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IMMUTEP LIMITED Interim / Quarterly Report 2011

Jul 28, 2011

65122_rns_2011-07-28_7c4eb175-cb2c-4744-9ee2-3ce538eacbc7.pdf

Interim / Quarterly Report

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ASX/Media Release (Code: PRR) 29 July 2011

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QUARTERLY ACTIVITY REPORT For Quarter ending 30 June 2011

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 30 June 2011.

Highlights

  • Highly successful Capital Raise raises A$41.25 million

  • A$21M raised in Placement to institutional and sophisticated investors, and

  • $$20.3M raised in a Share Purchase Plan to existing shareholders

  • Potency Assay for CVac[TM] ovarian cancer vaccine successfully developed

  • CVac[TM] Commercialisation plans commenced in the Middle East - CVac[TM] granted approval in Dubai Healthcare City

  • Dr Hind Al Saadi appointed General Manager of Prima’s Middle East operations.

  • Appointment of new Company Secretary

  • Japanese patent awarded for CVac™

____________

A$41.25 million raised in highly successful Capital Raising

In May the Company completed a highly successful Capital Raising which raised a total of A$41.3 million, to provide funding for its late stage trials of the CVac[TM] immunotherapy ovarian cancer vaccine.

The Capital Raising comprised a Placement to institutional and sophisticated investors which raised a total of A$21 million, and a Share Purchase Plan (SPP) to existing shareholders, which raised $20.3 million. Deutsche Bank AG, Sydney Branch, and Ord Minnett Limited were joint lead managers for the Placement.

The price of shares under the Placement and the SPP was 28 cents, which represented a discount of 18.8% to the adjusted volume weighted average price for the five day period up to and including Tuesday 24 May 2011.

The funds raised under the Capital Raising will be used by Prima for its ongoing development of the CVac[TM] immunotherapy ovarian cancer vaccine, including its upcoming Phase III Clinical Trials, and also to provide working capital for the Company. Importantly, the funds raised will cover the forecast costs of the Phase IIb & Phase III trials.

The Company was delighted with the response from investors to its Capital Raising, and thanks all new and existing shareholders for their support of the Capital Raise.

Potency Assay for CVac[TM] ovarian cancer vaccine successfully developed

In June Prima announced that a Potency Assay for the CVac™ immunotherapy ovarian cancer vaccine had been successfully developed.

Prima BioMed Ltd Level 7, 151 Macquarie Street, Sydney 2000 Ph: +61 (0) 2 9276 1224 Fax: +61 (0) 2 9276 1284 www.primabiomed.com.au ABN: 90 009 237 889

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The purpose of a Potency Assay is to ensure that a given batch of treatment (in this case the CVac™ vaccine) has a pre-defined minimum level of potential biological activity that will deliver an expected result. It also helps demonstrate a batch-to-batch consistency of the treatment, which depends on and reflects biological activity.

The development of a Potency Assay is an important step for CVac™. The Potency Assay gives Prima BioMed an opportunity to compare manufacturing across the Company’s world-wide facilities and will lead to a validation tool for regulatory purposes, once patient data from the upcoming Phase III study is available.

The assay is a key component in the process to establish CVac™ as a pharmaceutical grade product, and will become an integral part of the Chemistry Manufacturing and Controls (CMC) section of a future registration regulatory package for CVac™.

CVac[TM] commercialisation plans commenced in the Middle East - CVac[TM] granted approval in Dubai Healthcare City

Also druring the quarter, in May, the Company announced that Dubai Healthcare City (DHCC) had granted approval for the marketing and distribution of the CVac[TM] vaccine in DHCC. It represents the first approval globally to make CVac[TM] commercially available.

The approval of CVac[TM] in DHCC is a major market opportunity for Prima to provide treatment for cancer patients in the Middle Eastern region and generate revenues. Subject to finalising regulatory steps, the first sales of CVac[TM] in DHCC are expected before the end of 2011.

CVac[TM] will be available in DHCC through Prima’s partnership with The City Hospital, a state-of-theart, multi-disciplinary hospital in Dubai. Prima and The City Hospital have signed a Memorandum of Understanding laying out the terms and conditions by which CVac[TM] will be available at The City Hospital. A further agreement between the parties is to be signed in combination with full regulatory approval for CVac[TM] . There is also the potential, in the future, to extend the application of CVac[TM] in Dubai to other mucin-1 positive tumours.

Dr Hind Al Saadi has been appointed as General Manager of Prima BioMed’s Middle East operations and will lead the commercialisation effort for CVac[TM] in the region. Dr Al Saadi is a pharmacist by training and has nearly 20 years industry experience in marketing, sales, distribution, and regulatory affairs. She has previously worked for Baxter Healthcare in New Zealand, as well as Globalpharma and The Center for Healthcare Planning and Quality in Dubai.

Prima awarded Japanese patent for CVac™

In April the Company announced that its subsidiary company, Cancer Vac Pty Ltd, had been granted a patent for CVac™ from the Japanese Patent Office.

The claims secured in patent number 4669930 (entitled, Composition including mannose receptor bearing cell and antigen and immunoregulatory mannose receptor-bearing cell population) provide for the manufacture of mannan fusion protein (MFP) conjugated vaccine to a patient’s own dendritic cells.

The granted patent claims will allow the conjugation of Mucin-1 as well as other cancer antigens to MFP.

Prima intends to file for Orphan Drug Designation for CVac™ in Japan. Orphan Drug Designation provides a period of exclusivity of 10 years from marketing approval date. CVac™ has already received Orphan Drug Designation from the US Food and Drug Administration, and the European Medicines Evaluation Agency.

Prima BioMed Ltd Level 7, 151 Macquarie Street, Sydney 2000 Ph: +61 (0) 2 9276 1224 Fax: +61 (0) 2 9276 1284 www.primabiomed.com.au

ABN: 90 009 237 889

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Appointment of new Company Secretary

In May Prima confirmed the appointment of its Chief Financial Officer, Mr Ian Bangs, as the Company’s new Company Secretary.

Mr Bangs has a strong depth of experience and expertise in the financial management of publicly listed companies, and has previously held the roles of Chief Financial Officer and Company Secretary for a number of ASX-listed companies. These include property and funds management group LandMark White Limited (ASX: LMW) and, prior to that, IFC Capital Limited (ASX: IFC) for six and a half years. He was also the CFO of the Four Seasons Hotel (formerly the Regent Hotel) in Sydney for 10 years.

Mr Bangs has expertise in the day to day financial and administrative operations of companies, together with their statutory reporting and compliance obligations. He has a Bachelor of Commerce degree and is a Fellow CPA.

For further information please contact:

Martin Rogers Chief Executive Officer Prima BioMed Ph: +61 (0) 2 9276 1224 E: [email protected] Website: www.primabiomed.com.au

About CVac™

CVac™ is Prima BioMed’s core product. It is a vaccine therapy treatment for ovarian cancer sufferers that are administered post-surgery and post-chemotherapy to delay the relapse and control the metastases of the cancer. There is a large un-met medical need for new treatments for ovarian cancer which has a very high morbidity rate, and there are currently no maintenance-based therapy products commercially available.

The Company has commenced its Phase IIb Trial for CVac™ with the US FDA and plans to commence a Phase III Clinical Trial for CVac™ in Europe this year. The Phase IIb and Phase III Trials aim to further confirm the ability of CVac™ to reduce the instance of relapse in ovarian cancer patients, control the metastases of the cancer and increase the life expectancy of patients.

Prima’s ultimate goal is to commercialise CVac™ into the multi-billion dollar global pharmacy oncology market. The global market for ovarian cancer therapeutics was valued at US$2.1b in 2007 and was estimated to have grown to US$3.6b by 2010.

Prima BioMed Ltd Level 7, 151 Macquarie Street, Sydney 2000 Ph: +61 (0) 2 9276 1224 Fax: +61 (0) 2 9276 1284 www.primabiomed.com.au

ABN: 90 009 237 889

Appendix 4C Quarterly report for entities admitted on the basis of commitments

Appendix 4C – 4[th] Quarter

Quarterly Report

For Entities Admitted on the Basis of Commitments

Introduced 31/3/2000. Amended 30/9/2001

Name of Entity:
Prima Biomed Limited (ASX:PRR)
ABN:
90 009 237 889
Quarter Ended (“Current Quarter”)
90 009 237 889 30 June 2011

Consolidated Statement of Cash Flows

Current Quarter Year-to-Date
Cash flows related to operating activities $A’000 $A’000
(12 Months)
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
-
(393)
-
(3,086)
-
(990)
-
174
-
-
-
-
(1,429)
(10)
(9,504)
-
(3,067)
-
1,031
-
-
-
Net operating cash flows (4,295) (12,979)
  • See chapter 19 for defined terms.

30/9/2001

Appendix 4C Page 1

Appendix 4C Quarterly report for entities admitted on the basis of commitments

Current Quarter
$A’000
Year-to-Date
$A’000
(12 months)
1.8
Net operating cash flows (carried forward)
(4,295) (12,979)
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)
-
-
-
-
-
-
-
-
-
-
-
-
-
-
(17)
-
(23)
-
-
-
-
-
-
-
-
-
Net investing cash flows - (40)
1.14 Total operating and investing cash flows (4,295) (13,019)
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 net finance costs (*1)
1.18 Repayment of borrowings
1.19 Dividends paid
1.20 Other - capital raisingcosts
45,469
-
-
-
-
(1,359)
50,527
-
4,162
-
-
(1,393)
Net financing cash flows 44,110 53,296
Net increase (decrease) in cash held 39,815 40,277
1.21 Cash at beginning of quarter/year to date
1.22 Exchange rate adjustments to item 1.21
16,100
4
15,638
4
1.23 Cash at end of quarter 55,919 55,919

Note:

  • 1) 1.17 includes funds received from convertible loans that are repaid via equity issue and finance cost in connection with convertible loans that are repaid via equity issue.

  • See chapter 19 for defined terms.

30/9/2001

Appendix 4C Page 2

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
1.25
Current Quarter
$A'000
Aggregate amount of payments to the parties included in item 1.2
Aggregate amount of loans to the parties included in item 1.11
190
-
  • 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

  • 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

  • 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

Financing Facilities Available

Add notes as necessary for an understanding of the position. (See AASB 1026 paragraph 12.2).

3.1
3.2
Amount Available Amount Used
$A’000 $A’000
Loan facilities - -
Credit standby arrangements 12,000* -

Note:

  • 3.2 $12 million equity drawdown facility in place with Foretrend Securities Pty Ltd.

  • See chapter 19 for defined terms.

30/9/2001

Appendix 4C Page 3

Appendix 4C Quarterly report for entities admitted on the basis of commitments

Reconciliation of Cash

Reco
(as s
to th
4.1
4.2
4.3
4.4
nciliation of cash at the end of the quarter
hown in the consolidated statement of cash flows)
e related items in the accounts is as follows.
Current Quarter Previous
Quarter
$A’000 $A’000
Cash on hand and at bank 21,456 1,908
Deposits at call 24,463 4,192
Bank overdraft - -
Other (Term Deposit) 10,000 10,000
Total: Cash at end of quarter(item 1.23) 55,919 16,100

Acquisitions and Disposals of Business Entities

5.1
5.2
5.3
5.4
5.5
Name of entity Acquisitions Disposals
(Item 1.9(a)) (Item 1.10(a))
- -
Place of incorporation or registration - -
Consideration for acquisition or disposal - -
Total net assets - -
Nature of business - -

Compliance Statement

  • 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.

  • 2 This statement does give a true and fair view of the matters disclosed.

Sign Here:

Date: Friday 29[th] July 2011

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Company Secretary

Print Name: Ian Bangs

  • See chapter 19 for defined terms.

30/9/2001

Appendix 4C Page 4

Appendix 4C Quarterly report for entities admitted on the basis of commitments

Notes

  1. 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.

  2. 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.

  3. 6.2 - reconciliation of cash flows arising from operating activities to operating profit or loss

  4. 9.2 - itemised disclosure relating to acquisitions

  5. 9.4 - itemised disclosure relating to disposals

  6. 12.1(a) - policy for classification of cash items

  7. 12.3 - disclosure of restrictions on use of cash

  8. 13.1 - comparative information

  9. 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.

  10. See chapter 19 for defined terms.

30/9/2001

Appendix 4C Page 5