BRISBANE, Calif., Nov. 18, 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 announced the appointment of Jason S. Carter as Chief Legal Officer, effective immediately.

"We are excited to have Jason join our growing team. With our pivotal ORIGIN 3 trial of atacicept in IgAN on track to announce topline results in the second quarter of 2025 and planned BLA submission to the FDA anticipated later in the year, pending data, we are actively building out our team with experienced professionals who will help us successfully enter our next phase as a company," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. "Jason brings a wealth of practical and strategic experience in supporting companies through regulatory approvals, commercialization, and intellectual property management."

"It is a privilege to join the Vera team and be part of the Company's mission to bring safe and effective therapies to patients with high unmet needs," commented Mr. Carter. "I look forward to supporting the advancement of Vera's lead asset, atacicept, as a potential best-in-class disease-modifying treatment option for patients with IgAN, as well as a potential therapy for multiple other autoimmune kidney diseases."

Mr. Carter brings over 20 years of experience as an attorney providing counsel to public and private companies across a wide spectrum of life sciences, biotechnology, and large pharmaceutical companies. Mr. Carter has recently served as Global Head of Legal for Kite Pharma, Inc., where he oversaw legal and compliance activities supporting global product launches, R&D activities, manufacturing innovation and expansion, high-impact IP litigation, and M&A transactions. Prior to Kite, Mr. Carter served in a variety of senior legal roles, including at Daiichi Sankyo, Novartis, and Baxter. Earlier in his career, Mr. Carter practiced as an M&A and corporate securities attorney with Jenner & Block, and Vorys, Sater, Seymour & Pease. Mr. Carter serves on the board of advisors for Family Reach/More Moments More Memories, a leading patient centered non-profit. Mr. Carter holds a J.D. from University of Wisconsin-Madison Law School and a bachelor's degree in political science from Temple University.

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. 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.

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.

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, atacicept's potential to be a disease-modifying treatment option for patients with IgAN, as well as a potential therapy for multiple other autoimmune kidney diseases and Vera's expectations regarding timing of data presentations and regulatory submissions. 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 "will," "may", "plan," "on track," "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