Neal G. Koller President & Chief Executive Officer
3724a Thomas Point Road Annapolis, Maryland 21403 USA Tel: +1 443 994 0101 Fax: +1 410 990 9817 nkoller@plurogen.com
PluroGen Therapeutics, Inc. 503 Broadleaf Way Charlottesville, Virginia 22911 USA Tel: +1 443 994 0101 Fax: +1 410 990 9817 www.plurogen.com
July 23, 2007
RE: PluroGen Therapeutics Q2 2007 Investor Update
Dear Investor
We hope this 2nd quarter update finds you enjoying the summer. Reflected below are a number of accomplishments since our last update in late March. We feel significant progress has been made.
Q2 '07 Update, Solid steps forward for PluroGen:
Key developments in this most recent quarter:
Generated positive results with our gel technology for improving blood flow in injured tissue
This work supported the filing of a 2nd provisional patent in 2007 on the company’s gel technology platform, PluroGel™. (Our 1st new patent filing on the gel technology relates to the use of PluroGel™ to prevent and treat biofilms)
Generated positive results in Dr. Katz’s lab for enhancing diabetic wound healing using adipose (fat) tissue derived stem cells (ASCs)
This work has supported the filing of 3 patent applications to date, creating a solid foundation of intellectual property for this exciting and cutting-edge technology platform
Regulatory & Clinical
Draft of the FDA Orphan Drug Application for our 1st product is almost complete
Draft of the FDA IND for our 1st product is well underway
Draft of the Skin Irritancy Study is ready to insert into the IND
Continued our regular contact with the FDA following-up the Phase III Clinical Trial Synopsis submission
Reduced the list of potential regulatory partners for Europe to a short list - activities limited to next round of funding
Product Development
The “Key Developments” section (above) discusses our 2 major R&D results this quarter
Initiated negotiations to prototype our next round of products, which are dressings impregnated with our gel products for burns and wounds - activities limited to next round of funding
Initiated negotiations to establish relationships and testing protocols with expert laboratories in the field of bio- films - activities limited to next round of funding.
Initiated partnership/licensing negotiations with a company with intellectual property that may ultimately broaden and/or strengthen claims of our PluroGel™ product pipeline
Intellectual Property
The “Key Developments” section (above) discusses our 2 major patent filings this quarter
2 additional new PluroGen patents on the gel technology platform are in conception stage
Progressed license negotiations for Dr. Katz’s fat-derived stem cell patents, applications and research for wound healing applications with UVA and friendly 3rd party
This represents an exciting, and forward-looking additional wound care platform for PluroGen
Finalized negotiations of a new, more favorable license agreement for the gel technology with UVA, now moving through internal UVA approval process
Manufacturing
DPT Labs completed its plan for formulation and manufacturing scale-up to meet FDA regulations
DPT Labs finalizing scaleable formulation for the our 1st product
Funding
Opened bridge funding round raising and initial USD 150,000.00
The Virginia Active Angel Network completed its investment
Jefferson Corner Group completed its investment
Series A Offering Memorandum nearly complete
Early meetings have been initiated with potential investors, including several VC firms. Discussions are positive but no firm commitments.
Target $7M round to support clinical program and product pipeline development
Other
In mid May we presented at the Bio East conference in Montreal
In late May we presented at the Mid Atlantic Diamond Ventures conference in Philadelphia
In late June we were the expert guest on one of Washington DC’s premier business radio shows, Tomorrow’s Business Today
We would like to thank you for your interest and your investment in PluroGen. With your support, we have been able to move this technology significantly forward and hope this update is informative. If you have any questions please do not hesitate to contact us. We are happy to talk further and provide any answers.