Vera Therapeutics, Inc. - VERA STOCK NEWS

Vera Therapeutics (Nasdaq: VERA) announced an expansion of its development pipeline for atacicept, its lead asset. The company plans to extend the drug's application beyond IgA nephropathy (IgAN) to other autoimmune kidney diseases. Key points include:

1. ORIGIN Extend: A study providing extended access to atacicept for ORIGIN participants, starting Q4 2024.

2. PIONEER Study: Planned for 2025, evaluating atacicept in expanded IgAN populations and other autoimmune glomerular diseases.

3. The combined peak prevalence of target diseases in the US is estimated at ~230,000.

4. 96-week data from the Phase 2b ORIGIN study will be presented at the American Society of Nephrology Kidney Week 2024.

Vera Therapeutics (Nasdaq: VERA) has announced an in-person and virtual R&D Day on October 2, 2024, in New York. The event will focus on potential indication expansion for atacicept, their lead drug candidate. Notable experts, including Dr. Jonathan Barratt, Dr. Richard Lafayette, and Dr. Brad Rovin, will join Vera's management team to discuss expanded atacicept R&D activities.

This event precedes the anticipated 96-week data from the Phase 2b ORIGIN study of atacicept in immunoglobulin A nephropathy (IgAN), scheduled for presentation at a medical congress in Q4 2024. Notably, atacicept has received FDA Breakthrough Therapy Designation for IgAN treatment, indicating its potential for substantial improvement over existing therapies based on Phase 2b ORIGIN trial data.

Vera Therapeutics (Nasdaq: VERA) has completed enrollment for the primary endpoint in its pivotal Phase 3 ORIGIN 3 trial of atacicept in IgA Nephropathy (IgAN) patients. The trial enrolled 200 participants, with topline results expected in Q2 2025. The company plans to present 96-week data from the Phase 2b ORIGIN trial in Q4 2024. Atacicept has shown promising results in stabilizing kidney function and reducing hematuria, potentially transforming IgAN treatment. The FDA granted atacicept Breakthrough Therapy Designation earlier this year. Vera believes atacicept could be among the first B cell modulators approved for IgAN, offering a new foundation for treating this organ-threatening disease.

Vera Therapeutics (Nasdaq: VERA) announced inducement awards for two new employees on September 5, 2024. The awards, approved by the Compensation Committee under Nasdaq Listing Rule 5635(c)(4), include:

1. A non-qualified stock option to purchase 21,750 shares of Class A common stock

2. Restricted stock units (RSUs) for 9,875 shares of Class A common stock

The stock option has an exercise price of $38.16 per share, based on Vera's closing price on September 5, 2024. It will vest over four years, with 25% vesting on the first anniversary and the remainder monthly over 36 months. The RSUs will vest over four years, with 25% vesting annually starting November 20, 2024. Both awards are subject to continued employment and the terms of the Inducement Plan and award agreements.

Vera Therapeutics (Nasdaq: VERA), a late clinical-stage biotech company, announced its participation in two investor conferences in September 2024. The company, which focuses on developing treatments for serious immunological diseases, will attend:

1. Wells Fargo Healthcare Conference on September 5 in Boston, MA, participating in one-on-one meetings.

2. Cantor Global Healthcare Conference on September 18 in New York, NY, featuring a fireside chat at 9:10am EDT and one-on-one meetings.

A webcast of the Cantor conference presentation will be available, with a 90-day replay accessible on Vera Therapeutics' website in the 'Investor Calendar' section.

Vera Therapeutics (Nasdaq: VERA) has announced inducement awards for three new employees, approved by the Compensation Committee on August 6, 2024. The awards include:

1. A non-qualified stock option to purchase 33,000 shares of Class A common stock

2. Restricted stock units (RSUs) for 16,500 shares of Class A common stock

The stock option has an exercise price of $37.44 per share, equal to Vera's closing trading price on August 6, 2024. Both the stock options and RSUs will vest over four years, with specific vesting schedules. These awards are subject to the terms and conditions of the Inducement Plan and applicable award agreements.

Vera Therapeutics (VERA) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. FDA granted Breakthrough Therapy Designation for atacicept in IgA Nephropathy (IgAN).

2. Presented Phase 2b ORIGIN study data at ERA24 Congress, showing atacicept stabilized kidney function through 72 weeks.

3. Topline 96-week data from Phase 2b ORIGIN study expected in Q4 2024.

4. On track to complete enrollment in pivotal Phase 3 ORIGIN 3 trial in Q3 2024; topline data expected in Q2 2025.

5. Q2 2024 net loss of $33.7 million, or $0.62 per diluted share.

6. Cash position of $384.4 million as of June 30, 2024, believed sufficient to fund operations through approval and US commercial launch of atacicept, if approved.

Vera Therapeutics announced on July 5, 2024, that it has granted inducement awards under Nasdaq Listing Rule 5635(c)(4) to new employees, including the newly appointed COO, David Johnson. The grants, approved by the Compensation Committee, include non-qualified stock options to purchase 160,000 shares for Johnson and additional inducement awards of 139,100 stock options and 61,925 restricted stock units (RSUs) to ten new employees. The exercise prices for the stock options are $36.29 and $34.93, corresponding to the closing trading prices on the respective grant dates of July 1 and July 2, 2024. The options and RSUs will vest over four years, contingent upon continuous service. These awards are a strategic incentive to attract top talent to Vera Therapeutics.

Vera Therapeutics announced the immediate appointment of David L. Johnson as Chief Operating Officer. Johnson brings over 30 years of experience in the biopharmaceutical industry, including key roles at Global Blood Therapeutics and Gilead Sciences. He will oversee the commercialization efforts for atacicept, a treatment for IgAN, which is currently in Phase 2b and Phase 3 clinical trials. CEO Marshall Fordyce highlighted Johnson's expertise in successful commercial launches as important for the potential launch of atacicept. Johnson expressed enthusiasm for advancing atacicept, noting its promising clinical data and potential to be among the first approved B cell modulators for IgAN.