• Formed in partnership with the Cleveland Clinic in 2003, CBLI is now also partnered with Roswell Park Cancer Institute in Buffalo, NY.

• CBLI has filed multiple sets of patents protecting its proprietary technologies and the first US, European and Eurasian patents for CBLB502 and other patents for CBLB612 have been granted.

• CBLI has received over $65 million in public equity investments and more than $66 million in US federal funding since 2003.

• CBLI’s long-term strategy is to pursue huge unmet medical needs for its compounds; however, the Company expects to receive additional benefit and near-term commercialization by capitalizing on ready defense opportunities for lead drug, CBLB502, within the next 1-1.5 years.

• The key to CBLI’s science is a simple understanding that normal cells and cancer cells die thru two different mechanisms, which enables them to be treated separately.

• CBLI‘s lead compounds and target markets include:

Protectan CBLB502 defense - for protection from and mitigation of lethal radiation exposure:

• Recombinant protein with identified target and mechanisms of action (agonist of Toll-like receptor 5), outstanding stability and insignificant animal toxicity, suitable for intramuscular and subcutaneous injections
• Estimated market for radiation countermeasures is $300- $500 million annually, with penetration. This assumes repeat purchasing due to shelf life, and US and international potential buyers (Israel, Canada, UK, India, Japan, S. Korea)
• $45 million development and conditional purchase contract awarded by US Department of Defense, September 2010
• Demonstrated unprecedented efficacy and window of protection and mitigation in rodents and non-human primates involving all major radiosensitive tissues
• Development costs covered by major contracts and smaller grants from prospective buyers (Dept. of Defense and BARDA/HHS)
• No approved drugs on the market
• Being developed under FDA’s “animal efficacy” rule requiring demonstration of efficacy in two animal species and safety, pharmacokinetic, pharmacodynamic and biomarker testing in a representative sample of healthy human volunteers
• Completed non-GLP animal studies (more than 1,000 rodents and almost 1,000 monkeys) and manufacturing development
• First human safety trial successfully completed June 2009; Second human safety trial successfully completed September 2010
• Rolling BLA filing with FDA expected 2011/2012, fast track and orphan drug status granted

Protectan CBLB502 medical - protector of healthy tissues during radiation or chemotherapy of cancer, with potential direct anticancer effects:

• Engages multiple mechanisms of action to radically reduce adverse effects of radiation and chemotherapy in animal models, including injuries of hematopoietic system, gastro-intestinal tract, skin, mucosal epithelia, etc.
• Radically improves therapeutic index by selective protection of healthy, untransformed cells and not tumors
• Addresses vast unmet medical need of “supportive care” for cancer patients universally experiencing dose-limiting treatment toxicities - a $20 billon market in the U.S. alone
• Several Phase I/II clinical trials in cancer patients planned to start 2011, including evaluation of potential direct anticancer effects.

Curaxins- Anticancer:

• Orally administered synthetic small molecules with proprietary structure designed to kill tumor cells through novel mechanism of action simultaneously targeting three signaling pathways frequently deregulated in cancer (p53, NF-kappaB and HSF1)
• Activity and safety of first generation compound (CBLC102) demonstrated in Phase II trial for hormone-refractory prostate cancer
• CBLC102 currently in a Phase IB trial in liver metastasis patients in Russia
• New generation of Curaxins with radically improved efficacy expected to enter clinic in US and Russia in 2011/2012
• Curaxin development funded through $18 million 50/50 JV partnership with BioProcess Ventures in Moscow
• Triple-targeted mechanism of action suggests strong efficacy and low chance of development of treatment resistant tumor variants (confirmed in experimental models)
• Understanding of unique mechanism of action isolates existing cancer drugs with synergistic action, dramatically increasing killing of cancer cells in experimental systems and enables rational design of clinical trials using synergistic combinations with current standards of care

Protectan CBLB612 - for hematopoietic stem cell induction and mobilization into peripheral blood:

• Synthetic compound with proprietary structure targeting and activating Toll-like receptor 2 signaling
• Single administration leads to dramatic stimulation of hematopoiesis by inducing proliferation and mobilization to peripheral blood of pluripotent hematopoietic stem cells
• Preclinical data suggests CBLB612 exceeds strength of G-CSF (Neupogen®  from Amgen) as a stem cell inducer and is synergistic with G-CSF in mice and monkeys, suggesting expedited scenario for entering medical practice as a Neupogen® enhancer
• Being developed to combat myelosuppression during chemotherapy and to replace bone marrow transplantation with stem sells collected from peripheral blood
• Complete pharmacological optimization, outstanding stability, favorable toxicological profile, suitable for intramuscular and subcutaneous administration
• Initial manufacturing completed
• Completion of pre-clinical preparation for Phase I/II trial of Protectan CBLB612 for hematopoietic stem cell induction and mobilization is planned, pending additional partnership or grant funding
• First human trial expected to show effect of drug on stem cells counts, a direct indication of efficacy making subsequent clinical trials much less risky
• Significant market interest in stem cell mobilizing drugs creates ideal positioning of CBLB612 for commercial partnering post Phase I
• License deal with Zhejiang Hisun Pharmaceutical for China signed September 2009