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Vera Therapeutics (VERA) widens 2025 loss as atacicept wins FDA priority review

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Vera Therapeutics reported a larger full-year 2025 net loss of $299.6 million, or $4.66 per share, compared with a $152.1 million loss a year earlier, as research and development and general and administrative expenses rose to a combined $315.5 million. Net cash used in operating activities was $241.1 million.

The company ended 2025 with $714.6 million in cash, cash equivalents, and marketable securities and completed equity and debt financings with combined potential gross proceeds of $800 million, which it believes can fund operations beyond potential approval and U.S. commercial launch of atacicept. Vera highlighted positive Phase 3 ORIGIN data for atacicept in IgA nephropathy and noted the FDA has granted priority review to its Biologics License Application, with a PDUFA action date of July 7, 2026 and a planned U.S. launch in mid-2026, if approved.

Positive

  • Regulatory momentum for lead asset: FDA granted priority review to the Biologics License Application for atacicept in IgA nephropathy, with a PDUFA target action date of July 7, 2026, following positive Phase 3 ORIGIN data and publication in the New England Journal of Medicine.
  • Strengthened balance sheet and funding runway: Year-end 2025 cash, cash equivalents, and marketable securities of $714.6 million, plus combined potential gross proceeds of $800 million from equity and debt financings, are expected by the company to fund operations through potential approval and U.S. launch of atacicept and beyond.

Negative

  • None.

Insights

Lead drug advances with priority review as losses widen but cash remains strong.

Vera Therapeutics is still pre-revenue and posted a larger 2025 net loss of $299.6 million, driven by research and development and commercial readiness spending for atacicept. Operating cash outflow reached $241.1 million, reflecting an intensive late-stage development phase.

Strategically, the key development is regulatory: the FDA granted priority review to the atacicept BLA in IgA nephropathy, with a PDUFA date of July 7, 2026. Positive Phase 3 ORIGIN results and favorable safety data support management’s confidence in the package, though approval is not assured.

On funding, year-end cash, cash equivalents, and marketable securities of $714.6 million, combined with an equity financing and debt agreement totaling potential gross proceeds of $800 million, are expected by the company to support operations through potential approval and a planned mid-2026 U.S. commercial launch of atacicept and beyond.

0001831828false00018318282026-02-262026-02-26

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 26, 2026

 

 

Vera Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-40407

81-2744449

(State or other jurisdiction
of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

2000 Sierra Point Parkway, Suite 1200

 

Brisbane, California

 

94005

(Address of principal executive offices)

 

(Zip Code)

 

(650) 770-0077

Registrant’s telephone number, including area code
 

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Class A common stock, $0.001 par value per share

 

VERA

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 


 

Item 2.02 Results of Operations and Financial Condition

 

On February 26, 2026, Vera Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the full year ended December 31, 2025, and providing recent corporate updates. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information contained in this Current Report on Form 8-K (including Exhibit 99.1 hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

Description

99.1

Press Release of Vera Therapeutics, Inc., dated February 26, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Vera Therapeutics, Inc.

 

 

 

 

Date:

February 26, 2026

By:

/s/ Sean Grant

 

 

 

Sean Grant, Chief Financial Officer

 


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Exhibit 99.1

 

Vera Therapeutics Provides Business Update and Reports Full Year 2025 Financial Results

Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy (IgAN) presented at American Society of Nephrology (ASN) Kidney Week and published in the New England Journal of Medicine
U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for atacicept with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026; potential commercial launch of atacicept expected in mid-2026
Strong balance sheet bolstered by equity and debt financings in 2025 expected to be sufficient to fund company beyond atacicept approval and U.S. commercial launch

BRISBANE, Calif., February 26, 2026 – 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 full year ended December 31, 2025.

“In 2025, Vera Therapeutics delivered on several key milestones as we advanced atacicept toward potential FDA approval and commercialization,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The BLA has been granted priority review and we expect to be commercially prepared to successfully launch atacicept in IgAN in mid-2026 if approved. Our commercial team brings decades of experience launching innovative therapies and is eager to bring this potentially disease-modifying therapy to patients with IgAN and other autoimmune kidney diseases.”

 

“Vera Therapeutics has established a leadership position within the IgAN space based on the compelling profile of atacicept. Data from the ORIGIN clinical program have shown that blocking BAFF and APRIL with atacicept results in clinically meaningful reductions to proteinuria, Gd-IgA1, and hematuria (phase 2 and 3) and a stabilization of eGFR (phase 2)” said Robert M. Brenner, M.D., Chief Medical Officer, Vera Therapeutics. “Vera is confident in the strength of the atacicept data package to support approval and deliver a potential new therapy to the IgAN patients and caregivers whom we serve.”

Key Full Year 2025 and Recent Business Highlights

Positive primary endpoint results from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of (IgAN) were presented in a featured late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2025 and published in the New England Journal of Medicine
FDA granted priority review to the atacicept BLA for the treatment of IgAN in adults, and assigned a PDUFA target action date of July 7, 2026; Company plans for a potential commercial launch in mid-2026
Matt Skelton, Chief Commercial Officer, advancing preparations for U.S. commercial launch

 

 


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Appointed James R. Meyers, an accomplished biopharmaceutical executive with over three decades of commercial leadership experience, to Board of Directors
Successfully completed an equity financing and entered into a debt agreement resulting in combined potential gross proceeds of $800 million, strengthening Vera Therapeutics' balance sheet to fund operations beyond the potential approval and U.S. commercial launch of atacicept

 

Anticipated Upcoming Milestones

Potential FDA approval of atacicept in IgAN – PDUFA date of July 7, 2026
Planned U.S. commercial launch of atacicept, pending FDA approval – mid-2026
Initial results from PIONEER – a Phase 2 basket trial evaluating atacicept in expanded IgAN populations, and other autoimmune kidney diseases – expected in 1H 2026
Pivotal ORIGIN 3 study completion with two-year eGFR data – expected in 2027

Financial Results for the Year Ended December 31, 2025

For the year ended December 31, 2025, Vera Therapeutics reported a net loss of $299.6 million, or a net loss per diluted share of $4.66, compared to a net loss of $152.1 million, or a net loss per diluted share of $2.75, for the year ended December 31, 2024.

 

During the year ended December 31, 2025, net cash used in operating activities was $241.1 million, compared to $134.7 million for the year ended December 31, 2024.

 

Vera Therapeutics reported $714.6 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which combined with availability under its debt facility, Vera Therapeutics believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond.

 

About 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 IgAN, lupus nephritis, and other autoimmune kidney diseases.

About the Atacicept Clinical Program

The ORIGIN Phase 2b 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 improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN.

 

 


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The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR, with results expected in 2027. For more information about ORIGIN 3, please visit http://www.clinicaltrials.gov.

 

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 ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics 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 trials across different disease areas.

 

The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial.

About Vera Therapeutics

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics 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. Vera Therapeutics is also evaluating development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. 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, approval of atacicept by the FDA, including expected timing; the timing, preparedness and success of the commercial launch of atacicept in the U.S.; the ability of

 

 


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atacicept to be a disease-modifying therapy for patients with IgAN and other autoimmune kidney diseases; Vera Therapeutics' confidence in the strength of the atacicept data package to support FDA approval; Vera Therapeutics' ability to fund operations beyond anticipated approval and U.S. commercial launch of atacicept; timing of initial results from PIONEER and completion of ORIGIN 3; atacicept’s positioning for best-in-class potential; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as "anticipate," “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics’ 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 Therapeutics’ business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics' filings with the U.S. 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 Therapeutics 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 Allaire

LifeSci Advisors

212-915-2569

jallaire@lifesciadvisors.com

Media Contact:

Debra Charlesworth

Vera Therapeutics
415-854-8051

corporatecommunications@veratx.com

 

 

 

 

 


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VERA THERAPEUTICS, INC.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

For the Year Ended December 31,

 

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

215,256

 

 

$

126,172

 

General and administrative

 

 

100,217

 

 

 

40,998

 

Total operating expenses

 

 

315,473

 

 

 

167,170

 

Loss from operations

 

 

(315,473

)

 

 

(167,170

)

Other income, net

 

 

15,859

 

 

 

15,023

 

Provision for income taxes

 

 

(1

)

 

 

(1

)

Net loss

 

$

(299,615

)

 

$

(152,148

)

Change in fair value on marketable securities

 

 

393

 

 

 

142

 

Comprehensive loss

 

$

(299,222

)

 

$

(152,006

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(4.66

)

 

$

(2.75

)

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

64,233,814

 

 

 

55,326,680

 

 

 

 


img47757703_0.jpg

 

VERA THERAPEUTICS, INC.

Condensed Balance Sheets

(in thousands)

(Unaudited)

 

December 31,

 

 

2025

 

 

2024

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash, cash equivalents and marketable securities

$

714,589

 

 

$

640,852

 

Prepaid expenses and other current assets

 

14,294

 

 

 

10,366

 

Total current assets

 

728,883

 

 

 

651,218

 

Operating lease right-of-use assets

 

1,923

 

 

 

3,372

 

Other noncurrent assets

 

3,927

 

 

 

1,091

 

Total assets

$

734,733

 

 

$

655,681

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

21,898

 

 

$

7,665

 

Operating lease liabilities

 

549

 

 

 

1,483

 

Accrued expenses and other liabilities, current

 

31,008

 

 

 

16,223

 

Total current liabilities

 

53,455

 

 

 

25,371

 

Long-term debt

 

74,838

 

 

 

50,687

 

Operating lease liabilities, noncurrent

 

1,919

 

 

 

2,468

 

Total liabilities

 

130,212

 

 

 

78,526

 

Stockholders' equity

 

 

 

 

 

Common stock

 

71

 

 

 

64

 

Additional paid-in-capital

 

1,364,529

 

 

 

1,037,948

 

Accumulated other comprehensive income

 

786

 

 

 

393

 

Accumulated deficit

 

(760,865

)

 

 

(461,250

)

Total stockholders' equity

 

604,521

 

 

 

577,155

 

Total liabilities and stockholders' equity

$

734,733

 

 

$

655,681

 

# # #

 

 

 


FAQ

What were Vera Therapeutics (VERA) 2025 financial results?

Vera Therapeutics reported a 2025 net loss of $299.6 million, or $4.66 per share, compared with a $152.1 million loss in 2024. Operating expenses rose to $315.5 million, and net cash used in operating activities was $241.1 million for the year.

How much cash does Vera Therapeutics (VERA) have to fund atacicept?

Vera ended 2025 with $714.6 million in cash, cash equivalents, and marketable securities. Together with an equity financing and debt agreement totaling potential gross proceeds of $800 million, the company believes this will fund operations through potential atacicept approval and U.S. commercial launch and beyond.

What is the FDA status of atacicept for IgA nephropathy at Vera Therapeutics (VERA)?

The FDA has granted priority review to Vera’s Biologics License Application for atacicept in IgA nephropathy and set a PDUFA action date of July 7, 2026. The company is planning for a potential U.S. commercial launch in mid-2026, if atacicept is approved.

What clinical data support atacicept at Vera Therapeutics (VERA)?

Atacicept showed positive primary endpoint results in the ORIGIN Phase 3 trial, with statistically significant and clinically meaningful proteinuria reductions at week 36. Phase 2b data also showed proteinuria reductions and eGFR stabilization, and results have been presented at ASN Kidney Week and published in the New England Journal of Medicine.

What upcoming milestones has Vera Therapeutics (VERA) outlined for atacicept?

Key milestones include potential FDA approval of atacicept in IgA nephropathy by the July 7, 2026 PDUFA date, a planned U.S. launch in mid-2026, initial PIONEER Phase 2 basket trial results in the first half of 2026, and completion of ORIGIN 3 two-year eGFR data in 2027.

How did Vera Therapeutics (VERA) operating expenses change in 2025?

Operating expenses increased to $315.5 million in 2025 from $167.2 million in 2024. Research and development expenses were $215.3 million, and general and administrative expenses were $100.2 million, reflecting late-stage clinical development and commercialization preparation.

What is Vera Therapeutics’ (VERA) core business focus and lead program?

Vera Therapeutics is a late clinical-stage biotechnology company focused on serious immunological diseases. Its lead product candidate is atacicept, a once-weekly subcutaneous fusion protein that blocks BAFF and APRIL to reduce autoantibodies, being developed primarily for IgA nephropathy and other autoimmune kidney diseases.

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