BRISBANE, Calif., Oct. 22, 2025 (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 it will host an investor call and webcast at 4:30 PM ET on Thursday, November 6, 2025 to review the data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) presented at the morning plenary ses ...

BRISBANE, Calif., Oct. 17, 2025 (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 data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be delivered as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology ...

Core Insights - Vera Therapeutics, Inc. granted inducement awards to eight new employees, including non-qualified stock options for 99,000 shares and restricted stock units (RSUs) for 48,200 shares under the 2024 Inducement Plan [1][2] Group 1: Inducement Awards - The stock options have an exercise price of $20.45, which is the closing trading price on August 4, 2025 [2] - Stock options will vest over four years, with 25% vesting on the first anniversary and the remaining shares vesting monthly over the next 36 months [2] - RSUs will also vest over four years, with 25% vesting on each anniversary of August 20, 2025 [2] Group 2: Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on treatments for serious immunological diseases [3] - The lead product candidate, atacicept, is designed to block BAFF and APRIL, which are involved in autoimmune diseases like immunoglobulin A nephropathy and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody targeting BK virus infections, and holds global rights to atacicept and MAU868 [3]

Core Viewpoint - Vera Therapeutics reported a widening net loss of $76.5 million for Q2 2025, significantly exceeding analyst expectations, while also achieving revenue of $76.5 million, indicating increased spending as the company approaches regulatory filing for its lead drug candidate [1][5][6]. Financial Performance - The GAAP net loss increased by approximately 127% year-over-year, from $33.7 million in Q2 2024 to $76.5 million in Q2 2025 [2][5]. - The loss per share (GAAP) was $1.20, a significant increase from $0.62 in Q2 2024, reflecting a rapid rise in spending [6]. - Research and development expenses nearly doubled to $58.2 million from $29.3 million in Q2 2024, driven by costs associated with late-stage clinical trials and preparations for commercialization [2][6]. Business Overview - Vera Therapeutics is focused on developing therapies for serious immunological diseases, particularly Immunoglobulin A Nephropathy (IgAN), with its lead drug candidate, atacicept, designed to modify the disease course [3][9]. - The company is preparing for a pivotal Phase 3 ORIGIN trial outcome, which is crucial for a future submission to the FDA for accelerated approval [4][9]. Clinical Developments - Positive results from the ORIGIN Phase 3 trial showed a 46% reduction in proteinuria at 36 weeks, with a favorable safety profile for atacicept, reinforcing plans for a Biologics License Application (BLA) submission in Q4 2025 [7][9]. - Vera has initiated the PIONEER study to test atacicept in other kidney diseases, indicating ambitions to expand the drug's impact and revenue potential [8][12]. Strategic Initiatives - The company is building a specialized commercial team with nephrology expertise to facilitate the transition from clinical success to market adoption [10]. - Vera secured a new credit facility of up to $500 million, alongside $556.8 million in cash and equivalents, to support operations through the anticipated approval and launch of atacicept [11]. Future Outlook - Management emphasized near-term milestones, including the planned BLA submission for atacicept and expected initial results from the PIONEER trial later in the year [13][14]. - The company does not currently pay a dividend, focusing resources on advancing its clinical and commercial strategies [14].

Core Insights - Vera Therapeutics reported significant clinical results from the ORIGIN 3 trial for atacicept, showing potential as a first dual BAFF/APRIL inhibitor for IgA Nephropathy (IgAN) [2][6] - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA for accelerated approval in Q4 2025, with a potential commercial launch in 2026 [2][6] Business Highlights - The ORIGIN 3 trial demonstrated a 46% reduction in proteinuria for atacicept-treated participants, achieving a statistically significant 42% reduction compared to placebo [7] - The safety profile of atacicept appears favorable and comparable to placebo, with full enrollment in the ORIGIN 3 trial completed [7] - Vera initiated the PIONEER trial to evaluate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases [6][7] Financial Results - For Q2 2025, Vera reported a net loss of $76.5 million, compared to a net loss of $33.7 million in Q2 2024, with a net loss per diluted share of $1.20 [5] - Net cash used in operating activities for the first half of 2025 was $109.2 million, up from $58.6 million in the same period last year [5] - As of June 30, 2025, Vera had $556.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through potential approval and commercial launch of atacicept [8] Anticipated Upcoming Milestones - BLA submission for atacicept expected in Q4 2025, with full primary endpoint results from the ORIGIN 3 trial to be presented at a medical congress in the same quarter [6][7] - Initial results from the PIONEER Phase 2 basket trial are also expected in Q4 2025, with the ORIGIN 3 study completion anticipated in 2027 [6][7]

Company Overview - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [3] - The company's mission is to advance treatments that target the source of immunological diseases to change the standard of care for patients [3] Product Candidates - Vera's lead product candidate is atacicept, a fusion protein administered as a subcutaneous injection once weekly, which blocks B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) [3] - Atacicept is aimed at treating autoimmune diseases such as IgAN (Berger's disease) and lupus nephritis by reducing autoantibodies [3] - The company is also developing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infection, which can have severe consequences in settings like kidney transplants [3] Licensing and Partnerships - Vera retains all global developmental and commercial rights to both atacicept and MAU868 [3] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein targeting BAFF and APRIL, known as VT-109, which has wide therapeutic potential across B cell mediated diseases [3] Upcoming Events - The management team will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference from June 9 – 11, 2025 [1] - The fireside chat is scheduled for June 11, 2025, at 3:15 PM EDT, with a webcast available for 90 days [2]

Core Viewpoint - Vera Therapeutics has secured a new credit facility of up to $500 million to support its growth and development of treatments for serious immunological diseases, particularly focusing on the pivotal atacicept program for IgA nephropathy [1][2][3] Group 1: Credit Facility Details - The new credit facility replaces an existing $50 million facility and includes an initial funding of $75 million expected on June 4, 2025 [1] - The refinancing reduces interest expenses significantly, lowering the borrowing cost by 320 basis points, with a new interest rate of 1-month SOFR plus 4.95%, subject to a SOFR floor of 3.75% [5] - The facility provides an additional $450 million of discretionary incremental capacity available in five tranches, allowing Vera to draw funds based on specific milestones and approvals [5] Group 2: Strategic Implications - The new credit facility enhances Vera's financial flexibility, allowing for an extended interest-only period of up to 42 months and no principal payments required in 2026 [5] - The refinancing is expected to improve Vera's ability to manage its capital structure efficiently and support the commercial launch of atacicept [2][5] - Vera aims to submit a Biologics License Application (BLA) to the FDA in Q4 2025, with potential approval and commercial launch of atacicept in 2026 [2][3] Group 3: Company Overview - Vera Therapeutics is focused on developing transformative treatments for serious immunological diseases, with its lead product candidate being atacicept, which targets B-cell Activating Factor (BAFF) and APRIL [4] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, aimed at treating B cell-mediated diseases [4][6] - Vera is also developing MAU868, a monoclonal antibody designed to neutralize BK virus infections, which can have severe consequences in kidney transplant settings [4][6]

Core Insights - Vera Therapeutics announced that the ORIGIN Phase 3 trial of atacicept for immunoglobulin A nephropathy (IgAN) met its primary endpoint, demonstrating significant efficacy in reducing proteinuria [1][7]. Efficacy Results - Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio (UPCR), and a 42% reduction compared to placebo at week 36 (p<0.0001) [2][7]. - Other prespecified endpoints showed results consistent with or better than those observed in the ORIGIN Phase 2b trial [2][7]. Safety Profile - The safety profile of atacicept was favorable and comparable to that of the placebo [2][7]. Regulatory Plans - Vera plans to share these results with the FDA and intends to submit a Biologics License Application (BLA) for atacicept in IgAN in the fourth quarter of 2025, potentially allowing for US approval and commercial launch in 2026 [4][7]. Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN, with participants receiving either atacicept 150 mg or placebo [5][7]. - The trial continues to evaluate changes in kidney function over two years, with completion expected in 2027 [5][7]. Company Vision - Vera Therapeutics aims to advance the standard of care in IgAN and other autoimmune kidney diseases, aspiring to evolve kidney medicine practices [4][12].

Core Insights - Vera Therapeutics is approaching a significant milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, which may lead to a Biologics License Application (BLA) submission to the FDA in the second half of 2025, potentially allowing for approval and commercial launch in 2026 [2][4][8] - The company reported a net loss of $51.7 million for Q1 2025, an increase from a net loss of $28.4 million in Q1 2024, with net cash used in operating activities rising to $54.4 million from $33.8 million year-over-year [4][5][15] - As of March 31, 2025, Vera had $589.8 million in cash, cash equivalents, and marketable securities, which is deemed sufficient to fund operations through the potential approval and U.S. commercial launch of atacicept [5][17] Business Highlights - The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of eGFR compared to placebo [7] - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential to significantly improve treatment outcomes compared to existing therapies [10] - Vera is expanding the atacicept development program to include additional autoimmune kidney diseases such as primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) [8][11] Financial Results - For Q1 2025, total operating expenses were $57.2 million, up from $31.1 million in Q1 2024, with research and development expenses increasing to $41.3 million from $23.2 million [15] - The net loss per share for Q1 2025 was $0.81, compared to $0.56 for the same period in 2024 [15] - The company’s total assets as of March 31, 2025, were $610.2 million, down from $655.7 million at the end of 2024, with total liabilities at $75.2 million [17][18]

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Enrollment and Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - Participants are randomized to receive either atacicept 150 mg or placebo via self-administered weekly subcutaneous injections for a 104-week double-blind period, followed by a 52-week open-label extension [2] Efficacy and Safety Data - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, with a key secondary endpoint assessing kidney function via estimated glomerular filtration rate (eGFR) over 104 weeks [3] - The Phase 2b ORIGIN trial demonstrated significant reductions in proteinuria and stabilization of eGFR, supporting the efficacy of atacicept [6] Future Plans and Market Position - The company plans to submit a BLA for atacicept in the second half of 2025, with a potential commercial launch in 2026 [2][8] - Vera Therapeutics retains all global developmental and commercial rights to atacicept and is also developing MAU868, a monoclonal antibody targeting BK virus [9]