Securities and Exchange Commission
Washington, DC 20549
Form 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) December 16, 2002
ASTRALIS LTD.
(Exact Name of Registrant as Specified in its Charter)
Delaware 000-30997 84-1508866
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(State or Other (Commission File Number) (IRS Employer
Jurisdiction of Incorporation) Identification No.)
75 Passaic Avenue, Fairfield, New Jersey 07004
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (973) 227-7168
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(Former Name or Former Address, if Changed Since Last Report)
ITEM 9. REGULATION FD DISCLOSURE.
On December 16, 2002, the registrant mailed to its shareholders a brochure
containing the following information:
About Astralis
Astralis Ltd, an emerging biotechnology company based in New Jersey, focuses on
the research and development of novel treatments for immune system disorders and
skin diseases. Astralis has developed a viable technology platform, enabling the
further development of PSORAXINE(TM) as well as other promising therapeutics.
Versatile Research & Development Platform
"Astralis is now better positioned to develop its research in other therapeutic
areas from our new U. S. based facility using the technology platform developed
in Venezuela over the last 15 years" commented Mike Ajnsztajn, Astralis' Chief
Executive Officer.
180 million people around the world suffer from Psoriasis - National Psoriasis
Foundation
Psoraxine(TM) (AS 210)
Psoraxine(TM), the company's first product candidate, is an innovative drug
under development for the treatment of psoriasis, and is based on the company's
discovery of a new gene sequence of proteins. To date, clinical trial data
suggests remission of psoriasis in approximately 3000 patients in Venezuela.
Characteristics of Psoraxine(TM)
Psoraxine(TM) is believed to induce a cellular response. Preliminary studies
have indicated that there is no antibody creation, no immunosuppression, no
programmed cell death, and no killing of T-cells.
Corporate Information
OTC Bulletin Board: ASTR
Internet Address
www.astralisltd.com
Recent Share Price
(2 December 2002)
US $0.65
Shares Outstanding
(2 December 2002)
37.5 million Common Shares
Market Capitalization
(2 December 2002)
$24.4 Million
52-week Trading Range
$0.22 - $3.35
Board of Directors
Jose Antonio O'Daly, MD, PhD,
Chairman of the Board and President of R&D
Mike Ajnsztajn
Chief Executive Officer
Gina Tedesco
Chief Financial Officer
Gaston Liebhaber
Director of International Affairs
Michael Ashton
CEO SkyePharma
Fabien Pictet
CEO Fabien Pictet & Partners Global Holdings
Steve Fulda
Fairleigh Dickenson University
Advisory Board
Medical Advisor
Dr. James Leyden
Professor
Department of Dermatology
University of Pennsylvania Hospital
Marketing Advisor
Bruce Epstein
President Noesis Healthcare
Contact Information:
Gina Tedesco,
Chief Financial Officer / Head of IR
75 Passaic Avenue, Fairfield, N.J. 07004 U.S.A.
Tel: 1 973 227 7168
Fax: 1 973 227 7169
Email: info@astralisltd.com
Technology Transfer Update
The transfer of the technology platform and manufacturing process to the New
Jersey R&D facility was finalized in August 2002. The Psoraxine(TM) preliminary
production process has been standardized, and continuous production has been
established for clinical supplies.
Psoraxine(TM) manufacturing upscaling is currently under development.
Strong R&D Base
With approximately $500K of capital investment in the R&D facility, Astralis has
built a strong base on which to continue research in other therapeutic areas.
Summary of Financial Information
Astralis Ltd
(A Development Stage Entity)
Selected Statement of Operation Information (Unaudited)
January 1st, 2002 to September 30th, 2002
Revenues --
Total Operating Expenses $ 8,347,189
Loss from Operations $(8,347,189)
Other Income - Interest Income $ 94,889
Net Loss to Common Stockholder $(8,522,300)
Basic and diluted loss per common share $ (0.23)
Recent Highlights
November 2002
Continuing Pre-IND discussions with the FDA
October 2002
Manufacturing process standardized for U.S. clinical supply production for Phase
I and Phase II clinical trials. Implemented preliminary Standard Operating
Procedures and Good Manufacturing Practices
August 2002
Completed Transfer of Technology from Venezuela to Fairfield, New Jersey R&D
Facility
July 2002
SkyePharma purchases an additional $2.5 million of preferred shares bringing the
total capital injected to $17.5 million dollars, $10 million in Dec 2001, $2.5
million in Jan 2002, $2.5 million in April 2002, $2.5 million in July 2002.
June 2002
Initiated transfer of Venezuelan R&D Team to Fairfield, New Jersey R&D Facility.
The Petition to Make Special for the Psoraxine(TM) Patent was granted by the
United States Patent and Trademark Office, expediting the process
May 2002
Completed Capital Investment of approximately $500K for clean room technology
and state of the art equipment for continued R&D into other therapeutic areas
April 2002
Astralis Ltd US Corporate Headquarters transferred to Fairfield, New Jersey
February 2002
Patent application filed under Patent Cooperation Treaty (PCT) for international
protection
December 2001
Purchase Agreement signed with SkyePharma to purchase up to $20 million in
convertible preferred shares. Service Agreement with SkyePharma agreed upon to
provide development, pre-clinical and clinical development services. Technology
Transfer Agreement with SkyePharma for access to drug delivery technology
November 2001
Raised an initial round of funding via a private placement of $3.2 million in
conjunction with a merger into a public shell company to form Astralis Ltd.
May 2001
Pre Investigational New Drug Application (IND) meeting with the FDA to discuss
United States IND filing
March 2001
Astralis filed patent with United States Patent and Trademark office for first
product candidate, Psoraxine
March 2001
Astralis LLC founded in the US based on 15 years of work in Venezuela by Dr.
Jose Antonio O'Daly
Information or opinions in this fact sheet are presented solely for informative
purposes and are not intended nor should be construed as investment advice.
Astralis may carry a high investment risk. We encourage you to carefully review
the company with your investment advisor and that you verify any information
that is important to your investment decision. This fact sheet may contain
forward-looking statements regarding Astralis Ltd. Actual results may differ
materially from those described in the fact sheet as a result of a number of
factors, including but not limited to the following: There can be no assurance
that PSORAXINE(TM) will be successfully developed or manufactured, or that final
results of human clinical trials will result in the regulatory approvals
required to market products, or that final regulatory approval will be received
in a timely manner, if at all, or that patient and physician acceptance of this
product will be achieved. Astralis will continue its research and development
effort to the extent that we do not experience any cash shortfalls, adverse
developments in our drug development or competitive or other impediments that an
early stage company in our industry may face. Astralis Ltd undertakes no
obligation to revise or update any such forward-looking statement to reflect
events or circumstances after the date of this fact sheet.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ASTRALIS LTD.
Date: December 16, 2002 By: /s/ Mike Ajnsztajn
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Mike Ajnsztajn
Chief Executive Officer