Cardiex is trailblazing the health technology industry through its innovative solutions that are transforming cardiovascular health care.
Cardiex Limited (ASX:CDX) is an ASX-listed medical technology company leveraging its proprietary SphygmoCor® technology to develop and market vascular biomarker technologies and digital solutions focused on the world’s largest health disorders. The company’s groundbreaking technology – SphygmoCor® – set the benchmark for noninvasive measurement of central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
While measuring arterial health parameters has always been considered clinically beneficial, it was not considered for routine out-patient clinical use as it previously required an invasive catheterization procedure with a pressure sensor inserted into the aorta. Founded on 40 years of hemodynamics studies and backed by 20+ years of research, Cardiex’s SphygmoCor technology employs non-invasive techniques to assess "central aortic waveforms," offering valuable insights into various clinically significant arterial health parameters including arterial stiffness, central blood pressure (the pressure at the heart), pulse pressure, and crucial indicators of vascular health for major organs such as the heart, brain and kidneys.
Assessing central blood pressure directly at the heart is deemed superior to conventional blood pressure measurements taken at the arm, primarily owing to the heart's proximity to vital organs. Cardiex’s FDA-cleared devices replace traditional blood pressure technology for first-line screening and monitoring of arterial health status. The unique physiologic insights from the company’s devices provide clinically relevant information that helps guide treatment decisions and offers profound benefits for all members of the healthcare community:
For Healthcare Providers: Enable physicians to make more informed treatment decisions based on clinically relevant vascular health data.
For Patients: Give patients the tools to make better decisions about their own health.
For Pharmaceutical Companies: Generate reliable, real-world, clinically relevant data to accelerate drug development and commercialization.
For more than two decades, the company’s SphygmoCor technology has set the benchmark for vascular biomarker assessments, adopted by premier hospitals and pharmaceutical giants worldwide. SphygmoCor is the chosen technology for measuring central blood pressure in all of the "top 20 hospitals" in the US and has played a crucial role in the clinical trials of leading firms including Bayer, AstraZeneca, Roche, Novartis and GlaxoSmithKline.
Between 2002 and 2023, CDX received five FDA clearances, the latest for the CONNEQT Pulse, a first-of-its-kind connected vascular biometrics monitor.
Cardiex devices have previously been sold and used exclusively in clinical settings – principally by specialist clinicians, for research, and by pharmaceutical companies for drug assessment.
The introduction of CONNEQT Pulse represents a significant shift for Cardiex, allowing the company to enter the connected care market and transition from niche segments to the mass healthcare market. Priced comparably to a home health monitor, the CONNEQT Pulse is positioned for widespread adoption and can be deployed at scale in general healthcare practices, homes, or any location where patients are present.
The CONNEQT Pulse will also bolster Cardiex's portfolio in clinical trial solutions with the introduction of a decentralized clinical trial (DCT) platform. The Cardiex DCT platform empowers clinical trial managers to remotely monitor thousands of patients in their homes, enabling pharmaceutical companies to more effectively evaluate potential vascular outcomes across various trial phases. This leads to increased efficiency and cost-effectiveness in trial outcomes.
Furthermore, in response to the growing demand for proactive health monitoring, Cardiex will be launching an innovative wrist-worn device that leverages the SphygmoCor technology to deliver a medical grade wearable with capabilities far beyond conventional health trackers. The CONNEQT Band will be a wearable “cuffless” device designed to monitor vascular health in patients as well as to provide general health insights to consumers.
Cardiex’s goal is to establish a holistic ecosystem that promotes cardiovascular well-being and empowers users to proactively manage their health as an integral part of individuals' health routines, contributing to a paradigm shift in preventive cardiovascular care.
The company’s first-mover advantage and exclusive technology FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics grant it a distinctive market position. CDX recently secured AU$14 million in funding, which is enough to steer the company towards profitability.
With the entry into the connected care home market with the CONNEQT Pulse, CDX is transitioning towards a recurring revenue model based on monthly subscription fees. This should excite investors, given that the recurring revenue model will receive a higher multiple by the market, thereby boosting the company's valuation.
CONNEQT is focused on devices and solutions for home health, remote patient monitoring, and decentralized clinical trials. Cardiex offers two devices under the CONNEQT brand – the recently FDA-cleared CONNEQT Pulse and the upcoming CONNEQT Band wearable. The company estimates CONNEQT’s total addressable market opportunity to be nearly $283 billion across three markets – remote patient monitoring ($175 billion), health wearables ($104 billion), and decentralized clinical trials ($14 billion).
CONNEQT Pulse: The CONNEQT Pulse provides measurements of both central and brachial blood pressures, alongside vascular biomarkers reflecting arterial stiffness and overall vascular health—metrics once exclusively only available to specialist clinics, research, and pharmaceutical companies. As a Bluetooth-enabled device, it empowers patients and health enthusiasts to track their arterial health from home, employing the same advanced tools used by top cardiologists in research centers and clinics.
Physicians can prescribe the CONNEQT Pulse to patients requiring heart health monitoring. Patient data seamlessly integrates with the CONNEQT Patient Management Portal (CPMP), a HIPAA-compliant cloud-based tool that enables healthcare providers to remotely track patients' arterial health by way of a tablet. Furthermore, consumers and patients can access comprehensive arterial health insights, coaching, lifestyle programs, and additional health resources via the CONNEQT app.
CONNEQT Band: CONNEQT Band is a world's-first dual sensor arterial health wearable device featuring an innovative design with dual (wrist-and finger-based) photoplethysmography (PPG) optical sensors. The wrist-based sensor continuously captures physiological data such as heart rate, respiration, stress, activity, sleep, and pulse oximetry, while our patented on-demand finger-based side sensor uniquely derives clinically meaningful vascular biomarkers representing arterial stiffness and cardiovascular health.
By combining data from both sensors, the CONNEQT Band offers users a comprehensive view of their overall cardiovascular health which has never been available outside of a physician’s office. The CONNEQT Band is also supported by the CONNEQT app, available for both iOS and Android devices, which serves as a hub where users can easily access detailed reports, track their progress over time, explore content, and receive personalized health insights and recommendations.
The CONNEQT Band is currently in the process of FDA submission preparation. This innovative device is poised to extend the company's portfolio in connected health technology, offering users a new, user-friendly tool for monitoring their health metrics. With its cutting-edge features, the CONNEQT Band is expected to make a significant impact in the way individuals manage their wellness, bridging the gap between advanced health monitoring and everyday convenience.
A significant global market opportunity in wearable health devices is driven by nearly 1.3 billion hypertensive and other vascular disease patients. Some of the other wearable device firms have attracted significant funding at high valuations in recent times. For instance, Oura Health, a Finnish company that makes smart rings for tracking sleep and physical activity, was valued at $2.55 billion in April 2022.
Craig Cooper has established numerous prosperous health, digital media, technology and wellness ventures. Notably, he co-founded Boost Mobile, a prominent telecommunications company recognized as one of the leading mobile phone businesses in the USA. He is acknowledged as a distinguished authority and influential figure on a global scale in mobile and wireless technology, as well as businesses related to digital health and medical technology. His venture capital endeavors have secured over AU$3 billion, financing some of the most impactful global digital media technology companies. Cooper is also a principal of C2 Ventures, Cardiex’s largest shareholder.
Niall Cairns boasts a successful 25-year record of investing in both private and public companies. He has played a pivotal role in advancing the global expansion of more than 50 enterprises spanning various sectors, including digital media, agtech, medtech, consumer internet, and SaaS-based businesses. Cairns is also a principal of C2 Ventures, Cardiex’s largest shareholder.
King Nelson brings over 30 years of extensive experience in medical devices. He was previously the president and CEO at Uptake Medical Corporation, concentrating on treatments for emphysema and lung cancer. Before Uptake, he served as president and CEO of Kerberos Proximal Solutions, a company later acquired by FoxHollow Technologies. He was also president and CEO of VenPro, a heart valve business acquired by Medtronic. King also accumulated 19 years of experience with Baxter International and American Hospital Supply Corporation, progressing through various roles with increasing responsibilities. These roles included serving as division president for Dade Diagnostics, Bentley Labs, and Baxter’s Perfusion Services. Nelson is currently the CEO at Q’Apel Medical, a medical device company specializing in neurovascular disease.
Charlie Taylor has over three decades of international advisory experience and recently concluded his tenure as senior partner at McKinsey, where he oversaw the health and public sector practice. Taylor has counseled numerous private and public sector healthcare organizations in Australia and globally, covering areas such as strategy, digitalization, operational enhancements, growth transformations, international expansion, supply chain management, mergers and acquisitions, and board governance. He is a non-executive director of Healius, a leading Australian health diagnostics company, and a part-time senior board advisor at McKinsey for the health and public sector practice.
Dr. Sanjeev Bhavnani has served as a senior medical officer at the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health (CDRH), overseeing clinical and scientific initiatives concerning digital health and medical devices incorporating artificial intelligence.
Bhavnani is also currently a senior cardiologist and principal investigator of digital health and machine learning at Scripps Clinic in San Diego, California, where he leads programs to develop and validate new technologies and to evaluate the safety and effectiveness of DHTs, nanosensors, cloud-based analytical platforms, handheld imaging technologies, AI/ML algorithms and software as a medical device. For over a decade, Bhavnani was the principal investigator of 90 clinical trials and patient care programs. These programs have enrolled over 30,000 patients in the US and in resource-limited areas. His team developed the SMART-FHIR integration interface for DHT data into EMRs for remote patient monitoring, remote therapeutic monitoring, and chronic care management, creating a real-world data platform to monitor the healthcare quality of DHT and ML devices in traditional and new consumer models of care delivery.
Catherine Liao has served as our chief strategy officer since September 2022. Previously, Liao served as chief executive officer of Blumio, a pioneering medical device startup, from February 2016 to September 2022, where she led efforts in raising capital, formed a leadership and advisory board rich in knowledge spanning healthcare innovations, enterprise technology, and sensor technology. Her notable achievements include leading the commercialization of a groundbreaking medical radar sensor development platform, which garnered significant industry attention and was eventually acquired by Cardiex. Liao holds an MBA from Imperial College London and a Master of Science in Health Economics from the London School of Economics. These credentials underscore her deep and comprehensive insight into the intricacies of both the business world and the healthcare sector, demonstrating a balanced expertise critical for navigating and innovating within today’s complex healthcare economies.
Dr. Mark Gorelick has served as Cardiex’s chief product officer since December 2020, bringing a wealth of experience from various leadership roles in the health and wellness technology sector. With an impressive tenure beginning in 2007, he has been at the helm as managing director of XPhys Technologies, a company at the forefront of developing innovative fitness, health, and wellness products. His strategic vision was further demonstrated through his role as vice-president of Digital Health, from 2018 to 2019, at Performance Lab Technologies, acclaimed for its software development prowess in the health sector. Further cementing his reputation in health technology, Gorelick served as the chief science officer at PAI Health (originally Mio Global) from 2015 to 2018, where he was instrumental in advancing health technology software solutions. Holding a BSc and MSc in kinesiology from Dalhousie University and a Ph.D. in biomedical science from University of Wollongong, Gorelick’s educational background underscores his deep-rooted understanding and innovative approach to biomedical science and kinesiology, reinforcing his invaluable contribution to our company and the broader health technology landscape.
Biomarker technologies and digital solutions to address the world’s largest health disorders.
Approximately two months after the chain-wide launch of CWENCH's hydration mix powder in Fortinos stores (February of 2025), CWENCH Hydration™ is now fully represented at Fortinos with the addition of its ready-to-drink Tetra Pak® format at all Fortinos locations, strengthening the footprint of CWENCH Hydration™ in key Ontario population centres where the Company is strategically commercializing its flagship product line.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , is pleased to announce that Loblaw banner supermarket chain Fortinos has added the ready-to-drink ("RTD") format of CWENCH Hydration™ to all 24 of its locations throughout the Greater Toronto and Greater Hamilton areas in Southern Ontario. All four original flavours of CWENCH Hydration™ RTD were officially added to Fortinos stores starting on Thursday, April 17, 2025.
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All four original flavours of CWENCH Hydration™ in the ready-to-drink format are now available for purchase at Fortinos stores in the Greater Toronto and Greater Hamilton areas, as well as through PC Express
This launch of CWENCH Hydration™ in its RTD format at all Fortinos locations complements the successful February launch of CWENCH's Hydration Mix across the chain's stores .
In addition to availability of CWENCH Hydration™ RTD and hydration mix in all Fortinos supermarket locations, the full product line can be purchased online through PC Express , which can be done through this link . PC Express is an online shopping portal for Loblaw banner stores, offering "Click and Collect" curbside/in-store pickup as well as delivery options for households in markets across Canada with over 700 pickup locations .
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "We had high expectations for CWENCH at Fortinos and it has performed better than we had expected. So we are pumped that they have picked up the RTD format of CWENCH which expands the availability of our products across their chain. As a company based in the Greater Toronto area, we know what a good fit Fortinos is for CWENCH Hydration™ as a consumer brand. We will continue developing this business relationship within the Loblaw chain, as we make each of our calculated and strategic moves to keep capturing market share in the hydration category, in which CWENCH is only continuing to grow."
About Cizzle Brands Corporation
Cizzle Brands Corporation is a sports nutrition company that is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration™, a better-for-you sports drink that is now carried in over 1,800 locations in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH Hydration™, please visit: https://www.cwenchhydration.com
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
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For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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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.
Data from Cardiol's Phase II MAvERIC-Pilot study presented at the American Heart Association Scientific Sessions 2024 showed that pericarditis patients treated with CardiolRx™ experienced marked and rapid reductions in pericarditis pain and inflammation, and a substantial reduction in the number of pericarditis recurrences per year.
Recurrent pericarditis is a debilitating heart condition that results in chest pain, shortness of breath and fatigue, physical limitations, reduced quality of life, and hospitalizations.
CardiolRx™, which has been granted US FDA Orphan Drug Designation for this indication, is a small molecule oral drug targeting inflammasome pathway activation that is central to the development and progression of pericarditis.
Toronto, Ontario--(Newsfile Corp. - April 16, 2025) - 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, announced today that Northwestern University has enrolled the first patient in the pivotal Phase III MAVERIC trial ("MAVERIC") evaluating Cardiol's lead drug candidate CardiolRx™ for the prevention of recurrent pericarditis. This multi-center, randomized, double-blind, placebo-controlled trial is designed to definitively assess the impact of CardiolRx™ on preventing recurrent pericarditis in patients at high risk for disease relapse and to support regulatory approval.
MAVERIC is currently being initiated at pre-eminent cardiovascular clinical research sites throughout the United States under an Investigational New Drug application authorized by the United States Food and Drug Administration ("US FDA"). The MAVERIC Program and Phase III leadership comprises an independent committee of international thought leaders in pericardial disease and clinical trial design: Allan Klein, MD, CM from Cleveland Clinic (MAVERIC Program Chair); Massimo Imazio, MD, FESC from University of Udine, Italy (MAVERIC Program Co-Chair); Paul Cremer, MD from Northwestern University (MAVERIC Trial Principal Investigator); Allen Luis, MBBS, PhD from Mayo Clinic Rochester (MAvERIC-Pilot Principal Investigator); Antonio Abbate, MD, PhD from University of Virginia; and, Stephen Nicholls, MBBS, PhD from Monash University, Melbourne, Australia.
"Recurrent pericarditis remains a challenging condition to manage and can significantly impact patients' quality of life. There is a pressing need for new treatment options earlier in the care pathway, before resorting to second- and third-line therapies such as corticosteroids or IL-1 blockers," commented Paul C. Cremer, MD, MAVERIC Trial Principal Investigator. "In collaboration with research centers across the United States, Canada, and Europe, we look forward to completing this important study of a new oral therapy with the potential to improve the treatment paradigm for this underserved patient population."
"Initiation of the MAVERIC Phase III trial is an important milestone in our Company's efforts to provide a more accessible, non-immunosuppressive therapeutic option for thousands of pericarditis patients. We congratulate Dr. Cremer and his colleagues at Northwestern for recruiting MAVERIC's first patient and we are grateful for the interest shown by our collaborators from other leading pericardial disease centers who will be participating in the study," said David Elsley, President and CEO of Cardiol Therapeutics. "Based on the strength and consistency of the data from our Phase II MAvERIC-Pilot study, we believe that CardiolRx™ can make a meaningful difference in the lives of pericarditis patients."
MAVERIC is a Phase III, multi-center, randomized, double-blind, placebo-controlled trial designed to enroll 110 patients with recurrent pericarditis at approximately 20 clinical sites across the United States, Canada, and Europe. Patients who have been treated with an interleukin-1 ("IL-1") blocker for at least 12 months and are scheduled to have this treatment discontinued, will be randomly assigned to receive either CardiolRx™ or placebo following cessation of the IL-1 blocker. Discontinuation of IL-1 blocker therapy is associated with a high risk for recurrence and has been reported to occur within 12 weeks in up to 75% of patients. The primary clinical objective of the trial will be to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis at 24 weeks. Other clinical endpoints include time to a new episode of pericarditis recurrence, and changes in patient-reported pericarditis chest pain score and changes to the inflammatory marker C-reactive protein.
MAVERIC, formerly referred to as MAVERIC-2, follows positive results from Cardiol's Phase II MAvERIC-Pilot study. Data from MAvERIC-Pilot were previously reported on November 18 at the American Heart Association Scientific Sessions 2024 and showed that patients experienced marked and rapid reductions in both pericarditis pain and inflammation that were maintained throughout the study. In addition, the results demonstrated a substantial reduction in pericarditis episodes per year. Treatment with CardiolRx™ was shown to be safe and well tolerated in a patient population who presented with a high degree of disease burden.
About Pericarditis
Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart), which frequently results from a viral infection. Patients may have multiple recurrences following that initial episode, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States experiencing at least one recurrence is estimated at 38,000. Approximately 60% of patients with more than one recurrence suffer for more than two years, and one third remain impacted at five years. Hospitalization due to recurrent pericarditis is typically associated with a 6-8-day stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
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 molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities, timelines associated with such activities, and potential success of 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 of cannabidiol intended for use in heart failure, the newly published data providing additional important rationale for the development of CRD-38 as a new approach to the treatment of heart failure, and the JACBTS publication provides fascinating new data that suggest a key mode of action of CRD-38 to potentially treat heart failure is through its ability to sustain cardiomyocytes and preserve mitochondrial function. 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, regulatory approvals, clinical studies and uncertainties in predicting treatment outcomes. 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 Company's Annual Information Form filed on March 31, 2025.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
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The placement of CWENCH Hydration™ at United Supermarkets, a well-known chain of supermarkets in central and northern Texas, is part of Cizzle Brands' plan to strategically add to its U.S. presence in 2025.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , is pleased to announce that the hydration mix format of its flagship product CWENCH Hydration™ is being carried by United Supermarkets , a grocery chain with a substantial presence in central and northern Texas, which includes urban areas such as Lubbock, Amarillo, Odessa, and Abilene.
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The 10-count hydration mix format of CWENCH Hydration™ is sold by United Supermarkets in Texas.
As of April 2025, the original four flavours of CWENCH Hydration™ (Blue Raspberry, Cherry Lime, Rainbow Swirl, and Berry Crush) are being sold in the 10-count hydration mix packet format in-store at United Supermarkets. All four SKUs are also available through United Supermarkets' online ordering portal.
United Supermarkets is part of The United Family , which is a wholly-owned subsidiary of S&P MidCap 400 ® component Albertsons Companies, Inc. , one of the largest supermarket chains in the United States. The United Family operates 99 stores under five different banners, serving 1.5 million guests per week in 54 Texas and New Mexico communities.
So far in its Fiscal 2025 year, 20% of the Company's $5.64 million in net sales took place in the United States. As Cizzle Brands seeks to further scale the market share of CWENCH Hydration™ across North America, the Company has undertaken initiatives (such as becoming the Official Hydration Partner of USA Hockey) to fortify its U.S. footprint, alongside the strategic selection of retail partners such as United Supermarkets in key geographic areas.
CWENCH Hydration™ is already carried across the Life Time chain of athletic country clubs in the United States, including at over 30 locations across the state of Texas. This placement with United Supermarkets is therefore expected to complement the brand's existing presence in several Texas regions.
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "Each market is different in terms of the optimal tactics for launching a sports nutrition brand. This is why we're taking a patient, strategic, and selective approach to establishing CWENCH Hydration™ in specific U.S. markets, partnering with established and well-known local chains who have the reach and the capabilities to introduce the product to our target audience. We are proud to have CWENCH Hydration™ carried by United Supermarkets in Texas, and we look forward to building out our distribution pipeline in this dynamic and high-growth region of the United States."
About Cizzle Brands Corporation
Cizzle Brands Corporation is a sports nutrition company that is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration™, a better-for-you sports drink that is now carried in over 1,800 locations in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport ® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH Hydration™, please visit: https://www.cwenchhydration.com
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250410440469/en/
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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The availability of CWENCH Hydration™ in its ready-to-drink format at all 134 Metro locations in Ontario follows only three months after the initial launch of CWENCH's Hydration Mix with Metro in its Ontario stores.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , is pleased to announce that the ready-to-drink ("RTD") version of the four original flavours of CWENCH Hydration™ (Rainbow Swirl, Blue Raspberry, Cherry Lime, and Berry Crush) are now being carried in all 134 Metro supermarket locations in Ontario. This placement fortifies the presence of CWENCH Hydration™ in key Southern Ontario markets including the Greater Toronto Area, Ottawa, and London, as well as throughout Northern Ontario markets including Sudbury, North Bay, Sault Ste. Marie, and Thunder Bay.
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The ready-to-drink format of CWENCH Hydration™ is now offered for sale in all 134 Metro locations in Ontario
CWENCH Hydration™ is the flagship offering of Cizzle Brands and was first launched in the North American market in late May of 2024. It has since been picked up by over 1,800 points of distribution around the world with double-digit growth across its top North American accounts as of March 2025, and was the primary driving force behind Cizzle Brands' $5.64 million in net sales achieved during the first half of its 2025 fiscal year (as announced in the Company's March 17, 2025 earnings press release).
METRO Inc. is a food and pharmacy leader in Quebec and Ontario, operating a network of 995 food stores (as of December 21, 2024) under several banners including Metro , Metro Plus , Super C , Food Basics , Adonis , and Première Moisson , and 640 pharmacies primarily under the Jean Coutu , Brunet , Metro Pharmacy , and Food Basics Pharmacy banners.
The launch of CWENCH Hydration™ in its RTD format in all Metro Ontario stores follows on from the launch of its Hydration Mix in 47 Metro Ontario stores in January as well as its launch of both RTD and Hydration Mix formats at over 100 stores in Quebec in March.
More information about METRO Inc. and its retail banners can be found on the METRO corporate website: https://corpo.metro.ca/en/home.html
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "Our business relationship with METRO Inc. is continuing to grow and drive value, and we are happy to share that the success of CWENCH Hydration™ in Ontario and Quebec has led to broader distribution across Metro banners in both provinces. More and more Canadians of all ages are seeking and asking for CWENCH by name, which means that having the product available across chains such as Metro is an important aspect of gaining market share in the sports drink category. Cizzle Brands is proud to be a supplier to METRO Inc., and we look forward to continuing to work together as part of the growth journey for CWENCH Hydration™."
Charles Buhagiar, Sr. Category Manager of OTC, Health and Wellness for METRO Inc. commented, "The Hydration Mix SKUs of CWENCH Hydration are now available in Metro Ontario grocery and pharmacy stores since being added to planograms at the beginning of this year. We are therefore pleased to continue stocking CWENCH Hydration Mix in addition to the brand's ready-to-drink offerings in our Ontario stores, just in time for the spring and summer seasons when it is all the more important to have a healthy hydration option as well as supporting Canadian brands."
About Cizzle Brands Corporation
Cizzle Brands Corporation is a sports nutrition company that is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration™, a better-for-you sports drink that is now carried in over 1,800 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH Hydration™, please visit: https://www.cwenchhydration.com
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
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For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo
UPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial
Advances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG
Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine's potential to benefit patients.
"The FDA approval of UPLIZNA marks a significant turning point for IgG4-RD patients and physicians who now have a proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. "We are proud to deliver a therapy that has the potential to significantly improve care for patients with IgG4-RD and remain encouraged by UPLIZNA's broader potential in other immune-mediated diseases, including neuromyelitis optica spectrum disorder and generalized myasthenia gravis. This approval underscores Amgen's ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas."
IgG4-RD can occur in multiple organs and lead to fibrosis and permanent organ damage. 1,2 Understanding how organ damage manifests is critically important to inform the timely diagnosis of IgG4-RD. The disease mimics other diseases due to the heterogeneous and unpredictable inflammatory flares that can occur. 3 Over time, IgG4-RD can affect virtually any organ system. 1
"Targeting CD19+ B cells with UPLIZNA has proven to be a highly effective approach to help address the pathophysiology of IgG4-RD," said John Stone , M.D., M.P.H., principal investigator, and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. "The clinical community now has an FDA-approved therapeutic innovation for patients that targets underlying disease mechanisms and helps to control disease activity by reducing flares in IgG4-RD. Now, our work begins in raising awareness of this disease so that patients can access the right treatment as early as possible, avoiding a long and often harmful diagnostic journey."
The approval of UPLIZNA for IgG4-RD is supported by data from the MITIGATE trial, the first randomized, double-blind, placebo-controlled trial conducted in IgG4-RD. 1 This trial demonstrated the potential of UPLIZNA to decrease disease activity by reducing flares in patients, while maintaining its efficacy and established safety profile. 1
This is the second approved indication for UPLIZNA, which was previously approved by the FDA for the treatment of adult patients with AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) in June 2020 . The FDA also granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG). Regulatory filing activities are underway for gMG with submission anticipated to be complete in H1 2025.
Amgen is committed to supporting patients with IgG4-RD and helping appropriate patients with access to UPLIZNA. Patients and caregivers who need support, tools or resources can contact Amgen By Your Side .
About the MITIGATE Trial
MITIGATE is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial designed to evaluate the efficacy and safety of UPLIZNA compared to placebo in reducing the risk of flares in adults with IgG4-RD. 1
The primary endpoint was time to first treated and adjudicated IgG4-RD flare. 1 The three key secondary endpoints were annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission. 1 The MITIGATE trial also includes an optional three-year open-label treatment period and a safety follow-up period after UPLIZNA discontinuation of up to two years.
Key findings from the MITIGATE trial include (p values are formatted to align with New England Journal of Medicine standards): 1
The most common adverse reactions in patients with IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection (12%) and lymphopenia (19%).
About Immunoglobulin G4-related disease (IgG4-RD)
Immunoglobulin G4-related disease (IgG4-RD) is a chronic, systemic, immune-mediated, fibroinflammatory disease which can affect numerous and generally multiple organs of the body. 1 It is a progressive disease that can affect a variety of organ systems and often affects multiple organs over time. It is characterized by periods of remission and unpredictable disease flares. 4,5 IgG4-RD can cause permanent organ damage with or without the presence of symptoms. 2 Awareness of how organ damage manifests is critically important to inform the timely diagnosis of IgG4-RD. B cells are central to the pathogenesis of IgG4-RD. 1 In IgG4-RD, CD19-expressing (CD19+) B cells are thought to drive inflammatory and fibrotic processes and interact with other immune cells that contribute to disease activity. 1,2
The prevalence is estimated at 20,000 people in the United States (5 in 100,000 worldwide), although the number of IgG4-RD patients is difficult to determine based on limited epidemiology data. 1,2 The typical age of onset of IgG4-RD is between 50 and 70 years old and, unlike many other immune-mediated diseases, IgG4-RD is more likely to occur in men than women. 4
About UPLIZNA ® (inebilizumab-cdon)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects in IgG4-RD is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.
UPLIZNA ® (inebilizumab-cdon) U.S. INDICATION
INDICATIONS
UPLIZNA ® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
UPLIZNA ® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
UPLIZNA ® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis.
WARNINGS AND PRECAUTIONS
Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.
Hepatitis B Virus (HBV) Reactivation : Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML ): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Tuberculosis
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.
Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
ADVERSE REACTIONS
Please see UPLIZNA ® full Prescribing Information.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads .
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on Amgen's acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen's business, outcomes, progress and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Madison Howard , 773-635-4910 (media)
Justin Claeys , 805-313-9775 (investors)
References
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SOURCE Amgen
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As a proud supporter of grassroots hockey across North America, Cizzle Brands is embracing this opportunity to further enhance its U.S. presence with brand visibility throughout the entire USA Hockey network by virtue of this multi-year sponsorship.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , is pleased to announce that CWENCH Hydration™ is now the official hydration partner of USA Hockey , which is the national governing body for the sport of ice hockey in the United States and includes more than one million players, coaches, officials and volunteers across the country.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250403845444/en/
CWENCH Hydration™ has become the official hydration partner of USA Hockey.
CWENCH Hydration™ will be featured prominently at USA Hockey player development camps , the Chipotle All-American Game (featuring the top American-born NHL Draft eligible prospects), and the Rivalry Series (between USA Hockey and Hockey Canada, televised on the NHL Network). Additionally, CWENCH Hydration™ will have a significant presence at all youth and girls' national championships, as well as a significant presence at the USA Hockey National Team Development Program and at various National Team camps. Furthermore, CWENCH Hydration™ will benefit from visibility across USA Hockey's range of digital and online properties, including USA Hockey Magazine , its lineup of newsletters, the USAHockey.com website, and USA Hockey social media channels.
This partnership is part of a multi-year sponsorship agreement between the Company and USA Hockey, adding to Cizzle Brands' portfolio of sponsorships in support of grassroots athletics across North America. This includes its arena sponsorship with Canlan Sports (anchored by the CWENCH Centre in Toronto), CWENCH's endorsement deal with Canadian youth hockey influencer Coach Chippy , and the title sponsorship of the CWENCH All Canadian Basketball Games (which will be televised on TSN this weekend).
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "We are thrilled about CWENCH Hydration™ becoming the official hydration partner of USA Hockey, which has been a household name in the North American hockey community for generations. We are strategically building up CWENCH's presence in the United States as we commercialize the product line across key North American markets. As we approach the one-year anniversary of the launch of CWENCH, we continue to form partnerships that massively increase visibility and awareness for the brand. This agreement with USA Hockey is one of those partnerships."
"It's exciting to welcome CWENCH to our USA Hockey family," said Pat Kelleher , Executive Director of USA Hockey. "It's no secret the importance of hydration in our sport and it's great to have the partnership and expertise of CWENCH to help our athletes be at their best."
About Cizzle Brands Corporation
Cizzle Brands Corporation is a sports nutrition company that is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration™, a better-for-you sports drink that is now carried in over 1,800 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH Hydration™, please visit: https://www.cwenchhydration.com
About USA Hockey
USA Hockey, established on October 29, 1937, and headquartered in Colorado Springs, Colorado, provides the foundation for the sport of ice hockey in America; helps young people become leaders, sometimes Olympic or Paralympic heroes; and connects the game at every level while promoting a lifelong love of the sport. USA Hockey is more than a million strong, including players, coaches, officials and volunteers that span all 50 states. The National Governing Body for the sport in the United States, USA Hockey has important partnerships with the NHL, United States Olympic and Paralympic Committee and International Ice Hockey Federation. For more information, visit usahockey.com .
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250403845444/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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