false
0001728328
A1
BC
0001728328
2024-01-16
2024-01-16
0001728328
dei:FormerAddressMember
2024-01-16
2024-01-16
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):
January 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 January 16, 2024, the Company outlined
key accomplishments from 2023 and provides key strategic priorities for 2024.
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:
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: January 16, 2024 |
By: |
/s/ Eric A Adams |
|
|
Eric A Adams |
|
|
President & CEO |
2
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 Pharmaceuticals Provides Business
Update and Milestones for 2024
| ● | Advancing
INM-901 as a multimodal treatment option for Alzheimer’s Disease |
| ● | Advancing
INM-089 in the treatment of Age-related Macular Degeneration |
| ● | Actively
seeking partnerships to advance INM-755 in Dermatology |
| ● | BayMedica
subsidiary continues to focus on revenue growth and market expansion |
Vancouver, BC – January 16, 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 outlines key accomplishments from 2023
and provides key strategic priorities for 2024.
Eric A. Adams, InMed President and CEO,
commented, “In 2023, we experienced significant progress in both InMed’s pharmaceutical drug development and in BayMedica’s
health and wellness initiatives. Our primary accomplishments throughout the year included a number of key milestones, such as the completion
of a Phase 2 clinical trial and the launch of two new preclinical programs targeting the treatment of Alzheimer’s disease and Age-related
Macular Degeneration (“AMD”).”
Adams continued, “As we embark
on 2024, we are placing increased emphasis on proprietary small molecule drug development candidates in our pharmaceutical pipeline with
two exciting new programs addressing critical unmet medical needs. Firstly, INM-901 for the treatment of Alzheimer’s disease is
showing promise via multiple mechanisms of action, including an increase in neuroprotection and an improvement in neuronal function via
neuritogenesis. Secondly, INM-089 for the treatment of AMD appears to play a role in the preservation of retinal function, proactively
protecting the retinal cells that are responsible for vision. Our focus on developing proprietary cannabinoid analogs over the past two
years has started to pay dividends, evident in their utilization in these two new preclinical programs.”
“Concurrently, BayMedica continues
to drive robust year-over-year revenue growth. The foreseeable future looks promising for the health and wellness segment as demand for
minor cannabinoid ingredients continues to gain momentum.”
Key accomplishments in 2023
| ● | InMed completed a Phase
2 clinical trial of INM-755, studying its safety and efficacy in the treatment of symptoms related to Epidermolysis Bullosa (“EB”).
The data showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol cream versus the control cream alone, warranting
further development. For further detail on results, please see press release dated June 22, 2023. The study results were also selected
as an oral presentation at the World Itch Congress in October 2023. |
| ● | Launched INM-901 program
following positive results from several proof-of-concept preclinical studies in a validated in vivo Alzheimer’s disease model. |
| ● | Launched INM-089 program,
expanding our ocular program into the treatment of AMD. In vivo models demonstrated promise in preserving retinal function and
proactively protecting the retinal cells that are responsible for vision. |
| ● | BayMedica experienced robust
year-over-year revenues in each reported period. |
Priorities for 2024
INM-901 in the treatment of Alzheimer’s
Disease
The Company is highly encouraged by
the initial preclinical data from in vitro and in vivo studies. Existing external research indicates that various cannabinoids
have been shown to have a wide range of impact on Alzheimer’s pathology. Newly approved Alzheimer’s disease medications primarily
address symptoms related to memory and cognitive function via the reduction of beta-amyloid plaques. Some approved treatments may slow
the rate of cognitive decline, but no treatment has been shown to reverse disease effects. INM-901 appears to be active via multiple mechanisms
of action; early research indicates INM-901 has the potential to be effective in reducing beta-amyloid plaques and has the potential to
provide neuroprotective effects and enhanced neuronal function. Additionally, INM-901 treated groups demonstrated improved behavioral,
cognitive and memory outcomes in several Alzheimer’s proof-of-concept studies using in vivo disease models.
The Company has initiated long-term
(6-month) preclinical studies in behavioral models to further evaluate the potential impact of INM-901 in Alzheimer’s disease. Preparations
are underway for the subsequent phase of advanced preclinical studies, encompassing drug distribution, metabolism and active pharmaceutical
ingredient (“API”) and drug product formulation/ manufacturing.
INM-089 in the treatment of AMD
Based on the previous research conducted
with InMed’s initial ocular drug candidate, INM-088 in the treatment of glaucoma, the Company leveraged its know-how to advance
preclinical work with the use of a proprietary analog for the treatment of AMD. Our preclinical research has shown promising results in
preserving retinal function, proactively protecting retinal cells, and enhancing the thickness of the outer nuclear layer of the retina
where photoreceptors are situated.
The Company is currently engaged in
API and drug product formulation work and expects to initiate Investigational New Drug (“IND”)-enabling studies in mid-2024,
with the anticipation of filing an IND application with regulatory authorities in calendar 1H 2025.
INM-755 – In the treatment
of EB
The comprehensive data and
findings from the Phase 2 clinical trial will soon be available on the National Institutes of Health (“NIH”)
clinicaltrials.gov website and the European Union Clinical Trials Register website. Additionally, an abstract will soon be published
in Itch, the official journal of the International Forum for the Study of Itch.
The Company believes that INM-755 holds
promise for further advancement in the treatment of chronic itch and other related ailments and the Company is currently seeking partnerships
for continued development. Due to several factors, including the small size of the trial and the clinically important anti-itch activity
of the underlying cream without study drug, results were not statistically significant, but we believe the results are clinically important
based on additional analyses.
BayMedica – Ingredients supplier to the
health and wellness industry
BayMedica continues to be a leading low-cost/high
quality manufacturer of certain non-psychoactive rare cannabinoids and is an ingredients supplier to brands within the health and wellness
industry. BayMedica demonstrated significant year-over-year revenue growth throughout 2023 and remains focused on making strategic decisions
to capitalize on the revenue generation opportunities as the rare cannabinoid market continues to mature. BayMedica has embraced a predominantly
distributor model to strategically expanding coverage across the US and thereby further amplifying BayMedica’s reach into different
market segments. In 2024, we anticipate consumer brands will increasingly embrace rare cannabinoid ingredients, integrating them into
new product formulations and formats.
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, 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 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
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: placing
increased emphasis on proprietary small molecule drug development candidates; INM-901 shows promise via multiple mechanisms of action,
including an increase in neuroprotection and an improvement in neuronal function via neuritogenesis and has potential to be effective
in reducing beta-amyloid plaques; INM-089 appears to play a role in the preservation of retinal function, proactively protecting the retinal
cells that are responsible for vision and enhancing the thickness of the outer nuclear layer of the retina; the foreseeable future looks
promising for the health and wellness segment as demand for minor cannabinoids ingredients continues to gain momentum; the Company is
highly encouraged by the initial preclinical data from in vitro and in vivo studies; preparations are underway for the subsequent
phase of advanced preclinical studies, encompassing drug distribution, metabolism and API and drug product formulation and manufacturing;
expecting to initiate IND-enabling GLP studies in mid-2024, with the anticipation of filing an IND in calendar 1H 2025; BayMedica making
strategic decisions to capitalize on the revenue generation opportunities; anticipating brands increasingly embracing rare cannabinoid
ingredients, integrating them into new product formulations and statements relating to the Company’s 2024 strategic priorities generally.
With respect to the forward-looking information
contained in this news release, InMed has made numerous assumptions regarding, among other things: continued economic, regulatory and
market stability; delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based
pharmaceutical drugs; and developing a pipeline of cannabinoid-based pharmaceutical drug candidates. 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. Known risk factors include, among others: regulatory
filings may not be filed or approved on a timely basis, or at all. A more 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.
4
v3.23.4
Cover
|
Jan. 16, 2024 |
Entity Addresses [Line Items] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Jan. 16, 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
|
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionISO 3166-1 alpha-2 country code.
+ References
+ Details
Name: |
dei_EntityAddressCountry |
Namespace Prefix: |
dei_ |
Data Type: |
dei:countryCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
+ References
+ Details
Name: |
dei_EntityAddressesLineItems |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:stringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
InMed Pharmaceuticals (NASDAQ:INM)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
InMed Pharmaceuticals (NASDAQ:INM)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024