0001213900-23-023577.txt : 20230328 0001213900-23-023577.hdr.sgml : 20230328 20230328134037 ACCESSION NUMBER: 0001213900-23-023577 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20230328 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230328 DATE AS OF CHANGE: 20230328 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InMed Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001728328 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39685 FILM NUMBER: 23768204 BUSINESS ADDRESS: STREET 1: SUITE 310, 815 W. HASTINGS STREET CITY: VANCOUVER STATE: A1 ZIP: V6C 1B4 BUSINESS PHONE: (604) 669-7207 MAIL ADDRESS: STREET 1: SUITE 310, 815 W. HASTINGS STREET CITY: VANCOUVER STATE: A1 ZIP: V6C 1B4 8-K 1 ea175909-8k_inmedpharma.htm CURRENT REPORT
0001728328 false A1 BC 0001728328 2023-03-28 2023-03-28 0001728328 dei:FormerAddressMember 2023-03-28 2023-03-28 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

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): March 28, 2023

 

 

 

INMED PHARMACEUTICALS INC.

(Exact Name of Company as Specified in Charter)

 

 

 

British Columbia   001-39685   98-1428279

(State or Other Jurisdiction
of Incorporation)

  

(Commission File Number)

  

(IRS Employer
Identification No.)

 

InMed Pharmaceuticals Inc.
Suite 310 - 815 W. Hastings Street,
Vancouver, B.C.
Canada

   V6C 1B4
(Address of Principal Executive Offices)   (Zip Code)

 

Company’s telephone number, including area code: (604) 669-7207

 

Not applicable

(Former Name or 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 (see General 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 March 28, 2023, the Company announced it has concluded enrollment of its Phase 2 clinical trial using investigational drug INM-755 cannabinol (“CBN”) cream for the treatment of patients with epidermolysis bullosa (“EB”), a rare genetic skin disease.

 

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 March 28, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document and included as Exhibit 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: March 28, 2023 By:

/s/ Eric A Adams

 

Eric A Adams

  President & CEO

 

 

2

 

 EX-99.1 2 ea175909ex99-1_inmedpharma.htm NEWS RELEASE, DATED MARCH 28, 2023

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 Conclusion of Patient Enrollment in Phase 2 Clinical Trial

Investigating INM-755 Cannabinol Cream for Epidermolysis Bullosa

 

●Marks the first time a Phase 2 trial has studied a cannabinol (CBN) formulation as a treatment option for any disease

 

●Data expected to be released in early calendar Q3 2023

 

Vancouver, BC – March 28, 2023 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today announced it has concluded enrollment of its Phase 2 clinical trial using investigational drug INM-755 cannabinol (“CBN”) cream for the treatment of patients with epidermolysis bullosa (“EB”), a rare genetic skin disease.

 

The Phase 2 study, called INM-755-201-EB, enrolled 19 patients. All four subtypes of inherited EB, including EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome were accepted into the trial. The clinical trial is evaluating the safety of INM-755 cannabinol cream and its preliminary efficacy in treating symptoms of itch, pain, and wound healing in patients with epidermolysis bullosa. The study used a within-patient, double-blind design whereby matched index areas are randomized to INM-755 (cannabinol) cream or vehicle cream as a control. Results from this Phase 2 study of INM-755 CBN cream are expected to be released early calendar Q3 2023.

 

“We are delighted to have enrolled 19 patients in InMed’s Phase 2 clinical trial of INM-755 cannabinol cream for EB, a rare disease that has major unmet medical needs,” stated Alexandra Mancini, Senior Vice President of Clinical and Regulatory Affairs at InMed. “We are hopeful results from this Phase 2 study will provide an indication that INM-755 CBN cream may provide symptomatic relief for EB patients. I would personally like to thank all the medical staff at the various sites and our clinical research organization who worked diligently to maximize enrollment, especially considering the challenges of enrolling patients with this extremely rare disease.”

 

“Enrollment completion of this Phase 2 clinical trial of a cannabinol formulation represents an important milestone for InMed and the scientific community studying rare cannabinoids,” said Eric A. Adams, InMed’s President and CEO. “As a class of compounds, we believe cannabinoids hold tremendous therapeutic potential for their innate interaction with the body, however, to date there have been limited evidence-based studies investigating their effects. Taking a rare cannabinoid formulation through several Ph 1 and Ph 2 clinical trials has been a major undertaking. We look forward to the data read-out in the summer, so we can evaluate our strategic options and next steps.”

 

To learn more about this EB study, view the detailed study description on the National Institutes of Health (NIH) clinicaltrials.gov website.

 

INM-755 is a cannabinol (CBN) cream intended as a topical therapy to treat symptoms associated with epidermolysis bullosa (EB) and potentially other dermatological diseases. Preclinical data demonstrate that INM-755 (cannabinol) cream may help relieve hallmark EB symptoms, such as pain, inflammation, wound healing and itch, as well potentially restore the integrity of the skin in a subset of EB Simplex patients. Phase 1 data in healthy volunteers demonstrated INM-755 (cannabinol) cream to be well-tolerated on both normal, intact skin as well as on open wounds and caused no delay in wound healing.

 

 

 

 

Learn more about InMed’s INM-755 EB program:

 

https://www.inmedpharma.com/pharmaceutical/inm-755-for-epidermolysis-bullosa/

 

What is epidermolysis bullosa?

 

Epidermolysis bullosa, or EB, is a group of rare genetic skin diseases characterized by fragile skin that can lead to extensive blistering and wounding. It affects skin and mucous membranes, particularly of the gastrointestinal tract, genitourinary and respiratory systems. It is a debilitating disease affecting a small number of people, thus earning it an orphan-disease status. The disease has no definitive cure and all currently approved treatments are directed towards symptom relief. Learn more: https://www.inmedpharma.com/learn/what-is-epidermolysis-bullosa/.

 

About InMed: InMed Pharmaceuticals is a global leader in the research, development and manufacturing 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.

 

Investor Contact:

 

Colin Clancy

Vice President, Investor Relations & 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: concluding enrollment of its Phase 2 clinical trial using investigational drug INM-755 CBN cream; first time a Phase 2 trial has studied a CBN formulation as a treatment option for any disease; data expected to be released in early calendar Q3 2023; being hopeful results from this Phase 2 study will provide an indication that INM-755 CBN cream may provide symptomatic relief for EB patients; completion of this Phase 2 clinical trial representing an important milestone for InMed and the scientific community studying rare cannabinoids; belief that cannabinoids hold tremendous therapeutic potential for their innate interaction with the body; evaluating our strategic options and next steps.

 

With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: the ability to obtain all necessary regulatory approvals on a timely basis, or at all; and continued economic and market stability. While InMed considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. 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 Security 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.

 

 

 

 

 

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Cover
Mar. 28, 2023
Entity Addresses [Line Items]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 28, 2023
Entity File Number 001-39685
Entity Registrant Name INMED PHARMACEUTICALS INC.
Entity Central Index Key 0001728328
Entity Tax Identification Number 98-1428279
Entity Incorporation, State or Country Code A1
Entity Address, Address Line One Suite 310 - 815 W. Hastings Street
Entity Address, City or Town Vancouver
Entity Address, State or Province BC
Entity Address, Country CA
Entity Address, Postal Zip Code V6C 1B4
City Area Code 604
Local Phone Number 669-7207
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares, no par value
Trading Symbol INM
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
Former Address [Member]  
Entity Addresses [Line Items]  
Security Exchange Name NASDAQ
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