Risks Specific to BioClonetics Immunotherapeutics
The next 3 steps in our development of our anti-HIV monoclonal antibody (Clone 3) are to
(1) create the recombinant of the Clone 3 antibody in a CHO cell line and produce a sufficient quantity of the recombinant for testing,
(2) test the recombinant Clone 3 against a full panel of HIV isolates (strains of the virus) and thereafter
(3) conduct macaque animal trials to demonstrate the effectiveness of the antibody in an animal study.
In these steps, possible difficulties can arise such as: difficult or delay in creating a successful CHO cell line; the created cell line only being transient and not a stable permanent CHO cell line; the cell line secreting non-biologically active recombinant antibody; or the CHO cell line not secreting a sufficient quality or quantity of antibody. Once the recombinant cell line is produced, the resultant antibody may not demonstrate the same effectiveness against HIV isolates tested as has the parent cell line produced monoclonal antibody. In the macaque trials, the results may not be full validation of the neutralizing capability of the Clone 3 antibody previously demonstrated as fully neutralizing in in vitro tests.
Though most of the officers are full time, the following officers are part time: Gaurav Chandra, M.D., FAGE, MBA, Vice President of Research and Development, and Seth Sheiner, M.D., MSIS, CPHIMS, Vice President of Project Management and Data Analysis.
3. While it is unlikely, patent protection that we expect to secure may be limited or may not prevent another company from circumventing our technology. If this were to occur, then a competitor may produce a similar therapy that prevents the successful adoption and sale of ourmonoclonal antibody. In this event, our profit potential would be adversely effected.
4. Our technology might not be as effective as other monoclonals developed in the future. If this were to occur, then our monoclonal would be competing with more effective therapies and would be less likely to produce revenue.
5. The cost to complete human trials will be large and we will need to partner with pharmaceutical companies to complete such trials. Difficulty could arise in these negotiations. If there were to occur, the pharmaceutical bidders might place a low valuation on our technology on the basis that further human trials and bring-to-market costs are so great.
6. Human trials might not produce the favorable results we expect. If this were to occur, our monoclonal would not likely be accepted in the market place as a viable therapy.
7. Other therapies might compete with our approach and limit the financial return. There might be several alternatives to our therapy and thus this would limit our profit potential or the valuation of our technology. However, a combination of therapies is often used in patient treatment for most all diseases.
8. As a biotech company that relies on specialized outside labs to conduct some phases of our development work, their actions and/or unauthorized use of proprietary technology or patented components might affect the resulting products produced under contract for us. If this were to occur, then our final product may be subject to a claim of rights by other parties with whom we have no direct contact.
9. Our reliance on outside specialized labs also could result in delays in advancement due to problems occurring in these labs over which we have no control. Such situations could delay our development significantly or might prevent successful progress altogether.
10. Because we use multiple specialized outside labs to confirm final efficacy, contradictory results can result, causing delays and uncertainty regarding the optimum final product.
11. Officer Charles S. Cotropia, Gaurav Chandra, and Seth Sheiner are not currently full time with the company. As such, it is likely that the company will not make the same progress as it would if that were not the case.