nephrin

Participants with nephrotic syndrome in NEPTUNE Match will receive information about the PIONEER study and other clinical trials based on their individual disease characteristics;PIONEER study expands the investigation of atacicept into multiple autoimmune glomerular diseases, supported by the disease-modifying potential of BAFF/APRIL dual inhibition; BRISBANE, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, is partnering with the University of Michigan on the Nephrotic Syndrome Study Network (NEPTUNE) Match project. NEPTUNE is a multicenter consortium of more than 30 North American academic centers that conducts clinical and translational research on kidney diseases that present as nephrotic syndrome (NS), including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). Through NEPTUNE Match, participants and their nephrologists receive information about clinical trials targeting mechanisms that match the participant’s molecular disease characteristics. This evidence-based approach to selecting clinical trials is aimed at improving treatment response and more successful outcomes across trials. In partnership with Vera Therapeutics, NEPTUNE Match will inform potential participants about the PIONEER study. PIONEER represents the expansion of the atacicept development program into multiple autoimmune kidney indications based on the presence of antibodies to glomerular antigens. In addition to a broader population of IgAN, the PIONEER study will evaluate the efficacy and safety of atacicept in anti-PLA2R podocytopathies (pMN) and anti-nephrin podocytopathies (FSGS and MCD). NEPTUNE Match will help participants with anti-PLA2R and anti-nephrin antibodies learn about the PIONEER study and support an informed decision about clinical trial participation. “Based on the positive long-term data from the ORIGIN Phase 2b study presented at ASN Kidney Week, we’re excited to offer a clinical trial with atacicept to patients with nephrotic syndrome who have biomarkers that may predict a positive response to B cell modulation,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “In addition to providing patients with crucial resources and education about their individual disease biology, NEPTUNE Match will support the enrollment of eligible participants for the PIONEER study. We look forward to announcing initial data from PIONEER in 2025.” “We are thrilled to partner with Vera Therapeutics in NEPTUNE Match. With the new, disruptive insights into pathobiology of NS gleaned in NEPTUNE, we can now target specific antibody-mediated glomerular damage. Testing the efficacy of atacicept among patients identified with active, antibody-mediated disease will truly bring the latest science meaningfully back to our study participants and patients who are in urgent need of new therapies,” stated Matthias Kretzler, M.D., Warner Lambert-Parke Davis Professor of Medicine, University of Michigan and principal investigator of NEPTUNE. About NEPTUNEThe Nephrotic Syndrome Study Network (NEPTUNE) is a multi-site collaborative study that conducts clinical and translational research on FSGS, MCD, and MN that present as NS, pediatric incident NS without a diagnostic kidney biopsy and Alport syndrome. With the NEPTUNE Match precision medicine research platform, NEPTUNE connects patients’ individual disease mechanisms to ongoing drug trials to ensure the right patients participate in the right trial at the right time. For more information, visit NEPTUNE-STUDY.org. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com. About AtaciceptAtacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. Forward-looking StatementsStatements contained in this press release 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, Vera’s expectations regarding the expansion of its development pipeline for atacicept, atacicept’s potential to be a best-in-class treatment, Vera’s expectations regarding the potential for B cell modulation through BAFF/APRIL dual inhibition to transform the treatment landscape for certain autoimmune diseases, Vera’s plans to initiate the PIONEER study in 2025, Vera’s anticipated presentations of clinical trial data, and Vera’s product candidates, strategy, and regulatory matters. 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 “substantial,” “will,” “may,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’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, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. 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. Vera 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. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

Presented positive 96-week long-term eGFR stabilization data from ORIGIN Ph 2b clinical trial of atacicept in IgAN in a late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week 2024 with simultaneous peer-reviewed publication in the Journal of the American Society of Nephrology (JASN)Completed enrollment of the primary endpoint cohort in the pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN; topline data expected in Q2 2025Announced expanded atacicept development program in the broad IgAN population and in multiple autoimmune kidney diseasesCompleted an equity offering with gross proceeds of approximately $345 million ahead of potential regulatory submission and commercial launch BRISBANE, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the third quarter ended September 30, 2024. “We have made substantial progress advancing our clinical development program for atacicept in 2024. The positive data announced throughout the year, including the 96-week data from the ORIGIN trial presented in a late-breaking oral presentation at ASN’s Kidney Week 2024 along with simultaneous publication in JASN, have positioned atacicept as a potential best-in-class disease-modifying treatment option for patients with IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Our mission is to bring safe and effective therapies to patients with high unmet needs. To this end, we are on track to deliver topline results of our Phase 3 pivotal trial in Q2 2025. In addition, we recently announced plans to expand the development of atacicept into the broad profile of IgAN and in multiple other autoimmune kidney diseases. The PIONEER study will evaluate the use of atacicept in treating IgAN patients that do not meet the inclusion/exclusion criteria of ORIGIN 3, as well as adjacent antibody-mediated autoimmune conditions such as membranous nephropathy (MN) and focal segmental glomerulosclerosis (FSGS). The PIONEER study recognizes that atacicept has true pipeline-in-a-product potential.” Third Quarter and Recent Business Highlights Presented positive data showing eGFR stabilization at 96 weeks in ORIGIN Ph 2b clinical trial of atacicept in IgAN at the American Society of Nephrology Kidney Week 2024 and in manuscript form in JASNCompleted enrollment of the primary endpoint cohort in the pivotal Phase 3 ORIGIN 3 trial of atacicept in IgANExpanded atacicept development program in multiple autoimmune kidney diseases at its R&D Day in New York, joined by academic leaders Drs. Jonathan Barratt, Richard Lafayette, Brad RovinAppointed industry veteran Matt Skelton as Executive Vice President, CommercialCompleted a public equity offering of Class A common stock with gross proceeds totaling approximately $345 million, further bolstering balance sheet ahead of potential regulatory submission and commercial launch Major Upcoming Milestones Pivotal ORIGIN 3 trial on track to announce topline results in Q2 2025, with planned BLA submission to the U.S. FDA later in the yearPlan to initiate the ORIGIN Extend study in Q4 2024, providing ORIGIN participants with extended access to atacicept and capturing longer-term safety and efficacy dataPlan to initiate the PIONEER trial in 2025, which will evaluate the efficacy and safety of atacicept in expanded IgAN populations and anti-PLA2R and anti-nephrin podocytopathies Financial Results for the Quarter Ended September 30, 2024For the quarter ended September 30, 2024, the company reported a net loss of $46.6 million, or a net loss per diluted share of $0.85, compared to a net loss of $20.1 million, or a net loss per diluted share of $0.45, for the same period last year. During the nine months ended September 30, 2024, net cash used in operating activities was $95.5 million, compared to $67.0 million for the same period last year. Vera reported $353.3 million in cash, cash equivalents, and marketable securities as of September 30, 2024. Subsequent to September 30, 2024, the Company strengthened its balance sheet upon completing an underwritten public offering of its Class A common stock with gross proceeds of approximately $345 million, before deducting underwriting discounts and commissions and estimated offering expenses. The Company believes its balance sheet will be sufficient to fund operations through the potential approval and U.S. commercial launch of atacicept. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About MAU868MAU868, a potential first-in-class monoclonal antibody, has the potential to neutralize infection by blocking BKV virions from binding to host cells. BKV is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant. It is a leading cause of kidney transplant loss and transplant-associated morbidity; there are currently no approved treatments for BKV. Vera holds an exclusive worldwide license from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., for the development and commercialization of MAU868 in all indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BKV, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com Forward-looking StatementsStatements contained in this press release regarding Vera’s expectations regarding the offering are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon Vera’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, Vera’s expectations regarding the completion of the offering. 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. Vera 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. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com VERA THERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 (unaudited) (unaudited)Operating expenses: Research and development$40,314 $16,100 $92,825 $57,440 General and administrative 9,487 5,656 25,431 17,544 Total operating expenses 49,801 21,756 118,256 74,984 Loss from operations (49,801) (21,756) (118,256) (74,984)Other income, net 3,169 1,652 9,533 4,649 Net loss$(46,632) $(20,104) $(108,723) $(70,335)Change in unrealized gains and losses on marketable securities$1,494 $67 $793 $149 Comprehensive loss$(45,138) $(20,037) $(107,930) $(70,186)Net loss per share attributable to common stockholders, basic and diluted$(0.85) $(0.45) $(2.03) $(1.67)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 54,898,297 44,363,419 53,537,910 42,124,779 VERA THERAPEUTICS, INC.Condensed Balance Sheets(in thousands) September 30, December 31, 2024 2023 (unaudited) Assets Current assets: Cash, cash equivalents and marketable securities$353,309 $160,716 Prepaid expenses and other current assets 10,822 11,307 Total current assets 364,131 172,023 Operating lease right-of-use assets 3,921 2,949 Other noncurrent assets 508 574 Total assets$368,560 $175,546 Liabilities and stockholders' equity Current liabilities: Accounts payable$4,602 $11,118 Operating lease liabilities 1,872 2,436 Accrued expenses and other liabilities, current 19,990 8,749 Total current liabilities 26,464 22,303 Long-term debt 50,470 49,877 Operating lease liabilities, noncurrent 2,568 1,395 Accrued expenses and other liabilities, noncurrent - 286 Total liabilities 79,502 73,861 Stockholders' equity Common stock 55 44 Additional paid-in-capital 705,784 410,492 Accumulated other comprehensive income 1,044 251 Accumulated deficit (417,825) (309,102)Total stockholders' equity 289,058 101,685 Total liabilities and stockholders' equity$368,560 $175,546

Long-term improvements observed in the quartet of findings defining disease modification supports atacicept’s potential to prevent kidney failure in patients with IgAN;Long-term results from the ORIGIN Phase 2b study were simultaneously published in the Journal of the American Society of Nephrology;Company will host an investor call and webcast on Monday October 28 at 8:00 AM ET BRISBANE, Calif., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced data from its ORIGIN Phase 2b trial of atacicept in immunoglobulin A nephropathy (IgAN) that show stabilized kidney function through 96 weeks of long-term follow-up. These data were presented in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024 in San Diego, California, and simultaneously published in a manuscript in the Journal of the American Society of Nephrology. “The 96-week results from the ORIGIN Phase 2b study demonstrated sustained and substantial reductions in Gd-IgA1, hematuria and proteinuria as measured by UPCR with long-term stabilization of eGFR,” said Jonathan Barratt, MD, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester. “Converting patients with IgAN from an eGFR profile of unrelenting decline to a profile consistent with the general population without kidney disease is a differentiated and compelling finding. Collectively, the data support the potential of atacicept to modify the natural history of the disease and prevent kidney failure during the lifetime of patients with IgAN.” “We are excited to present these long-term efficacy and safety data from the ORIGIN Phase 2b study, which further demonstrate atacicept’s potential to address the underlying pathogenesis of IgAN. The stabilization of kidney function through two years—the longest duration of data among B cell modulators to date—positions atacicept as a potential best- and first-in-class treatment option for patients with IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We look forward to announcing expected topline results from the Phase 3 ORIGIN 3 trial in Q2 2025, with planned BLA submission to the U.S. FDA later in the year.” Over 96 weeks, participants treated with atacicept demonstrated a -66% reduction in galactose-deficient IgA1 (Gd-IgA1), resolution of hematuria in 75% of participants, a -52% reduction in proteinuria, and a mean annualized estimated glomerular filtration rate (eGFR) slope of -0.6 mL/min/1.73m2/year. The cumulative generally favorable safety profile of atacicept remained consistent with that observed during the randomized period, with a 90% completion rate of atacicept treatment. Figure 1. ORIGIN Phase 2b long-term 96-week results with atacicept was consistent with disease-modifying IgAN profile The Company believes these data support the potential for atacicept to offer long-term, comprehensive IgAN disease modification and provide further confidence in the ongoing pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN. The Company will host an investor call and webcast to discuss the data update on Monday, October 28, at 8:00 AM ET. The live webcast will be available on the Company’s Investor Calendar at https://ir.veratx.com/news-events/investor-calendar, with the recording and presentation available immediately following the event. The Kidney Week 2024 presentation and posters are available on the Company’s website at https://ir.veratx.com/news-events/presentations. Upcoming milestones: ORIGIN Extend – plan to initiate a study in Q4 2024 that will provide ORIGIN participants with extended access to atacicept prior to commercial availability in their region, as well as an opportunity to capture longer-term data.Pivotal ORIGIN 3 trial on track to announce topline results in Q2 2025, with planned BLA submission to the U.S. FDA later in the yearPIONEER Study – plan to initiate a study in 2025 that will evaluate the efficacy and safety of atacicept in: Expanded IgAN populations – The first set of cohorts will include adults with low kidney function (eGFR 20 to <30 mL/min/1.73 m2), low (UPCR <1.0 g/g) or high proteinuria (UPCR ≥5.0 g/g) or IgAN recurrence after kidney transplant; adolescents at high risk of progression (UPCR ≥0.3 g/g); as well as adolescents and adults with IgA vasculitis nephritis.Anti-PLA2R and anti-nephrin podocytopathies – The PIONEER study will expand to additional autoimmune glomerular diseases characterized by the presence of antibodies to glomerular antigens, including primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease. About the Phase 2b ORIGIN clinical trialThe Phase 2b ORIGIN clinical trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of atacicept in 116 patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of a renin-angiotensin-aldosterone system inhibitor for at least 12 weeks that is the maximum labeled or tolerated dose. The Phase 2b ORIGIN clinical trial evaluated three dose strengths of atacicept versus placebo, administered weekly by prefilled syringe. Patients were randomized 2:2:1:2 to atacicept 150 mg, atacicept 75 mg, atacicept 25 mg or matching placebo. Upon completion of the 36-week blinded treatment period, all patients were offered open-label atacicept 150 mg for an additional 60 weeks. The primary endpoint was the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) at week 24, and the key secondary endpoint was the change in proteinuria as evaluated by UPCR at week 36. Additional exploratory endpoints include change in proteinuria as evaluated by UPCR at weeks 12, 48, and 96; change in eGFR; change in serum immunoglobulin levels, and change in serum Gd-IgA1 levels; safety and tolerability; and serum pharmacokinetics. The trial met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through week 36. The safety profile was comparable between atacicept and placebo. For more information about the Phase 2b ORIGIN clinical trial, please visit www.clinicaltrials.gov. About the Phase 3 ORIGIN 3 clinical trialThe ORIGIN 3 clinical trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of renin-angiotensin system inhibitors for at least 12 weeks that is the maximum labeled or tolerated dose. The objectives of the trial are to determine the effect of atacicept on proteinuria and preservation of kidney function compared to placebo. For more information about the ORIGIN 3 clinical trial, please visit http://www.clinicaltrials.gov. About AtaciceptAtacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 72 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BKV, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com. Forward-looking StatementsStatements contained in this press release 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, Vera’s expectations regarding the expansion of its development pipeline for atacicept, atacicept’s potential to be a best-in-class treatment for patients with IgAN, Vera’s expectations regarding the potential for B cell modulation through BAFF/APRIL dual inhibition to transform the treatment landscape for certain autoimmune diseases, Vera’s plans to initiate the ORIGIN Extend study in the fourth quarter of 2024 providing extended access to atacicept to ORIGIN participants, Vera’s plans to initiate the PIONEER study in 2025, Vera’s anticipated presentations of clinical trial data, including the announcement of topline results from the Phase 3 ORIGIN 3 trial in the second quarter of 2025, Vera’s plans for a BLA filing for atacicept in 2025 and Vera’s product candidates, strategy, and regulatory matters. 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 “believes,” “expects,” “plan,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’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, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. 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. Vera 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. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e8cbc495-7104-43c9-a2ed-6d0e38ad21ae