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IMMUTEP LIMITED — Interim / Quarterly Report 2009
Apr 29, 2009
65122_rns_2009-04-29_ffc45b39-7505-436a-8404-4faf13d5db7a.pdf
Interim / Quarterly Report
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Thursday, 30 April 2009
QUARTERLY ACTIVITY REPORT ENDING 31 MARCH 2009
ASX Release Stock Code: PRR
Australian health care company Prima BioMed (Prima) (ASX: PRR) is pleased to provide the following Quarterly Report on its activities for the three month period ending 31 March 2009.
Highlights
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$12M equity funding facility secured
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Second European patent secured for CVac™ ovarian cancer treatment
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Commencement of patient treatment with CVac™ Cancer Therapy Vaccine
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Completion of first Share Purchase Plan
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Continuing towards US FDA approvals process for CVac™
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Progressing commercialisation of CVac™ in Australia
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Success of fellow cancer immune-therapy development company, Nasdaq-listed Dendreon
$12M equity funding facility secured
The Company was delighted to secure a $12 million equity funding facility with investment bank Fortrend Securities Pty Ltd (Fortrend) in March, which will be used to advance the commercialisation of Prima’s headline CVac™ ovarian cancer treatment product.
The funding is to be provided by an equity draw-down facility provided by Fortrend, which will allow Prima to place shares with Fortrend over the next 3 years, and is a major milestone for Prima as it enters the final stages of commercialising of CVac™ ovarian cancer vaccine treatment product into the multibillion dollar global oncology pharmaceutical market.
Second European patent secured for CVac™ ovarian cancer treatment
During the Quarter, Prima’s subsidiary company, Cancer Vac Pty Ltd, was granted a patent covering the administration of CVac™ by the European Patent Office.
The new patent claims create additional value for Prima by extending the patent life of this patent application to 2018, which provides a potential four more years of revenues for the CVac™ product currently under development. (The previously granted patent, 659768, which provides protection for the production of CVac™ will expire in 2014).
The patent will be validated in Austria, Belgium, Switzerland/Lichtenstein, Germany, Denmark, Spain, France, United Kingdom, Ireland, Italy, Luxembourg, The Netherlands and Sweden. The new patent claims are granted under patent number 1027063, entitled “Compositions for immunotherapy”. It provides for the ex vivo application of conjugated vaccine to patient’s own dendritic cells.
Commencement of Patient Treatment with CVac™ Cancer Therapy Vaccine
In March Prima commenced patient treatment of the CVac™ ovarian cancer treatment on selected patients in Australia.
Prima BioMed Ltd , Suite 1, 1233 High Street, Armadale, VIC Australia 3143 Ph: +61 (0)3 9824 5254 Fax: + 61 (0)3 9822 7735
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www.primabiomed.com.au ABN 90 009 237 889
The CVac™ treatment was made through the Australian Government’s Australian Regulatory Control Mechanism’s Special Access Scheme under the Therapeutic Goods Administration. The patient treatment represents another important step in the CVac™ commercialisation process. The Company will update the market on the progress of its patient treatments.
Completion of first Share Purchase Plan
In January the Company announced the completion of its first Share Purchase Plan, which raised $198,000 (representing 39,600,000 ordinary shares)
US FDA approvals process for CVac™
Prima continues to make positive progress towards commercialising CVac™ in line with the world’s most rigorous and stringent benchmark standards, provided by the US FDA.
Late last year it completed a successful pre-Investigational New Drug Application (preIND) meeting with the US FDA in Washington. Subsequent to the end of the March Quarter, the Company commenced its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the CVac™ ovarian cancer treatment. The granting of Investigational New Drug status is a pre-requisite for all new drug applications seeking FDA approval for commercialisation, and is one of the final milestones to be completed by Prima in the commercialisation process for CVac™ .
The Company will now seek to commence its Pivotal Trial with the US FDA in the middle of this year, before seeking FDA approval which will ultimately allow the Company to license the product for commercial use on patients and deliver large scale, long term revenue for the Company.
Commercialisation of CVac™ in Australia
Outside of US FDA protocols, the Company is also working closely with other countries to pursue commercialisation in other jurisdictions, to generate cash flows from CVac™ in an even shorter time frame.
The Company is particularly excited about CVac™ ’s development prospects in Australia and anticipates that in conjunction with the domestic body responsible for Gynaecological and Oncology medical specialists, the Australian and New Zealand Gynaecological Oncology Group (ANZGOG), commercialisation may occur in Australia at an earlier date than in the United States.
Dendreon (Nasdaq: DNDN) completes successful Phase III Trial
Fellow cancer immune-therapy development company Dendreon, which is listed on the Nasdaq in the US (Nasdaq: DNDN) enjoyed strong appreciation in its share price in the latter part of the Quarter in anticipation of the successful completion of its Pivotal Clinical Trial for its product, Provenge, which targets prostate cancer.
Subsequent to the end of the March Quarter, Dendreon confirmed the positive results of the Provenge Pivotal Phase III Trial at the American Urological Association Annual Meeting in New York, which confirmed that Provenge prolonged survival in patients with advanced prostate cancer and validated the ability of a patient's own immune system to fight cancer (according to a Dendreon News Release on April 28).
Prima BioMed Ltd , Suite 1, 1233 High Street, Armadale, VIC Australia 3143 Ph: +61 (0)3 9824 5254 Fax: + 61 (0)3 9822 7735 www.primabiomed.com.au ABN 90 009 237 889
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Corporate Development
Prima will update the market as further information becomes available, and it is the consistent commitment of the board and management to take every opportunity to generate and maximise wealth for the company and its investors.
The company intends principally to do this via the pursuit of a US FDA IND for CVac[TM] and successful partnering of the future clinical trials.
For further information please contact
Martin Rogers Executive Director Prima BioMed Ph: 0428 268 357 E: [email protected] Website: www.primabiomed.com.au
About Prima BioMed
Prima BioMed is an ASX listed Australian health care company. The Company is focused on technologies in the fields of cancer immunotherapy and immunology.
Prima’s lead product is the CVac™ ovarian cancer therapy treatment. The Company is making rapid progress towards commercialising CVac™ into the global multi-billion oncology pharmacy market.
CVac™ is a therapy treatment for ovarian cancer administered post-surgery and postchemotherapy to delay relapse and control metastases. There is a large un-met medical need for new treatments for ovarian cancer which has a very high morbidity rate, and currently there are no maintenance-based therapy products commercially available.
The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.
Prima BioMed Ltd , Suite 1, 1233 High Street, Armadale, VIC Australia 3143 Ph: +61 (0)3 9824 5254 Fax: + 61 (0)3 9822 7735 www.primabiomed.com.au ABN 90 009 237 889
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Appendix 4C Quarterly report for entities admitted on the basis of commitments
Appendix 4C – 3[rd] 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 | 31stMarch 2009 |
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 (9 months) $A’000 |
|
|---|---|---|---|
| - (78) (9) (82) - (119) - 3 (2) - - |
- (293) (84) (260) - (483) - 34 (2) - - |
||
| (287) | (1,088) |
- 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 (9 months) $A’000 |
|
|---|---|---|
| 1.8 Net operating cash flows (carried forward) |
(287) | (1,088) |
| 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 |
- - - - - - - - - - - - - - - |
- - - - - - - - - - - - - - - |
| - | - | |
| (287) | (1,088) | |
| 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 |
- - 125 - - (42) |
193 - 125 - - (47) |
| 83 | 271 | |
| 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 |
(204) 485 - |
(817) 1,098 - |
| 281 | 281 |
- 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 |
|---|---|
| 75 | |
| - |
- 1.26 Explanation necessary for an understanding of the transactions Directors’ 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 |
|---|---|---|
| 1,200 | - | |
| - | - |
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) |
36 | 56 |
| 245 | 429 | |
| - | - | |
| - | - | |
| Total: cash at end of quarter(item 1.22) | 281 | 485 |
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 30[th] April 2009
Print name: Robert Kleine
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The CFO Solution
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
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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.
- See chapter 19 for defined terms.
Appendix 4C Page 5
30/9/2001