Hemostemix basket protocol pre-IND meeting set for Jan.

Executive Summary

• Hemostemix Inc. announced that the U.S. FDA has scheduled a pre-IND meeting for January 16, 2026, to review its basket clinical trial protocol for ACP-01 targeting various ischemic conditions.
• The company announced a non-brokered private placement of up to $960,000, consisting of 8 million common shares at $0.12 per share, subject to TSX Venture Exchange approval.
• Proceeds from the financing will be used for FDA regulatory preparations, clinical operations expansion in Florida, the Bahamas, and Canada, and general corporate working capital.

Key Details

• FDA Pre-IND Meeting: Scheduled for January 16, 2026.
• Protocol Scope: The basket protocol unifies treatment for vascular dementia, ischemic cardiomyopathy, peripheral arterial disease, and generalized ischemia under a single ischemia-based mechanism of action for ACP-01.
• Financing Structure: Non-brokered private placement of up to $960,000.
• Share Issuance: 8 million common shares issued at a price of $0.12 per share.
• Warrant Terms: No warrants attached to the shares.
• Hold Period: All securities are subject to a four-month hold period per applicable securities laws and TSX Venture Exchange policies.
• Regulatory Status: Financing is subject to final TSX-V approval.
• Use of Proceeds:
  • FDA regulatory preparations and meeting execution.
  • Clinical operations expansion in Florida, the Bahamas, and Canada.
  • General corporate working capital.
• Company Background: Hemostemix is an autologous stem cell therapy platform company founded in 2003, with 7 completed clinical studies involving 318 subjects and 11 peer-reviewed publications.

Notable Quotes

• "The FDA pre-IND meeting brings us closer to a unified ischemia-based clinical trial program," stated Thomas Smeenk, CEO. "It makes sense to address ischemia in multiple indications, given our success rate in these conditions as published in 11 peer-reviewed articles. Why a phase 1 clinical trial? First, lantrida, an allogenic stem cell treatment, was approved on phase 1 only data. That is a precedent. Second, we can charge patients to be studied (treated) and followed. Third, we can publish the interim results and end points, comparing improvements in cognition (vascular dementia), LVEF percentage (ICM), wound healing (PAD), reduction of pain (general ischemia, ICM plus PAD) and improvement of quality of life (all indications) for all participants. Plus, it generates a protocol for all patients who are treated, who do not meet inclusion criteria. Thus we study every patient treated with ACP-01 to generate the scientific basis for its approval," Mr. Smeenk said.