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Tiziana Life Sciences gets FDA green light to investigate potential Alzheimer's treatment

Tiziana Life Sciences PLC

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chief medical officer and chief operating officer Matthew Davis speaks to Thomas Warner from Proactive after announcing that Tiziana has received FDA clearance to investigate Foralumab as a potential treatment for Alzheimer's disease. Davis says that the news marks a significant milestone for both the company and for Alzheimer's treatment at large, going on to say that the drug will be assessed for efficacy in patients with existing FDA approvals and as a standalone therapy for mild to moderate Alzheimer's cases. The green light from the FDA comes after extensive groundwork, building on the success of Tiziana's work in multiple sclerosis. Davis highlights the wealth of patient safety data and preclinical evidence that bolstered the FDA's decision. Promising preclinical models indicated behavioural improvements in test animals. With the regulatory hurdle crossed, clinical trials are set to commence in collaboration with Brigham and Women's Hospital. Davis acknowledges the vast potential of the Alzheimer's market, which remains underserved. He emphasises the unique approach of Foralumab as the only fully human anti-CD3, which sets it apart from existing treatments. While precise timelines haven't been disclosed, Davis anticipates concrete developments within the next two quarters. He also assures audiences of Tiziana's continued commitment to multiple sclerosis research, with an investigator meeting and dosing of the first patient anticipated by year-end. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 09:28 AM Eastern Daylight Time

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Roquefort Therapeutics seeks to lock in future value with anti-cancer therapeutic patents

Roquefort Therapeutics PLC

Roquefort Therapeutics PLC (LSE:ROQ, OTCQB:ROQAF) chief executive Ajan Reginald speaks to Thomas Warner from Proactive after announcing the successful filing of a global patent for its anti-cancer therapeutics. Once approved, the international phase PCT (patent treaty cooperation) patent would cover the invention of Roquefort’s RNA oligonucleotide and mRNA therapeutics in over 155 countries, the company said in a statement. Reginald highlights the significant strides made recently by the likes of Moderna, BioNTech, and Merck in employing mRNA effectively against cancer. Roquefort's own promising results were unveiled in June, demonstrating what Reginald calls the cancer-killing potential of their mRNA and RNA oligonucleotide therapies for breast and liver cancers. The global patent covers their proprietary composition, securing their position in a competitive landscape. Reginald emphasises the importance of capturing value through patents, with a view to making the company's offerings enticing for potential partnerships or acquisitions. He explains that "by patenting [the treatments] we're making sure we own that future potential once its realised." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 09:03 AM Eastern Daylight Time

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MGC Pharmaceuticals to "move forward and speak to the FDA"

MGC Pharmaceuticals Ltd

MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) CEO and managing director Roby Zomer speaks to Thomas Warner from Proactive after the Europe-based plant-inspired medicine company announced the successful completion of a Pre-clinical Chronic Toxicology Evaluation of its immuno-modulation treatment CimetrA. The study was undertaken on 32 domestic swine, that received a study treatment (three dosages groups of CimetrA® and Placebo) for 14 days. Zomer describes the positive results from the trial as the "final piece of the puzzle" and says that MGC can now "move forward and speak to the FDA" about getting the treatment approved. The CEO expresses optimism that the alignment of safety and efficacy results will facilitate a smooth interaction with the FDA and says he hopes to file in early 2024. Zomer says that the results from the trial mean that "we have a quite straightforward line to speak to the FDA, and take [CimetrA] to the big league and get it approved in America. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 03:37 AM Eastern Daylight Time

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A Leap in Ionization Prediction: ACD/Labs Unveils Groundbreaking Version of Modeling Software at ACS Fall 2023

ACD/Labs

Version 2023 of the Classic pK a calculator in Percepta® includes a significantly expanded training set for improved prediction accuracy, broader chemical applicability; and algorithmic changes that deliver impressive speed enhancements to this industry-leading software. 26 years after the release of their first ionization predictor, ACD/Labs, an informatics company that develops and commercializes software in support of R&D, today announces the release of their latest version of molecular property calculators on the Percepta Platform. Andrew Anderson, Vice President of Innovation and Informatics Strategy at ACD/Labs says, “Metaphorically speaking, data is the 'heartbeat' of chemistry R&D, generated during either physical experimentation or in silico calculation. In an age where research groups are looking to harness the power of data in artificial intelligence and machine learning frameworks, prediction reliability is one of the most important success determinants. Our new version of Percepta pK a exemplifies our commitment to enabling reliable, data-driven R&D. Many molecules under investigation in R&D labs are susceptible to ionization. Knowing 'when and where' is of paramount importance since the same chemical might behave differently under different conditions. Reliable and accurate predictions not only help computational scientists develop accurate SAR models; these predictions also help scientists account for the ionization properties of molecules during their 'design, make, test' cycles. Finally, accurate descriptor prediction will empower data scientists with reliable insights for the 'next crop' of ground-breaking innovation activity. We're proud to support our large user community with this important new release.” Ionization—frequently expressed as the acid dissociation constant for molecules with ionizable centers, or pK a —is a fundamental property that affects the behavior of chemical compounds in environmental, pharmaceutical, agrochemical, and other fields. It plays a crucial role in defining other properties like lipophilicity (log D ), aqueous solubility, toxicity (hERG), and helps with understanding the chemical reactivity of molecular entities. In biopharma, it is used to model more complex ADME behaviors such as absorption, bioavailability, and clearance, and to develop delivery systems and formulations for new drug entities. pK a values are used by researchers to understand and modulate the behavior of molecules in biological and environmental systems, and to successfully apply separation technology such as chromatography. Furthermore, predictive software is an integral part of green chemistry initiatives and sustainable practices, providing a reliable alternative to physical experiments. “This new release is a shining example of our continued commitment to excellence,” said Andrius Sazonovas, Head of Percepta Software Development at ACD/Labs. “Since the introduction of our first ionization predictor in 1997; my colleagues and I have overseen the improvements to our computational software and have worked on numerous customer projects to apply our modeling methodology to proprietary datasets at innovative chemistry-driven organizations. In our tests of Percepta version 2023, we saw a 5–10 fold increase in the speed of calculation of pK a for various datasets. Significant improvement was also observed for prediction accuracy. While this varies for different datasets, 120% improvement was noted for a set of ~370 novel pharmaceutical compounds with ~600 pK a values in a recent collaborative project. This release truly represents the next generation of pK a prediction from ACD/Labs, with respect to performance, reliability, and speed.” For more information about in silico predictions available from ACD/Labs, meet our team at Booth 933 in the ACS exhibition hall or visit acdlabs.com/percepta. ACD/Labs is a leading provider of scientific software for R&D. We help customers in >94 countries around the world assemble digitized analytical, structural, and molecular information for effective decision-making, problem solving, and product lifecycle control. Our enterprise technologies enable automation of molecular characterization and facilitate chemically intelligent knowledge management. ACD/Labs provides worldwide sales and support and brings decades of experience and success helping organizations innovate and create efficiencies in their workflows. For more information, please visit www.acdlabs.com. Follow us on Twitter and LinkedIn. Contact Details ACD/Labs Sanji Bhal +1 416-368-3435 media@acdlabs.com Racepoint Global Allison Matthews +1 617-624-3248 amatthews@racepointglobal.com Company Website https://www.acdlabs.com/

August 14, 2023 12:00 PM Eastern Daylight Time

Experts encourage including HPV vaccine in back-to-school preparation for kids

YourUpdateTV

Every year, nearly than 40,000 men and women are diagnosed with a cancer caused by human papillomavirus (HPV) and about 14 million people, including teens, become infected with HPV each year. Recently, Heather Brandt, PhD, the Director of the HPV Cancer Prevention Program at St. Jude Children’s Research Hospital, conducted a satellite media tour to increase awareness and education about the importance of HPV vaccination in preventing HPV-related cancers. Dr. Brandt is urging parents and caregivers to include HPV vaccination in their child’s back-to-school immunizations. A video accompanying this announcement is available at: https://youtu.be/36xZsO3L3U4 There are several good reasons to immunize children against HPV as early as possible. HPV vaccination is recommended for males and females ages 9-26. HPV vaccination is encouraged to be completed by the 13th birthday, well before the potential for exposure to HPV, which is why Dr. Brandt is encouraging including HPV vaccination as part of a child’s back-to-school preparation. HPV can cause six different types of cancers: cervical, vaginal, vulvar, oral, anal and penile. One of the biggest misconceptions is that HPV only affects women, which is false. Men can also be diagnosed with HPV and carry the virus, which is why HPV vaccination is encouraged for both females and males. It is important that parents know which vaccines are recommended for their children and why. This allows for parents to have a thorough discussion with their child's health care provider and can avoid surprises and last-minute decision-making on vaccines. For more information go to stjude.org/hpv. ------------------------------------------------------------------------- BIO: Heather M. Brandt, PhD, is the Director of the HPV Cancer Prevention Program at St. Jude Children’s Research Hospital. Dr. Brandt, a social and behavioral scientist, focuses on working with stakeholders to prevent and control cancer by using evidence-based interventions through innovative, partnered approaches. About the HPV Cancer Prevention Program Launched in 2021, the HPV Cancer Prevention Program at St. Jude Children’s Research Hospital has set out to increase awareness and education about the importance of HPV vaccination in preventing HPV-related cancers. As the only NCI-designated Comprehensive Cancer Center dedicated solely to children, St. Jude Children’s Research Hospital has an important role and responsibility in increasing HPV vaccination rates locally, regionally, and nationally. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

August 14, 2023 11:13 AM Eastern Daylight Time

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Kuros Biosciences "doing extremely well" in innovative spinal fusion treatments

Kuros Biosciences

Kuros Biosciences (SIX:KURN) CEO Joost de Bruijn speaks to Thomas Warner from Proactive about the innovative work the spinal fusion biologics-focused company has been focused on recently and looks ahead to what investors can expect from it in the future. Kuros Biosciences is headquartered in Switzerland with locations across the Netherlands and the USA, and specialises in autologous biologics aimed at regenerating bone tissue, with a specific focus on spinal fusions. Its flagship and first commercial product MagnetOs, is a unique synthetic bone graft that de Bruijn explains stands out for its unique surface topography that stimulates bone formation post-implantation, thereby setting it apart from other synthetic alternatives. De Bruijn also a product still in development called Fibrin PTH, a pharma-derived treatment designed to stimulate bone formation through gradual release of parathyroid hormone, offering a novel approach to addressing spinal issues and potential opening up a lucrative new market. He goes on to give a summary of the company's half-year results highlighting strong revenue growth in the US and reveals an ambitious five-year growth target. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 11, 2023 11:34 AM Eastern Daylight Time

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News Release

NuggMD Celebrates Launching Services in 23rd State, Washington

NuggMD

NuggMD, the nation's leading medical marijuana telemedicine platform, has launched its service in Washington state for just $139. Since its founding in 2015, NuggMD has connected over 1,000,000 patients to their medical marijuana physicians via its state-of-the-art telehealth platform. "Telehealth has never been more important for patients who are increasingly feeling the pinch of inflation, especially on the West Coast," said Alex Milligan, NuggMD co-founder and CMO. "We're excited to offer our platform to physicians who wish to provide follow-up care to their patients in Washington state, where appropriate." Washington's registered patient population has fallen to nearly half of its peak of over 20,000 registered patients in 2017, with only 6,315 cards issued so far in 2023. Registration with the state is voluntary, but only registered patients are exempt from cannabis retail taxes. "Sure, there are fewer patients now," said Collin Mann, CEO and NuggMD co-founder. "But Washington's medical program is still very important for both registered and unregistered patients. We hope we can help keep that program alive by helping patients more easily access their physicians." NuggMD's platform is available from 8 am to 10 pm seven days a week. No appointment is needed, and patients who don't qualify for their state's medical cannabis program won't be charged for their evaluation. About NuggMD NuggMD is the nation's largest medical marijuana technology platform, serving patients in California, Connecticut, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nevada, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, and West Virginia. They've connected over 1,000,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit NuggMD.com/Washington. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

August 10, 2023 05:31 PM Eastern Daylight Time

Context Therapeutics CEO Marty Lehr notes progress towards the clinic with CTIM-76 in 2Q update

Context Therapeutics

Context Therapeutics (NASDAQ:CNTX) CEO Marty Lehr takes Proactive's Stephen Gunnion through progress with the company's lead program, CTIM-76. Lehr explained that CTIM-76 is a T cell engaging bispecific antibody targeting Claudin 6 (CLDN6) on tumor cells and CD3 on immune cells. The program is on track for an Investigational New Drug Application (IND) filing in the first quarter of 2024, Lehr added. The company has provided consistent cash guidance to late 2024, which it believes provides adequate capitalization through its next major inflection point. An upcoming preclinical update is anticipated in the second half of 2023 with further information on CTIM-76, relating to its preclinical development, specifically its in vivo efficacy, safety, and tolerability. Lehr also shared Context Therapeutics' focus on manufacturing and safety studies as they move towards the IND filing. He noted that other competitors, including private company TORL Biotherapeutics and BioNTech, which is publicly traded, are planning updates on Claudin 6 before the end of 2023. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 10, 2023 02:19 PM Eastern Daylight Time

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News Release

Xeris Biopharma CEO unveils record quarterly revenue, underpinned by unique business model

Xeris Biopharma Holdings

Xeris Biopharma chairman and CEO Paul Edick joined Proactive's Stephen Gunnion with details of the company's second-quarter performance, which saw record revenue driven by the success of their products, including Gvoke, Keveyis, and Recorlev. For the quarter, which ended on June 30, 2023, the company achieved sales of $38 million, up 50% year-over-year and 14% sequentially. Edick noted that Xeris' unique business model includes three pillars: a thriving commercial business, technology for in-house product development, and partnerships to enhance others' drugs. This diversified approach provides the company with strategic flexibility and options for growth. He also expressed confidence in achieving cash flow breakeven by the fourth quarter and emphasized the company's sustainability without the need for additional public equity sales. Regarding the pipeline program for Xerisol levothyroxine, Edick said Xeris is enrolling in the phase two study. The data collected will shape the phase three trial and regulatory negotiations with the US Food and Drug Administration (FDA). Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 10, 2023 11:59 AM Eastern Daylight Time

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