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Item 7.01 Regulation FD Disclosure.
On January 3, 2023, Vera Therapeutics, Inc. (the “Company”) announced positive topline 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 compiled a presentation entitled “Origin Phase 2b Study Week 24 Results”, which includes atacicept clinical summary results to date, including the data from the Phase 2b ORIGIN clinical trial referenced above. The Company will host a conference call and webcast with such presentation at 8:00 a.m. ET on January 4, 2023. The live webcast will be available on the Events & Presentations page of the Company’s website, with the recording and presentation available immediately following the event.
A copy of the 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 January 3, 2023, the Company announced positive topline data from its Phase 2b ORIGIN clinical trial of 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.
Topline results from the Phase 2b ORIGIN clinical trial
The primary endpoint analysis, change in proteinuria as evaluated by urine protein creatinine ratio (“UPCR”) at week 24 of the pooled 75/150 mg dose groups, achieved statistical significance and showed a 31% mean reduction versus baseline (p=0.037 versus placebo). Statistical significance was also achieved in the individual 150 mg dose group with a 33% mean reduction in proteinuria versus baseline (p=0.047 versus placebo) and the all-atacicept group versus placebo, as shown in Figure 1.
Figure 1. UPCR-24h % Change at Week 24
A trend towards further reductions in proteinuria was observed in the all-atacicept group versus placebo with 38% of patient data available at Week 36, as shown in Figure 2.
Figure 2. UPCR-24h % Change through Week 36
The exploratory endpoint analysis, change in estimated glomerular filtration rate (“eGFR”), showed stabilization in the all-atacicept group through Week 24, as shown in Figure 3.
Figure 3. eGFR Change through Week 24
Atacicept robustly reduced galactose-deficient IgA1 (“Gd-IgA1”) from baseline through 24 weeks, as shown in Figure 4.
Figure 4. Gd-IgA1 % Change through Week 24
Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, including a 1% discontinuation rate due to adverse events (“AEs”) and comparable rates of infection compared to placebo. Serious treatment-emergent AEs were observed in 2% of patients in all atacicept arms and in 9% of patients in the placebo arm. 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 – in which atacicept was well-tolerated.
Next Steps
As a result of these positive data, the Company plans to advance atacicept into pivotal Phase 3 development in the first half of 2023, subject to and following discussions with the U.S. Food and Drug Administration. The full data sets from the ORIGIN clinical trial will be presented at a future medical meeting.
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 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. 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,” “will,” “potential,” “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 “Origin Phase 2b Clinical Trial Week 24 Results”. | |
| 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: January 3, 2023 | ||||||
| By: | /s/ Marshall Fordyce, M.D. | |||||
| Marshall Fordyce, M.D. | ||||||
| Chief Executive Officer | ||||||
© 2023 VERA THERAPEUTICS, INC. Phase 2b Clinical Trial Week 24 Results January 2023
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 contained in this presentation 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 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. 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,” “will,” “potential,” “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 Securities and Exchange Commission. All forward-looking statements contained in this presentation 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. 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.
Agenda for Today’s Meeting Opening Remarks ORIGIN Phase 2b Topline Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP
I © 2023 VERA THERAPEUTICS, INC. Atacicept for IgA Nephropathy Self-administered subcutaneous biologic therapy in development for IgAN Targets the source of IgAN disease, Gd-IgA1 and its immune complexes, by inhibiting two cytokines, BLyS (also known as BAFF) and APRIL, important in B cell and plasma cell development and maturation IgAN = immunoglobulin A nephropathy; Gd-IgA1 = galactose-deficient IgA1; BLyS = B lymphocyte stimulator; BAFF = B cell activating factor; APRIL = a proliferation-inducing ligand. Currently being studied in a Phase 2b multinational, 36-week randomized, placebo-controlled, double-blind trial, with a 60-week open label extension Today we report positive week 24 primary results
Summary of Positive Phase 2b Week 24 Results Atacicept 150 mg dose selected for Phase 3 clinical trial, expected to initiate in 1H 2023 Atacicept met primary endpoint at week 24 Achieved statistical significance in 150 mg dose group with 33% reduction in proteinuria from baseline Trend towards further reductions in proteinuria at week 36 with available data Stable eGFR through week 24 for patients on atacicept Atacicept safety profile in IgAN patients similar to placebo Gd-IgA1 reduction of 60% at week 24 with atacicept 150 mg eGFR = estimated glomerular filtration rate.
Atacicept in IgAN: Development Program Timeline JANUS Phase 2a Topline Results1 ORIGIN Phase 2b Trial: Week 24 Topline Results ORIGIN Phase 2b Trial: Week 36 Results Initiation of Phase 3 Trial June 2020 Reported today Expected Q2 2023 Expected 1H 2023 1. Reported original analysis at Barratt J, et al. Nephrol Dial Transplant 2020, abstr MO039 and Barratt J, et al. ASN Kidney Week 2020, abstr SU-OR35; conducted by Merck KGaA.
Table of Contents Opening Remarks ORIGIN Phase 2b Topline Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP
ORIGIN Phase 2b IgAN Trial: Study Design and Objectives Multinational, randomized, placebo-controlled trial powered for 28% Δ between pooled 75/150 mg arms vs placebo ET = end of trial; RAASi = renin-angiotensin-aldosterone system inhibitor; UPCR = urine protein:creatinine ratio. Week 0 24 1° Endpoint 36 2° Endpoint Atacicept 150 mg qwk n=30 Atacicept 75 mg qwk n=30 Atacicept 25 mg qwk n=15 Placebo n=30 Atacicept 150 mg qwk Double-Blind Treatment Open-label Extension (OLE) 96/ET Endpoints Primary efficacy: UPCR-24h at week 24 Key secondary: UPCR-24h at week 36 eGFR change up to week 96 Gd-IgA1 change Safety Inclusion Criteria Patients ≥18 years old with IgAN on renal biopsy and high risk of disease progression Stable and optimized RAASi for 12 weeks UPCR-24h >0.75 g/g or UP >0.75 g per 24h eGFR ≥30 mL/min/1.73 m2 Blood pressure ≤150/90 mmHg
30% Reduction in Proteinuria is Known to be Clinically Meaningful in IgAN Patients 1. Inker LA, et al. Am J Kidney Dis 2021;78:340-9.E1; 2. Barratt Lab, University of Leicester; 3. Barratt J, et al. Kidney Int 2022;S0085-2538(22)00836-5; 4. Tarpeyo [package insert]. 2021; 5. Travere press release; Aug 16 2021. ESRD = end stage renal disease; PDUFA = Prescription Drug User Fee Amendment. 30% reduction in proteinuria at 9 months is associated with improvement of renal function in IgAN1 Reduction of 30% could delay ESRD by over 10 years2 First approved drug for IgAN, Tarpeyo™, showed ~18% proteinuria reduction at 6 months3 and 34% at 9 months,4 setting the precedent for accelerated approval in IgAN The next PDUFA date in IgAN is for Travere’s sparsentan, which showed 35% Δ active control-adjusted reduction in proteinuria at 9 months5
Multinational, Randomized, Placebo-controlled Phase 2b Trial Randomized Patients
Patient Disposition Safety data includes all post-week 24 visits available at data-cut December 23, 2022. ITT = intent to treat. 1. Discontinued to pursue elective surgery (1) and adverse event (1). 2. Initiated prohibited medication for concomitant disease. Screened, n=232 Randomized and Treated, n=116 Screen Failures, n=116 All Atacicept, n=82 Safety population, n=82 ITT population, n=82 Discontinued n=2 (2%)1 Completed Week 24 n=80 (98%) Placebo, n=34 Safety population, n=34 ITT population, n=34 Discontinued n=1 (3%)2 Completed Week 24 n=33 (97%)
Demographics and Baseline Characteristics Mean ± SD or n (%) Overall n=116 Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo 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 eGFR, mL/min/1.73 m2 63 ± 27.3 71 ± 28.7 64 ± 25.4 56 ± 22.7 66 ± 31.7 UPCR by 24h urine, g/g 1.6 ± 0.9 1.6 ± 0.8 1.7 ± 0.9 1.7 ± 1.0 1.6 ± 0.8 SGLT2i use 16 (14) 3 (19) 3 (9) 4 (12) 6 (18) SGLT2 = sodium-glucose cotransporter-2.
Atacicept Achieved Statistical Significance on Primary Endpoint (75/150 mg), 150 mg, and All Doses Combined 1. Placebo value from individual atacicept dose analysis; 2. Primary analysis. p-value and % change from baseline were estimated from the mixed effect model with repeated measurement (MMRM), including change from baseline in natural log transformed UPCR as the dependent variable, log transformed baseline UPCR, baseline eGFR category, treatment, visit, treatment and visit interaction terms as fixed effects, and patient as a random effect. UPCR-24h % Change at Week 24 p=0.047 p=0.037 Atacicept p=0.026 1 Mean ± SE % Change from Baseline in UPCR-24h Placebo, n=34 75/150 mg2, n=64 150 mg, n=32 All, n=79 Atacicept 150 mg dose selected for Phase 3 clinical trial
n= Placebo 34 34 34 12 All Atacicept 82 81 79 32 Trend Towards Further Proteinuria Reduction in All-Atacicept Group vs Placebo (38% of Patient Data at Week 36) p-value and % change from baseline were estimated from MMRM, including change from baseline in natural log transformed UPCR as the dependent variable, log transformed baseline UPCR, baseline eGFR category, treatment, visit, treatment and visit interaction terms as fixed effects, and patient as a random effect. UPCR-24h % Change Through Week 36 Mean ± SE % Change from Baseline in UPCR-24h Week p=0.032 -5 -36
Stable eGFR Through Week 24 in All Atacicept Group n= Placebo 34 34 34 34 34 All Atacicept 82 81 82 81 79 Mean eGFR change from baseline +3 mL/min at week 24 Similar results for atacicept 150 mg alone As expected, week 24 timepoint is too early to observe eGFR decline in placebo eGFR Change Through Week 24 Mean ± SD Change from Baseline in eGFR, mL/min/1.73 m2 Week
Robust Reductions in Gd-IgA1 Through Week 24 n= Placebo 33 33 33 33 Atacicept 25 mg 16 16 16 15 Atacicept 75 mg 33 33 33 32 Atacicept 150 mg 32 32 30 29 Gd-IgA1 % Change Through Week 24 Mean ± SD % Change from Baseline in Gd-IgA -60 -56 -36 2 Week
Dose-dependent Reductions in Serum IgG, IgA, and IgM Through Week 24 n= Placebo 34 34 34 34 Atacicept 25 mg 16 16 16 15 Atacicept 75 mg 33 33 33 32 Atacicept 150 mg 33 33 32 32 34 34 34 34 16 16 16 15 33 33 33 32 33 33 32 31 34 34 34 34 16 16 15 14 33 33 28 23 33 32 22 19 IgG IgA IgM Mean ± SD % Change from Baseline 1 -15 -30 -34 Week -2 -29 -49 -59 Week 0 -51 -64 -70 Week
No Study Drug Discontinuation Due to IgG Levels on Atacicept No patient had study drug discontinuation, interruption, or sustained IgG <3 g/L (<300 mg/dL) through week 24 *Per ORIGIN protocol, if serum IgG was <300 mg/dL on two consecutive timepoints at least 28 days apart, the study drug was discontinued. One patient (atacicept 75 mg) below study-defined IgG threshold of <3 g/L at 2.99 g/L; >3 g/L upon repeat measurement; study drug continued weekly; no infections reported in this patient. IgG Mean ± SD, mg/dL Week Placebo Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg *
Patients, n (%) Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo n=34 TEAEs 11 (69) 24 (73) 25 (76) 27 (79) Study drug-related TEAEs1 6 (38) 16 (48) 18 (55) 14 (41) Serious TEAEs 1 (6) 1 (3) 0 3 (9) TEAEs leading to study drug discontinuation 0 0 1 (3)2 0 Deaths 0 0 0 0 Treatment-Emergent Adverse Events 1. Majority of study drug-related TEAEs were injection site reactions; one contributed to drug discontinuation 2. 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.
Infections Were Balanced Between Atacicept and Placebo Patients, n (%) Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo n=34 Infections (all mild or moderate; no severe) 6 (38) 16 (48) 12 (36) 11 (32) Occurring in >1 patient COVID-191 4 (25) 9 (27) 8 (24) 6 (18) Upper respiratory tract infection 0 3 (9) 2 (6) 0 Viral infection 0 2 (6) 0 2 (6) Nasopharyngitis 0 1 (3) 1 (3) 1 (3) Urinary tract infection 2 (13) 1 (3) 0 0 Influenza 0 1 (3) 0 1 (3) Tonsillitis 1 (6) 1 (3) 0 0 1. One patient with COVID-19 was hospitalized and recovered.
Summary of Clinical Safety Data 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 serious AEs in atacicept 150 mg group No patient had study drug discontinuation or interruption due to hypogammaglobulinemia
Table of Contents Opening Remarks Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP ORIGIN Phase 2b Topline Results
Summary of Positive Phase 2b Week 24 Results Atacicept 150 mg dose selected for Phase 3 clinical trial, expected to initiate in 1H 2023 Atacicept met primary endpoint at week 24 Achieved statistical significance in 150 mg dose group with 33% reduction in proteinuria from baseline Trend towards further reductions in proteinuria at week 36 with available data Stable eGFR through week 24 for patients on atacicept Atacicept safety profile in IgAN patients similar to placebo Gd-IgA1 reduction of 60% at week 24 with atacicept 150 mg
Atacicept Phase 2 Week 24 Data in Context Multinational, Randomized, Placebo-controlled Trials Drug Tarpeyo™ (approved) Atacicept Sibeprenlimab Sparsentan Dose Regimen & Administration 16 mg oral 9-month duration only 150 mg SC qwk selected for Ph 3 (1 x 1 mL injection) 2–8 mg/kg IV (Ph 2) 400 mg SC (Ph 3) (1 x 2 mL injection) 200 or 400 mg oral Mechanism Corticosteroids can modulate B-cell numbers and activity Dual BLyS/APRIL inhibition APRIL inhibition only ETaR/AT1R antagonism Proteinuria Change Week 24 ~-18% vs ~-4% placebo1 -33% vs -7% placebo 28% Δ Not reported Not reported Week 36 -34% vs -5% placebo 31% Δ2 To come 43% Δ pooled IV data3 SC efficacy data not established -50% vs -15% control 35% Δ4 Gd-IgA1 Change from Baseline ~-34% week 365 -60% week 24 Not reported N/A Safety Data Most AEs that occurred at a greater incidence vs placebo were consistent with hypercortisolism Comparable to placebo No placebo comparison reported Not reported 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. 1. Barratt J, et al. Kidney Int 2022;S0085-2538(22)00836-5; 2. Tarpeyo [package insert]. 2021; 3. Kooienga L, et al ASN Kidney Week 2022. Data presented at “month 9” assumed to be at week 36; 4. Travere press release; 2021. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-positive-topline-interim-results; 5. Molyneux K, et al ASN Kidney Week 2022. ETaR = endothelin-1 type A receptor; AT1R = angiotensin II type 1 receptor.
No RCT safety data reported RCT safety data available Atacicept Has Well Characterized Safety Database vs APRIL-Only Approaches 1. Patients administered ≥1 dose of listed medication as of November 2022 review of published literature; 2. Based on published results involving safety per Levy et al Lupus 2021; excludes other clinical studies and post-marketing/commercial experience; 3. Atacicept Integrated Safety Analysis by Gordon et al Rheumatol Adv Pract 2019 plus IgAN JANUS and ORIGIN studies; 4. Two Ph1 healthy volunteer studies (Mathur et al Kidney Int Rep 2022, Zhang et al ASN 2021 poster), Ph2 ENVISION study in IgAN (Kooienga et al ASN 2022 poster); 5. Two Ph1 healthy volunteer studies (Chinook 4th CKD Summit 2022), Ph1/2 IgAN study (Barratt et al ASN 2022 poster), Ph1/2 multiple myeloma study (Bensinger et al ASCO 2019 abstract). RCT = randomized controlled trial. 7,000 BLyS/APRIL BLyS-only Published clinical experience Commercial experience not included b2 t3 b4 15 Patients (approx.)1 APRIL-only
Atacicept Is Well Characterized Going Into Phase 3 vs APRIL-Only Approaches 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. 1. Kooienga L, et al. ASN Kidney Week 2022. Data presented at “month 9” assumed to be at week 36; 2. Barratt J, et al. ASN Kidney Week 2022. Drug Atacicept Sibeprenlimab BION-1301 Dose Regimen & Administration 150 mg SC qwk selected for Ph 3 (1 x 1 mL injection) 2–8 mg/kg IV (Ph 2) 400 mg SC monthly (Ph 3) (1 x 2 mL injection) 450 mg IV q2wk (Ph 2) 600 mg SC q2wk (Ph 2, Ph 3) (2 x 2 mL injection) Mechanism Dual BLyS/APRIL inhibition APRIL inhibition only APRIL inhibition only Global RCT ✓ ✓ ✗ N (total randomized & treated for Ph 2 study) 116 1551 342 Baseline UPCR, g/g mean 1.7 Not reported median 0.5 Cohort 1 median 0.8 Cohort 2 Proteinuria Change Week 24 -33% vs -7% placebo 28% Δ Not reported -49% Cohort 1, -54% Cohort 2 vs baseline, n=17 No placebo reported Week 36 To come 43% Δ pooled IV data SC efficacy data not established Not reported Gd-IgA1 Change from Baseline -60% week 24, n=29 Not reported -60 to -65% week 24, n=7 Safety Data Comparable to placebo No placebo comparison reported No placebo comparison reported
Endpoints Primary efficacy: UPCR-24h at week 36 to support potential accelerated approval Key secondary: eGFR change up to week 104 Safety Initiation of Phase 3 Pivotal Trial Expected in 1H 2023 Atacicept Once Weekly SC Injection Formulation in Phase 3, Same as Phase 2b Week 0 Atacicept 150 mg qwk Placebo Atacicept 150 mg qwk Double-Blind Treatment Open-label Extension (OLE) 156 36 1° Endpoint 104 2° Endpoint Inclusion Criteria Patients ≥18 years old with IgAN on renal biopsy and high risk of disease progression UPCR-24h 1.0 g/g or UP 1.0 g per 24h eGFR ≥30 mL/min/1.73 m2 Stable and optimized RAASi for 12 weeks Use of SGLT2 inhibitors allowed Blood pressure ≤150/90 mmHg Regulatory Update FDA meeting in Q4 2022 discussed preliminary alignment on Phase 3 study design to enable start in 1H 2023 Final trial design pending FDA concurrence
Potential Value Creation Over Next 18 Months Program Indication Catalyst 2022 2023 2024+ Atacicept IgA Nephropathy Presented data on Gd-IgA1, anti-Gd-IgA1, and immune complexes from Phase 2a JANUS trial Completed enrollment in Phase 2b ORIGIN trial Present 24-week data from ORIGIN trial Present 36-week data from ORIGIN trial Initiate Phase 3 trial Present topline Phase 3 Lupus Nephritis Initiated Phase 3 COMPASS trial Present topline COMPASS data MAU868 BK Viremia in Renal Transplant Presented full results from Phase 2 trial Initiate Phase 2b or 3 trial Vera holds worldwide, exclusive rights to develop and commercialize atacicept and MAU868
Table of Contents Opening Remarks Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP ORIGIN Phase 2b Topline Results
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