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Item 7.01 Regulation FD Disclosure.
On June 17, 2023, Vera Therapeutics, Inc. (the “Company”) announced positive week 36 results from the Company’s Phase 2b ORIGIN clinical trial evaluating its product candidate atacicept in patients with immunoglobulin A nephropathy (“IgAN”). In connection with the data release, the Company released an updated corporate presentation (the “Corporate Presentation”) on its website that includes the week 36 data from the Phase 2b ORIGIN clinical trial referenced above. A copy of the Corporate Presentation is furnished as Exhibit 99.1. For important information about forward-looking statements, see the slide titled “Forward-Looking Statements” in Exhibit 99.1 attached hereto.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission (“SEC”) made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
As noted in Item 7.01, on June 17, 2023, the Company announced positive week 36 results from the Company’s Phase 2b ORIGIN clinical trial evaluating its product candidate atacicept in patients with IgAN. Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator and a proliferation-inducing ligand. ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial (n=116) evaluating the efficacy and safety of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite available ACE or ARB therapy.
At week 36 in the prespecified per-protocol (“PP”) analysis, the atacicept 150 mg dose group showed a 43% placebo-adjusted reduction from baseline in proteinuria (p=0.003), compared to 35% in the intent-to-treat (“ITT”) analysis (p=0.012), as shown in Figure 1 below. In the ITT analysis of all randomized patients, patients receiving placebo had an expected decline in kidney function as measured by estimated glomerular filtration rate (“eGFR”), while patients receiving atacicept 150 mg had stable eGFR through week 36, as shown in Figure 2. This difference in eGFR was statistically significant (delta 11%, p=0.038) and clinically significant (5.8 mL/min/1.73 m2). In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1 (p<0.0001).
Figure 1. UPCR % Change With Atacicept 150 mg at Week 36
Figure 2. eGFR % Change With Atacicept 150 mg Through Week 36
Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, with no increased rate of infections compared to placebo, a low rate (2%) of serious adverse events overall, and no drug discontinuations or interruptions due to hypogammaglobulinemia. Serious treatment-emergent adverse events were observed in 3% of patients receiving atacicept 150 mg and in 9% of placebo patients. These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date across different indications - in which atacicept was well-tolerated.
Next Steps
Longer term results, including the ongoing eGFR data, from the Phase 2b ORIGIN clinical trial are planned for presentation later in 2023 and 2024. The Company is continuing to advance the pivotal Phase 3 development of atacicept 150 mg. The ORIGIN 3 clinical trial was initiated in June 2023. With the ongoing data from the Phase 2b trial through 2024 and Phase 3 topline results expected in the first half of 2025, if positive, the Company expects to submit a biologics license application (“BLA”) for atacicept in IgAN to the U.S. Food and Drug Administration in the second half of 2025, with a projected commercial launch, if approved, in 2026.
Forward-looking Statements
Statements contained in this Current Report on Form 8-K regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept’s potential to be a transformational treatment for patients with IgAN and a best-in-class therapy, the therapeutic potential of atacicept’s dual inhibitor approach to treating the cause of IgAN, the Company’s plans to enroll and complete the pivotal Phase 3 ORIGIN 3 trial, and expectations regarding reporting longer term results from the Company’s Phase 2b ORIGIN clinical trial, submitting a BLA and projected commercial launch. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “could,” “expects,” “will,” “potential,” “project,” “plan,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, 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, including the COVID-19 pandemic, and the other risks described in the Company’s filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Slide presentation entitled “Corporate Presentation”. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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.
| Vera Therapeutics, Inc. | ||||||
| Dated: June 20, 2023 | ||||||
| By: | /s/ Marshall Fordyce, M.D. | |||||
| Marshall Fordyce, M.D. | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1 Corporate Presentation June 2023 © 2023 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 atacicept's potential to be a transformational treatment for patients with IgAN and a best-in-class therapy, the Company's plans to advance atacicept into pivotal Phase 3 development in the first half of 2023, and regulatory matters, including the timing and likelihood of success in obtaining drug approvals and atacicept's projected launch. 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 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, including the COVID-19 pandemic, 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. 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 © 2023 VERA THERAPEUTICS, INC.
Corporate Highlights • Lead clinical-stage asset, atacicept, targets B cells and plasma cells with pipeline-in-a-drug potential and well-characterized safety profile – Phase 2b program in IgA Nephropathy (IgAN): clinical data in hand support best-in-class potential, with positive data read-out in June 2023 – Phase 3 initiated June 2023 based on feedback obtained from FDA and the ability to leverage multinational ORIGIN clinical sites from the Phase 2b trial • ~$197M cash, cash equivalents, and marketable securities as of 1 3.31.23 and access to a $25M credit facility sufficient to fund IgAN-focused operations through topline Phase 3 data into 2026 1. Unaudited. 3 © 2023 VERA THERAPEUTICS, INC.
Atacicept: Potential Value Creation Over Next 18 Months Catalyst 2023 2024 2025 2026 Initiated Phase 3 trial Q2 ✓ Presented 36-week data from ORIGIN trial Q2 ✓ 2H Present additional data from ORIGIN trial Q2, Q4 Present topline Phase 3 data 1H 2H BLA submission Projected launch Vera holds worldwide, exclusive rights to develop and commercialize atacicept Anticipated; based on management’s current assumptions and beliefs. 4 © 2023 VERA THERAPEUTICS, INC.
Management Team: Successful Clinical and Commercial Track Record Marshall Fordyce, MD Celia Lin, MD Sean Grant, MBA President and CEO Chief Medical Officer Chief Financial Officer • >15 years drug dev leadership • >10 years drug dev in Clinical • >15 years in corporate strategy, • 7 new drug approvals, Project Lead for Development and Medical Affairs finance, and capital raising tenofovir alafenamide program • Led Ph3 global trial execution in • Former healthcare banker with capital various therapeutics areas raising and M&A experience Joanne Curley, PhD Lauren Frenz, MBA Joe Young, CPA, MBA Chief Development Officer Chief Business Officer Chief Accounting Officer • >20 years drug dev, former VP project • 15 years industry experience, including • Leader of accounting & finance and portfolio management global commercial planning and operations for public and private multiple blockbuster launches at Gilead biotech companies, >20 years • Strategic advisory at SVB Leerink • Big 4 audit background Board and Select Investors Tom Doan Neeraj Pakala, PhD, MBA SVP, Clinical Operations SVP, Prod Dev and Manufacturing • >20 years of clinical operations • >20 years CMC experience including experience tech transfer and managing contract • Former Clinical Operations Therapeutic manufacturing organizations Area Head of Inflammation at Gilead 5 © 2023 VERA THERAPEUTICS, INC.
Financial Position ~$197M $25M Cash, cash equivalents, Credit facility available and marketable securities at Vera’s option (unaudited as of 3.31.23) Current capital position sufficient to fund IgAN-focused operations to ~44.3M Shares outstanding (as of 3.31.23) 2026 6 © 2023 VERA THERAPEUTICS, INC.
Large Unmet Medical Need and Significant Commercial Opportunity ~$6–10B Annual Market Opportunity in 2 US, EU, and Japan for Novel IgAN Therapeutics Serious and progressive autoimmune disease of the kidney; average age of diagnosis 30 years IgAN Diagnosed Prevalence old, severely impacting quality of life ~136K ~130K ~126K 1 Orphan disease indication in the US and EU ~80K ~65K ~60K Up to 50% of IgAN patients progress to ESRD, resulting in need for dialysis or transplant US EU Japan ESRD = end-stage renal disease. 1. Orphan Disease Designation not yet obtained for atacicept in IgAN; 2. ClearView Healthcare Partners Analysis. Prevalence and addressable population estimates based on peak year forecast. 7 © 2023 VERA THERAPEUTICS, INC. Addressable Prevalence
Rationale for Dual Inhibition of BLyS (BAFF) + APRIL with Atacicept for Patients with IgAN • Elevated BLyS plays key role in IgAN pathogenesis BLyS APRIL – BLyS and APRIL levels are both elevated in patients with IgAN and are 1-3 each associated with clinical severity – In preclinical models, overexpression of BLyS alone can lead to the 4 development of kidney IgA deposits and IgA-like nephritis – BLyS can directly increase the expression of factors associated with 2 fibrosis and inflammation in mesangial cells – Dual blockade of BLyS and APRIL decreased renal damage in an Atacicept immunologic animal model more than individual blockade of either 5 pathway alone • Dual inhibition may be necessary for maximal and sustained clinical efficacy – BLyS or APRIL alone are each capable of independently supporting plasma cell survival, indicating dual blockade may be necessary for BLyS-R TACI BCMA 5,6 maximal and sustained clinical efficacy – Blocking both biologic targets may avoid compensatory increase in 7 Autoantibodies parallel signal Immature Mature Plasma and immune B cell B cell cell – Blocking APRIL alone may lead to upregulation of BLyS signaling with complexes 8 potential consequences on efficacy • Dual inhibition enables lower dose, simpler product BLyS-R TACI BCMA – Atacicept 150 mg is self-administered as a single, small volume (1 mL) Immature B cell T cell independent antibody responses; Plasma cell survival survival and maturation B cell regulation; class-switch recombination injection, potentially optimizing patient experience APRIL = a proliferation-inducing ligand; BLyS = B lymphocyte stimulator, also known as BAFF; TACI = transmembrane activator and CAML interactor. 1. Xin G, et al. J Nephrol 2013; 2. Cao Y, et al. Mol Med Rep 2020; 3. Zhai Y, et al. Medicine (Baltimore) 2016; 4. McCarthy D, et al. J Clin Invest 2011; 5. Haselmayer P, et al. Eur J Immunol 2017; 6. Benson M, et al. J Immunol 2008; 7. Yeh T, et al. J Allergy Clin Immunol 2020; 8. Vallerskog T, et al. Arthritis Res Ther 2006. Atacicept is investigational and has not been approved by any regulatory authorities for any use. 8 © 2023 VERA THERAPEUTICS, INC.
Atacicept Binds BLyS and APRIL with Low Nanomolar Potency BLyS APRIL Kd 1.45 nM Kd 0.672 nM 70 54 60 46 200 nM 50 38 100 nM 200 nM 50 nM 40 30 30 22 50 nM 20 14 10 nM 10 nM 10 2 nM 6 Buffer 0 -2 Buffer -10 -10 200 300 400 500 600 700 800 900 1000 200 280 360 440 520 600 680 760 840 920 1000 Time, s Time, s Vera data on file. 9 © 2023 VERA THERAPEUTICS, INC. Resp. Diff, RU
Atacicept Targets Upstream Hits of IgAN Pathogenesis B Cell Maturation and Class-Switching Systemic Circulation Glomerulonephritis Lymphoid tissue BLyS IgA1 2 6 Plasma cell Plasma cell mistrafficking to the Gd-IgA1-containing APRIL systemic circulation immune complexes deposit in glomeruli 1 B cell priming 3 4 Atacicept reduces Atacicept Peyer’s Patch 1 anti-Gd-IgA1 reduces Gd-IgA1 B 2 antibodies 7 B BLyS Progressive Glomerulus renal injury Bacteria APRIL 5 B Atacicept reduces 3 immune complexes Steps that Atacicept targets Intestinal Tract Gd-IgA1 = galactose-deficient immunoglobulin A1. 1. Vera Therapeutics Jan 30 2023 press release; 2. Barratt J, et al. Nephrol Dial Transplant 2022;3 suppl 3, abstr FC051; 3. Barratt J, et al. ASN Kidney Week 2022, abstr SA-PO655. 10 © 2023 VERA THERAPEUTICS, INC.
Summary of Positive Phase 2b Week 36 Results PP Analysis ITT Analysis Met primary endpoint, with statistically significant *p<0.05 UPCR reductions on atacicept 150 mg Δ 43%*Δ 35%* Stable eGFR observed for patients on atacicept, Mean eGFR % change with atacicept 150 mg vs placebo was 11% (p=0.038), approximating to an with clinically meaningful and statistically 2 absolute difference of 5.8 mL/min/1.73 m significant difference vs placebo Gd-IgA1 reduction of 64% from baseline with atacicept 150 mg Clinical safety profile similar between atacicept and placebo Atacicept 150 mg dose selected for Phase 3 clinical trial, initiated in June 2023 eGFR = estimated glomerular filtration rate; ITT = intent to treat; PP = per-protocol; UPCR = urine protein:creatinine ratio. 11 © 2023 VERA THERAPEUTICS, INC.
ORIGIN Phase 2b IgAN Trial: Study Design and Objectives Multinational, randomized, placebo-controlled trial Double-Blind Treatment Open-label Extension Placebo n=30 Atacicept 25 mg qwk n=15 Atacicept 150 mg qwk Atacicept 75 mg qwk n=30 Atacicept 150 mg qwk n=30 Week 0 24 36 96/ET 1° Endpoint 2° Endpoint Inclusion Criteria Endpoints • Patients ≥18 years old with IgAN on renal biopsy • Primary efficacy: UPCR-24h at week 24 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 • Safety 2 • eGFR ≥30 mL/min/1.73 m • Blood pressure ≤150/90 mmHg ET = end of treatment; RAASi = renin-angiotensin-aldosterone system inhibitor; SGLT2i = sodium-glucose cotransporter-2 inhibitor. 12 © 2023 VERA THERAPEUTICS, INC.
30% Placebo-Adjusted Reduction in Proteinuria Known to be Clinically Meaningful in IgAN Patients • 30% placebo-adjusted reduction in proteinuria at week 36 is associated with 1 improvement of renal function in IgAN as measured by eGFR slope 2 • Placebo-adjusted reduction of 30% could delay ESRD by over 10 years • Early change in proteinuria at week 36 is an approvable surrogate endpoint for FDA accelerated approval, based on precedents set by Calliditas’ Tarpeyo 3 4 (Δ 31% ) and Travere’s Filspari (Δ 35% ) • eGFR slope at 2 years is the key confirmatory endpoint for full approval 1. Inker LA, et al. Am J Kidney Dis 2021;78:340-9.E1; 2. Barratt Lab, University of Leicester; 3. Tarpeyo [package insert]. Calliditas Therapeutics AB; 2021. 4. Filspari [package insert]. Travere Therapeutics, Inc.; 2023. ESRD = end stage renal disease. 13 © 2023 VERA THERAPEUTICS, INC.
Patient Disposition Screened, n=232 Screen Failures, n=116 Randomized and Treated, n=116 All Atacicept, n=82 Placebo, n=34 n=82 Safety and ITT population n=34 Prespecified Week 36 PP analysis n=73 (89%) n=26 (76%) Excludes patients with protocol violations as identified by blinded third-party CRO Discontinued Discontinued 1 2 n=2 (2%) n=3 (9%) n=80 (98%) Completed Week 36 and entered OLE n=31 (91%) Safety data includes all post-week 36 visits available at data-cut March 09, 2023. ITT = intent to treat; PP = per protocol; OLE = open label extension. 1. Discontinued to pursue elective surgery (1), discontinued due to positive hepatitis B DNA and adverse event (1). 2. Initiated prohibited medication for concomitant disease (1), discontinued due to plan to start prohibited medication for concomitant disease (1) and adverse event (1). 14 © 2023 VERA THERAPEUTICS, INC.
Demographics and Baseline Characteristics Overall Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Mean ± SD or n (%) n=116 n=16 n=33 n=33 n=34 Age, y 39 40 41 38 39 Male sex 69 (59) 9 (56) 19 (58) 22 (67) 19 (56) Race White 62 (53) 7 (44) 12 (36) 17 (52) 26 (76) Asian 51 (44) 7 (44) 20 (61) 16 (48) 8 (24) Other 3 (3) 2 (12) 1 (3) 0 0 2 eGFR, mL/min/1.73 m 63 ± 27.3 71 ± 28.7 64 ± 25.4 56 ± 22.7 66 ± 31.7 1.6 ± 0.9 1.6 ± 0.8 1.7 ± 0.9 1.7 ± 1.0 1.6 ± 0.8 UPCR by 24h urine, g/g SGLT2i use 16 (14) 3 (19) 3 (9) 4 (12) 6 (18) 15 © 2023 VERA THERAPEUTICS, INC.
UPCR % Change with Atacicept 150 mg at Week 36 1 ITT Analysis PP Analysis 20 10 5% 3% 0 -10 -20 -30 Δ 35% -33% p=0.012 -40 Δ 43% -40% p=0.003 -50 Placebo Atacicept 150 mg Placebo Atacicept 150 mg n=26 n=26 n=34 n=33 p-values, percentage changes from baseline, and treatment differences were computed using FDA-endorsed mixed-effects modeling which takes into account the effects of baseline UPCR and eGFR. 1. PP analysis excludes patients with protocol violations identified at week 36 data-cut prior to unblinding. 16 © 2023 VERA THERAPEUTICS, INC. Mean ± SE % Change from Baseline in UPCR-24h
eGFR Change with Atacicept 150 mg Through Week 36 15 10 5 1.6%Δ 11% p=0.038 0 5.8 2 mL/min/1.73 m -5 Absolute difference in mean change at week 36 -10 -8.5% -15 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 Week n= Placebo 34 34 34 34 34 30 Atacicept 150 mg 33 33 33 32 32 31 ITT analysis; p-values, percentage changes from baseline, and treatment differences were computed using FDA-endorsed mixed-effects modeling. 17 © 2023 VERA THERAPEUTICS, INC. Mean ± SE % Change from Baseline in eGFR
Dose-dependent Reductions Observed in Serum IgG, IgA, and IgM Through Week 36 IgG IgA IgM 0 0 0 0% -3% -4% * * * * -14% * -20 * -20 -20 * * * * * * * * -32% -32% * -37% -40 -40 -40 * * * * * * * * * * -54% * * * -59% -60 -60 -60 -63% * * * * -70% * -73% * * -80 -80 -80 0 4 8 12 16 20 24 28 32 36 0 4 8 12 16 20 24 28 32 36 0 4 8 12 16 20 24 28 32 36 Week Week Week n= Placebo 34 34 34 34 30 34 34 34 34 30 34 34 34 34 30 Atacicept 25 mg 16 16 16 15 15 16 16 16 15 15 16 16 16 15 15 Atacicept 75 mg 33 33 33 33 33 33 33 33 33 33 33 33 33 33 33 Atacicept 150 mg 33 33 32 32 30 33 33 32 32 30 33 33 32 32 30 ITT analysis; *p<0.001. p-values, percentage changes from baseline, and treatment differences were computed using FDA-endorsed mixed-effects modeling. 18 © 2023 VERA THERAPEUTICS, INC. Mean ± SE % Change from Baseline
Gd-IgA1 % Change Through Week 36 20 0 -7% * -20 * * * * -40 -39% * * * * -62% -60 * -64% * * -80 0 4 8 12 16 20 24 28 32 36 Week n= Placebo 33 33 33 33 29 Atacicept 25 mg 16 16 16 15 15 Atacicept 75 mg 33 33 33 33 33 Atacicept 150 mg 32 32 30 30 30 ITT analysis; *p<0.001 vs placebo. p-values, percentage changes from baseline, and treatment differences were computed using FDA-endorsed mixed-effects modeling. 19 © 2023 VERA THERAPEUTICS, INC. Mean ± SE % Change from Baseline in Gd-IgA1
Treatment-Emergent Adverse Events Through Week 36 Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Patients, n (%) n=16 n=33 n=33 n=34 TEAEs 11 (69) 24 (73) 25 (76) 27 (79) 1 Study drug-related TEAEs 6 (38) 17 (52) 19 (58) 14 (41) 2 3 4 Serious TEAEs 0 1 (3) 1 (3) 3 (9) TEAEs leading to study drug 5 6 0 0 1 (3) 1 (3) discontinuation Deaths 0 0 0 0 1. Majority of study drug-related TEAEs were injection site reactions; one contributed to drug discontinuation. 2. Multiple fractures, resolved, unrelated to study treatment. 3. Gastroenteritis norovirus, resolved, unrelated to study treatment. 4. Anaphylactic reaction resolved (n=1); forearm fracture resolved (n=1); flank pain not resolved and ulnar nerve paralysis resolved with sequelae (n=1); all unrelated to study treatment. 5. Discontinued after 3 injections due to injection site reaction and positive hepatitis B DNA that resolved without treatment 3 weeks later, normal liver function throughout. 6. Discontinued after 31 injections due to worsening flank pain that was not resolved; unrelated to study treatment. 20 © 2023 VERA THERAPEUTICS, INC.
Summary of Clinical Safety Data Through Week 36 Atacicept was generally well tolerated in IgAN patients, with no reported deaths, low rate (2%) of serious AEs overall, and 1 patient (1%) discontinued atacicept due to AE Infections were balanced between atacicept and placebo No study drug-related serious AE in atacicept 150 mg group No patient had study drug discontinuation or interruption due to hypogammaglobulinemia 21 © 2023 VERA THERAPEUTICS, INC.
Atacicept for IgAN Regulatory FDA Type C meeting Q4’22 & written feedback received Q2’23 enabled Update alignment on Ph3 protocol to accelerate Ph3 trial start in early June Ability to leverage ORIGIN worldwide sites Rapidly Advance Investigator familiarity with Ph2 dosing administration Phase 3 Multi-part study design streamlining Ph2b sites for Ph3 Atacicept 150 mg UPCR and eGFR met statistical significance and were clinically Dose Selection meaningful for atacicept 150 mg at week 36 in ORIGIN Ph2b Derisked Same SC formulation and dose as used in ORIGIN Ph2b, Phase 3 similar study design as ORIGIN Ph2b 22 © 2023 VERA THERAPEUTICS, INC.
ORIGIN Subgroup Analyses Informed Phase 3 Design to Maximize Competitive Positioning • Tested atacicept’s anticipated commercial formulation and setting (at home SC self administration) in patients with wide-spectrum disease severity and racially diverse backgrounds • Incorporated evolving SOC SGLT2i use in a multinational RCT Proprietary subgroup analyses that informed Phase 3 design and management included: eGFR UPCR Asian Region SGLT2i use 23 © 2023 VERA THERAPEUTICS, INC.
Initiated Phase 3 Pivotal Trial in June 2023 Atacicept Once Weekly SC Injection Formulation in Phase 3, Same as Phase 2b Double-Blind Treatment Open-label Extension Placebo Atacicept 150 mg qwk Atacicept 150 mg qwk Week 0 36 104 156 1° Endpoint 2° Endpoint UPCR: n=200 eGFR: n=376 Inclusion Criteria Endpoints • Patients ≥18 years old with IgAN on renal • Primary efficacy: UPCR-24h at week 36 biopsy and high risk of disease progression to support potential accelerated approval • Stable and optimized RASi for 12 weeks • Key secondary: eGFR change up to week 104 • Use of SGLT2i allowed • Safety • UPCR-24h ≥1.0 g/g or UP ≥1.0 g per 24h 2 • eGFR ≥30 mL/min/1.73 m • Blood pressure ≤150/90 mmHg 24 © 2023 VERA THERAPEUTICS, INC.
Attractive Commercial Drug Product Profile • Self-administration of small volume (1 mL) via autoinjector at commercial launch • Smallest volume among B-cell modifying drugs in development (2–4 mL with APRIL-only) • Large subcutaneous injection volumes are associated with pain and may affect tolerability 1 and adherence 1. Usach I, et al. Adv Ther 2019;36(11):2986-2996. 25 © 2023 VERA THERAPEUTICS, INC.
Atacicept: Potential Value Creation Over Next 18 Months Catalyst 2023 2024 2025 2026 Initiated Phase 3 trial Q2 ✓ Presented 36-week data from ORIGIN trial Q2 ✓ 2H Q2, Q4 Present ongoing data from ORIGIN 2 trial Present topline Phase 3 data 1H 2H BLA submission Projected launch Vera holds worldwide, exclusive rights to develop and commercialize atacicept Anticipated; based on management’s current assumptions and beliefs. 26 © 2023 VERA THERAPEUTICS, INC.
© 2023 VERA THERAPEUTICS, INC.