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Cardiol Therapeutics Files US$150 Million Preliminary Base Shelf Prospectus Including Additional Disclosure Following Review by Staff of the Ontario Securities Commission

Cardiol sets up a US$150 million cross‑border shelf and adds detailed program and expense disclosure following Ontario Securities Commission review.

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Cardiol Therapeutics (CRDL) filed a US$150 million preliminary short form base shelf prospectus in Canada and a corresponding Form F‑10 registration statement with the U.S. SEC under the multijurisdictional disclosure system. No securities are being offered with this filing, and the company is not obligated to conduct any offering.

Once the final shelf is receipted and the registration statement is effective, Cardiol may issue, over a 25‑month period, Class A common shares, debt securities, warrants, subscription receipts, units, or combinations thereof, up to an aggregate initial offering price of US$150 million or equivalent. At the request of Ontario Securities Commission staff, the shelf includes expanded tabular and narrative disclosure on research and development programs, allocation of R&D spending, disaggregated general and administrative expenses, and the intended versus actual use of proceeds from the October 2024 financing.

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News Explained

The filing expands operating and spending detail and adds material contracts, while leaving previously reported financial results and financial position unchanged.

The September 10 preliminary shelf filing adds program-level, expense-component, and financing-proceeds detail without restating or changing previously reported financial statements, expenses, net loss, cash flows, cash position, or financial position.

It also files three groups of material contracts and says future continuous-disclosure filings will include the added program, expense, and proceeds-use detail.

Market Context

The July 14 Phase II publication had a reported 8.49% 24-hour price reaction and established finding...
Analysis

The July 14 Phase II publication had a reported 8.49% 24-hour price reaction and established findings supporting Phase III MAVERIC; this filing instead addressed regulatory disclosure and stated that no securities were offered.

Key Figures

Shelf capacity: US$150 million Shelf effectiveness period: 25 months
Shelf capacity
US$150 million
Aggregate initial offering price permitted under the final prospectus and Registration Statement
Shelf effectiveness period
25 months
Period during which the final short form base shelf prospectus would remain effective

Historical Context

1 past event · Latest: Jul 14
1 event
  1. Jul 14

    Phase II clinical data

    24h Move
    +8.5%

    Phase II findings supported the design of the ongoing Phase III MAVERIC trial

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

base shelf prospectus, form f-10, multijurisdictional disclosure system, new drug application, +1 more
5 terms
base shelf prospectus financial
"filed a preliminary short form base shelf prospectus"
A base shelf prospectus is a pre-approved regulatory document that lets a company register a range of securities once and then sell them to the public over time without repeating the full approval process for each offering. For investors it’s like a menu and standing permission slip: it lays out the types of securities, key risks and terms ahead of any specific sale, so buyers can assess potential dilution, timing and the company’s plans before new shares or debt hit the market.
form f-10 regulatory
"a corresponding registration statement on Form F-10"
Form F-10 is a standardized prospectus document filed with Canadian securities regulators when a Canadian company offers shares or other securities to the public. It lays out the company’s business, financial results, management, and risks—like a detailed product label that helps investors compare what they’re buying and understand potential downsides. For investors, the form matters because it provides the core information needed to evaluate the safety, value and terms of a public securities offering.
multijurisdictional disclosure system regulatory
"under the U.S./Canada Multijurisdictional Disclosure System"
A multijurisdictional disclosure system is a regulatory framework that lets a company file one set of official documents and have them accepted by regulators in multiple countries, rather than preparing separate filings for each place. For investors, it means faster, more consistent access to a company’s financial reports and material news across borders, reducing delays and making it easier to compare information the way a single, shared form simplifies multiple applications.
new drug application regulatory
"support a New Drug Application for CardiolRx"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
orphan drug designation regulatory
"The U.S. FDA has granted Orphan Drug Designation"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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TORONTO, Sept. 10, 2026 /PRNewswire/ -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a late-stage life sciences company advancing anti-inflammatory and anti-fibrotic therapies for heart disease, today announced that it has filed a preliminary short form base shelf prospectus (the "Shelf Prospectus") with the securities regulatory authorities in each of the provinces and territories of Canada, together with a corresponding registration statement on Form F-10 (the "Registration Statement") with the United States Securities and Exchange Commission (the "SEC") under the U.S./Canada Multijurisdictional Disclosure System.

Cardiol Therapeutics Inc.

No securities are being offered in connection with this announcement. The filing of the Shelf Prospectus does not obligate the Company to undertake an offering, and there can be no assurance that any securities will be offered or sold thereunder.

Once a receipt has been issued for the final short form base shelf prospectus and the Registration Statement has become effective, the filings will permit Cardiol to offer and sell, from time to time during the 25-month period the final short form base shelf prospectus remains effective, Class A common shares, debt securities, warrants, subscription receipts, units, or any combination of such securities, having an aggregate initial offering price of up to US$150 million, or the equivalent in other currencies.

Copies of the Shelf Prospectus are available under the Company's respective profiles on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov, and are available on the Company's website at www.cardiolrx.com.

"Cardiol is entering an exciting period, with several potentially transformative milestones ahead," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "Our pivotal Phase III MAVERIC trial is approaching target enrollment and is designed to generate clinical evidence to support a New Drug Application for CardiolRx™ in recurrent pericarditis, subject to favorable results and regulatory input. This represents an important step toward delivering a differentiated treatment for patients living with this debilitating disease. Positive Phase II ARCHER findings in acute myocarditis and the continued advancement of CRD-38 toward first-in-human clinical development reinforce our confidence in the breadth and promise of our pipeline."

Expanded Program and Expense Disclosure at the Request of Staff of the OSC

In connection with a review by staff of the Ontario Securities Commission (the "OSC"), and at the request of OSC staff, the Shelf Prospectus includes additional disclosure that supplements the Company's management's discussion and analysis for the year ended December 31, 2025, and for the three and six months ended June 30, 2026. No previously filed financial statement has been restated or amended, and there is no change to the Company's reported research and development or general and administrative expenses, net loss, cash flows, cash position, or financial position for any period. The additional disclosure provides additional information regarding:

  • tabular and narrative disclosure setting out, for the Company's research and development programs, the original and updated target completion dates, the original estimated cost of the current stage of development, cumulative external program expenditures incurred to date, and estimated remaining costs to completion, together with explanatory notes describing program status, anticipated next steps, and the basis on which the estimates were prepared;
  • the allocation of external research and development expenditures among those programs for each comparative period presented, together with narrative explaining the ordinary course development activities underlying period-over-period changes;
  • the disaggregation of the components of the Company's general and administrative expenses, together with additional narrative outlining the specific factors and circumstances contributing to period-over-period changes in the material components; and
  • the principal purposes for which the net proceeds of the Company's October 2024 financing completed under the Company's prior base shelf prospectus were intended to be used, and a comparison of the intended and actual use of those proceeds.

The Company will also incorporate prospective disclosure changes to its continuous disclosure filings relating to the foregoing information. The additional disclosure provides additional narrative and component-level detail regarding amounts and activities already reflected in the Company's previously filed financial statements and continuous disclosure record.

In addition, and at the request of OSC staff, the Company will be filing the following material contracts concurrently with the filing of the Shelf Prospectus:

  • Exclusive Master Services Agreement dated April 17, 2018, between the Company and Dalton Chemical Laboratories, Inc., operating as Dalton Pharma Services; and
  • Amendments dated December 7, 2018, July 2, 2019, September 11, 2019, October 28, 2019, and November 12, 2019, to the Exclusive Supply Agreement dated September 28, 2018, between the Company and Purisys, LLC, as successor and assign of Noramco, Inc.
  • Development Agreement dated August 28, 2018, between the Company and the Instituto Tecnológico y de Estudios Superiores de Monterrey's Clinical Academic Research Organization, S.A. de C.V;

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease. The Company's lead small-molecule drug candidate, CardiolRx™, modulates inflammasome pathway activation, an intracellular innate immune system response known to play an important role in the development and progression of inflammation and fibrosis associated with pericarditis, myocarditis, and heart failure.

The MAVERIC Program is evaluating CardiolRx™ for the treatment of recurrent pericarditis, an inflammatory disease of the pericardium associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits, and hospitalizations. The program comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing pivotal Phase III MAVERIC trial (NCT06708299). The U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis.

The ARCHER Program also studied CardiolRx™, specifically in acute myocarditis—an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The program comprises the completed Phase II ARCHER study (NCT05180240), which evaluated the safety, tolerability, and efficacy of CardiolRx™ in this patient population.

The Company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure—a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding US$30 billion per year.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease; the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx™; the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation intended for the treatment of inflammatory heart disease, including heart failure; the Company's future financing plans, including the potential filing of a prospectus supplement; and the Company's future approach to its continuous disclosure filings. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form filed with the Canadian securities administrators and U.S. Securities and Exchange Commission on March 31, 2026, available on SEDAR+ at sedarplus.ca and EDGAR at sec.gov, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cardiol-therapeutics-files-us150-million-preliminary-base-shelf-prospectus-including-additional-disclosure-following-review-by-staff-of-the-ontario-securities-commission-302875758.html

SOURCE Cardiol Therapeutics Inc.

FAQ

What types and amount of securities could Cardiol Therapeutics issue under the new shelf?

The shelf prospectus and Form F‑10, once final and effective, would allow Cardiol to offer and sell, from time to time during the 25‑month effectiveness period, up to an aggregate initial offering price of US$150 million, or the equivalent in other currencies. Eligible securities include Class A common shares, debt securities, warrants, subscription receipts, units, or any combination of these instruments.

Does this filing mean Cardiol Therapeutics is raising capital now?

No securities are being offered in connection with this announcement. The filing of the preliminary shelf prospectus and registration statement does not obligate Cardiol to undertake any offering, and there is no assurance that securities will be offered or sold under the shelf.

What additional disclosure has been included at the request of Ontario Securities Commission staff?

The shelf includes supplemental disclosure to management's discussion and analysis for the year ended December 31, 2025 and the three and six months ended June 30, 2026. This covers: tabular and narrative details for each research and development program (original and updated target completion dates, original estimated cost of the current stage, cumulative external expenditures to date, and estimated remaining costs, plus program status and next steps); the allocation of external R&D expenditures among programs for each comparative period and related narrative; disaggregation of general and administrative expense components with explanations of period‑over‑period changes; and the principal intended uses of net proceeds from the October 2024 financing and a comparison to the actual use of those proceeds.

Did the expanded disclosure affect Cardiol's previously reported financial results?

No previously filed financial statement has been restated or amended. There is no change to the company’s reported research and development or general and administrative expenses, net loss, cash flows, cash position, or financial position for any period. The additional disclosure provides further narrative and component‑level detail on amounts and activities already reflected in prior financial statements and continuous disclosure.

What material contracts is Cardiol filing concurrently with the shelf prospectus?

At the request of Ontario Securities Commission staff, Cardiol is filing: (i) an Exclusive Master Services Agreement dated April 17, 2018 with Dalton Chemical Laboratories, operating as Dalton Pharma Services; (ii) amendments dated December 7, 2018, July 2, 2019, September 11, 2019, October 28, 2019, and November 12, 2019 to the Exclusive Supply Agreement dated September 28, 2018 with Purisys, LLC, as successor and assign of Noramco, Inc.; and (iii) a Development Agreement dated August 28, 2018 with the Instituto Tecnológico y de Estudios Superiores de Monterrey's Clinical Academic Research Organization, S.A. de C.V.

How will Cardiol change its ongoing disclosure practices going forward?

The company will incorporate prospective disclosure changes in its continuous disclosure filings to reflect the additional program‑level and expense‑level information included in the shelf prospectus. This means future filings are expected to provide similar breakdowns of research and development program timelines and costs, allocation of external R&D expenditures, and disaggregated general and administrative expense components.

What clinical programs and pipeline assets does Cardiol highlight in this announcement?

Cardiol highlights its pivotal Phase III MAVERIC trial of CardiolRx™ for recurrent pericarditis, which is approaching target enrollment and is intended, subject to favorable results and regulatory input, to support a New Drug Application. The company also notes positive Phase II ARCHER findings of CardiolRx™ in acute myocarditis and the continued advancement of CRD‑38, a novel subcutaneous formulation under development for inflammatory heart disease including heart failure.

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