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Aytu Bioscience Inc AYTU Stock News

Aytu BioScience has been on a roll, raising investor eyebrows from the growth of Natesto®, the company’s testosterone replacement therapy treatment. Investors following that story know that Natesto® is recording robust and sequential increases in new prescription and factory orders of over 300% since the second quarter of the fiscal year 2017, and a more than 411% increase over the same quarter in 2017. However, slightly hidden by the fanfare from Natesto® is MiOXSYS®, AYTU’s novel, rapid semen analysis system that is gearing up to become the standard of care diagnostic system designed to assess male infertility caused by oxidative stress. And, it’s time that MiOXSYS® grabs some more attention.

MiOXSYS®, another approved for market treatment offered from AYTU, is already commercialized outside the U.S. market, capitalizing on its status as a CE Marked, Health Canada cleared product. But, don’t worry, AYTU is not planning to ignore the vast potential of the U.S. market and is in the process of finalizing plans to initiate U.S.-based clinical trials in pursuit of 510(k) medical device clearance by the FDA. For AYTU, MiOXSYS® compliments the strategic plan of optimizing its portfolio of revenue-generating urology products, leveraging off the expertise of its management team that has shown success in building and bringing to market leading brands in specialized, multi-billion dollar markets.

More Good News For MiOXSYS®

Last week, AYTU announced that the Australian Therapeutic Goods Administration granted market approval to the MiOXSYS® system for inclusion on the Australian Register of Therapeutic Goods. The approval acknowledges the value of MiOXSYS® as a viable and reliable tool in the diagnostic assessment of semen quality for patients undergoing male infertility evaluation.

For AYTU, this latest approval by the TGA adds to the placement momentum and positions MiOXSYS® to take advantage of the one in six couples in Australia that suffer from infertility, with an estimated 50% of the cases attributed to male factor infertility. The approval permits AYTU to strategically penetrate the Australian markets to identify and help treat men with suspected infertility where oxidative stress is implicated.

The approval further lays the foundation for AYTU management to expedite its strategic plans to develop targeted sectors of the Australian markets, with management guiding toward the likelihood of adding distribution partners that can further introduce the MiOXSYS® system for clinical use in the coming quarters. Once the agreements get finalized, MiOXSYS® will advance the AYTU pipeline of revenue-generating products addressing multi-billion dollar opportunities, with limited exposure to regulatory pressures that its competitors face by being mired in mid to late-stage clinical trials. For AYTU, the MiOXSYS® system offers the market more than just a new system. The MiOXSYS® solution provides the most comprehensive, state-of-the-art diagnostic designed to generate results almost immediately. And, in most cases, the test can be administered by an office technician, a stark departure from current testing practices that often require well-trained professionals and several hours, or even days of analysis before providing the patient with test results.

MiOXSYS® Is Transformative To Current Standard of Care

Beyond its advantages in speed and accuracy, the MiOXSYS® system offers a solution from the need of expensive and sometimes bulky set-ups that have historically produced unreliable oxidative stress level results, often generated from these now antiquated and difficult-to-use systems.

For practitioners, investing in the latest and most efficient device, MiOXSYS®, will help to alleviate practice disruptions, limiting unreliable oxidative stress level results associated with the use of competitive devices. Beyond generating reliable data, the MiOXSYS® system can provide complete oxidative stress testing quickly, a significant advantage to what has historically taken several hours to complete. The MiOXSYS® test requires no specialized training for administration, can go from box to patient in a matter of minutes, and provides a comprehensive set of results in less than five minutes. The results provide rapid, reliable measures for oxidative stress levels. The importance of determining oxidative stress levels is critical to the clinician, who can target specific treatments to lower oxidative stress and increase the chances of pregnancy.

The Impact Of A Successful Launch

For AYTU investors, management has guided toward an achievable goal, which is to place an estimated 200 MiOXSYS® systems worldwide by the end of 2018. Currently, 96 systems are in use around the world. Once the goal gets met, management expects that each system may generate roughly of $20,000 per year each, totaling to an estimated revenue run rate more than $4 million in annual sales. Utilizing the razor-razorblade sales model, AYTU, or its licensed partners, would provide the disposable components required for each test, allowing the MiOXSYS® system to continuously generate revenue with a low cost, high-margin business model.

Keep in mind that while these projections would deliver a substantial spike in the revenue run rate, they do not include the potential from United States distribution. Management knows this better than anyone, and they are working toward a successful 510(k) medical device FDA approval, which would increase the market opportunity substantially, likely causing the placement projections to get revised sharply higher. And, for those that doubt the effectiveness of the MiOXSYS® system, no less than six papers have been published in prominent peer-reviewed journals and publications that substantiate the system’s value for providing a detailed, accurate, and reliable representation of male infertility analysis.

For AYTU and their investors, the most recent Australian expansion serves as another stepping stone toward a worldwide placement with a game-changing technology. Acknowledging that company management is cultivating significant growth rates for Natesto® units sold and its prescriber base, investors have the right to feel confident that similar quantifying results for MiOXSYS® will get achieved. For those that are familiar with AYTU prowess, the latest MiOXSYS® territory approval is a welcome accomplishment, but at the same time expected. However, for those new to the story, it’s suggested that time gets spent learning about the management team and their proven track record of product development and market success.

Once aware of the team’s prior and developing accomplishments, as well as getting to know the accretive product portfolio beginning to make its presence known to the market channels, investors may be wise to consider purchasing shares at these low levels. After all, taking early advantage of AYTU’s future by realizing the potential from Aytu BioScience’s disruptive and revolutionary products may inevitably lead to long-term success, adding considerable shareholder value from AYTU finding its place as a leader in several multi-billion dollar markets.

Milestone Scientific MLSS Stock News

The biotechnology industry is one that is booming with innovation. Cures for some of the world’s most devastating illnesses have been and continue to be invented, new technologies are providing physicians with less invasive and more effective options for treating their patients, and breakthroughs in just about every aspect of the industry are taking place at what seems to be a breakneck pace. As a result, finding a corner of the biotechnology space that has little-to-no competition with a drastic need for innovation can be overwhelmingly difficult to say the least. Nonetheless, one company – Milestone Scientific Inc. (NYSEAMERICAN: MLSS) – has done just that.

An Introduction To MLSS

Founded in 1991, Milestone Scientific is a medical research and development company that’s focused on the industry surrounding subcutaneous drug delivery, which is the delivery of drugs under the skin. Interestingly, the hypodermic syringe was invented more than a century ago. In fact, the medical instrument has been around for more than 160 years. Nonetheless, little-to-no innovation has taken place surrounding this key medical tool since it was invented. This is where MLSS comes in.

When MLSS was founded, the company went on a mission to change what we know about the fear-inducing concept known as the hypodermic needle and syringe. A part of the medical industry that has not only led to fear in one-third of patients in the United States and around the world, but has also been starved of the innovation the medical industry had been seeing for years. Ultimately, Milestone Scientific wanted to find a way to relieve the pain, discomfort, and anxiety that comes along with this form of drug delivery.

In doing so, the company quickly learned that the hypodermic needle itself wasn’t the source of the pain that has caused this fear, discomfort, and anxiety. Instead, the source of this pain was the pressure created when the medication flowed through the needle and into the patient’s body. The syringe concept itself was the problem. In fact, as medicine flows through the broad diameter syringe and into the thin diameter hypodermic needle, enormous pressure is created. That pressure can be up to 300 PSI. Considering that most tires are only pumped to around 30 PSI, one could imagine the damage a drug being sent into the body at 300 PSI could do to tissue.

Enter The World Of Dynamic Pressure – Sensing Technology

Knowing that the hypodermic needle wasn’t the source of the pain, discomfort, and anxiety associated with subcutaneous drug delivery, but that pressure was, MLSS set out to solve the problem. This led to the invention of the company’s proprietary DPS® – dynamic pressure sensing – technology.

Through this technology, Milestone Scientific unlocked the key to largely pain-free subcutaneous drug delivery. By monitoring the pressure at which medicine flowed through the needle and into the patient’s body, MLSS was able to greatly reduce pain by reducing the flow of medication based on the pain-causing pressure associated with the treatment. However, this wasn’t the only benefit of the ability to sense pressure dynamically at the injection site.

In fact, through this pressure sensing technology, MLSS realized that they now had the ability to precisely place the needle where it needed to be in order to get the maximum effect of the treatment that was being delivered subcutaneously. Ultimately, the implications of this technology reached further than even the management at the company would have realized early on.

It All Started With The Wand®

With the information amassed through the creation of the DPS® technology, Milestone Scientific moved to the next step, inventing a tool for the dental industry that’s like no other. This tool is known as The Wand®. Taking advantage of the dynamic pressure sensing technology, The Wand® offers several benefits to clinicians and patients alike. These benefits include:

For Clinicians:

  • Single Tooth Anesthesia – Due to the unique ability of The Wand® to sense the pressure at the injection site, the tool allows clinicians to anesthetize a single tooth. The proprietary DPS® technology created by MLSS allows clinicians to place the needle in a very small area required to do so. In fact, that area is only about the width of a few of the same hypodermic needles that are used for the procedure. As a result, patients visiting the dentist no longer have to worry about a quarter of their mouth going numb when getting dental work done.
  • Reduction In Chair Time – At the end of the day, the longer a patient is in a dentist’s chair, the more opportunity for earning that dentist is missing out on and perhaps more importantly, the more anxiety takes place in the patient. Through the use of The Wand® by MLSS, patients spend less time in the chair, giving dentists the ability to earn more within their practice while reducing anxiety among patients.
  • Reduced Quantity Of Anesthetic – With the ability to anesthetize a single tooth, clinicians can now get the desired result with the use of a reduced amount of anesthetic.
  • Fewer Complications – With less pain for the patient as well as less numbing effects, dentists who take advantage of The Wand® see fewer complications when treating their patients.
  • Ergonomic Grip – The Wand® was designed by Milestone Scientific with an ergonomic grip, offering comfort to clinicians.
  • Reduced Patient Cancellations – Because The Wand® eliminates the pain associated with the injection of an anesthetic, fear and anxiety are reduced among patients, leading to less patient cancellations.
  • Avoidance Of Tachycardia – Through the use of The Wand®, clinicians now have the ability to avoid tachycardia, a serious, life threatening condition that is caused when drugs like anesthesia drugs that include the use of epinephrine are injected into the blood vessel. Because The Wand® uses the DPS® technology, dentists can be sure that the needle is not in a blood vessel, but instead, is in the target location for the treatment, avoiding the problem of tachycardia all together.

For Patients

  • Painless Injection – The Wand® by MLSS is designed to offer painless injections, bringing a new level of comfort to patients visiting the dentist.
  • No Collateral Numbness – Through the use of the DPS® technology, dentists now have the ability to anesthetize a single tooth, avoiding collateral numbness throughout the rest of the mouth and tongue.
  • Faster Onset Of Anesthesia – With the ability to target a single tooth with pinpoint precision, MLSS has created a way to speed up the process of anesthesia.

As a result of all of the benefits listed above, Milestone Scientific has seen great success surrounding The Wand®. In fact, the technology has received both FDA and CE marketing clearance, and more than 45,000 units have been sold leading to more than 70 million injections using the technology to date. In 2016, the company generated more than $10.5 million in sales from the product. This technology has also opened several doors for MLSS, as one would imagine.

First and foremost, MLSS has been awarded with 21 patents, many of which are wide-ranging, surrounding its proprietary DPS® technology. On top of that, it has seen favorable evaluations in more than 50 peer-reviewed independent clinical research reports. Not to mention what is perhaps the largest validation of their work to date, the company has entered into an agreement with Henry Schein.

MLSS Enters Agreement With Henry Schein

Recently, Milestone Scientific reached a substantial milestone when they announced that they had entered into an agreement with Henry Schein. The recently announced 10-year exclusive distribution agreement signed with the world’s largest provider of dental products opens several doors for the company.

First and foremost, Henry Schein has dedicated 25 sales representatives to the product, and they are supported by 900 field representatives. Henry Schein has also agreed to minimum purchase orders in order to maintain exclusivity through the 10-year period. Through this relationship, MLSS plans to ship approximately 2,800,000 disposables in 2017, which represents about 4% market penetration in a market where about 150,000 dentists perform more than 75 million injections annually.

Revenue Growth

As if the product offering wasn’t enough to get excited about, MLSS has seen some impressive revenue growth on a year-over-year basis throughout the past 3 years. The chart below shows the exceptional revenue growth the company has seen. In the year 2015, the company generated $4.5 million in revenue, followed by $5.8 million in 2016, and $6.2 million in 2017. With the Henry Schein partnership, the potential for future revenue growth is incredible!

Looking Into The Future

When looking into MLSS at the moment, you’re going to see quite a bit about The Wand® and its use in the dental industry. However, the implications of the DPS® technology go far and wide. In fact, Milestone Scientific received CE marketing approval for instruments in both the intra-articular and epidural spaces. In the United States market, the company has received FDA clearance for the CompuFlo epidural instrument and is currently working toward FDA clearance for the intra-articular instrument. In fact, MLSS is currently in negotiations with regard to forming strategic distribution partnerships around the world surrounding these applications.

This doesn’t even go into mentioning the pediatric, cosmetic, veterinary, and many other applications that MLSS is in the process of tackling with their unique technology. In fact, the company is well on their way in some of these applications:

  • Ophthalmic Injections – At the moment, the Milestone product pipeline includes a proposed plan to develop an Ophthalmic Instrument in the future. MLSS plans on designing this instrument to address several key needs associated with ophthalmic injections, including wet AMD, diabetic macular edema, and retinal vein occlusions. Through the use of their proprietary DPS® technology, the instrument would provide a virtually painless injection while simultaneously controlling the injection pressure to ensure a safe and effective pressure level during an intro-ocular administration.
  • Pediatric Applications – Currently, MLSS products are being used in various pediatric applications. In particular, The Wand® system is being used with great success in pediatric dentistry, as it improves the patients overall experience and decreases fear. Also, due to the ability to pinpoint anesthetic to a single tooth, children don’t inadvertently bite themselves after a dental operation. The pediatric community as also benefiting greatly from Milestone’s CompuFlo epidural. In fact, two key opinion leaders in the field of pediatric anesthesia have approached MLSS to initiate clinical research using the company’s CompuFlo technology for epidurals in children. While this process is relatively young, the company intends to support any such research and will be able to report the results and findings in the future.
  • Veterinarian Applications – Finally, even the veterinary industry can benefit from Milestone Scientific’s proprietary DPS® technology. In fact, Dr. Louis Campoy has completed multiple studies at Cornell College. During the studies, Dr. Louis Campoy used the CompuFlo technology to perform the Maxillary Foramen Block in a horse. To read the studies, click here (This will be a live link upon publication).

DPS® Technology Targets A Potentially Massive Industry

When looking into the potential of the DPS® among all currently approved applications and applications under development, it becomes clear that MLSS is addressing a massive market. Just take a look at the number of injections that take place in the United States market alone, generating an industry worth more than $1 billion per year:

  • Epidural – Between labor and delivery, preoperative pain management, and chronic pain, 12.8 million epidurals are performed every year in the United States alone.
  • Peripheral Nerve Block – 9 million peripheral nerve block injections are performed in the United States every year.
  • Intra-articular – 5 million intra-articular injections in the knees, shoulders, hips, and other joints of the body take place in the United States every year.
  • Cosmetic – 8.4 million Botox injections are performed in the United States every year.

DPS® Is The Key Driver Of Value

In this article, we’ve discussed quite a bit surrounding the dental applications as well as the epidural, intra-articular, and other applications of this technology. However, these applications, even when combined, aren’t the biggest value proposition associated with this technology. The reality is that the technology MLSS has created has the ability to become a disruptive force in both the drug delivery industry and the intellectual property protection industry. Here’s how…

Drug Delivery

We are already seeing how DPS® can change the shape of drug delivery in dental and other applications. While the dental applications are building revenue right now, the opportunities down the road are endless, and Milestone Scientific knows it. The company has an ultimate goal of creating hundreds of various medical devices designed for different types of injections, and they are well on their way to doing so. With the ability to detect exactly where the needle is in the human body through the use of pressure feedback, there is an abundant need industry-wide for a tool like this.

There are hundreds – and potentially thousands – of uses for a tool like this in the medical industry, and the industry needs a solution. On the industry side of things, about 4.5% of epidural injections end in morbidity. This means that the needle has passed the target, touching the membrane surrounding the spinal column. Every time this happens, another anesthesiologist has to perform another epidural and close the hole created with a blood patch. This can leave the patient with severe migraine headaches for up to 6 weeks, transient paralysis for up to 2 years, or even permanent paralysis. The cost of these issues is massive. In fact, the average settlement in an epidural morbidity case costs the facility around $400,000, not to mention the cost of the additional procedure and the cost of the original doctor not being able to work on the patient. With CompuFlo by MLSS, more than 700 epidurals have been performed with a 100% success rate due to the use of the company’s DPS® technology. This is just one corner of the vast market.

However, the company isn’t stopping with the injections themselves. Another thing to keep in mind here is that, with every device created, MLSS also sells disposables designed to work with that device. Ultimately, these disposables will create a constant stream of revenue beyond the purchase of the medical instruments themselves.

Patent Protection

Patents expire all the time in the medical industry; it’s the nature of the beast. When this happens, the company with the brand name drug loses the vast majority of the market to generic competition. However, Milestone Scientific has a solution for this problem as well.

The company intends to partner with the companies that have created drugs with patent expiration. Through these partnerships, MLSS plans to create medical devices designed around the out-of-patent treatments. Of course, the new devices will only use the brand name drug, giving the pharmaceutical company a leg up in the market once its patent expires. From there, MLSS could license the technology, wholesale the device to the company, or even sell the rights to the device to the company they partnered with.

The Bottom Line

Milestone Scientific is a company that is well worth watching. As the company’s Wand Dental subsidiary continues to grow profitability, the company continues to innovate and expand their offering, proving that their product and business model works. With proprietary disposables that provide high margins and continued innovation in new and exciting products surrounding the massive subcutaneous drug delivery market, MLSS is becoming hard to ignore. As revenue continues to grow, the company is expecting continued expansion in operating margins thanks to a highly scalable business model. Moving forward, the CNA Finance team will be watching for continued growth in The Wand® revenue, continued innovation in the subcutaneous drug delivery industry, and expected catalysts including operating results, study publications, and distribution contracts, all of which are expected to come down the wire relatively soon. We’ll continue to follow the story closely and bring the news to you as it breaks!

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. Worldwide Holdings paid CNA Finance $2,500 for research and writing services as well as other investor relations services provided to Milestone Scientific by CNA Finance. All information researched and provided through any article associated with Milestone Scientific 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.

Aytu Bioscience Inc AYTU Stock News

Many people follow the age-old adage to forget half of what you read and most of what you hear. And, no matter what side of that spectrum that you reside on, there can be little dispute that the media will report on stories that best fit their customer demographic. Well, likewise – when it comes to financial news, the reporting and analyst coverage gets similarly presented with bias, arrogance and deliberate misleading attempts to distort the truth behind the real momentum or lack of from a particular stock. And, in some cases, promising companies get overlooked despite the fact that many of their financial backers are well aware of the company promise.

Take Aytu BioScience (NasdaqCM: AYTU), for instance. Here sits a company that is most likely the best positioned to take advantage of the continued growth in several lucrative markets- testosterone replacement therapy, male infertility, and female sexual dysfunction. Each market, in their own right, offers substantial revenue opportunity to Aytu BioScience, with the TRT market expected to generate beyond $2 billion in the next year alone. Then, add in the combined potentials from the estimated $4.7 billion male infertility market and the projected $9 billion from the female sexual wellness market, and AYTU, at current price levels may easily be one of the most undervalued biotech stocks in the sector. Beyond the multi-billion dollar market potential, though, when the value of having three products already on the market gets added into the equation, the AYTU market cap at current levels is almost comical.

Breaking Open The Value Proposition

The primary revenue driver in the near term is the company’s TRT product, Natesto®, which has posted impressive cumulative growth during the year. Evidence of the product’s ability to penetrate the lucrative market is supported by AYTU’s announcement two weeks sgo that this TRT product has again recorded record prescriptions and sales, adding to its recent nine-month stretch of all-time high prescription and revenue run rates. But, despite the record sales and product driven momentum, the AYTU share price has declined by over 30% since the final week of October, leaving many investors scratching their heads as to why the lack of respect.

On the surface, investors may believe that there is a lack of confidence in the portfolio potential. However, for savvy investors that look beyond the headlines and keep apprised of SEC filings, the real story for the recent weakness emerges, and it provide be a brief opportunity for investors to grab shares at current price levels. To those investors that understand the intricacies of the public markets, especially in regard to financing, they acknowledge that the recent decline in share price may have far more to do with those short-sighted, profit-minded institutional investors than it does about the promise of the company.

Reviewing AYTU’s most recent SEC filings, notably the S-1, the current price weakness may be the result of the company’s ascent into the NASDAQ Capital Markets. Sure, such a contradictory premise presents quite the paradox, primarily when the move to the NASDAQ market was a significant catalyst for AYTU. However, by reading between the lines, it becomes relatively apparent that share price weakness may have been inevitable, primarily caused by those same institutional promoters that made the most important move in the company’s history possible. But, by understanding the short-term effect that is likely playing itself out, investors may be wise to look closely at this investment opportunity. After all, instead of remaining a bystander to the actions of those that bought low and are selling high, investors can instead take advantage of the market at hand and potentially profit handsomely from the situation. Thus, for investors who feel as though they are caught in a downward trend on the AYTU trade, they need to think again.

In fact, now that these short-term institutional partners have apparently sold off a good portion of their cheaply acquired shares that are now registered and freely trading, AYTU might again be positioned to resume the share price momentum experienced while riding the appreciable wave from securing an up-listing to a major trading exchange. And, with that single catalyst alone, the opportunities are strengthened significantly for AYTU, taking advantage of institutional coverage, mainstream financing options, and a departure from the wild-west trading patterns of the OTCBB markets. Beyond just the upgrade, though, AYTU can again rise on merit-based momentum and consistent product penetration. Here’s how:

Natesto® Has No “Black Box” Warning

The testosterone replacement market is huge and very few investors, if any, are willing to make a case that the size of the market will shrink anytime soon. To the contrary, the current and estimated $2 billion TRT market is starting to look like it has the legs to reach significantly higher levels. And, with Natesto® generating robust growth, primarily driven by the product’s best-in-class results, the future for AYTU stands bright, highlighted by the emerging visibility of multiple pipeline products that are each capitalizing upon the strategic market and sales growth opportunity.

Focusing on Natesto®, the benefits can deliver near-term value. And, with the product being already FDA approved and available for sale, it provides AYTU with the most aggressive path forward to secure meaningful revenue, with the anticipation that the product will lead the company to near-term cash breakeven or potential EPS levels in the coming months. The FDA, if it followed its mandate, could make the path even more lucrative for the company by stepping in and reviewing the competitive landscape in the TRT market. If they did, the growth for Natesto® could be enormous from the effects of the FDA restricting sales of several TRT products that bring with them serious and adverse side effects. But, until the FDA acts responsibly, Natesto® will need to capture the market organically.

It makes one wonder, then, that since Natesto® is the ONLY topical testosterone replacement therapy on the market that DOES NOT have the most serious FDA mandated Black Box warning on its label, then why isn’t the FDA putting a moratorium on sales of Natesto®’s competitive products? After all, Natesto® is a safe and alternative option, proven both safe and beneficial to patients. Natesto® is clinically shown to provide best-in-class results when compared to most every competitive TRT product available in the market. Comparisons to FDA-approved products like AndroGel® and Axiron®, demonstrate in no uncertain terms that Natesto® is just as good, or better, in providing sustained patient benefit without the need to risk serious health consequences. The potential detriment from other products is no secret. If investors looked at the lawsuits piling up against AbbVie and Eli Lilly, patients would understand that they are unnecessarily playing with fire when an entirely safe and alternative product is already available. Ultimately, though, it’s up to the prescribing physicians to keep abreast of the newest developments in the field, and stop turning a blind eye to the potentially harmful effects of the drugs they are prescribing to their patients.

Even if physicians paid closer attention to the alternatives, investors should remain patient and understand that the growth in Natesto® prescription rates is rising sharply despite the far lower marketing budgets and much smaller sales force. Regardless of the more moderate marketing budgets, the impressive growth in both new prescription levels and revenue run rates is not slowing down. According to the most recent sales data reported in late October, Natesto® sales have again reached all-time highs, increasing double-digit percentages between September and October alone. For the year, the spike in Natesto® orders is more impressive with compound growth rates rising by more than 70%. And, sales are spiking because of the known benefit and safety from Natesto®, which is proven to be a superior choice in treating and improving erectile dysfunction on all five of the measured domains. Beyond the efficacy demonstrated in the erectile dysfunction front, Natesto® also shows dramatic and sustainable improvement in the desire for sexual activity beginning in as little as thirty days from initial use.

The Multi-Billion Dollar Opportunity

Classified as the only nasally administered testosterone replacement therapy, the safety and efficacy profile for Natesto® is remarkable. In clinical trials, approximately 91% of patients were reported to have normal testosterone levels within ninety days of starting treatment. Substantiating those results, clinical trial patients that were part of the twice-daily dosing also reported reaching normal levels within the ninety-day window as well. But, while being nasally administered may be convenient, it is also proven to be a critically important aspect in limiting the exposure of accidental and unintentional dosing of testosterone to women and children, a concern raised by a significant portion of the user population of competing products.

Natesto® is serving a $2 billion market. And, rather than have ambitions of grandeur to conquer the entire market in one fell swoop, AYTU management appears more than willing to focus slowly and methodically on securing perhaps 10% of the potential market in the next several years. If they are successful in doing so, the rewards will be staggering. Assuming the market opportunity sits at $2 billion, AYTU can bring in over $200 million in revenue. Apply that revenue to the small O/S count of fewer than five million shares, and investors can expect an explosion in the market cap multiple. If such a case transpires, AYTU may benefit from similar peer multiples, potentially powering the share price to return to levels exceeding $17.00 per share, pre-split levels seen earlier in the year.

For those that are following the story, the market battle lines are drawn, and AYTU is executing well on their strategy. The company showed investors an increase in Factory Sales Units of over 300% between the Q2 and Q4 in the company’s fiscal year 2017, providing substance behind the claim that Natesto® is on its way to securing a respecting market position. To put that sales number in unit terms, real product demand and production show an increase in sales and orders from 1,764 units sold in Q3 of 2017 to 4,248 units produced for sale by the end of the company’s 2017 fiscal year, an over 140% gain over the prior quarter alone. Thus, AYTU management is delivering on their goals, and as the actual numbers continue to replace the estimates, the news of record sales and prescription volume provides the real impetus for why investors should consider getting in front of the AYTU trade.

Capitalizing On The Aytu Catalysts

The current market cap of roughly $14 million borders on being comical for a company that has three products commercially available and essentially de-risked from regulatory approval uncertainties. And, with only 4.2 million shares currently outstanding, Aytu has capital leverage and availability to add to their strategic acquisition geared portfolio that has been successful in bringing into the company pipeline three other drug and treatment candidates also positioned to deliver explosive revenue growth in the next few quarters and years.

The elements of success are in place for AYTU, and the product portfolio is fortified with growth-oriented potential that delivers best-in-class market value to patients looking for an alternative treatment product that is safe and effective for daily use. Yes, the markets are volatile, and AYTU has been in the cross-hairs of being in-between a market uplisting and the sale of cheaply acquired shares by early investors. The AYTU insiders, though, are not selling shares, which is a critical indicator that their belief in the growth of the company is only in the first inning of a much longer market game. Investors should act with interest and take a look at the investment proposition presented by AYTU, recognizing strong sales growth, a portfolio of disruptive products, and a balance sheet that has been fortified with sustainable cash balances expected to last into breakeven or EPS status as a reason for investment consideration.

An investment into AYTU at these levels is more de-risked than ever, and once the S-1 sellers move on, expectations should be set for a sharp and quick move to the upside, to levels that can quickly double, triple, or even quadruple from current share price levels.

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. Aytu Bioscience pays CNA Finance $4,000 per month 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.

AIT Therapeutics AITB Stock News

Investors, if you have not yet met AIT Therapeutics (AITB), consider yourself privileged to be provided an introduction. Now, although that prior statement may read as presumptuous, once investors get initiated to the premise that AITB sits ideally positioned to alter the therapeutic landscape for treating respiratory infection and pulmonary hypertension, the favorable opinion is undoubtedly substantiated.

In fact, not only is AITB on its way to becoming a potential market disruptor, undertaking aggressive steps to bring to market a revolutionary platform of Nitric Oxide treatment, but they are also doing it in a manner that may ultimately secure a dominant and leading position in how, and in what amounts, Nitric Oxide may be used to treat several debilitating infections and disease indications.

Nitric Oxide May Be A Seriously Valuable Compound

Before jumping into the absolute specifics of AITB, it’s important first to highlight the significance of utilizing Nitric Oxide (NO) to treat a specific disease and bacterial infections. Nitric Oxide is a chemical compound produced naturally by cells within the body which work to help relax vascular smooth muscles, which when functioning correctly promotes vasodilation, or the widening of blood vessels. Today, Nitric Oxide is commonly used medicinally in newborn babies who have trouble breathing, working by reducing pulmonary vascular pressure and improving the baby’s ability to breathe efficiently. Nitric Oxide is also notable for its potent antibacterial properties and high cell penetrability, which has made the compound the subject of numerous studies to prove its value for treating acute and chronic lung infections. NO inhalation therapy, itself, has earned significant interest within the last decade as a non-antibiotic method of treating lower respiratory tract infections, specifically nontuberculous mycobacteria (NTM) and Bronchiolitis. Although inhalation therapy is still undergoing collective research, published clinical results indicate that the benefits from a proven and effective NO regimen could be revolutionary in how many disease and infection-based illnesses get treated. While it is widely acknowledged that inhalation of Nitric Oxide can be harmful outside of a medical setting, the FDA is looking beyond intentional abuse and recognizes the compounds value, supported by a favorable safety profile shown to have little to no side effects when used under the proper precautions and medical supervision. This positive view by the regulatory agencies may ultimately allow AITB to circumvent extensive and financially burdensome studies on long-term safety potentially.

That’s all good for AIT Therapeutics. In 2011, AITB proved successful in developing a novel and proprietary technology that could safely deliver NO gas to patients via inhalation. The technique is a considerable achievement, and the efficacy of NO therapy has already demonstrated the potential to provide superior therapeutic results compared to traditional standard of care treatments. Currently, the AIT device is uniquely designed to safely deliver NO to the patient at a concentration of 160 ppm (parts per million). This ratio is a notable improvement over similar therapeutic options on the market, such as Ikaria’s Nitric Oxide device, which is limited to a maximum of 80 ppm in intubated patients. AITB’s contribution, on the other hand, allows for not only a safe treatment, but also provides a substantially higher level of delivery intensity from its patent-pending three gas combination that does not need patient intubation. With this clinically proven technology strengthening the cause for further research, AITB is continuing their progress through validating clinical studies to determine the optimal rate and method of NO transmission to the patient. As of 2016, the company has completed four trials to analyze both the safety and efficacy of their inhaled NO therapy in patients with Bronchiolitis, cystic fibrosis, or NTM. In all four studies, no serious adverse events (SAE) were observed in any of the patients treated, and as of the latest 2016 trial, a clinically significant reduction in bacterial load was observed in NTM patients, suggesting a strong likelihood that future results may continue to show clinical promise. And, if those results prove to be statistically significant, AITB may be set on an expedited path for FDA and EMEA approval and will be apt to become one of the primary breakthrough leaders in this revolutionary field of treatment.

AITB Puts Nitric Oxide to Work

AITB has dedicated the majority of their research toward the use of inhaled NO therapy as a safer and more beneficial alternative to traditional treatments for patients with certain types of lung infections and pulmonary hypertension. The company is now targeting mycobacterium abscessus complex, or MABSC, which is recognized as one of the most aggressive and difficult to treat conditions caused by NTM, and is only one of over 150 identified species of NTM that most often infects subjects through inhalation from the environment. Patients with underlying lung disease, such as cystic fibrosis or COPD, or a weakened immune system are at higher risk of acquiring the condition. In 2014, there were an estimated 180,000 new cases of NTM in the United States, with over 20% of these cases being MABSC. Another manifestation of the disease, NTM mycobacterium avium complex (NTM MAC), is also being targeted by AITB. Patients with MAC have a median survival rate of 13 years, and this number gets reduced to only 4.6 years in patients with non-MAC NTM (essentially MABSC), so it is crucial that a safe and effective treatment be developed and implemented to prevent or stifle this fatal disease. Despite the relative surge in the development interest of inhaled NO therapy, there exist only a few companies working in the NTM space, and competitively favorable to AITB, there is currently little to no competition in the MABSC space, creating a generous opportunity for AITB to capitalize on that lucrative market.

AITB is now progressing through clinical studies of their proprietary NO inhalation therapy in cystic fibrosis patients with MABSC, and is reporting promising interim results. In one study, two patients were treated with a regimen designed to fit the specifics of their disease indication, and in both patients, MABSC values notably decreased during and after AITB’s inhalation-delivered NO treatment. Before the AITB treatment, both patients received prior care with current standard of care drugs, which is a cocktail of antibiotics known to cause undesirable side effects including blindness, deafness, liver damage, gastrointestinal disturbance, hypersensitivity, and more. Complimenting AITB’s Nitric Oxide treatment, however, the study patients experienced no adverse events and were benefited from a significantly reduced load of mycobacterium abscessus. In fact, Patient 2 was determined to be mycobacterium abscessus negative by culture 20 months after the initial eradication with Nitric Oxide treatment. Encouraged by these favorable results, AITB has completed dosing of nine more patients infected with MABSC and is waiting for the data to mature before informing investors prior to the end of this year. The study points for the trial will continue to observe the safety profile and efficacy data from the NO treatment and will scrutinize data to pinpoint the optimal concentration of NO inhalation levels. Again, it is important to note that no other company currently has the technology to replicate the method and delivery properties utilized by AITB, and with interim results demonstrating promising value, AITB is in an enviable position to advance its platform to become a leading provider for treating most all NTM related diseases.

Another Focus Is On Bronchiolitis

Not only has AITB produced promising results in NTM, but they have also reported encouraging results from their Phase 2 trial in treating Bronchiolitis with Nitric Oxide therapy. Bronchiolitis is a lower respiratory tract infection that occurs commonly in infants or the elderly, with over 400,000 hospitalizations per year in the United States alone. Important to note, there are currently no drugs approved to treat Bronchiolitis, limiting hospitals and treatment centers in their ability to assist patients by providing only a steady supply of oxygen and hydration. Sadly, while the total United States market size for a Bronchiolitis treatment is estimated to eclipse $2 billion, there existed no meaningful options available to patients that offered a new and effective treatment – that is, until AITB stepped in.

Understanding that their inhaled NO technology could be a perfect candidate to meet both patient and market needs, the company designed and recently completed their Phase 2 clinical trial in treating Bronchiolitis. And, like their studies with NTM, the early results have proved promising. In a double-blind study, 21 Bronchiolitis patients were placed on a regimen of NO therapy for five days, while another 22 Bronchiolitis patients were treated with only the current standard of care of oxygen and hydration. At the end of the study, the amount of time necessary to reach acceptable oxygen levels was found to be 80% faster with inhaled NO therapy relative to the standard treatment. Additionally, the mean time to oxygenation was only 35 hours in the NO group, while the standard control cohort averaged 63 hours. What’s more, is that this expedited rate of recovery shortened the hospital stay of the NO-treated patients by one day – a 34% decrease in hospitalization time compared to the patients treated with standardized care. Also, similar to the results from the NTM testing, patients experienced no significant adverse effects when treated with NO. Translating those findings, they may indicate that AITB’s NO therapy has considerable advantages over the current standard of care in treating Bronchiolitis. And, with no other company aggressively exploring or competing in the full Bronchiolitis space, AITB is positioned ideally to capitalize on the recognition, market need, and associated revenue of bringing a viable and valuable treatment to Bronchiolitis patients worldwide.

AITB Is A Forward Thinking, Market Disruptor

Here’s where it gets interesting for investors. Not only is AITB perpetuating its potentially revolutionary technology, but the company remains active toward expanding upon their proprietary foundation through accretive acquisitions to further improve and broaden their existing technology and market reach. On November 1, AITB announced it would be acquiring an exclusive license to the eNOGenerator and certain assets from NitricGen, Inc. The acquisition is a potentially massive deal for AITB on several levels, because, with the eNOGenerator incorporated into the AIT NO delivery system, the company is now able to provide the same therapy at an even more efficient, customizable, and cost-effective rate than before. The eNOGenerator ensures the ability to generate NO on demand and deliver it to the lungs at a precise and desired concentration, with a range of 1 ppm to 400 ppm. AITB has previously focused on providing NO at 160 ppm, and adding this innovative technology will allow them to quickly adjust their treatment for indications that may require a different concentration of NO. Next, the acquired device’s ability to generate NO on demand eliminates the need for the sizable and high-pressure NO cylinders used in the hospital setting, replacing cumbersome systems with the new AITB generator weighing only 7 pounds. Not only does the reduced scale remove the need for hospitals to acquire additional supporting resources, but it also allows users to receive active treatment within a household setting. Finally, along with the eNOGenerator and the included assets, the agreement also brings two experienced executives to the AITB team, Fred Montgomery and Duncan Bathe. Montgomery and Bathe combine for well over 24 years of experience in researching and developing NO delivery technology, and respectively hold over 30 patents in the NO delivery system space, including the eNOGenerator purchased by AITB. Now able to reap the advantages from this added expertise and industry experience, AITB’s mission of improving and replacing the many outdated and inefficient standards of care with their novel method of inhaled NO therapy gets strengthened significantly.

In addition to their acquisition of the eNOGenerator, AITB also has secured many patents of their own, with 19 currently issued patents and over 20 patent applications in process. The company has been awarded patents for both their method and delivery processes of inhaled NO to treat various illnesses, and combined with their recent acquisition, AITB aims to expand upon these current patents to Bronchiolitis and their technological scope and improve upon their already successful treatments. In addition to ongoing studies, AITB is increasing focus to include the use of NO to treat inflammatory airway disease and to potentiate antibiotic therapies. AITB plans to advance through Phase 2/3 clinical trials to target and treat Bronchiolitis and NTM throughout the next few years and is planning to begin studies targeting the NO treatment of Chronic Obstructive Pulmonary Disease, wound healing, and pulmonary hypertension within the next two years. As of November 2, AITB is sitting at $4.96 per share, with 6.04 million shares outstanding and a market cap of $30.22 million. The company has no debt and is likely to secure additional funding for their pivotal U.S. clinical trials in 2018.

Disruption Is Good, And So Is AITB

Overall, investors would be smart to consider a serious look into the potential offered by AITB. Clinical trials have shown the company’s technology to substantially improve upon the current standards of care in virtually every respect, and without the adverse side effects brought on by more traditional treatments. There is little to no competition in the markets targeted by AITB, and if their platform proves to be the breakthrough technology it is shaping up to be, the company would undoubtedly have a probable chance at becoming the clear service provider in the industry. Led by a team of experienced professionals with a vision of improving care for those who need it most, AITB deserves the consideration of any investor looking for an emerging company with a strong clinical foundation and market disruptive technology.

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. Worldwide Holdings paid CNA Finance $2,500 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to AIT Therapeutics by CNA Finance. All information researched and provided through any article associated with AIT Therapeutics 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.

Aytu Bioscience Inc AYTU Stock News

For those who doubted the value and need for an alternative testosterone replacement therapy product, investors in Antares Pharma were stunned into certainty as they saw over $210 million in market cap evaporate in front of their eyes. The share price devastation came on the news that the FDA said, of Xyosted, that there are “deficiencies that preclude the continuation of the discussion of labeling and post-marketing requirements/commitments at this time.” In other words, Xyosted appears to be DOA.

And, while the news may be a shock in the wallet to ATRS investors, the prime beneficiary to the apparent Xyosted rejection very well may be Aytu BioScience.

What Happened To Antares Pharma?

To be clear, the FDA review of Xyosted is not expected to be concluded until October 20, leaving investors with a short wait to find out the specific details as to why the FDA sent such a disheartening letter. However, investors appear to see the writing on the wall, and the stampede to the shareholder exits has started, with shares of ATRS declining by more than 37% on Friday on volume that spiked to almost 10X its daily average.

Although the news for ATRS may be a significant blow to the future of its once-promising TRT drug, the report may explain the sudden interest in Aytu BioScience shares during the previous three sessions, with shares rising over 15% in value. And, if the $210 million haircut to the ATRS market cap serves as a valuation metric, AYTU shares may have significantly more to run. In fact, if investors wanted to be presumptuous, as they can often be, the perceived value lost in ATRS’s Xyosted would equate to over $50 in share price to AYTU. That may sound extraordinary, but with only about 4.1 million shares outstanding, AYTU’s Natesto® may be the prime beneficiary to Antares’s woes and reap the rewards from investors bailing on Antares, but not in the TRT market opportunity for Natesto®.

And, here’s why.

Aytu BioScience’s Natesto® Set To Emerge?

Now that investors had the first taste of just how vital an alternative TRT product may be to the market, the value in AYTU’s approved for market Natesto® may now be positioned to emerge as a potential leader in the space. Not only is Natesto® already FDA approved, with new prescription rates rising sequentially over the previous nine months, but it is also the only TRT product available on the market that does not have an FDA mandated Black Box warning label.

Not only should Natesto® be considered the safest TRT product on the market, but it is also the only nasally administered treatment available, which in and of itself offers significant dosing, safety, and convenience benefits to its users. Beyond the safety, however, Natesto® has shown efficacy results that are potentially best-in-class, with clinical data showing that the product provides substantial benefit to over 90% of patients with measurable results in less than thirty days of Natesto® use.

Benefits of Natesto® have been proven to provide a significant and sustained effect in treating all domains of erectile dysfunction, requires no special diet, has no injection site pain, and importantly does not lower the natural production of necessary hormones, LH and FSH. But, even with the known benefits and the company reporting over 300% in new prescription rate growth, there is another essential factor to consider: the lucrative market potential.

Natesto® Can Take Share From Big Pharma

Aytu BioScience is positioning Natesto® to compete against the Big Pharma products, inclusive of AndroGel®, Axiron®, and Fortesta® each of which has Black Box warnings on their labels. Targeting the $2 billion TRT market, and with the apparent FDA rejection of Xyosted, Natesto® may attract significant attention. And, with efficacy results as good as or better than the products mentioned above, there should very well be a spike in interest in the potential for AYTU to successfully gain market share and physician attention.

Assuming that Natesto® can grab just 5% of the market, though, the results may have a tremendous impact on the company’s valuation, resulting in potential revenues that surpass $100 million for Natesto® sales alone. And, when compared to current TRT market leaders like AndroGel®, Axiron®, and Fortesta®, the benefits of Natesto® get magnified. For instance, topical TRT products, such as AndroGel®, Axiron®, and Fortesta®, each have the dangers of an accidental transmission of the product to women or children. And, users of these medications must physically “quarantine” themselves during the application process, attempting to reduce the risk of accidentally dosing their wives or children through physical contact.

Further, while physicians and users may have been looking forward to an approved Xyosted, which may have excluded Black Box labeling, the attention to TRT safety and efficacy must again be turned elsewhere. The three times daily nasally administered Natesto® may provide the solution, differing itself from all long-acting gel preparations and injections that are shown to cause increased hematocrit levels in the patient. The rise in hematocrit levels is quite dangerous, by the way, creating thicker blood within the user’s body and significantly enhancing the risk of stroke. To compensate for the dangers, patients often need to lower their dosage or even quit their TRT medication. In extreme cases, patients have turned to donating blood more frequently to thin it out, which is not exactly an easy solution to the problem at hand.

Thus, it should not be understated that, Natesto®, in clinical studies, has been shown to have virtually no effect on hematocrit levels. This benefit eliminates the potential roadblocks faced by other medications, and once again shows how Natesto® is quickly becoming the best choice among TRT options.

Where AYTU Goes From Here

The available market for Natesto® is significant, and with the unexpected and likely FDA rejection of Xyosted, the product is positioned to attract considerable physician attention. Vital to the growth, Natesto® has established an increase in insurance reimbursement coverage, has deployed an aggressive sales force to penetrate the TRT markets, and has secured the capital to sustain its marketing and educational programs to drive prescription growth.

Investors in the know may already be turning their attention toward AYTU, accounting for the recent 15% spike in share price. But, taking into account that ATRS saw over $200 million scalped from its market cap, AYTU may have significantly more value to absorb. If Natesto® was an inferior product that only offered safety benefit, investors might have cause to doubt the potential of Natesto® However, that’s not the case.

Natesto® is as good, or better than most treatments on the market, and at the same time is the ONLY testosterone replacement therapy product on the market that does not have the Black Box warning. And, after completing an $11.8 million private placement earlier this year, AYTU is well funded to educate prescribers and users to the benefits of Natesto®. Thus, for investors that are rotating out of ATRS and looking to invest in a TRT product that is both FDA approved and available to the market, AYTU may offer the opportunity they are looking to exploit. With roughly four million shares outstanding, a healthy balance sheet, and a product that may prove to be best-in-class, AYTU’s Natesto® may very well earn a substantial portion of the available TRT market.

One thing may be certain. When investors do realize the potential that both Aytu BioScience and Natesto® have to offer, the low share count and tight liquidity features of the stock may drive shares much higher, and at a rate far faster than many expect. Now that Natesto® may become a favored TRT product, and with AYTU having the financial means to perpetuate an aggressive sales strategy, considering an investment in AYTU now may prove to be advantageous to an investors economic health.

Ascent Solar ASTI Stock News

The solar industry is the home to some of today’s most innovative and cutting-edge technology, and as time goes on, newer and more efficient advancements continue to revolutionize the market space. The evolution of the sector makes the solar industry a potentially lucrative field for investors to capitalize upon, and several unique opportunities are waiting to be seized by both investor and company, alike. One of these intriguing investment opportunities points straight to Ascent Solar.

Ascent Solar (ASTI), a business rooted back to 2005, is intent on bringing its breakthrough photovoltaic technology to the solar market spotlight. Notably, and to the testament of ASTI’s focus, industry experts recognize this technology as a potential leading application for the solar industry, placing ASTI in a favorable position to take advantage of their developed technology and become a leader in the evolution within the solar market.

CIGS Technology Is The Difference

Ascent Solar is focused on the development and promotion of their cutting-edge CIGS (Copper, indium, gallium, selenide) photovoltaic technology on flexible, plastic substrate. These panels are designed to convert sunlight into electric power by laying a thin layer of the elements above onto a plastic backing. And, as a leader in the CIGS field, Ascent is the only manufacturer in the world commercially producing CIGS solar on a plastic substrate with monolithic-integration, a key differentiator that sets them ahead of the pack for selected sector use.

Through the utilization of CIGS cells, the solar modules designed by Ascent allow for maximum efficiency and durability while minimizing weight load – a combination that has the potential to revolutionize the ways solar panels can get utilized in everyday applications. Because CIGS has a higher sunlight absorption coefficient than other semiconductor materials, a much thinner layer of film is needed for the panel to function, allowing for the use of a flexible plastic substrate. In effect, this gives the technology the best power-to-weight ratio relative to its competitors, which opens up the possibility of use in situations where weight is a significant constraint. For example, the high-voltage, low current module makes the technology suitable for both space and aerospace travel, and ASTI has focused a particular emphasis toward the drone industry, where ASTI believes a substantial opportunity is in play.

 

 

While competitors continue to focus on residential and industrial solar ambitions, ASTI has dedicated their research and development to improve advanced CIGS technology further and capitalize on its potential uses. More specifically, the flexible and modular applications of ASTI’s technology allow for Ascent to target specialty and high-value markets that are unable to make use of traditional solar panel solutions. These advantages create a significant opportunity for ASTI for two reasons. First, the company faces much less competition from standard solar power companies, whose products lack the functionality and durability of the ASTI product.

Second, facing an industry that is more attentive to function over cost, ASTI has been taking steps in recent years to develop both their products and their business model to best meet the needs of emerging industries reliant on innovative solar energy products that must meet selected and product specific requirements.

Niche Focused Toward Drone/UAV, Space, And Military Applications

In the face of a highly saturated solar market, ASTI has placed their focus on innovative and specialized products that can fulfill the more specific needs of niche markets. As the cost and availability of fossil fuels continue to be volatile, industries are being pushed to find a more modern and reliable replacement. The military, government, public sector, and disaster relief markets are all examples of markets that are actively looking for lightweight and dependable solar technology that can withstand rugged environments and rough handling. Currently, these sectors are often forced to use heavy and bulky batteries to fuel essential devices, and ASTI believes their lightweight solar technology is the perfect solution to solve this ongoing issue. For instance, batteries have been shown to be the third heaviest item a soldier must transport, behind the other essentials of water and fuel. Instead of heavy and bulky batteries, ASTI’s solar technology provides a superior option that serves as a portable and rugged solution that allows the military to efficiently power and charge various devices.

The company has also emphasized its focus on the disaster relief market, which is expected to offer significant opportunity for ASTI’s products to impact that market with unique applications.Secondarily, the benefits from the CIGS technology brings the ability to deliver portable, durable and naturally powered energy to consumers and rescue teams, where ASTI can enjoy the benefits of a lesser-saturated market space unreachable by traditional solar. Third, ASTI has placed a high priority on developing solar technology for the aerospace sector, inclusive of drones, aircraft, and even spacecraft. Solar powered solutions have always been of significant interest to the aerospace industry, and with ASTI’s CIGS technology, the company can out-perform and out-class many of their competitors. For example, the thin and flexible nature of CIGS enables the panels to be directly integrated onto the wings of drones, UAVs, and other aircrafts without causing any extraneous weight or bulk. Not only does this allow for cleaner and renewable energy in these aircraft, but it also eliminates the need for bulky and often power restricted batteries to fuel the unit.

Finally, ASTI aims to capitalize on their extensive list of possible applications by catering to more niche and specialized markets, working closely with individual companies to design a product that best suits their unique needs. Clearly, with ASTI’s modern CIGS technology, there exists significant opportunity in providing solutions to companies and industries that were previously unable to make use of solar power in an amenable fashion; ASTI has taken many of the right measures to set themselves up to capitalize on their strategic initiatives.

A Shift in Focus

While it may be true that ASTI’s share price recently hit a historical low, merely looking at the stock valuation isn’t an objective way of valuing the company as a whole. Additionally, there is a reason that ASTI has been able to remain in business since 2005, while many of their competitors have been forced to declare bankruptcy. As a historical side-note, during the late 2000s, the solar industry began to fall victim to certain difficulties that stifled the growth of the market, leading to a cutthroat competitive landscape that only the well-established and forward-thinking companies could survive. The PV module price per watt, for instance, was at nearly $6/watt throughout the 2000s, and by 2015, this figure had dropped to a minuscule $0.50/watt due to efficiency improvements, as well as energy dumping by predominantly Asian countries. As a result of this sharp and unexpected loss of revenue, companies that did not quickly adapt to the evolving market space saw market share and future potential evaporate.

Many of the companies that went bankrupt during this time made the same fatal mistake: while working with second-generation thin-film solar technology, they chose to keep focusing on large-scale utility and rooftop applications, which forced them to compete in the same market as traditional c-SI solar. Of course, it was impossible for second-generation companies to compete with glass-backed solar technology in this sector, as the older technology could accomplish the same results at a significantly lower cost to buyers. ASTI realized this, however, and in 2012 began shifting their business model to differentiate themselves from the oversaturated utility markets and better highlight the advantages their CIGS technology had over first-generation products. The shift in focus allowed ASTI to separate themselves from the competition and is one of the primary reasons why the company has lived through these industry struggles and sits well-positioned for future success.

Rather than attempting to compete with c-SI solar, ASTI decided to focus on their strengths by targeting specialty, high-value PV applications. The shift is significant because not only are these sectors unreachable by traditional c-SI solar panels, but industries such as military and aerospace are known for having a high barrier to entry, a hurdle in which ASTI has already cleared. Where ASTI may prove their leadership capability is in these unique markets, where the functionality and durability often take priority over the cost of the product, and by operating in a more limited market space, ASTI has a much higher chance of recording substantial sales revenue and build partnership opportunities. And, with second-gen products going for $5-$50/watt, the profits are far more fruitful than the $0.50-$2/watt garnered from traditional applications. To reap potential rewards, ASTI has branched off from commodity-based pricing in favor of a value-based pricing model, effectively shifting the sales model from $X per watt to $Y per unit or solution. Not only does this make pricing clearer for consumers, but it also allows ASTI to work with companies on a case-by-case basis and negotiate pricing.

ASTI Is Charged Up

Having survived through the challenges brought on by a crowded industry, ASTI is ready to begin their climb back into the spotlight and show investors why their current valuation deserves a closer look. Due to dropping below the NASDAQ $1 price requirement, many in the institutional and retail investment space overlook the inherent value in ASTI, ignoring the IP portfolio, the sizable assets, and opportunities that the company is engaging.

First and foremost, the company currently owns a manufacturing facility in Thornton, Colorado that has an estimated worth of over $11 million. Second, the company has put over $300 million into research and development since their establishment in 2005, a testament to their meticulous design process and dedication to their craft. Through this development work, ASTI now has over 40 patents (granted, allowed, and filed) under their belt, all of which relate to their globally-recognized technology and manufacturing processes. This type of IP portfolio is made possible through over a decade of dedicated effort from the team at ASTI, and any emerging company with aspirations to enter the same specialized markets as ASTI would likely face rigorous obstacles and lack both the time and money needed to build a product that could compete.

Not to mention, high-value markets such as military and space travel often come with much longer sales cycles when compared to the more generalized markets, meaning that the majority of contracts would be not only lucrative but exclusive to the company that secured them. Recognizing that value proposition, ASTI has placed their business focus into four strategic verticals, which is expected to pay accretive dividends within the next few years.

First, and not neglecting the obvious, the company plans to enter the consumer portable power market to take advantage of the near $7 billion industry. With high-powered smartphones and other devices often requiring portable batteries to remain charged throughout the day, a growing demand has emerged for portable solar to replace these batteries. And, to support and take advantage of this demand, ASTI has recently partnered with PowerKeep to develop a line of solar panels for the upcoming Energizer® PowerKeep solar products.

Simultaneously, ASTI has secured a partnership with Silent Falcon, an unmanned aerial system manufacturer also headquartered in the US. The flexible and monolithically integrated CIGS in production makes for an easy solution that allows for a notably extended flight time. By combining solar into the wings of Silent Falcon’s airship, 30%-50% more flight time can be added to missions with a minimal impact on the craft’s weight and aerodynamics. The partnership has been successful for the two companies, establishing ASTI’s name as a reliable and competent company within the industry and opening doors to future business ventures.

ASTI also has detailed plans to enter the military sector through various applications of its portable solar technology, inclusive of portable chargers for Android Tactical Assault Kits and other military devices, as well as unattended ground sensors that can increase ISR efficiency while substantially reducing the risks taken on by operators. ASTI participated in the US Special Operations Command (SOCOM) invitation-only Technical Experimentation Event held during the summer of 2017, a prestigious event that gave the company’s solar solutions exposure to military officials.

Finally, ASTI has been selected by the Japan Aerospace Exploration Agency (JAXA) for further evaluation of their superlight CIGS solar cells for deep space missions. The selection is the first ever substantive contract awarded for a high-altitude application, and will undoubtedly jumpstart the company’s foray into space applications should the venture prove successful.

ASTI Is Maturing Quickly

ASTI may indeed be trading at a discounted price, but there are many factors specific to ASTI’s niche focus and market opportunity that can quickly contribute to a far higher valuation than what is currently represented. The value, to those who understand valuation metrics, is easy to recognize. The company has been in business for over a decade and has proven its ability to overcome the struggles of the cutthroat solar industry. Not only that, it is deeply seeded in a specialized sector with high barriers to entry. And, although investors should accept that valuations may not skyrocket overnight, they should also be cognizant of the fact that any newly secured partnerships could prove hugely beneficial to the company’s market cap.

Combining the sum of the parts, ASTI already has the research, product portfolio and IP base in hand, and have carefully set themselves up for a fair chance at becoming the breakout company in their targeted initiatives. All things considered, investors that are willing to have some patience in Ascent Solar may end up finding it very much worth their while.

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. PCG paid CNA Finance $3,500 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Ascent Solar by CNA Finance. All information researched and provided through any article associated with Ascent Solar 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.

Aytu Bioscience Inc AYTU Stock News

Shares of Aytu BioScience are trending higher as the company’s most recent market update highlighting the prescription growth rate for Natesto®, the company’s testosterone replacement therapy product, continues to demonstrate consistent sales momentum and increased market share position.

Natesto® is AYTU’s “Low-T” treatment and stands alone as the only prescription needed topical TRT product on the market that is not required to have an FDA imposed Black Box safety warning affixed to its label. Proving itself safe, effective, and convenient to use, prescribing physicians are increasing their attention to Natesto®, evident by the compounding rate of new prescriptions written during the past nine months, rising in total to their highest level in product history. Factory orders, as well, reached historic highs, as the Natesto® sales force begins to replenish inventory sold by Endo International, sales that were booked before Aytu’s purchase of exclusive U.S. licensing and marketing rights to the product.

Aytu’s Big Push

Investors that are following the AYTU story understand that Natesto® may indeed be a game changer for both AYTU and the testosterone replacement industry. The Natesto® benefit is making itself known, and there is little evidence to refute the data that Natesto® is considered the safest treatment available. Not only is the clinical data compelling, but Natesto® also provides substantial benefit to patients that include ease of use, discreet 2-3 times daily dosing regimen, high barrier to accidental partner transference, and proven effectiveness in providing rapid symptom relief to male patients in need of testosterone replacement therapy. Natesto® is also showing efficacy results that demonstrate its potential to be of superior value in treating common areas of male sexual dysfunction. Key measures of Natesto’s® effectiveness show success in targeting key domains of erectile dysfunction, and importantly does not contribute to changes in LH and FSH hormone levels in users, which is a highly significant product benefit that prevents a series of unintended and potentially severe patient side effects.

Many professionals in the industry acknowledge that the opportunity for Natesto® is substantial. Couple that recognition with the fact that Natesto® prescription rates are continuing to post record volumes, then it becomes easy to understand why institutional investors, who just invested over $11.8 million into AYTU, believe that Natesto® can indeed become a best-in-class product and holds promise to penetrate the multi-billion dollar market. But, it’s not only the team at AYTU that believes in specific routes to success. Shrewd investors understand that the more disruptive Natesto® is to the TRT market, the more likely it may become that large pharmaceutical companies will recognize the value in their newest emerging competitor, and formulate strategic decisions as to whether or not Natesto® should remain as a competitor or become an in-house ally to protect market share.

From a market perspective, for those that acknowledge the limitations of most marketed TRT products and then compare them to the benefits of Natesto®, the apparent Natesto® advantages present potential partnership, licensing, or strategic collaborations that may provide a lucrative opportunity for AYTU. And, that’s why Natesto’s® disruptive nature may prove to be extremely valuable to others that have invested hundreds of millions of dollars in creating a drug that is inferior to Natesto®. Because, if they can’t beat Natesto®, they better try to join them. And, while investors should never purchase stocks based on takeover or licensing rumor, the value added from MiOXSYS®, Fiera®, and ProstaScint®, Aytu’s other approved for market products, indeed embellish the AYTU proposition.

Natesto® Prescriptions Did What?

Taking a page from Aytu’s most recent market report, Natesto® prescription rates again spiked during August, this time pushing a 25% increase over July totals. Year over year new orders, which is a broader indicator of the longer-term trend, posted substantial growth in new prescription volume by increasing roughly 178% since March of 2017. An impressive and necessary component of that growth gets strengthened by the number of new prescribers that are offering Natesto® to their patients, which grew by 18% over July and posted a 78% increase over March of 2017. Currently, the number of Natesto® prescribers stands at 351 and has recorded sequential monthly growth since March of 2017.

The Factory Is Buzzing

On the production side, factory sales orders for August were $518,000, corresponding to a sales growth rate of approximately 25% over July. Based on the established trend, AYTU management believes that the company may be positioned to reach cash-flow break-even status in the next twelve to fifteen months.

Not only should investors be encouraged by the Natesto® growth trend and sales visibility, but AYTU management, as well, is also pleased by the data. From its market report, management highlighted the strength in August sales and believed that the message gained from the highest single month factory sales revenue serves to reinforce the pattern established during the previous nine months. Not only does the prescription volume surpass historical levels, but the sales visibility that is now in place for Natesto® may also provide a reliable forecast for future sales and market growth.

What It Means For Investors

For AYTU investors, the progress made on several corporate fronts are lining up to provide a promising year. Accounting for product and corporate developments, the reality is that AYTU may be the only provider positioned to meaningfully alter the course of industry sales, by offering the safest and most effective combination of TRT solutions. Being the only nasally-administered TRT product available on the market provides its own set of benefits. But, beyond being easily administered, Natesto® delivers convenient 2-3 times daily dosing and remains as the ONLY topical testosterone replacement product that the FDA deems safe enough not to have the most severe of safety labels prominently exposed on its label.

For both current and new users, Natesto® may offer the best treatment option on the market. It’s safe, it’s effective, and we expect that the product will continue to secure an increasing level of reimbursement coverage from major insurance carriers across the country. Also, AYTU offers its prescription aid plan that allows patients to purchase the product for as low as $25.00 per month, and in a worst case will not cost a user more than $150 for a prescription. The product price compares extremely favorably to competing products, which can cost upwards of $500 per month and at the same may induce severe side effects and produce less therapeutic benefit.

Successful investors need to dig deep to find good opportunities. In that respect, investors that are considering an investment into AYTU may be well advised to take advantage of a future that is already beginning to reveal itself. Natesto® is FDA approved for marketing in the United States, eliminating a substantial portion of regulatory oversight and has cleared the significant barrier to entry challenges associated with newly developed products.

Investors should also take near-term financial worries off their minds, based on AYTU’s recent capital share restructure and it’s $11.8 million private placement. Moving forward into the fourth quarter, AYTU is in its best financial position in its company history and has in place a cash runway to bring the company toward expected breakeven and potential EPS territory within the next fifteen months. Although growth pains and pas hurdles slowed AYTU at times, the company is now well situated to quickly target and develop the potential of Natesto®, committing a strong sales force to drive new prescription rates higher throughout the United States.

While it may seem unfathomable, the FDA has allowed a multi-billion dollar, high demand TRT market to get filled with less safe TRT options, with several approved products purported to have significant potentially life-threatening side effects. That is NOT the case for Natesto® and is one of the primary reasons that many investors and practitioners believe that the product is destined to find its place and earn a substantial piece of the current $2 billion market.

Undivided Interest For Aytu’s Natesto®?

All told, for investors interested in the TRT space, perhaps the safest place to be is alongside AYTU and Natesto®. For one thing, unlike its competitors, Natesto® is relatively immune from regulatory pressure and potential consuming legal exposure, an enviable position to be in that may stoke the comparative benefits and lead physicians to prescribe Natesto® which has minimal health risks. And second, when doctors eventually conclude that the benefits of Natesto® far outweigh their resistance to change, they may finally acquiesce to prescribing a product that is not only proven safe but is shown to provide the same, or better, therapeutic value to patients. Beyond those benefits, Natesto® is up to 300% less expensive, per month, in some cases.

No matter how much information gets presented to an investor, the ultimate and most pervasive question is – At current share price levels, is AYTU a gift?

While the fortune cookie logic of investing is still working its way toward the mainstream, investors do have the opportunity to look at past, present, and near-term data that provides a rationale for making an informed investment decision. In taking the sum of the parts for Aytu BioScience, several compelling points of interest lead toward an opinion that investing at these levels may be a wise idea. Not only does AYTU have an active and developing pipeline of already approved products, but when peer market caps get used as a comparison, then AYTU appears to be significantly undervalued. Although AYTU is playing in a field with significant power players and institutional bias, smart investors understand that AYTU does not necessarily need to compete straight up in the TRT market to achieve enormous success. In fact, if AYTU is successful in earning just 5% of the current $2 billion opportunities, the rewards can be substantial and increase shareholder value well beyond even the most optimistic of market cap prognosticators.

To simplify the valuation analysis, if Aytu BioScience simply keeps its head low and focuses on grabbing 5% of the market, or roughly $100 million, AYTU may prove to be a gift at these price levels. But, beyond the potential value appreciation, taking advantage of the emerging growth curve at AYTU may also allow for bragging rights for finding an undervalued opportunity that actually delivered upon its enormous potential.

Vitality BioPharma VBIO Stock News

Vitality Biopharma is still one of the top three companies in the cannabis sector positioned to benefit tremendously from the continued passage of legislation legalizing marijuana-based compounds for medical use. Despite a share price that is showing a clear disconnect from competitors like GW Pharma (GWPH) and Arena Pharmaceuticals (ARNA), Vitality Biopharma (VBIO) continues to position itself for substantial growth opportunity in the next several quarters. As VBIO’s studies continue, the company is encouraged by both pre-clinical and case study data which suggest that Vitality Biopharma is well on track to create meaningful THC prodrug treatments for Inflammatory Bowel Disease (IBD) and Narcotic Bowel Syndrome (NBS).

Since 2014, retail investors continue to concentrate on stocks within the cannabis sector that are hoping to create shareholder value through the cultivation and sale of marijuana-based products. However, smart investors stay focused on more realistic value creation opportunities by focusing attention on stocks that are building an impressive intellectual property (IP) portfolio that will serve to protect their market position for the next two decades. Not only is VBIO creating value through the patent approval process, but they are also securing a dominant treatment position in treating severe inflammatory diseases that plague both pediatric and adult patients.

While two other companies, GW Pharma and Arena Pharmaceuticals are also well entrenched into delivering their unique cannabinoid compounds to treat various medical conditions, VBIO’s concentration is more tightly focused on bringing to market specialized cannabinoid products that target inflammatory diseases. Specifically, VBIO’s attention gets centered on treatments that demonstrate tangible and remission inducing responses in a market that is in need of curative treatment, instead of a symptom-only therapeutic drug. Thus, in addressing IBD and NBS specifically, VBIO will benefit not only from the significant barriers to entry for new competitors but will further enjoy product and market exclusivity in treating these diseases for the foreseeable future.

The IBD And NBS Market Is Complicated

To date, current front-line therapies of both IBD and NBS often fail to produce a meaningful or sustained effect for patients. Most treatments are only addressing symptoms, which often include excruciating abdominal pain, infection, bloody diarrhea, and joint pain. Patients with these ailments often receive opiate and steroid treatments, which are ineffective for many, cause severe long-term side effects, and in the case of NBS, actually represent the root cause of the disease, where opioid treatment causes excruciating and persistent abdominal pain

To address these treatment deficiencies, VBIO is developing THC based prodrug treatments to combat both IBD and NBS effectively, targeting the estimated 81% of opiate users with functional bowel disorders, and the over 58% of patients who report chronic abdominal pain. Thus, while the patient population remains starved for a treatment that can induce disease remission, the current standard of care is simply failing for many people with either illness. But, don’t expect big pharma to relinquish its stronghold on treating just the symptoms. The real pressure to create change must come from the patient population, sector advocates, and from companies like VBIO that are demonstrating the value in alternative cannabinoid treatment to curb both symptoms and disease progression.

A strong example of what VBIO may be able to offer patients may get exemplified through clinical study. Vitality Biopharma’s VITA-100 and VITA-210 trials, expected to initiate in 2017, are targeting treatment applications for both IBD and NBS in its separate Phase 1a/1b trials. This first-in-man clinical study of proprietary cannabinoid glycosides (cannabosides) is intended to measure and evaluate the pharmacokinetics and tolerability of cannabosides, and to provide preliminary efficacy data in treating abdominal pain, cramping, and other symptoms associated with each condition. In addition to targeting IBD and NBS, the company’s gut-targeted cannabinoids will also be investigated for the treatment of neuropathic pain, opiate-induced bowel dysfunction, colorectal cancer, and C. difficile indications.

Potential benefits of these low-cost and relatively quick clinical studies, which historically cost less than $2 million and take less than six months to complete, will likely serve as a means to generate both safety data and also proof-of-concept data relevant to several large market gastrointestinal disease indications. Not only is VBIO positioned to advance these trials quickly and cost-effectively, but the internally produced proprietary molecules and use of enzyme biosynthesis processes to create cannabinoid treatments also allow VBIO development independence and the ability to control the pace and conduct of the trial.

Case Study Benefits Pediatric Crohn’s Disease Patient

Being self-sufficient from pre-clinical study to manufacturing processes, VBIO is well positioned to take quick advantage of research results and apply them toward additional medical applications. Within the subset of current IBD and NBS patients, for instance, VBIO published a case study for a pediatric Crohn’s disease patient that produced encouraging results. Data from the study demonstrated success with cannabinoids when all front-line treatments were ineffective. Although preliminary results are promising, VBIO does suggest that additional studies will be required to substantiate its proof-of-concept and therapeutic value in using cannabinoid compounds to treat the disease. But, keeping in mind that additive studies are both quick and inexpensive compared to the alternative drug approval process, the additional studies do not pose a serious drag on potential cannabinoid and THC modeled prodrug approvals.

The recent case study published by VBIO describes a 13-year-old boy with Crohn’s Disease who achieved clinical and biochemical remission after oral administration of cannabinoids. Elements of the case study showed that after years of disease, the patient suffered from a poor appetite, consistent weight loss, incurred stunted growth, and most important from a treatment perspective, failed to achieve remission with conventional therapies, including the markets most promising TNF-alpha inhibitor infliximab.

According to VBIO’s case study presentation, the 13-year-old patient received a formal diagnosis as having Crohn’s disease at the age of 9, whereby mild-to-moderate distal colitis and aphthous ileal ulcerations were acknowledged. During the next four years, the patient was hospitalized on numerous occasions and placed on a treatment that included the use of alpha inhibitors and a morphine drip. After being treated for roughly five years (in five-week intervals) with the most advanced conventional therapies, the patient failed to enter any state of disease remission. Even after introducing additional medicines, including sulfasalazine, Lialda, CANASA, and azathioprine, the patient showed no significant response to treatment. The most aggressive attempt to control the patient’s disease included the introduction of Methotrexate, but caused severe side effects that forced the treating physician to stop the treatment. The only shown benefit the patient experienced was for a brief period when infliximab was the predominant treating compound. However, that result quickly dissipated, and the calproctectin levels in the patient increased to more than 2000 μg/g during the next four months of treatment.

During the four years of disease progression, the patient was unresponsive to conventional therapies, and symptoms continued to worsen causing poor appetite, weight loss, anemia, and continued stunted growth. Additionally, the patient missed 25 days of school per year on average and was hospitalized on a regular basis for Crohn’s symptoms that included intense stomach cramps, anemia, and bloody diarrhea frequency between 10-20 times per day. Inclusive to those debilitating effects, the boy also suffered from five consecutive infections with C. difficile which required hospitalization. Unfortunately, even the most prominent antibacterial medications, including vancomycin were ineffective, leading to the need for treatment with fecal transplants, which ultimately resolved the infection and achieved temporary remission of his IBD. But, the road to a short-lived reprieve was intense and not without extreme cost and patient discomfort. Watching the deterioration and treatment setbacks, his parents decided to seek alternative treatment after learning of the success of Coltyn Turner, a pioneering cannabinoid patient who reported complete clinical remission of similar drug-resistant Crohn’s Disease after using cannabis-based compounds. The results, produced by treatment after all conventional therapies were tried and failed at the Mayo Clinic, demonstrated the value in cannabinoid treatment of the disease for a drug-resistant pediatric patient.

Following the lead from these encouraging results, the VBIO case-study patient received approval for treatment with cannabis under the California Compassionate Use Act, and in mid-February 2016, began cannabinoid therapy with three daily doses of chocolate bar edibles that were each infused with 3mg of THC and 3mg of cannabinoid. Within thirty days, the patient, who had never responded to conventional treatment, had achieved disease remission, and both his calproctectin scores and calproctectin serum levels decreased significantly. After sixty days of cannabinoid therapy, the calproctectin levels decreased to 0mg/L. Of additional significance, the associated serum erythrocyte sedimentation rate declined by 88%, from 25 mm/hr to 3 mm/hr.

Eliminating Infliximab Infusions

The case study also produced additional benefits, including the reduction of infliximab infusions from every five weeks to nine weeks. Despite the objections made by the patient’s attending gastroenterologist, the patient stopped all infliximab treatments during January of 2017, whereby the patient was diagnosed to be in complete remission, with no Crohn’s disease symptoms.Fast forward to the date of publication, and the patient remained in disease remission for more than one-year since starting cannabinoid therapy, gained height and weight, had a healthy appetite, and had not missed a single day of school. Importantly, from a regulatory perspective, the cannabinoid treatment created no adverse reactions or side effects.

Particular to the case study, the results of the cannabinoid therapy prove to be of substantial importance to an illness that avails itself to mostly ineffective treatment options that also fail to deliver measurable long-term results. The study findings are significant to VBIO, whose THC prodrug is specifically aiming to address the symptoms as well as the inflammatory aspects of the disease. Although this is the first documented report of cannabinoid therapy inducing clinical remission in a pediatric IBD patient, the results and outcome presented used objective measures of disease activity and scale rating. Certainly, patient response is more reflective of actual disease progression and symptom relief, but both retrospective and prospective studies of the analysis demonstrate that the use of cannabinoid provided a significant improvement in the quality of life for the patient. No doubt, the results produced serve to reinforce the promise of cannabinoid therapy to provide far more than symptomatic relief.

Vitality Biopharma’s Unique Applications

VBIO’s prodrug technology may alter the landscape of how both IBD and NBS gets treated and is building a platform based off of reliable data that is showing the benefit of cannabinoid treatment. Vitality’s use of glycoside prodrugs, for instance, can selectively target different tissues, including the gut through oral delivery and the brain through intravenous administration. Utilization of the glycoside prodrugs with cannabinoid compounds has already demonstrated reliable targeting to the colon, and data indicates glycoside technology can also enable higher permeation of brain tissue upon intravenous delivery.

Specifically relevant to VBIO’s cannabinoid platform, the glycosylation technology has reliably led to improvements in drug solubility and stability and has set the stage for a novel set of cannaboside compounds. For investors looking for comparison potential, GW Pharma’s more than $2.75 billion market cap lay mostly in its IP portfolio, and the expectations from its IND and NDA drug applications. It’s easy to point out, after all, that with only $3.1 million in most recent quarterly revenues, and a cash burn of almost $34 million, much of GWPH’s market cap is built on the belief that investors have in the blue sky potential of the cannabinoid industry.

VBIO is setting itself up for similar appreciation. The trials that are scheduled to start later this year, coupled with the growing IP portfolio and over 20 submitted patent applications, likely positions the company for an uptick in shareholder value. Similar to GWPH, Vitality Biopharma may quickly take advantage of its clinical data to expedite its therapies and seek FDA approvals through IND, NDA and accelerated approval pathways through 505(b)1 and 505(b)2 filings.

The ultimate promise for VBIO lay in the fact that the company has indeed developed a novel class of cannabinoid compounds that, when used in prodrug form, may lead to potentially revolutionary developments in how inflammatory diseases get treated. By providing a site-specific method of delivery, the VBIO prodrugs can effectually offer local therapeutic benefit, and at the same time eliminate systematic delivery of cannabinoid and THC based drugs into the bloodstream and brain, removing the psychoactive response in users. And, don’t underestimate the value VBIO’s method of delivery, because while competitors may eventually progress toward both pre-clinical and clinical trials, they will be limited to the amount of cannabinoid and THC used due to the psychoactive effects of not using the prodrug technology. That limitation alone establishes significant disadvantages to any potential competitor and fortifies the market leading position that VBIO may enjoy in the IBD and NBS markets.

The Promise For VBIO

From a market perspective, investors should embrace the substantial revenue opportunity at hand, with a current IBD treatment market alone expected to generate more than $9.6 billion in 2017. And, while this aggregate number represents a total treatment market that includes anti-inflammatories, immune-suppressants, and antibiotics, none of the current treatments have demonstrated the ability to cure the disease. VBIO, however, is banking on the compounding data that its treatments will indeed cause substantial and improved patient benefit. Thus, while large pharma and potential competitors may look to control and manage symptoms, VBIO is engaged to in methods intended to place the disease into a long-term state of remission.

For investors, the VBIO prodrug technology offers dual benefit. First, it may provide almost immediate systematic relief in patient symptoms. Second, it may allow for patients to eliminate the need for opioid-based drugs that often lead to misdiagnosis, drug addiction, and additional complications that contribute to the progression of disease symptoms. Now that two key trials are set to begin, VBIO investors are sitting on at least two potential catalyst events for the remainder of the year. Not only are those trials expected to commence soon, but VBIO may also leverage the recent Crohn’s disease case study results to maximize FDA attention to offer expedited pathways for treatment approval. Although VBIO may sometimes get lumped into the micro-cap world of marijuana stocks, the reality exists that VBIO is far from the typical cannabis stock, and is rightfully deserving of a higher market cap than is presently provided. Even with a cursory comparison between GWPH and VBIO, investors can see stark similarities, making the difference in market cap valuation confusing.

In some respects, VBIO’s position in getting treatments to market is similar to GWPH, but at the same time, VBIO will not burn more than $120 million per year to advance its pipeline. What GWPH serves to show investors is that while the big money brokerage houses may make investment bubbles for companies that are yet to prove themselves worthy of multi-billion dollar market caps, they continually ignore investment opportunities that have not relied on their investment roadshows or equity interest to drive exposure. With VBIO trading at less than $2 per share, and with trials set to begin that may elicit expedited FDA review, the better investment opportunity in the small set of cannabinoid developers may lean toward VBIO’s favor, making the stock a worthy consideration for investors.

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. Worldwide Holdings paid CNA Finance $3,000 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Vitality BioPharma by CNA Finance. All information researched and provided through any article associated with Vitality BioPharma 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.

Although some retail investors are feeling the burn from a tumultuous year in Ascent Solar stock, others believe that a buying opportunity is clearly at hand. Despite a history of convertible debenture financing and a sometimes fickle solar market, ASTI investors may finally be positioned to emerge as both near and long-term winners, with ASTI intent to capitalize on its ambitious and strategic plan to create shareholder value in a market that is in need of the company’s technologically advanced solar products.

In the interview below, ASTI management told CNA Finance exactly how it’s company lost market cap value, and what it plans to do to recapture it’s solar glory, laying out a strategic vision and path toward what ASTI management believes will lead to substantial, near-term opportunities for the company.

CNA Finance: Ascent Solar is a prime example where investors can get fooled into thinking that a company’s share price is an accurate measure of a company’s inherent value. However, while that may not be the case from an objective valuation measure, the share price is indeed a factor that investors rely on to represent perceived fair value. Before we get into the massive transformation that is taking place at Ascent Solar, briefly discuss what exactly happened to cause the share price to reach these historically low levels?

Ascent Solar(ASTI):: Just like any commodity and/or foreign currency, a stock price is simply a function of the law of demand and supply, which is a complex function of multiple factors that include both fundamental valuation and non-fundamental reasons. These non-fundamental factors broadly include public news or rumors, investors’ expectation (driven by greed or fear), and momentum driven by short-term traders, just to name a few.

From a fundamental perspective, Ascent’s stock price has been severely affected by the challenges faced by the industry which witnessed a sharp decline in the average selling price of the incumbent crystalline silicon-based (c-Si) solar cell, from as high as $6/W a decade ago to less than $0.50/W today, resulting from technological and efficiency improvements as well as a huge influx of dumping, predominantly by Asian countries. These factors have forced many of the so-called “2nd generation thin-film solar technology” startup companies, established in the last decade, to go bankrupt, stop operations, or be acquired at a tiny fraction of the sunk-in capital. The most notable being: the high-profile 2011 bankruptcy filed by privately held Solyndra, LLC., who received $535 million in federal loan guarantees; the bankruptcy of publicly traded Energy Conversion Devices (ENER), also known as Uni-Solar in February 2012; and SoloPower Systems, who have repeatedly defaulted on the DOE guaranteed loan from the State of Oregon.

While it is a reality that Ascent’s stock price has hit a historical low, we hope that current and potential shareholders recognize and appreciate that Ascent Solar has and can survive the “perfect storm.” Our unique proprietary technology and manufacturing process allowed Ascent to pivot our strategy and business model to focus on the high-value specialty PV markets not attainable by the rigid and fragile c-Si PV panels. Our undisputed leadership in the lightweight and flexible PV world is underscored by the numerous awards given by world-renowned institutions, such as: The 100 Most Innovative Technologies by R&D 100 Magazine in 2010: The 50 Best Inventions in the World by Time Magazine in 2011: and again, The 100 Most Innovative Products in the IT/Electronics Categories by R&D 100 Magazine in 2015. That no other solar cell manufacturers have won any award like these, let alone three, speaks to the state-of-the-art technology & products we have developed.

On the other hand, the delisting from NASDAQ (due to not maintaining the strict minimum $1 bid-price requirement) has excluded many interested and would be institutional investors who must work within certain investment framework/criteria, as well as other would-be investors that were rejected by many security firms because they would not accept buy orders for OTC stocks. This has directly cut off a huge portion of the demand side of the equation!

CNA: Okay, that’s a fair response, and most informed investors understand that emerging companies are almost always at the mercy of what some may call “aggressive financiers.” There is little argument that the benefit of being a publicly traded company and having the ability to tap the equity markets for financing ultimately pays its dividends. With that said, Ascent Solar appears positioned to capitalize on a business strategy intended to maximize asset and shareholder value. For investors considering taking a stock position today, what can they expect ASTI will do to drive shareholder value and to advance the company’s commercialization strategy?

ASTI: I trust that investors have taken notice of the many positive developments Ascent has announced, such as: being selected by the Japan Aerospace Exploration Agency (JAXA) for further evaluation of our superlight CIGS solar cell for deep space mission, the first ever large contract awarded (and partially shipped) for high-altitude application; participation in the US Special Operations Command (SOCOM) exclusive invitation-only Technical Experimentation (TE- 17-3) Event held on July 17-19, 2017; and most recently the selection by PowerKeep to develop and supply solar panels for the Energizer® PowerKeep Line of solar products. All these achievements are by no means a fluke, given the credentials of the parties with whom we are working. In addition, we achieved ISO 9001:2015 certification earlier this year, which is a pre-requisite in many of the high-value PV markets that we are pursuing. These are the markets with extremely high entry barriers and with primary purchasing considerations driven more by the reliability, durability, and practical functionality of the product, as opposed to a pure cost factor in the traditional PV market, which caters to utility projects or rooftop applications.

I firmly believe that Ascent Solar, after years of R&D and development effort in these highly specialized, but lucrative markets, is well positioned to be a dominant player, and create shareholder value, as these markets begin to grow exponentially.

CNA: Many investors may not even realize that Ascent Solar is a pioneer in the solar industry, commercializing solar technology that has been researched and developed during the past two decades. We will get more in-depth in a moment, but can you describe in simplest terms the competitive edge that Ascent Solar enjoys particular to CIGS flexible technology?

ASTI: Copper indium gallium (di)selenide, otherwise known as CIGS, is a thin film technology that holds several advantages over standard monocrystalline solar cells. While monocrystalline technology can be thick, heavy, rigid, and fragile, our CIGS solar technology is thin, flexible, lightweight, and most importantly, shatterproof. Ascent Solar holds several key patents that allow our CIGS technology to be produced on a polyimide (plastic) backing. This polyimide backing allows us to monolithically integrate our solar cells, through a laser pattering process, to each adjacent cell surrounding it, allowing electrical current to flow around any unexpected damage to the panel. As an example, if one of our solar panels were punctured or cut, the electrical current would flow around the damaged area and to the terminal location. Most other thin-film and monocrystalline panels are not monolithically integrated, meaning that if one cell of the panel is damaged, the whole device can be rendered useless. This revolutionary technology allows us to take our solar to more remote locations and extreme environments.

CNA: So, for investors to get a grasp of exactly how important and revolutionary this CIGS product may become to multiple industries, can you speak to the potential market applications to various sectors. Also, from a commercialization perspective, are there specific markets that ASTI expects will become hundred billion dollars, or higher, market opportunities?

ASTI: Yes, I’m glad you brought that up. While many solar companies continue to focus on utilities, building applied PV (BAPV), and rooftop applications, we understand that market is becoming highly saturated, driving down the price of solar. We fully appreciate there are specific markets that will pay a higher $/watt for this innovative technology since our solar can operate in the most extreme environments. The military, government, public sector, and disaster relief markets have been a large focus for ASTI based on the fact that these markets look for dependable solar that withstands wear and tear over extended periods of time. Batteries and other forms of power are the 3rd heaviest item a soldier will carry on their pack in deployed scenarios, just behind water and oil. The government and military are looking for lightweight and rugged solutions to recharge equipment on the go. This is where we come in; we can provide some of the lightest and most flexible solar for man-portable scenarios, that can withstand the rugged usage that most soldiers will put their equipment through. In addition, we have identified disaster relief as a tremendous opportunity for our solar technology. With the disasters that have hit our shores in the past month, being able to bring portable power to the end user is critical. Whether it is working with non-government organizations, the private sector, or the end consumer, we know that our products in the hands of these disaster victims can be life-saving.

Another market that is a high priority for the company is the aerospace sector which includes drones, high-altitude aircraft, and spacecraft. Not only is this a high-revenue market, but our solar technology makes us a perfect fit for these opportunities. Concerning our technology, CIGS has higher performance in low-light conditions than other solar technologies. This essentially means that our solar will have elevated levels of output even when further away from the sun. We have already partnered with organizations like JAXA to provide solar for their deep space missions and have become a prime candidate for several other opportunities in the space sector.

In addition to spacecraft, our thin-film CIGS gives us the ability to integrate our solar directly into the wings of drones, UAV’s and aircraft without adding bulk to the vehicle. This offers an attractive trade-off over additional batteries built into the aircraft, which can add significant weight to the unit. Finally, we can provide engineering services and assistance for electrical interface systems and custom PV integration, so if you have a custom product you need a solution for, we will work with you all the way from conceptualization to finished product.

The final market we’ve placed a large focus on is the Consumer/OEM space, where there is large revenue potential for co-branding power solutions for the consumer electronics space. But we’ll cover that in a later question.

CNA: You mentioned the military applications a moment ago. Actually, in 2015, R&D Magazine selected Ascent Solar’s innovative Military Graded foldable PV Blanket as a Top 100 Technology in the IT/Electronics Category. What applications did that publication find most appealing to warrant the recognition?

ASTI: Our MilPak™ 60E was the first demonstration of a fully self-contained portable PV power system. The unit consists of a 60W folding PV blanket for power generation, a junction box that contains a dynamic maximum peak power tracking circuitry (MPPT), a charge controller for the lithium battery system, a lithium battery (84 Whr) with battery management system, a high-power (55W) power regulation circuit for selected 19V to 28V DC voltage, and two USB charging circuits. So essentially you could deploy the MilPak, charge it from the sun, and use the built-in battery to charge a wide variety of devices wherever your mission took you. Furthermore, the connectors and ports were designed to be with an IP-67 rating, or better, for moisture and dust ingress. This product was a prime example of our design capabilities, which was further demonstrated by our ability to pass testing under the MIL STD 810G guidelines, and thus became a product that helped open doors for several contacts in the military and government space.

CNA: Also, it’s important to point out that most publicly traded stocks, at any price level, do not get recognition from Time Magazine, which ASTI received in 2011. Time Magazine recognized your company as a Top 50 Best Invention for that year. Apparently, industry experts are impressed by what your business is doing. Fast forward six years later, is 2017-2018 potentially the break-out year for ASTI?

ASTI: We firmly believe that we’re setting ourselves up for long-term success. Are we confident about our ongoing partnerships and contracts and partnerships that we are negotiating? Yes, very much so. We’re very excited about 2017-2018, where we will continue to share more exciting news that has been in the works. But to your question, yes, we are building a strong foundation and are hopeful that 2018 will be a promising year for Ascent Solar to take off.

CNA: Again, investors may look at the current share price and not even consider the fact that ASTI has invested over $300 million in R&D, engineering, and manufacturing equipment. That amount of R&D is significant. What can the company show investors as proof that their investment patience will be worth the wait, and even more important that the current share price fails to recognize particular asset components of ASTI?

ASTI: First of all, we own a manufacturing facility in Thornton, Colorado that is worth about $11 million, if not more, based on comparative market indications. This is carried on our balance sheet at net book value of about $4 million. Secondly, Ascent Solar maintains an IP portfolio of over 40 patents (granted, allowed, and filed) relating to our world award-winning technology and unique manufacturing process. This IP portfolio is a direct result of several hundred million dollars of R&D and engineering work, which were not able to be capitalized and, therefore, are not reflected on our balance sheet. Put simply, with due respect to any ambitious corporation, they would have to invest the same amount of money, if not more, and probably a decade of development work to get to where we are today; let alone having to avoid infringing on our IP. The specialty markets that we are focusing on have extremely long sales cycles that I hope investors can understand and, most importantly, appreciate the fact that a breakthrough would bring about potentially huge and lucrative contracts that would not be easily unseeded by competitors.

CNA: So, you mentioned patents, which serve to fortify and protect market advantages. What are some of the essential patents that may help to keep competitors at bay? And, since many competitors are precluded from using your innovative product designs and features, is ASTI willing to enter into strategic partnerships or licensing deals to monetize certain assets?

ASTI: Several of our unique patents are on the ability to produce our CIGS on a polyimide (plastic) backing. This leaves every other CIGS manufacturer to build their solar on a glass or metal support, both which have their disadvantages. Glass construction can be rigid, more fragile, and far heavier than our product. Products using a metal backing may be lighter and more flexible than glass, but they do not allow for monolithic integration; the process that allows our panels to be some of the most durable solar panels on the market.

Several of our other patent filings involve other key aspects of the manufacturing process, which must remain confidential. However, I can assure you we are not worried about those methods or processes being imitated or copied.

With this proprietary technology, it allows a tremendous opportunity for unique partnerships with companies that value our niche technology. As mentioned earlier, we just entered into a partnership with PowerKeep to develop and supply solar panels for the Energizer® PowerKeep line of solar products. We hope this partnership not only brings us financial success but also opens the door for future licensing and OEM opportunities.

CNA: I read that ASTI is recognized as the “one and only” solar manufacturer in the world that is commercially producing monolithically integrated, flexible, CIGS products on a plastic substrate, which can offer significant and global opportunity. How do you envision capitalizing upon this unique leadership position?

ASTI: It’s always been a high priority to get solar in the hands of the right end-users. As mentioned in a previous question, we are targeting a particular group of markets that will value our highly-innovative solar technology. These large revenue markets, unfortunately, carry longer sales cycles. We have been working diligently with several partners and customers to bring these concepts to fruition. Once these projects begin to be completed, we will start to see a “snowball effect” of orders where we can point to several examples of success in each market, which will, in turn, build trust and bring in more opportunities.

CNA: Most investors and consumers still have a misconception about how solar panels work. ASTI is revolutionizing the market in significant ways. Can you tell investors what sets Ascent Solar apart from others in the industry?

We are the only company that can produce thin-film solar, on a plastic backing, with monolithic integration. The rigid panels you might see on a rooftop can be heavy, rigid, and fragile, and if damaged, will cease to operate. Our thin-film CIGS carry significant weight savings and are more flexible than standard solar technology. This allows us to apply our solar to places where another solar can’t go, such as curved surfaces, locations with low-light performance, and areas with extreme temperature fluctuation. Finally, the ability to build our solar on a polyimide backing allows us to monolithically integrate our solar cells, making it some of the most durable solar on the planet.

CNA: So, taking advantage of these exclusive benefits, commercialization opportunities may be substantial in the aerospace, outer-space, military defense and, even the drone industries. Is ASTI prepared to target those markets?

ASTI: Definitely, our unique technology makes us the perfect fit for markets that place a high emphasis on weight and durability. As discussed earlier, all of these markets are willing to pay a premium for, frankly, a better engineered solar cell than most others on the market. Success in these markets will help open the door for future opportunities.

CNA: Two emerging sectors that many investors have still not embraced in investment terms are the drone and solar transportation markets. Both of these markets will develop into significant multi-billion dollar opportunities. Are there specific areas that ASTI can immediately target to maximize its competitive footprint, and at the same time solidify long-term relationships with major manufacturers in those sectors?

ASTI: Yes, we already have a partnership with Silent Falcon, an unmanned aerial system (UAS) manufacturer here in the US. The ability for us to seamlessly integrate solar into the wing of their airship added minimal impact upon weight and aerodynamics and added 30-50% more flight time to their missions without additional batteries. The Silent Falcon partnership has already opened many other doors for business in the drone and transportation space, as we have shown to be a competent and reliable partner for creating innovative solutions to several industries’ power needs.

CNA: Insightful investors understand that solar related opportunities in the military, drone, and transportation industries are enormous. However, the consumer products market is also in its infancy. How well is ASTI positioned to take advantage of that multi-billion dollar market and what type of solar products will you target to consumers?

ASTI: Ascent Solar is very familiar with the user space, as evidenced by our previous brand, EnerPlex. The fact of the matter is that the demand for news, imagery, video, social media and more at our fingertips far outweighs what most portable electronics can provide regarding battery capacity. Simply put, our batteries on our smartphones, tablets, action cameras, and drones, for the most part, cannot last through a full day without being recharged. With this need for power, the portable battery market has exploded; however, we still believe there is a high demand for portable solar in this space. Unlike portable batteries, solar provides you an infinite supply of power without sacrificing weight or size. Our recent partnership with PowerKeep, to develop and provide solar panels for the Energizer® PowerKeep Line of solar products, is evidence that others feel the same way. It’s our goal to find a wide variety of partners that want to integrate our solar into their consumer devices. These could be backpacks, portable solar chargers, or whatever else our future partners want to collaborate on and create with us. The consumer electronics market is valued at almost $7 billion, so there is a high emphasis for us to be a part of this space.

CNA: Finally, assuming that ASTI’s strategic initiatives gain the market traction that you expect, where can you envision ASTI to be positioned in the next five years?

ASTI: While concentrating on our desired specialty markets, we continue to place a strong focus on our R&D process and manufacturing plant. It is a continual goal to increase our solar efficiency, lower our build costs, and increase yield and volume. As we take stronger holds in our previously described markets, we will continue to branch out into other high-revenue markets where clean and portable power is desired. So in 5 years’ time, I hope we can fulfill our Corporate Vision Statement. To deliver clean and innovative power solutions for everyone everywhere.

Closing Thoughts:

Although ASTI is trading at incredibly low levels, an opportunity for near-term value appreciation is substantial. Keeping in mind the current level of outstanding shares at ASTI, investors should remain realistic about near-term price levels, but at the same recognizing that increases of significant percentages may be in order. With ASTI management laying out a plan and addressing investor concerns, shareholders interested in the stock have a palate of data to appreciate. Although no investment comes without risk, the current price level and market position at ASTI leads many investors to believe that the worst of days are now well behind the company. Perhaps it is time for investors to pay attention to what ASTI has to say and to take advantage of an apparent investment opportunity.

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. PCG paid CNA Finance $3,500 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Ascent Solar by CNA Finance. All information researched and provided through any article associated with Ascent Solar 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.

Oncosec Medical Inc. ONCS Stock News

The fight against cancer has always been at the forefront of the biotech industry. As the methods of attacking and healing cancer can vary greatly between different companies, researchers are always searching for newer and more effective ways to combat the disease. Likewise, experienced biotech investors are always on the lookout for emerging opportunities that show promise in bringing a new treatment to the table. OncoSec Medical Incorporated (ONCS) is maturing as one of those niche companies that has earned significant interest from investors and sector partners alike, thanks to its robust and differentiated approach to cancer treatment.

ONCS Advances With Novel Platform

OncoSec, a San Diego based biotechnology company, is combining over two decades of research and development processes that may very well define a new chapter in how disease gets treated. The company’s mission is laser focused on developing new and effective ways of treating various types of cancer, specifically through their innovative and proprietary immunotherapy treatments. OncoSec’s focus is intent on developing immunotherapy benefits designed to address an unmet medical need in the market by providing a proven safe and clinically effective treatment for anti-PD-1 relapse/refractory patients, alongside other cancer indications.

Immunotherapy, as biotech investors know, has become an industry buzz-word, and in its simplest form, works by using the body’s immune system to engage its war against cancer. The therapy attempts to increase the uptake and absorption of DNA-based treatments directly into the tumor. OncoSec is well on their way to demonstrating best-in-class potential built out by compelling proof-of-concept clinical trials. Data published by ONCS is impressive, showing a 48% BORR (Best Overall Response Rate) in patients diagnosed with immunologically “cold” tumors. “Cold” tumors are those designated as difficult for the body’s immune system to treat on its own, and carries a high likelihood of relapse.

Recognizing its value, immunotherapy is now considered a primary option for tumor treatment, and scientists are looking toward innovative and combination therapies to treat these diseases. To address that need, OncoSec has established its use of electroporation technology to deliver a safe and targeted method of gene transmission. Additionally, ONCS is working to broaden its deliverables by building upon multi-gene plasmid constructs to meet next generation treatment strategies. OncoSec has secured Fast Track Designation from the FDA, and alongside an Orphan Drug Status for additional pipeline candidates, the company sits on the verge of earning an FDA review for accelerated approval for their lead program in 2019. Furthermore, ONCS has in place a drug supply and clinical collaboration agreement with Merck, a globally recognized player in the pharmaceutical industry. Overall, the convincing clinical capability built out by OncoSec may indeed provide them with a sizable advantage amongst competitors in securing a valuable and competitive place in the market.

OncoSec’s Approach Makes A Difference

Although OncoSec may be a relatively small company at the moment, the company’s targeted strategy has allowed them to not only keep pace with their competitors but in several clinical aspects surpasses them, supported by published and compelling clinical data. While most competitors’ programs are still in Phase 1 or 2 studies, OncoSec is now advancing its Phase 2 registration-enabling clinical trials in an expedited manner. Additionally, the company’s projected milestone for treatment approval in early 2019 suggests that OncoSec may further distance themselves from market competitors and emerge as a market leader in targeted cancer treatment, enjoying licensing and partnership opportunities intended to exploit the multi-billion dollar market potential.

Being a disruptor may be an advantage, and the innovative technology within OncoSec’s pipeline is a key factor that sets the company apart from its competitors, potentially leading to ONCS’s ability to alter the course of cancer treatment. OncoSec’s flagship treatment, ImmunoPulse® IL-12, is an innovative, non-viral gene delivery platform designed to utilize the power of the human immune system to target and attack tumors in the body. The non-viral treatment works by introducing a controlled amount of IL-12 in the tumor’s microenvironment, which allows the immune system to recognize the tumor and assemble an army of killer t-cells to eliminate the diseased target. In clinical trials, the ImmunoPulse® IL-12 system was shown to deliver equal gene transmission rates, while maintaining a higher safety profile than other currently available viral and non-viral therapies. ImmunoPulse® IL-12 benefits are proven and validated through multiple human clinical trials across multiple disease types, and as there is no limit on size or number of genes delivered to the patient, the therapy can be specifically targeted to address multiple disease indications. With this advantage, the device carries the opportunity to be the first of its kind on the market, putting OncoSec in a potentially lucrative and enviable position by cementing a landscape for both a strategic and partnership opportunity.

The ImmunoPulse® Effect; A Key Advantage

As stated earlier, the ImmunoPulse® IL-12 system works by delivering a certain amount of IL-12 into the patient’s tumor. IL-12, or Interleukin-12, is a powerful and pro-inflammatory cytokine, and tavokinogene teslaplasmid, or “Tavo,” is a plasmid DNA encoding for IL-12. The process plays out by Tavo getting injected into the microenvironment of the tumor, then delivering the Tavo inside the cells, which in turn secretes the IL-12 inside the tumor. Subsequently, the body’s T-cells can better identify and determine how to fight against the cancerous cells, leading to a proficient anti-tumor response from the body. The intratumoral delivery made possible by the ImmunoPulse® device carries a notably low toxicity level for any immunotherapeutic treatment, making it a safe yet powerful treatment unlike anything currently on the market. Another important feature of the ImmunoPulse® system is its flexibility. The platform allows for precisely-measurable variability in the number of genes delivered to a targeted area, which allows physicians to adjust the treatment to bring out the best possible anti-tumor immune response in patients. Finally, and intrinsically important, is that the device has proven effective in its ability to deliver multiple genes into the tumor simultaneously, which may significantly reduce the likelihood for the tumor to avoid the internal defenses of the body’s immune system after treatment.

And, while industry limitations exist in overcoming the tumors ability to challenge an immune response, the strategy in place by OncoSec, utilizing the ImmunoPulse® platform, aims to target and defeat that limitation. Currently, the majority of patients with solid tumors do not respond to anti-PD-1 therapy, regardless of the cancer type. This occurrence, of course, begs the question: what is causing these patients to not receive any benefit from this kind of therapy? Scientists have found that in general, patients who DO respond to anti-PD-1 therapies have what is known as a “hot” or “inflamed” tumor, meaning that the tumor already has a high expression of PD-L1 in its cells, along with a higher density of tumor-infiltrating lymphocytes. A “hot” tumor is more easily detected by the body’s immune system, thus more responsive to anti-PD-1 therapies, opening the door to OncoSec’s novel technology. Complimented by the ImmunoPulse® platform, interim clinical studies have shown that the ONCS treatment has the potential to convert “cold” tumors to “hot,” actually increasing the patient’s odds of responding positively to anti-PD-1 therapies. During these clinical trials, ImmunoPulse® IL-12 was shown to have a noticeable response in patients that were confirmed to have “cold” tumors. After the treatment regimen, results showed a 48% Best Overall Response Rate (BORR) in patients provided with ImmunoPulse® IL-12 combined with anti-PD-1, proving the value in patients who initially had a lower chance of benefiting from the anti-PD-1 treatment alone. The published data suggests that people who were unable to receive healing treatment are now able to significantly increase their chances at responding to the same therapy after using ImmunoPulse® IL-12. If these test results prove to be durable throughout the upcoming clinical trials, OncoSec could be very well positioned to introduce a lucrative and game-changing cancer treatment technology to a receptive market.

All Signs Point To Yes

Alongside the development of their ImmunoPulse® IL-12 treatment, OncoSec is strategizing on how to best take advantage of the company’s expected developments and market opportunities. Primarily, ONCS has set their target patient population to those with a pathological diagnosis of unresectable or metastatic melanoma (stage III/IV) that fail anti-PD1 therapy. Currently, there are over 10,200 of these patients in the United States that could potentially benefit from ImmunoPulse® IL-12 therapy in combination with anti-PD-1. For example, there are an estimated 9,900 patients currently undergoing anti-PD-1 therapy in the U.S. Of these 9,900 people, around 6,400 have shown poor response rates to anti-PD-1 therapy alone, demonstrating that a significant subset of individuals could receive a tremendous benefit from treatment via the ImmunoPulse® IL-12 platform. And, with over 80,000 new cases of melanoma diagnosed in the U.S. per year, OncoSec’s ImmunoPulse® device, utilizing combination therapies, could prove to be a revolutionary treatment for those who are unresponsive to current procedures. And, researchers within the company have expressed that their early proof-of-concept in melanoma patients indicates a potential for the ImmunoPulse® IL-12 platform to work on other ailments with similar characteristics. For instance, diseases such as triple negative breast cancer and head and neck cancers are known to have accessible tumors, and similar to melanoma, also carry a very high rate of non-response to anti-PD-1 therapy alone. The characteristics of both of these cancers point to a likely possibility of patients responding to the ImmunoPulse® IL-12 platform similarly to how it works in patients with melanoma, and OncoSec has established plans to investigate additional ways of broadening the device’s reach. From the inhibition of a tumor’s immunosuppressive environment to cell signaling and trafficking, OncoSec researchers are already aware of many potential applications of Interleukin-12 delivered through the ImmunoPulse® device, and company management acknowledges that the application’s power may be an extremely profitable opportunity.

Investors will be pleased to know that the market and medical community interest in melanoma and immunotherapy treatments are significant and that a gap in the market is waiting to get filled by a responsive company, like ONCS, who is demonstrating the ability to provide a reliable, safe, and curable treatment to cancer patients. In the past, companies have spent vast sums of money on earlier programs that dealt with the same issues focused on by OncoSec. For example, Amgen’s 2011 acquisition of BioVex demonstrated the proof of interest and need for an effective melanoma treatment. BioVex was a company that had been researching and developing a treatment against melanoma called Imlygic, also known as T-VEC. T-VEC was an oncolytic viral therapy that aimed to promote a similar anti-tumor response to OncoSec’s ImmunoPulse®. The company showed promise, and in 2011, was purchased by Amgen for $1 billion in hopes that the treatment would prove revolutionary. Unfortunately, as additional clinical data continued to become available, it was found that the treatment was not as effective as initially hoped, and as of 2016, there is little evidence that the treatment was able to extend the life of people with melanoma. Additionally, T-VEC was known to cause a myriad of undesirable side effects, including fever, nausea, and other flu-like symptoms in over 30% of those treated. Although the treatment proved unsuccessful, the BioVex deal was still one of the largest deals in the immunotherapy field at the time and signaled a voracious interest in bringing to market a more effective product. And, keeping this goal in mind, OncoSec may hold the potential to provide the treatment that T-VEC was unable to deliver.

ONCS On The Fast-Track

OncoSec, in some respects, is in a similar position to BioVex before their acquisition by Amgen – the company has robust clinical data to date, and as their Phase 2 data continues to unfold, the company is sure to spark the interest of respected players within the biotech industry. Not only has the initial testing of their ImmunoPulse® IL-12 platform brought positive results, but it is also doing so without causing many of the uncomfortable side effects caused by earlier and similar treatments. Additionally, the FDA’s granting of Orphan Drug Status and Fast Track Approval to the company will allow them to more quickly develop and undergo research trials for their products, removing many of the restrictions that may be faced by competitors. Finally, as stated earlier, OncoSec has indicated that their ImmunoPulse® system is likely able to work on multiple tumor types, allowing the company to expand their label across different kinds of diseases, rather than simply melanoma.

As for what’s currently in store for OncoSec, the company plans to initiate their enrollment for a phase 2 trial and collaboration with Merck, referred to as PISCES, by the end of 2017. The company also intends to hold an End of Phase 2 (EOP2) meeting with the FDA during the 1H of 2018, which is anticipated to grant ONCS with an accelerated approval path for anti-PD-1 non-responders in melanoma, along with an approval of their plans for phase 3 trials. This phase 3 confirmatory study is expected to run throughout 2018 and carry on into late 2019, where the company has set milestone goals to obtain a marketing authorization to penetrate a market in need of a viable and responsive cancer treatment.

OncoSec may be considered by some to be a small company, but what can’t get overlooked is that they have built an enviable foundation and scientific infrastructure. And, from a position of clinical strength, ONCS may be ideally placed to reap enormous benefit from the development of their promising immunotherapy treatment system. If ImmunoPulse® IL_12, with combination therapy, continues to deliver positive results, OncoSec may very well be the company the market has been waiting to embrace, providing game-changing cancer treating technology that may alter the therapeutic landscape and fill a void to address unmet medical needs.

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. Worldwide Holdings paid CNA Finance $3,000 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Oncosec Medical Inc. by CNA Finance. All information researched and provided through any article associated with Oncosec Medical Inc. 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.

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...