BrainStorm plans Phase 3b NurOwn trial, SPA submission in Feb 2024 after ADCOM setback

BRAINSTORM CELL THERAPEUTICS INC.

CEO Chaim Lebovits letter outlines Phase 3b trial as most expedient path to FDA approval for NurOwn ALS therapy.
Company expects to submit clinical protocol, SAP, and SPA request to FDA in February 2024; FDA response within 45 days.
Type A meeting held Dec 6, 2023; FDA engaged and recognized unmet need in ALS, says BrainStorm.
Funding strategies being explored; company aims to boost stock price by April to maintain NASDAQ listing, preferring organic support over reverse split.
Dr. Menghisteab Bairu appointed to Audit Committee replacing Dr. June S. Almenoff, effective Dec 18, 2023.

Key facts

Extracted from this filing and checked against the source text.

Shareholder Votes SEC 8-K Item 5.07 confidence 0.9

BRAINSTORM CELL THERAPEUTICS INC. shareholders approved Election of six nominees to the Board of Directors at the 2023-12-18 meeting.

Proposal: director election
Outcome: passed
Meeting: 2023-12-18

Exact text from the filing

The six nominees (listed below) for election to the Company’s Board of Directors (the “Board”) were elected to hold office until the next annual meeting of stockholders and until their successors are duly elected and qualified or until their earlier resignation or removal, based upon the following votes:

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Shareholder Votes SEC 8-K Item 5.07 confidence 0.9

BRAINSTORM CELL THERAPEUTICS INC. shareholders approved Ratify the appointment of Brightman Almagor Zohar & Co., a Firm in the Deloitte Global Network, as the independent registered public accounting firm for fiscal year ending December 31, 2024 at the 2023-12-18 meeting.

Proposal: auditor ratification
Outcome: passed
Meeting: 2023-12-18

Exact text from the filing

The proposal to ratify the appointment of Brightman Almagor Zohar & Co., a Firm in the Deloitte Global Network, as the Company’s independent registered public accounting firm for the Company’s fiscal year ending December 31, 2024 was approved, based upon the following votes:

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211 shareholder votes filed in the last 30 days. Browse all shareholder votes →

BRAINSTORM CELL THERAPEUTICS INC. filing history →

Source: SEC EDGAR

accession 0001104659-23-127772

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