AI assistant
IMMUTEP LIMITED — Interim / Quarterly Report 2012
Oct 20, 2011
65122_rns_2011-10-20_5ab992eb-6e34-4e23-89f6-d48b22a21fd0.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
ASX/Media Release (Code: PRR) 21 October 2011
==> picture [215 x 40] intentionally omitted <==
QUARTERLY ACTIVITY REPORT For Quarter ending 30 September 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 September 2011.
Highlights
-
Progress on Phase III ‘CANVAS’ clinical program for CVac[TM] ovarian cancer vaccine
oCANVAS patient enrolment expected to commence Q4 this year -
Successful progress meeting recently completed with United States FDA
-
German manufacturing authorisation for CVac™ commenced
-
TGA manufacturing inspection completed in Melbourne
-
Full patient enrolment for 60 patient CVac[TM] Phase IIb trial completed
-
Company added to the Standard & Poor's S&P/ASX 300 Index
-
EUR 4.1 million grant awarded to Prima for CVac[TM] development
Progress on Phase III ‘CANVAS’ clinical program for CVac[TM] ovarian cancer vaccine
Prima continues to make strong progress in its late-stage clinical trials for the CVac™ ovarian cancer vaccine, and in September provided a progress report on CVac™’s clinical development program.
Patient enrolment for the Company’s major, Phase III, trial is scheduled to commence in Q4 this year. The Phase III clinical trial has been formally named CANVAS ( CAN cer VA ccine S tudy) and will be referred to as CANVAS going forward.
The Company also completed a successful progress meeting with the US Food and Drug Administration (FDA) regarding the upcoming CANVAS trial. The meeting followed the granting of Scientific Advice for CANVAS (for the European component of the trial) by the European regulator, the European Medicines Agency (EMA) in February – see ASX announcement of 21 February 2011.
In addition, CVac™ manufacturing facilities in Melbourne and Leipzig, Germany have been inspected by the respective regulators. Manufacturing authorisation has been commenced in Germany and a decision from the Therapeutic Goods Administration (TGA) in Australia is expected in the near future.
Full patient enrolment for 60 patient CVac[TM] Phase IIb trial completed
Also in September, the Company announced that it had completed full patient enrolment for the CVac[TM] Phase IIb Trial.
Enrolment for the 60 patient trial commenced in July 2010. In February this year, Prima released details that the first patient cohort in the trial (seven patients) had successfully completed the first treatment with the vaccine, with no therapy-related adverse effects. As a result, the Data Safety Monitoring Board confirmed that the trial was safe to proceed, and the balance of patient enrolment into the randomised component of the trial commenced.
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
==> picture [120 x 23] intentionally omitted <==
The Phase IIb trial is being conducted in five premier sites in Australia and 15 sites across the US. The trial design is a randomised and open label trial, comparing patients who are in remission (after 1st/2nd line active treatment with CVac™) against observed standard of care.
The trial aims to confirm the; manufacturing comparability of multiple sites, potency assay, safety of CVac™ and compare disease progression (PFS) between CVac™ and the control group. The trial will also seek to augment the promising efficacy data generated by previous studies, including the Phase IIa pilot study completed in 2007, on 28 patients.
Company added to Standard & Poor's S&P/ASX 300 Index
During the quarter, the Company was added to the Standard & Poor's S&P/ASX 300 Index (effective from 19 September), as part of Standard & Poor's September quarterly review.
The S&P/ASX 300 Index is comprised principally of the 300 largest and most liquid stocks listed and traded on the Australian Stock Exchange. Inclusion in the S&P/ASX 300 Index is based on certain criteria regarding listing, size and liquidity, and Prima is delighted to have been included in the Index for the first time.
The S&P/ASX 300 Index is designed to address investment managers' needs to benchmark against a portfolio characterised by sufficient size and liquidity. It is a component of the Australian indices that can be utilised as building blocks for portfolio construction.
Standard & Poor's is the leading provider of market indices in Australia, and Prima’s inclusion in the S&P/ASX 300 is a strong validation of its continued growth, and will assist in promoting the Company’s exposure within the Australian equity market.
EUR 4.1 million grant awarded to Prima for CVac[TM] development
In August the Company announced that it had been awarded a EUR 4.1 million grant by the German state of Saxony to fund parts of the CVac™ clinical program in Europe.
The grant came from a merit-based research and development grant program which was designed to provide funding for specific projects which demonstrate the potential to further economic development in Saxony. The grant was provided by the State Ministry for Higher Education, Research and the Arts of Saxony.
Prima and the Fraunhofer Institute of Cell Therapy and Immunology (Fraunhofer IZI) submitted a joint proposal to cover the costs of CVac™ materials and manufacturing, plus staffing costs in Saxony and some clinical procedure costs of the European component of CVac™’s trial process.
Prima and Fraunhofer will be reimbursed for eligible costs as they are incurred during the project. Funds under the grant are provided by the European Union and the state of Saxony.
For further information please contact:
Martin Rogers Chief Executive Officer Prima BioMed Ph: +61 2 9276 1242 E: [email protected] Website: www.primabiomed.com.au
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
==> picture [120 x 23] intentionally omitted <==
About CVac[TM] Ovarian Cancer Treatment
CVac™ is Prima BioMed’s core product. It is a vaccine therapy treatment for ovarian cancer sufferers that is 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 recently completed its Phase IIb trial for CVac™ with the US FDA and plans to commence CANVAS( CAN cer VA ccine S tudy) a multinational, multi-centre, randomised, doubleblinded, placebo-controlled trial of CVac™ in Europe and the US this year. The Phase IIb and CANVAS 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[1] .
Regulatory approval and commercialisation of CVac[TM ] is the core focus for Prima.
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 CVac[TM ] ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialization in the United States, Australia, Europe, and globally.
The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.
1 Thomson Business Intelligence, Ovarian Cancer Therapeutics Industry Analysis 2007
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 – 1[st] Quarter
Quarterly Report
For Entities Admitted on the Basis of Commitments
Introduced 31/3/2000. Amended 30/9/2001
Name of Entity: Prima BioMed Ltd (ASX:PRR) ABN: Quarter Ended (“Current Quarter”) 90 009 237 889 30 September 2011
Consolidated Statement of Cash Flows
| Current Quarter | Year-to-Date | |
|---|---|---|
| Cash flows related to operating activities | $A’000 | $A’000 |
| 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 |
- (573) (40) (3,461) - (1,439) - 248 - - - |
- (573) (40) (3,461) - (1,439) - 248 - - - |
| Net operating cash flows | (5,265) | (5,265) |
- 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 |
|
|---|---|---|
| 1.8 Net operating cash flows (carried forward) |
(5,265) | (5,265) |
| 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) |
- - - (129) - - - - - - - - - |
- - - (129) - - - - - - - - - |
| Net investing cash flows | (129) | (129) |
| 1.14 Total operating and investing cash flows | (5,394) | (5,394) |
| 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 1.18 Repayment of borrowings 1.19 Dividends paid 1.20 Other - capital raisingcosts |
569 - - - - - |
569 - - - - - |
| Net financing cash flows | 569 | 569 |
| Net increase (decrease) in cash held | (4,825) | (4,825) |
| 1.21 Cash at beginning of quarter/year to date 1.22 Exchange rate adjustments to item 1.21 |
55,919 16 |
55,919 16 |
| 1.23 Cash at end of quarter | 51,110 | 51,110 |
- 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 |
213 - |
- 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 | 864 | 21,456 | |
| Deposits at call | 13,334 | 24,463 | |
| Bank overdraft | - | - | |
| Other (Term Deposit) | 36,913 | 10,000 | |
| Total: Cash at end of quarter(item 1.23) | 51,110 | 55,919 |
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 21[th] October 2011
==> picture [94 x 55] intentionally omitted <==
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
-
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.
-
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.
-
6.2 - reconciliation of cash flows arising from operating activities to operating profit or loss
-
9.2 - itemised disclosure relating to acquisitions
-
9.4 - itemised disclosure relating to disposals
-
12.1(a) - policy for classification of cash items
-
12.3 - disclosure of restrictions on use of cash
-
13.1 - comparative information
-
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.
30/9/2001
Appendix 4C Page 5