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PresentationJanuary 10, 2007

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BioLumeBioLume MissionMission

…..to develop and commercialize a broad library of proprietary bioluminescent proteins with multiple first-in-class applications

in diagnostic imaging, food, beverage, and cosmetics…..

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BioLume BioLume Imaging PatentsImaging Patents

• Detection and visualization of neoplastic tissues and other tissues

–U.S. 6,416,960 issued July 9, 2002–U.S. 6,596,257 issued July 22, 2003–U.S. 09/746485 filed December 22, 2000

• Broad claims e.g., “A diagnostic system containing a bioluminescence generating system”• Backed up by broad composition of matter patents

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What is Bioluminescence?What is Bioluminescence?Bioluminescence is light produced by a chemical reaction within a living organism

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Bioluminescent Bioluminescent ProteinsProteins

o

o oc

OX Y GEN

COM P L EX

CO 2

COEL ENT ERA ZINE (Z) ENZY ME"LU CIFERASE"

+ +

+o o

Visible light

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Bioluminescent Bioluminescent ProteinsProteinsBioLume’s bioluminescent proteins were cloned from various deep-sea marine organisms

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Bioluminescent Bioluminescent ProteinsProteinsSardines, Herring, Haddock, Tuna, Salmon, and Mackerel all have diets rich in bioluminescent organisms and contain luciferases and their substrate coelenterazine

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Bioluminescent Bioluminescent ProteinsProteinsFood squid observed during fishery collection

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Bioluminescent Protein Bioluminescent Protein SafetySafety

These proteins have already been tested for skin, eye, and oral toxicity (both acute and sub-acute)

These proteins were negative for mutagenicity in the Ames test.

Many pharmaceutical and university research laboratories have maintained animals expressing Luciferase, with no reports of toxicity or failure of animals or cells to thrive due to their presence.

Coelenterazine is a natural antioxidant

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Molecular ImagingMolecular Imaging

Molecular imaging represents a paradigm shift in the focus of medical imaging from the visualization of anatomy and physiology to the study of metabolic and physiological processes e.g., cancers, often in real time

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Molecular ImagingMolecular ImagingRecent advances in biotechnology have enabled in vivo molecular imaging of luciferase reporter proteins in living animals by using a cooled charge-coupled device (CCD) camera.

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Bioluminescent Bioluminescent ImagingImaging

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Molecular ImagingMolecular Imaging

Because bioluminescence imaging has minimal background activity, this technology is very sensitive for detecting light emitted from luciferases

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Bioluminescent ImagingBioluminescent Imaging

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Bioluminescence Molecular Bioluminescence Molecular Imaging with Imaging with renillarenilla luciferaseluciferase

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Bioluminescent ImagingBioluminescent Imaging

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Bioluminescent ImagingBioluminescent Imaging

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Bioluminescent ImagingBioluminescent Imaging

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Bioluminescent ImagingBioluminescent Imaging

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Skin Cancer FactsSkin Cancer Facts

• >1 million new cases of skin cancer will be diagnosed in the US this year (>10k will die)• 1 in 5 Americans will develop skin cancer during their lifetime (BCC, SCC, or melanoma) • 1 in 65 Americans were likely to develop melanoma during their lifetime• Melanoma incidence has increased 690% since 1950• Melanoma is the second most common cancer in women aged 20 to 29 Source: American Academy of Dermatology

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Skin Cancer DetectionSkin Cancer Detection

• Screening for skin cancer is a visual exam by patient or dermatologist

• Suspicious lesions get a biopsy

• Highly specific antibodies for melanoma are known and generically available

• There are no skin cancer screening kits on the market today

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Immunology of Immunology of MelanomaMelanoma

There are unique surface antigens which There are unique surface antigens which characterize melanoma cellscharacterize melanoma cells

These unique antigens can be used to target These unique antigens can be used to target highly specific antibodies, for therapy or highly specific antibodies, for therapy or detectiondetection

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Immunology of Immunology of MelanomaMelanoma

One type of surface antigen is a ganglioside One type of surface antigen is a ganglioside (GM3)(GM3)

Antibodies have been made which are directed Antibodies have been made which are directed against these gangliosides as well as other against these gangliosides as well as other melanoma surface antigensmelanoma surface antigens

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Selective melanoma Selective melanoma antibody kill melanoma antibody kill melanoma cellscells

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Bioluminescent Bioluminescent Melanoma DetectionMelanoma Detection

Luciferases can be expressed with antibodies to melanoma surface antigen(s)

Or

Luciferases can be chemically conjugated to the melanoma antibodies

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SummarySummary

• Product development opportunity combining known antibodies and developed bioluminescent proteins (no research required)• Patented bioluminescent proteins• Focused on an unmet medical need• Large market opportunity