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): September 30, 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 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 September 30, 2024, the Company reported financial results for the fiscal year ended June 30, 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:

 

Exhibit No.		Description
99.1		News release, dated September 30, 2024
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: September 30, 2024	By:	/s/ Eric A Adams
		Eric A Adams
		President & CEO

 

 

2

Exhibit 99.1

 

NASDAQ: INM

 

InMed Pharmaceuticals Reports Full Year Fiscal 2024 Financial Results and Provides Business Update

 

●

Advances INM-901 program targeting several biological pathways associated with Alzheimer’s disease

 

●

Further develops INM-089 demonstrating neuroprotection in the treatment of dry Age-related Macular Degeneration

 

●

$4.6M revenues in fiscal year 2024, representing a 11% increase over the previous fiscal year

 

Vancouver, BC – September 30, 2024 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced financial results for the fiscal year ending June 30, 2024 and provided a business update on the pharmaceutical drug development programs as well as the commercial segment for its wholly-owned subsidiary, BayMedica, LLC (“BayMedica”).

 

The Company’s full financial statements and related MD&A for the fiscal year ended June 30, 2024, are available at www.inmedpharma.com and at www.sedar.com.

 

Financial and operating highlights for fiscal 2024:

 

●

As of June 30, 2024, the Company’s cash, cash equivalents and short-term investments were $6.6M

 

●

For the year ended June 30, 2024, the Company recorded a net loss of $7.7M, compared with a net loss of $7.9M for the previous year

 

●

Advanced INM-901 program with long-term preclinical studies, targeting multiple mechanisms of action in the treatment of Alzheimer’s disease

 

●

Launched INM-089 preclinical program in the treatment of Age-Related Macular Degeneration (“AMD”) and reported preclinical data demonstrating positive pharmacological effects

 

●

Strengthened patent portfolio with the issuance of three new U.S. patents across formulation and method of use, manufacturing and drug delivery formulation

 

●

Total sales for BayMedica were $4.6M in fiscal year 2024, representing an 11% increase over the previous fiscal year

 

Eric A. Adams, InMed Chief Executive Officer commented, “In fiscal year 2024, we made significant progress in our pharmaceutical pipeline, advancing two preclinical programs targeting Alzheimer’s disease and dry AMD. Both these programs utilize proprietary small molecule drug candidates that activate both the CB1 and CB2 receptors, as well as other disease-relevant receptors. We are especially encouraged by the rapid advancement of the INM-901 program, which has been in development for less than a year since the drug candidate was selected last October.”

 

 

The Alzheimer’s treatment landscape has shifted significantly in recent years, underscoring the need for innovative, disease-modifying therapies and more convenient treatment options. Industry leaders now recognize that treating a complex disease like Alzheimer’s will likely require a combination of therapies or a multi-faceted approach. With INM-901, InMed has developed an orally available small molecule that has demonstrated disease-modifying effects in preclinical studies by targeting multiple biological pathways, positioning us at the forefront of innovative Alzheimer’s research.”

 

Business Update

 

Pharmaceutical Development Programs

 

INM-901: Targeting several biological pathways associated with Alzheimer’s disease

 

INM-901 is a proprietary small molecule drug candidate with multiple mechanisms of action in development as a potential treatment for Alzheimer’s disease. Throughout fiscal 2024, the Company announced several key findings for INM-901:

 

●

A preferential signaling agonist of the CB1/CB2 receptors and has been shown to have neuroprotective effects, helping protect the neurons in the brain from damage and cell death

 

●

Impacts the peroxisome proliferator-activated receptors (“PPARs”), which have been shown to play an important role in diabetes and are also considered as one of the potential therapeutic targets for neurodegenerative disorders such as Alzheimer’s disease.

 

●

Demonstrates reduced neuroinflammation and improved neurite growth and neuronal function, indicating the potential to restore damage caused by Alzheimer’s disease.

 

●

Can be administered orally and achieve therapeutic levels in the brain comparable to those obtained through intraperitoneal (“IP”) injection, offering many potential advantages over routes of administration of the currently approved products; and

 

●

Demonstrates significant improvement in cognitive function, memory, locomotor activity, anxiety-based behavior and sound awareness in long term preclinical behavioural studies

 

InMed continues to accelerate the development of its Alzheimer’s program, with additional molecular analysis of a preclinical long-term dosing study currently underway to better define the mechanisms of action. Data read-out is expected in the coming months. Additionally, the development of the chemistry, manufacturing, and controls (“CMC”) for both the drug substance and the drug product formulation is ongoing, with GLP studies in the planning stages to support an IND submission.

 

INM-089: Neuroprotection in the treatment of dry AMD

 

INM-089 is a proprietary small molecule drug candidate being studied in the treatment of dry AMD. Throughout fiscal 2024, the Company reported preclinical data for INM-089 demonstrating positive pharmacological effects including.

 

●

Data 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 a more advanced stage of dry AMD

 

●

Enhanced neuroprotection of photoreceptors as well as improved photoreceptor function

 

●

Improved integrity of retinal pigment epithelium

 

●

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

 

INM-755: Dermatology Program – Continuing to seek strategic partnerships

 

Further development of the INM-755 CBN cream is expected to extend beyond its application in Epidermolysis bullosa (“EB”), potentially encompassing broader indications related to chronic, severe itch with larger target populations and potential commercial opportunities. InMed continues to assess potential partnership opportunities for the advancement of INM-755.

 

Continues to strengthen intellectual property portfolio

 

InMed continues to develop its patent portfolio and increase the commercial value of its programs to ensure the long-term protection of our drug research and development efforts. In recent months, InMed has been issued three U.S. patents: one for its formulation and method of use in the treatment of EB and related connective tissue disorders, one for a biosynthesis manufacturing processes and one for an ocular drug delivery formulation.

 

BayMedica commercial subsidiary

 

BayMedica, a leading supplier of non-intoxicating rare cannabinoids to the health and wellness sector, has experienced sustained revenue growth during the fiscal year 2024, reaching $4.6M, representing an 11% increase over the previous year. Sales and marketing efforts will remain focused on products that contribute highest margins, where BayMedica continues to hold a strong competitive position.

 

Financial commentary:

 

For the year ended June 30, 2024, the Company recorded a net loss of $7.7M, compared with a net loss of $7.9M for the previous year.

 

Research and development and patents expenses were $3.8M for year ended June 30, 2024, compared with $3.7M for the year ended June 30, 2023. However, we expect our research and development expenses to increase significantly in future periods as we continue to implement our business strategy. 

 

The Company incurred general and administrative expenses of $5.3M for the year ended June 30, 2024, compared to $5.8M in the previous year. The decrease was primarily from a combination of changes in the InMed segment, including lower office and admin fees and investor relations expenses. This was offset by a slight increase in sales and marketing expenses within the BayMedica segment.

 

 

The Company realized sales of $4.6M in our BayMedica segment for the year ended June 30, 2024, representing an increase of $0.5M, or 11%, for the year ended June 30, 2024, as compared to the year ended June 30, 2023.

 

As of June 30, 2024, we had cash, cash equivalents and short-term investments of $6.6 million The Company expects its cash will be sufficient to fund its planned operating expenses and capital expend to the end of the fourth quarter of calendar year 2024, depending on the level and timing of realizing BayMedica revenues as well as the level and timing of the Company’s operating expenses.

 

Table 1. Consolidated Balance Sheet

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

Expressed in U.S. Dollars

 

		June 30,				June 30,
		2024				2023
		(unaudited)
		$				$
ASSETS
Current
Cash and cash equivalents			6,571,610				8,912,517
Short-term investments			43,064				44,422
Accounts receivable (less provision for credit losses of $nil and $66,775 in June 30, 2024 and 2023, respectively)			352,838				260,399
Inventories, net			1,244,324				1,616,356
Prepaids and other current assets			477,749				498,033
Total current assets			8,689,585				11,331,727
Non-Current
Property, equipment and ROU assets, net			1,249,999				723,426
Intangible assets, net			1,783,198				1,946,279
Other assets			100,000				104,908
Total Assets			11,822,782				14,106,340
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
Accounts payable and accrued liabilities			1,654,011				1,608,735
Current portion of lease obligations			317,797				375,713
Deferred rent			-				16,171
Total current liabilities			1,971,808				2,000,619
Non-current
Lease obligations, net of current portion			644,865				15,994
Total Liabilities			2,616,673				2,016,613
Commitments and Contingencies (Note 13)
Shareholders’ Equity
Common shares, no par value, unlimited authorized shares: 8,918,956 and 3,328,191 as of June 30, 2024 and 2023, respectively, issued and outstanding			82,784,400				77,620,252
Additional paid-in capital			35,368,899				35,741,115
Accumulated deficit			(109,075,759	)			(101,400,209	)
Accumulated other comprehensive income			128,569				128,569
Total Shareholders’ Equity			9,206,109				12,089,727
Total Liabilities and Shareholders’ Equity			11,822,782				14,106,340

 

 

Table 2. Consolidated Statements of Operations

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

Expressed in U.S. Dollars

 

		Year Ended
		June 30
		2024				2023
		$				$
Sales			4,597,730				4,135,561
Cost of sales			3,496,817				2,732,525
Gross profit			1,100,913				1,403,036
Operating Expenses
Research and development and patents			3,765,028				3,732,056
General and administrative			5,250,715				5,847,518
Amortization and depreciation			219,600				202,249
Foreign exchange loss			61,921				48,175
Total operating expenses			9,297,264				9,829,998
Other Income (Expense)
Interest and other income			527,901				492,440
Loss before income taxes			(7,668,450	)			(7,934,522	)
Tax expense			(7,100	)			(13,100	)
Net loss for the period			(7,675,550	)			(7,947,622	)
Net loss per share for the period
Basic and diluted			(1.01	)			(3.25	)
Weighted average outstanding common shares
Basic and diluted			7,621,075				2,448,458

 

 

Table 3. Consolidated Statements of Cash Flows

 

InMed Pharmaceuticals Inc.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

For the year ended June 30, 2024 and 2023

Expressed in U.S. Dollars

 

		June 30, 2024				June 30, 2023
		$				$
Cash provided by (used in):
Operating Activities
Net loss			(7,675,550	)			(7,947,622	)
Items not requiring cash:
Amortization and depreciation			219,600				202,249
Share-based compensation			137,714				278,155
Amortization of right-of-use assets			384,918				393,748
Interest income received on short-term investments			(1,250	)			(803	)
Unrealized foreign exchange loss			12,262				1,183
Inventory write-down			305,812				308,937
Credit losses			-				46,775
Changes in operating assets and liabilities:
Inventories			66,220				565,561
Prepaids and other currents assets			20,284				299,192
Other non-current assets			4,908				5,507
Accounts receivable			(92,439	)			(219,147	)
Accounts payable and accrued liabilities			45,282				(806,530	)
Deferred rent			(16,171	)			16,171
Lease obligations			(397,422	)			(426,575	)
Total cash used in operating activities			(6,985,832	)			(7,283,199	)
Investing Activities
Payment of acquisition consideration			-				(500,000	)
Payment of deposit on equipment			-				(1,790	)
Sale of short-term investments			42,082				42,268
Purchase of short-term investments			(42,082	)			(42,268	)
Purchase of property and equipment			(9,293	)			(160,014	)
Total cash (used in) provided by investing activities			(9,293	)			(661,804	)
Financing Activities
Shares issued for cash
share issuance costs
Proceeds from the exercise of pre-funded warrants			175				646
Proceeds from private placement net of issuance costs			4,654,043				10,680,008
Total cash provided by financing activities			4,654,218				10,680,654
Increase in cash during the period			(2,340,907	)			2,735,649
Cash and cash equivalents beginning of the period			8,912,517				6,176,866
Cash and cash equivalents end of the period			6,571,610				8,912,515
SUPPLEMENTARY CASH FLOW INFORMATION:
Cash Paid During the Year for:
Income taxes		$	-			$	-
Interest		$	-			$	-
SUPPLEMENTARY DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Fair value of warrant modification recorded as equity issuance costs		$	3,508,749			$	-
Preferred investment options to its placement agent		$	325,699			$	691,483
Recognition of Right-of-use asset and corresponding operating lease liability		$	968,376			$	-

 

 

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 drug development programs in the treatment of Alzheimer’s, ocular and dermatological indications. Together with our subsidiary BayMedica, we are a global leader in the manufacturing, development and commercialization of products based on rare cannabinoids and their proprietary, small molecule drug analogs. 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 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: expecting revenue fluctuations based on distributor order patterns; remaining optimistic about the long-term growth potential in the rare cannabinoids sector as the business dynamics and commercial opportunities continue to mature; advancing our pharmaceutical pipeline using rare cannabinoids for potential therapeutic applications in dermatology, ocular and neurodegenerative disease; the efficacy of INM-901, INM-901’s ability to treat Alzheimer’s, marketability and uses for INM-901, the results of further studies into INM-901 and acceleration of the development of InMed’s Alzheimer’s program; 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; further development and commercial uses of the INM-755; expectations that the Company’s cash will be sufficient to fund its planned operating expenses and capital expenditure requirements to the end of the fourth quarter of calendar year 2024.

 

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.

 

 

7

v3.24.3

Cover	Sep. 30, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Sep. 30, 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 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
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
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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