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Vera Therapeutics - Public Presentation - December 2021 - VF
Vera Therapeutics - Public Presentation - December 2021 - VF
Presentation
C
December 2021
© 2021 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, 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 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 place undue reliance on these forward‐looking
statements, which speak only as the date of this presentation.
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
made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.
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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© 2021 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
Additional autoimmune indications increase blockbuster potential, including lupus nephritis
Strong financial profile, with approximately $135M gross proceeds raised in the last 12 months,
which management believes to be sufficient to fund operations through 2022
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© 2021 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
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© 2021 VERA THERAPEUTICS, INC.
Vera’s Financial Position
~$135M Current capital
gross proceeds ~$86.2M position
raised in the last 12 Cash and cash expected to be
months including equivalents sufficient through
May IPO
NASDAQ: VERA
(As of 9.30.21)
2022
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© 2021 VERA THERAPEUTICS, INC.
Strategic Vision: Lead Indications with Large Markets and Validating Clinical Data
• Vera has a worldwide, exclusive license to develop and commercialize atacicept from Merck KGaA
• Highly de‐risked clinical stage asset, studied in clinical trials in over 1,500 patients
• Experienced corporate development team with a strategic focus to develop novel therapies for immunologic diseases
Atacicept Additional Asset
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© 2021 VERA THERAPEUTICS, INC.
Multiple Significant Catalysts Expected in Near‐Term
Q4 2021 2022
FDA Feedback on Proposed initiation of
LN Study LN Study
Phase 2 or 2/3 Phase 2 or 2/3
(Q4 2021) (2022)
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© 2021 VERA THERAPEUTICS, INC.
Atacicept for IgAN
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© 2021 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‐
30s, severely impacting QoL
Prevalence
~126K
High‐Risk
Orphan Disease indication in the US and EU1 >1g/L proteinuria
~60K
Up to 50% of IgAN patients progress to end‐stage renal
Addressable
disease, resulting in need for dialysis or a transplant ~40K
No approved treatment indicated for IgAN
• Significant market opportunity ex‐US
• Higher incidence rates in Japan
9 1Orphan Disease Designation not yet obtained for atacicept in IgAN. 2ClearView Healthcare Partners Analysis.
© 2021 VERA THERAPEUTICS, INC.
Currently No Approved Drugs for IgAN, Suboptimal Standard of Care
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
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
11 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.
© 2021 VERA THERAPEUTICS, INC.
Atacicept Targets Immune Complex Formation, Upstream in IgAN Pathogenesis
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© 2021 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
13 Lai et al. Nature Reviews 2016.
© 2021 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
14 1Zhao N et al. Kidney Int 2012. 2Suzuki et al. JCI 2009. 3Berthoux F et al. J Am Soc Nephrol 2012.
© 2021 VERA THERAPEUTICS, INC.
First Molecule to Significantly Reduce Gd‐IgA1 (60%) in IgAN Patients
‐20
Currently in
‐25% Ph 2b study1
‐30
‐40
‐50
‐60
‐60%
‐70
15 Barratt et al. American Society of Nephrology 2020. 1150 mg not tested in Ph2a study; Results from Ph 2b study not yet available.
© 2021 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
After 24 Weeks, all subjects receiving atacicept 75mg had reductions in serum Gd‐IgA1 to the lowest risk quartiles
16 Barratt et al. American Society of Nephrology 2021.
© 2021 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
17 Barratt et al. ERA EDTA 2020.
© 2021 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
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
18 1Phase 2a JANUS Trial CTR Table 13.3.3.21. 2Phase 2a JANUS Trial CTR Table 15.3.3.9.
© 2021 VERA THERAPEUTICS, INC.
Phase 2a IgAN Trial (JANUS): Clear Dose‐Dependent Reductions on Serum Igs
19 Phase 2a JANUS Trial CTR.
© 2021 VERA THERAPEUTICS, INC.
Phase 2a IgAN Trial (JANUS): Dose‐Dependent, Durable Gd‐IgA1 Reduction
20 Phase 2a JANUS Trial CTR, Figure 15.3.3.39.
© 2021 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
week ‐4 0 24 36 96/ET 26
10 Endpoint 20 Endpoint
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© 2021 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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© 2021 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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© 2021 VERA THERAPEUTICS, INC.
We Believe Atacicept Has Best‐in‐Disease Potential in IgAN
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 PDUFA
Phase 3 Phase 1/2 Phase 3 Phase 3 Phase 2 Phase 2b
Development Dec. 2021
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 11/30/2021 FactSet 2Fellström et al. The Lancet 2017. 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
24 Release 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
© 2021 VERA THERAPEUTICS, INC.
Potential Advantages of atacicept’s Dual APRIL/BLYS Blockade Over APRIL‐
Only Approaches
Preference for self‐administered 1mL subcutaneous (SC) administration due to convenience and
comfort of home treatment and the avoidance of clinical interaction required for intravenous
(IV) administration
Atacicept has clinical data in >1,000 patients demonstrating acceptable therapeutic window for the
doses currently in clinical trials: 25mg, 75mg, 150mg
Because of dual‐APRIL/BLYS inhibition, atacicept may provide greater inhibition of autoantibody
production than APRIL only, resulting in a similar effect on Gd‐IgA1 at lower doses
• For ~60% reduction in Gd‐IgA1: atacicept 75mg SC qwk, BION‐1301 450mg IV q2w
• BION‐1301 being explored as 600 mg (150mg/mL), in two 2mL subcutaneous injections
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© 2021 VERA THERAPEUTICS, INC.
Lupus Nephritis Expansion
Could Increase Atacicept’s
Blockbuster Potential
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© 2021 VERA THERAPEUTICS, INC.
Atacicept for Lupus Nephritis: Dual BLyS‐APRIL Inhibition Shows Potential to
Outperform Approved BLyS‐only Drug
Bone Marrow
CD138+ PC [thousands/ 2 femurs]
100
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 still <50%
In mouse model of lupus nephritis, more
*As this data is based on a cross‐trial comparison and not a head‐to‐head clinical
reductions in bone marrow plasma cells trial, such data may not be directly comparable due to differences in study
protocols, conditions and patient populations.
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© 2021 VERA THERAPEUTICS, INC.
Atacicept Phase 2 Trial Shows Evidence of Clinical Efficacy in SLE
SLEDAI‐2K ≤2 Responder (%)
30
SRI‐6 Responders (%)
40
25
30 20
15
20
10 Δ=6.5%
10 (p=ns)
5
0 0
Screening 0 4 8 12 16 20 24 Screening 0 4 8 12 16 20 24
Week Week
1SRI‐6 response is defined as ≥6‐point reduction in the SELENA‐SLEDAI score, and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and no worsening (<0.30‐point
Lead clinical‐stage asset, atacicept, is a potential disease‐modifying agent that targets B‐cells and
plasma cells, the source of autoimmunity
Additional autoimmune indications increase blockbuster potential, including lupus nephritis
Strong financial profile, with approximately $135M gross proceeds raised in the last 12 months,
which management believes to be sufficient to fund operations through 2022
29
© 2021 VERA THERAPEUTICS, INC.
8000 Marina Boulevard, Suite 120
Brisbane, CA 94005
info@veratx.com
+1 (650) 770‐0077
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© 2021 VERA THERAPEUTICS, INC.