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Vera Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results • On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (I

Key Takeaway: Vera Therapeutics has provided a business update and reported financial results for Q1 2025, highlighting its progress towards the pivotal Phase 3 ORIGIN trial results for atacicept in IgA Nephropathy, expected in 2Q 2025. The company is also planning to submit a Biologics License Application for this treatment by the end of 2025. Despite reporting a significant net loss for the quarter, Vera is expanding its atacicept program into various autoimmune kidney diseases, indicating a focus on growth and innovation in immunological therapy development.
Price reaction · baseline $25.53 (2025-05-05 close) · hit after-hours · 1 other VERA headline(s) in the window, move may be shared
day 0 close
-13.8%
day 1
-11.4%
day 3 · peak
-15%

Market Sentiment Analysis

POSITIVE FACTORS

  • Vera Therapeutics is on track to announce primary endpoint results from the pivotal atacicept ORIGIN trial in 2Q 2025.
  • The company plans to submit a Biologics License Application for atacicept by 4Q 2025, signaling potential regulatory approval.
  • Expansion of atacicept development across various autoimmune diseases showcases strategic growth potential.

CONCERNS & RISKS

  • The company reported a net loss of $51.7 million for Q1 2025, indicating financial pressure.
  • Higher cash burn, with net cash used in operating activities increased to $54.4 million, raises concerns about financial sustainability.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+38%
120-day peak, hindsight
Typical move
3.5%
average across 4 past catalysts
Cash runway
~15 mo
Low dilution risk
Lead asset
Atacicept
Phase 3 · IgA Nephropathy

Full Press Release Details

Vera Therapeutics Provides Business Update and Reports
First Quarter 2025 Financial Results
-On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics License Application (BLA) submission for atacicept accelerated approval to the U.S. FDA in 4Q 2025
-Expanded atacicept development program across multiple autoimmune kidney diseases is underway
BRISBANE, Calif., May 6, 2025 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, 2025.
We are rapidly approaching a significant Vera milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, and if successful, we expect this to enable a BLA submission to the FDA in the second half of this year, which may allow approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.
First Quarter 2025 and Recent Business Highlights
-Completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgAN
-Enrolling participants in the ORIGIN EXTEND study, which provides participants in the ORIGIN Phase 2b or Phase 3 trials with extended access to atacicept, and captures longer-term safety and efficacy data
-Acquired exclusive development and commercialization rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across the spectrum of B cell mediated diseases
-Introduced an expanded development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD)
Major Upcoming Milestones
-Anticipated announcement of the primary endpoint results from the pivotal ORIGIN 3 trial in 2Q 2025
-Plan to submit a Biologics License Application (BLA) for atacicept in IgAN to the U.S. FDA in 4Q 2025 for accelerated approval; potential PDUFA date and commercial launch in 2026
Financial Results for the Quarter Ended March 31, 2025
For the quarter ended March 31, 2025, the company reported a net loss of $51.7 million, or a net loss per share of $0.81, compared to a net loss of $28.4 million, or a net loss per diluted share of $0.56, for the quarter ended March 31, 2024.
During the quarter ended March 31, 2025, net cash used in operating activities was $54.4 million, compared to $33.8 million for the same period last year.
Vera reported $589.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept.
Atacicept 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.
Vera 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. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please visit www.veratx.com.
Forward-looking Statements
Statements 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 plans to receive and report primary endpoint results in the Phase 3 ORIGIN 3 trial, to submit a BLA to the FDA, and to potentially receive a PDUFA date, receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and Vera's ability to fund its operations through potential approval and U.S. commercial launch of atacicept. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as anticipate, believe, on track, plan, 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:
LifeSci Communications
VERA THERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Three Months Ended
March 31,
2025 2024
(unaudited)
Operating expenses:
Research and development $ 41,278 $ 23,200
General and administrative 15,916 7,912
Total operating expenses 57,194 31,112
Loss from operations (57,194 ) (31,112 )
Other income, net 5,500 2,729
Net loss $ (51,694 ) $ (28,383 )
Change in unrealized gain/loss on marketable securities $ 261 $ (424 )
Comprehensive loss $ (51,433 ) $ (28,807 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.81 ) $ (0.56 )
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 63,671,558 50,971,933
VERA THERAPEUTICS, INC.
Condensed Balance Sheets
March 31, December 31,
2025 2024
(unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable securities $ 589,834 $ 640,852
Prepaid expenses and other current assets 16,242 10,366
Total current assets 606,076 651,218
Operating lease right-of-use assets 2,915 3,372
Other noncurrent assets 1,176 1,091
Total assets $ 610,167 $ 655,681
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 9,262 $ 7,665
Operating lease liabilities 1,191 1,483
Accrued expenses and other liabilities, current 11,441 16,223
Total current liabilities 21,894 25,371
Long-term debt 50,908 50,687
Operating lease liabilities, noncurrent 2,366 2,468
Total liabilities 75,168 78,526
Stockholders' equity
Common stock 64 64
Additional paid-in-capital 1,047,225 1,037,948
Accumulated other comprehensive income 654 393
Accumulated deficit (512,944 ) (461,250 )
Total stockholders' equity 534,999 577,155
Total liabilities and stockholders' equity $ 610,167 $ 655,681

Frequently Asked Questions

What is the primary endpoint result announcement date for atacicept?

The primary endpoint results from the ORIGIN trial are expected in 2Q 2025.

When does Vera plan to submit a BLA for atacicept?

The company plans to submit a BLA for atacicept in 4Q 2025.

What recent study has Vera initiated for atacicept?

Vera is enrolling participants in the ORIGIN EXTEND study for atacicept.

What is the financial loss Vera reported for Q1 2025?

Vera reported a net loss of $51.7 million for the quarter ending March 31, 2025.

What designation has atacicept received from the FDA?

Atacicept has received FDA Breakthrough Therapy Designation for IgAN.

Last updated: May 6, 2025