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

Rhea-AI Summary

Vera Therapeutics (NASDAQ: VERA) provided its Q1 2025 business update, highlighting significant progress in its atacicept development program. The company is approaching a crucial milestone with upcoming primary endpoint results from the pivotal Phase 3 ORIGIN trial for IgA Nephropathy (IgAN) in Q2 2025, followed by planned BLA submission to FDA in Q4 2025.

Financial results showed a net loss of $51.7 million ($0.81 per share) compared to $28.4 million ($0.56 per share) in Q1 2024. The company maintains a strong financial position with $589.8 million in cash and equivalents, deemed sufficient to fund operations through potential approval and U.S. commercial launch.

Vera has expanded its atacicept development program across multiple autoimmune kidney diseases and acquired rights to VT-109, a novel fusion protein targeting BAFF and APRIL.

Positive

• Strong cash position of $589.8 million, sufficient for operations through potential approval and launch
• On track for potential commercial launch in 2026
• Expansion of development program across multiple autoimmune kidney diseases
• Acquisition of VT-109 rights expands pipeline potential

Negative

• Increased net loss to $51.7 million in Q1 2025 from $28.4 million in Q1 2024
• Higher cash burn with $54.4 million used in operations vs $33.8 million year-over-year

Insights

Biotechnology Analyst

Vera approaches pivotal Phase 3 atacicept readout with strong cash position; expanded kidney disease program diversifies opportunity amid increasing burn rate.

Vera Therapeutics is rapidly approaching a transformative milestone with their atacicept program for IgA Nephropathy (IgAN). The pivotal Phase 3 ORIGIN trial has completed enrollment with primary endpoint results expected in Q2 2025 - just weeks away. This represents a classic binary event for a clinical-stage biotech company, where positive data could unlock significant value through their planned BLA submission targeted for Q4 2025.

What's particularly noteworthy is Vera's strategic expansion of atacicept beyond IgAN into multiple related kidney conditions including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). This indicates confidence in atacicept's mechanism targeting B cell-mediated autoimmunity, which underlies multiple kidney disorders. This basket approach maximizes the potential return on their R&D investment and reduces the risk of being a one-indication company.

The acquisition of VT-109, a novel fusion protein also targeting BAFF and APRIL pathways, further demonstrates pipeline expansion while staying within their immunological expertise. The company is clearly positioning itself as a specialist in B cell-mediated kidney diseases rather than a single-asset organization.

Their $589.8 million cash position is substantial for a company of this size and stage, providing runway through potential approval and commercial launch. The accelerated approval pathway for atacicept could enable commercialization as early as 2026 if successful. However, the increased quarterly loss of $51.7 million (up from $28.4 million year-over-year) and higher cash burn reflect the substantial investments required at this critical late-stage development phase.

Financial Analyst

Vera's expanding pipeline and strong cash position counterbalance increasing losses; upcoming Phase 3 data represents decisive near-term catalyst.

Vera Therapeutics presents an intriguing financial profile with both encouraging and cautionary indicators. The company's $589.8 million cash reserve represents exceptional runway for a clinical-stage biotech, with management explicitly stating it's sufficient to fund operations through potential approval and commercial launch of atacicept. This removes near-term financing risk, a significant advantage in the current biotech funding environment.

However, investors should note the accelerating cash burn rate. Net cash used in Q1 2025 operations increased to $54.4 million, up substantially from $33.8 million in the comparable period. Similarly, net losses widened to $51.7 million ($0.81 per share) from $28.4 million ($0.56 per share) year-over-year. This 82% increase in quarterly losses reflects the substantial costs of late-stage clinical development and likely pre-commercial preparations.

At the current burn rate, the cash position equates to approximately 10-11 quarters of runway, validating management's assertion of funding through potential approval and launch in 2026. This financial cushion provides crucial flexibility should any regulatory timelines extend beyond current projections.

The company's strategy of expanding atacicept across multiple kidney diseases represents efficient capital allocation, leveraging a single asset across several indications with similar underlying mechanisms. This approach, combined with the addition of VT-109, creates multiple value-driving opportunities beyond the lead IgAN program.

From an investment perspective, the upcoming Phase 3 ORIGIN data expected in Q2 2025 represents the definitive near-term catalyst. This binary event will likely drive significant price movement regardless of outcome, with successful data potentially triggering substantial value creation as the company transitions toward potential commercialization in 2026.

• On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics License Application (BLA) submission for atacicept accelerated approval to the U.S. FDA in 4Q 2025
• Expanded atacicept development program across multiple autoimmune kidney diseases is underway

BRISBANE, Calif., May 06, 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 first quarter ended March 31, 2025.

“We are rapidly approaching a significant Vera milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, and if successful, we expect this to enable a BLA submission to the FDA in the second half of this year, which may allow approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.”

First Quarter 2025 and Recent Business Highlights

• Completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgAN
• Enrolling participants in the ORIGIN EXTEND study, which provides participants in the ORIGIN Phase 2b or Phase 3 trials with extended access to atacicept, and captures longer-term safety and efficacy data
• Acquired exclusive development and commercialization rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across the spectrum of B cell mediated diseases
• Introduced an expanded development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD)

Major Upcoming Milestones

• Anticipated announcement of the primary endpoint results from the pivotal ORIGIN 3 trial in 2Q 2025
• Plan to submit a Biologics License Application (BLA) for atacicept in IgAN to the U.S. FDA in 4Q 2025 for accelerated approval; potential PDUFA date and commercial launch in 2026

Financial Results for the Quarter Ended March 31, 2025
For the quarter ended March 31, 2025, the company reported a net loss of $51.7 million, or a net loss per share of $0.81, compared to a net loss of $28.4 million, or a net loss per diluted share of $0.56, for the quarter ended March 31, 2024.

During the quarter ended March 31, 2025, net cash used in operating activities was $54.4 million, compared to $33.8 million for the same period last year.

Vera reported $589.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept.

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 and lupus nephritis.

The Phase 2b ORIGIN 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 reductions 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 Phase 2b ORIGIN 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 studies across different indications.

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 B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. 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. 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. 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 receive and report primary endpoint results in the Phase 3 ORIGIN 3 trial, to submit a BLA to the FDA, and to potentially receive a PDUFA date, receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept. 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 “anticipate,” “believe,” “on track,” “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 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:
Madelin Hawtin
LifeSci Communications
MHawtin@lifescicomms.com

VERA THERAPEUTICS, INC. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)
	Three Months Ended
	March 31,
		2025				2024
	(unaudited)
Operating expenses:
Research and development	$	41,278			$	23,200
General and administrative		15,916				7,912
Total operating expenses		57,194				31,112
Loss from operations		(57,194	)			(31,112	)
Other income, net		5,500				2,729
Net loss	$	(51,694	)		$	(28,383	)
Change in unrealized gain/loss on marketable securities	$	261			$	(424	)
Comprehensive loss	$	(51,433	)		$	(28,807	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.81	)		$	(0.56	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		63,671,558				50,971,933

VERA THERAPEUTICS, INC. Condensed Balance Sheets (in thousands)
	March 31,				December 31,
		2025				2024
	(unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable securities	$	589,834			$	640,852
Prepaid expenses and other current assets		16,242				10,366
Total current assets		606,076				651,218
Operating lease right-of-use assets		2,915				3,372
Other noncurrent assets		1,176				1,091
Total assets	$	610,167			$	655,681
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	9,262			$	7,665
Operating lease liabilities		1,191				1,483
Accrued expenses and other liabilities, current		11,441				16,223
Total current liabilities		21,894				25,371
Long-term debt		50,908				50,687
Operating lease liabilities, noncurrent		2,366				2,468
Total liabilities		75,168				78,526
Stockholders' equity
Common stock		64				64
Additional paid-in-capital		1,047,225				1,037,948
Accumulated other comprehensive income		654				393
Accumulated deficit		(512,944	)			(461,250	)
Total stockholders' equity		534,999				577,155
Total liabilities and stockholders' equity	$	610,167			$	655,681

FAQ

What are the key upcoming milestones for Vera Therapeutics (VERA) in 2025?

Vera expects to announce primary endpoint results from the Phase 3 ORIGIN trial in Q2 2025 and plans to submit a BLA for atacicept to the FDA in Q4 2025.

What was Vera Therapeutics' (VERA) net loss in Q1 2025?

Vera reported a net loss of $51.7 million, or $0.81 per share, compared to $28.4 million, or $0.56 per share, in Q1 2024.

How much cash does Vera Therapeutics (VERA) have as of Q1 2025?

Vera reported $589.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025.

What is atacicept being developed for by Vera Therapeutics?

Atacicept is being developed primarily for IgA Nephropathy (IgAN), with expanded development across other autoimmune kidney diseases including PMN, FSGS, and MCD.

When does Vera Therapeutics (VERA) expect potential commercial launch of atacicept?

Vera anticipates potential commercial launch of atacicept in 2026, following potential FDA approval.