Post on 03-Oct-2020
Investor Event
April 20, 2017
National Kidney FoundationSpring Clinical Meeting
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Forward Looking Statements
2
Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-
looking statements within the meaning of applicable U.S. securities law. These forward-looking statements or information include, but are not limited to statements or
information with respect to the projected worth of the lupus nephritis (LN) market, that voclosporin is potentially a best-in-class calcineurin-inhibitor (CNI) with robust
intellectual property exclusivity and the likelihood of data exclusivity in major markets, the expectation that voclosporin will be the only CNI with a label for LN, the
expected progress of the AURION study; the anticipated commercial potential of voclosporin for the treatment of LN; and anticipated interactions with the US Food and
Drug Administration. When used in these marketing materials, the words “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”,
“objectives”, “may” and other similar words and expressions, identify forward-looking statements or information.
We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the
market value for the LN program; that another company will not create a substantial competitive product for Aurinia’s LN business without violating Aurinia’s
intellectual property rights; and the size of the LN market. Even though the management of Aurinia believes that the assumptions made and the expectations
represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary
materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: the
market for the LN business may not be as estimated; and competitors may arise with similar products.
Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking
statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or
intended. Also many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as
actual results and future events could differ materially from those anticipated in such statements. Accordingly you should not place undue reliance on forward-looking
statements or information.
Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this presentation is qualified by this
cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in
Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval
(SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at
www.sec.gov/edgar.
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Guest Speakers & Disclosures
3
Samir Parikh, MD: Assistant Professor of Clinical Nephrology at the Ohio State University; Fellow of American Society of Nephrology (ASN)Research grant, Clinical Investigator
Michael Bubb, MD: Associate Professor of Medicine, Rheumatology and Clinical Immunology at the University of FloridaConsultant for Aurinia
Gabrielle Davis: Former News Journalist turned Patient AdvocateConsultant for Aurinia
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Agenda
4
Welcome Celia Economides, Head of IR, Aurinia
Living with LN Gabrielle Davis, Patient Advocate
Overview of Voclosporin Robert Huizinga, VP, Clinical Affairs, Aurinia
AURA 48-week Results Samir Parikh, MD, Assistant Professor of Clinical Nephrology, the Ohio State University
Panel Discussion/Q&A Moderator: Simrat Randhawa, Head of Medical Affairs, AuriniaRichard Glickman, CEO, AuriniaGabrielle Davis, Patient AdvocateMichael Bubb, MD, Associate Professor of Medicine, Rheumatology & Clinical Immunology, University of FloridaSamir Parikh. MD, Assistant Professor of Clinical Nephrology, the Ohio State University
Closing Remarks Richard Glickman, CEO, Aurinia
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Overview of Voclosporin
Robert Huizinga, Vice President, Clinical Affairs, Aurinia
5
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Voclosporin: A Novel Calcineurin Inhibitor Providing Significant Clinical Differentiation
Voclosporin has a modified functional group on amino acid 1 which allows the molecule to offer several advantages over legacy CNI’s
*Legacy CNI’s (cyclosporine & tacrolimus) are not approved for Lupus Nephritis in the EU/US
Altered functional group on CsA
Voclosporin
Impacts binding to the latch region on
calcineurinModification results in:
1) Predictable PK/PD relationship
2) Increased potency 3-4 fold (vs. CSA)
3) Altered metabolic profile and faster elimination of resultant metabolites
Clinical benefits*:
• Allows for flat dosing • Improved lipid profile (vs. CSA)
• Reduced risk of diabetes (vs. TAC)
• No impact on MPA levels when used in combination (vs. CsA)
N
HO
O
HN
N
OO
N
O
N
O
N O
NH
O
HN
O
N
O
HN
O
N
O
6
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Binding to Calcineurin Occurs Through the Latch Region of Voclosporin
Calcineurin
Voclosporin
Latch region
Kuglstatter A, et al. Acta Crystallogr D Biol Crystallogr. 2011;67(Pt 2):119-123.
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Synergistic Impact of Calcineurin Inhibition in LN
APC, antigen-presenting cell; IL, interleukin; INF, interferon; LN, lupus nephritis; NFAT, nuclear factor of activated T-cells; TNF, tumor necrosis factor.1. Mak A, Kow NY. J Immunol Res. 2014;2014:419029. doi:10.1155/2014/419029.2. Cooper JE, et al. Clin Nephrol. 2010;73(5):333-343.3. Zhang B, Shi W. Int J Nephrol. 2012;2012:809456. 4. Wang Y, et al. J Am Soc Nephrol. 2010;21(10):1657-1666.5. Faul C. et al. Nat Med. 2008;14(9):931-938.
Voclosporin has a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to SoC (MMF)
By inhibiting calcineurin, voclosporin blocks IL-2 expression and T cell–mediated immune responses1,2
CNI’s have shown an ability to stabilize podocytes in the kidney, which protects
against podocytopathy and proteinuria3-5
Cytoplasm
T cell
receptor
APC
Nucleus
IL-2
INF-gamma
TNF-alphaCell-mediated
immune
response
Voclosporin
Voclosporin
Actin
cytoskeleton Dephosphorylated
synaptopodin
breaks up and
destabilizes the
actin cytoskeleton
of the podocyte
Glomerular basement membrane
Synaptopodin
Stabilization of the actin cytoskeleton within the podocyte via calcineurin inhibition has the potential to be disease
modifying in LN
Tissue
damage
8
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Voclosporin - Key Benefits 1,2,3
1. Aurinia Data on file2. Busque S, et al. Am J Transplant. 2011;11(12):2675-2684 & AURA LV Data
3. AURA-LV Data on file
Voclosporin
Increased Potency vs. cyclosporine A,
allowing lower dosing
requirements 1
Limited inter & intra patient variability –
allowing flat dosing 1,3
Limited incidence of glucose intolerance
& diabetes at targeted doses vs.
tacrolimus 2
Less cholesterolemia than cyclosporine A 1
0 2 4 6 80
100
200
300
400
500
600
Time (h)
Co
nce
ntr
atio
n (
ng/
mL)
VCSCsA
4.5
5.0
5.5
6.0
6.5
–10 0 10 20 30 40 50 60 70 80
Week
Drug therapy ends
Total Cholesterol (Study Isa05-25)Mean ±95% CI
VCS
CsA
0
5
10
15
20
Cas
es o
f n
ew o
nse
t d
iab
etes
(12
mo
nth
s)
Low conc. Mid conc.Voclosporin Tacrolimus
Mea
n t
ota
l ch
ole
ster
ol
9
Concentration (ng/mL)
0 10 20 30 40 50 600
10
20
30
40
50
60
70
80
90
100
r = 0.5
%C
NI
Concentration (ng/mL)0 250 500 750 1,000 1,250 1,500
0
25
50
75
100
%C
NI
r = 0.7
Concentration (ng/mL)
0 100 200 300 400 500 600 700 800 900
0
25
50
75
100
r = 0.8
%C
NI
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AURA-LV (AURA) 48-week data in Lupus Nephritis
Samir Parikh, MD, the Ohio State University
10
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SLE & LN Overview & Symptomatology
11
1. Lupus Foundation of America website: http://www.lupus.org/about/statistics-on-lupus
2. NIDDK, Lupus Nephritis. https://www.niddk.nih.gov/health-information/health-topics/kidney-disease/lupus-nephritis/Pages/index.aspx. Accessed July 26, 2016.
3. Maroz N, Segal MS. Am J Med Sci. 2013;346(4):319-23. 4. Lupus Foundation of America, http://www.lupus.org/resources/15-questions-
kidney-issues-and-lupus1. Accessed July 26, 2016.
CENTRAL NERVOUS SYSTEM
Headaches, dizziness, memory disturbances,
vision problems, seizures, stroke,
or changes in behavior
LUNGS
Pleuritis, inflammation, or pneumonia
BLOOD
Anemia, decreased white cells, increased risk of
blood clots
HEART
Chest pains, heart murmurs
KIDNEYS
Inflammation
SLE is a chronic, complex and often disabling autoimmune disorder
Affects over 500K people in the US (mostly women)1
Highly heterogeneous, affecting range of organ &
tissue systems1
LN is an inflammation of the kidneys caused by SLE & represents a serious progression of SLE
Up to 60% of SLE patients develop LN2
Straightforward disease outcomes—early response correlates w/long term outcomes; measured by proteinuria2
Debilitating and costly, often leading to ESRD, dialysis, renal transplant, and death2
Severe LN progresses to ESRD within 15 years of diagnosis in 10% to 30% of patients3
Leakage of blood proteins into the urine (proteinuria) is clinical sign of LN4
NO FDA OR EMA APPROVED LN THERAPIES
Widespread
fatigue, fever, joint pain, muscle aches,
photosensitivity, rashes, hair loss, oral ulcers, anxiety & depression
!
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The Severity of Lupus Nephritis
12
Mok et al, Arthritis Rheum 2013
Standardized
mortality ratio
SLE patients w/renal damage and ESRD have 14-fold and >60-fold increased risk, of premature death, respectively
12
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Early Clinical Response is Critical to Maintaining Long-Term Kidney Health in LN
13
8%
57%
87%
0%
20%
40%
60%
80%
100%
120%
Complete Remission Partial Remission No Response
LN patient survival without ESRD based on treatment response1
Not on Dialysis @ 10 years On Dialysis at 10 years
92%
43%
13%
1. Chen YE, et al. Clin J Am Soc Nephrol. 2008;3(1):46-53. Response = 50% reduction in proteinuria; Remission = proteinuria <.33 g/24 hrs..
% o
f P
atie
nts
Rapid control & reduction of proteinuria in lupus patients may show a reduction in the need for dialysis1
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STANDARD THERAPY for PROLIFERATIVE LN
IV Cyclophosphamide 0.5-1g/m2 Monthly for 6 months
Proliferative LN: Give IV Methylprednisolone 0.5-1g/d for 1-3 days followed byOral Prednisone 1mg/kg/d ideal body weight, Maximum 80 mg/d, Taper Over Weeks
PLUS:
Oral MMF 2-3g/d for 6 months
PO Cyclophosphamide 1-1.5mg/kg/d, maximum 150 mg/d for 2-4 months
IV Cyclophosphamide 500 mg every 2 weeks for 3 months: LOW-DOSE-EURO-LUPUS REGIMEN
Or OrOr
24 week Partial Response & Complete Remission
Rates with Cyclophosphamide and MMF2
0%
10%
20%
30%
40%
50%
60%
Partial Response Complete Remission
Cyclophosphamide MMF
9%
53%56%
% o
f P
atie
nts
8%
*
Results of the Aspreva Lupus Management Study (ALMS) showed that the majority of patients failed to achieve CR at 24 weeks for both of these first-line therapeutics2
A better solution is needed to improve renal response rates for LN
1. Hahn BH, et al. Arthritis Care Res (Hoboken). 2012;64(6):797-808.2. Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112
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Drug Class Target Clinical Trial Status
Abatacept-BMS CTLA4-Ig CTLA4-B7 Phase 3- FAILED
Abatacept-ACCESS CTLA4-Ig CTLA4-B7 Phase 2- FAILED
Laquinamod Small Molecule Inflammation Phase 2- ENCOURAGING
Rituximab Monoclonal Antibody CD20 Phase 3- FAILED
Ocrelizumab Monoclonal Antibody CD20 Phase 3 - STOPPED
Sirukumab Monoclonal Antibody IL-6 Phase 2-FAILED
Bortezomib Proteasome Inhibitor Plasma Cells Phase 4- STOPPED
Anti-CD40 Ligand Monoclonal Antibody CD40 Ligand Phase 2- STOPPED
Tabalumab Monoclonal Antibody BLyS Phase 3- FAILED
Anti-TWEAK Monoclonal Antibody TWEAK Phase 2- FAILED
Recently Completed Clinical Trials in LN
Parikh et al JASN 2016
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CNIs as Part of a Multi-Target Initial Treatment Regimen
Liu et al, Ann Int Med, 2015
LN IV MP 500mg/d X3d Oral Steroid Taper 0.6mg/kg/d
IV Pulse CYC 0.75g/m2MMF 1g/d+TAC 4mg/d
Complete Renal Remission
N=368
P < 0.001
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AURA Study Design: Phase IIB
17
Study was designed to evaluate whether voclosporin added to SoCcan increase speed of remission & overall remission rates
in the presence of extremely low steroids
VOCLOSPORIN 23.7 mg bid VOCLOSPORIN 23.7 mg bid
MMF 2 g + oral corticosteroids
VOCLOSPORIN 39.5 mg bid VOCLOSPORIN 39.5 mg bid
MMF 2 g + oral corticosteroids
PLACEBO PLACEBO
MMF 2 g + oral corticosteroids
Secondary endpoint
48 weeks
Primary endpoint
24 weeks
1:1
Ran
do
miz
ati
on
N=
26
5
20-25 mg/daily
15-20 mg/daily
10-15 mg/daily
5 mg/daily
2.5 mg/daily
Week 2 4 6 12 24 48
AURA - forced steroid taper
8
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AURA Key Inclusion Criteria & Outcome Measures
Indicative of highly active disease
KEY INCLUSION CRITERIA
Diagnosis of SLE according to ACR criteria
Biopsy proven LN [Class III, IV or Class V (alone or in combination w/Class III or
IV)]
Proteinuria of ≥1.5 mg/mgOR ≥2 mg/mg*
PRIMARY OUTCOME MEASURES
CR is defined as: Confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg
Normal, stable renal function (≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%)
The proportion of subjects achieving complete remission (CR) at 24 weeks
KEY SECONDARY OUTCOMES
Partial Remission, Time to Remission, Time to Partial Remission, Durability of remission and extra-renal activity (SLEDAI) at 24 & 48 weeks
+
*≥2 mg/mg refers to Class V patients
Presence of sustained, low dose steroids (≤10mg prednisone from week 16-24)
No administration of rescue medications
18
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AURA: Baseline Demographics
1919
Baseline Demographics ControlN=88
VCS 23.7mg BIDN=89
VCS 39.5mg BIDN=88
TotalN=265
Age (years) n 88 89 88 265
Mean ± SD 33.1 ± 10.0 31.4 ± 11.8 30.6 ± 9.6 31.7 ±10.5
Sex n (%)
Female 73 (83.0) 76 (85.4) 81 (92.0) 230 (86.8)
Race n (%)
White 42 (47.7) 30 (33.7) 36 (40.9) 108 (40.8)
Black 5 (5.7) 3 (3.4) 6 (6.8) 14 (5.3)
Asian (Indian sub-continent)
18 (20.5) 22 (24.7) 20 (22.7) 60 (22.6)
Asian (Other) 18 (20.5) 30 (33.7) 24 (27.3) 72 (27.2)
Other 5 (5.7) 4 (4.5) 2 (2.3) 11 (4.2)
Hispanic n (%)
Hispanic or Latino 13 (14.8) 9 (10.1) 13 (14.8) 35 (13.2)
Not Hispanic or Latino 75 (85.2) 80 (89.9) 75 (85.2) 230 (86.8)
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Baseline Clinical Characteristics ControlN = 88
VCS 23.7 mg BIDN=89
VCS 39.5 mg BIDN=88
TotalN = 265
Biopsy Class n (%)
Pure Class V 13 (15.0) 12 (13.5) 14 (15.9) 39 (14.7)
Non Class V (Class III, IV) 75 (85.0) 77 (86.5) 74 (84.1) 226 (85.3)
Baseline eGFR CKD-EPI (mL/min/1.73m²)
Mean ± SD 100 ±26.9 95 ±28.4 105 ±27.5 100 ± 27.8
Median 100 95 109 101
Min/Max 49, 153 41, 148 42, 165 41, 165
Baseline uPCR (mg/mg)
Mean ±SD 4.4 ± 3.58 5.2 ± 4.15 4.5 ± 3.03 4.7 ± 3.62
Median 3.1 3.8 3.7 3.5
Min/Max 0.8, 19.3 0.8, 29.7 1.0, 17.4 0.8, 29.7
AURA: Baseline Clinical Characteristics
20
20
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AURA: Renal Response (Remission) Rates at 24 & 48 weeks
Endpoint Treatment24
weeksOdds ratio
(95% CI)P-value*
48 weeks
Odds Ratio(95% CI)
P-value*
CompleteRemission
(CR)
23.7mg VCS BID 32.6% 2.03 (1.01, 4.05) p=.045 49.4% 3.21 (1.68, 6.13) p<.001
39.5mg VCS BID 27.3% 1.59 (0.78, 3.27) p=.204 39.8% 2.10 (1.09, 4.02) p=.026
Control 19.3% NA NA 23.9% NA NA
Partial Remission
(PR)
23.7mg VCS BID 70% 2.33 (1.68, 6.13) p=.007 68% 2.34 (1.27, 4.33) p=.007
39.5mg VCS BID 66% 2.03 (1.10, 3.76) p=.024 72% 2.68 (1.43, 5.02) p=.002
Control 49% NA NA 48% NA NA
21
*p-values are vs control group
First global trial in active LN to meet its primary endpoint
www.auriniapharma.com 22
23.7mg BID VCS demonstrates statistically significant CR & PR rates at 24 & 48 weeks
AURA: Improved CR & PR Over Time with Voclosporin
0%
10%
20%
30%
40%
50%
60%
Pat
ien
ts a
chie
vin
g C
R
Progression to Complete Remission
Control VCS 23.7mg BID VCS 39.5mg BID
p=.045
p<.001
0%
10%
20%
30%
40%
50%
60%
70%
80%
Baseline 24 weeks 48 weeks
Progression to Partial Remission
Control VCS 23.7mg BID VCS 39.5mg BID
p=.007
p=.007
p=.026
p=.002
p=.024
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AURA: Speed of Remission
23
P-Value <0.001 for both LD-VCS and HD-VCS
A statistically significant faster time to CR & PR compared to the control group
www.auriniapharma.com24
AURA Pre-specified Analysis: UPCR (mg/mg) (Mean ± SD) Over Time
0
1
2
3
4
5
6
7
8
9
10
Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48 Week 50
UP
CR
(m
g/m
g)
Visit
UPCR (Mean ± SD) Over Time
p=.009
p<.001
www.auriniapharma.com25
AURA: Mean Change from Baseline in SELENA-SLEDAI Score 24 & 48 weeks
-4.5
-5.3
-6.3
-7.9
-7.1
-8.3
Mean Change from Baseline in SELENA-SLEDAI Score
Control Voclosporin 23.7 mg BID Voclosporin 39.5 mg BID
p=.003
p=.003
p=.003p<.001
A statistically significant improvement in reduction of SLEDAI score vs. baseline in both VCS arms vs. patients in the control group
Mean Change from Baseline at 24 weeks Mean Change from Baseline at 48 weeks
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AURA Pre-specified Analysis:Ds-DNA Antibody (Mean ± SD) Over Time
26
1.75
21.75
41.75
61.75
81.75
101.75
121.75
141.75
161.75
181.75
Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48
dsD
NA
An
tib
od
y (I
U/m
L)
Visit
Anti-dsDNA (Mean ± SD) Over Time
p=.006
p=.01
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Safety
28
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AURA: Summary of TEAEs & Historical Comparison
29
1.Furie R. et al., Arthritis and Rheumatology, Vol. 66, No 2, February 2014
2. Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112 – Aspreva Lupus Management Study (Induction)3.Mysler, E. et al., Arthritis and Rheumatism, Vol. 65, No 9, September 2013, 2368-2379
4. AURA-LV Study results – Aurinia data on file
Treatment Emergent Adverse Events(TEAE)*
*includes TEAES following treatment period
ControlN = 88n (%)
VCS 23.7 mg BID N = 89n (%)
VCS 39.5 mg BIDN = 88n (%)
Any TEAE 78 (88.6) 82 (92.1) 85 (96.6)
Any Serious TEAE 17 (19.3) 25 (28.1) 22 (25.0)
Any TEAE with Outcome of Death 4 (4.5) 10 (11.2) 2 (2.3)
Any Treatment-Related TEAE 15 (17.0) 45 (50.6) 55 (62.5)
Any Serious Treatment-Related TEAE 1 (1.1) 4 (4.5) 7 (8.0)
AURA-LV4
N=265(to Dec 18th/16)
ALMS Induction2
N=364Abatacept Study1
MMF N = 298Ocrelizumab Study3
N=378
SAE’s, Subjects, n (%) 59 (22.3%) (25.3%) 92 (30.9%) 107 (28.3%)
Serious Infections, Subjects n (%)
29 (10.9%) (10.9%) 58 (19.5%) 64 (16.9%)
Deaths, Subjects, n (%) 13 (4.9%) 14 (3.8%) 14 (4.7%) 14 (3.7%)
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Renal Function: eGFR (mL/min/1.73m²) over time
30
Renal function remains stable throughout treatment period; eGFR returns to baseline after 48 weeks
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AURA: Blood Pressure (BP) (Mean ± SD) over 48 weeks
31
80
90
100
110
120
130
140
150
160
Baseline Day 1 Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24
Syst
olic
Blo
od
Pre
ssu
re (
mm
Hg)
Visit
Systolic BP (Mean ± SD) Over Time
Week 48
50
60
70
80
90
100
110
Baseline Day 1 Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48
Dia
sto
lic B
loo
d P
ress
ure
(m
mH
g)
Visit
Diastolic BP (Mean ± SD) Over Time
No significant difference in blood pressure over the 48-week treatment period
www.auriniapharma.com 32
ControlN = 88n (%)
VCS 23.7 mg BID N = 89n (%)
VCS 39.5 mg BIDN = 88n (%)
Diarrhea 14 (15.9) 16 (18.0) 14 (15.9)
Nausea 7 (8.0) 16 (18.0) 11 (12.5)
Cough 3 (3.4) 16 (18.0) 5 (5.7)
Vomiting 10 (11.4) 15 (16.9) 9 (10.2)
Anemia 7 (8.0) 13 (14.6) 14 (15.9)
Upper respiratory tract infection 14 (15.9) 12 (13.5) 18 (20.5)
Urinary tract infection 5 (5.7) 8 (9.0) 6 (6.8)
Pneumonia 2 (2.3) 7 (7.9) 7 (8.0)
Pyrexia 1 (1.1) 6 (6.7) 10 (11.4)
Dyslipidemia 6 (6.8) 6 (6.7) 7 (8.0)
Edema 1 (1.1) 2 (2.2) 5 (5.7)
Leukopenia 6 (6.8) 1 (1.1) 3 (3.4)
AURA: Key Adverse Events
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AURA: Safety Summary
33
1 Furie R. et al., Arthritis and Rheumatology, Vol. 66, No 2, February 2014
2 Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112 – Aspreva Lupus Management Study (Induction)3.Mysler, E. et al., Arthritis and Rheumatixm, Vol. 65, No 9, September 2013, 2368-2379
The overall safety profile is consistent with other immunomodulators
No new safety signals were observed with the use of voclosporin in LN patients; voclosporin was well-tolerated
In previous studies (other indications), >2000 patients have been treated with voclosporin with no abnormal or unexpected SAE’s—this remains the case upon review of the AURA data
Safety beyond 24 weeks Control N = 88n (%)
VCS23.7 mg BID
N = 89 (n (%)
Any Serious Adverse Event 1 (1.1) 2 (2.2)
Malignancies 1 (1.1)^ 0 (0)
Deaths 3 (3.4)* 0 (0)
^Malignancy (metastatic melanoma) occurred following treatment period*3 deaths occurred following the treatment period (after week 50)
13 deaths have been reported in the AURA study: pattern is consistent with other global Active LN
studies1,2,3
11 of 13 deaths occurred at sites with compromised access to SoC; patients who died had a statistically different clinical baseline picture, demonstrating a
more severe form of LN, potential comorbid conditions & poor nutrition
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AURA: CONCLUSIONS
First therapeutic agent to meet ALL KEY 24 & 48 week pre-specified secondary endpoints in global clinical trial for active LN.
VCS 23.7mg BID dose demonstrated a statistically significantly higher CR at both weeks 24 & 48 vs. patients in the control group (p=.045); (p<.001).
VCS 23.7mg BID achieved all secondary endpoints evaluated to date including time to remission/response and statistically significant reduction in UPCR and SLEDAI at 24 & 48 weeks.
This multi-target approach allowed for clinical response to be achieved using a Steroid-reduced protocol
Adverse events were more common in the VCS-treated groups but SAEs were similar to other LN trials.
These findings suggest that Voclosporin in addition to SOC may lead to improved outcomes in a multi-ethnic, multi-racial LN Population. A global placebo-controlled Phase III trial for voclosporin 23.7mg BID is scheduled to begin imminently
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Principal Investigators
Ihar AdzerikhkoElena MikhailovaNatalya MitkovskayaSergey PimanovNikolay Soroka
Boris Iliev BogovBoriana DeliyskaValentin IkonomovEduard Tilkiyan
Ruth AlmeidaFernando JimenezFaud TeranIrma TchokhonelidzeNino Tsiskarishvili
Maynor Herrera MendezNilmo Noel Chavez Perez
Shue-Fen LuoTien-Tsai Cheng
Arturo Reyes LoaezaSergio Ramon UrenaJuanita Romero DiazPablo Estaley SansonRodolfo Araiza CasillasMagdalena Rovalo
Stanislaw NiemczykAntoni SokalskiAndrezj WiecekMarian Klinger
Dragan JovanovicBranka MiticMilan RadovicGoran Radunovic
Patricia CarreiraFederico GonzalezXavier FulladosaEduardo Ucar
Brancha SatirapojKajohnsak Noppakun
Olga BugrovaTatiana ChenykhTatiana KamenevaLidia LysenkoTatiana RaskinaOlga ReshetkoNatalia VezikovaTatiana KropotinaAdelya MaksudovaVyacheslav MarasaevVladimir DobronravovIvan GordeevMikhail BatyushinVladimir RyasnyanskyAshot EssaianAlexey Frolov
Iryna DudarOlga GodlevskaSvitlana KorneyevaViktoriia VasyletsNataliya SydorMykola Kolesnyk
Samir ParikhNancy OlsenEllen GinzlerJames TumlinAmit SaxenaRamesh SaxenaRichard LafayetteWilliam Pendergraft IIIAmber PodollMichael BubbJennifer GrossmanAlejandro I OportaAlireza Nami
Shamila De SilvaChula HerathAnura HewageeganaAbdul Latiff Mohamed NazarA.W.M Wazil
Mujibur RahmanSyed Atiqul Haq
Tak Mao Daniel Chan Mo Yin Mok
Harold Michael P. GomezJoseph AntiguaBernadette Heizel ReyesLlewellyn T. HaoLinda Charmaine RobertoEric AmanteSandra NavarraAllan Lanzon
Jung-Yoon ChoeTae Young KangYon Su KimSeung-Geun LeeJi Soo Lee
Jason Choo Chon JunArchana Vasudevan
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ACKNOWLEDGEMENTS
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Panel Discussion/Q&A
Moderated by Simrat Randhawa, Head of Medical Affairs, Aurinia
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Thank You
ceconomidas@auriniapharma.com
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