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Company Announcements
Australian Stock Exchange,
Announcement of Results Year ended 30 June 2013
Please find attached the Appendix 4E and annual financial report for the year ended 30 June 2013.
General Counsel & Company
PRELIMINARY FINAL REPORT
| Name of entity: | Prima BioMed Ltd | |
| ABN: | 90 009 237 889 | |
| Reporting period: | Year ended 30 June 2013 | |
| Previous corresponding period: | Year ended 30 June 2012 |
| Revenue from ordinary activities | Down | 4.7% | to | $4,005,394 | ||||
| Loss from ordinary activities after tax attributable to the owners of Prima BioMed Ltd | Down | 23.6% | to | $(15,225,671) | ||||
| Loss for the period attributable to the owners of Prima BioMed Ltd | Down | 23.6% | to | $(15,225,671) | ||||
| Dividends There were no dividends paid or declared during the current financial period | ||||||||
| Comments The loss of the consolidated entity after providing for income tax and non-controlling interest amounted to $15,225,671 (30 June 2012: $19,940,960) |
| Net tangible asset backing per ordinary security | Reporting period | Previous corresponding period | ||||||
| 2.54 cents | 3.46 cents |
There were no dividends paid or declared during the current financial period
Previous corresponding period
There were no dividends paid or declared during the previous financial period.
report is based on financial statements which have been audited.
Details of attachments (if any):
The annual report for the year ended 30 June 2013 is attached.
| Date: Friday, 30 th August 2013 | ||||||
| Company Secretary |
| Corporate Directory | 03 | |||
| Chairman s Letter | 04 | |||
| Review of Operations | 05 | |||
| Directors Report | 10 | |||
| Management Directory | 15 | |||
| Corporate Governance Report | 26 | |||
| Auditors Independence Declaration | 31 | |||
| Consolidated Statement of Comprehensive Income | 33 | |||
| Consolidated Balance Sheet | 34 | |||
| Consolidated Statement of Changes in Equity | 35 | |||
| Consolidated Statement of Cash Flows | 36 | |||
| Notes to the Consolidated Financial Statements | 37 | |||
| Directors Declaration | 73 | |||
| Independent Auditor s Report to the Members | 74 | |||
| Shareholder Information. | 76 |
| Directors | 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) | ||
| Company Secretary | Ms Deanne Miller | |
| Registered office & | Level 7 | |
| principal place of business | 151 Macquarie Street | |
| Sydney NSW 2000 | ||
| Share Registry | Boardroom Pty Ltd | |
| Level 7, 207 Kent Street | ||
| Sydney, NSW 2000 | ||
| Auditor | PricewaterhouseCoopers | |
| 201 Sussex Street | ||
| Sydney, NSW 2000 | ||
| Solicitors | McCabes | |
| Level 14, 130 Elizabeth Street | ||
| Sydney, NSW 2000 | ||
| Minter Ellison Lawyers | ||
| Level 17, 88 Phillip Street | ||
| Sydney NSW 2000 | ||
| Cooley LLP | ||
| 101 California 5 th Floor | ||
| San Francisco, CA, USA | ||
| 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 |
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.
The cancer 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.
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.
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.
REVIEW OF OPERATIONS
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.
More than 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.
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.
The 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
REVIEW OF OPERATIONS CONTINUED
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
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.
2/3 study ( CANVAS )
At the same time, we have continued our rollout of the phase 2/3 CANcer
VAccine Study or CANVAS trial (protocol CAN-004). As of June 30, 2013, we have achieved the following:
The CANVAS trial is a multi-center, randomized, and placebo-controlled study of CVac in late-stage, mucin 1 positive, epithelial ovarian cancer patients
who have undergone optimal surgery and achieve complete remission after first-line chemotherapy. We plan to recruit approximately 1000 patients at over 100 hospitals throughout Australia, the USA, Europe, and Asia to have 800 evaluable study
patients go through the dosing stage of the trial. The study objectives are to ascertain if CVac, as compared to a placebo, is able to improve the time patients remain in remission before tumor progression (progression-free survival) and extend the
overall survival of patients. Safety parameters, quality of life impact, manufacturing quality, and additional laboratory assessments will also be investigated.
CANVAS has been designed for a robust analysis of the clinical and statistical significance of CVac treatment such that, dependent on positive data
outcomes, CANVAS may lead to registration of CVac in one or more geographies, or otherwise make significant strides toward maximizing the commercial value of the CVac franchise to the Company.
The CANVAS study represents a major investment by Prima in the future of the CVac program for ovarian cancer. The Company is highly attentive to the
quality of the execution of this trial and the integrity of the resulting data. As such Prima has spent significant time in preparation for this trial, including major training programs for the cell collection centers around the world, screening of
hundreds of potential hospitals to participate in the program, and a robust quality management system. To date, Prima has received generally positive feedback from doctors, patients, and ethics committees on the design of the CANVAS study. However,
the Company may moderate the speed of the rollout of the trial to assure the highest quality training and cell collection procedures are in place and to assure a smooth scale up in the manufacturing of CVac. We also plan to review the CAN-003 data
carefully to assess the need to make any adaptations to the CANVAS trial.
REVIEW OF OPERATIONS CONTINUED
Exploratory CVac trials in triple-negative breast, colorectal, and pancreatic cancers
In addition to ovarian cancer, and based on early data that demonstrate the safety and immunological activity of CVac, Prima believes there are multiple
potential applications for CVac to stimulate the immune system to target and kill mucin 1 overexpressing cells identified in a variety of cancers
As announced, Prima will conduct three separate phase 2 clinical trials to evaluate the potential of CVac for the treatment of triple-negative breast
cancer (protocol CAN-101), metastatic colorectal cancer (protocol CAN-201), and resectable pancreatic cancer (protocol CAN-301).
were chosen for exploration because there is reliable data on mucin 1 overexpression in these cancer types, patients generally have a median survival period long enough that would allow potential clinical benefit from CVac, the patient populations