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Multi-Billion Dollar Treatment Market For Lung Infection That Causes Over 200,000 Hospitalizations Annually With Elderly, Young At Most Risk Has Game-Changing New Entrant

NanoViricides, Inc.

By David Willey, Benzinga Read the latest report on NanoViricides here The CDC recently issued a warning that Respiratory Syncytial Virus (RSV), a common and highly contagious lung infection that can cause bronchitis and pneumonia, is on the rise in the Southeastern United States – and the very young and the elderly are the most at risk of developing severe incidences of RSV. Every year, there are over 2 million outpatient (non-hospitalized) cases of RSV in children under 5, and RSV is the leading cause of hospitalizations for young children. There are up to 80,000 hospitalization cases for children under 5, and there are also up to 160,000 cases of patients over 65 getting hospitalized with RSV. Up to 300 children under 5 and 10,000 adults over 65 die of RSV annually. Despite this serious disease, there were no vaccines or good treatment options until recently. The recently approved vaccines from GSK plc (NYSE: GSK) and Pfizer (NYSE: PFE) also have severe limitations. These vaccines are only for use in patients aged 60 and over. However, these vaccines can involve side effects, including atrial fibrillation, Guillain-Barré syndrome and another potentially related disorder. A recently approved vaccine for pregnant women to protect the newborn infant upon birth has the risk of preterm births. In July 2023, the FDA also approved Beyfortus, an antibody treatment for children delivered as an injection to help prevent the development of RSV. Beyfortus was developed by Sanofi (NASDAQ: SNY) and AstraZeneca (NASDAQ: AZN). It is expected to be better than a previously approved antibody (palivizumab, trade name Synagis, developed by MedImmune, now marketed by SOBI – Swedish Orphan Biovitrum) for the same indication. Like the vaccines, however, there are side effects associated with these protective antibody treatments, which can include anaphylaxis, a severe allergic reaction. Yet, there are no treatments for RSV infection except for severe hospitalized cases when children at risk of dying are given the toxic drug ribavirin at very high doses as a last resort. The market for therapeutics for RSV was worth $1.8 billion in 2022 and will reach $8.73 billion by 2031 at a compound annual growth rate (CAGR) of 18.9% during the forecast period, according to a recent report from Growth Plus Therapeutics. Note that there were no real treatments, only one protective antibody, Synagis, available in 2022. The therapeutic used for treating RSV is Ribavirin, a highly toxic compound also used as a therapy for hepatitis C. However, Ribavirin carries with it some severe side effects, including the destruction of red blood cells, leading to liver, kidney and spleen toxicities and failures – which limit its use to patients with a high risk of progressively severe RSV. The primary concerning side effect of Ribavirin is anemia, a decrease in red blood cells that can cause a drop in hemoglobin. Ribavirin-induced anemia can manifest within two weeks of starting the therapy and can get worse as the drug dosage increases. NanoViricides Treatment For RSV NanoViricides (NYSE American: NNVC), a leading developer of antiviral treatments through its nanomedicines platform, is developing a safe and effective alternative therapeutic for RSV. Its drug candidate, NV-387, has already been shown to not have the toxicity or side effects associated with Ribavirin, according to the company. It reports that in the recent pre-clinical animal study, NV-387 almost matched the efficacy of Ribavirin with no toxicity. This animal study was designed to mimic the lethal lung pneumonia in infants caused by RSV infection. Importantly, NV-387 is already in phase 1 human clinical trials as the active ingredient in the company’s COVID drug candidate NV-CoV-2. The company has just reported that it was found to be completely safe, with no side effects found to date, in this continuing phase 1 Study. For this reason, the company anticipates soon being able to advance NV-387 to a phase 2 human clinical trial against RSV. If the results of animal studies are replicated in humans, this nanoviricides drug could become truly a game-changer in the treatment of RSV infections. Learn more about NanoViricides’ NV-387 antiviral here. About NanoViricides NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate Remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with Remdesivir encapsulated in it. The Company believes that since Remdesivir is already US FDA approved, our drug candidate encapsulating Remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice. Contact Details NanoViricides, Inc. +1 203-937-6137 info@nanoviricides.com Company Website http://www.nanoviricides.com

September 27, 2023 08:45 AM Eastern Daylight Time

Graft Polymer's new Slovenian plant key to unlocking industrial-scale solutions

Graft Polymer (UK) PLC

Welcome to Wednesday's business update. In this video, we focus on Graft Polymer (UK) PLC's milestone—the commissioning of its expanded Slovenian plant. Chairman Roby Zomer says this new facility doubles the company's production capacity to 6,000 tonnes per year and opens doors for industrial-scale partnerships. We'll also delve into the company's recent contract achievements, including a significant U.S. approval for its GraftBio drug delivery system. Where it has been approved for sale over-the- counter as a part of the MGC Pharma ArtemiC COVID treatment. Stay tuned as we explore how these developments are setting the stage for Graft Polymer's future growth and market expansion. The core business of the group comprises polymer modification and drug delivery system developments. The group has developed a proprietary set of polymer modification technologies which uses recycled raw materials and a closed loop system to reduce waste. Towards the end, we'll touch upon the financials, examining the 27% drop in revenue to £240,000 and the 35% increase in operating losses to £1.03 million during this pivotal transition period. For more information on the company, and to see interviews with the Chairman, Roby Zomer, visit: https://www.proactiveinvestors.co.uk/LON:GPL/Graft-Polymer-UK-PLC Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 27, 2023 08:06 AM Eastern Daylight Time

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News Release

Magdalena Biosciences JV with Filament Health and Jaguar Health completes coca leaf import

Filament Health Corp

Filament Health CEO Ben Lightburn joined Steve Darling from Proactive to announce a significant development involving Magdalena Biosciences, a joint venture established by Filament Health and Jaguar Health. The development pertains to the successful import of coca leaf to Filament's Metro Vancouver research and development facility. Lightburn explained that the import was authorized by the Peruvian Health Authority and was sourced from the only company in Peru authorized to collect, distribute, and export coca leaf and its derived products. The imported coca leaves were received by Psilo Scientific, a wholly-owned subsidiary of Filament Health. These coca leaves will be utilized for initial research purposes, focusing on exploring neuropsychiatric indications. Magdalena Biosciences and Filament Health are currently in the process of seeking full compliance with the Nagoya Protocol in Peru. The Nagoya Protocol is an international agreement designed to ensure the fair and equitable sharing of benefits arising from the utilization of genetic resources and associated traditional knowledge held by indigenous and local communities. This development highlights Filament Health's commitment to advancing its research initiatives and exploring the therapeutic potential of natural resources, while also ensuring compliance with international agreements and ethical considerations. The research conducted through this joint venture has the potential to contribute valuable insights to the field of neuropsychiatric indications, ultimately benefiting patients and the broader healthcare industry. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

September 25, 2023 01:49 PM Eastern Daylight Time

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A Very Important Change Is Coming for Airplane Bathrooms

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/g4fqkbuzqjA The Department of Transportation (DOT) is making larger single-aisle airplanes more accessible by requiring accessible lavatories for people with disabilities. While this rule will be implemented over the coming years, it is a monumental achievement for the disability civil rights movement. Under previous standards, people who use wheelchairs have no way to access the restroom on single-aisle aircraft. They are forced them to dehydrate themselves, or even soil themselves, before flights – causing major bodily harm! Over the past 75 years, Paralyzed Veterans of America (PVA) has led the fight for accessibility — and air travel is no different. PVA helped pass the landmark legislation to first make air travel accessible over 35 years ago, and they played an integral role in securing accessible airplane lavatories. They continue to advocate for additional reforms that will ensure a safe, dignified air travel experience for people with disabilities. So, what does this new rule mean for the future of accessible air travel? And what else is needed to make the air travel experience fully accessible for people with disabilities? Now is an opportunity for your audience to learn more about the new rule and the ways Paralyzed Veterans of America (PVA) has helped secure this monumental achievement, and how they continue to advocate for other meaningful reforms related to the upcoming renewal of the Federal Aviation Administration. A nationwide media tour was conducted featuring Chief Policy Officer at Paralyzed Veterans of America, Heather Ansley discussing the new lavatory rule and additional reforms that must be made to make air travel fully accessible through the reauthorization of the FAA. Additional topics that were discussed included: What the new Department of Transportation rules will do. What this means for the disability community. Why this DOT rule was desperately needed. The reasons why air travel is so far behind basic standards. What else needs to be done to ensure air travel is accessible. PVA remains on the forefront of the disability civil rights movement – fighting for stronger ADA enforcement, expanding support for home-based care, and more. To join PVA’s fight for greater enforcement of the ADA, visit PVA.org/ADA, or for air travel, visit PVA.org/AirTravel. About Paralyzed Veterans of America Paralyzed Veterans of America is a 501(c)(3) non-profit and the only congressionally chartered veterans service organization dedicated solely for the benefit and representation of veterans with spinal cord injury or diseases. The organization ensures veterans receive the benefits earned through service to our nation; monitors their care in VA spinal cord injury units; and funds research and education in the search for a cure and improved care for individuals with paralysis. As a life-long partner and advocate for veterans and all people with disabilities, PVA also develops training and career services, works to ensure accessibility in public buildings and spaces, and provides health and rehabilitation opportunities through sports and recreation. With more than 70 offices and 33 chapters, Paralyzed Veterans of America serves veterans, their families, and their caregivers in all 50 states, the District of Columbia, and Puerto Rico. Learn more at PVA.org. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

September 25, 2023 10:40 AM Eastern Daylight Time

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Oxford Cannabinoid Technologies reports no adverse events in OCT461201 trial

Oxford Cannabinoid Technologies Holdings PLC

Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTCQB:OCTHF) chief executive Clarissa Sowemimo-Coker speaks to Thomas Warner from Proactive London after the pharmaceutical group announced it has successfully administered the final dose of its lead drug candidate, OCT461201, as part of its phase I clinical trial. Sowemimo-Coker says that no adverse events were reported during the trial, which began in late July. While awaiting the final report, the company remains optimistic about the results. She briefly touches upon the potential move into phase two studies for the compound, saying that external advisor Dr William Paul Farquhar-Smith and Chief Medical Officer Dr. Tim Corn are actively planning these next steps. Additionally, the company's AGM is slated for Thursday, presenting another opportunity for shareholder engagement. Oxford Cannabinoid Technologies is a pharmaceutical group developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the U$ multi-billion pain market. The group is developing OCT461201 as a potential treatment for chemotherapy-induced peripheral neuralgia (CIPN). Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 25, 2023 06:00 AM Eastern Daylight Time

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News Release

Lophos Pharmaceuticals announces company is now trading on the CSE under the ticker MESC

Lophos Pharmaceuticals

Lophos Pharmaceuticals CEO Claire Stawnyczy joined Steve Darling from Proactive to share the news that the company which specializes in the cultivation, research, and sale of Lophophora williamsii or peyote cactus has achieved significant milestones. Lophos Pharma has commenced trading on the Canadian Securities Exchange (CSE) under the ticker symbol "MESC." This development marks a significant step for the company in terms of visibility and accessibility to investors. The company has successfully obtained a Controlled Substances Dealers License from Health Canada. This license empowers Lophos Pharma to engage in various activities related to controlled substances, including possession, production, sale/provision, sending, transportation, and delivery. The controlled substances covered by this license include mescaline, psilocin, and psilocybin. Lophos Pharma has entered into a strategic partnership with KGK Science to explore potential pathways to market sustainably grown, peyote-derived natural health products. While peyote itself is legally recognized in Canada, mescaline—the psychoactive compound derived from the peyote cactus—remains classified as a Schedule 3 controlled substance. These developments underscore Lophos Pharma's commitment to advancing its unique position in the emerging market of natural health products derived from peyote. The company's ability to obtain a Controlled Substances Dealers License is particularly noteworthy, as it positions Lophos Pharma to engage in research, production, and distribution of controlled substances in compliance with Canadian regulations. As Lophos Pharma continues its work in researching and developing peyote-derived products, its collaboration with KGK Science represents a key partnership to explore the potential for sustainable and legal market opportunities in this evolving sector. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

September 22, 2023 01:34 PM Eastern Daylight Time

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How COMPASS Pathways Is Leveraging AI To Revolutionize The Mental Healthcare Space

COMPASS Pathways

By Faith Ashmore, Benzinga Artificial Intelligence (AI) is rapidly penetrating a number of different sectors, including healthcare. The use of AI in mental health has opened up the possibility of new avenues of care, potentially allowing for more efficient diagnosis, treatment and patient care. Machine learning algorithms can analyze vast amounts of data – including patient medical records, genetic information and environmental factors – to potentially identify patterns and predict disorders. Clinicians can also benefit from more accurate and timely diagnoses based on objective digital signals. COMPASS Pathways (NASDAQ: CMPS) is currently developing AI-informed digital systems to assist an investigational treatment for mental health conditions, including treatment-resistant depression (TRD), anorexia nervosa and post–traumatic stress disorder (PTSD). The company is best known for its investigational psilocybin treatment and its R&D focus on mental health conditions. Its goal is to develop new and more effective treatment options for individuals with treatment-resistant depression and other difficult-to-treat mental health conditions. The company’s innovative approach has already yielded promising results, and they received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the U.K. for their investigational COMP360 psilocybin treatment. In late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America. However, the company believes that drug innovation alone is not enough to improve mental health care. In addition to COMP360 and to better support the drug, COMPASS Pathways has developed three digital tools to help support patients and therapists to ensure the best possible treatment. While these tools will be used in tandem with the COMP360 treatment, the tools were built to be scalable and revolutionize the treatment of mental health disorders. Therapist COMPanion is a web-based portal that supports therapists through all phases of patient care. Psilocybin administration is relatively new to providers so Therapist COMPanion acts as a tool for the provider to ensure that treatment is conducted in the right way. myPathfinder is a patient-facing app that provides guidance throughout COMP360. The psilocybin treatment is grouped into three phases: preparation, administration and integration. COMPASS Pathways was built on the belief that patients deserve better care, especially patients who have been underserved and felt overlooked by the system after being diagnosed as treatment-resistant. This platform is an essential component of taking better care of the patient and ensuring they have the tools to understand their treatment and psilocybin experience. However, the company’s most expansive digital tool is Chanterelle, an AI and analytics infrastructure that can be used for continuous optimization throughout treatment, as well as data collection to help expand a deeper understanding of treatment-resistant disorders. The program records sessions with the patients, with their consent, and can glean a better understanding of success rates using AI and natural language processing. Chanterelle uses the BART large language model which denotes the valence and arousal of the participant and therapist to assess the emotional tenor of the conversation and to better understand if treatment is succeeding. Chanterelle’s application could go beyond COMP360 and was designed to be scalable. The company is working to provide a more concrete and evidence-based way of measuring the success of treatment. While COMPASS Pathways is not the only mental healthcare company to bridge the gap between AI and care, the company’s ability to design platforms that can be used for a variety of disorders sets it apart from competitors like MindMed and Medtronic. Featured photo by Steve Johnson on Unsplash 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

September 22, 2023 08:30 AM Eastern Daylight Time

Synairgen looking beyond COVID in fight against respiratory illness

Synairgen PLC

Synairgen PLC (AIM:SNG, OTC:SYGGF) chief executive Richard Marsden speaks to Thomas Warner from Proactive London about the company's ongoing efforts to develop what he describes as a "drug to help patients handle respiratory viruses." He explains that work on the drug long predates the COVID pandemic and has intensified since, but is careful to emphasise that the intention of Synairgen is to develop a respiratory drug that can be of use to patients with other respiratory conditions as well. He notes the importance of looking beyond COVID-19, given the unpredictability of its media presence and its potential long-term existence alongside other viruses. Marsden discusses their past Sprinter trial and the need for targeted future clinical trials. Utilising technologies and data that emerged during the pandemic, Synairgen plans to identify patients most likely to deteriorate due to the virus. This strategic approach aims to conduct faster trials with a higher chance of success. Marsden concluded that as they refine patient selection for upcoming trials, they'll announce results and commence the next clinical trial phase. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 21, 2023 08:40 AM Eastern Daylight Time

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Genflow Biosciences reports positive news from Belgium

Genflow Biosciences PLC

Genflow Biosciences PLC (LSE:GENF, OTC:GENFF) CEO Dr. Eric Leire speaks to Thomas Warner from Proactive after the longevity-focused UK based biotech company released a company update highlighting a successful first regulatory interaction with the Federal Agency for Medicines and Health Products (FAHMP) in Belgium. Dr Leire explains that the news helps pave the way for clinical trials and was particularly noteworthy because of the agency's recommendation to commence directly with NASH (Non-Alcoholic Steatohepatitis) patients, bypassing the traditional phases. He expects the move to accelerate the proof of concept process and boost the company's valuation. Additionally, a strategic restructuring is underway, aimed at enhancing eligibility for grants, a crucial aspect in mitigating financial risk for early-stage biotech ventures. Dr Leire explains that the move aligns with Genflow's strategy of minimising reliance on venture capital funding and focusing instead on attracting non-dilutive grants. He also draws attention to planned FDA interaction and promising in vivo studies. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 20, 2023 07:10 AM Eastern Daylight Time

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