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
August 4, 2008
RE: PluroGen Therapeutics, Inc. Investor Update: Q2 2008
Dear Investor
Once again, PluroGen made important progress in plan achievement in this latest quarter, Q2 2008. The Company achieved a number of important and strategic milestones, which are summarized as follows:
We considerably improved our sales, marketing and distribution capabilities in the US and EU
We enhanced our fund raising position through the release of our Series A preferred stock offering
A number of our convertible note investors have already invested in the Series A
We took a major step towards commercialization with the receipt of our 1st medical device customer order
We made significant progress towards submission of our US and EU medical device regulatory marketing approvals
We made further progress in our intellectual property portfolio
This past quarter has achieved the most significant strategic accomplishments to date. Your support has enabled us to do so.
We hope this update is informative. We are happy to answer any of your questions. Thank you for your interest and your investment.
Q2 2008 Investor Update
PluroGen Milestones and Accomplishment
Commercial Partner Activities and Product Development
PluroGen signed a Letter of Intent with PNG Gerolymatos SA
In the US, provides PluroGen access to 25,000 drug stores
- For example Wal Mart, Rite Aid, Walgreens, Pathmark, Harmon Drugs and others - Internet outlets such as Drugstore.com
Provides PluroGen access in key EU countries to the drug store, hospital, animal health and cosmetic markets
Initial scope of the agreement targeted to distribution, joint new product development and regulatory collaboration
Initial products of interest include:
- Medical device wound barrier products based on PluroGel™ Silver Sulfadiazine (topical gels and dressings)
- Medical device wound & skin cleansing products based on PluroGel™ - Regulatory exempt wound covers based on PluroGel™ (topical gels and dressings) - OTC products based on both company’s technologies - Cosmetic products based on PluroGel™ - Animal health products derived from above
PNG Gerolymatos has 4 business segments: Pharmaceutical, OTC, Consumer and Animal Health
PNG Gerolymatos has operations and does business in the US, major countries in Europe and the far East
Welcare placed its 1st commercial order for PluroGel™ concentrate
Welcare introduced 2 medical devices with PluroGel™ at the prestigious European Wound Management Congress
Welcare is a European medical device manufacturer and marketer
Welcare is providing Plurogen entry into a new market: the medical wound and skin cleansing market
Derma Sciences delivered the 2nd set of dressing samples for PluroGen review
PluroGen continues discussion with other potential commercial partners as well
Sales and Marketing
Raised end-user pricing on our 1st product, PluroGel™ Silver Sulfadiazine to USD 75.00 per unit for the 400g jar
As part of our ongoing pricing and product reviews, our most recent survey of new product pricing, burn doctor field interviews and our own new product features support this increase in price
The increase in price has considerable upside impact on our financial projections:
1st 5 years total revenue increases by $ 185 million
1st 5 years total operating profit increases by $ 154 million
Gross margins increase from the high 60%’s to the high 80%’s
Desirability of PluroGen and our products, and therefore our exit value, is increased
Regulatory
Aggressively pursuing medical device regulatory approval for PluroGel™ Silver Sulfadiazine
Completed draft of the US FDA 510(k) for medical device approval
PNG Gerolymatos began EU regulatory work
Identified final testing required for 510(k), in negotiation with contract labs
Welcare performing testing to support their EU medical device approval for our PluroGel™ ingredient
1st test complete with positive results; results will be used to support new sales & marketing claims
2nd set of tests targeted to complete in Q3 08
Registered with FDA to sell FDA-exempt OTC PluroGel™ wound cover products (gels and dressings)
PluroGen is cleared by FDA to sell
Adds the OTC market for Plurogen technology and products
Opened talks for additional products with current partners and new potential partners
Continue to maintain low expense, forward activity for drug approval for PluroGel™ Silver Sulfadiazine
Advance preparation for any future drug claims we determine to pursue
Intellectual Property
Converted and filed the provisional patent to a patent application for our gel’s activity to enhance blood flow
Continue to explore licensing IP/technology rights to Dr. Katz’s adipose (fat derived) stem cells for wound healing
Manufacturing
PluroGel™ Silver Sulfadiazine production equipment received and in setup
Series A funding required to progress build of 1st production run
Initiated search for manufacturing capacity to make PluroGel™ concentrate for Welcare
Passed month 3 testing of long term accelerated stability test of our PluroGel™ Silver Sulfadiazine
Funding
Series A Offering released in this quarter
Received signed subscription agreements for $275, 000 of the $2.0 million to be raised
Currently pursuing both institutional and private capital investors
Contracted Landmark Capital Corporation to help in the Series A fundraising