Mr. Thomas Smeenk reports
HEMOSTEMIX PROVIDES UPDATE OF PHASE II CLINICAL TRIAL, 9TH CIRCUIT COURT DECISION INCLUDING COST AWARD AND ITS ANNUAL GENERAL MEETING RESULTS
Hemostemix Inc. has provided an update on the phase II clinical trial, an update of a decision including a cost award from the Ninth Judicial Circuit Court of Orange county, Florida, and the annual general meeting (AGM) results.
Hemostemix is continuing to complete the groundwork necessary to derive its phase II clinical trial analyses. The process to rescue the trial has taken longer and with increased costs, due largely to Aspire's intransigence of not returning Hemostemix's intellectual property, including, but not limited to, the phase II clinical trial data and related batch information. Aspire's continuous breach of the terms of the February, 2018, licence agreement has forced Hemostemix to seek the data from the clinical trial sites, and complete the work of source document verification and database cleanup, which is work that should have been completed by Aspire during its management of the clinical trial. As noted, Hemostemix is pleased to report that the source document verification process and database cleanup is proceeding. Currently, 39 per cent of source documents are verified. Hemostemix will continue to complete the groundwork necessary to close out the trial, and it will keep shareholders informed of its progress.
On June 28, 2021, the Ninth Judicial Circuit Court of Orange county, Florida, denied Aspire's motion to compel production of documents from Hemostemix. The court sustained Hemostemix's objections as to relevancy and scope of the categories of documents Aspire sought, and the court awarded Hemostemix its fees and costs incurred in defending against Aspire's motion. Hemostemix is preparing a fee petition that quantifies the fees and costs incurred for the court's consideration.
The following are the summarized results of the motions voted upon at the AGM held on May 31, 2021:
- Financial statements -- It was unanimously decided that the audited consolidated financial statements of the company for the years ended Dec. 31, 2019, and Dec. 31, 2020, the auditor's report thereon, and the related management's discussion and analysis as presented were accepted and included as part of the formal record of the AGM.
- Size of the board of directors (four members) -- The motion was duly carried by 99 per cent of shareholders recorded in attendance.
- Election of each director -- Dr. Ronnie Hershman (72 per cent), Loran Swanberg (73 per cent), Thomas Smeenk (72 per cent) and Peter Lacey (99 per cent) were independently elected by shareholders recorded in attendance.
- Appointment of auditor, MNP Canada LLP, Chartered Accountants -- The motion was duly carried by 99 per cent of shareholders recorded in attendance.
- Approval of stock plan -- The motion was duly carried by 99 per cent of shareholders recorded in attendance.
About Hemostemix Inc.
Hemostemix is a publicly traded autologous stem cell therapy company. A winner of the World Economic Forum Technology Pioneer Award, the company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, angina, ischemic cardiomyopathy, dilated cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 500 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia, who have exhausted all other options to save their limb from amputation.
On Oct. 21, 2019, the company announced the results from its phase II CLI trial abstract, entitled "Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup," which noted healing of ulcers and resolution of ischemic rest pain occurred in 83 per cent of patients, with outcomes maintained for up to 4.5 years.
The company owns 91 patents across five patent families titled: regulating stem cells, in vitro techniques for use with stem cells, production from blood of cells of neural lineage and automated cell therapy.
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