, survival rates and demographics at regular intervals.
An Australian pilot Phase I trial called TACTI-mel (Two ACTive Immunotherapeutics in melanoma) was initiated in H1 calendar year 2016. Australia has one of
the highest per capita incidence of melanoma in the world. TACTI-mel will recruit 24 patients with Stage III/IV metastatic melanoma being treated with an approved PD-1 checkpoint inhibitor and adds IMP321 to the dosing regimen. Patients will receive
ascending subcutaneous doses of IMP321 up to 30mg per injection fortnightly for 13 injections. The study will mainly evaluate the safety, pharmacokinetics, pharmacodynamics and anti-tumour activity of IMP321 at the various doses as well as the
nature of the immune response in the combination. The primary endpoint of the study will be safety. This first-in-man study will combine IMP321 as an immune activator, together with a PD-1 checkpoint inhibitor. Other combination trials in progress
at the moment are predominantly focusing on the combination of 2 inhibitors that work to remove the brakes on the immune system. Prima is at the forefront of a potential new frontier in combining checkpoint therapies with different modes of action
( releasing the brake and pushing the gas ) and we have filed a patent in 2015 to support this new application of IMP321.
Calendar year 2015 has been
exciting for both Prima and our partners in terms of the clinical development of our LAG-3 products. A single digit million dollar financial milestone payment was received from GlaxoSmithKline after commencement of their Phase I trials with
GSK2831781 (derived from IMP731) in January 2015. By all accounts this trial seems to be progressing well and at an investor presentation day in November 2015, GSK announced its intention to progress these trials into phase II in 2016; an exciting
validation of the promise of this treatment modality. In August 2015, we announced Novartis had treated their first patient with LAG-525, their humanised version of Immutep s IMP701 antibody for the treatment of cancer, triggering an
undisclosed, modest milestone payment.
Our collaboration with Yamaguchi University and NEC Corporation is also progressing well. The signing of a second
material transfer agreement or MTA was concluded at the end of calendar year 2015, under which we will provide clinical grade IMP321 to Yamaguchi University for a fee. They will test IMP321 as an APC activator in a cancer vaccine trial, together
with their proprietary cancer peptides, in an investigator led clinical research study. The Yamaguchi/Prima collaboration was conceived based on evidence that IMP321 at low doses can be used as a T cell adjuvant for cancer vaccines because of
IMP321 s ability to activate dendritic cells.
Prima is well positioned as an industry leader in the LAG-3 space. We own the original patents
protecting the LAG-3 gene and antibodies; we have the founder and leading expert of LAG-3, Dr Fr d ric Triebel; we have multiple products with different modes of action in development with multiple partners; we have completed 10
clinical trials to date and are starting two new clinical trials; and we have continuous research and development ongoing to identify new technologies in this exciting space. Upcoming data from large pharmaceutical companies in the LAG-3 space will
add value to technologies targeting the LAG-3 checkpoint.
Directors Report (continued)
Prima BioMed announced on 14 May 2015 that Ridgeback Capital Investments, a US-based specialist healthcare investor, would be investing $15m in Prima.
Ridgeback took an immediate placement of approximately 72 million Prima shares at 1.73 cents per share, worth $1.25m, and committed to investing the remainder of its $15m commitment via 3% convertible notes which convert, at Ridgeback s
election, into Prima ordinary shares at 2.00 cents per share. Shareholders approved this investment after the reporting period at an Extraordinary General Meeting on 31 July 2015, resulting in Prima receiving approximately $14m. Concurrent with
the Ridgeback investment Prima BioMed announced a Share Purchase Plan at 5 cents per share in July 2015 that raised an additional $10m.
the convertible note and warrants as at the date of shareholder approval at the EGM was $61.2m. An amount of $47.5m has been recognised in the statement of comprehensive income as a share-based payment, reflecting both the increase in the value of
the convertible note and the fair value of the warrants issued.
In addition, Prima BioMed placed approximately $3.55m with two institutional investors
during the half-year. The capital raising from Ridgeback, the Share Purchase Plan and funds from the two institutional investors resulted in an increase in cash and term deposits to $25.5m in the first half of financial year 2016.
The Company has benefited from cash grants of $420k from the Australian R&D tax incentive program and grants from the Saxony Development Bank in Germany.
The reduction in the grants received during the period compared to last year is commensurate with the reduction in the R&D expenditure in Australia during the same period last year. The Saxony Development Bank grant expired in December 2014;
however, the last funds were received in October 2015.
Our R&D expenditure arises from contracts with Contract Research Organisations (CROs),
Contract Manufacturing Organisations (CMOs) and clinical investigators. As a result of ceasing the recruitment and consolidation of the CVac clinical development programs, Prima was able to significantly reduce R&D expenditure whilst further
developing R&D in relation to assets acquired in the Immutep acquisition.
Performance Rights were granted as Long Term Incentives ( LTIs )
and Short Term Incentives ( STIs ) used under the Executive Incentive Plan as follows:
In addition 42,000,000 Performance Rights were granted under the Executive Incentive Plan including 20 million for the CEO based on shareholder approval
at the Extraordinary General Meeting held on 31 July 2015.
On vesting of either LTIs or STIs, shares will be issued for no consideration. The
expense recorded for the first half amounted to $1.26m.
Our total corporate and administrative expenditure increased in the first half of 2015 to $4.2m
also as a result of the share-based payments recognised under the Executive Incentive Plan.
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: 29th Day of February 2016
Auditor s Independence Declaration
As lead auditor for the review of Prima BioMed Ltd for the half-year ended 31 December 2015, I declare that to the best of my knowledge and belief, there have
is in respect of Prima BioMed Ltd and the entities it controlled during the period.
Rod Dring Sydney
Partner 29 February 2016
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Last updated: Mar 1, 2016