VANCOUVER, May 14, 2020 /CNW/ - InMed
Pharmaceuticals Inc. ("InMed" or the "Company") (TSX: IN;
OTCQX: IMLFF), 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 third quarter of fiscal
year 2020 ("3Q20") which ended March 31,
2020.
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2020 at 8:30 AM Pacific Time, 11:30 AM Eastern
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"In the third quarter of fiscal 2020, InMed made important
strides in both its therapeutic development and cannabinoid
biosynthesis programs," stated InMed President and Chief Executive
Officer, Eric A. Adams. "We continue
to lead the clinical development of cannabinol as a potential
therapeutic option for skin and ocular diseases as demonstrated by
completion of our first Phase 1 trial with INM-755 and ongoing
preclinical and formulation work with INM-088. We are now well
underway toward the initiation of our second Phase 1 trial for
INM-755 with acceptance of the Clinical Trial Application ("CTA")
last month. In addition, as announced earlier this week, we are
continuing to strengthen our patent position for therapeutic
cannabinoid applications including the potential treatment of
glaucoma. Meanwhile, we are pleased with the progress our
scientific team has been making, working behind the scenes with
world-class organizations such as the Almac Group (UK) ("Almac"),
towards innovative cannabinoid manufacturing methods."
Research & Development Update:
- INM-755 for the treatment of epidermolysis bullosa
("EB"). On April 1, 2020,
InMed announced completion of treatment and clinical evaluation in
the 755-101-HV Phase 1 trial with INM-755, a CBN skin cream. One
week prior to that date, with no interim adverse events having been
observed in the 755-101-HV trial in healthy volunteers on intact
skin that would preclude further development, InMed filed a CTA for
its second Phase 1 trial in healthy volunteers (755-102-HV). This
second trial will examine the safety of INM-755 on epidermal
wounds. On April 30, 2020, InMed
announced approval of this second CTA. InMed is actively working
with its clinical trial partners at the Centre for Human Drug
Research in the Netherlands to
prepare for subject enrollment in Study 755-102-HV as expediently
as reasonable. Final results from the 755-101-HV trial are
anticipated to be announced in the third quarter of calendar
2020.
- INM-088 for the treatment of glaucoma.
InMed has completed in vitro and in vivo testing and
is near completion of formulation study data analysis for INM-088.
InMed has continued to firm up its intellectual property position
via the filing of a Patent Cooperation Treaty, or PCT, application
for the neuroprotective effect of CBN. Next steps in the INM-088
program include selection of a final delivery technology and
conducting additional in vivo studies, if needed. Depending
on the results of those studies, InMed continues to anticipate
commencement of IND-enabling preclinical toxicology studies in the
second half of calendar 2020.
- Biosynthesis manufacturing technology. InMed
recently announced that it is working with Almac in developing
innovative methods for low-cost, high yield and
pharmaceutical-grade cannabinoid manufacturing. Specifically, InMed
is combining its scientific expertise with Almac's recognized
leadership in enzyme engineering, process-development and good
manufacturing practice ("GMP") manufacturing capability to enable
InMed's biosynthesis program. Based on the current plan, InMed
anticipates this process to be GMP-batch ready in 4Q of calendar
2020.
Results of Operations (expressed in Canadian
Dollars):
- For the three and nine months ended March 31, 2020, the Company recorded a net loss
of $2.81 million and $9.54 million, or $0.02 and $0.06 per
share, compared with a net loss of $3.49
million and $8.99 million, or
$0.02 and $0.05 per share, for the three and nine months
ended March 31, 2019.
- Research and development expenses were $1.59 million for 3Q20, compared with
$1.62 million for the three months
ended March 31, 2019. For the nine
months ended March 31, 2020, research
and development expenses totaled $5.85
million, which compares with $3.19
million for the comparable period in fiscal 2019. While
research and development expenses for the three months ended
March 31, 2020 and the three months
ended March 31, 2019 were fairly
equivalent, the increase in research and development expenditures
between the nine months ended March 31,
2020 as compared to the equivalent period in fiscal 2019,
did see a large increase. This increase of $2.66 million between these nine-month periods
was primarily due to increased spending on INM-755 preclinical
safety pharmacology and toxicology studies, manufacturing costs for
INM-755 material to be used in the Phase 1 clinical trials and the
commencement of the first Phase 1 trial. In addition, the Company
incurred increased salaries and benefits commensurate with the
increase in research and development activities.
- The Company incurred general and administrative expenses of
$1.04 million for 3Q20, compared with
$0.99 million for the three months
ended March 31, 2019. For the nine
months ended March 31, 2020, general
and administrative expenses totaled $2.93
million, which compares with $2.72
million for the comparable period in fiscal 2019. The
increase in general and administrative expenses for both the three
and nine months to March 31, 2020 was
primarily due to increased accounting and legal expenses pertaining
to certain corporate initiatives and increased salaries and
benefits offset by decreased investor relation related
expenditures.
- The Company also incurred non-cash, share-based payments, in
connection with the grant of stock options, of $0.37 million for 3Q20, compared with
$0.89 million for the three months
ended March 31, 2019. For the nine
months ended March 31, 2020,
non-cash, share-based payments totaled $0.96
million, which compares with $3.34
million for the comparable period in fiscal 2019.
- At March 31, 2020, the Company's
cash, cash equivalents and short-term investments were $9.94 million, which compares to $18.04 million at June 30,
2109 and $12.01 million at
December 30, 2019. The decrease in
cash, cash equivalents and short-term investments during the nine
months to December 31, 2019, was
primarily due to cash outflows from operating activities.
- At March 31, 2020, the Company's
total issued and outstanding shares were 172,283,633. In addition,
at March 31, 2020, there were
17,717,641 warrants, expiring June
2020, with a weighted average price of $1.24 and 19,462,500 outstanding stock options
with a weighted average exercise price of $0.45.
Table 1: Condensed consolidated statements of
financial position
(unaudited):
InMed
Pharmaceuticals Inc.
|
|
|
|
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(unaudited)
|
|
As at March 31, 2020
and June 30, 2019
|
|
|
|
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
March
31,
|
|
June
30,
|
|
|
2020
|
|
2019
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
|
|
|
|
|
Cash and cash
equivalents
|
$
|
9,886,395
|
$
|
12,873,961
|
Short-term
investments
|
|
57,725
|
|
5,165,093
|
Accounts
receivable
|
|
45,525
|
|
84,987
|
Prepaids and
advances
|
|
263,139
|
|
424,275
|
Total current
assets
|
|
10,252,784
|
|
18,548,316
|
|
|
|
|
|
Non-Current
|
|
|
|
|
Property and
equipment
|
|
587,369
|
|
55,829
|
Intangible
assets
|
|
1,114,302
|
|
1,184,720
|
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
$
|
11,954,455
|
$
|
19,788,865
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
Current
|
|
|
|
|
Accounts payables and
accrued liabilities
|
$
|
1,859,611
|
$
|
1,562,865
|
Current portion of
lease obligations
|
|
92,131
|
|
-
|
Total current
liabilities
|
|
1,951,742
|
|
1,562,865
|
|
|
|
|
|
Non-current
|
|
|
|
|
Lease
obligations
|
|
364,307
|
|
-
|
|
|
2,316,049
|
|
1,562,865
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
Share
capital
|
|
68,579,890
|
|
68,579,890
|
Contributed
surplus
|
|
15,172,890
|
|
14,216,224
|
Accumulated
deficit
|
|
(74,114,374)
|
|
(64,570,114)
|
|
|
9,638,406
|
|
18,226,000
|
|
$
|
11,954,455
|
$
|
19,788,865
|
Table 2: Condensed consolidated statements of
operations and comprehensive loss
(unaudited):
InMed
Pharmaceuticals Inc.
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (unaudited)
|
|
|
For the three and
nine months ended March 31, 2020 and 2019
|
|
|
|
|
|
|
|
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
March 31
|
|
March 31
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,585,447
|
$
|
1,615,729
|
$
|
5,849,315
|
$
|
3,189,671
|
General and
administrative
|
|
1,040,045
|
|
988,632
|
|
2,934,756
|
|
2,723,265
|
Amortization and
depreciation
|
|
58,797
|
|
31,538
|
|
161,680
|
|
94,267
|
Share-based
payments
|
|
365,141
|
|
890,581
|
|
956,666
|
|
3,337,640
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
3,049,430
|
|
3,526,480
|
|
9,902,417
|
|
9,344,843
|
|
|
|
|
|
|
|
|
|
Other Income
(Loss)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
35,411
|
|
108,887
|
|
165,984
|
|
341,453
|
Foreign exchange gain
(loss)
|
|
207,017
|
|
(72,978)
|
|
192,173
|
|
18,024
|
|
|
|
|
|
|
|
|
|
Total net and
comprehensive loss for the
period
|
$
|
(2,807,002)
|
$
|
(3,490,571)
|
$
|
(9,544,260)
|
$
|
(8,985,366)
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share for the
period
|
$
|
(0.02)
|
$
|
(0.02)
|
$
|
(0.06)
|
$
|
(0.05)
|
Table 3: Condensed consolidated interim statements
of cash flows (unaudited):
InMed
Pharmaceuticals Inc.
|
|
|
|
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
For the nine months
ended March 31, 2020 and 2019
|
|
|
|
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
Cash flows from
operating activities
|
|
|
|
|
Net loss for the
period
|
$
|
(9,544,260)
|
$
|
(8,985,366)
|
Adjustments to
reconcile loss to net cash used in
operating activities
|
|
|
|
|
Amortization and
depreciation
|
|
161,680
|
|
94,267
|
Share-based
payments
|
|
956,666
|
|
3,337,640
|
Loss on sale of
assets
|
|
3,097
|
|
-
|
Interest accretion on
lease obligations
|
|
17,430
|
|
-
|
|
|
|
|
|
Changes in non-cash
working capital balances:
|
|
|
|
|
Prepaids and
advances
|
|
96,221
|
|
(445,702)
|
Interest income
accrued on short-term investments
|
|
107,368
|
|
(68,860)
|
Accounts
receivable
|
|
39,462
|
|
(23,513)
|
Accounts payable and
accrued liabilities
|
|
296,746
|
|
(269,973)
|
|
|
|
|
|
Total cash
provides by (outflows from) operating
activities
|
|
(7,865,590)
|
|
(6,361,507)
|
|
|
|
|
|
Cash Flows From
Investing Activities
|
|
|
|
|
Proceeds (purchase)
of short-term investments
|
|
5,000,000
|
|
(5,028,750)
|
Purchase of property
and equipment
|
|
(57,785)
|
|
(17,784)
|
Proceeds on disposal
of property and equipment
|
|
726
|
|
-
|
Total cash
provided by (outflows from) investing
activities
|
|
4,942,941
|
|
(5,046,534)
|
|
|
|
|
|
Cash Flows From
Financing Activities
|
|
|
|
|
Payments on lease
obligations
|
|
(64,917)
|
|
-
|
Shares issued for
cash
|
|
-
|
|
205,000
|
|
|
|
|
|
Total cash
provided by (used in) financing
activities
|
|
(64,917)
|
|
205,000
|
|
|
|
|
|
Decrease in cash
during the period
|
|
(2,987,566)
|
|
(11,203,041)
|
|
|
|
|
|
Cash and cash
equivalents beginning of the period
|
|
12,873,961
|
|
24,134,277
|
|
|
|
|
|
Cash and cash
equivalents end of the period
|
$
|
9,886,395
|
$
|
12,931,236
|
About InMed: InMed Pharmaceuticals is a clinical
stage biopharmaceutical company developing a pipeline of
cannabinoid-based medications, initially focused on the therapeutic
benefits of cannabinol (CBN) in diseases with high unmet medical
needs. 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.
About Cannabinol (CBN): CBN is a rare
cannabinoid with unique physiological properties that may result in
distinct therapeutic and safety characteristics relative to the
more commonly known cannabinoids tetrahydrocannabinol (THC) and
cannabidiol (CBD). InMed Pharmaceuticals is exploring the
therapeutic potential of CBN in diseases with high unmet medical
need.
About INM-755: INM-755 is a CBN cream intended as a
topical therapy to treat epidermolysis bullosa (EB) and potentially
other dermatological diseases. Preclinical data demonstrate that
INM-755 may help relieve hallmark EB symptoms, such as inflammation
and pain, as well potentially restore the integrity of the skin in
a subset of EB Simplex patients.
About Epidermolysis Bullosa (EB): EB is the
collective name of a group of genetic disorders of connective
tissues affecting individuals from birth and is characterized by
fragile skin that is easily damaged, leading to extensive
blistering and wounding. The blisters may appear in response to
minor injury, even from heat, rubbing, scratching or adhesive tape.
The disease has no definitive cure and all currently used
treatments are directed towards symptomatic relief.
About INM-088: InMed is developing INM-088 as a CBN eye
drop formulation targeting reduction of the intraocular pressure
associated with glaucoma as well as being designed to serve as a
neuroprotectant to the retinal ganglion cells.
About Glaucoma: Glaucoma is a group of eye
conditions characterized by abnormally high pressure in the eye,
which can damage the membranes of the retina and the head of the
optic nerve, leading to blindness. Glaucoma is the second leading
cause of blindness worldwide and can occur at any age but is more
common in older adults.
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; and delivering new therapeutic alternatives to patients that
may benefit from cannabinoid-based medicines; leading the clinical
development of cannabinol as a potential therapeutic option for
skin and ocular diseases; initiating the second Phase 1 trial for
INM-755; continuing to strengthen our patent position for
therapeutic cannabinoid applications including the potential
treatment of glaucoma; developing innovative new cannabinoid
manufacturing methods; examining the safety of INM-755 on epidermal
wounds in the 755-102-HV trial; announcing final results from the
755-101-HV trial in the third quarter of calendar 2020; selecting a
final delivery technology and conducting additional in vivo
studies for the INM-088 program; commencing IND-enabling
preclinical toxicology studies in the second half of calendar 2020
for INM-088; developing innovative methods for low-cost, high yield
and pharmaceutical-grade cannabinoid manufacturing; having the
biosynthesis process GMP-batch ready in the fourth quarter of
calendar 2020; CBN having potential therapeutic advantages in
specific disease models over certain cannabinoids; INM-088 reducing
intraocular pressure and acting as a neuroprotectant to the
retinal ganglion cells and optic nerve; INM-755 potentially
relieving EB symptoms, such as inflammation and pain as well as
potentially enhancing skin integrity in a subset of EB Simplex
patients; and developing 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;.
With respect to the forward-looking information contained in
this news release, InMed has made numerous assumptions regarding,
among other things: 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: 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; regulatory applications may
not be approved 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 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.