Hemostemix Inc. (TSXV: HEM; OTCQB: HMTXF; FSE: 2VF0) has received regulatory and ethics approval in The Bahamas for a commercial Phase 1 study of its investigational VesCell cell therapy.
The company announced on October 7 that the National Longevity and Regenerative Therapy Board, known as the LARTA Board, granted full approval for the study. The basket protocol will evaluate VesCell in patients with angina, vascular dementia and pain.
VesCell, also known as ACP-01, is an autologous cell therapy manufactured using cells collected from a patient’s own blood. Hemostemix is developing the treatment to support the formation of new blood vessels and improve circulation in areas affected by ischemic disease.
The company’s use of the term “commercial Phase 1” refers to a clinical-research model operating under Bahamian legislation. The authorization is not FDA or Health Canada approval, and it does not establish that VesCell is safe or effective. Hemostemix has not yet disclosed the study’s planned enrollment, treatment schedule, primary endpoints or first-patient-treatment date.
Manufacturing work is also continuing. CytoImmune has completed ACP-01 test batches outside its cleanroom and plans to move test-batch production into the cleanroom during the next stage of process development. Hemostemix said it will not proceed with a previously proposed CytoImmune bioreactor technology license, meaning the contemplated issuance of 20 million common shares will not occur.
Financing remains important to the program. Hemostemix is completing an initial C$380,500 closing through the issuance of 7.61 million units at C$0.05 each as part of a proposed financing of up to C$1 million. Each unit contains one common share and one-half warrant, with each whole warrant exercisable at C$0.12 for 24 months.
The company intends to use the proceeds for manufacturing, clinical preparation, regulatory submissions, physician education and working capital. The shares and warrants introduce additional dilution for existing investors.
Hemostemix reported C$139,203 in cash and C$257,043 in total current assets as of June 30, 2026, compared with approximately C$1.97 million in current liabilities. It generated no revenue, recorded a six-month net loss of approximately C$1.46 million and used approximately C$1.20 million in operating cash.
The filing identified significant doubt about the company’s ability to continue as a going concern. Financings completed after the reporting date improve near-term liquidity but do not eliminate the company’s need for additional capital.
“The Centurion One meeting in Nassau gives us an opportunity to introduce investors to the hospital where, and the physicians who, are partnering with Hemostemix,” CEO Thomas Smeenk said ahead of an October 19–21 conference in The Bahamas.
Upcoming Catalysts
- Disclosure of the VesCell study design and enrollment target
- First patient enrollment and treatment in The Bahamas
- Cleanroom manufacturing of ACP-01 test batches
- Additional closings under the proposed C$1 million financing
- Filing of a separate VesCell longevity-study protocol
- Updates from the October 19–21 Bahamas investor conference
Sources
- Hemostemix Announces Full LARTA Approval, Manufacturing Progress and Financing Update — Newsfile, October 7, 2026
- Hemostemix Interim Financial Statements for the Six Months Ended June 30, 2026
- Hemostemix Files Bahamas Commercialization Application — Newsfile, July 8, 2026
- Hemostemix Announces Participation in Bahamas Summit — Newsfile, September 28, 2026
Editorial Disclosure
This article is based entirely on publicly available information, including company announcements and securities filings. Securities discussed or referenced include Hemostemix Inc. (TSXV: HEM; OTCQB: HMTXF; FSE: 2VF0). Biotech Stocks Daily has not received compensation from Hemostemix, its management, investor relations representatives or any third party for this specific article. Biotech Stocks Daily may have current or past paid business relationships with other companies, which do not influence the content or conclusions of this article. No staff member or principal of Biotech Stocks Daily holds a position in any security mentioned at the time of publication.
Sources used include Hemostemix’s October 7, 2026 LARTA, manufacturing and financing announcement; its July 8, 2026 commercialization-application announcement; its September 28, 2026 Bahamas conference announcement; and its unaudited interim financial statements for the six months ended June 30, 2026. Information concerning VesCell’s mechanism, development potential, manufacturing and proposed commercialization originated primarily from Hemostemix and has not been independently validated by Biotech Stocks Daily.
VesCell remains investigational. Approval from the Bahamian LARTA Board and ethics committee does not constitute approval from the U.S. Food and Drug Administration, Health Canada or another jurisdiction. The authorization does not establish safety or efficacy, and the study may encounter manufacturing, enrollment, safety, regulatory or operational delays. Hemostemix has not disclosed the planned enrollment, endpoints or first-patient-treatment date.
Financial information is reported in Canadian dollars and reflects Hemostemix’s position as of June 30, 2026 unless otherwise stated. The company reported no revenue, continuing operating losses, negative operating cash flow and significant doubt regarding its ability to continue as a going concern. Its private placements involve common shares and warrants that dilute existing shareholders and may create additional dilution if the warrants are exercised.
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