InMed Pharmaceuticals Reports Second Quarter Fiscal 2021 Financial Results
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.
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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 IntegraSyn(TM) 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 IntegraSyn(TM) 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.
IntegraSyn(TM):
-- 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 IntegraSyn(TM), 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
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
(unaudited)
As at December 31, 2020 and June 30, 2020
Expressed in U.S. Dollars
---
December 31,
June 30,
2020 2020
ASSETS
$
$
Current
Cash and cash
equivalents 10,020,853 5,805,809
Short-term
investments 45,225 42,384
Accounts receivable 154,846 45,344
Prepaids and other
assets 28,464 418,920
Total current assets 10,249,388 6,312,457
Non-Current
Property and
equipment, net 373,844 403,485
Intangible assets,
net 1,109,535 1,086,655
Other assets 14,655 -
---
Total Assets 11,747,422 7,802,597
===
LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payables and
accrued liabilities 2,077,325 1,607,303
Current portion of
lease obligations 76,312 68,965
Total current
liabilities 2,153,637 1,676,268
Non-current
Lease obligations 238,992 248,011
Derivative warrants
liability 1,763,980 -
Total Liabilities 4,156,609 1,924,279
Shareholders' Equity
Common shares, no par value, unlimited authorized
shares:
7,000,707 (June 30,
2020 -5,220,707)
issued and
outstanding 58,008,112 53,065,240
Additional paid-in
capital 17,946,374 17,764,333
Accumulated deficit (68,492,242) (64,649,381)
Accumulated other
comprehensive income
(loss) 128,569 (301,874)
---
Total Shareholders'
Equity 7,590,813 5,878,318
---
Total Liabilities and
Shareholders' Equity 11,747,422 7,802,597
===
Table 2: Condensed consolidated interim statements of operations and comprehensive loss (unaudited):
InMed Pharmaceuticals Inc
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited)
For the three and six months ended December 31, 2020 and
2019
Expressed in U.S. Dollars
---
Three Months Ended Six Months Ended
December 31
December 31
2020 2019 2020 2019
---
$
$
$
$
Operating Expenses
Research and development
and patents 937,948 1,606,831 1,849,104 3,568,743
General and administrative 959,554 871,745 1,584,342 1,759,256
Amortization and
depreciation 36,816 28,232 64,797 58,459
--- ---
Total operating expenses 1,934,318 2,506,808 3,498,243 5,386,458
Other Income (Loss)
Interest income 3,050 40,495 7,395 98,901
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)
--- ---
Net loss for the period (2,243,782) (2,493,495) (3,842,861) (5,298,807)
Other Comprehensive Loss
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) (0.68) (1.01)
Weighted average outstanding common shares
Basic and diluted 6,091,359 5,220,707 5,656,033 5,220,707
=== ===
Table 3: Condensed consolidated interim statements of cash flows (unaudited):
InMed Pharmaceuticals Inc.
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.
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SOURCE InMed Pharmaceuticals Inc.
