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BioRestorative Therapies (NASDAQ: BRTX) Is Targeting The Global Obesity Epidemic With Its Recent IP Portfolio Expansion

BioRestorative Therapies, Inc.

By Julian Richard, Benzinga BioRestorative Therapies Inc (NASDAQ: BRTX) is expanding its ThermoStem® intellectual property portfolio for treatments targeting obesity, diabetes and other indications related to metabolic syndrome with another patent notice of allowance from the United States Patent Office, adding to its already 19 issued patents under the ThermoStem® patent family. BioRestorative’s ThermoStem® program is a novel cell-based therapy program using cells that have metabolic activity, that once transplanted may be able to regulate the bodies metabolic homeostasis (balance) and potentially induce weight loss and a better metabolic state. Metabolic syndrome is a cluster of conditions, such as obesity often times resulting in elevated cholesterol (fat) and glucose levels in the blood, these conditions increase the risk of developing type 2 diabetes, heart disease and stroke. Pioneering research conducted by Biorestorative Therapies demonstrated that brown tissue burns rather than stores energy. This work was published in Stem cells and was performed in a collaboration with the University of Utah. Increased levels of brown tissue support weight loss by increasing metabolism and reducing glucose and cholesterol in the blood. Thus, increasing brown fat levels and activity may be a powerful way to treat metabolic syndrome's significant mortality and morbidity. The ThermoStem® program is unique in that it pioneers the use of cell-based therapy to treat a global unmet medical need. The obesity and metabolic syndrome management space is the subject of intense clinical development and interest in the medical community. ThermoStem® will provide physicians with a therapeutic alternative to drugs with a different mechanism of action currently on the market. with Altimmune (NASDAQ: ALT), Eli Lilly Co (NYSE: LLY) and Pfizer Inc (NYSE: PFE) looking to emulate the success of Semaglutide, marketed by Novo Nordisk A/S (NYSE: NVO) for the treatment of obesity and type 2 diabetes. Semaglutide was FDA-approved in 2021 for “chronic weight management” and was the first drug approved for this indication since 2014. Because ThermoStem® is a biologic rather than a synthetic drug, it might be a safer alternative to drugs currently under development that have demonstrated safety issues, such as Altimmunes (NASDAQ: ALT) weight loss drug that demonstrated gastrointestinal side effects when used. Obesity: A Global Epidemic Type 1 and type 2 diabetes are two distinct forms of the same disease. Type 1 is an autoimmune disease, whereas type 2 is linked to lifestyle factors such as poor diet and lack of exercise resulting in obesity. Type 2 diabetes is caused by excess weight, poor diet and lack of exercise, leading to too much glucose (sugar) in the bloodstream. Cells in the body cannot respond as they would normally by removing glucose from the blood, a condition called insulin resistance. Type 2 diabetes can often be managed through diet and lifestyle changes such as eating a balanced diet, exercising regularly and maintaining a healthy weight. However, some people with type 2 diabetes may also need medication or insulin injections to manage their condition. Regardless of the type of diabetes, increased blood sugar can cause diseases of the heart, eyes and kidneys and may result in infection and amputation of the feet. The health economic burden of obesity and type 2 diabetes is profound. According to the Centers for Disease Control and Prevention (CDC), over 37 million Americans have diabetes (about 1 in 10), with up to 95% having type 2 diabetes. Type 2 diabetes has historically been considered a disease of adults; however, given the current obesity epidemic, it is becoming more common in children, adolescents and younger adults. By 2030, over one billion individuals will be obese, with 1 in 7 men and 1 in 5 women living with the condition. The World Health Organization has designated obesity as a global epidemic. The total annual cost of diabetes in the United States exceeds $327 billion. This includes direct medical costs, such as hospitalizations and medications, and indirect costs, from lost productivity due to illness or premature death. The burden of obesity and type 2 diabetes is not limited to economic factors alone. The impact of these conditions on the quality of life for patients and carers can be immense. People living with obesity and diabetes are at greater risk for physical, mental, social and emotional difficulties stemming from their condition. Mental health disorders such as anxiety and depression are common among people living with these conditions, partly due to the discrimination they can experience. Physical disability is also an issue for many people living with these conditions. The emotional toll of living with a chronic illness can be immense, leading to feelings of isolation, fear and frustration. ThermoStem® could potentially help with this burden through its novel approach. The novelty of the ThermoStem® technology was acknowledged by the United States Patent Office’s The Notice of Allowance was issued on February 24th of 2023. By expanding the ThermoStem® patent family with another issued patent, BioRestorative is positioned to further strengthen and secure its novel cell-based approach to treat obesity Visit https://www.biorestorative.com for more information on the company and its product candidates. This article was originally published on Benzinga. BioRestorative Therapies was founded by scientists and researchers committed to developing stem cell therapies to address unmet needs in patients with highly prevalent conditions.Our advances in stem cell biology and delivery protocols harbor great promise in conditioning our bodies’ own regenerative potential to treat major diseases more effectively than current interventions.Today, BioRestorative is actively developing programs that aim to dramatically increase quality of care for both (i) chronic back pain caused by disc degeneration, as well as (ii) metabolic disorders including obesity and diabetes. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Investor Relations ir@biorestorative.com Company Website https://www.biorestorative.com/

March 31, 2023 08:30 AM Eastern Daylight Time

Monogram Makes History with Fully Remote Simulated Robotic Surgery

Monogram Orthopedics

Monogram Orthopaedics Inc. is pleased to announce the successful completion of the first fully remote simulated robotic surgery in orthopedic history. On Tuesday, March 7th, 2023, at 2 PM Eastern, Douglas Unis, MD of the Icahn School of Medicine at Mount Sinai in New York City, successfully completed the world's first fully remote total knee arthroplasty (TKA) procedure on a cadaver, controlling the Austin-based robot from New York City in real-time via the systems user-operated foot pedal. The event was live telecast. “This was an incredible achievement for orthopedic robotics and medicine,” said founder Dr. Unis. “Despite being over 1,700 miles away, the real-time system was highly responsive with minimal latency. The applications for a robust system with these capabilities are tremendous. No system on the market today is capable of doing what Monogram just demonstrated.” With the help of state-of-the-art robotic technology, the navigated mBôs prototype has demonstrated the possibilities for the next generation of surgical robotics. A replay of the event is available here. “Our mission is to advance the standard of care in surgical robotics and orthopedics, “ said Ben Sexson, CEO. “I think we demonstrated that today with this historical demo. The achievement is a testament to our team's remarkable dedication and commitment.” Monogram recently announced it had initiated its final financing round as a private company before its planned listing on Nasdaq. Investors can purchase directly on the Company’s website. The company has applied to list its shares on Nasdaq. Once approved, Monogram will trade under the ticker symbol "MGRM." For more information on how to purchase shares, visit www.monogramorthopedics.com. About Monogram Orthopaedics Inc. Monogram Orthopaedics is a medical technology company commercializing robotics and implants for the orthopedic market. The Company is based in Austin, Texas. Monogram Orthopedics is changing the way orthopedic surgery is done. Our system combines personalized knee implants with precision robotic surgical assistants, giving patients a better-fitting knee replacement with minimally invasive surgery. 100,000 knee replacements failing each year in a $19.4B market represents an enormous opportunity for us. This release may include ‘’forward-looking statements.‘’ To the extent that the information presented in this presentation discusses financial projections, information, or expectations about Monogram Orthopedics Inc.’s business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as ‘’should,‘’ ‘’may,‘’ ‘’intends,‘’ ‘’anticipates,‘’ ‘’believes,‘’ ‘’estimates,‘’ ‘’projects,‘’ ‘’forecasts,‘’ ‘’expects,‘’ ‘’plans,‘’ and ‘’proposes.‘’Although Monogram Orthopedics Inc. believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering statement filed with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained, and Monogram Orthopedics Inc. does not undertake any duty to update any forward-looking statements except as may be required by law.The offering will be made only by means of an offering circular. An offering statement on Form 1-A relating to these securities has been filed with the U.S. Securities and Exchange Commission and has become qualified. The securities offered by Monogram are highly speculative. Investing in shares of Monogram involves significant risks. The investment is suitable only for persons who can afford to lose their entire investment. Furthermore, investors must understand that such investment could be illiquid for an indefinite period of time. No public market currently exists for the securities, and if a public market develops following the offering, it may not continue.Monogram intends to list its securities on a national exchange and doing so entails significant ongoing corporate obligations including but not limited to disclosure, filing and notification requirements, as well compliance with applicable continued quantitative and qualitative listing standards. For additional information on Monogram, the offering and any other related topics, please review the Form 1-A offering circular that can be found at the following location EDGAR Entity Landing Page. Additional information concerning Risk Factors related to the offering, including those related to the business, government regulations, intellectual property and the offering in general, can be found in the risk factor section of the Form 1-A offering circular. Contact Details Monogram Orthopaedics Loreana David +1 512-790-5151 info@monogramorthopedics.com

March 30, 2023 04:24 PM Eastern Daylight Time

Premier Biomedical Inc. (OTC: BIEI), Welcomes Officers, Directors and Key Advisors

Premier Biomedical Inc

McapMediaWire -- Premier Biomedical Inc., now known as Premier Graphene, Inc. (OTC: BIEI ), has relocated its headquarters to Imperial Valley, CA. CEO Ivan Mendez welcomes its new officers, directors, and other significant participants. As Vice President, Noe Gallego will spearhead our Mexico hemp procurement operations. Mr. Gallego shared the following, “I am excited to be at the forefront of a rapidly growing industry, with a talented group of persons involved in Premier Graphene, Inc. (Premier). Premier is uniquely poised to revolutionize a variety of industrial sectors from health and wellness to aerospace and construction. With the aid of its counsel in Mexico, Premier Graphene Inc will permit low-cost and robust growing operations to supply high-quality hemp as the principal raw material component for producing the highest-quality graphene that is eco-friendly. Perhaps ironically, it will also inevitably be at a more accessible cost. Indeed, it will be particularly well-suited for Premier’s wide range of products. Perhaps equally important, the environment in Mexico permits 3 Growth cycles per year for this type of industrial hemp, which is the highest quality and best-suited for high-grade graphene production.” Chief of Legal Operations in Mexico and Latin America, Ana Erika Santana, Esq., presently is assisting the federal government of Mexico to codify cannabis and hemp laws and to enact appropriate regulations consistent with such initiatives. Ms. Santana specializes in compliance within both the corporate and government sectors. Ms. Santana added, “To have a successful business, we must have full compliance and cooperation among governmental bodies. I will also ensure conformity with social responsibility which is particularly important within this sector. My strong connections with the Mexican government prompt my participation with Premier Graphene and create my optimism for its future.” Dr. George Stantchev, will serve as a scientific consultant to Premier. Dr. Stantchev is the owner of four European companies that have a presence in North America. The first company, AEMC Technologies, is principally focused on thermal night vision units for military and commercial use. It also engages in product and business management consulting for medical imaging, defense imaging, consumer, automotive, industrial computing, and wireless communications. Next is COMERG. It employs top-notch engineering for the development of medicinal grade extracts and AG technology specialized equipment and machinery. Dr. Stantchev is also the founder of DIAMAGNETIX, a tech innovation company, specializing in improving key processes in the development of Bio and Energy in a nano-material state. His last company, Pure 5 Extractions Systems, is a leading innovative botanical extraction company, with a specific focus on hemp and cannabis. Dr. Stantchev has worked on product development and manufacturing projects with Fortune 500 companies. Ivan Mendez added that “I have had the great pleasure of knowing and working with George for 5 years, in the Cannabis medicinal use field, George will be able to help us with Worldwide resource allocation and client-oriented multi-country product development and manufacturing. I find him to be a great scientist and a leader in the cannabis and hemp extraction business worldwide. He has a brilliant mind and is willing to help when he can.” Dr. Richard Goulding, Chief Medical Officer, will be pursuing the development of medical applications for graphene. This includes unique and extremely efficacious applications for medical instrumentation. Dr. Goulding stated that “my colleagues will be assisting me in developing applications for medical research and development utilizing the unique prospect of graphene involved in fluid filtration processes.” CFO and Human Resources officer, Yvonne Gallego stated, “I am excited about the potential of this rapidly growing industry and the opportunities it lends to financial growth, quality products, and innovation. I am enthusiastic about leading a business that promotes sustainability and environmental stewardship through the cultivation and use of this versatile crop to be employed in our graphene production.” “I believe Mrs. Gallego will be a valuable asset to our company just as she was at HGI Pharma Inc.” states CEO Ivan Mendez. Josh Rockwell, VP of Pulp and Paper Division. “I am excited to join Premier Graphene Inc. as VP of the Pulp and Paper Division. I am a chemical engineer from the University of New Hampshire with 25 years of innovating in the pulp and paper industry through continuous improvement. Hemp will revolutionize the way paper and other vital materials are made. I am proud to join this talented team”. “I am confident Josh’s role in Premier Graphene Inc. His vast experience will prove invaluable to our path forward” added CEO Ivan Mendez. Chief Operating Officer, Mark Kingston, will oversee the day-to-day operations and some of the product development. He will interface with Biographene Technology, 10% owned by Premier, to assure a sufficient quantity of high-grade graphene manufacturing. Mr. Kingston added, “As the Chief Operating Officer of US Hemp Hurd and founder of Pyrotech US Inc., I bring a wealth of experience in managing and minimizing operational risks, ensuring regulatory compliance, and building relationships with stakeholders, customers, suppliers, and partners”. Leveraging his industrial engineering background, Mr. Kingston will drive key innovation and enhance efficiency to ensure that Premier remains at the forefront of R&D, market awareness, and delivery of commercial products and systems. “We are confident that Mark's contributions will play a crucial role in the success of our organization,” says senior consultant Pedro “Pete” Mendez. Pedro “Pete” Mendez, senior consultant to the Board, industrial hemp and cannabis researcher, and entrepreneur, specializing in acquisitions and cannabis products. As a former project manager for HGI Pharma Inc., Mr. Mendez stated: “I believe we will become the dominant force in quality graphene production (for all uses) in North America. We have assembled a unique team. We are fostering innovative technology, manufacturing, and creating a new supply chain that we can control, we will be disrupting the mined graphite market”. CEO Ivan Mendez states: “We are still in the process of interviewing two candidates for Chief Technology officer. We will be providing that information and some very exciting updates as they occur. See below links concerning the above-identified persons and associated entities: http://www.aemctech.com www.Irarm.com http://www.pure5extraction.com/ http://www.comerg.com https://www.linkedin.com/in/stantchev https://www.linkedin.com/in/yvonne-mendez-gallego-psy-m-bsb-8747a812 https://www.linkedin.com/in/erikasantanaabogada https://www.linkedin.com/in/joshuaarockwell https://www.linkedin.com/in/ushemphurd https://ushemphurd.com/ https://uspyrolyzer.com/ https://www.linkedin.com/in/pedro-mendez-a504741ba To get the latest news on the exciting developments from Premier Biomedical Inc. (OTC: BIEI), now known as Premier Graphene, Inc., subscribe by submitting to: https://premiergrapheneinc.com/contact/ For more information, please contact us at: info@premiergrapheneinc.com Website (work in process): https://premiergrapheneinc.com Twitter: @PremierBiomedic https://twitter.com/PremierBiomedic About Premier Graphene, Inc. (OTC: BIEI ), engaged in a holding company reorganization so that the parent company, renamed from “Premier Biomedical Inc.”, has almost no convertible debentures (less than $20,000) outstanding. As a result, the successor issuer public company, Premier Graphene, Inc., has nearly no debt. The predecessor issuer’s debt remains in the original company, now a subsidiary of the publicly traded company. The Company is traded on the OTC Market, in full compliance with OTC Market reporting requirements. Premier Graphene, Inc. is in the process of a single corporate action – changing its name with FINRA and thus OTC Markets. Its articles of incorporation prohibit a reverse split. It is involved in the development of sophisticated products utilizing the unique characteristics of graphene, partnering with various related corporations and unrelated corporations. Safe Harbor Notice Certain statements contained herein are “forward-looking statements” (as defined in the Private Securities Litigation Reform Act of 1995). The Company’ cautions our readers that statements, and assumptions made in this news release constitute forward-looking statements and makes no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time the statements are made. These statements may address issues that involve significant risks, uncertainties and associated estimates made by management. Actual results could differ materially from current projections or implied results. Premier Graphene, Inc. (OTC: BIEI ), whose name is being changed from Premier Biomedical Inc., undertakes no obligation to revise these statements following the date of this news release. Contact Details Premier Graphene, Inc. info@premiergrapheneinc.com

March 30, 2023 09:00 AM Eastern Daylight Time

Odyssey Health, Inc. Preparing for a Phase II Pharmaceutical Concussion Treatment

Odyssey Group Intl Inc.

McapMediaWire -- Odyssey Health, Inc. (OTC: ODYY ), f/k/a Odyssey Group International, Inc., a company focused on creating unique, life-enhancing medical products, is developing a novel neuropharmaceutical treatment for mild Traumatic Brain Injury (mTBI) also known as a concussion. Recently, the world’s leading research agency, the National Institutes of Health (NIH), acknowledged that Chronic Traumatic Encephalopathy (CTE) is caused by repetitive head trauma, not uncommon in the field of sports and in our military. Odyssey’s lead drug candidate, ONP-002, is designed for the acute setting using an intranasal neurosteroid that works to simultaneously reduce swelling, inflammation, and oxidative stress. Odyssey has completed a Phase I clinical trial and is now preparing for a Phase II study to determine the safety and efficacy of its drug. The National Football League (NFL) announced an eighteen percent (18%) increase in concussions sustained in the 2022 season compared to 2021, potentially due to the increased sideline concussion protocols. On average the NFL conducts 1.6 sideline concussion evaluations per game. Data from a recently completed study showed that older retired NFL players had an increased rate of neurocognitive decline compared to non-players. Interestingly, a history of concussion where consciousness was lost had the greatest effect on neurocognitive performance in older athletes. The NFL and NCAA continue to deal with legal claims surrounding concussions. Internationally, Australian Rules footballers have recently brought legal action against the league for downplaying the risk of head injury and failing to have proper protocols in place to protect the players. The cost to the league could be as high as $2 million per player. The league recently reversed its stance and now accepts that CTE is caused in part by repetitive head trauma. In the past few years, concussions in elite rugby leagues have hit an all-time high since records kept. Over twenty-two (22) concussions were documented per one thousand (1000) hours of rugby play. In a significant move, the leagues have instituted a 12-day no-play clause if the player is diagnosed with a concussion. “Given the reported incidences cited, Odyssey Health recognizes the urgent need to bring an effective pharmaceutical to market to treat the concussion epidemic. Not only are the therapeutic effects of the drug vital, but there is a need for a field-deliverable and brain-targeted approach to the drug delivery. Our intranasal delivery should optimize the success of the drug when given to our athletes,” commented Michael Redmond, CEO for Odyssey Health, Inc. About Odyssey Health Inc. (formerly Odyssey Group International, Inc.) Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus on life-saving medical solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the Company’s website at www.odysseyhealthinc.com We encourage our shareholders to visit our corporate social media accounts for updates: https://twitter.com/OdysseyHealth1 https://www.facebook.com/odysseyhealthinc https://www.linkedin.com/company/odysseyhealthinc https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q About ONP-002 ONP-002 is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion). In preclinical studies, ONP-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that ONP-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, ONP-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow. Our novel breath-propelled, intranasal brain-drug delivery device is designed with a novel drug dispensing system that creates an effective airflow for depositing concentrated drug deep into the nasal cavity and onto the olfactory region, this could allow for quick and direct diffusion into the brain.. Forward-Looking Statements This news release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete clinical trial, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions. Inquiries: Odyssey Health info@odysseyhealthinc.com Contact Details Odyssey Health info@odysseyhealthinc.com

March 30, 2023 08:30 AM Eastern Daylight Time

BiVictriX Therapeutics to "continue seeking out positive relationships"

BiVictriX Therapeutics PLC

BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) founder and CEO Tiffany Thorn speaks to Proactive after releasing full year results for 2022, a year that she describes as "very good" for the UK-based drug discovery and development company. Thorn reveals what she was most pleased with from the year before turning her focus to her priorities for 2023, highlighting a desire to grow the company's profile and to "continue seeking out positive relationships." Here's more on that story: BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) has said it is focused on three value creation points for its lead asset BVX001, which is being developed to treat acute myeloid leukaemia. In working towards these goals it believes it will attract the attention of potential partners for what could eventually be a blockbuster treatment. It also reckons this work will provide validation for its Bi-Cygni platform, which aims to develop targeted cancer drugs with fewer side effects. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 30, 2023 05:20 AM Eastern Daylight Time

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Poolbeg Pharma "in a very healthy cash position" after first full year of operations

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) CEO Jeremy Skillington speaks to Proactive after publishing final results for 2022 that show that the clinical-stage biotech company finished its first full year of operations with £16.2mln. Skillington describes it as a "very healthy cash position" and summarises his main highlights from the year, before looking ahead to what the market can expect from Poolbeg during the rest of 2023. Here is the earlier story: Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) has said it is working towards its first partnering ‘transaction’ for POLB 001 after a successful period in which it conducted a first human challenge study on its lead asset to assess its potential in severe flu. On its own, this would be a significant achievement. However, the drug developer has been active in broadening its pipeline in 2022 – adding POLB 002 for severe respiratory virus infections and POLB 003 for melioidosis. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 30, 2023 04:08 AM Eastern Daylight Time

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What If There Was A Topical Cream That Treated PTSD Without Side Effects? — Psycheceutical Bioscience, Inc (OTCPK: BWVI) Is Pioneering A Possible Solution

Psycheceutical Bioscience, Inc.

By Faith Ashmore, Benzinga Psycheceutical Bioscience, Inc (OTCPK: BWVI) is a biotechnology company with patented technology that says it aims to revolutionize the psychedelic mental health space and disrupt Big Pharma. The company is developing a topical cream administration of ketamine to allow the drug to directly target the brain. This unique approach could help solve many of the current issues in mental health treatment through a unique approach. 1 in 6 American adults has reported taking a psychiatric drug like antidepressants or sedatives. The most widely prescribed form of antidepressant are selective serotonin reuptake inhibitors (SSRIs) and you’re probably familiar with the household names. Prozac, Zoloft, and Lexapro are all examples of SSRIs and these types of drugs are prescribed for a wide range of mental health and psychiatric conditions like anxiety, depression, PTSD, and eating disorders. While these therapies are generally safe, the side effects can take a considerable toll on patients. Some patients experience insomnia, nausea, skin rashes and decreased sexual desire. Patients have also reported developing a tolerance to SSRIs and needing to rotate to other drugs once the drug has lost its efficacy. However, SSRIs are not the only treatment. In the past few years, there has been a reignited conversation about the therapeutic benefits of psychedelics – especially psilocybin and ketamine – for mental health conditions like PTSD, anxiety, and depression. The increased funding, research, and attention on psychedelics as the next gold rush in mental healthcare has caught the eyes of patients, providers, and investors alike. Wall Street has been investing tens of millions of dollars in companies that show promising therapies. For example, Gilgamesh Pharmaceuticals Inc. and Lusaris Therapeutics Inc. have announced capital raises of around $100 million. The global psychedelic drug market is expected to grow at a compound annual growth rate (CAGR) of 13.3% from 2022 to 2029, and the FDA is expected to approve treatments using MDMA and psilocybin within the next few years. The growing acceptable and governmental endorsements, an increasing prevalence of mental health disorders, and growing awareness of mental health are all contributing to the rise in psychedelic treatments. And for good reason, psychedelics are showing wild success in clinical trials to help patients who have not seen success with other treatments like SSRIs. Speaking on one class of psychedelics, Roland Griffiths, Ph.D - founding director of Johns Hopkins Center for Psychedelic and Consciousness Research - shared, “Psilocybin not only produces significant and immediate effects, it also has a long duration, which suggests that it may be a uniquely useful new treatment for depression. Compared to standard antidepressants, which must be taken for long stretches of time, psilocybin has the potential to enduringly relieve the symptoms of depression with one or two treatments.” However, one of the major challenges of psychedelics is the modules of treatment. The vast majority of studies and products being developed deliver the drugs through oral administration or IVs. Psychedelic therapy is not as simple as taking Zoloft daily at home, which puts a burden on both patients and providers. For example, someone who is licensed to administer psychedelic therapy has to undergo up to 150 hours of instruction and in-person training sessions; the patient has to go to outpatient facilities for treatment and be monitored after receiving treatment. This drives up the cost of treatments like ketamine infusion, which can be between $400 and $2000 per infusion. Another consideration is that intravenous (IV) or oral administration of psychedelic therapy like ketamine, psilocybin, and more have a plethora of side effects. Side effects such as nausea, headaches, dizziness, disorientation and confusion are common with oral and IV ketamine routes of administration. This is primarily because both forms of administration require the body to absorb through the bloodstream and digestive tract to receive positive benefits in the brain and nervous system. Additionally, if the dosage is even slightly high or the body has an adverse reaction, patients can experience unwanted side effects. Ketamine, for example, is known for a specific and scary side effect nicknamed the “k-hole.”. Although it's not a common side effect in clinical settings, the “k-hole” leaves users feeling disassociated from themselves and their surroundings resulting in panic or paranoia. Psycheceutical Bioscience Reports Pioneering A New Psychedelic Drug With No Side Effects And No Clinical Administration Needed Psycheceutical Bioscience is developing a new and unique mode of administration that could revolutionize the psychedelic mental health space. The company is developing a ketamine treatment that is administered as a topical cream at the back of the neck, to allow the drug to directly target the brain and bypass the GI tract and liver. This process is being designed to eliminate the hallucinogenic effects of psychedelic drugs and significantly reduce the toxicity and adverse effects of these compounds. The company’s patented NeuroDirect™ is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea, and dizziness. In other words, the company believes this mode of administration will present no risk of a “k-hole” side effect. The company is beginning clinical trials to prove the technology. The NeuroDirect™ ketamine topical cream could address the unmet need for rapid relief of PTSD symptoms within minutes and is designed to be administered at home instead of a clinical setting, which would greatly lower the cost of care for both insurance companies and patients, and increase access to these life-saving treatments for anyone suffering from mental health disorders or central nervous system diseases. The majority of PTSD patients, unfortunately, cannot rely on one single drug to help manage their condition and oftentimes are on a cocktail of different prescriptions. With the company’s NeuroDirect™ therapy, the company is seeking to make PTSD treatment simple and effective for patients who have been struggling with no simple, safe, and cost-effective treatment available. A peer-reviewed study published by Drug Development & Delivery shared that more than 80% of 100 patients that tried NeuroDirect™ topical ketamine in a pre-clinical study found it effective and no patients experienced psychogenic effects like hallucinations. In fact, patients felt more focused and that their thought processes were clearer, one patient even described the treatment as “[A] truth serum! I became aware of thoughts and emotions I had suppressed which needed to come out”. The results were experienced within 8-10 minutes and lasted 4-6 hours. Psycheceutical Bioscience could be the next innovator in the development of pharmaceutical products for the mental health care space. Esepcially for people who have not found success in other treatments or are higher-risk patients, like children and the elderly, this module of psychedelic treatment might prove to be ideal. Visit www.psycheceutical.com for more information on the company and its product candidates. This article was originally published on Benzinga here. Psycheceutical Bioscience, Inc. is developing cutting-edge technologies to advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and top minds in the psychedelic space, Psycheceutical is on a mission to commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Kaia Roman, VP Strategy and Communications kaia.roman@psycheceutical.com Company Website https://psycheceutical.com/

March 29, 2023 09:00 AM Eastern Daylight Time

There Is No Cure For ALS, But Coya Therapeutics Might Have The Answer According To A New Clinical Study

Coya Therapeutics Inc.

By David Willey, Benzinga Coya Therapeutics (NASDAQ: COYA) has just reported proof of concept data from its trial for COYA 302, a new combination drug for treating amyotrophic lateral sclerosis (ALS). The results for this novel biologic were positive, showing a slowing or even halting of ALS’ progression. There is currently no drug on the market that can halt ALS progression. The global market for ALS treatment was worth $613 million in 2022 and is expected to reach $1.03 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.3% during the forecast period. There is no known cure for ALS, and the increasing awareness of the disease raised by healthcare and advocacy organizations is partly behind the current market growth. Also known as Lou Gehrig’s disease, ALS can either be hereditary or individual. While it is most associated with aging, certain unhealthy environments and lifestyles could also factor in increasing rates of ALS incidence. ALS is a disease that attacks the brain and spinal column, destroying the motor neurons and causing the degeneration of the nervous system. It usually starts at the extremities like the hands or feet, and as it spreads the patient loses control of their muscles, normally dying from respiratory failure within three to five years. Familial or hereditary ALS only accounts for 5-10% of all ALS patients, and the cause of ALS in sporadic patients, up to 95%, is still unknown. Drugs that are currently on the market, such as Radicava (Edaravone) or Amylyx’s Relyvrio, may slow but do not stop the disease. Recent research suggests that perhaps the best way to tackle ALS is through immunomodulatory therapy that targets motor neuron disease by attacking inflammatory and oxidative stress pathways, which are thought to be contributing to neuronal dysfunction. This is Coya Therapeutics’s approach with its biologic, COYA 302. Data Results Suggest COYA 302 Could Be The Answer Through the data that Coya has collected in its proof of concept study, it believes COYA 302 can control or even possibly even prevent ALS decline. COYA 302 is an investigational combination biologic administered subcutaneously, and it is a combination of COYA 301 (low dose IL-2) and CTLA4-Ig fusion protein. The drug’s dual action controls both inflammation and oxidative stress in the blood. It supports the regulatory T-cells (Treg), which control the immune system’s inflammatory response, and downregulates effector cells, proinflammatory cells, and lipid peroxides. Over the clinical trial’s 48-week period, the drug was tested on four patients for safety, tolerability, the function of Tregs, certain biomarkers, and also for preliminary efficacy. At 24 weeks, there was significant Treg enhancement, and at 48 weeks the serum biomarkers for inflammation and oxidative stress were lowered. Throughout the treatment, the patients did not appear to suffer any serious adverse effects. COYA 302’s preliminary efficacy was measured using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), a validated rating tool that monitors the disability progression in ALS patients. The mean (±SD) ALSFRS-R scores were 33.75 ±3.3 at week 24 and 32 ±7.8 at week 48, not statistically different from the ALSFRS-R score at baseline (33.5 ±5.9) before COYA 302 treatment. In other words, the data suggests a significant improvement in the progression of the disease over the 48-week treatment period, validating Coya’s approach with its new biologic. “We believe the results of this initial proof-of-concept study in a small number of ALS patients are encouraging and warrant conducting a larger and controlled industry-sponsored study. ALS continues to be a disease of high unmet need and we are committed to develop COYA 302 as safely and as expeditiously as possible, in compliance with current regulations,” said Adrian Hepner, M.D., Coya’s Chief Medical Officer. “We plan to file an IND with the FDA in the second half of 2023 and initiate a clinical study soon thereafter.” Want to learn more about Coya Therapeutics and what it’s doing to treat ALS? Visit its website. This article was originally published on Benzinga here. About Coya Therapeutics, Inc.Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice Contact Details David S. Snyder David@coyatherapeutics.com Company Website https://coyatherapeutics.com/

March 29, 2023 09:00 AM Eastern Daylight Time

News Release

FREEDOM HOLDINGS ANNOUNCES MANAGEMENT HAS COMPLETED FINANCIAL REPORTS

FREEDOM HLDG INC.

McapMediaWire -- Freedom Holdings, Inc. aka Freedom Acquisition Corp (OTC: FHLD ) (“FHLD” or the "Company”), is pleased to announce that new management has completed the 10Q and 10K filings bringing the company audits and filings current and up to date for fiscal year ending September 30, 2022. John Vivian, CEO stated: “We are now working on the remaining 10Q for period ending 12-31-2022 and once completed will be fully SEC compliant. This will then allow management to work towards the approval of trading status. I am happy to further report that the company is in substantive negotiations with several cannabis companies to acquire and merge under the Freedom umbrella in execution of the Company business plan." "We look forward to bringing new and exciting updates of the furtherance of our efforts in the very near future", concluded Vivian. Press Release Contact: John Vivian CEO Freedom Holdings, Inc. 813-699-4098 Safe Harbor Statement This press release contains statements, which may constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief, or current expectations of the Company, members of its management, and assumptions on which such statements are based. We caution prospective investors that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and that actual results may differ materially from those contemplated by such forward-looking statements. Contact Details Freedom Holdings, Inc. +1 813-699-4098

March 29, 2023 08:30 AM Eastern Daylight Time

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