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Telomir Pharmaceuticals (NASDAQ: TELO) Featured In Local ABC Exclusive Showing Positive Outcomes Of Proposed Age Reversal Pill In Dogs

Benzinga

By Meg Flippin, Benzinga Turning back the clock on aging is a never-ending quest with people, large companies and startups pouring blood, sweat, tears – and tons of money – into finding a solution. One company that seems to be getting closer to its goal is Telomir Pharmaceuticals Inc. (NASDAQ: TELO), a pre-clinical pharma company seeking to lead developments in longevity science through treating age-related conditions. Its leading drug compound, Telomir-1, was featured in an ABC television news segment highlighting promising "age reversal" outcomes in a study with two senior dogs. Lengthening DNA’s Protective Caps Telomir-1, the company's leading drug compound, is designed to regenerate telomeres – the protective DNA structures at the ends of our chromosomes, often compared to the caps on shoelaces. Research has demonstrated that repairing these telomeres may extend biological age and reverse certain age-related conditions. By targeting telomere regeneration, Telomir-1 aims to slow down the aging process and combat diseases linked to telomere shortening. Telomir Pharmaceuticals says Telomir-1 is the first novel small molecule to lengthen the DNA’s protective telomere caps 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 oral therapy potentially provides what the company says is a safe and effective alternative to existing treatments with minimal side effects. Telomir-1 Gets Props In News Segment In the segment, "ABC7 Exclusive: New study reveals promising results for age reversal pill on dogs," the potential of Telomir-1 was on display through the stories of Zeus and Benson, two senior dogs from Donte's Den rescue organization in Myakka City, Florida. After being treated with Telomir-1, both dogs exhibited improvements in their health conditions, according to Telomir. Zeus, a 12-year-old German Shepherd, showed complete remission of terminal cancer, while Benson, a 12-year-old Newfoundland suffering from severe arthritis, regained his mobility, leading to what caretakers described as a miraculous recovery, reports Telomir. "The results of this study highlight the groundbreaking potential of Telomir-1. Our priority is to advance the rigorous scientific research required to bring this promising treatment to humans and pets through the regulatory process as swiftly and safely as possible," said Erez Aminov, CEO of Telomir. "At Telomir, we are dedicated to transforming the future of longevity science, and these early findings bring us one step closer to making that vision a reality." Aminov was named CEO earlier this month after the passing of Chairman of the Board and Chief Executive Officer Christopher Chapman, Jr., M.D. Aminov was most recently CEO of MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA). The positive preclinical trials have shown that Telomir-1 may have several applications in the veterinary market, which is large given that Americans are poised to spend $156 billion on their pets by the end of this year. The use of Telomir-1 in the two dogs was observed by Telomir's special advisor Dr. Michael Roizen, the former Chief Wellness Officer of the Cleveland Clinic and a leader in age-related medicine. In this small compassionate use program, remarkable improvements in the health and vitality of the dogs after treatment with Telomir-1 were noted, offering a glimpse into the potential future applications for humans, reported Telomir. "The preliminary results we're seeing with Telomir-1 are very encouraging. By lengthening telomeres, we believe Telomir-1 can promote cell regeneration and potentially reverse several aspects of aging or age-related conditions. I'm excited to continue working with Telomir to explore the full potential of this innovative therapy,” Roizen said. More Tests Underway Nobody wants to get old and that includes pets. With Americans pouring tons of money into keeping their pooches happy and healthy, they may someday have another tool: Telmoir-1. With encouraging results out of its study with two dogs and more positive results expected down the road, this may be a company worth paying attention to as the quest to reverse time continues. Featured photo by Simone Dalmeri 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 05, 2024 08:40 AM Eastern Daylight Time

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Mainz Biomed (NASDAQ: MYNZ) And Liquid Biosciences Team Up To Fight Pancreatic Cancer With Early Detection Tool

Benzinga

By Meg Flippin, Benzinga Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, has inked a collaboration deal with Liquid Biosciences, an AI-focused bio-analytics company, to potentially add pancreatic cancer detection to its colorectal cancer screening test ColoAlert®. Liquid Biosciences leverages its EMERGE AI analysis technology platform to help biopharma companies, diagnostics industries and academic institutions identify effective drugs and therapies. Mainz Biomed is developing PancAlert, a screening test that combines genetic and potentially microbiome biomarkers to detect pancreatic cancer. Research has shown that the microbiome – the mix of bacteria in the gut – plays a big role in how tumors develop and progress. The constitution of the microbiome can potentially hurt the immune system’s ability to recognize and attack cancer and render drugs less effective. By combining DNA and microbiome biomarkers, Mainz is betting early detection of pancreatic cancer is possible. Promising Early Results In the initial phase of the collaboration, the companies evaluated biomarkers from Mainz’s research program, co-funded by the German government, by applying a single algorithm developed by Liquid Biosciences using its EMERGE platform. Mainz said the results of the feasibility analysis were promising, giving both companies confidence that PancAlert could be added to ColoAlert in the future. ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis, offering what the company says is a better early detection than fecal occult blood tests. In the second phase of the collaboration, Mainz and Liquid Biosciences will expand the biomarker evaluation to include microbiome biomarkers Mainz evaluated in 2023 and an expansion of the algorithm. The companies are targeting to complete this analysis in the fourth quarter of 2024. “We are excited by the opportunity to collaborate with Liquid Biosciences on PancAlert, which is being developed for early-stage disease detection with the goal of being a first-in-class screening test for this deadly form of cancer,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “Liquid Biosciences is already a key partner in our Next Generation colorectal cancer screening test. Expanding our partnership will allow us to bring the power of AI to this critical problem.” Pancreatic Cancer Is Deadly And Growing Pancreatic cancer is a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. It is now the third-leading cause of cancer deaths, and by 2030 it is expected to grow to second place, surpassing colorectal cancer deaths. This year alone, about 66,440 Americans will be diagnosed with pancreatic cancer, a record for this deadly form of cancer. What’s more, about 51,750 Americans are expected to die from the disease this year. Among cancers, pancreatic disease is a tough one to treat. It’s a highly aggressive form of cancer that attacks the pancreas, an organ needed for digestion. With limited treatment options, the five-year survival rate is just 13%. It doesn’t help that most people are diagnosed with pancreatic cancer in a late stage when it has already spread to other parts of the body. That’s particularly true with pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer that’s created from the cells that line the ducts of the pancreas. It's one of the most lethal forms of pancreatic cancer. Given the difficulty in treating pancreatic cancer and the increasing incidents, a lot of medical research is directed toward earlier detection and better treatments. As a result, the global pancreatic cancer market is projected to reach $7.4 billion by 2032, growing at a CAGR of 13.7% over 2023-2032. Mainz’s collaboration with Liquid Biosciences is the latest in the company’s collaborations to bring its next-generation diagnostics technology to the masses. By combining biomarkers, Mainz is seeking to demonstrate a better and more effective way to spot deadly cancers that currently go undetected and untreated until it's too late. 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

September 05, 2024 08:35 AM Eastern Daylight Time

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What If Your Most Profitable Strategy Also Made the World a Better Place?

Fordham Gabelli

As the world grapples with complex challenges such as climate change, poverty, and human rights issues, organizations are uniquely positioned to drive positive change. A new study titled “Social Profit Orientation: Lessons from Organizations Committed to Building a Better World,” recently published in the Journal of Marketing, explores how companies can simultaneously generate profit and foster societal well-being. The research, conducted by a team of esteemed academics, including Leonard L. Berry (Texas A&M), Tracey S. Danaher (Monash University), Timothy Keiningham (St. John's University), Lerzan Aksoy (Fordham University), and Tor W. Andreassen (Norwegian School of Economics), examines the benefits of adopting a social profit orientation to benefit both the organization and society. This approach encourages organizations to invest resources purposefully to enhance the common good. The study, based on 62 in-depth executive interviews across 21 organizations worldwide, reveals the significant benefits of embracing a social profit orientation. These organizations develop new approaches and strategies that address critical problems, thereby driving business innovation and improving societal outcomes. What is Social Profit Orientation? Social Profit Orientation is an organization-wide perspective where organizations embrace in their core mission the creation of sustainable, positive social and environmental impacts on individuals, communities, and society at large. Organizations with this orientation proactively invest resources such as knowledge, infrastructure, labor, reputation, money, and time to enhance the common good, especially improving the well-being of people and safeguarding the health of the planet. It reflects a deliberate, conscious effort to address systemic social or environmental challenges, rather than being merely a by-product of making financial profits. Examples from the Study Oportun tackles financial exclusion by providing affordable credit to underserved communities, offering an alternative to payday lenders. With significant investments in technology, Oportun has successfully issued millions of loans, enabling its customers to avoid exorbitant interest rates and fees. CEO Raul Vazquez highlights their challenge: “50% of customers who come to us have no FICO [credit] score, and other folks we serve may have a score based on limited history.” Despite these obstacles, Oportun has managed to provide more than $18.2 billion in credit by year-end 2023, saving its customers $2.4 billion in interest and fees. Gundersen Health System (renamed Emplify Health) exemplifies how a holistic approach to sustainability can be woven into the fabric of an organization. Under the leadership of Dr. Jeff Thompson, Gundersen became the first U.S. health system to offset 100% of its fossil-fuel use with self-produced energy. Their initiatives include harnessing solar and wind power and transforming landfill biogas into electricity and heat. Dr. Thompson remarks, “We are not just a ‘fix-it’ shop. Our mindset was: how do we protect the environment so it is a part of how we work, how we live, and how we work with our communities.” By adopting a social profit orientation, organizations not only drive meaningful societal impact but also experience enhanced legitimacy, stronger stakeholder relationships, improved employee engagement, and increased innovation. These benefits contribute to long-term business success and sustainability. Best Practices for Building a Social Profit Orientation Align employee and organizational values to create a unified mission. Ensure organizational resources and governance structures maximize societal benefits. Inspire executive and board leadership to deeply commit to social profit goals. Make informed investment decisions that focus on initiatives with the greatest social impact. Measure and evaluate social impact rigorously to ensure meaningful contributions. Foster external partnerships and communicate purpose through compelling storytelling. “Organizations today are at a crossroads where they can choose to be mere profit-generating entities or become catalysts for global change. Our study shows that the most profitable strategy might also be the one that makes the world a better place. By embracing a social profit orientation, organizations can lead their sectors, drive innovation, and make significant societal impacts,” said Lerzan Aksoy, Dean at Fordham University’s Gabelli School of Business. To attain a full copy of the research and download the associated teaching guides click here. To interview any of the authors of the paper, please reach out to the press contacts above. About Fordham University’s Gabelli School of Business Founded in 1920, the mission of Fordham University’s Gabelli School of Business is to inspire and empower positive global change, developing students into compassionate business leaders and supporting faculty members and students in the ongoing generation of new knowledge. The Gabelli School has become a driver of social innovation by equipping graduates to be business leaders who understand and meet the need for sustainability in business and who are able to harness the power of social responsibility for both financial success and societal impact. Through its many graduate and undergraduate degree programs and a diverse range of faculty research initiatives, the Gabelli School of Business works collectively to redesign business as a sustainable force for prosperity. Contact Details Fordham Gabelli School of Business Paola Curcio-Kleinman +1 212-636-6311 pcurciokleinman@fordham.edu Marino Taryn Schofield +1 973-919-4377 fordhamgabelli@marinopr.com Company Website https://www.fordham.edu/gabelli-school-of-business/

September 04, 2024 09:00 AM Eastern Daylight Time

September 04, 2024 09:00 AM, Eastern

Benzinga

By Johnny Rice, Benzinga Dr. Ann Childress and Shane Schaffer, Chairman & CEO of Cingulate (NASDAQ: CING), were recently guests on Benzinga’s All Access. Cingulate is a biotechnology company developing drugs for a range of underserved conditions. The company has developed a proprietary technology called Precision Timed Release™ (PTR™). The technology allows a single pill to contain multiple doses of a drug, relieving the pill burden many people with chronic conditions suffer. Cingulate says it will be submitting a New Drug Application within a year. Watch the full interview here: Featured photo by Thought Catalog 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 04, 2024 09:00 AM Eastern Daylight Time

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Helping Redefine Medicine: AJNA BioSciences’ Path For FDA-Approved Plant Medicines

Benzinga

By Anthony Termini, Benzinga AJNA Biosciences is currently raising funds to bring its natural solutions to market! Click here for details. Back in the 1960s, a British pharmacologist discovered that aspirin had an effect on blood platelets that could reduce the risk of heart attacks and strokes. Unfortunately for patients, aspirin manufacturers couldn’t say that because of labeling requirements of the U.S. Food and Drug Administration (FDA). While the FDA is a vital part of providing patients and consumers with safe products, there are also more archaic aspects of the administration. Despite the reality that botanical solutions have been around and trusted for thousands of years, botanical or natural drugs have long been excluded from FDA-approval. It was only in 2016 that the Center for Drug Evaluation and Research developed guidelines for new drug applications for botanicals. It described the process pharmaceutical and biotechnology companies should follow to get a botanical drug approved by the FDA. AJNA’s Mission To Bring Natural Options To Market AJNA BioSciences is among the biotech companies seeking FDA approval for its botanical product. The company is working to develop the world’s first FDA-approved full-spectrum cannabinoid drug and a robust pipeline of other plant medicines. However, the path to launching a new FDA-approved drug can be long. According to management consultants McKinsey & Company, it takes about 12 years to bring a drug to market. To optimize the process, McKinsey suggests that drug makers need to be nimble and agile. AJNA BioSciences CEO Joel Stanley points out that “the botanical category is so new that only four FDA-approved botanical drugs exist to date.” Ajna hopes to break the mold and eventually introduce many FDA-approved botanical drugs to the market. “AJNA BioSciences is the first biotech company to be working with botanicals under a DEA Schedule-1 license,” says Joel Stanley, the company’s CEO. This is a significant milestone for the company because FDA approval is a critical component of bringing new drugs to market. Federal law requires that a manufacturer show that the drugs they produce are safe and effective. Additionally, FDA approval helps inform the Centers for Medicare & Medicaid Services, which is a critical step to getting a drug included on insurance reimbursement schedules. The company firmly believes in providing patients with a variety of options that are not only safe but affordable and available through insurance. Another one of AJNA’s goals is to make botanical drugs an accepted component of a physician’s and patient’s routine treatment options. Demand for botanical solutions has been increasing for years, and AJNA’s strategy is to follow the same blueprint as large pharmaceutical companies that bring new drugs to market. Herbal medicine products are not considered a distinct regulatory category in the U.S., unlike Europe or Canada. Instead, a botanical drug is defined by its intended use in the treatment cycle of disease – like all other medicinal drugs. However, until recently, strict regulatory policy blocked the development of prescription drugs made from plants – this has now changed. Obtaining FDA approval helps lead to greater physician advocacy. In other words, doctors have more tools at their disposal to help treat patients and are able to impact positive structural change to evolve treatment options. AJNA is committed to producing natural botanical drugs that have undergone rigorous laboratory and clinical scrutiny to demonstrate that they deliver “nature, backed by science.” Stanley says that this is part of why AJNA is “the first company to receive a plant variety protection patent for cannabis.” The company also understands that FDA approval will make more patients feel comfortable with trying a more unconventional approach to treatment; for patients who have only been exposed to synthetic drugs, botanical drugs may seem unfamiliar, but FDA approval minimizes those hesitations. How Investors Might Evaluate AJNA’s Business AJNA’s mission is to bring natural options to the pharmaceutical industry, and it is bringing a number of proprietary strengths to the proposition. The company reports that it enjoys a wide economic moat that serves as a barrier to potential competitors. Having already raised over $250,000 from a venture capital firm, the company is currently hosting a raise to help further its vision. AJNA has established rigorous research and development processes with a strong team behind it. Its research facilities are registered with the FDA, with scientists from Harvard Medical, Johns Hopkins and NYU. Stanley is also an experienced CEO who has taken a similar company public. Chief Medical Advisor Orrin Devinsky helped obtain the first FDA approval for a cannabis-derived drug. Furthermore, AJNA’s research team has successfully shepherded more than 500 drug applications through the FDA process. While the company is not looking to replace big pharma, it wants to offer patients more solutions. As Stanley points out, “By investing in AJNA, you’re helping to change the healthcare paradigm to include optionality that none of us have ever had. We come from nature, not a lab.” More information is available on the Wefunder website. Featured photo courtesy of AJNA BioSciences. 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 04, 2024 08:45 AM Eastern Daylight Time

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PathAI Collaborates with GoldPath to Elevate Digital Pathology Capabilities with AISight Image Management System

PathAI

PathAI, a global leader in digital pathology, announced today that GoldPath, an independent pathology service provider based in Duarte, California, has adopted the AISight Ⓡ1 Image Management System (IMS). In a competitive and evolving pathology landscape, where the demand for accurate and timely diagnostics is ever-increasing, the integration of digital pathology is becoming a critical differentiator for independent laboratories. GoldPath selected AISight after an extensive evaluation of various image management systems, recognizing it as the optimal solution to streamline workflows, enhance case management, and support a broad range of use cases. Through adopting AISight, GoldPath aims to reduce turnaround times for referring physicians and deliver cutting-edge pathology services. "As we continue to see a growing need for high-quality pathology services, integrating digital pathology is essential to maintaining our competitive edge and ensuring the best patient outcomes. AISight stood out for its robust capabilities, offering the versatility we need to manage our caseload effectively and improve efficiencies throughout our processes," said Gerardo De La O, CEO and Co-Founder of GoldPath. "The selection of PathAI's AISight Image Management System by a forward-thinking independent laboratory like GoldPath highlights the significant impact our technology can have on pathology operations. Their adoption of AISight demonstrates how our solution can enhance laboratory efficiency in the rapidly evolving field of digital pathology," said Andy Beck, MD, PhD, co-founder and CEO of PathAI. "We are excited to support GoldPath as they set new standards for pathology services." AISight, a cloud-native enterprise workflow solution, is central to PathAI's mission of revolutionizing the digital pathology ecosystem. Trusted by pathologists worldwide, AISight offers a comprehensive platform for case management, workload balancing, and image management, providing GoldPath with tools to address a wide array of histopathology use cases with exceptional versatility and efficiency. About PathAI PathAI is a leading provider of integrated AI and digital pathology solutions dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. For more information, please visit www.pathai.com. About GoldPath GoldPath is an independent, fully accredited pathology laboratory in “the City of Health” Duarte, California, dedicated to providing exceptional patient care, cutting-edge technology, and outstanding customer service. With a highly trained team of medical professionals and client relations specialists, GoldPath offers fast, accurate, and personalized laboratory services and a full range of ancillary support and practice management solutions. Footnote 1:AISight is for research use only. Not for use in diagnostic procedures. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

September 03, 2024 10:00 AM Eastern Daylight Time

Early Cancer Detection Saves Lives - This Biotech Has A Promising New Test

Benzinga

By Johnny Rice, Benzinga Bill Caragol, CFO of Mainz BioMed (NASDAQ: MYNZ), was recently a guest on Benzinga’s All-Access. Mainz BioMed, maker of clinical laboratory tests, says it is committed to saving lives and reducing healthcare costs through early disease detection and prevention. For cancer and chronic conditions, patients can now live longer, healthier lives thanks to advances in diagnostic technology. Genetic and genomic tests are at the forefront of this progress. By revealing patients' unique genetic profiles, these tests can allow doctors to tailor treatments more effectively, ushering in an era of personalized medicine. Caragol spoke about promising data from recent trials. Watch the full interview 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 03, 2024 09:00 AM Eastern Daylight Time

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Mainz Biomed Seeks FDA Approval For Colorectal Cancer Test It Says Is Nearly Twice As Sensitive As Others – A Look At Pipeline And Milestones

Benzinga

By Anthony Termini, Benzinga In August 2020, popular actor Chadwick Boseman succumbed to colorectal cancer at the age of 43 after a four-year battle with colon cancer. The untimely death of the Black Panther star saw many fans overcome with grief but also brought attention to the danger posed by such cancers. Colorectal cancer is the second leading cause of cancer death in the United States, with more than 100,000 cases diagnosed so far in 2024. Mainz Biomed (NASDAQ: MYNZ), a German company whose U.S. offices are in Berkeley, California, believes the threat can be mitigated by technology and is working on a predictive test that may be more effective than solutions currently on the market. Benzinga recently sat down with the company’s CFO, Bill Caragol, to discuss the challenge and all the work the company is doing to help address it. The Available Options For Detecting Colorectal Cancer The standard of care for detecting colorectal cancer has since 1969 been the colonoscopy. The procedure is invasive and not very pleasant. In 2014, the fecal immunochemical test (FIT) received FDA approval. The test analyzes a person’s DNA to detect advanced adenomas, the pre-cancerous polyps that “may be the most valid…marker for present and future colorectal cancer risk,” according to research published by the National Library of Medicine. Blood-based tests are also available to detect colorectal cancer risk. However, some in the medical community are cautious about their use. According to David Lieberman, MD, chair of the American Gastroenterological Association’s Colorectal Cancer Workshop, “blood tests are neither as effective or cost-effective" as established colorectal cancer screening tests – something that Mainz’s Caragol testifies to, as well, stating that doctors continue to prescribe stool-based tests over blood tests because of the clinical differentiation since stool-based tests are better at detecting early-stage cancer, despite the “yucky factor.” He added,”Remember, [with] colorectal cancer – you detect late-stage, there’s a roughly 10% survival. When you catch it in early-stage, there’s 90% survival.” Mainz’s Breakthrough Device Leads To Next-Generation Screening Test Mainz has developed a molecular diagnostic solution to detect colon cancer risk. In July, Mainz submitted an application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for a non-invasive colorectal cancer product that includes a portfolio of mRNA biomarkers. Studies conducted by Mainz revealed that its mRNA-powered test showed a sensitivity for detecting precancerous polyps that is double that of products currently on the market. In those studies, competitors’ tests “demonstrated efficacy of detecting advanced adenomas in the 40% range,” says Bill Caragol. Caragol added that readouts from the three clinical studies Mainz conducted between 2023 and 2024, “demonstrated consistent accuracy above 80%, a quantum leap...over the other stool-based tests.” Mainz says its flagship product, ColoAlert®, misses far fewer cases than its competitors’ tests. Mainz puts the number at up to 60% fewer cases. Its next-generation FIT test is an enhancement of ColoAlert and was submitted to the FDA in July for Breakthrough Device designation. The next-generation FIT test is complemented by a proprietary algorithm that uses artificial intelligence and machine learning to identify mRNA biomarkers in order to better detect the early warning signals of potential colorectal cancer. Mainz said the test is “a new gold standard for noninvasive detection of advanced adenomas.” The company is scheduled to conduct an FDA pre-market approval study in 2025 for its next-generation test. A focus of the study is to distribute the next-generation test kit through the currently existing network of FDA-approved national reference testing laboratories in the United States. This differs from other products currently on the market in that the companies that make those test kits also control the testing process. As Caragol describes it, “every test [is] manufactured by them, sent out by them, returned to them [for analysis], test results delivered.” As a result, says Caragol, Mainz will have “the only product that will fit into the largest distribution.” Milestones Mainz Is Focused On For The Year Ahead Mainz has a clear strategy for approaching the market. Caragol said that they realize that as a small company targeting a large market, they will have to strategically align themselves with larger companies. The company is looking to partner with a PCR provider as well as one of the national reference labs. PCR labs specialize in blood, urine and other molecular testing to detect pathogens, commonly used for diagnosing infections like COVID-19. National reference labs offer a wide range of high-accuracy diagnostic services, including PCR, serving as centralized hubs for specialized testing across various locations. Having these partnerships in place is necessary for Mainz to conduct its FDA pre-market approval study. Importantly, they will also be important allies if the company receives approval to sell the kits. They will be integral components of Mainz’s commercial go-to-market strategy. At that point, Mainz’s commercial roadmap will focus on creating partnerships and awareness within physician networks and health care professionals about the differentiating benefits of the ColoAlert mRNA powered test. Investment Drivers For Companies Like Mainz Biomed If the company can meet each of its milestones, then it could set a course for future growth. The U.S. market for colorectal screening “is over $30 billion a year,” according to Caragol. He notes that the market is double that worldwide. There are a number of companies competing domestically for colorectal screening, the most notable of which is Exact Sciences Corp. (NASDAQ: EXAS). Caragol says Exact has about a 10% share of U.S. sales. As such, there may be an opportunity for Mainz if its next-generation test receives FDA approval in the next few years. The company says that a successful launch could open the door to other products, including test kits for pancreatic and other gastrointestinal cancers – significantly expanding its addressable market. For more information about Mainz Biomed listen to the conversation Bill Caragol had with Benzinga’s Zunaid Suleman. Featured photo by Furiosa-L from 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 03, 2024 08:35 AM Eastern Daylight Time

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AJNA BioSciences’ Strategy For Market Leadership In Botanical Drug Development With Magic Mushrooms And Cannabis

Benzinga

By Anthony Termini, Benzinga Individual investors can own equity in AJNA BioSciences on the same terms as venture capitalists and professional angels. Click here for details. Consumers are increasingly demanding natural health solutions, with recent surveys demonstrating that a majority of consumers believe products with natural ingredients are healthier and that botanical supplements are effective. Many people believe that “food should be medicine.” Littleton, Colorado-based AJNA Biosciences says it is aiming to build a bridge “between what people want, and physician advocacy they can trust.” AJNA's Pharmaceuticals Come From Nature Backed By Science AJNA is focused on developing a new class of drugs derived from botanicals. The company is exploring plant and fungi species with therapeutic compounds that address specific conditions. “The future of medicine is actually millions of years old,” says Joel Stanley, CEO of AJNA. This ethos is guiding AJNA’s development of two drug candidates focused on treating conditions that it estimates today affect more than 80 million people. The company’s research team, led by scientists from Harvard, Johns Hopkins and New York University, are working on botanical drugs to treat or support people with Autism Spectrum Disorder and Generalized Anxiety Disorder. Today, there is no FDA-approved natural remedy for either of these conditions, reports AJNA. They can both be treated with synthetic compounds engineered by big pharmaceutical companies, but those drugs can come with a number of unpleasant side effects. AJNA distinguishes itself by participating in the evolving field of botanical drug development and is pioneering a new regulatory pathway to produce drugs from plant medicine that are ultimately approved by the U.S. Food and Drug Administration (FDA). AJNA has advanced the development of two prescription drug candidates by standardizing botanical raw materials to meet strict FDA guidelines. The first drug candidate, CBD for Autism Spectrum Disorder (ASD), is preparing to enter phase 2 clinical trials with an upcoming Investigational New Drug (IND) filing, while the second candidate, Psilocybin for Generalized Anxiety Disorder (GAD), is approaching phase 1. The two drugs in development are a full-spectrum cannabis-derived drug and a psilocybin-based antidepressant. AJNA says it will look to expand indications for these products beyond autism and anxiety to also include post-traumatic stress disorder, various sleep disorders, attention-deficit/hyperactivity disorder and chronic pain. A Holistic Approach Based On Ethics And Sustainability AJNA believes it is tapping into rising consumer demand for holistic treatment options that include natural remedies. The company says that demand has never been higher. As part of the company’s ethos, it is committed to sustainable methods in its research and development processes. It is also committed to reducing its ecological footprint. AJNA follows Stanley's previous venture, a company he founded with his brothers called Charlotte’s Web Holdings (OTC: CWBHF). It started out as a mission not a company, giving away an extract to those who could benefit, then gained public recognition after the CBD oil was being used to treat seizures in 5-year-old Charlotte Figi. The company prioritizes minimizing the use of unnecessary and potentially harmful chemicals. AJNA's psilocybin drug is processed using only the water from the fungi itself, without any added agents or artificial chemicals. If this drug gains FDA approval, it could be one of the few organic options available on the market. Additionally, the company's commitment to environmental sustainability results in a largely organic waste stream, which is repurposed as compost and used as a soil amendment throughout the Denver area. AJNA Could Be Poised To Benefit From Significant Shifts In Perception The demand for psychedelic-assisted therapy is increasing at a time when the FDA is defining new drug development pathways for botanical drugs to get approved. This is helping AJNA build a bridge between what people want and the physician advocacy necessary to gain wider public trust. The company’s Chief Medical Advisor, Orrin Devinsky, is one of the first clinicians to research cannabinoids. His work as principal investigator led to the development of Epidiolex, the only FDA-approved cannabis-derived drug currently on the market. “It is important for us to provide a [botanical] option that has clinical science behind it, so doctors can get behind it, so insurance can cover it for people in the future,” said Stanley about AJNA’s research and development and pending clinical trials. AJNA also gains an advantage from unique intellectual property regulations that protect botanical drugs. Plant variety patents provide 20 years of protection, significantly longer than the five to seven years typically granted to synthetic drug compounds. Big Pharma May Look To Botanicals For Future Growth AJNA believes that major pharmaceutical and biotechnology companies will increasingly recognize the therapeutic and commercial potential of botanical drugs. Cannabinoids and psychedelics could be part of future opportunities for large players to acquire or merge with smaller botanical drug companies. This is part of an established playbook in the biotech industry. A small company’s successful drug development platform creates potential liquidity for investors. This may include the acquisition of a single drug candidate or the entire company. In many cases, these acquisitions take place before the target company begins to generate revenue. In AJNA’s case, the company is working with Wefunder to help it raise capital. Wefunder is a public benefit corporation with a goal to “fix capitalism” in addition to helping companies create shareholder value. More information is available on the Wefunder website. Featured photo courtesy of AJNA BioSciences. 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 03, 2024 08:30 AM Eastern Daylight Time

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