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Prima BioMed Ltd Preliminary final report APPENDIX 4E PRELIMINARY FINAL REPORT 1. Company details Name of entity: Prima BioMed Ltd ABN: 90 009 237 889 Reporting period: Year ended 30 June 2016 Previous corresponding peri

Key Takeaway: Preliminary final report PRELIMINARY FINAL REPORT Name of entity: Prima BioMed Ltd ABN: 90 009 237 889 Reporting period: Year ended 30 June 2016 Previous corresponding period: Year ended 30 June 2015 Revenue from ordinary activities Up 100 % to $ 175,052 Other income

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Preliminary final report
PRELIMINARY FINAL REPORT
Name of entity: Prima BioMed Ltd
ABN: 90 009 237 889
Reporting period: Year ended 30 June 2016
Previous corresponding period: Year ended 30 June 2015
Revenue from ordinary activities Up 100 % to $ 175,052
Other income Down 11.4 % to $ 1,853,869
Loss from ordinary activities after tax attributable to the owners of Prima BioMed Ltd Up 92.9 % to $ (62,015,184 )
Loss for the period attributable to the owners of Prima BioMed Ltd Up 92.9 % to $ (62,015,184 )
There were no dividends paid or declared during the current financial period
the consolidated entity after providing for income tax and non-controlling interest amounted to $62,015,184 (30 June 2015: $32,151,696)
the above information:
The loss after tax for FY16 was A$62,015,184 compared to A$32,151,696 in FY15. The increase was attributable to non-cash
financing costs, including a share-based payment to a strategic investor (Ridgeback Capital Investments) and non-cash changes in the fair value of the financial liability. Removing the impact of those two non-cash items results in a loss after tax
for FY16 of A$13,939,476. This loss is 0.91% higher when compared to the adjusted previous period loss of A$13,813,681 after removing non-cash financing costs of A$18,338,015.
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
0.70 cents 0.12 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 2016 is attached.
Date: Wednesday, 31 th August 2016
Company Secretary
CORPORATE DIRECTORY 1
CHAIRMAN S LETTER 2
REVIEW OF OPERATIONS 3
DIRECTORS REPORT 6
AUDITOR S INDEPENDENCE DECLARATION 21
FINANCIAL STATEMENTS 23
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME 24
CONSOLIDATED BALANCE SHEET 25
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY 26
CONSOLIDATED STATEMENT OF CASH FLOWS 27
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS 28
DIRECTORS DECLARATION 68
INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF PRIMA BIOMED LTD 69
SHAREHOLDER INFORMATION 71
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)
Company Secretary Ms Deanne Miller
Registered office & Level 12
principal place of business 95 Pitt Street
Sydney NSW 2000
Share Registry Boardroom Pty Ltd
Grosvenor Place
Level 12, 225 George Street
Sydney, NSW 2000
Auditor PricewaterhouseCoopers
201 Sussex Street
Sydney, 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 2015/2016. The past 12 months has been a busy time for Prima, the highlight being progression of our lead product IMP321 in two active clinical trials. At the same time our partnerships in other programs
continue to make good progress.
At present, AIPAC, our Phase IIb chemo-immunotherapy study of IMP321-plus-paclitaxel in metastatic breast cancer, is
recruiting well with its second cohort of patients. Just before the end of the financial year we announced initial safety data from the first cohort, which confirmed the safety and tolerability of IMP321, with no drug related serious adverse events.
This significantly de-risks the remainder of the trial. We anticipate that the results of the first safety run in data from both cohorts will be presented in the fourth calendar quarter of 2016.
TACTI-mel, our Australian melanoma trial with IMP321 has six clinical centers approved, with all of them now active. The study will recruit up to 24 patients,
with the interim data of the first cohort (of up to 8 patients) expected before the end of this calendar year.
Financially, the company remains in a good
position following the successful Share Purchase Plan early in the financial year as well as two smaller share placements to sophisticated investors in Europe and Australia. We also continue to benefit from significant R&D tax grants in both
Europe and Australia, where our clinical trials are being conducted, and from milestone payments from our pharmaceutical partners.
management of cash reserves, a rigorous focus on costs and the divestment from our CVac program in February 2015, the Company s cash reach has been extended into the fourth quarter of calendar year 2017. This is a significant improvement on the
outlook provided in last year s Annual Report and our most recent Investor Update.
Partnering CVac to New York-listed SYDYS Corp was considered the
best available solution to secure a viable pathway for CVac s ongoing development and prospects for commercialization. Importantly, this requires no further funding commitment from Prima while providing considerable potential upside should its
commercialisation be achieved, which is dependent on SYDYS Corp raising sufficient capital to continue its development.
pharmaceutical partners, Novartis and GlaxoSmithKline, continue to develop their LAG-3 related products in the clinic. As further clinical development continues, further milestone payments become more likely.
I would like to thank shareholders for their support over the past year and look forward to updating you on further progress in the year ahead in relation to
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 2016 saw
many important and positive events for Prima, most significantly, the initiation of two clinical trials in the LAG-3 field, with early safety data confirmed for our Phase IIb chemo-immunotherapy trial in metastatic breast cancer and progress in our
Our two clinical studies, namely a Phase IIb chemo-immunotherapy trial in metastatic breast cancer (AIPAC) and a Phase I study in
combination with an immune checkpoint inhibitor (TACTI-mel), continue to progress well. Data from the first cohort of patients from AIPAC confirmed the safety and tolerability of our lead compound, IMP321.
In July and August 2015, we completed a successful capital raising which was essential for initiating our two clinical trials for IMP321. The Share Purchase
Plan ( SPP ), which was heavily oversubscribed, was increased from A$5m to A$10m. The decision to terminate our US$37.4m investment facility with Bergen Global Opportunity Fund, by mutual consent, was followed by two smaller placements
with institutional investors. The aggregate amount of these two placements in October and November 2015 was A$3.55m.
Shareholders ratified the issue of
further securities to Ridgeback Capital Investments L.P. at the Extraordinary General Meeting held on 31 July 2015. In accordance with the approval by shareholders, the Company issued ordinary shares, a convertible note and warrants. Assuming
that Ridgeback Capital Investments L.P. exercises all warrants and convertible notes, an additional 1,067,462,626 ordinary shares may be issued in future reporting periods. The total proceeds from the issuance of the above securities amounted to
These capital raising initiatives, coupled with collaboration cash inflows, have solidified our capital position with projected cash reach
for a minimum of twelve months from the date of this report. We believe that careful, focussed and output-oriented cash management is critical.
Financial performance
Grant income for FY16 was
A$887,083 (FY15 A$1,167,190) relate to grants received from Australian Research and Development Rebates, France s Cr dit d Imp t Recherche, and Saxony Development Bank ( S chsische Aufbaubank ) from Germany. The
reduction in grant income for the year is in line with a reduction in Research & Development expenditure compared to the prior year. It is expected that grant income will increase in FY17 in line with an increase in Research and Development
expenditure as the Company progresses its clinical trials in IMP321.
The total corporate administrative expense for FY16 was A$6,982,629 (FY15:
A$5,723,106). This increase in administrative expenses is primarily attributable to an increase in employee share-based payment expenses during the year of A$1,976,417 (FY15: A$738,799) with other expenses remaining consistent with the prior year.
The R&D expenses in FY16 have been dominated by the two IMP321 related clinical trials, AIPAC and TACTI-mel, mostly related to contracts with our clinical research organisations. Despite initiation of these two new trials, R&D expenses (of
A$7,059,528) decreased compared to the previous year (FY15: A$8,952,447). This is principally due to cessation of the costly CVac clinical trials and careful management of our cash resources.
During the year there was an expense of A$542,075 (FY15: A$Nil) in relation to changes in fair value of a comparability milestone. This relates to an amount
paid into a retention account on the acquisition of Immutep which was measured through fair value through profit and loss subsequent to the acquisition in accordance with applicable accounting standards. Refer to note 21 for further information.
The net change in fair value of convertible note liability of A$607,637 (FY15: A$Nil) was attributable to the liability component of the convertible note
being measured at fair value as required by AASB 2. Refer to note 15 for further information.
The loss after tax for FY16 was A$62,015,184 compared to
A$32,151,696 in FY15. The increase was attributable to non-cash financing costs, including a share-based payment to a strategic investor (Ridgeback Capital Investments) and non-cash changes in the fair value of the financial liability. Removing the
impact of those two non-cash items results in a loss after tax for FY16 of A$13,939,476. This loss is 0.91% higher when compared to the adjusted previous period loss of A$13,813,681 after removing non-cash financing costs of A$18,338,015.
With careful financial management Prima remains in a very solid financial position with a cash balance of
A$20,879,548 as at 30 June 2016. We anticipate being able to prolong our cash reach to at least the fourth quarter of calendar year 2017. This extended cash reach does not include potential milestone payments from existing partnerships, which,
if received, would extend our cash reach even further.
Strategic development and risks
Our main focus for FY16 was our LAG-3 programs. We have made significant progress in maintaining our position as the global leader in developing LAG-3 related
We believe the prominence of LAG-3 as an attractive scientific and clinical target has been increasing in the pharmaceutical and
biotech industry. In addition to IMP321, there are several clinical and pre-clinical programs underway, including those of our partners Novartis and GlaxoSmithKline. New clinical trials have been initiated in the past 12 months so that more patients
have the chance to benefit from LAG-3 related treatments. Given this strong industry interest, we believe that LAG-3 may follow the success of PD-1 and CTLA-4 related products.
In the past few months we have commenced two new clinical trials, AIPAC and TACTI-mel. AIPAC is the acronym for Prima s multicentre, Phase IIb,
randomised, double-blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3 Ig fusion protein) or placebo, as an adjunctive to a standard chemotherapy treatment regimen of paclitaxel.
The primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint in this patient population. The first results have been reported in June 2016 with the
product being safe and well tolerated. This clinical trial is focussed on Europe with the study currently active in Belgium, the Netherlands and Hungary. The initial results of all 15 patients from the safety run-in phase of AIPAC are expected to be
presented in the fourth quarter of calandar year 2016.
TACTI-mel (Two ACTive Immunotherapeutics in melanoma) is a multicentre, open label,
Phase I study in which patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor. The study will evaluate safety as the primary endpoint and anti-tumour activity and the immune
response to the combination as secondary endpoints. The focus of this clinical trial is Australia.
The Company s intellectual property position has
been further strengthened by patent grants which included a Japanese patent related to IMP321 granted in May 2016.
In February 2016, CVac, our main
product in previous years, was licensed to Sydys Corporation, Inc. Sydys is an Over-The-Counter (OTC) publicly traded company based in New York that has been repurposed as a clinical stage biotechnology company in order develop the licensed CVac
In this spin out transaction Prima received a 9.9% equity stake in Sydys as consideration for the assets being transferred. Given the significant
capital requirements for conducting clinical trials, no upfront payment was paid; however, should CVac be successfully commercialized, if Sydys is able to secure sufficient funding for the commercialisation, Prima could receive development,
regulatory and commercial milestone payments upon the achievement of set commercial sales targets, in addition to low single digit royalties on sales. This transaction allows Prima to fully concentrate on its highly prospective LAG-3 related
A biotech company like Prima BioMed is exposed to a number of risks: There can be no guarantee that our manufacturing, research, regulatory and
clinical development is successful or can be carried out in the anticipated timelines or that our intellectual property position will be strengthened or not harmed or that our existing partnerships or potential new ones will be successful. In
addition the Company will require additional financing in the future and in fact as the Company has a history of operating losses and may not achieve or maintain profitability in the future, future cash needs are not unlikely.
Business Development
Our commercial partners, Novartis
Last updated: Sep 1, 2016