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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:
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.
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