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.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
Senesco Technologies is developing a novel cancer therapy targeting B-cell cancers like multiple myeloma. Their gene regulation platform technology uses nanoparticles to eliminate cancer cells by turning on cell death pathways and turning off cell growth signals. Preclinical studies show efficacy against blood cancers. A Phase 1b/2a clinical trial in relapsed/refractory multiple myeloma and lymphomas is ongoing, with initial results showing stable disease in some patients. Senesco aims to develop their technology into a breakthrough treatment for hematologic cancers with a large market potential.
This presentation provides an overview of Pressure BioSciences, Inc. Key points include:
- PBI develops instruments and consumables for pressure cycling technology (PCT) sample preparation. PCT uses repeated high-pressure cycles to control molecular interactions.
- PBI's primary market is the biopharma industry, where PCT systems are used from biomarker discovery through validation and quality control. Over 270 PCT systems have been installed.
- A new next-generation PCT instrument, the Barocycler 2320EXTREME, was recently released.
- PBI is also developing ultra-shear technology to produce nanoemulsions for applications in food, pharmaceuticals, and other
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
Analysis of Emerging Cancer Diagnostic Tests and Strategic Profile of Leading...ReportsnReports
This 286-page report provides a comprehensive analysis and profile of emerging cancer diagnostic tests and leading suppliers in the industry. It examines major categories of circulating and cellular diagnostic tests, including biochemical markers, oncogenes, growth factors, hormones, colony stimulating factors, lymphokines, and immunohistochemical stains. The report also provides profiles of major companies developing or marketing these diagnostic tests and evaluates the diagnostic prospects and medical rationale for emerging cancer diagnostic technologies.
This investor presentation summarizes the development of Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus. Key points include:
1) REOLYSIN has demonstrated statistically significant improvements in overall survival for metastatic breast cancer and doubled two-year survival for metastatic pancreatic cancer.
2) The clinical development plan focuses on combination therapies with chemotherapy, immunotherapy agents like pembrolizumab, and targeted therapies/IMiDs to boost REOLYSIN's mechanism of action.
3) Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile with no maximum tolerated dose reached and mostly mild side effects.
ROSALIND is a computer simulation program that uses a patient's tumor gene profile to evaluate all available cancer therapy options and predict the most effective treatments. It can simulate over 10,000 drug combinations in under 2 hours, allowing for a comprehensive and fast analysis. ROSALIND's predictions aim to personalize cancer treatment for each patient and help guide them to therapies with the highest chance of remission or available clinical trials when standard options are unlikely to work. The company envisions ROSALIND being widely adopted to achieve higher remission rates and lower healthcare costs through more personalized cancer care.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
Senesco Technologies is developing a novel cancer therapy targeting B-cell cancers like multiple myeloma. Their gene regulation platform technology uses nanoparticles to eliminate cancer cells by turning on cell death pathways and turning off cell growth signals. Preclinical studies show efficacy against blood cancers. A Phase 1b/2a clinical trial in relapsed/refractory multiple myeloma and lymphomas is ongoing, with initial results showing stable disease in some patients. Senesco aims to develop their technology into a breakthrough treatment for hematologic cancers with a large market potential.
This presentation provides an overview of Pressure BioSciences, Inc. Key points include:
- PBI develops instruments and consumables for pressure cycling technology (PCT) sample preparation. PCT uses repeated high-pressure cycles to control molecular interactions.
- PBI's primary market is the biopharma industry, where PCT systems are used from biomarker discovery through validation and quality control. Over 270 PCT systems have been installed.
- A new next-generation PCT instrument, the Barocycler 2320EXTREME, was recently released.
- PBI is also developing ultra-shear technology to produce nanoemulsions for applications in food, pharmaceuticals, and other
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
Analysis of Emerging Cancer Diagnostic Tests and Strategic Profile of Leading...ReportsnReports
This 286-page report provides a comprehensive analysis and profile of emerging cancer diagnostic tests and leading suppliers in the industry. It examines major categories of circulating and cellular diagnostic tests, including biochemical markers, oncogenes, growth factors, hormones, colony stimulating factors, lymphokines, and immunohistochemical stains. The report also provides profiles of major companies developing or marketing these diagnostic tests and evaluates the diagnostic prospects and medical rationale for emerging cancer diagnostic technologies.
This investor presentation summarizes the development of Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus. Key points include:
1) REOLYSIN has demonstrated statistically significant improvements in overall survival for metastatic breast cancer and doubled two-year survival for metastatic pancreatic cancer.
2) The clinical development plan focuses on combination therapies with chemotherapy, immunotherapy agents like pembrolizumab, and targeted therapies/IMiDs to boost REOLYSIN's mechanism of action.
3) Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile with no maximum tolerated dose reached and mostly mild side effects.
ROSALIND is a computer simulation program that uses a patient's tumor gene profile to evaluate all available cancer therapy options and predict the most effective treatments. It can simulate over 10,000 drug combinations in under 2 hours, allowing for a comprehensive and fast analysis. ROSALIND's predictions aim to personalize cancer treatment for each patient and help guide them to therapies with the highest chance of remission or available clinical trials when standard options are unlikely to work. The company envisions ROSALIND being widely adopted to achieve higher remission rates and lower healthcare costs through more personalized cancer care.
Senesco Technologies is developing a gene regulation technology to treat cancer. They are running a Phase 1b/2a clinical trial of their lead product, SNS01-T, to treat B-cell cancers like multiple myeloma and lymphoma. Preclinical studies show SNS01-T significantly inhibits tumor growth and improves survival in mouse models of these cancers. The presentation provides an overview of Senesco's technology, clinical trial status, financial information, and development plans to advance SNS01-T and expand to additional cancer indications.
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
COTI-2 is a small molecule discovered by Critical Outcome Technologies to reactivate mutant p53 through zinc chelation. It demonstrates strong efficacy against a wide range of p53 mutations in vitro and significant tumor growth inhibition in vivo without inducing resistance. Further studies confirmed COTI-2's p53-dependent mechanism of action and ability to modulate the PI3K/AKT pathway. An IND filing is planned in mid-2014 to study COTI-2 in gynecological cancers.
This presentation summarizes an oncology focused immunotherapy company. Key points include:
- The company has a pioneering immunotherapy technology that induces, activates and causes proliferation of cytotoxic T-cells to target cancer.
- Clinical development is focused on secondary prevention in cancer survivors to redefine the standard of care with targeted therapies to prevent cancer recurrence.
- The company has two lead programs - NeuVax targeting HER2 positive breast and gastric cancers, and GALE-301/302 targeting folate binding protein in ovarian and endometrial cancers.
- NeuVax is in a Phase 3 clinical trial (PRESENT) in breast cancer and other trials are ongoing or planned in breast and gastric cancers. GALE-
The document provides an overview of Targovax's clinical programs for ONCOS-102 and TG01. For ONCOS-102, a Phase I/II trial in ovarian and colorectal cancer in combination with durvalumab was initiated in Q3 2017. Encouraging survival and immune response data was reported from the ongoing Phase I/II trial of TG01 in resected pancreatic cancer. Targovax is developing these programs to boost the effectiveness of immunotherapy and has clinical readouts expected in 2017-2019.
Breakthrough Nanoparticle Drug Delivery Platform Enabling Lead Compound nanoFenretinide (ST-001): SciTech Development presentation with a focus on pediatric oncology (cancer) including Ewing’s Sarcoma Family of Tumours (ESFT), leukemia - acute lymphocytic leukemia (ALL), acute myelogenous leukemia (AML); and, neuroblastoma. The pitch deck also includes a company overview, proprietary technology, lead drug ST-001 nanoparticle fenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, other cancer indications, investment opportunity and drug mechanism of action (MOA).
Targovax is developing two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide vaccine targeting RAS mutations. Early phase clinical trial data shows promise for both platforms. ONCOS-102 increased tumor-infiltrating CD8+ T-cells in 11 of 12 cancer patients and induced systemic anti-tumor immune responses. TG01 shows a median survival of 33.1 months in a phase I/II pancreatic cancer trial compared to historical controls of 27.6 months. Targovax has initiated six new clinical trials to further evaluate these platforms alone and in combination with other therapies.
This document provides an overview of Targovax, a biotechnology company developing immunotherapy treatments for cancer. It summarizes Targovax's two platform technologies: ONCOS-102, an oncolytic virus that selectively infects and lyses cancer cells to trigger an immune response, and TG neoantigen vaccines that target specific cancer mutations to generate T-cells to kill cancer cells. The document outlines Targovax's clinical development plans and timelines across six clinical trials in several cancer indications. It also reviews the company's financial position and shareholder base, noting a strong cash runway into 2019 to complete the planned clinical program.
1706 ir deck full w_appendix v1_cmd_v12_netttargovax2017
The document discusses Targovax's TG01 peptide vaccine platform. TG01 primes the immune system to recognize and destroy cancer cells with RAS mutations through a cocktail of 7 peptides covering common RAS mutations. Earlier trials in pancreatic cancer showed encouraging median and 1-year survival rates compared to historical controls when TG01 was administered with GM-CSF adjuvant. Long-term survival data also correlated with immune responses detected following vaccination.
Metastatic breast cancer remains a major unmet medical need, with over 1.7 million new cases diagnosed globally in 2012. Several new therapeutic targets and agents are in development to treat metastatic breast cancer and its subtypes. These include agents targeting intra-tumoral drivers like HER2, IGF, HGF, PI3K/AKT/mTOR, PARP, and AR. Agents also target the tumor microenvironment, such as anti-angiogenics targeting VEGF and agents targeting immune cells. Many of these novel agents are currently in Phase II or III clinical trials alone or in combination with standard therapies. Developing strategies to optimize targeted treatments and combinations holds promise to improve outcomes for patients with advanced breast cancer.
Targovax is developing immunotherapies to enable the immune system to kill cancer cells. They have two platforms: oncolytic viruses and peptide vaccines. Their peptide vaccine TG01 showed encouraging 2-year survival data in a Phase I/II trial in pancreatic cancer patients, with a survival rate higher than historical controls. Their oncolytic virus ONCOS-102 is in a Phase I trial in CPI-refractory melanoma patients to see if it can activate the immune system and make those patients responsive to checkpoint inhibitors again. Targovax has multiple clinical readouts expected in 2017 and 2018 that could be value inflection points.
An oncology-focused immunotherapy company is conducting a Phase 3 clinical trial of its lead product, NeuVax, for the prevention of breast cancer recurrence in early-stage, node-positive patients. The trial is fully enrolled with 758 participants and is evaluating NeuVax compared to placebo on disease-free survival. NeuVax targets the HER2 protein and consists of an HLA-A2/A3-restricted peptide that elicits CD8+ T-cell responses. Previous clinical trials demonstrated NeuVax has a positive safety profile and signals of efficacy in reducing recurrence rates. An interim analysis is upcoming in mid-2016, with final results expected in 2018.
Targovax presented its 3Q 2017 results, highlighting ongoing clinical trials with its two platforms: ONCOS-102, an oncolytic virus in Phase I/II trials in combination with other therapies, and TG01, a neoantigen vaccine showing encouraging survival data in a Phase I/II trial in pancreatic cancer. Targovax has a cash runway into 2019 to fund its clinical programs and is listed on the Oslo Stock Exchange with a market capitalization of around NOK 930 million.
Targovax presented highlights from Q1 2017, including encouraging survival data from a phase I/II trial of TG01 in pancreatic cancer. 68% of patients were still alive after 2 years, compared to historical rates of 30-53%. Targovax will present further clinical data on TG01 at ASCO in June. The company initiated an exploratory trial of TG01 in colorectal cancer and has six clinical trials ongoing or planned in 2017-2018 across cancer indications. Financially, Targovax has cash of NOK 147M and an operating expenses run rate of NOK 104M annually based on the last four quarters.
1706 ir deck full w_appendix v1_cmd_v6_uten appendixtargovax2017
The document summarizes a capital markets update presentation by Targovax. It discusses Targovax's two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide cancer vaccine. For ONCOS-102, the virus is injected into tumors where it stimulates an immune response by releasing cancer antigens. TG01 mimics antigens to stimulate "killer" T-cells. Early clinical trial results for ONCOS-102 showed increased tumor-infiltrating T-cells and systemic immune responses in cancer patients. Targovax is pursuing multiple clinical trials to combine its immunotherapies with other treatments.
This document provides an overview of Targovax, a biotech company developing immunotherapies for cancer. It summarizes their two platforms: ONCOS-102, an oncolytic virus, and TG, a neoantigen cancer vaccine targeting RAS mutations. For ONCOS-102, phase 1 data showed it can activate the immune system against tumors. Targovax is conducting multiple clinical trials of ONCOS-102 in combination with other therapies. For TG, earlier phase 1 trials showed a 20% 10-year survival rate in pancreatic cancer patients. A recent phase 1/2 trial in pancreatic cancer showed encouraging survival and safety data. Targovax is seeking a partner to advance TG into a
Targovax is developing two cancer immunotherapy drugs - ONCOS-102, an oncolytic virus, and TG01, a neoantigen vaccine. Data from clinical trials of ONCOS-102 showed it activated patients' immune systems against their tumors. Targovax has an ongoing clinical program testing ONCOS-102 in various cancer types and combinations. TG01 targets RAS mutations in pancreatic cancer and showed encouraging long-term survival rates in previous trials. A recent trial combining TG01 with chemotherapy showed improved median and 2-year survival over historical controls. Targovax is seeking a partner to advance TG01 into a late-stage trial aimed at registration.
Arming the patient's immune system to fight cancertargovax2017
This document summarizes a presentation by Targovax CEO Øystein Soug at a healthcare conference on December 15, 2016. Targovax is developing immunotherapies to enable the immune system to kill cancer cells, including oncolytic viruses, peptide vaccines, cell therapies, and checkpoint inhibitors. The presentation outlines Targovax's clinical trial pipeline and strategy, including trials of ONCOS-102 in CPI-refractory melanoma and mesothelioma and TG01 in resected pancreatic and colorectal cancers. Near-term value drivers include TG01 two-year survival data in pancreatic cancer in 1H2017 and ONCOS-102 interim data in melanoma in 2H2017.
Targovax is developing immunotherapies to help the immune system fight cancer. They have six ongoing clinical trials combining their oncolytic adenovirus or peptide vaccines with checkpoint inhibitors or chemotherapy. They expect readouts from four of these trials in 2017-2018, which will be important value inflection points. Encouraging survival data was seen in a Phase I/II trial of their peptide vaccine TG01 in resected pancreatic cancer patients.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
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 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.
Senesco Technologies is developing a gene regulation technology to treat cancer. They are running a Phase 1b/2a clinical trial of their lead product, SNS01-T, to treat B-cell cancers like multiple myeloma and lymphoma. Preclinical studies show SNS01-T significantly inhibits tumor growth and improves survival in mouse models of these cancers. The presentation provides an overview of Senesco's technology, clinical trial status, financial information, and development plans to advance SNS01-T and expand to additional cancer indications.
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
COTI-2 is a small molecule discovered by Critical Outcome Technologies to reactivate mutant p53 through zinc chelation. It demonstrates strong efficacy against a wide range of p53 mutations in vitro and significant tumor growth inhibition in vivo without inducing resistance. Further studies confirmed COTI-2's p53-dependent mechanism of action and ability to modulate the PI3K/AKT pathway. An IND filing is planned in mid-2014 to study COTI-2 in gynecological cancers.
This presentation summarizes an oncology focused immunotherapy company. Key points include:
- The company has a pioneering immunotherapy technology that induces, activates and causes proliferation of cytotoxic T-cells to target cancer.
- Clinical development is focused on secondary prevention in cancer survivors to redefine the standard of care with targeted therapies to prevent cancer recurrence.
- The company has two lead programs - NeuVax targeting HER2 positive breast and gastric cancers, and GALE-301/302 targeting folate binding protein in ovarian and endometrial cancers.
- NeuVax is in a Phase 3 clinical trial (PRESENT) in breast cancer and other trials are ongoing or planned in breast and gastric cancers. GALE-
The document provides an overview of Targovax's clinical programs for ONCOS-102 and TG01. For ONCOS-102, a Phase I/II trial in ovarian and colorectal cancer in combination with durvalumab was initiated in Q3 2017. Encouraging survival and immune response data was reported from the ongoing Phase I/II trial of TG01 in resected pancreatic cancer. Targovax is developing these programs to boost the effectiveness of immunotherapy and has clinical readouts expected in 2017-2019.
Breakthrough Nanoparticle Drug Delivery Platform Enabling Lead Compound nanoFenretinide (ST-001): SciTech Development presentation with a focus on pediatric oncology (cancer) including Ewing’s Sarcoma Family of Tumours (ESFT), leukemia - acute lymphocytic leukemia (ALL), acute myelogenous leukemia (AML); and, neuroblastoma. The pitch deck also includes a company overview, proprietary technology, lead drug ST-001 nanoparticle fenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, other cancer indications, investment opportunity and drug mechanism of action (MOA).
Targovax is developing two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide vaccine targeting RAS mutations. Early phase clinical trial data shows promise for both platforms. ONCOS-102 increased tumor-infiltrating CD8+ T-cells in 11 of 12 cancer patients and induced systemic anti-tumor immune responses. TG01 shows a median survival of 33.1 months in a phase I/II pancreatic cancer trial compared to historical controls of 27.6 months. Targovax has initiated six new clinical trials to further evaluate these platforms alone and in combination with other therapies.
This document provides an overview of Targovax, a biotechnology company developing immunotherapy treatments for cancer. It summarizes Targovax's two platform technologies: ONCOS-102, an oncolytic virus that selectively infects and lyses cancer cells to trigger an immune response, and TG neoantigen vaccines that target specific cancer mutations to generate T-cells to kill cancer cells. The document outlines Targovax's clinical development plans and timelines across six clinical trials in several cancer indications. It also reviews the company's financial position and shareholder base, noting a strong cash runway into 2019 to complete the planned clinical program.
1706 ir deck full w_appendix v1_cmd_v12_netttargovax2017
The document discusses Targovax's TG01 peptide vaccine platform. TG01 primes the immune system to recognize and destroy cancer cells with RAS mutations through a cocktail of 7 peptides covering common RAS mutations. Earlier trials in pancreatic cancer showed encouraging median and 1-year survival rates compared to historical controls when TG01 was administered with GM-CSF adjuvant. Long-term survival data also correlated with immune responses detected following vaccination.
Metastatic breast cancer remains a major unmet medical need, with over 1.7 million new cases diagnosed globally in 2012. Several new therapeutic targets and agents are in development to treat metastatic breast cancer and its subtypes. These include agents targeting intra-tumoral drivers like HER2, IGF, HGF, PI3K/AKT/mTOR, PARP, and AR. Agents also target the tumor microenvironment, such as anti-angiogenics targeting VEGF and agents targeting immune cells. Many of these novel agents are currently in Phase II or III clinical trials alone or in combination with standard therapies. Developing strategies to optimize targeted treatments and combinations holds promise to improve outcomes for patients with advanced breast cancer.
Targovax is developing immunotherapies to enable the immune system to kill cancer cells. They have two platforms: oncolytic viruses and peptide vaccines. Their peptide vaccine TG01 showed encouraging 2-year survival data in a Phase I/II trial in pancreatic cancer patients, with a survival rate higher than historical controls. Their oncolytic virus ONCOS-102 is in a Phase I trial in CPI-refractory melanoma patients to see if it can activate the immune system and make those patients responsive to checkpoint inhibitors again. Targovax has multiple clinical readouts expected in 2017 and 2018 that could be value inflection points.
An oncology-focused immunotherapy company is conducting a Phase 3 clinical trial of its lead product, NeuVax, for the prevention of breast cancer recurrence in early-stage, node-positive patients. The trial is fully enrolled with 758 participants and is evaluating NeuVax compared to placebo on disease-free survival. NeuVax targets the HER2 protein and consists of an HLA-A2/A3-restricted peptide that elicits CD8+ T-cell responses. Previous clinical trials demonstrated NeuVax has a positive safety profile and signals of efficacy in reducing recurrence rates. An interim analysis is upcoming in mid-2016, with final results expected in 2018.
Targovax presented its 3Q 2017 results, highlighting ongoing clinical trials with its two platforms: ONCOS-102, an oncolytic virus in Phase I/II trials in combination with other therapies, and TG01, a neoantigen vaccine showing encouraging survival data in a Phase I/II trial in pancreatic cancer. Targovax has a cash runway into 2019 to fund its clinical programs and is listed on the Oslo Stock Exchange with a market capitalization of around NOK 930 million.
Targovax presented highlights from Q1 2017, including encouraging survival data from a phase I/II trial of TG01 in pancreatic cancer. 68% of patients were still alive after 2 years, compared to historical rates of 30-53%. Targovax will present further clinical data on TG01 at ASCO in June. The company initiated an exploratory trial of TG01 in colorectal cancer and has six clinical trials ongoing or planned in 2017-2018 across cancer indications. Financially, Targovax has cash of NOK 147M and an operating expenses run rate of NOK 104M annually based on the last four quarters.
1706 ir deck full w_appendix v1_cmd_v6_uten appendixtargovax2017
The document summarizes a capital markets update presentation by Targovax. It discusses Targovax's two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide cancer vaccine. For ONCOS-102, the virus is injected into tumors where it stimulates an immune response by releasing cancer antigens. TG01 mimics antigens to stimulate "killer" T-cells. Early clinical trial results for ONCOS-102 showed increased tumor-infiltrating T-cells and systemic immune responses in cancer patients. Targovax is pursuing multiple clinical trials to combine its immunotherapies with other treatments.
This document provides an overview of Targovax, a biotech company developing immunotherapies for cancer. It summarizes their two platforms: ONCOS-102, an oncolytic virus, and TG, a neoantigen cancer vaccine targeting RAS mutations. For ONCOS-102, phase 1 data showed it can activate the immune system against tumors. Targovax is conducting multiple clinical trials of ONCOS-102 in combination with other therapies. For TG, earlier phase 1 trials showed a 20% 10-year survival rate in pancreatic cancer patients. A recent phase 1/2 trial in pancreatic cancer showed encouraging survival and safety data. Targovax is seeking a partner to advance TG into a
Targovax is developing two cancer immunotherapy drugs - ONCOS-102, an oncolytic virus, and TG01, a neoantigen vaccine. Data from clinical trials of ONCOS-102 showed it activated patients' immune systems against their tumors. Targovax has an ongoing clinical program testing ONCOS-102 in various cancer types and combinations. TG01 targets RAS mutations in pancreatic cancer and showed encouraging long-term survival rates in previous trials. A recent trial combining TG01 with chemotherapy showed improved median and 2-year survival over historical controls. Targovax is seeking a partner to advance TG01 into a late-stage trial aimed at registration.
Arming the patient's immune system to fight cancertargovax2017
This document summarizes a presentation by Targovax CEO Øystein Soug at a healthcare conference on December 15, 2016. Targovax is developing immunotherapies to enable the immune system to kill cancer cells, including oncolytic viruses, peptide vaccines, cell therapies, and checkpoint inhibitors. The presentation outlines Targovax's clinical trial pipeline and strategy, including trials of ONCOS-102 in CPI-refractory melanoma and mesothelioma and TG01 in resected pancreatic and colorectal cancers. Near-term value drivers include TG01 two-year survival data in pancreatic cancer in 1H2017 and ONCOS-102 interim data in melanoma in 2H2017.
Targovax is developing immunotherapies to help the immune system fight cancer. They have six ongoing clinical trials combining their oncolytic adenovirus or peptide vaccines with checkpoint inhibitors or chemotherapy. They expect readouts from four of these trials in 2017-2018, which will be important value inflection points. Encouraging survival data was seen in a Phase I/II trial of their peptide vaccine TG01 in resected pancreatic cancer patients.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
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 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.
- 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
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
Corporate Presentation TiGenix - September 2014TiGenix
This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of the Company.
This document may contain forward-looking statements and estimates made by the Company, including with respect to the anticipated future performance of TiGenix and the market in which it operates. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speak as of the date of this document and no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based.
OBI Pharma presentation at JP Morgan Healthcare Conference 2018Gus Adapon, ELS
The document contains a safe harbor statement regarding forward-looking statements and outlines 11 factors that could cause actual results to differ from forward-looking statements. It also notes that earnings growth statements are not profit forecasts. The presentation summarizes the 36th J.P. Morgan Annual Healthcare Conference, including key highlights on Adagloxad Simolenin such as constructive EOP2 meetings with regulators and a proposed global phase 3 trial design. It also provides updates on OBI's expanding oncology portfolio through passive immunotherapy, antibody drug conjugates, and small molecule programs.
- Sanofi's CEO Olivier Brandicourt presented at a healthcare conference on September 14, 2018.
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- Brandicourt highlighted several potentially significant drug approvals and trial results for new drugs and indications expected over the next 12 months that could further advance Sanofi's growth.
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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
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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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Methanex is the world's largest producer and supplier of methanol. We create value through our leadership in the global production, marketing and delivery of methanol to customers. View our latest Investor Presentation for more details.
Cleades Robinson, a respected leader in Philadelphia's police force, is known for his diplomatic and tactful approach, fostering a strong community rapport.
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UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
2. Forward Looking 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. Company Highlights
3
• Clinical stage biopharmaceutical company targeting inflammatory-mediated and
infectious diseases with oral immunotherapies
• Validated technology platform – with one registered asset generating revenue
• 2 Lead clinical assets in Phase 2 development for the treatment of multiple high value
indications, Fat Liver Disease and CDI.
• Excellent safety profile, GRAS by FDA, expedited regulatory review and approval
process
• Well positioned to address high unmet medical need in multiple blockbuster markets
• High-value peer licensing deals and M&A underscore potential upside
• Company listed on NASDAQ in 2Q 2017
• Experienced Management Team and strong support from leading KOLs and
institutions (NIH, DoD)
4. Experienced Management Team
4
Jerry Kanellos, PhD
Chief Executive 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 was CEO of
Avipep Pty Ltd a privately owned oncology
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.
Travis Robins
US Sales Director
Mr. Robins is an accomplished, motivated
leader with progressive years of proven
success in dramatically increasing revenues
and expanding market shares, while building
key relationships.
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 President of the
AASLD. Current Chair 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 Immunoglobulins: 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 producing multiple drug candidates Long-term value creation
• Regulated as biologics by the FDA 12 years exclusivity in the US for each approval
• Unique technology offering protection from future generic biosimilar market erosion
• Safety established Generally Regarded As Safe (GRAS) by FDA, accelerated approval
process
• Low manufacturing costs ~ $1 / gram compared with > $100 / gram for MAb
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 reported 2Q 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 with Dr. Rogler, Zurich
University
IMM-124E Autism
Murdoch Childrens Research
Institue,
La Trobe & RMIT Universities
Anti-Infective Programs
IMM-529 C. difficile Phase 1/2 Expected to start 3Q 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
• Targeted antibodies mediate broad anti-inflammatory mechanism of action
- 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 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 target all 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 President of AASLD (American Association for the Study
of Liver Diseases) and current Chair 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: 133 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 Activated Macrophages (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 ALT level
- Improved metabolic status for IG and IMM-124E treated mice (i.e. TG, Fasting
Glucose and OGTT)
- Anti-inflammatory shift: Decreased TNF-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 Liver Activated 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
20. IMM-124E Interim analysis
21
• Goal: Validate Safety and test for futility
• Analysis was not powered for efficacy due to sample size
• Design: interim analysis initiated when 80 patients reached 24W and have 2 MRI
• Execution: Performed by an independent Committee to keep Company Blinded
• Results:
• Excellent Safety
• Treatment well tolerated at both doses
• No Futility
• Significant change in ALT and AST at 24W
• Significant reduction in ALT and AST over time compared to placebo
• Dose response
• Non-absorbable
21. Phase II: Interim Analysis Report - Improves
Liver Function
22
Results of a Phase IIa clinical trial; N=133
24 Week Treatment; NO SAFETY ISSUES REPORTED
Change in ALT by treatment group and visit (FAS population)
• When comparing the 24W values
of serum ALT to baseline all arms
demonstrate a significant
reduction
• However the change over time is
different across the study arms
0 28 56 84 112 140 168 196
Study Day
-20
-10
0
10
ChangeinALT(U/L)fromDay0
Placebo600mg1200mg
LS Mean ± Std Err from RMMM on Change
Differences (p < 0.05): # Placebo v either active, + 600mg v 1200mg, * 1200 v 600 and Placebo
22. Phase II: Interim Analysis Report - Improves
Liver Function
23
Results of a Phase IIa clinical trial; N=133
24 Week Treatment; NO SAFETY ISSUES REPORTED
Box plot for predicted ALT AUC from ANCOVA (FAS population)
Improved Liver Enzymes
• Using logarithmic regression
the predicted value was used
• Both 1200 mg and 600 mg
arms demonstrated
significant change over
placebo (p=0.0036 and
p=0.0075)
• but were not different from
one another (p=0.3589)
-8000
-6000
-4000
-2000
0
2000
PredictedvalueforALTAUC
Placebo600mg1200mgGroup
Predicted value adjusted for Baseline ALT
25. IMM-529 in Clostridium difficile Infection (CDI)
26
• Biologic with unique triple mechanism of action
- Targets and neutralizes the toxin B, the spores and the vegetative cells
• Potential to redefine the standard-of-care (SOC) therapy for CDI
- 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)
26. IMM-529 for the Treatment of CDI
27
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 current standard of care, accounting for 80% of
patient share (US)
• However, therapies are plagued by significant CDI recurrences (1st relapse: 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 of care
• Targets many isolates
Sources: GlobalData, Decision Resources, CDC
27. Triple Action MOA
Neutralizing C. difficile; Sparing the Microbiome
28
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 bacterial colonization.
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 systemic circulation and
inflammatory cascades.
Toxin B is essential for
virulence. Toxin B disrupt the
cytoskeleton and tight
junctions of intestinal epithelial
cells.
3
1
2
28. Results of Pre-Clinical Studies
29
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 ~20%
relapse rate vs.
~89% relapse 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
29. Phase 1/2 Study Design
30
• 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 overall
• 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 3Q 2017
30. • 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
31
2Q/3Q
2017
2018
32. Robust IP and Extended Market Protection
33
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
33. • 2016: Licensed preclinical
NASH asset
• ~$50M upfront + other
undisclosed milestones
Recent High-Value NASH LM&A Highlights
Potential for Significant Upside
34
• 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
34. NASH and C. difficile Comps Indicate
Potential for Substantial Growth
35
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
35. Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)
36
Current Top 10 Shareholders
Current Company
Market Capitalization
AUD$23.4M ≈ USD$18.6M (8th Aug 2017)
Rank Holder Name Current Qty %
1 HSBC CUSTODY NOM AUST LTD (ADR Program) 19,531,706 14.97%
2 * GRANDLODGE PL 9,056,682 6.94%
3 AUTHENTICS AUST PL 8,624,999 6.61%
4 RETZOS EXECUTIVE PL 3,800,000 2.91%
5 * ANASTASIOU PETER + K P 2,907,236 2.23%
6 INVERAREY PL 2,731,632 2.09%
7 * FIFTY-FIFTH LEPRECHAUN PL 2,645,983 2.03%
8 INSYNC INV PL 2,500,000 1.92%
9 SBI INV PR LLC 2,000,000 1.53%
10 ADVANCE PUBLICITY PL 2,000,000 1.53%
TOTAL TOP 20 SHAREHOLDERS 55,798,238 42.76%
BALANCE OF SHARES 74,642,224 57.24%
TOTAL SHARE ON ISSUE 130,440,462 100.00%
* Denotes a Director Related Entity
36. Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)
Issued Capital
Recent Share
Price Activity
130,440,462 Issue Shares (Fully Paid)
25,289,894 Listed Options exercisable at AUD$0.55 on or before 30 Nov 2019
701,500 Warrants exercisable at USD$10 on or before 13 June 2022 (40:1)
9,937,629 Unlisted Options exercisable at various prices
Close of Recruitment of Phase II NASH Trial
Positive Results of IMM-124E in Acute Colitis Studies
IMC Expands Agreement with US Army - 3 Additional Therapeutics
Travelan Increases Industry Presence
NASH Phase II Interim Analysis Success
NASDAQ Listing
37. Travelan OTC/Business
A unique OTC targeting Traveler’s Diarrhea
• Travelan/OTC: Unique value proposition that is valued by consumers and customers
- 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+
38
38. Key Milestones Expected to Drive Value
39
• IMM-529
- Clinical supplies
manufacturing
• IMM-124E
- NASH Phase 2
interim analyses
- SanyalBio – NASH
MOA
• IMM-529
- Initiation of Phase
1/2 Trial in CDI
• 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 expected 2017/2018
39. Investment Highlights
40
✓ Well positioned to address high unmet medical need in multiple
blockbuster markets
✓ Two clinical assets, 4 phase 2 clinical trials on going
✓ Robust R&D pipeline
✓ High-value peer licensing deals and M&A underscore potential
upside ( Current Market Capitalization = USD$18.6M, 6 August
2017)
✓ Validated technology platform – with one registered asset
generating growing revenue
✓ Listed on NASDAQ in 2Q 2017
✓ Experienced Management Team with strong support from
leading KOLs and institutions