Bolder BioTechnology has a diversified pipeline of proprietary, next-generation human protein pharmaceuticals that include potential treatments for hematological and endocrine disorders, cancer and infectious disease. These products target large, proven markets and have clearly defined clinical development paths, which will allow them to be developed cost-effectively. Annual sales of first generation products in these markets exceed $15 billion. Because of their more convenient dosing schedules, superior therapeutic efficacy and improved safety, we believe our next-generation products will be preferred by patients and gain rapid market acceptance. The unique therapeutic benefits of our products may open up new clinical indications and expand the market for these products. Bolder BioTechnology has lead development candidates in several next-generation research programs in preclinical development. Our most advanced research programs are described below. A more complete list of our research programs can be found in the Product Pipeline table below.

Product Pipeline

Next-Generation Proteins in Preclinical Development:

Growth Hormone Program
Growth Hormone stimulates production of bone, cartilage and muscle and is the body's primary hormone for stimulating growth during childhood. Recombinant human Growth Hormone is used to treat short stature, growth hormone deficiency in children and adults and HIV-associated wasting (cachexia). First generation Growth Hormone products are administered to patients by daily subcutaneous injection and have worldwide sales of $2 billion. Bolder BioTechnology is developing a highly potent, long-acting Growth Hormone product created using Site-Specific PEGylation technology. The Company's lead development candidate has a longer circulating half-life and is more effective at stimulating bone and body growth in rodent models than a leading first generation Growth Hormone product.       top

G-CSF Program
Granulocyte Colony-Stimulating Factor (G-CSF) is a protein that stimulates production of neutrophils, a type of white blood cell important for fighting infections. Recombinant G-CSF is used to treat neutropenia, promote bone marrow engraftment and mobilize hematopoietic stem cells for transplantation. Annual worldwide sales of G-CSF products are nearly $3 billion. First generation G-CSF products are administered by daily subcutaneous injection. Bolder BioTechnology is developing highly potent, long acting G-CSF analogs created using Site-Specific PEGylation and ImmunoFusion Protein technologies. Our lead candidates have longer circulating half-lives and stimulate greater and longer lasting increases in circulating levels of neutrophils and white blood cells in rodents than equivalent doses of the leading commercial first-generation G-CSF product.       top

GM-CSF Program
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) is a protein that stimulates production of multiple types of white blood cells, including neutrophils and macrophages. Recombinant GM-CSF is used to treat neutropenia, promote bone marrow engraftment and mobilize hematopoietic stem cells for transplantation. GM-CSF is being studied in human clinical trials as a potential treatment for Crohn's Disease (a form of inflammatory bowel disease) and as an adjuvant therapy for malignant melanoma. First generation GM-CSF proteins are administered to patients by daily injection and have annual worldwide sales of about $200 million. Bolder BioTechnology is developing a longer acting, more potent GM-CSF analog created using Site-Specific PEGylation technology. Animal studies indicate that our lead development candidate has a longer half-life than the leading commercial GM-CSF product and is more effective at stimulating production of white blood cells than first-generation GM-CSF proteins.       top

EPO Program
Erythropoietin (EPO) is a glycoprotein that stimulates production of red blood cells and is used to treat anemia resulting from chemotherapy, chronic renal failure and HIV drug complications, and to boost red blood cell levels prior to elective surgeries. Annual worldwide sales of recombinant EPO products are $10 billion. First generation EPO products generally are administered to patients by thrice weekly injections. Bolder BioTechnology is developing longer acting EPO analogs created using Site-Specific PEGylation and ImmunoFusion Protein technologies. Our lead development candidates have significantly longer circulating half-lives in rodents than the leading first generation EPO product, and are potent stimulators of red blood cell formation in animals.       top

Alpha Interferon Program
Alpha interferon is used to treat viral diseases such as Hepatitis B and Hepatitis C, and cancers such as melanoma, hairy cell leukemia and Kaposi's sarcoma. Recombinant alpha interferon is administered to patients by daily or thrice weekly injections. Annual worldwide sales of alpha interferon products are nearly $3 billion. Bolder BioTechnology's next generation alpha interferon product, created using Site-Specific PEGylation technology, has a significantly longer circulating half-life than alpha interferon and is more effective than alpha interferon at blocking growth of human tumors in rodents. Our product possesses both a very long half-life and high potency, which distinguishes it from competing amine-PEGylated alpha interferon products.       top

Next-Generation Products in Development
Bolder BioTechnology has earlier stage research programs aimed at developing longer acting, more potent interleukin-11, endostatin, angiostatin and beta interferon analogs. These products may provide superior therapies for treating thrombocytopenia, cancer and multiple sclerosis.       top