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 |
March 25, 2007
Dear Investor:
We would like to take this opportunity to provide you a Q1 '07 update for PluroGen. Since our last update from 12 '06,
the Company has realized success on multiple fronts. Two new key developments include:
Our intention is to create near-term revenue sources to help advance our longer-term product pipeline. We are currently
raising a Series A financing to support our clinical and R&D programs. We would be very interested in speaking with
you about the opportunity we are developing at PluroGen.
Q1 '07 Update:
Regulatory & Clinical
Manufacturing
Funding
Other
Neal G. Koller
NGK/sa
Dear Investor:
We would like to take this opportunity to provide you a Q1 '07 update for PluroGen. Since our last update from 12 '06,
the Company has realized success on multiple fronts. Two new key developments include:
- FDA agreement that we can proceed to Phase III Human Studies for our first generation burn & wound care
product - Development of novel Intellectual Property (IP) for treatment of wound related infection and 2nd generation
products
Our intention is to create near-term revenue sources to help advance our longer-term product pipeline. We are currently
raising a Series A financing to support our clinical and R&D programs. We would be very interested in speaking with
you about the opportunity we are developing at PluroGen.
Q1 '07 Update:
Regulatory & Clinical
- Satisfied with the non-clinical data on the performance of the first generation wound care product, in our
meeting with FDA the agency suggested, unusually and beneficially for PluroGen, that PluroGen submit our
clinical trial synopsis ahead of our IND, which we did in February; indicating FDA may also have an appreciation
for the patient value of our technology - Initiated work to begin regulatory approval in Europe
- Established the multi-center clinical trial sites under the direction of lead investigators and physicians at the
principal burn and wound care hospitals in the US:
- - Richard Kagan, MD, Current President American Burn Association (ABA)
Shriners Hospital for Children, Cincinnati, Ohio
University Hospital Burn Center, Cincinnati, Ohio
- David Greenhalgh, MD, Past President ABA
Shriners Hospital for Children, Northern California, Sacramento, Calf.
UC Davis Regional Burn Center, Sacramento, California
- David Heimbach, MD, Past President ABA & International Society of Burn Injury (ISBI)
University of Washington Burn Center, Seattle, Washington
Richard L. Gamelli, MD, Past President ABA, Editor Journal of Burn Care
Loyola University Medical Center, Maywood, Illinois
- John Hunt, MD, Past President ABA
Parkland Memorial hospital, Regional Burn Center, Dallas Texas
- Steve Wolf, MD
US Army Institute of Surgical Research, Fort Sam Houston, Texas
- Marion H. Jordan, MD, Past President ABA
District of Washington Hospital Burn Center, District of Columbia
- Daniel Caruso, MD
Arizona Burn Center, Maricopa Medical Center, Phoenix Arizona
- Filed PluroGen provisional patent application to strengthen IP for first generation product platform and next
generation products and technology - Preparing two new PluroGen patent applications for novel therapeutic technology to fight wound infections
- Initiated license negotiations with the University and friendly parties for follow-on developments associated with
the core technology as well as next generation therapeutic products - Renegotiated favorable business terms for original University licensed technology
Manufacturing
- Contracted with DPT Labs, leading contract topical drug manufacturer in the US, for formulation and scale-up
development; shelf-life analysis
Funding
- Closed 1st funding round on 1/31/07 ahead of targeted investment amount
- - Cato BioVentures increased its investment
- The Virginia Active Angel Network completed its due diligence and made an investment
- Another Angel Network completed due diligence with investment, based upon first angel round terms
expected within 60 days
- Initiated active Series A fund raising in February
- - Target $7MM round to support clinical program and product pipeline development
- Initiate discussions for DOD financing of specified product development program
Other
- In late September we were a presenter at the Bio Mid America conference
- In October we were a presenter at the Bio Mid Atlantic conference
- In late January we were the expert guest on one of Washington DC’s premier business radio shows, Tomorrow’s
Business Today
Neal G. Koller
NGK/sa