BRISBANE, Calif., May 28, 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 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. The designation reflects the FDA's determination that, based on an assessment of data from the Phase 2b ORIGI ...

BRISBANE, Calif., May 25, 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 presentations from its Phase 2b ORIGIN trial of atacicept in immunoglobulin A nephropathy (IgAN), showing that atacicept stabilized kidney function through 72 weeks and led to rapid improvements in hematuria. These data were presented at ...

Core Insights - Vera Therapeutics announced positive results from its Phase 2b ORIGIN trial of atacicept for immunoglobulin A nephropathy (IgAN), demonstrating stabilized kidney function and rapid improvements in hematuria over 72 weeks [1][2][4] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [19] Clinical Trial Results - The Phase 2b ORIGIN trial showed that participants receiving atacicept for 72 weeks had stable estimated glomerular filtration rate (eGFR) and significant reductions in Gd-IgA1, hematuria, and urine protein to creatinine ratio (UPCR) [2][12] - Atacicept treatment resulted in hematuria resolution in 80% of participants compared to 5% in the placebo group, with significant improvements observed as early as 4 weeks after treatment initiation [4][12] - The trial met its primary and key secondary endpoints, indicating statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR compared to placebo [12] Upcoming Milestones - The company plans to present full 96-week data from the Phase 2b ORIGIN trial in the fourth quarter of 2024 and expects to complete enrollment for the pivotal Phase 3 ORIGIN 3 trial by the third quarter of 2024 [14][20] Safety Profile - The cumulative safety profile of atacicept was comparable to the randomized period, with a retention rate of 91% through 72 weeks, supporting its potential for long-term disease modification in IgAN [2][12] Disease Background - IgAN, also known as Berger's disease, is a serious autoimmune disease of the kidney that can lead to end-stage kidney disease in up to 50% of patients, highlighting the high unmet medical need for effective treatments [17]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-2744449 (State or other jurisd ...

Exhibit 99.1 Vera Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results BRISBANE, Calif., May 9, 2024 – 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 first quarter ended March 31, 2024. "This quarter, we shared results from our Phase 2b clinical trial th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-2744449 (State or other jurisdiction ...

Clinical Trial Progress - Presented positive 72-week data from the Phase 2b ORIGIN clinical trial, showing no loss of kidney function over the duration of treatment[3] - Phase 3 ORIGIN 3 clinical trial of atacicept for IgAN is on track, with topline data expected in the first half of 2025[3][12] - The Phase 2b ORIGIN trial of atacicept in IgAN showed statistically significant reductions in proteinuria and stabilized eGFR at weeks 24, 36, and 72[14] Financial Performance - Reported a net loss of $96.0 million for the year ended December 31, 2023, compared to a net loss of $89.1 million in the previous year[10] - Net cash used in operating activities was $92.2 million for the year ended December 31, 2023, compared to $67.6 million in the previous year[10] - Research and development expenses increased to $78.2 million in 2023 from $69.0 million in 2022[6] Financing and Cash Position - Completed $287.5 million financing, extending the company's cash runway through potential approval and commercial launch[3] - Reported $160.7 million in cash, cash equivalents, and marketable securities as of December 31, 2023[11] - Completed an upsized public offering of Class A common stock with gross proceeds of approximately $287.5 million in February 2024[12] Product Pipeline - MAU868, a potential first-in-class monoclonal antibody, has the potential to neutralize BK virus infection, with no approved treatments currently available[15]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Delaware 81-2744449 (State or other ju ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 For the transition period from to Commission File Number: 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-2744449 (State or other jurisdiction of incorporation or organization) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) ...

1. One patient with COVID-19 was hospitalized and recovered. 28 © 2023 VERA THERAPEUTICS, INC. Ability to leverage ORIGIN worldwide sites ORIGIN Subgroup Analyses Inform Phase 3 Design to Maximize Competitive Positioning 2020 2023 2024 2025 Phase 2b Trial Ongoing Results Corporate Presentation © 2023 VERA THERAPEUTICS, INC. 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 ...