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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
 
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of August 2005
 
Commission File Number 000-51122
 
pSivida Limited
(Translation of registrant’s name into English)
 
Level 12 BGC Centre
28 The Esplanade
Perth WA 6000
(Address of principal executive offices)
 
 
(Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F).
 
Form 20-F ý        Form 40-F o
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes o        No ý
 
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- ___.
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant, pSivida Limited, has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
     
  PSIVIDA LIMITED
 
 		  
 		  
 
Date: August 1, 2005 By:   /s/ Aaron Finlay
 
 
Aaron Finlay
Chief Financial Officer and Company Secretary
 

 
 
 
EXHIBIT INDEX
 
EXHIBIT 99.1:
pSivida quarterly Cashflow - June 2005 Commentary and Highlights
   
EXHIBIT 99.2:
pSivida quarterly Cash Flow Results
 
 

 
 
 
 
EXHIBIT 99.1
 
 
 
ASX RELEASE
29th July 2005
   
pSivida Quarterly Cashflow - June 2005
Commentary and Highlights
Global nanotechnology company pSivida Limited, is pleased to release its quarterly cashflow statement for the quarter ending 30th June 2005.

Highlights and Announcements for the Quarter

Top 5 Global Pharma - significant progress in drug delivery evaluation
pSivida announced that the evaluation of selected compounds from an undisclosed top five global pharmaceutical company has progressed successfully. The collaboration agreement covers a staged evaluation of the pharmaceutical company’s proprietary compounds in pSivida’s porous silicon, controlled release platform (BioSiliconTM). The initial stage of the planned 12-month programme has concluded meeting the agreed technical success criteria, and in turn triggering the next payment to pSivida under the terms of the agreement.

BrachySilTM pancreatic cancer product
Pancreatic cancer is one of the most prevalent cancers with over 232,000 new cases on a global basis per annum (Globocan 2002 statistics) and approximately 60% of new cases occurring in the developed world. With an average five year survival of 4%, pancreatic cancer represents a significant unmet clinical need.

A full development programme of pSivida’s proprietary BrachySilTM product in a second key cancer indication was commenced to evaluate the efficacy and safety of this brachytherapy product in pancreatic cancer, with the clinical programme scheduled to commence before the end of 2005. Selection of this second key indication has resulted from significant independent market research and medical opinion leader feedback and therefore represents a judicious, robust and viable development option.

BrachySil™ cancer therapy achieves primary endpoint in Phase IIa clinical trials liver cancer - Significant efficacy shown
The primary endpoint of the trial was achieved in its key first indication in that BrachySil™ (32-P BioSilicon™) was found to be both safe and well tolerated. The trial was conducted at the Singapore General Hospital on eight patients with advanced liver cancer who were evaluated after three and six months following treatment. Among other key findings of the trial was the finding that BrachySil™ also reduced significantly the size of tumors treated and by up to 100% for smaller tumors even on low dose as determined by CT scanning. These combined results pave the way for a multi-centre Phase IIb dose-profiling study for BrachySil™ in this indication, which is scheduled to begin in the second half of 2005 and for which funding is already in place. This trial will lead to the final registration of BrachySil™ as an approved treatment for liver cancer in 2007.


pSivida and Epitan successfully complete first stage of Proof of Concept Study
The in vivo study conducted at the Institute of Medical and Veterinary Science in Adelaide, South Australia, indicated that a single injection of pSivida’s porous BioSiliconTM technology successfully released MELANOTAN™ over a sustained period. The outcome of this collaboration may lead to a second-generation liquid-based injectable MELANOTAN™ product.

pSivida is granted its first patent in China
This first patent grant in China is important as China has the highest incidence of primary liver cancer in the world with 345,844 cases in 2002. The potential lower cost of the Chinese registration pathway and the vast need of BrachySilTM like products make China an important commercial target.

Roche Diagnostics VP joins pSivida Board
Wholly owned subsidiary AION Diagnostics Limited, appointed Dr. Jörg Schreiber PhD as a Non-executive Director in May. Dr. Schreiber has over 20 years experience in the diagnostics industry principally with Roche Diagnostics and Boehringer Mannheim in Germany and brings with him leadership and expertise in the commercialisation of world class diagnostic products.

pSivida is granted its first patent in South Korea
This is an important patent covering the electronic-based properties of BioSilicon™ in the stimulation of orthopaedic tissue repair and re-engineering where scaffolds are required to support new bone growth. The technology also has application for treatment of fractures that do not heal, such as “bone non-union”. Korea is a key global player in the design and manufacture of micro-components for the electronics industry. This technology, provides the opportunity to capitalize on Korea’s technology strengths as well as the higher margins associated with healthcare products.
 
Post Quarter Highlights and Announcements

pSivida becomes the founding member of the NASDAQ Health Care Index
pSivida’s inclusion on the Health Care Index is recognition of pSivida’s increased visibility in the United States, the world’s largest health care and financial market and follows its recent listing on the Merrill Lynch Nanotechnology Index. The NASDAQ Health Care Index is a market value weighted index that contains NASDAQ-listed companies classified, according to the FTSE Global Classification System, as "Health," "Pharmaceutical" or "Biotechnology." These classifications include health maintenance organisations, hospital management and long-term care, medical equipment and supplies, other health care, biotechnology, and pharmaceutical companies.

pSivida appoints two US based non-Executive Directors in July
Dr. David J. Mazzo was appointed as a Non-executive Director of the company, based in New Jersey, USA. He is President and CEO of Chugai Pharma USA, part of the Roche group of companies and is a subsidiary of Chugai Pharmaceutical Company Limited (Japan), a global research-based pharmaceutical company with sales in 2001 of US$1.7 billion. Dr. Mazzo brings his significant business development experience and pharmaceutical network to the Board and is recognized for his strong scientific and regulatory expertise with broad technical and managerial experience gained from working in a variety of multi-cultural and multi-lingual environments in the USA, Europe and Asia.

Mr. Michael W. Rogers was appointed as a Non-executive Director of the company, based in Massachusetts, USA. He is the Executive Vice-President, Chief Financial Officer and Treasurer of Indevus Pharmaceuticals Incorporated, a biopharmaceutical company based in Lexington, MA. which is engaged in the acquisition, development and commercialisation of products targeting certain medical specialty areas, including urology and infectious diseases. Mr. Rogers brings his significant financing, acquisition, investment banking, and partnering experience relating to pharma and biotech companies to the pSivida Board and will Chair the Audit Committee.

-ENDS-

Released by:
 
pSivida Limited
Brian Leedman
Investor Relations
pSivida Limited
Tel: + 61 8 9226 5099
brianl@psivida.com
US Public Relations
Beverley Jedynak
President
Martin E. Janis & Company, Inc
Tel: +1 (312) 9 1100 ext. 12
bjedynak@janispr.com
UK & Europe Public Relations
Mark Swallow, PhD / Helena Podd
Citigate Dewe Rogerson
Tel: +44 (0)20 7282 2948 / 2867
mark.swallow@citigatedr.co.uk



NOTES TO EDITORS:

pSivida Limited
pSivida is a global nanotechnology company committed to the biomedical sector and the development of products in healthcare. The company’s focus is the development and commercialisation of a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon™. As a new and exciting biocompatible material, BioSilicon™ offers multiple potential applications across the high growth healthcare sector, including controlled release drug delivery, targeted cancer therapies (including brachytherapy and localized chemotherapy), tissue engineering and orthopedics. Potential diagnostics applications are being developed through its subsidiary AION Diagnostics Limited.

pSivida owns the intellectual property rights to BioSilicon™ for use in or on humans and animals. The IP portfolio consists of 26 patent families, 29 granted patents and over 80 patent applications. The core patent, which recognises BioSilicon™ as a biomaterial was granted in the UK in 2000 and in the US in 2001.

pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and in Germany on the Frankfurt Stock Exchange on the XETRA system (German Symbol: PSI. Securities Code (WKN) 358705). pSivida’s shares also trade in the United Kingdom on the OFEX International Market Service (IMS) under the ticker symbol PSD.

The Company’s strategic partner and largest shareholder is the QinetiQ group, the largest science and technology company in Europe. QinetiQ is the former UK government Defence Evaluation Research Agency and was instrumental in discovering BioSilicon™. pSivida enjoys a strong relationship with QinetiQ having access to its cutting edge research and development facilities. For more information on QinetiQ visit www.qinetiq.com.

For more information visit www.psivida.com
 
This document contains forward-looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in such forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Actual results could differ materially from those anticipated in these forward-looking statements due to many important factors including: our failure to develop applications for BioSiliconTM due to regulatory, scientific or other issues. Other reasons are contained in cautionary statements in the Registration Statement on Form 20-F filed with the U.S. Securities and Exchange Commission, including, without limitation, under Item 3.D, "Risk Factors" therein. We do not undertake to update any oral or written forward-looking statements that may be made by or on behalf of pSivida.

 
 
Unassociated Document
EXHIBIT 99.2
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Rule 4.7B
 
Appendix 4C

Quarterly report
for entities admitted
on the basis of commitments

 
Introduced 31/3/2000. Amended 30/9/2001
 
Name of entity
pSivida Limited

ABN
  
Quarter ended (“current quarter”)
98 009 232 026
  
30 June 2005

Consolidated statement of cash flows

 
Cash flows related to operating activities
  
Current quarter
$A’000
  
Year to date
(12 months)
$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
    
(195)
-- 
(2,526)
-- 
(1,085)
 
 
 
 
  
(1,042)
-- 
(8,318)
-- 
(3,774)
 
 
 
1.3
    
Dividends received
    
-- 
   
-- 
 
1.4
    
Interest and other items of a similar nature received
    
119 
   
667 
 
1.5
    
Interest and other costs of finance paid
    
-- 
   
-- 
 
1.6
    
Income taxes paid
    
-- 
   
-- 
 
1.7
    
Other - other income
    
7 
   
162 
 
   
Net operating cash flows 
    
(3,680)
 
  
(12,305)
 
 
+ See chapter 19 for defined terms.

Appendix 4C Page 1
 
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments


       
Current quarter
$A’000
  
Year to date
(12 months)
$A’000
  
1.8
    
Net operating cash flows (carried forward
)
  
(3,680
)
  
(12,305
)
 
    
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
    
--
--
--
(1,183)
--
    
--
--
--
(3,410)
--
  
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 - cash paid for equity increase in controlled entity
    
--
    
(4,645
)
 
    
Net investing cash flows
    
(1,183
)
  
(8,055
)
1.14
    
Total operating and investing cash flows
   
(4,863
)
  
(20,360
)
 
    
Cash flows related to financing activities
              
1.15
    
Proceeds from issues of shares, options, etc.
    
--
    
3,667
  
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 - share issue costs
    
--
    
(28
)
 
    
Net financing cash flows
    
--
    
3,639
  
   
Net increase (decrease) in cash held
    
(4,863
)
  
(16,721
)
1.21
    
Cash at beginning of quarter/year to date
    
17,853
    
31,351
  
1.22
    
Exchange rate adjustments to item 1.20
    
(98
)
  
(1,738
)
1.23
    
Cash at end of quarter
    
12,892
    
12,892
  
 
 
+ See chapter 19 for defined terms.

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

 
Current quarter
$A'000
1.24
Aggregate amount of payments to the parties included in item 1.2
303
1.25
Aggregate amount of loans to the parties included in item 1.11
--
   
1.26
Explanation necessary for an understanding of the transactions
 
1.2(a) Staff costs include consultants and directors’ fees paid by pSivida.
1.2(c) Research and development costs include all expenditure incurred by pSiMedica and pSiOncology.
1.13 Includes amounts transferred for the purposes of funding the research and development activities of pSiMedica.
1.15 $3,666,500 received on the exercise of options with an expiry date of 31 December 2004.
 
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).

   
Amount available
$A’000
Amount used
$A’000
3.1
Loan facilities
--
--
       
3.2
Credit standby arrangements
--
--
 
+ See chapter 19 for defined terms.

 
Appendix 4C page 3
 
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
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
1,663
2,049
4.2
Deposits at call
11,229
15,804
4.3
Bank overdraft
--
--
4.4
Other (provide details)
--
--
 
Total: cash at end of quarter (item 1.22)
12,892
17,853

Acquisitions and disposals of business entities

 
Acquisitions
(Item 1.9(a))
Disposals
(Item 1.10(a))
5.1
Name of entity
N/A
N/A
5.2
Place of incorporation or registration
          
5.3
Consideration for acquisition or disposal
          
5.4
Total net assets
          
5.5
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: 29 July 2005
                   (Company secretary)
 
Print name:  Aaron Finlay
 
+ See chapter 19 for defined terms.

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.

·  
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

3.
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