Vera Therapeutics VERA

Vera Therapeutics reports Q3 2026 results

Item 2.02 Reports results

Form
8-K
Filed
Importance
Major
  1. $10.3 million net product revenue in Q3 2026
  2. ORIGIN 3 trial showed 76% reduction in kidney disease progression risk
  3. sBLA submitted for TRUTAKNA full FDA approval
  4. Net loss of $93.7 million in Q3 2026

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The reading, claim by claim

  1. Under Item 2.02, it says it issued a press release that day announcing financial results for the third quarter ended September 30, 2026, and providing recent corporate updates.
  2. The release is furnished as Exhibit 99.1.
  3. Item 2.02 states that the information, including Exhibit 99.1, shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934.
  4. Item 9.01 lists the press release dated November 5, 2026 as Exhibit 99.1, plus the cover page interactive data file as Exhibit 104.
  5. Sean Grant, Chief Financial Officer, signed the filing.
  6. The press release reports net product revenue of $10.3 million for the quarter ended September 30, 2026, with no product revenue in the prior year period.
  7. It reports a net loss of $93.7 million, or $1.30 per share, compared with a net loss of $80.3 million, or $1.26 per share, for the quarter ended September 30, 2025.
  8. The release says research and development expenses were $41.3 million, compared with $56.5 million in the prior-year quarter.
  9. It attributes the decrease primarily to lower contract manufacturing expenses, because TRUTAKNA commercial supply costs have been capitalized as inventory since its accelerated approval on July 7, 2026.
  10. It lists potential full approval, subject to FDA review, as expected in mid-2027.

10 of 10 claims matched the filing text.

For perspective, checked against its own source

From the 10-Q for the quarter ended September 30, 2026

  • In its 10-Q for the quarter ended September 30, 2026, Vera Therapeutics reported revenue of $10.3 million and net income of -$93.7 million.
  • The financial statements also show a gross margin of 67.9%.

From the filing

Item 2.02 Results of Operations and Financial Condition

Item 2.02 Results of Operations and Financial Condition

On November 5, 2026, Vera Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2026, and providing recent corporate updates.1 The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K2 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 19343, 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.14

Press Release of Vera Therapeutics, Inc., dated November 5, 2026 .4

1044

Cover Page Interactive Data File (embedded within the Inline XBRL document).4

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:

November 5, 2026

By:

/s/ Sean Grant5

Sean Grant, Chief Financial Officer5

Vera Therapeutics Provides Business Update and Reports Third Quarter 2026 Financial Results

• TRUTAKNA® (atacicept-vymj) U.S. launch building early momentum following July 7 accelerated approval by the U.S. Food and Drug Administration (FDA) with approximately 700 Patient Start Forms (PSFs) to date and $10.3 million of net product revenue in Q3.

• ORIGIN 3 final efficacy analysis demonstrated stabilization of kidney function and a 76% reduction in risk of composite kidney disease progression versus placebo through two years; data was presented as a late-breaking oral presentation at the opening plenary session at ASN Kidney Week 2026 with a simultaneous publication in The New England Journal of Medicine.

• Completed supplemental Biologics License Application (sBLA) submission to the FDA for full approval of TRUTAKNA in adults with primary IgAN.

• Management to host a live investor webcast at 4:30 p.m. ET on November 5, 2026.

BRISBANE, Calif., November 5, 2026 – Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today reported its business highlights and financial results for the quarter ended September 30, 2026.

"We are excited by the early momentum of the TRUTAKNA launch, which exemplifies our long-standing confidence in its potential to become a foundational therapy in IgAN. Our transition to a commercial-stage company marks a new chapter for Vera, as we deliver on our commitment to people living with IgAN," said Marshall Fordyce, M.D., Founder and Chief Executive Officer of Vera Therapeutics. "We recently presented the final efficacy results from the ORIGIN 3 trial at ASN Kidney Week 2026, strengthening the clinical foundation for TRUTAKNA. The stabilization of kidney function at the physiologic rate and significant reduction in risk of composite kidney disease progression through two years reinforce the potential for TRUTAKNA to change the course of IgAN and supported our recent submission of an sBLA for full FDA approval."

"Our team is executing on the launch priorities we established for TRUTAKNA, with growing interest from the IgAN community and approximately 700 PSFs received since launch," added Matt Skelton, Chief Commercial Officer of Vera Therapeutics. "We are encouraged by the payer coverage policies taking shape. Our focus remains on expanding access and ensuring nephrologists have the tools and education they need to help eligible patients begin treatment with TRUTAKNA."

Third Quarter 2026 and Recent Business Highlights

• Received FDA accelerated approval on July 7, 2026 for TRUTAKNA to reduce proteinuria in adults with primary IgAN at risk for disease progression. There are approximately 160,000 diagnosed IgAN patients in the U.S., roughly 75% of whom are commercially insured.

• Launched TRUTAKNA in the U.S., drawing on a cross-functional team experienced in rare disease and kidney therapies. Received approximately 700 PSFs to date following TRUTAKNA's accelerated approval.

• Presented detailed ORIGIN 3 final efficacy results as a late-breaking oral presentation at the opening plenary session of ASN Kidney Week 2026 with a simultaneous publication in The New England Journal of Medicine . 1 TRUTAKNA met all prespecified endpoints, including eGFR change from baseline and annualized slope, and risk reduction in composite kidney disease progression events. Through 104 weeks, the annualized eGFR slope was -0.6 mL/min/1.73m²/year with TRUTAKNA compared with -5.6 mL/min/1.73m²/year with placebo, a treatment difference of 5.0 mL/min/1.73m²/year (p<0.0001). The ORIGIN 3 safety profile was favorable, and generally comparable to placebo.

• Presented interim results from the adult IgAN and primary membranous nephropathy (pMN) cohorts of the Phase 2 PIONEER basket trial of atacicept as a late-breaking research oral presentation and outlined the trial's evaluation of pediatric patients with IgAN in an informational poster at ASN Kidney Week 2026. These interim results support the continued investigation of atacicept in antibody-mediated glomerular diseases.

• Completed supplemental Biologics License Application (sBLA) submission to the FDA on November 3, 2026 for full approval of TRUTAKNA in adults with primary IgAN, based on the ORIGIN 3 final efficacy analysis.

Anticipated Upcoming Milestones

• Potential full approval of TRUTAKNA in adults with primary IgAN, subject to FDA review of the sBLA, expected in mid-2027.10

• Planned Marketing Authorisation Application submission to the European Medicines Agency expected in Q1 2027 for standard marketing authorisation.

Financial Results for the Quarter Ended September 30, 2026

For the quarter ended September 30, 2026, Vera Therapeutics reported net product revenue of $10.3 million, compared with the prior year period during which no product revenue was reported.6 Vera Therapeutics reported a net loss of $93.7 million, or $1.30 per share, compared with a net loss of $80.3 million, or $1.26 per share, for the quarter ended September 30, 2025.7 Research and development expenses were $41.3 million, compared with $56.5 million in the prior-year quarter.8 The decrease was primarily due to a reduction in contract manufacturing expenses, as manufacturing costs for TRUTAKNA commercial supply, which were previously categorized as research and development expense, have been capitalized as inventory since its accelerated approval on July 7, 2026.9 Selling, g

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Data on this page was fetched . The filing on SEC.gov is the record.