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Market Alert: Silexion Therapeutics (NASDAQ: SLXN) Sees Record Volumes Following Breakthrough Preclinical Data for SIL-204

Global Markets News

Shares of Silexion Therapeutics (NASDAQ:SLXN) are seeing significatnly today after the company announced promising new preclinical data for its next-generation siRNA candidate, SIL-204. The stock saw a significant initial of price spike of over 50% in pre-market activity as investors responded to the latest developments in Silexion's RNA interference (RNAi) platform, which targets KRAS-driven cancers. As of now, volume is at record highs, currently standing at over 50 million shares today. The company revealed that SIL-204, an extended-release microparticle formulation, demonstrated substantial tumor reduction and necrosis in mouse models of pancreatic cancer bearing the KRAS G12D mutation—one of the most common mutations found in pancreatic cancer patients. This latest data builds on a string of recent successes for Silexion, including its September 24 announcement of results from the Phase 2 trial for its first-generation product, LODER™, which showed significant improvements in tumor resectability among non-resectable pancreatic cancer patients. Alongside the new preclinical results, Silexion has recently reported plans to begin toxicology studies for SIL-204 in preparation for Phase 2/3 clinical trials expected to commence in the first half of 2026. The company is also expanding the application of its siRNA technology to colorectal cancer models, reflecting its broader ambitions to target multiple KRAS-driven cancers, which are notoriously difficult to treat with conventional therapies. While stock price has pulled back since premarket, The spike in Silexion’s market activity as marked by these record high volumes (according to market data) may highlight the growing market interest in the company’s novel approach to tackling cancers with high unmet medical needs, particularly its focus on KRAS mutations, which are common across a variety of aggressive cancers, including pancreatic and colorectal cancer. Silexion’s continued momentum in the precision oncology space potentially positions it as a leading player in the development of next-generation RNAi therapies. With its promising pipeline and recent positive developments, the company seems to be gaining attention as it advances toward clinical trials that could offer new hope for patients battling some of the deadliest cancers. Click here to read Silexion's full announcement *** This update is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [https://justpaste.it/ab9dn/pdf]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news and developments related to innovative companies as detailed in the full documentation and it is thus subject to conflicts of interest. Contact Details News Coverage ronald@futuremarketsresearch.com

October 01, 2024 11:47 AM Eastern Daylight Time

Velocity Global Named a Leader in NelsonHall’s Global Employer of Record (EOR) Evaluation for the Fourth Time in a Row

Velocity Global

Velocity Global, the world’s expert on work, announced today that it was positioned as a leader in the 2024 Vendor Evaluation & Assessment Tool (NEAT) for global EOR services by NelsonHall. The report recognizes Velocity Global for both its ability to deliver immediate customer benefits as well as its capabilities to meet future customer needs. This marks the fourth time in a row that Velocity Global has earned this distinction, solidifying its position as a trusted partner for companies expanding their global presence. "Deploying a global workforce is extremely complex, as companies need to navigate a maze of varying regulations, compliance needs, and talent expectations in different countries," said Jeanine Crane-Thompson, Principal Analyst at NelsonHall’s HR & Talent Transformation practice. "Velocity Global’s blend of strategic R&D investments and compliance expertise has transformed them into a critical partner for companies looking to accelerate global growth. Their comprehensive EOR solution allows organizations to focus on their expansion goals without the burden and potential risks of logistical and legal complexities." As a trailblazer in global workforce solutions, Velocity Global empowers companies to hire, manage, pay, and retain talent, anywhere in the world. Over the years, Velocity Global has evolved from offering a point solution to being a strategic partner to its customers as they execute on their global growth plans. Velocity Global’s powerful combination of its self-service Global Work Platform and its deep legal and HR expertise ensures seamless compliance, no matter how complex the jurisdiction. Both employers and employees benefit from a frictionless, user-friendly experience. In its 2024 report, NelsonHall highlights several strengths that contributed to Velocity Global’s positioning as a leader, including: Mature EOR market provider: Velocity Global offers a compliant, integrated EOR solution that enables multinational companies to confidently hire across borders. Technology roadmap: Velocity Global’s roadmap is centered on AI-driven enhancements, expanded platform integrations, and robust self-service functionality. Competitive service offerings beyond EOR: Velocity Global offers an array of services beyond EOR, including global benefits, immigration support, pensions, equity management, and office space logistics. ”The ability to hire anyone, anywhere is a huge differentiator as companies expand across geographies and tap into underutilized talent pools,” says Francoise Brougher, CEO of Velocity Global. “To simplify and streamline this process for customers, we invest in our technology. This, coupled with our extensive in-country and compliance expertise, means customers can have peace of mind and focus on growing their business.” This latest recognition reinforces Velocity Global’s unwavering commitment to empowering businesses with the tools and expertise to navigate the complexities of the global workforce landscape and drive sustained growth. To learn more about what sets us apart, download the report [ here ]. For more information on how Velocity Global makes opportunity borderless for people everywhere, visit www.velocityglobal.com. About Velocity Global Velocity Global gives you the power to build your team everywhere—combining seamless technology and local expertise in 185+ countries. We make it simple to compliantly hire, pay, manage, and retain talent anywhere. With Velocity Global, the world is yours. About NelsonHall NelsonHall is the leading global analyst firm dedicated to helping organizations understand the 'art of the possible' in digital operations transformation. With analysts in the U.S., U.K., Continental Europe, and Asia, NelsonHall provides buy-side organizations with detailed, critical information on markets and vendors (including NEAT assessments) that helps them make fast and highly informed sourcing decisions. And, for vendors, NelsonHall provides deep knowledge of market dynamics and user requirements to help them hone their go-to-market strategies. NelsonHall's analysis is based on rigorous, primary research, and is widely respected for the quality and depth of its insight. Media Contact: press@velocityglobal.com Contact Details Media contact +1 720-650-4348 press@velocityglobal.com Company Website https://velocityglobal.com/

October 01, 2024 07:47 AM Pacific Daylight Time

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How Cosmos Health’s Acquisition Of Almost 100-Year-Old Company, Adding To Capabilities Like Contract Manufacturing, Could Generate Over $10 Million In Annual Gross Profit

Benzinga

By James Blacker, Benzinga Global healthcare group Cosmos Health (NASDAQ: COSM) has potentially positioned itself for growth through its acquisition last year of Cana Laboratories, a Greek pharmaceutical company with nearly a century of expertise. As Cosmos’ new manufacturing arm, Cana brings a wealth of synergies, potentially enabling the company to control its own production, from pharmaceuticals to nutraceuticals. Cana Laboratories: A Century Of Expertise Founded in 1928, Cana Laboratories has earned its name in the pharmaceutical industry over nearly a century, having partnered with companies such as AstraZeneca (NASDAQ: AZN), Merck (NYSE: MRK), Janssen, Nestlé (OTC: NSRGY), Unilever (Unilever), Viatris (NASDAQ: VTRS) and Procter & Gamble (NYSE: PG). In recent years it has also worked with major firms in the medtech space, namely Medtronic (NYSE: MDT) and Stryker (NYSE: SYK). Cosmos acquired Cana in July of last year for around $1.67 million – a heavy discount compared to Cana’s $10 million valuation at the time, according to the company. As such, Cosmos expects to record a substantial gain on the purchase of what it now considers to be its crown jewel asset. The acquisition of Cana equips Cosmos with in-house manufacturing capabilities, bringing significant vertical integration and providing greater control over quality and costs. Cosmos can now use Cana’s facilities to manufacture its portfolio of generic medicines, including treatments for diabetes, cholesterol, respiratory and cardiac conditions, as well as its proprietary nutraceutical brand, Sky Premium Life. The acquisition has moreover added several brands to Cosmos’ portfolio, including antiseptics like C-Sept, the organic infant care line biobebe and dermocosmetics such as Eleon Cosmetics. New Facility To Scale Production Furthermore, Cosmos now owns Cana's 54,000 sq. ft. production facility in Athens. Certified by the European Medicines Agency and with a Good Manufacturing Practice license, this facility enhances Cosmos’ production capabilities, creating opportunities for potentially lucrative contract manufacturing agreements. Cosmos has invested some $5.5 million in Cana since the acquisition. The investment includes upgrading the Athens facility with new machinery, equipment, IT infrastructure and quality management systems. These investments will enable the company to manufacture a wide range of pharmaceuticals at scale, such as tablets, capsules, syrups, sprays, creams, gels and ointments. The company announced in July this year that it completed the first phase of this upgrade. At full capacity, which Cosmos says will be reached by the end of 2025, the facility is expected to generate over $10 million in annual gross profit. This stands in contrast to Cosmos’ current market cap of about $15 million as of Sept. 27. Contract Manufacturing: A High-Margin Growth Driver With its enhanced manufacturing capacity, Cosmos aims to accelerate the growth of its contract manufacturing business. In July, the company announced that it signed agreements with Provident Pharmaceuticals and Humacology to manufacture 5,020,000 units of medicines and up to 500,000 CBD units. Cosmos says its contract manufacturing business has very high margins thanks to minimal costs, most of which are borne by clients. The company, therefore, expects the newly signed deals to be highly profitable. Moreover, with less than 20% of its production capacity being utilized, there is plenty of room to sign additional contracts. Further down the line, if the facility reaches full capacity, Cosmos is prepared to initiate a second phase of the expansion to further boost capacity and gross profits beyond the projected $10 million from phase 1. Cosmos Health says it is confident that the acquisition of Cana Laboratories positions it for substantial growth. With its new in-house production capabilities, the company can boost efficiency and secure high-margin contract manufacturing agreements. Interested investors may want to watch for announcements of further contract manufacturing agreements as Cosmos seeks to fully utilize its production capacity. Featured photo by Testalize.me on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

October 01, 2024 09:30 AM Eastern Daylight Time

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Forum Health Launches Revolutionary PNOĒ Metabolic Device Transforming Weight Management, Fitness and Longevity

Forum Health

Forum Health, a premier provider of personalized integrative and functional medicine, announces the launch of the PNOĒ metabolic analysis device, offering precise insights into metabolic, heart, lung, and cellular health for personalized wellness. Now available in Forum Health’s Madison and Fond du Lac, Wisconsin clinics, the PNOĒ uses a data-driven approach to weight management, fitness, and longevity optimization. Schedule a PNOĒ assessment here: Fond du Lac or Madison. Julie Heyrman, MD: "We’re thrilled to bring this advanced technology to our patients in Wisconsin. The PNOĒ allows us to better tailor health solutions that address the root causes of weight gain, fatigue, aging, and cardiovascular risk." Through using only breath, the PNOĒ provides a comprehensive metabolic analysis on how effectively the body burns calories, the efficiency of the heart and lungs, and overall cellular performance. Patients receive personalized health plans tailored to their unique metabolic profile for improved wellness and disease prevention. Key Benefits of PNOĒ Metabolic Analysis: Precision Weight Management: Analyzes metabolism to optimize workouts, calorie intake, and macronutrient balance for sustainable weight management. Endurance Enhancement: Measures the efficiency of heart, lungs, and cells, identifying limiting factors and providing a customized plan to overcome them. Longevity Optimization: Calculates VO2 max, cellular health, and metabolic efficiency—key predictors of lifespan and well-being. Early Detection - Detects early risk factors for heart, lung, and metabolic conditions, empowering proactive health steps. Phil Hagerman, CEO: “Forum Health is committed to bringing the most advanced technologies to our patients, and the PNOĒ device represents a new frontier in personalized healthcare. By offering precise metabolic insights, we can create tailored health plans that drive better outcomes for the health issues most affecting our patient's overall well-being.” About PNOĒ PNOĒ is a state-of-the-art metabolic analysis device that provides comprehensive assessments of heart, lung, and cellular fitness through breath analysis. Learn more at pnoe.com. About Forum Health, LLC 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 Britt Wittelsberger +1 410-852-0738 bwittelsberger@forumhealth.com Company Website https://forumhealth.com

October 01, 2024 08:50 AM Eastern Daylight Time

MediVera Compounding Pharmacy™ Expands into 18 States Across Five Regions in 2024, Now Offers Dozens of Personalized Medicine Options

MediVera

MediVera Compounding Pharmacy™, a leader in personalized medicine since 1999, announced today that it has officially been licensed to serve residents in 18 new states across the West, Southwest, Southeast, Midwest, and Northeast regions in 2024. The licenses allow MediVera to fill compounding prescriptions—including semaglutide and tirzepatide—throughout these states. This expansion broadens the company’s geographical reach, reflecting its commitment to providing personalized compounding services to prescribers and patients nationwide. The new states include: West Region: Colorado, Idaho, Montana, Utah, Washington, Wyoming Southwest Region: Arizona, New Mexico, Oklahoma Southeast Region: Georgia, North Carolina, South Carolina, Tennessee, Virginia, West Virginia Midwest Region: South Dakota Northeast Region: Connecticut, Maine The licenses were issued between January 24, 2024, and August 13, 2024, by the respective State Boards of Pharmacy following rigorous application and compliance processes that require MediVera to meet or exceed governmental regulations and recommendations. MediVera is PCAB Accredited in both sterile and non-sterile compounding, certifying ethical and quality standards met by only 1% of compounding pharmacies nationwide. Prescribers and patients in these states are now welcome to use MediVera’s services, effective immediately. “We are absolutely thrilled with the opportunity to do business in these new states,” said MediVera CEO Bradley McCloskey, PharmD. “MediVera has been dedicated to changing lives with the industry standard in personalized medicine since it was founded by my father over 20 years ago. Bringing that simple mission to states across the country—and now to these additional 18 states—is a dream come true.” This growth coincides with an increased interest in compounded medications, including hormone replacement therapy and solutions for men’s and women’s health. MediVera has responded with an ongoing nationwide expansion effort, growing its footprint to include 37 states, with more licenses expected before the end of the year. About MediVera Since its inception in 1999, MediVera Compounding Pharmacy™ (formerly University Compounding Pharmacy) has been dedicated to providing personalized medicine. With a focus on quality and innovation, MediVera Compounding Pharmacy™ continues to set industry standards, offering tailored solutions to meet the unique needs of healthcare providers and patients. MediVera Compounding Pharmacy™ is currently licensed in and ships to the following 33 states: AZ, CN, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NY, OH, PA, RI, SC, SD, TN, VA, VT, WA, WI, WY. Contact Details MediVera Compounding Pharmacy™ Laurie Malseed +1 937-242-0430 laurie@mediverarx.com Company Website https://mediverarx.com/

September 26, 2024 09:00 AM Eastern Daylight Time

Independent Living And Safety: How LogicMark's Innovations Are Helping To Address The Needs Of An Aging America

Benzinga

By Gerelyn Terzo, Benzinga Check out LogicMark’s investment deck here. In America, more than 10,000 Baby Boomers reach the milestone age of 65 each day. By 2040, 25% of the American population will be over the age of 65. Meanwhile, senior citizens are choosing to live life independently more than ever before, a shift that has gained momentum in the wake of the pandemic. These days, nearly three-quarters (70%) of Americans shudder at the thought of being admitted into a nursing home, a Gallup poll revealed. Additionally, almost two-thirds of families would hesitate to admit a loved one to a nursing home facility. However, living independently introduces a host of other challenges that must be overcome. While emergency and safety needs have evolved over the past several decades, personal safety solutions often lag behind and don’t keep pace with modern technological standards. This has an impact on vulnerable communities, as well as the “sandwich generation” – many of whom are caring both for their own children as well as their aging parents. Why Seniors Are Vulnerable To Falling In reality, the leading cause of injury and death for senior citizens over the age of 65 is falling, and with more of the aging population living independently, the trend is only getting worse, according to the U.S. Centers for Disease Control and Prevention (CDC). In fact, of the roughly 58 million Americans age 65 or older, one in four report experiencing a fall, based on historical data from the CDC, a growing problem they admit can be prevented. Dr. Esiquio Casillas, Senior Vice President and Chief Medical Officer for the AltaMed Health Services Program of All-Inclusive Care for the Elderly, explained the cause, saying, “That’s because aging affects our muscle strength and flexibility, making it more challenging to maintain balance and stability. Older adults are also more likely to have chronic conditions that can affect their mobility, coordination and overall stability. Plus, age-related vision changes and hearing loss can make it harder to navigate and identify potential hazards.” Recognizing these concerns, LogicMark (NASDAQ: LGMK), with nearly two decades in the personal safety products market, has developed an entire suite of solutions, including personal emergency response systems (PERS), health communications devices and internet-of-things (IoT) technologies for a connected care platform. LogicMark says its technology harnesses data to identify risks while anticipating needs and protecting data privacy. It carries the potential to reverse a troubling and dangerous trend of death from accidental falls. Considering the growth that the senior medical alerts/PERS market is set to experience, with the market opportunity projected to reach $17.26 billion by 2028 – reflecting a compound annual growth rate of 10.6% – LogicMark could be strategically positioned to capitalize on this trend. LogicMark’s Business Evolution Since its founding in 2006, LogicMark has become a leader in personal safety. Early in its inception, the company relied heavily on reactive medical alert hardware, products that generated one-time revenue and were predominantly targeting the business-to-government (B2G) market, which LogicMark says it has not only penetrated but is strong in despite fierce barriers to entry. Since 2021, the company’s transformation has been in full gear, coinciding with the appointment of CEO Chia-Lin Simmons, who remains at the helm. LogicMark reports that it has since expanded from a one-time revenue model to one that includes recurring subscription revenue with a very good lifetime value. Its latest products exist in white-hot areas such as AI, software-as-a-service and mobile applications, while it has also broadened its reach to include business-to-business (B2B) and business-to-consumer (B2C) channels. The LogicMark ecosystem integrates proprietary AI and machine learning technologies, facilitating ongoing connectivity and scalability. How LogicMark’s Products Can Be A Lifeline In Distress LogicMark has no shortage of products and solutions from which senior citizens and others can choose that could serve as a lifeline in times of distress. While LogicMark offers numerous products and services, here are a couple that are uniquely fit for seniors: Freedom Alert Mini: The newest in its line of mobile medical alert devices, Freedom Alert Mini brings revolutionary technology to medical alert devices. 24/7 monitoring means this device will always reach help and ensure wearers receive critical assistance. Fall detection will alert emergency services even when the fallen can't speak. GPS location services allow caregivers to monitor device location at all times. Caregivers can set geofencing boundaries to receive alerts when those under their care may wander. The Care Village app provides ultimate reassurance as a hub for emergency alerts, device status and geofencing boundary management. Guardian Alert 911 Plus: Guardian Alert 911 Plus is a 4G LTE technology that gives wearers peace of mind to travel anywhere within range of a cellular network. An industry-leading battery life means Guardian Alert 911 Plus only needs to be charged every 3-6 months, based on battery monitoring settings. LogicMark brought two-way voice communication to medical alert device technology. Guardian Alert 911 Plus can be worn on a lanyard, in a belt clip or on a wrist strap. This device is a one-time purchase, requiring no monthly monitoring fees. Aster: For aging adults who have a cell phone and are not ready for a traditional medical alert device, LogicMark offers Aster, a personal safety app that connects directly to a monitoring service to ensure the user's safety. In an emergency, a swipe will immediately connect them to monitoring professionals who will stay on the line and dispatch emergency services to help. A press and hold will allow all aging adults to arm the app when they don't feel safe and call help when they release. The follow me feature allows users to schedule events or appointments that they would like a check-in after, to make sure they have left safely. The Bluetooth button can be clipped to a keychain or purse to call emergency services immediately when help is needed. Freedom Alert Plus: Freedom Alert Plus is an in-home, Wi-Fi-powered medical alert device. LogicMark reports that it is the first of its kind with a touch screen and fall detection, making the device the ultimate safety companion for around the home and yard. 24/7 monitoring means emergency professionals are always available to dispatch help when wearers need it. Care Village provides caregivers with peace of mind, knowing they will always receive alerts when their loved one needs assistance. They can monitor device battery life and Wi-Fi connection to make sure Freedom Alert Plus will connect to emergency services. The issues around personal safety and independence are not going to disappear by themselves. Investors who are interested in participating in this digitization of the personal safety market can check out LogicMark’s investment deck here. Featured photo by Oppo Find X5 Pro on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 24, 2024 08:45 AM Eastern Daylight Time

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CompleCure Partners with AGC Biologics’ Chiba Site to Develop Advanced Anti-Cancer Therapeutic Using Pioneering AMDC Technology

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today the company entered into a strategic service agreement with CompleCure. The partnership focuses on developing the manufacturing process for a novel anti-cancer therapeutic, which uses Antibody Mimetics Drug Conjugate (AMDC) technology—a groundbreaking advancement in cancer treatment. AGC Biologics is developing the manufacturing process for the protein component of this new therapeutic at its facility in Chiba, Japan. The AMDC technology represents a significant evolution of Antibody Drug Conjugate (ADC) therapy, offering a potentially promising new approach to cancer treatment by combining a mimetic protein structure with a chemically synthesized drug specifically designed to target and destroy cancer cells. The therapeutic being developed by CompleCure aims to revolutionize breast cancer treatment. It is designed to achieve complete remission with minimal side effects, significantly improving patient outcomes. The protein component, which is the focus of AGC Biologics' efforts, features a complex tetrameric structure that demands advanced technologies in microbial expression for successful process development and manufacturing—an area where AGC Biologics Chiba has unparalleled expertise. “AGC Biologics Chiba and our scientists are experts in working with complex proteins and the latest technologies. For this reason, we are an ideal CDMO site to partner with CompleCure on this innovative treatment,” said Jun Takami, General Manager, AGC Biologics Chiba Facility. “We look forward to working side by side with the CompleCure team to develop this new therapeutic that could have a revolutionary impact on breast cancer patients across the globe.” CompleCure selected AGC Biologics as its partner based on the company’s 30-year track record as a leading CDMO, its ability to rapidly propose innovative development solutions, and its flexible production capabilities. The two companies plan to continue manufacturing the protein component at AGC Biologics' Chiba site, ensuring a seamless transition to production for further steps once the process development is completed. This collaboration marks a significant milestone in the path toward the commercialization of AMDC-based therapeutics. By combining AGC Biologics’ development and manufacturing capabilities with CompleCure's innovative therapeutic approach, the two companies hope to bring this promising treatment to market, ultimately contributing to the improvement of quality of life (QOL) for cancer patients worldwide. For more information about AGC Biologics Chiba, visit www.agcbio.com/facilities/chiba. To learn more about AGC Biologics’ global CDMO services go to www.agcbio.com. About CompleCure CompleCure is a start-up developing innovative pharmaceuticals by utilizing cutting-edge biotechnology. We own the intellectual property rights to the “Cupid-Psyche System,” utilizing the high affinity and strong binding of proteins and vitamins. Cupid-Psyche System is one of the outcomes of the “Molecularly Designed Antibody Project,” a cutting-edge R&D support program led by the Cabinet Office and involving Japan Bioindustry Association, the University of Tokyo, Osaka University, Chugai Pharmaceutical Co., Ltd. and Fujifilm Corporation. The new breast cancer treatment for which AGC would develop manufacturing process under the announced strategic service agreement is the most advanced in development among the AMDC based therapeutics utilizing the Cupid-Psyche system. This therapeutics is being developed in cooperation with the University of Tokyo, Tohoku University, and Chiba University. We will open up new possibilities for fundamental treatment of cancer. 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 Team Members 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 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

September 23, 2024 04:58 PM Pacific Daylight Time

SBC Medical Group Holdings (Nasdaq: SBC) Claims First-Mover Advantage In Medical Services Franchise Model, Debuts On Nasdaq

Benzinga

By Gerelyn Terzo, Benzinga While it’s hard to put a price tag on time, it’s one of those commodities that healthcare professionals value highly. And yet, many physicians, including surgeons, are mired in administrative work, costing them valuable time that they could otherwise be spending on patient care. Fortunately, the medical field continues to see new innovations such as AI-powered diagnostics, surgery robots, wearables — and the rise of service organizations that shoulder the weight of otherwise mundane administrative tasks. As a result, healthcare professionals across medical segments have more options than ever to keep their operations running smoothly while optimizing performance. One company in the vanguard of this trend is SBC Medical Group Holdings (NASDAQ: SBC), a Tokyo-based medical services healthcare company with a history in the aesthetics space that specializes in solving the problems of medical care providers. SBC has its roots in providing management services to cosmetic treatment centers in Japan, an industry where demand is on the rise, fueled by procedures such as dermal fillers, botulinum toxin (botox) and eyelid surgery and more. Bringing A New Business Model To The Aesthetic Medical Industry SBC Medical’s business model brings the franchisee-franchisor model to a new industry. This model is one that is appreciated by many investors for its proven success in sectors like restaurants and now in healthcare, including medical clinics. SBC believes that as the pioneer of the franchise model in the global aesthetics medical industry, it enjoys a first-mover advantage. The company boasts a No. 1 leading position in Japan’s growing aesthetics medical industry, reporting that it generates stable and high-profit margins owing to the collection of ongoing franchise fees. This model involves franchisor-franchisee contracts or agreements between any of SBC ’s Japanese subsidiaries and medical corporations serving as the umbrella for a total of 218 clinic treatment centers in Japan, with 2 additional clinics located outside of the country. These beauty clinics, which operate under the Shonan Beauty Clinic brand, specialize in services ranging from breast augmentation and laser hair removal to cosmetic dental procedures and beyond. The administrative tasks associated with providing these kinds of medical services can be burdensome without proper support. Supporting Healthcare Professionals Through Management Services The comprehensive management services that SBC provides to franchise clinics run the gamut. Depending on the practice’s needs, SBC might handle its IT requirements, advertising and marketing needs (such as operating social media channels), hiring, payroll, reservations, staff housing and other such requirements. Additionally, SBC supports franchisee clinics in other ways, extending to the construction and design of clinics, procurement and resale of medical equipment and consumables, the provision of cosmetic products to patients, licensure/IP, customer loyalty programs and more. A common thread across these services is that they represent time-consuming activities that can take a toll on practice owners, interfering with their ability to give 100% of their attention to providing high-quality care to their patients. While the services may vary, the end goal is the same - to create greater efficiencies for the medical practice while saving healthcare professionals valuable time and streamlining their operations. As a result, the doctors can focus on what they do best - caring for patients. Importantly, SBC is not limited to any single medical specialization or jurisdiction. Since its inception, the company has expanded its footprint to provide high-quality services to medical corporations overseas, including its first clinic in Vietnam and the United States, respectively. SBC has just made its debut as a publicly traded company on the Nasdaq, giving investors an opportunity to participate in its growing total addressable market. Company And Market Dynamics SBC specializes in providing comprehensive management services to franchisee healthcare clinics. Incorporated in 2023, SBC believes it is well-respected in the industry, owing to the SBC management team’s two decades-plus of industry experience. For more than two decades, SBC CEO and Chairman Dr. Yoshiyuki Aikawa has been at the helm of Aikawa Medical Group, now known as SBC. He also served as president and director of the Japanese Society of Aesthetic Plastic Surgery, Harvard Medical School, PGA. SBC Chief Operating Officer Yuya Yoshida is a seasoned capital markets executive, with former stints at Rakuten Group Co, where he specialized in M&A at Mitsubishi UFJ Financial Group. With a combined 166 franchise clinics, SBC has already claimed the title of Japan’s biggest aesthetic medical group. While the company is in the midst of an expansion push, Japan is its maiden market, where it reports it has a demonstrated track record of success. It plans to continue to grow in Japan while pursuing new growth opportunities in the U.S. and Southeast Asia. Japan’s cosmetic surgery market has experienced steady growth. It is predicted to expand at a compound annual growth rate (CAGR) of 8.1% in the decade leading up to 2033 for a value of $41.6 billion, up from $19 billion in 2023. Meanwhile, the country’s medical aesthetics market was worth $2.6 billion as of last year and is growing at a CAGR of 13% in the current decade for a value of $9 billion by 2033. SBC’s Balance Sheet Investors who are interested in participating in the company’s growth story may find SBC ’s fundamentals interesting. For the fiscal year ended December 31, 2023, SBC’s revenues increased 11% to $193 million with EBITDA of $82 million and net income of $39 million. Revenues increased 27.72% to approximately $54.8 million with a net income of approximately $18.7 million for the three months ended March 31, 2024. The company has a balance sheet to help support its growth, with approximately $96 million in cash and cash equivalents as of March 31, 2024. SBC is not only providing quality comprehensive management services to medical corporations and expanding its Shonan Beauty Clinic brand but doing so profitably. SBC Medical Group Holdings began trading on the Nasdaq under the ticker symbol SBC on September 18 following a business combination with Pono Capital Two (Nasdaq: PTWO), a special purpose acquisition company (SPAC). Investors who would like to participate in SBC’s growth story now have the unique opportunity to do so in the stock’s early days of trading on the Nasdaq market. Featured photo by Bru-nO on Pixabay. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 20, 2024 08:25 AM Eastern Daylight Time

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MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing On Early Clinical Efficacy Demonstration For Neuropathic Pain In 2025

MIRA Pharmaceuticals, Inc.

By Meg Flippin, Benzinga MIRA Pharmaceuticals (NASDAQ: MIRA), the pre-clinical-stage pharmaceutical company focused on transforming the treatment of neuropathic pain and mental health disorders through scientific research and technological advancements, is making progress in its clinical development planning for Ketamir-2, its novel oral ketamine analog. So much so that the company said that, as part of its strategic development plan, it’s prioritizing early demonstration of Ketamir-2’s clinical efficacy. That could come as early as 2025 through innovative phase 1/2 study designs. What’s more, the company said it's on track for Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) in December 2024. "Our primary goal is to demonstrate efficacy in humans as quickly as possible," says MIRA Pharmaceuticals chairperson and CEO Erez Aminov. "By implementing specific study designs and leveraging our ongoing preclinical research, we aim to gather early evidence of clinical benefits, positioning our treatment as a transformative option for neuropathic pain." To bolster its approach to clinical and regulatory approval, MIRA said it brought on a consultant with expertise in navigating academia and regulatory bodies, including the Federal Drug Administration. The company said this addition demonstrates that it is serious about meeting the highest standards in clinical development and regulatory compliance. Ketamir-2’s Approach To Fighting Neuropathic Pain and Depression Ketamir-2 is an oral ketamine analog designed to be taken as a pill. It is being investigated for the treatment of neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDDSI) and PTSD. Unlike traditional ketamine, which requires intravenous administration, posing accessibility and safety challenges, Ketamir-2 could potentially simplify and improve the treatment experience. The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression, cancer-related neuropathic pain and diabetic neuropathy. These conditions often have limited treatment options and significant patient populations needing effective therapies. Neuropathic pain alone is a big market, poised to reach over $14 billion by 2034, growing at a CAGR of 5.7% from now until then. Driving demand for drugs to relieve pain is an aging population in the U.S. and an increase in chronic diseases. Collaborating To Speed Time To Market To get testing underway, MIRA Pharmaceuticals said it is collaborating with Formulex, a nano-technology-based drug delivery company, to develop ways to deliver Ketamir-2. The two focus on a spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience. A deterrent to more people using ketamine to treat mental health issues and chronic pain is the delivery. Traditional ketamine treatment for depression requires a Risk Evaluation and Mitigation Strategy (REMS) protocol due to its potential for abuse and severe side effects. This involves strict regulations, including requiring intravenous administration under medical supervision, making it less accessible and more costly for patients. In contrast, Ketamir-2, as an oral formulation, aims to provide a more convenient and less intimidating treatment option. By reducing the need for medical supervision and hospital visits, MIRA Pharmaceuticals says Ketamir-2 could enhance patient compliance and decrease overall treatment costs. Phase I Trial Kicking Off Soon Through the phase I/II study designs MIRA is focused on demonstrating the clinical activity in treating neuropathic pain and potentially other neurologic conditions. The idea is to gather data that can drive faster decision-making and potentially expedite patient access, the company said. The phase 1 clinical trial is slated to kick off in the first quarter of 2025 and will be used to assess safety, tolerability and pharmacokinetics in humans. MIRA says that lays the groundwork for subsequent efficacy studies. MIRA collaborates with international academic research institutes to refine and enhance its clinical development strategy. “We are excited to move smoothly forward with our IND-enabling pre-clinical studies towards Phase I trials, which are designed to provide critical insights into the safety and pharmacokinetic profile of our candidate,” said Dr. Angel, chief scientific advisor at MIRA Pharmaceuticals. “This trial is a pivotal step in our journey to bring novel treatment options for neuropathic pain to patients, and we are committed to executing it with the highest scientific and regulatory standards.” Featured photo by Towfiqu barbhuiya on Unsplash. MIRA Pharmaceuticals, Inc., is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (“PTSD”). The statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2 and MIRA-55. Any forward-looking statements are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michelle Yanez +1 305-340-8988 Myanez@mirapharma.com Company Website http://www.mirapharmaceuticals.com/

September 19, 2024 09:00 AM Eastern Daylight Time

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