Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

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 August 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	News Release dated August 30, 2023.

99.3	Material Change Report dated August 31, 2023.

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: August 31, 2023

NEWS RELEASE

REPLICEL LIFE SCIENCES INC.

Suite 900 – 570 Granville Street

Vancouver, BC V6C 3P1

Telephone: (604) 248-8730 Fax: (604) 248-8690

RepliCel Announces Application for a Management Cease Trade Order

VANCOUVER, BC – August 30, 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, announces that it was not able to file its interim financial statements, management’s discussion and analysis and the required certifications (the “Interim Filings”) for the three and six-month periods ended June 30, 2023 on or before the prescribed filing deadline of August 29, 2023 (the “Interim Filing Deadline”) as required by National Instrument 51-102, Continuous Disclosure Obligations (“NI 51-102”) and NI 52-109, Certification of Disclosure in Issuer’s Annual and Interim Filings, respectively.

The completion of the Interim Filings for the three and six-month periods ended June 30, 2023 has been and will continue to be delayed primarily due to the recent demise of the Company’s Chief Financial Officer, Simon Ma, after a debilitating terminal illness and because Mr. Ma’s successor, who was only just appointed (on August 16, 2023), will need time to settle in to his new role and prepare the Interim Filings.

The Company has filed an application to the British Columbia Securities Commission to approve a temporary management cease trade order (“MCTO”) under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”), which, if granted, will prohibit trading in securities of the Company by certain insiders of the Company, whether direct or indirect. The Company is seeking the MCTO as it is unable to file it Interim Filings within the deadline as required under NI 51-102.

The Company expects to file the Interim Filings on or before October 27, 2023. Since becoming CFO, Mr. Kwok has taken meaningful steps towards remedying the default – he has already obtained access to all of the Company’s financial documents and accounting software and he has begun the accounting process to complete the Interim financials. Mr. Kwok has indicated that he believes the Company can remedy the default by October 27, 2023. The MCTO will be in effect until the Interim Filings are filed. The Company confirms that it will comply with the alternative information guidelines included in NP 12-203 so long as the Interim Filings are outstanding.

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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.

RepliCel has also developed a proprietary injection device (DermaPrecise^TM) 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

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.

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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

August 30, 2023

Item 3 News Release

The news release dated August 30, 2023 was disseminated through Market News and Stockwatch.

Item 4 Summary of Material Change

The Company announced that it was not able to file its interim financial statements, management’s discussion and analysis and the required certifications (the “Interim Filings”) for the three and six-month periods ended June 30, 2023 on or before the prescribed filing deadline of August 29, 2023 (the “Interim Filing Deadline”) as required by National Instrument 51-102, Continuous Disclosure Obligations (“NI 51-102”) and NI 52-109, Certification of Disclosure in Issuer’s Annual and Interim Filings, respectively.

The Company expects to file the Interim Filings on or before October 27, 2023. The MCTO will be in effect until the Interim Filings are filed. The Company confirms that it will comply with the alternative information guidelines included in NP 12-203 so long as the Interim Filings are outstanding.

Item 5 Full Description of Material Change.

5.1 Full Description of Material Change

A full description of the material change is described in Item 4 above and in the News Release which has been filed on SEDAR at www.sedar.com.

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