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  • Imugene: Research Shows Her-Vaxx Tumour Inhibition Promise

    Imugene Limited's (ASX:IMU) research has demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche's Herceptin drug in tumour model.

    In empirical work, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Herceptin, which also targets the HER-2/neu oncogene.

    It also demonstrated identical inhibition at one third dose compared with Herceptin.

    While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

    "With improvements to the formulation of HER-Vaxx, and empirical-based optimism that HER-Vaxx appears superior to Herceptin, we are rapidly finalising plans to trial our novel HER-Vaxx immunotherapeutic vaccine in patients with gastric cancer later this year," managing director Charles Walker said.

    "We are developing HER-Vaxx to generate a fast and strong stimulation of patients' immune systems to produce natural antibodies superior to Herceptin."

    The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

    Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

    This trial will improve understand of HER-Vaxx's functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients' immune systems

    Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.

    HER-Vaxx Pre-Clinical Research

    The research was conducted by a team at the Medical University of Vienna under the direction of Professor Dr Ursula Wiedermann.

    Human breast cancer cell line SK-BR-3 overexpressing HER-2/neu was incubated with increasing concentrations of purified HER-Vaxx antibody or with Trastuzamab (Herceptin).

    Her-Vaxx inhibited the proliferation of SK-BR-3 cells expressing high levels of HER-2/neu by 39% for 18.75ug dose, 58% for a 37.5ug dose and 66% for a 75ug dose.

    This compared to a 39% inhibition by Trastuzamab at a 50ug dose.

    The results indicate that Her-Vaxx is able inhibit the cancer cell growth with a dose of less than half that required for Herceptin while the higher dose is able to generate a response 70% greater.

    Enhanced Formulation

    In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

    Manufacturing has also been simplified with increased reliability and lower cost.

    Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.

    Upcoming Clinical Trial

    The upcoming Phase 1b/2 trial is designed to yield as much data and information as possible to guide the company and potential partners to develop HER-Vaxx into a commercial pharmaceutical as quickly and as efficiently as possible.

    Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be "open label", allowing data from the trial to be reported as it is conducted.

    Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

    This trial will improve understanding HER-Vaxx's functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients' immune systems.

    Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.

    This study will be a key inflection point underpinned by many years of research.

    Once the study begins, the company will increase business development work and meet with prospective partners to inform them of our progress, our innovative technology and trial design.

    With the depreciation in the Australian dollar and incentives in Australia, Imugene plans to conduct the trial in as many Australian hospitals as possible without compromising speed or efficiency.

    This will be better value for money, trial management will be more efficient and will likely benefit Australian trial participants with gastric cancer.

    Analysis

    The empirical data demonstrating that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin is promising.

    Shares in the company should trade higher on the news.

    It also ensures the upcoming Phase 1b/2 clinical trial, which could provide a clinical demonstration of this efficacy, will be closely watched.

    Success will allow Imugene to provide a superior alternative to Herceptin, which is a US$6 billion to US$7 billion per annum global market, providing significant upside.

    HER-Vaxx also has lower production costs and potentially an opportunity for a single vaccination unlike Herceptin, which requires a more expansive treatment cycle.

    Share Price Catalysts

    - Appoint CRO to run trial 1H 2015;
    - US FDA IND granted 1H 2015;
    - Appoint Principal Investigator 1H 2015;
    - Announce preclinical toxicology results 1H 2015;
    - Recruit and run lead in Phase 1b trial 2H 2015;
    - Recruit and run double-blind randomized placebo controlled Phase 2 trial 2H 2015;
    - Report Phase 1 trial results 2H 2015 to 1H 2016; and
    - Report Phase 2 results 2H 2017/1H 2018.

    Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

    May 25 12:00 AM | Link | Comment!
  • Alexium Anticipates Revenue Of More Than US$10 Million For 2015

    Alexium International Group (ASX:AJX, AX:AJX, OTC QX:AXXIY) ("Company") is pleased to provide an overview of the development of the sales pipeline for the first four months of 2015 and the outlook of the significant opportunities in the US markets for the remainder of the year.

    This year, Alexium has been focused on achieving revenue growth and expansion of its brand in the marketplace. Alexium has achieved clear and demonstrable progress toward both.

    Alexium is on target for a strong first year of revenue, as it works with more than 20 customers in pre-production, production and scale-up, with a total potential 2015 addressable market for the company of more than US$10 million.

    The revenue potential for Alexium's FR products in 2016 is significantly higher than 2015 as the company will achieve greater penetration into the initial markets, grow the defense sector potential and develop its brand in the European and Asian markets.

    In addition, the company is developing products in the building industry sector.

    Continued Advancements in the US Defense Sector

    Alexium has won selection to be funded to join the second phase of a next-generation flame-retardant (NYSE:FR) 50/50 nylon-cotton fabric with a targeted product rollout in 2015.

    In late 2014, Alexium was contracted by Batelle to provide a 50/50 nylon-cotton fabric with an environmentally-friendly flame retardant solution for the United States Department of Defense Natick Soldier Systems Center's Green Initiative.

    That fabric was delivered to Natick in April of this year and successfully passed or exceeded all of Natick's requirements, leading to Alexium being downselected to the next stages of development.

    Alexium and Natick are currently working to finalise funding for the next stage of development which is expected to run through the next several months.

    Based on historical volumes, the global market 50/50 nyloncotton fabric FR opportunity reaches over US$240 million annually, representing a huge opportunity for Alexium.

    In addition to the efforts with Natick, Alexium is actively and aggressively engaged with multiple potential customers to launch a 100% nylon FR product, which has multiple applications across the military branches, but primarily in the U.S. Army.

    Alexium is also in the final stages of commercial scale-up with a major provider of military strapping to the U.S. military. Within the military sector, Alexium:

    - Has been successfully been downselected for the Natick Green Initiative, with additional grant funding expected 2Q 2015;
    - Is working directly with a major prime contractor to the U.S. Army to develop and launch a next-generation FR Army Combat Uniform (FRACU);
    - Is in late-stage scale-up with suppliers to U.S. military in 100% nylon and strapping materials; and
    - Has estimated the 2015 revenue opportunity in the US Defense Sector at US$3 million.

    US Commercial Sector Addressable Market Update

    In addition to a very active and aggressive portfolio of defense sector product development and sales opportunities, the backbone of Alexium's 2015 revenue potential lies in the commercial sector given speed to market.

    Alexium's efforts are currently focused in three textile areas: transportation, home furnishings and outdoor fabrics.

    US Transportation Market

    Alexium continues to see strong progress in the US transportation market, which encompasses automobile, aviation and public transportation.

    This market is highly environmentally-conscious due to the enclosed nature of the spaces the fabrics typically occupy, and it has been the most aggressive in term of demanding environmentally-friendly solutions.

    The US transportation market (automotive and public transportation combined) has an addressable market size for Alexium Formulations of US$50M annually.

    In this market, Alexium has:

    - Produced samples which pass all flame retardant specifications for a total of six clients
    - Has proceeded to full-scale commercial trials for five of those clients, meeting passing performance criteria on their production equipment;
    - Already begun generating ongoing revenue from one of those clients; and
    - Estimated the 2015 revenue opportunity for Alexium in transportation at US$1.6M.

    US Home Furnishings Market

    Currently, Alexium's efforts have been most active in the home furnishings market - which includes upholstery, drapery, floorcovering and bedding - due to a number of different factors.

    First, California Law TB-117-2013, which went into effect on January 1 of this year, changed the landscape of upholstery testing, effectively driving the FR burden of the furniture away from the foam and on to the fabric, with a parallel effort in California to meet the new standard in an environmentally-friendly way.

    Secondly, the bedding industry has seen a major trend where the public is widely recognizing the role of quality sleep in general health and well-being, which is directly resulting in a large upturn in the sale of high-end mattresses and bedding, all of which require durable FR solutions.

    As a result, the durable, environmentally-friendly nature of Alexium's products are resonating within that industry, of which the FR-solution portion alone is estimated to be upwards of US$125M annually.

    In this market, Alexium has:

    - Produced samples which pass all flame retardant specifications for a total of eight clients;
    - Has proceeded to full-scale commercial trials for six of those clients, meeting passing performance criteria on their production equipment;
    - Already begun generating ongoing revenue from one of those clients; and
    - Estimated the 2015 revenue opportunity for Alexium in home furnishings at US$2.5M.

    US Outdoor Fabrics Market

    Alexium continues to make significant progress in the outdoor fabrics market (which encompasses the outdoor recreational and outdoor upholstery), an industry which has an annual flame-retardant chemistry consumption of over US$50 million.

    The two sectors of this market are among the most performance-demanding of all the markets Alexium is addressing, due to the extreme conditions FR treatments are expected to endure.

    Consumers are also among the most forward-thinking in terms of environmental consciousness, a perfect fit for Alexium's products.

    Alexium continues to work with major suppliers to these sectors to bring durable FR products to the market, and while the 2015 addressable market for this market is more modest than our other markets, the visibility and exposure of the Alexium name will be very high in this market, which we expect to lead to a much larger 2016 revenue opportunity.

    In this market, Alexium has:

    - Produced samples which pass all flame retardant specifications for two of the largest suppliers to this market;
    - Has developed a sales and marketing agreement with one of those clients, working to meet passing performance criteria on their production equipment;
    - Made substantial progress establishing a manufacturing and supply-chain presence in Asia; and
    - Estimated the 2015 revenue opportunity for Alexium in outdoor fabrics at US$3.0M.

    Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

    May 24 11:55 PM | Link | Comment!
  • Grand Gulf Energy Has Gas Production From Louisiana Well

    Grand Gulf Energy (ASX:GGE) has increased its oil and gas production with the Abita well in Louisiana cleaning up and producing 1 million cubic feet of gas and 5 barrels of oil per day.

    The company has a 20% working interest in the Abita Project and will report again on this operation once stabilised rates have been achieved.

    The gas and oil flow comes from the 17 sand, which is estimated to contain 485.4 million cubic feet of gas and 10,000 barrels of oil.

    Following depletion of the 17 Sand the company can move to produce from the 15 Sand.

    The 15 Sand is estimated to contain 1.5 billion cubic feet of gas and 30,500 barrels of condensate.

    The recompletion that was undertaken on the 17 Sand was structured to enable an easier and cheaper recompletion on the 15 Sand.

    Recent Activity

    Grand Gulf Energy recorded revenue of $1.4 million in the March 2015 Quarter on net production of 17,421 barrels of oil and 15.36 million cubic feet of gas.

    In January, the company purchased a series of NYMEX WTI put options for 2,400 barrels per month at a strike price of US$49.20 per barrel over the period to June 2015 to mitigate downside price risk.

    It also secured in March a series of NYMEX WTT put options for 3,600 barrels per month at a strike price of US$50 per barrel over the period July to December 2015.

    The company has also secured leases over the Yellowfin Project in Assumption Parish, Louisiana.

    This was developed in house using the company's proprietary 52 square miles seismic survey and targets Cretaceous Tuscaloosa sands over a 2,000 foot interval on a structural closure covering an area of 8,000 acres.

    Yellowfin follows Freeport McMoran's "Highlander" Jeanerette #1 Discovery to establish sand, pay and significant column height and multi-TCF potential in the new trend.

    Freeport's discovery is reported to host 3 trillion cubic feet with 50,000+ acres under lease and two additional wells permitted in the area.

    An initial test well will be drilled to a total depth of 27,900 feet.

    Analysis

    While the Abita well continues to clean-up, the gross current flow of 1 million cubic feet of gas per day hints at its potential to provide a boost to the company's oil and gas production.

    This could in turn drive cash flow growth.

    Grand Gulf Energy had $1.75 million in cash as of 31st March 2015. A payment of US$718,000 is also expected following a court ratifying a settlement.

    Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

    May 24 11:51 PM | Link | Comment!
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