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 |
December 9, 2009
RE: Company Update: Q3 2009
Dear Investor:
We continued our progress with another quarter of solid milestone achievements on top of our notable
achievements in the prior quarter. Thank you for making this possible.
Most important in Q3 2009, we received the final opinion of approvable from EU regulators for our flagship
burn and wound gel, PluroGel® Silver Sulfadiazine. The clinical and science sections are complete and
accepted as submitted and we are well on our way to market approval and launch in Europe.
Also in Q3 2009, we had 2 products with their first successful human-use experiences. One product was our
PluroGel® Silver Sulfadiazine successfully used in Europe during the quarter. The second product, our base
PluroGel® 52 – 2 Gel, which was formulated with our commercial partner Dalos BioPharma’s proprietary
botanical agent, was successfully used in the U.S. This second use has opened contract negotiation with a
custom pharmacy to compound and market prescription topical products based on our PluroGel®.
Another important milestone in Q3 2009 was an NIH grant award to PluroGen for $100K to study our
PluroGel® gel technology, our Chitosan gel technology along with other technologies in the spray
application of fat-derived stem cells for wound healing.
Moving to fundraising, the environment continues to be extremely challenging. For those who invested
$80K during Q3 2009, our heartfelt thank you. Institutional and traditional sources of funding for early-
stage companies such as PluroGen remain essentially frozen.
Between our focused development programs and tight financial management over the past two years, we
have greatly reduced our aggregate needs for capital. However, additional new investment will continue to
be required over the next four quarters. As always, we would be pleased to follow-up with anyone who
may have an interest in investing.
We look forward to your review and any questions you may have on the 3rd quarter results.
Best regards,
Neal G. Koller
NGK/self
Q3 2009 Company Update
December 9, 2009
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
Regulatory
Intellectual Property
Manufacturing
Funding
RE: Company Update: Q3 2009
Dear Investor:
We continued our progress with another quarter of solid milestone achievements on top of our notable
achievements in the prior quarter. Thank you for making this possible.
Most important in Q3 2009, we received the final opinion of approvable from EU regulators for our flagship
burn and wound gel, PluroGel® Silver Sulfadiazine. The clinical and science sections are complete and
accepted as submitted and we are well on our way to market approval and launch in Europe.
Also in Q3 2009, we had 2 products with their first successful human-use experiences. One product was our
PluroGel® Silver Sulfadiazine successfully used in Europe during the quarter. The second product, our base
PluroGel® 52 – 2 Gel, which was formulated with our commercial partner Dalos BioPharma’s proprietary
botanical agent, was successfully used in the U.S. This second use has opened contract negotiation with a
custom pharmacy to compound and market prescription topical products based on our PluroGel®.
Another important milestone in Q3 2009 was an NIH grant award to PluroGen for $100K to study our
PluroGel® gel technology, our Chitosan gel technology along with other technologies in the spray
application of fat-derived stem cells for wound healing.
Moving to fundraising, the environment continues to be extremely challenging. For those who invested
$80K during Q3 2009, our heartfelt thank you. Institutional and traditional sources of funding for early-
stage companies such as PluroGen remain essentially frozen.
Between our focused development programs and tight financial management over the past two years, we
have greatly reduced our aggregate needs for capital. However, additional new investment will continue to
be required over the next four quarters. As always, we would be pleased to follow-up with anyone who
may have an interest in investing.
We look forward to your review and any questions you may have on the 3rd quarter results.
Best regards,
Neal G. Koller
NGK/self
Q3 2009 Company Update
December 9, 2009
PluroGen Milestones and Accomplishments
Commercial Partnering (Sales, Marketing and Product Development)
- Clinical Use within Europe for PluroGel® Silver Sulfadiazine (PSSD) Product Line
- Kick-off meetings with doctors and distributors at the European Burn Association Congress and
- the European Pressure Ulcer Congress both in September 2009.
- Chronic Wounds
- 1st patient use with good success began in Palma de Mallorca, Spain
- Meeting and planning continue for use in Turin Italy
- Meeting and planning continue for use at University of Zurich, Zurich Switzerland
- Burns
- Discussions and planning continue for use in Turin Italy
- Meeting and planning continue for use at University of Lausanne, Lausanne Switzerland
- Meeting and planning continue for use at University of Zurich, Zurich Switzerland
- Meeting and planning continue for use at Red Cross Hospital, Amsterdam, The
Netherlands
- European distribution of PluroGel® Silver Sulfadiazine (PSSD) Product Line
- Opened discussions for Germany
- Continued negotiation with Welcare for Italy
- Continued negotiation with GD Medical for Switzerland
- Continued negotiation for Austria, Finland, Germany, Netherlands and Spain
- Welcare Industries
- PluroGel®-based skin & wound cleansing medical devices
- Reported year-to-date sales through 6/30/09 for opening distributor orders of € 75.2K
($113.5K) - Negotiation of distribution agreement for the U.S. on going
- Development on-going for a liquid-form medical device using PluroGel® & Welcare technologies
- Testing begun for a gel-form medical device using PluroGel® & Welcare technologies
- Agreement negotiation on going for European distribution of the liquid-form PluroGel® /
Welcare cleanser - Agreement negotiation on going for European distribution of the gel-form PluroGel® / Welcare
Wound Gel
- HemCon Medical Technologies
- Initial test results indicate PluroGel® is compatible with Hemcon nanofiber technology
- Established next testing program to incorporate PluroGel® into nanofibers
- Dalos BioPharma
- Successful 1st human use of PluoGel® based product incorporating Dalos’ proprietary botanical
agent
- Compounding Rx Apothecary
- Negotiations begun to compound and market PluroGel® based topical custom prescription
topical products
- Derma Sciences wound dressing program
- Work pending Derma Science internal funding
- 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
Regulatory
- PluroGel® Silver Sulfadiazine product line - medical device regulatory approval
- Europe
- Final opinion by European Health Authority is “approvable” as a medical device
- Continued preparation for EU on-site inspections of quality & manufacturing
- U.S.
- Continue to engage with FDA on approvability as medical device or drug
- Continue to maintain low expense, forward activity for drug approval for PluroGel® Silver
Sulfadiazine
- Welcare’s PluroGel® based skin & wound cleansing products – testing for US FDA 510(k) initiated
- Personal Skin Care Products
- Continue focus on products not requiring FDA filing with work on cosmetic & exempt medical
device claims
Intellectual Property
- Made the international filings (PCT Nationalization stage) for our PluroGel® Biofilm patent application
- Continue to explore licensing IP/technology rights to Dr. Katz’s adipose (fat derived) stem cells for
wound healing
Manufacturing
- Initiated batch manufacture and process finalization for base PluroGel® 52 – 2 Gel
- Initiated drafting of EU multi-lingual labeling for base PluroGel® 52 – 2 Gel
- Continued preparation for EU regulatory site inspection for PluroGel® Silver Sulfadiazine
- Continued revisions of draft of Quality Manual
Funding
- Raised $80,000 in this quarter
- To date, $705, 000 raised in the Series A
- Continue to pursue institutional and private investors to complete the Series A raise