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Commonwealth Biotechnologies, Inc. A Full Service Life Sciences Contract Organization “ From Concept to Clinic” 601 Biotech Dr. Richmond, VA 23235 phone: 1-800-735-9224; 804 648 3820 fax on demand: 1-877-329-4224 www.cbi-biotech.com. Safe Harbor.
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Commonwealth Biotechnologies, Inc. A Full Service Life Sciences Contract Organization “From Concept to Clinic” 601 Biotech Dr. Richmond, VA 23235 phone: 1-800-735-9224; 804 648 3820fax on demand: 1-877-329-4224www.cbi-biotech.com
Safe Harbor Any statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties as identified in the Company's filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. No statement herein should be considered an offer of any securities. Readers are cautioned not to place undo reliance on these forward-looking statements, which speak only as the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Commonwealth Biotechnologies Inc. • CBI was founded to provide research and development services in the life sciences on a contract basis • Integrated Life Sciences Research Support • CBI is dedicated to providing the most comprehensive assembly of cutting edge technology and professional expertise in support of its client’s life sciences research, development, and production needs from “Concept to Clinic”. • Central to achieving this goal is an individual and corporate commitment to excellence and complete client satisfaction.
CBI is an EARLY STAGE CRO Drug Development Outcome Based Research Commercialization, Marketing and Distribution Phase II & Phase III Studies Reductions to Practice Trials and Testing Phase I Studies Proof of Principle Protocol Development Discovery Production Basic Research & Development
CBI’s Strengths • Broad Ranging Expertise • CBI has assembled a group of scientists with a broad range of expertise and practical experience in an array of disciplines. • Breadth of Technologies • CBI has invested in a broad variety of state-of-the-art technologies, providing a range of options to solve almost any problem. • A Collaborative Culture • CBI has crafted a stimulating, open environment where scientists collaborate among themselves and with our clients, taking on interesting challenges and developing creative solutions
CBI as the Preferred CRO • CBI facilitates one-time and strategic decisions • Short term and long term clients • Flexibility in options • GLP and non-GLP rated services • Fully accredited by CDC, CLIA, AABB, USDA, NFSTC • CBI accommodates ALL levels of service • Bench to production scales • High throughput, automation • Specialty labs • Biosafety level 3 labs • DNA reference Lab • Calorimetry and mass spectrometry labs • Cell culture/fermentation labs • High throughput DNA sequence laboratory • Peptide synthesis lab
CBI as the Preferred CRO • CBI has a large client base with extensive project experience. • Over 2900 clients, in over 1400 institutions world-wide • 80% private sector • 5% University sector • 15% government sector • CBI is small (59 persons) but populated with sophisticated skill sets • 11 Ph.Ds, 9 M.S, all at least B.S. • Full accounting and business staff capabilities • Full Regulatory Compliance capabilities • In-house IT capabilities
Teaming Agreements/Strategic Alliances • Industry Teaming Agreements • Dynport, LLC • Alion Science and Technology, in pursuit of DTRA related programs • IDIQ Contract 2002 • Battelle, in pursuit of DoD contract programs related to SBCCOM • IDIQ Contract award 2002 • Jacobs Sverdrup, in pursuit of DTRA CB programs • Strategic Alliances with Industry Partners • Fisher Scientific to vend CBI services nationwide • Intertek, ASG to seek customers on a global basis with an comprehensive array of service offerings. • Center for Functional Genomics, Albany, NY for specialized technology offerings • Kemp Biotechnologies, Inc, for large scale overexpression work • More than 200 CDAs in place
Important Milestones • November, 1992 – Founded as S Corp; 4 partners • June, 1997 – Private Placement • October, 1997 – C Corp; IPO; 3 Partners • March, 1998 – Industrial Revenue Bond • December, 1998 – Occupy 32,000ft2 building • September, 2000 – Private Placement • August, 2002 – Private Placement • June, 2004 – Private Placement • November, 2004 – Retire IRB bonds • December, 2004 – Acquire Fairfax Identity Labs • January, 2006 – License HepArrest to Prism Pharm
Commonwealth Biotechnologies Inc. • 32,000 square foot, state-of-the art facility • Secure and Classified • BSL-3 laboratory • CDC registered for select agent work • AABB, NFSTC, USDA, CLIA accredited • GSA schedule
CBI Focus • Bio-Defense Research and Development • Comprehensive Contracts • DNA Reference Lab Activities • Clinical Testing Services
Overview of Bio-Defense Related Activities • Development of novel methods to detect and measure pathogens and toxins • Development of novel methods to extract pathogens and toxins from environmental samples • Creation of new reagents for pathogen and toxin detection • Proteomics for discovery of biomarkers for select agents • Sensor development; incorporation and testing of reagents • Performance of high through-put DNA sequence analysis of pathogenic DNA for strain identification • Virus and Bacterial Genome determination • Performance of QA/QC analysis on experimental vaccines directed against select agents • Performance of analytical analyses on operational samples • Forensic DNA analysis of case samples • Production of Critical Reagents
Bio-Defense Related Validation Studies • MLVA analysis of anthracis strains – completed • Morphological Variant Analysis; anthracis strains – completed • Mass spec analysis of ricin/abrin – in progress • Butyrylcholinesterase as a scavenger for CW agents – in progress • Cell based assay for anthracis toxin - to be started in June
Comprehensive Contract Activities • QA/QC of Pharmaceutical API and Drug Release Materials • DNA sequence analysis (viral and bacterial genomes) • DNA sequence analysis (viral strain speciation) • Large Scale Antigen Production • Large Scale Antibody Production • Large Scale Peptide Synthesis • Polyclonal and monoclonal antibody production • Proteomic Analysis of drug effects • Cell banking, sterility testing, adventitious agents, restriction mapping
HHV Testing Early Cancer Antigen/Antibody Detection Diet Supplement Analysis OAS Analysis P53 Analysis Serum Hydroxylase Analysis Microsatellite Array- Early Cancer Detection Phase I and Phase II - Plaque Reduction and Plaque Neutralization Assays- VEE Vaccine study Phase I -Scavenger Enzyme Exposure to CW agents Clinical Testing Support Services
DNA Reference Lab Activities • Paternity Testing (Private, State, Immigration) • CODIS Services • Forensics Services • Mitochondrial DNA (mtDNA) sequencing • Y-chromosome STR Analysis • Specimen Matching • CID Personal DNA Profiling
Intellectual Properties Have Taken a Back Seat to Core Business Activities. • HepArrest - licensed to Prism Pharmaceuticals • Currently in GMP production • Pre clinical IND studies to start in July • Contracted projects at CBI in support of the pre clinical studies • IND filing expected by the end of 2006. • Etx CBI 040(patented) • Licensed to Prism Pharmaceuticals • Development projects at CBI planned for the current year
Intellectual Properties Have Taken a Back Seat to Core Business Activities. • AccuTracTM (patented) • AccuTrac-PTM(patented) • EIA ImmunoAssay kit • HHV Assay Platform (patent pending) • RT PERTAssay(patented)
Proposals Pending as of 5/19/06 • Government and Private Sector Customers • Range in duration from 3 mos to 8 years • Range in Valuation from $ 30,000 to $7.1million • Total Valuation in excess of $25 million • Likelihood of success ranges from 10 to 100% • Lag time between submission and award can be upwards of 6-8 months. • Lag time between award and work start is usually less than 1 month but can be as long as 4-5 months • Lag time after start before revenues are realized is generally about 1 month.
CBI Business Model • Government contracts pay the operating costs of the business • Sufficient number of contracts to meet the overhead obligations of the Company and contribute to the revenue stream • Federal contracts are generally low margin • Typically cost reimbursement, CPFF, or FFP contracts • Private sector contracts contribute to bottom line profitability • High margin • Need to focus on building private sector contract revenues • And then ….
Adverse Effects on 1Q 2006 Revenues • Budget reversions due to Katrina and the war in Iraq caused curtailment of 3 different sponsor programs • DELAYED at least until the late 3Q/early 4Q ’06 • Outright cancellation of several programs from virtually all federal agencies • GFY ’06 dollars are very scarce, more likely to see GFY ’07 dollars than ’06 dollars, but; • At least two new sponsor programs are expected to start programs at CBI in June/July ’06
Adverse Effects on 1Q 2006 Revenues • New patient cohorts for clinical trial now starting in JUNE, instead of January. • DELAYED start-up of a forensic contract pending completion of a requisite validation study (late June/July)) and re-fit of an existing lab (June) • The good news is that other forensic contract work already promised to CBI is also pending completion of the validation study
Going Forward • CBI expects to make up lost ground beginning in the 2Q: • The mix of work originally envisioned for 2006 will change dramatically, but • The clinical trial samples are now being received at CBI. • New, unanticipated contracts are starting in June/July • Work (and revenues) will accelerate in a particular toxin production contract in a newly rennovated and accredited lab just coming on-line. • All other work, including another clinical trial, appear to be on schedule.