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Hemostemix Inc
Symbol HEM
Shares Issued 756,811,552
Close 2020-11-27 C$ 0.01
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ORIGINAL: Hemostemix obtains trial data, arranges financing

2020-11-27 16:16 ET - News Release

Received by email:

File: '\\doc\emailin\20201127 130338 Attachment 2020 -  46 Hemostemix In Possession of its Clinical Trial Data and $25
--->00000 Unit Financing - Nov 2020 FINAL.docx'

Hemostemix Announces Possession of All Clinical Trial Data and 
$2,500,000 Unit Financing 

Calgary, Alberta, November 27, 2020- Hemostemix Inc. ("Hemostemix" or the "Company") (TSXV:HEM; OTC: HMTXF) is pleased
---> to announce that (i) Hemostemix has obtained from Medrio, Inc. ("Medrio") a copy of its entire clinical trial databas
--->e that was being hosted by Medrio relating to the HS 12-01 clinical trial for ACP-01 therapy; and (ii) Medrio has deni
--->ed, and will continue to deny, in perpetuity, Aspire Health Science, LLC ("Aspire"), and any of Aspire's employees, of
--->ficers, agents, consultants, or representatives from accessing the Hemostemix's ACP-01 clinical trial database through
---> the Medrio platform. 
"As every biotech investor knows, it is all about the data! Blinded, we will know in short order if our HS 12-01 midpo
--->int results equal the interim clinical trial results that 83% of patients followed for up to 4.5 years experienced hea
--->ling of wounds and cessation of pain; or is similar to the 20 patient randomized PAD study results after two years fol
--->low-up that of the 10 treated with ACP-01: no deaths and 7 of 10 (70%) limbs saved from amputation,  as compared to th
--->e 10 placebo patients: 2 of 10 deaths and 6 of 10 limbs lost to amputation," stated Thomas Smeenk, CEO.  "Fortunately,
---> we have a lot of data of the efficacy of ACP," he continued. "For example, we have the clinical trial results of the 
--->41 patients treated for cardiomyopathy that demonstrated overall ejection fraction improved significantly by 4.8% plus
---> or minus 7.5% at 149 plus or minus 98 days postoperatively, increasing from 25.9% plus or minus 8.6% to 28.7% plus or
---> minus 9.8% in dilated cardiomyopathy, and from 26.6% plus or minus 5.8% to 33.6% plus or minus 7.8% in ischemic cardi
--->omyopathy; and, we have the results of the 106 ischemic heart disease patients on maximal medical therapy who had no o
--->ption for revascularization, who experienced significant improvement in NYHA functional class which improved from 2.69
--->% plus or minus 0.56 to 1.64% plus or minus  0.83 (N=32, p<0.001), and who gained left ventricular ejection fraction (
--->LVEF <40%) at baseline 34.4% plus or minus 16.4% to 39.1% plus or minus  15% (N=39, p<0.05)," Smeenk stated. 
The Hemostemix ACP-01 clinical trial database is the product of its Phase II multi-center randomized double-blind plac
--->ebo-controlled clinical trial of ACP-01 in critical limb ischemia (CLI) patients who have no revascularization options
--->. Study subjects are randomized 2:1 to an injection of ACP-01 or a placebo into their most affected lower limb and fol
--->lowed for at least 26 weeks. The clinical trial is ongoing.

Hemostemix has entered into a contract with a new Clinical Research Organization (CRO) who is completing the midpoint 
--->statistical analyses of the efficacy of ACP-01. On October 21, 2019, Hemostemix announced the abstract and interim res
--->ults presented to the 41st Annual Canadian Society for Vascular Surgery Meeting, which noted healing of ulcers and res
--->olution of ischemic rest pain occurred in 83% of patients studied by lead investigators at the University of British C
--->olumbia and the University of Toronto with outcomes maintained for up to 4.5 years.

As stated in previous news releases, Aspire has no license to manufacture ACP-01, nor any manufacturing rights to Hemo
--->stemix's  technology whatsoever. Aspire had no right to sublicense Hemostemix's technology whatsoever. Any  sublicense
---> would have required the approval of Hemostemix, which has never been granted by Hemostemix. The amended license agree
--->ment previously executed by Hemostemix and Aspire is of no force and is not in effect. 


Hemostemix is pleased to announce a non-brokered private placement of units ("Units") for gross proceeds of up to $2,5
--->00,000 (the "Offering"), subject to TSX Venture Exchange (the "TSXV") approval. The Offering consists of the issuance 
--->of up to an aggregate of 250,000,000 Units at a price of $0.01 per Unit. Each Unit consists of one common share in the
---> capital of the Company ("Common Share") and one Common Share purchase warrant ("Warrant"), with each full Warrant ent
--->itling the holder to acquire one Common Share at a price of $0.05 per Common Share for a period of 12 months from the 
--->closing of the Offering, subject to the accelerated expiry provision described as follows. If on any 10 consecutive tr
--->ading days occurring after four months and one day has elapsed  following  the closing  date of  the Offering, the clo
--->sing price of the Common  Shares  (or the closing  bid, if no sales were reported on a trading day) as quoted on the T
--->SXV is greater than $0.07 per Common Share, Hemostemix may provide notice in writing to the holders of the Warrants by
---> issuance of a news release that the expiry date of the Warrants will be accelerated to the 30th day after the date on
---> which Hemostemix issues such news release. Assuming the completion of the maximum Offering, the proceeds from the Off
--->ering are expected to be used as follows: 8% cash finder fees payable in connection with the Offering; filing fees in 
--->connection with the Offering, legal fees in connection with the litigation against Aspire and other parties;  clinical
---> trial costs accounts payable; and general working capital.  
The Offering will be completed pursuant to certain exemptions from the prospectus requirements under applicable securi
--->ties law including the Accredited Investor Exemption, the Close Friends and Business Associates Exemption, the Investm
--->ent Dealer Exemption, and the Existing Shareholder Exemption described below. The pricing of the Offering is based on 
--->the temporary relief measures established by the TSXV on April   8, 2020, and extended September 16, 2020, in response
---> to the COVID-19 pandemic. The TSXV published the temporary relief  measures to Policy 4.1 and Policy 4.3, lowering th
--->e minimum pricing from $0.05 to $0.01 per share for shares issued pursuant  to a private placement when the market pri
--->ce of an issuer's shares is not greater than $0.05.  It is not anticipated that any new insiders will be created, nor 
--->that any change of control will occur,  as a result of the Offering. Any participation by insiders of the Corporation 
--->in the Offering will be on the same terms as arm's length investors. There is no minimum  subscription amount for the 
--->Offering or minimum Offering, but completion of the Offering is subject to  all regulatory approvals, including the TS
--->XV acceptance. Depending on market conditions,  the gross proceeds of the Offering could be increased or decreased. Al
--->l securities issued in connection with the Offering will be subject to a hold period of four months and one day from t
--->he date of closing. The Offering may be closed in one or more tranches. Closing of the Offering is anticipated to occu
--->r on or around December 15, 2020. The  Company may pay finders fees to eligible finders of up to 8% cash and 8% Finder
---> Warrants. Each Finder's  Warrant may be exercised to acquire a Unit of the Offering at $0.01, which may only be exerc
--->ised following  the 1 new Common Share for each 20 Common Shares Consolidation (described below).    For further  deta
--->ils on the Offering, please contact Hemostemix at the contact information set  forth below.  
Subject to acceptance by Hemostemix, the Offering is open to all existing shareholders of the Company in reliance upon
---> the existing shareholder prospectus exemption described in Alberta Securities Commission rule 45-516 "Prospectus Exem
--->ptions For Retail Investors And Existing Security Holders" and as also set forth in various corresponding blanket orde
--->rs and rules in the applicable provinces and territories of Canada (the "Existing Shareholder Exemption"). The aggrega
--->te acquisition cost to a subscriber under the Existing Shareholder Exemption cannot exceed $15,000 unless that subscri
--->ber has obtained advice from a registered investment dealer regarding the suitability of the investment. The Company h
--->as fixed November 23, 2020 as the record date for the purpose of determining existing shareholders of the Company who 
--->are entitled to participate in the Offering pursuant to the Existing Shareholder Exemption. Subscribers purchasing Uni
--->ts under the Existing Shareholder Exemption will need to represent in writing that they meet certain requirements of t
--->he Existing Shareholder Exemption, including that on or before the record date, they became a shareholder of the Compa
--->ny and that they continue to be a shareholder of the Company. In accordance with the requirements of the Existing Shar
--->eholder Exemption and the Investment Dealer  Exemption described in ASC Rule 45-516, the Company confirms there is no 
--->material fact or material change related to the Company which has not been generally disclosed.  


On June 29, 2020, Hemostemix filed an action in Delaware federal court against Accudata Solutions, Inc. ("Accudata")  
--->for failing to provide a statistical analysis of Hemostemix's clinical trial data and for failing to return  the clini
--->cal trial data upon demand.  Hemostemix also filed an injunction application to compel  Accudata to provide the statis
--->tical analysis and clinical trial data to Hemostemix pursuant to  Accudata's contractual obligations.  

Aspire Health Science, LLC ("Aspire")  moved to intervene in this action and filed an answer to the original complaint
--->. Oral argument on Hemostemix's preliminary injunction application  against Accudata was conducted on July 15, 2020, a
--->nd Hemostemix is awaiting a decision on that injunction application.  

In addition, Hemostemix was granted leave to file an amended complaint to include claims against Aspire and  did so on
---> July 27, 2020.  Aspire filed a Motion to Dismiss Hemostemix's amended complaint on August 14, 2020 and Hemostemix fil
--->ed a response to Aspire's Motion to Dismiss on August   28, 2020. Accudata filed a Motion to Dismiss Hemostemix's amen
--->ded complaint on August 24, 2020,  and Hemostemix filed a response to Accudata's Motion to Dismiss on September  8, 20
--->20.   Briefing is completed and the parties await the Court's ruling on both Motions to Dismiss. 

On January 28, 2020, Aspire filed an action against Hemostemix in Florida state court for declaratory relief and speci
--->fic performance to enforce the amended licensing agreement among Aspire and Hemostemix which Hemostemix properly resci
--->nded on December 5, 2019 for Aspire's default. Hemostemix filed a Motion to Dismiss the Florida action on the basis of
---> lack of personal jurisdiction, to challenge service of the complaint, and to challenge the sufficiency of the pleadin
--->g. Aspire also brought a Motion for a "Speedy Hearing".
Argument was heard on Hemostemix's Motion to Dismiss on June 25, 2020.  On September 30, 2020, the Court denied Hemost
--->emix's Motion to Dismiss but quashed service after finding Aspire had failed to comply with international law and perf
--->ect service of process on Hemostemix.  Hemostemix has appealed to the Florida intermediate court of appeals that porti
--->on of the order denying its Motion to Dismiss, filing an appeal brief on October 19, 2020.  Aspire filed its oppositio
--->n to the appeal on November 25, 2020.  Aspire has failed, to date, to perfect service of process on Hemostemix in Cana
--->da.  Given the jurisdictional and venue challenge raised on appeal, Hemostemix has moved to stay the underlying procee
--->ding pending a ruling on appeal. 

Further to the approval of the 20 for 1 Common Share consolidation (the "Consolidation") that was approved at the annu
--->al general and special meeting of shareholders of Hemostemix held on May 6, 2020 , Hemostemix  intends to implement th
--->e Consolidation prior to December 31, 2020. Hemostemix will provide further information in  respect of the Consolidati
--->on in future news releases when the board of directors of Hemostemix has made a decision in  respect of the effective 
--->date of the Consolidation. 

Hemostemix is a publicly traded autologous stem cell therapy company. A winner of the World Economic Forum Technology 
--->Pioneer Award, Hemostemix developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angi
--->na, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat ov
--->er 500 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and effic
--->acy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from ampu

On October 21, 2019, Hemostemix announced the abstract and interim results presented to the 41st Annual Canadian Socie
--->ty for Vascular Surgery Meeting titled "Autologous Stem Cell Treatment for CLI Patients with No Revascularization Opti
--->ons: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Follow-up" which noted healing of ulcers and resolution of
---> ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.  
Hemostemix 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. For more information, pleas
--->e visit www.hemostemix.com. 
Contact: Thomas Smeenk, President, CEO & Co-Founder
TSmeenk@Hemostemix.com   905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of th
--->e TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable
---> Canadian securities legislation. All statements, other than statements of historical fact, included herein are forwar
--->d-looking information. In particular, this news release contains forward-looking information in relation to: the compl
--->etion of a midpoint statistical analysis; the Offering including the size of the Offering, the use of proceeds of the 
--->Offering, the closing date for the Offering, the potential exemptions used for the Offering, any potential finder's fe
--->e paid on the Offering,  and the potential accelerated expiry date of the Warrants ; the status of Hemostemix's Litiga
--->tion (as defined below), including decisions on such Litigation; further information to be provided in  respect of the
---> Consolidation, including the date by which Hemostemix intends to implement the Consolidation; and the commercializati
--->on of ACP-01.   There can be no assurance that such forward-looking information will prove to be accurate. Actual resu
--->lts and future events could differ materially from those anticipated in such forward-looking information. This forward
--->-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostem
--->ix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the under
--->lying value of Hemostemix and its Common Shares; market acceptance  of the Offering; TSXV acceptance of the Offering; 
--->the successful resolution of the litigation that Hemostemix is pursuing or defending (the "Litigation"); the results o
--->f ACP-01 research, trials studies and analysis, including the midpoint analysis, being equivalent to or better than pr
--->evious research, trials or studies as well as management's  expectations of anticipated results; Hemostemix's general 
--->and administrative costs remaining constant; the receipt of all required regulatory  approvals for research, trials or
---> studies; the level of activity, market acceptance and market trends in the healthcare sector; the  economy generally;
---> consumer  interest in Hemostemix's services and products; competition and  Hemostemix's competitive advantages; and H
--->emostemix obtaining satisfactory financing to  fund Hemostemix's operations including any research, trials or studies,
---> and the Litigation. Forward-looking information is subject to known and unknown risks, uncertainties and other factor
--->s that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially dif
--->ferent from those expressed or implied by such forward-looking information. Such risks and other factors may include, 
--->but are not limited to: the ability of Hemostemix to complete its current CLI clinical trial, complete a satisfactory 
--->futility analysis and the results of such and future clinical  trials;  litigation and potential litigation that Hemos
--->temix may face; general business, economic, competitive, political and social uncertainties; general capital market co
--->nditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual resul
--->ts of future operations including the actual results of future research, trials or studies; competition; changes in le
--->gislation  affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capi
--->tal requirements and future developments in Hemostemix's markets and the markets in which it expects to compete;  lack
---> of qualified, skilled labour or loss of key individuals; and risks  related to the COVID-19 pandemic including variou
--->s recommendations, orders and measures of governmental authorities to  try to limit the pandemic, including travel res
--->trictions, border closures, non-essential business closures,  service disruptions, quarantines, self-isolations, shelt
--->ers-in-place and social distancing, disruptions to markets, disruptions to economic activity and   financings, disrupt
--->ions to supply chains and sales channels, and a deterioration of general economic conditions including a  possible nat
--->ional or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix may in
--->clude a decreased demand for the services that Hemostemix  offers; and a deterioration of financial markets that could
---> limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actu
--->al results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on 
--->the SEDAR website at www.sedar.com. Although Hemostemix has attempted to identify important factors that could cause a
--->ctual results to differ materially from those contained in forward-looking information, there may be other factors tha
--->t cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of fact
--->ors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as the
--->re can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looki
--->ng information contained in this news release is expressly qualified by this cautionary statement. The forward-looking
---> information contained in this news release represents the expectations of Hemostemix as of the date of this news rele
--->ase and, accordingly, it is subject to change after such date. However, Hemostemix expressly disclaims any intention o
--->r obligation to update or revise any forward-looking information, whether as a result of new information, future event
--->s or otherwise, except as expressly required by applicable securities law.

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