Core Points - Hemostemix Inc. has announced a Pre-IND meeting with the FDA scheduled for January 16, 2026, to discuss its basket clinical trial protocol for ACP-01, aimed at treating various ischemic conditions [2][6] - The company is also conducting a non-brokered private placement to raise up to $960,000 through the issuance of 8,000,000 common shares at a price of $0.12 per share [3][6] FDA Pre-IND Meeting - The FDA meeting will focus on a unified ischemia-based mechanism of action for ACP-01, which targets multiple ischemic conditions [2][6] - Hemostemix plans to present its clinical rationale, manufacturing platform, and regulatory pathway to advance towards FDA clearance for its Phase I clinical trial [2][6] Non-Brokered Private Placement - The private placement aims to raise $960,000, with all securities subject to a four-month hold period [3][6] - The financing is pending final approval from the TSX Venture Exchange [3][6] CEO Comments - The CEO emphasized the significance of the FDA meeting in advancing a unified clinical trial program for ischemia [4][6] - The company has a precedent for Phase I clinical trials, citing the approval of Lantrida based on similar data [4][6] Use of Proceeds - Proceeds from the private placement will be utilized to advance FDA regulatory preparations, clinical operations expansion in Florida, The Bahamas, and Canada, and general corporate working capital [10]
Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of $960,000
Newsfile·2025-12-10 16:17