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
Dateof Report (Date of earliest event reported): November 11, 2022
INMED
PHARMACEUTICALS INC.
(ExactName of Company as Specified in Charter)
| British Columbia | 001-39685 | 98-1428279 |
|---|---|---|
| (State or Other Jurisdiction<br><br> <br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br> <br>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
(FormerName 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<br> Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the<br> Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b)<br> under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c)<br> 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<br><br> <br>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. ☐
Item8.01 Other Events
On November 11, 2022, InMed Pharmaceuticals Inc. announced financial results for the first quarter of fiscal year 2023, ended September 30, 2022.
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<br>release, dated November 11, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the<br> Inline XBRL document 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<br> PHARMACEUTICALS INC. | ||
|---|---|---|
| Date:<br> November 14, 2022 | By: | /s/<br>Brenda Edwards |
| Brenda<br>Edwards Interim, <br><br>Chief Financial Officer |
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Exhibit 99.1
| NASDAQ: INM<br><br> <br>****<br><br> <br>Suite 310-815 W. Hastings St.<br><br> <br>Vancouver, BC, Canada V6C 1B4<br><br> <br>Tel: +1.604.669.7207<br><br> <br>Email: info@inmedpharma.com<br><br> <br>www.inmedpharma.com |
|---|
InMed PharmaceuticalsReports First Quarter Fiscal 2023 Financial Results and Provides Business Update
Vancouver, BC – November 11, 2022 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today reported financial results for the first quarter of fiscal year 2023, ended September 30, 2022.
The Company’s condensed financial statements and related MD&A for the first quarter of fiscal year 2023, ended September 30, 2022 will be available at www.inmedpharma.com and at www.sedar.com.
Eric A. Adams, InMed CEO, states, “In the first quarter of our new fiscal year, we continue to strengthen our pharmaceutical pipeline in dermatology, ocular and neurodegenerative diseases, as well as continue to screen our library of proprietary analogs for additional therapeutic candidates. Throughout the remainder of the year and into calendar year 2023, we have many milestones to look forward to in our clinical and preclinical programs, including the completion of our Phase 2 clinical trial in epidermolysis bullosa as well as advancing our glaucoma program towards human trials.”
Business Update
Pharmaceutical DevelopmentPrograms
INM-755 for the treatmentof Epidermolysis Bullosa (“EB”)
Enrollment and patient treatment in the Company’s Phase 2 clinical trial, 755-201-EB, has continued through the first quarter and is expected to complete during calendar year 2022.
InMed’s Phase 2 clinical trial now has all 11 clinical trial sites fully activated to screen and enroll patients. The clinical trial is taking place in seven countries (Austria, Germany, Greece, France, Italy, Israel and Spain).
InMed is evaluating the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and wound healing in persons with EB over a 28-day treatment period. This study marks the first time cannabinol (“CBN”) has advanced to a Phase 2 clinical trial to be investigated as a therapeutic option to treat a disease.
INM-088 for the treatment of glaucoma
The Company continues to do necessary preclinical work including toxicology and GLP studies in advance of human clinical trials.
Earlier in the year, the Company completed a pre-Investigational New Drug (“pIND”) application discussion with the U.S. Food and Drug Administration (“FDA”) regarding manufacturing, preclinical studies and early clinical development plans for INM-088, a CBN formulation in development for glaucoma. The Company gained alignment with FDA on the design of the initial Phase 1-2 clinical trial to gather preliminary data on the safety and efficacy of INM-088 treatment.
InMed data suggest CBN is the cannabinoid of choice for neuroprotection and lowering intraocular pressure in glaucoma and potentially other ocular diseases.
New cannabinoid analogs for the treatment ofneurodegenerative diseases
The Company continues to advance discovery work to identify an appropriate compound for a preclinical development program for treating neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s disease and Huntington’s disease.
The Company remains focused on the generation of proprietary cannabinoid analogs to support its pharmaceutical drug development programs. As these novel cannabinoid analogs are patentable, they protect the long-term research investment and commercial opportunities.
BayMedica commercial activities
BayMedica commercial activities remain steady as the Company continues to work through existing inventories as a B2B supplier of rare cannabinoids to the health and wellness market. The Company continues to explore potential opportunities for structured supply agreements, commercial collaborations and review other strategic alternatives for the commercial aspect of its business.
Financial and Operational Highlights:
For the three months ended September 30, 2022, the Company recorded a net loss of $3.5 million, or $4.06 per share, compared with a net loss of $3.0 million, or $6.17 per share, for the three months ended September 30, 2021.
Research and development expenses were $1.4 million for the three months ended September 30, 2022, compared with $1.5 million for the three months ended September 30, 2021. The decrease in research and development and patents expenses was primarily due to decreased activities related to the INM-755 Phase 2 clinical trials which were offset by the inclusion of BayMedica operating results following the acquisition date.
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The Company incurred general and administrative expenses of $1.6 million for the three months ended September 30, 2022, compared with $1.4 million for the three months ended September 30, 2021. The increase is due to the inclusion of BayMedica operating results following the acquisition date.
The Company realized sales of $0.3 million in our BayMedica segment for the for the three months ended September 30, 2022, the result of the manufacturing and sale of bulk rare cannabinoid products following the acquisition of BayMedica in October 2021. As the period ended September 30, 2021 predated the acquisition of BayMedica, there are no comparable revenues in 2021.
At September 30, 2022, the Company’s cash, cash equivalents and short-term investments were $9.4 million, which compares to $6.2 million at June 30, 2022. On September 13, 2022, the Company closed a $6.0 million private placement with two healthcare-focused institutional investors. Based on the current forecast, which is subject to potential revisions in the future, the Company’s cash reserves are estimated to last into the second half of fiscal 2023, and possibly into the first quarter of fiscal 2024 (being the third calendar quarter of 2023), depending on the level and timing of realizing revenues from the sale of BayMedica inventory as well as the level and timing of the Company’s operating expenses.
As a result of the decision to de-emphasize the commercial business due to lower demand outlook and downward pricing pressure, the Company incurred a write-down of inventories to net realizable value of $0.6 million during the period ended September 30, 2022.
At September 30, 2022, the Company’s total issued and outstanding shares were 908,766, or 1,510,011 including all outstanding pre-funded warrants which are considered common share equivalents. During the three months ending September 30, 2021, including the pre-funded warrants, the weighted average number of common shares was 865,619, which is used for the calculation of loss per share for the interim period.
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Table 1: Condensed Consolidated InterimBalance Sheets:
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS (unaudited)
As at September 30, 2022 and June 30, 2022
Expressed inU.S. Dollars
| September 30, | June 30, | |||
|---|---|---|---|---|
| 2022 | 2022 | |||
| ASSETS | ||||
| Current | ||||
| Cash and cash equivalents | ||||
| Short-term investments | ||||
| Accounts receivable | ||||
| Inventories | ||||
| Prepaids and other assets | ||||
| Total current assets | ||||
| Non-Current | ||||
| Property, equipment and ROU assets, net | ||||
| Intangible assets, net | ||||
| Other assets | ||||
| Total Assets | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||
| Current | ||||
| Accounts payable and accrued liabilities | ||||
| Current portion of lease obligations | ||||
| Deferred revenue | ||||
| Acquisition consideration payable | ||||
| Total current liabilities | ||||
| Non-current | ||||
| Lease obligations | ||||
| Total Liabilities | ||||
| Shareholders’ Equity | ||||
| Common shares, no par value, unlimited authorized shares: 908,766 (June 30, 2022 - 650,667) issued and outstanding | ||||
| Additional paid-in capital | ||||
| Accumulated deficit | ) | ) | ||
| Accumulated other comprehensive income | ||||
| Total Shareholders’ Equity | ||||
| Total Liabilities and Shareholders’ Equity |
All values are in US Dollars.
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Table 2: Condensed Consolidated InterimStatements of Operations and Comprehensive Loss:
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONSAND COMPREHENSIVE LOSS (unaudited)
For the three months ended September 30, 2022 and 2021
Expressed in U.S. Dollars
| **** | Three Months Ended | **** | ||
|---|---|---|---|---|
| **** | September<br> 30 | **** | ||
| 2022 | 2021 | |||
| Sales | ||||
| Cost of sales | ||||
| Inventory write-down | ||||
| Gross loss | ) | |||
| Operating Expenses | ||||
| Research and development and patents | ||||
| General and administrative | ||||
| Amortization and depreciation | ||||
| Total operating expenses | ||||
| Other Income (Expense) | ||||
| Interest and other income | ||||
| Foreign exchange loss | ) | ) | ||
| Loss before income taxes | ) | ) | ||
| Tax expense | ) | |||
| Net loss for the period | ) | ) | ||
| Net loss per share for the period | ||||
| 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 InterimStatements of Cash Flows:
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS(unaudited)
For the three months ended September 30, 2022 and 2021
Expressed in U.S. Dollars
| 2022 | 2021 | |||
|---|---|---|---|---|
| Cash provided by (used in): | ||||
| Operating Activities | ||||
| Net loss for the period | ) | ) | ||
| Items not requiring cash: | ||||
| Amortization and depreciation | ||||
| Share-based compensation | ||||
| Amortization of right-of-use assets | ||||
| Interest income received on short-term investments | ) | ) | ||
| Unrealized foreign exchange loss | ||||
| Inventory write-down | ||||
| Payments on lease obligations | ) | ) | ||
| Changes in non-cash working capital: | ||||
| Inventories | ||||
| Prepaids and other assets | ||||
| Other non-current assets | ||||
| Accounts receivable | ) | |||
| Accounts payable and accrued liabilities | ) | ) | ||
| Deferred revenue | ||||
| Total cash used in operating activities | ) | ) | ||
| Investing Activities | ||||
| Short-term loan | ) | |||
| Total cash used in investing activities | ) | |||
| Financing Activities | ||||
| Shares issued for cash | ||||
| Share issuance costs | ) | ) | ||
| Total cash provided by financing activities | ||||
| Increase (decrease) in cash during the period | ||||
| Cash and cash equivalents beginning of the period | ||||
| Cash and cash equivalents end of the period |
All values are in US Dollars.
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**About InMed:**InMed Pharmaceuticals is a global leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, 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 www.baymedica.com.
Investor Contact:
Colin Clancy
Vice President, Investor Relations
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: continuing to strengthen the pharmaceutical pipeline in dermatology, ocular and neurodegenerative diseases; continuing to screen a library of proprietary analogs for additional therapeutic candidates; expecting many milestones in the clinical and preclinical programs; evaluating the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms; the completion of Phase 2 clinical trial in epidermolysis bullosa during calendar year 2022; advancing the glaucoma program towards human trials; CBN being the cannabinoid of choice for neuroprotection and lowering intraocular pressure in glaucoma and potentially other ocular diseases; advancing discovery work to identify an appropriate compound for a preclinical development program for treating neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s disease and Huntington’s disease; the generation of proprietary cannabinoid analogs to support the Company’s pharmaceutical drug development programs; BayMedica exploring potential opportunities for structured supply agreements, commercial collaborations and review other strategic alternatives for the commercial aspect of its business; the Company’s current cash reserves are estimated to last into the second half of fiscal 2023, and possibly into the first quarter of fiscal 2024.
With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions. 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. 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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