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hVIVO secures fresh contract to round out "wonderful" year

hVIVO PLC

hVIVO PLC (AIM:HVO) chief executive Mo Khan speaks to Thomas Warner from Proactive after the specialist contract research organisation announced it has signed a £16.8mln full-service human challenge contract with a top-five global pharmaceutical company. Khan explains that the contract focuses on a respiratory syncytial virus (RSV) strain. The project includes manufacturing and dosing steps, aiming to confirm the infectivity rate. He says the majority of the revenue from this project will be recognised in 2024 and 2025. Kahn highlights the significance of RSV in hVIVO's growth as a Contract Research Organization (CRO). He noted that their work with this strain has aided clients in achieving Fast Track designation and, in one instance, marketing authorisation for an RSV vaccine. This contract marks a shift in clinical trial approaches, moving from traditional drug versus placebo trials to multi-cohort trials. This innovative approach allows for the examination of drug efficacy at various doses and the implementation of triggered dosing, which mimics real-world treatment scenarios. Finally, Kahn shared positive financial news, stating that hVIVO is trading ahead of expectations for what he describes as a "wonderful" year, with EBITDA margins surpassing 20%, exceeding previously published guidance. A comprehensive update is expected in January of the next year. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

December 13, 2023 04:46 AM Eastern Standard Time

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News Release

ProSomnus CEO Len Liptak unveils game-changing device and promising clinical trial results for 2024

ProSomnus

ProSomnus Inc CEO Len Liptak joined Steve Darling from Proactive to discuss the company's groundbreaking intramural mouth guard, which has received FDA clearance as a medical device for the treatment of obstructive sleep apnea and snoring. The ProSomnus device effectively positions the jaw forward during sleep, preventing airway collapse and addressing sleep apnea issues. Liptak emphasized the significance of the FDA clearance, which allows for insurance reimbursement and categorizes the ProSomnus device as a therapeutic solution for sleep apnea and snoring. The company is strategically targeting the substantial market of individuals who discontinue the use of CPAP (Continuous Positive Airway Pressure) machines, estimated at 3 to 4 million people annually. In light of the recent Philips CPAP recall, ProSomnus is positioning itself as a leading alternative to CPAP treatment for obstructive sleep apnea. The company has a strong foundation of scientific data supporting the efficacy of its device. Financially, ProSomnus has reported record revenues and a remarkable 46% year-to-date growth, demonstrating its commitment to cost reduction and maintaining a robust bottom line. Looking ahead to 2024, ProSomnus has ambitious plans for continued growth. These initiatives include FDA filings to expand labeling for the device and the development of a next-generation device featuring an oxygen sensor for real-time patient monitoring. The company prioritizes personalized manufacturing to ensure optimal treatment effectiveness and has achieved promising results in clinical trials, with a manuscript set for release in 2024. In summary, ProSomnus is dedicated to making sleep apnea treatment more accessible and technologically advanced, offering an innovative solution to improve the lives of those affected by sleep apnea and snoring. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

December 12, 2023 02:17 PM Eastern Standard Time

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Tonix Pharmaceuticals shared details of IND clearance for Phase 2 trial of TNX-2900

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to delve into the significant development involving the US Food and Drug Administration (FDA)'s clearance of the Investigational New Drug (IND) application for TNX-2900. This innovative drug represents a proprietary magnesium-enhanced formulation of intranasal oxytocin, designed to address Prader-Willi syndrome (PWS) in children and adolescents. Dr Lederman was quick to highlight the importance of this milestone, noting that TNX-2900 had already been granted Orphan Drug designation by the FDA back in 2022. The IND clearance paves the way for a crucial Phase 2 study, aimed at determining the optimal dosage for TNX-2900 in treating PWS. This study will involve approximately 36 PWS patients, thoughtfully divided into four distinct groups, each comprising around nine patients. Within these groups, one will receive a placebo, while the remaining three will be administered varying dosage regimens of TNX-2900. Tonix Pharmaceuticals' strategic plan includes the intention to collaborate with a partner to further advance TNX-2900 through its clinical development for PWS. This collaborative effort underscores the commitment to addressing a pressing medical need, as PWS stands out as the most common genetic cause of life-threatening childhood obesity. Importantly, PWS affects both males and females equally, spanning all races and ethnicities. This complex syndrome arises due to the absence of expression of specific genes located on the paternally acquired chromosome 15. In essence, this groundbreaking development in the treatment of Prader-Willi syndrome represents a significant step forward in the pursuit of better outcomes for children and adolescents grappling with this challenging condition, demonstrating Tonix Pharmaceuticals' dedication to advancing medical science and improving the lives of those affected by rare diseases. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

December 12, 2023 01:40 PM Eastern Standard Time

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Professor David Nutt presents his insights into psychedelic medicine - Neural Therapeutics

Neural Therapeutics Inc.

Neural Therapeutics Scientific Advisory Board Member Professor David Nutt presents fascinating insights into psychedelic medicine and its potential uses. His pioneering research, influencing Australia's adoption of psychedelic medicines, underscores a pivotal moment in mental health care. Nutt highlighted the historical journey of psychedelics, from widespread research in the 1950s and 60s to their banning due to misperceptions about safety and efficacy. This ban, tied to political motives, stifled research for decades. Recent studies, however, have rekindled interest, demonstrating the low harm and high efficacy of psychedelics compared to other substances, particularly in clinical settings. Professor Nutt's work reveals significant breakthroughs in treating conditions like treatment-resistant depression, addiction, and alcoholism using psychedelics like psilocybin and mescaline. His team's studies show unprecedented success rates, often with just a single dose, offering hope for those with chronic mental health issues. These findings are supported by neuroimaging studies that illustrate how psychedelics promote neuroplasticity, enabling the brain to forge new, healthier thought patterns. This revival of psychedelic research marks a revolution in mental health treatment, offering new pathways for those who have not benefited from traditional therapies. The Australian regulatory body's recent approval of psilocybin for treatment-resistant depression exemplifies this shift. Nutt's presentation, a blend of historical context, scientific evidence, and a call for compassionate use, heralds a new era in mental health care, emphasizing the potential of psychedelics to transform lives. For further reading, Nutt recommends his co-edited book on psychedelics in psychiatry and a forthcoming book for the general public. The presentation is introduced by Neural Therapeutics CEO and Director Ian Campbell. Neural Therapeutics is a drug-discovery company focusing on plant-based active substances with the goal of delivering beneficial, over-the-counter dietary supplements and psychedelic-based therapeutic medicines to treat serious mental ailments where no significant treatment is available today. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

December 12, 2023 10:22 AM Eastern Standard Time

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New Report Highlights Weight Stigma in Media and Calls for Change

Media Empathy Foundation

A new national survey conducted for the Media Empathy Foundation sheds light on pervasive weight stigma in media, revealing that individuals with higher body weight perceive negative stereotypes, body shaming, weight blaming and exclusion from leading roles in TV and other forms of media. The report, titled “Weight Stigma and Media: Assessing the Impact”, draws attention to harmful impact and emphasizes the need for more inclusive and respectful representations across all channels. The study surveyed more than 1,200 U.S. adults with a Body Mass Index (BMI) of 30 or higher, a demographic that accounts for 42% of American adults within the range of obesity according to the U.S. Centers for Disease Control and Prevention. The findings reveal a concerning pattern of problematic media portrayals with potentially detrimental consequences and underscores the need for consistent, compassionate, and accurate representation of individuals with higher body weight in media. The findings were discussed by a panel of leaders in media (Deborah Roberts, Al Roker and David Sloan) and academia (Rebecca Puhl, PhD and Holly Lofton, MD) at the Edge in NYC. “Weight stigma in the media exists in both blatant and subtle ways, reinforcing harmful attitudes and societal weight bias of people with higher body weight. There is a clear need for more respectful and compassionate media portrayals of people of diverse body sizes,” said Rebecca Puhl, PhD, Deputy Director for the Rudd Center for Food Policy & Health and Professor in the Department of Human Development and Family Sciences at the University of Connecticut. Key findings from the report include: High Prevalence: Most respondents assert that social media (73%), TV shows and movies (65%) and TV news (55%) often or sometimes perpetuate negative stereotypes about individuals with higher body weight. Only a small minority (5% or less) feel that this never happens. Health News Stereotyping: Respondents say that health news reports tend to blame people for their weight (70%) and suggest that all people with higher body weight are unhealthy (79%). Terminology Matters: A notable 88% of those surveyed find the term “fat” to be offensive or inappropriate, more so than “morbidly obese”, while “plus-size” and “overweight” are seen as appropriate by more than half. Negative Personal Impact: One in three respondents report that media portrayals have made them feel disrespected, with about as many reporting negative effects on their body image and self-esteem. One in four report negative effects on their mental health. Desired Change: Respondents are calling on creators to focus on character attributes beyond body type and to eliminate weight-based stereotypes, humor, or derogatory portrayals, advocating for more inclusive roles and realistic character development, as well as emphasizing health and wellness without resorting to shaming. Holly Lofton, MD, Clinical Associate Professor of Medicine and Surgery and Director of the Medical Weight Management Program at NYU Langone Health added, “It’s important that health news media more consistently report on the complex causes of obesity rather than assuming it’s the result of poor willpower or self-discipline.” “The media industry shapes the way we think and has the power to create a more aware and supportive culture for people with higher body weight,” said Helene Ellison, Founder and President of the Media Empathy Foundation. “That’s our hope in bringing weight stigma to the forefront.” The report was produced for the Media Empathy Foundation by Langer Research Associates and was made possible thanks to the support of Novo Nordisk Inc. For more information on the Media Empathy Foundation and to access the full survey findings, please visit: https://www.mediaempathy.org/. For more information on obesity, visit the Obesity Action Coalition at: https://www.obesityaction.org/. For PR Inquiries and more information on the upcoming panel discussion, contact: Kristen Long Communications, Kristen@kristenlongcommunications.com About the Media Empathy Foundation: The Media Empathy Foundation is a 501(c)(3) nonprofit organization that was founded with the mission to reduce health stigma by promoting empathy, compassion, and inclusivity in all forms of media. Contact Details Media Empathy Foundation Helene Ellison info@mediaempathy.org Company Website https://www.mediaempathy.org/

December 12, 2023 09:04 AM Eastern Standard Time

Investing in the U.S. Health Care Sector with the Health Care Select Sector SPDR Fund (XLV)

Select Sector SPDR

The health care industry is an ever-present sector in the investment landscape, offering steady growth and resilience even during challenging times, thanks to factors like aging demographics, which drive the performance of companies in this sector. For investors looking to gain exposure to this robust market, the Health Care Select Sector SPDR Fund ( XLV ) presents a cost-effective and efficient option. XLV provides broad exposure to core companies within the U.S. health care industry by tracking health care stocks from the S&P 500 Index, weighted by market cap. Top holdings* include UnitedHealth Group (10.54%), Lilly (9.70%), Johnson & Johnson (7.66%), Merck (5.35%), AbbVie (5.17%), and Thermo Fisher (3.94%), representing more than 40% of the fund. About the Health Care Select Sector SPDR Fund (XLV) Launched in 1998, XLV is the oldest health care ETF in the market. With over $37 billion in assets under management and a low total expense ratio of 0.10%**, this fund offers easy access to major players in the pharmaceuticals, health care equipment and supplies, health care providers and services, biotechnology, life sciences tools and services, and health care technology industries. The health care industry is one of the largest in the U.S. economy, with demand remaining consistent due to the essential nature of its services. This ETF capitalizes on that demand, providing focused exposure to leading health care names. XLV has proven to be a useful tool for investors seeking strategic or tactical positions in the health care sector. Moreover, the transparency of XLV is one of its main advantages. Investors can follow daily portfolio holdings and weightings at sectorspdrs.com, ensuring they are always informed about their investments. As consumer spending on health care continues to rise year over year, XLV represents a valuable opportunity to capture this steady growth. The Health Care Select Sector SPDR Fund ( XLV ) allows easy access to the largest companies in the health care industry. As an investment vehicle, it offers a diversified methodology that can fit portfolios and investment strategies in a broad market manner, making it a practical tool for investors of all sizes. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. *Holdings, Weightings & Assets as of 11/30/23 subject to change **Ordinary brokerage fees apply DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007096 EXP 1/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

December 12, 2023 07:00 AM Eastern Standard Time

Contract Management Institute Announces New Governance Board

National Contract Management Association

National Contract Management Association’s (NCMA) Contract Management Institute (CMI), an institution dedicated to advancing the profession of contract management is thrilled to introduce its newly appointed Governance Board for the 2023-2024 term. These accomplished professionals will play a pivotal role in guiding the strategic direction of CMI and ensuring the organization's success. "Having had the privilege of working alongside these distinguished professionals throughout my career, I am absolutely thrilled and deeply proud to welcome them to the newly revitalized CMI," stated CMI's Executive Director and former Department of Homeland Security Chief Procurement Officer, Soraya Correa. "Their exceptional expertise and dedication will undoubtedly contribute to our shared vision, and I look forward to the extraordinary journey ahead." NCMA Chief Executive Officer, Kraig Conrad will become the Board Chair for CMI. He expressed his excitement, saying, "I am delighted and honored to serve as Chair for the Institute. CMI is poised to become an important extension of NCMA, providing valuable resources to elevate our profession. I look forward to our journey together and the positive impact we will make." Denyce Carter, the current Board Chair of NCMA, will be joining Kraig Conrad as a distinguished addition and Vice Chair to the CMI board. She said, "I look forward to being part of an initiative that identifies and creates ways to enhance contract management practices, ultimately improving the profession for the workforce and the broader acquisition community." Along with Mr. Conrad and Ms. Carter, the Governance Board includes several accomplished professionals – including three NCMA past Presidents – that bring a wealth of knowledge and experience to the CMI board, representing a diverse range of organizations from government agencies and industry leaders to top consulting firms. The full list includes: Amanda Christian, Senior Vice President of Subcontracts and Procurement at CACI International Inc. She is responsible for setting direction, policy, and procedures based upon corporate-level strategy, and ensuring that procurement and subcontracts personnel provide value and contribute to the overall success of the company. Amanda is a Past-President of NCMA and served on its Board of Directors for seven years. She is a Fellow and currently serves on the Board of Advisors. Alan Chvotkin, Partner at Centre Law Group where he specializes in federal government contracts law and its policies and practices, including counseling companies on a wide range of matters from contract formation and performance through disputes and claims. Mr. Chvotkin is a Fellow of NCMA and currently serves on its Board of Advisors. Kim Denver, Senior Vice President and Chief Contracts Executive at Leidos, leads a team of over 250 contracts professionals, overseeing a diverse portfolio of thousands of active contracts, and previously held a key role as Deputy Assistant Secretary of the Army for Procurement. Mr. Denver currently serves on NCMA’s Board of Advisors. Wendy Masiello is currently an independent consultant, having retired from the U.S. Air Force as a three-star general in July 2017. During her 36-year career with the Air Force, she served as director of the Defense Contract Management Agency; deputy assistant secretary (contracting), Office of the Assistant Secretary of the Air Force for Acquisition; and program executive officer for the Air Force’s $30 billion service acquisition portfolio. She is an NCMA Past-President, and currently a member of the Board of Directors for KBR Inc. and Board of Advisors for NCMA and the Public Spend Forum Debra Scheider is Vice President, Corporate Contracts for Lockheed Martin Corporation. She is responsible for leading the Corporations Contracting, Industrial Development, and Estimating work encompassing policies, strategies, training, and procedures across the Corporation. Ms. Scheider is Past-President of NCMA and served on its Board of Directors for nine years. She is a Fellow of NCMA and currently serves on the Board of Advisors. She is a Director for the Procurement Round Table. Karla Smith Jackson, currently serving as the Senior Procurement Executive, Deputy Chief Acquisition Officer, and Assistant Administrator for Procurement at NASA, is a seasoned professional with extensive expertise with more than three decades of federal contracting experience. Her noteworthy background is in program management, acquisition, and contract planning. She is currently a member of the NCMA Board of Directors. Charlie Williams, President, CWilliams, LLC., held a number of pivotal roles that significantly contributed to the field of contract management., Notably, he served as the Deputy Assistant Secretary, Contracting for the United States Air Force, Director of the Defense Contract Management Agency (DCMA), Commissioner on the Section 809 Panel, President of the NCMA Board of Directors, Chair of the NCMA Standards Consensus Body, a valued member of the NCMA Board of Advisors, and a distinguished Member of the NASA Advisory Council. CMI is dedicated to fostering excellence in contract management by conducting research, studies, and analyses that promote engagement, standards, professional development, and enhanced business practices. The new Governance Board will play a pivotal role in guiding the organization's strategic direction and ensuring the continued growth and success of CMI. For more information about the Institute and its Governance Board, please visit ncmahq.org/cmi. The National Contract Management Association (NCMA) – www.ncmahq.org – stands as the premier contract management organization whose mission is to collaborate towards a globally recognized contract management profession that strengthens its nexus with related acquisition communities. Serving approximately 20,000 members in both the public and private sectors, NCMA propels the growth, advancement, and impact of practitioners through a steadfast commitment to serve through the open exchange of ideas in neutral forums. Contact Details National Contract Management Association Holly DeHesa +1 281-865-3296 holly.dehesa@ncmahq.org Company Website https://www.ncmahq.org

December 12, 2023 05:00 AM Eastern Standard Time

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USA Benefits Group Partners with AmeriLife to Expand Agent Opportunities & Serve More Clients

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, announced today that it has partnered with USA Benefits Group, a fast-growing, national health brokerage dedicated to delivering the highest quality products, service, and support to independent agencies, agents, and their clients. Per the agreement, terms of the deal were not disclosed. “We see this partnership as a power play to further USA Benefits Group's explosive growth,” said Rick Banville, CEO of USA Benefits Group. “AmeriLife is a rapidly expanding giant in the industry who takes the pressure off of agencies like ours through resources like HR, payroll, compliance, legal, marketing, recruiting, and technology so we can do what we do best: recruit and train agents and agencies to be successful. We are very excited about our bright future together.” “We are so grateful and honored to become partners with AmeriLife,” added Jessica Banville, president of USA Benefits Group. “We are thrilled that our agents and clients will benefit from an even larger portfolio of products and support. This partnership will give us even greater opportunity in making the industry better as we continue to develop training systems that bring success to all. We are stronger together!” For more than three decades, USA Benefits Group has been at the forefront of helping agents and their clients navigate the complexities of health and ancillary insurance (including ACA and ACA alternatives) for the under-65 market. Over the years, the company has expanded its portfolio to include Medicare Advantage and Medicare Supplement insurance, life insurance, and health insurance benefits for small businesses, as well as developed proprietary tools and training for its insurance professionals to succeed and thrive. Headquartered in nearby Spring Hill, Fla., USA Benefits Group boasts nearly 2,000 independent contracted agents nationwide. Now, with access to AmeriLife’s best-in-class resources, deep product portfolio, and industry expertise and leadership, USA Benefits Group is primed to supercharge its growth and deliver even more value to beneficiaries across the United States. “I’m excited to welcome Rick, Jessica and the USA Benefits Group family to ours,” said Scotty Elliott, Chief Distribution Officer for AmeriLife Health. “Our shared values and commitment to excellence in service makes this a winning partnership right out of the gate, and I can’t wait to see what we can accomplish together.” ### About USA Benefits Group USA Benefits Group is a nationwide insurance agency dedicated to the principles of service, integrity, professionalism and diversity. The company provides an extensive range of insurance products and pledges to honor its commitment to its producers, clients and carriers by holding itself to the highest ethical standards. Everything that USA Benefits Group does is designed to ensure that its customers are presented quality products with a “Servant’s Heart” and a goal of exceeding expectations. For more information, visit USABG.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 a 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/

December 11, 2023 10:10 AM Eastern Standard Time

Faron Pharmaceuticals presents "very positive" Phase 1 data at ASH Conference

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) chief executive Dr Markku Jalkanen speaks to Thomas Warner from Proactive London after the clinical stage biopharmaceutical company announced "very positive" Phase 1 data from the ongoing BEXMAB study in myeloid malignancies. The data is being presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place until tomorrow, December 12, 2023, in San Diego, California, and virtually. Jalkanen says the data reveals a promising response in patients, especially in inducing myeloid differentiation in Myelodysplastic Syndrome (MDS), a condition with limited treatment options Typically, patients with this type of cancer have a life expectancy of around 24 months, making these results particularly significant. Investors and shareholders have responded positively to this latest news, as the trial shows a response rate potentially 5 to 10 times higher than the current standard of care. Faron Pharmaceuticals is now preparing to advance to the next trial phases and is exploring potential partnerships. Regarding the company's overall performance in 2023, Dr. Jalkanen expresses satisfaction with Faron's ability to maintain and even increase its pace, with promising data accumulating from ongoing trials and the initiation of new ones. The company is targeting a marketing approval application by 2025, staying on track with its previously set goals. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

December 11, 2023 10:09 AM Eastern Standard Time

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