Vascular Therapies PPT

2. 2
million
Ref: Edidemiology of chronic kidney disease: an update for 2022. Csaba P.
Kovesby. National Institute of diabetes and Digestive and Kidney Disease.
Healthinfo@niddk.nih.gov
CONFIDENTIAL
800
people globally are affected by
chronic kidney disease (CKD)
More than
million
ADVANCED CKD
ESKD
TX or DIALYSIS
3-5 year
wait for kidney
transplant
Over 100,000
on transplant list
Only 35%
survival rate
at 5 years
89%
of dialysis patients
are on hemodialysis

3. CONFIDENTIAL
An AV Fistula is created by a surgical or
endovascular procedure to connect the
vein and artery
Vascular Access is the Lifeline for Hemodialysis Patients
After the vessels are connected,
the vein should dilate and the
wall thicken to be suitable for
2-needle dialysis.
This process is known as
Fistula Maturation
Brachial Artery
Cephalic Vein
Radial Artery
RCF
Radio-cephalic (RCF) or Brachio-cephalic (BCF)
AVFs/year globally
660,000
BCF
3

4. ARTERY
VEIN
STENOSIS
Many AVF fail to provide adequate blood flow
for dialysis due to a narrowing (stenosis)
Stenosis is a Major Problem that Threatens AVF Usability
CONFIDENTIAL
Reference
1. Lee, T., Qian, J., Thamer, M. & Allon, M. Tradeoffs in Vascular Access Selection in Elderly Patients Initiating Hemodialysis With a Catheter. Am J Kidney Dis 72, 509–518 (2018).
4
30-60%
of AVF are not suitable for
hemodialysis and require a
reintervention or a new access
PAINFUL
EXPENSIVE
MISSED TREATMENTS

5. Sirolimus is Clinically Proven to Reduce Stenosis
Sirolimus coated medical
devices have been implanted
to prevent the formation of
intimal hyperplasia*
Over 6 million
*Estimates based on public information 5

6. CONFIDENTIAL
A Potential Solution for Vascular Stenosis
6
SIROLIMUS + COLLAGEN
LOCAL DRUG DELIVERY
BIORESORBABLE
Applied around
the vessels prone
to stenosis

7. 20 U.S. sites, 29 surgeons
243
CONFIDENTIAL
7
ACCESS Trial – Initial Phase 3 Clinical Study
U.S. randomized, prospective, multi-center, single-blind
118
125
Results
No statistical difference
between Sirogen and
controls in prespecified
endpoints
No safety issues
Age/risk
imbalance between
Sirogen and controls
(p = 0.04)
Sirogen
Single Dose Intraoperative
Controls
Standard of Care

8. > 50y > 60y > 65y > 70y > 75y
CONFIDENTIAL
Sirogen Was Highly Effective in Elderly Patients
Post Hoc Analysis - AVF Maturation Outcomes by Age in Randomized ESRD Patients
87.7% 91.1% 90.9%
96.3% 100.0%
79.6%
74.2%
60.0%
46.2%
55.6%
Sirogen Control
8
Sirogen
Control

9. 79%
40%
Clinical Fistula Maturation (FM)
Sirogen Controls
Higher Cumulative Proportion of Clinically Mature AVF
Post-hoc results from ACCESS. FM is primary endpoint for ACCESS 2
Events/Total D180 KM Est.
27/36 75.6%
6/15 41.7%
+Censor
Stratified Log-Rank: p=0.016
Stratified H-F: p=0.009
D180 KM Comparison: p=0.019
Sirogen
Controls
Stratified Weighted
Log Rank p = 0.009
9
39%
Point
Difference
High Risk Cohort from ACCESS

10. Time interval
from access
placement to
abandonment
or end of
follow-up
Fewer AVF Abandonments with Sirogen
Post-hoc analysis from ACCESS. Secondary endpoint in ACCESS 2
Controls
Sirogen
Stratified Log Rank
p = 0.001
10
High Risk Cohort from ACCESS

12. Randomized
patients
120
Patient
characteristics
≥65 years
At least 30%
females
Fistula
location
RCF
12
Primary
endpoint
Fistula
maturation
(6 months)
Secondary
endpoints
FSD12
(12 months)
Secondary
patency
(12 months)

13. 13
Estimated U.S. Regulatory Approval Timeline
Sirogen AV fistula indication (ACCESS 2 Trial)
Orphan Drug designation + Fast Track status
2023
Complete
enrollment
in ACCESS 2
2024
Primary
endpoint
readout
2025
NDA
submission
2026
FDA
approval

14. $1,259
$4,058
Sirogen is Expected to Provide Cost Savings
Total savings per patient based upon Sirogen outcomes in ACCESS compared to medicare costs for literature-based AVF outcomes
*Interventions for AVFs include procedures performed before fistula needs to be replaced, such as: administration of antibiotics, thrombolytics, and angioplasty
**Other interventions after AVF failure include receiving a new catheter, a new AVF, or a graft
***Catheter interventions include incremental removals, replacements, repositioning and thrombolytics for patients not receiving Sirogen
$2,478
$5,360
$1,843
$3,584
$13,265
$1,593
$5,133
$5,317
YEAR 2
$6,726
YEAR 3
YEAR 1
Catheter Infection
Hospitalizations
Catheter
Interventions***
Interventions
for AVFs*
Other interventions
after AVF failure**
$25K
Total 3-year savings per
patient with SirogenTM
Boston Healthcare Associates Analysis
March 2021

15. Sirogen U.S. Reimbursement
CONFIDENTIAL
15
of AVF surgeries
performed in an
outpatient setting
85%
Covered under the
Medicare Outpatient Prospective
Payment System (OPPS)
Post pass-through payment based
upon adoption, cost effectiveness
and patient access $
 Drug reimbursed + 6%
 Pass-through status for ~3 years

16. Applied to the venous
anastomosis at the time
of AVG surgery
Sirogen Halbert
AVG – Primary Patency
76%
41%
Sirogen results from Phase 2. Halbert Dec 2020 Meta-analysis of 3,381 AVG Patients
16
CONFIDENTIAL
Sirogen Next Indication: AV Grafts
ACCESS 3 AVG trial to expand indication – Phase 2 already complete

17. 6.0 9.2
34.6
21.6
72.9
82.7
154.6
LATM EU US Asia
AV Grafts AV Fistulas
AV Access Total Potential Market
Total AVF and AVG annual procedures = 661,400 and 71,400 respectively (732,800 total). ASP is ~$10,000 per procedure.
Data from 2019 USRDS and reference articles on file
$7.3B+
AVF and AVG Annual Procedures (000’s)
17
351.2

18. Leadership Team
18
John McDermott
Chief Executive Officer
Sriram Iyer, MD, FACC, FSCAI
Founder,
Chief Scientific Officer
Paul Barkofsky
Vice President,
R&D
Maureen Harrison
Vice President,
Quality Assurance
Ronald Eggan, Jr.
Senior. Director
Manufacturing
30+ years of executive leadership in private and public vascular
medical technology companies. Has developed and launched
multiple market leading products
Interventional cardiologist and vascular medicine specialist with over 30 years of patient care
and clinical trial experience. Former Associate Chairman of the Department of Cardiology and
the Director of Peripheral Vascular and Carotid Interventions at Lenox Hill Hospital NYC
20+ year career in the medical device, drug delivery, and specialty
chemicals fields specializing in new product and process development
25 years of leadership experience in medical device manufacturing
and engineering operations. Black belt certified in process and lean
manufacturing.
30-year career in the life sciences industry with leadership roles in
global pharmaceutical and biopharmaceutical research companies.
IMPR
A
Joined VT in 2005 as its first employee. Rosanne has 30 years of
experience in operations, supply chain, marketing and clinical education.
Rosanne Terraciano
Vice President
Operations
Rakesh Raghubanshi
Senior Director
Clinical Affairs
Joined VT in 2007. Rakesh has 20+ years of experience in both
pharmaceuticals and medical devices. Has successfully managed multiple
IND/IDE clinical studies and led several regulatory filings including three NDAs.

19. 19
$8M Financing – Use of Proceeds
ACCESS 2 Clinical
Trial
Complete AVF
enrollment in 2023
Primary endpoint
readout in 2024
Manufacturing
Process
enhancements for
commercial scale
CMC documentation
and NDA readiness
Pre-NDA meeting with
FDA in 2024

20. 20
The only therapeutic in a Phase 3 clinical study
designed to improve AV access outcomes for
millions of patients suffering from ESKD

21. For Additional Information:
John McDermott
Chief Executive Officer
jmcdermott@vasculartx.com
602-684-7309
CONFIDENTIAL