Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
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.
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 the primary endpoint for its phase 2 clinical trial and the Company is now enrolling in a global phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary discovery technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody (mAb) approach is a proven mechanism of action and has shown preliminary trend toward efficacy as an adjunctive 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. The company also has an on-going phase 2 clinical trial for the treatment of Cystic Fibrosis patients, 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 a self-administered broadly neutralizing mAb 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.
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®.
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
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.
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.
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
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.
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 the primary endpoint for its phase 2 clinical trial and the Company is now enrolling in a global phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary discovery technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody (mAb) approach is a proven mechanism of action and has shown preliminary trend toward efficacy as an adjunctive 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. The company also has an on-going phase 2 clinical trial for the treatment of Cystic Fibrosis patients, 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 a self-administered broadly neutralizing mAb 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.
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®.
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
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.
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.
Genetic Technologies is an Australian company focused on developing and commercializing genetic risk assessment tests. The presentation provides an overview of the company's business, including its portfolio of current and upcoming genetic tests, markets and channels to market, and capabilities. Key points include:
- Genetic Technologies aims to offer the most comprehensive suite of genetic risk assessment tests on the market, covering up to 70% of disease risks.
- The company is prioritizing market entry strategies in key regions like Australia, the US, and Asia.
- Tests are marketed through consumer-initiated and medical business-to-business channels.
- An innovative pipeline of new tests for diseases like cancer, heart disease, and diabetes is being
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.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology.
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.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
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.
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.
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 the primary endpoint for its phase 2 clinical trial and the Company is now enrolling in a global phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary discovery technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody (mAb) approach is a proven mechanism of action and has shown preliminary trend toward efficacy as an adjunctive 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. The company also has an on-going phase 2 clinical trial for the treatment of Cystic Fibrosis patients, 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 a self-administered broadly neutralizing mAb 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.
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®.
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.
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.
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.
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.
Liquid biopsy from a simple blood test enabling personalised cancer care | Sh...ANGLE plc
Liquid biopsy from a simple blood test is enabling personalised cancer care. The Parsortix system from ANGLE can harvest cancer cells from blood (liquid biopsy) in a non-invasive and repeatable way. This provides a new approach to obtaining cancer cells for analysis compared to traditional tumour biopsies. Key opinion leaders have evaluated the Parsortix system and found that it captures all types of cancer cells with high purity in an easy to use process, making it well suited for clinical applications in personalised cancer care.
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.
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.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
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.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Genetic Technologies is an Australian company focused on developing and commercializing genetic risk assessment tests. The presentation provides an overview of the company's business, including its portfolio of current and upcoming genetic tests, markets and channels to market, and capabilities. Key points include:
- Genetic Technologies aims to offer the most comprehensive suite of genetic risk assessment tests on the market, covering up to 70% of disease risks.
- The company is prioritizing market entry strategies in key regions like Australia, the US, and Asia.
- Tests are marketed through consumer-initiated and medical business-to-business channels.
- An innovative pipeline of new tests for diseases like cancer, heart disease, and diabetes is being
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.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology.
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.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
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.
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.
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 the primary endpoint for its phase 2 clinical trial and the Company is now enrolling in a global phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary discovery technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody (mAb) approach is a proven mechanism of action and has shown preliminary trend toward efficacy as an adjunctive 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. The company also has an on-going phase 2 clinical trial for the treatment of Cystic Fibrosis patients, 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 a self-administered broadly neutralizing mAb 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.
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®.
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.
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.
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.
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.
Liquid biopsy from a simple blood test enabling personalised cancer care | Sh...ANGLE plc
Liquid biopsy from a simple blood test is enabling personalised cancer care. The Parsortix system from ANGLE can harvest cancer cells from blood (liquid biopsy) in a non-invasive and repeatable way. This provides a new approach to obtaining cancer cells for analysis compared to traditional tumour biopsies. Key opinion leaders have evaluated the Parsortix system and found that it captures all types of cancer cells with high purity in an easy to use process, making it well suited for clinical applications in personalised cancer care.
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.
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.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
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.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Sutro Biopharma is conducting a Phase 1 clinical trial of STRO-002, an antibody-drug conjugate (ADC) targeting folate receptor alpha (FolRα), in patients with advanced platinum-resistant or refractory epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. Interim data from the trial will be presented at the AACR virtual conference on April 27th. STRO-002 was designed using Sutro's proprietary protein engineering platform, XpressCF, to have improved stability and a widened therapeutic index compared to other FolRα-targeting ADCs. Preclinical studies demonstrated STRO-002's enhanced potency and specificity versus benchmarks. The trial will evaluate
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
Exact Sciences Corp. announced that the company continued its strong performance during the third quarter ended Sept. 30, 2015, completing 34,000 Cologuard tests, an increase of 60 percent from the second quarter, which resulted in $12.6 million in revenues. The cumulative number of ordering physicians grew to 21,000 during the quarter, an increase of 42 percent.
Soligenix is a late-stage biopharmaceutical company specializing in developing and commercializing products to treat rare diseases with unmet medical needs. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™, a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and is now negotiating a confirmatory Phase 3 pivotal study design with the US Food & Drug Administration, while also evaluating/pursuing potential HyBryte™ marketing approval ex-U.S. with the successfully completed Phase 3 study.
Aridis Pharmaceuticals is advancing multiple clinical stage monoclonal antibodies (mAbs) targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients.
The document provides an overview of Exact Sciences and its colorectal cancer screening test Cologuard. It discusses Cologuard's performance in clinical trials, cost-effectiveness, growing adoption rates, and commercial strategy to increase screening rates in the US. Exact Sciences expects over 240,000 Cologuard tests to be completed in 2016, up from 104,000 in 2015, and revenue is forecasted to be between $90-100 million.
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.
This corporate presentation discusses Cologuard, a non-invasive stool DNA screening test for colorectal cancer. It summarizes Cologuard's strong clinical trial results and growing adoption by physicians and patients. Projections show Cologuard's potential to detect thousands of cancers in 2016 and its multi-billion dollar market opportunity in the large colorectal cancer screening market in the United States.
Dupilumab is an investigational monoclonal antibody that targets IL-4 and IL-13, key drivers of the type 2 inflammatory response in atopic dermatitis (AD). Two phase 3 clinical trials, SOLO 1 and SOLO 2, evaluated the efficacy and safety of dupilumab in adults with moderate-to-severe AD. The results from these trials showed that dupilumab monotherapy significantly improved measures of disease severity such as EASI, IGA, and pruritus scores compared to placebo. Treatment with dupilumab also led to rapid and significant improvements in skin clearance and quality of life measures. The safety profile observed was generally consistent with the mechanism of action and the patient population.
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services for cancer evaluation. IDXG operates two CLIA-certified labs and has four proprietary molecular diagnostic tests for pancreatic cysts and thyroid nodules that assess cancer risk. The tests have high margins and barriers to entry due to reimbursement and complexity. Recent accomplishments include raising funds, improving financials, expanding insurance coverage and launching international distribution. The molecular diagnostic market is large and growing due to advantages over drug development. IDXG's tests establish new standards in cancer risk assessment for pancreatic cysts and thyroid nodules compared to current guidelines.
Exact Sciences chairman and CEO Kevin Conroy delivered the company's presentation at the 2015 Baird 2015 Healthcare Conference in New York at 9:40 a.m. ET on Wednesday, Sept. 9.
An archive of the webcast is available here: http://wsw.com/webcast/baird43/register.aspx?conf=baird43&page=exas&url=http://wsw.com/webcast/baird43/exas/index.aspx
Ron Najafi, Chairman and CEO of NovaBay Pharmaceuticals, provided an update to shareholders at their annual meeting. NovaBay is developing new anti-infective products to address the growing crisis of antibiotic resistance. Their lead product candidates include auriclosene, which has shown effectiveness against bacteria, viruses, and fungi in clinical trials for conditions like conjunctivitis and impetigo, without inducing resistance. NovaBay also markets NeutroPhase, a pure hypochlorous acid solution for wound care. They anticipate results from multiple global phase 2 clinical trials in 2013 and have established partnerships to commercialize their products in key markets.
Ctxr presentation mid-size_02.22.2019_spring.finalScott Martin
This 3-page corporate presentation by Citius Pharmaceuticals provides an overview of their investment opportunity and pipeline. Their lead product Mino-Lok is in Phase 3 trials for treating central line-associated bloodstream infections (CLABSI) and has the potential to salvage infected central venous catheters rather than requiring removal. They have a Phase 2 product for hemorrhoids and a pre-clinical product for preventing breast implant infections. The presentation highlights the large market opportunities and management team's experience advancing 505(b)(2) products.
- Sanofi's CEO Olivier Brandicourt presented at a healthcare conference on September 14, 2018.
- He discussed Sanofi's continued progress on its strategic transformation including acquiring new assets, driving simplification through restructuring, reshaping its portfolio, and executing new product launches.
- Brandicourt highlighted several potentially significant drug approvals and trial results for new drugs and indications expected over the next 12 months that could further advance Sanofi's growth.
- He concluded that while Sanofi saw impacts from recent drug losses of exclusivity in the first half of 2018, performance was otherwise in line with expectations and several factors position Sanofi for a new growth phase in the second half of
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.
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Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...The Lifesciences Magazine
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Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
Presently, generalist IT manpower does most of the work in the healthcare industry in India. Academic Health Informatics education is not readily available at school & health university level or IT education institutions in India.
We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
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Cancer treatment has advanced significantly over the years, offering patients various options tailored to their specific type of cancer and stage of disease. Understanding the different types of cancer treatments can help patients make informed decisions about their care. In this ppt, we have listed most common forms of cancer treatment available today.
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Dr. Sherman Lai, MD — Guelph's Dedicated Medical ProfessionalSherman Lai Guelph
Guelph native Dr. Sherman Lai, MD, is a committed medical practitioner renowned for his thorough medical knowledge and caring patient care. Dr. Lai guarantees that every patient receives the best possible medical care and assistance that is customized to meet their specific needs. She has years of experience and is dedicated to providing individualized health solutions.
Bashundhara Toiletries Logo Guideline 2024khabri85
It outlines the basic identity elements such as symbol, logotype, colors, and typefaces. It provides examples of applying the identity to materials like letterhead, business cards, reports, folders, and websites.
2. 2
Forward Looking Statement
These forward-looking statements relate to future events or future financial performance of the
Company. All such forward-looking statements involve risks and uncertainties and are not guaranties
of future performance. An investment in the securities of Aridis is speculative in nature, involves a
high degree of risk, and should not be made by an investor who cannot bear the economic risk of its
investment for an indefinite period of time and who cannot afford the loss of its entire investment.
These include many important factors that affect our ability to achieve our stated objectives including,
but not limited to:
* The timing of regulatory submissions;
* Our ability to obtain and maintain regulatory approval of our existing product candidates and any
other product candidates we may develop, and the labeling under any approval we may obtain;
* Approvals for clinical trials may be delayed or withheld by regulatory agencies;
* Pre-clinical and clinical studies will not be successful or confirm earlier results or meet expecta-
tions or meet regulatory requirements or meet performance thresholds for commercial success;
* The timing and costs of clinical trials, the timing and costs of other expenses;
* Our ability to obtain funding from third parties;
* Management and employee operations and execution risks;
* Loss of key personnel;
* Competition;
* Market acceptance of products;
* Intellectual property risks;
* Assumptions regarding the size of the available market, benefits of our products, product pricing,
timing of product launches;
* The uncertainty of future financial results;
* Risks associated with this offering;
* Our ability to attract collaborators and partners;
* Our reliance on third party organizations.
We operate in a very competitive and rapidly changing environment. New risks emerge from time to
time. It is not possible for our management to predict all risks, nor can we assess the impact of all
factors on our business or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking statements we may make. In
light of these risks, uncertainties and assumptions, the forward-looking events and circumstances
discussed in this presentation may not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking statements.
Except as required by law, neither we nor any other person assumes responsibility for the accuracy
and completeness of the forward-looking statements. We undertake no obligation to update publicly
any forward-looking statements for any reason after the date of this presentation to conform these
statements to actual results or to changes in our expectations.
We have filed a registration statement (including a prospectus) with the Securities and Exchange
Commission ("SEC") for the offering to which this communication relates. Before you invest, you
should read the prospectus in the registration statement and other documents we have filed with the
SEC for more complete information about us and this offering. You may get these documents for free
by visiting EDGAR on the SEC web site at http://www.sec.gov. Alternatively, we, any underwriter, or
any dealer participating in the offering will arrange to send you the prospectus if you request it from
Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY
10022; email: prospectus@cantor.com. This presentation shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.
3. 3
Targets IND
Pre-Clinical
Products Phase 2
Phase 1 Phase 3
Gram (+) Bacteria
S. aureus a-toxin
Pneumonia & Blood Stream Infections
HAP/VAP
Cystic Fibrosis
COVID-19
Gram (-) Bacteria
P. aeruginosa LPS O11
Gram (-) & (+)
Iron Acquisition Systems
COVID-19
AR-301 mAb
(Salvecin)
AR-101 mAb
(Aerumab)
AR-501
(Panaecin)
AR-711 mAb
Bacteremia
A. baumannii
AR-401 mAb
Product Pipeline
Next
Milestone
Interim Futility
data 1H2021
Phase 2/3
tbd
Phase 2a data
2H2021
Ph1/2
1H2021
IND
4Q2021
Gram (-) Bacteria
RBD mAb
4. 4
Multi-drug-resistance
Pseudomonas Aeruginosa
including methicillin
https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf
Patient population: Patients in healthcare settings
frequently get severe or potentially
life-threatening infections
Severe infections/yr: 80,461
Methicillin resistant: 42 - 55%
Deaths per year
aminoglycosides, quinolones
Patient population: Patients in hospitals, on ventilators,
indwelling devices, and patients with
wounds from surgery
: 51,000
Multidrug resistant: 13%
: 440
6,700
multidrug resistance
pseudomonas
infections
pseudomonas
infections per year
deaths
440 51,000
Methicilin-resistance
Staphylococcus Aureus (MRSA)
80,461
severe MRSA infections per year deaths
11,285
Key Bacterial Targets: S. aureus and P. aeruginosa
5. 5
Kyaw MH et al., 2015 BMC Health Serv Res. 15:241
Restrepo (2010) ICHE 31:509-515
Hospital Days
7.2
60 days
40 days
20 days
$220,000
$110,000
Control Staph Pseudomonas Control Staph Pseudomonas
37.9
55.4
$33,851
$146,978
$213,104
In-Patient Costs
ICU stay
All Cause
Mortality
1.1 day 6.9 days 14.8 days
3% 16% 20%
1.1 day 6.9 days 14.8 days
3% 16% 20%
~252,000 ICU patients
US claims database (2018)
n=201 n=394
Healthcare Burden of S. aureus and P. aeruginosa
Hospital 44.4%
%
0
.
1
2
y
c
a
m
r
a
h
P
%
3
.
6
1
y
r
o
t
a
r
o
b
a
L
Respiratory Treatment (Mech. ventilation) 9.3%
Radiology (+CT Scans) 3.3%
%
9
.
1
y
g
o
l
o
i
d
r
a
C
Operating Room 1.4%
Diagnostics (Blood ECG) 1.9%
Pulmonary Diagnostic 0.4%
%
3
.
0
c
i
d
a
e
p
o
h
t
r
O
Survey of 30 cases (median)
6. 6
Normal Alveolus
PMN
Macrophages
α-toxins
α-toxins
Staphylococcus aureus
Staphylococcus aureus
Targets S. aureus α-Toxin
Necrosis
Alveolar
air space
Type 1 cells
Interstitium
Anti-toxin monoclonal
antibody approach is a
proven MOA, e.g.
Anthrax mAb Raxibacumab (GSK-EBSI)
S. Aureus mAb MEDI4893 (AZN)
Intact
Immune Cell
Gram (+) bacteria: S. aureus
mAb
α-toxins attacking
immune cell
Red blood cells
Neutrophils
Macrophages, Monocytes
Toxins 2013, 5(6), 1140-1166
T-cells
Pneumoncytes
Endothelial cells
AR-301 Mechanism of Action:
Host cells killed by α-toxins
Commercialized
Under development
7. 7
100
100
9
8
7
6
5
90
80
80
70
60
60
50
40
40
30
20 20
10
5.00
IgG1A
control
IgG1
alone
alone
50 mg/kg
3 mg/kg
3 mg/kg
control IgG1
AR-301
AR-301
Saline
Vanco
50 mg/kg
Vanco
AR-301
AR-301
Bacteria
count
in
lung
(x
10
6
)
Mortality
(%)
0.50
0.25
0.20
0.10
0.05
0.025
0 0
100
80
60
40
50
hours hours
100
20
Survival
(%)
0
0
+
(Mouse model of S. aureus pneumonia)
In-vitro Animal Model
Protection against
killing of host cells
AR-301 (µg/ml)
p = 0.01
AR-301 mAb Pre-Clinical Potency Data
8. 8
Antibiotics-alone Adjunct therapy
Standard
of Care
Standard
of Care
AR-301
Superiority Trial Design
VS.
With positive data, provides for value-based premium reimbursement
Therapeutic Treatment in Acute Pneumonia Setting
9. 9
Randomized, double-blind, placebo-controlled, single ascending dose of AR-301
31 sites across EU and U.S.
SOC [antibiotics alone] + Placebo n=16
SOC + AR-301 (1 mg/kg ) n= 6
SOC + AR-301 (3 mg/kg) n= 8
SOC + AR-301 (10 mg/kg) n=10
SOC + AR-301 (20 mg/kg) n= 8
48 patients with HAP or VAP caused by S. aureus
Safety and pharmacokinetics
Data trend in favor of adjunctive treatment benefit
Time to removal of ventilator (VAP patients)
Microbiological cure
Shorter time to eradication
Days in ICU
Design
Patient Selection
Groups
Primary Endpoint
Secondary Endpoint Hospitalization days
All-cause mortality
Clinical cure rate
AR-301 Phase 2: Trial Recently Completed
10. 10
Antibiotic
Half Life
20 mg/kg
(hours) Time since start of infusion
50% (half-life mark)
Mean
Plasma
Concentration
24 48 72 96 120 144 168
0
ug/mL
200
ug/mL
400
ug/mL
600
ug/mL
Adjunctive AR-301 treated groups were well
antibiotics alone (placebo) group (n=48).
Few adverse events (AEs) deemed related to
AR-301 (2.8%).
No serious adverse events (SAEs) related to
AR-301.
Deaths were deemed unrelated to AR-301
treatment (n=6).
(plasma half-life of 23-31 days)
AR-301
AR-301: Favorable Phase 2 Safety & PK Data
11. 11
Ventilation
days
(Mean)
Placebo + SOC 1 3 10 20
5
5 4
AR-301 (mg/kg) + SOC
Number of
patients
days
days
days
days
days
7 4
23.4
7.2
4.8
17
10
Treatment effect on mechanical ventilation days
Phase 2a: AR-301 Data
Source: AR-301 Phase 2a, 2017
Trend toward significantly lower
ventilation days in all AR-301 treated
patients.
Ventilation days in microbiologically confirmed
intent-to-treat population (VAP patients) are
shown.
p < 0.01 for placebo vs. AR-301 (pooled) based
on post-hoc analysis of VAP patients.
Significant Reduction in Ventilation Days with Adjunctive AR-301 Treatment
Time on Mechanical Ventilation
12. 12
Probability
of
Receiving
Mechanical
Ventilation
Days on Mechanical Ventilators
+AR-301 Pooled (n=20)
Antibiotics alone (n=5)
5 10 15 20 25
100%
80%
60%
40% 40%
50%
improvement
20%
Probability
of
Receiving
Mechanical
Ventilation
0
Francois, B. et al. 2018 Intensive Care Medicine.
Aggregated AR-301 treated VAP groups
exhibited lower probability of requiring
mechanical ventilation vs. placebo.
Phase 2
13. 13
1-to-1 randomized,
double-blind,
placebo-controlled, single
dose IV infusion
Enrolling 240 patients with
VAP caused by S. aureus
across 125 sites in 20
countries (U.S., EU, Asia)
Evaluating the potential of
adjunctive AR-301 (20 mg/kg)
to SOC antibiotics vs.
antibiotics alone
Primary endpoint of clinical
cure rate at day 21
Interim futility analysis of 120 patients
readout in 2H2021
Test of
Clinical
Cure
Randomize
& Treat
infusion
AR-301 at 20 mg/kg
IV infusion
n = 120
Day 21
n = 120
Broad
spectrum
antibiotics
Broad
spectrum
antibiotics
(ClinicalTrials.gov ID NCT03027609)
AR-301 Phase 3: Trial Design
in 1H2021 and final data
14. 14
Powering Calculation and Assumptions
n = 240 enrollment target
over-powered to achieve
superior clinical cure rate
p<0.05
** Rationale for 20% absolute
clinical cure rate improvement setting
Considered clinically meaningful to physicians
Ph2a data showed trend toward improvements in
shorter ventilation time & microbiological eradication
(i.e. 2 of the 3 components of the primary endpoint)
AR-301 Phase 3 Study
Study
Power
80%
90%
75%
75%
95%
95%
20%
20%
n = 55
n = 69
n = 110
n = 138
Control
(SOC)*
AR-301
+ SOC
Absolute
**
Evaluable
per group
Total
Enrolled
Primary Endpoint: Clinical Cure Rate
15. 15
Sources
Potential S. aureus HAP/VAP Patients by Market
395,000 Patients in the US, Japan, EU
Gram (+) Staphylococcus aureus-Induced HAP/VAP
Lifecycle opportunities include surgical site, skin/skin structure, UTI, and BSI infections due to S. aureus
Estimated $6 billion annual healthcare cost burden attributable to
S. aureus nosocomial pneumonia
Breakdown
of Strains 48%
52%
1 DR/Decision Resources, LLC. 2016;
2 Chastre J, and Fagon J-Y, Ventilator-associated pneumonia, State
of the Art, Am J Respir Critical Care Med, 2002 (165): 867-903.
3 Warren DK, Outcome and Attributable Cost of VAP among ICU
patients in a suburban medical center,
Critical Care Med 2003;31(5):1312-7.
MRSA
MSSA
90,000
251,600
U.S.A.
Japan
53,700
Europe
$6 Billion Market for (AR-301): VAP, HAP
16. 16
SOC antibiotics in HAP/VAP:
Avycaz / ceftazidime/avibactam (AstraZeneca): $13,764 (14 days course)
Vibativ/ Telavancin (Astellas): $8,841 (21 days course)
Pneumonia caused by MRSA
$1,000
AR-301 Product Contribution
Key Assumptions
First-line adjunctive treatment
MRSA only HAP / VAP / HCAP
60% marketshare
US / EU / Japan
$10,500 per course
$Million
(Net
of
Expenses)
$800
$600
$400
$200
$00
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034
1st Phase 3 2nd Phase 3 BLA & Launch
17. 17
AR-301
Pre-Emptive Treatment In S. Aureus Colonized Patients Also Show Evidence
of Clinical Benefits
At-risk (non-infected)
Asymptomatic
Lung colonized, High risk
Asymptomatic
Decreased risk of VAP 32%
Decreased risk of VAP 47% (<65 yrs old)
Full-on lung infection
Ventilator-assoc. pneumonia
Prophylactic
AstraZeneca’s
Suvratoxumab
Pre-emptive
Phase 2 Results (n=196)*:
[data 1Q2021]
Phase 3 (n = 240)
Treatment for Acute
AR-301 Data: Proxy Data from AZN’s Suvratoxumab
18. 18
AR-501: Novel Inhaled Non-Antibiotic
Mechanism of Action
Small Molecule Anti-infective
Iron (Fe) is necessary for bacterial metabolic
functions. AR-501 (gallium, Ga) replaces Fe
AR-501 impairs mulitple bacterial functions
Standard antibiotics inhibit single targets
Ga
Gallium
19. 19
PARI eFlow
nebulizer
AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients
Phase 1 Healthy Volunteers
(1H-2019) Single Ascending Dose
6 mg
18 patients 6 patients
20 mg
AR-501
Done
AR-501
Placebo
18 patients 6 patients
Placebo
40 mg
6 mg 20 mg 40 mg
(1H-2020) Multiple Ascending Doses
t = 0, 1, 2, 3, 4 weeks
Done AR-501
30 patients 15 patients
Placebo
6 mg 20 mg 40 mg
(2H-2021) Multiple Ascending Doses
t = 0, 1, 2 weeks
Phase 2 Cystic Fibrosis Patients
Primary Endpoint:
Safety and PK
Secondary Endpoints:
Lung function of CF patients
(changes in FEV1)
Sputum bacteriology
Data Readout:
Phase 2a CF subjects in 2H2021
CF Foundation Funded
Ph1 study results: AR-501 was well tolerated
20. 20
Sputum
concentration
mg/mL
300
IV
Inhaled
(est.)
2
Gallium
Gallium
Placebo
Placebo
1
10%
8%
6%
4%
2%
0%
-2%
-4%
-6%
6 14 28 56
60 60 58 60 59
59 57 57 56 56
Day Days Days Days Days
Patients Patients Patients Patients Patients
Mean
Relative
Change
from
Baseline
FEV
(L)
Intent to Treat Population CF Patients
Inhaled
Delivery
A single IV dose of gallium resulted in statistical
significant improvement in lung infection
Data from University of Washington: Goss, C. et al. 2018
N. Am. Cystic Fibrosis Conference Abstract #307 (*estimate based on animal PK data)
Phase 2 Outcome
of IV Gallium
Provides
Strong Rationale
for Inhaled
Delivery
21. 21
3
0
Months
6 9 12 15 18 21 24 27
TRADITIONAL: Discovery, Development, and Manufacturing
APEX TM
Discovery, Development, and Manuf. 12-15 months time saving
Convalescent
COVID-19 patient
B-cell
Selected
Cloned CDRs
or H&L of IgG’s
APEX TM
Nanoarrays
B-cell
repertoire screening
B.R.E.A.T.H. TM
CHO cell line
CRISPR
Guided Integration
GMP
Manufacturing
/PEX mAb Discovery and
Production Platform Technology
22. 22
AR-711: Inhaled COVID-19 mAb Program
Highly potent SARS-CoV-2 fully human mAb from convalescent COVID-19 patients
- Proprietary stable inhaled formulation designed for direct lung delivery
-Therapeutically eradicated SARS-CoV-2 at ultra low dose (~0.05 mg/kg) in
animal challenge model
- Up to year-long protection (engineered for plasma half-life extension)
- Engineered removal of antibody disease enhancement (ADE) risk
Target Populations
- Designed to lower the barrier to COVID-19 treatment in outpatients
-Treatment mild to moderate COVID-19 non-hospitalized patients
- Prophylaxis [elderly, high risk frontline workers, etc]
https://www.biorxiv.org/content/10.1101/2020.10.14.339150v1.
24. 24
Vu Truong
CEO, Director
(Formerly Medimmune, Aviron)
Michael Nazak
Chief Financial Officer
(Formerly Coherus, intekrin)
Steve Chamow
VP, Development
(Formerly Genentech, Abgenix)
Hasan Jafri
Chief Medical Officer
(Formerly AstraZeneca/Medimmune)
Elizabeth Leininger
VP, Regulatory
(Formerly FDA, Novartis)
Mitch Rosner
VP, Quality
(Formerly Synthetic Gen., IDEC)
Lynne Deans
VP, Clinical Operations
(Formerly Roche, Dermira)
Senior Management
25. 25
Eric Patzer, Ph.D.
Director, Chairman
(Co-Founder, Aridis)
Robert Ruffolo, Ph.D., D.Sc.
Director
(Former President Wyeth/Pfizer)
Craig Gibbs, Ph.D., M.B.A.
Director
(Commercial Gilead; Genentech)
John Hamilton, M.B.A.
Director
(CFO, Depomed; BioMarin)
Susan Windham-Bannister, Ph.D.
Director
(Assoc. Women in STEM, Mass. Life Sci. Ctr)
Vu Truong, Ph.D.
Director
(CEO, Aridis)
Board of Directors