false 0001831828 0001831828 2025-01-13 2025-01-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2025
Vera Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-40407 |
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81-2744449 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
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2000 Sierra Point Parkway, Suite 1200 Brisbane, California |
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94005 |
(Address of principal executive offices) |
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(Zip Code) |
(650) 770-0077
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Class A common stock, $0.001 par value per share |
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VERA |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 |
Regulation FD Disclosure. |
On January 13, 2025, Vera Therapeutics, Inc. (the “Company”) released an updated corporate presentation entitled “J.P. Morgan Healthcare Conference”. The presentation is available on the Company’s website, and a copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. For important information about forward-looking statements, see the slide titled “Forward Looking Statements” in Exhibit 99.1 attached hereto.
The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained in this Item 7.01 and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Vera Therapeutics, Inc. |
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Dated: January 13, 2025 |
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By: |
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/s/ Marshall Fordyce, M.D. |
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Marshall Fordyce, M.D. |
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Chief Executive Officer |
Exhibit 99.1 J.P. Morgan Healthcare Conference January 13, 2025 ©
2025 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 within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, atacicept's potential to be a transformational treatment for patients with IgAN and a best-in-class and first-in-class therapy, the Company's expectations
regarding completing the pivotal Phase 3 ORIGIN 3 trial and the Phase 2 extension study in participants who completed the Phase 2b or Phase 3 ORIGIN trials, atacicept's potential to be a transformational treatment for additional patient cohorts
beyond those with IgAN, the Company's expectations regarding initiating clinical trials of atacicept for additional indications, the design and management of the Company's clinical trials, expectations regarding reporting results from such clinical
trials and regulatory matters, including the timing and likelihood of success in obtaining drug approvals, atacicept's projected launch and Vera's potential research and development plans for VT-109. Words such as “anticipate,”
“plan,” “expect,” “will,” “may,” “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
related to the regulatory approval process, the potential that results of earlier clinical trials may not be obtained in later clinical trials, risks and uncertainties associated with the Company's business in general, the impact of macroeconomic
and geopolitical events, and the other risks described 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 place undue reliance on these
forward-looking statements, which speak only as of the date of this presentation, and are based on management's assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or
circumstances that exist after the date on which they were made, except as required by law. Certain data in this presentation are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comparisons are
inherently limited and may suggest misleading similarities or differences. This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities, or a solicitation of any vote or approval, nor shall there be
any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Investment in any securities described herein has not
been approved or disapproved by the Securities and Exchange Commission or any other regulatory authority nor has any authority passed upon or endorsed the merits of the offering or the accuracy or adequacy of the information contained herein. Any
representation to the contrary is a criminal offense. 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. 2 © 2025 VERA THERAPEUTICS, INC.
Atacicept potentially first and best-in-class dual BAFF/APRIL B cell
modulator in IgAN, with pipeline-in-a-product opportunity IgAN Potential Best-in-Class Potential Indication Expansion Resourced for Potential Launch • eGFR normalization may suggest • B cell modulation represents a • Currently
~$677M pro forma cash, functional cure; FDA Breakthrough treatment paradigm shift for cash equivalents and marketable 1 Therapy Designation awarded 2024 autoimmune diseases securities as of September 30, 2024 • Only program with 2-year data in
• Progressive expansion in addressable • Management focused on potential for Phase 2 à potential for commercial patients: initial autoimmune kidney successful commercial launch differentiation, if approved disease opportunity
>200K • Phase 3 read out on track for Q2 2025; • Only investigational drug with at • Strong clinical potential in if successful, anticipated PDUFA home self admin of 1 mL SC QW and hematologic, rheumatologic, and date 2026 90%
patient retention at 2 years other indications APRIL = A proliferation inducing ligand; BAFF = B cell activating factor; eGFR = estimated glomerular filtration rate; IgAN = immunoglobulin A nephropathy; PDUFA = Prescription Drug User Fee Act; QW =
once weekly; SC = subcutaneous. 1. Includes ~$353M of cash, cash equivalents and marketable securities as of September 30, 2024 and additional ~$324M in net proceeds from October 2024 follow-on equity offering. This estimate of the Company’s
cash, cash equivalents and marketable securities as of September 30, 2024 has not been audited. 3 © 2025 VERA THERAPEUTICS, INC.
Cumulative Atacicept data to date supports best-in-class potential 1 2 3
Atacicept Sibeprenlimab Povetacicept Zigakibart Mechanism BAFF/APRIL inhibition APRIL inhibition only BAFF/APRIL inhibition APRIL inhibition only 25/75/150 mg SC QW (Phase 2) 2/4/8 mg/kg IV (Phase 2) 80/240 mg SC QM (Phase 1b) 450 mg IV Q2W (Phase
2) Dosing & 150 mg SC QW (Phase 3) 400 mg SC QM (Phase 3) 80 mg SC QM (Phase 3) 600 mg SC Q2W (Phase 3) Administration 1x1 mL self-administered 1x2 mL in-clinic injection 1xTBD mL in-clinic injection 2x2 mL in-clinic injection Development Stage
Phase 3 Phase 3 Phase 3 Phase 3 Randomized ✓✓✗✗ Controlled Trial Data 64% at W36 ~60% at W52 No placebo No placebo Gd-IgA1 Reduction vs 7% placebo vs ~+20% placebo controlled data controlled data Reductions at W36
Hematuria 80% resolution at W36 Not reported Not reported (nonquantifiable) UPCR Reduction No placebo No placebo Δ 43% (p=0.003) at W36 Δ 43% at W36 vs Placebo controlled data controlled data eGFR Duration Data 24 months, n=102 12 months,
n=145 12 months, n=8 19 months, n=33 Projected 2026 2026 2027 2027 Commercial Launch 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. Atacicept 150 mg data from Phase 2b ORIGIN trial shown for urine protein-creatinine ratio (UPCR), galactose-deficient immunoglobulin A1 (Gd-IgA1), and hematuria. 1. Phase 2 4 mg/kg IV Gd-IgA1 data from
Mathur M, et al. NEJM 2023, Phase 2 4 mg/kg IV hematuria data from Barratt J, et al. WCN 2024, WCN24-AB-1799, Phase 2 pooled sibeprenlimab UPCR data from Kooienga ASN 2022, TH-PO991, and eGFR data from Barratt J, et al. ASN 2023, abstr TH-PO1124; 2.
Phase 1b 80 mg data from Madan A, et al. ASN 2024, FR-PO854; 3. Barratt J, et al. ASN 2024, FR-PO856. 4 © 2025 VERA THERAPEUTICS, INC.
Strong Financial Position ~$677M ~63.4M Shares outstanding Cash, cash
equivalents, (as of 11.21.24) and marketable securities 1 (pro forma unaudited as of 9.30.24) 1. Includes ~$353M of cash, cash equivalents and marketable securities as of September 30, 2024 and additional ~$324M in net proceeds from October 2024
follow-on equity offering. This estimate of the Company’s cash, cash equivalents and marketable securities as of September 30, 2024 has not been audited. 5 © 2025 VERA THERAPEUTICS, INC.
Vera optionality to expand in autoimmune kidney disease & beyond US
prevalence estimates ~230K Potential Future Indications 1-10 + ~70K Hematology ITP, AIHA, CAD, APS 1 ~160K Rheumatology Non-IgAN SLE, Sjogren’s, Long COVID autoimmune Neurology kidney disease MG PMN, FSGS, MCD and Metabolism Expanded IgAN DM
Type 1 BAFF/APRIL inhibition Vera Therapeutics corporate estimates for peak year prevalence based on 1. ClearView Healthcare Partners Analysis; 2. US Census 2023; 3. McGrogan A. Nephrol Dial Transplant 2011; 4. Couser ASN 2017; 5. Beck LH. N Engl J
Med 2009; 6. Filler G. Am J Kidney Dis 2003; 7. Troyanov S. J Am Soc Nephrol 2005. 8. Hommos MS. Mayo Clin Proc 2017; 9. Hengel FE. N Engl J Med 2024; 10. Vivarelli M. Clin J Am Soc Nephrol 2017. PMN = primary membranous nephropathy; FSGS = focal
segmental glomerulosclerosis; MCD = minimal change disease; ITP = immune thrombocytopenia; AIHA = autoimmune hemolytic anemia; CAD = cold agglutinin disease; APS = antiphospholipid syndrome; SLE = systemic lupus erythematosus; COVID = Coronavirus
disease 2019; MG = myasthenia gravis; DM = diabetes mellitus. 6 © 2025 VERA THERAPEUTICS, INC.
Atacicept Projected Catalysts Catalyst 2025 2026 2Q Phase 3 full
enrollment Phase 3 primary endpoint 2Q IgAN BLA submission 2H 1 Projected US launch IgAN Initial data Initiation IgAN, PMN, FSGS, MCD Initial data Vera holds worldwide, exclusive rights to develop and commercialize atacicept Based on
management’s current assumptions. 1. Subject to US approval. 7 © 2025 VERA THERAPEUTICS, INC.
Dual BAFF/APRIL inhibition has broad therapeutic potential to address
multiple autoimmune diseases Immunity in health BAFF Antibodies bind to foreign antigens B cell APRIL Autoimmune disease Autoantigens and autoantibodies mediate BAFF autoimmune disease Autoantibodies bind to autoantigens B cells source of
autoantibodies → target cell of B cell interest for therapeutic intervention B cells fueled by two cytokines, BAFF and APRIL APRIL Atacicept: Rationally designed therapeutic of modern biotechnology that binds BAFF and APRIL with nanomolar
potency offers the promise of precision modulation of B cells and autoantibodies 8 © 2025 VERA THERAPEUTICS, INC.
Atacicept is an example of rational drug design Native TACI-Fc fusion:
Soluble protein binds both BAFF and APRIL with nanomolar potency Atacicept BAFF APRIL BAFF APRIL 1 t =35 days 1/2 Kd Kd 2 2 1.45 nM 0.672 nM TACI TACI receptor receptor B cell Fc domain B cell of IgG1 Fc = fragment crystallizable; IgG1 =
immunoglobulin G1; Kd = dissociation constant; TACI = transmembrane activator and calcium-modulator and cyclophilin ligand. 1. Willen D, et al. Eur J Drug Metab Pharmacokinet 2020;45(1):27-40; 2. Vera data on file. 9 © 2025 VERA THERAPEUTICS,
INC.
ORIGIN Phase 2b long-term data revealed in late breaking oral
presentation at ASN Kidney Week and JASN manuscript Double-Blind Treatment Open-label Extension Placebo n=30 Atacicept 25 mg QW n=15 Atacicept 150 mg QW Atacicept 75 mg QW n=30 Atacicept 150 mg QW n=30 Week 0 24 36 72 96 1° Endpoint 2°
Endpoint Interim Analysis Longest duration B cell modulator Inclusion Criteria Endpoints data to date • Participants ≥18 years old with biopsy-proven • Primary efficacy: UPCR-24h at week 24 IgAN and high risk of disease progression
• Key secondary: UPCR-24h at week 36 • Stable and optimized RAASi for ≥12 weeks • eGFR change up to week 96 • Use of SGLT2i allowed • Gd-IgA1 change • UPCR-24h >0.75 g/g or UP >0.75 g per 24h •
Hematuria change 2 • eGFR ≥30 mL/min/1.73 m • Safety • Blood pressure ≤150/90 mmHg ET = end of treatment; RAASi = renin-angiotensin-aldosterone system inhibitor; SGLT2i = sodium-glucose cotransporter-2 inhibitor. 10
© 2025 VERA THERAPEUTICS, INC.
90% of participants completed atacicept treatment through 2 years 232
screened 116 failed screening Randomized 116 randomized and treated double-blind treatment period 1 1 82 atacicept 34 placebo 2 3 2 discontinued treatment 3 discontinued treatment Completed week 36 and entered OLE 80 (98%) 31 (91%) OLE period 111
entered OLE 4 9 discontinued treatment 5 102 completed week 96 90% completed atacicept treatment OLE = open-label extension. 1. Full analysis set and safety population. 2. Discontinued to pursue elective surgery (n=1), and discontinued due to
positive hepatitis B DNA and adverse event (n=1). 3. Initiated prohibited medication for concomitant disease (n=1), discontinued due to plan to start prohibited medication for concomitant disease (n=1) and adverse event (n=1). 4. Discontinued due to
investigator decision (n=1), pregnancy (n=2), participant withdrawal (n=2), surgery (n=1), serious adverse event of pneumonia in a heavy smoker, resolved (n=1), adverse event of worsening alanine aminotransferase and aspartate aminotransferase
(n=1), and medical monitor criteria (n=1). 5. 90% = 102/113 (out of the 116 randomized and treated participants, 3 discontinued placebo prior to week 36). 11 © 2025 VERA THERAPEUTICS, INC.
We believe an ideal IgAN disease modifying therapy would be expected
to… Reduce Gd-IgA1 Resolve hematuria Reduce proteinuria Stabilize eGFR 12 © 2025 VERA THERAPEUTICS, INC.
ORIGIN Phase 2b 96-week results consistent with IgAN disease
modification Including eGFR profile consistent with the general population of -1 mL/min/year Reduction in Gd-IgA1 Resolution of hematuria 0 0 -15 -20 -30 -40 -45 -60 -75% -60 -80 -66% -75 -100 0 12 24 36 48 60 72 96 0 12 24 36 48 60 72 84 96 Week
from First Atacicept Dose Week from First Atacicept Dose Set the n= 111 108 78 107 79 29 77 74 n= 63 62 60 60 61 61 43 41 40 standard Reduction in proteinuria Stabilization of eGFR in IgAN 0 10 5 -20 Slope 0 -0.6 mL/min/year -40 -5 2 Annualized eGFR
slope of -0.6 mL/min/1.73 m per year -52% Mean eGFR change from baseline -60 -10 0 12 24 36 48 60 72 84 96 0 12 24 36 48 60 72 84 96 Week from First Atacicept Dose Week from First Atacicept Dose n= 113 110 107 109 109 108 78 74 75 n= 112 110 108 108
109 108 78 76 75 Atacicept group includes all participants receiving any atacicept dose at each timepoint, with baseline (BL) defined as the last available measurement prior to the first dose of atacicept. Data from weeks 0 to 60 includes
participants who switched from placebo to atacicept. 1. Percentage changes from BL computed using FDA-endorsed mixed-effects modeling; 2. Percentages represent change from BL in number of participants with hematuria at each visit divided by number
with BL hematuria; 3. Changes from BL in eGFR were analyzed using MMRM analysis and LS estimation and SE were estimated from the model directly; eGFR slope was analyzed using mixed-effects model with random intercept and random slope and mean slope
and SE were estimated from the model directly. 13 © 2025 VERA THERAPEUTICS, INC. Mean ± SE % Change from BL Mean ± SE % Change from BL 1 1 in UPCR in Gd-IgA1 Mean ± SE Change from Mean Change from BL 3 2 2 BL in eGFR,
mL/min/1.73m in % Participants (95% CI)
Atacicept treated participants have eGFR slope profile consistent with
general population without kidney disease 4 Slope, mL/min/y 0 Atacicept ~ -0.6 General population ~ -1 1 estimate -4 IgAN natural history -8 including supportive 2 CKD therapy ~ -6 -12 0 12 24 36 48 60 72 84 96 Week 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. Projected eGFR trajectories for general population and IgAN natural
history do not represent clinical data and assume a constant eGFR slope over time. CKD = chronic kidney disease. 3-11 1. Slope estimate from Baba M, et al. PLOS ONE 2015; 2. Average historical placebo slope from 9 clinical trials ; 3. Lafayette R,
et al. Lancet 2023; 4. Rovin BH, et al. Lancet 2023; 5. Li PK-T, et al. Am J Kidney Dis 2006; 6. Manno C, et al. Nephrol Dial Transplant 2009; 7. Lv J, et al. JAMA 2017; 8. Wheeler DC, et al. Kidney Int 2021; 9. Lv J, et al. JAMA 2022; 10. Zhang H,
et al. ASN Kidney Week 2023, poster TH-PO1123; 11. Mathur M, et al. N Engl J Med 2023. 14 © 2025 VERA THERAPEUTICS, INC. Change from Baseline in 2 eGFR, mL/min/1.73m
2024 Draft KDIGO IgAN guidelines call for target eGFR slope ≤ -1
mL/min/year 1 % patients who will reach kidney failure 0 25 50 75 100 -0.1 0 0 2 2 1 1 -0.5 25 17 19 15 6 8 -1 56 40 38 40 23 16 -2 100 89 80 78 60 26 2 Endothelin receptor antagonist ~ -3 -3 100 100 100 91 85 46 3 4 SGLT2i , corticosteroid ~ -4 -5
100 100 100 100 95 59 5 Supportive CKD therapy ~ -6 0 – <18 18 – <30 30 – <40 40 – <50 50 – <60 60 – 75 Age group 1. Adapted from Pitcher D, et al. CJASN 2023. eGFR slope data from approved
therapies: 2. Rovin BH, et al. Lancet 2023; 3. Wheeler DC, et al. Kidney Int 2021; 4. Lafayette R, et al. Lancet 2023; 5. Average historical placebo (including chronic kidney disease standard of care) data from 9 clinical trials: Li PK-T, et al. Am
J Kidney Dis 2006; Manno C, et al. Nephrol Dial Transplant 2009; Lv J, et al. JAMA 2017; Wheeler DC, et al. Kidney Int 2021; Lv J, et al. JAMA 2022; Zhang H, et al. ASN Kidney Week 2023, poster TH-PO1123; Mathur M, et al. N Engl J Med 2023;
Lafayette R, et al. Lancet 2023, Rovin BH, et al. Lancet 2023. 15 © 2025 VERA THERAPEUTICS, INC. 2 Annual eGFR slope, mL/min/1.73m
Discontinuation of Atacicept resulted in pronounced increase in Gd-IgA1
and decrease in eGFR, potentially supporting a paradigm of chronic treatment Gd-IgA1 % Change eGFR Change Last Atacicept Dose Last Atacicept Dose 150 0 -1 +117% 100 -2 -3 50 -4 -3.9 2 mL/min/1.73m 0 -5 96 +12 +26 96 +12 +26 Study Week Study Week
Follow-up Week Follow-up Week n= 103 102 101 n= 103 103 101 Analysis includes participants treated with atacicept who had a last on-treatment Gd-IgA1 or eGFR value in the study week 96 analysis window and at least one measure in the follow-up
period, with the study week 96 values reset as the new baseline and analyzed along with the follow-up week 12 and 26 data. Gd-IgA1 % changes were computed using FDA-endorsed mixed-effects modeling. eGFR changes were analyzed using MMRM analysis and
LS estimation and SE were estimated from the model directly. 16 © 2025 VERA THERAPEUTICS, INC. Mean ± SE % Change from Study Week 96 Mean ± SE Change from 2 Study Week 96, mL/min/1.73m
Consistency with ORIGIN 2b instills confidence in ORIGIN 3 Double-Blind
Treatment Open-label Extension Placebo Atacicept 150 mg QW Atacicept 150 mg QW 156 Week 0 36 104 2° Endpoint 1° Endpoint eGFR: n=376 UPCR: n=200 Full enrollment 2Q 2025 expected Q2 2025 Fully enrolled Key Inclusion Criteria Key Endpoints
• Patients ≥18 years old with biopsy-proven • Primary efficacy: UPCR-24h at week 36 IgAN and high risk of disease progression to support potential accelerated approval – >90% power at week 36 • Stable and optimized
RASi for ≥12 weeks, use of SGLT2i allowed • Key secondary: eGFR change up to week 104 • UPCR-24h ≥1.0 g/g or UP ≥1.0 g per 24h – 90% power for eGFR Δ 4 mL/min at week 104 2 • eGFR ≥30 mL/min/1.73
m • Safety • Blood pressure ≤150/90 mmHg • Operational efficiency leveraging similar trial design and worldwide sites as ORIGIN 2b • Same self-administered SC formulation and dose as used in ORIGIN 2b RASi =
renin-angiotensin system inhibitor. 17 © 2025 VERA THERAPEUTICS, INC.
ORIGIN Extend: Commitment to providing long-term access to atacicept
for all ORIGIN participants Off treatment ORIGIN 2b Group 1 Atacicept 150 mg QW ORIGIN 3 Group 2 Week 0 156/Beyond • Phase 2 extension study in participants who complete ORIGIN 2b/3 • Objectives: 1. Provide patients with extended access
to atacicept prior to commercial availability in their country/region 2. Capture longer-term data for research purposes 3. Generate data from reinitiation of atacicept treatment following off-treatment period 18 © 2025 VERA THERAPEUTICS, INC.
Atacicept at home, self-administered QW dosing highly attractive; QM
program under way in 2025 • Biologic therapies utilizing at home, self-administered, vs SC 1 mL QW dosing have shown high compliance t • This dosing paradigm has the potential to support atacicept as a 1/2 1 foundational therapy for IgAN
35 days • Atacicept’s half life also supports evaluation of extended dosing • QM dose finding study in 2025 1. Willen D, et al. Eur J Drug Metab Pharmacokinet 2020;45(1):27-40. 19 © 2025 VERA THERAPEUTICS, INC.
Targeting B cell production of autoantibodies against glomerular
antigens offers the potential of additional kidney indications B Cell Activation Autoantibody Production Immune Complex Deposition Leading to Glomerulonephritis and Kidney Damage BAFF Anti-Gd-IgA1 antibodies IgAN B cell Anti-PLA2R antibodies
Anti-PLA2R podocytopathy APRIL Anti-nephrin antibodies Anti-nephrin podocytopathy Atacicept Antibodies associated with… Other autoimmune kidney diseases PLA2R = phospholipase A2 receptor. 20 © 2025 VERA THERAPEUTICS, INC.
PIONEER: Phase 2 basket trial in expanded IgAN and anti-PLA2R &
anti-nephrin podocytopathies Atacicept 150 mg QW Population 1, n ≤120 1 Expanded IgAN populations Week 0 36 52 1° Endpoint 2° Endpoint Key Endpoints Population 2, n ≤20 • Primary: UPCR change at week 36 Anti-PLA2R
podocytopathy • Key secondary: eGFR change at weeks 36, 52 (Membranous Nephropathy) • Exploratory: – Gd-IgA1 change at weeks 36, 52 – Change in percentage of participants with hematuria at weeks 36, 52 Population 3, n
≤20 – Change in anti-PLA2R antibodies Anti-nephrin podocytopathy – Change in anti-nephrin antibodies (Minimal Change Disease/FSGS) • Safety 2 1. 6 cohorts: adult IgAN with eGFR 20 to <30 mL/min/1.73 m , n ≤20; adult
IgAN with UPCR <1.0 g/g, n ≤50; adult IgAN with UPCR ≥5.0 g/g, n ≤20; adolescent (≥15 y) IgAN with UPCR ≥0.3 g/g, n ≤10; Adult recurrent IgAN post kidney transplant, n ≤10; adolescent and adult IgA
vasculitis nephritis, n ≤10. 21 © 2025 VERA THERAPEUTICS, INC.
Established leadership in B cell modulation and expanded breadth of
expertise positions Vera for further innovation R&D Accomplishments Corporate Growth Jan 25 R&D Day: 72-week results Research & discovery ERA best abstract Bioassay and biomarkers ORIGIN FDA BTD for atacicept in IgAN Clinical
pharmacology 2b 96-week disease modification presented Translational medicine in ASN LB oral and JASN manuscript New talent Preclinical development & functional Pharmacovigilance expertise ORIGIN Primary endpoint cohort enrolled Field Medical
Directors 3 Health economics & outcomes research Commercial 2024 ORIGIN Study initiated Extend Strong Two transformative financings leading 1 to ~$677M pro forma cash position financial position Atacicept indication expansion to PIONEER broader
IgAN cohort, PMN, FSGS, MCD 1. Unaudited as of September 30, 2024. Includes ~$353M of cash, cash equivalents and marketable securities as of September 30, 2024 and additional ~$324M in net proceeds from October 2024 follow-on equity offering. This
estimate of the Company’s cash, cash equivalents and marketable securities as of September 30, 2024 has not been audited. 22 © 2025 VERA THERAPEUTICS, INC.
Opportunity to innovate and extend leadership in B cell modulation
Current landscape of Monoclonal antibodies binding Fc fusion proteins containing either BAFF or APRIL alone TACI or TACI variants B cell modulators BAFF APRIL Atacicept Novel BCMA constructs Longest duration of represent an innovative B cell
modulator data to date B cell modulatory unlock showing eGFR stabilization TACI BCMA B cell receptors that bind both cytokines B cell production of pathogenic antibodies BCMA = B cell maturation antigen. 23 © 2025 VERA THERAPEUTICS, INC.
Novel, next-generation dual BAFF/APRIL inhibitor Potential for
additional patient benefit across diseases and populations BAFF APRIL • Novel molecule engineered by team at Stanford University Atacicept VT-109 • Picomolar binding affinity for BAFF and APRIL, attractive PK and half-life • Novel
composition may offer differentiation on Frequency of administration TACI BCMA B cell receptors that Route of administration bind both cytokines Other characteristics of molecule B cell production of pathogenic antibodies 24 © 2025 VERA
THERAPEUTICS, INC.
Vera Pipeline Research & Discovery Preclinical Clinical Marketed
Phase 3 IgAN Atacicept PMN, FSGS, MCD Phase 2 Potential future autoimmune indications Potential future VT-109 autoimmune indications MAU868 BK virus Phase 2 Vera holds worldwide, exclusive rights to develop and commercialize atacicept, VT-109, and
MAU868 25 © 2025 VERA THERAPEUTICS, INC.
© 2025 VERA THERAPEUTICS, INC.
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Vera Therapeutics (NASDAQ:VERA)
過去 株価チャート
から 12 2024 まで 1 2025
Vera Therapeutics (NASDAQ:VERA)
過去 株価チャート
から 1 2024 まで 1 2025