[8-K] Vera Therapeutics, Inc. Reports Material Event
Rhea-AI Filing Summary
Vera Therapeutics reported first-quarter 2026 results and highlighted progress toward potential FDA accelerated approval of atacicept for IgA nephropathy, which is under Priority Review with a PDUFA date of July 7, 2026. The company posted a net loss of $121.0 million, or $1.69 per share, compared with a net loss of $51.7 million, or $0.81 per share, a year earlier as research and development and general and administrative spending rose sharply. Vera ended March 31, 2026 with $596.8 million in cash, cash equivalents and marketable securities and believes this, together with its debt facility, will fund operations through potential atacicept approval and U.S. commercial launch and beyond.
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Insights
Priority review advances atacicept, but losses widen as launch prep accelerates.
Vera Therapeutics secured FDA Priority Review for its atacicept BLA in IgA nephropathy, with a PDUFA date of July 7, 2026. This moves its lead asset closer to potential accelerated approval while the company readies for a planned U.S. launch in mid-2026, pending approval.
Operating expenses more than doubled to $125.1 million in Q1 2026, driving a net loss of $121.0 million versus $51.7 million a year earlier as Vera invested heavily in R&D and commercial infrastructure. Cash, cash equivalents and marketable securities were $596.8 million, and the company believes this, plus its debt facility, can support operations through potential approval and launch.
Upcoming milestones include the PDUFA decision on atacicept in IgA nephropathy, initial results from the PIONEER Phase 2 basket trial expected in Q2 2026, and pivotal two-year eGFR data from ORIGIN 3 anticipated in Q1 2027. These events will further clarify atacicept’s clinical and commercial profile.
8-K Event Classification
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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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:
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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 May 7, 2026, Vera Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for first quarter ended March 31, 2026, 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. |
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Description |
99.1 |
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Press Release of Vera Therapeutics, Inc., dated May 7, 2026. |
104 |
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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.
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Vera Therapeutics, Inc. |
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Date: |
May 7, 2026 |
By: |
/s/ Sean Grant |
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Sean Grant, Chief Financial Officer |
Exhibit 99.1
Vera Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results
BRISBANE, Calif., May 7, 2026 – Vera Therapeutics, Inc. (Nasdaq: VERA), a 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, 2026.
“The team at Vera Therapeutics is focused on execution as we advance atacicept toward potential FDA accelerated approval in IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “During the first quarter, we made meaningful progress across key pre‑commercial activities, including in sales, marketing, market access, compliance, and commercial operations, to support a successful U.S. launch, pending regulatory approval. We are excited for atacicept to potentially be the first approved drug targeting both BAFF and APRIL in IgAN patients.”
First Quarter 2026 and Recent Business Highlights
Anticipated Upcoming Milestones
Financial Results for the Quarter Ended March 31, 2026
For the quarter ended March 31, 2026, Vera Therapeutics reported a net loss of $121.0 million, or a net loss per diluted share of $1.69, compared to a net loss of $51.7 million, or a net loss per diluted share of $0.81, for the quarter ended March 31, 2025.
During the quarter ended March 31, 2026, net cash used in operating activities was $106.5 million, compared to $54.4 million for the quarter ended March 31, 2025.
Vera Therapeutics reported $596.8 million in cash, cash equivalents, and marketable securities as of March 31, 2026, 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.
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 Q1 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.
The atacicept monthly dose range finding study was initiated in 2025 to explore the effectiveness, safety, and tolerability of different dosing regimens of atacicept. Enrollment in the study has been completed.
About Vera Therapeutics
Vera Therapeutics is a 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.; Vera Therapeutics' ability to fund operations beyond anticipated approval and U.S. commercial launch of atacicept; the potential for atacicept to be the first approved drug targeting both BAFF and APRIL in IgAN patients; timing of initial results from PIONEER; timing of 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
VERA THERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended |
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March 31, |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
$ |
86,011 |
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$ |
41,278 |
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General and administrative |
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39,121 |
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15,916 |
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Total operating expenses |
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125,132 |
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57,194 |
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Loss from operations |
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(125,132 |
) |
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(57,194 |
) |
Other income, net |
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4,100 |
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5,500 |
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Net loss |
$ |
(121,032 |
) |
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$ |
(51,694 |
) |
Change in unrealized gain/loss on marketable securities |
$ |
(942 |
) |
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$ |
261 |
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Comprehensive loss |
$ |
(121,974 |
) |
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$ |
(51,433 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(1.69 |
) |
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$ |
(0.81 |
) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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71,476,595 |
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63,671,558 |
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VERA THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands)
(Unaudited)
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March 31, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash, cash equivalents and marketable securities |
$ |
596,760 |
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$ |
714,589 |
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Prepaid expenses and other assets, current |
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19,042 |
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14,294 |
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Total current assets |
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615,802 |
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728,883 |
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Other assets, noncurrent |
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5,937 |
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5,850 |
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Total assets |
$ |
621,739 |
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$ |
734,733 |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
$ |
13,909 |
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$ |
21,898 |
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Accrued expenses and other liabilities, current |
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31,240 |
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31,557 |
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Total current liabilities |
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45,149 |
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53,455 |
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Long-term debt |
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75,029 |
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74,838 |
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Other liabilities, noncurrent |
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1,864 |
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1,919 |
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Total liabilities |
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122,042 |
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130,212 |
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Stockholders' equity |
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Common stock |
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72 |
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71 |
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Additional paid-in-capital |
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1,381,678 |
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1,364,529 |
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Accumulated other comprehensive (loss) income |
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(156 |
) |
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786 |
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Accumulated deficit |
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(881,897 |
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(760,865 |
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Total stockholders' equity |
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499,697 |
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604,521 |
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Total liabilities and stockholders' equity |
$ |
621,739 |
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$ |
734,733 |
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