UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August, 2024
Commission File Number: 001-40712
Cardiol Therapeutics
Inc.
(Translation of registrant's name into English)
602-2265 Upper Middle Road East, Oakville,
Ontario, Canada L6H 0G5
(Address of principal executive offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover Form 20-F or Form 40-F.
x Form 20-F ¨
Form 40-F
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
SUBMITTED HEREWITH
Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
CARDIOL THERAPEUTICS INC. |
|
(Registrant) |
|
|
|
|
Date: August 12, 2024 |
By: |
/s/ Chris Waddick |
|
|
Name: |
Chris Waddick |
|
|
Title: |
Chief Financial Officer |
Exhibit 99.1
CARDIOL THERAPEUTICS
INC.
CONDENSED INTERIM
CONSOLIDATED
FINANCIAL STATEMENTS
THREE AND SIX
MONTHS ENDED
JUNE 30, 2024
(EXPRESSED IN
CANADIAN DOLLARS)
(UNAUDITED)
Cardiol Therapeutics Inc.
Condensed Interim
Consolidated Statements of Financial Position
(Expressed
in Canadian Dollars)
Unaudited
| |
As
at June 30, 2024 | | |
As at
December 31, 2023 | |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents
(note 3) | |
$ | 24,021,237 | | |
$ | 34,931,778 | |
Accounts receivable | |
| 93,651 | | |
| 142,745 | |
Other receivables | |
| 148,773 | | |
| 137,127 | |
Prepaid expenses | |
| 1,617,854 | | |
| 941,442 | |
Total current assets | |
| 25,881,515 | | |
| 36,153,092 | |
| |
| | | |
| | |
Non-current assets | |
| | | |
| | |
Property and equipment (note 4) | |
| 263,009 | | |
| 337,058 | |
Intangible assets
(note 5) | |
| 168,136 | | |
| 210,358 | |
Total assets | |
$ | 26,312,660 | | |
$ | 36,700,508 | |
| |
| | | |
| | |
EQUITY
AND LIABILITIES | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities
(note 14) | |
$ | 9,431,457 | | |
$ | 8,041,485 | |
Current portion of lease liability
(note 6) | |
| 21,719 | | |
| 15,808 | |
Derivative liability
(note 7) | |
| 1,355,732 | | |
| 238,176 | |
Total current liabilities | |
| 10,808,908 | | |
| 8,295,469 | |
| |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Lease liability
(note 6) | |
| 142,554 | | |
| 158,532 | |
Total liabilities | |
| 10,951,462 | | |
| 8,454,001 | |
| |
| | | |
| | |
Equity | |
| | | |
| | |
Share
capital (note 8) | |
| 152,349,535 | | |
| 148,519,136 | |
Warrants (note 10) | |
| - | | |
| 3,517,867 | |
Contributed surplus | |
| 21,358,970 | | |
| 18,786,306 | |
Deficit | |
| (158,347,307 | ) | |
| (142,576,802 | ) |
Total equity | |
| 15,361,198 | | |
| 28,246,507 | |
Total equity
and liabilities | |
$ | 26,312,660 | | |
$ | 36,700,508 | |
The accompanying
notes to the unaudited condensed interim consolidated financial statements are an integral part of these consolidated financial statements.
Commitments (notes 5 and 12)
Subsequent events (note 9)
Approved on behalf of the Board:
"David Elsley",
Director |
|
"Guillermo Torre-Amione",
Director |
Cardiol Therapeutics Inc.
Condensed Interim Consolidated Statements
of Loss and Comprehensive Loss
(Expressed in Canadian Dollars)
Unaudited
| |
Three
Months Ended | | |
Three
Months Ended | | |
Six
Months Ended | | |
Six
Months Ended | |
| |
June 30, | | |
June 30, | | |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses (notes 9, 13,
14) | |
| | |
| | |
| | |
| |
General and administration | |
| 5,031,702 | | |
| 2,835,264 | | |
| 10,114,254 | | |
| 6,493,704 | |
Research and development | |
| 2,709,644 | | |
| 3,479,385 | | |
| 6,032,573 | | |
| 7,607,081 | |
Loss before other income | |
| (7,741,346 | ) | |
| (6,314,649 | ) | |
| (16,146,827 | ) | |
| (14,100,785 | ) |
Interest income | |
| 307,409 | | |
| 528,697 | | |
| 684,703 | | |
| 1,074,624 | |
Gain (loss) on foreign exchange | |
| 152,017 | | |
| (828,909 | ) | |
| 780,952 | | |
| (752,117 | ) |
Change in derivative liability (note
7) | |
| 691,047 | | |
| (856,893 | ) | |
| (1,117,556 | ) | |
| (782,812 | ) |
Other income | |
| - | | |
| - | | |
| 28,223 | | |
| - | |
Net loss and
comprehensive loss for the period | |
$ | (6,590,873 | ) | |
$ | (7,471,754 | ) | |
$ | (15,770,505 | ) | |
$ | (14,561,090 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic
and diluted net loss per share (note 11) | |
$ | (0.10 | ) | |
$ | (0.12 | ) | |
$ | (0.23 | ) | |
$ | (0.23 | ) |
Weighted
average number of common shares outstanding | |
| 68,751,105 | | |
| 64,105,448 | | |
| 68,005,224 | | |
| 64,098,586 | |
The accompanying
notes to the unaudited condensed interim consolidated financial statements are an integral part of these consolidated financial statements.
Cardiol Therapeutics Inc.
Condensed Interim
Consolidated Statements of Cash Flows
(Expressed
in Canadian Dollars)
Unaudited
| |
Six Months | | |
Six Months | |
| |
Ended | | |
Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | |
Operating activities | |
| | | |
| | |
Net loss and comprehensive loss for the period | |
$ | (15,770,505 | ) | |
$ | (14,561,090 | ) |
Adjustments for: | |
| | | |
| | |
Depreciation of property and equipment | |
| 81,309 | | |
| 74,479 | |
Amortization of intangible assets | |
| 42,222 | | |
| 42,222 | |
Share-based compensation | |
| 2,707,686 | | |
| 1,093,223 | |
Change in derivative liability | |
| 1,117,556 | | |
| 782,812 | |
Unrealized foreign exchange gain on
cash | |
| (640,778 | ) | |
| (849,290 | ) |
Accretion on lease liability | |
| 13,006 | | |
| 3,011 | |
Shares for services | |
| - | | |
| 16,449 | |
Changes in non-cash working capital items: | |
| | | |
| | |
Accounts receivable | |
| 49,094 | | |
| 21,579 | |
Other receivables | |
| (11,646 | ) | |
| 153,549 | |
Prepaid expenses | |
| (676,412 | ) | |
| 87,864 | |
Accounts payable and accrued liabilities | |
| 1,389,972 | | |
| (2,165,963 | ) |
Net cash used in operating activities | |
| (11,698,496 | ) | |
| (15,301,155 | ) |
| |
| | | |
| | |
Investing activities | |
| | | |
| | |
Purchase of property and equipment | |
| (7,260 | ) | |
| (48,029 | ) |
Net cash used in investing activities | |
| (7,260 | ) | |
| (48,029 | ) |
| |
| | | |
| | |
Financing activities | |
| | | |
| | |
Proceeds from stock options exercised | |
| 177,510 | | |
| - | |
Payment of lease liability | |
| (23,073 | ) | |
| (27,688 | ) |
Net cash provided by (used in) financing activities | |
| 154,437 | | |
| (27,688 | ) |
Net change in cash and cash equivalents | |
| (11,551,319 | ) | |
| (15,376,872 | ) |
Cash and cash equivalents, beginning of period | |
| 34,931,778 | | |
| 59,469,868 | |
Impact of foreign exchange on cash and cash equivalents | |
| 640,778 | | |
| 849,290 | |
Cash and cash equivalents, end
of period | |
$ | 24,021,237 | | |
$ | 44,942,286 | |
The accompanying notes to the unaudited
condensed interim consolidated financial statements are an integral part of these consolidated financial statements.
Cardiol
Therapeutics Inc.
Condensed
Interim Consolidated Statements of Changes in Equity
(Expressed
in Canadian Dollars)
Unaudited
|
|
Share capital | | |
| | |
Contributed | | |
| | |
| |
|
|
Number |
| |
Amount | | |
Warrants | | |
surplus | | |
Deficit | | |
Total | |
Balance, December 31, 2022 | |
64,042,536 | | |
$ | 147,545,399 | | |
$ | 3,517,867 | | |
$ | 15,586,832 | | |
$ | (114,448,510 | ) | |
$ | 52,201,588 | |
Restricted share units exercised | |
80,000 | | |
| 112,800 | | |
| - | | |
| (112,800 | ) | |
| - | | |
| - | |
Shares for services | |
5,000 | | |
| 16,449 | | |
| - | | |
| - | | |
| - | | |
| 16,449 | |
Share-based compensation (note 9) | |
- | | |
| - | | |
| - | | |
| 1,093,223 | | |
| - | | |
| 1,093,223 | |
Net loss and comprehensive loss for
the period | |
- | | |
| - | | |
| - | | |
| - | | |
| (14,561,090 | ) | |
| (14,561,090 | ) |
Balance, June 30, 2023 | |
64,127,536 | | |
$ | 147,674,648 | | |
$ | 3,517,867 | | |
$ | 16,567,255 | | |
$ | (129,009,600 | ) | |
$ | 38,750,170 | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2023 | |
65,352,279 | | |
$ | 148,519,136 | | |
$ | 3,517,867 | | |
$ | 18,786,306 | | |
$ | (142,576,802 | ) | |
$ | 28,246,507 | |
Fair value of expired warrants | |
- | | |
| - | | |
| (3,517,867 | ) | |
| 3,517,867 | | |
| - | | |
| - | |
Restricted share units exercised | |
1,596,034 | | |
| 1,919,588 | | |
| - | | |
| (1,919,588 | ) | |
| - | | |
| - | |
Stock options exercised | |
175,000 | | |
| 177,510 | | |
| - | | |
| - | | |
| - | | |
| 177,510 | |
Fair value of stock options exercised | |
- | | |
| 99,263 | | |
| - | | |
| (99,263 | ) | |
| - | | |
| - | |
Share-based compensation (note 9) | |
- | | |
| - | | |
| - | | |
| 2,707,686 | | |
| - | | |
| 2,707,686 | |
Performance share units exercised | |
2,200,000 | | |
| 1,634,038 | | |
| - | | |
| (1,634,038 | ) | |
| - | | |
| - | |
Net loss and comprehensive loss for
the period | |
- | | |
| - | | |
| - | | |
| - | | |
| (15,770,505 | ) | |
| (15,770,505 | ) |
Balance, June 30, 2024 | |
69,323,313 | | |
$ | 152,349,535 | | |
$ | - | | |
$ | 21,358,970 | | |
$ | (158,347,307 | ) | |
$ | 15,361,198 | |
The accompanying
notes to the unaudited condensed interim consolidated financial statements are an integral part of these consolidated financial statements.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three and Six Months Ended June 30,
2024
(Expressed in Canadian Dollars)
Unaudited
Cardiol Therapeutics
Inc. was incorporated under the laws of the Province of Ontario on January 19, 2017. The Corporation's registered and legal office
is located at 2265 Upper Middle Rd. E., Suite 602, Oakville, Ontario, L6H 0G5, Canada.
Cardiol Therapeutics
Inc. and its subsidiary (the "Corporation" or "Cardiol") is a clinical-stage life sciences company focused on the
research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Corporation's
lead drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use
in the treatment of heart disease.
On December 20,
2018, the Corporation completed its initial public offering on the Toronto Stock Exchange (the "TSX"). As a result, the Corporation's
common shares commenced trading on that date on the TSX under the symbol "CRDL". On August 10, 2021, the Corporation's
common shares commenced trading on The Nasdaq Capital Market under the symbol "CRDL".
| 2. | Material
accounting policy information |
Statement of
compliance
The Corporation
applies International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”)
and Interpretations issued by the International Financial Reporting Interpretations Committee (“IFRIC”). These unaudited
condensed interim consolidated financial statements have been prepared in accordance with International Accounting Standard 34, Interim
Financial Reporting. Accordingly, they do not include all of the information required for full annual financial statements required by
IFRS as issued by IASB and interpretations issued by IFRIC.
The policies applied
in these unaudited condensed interim consolidated financial statements are based on IFRSs issued and outstanding as of August 12,
2024, the date the Board of Directors approved the statements. The same accounting policies and methods of computation are followed in
these unaudited condensed interim consolidated financial statements as compared with the most recent annual consolidated financial statements
as at and for the year ended December 31, 2023.
Any subsequent
changes to IFRS that are given effect in the Corporation’s annual consolidated financial statements for the year ending December 31,
2024, could result in restatement of these unaudited condensed interim consolidated financial statements.
| 3. | Cash
and cash equivalents |
Interest earned
on cash and cash equivalents for the three and six months ended June 30, 2024 amounted to $307,409 and $684,703 (three and six months
ended June 30, 2023 - $528,697 and $1,074,624).
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three and Six Months Ended June 30,
2024
(Expressed in Canadian Dollars)
Unaudited
Cost | |
Right-of-
use asset | | |
Equipment | | |
Leasehold
improvements | | |
Office
equipment | | |
Computer
equipment | | |
Total | |
Balance, December 31, 2022 | |
$ | 200,319 | | |
$ | 171,864 | | |
$ | 237,248 | | |
$ | 66,864 | | |
$ | 112,290 | | |
$ | 788,585 | |
Additions | |
| 140,919 | | |
| 47,945 | | |
| - | | |
| - | | |
| 16,367 | | |
| 205,231 | |
Balance, December 31, 2023 | |
| 341,238 | | |
| 219,809 | | |
| 237,248 | | |
$ | 66,864 | | |
$ | 128,657 | | |
$ | 993,816 | |
Additions | |
| - | | |
| - | | |
| - | | |
| - | | |
| 7,260 | | |
| 7,260 | |
Balance, June 30, 2024 | |
$ | 341,238 | | |
$ | 219,809 | | |
$ | 237,248 | | |
$ | 66,864 | | |
$ | 135,917 | | |
$ | 1,001,076 | |
Accumulated
Depreciation | |
| Right-of-
use asset | | |
| Equipment | | |
| Leasehold
improvements | | |
| Office
equipment | | |
| Computer
equipment | | |
| Total | |
Balance, December 31, 2022 | |
$ | 143,577 | | |
$ | 94,961 | | |
$ | 156,712 | | |
$ | 33,728 | | |
$ | 63,869 | | |
$ | 492,847 | |
Depreciation for the year | |
| 53,091 | | |
| 36,761 | | |
| 50,840 | | |
| 6,627 | | |
| 16,592 | | |
| 163,911 | |
Balance, December 31, 2023 | |
$ | 196,668 | | |
$ | 131,722 | | |
$ | 207,552 | | |
$ | 40,355 | | |
$ | 80,461 | | |
$ | 656,758 | |
Depreciation for the period | |
| 31,992 | | |
| 13,213 | | |
| 25,420 | | |
| 2,651 | | |
| 8,033 | | |
| 81,309 | |
Balance, June 30, 2024 | |
$ | 228,660 | | |
$ | 144,935 | | |
$ | 232,972 | | |
$ | 43,006 | | |
$ | 88,494 | | |
$ | 738,067 | |
Carrying
value | |
| Right-of-
use asset | | |
| Equipment | | |
| Leasehold
improvements | | |
| Office
equipment | | |
| Computer
equipment | | |
| Total | |
Balance, December 31, 2023 | |
$ | 144,570 | | |
$ | 88,087 | | |
$ | 29,696 | | |
$ | 26,509 | | |
$ | 48,196 | | |
$ | 337,058 | |
Balance, June 30, 2024 | |
$ | 112,578 | | |
$ | 74,874 | | |
$ | 4,276 | | |
$ | 23,858 | | |
$ | 47,423 | | |
$ | 263,009 | |
Cost | |
Exclusive global
license agreement | |
Balance, December 31, 2022, December 31,
2023, and June 30, 2024 | |
$ | 767,228 | |
Accumulated Amortization | |
Exclusive global
license agreement | |
Balance, December 31, 2022 | |
$ | 472,426 | |
Amortization for the year | |
| 84,444 | |
Balance, December 31, 2023 | |
$ | 556,870 | |
Amortization for the period | |
| 42,222 | |
Balance, June 30, 2024 | |
$ | 599,092 | |
Carrying Value | |
Exclusive global
license agreement | |
Balance, December 31, 2023 | |
$ | 210,358 | |
Balance, June 30, 2024 | |
$ | 168,136 | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three and Six Months Ended June 30,
2024
(Expressed in Canadian Dollars)
Unaudited
| 5. | Intangible
assets (continued) |
Exclusive global agreement ("Meros
License Agreement")
In 2017, the Corporation
was granted by Meros Polymers Inc. (“Meros”) the sole, exclusive, irrevocable license to patented nanotechnologies for use
with any drugs to diagnose, or treat, cardiovascular disease, cardiopulmonary disease, and cardiac arrhythmias. Meros is focused on the
advancement of nanotechnologies developed at the University of Alberta.
Under the Meros
License Agreement, Cardiol agreed to certain milestones and milestone payments, including the following: (i) payment of $100,000
upon enrolling the first patient in a Phase IIB clinical trial designed to investigate the safety and indications of efficacy of one
of the licensed technologies; (ii) payment of $500,000 upon enrolling the first patient in a Pivotal Phase III clinical trial designed
to investigate the safety and efficacy of one of the licensed technologies; (iii) $1,000,000 upon receiving regulatory approval
from the FDA for any therapeutic and/or prophylactic treatment incorporating the licensed technologies. No milestone payments have been
earned or made to date. Cardiol also agreed to pay Meros the following royalties:
(a) 5% of
worldwide proceeds of net sales of the licensed technologies containing cannabinoids, excluding non-royalty sub-license income in (b) below,
that Cardiol receives from human and animal disease indications and derivatives as outlined in the Meros License Agreement;
(b) 7% of
any non-royalty sub-license income that Cardiol receives from human and animal disease indications and derivatives for licensed technologies
containing cannabinoids as outlined in the Meros License Agreement;
(c) 3.7%
of worldwide proceeds of net sales that Cardiol receives from the licensed technology in relation to human and animal cardiovascular
and/or cardiopulmonary disease, heart failure, and/or cardiac arrhythmia diagnosis and/or treatments using the drugs, excluding cannabinoids
included in (a) above, outlined in the Meros License Agreement; and
(d) 5% of
any non-royalty sub-license income that Cardiol receives in relation to any human and animal heart disease, heart failure and/or arrhythmias
indications, excluding cannabinoids included in (b) above, as outlined in the Meros License Agreement.
In addition, as
part of the consideration under the Meros License Agreement, Cardiol (i) issued to Meros 1,020,000 common shares; and (ii) issued
to Meros 1,020,000 special warrants convertible automatically into common shares for no additional consideration upon the first patient
being enrolled in a Phase 1 clinical trial using the licensed technologies as described in the Meros License Agreement. As of June 30,
2024, and the date of these financial statements, this condition has not been met.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
| |
Carrying
Value | |
Balance, December 31, 2022 | |
$ | 72,871 | |
Additions (i) | |
| 140,919 | |
Repayments | |
| (55,376 | ) |
Accretion | |
| 15,926 | |
Balance, December 31, 2023 | |
$ | 174,340 | |
Repayments | |
| (23,073 | ) |
Accretion | |
| 13,006 | |
Balance, June 30, 2024 | |
$ | 164,273 | |
Current portion | |
| 21,719 | |
Long-term portion | |
$ | 142,554 | |
(i) When measuring the lease liability for
the property lease that was classified as an operating lease, the Corporation discounted the lease payments using its incremental borrowing
rate. The original property lease expires on May 31, 2024, and the lease payments were discounted with a 9% interest rate. During
the year ended December 31, 2023, the property lease was extended to October 30, 2028. The lease liability was revalued as
of the extension date with lease payments discounted with a 15% interest rate.
On November 5, 2021, the Corporation issued
8,175,000 warrants as part of a unit financing. Each warrant is exercisable into one common share at the price of USD$3.75 per share
for a period of three years from closing. The original estimated fair value of $11,577,426 was assigned to the 8,175,000 warrants issued
by using a fair value market technique incorporating the Black-Scholes option pricing model, with the following assumptions: a risk-free
interest rate of 1.01%; an expected volatility factor of 81%; an expected dividend yield of 0%; and an expected life of 3 years. The
only significant unobservable input is the volatility, which could cause an increase or decrease in fair value. The warrants have been
classified as a derivative liability on the statement of financial position and are re-valued at each reporting date, as the warrants
were issued in a currency other than the Corporation's functional currency. As at June 30, 2024, the fair value of the derivative
liability was $1,355,732 (December 31, 2023 - $238,176), resulting in an (increase)/decrease in the value of the derivative liability
for the three and six months ended June 30, 2024 of $691,047 and $(1,117,556) (three and six months ended June 30, 2023 - $(856,893)
and $(782,812)).
Significant assumptions used in determining the
fair value of the derivative warrant liabilities are as follows:
| |
Six Months
Ended | | |
Six Months
Ended | |
| |
June 30,
2024 | | |
June 30,
2023 | |
Share price | |
USD$ |
2.02 | | |
USD$ |
0.89 | |
Exercise price | |
USD$ |
3.75 | | |
USD$ |
3.75 | |
Risk-free interest rate | |
| 4.63 | % | |
| 4.54 | % |
Expected volatility | |
| 99 | % | |
| 101 | % |
Expected life in years | |
| 0.35 | | |
| 1.35 | |
Expected dividend yield | |
| Nil | | |
| Nil | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
a) Authorized share capital
The authorized share capital consists of an unlimited
number of common shares. The common shares do not have a par value. All issued shares are fully paid.
b)
Common shares issued
| |
Number of | | |
| |
| |
common shares | | |
Amount | |
Balance, December 31, 2022 | |
| 64,042,536 | | |
$ | 147,545,399 | |
Shares for services (i) | |
| 5,000 | | |
| 16,449 | |
Restricted share units exercised (note 9) | |
| 80,000 | | |
| 112,800 | |
Balance, June 30, 2023 | |
| 64,127,536 | | |
$ | 147,674,648 | |
| |
| | | |
| | |
Balance, December 31, 2023 | |
| 65,352,279 | | |
$ | 148,519,136 | |
Restricted share units exercised (note 9) | |
| 1,596,034 | | |
| 1,919,588 | |
Stock options exercised (note 9) | |
| 175,000 | | |
| 177,510 | |
Fair value of stock options exercised (note 9) | |
| - | | |
| 99,263 | |
Performance share units exercised (note 9) | |
| 2,200,000 | | |
| 1,634,038 | |
Balance, June 30, 2024 | |
| 69,323,313 | | |
$ | 152,349,535 | |
(i) During the six months ended June 30, 2023, the
Corporation issued 5,000 common shares with a fair value of $3,550. The fair value of the shares was determined to be equal to the
value of the services rendered. Included in shares for services is $12,899 related to vesting of previously issued shares.
The Corporation has adopted an Omnibus Equity
Incentive Plan in accordance with the policies of the TSX, which permits the grant or issuance of options, Restricted Share Units ("RSUs"),
Performance Share Units ("PSUs") and Deferred Share Units ("DSUs"), as well as other share-based payment arrangements.
The maximum number of shares that may be issued upon the exercise or settlement of awards granted under the plan may not exceed 15% of
the Corporation's issued and outstanding shares from time to time. The Board of Directors determines the price per common share and the
number of common shares which may be allotted to directors, officers, employees, and consultants, and all other terms and conditions
of the option, subject to the rules of the TSX.
During the three and six months ended June 30,
2024, the total expenses related to share-based compensation amounted to $1,805,586 and $2,707,686 (three and six months ended June 30,
2023 - $666,400 and $1,093,223). All outstanding awards are settleable with common shares and not cash.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
9. | Share-based payments (continued) |
(a) Stock
Options
| |
Number of | | |
Weighted average | |
| |
stock options | | |
exercise price ($) | |
Balance, December 31, 2022 | |
| 1,968,476 | | |
$ | 3.52 | |
Issued | |
| 500,000 | | |
| 1.20 | |
Expired | |
| (780,976 | ) | |
| 4.65 | |
Balance, June 30, 2023 | |
| 1,687,500 | | |
$ | 2.32 | |
| |
| | | |
| | |
Balance, December 31, 2023 | |
| 1,732,500 | | |
$ | 2.44 | |
Issued | |
| 455,000 | | |
| 2.56 | |
Expired | |
| (185,000 | ) | |
| 1.84 | |
Exercised (i) | |
| (175,000 | ) | |
| 1.01 | |
Balance, June 30, 2024 | |
| 1,827,500 | | |
$ | 2.68 | |
(i) The weighted average share price on date of exercise
was $2.62.
At the grant date, the fair value of stock options issued was estimated
using the Black-Scholes option pricing model based on the following weighted average assumptions:
|
|
Six Months
Ended
June 30,
2024 |
|
|
Six Months
Ended
June 30,
2023 |
|
Fair value of stock options at grant date |
|
$ |
1.79 |
|
|
$ |
0.65 |
|
Share price |
|
$ |
2.83 |
|
|
$ |
1.00 |
|
Exercise price |
|
$ |
2.56 |
|
|
$ |
1.20 |
|
Risk-free interest rate |
|
|
3.83 |
% |
|
|
3.74 |
% |
Expected volatility |
|
|
93 |
% |
|
|
89 |
% |
Expected life in years |
|
|
3.13 |
|
|
|
4.40 |
|
Expected dividend yield |
|
|
Nil |
|
|
|
Nil |
|
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
9. | Share-based payments (continued) |
The following table reflects the actual stock options issued and outstanding
as of June 30, 2024:
Expiry date | |
Exercise price ($) | | |
Weighted average remaining contractual life (years) | | |
Number of options outstanding | | |
Number of options vested (exercisable) | |
February 23, 2025 | |
| 3.54 | | |
| 0.65 | | |
| 20,000 | | |
| 20,000 | |
August 19, 2025 | |
| 2.12 | | |
| 1.14 | | |
| 100,000 | | |
| 100,000 | |
August 30, 2025 | |
| 5.00 | | |
| 1.17 | | |
| 80,000 | | |
| 80,000 | |
April 1, 2026 | |
| 5.77 | | |
| 1.75 | | |
| 60,000 | | |
| 60,000 | |
September 10, 2026 | |
| 1.37 | | |
| 2.20 | | |
| 25,000 | | |
| - | |
November 29, 2026 | |
| 2.46 | | |
| 2.42 | | |
| 250,000 | | |
| - | |
December 8, 2026 | |
| 3.59 | | |
| 2.44 | | |
| 325,000 | | |
| 216,667 | |
January 11, 2027 | |
| 2.18 | | |
| 2.53 | | |
| 220,000 | | |
| 146,667 | |
March 1, 2027 | |
| 2.56 | | |
| 2.67 | | |
| 350,000 | | |
| 87,500 | |
March 14, 2027 | |
| 2.07 | | |
| 2.70 | | |
| 60,000 | | |
| 40,000 | |
May 12, 2027 | |
| 1.46 | | |
| 2.87 | | |
| 70,000 | | |
| 46,667 | |
September 12, 2027 | |
| 1.61 | | |
| 3.20 | | |
| 207,500 | | |
| 69,168 | |
October 23, 2028 | |
| 1.20 | | |
| 4.32 | | |
| 30,000 | | |
| - | |
January 29, 2029 | |
| 2.56 | | |
| 4.59 | | |
| 30,000 | | |
| - | |
| |
| 2.68 | | |
| 2.50 | | |
| 1,827,500 | | |
| 866,669 | |
(b) Performance Share Units
| |
Number of
PSUs | |
Balance, December 31, 2022 and June 30, 2023 | |
| 600,000 | |
| |
| | |
Balance, December 31, 2023 | |
| 2,000,000 | |
Issued (i) | |
| 300,000 | |
Redeemed (ii) | |
| (2,200,000 | ) |
Balance, June 30, 2024 | |
| 100,000 | |
(i) Grants
of PSUs require completion of certain performance criteria specific to each grant. As the fair value of the services for all PSUs issued
cannot be reliably measured, the fair value was determined on the basis of the equity issued. The fair value of PSUs granted was determined
based on the Corporation's share price, adjusted by the estimated likelihood of the performance conditions being met.
(ii) The weighted average share price on date of exercise was $2.04.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
9. | Share-based payments (continued) |
(b) Performance Share Units (continued)
The following table reflects the actual PSUs issued and outstanding
as of June 30, 2024:
Expiry date | |
Weighted average remaining contractual life (years) | | |
Number of PSUs outstanding | | |
Number of PSUs vested (exercisable) | |
December 31, 2024 | |
| 0.50 | | |
| 100,000 | | |
| - | |
(i) Subsequent to
June 30, 2024, 700,000 PSUs were issued.
(ii) Subsequent to
June 30, 2024, 450,000 PSUs were redeemed.
(c) Restricted Share Units
| |
Number of RSUs | |
Balance, December 31, 2022 | |
| 2,312,963 | |
Issued (i) | |
| 1,125,000 | |
Redeemed (ii) | |
| (80,000 | ) |
Balance, June 30, 2023 | |
| 3,357,963 | |
| |
| | |
Balance, December 31, 2023 | |
| 3,544,887 | |
Redeemed (iii) | |
| (1,596,034 | ) |
Balance, June 30, 2024 | |
| 1,948,853 | |
(i) The fair value of
RSUs granted was determined based on the Corporation's share price.
(ii) The weighted average
share price on date of exercise was $0.80.
(iii) The weighted
average share price on date of exercise was $1.57.
The following table reflects the actual RSUs issued and outstanding as of June 30, 2024:
| |
Weighted average remaining | | |
Number of | | |
Number of RSUs | |
Expiry date | |
contractual life (years) | | |
RSUs outstanding | | |
vested (exercisable) | |
July 31, 2025 | |
| 1.08 | | |
| 1,914,639 | | |
| 1,452,727 | |
October 31, 2025 | |
| 1.34 | | |
| 34,214 | | |
| 34,214 | |
| |
| 1.09 | | |
| 1,948,853 | | |
| 1,486,941 | |
(i) Subsequent to June 30, 2024,
3,626,000 RSUs were issued.
(ii) Subsequent to June 30, 2024,
108,407 RSUs were redeemed.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
| |
Number of
warrants | | |
Amount | |
Balance, December 31, 2022 and June 30, 2023 | |
| 11,628,178 | | |
$ | 3,517,867 | |
| |
| | | |
| | |
Balance, December 31, 2023 | |
| 11,628,178 | | |
$ | 3,517,867 | |
Expired | |
| (3,453,178 | ) | |
| (3,517,867 | ) |
Balance, June 30, 2024 | |
| 8,175,000 | | |
$ | - | |
The following table reflects the actual warrants
issued and outstanding as of June 30, 2024, excluding 1,020,000 special warrants convertible automatically into common shares for
no additional consideration in accordance with the original escrow release terms as described in the Meros License Agreement (see note
5):
| |
Exercise | | |
Remaining contractual | | |
Warrants | |
Expiry date | |
price ($) | | |
life (years) | | |
exercisable | |
November 5, 2024(1) | |
| 5.13 | | |
| 0.35 | | |
| 8,175,000 | |
(1) Warrants carry an exercise price of
USD$3.75. This amount was translated to CAD for presentation purposes at the June 30, 2024 rate of 1.37. These warrants are classified
as a derivative liability on the statement of financial position (see note 7).
For the three and six months ended June 30,
2024, basic and diluted loss per share has been calculated based on the loss attributable to common shareholders of $6,590,873 and $15,770,505,
respectively (three and six months ended June 30, 2023 - $7,471,754 and $14,561,090, respectively) and the weighted average number
of common shares outstanding of 68,751,105 and 68,005,224, respectively (three and six months ended June 30, 2023 - 64,105,448 and
64,098,586, respectively). Diluted loss per share did not include the effect of stock options, PSUs, RSUs, and warrants as they are anti-dilutive.
(i) The
Corporation has leased premises with third parties. The minimum committed lease payments, which include the lease liability payments
shown as base rent, are approximately as follows:
| |
Base rent | | |
Variable rent | | |
Total | |
2024 | |
$ | 18,459 | | |
$ | 17,282 | | |
$ | 35,741 | |
2025 | |
| 55,376 | | |
| 51,846 | | |
| 107,222 | |
2026 | |
| 55,376 | | |
| 51,846 | | |
| 107,222 | |
2027 | |
| 55,376 | | |
| 51,846 | | |
| 107,222 | |
2028 | |
| 46,146 | | |
| 43,205 | | |
| 89,351 | |
| |
$ | 230,733 | | |
$ | 216,025 | | |
$ | 446,758 | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
12. | Commitments (continued) |
(ii) The
Corporation has signed various agreements with consultants to provide services. Under the agreements, the Corporation has the following
remaining commitments.
(iii) Pursuant
to the terms of agreements with various other contract research organizations, the Corporation is committed for the following contract
research services:
2024 | |
$ | 303,888 | |
2025 | |
| 1,176,824 | |
2026 | |
| 12,708 | |
Total | |
$ | 1,493,420 | |
The following details highlight certain components
of the research and development and general and administration expenses classified by nature. Remaining research and development and
operating expenses include personnel costs and expenses paid to third parties:
| |
Three Months
Ended | | |
Three Months
Ended | | |
Six Months
Ended | | |
Six Months
Ended | |
| |
June 30, | | |
June 30, | | |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses | |
| | | |
| | | |
| | | |
| | |
Non-cash share-based compensation | |
$ | 26,229 | | |
$ | 98,487 | | |
$ | 79,573 | | |
$ | 195,892 | |
| |
| | | |
| | | |
| | | |
| | |
General and administration expenses | |
| | | |
| | | |
| | | |
| | |
Depreciation of property and equipment | |
$ | 40,797 | | |
$ | 37,385 | | |
$ | 81,309 | | |
$ | 74,479 | |
Amortization of intangible assets | |
$ | 21,111 | | |
$ | 21,111 | | |
$ | 42,222 | | |
$ | 42,222 | |
Non-cash share-based compensation | |
$ | 1,779,357 | | |
$ | 567,913 | | |
$ | 2,628,113 | | |
$ | 897,331 | |
14. |
Related party transactions |
(a) The Corporation entered into the
following transactions with related parties:
(i) Included in research and development
expense is $109,129 and $737,809 for the three and six months ended June 30, 2023 paid to a company previously related to a director.
As at December 31, 2023, $416,792 was owed to this company and this amount was included in accounts payable and accrued liabilities.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated Financial Statements
Three
and Six Months Ended June 30, 2024
(Expressed in Canadian Dollars)
Unaudited |
14. | Related party transactions (continued) |
(b) Key
management personnel are those persons having authority and responsibility for planning, directing, and controlling the activities of
the Corporation directly or indirectly, including any directors (executive and non-executive) of the Corporation. Remuneration of directors
and key management personnel of the Corporation, except as noted in (a) above, was as follows:
| |
Three
Months
Ended | | |
Three
Months
Ended | | |
Six
Months
Ended | | |
Six
Months
Ended | |
| |
June 30, | | |
June 30, | | |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Salaries and benefits | |
$ | 540,335 | | |
$ | 534,446 | | |
$ | 1,804,739 | | |
$ | 1,704,476 | |
Share-based payments | |
| 154,291 | | |
| 262,128 | | |
| 275,731 | | |
| 531,010 | |
| |
$ | 694,626 | | |
$ | 796,574 | | |
$ | 2,080,470 | | |
$ | 2,235,486 | |
As at June 30, 2024, $nil (December 31, 2023 - $nil) was
owed to key management personnel and this amount was included in accounts payable and accrued liabilities.
Exhibit 99.2
CARDIOL THERAPEUTICS
INC.
MANAGEMENT'S DISCUSSION AND ANALYSIS
THREE AND SIX MONTHS ENDED
JUNE 30, 2024
MANAGEMENT’S
DISCUSSION AND ANALYSIS
Introduction
The following management’s
discussion and analysis (“MD&A”) of the financial condition and results of the operations of Cardiol Therapeutics Inc.
and its subsidiary (the “Corporation” or “Cardiol”) constitutes management of the Corporation's ("Management")
review of the factors that affected the Corporation’s financial and operating performance for the three and six months ended June 30,
2024 (the “2024 Fiscal Period”). This discussion should be read in conjunction with the consolidated financial statements
for the years ended December 31, 2023, 2022, and 2021 and the unaudited condensed interim consolidated financial statements for
the three and six months ended June 30, 2024 (“Financial Statements”), together with the respective notes thereto. Results
are reported in Canadian dollars, unless otherwise noted. The Financial Statements and the financial information contained in this MD&A
are derived from the Financial Statements prepared in accordance with International Accounting Standard 34, Interim Financial Reporting.
Accordingly, they do not include all of the information required for full annual financial statements required by International Financial
Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and Interpretations
issued by the International Financial Reporting Interpretations Committee (“IFRIC”). In the opinion of Management, all adjustments
(which consist only of normal recurring adjustments) considered necessary for a fair presentation have been included.
This MD&A is
dated August 12, 2024. All dollar amounts in this MD&A are reported in Canadian dollars, unless otherwise stated. Unless otherwise
noted or the context indicates otherwise, the terms “we”, “us”, “our”, “Cardiol”, the
"Company" or the “Corporation” refer to Cardiol Therapeutics Inc. and its subsidiary.
This MD&A is
presented current to August 12, 2024 unless otherwise stated. The financial information presented in this MD&A is derived from
the Financial Statements. This MD&A contains forward-looking statements that involve risks, uncertainties, and assumptions, including
statements regarding anticipated developments in future financial periods and our plans and objectives. There can be no assurance that
such information will prove to be accurate, and readers are cautioned not to place undue reliance on such forward-looking statements.
See “Forward-Looking Statements” and “Risk Factors”.
Forward-Looking
Information
This MD&A contains
forward-looking information that relates to the Corporation’s current expectations and views of future events. In some cases, this
forward-looking information can be identified by words or phrases such as “may”, “might”, "could",
“will”, “expect”, “anticipate”, “estimate”, “intend”, “plan”,
“indicate”, “seek”, “believe”, “predict”, or “likely”, or the negative of
these terms, or other similar expressions intended to identify forward-looking information. Statements containing forward-looking information
are not historical facts. The Corporation has based this forward-looking information on its current expectations and projections about
future events and financial trends that it believes might affect its financial condition, results of operations, business strategy, and
financial needs. The forward-looking information includes, among other things, statements relating to:
| · | our
anticipated cash needs, and the need for additional financing; |
| · | our
development of our product candidates for use in testing, research, preclinical studies,
clinical studies, and commercialization; |
| · | our
ability to develop new routes of administration of our product candidates, including parenteral,
for use in testing, research, preclinical studies, clinical studies, and commercialization; |
| · | our
ability to develop new formulations of our product candidates for use in testing, research,
preclinical studies, clinical studies, and commercialization; |
| · | the
successful development and commercialization of our current product candidates and the addition
of future products and product candidates; |
| · | the
ability of our product delivery technologies to deliver our product candidates to inflamed
and/or fibrotic tissue; |
| · | our
intention to build a pharmaceutical brand and our products focused on addressing inflammation
and fibrosis in heart disease, including acute myocarditis, recurrent pericarditis, and heart
failure; |
| · | the
expected medical benefits, viability, safety, efficacy, effectiveness, and dosing of our
product candidates; |
| · | patents
and intellectual property, including, but not limited to, our (a) ability to procure,
defend, and/or enforce our intellectual property relating to our products, product formulations,
routes of administration, product candidates, and associated uses, methods, and/or processes,
and (b) freedom to operate; |
| · | our
competitive position and the regulatory environment in which we operate; |
| · | the
molecular targets and mechanism of action of our product candidates; |
| · | our
financial position; our business strategy; our growth strategies; our operations; our financial
results; our dividend policy; our plans and objectives; and |
| · | expectations
of future results, performance, achievements, prospects, opportunities, or the market in
which we operate. |
In addition, any
statements that refer to expectations, intentions, projections, or other characterizations of future events or circumstances contain
forward-looking information. Forward-looking information is based on certain assumptions and analyses made by the Corporation in light
of the experience and perception of historical trends, current conditions, and expected future developments and other factors we believe
are appropriate and are subject to risks and uncertainties. The preceding list is not intended to be an exhaustive list of all of our
forward-looking statements. The forward-looking statements are based on our beliefs, assumptions and expectations of future performance,
taking into account the information currently available to us. These statements are only predictions based upon our current expectations
and projections about future events. Although we believe that the assumptions underlying these statements are reasonable, they may prove
to be incorrect, and we cannot assure that actual results will be consistent with this forward-looking information. Given these risks,
uncertainties, and assumptions, prospective investors should not place undue reliance on this forward-looking information. Whether actual
results, performance, or achievements will conform to the Corporation’s expectations and predictions is subject to a number of
known and unknown risks, uncertainties, assumptions, and other factors, including those listed under “Risk Factors”, which
include:
| · | the
inherent uncertainty of product development including testing, research, preclinical studies,
and clinical trials; |
| · | our
requirement for additional financing; |
| · | our
negative cash flow from operations; |
| · | dependence
on the success of our early-stage product candidates which may not generate revenue, if approved; |
| · | reliance
on Management, loss of members of Management or other key personnel, or an inability to attract
new Management team members; |
| · | our
ability to successfully design, initiate, execute, and complete clinical trials, including
the high cost, uncertainty, and delay of clinical trials and additional costs associated
with any failed clinical trials; |
| · | the
uncertainty our investigational products will have a therapeutic benefit in the clinical
indications we are pursuing; |
| · | potential
equivocal or negative results from clinical trials and their adverse impacts on our future
commercialization efforts; |
| · | our
ability to receive and maintain regulatory exclusivities in multiple jurisdictions, including
Orphan Drug Designations/Approvals, for our product candidates; |
| · | delays
in achievement of projected development goals; |
| · | management
of additional regulatory burdens; |
| · | volatility
in the market price for our securities; |
| · | failure
to protect and maintain and the consequential loss of intellectual property rights; |
| · | third-party
claims relating to misappropriation by the Corporation of their intellectual property; |
| · | reliance
on third parties to conduct and monitor our pre-clinical studies and clinical trials; |
| · | our
product candidates being subject to controlled substance laws which may vary from jurisdiction
to jurisdiction; |
| · | changes
in laws, regulations, and guidelines relating to our business, including tax and accounting
requirements; |
| · | our
reliance on early-stage research regarding the medical benefits, viability, safety, efficacy,
and dosing of our product candidates; |
| · | claims
for personal injury or death arising from the use of our future products and product candidates,
if approved; |
| · | uncertainty
relating to market acceptance of our product candidates; |
| · | our
lack of experience in commercializing any products, including selling, marketing, or distributing
pharmaceutical products; |
| · | securing
third-party payor reimbursement for our product candidates, if approved; |
| · | the
level of pricing and reimbursement for our product candidates, if approved; |
| · | our
dependence on contract manufacturers; |
| · | unsuccessful
collaborations with third parties; |
| · | business
disruptions affecting third-party suppliers and manufacturers; |
| · | lack
of control in future production and selling prices of our product candidates, if approved; |
| · | competition
in our industry; |
|
· |
our inability to develop new
technologies and products and the obsolescence of existing technologies and products; |
|
· |
unfavorable publicity or consumer
perception towards any products for which we receive marketing authorization; |
|
· |
product liability claims and
product recalls; |
|
· |
expansion of our business to
other jurisdictions; |
|
· |
fraudulent activities of employees,
contractors, and consultants; |
|
· |
our reliance on key inputs
and their related costs; |
|
· |
difficulty associated with
forecasting demand for products; |
|
· |
operating risk and insurance
coverage; |
|
· |
our inability to manage growth; |
|
· |
conflicts of interest among
the officers and directors ("Director") of the Corporation; |
|
· |
managing damage to our reputation
and third-party reputational risks; |
|
· |
relationships with customers
and third-party payors and consequential exposure to applicable anti-kickback, fraud, and abuse and other healthcare laws; |
|
· |
exposure to information systems
security threats; |
|
· |
no dividends for the foreseeable
future; |
|
· |
future sales of common shares
and warrants by existing shareholders causing the market price for the common shares and warrants to fluctuate; |
|
· |
the issuance of common shares
in the future causing dilution; |
|
· |
events outside of our control
could adversely affect our operations; |
|
· |
our ability to remediate any
material weakness in our internal control over financial reporting; |
|
· |
global geo-political events,
and the responses of governments having a significant effect on the world economy; and |
|
· |
failure to meet regulatory
or ethical expectations on environmental impact, including climate change. |
If any of these
risks or uncertainties materialize, or if assumptions underlying the forward-looking information prove incorrect, actual results may
vary materially from those anticipated in the forward-looking information.
Information contained
in forward-looking information in this MD&A is provided as of August 12, 2024, and we disclaim any obligation to update any
forward-looking information, whether as a result of new information or future events or results, except to the extent required by applicable
securities laws. Accordingly, potential investors should not place undue reliance on forward-looking information.
Overview
On December 20,
2018, the Corporation completed its initial public offering on the Toronto Stock Exchange (the "TSX"). As a result, the common
shares commenced trading on the TSX under the symbol "CRDL". On August 10, 2021, the Corporation's common shares commenced
trading on The Nasdaq Capital Market under the symbol "CRDL".
The Corporation
is a clinical-stage life sciences company focused on the research and clinical development of anti- inflammatory and anti-fibrotic therapies
for the treatment of heart diseases. The Corporation's lead drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically
manufactured and is currently in clinical development for use in the treatment of two heart diseases. It is recognized that cannabidiol
inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression
of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received
Investigational New Drug Application ("IND") authorization from the United States Food and Drug Administration (“FDA”)
to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two rare diseases affecting the heart: (i) a Phase
II multi-center open-label pilot study in recurrent pericarditis (the "MAvERIC-Pilot" study; NCT05494788), an inflammatory
disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and
results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II
multi-national, randomized, double-blind, placebo-controlled trial (the "ARCHER" trial; NCT05180240) in acute myocarditis,
an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than
35 years of age.
The FDA has granted
Orphan Drug Designation to CardiolRx for the treatment of pericarditis, which includes recurrent pericarditis. The U.S. Orphan Drug Designation
program was created to provide the sponsor of a drug or biologic significant incentives, including seven-year marketing exclusivity and
exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. Products with
Orphan Drug Designation also frequently qualify for accelerated regulatory review. The European Commission's European Medicines Agency
("EMA") has a similar orphan medicine product program for rare diseases.
Cardiol is also
developing a novel subcutaneously administered drug formulation of its lead small molecule drug candidate ("CRD-38") intended
for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs
in the U.S. exceeding $30 billion annually1.
Operations Highlights
During the 2024
Fiscal Period
(i) In January 2024,
the Corporation announced it has exceeded 50% patient enrollment for ARCHER. See "Phase II Trial – Acute Myocarditis (ARCHER)".
(ii) In
January 2024, the Corporation announced that it received notice on January 23, 2024 from The Nasdaq Stock Market LLC stating
the Corporation had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued
listing on The Nasdaq Capital Market.
(iii) In
February 2024, the Corporation announced that the FDA has granted Orphan Drug Designation to CardiolRx for the treatment of pericarditis,
which includes recurrent pericarditis.
(iv) In
February 2024, the Corporation announced completion of patient enrollment in MAvERIC-Pilot. See "Phase II Open Label Pilot
Study - Recurrent Pericarditis (MAvERIC-Pilot)".
(v) In
May 2024, the Corporation announced its Phase II ARCHER trial was the subject of an oral presentation at the World Congress on Acute
Heart Failure 2024 in Lisbon, Portugal at the annual congress of the Heart Failure Association of the European Society of Cardiology
(“ESC”).
The trial design,
rationale, and blinded baseline data on the first 50 patients randomized into ARCHER was presented by Univ.-Prof. Dr. med. Carsten
Tschöpe from the Berlin Institute of Health – Charité on behalf of the ARCHER Study Group, an independent steering
committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence who contributed
to the design and execution of ARCHER. Concurrent with the presentation the journal ESC Heart Failure, which is dedicated to advancing
knowledge about heart failure worldwide, accepted the manuscript describing the rationale and design of the ARCHER trial and it was published
in June 2024.
(vi) In
June 2024, the Corporation reported positive topline 8-week clinical data from its Phase II open-label MAvERIC- Pilot study investigating
the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The data showed a marked reduction in
the primary efficacy endpoint of patient-reported pericarditis pain at the end of the 8-week treatment period (“TP”), as
well as normalization of inflammation – as measured by C-reactive protein (“CRP”) – in 80% of patients with elevated
CRP at baseline.
MAvERIC-Pilot study
enrolled 27 patients diagnosed with symptomatic recurrent pericarditis. Each patient had a high disease burden as reflected in the mean
baseline pericarditis pain score of 5.8 out of 10, and by the number of previous episodes of pericarditis: 9 patients (33%) with 2 previous
episodes; 9 (33%) with 3; 4 (15%) with 4; and 5 (19%) with >4.
Summary of topline
findings include:
| · | Primary
endpoint of patient-reported pericardial pain on an 11-point numerical rating scale (“NRS”)
showed a mean reduction of 3.7, from 5.8 at baseline (range of 4 to 10) to 2.1 (range of
0 to 6) at 8 weeks. NRS is a validated instrument used to assess patient-reported pericarditis
pain. Zero represents ‘no pain at all’, whereas the upper limit of 10 represents
‘the worst pain ever possible’. |
| · | Eight
of the ten patients (80%) with a baseline CRP =1mg/dL had a normalization of CRP (=0.5 mg/dL)
at 8 weeks. The mean CRP decreased from 5.7 mg/dL at baseline to 0.3 mg/dL at 8 weeks. CRP
is a commonly used clinical marker of inflammation, and in combination with the NRS score,
is used by clinicians to assess clinical response and determine a recurrence. |
| · | Eighty-nine
percent of patients (24/27) have progressed from the TP into the extension period (“EP”)
of the study, defined as the additional 18-week period of CardiolRx™ treatment that
follows the TP. |
| · | CardiolRx™
was shown to be generally well-tolerated. |
Phase II
Open Label Pilot Study – Recurrent Pericarditis (MAvERIC-Pilot)
Pericarditis refers
to inflammation of the pericardium (the membrane or sac that surrounds the heart), frequently resulting from a viral infection. Recurrent
pericarditis is the reappearance of symptoms after a symptom-free period of at least four to six weeks following the initial acute episode
of pericarditis. Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue,
resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Causes of pericarditis
can include infection (e.g., tuberculosis), systemic disorders such as autoimmune and inflammatory diseases, cancer, and post-cardiac
injury syndromes. Pericarditis (and its recurrences) are symptomatic events, the diagnosis of which is based on meeting two of four criteria:
chest pain; pericardial friction rub; electrocardiogram changes; and new or worsening pericardial swelling. Elevation of inflammatory
markers such as C-reactive protein ("CRP"), and evidence of pericardial inflammation by an imaging technique (computed tomography
scan or cardiac magnetic resonance) may help the diagnosis and the monitoring of disease activity. Although generally self-limited and
not life threatening, pericarditis is diagnosed in 0.2% of all cardiovascular in-hospital admissions and is responsible for 5% of emergency
room admissions for chest pain in North America and Western Europe2.
Recurrent pericarditis
appears in 15% to 30% of patients following the acute index episode and usually within 18 months. Furthermore, up to 50% of patients
with a recurrent episode of pericarditis experience more recurrences. Standard first-line medical therapy consists of non-steroidal anti-inflammatory
drugs or aspirin with or without colchicine. Corticosteroids such as prednisone are second-line therapy in patients with continued recurrence
and inadequate response to conventional therapy. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is a costly
and potent subcutaneously injected interleukin-1 inhibitor with immunosuppressive effects. It is generally used as a third-line intervention
in patients with persistent underlying disease, multiple recurrences, and an inadequate response to conventional therapy2.
On an annual basis,
the number of patients in the U.S. having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with
multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization
due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between US$20,000
and US$30,000 in the U.S.2.
In May 2022,
the Corporation announced the FDA has authorized the Corporation's IND to commence a Phase II open- label pilot study designed to evaluate
the tolerance, safety, and efficacy of CardiolRx in patients with recurrent pericarditis. MAvERIC-Pilot will also assess the improvement
in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including
corticosteroids, while taking CardiolRx. Recurrent pericarditis is a rare disease in the U.S., and in February 2024, the FDA granted
Orphan Drug Designation to CardiolRx for the treatment of pericarditis, which includes recurrent pericarditis.
The MAvERIC-Pilot
study, designed to enroll 25 patients, enrolled 27 patients at eight major clinical centers in the U.S. specializing in pericarditis.
The primary efficacy endpoint of the study is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an
11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool used across multiple conditions with acute and
chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment,
and changes in high sensitivity CRP. Importantly, the study will also assess freedom from pericarditis recurrence.
The MAvERIC-Pilot
study was designed with the support of an independent Advisory Committee and key trial investigators, consisting of international thought
leaders in cardiovascular disease, including:
| · | Study
Chair: Allan Klein, MD, CM – Director, Center for the Diagnosis and Treatment of
Pericardial Diseases, and Professor of Medicine, Heart, Vascular and Thoracic Institute,
Cleveland Clinic; |
| · | Antonio
Abbate, MD – Ruth C. Heede Professor of Cardiology, School of Medicine, and Department
of Medicine, Division of Cardiovascular Medicine - Heart and Vascular Center, University
of Virginia; |
| · | Allen
Luis, MBBS, PhD – Co-Director of the Pericardial Diseases Clinic, Associate Professor
of Medicine, Department of Cardiovascular Medicine, at Mayo Clinic Rochester Minnesota; |
| · | Paul
Cremer, MD – Departments of Medicine and Radiology, Northwestern University, and
Multimodality Cardiac Imaging and Clinical Trials Unit, Bluhm Cardiovascular Institute; |
| · | Stephen
Nicholls – Program Director, Victorian Heart Hospital, Director, Monash Victorian
Heart Institute, and Professor of Cardiology, Monash University, Melbourne; and |
| · | Stefano
Toldo, PhD – Associate Professor of Medicine, Department of Medicine, Cardiovascular
Medicine at University of Virginia. |
In June 2024,
the Corporation reported positive topline 8-week clinical data from its MAvERIC-Pilot study. The data showed a marked reduction in the
primary efficacy endpoint of patient-reported pericarditis pain at the end of the 8- week treatment period (“TP”), as well
as normalization of inflammation – as measured by C-reactive protein (“CRP”) – in 80% of patients with elevated
CRP at baseline.
MAvERIC-Pilot study
enrolled 27 patients diagnosed with symptomatic recurrent pericarditis. Each patient had a high disease burden as reflected in the mean
baseline pericarditis pain score of 5.8 out of 10, and by the number of previous episodes of pericarditis: 9 patients (33%) with 2 previous
episodes; 9 (33%) with 3; 4 (15%) with 4; and 5 (19%) with >4.
Summary of topline
findings include:
| · | Primary
endpoint of patient-reported pericardial pain on an 11-point numerical rating scale (“NRS”)
showed a mean reduction of 3.7, from 5.8 at baseline (range of 4 to 10) to 2.1 (range of
0 to 6) at 8 weeks. NRS is a validated instrument used to assess patient-reported pericarditis
pain. Zero represents ‘no pain at all’, whereas the upper limit of 10 represents
‘the worst pain ever possible’. |
| · | Eight
of the ten patients (80%) with a baseline CRP =1mg/dL had a normalization of CRP (=0.5 mg/dL)
at 8 weeks. The mean CRP decreased from 5.7 mg/dL at baseline to 0.3 mg/dL at 8 weeks. CRP
is a commonly used clinical marker of inflammation, and in combination with the NRS score,
is used by clinicians to assess clinical response and determine a recurrence. |
| · | Eighty-nine
percent of patients (24/27) have progressed from the TP into the extension period (“EP”)
of the study, defined as the additional 18-week period of CardiolRx™ treatment that
follows the TP. |
| · | CardiolRx™
was shown to be generally well-tolerated. |
The Corporation
expects to report full results including extension period data during H2 2024. Cardiol has budgeted costs to complete this study to be
approximately $500,000. If Cardiol determines that the study has met its objectives, it currently expects to undertake the next steps
in its clinical development program, which would consist of a larger clinical study, the details of which will be determined in conjunction
with its external clinical advisors and regulatory agencies. The total cost and timeline to complete this clinical development program
cannot be determined at this stage as this will depend on a variety of factors. The Corporation may involve a commercial partner from
the pharmaceutical industry to fund the late-stage clinical development and commercialization of CardiolRx for the treatment of recurrent
pericarditis.
Phase II
Trial – Acute Myocarditis (ARCHER)
Myocarditis is
an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, impaired cardiac function, atrial and ventricular
arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant
heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Although viral infection is the most common
cause of myocarditis, the condition can also result from administration of therapies used to treat several common cancers, including
chemo- therapeutic agents and immune checkpoint inhibitors3.
In a proportion
of patients, the inflammation in the heart persists and causes decreased heart function with symptoms and signs of heart failure, and
as such pharmacological treatment is based on conventional therapy for heart failure. This includes diuretics, ACE inhibitors, angiotensin
receptors blockers, beta blockers, and aldosterone inhibitors. For those with a fulminant presentation, intensive care is often required,
with the use of inotropic medications (to increase the force of the heart muscle contraction). Severe cases frequently require ventricular
assist devices or extracorporeal oxygenation and may necessitate heart transplantation. There are no FDA-approved therapies for acute
myocarditis. Patients hospitalized with acute myocarditis experience an average 7-day length of stay and a 4 - 6% risk of in-hospital
mortality, with average hospital charge per stay estimated at US$110,000 in the U.S.3.
Data from multiple
sources, including the ‘Global Burden of Disease Study’, reports that the number of cases per year of myocarditis range from
approximately 10 to 22/100,000 persons (estimated U.S. patient population of 33,000 to 73,000), qualifying the condition as a rare disease
in the U.S. and in European Union. Cardiol believes that there is a significant opportunity to develop a therapy for acute myocarditis
that may be eligible for designation as an orphan drug under the FDA's Orphan Drug Designation and the European Medicines Agency Orphan
Medicine programs3.
In August 2021,
Cardiol received IND authorization from the FDA to conduct a Phase II clinical trial of CardiolRx in acute myocarditis - the ARCHER trial.
ARCHER has also received regulatory clearance in other jurisdictions and is expected to enroll 100 patients at major cardiac centers
in North America, Europe, Latin America and Israel. In May 2024, the Corporation announced that the ARCHER trial had exceeded 85%
of its patient enrollment objective. ARCHER has been designed in collaboration with an independent steering committee comprising distinguished
thought leaders in heart failure and myocarditis from international centers of excellence. The primary endpoints of the trial, which
will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left
ventricular function (global longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown
to predict long-term prognosis of patients with acute myocarditis.
Members of the
Steering Committee include:
| · | Chair:
Dennis M. McNamara, MD – Professor of Medicine at the University of Pittsburgh.
He is also the Director of the Heart Failure/Transplantation Program at the University of
Pittsburgh Medical Center; |
| · | Co-Chair:
Leslie T. Cooper, Jr., MD – General cardiologist and the Chair of the Mayo
Clinic Enterprise Department of Cardiovascular Medicine, as well as chair of the Department
of Cardiovascular Medicine at the Mayo Clinic in Florida; |
| · | Arvind
Bhimaraj, MD – Specialist in Heart Failure and Transplantation Cardiology and Associate
Professor of Cardiology, Institute for Academic Medicine at Houston Methodist and at
Weill Cornell Medical College, NYC; |
| · | Wai
Hong Wilson Tang, MD – Advanced Heart Failure and Transplant Cardiology specialist
at the Cleveland Clinic in Cleveland, Ohio. Dr. Tang is also the Director of the Cleveland
Clinic's Center for Clinical Genomics; Research Director, and staff cardiologist in the Section of
Heart Failure and Cardiac Transplantation Medicine in the Sydell and Arnold Miller Family
Heart & Vascular Institute at the Cleveland Clinic; |
| · | Peter
Liu, MD – Chief Scientific Officer and Vice President, Research, of the University
of Ottawa Heart Institute, and Professor of Medicine and Physiology at the University of
Toronto and University of Ottawa; |
| · | Carsten
Tschöpe, MD – Clinical Professor in Cardiology, Head of the Cardiomyopathy
Unit, Department of Cardiology, Angiology and Intensive Care, Campus Virchow, German Heart
Center (DHZC) at Charité, Berlin;. |
| · | Matthias
Friedrich, MD – Full Professor within the Departments of Medicine and Diagnostic
Radiology at McGill University in Montreal, and Chief, Cardiovascular Imaging at the McGill
University Health Centre; |
| · | Yaron
Arbel, MD – Cardiologist and Director of the CardioVascular Research Center (CVRC)
at the Tel Aviv "Sourasky" Medical Center; |
| · | Edimar
Bocchi, MD – Serves as the Head of Heart Failure Clinics and Heart Failure Team
at Heart Institute (Incor) of Hospital das Clinicas of São Paulo University Medical
School, Associate Professor of São University Medical School, São Paulo, Brazil;
and |
| · | Mathieu
Kerneis, MD, PhD – Interventional cardiologist at Pitié Salpêtrière
Hospital (Sorbonne University). |
In May 2024,
the ARCHER trial was the subject of an oral presentation at the World Congress on Acute Heart Failure 2024 in Lisbon, Portugal at the
annual congress of the Heart Failure Association of the ESC. The trial design, rationale, and blinded baseline data on the first 50 patients
randomized into ARCHER was presented by Univ.-Prof. Dr. med. Carsten Tschöpe from the Berlin Institute of Health – Charité
on behalf of the ARCHER Study Group, an independent steering committee comprising distinguished thought leaders in heart failure and
myocarditis from international centers of excellence who contributed to the design and execution of ARCHER. Concurrent with the presentation
the journal ESC Heart Failure, which is dedicated to advancing knowledge about heart failure worldwide, accepted the manuscript describing
the rationale and design of the ARCHER trial and it was published in June 2024.
It is anticipated
that patient recruitment will be completed during Q3 2024 and the Corporation expects to report topline data in Q1 2025. Cardiol has
budgeted costs to complete this study to be approximately $4 million. If Cardiol determines that the Phase II study meets its objectives,
it currently expects to undertake the next steps of its clinical development program, which would consist of a larger clinical study,
the details of which will be determined in consultation with its external clinical advisors and regulatory agencies. The total cost and
timeline to complete this clinical development program cannot be determined at this stage as this will depend on a variety of factors.
The Corporation may involve a commercial partner from the pharmaceutical industry, to fund the late-stage clinical development and commercialization
of CardiolRx for the treatment of acute myocarditis.
Scientific
Advisory Board
The Corporation
has established a Scientific Advisory Board comprised of distinguished thought leaders in cardiovascular medicine. These individuals
will lend their expertise in cardiovascular research and provide invaluable guidance to the Corporation's research and clinical programs.
The Scientific Advisory Board members include:
Paul M. Ridker,
MD, MPH
Dr. Ridker
is director of the Center for Cardiovascular Disease Prevention, a translational research unit at Brigham and Women’s Hospital
(BWH), Boston. A cardiovascular medicine specialist, he is also the Eugene Braunwald Professor of Medicine at Harvard School of Medicine
(HMS). Dr. Ridker received his medical degree from HMS and then completed an internal medicine residency and a cardiology fellowship
at BWH. Dr. Ridker is board certified in internal medicine. His clinical interests include coronary artery disease and the underlying
causes and prevention of atherosclerotic disease. Dr. Ridker is the author of over 900 peer-reviewed publications and reviews, 64
book chapters, and six textbooks related to cardiovascular medicine. His primary research focus has involved inflammatory mediators of
heart disease and the molecular and genetic epidemiology of hemostasis and thrombosis, with particular interests in biomarkers for coronary
disease, “predictive” medicine, and the underlying causes and prevention of atherosclerotic disease. Notably, Dr. Ridker
has been the Principal Investigator or Study Chair of several large international trials that have demonstrated the role of inflammation
in the genesis and management of coronary artery disease. He was included in TIME magazine’s list of 100 most influential people
of 2004, and between the years 2000 and 2010, Dr. Ridker was among the ten most often cited researchers in cardiovascular medicine
worldwide. Amongst many other honors, he received the American Heart Association Distinguished Scientist Award in 2013, gave the Braunwald
Lecture of the American College of Cardiology in 2019, was awarded the Gotto Prize for Atherosclerosis Research from the International
Atherosclerosis Society in 2021, and is an elected Member of the National Academy of Medicine (USA).
Bruce McManus,
PhD, MD
Dr. McManus
is Professor Emeritus, Department of Pathology and Laboratory Medicine, the University of British Columbia. He has served as CEO, Centre
of Excellence for Prevention of Organ Failure (PROOF Centre), Director, UBC Centre for Heart Lung Innovation, and Scientific Director, Institute
of Circulatory and Respiratory Health, CIHR. Dr. McManus received BA and MD degrees (University of Saskatchewan), an MSc (Pennsylvania
State University), and a PhD (University of Toledo). He pursued post-doctoral fellowships at the University of California, Santa Barbara
(Environmental Physiology) and at the National Heart, Lung, and Blood Institute, Bethesda, MD (Cardiovascular & Pulmonary Pathology),
and residency training at the Peter Bent Brigham Hospital, Harvard University (Internal Medicine and Pathology). Dr. McManus’
investigative passion relates to mechanisms, consequences, detection and prevention of injury and aberrant repair in inflammatory diseases
of the heart and blood vessels. He has had a longstanding interest in the diagnosis and management of acute viral myocarditis. His life’s
scholarship is reflected in more than 400 original peer-reviewed publications, over 60 chapters, and several books. He is an extraordinary
mentor. Dr. McManus has been widely appreciated for his research, mentoring, and leadership contributions to the health sciences.
Amongst many awards and honors, Dr. McManus received the prestigious Max Planck Research Award in 1991, was elected a Fellow of
the Royal Society of Canada in 2002, was appointed a Member of the Order of Canada in 2018, and to the Order of British Columbia the
following year.
Joseph A. Hill,
MD, PhD
Dr. Hill is
Professor of Internal Medicine and Molecular Biology, Chief of Cardiology at UT Southwestern Medical Center, Dallas, TX, and Director
of the Harry S. Moss Heart Center. Dr. Hill holds both the James T. Willerson, MD, Distinguished Chair in Cardiovascular Diseases,
and the Frank M. Ryburn Jr. Chair in Heart Research. He graduated from Duke University with MD and PhD degrees in 1987. His PhD dissertation
research was in the field of cardiac ion channel biophysics. Dr. Hill then worked for five years as a postdoctoral fellow at the
Institut Pasteur in Paris studying central and peripheral nicotinic receptors. He next completed an internal medicine internship and
residency, as well as a clinical cardiology fellowship, at the Brigham and Women’s Hospital, Harvard Medical School. He served
on faculty at the University of Iowa for five years before moving in 2002 to the UT Southwestern. Dr. Hill’s research examines
molecular mechanisms of structural, functional, metabolic, and electrophysiological remodeling in cardiac hypertrophy and heart failure.
He has served on many NIH panels and committees and delivered numerous invited lectures in the U.S. and around the world. Dr. Hill
has received many recognitions and awards, including election to the Association of American Professors and the 2018 Research Achievement
Award from the International Society for Heart Research. For the past eight years, Dr. Hill has been the Editor-in-Chief of the
prestigious American Heart Association journal Circulation.
Outlook
During the next 12 months, the Corporation
expects to achieve the following corporate milestones:
| · | Complete
Phase II MAvERIC-Pilot study evaluating CardiolRx in recurrent pericarditis and report full
results including extension period data during H2 2024; |
| · | Complete
Phase II ARCHER trial in acute myocarditis with CardiolRx and report topline data
in Q1, 2025; |
| · | Advance
the development of CRD-38 into a clinical program; |
The Corporation
expects that the June 30, 2024, cash and cash equivalents of $24,021,237 will be sufficient to fund operations and capital requirements
associated with achieving these corporate milestones, into 2026.
Summary of Quarterly Results
The Corporation’s quarterly information
in the table below is prepared in accordance with IFRS.
| |
Total | |
Profit
or (Loss) | | |
Total | |
Three Months
Ended | |
Revenue ($) | |
Total
($) | | |
Per
Share(9) ($) | | |
Assets ($) | |
June 30, 2024(1) | |
nil | |
| (6,590,873 | ) | |
| (0.10 | ) | |
| 26,312,660 | |
March 31, 2024(2) | |
nil | |
| (9,179,632 | ) | |
| (0.14 | ) | |
| 31,126,280 | |
December 31, 2023(3) | |
nil | |
| (7,637,017 | ) | |
| (0.12 | ) | |
| 36,700,508 | |
September 30, 2023(4) | |
nil | |
| (5,930,185 | ) | |
| (0.11 | ) | |
| 43,053,024 | |
June 30, 2023(5) | |
nil | |
| (7,471,754 | ) | |
| (0.12 | ) | |
| 47,169,272 | |
March 31, 2023(6) | |
nil | |
| (7,089,336 | ) | |
| (0.11 | ) | |
| 52,685,268 | |
December 31, 2022(7) | |
nil | |
| (7,515,018 | ) | |
| (0.12 | ) | |
| 62,028,518 | |
September 30, 2022(8) | |
nil | |
| (7,972,047 | ) | |
| (0.13 | ) | |
| 68,358,729 | |
Note:
| 1. | Net
loss of $6,590,873 included general and administration of $5,031,702, research and development
of $2,709,644. These are partially offset by a change in derivative liability of $691,047,
a gain on foreign exchange of $152,017, and interest income of $307,409. |
| 2. | Net
loss of $9,179,632 included general and administration of $5,082,552, research and development
of $3,322,929 and change in derivative liability of $1,808,603. These are partially offset
by the gain on foreign exchange of $628,935, interest income of $377,294, and other income
of $28,223. |
| 3. | Net
loss of $7,637,017 included general and administration of $3,988,373, research and development
of $4,040,455, and a loss on foreign exchange of $628,148. These are partially offset by
interest income of $448,303, and a change in derivative liability of $571,656. |
| 4. | Net
loss of $5,930,185 included general and administration of $5,079,140, and research and development
of $2,576,751. This is partially offset by a gain on foreign exchange of $667,548, interest
income of $515,538, a change in derivative liability of $392,881, and other income of $149,739. |
| 5. | Net
loss of $7,471,754 included research and development of $3,479,385, general and administration
of $2,835,264, change in derivative liability of $856,893, and loss on foreign exchange of
$828,909. These are partially offset by interest income of $528,697. |
| 6. | Net
loss of $7,089,336 included research and development of $4,127,696, and general and administration
of $3,658,440. These are partially offset by interest income of $545,927. |
| 7. | Net
loss of $7,515,018 included research and development of $5,617,948, general and administration
of $3,477,065, and a loss on foreign exchange of $528,314. These are partially offset by
a change in derivative liability of $1,523,662 and interest income of $584,647. |
| 8. | Net
loss of $7,972,047 included general and administration of $8,130,743, and research and development
of $5,089,423. These are partially offset by the gain on foreign exchange of $2,970,896,
and change in derivative liability of $1,723,442. |
| 9. | Basic
and fully diluted. |
Discussion of Operations
Six months ended June 30, 2024,
compared to the six months ended June 30, 2023
For the six months
ended June 30, 2024, the Corporation’s net loss was $15,770,505, compared to a net loss of $14,561,090 for the six months
ended June 30, 2023. The increase in net loss of $1,209,415 is a result of the following:
| · | Research
and development decreased to $6,032,573 for the six months ended June 30, 2024, compared
to $7,607,081 for the six months ended June 30, 2023. During the six months ended June 30,
2024, the Corporation incurred research and development costs related to basic science, pre-clinical
studies, and clinical studies, specifically relating to the ARCHER and MAvERIC-Pilot, in
the amount of $2,775,974 and $1,206,452, respectively. This compares to $2,522,248 and $1,038,287,
respectively, relating to ARCHER and MAvERIC-Pilot for the six months ended June 30,
2023. |
| · | General
and administration expenses increased to $10,114,254 for the six months ended June 30,
2024, compared to $6,493,704 for the six months ended June 30, 2023. The increase was
a result of an increase in corporate communications spending, as well as an increase in share-based
compensation, mainly related to the vesting of Performance Share Units. |
| · | The
net loss for the six months ended June 30, 2024, included a loss on the change in derivative
liability, based on the revaluation as at June 30, 2024, of $1,117,556, compared to
the loss on the change in derivative liability for the six months ended June 30, 2023,
of $782,812. |
| · | The
net loss included a gain on foreign exchange during the six months ended June 30, 2024,
of $780,952, compared to a loss on foreign exchange during the six months ended June 30,
2023 of $752,117. This is mainly the result of the revaluation of funds held in USD. |
| · | The
net loss is partially offset by interest income during the six months ended June 30,
2024, of $684,703, compared to interest income during the six months ended June 30,
2023 of $1,074,624. The decrease is the result of a decrease in cash balance. |
Three months ended June 30,
2024, compared to the three months ended June 30, 2023
For the three months
ended June 30, 2024, the Corporation’s net loss was $6,590,873, compared to a net loss of $7,471,754 for the three months
ended June 30, 2023. The decrease in net loss of $880,881 is a result of the following:
| · | Research
and development decreased to $2,709,644 for the three months ended June 30, 2024, compared
to $3,479,385 for the three months ended June 30, 2023. During the three months ended
June 30, 2024, the Corporation incurred research and development costs related to basic
science, pre-clinical studies, and clinical studies, specifically relating to the ARCHER
and MAvERIC-Pilot, in the amount of $1,389,279 and $499,955, respectively. This compares
to $1,118,857 and $307,266, respectively, relating to ARCHER and MAvERIC-Pilot for the three
months ended June 30, 2023. |
| · | General
and administration expense increased to $5,031,702 for the three months ended June 30,
2024, compared to $2,835,264 for the three months ended June 30, 2023. The increase
was a result of an increase in corporate communications spending and share-based compensation,
mainly related to the vesting of Performance Share Units. |
| · | The
net loss for the three months ended June 30, 2024, is partially offset by the gain on
the change in derivative liability, based on the revaluation as at June 30, 2024, of
$691,047, compared to the loss on the change in derivative liability for the three months
ended June 30, 2023 of $856,893. |
| · | The
net loss included a gain on foreign exchange during the three months ended June 30,
2024 of $152,017. compared to a loss on foreign exchange during the three months ended June 30,
2023 of $828,909. This is mainly the result of the revaluation of funds held in USD. |
| · | The
net loss is partially offset by interest income during the three months ended June 30,
2024, of $307,409, compared to interest income during the three months ended June 30,
2023 of $528,697. The decrease is the result of a decrease in cash balance. |
Capital Management
The Corporation
manages its capital to ensure sufficient financial flexibility to achieve the ongoing business objectives including research activities,
funding of future growth opportunities, and pursuit of acquisitions.
The Corporation
monitors its capital structure and makes adjustments according to market conditions in an effort to meet its objectives given the current
outlook of the business and industry in general. The Corporation may manage its capital structure by issuing new shares, repurchasing
outstanding shares, adjusting capital spending, or disposing of assets. The capital structure is reviewed by Management and the Board
of Directors on an ongoing basis.
The Corporation
considers its capital to be total equity, comprising share capital, warrants, and contributed surplus, less accumulated deficit, which
at June 30, 2024, totaled $15,361,198 (December 31, 2023 – $28,246,507).
The Corporation
manages capital through its financial and operational forecasting processes. The Corporation reviews its working capital and forecasts
its future cash flows based on operating expenditures, and other investing and financing activities. The forecast is updated based on
activities related to its research programs and reviewed with the Board of Directors of the Corporation.
The Corporation
is not currently subject to any capital requirements imposed by a lending institution or regulatory body. The Corporation expects that
its capital resources will be sufficient to discharge its liabilities as of the current statement of financial position date.
Off-Balance
Sheet Arrangements
As of the date
of this MD&A, the Corporation does not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current
or future effect on the results of operations or financial condition of the Corporation, including, and without limitation, such considerations
as liquidity and capital resources.
Liquidity and
Capital Resources
At June 30,
2024, Cardiol had $24,021,237 in cash and cash equivalents (December 31, 2023 – $34,931,778).
At June 30,
2024, accounts payable and accrued liabilities were $9,431,457 (December 31, 2023 – $8,041,485). The Corporation’s cash
and cash equivalents balances as at June 30, 2024, and December 31, 2023, are sufficient to pay these liabilities.
The Corporation
currently has no operating revenues and therefore must utilize its funds from financing transactions to maintain its capacity to meet
ongoing operating activities. Future financing may come from product sales, licensing arrangements, research and commercial development
partnerships, government grants, and/or corporate finance arrangements.
We expect to continue
to incur substantial losses as we continue our research and development efforts. We continue to manage our research and development plan
to ensure optimal use of our existing resources as we expect to fund our operations and capital requirements, associated with achieving
our corporate milestones, with existing working capital (See “Outlook”). We expect to continue to incur additional costs
associated with operating as a public company. Factors that may affect our anticipated cash usage, but are not limited to, expansion
of our clinical trial programs, the timing of patient enrollment in our clinical trials, the actual costs incurred to support each clinical
trial, the number of treatments each patient will receive, the timing of research and development activity with our clinical trial research
collaborations, and other factors described in the "Risk Factors" section.
As of June 30,
2024, December 31, 2023, and to the date of this MD&A, the cash resources of Cardiol are held with one Canadian chartered bank.
The Corporation has no variable interest rate debt and its credit and interest rate risk are minimal. Accounts payable and accrued liabilities
are short-term and non-interest bearing.
For the 2024
Fiscal Period
Cash and cash equivalents
used in operating activities were $11,698,496 for the six months ended June 30, 2024. Operating activities were affected by a net
loss of $15,770,505 and the net change in non-cash working capital balances of $751,008, and partially offset by other non-cash adjustments
of $3,321,001. Non-cash adjustments mainly consisted of $2,707,686 for share-based compensation, $1,117,556 for change in derivative
liability and $(640,778) for unrealized foreign exchange gain on cash. Non-cash working capital was mainly the result of an increase
in accounts payable and accrued liabilities of $1,389,972, partially offset by an increase in prepaid expenses of $676,412.
Cash and cash equivalents
used in investing activities were $7,260 for the six months ended June 30, 2024 as a result of the purchase of property and equipment.
Cash and cash equivalents
provided by financing activities were $154,437 for the six months ended June 30, 2024, as a result of the proceeds from stock options
exercises.
Use of Working
Capital
As of June 30,
2024, Cardiol’s working capital was $15,072,607 ($16,428,339 excluding the non-cash derivative liability). Based on current projections,
Cardiol believes that this amount is sufficient to fund operations and capital requirements, associated with achieving corporate milestones,
into 2026, as described in the “Outlook” section above.
The Corporation
has material commitments and obligations for cash resources set out below. The Corporation has no commitments for capital expenditures.
Contractual
Obligations | |
Total ($) | | |
Up
to 1 year ($) | | |
1
– 3 years ($) | | |
4
– 5 years ($) | | |
After
5 years ($) |
Amounts
payable and other liabilities | |
| 9,431,457 | | |
| 9,431,457 | | |
| Nil | | |
| Nil | | |
Nil |
Office
lease (1) | |
| 446,757 | | |
| 89,351 | | |
| 214,444 | | |
| 142,962 | | |
Nil |
Consulting
agreements | |
| 438,479 | | |
| 438,479 | | |
| Nil | | |
| Nil | | |
Nil |
Contract
research | |
| 1,493,420 | | |
| 695,329 | | |
| 798,091 | | |
| Nil | | |
Nil |
Total | |
| 11,810,113 | | |
| 10,654,616 | | |
| 1,012,535 | | |
| 142,962 | | |
Nil |
Note:
(1) The Corporation
has leased premises from third parties.
Related Party Transactions
| a) | The
Corporation entered into the following transactions with related parties: |
| i. | Included
in research and development expense is $109,129 and $737,809 for the three and six months
ended June 30, 2023 paid to a company, Dalton Chemical Laboratories, Inc. operating
as Dalton ("Dalton"), that was previously related to a Director (Peter Pekos).
As at December 31, 2023 - $416,792 was owed to this company and this amount was included
in accounts payable and accrued liabilities. Cardiol has an exclusive master services agreement
with Dalton for the manufacturing of its pharmaceutical cannabidiol. |
| b) | Key
Management personnel are those persons having authority and responsibility for planning,
directing, and controlling the activities of the Corporation directly or indirectly, including
any Directors (executive and non- executive) of the Corporation. Remuneration of Directors
and key Management personnel, except as noted in (a) above, was as follows: |
| |
Three
months ended June 30,
2024 | | |
Three
months ended June 30,
2023 | | |
Six
months ended June 30,
2024 | | |
Six
months ended June 30,
2023 | |
Salaries and benefits | |
$ | 540,335 | | |
$ | 534,446 | | |
$ | 1,804,739 | | |
$ | 1,704,476 | |
Share-based
payments | |
| 154,291 | | |
| 262,128 | | |
| 275,731 | | |
| 531,010 | |
| |
$ | 694,626 | | |
$ | 796,574 | | |
$ | 2,080,470 | | |
$ | 2,235,486 | |
As at June 30,
2024, $nil (December 31, 2023 - $nil) was owed to key Management personnel and this amount was included in accounts payable and
accrued liabilities.
Critical Accounting
Judgments, Estimates, and Assumptions
The preparation
of the Financial Statements requires Management to make certain estimates, judgments, and assumptions that affect the reported amounts
of assets and liabilities at the date of the Financial Statements and reported amounts of expenses during the reporting period. Actual
outcomes could differ from these estimates. The Financial Statements include estimates that, by their nature, are uncertain. The impacts
of such estimates are pervasive throughout the Financial Statements and may require accounting adjustments based on future occurrences.
Revisions to accounting estimates are recognized in the period in which the estimate is revised and future periods if the revision affects
both current and future periods. These estimates are based on historical experience, current and future economic conditions, and other
factors, including expectations of future events that are believed to be reasonable under the circumstances.
Critical accounting
estimates
Significant assumptions
about the future that Management has made that could result in a material adjustment to the carrying amounts of assets and liabilities,
in the event that actual results differ from assumptions made, relate to, but are not limited to, the following:
| · | The
valuation of performance share units; |
| · | The
valuation of the derivative liability; |
| · | The
estimate of the percentage of completion of certain research and development agreements; |
| · | The
valuation of the income tax non-current asset would increase if there was virtual certainty
that the tax benefit of net operating losses could be applied to future periods’ taxable
income; and |
| · | Intangible
assets are comprised of the exclusive global license. Intangible assets are initially stated
at cost, less accumulated amortization and accumulated impairment losses. Intangible assets
with finite useful lives are amortized over their estimated useful lives. The exclusive global
license’s useful life is nine years. |
Critical accounting
judgments
| · | Management
applied judgment in determining the functional currency of the Corporation as Canadian dollars; |
| · | Management
applied judgment in determining whether performance conditions on share-based awards were
market or non-market, and whether the fair value of the goods or services provided by certain
non-employees could be reliably measured; |
| · | Management
applied judgment in determining the Corporation’s ability to continue as a going concern.
The Corporation has incurred significant losses since its inception. Management determined
that a material going concern uncertainty does not exist due to the sufficient working capital
to support their planned expenditure levels. Future financing may come from product sales,
licensing arrangements, research and commercial development partnerships, government grants,
and/or corporate finance arrangements; and |
| · | Management’s
assessment that no impairment exists for intangible assets, based on the facts and circumstances
that existed during the period. |
Share Capital
Other than as described
below, as of the date of this MD&A, there are no equity or voting securities of the Corporation outstanding, and no securities convertible
into, or exercisable or exchangeable for, voting or equity securities of the Corporation.
As of the date
of this MD&A, the outstanding capital of the Corporation includes 69,881,720 issued and outstanding common shares; 1,020,000 Meros
Special Warrants convertible automatically into common shares (upon the Corporation achieving the Meros Milestone) for no additional
consideration pursuant to the Meros License Agreement; 400,000 common shares issuable to Dalton if Dalton meets certain performance objectives,
and stock options, warrants, performance share units, and restricted share units as shown below:
Stock Options
Expiry date | |
Exercise price
($) | | |
Options outstanding | | |
Options exercisable | |
February 23, 2025 | |
| 3.54 | | |
| 20,000 | | |
| 20,000 | |
August 19, 2025 | |
| 2.12 | | |
| 100,000 | | |
| 100,000 | |
August 30, 2025 | |
| 5.00 | | |
| 80,000 | | |
| 80,000 | |
April 1, 2026 | |
| 5.77 | | |
| 60,000 | | |
| 60,000 | |
September 10, 2026 | |
| 1.32 | (1) | |
| 25,000 | | |
| - | |
November 29, 2026 | |
| 2.38 | | |
| 250,000 | | |
| - | |
December 8, 2026 | |
| 3.59 | | |
| 325,000 | | |
| 216,667 | |
January 11, 2027 | |
| 2.18 | | |
| 220,000 | | |
| 146,667 | |
March 1, 2027 | |
| 2.56 | | |
| 350,000 | | |
| 87,500 | |
March 14, 2027 | |
| 2.07 | | |
| 60,000 | | |
| 40,000 | |
May 12, 2027 | |
| 1.46 | | |
| 70,000 | | |
| 46,667 | |
September 12, 2027 | |
| 1.61 | | |
| 207,500 | | |
| 69,168 | |
Total | |
| | | |
| 1,767,500 | | |
| 866,669 | |
(1) Exercise price denoted
in USD.
Warrants
Expiry
date | |
Exercise
price ($) | | |
Warrants
outstanding | |
November 5,
2024 | |
| 5.13 | (1) | |
| 8,175,000 | |
(1) Exercise price denoted
in USD.
Performance Share Units
The Corporation has 350,000 outstanding
performance share units ("PSUs") subject to vesting conditions specific to each grant.
Restricted Share Units
The Corporation
has 5,466,446 outstanding restricted share units ("RSUs") subject to vesting conditions specific to each grant. Of the outstanding
RSUs, 2,507,034 have fully vested as of the date of this MD&A.
Financial Instruments
Recognition
The Corporation
recognizes a financial asset or financial liability on the statement of financial position when it becomes party to the contractual provisions
of the financial instrument. Financial assets are initially measured at fair value and are derecognized either when the Corporation has
transferred substantially all the risks and rewards of ownership of the financial asset, or when cash flows expire. Financial liabilities
are initially measured at fair value and are derecognized when the obligation specified in the contract is discharged, cancelled, or
has expired.
A write-off of
a financial asset (or a portion thereof) constitutes a derecognition event. A write-off occurs when the Corporation has no reasonable
expectations of recovering the contractual cash flows on a financial asset.
Classification
and Measurement
The Corporation
determines the classification of its financial instruments at initial recognition. Financial assets and financial liabilities are classified
according to the following measurement categories:
| · | those
to be measured subsequently at fair value, either through profit or loss (“FVTPL”)
or through other comprehensive income (“FVTOCI”); and, |
| · | those
to be measured subsequently at amortized cost. |
The classification
and measurement of financial assets after initial recognition at fair value depends on the business model for managing the financial
asset and the contractual terms of the cash flows. Financial assets that are held within a business model whose objective is to collect
the contractual cash flows, and that have contractual cash flows that are solely payments of principal and interest on the principal
outstanding, are generally measured at amortized cost at each subsequent reporting period. All other financial assets are measured at
their fair values at each subsequent reporting period, with any changes recorded through profit or loss or through other comprehensive
income (which designation is made as an irrevocable election at the time of recognition).
After initial recognition
at fair value, financial liabilities are classified and measured at either:
| · | FVTPL,
if the Corporation has made an irrevocable election at the time of recognition, or when required
(for items such as instruments held for trading or derivatives); or, |
| · | FVTOCI,
when the change in fair value is attributable to changes in the Corporation’s credit
risk. |
The Corporation
reclassifies financial assets when and only when its business model for managing those assets changes. Financial liabilities are not
reclassified.
Transaction costs
that are directly attributable to the acquisition or issuance of a financial asset or financial liability classified as subsequently
measured at amortized cost are included in the fair value of the instrument on initial recognition. Transaction costs for financial assets
and financial liabilities classified at fair value through profit or loss are expensed in profit or loss.
The Corporation’s
financial assets consist of cash and cash equivalents and accounts receivable, which are classified and measured at amortized cost. The
Corporation’s financial liabilities consist of accounts payable and accrued liabilities, and lease liability, which are classified
and measured at amortized cost, and derivative liabilities which are classified and measured at FVTPL.
Fair Value
The Corporation
provides information about its financial instruments measured at fair value at one of three levels according to the relative reliability
of the inputs used to estimate the fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets
for identical assets or liabilities and the lowest priority to unobservable inputs. The three levels of the fair value hierarchy are
as follows:
| · | Level
1: |
quoted
prices (unadjusted) in active markets for identical assets or liabilities; |
| · | Level
2: |
inputs
other than quotes prices included in Level 1 that are observable for the asset or liability,
either directly (i.e., as prices) or indirectly (i.e., derived from prices); and |
| · | Level
3: |
inputs
for the asset or liability that are not based on observable market data (unobservable inputs). |
The Corporation's
derivative liabilities are measured at fair value Level 3. No other financial instruments are measured at fair value.
Financial Instrument
Risks
The Corporation’s
activities expose it to a variety of financial risks: credit risk, liquidity risk, and market risk (including interest rate and foreign
currency risk). These financial risks are in addition to the risks set out under “Risk Factors”.
Risk management
is carried out by the Corporation’s Management team under policies approved by the Board of Directors. The Board of Directors also
provides regular guidance for overall risk management.
There were no changes
to credit risk, liquidity risk, or market risk for the 2024 Fiscal Period.
Credit risk
Credit risk is
the risk that one party to a financial instrument will cause a financial loss for the other party by failing to discharge an obligation.
The Corporation’s financial instruments that are exposed to concentrations of credit risk relate primarily to cash and cash equivalents
and accounts receivable.
The Corporation
mitigates its risk by maintaining its funds with large reputable financial institutions, from which Management believes the risk of loss
to be minimal. Interest receivable relates to guaranteed investment certificates and cash balances held with large reputable financial
institutions as well as receivables. The Corporation’s Management considers that all the above financial assets are of good credit
quality.
Liquidity risk
Liquidity risk
is the risk that the Corporation encounters difficulty in meeting its obligations associated with financial liabilities. Liquidity risk
includes the risk that, as a result of operational liquidity requirements, the Corporation will not have sufficient funds to settle a
transaction on the due date; will be forced to sell financial assets at a value which is less than what they are worth; or may be unable
to settle or recover a financial asset. Liquidity risk arises from accounts payable and accrued liabilities and commitments. The Corporation
limits its exposure to this risk by closely monitoring its cash flow.
Market risk
Market risk is
the risk of loss that may arise from changes in market factors, such as interest rates and foreign exchange rates.
The Corporation
currently does not have any short-term or long-term debt that is variable interest bearing and, as such, the Corporation’s current
exposure to interest rate risk is minimal.
Foreign exchange
risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in the foreign
exchange rates. The Corporation enters into foreign currency purchase transactions and has assets that are denominated in foreign currencies
and thus is exposed to the financial risk of earnings fluctuations arising from changes in foreign exchange rates and the degree of volatility
of these rates. The Corporation does not currently use derivative instruments to reduce its exposure to foreign currency risk.
The Corporation
holds balances in U.S. dollars which could give rise to exposure to foreign exchange risk. Sensitivity to a plus or minus 10% change
in the foreign exchange rate of the U.S. dollar against the Canadian dollar would affect the reported loss and comprehensive loss by
approximately $1,302,000 (December 31, 2023 - $2,770,000).
Commitments
and Contingency
(i) The
Corporation has leased premises from third parties. The minimum committed lease payments as at June 30, 2024, which include the
lease liability payments, are as follows:
Fiscal
year | |
| |
2024 | |
$ | 35,741 | |
2025 | |
| 107,222 | |
2026 | |
| 107,222 | |
2027 | |
| 107,222 | |
2028 | |
| 89,351 | |
Total | |
$ | 446,758 | |
(ii) The
Corporation has signed various agreements with consultants to provide services. Under the agreements, the Corporation has the following
remaining commitments.
Fiscal
year | |
| |
2024 | |
$ | 438,479 | |
Total | |
$ | 438,479 | |
(iii) Pursuant
to the terms of agreements with various other contract research organizations, the Corporation is committed for the following contract
research services:
Fiscal
year | |
| |
2024 | |
$ | 303,888 | |
2025 | |
| 1,176,824 | |
2026 | |
| 12,708 | |
Total | |
$ | 1,493,420 | |
Breakdown of
Expensed Research and Development
| |
Three months
ended | | |
Three months
ended | | |
Six months
ended | | |
Six months
ended | |
| |
June 30,
2024 | | |
June 30,
2023 | | |
June 30,
2024 | | |
June 30,
2023 | |
Contract research | |
$ | 2,145,786 | | |
$ | 2,411,248 | | |
$ | 4,584,324 | | |
$ | 5,652,886 | |
Wages | |
| 391,755 | | |
| 332,281 | | |
| 1,039,593 | | |
| 976,007 | |
Supplies | |
| 913 | | |
| 530,101 | | |
| 3,612 | | |
| 534,172 | |
Regulatory | |
| 144,961 | | |
| 107,268 | | |
| 325,471 | | |
| 248,124 | |
Share-based
compensation | |
| 26,229 | | |
| 98,487 | | |
| 79,573 | | |
| 195,892 | |
| |
$ | 2,709,644 | | |
$ | 3,479,385 | | |
$ | 6,032,573 | | |
$ | 7,607,081 | |
Breakdown of Intangible Assets
| |
As
at
June 30, 2024 | | |
As
at
December 31, 2023 | |
Exclusive global
license agreement | |
$ | 767,228 | | |
$ | 767,228 | |
Accumulated
amortization | |
| (599,092 | ) | |
| (556,870 | ) |
Carrying value | |
$ | 168,136 | | |
$ | 210,358 | |
Internal Controls
Over Financial Reporting
In accordance with
National Instrument 52-109 – Certification of Disclosure in Issuers’ Annual and Interim Filings, Management is responsible
for establishing and maintaining adequate Disclosure Controls and Procedures (“DCP”) and Internal Control Over Financial
Reporting (“ICFR”). Management has designed DCP and ICFR based on the 2013 Internal Control Integrated Framework issued by
the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”), with the objective of providing reasonable
assurance that the Corporation’s financial reports and information, including the Corporation’s Financial Statements and
MD&A were prepared in accordance with IFRS. The CEO and CFO have concluded that the DCP and ICFR were adequately designed and operating
effectively to provide such assurance as at June 30, 2024.
Limitations
of Controls and Procedures
The Corporation’s
Management, including the CEO and CFO, believes that any DCP or ICFR, no matter how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact
that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent
limitations in all control systems, they cannot provide absolute assurance that all control issues and instances of fraud, if any, within
the Corporation have been prevented or detected. These inherent limitations include the realities that judgments in decision-making can
be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by unauthorized override of the control. The design of any control system
is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions. Accordingly, because of the inherent limitations in a cost-effective
control system, misstatements due to error or fraud may occur and not be detected.
There have been
no changes in internal controls over financial reporting for the quarter ended June 30, 2024, that have materially affected, or
are reasonably likely to materially affect, the Corporation’s ICFR.
Risk Factors
An investment in
the securities of the Corporation is highly speculative and involves numerous and significant risks. Such investment should be undertaken
only by investors whose financial resources are sufficient to enable them to assume these risks. Prospective investors should carefully
consider the risk factors that have affected, and which in the future are reasonably expected to affect, the Corporation and its financial
position. Please refer to the section entitled "Risk Factors" in the Corporation's MD&A for the financial year ended December 31,
2023 (available on SEDAR+ at sepdarplus.ca and EDGAR at www.sec.gov).
References
1.
Bragazzi NL, Zhong W, Shu J, et al. Burden of heart failure and underlying causes in 195 countries and territories from 1990 to
2017. Eur J Prev Cardiol. 2021;28(15):1682-1690. doi:10.1093/eurjpc/zwaa147
Tsao
CW et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee.
Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation. 2023 Jan 25.
2.
Adler Y, Charron P. The 2015 ESC Guidelines on the diagnosis and management of pericardial diseases. Eur Heart J. 2015;36(42):2873-2874.
doi:10.1093/eurheartj/ehv479
Chiabrando
JG, Bonaventura A, Vecchié A, et al. Management of Acute and Recurrent Pericarditis: JACC State-of-the- Art Review. J
Am Coll Cardiol. 2020;75(1):76-92. doi:10.1016/j.jacc.2019.11.021
Lin
D, Laliberté F, Majeski C, et al. Disease and economic burden associated with recurrent pericarditis in a privately insured
United States population. Adv Ther . 2021;38(10):5127.
Luis
SA, LeWinter MM, Magestro M, et al. Estimating the US pericarditis prevalence using national health encounter surveillance databases.
Curr Med Res Opin. 2022;38(8):1385-1389. doi:10.1080/03007995.2022.2070381
Klein
A, Cremer P, Kontzias A, et al. US Database Study of Clinical Burden and Unmet Need in Recurrent Pericarditis. J Am Heart Assoc.
2021;10(15):e018950. doi:10.1161/JAHA.120.018950
Imazio
M, Brucato A, Adler Y. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2014;370(8):781. doi:10.1056/NEJMc1315351
Tingle LE, Molina
D, Calvert CW. Acute pericarditis. Am Fam Physician. 2007;76(10):1509-1514.
Kytö
V, Sipilä J, Rautava P. Clinical profile and influences on outcomes in patients hospitalized for acute pericarditis. Circulation.
2014;130(18):1601-1606. doi:10.1161/CIRCULATIONAHA.114.010376
Mody
P, Bikdeli B, Wang Y, Imazio M, Krumholz HM. Trends in acute pericarditis hospitalizations and outcomes among the elderly in the
USA, 1999-2012. Eur Heart J Qual Care Clin Outcomes. 2018;4(2):98-105. doi:10.1093/ehjqcco/qcx040
3.
Ammirati E, Cipriani M, Moro C, et al. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis:
Multicenter Lombardy Registry. Circulation. 2018;138(11):1088-1099. doi:10.1161/CIRCULATIONAHA.118.035319
Ammirati
E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023;329(13):1098-1113. doi:10.1001/jama.2023.3371
Basso C. Myocarditis. N Engl J Med.
2022; 387(16):1488-1500. doi:10.1056/NEJMra2114478
Bemtgen
X, Kaier K, Rilinger J, et al. Myocarditis mortality with and without COVID-19: insights from a national registry. Clin Res
Cardiol. 2024;113(2):216-222. doi:10.1007/s00392-022-02141-9
Khorolsky,
C, Shi, J, Chkhikvadze, T. TRENDS IN HOSPITALIZATION COSTS, LENGTH OF STAY AND COMPLICATIONS AMONG PATIENTS WITH ACUTE MYOCARDITIS: A
10-YEAR UNITED STATES PERSPECTIVE. J Am Coll Cardiol. 2019 Mar, 73 (9_Supplement_1) 935.
Lynge
TH, Nielsen TS, Gregers Winkel B, Tfelt-Hansen J, Banner J. Sudden cardiac death caused by myocarditis in persons aged 1-49 years: a
nationwide study of 14?294 deaths in Denmark. Forensic Sci Res. 2019;4(3):247- 256. Published 2019 Aug 19. doi:10.1080/20961790.2019.1595352
Tschöpe
C, Ammirati E, Bozkurt B, et al. Myocarditis and inflammatory cardiomyopathy: current evidence and future directions. Nat Rev
Cardiol. 2021;18(3):169-193. doi:10.1038/s41569-020-00435-x
Wang
X, Bu X, Wei L, Liu J, Yang D, Mann DL, Ma A and Hayashi T (2021) Global, Regional, and National Burden of Myocarditis From 1990 to 2017:
A Systematic Analysis Based on the Global Burden of Disease Study 2017. Front. Cardiovasc. Med. 8:692990. doi: 10.3389/fcvm.2021.692990
Exhibit 99.3
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, David Elsley, President and Chief Executive Officer of Cardiol
Therapeutics Inc., certify the following:
| 1. | Review: I have reviewed the interim financial report and
interim MD&A (together, the “interim filings”) of Cardiol Therapeutics
Inc. (the “issuer”) for the interim period ended June 30, 2024. |
| 2. | No misrepresentations: Based on my knowledge, having exercised
reasonable diligence, the interim filings do not contain any untrue statement of a material
fact or omit to state a material fact required to be stated or that is necessary to make
a statement not misleading in light of the circumstances under which it was made, with respect
to the period covered by the interim filings. |
| 3. | Fair presentation: Based on my knowledge, having exercised
reasonable diligence, the interim financial report together with the other financial information
included in the interim filings fairly present in all material respects the financial condition,
financial performance and cash flows of the issuer, as of the date of and for the periods
presented in the interim filings. |
| 4. | Responsibility: The issuer’s other certifying officer(s) and
I are responsible for establishing and maintaining disclosure controls and procedures (DC&P)
and internal control over financial reporting (ICFR), as those terms are defined in National
Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings,
for the issuer. |
| 5. | Design: Subject to the limitations, if any, described in
paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as
at the end of the period covered by the interim filings |
| (a) | designed DC&P, or caused it to be designed under our supervision,
to provide reasonable assurance that |
| (i) | material information relating to the issuer is made known to us by
others, particularly during the period in which the interim filings are being prepared; and |
| (ii) | information required to be disclosed by the issuer in its annual
filings, interim filings or other reports filed or submitted by it under securities legislation
is recorded, processed, summarized and reported within the time periods specified in securities
legislation; and |
| (b) | designed ICFR, or caused it to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with the issuer’s
GAAP. |
| 5.1 | Control framework: The control framework the issuer’s
other certifying officer(s) and I used to design the issuer’s ICFR is 2013 Internal
Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (“COSO”). |
| 6. | Reporting changes in ICFR: The issuer has disclosed in its
interim MD&A any change in the issuer’s ICFR that occurred during the period beginning
April 1, 2024 and ended on June 30, 2024 that has materially affected, or is reasonably
likely to materially affect, the issuer’s ICFR. |
|
|
Date: August 12, 2024 |
|
|
|
“David
Elsley” |
|
David Elsley |
|
President and Chief Executive Officer |
|
Exhibit 99.4
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Chris Waddick, Chief Financial Officer of Cardiol Therapeutics
Inc., certify the following:
1. |
Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Cardiol Therapeutics Inc. (the “issuer”) for the interim period ended June 30, 2024. |
2. |
No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
3. |
Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
4. |
Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer. |
5. |
Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings |
|
(a) |
designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
|
(i) |
material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
|
(ii) |
information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
|
(b) |
designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
5.1 |
Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is 2013 Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). |
6. |
Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning April 1, 2024 and ended on June 30, 2024 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR. |
Date: August 12,
2024 |
|
|
|
“Chris Waddick” |
|
Chris Waddick |
|
Chief Financial Officer |
|
Cardiol Therapeutics (NASDAQ:CRDL)
Historical Stock Chart
From Nov 2024 to Dec 2024
Cardiol Therapeutics (NASDAQ:CRDL)
Historical Stock Chart
From Dec 2023 to Dec 2024