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In January 2025, Cizzle Brands announced its initial placement in select Metro locations in Ontario. An expanded product range has now been added to more than half of all Metro stores in Quebec.
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Cardiex Limited
Investor Insight
Cardiex is trailblazing the health technology industry through its innovative solutions that are transforming cardiovascular health care.
Overview
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.
Company Highlights
- Cardiex Limited is an ASX-listed medical technology company that develops and markets vascular biomarker technologies and digital solutions for the world’s largest health disorders.
- The company’s offerings encompass FDA-cleared medical and home health devices alongside digital solutions tailored for managing health and wellness, delivering unique physiologic insights that inform clinical treatment decisions.
- The company’s groundbreaking technology – named SphygmoCor® – set the benchmark for measuring central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
- These biomarkers, extensively researched and detailed in numerous peer-reviewed journals, assess cardiovascular risk and guide disease management by predicting organ damage (such as the heart, brain, and kidneys) and outcomes (including heart failure, ischemic heart disease, and stroke), significantly influencing disease prognosis and clinical treatment.
- CDX received five FDA clearances from 2002 to 2023, the most recent for the CONNEQT Pulse, a world-first connected vascular biometric monitor. The CONNEQT Pulse targets new and significant healthcare channels and transitions the company towards a recurring revenue model based on monthly subscription fees.
- CDX's technology is uniquely FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics – thereby granting it a distinctive competitive market position. With a significant funding round recently secured, CDX is poised for profitability ahead.
- CDX more than doubled its annual company revenue and other income to $12.4 million in 2024, compared to $6 million in 2023.
Products and Solutions
CONNEQT
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.
Board of Directors and Management
Craig Cooper – Chief Executive Officer and Executive Director
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 - Executive Chairman
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 – Non-executive Director
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 – Non-executive Director
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.
Sanjeev Bhavnani – Chief Clinical Officer
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 – Chief Strategy Officer
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.
Mark Gorelick – Chief Product Officer
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.
Cizzle Brands Begins Distributing CWENCH Hydration to Metro Grocery Stores in Quebec
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , is pleased to announce that METRO Inc., food and pharmacy leader in Québec and Ontario, has started carrying CWENCH Hydration™ in Metro stores in the province of Quebec, alongside Metro stores in Ontario that are already carrying CWENCH Hydration™ products.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250325984171/en/
Following the success in Metro Inc. stores in Ontario, CWENCH Hydration™ is now available at Metro Inc. stores across the Province of Quebec.
Cizzle Brands continues to strategically scale the brand footprint of CWENCH Hydration™ across Canada, and this placement fortifies the Company's growth in the Quebec market. Recent developments in Quebec include commercial site distribution of CWENCH Hydration™ through Montreal-based Van Houtte Coffee Services (who services over 3,000 locations in the Montreal area alone) and full distribution across MacEwen-owned gas stations in both Ontario and Quebec.
In a press release dated January 9, 2025 , Cizzle Brands announced that 47 Metro supermarkets in Ontario were to begin carrying Hydration Mix packets of CWENCH Hydration™ in their pharmacy sections.
Based on early-stage performance of CWENCH Hydration™ in Metro's Ontario stores, Cizzle Brands has worked with METRO Inc. to make the following additional placements of the product in the grocer's Quebec locations:
- CWENCH Hydration™ Ready-to-Drink ("RTD") Rainbow Swirl , Blue Raspberry , Cherry Lime , and Berry Crush flavours are now sold in approximately 130 Metro supermarkets in Quebec; and
- Hydration Mix in the 10-Count packet format for CWENCH Hydration™ flavours Rainbow Swirl and Blue Raspberry are now sold in approximately 100 Metro supermarkets in Quebec.
As of December 21, 2024, METRO Inc. operates a network of some 995 food stores 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. More information about METRO can be found on its website: https://corpo.metro.ca/en/home.html
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "We are pleased that CWENCH Hydration™ has performed well in Metro supermarkets in Ontario, leading to an expansion into their locations in the Quebec market. Grocery is proving to be an important category for us, particularly because there are many more opportunities to drive awareness of new products ( e.g. , through floor displays, weekly flyers, etc.) which we can leverage to encourage first-time purchase conversions. Working with the METRO Inc. team has been a great pleasure for us, and we look forward to continuing this relationship as we seek to further establish CWENCH Hydration™ as a leading name in sports beverages."
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 1,200 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
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/20250325984171/en/
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Cizzle Brands Lands Title Sponsorship for the CWENCH All Canadian Basketball Games
CWENCH Hydration™ has become the title sponsor of the CWENCH All Canadian Basketball Games, alongside other sponsors including Nike, TSN and Team Town. Cizzle Brands continues to build out its portfolio of sponsorships in Canadian grassroots sports, driving visibility for CWENCH Hydration™ as a healthy and great-tasting hydration option for athletes of all ages.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , is pleased to announce that its flagship brand CWENCH Hydration™ is gaining further prominence in Canadian athletics through a five-year title sponsorship agreement of the CWENCH All Canadian Basketball Games, a three-day NBA-sanctioned event for Canadian male and female senior high school basketball players taking place on Friday, April 4, 2025 and Saturday, April 5, 2025. The event will be broadcast across Canada on TSN, and will have pre-promotion during the network's coverage of the NCAA® March Madness® tournaments this month.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250320762204/en/
CWENCH Hydration is now title sponsor of the CWENCH All Canadian Games, a three-day event that celebrates Canada's top 24 senior male and female Canadian high school basketball players.
In addition to title sponsorship of the CWENCH All Canadian Basketball Games, the five-year agreement provides Cizzle Brands with comprehensive sponsorship rights for the promotion of its brands. This includes the naming rights for the event, naming rights for the CWENCH Player of the Game, the CWENCH logo appearing on all players' jerseys, commercial spots during the national broadcast on TSN, bench rights and exclusivity in the hydration category.
Also, as part the event, all of the athletes will take part in clinical sweat-testing trials to measure the impact that CWENCH Hydration™ has on performance.
Supporting grassroots sports initiatives in Canada is core to Cizzle Brands' ethos as a company, and has proven to be especially impactful for the early-stage growth of CWENCH Hydration™ in the North American marketplace. In addition to Cizzle Brands' recently announced sponsorship of the CWENCH All Canadian Volleyball Games, CWENCH also sponsors 500 youth hockey teams in Canada, representing over 12,000 youth hockey players. Last year, Cizzle Brands also obtained a sponsorship deal with Canlan Sports for a major four-rink hockey complex in the Toronto area, which is now named CWENCH Centre - A Canlan Sports Community . These efforts have contributed to driving strong demand for CWENCH Hydration™, with many of its leading retail and distribution partners re-ordering product at a fast pace, as further detailed in the Company's March 6, 2025 press release.
The CWENCH All Canadian Games will feature the top 24 senior male and female Canadian high school basketball players as selected by a committee including provincial and national representatives, clubs, coaches, scouts, and media from across the country. At the Athlete Institute in Orangeville, Ontario (near Toronto), participants engage in a series of activities over three days. These activities include on-and-off court training, practices and scrimmages in front of NBA personnel, a 3-Point Shootout, a Slam Dunk Competition, and Boys and Girls games. As an NBA-sanctioned event, the CWENCH All Canadian Basketball Games attract representation from the majority of the National Basketball Association's organizations.
More information about the CWENCH All Canadian Basketball Games can be found on the event's website: https://www.cwenchallcanadian.com .
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "We are delighted to sponsor the CWENCH All Canadian Basketball Games. The impact that this event has had on Canadians coast-to-coast is staggering. From a brand recognition standpoint, it will be instrumental to our continued growth and, as an organization, we take great pride in supporting grassroots athletics across Canada. The CWENCH All-Canadian Games will be a key catalyst for the continued growth of CWENCH Hydration™."
Jesse Tipping, CEO of the Athlete Institute Ltd., which is organizing games, added: "Cizzle Brands is an incredible Canadian company that puts the needs and health of young athletes at the forefront. I am proud to have CWENCH Hydration™ be the title sponsor for the games and look forward to our future together."
"As the Official Broadcaster of the CWENCH All Canadian Games, it's an honour for TSN to shine the spotlight on Canada's emerging young basketball players," said Shawn Redmond, VP, Bell Media Sports. "Canadian players are making a massive impact on the sport at all levels, and the CWENCH All Canadian Games are a key stepping stone, ensuring the next generation has a national platform to showcase their talents for fans."
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 1,200 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
For more information about the CWENCH All Canadian Games, please visit: https://www.cwenchallcanadian.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/20250320762204/en/
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Cizzle Brands Corporation Reports $5.64 Million in Net Sales in the First Half of its 2025 Fiscal Year
For the six-month period ended January 31, 2025, Cizzle Brands recorded over $5.64 million in net sales, with a gross profit margin of 60.03% and gross profit of over $3.38 million. These earnings were primarily driven by sales of CWENCH Hydration™ in Canada, with sustained sales of the product in the United States and Europe. The Company has publicly filed its financial results for the second quarter of its 2025 fiscal year, and its management team will be hosting a webcast to discuss these results on Thursday, March 27, 2025.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTCQB: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") , today released its financial results for the second quarter of its 2025 fiscal year (three months ended January 31, 2025, referred to herein as "FQ2 2025"). The results for FQ2 2025 capped off the first half of Cizzle Brands' inaugural fiscal year as a public company, in which more than $5.64 million in net sales were generated, with 60.03% gross profit margin and gross profit of over $3.38 million.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250317771206/en/
During FQ2 2025 Cizzle Brands' common shares became listed on the Cboe Canada stock exchange, an event that was commemorated by the bell-ringing ceremony pictured above at the exchange's Toronto office
Throughout the first half of the Company's 2025 fiscal year, Cizzle Brands accelerated strategic commercialization efforts for its flagship product CWENCH Hydration™ while also carrying out the launch of Spoken Nutrition , a brand of premium, athlete-grade nutraceuticals. During this period, 71% of Cizzle Brands' sales were made in Canada, with 20% and 9% coming from the United States and Europe, respectively.
Key highlights from Cizzle Brands' FQ2 2025 earnings are listed below. All figures are in Canadian Dollars unless otherwise specified.
- Net sales for FQ2 2025 were $2,856,072 with Cost of Goods Sold being $1,216,689 for gross profit margin of 57.4%;
- Current Assets grew by 43.3% from $7,220,755 at July 31, 2024 to $10,347,341 at January 31, 2025;
- Growth of Current Assets was primarily driven by a 72.8% increase in Cash from $1,519,516 to $2,626,915 and a 126.7% increase in Inventory from $1,376,990 to $3,122,031 between the same two dates;
- All product inventory is "current" with no obsolete inventory and no provisions to inventory having been made;
- CWENCH Hydration™ is available in over 1,800 points of distribution across North America, including sites serviced by Van Houtte Coffee Services (a subsidiary of Keurig Dr Pepper), whose established Canada-wide network of over 30,000 doors reduces Cizzle Brands' overhead expenses for logistics and can allow the Company to scale the footprint of CWENCH Hydration™ more rapidly;
- Several key retail partners for CWENCH Hydration™ were added during the Company's FQ2 2025 including Metro Ontario , MacEwen Petroleum , Canco Petroleum , Fortinos , Sport Chek, Source for Sports, and Life Time Fitness , which is an upscale chain of fitness resorts with over 160 locations across North America; and
- Re-order rates for CWENCH Hydration™ have been growing steadily for the Company. In a press release dated March 6, 2025 , Cizzle Brands announced that all accounts which have existed for two or more months have placed at least one reorder. With Cizzle Brands' largest Canadian account during FQ2 2025, the two Hydration Mix versions of CWENCH Hydration™ (10-count and 315-gram) have experienced unit sales growth of 72% and 64% (respectively) between FQ2 2025 and the prior fiscal quarter.
Please refer to Cizzle Brands' profile on SEDAR+ ( http://www.sedarplus.ca/ ) to view the Company's full FQ2 2025 earnings reports, as well as its corresponding Management Discussion and Analysis ("MD&A").
Additionally, Cizzle Brands will be hosting a webcast on Thursday, March 27, 2025 at 4:30 PM ET in which the Company's management team will discuss these results in greater detail. Registration (free) is required to attend, and can be done through the following link: https://streamyard.com/watch/htXpXqNJzhUR
Please refer to the Company's March 13, 2025 press release or contact Cizzle Brands Investor Relations for more information regarding the upcoming webcast.
Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza commented, "The first half of our fiscal 2025 year was very successful, with the team achieving key milestones against our strategic plan. To have generated over $5.64 million in net sales in just six months is a testament to the brand strength we are creating. Our next two fiscal quarters will take place during spring and summer when sales within our hydration category tend to be higher. Based on this, Cizzle Brands is on track to surpass $14 million in net sales by the end of our first complete fiscal year."
Mr. Celenza continued, "This momentum reflects our team's dedication to growth, the quality of our products, and most importantly the traction we have begun to garner at the consumer level, which is driving repeat purchases as well as organic acquisition of new customers through word-of-mouth. We will continue scaling our business by driving growth through existing channels, and by selectively adding new channels at each step of our commercialization journey. We have significant opportunities in front of us in both Canada and the United States that we are well-positioned to capitalize on, and we will be sharing many of these developments over the coming weeks. We look forward to discussing these financial results on next week's webcast."
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
For more information about the CWENCH All Canadian Games, please visit: https://www.cwenchallcanadian.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/20250317771206/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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UPLIZNA® SIGNIFICANTLY IMPROVES GENERALIZED MYASTHENIA GRAVIS SYMPTOMS IN ACETYLCHOLINE RECEPTOR AUTOANTIBODY-POSITIVE PATIENTS OVER 52 WEEKS
Patients Reported Improvement in Ability to Conduct Daily Activities with Twice-Yearly Dosing *
Late-Breaking Data to be Presented at AAN 2025
- Amgen (NASDAQ:AMGN) today announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA ® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG). The results demonstrated durable and sustained efficacy of UPLIZNA in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG with two doses a year, following an initial loading dose. Findings will be presented as a late-breaking oral presentation during the American Academy of Neurology (AAN) Annual Meeting on April 8, 2025 in San Diego .
The Phase 3 MINT trial, which was a randomized-control trial, evaluated UPLIZNA in muscle-specific kinase autoantibody-positive (MuSK+) and AChR+ gMG patients, with the MuSK+ group followed for 26 weeks and the AChR+ group followed for 52 weeks. The trial demonstrated continued improvement in efficacy of UPLIZNA compared to placebo (adjusted difference, −2.8, 95% CI, −3.9 to −1.7) as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ subpopulation through week 52. Among the AChR+ patients in the UPLIZNA group, 72.3% had a ≥3 point improvement in the MG-ADL score, compared to 45.2% in placebo. 1
As previously disclosed at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting, the trial met its primary endpoint, with a statistically significant change from baseline in MG-ADL score for UPLIZNA (-4.2) compared with placebo (-2.2) (difference: –1.9, p
"The 52-week MINT trial results highlight the potential for a new standard of care in gMG, offering durable symptom relief with a simplified treatment regimen," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. "These findings reinforce UPLIZNA's ability to provide sustained symptom relief with just two doses per year—an important advancement for patients living with generalized myasthenia gravis—while underscoring our commitment to developing transformative therapies for people facing complex autoimmune diseases."
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score was also greater for patients in the UPLIZNA group as compared to placebo at Week 52 (adjusted difference, −4.3, 95% CI, −5.9 to −2.8). Among the AChR+ patients in the UPLIZNA group, 69.2% improved by ≥3 points in the QMG score, compared to 41.8% in the placebo group. 1
MINT was the first and only Phase 3 trial for a biologic to incorporate a corticosteroid taper into its protocol. Patients who entered the study taking corticosteroids were tapered down starting at Week 4 to prednisone 5 mg per day by Week 24.
"I'm looking forward to further examining the 52-week MINT data with my colleagues in the neurology community at AAN," said Richard J. Nowak , M.D., M.S., global principal study investigator and director of the Myasthenia Gravis Clinic at Yale University . "These results showed that UPLIZNA consistently relieved burdensome symptoms and improved activities of daily living for gMG patients."
No new safety signals were identified. The overall TEAE profile during the study period is consistent with the known safety profile for the approved indication (NMOSD). The most common adverse events included infusion-related reactions, nasopharyngitis and urinary tract infections.
UPLIZNA is currently approved for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) and is under priority FDA review for the treatment of Immunoglobulin G4-related disease (IgG4-RD) with a PDUFA date of April 3, 2025 . The FDA has granted UPLIZNA Orphan Drug Designation for the treatment of gMG. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025.
*After an initial loading dose.
About the MINT Trial
The MINT trial is a randomized, double-blind, placebo-controlled, parallel-group trial ( NCT04524273 ) evaluating the efficacy and safety of UPLIZNA in adults with gMG. The trial enrolled 238 adults with gMG, including 190 patients who are acetylcholine receptor autoantibody-positive (AChR+) and 48 patients who are muscle-specific kinase autoantibody-positive (MuSK+).
Eligibility criteria at screening and randomization included a Myasthenia Gravis Foundation of America (MGFA) classification of II, III, or IV disease, MG-ADL score between 6 and 10 with greater than 50% of this score attributed to non-ocular items, or an MG-ADL score of at least 11, QMG score of at least 11, and use of a corticosteroid and/or non-steroidal immunosuppressant.
The primary endpoint was change from baseline in MG-ADL score at Week 26 in the combined population. Key secondary endpoints included change from baseline in QMG scores in the combined study population; change from baseline in MG-ADL score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort; and change from baseline in QMG score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort. Patients who entered the study taking a corticosteroid were tapered down to prednisone 5 mg a day, starting at Week 4 to Week 24. The MINT trial also includes an optional three-year open-label treatment period.
About Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis (gMG) is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision. 2-4
Approximately 85% of patients with myasthenia gravis have the generalized form, or gMG. 5,6
The prevalence and incidence of gMG are increasing worldwide. 6 There are between 80,000 and 100,000 patients with myasthenia gravis in the U.S. 7,8 Approximately 85% of patients with myasthenia gravis have detectable antibodies against AChR, and approximately 7% have detectable antibodies against MuSK. 9 Global prevalence is estimated at 2-36 cases per 100,000. 10 The disease is more frequently seen in young women (age 20-30) and men aged 50 years and older. 6,10
B cells are central to the pathogenesis of gMG. The disease is thought to be primarily driven by pathogenic CD19+ plasmablasts and plasma cells that target critical proteins in the neuromuscular junction. 2-4
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 is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.
About UPLIZNA in NMOSD
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
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.
IMPORTANT SAFETY INFORMATION
UPLIZNA is contraindicated in patients with:
- A history of life-threatening infusion reaction to UPLIZNA
- Active hepatitis B infection
- Active or untreated latent tuberculosis
WARNINGS AND PRECAUTIONS
Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.
Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.
The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.
Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (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. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.
Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.
Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.
Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.
Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.
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), our 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 our 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 our 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 our 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 we project. 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, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.
Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our 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 our products and global economic conditions. In addition, sales of our 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, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our 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 our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our 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 we have acquired, may not be successful. There can be no guarantee that we 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. We 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 our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
The scientific information discussed in this news release relating to new indications for our product is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the product. The product is not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the product for these uses.
CONTACT: Amgen, Thousand Oaks
Madison Howard , 773-636-4910 (media)
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
References
- Nowak R, Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT): Efficacy Data in AChR+ Generalized MG Subpopulation Through Week-52 [Late-breaking oral presentation]. To be presented at American Academy of Neurology Annual Meeting ( 5-9 April 2025 ). Available at: www.aan.com/msa/Public/Events/AbstractDetails/61470
- Yi, J. S., Guptill, J. T., Stathopoulos, P., Nowak, R. J., & O'Connor, K. C. (2018). B cells in the pathophysiology of myasthenia gravis. Muscle Nerve , 57(2):172-184.
- Willcox H. N., Newsom-Davis, J., & Calder, L. R. (1984). Cell types required for anti-acetylcholine receptor antibody synthesis by cultured thymocytes and blood lymphocytes in myasthenia gravis. Clinical and Experimental Immunology ., 58:97-106.
- Stathopoulos P., Kumar, A., Nowak, R. J., & O'Connor, K. C. (2017). Autoantibody-producing plasmablasts after B cell depletion identified in muscle-specific kinase myasthenia gravis. JCI Insight, 2(17):e94263.
- Lazaridis K., & Tzartos, S. J. (2020). Autoantibody Specificities in Myasthenia Gravis; Implications for Improved Diagnostics and Therapeutics . Frontiers in Immunology, 11:212.
- Dresser L., Wlodarski, R., Rezania, K., & Soliven, B. (2021). Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. J Clin Med, 10(11):2235.
- Ye et al. Frontiers in Neurology. (2024);15:1339167.
- Rodrigues E., Umeh, E., Aishwarya, Navaratnarajah, N., Cole, A., & Moy, K. (2024). Incidence and prevalence of myasthenia gravis in the United States : A claims-based analysis. Muscle Nerve, 69(2):166-171.
- Hehir, M. K., & Silvestri, N. J. (2018). Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology. Neurologic Clinics, 36:253-60.
- Bubuioc, A. M., Kudebayeva, A., Turuspekova, S., Lisnic, V., & Leone, M. A. (2021). The epidemiology of myasthenia gravis. Journal of Medicine and Life, 14(1):7-16.
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SOURCE Amgen
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