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As the Use of AI In Healthcare Grows, Cardio Diagnostic Is Using It In Quest to Help Prevent Cardiovascular Disease

Cardio Diagnostics Holdings, Inc

By Faith Ashmore, Benzinga In the United States, one person dies from cardiovascular disease every 33 seconds, and nearly one in every four deaths is attributed to heart disease. It is the leading cause of death for men, women and people of most racial and ethnic groups across the board. In 2021, cardiovascular disease cost the U.S. approximately $219 billion and those numbers are only expected to go up if nothing changes. Fortunately, many of the deaths associated with heart disease are preventable if health professionals are able to leverage modern technology to educate and treat effectively. The Global Burden of Disease (GBD) study and the Global Burden of Cardiovascular Diseases Collaboration have provided valuable perspectives on the urgency of developing comprehensive strategies to address these risks and enhance public health. According to Gregory A. Roth, MD, MPH, the senior author of the paper, associate professor in the Division of Cardiology, and director of the Program in Cardiovascular Health Metrics at the Institute for Health Metrics and Evaluation at the University of Washington, "Cardiovascular diseases continue to pose a persistent challenge, resulting in a significant number of premature and preventable deaths." Combining advanced clinical diagnostic solutions with digital health, Artificial Intelligence (AI) and value-based care initiatives can accelerate how organizations tackle cardiovascular disease. How AI Can Be Instrumental In The Fight Against Heart Disease In 2023, the market for AI in healthcare was forecasted to reach $20.65 billion, and it is predicted to reach $187.95 billion by 2030. This is not surprising to most because the implementation of AI in healthcare has brought about a transformative shift in the industry, enabling a personalized approach to patient care. AI algorithms can effectively handle and analyze extensive medical data, including epigenetic, genetic information and DNA-based biomarkers. Healthcare providers now have the capability to make precise and personalized treatment choices, taking into account an individual's specific biology, which ultimately enhances patient outcomes. By utilizing AI-powered systems, patterns can be identified, potential health issues can be predicted, and real-time monitoring can be conducted, facilitating early intervention and preventive measures. Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, is one company leading the charge in developing solutions to combat cardiovascular disease. Both the mission and capabilities of Cardio Diagnostics align with the healthcare sector's demands for leveraging cutting-edge molecular and AI technologies to drive preventive care, earlier disease detection, and chronic disease management. By employing AI and machine learning, the company can help empower healthcare providers to proactively identify high-risk populations and intervene early, leading to enhanced health outcomes and cost reductions across a broad spectrum of organizations. How The Use of Telemedicine Is Making Care More Accessible To All Communities COVID-19 dramatically changed the landscape of telehealth, and four years after the pandemic began, it looks like telehealth is here to stay. In 2023, MGMA Stat did a poll with medical group leaders to get an understanding of the current landscape of telehealth – 45% believed telehealth demand would remain mostly the same, while 27% of respondents said they expected an increase. Telemedicine capabilities have been especially helpful in rural areas that had been experiencing physician shortages before the pandemic. In rural communities, Cardio Diagnostics makes specialty cardiovascular care accessible. The divide between urban and rural healthcare options can be bridged by deploying innovative solutions. When provider organizations and employers in rural settings adopt Cardio’s solutions, which couple telehealth to advanced AI-powered DNA tests, they can drive access to highly accurate diagnostics without extensive travel or the need for specialized infrastructure. The company's solutions enhance accessibility and convenience while optimizing specialty care for patients in underserved communities where travel distances and limited access to healthcare facilities present roadblocks to timely medical attention. Cardio Diagnostics empowers healthcare organizations by enabling primary care physicians to identify cardiovascular risk and status upstream before specialty cardiology becomes necessary, ultimately delivering value-based care. The Future Of Healthcare As cardiovascular disease remains a major concern for doctors and families, modern technology must evolve how we approach prevention and treatment. Companies like Cardio Diagnostics are key to bringing AI into the fold while using digital health technologies such as telemedicine to expand healthcare possibilities and provide value-based care. Featured photo by National Cancer Institute on Unsplash. Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com. Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Gene Mannheimer - Investor Relations +1 855-226-9991 investors@cardiodiagnosticsinc.com Company Website https://cardiodiagnosticsinc.com/

April 24, 2024 08:30 AM Eastern Daylight Time

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AGC Biologics Announces Successful Completion of Production of Cancer-Specific Therapeutic Antibody Fragments with Var2 Pharmaceuticals

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the completion of work with VAR2 Pharmaceuticals on the production of the company’s two antibody candidates targeting cancer-specific carbohydrate structures for cancer treatment. The CDMO’s work included information transfer and master cell bank creation, method implementation, pilot-scale evaluations, preparation for large-scale manufacturing, regulatory documentation support for EMA or FDA guidelines and product stability studies. "We prioritize unparalleled support for every project we undertake, ensuring our clients receive the highest level of service and satisfaction. This project is a good example of how fast we are able to deliver results in close collaboration with our clients," said Dieter Kramer, General Manager of AGC Biologics Heidelberg. VAR2 Pharmaceuticals proprietary antibody fragments –Vartumabs – have been shown to bind with high affinity and high specificity to onco-fetal Chondroitin Sulfate, a pan-cancer, tumor-specific glycosaminoglycan first identified by VAR2 Pharmaceuticals. The two antibody fragments produced in collaboration with AGC Biologics will be used in an upcoming, first-in-human, nuclear imaging microdosing study paving the way for efficacy trials with an ADC. AGC Biologics runs multiple cGMP microbial production lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages, including commercial production. In addition to protein-based biologics, the site serves as the CDMO’s Center of Excellence for plasmid DNA (pDNA) and messenger RNA (mRNA), offering full-scale support for microbial drug substances, plasmid materials, starting material for in-vitro transcription mRNA vaccines, and raw material for adeno-associated vectors and lentiviral vectors. The AGC Biologics Heidelberg facility has been producing biopharmaceuticals for four decades. The facility offers developer partners a segregated line design that increases flexibility and cGMP compliance. To learn more about microbial system-based biologics, pDNA, and mRNA development and manufacturing at AGC Biologics Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on our Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to www.agcbio.com. About VAR2 Pharmaceuticals ApS VAR2 Pharmaceuticals is a near-clinical stage biotechnology company developing first-in-class therapeutics for onco-fetal Chondroitin Sulfate, a pan-cancer, tumor-specific glycosaminoglycan discovered by VAR2 Pharmaceuticals during malaria research. Founded in 2012, VAR2 Pharmaceuticals is based in Copenhagen and has raised >€20M to date. Our experienced team of innovators and scientists are committed to developing safe and effective cancer therapies targeting this unique cancer-specific carbohydrate modification, with a particular focus on hard-to-treat, recurrent and metastatic cancers. For additional information, please visit www.var2pharma.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

April 24, 2024 12:04 AM Mountain Daylight Time

PharmAla Biotech Advances Global MDMA Production and Research

PharmAla Biotech Holdings Inc

PharmAla Biotech Nick Kadysh joined Steve Darling from Proactive to share exciting developments, announcing significant milestones achieved by the company's joint venture, Cortexa Pty., in Australia. Cortexa has commenced batch manufacturing of GMP LaNeo MDMA 40mg capsules, marking an Australian first. These capsules will support both clinical trials and clinical use under the TGA's Authorised Prescriber pathway. PharmAla's mission is twofold: to address the global shortage of clinical-grade MDMA for clinical trials and commercial sales in selected jurisdictions, and to develop novel drugs in the same class. As the sole provider of clinical-grade MDMA for patient treatments outside of clinical trials, PharmAla is uniquely positioned in the market. According to Kadysh, Cortexa's achievement of domestic Australian manufacturing represents a significant milestone in the local psychedelic landscape. This move strengthens Cortexa's leadership position by establishing a reliable local supply, eliminating the costly and time-consuming burden of importation, and providing seamless access to medication for clinicians and researchers. In addition to this achievement, PharmAla has successfully closed a previously announced non-brokered private placement, raising gross proceeds of $750,000. The company plans to allocate the net proceeds towards securing global patent rights for its portfolio of novel intellectual property assets, manufacturing products for sale, and funding clinical trials for its patented drug candidates. Contact Details Proactive North America Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

April 23, 2024 07:01 PM Eastern Daylight Time

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Lisata Therapeutics advances lead asset LSTA1 for treatment of advanced solid tumors

Lisata Therapeutics Inc

Lisata Therapeutics CEO David J. Mazzo discusses the oncology company's focus and recent advancements in an interview with Proactive's Stephen Gunnion. Lisata Therapeutics, established 18 months ago through the acquisition of Cend Therapeutics by Caladrius Biosciences, is dedicated to developing technologies aimed at treating solid tumour cancers. The company's primary product, certepetide (LSTA1) is a nine amino acid cyclic peptide designed to target and penetrate tumours. It is used in combination with chemotherapy and other cancer treatments. Currently, the most advanced programme targets metastatic pancreatic ductal adenocarcinoma, with phase 2B results expected later this year. Lisata has also received several orphan drug designations, including for pancreatic cancer, glioblastoma, and osteosarcoma. Additionally, it has a rare paediatric disease designation for osteosarcoma in the US. Mazzo highlighted discussions with regulatory authorities in Australia, the EMA, and the FDA about potential accelerated approval based on upcoming trial results. He expressed optimism about commercializing List-1 as early as 2026 under ideal conditions. Investors can look forward to various clinical and data milestones in the next 12 to 18 months, including potential business development activities. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 23, 2024 10:48 AM Eastern Daylight Time

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ANGLE achieves breakthrough with EU patent for CellKeep technology, with the US to follow

ANGLE PLC

ANGLE PLC chief executive Andrew Newland discussed significant advancements in the company's technology, including a European patent for the CellKeep slide, with US intellectual property protection from the US set to follow soon. Newland told Proactive's Stephen Gunnion that CellKeep significantly improves the deposition of cancer cells on microscope slides, a common issue in medical laboratories. This method notably reduces cell loss during the transfer process by over 70%, addressing a longstanding problem in the industry. The innovation involves a special funnel attached to the slide, allowing gentle centrifugation and liquid removal while maintaining cell integrity, thereby increasing the effectiveness of subsequent analyses. Additionally, Newland highlighted the development of optimized antibodies for cell phenotyping, which are integrated into ANGLE's Parsortix system. This integration is packaged as the Portrait Plus CTC Staining Kit, simplifying the process for less experienced labs and extending market reach. The kit includes a mix of dehydrated antibodies, designed for ease of use and long shelf life, enhancing the diagnostic process's reliability and efficiency. Commercially, ANGLE has introduced these innovations in a comprehensive kit format, priced at £3,000 for ten samples, significantly enhancing the company’s value offering. Newland also touched on ANGLE’s positive business trajectory, mentioning a breakthrough in DNA profiling and a substantial contract with a major pharmaceutical company, which could potentially yield significant revenues through the development of companion diagnostics. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 23, 2024 09:17 AM Eastern Daylight Time

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World-Renowned Neurologist and Bestselling Author Joins Forum Health’s Annual Integrative Medicine Summit

Forum Health

Forum Health, LLC, leading nationwide network of integrative and functional medicine providers, is thrilled to announce Dr. Dale Bredesen, a trailblazing neuroscientist and pioneer in Alzheimer's disease research, as the keynote speaker at the Forum Health Summit: Emerging Therapies in Integrative Medicine. Register for the Forum Health Summit here. With a career spanning over four decades, Dr. Bredesen has made groundbreaking contributions to neurological research, cognitive decline treatment, and Alzheimer's disease with his renowned Bredesen Protocol - the only Alzheimer’s treatment where the most patients have stabilized or improved. Dale Bredesen, MD: “I’m honored to be the keynote speaker at Forum Health’s annual summit. They are setting the stage to discuss the latest advancements in integrative medicine, bringing together the nation’s top providers, and providing me with the opportunity to share insights and collaborate with my colleagues to drive innovation and progress." Dr. Bredesen's presentation will delve into the latest advancements in Alzheimer's research and shed light on the importance of personalized medicine in combating cognitive decline. Attendees will receive invaluable insights into treatment modalities and preventative measures to preserve brain health. Phil Hagerman, Forum Health CEO: "We’re thrilled to have Dr. Bredesen join us this year. His unparalleled expertise and contributions to the medical community have been instrumental in advancing new treatment approaches to transform the landscape of Alzheimer's disease." The Forum Health Summit is a one-day conference that brings together the top thought leaders in integrative and functional medicine. Attendees receive the latest on emerging research, cutting-edge diagnosis, and treatment protocols for complex clinical cases from expert leaders in the field. The event will also feature presentations from industry experts including: Sahar Swidan, Pharm.D., BCPS, ABAAHP, FAARFM, FACA - President and CEO of NeuroPharm, and internationally renowned speaker on pain management and HRT Paul Anderson, MD - Recognized educator and clinician in integrative and naturopathic medicine focused on complex infecious, chronic and oncologic illnesses Thomas G. Gulliams, Ph.D. - Former VP of Ortho Molecular and expert in the therapeutic uses of dietary supplements Registration for this event is exclusive to licensed medical professionals, space limited and this event is expected to sell out. Register here. About Forum Health Forum Health, LLC is a nationwide provider of personalized healthcare steeped in the powerful principles of functional and integrative medicine. Our providers take a root-cause approach to care exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Members have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships. For more, visit www.forumhealth.com. Contact Details Forum Health Britt Wittelsberger +1 410-852-0738 bwittelsberger@forumhealth.com Company Website https://forumhealth.com

April 23, 2024 08:50 AM Eastern Daylight Time

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Wolfram and Classiq Integrate Advanced Quantum Software Tools into Mathematica

Classiq Technologies

In a landmark collaboration, Classiq, a leader in quantum computing software, and Wolfram Research, the leading computational software provider, announce a software partnership. This collaboration integrates Classiq’s cutting-edge engine within Wolfram Mathematica, offering a unified solution for the development of quantum and classical algorithms. This integration is targeted at enabling users to leverage the robust capabilities of Wolfram Mathematica for algorithm development and utilize Classiq’s Quantum Model (QMOD) language for quantum algorithm development—all within a single, cohesive environment. This blend of technologies empowers users to define, visualize and optimize quantum algorithms with unprecedented ease and efficiency. Key features of this collaboration are the facilitation of Classiq’s quantum algorithm compilation tailored to specific quantum hardware and ability to intricately develop quantum circuits from a high-level overview down to detailed gate operations. The integration further allows for the execution of these quantum circuits across a diverse array of backends and simulators, directly within the Mathematica notebook. This integration supports researchers by enhancing analytical capabilities, enabling continuous exploration and data assessment. As an example of the potential of this collaboration, the Quantum Differential Equations solver exemplifies how users will be able to tackle complex challenges by defining and executing quantum algorithms like the Harrow–Hassidim–Lloyd (HHL) algorithm and Quantum Singular Value Transformation (QSVT) for matrix inversion, directly from the Mathematica interface. This application highlights the power of combining classical computational methods with quantum processing to solve complex computational problems more efficiently. “The partnership between Classiq Technologies and Wolfram Research reflects a shared commitment to advancing computational excellence,” said Nir Minerbi, CEO of Classiq. “This collaboration not only enhances the toolset available for researchers and developers, we hope to see it pave the way for groundbreaking applications across various scientific and engineering disciplines.” "In the pursuit of applying quantum technologies to address real-world challenges, robust collaboration among industry leaders is paramount. We are delighted to unveil our strategic partnership with Classiq," remarked Mads Bahrami, quantum projects manager at Wolfram. "This partnership underscores the dedication of both entities towards crafting toolsets that empower governments, industries, and academia to tackle complex problems through quantum-classical algorithms." The companies invite those seeking to combine the best of quantum and classical computation to reach out and explore the possibilities this computation integration brings. About Wolfram Founded by Stephen Wolfram in 1987, Wolfram Research is one of the world's most respected computer, web and cloud software companies - as well as a powerhouse of scientific and technical innovation. As a pioneer in computation and computational knowledge, Wolfram has pursued a long-term vision to develop the science, technology and tools to make computation an ever-more-potent force in today's and tomorrow's world. As the creators of Mathematica, Wolfram|Alpha, the Wolfram Language, and Wolfram Quantum Framework, Wolfram is the leader in developing technology and tools that inject sophisticated computation and knowledge into everything. Wolfram's strategy as an organization is to maintain a portfolio of development, from continually strengthening core algorithms and the Wolfram Knowledgebase, to supporting the latest computing and deployment architectures, to developing major new concepts and capabilities - and consistently delivering the results in the form of products, services and experimental initiatives that make breakthrough technology accessible to the broadest possible spectrum of people and organizations. Learn more at: https://wolfr.am/QuantumConsulting https://www.wolfram.com/quantum-computation-framework/ Follow Wolfram on LinkedIn, X, and YouTube. Contact Wolfram quantum team: quantum@wolfram.com Contact Wolfram PR team: outreach@wolfram.com About Classiq Classiq Technologies, the leading quantum software company, provides an all-encompassing platform (IDE, compiler and OS) with a single point of entry into quantum computing, taking you from algorithm design to execution. The high-level descriptive quantum software development environment, tailored to all levels of developer proficiency, automates quantum programming. This ensures that a broad range of talents, including those with backgrounds in AI, ML and linear algebra, can harness quantum computing without requiring deep, specialized knowledge of quantum physics. Classiq democratizes access to quantum computing and equips its users to take full advantage of the quantum computing revolution, including access to a broad range of quantum hardware. Classiq's core technology - algorithmic quantum circuit compilation - is engineered to power the quantum ecosystem of today and the future. Classiq works closely with quantum cloud providers and advanced computation hardware developers providing software for use with quantum computers, HPC and quantum simulators. Backed by investors such as HPE, HSBC, Samsung, Intesa Sanpaolo and NTT, Classiq's world-class team of scientists and engineers has distilled decades of quantum expertise into its groundbreaking quantum engine. Follow Classiq on LinkedIn, X (formerly Twitter) or YouTube, and visit the Slack community and website, www.classiq.io to learn more. Contact Details Rainier Communications Michelle McMahon +1 781-718-3248 classiqPR@rainierco.com Company Website http://www.classiq.io/

April 23, 2024 08:00 AM Eastern Daylight Time

6 Stocks Positioned to Soar as Investors Focus on MASH

AKRO, MDGL, VKTX, LLY

Investors are making a lot of money on obesity plays. Obesity is at epidemic proportions, so it's easy to see why obesity drugs including GLP-1 agonists have exploded in the marketplace. This class of drugs was originally designed to manage blood sugar levels in diabetics but was expanded to treat obesity, an even bigger market. JP Morgan analyst Richard Vosser estimated the global obesity drug market will reach $71 billion by 2032. The first approval of Byetta® was in 2005 but the market has since grown to include a bunch of diabetes drugs you’ve heard on TV ads like Trulicity®, Victoza®, Adlyxin®, Ozempic®, Rybelsus®, and Mounjaro®. Blockbuster drugs like Ozempic, now called Wegovy®, and Mounjaro, now called Zepbound®, were repurposed as obesity drugs. This repurposing trend is a common theme in the biotech space. The only issue is that obesity has become a common theme, which ultimately makes it a crowded trade and harder to pick the winners and losers. Combination drugs like survodutide, retatrutide, and cagrisema are up-and-coming drugs in phase 3 development for obesity, but investing in these names means you are simply following the herd. Investing requires leading with an edge and some forethought. This article highlights pure-play drug developers in MASH likely to be the focus of investors looking for the next big thing in biotech. Looking Beyond GLP-1 Inhibitors Toward the MASH Epidemic Drug makers like Eli Lilly (NYSE: LLY) with their drug Mounjaro (tirzepatide) have already repurposed their drug once and are looking beyond diabetes and obesity, with their eyes set on and an even more lucrative market of metabolic dysfunction-associated steatohepatitis (MASH). LLY has promising interim clinical data showing 74% of overweight adults who took the higher dose of tirzepatide cleared MASH versus 12.6% in placebo. The first approval of a MASH drug on March 15, 2024 by Madrigal Pharmaceuticals (NASDAQ: MDGL) has ignited the sector with investors looking for the next big pure play. Multiple MASH Targets Metabolic dysfunction-associated steatohepatitis (MASH) is a complicated disease on the regulatory front. Approval criteria are a resolution of MASH symptoms via biopsy without a worsening of fibrosis. The disease formerly known as nonalcoholic steatohepatitis (NASH) is caused by a buildup of fat in the liver that leads to complications which include fibrosis (scarring of the liver), cirrhosis (severe scarring of the liver), and liver cancer. Once MASH progresses this far, liver transplantation is currently the only viable option. After MDGL’s approval of Rezdiffera®, investors have been flocking to other MASH names looking for a follow-on drug that either works in combination with Rezdiffera or one that is superior in safety and efficacy. MASH Drug Targets MASH has several druggable targets. The GLP-1 target is the mainstream approach because it also treats type 2 diabetes. Next in terms of a drug target is the fibroblast growth factor 21 (FGF21) which has a number of players in late-stage development. Galectin-3 is another target for MASH drugs as research has shown it is implicated in fibrotic and inflammatory feedback loops. There are also promising drugs that target the thyroid hormone receptor beta (THRβ). Breaking from the mainstream approaches is the A3 adenosine receptor (A3AR) which is highly expressed in inflammatory and cancer cells whereas low expression is found in normal body cells. FGF21 Agonists 89Bio Inc. (NASDAQ: ETNB) is developing a lead molecule called pegozafermin which is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). It is similar in mechanism of action to Bristol Myers Squibb’s (NYSE: BMY) drug pegbelfermin which was discontinued despite positive results which showed more than half the patients having NASH resolution at 16 weeks. FGF21 analogues are taken via subcutaneous injection. The targeting of the FGF21 pathway helps regulate metabolism and cellular process, especially in the liver fat tissue. Balancing out this metabolic pathway helps reduce liver fat, which can result in reduction in liver fibrosis (scarring) over time. The company has strong fibrosis data with favorable tolerability and dosing convenience. The long term data suggests there is a cumulative impact on patients taking background GLP-1 therapy. ETNB’s phase 3 program in MASH could achieve accelerated approval using histology in non-cirrhotic (F2-F3) and cirrhotic (F4) patients although the FDA has acknowledged greater importance in clinical outcomes and not histology. They have clinical trials in both fibrosis and cirrhosis and expect to initiate their cirrhosis trial in Q2 2024. The company has almost $600 million in cash with a market cap of $875 million. The slight premium over cash, solid and consistent trial results, along with short and long-term catalysts make this an attractive setup for investors. This is the first on the top 6 list. Akero Therapeutics (NASDAQ: AKRO) is also targeting MASH and MASH cirrhosis with an FGF21 agonist. Their drug is called efruxifermin and is commonly referred to as EFX. In their phase 2b MASH trial they showed a 65% reduction in liver fat content vs 11% in placebo which places them close to the front of the pack because it was done in only 12 weeks. Unfortunately, their phase 2b trial in MASH missed the endpoint for improvement in liver fibrosis at the 12-week time frame but showed 60% had MASH resolution after 36 weeks versus 26% in placebo. The company lost a lot of value on that readout but the statistics show a cleanly designed trial is likely to hit the regulatory endpoints. Guidance from an end-of-trial FDA meeting is forthcoming, but the timing is still uncertain and weighing on the stock price. While there is a lot of potential in this name, the uncertain timing of the regulatory pathway makes this ideal for the patient investor looking more for a NASH cirrhosis play. The company is well funded with over $550 million in cash and a $1.5 billion market cap. Galectin-3 Antagonists Galectin Therapeutics (NASDAQ: GALT) has an adaptive design phase 2/3 study in NASH cirrhosis with an interim readout before year end 2024. Their intravenously administered galectin antagonist called belapectin showed complete prevention of esophageal varices in a phase 2 trial despite failing to meet their (now defunct) primary endpoints. Their pivotal trial used lessons learned from the phase 2 trial, utilizing a primary endpoint of prevention of esophageal varices. If the interim results confirm a complete or near complete prevention of varices like they did in their phase 2 trial, they would have a compelling argument for conditional approval, likely with another post-market confirmatory phase 3 trial. Almost 50% of patients that develop esophageal varices die within a year, and the varices are extremely costly to treat. So eliminating the significant and imminent threat of death is the compelling benefit. The company is in solid financial shape with enough cash runway to complete their pivotal trial by 2025. They also have the backing of a billionaire investor who is also their Chairman of the Board. Additionally, their drug demonstrated promising results in cancer, psoriasis, and atopic dermatitis which could lead to a label expansion once they are approved. The market cap of the company is sitting around $225 million despite the near certainty of a positive interim trial readout within the next 8 months, which could translate into billions within that time frame. The company is not alone in the space and has 2 other competitors with oral galectin-3 antagonists. Galecto Bioscience (NASDAQ: GLTO) announced they were scrapping their cancer drug, which had a 60% response rate after three months, to focus on NASH. GLTO had a failed trial in idiopathic pulmonary fibrosis because of their drug’s poor tolerability, which has forced them to seek strategic alternatives with a focus on liver disease. As a result, their development timelines for MASH are in flux. Galecto’s small molecule approach to inhibiting intracellular galectin-3 is the likely culprit for their drug’s poor tolerability and its more likely large molecules which target extracellular galectin-3 will succeed. Bioxytran Inc. (OTCMKTS: BIXT) has the most technologically advanced oral galectin antagonist that completed phase 2 trials in standard risk COVID-19, but the company is underfunded and therefore moving forward cautiously. Both Bioxytran and Galectin Therapeutics are developing larger molecules compared with Galecto and both their drugs have been found to be safe as opposed to Galecto. Bioxytran’s additional benefit is that their drug doesn’t require intravenous administration. Their clinical trials in NASH or cancer are dependent upon them finding a partner or a couple million dollars to get a shot at a number of multibillion dollar opportunities. Management indicated that the quickest way to approval was a COVID-19 regulatory approval and then proceeding with the label expansion. While the company boasts impressive technology and experienced management, they don’t have the resources to prove their technology for all these indications yet. It's for these reasons that the stock should remain high on peoples watch lists—in case they get funding. Thyroid Hormone Agonists Viking Therapeutics (NASDAQ: VKTX) is the largest pure play MASH company measured by market capitalization with a number of molecules in phase 2 or 3 development. Their leading drug candidate, VK2809, is a THRβ agonist. They also have a dual agonist for both the GLP-1 hormone and glucose-dependent insulinotropic polypeptide (GIP), VK2735. Clinical trials for VK2735 have been highly successful making it a darling with a market cap of $7.56 which exceeds the market cap of MDGL that has an approved MASH drug that also targets THRβ. Viking’s VK2809 targets non-alcoholic steatohepatitis (NASH) and fatty liver. It aims to reduce liver fat, preventing inflammation, damage, and potential progression to cirrhosis. Clinical trial results for VK2809 include significant weight loss (up to 14.7% of baseline body weight) and improvements in liver fat content. Notably, 85% of VK2809 patients experienced a >30% decrease in liver fat by week 12, correlating with improved histology. At least 88% of participants lost at least 10% weight loss versus 4% for placebo. The company is also innovating for their next generation, orally administered NASH drug, which had positive phase 1 trial results. Other Approaches CanFite Biopharma’s (NYSE: CANF) lead drug candidate, namodenoson, is an A3 adenosine receptor (A3AR) antagonist, but what makes them stand out from the crowd is their platform technology that has the ability to screen targets in both the inflammatory and tumor micro-environment. It is also the only drug in the MASH space that is taken orally once a day. Both inflammatory and cancerous cells are overexpressed with A3AR which makes them an ideal target in MASH and liver cancer. The company completed both phase 2 and 3 studies for other indications such as liver cancer, so the favorable safety profile is well established in hundreds of patients. MASH study results showed a linear reduction in weight over time, a reduction in liver fat measured by proton density fat fraction (PDFF) on magnetic resonance imaging, validation of blocking the A3AR receptor, and the liver protective effect of the drug manifested by a reduction in hepatic inflammation. The company has a favorable status with both the EMA and FDA which could lead to a conditional approval. Their platform technology includes other large-market disease indications including psoriasis, pancreatic cancer, liver cancer, and erectile dysfunction. The company also has 6 major drug partners and the potential to earn $130 million on regulatory and sales milestones for their 2 pivotal phase 3 assets. With a compressed market cap of $10 million which is trading barely over their cash and the potential of regulatory approval within the next 1.5 years, it's easy to see how this biotech could translate into an extraordinary investment if it achieves regulatory approval. The company has a solid management team with a low burn rate which means they are less likely to dilute because their interests are aligned with shareholders. This rounds out the top 6 MASH companies with the best risk to reward ratio. Disclaimers: The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, assumptions, objectives, goals, assumptions of future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements, indicating certain actions & quotes; may, could or might occur Understand there is no guarantee past performance is indicative of future results. Investing in micro-cap or growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or due to the speculative nature of the companies profiled. RazorPitch Inc is responsible for the production and distribution of this content. RazorPitch is not operated by a licensed broker, a dealer, or a registered investment advisor. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. RazorPitch Inc authors, contributors, or its agents, may be compensated for preparing research, video graphics, and editorial content. RazorPitch Inc has not been compensated to produce and syndicate this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 markrmckelvie@gmail.com Company Website http://RazorPitch.com

April 22, 2024 06:00 AM Eastern Daylight Time

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Capturing Consumer Spending on Health Care with XLV

Select Sector SPDR

With consumer spending on health care continuing to increase, the Health Care Select Sector SPDR Fund ( XLV ) provides an opportunity for investors to leverage this trend. XLV tracks health care stocks within the S&P 500 Index, offering broad exposure to core companies in the U.S. healthcare sector. The fund's top holdings* are comprised of market leaders across several sub-sectors of healthcare including companies such as Eli LIlly & Co (11.34%), Unitedhealth Group (8.36%), Johnson & Johnson (6.96%), Merck & Co (6.11%), AbbVie Inc. (5.87%), Thermo Fisher Scientific (4.10%), Abbott Laboratories (3.61%), Danaher Corp (3.00%), Pfizer (2.86%), and Amgen (2.78%). Growth Drivers in the Healthcare Sector As the health care sector continues to grow, these companies are well-positioned to benefit from increased consumer spending. The growth history in this sector has been driven by several factors, including a rise in chronic diseases, an aging population, and advancing medical technology. Total spending on health care rose from 16% of GDP in 2007 to an estimated 18% in 2023. Simultaneously, the total GDP has risen nearly 70% in that time, from 14.47 trillion in 2007 to 25.5 trillion in 2022. Investing in XLV offers a diversified way to capture steady consumer spending on health care. By investing in the health care market in a broad way, the ups and downs of a particular big name in the sector are mitigated by the exposure to other healthcare companies. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. *Holdings, Weightings & Assets as of 3/31/24 subject to change DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007449 EXP 5/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

April 22, 2024 05:00 AM Eastern Daylight Time