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 18, 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 SinceLast 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 exchangeon 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 18, 2025, the Company announced the successful completion of pharmacokinetic (“PK”) studies in large animal models for its Alzheimer’s disease candidate INM-901.
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 18, 2025 |
| 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: November 19, 2025 | By: | /s/ Eric A Adams |
| Eric A Adams <br><br>President & CEO |
2
Exhibit 99.1
| NASDAQ: INM<br><br> <br><br><br> <br>1445 – 885 West Georgia St.<br> Vancouver, BC, Canada V6C 3E8<br> Tel: +1.604.669.7207<br> Email: info@inmedpharma.com<br> www.inmedpharma.com |
|---|
InMed Announces Successful Completion of PharmacokineticStudies in Large Animal Model for its Alzheimer’s Disease Candidate INM-901
| ● | Data demonstrate a favorable bioavailability profile of INM-901 oral formulation |
|---|---|
| ● | Data will support design and planning of first in human clinical trials |
| --- | --- |
| ● | Preparing for pre-IND meeting with the FDA |
| --- | --- |
Vancouver, British Columbia – November18, 2025 – InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed” or the “Company”), a pharmaceutical company developing a pipeline of proprietary small-molecule drug candidates for diseases with high unmet medical need, today announced the successful completion of pharmacokinetic (“PK”) studies in large animal models for its Alzheimer’s disease candidate INM-901.
This marks the first preclinical study in which the oral formulation of INM-901 was administered in large animals. The results provide additional data in guiding decisions in the design of a human Phase 1 clinical trial program.
Positive PK and Neurological Assessment Results
Over a seven-day dosing period, the studies demonstrated robust bioavailability in in vivo models. INM-901 achieved what is anticipated to be therapeutic levels of systemic exposure, supporting its potential utility in neurodegenerative disorders such as Alzheimer’s disease.
In addition, neurological assessments evaluating general attitude, behavior, and motor function revealed no adverse neural or behavioral effects, reinforcing the compound’s favorable profile and supporting its continued advancement toward first-in-human clinical trials.
In parallel, InMed has completed additional chemistry, manufacturing, and controls (“CMC”) development to scale the INM-901 manufacturing process in preparation for Investigational New Drug (“IND”)-enabling studies and regulatory interaction with the Food and Drug Administration (“FDA’).
Dr. Eric Hsu, Senior Vice President, Preclinical Research and Development at InMed, commented, “The successful completion of our first large animal PK study is very encouraging for the INM-901 program. The data supports the clinical applicability of our INM-901 oral formulation and provides important insights as we plan and design our IND-enabling studies and Phase 1 clinical trials. Furthermore, the neurological assessments strengthen our confidence in the compound’s overall safety profile.”
Next Development Steps:
| ● | Advancing CMC activities for scale-up and supply |
|---|---|
| ● | Dose ranging studies in two species |
| --- | --- |
| ● | Preparing for a pre-IND meeting with the FDA |
| --- | --- |
| ● | GLP-enabling studies to support an IND submission |
| --- | --- |
About InMed:
InMed Pharmaceuticals is a pharmaceutical drug development 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-901; the favorable bioavailability profile of INM-901 oral formulation; planning and preparation for pre-IND meeting with the FDA; positive results demonstrating robust bioavailability of INM-901; no adverse neural or behavioral effects using INM-901; the clinical applicability of our INM-901 oral formulation; INM-901’s overall safety profile and next development steps including advancing CMC, dose ranging and GLP studies.
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.