SmartCells, Inc'

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SmartCells, Inc.
MedTech IGNITE SBIR/STTR Workshop June 6th, 2008

• Todd C. Zion, Ph.D.
• Co-founder, President CEO
• e-mail todd.zion_at_smartinsulin.com
• Phone [phone]
• Web www.smartinsulin.com

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Glucose-responsive SmartInsulin technology
overview

• IPC and GBM combine to form network (insoluble
  gel)
• Free glucose molecules displace the IPC from the
  GBM
• The matrix erodes from the surface inward
• The released IPC lowers glucose levels in the
  body
• The matrix stops eroding until the next glucose
  challenge

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SmartInsulin Features and Benefits
Reducing hypoglycemia growing evidence that
hypoglycemia linked to complications
Initial patient segments institutional setting,
elderly, high-risk
Cost/benefit superior to immune-based approaches
Ease of use closed loop without having to wear
anything
Glycemic variability growing concern and cant
be improved with current insulins
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SmartCells, Inc. Grant Financing Overview
SmartCells, Inc.
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Eight tips for successful grant financing

• Develop grant plus private financing strategy
• Seek out specific requests for proposals
• Surround yourself with recognized experts in the
  field
• Seek advice, BUT write it yourself
• Define your unique advantage
• Focus on specific aims
• Let the project define the budget, not vice versa
• Meet the people on the other end

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1. Develop grant plus private financing strategy

• Establish a clear business plan and overall
  financing strategy
• List the technical challenges associated with the
  business plan
• Map out the technical milestones required for
  significant risk reduction
• Arrange milestones into clearly defined projects
  with specific endpoints
• Define the amount and timing of grant support for
  those projects
• Grants are meant to bridge financing gaps
• Technical risk too high
• Development path too long and costly
• Market opportunity small but humanitarian benefit
  high
• Grants are not meant for bricks and mortar
• Demonstrate access to all necessary
  infrastructure at the time of funding
• Many corporate expenses are not allowed
• e.g. rent, patent work, legal fees, bus. dev.
  expenses, full salaries and benefits

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2. Seek out specific requests for proposals
Funding Agency X has a directive to accomplish
Y. In this proposal, we will accomplish Y in the
following ways

• Requests for Application (RFAs)
• Funds set aside for specific program objectives
  outside of the pay line
• Usually issued by single funding agency (e.g.
  NIDDK vs. all of NIH)
• Generally larger budgets and timelines allowed
• Program Announcements (PAs)
• Opportunity to address specific areas of
  scientific interest
• Potentially looser guidelines on total budget and
  timeline
• Funds generally not set aside outside pay line
• Omnibus solicitations
• Competition across all disciplines and projects
• Stricter adherence to pay line and overall budget

Visit www.grants.gov to search for federal
funding opportunities.
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3. Surround yourself with recognized experts in
the field

• No single team has all the required expertise
• Seek out experts in critical areas
• Work with them to improve your approach and ideas
• Integrate them into scientific and medical
  advisory roles
• Obtain letters of support for experts to serve as
  project consultants
• Clearly define their roles on the project

Select reviewer comments from our first grant
proposal (Funded in October 2004) Todd Zion and
Thomas Lancaster, both received their doctorate
degrees in May 2004, in Chemical Engineering, not
very experienced yet. Outstanding Consultants
Dr. Jens Brange, who is a former leading Insulin
chemist at Novo Nordisk, Dr. Gordon Weir at the
Joslin Diabetes Center and Dr. John
Schwartz. Renowned scientists/clinicians agreed
to support the project by consulting. SmartCells
, Inc. has established an outstanding Scientific
Advisory Board that appears to be very active in
the science at the company and a number of
contacts important to carrying out the
experiments.
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4. Seek advice, BUT write it yourself

• Writer must visualize him/herself performing the
  studies
• Only the internal technical champion can consider
  the project from all angles
• What are the possible shortcomings of the
  proposed work?
• What is your problem-solving strategy should
  initial plans fail?
• Whether funded or not, the act of writing the
  grant will focus your efforts
• Collect all of your data and organize in a story
  telling fashion
• Identify clear gaps in understanding and specific
  aims to be accomplished
• Consider novel approaches that remain elusive
  while in the lab
• If you care enough, youll end up writing most of
  it yourself anyway

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5. Clearly define unique advantage

• Acknowledge your competition explicitly
• Clearly identify the shortcomings of their
  approaches
• List three reasons why your approach is unique
  and better for success
• Identify what needs to be accomplished to reduce
  the risk of your approach

X, Y, and Z approaches seek to achieve the same
goals but are fundamentally limited in the
following ways Our approach will overcome those
limitations because of Reasons 1, 2, and
3. However, in order to establish full technical
feasibility, we need to accomplish the following
aims
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6. Focus on specific aims

• Not looking to fund a fishing expedition
• What are you going to accomplish?
• How are you going to do it?
• How will you measure whether you have done it?
• What are your criteria for success?

Aim 1. Scale-up Smartlnsulin by 10x while
preserving in vitro and in vivo
performance Utilizing our proprietary
Smartlnsulin GSP assay and intraperitoneal
glucose tolerance tests (IPGTT) we will
demonstrate that the scaled-up fresh (40 L batch
size) and long-term storage (30 day) formulations
have a. GSP assay setpoints that are within 10
of the lab scale (4 L) samples b. IPGTT glucose
peak concentration, time to reach glucose peak,
and time to return to fasting glucose levels are
all within 10 of those of the lab scale
samples Aim 2. Engineer Smartlnsulin
subcutaneous injection compatibility Manipulating
the Smartlnsulin material properties and using
standard histological scoring techniques and
immunoassays (ELISA kits, US Biological), we will
verify (Student t-test, p lt 0.05) that the a.
Injection site is free from fibrous or necrotic
tissue (hematoxylin and eosin stains) b. Increase
in lymphocyte (toluidine blue stain) and
macrophage (ED1 stain) localized density is less
than 10 of controls c. Increase in systemic
antibody production levels (ELISA's targeted to
the Smartlnsulin glucose binding protein
component) is less than 10 of controls
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7. Let the project define the budget

• NIH funding guidelines
• Phase I 6 months, 100K
• Phase II up to 24 months, 750K
• NIH ONLY these are just statutory guidelines NOT
  CEILINGS
• Complete proposal with a higher budget is better
  than one that has been stripped down to meet
  funding guidelines
• Reviewers will determine if budget is appropriate
  for proposed aims
• Do not inflate the budget or shorten the
  timelines to increase cash flow
• Do not underestimate your FA rate
• 40-60 not uncommon for small start-up companies
• Anything above 25 must be pre-negotiated for all
  Phase II grants

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8. Meet the people on the other end

• Get out of the black box process as soon as
  possible
• Assign a face with a name
• Present data in person to your program director
  and his/her team
• Talk to them about funding gaps, project needs,
  and additional requirements
• Update them on company progress and overall
  product development

6MM in recent Fast Track grants awarded to
SmartCells, Inc. after two years of active
engagement with NIDDK and multiple in-person data
presentation and strategic planning sessions.
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Eight tips for successful grant financing

• Develop grant plus private financing strategy
• Seek out specific requests for proposals
• Surround yourself with recognized experts in the
  field
• Seek advice, BUT write it yourself
• Define your unique advantage
• Focus on specific aims
• Let the project define the budget, not vice versa
• Meet the people on the other end

SmartCells, Inc.