Establishing Preclinical Development Operations in China

1. Establishing Preclinical Development Operations in China Ming Guo, Ph.D. VP Pharmaceutical Sciences & Manufacturing SABPA Pacific Forum Nov. 4, 2006

2. “Peer into the biotechnology industry's crystal ball, and the shape you see might look a lot like Ascenta Therapeutics” “Company is a model of efficiency for the drug development industry” San Diego Union Tribune October 27, 2006

3. Ascenta Profile • Private Oncology Development Company • Founded in September 2003 in San Diego with IP from NCI & U. Michigan • Now with >40 employees in San Diego, Shanghai and Philadelphia • Expert, efficient & economical oncology business model • Ascenta team is highly experienced in oncology drug development • Early discovery is generated externally via academic alliances • Preclinical pipeline is progressed in a wholly-owned Shanghai subsidiary • Clinical trial enrolment optimized by US bicoastal site management organization • Ascenta’s apoptosis pipeline is rapidly advancing and highly competitive • Product pipeline focused on Bcl-2, MDM2 and XIAP apoptosis targets • AT-101 is an oral pan-Bcl-2 inhibitor • AT-201 is an oral inhibitor of MDM2 entering Phase 1 in 2Q07 • AT-301 is an inhibitor of XIAP entering Phase 1 in 2H07 • Clinical Lead AT-101 is an oral pan-Bcl-2 Inhibitor • The only oral pan-Bcl-2 inhibitor in clinical trials (entering Phase 3 in 2Q07) • Single-agent clinical activity seen in first 3 tumors tested in Phase 2 • Synergy seen in combinations with other oral targeted agents & biologics

4. Optimization & Manufacturing Early Preclinical Early Discovery Generated Externally Late Preclinical & Clinical Development Ascenta’s Global Reach and Efficient Discovery-Development EDGE Discovery Alliance with Shaomeng Wang, PhD University of Michigan 30+ chemists & biologists San Diego Headquarters Manages discovery alliances, all IND-enabling preclinical development & West Coast clinical operations Ascenta Shanghai R&D Ctr A Wholly-owned subsidiary 15 FTEs, Chemists & Biologists All data transferred to San Diego nightly via Ascenta internet portal Philadelphia Site Management Office Manages all clinical trial sites in East & Mid-West

5. Ascenta Shanghai • Wholly-owned subsidiary • WOFE status essential for success • Inventions owned by Ascenta • Secure data infrastructure with warehousing in US • Bilingual oversight from US and Shanghai • Chemistry Capabilities • Key intermediate Synthesis • API batch scale-up (10-100 gram) • Analytical and formulation development • Formulation and stability testing • Biology Capabilities • In vitro and in vivo screening • Rodent and non-rodent PK coordinated with local Shanghai contractors • DMPK and tox assessments Ascenta Shanghai

6. Ascenta Shanghai Laboratory

7. Future Plans • To continue to build the preclinical function • Chemistry and Discovery Manufacturing lab for synthesis of key intermediates, scale-up of lead compounds, formulation and process development • In Vivo efficacy screening models • DMPK Studies • Screening Toxicology • IND enabling studies following US GLP and ICH guidelines • IND Filing with SFDA in China • IND Filing in Hong Kong and US • Clinical trials • Proof of concept trials • Part of Phase 3 multi-national trials • Registry trials for China market

8. Challenges • Acceptance by Regulatory agencies is uncertain • The first to file will be scrutinized • While the situation is improving, it will have to be closely watched • Patent protection improving but still a risk • IP law and related judicial practices are in the early stages of development • Clinical Development is less advanced than preclinical • A physical presence is necessary to realize benefits • Working through US CROs decreases the cost-savings • Close supervision will be essential to realize cost-savings & quality