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IMMUTEP LIMITED — Interim / Quarterly Report 2008
Jan 30, 2008
65122_rns_2008-01-30_be61df96-6006-4672-9f8f-4935c41368d8.pdf
Interim / Quarterly Report
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Thursday, 31 January 2008
Quarterly Activity Report ending 31 December 2007
ASX Release Stock Code: PRR
Highlights
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Pro rata share offer capital raising complete
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Transition team and retirement of Mr. Eugene Kopp
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GAP Analysis and preparation for US Regulatory discussions
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Consolidation phase of the business
Capital Raising
During the quarter Prima Biomed Ltd (“Prima”, “the Company”) secured new capital to fund its priority CVac[TM] technology as it reviews US regulatory requirements for ongoing clinical development of CVac[TM] for ovarian cancer. The $1.98M was sourced from a rights issue of shares to shareholders that was fully underwritten by RM Capital Pty Ltd.
The Company has also issued a prospectus for a pro rata offer of options on the basis of 1 option for each 3 shares held at 29 January 2008, and a placement of 40 million options, to raise approximately $698,000 (before costs of the offers). The options have an issue price of 0.5 cents, an exercise price of 2.5 cents and an expiry date of 31 December 2011.
Personnel
Prima welcomes two additions to the board as it undergoes a transition and consolidation of the Company’s technologies. Mr. Ata Gokyildirim and Mr. Martin Rogers join the board to fulfil the role in this transition and provide a fresh perspective to our technologies. Mr Eugene Kopp retired from the role of Chairman and as a director, and the board wishes to thank him for his contribution to the company over the past three years. Mr Phillip Hains retired from the role of Finance Director and continues in the role of joint Company Secretary.
GAP Analysis and preparation for US Regulatory Approval
As stated previously, the company wishes to align its future clinical development of CVac[TM] with the requirements of the US drug regulator, the USA Food and Drug Administration (FDA). During the quarter the company selected a US based Clinical Research Organisation (CRO) to evaluate the existing clinical data package and its alignment to US requirements. Formal engagement of the CRO and the results of their evaluation will be reported next quarter. If the findings are favourable, the company may then seek to open formal discussions with the FDA in regard to the design of the next clinical trial, currently planned to be a phase IIb study in ovarian cancer.
This program is important to Prima as there is a large unmet medical need for new treatments for ovarian cancer which has a very high morbidity rate due to the insidious nature of the disease that generally results in late diagnosis of the disease. Sadly seventy percent (70%) of patients are diagnosed with stage III or IV disease where the 5yr survival rate is between 10-20%.
The CVac[TM] product is being developed as a maintenance therapy that is most likely to be administered post surgery and chemotherapy to delay relapse and control metastases. There are currently no products available as maintenance based therapies for ovarian cancer. The potential competitive advantage of CVac[TM] is sought to be created primarily through three key areas, the targeted product features, the proposed therapeutic approach and barriers to entry generated by intellectual property and licensing agreements.
The global market for ovarian cancer therapeutics has shown consistent growth, currently valued in 2007 at US$2.1 billion and is expected to total US$3.6 billion by 2010. Seeking regulatory approval over the next 6-9 months to conduct the next clinical trial of CVac[TM] is of considerable importance and the core focus for Prima.
CVac[TM] is also potentially useful in the treatment of several other solid tumours including lung, breast, colon, renal and prostate cancer, as it targets a tumour protein, mucin-1, which all these tumours express at relatively high levels.
Consolidation Phase
In line with company strategy, Prima is undergoing a consolidation phase to focus on the core assets before moving forward to ensure a larger company role in the cancer space. As part of this consolidation Prima is looking at non-core assets, in particular
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Potential divestment of the technology under development by Panvax Pty Ltd is under discussion with the founding Inventor.
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Weighing options of the current 7% equity investment in Trillium Therapeutics Inc., a Canadian biotech company specialising in antibody and anti-inflammatory technologies.
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Sale or licensing of Oncomab Pty Ltd technology to an international pharmaceutical or biotechnology company.
Prima is keen to unlock value for shareholders as part of this consolidation phase and is assessing all opportunities.
Prima looks forward to further updating the market in relation to these programs as they develop.
For further information please contact
Ata Gokyildirim Chairman Prima Biomed Ltd Mob: +61 408 685 548 Email: [email protected]
About Prima Biomed Ltd
Prima Biomed (ASX: PRR) is a biotechnology company based in Sydney, Australia. The Company is focused on technologies in the fields of immunology and cancer immunotherapy. Prima is focused on developing a dendritic-cell based immunotherapy targeting mucin-1 tumour expressed antigen. Prima’s lead product, CVac™ has completed Phase IIa clinical development in Ovarian Cancer.
For further information, visit www.primabiomed.com.au
This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing and results of clinical trials, interpretation and implications of such results, availability or adequacy of financing, the sales and marketing of commercial products or the efficacy of products. Although the Company believes that the forward - looking statements contained herein are reasonable, it can give no assurance that the Company’s expectations are correct. All forward - looking statements are expressly qualified in their entirety by this cautionary statement.
Prima BioMed Ltd , Suite 1705, 109 Pitt St, Sydney NSW 2000 AUSTRALIA www.primabiomed.com.au ABN: 90 009 237 889
Appendix 4C Quarterly report for entities admitted on the basis of commitments
Appendix 4C – 2nd Quarter Quarterly report for entities admitted
on the basis of commitments
Introduced 31/3/2000. Amended 30/9/2001
| Name of entity | |
|---|---|
| PrimaBiomedLimited | |
| ABN 90 009 237 889 |
Quarter ended (“current quarter”) |
| 90 009 237 889 | 31stDecember 2007 |
Consolidated statement of cash flows
| Cash flows related to operating activities 1.1 Receipts from customers 1.2 Payments for (a) staff costs (b) advertising and marketing (c) research and development (d) leased assets (e) other working capital 1.3 Dividends received 1.4 Interest and other items of a similar nature received 1.5 Interest and other costs of finance paid 1.6 Income taxes paid 1.7 Other - grants received Net operating cash flows |
Current quarter $A’000 |
Year to date (6 months) $A’000 |
|
|---|---|---|---|
| - (193) - (51) - (139) - 10 - - - |
- (372) - (176) - (321) - 14 - - - |
||
| (373) | (855) |
- See chapter 19 for defined terms.
Appendix 4C Page 1
30/9/2001
Appendix 4C Quarterly report for entities admitted on the basis of commitments
| Current quarter $A’000 |
Year to date (6 months) $A’000 |
|
|---|---|---|
| 1.8 Net operating cash flows (carried forward) |
(373) | (855) |
| Cash flows related to investing activities 1.9 Payment for acquisition of: (a) businesses (item 5) (b) equity investments (c) intellectual property (d) physical non-current assets (e) other non-current assets 1.10 Proceeds from disposal of: (a) businesses (item 5) (b) equity investments (c) intellectual property (d) physical non-current assets (e) other non-current assets 1.11 Loans to other entities 1.12 Loans repaid by other entities 1.13 Other (provide details if material) Net investing cash flows 1.14 Total operating and investing cash flows |
- - - - - - - - - - - - - - - |
- - - - - - - - - - - - - - - |
| - | - | |
| (373) | (855) | |
| Cash flows related to financing activities 1.15 Proceeds from issues of shares, options, etc. 1.16 Transfer of shares 1.17 Proceeds from borrowings 1.18 Repayment of borrowings 1.19 Dividends paid 1.20 Other - capital raising costs Net financing cash flows |
1,981 - - - - (132) |
1,981 - - - - (132) |
| 1,849 | 1,849 | |
| Net increase (decrease) in cash held 1.21 Cash at beginning of quarter/year to date 1.22 Exchange rate adjustments to item 1.20 1.23 Cash at end ofquarter |
1,476 190 - |
994 672 - |
| 1,666 | 1,666 |
- See chapter 19 for defined terms.
Appendix 4C Page 2
30/9/2001
Appendix 4C Quarterly report for entities admitted on the basis of commitments
Payments to directors of the entity and associates of the directors
Payments to related entities of the entity and associates of the related entities
| 1.24 Aggregate amount of payments to the parties included in item 1.2 1.25 Aggregate amount of loans to the parties included in item 1.11 |
Current quarter $A'000 |
|---|---|
| 178 | |
| - |
- 1.26 Explanation necessary for an understanding of the transactions Directors’ fees, administration fees and consulting fees at normal commercial rates
Non-cash financing and investing activities
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2.1 Details of financing and investing transactions which have had a material affect on consolidated Assets and liabilities but did not involve cash flows
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2.2 Details of outlays made by other entities to establish or increase their share in businesses in which the reporting entity has an interest
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See chapter 19 for defined terms.
Appendix 4C Page 3
30/9/2001
Appendix 4C Quarterly report for entities admitted on the basis of commitments
Financing facilities available
Add notes as necessary for an understanding of the position. (See AASB 1026 paragraph 12.2).
| 3.1 Loan facilities 3.2 Credit standby arrangements |
Amount available $A’000 |
Amount used $A’000 |
|---|---|---|
| - | - | |
| - | - |
Reconciliation of cash
| Reconciliation of cash at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts is as follows. |
Current quarter $A’000 |
Previous quarter $A’000 |
|---|---|---|
| 4.1 Cash on hand and at bank 4.2 Deposits at call 4.3 Bank overdraft 4.4 Other (provide details) |
56 | 85 |
| 1,610 | 105 | |
| Total: cash at end of quarter(item 1.22) | 1,666 | 190 |
Acquisitions and disposals of business entities
| 5.1 Name of entity 5.2 Place of incorporation or registration 5.3 Consideration for acquisition or disposal 5.4 Total net assets 5.5 Nature of business |
Acquisitions (Item 1.9(a)) |
Disposals (Item 1.10(a)) |
|---|---|---|
| - | - | |
| - | - | |
| - | - | |
| - | - | |
| - | - |
- See chapter 19 for defined terms.
Appendix 4C Page 4
30/9/2001
Appendix 4C Quarterly report for entities admitted on the basis of commitments
Compliance statement
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1 This statement has been prepared under accounting policies which comply with accounting standards as defined in the Corporations Act (except to the extent that information is not required because of note 2) or other standards acceptable to ASX.
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2 This statement does give a true and fair view of the matters disclosed.
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Sign here: _____ Company secretary
Date: Thursday 31 January 2008
Print name: Robert Kleine
The CFO Solution www.thecfo.com.au
Notes
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The quarterly report provides a basis for informing the market how the entity’s activities have been financed for the past quarter and the effect on its cash position. An entity wanting to disclose additional information is encouraged to do so, in a note or notes attached to this report.
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The definitions in, and provisions of, AASB 1026: Statement of Cash Flows apply to this report except for the paragraphs of the Standard set out below.
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6.2 - reconciliation of cash flows arising from operating activities to operating profit or loss
- 9.2 - itemised disclosure relating to acquisitions
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- 9.4 - itemised disclosure relating to disposals
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12.1(a) - policy for classification of cash items
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• 12.3 - disclosure of restrictions on use of cash • 13.1 - comparative information
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Accounting Standards. ASX will accept, for example, the use of International Accounting Standards for foreign entities. If the standards used do not address a topic, the Australian standard on that topic (if any) must be complied with.
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See chapter 19 for defined terms.
Appendix 4C Page 5
30/9/2001