Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Vera Therapeutics (NASDAQ: VERA) provided its Q4 and full year 2024 business update, highlighting progress in its atacicept development program for IgA Nephropathy (IgAN). The company is on track to announce primary endpoint results from the pivotal Phase 3 ORIGIN trial in Q2 2025, with BLA submission planned for H2 2025.

Key developments include receiving FDA Breakthrough Therapy Designation for atacicept in IgAN and presenting positive 96-week eGFR stabilization data. Vera expanded atacicept's development pipeline to include multiple autoimmune kidney diseases and acquired rights to VT-109, a next-generation fusion protein.

Financial highlights show a net loss of $152.1 million ($2.75 per share) for 2024, compared to $96.0 million ($2.25 per share) in 2023. The company reported $640.9 million in cash and equivalents, strengthened by approximately $593.2 million in net proceeds from two equity financings in 2024.

Positive

• FDA Breakthrough Therapy Designation received for atacicept in IgAN
• Positive 96-week eGFR stabilization data in Phase 2b trial
• Strong cash position of $640.9M sufficient through potential approval and launch
• Successful equity financing raising $593.2M net proceeds
• Pipeline expansion to multiple autoimmune kidney diseases

Negative

• Net loss increased to $152.1M from $96.0M year-over-year
• Cash burn increased: operating cash use $134.7M vs $92.2M prior year

Insights

Financial Analyst

Vera Therapeutics is approaching a pivotal inflection point with its lead candidate atacicept for IgA Nephropathy (IgAN), a serious autoimmune kidney disease with treatment options. The anticipated primary endpoint readout from the Phase 3 ORIGIN trial in Q2 2025 represents a critical catalyst that could transform the company's trajectory.

The 96-week eGFR stabilization data presented at ASN Kidney Week 2024 strengthens atacicept's clinical profile, as kidney function preservation is the ultimate goal of IgAN therapy. This positive data, coupled with the FDA's Breakthrough Therapy Designation, significantly enhances the probability of regulatory success for the planned BLA submission in 2H 2025.

Vera's strategic pipeline expansion beyond IgAN to include primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease substantially increases atacicept's market potential. This multi-indication strategy could create a franchise across autoimmune kidney diseases, potentially multiplying the addressable market.

The financial picture shows both increased investment and prudent preparation for commercialization. While the $152.1 million net loss (58% higher than 2023) reflects accelerated spending on late-stage clinical development, the company has secured a robust $640.9 million cash position through two strategic financings. This provides an estimated runway beyond commercial launch, reducing financing risk during a critical transition period.

The appointment of seasoned executives with commercialization expertise in regulatory affairs (William Turner), operations (David Johnson), and clinical development (Dr. Robert Brenner) signals preparation for market entry. The acquisition of VT-109, a next-generation fusion protein targeting BAFF and APRIL, also provides pipeline diversification beyond atacicept.

As Vera approaches potential commercialization in 2026, the company has positioned itself with the financial resources, leadership team, and clinical data needed to potentially establish atacicept as a first-line therapy for IgAN and potentially other autoimmune kidney diseases.

Biotechnology Specialist

Atacicept represents a potentially transformative approach to treating IgA Nephropathy through its dual inhibition of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), two key cytokines driving the pathogenesis of IgAN. This dual-targeting mechanism differentiates atacicept from other therapies in development that typically target only single pathways.

The 96-week eGFR stabilization data from the Phase 2b ORIGIN trial is particularly compelling as it demonstrates atacicept's potential to preserve kidney function long-term. Most current IgAN treatments focus on proteinuria reduction without directly addressing the underlying immunological mechanisms driving disease progression. Atacicept's ability to potentially halt the decline in kidney function addresses the core clinical need in IgAN management.

Vera's strategic expansion into primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) is scientifically sound. These conditions share pathophysiological features with IgAN, including B-cell dysregulation and antibody-mediated kidney damage. The planned PIONEER trial will specifically target anti-PLA2R positive PMN and anti-nephrin positive FSGS/MCD patients, using biomarkers to identify those most likely to respond - a precision medicine approach that could enhance clinical success rates.

The QM (quarterly) dose finding study planned for 2025 represents a significant potential advantage for atacicept. Extended dosing could dramatically improve patient adherence compared to more frequent administration schedules of competing therapies, potentially establishing atacicept as the preferred option in real-world settings.

The acquisition of VT-109, a next-generation fusion protein also targeting BAFF/APRIL, creates pipeline depth and potential lifecycle management opportunities. While atacicept is a dual-domain fusion protein (TACI-Ig), VT-109 likely incorporates engineering optimizations that could enhance potency, selectivity, or pharmacokinetic properties.

Vera's pursuit of the accelerated approval pathway based on proteinuria reduction is strategically sound, as this surrogate endpoint has been accepted by the FDA for other kidney disease therapies. However, the company is wisely collecting extended eGFR data through the ORIGIN Extend study, which will be important for full approval and broader adoption by nephrologists who prioritize kidney function preservation.

• On track to announce the primary endpoint result from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; BLA submission to the U.S. FDA for accelerated approval planned in 2H 2025
• Expanded atacicept clinical development program in multiple autoimmune kidney diseases proceeding in 2025
• Strengthened balance sheet to support clinical pipeline development, planned FDA submission, and potential 2026 commercial launch of atacicept for the treatment of IgAN
  

BRISBANE, Calif., Feb. 26, 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 fourth quarter and full year ended December 31, 2024.

“Vera is poised to change the standard of care in autoimmune diseases with atacicept, our investigational therapy, beginning with IgA nephropathy. We are on track to announce the primary endpoint result of the ORIGIN Phase 3 study in the second quarter of this year. We look forward to submitting a Biologics License Application (BLA) for this potential best-in-class therapy in the second half of this year. We are grateful to the study investigators and participants for their ongoing and enthusiastic participation in this program,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “In addition, over the past year we have made progress advancing our broader development pipeline, including additional potential indications for atacicept.”

Fiscal 2024 and Recent Business Highlights

• Received FDA Breakthrough Therapy Designation for atacicept in IgAN
• Presented positive data showing eGFR stabilization over 96 weeks in the ORIGIN Phase 2b clinical trial of atacicept in IgAN in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2024, and in a simultaneous peer-reviewed publication in the Journal of the American Society of Nephrology
• Initiated the ORIGIN Extend study, providing ORIGIN 2b/3 participants with extended access to atacicept and capturing longer-term safety and efficacy data
• Announced an expanded development pipeline for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) beginning in 2025
• Acquired exclusive rights 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
• Completed two equity financings in 2024, for a total of approximately $593.2 million in net proceeds, further bolstering the balance sheet ahead of potential regulatory submission and commercial launch
• Appointed multiple industry veterans to the leadership team, including Robert Brenner, M.D., as Chief Medical Officer, William Turner as Chief Regulatory Officer, David Johnson as Chief Operating Officer, and Jason Carter as Chief Legal Officer, throughout 2024
  

Major Upcoming Milestones

• Planned updates from the ongoing pivotal ORIGIN 3 trial:
  • Anticipate full enrollment in 2Q 2025
  • On track to announce the primary endpoint result in 2Q 2025
• Plan to submit a BLA to the U.S. FDA in 2H 2025 for atacicept in IgAN for accelerated approval assuming supportive data; and would expect a PDUFA date and commercial launch in 2026
• QM dose finding study initiating in 2025 to evaluate extended dosing
• Plan to initiate the PIONEER trial in 2025, which would evaluate atacicept in expanded IgAN populations and anti-PLA2R positive PMN and anti-nephrin positive FSGS and MCD

Financial Results for the Quarter and Year Ended December 31, 2024
For the year ended December 31, 2024, the company reported a net loss of $152.1 million, or a net loss per diluted share of $2.75, compared to a net loss of $96.0 million, or a net loss per diluted share of $2.25, for the year ended December 31, 2023.

During the year ended December 31, 2024, net cash used in operating activities was $134.7 million, compared to $92.2 million for the same period last year.

Vera reported $640.9 million in cash, cash equivalents, and marketable securities as of December 31, 2024, 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 complete enrollment and to receive and report primary endpoint result in the Phase 3 ORIGIN 3 trial, to submit a Biologics License Application to the FDA, and to potentially receive a PDUFA date, receive FDA approval for atacicept in IgAN and launch it commercially, 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 “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 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)
(Unaudited)
		For the Year Ended December 31,
			2024				2023
Operating expenses:
Research and development		$	126,172			$	78,225
General and administrative			40,998				23,787
Total operating expenses			167,170				102,012
Loss from operations			(167,170	)			(102,012	)
Other income, net			15,022				6,023
Provision for income taxes			(1	)			(1	)
Net loss		$	(152,149	)		$	(95,990	)
Change in unrealized gain/loss on marketable securities			142				251
Comprehensive loss		$	(152,007	)		$	(95,739	)
Net loss per share attributable to common stockholders, basic and diluted		$	(2.75	)		$	(2.25	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted			55,326,680				42,707,072

 

VERA THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands)
(Unaudited)
	December 31,
		2024				2023
Assets
Current assets:
Cash, cash equivalents and marketable securities	$	640,852			$	160,716
Prepaid expenses and other current assets		10,366				11,307
Total current assets		651,218				172,023
Operating lease right-of-use assets		3,372				2,949
Other noncurrent assets		1,091				574
Total assets	$	655,681			$	175,546
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	7,665			$	11,118
Operating lease liabilities		1,483				2,436
Accrued expenses and other liabilities, current		16,223				8,749
Total current liabilities		25,371				22,303
Long-term debt		50,687				49,877
Operating lease liabilities, noncurrent		2,468				1,395
Accrued expenses and other liabilities, noncurrent		-				286
Total liabilities		78,526				73,861
Stockholders' equity
Common stock		64				44
Additional paid-in-capital		1,037,948				410,492
Accumulated other comprehensive income		393				251
Accumulated deficit		(461,250	)			(309,102	)
Total stockholders' equity		577,155				101,685
Total liabilities and stockholders' equity	$	655,681			$	175,546

FAQ

When will Vera Therapeutics (VERA) announce Phase 3 ORIGIN trial results for atacicept?

Vera will announce the primary endpoint results from the Phase 3 ORIGIN trial in Q2 2025.

What was Vera Therapeutics' (VERA) net loss for full year 2024?

Vera reported a net loss of $152.1 million, or $2.75 per diluted share, for the year ended December 31, 2024.

How much cash does Vera Therapeutics (VERA) have as of December 2024?

Vera reported $640.9 million in cash, cash equivalents, and marketable securities as of December 31, 2024.

When does Vera Therapeutics (VERA) plan to submit the BLA for atacicept in IgAN?

Vera plans to submit the Biologics License Application (BLA) to the FDA in the second half of 2025.

What new indications is Vera Therapeutics (VERA) exploring for atacicept in 2025?

Vera is expanding atacicept development to primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD).