InMed Pharmaceuticals Reports Full Year Fiscal 2021 Financial Results and Provides Business Update
September 24 2021 - 7:30AM
InMed Pharmaceuticals Inc. (“InMed” or the
“Company”) (Nasdaq: INM), a leader in the manufacturing and
clinical development of rare cannabinoids, today reported financial
results for the fiscal year ended June 30, 2021.
Conference Call &
Webcast:Friday, September 24, 2021, at 8:00 AM Pacific
Time, 11:00 AM Eastern TimeUS/CANADA Participant Toll-Free Dial-In
Number: +1 (855) 605-1745US/CANADA Participant International
Dial-In Number: +1 (914) 987-7959Conference ID: 9373618Webcast:
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available for 90 days)
The Company’s full financial statements and
related MD&A for the fiscal year ended June 30, 2021, are
available at www.inmedpharma.com, www.sedar.com and at
www.sec.gov.
Eric A. Adams, InMed CEO, states, “In the final
quarter of our of fiscal year 2021, as well as throughout the year,
we made important progress in corporate development, pharmaceutical
drug development and in advancing our proprietary manufacturing
approach, IntegraSyn™. With the recent announcements regarding our
acquisition of BayMedica Inc., the Company is well positioned to
continue its activities to solidify a leadership position in the
field of rare cannabinoids.”
Business Update:
-
Corporate Development. On June 29, 2021, the
Company announced it had entered into a
non-binding letter of intent (the "LOI") to
acquire BayMedica Inc. (“BayMedica”), a private company based in
the U.S. that specializes in the manufacture and commercialization
of rare cannabinoids and on September 13, 2021, the Company
announced the signing of a Definitive Agreement (“Definitive
Agreement”) related to the acquisition. The transaction, which is
subject to certain standard closing conditions, is expected to
close in the coming weeks. Upon closing, InMed will become a global
leader in the manufacturing of rare cannabinoids, with expertise in
three distinct and complementary cannabinoid manufacturing
approaches. InMed’s proprietary cannabinoid manufacturing process,
IntegraSyn™, combined with BayMedica’s synthetic biology and
chemical synthesis capabilities, will provide InMed with the
requisite flexibility to select the most appropriate,
cost-effective manufacturing method based on the target cannabinoid
and appropriate quality specifications for the desired market
segment. In addition to cannabinoid manufacturing, the combined
company will continue to explore the therapeutic potential of
cannabinoids and novel cannabinoid analogs for pharmaceutical drug
development, as well as expand commercial sales of rare
cannabinoids to the consumer health and wellness sector.
-
IntegraSynTM. On
April 26, 2021, the Company announced that its IntegraSyn™
cannabinoid manufacturing approach had achieved a level of 2g/L
cannabinoid yield, a milestone that signaled commercial viability
and supported the advancement to large-scale commercial production.
Subsequent to this, on June 17, 2021, InMed announced that its
continued optimization of IntegraSyn™ had resulted in increasing
the cannabinoid yield to a level of 5 g/L, significantly
exceeding currently reported industry yields and further improving
the economics of this proprietary manufacturing approach. The
impact of improved yield is a significant reduction in the overall
cost of manufacturing due to increased cannabinoid production per
batch. InMed is now focused on manufacturing scale-up to larger
batch sizes.
- INM-755
for the treatment of epidermolysis bullosa (“EB”). On
April 28, 2021, InMed announced it had filed Clinical Trial
Applications (“CTAs”) in multiple countries for its multi-site
Phase 2 clinical trial of INM-755 (cannabinol) cream in
Epidermolysis Bullosa (“EB”). To date, CTA’s have now been filed in
all 7 participating countries: Austria, France, Germany, Greece,
Italy, Israel and Serbia. This INM-755-201 study is designed to
enroll up to 20 patients, conservatively within 12 months. All four
subtypes of inherited EB, being EB Simplex, Dystrophic EB,
Junctional EB, and Kindler Syndrome, are eligible for this study in
which InMed will evaluate the safety of INM-755 (cannabinol) cream
and its preliminary efficacy in treating symptoms and wound healing
over a 28-day period. The study will use a within-patient,
double-blind design whereby matched index areas will be randomized
to be treated with either INM-755 (cannabinol) cream or vehicle
cream as a control. The Company anticipates the patient
enrollment to start in the coming weeks.
- INM-088
for the treatment of glaucoma. On August
17, 2021, InMed presented preclinical data at the H.C. Wainwright
Ophthalmology Conference demonstrating that cannabinol was
effective at providing neuroprotection to the retina ganglion cells
and reducing intraocular pressure in glaucoma models. Over the past
quarter, InMed has continued to set up a larger scale drug product
manufacturing process, completed dose-ranging studies and conducted
topline clinical design work with its clinical research
organization. The drug product produced from the larger scale will
be used to support the upcoming GLP studies while the dose-ranging
studies will assist in providing guidance on the appropriate dosing
level and regimen needed for the GLP studies. Currently, we
anticipate the GLP studies to be completed by mid-2022.
Financing Activities and Results of
Operations (expressed in US Dollars):
- On April 27, 2021, InMed announced
that, based on the strong trading data on the Nasdaq, it had
provided written notice to the Toronto Stock
Exchange (the "TSX") regarding the voluntary delisting of its
common shares. InMed’s common shares were delisted from the TSX at
the close of trading on May 7, 2021. InMed’s common shares continue
to be listed and tradable on the Nasdaq under the symbol
“INM”.
- On June 29, 2021, the Company
announced that it had entered into securities purchase agreement
with an institutional investor to raise approximately US$12.0
million and on July 2, 2021, the Company announced that it had
closed the private placement. Under the terms of the private
placement, an aggregate of 4,036,327 common shares (or common share
equivalents in lieu thereof) and warrants to purchase up to an
aggregate of 4,036,327 common shares, at an effective purchase
price of US$2.973 per common share (or common stock equivalent in
lieu thereof) and associated warrant. The warrants have an exercise
price of US$2.848 per share, are exercisable immediately and have a
term of five years. After deducting the placement agent fees and
estimated offering expenses payable by the Company, the Company
received net proceeds of approximately US$11.0 million.
- For the year ended June 30, 2021,
the Company recorded a net loss of $10.2 million, or $1.52 per
share, compared with a net loss of $8.9 million, or $1.71 share,
for the year ended June 30, 2020.
- Research and development and
patents expenses were $5.3 million for the year ended June 30,
2021, compared with $5.8 million for the year ended June 30, 2020.
The reduction in research and development and patents expenses was
primarily due to decreased purchases of the active pharmaceutical
ingredients used in INM-755 clinical trials. In addition,
share-based payments were $0.3 million lower for the year ended
June 30, 2021 while contract research organization (“CRO”)
expenditures increased by $0.2 million relative to the prior
year.
- The Company incurred general and
administrative expenses of $4.5 million for the year ended June 30,
2021, compared with $3.2 million for the year ended June 30, 2020.
The increase results from a combination of changes including
substantially higher insurance fees and higher personnel expenses,
partially offset by lower share-based payments and lower investor
relation expenses.
- The Company also incurred non-cash,
share-based payments in connection with the grant of stock options,
of $0.6 million for the year ended June 30, 2021 compared with $1.0
million for the year ended June 30, 2020. Share-based payments
amounts are included within research and development expenses and
general and administrative expenses.
- At June 30, 2021, the Company’s
cash, cash equivalents and short-term investments were $7.4
million, which compares to $5.8 million at June 30, 2020. The
increase in cash, cash equivalents and short-term investments
during the year ended June 30, 2021, was primarily the result of
the November 16, 2020 public offering and the February 16, 2021
private placement partially offset by cash outflows from operating
activities.
- At June 30, 2021, the Company’s
total issued and outstanding shares were 8,050,707. During the year
ended June 30, 2021, the weighted average number of common shares
was 6,719,830, which is used for the calculation of loss per share
for the year.
Table 1: Consolidated statements of
financial position:
InMed Pharmaceuticals Inc. |
|
|
CONSOLIDATED BALANCE SHEETS |
|
|
As at June 30, 2021 and 2020 |
|
|
Expressed in U.S. Dollars |
|
|
|
June 30, |
|
June 30, |
|
|
2021 |
|
2020 |
|
|
|
|
ASSETS |
$ |
|
$ |
|
Current |
|
|
Cash and cash
equivalents |
7,363,126 |
|
5,805,809 |
|
Short-term
investments |
46,462 |
|
42,384 |
|
Accounts receivable |
11,919 |
|
45,344 |
|
Prepaids and other
assets |
956,762 |
|
418,920 |
|
Total current assets |
8,378,269 |
|
6,312,457 |
|
|
|
|
Non-Current |
|
|
Property and equipment,
net |
326,595 |
|
403,485 |
|
Intangible assets,
net |
1,061,697 |
|
1,086,655 |
|
Other assets |
14,655 |
|
- |
|
Total Assets |
9,781,216 |
|
7,802,597 |
|
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
Current |
|
|
Accounts payables and accrued
liabilities |
2,134,878 |
|
1,607,303 |
|
Current portion of lease
obligations |
80,483 |
|
68,965 |
|
Total current liabilities |
2,215,361 |
|
1,676,268 |
|
|
|
|
Non-current |
|
|
Lease obligations |
189,288 |
|
248,011 |
|
Total Liabilities |
2,404,649 |
|
1,924,279 |
|
|
|
|
Shareholders' Equity |
|
|
Common shares, no par value, unlimited
authorized shares: |
|
8,050,707 (June 30, 2020 - 5,220,707)
issued and outstanding |
60,587,417 |
|
53,065,240 |
|
Additional paid-in capital |
21,513,051 |
|
17,764,333 |
|
Accumulated deficit |
(74,852,470 |
) |
(64,649,381 |
) |
Accumulated other comprehensive income
(loss) |
128,569 |
|
(301,874 |
) |
Total Shareholders' Equity |
7,376,567 |
|
5,878,318 |
|
Total Liabilities and Shareholders'
Equity |
9,781,216 |
|
7,802,597 |
|
Table 2: Consolidated statements of operations and
comprehensive loss:
InMed Pharmaceuticals Inc. |
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
For the year ended June 30, 2021 and 2020 |
|
|
Expressed in U.S. Dollars |
|
|
|
Year Ended |
|
June 30 |
|
2021 |
|
2020 |
|
|
$ |
|
$ |
|
Operating Expenses |
|
|
Research and development and
patents |
5,338,084 |
|
5,811,266 |
|
General and
administrative |
4,479,333 |
|
3,227,167 |
|
Amortization and
depreciation |
120,866 |
|
112,429 |
|
Total operating expenses |
9,938,283 |
|
9,150,862 |
|
|
|
|
Other Income (Loss) |
|
|
Interest income |
16,017 |
|
129,526 |
|
Finance expense |
(360,350 |
) |
- |
|
Unrealized gain on derivative
warrants liability |
242,628 |
|
- |
|
Foreign exchange (loss)
gain |
(163,101 |
) |
82,187 |
|
Net loss for the period |
(10,203,089 |
) |
(8,939,149 |
) |
|
|
|
Other Comprehensive Loss |
|
|
Foreign currency translation gain
(loss) |
430,443 |
|
(419,838 |
) |
Total comprehensive loss for the
period |
(9,772,646 |
) |
(9,358,987 |
) |
|
|
|
Net loss per share for the
year |
|
|
Basic and
diluted |
(1.52 |
) |
(1.71 |
) |
Weighted average outstanding common
shares |
|
|
Basic and
diluted |
6,719,830 |
|
5,220,707 |
|
Table 3: Consolidated statements of cash
flows:
InMed Pharmaceuticals Inc. |
|
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
|
|
For the years ended June 30, 2021 and 2020 |
|
|
Expressed in U.S. Dollars |
|
|
|
2021 |
|
2020 |
|
|
|
|
Cash provided by (used in): |
$ |
|
$ |
|
|
|
|
Operating Activities |
|
|
Net loss for the period |
(10,203,089 |
) |
(8,939,149 |
) |
Items not requiring cash: |
|
|
Amortization and
depreciation |
120,866 |
|
112,429 |
|
Share-based
compensation |
610,193 |
|
994,401 |
|
Non-cash lease
expense |
107,828 |
|
89,816 |
|
Loss on disposal of
assets |
555 |
|
2,307 |
|
Received interest income on
short-term investments |
131 |
|
79,937 |
|
Unrealized gain on derivative
warrants liability |
(242,628 |
) |
- |
|
Unrealized foreign exchange
gain |
(445 |
) |
- |
|
Payments on lease obligations |
(93,951 |
) |
(72,522 |
) |
Finance expense |
360,350 |
|
- |
|
Changes in non-cash working capital: |
|
- |
|
Prepaids and other
assets |
(823,172 |
) |
(126,560 |
) |
Other non-current
assets |
(14,161 |
) |
- |
|
Accounts receivable |
40,198 |
|
17,273 |
|
Accounts payable and accrued
liabilities |
346,685 |
|
467,392 |
|
Total cash used in operating
activities |
(9,790,640 |
) |
(7,374,676 |
) |
|
|
|
Investing Activities |
|
|
Maturity of short-term
investments |
- |
|
3,876,269 |
|
Purchase of short-term
investments |
- |
|
(43,619 |
) |
Proceeds on disposal of property
and equipment |
- |
|
541 |
|
Purchase of property and
equipment |
(1,725 |
) |
(42,573 |
) |
Total cash (used in) provided by investing
activities |
(1,725 |
) |
3,790,618 |
|
|
|
|
Financing Activities |
|
|
Shares issued for
cash |
12,472,500 |
|
- |
|
Share issuance costs |
(1,617,778 |
) |
(30,993 |
) |
Total cash provided by (used in) financing
activities |
10,854,722 |
|
(30,993 |
) |
Effects of foreign exchange on cash and cash
equivalents |
494,960 |
|
(416,353 |
) |
Increase (decrease) in cash during the
period |
1,557,317 |
|
(4,031,404 |
) |
Cash and cash equivalents beginning of the
period |
5,805,809 |
|
9,837,213 |
|
Cash and cash equivalents end of the
period |
7,363,126 |
|
5,805,809 |
|
About InMed: InMed
Pharmaceuticals is a clinical-stage company developing a pipeline
of cannabinoid-based pharmaceutical drug candidates, initially
focused on the therapeutic benefits of cannabinol (“CBN”) and is
developing IntegraSyn™ to produce pharmaceutical-grade
cannabinoids. The Company is dedicated to delivering new
therapeutic alternatives to patients that may benefit from
cannabinoid-based pharmaceutical drugs. For more information,
visit www.inmedpharma.com.
Investor Contact: Colin ClancySenior Director,
Investor RelationsT: +1 604 416 0999E: cclancy@inmedpharma.com
Edison Group:Joe Green/Laine YonkerT:
+1.646.653.7030/+1.646.653.7035E: jgreen@edisongroup.com /
lyonker@edisongroup.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; leading the clinical
development of cannabinol as a potential therapeutic option for
diseases; solidifying a leadership position in the field of rare
cannabinoids including in the manufacturing of rare cannabinoids;
scaling-up IntegraSyn™ to larger batch sizes; evaluating the safety
of INM-755 (cannabinol) cream and its preliminary efficacy in the
INM-755-201 study; commencing patient enrollment the INM-755-201
study in the coming weeks; and completing INM-088 GLP studies by
mid-2022.
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 Form 10-K filed
on sec.gov.
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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