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.
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.
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.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
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®.
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.
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.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
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.
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.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
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®.
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.
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.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
Reviva Pharmaceuticals Holdings Inc is a clinical development pharmaceutical company. It is developing a portfolio of internally discovered therapies that address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases.
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®.
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
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies for inflammatory and infectious diseases. Their lead program, IMM-124E, is in Phase 2 trials for NASH, ASH, and pediatric NAFLD, with interim data expected in 3Q 2017 and full results by 4Q 2017. IMM-124E has shown positive preclinical data, demonstrating a reduction in liver fibrosis, inflammation, and metabolic markers. Immuron also has a drug candidate, IMM-529, in development for C. difficile infection, expected to begin Phase 1/2 trials in 2Q 2017.
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.
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.
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.
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.
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.
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.
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.
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.
Lantern Pharma leverages AI, machine learning and genomic data to transform oncology drug development. Their RADR platform identifies patient subgroups likely to respond to drug candidates to increase success rates. They are developing multiple oncology drug programs including LP-100 for prostate cancer through a precision trial. LP-300 targets never-smoker NSCLC adenocarcinoma based on prior data and biomarker studies. Lantern aims to reduce costs and time through AI-enabled approaches.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
Immuron Limited is a clinical-stage biopharmaceutical company targeting inflammatory and infectious diseases with oral immunotherapies. It has two lead clinical assets in Phase 2 development for fatty liver disease and C. difficile infection. It also has a registered and revenue-generating Travelan product targeting traveler's diarrhea. The company is listed on the NASDAQ and ASX exchanges and has an experienced management team supported by key opinion leaders. It is well positioned to address significant unmet needs in liver disease and infectious disease markets with blockbuster potential. Near-term milestones include interim data readouts from multiple Phase 2 NASH and pediatric NAFLD trials in 2017-2018.
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
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.
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
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
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.
Reviva Pharmaceuticals Holdings Inc is a clinical development pharmaceutical company. It is developing a portfolio of internally discovered therapies that address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases.
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®.
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
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies for inflammatory and infectious diseases. Their lead program, IMM-124E, is in Phase 2 trials for NASH, ASH, and pediatric NAFLD, with interim data expected in 3Q 2017 and full results by 4Q 2017. IMM-124E has shown positive preclinical data, demonstrating a reduction in liver fibrosis, inflammation, and metabolic markers. Immuron also has a drug candidate, IMM-529, in development for C. difficile infection, expected to begin Phase 1/2 trials in 2Q 2017.
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.
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.
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.
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.
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.
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.
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.
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.
Lantern Pharma leverages AI, machine learning and genomic data to transform oncology drug development. Their RADR platform identifies patient subgroups likely to respond to drug candidates to increase success rates. They are developing multiple oncology drug programs including LP-100 for prostate cancer through a precision trial. LP-300 targets never-smoker NSCLC adenocarcinoma based on prior data and biomarker studies. Lantern aims to reduce costs and time through AI-enabled approaches.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
Immuron Limited is a clinical-stage biopharmaceutical company targeting inflammatory and infectious diseases with oral immunotherapies. It has two lead clinical assets in Phase 2 development for fatty liver disease and C. difficile infection. It also has a registered and revenue-generating Travelan product targeting traveler's diarrhea. The company is listed on the NASDAQ and ASX exchanges and has an experienced management team supported by key opinion leaders. It is well positioned to address significant unmet needs in liver disease and infectious disease markets with blockbuster potential. Near-term milestones include interim data readouts from multiple Phase 2 NASH and pediatric NAFLD trials in 2017-2018.
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
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.
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
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
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.
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
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.
Soligenix is a late-stage biopharmaceutical company specializing in developing and commercializing products to treat rare diseases with unmet medical needs. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™, a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and is now negotiating a confirmatory Phase 3 pivotal study design with the US Food & Drug Administration, while also evaluating/pursuing potential HyBryte™ marketing approval ex-U.S. with the successfully completed Phase 3 study.
Soligenix is a late-stage biopharmaceutical company specializing in developing and commercializing products to treat rare diseases with unmet medical needs. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™, a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and is now negotiating a confirmatory Phase 3 pivotal study design with the US Food & Drug Administration, while also evaluating/pursuing potential HyBryte™ marketing approval ex-U.S. with the successfully completed Phase 3 study.
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.
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.
Aridis Pharmaceuticals is advancing multiple clinical stage monoclonal antibodies (mAbs) targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients.
- 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.
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.
Progenity (PROG) Investor Presentation - Nov 30, 2021ssuser6da871
This corporate presentation discusses the company's therapeutics pipeline and programs. The company is developing oral delivery of biotherapeutics using an Oral Biotherapeutics Delivery System to enable needle-free delivery of large molecules. It is also developing GI-targeted therapeutics using a Drug Delivery System to deliver drugs directly to the gastrointestinal tract for improved efficacy and safety. Several product candidates are discussed, as well as potential catalysts and market opportunities for the different programs.
BiondVax's next generation flu vaccine is in late Phase 2 human clinical trials. Designed to offer multi-season protection against all seasonal and pandemic influenza, results from 5 completed trials have shown safety and immunogenicity. Learn More: www.biondvax.com.
Exact Sciences Corp. announced that the company continued its strong performance during the third quarter ended Sept. 30, 2015, completing 34,000 Cologuard tests, an increase of 60 percent from the second quarter, which resulted in $12.6 million in revenues. The cumulative number of ordering physicians grew to 21,000 during the quarter, an increase of 42 percent.
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
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.
Exact Sciences is becoming the leader in advanced cancer diagnostics by extending its Cologuard platform to next-generation liquid biopsy cancer diagnostics. Cologuard addresses the challenge of colorectal cancer screening by providing a non-invasive, easy-to-use test with high early-stage cancer sensitivity. Cologuard's commercial success is driven by expanding insurance coverage, growing physician adoption, and direct-to-consumer marketing campaigns.
Ctxr presentation mid-size_02.22.2019_spring.finalScott Martin
This 3-page corporate presentation by Citius Pharmaceuticals provides an overview of their investment opportunity and pipeline. Their lead product Mino-Lok is in Phase 3 trials for treating central line-associated bloodstream infections (CLABSI) and has the potential to salvage infected central venous catheters rather than requiring removal. They have a Phase 2 product for hemorrhoids and a pre-clinical product for preventing breast implant infections. The presentation highlights the large market opportunities and management team's experience advancing 505(b)(2) products.
Similar to Aridis Investor Presentation 2022 Q1 (20)
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Docola has developed a healthcare communication platform that utilizes asynchronous telehealth to deliver patient education and support. Their proprietary platform currently has over 55,000 patient users and over 1,100 clinician users. Docola seeks to raise up to $500,000 through a convertible note to fund working capital, research and development, and costs associated with an upcoming IPO.
- INNO Holdings is presenting an IPO investor presentation for an initial public offering on the NASDAQ Capital Market.
- The company manufactures prefabricated steel building components and systems using proprietary technology to reduce construction costs and environmental impact.
- INNO Holdings has four initial product lines - metal studs, prefabricated housing units, modular apartment buildings, and a mobile factory system. It aims to disrupt the construction industry through standardized, sustainable construction methods.
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a biotech company developing immune monitoring and immune modulation platforms. Its AditxtScore platform can provide comprehensive immune profiles to monitor responses to pathogens, vaccines, drugs and transplants. Its Adimune platform aims to modulate the immune system to treat conditions like psoriasis, type 1 diabetes, and increase skin allograft survival. The company is working to develop, operate and commercialize these platforms. It currently generates revenue from immune monitoring tests and expects revenue from licensing deals for immune modulation programs as they advance in clinical trials towards commercialization.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
2. 2
Forward Looking Statement
These forward-looking statements relate to future events or future financial performance of the
Company. All such forward-looking statements involve risks and uncertainties and are not guaranties
of future performance. An investment in the securities of Aridis is speculative in nature, involves a
high degree of risk, and should not be made by an investor who cannot bear the economic risk of its
investment for an indefinite period of time and who cannot afford the loss of its entire investment.
These include many important factors that affect our ability to achieve our stated objectives including,
but not limited to:
We operate in a very competitive and rapidly changing environment. New risks emerge from time to
time. It is not possible for our management to predict all risks, nor can we assess the impact of all
factors on our business or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking statements we may make. In
light of these risks, uncertainties and assumptions, the forward-looking events and circumstances
discussed in this presentation may not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking statements.
*
*
The timing of regulatory submissions;
Our ability to obtain and maintain regulatory approval of our existing product candidates and any
other product candidates we may develop, and the labeling under any approval we may obtain;
Approvals for clinical trials may be delayed or withheld by regulatory agencies;
Pre-clinical and clinical studies will not be successful or confirm earlier results or meet expecta-
tions or meet regulatory requirements or meet performance thresholds for commercial success;
The timing and costs of clinical trials, the timing and costs of other expenses;
Our ability to obtain funding from third parties;
Management and employee operations and execution risks;
Loss of key personnel;
Competition;
Market acceptance of products;
Intellectual property risks;
Assumptions regarding the size of the available market, benefits of our products, product pricing,
timing of product launches;
The uncertainty of future financial results;
Risks associated with this offering;
Our ability to attract collaborators and partners;
Our reliance on third party organizations.
Except as required by law, neither we nor any other person assumes responsibility for the accuracy
and completeness of the forward-looking statements. We undertake no obligation to update publicly
any forward-looking statements for any reason after the date of this presentation to conform these
statements to actual results or to changes in our expectations.
*
*
We have filed a registration statement (including a prospectus) with the Securities and Exchange
Commission ("SEC") for the offering to which this communication relates. Before you invest, you
should read the prospectus in the registration statement and other documents we have filed with the
SEC for more complete information about us and this offering. You may get these documents for free
by visiting EDGAR on the SEC web site at http://www.sec.gov.Alternatively, we, any underwriter, or
any dealer participating in the offering will arrange to send you the prospectus if you request it from
Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY
10022; email: prospectus@cantor.com. This presentation shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.
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3. 3
Corporate Summary
Late clinical stage company with two (2) Phase 3 assets
▪ First-in-Class & first-line treatment [AR-301] and prevention [AR-320] of acute pneumonia
▪ ~$1 Billion market opportunities
▪ Strong Phase 2 clinical data in patients, supporting safety & efficacy
Near-term clinical data readouts in three (3) clinical programs [within 9-12 months]
Seasoned management team
4. 4
Employing Human Monoclonal Antibody for Infections
mAb
Toxins
Monoclonal
Antibody (mAb)
Antibiotics
Virus
Bacteria
Benefits of mAbs: Targeted, Durability of action, Predictable safety
5. 5
Product Pipeline
Next
Milestone
Targets IND Phase 1 Phase 2 Phase 3
Products Pre-Clinical
Phase 3
data 2H2022
AR-301 mAb
(tosotoxumab)
Gram (+) Bacteria
S. aureus a -toxin
Pneumonia Treatment
Phase 3
Global launch
1H2022
AR-320 mAb
(suvratoxumab)
Gram (+) Bacteria
S. aureus a-toxin
Pneumonia Prevention
AR-501
(Panaecin)
Gram (-) & (+)
Iron Pathways
Phase 2a data
1H2022
Cystic Fibrosis
AR-701
mAb
COVID-19 Virus
Spike Protein
Phase 1/2a
1H2022
COVID-19
tbd
Gram (-) Bacteria
A. baumannii
AR-401
mAb
Bacteremia
6. 6
Healthcare Burden of S. aureus Bacterial Infections
~252,000 ICU patients
US claims database (2018)*
Survey of 30 cases (median)
n=201
Hospital
Days
n=394
In-Patient
Costs
Hospital
Pharmacy
Laboratory
44.4%
21.0%
16.3%
60 days $220,000
37.9
40 days
Respiratory Treatment (Mech. ventilation)
Radiology (+CT Scans)
Cardiology
9.3%
3.3%
1.9%
$110,000
20 days
7.2 Operating Room
Diagnostics (Blood ECG)
1.4%
1.9%
Control Staph Control Staph
Pulmonary Diagnostic
Orthopeadic
0.4%
0.3%
ICU stay 1.1 day 6.9 days 1.1 day 6.9 days
All Cause
Mortality
3% 16% 3% 16% Restrepo (2010) ICHE 31:509-515
*Kyaw MH et al., 2015 BMC Health Serv Res. 15:241
$146,978
$33,851
7. 7
$6 Billion Market for S. aureus HAP/VAP
Estimated $6 billion annual healthcare cost burden attributable to S. aureus nosocomial pneumonia3
AR-301 adressable patient population: 648,0001 AR-320 adressable patient popl’n ~1.8 million2
Breakdown
of Strains
52%
48%
Potential S. aureus HAP/VAP Patients by Market1
*Sources
337,500 1
2
Paling FP, BMC Infect Dis. 2017;17(1):643
Francois, B. et al. Lancet Inf. Dis. 2021;
https://doi.org/10.1016/S1473-3099(20)30995-6
Warren DK, Outcome and Attributable Cost of VAP among ICU
patients in a suburban medical center, Critical
Care Med 2003;31(5):1312-7.
3
Lifecycle opportunities include surgical site, skin/skin structure, UTI, and BSI infections due to S. aureus
U.S.A. 222,750
Europe
Japan 87,750
MRSA
MSSA
8. 8
AR-301 & AR-320
Mechanism of Action:
Interstitium
Normal
Alveolus
Alveolar
air
space
TargetsS. aureus α-Toxin
Type 1 cells
Staphyllococcus
aureus
Macrophages
α-toxins
Anti-toxin monoclonal
antibody approach is a
proven MOA, e.g.
mAb
PMN
Necrosis
α-toxins
attacking
immune cell
Commercialized:
α-toxins
Intact
immune cell C. Difficile mAb Bezotoxumab (MRK)
Anthrax mAb Raxibacumab (GSK-
EBSI)
Gram (+) bacteria: S. aureus
Host cells killed by α-toxins*
T-cells
Pneumoncytes
Endothelial cells
Red blood cells
Neutrophils
Macrophages, Monocytes
*Toxins 2013, 5(6), 1140-1166
10. 10
5,000 mg
750 mg
AR-320: Favorable Phase 1 & 2 PK and Safety Data
Exceptionally long plasma half-life
(T1/2 of 80 to 112 days)
Phase 1 Healthy Adults (n=36)
Few adverse events (AEs) deemed related to AR-320
Suvratoxumab demonstrated a favorable safety
Half-life extension resulted in exceptionally long
exposure, up to one (1) year post-dose
10,000
1,000
100
10
Phase 2 ICU S. aureus Colonized Patients (n=196)
Adverse events (AEs) , SAEs, deaths were balanced
between Placebo and AR-320
Suvratoxumab demonstrated a favorable safety, PK,
and ADA profile
1
360
300
0 60 120 180 240
Time since start of infusion (days)
Mean
Serum
Concentration
(ug/mL)
11. 11
AR-320: Phase 2 ‘SAATELLITE’ Study Completed
▪ Randomized, double blinded, placebo-controlled Phase 2 study in 50 EU & US clinical sites
(conducted by AstraZeneca & EU IMI’s COMBACTE Consortium)
▪ Patient population: Intubated ICU patients colonized with S. aureus bacteria but did not yet have pneumonia
▪ Primary endpoint: Incidence of S. aureus pneumonia* within 30 days post-IV dose (FDA & EMA-negotiated endpoint)
Placebo IV infusion
n = 100
30-Day
Incidence of S. aureus
pneumonia*
S. aureus colonization
confirmation by
PCR,
randomize &
dose n = 96
AR-320 at 5,000mg
IV infusion
*Adjudicated by panel of VAP experts & radiologists who are blinded to the treatment assignment
12. 12
AR-320 Phase 2: Attained Statistical Significance ( < 65yrs old)
Pre-Specified Groups
All subjects
Low S. aureus
(mITT) <65 yrs old 5 VAP bundles**
burden
10
n =196 n =128 n =101 n =72
0
-10
-20
-30
-40
-50
-60
(Phase 3 Target
Population)
-70
p-value
0.069
-80
*p-value < 0.10 is statistically significant per agreement with FDA & EMA, and allowed per FDA Guidance for VAP indication (see FDA Guidance for HAP/VAP, 2013)
**5 VAP Bundles is a clinical outcome improvement assessment (elevation of the head of the bed, daily 'sedation vacation' & daily assessment of readiness to extubate, etc.)
See Francois, B. et al. 2021 Lancet Infectious Diseases
‘mITT’ is microbiological confirmed intend to treat population
Relative
Risk
Reduction
of
S.aureus
Pneumonia
Compared
to
Placebo
(%)
p-value
0.166
p-value p-value
0.075* 0.075*
13. 13
Net Difference compared to Placebo
40 Hospitalization
days
Mechanical
ventilationdays
ICU days
35
0
-1
-3
-5
-7
-9
-11
30
25 1.9 days
20
15
10
8.8 days
Hospitalization days ICU days Mechanical
ventilationdays
Placebo AR-320
Healthcare
Utilization
(Mean
days)
3.3 days
30.3
20.0
16.7
14.6
12.7
Healthcare
Utilization
(Mean
days)
39.1
AR-320 Phase 2: Pharmacoeconmic outcomes for
the Phase 3 target population (<65 yrs old)
14. 14
AR-320 Phase 3 ‘SAATELLITE-2’ Trial Design
IV
infusion
n = 282
30-Day
Incidence of all-
cause pneumonia*
S.a. colonization
confirmation by PCR,
randomize & dose
Evaluating the potential of
AR-320 (5,000 mg) to prevent
S. aureus pneumonia vs. placebo
Single confirmatory Phase 3 prior to BLA
Interim futility analysis
in mid-2023 and final data
readout in 1H2024
n = 282
AR-320 at
5,000mg
IV
infusion
*n=564 translates to ~99% power to achieve p<0.05 for the primary endpoint of All-cause Pneumonia. For
secondary endpoint of All-cause Pneumonia or Death, 564 translates to a power of 90%
1-to-1 randomized, double-blind, placebo-
controlled, single dose IV
Targeting 564 patients (12 to 65yrs old)
colonized w/S. aureus (no VAP) across
200 sites in ~20 countries (U.S., EU, Asia)
16. 16
AR-301: Therapeutic Treatment of Acute Pneumonia
Superiority Trial Design
VS.
AR-301
Standard
of Care
Standard
of Care
With positive data, provides for value-based premium reimbursement
Antibiotics alone Adjunct therapy
17. 17
AR-301 Phase 2a: Trial Recently Completed
Randomized, double-blind, placebo-controlled, single ascending dose of AR-301
31 sites across EU and U.S.
Design
Patient Selection 48 patients with HAP or VAP caused by S. aureus
Groups SOC [antibiotics alone] + Placebo n=16
n= 6
n= 8
n=10
n= 8
SOC + AR-301
SOC + AR-301
SOC + AR-301
SOC + AR-301
(1 mg/kg )
(3 mg/kg)
(10 mg/kg)
(20 mg/kg)
Safety and pharmacokinetics
Primary Endpoint
Hospitalization days
All-cause mortality
Clinical cure rate
Secondary Endpoint Time to removal of ventilator (VAP patients)
Microbiological cure
Shorter time to eradication
Days in ICU
Data trend in favor of adjunctive treatment benefit
Francois, B. et al. 2018 Intensive Care Medicine
18. 18
Phase 2
Aggregated AR-301 treated VAP groups
exhibited lower probability of requiring
mechanical ventilation vs. placebo.
Francois, B. et al. 2018 Intensive Care Medicine.
Probability
of
Receiving
Mechanical
Ventilation
100%
80%
60%
40%
20%
0 5 10 15 20 25
Days on Mechanical
Ventilators
improvement
+AR-301 Pooled (n=20)
Antibiotics alone (n=5)
50%
AR-301 Phase 2 Efficacy: Time on Mech. Ventilation
19. 19
1-to-1 randomized, double-blind,
placebo-controlled, single dose I.V.
Evaluating the potential of
adjunctive AR-301 (20 mg/kg) to
SOC antibiotics vs. antibiotics alone
Targeting 240* patients with VAP
caused by S. aureus across 125
sites in 20 countries (U.S., EU, Asia)
Broad
spectrum
antibiotics
n = 120
Day 21
Test of
Clinical
Cure**
Randomize
& Treat
n = 120
Broad
spectrum
antibiotics
AR-301 at 20 mg/kg
IV infusion
Top-line data expected 2H2022
**Sample size at 90% power (p<0.05) [20% absolute effect size]: n=138
*Dependent on extent of COVID-19 related ICU utilization
AR-301 Phase 3 (on-going): Trial Design
(ClinicalTrials.gov ID NCT03027609)
Primary endpoint of clinical
cure rate at day 21
Placebo buffer
IV infusion
20. 20
AR-301 Phase 3: Powering Calculation and Assumptions
Primary Endpoint: Clinical Cure Rate
Study
Power
80%
90%
Control
(SOC)
AR-301
+ SOC
Absolute
Difference
mITT
per group
Total
Enrolled
(p<0.05)
75%
75%
95%
95%
20%
20%
n = 55
n = 69
n = 110
n = 138
Phase 3 enrollment target = 240 patients*
(i.e. over-powered versus n=138 patients to achieve superiority in primary endpoint)
*Dependent on extent of COVID-19 related ICU utilization
‘mITT’ is microbiologically confirmed intent to treat population
21. 21
Covering Prevention and Treatment of S.a. HAP/VAP
Projecting $1Bn+ market opportunity for each candidate
AR-320
Suvratoxumab
Prevention
Lung colonized, high risk but
does not yet have VAP
AR-301
Tosatoxumab
Treatment
Confirmed infection
ventilator-assoc. pneumonia
*Assumptions: MRSA-only VAP, 60% adoption rate due to first-line, $10,000 per regimen
**S. aureus colonized, intubated, without VAP symptoms, $5,000 per regimen, 15% adoption rate
Total
Sales
($millions)
AR- 320
$2,500
Total
$2,000
$1,500
AR-301*
$1,000
AR-320**
AR-301
approval
$500
approval
$0
2022 2024 2026 2028 2030 2032 2034 2036 2038
22. 22
AR-501: Novel Inhaled Non-Antibiotic
Small Molecule Anti-infective
Mechanism of Action
Iron (Fe) is necessary for bacterial metabolic
functions. AR-501 (gallium, Ga) replaces Fe
Ga
Gallium
AR-501 impairs multiple bacterial functions,
while standard antibiotics inhibit single targets
23. 23
AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients
CF Foundation Funded
Phase 1 Healthy Volunteers Phase 2 Cystic Fibrosis Patients
(on-going)
PARI eFlow
nebulizer
Done
Single Ascending Dose
6 mg 20 mg 40 mg Multiple Ascending Doses
t = 0, 1, 2 weeks
18 patients
AR-501
6 patients
Placebo 6 mg 20 mg 40 mg
Primary Endpoint:
Safety and PK
Secondary Endpoints:
Lung function of CF patients (changes in
FEV1)
Sputum bacteriology
30 patients
AR-501
15 patients
Placebo
Done
Multiple Ascending Doses
t = 0, 1, 2, 3, 4 weeks
6 mg 20 mg 40 mg
Ph2a data readout: mid-22
18 patients
AR-501
6 patients
Placebo
Ph1 study results: AR-501 was well tolerated
24. 24
A single IV dose of gallium resulted in statistical
significant improvement in lung infection
Proxy Data:
Safety & Efficacy of
IV Gallium
Demonstrated
Intent to Treat Population CF
Patients
10%
8%
6%
4%
2%
0%
-2%
-4%
-6%
Inhaled
Delivery
mg/mL
Gallium
300
1
Day
6
Days
14
Days
28
Days
56
Days
Gallium
Placebo
60
59
60
57
58
57
Patients
60
56
Patients
59
56
Patients
Patients
Patients
2
Data from University of Washington: Goss, C. et al.
2018 N. Am. Cystic Fibrosis Conference Abstract #307 (*estimate based on animal PK data)
Mean
Relative
Change
from
Baseline
in
FEV1
(L)
Sputum
concentration
Inhaled
(est.)
IV
25. 25
AR-701: COVID-19 mAb Cocktail for I.M. & Inhalation
– Broad, pan-coronavirus cocktail utilizing dual mechanism of action
• Effective against Omicron, more future-proof against SARS-COV2 variants
• Effective against SARS, MERS, seasonal human coronaviruses
– Efficacious in ACE2 & hamster challenge models
– Intramuscular and Inhaled formulation options
– Long-acting, mAbs are half-life extended
– Targeting non-hospitalized COVID population with self-administered, at-
home treatment
– Phase 1/2 data in 2H2022
Self-administered
inhaled formulation
option
26. 26
Key Milestones: Multiple clinical data readouts in 2022
2023
2022
Q1 Q4
Q3
Q3 Q4 Q1
Q2 Q2
Phase 3
Data
AR-301
Toxin Blocker
AR-320
Toxin Blocker
Phase 3
Initiation
AR-501
Cystic Fibrosis
Phase 2a
Data
Phase 2/3
Data
AR-701
COVID-19
Phase 1/2
Data
27. 27
lPEXTM
Monoclonal Antibody Discovery &
Production Platform Technology
CRISPR
Guided
Integration
Convalescent
COVID-19
patient
PEXTM
Nanoarrays
B-cell repertoire
screening
B-cell
Selected
Cloned CDRs
or H&L of IgG’s
B.R.E.A.T.H. TM
CHO cell line
GMP
Manufacturing
PEXTM
Discovery, Development, and Manuf. 12-15 months potential time saving
TRADITIONAL: Discovery, Development, and Manufacturing
0 3 6 9 12 15 18 21 24 27
Months
Y
Y
28. 28
Financial Information
As of 9/30/2021
▪ Cash & Cash Equivalents
▪ Q3Burn
▪ Shares Authorized
▪ Shares Outstanding
$18.2m
$ 8.7m
100m
14,054,036
Analyst Coverage
▪ Cantor Fitzgerald (Louise Chen)
▪ HC Wainwright ( Vernon Bernadino)
▪ ROTH Capital (Jonathan Aschoff )
▪ Maxim Group (Jason MacCarthy)
▪ Northland Securities (Carl Byrnes)
29. 29
Senior Management
Hasan Jafri
Chief Medical Officer
(AstraZeneca/Medimmune)
Vu Truong
CEO, Director
(Medimmune, Aviron)
Fred Kurland
Chief Financial Officer
(XOMA, PDL, Aviron)
Steve Chamow
VP, Development
(Genentech, Abgenix)
Elizabeth Leininger
VP, Regulatory & Quality
(FDA, GSK, Chiron/Novartis)
Franco Merckling
SVP, Operations
(Eli Lilly, Eisai, Merck)
30. 30
Board of Directors
Eric Patzer, Ph.D.
Chairman
(Co-Founder, Aridis)
Robert Ruffolo, Ph.D., D.Sc.
(Former President Wyeth/Pfizer)
Craig Gibbs, Ph.D., M.B.A.
(Commercial Gilead; Genentech)
Vu Truong, Ph.D.
(CEO, Aridis)
Susan Windham-Bannister, Ph.D.
(Assoc. Women in STEM, Mass. Life Sci. Ctr)
John Hamilton, M.B.A.
(CFO, Depomed; BioMarin)