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Executive Summary. LigoCyte is an immuno-regulatory drug discovery and development company. The Company has assembled a solid management team with experience in drug development and commercialization and is advancing its proprietary products from the pre-clinical stage into human clinical testing. These products address the treatment and prevention of inflammatory and infectious diseases, a $95 billion market..
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3. The Company will advance three compounds into the clinic in the next four years:
Drug candidate for inflammatory diseases (partnered with Abbott Laboratories) currently a $3 billion market projected to be $9 billion by 2010.
Norovirus vaccine to prevent diarrheal disease in children and the elderly, a $4 billion domestic market opportunity (a Phase I oral vaccine study has already been completed by the NIH and Baylor University).
CAT-6.1 mAb for fungal infections in the elderly, the immuno-compromised, ICU patients and in premature infants, a $4 billion worldwide market growing at 10% per year.
4. Company Growth Management has creatively grown the Company with a minimum of private equity capital.
Successfully securing government grants and contracts has enabled LigoCyte to fine-tune its drug development and partnering strategy and to build the infrastructure necessary to advance products into human clinical studies.
The Company is raising $15 million in equity capital, which will be focused entirely on moving products into human clinical studies.
These clinical-stage candidates will greatly influence LigoCyte’s value in anticipation of a merger, acquisition or initial public offering, and offer the potential for revenue return via pharmaceutical collaborations and partnerships.
5. Company Highlights Raised over $25 million in long-term federal grants and contracts through the NIH and the Department of Defense
License/Collaboration with Abbott Laboratories for anti-inflammatory drug development
New 24,000 sq. ft. state-of-the-art facility under construction;
Built a Board of Directors that includes noted biotech industry leaders and financing executives;
Management team consists of senior executives with direct industry experience in Fortune 500 and start-up company environments. Experienced in all facets of the business.
6. Company Highlights Contract research experience with industry leaders including Aventis, Merck, GlaxoSmithKline, Lilly, Biogen, ICOS and others;
5-year, $10.5 million contract from NIH for innate immune drug development;
Multi-year programs in place with Department of Defense to fund vaccine development;
Assembled a group of clinical advisors who are thought leaders in their fields and active in leading clinical trials;
Cash flow neutral in 2003, projected positive for 2004, 2005
7. GrowingLigoCyte Pharmaceuticalsfrom its origins inMontana ImmunoTech
8. Growing LigoCyte Founded in 1994 as Montana ImmunoTech, Inc.
5 founding members
Financed by founders, family and friends
Montana State University (MSU) Spin-out, Start-up company
MSU Technology Park
Contacted with MSU for equipment and services
Acquired MSU technologies
Anti-inflammatory mAb
Anti-fungal
Vaccine
Therapeutic mAb
9. Growing LigoCyte Business model
Partner driven for development
Company was positioned for
Discovery
In licensing of technologies
Translational development
ProteoFlow® assay discovery platform technology
Anti-inflammatory targets
Anti-infective targets
SBIR grants used to fund R&D
Service based revenue generation
ProteoFlow®
Physiological blood flow shear assays measuring adhesion and signaling
Used to establish industry alliances
Monoclonal antibody production and custom hybridoma construction
Also to support internal programs
10. Formative Concepts
12. ProteoFlow® Putting Proteomics to Work Strength of Platform = VALUE ADDED
Reduces developmental time and cost
Failing lead compounds as soon as possible
Optimizing successful compounds
Physiologic
In vitro modeling includes use of human cells
Direct visualization & quantification of the disease process
Precise analysis of adhesion and signaling interactions
Analysis of microbial adherence to host cell types
Candidate drug performance verified in in vivo model
Compound dosing and efficacy
13. ProteoFlow® Partnerships Abbott
Merck
SmithKline
Aventis
Lilly
ICOS
Biogen
Dyax
Sunesis
14. Bioadhesion & Leukocyte Driven Inflammation
16. Discovery Process for Inflammation
17. EL-246 mAb EL-246 treatment of animals, after the onset of sepsis, produced significant protection against acute lung injury.
Greatly reduced neutrophil accumulation and myeloperoxidase in the lung and attenuated sepsis-induced lung injury.
EL-246 significantly reduces myeloperoxidase levels and ischemic/reperfusion induced lung injury and mortality.
Did not result in neutrophil respiratory burst dysfunction.
Conclude that the use of neutrophil selectin adhesion blocking agents in patients appears to be unlikely to increase the risk of septic complications.
19. Bioadhesion & Infectious Disease
23. B6.1 anti-Candida albicans mAb therapeutic B6.1 hybridoma produced using C. albicans PMC adhesin immunized mice
Identified protective epitope on adhesin of C. albicans
Has anti- C. albicans protective therapeutic effect
Mechanisms of protection
MAb B6.1 causes rapid complement fixation
MAb B6.1 enhances phagocyte candidacidal activity
Highly protective in lethal systemic challenge studies in mice
Have selected fully human mAbs
24. Vaccine development
25. NIH SBIR and DOD funded R&D programs How LigoCyte has Bootstrapped Discovery and Development
26. SBIR Grants NIH E. coli Diagnostic Phase I and Phase II SBIR
Develop a rapid diagnostic test for O157:H7
Selected specific mAb
Developed isolation and amplification method
Army evaluating diagnostic potential
27. SBIR Grants NIH Phase I and Phase II SBIR “Rational design of adhesion blocking therapeutics”
Developing humanized anti-L-and E-selectin mAb,EL-246
Target indication, COPD
Successfully partnered
Co-developing
28. Biodefense
29. Biodefense Current State (1999)
Legitimate science has produced 1,500+ pathogen banks trading freely in deadly microbes.
Genetic engineering advances in the wrong hands can produce potent weapons.
Today at least 17 nations are suspected of having or trying to acquire germ weapons.
Catalogues catering to domestic radicals and militia groups carry guides to germ warfare.
FBI now fighting wave of false anthrax threats to public and private facilities.
30. LigoCyte Solution (1999) Objective: Interdiction of germ weapon threats through blocking Bioadhesion technologies
Goals: Neutralization of microbial threats via:
Bioadhesion therapeutic:
Block ongoing microbial attachment
Block toxin attachment
Bioadhesion vaccines immunizing against:
Adhesins on microbial pathogens
Lectins or carbohydrates on toxins
Bioadhesion diagnostics (rapid detection)
31. Protecting Ideas, Know-howand Processes
32. Intellectual Property Developing a Strategy
Advancing Candida therapeutic and vaccine patent protection established.
Path for broadening EL-246 anti-inflammatory patent protection.
Morgan, Bockius, & Lewis (Washington DC) retained as key patenting agents
33. LigoCyte Today
34. Continuing SBIR Effort Group B strep NIH Phase I SBIR
Group B Streptococcus vaccine for the elderly, a $2.5 billion domestic market opportunity.
35 million elderly, >65 years of age
15 million residing in rest homes
Other susceptible populations
3.6 million diabetes patients
2.5 million cancer patients
1.4 million HIV patients
High morbidity and mortality in newborns
Submitting for Phase II funding
35. Continuing SBIR Effort Anthrax spore antigen vaccine Phase I SBIR
Induce protective mucosal response
Prevent “inappropriate” macrophage-spore uptake and cytoplasmic spore germination
“Neutralize” spores before they can enter the body
Facilitates DoD efforts targeting anthrax toxins and capsule
Newly funded
36. Focus Developing therapeutic drugs and vaccines for immunomodulatory markets:
Inflammatory events => therapeutic drugs
Infectious disease => vaccines and protective antibodies
Demonstrated blockbuster areas in biotechnology
37. Core Expertise Immune focused
Molecular cell biology & microbiology
Cell surface receptors
Cell signaling pathways
Cellular adhesion molecules
Mucosal immunology
Cell-based high content assays
Protein engineering
Direct application to Biosecurity programs
38. Building Success Significant government revenue from multiple sources
Raised $24.9 million from NIH & DoD, with critical support from Senators Baucus and Burns
Ongoing, long-term programs
Cash flow break-even
Successfully built national clinical advisor network
Positive climate for recruiting experienced pharma professionals
37 employees and growing
New state-of-the-art 24,000 ft2 facility
39. Biomanufacturing The biopharmaceutical industry is expanding at double-digit rates
Major shortages in the industry’s development capacity, especially in the intermountain region
Competitive advantage for NIH drug development contracts
Major investments will be required in biomanufacturing capacity
LigoCyte can be the regional contractor for pilot-scale GMP production. LigoCyte’s value creation strategy is to remain focused on our research & development strengths and partner our clinical stage drugs to pharmaceutical and biotechnology companies that have core competencies in regulatory affairs, manufacturing, and marketing and distribution.
This strategy recognizes the increasing importance pharma & biotech companies are placing on revenues from in-licensed products. As an aside in FY 2001 in-licensed products represented 20% of big pharma revenue and are forecasted to be 40% of revenues by 2007.
Our partnering model enables LigoCyte to do what it does best, feeds the needs of big pharma, and minimizes our cash burn.
As you will see our Department of Defense and NIH funding is very impressive. While this will continue to be a strong component of of our income statement licensing fees, milestone payments, and royalties on product sales will significantly increase.LigoCyte’s value creation strategy is to remain focused on our research & development strengths and partner our clinical stage drugs to pharmaceutical and biotechnology companies that have core competencies in regulatory affairs, manufacturing, and marketing and distribution.
This strategy recognizes the increasing importance pharma & biotech companies are placing on revenues from in-licensed products. As an aside in FY 2001 in-licensed products represented 20% of big pharma revenue and are forecasted to be 40% of revenues by 2007.
Our partnering model enables LigoCyte to do what it does best, feeds the needs of big pharma, and minimizes our cash burn.
As you will see our Department of Defense and NIH funding is very impressive. While this will continue to be a strong component of of our income statement licensing fees, milestone payments, and royalties on product sales will significantly increase.
40. Strategy Develop drugs
Large demand for immunomodulatory drugs – highest sales revenue in biotechnology sector
Partner drugs
Merge our R&D strength with Pharma’s demand for new compounds, stay focused on development
Leverage government funding
NIH & DOD supporting drug discovery and development programs
Expand preclinical pipeline
Exploit core expertise in high-value area
Develop human resources
Process development, clinical, regulatory to support early-stage clinical evaluations
LigoCyte’s value creation strategy is to remain focused on our research & development strengths and partner our clinical stage drugs to pharmaceutical and biotechnology companies that have core competencies in regulatory affairs, manufacturing, and marketing and distribution.
This strategy recognizes the increasing importance pharma & biotech companies are placing on revenues from in-licensed products. As an aside in FY 2001 in-licensed products represented 20% of big pharma revenue and are forecasted to be 40% of revenues by 2007.
Our partnering model enables LigoCyte to do what it does best, feeds the needs of big pharma, and minimizes our cash burn.
As you will see our Department of Defense and NIH funding is very impressive. While this will continue to be a strong component of of our income statement licensing fees, milestone payments, and royalties on product sales will significantly increase.LigoCyte’s value creation strategy is to remain focused on our research & development strengths and partner our clinical stage drugs to pharmaceutical and biotechnology companies that have core competencies in regulatory affairs, manufacturing, and marketing and distribution.
This strategy recognizes the increasing importance pharma & biotech companies are placing on revenues from in-licensed products. As an aside in FY 2001 in-licensed products represented 20% of big pharma revenue and are forecasted to be 40% of revenues by 2007.
Our partnering model enables LigoCyte to do what it does best, feeds the needs of big pharma, and minimizes our cash burn.
As you will see our Department of Defense and NIH funding is very impressive. While this will continue to be a strong component of of our income statement licensing fees, milestone payments, and royalties on product sales will significantly increase.
41. Therapeutic and Vaccine Pipeline In fact our drug pipeline, as displayed here relies heavily on our drug development process.
Our pipeline includes anti-inflammatory antibodies, anti-infective antibodies, and vaccines.
Our Abbott partnered product will be in the clinic next year closely followed by our Candida therapeutic and Norwalk vaccine. In fact our drug pipeline, as displayed here relies heavily on our drug development process.
Our pipeline includes anti-inflammatory antibodies, anti-infective antibodies, and vaccines.
Our Abbott partnered product will be in the clinic next year closely followed by our Candida therapeutic and Norwalk vaccine.
42. Markets Anti-inflammatory mAb
Partnered with Abbott Laboratories for clinical development
Multi-billion dollar indication
Sally Wenzel MD (National Jewish), Steve Rennard MD (U Nebraska), Don Mahler MD (Dartmouth), Ed Abraham MD (UCHSC)
Candida therapeutic mAb
Premature neonates – third most common infection, second leading cause of death, 1/3 mortality rate
Adult ICU infections – hospitalized high risk populations
Danny Benjamin MD, PhD, MPH (Duke), Amar Safdar (MD Anderson)
Norwalk virus vaccine – “Stomach Flu,” “Cruise Ship Disease” or “Food Poisoning”
Critical military readiness issue
Nursing homes, hospitals, child care, travelers
23 million cases per year in the United States
Mary Estes PhD (Baylor) Our current drug development programs address major unmet medical needs. You see a healthy market size for each of our initiatives.
We will move these compounds in to early stage clinical trials which will greatly increase value and enhance our partnering capabilities.Our current drug development programs address major unmet medical needs. You see a healthy market size for each of our initiatives.
We will move these compounds in to early stage clinical trials which will greatly increase value and enhance our partnering capabilities.
43. Management Team Michael A. McCue, CEO
30 years of pharmaceutical, biotechnology & medical device management experience. Fortune 500 & start-up experience with Baxter, C.R. Bard, and Nimbus Medical
Robert R. Goodwin, Ph.D., COO
15 years of business development and operations management experience. Led technology transfer office at University of Rochester, NY.
Charles R. Richardson, Ph.D., Sr. VP, R&D
30 years of drug development and executive management experience with Ribi and Corixa Corporation.
Robert F. Bargatze, Ph.D., CSO
27 years of research and development experience. Key role in pioneering an understanding of the molecular mechanisms of inflammatory cell recruitment and mucosal immune cell recirculation at Stanford University.
Larry W. Mikkola, MBA, CPA, Director of Finance
15 years of financial management experience with Westmoreland Coal Co. and KPMG. Our Management Team works very well together. We have a tremendous amount of experience in the industry. Our backgrounds include Fortune 500 experience, start-up experience, and valuable product development experience.Our Management Team works very well together. We have a tremendous amount of experience in the industry. Our backgrounds include Fortune 500 experience, start-up experience, and valuable product development experience.
44. Highlights Proven Management, Board and Scientific Advisors
Grew company & improved financial health in difficult market
Strong product pipeline
Partnering opportunities well-timed
Trial-focused clinical advisors
Financially solid
Business model fits within current & future industry trends The LigoCyte story is impressive. From a small rocky mountain college town we have built a vibrant company. A company with excellent management, a company with commercially valuable technology, a company with remarkable financial health, and a company that is delivering on its commitments.
Our success is the result of a team that is focused and a team that concentrates on the vital few issues that really impact value creation.Our achievements are excellent indicators of future success.
I’ve enjoyed introducing you to LigoCyte – I look forward to your interest in being a part of this terrific company. The LigoCyte story is impressive. From a small rocky mountain college town we have built a vibrant company. A company with excellent management, a company with commercially valuable technology, a company with remarkable financial health, and a company that is delivering on its commitments.
Our success is the result of a team that is focused and a team that concentrates on the vital few issues that really impact value creation.Our achievements are excellent indicators of future success.
I’ve enjoyed introducing you to LigoCyte – I look forward to your interest in being a part of this terrific company.