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BiVictriX Therapeutics "looking really healthy" after positive first half

BiVictriX Therapeutics PLC

BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) founder and CEO Tiffany Thorn speaks to Thomas Warner from Proactive after the UK-based drug discovery and development company released its interim results for the six months to 30 June 2023. Thorn gives her take on how the business performed during the reporting period, highlighting the nomination of a clinical candidate for the lead programme, BVX001 as well as progress on BVX002 and BVX003. BiVictriX also bolstered its financial position with a successful fundraise, raising over £2 million, supplemented by a £0.5 million R&D tax credit claim. Thorn emphasises the robust financial position of the company, saying that the runway "is looking really healthy... we've got sufficient funds to carry out our near-term objectives." She also mentions growth in the team itself, as it sharpens its focus on the partnering opportunities that she describes as the company's key focus. Looking ahead, the focus lies on advancing program readiness for clinical use, scaling up drug manufacturing, and forging those key business development relationships. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 20, 2023 03:00 AM Eastern Daylight Time

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Scancell CEO hails "exciting" high response rate to melanoma treatment

Scancell Holdings PLC

Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) chief executive Professor Lindy Durrant speaks to Thomas Warner from Proactive to provide an update on the initial phase of the clinical stage biopharmaceutical company's Phase 2 SCOPE trial in advanced melanoma. Professor Durrant gives an overview of the findings so far, saying that in the initial 11 patients they have achieved an impressive 82% overall response rate, surpassing the anticipated 70%. This development could be crucial for metastatic melanoma patients, as previous studies reported only a 50% response rate. She adds that the potential to significantly improve outcomes is especially significant given the rising cases, particularly among young women. While further confirmation is needed in a larger cohort, the data's strength suggests promising results in the broader study. Looking ahead, the trial aims to recruit 43 patients, expecting over 27 respondents, with potential adjustments based on the remarkable initial response rate. Professor Durrant also provides an update on Modi1 vaccine and Scancell's antibody platform. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 20, 2023 03:00 AM Eastern Daylight Time

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Tonix Pharmaceuticals releases positive results from Proof-Of-Concept Study on TNX-102 SL

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to share significant news regarding the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL 5.6 mg for the management of fibromyalgia-type Long COVID. Dr Lederman provided an overview of the study's topline results and the implications for future development. Dr Lederman announced that the study showed a robust effect size in improving fatigue, a key symptom of Long COVID. The results also demonstrated consistent activity trending towards improvements across secondary endpoints, including sleep quality, cognitive function, disability, and patient global impression of change. However, Dr Lederman noted that TNX-102 SL did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at Week 14. Despite this, the proposed mechanism of TNX-102 SL, which aims to improve sleep quality, aligns with recent announcements from the National Institutes of Health (NIH) that sleep quality is a target for future clinical trials in Long COVID. Dr Lederman highlighted that there is currently no approved drug for the treatment of Long COVID, making these findings important for potential future treatments. The company's plan is to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the possibility of a Phase 3 program. They intend to propose a primary outcome measure using the PROMIS Fatigue scale, which is widely recognized and validated for assessing fatigue across various conditions. Dr Lederman also told Proactive the company is committed to meeting potential increased demand for its Tosymra nasal spray 10 mg following GlaxoSmithKline’s planned discontinuation of Imitrex nasal spray 5 mg and 20 mg products after January 2024. This move by Tonix is to be ready in case of possible drug shortages for patients who suffer from migraines. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

September 19, 2023 01:54 PM Eastern Daylight Time

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PathAI Announces Expansion of BioPharma Lab to Provide End-to-End Central Pathology and Histology Services

PathAI

PathAI, a global leader in AI-powered pathology, today announced the expansion of its BioPharma Laboratory Services. Capitalizing on the 30-year history of delivering high quality pathology services in the PathAI Diagnostics clinical laboratory (formerly known as Poplar Healthcare), PathAI offers biopharma partners a comprehensive, GCP/GCLP compliant histology and digital pathology lab to support prospective clinical trials across oncology, liver, and gastrointestinal indications. The lab offers pharmaceutical companies access to unparalleled histological laboratory services and comprehensive operational support, encompassing the full end-to-end tissue processing from kitting and logistics management, tissue processing and staining across H&E, IHC, and special stains; local and remote pathology tapping into PathAI’s network of >500 US board-certified pathologists; and AI-driven analysis from PathAI’s menu of algorithms and clinical trial software. This integrated approach enables the streamlined, proficient, and regulatory-compliant implementation of controlled clinical trials, all within a single facility. PathAI’s BioPharma Lab has a unique combination of capabilities to enable clinical trials where pathology-based endpoints, biomarker classification, and/or superior histology quality are critical to the success of their pharma partners. Over the last two years, the company has already supported Phase 2 clinical trials in NASH, IBD, and breast cancer, as well as oncology neoadjuvant trials. Based on successfully meeting key milestones on quality and turnaround times, PathAI is expanding and scaling its services to new trial indications and partners. The lab adheres to all relevant quality, regulatory, and compliance standards including CAP/CLIA and GCP/GCLP. In addition to full laboratory support for clinical trials, PathAI’s BioPharma Lab supports trials through its AI products and expertise with AI-powered endpoint assessment and patient enrollment. “We don’t just create algorithms, we stay in lock step with our pharma partners to ensure our AI products are integrated into trials appropriately, based on regulatory criteria, to enhance trial quality and efficiency,” said Andy Beck, MD, PhD, CEO of PathAI. The BioPharma Lab’s expertise helps reduce the impact of many challenges associated with clinical trials, including unreliable turnaround times, variable histology, stain or scan/digitization quality, and challenging assessment of histological endpoints. In addition, the lab allows pharma partners the ability to use AI without a heavy lift to implement. The lab offers most major types of instrumentation, with flexible workflows across different scanners, stains, and biopsy types, which improves the quality of clinical trials. Importantly, the services include access to PathAI’s extensive network of over 500 US Board Certified pathologists to perform high quality reading with rapid turnaround time in a cost-effective manner. “During my time running translational sciences in a Top 10 pharma company, I witnessed a strong need for high quality, scalable, and flexible pathology services that can further be combined with the state-of-the-art technology in digital pathology and AI,” said Mike Montalto, PhD, Chief Scientific Officer, of PathAI. “We took a pharma-first approach when establishing this lab and its offerings.” The BioPharma Lab will physically expand in 2024 to allow an increase in sample throughput to accommodate larger scale global phase 3 studies, as well as additional equipment to support a wider range of clinical studies. Learn more about how PathAI’s BioPharma Lab can power your next clinical trial by contacting BD@pathai.com or visiting https://www.pathai.com/clinical-trial-services/. PathAI will be at several upcoming conferences with representatives available to speak about the lab’s capabilities, including ESMO, SCOPE Europe (booth #4), and SCOPE Orlando (booth #206). About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

September 19, 2023 10:00 AM Eastern Daylight Time

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AmeriLife Wealth Announces New Distribution Growth and Wealth Transformation Division

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, today announced the formation of Distribution Growth and Wealth Transformation, a newly created division within AmeriLife Wealth designed to support business development and organic growth, and accelerate the integration of its network of leading distribution companies and wealth advisory firms. “As we break through traditional distribution models and provide holistic solutions to the market we serve, it’s critical that we focus the right talent and resources to help us fundamentally transform the way in which we deliver value,” said Mike Vietri, Chief Distribution Officer of AmeriLife Wealth. “This team will spearhead our strategic focus and enhance our Wealth Distribution Platform, while also capitalizing on selling synergies and opportunities to leverage best-in-class solutions across our platform, better supporting those we serve.” Andrew “Andy” Sheen, most recently senior vice president and head of AmeriLife’s BizRev Group (BRG), will lead the Distribution Growth and Wealth Transformation team, reporting to Vietri. In this newly created role, Sheen will also leverage his considerable industry experience to lead all efforts surrounding AmeriLife Wealth’s market positioning while collaborating with AmeriLife Wealth leaders to deliver best practices, business development strategies, and sales and resource synergies. Sheen joined AmeriLife in December 2020 from Saybrus Partners, where he oversaw product development for the company’s annuity and life distribution. Prior to Saybrus, from 2009 to 2012, Sheen served his first stint with AmeriLife as its director of Financial Services, managing annuity and life product development for the company with its carrier partners. He began his career at CDA of America in various, and increasingly senior, product development, sales, and marketing roles. “I’m thankful to Mike for this opportunity and excited to bring my nearly 20 years of experience on the both carrier and distribution side to this new endeavor,” said Sheen. “‘Growth’ and ‘transformation’ are two sides of the same coin and essential to both accelerating the success of our affiliated partners, but also ensuring they remain one step ahead of consumer demands and the constant changes in our industry.” AmeriLife Wealth Continues to Grow Its Leadership Ranks The establishment of the new division and Sheen’s elevation builds upon significant strategic changes to AmeriLife’s Distribution structure as well as leadership changes within both its Wealth and Health Distribution organizations. In addition to Sheen’s appointment, the following senior roles within AmeriLife Wealth were also announced: Kelly Atkinson has been named Senior Vice President of Distribution Operations and Chief of Staff for AmeriLife Wealth, an expansion of her current role with a strategic focus on supporting Wealth’s growing executive leadership team and priority initiatives. In this expanded role, Atkinson will also continue to support enterprise campaigns and initiatives that span AmeriLife’s Wealth and Health distribution organizations. With Atkinson’s elevation, Crystal Santillanes has assumed an expanded role as Vice President of Distribution Operations. With a focus on driving action and alignment with Distribution goals, Santillanes is accountable for overseeing a variety of enterprise-wide Distribution initiatives and campaigns, in partnership with various functional areas across the company. Santillanes and her team is also responsible for Distribution meetings, events, and incentive programs. Bob Yates has been named Vice President, Distribution Business Analytics. In his new role, Yates will focus on partnering with Wealth and Health Distribution leadership and AmeriLife’s affiliates to maximize the value of available data, providing financial and market analysis, interpreting production results, and forecasting and developing business trend insights to support data-driven strategic planning, business development, and decision making. Yates will continue to collaborate with AmeriLife’s Enterprise Data and Analytics (EDA) team to support enterprise level data collection and reporting as well as ad hoc Distribution analysis needs. Lastly, Christy Appleang, CPA, joins the organization as Vice President, Financial Operations, responsible for leading all budgeting processes as well as developing strategic budgetary policies and guidelines to help meet short and long-term financial goals. Appleang brings 20 years of financial planning and analysis experience to AmeriLife Wealth, most recently serving as Senior Director of Finance for national grocer, Kroger, in its Health & Wellness Specialty Pharmacy Retail Division. Prior to Kroger, she served as Chief Financial Officer for Northwestern Mutual’s Southeast region. “We’re incredibly grateful for Andy’s, Kelly’s, Crystal’s and Bob’s continued dedication to our business, and are excited to welcome Christy to our team, as we continue our mission of transforming Wealth distribution for our affiliated agents and advisors,” added Vietri. “The growth of our team is a testament to what we’re building here at AmeriLife, and I look forward to working with each of them in their new roles.” ### 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 more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served 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 +1 321-297-1112 jmaldonado@amerilife.com Partnership Inquiries Patrick Nichols +1 727-726-0726 pnichols@amerilife.com Company Website https://amerilife.com/

September 19, 2023 09:00 AM Eastern Daylight Time

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Genflow Biosciences CEO says human healthspan has not kept up with lifespan

Genflow Biosciences PLC

Genflow Biosciences PLC (LSE:GENF) CEO Dr. Eric Leire speaks to Thomas Warner from Proactive about the gene therapy company's work in the field of extending human longevity. He notes that the amazing advances made in advancing human lifespans over the last century have not been matched by a similar increase in people's healthspans, with many people spending the second half of their life plagued with various debilitating illnesses and conditions. "The purpose of our company is to increase the healthspan, that's the primary objective. If we can also increase the lifespan, fine... so we are a longevity company that's trying to extend healthspan and secondly maybe lifespan." The company's central asset is a centenarian version of the sirtuin six gene, which plays a crucial role in aging. They've identified a rare mutation of this gene found exclusively in centenarians, offering a promising avenue for intervention. Genflow's approach is supported by a strong team and close collaboration with a distinguished Scientific Advisory Board. He goes on to explain how Genflow Biosciences is going about its mission, revealing its most promising leads, before concluding by saying who else in the sector he admires. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 19, 2023 03:00 AM Eastern Daylight Time

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Avricore Health announces HealthTab now supporting first Rexall Pharmacy walk-in clinic

Avricore Health

Avricore Health CEO Hector Bremner joined Steve Darling from Proactive to share news regarding the company's flagship health-data management platform, HealthTab. The company has made a significant move by partnering with Rexall Pharmacy, one of Canada's largest pharmacy retailers, to integrate HealthTab into its walk-in clinic services. Bremner revealed that patients can now access testing through HealthTab at the first Rexall Pharmacy Walk-In Clinic located in Sherwood Park, Alberta. This collaboration enables HealthTab to offer both the Afinion 2™ blood-chemistry analyzer and the ID Now™ molecular platform by Abbott Rapid Diagnostics. This means that patients can receive rapid test results and immediate consultation with their pharmacist, facilitating timely healthcare interventions. HealthTab has played a crucial role in the last year by assisting pharmacists in screening patients for diabetes and cardiovascular conditions, as well as supporting those already diagnosed in better managing their health. With Rexall Pharmacy joining the HealthTab network, patients now have more accessible care options, empowering them to make meaningful and impactful changes to their health. This partnership underscores Avricore Health's commitment to leveraging technology to improve access to healthcare services, particularly within the pharmacy setting. The integration of HealthTab into Rexall Pharmacy's walk-in clinics not only enhances patient convenience but also contributes to early detection and management of health conditions, aligning with the broader goal of improving healthcare outcomes in Canada. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

September 18, 2023 02:03 PM Eastern Daylight Time

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Perimeter Medical Imaging new CEO makes key improvements in personnel and technology

Perimeter Medical Imaging AI

Perimeter Medical Imaging CEO Adrian Mendes joined Steve Darling from Proactive to discuss the strategic developments and innovations the company has undertaken since his appointment as CEO. Mendes highlighted several key initiatives aimed at driving Perimeter's growth and advancing its technology in the medical field. One notable addition to the team is Adam Hodges, a seasoned medtech sales executive with over 20 years of experience. Hodges has taken on the crucial role of overseeing the strategy and execution of sales-related goals, bringing valuable expertise to the company's efforts. Another significant advancement Mendes shared is the enhancement of Perimeter's AI capabilities. This involves leveraging additional training data and the latest AI advancements to improve the sensitivity, specificity, precision, and recall of their ImgAssist AI technology. This updated version is expected to significantly enhance the accuracy of image classification, reducing the incidence of false positives and negatives. Moreover, Mendes touched upon the positive interactions with the FDA in relation to the clinical development program for Perimeter's B-Series OCT medical imaging technology with ImgAssist AI. This collaborative engagement with regulatory authorities reflects the company's commitment to advancing its next-gen AI technology, ultimately aimed at improving clinical and economic outcomes in the field of breast surgical oncology. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

September 18, 2023 01:58 PM Eastern Daylight Time

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Futura Medical "on track for a profit in 2025" after strong first half

Futura Medical PLC

Futura Medical PLC (AIM:FUM, OTC:FAMDF) CEO James Barder speaks to Thomas Warner from Proactive London after the pharmaceutical company announced its interim results for the six months to 30 June 2023. Barder gives an overview of what he describes as a "pretty tremendous 2023 for Futura so far", highlighting the progress made in multiple markets with the company's topical erectile dysfunction treatment MED3000. He starts with a look at the enormously prospective US market where Futura secured both FDA approval for the product as well as a distribution deal with Haleon, who are responsible for the future launch and ongoing regulatory, development, marketing, and commercialisation of MED3000 in the USA. Barder also talks about the strides the company made in Europe during the first half and noted minimal complaints with over 200,000 packs sold. Financially, the company reported £1.7 million in revenue and a gross profit of £900,000, with Barder saying that he expects Futura to reach breakeven in 2024 and "is on track for a profit by 2025". Barder acknowledged the importance of production expansion to meet rising demand and highlighted efforts to strengthen distribution networks, particularly in Asia. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 18, 2023 11:20 AM Eastern Daylight Time

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