UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period
ended March 31, 2024
or
☐ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period
from __________ to __________
Commission File Number:
001-39685
INMED PHARMACEUTICALS
INC.
(Exact name of registrant
as specified in its charter)
British Columbia, Canada 98-1428279
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
Suite 310 - 815 W. Hastings Street ,
Vancouver , B.C .
Canada
V6C 1B4
(Address of Principal Executive Offices) (Zip Code)
(604) 669-7207
(Registrant’s telephone number, including
area code)
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
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
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. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Act): Yes ☐ No ☒
As of May 9, 2024, the registrant had
8,357,956 common shares, without par value, outstanding.
INDEX
Page
PART I – FINANCIAL INFORMATION
ITEM 1.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
23
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
36
ITEM 4. CONTROLS AND PROCEDURES
36
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
37
ITEM 1A. RISK FACTORS
37
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
37
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
37
ITEM 4. MINE SAFETY DISCLOSURE
37
ITEM 5. OTHER INFORMATION
37
ITEM 6. EXHIBITS
38
SIGNATURES
39
i
PART I
ITEM 1. CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS.
Unaudited Condensed Consolidated Financial
Statements of
InMed Pharmaceuticals Inc.
For the Three and Nine Months Ended March 31,
2024 and 2023
1
InMed Pharmaceuticals Inc.
(Expressed in U.S. Dollars)
March 31, 2024
INDEX
Page
Financial Statements (Unaudited)
●
Condensed Consolidated Balance
Sheets
3
●
Condensed Consolidated Statements of
Operations
4
●
Condensed Consolidated Statements of
Shareholders’ Equity
5
●
Condensed Consolidated Statements of
Cash Flows
6
●
Notes to the Condensed Consolidated
Financial Statements
7-19
2
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
Expressed in U.S. Dollars
March 31,
2024
June 30,
(unaudited)
2023
$
$
ASSETS
Current
Cash and cash equivalents
7,600,598
8,912,517
Short-term investments
43,085
44,422
Accounts receivable, net of allowance for credit losses of $ 66,775
in 2024 and 2023
207,681
260,399
Inventories
1,193,952
1,616,356
Prepaids and other current assets
1,018,686
498,033
Total current assets
10,064,002
11,331,727
Non-Current
Property, equipment and ROU assets, net
1,370,969
723,426
Intangible assets, net
1,823,745
1,946,279
Other assets
100,000
104,908
Total Assets
13,358,716
14,106,340
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
Accounts payable and accrued liabilities
1,183,285
1,608,735
Current portion of lease obligations
345,545
375,713
Deferred rent
-
16,171
Total current liabilities
1,528,830
2,000,619
Non-current
Lease obligations, net of current portion
725,236
15,994
Total Liabilities
2,254,066
2,016,613
Commitments and Contingencies (Note 11)
Shareholders’ Equity
Common shares, no par value, unlimited authorized shares:
6,344,970 (June 30, 2023 - 3,328,191 ) issued and outstanding
80,606,863
77,620,252
Additional paid-in capital
37,507,306
35,741,115
Accumulated deficit
( 107,138,088 )
( 101,400,209 )
Accumulated other comprehensive income
128,569
128,569
Total Shareholders’ Equity
11,104,650
12,089,727
Total Liabilities and Shareholders’ Equity
13,358,716
14,106,340
Related Party Transactions (Note 12)
Subsequent Events (Note 13)
The accompanying notes form an integral part of
these condensed consolidated financial statements.
3
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
Expressed in U.S. Dollars
For the Three Months Ended
For the Nine Months Ended
March 31
March 31
2024
2023
2024
2023
$
$
$
$
Sales
1,172,601
1,033,925
3,314,663
1,824,496
Cost of sales
883,143
841,414
2,416,417
1,415,068
Inventory write-down
-
-
263,404
576,772
Gross profit
289,458
192,511
634,842
( 167,344 )
Operating Expenses
Research and development and patents
656,764
878,303
2,558,648
3,108,312
General and administrative
1,374,095
1,412,727
4,036,784
4,438,083
Amortization and depreciation
54,767
50,689
164,833
148,786
Foreign exchange loss
48,156
2,733
36,717
79,287
Total operating expenses
2,133,782
2,344,452
6,796,982
7,774,468
Other Income (Expense)
Interest and other income
121,458
155,497
424,261
343,881
Loss before income taxes
( 1,722,866 )
( 1,996,444 )
( 5,737,879 )
( 7,597,931 )
Tax expense
-
( 1,500 )
-
( 11,300 )
Net loss for the period
( 1,722,866 )
( 1,997,944 )
( 5,737,879 )
( 7,609,231 )
Net loss per share for the period
Basic and diluted
( 0.18 )
( 0.60 )
( 0.82 )
( 3.53 )
Weighted average outstanding common shares
Basic and diluted
9,612,973
3,328,191
6,961,938
2,156,283
The accompanying notes form an integral part of
these condensed consolidated financial statements.
4
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY FOR
THE THREE AND NINE MONTHS ENDED MARCH 31, 2024 AND 2023 (unaudited)
Expressed in U.S. Dollars
Additional
Accumulated
Other
Common Shares
Paid-in
Capital
Accumulated
Deficit
Comprehensive
Income
Total
#
$
$
$
$
$
Balance June 30, 2023
3,328,191
77,620,252
35,741,115
( 101,400,209 )
128,569
12,089,727
Loss for the period
-
-
-
( 2,536,828 )
-
( 2,536,828 )
Share-based compensation
-
-
25,191
-
-
25,191
Balance September 30, 2023
3,328,191
77,620,252
35,766,306
( 103,937,037 )
128,569
9,578,090
Proceeds from private placement net of issuance costs
2,339,779
2,316,381
2,337,661
-
-
4,654,042
Loss for the period
-
-
-
( 1,478,185 )
-
( 1,478,185 )
Share-based compensation
-
-
18,264
-
-
18,264
Balance December 31, 2023
5,667,970
79,936,633
38,122,231
( 105,415,222 )
128,569
12,772,211
Proceeds from private placement net insurance costs
677,000
670,230
( 670,230 )
-
-
-
Loss for the period
-
( 1,722,866 )
-
( 1,722,866 )
Share-based compensation
-
-
55,305
-
-
55,305
Balance March 31, 2024
6,344,970
80,606,863
37,507,306
( 107,138,088 )
128,569
11,104,650
Additional
Accumulated
Other
Common Shares
Paid-in
Capital
Accumulated
Deficit
Comprehensive
Income
Total
#
$
$
$
$
$
Balance June 30, 2022
650,667
70,718,461
31,684,098
( 93,452,587 )
128,569
9,078,541
Proceeds from private placement net of issuance costs
90,000
333,134
4,989,366
-
-
5,322,500
Exercise of pre-funded warrants
168,099
1,619,797
( 1,619,378 )
-
-
419
Loss for the period
-
-
-
( 3,510,200 )
-
( 3,510,200 )
Share-based compensation
-
-
116,680
-
-
116,680
Balance September 30, 2022
908,766
72,671,392
35,170,766
( 96,962,787 )
128,569
11,007,940
Proceeds from private placement net of issuance costs
150,000
224,659
5,132,848
-
-
5,357,507
Exercise of pre-funded warrants
531,226
1,966,373
( 1,966,320 )
-
-
53
Loss for the period
-
-
-
( 2,101,087 )
-
( 2,101,087 )
Share-based compensation
-
-
70,638
-
-
70,638
Balance December 31, 2022
1,589,992
74,862,424
38,407,932
( 99,063,874 )
128,569
14,335,051
Exercise of pre-funded warrants
1,738,199
2,757,828
( 2,757,654 )
-
-
174
Loss for the period
-
-
-
( 1,997,944 )
-
( 1,997,944 )
Share-based compensation
-
-
50,357
-
-
50,357
Balance March 31, 2023
3,328,191
77,620,252
35,700,635
( 101,061,818 )
128,569
12,387,638
The accompanying notes form an integral part of
these condensed consolidated financial statements.
5
InMed Pharmaceuticals Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
Expressed in U.S. Dollars
March
31,
2024
March
31,
2023
$
$
Cash provided by (used in):
Operating Activities
Net
loss
( 5,737,879 )
( 7,609,231 )
Items
not requiring cash:
Amortization
and depreciation
164,833
148,786
Share-based
compensation
98,760
237,675
Amortization
of right-of-use assets
287,824
296,239
Interest
income on short-term investments
( 1,271 )
( 392 )
Unrealized
foreign exchange loss
2,607
2,138
Inventory
write-down
263,404
576,772
Bad
debts
-
25,085
Changes
in operating assets and liabilities:
Inventories
159,000
584,151
Prepaids
and other current assets
( 520,653 )
102,022
Other
non-current assets
4,908
5,507
Accounts
receivable
52,718
( 107,357 )
Accounts
payable and accrued liabilities
( 425,446 )
( 585,341 )
Deferred
rent
( 16,171 )
16,171
Lease
obligations
( 289,302 )
( 317,490 )
Total
cash used in operating activities
( 5,956,668 )
( 6,625,265 )
Investing
Activities
Payment
of acquisition consideration
-
( 500,000 )
Sale
of short-term investments
42,513
-
Purchase
of short-term investments
( 42,513 )
-
Purchase
of property and equipment
( 9,293 )
( 128198 )
Total
cash used in investing activities
( 9,293 )
( 628,198 )
Financing
Activities
Proceeds
from private placement
4,654,042
10,680,654
Total
cash provided by financing activities
4,654,042
10,680,654
(Decrease)
increase in cash and cash equivalents during the period
( 1,311,919 )
3,427,191
Cash
and cash equivalents beginning of the period
8,912,517
6,176,866
Cash
and cash equivalents end of the period
7,600,598
9,604,057
SUPPLEMENTARY
CASH FLOW INFORMATION:
Cash
Paid During the Year for:
Income
taxes
$ -
$ 11,300
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
$ -
The accompanying notes form an integral part of
these condensed consolidated financial statements.
6
InMed Pharmaceuticals Inc.
Notes to the Condensed Consolidated
Financial Statements
1.
CORPORATE INFORMATION
AND CONTINUING OPERATIONS
Business
InMed Pharmaceuticals
Inc. (“InMed” or the “Company”) was incorporated in the Province of British Columbia on May 19, 1981 under the
Business Corporations Act of British Columbia. InMed is a clinical stage pharmaceutical company developing a pipeline of proprietary
small molecule drug candidates, targeting the treatment of diseases with high unmet medical needs as well as developing proprietary manufacturing
technologies to produce bulk rare cannabinoids for sale as ingredients in the health and wellness industry.
The Company’s
shares are listed on the Nasdaq Capital Market (“Nasdaq”) under the trading symbol “INM”. InMed’s office
and principal place of business is located at #310 – 815 West Hastings Street, Vancouver, B.C., Canada, V6C 1B4.
Going Concern
In accordance
with the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-15, Disclosure
of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether
there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue
as a going concern within one year after the date that the consolidated financial statements are issued.
Through March
31, 2024, the Company has funded its operations primarily with proceeds from the sale of common stock. The Company has incurred recurring
losses and negative cash flows from operations since its inception, including net losses of approximately $ 5.7 million and $ 7.6 million
for the nine months ended March, 2024 and 2023, respectively. In addition, the Company had an accumulated deficit of approximately $ 107.1
million as of March 31, 2024. The Company expects to continue to generate operating losses for the foreseeable future.
As of the issuance
date of these condensed consolidated financial statements, the Company expects its cash, cash equivalents and short-term investments of
$ 7.6 million as of March 31, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth
quarter of calendar 2024, depending on the level and timing of realizing BayMedica, LLC, a wholly-owned subsidiary of the Company (“BayMedica”),
revenues from the sale of bulk rare cannabinoids as ingredients in the health and wellness sector as well as the level and timing of the
Company’s operating expenses. The future viability of the Company is dependent on its ability to raise additional capital to finance
its operations. The Company has concluded that there is substantial doubt about its ability to continue as a going concern within one
year after the date that the condensed consolidated financial statements are issued.
The Company expects
to continue to seek additional funding through equity financings, debt financings or other capital sources, including collaborations with
other companies, government contracts or other strategic transactions. The Company may not be able to obtain financing on acceptable terms,
or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s existing shareholders.
In
connection with the Company’s assessment of going concern considerations in accordance with Subtopic 205-40, management has
determined that the Company’s liquidity condition raises substantial doubt about the Company’s ability to continue as a
going concern, which is considered to be for a period of one year from the issuance of these financial statements. These condensed
consolidated financial statements do not include any adjustments relating to recoverability and classification of recorded asset
amounts or the amounts of classification of liabilities that might result from the outcome of this uncertainty. Such adjustments
could be material.
7
2.
SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
These unaudited condensed
consolidated financial statements have been prepared in accordance with generally accepted accounting principles as applied in the United
States (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”)
for financial information. Accordingly, these financial statements do not include all the information and footnotes required for complete
financial statements and should be read in conjunction with the audited consolidated financial statements of the Company and the accompanying
notes thereto for the fiscal year ended June 30, 2023.
These condensed consolidated
financial statements reflect all adjustments, consisting solely of normal recurring adjustments, which, in the opinion of management,
are necessary for a fair presentation of results for the interim periods presented. The results of operations for the three months and
nine months ended March 31, 2024 and 2023 are not necessarily indicative of results that can be expected for a full year. These condensed
consolidated financial statements follow the same significant accounting policies as those described in the notes to the audited consolidated
financial statements of the Company for the fiscal year ended June 30, 2023.
Reclassifications
Certain prior year
amounts in the condensed consolidated financial statements and the notes thereto have been reclassified where necessary to conform to
the current year’s presentation. These reclassifications did not affect the prior period’s total assets, total liabilities,
stockholders’ deficit, net loss or net cash used in operating activities. During the three months and nine months ended March 31,
2024, we adopted a change in presentation on our condensed consolidated statements of operations in order to include foreign exchange
loss in operating expenses. The Company has adopted ASU 2023-07 - Improvements to Reportable Segment Disclosures which has required
prior period to reflect the change in presentation. Refer to discussion on Recent Accounting Pronouncements below.
Use of Estimates
The preparation of financial statements in compliance with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amount of assets and liabilities as of the balance sheet date, and
the corresponding revenues and expenses for the periods reported. It also requires management to exercise judgment in applying the Company’s
accounting policies. In the future, actual experience may differ from these estimates and assumptions. The areas involving a higher degree
of judgment or complexity, or areas where assumptions and estimates are significant to these condensed consolidated financial statements
are the application of the going concern assumption, and determining the fair value of share-based payments, income tax provisions, write-down
of inventories to net realizable value, and warrant valuations.
Actual results
could differ from those estimates.
8
Basis of Consolidation
These condensed consolidated
financial statements include the accounts of the Company and its subsidiaries, including subsidiaries: InMed Pharmaceutical Ltd., BayMedica,
LLC, Biogen Sciences Inc., and Sweetnam Consulting Inc. A subsidiary is an entity that the Company controls, either directly or indirectly,
where control is defined as the power to govern the financial and operating policies of an entity so as to obtain benefits from its activities.
All inter-company transactions and balances including unrealized income and expenses arising from intercompany transactions are eliminated
in preparing these condensed consolidated financial statements.
Foreign Currency
The functional currency
of the Company and its subsidiaries is the U.S. Dollar. These consolidated financial statements are presented in U.S. Dollars. References
to “$” and “US$” are to United States (“U.S.”) dollars and references to “C$” are to Canadian
dollars.
Accounts Receivable
Accounts receivable
are recorded at invoiced amounts, net of any allowance for credit losses. The allowance for credit losses is the Company’s best
estimate of the amount of probable credit losses in existing accounts receivable.
The Company evaluates
the collectability of accounts receivable on a regular basis based upon various factors including the financial condition and payment
history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect
future collections experience.
Inventories
Inventories are initially
valued at weighted average cost and subsequently valued at the lower of weighted average cost and net realizable value. Costs included
in inventories are the purchase price of goods and cost of services rendered, freight costs, warehousing costs, purchasing costs and production
and labor costs related to manufacturing.
Cost of Sales
Cost of sales consists
primarily of the purchase price of goods and cost of services rendered, freight costs, warehousing costs, and purchasing costs. Cost of
sales also includes production and labor costs for the Company’s manufacturing business.
Concentration of Credit Risk and
Other Risks and Uncertainties
At times, the Company’s
cash balances may exceed the Federal Deposit Insurance Corporation (“FDIC”) or Canadian Deposit Insurance Corporation (“CDIC”)
insurable limits. To date, the Company has not experienced any losses related to these balances. The uninsured cash balance as of March
31, 2024 and June 30, 2023, was $ 3.0 million and $ 3.8 million respectively.
9
The Company’s
customers are primarily concentrated in the U.S.
As of March 31, 2024, the Company had four customers with an accounts
receivable balance representing 39 %, 32 %, 16 %, and 10 % of total accounts receivable, respectively. As of June 30, 2023, we had three customers
with an accounts receivable balance representing 41 %, 30 % and 15 % of total accounts receivable, respectively.
For the three months ended March 31, 2024, the Company had four customers
that accounted for 29 %, 21 %, 16 % and 16 % of revenue, respectively. For the three months ended March 31, 2023, the Company had four customers
that accounted for 22 %, 20 %, 17 % and 11 % of revenue, respectively.
For the nine
months ended March 31, 2024, the Company had four customers that accounted for 39 %, 16 %, 15 % and 10 % of revenue, respectively. For the
nine months ended March 31, 2023, the Company had four customers that accounted for 17 %, 15 %, 14 %, and 10 % of revenue, respectively.
This change is reflective of the Company’s transition to operating primarily through a distributor model in the year ended June
30, 2023.
Financial Assets and Liabilities
Financial Assets
Financial assets
are initially recognized at fair value, plus transaction costs that are directly attributable to their acquisition or issue and subsequently
carried at amortized cost, using the effective interest rate method, less any impairment losses. No financial assets are or elected to
be carried at fair value through profit or loss or where changes in fair value are recognized in the consolidated statements of operations
and comprehensive loss in other comprehensive loss.
Short-term investments
are subsequently recorded at cost plus accrued interest, which approximates fair value due to short term nature. Accounts receivable
are reported at outstanding amounts, net of provisions for uncollectable amounts.
Financial Liabilities
To determine
the fair value of financial instruments, the Company uses the fair value hierarchy for inputs used to measure the fair value of financial
assets and liabilities. This hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels: Level
1 (highest priority), Level 2, and Level 3 (lowest priority).
Level 1 –
Unadjusted quoted prices
in active markets for identical instruments.
Level 2 –
Inputs other than quoted
prices included within Level 1 are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted
prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets
that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield
curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means
(market corroborated inputs).
Level 3 –
Inputs are unobservable
and reflect the Company’s assumptions as to what market participants would use in pricing the asset or liability. The Company
develops these inputs based on the best information available. Assets and liabilities are classified based on the lowest level of
input that is significant to the fair value measurements. Changes in the observability of valuation inputs may result in a reclassification
of levels for certain securities within the fair value hierarchy.
The carrying
value of cash and cash equivalents, short-term investments, accounts receivable, and accounts payable and accrued liabilities, approximate
their carrying values as of March 31, 2024 and June 30, 2023 due to their immediate or short-term maturities.
10
Earnings (Loss) Per Share
Basic earnings
(loss) per common share (“EPS”) is computed by dividing the net income or loss applicable to common shares of the Company
by the weighted average number of common shares outstanding for the relevant period. The Company has 3,012,049 pre-funded warrants and
255,954 abeyance shares included in the basic earnings (loss) per share. Diluted earnings (loss) per common share (“Diluted EPS”)
is computed by dividing the net income or loss applicable to common shares by the sum of the weighted average number of common shares
issued and outstanding and all additional common shares that would have been outstanding for the three and nine months ended March 31,
2024, if potentially dilutive instruments were converted. If the conversion of outstanding stock options and warrants into common shares
is anti-dilutive, then diluted EPS is not presented separately from EPS.
The following
table sets forth the number of potential shares of common shares that have been excluded from diluted net income (loss) per because their
effect was anti-dilutive:
As of March 31,
2024
2023
Options
678,475
26,813
Warrants
13,204,093
3,528,643
13,882,568
3,555,456
Recent Accounting Pronouncements
The Company has
reviewed recent accounting pronouncements and concluded that they are either not applicable to the Company or that there was no material
impact or no material impact is expected in the consolidated financial statements as a result of future adoption.
In November 2023, the Financial Accounting Standards Board (“FASB”)
issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which enhances reportable segment disclosure
requirements primarily through expanded disclosures around significant segment expenses. The amendments are effective for fiscal years
beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. The amendments
should be applied retrospectively to all prior periods presented in the financial statements. The Company has early adopted this accounting
pronouncement.
In December 2023,
the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires disclosure of specific categories
meeting a quantitative threshold within the income tax rate reconciliation, as well as disaggregation of income taxes paid by jurisdiction.
This ASU, which can be applied either prospectively or retrospectively, is effective for annual periods beginning after December 15, 2024,
with early adoption permitted. The Company is currently evaluating the impact of the ASU and expects to include updated income tax disclosures.
3.
INVENTORIES
Inventories consisted
of the following:
March 31,
2024
June 30,
2023
Raw materials
$ 196,500
$ 208,737
Work in process
439,086
514,113
Finished goods
558,366
893,506
Inventories
$ 1,193,952
$ 1,616,356
In determining any valuation allowances, the Company reviews inventory
for obsolete, redundant, and slow-moving goods. As of March 31, 2024 and June 30, 2023, the Company has $ 357,224 and $ 93,820 respectively,
as a valuation allowance to reduce weighted average cost to net realizable value. During the three months ended March 31, 2024 and 2023,
the Company did not record an inventory write-down. During the nine months ended March 31, 2024 and 2023, the Company recorded an inventory
write-down of $ 263,404 and $ 576,772 , respectively.
11
4.
PROPERTY, EQUIPMENT
AND RIGHT OF USE (‘ROU’) ASSETS, NET
Property, equipment
and ROU assets consisted of the following:
March 31,
2024
June 30,
2023
Right-of-use assets (leases)
$ 2,135,811
$ 1,167,436
Equipment
429,090
440,902
Furnishing
40,409
40,409
Property and equipment
$ 2,605,310
$ 1,648,747
Less: accumulated depreciation and amortization
( 1,234,341 )
( 925,321 )
Property, equipment and ROU assets, net
$ 1,370,969
$ 723,426
Depreciation
expense on computer equipment, lab equipment and furnishing for the three months ended March 31, 2024 and 2023, was $ 14,220 and $ 10,586 ,
respectively, and was recorded in general and administrative expenses. Amortization expense related to the right-of-use assets for the
three months ended March 31, 2024 and 2023, was $ 95,615 and $ 91,935 , respectively, and was recorded in general and administrative expenses.
Depreciation expense on computer equipment, lab equipment and furnishing
for the nine months ended March 31, 2024 and 2023, was $ 42,302 and $ 26,697 , respectively, and was recorded in general and administrative
expenses. Amortization expense related to the right-of-use assets for the nine months ended March 31, 2024 and 2023, was $ 287,824 and
$ 296,239 , respectively, and was recorded in general and administrative expenses.
5.
INTANGIBLE ASSETS
The following
table summarizes the Companies intangible assets:
March 31,
2024
June 30,
2023
Intellectual property
$ 1,736,420
$ 1,736,420
Patents
1,191,000
1,191,000
Intangible assets
2,927,420
2,927,420
Less: accumulated amortization
( 1,103,675 )
( 981,141 )
Intangible assets, net
$ 1,823,745
$ 1,946,279
Acquired intellectual
property is recorded at cost and is amortized on a straight-line basis over 18 years. Acquired patents consist of patents related to
the development of small molecule drug candidates. This intangible asset is being amortized over an estimated useful life of 18 years.
As of March 31, 2024, the definite-lived intangible assets had a weighted average estimated remaining useful life of approximately 12
years.
Amortization
expense on intangible assets for the three months ended March 31, 2024 and 2023 was $ 40,993 and $ 40,103 , respectively. Amortization expense
on intangible assets for the nine months ended March 31, 2024 and 2023 was $ 122,531 and $ 122,089 , respectively.
The Company expects
amortization expense to be incurred over the next five years as follows:
Twelve months ending March 31,
2024
$ 158,935
2025
158,935
2026
158,935
2027
158,935
2028
158,935
Thereafter
1,029,070
Total
$ 1,823,745
12
6.
ACCOUNTS PAYABLE AND
ACCRUED LIABILITIES
Accounts payable
and accrued liabilities consist of the following:
March 31,
2024
June 30,
2023
Trade payables
$ 402,638
$ 544,179
Accrued research and development expenses
353,465
164,587
Inventory purchase accruals
54,629
-
Employee compensation, benefits and related accruals
205,030
542,305
Accrued general and administrative expenses
167,523
357,664
Accounts payable and accrued liabilities
$ 1,183,285
$ 1,608,735
7.
SHARE CAPITAL AND RESERVES
Authorized
As of March 31,
2024, the Company’s authorized share structure consisted of: (i) an unlimited number of common shares without par value; and (ii)
an unlimited number of preferred shares without par value. No preferred shares were issued and outstanding as of March 31, 2024 and June
30, 2023.
The Company may,
from time to time, issue preferred shares and may, at the time of issuance, determine the rights, preferences and limitations pertaining
to these shares. Holders of preferred shares may be entitled to receive a preference payment in the event of any liquidation, dissolution
or winding up of the Company before any payment is made to the holders of common shares.
On October 24, 2023, the Company entered into a securities purchase
agreement (the “2023 Securities Purchase Agreement”) with two accredited institutional investors (the “Accredited Institutional
Investors”) for the sale (the “2023 Private Placement”) of 3,012,049 pre-funded warrants of the Company’s common
shares at a purchase price of $ 0.83 per share. The pre-funded warrants have an exercise price of $ 0.0001 and do not have an expiration
date. The pre-funded warrants had a fair value of $ 1,248,376 at the time of issuance. In addition, the Company agreed, as part of the
2023 Private Placement, to issue to the purchasers unregistered preferred investment options to purchase up to an aggregate of 3,012,049
common shares. These preferred investment options have an exercise price of $ 0.83 and have a term of 5.5 years from issuance. The preferred
investment options had a fair value of $ 1,251,449 at the time of their issuance. Subsequent to their issuance, the preferred investment
options were registered with the SEC on Form S-1 on November 8, 2023, which became effective on November 13, 2023. Subsequent to March
31, 2024, an Accredited Institutional Investor exercised 1,757,032 preferred investment options.
Concurrently
with the Company’s entry into the 2023 Securities Purchase Agreement, the Company also entered into an inducement offer letter
agreement (the “Inducement Offer Letter”) with the holders of existing preferred investment options (the “Existing
Holders”) to purchase up to an aggregate of 3,272,733 common shares issued to the Existing Holders on November 21, 2022. Pursuant
to the Inducement Offer Letter, the Existing Holders agreed to exercise for cash their existing preferred investment options to purchase
an aggregate of 3,272,733 common shares (at a reduced exercise price of $ 0.83 per share) in consideration of the Company’s agreement
to issue new unregistered preferred investment options to purchase up to an aggregate of 6,545,466 shares of the Company’s common
shares at an exercise price of $ 0.83 per share). Due to ownership limitations, the Accredited Institutional Investors had 1,796,552 common
shares held in abeyance as of the closing of the 2023 Private Placement. The abeyance shares had a fair value of $ 1,491,138 and the common
shares issued had a fair value of $ 1,225,230 on their respective issuance date. As of March 31, 2024, the Accredited Institutional Investors
had drawn down 1,540,598 abeyance shares. Subsequent to March 31, 2024, the Accredited Institutional Investors drew down the remaining
255,954 abeyance shares.
The inducement
contemplated by the Inducement Offer Letter (the “Inducement”) is considered a warrant modification due to the changing of
the terms of the warrants. The modification had a fair value of $ 3.5 million as of the date of the Inducement, using a Black-Scholes
model and is recognized as an equity issuance cost in accordance with ASC 718-20-35-3.
On October 26,
2023, the parties consummated the 2023 Private Placement and the other transactions contemplated by the 2023 Securities Purchase Agreement.
In connection with such transactions, the Company (i) received gross proceeds of approximately $ 5.2 million and paid approximately $ 560,000
in cash fees and (ii) issued 408,511 warrants to our placement agent. These warrants have an exercise price of $ 1.0375 and a term of
5.5 years. The placement agent warrants had a fair value of $ 325,699 as of the date of their issuance, using a Black-Scholes model and
were recorded as an equity issuance cost.
13
Common Share Warrants
The assumptions
used in the Black-Scholes model to value the new warrants issued during the nine months ended March 31, 2024, are set forth in the
table immediately below.
2024
Exercise price
$
0.83 – 1.04
Risk-free interest rate
4.82
%
Volatility
109 – 111
%
Expected life (years)
5.0 – 5.5
Dividend yield
$
0
%
The assumptions
used in the Black-Scholes model to value the modification of warrants issued during the nine months ended March 31, 2024, are set
forth in the table immediately below.
2024
Exercise price
$
0.83 – 3.04
Risk-free interest rate
0.56 – 4.82
%
Volatility
109 – 614
%
Expected life (years)
0 – 6.8
Dividend yield
$
0
%
A summary of the Company’s
warrant activity and related information for the periods covered were as follows:
Number of
Shares
Under
Warrants
Weighted
Average
Exercise
Price
Warrants Outstanding at July 1, 2023
3,516,529
$ 3.83
Warrants Granted
12,978,075
0.64
Exercised
( 3,272,733 )
0.83
Expire/Cancelled
( 17,778 )
18.50
Warrants Outstanding at March 31, 2024
13,204,093
$ 0.87
Warrants Exercisable at March 31, 2024
13,204,093
$ 0.87
As of March 31,
2024, the warrants exercisable and outstanding have an intrinsic value of $ 1,096,085 with a weighted average remaining life of 4 years.
14
8.
SHARE-BASED
PAYMENTS
a)
Option Plan Details
On March 24, 2017, and as amended on November 20, 2020, the Company’s
shareholders approved: (i) the adoption of a new stock option plan (the “Plan”) pursuant to which the Company’s Board
of Directors may, from time to time, in its discretion and in accordance with applicable regulatory requirements, grant to directors,
officers, employees and consultants of the Company, non-transferable options to purchase common shares, provided that the number of common
shares reserved for issuance will not exceed twenty percent ( 20 %) of the issued and outstanding common shares at the date the options
are granted (on a non-diluted and rolling basis); and (ii) the application of the Plan to all outstanding stock options of the Company
that were granted prior to March 24, 2017 under the terms of the Company’s previous stock option plan. On December 19, 2023, the
Company’s Board of Directors approved the reservation of an additional 700,000 common shares under the Plan
(which common shares were registered on the Company’s Form S-8 previously filed with the SEC on December 22, 2023).
As of March 31,
2024 and June 30, 2023, there were 174,353 and 51,633 options, respectively, immediately available for future allocation pursuant to
applicable regulatory requirements. The maximum number of options issuable under the terms of the Plan equates to 20 % of the then issued
and outstanding shares. The option price under each option shall not be less than the closing price on the day prior to the date of grant.
All options vest upon terms as set by the Board of Directors, either over time, up to 36 months, or upon the achievement of certain corporate
milestones.
Stock options
granted prior to May 2021 were granted with Canadian dollar exercise prices (U.S. dollar amounts for weighted average exercise prices
and aggregate intrinsic value are calculated using prevailing rates as at June 30, 2022). Commencing in May 2021, stock options are granted
with U.S. dollar exercise prices.
On December 23,
2023, the Company issued 502,000 options to its employees and consultants pursuant to the Plan. The options have an exercise price of
$ 0.37 with a term of 5 years. The options vest in equal installments monthly over three years.
On December 23,
2023, the Company additionally issued 28,400 options to members of the Company’s Board of Directors pursuant to the Plan. The options
have an exercise price of $ 0.37 with a term of five years . The options vest on the earlier of (i) December 23, 2024 or (ii) immediately
prior to the next Annual General Meeting.
On February
20, 2024, the Company issued 50,000 options to its employees pursuant to the Plan. The options have an exercise price of $ 0.37 with
a term of five years . The options vest in equal installments monthly over three years.
The assumptions
used in the Black-Scholes model during the nine months ended March 31, 2024, are set forth in the table immediately below:
2024
Exercise price
$
0.37
Risk-free interest rate
3.95 - 4.30
%
Volatility
116 - 203
%
Expected life (years)
3.5 - 3.6
Dividend yield
$
0
%
15
The following
is a summary of changes in outstanding options from July 1, 2023 to March 31, 2024:
Number
Weighted
Average
Exercise Price
Balance at July 1, 2023
102,642
$ 31.28
Granted
580,400
0.37
Expired/Forfeited
( 4,567 )
386.97
Balance at March 31, 2024
678,475
$ 2.96
March 31, 2024:
Vested and exercisable
112,920
$ 15.39
Unvested
565,555
$ 0.47
ii)
Expenses Arising from Share-based
Payment Transactions:
Total expenses arising
from share-based payment transactions recognized during the three months ended March 31, 2024 and 2023 were $ 55,305 and $ 50,357 , respectively,
of which $ 9,768 and $ 28,442 , respectively, was allocated to general and administrative expenses, $ 6,659 and $ 21,915 , respectively, was
allocated to research and development expenses, and $ 506 and $ 0 , respectively, was allocated to Cost of Goods sold.
Total expenses arising from share-based payment transactions recognized
during the nine months ended March 31, 2024 and 2023 were $ 98,760 and $ 237,675 , respectively, of which $ 57,231 and $ 137,555 , respectively,
was allocated to general and administrative expenses, $ 41,024 and $ 100,120 , respectively, was allocated to research and development expenses,
and $ 505 and $ 0 , respectively, was allocated to Cost of Goods sold.
Unrecognized
compensation cost at March 31, 2024 related to unvested options was $ 146,413 which will be recognized over a weighted-average vesting
period of approximately 1.4 years.
9.
LEASE OBLIGATIONS
The Company is committed to minimum lease payments as follows:
Maturity Analysis
March 31,
2024
Year 1
$ 388,703
Year 2
364,043
Year 3
374,965
Year 4
31,325
Year 5
-
More than five years
-
Total undiscounted lease liabilities (1)
1,159,035
Less: imputed interest
( 88,254 )
Present value of lease liabilities
1,070,781
Less: Current portion of lease liabilities
( 345,545 )
Non-current portion of lease liabilities
725,236
(1) Excludes estimated variable operating costs of $ 92,964 and $ 78,500 on an annual basis through to April 30, 2024 and August 31, 2024, respectively.
On October 5,
2023, BayMedica amended its lease located at 458 Carlton Court, Suite C, South San Francisco, California, in order to extend its lease
to May 14, 2027. The Company is obligated to pay $ 1,095,104 over the three-year period unless terminated before the end of the period.
The Company used an incremental borrowing rate of 6.15 % and recognized a right-of-use asset and corresponding operating lease liability
of $ 968,376 .
16
10.
SEGMENT INFORMATION
The
Company reports segment information based on the management approach which designates the internal reporting used by the Chief
Operating Decision Maker (“CODM”), which is the Company’s Chief Executive Officer and the senior management team,
for making decisions and assessing performance as the source of the Company’s reportable segments. The CODM allocates
resources and assesses the performance of each operating segment based on potential licensing opportunities, historical and
potential future product sales, operating expenses, and operating income (loss) before interest and taxes. The Company has
determined its reportable segments to be InMed Pharmaceuticals (‘InMed Pharma’) and BayMedica Commercial based on the
information used by the CODM. Other than cash, cash equivalents and short-term investments (“Unrestricted cash”)
balances, the CODM does not regularly review asset information by reportable segment and, therefore, the Company does not report
asset information by reportable segment.
The InMed Pharma segment is largely organized around the research and development
of small molecule pharmaceuticals drug candidates and the BayMedica Commercial segment is largely organized around manufacturing
technologies to produce and commercialize bulk rare cannabinoids for sale as ingredients in the health and wellness industry. Total assets
held in the InMed Pharma segment as of March 31, 2024 and June 30, 2023 are $ 10.8 million and $ 11.2 million, respectively. Total assets
as of March 31, 2024 and June 30, 2023, held in the BayMedica segment are $ 2.6 million and $ 3.0 million, respectively.
The following table presents information about the Company’s
reportable segments for the three months and nine months ended March 31, 2024 and 2023:
For the three months ended
March 31, 2024
March 31, 2023
InMed
Pharma
BayMedica
Commercial
Total
InMed
Pharma
BayMedica
Commercial
Total
$
$
$
$
$
$
Sales
-
1,172,601
1,172,601
-
1,033,925
1,033,925
Cost
of sales
-
883,143
883,143
-
841,414
841,414
Gross profit
-
289,458
289,458
-
192,511
192,511
Research
and development and patents
620,223
36,541
656,764
870,837
7,466
878,303
General
and administrative
1,172,023
202,072
1,374,095
1,213,047
199,680
1,412,727
Amortization
and depreciation
54,168
599
54,767
50,261
428
50,689
Other
expense
48,156
-
48,156
2,733
-
2,733
Total operating
expenses
1,894,570
239,212
2,133,782
2,136,878
207,574
2,344,452
Other income (expense)
102,987
18,471
121,458
155,567
( 70 )
155,497
Tax expense
-
-
-
-
( 1,500 )
( 1,500 )
Net Income
(loss)
( 1,791,583 )
68,717
( 1,722,866 )
( 1,981,311 )
( 15,133 )
( 1,997,944 )
Unrestricted
cash
6,578,230
1,022,368
7,600,598
9,441,977
162,080
9,604,057
For the nine months ended
March 31, 2024
March 31, 2023
InMed
Pharma
BayMedica
Commercial
Total
InMed
Pharma
BayMedica
Commercial
Total
$
$
$
$
$
$
Sales
-
3,314,663
3,314,663
-
1,824,496
1,824,496
Cost of sales
-
2,416,417
2,416,417
-
1,415,068
1,415,068
Inventory
write-down
-
263,404
263,404
-
576,772
576,772
Gross profit
-
634,842
634,842
-
( 167,344 )
( 167,344 )
Research
and development and patents
2,458,576
100,072
2,558,648
2,991,525
116,787
3,108,312
General
and administrative
3,434,917
601,867
4,036,784
3,854,275
583,808
4,438,083
Amortization
and depreciation
163,045
1,788
164,833
147,754
1,032
148,786
Other
expense
36,717
-
36,717
79,242
45
79,287
Total operating
expenses
6,093,255
703,727
6,796,982
7,072,796
701,672
7,774,468
Other
income (expense)
424,480
( 219 )
424,261
344,083
( 202 )
343,881
Tax expense
-
-
-
-
( 11,300 )
( 11,300 )
Net Income
(loss)
( 5,668,775 )
( 69,104 )
( 5,737,879 )
( 6,728,713 )
( 869,218 )
( 7,609,231 )
Unrestricted
cash
6,578,230
1,022,368
7,600,598
9,441,977
162,080
9,604,057
Other Income (expense) includes interest income earned on cash and
short-term investments, interest expense, and sublease income.
17
11.
COMMITMENTS AND CONTINGENCIES
Pursuant to the
terms of agreements with various contract research organizations, as of March 31, 2024, the Company is committed for contract research
services and materials at a cost of approximately $ 1.5 million, which is expected to occur in the following twelve months period following
March 31, 2024.
Pursuant to the
terms of agreements with various vendors, as of March 31, 2024, the Company is committed for contract materials and equipment at a cost
of approximately $ 1.0 million, which is expected to occur in the twelve months following March 31, 2024.
Pursuant to the
terms of a certain Technology Assignment Agreement, dated as of May 31, 2017 (the “Technology Agreement”), between the Company
and the University of British Columbia (“UBC”), the Company is committed to pay royalties to UBC on certain licensing and
royalty revenues received by the Company for biosynthesis of certain drug products that are covered by the Technology Agreement. To date,
no payments have been required to be made.
Pursuant to the
terms of a certain Collaborative Research Agreement, dated as of December 13, 2018, between the Company and UBC, pursuant to which the
Company owns all rights, title and interests in and to any intellectual property, in addition to funding research at UBC, the Company
is committed to make a one-time payment upon filing of any PCT patent application arising from the research. To date, one such payment
has been made to UBC.
Pursuant to the
terms of a certain Contribution Agreement, dated as of November 1, 2018, between the Company and National Research Council Canada, as
represented by its Industrial Research Assistance Program (NRC-IRAP), under certain circumstances contributions received, including the
disposition of the underlying intellectual property developed in part with NRC-IRAP contributions, may become repayable.
Short-term investments
include guaranteed investment certificates, with one-year terms of $ 43,085 and $ 44,422 as of March 31, 2024 and June 30, 2023, respectively,
that are pledged as security for a corporate credit card.
In addition to the foregoing, the Company has entered into certain
agreements in the ordinary course of operations that may include indemnification provisions, which are common in such agreements. In some
cases, the maximum amount of potential future indemnification is unlimited; however, the Company currently holds commercial general liability
insurance. This insurance may limit the Company’s overall liability and may enable the Company to recover a portion of any future
amounts paid. Historically, the Company has not made any indemnification payments under such agreements and it believes that
the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to
these obligations for any period presented.
Pursuant to a certain Technology Licensing Agreement, dated as of March
11, 2021, the Company is committed to issue, subject to regulatory approval, up to 700 warrants to purchase 700 common shares upon the
achievement of certain milestones. The exercise price of the warrants will be equal to the five-day VWAP of the common shares prior to
each milestone achievement and the warrants will be exercisable for a period of three years from the issuance date .
18
BayMedica entered
into a patent license agreement (“Patent License Agreement”) with a third party (the “Licensor”) on February
15, 2021. The Company was required to begin making royalty payments to the Licensor based on net sales of licensed products in 2021 in
order to maintain an exclusive license. In December 2021, the Company amended the Patent License Agreement, which amendment included
the deferral of the 2021 minimum payments to 2022. As of June 30, 2023, the Company has paid $ 300,000 for the minimum payments due and
payable under the Patent License Agreement. On February 10, 2023, BayMedica received a letter from the Licensor alleging a breach of
the Patent License Agreement and asserting a right to monies due thereunder. On April 6, 2023, BayMedica sent a letter to the Licensor
disputing the Licensor’s interpretation of the Patent License Agreement and asserted that the counterparty’s only remedy
under the Patent License Agreement to be either (a) the conversion of an exclusive technology license into a non-exclusive license or
(b) the termination of the Patent License Agreement. To date, the Licensor has not initiated a lawsuit with respect to the foregoing
matters. If a lawsuit is ultimately brought alleging a breach of the Patent License Agreement, the proceeding will be subject to final,
binding and non-appealable arbitration under the Arbitration Act, 1991 (Ontario) and determined pursuant to Ontario law. BayMedica intends
to vigorously defend its position. At this time, it is not possible to reasonably estimate a potential loss due to the terms of the Agreement,
the nature of the legal theory advanced by the counterparty, and the ultimate outcome of any proceeding (including the interpretation
by the arbitrator with respect to applicable requirements under Ontario law regarding contract formation).
From time to
time, the Company may be subject to various legal proceedings and claims related to matters arising in the ordinary course of business.
The Company does not believe it is currently subject to any material matters where there is at least a reasonable possibility that a
material loss may be incurred.
12.
RELATED PARTY TRANSACTIONS
On February
11, 2022, the Board of Directors appointed Janet Grove as a director of the Company. Ms. Grove is a Partner of Norton Rose Fulbright
Canada LLP (“NRF”). During the three months ended March 31, 2024 and 2023, NRF rendered legal services in the amount of
$ 66,000 and $ 91,232 , respectively, to the Company. During the nine months ended March 31, 2024 and 2023, NRF rendered legal services
in the amount of $ 197,155 and $ 580,761 , respectively, to the Company. These transactions were in the normal course of operations and
were measured at the exchange amount which represented the amount of consideration established and agreed to by NRF. No legal
services rendered by NRF were rendered by Ms. Grove directly.
13.
SUBSEQUENT EVENTS
The Company evaluated
subsequent events and transactions that occurred after the balance sheet date up to the date that the consolidated financial statements
were issued. Based upon this review, other than as disclosed in Note 7, the Company did not identify any subsequent events that would
have required adjustment or disclosure in the consolidated financial statements.
On May 10, 2024,
the Company delivered a 90-day notice of termination to EyeCRO LLC with respect to the Technology Licensing Agreement, specifying an effective
date of termination of August 8, 2024, 2024 (see Note 11 – Commitments and Contingencies).
19
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on
Form 10-Q (this “Quarterly Report”) contains “forward-looking statements” within the meaning of United States
Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian
securities law, which are included but are not limited to statements with respect to InMed Pharmaceuticals Inc.’s (the “Company”
“InMed”, “we”, “our”, or “us”) anticipated results and progress of the Company’s
operations, research and development in future periods, plans related to its business strategy, and other matters that may occur in the
future. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts
not yet determinable and assumptions of management. We may, in some cases, use words such as “anticipate”, “believe”,
“could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”,
“project”, “will”, “would”, “budget”, “possible”, “should”, “future”,
and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking
statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties.
You should not place undue reliance on these forward-looking statements. Any statements contained herein that are not statements of historical
facts may be deemed to be forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking
statements. Among the factors that could cause actual results to differ materially are the risks and uncertainties described under “ Item
1A. Risk Factors ” of our Annual Report on Form 10-K for the year ended June 30, 2023, which was filed with the Securities and
Exchange Commission (the “SEC”) on September 29, 2023 (the “2023 Annual Report”), “Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations ” of this Quarterly Report, and the following:
●
The Company’s ability
to stem operating losses and the Company’s ability to obtain additional financing to fund its operations;
●
The revenues of BayMedica,
LLC (“BayMedica”) and the commercial viability of the products in its portfolio;
●
The Company’s ability
to effectively research, develop, manufacture and commercialize pharmaceutical drug candidates that will treat diseases with high
unmet medical needs;
●
The continued optimization
of key, proprietary manufacturing approaches and technologies;
●
Our ability to commercialize
and, where required, register products in the pharmaceutical R&D programs (“Product Candidates”) and those targeted
to the health and wellness sector (“Products”) in the United States and other jurisdictions;
●
Our success in initiating
discussions with potential partners for licensing various aspects of our Product Candidates;
●
Our ability to successfully
access existing manufacturing capacity via leases with third-parties or to transfer our manufacturing processes to contract manufacturing
organizations;
●
Our belief that our manufacturing
approaches that we are developing are robust and effective and will result in commercially viable yields of cannabinoids and will
be a significant improvement upon existing manufacturing platforms;
●
The ability of the IntegraSyn
approach to introduce a revenue stream to us before the expected commercial approval of our therapeutic programs;
●
Our ability to successfully
scale up our IntegraSyn or other cost-effective approaches so that it will be commercial-scale ready after Phase 2 clinical trials
are completed, after which time we may no longer need to source active pharmaceutical ingredients (“APIs”) from API manufacturers;
●
The success of the key
next steps in our manufacturing approaches, including continuing efforts to diversify the number of cannabinoids produced, scaling-up
the processes to larger vessels and identifying external vendors to assist in the commercial scale-up of the process;
●
Our ability to successfully
make determinations as to which research and development programs to continue and pursue, including the ability to adequately assess
the underlying strategic factors;
●
Our ability to monetize
our IntegraSyn manufacturing approach to the broader pharmaceutical industry;
●
Our ability to outsource
the majority of our research and development activities through scientific collaboration agreements and arrangements with various
scientific collaborators, academic institutions and their personnel;
●
The success of work to
be conducted under the research and development collaboration between us and various contract development and manufacturing organizations
(“CDMOs”);
●
Our ability to develop
our therapies through early human testing;
20
●
Our ability to evaluate
the financial returns on various commercialization approaches for our Product Candidates, such as a ‘go-it-alone’ commercialization
effort, out-licensing to third parties, or co-promotion agreements with strategic collaborators;
●
Our ability to find a partnership
early in the development process for our various programs;
●
Our ability to explore
our manufacturing technologies as processes which may confer certain benefits, either cost, yield, speed, or all of the above, when
pursuing specific types of cannabinoids, and filing a provisional patent application for same;
●
Plans regarding our next
steps, options, and targeted benefits of our manufacturing technologies;
●
Our IntegraSyn- or BayMedica-derived
products being bio-identical to the naturally occurring cannabinoids, and offering superior ease, control and quality of manufacturing
when compared to alternative methods;
●
Our ability to potentially
earn revenue from our IntegraSyn approach by (i) becoming a supplier of APIs to the pharmaceutical industry and/or (ii) providing
pharmaceutical-grade ingredients to the non-pharmaceutical market;
●
U.S. Food and Drug Administration
(“FDA”) regulatory acceptance of synthesizing Product Candidates for potential use in the pharmaceutical industry;
●
Our ability to successfully
file, prosecute and defend patent applications;
●
The potential for any of
our patent applications to provide intellectual property protection for us;
●
The termination or renegotiation
of our supplier, technology and other material contracts, including the invoking of force majeure or termination clauses, and actual
or threatened claims of our failure to comply with any obligations set forth under such contracts;
●
The adequacy of, or gaps
in, insurance coverage upon the occurrence of a catastrophic or other material adverse event, as well as our ability to (i) expand
our insurance coverage to include the commercial sale of Products and Product Candidates and (ii) secure insurance coverage for shipping
and storage of Product Candidates, and clinical trial insurance;
●
Developing patentable New
Chemical Entities (“NCE”) which, if issued, will confer market exclusivity to us for the potential development into pharmaceutical
Product Candidates, license, partner or sell to interested external parties;
●
Our ability to initiate
discussions and conclude strategic partnerships to assist with development of certain programs;
●
Our ability to position
ourselves to achieve value-driving, near term milestones for our Product Candidates with limited investment;
●
Our ability to effectively
execute our business strategy;
●
The sufficiency of our
internal controls, including any exposure arising from the failure to (i) establish and maintain effective internal control over
financial reporting in accordance with applicable regulatory requirements, and (ii) fully remediate any material weaknesses identified
with respect to such internal controls;
● Epidemics, pandemics, global health crises, or other public
health events and concerns, including any future resurgence of COVID-19, and the effectiveness of associated vaccinations and treatments;
● Consolidation of our competitors and suppliers;
● Effects of new products and new technology on the market,
including through the use of artificial intelligence;
● The impact of geopolitical, global, regional or local economic
and financial market risks and challenges, applicability of foreign laws, including foreign labor and employment laws, foreign tax and
customs regimes, and foreign currency exchange rate risk;
● Political disturbances, geopolitical instability and tensions,
or terrorist attacks, and associated changes in global trade policies and economic sanctions, including, but not limited to, in connection
with (i) the Russo-Ukrainian war and (ii) any impact, effect, damage, destruction and/or bodily harm directly or indirectly relating
to the ongoing hostilities in the Middle East;
21
● Changes in the status of pending, or the initiation of new
litigation, claims, disputes or proceedings, including those involving our contractual counterparties, as well as our ability to prevail
in the defense of any claim, dispute, proceedings, appeal or counterclaim;
● Changes in legislation removing or increasing current applicable
limitations of liability;
● Governmental, tax and environmental regulations and related
actions and legal matters, including the actions taken by governments in response to any global health events and crises, as well as
the results and effects of legal proceedings and governmental audits, assessments, orders and investigations;
● Our ability to incur indebtedness in the near- and long-term;
● Our dependence on key personnel, the availability of such
personnel and the related labor costs; ·
● Our ability to identify and complete strategic and/or transformational
transactions, including acquisitions, dispositions, joint ventures and mergers, as well as the impact that such transactions may have
on our operations and financial condition;
● Adverse macroeconomic conditions, including (i) inflationary
pressures and potential recessionary conditions, as well as actions taken by central banks and regulators across the world in an attempt
to reduce, curtail and address such pressures and conditions, and (ii) developments at financial institutions, including bank failures,
that impact general sentiment regarding the stability and liquidity of banks and the global economy, and the resulting impact on the
stability of the global financial markets at large;
● The fact that (i) the Company may not be able to meet the
requirements for continued listing under the Nasdaq Listing Rules, (ii) the Company may not meet the Minimum Bid Price Rule (as defined
below) during the Extended Compliance Period (as defined below) or any other compliance period in the future, (iii) Nasdaq Capital Market
(“Nasdaq”) may not grant the Company relief from delisting, if necessary, and (iv) the Company may not ultimately meet applicable
Nasdaq requirements if any such relief is necessary, among other risks and uncertainties;
● The occurrence of cybersecurity incidents, attacks, intrusions
or other breaches to our information technology systems, and our ability to effectively and expeditiously remediate any such matters;
● Increased costs resulting from supply chain constraints,
delays and impediments, including, but not limited to, increases in the costs of obtaining supplies;
● The Company’s incurrence of significant operating losses,
both in the near- and long-term;
● Critical accounting estimates;
● Management’s assessment of future plans and operations;
●
The outlook of our business
and the global economic and geopolitical conditions; and
●
Competition within our
industry, and the competitive environment in which we and our business units operate.
This list is not exhaustive
of the factors, events, conditions and circumstances that may affect the “forward-looking statements” and “forward-looking
information” contained in this Quarterly Report. Although we have attempted to identify important factors that could cause actual
results to differ materially from those described in forward-looking statements, there may be other factors that cause results not to
be as anticipated, estimated or intended. Should one or more of these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those anticipated, believed, estimated, or expected. We caution readers not
to place undue reliance on any such forward-looking statements, which speak only as of the date made and are based only on the information
available to us at that time. Except as required by law, we disclaim any obligation to subsequently revise any forward-looking statements
to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
22
ITEM 2. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Three and Nine Months Ended March 31, 2023
This discussion and analysis
contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is subject to the
safe harbor created by those sections. For more information, see “Cautionary Note Regarding Forward-Looking Statements.”
When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that impact our business. In particular,
we encourage you to review the risks and uncertainties described in “Risk Factors” in the 2023 Annual Report, and other filings
we make from time to time with the SEC. These risks and uncertainties could cause actual results to differ materially from those projected
or implied by our forward-looking statements contained in this report. These forward-looking statements are made as of the date of this
report, and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law.
The following discussion
and analysis should be read in conjunction with our unaudited condensed consolidated financial statements for the three and nine
months ended March 31, 2024, and the related notes thereto, which have been prepared in accordance with U.S. GAAP. Additionally, the
following discussion and analysis should be read in conjunction with our audited consolidated financial statements included in the 2023
Annual Report. Throughout this discussion, unless the context specifies or implies otherwise the terms “InMed,” “Company,”
“we,” “us,” and “our” refer to InMed Pharmaceuticals Inc.
All dollar amounts stated herein are in
U.S. dollars unless specified otherwise.
Overview
We are a clinical stage pharmaceutical
company developing a pipeline of proprietary small molecule drug candidates that are preferential signaling ligands of the endogenous
cannabinoid 1 (“CB1”) and cannabinoid 2 (“CB2”) receptors as well as other receptor targets linked to human disease.
CB1 and CB2 receptors are each part of the endocannabinoid system that is found throughout the human body and is responsible for many
homeostatic functions. CB1 receptors are primarily located in the brain and central nervous system, while CB2 receptors are involved
in modulating neuroinflammation and immune responses. Our research efforts target the treatment of diseases with high unmet medical needs.
Together with our wholly-owned subsidiary, BayMedica, we also have significant know-how in developing proprietary manufacturing approaches
to produce and sell bulk rare cannabinoids as ingredients for various market sectors.
23
InMed has sought to focus
on the research and development of preferential signaling ligands of CB1/CB2 and has produced a library of novel, proprietary drug candidates.
These candidates are patentable new chemical entities (“NCEs”) for pharmaceutical development, aimed at targeting diverse
clinical indications. Our current pharmaceutical pipeline consists of three programs, with drug candidates targeting Alzheimer’s
disease, dry age-related macular degeneration, and Epidermolysis Bullosa. InMed’s INM-901 is a proprietary drug candidate being
developed as a potential treatment for Alzheimer’s disease. INM-901 has multiple potential mechanisms of action as a preferential
signaling agonist for both CB1 and CB2 receptors, as well as impacting the peroxisome proliferator-activated receptor (“PPAR”)
signaling pathway. Combined, these mechanisms of action may offer a unique treatment approach targeting several biological pathways associated
with Alzheimer’s disease. Our ocular research, based on a proprietary small molecule, INM-089 indicates potentially promising neuroprotective
effects in the back of the eye, which may lead to the preservation of the retinal function. Neuroprotection in dry Aged-related Macular
Degeneration (“dry AMD”) remains an unmet medical need and a new treatment option may help solve this multifactorial disease.
InMed has also completed
a Phase 2 clinical trial of INM-755 (cannabinol) cream studying its safety and efficacy in Epidermolysis Bullosa (“EB”).
Results from the Phase 2 clinical trial showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol cream versus
the control cream alone in an exploratory clinical evaluation. The results for non-wound itch were not statistically significant in this
small trial due, in part, to the clinically important anti-itch effect of the underlying control cream.
Together with our wholly-owned
subsidiary BayMedica, our manufacturing capabilities include traditional approaches such as chemical synthesis and biosynthesis, as well
as a proprietary, integrated manufacturing approach called IntegraSyn. With multiple manufacturing approaches, InMed has sought to maintain
enhanced flexibility to select the most cost-effective method to deliver high quality, pure cannabinoids fit for their intended use.
BayMedica’s commercial business specializes in the B2B supply of bulk rare cannabinoids as raw materials for the Health and Wellness
sector that are bioidentical to those found in nature.
Since our acquisition of Biogen
Sciences Inc., a privately held British Columbia pharmaceutical company focused on drug discovery and development in 2014, our operations
have primarily focused on conducting research and development for our Product Candidates and for our integrated, biosynthesis-based manufacturing
technology, establishing our intellectual property, organizing and staffing our Company, business planning and capital raising. On October
13, 2021, we acquired BayMedica, Inc., now named BayMedica, LLC. Upon closing of the acquisition of BayMedica, BayMedica became a wholly-owned
subsidiary of InMed. To date, we have funded our operations primarily through the issuance of our common shares.
We have incurred significant operating losses since our inception and we
expect to continue to incur significant operating losses for the foreseeable future. Our ability to generate product revenue that is sufficient
to achieve profitability will depend heavily on the revenues generated from our products in the health and wellness sector, on the successful
development and eventual commercialization of one or more of our Product Candidates and/or the success of our manufacturing technologies.
Our net loss was $5.7 million and $7.6 million for the nine months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 we
had an accumulated deficit of $107.1 million, which includes all losses since our inception in 1981. We expect our expenses will remain
steady in the near- and long-term as we:
●
seek partnership(s) to
advance the INM-755 program for the treatment of EB and/or other dermatological conditions including chronic itch;
●
continue to advance research
with proprietary drug candidates in the INM-901 program targeting treatment of neurodegenerative diseases such as Alzheimer’s
and in the INM-089 program to treat dry AMD;
●
investigate our Product
Candidates for additional uses beyond their initial target indications;
24
●
pursue the discovery of
additional small molecule drug candidates for other diseases with high unmet medical needs and the subsequent development of any
resulting new Product Candidates;
●
seek regulatory approvals
for any Product Candidates that successfully complete clinical trials;
●
scale-up our manufacturing
processes and capabilities, or arrange for a third party to do so on our behalf;
●
continue to support our
commercial operations and revenue-generating Products at BayMedica;
●
execute on business development
activities, including but not limited through strategic transactions, mergers, acquisitions and/or divestitures as well as
in- or out-licensing of technologies or business units;
●
maintain, expand, enforce,
defend and protect our intellectual property;
●
continue to further advance
the research and development of various manufacturing technologies;
●
build internal infrastructure,
including personnel, to meet our milestones; and
●
add operational, financial
and management information systems and personnel, including personnel to support product development and potential future commercialization
efforts and our operations as a public company.
As a result of these activities
as well as our working capital requirements, we will need substantial additional funding to support our continuing operations and pursue
our growth strategy. We expect to finance our operations through product sales, the sale of equity, debt financings or other capital
sources, including collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or
enter into such other agreements or arrangements when needed on favorable terms, if at all. If we fail to raise capital or enter into
such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization
of one or more of our Products and Product Candidates or grant rights to external entities to develop and market our Product Candidates,
even if we would otherwise prefer to develop and market such Products and Product Candidates ourselves.
Because of the numerous risks
and uncertainties associated with drug development and commercial growth, we are unable to predict the timing or amount of increased
expenses and working capital requirements or the timing of when or if we will be able to achieve or maintain profitability. If we fail
to become profitable or are unable to sustain profitability on a continual basis, then we may be unable to continue our operations at
current or planned levels and be forced to reduce or terminate our operations.
Recent Developments
Appointment of Dr.
David G. Morgan to the Scientific Advisory Board
On April 18, 2024, the Company
announced the addition of Dr. David G. Morgan, a renowned leader in neurodegenerative disease, to its Scientific Advisory Board (“SAB”)
reinforcing the Company’s commitment to advancing it’s INM-901 program in the treatment of Alzheimer’s disease.
Ocular Research Program
On April 16, 2024, the Company
announced additional preclinical data for INM-089 further demonstrating positive pharmacological effects targeting dry AMD. In vivo
preclinical studies in AMD disease models demonstrated significant outcomes for INM-089 including neuroprotection of photoreceptors
as well as improved photoreceptor’s function, improved integrity of retinal pigment epithelium and reduction in extracellular autofluorescent
deposits, a hallmark of dry AMD. Additionally, 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 common in more advanced cases of dry AMD, affecting the center of the macula.
The Company has strategically
prioritized the utilization of its proprietary small molecule drug candidates in its drug development initiatives, resulting in the advancement
of the INM-089 program in the treatment of dry AMD taking precedence over the INM-088 program in the treatment of glaucoma. Therefore,
the Company will not be advancing INM-088 in the immediate future. Notably, the initial research and data from the INM-088 program have
played an instrumental role in shaping the development of INM-089 program.
25
Additional Preclinical Data for INM-901’s
Pharmacological Effects
On April 4, 2024, the Company
announced additional preclinical data demonstrating INM-901’s positive pharmacological effects in the potential treatment of Alzheimer’s
disease. Several preclinical studies were conducted in well-characterized in vivo Alzheimer’s disease models demonstrating
that INM-901 is a preferential signaling agonist of the CB1/CB2 receptors and impacts the PPAR signaling pathway, reduces neuroinflammation
and improves neuronal function. Analysis of mRNA data supports the observations made in the previously released behavioral studies results
showing improvement of locomotor activity, cognition and memory in diseased animals.
Extension of Compliance
Period for Minimum Bid Price Rule Compliance
On March 19, 2024, the Company
received written notification from the Listing Qualifications Department of Nasdaq that the Company has been granted an additional 180-day
compliance period, or until September 16, 2024 (the “Extended Compliance Period”), to regain compliance with Nasdaq’s
minimum bid price requirement for the continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2)
(the “Minimum Bid Price Rule”). Nasdaq’s determination is based on the Company meeting the continued listing requirement
for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market, with
the exception of the bid price requirement, and the Company’s written notice of its intention to consider all available options
to regain compliance during the Extended Compliance Period, including, if necessary, effecting a reverse stock split. If at any time
prior to September 16, 2024, the closing bid price of the Company’s listed shares on Nasdaq (the “Listed Shares”) is
at least $1.00 per share for at least a minimum of 10 consecutive business days, the Company will regain compliance with the Minimum
Bid Price Rule and this matter will be closed. If the Company does not regain compliance with the Minimum Bid Price Rule during the Extended
Compliance Period, Nasdaq will provide written notification to the Company that the Listed Shares will be delisted. At that time, the
Company may appeal the relevant delisting determination to a hearings panel (the “Hearings Panel”) pursuant to the procedures
set forth in the Nasdaq Listing Rules. However, if the Company does appeal Nasdaq’s delisting determination to the Hearings Panel,
there can be no assurance that such appeal would be successful.
Other Personnel Matters
On February 20, 2024, Ms.
Netta Jagpal joined the Company as Chief Financial Officer and Corporate Secretary. In conjunction with this appointment, Mr. Jonathan
Tegge stepped down as interim Chief Financial Officer.
On May 10, 2024, Ms. Alexandra
D.J. Mancini, Senior Vice President, Clinical & Regulatory Affairs, provided notice to the Company and the Company’s Board
of Directors of her intention to retire from her position, effective June 30, 2024. In connection with Ms. Mancini’s retirement
and eventual departure, and to ensure a smooth transition, the Company intends to retain Ms. Mancini under the terms of a Consulting Agreement
(the “Consulting Agreement”), pursuant to which Ms. Mancini will provide certain consulting services to the Company for a
period to be mutually agreed upon by both the Company, on the one hand, and Ms. Mancini, on the other. The foregoing description of the
Consulting Agreement does not purport to be complete and is subject, and qualified by reference, to the full text of the Consulting Agreement,
which the Company intends to file with its Annual Report on Form 10-K for the year ending June 30, 2024.
Notice of Termination
with Respect to the Technology Licensing Agreement
On May 10, 2024, the Company
delivered a 90-day notice of termination to EyeCRO LLC with respect to the Technology Licensing Agreement, specifying an effective date
of termination of August 8, 2024 (see Note 11 – Commitments and Contingencies to the unaudited condensed consolidated interim
financial statements included in this Quarterly Report, which is incorporated by reference in this Part I, Item 2 of this Quarterly Report).
Components of Results of Operations
Revenue
Our revenue consists of manufacturing
and distribution sales of rare cannabinoid products, which are generally recognized at a point in time. We recognize revenue when control
over the products has been transferred to the customer and to which we have a present right to payment.
Cost of Sales
Cost
of sales consists primarily of the purchase price of goods and cost of services rendered, freight costs, warehousing costs, and purchasing
costs. Cost of sales also includes production and labor costs for our manufacturing business.
26
Operating Expenses
Research and Development and Patent Expenses
Research and development
and patent expenses represent costs incurred by us for the discovery, development, and manufacture of our Products and Product Candidates
and include:
●
external research and development
expenses incurred under agreements with contract research organizations, or “CROs”, contract development and manufacturing
organization, or “CDMOs”, and consultants;
●
salaries, payroll taxes,
employee benefits expenses for individuals involved in research and development efforts;
●
research supplies; and
●
legal and patent office
fees related to patent and intellectual property matters.
We expense research and development
costs as incurred. We recognize expenses for certain development activities, such as preclinical studies and manufacturing, based on
an evaluation of the progress to completion of specific tasks using data or other information provided to us by our vendors. Payments
for these activities are based on the terms of the individual agreements, which may differ from the pattern of expenses historically
incurred. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities
are recorded as prepaid expenses. These amounts are recognized as an expense as the goods are delivered or the related services are performed,
or until it is no longer expected that the goods will be delivered, or the services rendered.
External costs represent
a significant portion of our research and development expenses, which we track on a program-by-program basis following the nomination
of a development candidate. Our internal research and development expenses consist primarily of personnel-related expenses, including
salaries, benefits and stock-based compensation expenses. We do not track our internal research and development expenses on a program-by-program
basis as the resources are deployed across multiple projects.
The successful development
of our Products and Product Candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing, and
estimated costs of the efforts that will be needed to complete the remainder of the development of our Product Candidates or to develop
and commercialize additional Products. We are also unable to predict when, if ever, material net cash inflows will commence from our
Product Candidates, if approved. This is due to the numerous risks and uncertainties associated with the development of our products,
including the uncertainties related to:
●
the timing and progress
of preclinical and clinical development activities;
●
the number and scope of
preclinical and clinical programs we decide to pursue;
●
our ability to raise additional
funds necessary to complete preclinical and clinical development and commercialization of our Product Candidates, to further advance
the development of our manufacturing technologies, and to develop and commercialize additional Products, if any;
●
our ability to maintain
and expand our current research and development programs and to establish new ones;
●
our ability to establish
sales, licensing or collaboration arrangements;
●
the progress of the development
efforts of parties with whom we may enter into collaboration arrangements;
●
the successful initiation
and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable
foreign regulatory authority;
27
●
the receipt and related
terms of regulatory approvals from applicable regulatory authorities;
●
the availability of materials
for use in production of our Products and Product Candidates;
●
our ability to secure manufacturing
supply through relationships with third parties or establish and operate a manufacturing facility;
●
our ability to consistently
manufacture our Product Candidates in quantities sufficient for use in clinical trials;
●
our ability to obtain and
maintain intellectual property protection and regulatory exclusivity, both in the United States and internationally;
●
our ability to maintain,
enforce, defend and protect our rights in our intellectual property portfolio;
●
the commercialization of
our Product Candidates, if and when approved, and of new Products;
●
our ability to obtain and
maintain third-party payor coverage and adequate reimbursement for our Product Candidates, if approved;
●
the acceptance of our Product
Candidates, if approved, by patients, the medical community and third-party payors;
●
competition with other
products and within our industry at large; and
●
a continued acceptable
safety profile of our Product Candidates following receipt of any regulatory approvals.
A change in the outcome of
any of these variables with respect to the development of any of our Products or Product Candidates could significantly and materially
change the costs and timing associated with the development of those Products or Product Candidates.
Research and development
activities account for a significant portion of our operating expenses. Research and development expenses decreased in the three and
nine months ended March 31, 2024 as compared to the three and nine months ended March 31, 2023, largely due to high start-up costs associated
with the multicenter Phase 2 clinical trial in our INM-755 program during the prior year. However, we expect our research and development
expenses to increase significantly in future periods as we continue to implement our business strategy, which includes advancing our
drug candidates and our manufacturing technologies into and through clinical development, expanding our research and development efforts,
including hiring additional personnel to support our research and development efforts, ultimately seeking regulatory approvals for our
drug candidates that successfully complete clinical trials, and further developing selected R&D and commercial BayMedica activities.
In addition, drug candidates in later stages of clinical development generally incur higher development costs than those in earlier stages
of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Accordingly, although we expect
our research and development expenses to increase as our drug candidates advance into later stages of clinical development, we do not
believe that it is possible, at this time, to accurately project total program-specific expenses through to commercialization. There
are numerous factors associated with the successful commercialization of any of our Product Candidates, including future trial design
and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.
28
General and Administrative Expenses
General and administrative
expenses consist of (i) personnel-related costs, including salaries, benefits and stock-based compensation expense, for our personnel
in executive, finance and accounting, human resources, business operations and other administrative functions, (ii) investor relations
activities, (iii) legal fees related to corporate matters, (iv) fees paid for accounting and tax services, (v) consulting fees and (vi)
facility-related costs.
Amortization and Depreciation
Intangible assets are comprised
of intellectual property that we acquired in May of 2014 and trade secrets, product formulation knowledge, and patents that we acquired
in October 2021. The acquired intellectual property and patents are amortized on a straight-line basis based on their estimated useful
lives. Equipment and leasehold improvements are depreciated using the straight-line method based on their estimated useful lives.
Share-based Payments
Share-based payments is the
stock-based compensation expense related to our granting of stock options to employees and others. The fair value, at the grant date,
of equity-settled share awards is charged to our loss over the period for which the benefits of employees and others providing similar
services are expected to be received. The vesting components of graded vesting employee awards are measured separately and expensed over
the related tranche’s vesting period. The amount recognized as an expense is adjusted to reflect the number of share options expected
to vest. The fair value of awards is calculated using the Black-Scholes option pricing model, which considers the exercise price, current
market price of the underlying shares, expected life of the award, risk-free interest rate, expected volatility and the dividend yield.
Other Income
Other income consists primarily
of interest income earned on our cash, cash equivalents and short-term investments.
Results of Operations
The Company has two operating
and reportable segments based on the management approach which designates the internal reporting used by the Chief Operating Decision
Maker (“CODM”), which is the Company’s Chief Executive Officer and the senior management team, for making decisions
and assessing performance as the source of the Company’s reportable segments. The CODM allocates resources and assesses the performance
of each operating segment based on potential licensing opportunities, historical and potential future product sales, operating expenses,
and operating income (loss) before interest and taxes. The Company has determined its reportable segments to be InMed Pharmaceuticals
(‘InMed Pharma’) and BayMedica Commercial based on the information used by the CODM.
Comparison of the three months ended March
31, 2024 and 2023 for the InMed Pharma Segment
Three months ended
March
2024
March
2023
Change
% Change
(in thousands)
Operating expenses:
Research and development and patents
$ 620
$ 871
$ (251 )
(29 )%
General and administrative
1,172
1,213
(41 )
(3 )%
Amortization and depreciation
54
50
4
8 %
Foreign exchange loss
48
3
45
1,500 %
Total operating expenses
1,894
2,137
(243 )
(11 )%
Interest and other income
103
156
(53 )
34 %
29
Research and Development and Patents Expenses
Research and development and patents expenses decreased by $0.3 million
in the InMed Pharma segment, or 29%, for the three months ended March 31, 2024, as compared to the three months ended March 31, 2023.
The decrease in research and development and patents expenses was due to the Company no longer being engaged in clinical trials resulting
in lower research supplies and external contractor fees, as well as lower personnel costs. However, we expect our research and development
expenses to increase significantly in future periods as we continue to implement our business strategy.
General and administrative expenses
General and administrative expenses decreased by $0.04 million in our
InMed Pharma segment, or 3%, for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 The decrease
results primarily from a combination of changes including lower office and admin fees, and salaries and benefits. This was offset by an
increase in accounting and legal, investor relations, and consulting fees.
Comparison of the three months ended March
31, 2024 and 2023 for BayMedica Commercial Segment
Three months ended
March 31,
2024
2023
Change
% Change
(in thousands)
Sales
$ 1,173
$ 1,034
$ 139
13 %
Cost of sales
883
841
42
5 %
Gross profit
290
193
97
50 %
Operating expenses:
Research and development and patents
37
7
30
429 %
General and administrative
202
201
1
- %
Amortization and depreciation
1
-
1
100 %
Total operating expenses
240
208
32
15 %
Interest and other income
18
-
18
100 %
Sales
Sales increased by $0.1 million, or 13%, to $1.2 million in the BayMedica
Commercial segment for the three months ended March 31, 2024, as compared to the three months ended March 31, 2023. While sales increased
year over year, revenue tends to fluctuate from quarter to quarter. The changes in revenue can be attributed mainly to distributor order
patterns. While we are generally optimistic about the long-term growth potential in the rare cannabinoids sector, we expect revenue fluctuations
to continue in future quarters. BayMedica Commercial 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 higher margins,
where BayMedica Commercial continues to hold a strong competitive position.
Cost of Sales
Cost of goods sold increased by $0.04 million, or 5%, to $0.9 million
in our BayMedica Commercial segment for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. The increase
in cost of goods sold is the direct result of an increase in BayMedica Commercial sales.
30
Research and Development and Patents Expenses
Research and development and patents expenses increased by $0.03 million
in our BayMedica Commercial segment to $0.4 million, or 429%, for the three months ended March 31, 2024, as compared to the three months
ended March 31, 2023. The increase in research and development and patents expenses was primarily due to external contractor fees for
testing and new product development.
Comparison of the nine months ended March
31, 2024 and 2023 for the InMed Pharma Segment
Nine months ended
March
2024
March
2023
Change
% Change
(in thousands)
Operating expenses:
Research and development and patents
$ 2,459
$ 2,992
$ (533 )
(18 )%
General and administrative
3,434
3,854
(420 )
(11 )%
Amortization and depreciation
163
148
15
10 %
Foreign exchange loss
37
79
(42 )
53 %
Total operating expenses
6,093
7,073
(980 )
(14 )%
Interest and other income
424
344
80
23 %
Research and Development and Patents Expenses
Research and development and patents expenses decreased by $0.5 million
to $2.5 million in our InMed Pharma segment, or 18%, for the nine months ended March 31, 2024, as compared to the period ended March 31,
2023. The decrease in research and development and patents expenses was due primarily to the Company no longer being engaged in clinical
trials which resulted in lower external contractor fees and research supplies. Furthermore, the decrease is the result of lower personnel
costs.
General and administrative expenses
General and administrative expenses decreased by $0.4 million to $3.4
million in the InMed Pharma segment, or 11%, for the nine months ended March 31, 2024, as compared to the nine months ended March 31,
2023. The decrease resulted primarily from a combination of changes including lower office and admin fees, personnel costs, regulatory
fees, and interest expense on lease obligations. This was offset by an increase in investor relations, accounting and legal fees,
and consulting fees
Comparison of the nine months ended March
31, 2024 and 2023 for the BayMedica Commercial Segment
Nine months ended
March 31,
2024
2023
Change
% Change
(in thousands)
Sales
$ 3,315
$ 1,824
$ 1,491
82 %
Cost of sales
2,416
1,415
1,001
70 %
Inventory write-down
263
577
(314 )
(54 )%
Gross profit
636
(168 )
804
(479 )%
Operating expenses:
Research and development and patents
100
116
(16 )
(14 )%
General and administrative
603
584
19
3 %
Amortization and depreciation
2
1
1
100 %
Total operating expenses
705
701
4
1 %
31
Sales
Sales increased by $1.5 million,
or 82%, to $3.3 million in the BayMedica Commercial segment for the nine months ended March 31, 2024, as compared to the nine months ended
March 31, 2023, which was primarily the result of an increase in sales volume. While sales increased year over year, revenue generally
fluctuates from quarter to quarter. The changes in revenue can be attributed mainly to distributor order patterns. While we are optimistic
about the long-term growth potential in the rare cannabinoids sector, we expect revenue fluctuations to continue in future quarters. 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.
Cost of Sales
Cost of goods sold increased by
$1.0 million, or 34%, to $2.4 million in our BayMedica Commercial segment for the nine months ended March 31, 2024 compared to the nine
months ended March 31, 2023. The increase in cost of goods sold is primarily a result of the increase in sales.
Inventory Write-Down
The write-down of inventories to net realizable value was $0.3 million,
or a decrease of 54%, in the BayMedica Commercial segment for the nine months ended March 31, 2024, as compared to expenses of $0.6 million
for the nine months ended March 31, 2023. Contributing factors to the decrease in net realizable value included lower demand, downward
pricing pressure, and changes in the manufacturing processes that required the write-down of raw materials. BayMedica continues to evaluate
new manufacturing approaches for certain products to increase its competitive position in the marketplace.
Research and Development and Patents Expenses
Research and development and patents expenses decreased by $0.02 million,
or 14%, to $0.01 million in the BayMedica Commercial segment for the nine months ended March 31, 2024 compared to the nine months ended
March 31, 2024. The decrease in research and development and patents expenses was due to a decrease in . expenses for new product development
and patent related expenses.
General and\Administrative Expenses
General and administrative expenses increased by $0.02 million, or
3%, to $0.6 million in the BayMedica Commercial segment, for the nine months ended March 31, 2024, as compared to the nine months ended
March 31, 2023. The increase primarily relates to a combination of changes including higher accounting, legal fees, and marketing expenses.
This was offset by lower personnel expenses.
Liquidity and Capital Resources
Since our inception, we
have only generated limited revenue from product sales, no sales from any other sources and have incurred significant operating
losses and negative cash flows from our operations. We have only commenced commercial sales with the acquisition of BayMedica and
have not yet commercialized any of our Product Candidates and we do not expect to generate revenue from sales of any Product
Candidates for several years, if at all. We have funded our operations to date primarily with proceeds from the sale of our common
shares.
32
As of March 31, 2024, we
had cash, cash equivalents and short-term investments of $7.6 million.
The following table summarizes
our cash flows for each of the periods presented:
(in thousands)
Nine Months
Ended
March 31,
2024
Nine Months
Ended
March 31,
2023
Net cash used in operating activities
$
(5,957
)
$
(6,625
)
Net cash used in investing activities
(9
)
(628
)
Net cash provided by financing activities
4,654
10,680
Net decrease in cash and cash equivalents
$
(1,312
)
$
(3,427
)
Operating Activities
During the nine months ended
March 31, 2024, we used cash in operating activities of $5.9 million, primarily resulting from our net loss of $5.7 million combined
with changes in working capital and non-cash expenses contributed to net cash used in operating activities.
During the nine months ended
March 31, 2023 we used cash in operating activities of $6.6 million, primarily resulting from our net loss of $7.6 million combined with
changes in working capital and non-cash expenses contributed to net cash used in operating activities.
Investing Activities
During
the nine months ended March 31, 2024, cash provided by investing activities of less than $0.01 million resulted from the purchases of
property and equipment.
During
the nine months ended March 31, 2023, cash used in investing activities of $0.6 million resulted from escrow payments made to BayMedica’s
historical equity and convertible debt holders, and the payment of a deposit on equipment.
Financing Activities
During the nine months ended
March 31, 2024, cash provided by financing activities of $4.7 million consisted of $5.2 million in gross proceeds derived from the 2023
Private Placement, offset by total transaction costs of $0.5 million.
During the nine months ended
March 31, 2023, cash provided by financing activities of $10.7 million consisted of $12.0 million in gross proceeds from private placements
of our common shares consummated in September 2022 and November 2022, offset by total transaction costs of $1.3 million.
Going Concern
We expect our expenses to
increase substantially in connection with our ongoing research and development activities, particularly as we continue the research and
development of and the clinical trials for our Product Candidates. In addition, we expect to incur additional costs associated with operating
as a US-listed public company and associated with any required investment into the Company’s research and development efforts targeting
small molecule drug candidates. As a result, we expect to incur substantial operating losses and negative operating cash flows for the
foreseeable future.
In accordance with the Financial
Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties
about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we have evaluated whether there are conditions and
events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after
the date that the consolidated financial statements are issued.
33
Through March 31, 2024, we
have funded our operations primarily with proceeds from the sale of our common shares. We have incurred recurring losses and negative
cash flows from operations since its inception, including net losses of $5.7 million for the nine months ended March 31, 2024. In addition,
we have an accumulated deficit of $107.1 million as of March 31, 2024.
As of the issuance date of the condensed consolidated financial statements,
we expect our cash, cash equivalents, and short-term investments of $7.6 million as of March 31, 2024, will be sufficient to fund our
operating expenses and capital expenditure requirements into the fourth 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. Our future viability is dependent on our ability to raise additional capital to finance our operations. In addition, there are
a number of uncertainties in estimating our operating expenses and capital expenditure requirements, including the impact of potential
acquisitions.
As a result, we have concluded
that there is substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated
financial statements are issued.
We expect to continue to
seek additional funding through equity financings, debt financings or other capital sources, including collaborations with other companies,
government contracts or other strategic transactions. We may not be able to obtain financing on acceptable terms, if at all. The terms
of any financing may materially and adversely affect the holdings or the rights of our existing equityholders.
Our funding requirements, and the timing
and amount of our operating expenditures will depend largely on:
●
the scope, progress, results
and costs of discovery research, preclinical development, laboratory testing and clinical trials for our Product Candidates;
●
the scope, progress, results
and costs of development of our manufacturing technologies;
●
the number of and development
requirements for other Products and Product Candidates that we pursue;
●
the costs, timing and outcome
of regulatory review of our Product Candidates;
●
our ability to enter into
contract manufacturing arrangements for supply of materials and manufacture of our Products and Product Candidates and the terms
of such arrangements;
●
the impact of any acquired,
or in-licensed, externally developed product(s) and/or technologies;
●
our ability to establish
and maintain strategic collaborations, licensing or other arrangements, including sales arrangements, and the financial terms of
such arrangements;
●
the sales, costs and timing
of future commercialization activities, including product manufacturing, sales, marketing and distribution, for any of our Products
and for Product Candidates for which we may receive marketing approval;
●
the costs and timing of
preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights
and defending any intellectual property- related claims;
●
expansion costs of our
operational, financial and management systems and increases to our personnel, including personnel to support our clinical development,
manufacturing and commercialization efforts and our operations as a dual listed company;
●
the costs to obtain, maintain,
expand and protect our intellectual property portfolio; and
●
the level and timing of
realizing revenues from the BayMedica commercial operations.
34
A change in the outcome of
any of these, or other variables with respect to the development of any of our Products and Product Candidates, could significantly and
materially change the costs and timing associated with their development. We anticipate that we will need to continue to rely on additional
financings to achieve our business objectives.
In addition to the variables
described immediately above, if and when any of our Product Candidates successfully complete development, we will incur substantial additional
costs associated with regulatory filings, marketing approval, post-marketing requirements, maintaining and safeguarding our intellectual
property rights, and regulatory protection, in addition to other commercial-related costs. We cannot reasonably estimate these costs
at this time.
Until such time, if ever,
we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements. We currently have
no credit facility or committed sources of capital. To the extent that we raise additional capital through the future sale of our equity
securities, the equity of our common shareholders will be diluted, and the terms of these securities may include liquidation or other
preferences that could materially and adversely affect the rights of our existing common shareholders. If we raise additional funds through
the issuance of debt securities, these securities could contain covenants that would restrict our operations. We may require additional
capital beyond our currently anticipated amounts, and additional capital may not be available on reasonable terms, or at all. If we raise
additional funds through collaboration arrangements or other strategic transactions in the future, we may have to relinquish valuable
rights to our technologies, future revenue streams, Products or Product Candidates, or grant licenses on terms that may not be favorable
to us. If we are unable to raise additional funds through equity or debt financings when needed, if at all, we may be required to materially
delay, limit, reduce or terminate development or future commercialization efforts or grant rights to develop and market Products or Product
Candidates that we would otherwise prefer to develop and market ourselves.
Off-Balance Sheet Arrangements
During the periods presented
in this Quarterly Report, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined in the rules
and regulations promulgated by the SEC.
Critical Accounting
Policies and Significant Judgments and Estimates
Our significant accounting
policies are described in Note 2 of the unaudited condensed consolidated financial statements included in this Quarterly Report.
The estimates will require us to rely upon assumptions that were highly uncertain at the time the accounting estimates are made, and
changes in them are reasonably likely to occur from period to period. Changes in estimates used in these and other items could have a
material impact on our financial statements in the future. Our estimates will be based on our experience and our interpretation of economic,
political, regulatory, and other factors that affect our business prospects. Actual results may differ significantly from our estimates.
For detailed information regarding our critical accounting policies and estimates, see our financial statements and notes thereto included
in this Quarterly Report and in the 2023 Annual Report. There have been no material changes to our critical accounting policies and estimates
from those disclosed in the 2023 Annual Report.
35
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK.
We are a smaller reporting
company as defined by Rule 12b-2 of the Exchange Act and, as such, are not required to provide the information under this Item.
ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Our disclosure controls and
procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) are designed to ensure that information required to be
disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time
periods specified in the rules and forms of the SEC and to ensure that information required to be disclosed is accumulated and communicated
to management, including our principal executive and financial officers, to allow timely decisions regarding disclosure. As of March
31, 2024, the Chief Executive Officer and the Chief Financial Officer, with assistance from other members of management, have reviewed
the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange
Act of 1934). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship
of possible controls and procedures. Based upon the evaluation, they have concluded that, as of March 31, 2024, our disclosure controls
and procedures were not effective at a reasonable assurance level due to a material weakness that existed in our internal controls over
financial reporting, primarily the result around a lack of personnel and inadequate controls around segregation of duties in the accounting
department from employee turnover, as previously disclosed in the 2023 Annual Report.
It should be noted that any
system of controls is based in part upon certain assumptions designed to obtain reasonable (and not absolute) assurance as to its effectiveness,
and there can be no assurance that any design will succeed in achieving its stated goals.
Changes in Internal Control Over Financial
Reporting
There have been no changes
in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during
our fiscal quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting, except for the items discussed in remediation below.
Remediation
We
have implemented a remediation plan which seeks to address the previously reported material weakness in internal control over financial
reporting, described in Part II, Item 9A, “Controls and Procedures” in our 2023 Annual Report. Remediation measures include,
but are not limited to, adding additional resources to our finance function, retaining the services of outside consultants, and establishing
additional review procedures over the accounting for complex and non-routine transactions. The material weakness will not be considered
remediated until, and to the extent, the newly designed controls operate for a sufficient period of time and management has concluded,
through testing, that these controls are operating effectively. While we currently anticipate that the remediation of this material weakness
should be completed by the end of our fourth quarter of this fiscal year, the elements of our remediation plan can only be accomplished
over time, and we can offer no assurance that these initiatives will ultimately have the intended effects (including within the anticipated
timeframe). Notwithstanding the material weakness, we believe the financial statements in this report fairly present, in all material
respects, our financial position, results of operations, and cash flows for the periods presented in conformity with U.S. GAAP.
36
PART II
ITEM 1. LEGAL PROCEEDINGS.
We are not presently involved
in any active legal proceedings that we believe to be material to the Company. However, from time to time, we may be subject to various
pending or threatened legal actions, claims and proceedings, including those that arise in the ordinary course of our business (including,
but not limited to, the matters discussed in Note 11 of the unaudited condensed financial statements included in this Quarterly
Report).
ITEM 1A. RISK FACTORS.
As a smaller reporting company
as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations
and therefore are not required to provide the information requested by this item. For a discussion of our potential risks and uncertainties,
please review the risks and uncertainties described in “1A. Risk Factors” in the 2023 Annual Report.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS.
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURE.
None
ITEM 5. OTHER INFORMATION.
Rule 10b5-1 Plan and Non-Rule 10b5-1 Trading
Arrangement Adoptions, Terminations, and Modifications
During the three months ended March 31, 2024,
none of our directors or “officers” (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule
10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation
S-K.
Retirement of Ms. Alexandra D.J. Mancini
On May 10, 2024, Ms. Alexandra D.J. Mancini, Senior Vice President,
Clinical & Regulatory Affairs, provided notice to the Company and the Company’s Board of Directors of her intention to
retire from her position, effective June 10, 2024. Ms. Mancini’s retirement was not the result of any disagreement with the Company
on any matter relating to the Company’s operations, policies or practices. In connection with Ms. Mancini’s
retirement and eventual departure, and to ensure a smooth transition, the Company intends to retain Ms. Mancini under the terms of a consulting
agreement (the “Consulting Agreement”), pursuant to which Ms. Mancini will provide certain consulting services to the Company
for a period to be mutually agreed upon by both the Company, on the one hand, and Ms. Mancini, on the other. The foregoing description
of the Consulting Agreement does not purport to be complete and is subject, and qualified by reference, to the full text of the Consulting
Agreement, which the Company intends to file with its Annual Report on Form 10-K for the year ending June 30, 2024.
Other than (i) as disclosed in this Item 5 of
this Quarterly Report and (ii) that certain executive employment agreement, dated as of March 1, 2021, between the Company and Ms. Mancini,
which was previously filed as Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed with the SEC on July
13, 2021, there are no arrangements or understandings between Ms. Mancini and any other persons pursuant to which she was appointed as
Senior Vice President, Clinical & Regulatory Affairs, of the Company. There are no family relationships between Ms. Mancini and any
director or executive officer of the Company, and she has no direct or indirect material interest in any transaction required to be disclosed
pursuant to Item 404(a) of Regulation S-K.]
37
ITEM 6. EXHIBITS.
Exhibits
The following exhibits are filed as part of this
report:
Exhibit
Number
Description
10.1
Scientific Advisory Board Consulting Agreement, dated as of April 12, 2024, between InMed Pharmaceuticals Inc. and David G. Morgan.
31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended
32.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
38
SIGNATURES
Pursuant to the requirements of Section 13 or
15(d) of the Securities Exchange Act of 1934 , the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
INMED PHARMACEUTICALS INC.
(Registrant)
Dated: May 13, 2024
By:
/s/
Netta Jagpal
Chief Financial Officer
39
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.