Kezar Life Sciences, Inc. - KZR STOCK NEWS

Kezar Life Sciences (Nasdaq: KZR) announced a 1-for-10 reverse stock split effective October 29, 2024, at 5:00 p.m. Eastern Time. The company's stock will begin trading on a post-split basis on October 30, 2024. This move aims to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share. The split will reduce outstanding shares from 72,962,220 to 7,296,222. Stockholders' positions will be automatically adjusted, with fractional shares rounded up to the nearest whole number. The split was approved by stockholders on June 18, 2024, with the final ratio approved by the Board on September 23, 2024.

Kezar Life Sciences (Nasdaq: KZR) has unanimously rejected an unsolicited proposal from Concentra Biosciences to acquire all outstanding shares for $1.10 per share plus a contingent value right. The Board concluded that the offer substantially undervalues the company and fails to reflect the potential of zetomipzomib. In response to Concentra's rapid accumulation of 9.9% of Kezar's stock, the Board has adopted a duration stockholder rights plan.

The Rights Plan aims to protect stockholders' long-term value and reduce the likelihood of control gain through open market accumulation without paying an appropriate premium. It allows one preferred share purchase right for each outstanding common share as of October 28, 2024. Rights become exercisable if an entity acquires 10% or more of Kezar's stock (15% for passive institutional investors). The plan expires on October 17, 2025, unless redeemed or exchanged earlier.

Kezar Life Sciences (Nasdaq: KZR) announced key clinical development updates for its zetomipzomib trials. The PORTOLA Phase 2a trial in autoimmune hepatitis (AIH) will continue without modification following a positive safety review by the Independent Data Monitoring Committee (IDMC). Topline data is expected in the first half of 2025. However, the company has decided to discontinue the PALIZADE Phase 2b trial in lupus nephritis (LN) patients after it was placed on clinical hold due to four Grade 5 (fatal) serious adverse events. Kezar will now focus its resources on developing zetomipzomib for AIH. The company's unaudited cash position is approximately $148 million as of September 30, 2024.

Kezar Life Sciences (Nasdaq: KZR) has received an unsolicited, non-binding acquisition proposal from Concentra Biosciences, The offer includes:

• Cash consideration of $1.10 per share
• A contingent value right for 80% of net proceeds from any out-license or disposition of Kezar's development programs or intellectual property

Tang Capital Management, , the controlling stockholder of Concentra, owns approximately 9.9% of Kezar's outstanding common stock. Kezar's Board and management team will evaluate the proposal to determine the best course of action for the company and its stockholders. No immediate action is required from Kezar stockholders.

Kezar Life Sciences (Nasdaq: KZR) announced that the FDA has placed a clinical hold on the zetomipzomib Investigational New Drug (IND) application for the treatment of lupus nephritis (LN). This follows Kezar's voluntary suspension of enrollment and dosing in its Phase 2b PALIZADE clinical trial of zetomipzomib in LN patients, based on the recommendation of the trial's Independent Data Monitoring Committee (IDMC).

The IDMC's recommendation came after reviewing emerging safety data, including four Grade 5 (fatal) serious adverse events (SAEs) in patients enrolled in the Philippines and Argentina. The FDA will provide an official clinical hold letter within 30 days. Kezar's CEO, Chris Kirk, emphasized their commitment to patient safety and ongoing investigation of these cases.

The zetomipzomib IND for autoimmune hepatitis remains unaffected, with the Phase 2a PORTOLA clinical trial continuing without any Grade 4 or 5 SAEs observed to date.

Kezar Life Sciences (Nasdaq: KZR) has voluntarily ceased enrollment and dosing in its Phase 2b PALIZADE trial of zetomipzomib for active lupus nephritis. This decision follows the recommendation of the Independent Data Monitoring Committee after reviewing emerging safety data, including four Grade 5 (fatal) serious adverse events in patients from the Philippines and Argentina. Three fatalities showed a common pattern of symptoms and proximity to dosing. Kezar remains blinded to which patients were on zetomipzomib or placebo.

The ongoing Phase 2a PORTOLA trial for autoimmune hepatitis continues, with no Grade 4 or 5 SAEs observed. Kezar is evaluating the data to determine next steps and potential risk mitigation strategies. The company has notified study investigators and is informing regulatory authorities. No formal FDA clinical hold has been issued yet.

Kezar Life Sciences (Nasdaq: KZR), a clinical-stage biotech firm focusing on novel small molecule therapeutics for immune-mediated diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 11, 2024, at 12:00 pm ET in New York, NY.

Chris Kirk, Co-founder and CEO of Kezar, will deliver a corporate overview during the presentation. Investors and interested parties can access a live webcast of the presentation through the "Events & Presentations" section on Kezar's official website. An archived version of the webcast will remain available on the site for 90 days following the event, providing extended access to the company's latest updates and strategic outlook.

Kezar Life Sciences (Nasdaq: KZR) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Completed enrollment in PORTOLA Phase 2a trial of zetomipzomib for autoimmune hepatitis; topline data expected in H1 2025.

2. PALIZADE Phase 2b trial of zetomipzomib for lupus nephritis ongoing; topline data expected mid-2026.

3. Stopped enrollment in KZR-261 Phase 1 study for solid tumors; focusing resources on zetomipzomib programs.

4. Cash, cash equivalents, and marketable securities totaled $164.2 million as of June 30, 2024.

5. Q2 2024 net loss of $21.5 million ($0.30 per share) compared to $24.3 million ($0.34 per share) in Q2 2023.

6. R&D expenses decreased to $16.3 million from $21.0 million in Q2 2023.

Kezar Life Sciences (Nasdaq: KZR) has announced the granting of a nonqualified stock option to a new employee as an inducement award under Nasdaq Listing Rule 5635(c)(4). The option allows the purchase of 72,000 shares at $0.55 per share, matching the closing price on July 8, 2024. The award aims to attract the individual to join Kezar. The stock options will vest over four years: 25% on the first anniversary of the employee’s start date, and 1/48th monthly thereafter, conditional on continued employment. The grant is governed by Kezar’s 2022 Inducement Plan and specific stock option agreement.