InMed Pharmaceuticals Inc. (“InMed” or the
“Company”) (Nasdaq: INM), a leader in the research, development,
manufacturing and commercialization of rare cannabinoids, today
announced financial results for the third quarter of the fiscal
year 2022 which ended March 31, 2022.
“The third quarter of fiscal 2022 saw noticeable
advancements across all of our programs, including commencing sales
of the rare cannabinoids CBDV and CBT as raw ingredients for the
health and wellness industry,” says Eric A. Adams, InMed President
& CEO. “For the remainder of fiscal 2022, we will remain
focused on driving our commercial operations by expanding our
product portfolio, increasing sales of our existing and new rare
cannabinoids, exploring new distribution channels and optimizing
our product development and supply chain strategy. We continue to
grow revenues and have established a solid platform upon which to
build as we commercialize additional high value products. We
continue to focus on enhancing our sales and marketing efforts to
support increasing demand.”
Business Update
Commercial ActivitiesIn January
2022, InMed announced that it launched B2B sales of
cannabicitran (“CBT”) to wholesalers, suppliers and
end-product manufacturers in the health and wellness sector via its
wholly-owned subsidiary, BayMedica LLC. Subsequent to the quarter
end, the Company also commenced sales of the rare cannabinoid
cannabidivarin (“CBDV”) in April, marking the third product in the
Company’s rare cannabinoid commercial portfolio, which also
includes cannabichromene (“CBC”). BayMedica has also begun
commercial scale production of its delta-9 dominant
tetrahydrocannabivarin (“THCV”) in anticipation of commencing B2B
sales. CBDV and THCV are highly anticipated, non-intoxicating rare
cannabinoids for which is there is growing interest.
Continuing to build out a robust product
portfolio is a strategic priority and the Company currently has
several additional high-value rare cannabinoids in various stages
of development and commercial manufacturing scale-up.
By establishing a reliable supply of these rare
cannabinoids at commercial scale, innovative product manufacturers
and consumer brands now have the ability to deliver improved and
differentiated products via product line extensions and
formulations designed to increase the performance of their
products.
In addition to sales of rare cannabinoids as raw
ingredients, the Company is also evaluating potential partners and
co-development collaborations for novel product development.
Formulated cannabinoid products in different delivery forms can
help to expand product development options for manufacturers of
health and wellness products.
Also following the quarter’s end, BayMedica
announced they will be supplying the rare cannabinoid THCV for
incorporation into Trokie’s proprietary product formulation. This
will then be evaluated in Radicle Science’s “Radicle Energy” study
on energy, focus/attention, appetite and weight/body mass index
(“BMI”). The study is being conducted to provide valuable third
party validation to the use case of THCV. Advancing the scientific
research and education of rare cannabinoids is a key part of
InMed’s commitment to building the framework that supports the
Company’s long-term commercial strategy.
To support our commercial efforts, in February
the Company appointed seasoned business executive, Jerry P.
Griffin, as VP of Sales and Marketing. Mr. Griffin has a wealth of
experience across various markets and with numerous cannabinoid
products, and a proven track record as a seasoned sales executive.
He has held several senior positions at both privately and publicly
held companies including Fortune 500 companies as a strong
strategic leader and has the requisite experience to oversee the
commercial ramp-up of B2B sales of rare cannabinoids products to
the consumer health and wellness market.
Pharmaceutical Development
Programs
INM-755 for the treatment of
Epidermolysis Bullosa (“EB”)Enrollment and patient
treatment of the Company’s Phase 2 clinical trial, 755-201-EB, of
INM-755 (cannabinol) cream in the treatment of EB, commenced in
December of 2021 and is expected to complete during the calendar
year 2022. An update on the progress of the EB program is expected
in the coming weeks.
The 755-201-EB study is designed to enroll up to
20 patients. InMed is evaluating the safety of INM-755 (cannabinol)
cream and its preliminary efficacy in treating symptoms and wound
healing over a 28-day treatment period. This study marks the first
time cannabinol (“CBN”) has advanced to a Phase 2 clinical trial to
be investigated as a therapeutic option to treat a disease.
INM-088 for the treatment of
glaucomaThe Company recently completed a
pre-Investigational New Drug (“pIND”) application discussion with
the U.S. Food and Drug Administration (“FDA”) regarding
manufacturing, preclinical studies and early clinical development
plans for INM-088, a cannabinol (“CBN”) formulation in development
for glaucoma. The Company has gained alignment with FDA on the
design of the initial Phase 1-2 clinical trial to gather
preliminary data on the safety and efficacy of INM-088 treatment.
The FDA has provided guidance for the development program based on
a summary of the available preclinical data, clinical safety data
for CBN from the INM-755 program, study designs for additional
IND-enabling preclinical studies, and Chemistry Manufacturing and
Controls (“CMC”) information. Management expects to file regulatory
applications in the first half of the calendar year 2023, to
initiate a human clinical trial.
The Company continues to advance its
pre-clinical research on CBN as a treatment for glaucoma. As
referenced in a recent international journal, InMed’s research
demonstrates that CBN was effective at providing neuroprotection to
the retinal ganglion cells and reducing intraocular pressure in
glaucoma models and outperforming several other naturally occurring
cannabinoids.
New Cannabinoid AnalogsIn April
2022, the Company announced the publication of a patent application
in North America for several cannabinoid analogs. This patent
application has broad claims directed to their molecular structure,
uses and methods of manufacturing. The patent application covers
technology that allows for the creation of libraries of new
chemical entities (“NCEs”), which the Company will screen in
several in vitro and in vivo models to select therapeutic
candidates for advancement. Unlike natural cannabinoids isolated
from the plant which are not patentable, these cannabinoid analogs
are patentable and may create potential value for the
Company.
In addition, the Company also initiated a
research collaboration agreement with the Department of
Biotechnological and Applied Clinical Sciences, University of
L’Aquila (Italy) in the laboratory of Dr. Mauro Maccarrone. Dr.
Maccarrone’s lab will be screening the Company’s novel cannabinoid
analogs to investigate pharmacological properties and potential
therapeutic uses.
Corporate
Today the Company would like to announce that
Mr. Bryan Baldasare has joined the Board of Directors effective
immediately.
Mr. Baldasare is a well-rounded biotech
executive with wealth of experience in finance and accounting,
financial planning and analysis, treasury management, commercial
operations and mergers and acquisitions. Mr. Baldasare spent over
20 years at Meridian Bioscience, most recently as Chief Financial
Officer where during his tenure, grew its revenues by over 500%,
developed and launched dozens of new products, expanded into a
diversified global business with 15 sites in 10 countries. Mr.
Baldasare is currently the CFO at Hilltop Companies, a leading
supplier to the construction industry. Prior to Meridian, Mr.
Baldasare spent over 10 years in public accounting at Arthur
Andersen LLP. Mr. Baldasare has a Bachelor’s degree in Business
Administration from the University of Cincinnati.
As noted earlier, in February, the Company also
appointed Jerry Griffin as VP of Sales and Marketing.
Financial and Operational
Highlights:
For the 9 months ended March 31, 2022, the
Company recorded a net loss of $10.7 million, or $0.81 per share,
compared with a net loss of $6.9 million, or $1.11 per share, for
the nine months ended March 31, 2021.
Research and development and patents expenses
increased by $2.2 million for the nine months ended March 31, 2022
compared to the nine months ended March 31, 2021. The increase in
research and development and patents expenses was primarily due to
increased activities related to the INM-755 clinical trial and the
addition of $0.9 million in our BayMedica segment following the
acquisition date.
The Company incurred general and administrative
expenses of $5.1 million for the nine months ended March 31, 2022
compared with $2.9 million for the nine months ended March 31,
2021. The increase results primarily from the inclusion of
BayMedica operating results following the acquisition date and
combination of changes including legal fees and investor relation
expenses, personnel expenses, substantially higher insurance fees
resulting from our listing on the Nasdaq Capital Market. In
addition, acquisition-related expenses, which were comprised of
regulatory, financial advisory and legal fees, totaled $0.2 million
for the nine months ended March 31, 2022 and were included in
general and administrative expenses in our InMed segment.
At March 31, 2022, the Company’s cash, cash
equivalents and short-term investments were $5.9 million, which
compares to $7.4 million at June 30, 2021. The change in cash, cash
equivalents and short-term investments during the nine months to
March 31, 2022, was primarily the result of the July 2, 2021
private placement partially offset by cash outflows from operating
activities.
At March 31, 2022, the Company's total
issued and outstanding shares were 14,283,848. During the three and
nine months ending March 31, 2022, the weighted average number
of common shares was 14,151,544 and 13,326,754, which is used for
the calculation of loss per share for the respective interim
periods.
BayMedica RevenueResults
subsequent the acquisition of BayMedica in October 2021, are net
sales of $0.6 million for the six months ended March 31, 2022 for
cannabinoid ingredient sales to wholesalers and product
manufacturers in the health and wellness sector. As the nine months
ended March 31, 2021 pre-dated the acquisition of BayMedica there
are no comparable revenues in the 2021 period. Accordingly, we
realized cost of goods sold of $0.3 million for the nine months
ended March 31, 2022, with no comparable expenses in 2021,
resulting in a gross profit of $0.3 million for the period.
Reported sales were impacted this quarter by a
delay in the product launches of two new rare cannabinoids, CBDV
and THCV. CBDV was launched subsequent to quarter end and the
commercial launch of THCV is planned shortly. With the
commercialization of these products and additional launches being
planned, the Company anticipates revenue growth in the coming
quarters.
Table 1: Condensed Consolidated Interim
Balance Sheets (unaudited):
InMed Pharmaceuticals Inc. |
|
|
|
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
(unaudited) |
|
|
As at March 31, 2022 and June 30, 2021 |
|
|
|
Expressed in U.S. Dollars |
|
|
|
|
March 31, |
|
June 30, |
|
|
|
2022 |
|
2021 |
|
|
|
|
|
|
ASSETS |
$ |
|
$ |
|
|
Current |
|
|
|
Cash and cash
equivalents |
5,898,313 |
|
7,363,126 |
|
|
Short-term
investments |
46,098 |
|
46,462 |
|
|
Accounts receivable |
70,554 |
|
11,919 |
|
|
Inventories |
1,420,382 |
|
- |
|
|
Prepaids and other
assets |
1,311,539 |
|
956,762 |
|
|
Total current assets |
8,746,886 |
|
8,378,269 |
|
|
|
|
|
|
Non-Current |
|
|
|
Property and equipment,
net |
1,002,846 |
|
326,595 |
|
|
Intangible assets,
net |
2,355,401 |
|
1,061,697 |
|
|
In-process research and
development |
1,249,000 |
|
- |
|
|
Goodwill |
2,023,039 |
|
- |
|
|
Other assets |
108,625 |
|
14,655 |
|
|
Total Assets |
15,485,797 |
|
9,781,216 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
|
Current |
|
|
|
Accounts payable and accrued
liabilities |
2,866,927 |
|
2,134,878 |
|
|
Short-term debt |
29,312 |
|
- |
|
|
Current portion of lease
obligations |
399,904 |
|
80,483 |
|
|
Deferred revenue |
8,902 |
|
- |
|
|
Acquisition consideration
payable |
800,457 |
|
- |
|
|
Total current liabilities |
4,105,502 |
|
2,215,361 |
|
|
|
|
|
|
Non-current |
|
|
|
Lease obligations |
493,562 |
|
189,288 |
|
|
Total Liabilities |
4,599,064 |
|
2,404,649 |
|
|
|
|
|
|
Shareholders' Equity |
|
|
|
Common shares, no par value, unlimited
authorized shares: |
|
|
|
14,283,848 (June 30, 2021 - 8,050,707)
issued and outstanding |
69,825,331 |
|
60,587,417 |
|
|
Additional paid-in capital |
26,515,397 |
|
21,513,051 |
|
|
Accumulated deficit |
(85,582,564 |
) |
(74,852,470 |
) |
|
Accumulated other comprehensive
income |
128,569 |
|
128,569 |
|
|
Total Shareholders' Equity |
10,886,733 |
|
7,376,567 |
|
|
Total Liabilities and Shareholders'
Equity |
15,485,797 |
|
9,781,216 |
|
|
|
|
|
|
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 nine months ended March 31, 2022 and
2021 |
|
|
|
|
|
Expressed in U.S. Dollars |
|
|
|
|
|
|
Three Months Ended |
Nine Months Ended |
|
|
March 31 |
March 31 |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
$ |
|
$ |
|
$ |
|
$ |
|
|
|
|
|
|
|
|
Sales |
309,585 |
|
- |
|
574,677 |
|
- |
|
|
Cost of sales |
127,308 |
|
- |
|
280,845 |
|
- |
|
|
Gross profit |
182,277 |
|
- |
|
293,832 |
|
- |
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Research and development and
patents |
1,753,545 |
|
1,772,593 |
|
5,781,867 |
|
3,621,697 |
|
|
General and
administrative |
1,915,017 |
|
1,333,725 |
|
5,124,670 |
|
2,918,067 |
|
|
Amortization and
depreciation |
53,340 |
|
27,421 |
|
131,669 |
|
92,218 |
|
|
Total operating expenses |
3,721,902 |
|
3,133,739 |
|
11,038,206 |
|
6,631,982 |
|
|
|
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
|
Interest and other
income |
30,964 |
|
3,797 |
|
62,389 |
|
11,192 |
|
|
Finance expense |
- |
|
- |
|
- |
|
(360,350 |
) |
|
Unrealized gain on derivative
warrants liability |
- |
|
- |
|
- |
|
242,628 |
|
|
Foreign exchange gain
(loss) |
32,996 |
|
28,467 |
|
(48,109 |
) |
(205,824 |
) |
|
Net loss for the period |
(3,475,665 |
) |
(3,101,475 |
) |
(10,730,094 |
) |
(6,944,336 |
) |
|
|
|
|
|
|
|
Other Comprehensive Loss |
|
|
|
|
|
Foreign currency translation
gain |
- |
|
- |
|
- |
|
430,443 |
|
|
Total comprehensive loss for the
period |
(3,475,665 |
) |
(3,101,475 |
) |
(10,730,094 |
) |
(6,513,893 |
) |
|
|
|
|
|
|
|
Net loss per share for the
period |
|
|
|
|
|
Basic and
diluted |
(0.25 |
) |
(0.41 |
) |
(0.81 |
) |
(1.11 |
) |
|
Weighted average outstanding common
shares |
|
|
|
|
|
Basic and
diluted |
14,151,544 |
|
7,549,040 |
|
13,326,754 |
|
6,277,824 |
|
|
|
|
|
|
|
|
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, 2022 and
2021 |
|
|
|
Expressed in U.S. Dollars |
|
|
|
|
2022 |
|
2021 |
|
|
|
|
|
|
Cash provided by (used in): |
$ |
|
$ |
|
|
|
|
|
|
Operating Activities |
|
|
|
Net loss for the period |
(10,730,094 |
) |
(6,944,336 |
) |
|
Items not requiring cash: |
|
|
|
Amortization and
depreciation |
131,669 |
|
92,218 |
|
|
Share-based
compensation |
521,006 |
|
389,343 |
|
|
Amortization of right-of-use
assets |
226,061 |
|
88,620 |
|
|
Loss on disposal of
assets |
11,355 |
|
- |
|
|
Interest income received on
short-term investments |
46 |
|
159 |
|
|
Unrealized gain on derivative
warrants liability |
- |
|
(242,628 |
) |
|
Unrealized foreign exchange
loss |
312 |
|
(571 |
) |
|
Payments on lease obligations |
(232,633 |
) |
(66,537 |
) |
|
Finance expense |
- |
|
360,350 |
|
|
Changes in non-cash working capital: |
|
|
|
Inventories |
(933,260 |
) |
- |
|
|
Prepaids and other
assets |
(323,653 |
) |
(1,192,936 |
) |
|
Other non-current
assets |
6,580 |
|
(14,161 |
) |
|
Accounts receivable |
(22,535 |
) |
(18,183 |
) |
|
Accounts payable and accrued
liabilities |
(195,125 |
) |
(235,892 |
) |
|
Deferred revenue |
3,760 |
|
- |
|
|
Total cash used in operating
activities |
(11,536,511 |
) |
(7,784,554 |
) |
|
|
|
|
|
Investing Activities |
|
|
|
Cash acquired from acqusition of
BayMedica |
91,566 |
|
- |
|
|
Purchase of property and
equipment |
(39,108 |
) |
- |
|
|
Total cash provided by investing
activities |
52,458 |
|
- |
|
|
|
|
|
|
Financing Activities |
|
|
|
Shares issued for
cash |
12,000,001 |
|
12,472,500 |
|
|
Share issuance costs |
(1,294,247 |
) |
(1,534,602 |
) |
|
Repayment of debt |
(261,514 |
) |
- |
|
|
Settlement of debt upon acquisition
of subsidiary |
(425,000 |
) |
- |
|
|
Total cash provided by financing
activities |
10,019,240 |
|
10,937,898 |
|
|
Effects of foreign exchange on cash and cash
equivalents |
- |
|
494,960 |
|
|
Increase (decrease) in cash during the
period |
(1,464,813 |
) |
3,648,304 |
|
|
Cash and cash equivalents beginning of the
period |
7,363,126 |
|
5,805,809 |
|
|
Cash and cash equivalents end of the
period |
5,898,313 |
|
9,454,113 |
|
|
|
|
|
|
About InMed: InMed
Pharmaceuticals is a global leader in the research, development,
manufacturing and commercialization of rare cannabinoids. Together
with its subsidiary BayMedica, LLC, the Company has unparalleled
cannabinoid manufacturing capabilities to serve a spectrum of
consumer markets, including pharmaceutical and health and wellness.
InMed is also a clinical-stage company developing a pipeline of
rare cannabinoid therapeutics and dedicated to delivering new
treatment alternatives to patients that may benefit from
cannabinoid-based pharmaceutical drugs. For more information,
visit www.inmedpharma.com and www.baymedica.com.
Investor Contact: Colin ClancySenior Director,
Investor RelationsT: +1.604.416.0999E: cclancy@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: expanding rare cannabinoid portfolio;
strengthening IP with publication of a patent application for novel
cannabinoid analogs; commencing sales of the rare cannabinoids CBDV
and CBT as raw ingredients for the health and wellness industry;
commercial scale production of delta-9 dominant
tetrahydrocannabivarin (“THCV”) in anticipation of commencing B2B
sales; CBDV and THCV being highly anticipated; several additional
high-value rare cannabinoids in various stages of development and
commercial manufacturing scale-up; establishing a reliable supply
of rare cannabinoids at commercial scale for manufacturers and
consumer brands to deliver improved and differentiated products;
evaluating potential partners and co-development collaborations for
novel product development; supplying the rare cannabinoid THCV for
incorporation into Trokie’s proprietary product formulation that
will then be evaluated in Radicle Science’s “Radicle Energy” study
on energy, focus/attention, appetite and weight/body mass index
(“BMI”); enrollment and patient treatment of the Company’s Phase 2
clinical trial, 755-201-EB, of INM-755 (cannabinol) cream in the
treatment of EB; the 755-201-EB study including 13 sites across 8
countries with enrollment and patient treatment being completed
during the calendar year 2022; the 755-201-EB study enrolling up to
20 patients to study the safety and preliminary efficacy of INM-755
(cannabinol) cream; having Company recently completed a
pre-Investigational New Drug (“pIND”) application discussion with
the U.S. Food and Drug Administration (“FDA”) regarding
manufacturing, preclinical studies and early clinical development
plans for INM-088, a cannabinol (“CBN”) formulation in development
for glaucoma; gaining alignment with FDA on the design of the
initial Phase 1-2 clinical trial to gather preliminary data on the
safety and efficacy of INM-088 treatment; the FDA providing
guidance for the development program based on a summary of the
available preclinical data, clinical safety data for CBN from the
INM-755 program, study designs for additional IND-enabling
preclinical studies, and Chemistry Manufacturing and Controls
(“CMC”) information; expecting to file regulatory applications in
the first half of the calendar year 2023, to initiate a human
clinical trial; the publication of a patent application in North
America for several cannabinoid analogs covering broad claims
directed to their molecular structure, uses and methods of
manufacturing; technology that allows for the creation of libraries
of new chemical entities (“NCEs”), which the Company will screen in
several in vitro and in vivo models to select therapeutic
candidates for advancement; the initiation of a research
collaboration agreement with the Department of Biotechnological and
Applied Clinical Sciences, University of L’Aquila (Italy) in the
laboratory of Dr. Mauro Maccarrone to screen the Company’s novel
cannabinoid analogs to investigate pharmacological properties and
potential therapeutic uses; the Company anticipates revenue growth
in the coming quarters with the commercialization of CBDV and THCV
as well as additional planned launches; being a global leader in
the research, development, manufacturing and development of rare
cannabinoids; and delivering new treatment alternatives to patients
that may benefit from cannabinoid-based pharmaceutical drugs.
With respect to the forward-looking information
contained in this news release, InMed has made numerous
assumptions. 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. A complete discussion
of the risks and uncertainties facing InMed’s stand-alone business
is disclosed in InMed’s Annual Report on Form 10-K and other
filings with the Securities and Exchange Commission on
www.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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