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, 2022
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 November 14, 2022, the registrant had 936,761 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
23
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
35
ITEM
4. CONTROLS AND PROCEDURES
35
PART
II – OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
36
ITEM
1A. RISK FACTORS
36
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
36
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
36
ITEM
4. MINE SAFETY DISCLOSURE
36
ITEM
5. OTHER INFORMATION
36
ITEM
6. EXHIBITS
36
SIGNATURES
37
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, 2022 and 2021
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,
2022
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
7-19
The
accompanying notes form an integral part of these condensed consolidated interim financial statements.
2
InMed
Pharmaceuticals Inc.
CONDENSED
CONSOLIDATED INTERIM BALANCE SHEETS (unaudited)
As at September 30, 2022 and June 30, 2022
Expressed
in U.S. Dollars
September 30,
June 30,
Note
2022
2022
$
$
ASSETS
Current
Cash and
cash equivalents
9,350,427
6,176,866
Short-term investments
42,125
44,804
Accounts receivable
15,169
88,027
Inventories
4
1,778,523
2,490,854
Prepaids
and other assets
356,665
797,225
Total current assets
11,542,909
9,597,776
Non-Current
Property, equipment
and ROU assets, net
5
802,369
904,252
Intangible assets, net
6
2,067,922
2,108,915
Other
assets
171,130
176,637
Total
Assets
14,584,330
12,787,580
LIABILITIES AND SHAREHOLDERS’
EQUITY
Current
Accounts payable and
accrued liabilities
7
2,362,190
2,415,265
Current portion of lease
obligations
10
404,163
404,276
Deferred revenue
15,700
-
Acquisition
consideration payable
500,000
500,000
Total current liabilities
3,282,053
3,319,541
Non-current
Lease
obligations
10
294,337
389,498
Total Liabilities
3,576,390
3,709,039
Shareholders’ Equity
Common shares, no par value, unlimited
authorized shares:
908,766 (June 30, 2022 - 650,667 ) issued and outstanding
8
72,671,392
70,718,461
Additional paid-in capital
8,
9
35,170,766
31,684,098
Accumulated deficit
( 96,962,787 )
( 93,452,587 )
Accumulated
other comprehensive income
128,569
128,569
Total
Shareholders’ Equity
11,007,940
9,078,541
Total
Liabilities and Shareholders’ Equity
14,584,330
12,787,580
Going
Concern (Note 1)
Commitments
and Contingencies (Note 14)
Related
Party Transactions (Note 16)
Subsequent
Events (Note 17)
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, 2022 and 2021
Expressed
in U.S. Dollars
Three Months Ended
September
30
Note
2022
2021
$
$
Sales
320,788
-
Cost of sales
235,034
-
Inventory write-down
4
576,772
-
Gross loss
( 491,018 )
-
Operating Expenses
Research and development
and patents
1,378,653
1,491,252
General and administrative
1,560,477
1,372,867
Amortization and
depreciation
5,
6
49,048
28,532
Total operating expenses
2,988,178
2,892,651
Other Income (Expense)
Interest and other
income
72,587
5,148
Foreign exchange
loss
( 96,791 )
( 84,112 )
Loss before income taxes
( 3,503,400 )
( 2,971,615 )
Tax expense
( 6,800 )
-
Net loss for the period
( 3,510,200 )
( 2,971,615 )
Net loss per share for the period
Basic and diluted
11
( 4.06 )
( 6.17 )
Weighted average outstanding common shares
Basic and diluted
11
865,619
481,902
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, 2022 and 2021
Expressed
in U.S. Dollars
Accumulated
Additional
Other
Paid-in
Accumulated
Comprehensive
Note
Common
Shares
Capital
Deficit
Income
Total
#
$
$
$
$
$
Balance
June 30, 2021
322,028
60,587,417
21,513,051
( 74,852,470 )
128,569
7,376,567
Private
placement
35,600
1,459,051
10,540,635
-
-
11,999,686
Share issuance
costs
-
( 247,336 )
( 1,786,831 )
-
-
( 2,034,167 )
Agents’
warrants
-
-
739,920
-
-
739,920
Exercise of pre-funded
warrants
55,453
1,887,592
( 1,887,453 )
-
-
139
Loss
for the period
-
-
-
( 2,971,615 )
-
( 2,971,615 )
Share-based
compensation
9
-
-
111,142
-
-
111,142
Balance
September 30, 2021
413,081
63,686,724
29,230,464
( 77,824,085 )
128,569
15,221,672
Accumulated
Additional
Other
Paid-in
Accumulated
Comprehensive
Note
Common
Shares
Capital
Deficit
Income
Total
#
$
$
$
$
$
Balance
June 30, 2022
650,667
70,718,461
31,684,098
( 93,452,587 )
128,569
9,078,541
Private
placement
8
90,000
410,376
5,589,570
-
-
5,999,946
Share issuance
costs
8
-
( 77,242 )
( 1,052,101 )
-
-
( 1,129,343 )
Agents’
investment options
-
-
451,897
-
-
451,897
Exercise of
pre-funded warrants
8
168,099
1,619,797
( 1,619,378 )
-
-
419
Loss
for the period
-
-
-
( 3,510,200 )
-
( 3,510,200 )
Share-based
compensation
9
-
-
116,680
-
-
116,680
Balance
September 30, 2022
908,766
72,671,392
35,170,766
( 96,962,787 )
128,569
11,007,940
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, 2022 and 2021
Expressed
in U.S. Dollars
Note
2022
2021
$
$
Cash provided by (used in):
Operating Activities
Net loss for the period
( 3,510,200 )
( 2,971,615 )
Items not requiring cash:
Amortization and
depreciation
5,
6
49,048
28,532
Share-based compensation
9
116,680
111,142
Amortization of right-of-use
assets
99,460
25,906
Interest income received
on short-term investments
( 120 )
( 23 )
Unrealized foreign
exchange loss
2,796
1,262
Inventory write-down
4
576,772
-
Payments on lease obligations
( 100,903 )
( 17,411 )
Changes in non-cash working capital:
Inventories
135,559
-
Prepaids and other
assets
440,560
634,410
Other non-current assets
5,507
6,030
Accounts receivable
72,858
( 2,923 )
Accounts payable and
accrued liabilities
( 159,260 )
( 469,227 )
Deferred
revenue
15,700
-
Total
cash used in operating activities
( 2,255,543 )
( 2,653,917 )
Investing Activities
Short-term
loan
-
( 250,000 )
Total
cash used in investing activities
-
( 250,000 )
Financing Activities
Shares issued for cash
8
6,000,365
11,999,825
Share issuance
costs
8
( 571,261 )
( 1,115,129 )
Total
cash provided by financing activities
5,429,104
10,884,696
Increase (decrease) in cash
during the period
3,173,561
7,980,779
Cash
and cash equivalents beginning of the period
6,176,866
7,363,126
Cash
and cash equivalents end of the period
9,350,427
15,343,905
See Note
13 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, 2022 AND 2021
(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 developing a pipeline
of prescription-based products, including rare cannabinoids and novel cannabinoid analogs, targeting the treatment of diseases with high
unmet medical needs. The Company also has significant know-how in developing proprietary manufacturing approaches to produce cannabinoids
for various market sectors.
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 consolidated financial statements are issued.
Through
September 30, 2022, 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 $ 3.5 million and $ 3.0
million for the three months ended September 30, 2022 and 2021, respectively. In addition, the Company had an accumulated deficit
of $ 97.0 million as of September 30, 2022 (June 30, 2022 - $ 93.5 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 $ 9.4 million as of September 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements
into the second half of fiscal 2023, and possibly into the first quarter of fiscal 2024 (being the third calendar quarter of 2023), depending
on the level and timing of realizing revenues from the sale of BayMedica inventory as well as the level and timing of the Company operating
expenses. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. As a
result of the recurring losses and requirement for cash in fiscal 2023 or the beginning of fiscal 2024, 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 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.
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, 2022 AND 2021
(Expressed
in U.S. Dollars)
2. SIGNIFICANT
ACCOUNTING POLICIES
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 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, 2022.
These
unaudited condensed consolidated interim 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 ended September 30, 2022 and 2021 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, 2022.
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.
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 consolidated financial statements are the estimate of useful life of intangible assets, the application
of the going concern assumption, and determining the fair value of share-based payments and warrants.
COVID-19
Impacts
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 consolidated 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, 2022,
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, 2022 AND 2021
(Expressed
in U.S. Dollars)
2. SIGNIFICANT
ACCOUNTING POLICIES (cont’d)
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. CUSTOMER
CONCENTRATION
The
Company had three customers during the three months ended September 30, 2022, which individually generated 10% or more of the Company’s
sales. These customers accounted for 78 % of the Company’s sales for the three months ended September 30, 2022. There were
no outstanding amounts receivable from these customers as at September 30, 2022.
4. INVENTORIES
Inventories
consisted of the following:
September 30,
2022
June
30,
2022
$
$
Raw materials
292,577
292,577
Work in process
1,210,261
1,724,851
Finished goods
275,685
473,426
Inventories
1,778,523
2,490,854
During
the three months ended September 30, 2022, inventory expensed to cost of goods sold was $ 235,034 (2021 - $ Nil ).
During
the three months ended September 30, 2022, the write-down of inventories to net realizable value was $ 576,772 (2021 - $ Nil ). Contributing
factors to the decrease in net realizable value included lower demand and downward pricing pressure.
5. PROPERTY,
EQUIPMENT AND ROU ASSETS, NET
Property,
equipment and ROU assets consisted of the following:
September 30,
2022
June
30,
2022
$
$
Right-of-Use Assets (leases)
1,167,436
1,167,436
Equipment
212,877
212,877
Leasehold Improvements
40,409
40,409
Property and equipment
1,420,722
1,420,722
Less:
accumulated depreciation and amortization
( 618,353 )
( 516,470 )
Property, equipment and
ROU assets, net
802,369
904,252
Depreciation
expense on property, equipment and leasehold improvements for the three months ended September 30, 2022, was $ 8,055 (2021 - $ 4,217 ).
Amortization expense related to the right-of-use assets for the three months ended September 30, 2022, was $ 90,244 (2021 - $ 21,343 )
and was recorded in general and administrative expenses.
9
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
6. INTANGIBLE
ASSETS
September 30,
2022
June
30,
2022
$
$
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 depreciation
( 859,498 )
( 818,505 )
Intangible assets, net
2,067,922
2,108,915
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 cannabinoid analogs. This intangible asset is being amortized over an estimated
useful life of 18 years.
As
at September 30, 2022, the definite-lived intangible assets had a weighted average estimated remaining useful life of approximately
13 years.
Amortization
expense on intangible assets for the three months ended September 30, 2022 was $ 40,993 (2021 - $ 24,315 ). The Company expects amortization
expense to be incurred over the next five years as follows:
$
2023
155,778
2024
155,778
2025
155,778
2026
155,778
2027
155,778
778,890
7. ACCOUNTS
PAYABLE AND ACCRUED LIABILITIES
Accounts
payable and accrued liabilities consist of the following:
September 30,
2022
June
30,
2022
$
$
Trade payables
1,096,212
1,166,068
Accrued research and development expenses
956,429
839,638
Employee compensation, benefits and related
accruals
249,593
139,120
Accrued general and
administrative expenses
59,956
270,439
Accounts payable and accrued
liabilities
2,362,190
2,415,265
10
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
8. SHARE
CAPITAL AND RESERVES
a) Authorized
As
at September 30, 2022, 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, 2022 and June 30, 2022.
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.
b) Common
Shares
During
the three months ended September 30, 2022, the Company completed the following:
September
2022 Private Placement Offering:
Transaction
Description
Number
Issue
Price
Total
Shares Issued
90,000
$ 8.680
$ 781,200
Pre-funded Warrants
Issued
601,245
$ 8.6799
5,218,746
Gross Proceeds
$ 5,999,946
Allocated to Additional
Paid-in Capital
( 5,589,570 )
$ 410,376
Share Issuance Costs
$ ( 77,242 )
On
September 13, 2022, the Company closed a private placement of its common shares and issued an aggregate of 90,000 common shares and 601,245
pre-funded warrants, for gross proceeds of $ 5,999,946 . The pre-funded warrants were determined to be common stock equivalents. Each common
share and each pre-funded warrant were sold in the offering with an investment option to purchase a common share. Transaction costs were
allocated proportionally between common shares and investment options with $ 77,242 allocated to common shares and the balance of $ 1,052,101
allocated to additional paid-in capital and recorded as a component of shareholders’ equity in the consolidated balance sheet.
As at September 30, 2022, there were 601,245 pre-funded warrants outstanding.
11
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
8. SHARE
CAPITAL AND RESERVES (cont’d)
c) Share
Purchase Warrants
The
following is a summary of changes in share purchase warrants from July 1, 2022 to September 30, 2022:
Number
Weighted
Average
Share Price
Aggregate
Intrinsic Value
Balance as at June 30, 2022
244,767
$ 41.99
-
Cancelled
( 179,231 )
$ 18.50
-
Balance as at September 30,
2022
65,536
$ 106.23
-
The
total intrinsic value of warrants exercised during the three months ended September 30, 2022 was $ Nil (2021 - $ Nil ).
d) Agents’
Warrants
The
following is a summary of changes in agents’ warrants from July 1, 2022 to September 30, 2022:
Number
Weighted
Average
Share Price
Aggregate
Intrinsic Value
Balance
as at June 30, 2022
12,109
$ 92.91
-
Balance as at September 30,
2022
12,109
$ 92.91
-
e) Preferred
Investment Options
On
September 13, 2022, 1,382,490 preferred investment options were issued with an exercise price of $ 8.44 per share, were immediately exercisable
upon issuance, and expire 7 years following the date of issuance.
Number
Weighted
Average
Share Price
Aggregate
Intrinsic Value
Balance as at June 30, 2022
233,100
$ 18.50
-
Granted
1,382,490
$ 8.44
-
Cancelled
( 233,100 )
$ 18.50
-
Balance as at September 30,
2022
1,382,490
$ 8.44
-
12
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
8. SHARE
CAPITAL AND RESERVES (cont’d)
f) Agents’
Investment Options
On
September 13, 2022, 44,931 preferred investment options were issued for services with an exercise price of $ 10.85 per share, were immediately
exercisable upon issuance, and expire approximately 7 years following the date of issuance.
Number
Weighted
Average
Share Price
Aggregate
Intrinsic Value
Balance as at June 30, 2022
15,152
$ 26.81
-
Granted
44,931
$ 10.85
-
Balance
as at September 30, 2022
60,083
$ 14.88
-
9. 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, 2022, there were 20,300 (June 30, 2022 – 18,163 ) options available for future allocation pursuant to SEC
rules and 20 % of the issued and outstanding shares according to the terms of the Plan. 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 (United States 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 United States dollar exercise prices.
13
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
9. SHARE-BASED
PAYMENTS (cont’d)
a) Option
Plan Details (cont’d)
The
following is a summary of changes in outstanding options from July 1, 2022 to September 30, 2022:
Number
Weighted
Average
Exercise Price
$
Balance as at June 30, 2022
55,603
128.59
Granted
560
9.75
Expired/Forfeited
( 2,697 )
46.62
Balance as at September 30,
2022
53,466
124.74
September 30,
2022:
Vested and exercisable
26,531
212.33
Unvested
26,935
38.46
b) Fair
Value of Options Issued During the Period
i) Weighted
Average Fair Value at Grant Date of Options Granted:
The
weighted average fair value at grant date of options granted during the three months ended September 30, 2022, was $ 6.00 per option
(year ended June 30, 2022 - $ 21.04 ). Assumptions used for options granted during the three months ended September 30, 2022 included
a weighted average risk-free interest rate of 3.59 % (year ended June 30, 2022 – 1.17 %), weighted average expected life of 3.3 years
calculated using the Simplified Method for directors, officers and employees, weighted average volatility factor of 91.61 % (year ended
June 30, 2022 – 97.15 %), weighted average dividend yield of 0 % (year ended June 30, 2022 – 0 %) and a 5 % forfeiture rate (year
ended June 30, 2022 – 5 %).
ii) Expenses
Arising from Share-based Payment Transactions:
Total
expenses arising from share-based payment transactions recognized during the three months ended September 30, 2022, were $ 116,681
(2021 - $ 111,142 ). $ 65,072 was allocated to general and administrative expenses (2021 - $ 81,009 ) and the remaining $ 51,609 was allocated
to research and development expenses (2021 - $ 30,133 ). Unrecognized compensation cost at September 30, 2022 related to unvested
options was $ 154,239 which will be recognized over a weighted-average vesting period of 0.8 years.
14
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
10. LEASE
OBLIGATIONS
The
Company is committed to minimum lease payments as follows:
Maturity
Analysis
September 30,
2022
$
Less than one year
338,135
One to five years
200,655
More than five years
-
Total
undiscounted lease liabilities (1)
538,790
(1) Excludes estimated variable operating costs of $ 92,964 and $ 57,274 on an annual basis through to April 30, 2024 and August 31, 2024, respectively.
11. 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,
2022
2021
$
$
Net loss for the period
( 3,510,200 )
( 2,971,615 )
Basic and diluted loss per share
( 4.06 )
( 6.17 )
Weighted average number of common shares - basic and diluted
865,619
481,902
12.
SEGMENT
INFORMATION
The
following table presents information about the Company’s reportable segments for the three months ended September 30, 2022
and 2021:
Three
Months Ended September 30,
2022
2021
InMed
BayMedica
Total
InMed
BayMedica
Total
$
$
$
$
$
$
Sales
-
320,788
320,788
-
-
-
Operating expenses
2,268,831
1,562,157
3,830,988
2,971,615
-
2,971,615
Net loss
( 2,268,831
)
( 1,241,369
)
( 3,510,200
)
( 2,971,615
)
-
( 2,971,615
)
Unrestricted cash
9,227,828
122,599
9,350,427
15,343,905
-
15,343,905
15
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
13. 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, 2022, the following transactions were excluded from the statement of cash flows:
i) On September 13, 2022, the Company issued 44,931 preferred investment options to its placement agent. The fair value of these investment options was $ 451,897 and was included in share issuance costs related to the September 2022 private placement.
ii) As at September 30, 2022, the Company has unpaid financing costs of $ 106,185 .
During
the three months ended September 30, 2021, the following transactions were 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 .
14. COMMITMENTS
AND CONTINGENCIES
Pursuant
to the terms of agreements with various contract research organizations, as at September 30, 2022, the Company is committed for
contract research services and materials at a cost of approximately $ 2,393,075 . A total of $ 1,632,165 of these expenditures are expected
to occur in the twelve months following September 30, 2022 and the balance of $ 760,910 in the following twelve month period.
Pursuant
to the terms of agreements with various vendors, as at September 30, 2022, the Company is committed for contract materials and equipment
at a cost of approximately $ 563,612 , expected to occur in the twelve months following September 30, 2022.
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 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 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 $ 42,125 (June 30, 2022 - $ 44,676 ) that are pledged as security
for a corporate credit card.
16
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
14. COMMITMENTS
AND CONTINGENCIES (cont’d)
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.
Pursuant
to a technology licensing agreement, 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 for issuance date.
The
Company entered into a patent license agreement with a third party (the “Licensor”) in an agreement dated February 15, 2021.
The Company is required to make future royalty payments to Licensor based on net sales of licensed products, with minimum payments required
starting in 2021. In December 2021, the Company amended the License Agreement including the deferral of the 2021 minimum payments to
2022. As at September 30, 2022, the Company has paid $ 300,000 for the minimum payments under the agreement.
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.
15. 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.
17
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
15. FINANCIAL
RISK MANAGEMENT (cont’d)
a) Market
Risk (cont’d):
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, 2022, 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$ 1,712,166 which is equivalent to US$ 1,249,196 at the September 30,
2022 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
increase (decrease) of 1 % in the Canadian dollar in relation to the U.S. dollar results in a gain (loss), with a corresponding effect
on cash flows, of $ 12,492 based on the September 30, 2022 net Canadian dollar assets (liabilities) position. During the three months
ended September 30, 2022, the Company recorded foreign exchange loss of $ 94,392 (2021 – $ 83,800 ) related to Canadian dollars.
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,
2022, holdings of cash and cash equivalents of $ 8,061,484 (June 30, 2022 - $ 5,087,615 ) are subject to floating interest rates. The balance
of the Company’s cash holdings of $ 1,288,943 (June 30, 2022 - $ 1,089,251 ) are non-interest bearing.
As
at September 30, 2022, the Company held variable rate guaranteed investment certificates, with one-year terms, of $ 42,125 (June
30, 2022 - $ 44,676 ).
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.
18
INMED
PHARMACEUTICALS INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED September 30, 2022 AND 2021
(Expressed
in U.S. Dollars)
15. FINANCIAL
RISK MANAGEMENT (cont’d)
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
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,
2022, the Company has cash and cash equivalents and short-term investments of $ 9,392,552 (June 30, 2022 - $ 6,221,670 ), current liabilities
of $ 3,282,053 (June 30, 2022 - $ 3,181,316 ) and a working capital surplus of $ 8,260,856 (June 30, 2022 - $ 6,416,460 ).
16. 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 September 30, 2022, NRF rendered legal services in the amount of $ 67,092
(2021 - $ Nil ) 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.
17. SUBSEQUENT
EVENTS
On
October 13, 2022, in accordance with the BayMedica Agreement, $ 500,000 of escrow payments were made to BayMedica’s historical equity
and convertible debt holders.
In
October 2022, 341,226 of the September 2022 pre-funded warrants were exercised for a total of $ 34 , resulting in the issuance of 341,226
common shares.
19
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
ability to pursue the discovery through to commercialization of Product Candidates and Products
that will treat diseases with high unmet medical needs;
● The
continued optimization of cannabinoid manufacturing approaches;
● Our
success in initiating discussions with potential partners for licensing various aspects of
our Product Candidates;
● Our
ability to commercialize and, where required, register Product Candidates and Products in
the United States and other jurisdictions;
● Our
ability to successfully access existing manufacturing capacity via leases with third-parties
or to transfer our manufacturing processes to a contract manufacturing organizations;
● Our
belief that our manufacturing approaches that we are developing are robust and effective
and will result in high yields of cannabinoids and will be a significant improvement upon
existing manufacturing platforms;
● Our
belief that that INM-755 offers specific advantages and will prove to provide the extensive
relief symptomology with the added potential of addressing the underlying disease in EB;
● The
structure and timing of future INM-755 studies including that we will complete patient enrollment
into our Phase II study in EB in 2022;
● The
ability of the IntegraSyn TM 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 TM or other cost effective approaches
so that it will be commercial-scale ready after Phase II clinical trials are completed, after
which time we may no longer need to source 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 based on several strategic factors;
● Our
ability to monetize our IntegraSyn TM manufacturing approach to the broader pharmaceutical
industry;
20
● Our
ability to continue 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;
● 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 oversee clinical trials for INM-755 in EB and building the requisite internal
commercialization infrastructure to self-market the product to EB clinics;
● Our
ability to find a partnership early in the development process for INM-088 in glaucoma;
● 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 TM 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 TM approach by (i) becoming
a supplier of APIs to the pharmaceutical industry and/or (ii) providing pharmaceutical-grade
ingredients to the non-pharmaceutical market;
● Our
plans to work closely with regulatory authorities and clinical experts in developing the
clinical program for INM-755;
● Our
ability to successfully prosecute patent applications;
● Our
ability to complete formulation development and scale-up, conduct additional preclinical
studies, and initiate and complete IND/CTA-enabling toxicology studies in calendar year 2023
for INM-088;
● INM-088
being a once-a-day or twice-a-day eye drop medication that will compete with treatment modalities
in the medicines category, and with the potential of INM-088 assisting in reducing the high
rate of non-adherence with current glaucoma therapies;
● Our
belief that with a novel delivery system, the reduction of IOP and/or providing neuroprotection
in glaucoma patients by topical (eye drop) application of cannabinoids will hold significant
promise as a new therapy;
● The
potential for any of our patent applications to provide intellectual property protection
for us;
● Our
ability to secure insurance coverage for shipping and storage of Product Candidates, and
clinical trial insurance;
● Our
ability to expand our insurance coverage to include the commercial sale of Products and Product
Candidates;
21
● 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 execute our business strategy;
● Critical
accounting estimates;
● Management’s
assessment of future plans and operations;
● The
outlook of our business and the global economic and geopolitical conditions; and
● The
competitive environment in which we and our business units operate.
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.
22
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, 2022
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Three
Months Ended September 30, 2022
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 23, 2022. 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, 2022, 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,”
“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 prescription-based products, including rare cannabinoids and novel
cannabinoid analogs, targeting the treatment of diseases with high unmet medical needs (“Product Candidates”). Together with
our subsidiary BayMedica, LLC, we also have significant know-how in developing proprietary manufacturing approaches to produce cannabinoids
for various market sectors (“Products”). Our know-how includes traditional approaches such as chemical synthesis and biosynthesis,
as well as a proprietary, integrated manufacturing approach called IntegraSyn TM . We are dedicated to delivering new therapeutic
alternatives to patients and consumers who may benefit from cannabinoid-based products. 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 scientific approaches to establish non-plant-derived (synthetically manufactured), individual cannabinoid
compounds as Product Candidates in important market segments including clinically proven, FDA-approved medicines and Products that are
provided to wholesalers and end-product manufacturers. 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 ingredients 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 or Product Candidates; our current pharmaceutical drug Product
Candidates 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 or Product Candidates. The active pharmaceutical
ingredient (“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 novel cannabinoid analogs to treat diseases including but not limited to neurodegenerative diseases such as Alzheimer’s,
Parkinson’s, and Huntington’s.
23
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
We
believe we are positioned to develop multiple pharmaceutical Product Candidates in diseases which may benefit from medicines based on
rare cannabinoid compounds. Most currently approved cannabinoid therapies are based specifically on CBD and/or 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 pharmaceutical drug candidates through various topical formulations (cream for dermatology, 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, including any drug-drug interactions and any metabolism of the active pharmaceutical
ingredient by the liver. The cannabinoid Products sold through our B2B raw material supply business are integrated into various product
formats by the companies who then further commercializes such products. We plan to access rare cannabinoids via all non-extraction approaches,
including chemical synthesis, biosynthesis and our proprietary integrated 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. On October 13, 2021, we acquired BayMedica, Inc., now named BayMedica, LLC (“BayMedica”). Upon closing
of the transaction, BayMedica became a wholly-owned subsidiary of InMed. 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 the success of our manufacturing technologies. Our net loss was $3.5 million and $3.0 million for the three months
ended September 30, 2022 and 2021, respectively. As of September 30, 2022, we had an accumulated deficit of $97.0 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, 2022 by approximately
$68.1 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 INM-755 program, our lead drug candidate for the treatment of EB;
● 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;
24
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
●
pursue
the discovery of drug targets based on proprietary cannabinoid analogs 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;
●
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;
●
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, 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 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 continuing basis, then we may be unable to continue our operations
at planned levels and be forced to reduce or terminate our operations.
25
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
Recent
Developments
On
September 13, 2022, we closed a $6.0 million private placement. Under the terms of the private placement, an aggregate of 691,245 common
shares, or common share equivalents, and investment options to purchase up to an aggregate of 1,382,490 common shares, at an effective
purchase price of $8.68 per common share and associated investment options. The warrants have an exercise price of $8.44 per share, are
exercisable immediately and have a term of seven years. After deducting the placement agent fees, we received net cash proceeds of approximately
$5.4 million.
Components
of Results of Operations
Revenue
Our
revenue consists of manufacturing and distribution sales of bulk rare cannabinoid Products, which are generally recognized at a point
in time. The Company recognizes revenue when control over the products have been transferred to the customer and the Company has a present
right to payment.
Cost
of Sales
Cost
of sales consist 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.
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 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.
26
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
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.
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 necessary 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 development,
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,
to further advance the development of our manufacturing technologies, and to develop and commercialize additional Products, if any;
●
our ability
to maintain 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;
●
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
● 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 would significantly
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. 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 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.
27
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
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. 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 and trade secrets, product formulation knowledge, 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.
Impairment
of Long-Lived Assets
We
assess the recoverability of our long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset
to future undiscounted net cash flows expected to be generated by the asset or assets. If carrying value exceeds the sum of undiscounted
cash flows, we then determine the fair value of the underlying asset. Any impairment to be recognized is measured as the amount by which
the carrying amount of the asset group exceeds the estimated fair value of the asset group. Assets classified as held for sale are reported
at the lower of the carrying amount or fair value, less costs to sell.
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
As
of the closing of the BayMedica acquisition, the Company aligned into two operating and reportable segments, InMed Pharmaceuticals (the
“InMed” segment) and BayMedica (the “BayMedica” segment).
Comparison
of the three months ended September 30, 2022 and 2021 for InMed Segment
Three
Months Ended
September 30,
2022
2021
Change
%
Change
(in thousands)
Operating expenses:
Research
and development and patents
1,080
1,491
(411 )
-28 %
General and administrative
1,093
1,373
(280 )
-22 %
Amortization and depreciation
26
29
(3 )
-10 %
Total operating expenses
2,199
2,893
(694 )
-24 %
Interest and other income
28
5
23
460 %
Foreign exchange loss
(97 )
(85 )
(12 )
14 %
Net loss
$ (2,268 )
$ (2,973 )
$ 705
-24 %
28
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
Research
and Development and Patents Expenses
Research
and development and patents expenses decreased by $0.4 million in our InMed segment, or 28%, for the three months ended September 30,
2022 compared to the three months ended September 30, 2021. The decrease in research and development and patents expenses was primarily
due to decreased activities related to the INM-755 Phase 2 clinical trials.
General
and administrative expenses
General
and administrative expenses decreased by $0.3 million in our InMed segment, or 20%, for the three months ended September 30, 2022
compared to the three months ended September 30, 2021. The decrease results primarily from a combination of changes including lower personnel
expenses, legal fees, investor relation expenses and accounting fees, partially offset by higher consulting fees.
Foreign
exchange loss
Foreign
exchange loss increased by less than $0.1 million in our InMed segment, or 14%, for the three months ended September 30, 2022, compared
to the three months ended September 30, 2021, as a consequence of holding non-US denominated assets and liabilities combined with
fluctuations in foreign exchange rates.
Comparison
of the three months ended September 30, 2022 and 2021 for BayMedica Segment
Three
Months Ended
September 30,
2022
2021
Change
%
Change
(in thousands)
Sales
$ 321
$ -
$ 321
nm
Cost of sales
235
-
235
nm
Inventory write-down
577
-
577
nm
Gross loss
(491 )
-
(491 )
nm
Operating expenses:
Research and development
and patents
299
-
299
nm
General and administrative
467
-
467
nm
Amortization and depreciation
23
-
23
nm
Total operating expenses
789
-
789
nm
Interest and other income
45
-
45
nm
Tax expense
(7 )
-
(7 )
nm
Net loss
$ (1,242 )
$ -
$ (1,242 )
nm
Sales
We
realized sales of $0.3 million in our BayMedica segment for the three months ended September 30, 2022, the result of manufacturing
and distribution sales of bulk rare cannabinoid Products following the acquisition of BayMedica in October 2021. As the three months
ended September 30, 2021 pre-dated the acquisition of BayMedica, there are no comparable revenues in the 2021 period. As
management has made the decision to refocus on our core business in the pharmaceutical drug development area and reduce our efforts in
BayMedica’s commercial business, we expect to sell inventory on-hand as of September 30, 2022 over the next 15 months. BayMedica
will continue to evaluate opportunities for potential structured supply arrangements and collaborations and will consider other potential
strategic alternatives for the commercial business.
29
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
Cost
of Sales
We
realized cost of goods sold of $0.2 million in our BayMedica segment for the three months ended September 30, 2022, with no comparable
expenses in 2021.
Inventory
Write-Down
The
write-down of inventories to net realizable value was $0.6 million in our BayMedica segment for the three months ended September 30,
2022, with no comparable expenses in 2021. Contributing factors to the decrease in net realizable value included lower demand and downward
pricing pressure.
Gross
Loss
We
realized gross loss of $0.5 million in our BayMedica segment for the three months ended September 30, 2022, with no comparable loss
in 2021.
Research
and Development and Patents Expenses
Research
and development and patents expenses were $0.3 million in our BayMedica segment for the three months ended September 30, 2022. The
increase in research and development and patents expenses was due to the inclusion of BayMedica operating results following the acquisition
date. There were no comparable expenses in 2021.
General
and administrative expenses
General
and administrative expenses were $0.5 million in our BayMedica segment for the three months ended September 30, 2022. The increase
is due to the inclusion of BayMedica operating results following the acquisition date. There were no comparable expenses in 2021.
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 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, 2022, we had cash and cash equivalents of $9.4 million.
The
following table summarizes our cash flows for each of the periods presented:
(in
thousands)
Three
Months
Ended
September 30,
2022
Three
Months
Ended
September 30,
2021
Net cash used in operating activities
$ (2,256 )
$ (2,654 )
Net cash used in investing activities
-
(250 )
Net cash provided by financing activities
5,430
10,885
Net increase in cash
and cash equivalents
$ 3,174
$ 7,981
30
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
Operating
Activities
During
the three months ended September 30, 2022, we used cash in operating activities of $2.3 million, primarily resulting from our net
loss of $3.5 million combined with $0.5 million used in changes in our non-cash working capital, partially offset by non-cash share-based
compensation expenses and inventory write-down.
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 by non-cash share-based
compensation expenses.
Investing
Activities
During
the three months ended September 30, 2022, there were no investing activities.
During
the three months ended September 30, 2021, we used cash in investing activities of $0.3 million, resulting from a pre-acquisition
short-term loan to BayMedica.
Financing
Activities
During
the three months ended September 30, 2022, cash provided by financing activities of $5.4 million consisted of $6.0 million of gross
proceeds from a private placement of our common shares, offset by total transaction costs of $0.6 million.
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.
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 any required investment into BayMedica’s R&D
efforts targeting cannabinoid analogs. 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.
Through
September 30, 2022, we have funded our operations primarily with proceeds from the sale of common stock. We have incurred recurring
losses and negative cash flows from operations since its inception, including net losses of $3.5 million and $3.0 million for the three
months ended September 30, 2022 and 2021, respectively. In addition, we have an accumulated deficit of $97.0 million as of September 30,
2022. 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, 2022 by approximately $68.1 million and we expect to continue
to generate operating losses for the foreseeable future.
As
of the issuance date of the condensed consolidated interim financial statements, we expect our cash and cash equivalents of $9.4 million
as of September 30, 2022 will be sufficient to fund our operating expenses and capital expenditure requirements into the second
half of fiscal 2023, and possibly into the first quarter of fiscal 2024 (being the third calendar quarter of 2023), depending on the
level and timing of realizing revenues from the sale of BayMedica inventory as well as the level and timing of the Company 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.
31
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
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. 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 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 for INM-755;
●
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; and
●
the costs to obtain, maintain,
expand and protect our intellectual property portfolio.
32
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
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 change the costs and timing associated with their development. 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 revenues from either our Products or Product Candidates, 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,
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, we may be required to 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 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.
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, 2022. There have been no significant changes to these policies during the three months ended September 30,
2022.
33
InMed
Pharmaceuticals Inc.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Three
months ended September 30, 2022
Going
Concern
Through
September 30, 2022, 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 $3.5 million and $3.0 million for the three
months ended September 30, 2022 and 2021, respectively. In addition, we have an accumulated deficit of $97.0 million as of September 30,
2022. 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 June 30, 2022 by approximately $68.1 million and we expect to continue to generate
operating losses for the foreseeable future.
As
of the issuance date of the condensed consolidated interim financial statements, we expect our cash and cash equivalents of $9.4 million
as of September 30, 2022 will be sufficient to fund our operating expenses and capital expenditure requirements into the second
half of fiscal 2023, and possibly into the first quarter of fiscal 2024 (being the third calendar quarter of 2023), depending on the
level and timing of realizing revenues from the sale of BayMedica inventory as well as the level and timing of the Company operating
expense. 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 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.
34
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, 2022, 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, 2022,
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 of inadequate resources required to respond to financial reporting
matters other than in the normal course of business, as disclosed in our Annual Report on Form 10-K for the fiscal year ended June 30,
2022.
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, 2022, 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, 2022. Remediation measures include 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 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 2023. 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.
35
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 23, 2022.
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.
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 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).
36
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 14, 2022
By:
/s/
Brenda Edwards
Interim Chief Financial
Officer
37
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.