Opexa Therapeutics is developing Tcelna, a precision immunotherapy for the treatment of multiple sclerosis (MS). Tcelna consists of attenuated antigen-specific T-cell clones that are designed to program the immune system to target pathogenic myelin reactive T-cells (MRTC) that cause damage in MS. Opexa has completed enrollment in a Phase IIb clinical trial of Tcelna in secondary progressive MS (SPMS) and expects top-line data in mid-2016. The company has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments if certain development and sales milestones are achieved.
Opexa therapeutics corporate presentation march 2014OpexaTherapeutics
Opexa Therapeutics is developing Tcelna, a precision immunotherapy, for the treatment of secondary progressive multiple sclerosis (SPMS). Tcelna consists of attenuated myelin reactive T-cell clones that are believed to trigger an immune response targeting pathogenic myelin reactive T-cells. Opexa has an ongoing Phase IIb clinical trial of Tcelna in SPMS and expects to complete enrollment in mid-2014, with top-line data expected in mid-2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments.
Opexa Therapeutics is developing Tcelna, a precision immunotherapy for the treatment of secondary progressive multiple sclerosis (SPMS). Tcelna consists of attenuated myelin-reactive T-cell clones that are designed to program the immune system to target pathogenic myelin-reactive T-cells. Opexa has an ongoing Phase IIb clinical trial of Tcelna in SPMS and expects to complete enrollment in mid-2014, with top-line data expected in mid-2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments.
Opexa Therapeutics is developing Tcelna, an autologous T-cell immunotherapy, for the treatment of secondary progressive multiple sclerosis (SPMS). They are currently conducting a Phase IIb clinical trial of Tcelna in SPMS patients. Preliminary data from earlier trials in both relapsing-remitting and SPMS patients showed signs of efficacy, including reduced disability progression, brain atrophy, and relapse rates. If successful, Tcelna has the potential to be the first approved treatment specifically for SPMS, an underserved market with no approved therapies. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $
Opexa Therapeutics Corporate Presentation - May 2013OpexaTherapeutics
Opexa Therapeutics is developing Tcelna, a personalized immunotherapy for the treatment of multiple sclerosis (MS). Tcelna aims to specifically target myelin-reactive T-cells (MRTCs) that cause damage to the myelin sheath in MS patients. Clinical trials have shown Tcelna reduces MRTCs and relapses in both relapsing-remitting and secondary progressive MS patients. Opexa has an agreement with Merck for the development of Tcelna in MS that could provide up to $220 million in milestones for Opexa.
Opexa Therapeutics is developing Precision Immunotherapy using Tcelna to treat multiple sclerosis (MS). Tcelna is an antigen-specific T-cell immunotherapy that targets myelin-reactive T-cells that cause damage in MS. It is currently in a Phase IIb clinical trial called Abili-T for secondary progressive MS (SPMS), which has limited treatment options. Previous clinical trials of Tcelna showed reductions in brain atrophy, disability progression, and relapse rates in SPMS patients. If successful, Abili-T could support Tcelna becoming the first approved treatment for SPMS.
Opexa Therapeutics is developing Precision Immunotherapy using Tcelna to treat multiple sclerosis (MS). Tcelna is an antigen specific T-cell immunotherapy that targets myelin reactive T-cells (MRTCs) that cause damage in MS. Opexa is currently conducting a Phase IIb clinical trial of Tcelna in secondary progressive MS (SPMS) called Abili-T. Previous clinical trials of Tcelna showed promising results in reducing brain atrophy, disability progression, and relapse rates in MS patients. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS, which could provide up to $220 million in payments if milestones are
Opexa therapeutics corporate presentation december 16OpexaTherapeutics
Tcelna is a precision immunotherapy under development by Opexa Therapeutics for the treatment of secondary progressive multiple sclerosis (SPMS). It is currently being tested in a Phase IIb clinical trial called Abili-T that aims to enroll 180 patients to receive two annual courses of treatment. The primary endpoint is reduction in whole brain atrophy, with secondary endpoints including measures of disability progression, relapse rate, and lesion activity. Positive results from previous trials support Tcelna's mechanism of reducing myelin-reactive T-cells and stabilizing disease progression in SPMS patients. An option agreement with Merck Serono provides the potential for commercialization if successful.
Opexa Therapeutics provides a summary of its precision immunotherapy platform and clinical programs. Key points include:
- Tcelna in development for multiple sclerosis, with a Phase 2b trial ongoing in secondary progressive MS. Topline data expected in 2016.
- Pipeline expansion includes OPX-212 for neuromyelitis optica, with IND submission planned for mid-2015.
- Clinical trials show Tcelna reduces myelin reactive T-cells and improved outcomes for relapsing remitting MS patients versus placebo in Phase 2b trials.
- Agreement with Merck Serono provides potential for commercial partnership if Phase 3 is initiated for multiple sclerosis indications.
Opexa therapeutics corporate presentation march 2014OpexaTherapeutics
Opexa Therapeutics is developing Tcelna, a precision immunotherapy, for the treatment of secondary progressive multiple sclerosis (SPMS). Tcelna consists of attenuated myelin reactive T-cell clones that are believed to trigger an immune response targeting pathogenic myelin reactive T-cells. Opexa has an ongoing Phase IIb clinical trial of Tcelna in SPMS and expects to complete enrollment in mid-2014, with top-line data expected in mid-2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments.
Opexa Therapeutics is developing Tcelna, a precision immunotherapy for the treatment of secondary progressive multiple sclerosis (SPMS). Tcelna consists of attenuated myelin-reactive T-cell clones that are designed to program the immune system to target pathogenic myelin-reactive T-cells. Opexa has an ongoing Phase IIb clinical trial of Tcelna in SPMS and expects to complete enrollment in mid-2014, with top-line data expected in mid-2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments.
Opexa Therapeutics is developing Tcelna, an autologous T-cell immunotherapy, for the treatment of secondary progressive multiple sclerosis (SPMS). They are currently conducting a Phase IIb clinical trial of Tcelna in SPMS patients. Preliminary data from earlier trials in both relapsing-remitting and SPMS patients showed signs of efficacy, including reduced disability progression, brain atrophy, and relapse rates. If successful, Tcelna has the potential to be the first approved treatment specifically for SPMS, an underserved market with no approved therapies. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $
Opexa Therapeutics Corporate Presentation - May 2013OpexaTherapeutics
Opexa Therapeutics is developing Tcelna, a personalized immunotherapy for the treatment of multiple sclerosis (MS). Tcelna aims to specifically target myelin-reactive T-cells (MRTCs) that cause damage to the myelin sheath in MS patients. Clinical trials have shown Tcelna reduces MRTCs and relapses in both relapsing-remitting and secondary progressive MS patients. Opexa has an agreement with Merck for the development of Tcelna in MS that could provide up to $220 million in milestones for Opexa.
Opexa Therapeutics is developing Precision Immunotherapy using Tcelna to treat multiple sclerosis (MS). Tcelna is an antigen-specific T-cell immunotherapy that targets myelin-reactive T-cells that cause damage in MS. It is currently in a Phase IIb clinical trial called Abili-T for secondary progressive MS (SPMS), which has limited treatment options. Previous clinical trials of Tcelna showed reductions in brain atrophy, disability progression, and relapse rates in SPMS patients. If successful, Abili-T could support Tcelna becoming the first approved treatment for SPMS.
Opexa Therapeutics is developing Precision Immunotherapy using Tcelna to treat multiple sclerosis (MS). Tcelna is an antigen specific T-cell immunotherapy that targets myelin reactive T-cells (MRTCs) that cause damage in MS. Opexa is currently conducting a Phase IIb clinical trial of Tcelna in secondary progressive MS (SPMS) called Abili-T. Previous clinical trials of Tcelna showed promising results in reducing brain atrophy, disability progression, and relapse rates in MS patients. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS, which could provide up to $220 million in payments if milestones are
Opexa therapeutics corporate presentation december 16OpexaTherapeutics
Tcelna is a precision immunotherapy under development by Opexa Therapeutics for the treatment of secondary progressive multiple sclerosis (SPMS). It is currently being tested in a Phase IIb clinical trial called Abili-T that aims to enroll 180 patients to receive two annual courses of treatment. The primary endpoint is reduction in whole brain atrophy, with secondary endpoints including measures of disability progression, relapse rate, and lesion activity. Positive results from previous trials support Tcelna's mechanism of reducing myelin-reactive T-cells and stabilizing disease progression in SPMS patients. An option agreement with Merck Serono provides the potential for commercialization if successful.
Opexa Therapeutics provides a summary of its precision immunotherapy platform and clinical programs. Key points include:
- Tcelna in development for multiple sclerosis, with a Phase 2b trial ongoing in secondary progressive MS. Topline data expected in 2016.
- Pipeline expansion includes OPX-212 for neuromyelitis optica, with IND submission planned for mid-2015.
- Clinical trials show Tcelna reduces myelin reactive T-cells and improved outcomes for relapsing remitting MS patients versus placebo in Phase 2b trials.
- Agreement with Merck Serono provides potential for commercial partnership if Phase 3 is initiated for multiple sclerosis indications.
Opexa Therapeutics is developing Precision Immunotherapy using attenuated myelin reactive T-cell clones (Tcelna) to treat multiple sclerosis. Tcelna is designed to program the immune system to target pathogenic myelin reactive T-cells that cause demyelination. Opexa has completed enrollment in a Phase IIb clinical trial of Tcelna in 190 patients with secondary progressive multiple sclerosis, with top-line data expected in late 2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in multiple sclerosis that could provide up to $220 million in payments if milestones are achieved.
Opexa therapeutics corporate presentation november 21OpexaTherapeutics
Opexa Therapeutics is developing Precision Immunotherapy using their T-cell platform to treat autoimmune diseases like multiple sclerosis. Their lead product Tcelna is in Phase 2 clinical trials for secondary progressive multiple sclerosis, a later stage form of MS with limited treatment options. Tcelna works by specifically targeting and reducing myelin reactive T-cells that cause damage to the protective myelin sheath surrounding nerves. If successful, Tcelna has the potential to be the first treatment approved for secondary progressive MS and generate over $7 billion in annual sales. Opexa has an option agreement with Merck for the development of Tcelna in MS.
Opexa Therapeutics is developing Precision Immunotherapy using their T-cell platform to treat autoimmune diseases like multiple sclerosis (MS). Their lead product, Tcelna, is in Phase II clinical trials for secondary progressive MS (SPMS), which affects around 30-45% of MS patients. Tcelna works by programming the immune system to specifically recognize and inhibit myelin reactive T-cells that cause damage to the protective myelin sheath surrounding nerves. If successful, Tcelna could be the first approved treatment for SPMS, representing a potential $7 billion market in North America alone. Opexa has an option agreement with Merck for the development of Tcelna in MS.
Opexa therapeutics corporate presentation january 2OpexaTherapeutics
Opexa Therapeutics is developing Precision Immunotherapy called Tcelna to treat Secondary Progressive Multiple Sclerosis (SPMS). Tcelna aims to specifically target myelin-reactive T-cells that cause damage in MS, without broadly suppressing the immune system. An ongoing Phase IIb trial called Abili-T is testing Tcelna in 180 patients with SPMS over 24 months. The primary endpoint is reduction in brain atrophy. Secondary endpoints include disability progression, relapse rate, and lesion measures. Positive results could support Tcelna as a novel treatment for the underserved SPMS population.
Opexa therapeutics corporate presentation september 2016OpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their lead asset, Tcelna, is in Phase 2b development for secondary progressive multiple sclerosis and top-line data is expected in the next 1-2 months. They are also developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies. Opexa has secured an option agreement with Merck Serono for Tcelna in MS and could receive up to $25 million in milestones if Merck exercises their option after seeing Phase 2b data.
Opexa therapeutics corporate presentation october 2014OpexaTherapeutics
Opexa Therapeutics is developing Tcelna, an autologous T cell immunotherapy, for the treatment of multiple sclerosis (MS). A Phase 2b clinical trial of Tcelna in secondary progressive MS (SPMS) is ongoing, with top-line results expected in late 2016. Previous clinical trials of Tcelna in relapsing-remitting MS showed a 37% reduction in relapse rate compared to placebo and reversal of disability progression in more active patients. Opexa signed an agreement with Merck Serono for development and commercialization of Tcelna in MS worldwide, excluding Japan, which could provide over $220 million in milestones to Opexa.
Opexa Therapeutics is conducting a Phase IIb clinical trial of its T-cell immunotherapy Tcelna to treat Secondary Progressive Multiple Sclerosis (SPMS). The company recently signed an option agreement with Merck Serono that could provide up to $225 million in payments if Merck exercises its option to acquire rights to Tcelna in MS. Opexa is also exploring opportunities to develop Tcelna and its stem cell platform in other autoimmune diseases. The ongoing Phase IIb trial is evaluating Tcelna's ability to reduce brain atrophy and progression in 180 SPMS patients over two years.
Opexa Therapeutics Corporate Presentation September 2015OpexaTherapeutics
Opexa Therapeutics presented information on their Precision Immunotherapy platform and lead programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown promise in reducing reactive T-cells and relapse rates in prior studies. Their platform also aims to develop OPX-212 as a potential first-in-class therapy for neuromyelitis optica, an orphan disease with no approved treatments. Opexa has an option agreement with Merck Serono for Tcelna in multiple sclerosis and recently secured $5 million in funding to advance OPX-212 into clinical studies.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
Opexa Therapeutics Corporate Presentation October 2015OpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy programs, Tcelna and OPX-212. Tcelna is in a Phase 2b clinical trial for secondary progressive multiple sclerosis and has shown a 37% reduction in relapses in prior trials. OPX-212 is being developed for neuromyelitis optica, an orphan disease with no approved therapies. Opexa expects to file an IND for OPX-212 by the end of 2015 after completing preclinical studies. The company highlighted their personalized T-cell immunotherapy platform, clinical progress, pipeline expansion opportunities, and management team experience in drug development.
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET) as a potential third line therapy. Phase 1 and 2 clinical trials showed that GALE-401 maintains platelet lowering effects while reducing peak plasma concentrations and adverse events compared to immediate release anagrelide. The company plans to initiate a Phase 3 trial in Q2 2017 to further evaluate GALE-401 in ET patients who are intolerant or refractory to first and second line therapies such as hydroxyurea and anagrelide.
1) TapImmune and Marker Therapeutics plan to merge, with TapImmune renaming and relocating its headquarters to Houston.
2) The combined company will have multiple clinical trials underway testing a novel T cell therapy approach that targets multiple tumor antigens without genetic modification of cells.
3) This multi-antigen approach aims to provide durable responses, prevent immune escape, reduce costs and complexity compared to CAR-T and TCR therapies, and has shown a superior toxicity profile in over 50 treated patients so far.
Opexa therapeutics corporate presentation february 2016 webOpexaTherapeutics
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead program, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has received Fast Track designation from the FDA. Opexa is also developing OPX-212 for neuromyelitis optica, an orphan disease with no approved therapies. Preclinical studies of OPX-212 showed a statistically significant reduction in pathogenic T-cells. Topline results for Tcelna in SPMS are expected in the second half of 2016, which would be a key inflection point if positive.
Opexa therapeutics corporate presentation march 2016OpexaTherapeutics
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Its lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has potential partnerships with Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica, an orphan disease with no approved therapies. Preclinical studies show OPX-212 reduces pathogenic T-cells in animal models. Opexa's platform aims to selectively eliminate harmful immune cells while leaving the rest of the immune system intact.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in a Phase 2b clinical trial for secondary progressive multiple sclerosis (SPMS) with top-line results expected in early Q4 2016. Tcelna uses the proprietary ImmPath platform to prime the immune system to target disease-causing T-cells. Previous clinical trials of Tcelna showed a significant reduction in myelin reactive T-cells and a 37% improvement over placebo in annualized relapse rate for relapsing-remitting MS. Opexa has an option agreement with Merck Serono for worldwide rights to develop Tcelna for MS indications.
Opexa therapeutics corporate presentation july 2016OpexaTherapeutics
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in a Phase 2b clinical trial for secondary progressive multiple sclerosis, with top-line results expected in early Q4 2016. Their platform also supports OPX-212 for neuromyelitis optica, an orphan disease with no approved therapies. Opexa has secured an option agreement with Merck Serono for Tcelna in multiple sclerosis and has established preclinical validation of their approach in animal models of disease.
This document provides an overview and disclaimer for a company called Abakan Inc. It discusses Abakan's technology for applying corrosion-resistant coatings to pipes, which could address a multi-billion dollar market opportunity. The document outlines Abakan's intellectual property portfolio, recent development milestones, potential customers in various industries, and the large market size for addressing the global corrosion problem. It disclaims any promises or warranties regarding investment details and requests that the information be kept confidential.
The document discusses ChromaDex's forward-looking statements and FDA disclaimer. It then provides an overview of ChromaDex's mission to commercialize patented ingredient technologies, including nicotinamide riboside, pTeroPure, pterostilbene, and anthocyanins, in multi-billion dollar markets like dietary supplements and food and beverage. ChromaDex also has an established legacy business providing analytical testing services and natural products.
This document provides a business update from CombiMatrix Corporation for January 2014. It summarizes CombiMatrix's strategy of providing clinical support services in prenatal genetics, pediatric disorders, and oncology using microarray platforms, karyotyping, and FISH technologies. The management team is highlighted, including the President & CEO who has extensive experience in diagnostic sales. Recent highlights include a partnership with Sequenom to market prenatal microarray testing and third quarter 2013 financial results.
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.
The document discusses Direct Insite, a company that provides cloud-based accounts payable and accounts receivable automation solutions. It notes that some statements may be forward-looking and discusses risks associated with such statements. It then provides an overview of Direct Insite's solutions, customers, and competitive advantages. Key points include its large network of over 450,000 suppliers and customers transacting over $130 billion annually, and its goal to achieve over 10% annual revenue growth through 2015 by expanding its sales force and introducing new products.
Opexa Therapeutics is developing Precision Immunotherapy using attenuated myelin reactive T-cell clones (Tcelna) to treat multiple sclerosis. Tcelna is designed to program the immune system to target pathogenic myelin reactive T-cells that cause demyelination. Opexa has completed enrollment in a Phase IIb clinical trial of Tcelna in 190 patients with secondary progressive multiple sclerosis, with top-line data expected in late 2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in multiple sclerosis that could provide up to $220 million in payments if milestones are achieved.
Opexa therapeutics corporate presentation november 21OpexaTherapeutics
Opexa Therapeutics is developing Precision Immunotherapy using their T-cell platform to treat autoimmune diseases like multiple sclerosis. Their lead product Tcelna is in Phase 2 clinical trials for secondary progressive multiple sclerosis, a later stage form of MS with limited treatment options. Tcelna works by specifically targeting and reducing myelin reactive T-cells that cause damage to the protective myelin sheath surrounding nerves. If successful, Tcelna has the potential to be the first treatment approved for secondary progressive MS and generate over $7 billion in annual sales. Opexa has an option agreement with Merck for the development of Tcelna in MS.
Opexa Therapeutics is developing Precision Immunotherapy using their T-cell platform to treat autoimmune diseases like multiple sclerosis (MS). Their lead product, Tcelna, is in Phase II clinical trials for secondary progressive MS (SPMS), which affects around 30-45% of MS patients. Tcelna works by programming the immune system to specifically recognize and inhibit myelin reactive T-cells that cause damage to the protective myelin sheath surrounding nerves. If successful, Tcelna could be the first approved treatment for SPMS, representing a potential $7 billion market in North America alone. Opexa has an option agreement with Merck for the development of Tcelna in MS.
Opexa therapeutics corporate presentation january 2OpexaTherapeutics
Opexa Therapeutics is developing Precision Immunotherapy called Tcelna to treat Secondary Progressive Multiple Sclerosis (SPMS). Tcelna aims to specifically target myelin-reactive T-cells that cause damage in MS, without broadly suppressing the immune system. An ongoing Phase IIb trial called Abili-T is testing Tcelna in 180 patients with SPMS over 24 months. The primary endpoint is reduction in brain atrophy. Secondary endpoints include disability progression, relapse rate, and lesion measures. Positive results could support Tcelna as a novel treatment for the underserved SPMS population.
Opexa therapeutics corporate presentation september 2016OpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their lead asset, Tcelna, is in Phase 2b development for secondary progressive multiple sclerosis and top-line data is expected in the next 1-2 months. They are also developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies. Opexa has secured an option agreement with Merck Serono for Tcelna in MS and could receive up to $25 million in milestones if Merck exercises their option after seeing Phase 2b data.
Opexa therapeutics corporate presentation october 2014OpexaTherapeutics
Opexa Therapeutics is developing Tcelna, an autologous T cell immunotherapy, for the treatment of multiple sclerosis (MS). A Phase 2b clinical trial of Tcelna in secondary progressive MS (SPMS) is ongoing, with top-line results expected in late 2016. Previous clinical trials of Tcelna in relapsing-remitting MS showed a 37% reduction in relapse rate compared to placebo and reversal of disability progression in more active patients. Opexa signed an agreement with Merck Serono for development and commercialization of Tcelna in MS worldwide, excluding Japan, which could provide over $220 million in milestones to Opexa.
Opexa Therapeutics is conducting a Phase IIb clinical trial of its T-cell immunotherapy Tcelna to treat Secondary Progressive Multiple Sclerosis (SPMS). The company recently signed an option agreement with Merck Serono that could provide up to $225 million in payments if Merck exercises its option to acquire rights to Tcelna in MS. Opexa is also exploring opportunities to develop Tcelna and its stem cell platform in other autoimmune diseases. The ongoing Phase IIb trial is evaluating Tcelna's ability to reduce brain atrophy and progression in 180 SPMS patients over two years.
Opexa Therapeutics Corporate Presentation September 2015OpexaTherapeutics
Opexa Therapeutics presented information on their Precision Immunotherapy platform and lead programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown promise in reducing reactive T-cells and relapse rates in prior studies. Their platform also aims to develop OPX-212 as a potential first-in-class therapy for neuromyelitis optica, an orphan disease with no approved treatments. Opexa has an option agreement with Merck Serono for Tcelna in multiple sclerosis and recently secured $5 million in funding to advance OPX-212 into clinical studies.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
Opexa Therapeutics Corporate Presentation October 2015OpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy programs, Tcelna and OPX-212. Tcelna is in a Phase 2b clinical trial for secondary progressive multiple sclerosis and has shown a 37% reduction in relapses in prior trials. OPX-212 is being developed for neuromyelitis optica, an orphan disease with no approved therapies. Opexa expects to file an IND for OPX-212 by the end of 2015 after completing preclinical studies. The company highlighted their personalized T-cell immunotherapy platform, clinical progress, pipeline expansion opportunities, and management team experience in drug development.
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET) as a potential third line therapy. Phase 1 and 2 clinical trials showed that GALE-401 maintains platelet lowering effects while reducing peak plasma concentrations and adverse events compared to immediate release anagrelide. The company plans to initiate a Phase 3 trial in Q2 2017 to further evaluate GALE-401 in ET patients who are intolerant or refractory to first and second line therapies such as hydroxyurea and anagrelide.
1) TapImmune and Marker Therapeutics plan to merge, with TapImmune renaming and relocating its headquarters to Houston.
2) The combined company will have multiple clinical trials underway testing a novel T cell therapy approach that targets multiple tumor antigens without genetic modification of cells.
3) This multi-antigen approach aims to provide durable responses, prevent immune escape, reduce costs and complexity compared to CAR-T and TCR therapies, and has shown a superior toxicity profile in over 50 treated patients so far.
Opexa therapeutics corporate presentation february 2016 webOpexaTherapeutics
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead program, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has received Fast Track designation from the FDA. Opexa is also developing OPX-212 for neuromyelitis optica, an orphan disease with no approved therapies. Preclinical studies of OPX-212 showed a statistically significant reduction in pathogenic T-cells. Topline results for Tcelna in SPMS are expected in the second half of 2016, which would be a key inflection point if positive.
Opexa therapeutics corporate presentation march 2016OpexaTherapeutics
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Its lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has potential partnerships with Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica, an orphan disease with no approved therapies. Preclinical studies show OPX-212 reduces pathogenic T-cells in animal models. Opexa's platform aims to selectively eliminate harmful immune cells while leaving the rest of the immune system intact.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in a Phase 2b clinical trial for secondary progressive multiple sclerosis (SPMS) with top-line results expected in early Q4 2016. Tcelna uses the proprietary ImmPath platform to prime the immune system to target disease-causing T-cells. Previous clinical trials of Tcelna showed a significant reduction in myelin reactive T-cells and a 37% improvement over placebo in annualized relapse rate for relapsing-remitting MS. Opexa has an option agreement with Merck Serono for worldwide rights to develop Tcelna for MS indications.
Opexa therapeutics corporate presentation july 2016OpexaTherapeutics
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in a Phase 2b clinical trial for secondary progressive multiple sclerosis, with top-line results expected in early Q4 2016. Their platform also supports OPX-212 for neuromyelitis optica, an orphan disease with no approved therapies. Opexa has secured an option agreement with Merck Serono for Tcelna in multiple sclerosis and has established preclinical validation of their approach in animal models of disease.
This document provides an overview and disclaimer for a company called Abakan Inc. It discusses Abakan's technology for applying corrosion-resistant coatings to pipes, which could address a multi-billion dollar market opportunity. The document outlines Abakan's intellectual property portfolio, recent development milestones, potential customers in various industries, and the large market size for addressing the global corrosion problem. It disclaims any promises or warranties regarding investment details and requests that the information be kept confidential.
The document discusses ChromaDex's forward-looking statements and FDA disclaimer. It then provides an overview of ChromaDex's mission to commercialize patented ingredient technologies, including nicotinamide riboside, pTeroPure, pterostilbene, and anthocyanins, in multi-billion dollar markets like dietary supplements and food and beverage. ChromaDex also has an established legacy business providing analytical testing services and natural products.
This document provides a business update from CombiMatrix Corporation for January 2014. It summarizes CombiMatrix's strategy of providing clinical support services in prenatal genetics, pediatric disorders, and oncology using microarray platforms, karyotyping, and FISH technologies. The management team is highlighted, including the President & CEO who has extensive experience in diagnostic sales. Recent highlights include a partnership with Sequenom to market prenatal microarray testing and third quarter 2013 financial results.
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.
The document discusses Direct Insite, a company that provides cloud-based accounts payable and accounts receivable automation solutions. It notes that some statements may be forward-looking and discusses risks associated with such statements. It then provides an overview of Direct Insite's solutions, customers, and competitive advantages. Key points include its large network of over 450,000 suppliers and customers transacting over $130 billion annually, and its goal to achieve over 10% annual revenue growth through 2015 by expanding its sales force and introducing new products.
Energy Fuels is the nation's leading conventional uranium producer, supplying approximately 25% of the uranium produced in the U.S. (based on FY-2013 deliveries). The Company also has the capability to be a significant producer of vanadium. Energy Fuels owns and operates the White Mesa Mill, which is the only conventional uranium mill currently operating in the U.S. The mill is capable of processing 2,000 tons per day of uranium ore and producing up to 8 million lbs. of U3O8 per year (depending on ore grade).
This document discusses Biocept, Inc., a commercial-stage cancer diagnostics company. It provides an overview of Biocept's liquid biopsy platform and tests, including OncoCEE and OncoCEE-BR, which measure circulating tumor cells. The document highlights Biocept's multi-faceted growth strategy including test menu expansion and increasing operational efficiency. It also introduces Biocept's executive team and discusses the large US market opportunity for cancer diagnostics.
The nuclear energy industry has lain stagnant for over 30 years and has suffered from missteps and perception issues.
Lightbridge is here to innovate and change the conversation. About: Lightbridge is a U.S. nuclear energy company based in McLean, Virginia with operations in Abu Dhabi, Moscow and London. The Company develops proprietary, proliferation resistant, next generation nuclear fuel technologies for current and future nuclear reactor systems. The Company also provides comprehensive advisory services for established and emerging nuclear programs based on a philosophy of transparency, non-proliferation, safety and operational excellence. Lightbridge's breakthrough fuel technology is establishing new global standards for safe and clean nuclear power and leading the way to a sustainable energy future. Lightbridge consultants provide integrated strategic advice and expertise across a range of disciplines including regulatory affairs, nuclear reactor procurement and deployment, reactor and fuel technology and international relations. The Company leverages those broad and integrated capabilities by offering its services to commercial entities and governments with a need to establish or expand nuclear industry capabilities and infrastructure.
Genius Brands International is a company focused on providing children's entertainment content with purpose for toddlers to tweens. It was created through the merger of A Squared Entertainment and Genius Brands. The document discusses Genius Brands' plans to grow its portfolio of animated properties like Baby Genius, Warren Buffett's Secret Millionaires Club, and new shows in partnership with Stan Lee and Martha Stewart. It aims to distribute this content across television, online, mobile and through a new streaming service, while supporting the content through consumer products licensing. The management team, including Andy and Amy Heyward, have decades of experience in the children's entertainment industry.
Lightbridge Corporation is an innovative nuclear fuel technology company that has developed a new metallic nuclear fuel design. The new fuel design provides several benefits including increased power output from existing reactors, improved safety, and reduced costs. Lightbridge has validated the technology and economics through third-party analyses and has an MOU with Babcock & Wilcox to develop a pilot fuel fabrication plant. The company also has a successful nuclear advisory services business and plans to license the new fuel technology globally. Lightbridge has an experienced management team and board of advisors with extensive experience in the nuclear industry.
Spherix generates revenue through acquiring and licensing patent portfolios. It has over 200 patents of its own covering various industries and is engaged in ongoing licensing campaigns. It has a relationship with Rockstar Consortium, which gives it access to over 4000 additional patents. Spherix recently acquired a portfolio of 222 patents from Harris Corporation covering 15 years of research across many technologies.
Harris & Harris Group invests in transformative companies developing disruptive science and technology. It has a portfolio of 26 companies across various sectors including life sciences, electronics, and energy. Recent liquidity events from companies like Xradia that was acquired by Carl Zeiss have generated gains. The company aims to continue realizing value from its portfolio through partnerships and exits over the next few years to drive further growth.
This document provides an overview of Big North Graphite Corp., a mining company exploring opportunities in Mexico and Canada. It discusses Big North's management team and board of directors, capital structure, and key investment highlights. Specifically, it outlines Big North's plans to accelerate re-starting operations at the historic Nuevo San Pedro Graphite Mine in Mexico, which produced amorphous graphite in the past. Big North acquired three past-producing graphite mines in Mexico and is working to resume production at Nuevo San Pedro.
Oragenics is developing novel antibiotics and probiotics through synthetic biology collaborations. For antibiotics, they are focusing on lantibiotics, a class of naturally produced antibacterial peptides, to address the need for new antibiotics. Their lead compound MU1140 has shown efficacy against MRSA, VRE and C. difficile. For probiotics, they are engineering bacteria to deliver therapeutics locally in the oral cavity for diseases like canker sores and Behcet's disease. They also market the only patented probiotic for oral health called ProBiora3. Upcoming milestones include animal studies for MU1140 in 2014 and generating genetically modified probiotic prototypes in 2014-2015.
Genius Brands International provides children's entertainment content across multiple platforms. It owns established brands like Baby Genius that have found success in television, online, mobile, and consumer products. The company aims to produce content that is both entertaining and enriching for kids. It has an experienced management team with decades of experience in the children's entertainment industry. Genius Brands sees opportunities to expand its brands internationally and introduce new content partnerships with figures like Warren Buffett, Thomas Edison, and Stan Lee.
This document provides an overview of Galectin Therapeutics, a clinical stage biopharmaceutical company targeting fibrotic diseases and cancer. It summarizes the company's focus on developing galectin inhibitors, proteins that are important in fibrosis and cancer. Specifically, it outlines Galectin's development program for non-alcoholic steatohepatitis (NASH), a fatty liver disease, including preclinical evidence, current Phase 1 clinical trial testing safety and pharmacokinetics, and plans for a Phase 2 trial to evaluate efficacy in reducing liver fibrosis.
Opexa Therapeutics is developing Tcelna, a precision immunotherapy for the treatment of secondary progressive multiple sclerosis (SPMS). Tcelna consists of attenuated myelin-reactive T-cell clones that are designed to program the immune system to target pathogenic myelin-reactive T-cells. Opexa has an ongoing Phase IIb clinical trial of Tcelna in SPMS and expects to complete enrollment in mid-2014, with top-line data expected in mid-2016. Opexa has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments.
Opexa Therapeutics December 2015 Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their T-cell immunotherapy Tcelna is in Phase 2b clinical trials for secondary progressive multiple sclerosis. Preclinical studies of OPX-212 showed a reduction of AQP4 reactive T-cells in a murine model of neuromyelitis optica, an orphan disease with no approved therapies. Opexa secured funding to advance OPX-212 into a Phase I/II clinical trial in 2016 pending regulatory approval. Their proprietary ImmPath platform allows for personalized T-cell therapies tailored for individual patient's disease profiles.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead program, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis (SPMS). If successful, Tcelna has the potential to address an unmet medical need as there is currently only one approved drug for SPMS that is not suitable for chronic use due to side effects. Opexa has an agreement with Merck Serono to develop Tcelna for MS indications worldwide, excluding Japan. Topline results from the Phase 2b SPMS trial are expected in late 2016.
Opexa Therapeutics presented information on their Precision Immunotherapy platform and lead programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown promise in reducing reactive T-cells and relapse rates in prior studies. Their platform also supports development of OPX-212 for neuromyelitis optica, a rare disease with no approved therapies. Opexa has an option agreement with Merck Serono for Tcelna in MS and recently secured $5 million in funding to advance OPX-212 into clinical trials for NMO.
This document provides an overview and summary of Opexa Therapeutics' rights offering. Key points include:
- Opexa is conducting a rights offering of up to 28.8 million units to fund its ongoing Phase 2b trial of Tcelna in secondary progressive multiple sclerosis and a potential Phase 1/2 trial of OPX-212 in neuromyelitis optica.
- Proceeds will also be used for general corporate purposes.
- Tcelna utilizes Opexa's proprietary precision immunotherapy platform and has received Fast Track designation from the FDA for secondary progressive MS. Prior clinical trials in both relapsing-remitting and secondary progressive MS showed encouraging results.
- The rights offering is
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
Tcelna is a precision immunotherapy under development by Opexa Therapeutics for the treatment of multiple sclerosis (MS). Opexa is currently conducting a Phase IIb clinical trial of Tcelna in patients with secondary progressive MS (SPMS). Previous clinical trials of Tcelna in both relapsing-remitting and SPMS patients showed promising results, including a 37% reduction in annualized relapse rate in a Phase IIb RRMS trial. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in MS that could provide over $220 million in payments if milestones are achieved.
Dr. Patrick Soon-Shiong Presents at the 37th Annual J.P. Morgan Healthcare Co...DV4416
- The document is an investor presentation by Dr. Patrick Soon-Shiong for NantKwest discussing the company's immunotherapy strategies and product candidates.
- It outlines NantKwest's approach of harnessing the entire immune system through activating immune killer cells, blocking immune suppressor cells, and targeting tumor cells.
- The presentation highlights several of NantKwest's platform technologies and product candidates including activated NK cells, CIML NK cells, T memory stem cells, and their proprietary cell engineering and manufacturing capabilities.
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.
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.
CLBS Corporate Slide Presentation March 2018Steve Sizer
This corporate presentation discusses Caladrius Biosciences' business model evolution and future plans. It summarizes that Caladrius has transitioned to focus solely on clinical-stage therapeutics development using two technology platforms: autologous T-regulatory cells for immune modulation and CD34 cells for ischemic repair. Key programs outlined include an ongoing Phase 2 trial of T-regulatory cells for recent-onset type 1 diabetes and planned Phase 2 trials of CD34 cells for critical limb ischemia and coronary microvascular dysfunction. The presentation positions Caladrius for continued growth with a well-funded pipeline and strategic partnerships.
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.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
IntelGenx is an innovative pharmaceutical company focused on oral thin film drug delivery technologies. They have developed a proprietary oral thin film technology platform called VersaFilm that can be used to improve existing drugs or develop new products. Their pipeline includes several product candidates targeting large markets like migraines, erectile dysfunction, and brain degenerative diseases. They have state-of-the-art manufacturing facilities and strategic partnerships to commercialize their products globally.
Similar to Opexa therapeutics corporate presentation june 2014 for print (15)
Big North Graphite : Presenting at Global Online CEO Conference Small Stocks...RedChip Companies, Inc.
This document provides an overview of Big North Graphite Corp., a mining company exploring graphite opportunities in Mexico and Canada. It summarizes the management team's experience, the capital structure including shares outstanding and warrants, and key investment highlights. Specifically, it notes Big North is currently selling amorphous graphite in Mexico and aims to restart near-term flake graphite production at its recently acquired El Tejon Flake Graphite Mine and Mill in Oaxaca, Mexico, which was previously operational until 2002. A cautionary note also indicates forward-looking statements may materially differ from expectations.
“The Coin Tree is a cloud-based storage, insurance, and payment processing platform for bitcoin that leverages cutting edge transactional security to serve the ever expanding virtual currency community."
StarStream Entertainment is a theatrical motion picture production and financing company focused on producing and financing edgy, high quality motion pictures with strong cast and lean budgets for a commercial audience.
StarStream Entertainment is a theatrical motion picture production and financing company focused on producing and financing edgy, high quality motion pictures with strong cast and lean budgets for a commercial audience.
StarStream Entertainment aims to be a theatrical motion picture production and financing company focused on producing edgy, high quality films with strong casts and lean budgets. It mitigates risk through fiscal precision by financing projects once they are fully developed and ready to produce, offering investors a quicker return. Recent successful films include Lee Daniels' The Butler, Life of Crime, and Life After Beth.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
- Bitcoin Shop is one of the first publicly traded companies focused on the virtual currency ecosystem. It operates an ecommerce platform that accepts bitcoin and other cryptocurrencies as payment.
- The company is developing its BTCS 2.0 platform to expand its product offerings and vendor base. It aims to build a virtual currency ecosystem through ecommerce.
- Bitcoin Shop has a experienced management team with expertise in capital markets, technology, and the virtual currency industry. It plans to grow its customer base and monetize through additional service offerings.
InterCloud Systems provides cloud-centric solutions and services to enterprises and service providers. Their two main business focus areas are Software Defined Enterprise and Cloud to Cloud Mobility. They help customers modernize infrastructure, develop cloud strategies, and deliver cloud-centric IT visions aligned to business value. InterCloud partners with major cloud platform and solution providers like VMware, OpenStack, and CloudStack.
This presentation provides an overview of SANUWAVE Health Inc., a regenerative medicine company developing non-invasive biological response activation devices. SANUWAVE's lead product, dermaPACE, is in a Phase III FDA trial for treating diabetic foot ulcers and has the potential for approval in 2015 pending positive results. DermaPACE offers a lower-cost, non-invasive alternative to existing wound therapies. If approved, dermaPACE could address the large diabetic foot ulcer market and be expanded to other applications. SANUWAVE completed a $9.3 million capital raise to fund the dermaPACE trial and has 38 patents covering its shockwave technology platform.
StationDigital is a digital media and ecommerce platform that allows users to stream or access any media and purchase digital and physical goods from any device. It has grown rapidly since its public beta launch in 2013, achieving over 1.3 million mobile users. The presentation outlines StationDigital's mission and growth strategy, competitive advantages over other media companies, and large market opportunity in digital media and ecommerce. It argues that StationDigital is well positioned for continued growth and market share capture.
DRONE Aviation Corp (DRNE) was formed in April 2014 to penetrate the rapidly growing Unmanned Aerial Systems (UAS) business in U.S. and abroad for government and commercial customers.
DRNE’s mission is to aggressively penetrate the expanding Drone market with our unique Tethered Drones, which are currently being fielded to the U.S. Department of Defense and State and Local municipalities.
DRNE owns and operates Florida-based Lighter Than Air Systems Corp (LTAS), a developer and supplier of unique and specialized aerial solutions to the U.S. Government, State municipalities, and commercial entities.
InterCloud Systems Incorporated is a single - source provider of end - to - end IT technology and telecom solutions to the ent erprise, service provider, and g overnment markets through “Cloud Platforms” and professional services. “Cloud Comput ing”, is defined as the use of computing resources (compute, NTK, Storage) that are delivered as a managed service over a network. InterCloud offers its service provider custo mers the ability to utilize “cloud” solutions inside their existing network footp rint as well as in a “white label environment” so it can offer a suite of cloud products under their own brand, delivered over the broadband services it presently sell s . ICLD’s cloud services include infrastructure as a service (IaaS), platform as a servi ce (PaaS), and software as a service (SaaS) .
This document provides an overview of Actinium Pharmaceuticals, Inc. and summarizes their proprietary alpha particle immunotherapy technology and product pipeline. Key points include:
1) Actinium has a pipeline of targeted radiotherapy candidates using alpha emitters to treat various blood cancers. Their lead candidate, Iomab-B, is being developed for conditioning blood cancer patients prior to bone marrow transplant.
2) Iomab-B has shown promising results in clinical trials, successfully preparing older refractory AML patients for transplant who otherwise would not be eligible. Actinium has FDA agreement to advance Iomab-B into a Phase III registration trial.
3) Actinium has a proprietary technology
Richfield Oil & Gas Company (OTCQX: ROIL) is an independent exploration and production company headquartered in Salt Lake City, Utah. The Company’s current oil production flows from wells in fields located in Kansas and Wyoming. In addition to several thousand acres in Kansas, Richfield also owns strategically-located exploratory leases in central Utah on trend to major oil discoveries.
American Water provides water and wastewater services to approximately 14 million people in 16 states, has a market capitalization of $8.6 billion, and seeks to continue growing its regulated water business through capital investments and acquisitions while also expanding its complementary market-based business lines. The company has delivered strong total shareholder returns since its 2008 IPO and maintains a transparent dividend policy aimed at increasing its dividend in line with normalized earnings per share growth.
Exeo Entertainment, Inc. is a manufacturing company concentrating on developing innovative products that fill a clearly defined need in today’s interactive entertainment industry. Featured products include the Zaaz™ smart TV keyboards, Patented Psyko Krypton™ 5.1 gaming headphones, Krankz Bluetooth music headphones, an Android® based portable gaming system, and the Extreme Gamer® -the world’s first multi–disc game changer.
Direct Insite (“DIRI”) provides cloud-based, ERP-agnostic solutions that automate Accounts Payable (AP) and Accounts Receivable (AR) invoice processes for Global 3000 companies. Their solutions include invoice validation, order matching, consolidation, dispute handling and e-payment processing. DIRI helps clients eliminate manual processes and costs associated with doing everything on paper. By migrating from paper to electronic, DIRI can reduce transactions costs 50-70% and reduce time by 80%. Current clients include Siemens, HP, IBM, Saint-Gobain, Shell Oil, and Hyatt with a Global vendor network of 350,000+ suppliers.
Lattice Incorporated (“Lattice” or the “Company”), founded in 1973, provides secure communications and information technology, specializing in deploying advanced technology and services to create innovative, cost - effective solutions for the Company’s global customers. The Company provides both wholesale and direct services to correctional facilities and their service providers in the U.S., Canada and Europe. Expansion of Lattice’s direct and wholesale services, including increased techno logy equipment and software sales to wholesale customers, is expected to drive revenue growth and increased margins in the quarters ahead
Quadrant 4 Systems Corporation is a leading provider in of health exchange platforms, innovative software products and proprietary SMAC (social media, mobility, analytics and cloud computing) solutions to enterprise clients in Retail and Manufacturing, Media and Publishing, Financial Services and Health Care sectors.
This document provides a safe harbor statement and background information on VeriTeQ Corporation. It discusses forward-looking statements and risks associated with investment. It then provides an overview of the company, including its founding, acquisitions, regulatory clearances, and financing activities. Key areas of focus for the company are discussed, including medical device UDI/identification and biosensing/radiation dosimetry technologies. Leadership and intellectual property are also summarized.
Fit to Fly PCR Covid Testing at our Clinic Near YouNX Healthcare
A Fit-to-Fly PCR Test is a crucial service for travelers needing to meet the entry requirements of various countries or airlines. This test involves a polymerase chain reaction (PCR) test for COVID-19, which is considered the gold standard for detecting active infections. At our travel clinic in Leeds, we offer fast and reliable Fit to Fly PCR testing, providing you with an official certificate verifying your negative COVID-19 status. Our process is designed for convenience and accuracy, with quick turnaround times to ensure you receive your results and certificate in time for your departure. Trust our professional and experienced medical team to help you travel safely and compliantly, giving you peace of mind for your journey.www.nxhealthcare.co.uk
At Malayali Kerala Spa Ajman, Full Service includes individualized care for every client. We specifically design each massage session for the individual needs of the client. Our therapists are always willing to adjust the treatments based on the client's instruction and feedback. This guarantees that every client receives the treatment they expect.
By offering a variety of massage services, our Ajman Spa Massage Center can tackle physical, mental, and emotional illnesses. In addition, efficient identification of specific health conditions and designing treatment plans accordingly can significantly enhance the quality of massaging.
At Malayali Kerala Spa Ajman, we firmly believe that everyone should have the option to experience top-quality massage services regularly. To achieve that goal we offer cheap massage services in Ajman.
If you are interested in experiencing transformative massage treatment at Malayali Kerala Spa Ajman, you can use our Ajman Massage Center WhatsApp Number to schedule your next massage session.
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NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
Sectional dentures for microstomia patients.pptxSatvikaPrasad
Microstomia, characterized by an abnormally small oral aperture, presents significant challenges in prosthodontic treatment, including limited access for examination, difficulties in impression making, and challenges with prosthesis insertion and removal. To manage these issues, customized impression techniques using sectional trays and elastomeric materials are employed. Prostheses may be designed in segments or with flexible materials to facilitate handling. Minimally invasive procedures and the use of digital technologies can enhance patient comfort. Education and training for patients on prosthesis care and maintenance are crucial for compliance. Regular follow-up and a multidisciplinary approach, involving collaboration with other specialists, ensure comprehensive care and improved quality of life for microstomia patients.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
India Home Healthcare Market: Driving Forces and Disruptive Trends [2029]Kumar Satyam
According to the TechSci Research report titled "India Home Healthcare Market - By Region, Competition, Forecast and Opportunities, 2029," the India home healthcare market is anticipated to grow at an impressive rate during the forecast period. This growth can be attributed to several factors, including the rising demand for managing health issues such as chronic diseases, post-operative care, elderly care, palliative care, and mental health. The growing preference for personalized healthcare among people is also a significant driver. Additionally, rapid advancements in science and technology, increasing healthcare costs, changes in food laws affecting label and product claims, a burgeoning aging population, and a rising interest in attaining wellness through diet are expected to escalate the growth of the India home healthcare market in the coming years.
Browse over XX market data Figures spread through 70 Pages and an in-depth TOC on "India Home Healthcare Market”
https://www.techsciresearch.com/report/india-home-healthcare-market/15508.html
nursing management of patient with Empyema pptblessyjannu21
prepared by Prof. BLESSY THOMAS, SPN
Empyema is a disease of respiratory system It is defines as the accumulation of thick, purulent fluid within the pleural space, often with fibrin development.
Empyema is also called pyothorax or purulent pleuritis.
It’s a condition in which pus gathers in the area between the lungs and the inner surface of the chest wall. This area is known as the pleural space.
Pus is a fluid that’s filled with immune cells, dead cells, and bacteria.
Pus in the pleural space can’t be coughed out. Instead, it needs to be drained by a needle or surgery.
Empyema usually develops after pneumonia, which is an infection of the lung tissue. it is mainly caused due in infectious micro-organisms. It can be treated with medications and other measures.
Solution manual for managerial accounting 18th edition by ray garrison eric n...rightmanforbloodline
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Enhancing Hip and Knee Arthroplasty Precision with Preoperative CT and MRI Im...Pristyn Care Reviews
Precision becomes a byword, most especially in such procedures as hip and knee arthroplasty. The success of these surgeries is not just dependent on the skill and experience of the surgeons but is extremely dependent on preoperative planning. Recognizing this important need, Pristyn Care commits itself to the integration of advanced imaging technologies like CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) into the surgical planning process.
India Medical Devices Market: Size, Share, and In-Depth Competitive Analysis ...Kumar Satyam
According to TechSci Research report, “India Medical Devices Market Industry Size, Share, Trends, Competition, Opportunity and Forecast, 2019-2029,” the India Medical Devices Market was valued at USD 15.35 billion in 2023 and is anticipated to witness impressive growth in the forecast period, with a Compound Annual Growth Rate (CAGR) of 5.35% through 2029. This growth is driven by various factors, including strategic collaborations and partnerships among leading companies, a growing population, and the increasing demand for advanced healthcare solutions.
Recent Trends
Strategic Collaborations and Partnerships
One of the most significant trends driving the India Medical Devices Market is the increasing number of collaborations and partnerships among leading companies. These alliances aim to merge the expertise of individual companies to strengthen their market position and enhance their product offerings. For instance, partnerships between local manufacturers and international companies bring advanced technologies and manufacturing techniques to the Indian market, fostering innovation and improving product quality.
Browse over XX market data Figures and spread through XX Pages and an in-depth TOC on " India Medical Devices Market.” - https://www.techsciresearch.com/report/india-medical-devices-market/8161.html
Emotional and Behavioural Problems in Children - Counselling and Family Thera...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Health Tech Market Intelligence Prelim Questions -Gokul Rangarajan
The Ultimate Guide to Setting up Market Research in Health Tech part -1
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
This lays foundation of scoping research project what are the
Before embarking on a research project, especially one aimed at scoping and defining parameters like the one described for health tech IT, several crucial considerations should be addressed. Here’s a comprehensive guide covering key aspects to ensure a well-structured and successful research initiative:
1. Define Research Objectives and Scope
Clear Objectives: Define specific goals such as understanding market needs, identifying new opportunities, assessing risks, or refining pricing strategies.
Scope Definition: Clearly outline the boundaries of the research in terms of geographical focus, target demographics (e.g., age, socio-economic status), and industry sectors (e.g., healthcare IT).
3. Review Existing Literature and Resources
Literature Review: Conduct a thorough review of existing research, market reports, and relevant literature to build foundational knowledge.
Gap Analysis: Identify gaps in existing knowledge or areas where further exploration is needed.
4. Select Research Methodology and Tools
Methodological Approach: Choose appropriate research methods such as surveys, interviews, focus groups, or data analytics.
Tools and Resources: Select tools like Google Forms for surveys, analytics platforms (e.g., SimilarWeb, Statista), and expert consultations.
5. Ethical Considerations and Compliance
Ethical Approval: Ensure compliance with ethical guidelines for research involving human subjects.
Data Privacy: Implement measures to protect participant confidentiality and adhere to data protection regulations (e.g., GDPR, HIPAA).
6. Budget and Resource Allocation
Resource Planning: Allocate resources including time, budget, and personnel required for each phase of the research.
Contingency Planning: Anticipate and plan for unforeseen challenges or adjustments to the research plan.
7. Develop Research Instruments
Survey Design: Create well-structured surveys using tools like Google Forms to gather quantitative data.
Interview and Focus Group Guides: Prepare detailed scripts and discussion points for qualitative data collection.
8. Sampling Strategy
Sampling Design: Define the sampling frame, size, and method (e.g., random sampling, stratified sampling) to ensure representation of target demographics.
Participant Recruitment: Plan recruitment strategies to reach and engage the intended participant groups effectively.
9. Data Collection and Analysis Plan
Data Collection: Implement methods for data gathering, ensuring consistency and validity.
Analysis Techniques: Decide on analytical approaches (e.g., statistical
Digital Health in India_Health Informatics Trained Manpower _DrDevTaneja_15.0...DrDevTaneja1
Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
Presently, generalist IT manpower does most of the work in the healthcare industry in India. Academic Health Informatics education is not readily available at school & health university level or IT education institutions in India.
We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
2. 2
Forward-Looking Statements
• This investor presentation contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements contained in this
presentation, other than statements of historical fact, constitute “forward-looking statements.” The words “expects,” “believes,”
“anticipates,” “estimates,” “may,” “could,” “intends,” and similar expressions are intended to identify forward-looking statements.
Forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that statements which are not
strictly historical statements, including, without limitation, statements regarding the development of our product candidate, Tcelna
(imilecleucel-T), constitute forward-looking statements.
• Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially
from those anticipated. These risks and uncertainties include, but are not limited to, risks associated with: market conditions; our capital
position; our ability to compete with larger, better financed pharmaceutical and biotechnology companies; new approaches to the
treatment of our targeted diseases; our expectation of incurring continued losses; our uncertainty of developing a marketable product;
our ability to raise additional capital to continue our development programs (including to undertake and complete any ongoing or further
clinical studies for Tcelna); our ability to satisfy various conditions required to access the financing potentially available under the
purchase agreements with Lincoln Park Capital Fund, LLC (“Lincoln Park”) or sell shares of our common stock to Lincoln Park or under
our at-the-market (ATM) facility; our ability to maintain compliance with NASDAQ listing standards; the success of our clinical trials
(including the Phase IIb trial for Tcelna in Secondary Progressive Multiple Sclerosis which, depending upon results, may determine
whether Ares Trading SA (“Merck”) elects to exercise its option for an exclusive license to Tcelna for the treatment of multiple sclerosis
(the “Option”)); whether Merck exercises the Option and, if so, whether we receive any development or commercialization milestone
payments or royalties from Merck pursuant to the Option; our dependence (if Merck exercises the Option) on the resources and abilities
of Merck for the further development of Tcelna; the efficacy of Tcelna for any particular indication; our ability to develop and
commercialize products; our ability to obtain required regulatory approvals; our compliance with all FDA regulations; our ability to
obtain, maintain and protect intellectual property rights; the risk of litigation regarding our intellectual property rights or the rights of
third parties; the success of third party development and commercialization efforts with respect to products covered by intellectual
property rights that we may license or transfer; our limited manufacturing capabilities; our dependence on third-party manufacturers;
our ability to hire and retain skilled personnel; our volatile stock price; and other risks detailed in our filings with the SEC.
• These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-
looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on
which any such statement is based. You should, however, review additional disclosures we make in our Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the SEC.
3. 3
Introduction to Opexa
• Antigen specific T-cell immunotherapy platform
– Potential to address multiple therapeutic areas
– Lower capital intensity by leveraging existing GMP manufacturing
– Strong Patent Estate: 50 patents issued on T-cell platform (domestic and
international)
• Lead Program: Tcelna®, in development for Multiple Sclerosis
– Phase IIb clinical trial in Secondary Progressive MS (SPMS)
– Limited treatment options currently available for SPMS
– Potential SPMS market in North America alone could exceed $7 Billion
– Fast Track designation from the U. S. Food and Drug Administration (FDA)
for the treatment of SPMS
– Option Agreement with Merck Serono, a strong potential commercial partner
4. 4
Progress Update
• Clinical
– As of May 13, 2014, Opexa has randomized 180 patients or 100% of the
targeted total number of patients in the Abili-T study in SPMS
– Patients in the screening process at time of full enrollment will be allowed
to enroll if they meet trial enrollment criteria
– Top line data expected in mid-2016
• Financial
– As of March 31, 2014, Opexa had $19.7 million in cash and cash
equivalents
– Projected liquidity into Q4 2015, based on current operations and clinical
activities
• Management
– Recent addition of Tim Barabe and Dr. Hans-Peter Hartung to Opexa’s
Board of Directors
5. 5
Tcelna in Secondary Progressive MS
SPMS
450,000 Individuals in North America diagnosed with MS;
30-45 % potentially have an SPMS diagnosis
Market Size:
$7 Billion (est.)
RRMS, CIS, PPMS
• Potential SPMS market in North
America alone could exceed $7 billion
• Roughly 150,000 SPMS patients in
North America
• Only one drug approved for SPMS in
U.S. (none in EU or Asia)
- Drug not suitable for chronic use
due to severe side effects
Tcelna being developed to be a
potential therapy of choice in SPMS
6. 6
The Root Cause of Multiple Sclerosis: Activated T- cells
Degrade Myelin and Damage Myelin Producing Cells
Adapted by permission from Macmillan Publishers Ltd: NATURE REVIEWS
IMMUNOLOGY 3, 483-492 (June 2003), copyright (2003)
Cytokines
Damage
Damage
• In MS patients, the faulty immune system is
not able to prevent the attack of a small sub-
population of myelin reactive T-cells (MRTC)
• Myelin Reactive T-cells (MRTC) cross the
blood brain barrier, enter the brain, and bind
to antigen presenting cells (APC), causing a
release of pro-inflammatory cytokines which
lead to a two pronged attack through:
1. Destruction of myelin sheath, the protective
coating of nerve fibers
2. Destruction of oligodendroglial cells, which
are responsible for producing myelin
Result Destruction of the myelin sheath and
myelin producing cells, thereby preventing
remyelination
Myelin peptide
7. 7
Tcelna®
Consists of Attenuated Antigen
Specific T-cell Clones
• Therapeutic dose of Tcelna
(attenuated T-cell clones) is injected
subcutaneously
• Immune system recognizes the large
volume of cells (30-45 million) under
the skin as potential foreign pathogens
• We believe Tcelna triggers an immune
response specifically targeting
circulating MRTC
• The irradiation of Tcelna prior to
injection causes the injected cells to
eventually die off, but only after they
have primed the immune response
Tcelna: attenuated antigen specific T-cells
Tcelna®
8. 8
Tcelna Could Address the Root Cause of Multiple Sclerosis by
Preventing Demyelination and Enabling Remyelination
Adapted by permission from Macmillan Publishers Ltd: NATURE REVIEWS
IMMUNOLOGY 3, 483-492 (June 2003), copyright (2003)
Opexa’s Strategy
Tcelna programs the immune system to
specifically recognize MRTC as pathogenic,
thereby inhibiting further destruction of the
myelin sheath and potentially enabling
remyelination
• Immune cells, including Tregs, have been
primed, or sensitized, we believe, to
specifically target the pathogenic MRTC for
elimination or regulation
• Elimination of harmful MRTC may lead to:
o Stabilization of disease by preventing
further destruction of myelin
o Improvement in condition by allowing
Oligondendroglial cells to remyelinate
axons (neuroprotection)
9. 9
Mechanism of Action
Reduction in Myelin Reactive T-Cells
-100%
-90%
-80%
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
Week 0 Week 5 Week 13 Week 21 Week 28 Week 52
Results from Tcelna dose ranging
studies: Published in Clinical
Immunology (2009) 131, 202-215
ReductioninMRTC
Dose 2 Dose 3 Dose 4
Each dose consisting of 30-45 x 106 cells
Dose 1
Tcelna Demonstrated a Reduction in Myelin Reactive T-cells (MRTC)
10. 10
Single Cycle Manufacturing Process:
Annual course of treatment (5 doses) from one blood draw
Cryopreservation
Formulation/
Irradiation of each
dose as required
Administration: 5
subcutaneous
injections/year
Manufacturing and QC Dispensation
35 days
Epitope Profiling
1 day14 days
- Red Cross
- Blood Group Alliance
Epitope Profiling Expansion of antigen specific T-cells
11. 11
Merck Serono Agreement for MS indication
• February 2013 option and license agreement with Merck Serono
– Up to $220 million in additional payments
• Option exercise $25 million for starting Phase III/ or $15 million if another Phase II
• $35 million FDA filing, approval and commercialized in US
• $30 million for EU filing, approval and commercialization in at least three countries
• Relapsing Remitting MS development and commercialization of up to $40 million
– One time commercial milestones of up to $85 million
• Royalties ranging from 8% to 15% of annual net sales with step-ups
occurring when net sales exceed $500 million, $1 B & $2 B
• Opexa maintains key rights:
– Development and commercialization rights to Tcelna in Japan
– Certain manufacturing rights
– Co-development funding option in exchange for increased royalties
– Rights to all other disease indications
12. 12
Tcelna Development Program
Broad Spectrum of MS patients treated
Phase
Completion
Dates
Population
Total
N
Treatment
Duration
(months)
Tcelna Placebo
Baylor 1998
RRMS, PPMS,
SPMS (26)
114
Up to 24
months
114
Phase I dose
escalation
2006
RRMS (5)
SPMS (6)
16 12 16 -
Phase I/II
Open label
retreatment
2007
RRMS (9)
SPMS (4) 13 12 13 -
Phase IIb
TERMS
2008 RRMS, CIS 150 12 100 50
Phase IIb
extension
OLTERMS
2008 RRMS, CIS 38
At least one
dose post
TERMS
15 from
placebo
arm
Phase IIb
Abili-T
Mid 2016* SPMS 180* 24* 90* 90*
* Expected upon completion of ongoing SPMS Abili-T trial
13. 13
TERMS Study - Prospective Analysis in
More Active or Progressive Patients
Sub-population of patients (n=50) with more progressed/active disease
profile (baseline ARR >1)
2.4
2.23
2.2
2.39
2.1
2.15
2.2
2.25
2.3
2.35
2.4
2.45EDSSScore(Mean)
Baseline Week 52
Tcelna
Placebo
(p=0.045)
0.28
0.63
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
ARR
(relapses/patient/yr)
Tcelna
Placebo
55%
n=32 n=18
-0.04
-0.32
-0.35
-0.3
-0.25
-0.2
-0.15
-0.1
-0.05
0
Brainvolumechange
(%)
Tcelna
Placebo88%
n=32 n=18
88% Reduction in
Brain Atrophy
Percent Brain Volume Change
at Week 52
Statistically Significant
Improvement in Disability (p=0.045)
55% Reduction in ARR
Annualized Relapse Rate (ARR)
at Week 52
Change in Disability (EDSS)
at Week 52
These Data Support Phase IIb Program in SPMS
14. 14
Tcelna Stabilizes Disease in SPMS at 2 Years
80%
20%
40%
0%
20%
40%
60%
80%
100%
PercentofPatientsShowing
DiseaseStabilization
Stabilization vs. Historical Progression
Stable
Progressed
80% of subjects treated with Tcelna showed no
further disease progression by EDSS at 2 years
Historical Disease
Progression
Tcelna Open Label
(n=35)
*A small percentage of patients in pooled analysis showed an
improvement (i.e. decrease in progression)
**Historical control: ESIMS Study,
published Hommes Lancet 2004
15. 15
Abili-T : Phase IIb Clinical Trial
Enrollment Target Reached
• FDA Fast Track Designation
• Secondary Progressive MS patients only
• Status
– Enrolment target reached: 180 patients
• Patients currently in screening process still eligible to enroll
• Design
– Double-blind, 1:1 randomized, placebo-controlled
– Trial fully enrolled at 180 patients
– Approximately 35 clinical sites in USA and Canada
– Two annual courses of personalized therapy
• Timing
− Top-line data expected mid-2016
16. 16
Efficacy Assessments
• Primary Endpoint
– Whole-brain atrophy
• Secondary Endpoints
– Sustained progression measured by EDSS
– Time to sustained progression
– T2 lesions progressing to hypointense lesions (black holes)
– Change in EDSS
– Annualized Relapse Rate (ARR)
– Change in MSFC Assessment of disability
– Change in Symbol Digit Modality Test (SDMT)
• Exploratory Endpoints
– Quality of life assessment by MSQLI
– Gd-enhancing lesion volume with increasing MTR
– Gd-enhancing lesion volume with decreasing MTR
– Change in MTR in normal-appearing white matter
– Changes in T-regulatory cell repertoire and function
17. 17
Immune Monitoring Program
Phenotypical Analysis
(CD4 and CD8)
Pro-inflammatory Anti-inflammatory
TH1 Treg
TH17 Tr1
TH2
IL-2 IL-4
IL-6 IL-5
IL-12 IL-10
IL-17E, IL-17F
IL-23 IL-27
TNFα TGFβ
IFNϒ BDNF
Plausible indicators of
Tcelna efficacy
• Reduction in Th1/TH17
• Increase in Treg/Tr1 cells
• Reduction in proinflammatory
cytokines (IL-12, IL-23, IFNϒ,
TNFα)
• Increase in anti-inflammatory
cytokines (IL-10, IL-27)
• Loss of proinflammatory
monocyte markers (CD16/HLA-
DR, CCR5)
• Gain in anti-inflammatory
monocyte markers (PDL-1, HLA-
G, ICOS)
2013 2014 20152012
Trial initiation
Immuno vigilance
Whole blood analysis:
Absolute frequency of
T-cells, B-cells, Dendritic
cells and Monocytes
• Goal is to show no systemic
impact on immune
response, i.e. Tcelna is a
Precision Immunotherapy
• Tcelna differentiates by not
depleting a broad spectrum
of T-cells
90 patients at dose 5 180 patients at 10 doses40 patients at dose 5
2016
End of Study
18. 18
Financials
Cash and Cash Equivalents (MM) as of March 31, 2014 $19.7
Shares outstanding (MM) as of March 31, 2014 ~27.7
Warrants (MM) (1) ~3.1
Stock Options (MM) (2) ~2.5
(1) Weighted average exercise price =$4.12 as of March 31, 2014
(2) Weighted average exercise price = $2.96 as of March 31, 2014
19. 19
Experienced Management Team and Board of Directors
Neil Warma, President & CEO, Director
› 19+ years international healthcare experience with large Pharma and emerging
biotechnology companies
› Former Senior Management, Novartis Pharmaceuticals, Basel, Switzerland
› Former CEO, Viron Therapeutics, Inc.
› Co-founder and President of MedExact Inc., a company subsequently acquired
Karthik Radhakrishnan, Chief Financial Officer
› 10+ years of health care capital markets experience
› Formerly, Vice President at ING Investment Management
› MBA, MS in Engineering, CFA charter holder
Don Healey, Ph.D., Chief Scientific Officer
› 25+ years of experience in cellular immunology and immune regulation
› Former Director of Immunology, Argos Therapeutics
Donna Rill, Chief Development Officer
› 30 years in cell and gene therapy research and clinical application
› Designed and validated cGMP Cell & Gene Therapy Laboratories, Vector
Production facilities, and Translational Research Labs
Kenny Frazier, VP of Clinical Dev. and Regulatory
Affairs
› 24 years of extensive clinical and regulatory experience
› Formerly, Head of Clinical Operations, Lexicon Pharmaceuticals and Tanox,
Inc.
Board of Directors
Timothy Barabe
Board member of Arqule, Inc.; Former
CFO of Affymetrix, Human Genome
Sciences, Inc., Regent Medical UK and
Sandoz GmbH
Dr. Hans-Peter Hartung
Chair of Neurology at Heinrich-Heine
University, Germany; Executive Board
member of ECTRIMS
Gail J. Maderis
CEO, BayBio, Former CEO of Five
Prime Therapeutics, Founder of
Genzyme Molecular Oncology
Michael S. Richman
CEO, Amplimmune
Scott B. Seaman
Executive Director,
Alkek Foundation
Neil K. Warma
President & CEO, Opexa
20. 20
SPMS Scientific Advisory Board
Dawn McGuire, M.D., FAAN (Chair)
• Advisory Council of the Gill Heart Institute
• Former Vice President of Clinical Research at Elan Pharmaceuticals
Hans-Peter Hartung, M.D
• Chair of Neurology at Heinrich-Heine University, Düsseldorf
• Executive Board member of ECTRIMS, World Health Organization Advisory Board on MS
Mark S. Freedman, M.D.
• Director of the Multiple Sclerosis Research Unit at Ottawa Hospital
• Multiple Sclerosis Society of Canada, National MS Society (USA)
• ACTRIMS committee member
Clyde Markowitz, M.D.
• Director of MS Center at the University of Pennsylvania
Doug Arnold, M.D.
• James McGill Professor Neurology and Neurosurgery at the Montreal Neurological Institute
Edward Fox, M.D., Ph.D.
• Director of Multiple Sclerosis Clinic of Central Texas
• Advisory Committee, Lone Star Chapter of the National Multiple Sclerosis Society
21. 21
Investment Thesis
• T-cell platform company with Fast Track designation in SPMS
• Strong Intellectual property with 50 issued patents (domestic and
international)
• Esteemed Scientific Advisory Board
• Precision Immunotherapy potentially optimizes benefit-risk profile
• Targeting an unmet medical need in a potentially substantial market
• Option Agreement with Merck Serono, a strong potential
commercial partner
• Replacement value of company is multiples of present market cap
• Attractive potential risk-reward profile for long term/value investors
• Goal-oriented management team focused on value creation
23. 23
Tcelna® Highlights
• Clinical studies conducted in Relapsing Remitting and Secondary Progressive MS
• Progress made on manufacturing with focus on commercially viable process
─ Over 850 Tcelna preparations have been successfully manufactured, reproducible and
consistent
• Safety demonstrated and trends in clinical efficacy across broad spectrum of patients
for Relapsing Remitting and Secondary Progressive MS
• Dose and regimen for ongoing clinical development has been selected based on dose
ranging studies
• Commercial opportunities in MS:
– Secondary Progressive MS
• Abili-T Phase II SPMS trial ongoing with 180 patients expected in U.S. and Canada
• Fast track designation
– Relapsing Remitting MS
• Formal End of Phase II meetings have been conducted
• FDA feedback obtained for potential Phase III studies
24. 24
Tcelna Manufacturing:
Personalization followed by Expansion Step
The Epitope Profiling Assay (EPA)
• Screen peripheral blood for Myelin-Reactive T-cells (MRTCs), and
mapping of immunodominant epitopes to MBP, MOG and PLP
– 109 overlapping peptides encompassing MBP, MOG and PLP
– Interferon gamma response to individual peptide pools defines positive response
in 7 day assay
ImmPathTM Process
• Procure unit of blood from which up to six T-cell lines reactive with
immunodominant myelin peptides are generated and pooled as a
patient-specific Tcelna product
– Manufacturing performed under GMP/GTPs in functionally closed system
– Process generates a year of Tcelna doses from a single unit of blood
25. 25
Year 2
Year 3
Tcelna Manufacturing: Precision Medicine
Proprietary Assay Enables Annual Personalized Treatments
Year 1
Conduct analysis of 109 peptides from all three key myelin proteins (MBP, MOG, PLP)
• Re-assess epitope profile annually
to identify epitope shift
• Develop newly personalized
formulation annually based on
evolved epitope profile
26. 26
• Completed Phase IIb clinical trial in 150 RRMS patients; 33 sites in U.S.
• mITT population (n=142)
• 37% reduction in ARR vs. placebo
• ARR 0.214 vs. 0.339
• Superior safety and promising
efficacy trend demonstrated
• Two End-of-Phase II meetings
with FDA successfully completed
0.214
0.339
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
Relapses/patient/year
n=94 n=48
Tcelna
Placebo
TERMS Study
A Completed Phase IIb Clinical Trial in RRMS
37%
27. 27
Safety Summary
Deaths • No deaths occurred
Serious Adverse Events (SAEs) • No treatment-related SAEs
Most common adverse events • Mild to moderate injection site reaction
TERMS Study: Safety Overview
28. 28
TERMS Study - Subgroup Analysis
in Patients Naïve to DMT
Annualized relapse rate in DMT naïve populations. ARR in placebo subjects without previous disease modifying
treatment (DMT) experience reflects relapse rates commonly seen in other placebo controlled trials in MS. In this
subpopulation, treatment with Tcelna resulted in a 56–73% reduction in ARR compared with placebo.
0.21 0.18
0.31
0.48
0.5
1.18
0
0.2
0.4
0.6
0.8
1
1.2
1.4
mITT ARR > 1 ARR>1
AnnualizedRelapseRate(ARR)
Tcelna
Placebo
64% Reduction
p=0.046
73% Reduction
p=0.009
56% Reduction
p=0.060
n=25n=45 n=8n=16n=28n=53
29. 29
• 36 SPMS patients treated in three clinical studies
– 35 of these patients were treated with Tcelna for two years
– 26 patients treated at Baylor; 10 patients treated by Opexa
• Promising efficacy observed
– Disease stabilization as measured by EDSS was observed in 80% of patients at two years
(compared to a historical control data that shows progression rate of 40%)
– 10 patients in Opexa sponsored study showed significant reduction in relapse rates from a
baseline ARR of 0.5 to an ARR of 0.1 at two years
– No worsening in key Quality of Life Indicators (physical and psychological condition) at two years
• Well-tolerated with a favorable safety profile
– No Serious Adverse Events
Secondary Progressive MS:
Overview of Phase I/II Patients treated with Tcelna
30. 30
Tcelna Reduces Annualized Relapse Rate
(ARR) in SPMS at 2 yearsAnnualizedRelapseRate(ARR)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
Baseline 12 Months 24 Months
In 21.8 years of cumulative
patient follow up, only 1
patient experienced 1 relapse
One relapse observed in 21 years of cumulative patient follow up
Tcelna treated SPMS
patients (n=10)
31. 31
Tcelna Stabilizes Quality of Life Scores
in SPMS at 2 years
0.9%
1.2%
2.1%
-5.1%
-6.0%
-4.0%
-2.0%
0.0%
2.0%
4.0%
Physical
Psychological12 Month 18-24 Month
Negative percent change indicates
improvement from baseline
Following two years of treatment, no worsening of physical
condition and improvement in psychological condition
PercentageChangeinMultipleSclerosisImpactScale
Tcelna treated
(n=7)
Tcelna treated
(n=10)
32. 32
Efficacy Assessments
EDSS: Expanded Disability Status Scale
NEURO: Neurological Examination
SDMT: Symbol Digit Modalities Test
MSFC: MS Functional Composite
MSQLI: MS Quality of Life Indicator
MRI: Magnetic Resonance Imaging
T
500 mL
Procurement
Immune
Monitoring
Tcelna dose
Abili-T Annual Treatment and Efficacy
Assessment Schedule
32
E P
Epitope
Profile Assay
Baseline Wk 4 Wk 8 Wk 12 Wk 24 Wk 36ScreenScreen
T1 T3 T4 T5
EDSS
Neuro
EDSS
Neuro
SDMT
MSFC
MSQLI
EDSS
Neuro
SDMT
EDSS
Neuro
SDMT
EDSS
Neuro
SDMT
MSFC
MRI
Wk 52
EDSS
Neuro
SDMT
MSFC
MSQLI
MRI
IM1 IM3
MRI
IM2E P
IM
T2
IM4
33. 33
Mechanism of Action
• Attenuated, patient-specific (autologous) myelin reactive T-
cells (MRTC)
– MRTC expanded ex vivo in response to immunodominant peptides of MBP, MOG
and PLP
• Therapeutic sc dosing (30-45 x 106 cells) stimulates host
reactivity to the ‘over-represented’ MRTC inducing a
dominant negative ‘regulatory T-cell’ response leading to:
– Down-regulation of similar endogenous disease-causing myelin reactive T-cells
– Potential to induce up-regulation of regulatory cells (Foxp3+ and Tr1 cells) to
reduce inflammation and provide possible neuroprotection, should these gain
entry to the CNS
• Phase I/II studies conducted with Tcelna in RRMS and
SPMS showed a substantial reduction in MRTC, and
improved clinical outcomes
– lower relapse rates and stabilization of disease as defined by EDSS
34. 34
Mechanism of Action
Tcelna increases Tr1 cells in SPMS Patients
Clinical findings in Tcelna treated patients
• All three patients (who had experienced relapse in preceding 12-24 month) remained relapse
free during the 52-week assessment
• Showed stabilization of disease progression
• Showed a 57%-67% reduction in myelin reactive T-cell counts from baseline
Observations
• Increase in Tr1 cells from non-detectable to detectable levels in Tcelna treated patients (n=3)
• Increase in Tr1 cells to a level similar to those observed in healthy controls (n=4)
• p=0.971 (i.e. no statistical difference between healthy donor and post-treatment TR1 dose levels)
Pre-Tcelna (non-detectable)
Post -Tcelna
35. 35
Mechanism of Action
The Immunopathology of SPMS
• SPMS is associated with compartmentalized CNS
inflammatory cells
- Microglia activation suggests ongoing chronic innate immune responses
• SPMS is associated with inflammatory processes localized
within the central nervous system
- Mechanisms responsible for continued neurodegeneration in SPMS are distinct
from those of RRMS
- In SPMS, it is believed that the Blood Brain Barrier (BBB) remains closed enabling
only those products that are able to cross the BBB to be potentially effective
- SPMS is characterized by a chronic inflammatory process (vs. acute episodes for
RRMS)
• Immunological defects associated with progression to SPMS
- Levels of the anti-inflammatory cytokine IL-10 are reduced in patients with SPMS
- A therapeutic that has the potential to restore local production of IL-10 would be
expected to alleviate chronic inflammation, and thereby reduce neurodegeneration
36. 36
Baseline Abili-T patients versus Healthy
Individuals
CD4+ TR1:
CD4+CD45RA-LAG3+CD49b+
%ofCD4+Tcells
0
1
2
3
4
**
** (p=0.01)
Healthy
Donors
SPMS
Patients
SPMS subjects have a reduced frequency of IL-10 secreting TR1 cells
ACTRIMS 2013 Poster: Profiling of Secondary Progressive MS by Multicolor Flow Cytometry
Lauren W Collison, Ph.D; Chris L Ayers, Ph.D., Jordan L Harrell, MBE; Don Healey, Ph.D.
CD4+ TR1:
CD4+CD18bright
CD49b+
%ofCD4+Tcells
0
5
10
15
*
* (p=0.02)
Healthy
Donors
SPMS
Patients
37. 37
SPMS subjects have reduced nTReg cells
(another type of CD4 cells)
Foxp3+ nTregs:
CD4+CD127-CD25bright
Foxp3+
%ofCD4+Tcells
0.0
0.2
0.4
0.6
0.8
1.0
*
* (p=0.06)
Healthy
Donors
SPMS
Patients
Foxp3+ nTregs:
CD4+CD127-CD25bright
Foxp3+
MFI 0
5000
10000
15000
20000
25000
(p= 0.56)
Healthy
Donors
SPMS
Patients
(p=0.56)
Frequency of nTregs may be reduced in SPMS, although the level of Foxp3 expression is
equivalent to that of healthy donors. Therefore, function of Tregs cells is equivalent
between the populations, unlike in RRMS where reduction in Tregs may play a greater role
in the persistence of autoimmunity.
ACTRIMS 2013 Poster: Profiling of Secondary Progressive MS by Multicolor Flow Cytometry
Lauren W Collison, Ph.D; Chris L Ayers, Ph.D., Jordan L Harrell, MBE; Don Healey, Ph.D.
38. 38
SPMS patients have fewer Anti-inflammatory
monocytes (PDL1 and HLA-G)
PD-L1+ Monocytes:
CD14+CD16-ICOS+PD-L1+
%ofConvMonocytes
0
2
4
6
**
** (p=0.004)
Healthy
Donors
SPMS
Patients
HLA-G+ Monocytes:
CD14+CD16-ICOS+HLA-G+
%ofConvMonocytes
0.0
0.5
1.0
1.5
2.0
(p=0.164)
Healthy
Donors
SPMS
Patients
ACTRIMS 2013 Poster: Profiling of Secondary Progressive MS by Multicolor Flow Cytometry
Lauren W Collison, Ph.D; Chris L Ayers, Ph.D., Jordan L Harrell, MBE; Don Healey, Ph.D.