Corporate Presentation - January 2022 2022 VERA THERAPEUTICS, INC - Investor Relations | Vera Therapeutics
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Corporate Presentation
C
January 2022
C
© 2022 VERA THERAPEUTICS, INC.
Forward Looking Statements
Disclaimer
This material has been made available to you with the consent of Vera Therapeutics, Inc. ("we", "us", "our", or the "Company"). Statements in this presentation that are not statements of historical
fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding our research and clinical development plans, the scope, progress, results
and costs of developing our product candidate or any other future product candidates, expected manufacturing capabilities, strategy, regulatory matters, including the timing and likelihood of
success of obtaining drug approvals, market size and opportunity and our ability to complete certain milestones. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,”
“goal,” “project,” “estimate,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these
identifying words. These forward-looking statements are based on the beliefs of the Company’s management as well as assumptions made by and information currently available to the Company.
Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive
risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing products and technologies and acquiring or in-licensing products
and technologies, future results from the Company’s ongoing and planned clinical trials, the Company’s ability to obtain adequate financing to fund its planned clinical trials and other expenses,
trends in the industry, the legal and regulatory framework for the industry and future expenditures and other risks disclosed in the Company’s filings with the Securities and Exchange Commission.
In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the
variations may be material. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the
assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. You are cautioned not to
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This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is
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The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.
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© 2022 VERA THERAPEUTICS, INC.
Vera Company Highlights
Experienced team with track record of clinical, commercial, and corporate development success
building a leading biotechnology company to change standard of care for immunologic diseases
Lead clinical-stage asset, atacicept, is a potential disease-modifying agent that targets B-cells and
plasma cells, the source of autoimmunity
Phase 2b program in IgA Nephropathy (IgAN), clinical data in hand show best-in-disease potential
Additional autoimmune indications increase blockbuster potential, including lupus nephritis
In-licensed late-stage clinical anti-BKV mAb with encouraging data and estimated $1B unserved
worldwide commercial opportunity
Strong financial profile, $135M gross proceeds raised in the last 12 months and access to a $50M
credit facility which management believes to be sufficient to fund operations to Q4 2023
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© 2022 VERA THERAPEUTICS, INC.
Experienced Team with Successful Clinical and Commercial Track Record
Marshall Fordyce, M.D. Celia Lin, M.D. Sean Grant, MBA
President and CEO Chief Medical Officer Chief Financial Officer
• >15 years drug development • >9 years drug development in Clinical • >15 years in corporate strategy,
leadership Development and Medical Affairs at finance, and capital raising
• Former Gilead, 7 new drug approvals, Genentech and Amgen • Former healthcare banker with capital
Project Lead for tenofovir alafenamide • Led Ph3 global trial execution in raising and M&A success
program various therapeutics areas
Joanne Curley, PhD Lauren Frenz, MBA Joe Young, CPA, MBA
Chief Development Officer Chief Business Officer Chief Accounting Officer
• >20 years drug development, former • 15 years industry experience, including • Leader of accounting & finance
VP Gilead project and portfolio global commercial planning and multiple operations for public and private
management blockbuster launches at Gilead biotech companies, >20 years
• Strategic advisory at SVB Leerink Marshall Fordyce, M.D.
• Big 4 audit background
President and CEO
Tom Doan Tad Thomas, PhD Board and Investors
SVP, Clinical Operations SVP Manufacturing
• >20 years of clinical operations
• > 20 years CMC experience including
experience
tech transfer and managing contract
• Former Clinical Operations
manufacturing organizations
Therapeutic Area Head of
• Strong biologics background
Inflammation at Gilead
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© 2022 VERA THERAPEUTICS, INC.
Vera’s Financial Position
Current capital
~$135M ~$86.2M $50M position
Gross proceeds raised Credit facility expected to be
Cash and cash
in the last 12 months available at sufficient to
equivalents
including May IPO
NASDAQ: VERA
(As of 9.30.21) Vera’s option
Q4 2023
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© 2022 VERA THERAPEUTICS, INC.
Strategic Vision: Develop Transformative Therapeutics for Immunologic Diseases
• Lead indications with large markets and validating clinical data
• Vera has worldwide, exclusive licenses to develop and commercialize atacicept from Merck KGaA and MAU868 from Pfizer/Novartis
• Experienced corporate development team with a strategic focus to develop and commercialize novel therapies for immunologic diseases
Atacicept New Asset MAU868
IgA Nephropathy Lupus Nephritis Additional Autoimmune BK Virus
(IgAN) (LN) Indications Nephropathy
• Positive Phase 2a results • Phase 2 results in SLE show • Dual inhibition of BLyS and • Late-stage clinical asset for
clinical efficacy in severe APRIL reduces disease- BK viral disease
• Conducting Phase 2b trial,
patients associated antibodies with
primary endpoint data • No currently FDA approved
dose-dependence
expected Q4 2022 • LN trial Ph2 or Ph3, with therapies
FDA feedback expected in • Potential for best-in-class
• Phase 2 results expected
Q4 2021 for B-cell targeting biologics
mid-2022
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© 2022 VERA THERAPEUTICS, INC.
Vera Is Well-Positioned to Develop and Commercialize MAU868
Pipeline Development Execution Committed to the Development of MAU868
BK Virus
Nephropathy
Team with proven track record in antiviral
development and commercialization
• Leading cause of kidney transplant failure,
leading to high morbidity and healthcare cost Development leadership maintained –
• No available BK virus-specific treatments Ciara Kennedy (former CEO of Amplyx),
brought MAU868 through Phase 2, now
• MAU868: late-stage clinical asset with serves as Senior Advisor of Vera
encouraging data
Clinical and commercial synergy with
• MAU868 poised to change the standard of
Vera’s nephrology focus
care, consistent with Vera’s mission
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© 2022 VERA THERAPEUTICS, INC.
MAU868 Adds Another Late-Stage Program to the Pro-Forma Pipeline…
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© 2022 VERA THERAPEUTICS, INC.
…While Bolstering News Flow and Clinical Data
ORIGIN ORIGIN
IgAN Phase 2b IgAN Phase 2b
Fully enrolled Week 24 results
(Mid-2022) (Q4 2022)
Multiple significant
catalysts expected 2022
in near-term
LN Phase 2 or 3 MAU868 Phase 2
Publicly Announce Plans Cohorts 1 and 2 full results
(Q1 2022) (Mid-2022)
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© 2022 VERA THERAPEUTICS, INC.
Atacicept for IgAN
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© 2021
2022 VERA THERAPEUTICS, INC.IgA Nephropathy (IgAN): Multi-Billion Dollar Market Opportunity
~$4-8 B Market Opportunity in US for Novel IgAN
Therapeutics2
IgAN is a serious and progressive autoimmune disease
of the kidney; most diagnoses occur in patients of 20s- Prevalence
~126K
30s, severely impacting QoL
High-Risk
>1g/L proteinuria
~60K
Orphan Disease indication in the US and EU1
~40K
Addressable
Up to 50% of IgAN patients progress to end-stage renal
disease, resulting in need for dialysis or a transplant
• Significant market opportunity ex-US
• Higher incidence rates in Japan
11 1Orphan Disease Designation not yet obtained for atacicept in IgAN. 2ClearView Healthcare Partners Analysis.
© 2022 VERA THERAPEUTICS, INC.Current Standard of Care Is Suboptimal
Current Standard of Care
Corticosteroids
ACE inhibitors, ARBs +/– (systemic)
• Blood pressure control • Immunosuppressive therapies used in severe cases
• ACEi and ARB • Systemic steroids used, but high dropout rate in
• Limited clinical benefit randomized controlled trials due to well-known
acute + chronic steroid side effects1,2
Standard of care poised for a disease-modifying biologic aiming to replace steroid use
12 1,2 Lv J. et al. JAMA 2017. Manno C. et al. Nephrol Dial Transplant 2009.
© 2022 VERA THERAPEUTICS, INC.Atacicept is a Dual Inhibitor (BLyS and APRIL) of Plasma Cells and B Cells
Key Considerations
• Fully humanized fusion protein,
subcutaneously administered
• Blocking BLyS alone works for SLE and LN, but
may not be potent enough for IgAN
• Dual blockade by TACI-Ig shown to be more
potent than blocking BLyS alone1 and has
benefit of targeting long-lived plasma cells2, in
addition to B cells, thus reducing
autoantibody production3
13 1Haselmayer P et al. Eur J Immunol 2017;00:1–11. 2Hiepe F et al. Nat Rev Rheumatol 2011;3:170-178. 3Gordon et al. 2017 Arthritis & Rheumatology 69(1): 122-130.
© 2022 VERA THERAPEUTICS, INC.Atacicept Targets Immune Complex Formation, Upstream In IgAN Pathogenesis
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© 2022 VERA THERAPEUTICS, INC.Galactose-deficient IgA1 (Gd-IgA1) Plays a Central Role In IgAN Pathogenesis
Source of autoantibodies is the hinge region of Gd-IgA1
Hinge Region IgA1 Dimer
Gd-IgA1 and autoantibodies (IgA, IgG) represent disease-modifying targets for IgAN
15 Lai et al. Nature Reviews 2016.
© 2022 VERA THERAPEUTICS, INC.High Gd-IgA1 Associated With Reduced Time to Dialysis, Transplant, and Death
• High Gd-IgA1 (Group 4) is associated with
increased risk of ESRD and death1
• Serum level of glycan-specific IgG
antibodies is correlated with the level of
urinary protein excretion2 and the risk of
progression to ESRD or death3
16 1Zhao N et al. Kidney Int 2012. 2Suzuki et al. JCI 2009. 3Berthoux F et al. J Am Soc Nephrol 2012.
© 2022 VERA THERAPEUTICS, INC.First Molecule to Significantly Reduce Gd-IgA1 (60%) In IgAN Patients
Placebo (n=4) Atacicept 25mg (n=4) Atacicept 75mg (n=4) Atacicept 150mg
0
0%
-10
Mean % change in Gd-IgA1
-20
Currently in
-25% Ph 2b study1
-30
-40
-50
-60
-60%
-70
17 Barratt et al. American Society of Nephrology 2020. 1150 mg not tested in Ph2a study; Results from Ph 2b study not yet available.
© 2022 VERA THERAPEUTICS, INC.Atacicept 75 mg Decreased Serum Gd-IgA1 Levels to the Lowest Risk Quartiles
Gd-IgA1 level (ng/ml) Quartile SUBJECT ALLOCATION Baseline WEEK 4 WEEK 12 WEEK 24 WEEK 48 WEEK 72
< 3.13 1ST 1 Placebo 4TH 4TH 4TH 4TH 4TH 4TH
3.13-5.01 2ND 2 Placebo 4TH 3RD 4TH 4TH 4TH 4TH
5.01-7.75 3RD 3 Placebo 2ND 2ND 2ND 2ND 3RD 3RD
> 7.75 4TH 4 Placebo 2ND 1ST 2ND 2ND 2ND
5 Placebo 4TH 3RD 4TH 4TH 4TH
Quartiles determined by
JANUS population
6 Atacicept 25mg 4TH 4TH 3RD 3RD 3RD 3RD
7 Atacicept 25mg 3RD 3RD 3RD 3RD 3RD 3RD
8 Atacicept 25mg 4TH 3RD 3RD 3RD
9 Atacicept 25mg 2ND 2ND
10 Atacicept 25mg 1ST 1ST 1ST 1ST
11 Atacicept 25mg 2ND 2ND 1ST 2ND 2ND 2ND
12 Atacicept 75mg 3RD 1ST 1ST 2ND 1ST
13 Atacicept 75mg 4TH 3RD 2ND 1ST 2ND 2ND
14 Atacicept 75mg 1ST 1ST 1ST 1ST 1ST 1ST
15 Atacicept 75mg 2ND 1ST 1ST 1ST 1ST
16 Atacicept 75mg 4TH 3RD 3RD 2ND
After 24 Weeks, all subjects receiving atacicept 75mg had reductions in serum Gd-IgA1 to the lowest risk quartiles
18 Barratt et al. American Society of Nephrology 2021.
© 2022 VERA THERAPEUTICS, INC.Phase 2a IgAN Trial (JANUS): Elected “Best Abstract”
Study Design
• Patients ≥18 years with IgAN
• Proteinuria (UPCR) 0.75 to 6
mg/mg
• Stable ACE inhibitor and/or
ARB ≥8 weeks
Interim safety review of ≥5 subjects/arm treated for ≥12 weeks;
interim efficacy review after 16 subjects treated for 24 weeks
Primary analysis at week 48 (1º endpoint: Safety)
Final analysis at end of study
19 Barratt et al. ERA EDTA 2020.
© 2022 VERA THERAPEUTICS, INC.Phase 2a IgAN Trial (JANUS): Shows Compelling Proof-of-Concept In IgAN
Change in Proteinuria by 24-hour UPCR at Week 241 Median % Change from Baseline2
IgA IgG IgM Gd-IgA1
20%
20
7%
10%
10 0%
0%
0
-10%
-10
-7% -10% -7%
-20%
-20 -13%
-30%
-30 -25%
-40%
-40 -31%
-38%
-50
-50%
-60
-60% -52%
-70
-70% -60%
-80
-80% -69%
Placebo (n=4) Atacicept 25mg (n=6) Atacicept 75mg (n=5)
Dose-dependent reduction in UPCR at week 24 Dose-dependent reduction in serum IgA, IgG, and IgM
Atacicept also Showed Stable GFR for >1 Year vs 25% decline in Placebo
First and only molecule to show 60% reduction in Gd-IgA1 in IgAN patients
20 1Phase 2a JANUS Trial CTR Table 13.3.3.21. 2Phase 2a JANUS Trial CTR Table 15.3.3.9.
© 2022 VERA THERAPEUTICS, INC.Phase 2a IgAN Trial (JANUS): Clear Dose-Dependent Reductions on Serum Igs
IgG IgA IgM
21 Phase 2a JANUS Trial CTR.
© 2022 VERA THERAPEUTICS, INC.Phase 2a IgAN Trial (JANUS): Dose-Dependent, Durable Gd-IgA1 Reduction
22 Phase 2a JANUS Trial CTR, Figure 15.3.3.39.
© 2022 VERA THERAPEUTICS, INC.Phase 2b IgAN Trial (ORIGIN): Powered for Proteinuria 1⁰ Endpoint
Patients ≥18 years with IgA nephropathy and high risk of disease progression
Double-Blind Treatment Open-label Extension (OLE) Safety FU
Placebo Total n=30 Atacicept 150mg
Atacicept 25mg Total n=15 Atacicept 150mg
Atacicept 75mg Total n=30 Atacicept 150mg
Atacicept 150mg Total n=30 Atacicept 150mg
UPCR Timepoints
eGFR Timepoints
week -4 0 24 36 96/ET 26
10 Endpoint 20 Endpoint
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© 2022 VERA THERAPEUTICS, INC.Well Characterized Safety Profile from Clinical Experience
A total of 1,414 subjects have received at least 1 dose of atacicept across different indications
including two large SLE studies and long-term extension studies.
Exposure-adjusted incidence rates (EAIRs) of serious infection and serious treatment emergent
adverse event rates were similar between atacicept and placebo
No association between risk of infection and magnitude of pharmacodynamic effects with atacicept
Clinical trials require standard risk mitigation including up-to-date vaccinations, eligibility review by
medical monitor, and education on early detection of signs/symptoms of infection
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© 2022 VERA THERAPEUTICS, INC.Demonstrated Tolerability Profile In an Integrated Safety Analysis of Over
1,000 Patients on Atacicept
Summary of adverse events (AEs) >5% in any arm, by dose in the double-blind placebo-controlled set
Atacicept
Placebo 25 mg 75 mg 150 mg All subjects
n=483 n=129 n=384 n=572 n=1568
Discontinuation due to AE 30 (11) 14 (28) 30 (13) 46 (16) 120 (14)
Serious AE 51 (11) 15 (12) 51 (13) 61 (11) 178 (11)
Severe AE 28 (6) 10 (8) 45 (12) 56 (10) 139 (9)
Infections 211 (44) 43 (33) 180 (47) 281 (49) 715 (46)
Serious infections 20 (4) 1 (1) 23 (6) 22 (4) 66 (4)
Hypersensitivity 37 (8) 8 (6) 40 (10) 55 (10) 140 (9)
Injection site reactions 54 (11) 27 (21) 109 (28) 156 (27) 346 (22)
Cardiac arrhythmias 18 (4) 11 (9) 23 (6) 25 (4) 77 (5)
Vestibular disorders 19 (4) 5 (4) 18 (5) 26 (5) 68 (4)
Adapted from Gordon et al. 2019. Integrated safety profile of atacicept: an analysis of pooled data from the atacicept clinical trial program. Rheumatology Advances in Practice; 0: 1-12.
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© 2022 VERA THERAPEUTICS, INC.We Believe Atacicept Has Best-in-Disease Potential In IgAN
Drug Tarpeyo Atrasentan BION-1301 Sparsentan Narsoplimab Teletacicept Atacicept
Market Cap1 ~$650M ~$890M ~$890M ~$2.0B ~$430M ~$4.0B ~$650M
Administration Oral (QD) Oral (QD) Intravenous (TBD) Oral (QD) Intravenous (Qwk) Subcutaneous (Qwk) Subcutaneous (Qwk)
Corticosteroid
ETaR/AT1R Complement Dual BLyS/APRIL Dual BLyS/APRIL
Mechanism (reformulated ETaR antagonism APRIL inhibition
antagonism inhibition (MASP-2) inhibition inhibition
Budesonide)
Current Stage of
Accelerated approval Phase 3 Phase 1/2 Phase 3 Phase 3 Phase 2 Phase 2b
Development
~60% reduction
~70% reduction from 61-72% in OL (wk 12 (240mg, p=0.005)8
Proteinuria 34% reduction (wk 28% reduction
N/A3 baseline (N=2, week 49.8% (week 36)5 and wks 31-54)6, no
Reduction 36)2 ~40% reduction (75 mg, week 24)
~50)4 reduction in RCT
(160mg)8
~70% reduction (n=2, 60% reduction
Gd-IgA1 Reduction N/A3 N/A3
450mg IV, week ~38)4
N/A3 Not reported7 Not reported7
(75 mg)
Well tolerated, no
no drop-outs (no
Safety ~20% drop-out2 N/A3
placebo) 4
N/A3 Not reported7 No drop-outs 8 drop-outs, comparable
to placebo
This data is based on a cross-trial comparison and not a head-to-head clinical trial, such data may not be directly comparable due to differences in study protocols, conditions and patient populations.
1Approximate FD Market Cap as of 01/04/2022 FactSet 2TARPEYO Package Insert. 3“N/A” indicates that these drugs were not evaluated in IgAN through a clinical trial. 4 Barratt et al. ASN Kidney Week 2021. 5Travere Press Release
26 8/16/2021 6Lafayette et al. Kidney Int Rep. 2020. 7“Not reported” indicates that the drug was evaluated in IgAN through a clinical trial, but the clinical data was not reported. 8 Lv et al. ASN Kidney Week 2021
© 2022 VERA THERAPEUTICS, INC.Dual APRIL/BLyS vs. APRIL-Only: Potential Advantages In Potency and Dosing
• Potency: Atacicept shows similar reduction in Gd-IgA1 at a lower dose than APRIL-only approaches
- For ~60% reduction in Gd-IgA1: atacicept 75mg SC qwk vs. BION-1301 450mg IV q2w
• Dosing: APRIL-only approach may require multiple larger volume injections
- Atacicept has well-defined therapeutic window from 25mg to 150mg as 1mL subcutaneous injection
- BION-1301 being explored as 600mg (150mg/mL), in two separate 2mL subcutaneous injections
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© 2022 VERA THERAPEUTICS, INC.Lupus Nephritis Expansion
Could Increase Atacicept’s
Blockbuster Potential
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© 2021
2022 VERA THERAPEUTICS, INC.Atacicept for Lupus Nephritis: Dual BLyS-APRIL Inhibition Shows Potential to
Outperform Approved BLyS-Only Drug
Pre-Clinical Evidence: Clinical Evidence: Two approved drugs in LN,
BLyS-APRIL >> BLyS or APRIL alone BLyS-APRIL >> BLyS alone room for improvement
100 Bone Marrow
CD138+ PC [thousands/ 2 femurs]
80
60
40
20
0
Controls mTACI-Fc mBAFFR-Fc ((Apry-1a-1))
In similar populations of patients with SLE, Significantly more patients with
*** p < 0.001 Anti-BLyS +
Anti-APRIL
Anti-BLyS Anti-APRIL BLyS-APRIL inhibition may provide better renal response on BENLYSTA vs Placebo,
clinical efficacy than inhibiting BLyS alone* overall RR stillAtacicept Phase 2 Trial Shows Evidence of Clinical Efficacy in SLE
SRI-6 Response1 Among HDA Patients in the HDA Patients Reaching LDA in the
Phase 2 ADDRESS II Trial Δ=26.1% Phase 2 ADDRESS II TRIAL Δ=23.8%
60 * (p=0.005) 40 * (pNew Clinical-Stage Asset:
MAU868, A Novel Monoclonal
Antibody Against BK Virus
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© 2021
2022 VERA THERAPEUTICS, INC.BK Virus Infection: Potential for a Blockbuster Market Opportunity
BK Virus (BKV) leads to significant morbidity and
Unserved Market ~$1B+ Commercial Opportunity WW in 20361
mortality in transplant patients
Kidney Transplants: ~80,000 RTx per year WW
Viruria (30-50%) 40,000 pts – measurable BKV
80-90% of healthy adults have been infected with BKV Viremia (10-20%) 15,000 pts – kidney at risk
and the virus remains latent in healthy adults
Nephropathy (3-4%) 3,200 pts – irreversible damage
Rejection (1-2%) 1,500 pts – kidney loss
BKV can be reactivated when a patient is
immunocompromised
HSCT Procedures: ~100,000 HSCT per year WW
Allogenic (50%) 50,000 pts – higher risk of BKV
BKV impacts two immunocompromised populations Viremia (10-35%) 22,500 pts – risk of cystitis
including kidney transplant patients and hematopoietic
Cystitis (6-16%) 10,500 pts – hemorrhagic cystitis
stem cell transplant (HSCT) recipients
• BKV Nephropathy is the leading cause of allograft loss
• BKV in HSCT patients have increased risk of severe hemorrhagic cystitis
No approved anti-BKV treatments in the United States
32 1 Back Bay Analysis.
© 2022 VERA THERAPEUTICS, INC.Kidney Transplants: BKV Nephropathy is a Leading Cause of Allograft Loss
There is a need in renal transplants for a BKV treatment option that could address escalating BKV infections early without risking
immune system allograft rejection.
Kidney Transplants: ~80,000 RTx per year WW Graft Survival in Kidney Transplant Patients
is Worse with BKV Nephropathy
Viruria (30-50%) 40,000 pts – measurable BKV
Viremia (10-20%) 15,000 pts – kidney at risk
Nephropathy (3-4%) 3,200 pts – irreversible damage
Patients with BKVN
Patients without BKVN
Rejection (1-2%) 1,500 pts – kidney loss
Vasudev, B et al. Kidney International 2005
• Poor Transplant Outcomes with BKV Reactivation
‒ BKV viremia is associated with reduction in renal function and allograft survival
‒ BKV nephropathy is associated with allograft loss
• Current Treatment for BKV in Renal Transplant: Reduce Immunosuppression Measures
‒ In response to BKV reactivation, physician will lower immunosuppression, with risk of allograft rejection
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© 2022 VERA THERAPEUTICS, INC.BKV in HSCT Patients: Increased Risk of Severe Hemorrhagic Cystitis
There is a need for therapy that directly addresses the underlying cause of viral hemorrhagic cystitis.
HSCT Procedures: ~100,000 HSCT per year WW Severe Hemorrhagic Cystitis
Patient Health Impact Current Care is Inadequate
Allogenic (50%) 50,000 pts – higher risk of BKV
Serious bleeding RBV transfusions; Bladder
due to hematuria embolization or cystectomy
Viremia (10-35%) 22,500 pts – risk of cystitis
Severe, prolonged
Cystitis (6-16%) 10,500 pts – hemorrhagic cystitis Narcotics
and intractable pain
Kidney dysfunction
• HSCT Patients are Highly Immunocompromised and failure
Dialysis
‒ Vulnerable to BKV reactivation
Life-disturbing
• BKV Reactivation may Lead to Hemorrhagic Cystitis Continued bladder irrigation
urinary symptoms
‒ Viral hemorrhagic cystitis is a source of significant complications
and risk of mortality
‒ Renal impairment can be severe Increased mortality none
‒ Currently managed via a range of supportive and invasive
modalities of therapy
34
© 2022 VERA THERAPEUTICS, INC.MAU868: First Known Neutralizing Antibody Targeting BK Virus (BKV)
Blocks BKV Virion Binding
Designed to disrupt cell surface binding and
to prevent cell entry and spread of infection
• Novel Target: mAB that neutralizes infection by
blocking BKV virion binding to host cells
• Active Against All Genotypes: Sub-nanomolar potency
against all major genotypes
• Proven Mechanism: Neutralization of virus infection
effective in other approved mAB therapies
• More Potent than IVIG: ~10,000 fold more potent
in vitro
35
© 2022 VERA THERAPEUTICS, INC.MAU868 Potently Neutralizes all BKV Serotypes
MAU868 Activity vs. Pooled Intravenous Immunoglobulin
• MAU868 is a human IgG1-λ monoclonal antibody (IVIG - Cytotect)
• MAU868 potently binds to and neutralizes BKV
MAU868
‒ MAU868 neutralizes BKV infection of renal proximal genotype I
tubular epithelial cells and prevents cell-to-cell spread MAU868
% Inhibition of BKV
genotype IV
‒ No resistance-associated genotype variants
Cytotect
• MAU868 is ~10,000-fold more potent than genotype I
hyperimmune immunoglobulin (IVIG, Cytotect)
Cytotect
‒ IVIG preparations occasionally used to treat some patients genotype IV
with reactivated BKV
Antibody Concentration (μg/mL)
‒ Clinical efficacy of IVIG preparations has not been
consistently demonstrated MAU868 Binding Affinity to BKV Serotypes
‒ Observed IVIG activity has been limited to BKV genotype I MAU868 KD (pM) EC50 (nM) EC50 (μM/mL)
BKV Serotype I 5.8 ± 1.8 0.062 ± 0.068 0.009 ± 0.010
BKV Serotype II 2.8 ± 0.6 0.278 ± 0.175 0.040 ± 0.025
BKV Serotype III 8.4 ± 3.7 0.645 ± 0.397 0.093 ± 0.057
BKV Serotype IV 4.1 ± 1.3 0.143 ± 0.135 0.021 ± 0.020
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© 2022 VERA THERAPEUTICS, INC.BKV Treatment Paradigms
Goal of therapy: prevent clinically significant viremia/disease
3
2 Treatment (3)
For patients with high levels of
1b
viremia, with or without biopsy
1a Preemptive therapy (2)
confirmed disease/renal
For patients with low levels of
Prophylaxis (1b) insufficiency (≥ 104 DNA copies/mL)
Prophylaxis (1a): viremia (Phase 2 Trial of MAU868 in Kidney Transplant Patients with Active BKV
MAU868-201 Trial Design
Study Population Randomized, Double-blind, Placebo-controlled Phase 2 Study Study Endpoints
• Kidney transplant within 12 Week 24 Week
Treatment Follow-up Primary
one year of enrollment in
2:1 • Safety, tolerability
the trial Randomization
Secondary
• Documented BKV viremia
within 10 days prior to Kidney MAU868 Patient Follow-up • BKV-related
Transplant outcomes including
enrollment in the trial Patients with R
BKV Viremia Placebo Patient Follow-up viremia, nephropathy,
• Viral load ≥ 104 log10 graft function and
copies/ml, rejection, PK
but no more than ≤ 107
week 0 12 36
log10 copies/ml, or
consecutive positive VLs if 3 Dose Cohorts (n=12 each) 4 IV doses over 12-wks
most recent is ≥ 103 log10 Cohort 1 1350 mg x 4
copies/ml Cohort 2 6750 mg x 1 followed by 1350 mg x3
15-20 sites (US, CAN) planned
as of November 2021
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Clinicaltrials.gov Identifier: NCT04294472
© 2022 VERA THERAPEUTICS, INC.Phase 2 Trial Update
Dynamic Study Launch MAU868-201 Trial
• The Phase 2 trial of MAU868 in renal transplant patients
MAU-201 Sites and Enrollment
has exceeded enrollment expectations
16 16
‒ Trial initiation, planned for April 2020, was paused due to 14 patients
COVID-19 – site start-up continued 14 enrolled & dosed 14
‒ In late July 2020, the trial was opened for enrollment 12
Cohort 1 Target N=12
12
‒ Cohort 1 enrollment was completed ahead of schedule
10 10
• Cohort 1 Update:
# Sites
# Pts
8 8
‒ All 14 patients in Cohort 1 and 14 patients in Cohort 2 have
completed the 12-week double-blind study treatment period 6 6
(4 infusions)
4 4
‒ Interim analysis demonstrates MAU868 is well-tolerated
2 2
‒ Interim analysis demonstrates a greater proportion of
subjects have decrease in BK plasma viral load versus 0 0
placebo. Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20
Sites open Actual Projected
‒ Full Cohort 1 and 2 interim analysis results will be submitted
for presentation at a conference in mid-2022.
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© 2022 VERA THERAPEUTICS, INC.MAU868 Asset Acquisition Payments Overview
Upfront
– $5mm upfront
Payment
2021: Achievement of primary specified endpoint – $2mm
2022: 1st patient dosed in a Phase 3 trial – $5mm
Regulatory 2026: U.S. regulatory approval for 1st indication – $12mm 2026: U.S. regulatory approval for 1st indication – $5mm
Milestones 2026: European regulatory approval for 1st indication – $10mm 2026: European regulatory approval for 1st indication – $2mm
2026: Regulatory approval in any jurisdiction for a 2nd indication – $5mm
2028: PRC or Japan regulatory approval for 1st indication – $5mm
Net sales ≥ $100mm – $5mm
Commercial
Net sales ≥ $200mm – $10mm –
Milestones Net sales ≥ $300mm – $15mm
Net sales ≤ $200mm – 6%
Royalties Net sales > $200mm and ≤ $500mm – 8% 2% royalties on net sales
Net sales > $500mm – 10%
Nominal
TOTAL
$69mm $12mm
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© 2022 VERA THERAPEUTICS, INC.MAU868: A Compelling Addition to Vera’s Pipeline
A potent, neutralizing monoclonal antibody against BK virus
Multiple patient populations
No specific or effective anti-BKV therapies available
Large potential market opportunity
Fast-track designation granted by FDA
Potential to be the first effective therapy for BKV in the United States
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© 2022 VERA THERAPEUTICS, INC.8000 Marina Boulevard, Suite 120
Brisbane, CA 94005
info@veratx.com
+1 (650) 770-0077
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