AMBS is a regenerative medicine company developing new treatments for CNS disorders and regenerative medicine. It has several programs and subsidiaries developing treatments for conditions like Parkinson's disease, burns, cancer, and retinal diseases. Its lead programs include Eltoprazine for Parkinson's disease levodopa-induced dyskinesia through its subsidiary Elto Pharma, and recombinant MANF protein for retinal conditions like retinitis pigmentosa through its subsidiary MANF Therapeutics. AMBS is currently trading at very low prices but has achieved much higher values in the past, and it believes further progress in its clinical programs could increase its valuation.
Vivos Inc. presented a new brachytherapy tool called RadioGel for treating cancers in humans and animals. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel vehicle. It is designed to deliver a high radiation dose directly to tumors while minimizing damage to healthy tissue. The company expects to generate near-term revenue from veterinary applications and international licensing as it pursues FDA approval for multiple human cancer indications starting with skin cancer. Vivos has strong leadership and advisors in place and an intellectual property protected platform technology to become an important new tool for cancer treatment.
Globavir is presenting its corporate strategy to target tropical diseases through accelerated drug development. The presentation highlights GBV006, a late-stage drug candidate for the treatment of dengue fever derived from two FDA-approved drugs. GBV006 has shown potent antiviral activity and 100% survival in animal studies. Globavir also has a pipeline of diagnostic tests and is pursuing partnerships to develop and commercialize its products globally.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Catasys provides an integrated virtual healthcare program called OnTrak that identifies and treats behavioral health conditions like substance abuse and depression. OnTrak uses predictive analytics to identify high-cost patients with behavioral health issues who rarely seek treatment. Patients enroll in a 52-week virtual treatment program with care coaching support. Studies show OnTrak significantly reduces medical costs and healthcare utilization for enrolled members. Catasys contracts with health plans to provide OnTrak and is paid a monthly fee per enrolled member.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
Tiziana Life Sciences provides an update on their clinical pipeline, including completing a study of nasally administered Foralumab in COVID-19 patients that showed positive responses, initiating several phase 2 trials with Foralumab and Milciclib, and executing an agreement with Precision Biosciences to use Foralumab to improve CAR-T cell therapy outcomes for cancer treatment. The company is developing oral and intranasal formulations of antibodies to enable local tissue delivery and reduce costs and side effects compared to IV administration. Milciclib is advancing in clinical trials as a potential treatment for cancers like hepatocellular carcinoma and KRAS-mutated
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
Vivos Inc. presented a new brachytherapy tool called RadioGel for treating cancers in humans and animals. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel vehicle. It is designed to deliver a high radiation dose directly to tumors while minimizing damage to healthy tissue. The company expects to generate near-term revenue from veterinary applications and international licensing as it pursues FDA approval for multiple human cancer indications starting with skin cancer. Vivos has strong leadership and advisors in place and an intellectual property protected platform technology to become an important new tool for cancer treatment.
Globavir is presenting its corporate strategy to target tropical diseases through accelerated drug development. The presentation highlights GBV006, a late-stage drug candidate for the treatment of dengue fever derived from two FDA-approved drugs. GBV006 has shown potent antiviral activity and 100% survival in animal studies. Globavir also has a pipeline of diagnostic tests and is pursuing partnerships to develop and commercialize its products globally.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Catasys provides an integrated virtual healthcare program called OnTrak that identifies and treats behavioral health conditions like substance abuse and depression. OnTrak uses predictive analytics to identify high-cost patients with behavioral health issues who rarely seek treatment. Patients enroll in a 52-week virtual treatment program with care coaching support. Studies show OnTrak significantly reduces medical costs and healthcare utilization for enrolled members. Catasys contracts with health plans to provide OnTrak and is paid a monthly fee per enrolled member.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
Tiziana Life Sciences provides an update on their clinical pipeline, including completing a study of nasally administered Foralumab in COVID-19 patients that showed positive responses, initiating several phase 2 trials with Foralumab and Milciclib, and executing an agreement with Precision Biosciences to use Foralumab to improve CAR-T cell therapy outcomes for cancer treatment. The company is developing oral and intranasal formulations of antibodies to enable local tissue delivery and reduce costs and side effects compared to IV administration. Milciclib is advancing in clinical trials as a potential treatment for cancers like hepatocellular carcinoma and KRAS-mutated
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
One in 8 U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin® in the first year, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin® has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla® has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin® or Kadcyla®.
Immuron Limited is a clinical-stage biopharmaceutical company targeting inflammatory and infectious diseases with oral immunotherapies. It has two lead clinical assets in Phase 2 development for fatty liver disease and C. difficile infection. It also has a registered and revenue-generating Travelan product targeting traveler's diarrhea. The company is listed on the NASDAQ and ASX exchanges and has an experienced management team supported by key opinion leaders. It is well positioned to address significant unmet needs in liver disease and infectious disease markets with blockbuster potential. Near-term milestones include interim data readouts from multiple Phase 2 NASH and pediatric NAFLD trials in 2017-2018.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to
developing and commercializing novel therapeutics to tackle unmet medical needs.
Aptorum's current drug pipeline includes indications in orphan diseases, infectious
diseases, and metabolic diseases. In 2021, the company plans to bring two candidates to
clinical trials. Aptorum’s Smart-ACT™ platform is designed to bring an average of three
drug candidates for orphan diseases to clinical trials every 12-18 months. The company is
now preparing to launch a dietary supplement for women undergoing menopause and
experiencing related symptoms, including osteoporosis. Targeting a global woman’s health
supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to
generate near-term revenue with significant long-term growth potential.
Milestone Scientific Inc. (MLSS) is a biomedical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and instruments for medical and dental applications. Milestone's computer-controlled systems are designed to make injections precise, efficient, virtually painless, and less expensive. Milestone’s proprietary DPS® Dynamic Pressure Sensing technology® platform advances the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, with specific applications for epidural space identification in regional anesthesia procedures.
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
This document provides an overview of G Medical Innovations and its mobile medical devices and monitoring services. It summarizes that G Medical develops FDA-approved mobile devices that collect diagnostic health data and enable remote patient monitoring to improve outcomes and reduce healthcare costs. The company has a growing portfolio of products and services and sees significant market potential to expand direct-to-consumer sales and the number of customers that include insurance providers, hospitals, clinics, and physicians. G Medical aims to capitalize on the large market for remote patient monitoring and digital health solutions to help manage the rising complexity and costs of healthcare.
NE3107 is a small molecule in Phase 3 clinical trials for Alzheimer's disease and Parkinson's disease. It works by inhibiting neuroinflammation and insulin resistance, two key drivers of cognitive decline. A Phase 3 trial for Alzheimer's is underway testing NE3107's ability to slow cognitive decline compared to placebo. Preclinical studies show NE3107 reduces inflammation, enhances insulin sensitivity, and has neuroprotective effects, supporting its potential in neurodegenerative diseases. A Phase 2 trial will assess NE3107's activity and safety when combined with L-dopa for Parkinson's disease.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Biosceptre is developing targeted cancer therapies directed at the nfP2X7 receptor, which is found in many cancer types but not healthy tissue. They have three drug candidates in clinical trials: BIL03s, a systemic antibody; BIL06v, a peptide vaccine; and BIL010t, a topical antibody for skin cancer. Biosceptre seeks to raise £25M for further development and has an experienced leadership team and intellectual property protecting its platform until the early 2030s.
SciSparc is a specialty pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders. The proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system (CNS) to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.
Tiziana Life Sciences presented an overview of their transformational immunotherapy platform enabling alternative routes of administration. Their proprietary technologies allow for oral, nasal, and inhalation delivery of antibodies, which currently require IV administration. They highlighted clinical progress including trials of their lead asset foralumab administered intranasally for progressive MS and COVID-19. Results demonstrated safety and positive clinical responses. Tiziana is also developing other pipeline assets and expanding their management team and scientific advisory board.
This document discusses Ruthigen, Inc., a drug development company focused on developing RUT58-60, a hypochlorous acid-based drug candidate for invasive use. RUT58-60 aims to improve patient outcomes for invasive procedures by reducing post-surgical infections in a more effective way than current standard of care antibiotics. Published studies on Microcyn, another hypochlorous acid-based product, show promise in reducing infection rates for diabetic foot ulcers and coronary artery bypass graft surgery wounds. If successful, RUT58-60 could help hospitals reduce costs by shortening patient stays and lowering readmission rates for post-surgical infections.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Lantern Pharma leverages AI, machine learning and genomic data to transform oncology drug development. Their RADR platform identifies patient subgroups likely to respond to drug candidates to increase success rates. They are developing multiple oncology drug programs including LP-100 for prostate cancer through a precision trial. LP-300 targets never-smoker NSCLC adenocarcinoma based on prior data and biomarker studies. Lantern aims to reduce costs and time through AI-enabled approaches.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
HR Compliance & Insurance Benefit Perspectives: What Employers Should Be Awar...Rea & Associates
Guidelines for employees are constantly changing but it’s important that businesses stay on top of mandates and regulations. What risks should organizations be informed about? Is your organization able to have varied insurance premiums for vaccinated vs. non-vaccinated employees?
Join Rea & Associates and Huntington Insurance for a deep dive into best practices for exposures, insurance perspectives, and vaccine mandates and regulations.
Lantern Pharma leverages AI, machine learning and genomics to rescue and develop targeted cancer therapies. The company's RADR platform contains over 4.6 billion data points covering drug and tumor interactions. Lantern is developing a portfolio of targeted cancer drugs including LP-100, LP-184, LP-300 and novel ADC programs. The company aims to identify patient populations most likely to respond to therapies to streamline drug development and maximize success.
Reviva Pharmaceuticals Holdings Inc is a clinical development pharmaceutical company. It is developing a portfolio of internally discovered therapies that address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases.
In a research report by Berdud, M., Drummond, M. and Towse, A. (2018), a reasonable price for an orphan drug was established based on the proposition that rates of returns from investments in developing orphan drugs should be no greater than the industry average (for all drugs). At the 2018 EuHEA conference held in Maastricht, The Netherlands, 11-14 July, Mikel showed (i) how the reasonable price should be established and (ii) how NICE's cost-effectiveness threshold should be adjusted to ensure a reasonable price for an orphan drug. In slides results are discussed and conclusions showed too.
Author(s) and affiliation(s): Mikel Berdud, PhD (OHE); Prof. Mike Drummond (University of York); Prof. Adrian Towse (OHE)
Conference/meeting: EuHEA 2018
Location: Maastricht, The Netherlands
Date: 12/07/2018
Therapeutic interchange in hemophilia aupdatedRoohee Peerzada
This document summarizes a study comparing the therapeutic interchange of plasma-derived factor VIII (pdFVIII) and recombinant factor VIII (rFVIII) for the treatment of Hemophilia A. The study analyzed the safety, efficacy, and costs of various pdFVIII and rFVIII products. It found that while rFVIII products had a slightly higher risk of inhibitor development, the cost difference between rFVIII and pdFVIII products could amount to over $4 million more for rFVIII over a patient's lifetime. However, both classes of products showed similar efficacy in clinical trials. The study concluded that therapeutic interchange between pdFVIII and rFVIII is a viable option to reduce costs while maintaining patient outcomes for
One in 8 U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin® in the first year, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin® has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla® has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin® or Kadcyla®.
Immuron Limited is a clinical-stage biopharmaceutical company targeting inflammatory and infectious diseases with oral immunotherapies. It has two lead clinical assets in Phase 2 development for fatty liver disease and C. difficile infection. It also has a registered and revenue-generating Travelan product targeting traveler's diarrhea. The company is listed on the NASDAQ and ASX exchanges and has an experienced management team supported by key opinion leaders. It is well positioned to address significant unmet needs in liver disease and infectious disease markets with blockbuster potential. Near-term milestones include interim data readouts from multiple Phase 2 NASH and pediatric NAFLD trials in 2017-2018.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to
developing and commercializing novel therapeutics to tackle unmet medical needs.
Aptorum's current drug pipeline includes indications in orphan diseases, infectious
diseases, and metabolic diseases. In 2021, the company plans to bring two candidates to
clinical trials. Aptorum’s Smart-ACT™ platform is designed to bring an average of three
drug candidates for orphan diseases to clinical trials every 12-18 months. The company is
now preparing to launch a dietary supplement for women undergoing menopause and
experiencing related symptoms, including osteoporosis. Targeting a global woman’s health
supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to
generate near-term revenue with significant long-term growth potential.
Milestone Scientific Inc. (MLSS) is a biomedical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and instruments for medical and dental applications. Milestone's computer-controlled systems are designed to make injections precise, efficient, virtually painless, and less expensive. Milestone’s proprietary DPS® Dynamic Pressure Sensing technology® platform advances the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, with specific applications for epidural space identification in regional anesthesia procedures.
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
This document provides an overview of G Medical Innovations and its mobile medical devices and monitoring services. It summarizes that G Medical develops FDA-approved mobile devices that collect diagnostic health data and enable remote patient monitoring to improve outcomes and reduce healthcare costs. The company has a growing portfolio of products and services and sees significant market potential to expand direct-to-consumer sales and the number of customers that include insurance providers, hospitals, clinics, and physicians. G Medical aims to capitalize on the large market for remote patient monitoring and digital health solutions to help manage the rising complexity and costs of healthcare.
NE3107 is a small molecule in Phase 3 clinical trials for Alzheimer's disease and Parkinson's disease. It works by inhibiting neuroinflammation and insulin resistance, two key drivers of cognitive decline. A Phase 3 trial for Alzheimer's is underway testing NE3107's ability to slow cognitive decline compared to placebo. Preclinical studies show NE3107 reduces inflammation, enhances insulin sensitivity, and has neuroprotective effects, supporting its potential in neurodegenerative diseases. A Phase 2 trial will assess NE3107's activity and safety when combined with L-dopa for Parkinson's disease.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Biosceptre is developing targeted cancer therapies directed at the nfP2X7 receptor, which is found in many cancer types but not healthy tissue. They have three drug candidates in clinical trials: BIL03s, a systemic antibody; BIL06v, a peptide vaccine; and BIL010t, a topical antibody for skin cancer. Biosceptre seeks to raise £25M for further development and has an experienced leadership team and intellectual property protecting its platform until the early 2030s.
SciSparc is a specialty pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders. The proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system (CNS) to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.
Tiziana Life Sciences presented an overview of their transformational immunotherapy platform enabling alternative routes of administration. Their proprietary technologies allow for oral, nasal, and inhalation delivery of antibodies, which currently require IV administration. They highlighted clinical progress including trials of their lead asset foralumab administered intranasally for progressive MS and COVID-19. Results demonstrated safety and positive clinical responses. Tiziana is also developing other pipeline assets and expanding their management team and scientific advisory board.
This document discusses Ruthigen, Inc., a drug development company focused on developing RUT58-60, a hypochlorous acid-based drug candidate for invasive use. RUT58-60 aims to improve patient outcomes for invasive procedures by reducing post-surgical infections in a more effective way than current standard of care antibiotics. Published studies on Microcyn, another hypochlorous acid-based product, show promise in reducing infection rates for diabetic foot ulcers and coronary artery bypass graft surgery wounds. If successful, RUT58-60 could help hospitals reduce costs by shortening patient stays and lowering readmission rates for post-surgical infections.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Lantern Pharma leverages AI, machine learning and genomic data to transform oncology drug development. Their RADR platform identifies patient subgroups likely to respond to drug candidates to increase success rates. They are developing multiple oncology drug programs including LP-100 for prostate cancer through a precision trial. LP-300 targets never-smoker NSCLC adenocarcinoma based on prior data and biomarker studies. Lantern aims to reduce costs and time through AI-enabled approaches.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
HR Compliance & Insurance Benefit Perspectives: What Employers Should Be Awar...Rea & Associates
Guidelines for employees are constantly changing but it’s important that businesses stay on top of mandates and regulations. What risks should organizations be informed about? Is your organization able to have varied insurance premiums for vaccinated vs. non-vaccinated employees?
Join Rea & Associates and Huntington Insurance for a deep dive into best practices for exposures, insurance perspectives, and vaccine mandates and regulations.
Lantern Pharma leverages AI, machine learning and genomics to rescue and develop targeted cancer therapies. The company's RADR platform contains over 4.6 billion data points covering drug and tumor interactions. Lantern is developing a portfolio of targeted cancer drugs including LP-100, LP-184, LP-300 and novel ADC programs. The company aims to identify patient populations most likely to respond to therapies to streamline drug development and maximize success.
Reviva Pharmaceuticals Holdings Inc is a clinical development pharmaceutical company. It is developing a portfolio of internally discovered therapies that address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases.
In a research report by Berdud, M., Drummond, M. and Towse, A. (2018), a reasonable price for an orphan drug was established based on the proposition that rates of returns from investments in developing orphan drugs should be no greater than the industry average (for all drugs). At the 2018 EuHEA conference held in Maastricht, The Netherlands, 11-14 July, Mikel showed (i) how the reasonable price should be established and (ii) how NICE's cost-effectiveness threshold should be adjusted to ensure a reasonable price for an orphan drug. In slides results are discussed and conclusions showed too.
Author(s) and affiliation(s): Mikel Berdud, PhD (OHE); Prof. Mike Drummond (University of York); Prof. Adrian Towse (OHE)
Conference/meeting: EuHEA 2018
Location: Maastricht, The Netherlands
Date: 12/07/2018
Therapeutic interchange in hemophilia aupdatedRoohee Peerzada
This document summarizes a study comparing the therapeutic interchange of plasma-derived factor VIII (pdFVIII) and recombinant factor VIII (rFVIII) for the treatment of Hemophilia A. The study analyzed the safety, efficacy, and costs of various pdFVIII and rFVIII products. It found that while rFVIII products had a slightly higher risk of inhibitor development, the cost difference between rFVIII and pdFVIII products could amount to over $4 million more for rFVIII over a patient's lifetime. However, both classes of products showed similar efficacy in clinical trials. The study concluded that therapeutic interchange between pdFVIII and rFVIII is a viable option to reduce costs while maintaining patient outcomes for
This document discusses a clinical trial evaluating the efficacy of the drug Aricept for the treatment of Alzheimer's disease. It provides details on:
1) The study design which was a 30-week randomized, double-blind, placebo-controlled trial comparing placebo to 5mg or 10mg doses of Aricept.
2) The results which showed a statistically significant improvement in cognitive test scores (ADAS-cog) for both Aricept groups compared to placebo after 24 weeks.
3) That upon stopping Aricept after 24 weeks, cognitive scores returned to placebo levels, indicating the benefits of the drug were temporary and did not change the underlying disease progression.
This document discusses a clinical trial evaluating the efficacy of the drug Aricept for the treatment of Alzheimer's disease. It provides details on:
1) The study design which was a 30-week randomized, double-blind, placebo-controlled trial comparing placebo to 5mg/day or 10mg/day doses of Aricept.
2) The results which showed a statistically significant difference in ADAS-cog scores after 24 weeks between both active drug doses and placebo, indicating improved cognitive performance.
3) After placebo washout, scores returned to placebo levels, suggesting the benefits of Aricept are lost after discontinuing treatment.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
The document discusses an innovative nutritional diagnostic tool called MDflux that allows dietitians and doctors to precisely assess a patient's nutritional state and needs. It found that standard hospital care often results in overfeeding or undernourishment of patients. MDflux provides actionable data to personalize nutrition and support healing. Key learnings included that dietitians are the main stakeholders, there is potential in neonatal care, and a partnership could help scale internationally and obtain regulatory approvals. The total addressable market is estimated at $9 billion annually in the US.
In this webinar, you will learn:
How we approach intervention campaigns: a framework
The science of behavior change and how it can be applied to increase the probability of desired outcomes
How Altarum’s ACE Measure can help predict consumer behaviors and design successful intervention campaigns
Speakers:
Ryan Rossier, Medullan
Chris Duke, Altarum
Josh Klapow, ChipRewards
Canadian Expert Patients in Health Technology Conference
Nov 7 – 8, 2016: Day 2 Appropriate Place in Therapy Allan Miranda (Janssen), John Snowden (Amgen), Dawn Richards (Canadian Arthritis Patient Alliance), Seema Nagpal (Canadian Diabetes Association),
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
E.Gombocz: Changing the Model in Pharma and Healthcare (DILS Keynote 2013-07...Erich Gombocz
Innovations in healthcare delivery and Pharma require re-examination of process models at the foundation of our knowledge discovery and clinical practice. Despite real-time availability of ‘big data’ from ubiquitous sensors, mobile devices, 3D printing of drugs, and a mind shift in data ownership, data integration still remains one of the core challenges to innovation. Increasingly persistent, semantic data integration is gaining recognition for its dynamic data model and formalisms which make it possible to infer from and reason over interconnected contextualized data, creating actionable knowledge faster and at lower cost. While such technical advances underpin the successful strategies to drive positive patient outcomes or accelerate drug design, there are equally profound social changes towards the willingness of patients to share their own data - opening doors to new patient-centric, precision-medicine healthcare models.
Should costs matter in healthcare decision making?- 2015 Policy Prescriptions...Cedric Dark
1. Healthcare costs in the US are very high, totaling $2.7 trillion in 2011 or $8,680 per person. However, costs vary wildly for the same procedures between different hospitals.
2. Costs are continuing to rise rapidly, with insurance premiums and out-of-pocket costs both increasing substantially in recent years. This is contributing to many patients struggling to pay medical bills or declaring bankruptcy.
3. To control costs and improve value, there is a push for greater price transparency, paying providers based on quality and outcomes rather than fee-for-service, and narrow network insurance plans with higher deductibles.
How Pharma Can Use Digital Health to Drive Value | A Medullan WebinarMedullan
With the shift to value, healthcare payers are insisting that pharmaceutical manufacturers deliver real world evidence of their drug’s efficacy before being allowed on formulary. The cost of new specialty treatments has forced companies to bolster and go beyond clinical trial, proving that their drugs improve health outcomes and reduce the cost of care with real world evidence.
So how do pharmaceutical companies gather these data points and what kind of digital tools should they use?
This document discusses mobile health (mHealth) technology and research. It contains the following key points:
1) Former HHS Secretary Kathleen Sebelius called mHealth "the biggest technology breakthrough of our time" to address healthcare challenges. However, most supporting data is in pilot studies and definitive clinical trials are needed.
2) It can take an average of 17 years for clinical research to change the majority of clinical practice. New technologies also require changes to existing healthcare systems and processes.
3) While mHealth shows promise, high quality studies measuring objective clinical outcomes are still needed to demonstrate benefits over current standards of care. Researchers must focus on optimizing interventions and addressing limitations in current evidence.
The document provides an overview of an educational session on outcomes-based contracting between specialty pharmaceutical manufacturers and payers. It begins with four learning objectives, which focus on explaining the benefits of outcomes-based contracting, identifying considerations in designing such contracts, and describing tools for assessing patient response to therapy. It then provides information on continuing education credit for attendees, discloses the presenters' financial relationships, and reviews antitrust guidelines. The presentation aims to educate on the rationale for and experience with outcomes-based contracting programs.
The Health Innovation Network Polypharmacy programme is working with healthcare professionals to address problematic polypharmacy by supporting easier identification of patients at potential risk from harm from multiple medications.
Our evidence-based polypharmacy Action Learning Sets (ALS) are being rolled out across England to support GPs, pharmacists and other healthcare professionals who undertake prescribing or medication reviews to understand the complex issues around stopping inappropriate medicines safely.
To drive and accelerate changes in practice, delegates complete a quality improvement project to address problematic polypharmacy in their workplace. This poster summary, Re-establishing autonomy in elderly frail patients, can be viewed here.
For more information about the polypharmacy programme, please visit https://thehealthinnovationnetwork.co.uk/programmes/medicines/polypharmacy/
The document discusses genome-wide sequencing for diagnosis of rare diseases in Canada. It notes the current unmet clinical need, with specialists taking 3-5 years on average to diagnose rare diseases and 40% of patients receiving more than 3 misdiagnoses. Access to clinical exome sequencing varies across Canada. The goal of the Partnership discussed is to ensure access to clinical genome-wide sequencing as standard of care for Canadians at risk for a serious genetic condition who would benefit from timely diagnosis and intervention. It will include access to sequencing, data governance, a pan-Canadian data ecosystem for sharing to catalyze innovation, engagement of patients/communities and health professionals, and establishment of a rare disease cohort and diagnostic ecosystem to scale data.
Jan 31, 2018 How to Ensure Patient-Centred Pharmacare is Cost-Effective Healthcare A Consultation on Patented Medicine Prices Review Board & Biologic Medicines
This presentation summarizes ACT's regenerative medicine business. ACT is a biotechnology company developing cellular therapies for diseases affecting hundreds of millions. Their leading program is an RPE cell therapy for dry AMD currently in clinical trials. The therapy shows early promise with no safety issues reported. If successful, it could generate billions in revenue given the large patient population. ACT has a strong balance sheet and team to advance its pipeline of stem cell therapies targeting ocular diseases and conditions.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
Similar to Amarantus Bioscience Holdings Presentation (20)
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Docola has developed a healthcare communication platform that utilizes asynchronous telehealth to deliver patient education and support. Their proprietary platform currently has over 55,000 patient users and over 1,100 clinician users. Docola seeks to raise up to $500,000 through a convertible note to fund working capital, research and development, and costs associated with an upcoming IPO.
- INNO Holdings is presenting an IPO investor presentation for an initial public offering on the NASDAQ Capital Market.
- The company manufactures prefabricated steel building components and systems using proprietary technology to reduce construction costs and environmental impact.
- INNO Holdings has four initial product lines - metal studs, prefabricated housing units, modular apartment buildings, and a mobile factory system. It aims to disrupt the construction industry through standardized, sustainable construction methods.
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a biotech company developing immune monitoring and immune modulation platforms. Its AditxtScore platform can provide comprehensive immune profiles to monitor responses to pathogens, vaccines, drugs and transplants. Its Adimune platform aims to modulate the immune system to treat conditions like psoriasis, type 1 diabetes, and increase skin allograft survival. The company is working to develop, operate and commercialize these platforms. It currently generates revenue from immune monitoring tests and expects revenue from licensing deals for immune modulation programs as they advance in clinical trials towards commercialization.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Bienestar Financiero al servicio de su jubilación anticipada
Pago de su 🏡
Estudio de sus hijos
Directamente a tu cuenta bancaria
Con Tesorería Auditoria Jurídica comercial
Administración de carteras
Apalancamiento Financiero
Desarrollo de tu marca personal
Acceso a Desarrollo de varias industrias
Cuentas bancarias
Estructuras Físicas en USA y en América Central
Avalado por Bolcomer
Puesto de Bolsa Comercial
Turismo
Y mucho más
Link de registro
https://business.myinfinity.global/maurod8/
https://therusnetwork.com/
Contacto:
https://goo.su/pzm1fja
UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
2. Forward-Looking Statements
This presentation contains “forward-looking statements” within the meaning of the “safe-harbor”
provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and
unknown risks, uncertainties and other factors that could cause the actual results of the Company to
differ materially from the results expressed or implied by such statements, including changes from
anticipated levels of sales, future international, national or regional economic and competitive
conditions, changes in relationships with customers, access to capital, difficulties in developing and
marketing new products and services, marketing existing products and services, customer acceptance of
existing and new products and services and other factors. Accordingly, although the Company believes
that the expectations reflected in such forward-looking statements are reasonable, there can be no
assurance that such expectations will prove to be correct. The Company has no obligation to update the
forward-looking information contained in this presentation.
2
3. Executive Team
Gerald E. Commissiong: Co-Founder, President & CEO, Director
Co-Founder & Led acquisition of AMBS portfolio via over $40M in capital raised
Stanford University, Management Science & Engineering
Elise Brownell, PhD: Sr. Vice President of Project Management and Operations
Head of New Deal Flow Management, The Angels’ Forum
Head of Project Management at Bayer Biotechnology; Head of Project Management, Aerovance, Inc.
Yale University, PhD in Biology
Curt Scribner, MD MBA: Sr. Vice President of Regulatory Affairs
Sr. VP of Regulatory Affairs at RRD International
Chief Regulatory Officer at Intarcia Therapeutics
Chief Regulatory Consultant at Quintiles
3
5. Elto Pharma, Inc. - Eltoprazine: Pipeline in a Pill
Oral small molecule drug candidate targeting 5HT1a/1b receptors
1. Parkinson’s Disease – Levodopa Induced Dyskinesia (PD-LID, Orphan Drug Designation)
o Addresses primary side effect of standard of care therapy (Levodopa, or L-Dopa)
2. Alzheimer’s Agitation:
o Clinical data package produced by Solvay (Abbvie) in 1990s studies in dementia-related agitation
3. Adult ADHD:
o Non-stimulant, non-scheduled. Acts on attention & hyperactivity/impulsivity scales
Orphan Drug Designation
6. Eltoprazine Lead Indication:
Parkinson’s disease Levodopa Induced Dyskenesia (PD-LID)
• L-Dopa = most effective treatment for motor symptoms of PD
- With disease progression, L-Dopa is taken up by serotonergic (5-HT) pathways in the brain
- 5HT pathways lack feedback mechanisms to control levels of dopamine
- Excessive dopamine buildup causes uncontrolled movements
- PD-LID’s uncontrolled movements are a disabling, unwanted consequence
• PD-LID severely impairs quality of life
• Only available treatment = Gycovri® (amantadine HCl) approved in 2017
- Moderately effective at reducing PD-LID
- Suboptimal response rates due to mechanism of action
7. Eltoprazine Phase 2a PD-LID Trial Data Published in 2015
Phase 2a trial achieved primary endpoint
o Karolinska Institute and Univ. of Lund
o 22 patients (3 dosing arms → middle dose effective)
o Statistically significant CDRS reduction (p=0.003)
o 8-week study
o (baseline, 6 weeks, final visit)
o 0 SAEs
o 30% Treatment-Emergent AEs (fatigue, dizziness
fatigue)
9. PD-LID Market Opportunity
• Overall Parkinson’s Disease patient population = 1M in US
• Growing 3.5% annually, approximately 60,000 newly diagnosed patients/year
• 2014 → 188,000 patients with LID
o 75% diagnosed Parkinson’s patients are prescribed levodopa
• 10% risk of LID over first 5 years
• 35% risk of LID over 6-9 years
• 90% risk of LID over 10 years and beyond
• Competing drug Gycovri priced at $28,000/year implying $2B+ market opportunity
PD LID → One of largest Orphan Indications
10. Benchmarking Elto Pharma Valuation:
Historic Public Valuations of CNS Companies by Stage of Lead
Current Development Stage
11. Elto Pharma, Inc. Investment Thesis
• Phase 2 small compound program in PD-LID
o Open IND for Phase 2 multiple dose study (IND 124,224, eCTD format)
o Orphan Drug Designation in PD-LID
o Mechanism of action directly relevant to disease state
Distinct from MoA of Gycovri
o $2B+ market opportunity for Eltoprazine in PD alone
o ~$6M to Phase 2b data
• Strong safety profile demonstrated in previous studies in over 680 subjects
• Potential utility in additional large indications
o Agitation in Alzheimer’s disease($3B+ market opportunity)
o ADHD (Adult and Pediatric)
• Demonstrated market/medical/regulatory receptivity to new approaches in this Orphan
indication
o Adamas: GYCOVRI® (amantadine XR)
13. What is ESS and How Is It Made?
13
Skin
Sample
Sent to
cGMP
lab
Epidermal and Dermal Cells
Isolated and Grown
Separately
Cells Seeded
onto Absorbable
Matrix and
Grown in Culture
Full Thickness Skin
grafts are Packaged,
then Couriered to
the Burn Center
14. Severe Burns: Intractable Issues Faced by Patients and Surgeons
14
1st Degree 2nd Degree 3rd-4th Degree
3rd- 4th° burns over ≥ 30% of the Total Body Surface Area (TBSA)are life-threatening
because of high infection rates and length of time to adequate wound closure
• Minimizing time to full wound closure is paramount to limit infection risk
• Minimizing donor skin for grafting is critical to limit surgeries/pain
• Using Patient’s own skin dramatically reduces rejection risk (graft vs. host)
• Grafts that grow with patients are especially critical in pediatric patients to
reduce grueling annual/semi-annual reconstruction surgeries
Epidermis
Dermis
S.C. Fat
15. Patient Presentation and Product Application
15
Boyce et al, “Randomized, Paired-Site Comparison of Autologous Engineered Skin Substitutes and Split-
Thickness Skin Graft for Closure of Extensive, Full-Thickness Burns”, JBRR (2017).
B. Application of ESS
and Autograft
62 days28 days
1-year post- operative evaluation
A. Pre-operative
Wound bed
C. 28 Day Post
Operation
D. 62 Day Post
Operation
16. ESS Provides Massive Improvement vs. Standard of Care
in Pediatric Severs Burns
• 16 subject pediatric clinical trial
- Data published in April 2017 in Journal of Burn Care & Research
• Key Findings:
- ESS reduces mortality (death) by 75% + vs. historical control
- ESS covered 27x greater body surface/harvest vs. standard of care
- ESS yielded pliable, flexible skin that grew as patients matured (less reconstruction)
Figure 4. Plots of ratio of areas of closed wounds to donor
biopsies, percentage mortality, percentage engraftment,
and percentage TBSA at POD 28. A. Ratios of closed-to-
donor areas at POD 28 were 108.8 ± 9.7 for ESSs and 4.0 ±
0.0 for AG. B. Percentages mortality were 6.25% (1/16) for
subjects enrolled and treated under the IDE protocol,
which was significantly lower than 30.3% (305/1008) as
reported in the 2012 National Burn Repository.
Boyce et al, “Randomized, Paired-Site Comparison of Autologous Engineered Skin Substitutes
and Split-Thickness Skin Graft for Closure of Extensive, Full-Thickness Burns”, JBRR (2017).
17. 17
Unconditional Support from
Former Presidents of the American Burn Association
“ESS offers hope to care providers, who
treat severely wounded individuals, that a
reliable skin substitute will be available
for the horrible situation when wound
coverage is not possible. I have long
wanted to see ESS developed so that we
can offer this life-saving technology to our
patients.“
Dr. Nicole Gibran,
Former President, American Burn
Association
“The fact that this product is not on (the)
market is the biggest disappointment of
my career”.
Dr. David H. Ahrenholz
Former President, American Burn
Association
18. ESS: Direct Hospital Costs for 30%+ TBSA 3rd/4th Degree
Pediatric Severe Burns
Standard of Care ESS
Days in ICU (to wound closure) 75-120 35-45
Avg Cost in ICU ($10,000/day) $750,000 - $1,200,000 $350,000 - $450,000
Days in hospital post ICU 90-120 45-75
Avg Cost in Hospital ($3,000/day) $270,000 - $360,000 $135,000 - $165,000
Reconstruction/revision surgeries $100,000 - $10,000,000 $50,000 - $500,000
TOTAL HOSPITAL COSTS $1,120,000 - $11,560,000 $535,000 - $1,115,000
ESTIMATED SAVING/PATIENT $585,000 - $10,410,000
18
ESS Reduces Key Primary Cost Drivers:
o Length of Stay in ICU/Hospital
o Rehabilitation: physical (significantly less with ESS), mental and emotional
o Revision surgeries: mandatory in pediatric patients (significantly less with ESS)
19. Additional Value Proposition:
Rare Pediatric Disease Designations (RPDD)
• RPDD approval gives sponsor a Priority Review Voucher (PRV) that can be used
for another treatment in development
o Vouchers are highly sought, and can be sold to third parties
1. Sarepta Sanofi for $245M , 5/2015
2. United Therapeutics Abbvie for $350M, 8/2015
3. Sarepta Gilead for $125M, 9/2016
• ESS likely qualifies for RPDD in Pediatric Burns & other orphan pediatric diseases
19
20. Cutanogen Corporation: Investment Thesis
• Differentiated autologous skin replacement fulfilling critical unmet need
• Platform technology serving as basis for organ regeneration company
• Phase 3-ready w/Orphan Drug Designation assigned in Severe Burns
• Likely rapid adoption in pediatric severe burns due to:
o Speed to wound closure to < 45 days from 90-180 days:
o Cost savings. $10k- 15k/day, $0.5M –$10M per patient
o Strong, public support from leading KOLs in US
• Non-dilutive funding opportunities
• Proprietary technology with issued patent estate
• Follow-on improvements/indications possible
• Strong KOL support
20 $500+ million initial market opportunity
21. MANF Therapeutics, Inc.
Amarantus
MANF Therapeutics
MANF
(Ophthalmology)
Cutanogen
ESS
(Severe Burns)
Avant Diagnostics
Theralink (Cancer)
MS Precise (Multiple Sclerosis)
LymPro (AD)
OvaDx (Cancer)
Amarantus Diagnostics
merged into
Elto Pharma
Eltoprazine
(Parkinson’s)
= Orphan Drug Designation
22. MANF: Protective/Restorative Across Several Therapeutic Areas
22
MANF
Ophthalmology
DiabetesCardiovascular
Retinitis Pigmentosa
Glaucoma
Retinal Artery Occlusion (RAO)
Neurology
Parkinson’s disease
Stroke
23. Pipeline in a Protein: Anti-Apoptosis Across Indications
• Indications
o Retinitis Pigmentosa, Glaucoma, Retinal Artery Occlusion (rods, cones, retinal ganglion cells)
o Parkinson’s (neuronal protection)
o Diabetes (protection of pancreatic beta cells)
o Myocardial infarction (protection against ischemic damage)
o Hearing loss (preservation of hair cells)
o Wolfram’s (blindness, neurological, hearing loss and diabetes aspects)
• Potential paradigm shift in cell protection and restoration
o Collaborations w/ Buck Institute, Wash U and UMass
o 75+ peer-reviewed publications (Science , Nature Medicine, etc.)
o 20+ issued patents, 20+ pending patent applications
o Composition of Matter issued covering Protein, Gene and cell therapy
o Method of Use in Neurology, Ophthalmology, Endocrinology, Otology, Immunology
23
24. Retinitis Pigmentosa is Lead Indication
• 100,000 patients/yr in USA
- MANF initially targeting 50,000 sub-population
• Genetic disease of the retina
- Orphan indication
- No treatment currently approved
• Progressive vision loss
- Rod photoreceptors followed by cone degeneration
- Night vision loss followed by loss of peripheral vision
• Mutations in the rhodopsin gene
- Mutated rhodopsins misfold and aggregate
24
Figure from Palczewski et al., 2000
25. MANF Protects Retinal Function / Retina in rd10/rd10 Rodent Model
• Abstract published at ARVO 2015
- Bascom Palmor Institute University of
Miami (Prof. Rong Wen)
• Single ivt admin of MANF (2 ug) on Day 18
• Effect on scotopic ERG b wave amplitude on Day 28
25
MANF protects inner retinal function in rd10/rd10 model
**
26. Treatment groups (mean±SEM)
MANF Protects Vision Function in
Glaucoma / RAO Optic Nerve Ischemia Rodent Model
• Occlusion / reperfusion model
- Retinal artery occlusion – orphan indication
- Glaucoma
• Single intravitreal
- MANF administration immediately after occlusion / reperfusion
• Electroretinography, b-wave amplitude on Day 7
26
1. Functional protective effect against retinal ischemia
2. Dose-effect relationship mirrors effects in Parkinson’s disease model
3. Most effective dose has a safety margin compared to the ocular tolerance study dose
4. MANF effect similar to Alphagan despite completely different MOA
26AMBS sponsored data. CRO: Iris Pharma. * P<0.05, 1-way ANOVA, Dunn’s post test against PBS control
27. MANF : Clinical Development Strategy
• Local Delivery of Recombinant Protein Initial Development Strategy at AMBS
o Potential for systemic administration upon safety study confirmation
o Potential for Gene Therapy
o Potential for Cell Therapy
• Ophthalmology→ Initial Lead indications
o Retinitis Pigmentosa (Orphan Drug Designation)
o Retinal Arterial Occlusion (Orphan Drug Designation)
o Wolfram’s syndrome
o IND submission targeted for 2019
• Additional indications with animal proof of concept:
o Parkinson’s
o Diabetes
o Myocardial Infarction
27
Lindholm and Saarma, DevNeurobiol (2010)
28. AMBS Trading Snapshot
2
8
Highlights
• Trading Symbol: AMBS
• All-time high PPS: $30/share
• All-time high market cap: $160M
• Market Cap: $2 Million (as of 11/28/2017)
• Closing Stock Price: $0.02 per share (as of 11/28/2017)
• Shares Outstanding: ~120 Million Shares (as of 11/28/2017)
• Convertible Securities: $22M (as of 11/28/2017)
o $21M out of $22M halted all conversions until 1/10/18
o $1M 1st lien Sr. Debt able to trade out of position
o If AMBS raises $1.5M by 1/10/18 conversions halted until 10/10/18
o $21M exchanged at discount into non-convertible securities
o If AMBS uplists to national exchange by 7/10/18 conversions halted until
2/10/19 (severe leakout for 9 months quarterly fixed price conversion)
29. AMBS Investment Highlights
• Holding company structure designed to capture subsidiary value
• Elto Pharma: Eltoprazine is a Phase 2b clinical asset for PD-LID
o Launched Phase 2b study in PD LID in June 2015
o Orphan designation obtained
o Opportunities to expand into Adult ADHD, Alzheimer’s Aggression
• Cutanogen Corporation: ESS is a Phase 3 clinical asset for pediatric severe burns
o Orphan designation obtained
o Intent to request Rare Pediatric Disease Designation (RPDD) to be eligible for Priority Review Voucher
(PRV)
• MANF Therapeutics: MANF is a paradigm-shifting preclinical asset
o Orphan Drug Designation in Retinitis Pigmentosa and Retinal Artery Occlusion
o Multiple indications currently advancing towards first-in-human studies
29
30. Contact Information
30
Gerald E. Commissiong
President & CEO
Amarantus Bioscience Holdings, Inc.
953 Indiana St.
San Francisco, CA 94107
website: http://www.amarantus.com
email: gerald.commissiong@amarantus.com
Phone: 650-862-5391