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Revolutionizing Mental Healthcare With The Rise Of Ketamine And Psychedelic Therapies

Benzinga

By Faith Ashmore, Benzinga In the world of mental healthcare, there has been growing criticism over traditional drugs that treat depression. Traditional drugs that treat depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), primarily target the levels of neurotransmitters in the brain, specifically serotonin and norepinephrine, to alleviate symptoms of depression. These medications work by blocking the reuptake of these neurotransmitters, allowing them to accumulate in the brain and enhance mood regulation. However, SSRIs and SNRIs have received criticism for their potential side effects, such as sexual dysfunction, weight gain and withdrawal symptoms. More and more studies are coming out questioning their efficacy as well. As antidepressants are looking less shiny to consumers and scientists, it begs the question, what is the alternative? Is Ketamine The Answer To Hard To Treat Mental Illnesses? In recent years, alternative treatments for hard-to-treat mental illnesses like treatment-resistant depression (TRD), bipolar 2 and PTSD have become increasingly common and sought-after. Drugs like MDMA and ketamine have gotten attention for being often more effective and less dangerous than traditional medicine. Ketamine, which is a dissociative anesthetic, targets the glutamate system in the brain, specifically the NMDA receptors, and modulates the release of neurotransmitters like glutamate. By doing so, ketamine can rapidly improve depressive symptoms, often within hours or days, in contrast to the weeks or months that traditional antidepressants may require. Psychedelics, like ketamine, are emerging as a potential treatment option for mental health conditions by disrupting rigid neural pathways associated with depression, anxiety, and other disorders. Research indicates that these substances have the potential to promote neuroplasticity and restore neural circuits, ultimately leading to improved mental health outcomes. For patients who are struggling under the weight of a difficult-to-treat mental illness, these alternatives can be life-saving. Even high-profile celebrities like Elon Musk have opened up about their success with ketamine as a depression treatment. Companies like SiloPharma Inc. (NASDAQ: SILO) are at the forefront of developing alternative treatments for conditions such as depression. With a focus on underserved areas, including PTSD, stress-induced psychiatric disorders, chronic pain and central nervous system diseases, SiloPharma aims to provide novel therapeutics to address these unmet needs. They have built a growing pipeline of opportunities, leveraging the promising potential of psychedelic drugs and conventional formulations. The company recently conducted a study in partnership with Columbia University, which explored new pathways involved in mood regulation. This study yielded promising results, showing significant improvements in patient mood stability without the common side effects of existing antidepressants. As a result, Silo has successfully progressed SPC-15 through pre-clinical development and is now preparing to submit a pre-investigational New Drug Application (IND) to the FDA. This application will focus on SPC-15's use in treating PTSD, a lead indication for the drug. “The recently completed study demonstrated marked improvements in mood stability, which we see as a potentially significant development for combatting depression and preventing relapse,” said Silo CEO Eric Weisblum. “While advancing our SPC-15 program in PTSD to the clinic remains our top pipeline priority, we are excited about these encouraging new results and the additional potential for treating millions of people affected by depression which could ultimately expand our pipeline.” Silo has exercised its option to license SPC-15 from Columbia University, as outlined in its sponsored research and option agreement established in 2021. The license agreement, currently in the finalization stage, will grant Silo the exclusive rights to further develop, manufacture and distribute SPC-15 globally. Completion of the exclusive license agreement is expected by the first half of 2024. SiloPharma is not alone in the pursuit of alternative treatment for mental health; Atai Life Sciences (NASDAQ: ATAI) and Field Trip Health Ltd (NASDAQ: FTRP) are both exploring R-ketamine and MDMA treatments, respectively. For patients who are in desperate need of alternative treatment, ketamine is looking like a viable option, and companies like SiloPharma are helping to make that more possible. Featured photo by Pawel Czerwinski on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

May 22, 2024 08:55 AM Eastern Daylight Time

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MAIA Biotechnology's Unique Telomere Targeting Agent Currently In Clinical Development Shows Promise For The Multi-Billion Dollar Cancer Therapy Market

Benzinga

By Kyle Anthony, Benzinga MAIA Biotechnology (AMEX: MAIA) is a cutting-edge biopharmaceutical company dedicated to developing innovative therapies for cancer treatment. The company’s mission is to discover, develop and deliver transformative cancer therapies that improve patients' lives worldwide. MAIA Biotechnology envisions a future where cancer is manageable and patients can live longer, healthier lives. The firm is at the forefront of revolutionizing oncology, leveraging advanced scientific research and technological advancements to drive its progress, with the goal of bringing treatments that target cancer's replication mechanism in a more efficacious and less harmful manner than traditional therapies. Company Background Founded in August 2018 and headquartered in Chicago, Illinois, MAIA Biotechnology is led by an experienced management team and supported by scientific advisors with extensive drug development experience who are committed to advancing promising agents into human clinical trials. MAIA Biotechnology specializes in telomere-targeting therapies for cancer treatment. As such, the firm’s current product focus is the development of first-in-class drugs that target proteins that control how cancer cells grow, divide and spread. MAIA Biotechnology's pipeline includes several promising candidates in various stages of development, but its premier product offering is THIO (6-thio-2′-deoxyguanosine), a first-in-class telomere-targeting agent designed to selectively kill telomerase-positive cancer cells, which are present in most human cancers. The Role Of Telomeres In Cancer Telomeres play a crucial role in cellular aging and cancer development. Research published by the Dana-Farber Cancer Institute explains that cancer cells often avoid senescence or cell death by rebuilding and maintaining their telomeres despite repeated cell divisions. This is possible because the cancer cells activate an enzyme called telomerase, which adds genetic units to the telomeres to prevent them from shortening to the point of causing cell death. As a result, cancer cells essentially become immortal. Telomerase is silenced in most normal cells but is active in an estimated 85% to 95% of human cancer cells. Since telomerase is active in cancer cells but not normal cells, it is seen as a promising target for cancer therapy. Due to telomerase inhibition, activity or expression, telomere-targeting drugs might kill tumor cells by allowing telomeres to shrink or by provoking apoptosis, the process of programmed cell death. By incorporating into telomeres, THIO disrupts their function, leading to cancer cell death. This approach has shown promising preclinical results and has been undergoing clinical trials. Product Development Pipeline THIO is MAIA Biotechnology’s most advanced product offering, which has shown positive efficacy findings in treating advanced non-small cell lung cancer (NSCLC) in clinical trials. The ongoing clinical trial is testing the hypothesis that lower doses of THIO administered before immune checkpoint inhibitor Libtayo® treatment (i.e., stimulation of the immune system to attack cancer cells) would enhance and prolong responses in subjects with advanced NSCLC who did not respond or progress after first-line treatment with a checkpoint inhibitor, a type of drug that blocks proteins called checkpoints that are made by some types of immune system cells such as T cells and some cancer cells. These checkpoints help keep immune responses from being too strong and sometimes can keep T cells from killing cancer cells. The clinical trial's positive results support THIO's tolerability and safety as an anticancer therapy and a priming immune activator. Treatment with THIO sequenced with Libtayo® treatment was found to be well-tolerated in a heavily pre-treated population thus far. MAIA Biotechnology is also researching other drug treatments, using its expertise in telomere-targeting agents as a foundation. The company’s second-generation program aims to discover new compounds with potentially improved specificity toward cancer cells relative to normal cells and potentially increased anticancer activity. This program will allow MAIA Biotechnology to strengthen its patent portfolio over time, which already has five issued patents and 29 applications pending worldwide. Market Potential and Industry Impact Research published by Coherent Market Insights estimates the cancer therapy market will be worth $205.10 billion in 2024 and is expected to reach $466.21 billion by 2031. The driving factors behind this growth are the rising occurrence of cancer worldwide and the increasing demand for cancer treatment. As such, MAIA Biotechnology‘s THIO addresses a large and growing market. As outlined in their most recent corporate presentation, lung and colon cancer are the first and second most prevalent cancer types globally, respectively, and treating them specifically would generate billions in sales. Given the current opportunity, MAIA Biotechnology will continue to protect its intellectual property while expanding its patent portfolio. Recently, the Food and Drug Administration (FDA) granted a third orphan drug designation (ODD) to THIO as a treatment for glioblastoma; the drug also holds ODDs for hepatocellular carcinoma and small-cell lung cancer. The glioblastoma market is expected to grow from $2.2 billion to $3.2 billion globally in the next three years. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially feasible for companies. These include up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S., and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021. Conclusion MAIA Biotechnology’s approach to cancer treatment differentiates it from its peers, potentially placing the company in a unique market position. As incidences of cancer continue to rise globally, drug treatment options, such as THIO, will likely rise in demand. As such, the benefit that MAIA Biotechnology provides and the value proposition the firm espouses will likely continue to have industry resonance. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

May 22, 2024 08:30 AM Eastern Daylight Time

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AGC Biologics and BioConnection Partner to Offer new End-to-End Biopharmaceutical Drug Substance and Drug Product Development and Manufacturing Offering

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and BioConnection, a specialized contract manufacturing organization (CMO) focusing on aseptic filling of vials and syringes for clinical and commercial production, today announced a new strategic partnership. The companies are partnering to provide end-to-end biopharmaceutical development and manufacturing capabilities for drug substance and drug product using the development and manufacturing expertise of AGC Biologics and the specialized aseptic filling capabilities of BioConnection. The new partnership offers a seamless, full-service clinical-stage development and manufacturing solution that accelerates timelines and brings life-saving therapies to market more efficiently. By combining world-class drug substance and drug product services, AGC Biologics together with BioConnection now offer one convenient “gene to vial” value chain service with a single contract and project management team for the project lifecycle. Further, developers will save time and resources by avoiding long, complex processes associated with negotiating a separate drug substance and drug product contract and be able to conveniently plan drug filling activities for as soon as their substance release is scheduled – all through this new offering. New Solution for Companies Potentially Impacted by U.S. BIOSECURE Act This new strategic partnership addresses the ongoing needs of the industry in the wake of the proposed U.S. BIOSECURE Act. By having a combined end-to-end solution that uses facilities in Japan, the United States and Europe, developers now have a reliable and secure supply of services for development, manufacturing (including freeze-drying) and aseptic filling for their drug product’s needs. AGC Biologics is especially well-positioned to support the needs of developers that may be impacted by this legislation, as it is one of the largest CDMO networks in the world offering single-use bioreactor technology. Developers seeking alternatives from their current outsourcing partner benefit from access to AGC Biologics’ single-use network utilizing ubiquitous bioreactor technology, enabling an easier transfer of platform processes and reduction in process changes associated with changing outsourcing partners. Combined Expertise and Resources Through this new joint offering AGC Biologics and BioConnection are providing comprehensive solutions to meet the increasing demand for high-quality biopharmaceutical manufacturing services, while also continuing to offer their services independently. AGC Biologics offers a broad range of protein-biologics services spanning from cell line development to commercial-scale manufacturing across its global network of facilities on three continents, supporting drug substances for microbial and mammalian-based systems, plasmid DNA (pDNA) and messenger RNA (mRNA). With a proven track record of delivering innovative biopharmaceutical solutions to clients worldwide, including supporting more than a dozen commercial products since 2018, AGC Biologics is renowned for its teams with deep technical and scientific expertise at its global facilities, and a commitment to quality, reliability, meeting product timelines and collaborating with developers to meet their needs. BioConnection specializes in aseptic filling of vials and syringes, providing clients with tailored solutions for both clinical and commercial production of either liquid or freeze-dried products. Equipped with state-of-the-art facilities and a highly skilled team, BioConnection is dedicated to ensuring the highest standards of product quality and safety. Clients have valued BioConnection since 2005 for this and for its unmatched customer-oriented approach. “Now more than ever global pharmaceutical companies and developers need reliable facilities to produce and fill their drug products, and by combining our resources with BioConnection we are offering a new end-to-end solution for them under one contract with AGC Biologics,” said Patricio Massera, CEO of AGC Biologics. “We believe BioConnection has a strong acumen, and this partnership will enhance our biopharmaceutical manufacturing offering by providing drug product services for protein biologics, allowing us to create deeper relationships with developers to help get their products to patients in need.” Similarly, Alexander Willemse, CEO of BioConnection, commented, "We are excited to join forces with AGC Biologics to offer integrated manufacturing solutions that address the complexities of biopharmaceutical development. Together, we are well-positioned to support our clients at every stage." For more information about AGC Biologics please visit www.agcbio.com. Visit www.bioconnection.eu to learn more about BioConnection. About BioConnection: BioConnection is a specialized contract manufacturing organization (CMO) focusing on aseptic filling and lyophilization of vials and syringes for clinical and commercial production. With state-of-the-art facilities, a proven successful EMA and FDA track record and a team of experienced professionals in Oss, The Netherlands, BioConnection provides tailored solutions to meet the unique needs of clients in the biopharmaceutical industry. BioConnection is specialized in fill & finish and lyophilization of small and large molecules, orphan drugs, personalized medicine and controlled substances. Its customers value BioConnection for its reliability. BioConnection is renowned for its reliability, with customers appreciating the certainty of delivery made possible by its extensive capacity. The company combines this reliability with a personalized approach to client relations. Discover more at www.bioconnection.eu. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com BioConnection Dennis Link +31 412 846 036 Company Website https://www.agcbio.com/

May 22, 2024 06:00 AM Eastern Daylight Time

Limula raises $6.8M to democratise access to life-saving Cell and Gene Therapies with Swiss-made manufacturing platform

limula

Over the last decade, several breakthrough Cell and Gene Therapy products have been approved in the USA and Europe to turn stem cells and immune cells into ‘living cures’, bringing hope to millions living with life-threatening conditions. However, these treatments remain out of reach for 98% of patients suffering from what are now curable conditions. This is in part due to complex, manual and costly manufacturing processes. Life science startup Limula announces today it has raised CHF6.2M ($6.8M) to take their solution for automating cell therapy manufacturing to the next stage of development. The oversubscribed seed round was led by LifeX Ventures, with participation from Verve Ventures, Zühlke Ventures, Oxford Seed Fund, Lichtsteiner Foundation, W.A. de Vigier Foundation, the founders, and a lineup of private individuals who have been supporting Limula’s vision from its inception. The company was founded in 2020 by Dr. Yann Pierson, Dr Luc Henry. Dr. Thomas Eaton to deliver a disruptive approach to the ‘ex vivo’ manipulation of cells, based on a novel technology. The trio witnessed that outdated manufacturing methods were a speed bump to the adoption of Cell and Gene Therapy products – like chimeric antigen receptor (CAR) T-cells. Combining breakthrough discoveries in genetic engineering and medicine led to a revolution in medicine, but boosting the patients’ own cells to produce a dose in a laboratory still requires too many manual steps. Highly skilled labour and sterile infrastructures represent the majority of the costs of a therapy, leading to a price tag of $500,000 or more per dose. As a result, these treatments are inaccessible for a majority of eligible patients. To combat this, Limula developed a modular solution for on-demand and at-scale manufacturing of cell therapies in a single device. By combining the functionalities of a bioreactor and a centrifuge into one single closed vessel, Limula’s proprietary solution can handle a wide range of volumes and cell numbers, removing transfer steps and therefore limiting stress, losses, and potential contamination. With a potential for scalability, it can be used by cell therapy providers in their transition from pre-clinical evaluation to clinical trials, and later commercial scale manufacturing of clinical-grade cell products. Luc Henry, co-founder and CEO of Limula said: "Our team is driven by the ambitious goal of developing tools that are based on a fundamentally novel way of manipulating cells outside of the body. Our technology supports manufacturing workflows that are impossible to automate with existing tools. We believe automation is the only route to scalability and digital traceability. These two aspects are keys unlocking the full potential of Cell and Gene Therapy, making them accessible to the many, not just the few”. Limula’s founders built a high performing multidisciplinary team, most recently joined by domain experts Olivier Waridel, former CEO of Cytiva-owned Biosafe, Caroline Boudousquié, former Head of Process Development at the Center for experimental therapeutics (CTE) of the University Hospital in Lausanne, and Maria Elena Grisostolo, former VP Operations at Lunaphore. After completing an initial proof of concept, the company launched a program to provide selected industry and academic partners access to the innovative platform ahead of its commercial launch. With the aim to broaden the scope of applications, Limula has signed partnerships with several research centres including San Raffaele Telethon Institute for Gene Therapy in Milan, Italy - a world-recognized centre of excellence for research and clinical translation of cell and gene therapy. Prof. Bernhard Gentner at San Raffaele Telethon Institute for Gene Therapy said: “We believe the solution Limula is advancing can support our current process development activities and later enable the manufacturing of these cell products at scale. We also see its potential in improving the status quo in Cell & Gene Therapy manufacturing in general, and in the field of haematopoietic stem cell transplantation in particular.” Dr Inaki Berenguer, managing partner at LifeX Ventures added: "We're thrilled to stand with the Limula team as they reinvent cell and gene therapy manufacturing. It's evident that production tools have lagged behind scientific and clinical advancements, particularly in terms of price and scalability. Limula's commitment to addressing these bottlenecks is crucial to enhancing accessibility for patients.” Looking ahead, Limula will use its new seed capital to significantly advance the development of the proprietary platform composed of a device and single use consumables, towards meeting good manufacturing practice (GMP) requirements. The solution developed by Limula is an enabling tool for a rapidly growing market. The potential of Cell and Gene Therapies to save the lives of millions of patients globally has generated significant interest – and investment – leading to a significant pipeline and several recent approvals by health authorities. Both industrial and academic players are now eager to adopt next-generation automated and scalable solutions with the shared goal to significantly increase market reach and broaden accessibility. About Limula Limula SA is a Life Science Tools company based in Lausanne, Switzerland, looking to disrupt the status quo in the manufacturing of Cell & Gene Therapies. Their mission is to support rapid and cost-effective introduction of new advanced therapy products to the market. Their cell processing platform leverages a proprietary design and automation to bring all functionalities required for on-demand and at-scale manufacturing of cell therapies in a single device. www.limula.ch About LifeX Ventures ‍LifeX Ventures is a New York-based venture capital firm investing in global visionary entrepreneurs using software and AI to develop transformational solutions that will extend the life of humans and the planet. With its $100M debut fund, LifeX is targeting the two largest sectors in the world: People (bio/health) and Planet (climate), where Software and AI suddenly matter. ‍www.lifex.vc About Verve Ventures Verve Ventures is one of the most active venture investors in Europe with over 140 science and technology-driven startups in its portfolio. Verve Ventures’ dedicated team helps startups with their most pressing needs such as hiring, client introductions, and an expert network of high-profile individuals. www.verve.vc About Zühlke Ventures Zühlke Ventures is an early stage venture capital investor with focus on HealthTech. Zühlke Ventures’s investment is paired with actionable expertise for finding product-market-fit, for developing and deploying novel products, and for entering international markets. www.zuehlke.com/en/about-us/ventures About Oxford Seed Fund Oxford Seed Fund, run by the Entrepreneurship Centre at Saïd Business School is the largest student-led VC fund outside of North America, investing in top Oxford-affiliated technology enabled pre-seed and seed stage companies. Supporting them with access to funding, talent, skills and networks. The Fund deploys £600,000+ per year across 10+ companies. https://www.sbs.ox.ac.uk/research/centres-and-initiatives/entrepreneurship-centre/oxford-seed-fund About Lichtsteiner Foundation The Lichtsteiner Foundation supports pioneers and early-stage startups in the field of health (medical technology, biotechnology, life science, mental health, public health and wellbeing) in order to improve people’s health in a sustainable way. https://lichtsteinerfoundation.org/ About W.A. de Vigier Foundation Since the foundation’s establishment in 1987, the goal of the W.A. de Vigier Foundation has been to actively invigorate business development and further provide direct financial support to young people with innovative business ideas wishing to build performance and growth-oriented businesses in Switzerland. Until today, the W.A. de Vigier Foundation has awarded CHF 14.3 million in seed capital to Swiss startups. https://devigier.ch/ Contact Details Limula Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://limula.ch/

May 21, 2024 09:00 AM Eastern Daylight Time

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Immunic CMO discusses role of clinical trials in biotech development for Clinical Trials Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses the importance of clinical trials in the biotech industry to mark Clinical Trials Day on May 20. Dr Muehler noted that Immunic focuses on translating research ideas into clinical trials to demonstrate clinical proof of concept as well as safety and efficacy of a drug candidate. He explained the stages of clinical development, from preclinical trials to late-stage phase 3 trials and commercialization. Preclinical trials involve testing in animals and cell cultures to ensure safety before human testing begins. Phase 1 trials assess safety and pharmacokinetics, while phase 2 trials determine the appropriate dosage. Phase 3 trials involve large-scale testing to obtain statistically significant outcomes for regulatory approval. Dr Muehler emphasized the importance of continuous clinical development, even after drug approval, to monitor for rare side effects and test in different populations. Clinical trials at Immunic are organized by medical and clinical operations teams and executed with the help of contract research organisations (CROs) to manage the trials across various countries. Dr Muehler highlighted the challenges in clinical trials, such as patient recruitment and the need for effective planning and communication with key opinion leaders and investigators. He shared that staying in close contact with investigators through meetings, site visits, and newsletters helps in efficient trial execution and patient enrolment. Immunic's approach has been successful in rapidly enrolling patients for trials, particularly in multiple sclerosis studies, he added. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 20, 2024 10:00 AM Eastern Daylight Time

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Neural Therapeutics - How do we prevent people getting addicted to opioids?

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell is answering some of the questions raised by Scientific Advisor Professor David Nutt's presentation on the potentially revolutionary untapped effects of psychedelic medicine. Today's questions asks: "The opioid crisis has touched every sector of society and shows no sign of stopping. How do we prevent more people from becoming addicted?" He emphasised that contrary to common concerns, the substances developed by the company have not shown addictive properties in clinical trials. Campbell highlighted that there is no evidence of withdrawal symptoms in patients. Moreover, ongoing scientific work supports the effectiveness of these substances in treating individuals with substance use disorders. The presentation focused on what Professor Nutt describes as the utility of psychedelic compounds and their potential to transform the treatment of mental illness. To watch the full presentation, click here: https://www.proactiveinvestors.co.uk/companies/news/1035785/professor-david-nutt-presents-his-insights-into-psychedelic-medicine-neural-therapeutics-1035785.html 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 United States +1 347-449-0879 action@proactiveinvestors.com

May 20, 2024 09:00 AM Eastern Daylight Time

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News Release

4 Stocks to Watch in the Booming Regenerative Medicine Market

BSEM, ZBH, SNN, MDXG

Regenerative medicine is revolutionizing healthcare. It encompasses a range of cutting-edge therapies aimed at repairing or replacing damaged tissues and organs, offering tangible solutions rather than mere symptom management. With a global market projected to surge from USD 29.42 billion in 2023 to an estimated USD 154.05 billion by 2033, regenerative medicine presents significant investment opportunities. This burgeoning field focuses on utilizing tissue engineering, cellular therapies, and medical devices to harness the body's natural healing processes, paving the way for unprecedented medical advancements. By addressing the root causes of ailments and enabling the regeneration of tissues and organs, regenerative medicine holds immense promise for transforming patient outcomes and reshaping the healthcare landscape. Investors should pay close attention to the developments in regenerative medicine, as they represent not only a paradigm shift in medical treatment but also a lucrative avenue for growth. Here are four companies in the market segment for your watchlist. SNN Smith+Nephew (NYSE: SNN) is a prominent medical technology company specializing in the repair, regeneration, and replacement of soft and hard tissue. With a focus on innovative solutions, Smith+Nephew is positioned as a key player in the regenerative therapy segment. In its recent trading update for the first quarter ended March 30, 2024, Smith+Nephew reported a 2.9% increase in revenue, reaching $1,386 million. This growth highlights the company's resilience and market presence. It is driven by strong performance in orthopaedics, sports medicine, and ENT. Orthopaedics revenue saw a 4.4% increase on an underlying basis, with notable growth in key segments such as hip and knee implants outside the US. Similarly, strong performance in sports medicine joint repair and the growth of the REGENETEN product line drove an underlying 5.5% increase in revenue for sports medicine and ENT. Despite some softness in Advanced Wound Management, Smith+Nephew maintains its full-year 2024 guidance, expecting underlying revenue growth in the range of 5.0% to 6.0%. This guidance reflects the company's confidence in its ability to capitalize on market opportunities and drive sustainable growth. Furthermore, a recent randomized controlled trial (RCT) validated Smith+Nephew's REGENETEN Bioinductive Implant by showing a noteworthy 68% decrease in full-thickness rotator cuff re-tear rates. With over 100,000 procedures completed globally since its introduction, the REGENETEN Bioinductive Implant is poised to contribute significantly to Smith+Nephew's growth in the regenerative therapy segment. As investors seek potential opportunities in the regenerative therapy sector, Smith+Nephew (NYSE: SNN) stands out as a company with innovative solutions and strong growth prospects, making it a stock worth considering. Major global medical technology provider Zimmer Biomet Holdings, Inc. (NYSE: ZBH) continues to demonstrate robust financial performance, reporting impressive first-quarter results. The company, headquartered in Warsaw, Indiana, posted a net income of $172.4 million for the quarter, translating to earnings of 84 cents per share. After adjusting for amortization costs and restructuring expenses, earnings stood at $1.94 per share, surpassing expectations set by Wall Street analysts. In terms of revenue, Zimmer Biomet exceeded forecasts, generating $1.89 billion in revenue for the period. This figure outpaced the expectations of analysts surveyed by Zacks Investment Research, who had projected revenue of $1.87 billion. These results underscore the company's strong market position and its ability to deliver value to shareholders. Last year, in 2023, Zimmer Biomet Holdings Inc. agreed to acquire Embody Inc. for $155 million at closing, with an additional $120 million in contingent milestone payments over the next three years. The deal includes Embody’s entire portfolio of collagen-based regenerative solutions for soft tissue injuries. This strategic move further solidifies Zimmer Biomet's presence in the regenerative medicine sector. Autologous cellular therapies are at the forefront of regenerative medicine. Such treatment options include blood and bone marrow aspirates and concentrations. Zimmer Biomet offers Platelet-Rich Plasma (PRP) products to produce PRP, which can be mixed with autograft or allograft materials. Their BioCUE Blood and Bone Marrow Aspirate (bBMA) Concentration System and Plasmax Plasma Concentration System are notable contributions to this field. Moreover, Zimmer Biomet's cartilage repair solutions can address osteochondral deficiencies in multiple anatomic locations. These solutions provide early interventions that can limit the need for further surgical intervention and potentially divert the progression of these lesions. The philosophy defining Zimmer Biomet's hard tissue products is based on the complex processes involved in tissue repair. Their extensive portfolio includes matrix/scaffold, signaling proteins, and tissue-forming cells that work together to form new tissue, particularly bone. This approach acknowledges the limitations of traditional autograft procedures and offers innovative synthetic bone graft substitutes to overcome these challenges. In addition to their involvement in hard tissue products, Zimmer Biomet offers soft tissue management products suitable for various practices, including orthopedics, plastic surgery, and general surgery. This comprehensive portfolio underscores Zimmer Biomet's commitment to advancing regenerative medicine and highlights the company's recognition of the potential future in this area. Moving forward, Zimmer Biomet's continued focus on innovation and strategic acquisitions positions it as a key player in the evolving landscape of regenerative medicine. With a strong foundation in orthopedic devices and an expanding portfolio in regenerative solutions, Zimmer Biomet is well-positioned to drive growth and deliver value to investors in the years to come. MDXG MiMedx Group, Inc. (NASDAQ: MDXG ) stands as a pioneer and leader in the regenerative medicine sector, dedicated to helping humans heal. With over a decade of experience in managing chronic and hard-to-heal wounds, MiMedx offers a leading portfolio of products tailored for applications in wound care, burns, and surgical sectors of healthcare. The company's vision is to emerge as the foremost global provider of healing solutions through relentless innovation aimed at restoring quality of life. MiMedx specializes in developing and distributing placental tissue allografts across various healthcare sectors. Leveraging its patented and proprietary PURION process, MiMedx processes human placental tissues to produce allografts that retain the tissue's natural biological properties and regulatory proteins. This processing method, which combines aseptic techniques with terminal sterilization, ensures the preservation of the tissue's integrity and efficacy. In the first quarter of 2024, MiMedx achieved significant milestones, demonstrating its continued growth and success. With net sales reaching $85 million, reflecting an impressive 18% growth over the prior year period, the company showcased its strong market presence and growing demand for its products. Additionally, MiMedx reported a GAAP net income from continuing operations of $9 million with an adjusted EBITDA margin of 22%, highlighting its solid financial performance and operational efficiency. Furthermore, MiMedx expanded its product portfolio through a distribution agreement with Regenity Biosciences, introducing a 510(k)-cleared collagen particulate xenograft product set to launch later in the year. This move aligns with MiMedx's commitment to enhancing its offerings and meeting the evolving needs of its customers in the wound and surgical markets. Under the leadership of Joseph H. Capper, MiMedx's Chief Executive Officer, the company continues to demonstrate clinical strength, commercial effectiveness, and disciplined expense management, positioning itself for sustained growth and long-term success. With a focus on relentless innovation and diversification of its portfolio, MiMedx remains poised to deliver innovative healing solutions and drive shareholder value in the dynamic healthcare landscape. For investors with a greater appetite for risk, BioStem Technologies Inc. (OTC: BSEM) represents a compelling opportunity. BSEM is focused on developing, manufacturing, and commercializing placental-derived biologics for regenerative therapies. Its proprietary BioRetain processing method is central to its innovation, preserving crucial growth factors and tissue structure, which differentiates its products in the advanced wound care market. In the first quarter of 2024, BSEM reported revenue of $41.9 million, a significant increase from $0.6 million in the same period the previous year. This growth is primarily driven by the market acceptance of AmnioWrap2, a placental-derived allograft for various wound applications, according to CEO Jason Matuszewski. The company's gross margin was 95%, up from 82% in the first quarter of 2023, reflecting the impact of increased sales and an agreement with Venture Medical. Additionally, BioStem achieved net income for the first time in its history, marking a notable milestone. BSEM has also enhanced its operational capabilities. The company has engaged McCoy Clinical Consulting to lead pivotal clinical trials for Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) treatments. Moreover, BioStem completed a comprehensive two-year audit, a step towards listing on a national stock exchange, which enhances financial transparency and governance. A significant development for BioStem is the United States Patent and Trademark Office’s (USPTO) prioritized examination of its patent for the BioRetain processing technology. This patent is essential for protecting BioStem’s method of processing human amniotic tissue, a key differentiator in the regenerative medicine market. The company's intellectual property portfolio supports its commitment to innovation and its potential to impact the wound care market, which is projected to grow steadily. BioStem has expanded its product offerings and market reach with products like AmnioWrap2, VENDAJE, and VENDAJE AC, processed at its FDA-registered and AATB-accredited facility in Pompano Beach, Florida. These products have gained market traction, supported by BioStem’s quality management system and adherence to current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP). Operational highlights include acquiring assets from Auxocell Laboratories, launching AmnioWrap2 nationwide with Venture Medical LLC, and securing commercialization agreements for Avenova Allograft with NovaBay. The company’s products have also been listed with the U.S. Department of Defense and Veterans Administration, broadening its market presence. On May 15, Zachs Small Cap Research published a comprehensive research report on BioStem Technologies Inc. (OTC: BSEM) highlighting their recent financial results and issuing a valuation of 23.25 per share. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained by BioStem Technologies to assist in the production and distribution of this content. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details Mark McKelvie +1 585-301-7700 Mark@RazorPitch.com Company Website http://razorpitch.com

May 20, 2024 06:00 AM Eastern Daylight Time

Immunic chief medical officer discusses promising treatments to mark World IBD Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses Inflammatory Bowel Disease (IBD) with Proactive's Stephen Gunnion to mark World IBD Day on May 19. Muehler explained that IBD encompasses Crohn's disease and ulcerative colitis, characterised by an immune response triggered by the interaction between gut bacteria and the immune system, leading to bowel wall damage and ulcerations. This condition affects 1-2% of the population, presenting significant social challenges due to symptoms like diarrhoea and abdominal pain, which can limit social and professional activities. Currently, IBD is managed with immunosuppressive drugs, which, while effective, increase susceptibility to infections and other autoimmune diseases and often show immunosuppression. Dr Muehler highlighted the need for treatments that do not suppress the immune system. Immunic Inc. has been exploring new therapies, including a drug that strengthens the bowel barrier. A recent phase two trial with Vidofludimus calcium (IMU-838) in ulcerative colitis showed promising results in maintaining remission. This drug, primarily tested in multiple sclerosis, is part of a class not previously tested in large IBD trials. Another promising drug, IMU-856, aims to regenerate the bowel barrier, preventing harmful interactions between gut bacteria and the immune system without immunosuppression. This drug has shown positive results in animal experiments as well as in healthy volunteers and celiac disease trials. Immunic currently evaluates potential testing of IMU-856 in IBD. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 17, 2024 02:35 PM Eastern Daylight Time

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Tackling Childhood Peanut Allergies

YourUpdateTV

Right now, more children in the U.S. are living with peanut allergy than ever before, and approximately 75% will not outgrow their allergy. Recently, Pediatric Allergist, Dr. Douglas Mack, and Sarah Korieshi, the Mother of a peanut allergic child, participated in a nationwide satellite media tour to discuss the impact on children and innovative new treatment options that can help. A video accompanying this announcement is available at: https://youtu.be/5uKicnsGHv8 The repercussions of this condition are profound, extending beyond mere dietary restrictions to impacting a child's daily life, social interactions, and overall well-being. The constant fear of accidental exposure and the potential for severe allergic reactions can also be extremely difficult for families to navigate. The increase in prevalence over the past 20 years has driven a growing need for effective treatment options to manage the condition. For doctors, that means treatments that reduces the likelihood of an allergic reaction in the case of accidental exposure, and treatments that work within the lifestyle of the child and family. The good news is that recent years have brought about a spate of new innovations in the allergy space. For example, there is currently an ongoing clinical trial evaluating Viaskin TM Peanut, a patch containing the equivalent of one one-thousandth of one peanut kernel. The patch is applied each day to a child’s back in order to build up a tolerance to peanut protein, making it less likely that a child will have a reaction after an accidental exposure. For parents, a treatment like this would be life-changing, as a non-invasive option – something that can be incorporated into our busy lives, without any restrictions to regular activities. Having access to a treatment option that allows children and parents to participate in typical activities for a child, such as birthday parties, sports activities, attending camp, or even school, would give parents peace of mind and children the care-free life they deserve. For more information, visit vitesseallergystudy.com About Dr. Douglas Mack Dr. Mack is co-author of clinical guidelines on the prevention of allergy, oral immunotherapy and anaphylaxis and focuses on oral immunotherapy for food at Halton Pediatric Allergy clinic. Dr. Douglas Mack has been a pediatric allergy, asthma, and immunology specialist for over 10 years. Dr. Mack is an assistant clinical professor in the Department of Pediatrics at McMaster University and is an affiliate of Sick Kids. He sits on the board of directors at the Canadian Society of Allergy and Clinical Immunology. He is co-author of clinical guidelines on the prevention of allergy, oral immunotherapy, and anaphylaxis. Dr. Mack is co-founder of Halton Pediatric Allergy clinic where his focus is on oral immunotherapy for food. About Sarah Korieshi Sarah learned that her daughter Zara had a deadly peanut allergy when she was just 9 months old. The first thing she thought was, not only how life-threatening eating a food can be, but also living with the constant fear of what may happen every time she eats. There has always been constant fear with how unpredictable a reaction can be, and the anxiety that comes with solely relying on avoidance really takes a toll. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

May 17, 2024 10:09 AM Eastern Daylight Time

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