INM InMed Pharmaceuticals Inc

 

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): February 3, 2025

 

 

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 1445 - 885 W. Georgia Street, Vancouver, B.C. Canada		V6C 3E8
(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 February 3, 2025, the Company announced the selection of an intravitreal (‘IVT’) formulation for INM-089 as a drug candidate to be utilized in the Company’s ongoing development program targeting the treatment of 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 February 3, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document and included as Exhibit 101)

 

 

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: February 3, 2025	By:	/s/ Eric A Adams
		Eric A Adams President & CEO

 

 

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Exhibit 99.1

 

NASDAQ: INM   1445 – 885 West Georgia St. Vancouver, BC, Canada V6C 3E8 Tel: +1.604.669.7207 Email: info@inmedpharma.com www.inmedpharma.com

 

InMed Announces INM-089 Intravitreal Formulation in the Treatment of Dry Age-Related Macular Degeneration

 

●

INM-089 IVT formulation selected for continued development

 

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Demonstrated successful delivery at doses up to 10 times the projected therapeutic level, indicating a favorable pharmacokinetic profile and a significant safety margin

 

●

Dose ranging studies completed

 

Vancouver, British Columbia – February 3, 2025. InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed” or the “Company”), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced the selection of an intravitreal (‘IVT’) formulation for INM-089 as a drug candidate to be utilized in the Company’s ongoing development program targeting the treatment of dry age-related macular degeneration (‘AMD’).

 

Michael Woudenberg, InMed’s Chief Operating Officer and Senior Vice President of Chemistry, Manufacturing, and Controls, commented, “We are encouraged by the recent data demonstrating that INM-089 can be successfully delivered as an IVT formulation, offering several advantages for the continued development of this compound in the treatment of dry AMD. The supporting data generated through the IVT formulation underscores its potential as an effective therapeutic approach for this challenging condition.”

 

InMed’s proprietary IVT formulation, combined with the INM-089 active pharmaceutical ingredient (‘API’), has been successfully delivered to the targeted area of the eye in preclinical studies in doses of up to 10 times the calculated safety margin relative to the therapeutic dose level. This INM-089 IVT formulation will be used in the next stages of preclinical studies, including GLP-enabling studies and subsequent stages of clinical development.

 

Additionally, InMed has recently completed a series of dose-ranging in vivo studies. The information from the dose-ranging study will guide us in selecting the appropriate doses for the pivotal preclinical toxicology studies.

 

Intravitreal injection has been the established method for the effective delivery of drugs to the back of the eye and remains the standard of care among retinal specialists. Topical formulations, such as eye drops, face significant challenges in delivering highly lipophilic drugs to this target tissue because the complex anatomy and protective barriers of the eye hinder effective drug permeation.

 

About AMD and need for new treatment options

 

AMD is a common progressive eye disease affecting the macula, or back of the eye, and impedes one’s central vision. An estimated 196 million people worldwide live with AMD. Dry AMD is the most common form, accounting for an estimated 80% of AMD cases. Until recently, there were no treatments for this prevalent disease. Two new treatments have been approved for late-stage dry AMD, also known as geographic atrophy (‘GA’). There remains a major unmet medical need for dry AMD, which impacts an estimated 12.6% of Americans aged 40+.

 

 

INM-089: A promising drug candidate for Dry AMD

 

INM-089 is a small molecule drug candidate in development for the treatment of AMD. Preclinical studies of INM-089 demonstrated significant functional and pathological improvements in a dry AMD disease study model. Results from studies demonstrate that INM-089:

 

●

provides neuroprotection of photoreceptors and improves photoreceptor function;

 

●

improves the integrity of the retinal pigment epithelium;

 

●

reduces extracellular auto fluorescent deposits, a hallmark of dry AMD;

 

●

preserves retinal function in the back of the eye; as well as

 

●

improves thickness of “outer nuclear layer” of the retina where photoreceptors are located.

 

To learn more about InMed’s INM-089 Program in the treatment of, please visit our website: https://www.inmedpharma.com/pharmaceutical/inm-089-for-age-related-macular-degeneration/

 

About InMed:

 

InMed Pharmaceuticals is a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. InMed’s pipeline consists of three separate programs in the treatment of Alzheimer’s, ocular and dermatological indications. For more information, visit www.inmedpharma.com.

 

Investor Contact:

 

Colin Clancy

Vice President, Investor Relations

and Corporate Communications

T: +1 604 416 0999

E: ir@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. 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; and, developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs.

 

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 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.

 

 

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Cover	Feb. 03, 2025
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Feb. 03, 2025
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 1445 - 885 W. Georgia Street,
Entity Address, City or Town	Vancouver
Entity Address, Country	CA
Entity Address, Postal Zip Code	V6C 3E8
City Area Code	604
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Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Shares, no par value
Trading Symbol	INM
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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