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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 29, 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.
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
September 29, 2023, the Company reported financial results for the fiscal year ended June 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:
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 29, 2023 |
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 Reports
Full Year Fiscal 2023 Financial Results and Provides Business Update
| ● | Completed Phase 2 Clinical Trial demonstrating anti-itch activity of INM-755
(CBN) topical cream |
| ● | $4.1M revenues in fiscal year 2023, representing a 280% increase over
the previous fiscal year and $2.3M revenues in fiscal Q4 2023, representing 123% increase quarter over quarter (“QoQ”) |
| | |
| ● | Strengthens pharmaceutical pipeline with launch of INM-900 series program
targeting neurodegenerative diseases such as Alzheimer’s |
Vancouver, BC –
September 29, 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 announced financial results for the fiscal year ending June 30, 2023 and provided a business update on the pharmaceutical drug development
programs as well as the commercial segment for a wholly-owned subsidiary, BayMedica, LLC (“BayMedica”).
The Company’s
full financial statements and related MD&A for the fiscal year ended June 30, 2023, are available at www.inmedpharma.com and
at www.sedar.com.
Financial and operating
highlights for fiscal 2023:
| ● | Total sales for subsidiary BayMedica of rare
cannabinoids in the health and wellness sector of $4.1M in fiscal year 2023, representing a 280% increase over the previous fiscal year
and $2.3M in revenue for the three months ended June 30, 2023, a 123% increase QoQ; |
| ● | As of June 30, 2023, the Company’s cash,
cash equivalents and short-term investments were $9.0M; |
| ● | For the year ended June 30, 2023, the Company
recorded a net loss of $7.9M, compared with a net loss of $18.6M for the previous year; |
| ● | Completed Phase 2 clinical trial in the treatment
of Epidermolysis Bullosa (“EB”); |
| ● | Launched INM-900 series preclinical program targeting
the treatment of neuro-degenerative diseases such as Alzheimer’s, Huntington’s and Parkinson’s disease; and |
| ● | Published a peer-reviewed study showing the anti-inflammatory
potential of rare cannabinoids in skin conditions. |
Eric A. Adams, InMed
Chief Executive Officer commented, “In fiscal year 2023, the Company’s wholly-owned subsidiary, BayMedica, achieved substantial
revenue growth via the supply of rare cannabinoids as ingredients to the health and wellness sector. In the January to June timeframe,
BayMedica experienced substantial growth, as evidenced by two consecutive quarters of significant revenue increases. While we expect some
fluctuations in revenue as ordering patterns in this developing market still mature, we remain optimistic about the long-term growth potential
in the rare cannabinoids sector as the business dynamics and commercial opportunities continue to mature. Additionally, we continue to
advance our pharmaceutical pipeline using rare cannabinoids for potential therapeutic applications in dermatology, ocular and neurodegenerative
disease.”
Adams continued, “Results
from the Phase 2 clinical trial in the treatment of symptom related to EB demonstrated sufficient clinically important anti-itch activity
to warrant further development. We are now seeking strategic partnership opportunities to further advance INM-755 in EB and other anti-itch
indications with larger commercial opportunities. Progress in both our ocular and neurodegenerative disease programs highlights our commitment
to advancing our pharmaceutical pipeline, with a particular emphasis on advancing our library of proprietary cannabinoid analogs.”
Business Update
Pharmaceutical Development
Programs
Dermatology Program
– Phase 2 Clinical Trial Complete
In the fourth quarter,
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. Of the 18 participants assessed in this trial, chronic itch improved by a clinically meaningful amount
in 12 patients (66.7%) of whom 5 patients (27.8%) treated with INM-755 showed meaningful anti-itch activity beyond that of the control
cream. 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. That the majority of the assessed patients in the trial showed clinically meaningful improvement in chronic itch from the application
of INM-755, be it with similar outcomes to the control cream or better than the control cream, can be considered impressive. We are encouraged
by and satisfied with the INM-755 clinical data for chronic itch treatment. The results indicate that continue development as an anti-itch
product is warranted. Please see press release dated June 22, 2023, for full details.
Based on the safety
and efficacy data for treating non-wound itch in this EB study, as well as previous safety data from Phase 1 trials, we believe there
is sufficient data to warrant its further development as an anti-itch therapy in patients with EB or other diseases. 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. InMed has engaged the services of an external business development
consultant to assess potential partnership opportunities for the advancement of INM-755.
Ocular Programs
– Advancing treatment for both front and back of eye diseases
The Company continued
to advance INM-088 in the treatment of glaucoma, conducting IND-enabling preclinical testing for the development of a CBN-based eye drop
formulation.
Establishing the role
of certain cannabinoids in neuroprotection of the eye led to the investigation of our proprietary cannabinoid analogs as a potential treatment
for other ocular diseases including Age-Related Macular Degeneration (“AMD”), who’s affected populations are much larger
than glaucoma. We are currently screening our library of proprietary analog candidates for continued research and will provide further
updates in the near term.
Neurodegenerative
diseases program – Promising proprietary cannabinoid analogs
In November 2022, InMed
launched the INM-900 series program targeting the use of proprietary cannabinoid analogs to treat neurodegenerative diseases such as Alzheimer’s,
Huntington’s and Parkinson’s. InMed’s ocular neuroprotection research led to investigation as to how cannabinoids might
play a role in protecting other neurons in the human body from cell death and potentially impacting different diseases.
Cannabinoids have two
inherent advantages when assessing their potential to treat diseases in the brain. First, they are highly lipophilic compounds (readily
dissolve in fats, oils and lipids) that can effectively cross the blood-brain barrier in meaningful concentrations, which is traditionally
a challenge in drug development. Second, they have proven to be relatively safe compounds in the brain, whereas several currently approved
treatments for neurodegenerative diseases can cause inflammation and bleeding in the brain. InMed’s research thus far demonstrates
that certain cannabinoid analogs may inhibit or slow the progression of neurodegenerative diseases by providing neuroprotection in a population
of affected neurons.
To date, InMed has
identified two cannabinoid analogs (INM-900 series of compounds) demonstrating promising effects related to the treatment of neurodegenerative
diseases. Candidate selection and further preclinical in vivo readout is expected in the near term.
BayMedica Commercial
Subsidiary
BayMedica, a leading supplier of non-intoxicating
rare cannabinoids to the health and wellness sector, has experienced strong revenue growth during the fiscal year 2023, reaching $4.1M,
representing a 280% increase over the previous year. Notably, BayMedica has achieved three consecutive quarters of substantial revenue
growth, with Q2, Q3, and Q4 2023 seeing increases of 46%, 100%, and 123%, respectively. While we expect revenue fluctuations based on
distributor order patterns, there are no assurances that this growth will continue in future quarters. However, the recent trend of increased
sales is encouraging. Over the last 12 months, BayMedica has optimized and scaled up manufacturing processes to meet increasing demand, secured
more sources of raw materials as well as secured additional downstream purification partners in order to provide customers with high-purity
rare cannabinoids with minimal batch-to-batch variations.
Although there are
no assurances this growth will continue in future quarters, this recent trend is encouraging. BayMedica will continue to evaluate opportunities
for potential structured supply arrangements and collaborations for the commercial business. 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, 2023, the
Company recorded a net loss of $7.9M, or $3.25 per share, compared with a net loss of $18.6M or $33.17 per share, for the previous year.
Research and development and patents expenses
were $3.7M for year ended June 30, 2023, compared with $7.3M for the year ended June 30, 2022. Expenses decreased by $3.1M in our InMed
segment, or 52%, for the year ended June 30, 2023 compared to the year ended June 30, 2022. The decrease in research and development and
patents expenses was due to a combination of lower personnel expenses, legal fees and decreased expenses related to the INM-755 program
as a result of high start-up costs associated with the multicentre Phase 2 clinical trial during fiscal 2022.
The Company incurred general and administrative
expenses of $5.8M for the year ended June 30, 2023, compared to $6.9M in the previous year. The decrease was primarily from a combination
of changes in the InMed segment, including lower office and admin fees, investor relation expenses, stock-based compensation expenses,
personnel expenses, accounting, and legal fees. This was offset by a slight increase in the BayMedica segment.
The Company realized sales of $4.1M
in our BayMedica segment for the year ended June 30, 2023, representing a 280% increase over the previous year. BayMedica realized three
consecutive quarters of significant revenue growth, with increases of 46%, 100%, and 123% in Q2, Q3, and Q4 2023, respectively.
As of June 30, 2023, the Company’s
cash, cash equivalents and short-term investments were $9.0M. The Company expects its cash will be sufficient to fund its planned operating
expenses and capital expenditure requirements into the first quarter of calendar year 2024, depending on the level and timing of realizing
BayMedica revenues from the sale of non-intoxicating rare cannabinoids in the health and wellness sector as well as the level and timing
of the Company’s operating expenses.
Table 1. Consolidated Balance Sheet
Expressed in U.S. Dollars
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | |
ASSETS | |
$ | | |
$ | |
Current | |
| | |
| |
Cash and cash equivalents | |
| 8,912,517 | | |
| 6,176,866 | |
Short-term investments | |
| 44,422 | | |
| 44,804 | |
Accounts receivable, net | |
| 260,399 | | |
| 88,027 | |
Inventories | |
| 1,616,356 | | |
| 2,490,854 | |
Prepaids and other current assets | |
| 498,033 | | |
| 797,225 | |
Total current assets | |
| 11,331,727 | | |
| 9,597,776 | |
| |
| | | |
| | |
Non-Current | |
| | | |
| | |
Property, equipment and ROU assets, net | |
| 723,426 | | |
| 904,252 | |
Intangible assets, net | |
| 1,946,279 | | |
| 2,108,915 | |
Other assets | |
| 104,908 | | |
| 176,637 | |
Total Assets | |
| 14,106,340 | | |
| 12,787,580 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Current | |
| | | |
| | |
Accounts payable and accrued liabilities | |
| 1,608,735 | | |
| 2,415,265 | |
Current portion of lease obligations | |
| 375,713 | | |
| 404,276 | |
Deferred rent | |
| 16,171 | | |
| - | |
Acquisition consideration payable | |
| - | | |
| 500,000 | |
Total current liabilities | |
| 2,000,619 | | |
| 3,319,541 | |
| |
| | | |
| | |
Non-current | |
| | | |
| | |
Lease obligations, net of current portion | |
| 15,994 | | |
| 389,498 | |
Total Liabilities | |
| 2,016,613 | | |
| 3,709,039 | |
Commitments and Contingencies (Note 14) | |
| | | |
| | |
| |
| | | |
| | |
Shareholders’ Equity | |
| | | |
| | |
Common shares, no par value, unlimited authorized shares: 3,328,191 (June 30, 2022 - 650,667) issued and outstanding | |
| 77,620,252 | | |
| 70,718,461 | |
Additional paid-in capital | |
| 35,741,115 | | |
| 31,684,098 | |
Accumulated deficit | |
| (101,400,209 | ) | |
| (93,452,587 | ) |
Accumulated other comprehensive income | |
| 128,569 | | |
| 128,569 | |
Total Shareholders’ Equity | |
| 12,089,727 | | |
| 9,078,541 | |
Total Liabilities and Shareholders’ Equity | |
| 14,106,340 | | |
| 12,787,580 | |
Related Party Transactions (Note 15) | |
| | | |
| | |
Subsequent Events (Note 16) | |
| | | |
| | |
Table 2. Consolidate Statements of Operations
Expressed in U.S. Dollars
| |
For the Years Ended | |
| |
June 30 | |
| |
2023 | | |
2022 | |
| |
$ | | |
$ | |
| |
| | |
| |
Sales | |
| 4,135,561 | | |
| 1,089,435 | |
Cost of sales | |
| 2,423,588 | | |
| 545,889 | |
Inventory write-down | |
| 308,937 | | |
| - | |
Gross profit | |
| 1,403,036 | | |
| 543,546 | |
| |
| | | |
| | |
Operating Expenses | |
| | | |
| | |
Research and development and patents | |
| 3,732,056 | | |
| 7,282,615 | |
General and administrative | |
| 5,847,518 | | |
| 6,867,030 | |
Amortization and depreciation | |
| 202,249 | | |
| 185,657 | |
Impairment of intangible assets and goodwill | |
| - | | |
| 3,472,593 | |
Total operating expenses | |
| 9,781,823 | | |
| 17,807,895 | |
| |
| | | |
| | |
Other Income (Expense) | |
| | | |
| | |
Interest and other income | |
| 492,440 | | |
| 96,090 | |
Warrant modification expense | |
| - | | |
| (1,314,307 | ) |
Foreign exchange loss | |
| (48,175 | ) | |
| (117,551 | ) |
Loss before income tax expense | |
| (7,934,522 | ) | |
| (18,600,117 | ) |
| |
| | | |
| | |
Income tax expense | |
| (13,100 | ) | |
| - | |
Net loss for the year | |
| (7,947,622 | ) | |
| (18,600,117 | ) |
| |
| | | |
| | |
Net loss per share for the year | |
| | | |
| | |
Basic and diluted | |
| (3.25 | ) | |
| (33.17 | ) |
Weighted average outstanding common shares | |
| | | |
| | |
Basic and diluted | |
| 2,448,458 | | |
| 560,829 | |
Table 3. Consolidated Statements of CashFlows
Expressed in U.S. Dollars
| |
2023 | | |
2022 | |
| |
$ | | |
$ | |
Cash provided by (used in): | |
| | |
| |
| |
| | |
| |
Operating Activities | |
| | |
| |
Net loss | |
| (7,947,622 | ) | |
| (18,600,117 | ) |
Items not requiring cash: | |
| | | |
| | |
Amortization and depreciation | |
| 202,249 | | |
| 185,657 | |
Share-based compensation | |
| 278,155 | | |
| 697,894 | |
Shares issued for services | |
| - | | |
| 79,879 | |
Amortization of right-of-use assets | |
| 393,748 | | |
| 326,133 | |
Loss on disposal of assets | |
| - | | |
| 11,355 | |
Interest income received on short-term investments | |
| (803 | ) | |
| (115 | ) |
Unrealized foreign exchange loss | |
| 1,183 | | |
| 1,770 | |
Impairment of intangible assets and goodwill | |
| - | | |
| 3,472,593 | |
Inventory write-down | |
| 308,937 | | |
| - | |
Bad debts | |
| 46,775 | | |
| - | |
Warrant modification expense | |
| - | | |
| 1,314,307 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Inventories | |
| 565,561 | | |
| (2,003,732 | ) |
Prepaids and other currents assets | |
| 299,192 | | |
| 190,661 | |
Other non-current assets | |
| 5,507 | | |
| (61,432 | ) |
Accounts receivable | |
| (219,147 | ) | |
| (40,008 | ) |
Accounts payable and accrued liabilities | |
| (806,530 | ) | |
| (811,599 | ) |
Deferred rent | |
| 16,171 | | |
| (5,142 | ) |
Lease obligations | |
| (426,575 | ) | |
| (341,862 | ) |
Total cash used in operating activities | |
| (7,283,199 | ) | |
| (15,583,758 | ) |
| |
| | | |
| | |
Investing Activities | |
| | | |
| | |
Cash acquired from acquisition of BayMedica | |
| - | | |
| 91,566 | |
Payment of acquisition consideration payable | |
| (500,000 | ) | |
| (300,457 | ) |
Payment of deposit on equipment | |
| (1,790 | ) | |
| - | |
Purchase of property and equipment | |
| (160,014 | ) | |
| (39,108 | ) |
Sale of short-term investments | |
| (42,268 | ) | |
| - | |
Purchase of short-term investments | |
| 42,268 | | |
| - | |
Loan receivable | |
| - | | |
| (425,000 | ) |
Total cash (used in) provided by investing activities | |
| (661,804 | ) | |
| (672,999 | ) |
| |
| | | |
| | |
Financing Activities | |
| | | |
| | |
Shares issued for cash | |
| 12,000,436 | | |
| 17,146,114 | |
Share issuance costs | |
| (1,319,782 | ) | |
| (1,784,791 | ) |
Repayment of debt | |
| - | | |
| (290,826 | ) |
Total cash provided by financing activities | |
| 10,680,654 | | |
| 15,070,497 | |
Increase (decrease) in cash during the period | |
| 2,735,651 | | |
| (1,186,260 | ) |
Cash and cash equivalents beginning of the period | |
| 6,176,866 | | |
| 7,363,126 | |
Cash and cash equivalents end of the period | |
| 8,912,517 | | |
| 6,176,866 | |
| |
| | | |
| | |
SUPPLEMENTARY CASH FLOW INFORMATION: | |
| | | |
| | |
Cash Paid During the Year for: | |
| | | |
| | |
Income taxes | |
$ | - | | |
$ | - | |
Interest | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
SUPPLEMENTARY DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | |
| | | |
| | |
Preferred investment options to its placement agent | |
$ | 691,484 | | |
$ | 192,491 | |
Warrants to its placement agent | |
$ | - | | |
$ | 739,920 | |
Shares issued for acquisition | |
$ | - | | |
$ | 3,013,500 | |
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.
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; seeking strategic partnership opportunities to further advance INM-755 in EB and
other anti-itch indications; advancing our pharmaceutical pipeline, with a particular emphasis on advancing our library of proprietary
cannabinoid analogs; believing there is sufficient data to warrant its further development as an anti-itch therapy in patients with EB
or other diseases; development of the INM-755 CBN cream is expected to extend beyond its application in EB; analogs may inhibit or slow
the progression of neurodegenerative diseases by providing neuroprotection in a population of affected neurons; selecting a candidate
for the INM-900 program with further readout is expected in the near term; BayMedica being a leading supplier of non-intoxicating rare
cannabinoids to the health and wellness sector.
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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InMed Pharmaceuticals (NASDAQ:INM)
過去 株価チャート
から 5 2024 まで 6 2024
InMed Pharmaceuticals (NASDAQ:INM)
過去 株価チャート
から 6 2023 まで 6 2024