December 29, 2004
Dear Shareholders:
As 2004 comes to a close it is my pleasure to report on the significant milestones that we at CytoGenix have achieved throughout this highly productive year. The Company has made great progress in both its basic research and product development programs. We have increased the protection of our intellectual property through the filing of four new patent applications addressing anti-viral and anti-bacterial compounds as well as our revolutionary large scale manufacturing process for high purity plasmid DNA. The following is a brief review of our accomplishments in this past year.
CytoGenix, Inc:
Invents Revolutionary Large-Scale Manufacturing Process for High-Purity DNA (Tuesday December 14)
Our DNA production process does not utilize bacterial fermentation to produce plasmid DNA and is therefore free of the toxins and impurities associated with the bacterial process. This gives us the ability to supply our own clinical needs as well as the ever growing market for plasmid DNA in DNA vaccines, cancer treatments and gene silencing. Our ability to produce purer and cheaper plasmid DNA rapidly opens another important market opportunity for the Company.
Initiates Pre-IND Contact with FDA for Clinical Trials of CY301 for Treatment of HSV (Thursday November 4)
We successfully completed pre-clinical anti-herpes safety studies, bringing us closer to obtaining FDA authorization to conduct clinical trials of Simplivir®, our anti-herpes cream. This process will continue with the pre-IND teleconference scheduled with the FDA in January, 2005.
Files U.S. Patent Application for New Class of Antibacterial Agent
(Thursday September 30)
The breadth in our gene silencing technology platform continues to expand and we have developed several additional products against infectious diseases in pre-clinical development. These are under test now as indicated by the next items.
Finds Antimicrobial Compound is Active Against the Most Resistant Bacteria Strain
(Tuesday October 26)
2004 also saw our successful completion of second round pre-clinical, anti-sepsis, animal studies. Our pre-clinical experiments produced unequivocal results and we continued our preparation for submission of an IND application to the FDA.
Announces Results of Anti-Sepsis Pre-Clinical Animal Trials
(Tuesday March 2)
These proof-of-concept studies show that the company's lead DNA anti-bacterial compound was highly effective in controlling bacterial growth and subsequent sepsis in animals. Traditional antibiotic therapy has become increasingly ineffective because bacteria have mutated and developed resistance against antibiotic agents. The Company's gene silencing approach will be more selective in treatment, produce fewer side effects and make it much more difficult for bacteria to develop resistance, if at all.
Announces a Pre-Clinical Research Agreement with Baylor College of Medicine to Test an Agent Against Deadly Resistant Bacteria
(Thursday October 21)
Results obtained from these studies will lead to opportunities for the Company to participate in the 32 Billion Dollar annual antibiotic market.
Awarded National Cancer Institute Research Grant for Pre-Clinical Animal Trials of Aerosol Delivered Gene Silencing Agent Against Lung Tumors
(Wednesday March 10)
This grant combines three major steps for the Company. It is being performed in cooperation with researchers investigating metastatic lung cancer using aerosol delivery. The grant provides yet another validation of the Company's technology by independent peer review, and the grant reinforces our efforts to diversify our funding sources through grants, contracts and licenses. Successful aerosol delivery to the lung or nasal passages opens up a whole new range of possible therapeutic products.
The Company continues to grow.
Due to the promise of our technology we have attracted three additional, outstanding professionals. Kurt Berens, a former NASA project director is leading the product development effort. Prior to his work at NASA, Berens was Senior Project Manager for Clinical Development and Regulatory Affairs at Texas Biotechnology Corp. of Houston, Texas where he was responsible for managing successful clinical trials. Dr. Frederic Kendirgi whose broad experience in developing Virology and Immunology assays for protein function and expression vectors fits well into our focused discovery efforts providing us a continuous flow of new products to complement our two lead candidates. Dr. Kendirgi has participated in the development of the plasmid DNA synthesis process. Dr. Cindee Ewell is a Ph.D. molecular biologist and an attorney who specializes in biotechnology patents. Dr. Ewell will work with our scientists and outside patent counsel to translate laboratory results into patent applications.
2005 will be a breakout year.
The Company's research and development projects will result in clinically testable products. We have already discussed the anti-herpes and anti-microbial products above. We will complete our studies on our anti-inflammatory product, CY302, and submit the pre-IND briefing document to the FDA. Thus, we expect to have two and perhaps, three products in clinical trials next year.
With our expanded scientific team in place we expect to file six to eight new patent applications in the coming year and expand our international coverage adding to our growing patent portfolio.
The plasmid DNA production will provide both a needed resource for our own clinical trials and a potential source of revenue. We are in preliminary discussions with three pharmaceutical companies about this technology. In this connection, we plan to undertake a major research program for DNA vaccines.
The combination of clinical tests and revenue from DNA production will strengthen the company and increase its value. The Company's strength and stability have attracted increasing interest by the financial community in providing support for the Company's continued growth.
We at CytoGenix thank you for your belief, confidence and trust. We are committed to advancing our science to create both human benefit and value for our shareholders. Many of you are in direct communication with us, expressing views and comments on the status of the Company. Such an active approach is very much appreciated. We look forward to reporting additional significant milestones as we strive to fulfill critical unmet medical needs in the months and years to come.
SAFE HARBOR: Except for statements of historical fact, the statements in this press release are forward-looking. Such statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include, but are not limited to, general economic conditions, risks associated with the acceptance of new products, competition, and other factors more fully detailed in the company's filings with the Securities and Exchange Commission. Additional information about CytoGenix and its technology can be found on the website at www.cytogenix.com.
Please accept our best wishes for a happy and healthy new year.
Very truly yours,
Malcolm Skolnick
President/CEO
Contact: Communications Director — Juan Ferreira, (407) 774-9949
