TSX:IN
OTCQX:IMLFF
VANCOUVER, Nov. 12, 2018 /PRNewswire/ - InMed
Pharmaceuticals Inc. ("InMed" or the "Company") (TSX:IN;
OTCQX:IMLFF), a fully integrated, cannabinoid-based
biopharmaceutical company that leverages its proprietary platform
technologies to develop novel therapeutics for the treatment of
diseases with high unmet medical needs, today reported financial
results for the three months ended September
30, 2018, which is the Company's first quarter of fiscal
year 2019 ("1Q19").
Conference Call
& Webcast:
|
Monday, November 12,
2018 at 10:00 AM Pacific Time, 1:00 PM Eastern Time
|
Toronto:
|
+1-416-764-8688
|
Vancouver:
|
+1-778-383-7413
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North America (Toll
Free):
|
+1-888-390-0546
|
Conference
ID:
|
01602924
|
Webcast:
|
https://event.on24.com/wcc/r/1869369/F1C676960976FEF685DFF9F12469BA4E
|
Replays,
Available through November 19, 2018:
|
Toronto:
|
+1-416-764-8677
|
North America (Toll
Free):
|
+1-888-390-0541
|
Playback
Passcode:
|
602924#
|
The Company's full financial statements and related MD&A for
the three months ended September 30,
2018 will be available at www.sedar.com on November 12, 2018.
"We continued to make solid progress on our operating strategy
during 1Q19, which is, first and foremost, diligent execution with
our leading R&D programs" stated President and Chief Executive
Officer, Eric A. Adams. Mr.
Adams continued, "During the quarter, we made considerable
advancements with our INM-750 program for the treatment of
Epidermolysis Bullosa, and we currently believe that we remain on
track to begin discussions of our clinical development plans with
regulatory authorities in the first half of 2019 and for a CTA/IND
filing for INM-750 in the second half of 2019."
"Specifically, within our INM-750 program," Mr. Adams continued,
"among many other pre-clinical studies, we conducted drug
permeation studies on several formulation variations. In
these studies, with our selected formulation, we demonstrated good
drug penetration and adequate drug concentrations in the epidermis,
which is the target tissue for INM-750. In addition, and very
importantly, we have demonstrated that the cannabinoid components
in the INM-750 formulation each play important, and independent,
functions for various target effects, including anti-inflammation
and keratin upregulation."
"Concerning our ongoing work in toxicology and pharmacology, we
completed two types of genotoxicity studies, which demonstrated no
mutagenicity with the cannabinoid components of INM-750. In
addition, we completed two 7-day dose range finding and
pharmacokinetic studies for assessment of systemic toxicity.
The lack of any negative results from these studies support
continued development of INM-750," added Mr. Adams.
"During 1Q19," Mr. Adams continued, "we also made meaningful
strides to advance our proprietary biosynthesis manufacturing
technology. In particular, we announced entering into a
service agreement with the National Research Council Canada (NRC)
in Montreal, Canada in October,
for bio-fermentation development and scale-up processes for
cannabinoid biosynthesis in E. coli. Since then, we have
initiated our technology transfer from our partners at The
University of British Columbia (UBC) to
the NRC. This collaboration moves us one step closer to
achieving our ambition of being able to produce multiple
pharmaceutical-grade cannabinoids on a commercial scale."
Mr. Adams continued, "In addition, I'd like to reiterate a
material development in strengthening our IP portfolio.
Specifically, we successfully converted our provisional patent to a
PCT patent filing for 'Metabolic Engineering of bacterium E. coli
for cannabinoid products'. We also announced that our
research partner at UBC received a grant from the prestigious
Natural Sciences and Engineering Research Council of Canada (NSERC) for our collaborative efforts
in the biosynthesis of cannabinoids," concluded Mr. Adams.
Results of Operations (expressed in Canadian
Dollars):
- For 1Q19, the Company recorded a comprehensive net loss of
$2.8 million, or $0.02 per share, compared with a comprehensive
net loss of $1.8 million, or
$0.01 per share, for the three months
ended September 30, 2017 ("1Q18").
The primary reason for the increase in the comprehensive net loss
in 1Q19 compared to 1Q18 in fiscal year 2018 was an increase in
non-cash, share-based payments, in connection with the grant of
stock options, which was $1.4 million
for 1Q19, compared with $0.6 million
for 1Q18, with the increase attributable to stock options granted
during the second half of fiscal 2018.
- Research and development expenses were $0.63 million for 1Q19, compared with
$0.38 million for the three months
ended September 30, 2017. The
increase in research and development expenses in 1Q19 as compared
to 1Q18 was primarily due to increased spending with external
contractors for work associated with preclinical studies and
formulation work for INM-750 together with increased spending on
the Company's biosynthesis program, as well as higher R&D
personnel compensation as a result of increased R&D
staffing.
- The Company incurred general and administrative expenses of
$0.81 million for 1Q19, compared with
$0.84 million for the three months
ended September 30, 2017. The
decrease in general and administrative expenses in 1Q19 as compared
to 1Q18 was primarily due to decreased spending on investor
relations activities that more than offset increased personnel
compensation that reflects increased staffing, reflective of the
growth in the Company's operations.
- At September 30, 2018, the
Company's cash, cash equivalents and short-term investments were
$24.8 million, which compares to
$26.5 million at June 30, 2018. During 1Q19, the Company's cash,
cash equivalents and short-term investments decreased by
$1.7 million, which resulted
primarily from cash outflows from operating activities.
- At September 30, 2018, the
Company's total issued and outstanding shares were 170,883,633.
Including outstanding stock options and warrants, as at
September 30, 2018, the Company had
221,291,290 shares on a fully diluted basis. During 1Q19, the
weighted average number of common shares was 170,856,278, which is
used for the calculation of loss per share.
Table 1: Condensed consolidated interim statements
of financial position
(un-audited):
InMed
Pharmaceuticals Inc.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(un-audited)
|
As at September 30,
2018 and June 30, 2018
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
|
September
30
|
|
June 30
|
|
|
|
2018
|
|
2018
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
Current
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
17,392,246
|
$
|
24,134,277
|
Short-term
investments
|
|
|
7,384,854
|
|
2,342,615
|
Taxes
recoverable
|
|
|
20,321
|
|
53,373
|
Prepaids and
advances
|
|
|
210,994
|
|
203,477
|
Total current
assets
|
|
|
25,008,415
|
|
26,733,742
|
|
|
|
|
|
|
Non-Current
|
|
|
|
|
|
Property and
equipment
|
|
|
50,450
|
|
55,732
|
Intangible
assets
|
|
|
1,250,760
|
|
1,273,670
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
$
|
26,309,625
|
$
|
28,063,144
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
Current
|
|
|
|
|
|
Trade
payables
|
|
|
590,424
|
|
937,759
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
Share
capital
|
|
|
68,079,139
|
|
68,058,698
|
Contributed
surplus
|
|
|
11,796,358
|
|
10,381,759
|
Accumulated
deficit
|
|
|
(54,156,296)
|
|
(51,315,072)
|
|
|
|
25,719,201
|
|
27,125,385
|
|
|
$
|
26,309,625
|
$
|
28,063,144
|
Table 2: Condensed consolidated interim statements
of comprehensive loss (un-audited):
InMed
Pharmaceuticals Inc.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(un-audited)
|
For the three months
ended September 30, 2018 and September 30, 2017
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
General and
administrative
|
|
$
|
813,036
|
$
|
841,340
|
Research and
development
|
|
|
627,094
|
|
377,116
|
Amortization and
depreciation
|
|
|
31,041
|
|
26,626
|
Foreign exchange
loss
|
|
|
56,836
|
|
4,524
|
Share-based
payments
|
|
|
1,423,790
|
|
570,548
|
|
|
|
|
|
|
Total
expenses
|
|
|
2,951,797
|
|
1,820,154
|
|
|
|
|
|
|
Interest
income
|
|
|
110,573
|
|
-
|
|
|
|
|
|
|
Loss before other
items
|
|
|
(2,951,797)
|
|
(1,820,154)
|
|
|
|
|
|
|
Total
comprehensive loss for the period
|
|
$
|
(2,841,224)
|
$
|
(1,820,154)
|
|
|
|
|
|
|
Basic and diluted
loss per share for the period
|
|
$
|
(0.02)
|
$
|
(0.01)
|
Table 3: Condensed consolidated interim statements
of cash flows (un-audited):
InMed
Pharmaceuticals Inc.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(un-audited)
|
For the three months
ended September 30, 2018 and September 30, 2017
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
Cash flows from
operating activities
|
|
|
|
|
|
Loss for the
year
|
|
$
|
(2,841,224)
|
$
|
(1,820,154)
|
Adjustments to
reconcile loss to net cash used in operating activities
|
|
|
|
|
|
Amortization
and depreciation
|
|
|
31,041
|
|
26,626
|
Share-based
payments
|
|
|
1,423,790
|
|
570,548
|
Shares issued
for services
|
|
|
-
|
|
-
|
Accrued
interest income on short-term investments
|
|
|
(13,487)
|
|
-
|
|
|
|
|
|
|
Changes in non-cash
working capital balances:
|
|
|
|
|
|
Prepaids and
advances
|
|
|
(7,517)
|
|
40,943
|
Taxes
recoverable
|
|
|
33,052
|
|
35,180
|
Trade
payables
|
|
|
(347,335)
|
|
(202,750)
|
|
|
|
|
|
|
Total cash
outflows from operating activities
|
|
|
(1,721,680)
|
|
(1,349,607)
|
|
|
|
|
|
|
Cash Flows From
Investing Activities
|
|
|
|
|
|
Purchase of
short-term investments
|
|
|
(5,028,752)
|
|
-
|
Purchase of property
and equipment
|
|
|
(2,849)
|
|
(4,427)
|
|
|
|
|
|
|
Total cash
outflows from investing activities
|
|
|
(5,031,601)
|
|
(4,427)
|
Cash Flows From
Financing Activities
|
|
|
|
|
|
Subscriptions
received
|
|
|
-
|
|
-
|
Shares issued for
cash
|
|
|
11,250
|
|
679,000
|
Share issue
costs
|
|
|
-
|
|
-
|
|
|
|
|
|
|
Cash provided by
financing activities
|
|
|
11,250
|
|
679,000
|
|
|
|
|
|
|
Decrease in cash
during the period
|
|
|
(6,742,031)
|
|
(675,034)
|
|
|
|
|
|
|
Cash and cash
equivalents beginning of the period
|
|
|
24,134,277
|
|
6,707,796
|
|
|
|
|
|
|
Cash and cash
equivalents end of the period
|
|
$
|
17,392,246
|
$
|
6,032,762
|
The Company's full financial statements and related MD&A for
the quarter ended September 30, 2018
are available at www.sedar.com.
About InMed:
InMed is a pre-clinical stage
biopharmaceutical company that specializes in developing novel
therapies through the research and development into the extensive
pharmacology of cannabinoids coupled with innovative drug delivery
systems. InMed's proprietary bioinformatics database drug/disease
targeting tool, cannabinoid biosynthesis technology and drug
development pipeline are the fundamental value drivers of the
Company. For more information, visit www.inmedpharma.com
About Epidermolysis Bullosa (EB). EB is a group of
rare diseases that cause fragile, blistering skin. The
blisters may appear in response to minor injury, even from heat,
rubbing, scratching or adhesive tape. In severe cases, the
blisters may occur inside the body, such as the lining of the mouth
or the stomach. Most types of epidermolysis bullosa are
inherited. The condition usually presents in infancy or early
childhood. Epidermolysis bullosa has no cure.
About INM-750. INM-750 is a proprietary, topical
cannabinoid product candidate targeted as a therapy in
epidermolysis bullosa (EB) and other potential dermatological and
wound-healing applications. It has been specifically designed with
the intent to: (i) modify the underlying cause of the disease in
certain patients with EB Simplex (EBS, the most common form of EB),
and (ii) to treat the major symptoms of the disease in all patients
with EB. Preclinical data generated previously demonstrates that
INM-750 may have a significant impact on certain symptoms of EB
(which may include improvement of wound area to promote healing,
reduction in pain, itch and inflammation, and providing
antimicrobial activity). These disease hallmarks are key
therapeutic targets for the effective treatment of EB as well as
several other dermatological conditions. Additionally, our data
indicate that INM-750 may have an impact on the underlying disease
by increasing the production of certain proteins, called keratins,
in the skin.
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: developing novel therapies for the
treatment of important diseases with high unmet medical needs;
beginning discussions of our clinical development plans with
regulatory authorities in the first half of 2019, with a CTA/IND
filing for INM-750 in the second half of 2019; being able to
produce multiple pharmaceutical-grade cannabinoids on a commercial
scale; the potential of INM-750 as a therapy in EB and for other
potential dermatological and wound-healing applications; and the
expected fundamental value drivers of the Company.
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: 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;
suitable partners may not be located; economic or market conditions
may worsen; and InMed's proprietary bioinformatics platform,
biosynthesis manufacturing process and drug development programs
may not deliver the expected level of results nor become the
fundamental value drivers of the Company. 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.