0001213900-24-030687.txt : 20240405 0001213900-24-030687.hdr.sgml : 20240405 20240405112656 ACCESSION NUMBER: 0001213900-24-030687 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20240404 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240405 DATE AS OF CHANGE: 20240405 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: 24825408 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 ea0203326-8k_inmed.htm CURRENT REPORT
false 0001728328 A1 BC 0001728328 2024-04-04 2024-04-04 0001728328 dei:FormerAddressMember 2024-04-04 2024-04-04 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): April 4, 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 4, 2024, the Company announced additional preclinical data demonstrating INM-901’s positive pharmacological effects in the potential treatment of Alzheimer’s disease (“AD”).

 

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 4, 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 4, 2024 By: /s/ Eric A Adams
    Eric A Adams
President & CEO

 

 

2

 

 

 

EX-99.1 2 ea020332601ex99-1_inmed.htm NEWS RELEASE, DATED APRIL 4, 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’s INM-901 Demonstrates Favorable Pharmacological and Behavioral Effects in In Vivo Preclinical Alzheimer’s Disease Studies

 

INM-901 receptor binding studies indicate preferential signaling agonism for CB1/CB2 and impacts the PPAR signaling pathway

 

In Vivo studies demonstrate INM-901 reduces neuroinflammation and improves neuronal function

 

Molecular analysis data further explains previously reported observations in behavioral studies on locomotion, memory and cognition

 

Vancouver, BC – April 04, 2024 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary cannabinoid analogs, today announced additional preclinical data demonstrating INM-901’s positive pharmacological effects in the potential treatment of Alzheimer’s disease (“AD”).

 

Dr. Eric Hsu, Senior Vice President of Preclinical Research and Development at InMed, stated, “The recent results demonstrating pharmacological effects in in vivo disease models continue to validate INM-901 as a potential treatment of AD. We are particularly encouraged with indications that INM-901 has multiple potential mechanisms of action as a preferential signaling agonist for both cannabinoid 1 (“CB1”) and cannabinoid 2 (“CB2”) receptors, as well as impacting the peroxisome proliferator-activated receptor (“PPAR”) signaling pathway. There continues to be a major unmet medical need for this multi-factorial disease and differentiated therapeutic mechanisms may play an important role. We believe the development of INM-901 may address several pathological factors including neuroinflammation, neuroprotection and neuritogenesis.”

 

Several preclinical studies were conducted in well-characterized AD models. A summary of recent INM-901 preclinical study results includes:

 

INM-901 is a preferential signaling agonist of the CB1/CB2 receptors and impacts the PPAR signaling pathway,

 

INM-901 demonstrates reduced neuroinflammation and improved neuronal function,

 

INM-901 mRNA data supports the observations made in the previously released behavior studies in locomotor activity, cognition and memory.

 

Previous studies of INM-901 showed the potential to target several biological pathways associated with AD, including neuroprotection to the differentiated neuronal cells from beta-amyloid peptide-induced toxicity and improvement of neuronal function via extension of neurite length, a potential breakthrough in the treatment of AD.

 

 

 

 

The Role of CB1, CB2 and PPAR in the treatment of Alzheimer’s

 

CB1 and CB2 receptors are both part of the endocannabinoid system and are found throughout the body, including in the brain. CB1 receptors are primarily located in the central nervous system, particularly in areas involved in memory, cognition and motor function, while CB2 receptors are involved in modulating neuroinflammation and immune responses.

 

Activation of CB1 and CB2 receptors has been shown to have neuroprotective effects, meaning they can help protect brain cells from damage and death. In AD, where neuronal death is a hallmark feature, enhancing the activity of these receptors may help to slow down the progression of the disease. Activation of these receptors and other cellular receptors has also been shown to have an impact on neuroinflammation. As neuroinflammation is also believed to contribute to the progression of AD, targeting these receptors could help alleviate this inflammatory response. While further research is needed to fully understand the role of CB1 and CB2 receptors in AD, INM-901 could offer novel therapeutic strategies for the treatment of this devastating condition. (1)(2)

 

Peroxisome proliferator-activated receptors (“PPARs”) are also considered potential therapeutic targets for neurodegenerative disorders such as AD. PPAR’s are ligand-activated transcription factors of nuclear hormone receptor superfamily comprising of the following three subtypes: alpha (“PPAR-α”), gamma (“PPAR-γ”), and beta/delta (“PPAR-β/δ”). Activation of PPAR-α reduces triglyceride level and is involved in regulation of energy homeostasis. Activation of PPAR-γ causes insulin sensitization and enhances glucose metabolism, whereas activation of PPAR-β/δ enhances fatty acids metabolism. (3)(4)

 

Next steps advancing preclinical studies

 

InMed intends to accelerate the development of its AD program. Long-term behavioural and mechanism of action / receptor interaction studies are underway with data read-out expected in calendar 3Q 2024. Development of the chemistry, manufacturing and controls (“CMC”) for drug substance and oral drug product formulation are on-going.

 

Limited treatment options for Alzheimer’s disease - a major unmet medical need

 

Approved AD medications primarily address symptoms related to memory and cognitive function via the reduction of beta-amyloid plaques. These medications are aimed at removing amyloid plaque build-up between the neurons in the brain; however, they do not actively restore or rebuild deteriorating neurons and, thus, do not reverse AD progression. In addition, use of these treatments can be limited due to significant side effects, including inflammation and bleeding in the brain. Several large pharmaceutical companies such as Eli Lilly, Roche, AbbVie, Eisai and Biogen lead research and commercialization efforts in AD drug development.

 

References:

 

(1)Cannabinoid Receptors in the Central Nervous System: Their Signaling and Roles in Disease
(2)Cannabinoid CB2 Receptors in Neurodegenerative Proteinopathies: New Insights and Therapeutic Potential
(3)The peroxisome proliferator-activated receptor: A family of nuclear receptors role in various diseases
(4)PPARs in the central nervous system: roles in neurodegeneration and neuroinflammation

 

Learn more about InMed’s INM-901 program:

 

https://www.inmedpharma.com/pharmaceutical/inm-901-for-alzheimers-disease/

 

2

 

 

About InMed:

 

InMed Pharmaceuticals is a global leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary cannabinoid analogs. Together with our subsidiary, BayMedica LLC, we have unparalleled cannabinoid manufacturing capabilities to serve a spectrum of consumer markets, including pharmaceutical and health and wellness. We are a clinical-stage company developing a pipeline of rare cannabinoid therapeutics with programs in Alzheimer’s disease, age-related macular degeneration, glaucoma, and epidermolysis bullosa. 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

 

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. Forward-looking information in this news release includes statements about: the efficacy of INM-901, INM-901’s ability to treat AD, marketability and uses for INM-901, the results of further studies into INM-901 and acceleration of the development of InMed’s AD 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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Cover
Apr. 04, 2024
Entity Addresses [Line Items]  
Document Type 8-K
Amendment Flag false
Document Period End Date Apr. 04, 2024
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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