LEXON INC/OK (LXXN.OB)
Quarterly Report (SEC form 10QSB)
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements included in this report which are not historical facts are forward looking statements, including the information provided with respect to future business opportunities, expected
financing sources and related matters. These forward looking statements are based on current expectations, estimates, assumptions and beliefs of management, and words such as "expects",
"anticipates", "intends", "believes", "estimates", and similar expressions are intended to identify such forward looking statements. Since this information is based on current expectations that
involve risks and uncertainties, actual results could differ materially from those expressed in the forward looking statements. We assume no obligation to update any forward-looking statements
or reason why actual results might differ.
Plan of Operation Over the Next Twelve Months
We have no operating history prior to December 16, 1997. We have no revenues from the sale of products to date and have funded our activities through the sale of our common stock and
through loans by our shareholders.
During the next twelve months, we must raise approximately $4,500,000 to complete the development of the Ebaf Assay and the Telomerase Assay and to gather the preclinical data for the FDA.
If we are successful in raising the capital required, we estimate that it will take approximately 10 months to complete the development of the Ebaf Assay and to gather its preclinical data and we
estimate that it will take approximately 14 months to complete the development of the Telomerase Assay and to gather its preclinical data. It is our understanding that preclinical data will be used
to determine the extent of the clinical trial. The clinical trial is necessary to obtain FDA approval. If the preclinical data is acceptable to DOCRO and us, then we will meet with the FDA to
determine the extent of a clinical trial. We estimate that a clinical trial for the Ebaf Assay will last approximately 8-12 months and will cost us $8-$10 million. We estimate that a clinical trial for
the Telomerase Assay will last approximately 8-12 months and will cost us $8-$10 million.
Cash Requirements
During the next twelve months, we will require approximately $4,500,000. Of this amount, $1,495,000 is required by our agreement with DOCRO to develop the Ebaf Assay and to gather the
preclinical data for the FDA, $1,859,000 is required by our agreement with DOCRO to develop the Telomerase Assay and to gather the preclinical data for the FDA, $124,527 is required by our
sponsored research agreement with UMB, $400,000 is our estimate of the cost for Dr. Tabibzadeh's continued scientific investigation of ebaf for one year and $600,000 is our estimate of the
operating expenses of the Company for one year. There is no assurance that the $4,500,000 will be available to us on acceptable terms when we needed it. Any additional capital may involve
substantial dilution to the interests of our existing shareholders.
Product Development and Research Plan for the Next Twelve Months
Ebaf Assay If we are successful in raising the $1,495,000 required, DOCRO will complete the development of the Ebaf Assay and will then gather the preclinical data for the FDA. We estimate
the development and data gathering process will take about 10 months. Our agreement with DOCRO states that DOCRO will assess the current technical and clinical performance of the existing
ebaf reagents as provided by Dr. Tabibzadeh. DOCRO must then develop purified ebaf antigens for all four known forms of ebaf protein expressed in human tissue. Next, DOCRO will raise a
variety of monoclonal antibodies and polyclonal antibodies to these various antigens to determine if any ebaf protein is overexpressed in the tissue, blood, other fluids of people diagnosed with
colorectal cancer when compared to similar specimens from apparently healthy, normal people and to specimens from people diagnosed with other malignant or non-malignant diseases. If an
ebaf protein is determined by DOCRO to be overexpressed in malignant disease and not in non-malignant disease or apparently healthy normals and we agree, DOCRO will then develop an
enzyme immunoassay for such ebaf protein to confirm the results in the blood or other fluid specimens of a statistically significant number of patients (maximum of 400).
Telomerase Assay If we are successful in raising the $1,859,000 required, DOCRO will complete the development of the Telomerase Assay and will gather the preclinical data for the FDA. We
estimate the development and data gathering process will take about 14 months. Our agreement with DOCRO states that DOCRO will assess the current technical and clinical performance of the
existing telomerase reagents as provided by Dr. Highsmith, then for DOCRO to develop or obtain purified telomerase antigens (including various peptides and, if possible, native and
recombinant protein, for known forms of the telomerase protein/nucleic acid complex) expressed in humans. DOCRO will then raise or obtain a variety of monoclonal antibodies and polyclonal
antibodies to these various antigens to determine if any telomerase antigen is overexpressed in the tissue, blood, other body fluids, and other specimen matrices from humans diagnosed with lung
or other cancers when compared to similar specimens from apparently healthy, normal humans and from a variety of humans diagnosed with other non-malignant diseases. Further, if a
telomerase antigen is determined by DOCRO to be overexpressed in malignant disease and not in non-malignant disease or apparently healthy normals and Lexon agrees, DOCRO shall develop
an enzyme immunoassay for such a telomerase antigen to confirm the results in the blood or other fluid specimen matrix of a statistically significant number (maximum of 400) of patients.
Expected Purchase or Sale of Plant and Significant Equipment
None.
Expected Significant Changes in Number of Employees.
None. |
