InMed Pharmaceuticals Inc. (“InMed” or the
“Company”) (Nasdaq: INM), a leader in the pharmaceutical research,
development and manufacturing of rare cannabinoids and cannabinoid
analogs, today reported financial results for the first quarter of
fiscal year 2023, ended September 30, 2022.
The Company’s condensed financial statements and
related MD&A for the first quarter of fiscal year 2023, ended
September 30, 2022 will be available at www.inmedpharma.com and at
www.sedar.com.
Eric A. Adams, InMed CEO, states, “In the first
quarter of our new fiscal year, we continue to strengthen our
pharmaceutical pipeline in dermatology, ocular and
neurodegenerative diseases, as well as continue to screen our
library of proprietary analogs for additional therapeutic
candidates. Throughout the remainder of the year and into calendar
year 2023, we have many milestones to look forward to in our
clinical and preclinical programs, including the completion of our
Phase 2 clinical trial in epidermolysis bullosa as well as
advancing our glaucoma program towards human trials.”
Business Update
Pharmaceutical Development
Programs
INM-755 for the treatment of
Epidermolysis Bullosa (“EB”)Enrollment and patient
treatment in the Company’s Phase 2 clinical trial, 755-201-EB, has
continued through the first quarter and is expected to complete
during calendar year 2022.
InMed’s Phase 2 clinical trial now has all 11
clinical trial sites fully activated to screen and enroll patients.
The clinical trial is taking place in seven countries (Austria,
Germany, Greece, France, Italy, Israel and Spain).
InMed is evaluating the safety of INM-755
(cannabinol) cream and its preliminary efficacy in treating
symptoms and wound healing in persons with EB 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
glaucoma
The Company continues to do necessary
preclinical work including toxicology and GLP studies in advance of
human clinical trials.
Earlier in the year, the Company 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 CBN formulation in development for glaucoma.
The Company 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.
InMed data suggest CBN is the cannabinoid of
choice for neuroprotection and lowering intraocular pressure in
glaucoma and potentially other ocular diseases.
New cannabinoid analogs for the
treatment of neurodegenerative diseases
The Company continues to advance discovery work
to identify an appropriate compound for a preclinical development
program for treating neurodegenerative disorders such as
Alzheimer’s disease, Parkinson’s disease and Huntington’s
disease.
The Company remains focused on the generation of
proprietary cannabinoid analogs to support its pharmaceutical drug
development programs. As these novel cannabinoid analogs are
patentable, they protect the long-term research investment and
commercial opportunities.
BayMedica commercial
activities
BayMedica commercial activities remain steady as
the Company continues to work through existing inventories as a B2B
supplier of rare cannabinoids to the health and wellness market.
The Company continues to explore potential opportunities for
structured supply agreements, commercial collaborations and review
other strategic alternatives for the commercial aspect of its
business.
Financial and Operational
Highlights:
For the three months ended September 30, 2022,
the Company recorded a net loss of $3.5 million, or $4.06 per
share, compared with a net loss of $3.0 million, or $6.17 per
share, for the three months ended September 30, 2021.
Research and development expenses were $1.4
million for the three months ended September 30, 2022, compared
with $1.5 million for the three months ended September 30, 2021.
The decrease in research and development and patents expenses was
primarily due to decreased activities related to the INM-755 Phase
2 clinical trials which were offset by the inclusion of BayMedica
operating results following the acquisition date.
The Company incurred general and administrative
expenses of $1.6 million for the three months ended September 30,
2022, compared with $1.4 million for the three months ended
September 30, 2021. The increase is due to the inclusion of
BayMedica operating results following the acquisition date.
The Company realized sales of $0.3 million in
our BayMedica segment for the for the three months ended September
30, 2022, the result of the manufacturing and sale of bulk rare
cannabinoid products following the acquisition of BayMedica in
October 2021. As the period ended September 30, 2021 predated the
acquisition of BayMedica, there are no comparable revenues in
2021.
At September 30, 2022, the Company’s cash, cash
equivalents and short-term investments were $9.4 million, which
compares to $6.2 million at June 30, 2022. On September 13, 2022,
the Company closed a $6.0 million private placement with two
healthcare-focused institutional investors. Based on the current
forecast, which is subject to potential revisions in the future,
the Company’s cash reserves are estimated to last into the second
half of fiscal 2023, and possibly into the first quarter of fiscal
2024 (being the third calendar quarter of 2023), depending on the
level and timing of realizing revenues from the sale of BayMedica
inventory as well as the level and timing of the Company’s
operating expenses.
As a result of the decision to de-emphasize the
commercial business due to lower demand outlook and downward
pricing pressure, the Company incurred a write-down of inventories
to net realizable value of $0.6 million during the period ended
September 30, 2022.
At September 30, 2022, the Company’s total
issued and outstanding shares were 908,766, or 1,510,011 including
all outstanding pre-funded warrants which are considered common
share equivalents. During the three months ending September 30,
2021, including the pre-funded warrants, the weighted average
number of common shares was 865,619, which is used for the
calculation of loss per share for the interim period.
Table 1: Condensed Consolidated Interim
Balance Sheets:
InMed Pharmaceuticals Inc. |
|
|
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
(unaudited) |
|
As at September 30, 2022 and June 30, 2022 |
|
|
Expressed in U.S. Dollars |
|
|
|
September 30, |
|
June 30, |
|
|
2022 |
|
2022 |
|
|
|
|
ASSETS |
$ |
|
$ |
|
Current |
|
|
Cash and cash equivalents |
9,350,427 |
|
6,176,866 |
|
Short-term investments |
42,125 |
|
44,804 |
|
Accounts receivable |
15,169 |
|
88,027 |
|
Inventories |
1,778,523 |
|
2,490,854 |
|
Prepaids and other assets |
356,665 |
|
797,225 |
|
Total current assets |
11,542,909 |
|
9,597,776 |
|
|
|
|
Non-Current |
|
|
Property, equipment and ROU assets,
net |
802,369 |
|
904,252 |
|
Intangible assets, net |
2,067,922 |
|
2,108,915 |
|
Other assets |
171,130 |
|
176,637 |
|
Total Assets |
14,584,330 |
|
12,787,580 |
|
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
Current |
|
|
Accounts payable and accrued
liabilities |
2,362,190 |
|
2,415,265 |
|
Current portion of lease obligations |
404,163 |
|
404,276 |
|
Deferred revenue |
15,700 |
|
- |
|
Acquisition consideration payable |
500,000 |
|
500,000 |
|
Total current liabilities |
3,282,053 |
|
3,319,541 |
|
|
|
|
Non-current |
|
|
Lease obligations |
294,337 |
|
389,498 |
|
Total Liabilities |
3,576,390 |
|
3,709,039 |
|
|
|
|
Shareholders' Equity |
|
|
Common shares, no par value, unlimited authorized
shares: |
|
|
908,766 (June 30, 2022 - 650,667) issued and
outstanding |
72,671,392 |
|
70,718,461 |
|
Additional paid-in capital |
35,170,766 |
|
31,684,098 |
|
Accumulated deficit |
(96,962,787 |
) |
(93,452,587 |
) |
Accumulated other comprehensive income |
128,569 |
|
128,569 |
|
Total Shareholders' Equity |
11,007,940 |
|
9,078,541 |
|
Total Liabilities and Shareholders'
Equity |
14,584,330 |
|
12,787,580 |
|
|
|
|
Table 2: Condensed Consolidated Interim
Statements of Operations and Comprehensive Loss:
|
|
|
InMed Pharmaceuticals Inc. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (unaudited) |
For the three months ended September 30, 2022 and 2021 |
|
|
Expressed in U.S. Dollars |
|
|
|
Three Months Ended |
|
September 30 |
|
2022 |
|
2021 |
|
|
$ |
|
$ |
|
|
|
|
Sales |
320,788 |
|
- |
|
Cost of sales |
235,034 |
|
- |
|
Inventory write-down |
576,772 |
|
- |
|
Gross loss |
(491,018 |
) |
- |
|
|
|
|
Operating Expenses |
|
|
Research and development and patents |
1,378,653 |
|
1,491,252 |
|
General and administrative |
1,560,477 |
|
1,372,867 |
|
Amortization and depreciation |
49,048 |
|
28,532 |
|
Total operating expenses |
2,988,178 |
|
2,892,651 |
|
|
|
|
Other Income (Expense) |
|
|
Interest and other income |
72,587 |
|
5,148 |
|
Foreign exchange loss |
(96,791 |
) |
(84,112 |
) |
Loss before income taxes |
(3,503,400 |
) |
(2,971,615 |
) |
|
|
|
Tax expense |
(6,800 |
) |
- |
|
Net loss for the period |
(3,510,200 |
) |
(2,971,615 |
) |
|
|
|
Net loss per share for the
period |
|
|
Basic and
diluted |
(4.06 |
) |
(6.17 |
) |
Weighted average outstanding common
shares |
|
|
Basic and
diluted |
865,619 |
|
481,902 |
|
|
|
|
Table 3: Condensed Consolidated Interim
Statements of Cash Flows:
|
|
|
InMed Pharmaceuticals Inc. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(unaudited) |
|
For the three months ended September 30, 2022 and 2021 |
|
|
Expressed in U.S. Dollars |
|
|
|
2022 |
|
2021 |
|
|
|
|
Cash provided by (used in): |
$ |
|
$ |
|
|
|
|
Operating Activities |
|
|
Net loss for the period |
(3,510,200 |
) |
(2,971,615 |
) |
Items not requiring cash: |
|
|
Amortization and depreciation |
49,048 |
|
28,532 |
|
Share-based compensation |
116,680 |
|
111,142 |
|
Amortization of right-of-use assets |
99,460 |
|
25,906 |
|
Interest income received on short-term
investments |
(120 |
) |
(23 |
) |
Unrealized foreign exchange loss |
2,796 |
|
1,262 |
|
Inventory write-down |
576,772 |
|
- |
|
Payments on lease obligations |
(100,903 |
) |
(17,411 |
) |
Changes in non-cash working capital: |
|
|
Inventories |
135,559 |
|
- |
|
Prepaids and other assets |
440,560 |
|
634,410 |
|
Other non-current assets |
5,507 |
|
6,030 |
|
Accounts receivable |
72,858 |
|
(2,923 |
) |
Accounts payable and accrued
liabilities |
(159,260 |
) |
(469,227 |
) |
Deferred revenue |
15,700 |
|
- |
|
Total cash used in operating
activities |
(2,255,543 |
) |
(2,653,917 |
) |
|
|
|
Investing Activities |
|
|
Short-term loan |
- |
|
(250,000 |
) |
Total cash used in investing
activities |
- |
|
(250,000 |
) |
|
|
|
Financing Activities |
|
|
Shares issued for cash |
6,000,365 |
|
11,999,825 |
|
Share issuance costs |
(571,261 |
) |
(1,115,129 |
) |
Total cash provided by financing
activities |
5,429,104 |
|
10,884,696 |
|
Increase (decrease) in cash during the
period |
3,173,561 |
|
7,980,779 |
|
Cash and cash equivalents beginning of the
period |
6,176,866 |
|
7,363,126 |
|
Cash and cash equivalents end of the
period |
9,350,427 |
|
15,343,905 |
|
|
|
|
About InMed: InMed
Pharmaceuticals is a global leader in the pharmaceutical research,
development and manufacturing of rare cannabinoids and cannabinoid
analogs, including clinical and preclinical programs targeting
the treatment of diseases with high unmet medical needs. We
also have significant know-how in developing proprietary
manufacturing approaches to produce cannabinoids for various market
sectors. For more information, visit www.inmedpharma.com and
www.baymedica.com.
Investor Contact: Colin ClancyVice President,
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: continuing to strengthen the
pharmaceutical pipeline in dermatology, ocular and
neurodegenerative diseases; continuing to screen a library of
proprietary analogs for additional therapeutic candidates;
expecting many milestones in the clinical and preclinical programs;
evaluating the safety of INM-755 (cannabinol) cream and its
preliminary efficacy in treating symptoms; the completion of Phase
2 clinical trial in epidermolysis bullosa during calendar year
2022; advancing the glaucoma program towards human trials; CBN
being the cannabinoid of choice for neuroprotection and lowering
intraocular pressure in glaucoma and potentially other ocular
diseases; advancing discovery work to identify an appropriate
compound for a preclinical development program for treating
neurodegenerative disorders such as Alzheimer’s disease,
Parkinson’s disease and Huntington’s disease; the generation of
proprietary cannabinoid analogs to support the Company’s
pharmaceutical drug development programs; BayMedica exploring
potential opportunities for structured supply agreements,
commercial collaborations and review other strategic alternatives
for the commercial aspect of its business; the Company’s current
cash reserves are estimated to last into the second half of fiscal
2023, and possibly into the first quarter of fiscal 2024.
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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