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Quest Diagnostics (NYSE: DGX) And Mainz Biomed (NASDAQ: MYNZ) Team Up To Commercialize ColoAlert Early Cancer Detection Screening In The U.S.

Benzinga

By Meg Flippin, Benzinga Mainz Biomed N.V. (NASDAQ: MYNZ), the molecular genetics diagnostic company specializing in the early detection of cancer, is moving closer to commercializing its early colorectal cancer detection screening ColoAlert® in the U.S. by inking deals with Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services. As part of the agreements, Mainz Biomed said Quest Diagnostics will provide clinical trial and laboratory services to support its ReconAAsense Food and Drug Administration pivotal study of ColoAlert. The clinical trial is slated to kick off next year with up to 15,000 patients. If ColoAlert gets the nod from the U.S. FDA, it will be able to target the millions of Americans at risk of colorectal cancer. Mainz has said its commercial strategy is to establish scalable distribution in the U.S. through a collaborative partner program with regional and national laboratory service providers. The recent strategic alliance with Thermo Fisher Scientific (NYSE: TMO), a global leader in life sciences with annual revenue exceeding $40 billion, represents a monumental step forward in transforming cancer prevention in the United States, says Mainz. This partnership harnesses Thermo Fisher's extensive expertise and state-of-the-art infrastructure to drive innovation in healthcare solutions. Adding further depth to this initiative is the collaboration with Quest Diagnostics, a leader in advanced testing and sampling technologies. Quest Diagnostics offers a broad range of services, including routine blood work, genetic and molecular testing and specialized diagnostic services for various diseases, such as cancer, cardiovascular conditions and infectious diseases. Mainz reports that Quest Diagnostics is widely recognized for its national network of laboratories, extensive patient service centers and cutting-edge technology that ensures accurate and timely test results. As a significant player in the healthcare industry, particularly in diagnostic testing and sampling, Quest Diagnostics serves millions of patients and healthcare providers annually, making it a critical component in advancing precision and scalability in early cancer detection and prevention. With $8 million in funding dedicated to expediting FDA approval, this initiative aims to rapidly advance critical milestones, laying the groundwork for massive expansion. Together, Mainz believes these partnerships are poised to catalyze a sweeping transformation in public health outcomes, creating a tidal wave of innovation and economic growth that will ripple across the healthcare landscape. Readying ColoAlert For Potential U.S. Debut In addition to supporting the clinical trial, Mainz said Quest Diagnostics has a semi-exclusive right to market ColoAlert in the U.S. for an eighteen-month period. If exercised, this option will allow Quest Diagnostics the opportunity to offer the product to multiple channels, including physicians, health systems, hospitals, health plans, employers and consumers, reports Mainz Biomed. “We are excited by the opportunity to collaborate with Quest Diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Teaming with Quest Diagnostics during our critical FDA Study will be key to our long-term success.” Encouraging Trial Results ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer cases, often in the very early stages of the disease. Based on recent trials, Mainz Biomed says ColoAlert’s sensitivities exceeded 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development, reports Mainz. Big Addressable Market It's a big market for Mainz Biomed to address, given colorectal cancer is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The U.S. Preventive Services Task Force recommends that screening with stool DNA tests be conducted once every three years, starting at age 45. As it stands, 71% of the diagnoses made are in the later stages of the disease. But if it's caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in ten colorectal cancers are spotted at the early stage. Each year in the U.S., 16.6 million colonoscopies are performed, yet about one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4 billion total market opportunity in the U.S., according to estimates compiled by Mainz Biomed. ColoAlert, if approved in the U.S., may help rectify that lack of timely screening. After all, Mainz Biomed says its detection system is less invasive than ColoGuard, the leading at-home test in the U.S., because it requires very small samples to test. It’s one of the reasons the company boasts 98% patient satisfaction in Germany. ColoAlert is also easy to use, which should be a big driver of adoption. Within five minutes your sample is collected and packaged and on the way to the lab. Patients receive a kit in the mail that includes instructions, a stool collector and a shipping label to return the kit to their local lab for testing. Patients receive the results in a few days. Mainz Biomed wants to bring its ColoAlert early cancer screening test to the U.S., and it is inking deals and readying clinical trials to achieve that. Its agreements with Quest Diagnostics put it one step closer. Stay tuned in 2025 – there may be lots more to come from Mainz Biomed on its path to commercializing ColoAlert in the U.S. and beyond. Featured photo by National Cancer Institute 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

December 20, 2024 08:30 AM Eastern Standard Time

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PathAI Launches AIM-IHC Breast Panel on AISight® Platform to Streamline Breast Cancer Biomarker Quantification and Improve Pathologist Efficiency

PathAI

PathAI, a leader in AI-powered pathology solutions, today announced the launch of the AIM-IHC Breast Panel, a set pf advanced AI-assisted, algorithms designed to quantify critical breast cancer biomarkers—HER2, ER, PR, and Ki-67. Available now on the AISight® Image Management System (IMS), this comprehensive panel provides partners with accurate, consistent scoring, enhancing precision and streamlining workflow efficiency. Adding to the existing AIM-HER2 Breast solution, this consolidation of critical breast cancer biomarker algorithms into a single, pathologist-centric image management system directly addresses the need for standardized, reliable quantification assist tools to support pathologists. PathAI’s AIM-IHC Breast Panel is designed to address key challenges in breast cancer biomarker quantification, particularly the need for precise and reproducible assessment. The panel provides accurate, consistent, zero-click scoring for HER2, ER, PR, and Ki-67 directly from routine immunohistochemistry (IHC) images. With automated tissue segmentation and detection of on-slide controls, the panel classifies areas of invasive versus non-invasive cancer and provides overlays to support algorithmic scoring. This breast cancer-centric panel is designed for a pathologist-assist workflow, allowing users to better differentiate regions of interest, improve the accuracy of invasive cancer segmentation, and streamline tedious scoring processes. The AIM-IHC Breast Panel is the latest addition to PathAI's expanding suite of AI-powered solutions on the AISight® IMS. AISight serves as a central hub for managing pathology images, enabling seamless integration of various AI-driven tools for pathology labs. By centralizing workflows and offering a growing portfolio of applications, PathAI empowers pathologists and researchers to improve precision and efficiency, all within a unified, cloud-native platform. This continuous expansion of the AISight IMS and the full menu of AI applications available on the platform from PathAI as well as third-party vendors underscores PathAI’s commitment to providing comprehensive, reliable tools that enhance the field of pathology and ultimately, patient outcomes. “We are committed to advancing precision pathology with cutting-edge AI technology, empowering pathologists with the tools to make more accurate, consistent, and efficient assessments,” said Andrew Beck, CEO of PathAI. “The AIM-IHC Breast Panel is the latest step in our mission to enhance AI-powered scoring for key breast cancer biomarkers.” In addition, the AIM-IHC Breast Panel goes beyond HER2 by offering fast and accurate Ki-67 scoring, addressing the challenges of this emerging biomarker, which has traditionally been time-consuming and labor-intensive. Pathologists no longer need to spend significant time manually counting cells or rely on imprecise approximations. The panel’s automated features, such as classifying invasive cancer and generating percentage-based results for positive cancer cells, provide pathologists with the clarity needed to produce more accurate scoring. The introduction of the AIM-IHC Breast Panel marks a significant step in PathAI’s ongoing mission to enable precision pathology and empower pathologists with the latest AI-driven technologies. This release highlights PathAI’s commitment to improving workflow efficiency, speed, and assessment accuracy. As the AISight® Image Management System continues to expand with new solutions, pathologists gain access to a comprehensive suite of tools that streamline their workflow, accelerating decision-making and reducing time spent on manual tasks. With each of our new advancements, pathologists are better equipped to deliver precise, actionable insights for cancer diagnostic research. Footnotes AIM-IHC Breast Panel, AIM-HER2, AIM-ER, AIM-PR, and AIM-Ki-67 are for research use only. Not for use in diagnostic procedures. AISight is for Research Use Only in the US; AISight Dx is CE-IVD marked in Europe, UK and Switzerland. About PathAI PathAI is a global leader in AI-powered digital pathology solutions, dedicated to improving operational efficiency in pathology labs worldwide. Through its innovative technology and strategic partnerships, PathAI is shaping the future of medical diagnostics and advancing patient care across the globe. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

December 09, 2024 10:00 AM Eastern Standard Time

Supreme Court Of New York Awards RedHill Biopharma Approx. $8 Million Plus Costs In Breach Of Contract Lawsuit

Benzinga

By Meg Flippin, Benzinga RedHill Biopharma Ltd. (NASDAQ: RDHL), a specialty biopharmaceutical company, won a significant legal and financial victory, announcing a summary judgment in its favor and an award of about $8 million plus costs in its New York Supreme Court case against Kukbo Co. Ltd. o f South Korea. RedHill Biopharma sued Kukbo over a breach of contract related to opaganib, the company’s first-in-class orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications. Opaganib has several U.S. government and academic collaborations in place for development for radiation and chemical exposure indications such as Acute Radiation Syndrome (ARS), a phase 2/3 program for hospitalized COVID-19, and a phase 2 program in oncology. Breach Of Contract At The Heart Of Lawsuit The lawsuit stemmed from Kukbo’s failure to make agreed payments to RedHill pursuant to a subscription agreement signed on Oct. 25, 2021, and a subsequent exclusive license agreement inked on March 14, 2022. The two were working to develop opaganib for COVID. The Supreme Court of the State of New York ruled in favor of RedHill Biopharma and, in a summary judgment, ordered Kukbo to pay $8 million, consisting of $6.5 million plus interest amounting to approximately $1.5 million, plus costs. The court dismissed Kukbo’s counterclaims. Kukbo has a right to seek an appeal of the judgment, which may or may not be granted. RedHill intends to pursue its attorneys' fees and collection of the judgment. "RedHill thanks the Court for this crystal-clear judgment, affirming the company's just position from the beginning of the relationship and in making correct provision for full reparation for the contractual breaches,” said Dror Ben-Asher, RedHill’s CEO. Once collected, the summary judgment will give RedHill more cash to develop its pipeline and eliminates a potential overhang on the stock. TipRanks called the ruling a “significant financial victory,” one that highlights RedHill’s adherence to contractual agreements. TipRanks said the end to litigation could boost investor confidence in the company. The positive ruling comes as RedHill Biopharma is making progress in developing opaganib for infectious diseases such as Ebola. Recently, RedHill announced that the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), had selected opaganib for development to treat exposure to Ebola virus disease (EBOV). Under the cost-sharing agreement with BARDA, BARDA will provide partial funding for RedHill to further advance opaganib to mitigate infections and contain EBOV outbreaks. In an in vivo EBOV study with the United States Army Medical Research Institute of Infectious Diseases, RedHill Biopharma said opaganib delivered a statistically significant increase in patient survival time when given at 150 mg/kg twice a day. RedHill Biopharma said it’s the first host-directed molecule to show activity in EBOV. Several other U.S. government countermeasures and pandemic preparedness programs have also selected opaganib for evaluation for multiple indications, reports the company. With litigation in the rearview mirror and RedHill Biopharma making progress in developing opaganib, interested investors may want to pay attention to what’s next from this specialty biopharmaceutical company. Featured photo by Scott Graham on Unsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

December 09, 2024 08:00 AM Eastern Standard Time

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Driving Innovation In Diabetes Management: Glucotrack Begins Enrollment For Human Clinical Trials For Its Implantable Continuous Blood Glucose Monitor

Benzinga

By Joshua Enomoto, Benzinga In the rapidly evolving medical technology sector, diabetes management specialist Glucotrack Inc. (NASDAQ: GCTK) aims to disrupt the present care framework for the benefit of patients. Thanks to its Continuous Blood Glucose Monitor (CBGM), millions of people affected by the disease may be able to access reliable, non-intrusive glucose monitoring. Fundamentally, what distinguishes Glucotrack from its rivals is the combination of real-time accuracy without the delay associated with conventional continuous glucose monitoring systems. In addition, the medical tech specialist offers an implantable format, eliminating the hassles associated with external wearables. Even better, the system’s long sensor life facilitates convenience. To further validate the feasibility of Glucotrack’s product under real-world conditions – and help bring the CBGM system closer to regulatory approval and commercialization – the company has recently announced the commencement of patient enrollment for its short-term human clinical study. Clinical Study Shines Spotlight On Glucotrack’s CBGM Technology Scheduled to be conducted at the Heart Institute (InCor) of the Clinical Hospital of the University of São Paulo – one of the most renowned cardiology hospitals in Brazil and across Latin America – the feasibility study will focus on the capabilities of Glucotrack’s CBGM. A long-term implantable device, the CBGM features no on-body external component. Furthermore, the system is designed to provide three years of continuous, accurate blood glucose monitoring. However, the core attribute of the device is that it measures glucose levels directly from the blood as opposed to interstitial fluid, as is common among competing systems. Blood glucose measurement is the gold standard for glucose measurement. Thus, these capabilities could enable more convenient and less intrusive diabetes management. Principal Investigator Dr. Alexandre Abizaid, MD, PhD will spearhead the study. As the director of Interventional Cardiology at the Heart Institute in São Paulo, Brazil and a visiting professor of medicine at Columbia University Medical Center in New York City, Dr. Abizaid represents one of the leading experts in interventional cardiology. So, why is a diabetes study being performed by an interventional cardiologist? The CBGM is similar in size and form to implantable devices in the cardiovascular space. Thus, the placement procedure is recognizable and widely performed by interventional cardiologists as an outpatient procedure, under local anesthesia in a cardiac catheterization, or cath, lab. The placement procedure takes approximately 20 minutes and only requires a small, half inch incision. Not to mention, diabetes can, and often does, lead to heart disease; people with diabetes are two to four times more likely than others to develop cardiovascular disease. So, cardiologists are becoming more and more involved in patient care for people with diabetes. Notably, the five-day study will include patients suffering from both type 1 and type 2 diabetes. First, clinical researchers will apply the CBGM sensor intravascularly (inside the blood vessel) in the study participants. Second, Glucotrack says the participants will be monitored based on the following protocol: Observation: During this period, researchers will leverage the CBGM technology to monitor blood glucose levels in real time. This observation will provide data on how blood glucose levels fluctuate under various conditions. Glucose challenges: Participants will be given fixed meal challenges, during which their blood glucose levels will be monitored to assess how their glucose responds to different types of food. Comparative analysis: In addition to data collection, the study will focus on the accuracy and performance of the CBGM in measuring blood glucose levels compared to conventional glucose monitoring mechanisms. Advancing Positive Disruption In Diabetes Management With the announcement of the clinical study – with results expected to be available within six to eight weeks – Glucotrack has moved one step closer to positively disrupting the current paradigm in diabetes management. According to Grand View Research, the global diabetes devices market size is large, reaching a valuation of $30.31 billion last year. “Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM,” said Paul V. Goode, PhD, president and CEO of Glucotrack. “We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes.” Forging a path toward significantly reducing the friction and pain points of diabetes care epitomizes the essence of Glucotrack’s device. What separates the enterprise from the competition is the integration of glucose monitoring accuracy, speed and convenience — elements that are often found in disparate corporate silos, the company argues. For instance, Abbott Laboratories (NYSE: ABT) and Dexcom (NASDAQ: DXCM) both have a strong presence in the continuous glucose monitoring (CGM) market, but their systems require frequent sensor changes, usually every 10 to 15 days, depending on the system. Reports show that some of these adhesive patch systems also suffer from wearability challenges. In sharp contrast, Glucotrack says it addresses the shortcomings of conventional CGM devices while elevating the standard of care. Adding to the long list of advantages, the company’s CBGM system also requires minimal calibration. Revolutionizing Diabetes Care With Cutting-Edge Glucose Monitoring Glucotrack is striving to push boundaries in diabetes care with its approach to continuous blood glucose monitoring. With the launch of its clinical study and a focus on delivering real-time accuracy and convenience through its implantable device, the company hopes to address critical gaps in the current market. As Glucotrack advances toward regulatory approval, its technology holds the potential to redefine how diabetes is managed, hopefully offering patients a more seamless and less burdensome solution. Featured photo by Deon Collison on Unsplash This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

December 05, 2024 10:00 AM Eastern Standard Time

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Classiq and AQT Partner to Deliver Seamless Ion-Trap Integration to Tackle Real-World Challenges

Classiq Technologies

Classiq Technologie s, a leader in quantum computing software, and Alpine Quantum Technologies (AQT), a global pioneer in ion-trap quantum computing, today announced a strategic partnership to deliver seamless integration between Classiq’s enterprise-grade quantum algorithm design platform and AQT’s state-of-the-art ion-trap quantum computers. By combining the Classiq platform’s ability to develop sophisticated, scalable quantum circuit implementations with AQT’s award-winning ion-trap hardware, the partnership offers customers expanded options for their quantum computing activities. It enables both enterprises and researchers to tackle complex computational challenges with greater efficiency. Through this partnership, users gain access to a unified workflow that bridges Classiq’s innovative, hardware-aware software tools with AQT’s advanced quantum hardware. Classiq’s platform automates the design, optimization and implementation of quantum algorithms, enabling users to develop, debug and execute sophisticated quantum applications. The integration with AQT’s precision ion-trap systems ensures high-performance operation, catering to the needs of enterprise teams and academic researchers alike. A Shared Vision for Quantum Innovation “We’re dedicated to offering our users the broadest set of quantum computing hardware options,” said Nir Minerbi, co-founder and CEO of Classiq. “The integration of our quantum algorithm design platform with AQT’s advanced ion-trap systems provides a compelling opportunity for enterprises and researchers to implement and run their quantum circuits with ease, scalability and reliability.” “This partnership brings together the best of quantum software and ion-trap hardware, allowing innovation to thrive,” said Dr. Thomas Monz, CEO of AQT. “By integrating with Classiq, we are making it simpler than ever for enterprises and researchers to harness the potential of ion-trap quantum computing for real-world challenges.” Building a Quantum Future This collaboration advances quantum readiness by fostering interoperability within the quantum ecosystem. By uniting their expertise in software and hardware, Classiq and AQT are paving the way for further innovation, benchmarking and the exploration of new quantum implementations. The partnership also opens doors for future collaboration opportunities, such as integrations with high-performance computing (HPC) environments. 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 or YouTube, and visit the Slack community and www.classiq.io to learn more. About AQT Alpine Quantum Technologies (AQT) is a global leader in ion-trap quantum computing, offering high-fidelity systems designed for real-world scalability and applications. Based in Innsbruck, Austria, AQT builds on decades of academic excellence to provide industry-leading solutions for enterprise quantum computing. Follow AQT on LinkedIn and X. For more information about AQT, please visit: www.aqt.eu. Contact Details Rainier Communications Michelle Allard McMahon on behalf of Classiq classiqPR@rainierco.com AQT Franz Domig, Marketing & Communication Director +43 720 262627126 franz.domig@aqt.eu Company Website http://www.classiq.io/

December 05, 2024 08:00 AM Eastern Standard Time

Mainz Biomed Inks Major Deal To Develop A Next-Generation Cancer Test

Benzinga

By Johnny Rice, Benzinga Mainz Biomed NV (NASDAQ: MYNZ) announced a major new collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO) to jointly develop a next-generation colorectal cancer screening product. The partnership will combine Thermo Fisher's advanced technologies with Mainz Biomed's proprietary mRNA-based screening tests, which focus on early detection of colorectal cancer and precancerous lesions. Mainz CEO Guido Baechler highlighted the collaboration's potential to accelerate the development of a home collection screening tool with effective cancer detection. The collaboration will utilize Mainz Biomed's laboratories in Mainz, Germany, to leverage both companies' capabilities in developing advanced cancer screening technologies. Learn more here: This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

November 22, 2024 09:30 AM Eastern Standard Time

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Turning Back The Clock On Aging: Telomir Pharmaceuticals Confirms Telomir-1 Reverses Age And Increased Longevity In Breakthrough Pre-Clinical Study

Benzinga

By Meg Flippin, Benzinga Turning back the clock on aging is the holy grail for the longevity industry, but is something that has proven elusive. That may be changing, thanks to companies like Telomir Pharmaceuticals Inc. (NASDAQ: TELO). The pre-clinical-stage company positioning itself as an emerging leader in age-reversal science is making inroads with Telomir-1, a compound designed to effectively turn back the biological clock and support longevity. Results from a preclinical trial confirmed the efficacy of the compound, reports Telomir. Using advanced in vivo microfluidic technology, in collaboration with Nagi Biosciences SA, the study demonstrated what Telomir said is significant age-reversal effects in aging model organisms treated with Telomir-1. These effects include an extended healthy lifespan, improved mobility and a measurable reversal of age-related decline. “The results we’re seeing with Telomir-1 mark an important step forward in our journey to potentially reverse aging in humans,” said Erez Aminov, Chairman and CEO of Telomir Pharmaceuticals in a press release announcing the trial results. “This study confirms that Telomir-1 can reverse biological aging, extending life while preserving health. We are very excited about the potential applications of Telomir-1 as we progress toward human clinical trials” Anti-Aging In A Compound Telomir-1 is focused on telomere regeneration which involves repairing telomeres or the DNA structures that protect the ends of our chromosomes, similar to caps on shoelaces. Numerous studies have shown fixing them can extend a person’s biological age and even turn back the clock on certain diseases. Telomir Pharmaceuticals says Telomir-1 is a novel small molecule to lengthen the DNA’s protective telomere caps in order to potentially reverse age-related conditions. The novel molecule, which Telomir is testing with mice and dogs with an eye toward human clinical trials, binds to critical metals that wear down telomeres. By limiting the availability of metals and interrupting the enzyme function, Telomir-1 seeks to restore cellular metal homeostasis and reverse a person's or animal’s biological age. The non-toxic oral therapy provides what the company says is a safe and effective alternative to existing treatments with minimal side effects. Telomir says Telomir-1 has the potential to impact patient care by offering new hope for managing and reversing age-related diseases and improving the quality of life for aging individuals. The Study Details The preclinical study, conducted in collaboration with Nagi Bioscience, utilized a sophisticated in vivo microfluidic-based assay to assess the effects of Telomir-1 on the nematode Caenorhabditis elegans, a well-established model for aging studies, reports Telomir. The microfluidic platform allowed precise, automated tracking of lifespan, healthspan and age-related mobility decline in real-time, enabling the research team to accurately measure the effects of Telomir-1 on these critical metrics. Two forms of Telomir-1 were administered in two concentrations. The study found that Telomir-1 significantly enhanced lifespan and healthspan parameters in aged microorganism populations. Some of the key findings include enhanced mobility in older organisms, reduced biological aging and increased lifespan. Subjects treated with Telomir-1 showed improved mobility, particularly in later stages of life compared to untreated controls. Telomir also said the study demonstrated “a measurable” reversal of biological age markers which the company said makes it a promising candidate for longevity treatments. What’s more, the company said Telomir-1 was associated with a statistically significant increase in lifespan among treated populations, further supporting Telomir-1’s role in promoting longevity. "At Nagi Bioscience, we are thrilled to contribute to this groundbreaking study through our innovative microfluidic technology, which allows precise and automated monitoring of aging and healthspan metrics in real-time,” said Dr. Laurent Mouchiroud, Chief Scientific Officer at Nagi Bioscience. “These results highlight Telomir-1’s remarkable potential to improve longevity and health, showcasing the power of cutting-edge tools in advancing age-reversal science." Expanding Telomir-1’s Reach Telomir sees many market opportunities for Telomir-1. There’s the longevity and anti-senescence therapy market, which is valued at $27.11 billion and is projected to reach $44.92 billion by 2031, growing at a CAGR of 6.8%. Then there’s Alzheimer's. Nearly seven million Americans suffer from this disease that attacks memory and cognitive functions. By 2050 that’s forecast to reach close to 13 million. And let's not forget cancer, another area Telomir-1 could prove effective in fighting. The global oncology market size is projected to reach $521.60 billion by 2033, growing at a CAGR of 8.9% from now until then. An additional area where Telomir-1 may help is in the treatment of progeria, a rare genetic disorder that causes accelerated aging in children. Telomir is intensifying its focus on the potential use of Telomir-1 to treat progeria and has engaged with the Progeria Foundation to investigate the effects of Telomir-1 on human progeria cell lines. This study will directly assess Telomir-1’s ability to counteract accelerated aging at the cellular level, offering critical insights into its therapeutic potential for progeria patients. Telomir also planned an in vivo study utilizing a progeria Caenorhabditis elegans model. This advanced microfluidic-based assay will evaluate Telomir-1’s impact on longevity, healthspan and biological aging in an organismal context. Telomir said these two studies represent a comprehensive approach to understanding Telomir-1’s effects on progeria, targeting both cellular and whole-organism models of the disease. On the canine front, Telomir is in talks with the North Carolina State College of Veterinary Medicine to establish a large-scale study on elderly dogs with osteoarthritis, further exploring Telomir-1’s potential to improve joint health and mobility. Turning back the clock on aging is the quest of many companies. Telomir believes it's getting closer to the successful formula. With the company all in with Telomir-1, stay tuned for more news on the trial front from this early-stage anti-aging innovator. Featured photo by JD Mason 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

November 22, 2024 09:00 AM Eastern Standard Time

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BioRestorative Ends Q3 In ‘Strong’ Financial Position, Reports Positive Data For Its Phase 2 BRTX-100 Chronic Back Pain Trial

Benzinga

By Meg Flippin, Benzinga BioRestorative Therapies, Inc. (NASDAQ: BRTX), a regenerative medicine company focused on stem cell-based therapies and products, is advancing toward profitability, narrowing its loss in the third quarter and releasing favorable data for its BRTX-100 treatment for chronic back pain. The third quarter was a busy period for BioRestorative, as it secured a new patent, released what it says is encouraging trial data and continued licensing discussions with a commercial-stage regenerative medicine company – while also reducing its losses. For the three months ending Sept. 30, 2024, BioRestorative posted an operating loss of $2.3 million, marking a 26% year-over-year improvement from $3.1 million in the same period last year. The net loss for the third quarter was $1.1 million, or $0.13 per share. BioRestorative said it ended the quarter in a “very strong financial position” with $13 million in cash and short-term investments. The company had no debt as of the end of the third quarter. “We have continued to execute well across all areas of our business and are looking forward to continuing to update investors on our progress as we close out the remainder of 2024,” says Lance Alstodt, BioRestorative’s chief executive officer. “From an operating perspective, we are thrilled with our third quarter results, as we are seeing initial progress on our path to sustainable profitability, driven by cost containment activities coupled with increased resources dedicated to our commercial programs.” Commercial Programs Making Inroads BioRestorative’s commercial programs got a boost late in the quarter when it announced it obtained a provisional license from the New York State Department of Health (NYSDOH) to process, isolate, expand and preserve allogeneic (non-autologous) donor tissue, including stem cells, for medical research. Previously BioRestorative was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only. “It will significantly enhance our ability to develop an unrivaled clinical pipeline of off-the-shelf cell-based biologic products,” says Alstodt. Meanwhile, the company’s product, ThermoStem®, which uses adipose-derived (brown fat) stem cells to generate new brown fat tissue to target obesity and metabolic disorders, drew attention during the quarter. BioRestorative shared details of the ThermoStem platform at IFATS 2024, the annual industry conference focused on adipose therapeutics and science. BioRestorative believes cell-based therapy candidates generated from its ThermoStem program may allow for lower dosing than GLP-1 obesity drugs or provide an alternative biologic-based treatment. Studies have shown brown fat activation in addition to weight loss, can lead to positive effects on several organs, including the heart, liver and muscle. The company competes with giants like Novo Nordisk (NYSE: NVO), Eli Lilly (NYSE: LLY) and Pfizer (NYSE: PFE) in the space. During the quarter, the Israel Patent Office issued the company a Notice of Allowance for a new patent application covering several fundamental aspects of ThermoStem. It's the 14th international patent. In addition to all that, BioRestorative continued talks for a ThermoStem licensing deal with an undisclosed commercial-stage regenerative medicine company. BRTX-100 Data Encouraging In conjunction with third-quarter earnings, BioRestorative released clinical data for BRTX-100, its autologous stem cell product for chronic lower back pain. It uses a patient’s stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. It’s targeted at the more than 25 million people in the U.S. who suffer from chronic lower back pain each year. Safety and efficacy endpoints from an ongoing phase 2 trial for the treatment of chronic lumbar disc disease (cLDD) were encouraging, BioRestorative reported. The company said no serious adverse events (SAEs) were reported in any of the 10 first patients of the prospective, randomized, double-blinded and controlled study. BioRestorative said there was also no dose limiting toxicity at 26-52 weeks. “Blinded preliminary clinical data of safety and efficacy endpoints from the ongoing phase 2 clinical trial of BRTX-100 in the treatment of cLDD are very encouraging, with patient-reported pain and function outcomes demonstrating a positive trend,” said Alstodt. “Most importantly, at 26 weeks, 70% of the patients are reporting a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy endpoints for the phase 2 trial.” A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or a placebo. The new blinded preliminary safety and efficacy data from the ongoing phase 2 clinical trial of BRTX-100 was described in a podium presentation at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium. From posting encouraging data to narrowing its losses, BioRestorative seems to be making strides on its path to profitability. With more news to come, this may be a story worth paying attention to. To learn more about BioRestorative’s stem cell therapies, click here. Featured photo by National Cancer Institute 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

November 21, 2024 08:45 AM Eastern Standard Time

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News Release

Consumers Primed to Spend on Cannabis, New Poll Finds

NuggMD

A majority of frequent cannabis consumers say their spending on cannabis has gone up during the past year, and a plurality say they expect it to continue to rise over the next year, according to a new consumer poll released today by NuggMD. The poll shows 61% of respondents report spending “more” or “much more” on cannabis over the past year. Forty-five percent said they expect their spending on cannabis products to continue to rise over the next year, while just 25% signaled an intention to reduce their spending. The poll was first reported by Marijuana Moment. “While our poll is a far cry from cash on hand for cannabis retailers and cultivators, it shows that demand is strong and is likely to become stronger in the near term,” said Andrew Graham, head of communications at NuggMD. “This data says that the demand side of the market is durable and highly resilient. Cannabis might be among the most recession-proof consumer products, because most cannabis use is rooted in wellness, not indulgence.” Methodology The two polls were conducted from Oct. 10 to Oct. 13 and Oct. 17 to Oct. 20 and have a margin of error of 5.9% and 4.8%, respectively. NuggMD regularly conducts polls and market research on cannabis using a sample of nearly 1.2m frequent cannabis consumers who live in state-legal markets. The company’s polling capabilities are derived from first-party data it has collected and used since launching in 2015. About NuggMD NuggMD is the nation’s leading medical marijuana technology platform, serving patients in Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, Washington, and West Virginia. They’ve connected over 2,000,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the potential benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit https://www.nuggmd.com. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

November 19, 2024 03:09 PM Eastern Standard Time

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