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 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.
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.
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.
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.
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.
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
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
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
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.
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.
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.
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.
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.
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
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
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
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.
1) Imugene is developing B-cell peptide cancer immunotherapy vaccines targeting the HER-2 receptor, which is the target of Roche's $6.4 billion breast cancer drug Herceptin.
2) Imugene has completed a Phase 1 clinical trial of its lead HER-Vaxx vaccine in HER-2 positive breast cancer patients, and plans to begin a Phase 1b/2 gastric cancer trial in early 2016.
3) HER-Vaxx induces polyclonal antibody responses against HER-2, unlike monoclonal antibodies, and has the potential to provide long-lasting immunity through immune memory activation.
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.
This document is an investor presentation by PharmAust Limited that includes several disclaimers. It states that the presentation does not contain all information required by investors and should not be considered financial, tax, or legal advice. It also disclaims any representations or warranties regarding the accuracy of the information provided. The presentation is provided for investors to conduct their own independent research on the company. It also cautions that forward-looking statements in the presentation are based on assumptions that may not be realized.
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.
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.
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®.
Therapix Biosciences is a clinical-stage pharmaceutical company focusing on proprietary synthetic cannabinoid technologies developed in Israel, including novel sublingual and nasal formulations of FDA-approved synthetic THC (dronabinol) to treat conditions like Tourette Syndrome and mild cognitive impairment. The company is repurposing dronabinol for new indications by exploring combination therapies based on the "entourage effect" as well as an "ultra-low dose THC" approach for cognitive deterioration and pre-Alzheimer's disease.
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.
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.
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.
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.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
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.
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
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.
Tiziana Life Sciences (NASDAQ: TLSA) Investor Presentation - July 20th 2020RedChip Companies, Inc.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
This document summarizes clinical trial results for a medical device called dermaPACE that uses shockwave technology to treat diabetic foot ulcers. Some key points:
- A supplemental clinical trial of dermaPACE enrolled 130 patients and showed a complete wound closure rate of 22.7% for those treated with dermaPACE versus 18.3% for controls at 12 weeks.
- When combining results from the original and supplemental trials (total 336 patients), treatment with dermaPACE resulted in a statistically significant higher complete wound closure rate of 37.8% versus 26.2% for controls at 24 weeks.
- Subgroup analyses found higher wound closure rates with dermaPACE treatment for those
This document contains forward-looking statements about Interpace Diagnostics' future performance. It discusses the risks, uncertainties, and assumptions involved in forward-looking statements. It also notes that Interpace has filed documents with the SEC regarding its offering that should be reviewed before investing. The document is as of June 5, 2017 unless otherwise noted.
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.
- Bitcoin Shop is one of the first publicly traded companies focused on the virtual currency ecosystem. It operates an ecommerce platform that accepts bitcoin and other cryptocurrencies as payment.
- The company is developing its BTCS 2.0 platform to expand its product offerings and vendor base. It aims to build a virtual currency ecosystem through ecommerce.
- Bitcoin Shop has a experienced management team with expertise in capital markets, technology, and the virtual currency industry. It plans to grow its customer base and monetize through additional service offerings.
This document discusses Genius Brands International and its business model of providing children's entertainment content across multiple platforms. It notes that animated content has enduring appeal across generations and borders. It highlights Genius Brands' existing properties like Baby Genius which have had success on television and other platforms. The document outlines Genius Brands' plans to expand these properties to new distribution channels internationally and through new merchandise programs. It also presents several new animated series concepts in development. Biographies of the Chairman and CEO Andy Heyward and another executive emphasize their experience in children's entertainment.
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.
1) Imugene is developing B-cell peptide cancer immunotherapy vaccines targeting the HER-2 receptor, which is the target of Roche's $6.4 billion breast cancer drug Herceptin.
2) Imugene has completed a Phase 1 clinical trial of its lead HER-Vaxx vaccine in HER-2 positive breast cancer patients, and plans to begin a Phase 1b/2 gastric cancer trial in early 2016.
3) HER-Vaxx induces polyclonal antibody responses against HER-2, unlike monoclonal antibodies, and has the potential to provide long-lasting immunity through immune memory activation.
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.
This document is an investor presentation by PharmAust Limited that includes several disclaimers. It states that the presentation does not contain all information required by investors and should not be considered financial, tax, or legal advice. It also disclaims any representations or warranties regarding the accuracy of the information provided. The presentation is provided for investors to conduct their own independent research on the company. It also cautions that forward-looking statements in the presentation are based on assumptions that may not be realized.
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.
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.
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®.
Therapix Biosciences is a clinical-stage pharmaceutical company focusing on proprietary synthetic cannabinoid technologies developed in Israel, including novel sublingual and nasal formulations of FDA-approved synthetic THC (dronabinol) to treat conditions like Tourette Syndrome and mild cognitive impairment. The company is repurposing dronabinol for new indications by exploring combination therapies based on the "entourage effect" as well as an "ultra-low dose THC" approach for cognitive deterioration and pre-Alzheimer's disease.
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.
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.
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.
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.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
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.
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
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.
Tiziana Life Sciences (NASDAQ: TLSA) Investor Presentation - July 20th 2020RedChip Companies, Inc.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
This document summarizes clinical trial results for a medical device called dermaPACE that uses shockwave technology to treat diabetic foot ulcers. Some key points:
- A supplemental clinical trial of dermaPACE enrolled 130 patients and showed a complete wound closure rate of 22.7% for those treated with dermaPACE versus 18.3% for controls at 12 weeks.
- When combining results from the original and supplemental trials (total 336 patients), treatment with dermaPACE resulted in a statistically significant higher complete wound closure rate of 37.8% versus 26.2% for controls at 24 weeks.
- Subgroup analyses found higher wound closure rates with dermaPACE treatment for those
This document contains forward-looking statements about Interpace Diagnostics' future performance. It discusses the risks, uncertainties, and assumptions involved in forward-looking statements. It also notes that Interpace has filed documents with the SEC regarding its offering that should be reviewed before investing. The document is as of June 5, 2017 unless otherwise noted.
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.
- Bitcoin Shop is one of the first publicly traded companies focused on the virtual currency ecosystem. It operates an ecommerce platform that accepts bitcoin and other cryptocurrencies as payment.
- The company is developing its BTCS 2.0 platform to expand its product offerings and vendor base. It aims to build a virtual currency ecosystem through ecommerce.
- Bitcoin Shop has a experienced management team with expertise in capital markets, technology, and the virtual currency industry. It plans to grow its customer base and monetize through additional service offerings.
This document discusses Genius Brands International and its business model of providing children's entertainment content across multiple platforms. It notes that animated content has enduring appeal across generations and borders. It highlights Genius Brands' existing properties like Baby Genius which have had success on television and other platforms. The document outlines Genius Brands' plans to expand these properties to new distribution channels internationally and through new merchandise programs. It also presents several new animated series concepts in development. Biographies of the Chairman and CEO Andy Heyward and another executive emphasize their experience in children's entertainment.
Digiplex is a growing movie theater circuit focused on acquiring and improving theaters. It currently owns 19 theaters with 184 screens across 6 states. Digiplex aims to grow its footprint to 100 theaters and 1,000 screens located primarily in top markets. The company pursues an acquisition strategy of purchasing cash flow positive theaters at reasonable multiples. It also seeks to increase theater utilization and revenue through alternative programming events. Digiplex is led by an experienced management team with deep industry expertise.
Oragenics is developing novel antibiotics and probiotics through synthetic biology collaborations. For antibiotics, they are focusing on lantibiotics, a class of naturally produced antibacterial peptides, with a lead compound called MU1140 showing promise against MRSA, VRE and C. difficile. For probiotics, they are engineering bacteria to produce and deliver therapeutics locally for oral diseases. Their OTC probiotic product ProBiora3 supports oral health currently. Upcoming milestones include animal studies on MU1140 in 2014 and generating genetically modified probiotic prototypes in 2014-2015.
This document discusses Biocept, Inc., a commercial-stage cancer diagnostics company. It provides an overview of Biocept's liquid biopsy platform and tests, including OncoCEE-BR, their first commercialized test for breast cancer. The document also summarizes Biocept's growth strategy, which includes expanding their test menu, improving operational efficiency, and increasing market penetration. It introduces Biocept's executive team and describes their extensive experience in cancer diagnostics, genomics, and life sciences.
This document contains forward-looking statements and disclaimers about InterCloud's financial projections and business strategies. It notes that actual results could differ from what is presented due to various risk factors. It also states that the pro forma financial information provided is constructed from separate financial statements of the companies involved and does not necessarily represent what the combined financials would be. The document provides an overview of InterCloud, describing its cloud platforms and services, growth strategies, key metrics like revenue and EBITDA, value propositions for investors and customers, examples of professional services case studies, comparative financial statements, and backgrounds of the key executives.
Profire Energy is an oilfield technology company that specializes in burner management systems (BMS). [1] It was founded in 2002 in Alberta, Canada and is now headquartered in Utah with operations throughout North America and Brazil. [2] BMS automate combustion processes, improving safety and efficiency for oil and gas companies by quickly reigniting burner flames when failures occur. [3] While the market for BMS is large due to over 1.3 million oil and gas wells in North America, it remains served by only a few companies. Profire Energy seeks to expand its product offerings and distribution network to capture more of this growing market.
Energy Fuels is a uranium mining and milling company with operations in the United States. It currently produces 500,000 pounds of uranium per year and has the goal of increasing production to over 5 million pounds annually as market conditions improve. Energy Fuels owns numerous uranium projects throughout the Western U.S. and operates the only conventional uranium mill in the country. The company is pursuing a strategy of low-cost production while conserving capital and maintaining production optionality for the future.
This document provides an overview of Vaccinogen and its cancer vaccine OncoVAX. OncoVAX is designed to reduce the risk of cancer recurrence after surgery and has shown statistically significant results in reducing recurrence in phase 3 trials for stage 2 colon cancer. Vaccinogen has completed 5 clinical studies involving over 750 patients and is in the final stages of clinical development. OncoVAX represents a potential $5 billion market opportunity in the US and Europe for treating colon and other cancers. The manufacturing process for OncoVAX is straightforward and scalable.
The document discusses accounts payable (AP) transformation and how moving from a paper-based to digital process can provide benefits. It outlines common problems with paper-based AP like high costs and lack of visibility. The solution presented is an end-to-end AP automation platform that handles invoice receipt, approval workflows, payments and spend management. Key benefits highlighted include lower processing costs, improved staff efficiency, and enhanced supplier relationships.
This document discusses forward-looking statements and risks for Akers Biosciences, Inc. It notes that any statements regarding future financial performance, development of products and services, or opportunities should be considered forward-looking. Actual results may differ due to risks in development, clinical trials, need for capital, and intellectual property maintenance. The document also provides brief biographies of ABI's experienced management team and board.
The presentation summarizes Clean Coal Technologies' business and technology. It discusses the company's management team and strategic partnerships. It then provides an overview of the growing global demand for coal and issues with existing coal, before detailing CCTI's patented coal upgrading processes. The presentation outlines the technology, its benefits over alternatives, the planned commercial rollout and compelling projected plant economics.
Hangw/ is a global, mobile social media platform that allows users to connect and share live video broadcasts. It has grown rapidly since launch, with over 250,000 downloads and millions of user sessions. The platform generates revenue by showing ads before, during, and after live broadcasts, and shares a portion of ad dollars with broadcasters. Celebrities, athletes, and other influencers use Hangw/ to interact directly with their fans.
Exeo Entertainment, Inc. is a manufacturing company concentrating on developing innovative products that fill a clearly defined need in today’s interactive entertainment industry. Featured products include the Zaaz™ smart TV keyboards, Patented Psyko Krypton™ 5.1 gaming headphones, Krankz Bluetooth music headphones, an Android® based portable gaming system, and the Extreme Gamer® -the world’s first multi–disc game changer.
Lattice Inc. provides technology services to correctional facilities and has experienced 700% revenue growth from 2009 to 2013. It offers a suite of cloud-based services that provide secure communications and information technology to smaller facilities. Some of its products and services include video visitation, email, music downloads, and an integrated jail management software solution. While it faces competition from larger national service providers, Lattice has a unique technology advantage in both the US and foreign markets it is expanding into. Its integrated corrections operations network platform provides cost reductions and enhanced revenue streams for facilities.
Srne sorrento therapeutics-redchip conference presentation (20140123)-reducedRedChip Companies, Inc.
Sorrento Therapeutics presents its next-generation cancer therapeutics pipeline, including Cynviloq and RTX. Cynviloq is a late-stage paclitaxel product that offers potential advantages over Taxol and Abraxane such as higher dosing. It has demonstrated efficacy in multiple Phase 2 trials and is pursuing an abbreviated regulatory pathway for approval. RTX is a clinical stage non-opiate pain treatment that produces long-lasting analgesia through a single injection by targeting TRPV1 receptors. Sorrento aims to develop multiple products from RTX through intrathecal and intraganglionic injections.
Big North Graphite : Presenting at Global Online CEO Conference Small Stocks...RedChip Companies, Inc.
This document provides an overview of Big North Graphite Corp., a mining company exploring graphite opportunities in Mexico and Canada. It summarizes the management team's experience, the capital structure including shares outstanding and warrants, and key investment highlights. Specifically, it notes Big North is currently selling amorphous graphite in Mexico and aims to restart near-term flake graphite production at its recently acquired El Tejon Flake Graphite Mine and Mill in Oaxaca, Mexico, which was previously operational until 2002. A cautionary note also indicates forward-looking statements may materially differ from expectations.
AV Therapeutics is developing new cancer therapeutics including Capridine, a patented drug that has shown specific activity against prostate cancer in preclinical studies. Capridine addresses an unmet need as it has limited side effects and bone toxicity compared to existing treatments. AV Therapeutics plans to submit an IND application to begin Phase I/II clinical trials for Capridine based on its promising preclinical results showing potency against prostate cancer cells and taxane resistant cell lines with no toxicity to bone marrow cells. The company has a strong management team and scientific advisory board from top institutions to advance its pipeline of safer and more effective cancer treatments.
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.
The document discusses Sanofi and Regeneron's Phase 3 clinical trial program for sarilumab, an investigational IL-6 receptor monoclonal antibody for the treatment of rheumatoid arthritis. The program includes several trials involving over 5,000 patients total to evaluate sarilumab both as monotherapy and in combination with methotrexate or other disease-modifying anti-rheumatic drugs. The two largest trials, MOBILITY and TARGET, enrolled over 1,700 patients and evaluated sarilumab versus placebo for improving signs and symptoms of rheumatoid arthritis and physical function when added to background therapy. Results from these trials demonstrated statistically significant improvements for sarilumab compared to placebo.
- 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.
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.
The FOURIER trial investigated whether adding evolocumab to statin therapy reduces cardiovascular events. Over 27,000 patients with a history of cardiovascular disease were randomized to receive evolocumab or placebo injections in addition to statin therapy. The primary objective was to determine if evolocumab lowered the risk of major cardiovascular events such as heart attack, stroke, and cardiovascular death. Secondary objectives were to examine the long-term safety and tolerability of evolocumab and investigate the efficacy and safety of achieving very low LDL-cholesterol levels. Results from this outcomes trial could provide evidence on whether PCSK9 inhibition translates to clinical benefit for high-risk patients.
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.
Johnson & Johnson Pharmaceutical Business ReviewDeepa K
The document is an agenda for an investor presentation. It outlines the schedule for the day which includes presentations on the company's enterprise overview, pharmaceutical commercial and R&D strategies, and various therapeutic areas. It also includes notices about forward-looking statements and new molecular entities being discussed. The speakers and locations are listed next to each topic.
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 “flair-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.
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.
This document contains forward-looking statements regarding Sanofi's strategic outlook, key growth drivers, and pipeline of potential transformative therapies. It discusses the significant growth potential of Dupixent across type 2 inflammatory diseases, with an ambition to achieve over €10 billion in peak sales. Vaccines are also highlighted as an expected mid-to-high single-digit growth driver through 2025. The pipeline includes potential first-in-class or best-in-class therapies for diseases like multiple sclerosis, respiratory syncytial virus, and breast cancer that could transform patient care if approved.
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.
1) The ODYSSEY OUTCOMES trial evaluated long-term cardiovascular outcomes in patients with a history of acute coronary syndrome (ACS) who were treated with alirocumab (Praluent) or placebo while receiving statin therapy.
2) The trial found that alirocumab reduced the risk of the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization compared to placebo.
3) Additionally, alirocumab was associated with a lower rate of all-cause mortality compared to placebo, representing the first time a non-statin lipid-lowering therapy has demonstrated a reduction in all-cause mortality in a cardiovascular outcomes trial
- PTX has a deep clinical pipeline with 3 ongoing or planned clinical trials, including Phase Ib/II trials of PTX-200 in breast cancer and ovarian cancer, and a planned Phase Ib trial of PTX-100 in AML.
- PTX-200 and PTX-100 are novel cancer drugs targeting the Akt and Ras pathways that have potential to overcome chemotherapy resistance.
- The clinical trials are being conducted at prestigious cancer centers in the US including Moffitt Cancer Center and Albert Einstein College of Medicine.
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 “flair-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.
Can-Fite is developing small molecule drugs that target the A3 adenosine receptor, including Piclidenoson for rheumatoid arthritis and psoriasis, and Namodenoson for liver cancer and NASH. Piclidenoson has shown efficacy in Phase II trials for rheumatoid arthritis and is currently in Phase III trials for rheumatoid arthritis and psoriasis. Namodenoson has shown efficacy in Phase II trials for liver cancer and is preparing for Phase III trials. Can-Fite is also exploring using Piclidenoson for COVID-19 given its anti-inflammatory and potential anti-viral properties.
Prescient Therapeutics (PTX:ASX) is an ASX-listed biotechnology company focused on improving outcomes for cancer patients by developing personal medicines, using CAR-T and targeted therapy approaches.
Universal CAR-T therapies like OmniCAR have the potential to take personalised cancer treatment to the next level, by combining the cancer-killing capabilities of a T-cell with the control and pharmacology of a drug.
Glaukos investor presentation q2 2016 for website 08032016glaukos
Glaukos Corporation is a medical technology company transforming glaucoma treatment. Their solution portfolio includes micro-scale injectable therapies to restore and enhance aqueous outflow including the iStent, iStent Inject, and iStent Supra. Clinical trials show the iStent reduces intraocular pressure and medication use when used with cataract surgery or as a standalone procedure. Glaukos has established global commercial operations and seized the first mover opportunity in key markets since US FDA approval of the iStent.
- The document presents information on Praluent (alirocumab), the first PCSK9 inhibitor therapy approved in the US for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.
- Praluent demonstrated robust and durable LDL-C reduction of over 52 weeks in clinical trials in patients on maximally tolerated statin therapy, with 57-83% of patients achieving sufficient LDL-C reduction with the 75 mg starting dose.
- The Committee for Medicinal Products for Human Use adopted a positive opinion for Praluent in Europe, and approval is expected in late September 2015. The OD
“The Coin Tree is a cloud-based storage, insurance, and payment processing platform for bitcoin that leverages cutting edge transactional security to serve the ever expanding virtual currency community."
StarStream Entertainment is a theatrical motion picture production and financing company focused on producing and financing edgy, high quality motion pictures with strong cast and lean budgets for a commercial audience.
StarStream Entertainment is a theatrical motion picture production and financing company focused on producing and financing edgy, high quality motion pictures with strong cast and lean budgets for a commercial audience.
StarStream Entertainment aims to be a theatrical motion picture production and financing company focused on producing edgy, high quality films with strong casts and lean budgets. It mitigates risk through fiscal precision by financing projects once they are fully developed and ready to produce, offering investors a quicker return. Recent successful films include Lee Daniels' The Butler, Life of Crime, and Life After Beth.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
InterCloud Systems provides cloud-centric solutions and services to enterprises and service providers. Their two main business focus areas are Software Defined Enterprise and Cloud to Cloud Mobility. They help customers modernize infrastructure, develop cloud strategies, and deliver cloud-centric IT visions aligned to business value. InterCloud partners with major cloud platform and solution providers like VMware, OpenStack, and CloudStack.
This presentation provides an overview of SANUWAVE Health Inc., a regenerative medicine company developing non-invasive biological response activation devices. SANUWAVE's lead product, dermaPACE, is in a Phase III FDA trial for treating diabetic foot ulcers and has the potential for approval in 2015 pending positive results. DermaPACE offers a lower-cost, non-invasive alternative to existing wound therapies. If approved, dermaPACE could address the large diabetic foot ulcer market and be expanded to other applications. SANUWAVE completed a $9.3 million capital raise to fund the dermaPACE trial and has 38 patents covering its shockwave technology platform.
Genius Brands International is a company focused on providing children's entertainment content with purpose for toddlers to tweens. It was created through the merger of A Squared Entertainment and Genius Brands. The document discusses Genius Brands' plans to grow its portfolio of animated properties like Baby Genius, Warren Buffett's Secret Millionaires Club, and new shows in partnership with Stan Lee and Martha Stewart. It aims to distribute this content across television, online, mobile and through a new streaming service, while supporting the content through consumer products licensing. The management team, including Andy and Amy Heyward, have decades of experience in the children's entertainment industry.
StationDigital is a digital media and ecommerce platform that allows users to stream or access any media and purchase digital and physical goods from any device. It has grown rapidly since its public beta launch in 2013, achieving over 1.3 million mobile users. The presentation outlines StationDigital's mission and growth strategy, competitive advantages over other media companies, and large market opportunity in digital media and ecommerce. It argues that StationDigital is well positioned for continued growth and market share capture.
DRONE Aviation Corp (DRNE) was formed in April 2014 to penetrate the rapidly growing Unmanned Aerial Systems (UAS) business in U.S. and abroad for government and commercial customers.
DRNE’s mission is to aggressively penetrate the expanding Drone market with our unique Tethered Drones, which are currently being fielded to the U.S. Department of Defense and State and Local municipalities.
DRNE owns and operates Florida-based Lighter Than Air Systems Corp (LTAS), a developer and supplier of unique and specialized aerial solutions to the U.S. Government, State municipalities, and commercial entities.
InterCloud Systems Incorporated is a single - source provider of end - to - end IT technology and telecom solutions to the ent erprise, service provider, and g overnment markets through “Cloud Platforms” and professional services. “Cloud Comput ing”, is defined as the use of computing resources (compute, NTK, Storage) that are delivered as a managed service over a network. InterCloud offers its service provider custo mers the ability to utilize “cloud” solutions inside their existing network footp rint as well as in a “white label environment” so it can offer a suite of cloud products under their own brand, delivered over the broadband services it presently sell s . ICLD’s cloud services include infrastructure as a service (IaaS), platform as a servi ce (PaaS), and software as a service (SaaS) .
This document provides an overview of Actinium Pharmaceuticals, Inc. and summarizes their proprietary alpha particle immunotherapy technology and product pipeline. Key points include:
1) Actinium has a pipeline of targeted radiotherapy candidates using alpha emitters to treat various blood cancers. Their lead candidate, Iomab-B, is being developed for conditioning blood cancer patients prior to bone marrow transplant.
2) Iomab-B has shown promising results in clinical trials, successfully preparing older refractory AML patients for transplant who otherwise would not be eligible. Actinium has FDA agreement to advance Iomab-B into a Phase III registration trial.
3) Actinium has a proprietary technology
The nuclear energy industry has lain stagnant for over 30 years and has suffered from missteps and perception issues.
Lightbridge is here to innovate and change the conversation. About: Lightbridge is a U.S. nuclear energy company based in McLean, Virginia with operations in Abu Dhabi, Moscow and London. The Company develops proprietary, proliferation resistant, next generation nuclear fuel technologies for current and future nuclear reactor systems. The Company also provides comprehensive advisory services for established and emerging nuclear programs based on a philosophy of transparency, non-proliferation, safety and operational excellence. Lightbridge's breakthrough fuel technology is establishing new global standards for safe and clean nuclear power and leading the way to a sustainable energy future. Lightbridge consultants provide integrated strategic advice and expertise across a range of disciplines including regulatory affairs, nuclear reactor procurement and deployment, reactor and fuel technology and international relations. The Company leverages those broad and integrated capabilities by offering its services to commercial entities and governments with a need to establish or expand nuclear industry capabilities and infrastructure.
Richfield Oil & Gas Company (OTCQX: ROIL) is an independent exploration and production company headquartered in Salt Lake City, Utah. The Company’s current oil production flows from wells in fields located in Kansas and Wyoming. In addition to several thousand acres in Kansas, Richfield also owns strategically-located exploratory leases in central Utah on trend to major oil discoveries.
American Water provides water and wastewater services to approximately 14 million people in 16 states, has a market capitalization of $8.6 billion, and seeks to continue growing its regulated water business through capital investments and acquisitions while also expanding its complementary market-based business lines. The company has delivered strong total shareholder returns since its 2008 IPO and maintains a transparent dividend policy aimed at increasing its dividend in line with normalized earnings per share growth.
Direct Insite (“DIRI”) provides cloud-based, ERP-agnostic solutions that automate Accounts Payable (AP) and Accounts Receivable (AR) invoice processes for Global 3000 companies. Their solutions include invoice validation, order matching, consolidation, dispute handling and e-payment processing. DIRI helps clients eliminate manual processes and costs associated with doing everything on paper. By migrating from paper to electronic, DIRI can reduce transactions costs 50-70% and reduce time by 80%. Current clients include Siemens, HP, IBM, Saint-Gobain, Shell Oil, and Hyatt with a Global vendor network of 350,000+ suppliers.
Lattice Incorporated (“Lattice” or the “Company”), founded in 1973, provides secure communications and information technology, specializing in deploying advanced technology and services to create innovative, cost - effective solutions for the Company’s global customers. The Company provides both wholesale and direct services to correctional facilities and their service providers in the U.S., Canada and Europe. Expansion of Lattice’s direct and wholesale services, including increased techno logy equipment and software sales to wholesale customers, is expected to drive revenue growth and increased margins in the quarters ahead
Quadrant 4 Systems Corporation is a leading provider in of health exchange platforms, innovative software products and proprietary SMAC (social media, mobility, analytics and cloud computing) solutions to enterprise clients in Retail and Manufacturing, Media and Publishing, Financial Services and Health Care sectors.
Energy Fuels is the nation's leading conventional uranium producer, supplying approximately 25% of the uranium produced in the U.S. (based on FY-2013 deliveries). The Company also has the capability to be a significant producer of vanadium. Energy Fuels owns and operates the White Mesa Mill, which is the only conventional uranium mill currently operating in the U.S. The mill is capable of processing 2,000 tons per day of uranium ore and producing up to 8 million lbs. of U3O8 per year (depending on ore grade).
This document provides a safe harbor statement and background information on VeriTeQ Corporation. It discusses forward-looking statements and risks associated with investment. It then provides an overview of the company, including its founding, acquisitions, regulatory clearances, and financing activities. Key areas of focus for the company are discussed, including medical device UDI/identification and biosensing/radiation dosimetry technologies. Leadership and intellectual property are also summarized.
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During the budget session of 2024-25, the finance minister, Nirmala Sitharaman, introduced the “solar Rooftop scheme,” also known as “PM Surya Ghar Muft Bijli Yojana.” It is a subsidy offered to those who wish to put up solar panels in their homes using domestic power systems. Additionally, adopting photovoltaic technology at home allows you to lower your monthly electricity expenses. Today in this blog we will talk all about what is the PM Surya Ghar Muft Bijli Yojana. How does it work? Who is eligible for this yojana and all the other things related to this scheme?
Ellen Burstyn: From Detroit Dreamer to Hollywood Legend | CIO Women MagazineCIOWomenMagazine
In this article, we will dive into the extraordinary life of Ellen Burstyn, where the curtains rise on a story that's far more attractive than any script.
AI Transformation Playbook: Thinking AI-First for Your BusinessArijit Dutta
I dive into how businesses can stay competitive by integrating AI into their core processes. From identifying the right approach to building collaborative teams and recognizing common pitfalls, this guide has got you covered. AI transformation is a journey, and this playbook is here to help you navigate it successfully.
Unlocking WhatsApp Marketing with HubSpot: Integrating Messaging into Your Ma...Niswey
50 million companies worldwide leverage WhatsApp as a key marketing channel. You may have considered adding it to your marketing mix, or probably already driving impressive conversions with WhatsApp.
But wait. What happens when you fully integrate your WhatsApp campaigns with HubSpot?
That's exactly what we explored in this session.
We take a look at everything that you need to know in order to deploy effective WhatsApp marketing strategies, and integrate it with your buyer journey in HubSpot. From technical requirements to innovative campaign strategies, to advanced campaign reporting - we discuss all that and more, to leverage WhatsApp for maximum impact. Check out more details about the event here https://events.hubspot.com/events/details/hubspot-new-delhi-presents-unlocking-whatsapp-marketing-with-hubspot-integrating-messaging-into-your-marketing-strategy/
The Most Inspiring Entrepreneurs to Follow in 2024.pdfthesiliconleaders
In a world where the potential of youth innovation remains vastly untouched, there emerges a guiding light in the form of Norm Goldstein, the Founder and CEO of EduNetwork Partners. His dedication to this cause has earned him recognition as a Congressional Leadership Award recipient.
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The Role of White Label Bookkeeping Services in Supporting the Growth and Sca...YourLegal Accounting
Effective financial management is important for expansion and scalability in the ever-changing US business environment. White Label Bookkeeping services is an innovative solution that is becoming more and more popular among businesses. These services provide a special method for managing financial duties effectively, freeing up companies to concentrate on their main operations and growth plans. We’ll look at how White Label Bookkeeping can help US firms expand and develop in this blog.
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Enhancing Adoption of AI in Agri-food: IntroductionCor Verdouw
Introduction to the Panel on: Pathways and Challenges: AI-Driven Technology in Agri-Food, AI4Food, University of Guelph
“Enhancing Adoption of AI in Agri-food: a Path Forward”, 18 June 2024
NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
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2. 2
This presentation contains forward-‐‑looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 concerning our plan to issue our securities, our product candidates, our
development efforts, our technology, our intellectual property, our financial condition, our plans and
our development programs. These forward-‐‑looking statements involve risks, uncertainties and
assumptions and are based on the current estimates and expectations of future events by the
management of Ruthigen, Inc. as of the date of this presentation and are subject to a number of risks
and uncertainties that could cause actual results to differ materially and adversely from those indicated
in or implied by such forward-‐‑looking statements. Given these uncertainties, you should not place
undue reliance on these forward-‐‑looking statements.
These risks and uncertainties include, but are not limited to: the possibility that clinical trials will not be
successful or confirm earlier results, risks associated with obtaining funding from third parties, risks
relating to the timing and costs of clinical trials, approvals for clinical trials, results of clinical trials, the
timing of regulatory submissions, the timing and receipt of regulatory approvals, the timing and
amount of other expenses, execution risks, competition, risks related to 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, future financial results and other factors set
forth under the headings “Cautionary Note Concerning Forward-‐‑Looking Statements,” “Risk Factors”
and “Management'ʹs Discussion and Analysis of Financial Condition and Results of Operations” in the
prospectus described in this presentation. All statements contained in this presentation are made only
as of the date of this presentation and Ruthigen undertakes no obligation to update or revise publicly
any forward-‐‑looking statements, whether as a result of new information, future events, or otherwise,
unless required by law.
FORWARD-‐‑LOOKING STATEMENTS
3. 3
Ruthigen, Inc. (“Ruthigen”, “we”, “our”, “us”, or the “Company”) is providing this presentation,
which highlights basic information about us and the offering to which this communication relates.
Because it is a summary, it does not contain all of the information that you should consider before
investing in our securities. We have filed a registration statement, including a prospectus, with the U.S.
Securities and Exchange Commission (SEC) for the offering. The registration statement has not yet
become effective. Before you invest, you should read the preliminary prospectus in the registration
statement, including the risk factors described therein, and other documents we have filed as exhibits
to the registration statement with the SEC for more complete information about us and the offering.
You may access these documents for free by visiting the EDGAR page on the SEC web site, which can
be found at hbp://sec.gov. The preliminary prospectus, dated March 12, 2014, is available on the U.S.
Securities and Exchange Commission web site at hbp://www.sec.gov. Alternatively, the Company or
any underwriter participating in the offering will arrange to send you the prospectus and/or any
supplements thereto if you contact Dawson James Securities, Inc., Abention: Prospectus Department, 1
North Federal Highway, 5th Floor, Boca Raton, FL 33432, e-‐‑mail: mmaclaren@dawsonjames.com or toll
free at (866) 928-‐‑0928.
FREE WRITING PROSPECTUS STATEMENT
4. 4
RUTHIGEN MISSION
Design therapeutics to improve patient lives, redefine infection control for invasive
procedures and deliver cost savings to hospitals
5. 5
RUTHIGEN IS A DRUG DEVELOPMENT COMPANY
• First to develop and potentially market a HOCl
(hypochlorous acid) drug candidate for invasive use
! Proven efficacy with lower concentration
formulation against standard of care antibiotic
! Plan to initiate Phase 1/2 for safety and efficacy in
July 2014
• Targeting large unmet need
! Antibiotics not effective in prevention of
infections after surgery
! $700M initial market; $3B surgical market
• Market driven by hospital economics
! ACA: Pay for performance
! Hospital not reimbursed for patients re-‐‑admibed
within 30 days after discharge
! Potential to accelerate patient discharge after
surgery, reduce post-‐‑surgical infection rates, and
decrease hospital readmission rates
• Well established mechanism of action that is used in
neutrophils and evolved to fight pathogens
! RUT58-‐‑60 destroys a broad spectrum of pathogens
including MRSA/VRE & viruses
6. 6
RUT58-‐‑60 COMPARISON TO MICROCYN
Hypochlorous
Acid-Based
Field of Use
U.S. FDA
Regulatory
Path
Small Molecule
Stabilizers
Biocompatible
With Internal
Organs
Sterile
Packaged
Relative
Concentration
RUT58-60
"
Invasive
Drug
"
"
"
3x
Microcyn
"
Topical
Medical
Device
#
#
#
1x
7. 7
SELECT PUBLISHED ARTICLES USING MICROCYN
(HOCl)
• Landsman, et al; JAPMA 2010*
! An Open-‐‑Label, Three-‐‑Arm, Pilot Study of the Safety and Efficacy of Topical Microcyn Rx Wound
Care Versus Oral Levofloxacin Versus Combined Therapy for Mild Diabetic Foot Infections
! Study demonstrated a statistic significant improvement in infections at day 24 after treatment in
patients with mild diabetic foot ulcers
! Oculus Phase 2 study
• Khairulasri, et al; The Heart Surgery Forum 2010**
! Dermacyn Irrigation in Reducing Infection of a Median Sternotomy Wound
! 178 patients who underwent elective coronary artery bypass graft (CABG) surgery had their
wounds washed with Dermacyn or 10% povidone-‐‑iodine solution. On average, 5.7% of the patients
washed with Dermacyn and 15.6% of the patients with iodine showed a sternal infection (p=0.033).
* Oculus Sponsored study
** Oculus provided product at no cost for the purposes of the study
8. 8
PHASE 2 DATA SUMMARY WITH MICROCYN (HOCl)
# Patients Percent # Patients Percent # Patients Percent
Day 10
Clinical Success (Primary Endpoint) 14 78% 11 61% 14 70%
Cure 6 33% 7 39% 8 40%
Improvement 8 44% 4 22% 6 30%
Clinically Evaluable Population 18 18 20
Day 24
Clinical Success (Follow-Up Visit) 14 93% 9 56% 15 83%
Cure 10 67% 5 31% 10 56%
Improvement 4 27% 4 25% 5 28%
P value
Clinically Evaluable Population 15 16 18
p = 0.033
Clinical Cure or Improvement of Infection at Days 10 and 24
Saline + Levofloxacin Microcyn + LevofloxacinMicrocyn (Monotherapy)
• Oculus reported results of the Landsman, et al Phase 2 study using HOCl with patients
diagnosed with Diabetic Foot Ulcers
! Microcyn arms improved from day 10 to day 24
! Study design: randomized, prospective, multicenter, open-‐‑label study to evaluate the
safety and efficacy of Microcyn treatment for mildly infected diabetic foot ulcers
9. 9
SURGICAL STUDIES WITH MICROCYN (HOCl)
• Khairulasri, et al; The Heart Surgery Forum 2010
! Dermacyn Irrigation in Reducing Infection of a Median
Sternotomy Wound
! 178 patients who underwent elective coronary artery
bypass graft (CABG) surgery had their wounds washed
with Dermacyn or 10% povidone-‐‑iodine solution. On
average, 5.7% of the patients washed with Dermacyn
and 15.6% of the patients with iodine showed a sternal
infection (p=0.033).
10. 10
STANDARD OF CARE HAS SEVERE LIMITATIONS
• Current standard of care is systemic antibiotics plus saline
! Antibiotic resistant strain of bacteria remain a top concern for hospitals – e.g. MRSA,
VRE, others
! Administrators not satisfied with current long hospital stays / discharge times and high
re-‐‑admission rates
• Significant need to combat hospital acquired infections (HAIs) and improve hospital
economics
! Pace of innovation for new antibiotic drugs has slowed
! Antibacterial resistance is emerging at a faster pace
! Traditional new therapies targeted similar mechanism of actions and thus only keep
bacterial resistance one step behind innovation
• RUT58-‐‑60 vs. Antibiotics:
Broad Range
Anti- Infective
Addresses
Resistance
Concerns
Reduce
Hospital
Stays
Pro-
Healing
RUT58-60
"
"
"
"
Antibiotics
#
#
#
#
11. 11
ANTIBIOTIC RESISTANCE HISTORIC TIMELINE
• The time to the emergence of antibiotic resistance in select bacteria has accelerated. Data
below is from the CDC report titled: “Antibiotic Resistance Threats in the United States, 2013”
! From the 1940s through the 1980s, average time to resistance exceeded 10 years
(excluding penicillin). The average time to resistance is now approximately 1 year
!
1940
1950
1960
1970
1980
1990
2000
2010
2020
penicillin
tetracyline
erythromycin
methicillin
gentamicin
vancomycin
imipennem
ceftazidime
levofloxacin
linezolid
daptomycin
ceftaroline
Year Introduced
Year Resistance Developed
12. 12
SIGNIFICANT UNMET MEDICAL NEED
• $3.3 billion* spent annually for treatment of surgical site infections, representing
approximately 33.7% of the total annual cost of hospital acquired infections in the U.S.
• Total economic cost of antibiotic resistance to the U.S. economy has been estimated to be as
high as $35 billion, including approximately $20 billion in direct healthcare costs, as
reported in a 2013 CDC report**
• Concerns remain high regarding the emergence of new antibiotic-‐‑resistant organisms
despite more recent reports showing a stabilization or decline in these rates
! (56% in 2006/2007 -‐‑ CDC)
• Hospital reimbursement challenges
! Affordable Care Act
! Overall reimbursement tied to infection rates
! Pay for performance
! 30-‐‑day readmission rule
* JAMA Intern Med. Published online September 02, 2013.
** “Antibiotic Resistance Threats in the United States, 2013”; CDC September 2013
13. 13
LARGE ADDRESSABLE MARKET
• $3B-‐‑plus Market. We estimate the addressable market in the U.S. to be approximately $3.0
billion to $4.5 billion, based upon an estimated 30 million patients that undergo advanced
surgical interventions each year
! 30 million patients represent only those patients in each surgical category that may
benefit from RUT58-‐‑60
• $700M-‐‑plus Abdominal Market. We estimate the abdominal surgical market represents a $700
million – plus market opportunity in the U.S. annually
• WHO estimated in 2008 that over 230 million surgical procedures
were undertaken worldwide on an annual basis
• Additional target markets within surgical and
traumatic injury include: Pulmonary, Cardiovascular,
Orthopedic, and Spinal surgery
14. 14
UNIQUE DRUG FORMULATION
• RUT58-‐‑60 is designed to meet FDA requirements as a drug candidate:
! Hypochlorous acid (HOCl) drug candidate with small molecule stabilizers including
magnesium and no hypochlorite
! Stability
! Invasive use: compatibility with internal organs
! Sterile packaging
• Developed Through Evolution. HOCl, the active agent in RUT58-‐‑60, is a compound that is
created by neutrophils and other cells in the body'ʹs immune system
• Production of HOCl by human cells:
15. 15
RUT 58-‐‑60 ADVANTAGES
• Hospital Drivers:
! Hospitals seeking new products to reduce rates of
hospital acquired infections (HAIs) and to control costs.
! Health care reimbursement moving towards a ‘pay for
performance’ model
! Potential to reduce risk of high unreimbursed cost
associated with patients with hospital acquired
infections
● Safety Drivers:
! RUT58-‐‑60 is similar to the HOCl produced by the body.
● Clinical Drivers:
! Broad spectrum, effective against antibiotic resistant
strains, MRSA, VRE.
! Potentially for prophylactic use because it does not
promote resistance
! Potential for accelerated patient discharge
16. 16
RUT58-‐‑60 MECHANISM OF ACTION
• HOCl found in RUT58-‐‑60 cross-‐‑links critical
bacterial biomolecules on cell surfaces through a
fast-‐‑acting oxidation reaction
! Reactive with proteins (sulzydryl groups
and amino groups) and unsaturated bonds
in lipids. HOCl is identified as an inhibitor of
sulfur and hydrogen bond known as
sulzydryl critical to bacterial survival
! Irreversible damage to bacteria, viruses and
fungi. Low molar ratios of HOCl to bacterial
protein causes oxidative protein unfolding in
vitro while HOCl targets bacterial proteins
for irreversible aggregation in vivo
! Increases bacterial cell membrane
permeability
! Interrupts ATP production – responsible for
cellular energy storage and transfer
17. 17
● RUT58-‐‑60 has 20 times the concentration of HOCl shown in the graph below
● Induces bacterial cell destruction but remains well within the dosage required for tissue
safety and compatibility
HOCl POTENCY COMPARED TO OTHER OXIDATIVE
AGENTS
O.1 mM* has shown to be the effective dose to
induce bacterial cell death
* Bonvillain RW et al in 2011
18. 18
RUT58-‐‑60 SAFETY MECHANISM IN MAMMALIAN CELLS
* Journal of Drugs in Dermatology, Volume
12, issue 1, 2013
** Journal Exp Ther Ocol, 2011;9(2):93-‐‑100
• The presence of amino acid Taurine in mammalian cells is responsible for the scavenging
activity and neutralization of HOCl*
• Pure forms of stable HOCl has shown improved antimicrobial, therapeutic and safety index
profile as compared to disinfectants, hydrogen peroxide and sodium hypochlorite*
• RUT58-‐‑60 provides the benefits of HOCl without the harmful side effects of Myeloperoxidase
(MPO-‐‑ carcinogenic at high concentrations in vivo) required for production of HOCl in the
mammalian cells**
19. 19
IN-‐‑VITRO KILL TIMES
• Select Pathogen Activity of RUT58-‐‑60
Bacteria Challenge! Contact Times (Log Reductions)! % Bacterial! Incubation*!
Populations ! 30 Sec! 1 Min! 2 Min! 5 Min! 10 Min! Reduction**! Times (hrs)!
MRSA (Methicillin-resistant S. aureus)!
8.5! 8.5! 8.5! 8.5! 8.5! 99.9999997%! 24.5!
E. coli!
8.4! 8.4! 8.4! 8.4! 8.4! 99.9999996%! 24!
P. aeruginosa!
8.2! 8.2! 8.2! 8.2! 8.2! 99.9999993%! 25!
VRE (E. faecalis)!
8.1! 8.1! 8.1! 8.1! 8.1! 99.9999993%! 24!
P. mirabilis`!
8.3! 8.3! 8.3! 8.3! 8.3! 99.9999995%! 57!
S. marcescens!
8.8! 8.8! 8.8! 8.8! 8.8! 99.9999999%! 24.5!
C. albicans!
7.1! 7.1! 7.1! 7.1! 7.1! 99.9999929%! 22.5!
* Incubated on TSA (Tryptic Soy Agar) at 30-35C!
** Calculations show no detectable surviving bacterial presence in the samples tests. Test methods did not use serial dilutions"
21. 21
CLINICAL STRATEGY: U.S. & INTERNATIONAL
● United States:
! Ruthigen plans to initiate its Phase 1/2 clinical trial in the U.S. in July 2014
! Proposed clinical trial protocol includes two arms, test (RUT58-‐‑60) and control (systemic antibiotics
with saline wash).
! Antibiotics:
! up to 24 hrs prior: Neomycin + (Erythromycin or Metronidazole)
! up to one hr prior: Cefoxitin or Cefazolin + (Metronidazole or Ertapenem) or Clindamycin +
(Gentamicin or Aztreonam or Ciprofloxicin) or Metrondazole + (Gentamicin or Ciprofloxacin)
! 150 patients enrollment target, 1:1 ratio
! Short patient follow-‐‑up periods (weeks vs. years)
! Clinical trial design previously reviewed by FDA
! Regulatory path qualifies under 505(b)1
● International:
! Seek partnerships to fund RUT58-‐‑60 development and commercialization in Europe, Japan, and
Canada
22. 22
PHASE 1/2 CONTROLLED, RANDOMIZED, DOUBLE
BLINDED TRIAL DESIGN
Patients will receive pre-surgical systemic antibiotics per standard of care !
At the conclusion of surgery patients will receive 1st microbiological swab"
"
All patients undergo final microbiological collection from abdominal
wall. Incisions are closed and surgery is concluded"
2nd Lavage !
400 mL saline + swab"
2nd Lavage !
400 mL RUT58-60 + swab"
RUT58-60 Group (n=75)"Control Group (n=75)"
1st Rinse!
400 mL saline + swab"
1st Rinse!
400 mL RUT58-60 + swab"
Final Rinse!
100 mL saline"
Final Rinse!
100 mL RUT58-60"
23. 23
PHASE 1/2 CLINICAL TRIAL DESIGN
Primary End Points: Assess the Safety and Efficacy of RUT58-‐‑60 in Post-‐‑Surgical Infection in
Subject Undergoing Abdominal Surgery
Exploratory End Points: Overall length of hospital stay, Re-‐‑admission rate (30 days)
Adverse Events: Nausea/Vomiting, Pain, Fever, Ileus1, SSI2 (Superficial, Deep, Organ)
1 Ileus: absence of bowel sounds and/or delay of return of bowel function
2 Surgical Site Infection
Surgery
• An+bio+c
Prophylaxsis
• Microbiologic
Culture
• Adverse
Events
Day
7
• Clinical
Signs
&
Symptoms
• Adverse
Events
Day
14
• Clinical
Signs
&
Symptoms
• Adverse
Events
Day
28
• Clinical
Signs
&
Symptoms
• Adverse
Events
24. 24
INTELLECTUAL PROPERTY
• Ruthigen has licensed its intellectual property and know-‐‑how from Oculus for invasive use
! Ruthigen is licensing the technology to develop a new formulation of HOCl for invasive
applications
! 37 issued (5 U.S., 32 foreign) patents licensed with claims covering:
! Chemical composition
! Apparatus
! Method of manufacturing
! Therapeutic uses
! 99 pending applications (15 U.S., 84 foreign)
! License to future improvements and patents filed by Oculus on HOCl technologies
! Patent protection beyond 2030
! 2009 federal court ruling found patents enforceable (OCLS vs. NOFIL Corp.)
25. 25
TALIZATION
(as
of
5/21/13)
Post-‐IPO
SHARES
(*)
Post-‐IPO
%
OUTSTANDING
Oculus Owned Ruthigen Shares
2,000,000
48%
Common Shares Issued in IPO
2,200,000
52%
Shares Outstanding Immediately
Post-‐‑IPO
4,200,000
100%
Shares Underlying Series A Warrants
2,200,000
Shares Underlying Series B Warrants
2,200,000
Shares Underlying Representative
Warrants
110,000
Total Potential Shares Outstanding
8,710,000
CAPITALIZATION STRUCTURE
* Does not include 330,000 shares and/or Series A Warrants associated with the over-‐‑allotment
option, 901,740 shares of our common stock reserved for future issuance under our 2013
Employee, Director and Consultant Equity Incentive Plan, or 2013 Plan, of which restricted
stock units for up to 523,740 shares of our common stock are intended to be granted to our
employees and directors on the 46th day after the completion of this offering.
26. 26
SELECT ANTI-‐‑INFECTIVE COMPANY COMPARABLES
* Valuation as of 3/10/14
Company Name Therapeutic Focus Development Status Valuation
Ruthigen, Inc. Prevention of Infection Phase 1/2 (Post-IPO) ~$35M
Tetraphase TTPH Antibiotics Phase 3 $317M
SIGA Technologies SIGA Anti-virals IND $180M
Durata Therrpeutics DRTX Antibiotics, MRSA Phase 3 $379M
Synthetic Biologics SYN Biologics, Anti-infectives Phase 2 $125M
Cellceutix CTIX Cancer / Antibacterial Phase 1 / Phase II $195M
Insmed Inc. INSM Inhaled antibiotic Phase 2 $696M
KalaBios Pharmaceuticals KBIO Respiratory Disease, Cancer Phase 2 $111M
Cempra CEMP Anti-infectives Phase 3 $372M
Chimerix CMRX Anti-virals Phase 2 $518M
Anacor Pharmaceuticals ANAC Derm, Anti-infectives Phase 3 $826M
Optimer Pharmaceuticals - Anti-infectives Commercial
$801M ($551M upfront)
Cubist acq.
Trius Therapeutics - Anti-infectives NDA
$818M ($704M upfront)
Cubist acq.
27. 27
NEAR-‐‑TERM VALUE CREATION MILESTONES
IND Submission
April 2014
Phase 1/2 Initiation
July 2014
Phase 1/2 Interim Review
3Q 2014
Phase 1/2 Results
1Q 2015
Complete Manufacturing Transfer
2H 2014
Phase 2b / Pivotal Initiation
2Q 2015
• Near-‐‑term calendar year milestones
28. 28
INVESTMENT SUMMARY
● First to develop and potentially market pharmaceutical grade HOCl
● Well established mechanism of action that evolved in human neutrophils:
! RUT58-‐‑60 destroys a broad spectrum of pathogens including MRSA/VRE & viruses
● Targeting large unmet medical needs with economic driven adoption curve
! Addresses hospital need to prevent HAIs and reduce costs associated with infections.
! $700M initial market; $3B-‐‑plus potential surgical market
! Potential to accelerate patient discharge after surgery, reduce post-‐‑surgical infection
rates, and decrease hospital readmission rates after surgery
● Well defined clinical path
! Plan to file IND in April 2014 and initiate clinical trials in July 2014
! Abdominal surgery is a large market and a “dirty” surgery; provides high impact
opportunity for initial indication
● Strong intellectual property portfolio in-‐‑licensed
● Management team experienced with HOCl development and drug trials