Cardiol Therapeutics Nominates Dr. Timothy Garnett to Its Board of Directors

Cardiol Therapeutics Nominates Dr. Timothy Garnett to Its Board of Directors

Former Chief Medical Officer of Eli Lilly brings more than thirty years of pharmaceutical industry experience

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced that pharmaceutical industry veteran Timothy J. Garnett, M.D., has been nominated to stand for election to the Company's Board of Directors at its 2025 Annual General Meeting of shareholders to be held on May 28, 2025.

Dr. Garnett is a distinguished pharmaceutical industry executive with over 30 years' experience, including two decades at Eli Lilly and Company, where he served as Chief Medical Officer from 2008 until his retirement in 2021. During his tenure at Eli Lilly, he led the successful development of therapeutics in women's health, endocrinology, and neuroscience, resulting in multiple global commercial launches. Dr. Garnett has played a key role in the successful development of numerous drugs across both early- and late-stage clinical development. He has broad experience leading clinical development, portfolio management, medical affairs, regulatory strategy, and safety functional areas, and has a strategic understanding of the evolving metabolic therapy landscape.

"We are pleased to nominate Dr. Garnett for election to our Board of Directors, as we mark a significant milestone with the recent initiation of patient enrollment in our pivotal Phase III MAVERIC trial," stated Guillermo Torre-Amione, M.D., Ph.D., Chair of Cardiol Therapeutics. "Dr. Garnett brings a wealth of industry experience and strategic vision, along with exceptional expertise in clinical development. His proven track record in guiding several drugs through regulatory approval and successful commercial launch will be instrumental in achieving our goal of making a meaningful difference for people living with underserved heart disease."

Dr. Garnett currently serves as Chair of Ophirex and a Director of MapLight Therapeutics. In addition, he is a member of the Advisory Panel of Cambridge Innovation Capital and an equity partner at Recode Health Ventures LLC. Dr. Garnett holds a Bachelor of Medicine and Bachelor of Surgery (MBBS) from St. George's, University of London. He is a Fellow of both the Faculty of Pharmaceutical Medicine (FFPM), and the Royal College of Obstetricians and Gynaecologists (FRCOG).

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company'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. 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 authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, 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, comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing Phase III MAVERIC trial (NCT06708299). The ongoing ARCHER trial (NCT05180240) is a Phase II study 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 US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.

Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.

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, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. 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, 2025, 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 and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.

For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/250087

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Heal the heart with innovative science.

Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis

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  • Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago.

  • Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Application.

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A replay of the live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Cardiol website (www.cardiolrx.com/investors/events-presentations/).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Cardiol website (www.cardiolrx.com/investors/events-presentations/).

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DSMC concluded that Phase 1 study may continue as planned without any modifications

On track to complete the enrollment of the first two cohorts by mid-2025

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"We greatly appreciate the DSMC's judicious review of our first cohort of patients in the Phase 1 study of 177Lu-RAD204, which allows us to advance to the higher dose cohort in a variety of PD-L1- driven cancers," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "With this clearance from the DSMC, the increased number of active centers and expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC), we expect to accelerate our timelines for complete enrolment of the next cohort by mid-2025. We believe that RAD204 has the potential to strongly improve clinical outcomes for patients with PD-L1 positive advanced cancers and we look forward to seeing data from the first two cohorts of patients later this year."

The DSMC reviewed the first cohort of four patients treated with 30mCi of 177Lu-RAD204 and confirmed that there was positive safety, pharmacokinetic and biodistribution data and agreed that the study may continue without modifications. The second cohort of patients will start at 60mCi of Lu177 rather than 40mCi previously assumed in the protocol. The second cohort of patients is expected to be enrolled by mid-year 2025 and will include expansion to multiple tumor types including NSCLC, Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer.

There are currently four clinical trial sites actively screening and recruiting patients in Australia.

About 177Lu-RAD204:

RAD204 is a single-domain monoclonal antibody (sdAb) that targets PD-L1, a protein that helps control the immune system and is overexpressed in many solid cancers, making it an attractive therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously published Phase I imaging data of 16 NSCLC patients with 99Tc-RAD204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry 2 .

Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has the potential to address resistance mechanisms to current standard-of-care treatment options.

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com .

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.

For more information:

Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com

Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

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