Government & Public Health Initiatives

CBLB502 Defense RoundtableOctober 21, 2009

Edward Martin, MD, Rear Admiral (Ret.)A distinguished 40‐year career in public service and private sector:

• Commissioned in the PHS in 1975

• Retired in the rank of Rear Admiral (1998)

• Served two terms as Acting Assistant Secretary of Defense for Health Affairs, and, prior to this appointment, as Principal Deputy Assistant Secretary of Defense (Health Affairs).

• Dr. Martin exercised day-to-day executive management and oversight over all DoD health policies, programs, and activities within the Military Health System (MHS). The Nation’s second largest health care system, the MHS, delivers care to over 9 million beneficiaries through a worldwide network of > 500 hospitals and clinics, and provides military beneficiaries with a triple-option health program.

• Senior VP and CMO at SAIC (2000-2004)

• Co-founder and Chairman of Martin Blanck & Associates

Michelle Ross, DVM, MS, PhDAn internationally recognized leader and expert in CBRN threat countermeasures and public health strategies in response to counterterrorism:

• Over past 15 years, Dr. Ross has been a leader in CBRN Medical Defense in positions from the laboratory bench to developing national defense policy

• Key assignments included: Director of Medical Chemical, Biological, Radiological, and Nuclear Defense Policy for the Office of theSecretary of Defense, advising the Assistant Secretary, Health Affairs on developing policies and programs for the prevention of mortality and morbidity and furthering individual health protection for all U.S. Forces against CBRN threat agents

• Earlier, Dr. Ross served as the Deputy Commander of USAMRICDand CBRN Medical Advisor to the Office of the Secretary of Defense/ChemBioDefense program and the Defense Threat Reduction Agency/CBD (DTRA)

• Senior Partner for Biodefense and Public Health Programs with Martin Blanck & Associates

• Senior VP of Public Health and Government Services at CBLI

Government & Public Health Initiatives

CBLB502 Defense RoundtableOctober 21, 2009

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This presentation includes forward-looking statements and predictions, including statements about potential revenue-bearing transactions, the market potential of CBLI’s technologies and product candidates, and the potential value of pipeline

products. These statements represent the Company’s judgment as of the date of this presentation and are subject to risks and uncertainties that could cause actual

results of events to differ materially from those expressed in such forward-looking statements. In particular, CBLI faces risks and uncertainties that it may not be able to sustain its business model, that revenues may be lower or expenses higher than

projected, that product sales may not increase, that development of product candidates in the Company’s pipeline may not succeed or that commercial

transactions may not go forward as planned.

Safe-Harbor

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Agenda

• The Nuclear/Radiological Threat

• Public Health Challenges• National defense policy• CBLI’s role

• US Government Investment• Project BioShield• Government contracts

• International Partnerships• Understanding of the opportunity• Potential for partnership

• Strategic Planning• FDA licensure• Marketing• CBLI’s opportunity

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• The global threat of a terrorist nuclear or radiological event continues to head the list of all agencies involved in domestic security and public health preparedness

• A terrorist attack could result in the exposure of 10’s to 100’s of thousands of people resulting in death, severe injury or long term risks, such as cancer

• IOM Report: Assessing Medical Preparedness to a Terrorist Nuclear Event, June, 2009 (prepublication copy)

• There is currently no approved drug that can protect from total body irradiation

• CBLB502 has unprecedented efficacy both before and afterirradiation

Medical Radiological Defense: A Global Concern

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Public Health Challenges

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Stopping National CBRN Terrorism:What’s Important?

• Awareness of the Risk– Across spectrum of possible CBRN attacks

• Education– First responders for Rad/Nuc Attack require special preparation

and equipment

• Readiness for the unexpected event– Stockpiled countermeasures, Diagnostic Laboratory Capacity,

Surveillance, Hospital Capacity, Develop New Therapies, Research Capacity

The consequences of lack of preparedness are unacceptable

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Public Health Policy Issues• Risks of an attack or deliberate release are difficult to evaluate

and quantify and depends on intelligence

• Licensed medical countermeasures are extremely limited at present

• Development of therapies with broad spectrum efficacy is preferred

• Partnerships (Interagency and International) are essential to address the terrorist threats

BOTTOM LINE:Protection and mitigation

“take the threat off the table”

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US Government Investment in CBRN Defense

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Executive Office of the PresidentHomeland Security Presidential Directives

& CBRN National Strategies

• Homeland Security Council lead for CBRN and Emerging Infectious Disease Preparation and Response

• Report of the Commission on the Prevention of WMD Proliferation and Terrorism (December 2, 2008)

• IOM Report: Assessing Medical Preparedness to a Terrorist Nuclear Event, June, 2009 (prepublication copy)

• Other recent Initiatives:– National Strategy for Medical Countermeasures against WMD– National Strategy for Public Health and Medical Preparedness– DHHS’ Public Health Emergency Medical Countermeasures Strategy and

Implementation Plan– National Chemical Defense Strategy– U.S. Government Policy on Classified Life Science Research

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PROJECT BIOSHIELD: Department of Health and Human Services (HHS) Medical Countermeasure Development

• BioShield Act of 2004 resulted in a DHS appropriations bill (PL 108-90) and provided a discretionary reserve of $5.6 billion tofund the program through FY2013

• BioShield support continues with current appropriation

• Funding is available for countermeasure acquisition once production of licensable products is judged scientificallyfeasible

• HHS is the procuring authority

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Properties of CBLB502

• Increase survival of primates from 20 to 70% 

• Protect from GI and HP components of acute radiation syndrome (ARS); does not require additional treatment

• Can be used from 1 hour before to 76 hours after the event of radiation; at the battlefield and in the hospital 

• Has therapeutic window of >400 times in animals; is in human safety trial now 

• Single IM injection provides complete effect

• High‐yield GMP‐process in place, projected stability at room temperature > 2 years, can be self administered

• Projected price of treatment in low hundreds of dollars (depending on the order volume)

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The Department of Defense: A Strong Interagency Partner

• Requirement for protection of service members going into harm’s way, first responders, certain medical personnel, and pre- and post-exposure protection

• Responsibility for restoration and handling of remains

• Consistent investment in medical radiological R&D

• Armed Forces Radiobiology Research Institute (AFRRI): principal nuclear R&D laboratory in the nation

• Policy to procure products licensed by the FDA

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Federal Support of CBLB502 Development

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GRANT/CONTRACT TITLE AMOUNT DATES

DoD /DTRA, Med. Chem. & Biol. Defense Res.Program

Radioprotective Mechanisms of CBLB502 $1,300,000 03/07-03/10

DoD/CBMS-JPEOChemical Biological Medical

Systems Joint Project Mng. Office

BAA-07-01- Advanced Development of a Medical Radiation Countermeasure

$9,590,000 03/08-10/09

NIAID (NIH)BioShield Program

CBLB502 mitigation of radiation induced thrombocytopenia $1,230,000 09/08-03/10

BARDA (HHS)BioShield Program

BAA-08-08 -Development of CBLB502 of mitigation of HP

syndrome$15,600,000 09/08-10/10

NIH/NIAIDGrand Opportunities (GO) Grant Protectan CBLB502 $5,300,000 09/09-09/11

CBLB502 Development: Federal Contract Funding

$33M awarded since early 2008

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Protectan CBLB502• Powerful and versatile medical radiation countermeasure• Easy to manufacture, stockpile and use in the field• Fits realistic scenarios of use

Role of US Government (DoD and HHS)• Funding for the majority of remaining steps to licensure

Future customers play an integral role in product development

The “battlefield” is everywhere in the global war on terrorism

Summary

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International Partnerships

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• International terrorist concern and interest in CBLB502

• Limited/minimal medical radiological R&D investment

• 502 development update requested by potential International partners (Ministry of Defense (MOD) & Ministry of Health (MOH) in respective nations)

– UK: In-country briefing; British embassy briefing – Canada: In-country briefing – Israel: 3 in-country briefings

International Partnerships

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• Potential supplier-customer relationship– Pre-purchase of licensed product to secure timely delivery

(conditional on FDA approval)– Limited procurement of existing product before full FDA

approval for an emergency response capability

• Development partnership– Additional manufacturing and licensure capabilities– Investment in the company leading to substantial reduction of

future procurement costs

Possible International Agreements

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CBLI’s Opportunity

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Opportunity

• The radiological / nuclear threat is real and preparation is best defense

• Development and licensure of a broad-spectrum medical countermeasure adds a dimension of security to the National response capability

• There is currently no approved drug that can protect from total body irradiation

• CBLB502 addresses an urgent global need and is on track to submit the FDA licensure packet in late 2010

• National and International markets exist for partnership and investment

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Questions?

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