Vera Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results

Rhea-AI Summary

Vera Therapeutics (Nasdaq: VERA) reported significant progress in Q2 2025, highlighted by positive results from their pivotal ORIGIN 3 trial for atacicept in IgA Nephropathy (IgAN) treatment. The trial achieved its primary endpoint with a 42% reduction in UPCR compared to placebo (p<0.0001), and participants showed a 46% reduction in proteinuria from baseline.

The company plans to submit a Biologics License Application (BLA) for atacicept to the FDA in Q4 2025, targeting commercial launch in 2026. Vera also initiated the PIONEER trial to evaluate atacicept in expanded patient populations. Financially, Vera secured a $500 million credit facility with Oxford Finance LLC and reported $556.8 million in cash and equivalents, ensuring funding through potential commercial launch.

Positive

• Achieved primary endpoint with 42% reduction in UPCR vs placebo (p<0.0001)
• Secured $500 million credit facility extending cash runway beyond commercial launch
• Strong cash position of $556.8 million as of June 30, 2025
• Completed full enrollment in ORIGIN 3 trial with favorable safety profile
• On track for BLA submission in Q4 2025 with potential 2026 launch

Negative

• Increased net loss to $76.5 million in Q2 2025 vs $33.7 million in Q2 2024
• Higher cash burn with $109.2 million used in operations vs $58.6 million year-over-year

Insights

Biotechnology Clinical Researcher

Vera Therapeutics reports positive Phase 3 results for atacicept in IgAN, advancing toward BLA submission and potential 2026 launch.

Vera Therapeutics has achieved a significant clinical milestone with its atacicept program for IgA Nephropathy (IgAN). The company reported impressive efficacy data from its ORIGIN 3 trial, with atacicept demonstrating a 46% reduction in proteinuria from baseline and a statistically significant 42% reduction compared to placebo (p<0.0001). These results not only met the primary endpoint but were consistent with or better than previous trial outcomes.

The clinical significance of these results cannot be overstated. Proteinuria reduction is a validated surrogate marker for kidney disease progression in IgAN, and the magnitude of reduction seen here is clinically meaningful. Atacicept's mechanism as a dual BAFF/APRIL inhibitor represents a novel approach to treating IgAN by targeting the disease's immunological roots rather than just managing symptoms. This positions it as potentially disease-modifying, addressing a critical unmet need.

The company's regulatory strategy appears robust, with plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in Q4 2025. The safety profile described as "favorable and comparable to placebo" strengthens their regulatory case. The initiation of the PIONEER trial to investigate atacicept in broader IgAN cohorts and other glomerular diseases indicates confidence in the drug's mechanism and potential for label expansion beyond the initial indication.

From a development perspective, the company has intelligently designed its clinical program with the ORIGIN Extend study, which both maintains patient access to treatment and collects valuable long-term data that could support full approval following an initial accelerated approval.

Biotechnology Financial Analyst

Strong Phase 3 data supports Vera's BLA submission plans, though increasing cash burn raises questions about commercialization costs.

Vera's financial position shows both strengths and challenges. With $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025, plus an undrawn $500 million credit facility with Oxford Finance, the company appears well-capitalized through its anticipated 2026 commercial launch. This substantial war chest provides strategic flexibility as Vera transitions from clinical-stage to commercial operations.

However, the accelerating cash burn rate is noteworthy. The $109.2 million used in operating activities during the first half of 2025 represents an 86% increase from the $58.6 million used in the same period last year. Similarly, quarterly net losses increased to $76.5 million from $33.7 million year-over-year, a 127% jump. This rising burn rate likely reflects increased clinical trial activities, manufacturing scale-up, and pre-commercial investments.

While the company states their resources are sufficient through commercial launch and beyond, investors should monitor the expenditure trajectory carefully. First commercial launches typically require substantial investment in sales force development, marketing, and market access activities. The expanded clinical program with the PIONEER trial investigating atacicept across multiple indications adds additional financial demands.

The positive Phase 3 data significantly de-risks Vera's lead asset, potentially unlocking partnership or financing opportunities on more favorable terms if needed. The upcoming BLA submission and potential 2026 launch represent critical value inflection points that could transform Vera from a clinical-stage company with negative cash flow to a commercial entity with product revenue.

• On track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to U.S. FDA in Q4 2025; potential commercial launch in 2026
• Announced positive primary endpoint results from the ongoing ORIGIN Phase 3 trial
• Initiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and multiple autoimmune glomerular diseases
• Expected to present full primary endpoint results from the ORIGIN 3 trial at a medical congress in Q4 2025

BRISBANE, Calif., Aug. 05, 2025 (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 second quarter ended June 30, 2025.

“Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better than our previous trials for atacicept in patients with IgAN. Based on the strength of the overall data accumulated for atacicept over the past few years, we are excited to move ahead with our BLA submission to the U.S. FDA for accelerated approval. We anticipate submitting the BLA in the fourth quarter of 2025, with an expected commercial launch in 2026,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We are thrilled for the potential of atacicept as a possible disease-modifying therapy to address the unmet medical needs of IgAN patients.”

Second Quarter 2025 and Recent Business Highlights

• Announced positive 36-week data from the ongoing pivotal ORIGIN 3 trial of atacicept in patients with IgA Nephropathy (IgAN), including:
  • 46% reduction from baseline in proteinuria for participants treated with atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR); primary endpoint achieved with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001)
  • Atacicept-treated participants demonstrated results across other prespecified endpoints that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial
  • Safety profile of atacicept across ORIGIN program appears favorable, and comparable to placebo
• Completed full enrollment in the ongoing ORIGIN 3 trial
• Enrolling participants in the ORIGIN Extend study, which provides ORIGIN study participants with extended access to atacicept until commercial availability in their region, and captures longer-term safety and efficacy data
• Initiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients
• Strengthened the Company’s financial positioning with a new credit facility of up to $500 million of term loans with existing partner Oxford Finance LLC, extending the Company’s cash runway well beyond potential commercial launch of atacicept

Anticipated Upcoming Milestones

• Submission of a BLA for atacicept in IgAN to the U.S. FDA in Q4 2025 for accelerated approval; potential commercial launch in 2026
• Presentation of the full 36-week results from the pivotal ORIGIN 3 trial expected at a medical congress in Q4 2025
• Initial results from the PIONEER Phase 2 basket trial expected in Q4 2025
• Pivotal ORIGIN 3 study expected to be completed in 2027

Financial Results for the Quarter Ended June 30, 2025
For the quarter ended June 30, 2025, Vera reported a net loss of $76.5 million, or a net loss per diluted share of $1.20, compared to a net loss of $33.7 million, or a net loss per diluted share of $0.62, for the quarter ended June 30, 2024.

During the six months ended June 30, 2025, net cash used in operating activities was $109.2 million, compared to $58.6 million for the same period last year.

Vera reported $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which combined with its undrawn debt facility, Vera 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 certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis.

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.

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 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.

About Vera
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also 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 is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept 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, Vera’s plans to submit a Biologics License Application to the U.S. FDA for accelerated approval and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, present full primary endpoint results from the ORIGIN 3 trial at a medical congress, obtain initial results from the PIONEER Phase 2 basket trial, and complete the ORIGIN 3 study, as well as statements regarding the timing of each such event; the ability of atacicept to advance the standard of care in IgAN and to address the unmet medical needs of IgAN patients; Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept; and Vera’s plans, commitments, aspirations and goals under the caption “About Vera”. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believe,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s 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’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s 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 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)
	Three Months Ended								Six Months Ended
	June 30,								June 30,
		2025				2024				2025				2024
Operating expenses:
Research and development	$	58,195			$	29,311			$	99,473			$	52,511
General and administrative		21,946				8,032				37,862				15,944
Total operating expenses		80,141				37,343				137,335				68,455
Loss from operations		(80,141	)			(37,343	)			(137,335	)			(68,455	)
Other income, net		3,610				3,635				9,110				6,364
Net loss	$	(76,531	)		$	(33,708	)		$	(128,225	)		$	(62,091	)
Change in unrealized gain/loss on marketable securities	$	(127	)		$	(277	)		$	134			$	(700	)
Comprehensive loss	$	(76,658	)		$	(33,985	)		$	(128,091	)		$	(62,791	)
Net loss per share attributable to common stockholders, basic and diluted	$	(1.20	)		$	(0.62	)		$	(2.01	)		$	(1.17	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		63,789,303				54,728,552				63,730,756				52,850,242

VERA THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands)
	June 30,				December 31,
		2025				2024
	(unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable securities	$	556,827			$	640,852
Prepaid expenses and other current assets		14,527				10,366
Total current assets		571,354				651,218
Operating lease right-of-use assets		2,471				3,372
Other noncurrent assets		4,703				1,091
Total assets	$	578,528			$	655,681
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	13,157			$	7,665
Operating lease liabilities		855				1,483
Accrued expenses and other liabilities, current		19,542				16,223
Total current liabilities		33,554				25,371
Long-term debt		74,464				50,687
Operating lease liabilities, noncurrent		2,233				2,468
Total liabilities		110,251				78,526
Stockholders' equity
Common stock		64				64
Additional paid-in-capital		1,057,161				1,037,948
Accumulated other comprehensive income		527				393
Accumulated deficit		(589,475	)			(461,250	)
Total stockholders' equity		468,277				577,155
Total liabilities and stockholders' equity	$	578,528			$	655,681

FAQ

What were the key results from Vera Therapeutics' ORIGIN 3 trial for atacicept?

The trial achieved its primary endpoint with a 42% reduction in UPCR compared to placebo (p<0.0001), and showed a 46% reduction in proteinuria from baseline in atacicept-treated participants.

When does Vera Therapeutics (VERA) expect to launch atacicept commercially?

Vera plans to submit its BLA to the FDA in Q4 2025 and expects a potential commercial launch in 2026.

What is Vera Therapeutics' (VERA) current financial position in Q2 2025?

Vera reported $556.8 million in cash and equivalents and secured a $500 million credit facility, which they believe is sufficient to fund operations through potential approval and commercial launch of atacicept.

How did Vera Therapeutics' (VERA) Q2 2025 losses compare to the previous year?

Vera reported a net loss of $76.5 million ($1.20 per share) in Q2 2025, compared to $33.7 million ($0.62 per share) in Q2 2024.

What new clinical trials has Vera Therapeutics initiated for atacicept?

Vera initiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis and minimal change disease patients.