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Tonix Pharmaceuticals Awarded potential 34 million dollar Contract with U.S. Department of Defence

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share exciting news about a significant achievement for the company. Tonix Pharmaceuticals has been awarded a potential contract worth up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense. This contract aims to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections, thereby enhancing the medical readiness of military personnel in biological threat environments. Dr. Lederman explained that Tonix’s program will concentrate on the optimization and development of its TNX-4200 program. The goal is to develop an orally available CD45 antagonist with broad-spectrum efficacy against various viral families through extensive preclinical evaluation. The program is expected to establish essential physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission, ultimately funding a first-in-human Phase 1 clinical study. The agreement with DTRA is a strategic move to address the DoD’s objective of protecting U.S. Joint Forces from potential biological weapon threats. The DoD announced in December 2022 that it aims to move beyond the traditional ‘one bug, one drug’ approach and is seeking broad-spectrum drugs, as predicting which viruses or how many may be deployed in a biological threat scenario is challenging. Dr. Lederman emphasized that the collaboration with DTRA underscores Tonix Pharmaceuticals' commitment to advancing medical readiness and protection for military personnel. By developing a broad-spectrum antiviral agent, Tonix aims to provide a versatile and robust solution to potential viral threats, enhancing the preparedness and resilience of the U.S. military in diverse and unpredictable biological threat environments. The TNX-4200 program’s focus on creating an effective, orally available antiviral agent highlights Tonix’s innovative approach to addressing complex medical challenges. The successful development of this broad-spectrum antiviral could significantly impact the way viral infections are managed in military and potentially civilian populations, offering a proactive measure against a wide array of viral threats. Tonix Pharmaceuticals continues to be at the forefront of medical innovation, dedicated to developing cutting-edge solutions that meet the evolving needs of the healthcare and defense sectors. The support from the DoD through this substantial contract is a testament to the potential and importance of Tonix’s TNX-4200 program in safeguarding the health and readiness of military personnel against biological threats. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 19, 2024 12:48 PM Eastern Daylight Time

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News Release

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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News Release

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

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

News Release

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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University Compounding Pharmacy Announces Rebrand to MediVera Compounding Pharmacy™

MediVera

University Compounding Pharmacy, a leader in personalized medicine since 1999, today announced it is rebranding as MediVera Compounding Pharmacy™. The rebrand comes at a time when the company is growing strongly due to the introduction of new product offerings, nationwide expansion, and the successful differentiation of its quality products and services. Despite the name change, the company’s ownership and passionate team remain the same, ensuring continuity in the high-level service and exceptional care that healthcare providers and patients have relied on for more than two decades. Over the past few years, the company has seen its revenue grow substantially. New product offerings, nationwide expansion, and strong market positioning through differentiated quality products and services, such as the Impressed Advantage program, have enabled the company to double its revenue from 2022 to 2023. Growth is anticipated to accelerate this year, with the company expecting to double revenue year-over-year once again. “Differentiation is and will continue to be an important growth driver for our company. With the Impressed Advantage customer service program, we are making the prescription process easier, faster, and more convenient for both doctors and their patients,” said Bradley McCloskey, PharmD, CEO. “As we continue to launch more product offerings and expand into more states within the next few months, 2024 is poised to become a year of strong growth as we expand our footprint into 14 additional states.” For more information about MediVera Compounding Pharmacy and its services, please visit mediverarx.com or contact Laurie Malseed, Marketing Specialist, at laurie@mediverarx.com or 937-242-0430. About MediVera Since its inception in 1999, MediVera Compounding Pharmacy™ (formerly University Compounding Pharmacy) has been dedicated to providing personalized medicine. With a focus on quality and innovation, MediVera Compounding Pharmacy™ continues to set industry standards, offering tailored solutions to meet the unique needs of healthcare providers and patients. MediVera Compounding Pharmacy™ is currently licensed in and ships to the following 33 states: AZ, CN, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NY, OH, PA, RI, SC, SD, TN, VA, VT, WA, WI, WY. Contact Details MediVera Compounding Pharmacy Laurie Malseed +1 937-242-0430 laurie@mediverarx.com

July 16, 2024 09:00 AM Eastern Daylight Time

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