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Mainz Biomed (NASDAQ: MYNZ) Announces Positive Topline Results From Cancer Detection Studies, Including 92% Sensitivity Rate

Benzinga

By James Blacker, Benzinga Mainz Biomed NV (NASDAQ: MYNZ), a company that specializes in the early detection of cancer, recently shared encouraging topline results from a clinical study designed to test the next-generation version of its colorectal cancer screening tool, ColoAlert®. The company recently unveiled compelling findings from its most expansive group to date at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, as well as virtually. The comprehensive examination consisted of 690 participants from 30 reputable gastroenterology facilities in Europe and the United States, and introduced previously unexplored and unreported specimens. The results underscored the effectiveness of Mainz Biomed's multimodal screening test, marking significant advancements in colorectal cancer detection. Notable figures include a sensitivity of 92.3% for colorectal cancer, a specificity of 90.1%, a sensitivity rate of 82.2% for advanced precancerous lesions, and an impressive high-grade dysplasia detection rate of 95.8%. With the success of this study, Mainz Biomed now plans to move forward with a major clinical trial in the U.S., which will involve up to 15,000 participants. If this next trial produces positive results, the company says its next-generation tool has the potential to disrupt the at-home colorectal cancer screening market by becoming a new gold standard. “The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” said Guido Baechler, CEO of Mainz Biomed, “These results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.” Why Early Detection Matters According to the American Cancer Society’s latest publication, the incidence of colorectal cancer has increased alarmingly since the mid-1990s, continuing to rise between 1% and 2% each year in people under the age of 55. Since the mid-2000s, the mortality rate among young people has increased at a similar rate. Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer-related deaths worldwide. However, it is also the most preventable, with early detection leading to survival rates above 90 %. About Mainz Biomed Founded in Germany, Mainz Biomed is becoming a leading global provider of easy-to-use diagnostic solutions for patients and healthcare providers everywhere. The company develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. It is involved in the commercializing of its product portfolio in Europe, the United States and the rest of the world, and develops innovative products to quickly and reliably identify the early onset of several leading deadly conditions – such as pancreatic cancer and colorectal cancer. The company reports that its CE-IVD-cleared flagship product, ColoAlert, is the first DNA-based screening test for colorectal cancer in Europe, and that it is developing proprietary genetic testing methods for pancreatic cancer. For 2023, the company earned revenues of $895,479, which compared to revenues of $529,877 in 2022. What Sets ColoAlert Apart In a market with established players such as Cologuard from Exact Sciences Corporation (NASDAQ: EXAS), ColoAlert stands out as an innovative product that addresses the need for a convenient and user-friendly test. Mainz Biomed claims that ColoAlert is not only more effective than traditional blood tests at detecting precancerous polyps early but also detects more cases of colorectal cancer than other stool tests. As Mainz Biomed plans its upcoming major trial in the U.S., the company could be one to watch as a force in the fight against cancer. More information about the company can be found at mainzbiomed.com. Featured photo by Gerd Altmann 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

June 05, 2024 08:30 AM Eastern Daylight Time

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OncoCyte's Innovative Approach: Potential in Precision Diagnostics

RazorPitch OCX

Chronic conditions such as organ transplant rejection and cancer represent significant challenges in modern healthcare, demanding precise diagnostic tools for effective management and treatment. For organ transplant patients, the risk of graft rejection remains a persistent threat, necessitating continuous monitoring to ensure long-term success. Similarly, the complexity of cancer requires advanced diagnostics to tailor treatments to individual patients, optimizing therapeutic efficacy while minimizing adverse effects. Amidst these challenges, OncoCyte Corporation (NASDAQ: OCX ) has emerged as an innovative player in the precision diagnostics market. The company's tests enhance clinical outcomes for patients undergoing organ transplants and cancer treatments. With recent strategic partnerships and regulatory advancements, OncoCyte has spearheaded transformative advancements in the field. OCX’s product portfolio includes VitaGraft, a clinical blood-based test for monitoring solid organ transplants, and GraftAssure, a research-use-only test for the same purpose. Additionally, DetermaIO and DetermaCNI are designed for oncology applications, predicting responses to immunotherapies and monitoring therapeutic efficacy, respectively. Partnerships In April 2024, OCX partnered with Bio-Rad Laboratories (NYSE: BIO) to commercialize the GraftAssure assay. This agreement leverages Bio-Rad's extensive reach and expertise in the life sciences sector, facilitating the co-marketing of GraftAssure in the U.S. and Germany. Bio-Rad holds exclusive global distribution rights outside these regions. This collaboration is pivotal for scaling OncoCyte's operations and meeting the growing demand for transplant diagnostics. The partnership also includes an option for Bio-Rad to acquire IVD commercial rights upon FDA clearance, subject to specific milestones. This option comes with a second equity investment into OncoCyte, reflecting Bio-Rad's confidence in the product's market potential. Riggs noted, "The QX600 ddPCR platform, along with their expertise in the life science market, makes Bio-Rad a natural partner for our transplant technology." Financial Performance OncoCyte's Q1 2024 financial results indicate a strategic focus on commercialization and cost-efficiency. The company reported gross proceeds of $15.8 million from an equity private placement, including a significant investment from Bio-Rad. This funding is crucial for advancing OncoCyte's product pipeline and expanding its market presence. Operational efficiency is evident, with OncoCyte reducing its cash burn to $3.9 million, reflecting a capital-efficient business model. The collaboration with Bio-Rad and the anticipated commercial launch of GraftAssure RUO test kits in Asia, the U.S., and the EU are expected to drive revenue growth and broaden the company's market reach. Riggs remarked, "The collaboration with Bio-Rad is pivotal for the upcoming launch of our GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing accessible point-of-care diagnostics and continuous innovation in transplant rejection monitoring." Publication in New England Journal of Medicine OCX announced a significant milestone on May 30, 2024, with the publication of promising data on VitaGraft Kidney in the New England Journal of Medicine. This phase 2 study highlights VitaGraft Kidney’s potential to revolutionize kidney transplant care by accurately monitoring graft health through measuring donor-derived cell-free DNA (dd-cfDNA). For investors, this development signals substantial market potential. VitaGraft Kidney's ability to monitor therapeutic efficacy and detect disease recurrence opens new revenue streams. This test could become a standard in post-transplant care, driving repeated testing and long-term revenue. VitaGraft Kidney addresses a critical unmet need. Up to 20.2% of kidney transplant patients develop antibody-mediated rejection (AMR) within 10 years, with no FDA-approved drugs currently available for AMR management. The combination of VitaGraft testing and felzartamab therapy offers a promising solution, potentially improving patient outcomes and healthcare efficiency. OCX CEO Josh Riggs emphasized the breakthrough nature of this study, stating, “This positions VitaGraft Kidney as a crucial tool in managing transplant health. Our recent partnership with Bio-Rad expands our capacity to deliver these innovative solutions globally.” Riggs highlighted the test’s competitive edge in detecting AMR up to 10 months earlier than current protocols, enhancing patient care, and strengthening OncoCyte’s market position. The findings will be presented at the 2024 American Transplant Congress on June 3, 2024. This presentation is expected to further validate VitaGraft Kidney’s clinical value and could act as a catalyst for broader market adoption. OncoCyte’s latest publication not only validates VitaGraft Kidney’s clinical potential but also strengthens the company’s market position. As OCX continues to innovate and expand its market reach, investors can anticipate significant growth opportunities in the precision diagnostics sector. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by PCG Advisory Inc. to assist in the production and distribution of this content. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

June 05, 2024 07:00 AM Eastern Daylight Time

Clarified Precision Medicine and xCures Form Strategic Partnership to Transform Patient Outcomes Through Precision Oncology

Clarified Precision Medicine

Clarified Precision Medicine, the only company that provides oncologists with prioritized therapy options via a combination of expert medical provider review and underlying artificial intelligence (AI) computational algorithms, and xCures, a healthcare technology company that delivers real-time clinical data to power precision medicine support, today announced a strategic partnership to dramatically advance the field of precision oncology. The two companies will come together to enhance cancer-care delivery and personalized patient treatment recommendations through precision medicine and data-driven analysis. The goal of the alliance is to better identify and understand current gaps in providing precision medicine and ultimately improve patient outcomes. Oncology faces an immediate need to improve access to precision medicine. In the United States, there are 18 million patients with a history of cancer and 1.9 million new cancer diagnoses each year. Patients who receive precision therapies have survival rates that are three times greater than those who do not. However, 75 percent of doctors say they need help interpreting the genomic tests that make precision medicine possible — which, in turn, leads to more effective utilization of these powerful 21st-century tools. To that end, Clarified and xCures will collaborate on patient-level data analytics and work together to improve provider support, education, and communication. The two organizations will develop learning systems focused on innovative solutions in precision oncology, such as predictive analytics and treatment optimization. Clarified will contribute its specialized treatment recommendation system, which combines insights from experienced medical professionals with support from its AI-driven treatment algorithm. The company’s team of expert medical reviewers will provide clinical oversight. xCures will provide its AI-driven technology platform, which excels at extracting the critical information needed for care among the complex cancer patient data and enhancing access to medical records. “This partnership unites two of the most innovative leaders in the field of precision oncology,” said Clarified Precision Medicine CEO Rajni Natesan, MD, MBA. “Clarified is the leading expert in closing gaps at the last mile of precision oncology, with an AI platform and the greatest understanding of physician needs and individual patient outcomes. xCures is a leader in data and technology that transforms clinical efficiency and patient care. This powerful alliance enables us to overcome obstacles in cancer care that can only be addressed by an advanced, data-driven understanding of oncology at the patient level.” "We are excited to partner with Clarified Precision Medicine to harness the power of real-time clinical data and advanced analytics,” said xCures CEO Mika Newton. “This collaboration will enable us to deliver highly personalized and effective treatment recommendations, ultimately improving patient outcomes in precision oncology. By combining our strengths, we can address the critical need for better access to precision medicine and support oncologists in making data-driven decisions that enhance patient care." In addition to improving the utilization of precision medicine, the alliance will have significant capabilities in data collection and analytics to drive precision oncology research. The technology integration between Clarified and xCures will facilitate retrospective and prospective data analysis to improve treatment strategies and patient care outcomes. About Clarified Precision Medicine Clarified Precision Medicine is the first scalable molecular tumor board with a combination of ML-based platform plus medical group, offering expert clinical somatic and pharmacogenomics consultations through its ClarifiedSelect™ and OncoGuardian™ solutions. Clarified accelerates the delivery of guidelines-based genomic insights to patients and providers by bringing together nationally recognized experts in medical oncology, oncology pharmacy, data integration, and molecular pathology who have over 100 years of collective experience in the application of precision oncology. For more information, visit clarifiedprecisionmedicine.com About xCures Inc. Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health. Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com, or visit www.xcures.com Contact Details For Clarified Precision Medicine info@clarifiedmedicine.com Company Website https://clarifiedprecisionmedicine.com/

June 04, 2024 03:00 PM Eastern Daylight Time

DPH BIOLOGICALS DELIVERS NEXT GENERATION BIOLOGICALS WITH EXPANDED PORTFOLIO BUILT ON NOVEL TECHNOLOGY PLATFORM

DPH Biologicals

DPH Biologicals, a leading developer and supplier of agricultural biologicals, announced its new Prime platform that uses a patented production process for Bacillus spp., a leading plant growth rhizobacterium, to accelerate the germination of bacteria spores, supporting overall plant development while providing crops with more consistent resilience against heat, drought, and alkaline and saline soil conditions. “Historically biologicals have been dinged for inconsistent performance when used in a variety of environmental conditions. By utilizing a unique manufacturing process, we’ve enabled Bacillus spores to germinate faster resulting in more consistent performance especially in stressful conditions. Ultimately, Prime gives channel partners and growers more confidence in biologicals and allows them to differentiate from the plethora of microbial-based products on the market,” said Mick Messman, DPH Bio President and CEO. Kept in a dry, dormant state to germinate quicker, Prime spores colonize the root zone faster, capturing nitrogen while solubilizing potassium and phosphorus for more effective nutrient uptake. In a lab trial, Prime enabled more than 70% of Bacillus spores to germinate at temperatures as high as 98.6 degrees Fahrenheit, while those without Prime germinated less than 10% after 50 minutes. Additionally, nearly all spores with Prime germinated in high salt environments, while those that were not treated with Prime did not germinate. With exclusive rights, DPH Bio is the first to offer Prime-based products and has recently integrated Prime into several existing biofertilizers in its TerraTrove™ product line, including Envelix Prime available this fall and Essential™ Prime PAK available for the 2025 crop season. “We are excited to see results coming through our science-based approach to support our channel partners and growers. Powered by Prime, the next generation of biologicals delivers higher quality sustainable options that consistently work," said Messman. For more information about DPH Bio’s technology platforms – RegenAphex™ and Prime, as well as DPH Bio’s expanded product portfolio, visit www.dphbio.com. About DPH Biologicals DPH Biologicals, LLC attracts, develops and scales technologies improving broad market access and simplifying the grower experience with biologicals. Based on investments in scientific research, field testing, partner relationships and product development, and leadership-owned since 2024, DPH Bio yields success through science and relationships, standing at the leading edge of clarity, trust and proven, profitable solutions for agricultural biologicals. For more information, visit www.dphbio.com Contact Details AgTech PR for DPH Bio Georgie Smith georgie@agtechpr.com Company Website http://www.dphbio.com

June 04, 2024 08:30 AM Eastern Daylight Time

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Novus Reports Q1 Results And Key Success Factors Following DEA Rescheduling

Novus Acquisition & Development Corp

Miami, Florida - ( ThriveNewsWire ) - Novus Acquisition & Development Corp d/b/a Novus Cannabis MedPlan (OTC Markets: ( NDEV ) is a leading national supplemental health insurance carrier and pioneer in offering cannabis in health plans for recreational and medicinal users. It released its update on its Q1 2024 results, Rx Dispensing Platform, and Key Elements that fuel its success after the Drug Enforcement Agency (DEA) announced that cannabis will be rescheduled. Novus Cannabis MedPlan (Novus) has been integrating cannabis into health plans since 2015. With a network of over 1,200 agents, brokers, and dispensaries, Novus aims to make cannabis-based treatments more affordable and accessible through insurance plans, benefitting a wider range of consumers. Here are three key highlights that contribute to Novus' success. 1) Financial Snapshot: The company utilizes a receivable-based business model with minimal overhead and no convertible debt, demonstrating consistent organic growth year over year. No Dilution: No common stock has been issued after June 15, 2021. No Sales of Insider Shares: For close to 3 years Gross Revenue Increase: During this reporting period, Gross Revenue increased by 6.8% compared to March 31, 2024 and 2023, respectively, Net Revenue Increase: During this reporting period, EBITDA increased by 19.47% compared to March 31, 2024, and 2023. Profit Margin: During the reporting period, the company experienced a gradual increase in gross profit margins, with margins of 43.14% in 2023 and 45.2% in 2024 Cash and Cash Equivalents: There was an increase of 1.8% compared to the financial reporting periods on March 31, 2024, and December 31, 2023. This is in contrast to the higher increase of 6.84% in the period from March 31, 2023, to 2024. Debt Transparency: Frank Labrozzi, the CEO, is owed $158,061. He has no plans to exercise the call provision, and this debt instrument has no equity conversion provision. Leak Out Vendor Shares: All vendors who received treasury-issued stock must gradually sell their shares. The selling amount is determined based on 15% of the average daily trading volume over the past 30 days. 2) Introducing the Rx Dispensing Platform Novus is strategically positioning its cannabis health plans to become a prominent player in mainstream healthcare insurance by acquiring an Rx Dispensing Platform tech stack. Frank Labrozzi, CEO of Novus, stated, "This advancement will significantly impact cannabis in health plans. By promoting collaboration between brands and dispensaries, we aim to empower policyholders with more choices, enabling them to purchase the brands they prefer at any dispensary. Cannabis brands can use the platform to connect directly with dispensaries and showcase their products at no cost. This will improve product distribution efficiency, increase brand visibility, provide real-time inventory data, and facilitate product research for the policyholder. An added bonus to For Rec Users: This platform serves recreational users who prefer not to disclose personal information like their policyholder status to access plan benefits. Instead, users can discreetly order services for a small subscription or transaction fee. 3) Key Success Factors Midwest Expansion: Novus has partnered with Heya Wellness, a prominent cannabis company in Missouri, to offer MedPlans to 4.3 million potential policyholders in the Midwest. By leveraging Missouri's favorable reciprocity laws, Novus aims to maximize the benefits for our sales hub based in St. Louis. Health Carrier Alliances Integration with Traditional Healthcare: By treating cannabis as a traditional pharmaceutical product and including it in insurance plans, Novus could help normalize cannabis use for medical, recreational, and non-users. Now that there is federal approval, Novus bridges traditional healthcare and the cannabis industry, enhancing major healthcare carriers who have expressed interest in integrating Novus' cannabis-based prescription plans into their benefits packages, establishing a connection between the two industries. Compassionate Care Act (CCA): The CCAs, which the Supreme Court sanctions, typically focus on making medical marijuana accessible to workplace patients with specific conditions. Human Resources departments are revising workplace policies to allow employees to access medical marijuana through employer-sponsored health plans. Novus plans to cover some costs through tax-deductible health savings and health reimbursement accounts. Opioid Settlement Framework: The opioid settlement framework is a legal agreement aimed at resolving litigation against pharmaceutical companies and health carriers accused of contributing to the opioid crisis. It includes $50 billion for prevention, treatment, and recovery programs with the goal of mitigating the crisis' impact and preventing future misuse. Novus is playing a crucial role in reducing opioid use by offering states and private organizations alternative treatment options through our developed health plans that help patients transition from opioids to medical cannabis. Compliance with the Veteran’s Affairs (VA): Veterans are increasingly interested in utilizing cannabis for treatment—over 88% support medical cannabis programs. Novus has developed health plans following VA guidelines to integrate cannabis benefits for veterans. In closing: As Novus adjusts to the positive changes in federal cannabis regulation, we are prepared to utilize our niche approach to cannabis in health plans, which utilizes a receivables-based business model. This approach strategically enables us to organically invest in critical areas such as marketing, improving engagement with policyholders and providers, and establishing a reliable cash flow management system. This positions Novus as a significant player in the fast-evolving cannabis integrated into health insurance plans. Do your research on our company to understand our potential in shaping the future of healthcare. Visit our Investor Relations page to see for yourself. About Novus Further Research: Financial Filings: Click Here Quote: Click Here Website Click Here Investor's Page Click Here Video Of Investment Highlights: Click Here Novus Acquisition & Development Corp. (NDEV) operates through its subsidiary, WCIG Insurance Services, Inc., offering health insurance and related insurance solutions in states with legal medical marijuana programs. With a robust infrastructure covering various insurance lines, including health, life, and fixed annuities, Novus is a leading health insurance carrier, using two key indicators to gauge value and performance. The Benefit Monetization Ratio measures the annual total of monetized policies, offset by the operating cost ratio, a Balance Sheet line item derived from Net Asset Value and calculated to the Price Book Value. Novus' medical cannabis benefits package operates as an outside developer. It does not engage in any activities related to the cultivation, handling, transportation, growth, extraction, dispensing, sale, marketing, vending, delivery, supply, circulation, or trade of cannabis or any substances violating United States law or the Controlled Substances Act. The company adheres strictly to state and federal laws and has no intentions to violate them in the future. It is important to note that statements regarding specific products have not been evaluated by the United States Food and Drug Administration (FDA) and should not be interpreted as intended to diagnose, treat, cure, or prevent disease. The information provided in press releases and product labels is for informational purposes only and should not be considered a substitute for advice from qualified healthcare professionals. Novus respects the individual transactions involving cannabis, which are solely between state-licensed dispensaries and registered patients. However, it's worth noting that state laws may conflict with the federal Controlled Substances Act. The current administration has indicated that federal law enforcement agencies will not prioritize prosecuting those complying with state-designated laws concerning medical marijuana usage and distribution. Nevertheless, changes in government policies and consolidation could impact the provider network, and there is no assurance that future administrations will not alter this stance. While Novus does not engage in the harvest, distribution, or sale of cannabis or cannabis-related products, the company could be affected if there were any shifts in enforcement by federal or state governments concerning existing laws. Such changes could result in significant financial implications for Novus and other industry players. Forward-Looking Statements This release includes forward-looking statements, which are based on certain assumptions and reflect management's current expectations. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. Some of these factors include general global economic conditions; general industry and market conditions and growth rates; uncertainty as to whether our strategies and business plans will yield the expected benefits; increasing competition; availability and cost of capital; the ability to identify and develop and achieve commercial success; the level of expenditures necessary to maintain and improve the quality of services; changes in the economy; changes in laws and regulations, includes codes and standards, intellectual property rights, and tax matters; or other matters not anticipated; our ability to secure and maintain strategic relationships and distribution agreements. Dilution, if any, would be for the purposes of management taking stock in lieu of cash salary. Novus disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Additionally, this press release that is not statements of historical fact may be considered to be forward-looking statements. Written words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the near future. Investor Contact Information Investor Website 855-228-7355 Email: pr@getnovusnow.com Contact Details Novus Acquisition Frank Labrozzi +1 305-467-6699 frank@ndev.biz Company Website https://getnovusnow.com/

June 04, 2024 08:00 AM Eastern Daylight Time

AGC Biologics Completes Copenhagen Campus Expansion, Doubling Single-use Mammalian Bioreactor Capacity at Site

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced at BIO International the completion of its new manufacturing building at the AGC Biologics Copenhagen campus. The completed work doubles the site’s single-use bioreactor capacity for mammalian services and allows it to produce 150 more batches of drug product each year. The expansion adds 19,000 m2 of space in an ultramodern building that houses a large manufacturing floor, expanded quality control and process development lab space, utilities to support all operations and prevent outages caused by natural disasters, and a fully dedicated warehouse to serve the entire AGC Biologics Copenhagen campus. The new AGC Biologics Copenhagen manufacturing building is already in production with its first customer, a phase II/III clinical product. AGC Biologics announced the planned expansion in November 2020, investing roughly $200 million into the work. One-of-a-kind single-use manufacturing offering The new manufacturing area offers 8 x 2,000 L single-use bioreactors with two seed trains, as well as two independent downstream suites – [CW1] more than doubling the existing capacity offered at this site for mammalian-based projects. AGC Biologics Copenhagen is now one of the only sites in the world with multiple single-use bioreactor systems of this magnitude capable of producing batches at high-levels of clinical and commercial production. Further, for developers needing to transfer in an existing process, AGC Biologics Copenhagen’s multiple single-use suites give the site greater flexibility to take on technical transfers and perform like-for-like process and knowledge activities for products entering the facility, eliminating lag time associated with onboarding a new CDMO. AGC Biologics has been a leader in single-use technology over the last decade, and it is one of the largest CDMO networks in the industry offering flexible and scalable single-use bioreactors systems. The news comes after AGC Biologics announced an end-to-end protein biologics drug product partnership with Dutch-based BioConnection in late May. The alliance provides a secure and full-service “gene-to-vial” offering for biopharma developers with drug substance development, manufacturing and aseptic fill and finish capabilities for drug products. “AGC Biologics Copenhagen site continues to be one of the most active in our network with all the necessary commercial approvals – FDA, EMA, HCA, PMDA, ANVISA etc. – and we are more than happy to offer the capacity and capabilities our current and future customers will look for with this completed expansion,” said Christoph Winterhalter, CBO, AGC Biologics. “The expansion, combined with our new drug product alliance, demonstrates AGC Biologics’ agility to meet all the needs developers may have, from pre-clinical through commercial.” AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems. It has a gold EcoVadis Sustainability Rating for its environmental, health and sustainability practices. “I am extremely proud of the work and collaboration of everyone at our site over the last several years, it is truly remarkable to see what we can accomplish by working together. We are eager to offer more of the important capabilities the industry is looking for to support patients in need,” said Andrea C. Porchia, General Manager, AGC Biologics Copenhagen. To learn more about AGC Biologics Copenhagen, visit www.agcbio.com/facilities/copenhagen. For more information about AGC Biologics’ global CDMO services go to www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

June 04, 2024 12:00 AM Pacific Daylight Time

Mphasis and Classiq Partner to Drive Quantum Innovation

Classiq Technologies

Mphasis, (BSE: 526299; NSE: MPHASIS), an Information Technology (IT) solutions provider specializing in cloud and cognitive services, today announced its strategic partnership with Classiq, a leading quantum software company to demonstrate and commercialize industry solutions powered by Quantum. The strategic partnership aims to accelerate the adoption of quantum solutions for enterprises by integrating them into its operations. The collaboration is committed to fostering innovation and redefining technological boundaries and paving the way for a quantum-powered future. Classiq leads in quantum computing software and has developed a platform for faster and more efficient quantum algorithm design. Mphasis will focus on building industry solutions in sectors such as BFSI, Lifesciences, Healthcare, Supply Chain & Logistics, Chemistry, utilizing these advanced algorithms. By leveraging Classiq’s quantum platform, Mphasis will develop industry-specific intellectual properties (IPs) and will also jointly market and implement customer IPs, execute customer projects, and provide support for the commercialization of Classiq’s platform and IPs. Additionally, Mphasis’ Quantum Initiative, launched in 2020 within the Applied R&D division, NEXT Labs, aims to facilitate our client's transition to the quantum era. The adoption model comprises awareness-building, assessment, and consulting workshops, as well as the development and implementation of quantum solutions in key domains such as optimization, artificial intelligence, simulation, and cybersecurity. Within the realm of quantum computing, the company’s priorities include applied research, the creation of industry-specific solutions and intellectual properties, thought leadership dissemination, building robust partnerships, and leveraging a design thinking approach to drive adoption. “We are thrilled to announce our collaboration with Classiq and leveraging their expertise to unlock the vast potential of quantum computing. This partnership enables us to combine our industry knowledge with cutting-edge quantum technology, to innovative solutions tailored to our clients' needs. Together we hope to lead the way in initiating and implementing state-of-the-art quantum solutions that redefine the boundaries of our field," said Srikumar Ramanathan, Chief Solutions Officer, Mphasis. "Classiq is proud to be partnering with Mphasis to support scalable enterprise quantum computing software development. Together we combine depth of industry domain knowledge and quantum expertise with the technology needed to implement sophisticated optimized quantum computing programs for our clients," said Nir Minerbi, CEO and Co-Founder, Classiq Technologies. By synergizing Mphasis' domain expertise with Classiq's quantum computing acumen, the collaboration is poised to unlock newer possibilities and redefine industry benchmarks. Quantum computing's ability to tackle previously unsolvable problems opens doors for entirely new discoveries and innovations. National Institute of Standards and Technology’s report states that quantum computing could lead to breakthroughs in areas like materials science, drug discovery, and financial modelling. McKinsey & Company estimates a $106B potential quantum technology market size by 2040. The alliance between Mphasis and Classiq represents a fusion of expertise and innovation, with Classiq's cutting-edge quantum development platform complemented by Mphasis' extensive industry knowledge. Together, the companies aim to pioneer groundbreaking quantum solutions that will reshape sectors primed for transformative change. Classiq’s platform enables both beginner and expert designers to rapidly generate, analyze, and execute quantum circuits. The collaboration reflects the shared dedication of Mphasis and Classiq, showcasing a commitment to pioneering quantum computing applications across diverse industry sectors. Apart from this, in June 2021, Mphasis along with the Government of Alberta, and the University of Calgary signed an MoU to announce the launch of the world-leading Quantum City - Canada. The strategic partnerships were to accelerate talent development and the development of a quantum computing ecosystem in Calgary, driving R&D in the technology sector. In June 2022, Mphasis deepened its commitment to Canada by announcing a delivery center in Calgary, opening the center in Alberta for business. The Mphasis business ecosystem was positioned to reinforce the region's reputation as a leading hub for digital transformation, AI, quantum computing, and more, and contribute to Canada's growing digital sector. About Mphasis Mphasis’ purpose is to be the “Driver in Driverless Car” for Global Enterprises by applying next-generation design, architecture, and engineering services, to deliver scalable and sustainable software and technology solutions. Customer centricity is foundational to Mphasis, and is reflected in the Mphasis’ Front2Back ™ Transformation approach. Front2Back™ uses the exponential power of cloud and cognitive to provide hyper-personalized (C= X2C2TM =1) digital experience to clients and their end customers. Mphasis’ Service Transformation approach helps ‘shrink the core’ through the application of digital technologies across legacy environments within an enterprise, enabling businesses to stay ahead in a changing world. Mphasis’ core reference architectures and tools, speed and innovation with domain expertise and specialization, combined with an integrated sustainability and purpose-led approach across its operations and solutions are key to building strong relationships with marquee clients. Click here to know more. ( BSE: 526299; NSE: MPHASIS ) About Classiq Classiq Technologies, the leading quantum software company, provides an all-encompassing software platform (IDE, compiler and OS) with a single point of entry into quantum computing, from algorithm design to execution. Tailored to all levels of developer proficiency, Classiq aims to democratize access to quantum computing with software that equips customers to take full advantage of the quantum computing revolution. A low-code development environment that automates quantum programming ensures that a broader range of talents, including those with backgrounds in AI, ML and linear algebra, can harness quantum computing without requiring deep, specialized knowledge of how to program quantum computer hardware. Classiq also works closely with advanced computation hardware providers providing software for use with quantum computers, HPC and quantum simulators. Backed by powerful investors such as HPE, HSBC, Samsung, Intesa Sanpaolo and NTT, Classiq’s world-class team of scientists and engineers has distilled decades of quantum expertise into its groundbreaking software development platform. Follow Classiq on LinkedIn, X (formerly Twitter) or YouTube, join the Slack community, or try the Classiq platform. Contact Details Rainier Communications Michelle Allard McMahon +1 781-718-3248 classiqPR@rainierco.com Mphasis Corporate Communications Deepa Nagaraj +1 646-424-5160 deepa.nagaraj@mphasis.com Mphasis Corporate Communications Sumana Bhat +91 99029 80980 sumana.bhat@mphasis.com Company Website http://www.classiq.io/

June 04, 2024 02:04 AM Eastern Daylight Time

Candel Therapeutics (NASDAQ: CADL) Reports Positive Data From Phase 2 Trial Of CAN-2409 In Borderline Resectable Pancreatic Cancer

Candel Therapeutics

By Jeremy Golden, Benzinga Clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL) reported updated survival data from its randomized phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer. Pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. The disease accounts for approximately 3% of all cancers, with an estimated 64,050 patients diagnosed in 2023. The randomized, controlled clinical trial is specifically looking into the safety and efficacy of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection – if possible – in borderline resectable pancreatic ductal adenocarcinoma (PDAC). Very encouraging results were recently reported by the Needham, Massachusetts-based company. Patients reached an estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in PDAC. At 24 months, the survival rate was 71.4% in CAN-2409 treated patients compared to only 16.7% in the control group after chemoradiation. Thus, prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable PDAC. Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients in the randomized control SoC chemotherapy group remained alive at the data cut-off (50.6 months). No new safety signals were observed, providing further support that multiple injections of CAN-2409 are generally well tolerated. Additionally, there were no dose-limiting toxicities or cases of pancreatitis reported. Previous analysis of resected tumors showed dense aggregates of immune cells – including CD8+, cytotoxic tumor-infiltrating lymphocytes and dendritic cells – in PDAC tissue after CAN-2409 administration. This reinforces the potential of CAN-2409 to activate a robust antitumoral immune response in patients with cancer also in ‘cold’, immunosuppressive tumors like PDAC. “Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed,” said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. “We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation.” Candel’s most advanced viral immunotherapy candidate, CAN-2409, is an investigational off-the-shelf, replication-defective adenovirus designed to induce an individualized, systemic immune response against the tumor. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. More than 1,000 patients have been dosed with CAN-2409 to date, with a favorable reported tolerability profile and proof of concept in each indication that the company is currently pursuing. CAN-2409 is injected directly into the tumor or target tissue using a localized injection method that is akin to the standard approach for in situ vaccination to elicit an immune response against the injected tumor and uninjected metastases. Long-term survival data in PDAC was recently updated with eight months of further follow-up since the first analysis was presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting. Based on the data presented at SITC, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to Candel Therapeutics for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC in December 2023. More recently, the FDA also granted Orphan Drug Designation. “The failure of conventional immunotherapy to improve outcomes in pancreatic cancer is attributed to the highly immunosuppressive tumor microenvironment, which is largely devoid of immune cells,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “The immunological changes induced by CAN-2409, evident in the pancreatic tissue and the peripheral blood after administration, suggest that CAN-2409 is able to change the balance between the tumor and the patient’s anti-tumor immune response, which can convert progressive cancer into a chronic disease associated with improved survival.” Featured photo by National Cancer Institute on Unsplash. Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

June 03, 2024 08:30 AM Eastern Daylight Time

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News Release

Sector Spotlight: Orphan Drug Developers With Significant Upside

RazorPitch CRDL, KNSA

The biotech sector is finally beginning to recover following a two year stretch of underperformance that was largely driven by rising interest rates and other macro factors. Biotech has a track record of strong recoveries, with the sector typically seeing double-digit gains after a downturn. This is something investors shouldn’t ignore. This recent turnaround can be credited to a robust increase in fundraising efforts and an uptick in IPOs, reaching levels not seen since the peak of the mid-pandemic market boom. According to the Financial Times, drug developers raised $6 billion in equity capital markets in January, the largest total since February 2021 – a period when biotech stocks hit their all-time high. Moreover, the SPDR S&P Biotech ETF (XBI) returned 28.7% over the past six months alone, clearly illustrating investors' rising confidence in the biotech rebound. Identifying biotech stocks with the potential to deliver superior returns is no easy feat. There are specific milestones that companies can achieve to signal positive momentum to investors. For example, smaller biotech companies may have received the nod from regulatory authorities such as the FDA, or new breakthroughs from clinical trials, to offer a compelling investment opportunity. With that in mind, two stocks that investors should consider looking at are Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) and Kiniksa Pharmaceuticals (NASDAQ:KNSA). Cardiol Therapeutics lead product is CardiolRx™, a small molecule therapy that appears on track to bring major disruption to the pericarditis market. CardiolRx™ received a vote of confidence as it was granted Orphan Drug Designation (ODD) by the FDA for the treatment of pericarditis back in February, illustrating the potential of the drug. Apart from providing a seven-year term of market exclusivity upon final FDA approval, the ODD also positions Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees, and certain tax credits. The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. There are approximately 160,000 cases of recurrent pericarditis in the U.S. annually, which includes 38,000 cases with a recurrence. Having secured FDA approval, Cardiol Therapeutics is an exemplary company likely to attract biotech investors seeking assurance in smaller firms. While the stock had a significant rally on the backdrop of this news and continues to show strength, we believe that there is still potential for further upside. Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) is expected to release topline data in June for its Phase 2 MAvERIC-Pilot clinical trial, which if positive, could unlock significant shareholder value. Several analysts have already indicated that they are highly optimistic that the data could be a catalyst, with one analyst noting that “CardiolRx’s potential to be a safe, new approach to RP (recurrent pericarditis) treatment is underappreciated.” CardiolRx™ stands out when compared to the only FDA-approved therapy because it is administered orally and expected to be offered as a first-line therapy for pericarditis, opening it up to an even bigger opportunity as it could be prescribed at the first occurrence. Orphan drugs have become lucrative business opportunities because these drugs command premium drug pricing, with the average price for an orphan drug at $32,000 per year per patient according to a 2021 study published in the journal Rare Diseases & Journal of Orphan Drugs. That could explain why analysts who have been tracking CRDL are so bullish on the stock. For instance, Joe Gantoss of Chimera Research Group says he won’t be surprised to see Cardiol’s price break past the 3-year high at $4.96, while analyst Vernon Bernardino of H.C. Wainwright & Co. reiterated their Buy rating and issued a $9.00 price target. That would imply that Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) has a potential upside of about 300% from its current share price. Kiniksa Pharmaceuticals (NASDAQ:KNSA) offers some insight into the revenue potential of an orphan drug that treats recurrent pericarditis. So far, KNSA has had a great run, gaining about 36% over the past year and trading at about $18.00 per share despite challenges in the sector. It is currently valued at $1.3 billion. Kiniksa’s portfolio of assets includes ARCALYST®, the first and only FDA-approved therapy for recurrent pericarditis. For some context, the FDA granted Breakthrough Therapy designation to ARCALYST® for recurrent pericarditis in 2019; the FDA granted Orphan Drug exclusivity to ARCALYST® in March 2021 for the treatment of recurrent pericarditis and a reduction in the risk of recurrence in adults and pediatric patients 12 years of age and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. Sales of ARCALYST® were $38.5 million in 2021; $122.5 million in 2022; $233.2 million in 2023 further reaffirming the massive revenue potential for treating recurrent pericarditis. For the first quarter of 2024, ARCALYST® sales were $78.9 million representing 85% year-over-year growth. Furthermore, since its launch in April 2021, approximately 2,000 prescribers have written ARCALYST® prescriptions for recurrent pericarditis, illustrating the massive demand for effective recurrent pericarditis therapies. Going forward, Kiniksa anticipates that it will bring in between $370 million and $390 million in 2024, up from the earlier guidance of $360 million to $380 million. The revised outlook represents roughly 63% year-over-year growth at the midpoint. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

June 03, 2024 07:00 AM Eastern Daylight Time

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