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

SpeedCost-EffectivenessRobustnessScalabilitySafetyEase of CustomizationU.S. Supply

R&DManufacturingRegulatory ApprovalLicensingMarketing

Tobacco SuppliersGene Synthesis CompaniesCMOs - Purification - Fill & Finish- Packaging- QA/QCCROs- Clinical TrialsFDA

IP – Patents, Trade SecretManufacturing Facility

Capital InvestmentsManufacturing CostsLicensing CostsMarketing

Contract Manufacturing Fully Integrated Manufacturing (Sales) Licensing (Royalties)

U.S. Government- CDC - HHS BARDA- DOD DARPAForeign GovernmentsNGOsVaccine Manufacturers- Established and

Emerging Biotech

Distribution through Government and Pharma Companies

Long-Term Contracts with Government and Vaccine Manufacturers

Target Product – therapeutics

What We Know

We have a novel technology platform with numerous market opportunities

Our working hypothesis – that we can scale up and commercialize our platform for production of life-saving therapeutics

Challenged this hypothesis by speaking with as many experts and customers as we could

Jon Feiber – “Since you are a platform technology, it makes sense to engage in ‘market discovery’ and ‘customer discovery’ at the same time during the next weeks”

Getting Out of the Lab!

Cast a broad net by talking to many different experts and customers in the following 3 areas:

(1) Experts in commercialization of biotech platform technologies in general

Name Title Institution

Jim Swartz Founder Sutro Biopharma

Peter Gillies Former Senior Scientist DuPont

Steve Burrill CEO Burrill & Co.

Getting Out of the Lab!

(2) Experts in the commercialization of biotech platform technologies for plants

Name Title Institution

James Petell Former Global Director of R&D Dow Agrosciences

Raymond Rodriguez Co-Founder Applied Phytologics/Ventria Biosciences

Peter Matlock Co-Founder Ventria Biosciences

Tom Turpen Founding Scientist Large Scale Biology

(3) Experts in the customer side for specific markets and target proteins

Name Title Institution

Bennie Osburn Former Dean of Veterinary Medicine UC Davis

Jim Cullor Professor in Veterinary Medicine UC Davis

Doug Crawford Associate Director QB3

Kevin Technical Support My BioSource

Customers and users

Figuring out who the customers are Burrill – “For biotech startups, customers are usually big biotech companies

looking to acquire new technologies.” Burrill – “Part of a biotech company’s value is perceived – how strong is the IP,

how innovative is the technology, what is the size of the potential market.” Swartz – “When big pharma partners with you or invests in you, that is a true

validation of your platform”. Crawford – “Focus on technical/manufacturing people within large pharma as

clients. The venturing and licensing offices seem to be more transaction oriented.”

Even for biotech, understanding the customers is very important Gillies – “We spent years doing research to develop a process. Afterwards we

asked ourselves: here’s what we’re making. What is it good for?” Rodriguez - “For our biotech platform company, we did not look at the customers

until after one year. I wish we would have done it on the 1st week.” Rodriguez – “We waited too long to talk to the FDA. I wish we would have done it

sooner.”

Changes in Value proposition

Improved Product – It is better if we can use our platform to make a product that has never been made recombinantly before

Swartz – “To validate a new manufacturing platform and gain acceptance from big pharma and the biotech industry, you have to produce “hard to make” proteins, “biobetters,” or have an enabling recovery/purification characteristic.”

Turpen – “Going after your own product that no one else can make gives you a niche. Having your own market would be a huge competitive advantage”.

Customers’ Problems

Veterinary Vaccines Cullor – “Farmers are always concerned with cost. More preventive vaccination

would be performed on animals if the cost was affordable.” Osburn – “Farmers purchase combination vaccines – you have to be able to

produce more than one product to be able to sell to farmers.”

Proteins for Research Use Kevin – “We only have a very small amount of plant-made proteins for sale.” Kevin – “ For our custom-made recombinant purified proteins, we have a couple

of manufacturing partners that handle production for us.”

General Petell – “Differences in glycosylation between human and plant proteins could be

a problem. You have to find out what the issues are.”

What was it about your platform that makes customers excited? Interested?

Cost-effectiveness Crawford – “The cost-effectiveness of your platform can help you go after non-

therapeutics markets, such as nutrition.” Turpen – “It is great that your platform reduces the equipment and infrastructure

needed to produce therapeutics.” Matlock – “Making big volumes of vaccines so cheaply that you could spit them

down the drain is a big deal.”

Customer decision making

Decision makers - talk with FDA early and often Rodriguez – “Only after we had produced a bunch of protein did we approach the

FDA and told them: look what we have. Not good, they didn’t care.” Rodriguez – “Regulatory review took 5 years. FDA reviewers will not take risks,

they are afraid of losing their jobs.” Rodriguez, on saboteurs – “A competing company convinced the FDA our

approach was too risky. They left us twisting in the wind.”

The “spending” customers/vaccine manufacturersHave not yet met with them, but we have meetings scheduled: Roman Chicz – Sanofi Pasteur, Head of External Research, North America – “I

would be happy to speak with you regarding your plant-based manufacturing platform for vaccine production.” – Meeting scheduled for Oct 28

Misa Sugui – Scientist at MedImmune – “These are very good questions. We may not be able to answer some of them in detail due to the proprietary nature of the business.” – Meeting scheduled for Oct 24

Next Steps

Keep challenging our value proposition Understand why previous companies have failed

We need to better understand how we can sell to customers, how decisions are made

Keep searching for a business model that will allow us to commercialize our technology

Not enough data - we need to talk to many more experts and customers…

More MeetingsName Title Institution Date

Pete Bernardoni Managing Director Wavepoint Ventures Oct 18

John Aikens CTO/Founder Proterro Oct 18

Various Investors Angel Investors Sacramento Angels Oct 18

Michael Plesha Bioprocess Engineer Novartis Oct 19

Ann Arvin Committee Member President’s Vaccinology Working Group

Oct 21

Misa Sugui Scientist MedImmune Oct 24

Roman Chicz Head of External Research, North America

Sanofi Pasteur Oct 28

Ron Levy Professor in Oncology Stanford Nov

Karen Oishi Commercial Development of Plant Biotech Platform Specialist

Philip Morris TBD

Henry Daniell Founder Chlorogen TBD

Mike Murray Former New Technology Leader Dow Agrosciences TBD

James Cregg Professor, Platform Tech Expert Keck Graduate Institute TBD

Eric Langer Managing Partner BioPlan TBD