1. UCSF Diagnostics Cohort
Fall 2013
Todd Morrill
Resources, Activities, Costs
1

2. Remember how we will fit DX into the BMC?
2

4. IP Resources in Dx
• Original / core license
– Licensed or filed
– Nothing to talk about unless it is protected
– Analyte, test method, reagents, apparatus, etc.
• Freedom to operate
– Much harder to get. Make reasonable assumptions
– US PTO and search engines can help
• Protection from competition
– Very hard

5. Financial Resources in Dx
• Cost to develop / burn rate
• Time to market
• Pre-launch builds
• Incremental funding if necessary

6. MammOptics
Financial / Operations Timeline
2012
Cash Reserve
Q1 Q2
Q3 Q4
Q1
Q2
Q3 Q4
2016
2015
Q1
Q2
Q3
Q4 Q1
Q2
Q3
2017
Q4
Q1
Q2
2018
Q3 Q4
Q1
Q2
$30M
$20M
$15M
$5M
Series A
$3.5 MM
System
Initialize
Proof of
Concept
Beta Prototype
Laboratory
Prototype
Clinical
Milestones
Design
Milestones
Q1 Q2
2014
$40M
$10M
Regulatory/ IP
Milestones
Q3 Q4
2013
BetaVersion
Testing
Pilot
Studies
Provisional
Patent
Technology
Licensing
6
12/4/2009
Q3

7. MammOptics
Financial / Operations Timeline
2012
Cash Reserve
Q1 Q2
Q3 Q4
2013
Q1 Q2
2014
Q3 Q4
Q1
Q2
Q3
Q4 Q1
Q2
Q3
Q4
Q1
Q2
Q3 Q4
Q1
Q2
$20M
Series B
$9 MM
$15M
Series A
$3.5 MM
System
Design
Milestones
Q2
2018
$30M
$5M
Clinical
Milestones
Q1
2017
$40M
$10M
Regulatory/ IP
Milestones
Q3 Q4
2016
2015
Regulatory / Clinical
Beta Prototype
Laboratory
Prototype
Marketable
Product
BetaVersion
Testing
Pilot
Studies
IRB /
IDE
IC and
Processin
g Patents
Application
and System
Patents
7
12/4/2009
Q3

8. MammOptics
Financial / Operations Timeline
2012
Cash Reserve
Q1 Q2
Q3 Q4
2013
Q1 Q2
2014
Q3 Q4
Q1
Q2
2016
2015
Q3 Q4
Q1
Q2
Q3
Q4 Q1
$40M
Series C
$30.5 MM
$30M
$20M
Series B
$9 MM
$15M
$10M
$5M
System
Regulatory/ IP
Milestones
Clinical
Milestones
Design
Milestones
Regulatory / Clinical
Second Release
1st
Release
Test
Publication
Pilot
Studies
IRB /
IDE
IC and
Processin
g Patents
US Interim Trials
US Pivotal Clinical
Trials
Cat III
CPT
Application
and System
Patents
8
Q2
Q3
2017
Q4
Q1
Q2
Q3 Q4
2018
Q1
Q2
Q3

9. MammOptics
Financial / Operations Timeline
2012
Cash Reserve
Q1 Q2
Q3 Q4
2013
Q1 Q2
Q3 Q4
2014
Q1
Q2
2016
2015
Q3 Q4
Q1
Q2
Q3
Q4 Q1
Q2
Q3
2017
Q4
$40M
$30M
$20M
Q1
Q2
2018
Q3 Q4
Q1
Q2
Series D
$35 MM
Series C
$30.5 MM
$15M
$10M
$5M
Launch
Design
Milestones
Second Release
Clinical
Milestones
Regulatory / Clinical
Publication
2nd Release
Test
Publication
US Pivotal Clinical
Trials
Clinical
Results
Non-Specific Codes
Regulatory/ IP
Milestones
US Interim Trials
FDA – Class II – 510 (k)
with Clinical Trials
Initial
Product
Launch
9
12/4/2009
Q3

10. MammOptics
Financial / Operations Timeline
2012
Cash Reserve
Q1 Q2
Q3 Q4
2013
Q1 Q2
Q3 Q4
2014
Q1
Q2
Q3 Q4
2016
2015
Q1
Q2
Q3
Q4 Q1
Q2
Q3
2017
Q4
$40M
Q1
Q2
2018
Q3 Q4
Q1 Q2/ IPO
M&A Q3
$50 MM
Series D
$35 MM
$30M
$20M
$15M
$10M
$5M
Launch
Design
Milestones
Regulatory / Clinical
Regulatory/ IP
Milestones
Clinical
Milestones
Publication
Clinical
Results
Post-Market Clinical
Studies
Non-Specific Codes
FDA – Class II – 510 (k)
with Clinical Trials
Specific Codes
(Cat. I CPT / APC)
Initial
Product
Launch
12/4/2009

11. MammOptics
Financial / Operations Timeline
2012
Cash Reserve
Q1 Q2
Q3 Q4
Q1
Q2
2016
2015
Q3 Q4
Q1
Q2
Q3
Q4 Q1
Q2
Q3
2017
Q4
$20M
Series A
$3.5 MM
Proof of
Concept
Q2
Q3 Q4
Q1 Q2/ IPO
M&A Q3
$50 MM
Series B
$9 MM
$15M
System
Initialize
Q1
2018
Series D
$35 MM
Series C
$30.5 MM
$30M
$5M
Laboratory
Prototype
Launch
Regulatory / Clinical
Beta Prototype
Marketable
Product
BetaVersion
Testing
Second Release
1st
Release
Test
2nd Release
Test
Publication
Publication
Clinical
Milestones
Design
Milestones
Q1 Q2
2014
$40M
$10M
Regulatory/ IP
Milestones
Q3 Q4
2013
Pilot
Studies
US Interim Trials
US Pivotal Clinical
Trials
Clinical
Results
Post-Market Clinical
Studies
Non-Specific Codes
Provisional
Patent
Technology
Licensing
IRB /
IDE
IC and
Processin
g Patents
FDA – Class II – 510 (k)
with Clinical Trials
Cat III
CPT
Application
and System
Patents
Specific Codes
(Cat. I CPT / APC)
Initial
Product
Launch
11
12/4/2009

12. © 2012 Steve Blank

13. Activities
• Development plan
• It takes a long time to get financed!
– Limited CEO resource
• Product validation aka clinical trials
– Sensitivity and selectivity specs
– Validation study: patients, time, cost
– Regulator who will oversee it

14. © 2012 Steve Blank

15. Remember how we will fit DX into the BMC?
15

16. Next week
• Slides as per the syllabus
•
Close-to-final slide on reimbursement
–
–
–
•
Close-to-final slide on regulation
–
–
–
•
What agency, division, etc. will provide approval
Estimated time-to-approval following data submission
Any other regulatory issues
Close-to-final slide of clinical trials
–
–
•
Codes you will use and associated $$ value
Justification for those codes
Estimated price, and JUSTIFY the difference!
How many samples / patients
Estimated cost in $$, time and other resources (e.g. your time)
Close-to-final slide on ecosystem
–
With flows including dollars and estimated amounts

17. Upcoming schedule
•
•
•
•
Nov 19 – Your final regular presentation
Nov 26 – No class
Dec 3 – Training session for the final
Dec 10 – Final presentations etc.
Please don’t let customer interviewing languish
during Thanksgiving, or after…

18. Open Office Hours
• Wed Nov 13 – most of the day
• Thu Nov 14 – after 2pm
• Mon Nov 18 – most of the day
Please set up the call as soon as possible in advance.
I may (not) be available short notice.