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 |
May 29, 2009
Company Update: Q1 2009
Despite the global economic slump, PluroGen hit a number of important milestones and achieved solid progress in the
1st quarter of 2009. Unfortunately, the environments for business, in general, and fund raising, in particular, continue to
be difficult and we do not foresee much change over for the next several quarters. In spite of that, however, PluroGen
is experiencing success with its strategy and tactics to bring products to market faster and at lower cost keeping with
our plan of significantly lower investment capital requirement and increased commercial opportunity. Resources
continue to be limited but we are positioned, as you will read below, to continue making important forward progress.
Traditional sources of capital remain frozen. Attracting new sources of investment remains a primary concern and
effort. A good number of venture capital sources and early stage businesses have simply folded over the last several
quarters. Within that environment, you will see PluroGen made progress in Q1 09 in fundraising - a real confirmation of
support and value in our business plan and opportunity for return on investment. More investment is needed. As
always, we are 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.
Q1 2009 Company Update
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
Regulatory
Intellectual Property
Manufacturing
Funding
We hope you are as pleased with our 1st Quarter Company Update as we are. Feel free to contact us if you have any
questions. We are grateful for your support and thank you for your interest – in addition to your investment.
Best Regards,
Neal G. Koller
President & CEO
PluroGen Therapeutics, Inc.
Company Update: Q1 2009
Despite the global economic slump, PluroGen hit a number of important milestones and achieved solid progress in the
1st quarter of 2009. Unfortunately, the environments for business, in general, and fund raising, in particular, continue to
be difficult and we do not foresee much change over for the next several quarters. In spite of that, however, PluroGen
is experiencing success with its strategy and tactics to bring products to market faster and at lower cost keeping with
our plan of significantly lower investment capital requirement and increased commercial opportunity. Resources
continue to be limited but we are positioned, as you will read below, to continue making important forward progress.
Traditional sources of capital remain frozen. Attracting new sources of investment remains a primary concern and
effort. A good number of venture capital sources and early stage businesses have simply folded over the last several
quarters. Within that environment, you will see PluroGen made progress in Q1 09 in fundraising - a real confirmation of
support and value in our business plan and opportunity for return on investment. More investment is needed. As
always, we are 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.
Q1 2009 Company Update
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
- Welcare
- Launched sales of PluroGel-based skin & wound cleansing medical devices into Germany, Italy,
Switzerland - Signed Letter of Intent to enter US market for PluroGel-based skin & wound cleansing medical devices
- Continued negotiation of distribution agreement for Italy for PluroGel™ Silver Sulfadiazine Product Line
- Initiated 180 patient clinical trial for PluroGel™ based UCS product in chronic wound patients
- Purchased exhibit booth at primary European Wound Congress, May 2009, for PluroGel™ based products
- Derma Sciences - 3rd sample set evaluated, 4th sample set due Q2 2009
- Drafted sampling & testing program for medical device regulatory submission (510[k])
- Ordered next sample set of chronic wound dressing for 510[k] testing
- Ordered next sample set of burn dressing for user preference evaluation
- HemCon Medical Technologies
- Shipped samples of PluroGel solid to HemCon for technology compatibility testing
- Dalos BioPharma
- Signed Letter of Intent to explore co-product development of both companies proprietary technologies
- MediWound
- Signed Letter of Intent to explore co-product development
- “Personal Skin Care Company” (selling products through their network of 1,250 retail stores)
- Competed 1st formulation, initiated 2nd formulation for 1st 3 products (wound gel, skin balm & lib balm)
- Initiated 1st formulation for next 3 products (facial cleanser, body wash, OTC topical antibiotic)
- PNG Gerolymatos SA, (Letter of Intent Signed Q2 2008)
- Activity on hold as Gerolymatos is being acquired
- GWR Medical
- Continue relationship development ahead of US approval of PluroGel™ Silver Sulfadiazine Gel (PSSD)
- Syndegen, Inc.
- Awaiting Syndegen internal funding for product exploration of both companies proprietary technologies
Regulatory
- Medical device regulatory approval for PSSD product line
- For PSSD Gel, received last of the test reports needed to complete the FDA submission; final drafting in
process - For PSSD Gel, initiated drafting of EU CE Dossier
- For PSSD Dressing Products, drafted test requirements for FDA 510(k) medical device submission
- Welcare medical device approval for PluroGel-based skin & wound cleansing products
- EU medical device approval received
- Initiated drafting of US FDA medical device submissions for 2 products
- 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
- Initiated PluroGel™ trademark application for International markets (already filed for the US)
- Initiated ActiviGel™ trademark application for the US
- Continue to explore licensing IP/technology rights to Dr. Katz’s adipose (fat derived) stem cells for wound
healing
Manufacturing
- Signed agreement with Fox Pharmaceuticals for small and medium volume production
- Purchased small and medium volume production equipment
- Initiated manufacture of 3rd lot of PluroGel™ 45 – 5 Concentrate for Welcare
- Manufactured multiple samples for the “Personal Skin Care Company”
- Continued revisions of draft of Quality Manual
Funding
- Raised $325,000 in this quarter
- To date, $575, 000 raised in the Series A
- Continue to pursue institutional and private investors
- Selected to present at AAI Breakfast Club in Washington DC
We hope you are as pleased with our 1st Quarter Company Update as we are. Feel free to contact us if you have any
questions. We are grateful for your support and thank you for your interest – in addition to your investment.
Best Regards,
Neal G. Koller
President & CEO
PluroGen Therapeutics, Inc.