0001213900-24-033340.txt : 20240416 0001213900-24-033340.hdr.sgml : 20240416 20240416143935 ACCESSION NUMBER: 0001213900-24-033340 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20240416 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240416 DATE AS OF CHANGE: 20240416 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InMed Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001728328 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences 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: 24847364 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 ea0204004-8k_inmed.htm CURRENT REPORT
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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): April 16, 2024

 

 

 

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 April 16, 2024, the Company announced additional preclinical data for INM-089 further demonstrating positive pharmacological effects targeting dry Age-Related Macular Degeneration (“AMD”).

 

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 April 16, 2024  
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: April 16, 2024 By: /s/ Eric A Adams
    Eric A Adams
    President & CEO

 

 

 

 

EX-99.1 2 ea020400401ex99-1_inmed.htm NEWS RELEASE, DATED APRIL 16, 2024

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 Provides Update on INM-089 in the Treatment of Dry Age-Related Macular Degeneration

 

Small molecule drug acting as a preferential signaling ligand for CB1/CB2

 

Delivers improved retinal pigment epithelium integrity, neuroprotection and photoreceptor improvement in in vivo preclinical disease model

 

Vancouver, BC – April 16, 2024 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the research, development, manufacturing, and commercialization of rare cannabinoids and proprietary cannabinoid analogs, today announced additional preclinical data for INM-089 further demonstrating positive pharmacological effects targeting dry Age-Related Macular Degeneration (“AMD”).

 

Dr. Eric Hsu, SVP of Preclinical Research and Development, stated, “We are very excited with the data from recent preclinical studies demonstrating both significant functional and pathological improvements from INM-089 in the AMD model. While a few treatment options are currently available, their efficacy is limited and may be associated with several undesirable side effects. We see an opportunity for INM-089 to slow the progression and to fill a significant gap in the treatment of this chronic disease.”

 

Recent Preclinical Data

 

Data from a recent proof of concept study indicates that INM-089 may be more effective as a therapeutic treatment for dry AMD compared to neovascular, or wet, AMD. More specifically, data suggests INM-089 may be an important candidate for geographic atrophy (“GA”) which is common in more advanced cases of dry AMD, affecting the center of the macula.

 

In vivo preclinical studies in AMD disease models demonstrated the following significant outcomes for INM-089:

 

neuroprotection of photoreceptors as well as improved photoreceptors function;

 

improved integrity of retinal pigment epithelium; and

 

reduction in extracellular autofluorescent deposits, a hallmark of dry AMD.

 

Previously, it was demonstrated that INM-089 preserved retinal function and improved the thickness of the outer nuclear layer of the retina, where photoreceptors are located, in an in vivo AMD disease model.

 

 

 

Importance of CB1/CB2 Receptors

 

INM-089 is proprietary small molecule compound acting as a preferential signaling ligand of cannabinoid receptor 1 (“CB1”) and cannabinoid receptor 2 (“CB2”). CB1 and CB2 receptors are both part of the endocannabinoid system that is found throughout the human body and is responsible for many homeostatic functions. CB1 receptors are primarily located in the brain and central nervous system, while CB2 receptors are involved in modulating neuroinflammation and immune responses.

 

Dry AMD – Unmet Medical Need

 

AMD is a ‘back of the eye’ disease in which a small area in the central portion of the retina, known as the macula, is damaged. AMD affects the central vision and the ability to see fine details. People with advanced AMD in both eyes cannot recognize faces, read, nor drive. Dry AMD is the most common form, accounting for 85-90% of all AMD cases and is a leading cause of blindness in the developed world. Dry AMD is caused by waste proteins and lipids (oily material) that begin to accumulate due to poor circulation and poor waste-flushing in the eye. The advanced stage of dry AMD is referred to as Geographic Atrophy, with approximately 5 million patients globally suffering from GA. The prevalence of GA is projected to continue to rise in the coming years, with an estimated 18.5 million cases globally by the year 2040.(1)

 

Next Steps- Advancing Development Activities

 

InMed has engaged a Contract Development and Manufacturing Organization (“CDMO”) to assist in scale-up manufacturing process development of the active pharmaceutical ingredient (“API”). Furthermore, development work on drug product formulation continues internally to support the next stages of development activities.

 

Additional preclinical activities are on-going to further understand the mechanism of action including receptor interactions and drug metabolism and pharmacokinetics (“DMPK”) studies.

 

References:

 

(1)Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis

 

About InMed:

 

InMed Pharmaceuticals is a global leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary cannabinoid analogs. We are a clinical-stage company developing a pipeline of proprietary cannabinoid-analog therapeutics and dedicated to delivering new treatment alternatives to patients that may benefit from cannabinoid-based pharmaceutical drugs. For more information, visit www.inmedpharma.com.

 

Investor Contact:

 

Colin Clancy

Vice President, Investor Relations

and Corporate Communications

T: +1 604 416 0999

E: cclancy@inmedpharma.com

 

2

 

 

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 statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “potential”, “possible”, “would” and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. 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. Without limiting the foregoing, forward-looking information in this news release includes, but is not limited to, statements about: the efficacy of INM-089, INM-089’s ability to treat AMD, marketability and uses for INM-089, the results of further studies into INM-089 and the further development of InMed’s AMD program.

 

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.

 

 

3

 

 

 

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