The document discusses a manufacturing platform for producing therapeutics in tobacco plants. It summarizes meetings with experts on commercializing biotech platforms and understanding customers. Experts advised validating the platform by producing hard-to-make proteins, focusing on technical/manufacturing customers, and understanding regulatory issues. Customers cited interest in cost-effective production and combination vaccines. Next steps include further challenging the value proposition and better understanding commercialization and decision-making processes through additional expert meetings.

1. “insero” = to plant
”gen” = gene
Manufacturing platform for Lucas Arzola (EL)
rapid, cost-effective, and scalable Karen McDonald (PI)
production of therapeutics in tobacco Vasilis Voudouris (Mentor)

2. The Business Model Canvas Target Product – therapeutics
Tobacco Suppliers R&D Speed Long-Term U.S. Government
Gene Synthesis Manufacturing Cost-Effectiveness Contracts with - CDC
Companies Regulatory Approval Robustness Government and - HHS BARDA
CMOs Licensing Scalability Vaccine - DOD DARPA
- Purification Marketing Safety Manufacturers Foreign Governments
- Fill & Finish Ease of Customization NGOs
- Packaging U.S. Supply Vaccine Manufacturers
- QA/QC -Established and
CROs Emerging Biotech
- Clinical Trials
FDA IP – Patents, Trade
Secret
Manufacturing Facility
Distribution through
Government and
Pharma Companies
Capital Investments Contract Manufacturing
Manufacturing Costs Fully Integrated Manufacturing (Sales)
Licensing Costs Licensing (Royalties)
Marketing

3. 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”

4. 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.

5. 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

6. 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.”

7. 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”.

8. 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.”

9. 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 reducesthe 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.”

10. 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 manufacturers
Have 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

11. 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…

12. More Meetings
Name 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 Oct 21
Group
Misa Sugui Scientist MedImmune Oct 24
Roman Chicz Head of External Research, North Sanofi Pasteur Oct 28
America
Ron Levy Professor in Oncology Stanford Nov
Karen Oishi Commercial Development of Plant Philip Morris TBD
Biotech Platform Specialist
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