InMed Pharmaceuticals Reports Third Quarter Fiscal 2021 Financial Results
May 13 2021 - 7:30AM
InMed Pharmaceuticals Inc. (“InMed” or the
“Company”) (NASDAQ:INM), a clinical-stage company developing
pharmaceutical-based drug candidates and leading the way in the
clinical development of cannabinol (“CBN”), today reported
financial results for the third quarter of fiscal year 2021
(“3Q21”) which ended March 31, 2021.
The Company will be hosting a conference call to
present the 3Q21 results, as follows:
Conference Call &
Webcast*:Thursday, May 13, 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:
3186833Webcast: https://edge.media-server.com/mmc/p/ajuejmko(*Webcast
replay available for 90 days)
The Company’s 10-Q including financial
statements and related MD&A for the third quarter ending March
31, 2021 are available at www.inmedpharma.com, www.sedar.com and at
www.sec.gov.
“In the third quarter of fiscal 2021,
significant progress was made in InMed’s INM-755 therapeutic
program and IntegraSynTM manufacturing approach, resulting in the
announcement of important milestones shortly after the quarter’s
end,” said InMed President and Chief Executive Officer, Eric A.
Adams. “The submission of Clinical Trial Applications in several
countries, seeking permission to begin a Phase 2 safety and
efficacy clinical trial in Epidermolysis Bullosa patients and the
achievement of a commercially viable yield using the IntegraSynTM
manufacturing approach bring us one step closer to delivering new
therapeutic alternatives to patients who may benefit from
cannabinoid-based pharmaceutical drugs. In addition to our R&D
advances this past quarter, we continue to explore business
development opportunities as a potential avenue to build the
Company and accelerate our programs.”
Research & Development
Update:
INM-755 for the Treatment of
Epidermolysis Bullosa (“EB”):
- On April 28,
2021, InMed announced that it had filed Clinical Trial Applications
(“CTAs”) in Austria, Israel and Serbia as
part of a Phase 2 clinical trial of INM-755 (cannabinol) cream in
Epidermolysis Bullosa (“EB”). Since then, additional CTAs for
755-201-EB (the ‘201 study) have been submitted to National
Competent Authorities (“NCAs”) and Ethics Committees (“ECs”)
in France and Germany. We also expect to file CTAs in
Greece and Italy in the coming weeks. Responses from the
NCAs and ECs are expected throughout July and August 2021;
timing will vary slightly by country due to differences in local
procedures. The ‘201 study is designed to enroll up to 20 patients,
conservatively within 10-12 months, and will take place at 10
pre-qualified clinical sites in the above-mentioned countries. 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 healing
wounds over a 28-day period. The study will use a within-patient,
double-blind design whereby matched index areas will be randomized
to INM-755 (cannabinol) cream or vehicle cream as a control.
IntegraSynTM:
- On April 26,
2021, InMed announced that its IntegraSynTM cannabinoid
manufacturing approach had achieved a level of 2g/L cannabinoid
yield, a milestone that signals commercial viability and supports
advancement to large-scale production in the coming months. Having
achieved a 2g/L yield level, InMed will now focus on manufacturing
scale-up to larger batch sizes while continuing process and enzyme
optimization, targeting increased cannabinoid yield and further
reducing the overall cost of goods. In parallel, the Company
continues to prepare the manufacturing process to be Good
Manufacturing Practice (GMP)-ready for pharmaceutical quality
production. The next stage of large-scale production is to produce
a batch with a target output of one kilogram of the selected
cannabinoid in 2H2021 via a GMP-ready process.
Financing Activity
and Results of Operations (expressed in US Dollars):
- On February 5,
2021, the Company announced that it had entered into definitive
agreements with certain institutional investors to raise aggregate
gross proceeds of approximately $4.5 million and on February 16,
2021, the Company announced that it had closed the private
placement. Under the terms of the private placement, an aggregate
of 1,050,000 units were purchased, each unit comprised of one
common share and 0.66 of a warrant to purchase one common share, at
a placement price of $4.25 per unit. The warrants have an exercise
price of $4.85, are exercisable six months following issuance, and
have a term of five and one half years following issuance. After
the placement agent fees and estimated offering expenses payable by
the Company, the Company received net proceeds of approximately
$4.0 million.
- 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 will continue to be listed and
tradable on the Nasdaq under “INM”. The Company believes that the
trading volume of its shares on the TSX no longer justified the
expense and administrative efforts associated with maintaining this
dual listing. InMed’s common shares were delisted from the TSX at
the close of trading on May 7, 2021.
- For the three
and nine months ended March 31, 2021, the Company recorded a net
loss of $3.1 million and $6.9 million, or $0.41 and $1.11 per
share, compared with a net loss of $2.0 million and $7.3 million,
or $0.39 and $1.40 per share, for the three and nine months ended
March 31, 2020.
- Research and
development expenses were $1.8 million for 3Q21, compared with $1.3
million for the three months ended March 31, 2020. The increase in
research and development and patents expenses was primarily due to
increased spend on the INM-755 program, including the preparation
during this period for the planned commencement of a Phase 2 trial.
For the nine months ended March 31, 2021, research and development
expenses totaled $3.6 million, compared with $4.8 million for the
same period in fiscal 2020. The reduction in research and
development and patents expenses was primarily due to decreased
spending on the integrated cannabinoid manufacturing program and
the INM-755 program, including decreased purchases of the active
pharmaceutical ingredients used in INM-755 clinical trials. In
addition, share-based payments were lower for the nine months ended
March 31, 2021.
- The Company
incurred general and administrative expenses of $1.3 million for
3Q21, compared with $0.9 million for the three months ended March
31, 2020. For the nine months ended March 31, 2021, general and
administrative expenses totaled $2.9 million, compared with $2.7
million for the same period in fiscal 2020. The increase results
from a combination of changes including substantially higher
insurance fees, offset by lower share-based payments and lower
legal costs associated with negotiating contracts and other matters
in the current period and certain current year legal costs being
capitalized to equity.
- The Company
also incurred non-cash, share-based payments in connection with the
grant of stock options, of $0.2 million for each of 3Q21 and the
three months ended March 31, 2020. For the nine months ended March
31, 2021, non-cash, share-based payments totaled $0.4 million
compared with $0.8 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 March 31,
2021, the Company's cash, cash equivalents and short-term
investments were $9.5 million, which compares to $5.8 million at
June 30, 2020. The increase in cash, cash equivalents and
short-term investments during the nine months to March 31, 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 March 31,
2021, the Company's total issued and outstanding shares were
8,050,707. Including outstanding stock options and warrants, as at
March 31, 2021, the Company had 11,415,228 shares on a fully
diluted basis. During the three and nine months ending March 31,
2021, the weighted average number of common shares was 7,549,040
and 6,277,824, 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 March 31, 2021 and June
30, 2020 |
|
|
Expressed in U.S. Dollars |
|
|
|
March 31, |
|
June 30, |
|
|
2021 |
|
2020 |
|
|
|
|
ASSETS |
$ |
|
$ |
|
Current |
|
|
Cash and cash equivalents |
9,454,113 |
|
5,805,809 |
|
Short-term investments |
45,765 |
|
42,384 |
|
Accounts receivable |
70,300 |
|
45,344 |
|
Prepaids and other assets |
1,326,526 |
|
418,920 |
|
Total current assets |
10,896,704 |
|
6,312,457 |
|
|
|
|
Non-Current |
|
|
Property and equipment, net |
347,892 |
|
403,485 |
|
Intangible assets, net |
1,085,748 |
|
1,086,655 |
|
Other assets |
14,655 |
|
- |
|
Total Assets |
12,344,999 |
|
7,802,597 |
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' EQUITY |
|
|
Current |
|
|
Accounts payables and accrued liabilities |
1,635,477 |
|
1,607,303 |
|
Current portion of lease obligations |
78,818 |
|
68,965 |
|
Total current liabilities |
1,714,295 |
|
1,676,268 |
|
|
|
|
Non-current |
|
|
Lease obligations |
216,234 |
|
248,011 |
|
Total Liabilities |
1,930,529 |
|
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 |
21,292,201 |
|
17,764,333 |
|
Accumulated deficit |
(71,593,717 |
) |
(64,649,381 |
) |
Accumulated other comprehensive income (loss) |
128,569 |
|
(301,874 |
) |
Total Shareholders' Equity |
10,414,470 |
|
5,878,318 |
|
Total Liabilities and Shareholders'
Equity |
12,344,999 |
|
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 nine months
ended March 31, 2021 and 2020 |
|
|
|
|
Expressed in U.S. Dollars |
|
|
|
|
|
Three Months Ended |
Nine Months Ended |
|
March 31 |
March 31 |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
Operating
Expenses |
|
|
|
|
Research and development and patents |
1,772,593 |
|
1,274,913 |
|
3,621,697 |
|
4,843,656 |
|
General and administrative |
1,333,725 |
|
902,289 |
|
2,918,067 |
|
2,661,545 |
|
Amortization and depreciation |
27,421 |
|
27,113 |
|
92,218 |
|
85,572 |
|
Total operating expenses |
3,133,739 |
|
2,204,315 |
|
6,631,982 |
|
7,590,773 |
|
|
|
|
|
|
Other Income (Loss) |
|
|
|
|
Interest income |
3,797 |
|
26,330 |
|
11,192 |
|
125,231 |
|
Finance expense |
- |
|
- |
|
(360,350 |
) |
- |
|
Unrealized gain on derivative warrants liability |
- |
|
- |
|
242,628 |
|
- |
|
Foreign exchange gain (loss) |
28,467 |
|
153,927 |
|
(205,824 |
) |
142,677 |
|
Net loss for the period |
(3,101,475 |
) |
(2,024,058 |
) |
(6,944,336 |
) |
(7,322,865 |
) |
|
|
|
|
|
Other Comprehensive Loss |
|
|
|
|
Foreign currency translation (loss) gain |
- |
|
(717,510 |
) |
430,443 |
|
(685,834 |
) |
Total comprehensive loss for the
period |
(3,101,475 |
) |
(2,741,568 |
) |
(6,513,893 |
) |
(8,008,699 |
) |
|
|
|
|
|
Net loss per
share for the year |
|
|
|
|
Basic and diluted |
(0.41 |
) |
(0.39 |
) |
(1.11 |
) |
(1.40 |
) |
Weighted
average outstanding common shares |
|
|
|
|
Basic and diluted |
7,549,040 |
|
5,220,707 |
|
6,277,824 |
|
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 nine months ended
March 31, 2021 and 2020 |
|
|
Expressed in U.S. Dollars |
|
|
|
2021 |
|
2020 |
|
|
|
|
Cash provided
by (used in): |
$ |
|
$ |
|
|
|
|
Operating
Activities |
|
|
Net loss for the period |
(6,944,336 |
) |
(7,322,865 |
) |
Items not requiring cash: |
|
|
Amortization and depreciation |
92,218 |
|
85,572 |
|
Share-based compensation |
389,343 |
|
838,304 |
|
Non-cash lease expense |
88,620 |
|
63,130 |
|
Loss on disposal of assets |
- |
|
2,331 |
|
Received interest income on short-term investments |
159 |
|
80,819 |
|
Unrealized gain on derivative warrants liability |
(242,628 |
) |
- |
|
Unrealized gain on foreign exchange |
(571 |
) |
- |
|
Payments on lease
obligations |
(66,537 |
) |
(48,865 |
) |
Finance expense |
360,350 |
|
- |
|
Changes in non-cash working
capital: |
|
- |
|
Prepaids and other assets |
(1,192,936 |
) |
72,428 |
|
Other non-current assets |
(14,161 |
) |
- |
|
Accounts receivable |
(18,183 |
) |
29,704 |
|
Accounts payable and accrued liabilities |
(235,892 |
) |
223,369 |
|
Total cash used in operating
activities |
(7,784,554 |
) |
(5,976,073 |
) |
|
|
|
Investing
Activities |
|
|
Maturity of short-term investments |
- |
|
3,876,269 |
|
Purchase of short-term investments |
- |
|
(43,619 |
) |
Proceeds on disposal of property and equipment |
- |
|
546 |
|
Purchase of property and equipment |
- |
|
(43,496 |
) |
Total cash provided by investing
activities |
- |
|
3,789,700 |
|
|
|
|
Financing
Activities |
|
|
Shares issued for cash |
12,472,500 |
|
- |
|
Share issuance costs |
(1,534,602 |
) |
- |
|
Total cash provided by financing
activities |
10,937,898 |
|
- |
|
Effects of
foreign exchange on cash and cash
equivalents |
494,960 |
|
(682,210 |
) |
Increase
(decrease) in cash during the period |
3,648,304 |
|
(2,868,583 |
) |
Cash and cash equivalents beginning of the
period |
5,805,809 |
|
9,837,213 |
|
Cash and cash equivalents end of the
period |
9,454,113 |
|
6,968,630 |
|
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) in diseases
with high unmet medical need. 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: |
Edison Advisors for InMed Pharmaceuticals |
Joe Green/Laine Yonker |
T: |
+1.646.653.7030/+1.646.653.7035 |
E: |
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; filing additional
clinical trial applications in selected countries and the timing
thereof; patient enrollment and the timing thereof; exploring
business development opportunities as a potential avenue to build
the Company and accelerate InMed’s programs; anticipated responses
from regulatory authorities and ethics committees and the timing
thereof; anticipated enrollment and locations of clinical sites;
commercial viability of IntegraSyn™ and advancement to large-scale
production and the timing thereof; the focus of the Company on
manufacturing scale-up of IntegraSyn™ to larger batch sizes while
continuing process and enzyme optimization; IntegraSyn™ targeting
increased cannabinoid yield and reducing overall costs; the
preparation for IntegraSyn™ to be GMP-ready; and IntegraSyn™
targeting an output of one kilogram of the selected cannabinoid in
2H2021 via a GMP-ready process.
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. Known risk factors
include, among others: regulatory filings may not be filed or
approved 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
IntegraSyn™ 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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