Full Press Release Details
Company Announcements
Australian Stock Exchange, Sydney
Announcement of Results Year ended 30 June 2014
Please find attached the Appendix 4E and annual financial report for the year
General Counsel & Company Secretary
Preliminary final report
PRELIMINARY FINAL REPORT
| Name of entity: | Prima BioMed Ltd | |
| ABN: | 90 009 237 889 | |
| Reporting period: | Year ended 30 June 2014 | |
| Previous corresponding period: | Year ended 30 June 2013 |
| Revenue from ordinary activities | Down | 21.6% | to | $3,140,066 | ||||
| Loss from ordinary activities after tax attributable to the owners of Prima BioMed Ltd | Down | 12.36% | to | $(13,343,381) | ||||
| Loss for the period attributable to the owners of Prima BioMed Ltd | Down | 12.36% | to | $(13,343,381) | ||||
| 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 $13,343,381 (30 June 2013: $15,225,671) |
| Net tangible asset backing per ordinary security | Reporting period | Previous corresponding period | ||||||
| 1.83 cents | 2.54 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 2014 is attached.
| Date: Wednesday, 27 th August 2014 | ||||||
| Company Secretary |
| Corporate Directory | 03 | |||
| Chairman s Letter | 04 | |||
| Review of Operations | 06 | |||
| Directors Report | 10 | |||
| Management Directory | 16 | |||
| Corporate Governance Report | 28 | |||
| Auditor s Independence Declaration | 34 | |||
| Consolidated Statement of Comprehensive Income | 36 | |||
| Consolidated Balance Sheet | 37 | |||
| Consolidated Statement of Changes in Equity | 38 | |||
| Consolidated Statement of Cash Flows | 39 | |||
| Notes to the Consolidated Financial Statements | 40 | |||
| Directors Declaration | 74 | |||
| Independent Auditor s Report to the Members | 75 | |||
| Shareholder Information | 77 |
| 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 | |
| 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 | Minter Ellison Lawyers | |
| Level 17, 88 Phillip Street | ||
| Sydney NSW 2000 | ||
| K&L Gates | ||
| 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 remission after second-line treatment, as well as a very encouraging trend in overall
survival for patients in second line remission.
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 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 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.
CHAIRMAN S LETTER CONTINUED
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
REVIEW OF OPERATIONS
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 financial year.
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
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.
Total corporate administrative expense for FY14 was $4,092,623 ($4,851,195 in FY13). Most of this decrease was due to a significant 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.
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 approval.
REVIEWED OF OPERATIONS CONTINUED
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.
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 date 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 12.91 months. This is very
The interim data on overall survival (OS), defined as the time from randomization in the trial until the data of death from any cause,
was also presented at ASCO. Prima expects the OS data to be mature enough for analysis by approximately the end of calendar year 2014. Interim trends indicate that, similarly to the PFS data, CVac is having a strong effect on OS in the second
remission patient population.
Other CAN-003 endpoints suggest that CVac has minimal side effects and none of the toxicity one would expect with
more traditional cancer therapies, such as chemotherapy. The immune monitoring completed during the trial indicates that CVac induces a killer T cell response that is specific to mucin 1, a prominent antigen target on the surface of many cancer
Completion of the CAN-003 trial is an important milestone for Prima, as this was the first randomized study performed for CVac. The
magnitude of the increase in PFS, as well as the extended duration of the PFS intervals, in conjunction with the early OS data in the second remission patient group are very compelling signals. The strong signals observed validate our continued
development strategy for CVac in this indication.
REVIEWED OF OPERATIONS CONTINUED
In April, the first patient was screened into the 210-patient randomized phase 2 trial of CVac versus standard of care in platinum-sensitive epithelial
ovarian cancer patients who have no evidence of disease after second-line chemotherapy.
CAN-004 (or CANVAS ) was originally designed as
a randomized, 800-patient, phase 2/3 trial of CVac as compared to placebo for the treatment of ovarian cancer patients in first remission with a primary endpoint of PFS. Based on the CAN-003 trial data reported in late 2013, Prima suspended
enrolment of new patients onto this trial and amended the CAN-004 protocol. Using the existing network built up for the previous program, Prima will enroll 210 ovarian cancer patients in second remission a similar population that has
thus far responded well in the CAN-003 protocol. The 210-patient cohort is intended to confirm the trends observed in the CAN-003 trial in a larger patient population. The primary endpoint of the study is OS, with important secondary endpoints
including PFS, time to next line treatment, quality of life, and immune monitoring. Convincing CAN-004 data would open multiple regulatory options for Prima and could put Prima in a good position to negotiate potential pharma partnerships.