Full Press Release Details
03 Corporate Directory
04 Chairman s Letter
06 Review of Operations
21 Management Directory
40 Corporate Governance
49 Auditor s Independence Declaration
52 Consolidated Statement of Comprehensive Income
53 Consolidated Balance Sheet
Statement of Changes in Equity
55 Consolidated Statement of Cash Flows
56 Notes to the Consolidated Financial Statements 104 Directors Declaration
105 Independent Auditor s Report to the Members of Prima BioMed Ltd
107 Shareholder Information 2
Directors Ms Lucy Turnbull, AO (Non Executive Chairman)
Mr Marc Voigt (Executive Director & Chief Executive Officer from 9 July 2014) Mr Albert Wong (Non
Executive Deputy Chairman) Mr Martin Rogers (Non Executive Director until 15 November 2013) Dr Richard Hammel (Non Executive Director until 12 February 2014) Dr Russell Howard (Non Executive Director) Mr Pete Meyers
(Non Executive Director appointed on 12 February 2014) Mr Matthew Lehman (Executive Director & Chief Executive Officer until 9 July 2014)
Company Secretary Ms Deanne Miller
office & principal Level 7 place of business 151 Macquarie Street
Share Registry Boardroom Pty Ltd Level 7, 207 Kent Street Sydney, NSW 2000
Auditor PricewaterhouseCoopers 201 Sussex Street Sydney, NSW 2000
Solicitors Minter Ellison Lawyers Level 17, 88 Phillip Street Sydney NSW 2000
Level 31, 1 O Connell Street Sydney NSW 2000 Australia
Banker National Australia Bank Ltd Kew Branch Melbourne, Victoria 3000
Stock exchange listings Prima BioMed Ltd shares are listed on the:
Australian Securities Exchange (ASX code: PRR), NASDAQ (NASDAQ code: PBMD), and Deutsche B rse (ISIN code: US74154B2034)
Website address www.primabiomed.com.au
On behalf of the board of Prima
BioMed, I am pleased to present the annual report for 2014. It has been a year of progress, with important achievements in our CVac development program, but we have also faced our share of challenges.
A key event in the past year was the announcement of the top-line data of our CAN-003 clinical study of patients in first
and second remission ovarian cancer. The impact of the data was significant, leading to a refocusing of our organisation and clinical trial program from first line remission ovarian cancer patients to second line remission patients.
As presented at the American Society of Clinical Oncology (ASCO) conference in May 2014, CVac demonstrated a clinically
significant improvement in median PFS as compared to standard of care for epithelial ovarian cancer patients in Lucy Turnbull, AO remission after second-line treatment, as well as a very encouraging trend in overall survival for patients in second
During the past year, we have consolidated our operational activities (our clinical trial
program and our CVac manufacturing) in Germany. This makes it possible to gain the best possible advantage from the funding grants provided by the Free State of Saxony and to generate cost savings and enhance operational efficiencies. This
consolidation has generated considerable savings in the research and development costs associated with our CAN-004 clinical study, which is now focused on second remission ovarian cancer patients. We have also been preparing for the commencement of
a pilot trial in resected pancreatic cancer and we are excited to explore CVac s potential in this cancer indication.
In the past year, the field of cancer immunotherapy continued to attract considerable interest in the scientific and medical community and we have strengthened our regulatory position by
receiving Fast Track designation from the FDA in the US. In addition we recently received a US patent grant for CVac.
In February, Prima and Neopharm entered into a licensing agreement for CVac in Israel, Prima s first commercial partnership.
Cash expenditure continues to be prudently managed and controlled. Prima BioMed has a solid cash balance of $23.2 million
as at the end of June 2014.
In February 2014, Pete Meyers, currently CFO at TetraLogic Pharmaceuticals
Corporation and formerly Co-Head of Global Healthcare Investment Banking at Deutsche Bank Securities Inc., joined the board of directors. He replaced Rick Hammel, who was a director of Prima for eight years. We thank Rick for his service as a
director. Our Clinical Advisory Board has also been significantly strengthened with the appointments of Professors Pujade-Lauraine, Marth, Monk and Vergote during the year, leaders in the field of oncology.
After the end of the financial year, Marc Voigt was appointed as CEO. Marc has held the position of CFO and Chief Business
Officer since 2012. Having also held the position of General Manager of the Company s European
CHAIRMAN S LETTER CONTINUED
Operations for the past two and a half years, and with his strong commercial background, the Board has every confidence in Marc s ability to steer Prima BioMed through its next phase
towards commercial development. We gratefully acknowledge the past achievements of departing CEO Matt Lehman, who has helped us, design a robust clinical development and manufacturing program for CVac.
Finally, I would like to express appreciation to all shareholders for their ongoing support. We hope like the Prima board
of directors and management team, you believe that you are making a valuable contribution to the fight against two of the toughest cancers there are ovarian and pancreatic cancer through new cancer immunotherapies.
Lucy Turnbull, AO Chairman Prima BioMed Ltd
Operating and Financial Review
On behalf of the directors and management team of Prima BioMed, I am pleased to report on our operations in the past
The fiscal year 2014 was one of the important milestones as well as significant changes and
challenges. These milestones included clinical data analysis, refinement of a robust clinical trial design, regulatory milestones, patent grants and the consolidation of our operations into Europe.
We finished the financial year 2014 in sound financial shape with approximately A$23.2 million in cash and term deposits
to fund our continued investment in research and development. Other than the usual trade liabilities we have no debt. As in the past years we have also benefited from non-dilutive cash resources from the Australian R&D tax incentive program and
two separate grants from the Saxony Development Bank in Germany.
During FY 14 we raised $6,845,000 in the
share purchase plan shortfall placement in July and August 2013.
Financial Performance
Total other income for FY14 was $3,140,066 which was comparably less than the approximately $4 million in total other
income received in the previous financial year. This decrease was essentially due to lower foreign exchange gains and less interest income being earned during FY14 ($406,628 in FY14 vs. $1,417,613 in FY13). Encouragingly, we received significantly
more grant income ($2,004,198 in FY14 compared to $1,648,725 in FY13).
Total corporate administrative expenses
and research and development costs were significantly less this year compared to FY13.
administrative expense for FY14 was $4,092,623 ($4,851,195 in FY13). Most of this decrease was due to a significantly reduction in our administrative expenses ($2,496,308 in FY13 to $1,900,409 in FY14). Our ability to successfully reduce our
corporate administration expenses reflects our cost conscious behavior and efforts to continually strive to minimize expenses.
The vast majority of the R&D expenses were driven by our CVac clinical trial program. Our most significant expenses for FY14 were our contracts with the Contract Research Organisations
(CRO) and Contract Manufacturing Organisations (CMO) who we engage for our CVac clinical trial program. Due to our revised clinical trial program for CVac and consolidation of manufacturing into Germany we were able to lower our R&D expenses by
$2,026,809 compared to the same period last year. This reduction was achieved as we renegotiated and terminated certain CRO and CMO contracts. Our R&D costs are expected to increase over the next financial year as enrolment onto our CVac
clinical trial program increases and we open further clinical sites.
OPERATIONS CONTINUED
CVac clinical development
One of the major tasks during the 2014 financial year was the refinement of our clinical trial program based on the data
of our CAN-003 study. Prima s clinical development of CVac is now strongly focused on the treatment of platinum-sensitive epithelial ovarian cancer patients who have no evidence of disease after second-line chemotherapy. This area represents a
significant medical need due to the high relapse rates and high morbidity associated with the disease. In 2014, Prima obtained Fast Track status for this program from the U.S. FDA which complements the previously granted Orphan
Drug designation for epithelial ovarian cancer in both the United States and Europe. These designations confer advantages to the Company such as expedited regulatory reviews, reduced regulatory fees, and market exclusivity after product
The Company estimates a potential market for CVac in this indication alone of up to 25,000 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
The Company s development strategy in ovarian cancer has been refined by the analysis of the CAN-003 trial data. Top-line data from the 63 patient randomized phase 2 trial was
presented at the European Cancer Congress (ECCO) in October 2013. Final progression-free survival data and interim overall survival data were presented at the American Society of Clinical Oncology annual meeting (ASCO) in May 2014. First Remission
Hazard ratio 1.18(95% CI:0.51. 2.71) P=0.69 by log-rank test (2-sided)
Second Remission HRO.32
OSC; median PFS 18.20 months
Hazard ratio 0.32 (95% Cl: 0.10, 1.03) P0.04
by log-rank test (2-sided)
OSC. median PFS 4.94 months
CVAC: median PFS not reached (>12.91 months)
OSC 4/17 3/11 0/8 3/8 0/0 OSC 6/10 2/4
CVAC 4/19 5/14 2/9 2/6 0/3 CVAC 2/10 2/6 0/4
(ievgnts/#at risk) (#Qvents/#a( risk)
OPERATIONS CONTINUED
The CAN-003 trial included patients who were in remission after standard first or
second-line chemotherapy. The primary endpoint of this trial was Progression-free Survival (PFS), defined as the time from randomization in the trial until the time of disease progression (recurrence of the cancer). CVac did not appear to have a
measurable effect on PFS in the first remission patients. However, the data indicated that CVac conferred a clinically meaningful improvement in PFS for those patients in second remission. There were 20 patients in second remission of which 10 were
given CVac and 10 were standard of care. The median PFS time for the control group patients was 4.94 months, which is consistent with other published studies of ovarian cancer. The median PFS time for CVac patients was not reached, but is more than