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.
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.
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.
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.
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services for cancer evaluation. IDXG operates two CLIA-certified labs and has four proprietary molecular diagnostic tests for pancreatic cysts and thyroid nodules that assess cancer risk. The tests have high margins and barriers to entry due to reimbursement and complexity. Recent accomplishments include raising funds, improving financials, expanding insurance coverage and launching international distribution. The molecular diagnostic market is large and growing due to advantages over drug development. IDXG's tests establish new standards in cancer risk assessment for pancreatic cysts and thyroid nodules compared to current guidelines.
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.
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.
EcoStim is an oilfield services company providing well stimulation services in the US and Argentina. The presentation highlights:
1) EcoStim has secured multiple new contracts in 2017 anchoring a second crew in the US and a long-term contract in Argentina, positioning it for accelerated growth.
2) EcoStim trades at an attractive valuation compared to peers based on enterprise value per hydraulic horsepower.
3) EcoStim utilizes proprietary downhole diagnostic and predictive technologies to more efficiently target completion stages, reducing costs for customers.
- Catasys provides an integrated virtual healthcare program called OnTrak that uses predictive analytics and outreach to identify and enroll high-cost members with behavioral health issues.
- OnTrak provides a 52-week treatment program that combines medical, pharmacological and psychosocial treatments to reduce costs by an average of 50% for enrolled members.
- Catasys has national agreements with several leading health plans covering over 7.5 million lives and is currently enrolling participants in 18 states.
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.
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.
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.
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services for cancer evaluation. IDXG operates two CLIA-certified labs and has four proprietary molecular diagnostic tests for pancreatic cysts and thyroid nodules that assess cancer risk. The tests have high margins and barriers to entry due to reimbursement and complexity. Recent accomplishments include raising funds, improving financials, expanding insurance coverage and launching international distribution. The molecular diagnostic market is large and growing due to advantages over drug development. IDXG's tests establish new standards in cancer risk assessment for pancreatic cysts and thyroid nodules compared to current guidelines.
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.
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.
EcoStim is an oilfield services company providing well stimulation services in the US and Argentina. The presentation highlights:
1) EcoStim has secured multiple new contracts in 2017 anchoring a second crew in the US and a long-term contract in Argentina, positioning it for accelerated growth.
2) EcoStim trades at an attractive valuation compared to peers based on enterprise value per hydraulic horsepower.
3) EcoStim utilizes proprietary downhole diagnostic and predictive technologies to more efficiently target completion stages, reducing costs for customers.
- Catasys provides an integrated virtual healthcare program called OnTrak that uses predictive analytics and outreach to identify and enroll high-cost members with behavioral health issues.
- OnTrak provides a 52-week treatment program that combines medical, pharmacological and psychosocial treatments to reduce costs by an average of 50% for enrolled members.
- Catasys has national agreements with several leading health plans covering over 7.5 million lives and is currently enrolling participants in 18 states.
This document is an investor presentation by Pressure BioSciences, Inc. discussing the company's Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PBI has developed instruments and consumables for pressure cycling technology (PCT), which uses alternating cycles of hydrostatic pressure to rapidly and reproducibly lyse cells and tissues to prepare samples for analysis.
- PCT addresses limitations in current sample preparation methods, providing a multi-billion dollar market opportunity. Over 275 PCT systems have been installed worldwide.
- Recent achievements include eliminating debt, releasing a next-generation instrument, collaborating with SCIEX, and expected revenue growth from new products and expanded sales team.
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.
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.
Cancer Genetics reported on its Q4 and full year 2016 earnings. Key highlights included 50% revenue growth in 2016 to $27 million, driven by increases in biopharma, clinical, and discovery services. The company realized operational efficiencies through integration of acquisitions, reducing expenses. However, the company reported a net loss of $15.8 million for 2016. In Q4 2016, revenue increased 32% to $7.2 million while expenses decreased, though the company reported a net loss of $2.8 million. Additionally, Cancer Genetics completed a $12 million debt refinancing to repay existing debt and access additional capital.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Biosceptre is developing targeted cancer therapies directed at the nfP2X7 receptor, which is found in many cancer types but not healthy tissue. They have three drug candidates in clinical trials: BIL03s, a systemic antibody; BIL06v, a peptide vaccine; and BIL010t, a topical antibody for skin cancer. Biosceptre seeks to raise £25M for further development and has an experienced leadership team and intellectual property protecting its platform until the early 2030s.
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 healthcare costs by improving patient outcomes and lowering emergency room visits and hospitalizations. Catasys contracts with health insurance plans to provide OnTrak and is paid a monthly fee per enrolled patient.
This document provides an overview of Cancer Genetics, Inc. (CGI) and their focus on being an oncology diagnostics partner from bench to bedside. Some key points:
- CGI utilizes targeted acquisitions and collaborations with research institutions to expand their testing capabilities and global footprint.
- They have a proprietary portfolio of over 20 genomic tests and panels focused on cancers like blood cancers, lymphomas, lung cancer, and solid tumors.
- CGI partners with leading biopharma companies, supporting over 120 clinical trials with testing and services. They have contracts with 8 of the top 10 biopharma companies.
Catasys provides an integrated behavioral health program called OnTrak that identifies high-cost individuals with behavioral health issues and engages them in a 52-week treatment program. Catasys uses predictive analytics to identify eligible members from claims data provided by health plans. OnTrak reduces medical costs by about 50% and provides a 3-to-1 return on investment for health plans. Catasys expects $20 million in billings in 2018 based solely on its existing pool of eligible members.
SpectraScience's WavSTAT® Optical Biopsy System uses light-based fluorescence spectroscopy to diagnose cancer in the colon during colonoscopy procedures. It is currently in late-stage European clinical trials and poised to commence sales in Europe initially targeting colorectal cancer screening. Studies have found the technology could increase colonoscopy's ability to correctly identify non-cancerous tissue to around 96%. Crystal Research Associates published a 48-page report analyzing SpectraScience and its WavSTAT technology, market opportunities in colorectal cancer screening, competitive advantages, growth strategies and leadership team.
Catasys provides integrated treatment solutions to health plans to improve member health and lower costs. It focuses on members with behavioral health conditions who rarely seek treatment. Catasys utilizes predictive analytics, telehealth, and human engagement to deliver virtual, scalable programs. It has signed contracts with major health insurers and expects $20 million in billings in 2018 based on its existing pool of eligible members. Catasys addresses challenges around access to care, reimbursement, lack of evidence-based practices, and low treatment rates for behavioral health conditions.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
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.
Exas august 2017 corporate presentation finalExact Sciences
This corporate presentation discusses Exact Sciences' mission to help eradicate colon cancer through early detection. It summarizes the company's Cologuard test, which detects colorectal cancer through a non-invasive stool DNA test. The presentation outlines Cologuard's clinical validation and notes it is included in major guidelines. It also reviews Exact Sciences' commercial strategy of increasing awareness, access, and compliance through a sales force, marketing campaigns, and focus on improving health outcomes. Financial results for the second quarter of 2017 show increased revenue and cash on hand compared to the prior quarter.
This corporate presentation from Target: infinite Hope outlines their lead product candidate MDNA55 for the treatment of cancers with Interleukin-4 Receptor (IL4R) biomarker expression. MDNA55 has shown promising clinical efficacy in recurrent glioblastoma patients in Phase 1/2 trials with an objective response rate of 34%. The presentation highlights the significant market opportunity for MDNA55 in brain cancers, which affect over 133,000 patients annually. Target: infinite Hope is pursuing accelerated approval for MDNA55 in recurrent glioblastoma in 2018 based on its Phase 2b trial and end of Phase 2 meeting with the FDA. The company has a pipeline of next-generation IL4-empowered cytokines and $14.
Exas may 2017 corporate presentation final1Exact Sciences
Exact Sciences is developing a pipeline of cancer diagnostic tests based on its methylation technology platform. It has validated methylation markers for the detection of lung, liver, and pancreatic cancers from blood samples, achieving sensitivity of 91-95% and specificity of 90-97%. The company's goal is to apply its platform to screen for and monitor additional cancers through liquid biopsy tests to enable earlier detection and guide treatment decisions. Exact Sciences reported first quarter 2017 revenues of $48.4 million, up from $35.2 million in the previous quarter, demonstrating accelerating adoption of its Cologuard colorectal cancer screening test.
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.
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.
1) Immuron conducted a clinical trial of its drug IMM-124E for the treatment of non-alcoholic steatohepatitis (NASH). The trial showed the drug was well-tolerated and significantly reduced serum endotoxin/lipopolysaccharide levels compared to placebo.
2) The trial also found statistically significant reductions in key liver enzymes (ALT and AST) in patients receiving IMM-124E compared to placebo, indicating reduced liver damage. Additional NASH biomarkers were also reduced.
3) However, the drug did not affect liver fat levels. Overall the results validate IMM-124E's mechanism of action targeting endotoxins and demonstrate its potential for treatment
This document is an investor presentation by Pressure BioSciences, Inc. discussing the company's Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PBI has developed instruments and consumables for pressure cycling technology (PCT), which uses alternating cycles of hydrostatic pressure to rapidly and reproducibly lyse cells and tissues to prepare samples for analysis.
- PCT addresses limitations in current sample preparation methods, providing a multi-billion dollar market opportunity. Over 275 PCT systems have been installed worldwide.
- Recent achievements include eliminating debt, releasing a next-generation instrument, collaborating with SCIEX, and expected revenue growth from new products and expanded sales team.
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.
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.
Cancer Genetics reported on its Q4 and full year 2016 earnings. Key highlights included 50% revenue growth in 2016 to $27 million, driven by increases in biopharma, clinical, and discovery services. The company realized operational efficiencies through integration of acquisitions, reducing expenses. However, the company reported a net loss of $15.8 million for 2016. In Q4 2016, revenue increased 32% to $7.2 million while expenses decreased, though the company reported a net loss of $2.8 million. Additionally, Cancer Genetics completed a $12 million debt refinancing to repay existing debt and access additional capital.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Biosceptre is developing targeted cancer therapies directed at the nfP2X7 receptor, which is found in many cancer types but not healthy tissue. They have three drug candidates in clinical trials: BIL03s, a systemic antibody; BIL06v, a peptide vaccine; and BIL010t, a topical antibody for skin cancer. Biosceptre seeks to raise £25M for further development and has an experienced leadership team and intellectual property protecting its platform until the early 2030s.
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 healthcare costs by improving patient outcomes and lowering emergency room visits and hospitalizations. Catasys contracts with health insurance plans to provide OnTrak and is paid a monthly fee per enrolled patient.
This document provides an overview of Cancer Genetics, Inc. (CGI) and their focus on being an oncology diagnostics partner from bench to bedside. Some key points:
- CGI utilizes targeted acquisitions and collaborations with research institutions to expand their testing capabilities and global footprint.
- They have a proprietary portfolio of over 20 genomic tests and panels focused on cancers like blood cancers, lymphomas, lung cancer, and solid tumors.
- CGI partners with leading biopharma companies, supporting over 120 clinical trials with testing and services. They have contracts with 8 of the top 10 biopharma companies.
Catasys provides an integrated behavioral health program called OnTrak that identifies high-cost individuals with behavioral health issues and engages them in a 52-week treatment program. Catasys uses predictive analytics to identify eligible members from claims data provided by health plans. OnTrak reduces medical costs by about 50% and provides a 3-to-1 return on investment for health plans. Catasys expects $20 million in billings in 2018 based solely on its existing pool of eligible members.
SpectraScience's WavSTAT® Optical Biopsy System uses light-based fluorescence spectroscopy to diagnose cancer in the colon during colonoscopy procedures. It is currently in late-stage European clinical trials and poised to commence sales in Europe initially targeting colorectal cancer screening. Studies have found the technology could increase colonoscopy's ability to correctly identify non-cancerous tissue to around 96%. Crystal Research Associates published a 48-page report analyzing SpectraScience and its WavSTAT technology, market opportunities in colorectal cancer screening, competitive advantages, growth strategies and leadership team.
Catasys provides integrated treatment solutions to health plans to improve member health and lower costs. It focuses on members with behavioral health conditions who rarely seek treatment. Catasys utilizes predictive analytics, telehealth, and human engagement to deliver virtual, scalable programs. It has signed contracts with major health insurers and expects $20 million in billings in 2018 based on its existing pool of eligible members. Catasys addresses challenges around access to care, reimbursement, lack of evidence-based practices, and low treatment rates for behavioral health conditions.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
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.
Exas august 2017 corporate presentation finalExact Sciences
This corporate presentation discusses Exact Sciences' mission to help eradicate colon cancer through early detection. It summarizes the company's Cologuard test, which detects colorectal cancer through a non-invasive stool DNA test. The presentation outlines Cologuard's clinical validation and notes it is included in major guidelines. It also reviews Exact Sciences' commercial strategy of increasing awareness, access, and compliance through a sales force, marketing campaigns, and focus on improving health outcomes. Financial results for the second quarter of 2017 show increased revenue and cash on hand compared to the prior quarter.
This corporate presentation from Target: infinite Hope outlines their lead product candidate MDNA55 for the treatment of cancers with Interleukin-4 Receptor (IL4R) biomarker expression. MDNA55 has shown promising clinical efficacy in recurrent glioblastoma patients in Phase 1/2 trials with an objective response rate of 34%. The presentation highlights the significant market opportunity for MDNA55 in brain cancers, which affect over 133,000 patients annually. Target: infinite Hope is pursuing accelerated approval for MDNA55 in recurrent glioblastoma in 2018 based on its Phase 2b trial and end of Phase 2 meeting with the FDA. The company has a pipeline of next-generation IL4-empowered cytokines and $14.
Exas may 2017 corporate presentation final1Exact Sciences
Exact Sciences is developing a pipeline of cancer diagnostic tests based on its methylation technology platform. It has validated methylation markers for the detection of lung, liver, and pancreatic cancers from blood samples, achieving sensitivity of 91-95% and specificity of 90-97%. The company's goal is to apply its platform to screen for and monitor additional cancers through liquid biopsy tests to enable earlier detection and guide treatment decisions. Exact Sciences reported first quarter 2017 revenues of $48.4 million, up from $35.2 million in the previous quarter, demonstrating accelerating adoption of its Cologuard colorectal cancer screening test.
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.
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.
1) Immuron conducted a clinical trial of its drug IMM-124E for the treatment of non-alcoholic steatohepatitis (NASH). The trial showed the drug was well-tolerated and significantly reduced serum endotoxin/lipopolysaccharide levels compared to placebo.
2) The trial also found statistically significant reductions in key liver enzymes (ALT and AST) in patients receiving IMM-124E compared to placebo, indicating reduced liver damage. Additional NASH biomarkers were also reduced.
3) However, the drug did not affect liver fat levels. Overall the results validate IMM-124E's mechanism of action targeting endotoxins and demonstrate its potential for treatment
This document provides a company presentation by Dan Peres, MD, Senior VP of Innovation at Immuron. It begins with a forward-looking statement noting that certain statements in the presentation are based on estimates and projections and are subject to risks. The presentation then discusses Immuron's oral immunotherapy approach, which aims to alter the systemic immune system using ingestible compounds to target the innate immune system of the gut and promote regulatory T cells to suppress inflammation. Key products in Immuron's pipeline include IMM-124E for fatty liver disease, diabetes, and Clostridium difficile, as well as IMM-529 specifically for Clostridium difficile. The presentation concludes with an overview of Immuron's corporate
- IMM-124E, an oral immunotherapy developed by Immuron, showed promising results in a Phase 2 clinical trial for non-alcoholic steatohepatitis (NASH).
- The trial demonstrated a statistically significant reduction in endotoxin/lipopolysaccharide levels and liver enzymes for patients receiving IMM-124E compared to placebo, indicating its potential as a novel treatment for NASH.
- IMM-529 is Immuron's product candidate for Clostridium difficile infection which has shown in pre-clinical studies to neutralize C. difficile toxins and spores while sparing the gut microbiome, positioning it as a potential best-in-class therapy
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown in preclinical and clinical trials to reduce liver inflammation and fibrosis by binding to LPS (bacterial endotoxin) and promoting regulatory T-cells. Phase 2 trials in NASH are ongoing with results expected in late 2016 to early 2017. Immuron is also developing a vaccine for C. difficile and generates revenues from their traveler's diarrhea drug Travelan. They highlight the significant commercial potential of NASH which is estimated
1) The document contains forward-looking statements about Oncolytics Biotech's financial results, business prospects, and the development of REOLYSIN, noting inherent risks and uncertainties.
2) REOLYSIN is a proprietary reovirus isolate that selectively replicates in and lyses tumor cells with an activated Ras pathway. Over 1,100 patients have been treated with REOLYSIN, demonstrating a strong safety profile and evidence of anti-tumor activity.
3) Clinical studies show REOLYSIN can reduce tumor burden, improve overall survival rates compared to standard therapies, and enhance long-term immune responses against residual tumor cells through viral replication and immune-mediated effects.
1. The presentation discusses a corporate overview of Oncolytics Biotech including their clinical programs investigating REOLYSIN, a proprietary reovirus, as a cancer therapeutic.
2. Data is presented showing REOLYSIN can reduce tumor burden through direct cytotoxic effects and enhance long-term immune responses. Studies also indicate it may improve overall survival.
3. Oncolytics is developing REOLYSIN for registration in muscle invasive bladder cancer based on ability to show histopathological response. They are also investigating its use in gliomas and other cancers.
Corporate Presentation August 24, 2015
1) Oncolytics Biotech is developing the oncolytic virus REOLYSIN® as a cancer therapeutic. REOLYSIN® has shown to selectively replicate in and kill Ras-activated tumor cells while sparing normal cells.
2) Clinical trials involving over 1,100 patients have demonstrated REOLYSIN®'s favorable safety profile and ability to reduce tumor burden and improve overall survival rates.
3) Ongoing randomized phase 2 studies in ovarian, colorectal, breast, lung, and prostate cancers are evaluating REOLYSIN®'s ability to enhance immune responses and improve long-term clinical outcomes.
Immuron Ltd is an Australian biopharmaceutical company focused on immunotherapy using dairy-derived antibody products for humans. Immuron has a unique and versatile technology platform that is capable of generating a wide range of products, all with a high safety profile. The versatility of Immuron’s platform technology enables the development of medicines that target a large range of medical needs, including infectious diseases, immune mediated disorders, and cancers. The versatility is also a function of the dairy origin of Immuron’s antibodies, which enables Immuon to commercialize its platform derived products through a range of regulatory pathways, including prescription (Rx), medical foods, over-the-counter (OTC) medicines, and dietary supplements. The Company has received clearance from the FDA to commence a Phase IIb clinical trial for its NASH product (IMM-124E), a potential blockbuster, in less than three years from commencing its NASH R&D program. Additionally, Immuron has one marketed product (Travelan, for the prevention of travelers’ diarrhea) and a pipeline of products at various stages of clinical and earlier development.
This investor presentation summarizes Oncolytics Biotech's clinical development plan for REOLYSIN, a viral immunotherapy for cancer. It discusses three pathways: 1) chemotherapy combinations, which are the basis for the first registration pathway in pancreatic cancer. Survival data from several phase 2 studies is expected in 2017. 2) Immunotherapy combinations, including an ongoing study of REOLYSIN with pembrolizumab. 3) Targeted agent/IMiD combinations, such as a collaboration using REOLYSIN with pomalidomide in multiple myeloma. The presentation outlines the mechanism of action of REOLYSIN and how combinations can enhance innate and adaptive immune responses against cancer.
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown potential in preclinical and clinical studies to reduce liver inflammation and fibrosis through its anti-LPS and regulatory T-cell promoting properties. They are also developing a vaccine against C. difficile and have an approved traveler's diarrhea drug called Travelan that is generating revenues. Immuron believes they are significantly undervalued given their pipeline, which includes programs targeting large markets like NASH estimated at $35-40 billion by
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- Their portfolio includes collaborations on stem cell-derived retinal pigment epithelial (RPE) cells to treat macular degeneration, and allogenic adult multipotent stem cells to treat inflammatory bowel disease.
- Major challenges for developing and commercializing cell therapies include cell biology and manufacturing complexities, rigorous clinical trial design and supply logistics, and demonstrating a clear business case for pricing and reimbursement.
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This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is a first-in-class immuno-oncolytic virus being developed for solid tumors and blood cancers. It has a dual mechanism of action selectively killing cancer cells while activating the immune system.
- In a phase 2 trial in metastatic breast cancer, REOLYSIN combined with paclitaxel more than doubled overall survival compared to paclitaxel alone in ER+/PR+/HER2- patients.
- The clinical development plan is pursuing combinations with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies. This includes an ongoing myel
Oncolytics Biotech presented their investor presentation which included the following key points:
1) Oncolytics is developing REOLYSIN, a novel immuno-oncology viral agent for systemic administration that exploits cancer cell lysis and anti-tumor immunity.
2) Additional randomized phase 2 clinical trials in 2017 are expected to generate overall survival data in breast cancer, ovarian cancer, non-small cell lung cancer, and colorectal cancer.
3) The clinical development plan focuses on combining REOLYSIN with chemotherapy for late-stage development and establishing it as a backbone agent combined with immunotherapy.
4) Over 900 patients have been treated with REOLYSIN intravenously with no drug
This document provides an overview of Oncolytics Biotech and their lead product, REOLYSIN.
It discusses three clinical development pathways for REOLYSIN: 1) Combinations with chemotherapy to directly lyse tumor cells, 2) Combinations with immunotherapy to activate immune responses, and 3) Combinations with targeted therapies to modulate innate immunity.
For pathway 1, a phase 2 trial showed REOLYSIN in combination with paclitaxel significantly improved overall survival over paclitaxel alone in metastatic breast cancer patients. This provides the basis for a planned 400-patient phase 3 registration study in this indication.
Immuron provided a company update for the first half of 2016. Key developments included reaching 50% recruitment milestones in its Phase 2 NASH trial, initiating a pediatric NASH study, and reporting highly successful pre-clinical data for IMM-529 in treating C. difficile that demonstrated efficacy without antibiotics. The company also started pre-clinical programs in colitis and collaborated with the US Army on a Shigella vaccine. In its OTC business, Immuron expanded its US customer and retail footprint and launched products in China through an e-commerce partnership. Upcoming milestones include reporting interim NASH results in 4Q2016 and initiating the Phase 1 C. difficile trial.
This investor presentation summarizes Oncolytics Biotech's progress developing its lead product REOLYSIN, a proprietary reovirus for treating cancer. Key points include:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial combining it with paclitaxel for metastatic breast cancer.
- The company is preparing for regulatory meetings to discuss a potential registration pathway in breast cancer based on these results.
- Additional clinical studies are investigating REOLYSIN in combination with chemotherapy for pancreatic cancer, immunotherapy with pembrolizumab, and targeted therapies from Celgene.
- REOLYSIN's mechanism of action involves direct killing of cancer cells, stimulation of innate and
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Similar to Immuron Corporate Presentation June 2017 (20)
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1. Immuron Limited
June 2017
Developing Unique Oral Immunotherapies
that Fundamentally Change the Paradigms
of Care
www.immuron.com
ASX:IMC; NASDAQ: IMRN
2. Forward Looking Statement
Certain statements made in this presentation are forward-looking statements
and are based on Immuron’s current expectations, estimates and projections.
Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,”
“estimates,” “guidance” and similar expressions are intended to identify
forward-looking statements.
Although Immuron believes the forward-looking statements are based on
reasonable assumptions, they are subject to certain risks and uncertainties,
some of which are beyond Immuron’s control, including those risks or
uncertainties inherent in the process of both developing and commercializing
technology. As a result, actual results could materially differ from those
expressed or forecasted in the forward-looking statements.
The forward-looking statements made in this presentation relate only to events
as of the date on which the statements are made. Immuron will not undertake
any obligation to release publicly any revisions or updates to these forward-
looking statements to reflect events, circumstances or unanticipated events
occurring after the date of this presentation except as required by law or by
any appropriate regulatory authority.
3. Investment Highlights
3
• Clinical
stage
biopharmaceutical
company
targeting
inflammatory-‐mediated
and
infectious
diseases
with
oral
immunotherapies
• Lead
program,
IMM-‐124E,
in
Phase
2
development
for
the
treatment
of
multiple
high
value
indications,
including
NASH,
ASH
and
Pediatric NAFLD
- NASH
Phase
2
interim
data
expected
3Q
2017
with
topline
results
expected
4Q
2017
- National
Institutes
of
Health
(NIH)
funding
Phase
2
studies
in
ASH
and
pediatric NAFLD
• IMM-‐529,
biologic
with
unique
triple
mechanism
of
action
for
treatment
of
C.
difficile
expected
to
commence
Phase
1/2
study
in
2Q
2017
• Well
positioned
to
address
high
unmet
medical
need
in
multiple
blockbuster
markets
• High-‐value
peer
licensing
deals
and
M&A
underscore
potential
upside
• Company
uplisted to
NASDAQ
in
June
2017
• Experienced Management
Team
and
strong
support
from
leading
KOLs
and
institutions
(NIH,
DoD)
4. Experienced Management Team
4
Thomas Liquard
Chief Executive Officer
Mr. Liquard spent the majority of his career at
Pfizer in New York in various leadership
commercial positions, and was also COO,
then CEO, of Alchemia Limited, an oncology
ASX biotech company.
Dan Peres, MD
Chief Medical Officer
Dr. Peres, a surgeon by training, has deep
experience in liver diseases and clinical
development including NASH, having worked
for leading Medical Devices and Pharma
companies since 2008.
Jerry Kanellos, PhD
COO & Scientific Officer
Dr. Kanellos has over 20 years of experience
in the pharmaceutical and biotech industries
including CMC, operations and BD. He has
held senior roles at CSL and Transbio
Limited.
Reza Moussakhani
Manufacturing Quality Director
Mr. Moussakhani has extensive experience
in implementation of project/quality and
process improvements, including with
Hospira and Sigma Pharmaceuticals.
5. Advisory Board
Dr. Arun Sanyal (MD)
University of Virginia
Former Presidentof the
AASLD. CurrentChair of the
Liver Study Section at the NIH.
IMM-124E lead PI.
Dr. Stephen Harrison (MD)
San Antonio Military Medical Center
Brooke US Army Medical Center
Internationally renowned expert
in NASH. Lead PI of Galectin’s
GR-MD-02’s Phase II trial.
Dr. Manal Abdelmalek (MD)
Duke University Medical Center
Dr. Abdelmalek is a leading
investigator in the field of
NASH.
Dr. Gerhard Rogler (MD, PhD)
Zurich University
Professor Rogler is a leader in
the field of Colitis and has
authored more than 200
original peer-reviewed articles.
Dr. Miriam Vos (MD)
Emory University
Dr. Vos specializes in the
treatment of gastrointestinal
disease in children as well as
fatty liver disease and obesity.
Dr. Dena Lyras (PhD)
Monash University
Dr. Lyras is one of the world’s
leading experts in C. difficile.
5
Organizations
Prominent Scientific Advisory Board and
Leading Research Partners
6. Oral Immunotherapy: Scalable, Disruptive
Technology
6
1
Vaccines Are
Developed
2
Antibodies Are Harvested
from Colostrum
Antigen Specific
Antibodies
(IgG and IgG1)
Adjuvants+
3
Broad Therapeutic Effect
+
• Reduced gut and blood pathogens
responsible for initiating
inflammation
• Reduces systemic inflammation
• Lowers organ injury
• Not associated with general
immune suppression
• Generally Regarded as Safe
(GRAS)
Induction of
regulatory
T-cells
Clearance of
Targeted GUT
Pathogens
Competitive
Advantage
• Platform capable of spawning multiple drugs à Long-term value creation
• Regulated as biologics by the FDA à 12 years exclusivity in the US for each approval
• Significant hurdles to generic biosimilar entry à No pharmacokinetic baseline;Mixture
(e.g., Copaxone)
• Safety established à Generally Regarded As Safe (GRAS)
7. Immuron’s Clinical Programs
Multiple Near-Term Inflection Points
7
Program Indications
Development
Stage
Program
Highlights
Pre-‐Clinical
Phase
1 Phase
2 Phase
3
Anti-‐Inflammatory
Programs
IMM-‐124E NASH
-‐ Interim
data
expected
3Q
2017
-‐ Topline
results
expected
4Q
2017
IMM-‐124E ASH
-‐ NIH
Funded;
UVA
-‐ Topline
results
expected
2018
IMM-‐124E Pediatric
NAFLD
-‐ NIH
Funded;
Emory
University
-‐ Topline
results
expected
1H
2018
IMM-‐124E Colitis
Collaboration
Univ. of
Zurich;
Pre-‐
clinical
acute
studies
positive
(04/17)
IMM-‐124E Autism
Childrens Research
Institute,
La
Trobe
&
RMIT
Universities
Anti-‐Infective
Programs
IMM-‐529 C.
difficile Phase
1/2
Expected
to
start
2Q
2017
IMM-‐124E
/
Shigella
Vaccine
Shigella
Infections
Collaboration
with
US
Army
IMM-‐124E
Campylobacter;
ETEC
Infections
Collaboration
with
US
Navy
9. NASH (Non-Alcoholic Fatty Liver)
Pathophysiology
9
NASH – Pathophysiology
• Blood derived antigens
(including circulating
LPS) determines
tolerance vs.
inflammation
• Kupffer cells play a key
role in liver inflammation
and fibrosis
• Tregs hold a key role in
tolerance (homeostasis)
• Much like hepatic
tolerance the gut
immune system can
promote anti-
inflammatory effect
Source: Adapted from Cohen-Naftaly; Scott L. Friedman, 2011
10. IMM-124E in NASH (Non-Alcoholic Fatty Liver)
10
• Broad anti-inflammatory mechanism of action
- Targeted LPS antibodies
- Upstream Effect: LPS-TLR4 pathway
- Downstream: Anti-inflammatory through both innate and adaptive immune
systems (e.g., the induction of regulatory T-cells to control and inhibit excess
inflammation)
• Strong anti-fibrotic effect demonstrated with CCl4 model
• Unique competitive profile due to safety/MOA:
- Addresses multi-factorial nature of NASH
- Potential for broad combination use
- Safety profile supporting of long-term chronic use
- Potential to expand to mild/moderate populations
• Market exclusivity (biologics; High barriers to generic biosimilar entry)
11. Cirrhosis
1.2M people
F4
IMM-124E – Uniquely Positioned to Address
Large Unmet Need of $35B Market (2030)
11
NAFLD
Up to 145M People
• No regulatory
pathway currently
exists for NAFLD
• Drug would need to
be extremely safe to
be considered for
trial / approval
• NAFLD not
available to current
competitors due to
safety profile
• Up to 50% of the
US population are
thought to have
NAFLD
NASH
25M People
F0 F1 F2 F3
17M People 8M People
Intercept (OCA)
Tobira (CCR2/CCR5)
Galmed (Aramchol)
Genfit (Elafibranor)
Galectin (GR-MD-02)
• Only asset in development that, due to its safety profile:
- Can potentially targetall spectrum of the disease including mild/moderate patients
- Likely can be used in combination with any other agents currently in development
- No safety concerns to date that could limit chronic / long-term use
IMM-124E
12. IMM-124E: Fatty-Liver Portfolio – 3 Phase II
Trials
12
Three Ongoing Phase 2 Programs: NASH, ASH and Pediatric NAFLD
NASH
• Lead Principal Investigator:Arun Sanyal;Former PresidentofAASLD (American Association for the Study
of Liver Diseases) and currentChair of the Liver Study Section at the NIH (National Institute of Health)
• Multi-center, double-blinded,placebo controlled trial;25 sites running in US, Australia and Israel
• Fully recruited:134 patients with biopsy proven NASH
• Primary endpoint:changes in liver fat content confirmed by MRI; changes in ALT(liver enzymes)
• 3 arms: placebo,high dose and low dose
• Timing:topline results by 4Q 2017
ASH
• NIH funded;sponsored by University of Virginia
• Expected enrollment:66 patients
• Endpoint:ALT
• Timing:topline results in 2018
Pediatric
NAFLD
• NIH funded;sponsored by Emory University
• Expected enrollment:40 patients
• Endpoint:ALT; 3 months treatment
• Timing:topline results in 1H 2018
13. IMM-124E – Summary of Data
Prevention of Fibrosis and Improvement in Metabolic & Inflammatory Markers
13
CCl4 Fibrosis
Studies
• Carbon-Tetrachloride (CCl4) a non-disease related fibrosis model
• Aim: To demonstrate effects of IMM-124E on Fibrosis caused by Intraperitoneal CCl4
• Results:
- Marked reduction in Liver Fibrosis and Inflammation on Histology
- Marked reduction on Liver Damage markers (i.e.ALT, Bilirubin etc.)
- Marked reduction in Liver ActivatedMacrophages (F4/80 high)
Ob-Ob Mice
• Model represents the Metabolic syndrome
• Aim: To demonstrate the effect of IMM-124E or anti-LPS IgG (derived from IMM-124E)
• Results:
- Anti-LPS IgG considerable reduces ALTlevel
- Improved metabolic status for IG and IMM-124E treated mice (i.e. TG, Fasting
Glucose and OGTT)
- Anti-inflammatory shift: DecreasedTNF-α and increase splenic NKT cells
Phase 1/2
Clinical Studies
• Aim: To show safety and efficacy of IMM-124E Biopsy Proven NASH Patients
• Population: 10 subjects with biopsy proven NASH and Type 2 Diabetes
• Results:
- Improved Metabolic status (e.g. HbA1c,HOMA OGTT) GLP1 and Adiponectin
- Improved Liver status (e.g. ALT)
- Proof of concept: increase in Circulatory Regulatory T-Cell
15. Animal Models: IMM-124E Improves Fibrosis
and Inflammatory Markers
15
Group A:
Control
Group D:
Treated
Group B: Naïve
anti LPS
Group C:
Treated
2.4
0.66
1.4 1.33
0
0.5
1
1.5
2
2.5
3
A B C D
*p<0.02
^^ p<0.01
Group A:
Control
Group D:
Treated
Group B: Naïve
anti LPS
Group C:
Treated
0
1
1.8
3.4
0
0.5
1
1.5
2
2.5
3
3.5
4
A B C D
*p<0.0009
^^ p<0.0003
Decrease Portal Inflammation Improved Metavir Fibrosis Score
Mizrahi M. 2013, AASLD; Hepatology 751A
17. Suppression of F4/80High Macrophages
17
Marked Reduction in LiverActivated Macrophages (F4/80 high)
18. Phase 1/2: Improves Liver Function and
Reduces Insulin Resistance
18
Results of a Phase 1/2a clinical trial; N=10
30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED
Improved Liver EnzymesImproved HBA1C, OGTT and HOMA
Mizrahi M, J Inflamm Res. 2012;5:141-50
Improved Metabolic Status (e.g. HbA1c,
HOMA OGTT) GLP1, and Adiponectin
and Liver Function (e.g.ALT)
19. Phase 1/2: Improves Inflammatory Biomarkers
19
Increased CD4+CD25+FOXP3+ TREGS
Day 1 Day 30
Mizrahi M. J Inflamm Res. 2012
Increased GLP1 and Adiponectin
Proof of Concept:
Increase in Circulatory
Regulatory T-Cell
22. IMM-529 in Clostridium difficile Infection (CDI)
22
• Biologic with unique triple mechanism of action
- Antibodies neutralize the toxin B, the spores and the vegetative cells
• Potential to redefine the standard-of-care (SOC) therapy for CDI
- Current antibiotic treatments exacerbate recurrence
- IMM-529 stops virulence, without impacting the microbiome
- Compelling data in all three phases of the disease including (1) prevention of primary
disease, (2) treatment of primary disease and (3) prevention of recurrence
- Orally administrated, safe
• >70% survival rate in CDI mice treated with IMM-529 vs. <7% survival rate
in control groups
• Potential orphan disease designation; Potential breakthrough / fast track
designations
• Market exclusivity (biologics; High barriers to generic biosimilar entry)
23. IMM-529 for the Treatment of CDI
23
Market
Opportunity
• Therapeutic market is expected to grow from US$356.3 million in 2014 to over $1.5
billion by 2024 – CAGR 15%
• Nearly 30,000 patients die each year from C. difficile infections (US)
• Potential orphan disease (7 years market exclusivity and premium pricing)
Unmet Need
• Vancomycin and metronidazole are the currentstandard of care, accounting for 80% of
patientshare (US)
• However,therapies are plagued by significantCDI recurrences (1strelapse:25%; 2nd:
40%; 3rd: 50%) underscoring need for new treatments
• There is also growing resistance to vancomycin treatment
IMM-529
Positioning
• Highly differentiated – Neutralizes C.difficile but does not impact microbiome
• Only asset that targets not only toxin B but also the spores and the vegetative cells
responsible for recurrence
• Can be used in combination with standard ofcare
• Targets many isolates
Sources: GlobalData, Decision Resources, CDC
24. Triple Action MOA
Neutralizing C. difficile; Sparing the Microbiome
24
Spores – Infectious Particles
IMM-529 antibodies bind to
multiple epitopes on surface
antigens on spores and
prevent adheres to host cells
and limit germination.
Heat, ethanol and UV
resistant. Survive gastric acid,
adhere to cells in the colon
and germinate.
Vegetative Cells
IMM-529 antibodies bind to
multiple epitopes on the
surface layer proteins (SLP)
on vegetative cells and limit
colonization.
Fimbriae and other surface
layer proteins (SLP) contribute
to bacterialcolonization.
Fimbriae are used to adhere to
other bacteria and to host cells
and is one of the primary
mechanisms of virulence
Toxin B
IMM-529 antibodies bind to
multiple epitopes effectively
neutralize toxin B, inhibiting toxin
mediated epithelial cell apoptosis
and limit toxin translocation into
the systemiccirculation and
inflammatory cascades.
Toxin B is essentialfor
virulence. Toxin B disrupt the
cytoskeleton and tight
junctions of intestinal epithelial
cells.
3
1
2
25. Results of Pre-Clinical Studies
25
0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0
0
2 0
4 0
6 0
8 0
1 0 0
S u rv iv a l
h o u rs p o s t in fe c tio n
Percentsurvival
U n in fe c te d , N o tre a tm e n t
In fe c te d , N o tre a tm e n t
In fe c te d , N o n -im m u n e Ig G tre a tm e n t
In fe c te d , IM M -5 2 9 tre a tm e n t
In fe c te d , V a n c o m y c in tre a tm e n t
PreventionStudies
Demonstrated ~70%
survival rate without
use of antibiotics vs.
0% for control group
(P<0.0001)
All studies
statistically
significant
TreatmentStudies
Demonstrated ~80%
survival rate without
use of antibiotics vs.
<7% in control group
(P<0.0001)
0 1 2 3 4
0
2 0
4 0
6 0
8 0
1 0 0
D a y s p o s t in fe c tio n
Percentsurvival
S u rv iv a l
In fe c te d , N o tre a tm e n t
In fe c te d , N o n -im m u n e Ig G tre a tm e n t
In fe c te d , IM M -5 2 9 tre a tm e n t
In fec te d , V a n c o m y c in trea tm e n t
U n in fe c te d , N o tre a tm e n t
RelapseStudies
Demonstrated ~80%
survival rate vs.
~11% survival rate
in control group
(P<0.0027)
Potentially only
therapeutic
(approved or in
development) that
can treat all
phases of the
disease:
1. Prophylaxis
2. Treatment
3. Recurrence
0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0
0
1 0
2 0
3 0
4 0
5 0
6 0
7 0
8 0
9 0
1 0 0
1 1 0
S u rv iv a l
D a y s a fte r v a n c o m y c in tre a tm e n t c e a s e d
Percentsurvival
In fe c te d + S O C
In fe c te d + S O C + IM M -5 2 9**
p=0.0027
26. Phase 1/2 Study Design
26
• Phase 1/2, randomized, double blind, placebo-controlled clinical study of IMM-529
for the treatment of CDI
• 60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20
subjects to be enrolled within the first 72 hours)
• Subjects randomized to IMM-529 or placebo in a 2:1 ratio
• Treatment duration: 28 days on top of SOC (vancomycin / metronidazole)
• Follow-up: 3 months
• Primary objective: To evaluate the safety and tolerability of IMM-529 together with
standard of care (SOC) in patients with CDI
• Secondary objective: To evaluate the effectiveness of IMM-529 together with SOC to
treat patients with CDI
Phase 1/2 Study in CDI Expected to Commence 2Q 2017
27. • Clinical supplies manufacturing
• Initiation of Phase 1/2 Trial in CDI
• Topline results expected from
Phase 1/2 study in CDI
IMM-529 Key Milestones
27
2Q
2017
2018
29. Robust IP and Extended Market Protection
29
Strong Patent
Portfolio
• 6 patent families offering composition and/or method of treatment claims
• Approved / pending in major geographies including US, Europe, Japan and
China
• Granted patent terms ending between 2024 and 2030 with possible
extensions
Extended
Market
Exclusivity
• Immuron’s drugs are considered “biologics” by the FDA
• In the US, this is expected to confer Immuron’s new drugs 12 years of
market exclusivity, offering investors a long revenue tail
Generic
Protection
• Immuron’s drug not absorbed in the blood
• No baseline for PK studies
• This results in lengthy process for biosimilar manufacturers
30. • 2016:
Licensed
preclinical
NASH
asset
• ~$50M
upfront
+
other
undisclosed
milestones
Recent High-Value NASH LM&A Highlights
Potential for Significant Upside
30
• Focused on advancing IMM-124E and IMM-529 through key clinical inflection points while
pursuing partnering opportunities
• Recent licensing and M&A partnerships in NASH underscores potential of IMM-124E
• 2016:
Acquired
Tobira
• ~$530M
(5x
market
cap
at
time
of
announcement),
in
a
deal
valued
at
up
to
$1.7B
• 2015:
Acquired
Phenex
• NASH
asset
in
Phase
2
• Total
deal
value
$470M
• 2014:
Acquired
Nimbus
• Preclinical
assets
and
platform
• $400M upfront
in
a
deal
valued
at
$1.2B
• 2015:
Acquired
Pharmaxis
• NASH
asset
in
Phase
1
• $39M
upfront
– Total
deal
value
$600M
• 2014:
Acquired
Lumena
• 2
Phase
2
assets
for
NASH
and
cholestatic
liver
disease
• Total
deal
value
$260M
31. NASH and C. difficile Comps Indicate
Potential for Substantial Growth
31
Company Ticker Program Development
Stage Market
Cap*
Program
in
NASH
ICPT Obeticholic
acid Phase
3 US$2.9B
GNFT Elafibranor Phase
3 US$1.1B
CNAT ENCORE-‐LF
Phase
2 US$195M
Program
in
C.
Difficile
MCRB SER-‐109;
SER-‐262 Phase
2 US$423M
SMMT SMT19969 Phase
1 US$143M
ASMB ABI-‐M101 Preclinical US$419M
*As of May 4, 2017
32. 32
Company Capitalization
Immuron Limited Ordinary Shares ADSs
Shares 103,641,417 610,000
Options1 33,177,523 N/A
Warrants2
N/A 610,000
Total
136,818,940 1,220,000
1. Options
-‐ Weighted
average
exercise
price:
AUD$0.544
2. ADS
-‐ 100%
of
listing
price
($10)
33. Travelan OTC/Business
A unique Preventative Treatment for Traveler’s Diarrhea
• Travelan/OTC: Unique value proposition that is valued by consumers and customers
- Up to 90% effective in preventing Traveler’s Diarrhea
- Significantly reduces the motility of ETEC strains
- Binds to multiple epitopes and antigens on both the bacterial surface and flagella
- Has substantially greater reactivity against purified ETEC flagella antigen than IgG purified from non-
immune colostrum powder
• Multiple ways to keep growing OTC business:
- Continued penetration of current markets
- Geographic expansions
- New products / New formulations (e.g., shigella)
• Annual Revenues of AU$1M+; Cash flow positive
- Net revenues: 1H2017 +41% vs 1H2016
- Pursuing new geographies
- Potential WW peak sales: $20M+
- Global Traveler’s Diarrhea market estimated at $600M
33
34. Key Milestones Through 2018
34
• IMM-529
- Clinical supplies
manufacturing
- Initiation of Phase
1/2 Trial in CDI
• Uplist to NASDAQ
• IMM-124E
- NASH Phase 2
interim analyses
- SanyalBio – NASH
MOA
• IMM-124E
- NASH Phase 2
topline results
- Duke – NASH MOA
• IMM-124E
- NASH centric transaction
- Pediatric NAFLD Phase 2
topline results
- ASH Phase 2 topline
results
• IMM-529
- Topline results expected
from Phase 1/2 study in
CDI
2Q
2017
3Q
2017
4Q
2017
2018
Results from colitis preclinical studies and Army
and US Navy trials expected2017/2018
35. Investment Highlights
35
ü Targeting
inflammatory-‐mediated
and
infectious
diseases
with
novel
oral
immunotherapies
ü Lead
program,
IMM-‐124E,
in
Phase
2
with
key
data
readouts
before
year
end
ü Phase
1/2
study
IMM-‐529
for
treatment
of
CDI
expected
to
commence
2Q
2017
ü Well
positioned
to
address
high
unmet
medical
need
in
multiple
blockbuster
markets
ü High-‐value
peer
licensing
deals
and
M&A
underscore
potential
upside
ü Company
uplisted to
NASDAQ
in
June
2017
(NASDAQ:
IMRN)
ü Experienced
Management
Team
with
strong
support
from
leading
KOLs
and
institutions