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Mainz BioMed Seeks FDA Breakthrough Device Designation for Advanced Colorectal Cancer Test

Mainz Biomed N.V.

Mainz BioMed CEO Guido Baechler joined Steve Darling from Proactive to announce the company has submitted an application to the U.S. Food and Drug Administration requesting Breakthrough Device Designation for its innovative non-invasive Next Generation colorectal cancer screening product. This product incorporates a novel portfolio of mRNA biomarkers. Achieving this designation could potentially expedite the approval process, significantly benefiting early cancer detection efforts. Baechler emphasized that the regulatory submission is backed by consistently strong results from the company's clinical studies, ColoFuture and eAArly Detect, as well as data from a comprehensive pooled study encompassing both the European and U.S. cohorts, which were presented at ASCO 2024. These studies have culminated in the final configuration of the Next Generation Test. This test integrates the Fecal Immunochemical Test with proprietary mRNA biomarkers and is enhanced by an advanced AI and machine learning algorithm. This integrated approach is set to be employed in the FDA premarket approval study. The Next Generation Test configuration was rigorously evaluated in a clinical setting involving 295 subjects from 21 specialized gastroenterology centers across the United States. The results underscored the exceptional efficacy of Mainz Biomed’s multimodal screening test, which allows for precise differentiation among colorectal cancer, advanced adenomas, non-advanced adenomas, and samples with no pathological findings. The FDA’s Breakthrough Devices Designation program is designed to accelerate the development, assessment, and review of medical devices and combination products that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This designation for Mainz BioMed's colorectal cancer test could pave the way for quicker market access and wider availability of this critical diagnostic tool. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 19, 2024 12:38 PM Eastern Daylight Time

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LeadStar Marketplace Unleashes Groundbreaking Enhancements to Its Lead-Generation Platform

AmeriLife

LeadStar Marketplace, the proprietary, private leads platform created exclusively for AmeriLife -affiliated agents, announced today the launch of LeadStar 2.0, which features significant enhancements to its robust platform, designed to revolutionize how licensed insurance agents acquire quality leads for consumers seeking Medicare, Medicare Advantage, Affordable Care Act (ACA), and Final Expense (FE) insurance coverage. LeadStar 2.0 is available immediately to all existing customers. In collaboration with its customer base and affiliated health agencies, the LeadStar team has listened to what sales professionals value in today’s lead generation landscape, resulting in the upgraded LeadStar 2.0 platform. The platform’s enhanced approach to supplying leads features an extended lead catalog, multi-media channel capabilities, and advanced optimization technologies to set a new standard for lead generation efficiency and effectiveness. “At LeadStar, we are dedicated to pushing the boundaries of what's possible in lead generation,” said William DeCourcy, Chief Lead Generation Officer for AmeriLife. “These enhancements are a testament to our ongoing efforts to innovate and improve our services. We believe the new features will empower our clients to succeed even more in their marketing and sales endeavors.” The enhanced LeadStar 2.0 platform is designed to meet the demands of the evolving health and life insurance marketplace, ensuring licensed agents connect with the right prospects more efficiently than before. Extended Lead Catalog The extended lead catalog allows users to diversify and target a more comprehensive network of potential customers across various multimedia platforms and demographics. This expansion means agents can connect with the right prospects at the right time, which should dramatically increase conversion rates. LeadStar 2.0’s expansion targets social media, inbounds, direct mail, and transfers with real-time data across Medicare, MA, ACA, and FE. This deeper level of marketing funnel visibility offers more substantial visibility to each lead by understanding their customer journey before the sales process begins. Expanded Multimedia Channel Supply LeadStar 2.0 integrates a wealth of multi-media channel leads into its platform. Agents can now connect with potential customers through multiple touchpoints, including social media, email, and mobile, all within a unified system tailored to meet specific needs or strategies. This holistic approach streamlines the lead generation process, enhances user engagement and interaction, and aims to provide the lowest CPA possible. More Substantial Lead Delivery Moreover, LeadStar 2.0 introduces enhanced optimization capabilities to its platform. Advanced algorithms and machine learning power the platform and offer more intelligent lead matching and predictive lead scoring. These features ensure clients receive relevant and high-potential leads, reducing the time and effort they will spend on lead qualification and follow-up. For more information about LeadStar and the enhanced lead-generation platform, please email leadstar@leadstarhub.com or request access at LeadStarHub.com. ### About LeadStar LeadStar is an industry-leading enterprise leads program that delivers the compliant, reliable, and performative leads that today’s health and life insurance agents need to grow their books of business and maximize their success. Powered by AmeriLife and exclusively for the company’s affiliated agents, LeadStar’s suite of solutions includes LeadStar Marketplace, LeadStar Connect, and LeadStar Direct. For more information, contact an AmeriLife-affiliated marketing company or visit LeadStarHub.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado Media@amerilife.com Company Website https://amerilife.com/

July 18, 2024 12:00 PM Eastern Daylight Time

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ABVC BioPharma's CEO Discusses New Drug Development and AI Integration

ABVC BioPharma

After successfully completing Phase II clinical trials for their medication to treat Major Depressive Disorder, ABVC BioPharma Inc. and AiBtl BioPharma Inc. are now embarking on a groundbreaking clinical study focused on Depression in Cancer Patients. This new study will integrate AI-driven solutions to address the significant challenge of depression among cancer patients, a condition that often complicates treatment and adversely affects overall quality of life. Dr. Uttam Patil shared with Steve Darling from Proactive that the study aims to gain a deeper understanding of the prevalence and impact of depression in cancer patients. It will explore innovative therapeutic approaches by integrating real-time patient monitoring and enhanced patient analysis through an AI model. This advanced methodology is expected to increase the lead time for clinical trials, utilizing novel and sophisticated treatment protocols. The clinical study will be conducted at the renowned Cedars-Sinai Medical Center, involving cancer patients who experience depressive symptoms. By leveraging advanced AI technologies and employing cutting-edge diagnostic and therapeutic techniques, the study aims to monitor and treat depression in participants under meticulous medical supervision. Dr. Patil emphasized that the integration of AI-driven solutions in this clinical study represents a significant leap forward in the treatment of depression in cancer patients. The use of real-time patient monitoring and AI-based analysis is anticipated to provide valuable insights and improve patient outcomes, setting a new standard for clinical trials in this area. The collaboration between ABVC BioPharma and AiBtl BioPharma highlights their commitment to advancing healthcare through innovative solutions. This study is poised to make a substantial impact on the management of depression in cancer patients, offering hope for improved quality of life and better treatment outcomes. Through this pioneering study, ABVC BioPharma and AiBtl BioPharma are at the forefront of integrating technology with healthcare, paving the way for future advancements in the field. The companies are dedicated to utilizing AI to enhance patient care and accelerate the development of effective treatments for depression in cancer patients. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 18, 2024 10:31 AM Eastern Daylight Time

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Tonix Pharmaceuticals receives positive feedback from FDA on Tonmya™ for fibromyalgia management

Tonix Pharmaceuticals

Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the receipt of formal minutes from a pre-New Drug Application (NDA) meeting with the US FDA regarding Tonmya sublingual tablets, which is aimed at managing fibromyalgia. This significant development marks a crucial step forward in the regulatory process for Tonmya™. During the meeting, both the company and the FDA concurred that the proposed data package is comprehensive and sufficient to support the NDA submission. Tonix Pharmaceuticals has reaffirmed its plan to submit the NDA for Tonmya to the FDA in the second half of 2024. If the submission proceeds as planned, it could pave the way for a potential FDA approval in the second half of 2025. Dr Lederman highlighted the promising potential of Tonmya to benefit fibromyalgia patients, a demographic that frequently expresses dissatisfaction with existing treatment options. Many patients currently resort to using off-label treatments, including addictive and detrimental opioids, due to the lack of effective alternatives. The positive outcomes from the pre-NDA meeting underscore the robustness and completeness of the data package that supports the registration of Tonmya for the management of fibromyalgia. Tonix Pharmaceuticals is optimistic about the impact that Tonmya could have on the fibromyalgia treatment landscape. The company's focus remains on advancing this promising therapy through the regulatory process and ultimately providing a new, effective option for patients struggling with this challenging condition. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 18, 2024 10:20 AM Eastern Daylight Time

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Forum Health Breaks into Denver Market with Acquisition of Concierge Functional and Regenerative Medicine Practice

Forum Health

Forum Health, LLC, a nationwide network of integrative and functional medicine providers and a pioneer in personalized healthcare, is expanding into a leading wellness-focused city with its acquisition of RevolutionaryMD in Denver, CO. Learn more about RevolutionaryMD. Renowned for its proclivity for health and wellness and prestigious medical research institutions, Denver is the ideal setting for a clinic rooted in personalized, cutting-edge healthcare. Phil Hagerman, Forum Health CEO: “Dr. Grover’s development of his revolutionary functional, regenerative, and anti-aging medical center aligns perfectly with the Forum Health clinic model, making this expansion a natural fit. His thirty years of success and expertise in central Denver is invaluable as we expand to a new state, enhancing the practice’s availability and offerings for wellness-focused patients.” The founder of RevolutionaryMD center in Cherry Creek North, Fred Grover, Jr., MD, is a Board-Certified Family Physician with training and certifications in Integrative, Functional, and Anti-Aging Medicine. He brings a wealth of experience and expertise to Forum Health's expanding network. Fred Grover Jr., MD, RevolutionaryMD Founder: “I’m excited to join Forum Health and grow our services and availability to help patients find a proactive approach to healthcare. We embrace the future of medicine by offering a robust preventative care model to treat the root cause of chronic conditions.” In addition to traditional testing, RevolutionaryMD offers genomic panels, advanced cardiovascular and cancer screening, inflammatory, and nutritional testing. It also employs AI for precise, personalized recommendations, moving beyond the depersonalized, often suboptimal outcomes of standard allopathic medicine. RevolutionaryMD has pioneered the concierge approach of functional medicine, advancing personalized healthcare with the latest treatments in: Anti-Aging and Regenerative Medicine for Improved Healthspan and Lifespan Bioidentical Hormone Replacement Therapy and Restoration Sexual Health and Wellness Aesthetic Dermatology Mind and Body Balancing Through Brain Health Modalities Integrated Ketamine and Sound Therapy for Depression IV Therapy for Post-COVID Syndrome, Inflammation and Healthy Mitochondrial Function Dr. Grover's dedication to functional and integrative medicine is evident in his role as an assistant clinical professor at the University of Colorado, Denver, his Board Certifications in Anti-Aging and Integrative Holistic Medicine, and his authorship of "Spiritual Genomics" and "Awakening Gaia." About Forum Health, LLC Forum Health, LLC is a nationwide provider of personalized healthcare steeped in the powerful principles of functional and integrative medicine. Our providers take a root-cause approach to care exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Members have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships. For more, visit www.forumhealth.com. Contact Details Britt Wittelsberger +1 410-852-0738 bwittelsberger@forumhealth.com Company Website https://forumhealth.com

July 18, 2024 08:50 AM Eastern Daylight Time

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Freelance jobs grow despite AI, finds new data from Freelancer.com

FREELANCER.COM

Freelancer.com (ASX: FLN), the world’s largest freelancing and crowdsourcing marketplace by number of users and jobs posted, today released its quarterly Fast 50 Index for Q2 2024 based on data from 251,000 jobs posted to the platform. Computer Security (up 27.1% from 868 to 1,103 jobs) emerges as the fastest-growing freelance skill on Freelancer.com, based on job postings across more than 2,000 skill categories from April 1 to June 30, 2024. This trend in cybersecurity skills suggests more small-to-medium businesses are turning to freelancers for cyber security support, further backed by Network Administration (up 9.9%, from 1,229 to 1,351) also placing in the top 25 fastest growing jobs on the platform. The data also shows no negative impact on generative AI tools on freelance jobs, evident in the growth of Writing, Business Service, and Legal Skills seen in this quarter’s Fast 50 report, all of which were predicted to decrease with the rise in generative AI. PDF writing (up 26.7%, from 2,533 to 3,210) was the second fastest growing job, followed by third place being Microsoft Word (up 23.9%, from 3,368 to 4,173) projects which are also associated with content writing. Writing job Copy Typing came in at the 16th place, growing 11.6% (from 4,428 to 4,941). Legal jobs, which were expected to have been ‘at threat’ to AI, have also increased (up 12.0% from 1,138 to 1,274), as well as Legal Research (up 10.8% from 917 to 1,016). In addition to the index, Freelancer.com ’s annual AI survey, which surveyed more than 4,100 workers globally, investigated AI impact on income and the initial results are shedding light on earnings. When asked how the introduction of AI tools have impacted earnings, more than half of workers (52.5%) reveal they’re earning either the same or more. One fifth (19.2%) say that they’re earning a lot more since generative AI tools were introduced, while only one sixth (17.7%) admit to earning less. “AI is creating more jobs than it takes. While many critics continue to speculate which jobs will be made redundant with AI tools, the data shows that freelance jobs which are labeled as the ‘most at risk to AI disruption’ are in fact growing. The preliminary results from our AI survey also dispel the myth that freelancer are earning less since the introduction of generative AI as more three quarters of workers we surveyed are either earning the same or earning more, with a subset taking advantage of AI and earning a lot more.” said Matt Barrie, Chief Executive at Freelancer.com. Cybersecurity threats are on the rise across all organizations, but are particularly harmful for small-to-medium sized businesses (SMBs) which have little-to-no security expertise and usually minimal protection. As a result, businesses turned to freelancers for help. In 2Q24, Computer Security jobs ranked as the fastest growing skills (up 27%), indicating there has been an uptick in cyber security threats targeting SMBs. Many of the projects posted throughout the quarter require help with network security, security assessments to identify potential vulnerabilities, and creation of cyber security response play books. General business services are also increasing on the platform as more employers are hiring freelancers to support their small businesses. A clear indication of this is the popularity of Market Research and Telemarketing jobs coming in as the fourth and fifth fastest growing skills in Q2 2024, up by 21.1% (from 1,525 to 1,859) and 19.4% (from 1,177 to 1,405), respectively. Other business related skills grew in Q2 2024, including Sales (up 15.5% from 3.467 to 4,005), Lead Generation (up 12.2% from 1,802 to 2,021) and Business Plans (up 10.9% from 1,197 to 1,328). A sudden increase in General business services means that many of the new businesses, which are usually started at the beginning of the year, now require further assistance in helping grow and scale their business. Fastest Falling Skills for Q2 2024 The main category of jobs that fell in Q2 2024 was eCommerce related jobs, which saw a significant increase in Q1 2024. Shopify Templates, ranked as the fastest falling skill and was down by 13% (from 1,476 to 1,284). CSS, which is commonly used in website development, was also down (11.8% from 9.486 to 8,368). Both WooCommerce (from 1.072 to 952) and Shopify (2,545 to 2,269) also fell in the quarter. The easing of eCommerce jobs in this quarter was mainly due to seasonality. Typically, entrepreneurs will start a business at the beginning of the year, requiring help to set up their websites or eCommerce platforms. From there, the entrepreneur either pivots to hiring freelancers for other business services, such as sales or research which we’ve seen in Q2 2024 fastest growing jobs, or are equipped with enough to run their business without any further help. Fastest Growing Overall Job The most popular online freelancing job by total volume is currently Graphic Design with almost double the amount of projects than the other top skills. Graphic Design is followed by PHP (programming), Photoshop, Website Design and HTML (programming). These are typically the best skills for any new freelancer to focus on initially when starting their freelancing journey. How Electronic Repairs Are Becoming the Fastest Growing Skill Globally Electronic Repairs has emerged as one of the fastest-growing job categories on the platform over the past year. In Q2 2024, it ranked 19th among the top 25 fastest-growing jobs, with a 10.7% increase (from 14,945 to 16,548 jobs). However, its most impressive growth is evident in the year-over-year comparison, where Electronic Repairs jobs surged by 162%, from 6,315 in Q2 2023 to 16,548 in Q2 2024. Electronic Repairs are in-person jobs where freelancers are deployed across select countries and cities to fix laptops, printers and computer hardware as part of the Freelancer Global Fleet Program. ##### Freelancer.com Fast 50 The Freelancer.com Fast 50 index is the world’s largest forward indicator of trends in online jobs related to industries, technologies, products, and companies. The data is based on 251,000 jobs posted to the Freelancer.com platform between 1st April to 30th June 2024. Data: Fast 50 Quarterly Index – Q2 2024 2023 Q2 v 2024 Q2 Fastest Growing Jobs for Q2 2024 Fastest Falling Jobs for Q2 2024 About Freelancer Twelve-time Webby award-winning Freelancer.com is the world’s largest freelancing and crowdsourcing marketplace by total number of users and projects posted. More than 74 million registered users have posted over 23.8 million projects and contests to date in over 2,000 areas as diverse as website development, logo design, marketing, copywriting, astrophysics, aerospace engineering and manufacturing. Freelancer owns Escrow.com and Loadshift. Freelancer Limited is listed on the Australian Securities Exchange under the ticker ASX:FLN and is quoted on OTCQX Best Market under the ticker FLNCF. Contact Details Freelancer.com Marko Zitko +1 650-800-6863 mzitko@freelancer.com

July 18, 2024 07:00 AM Eastern Daylight Time

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Ascend Wellness CEO Outlines Company's Growth Strategy and Market Expansion Plans

Ascend Wellness Holdings

Ascend Wellness CEO John Hartman joined Steve Darling from Proactive to discuss the company’s current status and future plans. Ascend Wellness, a prominent multi-state cannabis operator in the United States, has established its presence primarily in the Midwest, Northeast, and Mid-Atlantic regions. The company, now in its fifth year of operation, has expanded its footprint to seven states, including Ohio and Pennsylvania, both of which are transitioning to recreational cannabis use. During the interview, Hartman emphasized Ascend Wellness's strategic approach of focusing on select markets and maximizing the number of dispensaries allowed in each state. This targeted strategy is aimed at optimizing market penetration and ensuring robust growth. Drawing on his extensive background in wholesale, retail, and manufacturing, Hartman highlighted the company's emphasis on effective capital deployment and growth through mergers and acquisitions (M&A). A significant development discussed was the refinancing of a term loan due in August 2025. This financial maneuver provides Ascend Wellness with a five-year runway to concentrate on growth initiatives. The refinancing is expected to enhance the company's balance sheet management, providing greater financial stability and flexibility. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 17, 2024 10:42 AM Eastern Daylight Time

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Briefly Bio launches with $1.2m funding to help scientists reproduce complex experiments

Briefly Bio

Science is in a reproducibility crisis. In preclinical research, it’s estimated that over 50% of efforts to reproduce experiments fail, costing the industry over $50bn each year. Solving this problem, techbio startup Briefly Bio has launched with software that makes lab work more reproducible by helping scientists capture and share their work clearly and consistently. With this launch, Briefly Bio has secured a $1.2m pre-seed funding round. It was led by Compound VC, with participation from NP Hard, Tiny VC and angel investors across tech and biotech. Biological experiments have become increasingly complex. With this growing complexity, details that are critical to our shared understanding are often undocumented and lost. This makes scientific collaboration inefficient: lab scientists struggle to reproduce and build on top of each other's experiments; data scientists do not have the necessary context to analyse the data produced in their labs; and automation teams lack all details to build robotic labs. Briefly Bio is tackling this, creating a shared language for experiments that is consistent across scientists, and clear for any collaborator to understand. Their software uses AI to convert existing experiment descriptions into this consistent format, while automatically filling in gaps and spotting errors. This helps capture the value of every experiment that is run, and enables scientists to learn from each other’s work. Briefly was founded by Dr Katya Putintseva, Harry Rickerby and Staffan Piledahl. They have varied backgrounds, through academia, tech, biotech and robotics. Before founding the company, the three worked together at drug discovery startup LabGenius, where they helped build its ML-driven antibody discovery platform. Harry Rickerby, CEO and co-founder at Briefly Bio, commented: “Scientific methods are a bit like software code, they are a set of instructions that define how an experiment should be run. The majority of this ‘code’ is incomplete, since writing up each experiment completely takes a huge amount of effort. Now, with LLMs, there’s a way to make these methods consistent without imposing on a scientists’ workflow. As Github helped software engineers collaborate and build on each other’s code, we think Briefly can help scientists and engineers do the same with their experiments.” With AI and high throughput experimentation, there is an opportunity for huge improvements in the efficiency of scientific discovery. Hundreds of billions of dollars are being invested through startups and big pharma to take advantage. To realise this potential, science needs more consistency and transparency in how these datasets are generated, since the value of any model is a product of the data it has been trained on. Briefly Bio is building this necessary layer of infrastructure to accelerate scientific discovery in biology. “This is a revolution in documenting lab experiments. It is the future of foolproof knowledge-sharing between scientists” said Dr Gena Nikitin, Founder of Miphic. While Dr Maria Anastasina, Wet Lab Head at the Evolutionary and Synthetic Biology Unit, OIST, added: “Briefly has become a core part of our lab's knowledge base and a great help to me in training researchers and lab management”. And Suparna Kumar, PhD student at Weill Cornell commented: “Briefly Bio has become an indispensable part of my lab routine because it helps me save so much time”. Rob Harkness, CTO of Biosero, added: “We're very excited by what Breifly.Bio can offer with their software tools. Inconsistent and incomplete data can compromise research, making it difficult to reproduce experiments and undermining trust in scientific results. Digitalising and automating laboratory operations can address this, but this effort faces challenges of inefficiency and high error rates, primarily due to the diverse formats in which workflows are presented. Briefly.bio addresses this by converting scientific protocols written in natural language into a common and consistent structured format. This facilitates much faster design and implementation of automated systems, ensuring all critical information is captured and utilized effectively. The result is a significant boost in workflow integration, efficiency, and data quality, all of which are crucial for generating reliable experimental results. This leads to more comprehensive and innovative solutions in lab automation that can only help accelerate scientific research.” Shelby Newsad, Investor at Compound, commented: “The crux of successful science lies in consistent and executable methods. Whereas most bio software companies focus on data and its analysis, Briefly goes upstream to the core problem space of reproducibility via protocols. For the first time in science history, this incentivizes scientists to share more of their previously tacit knowledge. The fact that Briefly-made methods can be built and collaborated upon creates unique potential for network effects from their software.” Briefly Bio is creating a future where scientists can stop reinventing the wheel – spending time and resources on experiments that they can’t reproduce. This will enable scientists to produce datasets that will quickly expand our understanding of biology. About Briefly Bio Briefly Bio is the tool to make lab work reproducible. It helps scientists capture, share their experiments clearly and consistently. Briefly is based in London, UK. For more information, visit https://briefly.bio. About Compound VC Compound is a research-centric, thesis-driven investment firm. We are a team of investors, researchers, and operators. We use our domain expertise, network, and prior experiences to help our founders solve previously unsolvable technical problems, communicate these breakthroughs to the world, and scale commercialization. Contact Details Briefly Bio Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://briefly.bio/

July 17, 2024 08:00 AM Eastern Daylight Time

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Medicus Pharma CEO Dr. Raza Bokhari Announces Updated Phase 2 Clinical Protocol Submission to FDA

Medicus Pharma

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma joined Steve Darling from Proactive to announce the submission of a comprehensive and updated Phase 2 Investigational New Drug clinical protocol to the United States Food and Drug Administration (FDA). This protocol aims to non-invasively treat basal cell carcinoma of the skin using micro-needle arrays containing doxorubicin, developed by Medicus Pharma’s wholly owned portfolio company, Skinject, Inc. The submission features significant updates to the clinical protocol, including enhancements to the supporting Chemistry, Manufacturing, and Controls (CMC), along with detailed stability and sterility information. Furthermore, it addresses the clinical non-hold comments previously received from the FDA, ensuring a robust and thorough response to regulatory feedback. Dr. Bokhari shared with Proactive that the revised Phase 2 clinical protocol incorporates innovative elements such as artificial intelligence and confocal microscopy as supplementary endpoints at one of the clinical sites. These advanced technologies are expected to provide deeper insights and improved accuracy in the clinical outcomes. Medicus Pharma believes that this updated protocol is well-positioned to receive FDA approval, paving the way for the commencement of participant randomization potentially before the end of this quarter. This milestone underscores the company’s commitment to advancing innovative treatments for skin cancer and improving patient outcomes through cutting-edge technology and rigorous clinical research. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

July 16, 2024 11:51 AM Eastern Daylight Time

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