VANCOUVER, BC, Feb. 11, 2021 /PRNewswire/ - InMed
Pharmaceuticals Inc. ("InMed" or the "Company") (NASDAQ:
INM) (TSX: IN), a clinical-stage pharmaceutical company
developing medications targeting diseases with high unmet medical
need and leading the way in the clinical development of cannabinol
("CBN"), today reported financial results for the second quarter of
fiscal year 2021 ("2Q21") which ended December 31, 2020.
Conference Call & Webcast1:
Thursday, February
11, 2021 at 8:30 AM Pacific Time, 11:30 AM Eastern Time
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The Company's 10-Q including financial statements and related
MD&A for the second quarter ending December 31, 2020 are available at
www.inmedpharma.com, www.sedar.com and at
www.sec.gov.
"The second quarter of fiscal 2021 saw InMed achieve several
key, value-adding and risk mitigating milestones across both its
therapeutic programs and IntegraSynTM manufacturing
approach," said InMed President and Chief Executive Officer,
Eric A. Adams. "We now have a strong
body of safety and tolerability data for INM-755, which is the
basis for our plans to commence safety and efficacy trials in
Epidermolysis Bullosa patients this calendar year. We announced
business development activities in both our ocular therapeutic and
our innovative, biosynthesis-based IntegraSynTM
manufacturing program this last quarter. These announcements are a
reflection of our increased emphasis on business development
activities as an avenue to advance our R&D efforts."
Research & Development Update:
INM-755 for the Treatment of Epidermolysis Bullosa
("EB"):
- On November 25, 2020, InMed
announced top-line results from its 755-101-HV Phase 1 clinical
trial ("Study 101"). Study 101 was a randomized,
vehicle-controlled, double-blind, Phase 1 trial, that examined the
safety and tolerability of two strengths of INM-755 cream on intact
skin in 22 healthy adult volunteers over a 14-day treatment period.
The Study 101 results indicate that INM-755 was safe and
well-tolerated on intact skin, caused no systemic or serious
adverse effects. In addition, there were no subject withdrawals due
to adverse events. Drug concentrations in the blood were very low,
as expected.
- In addition, on January 8, 2021,
we announced top-line results from our second Phase 1 clinical
trial, 755-102-HV ("Study 102"). Study 102 was a randomized,
double-blind, vehicle controlled, single-center study, in 8 healthy
adult volunteers to test the tolerability of 14 days of application
of the INM-755 cream on epidermal wounds under treatment procedures
designed to simulate wound care for Epidermolysis Bullosa ("EB")
patients with open wounds. Results of Study 102 indicate that
INM-755 cream was safe and well-tolerated on induced open epidermal
wounds, caused no systemic or serious adverse effects. In addition,
there were no subject withdrawals due to adverse events.
- These data from Study 101 and Study 102 support moving forward
into clinical trials in patients with EB. Regulatory applications
for a Phase 2 safety and efficacy study in patients with EB are in
preparation with filings in several countries expected in the first
half of calendar 2021, and with patient enrollment anticipated to
begin in the second half of the calendar year.
INM-088 for the Treatment of Glaucoma:
- On December 3, 2020, we announced
securing an exclusive, worldwide license from EyeCRO LLC for its
Microemulsion Drug Ocular Penetration System ("MiDROPS®") eyedrop
delivery technology targeting effective, topical administration of
all cannabinoids, cannabinoid variants and analogs to the eye.
MiDROPS® is a proprietary platform technology designed to
effectively deliver lipophilic molecules to both the anterior and
posterior segments of the eye by means of a stable and comfortable
eyedrop formulation. InMed has completed a preliminary
investigation demonstrating simplicity and effectiveness of
MiDROPS® to deliver sustained levels of CBN to the eye for the
prospective treatment of ocular diseases, including glaucoma. With
this licensing agreement in place, InMed anticipates initiation of
IND-enabling toxicology studies with INM-088 formulation, MiDROPS®
incorporating CBN, in 2021.
IntegraSynTM:
- On November 18, 2020, InMed
announced a broad, reciprocal research collaboration with BayMedica
Inc. to explore synergies between technologies owned by the two
companies. Under the agreement, BayMedica will research the
potential benefits of one or more of the high-efficiency enzyme
gene sequences from InMed's proprietary IntegraSynTM platform for
production of cannabinoids. In exchange, InMed is being granted
access to selected cannabinoid analog compounds from BayMedica's
extensive library to explore their therapeutic potential in
selected disease models in the field of neuroprotection.
Financing Activity and Results of Operations (expressed in
US Dollars):
- On November 16, 2020, the Company
successfully closed a public offering of an aggregate of 1,780,000
common shares, together with accompanying warrants, at a public
offering price of $4.50 per share and
accompanying warrant for total gross proceeds of approximately
$8M. Commensurate with the pricing of
the offering, the Company's shares began trading on the Nasdaq
Capital Market under the trading symbol "INM".
- On February 5, 2021, the Company
announced a private placement with certain institutional investors
to raise aggregate gross proceeds of approximately $4.5 million at a price of $4.25 per unit consisting of one common share and
0.66 of a warrant to purchase one common share. The offering, which
is subject to TSX and Nasdaq approval, is anticipated to close on
or about February 12, 2021. InMed
intends to use the proceeds from the offering, together with its
existing cash resources, for general corporate purposes, funding
preclinical and clinical development programs, advancing
IntegraSynTM, and for working capital purposes.
- For the three and six months ended December 31, 2020, the Company recorded a net
loss of $2.2 million and $3.8 million, or $0.37 and $0.68 per
share, compared with a net loss of $2.5
million and $5.3 million, or
$0.48 and $1.01 per share, for the three and six months
ended December 31, 2019.
- Research and development expenses were $0.9 million for 2Q21, compared with $1.6 million for the three months ended
December 31, 2019. For the six months
ended December 31, 2020, research and
development expenses totaled $1.8
million, which compares with $3.6
million for the comparable period in fiscal 2020. The
reduction in research and development expenses in both the three
months and six months ended December 31,
2020 was primarily due to decreased spending on the
integrated cannabinoid manufacturing program and the INM-755
program, which completed its Phase 1 studies at the end of the
period. In addition, share-based payments were lower and purchases
of the active pharmaceutical ingredient used in INM-755 clinical
trials decreased.
- The Company incurred general and administrative expenses of
$1.0 million for 2Q21, compared with
$0.9 million for the three months
ended December 31, 2019. For the six
months ended December 31, 2020,
general and administrative expenses totaled $1.6 million, which compares with $1.8 million for the comparable period in fiscal
2020. The decrease in general and administrative expenses for the
six months ended December 31, 2020
results from a combination of changes including lower share-based
payments and lower legal costs associated with negotiating research
and development contracts and other matters in the current period
and certain current year legal costs being expensed as finance
expense or capitalized to equity, offset by substantially higher
insurance fees. In addition, a decrease in personnel resulted in
lower salaries and benefits.
- The Company also incurred non-cash, share-based payments, in
connection with the grant of stock options, of $0.1 million for 2Q21, compared with $0.3 million for the three months ended
December 31, 2019. For the six months
ended December 31, 2020, non-cash,
share-based payments totaled $0.1
million, which compares with $0.6
million for the comparable period in fiscal 2020.
Share-based payments amounts are included within research and
development expenses and general and administrative expenses.
- At December 31, 2020, the
Company's cash, cash equivalents and short-term investments were
$10.1 million, which compares to
$4.5 million at September 30, 2020 and $5.8 million at June 30,
2020. The increase in cash, cash equivalents and short-term
investments during the six months to December 31, 2020, was primarily the result of
the November 16, 2020 public offering
partially offset by cash outflows from operating activities.
- At December 31, 2020, the
Company's total issued and outstanding shares were 7,000,707.
Including outstanding stock options and warrants, as at
December 31, 2020, the Company had
9,676,774 shares on a fully diluted basis. During the three and six
months ending December 31, 2020, the
weighted average number of common shares was 6,091,359 and
5,656,033, which is used for the calculation of loss per share for
the respective interim periods.
Table 1: Condensed consolidated interim balance
sheets (unaudited):
InMed
Pharmaceuticals Inc
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CONDENSED
CONSOLIDATED INTERIM BALANCE SHEETS (unaudited)
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As at December 31,
2020 and June 30, 2020
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|
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Expressed in U.S.
Dollars
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|
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December
31,
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June
30,
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2020
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2020
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ASSETS
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$
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$
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Current
|
|
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Cash and cash
equivalents
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10,020,853
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5,805,809
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Short-term
investments
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45,225
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42,384
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Accounts
receivable
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154,846
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45,344
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Prepaids and other
assets
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28,464
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418,920
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Total current
assets
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10,249,388
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6,312,457
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Non-Current
|
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Property and
equipment, net
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373,844
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403,485
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Intangible assets,
net
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1,109,535
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1,086,655
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Other
assets
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14,655
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-
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Total
Assets
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11,747,422
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7,802,597
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LIABILITIES AND
SHAREHOLDERS' EQUITY
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|
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Current
|
|
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Accounts payables and
accrued liabilities
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2,077,325
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1,607,303
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Current portion of
lease obligations
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76,312
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68,965
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Total current
liabilities
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2,153,637
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1,676,268
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Non-current
|
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Lease
obligations
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238,992
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248,011
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Derivative warrants
liability
|
1,763,980
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-
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Total
Liabilities
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4,156,609
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1,924,279
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Shareholders'
Equity
|
|
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Common shares, no par
value, unlimited authorized shares:
|
|
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7,000,707 (June 30,
2020 - 5,220,707) issued and outstanding
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58,008,112
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53,065,240
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Additional paid-in
capital
|
17,946,374
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17,764,333
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Accumulated
deficit
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(68,492,242)
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(64,649,381)
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Accumulated other
comprehensive income (loss)
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128,569
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(301,874)
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Total
Shareholders' Equity
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7,590,813
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5,878,318
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Total Liabilities
and Shareholders' Equity
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11,747,422
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7,802,597
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Table 2: Condensed consolidated interim statements
of operations and comprehensive loss
(unaudited):
InMed
Pharmaceuticals Inc
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|
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CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (unaudited)
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|
For the three and six
months ended December 31, 2020 and 2019
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|
|
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Expressed in U.S.
Dollars
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|
|
|
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Three Months
Ended
|
Six Months
Ended
|
|
December
31
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December
31
|
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2020
|
2019
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2020
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2019
|
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$
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$
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$
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$
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Operating
Expenses
|
|
|
|
|
Research and
development and patents
|
937,948
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1,606,831
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1,849,104
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3,568,743
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General and
administrative
|
959,554
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871,745
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1,584,342
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1,759,256
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Amortization and
depreciation
|
36,816
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28,232
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64,797
|
58,459
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Total operating
expenses
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1,934,318
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2,506,808
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3,498,243
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5,386,458
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|
|
|
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Other Income
(Loss)
|
|
|
|
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Interest income
|
3,050
|
40,495
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7,395
|
98,901
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Finance expense
|
(360,350)
|
-
|
(360,350)
|
-
|
Unrealized gain on derivative warrants liability
|
242,628
|
-
|
242,628
|
-
|
Foreign exchange loss
|
(194,792)
|
(27,182)
|
(234,291)
|
(11,250)
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Net loss for the
period
|
(2,243,782)
|
(2,493,495)
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(3,842,861)
|
(5,298,807)
|
|
|
|
|
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Other
Comprehensive Loss
|
|
|
|
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Foreign currency
translation gain
|
301,043
|
350,154
|
430,443
|
31,676
|
Total
comprehensive loss for the period
|
(1,942,739)
|
(2,143,341)
|
(3,412,418)
|
(5,267,131)
|
|
|
|
|
|
Net loss per share
for the year
|
|
|
|
|
Basic and
diluted
|
(0.37)
|
(0.48)
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(0.68)
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(1.01)
|
Weighted average
outstanding common shares
|
|
|
|
|
Basic and
diluted
|
6,091,359
|
5,220,707
|
5,656,033
|
5,220,707
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Table 3: Condensed consolidated interim statements
of cash flows (unaudited):
InMed
Pharmaceuticals Inc.
|
|
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CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(unaudited)
|
|
For the six months
ended December 31, 2020 and 2019
|
|
|
Expressed in U.S.
Dollars
|
|
|
|
2020
|
2019
|
|
|
|
Cash provided by
(used in):
|
$
|
$
|
|
|
|
Operating
Activities
|
|
|
Net loss for the
period
|
(3,842,861)
|
(5,298,807)
|
Items not requiring
cash:
|
|
|
Amortization and
depreciation
|
64,797
|
58,459
|
Share-based
compensation
|
182,041
|
634,435
|
Non-cash lease
expense
|
61,065
|
35,506
|
Loss on disposal of
assets
|
-
|
810
|
Received interest
income on short-term investments
|
137
|
80,988
|
Unrealized gain on
derivative warrants liability
|
(242,628)
|
-
|
Payments on lease
obligations
|
(41,057)
|
(24,586)
|
Finance
expense
|
360,350
|
-
|
Changes in non-cash
working capital:
|
|
|
Prepaids and other
assets
|
105,126
|
57,921
|
Other non-current
assets
|
(14,161)
|
-
|
Accounts
receivable
|
(102,729)
|
-
|
Accounts payable and
accrued liabilities
|
296,971
|
269
|
Total cash used in
operating activities
|
(3,172,949)
|
(4,455,005)
|
|
|
|
Investing
Activities
|
|
|
Maturity of short-term
investments
|
-
|
3,859,096
|
Purchase of short-term
investments
|
-
|
(26,445)
|
Proceeds on disposal
of property and equipment
|
-
|
550
|
Purchase of property
and equipment
|
-
|
(34,701)
|
Total cash
provided by investing activities
|
-
|
3,798,500
|
|
|
|
Financing
Activities
|
|
|
Shares issued for
cash
|
8,010,000
|
-
|
Share issuance
costs
|
(1,116,967)
|
-
|
Total cash
provided by financing activities
|
6,893,033
|
-
|
Effects of foreign
exchange on cash and cash equivalents
|
494,960
|
18,037
|
Increase
(decrease) in cash during the period
|
4,215,044
|
(638,468)
|
Cash and cash
equivalents beginning of the period
|
5,805,809
|
9,837,213
|
Cash and cash
equivalents end of the period
|
10,020,853
|
9,198,745
|
About InMed: InMed Pharmaceuticals is a clinical-stage
pharmaceutical company developing a pipeline of cannabinoid-based
medications, initially focused on the therapeutic benefits of
cannabinol (CBN) in diseases with high unmet medical need. The
Company is dedicated to delivering new therapeutic alternatives to
patients that may benefit from cannabinoid-based medicines. For
more information, visit www.inmedpharma.com.
Cautionary Note Regarding Forward-Looking
Information:
This news release contains "forward-looking information" and
"forward-looking statements" (collectively, "forward-looking
information") within the meaning of applicable securities
laws. Forward-looking information is based on management's
current expectations and beliefs and is subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Forward-looking information in this news release includes
statements about: leading the way in the clinical development of
cannabinol ("CBN"); developing a pipeline of cannabinoid-based
medications in diseases with high unmet medical need; delivering
new therapeutic alternatives to patients that may benefit from
cannabinoid-based medicines; commencing safety and efficacy trials
in Epidermolysis Bullosa patients in calendar 2021; increasing
business development activities to advance our research and
development efforts; filing of regulatory applications for a Phase
2 safety and efficacy study in patients with EB in several
countries in the first half of calendar 2021, and commencing
patient enrollment the second half of the calendar year; being able
to deliver sustained levels of CBN to the eye for the prospective
treatment of ocular diseases; initiating IND-enabling toxicology
studies with INM-088 formulation, MiDROPS® incorporating CBN, in
2021; exploring the therapeutic potential of BayMedica Inc.'s
cannabinoid analog compounds in selected disease models in the
field of neuroprotection; and the closing of the private placement,
announced on February 5, 2021, on or
about February 12, 2021 or at
all.
With respect to the forward-looking information contained in
this news release, InMed has made numerous assumptions regarding,
among other things: the closing of the private placement on a
timely basis on the terms described, or at all; continued and
timely positive preclinical and clinical efficacy data; the speed
of regulatory approvals; the ability to contract with suitable
partners; demand for InMed's products; and continued economic and
market stability. While InMed considers these assumptions to
be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social
uncertainties and contingencies.
Additionally, there are known and unknown risk factors which
could cause InMed's actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
information contained herein. Known risk factors include, among
others: regulatory filings may not be filed or approved on a timely
basis, or at all; our securities issuable in connection with the
private placement may not be accepted for registration by the
Securities and Exchange Commission on a timely basis, or at all;
the outbreak and impact of COVID-19 may worsen; preclinical and
clinical testing may not produce the desired results on a timely
basis, or at all; cannabis licensing/importing issues may delay our
projected development timelines; suitable partners may not be
located; economic or market conditions may worsen; our existing
cash runway may not allow us to complete our forthcoming
significant milestones; the development of a proprietary
biosynthesis manufacturing technology for the production of
pharmaceutical-grade cannabinoids as well as a pipeline of
medications targeting diseases with high unmet medical needs may
not be as successful as desired, if at all. A more complete
discussion of the risks and uncertainties facing InMed is disclosed
in InMed's filings with the Security and Exchange Commission and
the most recent Annual Information Form and other continuous
disclosure filed with Canadian securities regulatory authorities on
SEDAR at www.sedar.com.
All forward-looking information herein is qualified in its
entirety by this cautionary statement, and InMed disclaims any
obligation to revise or update any such forward-looking information
or to publicly announce the result of any revisions to any of the
forward-looking information contained herein to reflect future
results, events or developments, except as required by law.
NEITHER THE TORONTO
STOCK EXCHANGE NOR ITS REGULATIONS
SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE
ADEQUACY OR ACCURACY OF THIS RELEASE.
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SOURCE InMed Pharmaceuticals Inc.