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 September 30,
2021
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 98-1067994
(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 November 10, 2021, the registrant had 14,137,034
common shares, without par value, outstanding.
INDEX
Page
PART I – FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
1
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
21
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
32
ITEM 4. CONTROLS AND PROCEDURES
32
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
33
ITEM 1A. RISK FACTORS
33
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
33
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
33
ITEM 4. MINE SAFETY DISCLOSURE
33
ITEM 5. OTHER INFORMATION
33
ITEM 6. EXHIBITS
34
SIGNATURES
35
i
PART I
ITEM 1. CONDENSED CONSOLIDATED INTERIM FINANCIAL
STATEMENTS.
Unaudited
Condensed Consolidated Interim Financial Statements of
InMed
Pharmaceuticals Inc.
For
the Three Months Ended September 30, 2021 and 2020
Suite
310 – 815 West Hastings Street
Vancouver,
BC, Canada, V6C 1B4
Tel:
+1-604-669-7207
1
InMed
Pharmaceuticals Inc.
(Expressed
in U.S. Dollars)
September
30, 2021
INDEX
Page
Financial Statements (Unaudited)
●
Condensed Consolidated Interim Balance Sheets
3
●
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss
4
●
Condensed Consolidated Interim Statements of Shareholders’ Equity
5
●
Condensed Consolidated Interim Statements of Cash Flows
6
●
Notes to the Condensed Consolidated Interim Financial Statements
7-18
2
InMed
Pharmaceuticals Inc.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS (unaudited)
As at September 30, 2021 and June 30, 2021
Expressed
in U.S. Dollars
September 30,
June 30,
Note
2021
2021
ASSETS
$
$
Current
Cash and cash equivalents
15,343,905
7,363,126
Short-term investments
45,224
46,462
Accounts receivable
14,842
11,919
Loan receivable
3
250,000
-
Prepaids and other assets
322,352
956,762
Total current assets
15,976,323
8,378,269
Non-Current
Property and equipment, net
4
304,934
326,595
Intangible assets, net
5
1,037,382
1,061,697
Other assets
8,625
14,655
Total Assets
17,327,264
9,781,216
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
Accounts payables and accrued liabilities
6
1,844,769
2,134,878
Current portion of lease obligations
9
82,232
80,483
Total current liabilities
1,927,001
2,215,361
Non-current
Lease obligations
9
178,591
189,288
Total Liabilities
2,105,592
2,404,649
Shareholders’ Equity
Common shares, no par value, unlimited authorized shares: 10,327,034 (June 30, 2021 - 8,050,707 ) issued and outstanding
7
63,686,724
60,587,417
Additional paid-in capital
7, 8
29,230,464
21,513,051
Accumulated deficit
( 77,824,085 )
( 74,852,470 )
Accumulated other comprehensive income
128,569
128,569
Total Shareholders’ Equity
15,221,672
7,376,567
Total Liabilities and Shareholders’ Equity
17,327,264
9,781,216
Commitments and Contingencies (Note 12)
Subsequent Events (Note 14)
The accompanying notes form an integral part of these condensed consolidated interim financial statements.
3
InMed
Pharmaceuticals Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited)
For the three months ended September 30, 2021 and 2020
Expressed in U.S. Dollars
Three Months Ended
September 30
Note
2021
2020
$
$
Operating Expenses
Research and development and patents
1,491,252
911,156
General and administrative
1,372,867
624,788
Amortization and depreciation
4, 5
28,532
27,981
Total operating expenses
2,892,651
1,563,925
Other Income (Expense)
Interest income
5,148
4,345
Foreign exchange loss
( 84,112 )
( 39,499 )
Net loss for the period
( 2,971,615 )
( 1,599,079 )
Other Comprehensive Loss
Foreign currency translation gain
-
129,400
Total comprehensive loss for the period
( 2,971,615 )
( 1,469,679 )
Net loss per share for the period
Basic and diluted
10
( 0.25 )
( 0.31 )
Weighted average outstanding common shares
Basic and diluted
10
12,047,555
5,220,707
The
accompanying notes form an integral part of these condensed consolidated interim financial statements.
4
InMed
Pharmaceuticals Inc.
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF SHAREHOLDERS’ EQUITY (unaudited)
For
the three months ended September 30, 2021 and 2020
Expressed in U.S. Dollars
Accumulated
Other
Comprehensive
Additional
(Loss)
Income -
Paid-in
Accumulated
Foreign
Note
Common Shares
Capital
Deficit
Exchange
Total
#
$
$
$
$
$
Balance June 30, 2020
5,220,707
53,065,240
17,764,333
( 64,649,381 )
( 301,874 )
5,878,318
Loss and comprehensive income for the period
-
-
-
( 1,599,079 )
129,400
( 1,469,679 )
Share-based compensation
8
-
-
85,407
-
-
85,407
Balance September 30, 2020
5,220,707
53,065,240
17,849,740
( 66,248,460 )
( 172,474 )
4,494,046
Accumulated
Other
Comprehensive
Additional
Income -
Paid-in
Accumulated
Foreign
Note
Common Shares
Capital
Deficit
Exchange
Total
#
$
$
$
$
$
Balance June 30, 2021
8,050,707
60,587,417
21,513,051
( 74,852,470 )
128,569
7,376,567
Private placement
7
890,000
1,459,051
10,540,635
-
-
11,999,686
Share issuance costs
7
-
( 247,336 )
( 1,786,831 )
-
-
( 2,034,167 )
Agents’ warrants
-
-
739,920
-
-
739,920
Exercise of pre-funded warrants
7
1,386,327
1,887,592
( 1,887,453 )
-
-
139
Loss for the period
-
-
-
( 2,971,615 )
-
( 2,971,615 )
Share-based compensation
8
-
-
111,142
-
-
111,142
Balance September 30, 2021
10,327,034
63,686,724
29,230,464
( 77,824,085 )
128,569
15,221,672
The accompanying notes form an integral part of these condensed consolidated interim financial statements.
5
InMed
Pharmaceuticals Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS (unaudited)
For
the three months ended September 30, 2021 and 2020
Expressed in U.S. Dollars
Note
2021
2020
Cash provided by (used in):
$
$
Operating Activities
Net loss for the period
( 2,971,615 )
( 1,599,079 )
Items not requiring cash:
Amortization and depreciation
4, 5
28,532
27,981
Share-based compensation
8
111,142
85,407
Non-cash lease expense
25,906
20,728
Interest income (accrued) received on short-term investments
( 23 )
140
Unrealized foreign exchange gain
1,262
-
Payments on lease obligations
( 17,411 )
( 16,244 )
Changes in non-cash working capital:
Prepaids and other assets
634,410
( 31,681 )
Other non-current assets
6,030
( 14,007 )
Accounts receivable
( 2,923 )
( 5,554 )
Accounts payable and accrued liabilities
( 469,227 )
160,719
Total cash used in operating activities
( 2,653,917 )
( 1,371,590 )
Investing Activities
Loan receivable
3
( 250,000 )
-
Total cash used in investing activities
( 250,000 )
-
Financing Activities
Shares issued for cash
7
11,999,825
-
Share issuance costs
7
( 1,115,129 )
( 64,648 )
Total cash provided by (used in) financing activities
10,884,696
( 64,648 )
Effects of foreign exchange on cash and cash equivalents
-
127,725
Increase (decrease) in cash during the period
7,980,779
( 1,308,513 )
Cash and cash equivalents beginning of the period
7,363,126
5,805,809
Cash and cash equivalents end of the period
15,343,905
4,497,296
Supplemental disclosure of non-cash financing activities:
Warrants issued to placement agent and included in share issuance costs related to July 2021 private placement
739,920
-
See
Note 11 for Non-Cash Transactions
The accompanying notes form an integral part of these condensed consolidated interim financial statements
6
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
1. CORPORATE
INFORMATION AND CONTINUING OPERATIONS
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 specializing in
the research and development of novel, cannabinoid-based therapies and a system for the manufacturing of pharmaceutical-grade cannabinoids.
The
Company’s shares are listed on the Nasdaq Capital Market (“Nasdaq”) under the trading symbol “INM”. InMed’s
corporate office and principal place of business is located at #310 – 815 West Hastings Street, Vancouver, B.C., Canada, V6C 1B4.
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 condensed consolidated interim financial statements are issued.
Through
September 30, 2021, 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 $ 3.0 million and $ 1.6 million for
the three months ended September 30, 2021 and 2020, respectively. In addition, the Company had an accumulated deficit of $ 77.8 million
as of September 30, 2021 (June 30, 2021 - $ 74.9 million). The Company expects to continue to generate operating losses for the foreseeable
future.
As of the issuance date of these condensed
consolidated interim financial statements, the Company expects its cash and cash equivalents of $ 15.3 million as of September 30, 2021
will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of fiscal 2023. The future
viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations. As a result,
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 interim 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
stockholders.
These
condensed consolidated interim financial statements have been prepared on a going concern basis, which assumes that the Company will
be able to meet its commitments, realize its assets and discharge its liabilities in the normal course. These condensed consolidated
interim financial statements do not reflect adjustments to the carrying values of assets and liabilities that would be necessary if the
Company was unable to continue as a going concern and such adjustments could be material.
7
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
2. SIGNFICANT
ACCOUNTING POLICIES
(a) Basis of Presentation
These
unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting principles
as applied in the United States (“US GAAP”) and pursuant to the rules and regulations of the United States Securities and
Exchange Commission (“SEC”) for interim 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 year ended June 30, 2021.
These unaudited condensed consolidated
interim financial statements reflect all adjustment, 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 ended
September 30, 2021 and 2020 are not necessarily indicative of results that can be expected for a full year. These unaudited condensed
consolidated interim 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 year ended June 30, 2021.
The
functional currency of the Company and its subsidiaries is the U.S. Dollar. These condensed consolidated interim 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.
(b) Use of Estimates
The
preparation of financial statements in compliance with US 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 interim financial statements are the estimate of useful life of intangible
assets, the application of the going concern assumption, the impairment assessment for long-lived assets, and determining the fair value
of share-based payments and warrants.
COVID-19
impacts
On
March 11, 2020 the COVID-19 outbreak was declared a pandemic by the World Health Organization. The full extent to which the COVID-19
pandemic may directly or indirectly impact the Company’s business, results of operations and financial condition, including expenses,
research and development costs and employee-related amounts, will depend on future developments that are evolving and highly uncertain,
such as the duration and severity of outbreaks, including potential future waves or cycles, and the effectiveness of actions taken to
contain and treat COVID-19. The Company considered the potential impact of COVID-19 when making certain estimates and judgments relating
to the preparation of these condensed consolidated interim financial statements. While there was no material impact to the Company’s
condensed consolidated interim financial statements as of and for the three months ended September 30, 2021, the Company’s
future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in a material impact to the Company’s
consolidated financial statements in future reporting periods.
8
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
2. SIGNFICANT
ACCOUNTING POLICIES (cont’d)
(c) Recent Accounting Pronouncements Not Yet Adopted
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.
3. LOAN
RECEIVABLE
On September 25, 2021, the Company
provided a short-term loan to BayMedica Inc. (“BayMedica”) of $ 250,000 (June 30, 2020 - $ Nil ). The loan, which is secured
against certain BayMedica assets, bears no interest unless the proposed acquisition of BayMedica is terminated in accordance with the
InMed BayMedica Reorganization Agreement in which case interest accrues at a rate of 15 % per annum from date of issuance. The loan matures
within one year . On October 13, 2021, the Company acquired BayMedica (see Note 14).
4. PROPERTY
AND EQUIPMENT, NET
Property
and equipment consists of the following:
September 30,
2021
June
30,
2021
$
$
Right of Use Asset
(lease)
439,321
439,321
Equipment
66,888
66,888
Leasehold
Improvements
42,986
42,986
Property
and equipment
549,195
549,195
Less:
accumulated depreciation
( 244,261 )
( 222,600 )
Property
and equipment, net
304,934
326,595
Depreciation
expense on property, equipment and leasehold improvements for the three months ended September 30, 2021 was $ 4,217 (2020 - $ 6,384 ). Depreciation
expense related to the Right-of-Use Asset for the three months ended September 30, 2021 was $ 21,343 (2020 - $ 21,351 ) and was recorded
in general and administrative expenses.
5. INTANGIBLE
ASSETS, NET
Intangible
assets consist of:
September 30, 2021
June 30,
2021
$
$
Intellectual property
1,736,420
1,736,420
Less: accumulated amortization
( 699,038 )
( 674,723 )
Intangible assets, net
1,037,382
1,061,697
The
acquired intellectual property is recorded at cost and is amortized on a straight-line basis over an estimated useful life of 18 years
net of any accumulated impairment losses. As at September 30, 2021, the acquired intellectual property had an estimated remaining useful
life of approximately 10.9 years.
9
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
5. INTANGIBLE ASSETS, NET (cont’d)
Amortization
expense on intangible assets for the three months ended September 30, 2021 was $ 24,315 (2020 - $ 21,597 ). Based upon the intangible assets
held as at September 30, 2021, the Company expects amortization expense to be incurred over the next five years as follows:
$
2022
96,468
2023
96,468
2024
96,468
2025
96,468
2026
96,468
482,340
6. ACCOUNTS
PAYABLE AND ACCRUED LIABILITIES
Accounts
payable and accrued liabilities consist of the following:
September 30, 2021
June 30,
2021
$
$
Trade payables
1,255,946
775,129
Accrued research and development expenses
178,117
309,901
Employee compensation, benefits and related accruals
273,154
880,207
Accrued general and administrative expenses
137,552
169,641
Accounts payable and accrued liabilities
1,844,769
2,134,878
7. SHARE
CAPITAL AND RESERVES
a) Authorized
As at September 30, 2021, 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 at September 30, 2021 and June 30, 2021.
The
Company may issue preferred shares and may, at the time of issuance, determine the rights, preference 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.
10
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
7. SHARE CAPITAL AND RESERVES (cont’d)
b) Common
Shares
During
the three months ended September 30, 2021, the Company completed the following:
Transaction Description
Number
Issue Price
Total
Private placement – Shares
890,000
$ 2.973
$ 2,645,970
Private placement - Pre-funded warrants
3,146,327
$ 2.9729
9,353,716
Gross Proceeds
$ 11,999,686
Allocated to Additional Paid-in Capital
( 10,540,635 )
$ 1,459,051
Share issuance costs
-
$ -
$ ( 247,336 )
On July 2, 2021, the Company closed
a private placement of its common shares and issued an aggregate of 890,000 common shares and 3,146,327 pre-funded warrants, for gross
proceeds of $ 11,999,686 . The pre-funded warrants were determined to be common stock equivalents. Each common share and each pre-funded
warrant was sold in the offering with a warrant to purchase a common share. Transaction costs were allocated proportionally between common
shares and warrants with $ 247,336 allocated to common shares and the balance of $ 1,786,831 allocated to additional paid-in capital and
recorded as a component of shareholders’ equity in the consolidated balance sheet.
c) Share
Purchase Warrants
On
November 16, 2020, 1,780,000 warrants were issued with an exercise price of $ 5.11 per share, were immediately exercisable upon issuance,
and expire 6 years following the date of issuance.
On
February 12, 2021, 693,000 warrants were issued with an exercise price of $ 4.85 per share, were exercisable 6 months following issuance,
and expire 5.5 years following the date of issuance.
On
July 2, 2021, 4,036,327 warrants were issued with an exercise price of $ 2.848 per share, were immediately exercisable upon issuance,
and expire 5 years following the date of issuance. The pre-funded and common warrants did not meet the criteria to be classified as a
liability award and therefore were treated as an equity award and recorded as a component of shareholders’ equity in the consolidated
balance sheets.
The following is a summary of changes
in share purchase warrants from July 1, 2021 to September 30, 2021:
Number
Weighted
Average
Share Price
Aggregate
Intrinsic
Value
Balance as at June 30, 2021
2,473,000
$
5.04
-
Granted
4,036,327
$
2.848
-
Balance as at September 30, 2021
6,509,327
$
3.68
-
11
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
7. SHARE
CAPITAL AND RESERVES (cont’d)
d) Agents’
Warrants
On
July 2, 2021, 302,725 warrants were issued for services with an exercise price of $ 3.7163 per share, were immediately exercisable upon
issuance, and expire 5 years following the date of issuance. The agents’ warrants did not meet the criteria to be classified as
a liability award and therefore were treated as an equity award and recorded as a component of shareholders’ equity in the consolidated
balance sheet.
The following is a summary of changes
in agents’ warrants from July 1, 2021 to September 30, 2021:
Number
Weighted Average
Share Price
Aggregate
Intrinsic
Value
Balance as at June 30, 2021
-
-
-
Granted
302,725
$
3.7163
-
Balance as at September 30, 2021
302,725
$
3.7163
-
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 Board of Directors may, from time to time, in its discretion and in accordance with
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 new
stock option 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.
As at September 30, 2021, there were
132,137 (June 30, 2021 – 493,387 ) options available for future allocation pursuant to the terms of the Plan. The option price under
each option shall be 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, typically 12 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 (United States dollar amounts for weighted average
exercise prices and aggregate intrinsic value are calculated using prevailing rates as at September 30, 2021). Commencing in May 2021,
stock options are granted with United States dollar exercise prices.
12
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
8. SHARE-BASED
PAYMENTS (cont’d)
a) Option
Plan Details (cont’d)
The following is a summary of changes
in outstanding options from July 1, 2021 to September 30, 2021:
Number
Weighted
Average
Exercise
Price
Balance as at June 30, 2021
912,006
$ 8.61
Balance as at September 30, 2021
912,006
$ 8.38
September 30, 2021:
Vested and exercisable
615,625
$ 10.90
Unvested
296,381
$ 3.17
b) Fair
Value of Options Issued During the Period
i) Weighted
Average Fair Value at Grant Date of Options Granted:
There
were no options granted during the three months ended September 30, 2021.
The
weighted average fair value at grant date of options granted during the year ended June 30, 2021 was $ 1.96 per option. Assumptions used
for options granted during the year ended June 30, 2021 included a weighted average risk-free interest rate of 0.27 %, weighted average
expected life of 3.2 years calculated using the Simplified Method for directors, officers and employees and the contractual life for
consultants, weighted average volatility factor of 105.88 %, weighted average dividend yield of 0 % and a 5 % forfeiture rate.
ii) Expenses
Arising from Share-based Payment Transactions:
Total
expenses arising from share-based payment transactions recognized during the three months ended September 30, 2021 were $ 111,142 (2020
- $ 85,407 ). $ 81,009 was allocated to general and administrative expenses (2020 - $ 47,850 ) and the remaining $ 30,133 was allocated to
research and development expenses (2020 - $ 37,557 ). Unrecognized compensation cost at September 30, 2021 related to unvested options
was $ 247,519 which will be recognized over a weighted-average vesting period of 1.2 years.
9. LEASE
OBLIGATIONS
On
commencement of the lease for the Company’s new offices premises on July 1, 2019, the Company recognized right-of-use assets of
$ 434,660 and a lease liability of $ 385,057 with no net impact on accumulated deficit.
The
following table lists the Company’s operating lease obligations recognized on commencement of the lease for the Company’s
offices premises at July 1, 2019.
Lease obligations recognized as at July 1, 2019
$ 385,057
Discounted using the incremental borrowing rate at July 1, 2019
8 %
Estimated annual variable lease payments not included in lease obligations
$ 59,983
13
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
9. LEASE OBLIGATIONS (cont’d)
The Company is committed to minimum
lease payments as follows:
Maturity Analysis
September 30,
2021
Less than one year
$ 158,452
One to five years
309,592
More than five years
-
Total undiscounted lease liabilities
$ 468,044 (1)
(1) Excludes estimated variable operating costs of $ 61,615 on an
annual basis through to August 31, 2024.
10. BASIC AND DILUTED LOSS PER SHARE
Basic loss per share
amounts are calculated by dividing the net loss for the period by the weighted average number of ordinary shares outstanding during the
period. The pre-funded warrants were determined to be common stock equivalents and have been included in the weighted average number of
shares outstanding for calculation of the basic earnings per share number. As the outstanding stock options and warrants are anti-dilutive,
they are excluded from the weighted average number of common shares in the table below.
Three Months Ended
September 30
2021
2020
$
$
Net loss for the period
( 2,971,615 )
( 1,599,079 )
Basic and diluted loss per share
( 0.25 )
( 0.31 )
Weighted average number of common shares - basic and diluted
12,047,555
5,220,707
11. NON-CASH TRANSACTIONS
Investing and financing activities
that do not have a direct impact on cash flows are excluded from the statements of cash flows. During the three months ended September
30, 2021, the following transaction was excluded from the statement of cash flows:
i) On July 2, 2021, the Company issued warrants to its placement agent. The fair value of these warrants was $ 739,920 and was included
in share issuance costs related to the July 2021 private placement.
ii) As at September 30, 2021, the Company has unpaid financing costs of
$ 179,118 .
During the three months ended September
30, 2020, the following transaction was excluded from the statement of cash flows:
i) As at September 30, 2020, the Company has unpaid financing costs
of $ 171,717 .
14
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
12. COMMITMENTS AND CONTINGENCIES
Pursuant to the terms
of agreements with various contract research organizations, as at September 30, 2021, the Company is committed for contract research services
and materials at a cost of approximately $ 3,071,450 , expected to occur in the twelve months following September 30, 2021.
Pursuant to the
terms of a May 31, 2017 Technology Assignment 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 agreement. To date, no payments have been required to be made.
Pursuant to the terms
of a December 13, 2018 Collaborative Research Agreement with UBC in which the Company owns all right, title and interest 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, no payments have been required to be made.
Pursuant to the terms
of a November 1, 2018 Contribution Agreement with 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 a face value of $ 45,132 (June 30, 2021 - $ 46,391 ) that are pledged as security for a corporate
credit card.
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 limits the Company’s 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.
In July 2020, in
connection with the IPO of our common shares, two inadvertent disclosures of already publicly available information were made that may
have exceeded the scope permissible under Rule 134 of the Securities Act of 1933, and thus may not be entitled to the “safe-harbor”
provided by Rule 134. As a result, either of the two inadvertent disclosures could be determined to not be in compliance for a registered
securities offering under Section 5 of the Securities Act of 1933. If either of the two inadvertent disclosures are determined by a court
to be a violation by the Company of the Securities Act of 1933, the recipients of the inadvertent disclosures who purchased our common
shares in the IPO may have a rescission right, which could require the Company to repurchase those shares at their original purchase price
with interest or a claim for damages if the purchaser no longer owns the securities, for one year following the date of the violation.
The Company could also incur considerable expense if it were to contest any such claims. Consequently, a contingent liability may arise
out of this possible violation of the Securities Act of 1933. The likelihood and magnitude of this contingent liability, if any, is not
determinable at this time.
Pursuant to a technology
licensing agreement, the Company is committed to issue, subject to regulatory approval, up to 17,500 warrants to purchase 17,500 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 for issuance date.
15
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
12. COMMITMENTS AND CONTINGENCIES (cont’d)
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.
13. FINANCIAL RISK MANAGEMENT
The Company’s financial instruments
consist of cash and cash equivalents, short-term investments, accounts receivable and accounts payable and accrued liabilities.
The fair values of short-term investments,
accounts receivable, and accounts payable and accrued liabilities approximate their carrying values because of the short-term nature of
these instruments. Cash and cash equivalents are measured at fair value using Level 1 inputs.
a) Market Risk:
Market risk is the risk that the fair
value of future cash flows of a financial instrument will fluctuate because of changes in market prices. Market prices are comprised of
four types of risk: foreign currency risk, interest rate risk, commodity price risk and equity price risk. The Company does not currently
have significant commodity price risk or equity price risk.
Foreign Currency Risk :
Foreign currency risk is the risk
that the future cash flows or fair value of the Company’s financial instruments that are denominated in a currency that is not the
Company’s functional currency (U.S. dollar) will fluctuate due to changes in foreign exchange rates. Portions of the Company’s
cash and cash equivalents and accounts payable and accrued liabilities are denominated in Canadian dollars.
Accordingly, the Company is exposed
to fluctuations in exchange rates, primarily against the Canadian dollar.
As at September 30, 2021, the Company
has a net excess of Canadian dollar denominated cash and cash equivalents in excess of Canadian dollar denominated accounts payable and
accrued liabilities of C$ 2,443,919 which is equivalent to US$ 1,918,232 at the September 30, 2021 exchange rate. The Canadian dollar financial
assets generally result from holding Canadian dollar cash to settle anticipated near-term accounts payable and accrued liabilities denominated
in Canadian dollars. The Canadian dollar financial liabilities generally result from purchases of supplies and services from suppliers
in Canada.
Each change of 1 % in the Canadian dollar
in relation to the U.S. dollar results in a gain or loss, with a corresponding effect on cash flows, of $ 19,182 based on the September
30, 2021 net Canadian dollar assets (liabilities) position. During the three months ended September 30, 2021, the Company recorded foreign
exchange loss of $ 83,800 (2020 – $ Nil ) related to Canadian dollars.
16
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
13. FINANCIAL RISK MANAGEMENT (cont’d)
a) Market Risk (cont’d):
Interest Rate Risk:
Interest rate risk is the risk that
future cash flows will fluctuate as a result of changes in market interest rates. As at September 30, 2021, holdings of cash and cash
equivalents of $ 7,109,169 (June 30, 2021 - $ 7,053,329 ) are subject to floating interest rates. The balance of the Company’s cash
holdings of $ 8,234,736 (June 30, 2021 - $ 309,796 ) are non-interest bearing.
As at September 30, 2021, the Company
held variable rate guaranteed investment certificates, with one-year terms, with face value of $ 45,132 (June 30, 2021 - $ 46,391 ).
The Company’s current policy
is to invest excess cash in guaranteed investment certificates or interest-bearing accounts of major Canadian chartered banks or credit
unions with comparable credit ratings. The Company regularly monitors compliance to its cash management policy.
b) Credit Risk:
Credit risk is the risk of financial
loss to the Company if a customer or a counter party to a financial instrument fails to meet its contractual obligations. Financial instruments
which are potentially subject to credit risk for the Company consist primarily of cash and cash equivalents, short-term investments and
loan receivable. Cash and cash equivalents and short-term investments are maintained with financial institutions of reputable credit and
may be redeemed upon demand. In the normal course of business, the Company does not provide third party loans. The loan receivable as
at September 30, 2021 was issued in conjunction with the planned acquisition of the payee, BayMedica, Inc. (see Note 14).
The carrying amount of financial assets
represents the maximum credit exposure. Credit risk exposure is limited through maintaining cash and cash equivalents and short-term investments
with high-credit quality financial institutions and management considers this risk to be minimal for all cash and cash equivalents and
short-term investments assets based on changes that are reasonably possible at each reporting date.
c) Liquidity Risk:
Liquidity risk is the risk that the
Company will not be able to meet its financial obligations as they become due. The Company’s policy is to ensure that it has sufficient
cash to meet its liabilities when they become due, under both normal and stressed conditions, without incurring unacceptable losses or
risking damage to the Company’s reputation. A key risk in managing liquidity is the degree of uncertainty in the cash flow projections.
If future cash flows are fairly uncertain, the liquidity risk increases. As at September 30, 2021, the Company has cash and cash equivalents
and short-term investments of $ 15,389,129 (June 30, 2021 - $ 7,409,588 ), current liabilities of $ 1,927,001 (June 30, 2021 - $ 2,215,361 )
and a working capital surplus of $ 14,049,322 (June 30, 2021 - $ 6,162,908 ).
17
INMED PHARMACEUTICALS INC.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
(Expressed in U.S. Dollars)
14. SUBSEQUENT EVENTS
On October 13, 2021, the Company completed
the previously announced acquisition of BayMedica, a private company based in the U.S. that specializes in the manufacturing and commercialization
of rare cannabinoids. The Company acquired 100 % of BayMedica in exchange for 2.05 million common shares issued to BayMedica’s equity
and convertible debt holders, subject to a six-month contractual hold period and $ 1 million to be held in escrow, subject to cancellation,
to satisfy certain potential post-closing indemnification and other claims that InMed may have under the definitive agreement in the six-
and twelve-month periods following the closing.
Subsequent to September
30, 2021, the Company provided an additional $ 175,000 short-term loan to BayMedica on terms similar to the September 25, 2021 loan.
18
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on Form 10-Q 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” or “InMed”) 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”, and similar expressions that convey uncertainty of future events or outcomes to identify these
forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking
statements. Forward-looking statements in this Form 10-Q include, but are not limited to, statements about:
●
Our researching, developing, manufacturing and commercializing cannabinoid-based biopharmaceutical products will treat diseases with high unmet medical needs;
●
Bringing strict scientific discipline to the field of cannabinoid medicine to unlock the full potential of this class of drugs;
●
Our ability to register and commercialize products in the United States and other jurisdictions;
●
The future timing of INM-755 and INM-088 studies;
●
Our ability to source cannabinoids from third-party manufacturers;
●
Our ability to successfully integrate and develop
BayMedica’s operations;
●
Our ability to successfully develop and scale-up our IntegraSyn™ approach;
●
Our ability to transfer our integrative biosynthesis-based manufacturing approach to a contract development and manufacturing organization, or “CDMO”;
●
Our ability to deliver our rare cannabinoid pharmaceuticals through various topical formulations (cream for dermatology, eye drops for ocular diseases);
●
Our ability to minimize systemic exposure and any related unwanted systemic side effects, including any drug-drug interactions and any metabolism of the active pharmaceutical ingredient by the liver;
●
Our ability to continue research on INM-755, our lead drug candidate for the treatment of EB, by completing the ongoing clinical trials and commencing subsequent clinical trials;
●
Our ability to continue preclinical research studies for INM-088, our drug candidate for the treatment of glaucoma, which we expect to be followed by clinical trial-enabling studies and then human clinical trials;
●
Our ability to investigate our Product Candidates for additional indications;
●
Our ability to pursue the discovery of drug targets for other diseases with high unmet medical needs and the subsequent development of any resulting Product Candidates;
●
Our ability to seek regulatory approvals for any Product Candidates that successfully complete clinical trials;
●
Our ability to scale-up our manufacturing processes and capabilities, or arrange for a third party to do so on our behalf, to support our clinical trials of our Product Candidates and commercialization of any of our Product Candidates for which we obtain marketing approval;
19
●
Acquiring or in-licensing externally developed product(s) and/or technologies;
●
Maintaining, expanding, enforcing, defending and protecting our intellectual property;
●
Our ability to hire additional clinical, quality control and scientific personnel;
●
Our ability to add operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts and our operations as a public company; and
●
Our ability to finance our operations through the sale of equity, debt financings or other capital sources, including collaborations with other companies or other strategic transactions;
This list is not exhaustive of the factors that
may affect our forward-looking statements. Some of the important risks and uncertainties that could affect forward-looking statements
are described further under the section heading: Item 2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations of this 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.
20
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Three Months Ended
September 30, 2021
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 our Annual Report on Form 10-K, dated September 24,
2021. 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 interim financial statements for the three months ended September 30,
2021, 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 our Form 10-K filing. Throughout
this discussion, unless the context specifies or implies otherwise, the terms “InMed,” “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 prescription-based products targeting treatments for diseases with high unmet medical needs as well as developing
proprietary manufacturing technologies.
21
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
We are developing an integrated biosynthesis-based
manufacturing approach, called IntegraSyn TM , for synthesizing pharmaceutical-grade cannabinoids, for potential use in product
candidates. IntegraSyn TM , together with our prescription-based products are referred to as our “Product Candidates.”
We are dedicated to delivering new therapeutic alternatives to patients who may benefit from cannabinoid-based pharmaceuticals. Our approach
leverages on the several thousand years’ history of health benefits attributed to the Cannabis plant and brings this anecdotal
information into the 21st century by applying tried, tested and true pharmaceutical drug development discipline and a scientific approach
to establish non-plant-derived (synthetically manufactured), individual cannabinoid compounds as clinically proven, FDA-approved medicines.
While our activities do not involve direct use of Cannabis nor extracts from the plant, we note that the U.S. Food and Drug Administration
(“FDA”) has, to date, not approved any marketing application for Cannabis for the treatment of any disease or condition
and has approved only one Cannabis -derived and three Cannabis -related drug products. Our APIs, which are the ingredients
that give medicines their effects, are synthetically made and, therefore, we have no interaction with the Cannabis plant. We do
not grow nor utilize Cannabis nor its extracts in any of our products; our products are applied topically (not inhaled nor ingested);
and we do not utilize THC or CBD, the most common cannabinoid compounds that are typically extracted from the Cannabis plant, in
any of our products. The API under development for our initial two drug candidates, INM-755 for epidermolysis bullosa (“EB”)
and INM-088 for glaucoma, is cannabinol (“CBN”). Additional uses of both INM-755 and INM-088 are being explored, as well as
the application of additional rare cannabinoids to treat diseases.
We believe we are positioned to develop multiple
product candidates in diseases which may benefit from medicines based on rare cannabinoid compounds. Most currently approved cannabinoid
therapies are based specifically on cannabidiol (“CBD”) and/or tetrahydrocannabinol (“THC”) and are often delivered
orally, which has limitations and drawbacks, such as side effects (including the intoxicating effects of THC). Currently, we intend to
deliver our rare cannabinoid pharmaceuticals through various topical formulations, including through cream for dermatology and eye drops
for ocular diseases, as a way of enabling treatment of the specific disease at the site of disease while seeking to minimize systemic
exposure and any related unwanted systemic side effects. THC and CBD can be obtained either from plant extraction or chemically synthesized.
We plan to access rare cannabinoids via all non-extraction approaches, including our IntegraSyn TM approach, thus negating any
interaction with or exposure to the Cannabis plant.
Since our acquisition of Biogen Sciences Inc.,
a privately held British Columbia pharmaceutical company focused on drug discovery and development of cannabinoids in 2014, our operations
have 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. To date,
we have funded our operations primarily through the issuance of common shares.
We have incurred significant operating losses
since our inception and since the acquisition of Biogen Science Inc. and we expect to continue to incur significant operating losses for
the foreseeable future. Our ability to generate product revenue, if ever, that is sufficient to achieve profitability will depend heavily
on the successful development and eventual commercialization of one or more of our drug candidates and/or our integrated, biosynthesis-based
manufacturing technology. Our comprehensive loss was $3.0 million and $1.5 million for the three months ended September 30, 2021 and 2020,
respectively. As of September 30, 2021, we had an accumulated deficit of $77.8 million, which includes all losses since our inception
in 1981. Our accumulated deficit increased between 2014, when we began focusing on the development of cannabinoid-derived pharmaceuticals
following the acquisition of Biogen Science Inc., and September 30, 2021 by approximately $49.0 million. We expect our expenses and operating
losses will increase substantially over the next several years in connection with our ongoing activities as we:
●
continue to further advance the development of our IntegraSyn™ manufacturing approach;
●
continue to further advance the INM-755 program, our lead drug candidate for the treatment of EB;
22
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
●
continue to further advance the INM-088 program, our drug candidate for the treatment of glaucoma;
●
investigate our Product Candidates for additional uses beyond the initial indications;
●
pursue the discovery of drug targets 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, to support our clinical trials of our Product Candidates and commercialization of any of our Product Candidates for which we obtain marketing approval;
●
execute on business development activities, including but not limited to company mergers/acquisitions and acquisition or in-licensing of externally developed products and/or technologies;
●
maintain, expand, enforce, defend and protect our intellectual property;
●
hire additional clinical, quality control and scientific personnel; and
●
add operational, financial and management information
systems and personnel, including personnel to support our product development and potential future commercialization efforts and our operations
as a public company.
As a result, we will need substantial additional
funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from
product sales, if ever, we expect to finance our operations through 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, or 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
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 Product Candidates ourselves.
Because of the numerous risks and uncertainties
associated with drug development, we are unable to predict the timing or amount of increased expenses or the timing of when or if we will
be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail
to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at
planned levels and be forced to reduce or terminate our operations.
On July 2, 2021, we closed a $12.0 million private
placement. After deducting the placement agent fees and estimated offering expenses payable by the Company, the Company received net proceeds
of approximately $11.0 million.
On October 13, 2021, we completed the acquisition
of BayMedica Inc. (“BayMedica”), a private company based in the U.S. that specializes in the manufacturing and commercialization
of rare cannabinoids. We acquired 100% of BayMedica in exchange for 2.05 million common shares issued to BayMedica’s equity and
convertible debt holders, subject to a six-month contractual hold period and $1 million to be held in escrow, subject to cancellation,
to satisfy certain potential post-closing indemnification and other claims that the Company may have under the definitive agreement in
the six- and twelve-month periods following the closing.
23
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
Components of Results of Operations
Revenue
We have not generated any revenue from product
sales and do not expect to generate any revenue from the sale of products for several years, if at all. If our development efforts for
our current or future Product Candidates are successful and result in marketing approval, we may generate revenue in the future from product
sales. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of our Product Candidates.
We may never succeed in obtaining regulatory approval for any of our Product Candidates.
We may also, in the future, conduct merger/acquisition
activities with other company, or acquire or in-license externally developed products and/or technologies which may generate revenue.
We may enter into license or collaboration agreements for our Product Candidates or intellectual property and we may generate revenue
in the future from payments as a result of such license or collaboration agreements.
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 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 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 expense. We do not track our internal research and development expenses on a program-by-program basis as the resources are
deployed across multiple projects.
24
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
The successful development of our 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 necessary to complete the remainder of the development of our Product Candidates. 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 developing our Product Candidates, including the uncertainty 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 and to advance the development of our biosynthesis-based manufacturing technology;
●
our ability to maintain our current research and development programs and to establish new ones;
●
our ability to establish 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;
●
the receipt and related terms of regulatory approvals from applicable regulatory authorities;
●
the availability of raw materials and API for use in production of our 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;
● 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
● a continued acceptable safety profile of our products 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 Product Candidates would significantly change the costs and timing associated with the development
of that product candidate, and potentially other candidates.
25
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
Research and development activities account for
a significant portion of our operating expenses. 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 IntegraSyn™ manufacturing approach to commercial
scale and our drug candidates 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 integrating and developing BayMedica’s operations. 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.
General and Administrative Expenses
General and administrative expenses consist of
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, investor relations activities, legal fees related
to corporate matters, fees paid for accounting and tax services, consulting fees and facility-related costs.
We expect our general and administrative expenses
will increase for the foreseeable future to support our expanded infrastructure, operating as a public company and increased costs of
expanding our operations including as a consequence of the BayMedica acquisition. These increases will likely include increased expenses
related to accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing
and SEC requirements, director and officer insurance premiums, and investor relations costs associated with operating as a public company.
Amortization and Depreciation
Intangible assets are comprised of intellectual
property that we acquired in 2014 and 2015. The intellectual property is recorded at cost and is amortized on a straight-line basis over
an estimated useful life of 18 years net of any accumulated impairment losses. 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.
26
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
Other Income
Other income consists primarily of interest income
earned on our cash, cash equivalents and short-term investments.
Results of Operations
Comparison of the three months ended September
30, 2021 and 2020
Three Months Ended
September 30,
2021
2020
Change
% Change
(in thousands)
Operating expenses:
Research and development and patents
$ 1,491
$ 911
$ 580
64 %
General and administrative
1,373
625
748
120 %
Amortization and depreciation
29
28
1
4 %
Total operating expenses
2,893
1,564
1,329
85 %
Interest income
5
4
1
25 %
Foreign exchange loss
(84 )
(39 )
(45 )
115 %
Net loss
$ (2,972 )
$ (1,599 )
$ (1,373 )
86 %
Research and Development and Patents Expenses
Research and development and patents expenses
increased by $0.6 million, or 64%, for the three months ended September 30, 2021 compared to the three months ended September 30, 2020.
The increase in research and development and patents expenses was primarily due to increased activities related to the INM-755 clinical
trials.
General and administrative expenses
General and administrative expenses increased
by $0.7 million, or 120%, for the three months ended September 30, 2021 compared to the three months ended September 30, 2020. The increase
results primarily from a combination of changes including substantially higher insurance fees resulting from our listing on the Nasdaq
Capital Market, personnel expenses, legal fees and investor relation expenses.
Liquidity and Capital Resources
Since our inception, we have not generated any
revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations.
We 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 common shares.
As of September 30, 2021, we had cash and cash
equivalents of $15.3 million.
27
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
The following table summarizes our cash flows
for each of the periods presented:
(in thousands)
Three Months
Ended
September 30,
2021
Three Months
Ended
September 30,
2020
Net cash used in operating activities
$ (2,654 )
$ (1,372 )
Net cash used in investing activities
(250 )
-
Net cash provided by (used in) financing activities
10,885
(65 )
Effects of foreign exchange on cash and cash equivalents
-
128
Net increase (decrease) in cash and cash equivalents
$ 7,981
$ (1,309 )
Operating Activities
During the three months ended September 30, 2021,
we used cash in operating activities of $2.7 million, primarily resulting from our net loss of $3.0 million combined with $0.2 million
used in changes in our non-cash working capital, partially offset primarily by non-cash share-based compensation expenses and the component
of our financing expenses allocated to warrants.
During the three months ended September 30, 2020,
we used cash in operating activities of $1.4 million, primarily resulting from our net loss of $1.6 million offset primarily by non-cash
share-based compensation expenses and changes in our non-cash working capital.
Investing Activities
During the three months ended September 30, 2021,
we used cash in investing activities of $0.3 million, resulting from a short-term loan to BayMedica.
During the three months ended September 30, 2020,
there were no investing activities.
Financing Activities
During the three months ended September 30, 2021,
cash provided by financing activities of $10.9 million consisted of $12.0 million of gross proceeds from a private placement of our common
shares, offset by transaction costs of $1.1 million.
During the three months ended September 30, 2020,
we used cash in financing activities of less than $0.1 million, resulting from transaction costs related to a public offering of our common
shares.
Funding Requirements
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 integrating and developing BayMedica’s operations. 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 the Company’s ability to continue as a going concern within one year after the date
that the condensed consolidated interim financial statements are issued.
28
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
Through September 30, 2021, we have funded our
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 $3.0 million and $1.5 million for the three months ended September 30, 2021 and
2020, respectively. In addition, the Company had an accumulated deficit of $77.8 million as of September 30, 2021. Our accumulated deficit
increased between 2014, when we began focusing on the development of cannabinoid-derived pharmaceuticals following the acquisition of
Biogen Science Inc., and September 30, 2021 by approximately $49.0 million and we expect to continue to generate operating losses for
the foreseeable future.
On July 2, 2021, we closed a $12.0 million private
placement. Under the terms of the private placement, an aggregate of 890,000 common shares and 3,146,327 pre-funded warrants, and warrants
to purchase up to an aggregate of 4,036,327 common shares, were purchased. The warrants have an exercise price of $2.848 per share, are
exercisable immediately and have a term of five years. After deducting the placement agent fees and estimated offering expenses payable
by us, we received net proceeds of approximately $11.0 million.
As of the issuance date of the condensed consolidated
interim financial statements, we expect our cash and cash equivalents of $15.3 million as of September 30, 2021 will be sufficient to
fund our operating expenses and capital expenditure requirements into the first quarter of fiscal 2023. The future viability of the Company
beyond that point is dependent on its ability to raise additional capital to finance its 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 condensed consolidated interim 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. 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 our existing stockholders.
Our funding requirements and timing and amount
of our operating expenditures will depend largely on:
●
the progress, costs and results of our Phase 2 clinical trial;
●
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 IntegraSyn™ manufacturing approach;
● the number of and development requirements for other 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 API and manufacture of our Product Candidates and the terms of such arrangements;
29
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
● the
impact of any acquired, or in-licensed, externally developed product(s) and/or technologies including those of BayMedica;
●
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
●
the costs and timing of future commercialization activities, including product manufacturing, sales, marketing and distribution, for any of our Product Candidates for which we may receive marketing approval;
●
the amount and timing of revenue, if any, received from commercial sales of our Product Candidates for which we 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; and
●
the costs to obtain, maintain, expand and protect our intellectual property portfolio.
A change in the outcome of any of these, or other
variables with respect to the development of any of our Product Candidates, could significantly change the costs and timing associated
with the development of that Product Candidate. We will need to continue to rely on additional financing to achieve our business objectives.
In addition to the variables described 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 our intellectual property rights, and regulatory protection,
in addition to other commercial costs. We cannot reasonably estimate these costs at this time.
Until such time, if ever, as we can generate substantial
product revenue, 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 equity securities, the ownership interests of our shareholders will be diluted, and the terms of these securities may include
liquidation or other preferences that 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 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, we may be required to delay, limit, reduce or
terminate development or future commercialization efforts or grant rights to develop and market Product Candidates that we would otherwise
prefer to develop and market ourselves.
Off-Balance Sheet Arrangements
During the periods presented we did not have,
and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
30
InMed Pharmaceuticals Inc.
MANAGEMENT’S DISCUSSION AND ANALYSIS
Three months
ended September 30, 2021
Critical Accounting Policies and Significant
Judgments and Estimates
We periodically review our financial reporting
and disclosure practices and accounting policies to ensure that they provide accurate and transparent information relative to the current
economic and business environment. As part of this process, we have reviewed our selection, application and communication of critical
accounting policies and financial disclosures. Management has discussed the development and selection of the critical accounting policies
with the Audit Committee of the Board of Directors and the Audit Committee has reviewed the disclosure relating to critical accounting
policies in this Management’s Discussion and Analysis.
This discussion and analysis of our financial
condition and results of operations is based on our condensed consolidated interim financial statements included as part of this report,
which have been prepared in accordance with U.S. GAAP. The preparation of our condensed consolidated interim financial statements requires
us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the revenue and expenses incurred
during the reported periods. We base estimates on our historical experience, known trends and various other factors that we believe are
reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities
that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Detailed information about our critical accounting
policies and estimates is set forth in Part II, Item 7 of our Annual Report on Form 10-K for the year ended June 30, 2021. There have
been no significant changes to these policies during the three months ended September 30, 2021.
Going Concern
Through September 30, 2021, we have funded our
operations primarily with proceeds from the sale of common shares. We have incurred recurring losses and negative cash flows from operations
since our inception, including net losses of $3.0 million and $1.6 million for the three months ended September 30, 2021 and 2020, respectively.
In addition, we have an accumulated deficit of $77.8 million as of September 30, 2021. Our accumulated deficit increased between 2014,
when we began focusing on the development of cannabinoid-derived pharmaceuticals following the acquisition of Biogen Science Inc., and
September 30, 2021 by approximately $49.0 million and we expect to continue to generate operating losses for the foreseeable future.
On July 2, 2021, we closed a $12.0 million private
placement. Under the terms of the private placement, an aggregate of 890,000 common shares and 3,146,327 pre-funded warrants, and warrants
to purchase up to an aggregate of 4,036,327 common shares were purchased. The warrants have an exercise price of $2.848 per share, are
exercisable immediately and have a term of five years. After deducting the placement agent fees and estimated offering expenses payable
by us, we received net proceeds of approximately $11.0 million.
As of the issuance date of the condensed consolidated
interim financial statements, we expect our cash and cash equivalents of $15.3 million as of September 30, 2021, will be sufficient to
fund our operating expenses and capital expenditure requirements into the first quarter of fiscal 2023. The future viability of the Company
beyond that point is dependent on its ability to raise additional capital to finance its 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 condensed consolidated interim financial statements are issued.
We expect 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, or at all. The terms of any financing may adversely affect the
holdings or the rights of our existing shareholders.
31
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 September 30, 2021, 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 September 30, 2021, 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 resulting from
a lack of resources in our finance function, as disclosed in our Annual Report on Form 10-K for the fiscal year ended June 30, 2021.
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 September 30, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
Remediation
We began implementing a remediation plan to address
the previously reported material weakness in internal control over financial reporting, described in Part II, Item 9A, “Controls
and Procedures” in our Annual Report on Form 10-K for the fiscal year ended June 30, 2021. Remediation measures include adding additional
resources in our finance function, changing certain closing reporting processes and utilizing external resources to assist with certain
financial reporting matters. The material weakness will not be considered remediated, until the applicable controls operate for a sufficient
period of time and management has concluded, through testing, that these controls are operating effectively. We expect that the remediation
of this material weakness will be completed prior to the end of fiscal year 2022. 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.
32
PART II
ITEM 1. LEGAL PROCEEDINGS.
We are not involved in any material active legal
actions. However, from time to time, we may be subject to various pending or threatened legal actions and proceedings, including those
that arise in the ordinary course of our business.
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 “Risk Factors” in our Form 10-K dated September 24, 2021 and in our Registration
Statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on July 13, 2021 (the “Registration
Statement”).
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.
None.
33
ITEM 6. EXHIBITS.
Exhibits
The following exhibits are filed as part of this
report:
Exhibit Number
Description
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
101.CAL
Inline
XBRL Taxonomy Extension – Calculations
101.DEF
Inline XBRL
Taxonomy Extension – Definitions
101.LAB
Inline XBRL
Taxonomy Extension – Labels
101.PRE
Inline XBRL
Taxonomy Extension – Presentations
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
34
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: November 10, 2021
By:
/s/ Bruce Colwill
Chief Financial Officer and
Chief Accounting Officer
35
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.