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Anteris Technologies Global Corp. — Interim / Quarterly Report 2007
Jul 15, 2007
33869_rns_2007-07-15_160c1233-64f1-4fef-a81f-5eb52f7168e8.pdf
Interim / Quarterly Report
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QUARTERLY REPORT BioMedical Devices and Technologies 3 MONTHS ENDED 30 JUNE 2007
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16 July 2007
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QUARTER HIGHLIGHTS
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Announcement of Share Purchase Plan for eligible shareholders (16 March 2007)
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Celxcel (bioMD’s subsidiary company) - Completion of pre-clinical 200 day Comparative Patch study (14 March 2007)
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Presentation at “The Society for Heart Valve Disease 4th Biennial Meeting” in New York
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Attendance at BIO2007 International Convention
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Presentation at The Australian Gynaecological Endoscopy Society’s XVII Annual Scientific Meeting in Sydney
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Ethics approval for Phase II Human Clinical Trial of ADAPT treated cardiovascular patches
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bioMD Limited ABN 35 088 221 078
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PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au
QUARTERLY REPORT ON ACTIVITIES 3 months ended 30 June 2007
bioMD LIMITED
MANAGING DIRECTOR’S REPORT
It has been a significant and busy quarter for bioMD Limited.
The Company’s major focus, the ADAPT[®] Advanced Tissue Process, received ethics approval for a Phase II Human Clinical Trial. This trial has now cleared all regulatory hurdles in South Africa and is expected to commence before the end of this calendar year.
bioMD considers this achievement to be a critical milestone. Since listing three years ago in the biotechnology sector, the investment markets have become milestone orientated for evaluating intellectual property, and as a result, conceptual based models have received a very high level of scrutiny.
Having managed the initial IPO funds carefully over the past 3 years, the Company’s investment in Celxcel Pty Ltd and the ADAPT[® ] Advanced Tissue Process during the December quarter of 2005 has been responsible for an increased market capitalisation of approximately $6.5 million. At the end of June 2007 bioMD carries a market capitalisation of $12 million.
We were extremely encouraged by the high level of acceptances received for the Share Purchase Plan. A total of $672,500 was raised at $0.10 cents per share from 159 eligible shareholders. In addition, the directors raised an additional $377,500 from private and sophisticated investors.
SOCIETY fOR HEART VALVE DISEASE - PRESENTATION AT bIENNIAL MEETING IN NEw YORk
In April 2007 we announced that Celxcel’s Chief Scientific Officer, Professor Leon Neethling, had been invited to present an oral presentation at the Society for Heart Valve Disease (SHVD) Biennial Meeting in New York.
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Prof. Neethling’s presentation was entitled “Enhanced Durability and Biocompatibility of Decellularised Bovine Pericardium, Crosslinked with an Ultra Low Concentration Monomeric Aldehyde and Treated with ADAPT®.”
This clinical abstract will be published in the Society for Heart Valve Disease Journal.
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After being advised of Prof. Neethling’s selection to present at the SHVD meeting, Michael Bennett, Managing Director of bioMD, said:
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“To be selected by an eminent scientific committee to present at such a prestigious world meeting is not only a major achievement by Prof. Neethling but also shows the level of interest in Celxcel’s ADAPT® Advanced Tissue Process. It is also indicative of the high interest by the world’s experts in Heart Valve Disease to find a process which is both novel and considered a major contibution to providing a long lasting and durable tissue heart valve.”
Prof. Neethling’s invitation to present at this meeting follows closely on the acceptance and publishing of his clinical paper entitled “A Multi-Step Approach in Anti-calcification of Glutaraldehyde- Preserved Bovine Pericardium” in the December 2006 edition of “The Journal of Cardiovascular Surgery.”
The ADAPT® Advanced Tissue Process not only has application in heart valve manufacture but has applications in many other surgical specialties such as orthopaedics, abdominal and pelvic floor reconstructions, plastic and reconstructive surgery, and cardiovascular applications where treated biomaterials are used for surgical repair of heart deformities.
PHASE II HUMAN TRIAL Of ADAPT TREATED CARDIOVASCULAR PATCHES
During the quarter bioMD Limited announced it had received ethics approval for a Phase II Human Clinical Trial of cardiovascular patches treated with the ADAPT® Advanced Tissue Process Technology.
Approval from the Ethics Committee of the University of the Free State, Bloemfontein, South Africa is for a Phase II trial of 50 patients suffering from heart deformitites that require surgical reconstruction using a bioimplantable patch.
The patches will be made from bovine pericardium and treated with the ADAPT® Advanced Tissue Process Technology.
bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au
QUARTERLY REPORT ON ACTIVITIES 3 months ended 30 June 2007
bioMD LIMITED
The Phase II trial will be conducted over 12 months with a 12 month follow-up period. The trial’s Chief Investigator, Professor Francis Smit, Head of the Department of Cardiothoracic Surgery at the University of Free State, will lead a team of surgeons who will use the patches to repair defective internal heart tissue structures.
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AUSTRALIAN GYNAECOLOGICAL ENDOSCOPY SOCIETY (“AGES”)
On 17 May, 2007 Dr Georgiou of the Sydney Women’s Endosurgery Centre gave a presentation at the AGES XVII Annual Scientific Meeting in Sydney.
The presentation, entitled “A New Xenograft Mesh”, detailed the application of the ADAPT[® ] Advanced Tissue Process in the production of xenograft biomaterial patches. The patches referred to in this presentation targeted the repair of Soft Tissue Structures in the Pelvic Floor.
Dr Georgiou’s presentation won best presentation in the Best New Technology category.
Universitas Hospital
bioMD will co-ordinate the clinical study which will continue until the last implant has completed the 12 month follow-up period. During the 12 month followup period, all patients will undergo echocardiograph examinations at 6 monthly intervals and selected patients will undergo MRI examinations in addition to normal clinical follow-up.
bioMD’s Managing Director, Michael Bennett said,
“The trial is being conducted at one of South Africa’s leading cardiothoracic hospitals where 50 patients can be selected in a relatively short period of time. South Africa is one of a number of countries that has a high incidence of congential heart disease. The patients will be selected by their diagnostic profile.
This is a very exciting step in the development of the ADAPT ® Advanced Tissue Process. Importantly, it will enable the Company to focus on delivering significant shareholder value through completion of a Phase II human clinical trial.
In addition, it will lay a solid foundation for ongoing discussions with global medical device companies for the use of the ADAPT ® technology.”
The Company will continue its pre-clinical research into the use of the ADAPT® process with other tissue types and their subsequent use as bioimplants in various surgical specialties for use as bioimplants in alternative areas of the human body.
bIO2007 INTERNATIONAL CONVENTION
The Company attended this year’s BIO2007 International Convention held in Boston, USA during the month of May 2007. This is the world’s premier biotechnology conference and exhibition, and draws international participation from industry, government and academia.
bioMD participated in the Australian Pavilion, which included 40 exhibitors representing Australian bioscience companies and Auutralian State and Territory agencies.
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bioMD Limited ABN 35 088 221 078
PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au
QUARTERLY REPORT ON ACTIVITIES 3 months ended 30 June 2007
bioMD LIMITED
SHARE PURCHASE PLAN AND PLACEMENT
bioMD announced the successful completion of its Share Purchase Plan (“SPP”) on 7 May, 2007. A total of $672,500 was raised at A$0.10 per share for the issue of 6,725,000 ordinary shares. 159 eligible shareholders subscribed to the offer.
The Directors raised an additional $377,500 in accordance with ASX Listing Rule 7.1 with the placement of 3,775,000 ordinary shares at A$0.10 to private and sophisticated investors on 12 June, 2007.
CORPORATE OVERVIEw
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bioMD’s market capitalisation at the end of the reported period was $12 million, based on a closing price of 14 cents.
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The consolidated group has $2.1 million in cash reserves and an average burn rate of $147,000 per month for the 12 months to 30 June 2007.
The proceeds of the SPP and placement will be used for additional working capital purposes and to advance development of the ADAPT® technology.
The Directors extend their appreciation to shareholders for their participation in the SPP and continuing support of the Company.
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Issued capital as at 30 June 2007 was 84,308,356 ordinary shares.
bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au
Appendix 4C
Quarterly report for entities admitted on the basis of commitments
Introduced 31/3/2000. Amended 30/9/2001
| Name of entity | |
|---|---|
| bioMD Limited | |
| ABN 36 088 221 078 |
Quarter ended (“current quarter”) |
| 36 088 221 078 | 30 June 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 - ATO refunds Net operating cash flows |
Current quarter $A’000 |
Year to date (12 months) $A’000 |
|---|---|---|
| - (14) - (13) - (368) - 21 - - 20 |
- (57) - (275) - (1,255) - 100 - - 81 |
|
| (354) | (1,406) |
| Current quarter $A’000 |
Year to date (12 months) $A’000 |
|
|---|---|---|
| 1.8 Net operating cash flows (carried forward) |
(354) | (1,406) |
| 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 |
- - - - (145) - - - - - - - - |
(147) - - (7) (167) - - - - - - - - |
| (145) | (321) | |
| (499) | (1,727) | |
| Cash flows related to financing activities 1.15 Proceeds from issues of shares, options, etc. 1.16 Proceeds from sale of forfeited shares 1.17 Proceeds from borrowings 1.18 Repayment of borrowings 1.19 Dividends paid 1.20 Other - option issue costs Net financing cash flows |
1,140 - - - - - |
1,140 - - (11) - - |
| 1,140 | 1,129 | |
| 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 of quarter |
641 1,506 - |
(598) 2,745 - |
| 2,147 | 2,147 |
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 |
Aggregate amount of payments to the parties included in item 1.2 Aggregate amount of loans to the parties included in item 1.11 |
Current quarter $A'000 |
|---|---|---|
| 128 | ||
| - | ||
| 1.26 | Explanation necessaryfor an understandingof the transactions | |
| Consultancy services and superannuation contributions. |
Non-cash financing and investing activities
- 2.1 Details of financing and investing transactions which have had a material effect on consolidated assets and liabilities but did not involve cash flows
N/A
- 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
N/A
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 | ||
|---|---|---|
| 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) |
1,447 | 441 |
| 700 | 1,065 | |
| - | - | |
| - | - | |
| Total: cash at end of quarter(item 1.23) | 2,147 | 1,506 |
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)) |
|---|---|---|
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.
-
2 This statement does ~~/does not*~~ (delete one) give a true and fair view of the matters disclosed.
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Sign here: ............................................................ Date: .......16 July 2007 (Company Secretary)
Print name: .........Caroline L Bentley................................................