0001085037-23-000107.txt : 20230914 0001085037-23-000107.hdr.sgml : 20230914 20230913173244 ACCESSION NUMBER: 0001085037-23-000107 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20230913 FILED AS OF DATE: 20230914 DATE AS OF CHANGE: 20230913 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLICEL LIFE SCIENCES INC. CENTRAL INDEX KEY: 0001205059 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50112 FILM NUMBER: 231253596 BUSINESS ADDRESS: STREET 1: SUITE 900 - 570 GRANVILLE STREET CITY: VANCOUVER BC STATE: A1 ZIP: V6C 3P1 BUSINESS PHONE: 604-248-8693 MAIL ADDRESS: STREET 1: SUITE 900 - 570 GRANVILLE STREET CITY: VANCOUVER BC STATE: A1 ZIP: V6C 3P1 FORMER COMPANY: FORMER CONFORMED NAME: NEWCASTLE RESOURCES LTD. DATE OF NAME CHANGE: 20081128 FORMER COMPANY: FORMER CONFORMED NAME: PAN AMERICAN GOLD CORP DATE OF NAME CHANGE: 20040521 FORMER COMPANY: FORMER CONFORMED NAME: TRI LATERAL VENTURE CORP DATE OF NAME CHANGE: 20021109 6-K 1 f6k091323.htm FORM 6-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2023
Commission File Number 000-50112
RepliCel Life Sciences Inc.
(Translation of registrant’s name into English)
Suite 900 – 570 Granville Street, Vancouver, British Columbia  V6C 3P1
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.     Form 20-F  [X]  Form 40-F  [  ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1)  [  ]
Note:  Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.



SUBMITTED HEREWITH

99.1
99.2
99.3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
RepliCel Life Sciences Inc.

/s/ Andrew Schutte 
Andrew Schutte, President
Date:  September 13, 2023

 EX-99.1 2 ex99_1.htm EXHIBIT 99.1 - NEWS RELEASE REGARDING DEVICE UPDATE

NEWS RELEASE

RepliCel Announces DermaPrecise™ Development Milestone, Updates Arbitration Proceedings
VANCOUVER, BC, CANADA – September 13, 2023 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing novel, next-generation injection technologies as well as regenerative medicine products in aesthetics and orthopedics, provides development update.
RepliCel is pleased to announce the delivery of the User Requirement Specification from our primary vendor, A.M.I. “We have received testing data, confirming the device will function according to our designated parameters. DermaPrecise™ has illustrated its value proposition by controlling injections based on volume, depth and sheer force” Schutte stated. “We believe this comprehensive testing data will be key in business development efforts going forward.” RepliCel anticipates completing the development phase in 2023. The next step will be securing a contract manufacturer in North America. A complete timeline for approval will be articulated at the Annual General Meeting. RepliCel intends to provide updates as development milestones are achieved.
RepliCel further provides an update regarding the ongoing ICDR proceedings with the Shiseido Group. In response to numerous inquiries, the Company refers to the ICDR rules Article 40, which stipulates that the parties must keep arbitration proceedings confidential; however, the Company is required, by law, to disclose material events. The Company confirms that an award will be a material event to be disclosed in a timely manner, in accordance with applicable securities laws.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated but is the subject of an arbitration regarding Shiseido’s rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
1 | Page
RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe.
MainPointe Pharmaceuticals has an exclusive distribution agreement for the DermaPrecise™ device and consumables in the United States, subject to income. MainPointe is expected to fund the FDA approval process in the United States. Please visit replicel.com for additional information.
For more information, please contact:
Andrew Schutte, CEO and President
604-248-8693
info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

2 | Page
 EX-99.2 3 ex99_2.htm EXHIBIT 99.2 - NEWS RELEASE ANNOUNCING MCTO UPDATE



NEWS RELEASE


REPLICEL LIFE SCIENCES INC.
Suite 900 – 570 Granville Street
Vancouver, BC V6C 3P1
Telephone: (604) 248-8730 Fax: (604) 248-8690

RepliCel Provides Default Status Update
VANCOUVER, BC – September 13, 2023 - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2), (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is providing a default status report in accordance with the alternative information guidelines set out in National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”).
Due to the untimely passing of the Company’s CFO at the time, on August 30, 2023 the Company announced (the “Default Announcement”) that it made an application to the British Columbia Securities Commission (the “BCSC”) to approve a temporary management cease trade order (“MCTO”) on the basis that it would be unable to file its interim financial statements, accompanying management’s discussion and analysis and required certifications for the three and six-month periods ended June 30, 2023  (the “Interim Filings”) on or before the prescribed filing deadline of August 29, 2023 as required by National Instrument 51-102, Continuous Disclosure Obligations and NI 52-109, Certification of Disclosure in Issuer’s Annual and Interim Filings, respectively. The application was approved by the BCSC on August 29, 2023 and the MCTO was issued by the BCSC on August 30, 2022. The MCTO prohibits trading in securities of the Company by certain insiders of the Company, whether direct or indirect. The MCTO requires the Interim Filings to be filed on or before October 30, 2023.  The Company anticipates that the Interim Filings will be filed on or before October 27, 2023.
There have been no material changes to the information contained in the Default Announcement or any other changes required to be disclosed under NP 12-203.
The Company will continue to provide bi-weekly updates, as required by NP 12-203, until the Interim Filings have been filed. The Company confirms it will continue to satisfy the provisions of the alternative information guidelines set out in Sections 9 and 10 of NP 12-203 so long as it remains in default of the requirement to file the Interim Filings.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
1 | Page

The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated but is the subject of an arbitration regarding Shiseido’s rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. MainPointe Pharmaceuticals has an exclusive distribution agreement for the DermaPrecise™ device and consumables in the United States, subject to income. MainPointe is expected to fund the FDA approval process in the United States. Please visit replicel.com for additional information.
Notable Facts:
•
RepliCel’s three cell therapy products have now been tested in over 100 patients in four countries on three continents.
•
RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel’s products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.

Please visit www.replicel.com for additional information.
     
For more information, please contact:
Andrew Schutte, CEO and President
info@replicel.com
Cautionary Statement Regarding Forward-Looking Statements
This news release includes certain “forward-looking statements” under applicable Canadian securities legislation that are not historical facts. Forward-looking statements involve risks, uncertainties, and other factors that could cause actual results, performance, prospects, and opportunities to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements made in this news release include, but are not limited, to: the Company’s expectation that the Interim Filings will be made by October 27, 2023. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements including that: the Company may not be able to file the Interim Filings by October 27, 2023 and any additional risks set out in the Company’s public documents filed on SEDAR at www.sedarplus.ca. Although the Company believes that the assumptions and factors used in preparing the forward-looking statements are reasonable, undue reliance should not be placed on these statements, which only apply as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. Except where required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
2 | Page
 EX-99.3 4 ex99_3.htm EXHIBIT 99.3 - MATERIAL CHANGE REPORT

51-102F3
MATERIAL CHANGE REPORT
Item 1   Name and Address of Company
RepliCel Life Sciences Inc. (“RepliCel” or the “Company”)
900 – 570 Granville Street
Vancouver, BC, V6C 3P1
Item 2   Date of Material Change
September 13, 2023
Item 3   News Release
The news releases dated September 13, 2023 were disseminated through Market News and Stockwatch.
Item 4   Summary of Material Change
The Company provided a development update regarding the delivery of the User Requirement Specification, an update regarding the ongoing ICDR proceedings with the Shiseido Group and a default status report in accordance with the alternative information guidelines set out in National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”).
Item 5   Full Description of Material Change.
5.1         Full Description of Material Change
The Company announced the delivery of the User Requirement Specification from its primary vendor, A.M.I.  It received testing data, confirming the device will function according to its designated parameters. DermaPrecise™ has illustrated its value proposition by controlling injections based on volume, depth and sheer force.  The Company believes this comprehensive testing data will be key in business development efforts going forward. The Company anticipates completing the development phase in 2023. The next step will be securing a contract manufacturer in North America. A complete timeline for approval will be articulated at the Annual General Meeting. RepliCel intends to provide updates as development milestones are achieved.
RepliCel further provides an update regarding the ongoing ICDR proceedings with the Shiseido Group. In response to numerous inquiries, the Company refers to the ICDR rules Article 40, which stipulates that the parties must keep arbitration proceedings confidential; however, the Company is required, by law, to disclose material events. The Company confirms that an award will be a material event to be disclosed in a timely manner, in accordance with applicable securities laws.
Due to the untimely passing of the Company’s CFO at the time, on August 30, 2023 the Company announced (the “Default Announcement”) that it made an application to the British Columbia Securities Commission (the “BCSC”) to approve a temporary management cease trade order (“MCTO”) on the basis that it would be unable to file its interim financial statements, accompanying management’s discussion and analysis and required certifications for the three and six-month periods ended June 30, 2023  (the “Interim Filings”) on or before the prescribed filing deadline of August 29, 2023 as required by National Instrument 51-102, Continuous Disclosure Obligations and NI 52-109, Certification of Disclosure in Issuer’s Annual and Interim Filings, respectively. The application was approved by the BCSC on August 29, 2023 and the MCTO was issued by the BCSC on August 30, 2022. The MCTO prohibits trading in securities of the Company by certain insiders of the Company, whether direct or indirect. The MCTO requires the Interim Filings to be filed on or before October 30, 2023.  The Company anticipates that the Interim Filings will be filed on or before October 27, 2023.

There have been no material changes to the information contained in the Default Announcement or any other changes required to be disclosed under NP 12-203.
The Company will continue to provide bi-weekly updates, as required by NP 12-203, until the Interim Filings have been filed. The Company confirms it will continue to satisfy the provisions of the alternative information guidelines set out in Sections 9 and 10 of NP 12-203 so long as it remains in default of the requirement to file the Interim Filings.
5.2        Disclosure for Restructuring Transactions
N/A
Item 6   Reliance on subsection 7.1(2) or (3) of National Instrument 51-102
N/A
Item 7   Omitted Information
None
Item 8   Executive Officer
Contact:          Andrew Schutte, CEO and President
Telephone:      604.248.8693
Item 9   Date of Report
September 13, 2023


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