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 May 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: May 14, 2024 |
By: |
/s/ Chris Waddick |
|
|
Name: |
Chris Waddick |
|
|
Title: |
Chief Financial Officer |
Exhibit
99.1
CARDIOL THERAPEUTICS
INC.
CONDENSED INTERIM
CONSOLIDATED
FINANCIAL STATEMENTS
THREE MONTHS
ENDED MARCH 31, 2024
(EXPRESSED IN
CANADIAN DOLLARS)
(UNAUDITED)
Cardiol
Therapeutics Inc. Condensed Interim Consolidated
Statements of Financial Position
(Expressed in Canadian Dollars)
Unaudited |
|
| |
As at
March 31, | | |
As at December 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | |
| |
| |
| | |
| |
Current assets | |
| | | |
| | |
Cash and cash equivalents
(note 3) | |
$ | 28,572,975 | | |
$ | 34,931,778 | |
Accounts receivable | |
| 153,975 | | |
| 142,745 | |
Other receivables | |
| 163,131 | | |
| 137,127 | |
Prepaid expenses | |
| 1,746,946 | | |
| 941,442 | |
Total current assets | |
| 30,637,027 | | |
| 36,153,092 | |
| |
| | | |
| | |
Non-current assets | |
| | | |
| | |
Property and equipment (note 4) | |
| 300,006 | | |
| 337,058 | |
Intangible assets
(note 5) | |
| 189,247 | | |
| 210,358 | |
Total assets | |
$ | 31,126,280 | | |
$ | 36,700,508 | |
| |
| | | |
| | |
EQUITY AND LIABILITIES | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities
(note 14) | |
$ | 8,853,193 | | |
$ | 8,041,485 | |
Current portion of lease liability
(note 6) | |
| 16,476 | | |
| 15,808 | |
Derivative liability
(note 7) | |
| 2,046,779 | | |
| 238,176 | |
Total current liabilities | |
| 10,916,448 | | |
| 8,295,469 | |
| |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Lease liability
(note 6) | |
| 150,660 | | |
| 158,532 | |
Total liabilities | |
| 11,067,108 | | |
| 8,454,001 | |
| |
| | | |
| | |
Equity | |
| | | |
| | |
Share capital (note 8) | |
| 151,091,556 | | |
| 148,519,136 | |
Warrants (note 10) | |
| 3,517,867 | | |
| 3,517,867 | |
Contributed surplus | |
| 17,206,183 | | |
| 18,786,306 | |
Deficit | |
| (151,756,434 | ) | |
| (142,576,802 | ) |
Total equity | |
| 20,059,172 | | |
| 28,246,507 | |
Total equity and liabilities | |
$ | 31,126,280 | | |
$ | 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 | | |
Three Months | |
| |
Ended | | |
Ended | |
| |
March 31, | | |
March 31, | |
| |
2024 | | |
2023 | |
Operating expenses (notes
9, 13, 14) | |
| | | |
| | |
General and administration | |
| 5,082,552 | | |
| 3,658,440 | |
Research and development | |
| 3,322,929 | | |
| 4,127,696 | |
Loss before other income | |
| (8,405,481 | ) | |
| (7,786,136 | ) |
Interest income | |
| 377,294 | | |
| 545,927 | |
Gain on foreign exchange | |
| 628,935 | | |
| 76,792 | |
Change in derivative liability (note
7) | |
| (1,808,603 | ) | |
| 74,081 | |
Other income | |
| 28,223 | | |
| - | |
Net loss and comprehensive loss
for the period | |
$ | (9,179,632 | ) | |
$ | (7,089,336 | ) |
| |
| | | |
| | |
Basic and diluted net loss
per share (note 11) | |
$ | (0.14 | ) | |
$ | (0.11 | ) |
Weighted average number of common shares outstanding | |
| 67,259,344 | | |
| 64,091,647 | |
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 |
|
| |
Three Months | | |
Three Months | |
| |
Ended | | |
Ended | |
| |
March 31, | | |
March 31, | |
| |
2024 | | |
2023 | |
Operating activities | |
| | | |
| | |
Net loss and comprehensive loss for the period | |
$ | (9,179,632 | ) | |
$ | (7,089,336 | ) |
Adjustments for: | |
| | | |
| | |
Depreciation of property and equipment | |
| 40,512 | | |
| 37,094 | |
Amortization of intangible assets | |
| 21,111 | | |
| 21,111 | |
Share-based compensation | |
| 902,100 | | |
| 426,823 | |
Change in derivative liability | |
| 1,808,603 | | |
| (74,081 | ) |
Unrealized foreign exchange gain on
cash | |
| (491,097 | ) | |
| (2,760 | ) |
Accretion on lease liability | |
| 6,640 | | |
| 1,635 | |
Shares for services | |
| - | | |
| 16,449 | |
Changes in non-cash
working capital items: | |
| | | |
| | |
Accounts receivable | |
| (11,230 | ) | |
| 12,097 | |
Other receivables | |
| (26,004 | ) | |
| 59,937 | |
Prepaid expenses | |
| (805,504 | ) | |
| (744,856 | ) |
Accounts payable
and accrued liabilities | |
| 811,708 | | |
| (2,610,896 | ) |
Net cash used in operating activities | |
| (6,922,793 | ) | |
| (9,946,783 | ) |
| |
| | | |
| | |
Investing activities | |
| | | |
| | |
Purchase of property and equipment | |
| (3,460 | ) | |
| (44,138 | ) |
Net cash used in investing activities | |
| (3,460 | ) | |
| (44,138 | ) |
| |
| | | |
| | |
Financing activities | |
| | | |
| | |
Proceeds from stock options exercised | |
| 90,197 | | |
| - | |
Payment of lease liability | |
| (13,844 | ) | |
| (13,844 | ) |
Net cash provided by (used in) financing
activities | |
| 76,353 | | |
| (13,844 | ) |
Net change in cash and cash equivalents | |
| (6,849,900 | ) | |
| (10,004,765 | ) |
Cash and cash equivalents, beginning of period | |
| 34,931,778 | | |
| 59,469,868 | |
Impact of foreign exchange on cash
and cash equivalents | |
| 491,097 | | |
| 2,760 | |
Cash and cash equivalents, end
of period | |
$ | 28,572,975 | | |
$ | 49,467,863 | |
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 | |
| 50,000 | |
| 70,500 | |
| - | |
| (70,500 | ) |
| - | |
| - | |
Shares for services | |
| 5,000 | |
| 16,449 | |
| - | |
| - | |
| - | |
| 16,449 | |
Share-based
compensation (note 9) | |
| - | |
| - | |
| - | |
| 426,823 | |
| - | |
| 426,823 | |
Net
loss and comprehensive loss for the period | |
| - | |
| - | |
| - | |
| - | |
| (7,089,336 | ) |
| (7,089,336 | ) |
Balance, March 31,
2023 | |
| 64,097,536 | |
$ | 147,632,348 | |
$ | 3,517,867 | |
$ | 15,943,155 | |
$ | (121,537,846 | ) |
$ | 45,555,524 | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
Balance, December 31, 2023 | |
| 65,352,279 | |
$ | 148,519,136 | |
$ | 3,517,867 | |
$ | 18,786,306 | |
$ | (142,576,802 | ) |
$ | 28,246,507 | |
Restricted
share units exercised | |
| 1,531,429 | |
| 1,830,736 | |
| - | |
| (1,830,736 | ) |
| - | |
| - | |
Stock
options exercised | |
| 100,000 | |
| 90,197 | |
| - | |
| - | |
| - | |
| 90,197 | |
Fair value
of stock options exercised | |
| - | |
| 46,905 | |
| - | |
| (46,905 | ) |
| - | |
| - | |
Share-based
compensation (note 9) | |
| - | |
| - | |
| - | |
| 902,100 | |
| - | |
| 902,100 | |
Performance
share units exercised | |
| 1,300,000 | |
| 604,582 | |
| - | |
| (604,582 | ) |
| - | |
| - | |
Net
loss and comprehensive loss for the period | |
| - | |
| - | |
| - | |
| - | |
| (9,179,632 | ) |
| (9,179,632 | ) |
Balance, March 31,
2024 | |
| 68,283,708 | |
$ | 151,091,556 | |
$ | 3,517,867 | |
$ | 17,206,183 | |
$ | (151,756,434 | ) |
$ | 20,059,172 | |
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 Months Ended March 31,
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 small molecule 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", and on May 12, 2021, warrants commenced
trading under the symbol "CRDL.WT.A" (delisted on expiry subsequent to March 31, 2024). 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 May 14, 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 months ended March 31, 2024 amounted to $377,294 (three months ended March 31, 2023
- $545,927).
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
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 | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,460 | | |
| 3,460 | |
Balance, March 31, 2024 | |
$ | 341,238 | | |
$ | 219,809 | | |
$ | 237,248 | | |
$ | 66,864 | | |
$ | 132,117 | | |
$ | 997,276 | |
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 | |
| 15,996 | | |
| 6,607 | | |
| 12,710 | | |
| 1,325 | | |
| 3,874 | | |
| 40,512 | |
Balance, March 31, 2024 | |
$ | 212,664 | | |
$ | 138,329 | | |
$ | 220,262 | | |
$ | 41,680 | | |
$ | 84,335 | | |
$ | 697,270 | |
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, March 31, 2024 | |
$ | 128,574 | | |
$ | 81,480 | | |
$ | 16,986 | | |
$ | 25,184 | | |
$ | 47,782 | | |
$ | 300,006 | |
| |
Exclusive
global |
|
Cost | |
license
agreement |
|
Balance,
December 31, 2022, December 31, 2023, and March 31, 2024 | |
$ |
767,228 |
|
| |
Exclusive global | |
Accumulated Amortization | |
license agreement | |
Balance, December 31, 2022 | |
$ | 472,426 | |
Amortization for the year | |
| 84,444 | |
Balance, December 31, 2023 | |
$ | 556,870 | |
Amortization for the period | |
| 21,111 | |
Balance, March 31, 2024 | |
$ | 577,981 | |
| |
Exclusive global | |
Carrying
Value | |
license agreement | |
Balance, December 31,
2023 | |
$ | 210,358 | |
Balance, March 31,
2024 | |
$ | 189,247 | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
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 March 31,
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 Months Ended March 31,
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 | |
| (13,844 | ) |
Accretion | |
| 6,640 | |
Balance, March 31, 2024 | |
$ | 167,136 | |
Current portion | |
| 16,476 | |
Long-term portion | |
$ | 150,660 | |
(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 March 31, 2024, the fair
value of the derivative liability was $2,046,779 (December 31, 2023 - $238,176), resulting in an increase in the value of the derivative
liability for the three months ended March 31, 2024 of $1,808,603 (three months ended March 31, 2023 - decrease in fair value
of $74,081).
Significant assumptions
used in determining the fair value of the derivative warrant liabilities are as follows:
| |
Three Months
Ended | | |
Three Months
Ended | |
| |
March 31, | | |
March 31, | |
| |
2024 | | |
2023 | |
Share price | |
USD$ |
1.81 | | |
USD$ |
0.49 | |
Exercise price | |
USD$ |
3.75 | | |
USD$ |
3.75 | |
Risk-free interest rate | |
4.20 | % | |
| 3.74 | % |
Expected volatility | |
99 | % | |
| 97 | % |
Expected life in years | |
0.60 | | |
| 1.60 | |
Expected dividend yield | |
Nil | | |
| Nil | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
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) | |
50,000 | |
| 70,500 | |
Balance, March 31, 2023 | |
64,097,536 | |
$ | 147,632,348 | |
Balance, December 31, 2023 | |
65,352,279 | |
$ | 148,519,136 | |
Restricted share units exercised (note
9) | |
1,531,429 | |
| 1,830,736 | |
Stock options exercised (note 9) | |
100,000 | |
| 90,197 | |
Fair value of stock options exercised
(note 9) | |
- | |
| 46,905 | |
Performance share
units exercised (note 9) | |
1,300,000 | |
| 604,582 | |
Balance, March 31, 2024 | |
68,283,708 | |
$ | 151,091,556 | |
(i) During
the three months ended March 31, 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.
c) 2022 At-The-Market ("ATM")
Program
In
June 2022, the Corporation announced it entered into an equity distribution agreement with Canaccord Genuity LLC and Cantor
Fitzgerald & Co. (the "Sales Agents") acting as co-agents in connection with the 2022 at-the-market offering
program (the "2022 ATM Program"). Under the terms of the 2022 ATM Program, the Corporation could, from time to time, sell
common shares having an aggregate value of USD$50,000,000 through the Sales Agents on the Nasdaq Capital Market. As at
March 31, 2024, the 2022 ATM Program has expired with no shares having been issued under it.
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.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
2024
(Expressed in Canadian Dollars)
Unaudited
| 9. | Share-based
payments (continued) |
During the three
months ended March 31, 2024, the total expenses related to share-based compensation amounted to $902,100 (three months ended March 31,
2023 - $426,823). All outstanding awards are settleable with common shares and not cash.
(a) Stock
Options
| |
Number of | |
Weighted average | |
| |
stock options | |
exercise
price ($) | |
Balance, December 31, 2022 | |
1,968,476 | |
$ | 3.52 | |
Expired | |
(775,976 | ) |
| 4.65 | |
Balance, March 31, 2023 | |
1,192,500 | |
$ | 2.79 | |
Balance, December 31, 2023 | |
1,732,500 | |
$ | 2.44 | |
Issued | |
455,000 | |
| 2.56 | |
Expired | |
(110,000 | ) |
| 1.36 | |
Exercised (i) | |
(100,000 | ) |
| 1.92 | |
Balance, March 31, 2024 | |
1,977,500 | |
$ | 2.61 | |
(i) The weighted average share price on
date of exercise was $2.22.
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:
| |
Three Months | |
| |
Ended | |
| |
March 31, | |
| |
2024 | |
Fair value of stock options at grant date | |
$ | 1.89 | |
Share price | |
$ | 2.83 | |
Exercise price | |
$ | 2.56 | |
Risk-free interest rate | |
| 3.83 | % |
Expected volatility | |
| 93 | % |
Expected life in years | |
| 3.13 | |
Expected dividend yield | |
| Nil | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
2024
(Expressed in Canadian Dollars)
Unaudited
| 9. | Share-based
payments (continued) |
The following table reflects the actual
stock options issued and outstanding as of March 31, 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 | |
0.90 | |
20,000 | |
20,000 | |
April 10,
2025 | |
0.75 | |
1.03 | |
25,000 | |
- | |
August 19,
2025 | |
2.12 | |
1.39 | |
100,000 | |
100,000 | |
August 30,
2025 | |
5.00 | |
1.42 | |
80,000 | |
80,000 | |
April 1,
2026 | |
5.77 | |
2.00 | |
60,000 | |
60,000 | |
September 10,
2026 | |
1.32 | |
2.45 | |
75,000 | |
25,000 | |
November 29,
2026 | |
2.38 | |
2.67 | |
250,000 | |
- | |
December 8,
2026 | |
3.59 | |
2.69 | |
325,000 | |
216,667 | |
January 11,
2027 | |
2.18 | |
2.78 | |
220,000 | |
146,667 | |
March 1,
2027(i) | |
2.56 | |
2.92 | |
425,000 | |
- | |
March 14,
2027 | |
2.07 | |
2.95 | |
60,000 | |
40,000 | |
May 12,
2027 | |
1.46 | |
3.12 | |
70,000 | |
23,334 | |
September 12,
2027 | |
1.61 | |
3.45 | |
207,500 | |
69,168 | |
October 23,
2028 | |
1.20 | |
4.57 | |
30,000 | |
- | |
January 29,
2029 | |
2.56 | |
4.84 | |
30,000 | |
- | |
| |
2.61 | |
2.72 | |
1,977,500 | |
780,836 | |
(i) Subsequent
to March 31, 2024, 75,000 unexercised options expired.
(b) Performance
Share Units
The Corporation
has 700,000 outstanding PSUs as at March 31, 2024 (March 31, 2023 - 600,000, December 31, 2023 - 2,000,000). Grants of
PSUs require completion of certain performance criteria specific to each grant. These PSUs have an expiry date of December 31, 2024.
As at March 31, 2024, nil PSUs were vested (exercisable).
During the three
months ended March 31, 2024, 1,300,000 PSUs vested and were exercised by certain consultants of the Corporation for a total value
of $604,582 (March 31, 2023 - nil PSUs vested and were redeemed for a total value of $nil). During the three months ended March 31,
2024, the weighted average share price on date of exercise was $1.54. Subsequent to March 31, 2024, 600,000 PSUs vested and were
exercised.
(c) Restricted
Share Units
The total outstanding
RSUs at March 31, 2024 is 2,013,458 (March 31, 2023 - 2,262,963, December 31, 2023 - 3,544,887). Of the outstanding RSUs,
1,551,546 have fully vested as of March 31, 2024.
During the three
months ended March 31, 2024, the Corporation granted nil RSUs. During the three months ended March 31, 2024, 1,531,429 RSUs
were redeemed (March 31, 2023 - nil) and nil unvested RSUs expired. During the three months ended March 31, 2024, the weighted
average share price on date of exercise was $1.53. Subsequent to March 31, 2024, 64,605 RSUs were redeemed.
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
2024
(Expressed in Canadian Dollars)
Unaudited
| | |
Number of | | |
| |
| | |
warrants | | |
Amount | |
Balance, December 31, 2022 and March 31,
2023 | | |
| 11,628,178 | | |
$ | 3,517,867 | |
Balance, December 31, 2023 and March 31, 2024 | | |
| 11,628,178 | | |
$ | 3,517,867 | |
The following table
reflects the actual warrants issued and outstanding as of March 31, 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):
Expiry date | |
Exercise
price ($) | | |
Remaining
contractual
life (years) | | |
Warrants
exercisable | |
May 12, 2024(2) | |
4.60 | | |
0.12 | | |
3,453,178 | |
November 5, 2024(1) | |
5.08 | | |
0.60 | | |
8,175,000 | |
| |
4.94 | | |
0.46 | | |
11,628,178 | |
(1) Warrants carry an exercise price
of USD$3.75. This amount was translated to CAD for presentation purposes at the March 31, 2024 rate of 1.35. These warrants are
classified as a derivative liability on the statement of financial position (see note 7).
(2) Subsequent
to March 31, 2024, 3,453,178 warrants expired unexercised.
For the three months
ended March 31, 2024, basic and diluted loss per share has been calculated based on the loss attributable to common shareholders
of $9,179,632 (three months ended March 31, 2023 - $7,089,336) and the weighted average number of common shares outstanding of 67,259,344
(three months ended March 31, 2023 - 64,091,647). 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 | | |
$ | 27,688 | | |
$ | 25,923 | | |
$ | 53,611 | |
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 | |
| | |
$ | 239,962 | | |
$ | 224,666 | | |
$ | 464,628 | |
Cardiol Therapeutics Inc.
Notes to Condensed Interim Consolidated
Financial Statements
Three Months Ended March 31,
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 | |
$ | 458,176 | |
2025 | |
| 1,109,206 | |
2026 | |
| 12,708 | |
Total | |
$ | 1,580,090 | |
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 March 31, 2024 | | |
Three
Months Ended March 31, 2023 | |
Research and development expenses | |
| | |
| |
Non-cash share-based compensation | |
53,344 | | |
97,405 | |
| |
| | |
| |
General and administration expenses | |
| | |
| |
Depreciation of property and equipment | |
40,512 | | |
37,094 | |
Amortization of intangible assets | |
21,111 | | |
21,111 | |
Non-cash share-based compensation | |
848,756 | | |
329,418 | |
| 14. | Related
party transactions |
(a) The Corporation
entered into the following transactions with related parties:
(i) Included
in research and development expense is $628,680 for the three months ended March 31, 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 Months Ended March 31,
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
March 31, 2024 | | |
Three
Months Ended
March 31, 2023 | |
Salaries and benefits | |
$ | 1,264,404 | | |
$ | 1,170,030 | |
Share-based payments | |
| 121,440 | | |
| 268,882 | |
| |
$ | 1,385,844 | | |
$ | 1,438,912 | |
As at March 31, 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 MONTHS ENDED MARCH 31, 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 months ended March 31,
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 months ended March 31, 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 May 14, 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 May 14, 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 basic research, clinical studies, and commercialization; |
| · | our
ability to develop new routes of administration of our product candidates, including parenteral,
for use in basic research, clinical studies, and commercialization; |
| · | our
ability to develop new formulations of our product candidates for use in basic research,
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 basic research 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; |
| · | 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; |
| · | 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; |
| · | 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; |
| · | 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 our products; |
| · | 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 May 14, 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 May 12, 2021, warrants arising from a "bought deal"
short form prospectus offering that closed on the same date, commenced trading on the TSX. These warrants trade under the symbol "CRDL.WT.A"
(delisted on expiry subsequent to March 31, 2024). 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) During
the 2024 Fiscal Period, the Corporation granted 455,000 stock options to certain consultants and an employee of the Corporation. Each
option allows the holder to acquire one common share of the Corporation at an exercise price of $2.56 with an expiry date of March 1,
2027. These options vest 25% every three months from the grant date. Subsequent to March 31, 2024, 75,000 options expired unexercised.
Subsequent to
March 31, 2024
(i) Subsequent
to March 31, 2024, the Corporation announced that it has exceeded 85% patient enrollment for ARCHER.
(ii) Subsequent
to March 31, 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, has accepted the manuscript describing the rationale and design of the ARCHER trial for publication.
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., thereby making CardiolRx eligible for
orphan drug status under the FDA's Orphan Drug Designation program.
The MAvERIC-Pilot
study protocol was designed to enroll 25 patients at major clinical centers in the U.S. specializing in pericarditis. In February 2024,
Corporation announced that the MAvERIC-Pilot study had achieved its patient enrollment objective. 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. |
The Corporation
expects to report topline results from the MAvERIC-Pilot study in Q2 2024 and trial extension 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 – Professor of Medicine and Cardiology and Vice Director of the
Department of Internal Medicine and Cardiology, University Medicine 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). |
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 $5 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 in recurrent pericarditis with CardiolRx, including reporting
topline primary endpoint data in Q2 2024 and trial extension data during H2 2024; |
| · | Complete
Phase II ARCHER trial in acute myocarditis with CardiolRx, including reporting topline
data in Q1, 2025; |
| · | Advance
the development of CRD-38 into a clinical program; |
The Corporation
expects that the March 31, 2024, working capital of $19,720,579 ($21,767,358 excluding the non-cash derivative liability) will be
sufficient to fund operations and capital requirements associated with achieving these corporate milestones, into 2026.
Summary of Quarterly
Results
The Corporation’s
quarterly information in the table below is prepared in accordance with IFRS.
| | |
Total | | |
Profit or (Loss) | | |
Total | |
Three Months Ended | | |
Revenue ($) | | |
Total ($) | | |
Per
Share(9) ($) | | |
Assets ($) | |
March 31,
2024(1) | | |
| nil | | |
| (9,179,632 | ) | |
| (0.14 | ) | |
| 31,126,280 | |
December 31,
2023(2) | | |
| nil | | |
| (7,637,017 | ) | |
| (0.12 | ) | |
| 36,700,508 | |
September 30,
2023(3) | | |
| nil | | |
| (5,930,185 | ) | |
| (0.11 | ) | |
| 43,053,024 | |
June 30,
2023(4) | | |
| nil | | |
| (7,471,754 | ) | |
| (0.12 | ) | |
| 47,169,272 | |
March 31,
2023(5) | | |
| nil | | |
| (7,089,336 | ) | |
| (0.11 | ) | |
| 52,685,268 | |
December 31,
2022(6) | | |
| nil | | |
| (7,515,018 | ) | |
| (0.12 | ) | |
| 62,028,518 | |
September 30,
2022(7) | | |
| nil | | |
| (7,972,047 | ) | |
| (0.13 | ) | |
| 68,358,729 | |
June 30,
2022(8) | | |
| nil | | |
| (6,489,488 | ) | |
| (0.10 | ) | |
| 74,264,968 | |
Note:
| 1. | Net
loss of $9,179,632 included general and administration of $5,082,552, research and development
of $3,322,929, and a change in derivative liability of $1,808,603. This is partially offset
by a gain on foreign exchange of $628,935, interest income of $377,294, and other income
of $28,223. |
| 2. | 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. This is partially offset by interest
income of $448,303, and a change in derivative liability of $571,656. |
| 3. | 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. |
| 4. | 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. This is partially offset by interest income of $528,697. |
| 5. | Net
loss of $7,089,336 included research and development of $4,127,696, and general and administration
of $3,658,440. This is partially offset by interest income of $545,927. |
| 6. | 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. |
| 7. | 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. |
| 8. | Net
loss of $6,489,488 included general and administration of $4,825,039, and research and development
of $4,407,182. These are partially offset by the gain on foreign exchange of $1,689,797,
and change in derivative liability of $861,600. |
| 9. | Basic
and fully diluted. |
Discussion of Operations
Three months ended March 31,
2024, compared to the three months ended March 31, 2023
For the three months ended
March 31, 2024, the Corporation’s net loss was $9,179,632, compared to a net loss of $7,089,336 for the three
months ended March 31, 2023. The increase in net loss of $2,090,296 is a result of the following:
| · | Research
and development decreased to $3,322,929 for the three months ended March 31, 2024, compared
to $4,127,696 for the three months ended March 31, 2023. During the three months ended
March 31, 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 $1,386,695 and $706,497, respectively. This compares
to $1,403,391 and $731,021, respectively, relating to ARCHER and MAvERIC-Pilot for the three
months ended March 31, 2023. |
| · | General
and administration expenses increased to $5,082,552 for the three months ended March 31,
2024, compared to $3,658,440 for the three months ended March 31, 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 three months ended March 31, 2024, included a loss on the change in
derivative liability, based on the revaluation as at March 31, 2024, of $1,808,603,
compared to the gain on the change in derivative liability for the three months ended March 31,
2023, of $74,081. |
| · | The
net loss included a gain on foreign exchange during the three months ended March 31,
2024, of $628,935, compared to a gain on foreign exchange during the three months ended March 31,
2023 of $76,792. 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 March 31,
2024, of $377,294, compared to interest income during the three months ended March 31,
2023 of $545,927. 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 March 31, 2024, totaled $20,059,172 (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 March 31,
2024, Cardiol had $28,572,975 in cash and cash equivalents (December 31, 2023 – $34,931,778).
At March 31,
2024, accounts payable and accrued liabilities were $8,853,193 (December 31, 2023 – $8,041,485). The Corporation’s cash
and cash equivalents balances as at March 31, 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 March 31,
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 $6,922,793 for the three months ended March 31, 2024. Operating activities were affected by a
net loss of $9,179,632 and the net change in non-cash working capital balances of $(31,030), and partially offset by other non-cash adjustments
of $2,287,869. Non-cash adjustments mainly consisted of $902,100 for share-based compensation, $1,808,603 for change in derivative liability
and $(491,097) 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 $811,708, partially offset by an increase in prepaid expenses of $805,504.
Cash and cash equivalents
used in investing activities were $3,460 for the three months ended March 31, 2024 as a result of the purchase of property and equipment.
Cash and cash equivalents
provided by financing activities were $76,353 for the three months ended March 31, 2024, as a result of the proceeds from stock
options exercises.
Use of Working
Capital
As of March 31,
2024, Cardiol’s working capital was $19,720,579 ($21,767,358 excluding the non-cash derivative liability). Based on current projections,
Cardiol believes that this amount is sufficient to fund operations and capital requirements, associated with achieving corporate milestones,
into 2026, as described in the “Outlook” section above.
The Corporation
has material commitments and obligations for cash resources set out below. The Corporation has no commitments for capital expenditures.
Contractual Obligations | |
Total ($) | | |
Up
to 1 year ($) | | |
1
– 3 years ($) | | |
4
– 5 years ($) | | |
After
5 years ($) |
|
Amounts payable and other
liabilities | |
| 8,853,193 | | |
| 8,853,193 | | |
| Nil | | |
| Nil | | |
Nil |
|
Office lease (1) | |
| 464,628 | | |
| 80,416 | | |
| 214,444 | | |
| 169,768 | | |
Nil |
|
Consulting agreements | |
| 465,179 | | |
| 465,179 | | |
| Nil | | |
| Nil | | |
Nil |
|
Contract research | |
| 1,580,091 | | |
| 458,176 | | |
| 1,121,915 | | |
| Nil | | |
Nil |
|
Total | |
| 11,363,091 | | |
| 9,856,964 | | |
| 1,336,359 | | |
| 169,768 | | |
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 $628,680 for the three months ended March 31,
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 - $416,792
was owed to this company and this amount was included in accounts payable and accrued liabilities.
Cardiol has an exclusive master services agreement with Dalton for the manufacturing of its
pharmaceutical cannabidiol. |
| b) | Key
Management personnel are those persons having authority and responsibility for planning,
directing, and controlling the activities of the Corporation directly or indirectly, including
any Directors (executive and non- executive) of the Corporation. Remuneration of Directors
and key Management personnel, except as noted in (a) above, was as follows: |
| |
Three months ended | | |
Three months ended | |
| |
March 31,
2024 ($) | | |
March 31,
2023 ($) | |
Salaries and benefits | |
| 1,264,404 | | |
| 1,170,030 | |
Share-based payments | |
| 121,440 | | |
| 268,882 | |
| |
| 1,385,844 | | |
| 1,438,912 | |
As at March 31,
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 68,998,313 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 | |
| |
| |
Exercise | | |
Options | | |
Options | |
Expiry date | |
price ($) | | |
outstanding | | |
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)
| |
| 50,000 | | |
| - | |
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 | | |
| - | |
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 | |
October 23, 2028 | |
| 1.20 | | |
| 30,000 | | |
| - | |
January 29, 2029 | |
| 2.56 | | |
| 30,000 | | |
| - | |
Total | |
| | | |
| 1,852,500 | | |
| 779,169 | |
(1) Exercise price denoted
in USD.
Warrants
Expiry date | |
| Exercise price ($) |
| |
Warrants outstanding |
November 5, 2024 | |
| 5.08 |
(1) | |
8,175,000 |
(1) Exercise price denoted
in USD.
Performance Share Units
The Corporation has 100,000 outstanding
performance share units ("PSUs") subject to vesting conditions specific to each grant.
Restricted Share Units
The Corporation
has 1,948,853 outstanding restricted share units ("RSUs") subject to vesting conditions specific to each grant. Of the outstanding
RSUs, 1,486,941 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 $1,613,000 (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 March 31, 2024, which include the
lease liability payments, are as follows:
Fiscal year | | |
| |
2024 | | |
| 53,611 | |
2025 | | |
| 107,222 | |
2026 | | |
| 107,222 | |
2027 | | |
| 107,222 | |
2028 | | |
| 89,351 | |
Total | | |
$ | 464,628 | |
(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 | | |
| 465,179 | |
Total | | |
$ | 465,179 | |
(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 | | |
| 458,176 | |
2025 | | |
| 1,109,206 | |
2026 | | |
| 12,708 | |
Total | | |
$ | 1,580,090 | |
Breakdown of Expensed Research and
Development
| |
Three months ended | | |
Three months ended | |
| |
March 31,
2024 ($) | | |
March 31,
2023 ($) | |
Contract research | |
| 2,438,538 | | |
| 3,241,638 | |
Wages | |
| 647,838 | | |
| 643,726 | |
Supplies | |
| 2,699 | | |
| 4,071 | |
Regulatory | |
| 180,510 | | |
| 140,856 | |
Share-based compensation | |
| 53,344 | | |
| 97,405 | |
| |
| 3,322,929 | | |
| 4,127,696 | |
Breakdown of Intangible Assets |
|
|
|
|
|
|
|
|
As at
March 31, 2024
($)
|
|
|
As at December 31, 2023
($) |
|
Exclusive global license agreement |
|
|
767,228 |
|
|
|
767,228 |
|
Accumulated amortization |
|
|
(577,981 |
) |
|
|
(556,870 |
) |
Carrying value |
|
|
189,247 |
|
|
|
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 March 31, 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 and year ended March 31, 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
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CW et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee.
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JG, Bonaventura A, Vecchié A, et al. Management of Acute and Recurrent Pericarditis: JACC State-of-the- Art Review. J
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D, Laliberté F, Majeski C, et al. Disease and economic burden associated with recurrent pericarditis in a privately insured
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SA, LeWinter MM, Magestro M, et al. Estimating the US pericarditis prevalence using national health encounter surveillance databases.
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A, Cremer P, Kontzias A, et al. US Database Study of Clinical Burden and Unmet Need in Recurrent Pericarditis. J Am Heart Assoc.
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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
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V, Sipilä J, Rautava P. Clinical profile and influences on outcomes in patients hospitalized for acute pericarditis. Circulation.
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P, Bikdeli B, Wang Y, Imazio M, Krumholz HM. Trends in acute pericarditis hospitalizations and outcomes among the elderly in the
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Ammirati E, Cipriani M, Moro C, et al. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis:
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Ammirati
E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023;329(13):1098-1113. doi:10.1001/jama.2023.3371
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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 March 31, 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 January 1, 2024 and ended on March 31, 2024 that has materially affected, or is reasonably
likely to materially affect, the issuer’s ICFR. |
Date: May 14, 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 March 31, 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 January 1, 2024 and ended on March 31, 2024 that has materially affected, or is reasonably
likely to materially affect, the issuer’s ICFR. |
Date: May 14, 2024
“Chris Waddick”
Chris Waddick
Chief Financial Officer
Grafico Azioni Cardiol Therapeutics (NASDAQ:CRDL)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Cardiol Therapeutics (NASDAQ:CRDL)
Storico
Da Gen 2024 a Gen 2025