AMBIOPHARM Inc Supplier of Peptide API Manufacturing and

AMBIOPHARM, Inc. Supplier of Peptide API Manufacturing and Services

Ambio Locations and History Chemspec Ambio. Pharm USA Shanghai Ambio. Pharm 2005 • Ambio. Pharm, registered in California, USA 2007 • Ambio. Pharm, acquired UCB Bioproducts at North Augusta, SC • Shanghai Ambio. Pharm, started at Shanghai, China 2012 • Ambio formed for developing complex generic drugs 2015 • Shanghai Ambio. Pharm built a new commercial manufacturing facility. Chemspec Ambio. Pharm, Shanghai, China

Ambio. Pharm Overview One of Leading Peptide Manufacturers in the World • Ambio. Pharm, registered in California, USA o Manufacturer of generic peptide APIs o Contract manufacturing peptide APIs for pharma and biotech worldwide • The company is one of leading major peptide manufacturers in the world o 2 commercial generic peptide APIs and 18 generic peptide APIs in the development pipelines o >100 NCE peptide CMO projects.

Generic Peptide APIs Generic Peptide API Manufacturer Generic Peptide Portfolio API’s Available Today: • Bivalirudin (DMF, FDA approved) • Eptifibatide (DMF, FDA approved) • Glucagon (DMF) • Leuprolide (DMF) • Octreotide (DMF) • Glatiramer (DMF) • Teriparatide • Nesiritide • Exenatide • Carbetocin • Liraglutide (DMF) • Corticotropin • Teduglutide • Lanreotide In Development: • Pramlintide • Ganirelix • Cosyntropin • Triptorelin • Goserelin • Linaclotide • Vasopressin

Robert Geiger VP of Quality Chris Bai Chief Executive Officer HR & Administration Ruoping Zhang VP of Manufacturing Proc Dev QA and Regulatory Quality Control Chemist Microbiologis t Jim Hampton Exec VP of Bus Dev Production Director of Sales Analytical Dev Facilities QA Manager Chemist Technician Synthesis Chemist Downstream Chemist US, EU, Canada, Asia Sales reps

Seasoned Management Team Name Role Experience Chris Bai, Ph. D President & CEO 20 years in pharmaceutical manufacturing Jim Hampton, BS Exec VP of BD and Sales 20 years in pharmaceutical business development Ruoping Zhang, BS VP Manufacturing 18 years in peptide API manufacturing Stephen Kiel, MBA, CPA CFO 35 years in financial management Robert Geiger, Ph. D VP Quality 15 years in pharmaceutical quality management Simrat Singh, Ph. D Sr. Director Operations 10 years in pharmaceutical product development Isabel Tan Sr. Director of Quality 10 years in pharmaceutical quality management Guoging Zhang Sr. Director of Mfg & Process 10 years in peptide API manufacturing Sherry Li Sr. Director of Analytical & QC 10 years in pharmaceutical quality control

Compliance & Inspection History – November 2008, FDA audit of USA site: no 483 observations – August 2011, FDA audit of USA site: no 483 observations – October 2011, s. FDA audit of Shanghai site: no observations – March 2013, FDA PAI of USA site: 4 “ 483” observations – August 2013, FDA PAI of Shanghai site: 2 “ 483” observations – October 2014, FDA PAI of US site: 1 ‘ 483’ observation – January 2016, FDA audit of Shanghai site: no “ 483” observations

Ambio. Pharm Manufacturing Sites

API Manufacturing Facility at North Augusta Building No. 200 and 300 Warehouse 60 cm HPLC Column 400 L Lyophilizer

Current API Purification Capacity 400 kg/year within Building No. 200

Non-Sterile Peptide API Manufacturing Purification Scale From 1 g to 30 kg/batch Final Peptide Ø Preparative HPLC columns, Ø ID: 5, 8, 15, 20 and 30 cm (up to 7 kg/batch) Ø ID: 45 cm HPLC Column (up to 15 kg/batch) Ø ID: 60 cm HPLC Column (up to 28 kg/batch)

Non-Sterile Peptide API Manufacturing Freeze Drying Capacity Ø Four (4) Manifold lyophilizers (up to 1 kg/batch) Ø 100 L tray lyophilizer (up to 7 kg/batch) Ø 200 L tray lyophilizer (up to 15 kg/batch) Ø 400 L tray lyophilizer (up to 30 kg/batch)

Ambio. Pharm Expanding its Headquarter at North Augusta, South Carolina, USA

API Synthesis Facility at Shanghai Building No. 1 20 kg/batch & 300 kg/year Crude Peptide Process Development, c. GMP Pilot, and Large-Scale API Manufacturing Facilities

API Synthesis and Purification Facility at Shanghai Building No. 13, Commercial Manufacturing Ded icat ed m cost anufac tu savi ngs ring lin e at la rger offers furt scal her e.

1 st to 3 rd Floor of Building No. 13 1000 L Solid Phase Reactors 5000 L Solution Phase Reactors

5 th Floor of Building No. 13 4 Purification Suites 20 cm, 30 cm, 45 cm HPLC Purification Columns

Synthesis Manufacturing Capacity 200 kg crude/batch & 2000 kg crude/year Ø 30 solid phase reactors 1 L, 5 L, 10 L, 30 L, 50 L, 80 L, 200 L (up to 20 kg crude/batch) Ø 20 solution phase reactors 10 L, 20 L, 30 L, 50 L, 80 L, 200 L (up to 40 kg crude/batch) Ø 1000 L Solid Phase Reactor (up to 100 kg crude/batch) Ø 5000 L Solution Phase Reactor (up to 200 kg crude/batch) 18

Ambio. Pharm Designing and Building a New Chinese Facility at Shanghai to be completed by 2018

Increase Peptide API Manufacturing Capacity to 400 kg/year by 2016

Final Product Released in USA Quality Control Laboratory Ø HPLC (12) Ø GC (2) Ø LC/MS (2) Ø IC Ø SEC Ø Amino acid analysis Ø UPLC Ø KF Ø Endotoxin and Bioburden 21

Process Development Center at North Augusta and Shanghai The Process development group works to achieve the following goals: – Efficacy and selectivity (reach the requirements in terms of quality) – Scalability (transferable into large to very large scale) – Productivity (good yield and recovery of the target) – Reproducibility (repeated campaigns must produce the API with the same profile) – Robustness – Safe with regard to people and environment

Analytical Development Group at North Augusta and Shanghai In parallel with the process development, analytical development provides tools that are able to: – – Monitor the process for side reactions Monitor the process to reach required purity Monitor the process to limit the residual impurities Control the final API and ensure the required quality attributes – Provides “cushion” of impurities to allow formulators more breathing room

Ambio. Pharm’s Advantage – Low Cost of Manufacturing • Close to all the major raw material manufacturing companies (amino acid derivatives and solvents) • Low cost to manufacture under fully controlled c. GMP quality system and experienced management team • Low cost on solvents DMF, a major cost for peptide synthesis on large scale US Competitor’s cost: $3, 500/ton Ambio. Pharm’s cost: $1, 450/ton • The solvent recovery system would reduce the manufacturing cost further on larger scales

Manufacturing Cost Comparison $12, 000 $10, 000 $8, 000 US Competitor (Cost US$) $6, 000 Ambio. Pharm (Cost US$) $4, 000 $2, 000 $0 50 g 200 g 500 g 1000 g 2000 g Manufacturing Scale 5000 g 10, 000 g

Ambio. Pharm, Inc. 26 n Largest peptide manufacturing capacity; actively expanding capacity to meet specific customer needs n > 100 years management experience in c. GMP n The highest technical capabilities in the peptide industry n Three manufacturing facilities to serve customers worldwide n Setting a new standard for the quality of generic APIs