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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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NAVEX Announces 2024 Excellence Awards Finalists

NAVEX Global

NAVEX, a leading provider of integrated risk and compliance management software, announces today the 2024 NAVEX Excellence Awards finalists. Now in its fourth year, the awards celebrate organizations that demonstrate exceptional commitment to corporate governance, risk mitigation, and ethical practices. Each year, the NAVEX Excellence Awards highlight how robust governance, risk and compliance (GRC) programs can strengthen corporate culture and meaningfully impact business outcomes that matter. The 2024 finalists exemplify how effective GRC initiatives can proactively manage and mitigate risks when woven into the organizational fabric. "Congratulations to this year’s nominees and finalists for their outstanding achievements," said NAVEX Chief Customer Officer, Steve Chapman. "We are proud to partner with customers who are dedicated to advancing their GRC efforts. These awards shine a spotlight on some of the most innovative and effective programs in the industry, and we applaud the compliance teams at these companies for their ongoing efforts to build highly ethical, risk-aware organizations." The winners will be honored in several categories, including Ethics & Compliance, Risk Management, and Risk and Compliance Program of the Year. Selected from a highly competitive pool of nominations, this year’s finalists include: As in previous years, the judging panel brings together a mix of NAVEX leaders and seasoned GRC professionals. This year’s esteemed panel features: Barbara Boehler, Senior Director, Program on Corporate Compliance and Ethics, Fordham Law Bill Cameron, Founder and Principal, Cameron Advisory Services Carol Williams, CEO and Enterprise Risk Management Consultant, Strategic Decision Solutions Carrie Penman, Chief Risk and Compliance Officer, NAVEX Kyle Brasseur, Former Editor in Chief, Compliance Week Kyle Martin, Vice President of GRC Solutions, NAVEX Matt Kelly, Editor and CEO, Radical Compliance LLC Stephen Chapman, Chief Customer Officer, NAVEX Vera Cherepanova, Ethics Advocate, Consultant, Author, Studio Etica Award recipients will be announced after to the 2024 NAVEX Next Virtual Conference on October 1. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Navex Global +1 617-388-5773 scott.levesque@navex.com Company Website https://navex.com

September 03, 2024 08:06 AM Eastern Daylight Time

Aligning Investment Strategies through the Health Care Select Sector SPDR Fund (XLV)

Select Sector SPDR

In the evolving landscape of healthcare, the Health Care Select Sector SPDR Fund (XLV) stands as an investment vehicle for those looking to diversify their portfolio within the U.S. healthcare sector. By tracking healthcare stocks within the S&P 500 Index, XLV offers broad exposure to foundational companies that are central to healthcare in America. Featuring a blend of leading entities across various sub-sectors, XLV's holdings provide investors with exposure to many of the healthcare sector’s diverse industries. Highlighting XLV's Key Holdings* The fund's composition showcases a selection of companies pivotal to healthcare’s wide-ranging facets: Eli Lilly (LLY) - 11.66% UnitedHealth (UNH) - 9.63% Johnson & Johnson (JNJ) - 6.90% AbbVie (ABBV) - 5.94% Merck (MRK) - 5.20% Thermo Fisher Scientific (TMO) - 4.25% Abbott Labs (ABT) - 3.35% Danaher (DHR) - 3.32% Amgen (AMGN) - 3.24% Pfizer (PFE) - 3.14% These holdings span pharmaceuticals, health insurance, medical devices, and diagnostics, illustrating the fund's encompassing approach to the healthcare sector. Sector Dynamics Influencing Healthcare Engagement The healthcare sector is characterized by factors such as demographic trends, technological advancements, and shifts in healthcare delivery models. These elements contribute to the sector's role within the broader economy and its relevance to consumer needs. Healthcare spending's share of Gross Domestic Product (GDP) has maintained a significant position, reflecting the sector's integral role in the economic landscape. This dynamic underscores the steady relevance of healthcare in consumer and governmental expenditure. The Strategic Appeal of the XLV Fund Investing in the Health Care Select Sector SPDR Fund (XLV) allows individuals to engage with the healthcare sector through a vehicle that offers balanced and diversified exposure. The fund's structure is designed to mitigate the risks associated with investing in individual companies by providing a portfolio that reflects the sector's breadth. For investors seeking a methodical approach to incorporating healthcare into their investment portfolios, XLV presents a tactful option. The fund's focus on core healthcare companies, coupled with its diversified strategy, affords a stable pathway to participation in the sector's activities. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. *Holdings, Weightings & Assets as of 7/31/24 subject to change DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007756 EXP 10/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

September 02, 2024 05:00 AM Eastern Daylight Time

Brightberry Adds Lids to their Line of Non-Toxic Bowls for Infants

Rev Up Marketers

Brightberry, a trusted name in children's silicone tableware, is excited to unveil the latest update to its product line: spill-prevention lids to fit their non-toxic bowls designed specifically for infants. This new collection reflects Brightberry's ongoing commitment to providing safe, high-quality products for young children and their families. The newly launched bowls are made from non-toxic silicone and certified Foods, Consumer Goods and Feedstuffs Code (LFGB), the highest standard. LFGB is generally viewed as the European FDA, though they’re far stricter on certifications – LFGB is required for companies operating in France and Germany. These LFGB non-toxic bowls and lids contain no BPA, PVC, lead, phthalates, or any other toxins. Brightberry’s products are crafted from premium, food-grade silicone, free from harmful chemicals such as BPA, phthalates, and PVC. With growing concerns over the safety of children's products, Brightberry has taken a proactive approach to ensure their products exceed safety standards, offering peace of mind to parents everywhere. These bowls feature a unique suction base that securely adheres to most surfaces, significantly reducing the likelihood of spills and accidents during mealtime. The bowls are designed with practicality in mind; they are dishwasher-safe for easy cleaning and microwave-safe for convenient reheating. Available in a range of vibrant colors, the bowls add a fun element to feeding time while supporting developmental milestones such as self-feeding. "We understand the importance of providing products that are both safe and functional," says the team at Brightberry. "Our new line of non-toxic bowls not only meets the highest safety standards but also incorporates thoughtful design elements that make feeding easier and more enjoyable for both parents and children." This product launch represents Brightberry's dedication to innovation and customer satisfaction. The company regularly updates its product lines based on customer feedback and emerging market trends. By combining safety, durability, and aesthetic appeal, Brightberry continues to set the standard for excellence in children's tableware. Brightberry's new line of non-toxic bowls for infants is now available for purchase through their website and at select retail partners. The company invites parents and caregivers to explore this latest offering and experience the difference that quality design and materials can make. For more information, visit Brightberry's Website or contact their customer service team. About Brightberry Brightberry specializes in designing and producing high-quality silicone tableware for babies and toddlers. The company is committed to making mealtime safer and more enjoyable for families, focusing on innovation, safety, and customer satisfaction. Contact Details Brightberry Mateya Lotric contact@brightberry.com.au Company Website https://brightberry.com.au/

August 30, 2024 08:29 AM Eastern Daylight Time

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Syntekabio Introduces Develop Now, Pay Later with AI-powered STB LaunchPad Program

Syntekabio, Inc.

Syntekabio (KOSDAQ: 226330), an artificial intelligence (AI) based drug development company, today announced its innovative new offer designed to minimize risk, save time and costs, and increase the success rate of companies developing novel therapies. The new ‘Develop Now, Pay Later’ offer is Syntekabio’s latest initiative to invest in the success of its clients. This model enables pharmaceutical and biotechnology companies to test the validity of a target protein of interest without incurring any upfront costs. Should a project demonstrate viability, Syntekabio then employs its STB LaunchPad program, powered by its proprietary AI-driven DeepMatcher ® technology platform, to deliver hits and optimized leads as well as IND-enabled candidates. Jongsun Jung, PhD, CEO of Syntekabio, remarked, “We want our clients to achieve their goal of bringing safer and more effective therapies to patients. Thus, our mission at Syntekabio is to deliver to our clients first-in-class or best-in-class compounds, fast. We strongly believe in the capability of our technology and so, to further invest in our clients’ success, we have introduced our Develop Now, Pay Later model to support groundbreaking drug development work and reduce the risk for our clients at the outset.” Syntekabio is dedicated to making drug discovery as optimized and as low risk as possible. Clients can first take advantage of a complimentary feasibility study to determine if their project is viable. The next step is to submit any target protein for analysis via the STB LaunchPad program. There are no upfront fees. The client only pays for the work once the agreed upon validated results are obtained. Syntekabio’s AI accesses over 10 billion known compounds as well as 1,400 in vitro/in vivo compatible drug targets covering over 70% of human diseases. This technology is powered by Syntekabio’s AI Bio-Supercom Center, which houses an immense infrastructure of 5,000 servers, 40,000 CPU cores, and 2,500 GPUs fueling the Company’s algorithms. The Company has a comprehensive suite of advanced proprietary tools designed to accelerate the drug discovery and development process. For more information about Syntekabio, STB LaunchPad and Develop Now, Pay Later, please click here. About Syntekabio Syntekabio Co., Ltd. (KOSDAQ: 226330) is a drug discovery company bringing together biology and AI/ML since 2009 and facilitating the discovery of first-in-class and best-in-class compounds, rapidly. The Company has its own supercomputer cloud, along with a global contract research organization network to complement and validate its computational results. Syntekabio offers clients a one-stop shop, with technologies and tailored services to rapidly generate and optimize drug candidates from target to IND-enabling. Syntekabio’s disease-agnostic physics-based platform generates a continual stream of hits, leads, and drug candidates that are readily available for purchase. The Company also undertakes client-specific projects to identify highly promising development candidates for specific targets and indications. Visit the Syntekabio website at www.syntekabio.com or follow the Company on LinkedIn for the latest updates. Contact Details MC Services AG - Media inquiries (US) Laurie Doyle +1 339-832-0752 syntekabio@mc-services.eu Company Website http://www.syntekabio.com/

August 29, 2024 10:15 AM Eastern Daylight Time

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Palatin Technologies: Utilizing The Melanocortin System As The Basis For Innovation In Drug Development – Targeting Inflammatory & Autoimmune Conditions, Obesity And Sexual Dysfunctions

Benzinga

By Kyle Anthony, Benzinga Palatin Technologies (AMEX: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, received the first FDA approval for a melanocortin agent, for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, with its product, Vyleesi ® (bremelanotide injection) – and it has big plans for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra ®, cialis ® ) monotherapy The melanocortin system is a group of hormones, receptors and other molecules in the body that regulate various physiological processes, including skin pigmentation, appetite, energy balance and inflammation. For Palatin Technologies, the melanocortin system has been a source of innovation. The firm leverages its knowledge of the melanocortin system to design therapeutics that directly engage one of the body’s natural pathways to resolve harmful inflammation, providing a novel approach that allows affected tissue time to heal. The Mission Of Palatin Technologies Founded in 1986 by Dr. Carl Spana and other scientists with the initial aim of developing proprietary technologies and drug candidates for large markets with unmet needs, including cardiovascular disease and cancer, the firm has undergone a series of changes over the years. In the early 2000s, Palatin began focusing on the melanocortin system, particularly developing drugs that target melanocortin receptors. The company’s mission is to leverage its unique insight and expertise in the industry and the melanocortin system to develop groundbreaking therapeutics for inflammatory and autoimmune diseases, focusing on ocular conditions, plus obesity and sexual dysfunctions. Maximizing The Capabilities Of The Melanocortin System The melanocortin system is mediated by a family of five related receptors that are essential to the body’s control of inflammation, immune response, metabolism, steroid hormone production and sexual function. As mentioned previously, Palatin Technologies’ current focus is on the design and development of receptor-selective melanocortin agonists for inflammation and autoimmune conditions, with an emphasis on ocular diseases, plus obesity and sexual dysfunctions. Palatin Technologies’ therapeutics work by activating endogenous melanocortin pathways to resolve damaging inflammation and allow affected tissues time to heal. Research has shown melanocortin agonists can prevent and reverse intestinal and ocular inflammation in animal models. Current ocular drugs can be limited by drawbacks such as inadequate efficacy, high discontinuation rates and delayed onset of action. These challenges result in a less-than-ideal treatment experience, causing frustration and driving the need for more effective solutions. Melanocortin receptors, which are found on the surface of various cells in the eye and within immune cells in ocular tissue, represent a promising target for melanocortin agonists to offer relief and healing for individuals suffering from ocular diseases. For inflammation and autoimmune diseases, current treatments – including steroids, immune modulators and biologics – largely work by broadly suppressing the immune response. However, these methods can weaken the body's overall immune function, leading to unwanted side effects and raising safety concerns. Melanocortin agonists offer the potential to resolve inflammation without these adverse effects and safety issues associated with immunosuppressants. Palatin Technologies: Success And Product Pipeline Though Vyleesi was Palatin Technologies' first commercial product, the company recently announced several program advancements: Patient dosing has started for the clinical study entitled: BMT-801: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity Topline Results Expected Q1 Calendar Year 2025 FDA Confirms Acceptability of Palatin’s Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED) MELODY-2 & MELODY-3 Phase 3 Clinical Trials Targeted To Start Later This Calendar Year Topline Results Expected Q4 Calendar Year 2025 Treating Eye Related Diseases As referenced previously, Palatin is exploring using melanocortin agonists for age-related eye diseases. As detailed in the company’s corporate presentation, diseases such as dry eye disease, glaucoma and retinopathies are sizable target markets. Dry eye disease (DED) or keratoconjunctivitis is a multifactorial disorder of the tears and ocular surface. Symptoms include dryness, irritation, redness, discharge and blurred vision. Inflammation plays a prominent role in the development and amplification of the signs and symptoms of DED. According to research compiled by the company, the global market size for DED is estimated to be worth $7.0 billion in 2024, growing to $12.3 billion by 2032. Earlier this year, Palatin announced the phase 3 clinical results for its PL9643 melanocortin agonist treatment of DED. Regarding the findings, Carl Spana, Ph.D., President and CEO of Palatin, stated, “We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign and symptom endpoints.” PL9643 represents an opportunity to bring relief to dry eye disease sufferers. According to Palatin, while DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment with an excellent safety and tolerability profile. There is a sizable market opportunity for the other previously mentioned eye diseases: Palatin’s research states that the 2030 global market estimate for glaucoma is $11.52 billion, and the 2027 global market estimate for retinopathies is $27 billion. Palatin has ongoing melanocortin receptor programs for each disease to explore treatment methods. Treating Autoimmune Diseases There is also a growing opportunity to treat the underlying inflammation in autoimmune diseases that physicians commonly treat with broad immunosuppressants that potentially increase the risk of complications. Palatin Technologies, with an ongoing phase 2 clinical trial, is exploring how its treatments can tackle ulcerative colitis (UC), which the company says could benefit nearly 1 million people in the U.S. who suffer from an autoimmune disease that manifests as chronic inflammation of the colon. Palatin’s research states that the global ulcerative colitis market was estimated to be worth $5.5 billion in 2021 and is projected to be worth $8 billion by 2026. Palatin’s oral MCR1 agonist (PL8177) was developed to resolve inflammation directly in the colon, avoiding broad immunosuppression and adverse effects with its potent, selective compound. Palatin reports that two phase 1 studies have produced promising results – the first demonstrated the significant safety and tolerability of PL8177, while the second highlighted the value of an oral, delayed-release polymer formulation that can achieve local release without systemic absorption. PL8177 has advanced and is now being investigated in a phase 2 clinical trial. Treating Obesity Obesity represents a rising worldwide public health concern. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, coronary heart disease, stroke and certain cancers. Obesity is associated with increased healthcare resource use and high economic burden. Safe and effective obesity treatments therefore remain a critical unmet need. In the United States, about 42% of adults live with obesity, and one out of five teens between the ages of 12-19 live with obesity, according to data compiled by Palatin. “The growth of GLP-1 agonists to treat obesity has been incredible and highly effective in the short run, but data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year, said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “This often results in a rebound effect with patients gaining back significant weight. Our research coupled with emerging clinical data indicates that combining an MCR4 agonist with incretin therapeutics like tirzepatide may result in synergistic effects on weight loss allowing for increased weight loss at lower and better-tolerated doses.” Sexual Dysfunction Product Expansion And Product Development Milestones The success of Vyleesi, which was sold to Cosette Pharmaceuticals in December 2023 for $12 million upfront and up to $159 million in sales milestones, has established a precedent for success in the sexual dysfunction category for Palatin Technologies. Presently, the firm is looking to build on this success and is exploring a product for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra ®, cialis ® ) monotherapy. According to Palatin, over 30 million men in the U.S. suffer from ED, with approximately 35% of them being inadequately served by existing treatment options. Palatin believes that their MCR4 agonists can be a safe and effective treatment therapy for ED. Across Palatin’s product roadmap, several milestones are slated to occur in the latter half of 2024 or the first half of 2025. Regarding the second half of calendar year 2024, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 will initiate enrollment (patient dosing has commenced), Melody-2 and Melody-3 phase 3 clinical trials for the treatment of DED will begin, and the phase 2 proof-of-concept interim data for PL8177 for ulcerative colitis is expected to readout. Regarding the first half of calendar year 2025, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 topline results are expected, and the pharmacokinetics study for the clinical program with bremelanotide co-formulated with a PDE5i for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy will start. A Vision For The Future For Millions Of Patients Overall, Palatin Technologies is actively expanding its clinical programs and progressing toward potential new therapies for patients with limited or ineffective treatment options. Melanocortin pathway therapies represent a promising and versatile approach to treating various conditions, with ongoing research and development expanding their potential applications. Palatin Technologies is at the forefront of this treatment approach, potentially helping reshape the medical landscape. For more information about Palatin Technologies, visit its website. Featured photo by Louis Reed 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

August 29, 2024 08:45 AM Eastern Daylight Time

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Monogram Orthopedics (NASDAQ: MGRM) Readies Commercialization Of Next-Gen Surgical Robot

Benzinga

By Gerelyn Terzo, Benzinga When most people think about robotics, they might envision movies like the popular science fiction film RoboCop. While the entertainment industry put robotics on the big screen, companies like Austin, Texas-based Monogram Orthopedics (NASDAQ: MGRM) are making robotics a reality in everyday life. Monogram is an AI-powered robotics company dedicated to improving human health, including an early specialization in orthopedic surgery. This summer, it has been inching closer to its vision for the commercialization of its surgical robot. According to Virtue Market Research, the orthopedic surgery robotic market was worth $6.8 billion as of 2022 and is predicted to be valued at $16 billion by 2030, reflecting a CAGR of 13%. Monogram could be strategically positioned to capitalize on this growth with its mBôs surgical robot, which it is readying for commercialization, mVision technology and underlying IP. Benzinga recently had the opportunity to sit down with two Monogram surgeons – Dr. Bobby Jamieson and Dr. Fabio Orozco – to discuss the company’s next-generation orthopedic implants harnessing a combination of 3D printing, robotics and pre-operative imaging. Monogram’s 3D Printing Tech Dr. Fabio Orozco, an orthopedic surgeon, runs a medical practice that specializes in hip and knee replacements, with all of his surgeries involving robotics. After completing his training at Thomas Jefferson University in Philadelphia, Pennsylvania, he started a practice in the Northeast that is exclusive to robotics. He told Benzinga he performs 1,000 hip and knee replacements each year. With a very high success rate, hip and knee replacements are a testament to the strong track record of orthopedic surgeons. However, Orozco looks forward to using Monogram’s surgical robots on a daily basis, for, he says, greater precision, better patient care and improved outcomes. “You start thinking about 0.5 millimeters and 0.5 degrees and being able to reproduce your plan exactly to reality in a patient. And then you start seeing rapid recoveries - patients don’t need six months to recover from surgery or don’t need physical therapy. That’s when you see the excitement. We are better when we use technology, and when we use Monogram technology, we continue to be better and better,” said Orozco. Dr. Orozco performs 100% of his surgeries using robotics technology, including approximately 1,000 knee and hip replacements each year. He has been using Monogram’s Mako robot for the past decade, noting that it’s his go-to solution for every hip and knee replacement surgery. Dr. Orozco believes that when Monogram’s next-gen mBôs technologies become a reality, they will take orthopedic surgeries to a different level. “When you bring Monogram to your table, it’s going to make a significant difference in the way that we practice orthopedics,” he said. Chief among the new features that surgeons are anticipating from Monogram is the 3D printing of implants, which replicates the structure of human organs and tissues and can be customized to a patient’s body. Additionally, Monogram says its technology introduces increased precision and ease of use that will simplify robotic surgery significantly. For his part, Dr. Bobby Jamieson has been involved in robotics for years, having studied under the tutelage of orthopedic robotics pioneer and IBM (NYSE: IBM) alum Bill Barger and recently relocated his practice from Northern California to Southern Utah. Jamieson specializes in hip and knee surgeries, completing some 650 of them each year. Upon FDA approval of Monogram’s surgical robot, Jamieson looks forward to introducing the company’s technology to his patients. “I’ve been able to watch Monogram go from zero to where it is today and this is definitely something I’m interested in bringing into the practice once we get the approval on it,” Jamieson said. He also agreed that Monogram is taking orthopedic surgery to the next level. He said that what he appreciates most about the company’s technology is that it takes the best of all robotic platforms available, including features such as navigation, and builds them into a single robot, setting the tech suite apart and drumming up excitement in the industry. Monogram’s Competitive Edge With a market cap of over $90 million, Monogram’s advantage begins with its seasoned team and their strong robotics knowledge. The company’s singular focus on surgical robotic systems can give it a competitive edge against larger corporations that have a broader focus. “Monogram Orthopedics has the advantage is – they eat, drink and sleep robotics, which is awesome,” Jamieson said. “Then you add in 3D printing, and it just allows them to be a little bit further advanced than other surgical robots that are on the market right now.” He compares the precision of Monogram’s surgical robot to that of a driver in a golf game, saying that the tech helps surgeons hit the right spot every time with the ultimate patient-specific knee or hip replacement. That is what Monogram’s robot will deliver, and on top of that, there’s excitement around implants and being able to create the ultimate patient-specific knee or hip replacement for patients, where Monogram is also leading the charge. As Monogram transitions from gen-one to gen-two with its technology. Jamieson likens it to the iPhone, saying that most people wouldn’t even know how to access the first-generation iPhone model today because it’s just so obsolete. “I think that a lot of the robotics are those gen ones. The advantage that Monogram has coming to market is that it’s already at this iPhone five or 10 [level]… they’re able to come in as the newest technology that’s on the market and put it into one robotics system.” In the most recent update, Monogram Orthopedics submitted its 510(k) for its mBôs TKA System to the U.S. Food and Drug Administration (FDA) and has since received administrative approval to proceed with the next step, which involves a formal review. FDA approval is key for orthopedic surgeons to take Monogram’s surgical robots further, including the advancement of the technology on the clinical side. After that, they can begin using it in practice. “It’s an exciting time. It’s also obviously one of the most difficult steps, making sure all the “t’s” are crossed and all the “i’s” are dotted and, for that matter, making sure it’s safe for patients. And so it’s really important and also just exciting,” said Jamieson. Investors who are interested in the future of surgical robotics can learn more about the investment opportunities that Monogram Orthopedics has to offer here. Featured photo by PublicDomainPictures 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

August 29, 2024 08:30 AM Eastern Daylight Time

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Nuvectis Pharma Rises in Pre-Market Following FDA Orphan Drug Designation for NXP800, Fueling Optimism Ahead of Key Clinical Data

Global Markets News

Nuvectis Pharma (NASDAQ: NVCT) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation for its lead candidate, NXP800. This designation, specifically for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers, marks a critical step forward in Nuvectis’s mission to address unmet needs in oncology. Orphan Drug Designation: A Strategic Advantage The FDA’s Orphan Drug Designation is awarded to drugs that show promise in treating rare diseases affecting fewer than 200,000 people in the U.S. For Nuvectis, this designation not only validates the potential of NXP800 but also provides several strategic benefits. These include tax credits for clinical trial costs, exemption from certain FDA fees, and potentially seven years of market exclusivity upon approval. NXP800 targets ARID1a-deficient cancers, a subset of ovarian cancers that present significant treatment challenges. The Orphan Drug Designation underscores the importance of this candidate in potentially offering a new, more effective treatment option for patients with this specific genetic mutation. Background and Market Impact This latest achievement builds on Nuvectis Pharma’s earlier successes. Earlier this year, the FDA granted Fast Track Designation to NXP800 for its development in platinum-resistant, ARID1a-mutated ovarian cancer. The Fast Track status, combined with the Orphan Drug Designation, highlights the urgent need for innovative treatments in this space and positions NXP800 as a potential game-changer in oncology. Financial analysts have taken note of Nuvectis’s progress. H.C. Wainwright recently reiterated its buy rating for Nuvectis, setting a price target of $21. This optimistic outlook reflects the market’s confidence in the company’s strategic direction, particularly as it prepares to release key clinical data later this year. Anticipation for Upcoming Results The next few months are expected to be pivotal for Nuvectis Pharma. The company is poised to share updates from its ongoing Phase 1b clinical trial of NXP800, which targets patients with platinum-resistant, ARID1a-mutated ovarian cancer. This trial is being closely watched, as positive results could significantly advance the development of NXP800, bringing it closer to pivotal trials and eventual regulatory approval. Additionally, Nuvectis is also conducting a Phase 1a dose escalation study for NXP900, its second key candidate, which targets YES1/SRC-driven tumors. Updates from this study are expected to provide further insights into the safety and potential efficacy of NXP900. ### Nuvvectis' Full announcment, titled " Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers" was published on August 29th, 2024. ### This article 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/fcm9n/pdf. Global Markets News Network is a commercial digital brand compensated to provide coverage of innovative companies and industries and it is thus subject to conflicts of interest. Contact Details Global Markets News News Coverage ronald@futuremarketsresearch.com

August 29, 2024 08:20 AM Eastern Daylight Time