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hVIVO CEO reports on "very strong" H1 2023

hVIVO PLC

hVIVO PLC (AIM:HVO) chief executive Mo Khan speaks to Thomas Warner from Proactive after the specialist contract research organisation released a trading update for first half of 2023 - a period he describes as a "very strong six months." Khan gives his highlights from the update, highlighting a 52% year-on-year increase in revenues to £27.3mln. He attributes the growth to improved operational efficiencies and the increasing frequency of large concurrent trials. The company reports cash reserves of £31.3 million, even after paying out a special dividend of £3 million, with an order book of £78 million. Addressing a technical detail, Khan mentioned that the company would now report revenue exclusive of other income to align with industry practice. Despite delays at the Medicines and Healthcare Products Regulatory Agency impacting some UK clinical trials, Khan says that hVIVO has successfully managed the situation through its risk mitigation strategy. For the next six months, hVIVO plans to maintain its growth momentum, with full-year guidance of £53 million in revenue and an ever-expanding order book. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 27, 2023 08:36 AM Eastern Daylight Time

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Powering Multiple CPG Industries With A 'Secret Sauce': Bioscience Company Reports Its Proprietary Nanotech Improves Taste And Absorption Of Functional Foods & Beverages

Rexis Biotech

By Rachael Green, Benzinga This month, Rexis Biotech, the company behind an innovative new nano fiber technology for creating highly water-soluble infusions from hydrophobic molecules, announced a new partnership with 3Chi, Inc. The partnership makes Rexis the world’s largest hemp-derived cannabis manufacturer and will see 3Chi’s initial order of 1M cans distributed via Rexis’ massive national distribution network. The agreement is the latest in a string of major contracts Rexis has landed this year, and the news comes in the midst of the biotech’s ongoing crowdfunding campaign through WeFunder, where Rexis is seeking to raise equity and awareness of its new technology. Rexis Is Leveraging Its Proprietary Fused Polymorph Nano Fiber Technology To Improve The Quality And Potency Of Consumer Goods Rexis uses a proprietary co-crystal in a patented procedure that creates a completely tasteless and odorless powder for infusing into foods and beverages. Co-crystallization combines two or more molecules into a single stable crystal structure. It’s already being used in the pharmaceutical industry to improve the bioavailability of drugs. But it’s typically been limited to small-scale or specialized production because it’s a complex and expensive process. Trademarked under the name Fused Polymorph Nano Fiber Technology, this advanced co-crystallization platform turns hydrophobic molecules like CBD, THC and many essential vitamins into nanoparticles ranging from 35 to 50 nanometers. For scale, a single viral cell is about 50 to 100 nanometers. This tiny size makes the ingredients easier for the human body to absorb because it is mostly absorbed within the mouth, well before first past digestion. Clinical research has found that CBD processed using Fused Polymorph Nano Fiber Technology TM is more than 48% bioavailable, for example. That’s a substantial improvement over the 6% bioavailability of standard CBD oil. Better bioavailability means more of the active ingredient is actually getting absorbed into the bloodstream. For ingredients like CBD or THC, that can mean a faster onset of effects and the ability to get the effects you need with a lower dose. Rexis says its proprietary nano fibers can be absorbed into the bloodstream more quickly and completely than standard emulsions. They can even adjust the length of the fibers to speed up or slow down the onset/offset timing. CBD oil isn’t the only poorly-absorbed ingredient on the market. Many of the most popular supplements contain hydrophobic vitamins like Vitamin A, C, D, E, and K. Other functional ingredients like caffeine and many of the essential amino acids the body needs to make protein are also hydrophobic. In addition to being poorly absorbed, the amount that actually makes it into the bloodstream can vary depending on a range of factors. That means you can take the exact same dose and get different results. The technology Rexis uses is meant to not only improve those absorption rates but also make them more consistent so that consumers can more reliably predict what dose to take to meet their needs while ensuring taste is retained or improved – this gives the company a potentially large total addressable market spread across multiple industries. Rexis Is Gaining The Attention Of Industry Leaders Across Key Markets Manufacturers are already hopping on board to use this Fused Polymorph Nano Fiber Technology TM in their supplements, beverages, and other consumer products. Rexis says it’s already signed more than $8.35 million worth of contracts in the first half of this year with a range of clients in rapidly growing industries like cannabis, wellness and functional beverages – the company boasts of powering brands like 3Chi and First Person Group thanks to its focus on retaining or improving taste. In addition to the million dollar agreement with 3Chi this month, the company has signed contracts with other cannabis leaders like Happy Valley, Redbud Roots and Nectr. But it’s not just licensing its tech to customers. Rexis is also developing its own line of retail brands and pharmaceuticals to add additional revenue streams and showcase the wide-ranging potential of this technology. Meanwhile, investors have already helped the biotech raise over $260K through its crowdfunding campaign. For investors interested in learning more, check out their WeFunder page. Rexis is the industry leader and pioneer in developing Hydrophobic Molecule Delivery systems. Leading in the innovation, production and formulation of water based ingredients for use in the Pharmaceutical and Consumer Packaged goods industry. Established in 2022, Rexis is building a core mix of proprietary IP used to sustain strong sales models with pharmaceutical licensees, consumer packaged goods manufacturers and clinical research teams. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Ryan Erving ryan@rexissystems.com Company Website https://www.rexissystems.com

July 26, 2023 09:25 AM Eastern Daylight Time

AMA Issues Details On First Psychedelics Therapy CPT Code – Thanks To These Psychedelic-Focused Mental Healthcare Companies

COMPASS Pathways

By Rachael Green, Benzinga The American Medical Association’s (AMA) Panel recently released the full details of a new code for psychological support during the administration of psychedelic treatments. Slated to take effect starting in 2024, the new temporary CPT III code marks an important step toward broader access to the novel treatments as it gives healthcare providers a way to code and seek reimbursement for psychological support during the administration of any FDA-approved psychedelic therapies given to patients. The addition of the psychedelics code was made possible by Compass Pathways Plc. (NASDAQ: CMPS), a company conducting clinical trials of psilocybin treatment using COMP360, COMPASS’s proprietary formulation of synthetic psilocybin, and MAPS Public Benefit Corporation (PBC), two companies developing psychedelics-based treatments for mental health conditions. The two companies submitted a joint application to the AMA to add a new CPT III code for psychedelic therapies. CPT Codes Lend Legitimacy To Emerging Psychedelics Market While no psychedelic has yet been approved by the Food and Drug Administration (FDA) for the market, a growing body of research from the last decade or so has yielded positive data on the therapeutic potential of substances like psilocybin, MDMA or LSD for a range of some of the most common and most difficult to treat mental health conditions. “Psychedelic-assisted therapies represent a potential new frontier in the treatment of mental health conditions and our top priority is ensuring there is a path forward to integrate them into the healthcare system, if FDA approved,” said MAPS CEO Amy Emerson. The new CPT code paves the way for psychedelics – subject to FDA approval – to become a widely adopted set of new therapeutics. “This is a major step forward to enabling broad and equitable access to psychedelic therapies,” said Compass CEO Kabir Nath. CPT coding is a standardized set of codes used nationwide for reporting of medical services and procedures, claims processing and developing guidelines for medical care review. Essentially, if psychedelic therapies are approved, this new code is the basis for what will be used to document treatment in patient medical records and submit claims to payers for reimbursement. COMPASS And MAPS Are Also Edging Closer To FDA Approval With Late Stage Clinical Trials The AMA’s acceptance of COMPASS and MAPS PBC’s new code application puts the mechanisms for adoption in place if either company is granted FDA approval for their psychedelic therapies. With that code in place, both companies are working to move their current late-stage clinical trials through the approval process. A phase 3 trial is already underway for COMP360, the synthetic psilocybin treatment developed for treatment-resistant depression (TRD). The trial is building on the company’s phase 2b trial, in which 30% of TRD patients achieved remission by the third week after taking just one 25-milligram dose at the start of the trial. At the 12-week follow-up, over 20% of patients were still in remission. These results are promising given the challenging TRD patient population. Less than a third of people diagnosed with depression achieve full remission with the first antidepressant they try – and even when they do, it takes an average of about seven weeks of daily medication for remission to happen. For treatment-resistant depression – where a patient has been failed by at least two different antidepressants – the numbers are even worse. Remission rates for patients trying a third antidepressant range from just 8% to 12%, depending on the specific antidepressant tried. From the fourth treatment attempt onward, remission rates remain low. The COMP360 trial outcomes suggest it could be a meaningful alternative for these patients who struggle to find any relief with the current standards of care. The phase 3 program currently underway will be conducted across approximately 150 sites worldwide. Two other phase 2 trials are also being conducted, one for post-traumatic stress disorder (PTSD) and another for anorexia nervosa. Meanwhile, MAPS already has two phase 3 trials under its belt, both for an MDMA-assisted therapy it developed for PTSD. In the first of those trials, 88% of participants saw meaningful improvement in their symptoms with the treatment while 67% responded so well that they no longer met the diagnostic criteria for PTSD after 18 weeks. Based on that data and its previous trials, the company is preparing to submit a new drug application to the FDA in the third quarter of this year. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz stephen.schultz@compasspathways.com

July 25, 2023 09:25 AM Eastern Daylight Time

Novel Chinese medicine for constipation developed by HKBU authorised by U.S. FDA for clinical trial

Hong Kong Baptist University

HONG KONG SAR - Media OutReach - 25 July 2023 - The Centre for Chinese Herbal Medicine Drug Development (CDD) of Hong Kong Baptist University (HKBU) has made significant progress in developing novel Chinese medicine for treating chronic constipation. With its success in the Investigational New Drug Application to the U.S. Food and Drug Administration (FDA), CDD has been authorised to conduct a phase I clinical trial of the new drug. This is the first time that a new botanical drug developed in Hong Kong was authorised to conduct a clinical trial in the US. The clinical trial will be launched later this year to evaluate the safety, tolerability, and pharmacokinetics profile of the new drug on healthy individuals. Research based on traditional Chinese herbal formulation Chronic constipation is a common gastrointestinal disorder affecting approximately 14% of the global population. Currently, many patients with chronic constipation are not completely satisfied with their current treatments due to side effects and/or limited efficacy. In response to the patients' needs for better therapeutics, CDD has been eyeing the international market and has developed a new drug called CDD-2101, which is based on previous pilot clinical studies and basic research on the traditional Chinese herbal formulation "MaZiRenWan". The main ingredients of CDD-2101 include hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root. The HKBU research team collaborated with partners including the University of Chicago and the University of Macau to submit an Investigational New Drug Application for CDD-2101 according to the requirements for botanical drug development of the U.S. FDA and was authorised to conduct a phase I clinical trial. Milestone of standardisation and internationalisation of Chinese medicine Professor Alexander Wai, President and Vice-Chancellor of HKBU, said: "HKBU is committed to promoting the development of Chinese medicine, and conducting cutting-edge scientific and translational research in this area. The University received funding from the Innovation and Technology Commission's InnoHK initiative to establish the CDD in 2020, which significantly boosted our comprehensive capabilities in the research and development of Chinese medicine. The clinical trial in the US will provide us with invaluable experience in conducting clinical trials at Hong Kong's first Chinese Medicine Hospital in future." Professor Bian Zhaoxiang, Associate Vice-President (Chinese Medicine Development), Director of the Clinical Division of the School of Chinese Medicine, and Director of the CDD at HKBU, said: "CDD-2101 is a novel drug developed by combining a traditional Chinese herbal formulation and advanced technologies, with research and manufacturing conducted in compliance with international standards. Obtaining U.S. FDA's authorisation to conduct a clinical trial for this new drug is an important milestone in the development of Chinese medicine in Hong Kong, and it reflects HKBU's capabilities in and dedication to promoting the standardisation and internationalisation of Chinese medicine." Authorisation from the U.S. FDA was secured in April this year to conduct a phase I clinical trial of CDD-2101 in the US. The trial will start later this year and will recruit 20 healthy participants in the US. It will be a randomised, double-blinded, and placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics profile of the drug. Participants will take a single dose of CDD-2101 or a placebo and be monitored for 24 hours. The study will be conducted at a phase I clinical research centre in the US. Phase I trial focuses on safety The phase I clinical trial is expected to be completed in 2024, followed by a phase II study to collect the safety and efficacy data from patients with chronic constipation. A large-scale phase III study will then be launched to further evaluate the treatment efficacy of CDD-2101 in patients with chronic constipation, and monitor any unforeseeable side effects. Professor Bian said: "The ultimate goal of the drug development programme is to collect sufficient safety and efficacy data, so that CDD-2101 can be evaluated and approved by the U.S. FDA as a new pharmaceutical for sale and marketing in the US. This is essential in establishing CDD-2101 as an internationally recognised, safe and effective drug for the treatment of chronic constipation. It is anticipated that another three to five years are needed to complete the phase II and III clinical trials, after which the data gathered during the animal studies and human clinical trials, together with details of the manufacturing of the drug, will be included in a New Drug Application to be submitted to the U.S. FDA for review." The CDD, funded by the Innovation and Technology Commission's InnoHK initiative, is the first integrated Chinese medicine research and development centre at a local university. Located in the Hong Kong Science and Technology Parks and equipped with advanced facilities, the CDD aims to gather world-class partners to translate the wisdom of traditional Chinese medicine wisdom into pharmaceutical products that meet international standards. Since its establishment in 2020, the CDD has been focusing on innovative Chinese medicine research for gastrointestinal and immune-related diseases such as chronic constipation and ulcerative colitis. Contact Details Wong Suk-ling +852 3411 2119 hkbunews@hkbu.edu.hk

July 25, 2023 09:00 AM Eastern Daylight Time

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Immunic Inc eyeing "big step" for multiple sclerosis patients

Immunic Inc

Immunic Inc (NASDAQ:IMUX) president and CEO Dr Daniel Vitt joined Thomas Warner from Proactive ahead of World Brain Day to provide an update on the biotechnology company's novel multiple sclerosis (MS) treatment. Dr Vitt gives an overview of the treatment that Immunic is currently working on, and emphasisedsthe significance of addressing the high unmet medical need for MS patients worldwide. Immunic's focus is on developing a new therapeutic option, using vidofludimus calcium, to treat both relapsing and progressive forms of MS. He says that the drug is the first known modulator of the "so-called Nurr1 target", making it a potential neuroprotective treatment. Immunic is conducting a phase two clinical study into its treatment for progressive MS, with biomarker data expected in the second half of the year. Dr Vitt says registration studies for relapsing MS are progressing well, with an interim analysis anticipated next year. He adds that the MS market holds significant potential due to demand for treatments that strike a good balance between being both effective and tolerable, and says that "if we could confirm in the phase three study that the drug really prevents disability worsening that would be a big step for patients." Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

July 25, 2023 08:00 AM Eastern Daylight Time

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hVIVO signs second bespoke human challenge model contract in as many months

hVIVO PLC

hVIVO PLC (AIM:HVO) chief executive Mo Khan speaks to Thomas Warner from Proactive after announcing that the specialist contract research organisation has begun work on a new Flu B human challenge model as part of a new deal with an existing "large pharma" client company. Khan lays out the timeline for the rest of the work on the contract, suggesting that the "whole manufacturing process" should be complete by the end of Q3, at which point a characterisation study will begin. He adds that if the characterisation study is successful then he hopes the "full blown" human challenge trial can begin in the new year. Khan goes on to describe the potential impact of the model as "quite significant", highlighting some additional funding from the client to help expedite the process. He concludes by saying that hVIVO "is here to build new challenge models to be able to test new drugs and bring new vaccines to the market... overall we are very happy that we're adding a new human challenge model [and] very happy that we're continuing to help our current clients in bringing vaccines to market faster." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 25, 2023 07:38 AM Eastern Daylight Time

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Faron Pharmaceuticals hoping for first filing of BLA in H1 2025

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) Chief Medical Officer Marie-Louise Fjällskog speaks to Thomas Warner from Proactive after releasing an update on progress with the clinical stage biopharmaceutical company's phase I/II BEXMAB study. Fjällskog gives an overview of the update, highlighting several "very nice objective responses" to Bexmarilimab treatment and saying that the data "just confirms that we have some very exciting things going on with our combination." One patient has now stayed on the treatment for 13 months, the company noted in its update. Looking further down the line, Faron said that it expects to file the first Biologics License Application (BLA) to US Food and Drug Administration (FDA) planned by the first half of 2025. Fjällskog also mentions that the company is currently active in recruiting more patients for its study and is opening more sites in the US and potentially in Europe to aid with the effort. Bexmarilimab, a novel anti-Clever-1 humanised antibody, is Faron's investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 25, 2023 06:56 AM Eastern Daylight Time

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Shield Therapeutics "really starting to fire on all cylinders"

Shield Therapeutics PLC

Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) CEO Greg Madison speaks to Thomas Warner from Proactive after the commercial-stage specialty pharmaceutical company released a business update containing plenty of new information about its performance during the second quarter. Madison gives an overview of the update, highlighting strong US sales growth for its Accrufer/Feraccru iron deficiency treatment as a result of the commercial expansion with Viatris that was completed in May, which brought the combined sales team to 100 people. He stresses that the team is "really starting to fire on all cylinders" but "hasn't really hit full stride yet...I think there's more that we can do and we're constantly looking at how we tweak the business and what adjustments we can make to further that growth - but [we're] off to a really nice start." He also mentions a new marketing campaign and the addition of Andy Hurley as Chief Commercial Officer, who he describes as a "veteran on the commercial side... I couldn't be more pleased with his performance." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 25, 2023 06:45 AM Eastern Daylight Time

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News Release

Avricore Health platform HealthTab making health information more accessible to everyone

Avricore Health

Avricore Health CEO Hector Bremner joined Steve Darling from Proactive to share news about the company's innovative pharmacy services. Avricore Health is focused on acquiring and developing early-stage technologies with the goal of advancing pharmacy practices. Their flagship offering, HealthTab, aims to make actionable health information more accessible to everyone by establishing the world's largest network of rapid testing devices in community pharmacies. Bremner provided further details about the HealthTab platform and its rollout across Canada. He discussed the significant opportunities for growth in expanding the availability of HealthTab in pharmacies nationwide. Avricore Health has formed valuable partnerships with major industry players, including Shoppers Drug Mart, Loblaws, Abbott, and Ascensia, to further enhance the accessibility and reach of their services. The company's mission is to revolutionize the way health information is accessed and utilized by individuals. Through their innovative technologies and strategic partnerships, Avricore Health is driving the advancement of pharmacy services and facilitating greater engagement in personal health management. By leveraging the power of community pharmacies and rapid testing devices, Avricore Health aims to empower individuals to take a more proactive role in monitoring their health. Their vision of creating a widespread network of accessible and actionable health information holds tremendous potential to improve overall health outcomes and revolutionize the pharmacy industry. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

July 24, 2023 01:27 PM Eastern Daylight Time

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