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Aytu Bioscience AYTU Stock News

Time and time again, investors get taught a valuable lesson: invest for the longer term, and gamble for the short term. In fact, statistics show that while focused investing may lead to consistent financial gain, gamblers tend to lose almost 100% of the time using that same long-term mindset. For Aytu Bioscience investors, the path to significant revenue recognition has not been as quick as some had expected, but, it’s fair to say that AYTU may have finally caught traction in a multi-billion dollar urology market, focusing on global opportunities and commercialization of novel treatments and diagnostics. Thus, those focused on Aytu’s likely long term success should prepare to ultimately get rewarded.

Now flush with a growing pipeline of products that have either been FDA-approved or provided CE marking designation, AYTU is proving that their model of growth by acquisition is beginning to produce the investor rewards some expected months ago. The AYTU pipeline, which currently includes Natesto®, MiOXSYS®, ProstaScint®, and Fiera®, is gaining the consumer and physician attention they deserve, and recent revenue numbers and forward guidance is proving that fact.

Natesto® Sales Surge

Currently, Natesto® may stand as the most opportune product in the pipeline, and if the FDA took serious notice of the deficiencies in Natesto®’s competitive landscape, it’s likely that Natesto® would be addressing the multi-billion dollar testosterone replacement market on its own. Leaving the FDA-Big Pharma conspiracy theories aside, Natesto® has proven itself to not only be best in its class but is the obvious safe choice when it comes to overall safety and efficacy in patients treating their low testosterone levels.

In fact, Natesto® remains the only topical testosterone replacement therapy not labeled with a Black Box Warning, the most severe of disclaimers that the FDA requires for approved products that may hold serious safety and risk concern to patients. Different from FDA-approved products like AndroGel® and Axiron®, which have the Black Box Warning, and are marketed by AbbVie and Eli Lilly, respectively, Natesto® provides proven treatment without the associated and known risk from AndroGel® and Axiron®. The effects of Natesto®’s competition can be severe, with the FDA citing the potential for heart attack, increased risk of prostate cancer, reduced sperm count, or in the case of an unintentional transfer of product, cause masculine traits to emerge on female bodies. Perhaps these side effects are one of the main reasons that Natesto® sales are beginning to attract market attention away from its competitors, and at the same time generating significant and noticeable top-line revenue increases.

According to the most recent sales data released from AYTU, Natesto® sales have reached all-time highs, increasing 20% between April and May, and compounded by an additional 20% between May and June of this year. Sales results should continue to track higher, especially when Natesto® has proven to be highly effective in treating and improving erectile dysfunction on all five of the measured domains, and showed dramatic and tangible improvement in the desire for sexual activity beginning in as little as thirty days from initial use.

Generating results by being the only nasally administered therapy, 91% of patients in Aytu’s pivotal clinical trial studying the safety and efficacy of Natesto® achieved normal testosterone results by day ninety of treatment. Of those treated in the twice daily dosing of Natesto®, over 70% achieved normal testosterone levels, also by day ninety of treatment. Importantly, being dosed through nasal passageways, Natesto® has also proven its method of administration to be far superior in comparison to topical treatments, with the occurrence of an accidental transfer of the TRT product unlikely and less of a concern for those who use the product on a daily basis.

While product sales have surged recently, the share price is not reacting as it should to the increased market traction. Natesto® is addressing a $2 billion market, and by grabbing just a 10% share of sales, Natesto® could bring in over $200 million in revenue for Aytu. Additionally, if the FDA was proactive and strict in managing drugs that have been proven to cause severe health issues and even death in some patients, Natesto® may indeed be in a position to grab a significantly higher percentage of the market share. But, let’s not count on the FDA to make the sales for Natesto®, as the product can do it on its own. And, the trends in place should be a signal to investors that Natesto® is beginning to seize its opportunity to garner significant market share as the only FDA-approved, nasally administered testosterone replacement therapy. With a 300% increase in Factory Sales Units expected between the Q2 and Q4 in the fiscal year 2017, an exclamation point to the momentum is certainly warranted. To put that sales number in perspective, real demand and production show an increase in sales and orders from 1,764 units sold in Q3 of 2017 to a projected 4,248 units produced for sale by the end of the company’s 2017 fiscal year. Thus, while estimates are encouraging and investors like to hear positive guidance from management, real demand trumps all, and the focused commercial effort to drive Natesto® sales has generated record sales volume for the product.

While AYTU success is accelerating on the Natesto® front, the company is creating additional and accretive support from other pipeline products, results generated from management’s forming of a strategic initiative to fully integrate into the urology and sexual wellness market. By capitalizing on strategic opportunities, AYTU is focusing on its already commercially available products and building a focused salesforce to drive prescriptions from a product portfolio that has been de-risked from both a clinical and regulatory perspective. And, when analyzing the product pipeline, each product offers significant opportunity to generate substantial revenue increases.

MiOXSYS® Now In 20 Countries

Take MiOXSYS®, for instance. MiOXSYS® is a CE marked, male infertility device that is now sold in twenty countries and used as an infertility diagnostic system. The first-in-class “in-vitro” diagnostic device is a test available to physicians who require rapid in-office screening for male infertility. The test is unique, measuring undetected oxidative stress as an added indicator to current testing and semen analysis procedures. Working to capitalize on the United States market, MiOXSYS® is currently progressing through the U.S. regulatory process toward a 510K pathway, which should provide an abbreviated and well-defined track to approval.

Potential approval and research support gets generated from multiple prominent U.S. study sites, and the expected results will not only help to identify infertile patients quickly but will also allow immediate initiation of treatment, improving the chances of a wanted pregnancy. As a device, the company intends to exploit the razor-razorblade marketing model, generating recurring revenue from its globally patented disposable sensor technology. Considering the potential for mass adoption of this intelligent device, the opportunity is significant.

Worldwide, the male infertility market opportunity is estimated to reach $4.7 billion by 2025, with approximately 80% of that total derived from outside of the United States, countries where MiOXSYS® is already on-market. In just the first half of 2017, market placement for MiOXSYS® doubled, and Aytu expects that that placement number will double again during the next twelve months. With the MiOXSYS® device placement expanding on a global basis, including countries in Europe, Africa, Asia, Australia, and the Pacific regions, the opportunity for Aytu management to exploit global commercialization is ripe. Keeping in mind that Josh Disbrow, CEO at Aytu, has already proven himself by taking Arbor Pharmaceuticals from zero revenues to over $127 million in less than five years’ time, investors should remain confident that the same pathway to substantial sales increases can be duplicated with MiOXSYS®. But, even with a successful model already in place for MiOXSYS®, Aytu offers more to investors.

ProstaScint® Is Already FDA-Approved

Remember a key point in the thesis for considering Aytu. The company is almost entirely de-risked from FDA regulatory pressure, which serves to enhance additional opportunities presented from other pipeline products like ProstaScint®, AYTU’s FDA-approved prostate cancer imaging agent.

Clinical performance for ProstaScint® has been close to perfect, returning results with greater than 95% accuracy, along with durable and positive predictive value in patients. When the ProstaScint® agent gets used in combination with either single-photon emission or computed tomography, the accuracy in cases of profiling high-risk patients with Gleason levels of 8-10 provided results of between 95.7% and 100% when evaluated for accuracy, sensitivity, and positive predictive value. Now, with both SPECT and CT routinely made part of a prostate examination, Aytu believes that the results generated by ProstaScint® offer a compelling case for use in clinical evaluation, and is strategically adding the product to the sales team’s arsenal of marketable therapies.

The opportunity is, once again, significant. The global prostate cancer drug market has grown beyond $7 billion in 2016, up from only $2.5 billion in 2011. With an estimated ten drugs either in late-stage development or commercially available, the market is looking for reliable screening alternatives that can catch the disease in its earliest stages. The issue is serious, with prostate cancer identified as the second most common form of cancer in men, with an estimated 240,000 new cases reported each year. When diagnosed early, performing a prostatectomy in combination with radiotherapy has resulted in virtual five-year survival rates in patients 100% of the time. However, that’s in the cases where cancer gets identified in the early stages. Poorer diagnosis and screening lower five-year survival to just 37% in patients, demonstrating the importance of having reliable and sensitive measures in place to detect prostate irregularities. So, it’s not a matter of “if” the market needs an agent like ProstaScint® to accentuate the results, it’s more a question of how the Aytu sales team can effectually manage its multiple market opportunities to drive sales.

In a nutshell, the “so-called” issues facing Aytu growth are not problematic at all. With four products either in the pipeline or already commercially available, building its salesforce takes time. Each product has multi-billion dollar potential, and each requiresit’s the company’s dedicated team of professionals to drive those opportunities. So, for investors, the short-term growth pains that have stagnated the share price may, in time, generate exponential returns as the company continues to implement its marketing plan. But, Aytu’s strategy to drive growth and value opportunity does not stop at the three products already discussed. A fourth has emerged, and its future is just as promising.

Fiera® Added To Aytu’s Product Arsenal

The first products in the Aytu pipeline were, for the most part, designed to assist men in either sexual dysfunction symptoms or with cancer screening. However, expanding on its opportunities to grow through acquisition when appropriate, Aytu purchased Nuelle, Inc, on May 5, 2017, acquiring the rights to Fiera® in the process.

Developed by Nuelle, Fiera® was born out of thorough and significant clinical evaluation and validated by extensive consumer research. Already commercially available, Fiera® is gaining attention from the over 43% of women that have identified as having one or more sexual concerns. And, the market is substantial, with an estimated 53 million women in the United States alone meeting the clinical criteria as having sexual dysfunction issues.

Fiera® is the first pre-intimacy device proven to increase sexual desire and arousal in women, utilizing two clinically validated technologies of suction and stimulation to enhance blood flow to areas of the vagina that induce sexual interest and desire. Fiera® has generated highly favorable reviews, and in almost 90% of all responses, females expressed that the mood for sex, the enjoyment of sex, the looking forward to sex, and the excitement about sex improved significantly. An additional set of responses favored Fiera® for its ability to generate enhanced sexual intimacy, heightened orgasms and pleasure, and a greater feeling of arousal.

As is the case for each of the other products being developed and marketed by AYTU, Fiera® offers substantial market opportunity. The global market for female sexual dysfunction is increasing at a significant pace, and the awareness of having options available to address the issues is growing accordingly. Because of the technological advances and research capabilities, North America dominates the current female sexual dysfunction market. However, markets in countries throughout Asia and Europe are quickly developing, and are expected to create meaningful opportunities in the next several years. The growth rates of female sexual dysfunction should continue to bode well for AYTU, as Fiera® is already on the market and is targeting the estimated $4 billion market that continues to grow. Now with Fiera® in hand, Aytu can take advantage of the exploding market potential outside of the United States, noting that Fiera® is the only scientifically validated, with clinical device to contribute to decreasing or eliminating sexual dysfunction measures in women, and the only to improve pre-intimacy sexual desire.

How Aytu Bioscience Brings It All Together

Although Aytu has the ingredients in place to deliver exceptional growth, it will take vision, strategy, and focus to deliver tangible results. Led by an experienced management team and an independent BOD, Aytu is proving its capability to achieve their desired results. Although the share price is not reflective of the inherent value of the company, the track record of the leadership team has been shown to be reliable, as Natesto®, ProstaScint®, MiOXSYS®, and Fiera® are already commercially available in worldwide markets. Since the launch of Natesto® in August of 2016, quarterly sales have continued to increase, and the product is supported by a fully developed commercial infrastructure.

To capitalize on the opportunities presented by both ProstaScint® and Fiera®, the company is building its professional sales presence in the U.S. and is further developing its distribution channels to take advantage of an increasingly global market. The opportunity held by MiOXSYS® is also compelling, and any company would likely be able to realize serious potential from that product alone, but for Aytu, it’s only one piece of a well-defined and niche oriented product portfolio.

According to management, the strategy is in place to continue to acquire late-stage urology pipeline products that can be quickly accretive to company revenue and asset growth. Enhanced by patent protection, the vision to build upon its income generating base of treatments not only provides an opportunity for proper valuation multiples to be applied but creates an asset base for a future strategic opportunity. Aytu sports a team of sixty employees, and with forty dedicated salespeople in place, the focus on developing product sales and opportunity has moved to the forefront of the business. Concluding a bolstering of its sales force several months ago, Aytu is lean, focused, and determined to deliver shareholder value in the near term.

The current market cap of less than $6 million borders on ridiculous for a company that has four products commercially available and entirely de-risked from a regulatory perspective. And, with only 16.4 million shares currently outstanding, Aytu has capital leverage and availability to add to their portfolio should an attractable acquisition candidate emerge. Insider ownership at roughly 20% of the outstanding shares also works to align insider interest with that of the retail and institutional holders, thereby magnifying the allegiance to increase shareholder value in an accretive and non-dilutive manner when appropriate. With a product arsenal that is growing at a significant pace, and with plenty of product adoption still available to the company, Aytu, at these levels, deserves serious investor attention. As long as investors recognize that an investment into Aytu may take a quarter or two to develop fully, the ultimate reward may pay significant returns, especially once all four of its products begin to absorb substantial market attention.

In a market that teeters on volatility, staying course with a company like Aytu Bioscience, which has significant assets available for commercial market penetration, may prove to be far less risky than many perceive -and the opportunity, especially at currently depressed prices, may be ripe for the taking.

Disclaimer- CNA Finance is NOT an Investment Advisor. Our goal is to bring both news and under discovered stocks to the attention of investors to assist in making smart decisions in the market. CNA Finance is a for profit company. That profit is generated through three (3) different types of relationships. First and foremost, we work with pay per click and CPM advertisers on banners. We also have affiliate relationships with various companies where we earn a portion of the sales we refer. Finally, we may have relationships with some of the companies or IR firms that represent companies mentioned within our works in which we are compensated in cash and or stock for consulting, investor relations, and Press Release services. Hart Partners paid CNA Finance $3,500 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Aytu Bioscience by CNA Finance. All information researched and provided through any article associated with Aytu Bioscience and published on CNA Finance is public information that is documented and available upon request. CNA Finance encourages all investors to seek professional advice before making any investment decision.

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Mirage Energy MRGE Stock News

With the revival of the oil and gas exploration industry, it’s no secret that many emerging companies are finding innovative and economical ways to extract the precious minerals from the ground. What was once a game for the oligopolist giants in the industry has become a far more level playing field, allowing small and emerging companies to utilize innovative and inexpensive synergies that offer great opportunity to capitalize on either production or storage initiatives.

What hasn’t changed, though, is that the oil and gas exploration business is still a boom or bust prospect. But, even so, the rewards for success can be a thousand times greater than the loss, and opportunity is ripe for the taking on a global scale. And, speaking of the global opportunity, a particular company is putting the pieces in place to undertake one of the most ambitious multi-billion dollar mid stream projects ever to be constructed in Mexico, and you’re entitled to an introduction. Meet Mirage Energy Corporation.

Now, what MRGE is working to put in place is no run of the mill project. In fact, the uber-ambitious plan being spearheaded by longtime oilman, Michael R. Ward,won’t require his company even to purchase a pump, or use 3D seismic technology, or utilize any of the new innovative instruments that some companies are using to hedge their bets and stay away from dry holes. No, MRGE wants to do something far less risky…they simply want to store natural gas product for their customers. And, since natural gas is continuing to be brought to the surface for sale to an increasing marketplace, MRGE’s business strategy is likely to be met with strong demand. What should make the project more enticing to investors is that MRGE is attempting to do what no other company has ever done before in Mexico, and once implemented, has the potential to return to the company a billion dollar payday. Even better, the project can be duplicated by MRGE throughout the country of Mexico.

The project is expensive, but with creative financing options, MRGE expects to place the first underground natural gas storage facility inside the Mexican borders within the next eighteen months. To accomplish this aggressive pace of construction, MRGE needs permits, and it’s assuring to note that MRGE has nearly all of the permits ready to file. And, with these allowances lining up for project commencement in late 2017, MRGE’s historic project may reap enormous benefit from its almost three-quarters of a billion BCF gas storage unit that producers have shown tremendous interest in using. So much so, that MRGE has told the markets that the completed storage unit is expected to be fully leased based on current interest.

The project isn’t simple, but the company is well on their way to fulfilling their objective by taking advantage of strong relationships within the Mexican regulatory agencies and from expertise provided by a host of reliable and well-respected industry contractors. If all plays out according to plan, MRGE is expected to have the project completed by late 2018 – and, here’s how the project should flow.

What’s in the Pipeline?

Before we get into the details, allow me to provide a summary of what the company plans to do, and why it has the potential to return a huge profit for investors. As stated earlier, MRGE intends to construct a massive natural gas storage facility in Mexico, allowing the company to provide a much-needed service to producers and suppliers of natural gas. The project is scheduled to construct an initial underground storage field, with capacity set to house 52 BCF of natural gas in the first phase of the project. Upon completion, storage capacity is expected to house roughly 786 BCF, making it one of the largest natural gas storage facilities of its kind. The scope of the project provides for an integrated pipeline that can transfer and store natural gas for any entity willing to pay the storage fee, making it both accessible and available to any production or supply company. The transmission pipelines, which deliver the gas, are being designed to add 800 mmcf per day into Mexico. This increase is necessary because currently less than 70% of Mexico’s consumption of natural gas is produced in the country, making the market unstable and potentially prone to disruption for its infrastructure requirements. What MRGE is looking to do, besides creating significant shareholder value, is to provide a means for Mexico to secure itself with energy security and stability by allowing for reserve replacement and price effective marketing.

The MRGE project should pique the interest of those with an understanding of Mexico’s current economic climate, as the country’s government is working to improve self-stability and growth in the wake of rising US import costs. Fearing a dependence on US natural gas imports, Enrique Peña Nieto, the president of Mexico, has passed eleven national reforms to strengthen the country’s self-sufficient capabilities. Mexico plans to invest over 170 billion pesos (roughly $9.6 billion USD) into over 10,000 kilometers of new pipelines during the next few years, a plan designed to accommodate the country’s continuously increasing supply of natural gasses. Projections site that natural gas needs are expected to rise to 10,400 million cubic feet (mcf) in 2025 from the current 5,700 mcf. With all this in mind, investors should be able to see that projects focused on natural gas opportunities in Mexico are ripe for the taking, and MRGE has entered the sector at a fitting time.

Now, MRGE may have taken on an ambitious strategy to build this facility, but the company management does have the skill to back up their plans. The company’s President and CEO, Michael R. Ward, has over 45 years of experience in the oil field and has laid down a solid foundation for the upcoming years at Mirage Energy Corporation. Well in the process, MRGE is close to securing all necessary permits through Mexico’s regulatory agencies for natural gas storage and expects to receive final approval to begin construction by the last quarter of 2017. Already, MRGE has been steadily acquiring the required documents to file by working through the administrative procedures with CNH, CENAGAS, SENER, and CRE, the governing oversight which all play a crucial role in granting permission for the project to commence.

The company has also already started work on structural procurement and plans to continue doing so for the next few months. Of course, the process of building a natural gas storage facility requires a substantial sum of cash, and CEO Michael R.Ward has already set numerous plans in motion to help MRGE secure an adequate supply of funding to realize the company’s goal without any unexpected setbacks. For example, the company is likely to see funds coming in through new partnerships or working interests that may become likely later in the construction schedule; Ward has even spoken about laying off some of his ownership of the company as collateral should it prove necessary.

Start-Up Plans In September of 2017

Construction, estimated to commence in September of 2017, is the next step in MRGE’s playbook. The company has selected six preferred contractors and is in the process of negotiating the most beneficial contract to maximize profit. Each contractor that MRGE has engaged is experienced and well-respected in the business, specializing in pipeline and industrial plant construction. Exterran, one of the company’s top choices, is well known as a premier contractor in the industry. Headquartered in Houston, Texas, Exterran offers solutions to nearly all of MRGE’s construction needs, from the pipeline to the facility. Arendal, another preferred contractor to MRGE, is a respected contractor headquartered in Monterrey, Nuevo León. Having participated in over 63% of pipelines built in the last ten years, Arendal is committed to developing Mexico’s energy infrastructure through their construction of pipelines, industrial plants, and other civil works. Along with these two companies, MRGE also has a slew of subcontractors, and other vendors to choose from should additional services prove necessary. However, regardless of who MRGE continues to work with, the options in place provide confidence in allowing the company to complete their project plans in line with their aggressive schedule.

Clearly, Mirage Energy is a small company with massive plans, which is a combination that may raise the eyebrows of many investors. But, as shown by their detailed timeline and already considerable progress, MRGE knows what they are doing, and are dedicated to action. And, if everything continues to fall into place for MRGE, profit for the company and investors could be substantial.

Ambition Plus Demand Equals Enormous Potential

Taking the sum of the parts, the project by MRGE may seem mighty ambitious for a small company. But, in actuality, MRGE may have found the right niche, the right country to pitch the plan, and a customer base that is eager to use the facility. Investors who failed to recognize oil field ingenuity have lost many historic paydays, and not taking MRGE seriously may again lead to missed investment windfalls. No, this deal is not a sure thing, but, investors who have been around for awhile have learned to not judge an investment from its name only, but to look beneath the surface of a deal to see hidden opportunity that can return gains along the way.

Perhaps that is what is intriguing about this deal. With MRGE already well into the licensing process in Mexico, the company opens itself up to partnership opportunity from much larger players that join the vision and understand the potential of the completed project. Keeping in mind that this is only the first storage facility planned, the revenue opportunity can grow exponentially when accounting for potential future development. With company management having the ability to make deals and incorporate creative ways to finance the project, chances lay in favor of MRGE completing the storage project. Once done, it becomes a cash cow, and managing a facility has far less risk than owning a rig, pump, or a fracking drill. All in all, investors who believe that MRGE can raise the capital, either through partnership, leverage, or capital raises, should find an investment into MRGE a potentially lucrative opportunity. For those who usually watch from the sidelines, the view may get somewhat frustrating, especially when pieces of this project begin to come together in a meaningful manner.

Avoiding ambitious projects remains a mainstay to investors with a conservative investment style. However, for those who keep a portion of their investment dollars set aside for high-risk, high-reward opportunities, MRGE may be the ideal candidate to deliver exponential gains. But, as with all investments, only risk what you can afford to do without, and always stay apprised of news and company developments. With the MRGE project set to undertake multiple phases before completion, investors can expect to be kept informed on project milestones, allowing for accretive gains in shareholder value along the way.

Disclaimer- CNA Finance is NOT an Investment Advisor. Our goal is to bring both news and under discovered stocks to the attention of investors to assist in making smart decisions in the market. CNA Finance is a for profit company. That profit is generated through three (3) different types of relationships. First and foremost, we work with pay per click and CPM advertisers on banners. We also have affiliate relationships with various companies where we earn a portion of the sales we refer. Finally, we may have relationships with some of the companies or IR firms that represent companies mentioned within our works in which we are compensated in cash and or stock for consulting, investor relations, and Press Release services. World Wide Holdings paid CNA Finance $3,000 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Mirage Energy by CNA Finance. All information researched and provided through any article associated with Mirage Energy and published on CNA Finance is public information that is documented and available upon request. CNA Finance encourages all investors to seek professional advice before making any investment decision.

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Freeport-McMoRan Inc FCX Stock News

Freeport-McMoRan Inc (NYSE: FCX) is off to an incredibly strong start to the trading session today, and for good reason. The company reported earnings, and while EPS came in slightly lower than expected, strong revenue is proving to be a source of excitement among investors. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:36), FCX is trading at $14.57 per share after a gain of $1.61 per share or 12.42% thus far today.





FCX Gains On Strong Earnings

As mentioned above, Freeport-McMoRan is having an incredibly strong day in the market today after releasing its results for the second quarter. While earnings slightly missed their mark, investors seem to have a keen focus on revenue, which proved to be positive. Here’s what we saw from the report…




  • Earnings Per Share – When it comes to earnings per share, FCX didn’t have the best quarter in the world. During Q2, analysts expected that the company would generate $0.20 per share in earnings. However, the company missed the mark by $0.03, reporting earnings per share in the amount of $0.17.
  • Revenue – Although revenue didn’t quite hit the mark for the second quarter, FCX did incredibly well when it came to top-line revenue. During the quarter, analysts expected that the mining company would generate revenue in the amount of $3.66 billion. However, the company actually generated revenue in the amount of $3.71 billion, topping expectations.

Another big factor here is copper prices. While the company did reduce its guidance with regard to the total amount of copper it plans on producing throughout the year, that is likely to largely be offset by an increase in prices. This increase is being caused by a mix between a weak USD and growing copper demand in China.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on FCX. In particular, we’re interested in following copper prices, as gains there seem to be the primary driver of gains in the stock to come. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Gevo, Inc. GEVO Stock News

Gevo, Inc. (NASDAQ: GEVO) is having a great day in the market thus far today, and for good reason. The company announced that its isobutanol is now ready for licensing. Of course, this led to excitement among investors, prompting gains in the stock and leading to an alert from our partners at Trade Ideas. At the moment (10:03), GEVO is trading at $0.79 per share after a gain of $0.07 per share (9.03%) thus far today.





GEVO Announces Isobutanol Licensing Availability

As mentioned above, Gevo is having an incredibly strong day in the market today after a key announcement that was made at the BIO World Congress on Industrial Biotechnology in Montreal, Canada. Praj and Gevo jointly announced that isobutanol technology will now be available for licensing to processors of sugar cane juice and molasses.




In the Gevo’s technology using sugar cane and molasses feedstocks. This led to the development and process design package that is now available for commercialization of cane juice and molasses-based ethanol plants. It is expected that this licensing will be focused on Praj plants that are located in India, South America, and Southeast Asia. The initial capacity under the agreement is targeted to come online between 2019 and 2020. In a statement, Dr. Patrick Gruber, CEO at GEVO, had the following to offer:

We are pleased with the work that Praj has done in adapting our technology using cane juice and molasses as feedstocks. Praj is a great partner who shares our vision of low carbon fuels made from sugars in high yields. Praj has a massive footprint across the world. We look forward to working with Praj to license the technology out, leveraging their access and capabilities…”

The above statement was followed up by Pramod Choudhari, Executive Chairman at Praj. Here’s what he had to say:

We are excited to offer this technology to our global customers who stand to benefit from an additional revenue stream from isobutanol. Praj has worked on 750 projects for ethanol plants across 75 countries. This isobutanol platform can be offered as ‘bolt-on’ to an existing ethanol plant or as a greenfield plant. This isobutanol technology is the latest addition to Praj’s diverse product portfolio and reinforces our organization’s leadership in the bioenergy space.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on GEVO. In particular, we’re interested in watching to see how the agreement with Praj turns into revenue and profits as the isobutanol technology is licensed out. We’ll continue to follow the story closely and bring the news to you as it breaks!

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AK Steel Holding Corporation AKS Stock News

AK Steel Holding Corporation (NYSE: AKS) is having an overwhelmingly strong day in the market today, and for good reason. The company announced earnings, proving to have a much better quarter than expected. This led to excitement among investors, causing gains and prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:49), AKS is trading at $6.62 per share after a gain of $0.59 per share or 9.87% thus far today.





AKS Reports Strong Earnings

As mentioned above, AK Steel is having an overwhelmingly strong start to the trading session this morning after reporting earnings for the second quarter. Here’s what we saw from the report…




  • Revenue – In terms of revenue, AKS did incredibly well. During the quarter, analysts expected that the company would generate revenue in the amount of $1.46 billion. However, the company actually generated revenue in the amount of $1.56 billion. Not only did that beat estimates by $10 million, but it also proved to be a 4.7% year over year gain.
  • Earnings – Earnings was another area where AKS definitely did not disappoint. During the quarter, analysts expected that the company would generate earnings in the amount of $0.12 per share. However, the company actually reported earnings in the amount of $0.19 per share.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on AKS. In particular, we’re interested in watching to see if the growth will continue. While shipments were down, the company was able to leverage pricing and bring the growth. We’re excited to see if this will continue. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Diana Containerships DCIX Stock News

Diana Containerships Inc (NASDAQ: DCIX) is having an overwhelmingly strong start to the trading session in the pre-market hours today, and for good reason. The company reported its earnings for the second quarter, causing excitement among investors and leading to gains. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:19), DCIX is trading at $0.73 per share after a gain of $0.23 per share (45.98%) thus far today.





DCIX Flies On Earnings

As mentioned above, Diana Containerships is having an overwhelmingly strong start to the day in the pre-market hours after reporting its earnings for the second quarter. The earnings showed incredible year-over-year growth. Here’s what we saw:




  • Sales – While sales came in a bit lower than expected, earnings per share clearly blew expectations out of the water. We’ll get to earnings in a second; let’s start with sales. During the quarter, analysts expected that DCIX would generate $6.8 million in sales. However, the company actually generated sales in the amount of $5.498 million.
  • Earnings – While sales didn’t quite hit the mark, earnings definitely proved to be great. During the second quarter, the company generated earnings per share in the amount of $17.27. That’s an incredible jump from the loss of $6.13 per share that the company experienced in the same quarter last year.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on DCIX. In particular, we’re interested in seeing if the company can keep the exceptional earnings growth coming. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Youngevity International YGYID Stock News

Youngevity International Inc (NASDAQ: YGYI) is likely to have a strong day in the market today after announcing that it has appointed a new member of the management team. This comes after a slurry of news on the stock and shortly following the company’s listing on the NASDAQ.





YGYI Welcomes Luke Taffuri To The Management Team

As mentioned above, Youngevity International is likely to have a strong day in the market after announcing the appointment of Luke Taffuri to its management team. Taffuri has been appointed as the VP of International Sales and Operations. With him. Mr. Taffuri brings more than 22 years of direct selling experience in various positions. One of those positions was the Chief Operating Officer at Sorvana International, a company that YGYI recently acquired.




This is an important piece of news. After all, YGYI has been building the list of countries in which it operates. This combined with recent acquisitions that have increased geographic expansion, the need for a management position in the international sales and operations space has grown. Today, YGYI is operating in eight Asian Markets while growing its presence in Latin America and Eastern Europe. In a statement, Steve Wallach, Chairman and CEO at Youngevity, had the following to offer…

Our entire management team is very excited to announce the creation of the VP of International Sales and Operations role, and believe we found the perfect candidate in Luke Taffuri. As we continue to transition into a global company, we believe Luke’s experiences and industry relationships should optimize the international growth potential that exist in Youngevity today.”

The above statement was followed up by Mr. Taffuri, who had the following to offer…

I am impressed with what Youngevity has in place for their current international markets from an operational, technological, and product offering standpoint. I am most impressed, however, with the quality of the people and the culture that has been built throughout the organization. They have a great foundation illustrated by their 20 year history which I believe will lead to more efficient and productive transitions in the international marketplace. Initially I will focus on driving revenue growth across the global platform. As markets begin to scale I will set my sites on operational efficiencies and profitability.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on YGYI. In particular, we’ll be watching to see how Mr. Taffuri expands revenue and profitability on the global scale. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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VBI Vaccines, Inc. VBIV Stock News

VBI Vaccines, Inc. – Ordinary Shares (NASDAQ:VBIV) now has a clear route to market for its lead development asset, a hepatitis B vaccine called Sci-B-Vac. The drug is already approved in certain regions globally and is a standard of care therapy in Israel, but in the markets where the real money is (the US, Canada, and Europe) it remains non-commercially available. VBI has spent the last twelve months readying the asset for a pivotal clinical program that could serve as the final step along the development pathway and – as per the company’s latest release – this step is now underway.





The hepatitis B market

With the release in question, management has outlined the protocol and design of a phase III program that will serve to underpin registration submission with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada (HC). Analysts suggest that the hepatitis B market will expand to be worth $3.5 billion by 2021. Of this $3.5 billion, eight major markets account for nearly 75% of the total figure – the US, Canada, the UK, France, Germany, Italy, Spain, and Japan. An approval from the FDA, the EMA and HC would allow VBI Vaccines (NASDAQ:VBIV) to target seven out of these eight regions, meaning the company would be going after a market worth somewhere in the region of $3.15 billion, with this calculation based on the assumption that each of the eight regions account for an equal portion of the total market, which is very conservative.

The importance of the just announced program, then, is clear.




A look at the clinical program – overview

Using the company’s just released protocol, here’s a breakdown of what the company is planning to conduct and how it plans to do it.

The program is a phase III global program that will enroll around 4,800 patients spread across the three target regions – the US, Europe and Canada. It’s set up to include two separate phase III studies, the data from which VBI will collate at completion and submit to the relevant authorities. The ability to base three submissions on a single program (the two trials) shouldn’t be overlooked here. Phase III trials are expensive. For a company like VBI Vaccines (NASDAQ:VBIV), which is at the smaller end of the biotech spectrum, research and development costs can be a make or break input. One program means one third of the cost, which means investors are being asked to take on a much-reduced risk (primarily rooted in reduced capital requirement mitigating the necessity to raise funds via an equity raise and – in turn – reducing the risk that the company will dilute shareholders to any substantial degree) when they pick up an exposure to this program.

The clinical program – the first phase III study

The first of the two phase III studies is designed to pitch Sci-B-Vac against the current standard of care vaccine in the hepatitis B space, GlaxoSmithKline plc (ADR) (NYSE:GSK)’s Engerix-B. If the company is going to get Sci-B-Vac approved as a hepatitis B vaccine in its major target regions, it’s going to need to show that the asset can induce seroprotection in standard population patients – in this instance, defined as healthy subjects aged 18 years and over. There’s also an added focus, targeting patients aged 45 years and older (more on this shortly).

There are two primary endpoints in place.

The first primary endpoint is geared towards the necessity to prove that Sci-B-Vac is as good as Engerix-B in ages 18 years plus, with the endpoint hit defined as Sci-B-Vac demonstrating non-inferiority to the standard of care drug as measured by the the seroprotection rate induced four weeks post final dosing (total administration involves three doses of each vaccine).

The second primary endpoint is designed to show that Sci-B-Vac can outperform Engerix-B in patients ages 45 years plus. This is an endpoint that markets are going to be watching incredibly closely because, if hit, it will create a major differentiation between the two vaccines involved in the study, favoring Sci-B-Vac. VBI has long pitched its vaccine as having the potential to be a better option for immunosuppressed patients. These are patients that, for a variety of reasons, have a sub-optimal immune system. When the immune system doesn’t work optimally, it won’t create the antibodies that are at the root of the mechanism of action (MOA) of prophylactic vaccination. By including more hepatitis B specific antigens in Sci-B-Vac than there are in Engerix-B, VBI Vaccines (NASDAQ:VBIV) is hoping to increase the number and variety of antibodies that form post-administration. This, in theory, should improve the degree of seroprotection for this immunosuppressed category of patients. In this instance, and with this study, the immunosuppressed group is over 45 years, with the immunosuppression rooted in age.

The clinical program – the second phase III study

That’s the first study. The second study is a lot to lot study that, again, compares VBI’s asset with Engerix-B. Patients in this one will be randomized to receive either Sci-B-Vac or Engerix-B, with three out of four patients receiving the former. The Sci-B-Vac patients will be further split into three groups, each of which will receive a version of the vaccine from a particular lot.

The primary outcome of this study is to demonstrate that the geometric mean concentration (GMC) of antibodies is the same across each lot of Sci-B-Vac. It’s basically a quality control arm. While the company hasn’t specifically served up its reasoning behind including this type of study in its program, it’s reasonable to conclude that the regulatory authorities across the target regions requested it so as to ensure that the drug can be produced in varying geographies and can be transported from one region to another without deteriorating in quality. If this is the case, it’s a small price to pay for the ability to conduct one global study and to use the results of this study to apply for approval in three major regions.

In addition to the GMC of antibodies across the three lots, the company will also measure the safety and efficacy of the three lots as compared to one another and to Engerix-B as a secondary endpoint. The assumption here is that this data will be used to reinforce the data collected from the first of the two phase IIIs as and when VBI submits for registration.

Conclusion

The initiation of this program is something that VBI shareholders have been waiting for patiently for the last twelve months. That the company now has its protocol in place and some solid timeframes to work with (initiation during the second half of 2017, fifteen months to trial completion) makes VBI Vaccines (NASDAQ:VBIV) a far less speculative exposure than it was just a few weeks ago and, as a result, the company will likely benefit from an inflow of speculative volume rooted in investors taking a position ahead of the trial’s initiation and eventual outcome.

VBI is not without its risks, of course. This is development stage biotechnology and the future success of the company in hepatitis B relies on an upcoming binary event (the outcome of this phase III program) being favorable. If it’s not, VBI will struggle to reestablish a presence in this sector going forward. With that said, the existence of real world data from the nations in which this drug is already approved and the data set that the company has put together to date (which includes safety and efficacy data from more than 2000 patients) serves to reduce this risk considerably.

Disclosure: The author has no positions in any of the stocks mentioned.

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Top Ships TOPS Stock News

Top Ships Inc (NASDAQ: TOPS) is having an overwhelmingly strong day in the market today as rumors start to surface surrounding the company. The rumor, suggesting that the company will soon see an acquisition, is causing excitement among investors, sending the stock upward and prompting our partners at Trade Ideas to alert us to the movement. At the moment (11:10), TOPS is trading at $0.60 per share after a gain of $0.34 per share (129.12%) thus far today.





TOPS Gains On Takeover Speculation

As mentioned above, Top Ships is having a strong time in the market today after rumors started to pop up that the company will soon be acquired. The rumors started to fly yesterday when they were started by Sierra World Equity Review. On the website, Sierra says that John Fredriksen is going to acquire TOPS within the next 30 days. While the publication does not suggest at what price the acquisition may happen, they seem to be adamant that it’s likely.




Keep in mind that we see rumors in the market all the time. Sierra World Equity Review has provided two of those rumors in the past month, the first of which didn’t pan out. Chances are that this is nothing more than speculation. At the end of the day, rumors are just that – they are rumors. So, if you’re going to trade on this, make sure to do so with caution.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on TOPS. In particular, we’re interested in finding out of Sierra got it right this time. While we don’t believe that this acquisition is going to take place, anything can happen in the market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Novavax, Inc. NVAX Stock News

Novavax, Inc. (NASDAQ: NVAX) is having yet another incredible day in the market today, and for good reason. Today is the day of a key update that investors have been waiting for. Of course, the excitement continues to build after the stock climbed around 50% since July 17th. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:44), NVAX is trading at $1.72 per share after a gain of $0.24 (16.22%) thus far today.





NVAX Climbs Ahead Of Update

As mentioned above, Novavax is having an incredible day in the market today as we get closer and closer to a very important conference call. The rally started on July 17th, after the company announced that it would be hosting a conference call and webcast today. The call will be held at 4:30 ET and the information to get involved is below.




This particular call surrounds topline data from a recent Phase 2 Safety and immunogenicty trial of the RSV-F vaccine the company has been working on for adults 60 years of age and older. NVAX also said that it will be providing updated information with regard to prior Phase 2 and Phase 3 clinical trials in older adults and its RSV Phase 3 clinical trial for infants via maternal immunization. Here is the agenda for the webcast:

  • First NVAX will announce topline data from the Phase 2 safety and immunogenicity trial in older adults.
  • The company then intends to provide additional findings associated with previous Phase 2 and Phase 3 clinical trials in older adults.
  • Finally, NVAX will provide an update on the Prepare(TM) clinical trial for infants via maternal immunization.

If you’d like to take part in the study, you can do so by either calling in or clicking at 4:30 ET tonight. Here’s the information:

  • Call In – If you plan on calling into the Novavax presentation, you can do so by calling (877) 212-6076 if you’re in the United States or calling (707) 287-9331 if you are not. The passcode for the call is 54820069.
  • On The Web – You can also log into the webinar by going to www.novavax.com.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on NVAX. In particular, we’ll be listening to the presentation later today, and we are overwhelmingly excited to learn more about the data. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Thought Leader Discussions

Gevo, Inc. GEVO Stock News

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Gevo, Inc. (NASDAQ: GEVO) Before we get into this interview, I'd like to extend a special thanks to my friend Joey who both set up the...