Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of $960,000

Executive Summary

• Hemostemix Inc. received notice that the U.S. FDA has scheduled a Pre‑IND meeting for its basket protocol on January 16, 2026 to discuss a Phase I trial of ACP‑01 across multiple ischemia‑related indications.
• The company announced a non‑brokered private placement of up to $960,000, consisting of 8,000,000 common shares at $0.12 per share (no warrants), subject to TSXV approval and a four‑month hold period.
• Proceeds from the financing will be used for FDA regulatory preparation, expansion of clinical operations in Florida, The Bahamas and Canada, and general corporate working capital.

Key Details

• FDA Pre‑IND Meeting
• Date scheduled: January 16, 2026.
• Agenda: Review basket protocol covering vascular dementia, ischemic cardiomyopathy, peripheral arterial disease (PAD), and generalized ischemia.

• Goal: Advance toward FDA clearance of a Phase I basket clinical trial for ACP‑01.

• Non‑Brokered Private Placement

• Total amount: Up to $960,000.
• Shares offered: 8,000,000 common shares.
• Price per share: $0.12.
• No accompanying warrants.
• Securities subject to a four‑month hold period under TSXV policies and applicable securities laws.

• Financing contingent on final TSXV approval.

• Use of Proceeds

• FDA regulatory preparations and execution of the Pre‑IND meeting.
• Expansion of clinical operations in Florida, The Bahamas, and Canada.

• General corporate working capital.

• CEO Comment (Thomas Smeenk)

• Highlighted the significance of the FDA Pre‑IND meeting for a unified ischemia‑based trial program.
• Emphasized precedent of Phase I approval for similar stem‑cell therapies and the ability to generate scientific data across multiple indications.

Notable Quotes

“The FDA Pre‑IND meeting brings us closer to a unified ischemia‑based clinical trial program,” said CEO Thomas Smeenk. “It makes sense to address ischemia in multiple indications, given our success rate in these conditions as published in 11 peer‑reviewed articles.”

Materiality Assessment: Material – Positive (the FDA meeting schedule and financing are material corporate developments that positively impact the company’s near‑term prospects).