Full Press Release Details
Preliminary final report
PRELIMINARY FINAL REPORT
| Name of entity: | Prima BioMed Ltd | |||
| ABN: | 90 009 237 889 | |||
| Reporting period: | Year ended 30 June 2017 | |||
| Previous corresponding period: | Year ended 30 June 2016 |
| Revenue from ordinary activities | Down | 100 | % | to | ||||||||||||
| Other income | Up | 128 | % | to | $ | 4,221,534 | ||||||||||
| Loss from ordinary activities after tax attributable to the owners of Prima BioMed Ltd | Down | 85 | % | to | $ | (9,367,206 | ) | |||||||||
| Loss for the period attributable to the owners of Prima BioMed Ltd | Down | 85 | % | to | $ | (9,367,206 | ) | |||||||||
| 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 amounted to $9,367,206 (30 June 2016: $62,015,184) |
For other details of the current year results, refer to the Directors Report Review of Operations.
| Net tangible asset backing per ordinary security | Reporting period | Previous corresponding period | ||
| 0.36 cents | 0.72 cents |
Preliminary final report
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.
This report is based on financial statements which have been audited.
Details of attachments (if any):
The annual report for the year ended 30 June 2017 is attached.
| Date: Monday, 28 th August 2017 | ||||
| Company Secretary |
| CORPORATE DIRECTORY | 1 | |||
| CHAIRMAN S LETTER | 2 | |||
| REVIEW OF OPERATIONS | 3 | |||
| DIRECTORS REPORT | 6 | |||
| AUDITOR S INDEPENDENCE DECLARATION | 24 | |||
| FINANCIAL STATEMENTS | 25 | |||
| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME | 26 | |||
| CONSOLIDATED BALANCE SHEET | 27 | |||
| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | 28 | |||
| CONSOLIDATED STATEMENT OF CASH FLOWS | 29 | |||
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS | 30 | |||
| DIRECTORS DECLARATION | 70 | |||
| INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF PRIMA BIOMED LTD | 71 | |||
| SHAREHOLDER INFORMATION | 78 |
| Directors | 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) | |||
| Mr Grant Chamberlain | (Non Executive Director) | |||
| Company Secretary | Ms Deanne Miller | |||
| Registered office & principal place of business | Level 12 | |||
| 95 Pitt Street | ||||
| Sydney NSW 2000 | ||||
| Share Registry | Boardroom Pty Ltd | |||
| Grosvenor Place | ||||
| Level 12, 225 George Street | ||||
| Sydney, NSW 2000 | ||||
| Auditor | PricewaterhouseCoopers | |||
| One International Towers Sydney, Watermans Quay | ||||
| Barangaroo, NSW 2000 | ||||
| Solicitors | 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), and | ||||
| NASDAQ (NASDAQ code: PBMD) | ||||
| Website address | www.primabiomed.com.au |
Dear Fellow Shareholder,
On behalf of the Prima BioMed Board, I
am pleased to present the Annual Report for 2016/2017.
The last twelve months have been marked with positive results from both of Prima s active
clinical trials and our U.S. financing which has positioned Prima in solid financial stead through the fourth-quarter of 2018.
Regarding our recent share
price performance, your Board and management team are acutely aware of this and share in the frustrations felt by shareholders given the recent flow of positive Company news. While the market s reaction is beyond Prima s control, we are
dedicated to advancing our multiple immunotherapy assets in clinical development and driving global awareness of LAG-3 technologies. This recognition was reflected recently with our second milestone payment from partner Novartis.
Fundamentally, Prima is in a sound position as the global leader in the LAG-3 field. As our clinical trials progress,
we firmly believe these data will demonstrate the therapeutic benefit of IMP321 in cancer treatment and thus drive shareholder value.
IIb chemo-immunotherapy clinical trial in breast cancer is currently recruiting for the randomisation phase across several European centres. Data from the initial safety run-in stage was presented at the 53rd American Society of Clinical Oncology
(ASCO) conference and demonstrated that IMP321 is safe and well tolerated, and generated a positive immune response.
TACTI-mel, our Australian melanoma
clinical trial with IMP321 in combination with Keytruda commenced recruitment of the third cohort. Data from the first two cohorts will be announced before the end of calendar 2017 and from
all three cohorts in the first half of calendar 2018.
Twelve months ago we announced a collaboration with the Institute of Clinical Cancer Research
in Frankfurt. Having received the necessary ethical and regulatory approvals, the investigator-led trial, called INSIGHT , will be the first ever investigation into whether direct injection of IMP321 into a solid
tumour can activate the antigen presenting cells inside tumours to boost the body s immune response. It s very evident that our lead product, IMP321, is gaining traction on the global stage as an innovative product with many potential
therapeutic applications.
The U.S. financing has enhanced our profile among professional U.S. healthcare investors and reinforces our position as a
leader in the development of immunotherapy assets on the global stage. We also benefitted from significant R&D tax grants in France and Australia and anticipate future milestone payments from our pharmaceutical partners, which include Novartis,
GlaxoSmithKline, and Eddingpharm.
We welcomed Grant Chamberlain to the Board as a Non-Executive Director last
week. Mr Chamberlain brings extensive corporate finance and capital markets experience to Prima s Board. His Australian and international markets experience will be a valuable asset as we progress our clinical development programs and
consolidate our global leadership in LAG-3.
I would like to thank shareholders for their continued support and
patience. We acknowledge that our share price performance has not reflected our good progress, but our focus remains firmly on delivering our program of highly prospective assets and enhancing shareholder value.
I look forward to updating you on our further progress in the year ahead.
REVIEW OF OPERATIONS
On behalf of the directors and management of Prima BioMed, I am pleased to report on our operations for the past financial year.
Operational and Financial Review
Fiscal year 2017 was a
very active time for Prima, with encouraging data released for both clinical trials testing IMP321 in metastatic breast cancer and melanoma, along with additional patent grants, new collaborations, and a new product candidate.
Undoubtedly one of the highlights was the release of data from the safety run-in phase of our AIPAC (Active Immunotherapy PAClitaxel) Phase IIb clinical trial
at the 53rd Annual American Society of Clinical Oncology (ASCO) conference in Chicago in June, the most prestigious global oncology conference attended by more than 30,000 delegates. The cohort of 15 patients receiving IMP321 in combination with
paclitaxel demonstrated IMP321 to be safe and well-tolerated and we also reported positive immune responses.
Data from the first patient cohort of
TACTI-mel (Two ACTive Immunotherapeutics in melanoma), the Company s Australian Phase I melanoma trial testing IMP321 in combination with Keytruda , was presented in March at the Immune
Checkpoint Inhibitors Conference in Boston.
Financially, we ended the year on a high note, securing US$5 million (A$6.5 million) from specialist
U.S. healthcare funds through the issuance of new American Depository Shares (ADSs), our first capital raise using our ADSs since we listed on the NASDAQ in 2012. This is significant both in terms of extending our cash reach to continue funding our
clinical development of IMP321, but also in bringing additional sophisticated U.S. investors on to our share register.
In July, we announced the receipt
of our second milestone payment of US$1 million (A$1.3 million) from Novartis relating to Prima s IMP701 LAG-3 antibody. Additional potential milestones could be expected from Novartis and our other development partners, GSK and
Eddingpharm within the coming years.
Financial Performance
Other income increased by A$2.3m to A$4.2m for FY2017 from A$1.9m for FY2016. The increase was primarily attributable to A$1.9m higher cash tax rebates from
the Australian and French governments recognised in the fiscal year of 2017.
In April Prima received a A$492,144 cash rebate from the Australian Federal
Government s R&D tax incentive program, which was provided in respect of expenditure incurred on eligible research and development activities conducted in FY2016 and mainly related to our TACTI-mel
trial being conducted in Australia. The company has also benefited from cash grants of 618,307 (approximately A$867,000) from the French Cr dit d Imp t Recherche scheme (received in February 2017) for the eligible R&D
expenditures incurred in the calendar year 2015 in Europe. In addition, Prima has recognised approximately A$0.6m grant income from the Australian Federal Government s R&D tax incentive program and A$1.3m (received in August 2017) from
French Cr dit d Imp t Recherche scheme for the expenditure incurred on eligible research and development activities conducted in the fiscal year of 2017 and the calendar year of 2016, respectively.
Miscellaneous income increased by A$98k to A$0.8m for FY2017 from A$0.7m for FY2016. This increase was primarily attributable to sales growth of manufactured
product used in research.
Interest income for FY2017 was A$104k versus A$264k for FY2016. The decrease was due to a decrease in the level of cash held on
term deposits and a reduction in interest rates.
Corporate administrative expenses for FY2017 was A$4.3m compared to A$7.0m in FY2016. This decrease of
A$2.7m was primarily due to a decrease of A$1.2m in finance, legal and consulting expenses, a decrease of A$0.4m in labour expenses, and a decrease of A$1.2m in employee share-based payment expenses in FY2017 compared to the prior period.
Research and development and intellectual property expenses increased by A$466k to A$7.5m for FY2017 from A$7.1m for FY2016. The slight increase was expected
and was primarily due to the increase in R&D expenses due to patient recruitment for our two IMP321 related clinical trials, AIPAC and TACTI-mel, and the development of our new product candidate IMP761.
REVIEW OF OPERATIONS (CONTINUED)
Depreciation and amortization expenses decreased to A$1.7m for FY2017 from A$2.0m for FY2016. This was due to
certain intellectual property assets and the plant & equipment of CVac being written off during the fiscal year of 2016.
Net loss decreased to
A$9.4m for the fiscal year of 2017 from A$62.0m for the fiscal year of 2016. This decrease was primarily due to the accounting treatment for a share based payment to a strategic investor where A$47.5 million was expensed in FY2016. The amount
represents the difference between the accounting fair value of convertible notes and warrants issued to Ridgeback Capital Investments and the cash received, which was expensed on grant date.
Finance costs were nil for FY2017 compared to A$8.2k for FY2016. The interest expense incurred in the fiscal year of 2016 related to other borrowings which
were repaid in August 2015.
Changes in fair value of the comparability milestone were nil for FY2017 compared to A$0.5 million for FY2016. This
amount related to a payment into a retention account on the acquisition of Immutep which was measured at fair value through the profit and loss.
change in fair value of the convertible note liability was A$0.8m for FY2017 compared to A$0.6m for FY2016. The increase was attributable to the liability component of the convertible note being measured at fair value.
Meanwhile, we continue to tightly manage costs across the business to maximise our cash reach. Coupled with our recent US capital raise, R&D tax refunds
and cash inflows from our collaboration agreements we have solidified Prima s financial position with projected cash reach now well into the fourth quarter of calendar 2018.This extended cash reach does not include additional potential
milestone payments from existing partnerships, which, if received, would extend our cash reach even further.
Strategic Development
Our focus for FY2017 was on our LAG-3 programs, specifically progression of our lead product candidate IMP321. AIPAC is
progressing well with patient recruitment for the randomised part of the study having commenced in January. Poland and Hungary have now come on stream in addition to centres in Belgium and the Netherlands and the United Kingdom. To date, 19 clinical
sites have been activated with the study expected to be fully recruited in H1 calendar 2018. Final data from the safety run-in cohort is expected before the end of this calendar year.
TACTI-mel commenced recruitment of the third cohort at the 30mg dose level following the successful completion of the first two cohorts confirming the
drug s safety profile at the 1mg and 6mg dose levels. Data from the first two cohorts will be announced before the end of the calendar year, with data from all three cohorts expected to be announced in the first half of calendar 2018.
Securing the future supply of IMP321 is a key component of our commercial development strategy, which underpinned our decision to partner with China s
WuXi Biologics as the exclusive global manufacturer for IMP321. We will foster this important partnership that we see extending beyond the manufacturing of IMP321 to involve new products in Prima s pipeline.
Prima is harnessing even more of the therapeutic potential of the LAG-3 target and expanding our product suite with the addition of a humanised IgG4