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IMMUTEP LIMITED — Annual Report 2007
Aug 29, 2007
65122_rns_2007-08-29_c21e8a3e-3cd4-4a43-b708-5d8a7a220236.pdf
Annual Report
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Appendix 4E Preliminary Financial Report
for the year ended 30 June 2007 (and previous corresponding period: year ended 30 June 2006)
In compliance with Listing Rule 4.3A
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ABN 90 009 237 889
Appendix 4E for the Year Ended 30 June 2007
Results for announcement to the market
Current Reporting Period - Year Ended 30 June 2007 Previous Reporting Period - Year Ended 30 June 2006
| down 95.97% to reduced by 26.20% to reduced by 26.20% to $156,122 ($3,138,977) ($3,138,977) Revenues Loss after tax attributable to members Net loss for theperiod attributable to members |
down 95.97% to reduced by 26.20% to reduced by 26.20% to $156,122 ($3,138,977) ($3,138,977) Revenues Loss after tax attributable to members Net loss for theperiod attributable to members |
down 95.97% to reduced by 26.20% to reduced by 26.20% to $156,122 ($3,138,977) ($3,138,977) Revenues Loss after tax attributable to members Net loss for theperiod attributable to members |
|---|---|---|
| Dividends(distribution) | Amountper Security | Franked Amount |
| Final dividend | n/a | n/a |
| Previous corresponding period | n/a | n/a |
| As at 30 June 2007 As at 30 June 2006 Net Tangible Asset per Security (cents per security) 1.74 3.20 Record date for determining entitlements to the dividend, (in the case of a trust, distribution) n/a Explanation of the above information: Refer to the directors' Report - Review of Operations. |
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ABN 90 009 237 889
DIRECTORS' REPORT
Your directors present their report on the economic entity consisting of Prima Biomed Ltd and the entities it controlled at the end of, or during, the year ended 30 June 2007.
Directors
The following persons were directors of Prima Biomed Ltd during the whole of the financial year and up to the date of this report:
Mr Eugene Kopp Executive Chairman & Acting Chief Executive Officer Dr Richard Hammel Non-Executive Director Dr John Sime Non-Executive Director Mr Marcus Clark Retired 30-Nov-06 Chief Executive Officer & Executive Director Dr George Mihaly Retired 22-Dec-06 Non-Executive Director
Review of Operations
Key Objectives for PRR for 2006/07 Financial Year
-
Completion of Cancer Vac Statistical Analysis Report (SAR) for Phase IIa trial in ovarian cancer.
-
Completion of Cancer Vac Clinical Study Report (CSR) for Phase II a trial in ovarian cancer.
-
Completion of GAP analysis for Cancer Vac for Phase IIb trial.
-
Capital Raising for Phase IIb trial of CVac[TM] in Ovarian Cancer in the Australian Market.
-
Completion of a Variation to the Biomira Inc Licence for Cancer Vac.
-
Execute a trade sale or collaboration for the DCtag[TM ] program.
-
Completion of animal studies by Medarex with anti cripto antibodies.
The SAR for the Phase IIa trial Can 002 was completed and announced in March 2007.
Regulatory advisers to undertake the GAP analysis were scrutinised and selected but a recommendation has not been made to the Board to proceed due to funding constraints.
The Biomira Licence was successfully renegotiated, with significant reductions in milestone payments as clinical trials progress in the USA and any royalty’s payable on registration of CVac product by the US FDA.
The Panvax DCtag[TM] program was not successful in attracting investment or interest by third parties in buying or licensing its assets.
PRR was unsuccessful in attracting further investment from any Australian sources in relation to proposed follow up clinical trials for Cvac.
PRR Board undertook an exhaustive review of trade sale options of its key assets.
R&D Programs
No research or development work was carried out on the programs of the subsidiaries except for the clinical trials work which is described below.
CVac[TM]
The SAR for the CVac Phase IIa trial in 21 late stage ovarian cancer patients was completed in March 2007. The results announced on 14 March 2007 indicated CVac[TM] produced overall response rates of 19% and that no significant adverse reactions were recorded. There was clear clinical benefit to patients including those that were heavily pre-treated. The CSR was officially finalised after the end of the financial year.
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ABN 90 009 237 889
Discussions progressed with a number of regulatory consultants to conduct a GAP analysis on the Cancer Vac data to assess what needs to be done in order to facilitate filing an IND in the US market to progress development of CVac[TM] at an internationally competitive level.
In February 2007, Prima announced that it had successfully negotiated a licence variation with Biomira Inc (Biomira) to secure worldwide rights to the use of Mucin-1 for the commercialisation of CVac[TM] . Biomira previously held option rights to commercialise CVac[TM] outside of Australia and New Zealand. Milestone and Royalty payments payable to Biomira have been significantly reduced as a result.
Anti Cripto Antibodies
To date, development partner, Medarex Inc (Medarex), have generated a panel of 60 antibodies which have been characterised in vitro. Four of these antibodies have been further tested in xenograft models of cancer demonstrating anti-tumour activity. Due to a change of internal focus, Medarex have decided not to pursue development of the antibodies. Oncomab is in the process of engaging interested third parties to assess the development potential of the anti cancer antibodies. A trade sale or out-licencing deal would be considered.
DCtag[TM ]
Panvax Pty Ltd was unsuccessful in identifying any commercial interest in the DCtag[TM] technology. Considerable interest exists in a biodegradable particle however more work needs to be conducted to achieve formal proof of concept.
The biodegradable particle program was the subject of a Biotechnology Innovation Fund (BIF) grant from AusIndustry. This program was mutually terminated in July 2007 due to technical issues and an inability to source further biodegradable particles in sufficient time to complete the program within the time constraints of the grant. The results produced under the program showed promise but insufficient data was generated to produce statistically analysable results.
Intellectual Property
As of 30 June 2007 Prima held, 26 granted patents, 1 allowed patent and 31 applications.
In the past 12 months, the Company has had the following patents granted to its subsidiaries:
-
Cancer Vac[TM] – a patent covering the mucin-1 antigen conjugated to oxidised mannan was granted in Japan in November 2006.
-
Panvax – a patent covering a divisional application to the DCtag[TM] technology was granted in August 2006. The divisional application was filed to obtain coverage of the use of naked (unconjugated) beads to enhance immune responses in the absence of an antigen. This patent provides DCtag[TM ] with 2 approaches to generating an immune response.
-
Oncomab – a patent to anti cripto 1 antibodies was granted in New Zealand in July 2006. A patent in Australia was allowed in January 2007 and proceeded to grant in July 2007. The patents provide coverage to antibodies that bind to cripto-1, a marker that is over expressed in many cancer cell types.
A PCT application for Panvax Family 2 was allowed to lapse in February 2007 due to lack of commercial interest.
Financial
Revenues at $0.156m were significantly reduced due to the sale of Arthron’s IP assets to Trillium Therapeutics Inc. in 2006. In 2007 revenue was gained from interest and through Biotechnology Innovation Fund (BIF) grants from the Commonwealth Government.
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ABN 90 009 237 889
Operating costs were down compared to the previous year. The key contributors to that result came from:
-
R&D decreased by $1.785m due to a reduction in expenses driven by completion of the phase IIa
-
· clinical trial and containment of costs in the other non-core R&D programs.
-
Corporate and Business Development expenses decreased by $1.118m due to reduction in staff
-
· costs of $0.268m, reduction in legal costs of $0.332m and reduction on other costs and overheads of $0.518m.
The investment in the Trillium Therapeutics Inc was re-valued to $2.982m based on a recent small capital raising by Trillium adjusted for year-end exchange rate differences. This resulted in an impairment loss of $0.267m.
The Company raised $0.922m after costs from a private placement of shares in November 2006.
Overall the result was a loss of $3.139m compared to a loss for the previous year of $4.253m.
The Company has secured $0.500m funding which it can take up at its election.
Outlook
Prima has completed a review of potential funding sources and is engaged in preliminary confidential discussions with several International and Australian companies with a view to possible sale of the assets of its subsidiaries. The Company anticipates that over the course of the next two quarters an announcement will be made about any disposals of assets of one or more of its subsidiaries’.
Eugene Kopp
Executive Chairman and Acting Chief Executive Officer
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ABN 90 009 237 889
CONSOLIDATED INCOME STATEMENT FOR THE YEAR ENDED 30 JUNE 2007
| Notes Diluted loss per share Loss per share attributable to the ordinary equity holders of the Company, from overall operations Revenue LOSS BEFORE INCOME TAX Basic loss per share INCOME TAX EXPENSE LOSS ATTRIBUTABLE TO MEMBERS OF THE PARENT ENTITY LOSS FOR THE PERIOD Gross Profit LOSS ATTRIBUTABLE TO MINORITY INTEREST Research and Development Corporate Administration Auditor's Remuneration Depreciation Amortisation Intellectual Property Business Development Losses Borne by Parent Entity Impairment of Assets Goodwill Impairment |
30 June 2007 $ 30 June 2006 3,876,910 156,122 3,876,910 $ Economic Entity (1.68) (1.68) Cents (2.45) (2.45) (4,357,874) (3,139,034) (3,139,034) - Cents (3,138,977) 156,122 57 104,401 (4,357,874) - (4,253,473) (974,404) (1,503,626) (2,096,506) (14,782) (44,260) (13,875) (54,850) (56,436) (2,373,210) (2,759,775) (214,735) (105,470) - (559,020) (139,660) (310,167) - 376 (267,604) (41,936) |
30 June 2007 $ 30 June 2006 3,876,910 156,122 3,876,910 $ Economic Entity (1.68) (1.68) Cents (2.45) (2.45) (4,357,874) (3,139,034) (3,139,034) - Cents (3,138,977) 156,122 57 104,401 (4,357,874) - (4,253,473) (974,404) (1,503,626) (2,096,506) (14,782) (44,260) (13,875) (54,850) (56,436) (2,373,210) (2,759,775) (214,735) (105,470) - (559,020) (139,660) (310,167) - 376 (267,604) (41,936) |
|---|---|---|
| 3,876,910 (2,096,506) (14,782) (54,850) (56,436) (2,373,210) (2,759,775) (214,735) (105,470) - (559,020) |
||
| (4,357,874) - |
||
| 104,401 (4,357,874) |
||
| (4,253,473) | ||
| (2.45) (2.45) Cents |
The accompanying notes form part of these financial statements.
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ABN 90 009 237 889
CONSOLIDATED BALANCE SHEET AS AT 30 JUNE 2007
| Note CURRENT ASSETS Cash and Cash Equivalents TOTAL CURRENT ASSETS Other Current Assets TOTAL NON-CURRENT NET ASSETS Minority Equity Interest Issued Capital EQUITY Trade and Other Receivables Intangible Assets NON-CURRENT ASSETS Plant and Equipment Other Financial Assets CURRENT LIABILITIES TOTAL NON-CURRENT ASSETS Trade and Other Payables TOTAL ASSETS Provisions NON-CURRENT LIABILITIES TOTAL CURRENT LIABILITIES Provisions Accumulated Losses TOTAL LIABILITIES TOTAL EQUITY Total Parent Entity Interest in Equity |
671,780 3,211,349 70 68,486 112,095 46,832 2,981,516 3,249,120 51,325 35,942 17,116 17,009 278,207 1,043,326 123 (30,825,665) 37,141,706 38,044,589 4,079,947 6,316,041 704,281 3,391,930 $ 32,431 $ 261,091 1,026,317 4,358,277 3,967,994 625,648 667,584 225,149 974,992 17,116 17,009 4,080,070 6,316,598 (33,964,642) 4,080,070 6,316,598 557 Economic Entity 30 June 2007 30 June 2006 51,290 7,359,924 3,653,996 |
671,780 3,211,349 70 68,486 112,095 46,832 2,981,516 3,249,120 51,325 35,942 17,116 17,009 278,207 1,043,326 123 (30,825,665) 37,141,706 38,044,589 4,079,947 6,316,041 704,281 3,391,930 $ 32,431 $ 261,091 1,026,317 4,358,277 3,967,994 625,648 667,584 225,149 974,992 17,116 17,009 4,080,070 6,316,598 (33,964,642) 4,080,070 6,316,598 557 Economic Entity 30 June 2007 30 June 2006 51,290 7,359,924 3,653,996 |
|---|---|---|
| 3,391,930 | ||
| 3,249,120 667,584 51,290 |
||
| 3,967,994 | ||
| 7,359,924 | ||
| 51,325 974,992 |
||
| 1,026,317 | ||
| 17,009 | ||
| 17,009 | ||
| 1,043,326 | ||
| 6,316,598 | ||
| (30,825,665) 37,141,706 |
||
| 6,316,041 | ||
| 557 | ||
| 6,316,598 |
The accompanying notes form part of these financial statements.
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ABN 90 009 237 889
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED 30 JUNE 2007
Economic Entity
| Minority | |||||
|---|---|---|---|---|---|
| Equity | |||||
| Issued Capital | Accumulated Losses | Interest | Total | ||
| $ | $ | $ | $ | ||
| Balance at 30 June 2005 | 34,915,293 | (26,572,192) | - | 8,343,101 | |
| Shares issued net of costs | 2,094,753 |
- | - | 2,094,753 | |
| Options issued | 131,660 |
- | - | 131,660 | |
| Net (Loss) for the period | - | (4,253,473) | - | (4,253,473) | |
| Loss attributable to minority | |||||
| shareholders | - |
- | 557 | 557 | |
| Balance at 30 June 2006 | 37,141,706 | (30,825,665) | 557 | 6,316,598 | |
| Shares issued net of costs | 1,003,182 |
- | - | 1,003,182 | |
| Transfer of shares | (122,899) |
- | - | (122,899) | |
| Options issued | 22,600 |
- | - | 22,600 | |
| Net (Loss) for the period | - | (3,138,977) | - | (3,138,977) | |
| Loss attributable to minority | |||||
| shareholders | - |
- | (434) | (434) | |
| Balance at 30 June 2007 | 38,044,589 | (33,964,642) | 123 | 4,080,070 |
The accompanying notes form part of these financial statements.
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ABN 90 009 237 889
CONSOLIDATED CASH FLOW STATEMENT FOR THE YEAR ENDED 30 JUNE 2007
| Note 7 CASH FLOWS RELATED TO OPERATING ACTIVITIES Interest and other items of a similar nature received Grant income Payments to suppliers and employees Licence fee R&D services Proceeds from sale of intellectual property Proceeds from issues of securities NET CASH FLOWS PROVIDED BY / (USED IN) FINANCING ACTIVITIES Cash and cash equivalents at the beginning of the year CASH AND CASH EQUIVALENTS AT THE END OF THE YEAR NET CASH FLOWS USED IN OPERATING ACTIVITIES CASH FLOWS RELATED TO INVESTING ACTIVITIES NET CASH FLOWS PROVIDED BY / (USED IN) INVESTING ACTIVITIES CASH FLOWS RELATED TO FINANCING ACTIVITIES Payment for purchases of plant and equipment NET INCREASE / (DECREASE) IN CASH AND CASH EQUIVALENTS Capital raising costs |
63,599 30 June 2007 65,290 22,864 - (3,329,338) Economic Entity 30 June 2006 $ - 227,591 103,518 268,518 $ (3,455,720) (5,676,640) (19,199) (9,417) 749,914 - 769,113 799,186 (19,925) (2,539,569) (4,321,653) 7,533,002 3,211,349 3,211,349 671,780 (5,051,642) 877,101 - (19,925) (9,417) (77,915) |
63,599 30 June 2007 65,290 22,864 - (3,329,338) Economic Entity 30 June 2006 $ - 227,591 103,518 268,518 $ (3,455,720) (5,676,640) (19,199) (9,417) 749,914 - 769,113 799,186 (19,925) (2,539,569) (4,321,653) 7,533,002 3,211,349 3,211,349 671,780 (5,051,642) 877,101 - (19,925) (9,417) (77,915) |
|---|---|---|
| (5,051,642) | ||
| (19,199) 769,113 |
||
| 749,914 | ||
| - (19,925) |
||
| (19,925) | ||
| (4,321,653) 7,533,002 |
||
| 3,211,349 |
The accompanying notes form part of these financial statements.
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ABN 90 009 237 889
NOTES TO THE FINANCIAL STATEMENTS
Note 1. Basis of Preparation
The financial report is a general purpose financial report which has been prepared in accordance with the Corporations Act 2001, Accounting Standards and Urgent Issues Group Interpretations, and complies with other requirements of the law. Accounting Standards include Australian equivalents to International Financial Reporting Standards ("A-IFRS"). Compliance with A-IFRS ensure that the consolidated financial statements and notes of the consolidated entity comply with International Financial Reporting Standards ("IFRS").
The accounting policies adopted are consistent with those of the previous financial year.
Note 2. Dividends
The Company resolved not to declare any dividends in the period ended 30 June 2007.
Note 3. Segment Information
(a) Primary Reporting Format - Business Segments
| 30 June 2007 | Cancer | Anti- | Drug | Therapeuti | Elimination | Consolidat |
|---|---|---|---|---|---|---|
| Immuno- | Inflammat | Delivery | c | ed | ||
| Therapy | ory | Systems | Antibodies | |||
| for Cancer | ||||||
| $ | $ | $ | $ | $ | $ | |
| External Sales | 1,635 | 7,292 | 22,842 | 22 | - | 31,791 |
| Unallocated Revenue | 124,331 | |||||
| Total Segment Revenue/income | 156,122 | |||||
| Segment Result | (1,487,781) | (435,653) | (457,068) | (290,418) | 1,348,763 | (1,322,157) |
| Unallocated Revenue | 124,331 | |||||
| Unallocated Expenses | (1,941,208) | |||||
| Net Loss | (3,139,034) | |||||
| Segment Assets | 419,053 | 2,983,716 | 38,231 | 252,940 | - | 3,693,940 |
| Unallocated Assets | 664,337 | |||||
| Total Assets | 4,358,277 | |||||
| Segment Liabilities | 6,951,122 | 2,028,956 | 3,786,903 | 1,193,071 | (13,843,238) | 116,814 |
| Unallocated Liabilities | 161,393 | |||||
| Total Liabilities | 278,207 | |||||
| Depreciation and Amortisation | 26,119 | - | 921 | 16,152 | 12,619 | 55,811 |
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ABN 90 009 237 889
(a) Primary Reporting Format - Business Segments (continued)
| 30 June 2006 | Cancer | Anti- | Drug | Therapeuti | Elimination | Consolidat |
|---|---|---|---|---|---|---|
| Immuno- | Inflammat | Delivery | c | ed | ||
| Therapy | ory | Systems | Antibodies | |||
| for Cancer | ||||||
| $ | $ | $ | $ | $ | $ | |
| External Sales | 1,832 | 3,500,906 | 122,958 | 33 | - | 3,625,729 |
| Unallocated Revenue | 251,181 | |||||
| Total Segment Revenue/income | 3,876,910 | |||||
| Segment Result | (1,973,965) | 2,584,620 | (1,167,813) | (309,252) | 1,351,641 | 485,231 |
| Unallocated Revenue | 251,181 | |||||
| Unallocated Expenses | (5,094,286) | |||||
| Net Loss | (4,357,874) | |||||
| Segment Assets | 483,783 | 3,408,649 | 86,523 | 262,237 | - | 4,241,192 |
| Unallocated Assets | 3,118,732 | |||||
| Total Assets | 7,359,924 | |||||
| Segment Liabilities | 5,528,071 | 2,018,237 | 3,378,127 | 911,949 | (11,258,713) | 577,671 |
| Unallocated Liabilities | 465,655 | |||||
| Total Liabilities | 1,043,326 | |||||
| Depreciation and Amortisation | 26,119 | 14,500 | 1,594 | 16,152 | 12,853 | 71,218 |
(b) Secondary Reporting Format - Geographical Segments
The economic entity operated in one geographical location, being Australia in the financial years 2006 & 2007.
Note 4. Contingent Liabilities
There has been no change in contingent liabilities since the last annual reporting date.
Note 5. Issued Capital
| Note 5. Issued Capital | |
|---|---|
| No. $ No. 37,825,332 219,257 38,044,589 176,630,535 30 June 2007 Total Issued Capital 198,053,275 11,250,000 Issued and Paid Up Capital Fully Paid Ordinary Shares Options over Fully Paid Ordinary Shares 50,906,155 |
$ 36,940,829 200,877 30 June 2006 |
| 37,141,706 |
During the half year ended 30 June 2007, the following movements in equity occurred:
Shares
20,000,000 Private placement 902,500 Shares issued to directors 520,240 Shares issued to employees
Options
5,000,000 Private placement fee 50,000 Options issued to employee (44,706,155) Options lapsed
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ABN 90 009 237 889
Note 6. Net Tangible Assets
| 198,053,275 - Add back equity issued for nil consideration Add back sale of intellectual property Add back provisions for employee leave 103,696 30 June 2007 30 June 2007 Add back minority equity interest (57) $3,454,422 (a) Reconciliation of Cash Flow from Operating Activities with Net Loss after Income Tax (3,138,977) Add back goodwill impairment - Add back amortisation expense Add back loss borne by parent Add back depreciation expense Shares (number) Net Tangible Assets 13,875 68,416 (15,276) 41,936 Add back impairment of investments (Increases)/Decreases in Trade and Other Receivables 1.74 (749,843) (Increases)/Decreases in Other Current Assets Increases/(Decreases) in Trade and Other Payables 267,604 671,780 NET CASH FLOWS USED IN OPERATING ACTIVITIES (b) Reconciliation of Cash and Cash Equivalents Cash and cash equivalents at the end of the financial year as shown in the Cash Flow Statement is reconciled to items in the Balance Sheet as follows: (3,329,338) Net Tangible Assets (cents) Note 7. Cash Flow Reconciliation (376) $ Loss after income tax expense Cash and Cash Equivalents 79,664 |
(3,632,719) $5,649,014 149,318 30 June 2006 30 June 2006 (104,401) 176,630,535 3.20 (4,253,473) 2,096,506 14,782 210,139 105,470 143,121 5,457 - $ 249,758 (35,600) |
|---|---|
| (5,051,642) | |
| 3,211,349 |
Note 8. Events Subsequent to Reporting Date
On 14th August 2007 the Company announced that it had received an Australian patent for methods of treating cancer with antibodies.
Otherwise no matters or circumstances have arisen since the end of the reporting period, not otherwise disclosed in this report, which significantly affected or may significantly affect the operations of the economic entity, the result of those operations or the state of affairs of the economic entity in subsequent financial years.
Note 9. Audit
These accounts are currently in the process of being audited. An Annual Report containing the audit report shall be provided in due course.
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ABN 90 009 237 889