- Company makes ongoing progress in several areas evaluating atacicept, its lead product candidate
- Phase 2a JANUS clinical trial showed atacicept administered subcutaneously once weekly demonstrated a durable and substantial reduction in serum galactose-deficient IgA1 (Gd-IgA1) in a dose-dependent manner up to 72 weeks in patients with IgA nephropathy
- Vera reported approximately $86.2 million in cash and cash equivalents as of September 30, 2021
SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients’ lives, today reported its business highlights and financial results for the quarter ending September 30, 2021, and provided a corporate update.
“Vera’s third-quarter highlights show continued progress on our business objectives. We remain well-positioned as we continue to advance the clinical program for atacicept, evaluating its potential for patients who suffer from the devastating effects of kidney disease and are lacking effective treatment options,” said Marshall Fordyce, MD, founder and CEO of Vera Therapeutics. “We are pleased by the analysis of our Phase 2a study demonstrating atacicept 75mg reduces Gd-IgA1 to the lowest risk quartile. We continue to make progress enrolling our ongoing Phase 2b ORIGIN study of atacicept in patients with IgA nephropathy – a study powered for proteinuria, and designed to demonstrate atacicept as the first disease-modifying therapy for this indication. We also look forward to the response from the FDA in the fourth quarter of 2021 on our proposed clinical development strategy for atacicept to treat lupus nephritis.”
Third Quarter and Recent Business Highlights
- Phase 2a JANUS clinical trial data presented at American Society of Nephrology’s 2021 Kidney Week showed that atacicept, administered subcutaneously once weekly, demonstrated a substantial reduction in serum galactose-deficient IgA1 (Gd-IgA1) in a dose-dependent manner that was durable through 72 weeks in patients with IgA nephropathy (IgAN). New analysis of these results initially divided JANUS patients into four equal groups according to the quartiles of serum Gd-IgA1 distribution at baseline. Quartile level was then assessed at each timepoint. This additional analysis showed that atacicept decreased serum Gd-IgA1 levels by up to two quartiles. The largest effect was seen in the atacicept 75mg arm where after 24 weeks all study patients had reductions in serum Gd-IgA1 to the lowest risk quartiles, which is associated with the most favorable renal survival.
- Similar results were reported in Vera’s key opinion leader (KOL) webinar – featuring Dr. Richard Lafayette of Stanford University Medical Center and Dr. Jonathan Barratt of the University of Leicester – who discussed the rationale for targeting dual inhibition of APRIL/BlyS and the potential of atacicept as a disease-modifying treatment option. The webinar reported that a 75mg atacicept dose lowered serum Gd-IgA1 levels by 60 percent compared to baseline – the largest reduction demonstrated in a randomized placebo-controlled study by an investigational compound in development for IgAN.
- Vera also reported ongoing progress in the Phase 2b ORIGIN study evaluating the safety and efficacy of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression.
“Research has shown that higher levels of Gd-IgA1 are associated with increased risk of end-stage renal disease or death. The new analysis from the Phase 2a JANUS clinical trial presented at Kidney Week 2021 showed that atacicept substantially reduced Gd-IgA1. We are optimistic for even greater efficacy and durability from the 150mg dose of atacicept in the ORIGIN study and look forward to providing initial results from the ORIGIN trial in the fourth quarter of 2022,” added Dr. Fordyce.
Financial Results for the Quarter Ended September 30, 2021
For the three months ended September 30, 2021, the company reported a net loss of $7.6 million, or a net loss per diluted share of $0.36, compared to a net loss of $4.5 million, or a net loss per diluted share of $13.68, for the same period last year. Outstanding shares of redeemable convertible preferred stock were excluded from the computation of net loss per diluted share for periods prior to the conversion of those shares to common stock in May 2021.
During the nine months ended September 30, 2021, net cash used in operating activities was $17.3 million, compared to $7.4 million for the same period last year.
Vera reported approximately $86.2 million in cash and cash equivalents as of September 30, 2021.
Atacicept is a novel, disease-modifying fully humanized fusion protein that is a dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) 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 immunologic diseases, including IgA nephropathy (IgAN), also known as Berger’s disease, and systemic lupus erythematosus. Vera believes that atacicept has the potential to be the best-in-class and the leading B cell-targeted therapy for IgAN. Atacicept has been well tolerated and has been used in clinical trials of more than 1,500 patients to date. In a clinical trial of IgAN patients, data show atacicept is the first known molecule to substantially reduce galactose-deficient immunoglobulin A (Gd-IgA1).
Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic 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 lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN). For more information, please visit www.veratx.com.
Statements contained in this press release regarding matters that are not historical facts 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, the clinical development and regulatory review process of atacicept and the timing of results from the ORIGIN trial. 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 “plans,” “will”, “anticipates,” “goal,” “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 and uncertainties associated with Vera’s business in general, the impact of the COVID-19 pandemic, 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.
Greig Communications, Inc.
|VERA THERAPEUTICS, INC.|
|Unaudited Condensed Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||3,564||$||1,969||$||9,731||$||5,362|
|General and administrative||3,688||652||8,086||2,903|
|Total operating expenses||7,252||4,037||17,817||9,681|
|Loss from operations||(7,252||)||(4,037||)||(17,817||)||(9,681||)|
|Total other income (expense), net||(359||)||(423||)||2,055||(857||)|
|Net loss and comprehensive loss||$||(7,611||)||$||(4,460||)||$||(15,762||)||$||(10,538||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.36||)||$||(13.68||)||$||(1.46||)||$||(32.64||)|
|Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted||21,265,519||325,985||10,793,436||322,811|
|VERA THERAPEUTICS, INC.|
|Unaudited Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||86,191||$||53,654|
|Restricted cash, current||-||50|
|Prepaid expenses and other current assets||3,569||557|
|Total current assets||89,760||54,261|
|Restricted cash, noncurrent||293||293|
|Non-marketable equity securities||1,114||-|
|Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)|
|Restructuring liability, current||367||962|
|Accrued expenses and other current liabilities||2,711||535|
|Total current liabilities||4,042||2,406|
|Restructuring liability, noncurrent||1,362||1,634|
|Accrued and other noncurrent liabilities||286||286|
|Redeemable convertible preferred stock||-||139,576|
|Stockholders' equity (deficit)|
|Total stockholders' equity (deficit)||85,477||(89,348||)|
|Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)||$||91,167||$||54,554|