Neal G. Koller
President & Chief Executive Officer
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 |
February 25, 2009
RE: Company Update: Q4 2008
Dear Investor:
The 4th quarter of 2008 continued the significant progress we achieved throughout the year. As you already know, this
quarter has most likely presented the toughest fund raising and business environment ever – certainly in our lifetime.
However, we have taken appropriate steps, finding ways to bring products to market faster and at lower cost. Although
times are tough, we have significantly lowered our investment capital requirement and increased our commercial
opportunities. While our resources have been limited, we are positioned to continue to make great forward progress. It
is more critical than ever to uncover and attract new sources of investment capital as traditional sources have frozen.
Each additional investment will hasten our success and we would be happy to follow-up with anyone who may have an
interest in investing. Even in this difficult investment environment, PluroGen is poised to provide a terrific return.
We hope this update is informative, but please feel free to contact us if you have any questions. We are grateful, and
thank you, for your interest as well as your investment.
Q4 2008 Update
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
- Next sample sets needed for other chronic wound dressings and burn dressings
Regulatory
Intellectual Property
Manufacturing
Funding
Best Regards,
Neal Koller
President and CEO
PluroGen Therapeutics
RE: Company Update: Q4 2008
Dear Investor:
The 4th quarter of 2008 continued the significant progress we achieved throughout the year. As you already know, this
quarter has most likely presented the toughest fund raising and business environment ever – certainly in our lifetime.
However, we have taken appropriate steps, finding ways to bring products to market faster and at lower cost. Although
times are tough, we have significantly lowered our investment capital requirement and increased our commercial
opportunities. While our resources have been limited, we are positioned to continue to make great forward progress. It
is more critical than ever to uncover and attract new sources of investment capital as traditional sources have frozen.
Each additional investment will hasten our success and we would be happy to follow-up with anyone who may have an
interest in investing. Even in this difficult investment environment, PluroGen is poised to provide a terrific return.
We hope this update is informative, but please feel free to contact us if you have any questions. We are grateful, and
thank you, for your interest as well as your investment.
Q4 2008 Update
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
- Welcare (First Distribution Agreement signed Q1 2008)
- PluroGen shipped Welcare its 2nd order for the skin and wound cleansing medical device products
- Initiated exploration of the US market for skin and wound cleansing medical device products
- Continued negotiation of distribution agreement for Italy for PluroGel™ Silver Sulfadiazine Product Line
- GWR Medical
- Signed US distribution agreement for PluroGel™ Silver Sulfadiazine Product Line
- “Personal Skin Care Company” (selling products through their network of 1,250 retail stores)
- Signed Letter of Intent & initiated new product development work on a possible 6 different products
- Derma Sciences
- 3rd sample set evaluated, 4th sample set due Q1 2009
- Next sample sets needed for other chronic wound dressings and burn dressings
- HemCon Medical Technologies
- Signed agreement to explore co-product development
- Syndegen, Inc.
- Signed agreement to explore co-product development
- MediWound
- Entered negotiations to explore co-product development
- Dalos BioPharma
- Entered negotiations to explore co-product development
- PNG Gerolymatos SA, (Letter of Intent Signed Q2 2008)
- Activity on hold as Gerolymatos is being acquired
Regulatory
- Aggressively pursuing medical device regulatory approval for PluroGel™ Silver Sulfadiazine product line
- For the Gel products, initiated final laboratory tests required for FDA 510(k) medical device submission
- For the Dressing Products, began exploration of test requirements for FDA 510(k) medical device
submission
- Welcare medical device approval for products with our PluroGel™ as an ingredient
- EU medical device approval in progress
- Initiated exploration of US FDA medical device approval
- Personal Skin Care Products
- Began focus on products not requiring FDA filing, initiated development of cosmetic & medical device
claims
- Continue to maintain low expense, forward activity for drug approval for PluroGel™ Silver Sulfadiazine Gel
- Advance preparation for any future drug claims we determine to pursue
Intellectual Property
- Converted our core gel technology manufacturing provisional patent to a patent application
- Continue to explore licensing IP/technology rights to Dr. Katz’s adipose (fat derived) stem cells for wound healing
Manufacturing
- Continued revisions of draft of Quality Manual
- Manufactured 2nd lot of PluroGel™ 45 – 5 Concentrate for Welcare
- Manufactured multiple samples for the “Personal Skin Care Company”
- Entered negotiations with Fox Pharmaceuticals for small and medium volume production
- Entered negotiations for small and medium volume production equipment
Funding
- Received commitments for an additional $75, 000 for the Series A Offering
- To date, $350, 000 of the $2.0 million has been raised in the Series A
- Continue to pursue institutional and private investors
- Selected to present at Angel Capital Association Southeast Conference in Savannah GA (only 8 Co’s in total
selected)
Best Regards,
Neal Koller
President and CEO
PluroGen Therapeutics