Manufacturing platform for rapid, cost-effective, and scalable

production of therapeutics in tobacco

“insero” = to plant ”gen” = gene

Lucas Arzola (EL)Karen McDonald (PI)

Vasilis Voudouris (Mentor)

The Business Model Canvas

Cost-EffectivenessRobustnessScalabilitySafetyU.S. SupplyProduct uniformity

R&DManufacturingRegulatory ApprovalLicensingMarketing

UC DavisTobacco GrowersGene Synthesis CompaniesCMO Clinical CROsAlpha 1 FoundationTobacco Companies

IP – Patents, Trade SecretManufacturing Facility

Capital InvestmentsManufacturing CostsLicensing CostsMarketing

GrantsUpfront/Milestone Payments w/PartnersLicensing (Royalties)Virtual Biotech Company (Sales)Fully Integrated Manufacturing (Sales) (LONG TERM)

WholesalersAAT deficient patients

Distribution through Wholesalers

PublicationsConferencesLong-Term Contracts with Wholesalers

Target Product – alpha-1 antitrypsin (AAT)

Partners

Why do we need them? Technology license agreement Startup incubator space

Why will they partner with us? Campus becoming more entrepreneurial – new Chancellor is revamping the

technology transfer process, success story for UC Davis and Sacramento area

What’s the cost of the partnership? Licensing costs – upfront payment, assume patent costs Incubator space lease agreement

Partners

Why do we need them? For the clinical trials – the foundation manages the alpha-1 research registry, a

confidential database of diagnosed alpha-1 deficient individuals and alpha-1 carriers willing to participate in research, from filling a research questionnaire to enlisting in clinical trials

For research funding - they have provided $42M in funding for alpha-1 research and programs to date

Why will they partner with us? Because of their mission – dedicated to providing leadership and resources

that will result in increased research, improved health, worldwide detection, and a cure for the disease. Using our manufacturing platform to make AAT more affordable, safer and reliably available would be an incentive for them to partner with us.

What’s the cost of the partnership? No direct costs, although personnel time for relationship building, grant

writing, etc.

Partners

Why do we need them? Raw Material Supply and Expertise – they have the infrastructure and know

how to grow tobacco

Why will they partner with us? New Market – they are looking for new, high value markets for their crops in a

declining smoking tobacco market

What’s the cost of the partnership? Research and Development – agricultural practices and germplasm may need

to be modified for new application Long-term contracts – payments for harvested tobacco crops Relationship building, monitoring and development

Tobacco Farmers

Partners

Why do we need them? Funding – we are repurposing tobacco for the production of therapeutics

Why will they partner with us? Positive PR – they are looking for new and better uses for tobacco (using

tobacco to provide a treatment for hereditary-based emphysema).

What’s the cost of the partnership? Public perception? – associating our company with them might transfer strong

feelings from the public towards us

Tobacco Companies

Partners

Why do we need them? For product co-development – provide funds and resources for research,

product/process development, clinical trials and regulatory approval

Why will they partner with us? Large pharma companies are constantly seeking new technologies and

products for their pipeline

What’s the cost of the partnership? Exclusive rights to the product – joint venture for product co-development,

startup is acquired if product is successful

Large Biotech Companies

Partners

Why do we need them? To complete our manufacturing – use our core technology to make AAT,

outsource our purification, fill and finish, we can focus on our core competency without increasing overhead costs, infrastructure and number of staff

Why will they partner with us? Because it’s their business – CMOs act as single source providers, offer

specialized and comprehensive manufacturing services

What’s the cost of the partnership? Service fee – a manufacturing contract is negotiated that specifies process

development work, crude extract to process, amount of product to be purified, quality specifications, formulation, price, and timeline

Contract Manufacturing Organizations

Partners

Clinical Research Organizations

Why do we need them? Preclinical and human clinical trial expertise and process manufacturing

support for Chemistry, Manufacturing and Control (CMC)

Why will they partner with us? Because it is their business – CROs assist partners in drug discovery and

development by providing them with customized high-quality research models and preclinical and clinical support services.

What’s the cost of the partnership? Consulting and Service Agreements – Preclinical, Phase I, Phase II, and Phase III,

process manufacturing support QC, QA & Regulatory compliance costs of manufacturing facility – we need

qualified staff for internal regulatory oversight

Partners

Why do we need them? Distribution – get our product to AAT deficient patients

Why will they partner with us? Because it’s their business – wholesalers mark up the product price when it

goes through their channels to the retailers

What’s the cost of the partnership? Long term contracts – assure pricing and steady supply of product

Wholesalers