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
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
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
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.