VANCOUVER, May 15, 2019 /CNW/ - InMed
Pharmaceuticals Inc. ("InMed" or the "Company") (TSX:IN;
OTCQX:IMLFF), a biopharmaceutical company developing a proprietary
biosynthesis platform technology for the manufacturing of
pharmaceutical-grade cannabinoids as well as an R&D pipeline of
medications targeting diseases with high unmet medical needs, today
reported financial results for the three and nine months ended
March 31, 2019, which is the
Company's third quarter of fiscal year 2019 ("3Q19").
Eric A. Adams, InMed's President
and Chief Executive Officer, commented, "The third quarter of
fiscal year 2019 was all about execution: the team is firing
on all cylinders, R&D milestones are being accomplished, and we
remain enthusiastic about our scientific advancements.
Further, our financial position remains strong and we are confident
that our existing cash runway positions us to complete our
forthcoming significant milestones – specifically to advance our
INM-755 program for the treatment of epidermolysis bullosa ("EB")
through the completion of Phase I healthy volunteer studies, to
advance our biosynthesis program in preliminary commercial scale-up
activities, and to advance the glaucoma program through several
pre-clinical studies."
"During the third quarter," Mr. Adams continued, "we
transitioned our EB program to a single cannabinoid formulation,
which is now referred to as INM-755. This was an important
decision for the program, as we believe a single molecule product,
instead of a combination product, will improve our overall
probability of success, both in terms of clinical development as
well as from a regulatory standpoint. In terms of our
preparation for our Phase I study, we have finalized our selection
of the service provider for our final sterile cream
production."
"With regard to our proprietary biosynthesis platform
technology," Mr. Adams continued, "we completed a number of
important milestones and made meaningful advancements on several
others:
- Completed the tech transfer from our collaboration partners at
the University of British Columbia
("UBC") to the National Research Council Canada ("NRC") by
successfully converting precursors into a specific cannabinoid
using the appropriate DNA plasmid construct in E. coli.
- Initiated downstream process ("DSP") activities involving
purification of cannabinoids from the fermented material at a
GMP-ready contract development and manufacturing operation
(CDMO).
- Published the first in a series of pending patent applications
directed to the Company's biosynthesis platform technology for the
manufacturing of pharmaceutical-grade cannabinoids. The first
of which, entitled 'METABOLIC ENGINEERING OF E. COLI FOR THE
BIOSYNTHESIS OF CANNABINOID PRODUCTS', addresses the enablement and
maximization of cannabinoid production through optimization of the
precursor substrates needed to support specific cannabinoid
synthesis. This application and two more recently filed U.S.
provisional patent applications cover various elements required to
enable functional cannabinoid synthase production in an E.
coli system."
Mr. Adams continued, "In the near term, we expect to complete
the fermentation optimization initiative, to complete the process
development of the DSP and to scale-up fermentation batches towards
commercial scale. Finally, we will continue to pursue various
avenues to maximize the yields and to lower the costs of
cannabinoid manufacturing."
Results of Operations (expressed in Canadian
Dollars):
- For 3Q19, the Company recorded a comprehensive net loss of
$3.5 million, or $0.02 per share, compared with a comprehensive
net loss of $2.1 million, or
$0.01 per share, for the three months
ended March 31, 2018 ("3Q18").
- Research and development expenses were $1.6 million for 3Q19, compared with $0.6 million for 3Q18. The increase in
research and development expenses in 3Q19 as compared to 3Q18 was
primarily due to: (a) increased spending on research supplies for
the purchase of active pharmaceutical ingredients to be used in the
clinical trial for INM-755; (b) increased spending on external
contractors for work associated with preclinical studies for
INM-755 required for the regulatory application to initiate
clinical trials for INM-755 in the second half of calendar year
2019; (c) increased spending on the Company's biosynthesis program;
and (d) increased R&D personnel compensation as a result of
increased R&D staffing.
- The Company incurred general and administrative expenses of
$1.0 million for 3Q19, compared with $0.8 million for 3Q18.
The increase in general and administrative expenses in 3Q19
as compared to 3Q18 was primarily due to increased personnel
compensation that reflects increased staffing, reflective of the
growth in the Company's operations.
- At March 31, 2019, the Company's cash, cash equivalents and
short-term investments were $20.4 million, which compares to $23.0
million at December 31, 2018.
- At March 31, 2019, the Company's total issued and outstanding
shares were 172,133,633. Including outstanding stock options
and warrants, as at March 31, 2019, the Company had 222,648,790
shares on a diluted basis. During 3Q19, the weighted average
number of common shares was 171,328,077, which is used for the
calculation of loss per share.
Conference Call & Webcast:
Wednesday, May 15,
2019 at 10:00 AM Pacific Time, 1:00 PM Eastern Time
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Toronto:
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+1.416.764.8688
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Vancouver:
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North America (Toll
Free):
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+1.888.390.0546
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Conference
ID:
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17193517
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Webcast:
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https://event.on24.com/wcc/r/1999675/955779A89027D040E64A5A3804E51DBE
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Replays, Available through May 22,
2019:
Toronto:
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+1.416.764.8677
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North America (Toll
Free):
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+1.888.390.0541
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Playback
Passcode:
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193517 #
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The Company's full financial statements and related MD&A for
the three months ended March 31, 2019
will be available at www.sedar.com on May
15, 2019.
Table 1: Condensed consolidated interim statements
of financial position
(unaudited):
InMed
Pharmaceuticals Inc.
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|
|
|
|
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CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(unaudited)
|
As at March 31, 2019
and June 30, 2018
|
|
|
|
|
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Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
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March
31
|
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June 30
|
|
|
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2019
|
|
2018
|
|
|
|
|
|
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ASSETS
|
|
|
|
|
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Current
|
|
|
|
|
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Cash and cash
equivalents
|
|
$
|
12,931,236
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$
|
24,134,277
|
Short-term
investments
|
|
|
7,440,225
|
|
2,342,615
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Accounts
receivable
|
|
|
76,886
|
|
53,373
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Prepaids and
advances
|
|
|
649,179
|
|
203,477
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Total current
assets
|
|
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21,097,526
|
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26,733,742
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|
|
|
|
|
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Non-Current
|
|
|
|
|
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Property and
equipment
|
|
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47,478
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|
55,732
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Intangible
assets
|
|
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1,205,441
|
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1,273,670
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|
|
|
|
|
|
|
|
|
|
|
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Total
Assets
|
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$
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22,350,445
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$
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28,063,144
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|
|
|
|
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LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
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Current
|
|
|
|
|
|
Trade
payables
|
|
|
667,786
|
|
937,759
|
|
|
|
|
|
|
|
|
|
|
|
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SHAREHOLDERS'
EQUITY
|
|
|
|
|
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Share
capital
|
|
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68,454,340
|
|
68,058,698
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Contributed
surplus
|
|
|
13,528,757
|
|
10,381,759
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Accumulated
deficit
|
|
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(60,300,438)
|
|
(51,315,072)
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|
|
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21,682,659
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|
27,125,385
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|
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$
|
22,350,445
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$
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28,063,144
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Table 2: Condensed consolidated interim statements
of comprehensive loss (unaudited):
InMed
Pharmaceuticals Inc.
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|
|
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|
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|
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CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(unaudited)
|
|
|
|
|
For the three and
nine months ended March 31, 2019 and 2018
|
|
|
|
|
|
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Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months
Ended
|
|
Nine Months
Ended
|
|
|
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March 31
|
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March 31
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
|
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General and
administrative
|
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$
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988,632
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$
|
814,982
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$
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2,723,265
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$
|
2,391,617
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Research and
development
|
|
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1,615,729
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|
554,750
|
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3,189,671
|
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1,350,182
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Amortization and
depreciation
|
|
|
31,538
|
|
30,088
|
|
94,267
|
|
87,123
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Foreign exchange
(gain) loss
|
|
|
72,978
|
|
2,846
|
|
(18,024)
|
|
5,842
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Share-based
payments
|
|
|
890,581
|
|
758,350
|
|
3,337,640
|
|
1,691,722
|
|
|
|
|
|
|
|
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Total
expenses
|
|
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3,599,458
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|
2,161,016
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9,326,819
|
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5,526,486
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|
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|
|
|
|
|
|
|
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Interest
income
|
|
|
108,887
|
|
33,059
|
|
341,453
|
|
34,766
|
|
|
|
|
|
|
|
|
|
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Total
comprehensive loss for the period
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$
|
(3,490,571)
|
$
|
(2,127,957)
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$
|
(8,985,366)
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$
|
(5,491,720)
|
|
|
|
|
|
|
|
|
|
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Basic and diluted
loss per share for
the period
|
|
$
|
-
0.02
|
$
|
-
0.01
|
$
|
-
0.05
|
$
|
-
0.04
|
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 nine months
ended March 31, 2019 and 2018
|
|
|
|
|
Expressed in Canadian
Dollars
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
Cash flows from
operating activities
|
|
|
|
|
|
Loss for the
period
|
|
$
|
(8,985,366)
|
$
|
(5,491,720)
|
Adjustments to
reconcile loss to net cash used in operating activities
|
|
|
|
|
|
Amortization and
depreciation
|
|
|
94,267
|
|
87,123
|
Share-based
payments
|
|
|
3,337,640
|
|
1,691,722
|
Accrued interest
income on short-term investments
|
|
(68,860)
|
|
(2,905)
|
|
|
|
|
|
|
Changes in non-cash
working capital balances:
|
|
|
|
|
Prepaids and
advances
|
|
|
(445,702)
|
|
136,015
|
Accounts
receivable
|
|
|
(23,513)
|
|
8,643
|
Trade
payables
|
|
|
(269,973)
|
|
266,480
|
|
|
|
|
|
|
Total cash
outflows from operating activities
|
|
(6,361,507)
|
|
(3,304,642)
|
|
|
|
|
|
|
Cash Flows From
Investing Activities
|
|
|
|
|
|
Purchase of
short-term investments
|
|
|
(5,028,750)
|
|
(2,328,750)
|
Purchase of property
and equipment
|
|
|
(17,784)
|
|
(55,639)
|
|
|
|
|
|
|
Total cash
outflows from investing activities
|
|
(5,046,534)
|
|
(2,384,389)
|
|
|
|
|
|
|
Cash Flows From
Financing Activities
|
|
|
|
|
|
Shares issued for
cash
|
|
|
205,000
|
|
11,299,881
|
Share issue
costs
|
|
|
-
|
|
(768,675)
|
|
|
|
|
|
|
Cash provided by
financing activities
|
|
|
205,000
|
|
10,531,206
|
|
|
|
|
|
|
Increase (decrease)
in cash during the period
|
|
(11,203,041)
|
|
4,842,175
|
|
|
|
|
|
|
Cash and cash
equivalents beginning of the period
|
|
24,134,277
|
|
6,707,796
|
|
|
|
|
|
|
Cash and cash
equivalents end of the period
|
$
|
12,931,236
|
$
|
11,549,971
|
About InMed:
InMed Pharmaceuticals is a
biopharmaceutical company developing a proprietary biosynthesis
system for the manufacturing of pharmaceutical-grade cannabinoids,
as well as a pipeline of cannabinoid-based medications that target
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.
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 a proprietary biosynthesis
platform technology for the manufacturing of pharmaceutical-grade
cannabinoids as well as an R&D pipeline of medications
targeting diseases with high unmet medical needs; the ability of
our existing cash runway to position us to complete our forthcoming
significant milestones, including advancing our INM-755 program
through the completion of Phase I healthy volunteer studies,
advancing our biosynthesis program in preliminary commercial
scale-up activities, and advancing the glaucoma program through
several pre-clinical studies; the ability of a single molecule
product (INM-755), instead of a combination product, to improve our
overall probability of success; in the near term, completing the
fermentation optimization initiative, completing the process
development of the DSP, and scaling-up fermentation batches towards
commercial scale; continuing to pursue various avenues to
maximize the yields and to lower the costs of cannabinoid
manufacturing.
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;
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; INM-755 may not be as successful as desired, if at all;
completion of the fermentation optimization initiative, completion
of the process development of the DSP, and scaling-up fermentation
batches towards commercial scale may not be completed in the near
term, if at all; and the development of a proprietary biosynthesis
platform technology for the manufacturing of pharmaceutical-grade
cannabinoids as well as an R&D 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.