8-K
InMed Pharmaceuticals Inc. (INM)
UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d)
of the Securities
Exchange Act of 1934
Date of Report(Date of earliest event reported): November 2, 2023
INMED PHARMACEUTICALS
INC.
(Exact Name ofCompany as Specified in Charter)
| British Columbia | 001-39685 | 98-1428279 |
|---|---|---|
| (State or Other Jurisdiction<br><br> <br>of Incorporation) | (Commission FileNumber) | (IRS Employer<br><br> <br>Identification No.) |
| InMed Pharmaceuticals Inc.<br><br> <br>Suite 310 - 815 W. Hastings Street,<br><br> <br>Vancouver, B.C.<br><br> <br>Canada | V6C 1B4 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Company’s
telephone number, including area code: (604) 669-7207
Not applicable
(Former Nameor Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (seeGeneral Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Shares, no par value | INM | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation
FD Disclosure.
On November 2, 2023, the Company announced that an abstract describing the Phase 2 clinical study of investigational drug INM-755 cannabinol (“CBN”) cream for the treatment of symptoms in patients with epidermolysis bullosa (“EB”), a rare genetic skin disease, has been accepted as an oral presentation at the 12th World Congress on Itch (WCI), being held in Miami on November 5-7, 2023.
The information set forth in this Item 7.01, including Exhibits 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
The following exhibits shall be deemed to be furnished, and not filed:
| Exhibit No. | Description |
|---|---|
| 99.1 | News release, dated November 2, 2023 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and included as Exhibit<br>101) |
1
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 hereunto duly authorized.
| INMED PHARMACEUTICALS INC. | ||
|---|---|---|
| Date: November 2, 2023 | By: | /s/ Eric A Adams |
| Eric A Adams | ||
| President & CEO |
2
Exhibit 99.1
| NASDAQ: INM |
|---|
| Suite 310-815 W. Hastings St. |
| Vancouver, BC, Canada V6C 1B4 |
| Tel: +1.604.669.7207 |
| Email: info@inmedpharma.com |
| www.inmedpharma.com |
InMed Announces Presentation of INM-755 Phase2 Clinical Study Results at 12th World Congress on Itch (WCI) 2023
Vancouver, BC – November 2, 2023 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today announced that an abstract describing the Phase 2 clinical study of investigational drug INM-755 cannabinol (“CBN”) cream for the treatment of symptoms in patients with epidermolysis bullosa (“EB”), a rare genetic skin disease, has been accepted as an oral presentation at the 12th World Congress on Itch (WCI), being held in Miami on November 5-7, 2023.
Presentation details are below:
Abstract Title: INM-755 cannabinol cream demonstrates anti-itch activity in patients with epidermolysis bullosa
Presenting Author: Alexandra Mancini, Senior Vice President, Clinical and Regulatory Affairs, InMed Pharmaceutical Inc.
Session: Hot Topics
Date/Time: Tuesday, November 7 at 4:08 PM ET
The Phase 2 Study:
The Phase 2 study was designed to evaluate the safety of INM-755 CBN cream, which consists of the control cream plus the active pharmaceutical ingredient CBN, and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with EB. All four subtypes of inherited EB, including EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome were accepted into the study. The study used a within-patient, double-blind design whereby matched index areas were randomized to INM-755 CBN cream or to control cream. The data showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol cream versus the control cream alone.
A copy of the poster and other presentation materials will be made available on the Company’s website after the congress.
About InMed:
InMed Pharmaceuticals is a global leader in the research, development, manufacturing and commercialization of rare cannabinoids, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs. We also have significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors. For more information, visit www.inmedpharma.com and www.baymedica.com.
Investor Contact:
Colin Clancy
Vice President, Investor Relations
and Corporate Communications
T: +1.604.416.0999
E: cclancy@inmedpharma.com
Cautionary Note Regarding Forward-Looking Information:
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities laws. Forward-looking information is based on management’s current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking information in this news release includes statements about: presenting the INM-755 Phase 2 clinical study results at the 12th world congress on itch; being a global leader in the research, development, manufacturing and commercialization of rare cannabinoids, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs; having significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors.
Additionally, there are known and unknown risk factors which could cause InMed’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. A complete discussion of the risks and uncertainties facing InMed’s stand-alone business is disclosed in InMed’s Annual Report on Form 10-K and other filings with the Securities and Exchange Commission on www.sec.gov.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.