Hemostemix Secures Full LARTA Approval for Its VesCell Study in The Bahamas

Hemostemix Secures Full LARTA Approval for Its VesCell Study in The Bahamas

C$0.05 a unit. That is the price Hemostemix set for new investors on October 7, in the same release that announced full approval to run its lead cell therapy study in The Bahamas. Further down that release, the company disclosed that a manufacturing license deal it first announced in February 2025 will not go ahead.

Hemostemix Secures Full LARTA Approval for VesCell Phase 1 Study

Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) announced on October 7 that it has received full approval from the National Longevity and Regenerative Therapy Board of The Bahamas, known as the LARTA Board after the country’s Longevity and Regenerative Therapy Act. Ethics approval from the board’s ethics committee is included. The approval covers what the company calls a commercial Phase 1 study of VesCell as a treatment for angina, vascular dementia and pain.

VesCell, which the company also refers to as ACP-01, is an investigational autologous cell therapy, meaning it is made from the patient’s own blood. A Phase 1 study is the earliest stage of human testing and is built mainly to assess safety.

In August the approval was still pending. On August 20, Hemostemix described its vascular dementia trial as having enrollment underway, while noting the trial remained subject to final approvals in progress under LARTA. The October 7 release calls the new approval full, with ethics approval included.

The release does not disclose the study’s planned enrollment or its design. It also says nothing about what, if anything, participants pay.

LARTA Approval Is Not FDA or Health Canada Approval

The word “commercial” in the release does not mean VesCell can be sold in North America. Hemostemix stated in its August release that VesCell has not been approved by the U.S. Food and Drug Administration or Health Canada for vascular cognitive impairment or vascular dementia. A Bahamian authorization to run a study leaves that status unchanged.

Hemostemix says it has completed seven clinical studies of 318 subjects over its history. Those figures come from the company’s own boilerplate. No new efficacy data appears in the October 7 release.

A second filing is in preparation. Hemostemix plans another protocol that would study VesCell for longevity, with cognition and heart function among its measures; heart function would be tracked through left ventricular ejection fraction (LVEF), the share of blood the heart’s main pumping chamber pushes out with each beat. Inflammatory biomarkers tied to immune health are also on the list. No filing date has been given.

Hemostemix Prices New Units at C$0.05 in Raise of Up to $1 Million

Hemostemix has filed a Form 4B with the TSX Venture Exchange seeking price protection, a filing used to reserve the offering price, for a non-brokered private placement, meaning units sold directly to investors without an investment dealer, of up to $1,000,000. It is completing an initial closing of C$380,500 through the issuance of 7,610,000 units at C$0.05 each.

Each unit is one common share plus one-half of a warrant, and each whole warrant buys an additional share at C$0.12 for 24 months. An acceleration clause applies. Once four months and one day have passed after closing, if the volume-weighted average price holds at or above C$0.15 for 10 consecutive trading days, Hemostemix can shorten the warrants’ remaining life to 30 days after announcing it.

The initial closing alone means 7,610,000 new shares, plus warrants for 3,805,000 more. If the full $1,000,000 is raised at the same price, the arithmetic works out to 20,000,000 new shares and 10,000,000 warrants. The company has not said the full amount will be raised. Its U.S. line trades on the OTCQB, a mid-tier U.S. over-the-counter market that requires companies to stay current in their reporting.

Proceeds are intended for ACP-01 manufacturing, clinical-program preparation, regulatory submissions, physician education and general working capital. Final TSXV acceptance is still outstanding.

This is not the first raise at five cents. The October 7 release describes the new offering as in addition to the placement disclosed on June 17, 2026, which it says raised total proceeds of $682,250. The June 17 release used the same C$0.05 unit price and C$0.12 warrant strike, so at that price $682,250 works out to 13,645,000 shares. That earlier release said certain directors may participate. The October 7 release does not identify any insider participation in the new closing, and no specific cash runway was identified in the company releases reviewed.

Hemostemix Drops the CytoImmune Bioreactor License Deal

Hemostemix will not proceed with the proposed CytoImmune bioreactor technology license it announced on February 19, 2025. The transaction never closed. The 20 million common shares contemplated as consideration were not issued.

CytoImmune remains part of the manufacturing picture. It has completed ACP-01 test batches outside a cleanroom, a controlled low-contamination space used for clinical cell manufacturing, and test-batch production moves into the cleanroom next. Hemostemix describes that move as the next step in manufacturing process development. No date was given.

Hemostemix Restated Its Q3 2025 Financials in June

The October 7 release lists among its risks that “the restatement process and adjustments may change.” That refers to a June 17, 2026 filing in which Hemostemix restated its unaudited interim statements for the nine months ended September 30, 2025, after determining it had misaccounted for convertible debentures issued July 14, 2025.

The restated debenture liability came to $3.5 million, against $3.4 million as originally reported. Hemostemix said most adjustments were non-cash and that its cash position was not affected. The original Q3 2025 statements, filed November 28, 2025, should no longer be relied upon, per the company.

None of the October 7 news addresses the restatement beyond that risk line.

Hemostemix Next Steps: TSXV Acceptance and Cleanroom ACP-01 Batches

The C$0.05 placement remains subject to final TSX Venture Exchange acceptance, and Hemostemix has not dated any closing beyond the initial C$380,500. Warrants from the placement cannot be accelerated until four months and one day after the applicable closing date. Moving ACP-01 test-batch production into the cleanroom is the next disclosed manufacturing step, with no date attached. The second LARTA protocol, for longevity, is in preparation and has not been filed.

Sources

Editorial Disclosure

This article is based on Hemostemix Inc. press releases distributed via TMX Newsfile and dated October 7, August 20 and June 17, 2026. The security discussed is Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0). aktiego.com has not received any compensation from Hemostemix, its management, investor relations representatives, or any third party. No staff member or principal of aktiego.com holds a position in this security at the time of publication.

The approval described is granted by the National Longevity and Regenerative Therapy Board of The Bahamas. It is not an approval, clearance or authorization from the U.S. Food and Drug Administration or Health Canada. VesCell (ACP-01) is investigational and is not approved by either regulator for any indication. “Commercial” is the company’s own description of the study; planned enrollment, design and any participant fees were not disclosed in the releases reviewed. The figure of seven clinical studies and 318 subjects is company-stated and has not been independently verified by aktiego.com.

The C$0.05 unit offering is dilutive to existing shareholders. The initial closing involves 7,610,000 shares and warrants for 3,805,000 more, exercisable at C$0.12; at the full $1,000,000, the same terms imply 20,000,000 shares and 10,000,000 warrants. The offering remains subject to final TSX Venture Exchange acceptance, and there is no assurance it closes in full. The June 17, 2026 release stated that certain directors may participate in the earlier placement on the same terms; no insider participation is identified for the October closing. No specific cash runway or going-concern disclosure was identified in the company releases reviewed.

The proposed CytoImmune bioreactor technology license announced February 19, 2025 did not close and will not proceed. ACP-01 test-batch production has not yet moved into a cleanroom, and no timeline for that step has been disclosed. The planned longevity protocol has not been filed. All such statements are company forward-looking information and are not guaranteed.

In June 2026, Hemostemix restated its interim financial statements for the nine months ended September 30, 2025, and stated that the originally filed versions should no longer be relied upon. Its October 7, 2026 release continues to cite the risk that the restatement process and adjustments may change. The LARTA approval and financing are separate developments and do not resolve that risk. Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of Hemostemix’s releases, per the company’s own standard disclosure.

Small cap and micro-cap stocks listed on the CSE, TSX, TSXV, and Nasdaq are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.

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