VERA

EX-99.1

2 vera-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

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

• TRUTAKNA™ granted accelerated approval by U.S. Food and Drug Administration (FDA) in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression.

• Alignment with FDA on earlier ORIGIN 3 final efficacy analysis to support potential full approval for TRUTAKNA in adults with IgAN; results expected in Q3 2026.

• Anticipated supplemental Biologics License Application (sBLA) submission to the FDA – expected in Q4 2026.

BRISBANE, Calif., August 10, 2026 – Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today reported its business highlights and financial results for the quarter ended June 30, 2026.

“The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result of of years of hard work and dedication. We are extremely grateful to the patients, investigators, employees, and collaborators who have contributed to this moment,” said Marshall Fordyce, M.D., Founder and Chief Executive Officer of Vera Therapeutics. “We are thrilled that TRUTAKNA is available to eligible patients as the first and only therapy to inhibit both BAFF and APRIL in IgAN patients. We are focused on a successful U.S. launch of TRUTAKNA, and we continue to advance the ORIGIN 3 program in support of a potential full approval.”

“Our team has decades of experience commercializing innovative therapies, successfully launching multiple blockbusters and kidney therapies,” added Matt Skelton, Chief Commercial Officer of Vera Therapeutics. "Since receiving approval, our team has been promoting TRUTAKNA, and the early reception has been encouraging. We are laying the groundwork for long-term leadership in helping IgAN patients. We believe that the efficacy and safety profile of TRUTAKNA and the quality of our people will allow us to effectively serve nephrologists and IgAN patients in their treatment decisions.”

TRUTAKNA Launch Update

• TRUTAKNA positioned to address significant patient need as the first and only BAFF and APRIL inhibitor approved for IgAN. IgAN is a serious, progressive kidney disease driven by B-cell–mediated immune complex formation. TRUTAKNA is the first FDA-approved therapy to target both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), the key upstream drivers of IgAN pathophysiology. There are approximately 160,000 diagnosed IgAN patients in the U.S., roughly ~75% of whom are commercially insured.

• Strong clinical profile positions TRUTAKNA as a potential foundational therapy in IgAN. The accelerated approval of TRUTAKNA was based on results from the ORIGIN Phase 3 trial, published in the New England Journal of Medicine in November 2025. At 36 weeks, TRUTAKNA demonstrated a 46% reduction from baseline and 42% reduction versus placebo in proteinuria, with consistent benefit across all prespecified subgroups.

TRUTAKNA-treated patients also showed a 68% reduction in galactose-deficient IgA1 (Gd-IgA1) and resolution of hematuria in 81% of patients with hematuria at baseline. TRUTAKNA was generally well tolerated, with no serious, severe, or opportunistic infections and no cases of hypogammaglobulinemia observed. In addition, there were no clinically significant effects of anti-drug antibodies on the pharmacokinetics, pharmacodynamics, safety, or efficacy of TRUTAKNA over the treatment period. TRUTAKNA is a once-weekly, at-home autoinjector, a desirable presentation for patients with proven success in other diseases.

• Experienced team executing on U.S. specialty launch. Vera Therapeutics has assembled an experienced cross-functional organization across sales, marketing, market access, patient support, and medical affairs with decades of experience in rare disease and kidney therapies. Eligible commercially insured patients may pay as little as $0 out of pocket through the TRUTAKNA TRU SUPPORT™ program.

Second Quarter 2026 and Recent Business Highlights

• Received FDA accelerated approval for TRUTAKNA to reduce proteinuria in adult patients with primary IgAN at risk for disease progression

• U.S. commercial launch of TRUTAKNA, the first and only available therapy that binds both BAFF and APRIL, is underway

• Aligned with the FDA on an earlier ORIGIN 3 final efficacy analysis to support potential full approval of TRUTAKNA in adults with IgAN

• Announced the appointment of Nancy Boman, M.D., Ph.D. as Chief Regulatory Officer of Vera Therapeutics, succeeding William Turner, effective upon his retirement and transition to the role of Strategic Advisor in the third quarter of 2026

• TRUTAKNA extended dose range finding study enrollment complete

Anticipated Upcoming Milestones

• Final efficacy analysis from the ORIGIN 3 trial expected in Q3 2026

• Anticipated sBLA submission to the FDA expected in Q4 2026

• Additiona

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

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

• U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for the accelerated approval of atacicept in adult patients with IgA Nephropathy (IgAN) with a Prescription Drug User Fee Act (PDUFA) date of July 7, 2026

• On track for U.S. commercial launch of atacicept in mid-2026, pending regulatory approval

• Strong balance sheet expected to be sufficient to fund operations beyond potential atacicept approval and U.S. commercial launch

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

• 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

• Vera Therapeutics continues to advance preparations ahead of potential commercial launch in mid-2026

• Company bolsters its executive team and Board of Directors with the promotion of Matt Skelton to Chief Commercial Officer and the appointments of accomplished biopharma leaders, Jane Wright-Mitchell as Chief Legal Officer, and Christopher Hite as a member of the Board of Directors

• Strong balance sheet expected to be sufficient to fund operations beyond the potential approval and U.S. commercial launch of atacicept

Anticipated Upcoming Milestones

• Potential FDA accelerated approval of atacicept in IgAN with a PDUFA date of July 7, 2026

• Planned U.S. commercial launch of atacicept expected mid-2026, pending FDA approval

• Initial results from PIONEER, a Phase 2 basket trial evaluating atacicept in expanded IgAN populations and other autoimmune kidney diseases, expected in Q2 2026

• Pivotal two-year eGFR data from the ORIGIN 3 trial expected Q1 2027

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 measur

8-K

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