Full Press Release Details
03 Corporate Directory
04 Chairman s Letter
06 Review of Operations
21 Management Directory
39 Corporate Governance
48 Auditors Independence Declaration
51 Consolidated Statement of Comprehensive Income
52 Consolidated Balance Sheet
Statement of Changes in Equity
54 Consolidated Statement of Cash Flows
55 Notes to the Consolidated Financial Statements
109 Directors Declaration
Auditor s Report to the Members of Prima BioMed Ltd
112 Shareholder Information
Ms Lucy Turnbull, AO (Non Executive Chairman)
Mr Albert Wong (Non Executive Deputy Chairman)
Mr Martin Rogers (Non Executive Director)
Dr Richard Hammel (Non Executive Director)
Dr Russell Howard (Non Executive Director)
Mr Matthew Lehman (Managing Director & Chief Executive Officer)
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I am pleased to report on this past year s progress at Prima BioMed in the development of CVac, the Company s
personalized immunocellular therapeutic for the treatment of cancer.
In the treatment of cancer, personalized
immunocellular therapeutics uses a patient s own blood cells to make a cancer treatment product that is beneficial but far less toxic than most cancer therapies used today. The promise of an immunocellular product like CVac is to provide longer
term control of cancer and ultimately increased survival and a better quality of life for patients.
immunotherapy field has garnered significant interest in the scientific, medical, and financial communities over the past year. Increasing numbers of academic organizations and biopharmaceutical companies are investing in clinical trials for new
products in this field. At Prima we are very excited about being a global leader, developing the technology that underpins personalized immunocellular therapeutics. We believe the increasing industry interest in this field is a positive development
that may benefit Prima as we continue our CVac clinical development programs.
In October and November 2012, we
reported positive interim data from our ongoing phase 2 trial of CVac as maintenance treatment for epithelial, ovarian cancer (the CAN-003 study). We saw encouraging trends of increasing progression-free survival for those patients receiving CVac
versus the control group.
As we complete the initial monitoring period of the CAN-003 trial, the topline
immunological, progression-free survival, and initial overall survival data will be presented on October 1, 2013 by Dr. Jeffrey Goh at the European Cancer Congress in Amsterdam. The CAN-003 data analysis is an important milestone in our
CVac development pathway. This randomized and controlled 63-patient trial will help refine our clinical trial strategy as we continue the CAN-004 protocol the phase 2/3 CANVAS trial.
The Company has also announced plans to study CVac in three additional cancer indications triple-negative breast
cancer, resectable pancreatic cancer, and metastatic colorectal cancer. We believe these exploratory, phase 2 trials may broaden the potential clinical applications for CVac and enhance its commercial value.
CHAIRMAN S LETTER CONTINUED
With the continued support and investment of the shareholders who participated in our Shareholder Purchase Plan and our Option Entitlement Offer, we finished the 2013 financial year with
just over A$30 million in cash and term deposits. These funds are dedicated to funding our ongoing CVac research and development. Besides our shareholders, the Saxony Development Bank in Germany awarded Prima a 3.8 million Euro grant to support
the new exploratory, phase 2 trials mentioned above as well as important manufacturing development projects. Finally, the Company also received approximately A$ 1.4 million from the Australian government in the form of R&D tax incentives.
On behalf of Prima, I would like to thank you, our shareholders for your loyal support. I look forward to
sharing news of the Company s continued progress in the development of CVac.
Lucy Turnbull, AO Chairman Prima BioMed Ltd
Matthew Lehman (CEO)
On behalf of the directors and management team of Prima BioMed, I am delighted to report on our progress. We have achieved a number of important milestones in the past year and we have
continued to build a strong foundation as we move forward in the development of CVac.
financial year 2013 in sound financial shape with just over A$ 30 million in cash and term deposits to fund our continued investments in research and development. We have no debt. We also benefit from non-dilutive cash resources from the
Australian R&D tax incentive program and two separate grants from the Saxony Development Bank in Germany.
In the 2013 financial year, most of our research and development investments were made in two areas: our ongoing clinical
trials for CVac in ovarian cancer and our operational platform to strengthen our position as a global leader in the technology and manufacturing of personalized immunocellular therapeutics. We also invested moderate amounts of cash in start-up
activities related to exploratory trials of CVac that will start in this upcoming financial year.
1000 shareholders invested $ 6,651,262 in Prima by participating in our Shareholder Purchase Plan and our Option Entitlement Offer. We raised a further $ 1,062,988 prior to 30 June 2013 and $ 6,845,000 subsequent to our financial year end from
sophisticated investors who participated in the Share Purchase Plan shortfall placements, resulting in total funds raised from these capital raisings of $ 14,559,250. These funds, in addition to co-funding from the Saxony Development Bank in
Germany, will help us to continue with our clinical and manufacturing development plans.
Financial Performance
During the financial year 2013 we benefited from an R&D tax rebate of $ 1,442,120 and foreign exchange
gains of $ 1,417,613 driven by the impact of changes in our US and Euro cash holdings.
As of the end of the
financial year, Prima had 30 employees in Australia, the United States, and Germany. We also use the services of a number of dedicated consultants and contract companies to support us in key areas of our clinical development programs.
Our most significant expenses are our contracts with Contract Research Organisations (CROs) and Contract Manufacturing
Organisations (CMOs). Our R&D costs were less this year partly due to more favourable terms which we negotiated with our CROs and CMOs and the discontinuance of the Cripto-1 antibody program, as announced on 8 June 2012.
OPERATIONS CONTINUED
Our corporate and administrative expenses were also less this year as compared to the
previous year. This reduction was partly due to the closure of our Dubai operations, the inclusion of NASDAQ listing costs in the prior year for our listing in April 2012, the appointment of our Chief Operating Officer as our Chief Executive Officer
in September 2012 and the merging of our Chief Financial Officer and Chief Business Officer roles into one position in November 2012.
CVac clinical development for the treatment of ovarian cancer patients in remission
Prima s lead program is the development of CVac for the treatment of epithelial ovarian cancer patients who are in complete remission after first-line surgery and chemotherapy. This
area represents a significant medical need due to the high relapse rates and high morbidity associated with the disease. Prima has obtained orphan-drug designation for epithelial ovarian cancer in both the United States and Europe, which confers
advantages to the Company such as reduced regulatory fees and market exclusivity after product approval.
Company estimates a potential market for CVac in this indication at approximately 33,300 new patients per annum in the major markets of the United States, Australia, Japan, United Kingdom, Germany, France, Italy, and Spain, as well as
significant additional opportunities in other global markets.
CAN-003 phase 2 study
In October and November 2012, we reported positive interim data from our ongoing phase 2 trial of CVac as maintenance
treatment of epithelial ovarian cancer (the CAN-003 study). Data suggest that CVac has minimal side effects and none of the toxicity one would expect with more traditional cancer therapies. We saw encouraging trends of increasing progression-free
survival for patients receiving CVac versus the control group. The immune monitoring completed for the first cohort of seven patients tested, we also saw that CVac induces a killer T cell response that is specific to mucin 1, a prominent antigen
target on the surface of many cancer cells.
As of the end of the financial year, we are close to completion of
the progression-free survival monitoring period for patients on the CAN-003 trial. We will continue monitoring these patients through 2014 to assess the longer term overall survival outcomes. As Prima previously announced, the topline immunological,
progression-free survival, and overall survival data from the CAN-003 trial will be presented on October 1, 2013 by Dr. Jeffrey Goh at the European Cancer Congress in Amsterdam.
This 63-patient trial is an important milestone for Prima the CAN-003 trial is the first study we will have
completed in our target patient population of ovarian cancer patients in remission. Although a small trial with patients in the first and second remission, we expect that the CAN-003 data will validate our general clinical development strategy and
will help inform our ongoing clinical trials of CVac.
OPERATIONS CONTINUED