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

Rhea-AI Summary

Vera Therapeutics (NASDAQ: VERA) reported full-year 2025 results and a business update. Positive ORIGIN Phase 3 atacicept data were presented at ASN and published in NEJM, and the FDA granted priority review with a PDUFA date of July 7, 2026.

The company plans a potential mid-2026 U.S. commercial launch if approved. Vera completed equity and debt financings with combined potential gross proceeds of $800 million, and held $714.6 million in cash, equivalents and marketable securities at 12/31/2025. Net loss was $299.6 million for 2025.

Positive

• Positive ORIGIN Phase 3 primary endpoint results presented and published
• FDA priority review granted; PDUFA date set for July 7, 2026
• $714.6M cash plus financings with potential gross proceeds of $800M

Negative

• Net loss widened to $299.6M in 2025 from $152.1M in 2024
• Net cash used in operations increased to $241.1M in 2025

Key Figures

Net loss 2025: $299.6 million EPS 2025: Net loss per diluted share of $4.66 Net loss 2024: $152.1 million +5 more

8 metrics

Net loss 2025 $299.6 million Full year ended December 31, 2025

EPS 2025 Net loss per diluted share of $4.66 Full year 2025

Net loss 2024 $152.1 million Full year ended December 31, 2024

EPS 2024 Net loss per diluted share of $2.75 Full year 2024

Operating cash use 2025 $241.1 million Net cash used in operating activities, 2025

Operating cash use 2024 $134.7 million Net cash used in operating activities, 2024

Cash & securities $714.6 million Cash, cash equivalents, and marketable securities as of Dec 31, 2025

Financing capacity 2025 $800 million Combined potential gross proceeds from 2025 equity and debt transactions

Market Reality Check

Price: $41.68 Vol: Volume 775,126 is below 2...

normal vol

$41.68 Last Close

Volume Volume 775,126 is below 20-day average of 937,314 (relative volume 0.83). normal

Technical Shares at 41.68 are trading above the 200-day MA of 31.05, reflecting a longer-term uptrend into this update.

Peers on Argus

VERA is down 1.63% while peers show mixed moves: AUPH -1.5%, VRDN -2.13%, ARDX +...

2 Up 1 Down

VERA is down 1.63% while peers show mixed moves: AUPH -1.5%, VRDN -2.13%, ARDX +1.08%, CDTX +0.03%, EWTX -2.82%, indicating stock-specific trading rather than a clean sector trend.

Common Catalyst Multiple kidney/biotech peers (VRDN, AUPH) also reported earnings and business updates today, pointing to an earnings-driven news cluster.

Previous Earnings Reports

5 past events · Latest: Nov 05 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 05	Q3 2025 earnings	Positive	-1.0%	Q3 2025 results plus preview of ORIGIN 3 data ahead of ASN.
Aug 05	Q2 2025 earnings	Positive	+0.9%	Positive pivotal ORIGIN 3 data, BLA plan, and $500M credit facility.
May 06	Q1 2025 earnings	Positive	-13.8%	Q1 results and timeline toward Phase 3 ORIGIN readout and BLA.
Feb 26	FY 2024 earnings	Positive	+2.5%	FY 2024 update with Breakthrough Therapy and strong cash from equity deals.
Nov 07	Q3 2024 earnings	Positive	+2.3%	Q3 2024 results, positive ORIGIN Phase 2b data, and large equity raise.

Pattern Detected

Earnings updates often highlight positive atacicept progress and strong cash but have averaged a modest -1.83% move, with mixed alignment between news tone and price.

Recent Company History

Over the past year, earnings updates have traced atacicept’s path from Phase 2b ORIGIN data and Q3 2024 enrollment completion to 2025’s pivotal ORIGIN 3 results and BLA plans. Prior releases emphasized Breakthrough Therapy Designation, positive proteinuria and eGFR data, and progressively larger cash balances from financings and a credit facility. Those reports showed a mix of positive and negative single‑day moves, suggesting investors weigh dilution, losses, and development risk against clinical and regulatory momentum, which frames today’s full‑year 2025 loss and priority review news.

Historical Comparison

-1.8% avg move · Recent earnings releases averaged a -1.83% move across 5 events. Today’s full‑year 2025 update with ...

earnings

-1.8%

Average Historical Move earnings

Recent earnings releases averaged a -1.83% move across 5 events. Today’s full‑year 2025 update with priority review and strong cash follows a similar pattern of clinically positive but market-cautious reactions.

Earnings updates have charted atacicept’s evolution from Phase 2b stabilization data and ORIGIN 3 enrollment to pivotal ORIGIN 3 results, BLA submission plans, and now FDA priority review with a targeted mid‑2026 commercial launch.

Market Pulse Summary

This announcement combines positive clinical and regulatory milestones with a substantially larger f...

Analysis

This announcement combines positive clinical and regulatory milestones with a substantially larger full‑year net loss of $299.6M. Investors may focus on FDA priority review, the July 7, 2026 PDUFA date, and strong liquidity of $714.6M in cash and securities plus $800M in potential financing capacity. Historical earnings releases show mixed single‑day reactions, so continued attention to spending levels, pivotal ORIGIN 3 follow‑up, and timelines for PIONEER results will be important.

Key Terms

phase 3, biologics license application (bla), pdufa, priority review, +3 more

7 terms

phase 3 medical

"Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

biologics license application (bla) regulatory

"FDA granted priority review to Biologics License Application (BLA) for atacicept"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

pdufa regulatory

"with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

priority review regulatory

"FDA granted priority review to Biologics License Application (BLA) for atacicept"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

basket trial medical

"PIONEER – a Phase 2 basket trial evaluating atacicept in expanded IgAN populations"

A basket trial is a type of clinical study that tests one treatment across multiple diseases or patient groups that share a common biological feature, like a genetic marker. Think of it as trying one key in several different locks that use the same mechanism; positive results can speed development and expand a drug’s potential market, while mixed results can raise uncertainty about which patient groups will benefit and how regulators will view approvals.

proteinuria medical

"results in clinically meaningful reductions to proteinuria, Gd-IgA1, and hematuria"

Proteinuria is when abnormal amounts of protein are found in a person's urine. It can be a sign that the kidneys aren't working properly, since healthy kidneys usually prevent most proteins from passing into urine. Detecting proteinuria helps doctors identify and monitor kidney problems early.

marketable securities financial

"reported $714.6 million in cash, cash equivalents, and marketable securities"

Marketable securities are financial assets — such as publicly traded stocks, bonds, and short-term government bills — that a company can quickly sell for cash at a known price. Investors watch them because they show how much ready cash a company can access without selling core operations, like keeping money in a highly liquid savings account versus being tied up in a house, and they affect short-term risk, financial flexibility, and balance-sheet strength.

AI-generated analysis. Not financial advice.

• 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., Feb. 26, 2026 (GLOBE NEWSWIRE) -- 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 of 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; Vera Therapeutics plans for a potential commercial launch in mid-2026
• Matt Skelton, Chief Commercial Officer, advancing preparations for U.S. commercial launch
• 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.

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 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

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

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 is the FDA timeline for atacicept (VERA) approval in IgA nephropathy?

The FDA set a PDUFA target action date of July 7, 2026. According to the company, the BLA for atacicept received priority review, positioning a regulatory decision by that date.

When would Vera Therapeutics (VERA) launch atacicept commercially if approved?

Vera plans a potential U.S. commercial launch in mid-2026, pending approval. According to the company, commercial preparations are underway to support a launch timeline around mid-2026.

How strong is Vera Therapeutics' balance sheet heading into 2026 (VERA)?

Vera reported $714.6 million in cash, equivalents and marketable securities as of 12/31/2025. According to the company, combined with available debt capacity and financings, this is expected to fund operations through potential approval and launch.

What were Vera Therapeutics' (VERA) 2025 financial results and cash burn?

Vera posted a $299.6 million net loss for 2025 and used $241.1 million in operating cash. According to the company, both figures increased versus 2024, reflecting late-stage development and commercial preparation costs.

What clinical evidence supports atacicept for IgA nephropathy (VERA)?

ORIGIN Phase 3 achieved a positive primary endpoint and was presented at ASN and published in NEJM. According to the company, atacicept reduced proteinuria and other disease markers in Phase 2 and Phase 3 data.