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 |
September 18, 2009
Dear Investor
I am pleased to report that PluroGen had a milestone busting quarter and I want to reiterate my thanks for
making it possible. Your support and investment has enabled the company to progress from a raw start-up
company in development to one on the cusp of market introductions.
Within the enclosed Q2 09 quarterly report, you will note major achievements ranging from the filing of the
medical device marketing applications for our flagship burn and wound gel, PluroGel® Silver Sulfadiazine, for
both Europe and the US to continued progress in our commercial partnering endeavors.
Our European submission received a preliminary opinion of “approvable” from the European regulatory
authority. This means the clinical and scientific sections of our submission, on preliminary review, are
essentially complete and we will move through approval, manufacturing inspection and to market launch.
While we are pleased with our efforts toward product introduction, we continue to be frustrated by
conditions on the financing front. Unfortunately, the environments for business and in particular fund
raising, continue to be difficult. We are told that institutional funding for early-stage entities has essentially
dried up and no one projects this will change for the next several quarters. In the absence of traditional
sources of venture capital, early stage businesses continue to fold.
Though we have reduced considerably our total capital requirement for the burn and wound gel to reach
market, fresh capital is needed in the near term for a successful market launch. Attracting new investment
remains a priority and effort. As always, we are happy to follow-up with anyone who may have an interest
in investing.
If you have any questions on our 2nd quarter results, please feel free to contact us.
Q2 2009 Company Update
September 18, 2009
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
Regulatory
Intellectual Property
Manufacturing
Funding
Best Regards,
Neal Koller
President and CEO
PluroGen Therapeutics
Dear Investor
I am pleased to report that PluroGen had a milestone busting quarter and I want to reiterate my thanks for
making it possible. Your support and investment has enabled the company to progress from a raw start-up
company in development to one on the cusp of market introductions.
Within the enclosed Q2 09 quarterly report, you will note major achievements ranging from the filing of the
medical device marketing applications for our flagship burn and wound gel, PluroGel® Silver Sulfadiazine, for
both Europe and the US to continued progress in our commercial partnering endeavors.
Our European submission received a preliminary opinion of “approvable” from the European regulatory
authority. This means the clinical and scientific sections of our submission, on preliminary review, are
essentially complete and we will move through approval, manufacturing inspection and to market launch.
While we are pleased with our efforts toward product introduction, we continue to be frustrated by
conditions on the financing front. Unfortunately, the environments for business and in particular fund
raising, continue to be difficult. We are told that institutional funding for early-stage entities has essentially
dried up and no one projects this will change for the next several quarters. In the absence of traditional
sources of venture capital, early stage businesses continue to fold.
Though we have reduced considerably our total capital requirement for the burn and wound gel to reach
market, fresh capital is needed in the near term for a successful market launch. Attracting new investment
remains a priority and effort. As always, we are happy to follow-up with anyone who may have an interest
in investing.
If you have any questions on our 2nd quarter results, please feel free to contact us.
Q2 2009 Company Update
September 18, 2009
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
- Clinical Use within Europe for PluroGel® Silver Sulfadiazine (PSSD) Product Line
- Burns
- -Initiated discussions for use in Turin Italy
-Initiated discussions for use at University of Lausanne, Lausanne Switzerland
-Initiated discussions for use at University of Zurich, Zurich Switzerland
-Initiated discussions for use at Red Cross Hospital, Amsterdam, The Netherlands
- Chronic Wounds
- -Initiated discussions for use in Turin Italy
-Initiated discussions for use at University of Zurich, Zurich Switzerland
- Plastic Surgery
- -Initiated discussions for use in Palma de Mallorca & Madrid, Spain
-Initiated discussions for use in Genoa, Italy
- European distribution of PluroGel® Silver Sulfadiazine (PSSD) Product Line
- Continued negotiation with Welcare for Italy
- Opened discussions with GD Medical for Switzerland
- Began discussions for Austria, Finland, Germany, Netherlands and Spain
- Welcare Industries
- PluroGel®-based skin & wound cleansing medical devices
- -Welcare selling the PluroGel®-based products in Finland, Germany, Italy and Switzerland
-Initiated negotiation of distribution agreement for the US
-180 patient multi-center clinical trial presented at EWMA (European Wound Congress) in
Helsinki
- Clinical trial results very positive and are posted on the PluroGen website
- Initiated development for a liquid medical device using PluroGel® & Welcare skin & wound
cleansing liquid - Initiated development for a gel medical device using PluroGel® & Welcare skin & wound
cleansing liquid - Initiated negotiation of distribution agreement for Europe for the liquid PluroGel® / Welcare
cleansing product - Initiated negotiation of distribution agreement for Europe for the PluroGel® / Welcare Wound
Gel
- Derma Sciences - 3rd sample set evaluated, 4th sample set due Q4 2009
- Sampling & testing plan accepted for PluroGel® Silver Sulfadiazine (PSSD) Dressing
- -Test results to be used for US and European regulatory submissions
-Building PSSD product for next sample set of chronic wound dressing for 510(k) testing
- Sampling plan developed for a PluroGel® dressing based on Dalos’ biological active
- Sampling plan developed for a PluroGel® dressing based on PluroGel® & Welcare skin & wound
cleansing gel
- HemCon Medical Technologies
- Initial test results indicate PluroGel® is compatible with Hemcon technology
- Established next testing program
- Dalos BioPharma
- Formulated several PluroGel® wound gels based on Dalos biological active, Flavokine
- Formulated several PluroGel® facial cleansers based on Dalos Flavokine
- Dalos preparing user preference testing
- MediWound
- Work pending MediWound project funding
- “Personal Skin Care Company”
- Low level work on 2nd formulations
- Pending Personal Skin Care Company funding
- PNG Gerolymatos SA
- Activity on hold as Gerolymatos is being acquired
- Syndegen, Inc.
- Awaiting Syndegen internal funding for product exploration of both companies proprietary
technologies
- GWR Medical
- Continue relationship development ahead of US approval of PluroGel™ Silver Sulfadiazine Gel
(PSSD)
Regulatory
- PluroGel® Silver Sulfadiazine (PSSD) product line - medical device regulatory approval
- Submitted PSSD Gel European CE Dossier
- -Preliminary review by European Health Authority is “approvable” as a medical device
-Began preparation for EU on site inspection of quality & manufacturing
- Submitted PSSD Gel FDA 510(k)
- -Continue to engage with FDA on approvability as medical device or drug
- Welcare’s PluroGel®-based skin & wound cleansing products - US FDA 510(k)’s 1st drafts complete
- Personal Skin Care Products
- Continue focus on products not requiring FDA filing with work on cosmetic & exempt medical
device claims
- Continue to maintain low expense, forward activity for drug approval for PSSD
Intellectual Property
- Filed our 4th patent on our core PluroGel® technology
- Received the US registration approval for the PluroGel® trademark allowing us to move from the “™”
to the “®”
- Filed EU registration approval for the PluroGel trademark
- Continue to explore licensing IP/technology rights to Dr. Katz’s adipose (fat derived) stem cells for
wound healing
Manufacturing
- Began preparation for EU regulatory site inspection
- Installed and began testing production equipment for PSSD Gel
- Completed manufacture of 4th lot of PluroGel® 45 – 5 Concentrate for Welcare
- Manufactured multiple samples for the “Personal Skin Care Company”
- Manufactured multiple samples for the Dalos BioPharma
- Continued revisions of draft of Quality Manual
Funding
- To date, $625, 000 raised in the Series A
- Continue to pursue institutional and private investors to finish the Series A raise
Best Regards,
Neal Koller
President and CEO
PluroGen Therapeutics