Vera Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results

Rhea-AI Summary

Vera Therapeutics, a biotechnology company, shared positive 72-week data from its Phase 2b ORIGIN clinical trial for IgAN. They reported no kidney function loss with atacicept treatment. They anticipate Phase 3 ORIGIN 3 trial results in 2025. The company completed a $287.5 million financing, strengthening its financial position.

Positive

• Positive 72-week data from Phase 2b ORIGIN trial for IgAN

• Stable eGFR and reductions in Gd-IgA1, hematuria, and UPCR

• Expanded management team with key appointments

• Completed $287.5 million financing in February

Negative

• Net loss of $28.4 million for the quarter ended March 31, 2024

• Increased net loss per diluted share compared to the same period last year

• Net cash used in operating activities rose to $33.8 million

Financial Analyst

Upon reviewing the financial health of Vera Therapeutics, their recent completion of a $287.5 million financing round marks a significant bolstering of their balance sheet. The company's reported cash and equivalents of $403.7 million are noteworthy as they are believed to extend the company's operational reach through not only the regulatory approval process but also the commercial launch of Atacicept. This capital injection and extended runway may mitigate near-term dilution risks for shareholders and provide a cushion for unforeseeable R&D expenditures or delays.

However, the reported net loss of $28.4 million for the quarter, an increase in cash burn from $26.3 million in the prior year, indicates ongoing heavy investment in their pipeline, specifically in advancing Atacicept through clinical trials. Investors should track whether these investments translate into regulatory successes and market penetrations that would justify the spending.

Biotech Industry Analyst

The positive 72-week data from the Phase 2b ORIGIN trial for Atacicept in IgAN patients is a promising development for Vera Therapeutics. IgAN, or immunoglobulin A nephropathy, is a chronic kidney disease with limited treatment options, thus making any successful treatment potential a noteworthy advancement. The market for IgAN treatments is not saturated, providing a lucrative opportunity for new entrants like Vera with effective therapies.

The anticipation of Phase 3 trial completion and subsequent regulatory approval decisions carries major weight for the stock valuation. Given the complexity and risks inherent in the biotech sector, it is important to assess not only the clinical data but also the market potential of Atacicept in comparison to existing treatments. The extended timeline to potential approval and launch does mean that investors will require patience and tolerance for interim fluctuations based on clinical trial updates.

Clinical Trial Expert

The progress of Atacicept through the clinical trial pipeline is a pivotal aspect of Vera Therapeutics' valuation. The ORIGIN Phase 2b trial has shown consistency in its endpoints, a positive signal for the drug's efficacy and safety profile. While these are promising results, the drug's ultimate approval will hinge upon the success of the upcoming pivotal Phase 3 trial. The Phase 3 trial's completion and topline data expected in the first half of 2025 represents the next major inflection point for the company.

For retail investors, the differentiation of this treatment in terms of its ability to stop kidney function decline could be a game-changer in the nephrology space. However, understanding that late-stage clinical trials and subsequent steps toward commercialization are filled with regulatory challenges is essential. The trial's success is critical, but so is the strategic readiness for market access and competition within the nephrology space post-approval.

• Presented positive 72-week data from the Phase 2b ORIGIN clinical trial, setting a new standard in IgAN with no loss of kidney function over the duration of treatment
  
• Topline 96-week data from ORIGIN 2 trial expected in Q4 2024
• Pivotal Phase 3 ORIGIN 3 trial estimated to complete enrollment for primary endpoint in Q3 2024; topline data expected in 1H 2025
• Completed $287.5 million financing, further strengthening the Company’s balance sheet

BRISBANE, Calif., May 09, 2024 (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, 2024.

“This quarter, we shared results from our Phase 2b clinical trial that demonstrated for the first time in this field that atacicept can resolve kidney inflammation and stop kidney function decline in young patients with IgAN who are at risk of kidney failure, offering a potentially transformative treatment for these young patients,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Later this year we plan to announce long-term 96-week clinical data from our ORIGIN 2b trial, and in the first half 2025 we anticipate reading out the primary endpoint results from our pivotal ORIGIN Phase 3 trial, which are expected to support our submission for regulatory approval of atacicept. We look forward to providing updates of our progress leading up to these significant events.”

First Quarter and Recent Business Highlights

• Presented positive 72-week data from ORIGIN Phase 2b trial of atacicept in IgAN that show consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with stable eGFR over the duration of treatment
• Expanded management team with key appointments, including industry veterans Robert M. Brenner, M.D., as Chief Medical Officer and William D. Turner as Chief Development Officer
• Actively adding sites and enrolling pivotal Phase 3 ORIGIN 3 study of atacicept for the treatment of IgAN
• Completed $287.5 million financing in February, further strengthening the Company’s balance sheet with $403.7 million in cash and equivalents as of March 31, 2024 and extending the Company’s expected cash runway through potential approval and commercial launch

Upcoming Milestones in 2024

• Two abstracts selected for oral presentations – including “Best-Ranked Abstract” – at the 61st European Renal Association Congress (ERA24) on May 25, 2024
• Plan to present topline 96-week data from ORIGIN Ph 2b clinical trial of atacicept in IgAN in the fourth quarter of 2024
• Pivotal Phase 3 ORIGIN 3 trial estimated to complete enrollment in the third quarter of 2024; on track to announced preliminary data in the first half of 2025
  

Financial Results for the Quarter Ended March 31, 2024
For the quarter ended March 31, 2024, the company reported a net loss of $28.4 million, or a net loss per diluted share of $0.56, compared to a net loss of $30.1 million, or a net loss per diluted share of $0.80, for the same period last year.

During the quarter ended March 31, 2024, net cash used in operating activities was $33.8 million, compared to $26.3 million for the same period last year.

Vera reported $403.7 million in cash, cash equivalents, and marketable securities as of March 31, 2024, which the Company believes to be sufficient to fund operations through approval and US commercial launch of atacicept.

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 and plasma 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. For more information, please visit www.veratx.com.

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. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications.

About MAU868
MAU868, a potential first-in-class monoclonal antibody, has the potential to neutralize infection by blocking BKV virions from binding to host cells. BKV is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant. It is a leading cause of kidney transplant loss and transplant-associated morbidity; there are currently no approved treatments for BKV. Vera holds an exclusive worldwide license from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., for the development and commercialization of MAU868 in all indications.

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 anticipated presentations at the European Renal Association Congress (ERA24), and Vera’s product candidates, strategy, and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “potential,” “will,” “plan,” 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:
Mari Purpura
LifeSci Advisors
mpurpura@lifesciadvisors.com

VERA THERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
	Three Months Ended
	March 31,
		2024				2023
	(unaudited)
Operating expenses:
Research and development	$	23,200			$	25,108
General and administrative		7,912				6,150
Total operating expenses		31,112				31,258
Loss from operations		(31,112)				(31,258)
Other income, net		2,729				1,189
Net loss	$	(28,383)			$	(30,069)
Change in unrealized gain(loss) on marketable securities	$	(424)			$	220
Comprehensive loss	$	(28,807)			$	(29,849)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.56)			$	(0.80)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		50,971,933				37,667,566

VERA THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands)
	March 31,				December 31,
		2024				2023
	(unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable securities	$	403,664			$	160,716
Prepaid expenses and other assets, current		12,706				11,307
Total current assets		416,370				172,023
Operating lease right-of-use assets		2,432				2,949
Other noncurrent assets		554				574
Total assets	$	419,356			$	175,546
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	5,209			$	11,118
Operating lease liabilities		2,275				2,436
Accrued expenses and other liabilities, current		7,059				8,749
Total current liabilities		14,543				22,303
Long-term debt		50,066				49,877
Operating lease liabilities, noncurrent		919				1,395
Accrued and other noncurrent liabilities		286				286
Total liabilities		65,814				73,861
Stockholders' equity
Common stock		54				44
Additional paid-in-capital		691,146				410,492
Accumulated other comprehensive income (loss)		(173)				251
Accumulated deficit		(337,485)				(309,102)
Total stockholders' equity		353,542				101,685
Total liabilities and stockholders' equity	$	419,356			$	175,546

FAQ

What positive data did Vera Therapeutics share from the Phase 2b ORIGIN clinical trial?

Vera Therapeutics shared positive 72-week data from the Phase 2b ORIGIN clinical trial for IgAN, showing no loss of kidney function with atacicept treatment.

What financing activity did Vera Therapeutics complete in February?

Vera Therapeutics completed a $287.5 million financing in February, strengthening its financial position.

What was Vera Therapeutics' net loss for the quarter ended March 31, 2024?

Vera Therapeutics reported a net loss of $28.4 million for the quarter ended March 31, 2024.