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 14, 2023
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.<br><br> <br>Suite 310 - 815 W. Hastings Street,<br><br> <br>Vancouver, B.C.<br><br> <br>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 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 8.01 Other Events
On November 14, 2023, InMed Pharmaceuticals Inc. announced financial results for the first quarter of fiscal year 2024, ended September 30, 2023.
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 14, 2023 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document<br> and included as Exhibit 101) |
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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 14, 2023 | By: | /s/ Jonathan Tegge |
| Jonathan Tegge<br><br> <br>Interim, Chief Financial Officer |
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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 Reports First Quarter Fiscal 2024 FinancialResults and Provides Business Update
Vancouver, BC – November 14, 2023 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today reports financial results for the first quarter of the fiscal year 2024 which ended September 30, 2023.
The Company’s full financial statements and related MD&A for the first quarter ended September 30, 2023, are available at www.inmedpharma.com, www.sedar.com and at www.sec.gov.
Eric A. Adams, InMed Chief Executive Officer, commented, “We are pleased with the continued advancements across our pharmaceutical programs and commercial operations. We are particularly excited with the recent candidate selection and official launch of our INM-901 preclinical program targeting the treatment of Alzheimer’s disease, representing a unique and innovative treatment approach compared to current options available to patients. Our commercial subsidiary, BayMedica, continues to make steady progress as a B2B supplier of rare cannabinoids to the Health and Wellness sector as our trailing 12-month sales trend continues to show steady growth.”
Adams continued, “Furthermore, the successful completion of a recent financing further strengthens our balance sheet and provides additional financial stability in a particularly challenging capital markets environment. These additional funds extend our cash runway into calendar 3Q 2024.”
Business Update
Pharmaceutical DevelopmentPrograms
Neurodegenerative Diseases Program INM-901:Demonstrates unique pharmacological effects in Alzheimer’s disease
On October 24, 2023, the Company announced it has selected a lead Alzheimer’s disease drug candidate, named INM-901, following positive results from several proof-of-concept studies in a validated Alzheimer’s disease treatment model. InMed will be advancing INM-901, a cannabinoid analog, in its pharmaceutical drug development program. Based on early in vitro research, INM-901 showed potential to target several biological pathways associated with Alzheimer’s, including neuroprotection to the brain neurons from beta-amyloid peptide-induced toxicity and targeting neuronal function improvement via extension of neurite length. In addition to these encouraging invitro testing outcomes, INM-901 demonstrated favorable results in an in vivo preclinical Alzheimer’s proof-of-concept model. When compared to the placebo treated Alzheimer’s disease group in these preclinical studies, INM-901 treatment groups demonstrated a trend towards improvement in cognitive function and memory, locomotor activity, anxiety-based behavior and sound awareness.
Next stages of advanced preclinical studies are underway which will include drug distribution, metabolism (elimination of the drug from the body), pharmacokinetics (how the body interacts with the administered drug) and continuation of pharmaceutical drug development activities such as manufacturing and formulation.
Dermatology ProgramINM-755: Assessing potential partnership opportunities
In the calendar 2Q 2023, we announced safety and efficacy results from the Phase 2 clinical trial, called 755-201-EB (the “Phase 2 Trial”), for the treatment of symptoms related to EB. The data showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol cream versus the control cream alone. Further development of the INM-755 CBN cream is expected to extend beyond its application in EB, potentially encompassing broader indications related to chronic itch with larger target populations and potential commercial opportunities. The Company continues to assess potential partnership opportunities for the advancement of INM-755.
The Company recently gave an oral presentation of an abstract describing the Phase 2 clinical study of investigational drug INM-755 CBN cream for the treatment of symptoms in patients with epidermolysis bullosa (“EB”), a rare genetic skin disease, at the 12th World Congress on Itch (WCI), held in Miami on November 5-7, 2023. A copy of the poster and other presentation materials will be made available on the Company’s website.
Full data and results of the Phase 2 clinical trial will be published shortly in Itch*,* the official journal of the International Forum for the Study of Itch (IFSI).
BayMedica CommercialSubsidiary
BayMedica, a leading supplier of non-intoxicating rare cannabinoids to the health and wellness sector, continues to experience robust year-over-year revenue growth. BayMedica had sales of $0.90M for the three months ended September 30, 2023, representing a 181% increase over the same quarter in the previous year. While sales increased year-over-year, there was a decrease in revenue of 61% from the previous quarter. The changes in revenue can be attributed mainly to distributor order patterns and product mix, which may lead to occasional quarter-over-quarter decreases. However, we anticipate sustained growth as the market expands and brands continue to innovate by incorporating new cannabinoid ingredients in their product mix.
The Company continues to make progress lowering manufacturing costs that should improve margins over time. Additionally, the Company will continue to maintain a strategic focus on aligning production and inventory levels with sales demand and estimated forecasts.
BayMedica will have a booth at the upcoming MJBiz Conference in Las Vegas from November 28^th^ to December 1^st^, 2023. Representatives of both InMed and BayMedica will be on site to meet with both distributors and end product manufactures of Health and Wellness products containing rare cannabinoids.
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Financial commentary
For the three months ended September 30, 202, the Company recorded a net loss of $2.5M compared with a net loss of $3.5M for the three months ended September 30, 2022.
Research and development and patents expenses were $1.3M for the three months ended September 30, 2023, compared with $1.4M for the three months ended September 30, 2022. The decrease in research and development and patents expenses was due to a combination of lower research supplies expense and decreased activities related to the INM-755 Phase 2 clinical trials. We expect research and development expenses to increase in calendar year 2024 as the Company advances preclinical work in INM-901 and IND enabling studies in ocular disease.
The Company incurred general and administrative expenses of $1.3M for the three months ended September 30, 2023, compared to $1.6M in the three months ended September 30, 2022. The decrease was primarily from a combination of changes in the InMed segment, including lower office and admin fees, accounting and legal fees, stock-based compensation expenses, regulatory fees and consulting fees.
At September 30, 2023, the Company’s cash, cash equivalents and short-term investments were $6.7 million, which compares to $8.9 million at June 30, 2022. Subsequent to the quarter’s close, on October 26, 2023, the Company closed a $5.2 million financing. The Company continues to closely monitor expenses while advancing its pharmaceutical pipeline candidates. Based on current forecasts, the Company expects its cash will be sufficient to fund its planned operating expenses and capital expenditure requirements into the third quarter of calendar year 2024, depending on the level and timing of realizing BayMedica revenues from the sale of products in the Health & Wellness sector as well as the level and timing of our operating expenses.
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**Table 1.**CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
Expressed in U.S. Dollars
| Note | September 30, 2023 (unaudited) | June<br> 30, 2023 | ||||
|---|---|---|---|---|---|---|
| ASSETS | ||||||
| Current | ||||||
| Cash and cash equivalents | ||||||
| Short-term investments | 11 | |||||
| Accounts receivable, net | ||||||
| Inventories | 3 | |||||
| Prepaids and other current assets | ||||||
| Total current assets | ||||||
| Non-Current | ||||||
| Property, equipment and ROU assets, net | 4 | |||||
| Intangible assets, net | 5 | |||||
| Other assets | ||||||
| Total Assets | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||
| Current | ||||||
| Accounts payable and accrued liabilities | 6 | |||||
| Current portion of lease obligations | 9 | |||||
| Deferred rent | ||||||
| Total current liabilities | ||||||
| Non-current | ||||||
| Lease obligations, net of current portion | 9 | |||||
| Total Liabilities | ||||||
| Commitments and Contingencies (Note 14) | ||||||
| Shareholders’ Equity | ||||||
| Common shares, no par value, unlimited authorized shares: 3,328,191 (June 30, 2023 - 3,328,191) issued and outstanding | 7 | |||||
| Additional paid-in capital | 7, 8 | |||||
| Accumulated deficit | ) | ) | ||||
| Accumulated other comprehensive income | ||||||
| Total Shareholders’ Equity | ||||||
| Total Liabilities and Shareholders’ Equity | ||||||
| Related Party Transactions (Note 12) | ||||||
| Subsequent Events (Note 13) |
All values are in US Dollars.
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**Table 2.**CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS (unaudited)
Expressed in U.S. Dollars
| For the Three Months Ended September 30 | |||||
|---|---|---|---|---|---|
| Note | 2023 | 2022 | |||
| Sales | |||||
| Cost of sales | |||||
| Inventory write-down | 3 | ||||
| Gross profit | ) | ||||
| Operating Expenses | |||||
| Research and development and patents | |||||
| General and administrative | |||||
| Amortization and depreciation | 4, 5 | ||||
| Foreign exchange loss | |||||
| Total operating expenses | |||||
| Other Income (Expense) | |||||
| Interest and other income | |||||
| Loss before income taxes | ) | ) | |||
| Tax expense | ) | ||||
| Net loss | ) | ) | |||
| Net loss per share | |||||
| Basic and diluted | ) | ) | |||
| Weighted average outstanding common shares | |||||
| Basic and diluted | **** | **** | **** |
All values are in US Dollars.
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**Table 3.**CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
For the Three Months ended September 30, 2023 and 2022 (unaudited)
Expressed in U.S. Dollars
| Note | 2023 | 2022 | |||
|---|---|---|---|---|---|
| Cash provided by (used in): | |||||
| Operating Activities | |||||
| Net<br> loss | ) | ) | |||
| Items<br> not requiring cash: | |||||
| Amortization<br> and depreciation | 4, 5 | ||||
| Share-based<br> compensation | 8 | ||||
| Amortization<br> of right-of-use assets | |||||
| Interest<br> income received on short-term investments | ) | ) | |||
| Unrealized<br> foreign exchange loss | |||||
| Inventory<br> write-down | 3 | ||||
| Changes<br> in operating assets and liabilities: | |||||
| Inventories | |||||
| Prepaids<br> and other currents assets | |||||
| Other<br> non-current assets | |||||
| Accounts<br> receivable | |||||
| Accounts<br> payable and accrued liabilities | ) | ) | |||
| Deferred<br> rent | ) | ||||
| Deferred<br> revenue | |||||
| Lease<br> obligations | ) | ) | |||
| Total<br> cash used in operating activities | ) | ) | |||
| Investing<br> Activities | |||||
| Sale<br> of short-term investments | |||||
| Purchase<br> of short-term investments | ) | ||||
| Total<br> cash provided by investing activities | |||||
| Financing<br> Activities | |||||
| Shares<br> issued for cash | |||||
| Share<br> issuance costs | ) | ||||
| Total<br> cash provided by financing activities | |||||
| (Decrease)<br> increase in cash during the period | ) | ||||
| Cash<br> and cash equivalents beginning of the period | |||||
| Cash<br> and cash equivalents end of the period | |||||
| SUPPLEMENTARY<br> CASH FLOW INFORMATION: | |||||
| Cash<br> Paid During the Year for: | |||||
| Income<br> taxes | |||||
| Interest | |||||
| SUPPLEMENTARY<br> DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||||
| Preferred<br> investment options to its placement agent |
All values are in US Dollars.
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About InMed:
InMed Pharmaceuticals is a global leader in the research, development, manufacturing and commercialization of rare cannabinoids, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs. We also have significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors. For more information, visit www.inmedpharma.com and https://www.baymedica.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: INM-901 represents a unique and innovative treatment approach compared to current options available to patients; cash runway into calendar 3Q 2024; the next stages of advanced preclinical studies of INM-901, including drug metabolism and pharmacokinetics as well as the initiation of pharmaceutical drug development activities such as manufacturing and formulation; disease-modifying effects in an Alzheimer’s disease treatment model; and the next stage of studies which may show how this cannabinoid analog can improve neuronal function; INM-755 control cream data showing a positive indication of enhanced anti-itch activity versus the control cream alone; further development of the INM-755 CBN cream is expected to extend beyond its application in EB; assessing potential partnership opportunities for the advancement of INM-755; publishing phase 2 results shortly in Itch; anticipating sustained volume growth over a 12-month period; improving margins over time; being a global leader in the research, development, manufacturing and commercialization of rare cannabinoids, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs; having significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors.
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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