1 / 45

binding science. better medicine.tm

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..

Olivia
Download Presentation

binding science. better medicine.tm

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


    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.

More Related