Affinity Therapeutics

Drug delivery grafts for immediate vascular access and reduced failure rates in hemodialysis patients.

Sean T. Zuckerman, Horst von Recum, Paul Olson

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#05

Total Interviews: 128

Weekly Average: 13

PI C Level Industry Expert

What we thought initially

• ~400,000 Hemodialysis pts in US

• ~80,000 pts with AV Graft

• Target is ~50% of market

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TAM = 400,000 pts

SAM = 80,000 pts

Target = 40,000 pts Source: US Renal Data Service, 2013 Annual Report

What we thought initially

• Affinity’s graft would be so good we could increase market share of grafts

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TAM = 400,000 pts

SAM = >>> 80,000 pts

Target = >>> 40,000 pts Source: US Renal Data Service, 2013 Annual Report

Vascular Access

• Long term vascular access critical for hemodialysis

• Arteriovenous (AV) grafts common but suboptimal option4

Coated AV Graft for Long Term

Vascular Access

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BLOOD

Time

BLOOD

BLOOD

BloodBLOOD

Normal AV Graft lifespan

BLOOD BLOOD

Smooth muscle cells

AV Graft

Affinity’s coating

Affinity’s Graft lifespan

Steve said…

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So we did…

• Interviewed 128 customers starting with

– Nephrologists

– Vascular Surgeons

– National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO)

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So we did…

• Interviewed 128 potential customers

– Nephrologists

– Vascular Surgeons

– National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO)

– Dialysis Clinics

– More nephrologists

– Patients

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Initial Canvas

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Medical Device Co’s

Vascular Surgeons & Nephrologists

Dialysis Pts

Increase sales

Decrease stenosis rates

Ease pain & hassle

Preclinical studies

Large animal Proof of Concept studies

CROs

Value Analysis Committee

IP Licensing

Acquisition

CROs SBIR grants

Publish

Medical Device Co’s

Initial Canvas

10

Medical Device Co’s

Vascular Surgeons & Nephrologists

Dialysis Pts

Increase sales

Decrease stenosis rates

Ease pain & hassle

Licensing

Acquisition

Publish

Week 2 Canvas

11

Decision Maker @ Medical Device Co’s

Vascular Surgeons,

Nephrologists, Interventionalists

Dialysis Pts

Increase sales

Decrease stenosis rates 50%

Ease pain & hassle

Preclinical studies

Large animal Proof of Concept studies

CROs

Value Analysis Committee

IP Licensing

Acquisition

CROs SBIR grants

Publish

Medical Device Co’s

Nat’l Kidney Foundation

Center for Devices & Radiological Health

Customer Interviews Patient Workflow

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Neph-rologist

Pt Vascular Surgeon

PtVascular Access

Implanted

Pt

Pt

DIALYSIS!

Pt

Interventionalist

• Nephrologist (loosely) owns the patient

• Vascular surgeons typically choose access type• Sometimes

interventionalist implants

Piggy-Back our MVP on MarketedGore Triple-Layered AcuSeal™

• “Sandwich” coating between layers

• Newer product = smaller market share

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Week 6 Canvas

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Decision Maker @ Medical Device Co’s

Vascular Surgeons,

Nephrologists, Interventionalists

Dialysis PtsIncrease sales

Decrease stenosis rates 50%

Ease pain & hassle

Preclinical studies

Large animal Proof of Concept studies

CROs

Value Analysis Committee

IP Licensing

Acquisition

CROs SBIR grants

Publish: JAMA, Circulation, J Vasc

Surgery,

Medical Device Co’s

Nat’l Kidney Foundation

Center for Devices & Radiological Health

Admin Contractor @ CMS

KOL

Conference: Kidney Week

Increase graft life 25%

Week 6 Canvas

15

Decision Maker @ Medical Device Co’s

Vascular Surgeons,

Nephrologists, Interventionalists

Dialysis PtsIncrease sales

Decrease stenosis rates 50%

Ease pain & hassle

Preclinical studies

Large animal Proof of Concept studies

CROs

Value Analysis Committee

IP Licensing

Acquisition

CROs SBIR grants

Publish: JAMA, Circulation, J Vasc

Surgery,

Medical Device Co’s

Nat’l Kidney Foundation

Center for Devices & Radiological Health

Admin Contractor @ CMS

KOL

Conference: Kidney Week

Increase graft life 25%

Revisited the Graft Market

• CPT Code: ~$1000 reimbursement

• $40 million Target Market

• PMA likely costs $10s of millions…

16

TAM = 400,000 pts

SAM = $80 Million

Target = $40 Million Source: US Renal Data Service, 2013 Annual Report

Revisited the Graft Market

• CPT Code: ~$1000 reimbursement

• $40 million Target Market

• PMA likely costs $10s of millions…

• Rethink MVP

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TAM = 400,000 pts

SAM = $80 Million

Target = $40 Million Source: US Renal Data Service, 2013 Annual Report

2 Possible MVPs

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Coated Graft

Stand alone “wrap”

FDA: Likely PMA(Predicate CDRH alone)

FDA: Likely PMA(CDRH + CDER)

2 Possible MVPs

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Coated Graft

Stand alone “wrap”

FDA: Likely PMA(Predicate CDRH alone)

Existing CPT code coverage

FDA: Likely PMA(CDRH + CDER)

New HCPC code (~3 yr)

2 Possible MVPs

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Coated Graft

Stand alone “wrap”

FDA: Likely PMA(Predicate CDRH alone)

Existing CPT code coverage

FDA: Likely PMA(CDRH + CDER)

New HCPC code (~3 yr)

Drug-eluting Wrap: Works with Fistulas or AV Grafts

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Wrap

Adapted from Paulson WD et al. Nephrol Dial Transplant (2012);27: 1219-1224

OR Fistula

Potential wrap market is ≥ 3X AV Graft market size!

Design Flaw Nearly Derailed Concept

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Wrap

Adapted from Paulson WD et al. Nephrol Dial Transplant (2012);27: 1219-1224

OR Fistula

Interview 82 = potential, “Uh Oh” moment…

Interview 116 (KOL) Allowed us to Detect

and Correct: Wrap Venous Tissue Only

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Final Canvas

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Decision Maker @ Medical Device Co’s

Vascular Surgeons,

Nephrologists, Interventionalists

Dialysis Pts

Increase sales

Decrease stenosis rates 50%

Ease pain & hassle

Preclinical studies

Large animal studies

CROs

Value Analysis Committee

Licensed IPLicensing

Direct Sales

CROs SBIR grants

Publish: JAMA, Circulation, J Vasc

Surgery,

Medical Device Co’s

Nat’l Kidney Foundation

Center for Devices & Radiological Health

Admin Contractor @ CMS

KOL

Conference: Kidney Week

Increase graft life 25%

Increase time to 1st

intervention 25%

Licensing

Milestone Payments

Affinity’s IP

Advisory Board

License IP

Freedom to Operate

IP costs

Final Canvas CS-VP

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Decision Maker @ Medical Device Co’s

Vascular Surgeons, Nephrologists,

Interventionalists

Dialysis Pts

Increase sales

Decrease stenosis rates 50%

Ease pain & hassle

Licensing

Direct Sales

Publish: JAMA, Circulation, J Vasc

Surgery,

Conference: Kidney Week

Increase graft life 25%

Increase time to 1st

intervention 25%

Final Canvas KA-KR-KP

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Preclinical studies

Large animal studies

CROs

Value Analysis Committee

Licensed IP

Medical Device Co’s

Nat’l Kidney Foundation

Center for Devices & Radiological Health

Admin Contractor @ CMS

KOL

Affinity’s IP

Advisory Board

License IP

Freedom to Operate

What’s next?• Freedom to Operate

• Continue vetting drug-eluting AV graft and wrap MVPs

• Talk with Gore re: interest (possibly Bard)

• Cultivate relationship with KOL Dr. Timmy Lee at UAB (Interview 116)

• Potential clinical and commercial relationship.

• Use Sales and Medical Science relations to build out KOL and Institutional relationships

• Harvard-associated hospitals

• Washington University/Barnes-Jewish

• University Hospital at Case Medical Center

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Phase II SBIR Grant

• Affinity plans to submit a Phase II SBIR proposal after a minor pivot.

• This proposal will be submitted in 2016 because Affinity has a two year SHIFT award.

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Investment Readiness Level

Final Slide – whew!

• Final Video on Youtube: http://youtu.be/SYWmiJgDnAs

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Sean Zuckerman Horst von Recum Paul OlsonPI C Level Industry Expert