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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.

Aytu BioScience AYTU Stock News

Both Aytu BioScience and Lipocine, Inc. are advancing novel testosterone replacement therapies, but when placed side by side, which stock may make investors pumped for joy?

As of today, the testosterone replacement therapy market is a hot sector, with companies focused on grabbing as much of the estimated $2 billion market as they can. Two emerging companies, in particular, are focused on delivering shareholders both near and long-term value propositions by advancing their unique TRT products, one of which has recently hit the market. And, while several large pharmaceuticals are well entrenched in the TRT market already, their products, like AndroGel (ABBV), Axiron (LLY), and Fortesta (ENDP), are plagued with the most severe of FDA warnings, the dreaded Black Box warning. Thus, with the market opportunity open to treatments that may provide a better solution without the known risks of currently marketed TRT products, let’s place two peer competitors side by side to determine the chances of either of the two taking a bite out of the current market potential.

Is Aytu BioScience The “Wise Choice?”

Although AYTU has experienced a tough month in August, likely attributable to the recent capital raise, the company has never been stronger from a clinical and marketing perspective. Now, that the split is old news and with shares trading above $3.70 per share, the distractions of the past month may soon get replaced with investor optimism about the company’s lead TRT product, Natesto.

Natesto has the potential to become a game changer in the TRT market. Although AYTU is marketing with a much smaller budget than those with already approved therapies on the market, at some point investors believe that wisdom will soon replace big pharma muscle, making Natesto the TRT of choice for prescribing physicians. And, when looking at published clinical data, the case for a market leading Natesto should not be cast off as pure fodder. In fact, when comparing Natesto to Lipocine’s pipeline TRT, Tlando, as well as to a host of other big name drugs, Natesto has demonstrated statistically better efficacy and appears to be a safer and more effective treatment than most all TRT products currently on the market.

Keeping the focus only on both company’s TRT products, other promising AYTU pipeline products won’t get considered. However, investors should not discount the value inherent to the AYTU pipeline consisting of a male infertility product MiOXSYS and a female sexual wellness product Fiera, and like Natesto may offer significant and compelling market advantages. Okay, so what about Natesto’s bid to be best-in-class?

First off, Natesto is the only nasally administered TRT on the market. And, while some investors may not understand the significance of that issue, users of the product will. Being nasally administered helps to alleviate inadvertent transfer of testosterone, provides consistent and efficient dosing, and offers significant convenience over topically applied products. And, because of these advantages, Natesto is the only currently marketed FDA approved topical TRT product not labeled with the severe FDA required Black Box warning. However, those safety and convenience issues are just the tip of the iceberg in the advantages column; there is more to Natesto to justify its place in the $2 billion TRT market.

It’s no accident that Natesto has been called the potential best-in-class therapy on the market. Coming off of its recent spike of over 300% in new prescription volume, Natesto is grabbing the attention of physicians due to the proven effectiveness of the product, which also leaves behind the severe side effects for patients. The differentiating factors are apparent, Natesto reduces or eliminates the potential for accidental transfer and does not require a man taking the product to quarantine himself from a female or child to quarantine while the product is applied. Additionally, being a hand’s free application, Natesto offers consistent dosing in a measured treatment, and that’s an important issue since excessive intake of testosterone is not necessarily a good thing for patients. Of perhaps higher importance, though, is that Natesto does not significantly reduce levels of LH and FSH hormones in the body, which has caused side effects in patients (including reducing sperm count and decreasing testicle size) that use products like AndroGel, Axiron, Fortesta, and injectable products. Not only does Natesto maintain proper hormone levels in patients, but Natesto also eliminates the potential for users getting hooked on testosterone treatments to maintain healthy testosterone levels. Natesto excels in other areas of concern as well, demonstrating a better safety profile over long-acting gels and injections that have been shown to increase hematocrit concentrations in the patient. That is, the treatments make the patient’s blood thicker, which may lead to stroke and cardiac-related complications in patients. From a safety perspective, Natesto is best-in-class, but what about the efficacy?

The safety profile is significant, but it’s how Natesto performs that is the real story. Marketed as “testosterone in seconds,” Natesto is now the first and only FDA-approved intranasal TRT on the market. In a clinical trial, the majority of patients achieved statistically significant improvement in each of the five domains of erectile function. In most cases, the effect on normalizing erectile function occurred within the first thirty days of treatment. In addition to the benefits mentioned, 70% of men in the Natesto pivotal trial said they would switch from their current TRT to treatment with Natesto. Thus, no surprise that Natesto has seen a sharp trend higher in new prescription rates, with new authorizations for the product doubling since May of 2017. Also, 90% of men taking Natesto get their testosterone levels back to ‘normal,’ which is higher than other TRTs. And most men taking Natesto see their moods improve as soon as thirty days from starting treatment. The market is estimated to stand at approximately $2 billion currently, and if AYTU maintains the current trend, even a 10% market penetration can return over $200 million in new revenues.

Now that AYTU has roughly only four million shares outstanding, a revenue spike of that magnitude would most likely cause a disproportionate rise higher in company market cap, which currently reflects anemic value considering this potentially game-changing product. Adding in the potential of Aytu’s other marketed products, the company may be a very wise choice for investors seeking long-term value and probability for share price appreciation.

Is Lipocine, Inc. The “Wise Choice?”

Lipocince, Inc. (LPCN) is developing a testosterone product called Tlando. Although the product is not yet on the market, LPCN is the closest peer to Aytu from a market perspective. LPCN is taking a different approach for Tlando, testing an orally administered dose of testosterone, which the company plans to submit to the FDA for approval in the coming months. Importantly, investors need to know that the FDA has already denied the application for Tlando once, but LPCN is preparing to try for approval once again, relying on similar data from the original rejected application.

A potential drawback for the oral administration of Tlando, is that patients will be required to keep a consistent diet, maintaining certain fat content and calorie intake. And, this is the case for each dosing. If patients fail to adhere to specific dietary requirements, patients are unlikely to see a meaningful rise in testosterone levels, which would be a huge problem and a potential marketing nightmare for the product. A significantly more adverse scenario is that during the company’s FDA studies, a handful of men reached testosterone levels of over 2500 ng/dl, which is both extremely high and dangerous.

In addition to potential FDA problems looming for Tlando, the company itself said in a press release that LPCN 1021 (Tlando) only “generally met” the pre-specified per dose secondary endpoints for twice daily oral administration. In layman’s terms, the product either meets the endpoint, or it doesn’t, and when the company itself publishes mixed messages, investors should pay close attention. Also important to note is that the FDA will be highly unappeased if men being treated by Tlando exceed the 2500 ng/dl level, making the chances for approval unlikely. And to add insult to potential misery, as far as the FDA is concerned, when endpoints are “generally met,” product support is unlikely. Their word’s, not mine.

The biggest issue for Tlando compared to Natesto, though, is that when placed side by side, Tlando does not get as many men to normal testosterone levels. Company sponsored studies demonstrate a significant edge in benefit from Natesto, with 90% of males reaching normal testosterone levels, compared to just 70% of patients reaching normal testosterone levels when using Tlando. The FDA has made it known that at least 75% of men taking the testosterone product must reach normal T levels, so it is difficult to understand how the FDA would even approve Tlando. Additionally, with Tlando known to produce dangerously high testosterone concentrations in some men, the road to approval may be far tougher than even the most optimistic investor may be willing to admit.

The “Wisest Choice?”

Comparing the two, AYTU emerges as a clear “wise choice” for investors wanting exposure to the multi-billion dollar TRT market. Interestingly, LPCN has a current market cap of roughly $75 million compared to Aytu’s approximately $15 million market cap. From both a product and valuation standpoint, the opportunity for growth is substantial in the Aytu BioScience camp, particularly when you consider that there is no regulatory risk for Ayu. The product is already on the market and growing rapidly. Although a slim chance exists for approval for Tlando, the product would most likely get met with considerable marketing difficulties. Conversely, with Aytu’s Natesto already approved and marketed, the promise again lay squarely in the Aytu potential.

Now that the TRT comparisons are noted, it’s fair to factor in both AYTU’s and LPCN’s additional pipeline opportunities. While a slight opportunity may have existed for LPCN to present itself in a better light, the company is yet to produce an impressive clinical statistic. Thus, the clear advantages still weigh heavily in Aytu’s favor, solidifying their position as the better of the two. With a pipeline focused on making use of a combined market opportunity of more than $11 million dollars in the bank following their recent capital raise, in this case, Aytu BioScience is the superior choice for investors looking to “choose wisely.”

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Aytu BioScience AYTU Stock News

For those paying attention, it’s evident that the Aytu Bioscience pipeline is going through a major growth spurt. And, while Aytu’s, Natesto, has been garnering a substantial portion of the sales and marketing focus, the company’s additional products, MiOXSYS and Fiera may prove to become just as valuable to future revenue streams. And, if sales mimic Natesto, who has seen its revenue ramp by over 400% during the past two-quarters, the future for AYTU may soon align in shareholders favor.

With both Natesto and MiOXSYS now receiving generous market coverage and analysis, the third product in the AYTU pipeline, Fiera, may be next to enjoy both investor and consumer interest as details of this drug-free, revolutionary female sexual dysfunction treatment makes its way to a global market. Fiera, for those new to AYTU, is a hands-free, wearable product designed for women to increase sexual interest, arousal, and perhaps most importantly, target and treat female sexual dysfunction (SD) issues.

Fiera: A Women’s New Best Friend?

Like Natesto and MiOXSYS, Fiera is looking to take advantage of a growing opportunity in the sexual dysfunction and treatment market. And, why not. In the U.S sexual wellness market alone, which is estimated to reach $9.75 billion in value by 2020, significant opportunities abound, and AYTU is aiming for the sweet spot in several differentiated SD markets.

Alongside big names like Viagra or Cialis, there exist a myriad of products, drugs, and treatments designed for the improvement of men’s sex lives, but the market is currently lacking in new and innovative products intended for women. Aytu wants to fill that gap, targeting the estimated 45% of women worldwide that report sexual dysfunction issues, with symptoms that include a lowered sex drive to difficulties with arousal. As is the case for most health and personal care matters, there are a handful of drugs on the market that aim to treat specific diagnosed problems. But, what if these problems could be drastically improved, without the use of a drug? Well, that is precisely what the Fiera device plans to do.

Aytu Bioscience’s, Fiera Personal Care Device, is the industry’s first hands-free wearable product for women and is designed to increase female interest and readiness for sexual activity naturally, without the use of any drugs. With initial testing showing remarkably positive results, Fiera could very likely revolutionize the way female sexual dysfunction gets treated.

Fiera Is A Natural Alternative

The Fiera device is unique and has been clinically proven to increase sexual desire and arousal through natural stimulation. Fiera’s design as an external, hands-free device makes it an appealing option for many women who are rightfully wary of taking a prescribed medication to combat the SD issue, which can cause unwanted side effects. The product was created by collaborating with numerous healthcare and sexual wellness professionals and is designed to discreetly and quickly help women overcome problems with sexual dysfunction. At its core, Fiera aims to work for women similar to how Viagra works for men: increasing blood flow to the genitals. To do so, Fiera works by using gentle suction and stimulation in such a way that enhances a women’s blood flow, lubrication, and overall readiness for sexual intimacy. Since its development, Fiera has undergone numerous clinical tests by health care professionals and consumers alike, and its scientifically-based design has already proven to be effective in the vast majority of users, including both pre and post-menopausal women. In a study in which women aged 25-75 used Fiera for four weeks, 97% of the participants reported that they felt more physically aroused, and 93% indicated that the device helped them to feel more “in the mood” for sexual intimacy. Also, 87% of participants reported feeling as ready for sex as their partner did, and 96% said they were once again able to look forward to and feel excited about sexual intercourse. Notably, studies have also shown that Fiera can help women achieve arousal in an average of only five minutes of use. Overall, consumers indicate in the vast majority of cases that Fiera is fast-acting, discreet, and most of all, effective. Not only does Fiera work, but the discreet, hands-free use of the device is another big selling point of the product. Many women may feel uncomfortable purchasing any product that addresses sexual activity or function, and Fiera’s subtle design and quick effect work to minimize the hesitation that a woman might have with purchasing other products in the market. Additionally, Fiera can be bought online or through a doctor’s office, which allows for the easy and private ownership of the product.

The Blossoming Female Sexual Dysfunction Industry

To date, studies have shown Fiera to be extremely effective in accomplishing its intentions. But, for investors, understanding how AYTU can monetize the Fiera opportunity remains a leading issue. Well, as stated earlier, the U.S. sexual wellness industry is estimated to reach over $9.75 billion in market value by 2020. There is significant money to be made by new and innovative products within the market space, and Fiera hits both of those marks. Investors can track the recent activity by leading companies within the sexual wellness market to get an idea of the lucrative potential Fiera could bring. For instance, Hologic, a leader in women’s health products, recently acquired Cynosure, Inc for an approximate $1.65 billion. Also, the company that developed Addyi, often referred to as the “female Viagra,” was recently purchased by Valeant for approximately $1 billion, along with a share of the drug’s future profits. Following a potentially similar course, Fiera was originally developed by Nuelle, a company that recognized an opportunity in partnering with Aytu given AYTU’s company’s strong portfolio of male sexual wellness products, namely Natesto and MiOXSYS. However, Aytu quickly realized the compelling clinical data and revolutionary potential of Nuelle’s Fiera device, and decided to acquire Nuelle in an all-stock transaction. Before Nuelle’s acquisition by Aytu, Fiera was not the focus of any major marketing campaigns, and marketing efforts remained confined to a select number of sexual wellness physicians and online markets. Now, with the acquisition complete, Aytu has begun the initial phases of integrating Fiera into its sales force, which should give the device the push it needs to gain traction and sales momentum in the market. And, a product as unique and effective as Fiera brings with it great potential to catch the attention of consumers and industry leaders alike, making the device a very welcome addition to Aytu’s portfolio of products.

Arousing The Female Market

From a product perspective, the expertly crafted Fiera Personal Care Device has everything going for it: sleek, unobtrusive design, a natural and drug-free method of acting, and most of all, a clinically proven woman-centered product. Now that Fiera is in the hands of AYTU, the management team is working to raise awareness of this potential game-changer. The results are already emerging, and a successful marketing campaign could be the only thing Fiera needs to achieve mainstream status. The product’s design makes it a safe and appealing option for women who wish to improve their sexual wellness, especially those who would rather refrain from taking modestly effective drugs that carry the risk of side effects. Fiera could be the answer that millions of women have searched for, and has the potential to bring in significant revenue opportunity for Aytu. Sitting alongside Aytu Bioscience’s catalog of unique and similarly lucrative male products, Fiera is the perfect complement to the company’s portfolio.

Now that AYTU is flush with cash, perhaps enough to drive the company to profitability, investors may be wise to focus on the pipeline opportunities rather than short term strategic initiatives that are intended to benefit investors for the long term. Having a new share structure, three promising products, and a focus on a multi-billion dollar market potential should outweigh any reserved sentiment regarding the pending capital restructure. When all is said and done, AYTU, with over $10 million in the bank and an adjusted share count of fewer than five million shares, the company may very well be in a position to arouse investor interest and capitalize on significant market opportunities. For those that are willing to take a position and allow AYTU to develop its promising pipeline of products, the probability of earning both near and long-term. success may prove likely, keeping investors satisfied for many years to come.

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 paid CNA Finance $4,000 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.

Aytu BioScience AYTU Stock News

Aytu BioScience’s’s today announced that the company had completed its shareholder approved reverse split, taking the effective share count down to approximately 4.0 million shares from its former outstanding share total of 80.4 million shares. Aytu BioScience intends for this strategic initiative to assist in its drive to gain a listing on a senior stock exchange. For the next 20 trading days, AYTU will trade under the symbol “AYTUD,” and after the 20-day period will resume trading under its original symbol “AYTU.”

Strategic Intent To Up-list to a Senior Exchange

Shareholders in AYTU have been met with positive news in recent weeks, although the share price may not be telling the right story to investors. As reported by the company on its corporate website, AYTU has seen prescription levels for its lead product, Natesto, rise substantially during the previous two-quarters. In addition to the increase in Natesto prescription volumes, the company recently raised in excess of $11 million in a private placement with accredited investors.

Although the share price has endured pressure most likely due to the overhang of the planned reverse split, investors can now replace uncertainty with a renewed focus on the developments underway at the company.

Not only is Natesto delivering robust prescription growth rate performance, but AYTU’s two other pipeline products are also positioned to gain traction from the company’s increasing focus on the sales and marketing of MiOXSYS and Fiera, two products that address reproductive and sexual dysfunction issues in both the male and female markets, respectively.

Strategic Products Gaining Market Share

Natesto, the company’s lead product is an FDA approved testosterone replacement therapy. Notably, Natesto is the only nasally administered TRT in the market, and clinical results demonstrate that the product may soon be a best-in-class alternative over competing products. Importantly, Natesto is the ONLY testosterone replacement therapy available on the market that does not include an FDA mandated Black Box warning, which represents one of the most severe warning labels imposed by the FDA. Natesto has been proven safe, effective, convenient, and easy to use on a regular basis. Since April of 2017, Natesto prescription levels have risen by over 300%, and the company has finally worked through previous inventory levels sold to customers by Endo Pharmaceuticals before Aytu’s licensing of the product in 2016.

MiOXSYS is also expected to gain traction, with AYTU providing additional sales and marketing efforts to capitalize on this $11 billion market opportunity that addresses male infertility. Similar to Natesto, MiOXSYS holds best-in-class potential, providing physicians or trained technicians with the ability to offer advanced in-office fertility screening. The MiOXSYS panel of results does in minutes what has traditionally taken days for competitive products to produce.

Finally, AYTU is taking a stronger interest in marketing Fiera, a revolutionary, hands-free and drug-free option for women enduring sexual arousal issues. Fiera has shown sequential growth rates in sales recently, despite only being marketed online. Fiera has a CE marking in place and is in a position to capitalize on the EU markets, with plans to launch via Aytu’s sales force in the United States within the next six months. The Fiera device was purchased in an all-stock transaction from Nuelle, Inc. in May of 2017. The acquisition provides AYTU with a novel, commercial-stage product that is delivering revenue to the company. The potential addressable market in the female sexual dysfunction space is expected to exceed $3 billion by 2020 and target an estimated 50 million female patients during that same period.

Aytu Invigorated

With Aytu BioScience’s emerging with a restructured share count and a strong balance sheet, investors may be wise to pay attention to the company’s revenue producing pipeline, and pay less attention to the pressures put on the stock for reasons other than product performance.

Although shares have been beaten down during the prior month, the intrinsic value within AYTU has been growing in counter-measure to the stock price. Keeping an eye on the long-term potential at AYTU should take center stage in the near term, and investors should allow time for the strategic vision to materialize. The balance sheet is strong, and the company has guided toward profitability within the next twelve months. Despite the current beat down, AYTU at these adjusted levels is a potential gift to investors who have the stomach for volatility, but at the same time recognize both near and long-term potential.

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 paid CNA Finance $4,000 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.

Portage Biotech PTGEF Stock News

Okay, so you want a tip on an undervalued stock? Then, focus your attention no further than to Portage Biotech (PTGEF). Now that I have you concentrating, the first step is to do the math and understand that tiny Portage Biotech owns 6,341,500 shares of a company named Biohaven Pharmaceutical Holding Company Ltd. (BHVN), a NYSE stock that closed on Monday at $37.54 a share. Now, to put that in perspective, PTGEF, which closed at just .47 cents on Monday, has equity in BHVN of roughly $238,059,910! Yes, that’s correct, at Monday’s close, PTGEF had around $238 million in BHVN equity, representing approximately .85 cents per share on a cash basis to Portage.

So, to make sense of it all, this tiny little company, thanks to an exceptional management team that took a roughly $7 million dollar investment and turned it into $238 million, PTGEF investors may be in line for a significant payday. Not too bad no matter how it’s measured. In fact, it was an extraordinary feat of managerial expertise. And, because PTGEF trades well under most investors radar screen’s, the secret is still a matter of fact to most.

What The…

Now, the ultimate value of BHVN stock to Portage is still an undervalued asset, with PTGEF shares trading at roughly 57% of its BHVN holdings. And, if that lapse of market reason does not scrape the cro-magnum knuckles, there is additional value in PTGEF through its two wholly owned companies, Portage Pharmaceuticals, and Sentien Biotechnologies, Incorporated. Although both of these assets are just now emerging, the value is certainly more than zero.

The value and distribution proposition that may be recognized from an investment in PTGEF is not far off, by the way. And, to be sure, much of the value that investors may expect to receive sits in BHVN, with a couple of potnetial scenarios playing out. Of course, much of the final distributive value rests in the price of BHVN at the time of dividend or amalgamation. But, with BHVN shares continuing to run higher with solid clinical prospects, investors may reasonably expect that BHVN management will continue to accelerate its own prospects to maintain its momentum to the upside.

How Will The Deal Go Down?

For investors to realize the value in the BHVN holdings, either of two scenarios is expected. First, PTGEF management sells its stake in BHVN and offers a cash dividend to holders of record of PTGEF stock on a particular record date. At current prices, the dividend would be roughly .85 cents based on BHVN shares held divided by a fully diluted share count at Portage of approximately 277 million shares. Certainly, that potential dividend may rise or fall with market conditions.

However, most investors see a different scenario playing out. A more likely event would be for BHVN to absorb PTGEF, which has close ties to current and former management. Keep in mind, BHVN was spun out of PTGEF, so the relationships are strong. If this scenario plays out, PTGEF shareholders may get a substantial reward by getting shares in BHVN with a value far higher than current PTGEF stock prices, and at today’s valuations would bring roughly a 74% premium. Although shareholders may give up their PTGEF shares in exchange for BHVN shares, holding shares in an emerging company who has several phase 2/3 trials in progress is a fine opportunity for current PTGEF shareholders, and most shareholders appear ready to accept those terms, if such an offer is presented.

While I could go on a rampage as to why BHVN, in and of itself, is a fantastic long-term stock to own, my thesis remains simple. PTGEF, at these levels, is a screaming buy, with more value being left out of the stock than is currently factored INTO the stock. Although there is never a sure thing in the capital markets, this deal may be the closest an investor may come to being provided with a likely 70% gain in less than three months time, which is when a decision on how to distribute the BHVN wealth is expected to be made.

Full disclosure, I’m long the stock and getting longer by the day. And, although PTGEF share prices may likely continue to rise from investors taking advantage of the emerging value opportunity, consider this tip a friendly gift from me to you. For those that have followed the story, many both recognized and praised the potential in PTGEF back when it traded at .12 cents a share. To all of those investors, I say…”we done good.”

Disclosure: This article was written by Kenny Soulstring, and it reflects my own opinions and unique articulation. This article is not intended to offer investing advice, guarantee 100% accurate predictions or to be interpreted as providing a personal recommendation. What I can guarantee, though, is accurate research, thoughtful analysis and an enthusiasm about any stock that I cover.

While I seek to uncover emerging companies that I feel have true value and potential, it’s important that investors assign an appropriate time horizon to each of their investments, understanding that emerging companies need time to mature.

I wrote this article myself and it includes my own research and expresses my own opinions. I am not receiving compensation for it (other than from CNA Finance). I have no business relationship with any company whose stock is mentioned in this article.

Additional Disclosure: I am LONG PTGEF and may add to any positions within the next 72 hours.

Youngevity International YGYID Stock News

We’ve been following Youngevity International for quite some time now, and for good reason. Since the company was brought to our attention, we’ve seen consistent news, and that news has been overwhelmingly positive. With so much coming out over the past few months, we figured that now would be a good time to go back and provide a bit of a recap with regard to what we’ve seen from YGYI over recent months.

June 21st YGYI Hits The NASDAQ!

We started covering Youngevity shortly before they made it to the NASDAQ. On June 21st, the company was uplisted. The day before the uplist, the company announced the biggest acquisition it had been part of to date. On June 20th, YGYI announced that it had entered into a definitive agreement to acquire Sorvana International, bringing on the FreeLife and L’dara brands.

With regard to the uplist to the NASDAQ, Steve Wallach, CEO and Co-founder of YGYI, had the following to offer:

Youngevity’s listing on the NASDAQ Capital Market is a major corporate milestone and a source of great pride for the Youngevity family of employees, distributors, executives and supporters that have contributed to this moment. What enhances the sense of pride and accomplishment is that Youngevity attains this listing by executing and delivering on our business plan and our priority to grow shareholder value with minimal dilution. We are happy to say that meeting NASDAQ’s requirements is a culmination of the dedication and hard work of so many throughout the Youngevity family.”

With regard to the acquisition of Sorvana International, Mr. Wallach stated:

FreeLife has a proud 22 year history of success in the Direct Selling Profession and L’dara’s patented skin care products are very special. We believe acquiring Sorvana International represents a true expansion of our mission of betterment, and delivering exceptional, science based wellness products for optimal health to our customers… We are very proud of this acquisition as it represents our largest transaction in terms of top line revenue and in numbers of quality field leadership.”

June 29th Pürmeric™ Debut Is Announced

On June 29th, YGYI announced the debut of Pürmeric™, the newest product in the ProLine collection. Pürmeric™ consists of 95% curcuminoids from certified turmeric root and is believed to to deliver a greater antioxidant capacity than most turmeric products on the market today. In a statement, Dave Briskie, President and CFO at Youngevity International, had the following to offer with regard to the debut:

Pürmeric delivers yet another example of our commitment to offering quality and science when we create a nutritional product or supplement… We are not in the business of offering ‘me-too’ products. We are in the business of offering robust product entries that can compete strongly across the supplement spectrum.”

July 10th YGYI Announces Completion Of Sorvana International Acquisition

Following up on the news that was released in late June, Youngevity announced on July 10th that it had completed the acquisition of all assets of Sorvana International. This was incredible news, as this acquisition completion brought on key assets from a company that has a 22-year successful run in the wellness industry, while bringing in key skincare products from a company that has seen incredible success since 2013. In a statement with regard to this news, Steve Wallach offered the following:

We are very proud of having closed on the acquisition of Sorvana International. Sorvana embodies so many of the attributes we look for in an acquisition, ranging from the level of quality products, the amount of distributors and customers, and the geographic footprint the company currently has in the marketplace. We have been seeking to acquire an established company with international distribution and we are very fortunate to have find that opportunity in Sorvana.”

July 12th YGYI Announces The Launch Of Snap2Finish

In July, the news kept rolling as Youngevity International announced the launch of Snap2Finish, it’s break into the $16.8 billion industry that is known as the photo printing and merchandise industry. Snap2Finish gives users the ability to turn their favorite pictures into a variety of gifts and products. With everything from beach towels to coffee mugs and photobooks being offered, Snap2Finish has the ability to be a key driver of revenue ahead. In a statement, Dave Briskie, President and CFO at YGYI, had the following to offer with regard to this news:

We are proud to launch Snap2Finish today and happy to offer another product category to our distributors that they can now bring to their customers… We are enthusiastic about our partnership with Fuji and quite pleased with the quality they are bringing to our Snap2Finish technology. We anticipate expanding these capabilities to our Australia and New Zealand markets later this year.”

July 25th Luke Taffuri Is Brought Onto The Team

On July 25th, more news broke as YGYI made a key addition to its management team. The company announced that it had appointed Luke Taffuri to the position of VP of International Sales and Operations. This is a key addition, as Mr. Taffuri brings more than 22 years of direct selling experience and held the position of COO at Sorvana International, a company that was recently acquired by Youngevity International. In a statement about the appointment, Mr. Taffuri had the following to offer:

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

August 3rd Alliance With Ascaso Announced

Early this month, YGYI kept the news coming when it announced that CLR Roasters, its wholly-owned subsidiary, entered into an alliance with Ascaso. This alliance gave CLR Roasters exclusive distribution rights with regard to Ascaso’s Espresso Equipment for the Food Service market in South Florida. On the same day, the company announced that Café La Rica, A CLR Roasters product, became the Official Cafecito of the Miami Marlins. In a statement regarding the news, Ernesto Aguila, President of CLR Roasters and founder of the Café La Rica brand, offered up the following:

We are proud to now exclusively provide Ascaso Expresso Equipment alongside our As Café La Rica espresso in the food service market. In my opinion, there is no better espresso equipment available in the market today and we expect this competitive advantage to continue to drive the momentum of Café La Rica as we move toward national distribution.”

August 10th YGYI Announces Impressive Earnings Results

Finally, on August 10th, YGYI announced its financial results for the most recent quarter. During the quarter, revenue rose by $2.8 million compared to the first quarter of the year, direct selling revenue increased by 6.9% over Q1, coffee segment revenues rose by 9.1%, and EBITDA came n at $745 thousand for the quarter, a sizable improvement over the loss of $1.24 million seen in the first quarter. In a statement, Dave Briskie had the following to offer with regard to these results:

Following the fourth quarter of 2016 and the first quarter of 2017 which we felt were lackluster our executive team has refocused and increased its commitment toward driving consolidated revenue growth, strengthening our adjusted EBITDA, accelerating our international sales, and driving top line revenue growth for our coffee segment. In the second quarter, we made solid progress in each of these key metrics and we will be measuring our performance in these areas in the coming quarters with an expectation of continued progress for the remainder of 2017 and into 2018.”

Final Thoughts

Youngevity International has been an interesting company to follow. With the company making big moves quite consistently to further take control of the direct selling market, bring new products to the table, and offer growth in key financial data, it’s hard not to keep a close eye and wonder just what’s going to happen next!

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. Youngevity International pays CNA Finance $1,500 per month for research and writing services as well as other investor relations services provided to Youngevity International by CNA Finance. All information researched and provided through any article associated with Youngevity International 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.

Taking a company down to its core often reveals the real value that has yet to be recognized by investors. Despite whether a company trades at ten cents or ten dollars, the real indicator of value lay within the management team, the products or services offered, and, of course, the market that the firm places its focus. For investors in Advanced Medical Isotope Corporation (ADMD), the current share price hardly reflects the underlying value already a part of the company. And, the markets are being even less than conscious of the strong management team, and especially of the fact that ADMD’s lead product has qualified for FDA approval as a medical device, shaving time off the standard FDA approval process which may lead to ADMD securing an expedited pathway to potential profitability.

Currently sitting at roughly ten cents a share, investors that are not familiar with the ADMD story should take a look at the opportunity, recognizing the hidden value and perhaps acting upon an opportunity to invest into the company at depressed share prices. Shares have traded sharply higher, by the way, trading up toward the one-dollar range before pulling back on news of a pending reverse split as a strategic option to gain a national listing on either the NASDAQ or NYSE markets. But, with that said, a reverse split, although not often embraced by retail investors, appears to be masking the underlying value in ADMD. Furthermore, if an investment decision is to be made on the merits of a company, and not its share structure, an opportunity now presents itself to purchase shares at close to 52-week lows.

But, despite trading at the near low’s of the year, which often produce a bullish pattern to emerge on a technical basis, investors would be wise to consider the entire ADMD package to evaluate why the investment thesis would play well into their micro-cap, aggressive based stock portfolio. From an investment perspective, it makes far greater sense to scrutinize a company, rather than to allow the share price to dictate a thesis.

Advanced Medical Isotope Advances Brachytherapy

Drilling into the value drivers in place at ADMD, current investors will recognize the company’s focused efforts to treat animal patients, and eventually human patients, with a medical device currently in late-stage development to treat medical and veterinary cancer treatment applications. For new investors, it’s called RadioGel® brachytherapy, which is a fancy term that describes the treatment of cancer by the insertion of radioactive implants directly into the tissue, either inside of or next to the treatment area. With the RadioGel® brachytherapy procedure now getting FDA evaluation as a device, the FDA classification can save millions of dollars and will shorten the application process significantly compared to a new drug application. In fact, while most New Drug Applications average almost 12 years before approval, medical device products take, on average, less than four years to get to market.

Classified as a medical device, which is expected to eliminate a substantial portion of FDA red-tape, ADMD is working with universities, national labs, and private corporations to deliver on its goal to get the device cleared for human applications within the next three years. With a late August 2017 meeting planned with the FDA to map out the process and timeline for expected approval, the road to adoption is in progress. Bolstered by a substantial amount of data already in hand, and with an experienced management team and medical advisory board in place to assist in expediting the process, ADMD is looking to persuade the FDA through research and accumulated data that the device will meet the threshold to treat multiple cancer indications effectively. While working toward FDA approval, ADMD remains focused on taking advantage of the veterinary side of the device to deliver near-term revenue and to negotiate strategic licensing opportunities in the international markets.

The ADMD mission is clear, provide to the markets a novel therapeutic tool for the treatment of cancers in humans and animals, which essentially offers a new instrument in the treatment toolbox that may take advantage of emerging science to quickly and efficiently combat multiple cancer indications.

RadioGel® Technology Platform

With ADMD advancing its patent protected, proprietary radiopharmaceutical device, ADMD’s next generation RadioGel® platform is a therapeutic device to deliver a hydrogel treatment to an indicated area. ADMD’s approach is to provide a minimal particle treatment, using Yttrium-90 phosphate. These particles are imbedded in a hydrogel which solidifies at body temperature after injection and perfuses within the targeted tumor. The use of Yttrium-90 is part of the ADMD “secret sauce,” because of its value to deliver a significantly high dose of beta energy emitters into the target area. Beyond the strength and benefit of localized treatment, the Yttrium-90 phosphate may become the preferred method of therapy since it causes the radiation to travel only a very short distance, with minimal collateral damage to healthy tissue located outside of the targeted region. Even more important, and perhaps a key component to the potential marketability of the device is that the RadioGel® treatment has only a 2.7-day half-life, with only 5% of the radiation treatment remaining in the patient after a ten-day period.

Keep in mind, that for now, the patients will be veterinary based, targeting a market of over 165 million cats and dogs in just the United States. In the veterinary market alone, there is a potential market to treat the over 20 million combined cases of animal cancer, the leading cause of death for cats and dogs. Testing for veterinary use, ADMD has assembled a prestigious team of researchers, with research being conducted by a respectable group of universities, inclusive of Washington State University, University of Missouri, UC Davis, and Colorado State University, with the company’s IsoPet® treatment the focus of the study.

IsoPet® may represent the nearest contributor to expected revenue, with the goal for ADMD to record income in early 2018. With confirmation studies in place to register the device useful for treating animals, ADMD is targeting the potential $40 million animal cancer market, a revenue number achieved by amassing just a 10% penetration into the total available market at a cost per treatment of roughly $5,000 per case.

Now that the initial market is recognized as the leading application to drive near-term revenue, ADMD is entering later-stage processes to obtain approval, to demonstrate the therapies at leading research institutions, and to begin direct sales to private clinics throughout the United States.

IsoPet® Only Opens The Marketability of RadioGel®

Although the applications and revenue potential in targeting the veterinary side of the RadioGel® therapy are vast, ADMD remains keenly focused on bringing this innovative technology to the human cancer market. Already working with a respected medical advisory board, with input from Mayo Clinic doctors, ADMD is taking its combined 125 years of medical experience and applying it directly toward device approval. The path to commercialization is expected to include international partnerships, the development of strict manufacturing processes, and strategic marketing initiatives to target global marketability and opportunity.

ADMD is not holding back from receiving criticism, either. To the contrary, ADMD management sought input from several industry experts to define the most immediate and beneficial uses for RadioGel® technology. Through research, consultation, and an emerging set of compelling data points, the expanded exploratory team concluded that the most accretive value driver would be to target Basel Cell and Squamous Cell skin cancers, with an additional 17 cancers identified as potential beneficiaries of the treatment.

For ADMD, the skin cancer market may be substantial, with one out of every three newly diagnosed cancers now associated with the skin. In the United States alone, over 4.5 million cases (PS in 3.3 patients) of combined skin cancers are reported each year, with over 4 million Basel Cell cases, whereby tumors position in the deepest layer of the epidermis. The other 1 million cases get comprised of mostly Squamous Cell carcinomas, which are skin cancers located in the upper layers of the epidermis. Thus, with a market that is well-defined and is increasing on a yearly basis, the opportunity for ADMD in that particular cancer indication may become substantial.

Assuming that an FDA supported RadioGel® device to target just skin cancer is approved, international licensing agreements hold the potential to deliver roughly $1.5 billion in annual revenues, assuming a $5,000 cost of treatment and treating just 10% of the 3.3 million patients. And, as referenced, the international markets may serve to expedite the revenue-generating process, with the potential of global license deals generating income in early 2018. But, having a potentially transformational treatment device is only part of the process, and ADMD understands that they must have their regulatory pathway well defined to gain approval.

Gaining Both Favor and Approval

Now that major university studies are validating the RadioGel® therapy through the brachytherapy process, ADMD is equally focused on committing the resources required to support ultimate approval. With an FDA that strictly scrutinizes not only drug or treatment approval, but places equal importance on manufacturing processes, ADMD is working to ensure the regulatory guidelines are met or exceeded. With production optimization now complete, ADMD has set in place the proprietary process to cost-effectively produce hydrogel and small particle therapies on an extremely cost-effective basis. In addition to production capacity and expertise, ADMD is institutionalizing the procedures with Good Manufacturing Processes (GMP) as well as updating its Quality Assurance Plan, both strict mandates for FDA final approval.

Good news for investors is that with these processes and disciplines progressing, with some practices very close to being finalized, ADMD can take advantage of incremental milestones and plan a strategy to quickly advance the pipeline treatment focus to include treatment of lymph nodes, liver, and pancreatic cancers. Further, ADMD has been candid about the FDA approval process and has let investors know that the required work is well underway. What is also encouraging from an investors point of view is that shareholder value may get built in incremental stages, with each step of the development process rewarded with increased valuations that align with the anticipation of device and therapy approval.

Expediting the process, ADMD hired specialized legal and medical professionals, and the company plans to use its veterinary testing practices to optimize therapy technique. From there, the process moves to international human trials, with the hope that the ongoing animal experiments will provide regularly updated and useful data to apply toward the human studies. When all goes well, ADMD expects to file for FDA pre-market approval, with pre-submission meetings anticipated to begin at the end of August 2017. The meetings have the goal of assisting in a collaborative effort to design a study, provide data from completed animal studies, and to finalize the pathway for its Investigational Device Exemption (IDE) for human trials. Combining the sum of the process, ADMD will then file for its pre-market submission for authorization of FDA approval, a combined process that may take up to four years. However, keep in mind that the time required may be substantially shorter depending on how the FDA accepts current and previously documented data.

Changing the Capital Structure

ADMD is currently trading at roughly ten cents per share, and with approximately 50.1 million shares outstanding places the company market cap at around $5 million. The company has 3% insider ownership and a trading float of about 48.7 million shares. Understanding that the company has guided toward executing upon a reverse split to effectuate an up-listing to either the NASDAQ or NYSE markets, these share figures will change. Importantly, the authorized shares will also proportionately decrease from the current two billion authorized shares to a projected 40-60 million shares authorized. Although no specific reverse split plan has materialized, assuming that the company split at a 1:25 ratio, outstanding shares would drop to approximately 2 million shares with a trading float of just over 1.9 million shares. Although retail traders don’t welcome reverse splits, the reality is that the market cap’s remain unchanged and as long as the company executes on its strategic mission the valuation will increase from the time of the split, causing no material change in value for investors.

And, although the share structure may be recapitalized to a certain degree, relying on the premise that what lay at the core of any company is a genuine driver of value, ADMD may be a sensible investment.

Where Can ADMD Take Investors

With the pieces of this emerging company now getting assembled, a clear picture as to the likelihood of near-term success unveils itself. Investors should expect revenues from the IsoPet® product line beginning in early 2018 based on recent company accomplishments and speed of study. In addition to the revenue, investors are anxious to see if the company can execute on its strategy to establish international licensing agreements that are also intended to deliver income in the early part of 2018.

Getting to the revenue stream takes expertise, and ADMD has a strong leadership team already in place, coupled with a distinguished medical advisory board to guide company initiatives and trials. Additionally, ADMD is proving itself as an accomplished player and is currently working with major veterinary colleges across the United States, maximizing its recently completed steps to optimize proprietary production processes. Now, set to emerge with a platform that offers attractive drug economics, associated with lower operating costs and an expedited pathway to device approval, ADMD may be positioned to provide near-term shareholder value to its investors.

At this point, with the shares beaten down in expectation of a pending reverse split, better minds may prevail, taking an opportunity to invest in ADMD at levels which favor emotion over content. In the longer-term, the recapitalization not only helps provide a listing on a major exchange but also provides a consistent market which values companies on merit rather than market maker sentiment. And, with quality science in hand, and a nationally recognized management and advisory team in place, ADMD deserves to be in a better neighborhood than its current OTC listing provides. Thus, investors would be wise to take the pending reverse split at face value and understand that current share prices may not accurately reflect the potential and future at ADMD.

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. Red Chip paid CNA Finance $2,500 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Advanced Medical Isotope Corporation by CNA Finance. All information researched and provided through any article associated with Advanced Medical Isotope Corporation 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 AYTU Stock News

Aytu BioScience investors are counting on Natesto to lead the way toward profitability. And, while Natesto may indeed deliver AYTU to positive cash-flow status, or even net-profit levels within the next year, not recognizing the next strongest product in the lineup, MiOXSYS, would be like avoiding the obvious…not realizing that MiOXSYS is well deserving of a “best supporting product” nomination.

A large number of investors are aware of MiOXSYS, but because Natesto has recently been gaining the lion’s share of the attention and is building prescription momentum, bringing the MiOXSYS name to the forefront is well worth the effort, with the intent to demonstrate why the proprietary male infertility diagnostic system may help to revolutionize the way male infertility tests are performed around the world.

To understand how MiOXSYS works, and more importantly for investors, how it can benefit the revenue stream at AYTU, a quick review of the merits of MiOXSYS is warranted.

Where MiOXSYS Fits

Does the MiOXSYS system fit into the growing market for male infertility treatment? It sure does. In fact, in the United States alone there are over 4.5 million infertile men. But, on a global scale, that number jumps significantly, with an estimated 50 million or more males diagnosed as infertile. And, once the diagnosis gets made, the testing and treatment program becomes an exhaustive nightmare for patients trying to get a simple diagnosis and treatment plan that is focused and reliable. But, don’t look far, MiOXSYS provides a solution, and when compared to the current procedures in place to diagnose and treat male infertility, MiOXSYS has best-in-class potential. Here is why:

Of course, there is a starting point to the entire process, which is when a man is first diagnosed as being infertile, which in clinical speak gets defined as the male attempting to get his partner pregnant via sexual intercourse for at least twelve months with an unsuccessful outcome. Once diagnosed, if the man is eager to address the issue, he visits either a urologist or an IVF clinic to get an assessment as to his fertility status. In most cases, the treating specialist will order a testing algorithm that will set in motion tests that analyze semen quality as well as sperm’s general availability. The tests performed have been around for quite some time and stay focused mostly on sperm concentration, sperm motility (are they swimming?), and sperm morph, that is, are the sperm’s heads, necks, and tails formed correctly to enable useful function.

Some things never change, and it’s well known that the same tests have been in place for generations using a simple microscope and a lab technician in a urologist’s in-office laboratory. For a problem that can be so emotionally compelling for change, too little attention has been placed on correcting the issues, with the focus mainly being set in the diagnostic aspect of the infertility problem – and mostly on the female side. Other than maybe using computer generated assistance and AI analysis of semen quality, for the most part, the good ‘ole visual analysis is still the most popular means of diagnosis, which is time-consuming, somewhat crude, and less reliable to provide accurate data due to variability in the platform and variability from microscope operator to microscope operator. In fact, estimates point to up to 40% of men having “normal” semen parameters, but unfortunately, get sent to additional testing facilities despite the positive test results. The ‘standard of care’ is simple substandard in terms of truly assessing male infertility.

Where To Next For MiOXSYS?

Now, assuming that a man gets sent for the next battery of testing, they may find themselves in prestigious andrology laboratories at places like the Cleveland Clinic, Tulane University, or even the Mayo Clinic to get a further assessment of what may have been observed as a “normal” sperm analysis from the start. While the additional testing may prove to offer some psychological relief, the chain of events that led the patient there often breaks the urologist patient relationship, leads to significant patient frustration, and may potentially add significantly more questions and issues related to the original diagnosis – all while adding more costs and more potential confusion.

But, patients just don’t get sent onward so that high-priced urologists can earn some extra money. The point in the additional testing is that the patient hopefully gets a full analysis that includes “oxidative stress testing,” which, by the way, is precisely what MiOXSYS does. In addition to providing the similar benefits, and perhaps even greater analysis, is that patients will not need to travel hundreds or even thousands of miles away for the service, nor will they be forced to pay significant medical fees at a large academic medical center laboratory (where most of the advanced testing takes place). These benefits alone are substantial and point to the reason why AYTU investors should get focused on the promise of MiOXSYS, and consider it a potentially lucrative partner to Natesto. But that’s the “why”; what about the “how?”

Oxidative Testing Says What?

Currently, oxidative testing analyzes the oxidative stress of semen, which is the result of too many free radicals building up in the patient’s system that eventually overwhelm the body’s natural antioxidant defense system. And, as we know from the millions of dollars spent on ad campaigns, antioxidants are good, and the higher the level, the better it is for patients. In contrast, the lower the amount of free radicals in the system, the better it is for the patient, and may consequently lead to more fertile sperm levels.

But, while the oxidative testing may offer a more stringent analysis, the patients are often subjected to the same battery of tests already performed. As most people know, doctors like to work from their own arsenal of test results, so when patients get referred for further analysis to a large treatment center, they can expect to get duplicitous tests at additional cost.

Now, while oxidative stress testing may offer insight, it is costly, cumbersome, time-consuming, and requires a PhD or Masters level technologist to perform the test. The tests typically take three hours to complete and must be conducted at high-level academic laboratories. The problems don’t end there. The equipment is expensive, sometimes costing more than $40,000, have to be calibrated and amalgamated to measure semen, and are not FDA approved to provide precise measurements of semen analysis. In other words, the test is offered as an off-label capability of the device but must be tweaked to generate the intended results – and this disables the every day urology practice to run this battery of advanced testing.

However, things may soon change, and this is where MiOXSYS can take center stage.

The MiOXSYS Advantage

Leaving behind the need for expensive, clunky and sometimes unreliable results from an oxidative stress device that may not have been properly calibrated or amalgamated, MiOXSYS can perform complete oxidative stress testing in less than four minutes what has historically taken several hours to complete. In addition to the tremendous time saving, the MiOXSYS test requires no specialized training to be administered, can go from box to patient in a matter of minutes, and delivers comprehensive results in roughly four minutes. Along with a complete semen analysis, MiOXSYS comprehensively measures oxidative stress, and when compared to current standard of measurement is a superior provider of reliable information. And when a clinician knows the level of oxidative stress potentially causing the man’s infertility, he or she can direct treatments to lower oxidative stress and increase the chances of a pregnancy. Knowing oxidative stress can also help determine, in a relative sense, whether the guy’s semen quality is good enough to perform particular fertilization procedures.

While labs tend to focus on and measure oxidative stress as part of their battery of tests, in essence, they measure individual antioxidants or single free radicals. Thus, the tests are incomplete, less comprehensive and far less reliable in assessing semen’s oxidative environment. MiOXSYS, on the other hand, measures a global parameter called oxidation-reduction potential (ORP), which is a recognized composite measurement of all of the antioxidants and all of the oxidants together which gets assimilated in a single number. Remember, the expensive tests measure a single antioxidant, and MiOXSYS measures them all.

So, looking ahead, why in the world would a urologist need to purchase an expensive machine that provides sketchy results in order to do in-office oxidative stress testing? In short, they shouldn’t.

If they elect to use MiOXSYS, they are utilizing a single use, disposable sensor for each patient tested. Thus, the test is inexpensive, allows a technician to perform the test, and does not require three to four hours to complete. It takes minutes, and there is no significant capital outlay from the physician. For AYTU, the MiOXSYS system can be quickly accretive and lead to a consistent revenue stream by utilizing the “razor-razorblade” sales model. That is, the urologists continue to buy the particular test sensors designed specifically for use in the MiOXSYS system. Not only is MiOXSYS a winner on the cost-effectiveness front, but it also keeps the doctor/patient relationship ongoing and at the same time relieves the patient and the healthcare system of excessive expense and unnecessary cost.

Marketing MiOXSYS

MiOXSYS received its CE Marking in early 2016 and is available for sale in the EU and other regulated markets. After the CE Marking, Health Canada approved MiOXSYS for sale, as well. Since its broad approval, MiOXSYS has been sold into twenty countries outside of the United States, including Canada, Singapore, Japan, and Korea to name just a few.

Admittedly, AYTU has not directed investors to MiOXSYS just yet, as the ramp-up for Natesto has been a prime focus in late 2016 and 2017. However, even with AYTU staging just one to two full-time employees to work on the sales side of MiOXSYS, the results demonstrate promise. Increasing sales attracts attention, and for the MiOXSYS system, sales doubled from the first half to the second half of the year. For those keeping score, it’s clear that the momentum is beginning to take shape for MiOXSYS, following in the footsteps of Natesto. AYTU sold 60 systems last year and is on pace to double sales again during 2017, with expectations to place more than 100 systems around the world. Keep in mind, the system and its components are designed to generate continuous sales, following a similar course as the razor-razorblade sales model for replacement products.

Back of the napkin projections show that if AYTU can place 200 systems around the world by the middle of 2018, at product maturity, the system may be able to generate approximately $20,000 in annual revenue through the sale of the disposable components. Extrapolating that $20,000 projection to 200 systems, AYTU’s MiOXSYS may be able to generate $4 million in sales on an annual basis. And, that $4 million represents a huge step forward toward increasing shareholder value, as that revenue stream alone would almost eclipse the entire company’s valuation at today’s prices.

Another factor that should cause investor excitement is that the sales projections are ex-United States distribution, thus if the FDA provides clearance to sell MiOXSYS, the opportunity is substantially increased in term of potential systems sold and revenue generated. And, for those that like additional reassurance that the MiOXSYS is the real deal, six papers have been published in prominent peer-reviewed publications and journals, showing that ORP, the measure uniquely reported by MiOXSYS, provides a detailed, reliable and accurate representation of infertility analysis.

Will MiOXSYS Penetrate The Market?

Whether MiOXSYS gets taken at face value by an investor or whether a patient benefits from the inherent value in the reliable data provided by the MiOXSYS system, the fact of the matter is that MiOXSYS can do something that no other infertility analysis product can achieve. MiOXSYS quickly and inexpensively measures a key underlying cause of male infertility in a simple to use system that eliminates the need for a specialized professional to administer the procedure.

MiOXSYS, in simplest terms, is on the verge of bringing infertility testing to the masses and making what was once a test relegated to only the largest, best-resourced hospital labs in the world accessible to the thousands of urologists who treat male infertility on a daily basis. Once MiOXSYS gains momentum, sales should be a recurring stream, and for those that are looking for an additional reason to buy AYTU stock, the reason may be glaringly obvious…MiOXSYS may provide AYTU with another attractive shot on goal. aattractive shot on goal. attracti highly fertile future.

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 paid CNA Finance $4,000 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.

NuLife Sciences NULF Stock News

Technology is the bastion of change. And, at the pace of better science, not only potential but actual changes to lifesaving services and procedures will soon become a reality. For patients in need of organ transplantation, for instance, an emerging company is working to bring to reality the opportunity to reduce many years of waiting time and decrease the exposure to a degraded quality of life standard, as needy patients wait impatiently for either a tissue or organ match compatible for transplantation.

NuLife Sciences believes that they are in a position to reign in the future and is on the cusp of inventing transformational change. While just a micro-cap stock, NULF may become one of the few biomedical companies to advance recellularized human organ transplant technology, and promote medical research that may eliminate the need to locate pre-determined and compatible organ or tissue donors. NULF even goes a step further by potentially eliminating the need for anti-rejection drugs. To those in the industry, they know that if NuLife can accomplish this leap in science that it can transform an industry, allowing organ recipients to eliminate long waiting periods for a matched organ, and can even reduce or eliminate the need for dialysis for patients that are waiting for an acceptable match. Beyond those two extraordinary measures, NuLife Sciences believes that they can also offer the technology to eliminate the need for anti-rejection drugs and to save patients substantial amounts of money just through the reduced cost of medication and the potential elimination of expensive therapies that only treat a disease, but has no curative value.

Put together, what NULF is dedicating its mission toward accomplishing can act as the next transformational step in organ transplantation, and if successful can help the over 123,000 candidates that are currently waiting for a compatible and life-saving organ in the United States alone.

NULF Deserves Better

Despite the fact that the share price is sitting at less than a dollar a share and the trading volume is a bit anemic, the progress made on the clinical front makes NULF a strong candidate for those investors looking for long-term, aggressive, high-risk/high-reward stock to add to their portfolio. As is the case for many emerging biotechs, NULF became part of a technical acquisition by an active, in good standing, publicly traded company. The strategy allowed NULF to immediately take advantages of the benefits of being a public company without the exorbitant costs and time associated with an initial listing application.

From a strategic standpoint, NULF is targeting the treatment of not only the approximate 31,000 organ transplant cases per year but also looking to mark and treat the remaining 120,000 plus patients that are waiting in line. And, the market is not shrinking. Instead, the market is growing, plagued by logistical problems which lead to the death of about 22 people each day, who die in wait for a compatible organ. Imagine, if NULF can generate the science and practices necessary to allow for expedited organ transplantation and eliminate the need for excessive screening, hundreds of lives will get saved each year. But, beyond those hundreds saved, thousands more can be served, not only making organ transplantation compatible to their body but can help to save the medical industry millions of dollars a year in drug cost savings, a portion of which Medicare only covers for three years.

Beyond the dollars saved though, which is a crude comparison when discussing human life, NULF brings much more to the table, benefits that may have a far-reaching effect on an entire industry. Thus, the story becomes ironic in that a small but emerging, sub-dollar stock may hold the key to altering the path of organ science and transplantation procedure. And, despite that the company is still a relatively unknown disruptor of science in a broad landscape of multi-billion dollar companies, NULF may be the one to cause a systemic shift in the industry.

How Will NuLife Pull It Off?

Initially, NULF is looking to target the kidney transplantation market, which since 2015 has averaged roughly 18,500 cases per year. Of all transplants performed, kidney procedures account for the bulk of the action, representing approximately 58% of all cases, followed by liver, heart, lung, and pancreas transplants. Unfortunately, most patients die while waiting for an organ, despite tens of thousands of dollars spent on dialysis, drugs, and treatment. Further complicating the landscape is that all current transplant patients require anti-rejection drugs, the most severe of medications that have been known to cause grave and adverse reactions in patients. But, at this point, or until NULF can produce otherwise, patients will remain mired in the specific drugs despite the debilitating effects. In some cases, notwithstanding the wait for an organ, the anti-rejection drugs prove incapable of doing their job, adding insult to an already dismal situation.

Although NULF only became its own publicly trading company about eight months ago, the science developed through 15 years of committed research, with resulting breakthroughs in both hematopoietic research and transplant techniques. Its goal of the study was to first address the issues of organ compatibility and the need for anti-rejection drugs in both the patient and the donor. During the studies, NULF conducted pilot studies, with its first animal surgery three years ago and an additional three animal patient surgeries in total since 2014.

The technique makes the difference and what NULF is trying to prove is the key to the progress. Like all transplants, the process begins with a healthy donor. From there, the organ goes through a decellularization process to isolate the extracellular matrix of tissue from its inhibiting cells, which is expected to provide an ECM scaffold of the original body tissue. Next, NULF initiates the cell culture process, where specific cells get harvested from the bone marrow of the intended recipient. But, the next step is where the process changes, and if NULF can substantiate its novel and patented technique to the recellularizing process, the method may become a mainstream practice for all transplant cases going forward.

The patented NULF recellularizing process takes particular hematopoietic cells that are used in the process and adds proprietary temperature and pressure factors. Through the associated vacuum process, specific cells get released from platelets without complete platelet degranulation. Coupled with those first two steps, the negative pressure created by the vacuum pulls the growth factors out of the platelets and puts it directly into the plasma. Then, once processed, the cells get reintroduced into the recipient with the intent of influencing the further growth of an already implanted and recellularized organ. Results from the animal studies have been extremely encouraging, and the swine kidneys used in the trial should provide reliable data, as they most closely resemble the kidney to that of humans. Thus, in the recently announced initiation of their pre-clinical study, NULF hopes to demonstrate that after the novel decellularization program, the creation of a kidney scaffold was produced upon which a new organ, unique to the recipient may get successfully rebuilt.

Organ Generation Is No Longer Science Fiction

Ten years ago, the thought of generating or growing an organ suitable for human use was taken seriously by a small handful of scientists. Now, just a decade later, scientists believe that they will soon have the capability to produce certain human organs with the use of 3D printers. While NULF is not prepared to use the 3D method just yet, they are in a way generating results that should demand significant industry attention.

What NULF is demonstrating is that in its animal (swine) studies, it can take a created kidney scaffold and populate it by injection from immature bone marrow cells from the recipient, and then allow the stem cells to differentiate into mature kidney cells. From that point, the growth of the kidney is genetically identical to that of the recipient, which is then provided processed blood to aid the recellularization process before and after the organ is implanted. Now, assuming that NULF continues to generate positive results, not only do potential partnership opportunities arise to expedite the company’s program, but the direct impact that a successful trial can bring to the transplant industry can be enormous.

First things first, let’s highlight the most beneficial aspect of a successful NULF procedure: it can change to days, from years, the time required for a patient to be identified and readied for transplant. This time decrease is in stark difference to the up to 15 years of waiting time seen in many transplant cases. NULF can help eliminate a substantial portion of the “attempt to match” diagnostic testings required before a procedure is performed, and can alter the entire logistical landscape of the industry by being able to work on local opportunities instead of care flight delivered organs, many of which prove to be non-compatible with the recipient. Beyond the logistical and life-saving measure, the direct cost-benefit and savings can be substantial, eliminating the over $17,000 per year required for anti-rejection medication and the upwards of $85,000 per year for dialysis treatment while a patient is waiting for a new kidney.

Yes, money and savings are significant, but it pales to the quality of life benefit that the NULF procedure can afford to patients, increasing mortality rates and at the same time allowing patients to stop taking the debilitating anti-rejection drugs required to remain healthy.

Is NULF close to approval? Well, investors should not assume that the company will be commercializing the procedure within the next year. However, NULF has identified a pathway to commercialization which offers an insight as to the progress made by the company. As stated earlier, the progress made is a culmination of over 15 years of dedicated science and research, which was initially used as a process to heal wounds. From the technology end, the discovery process was born, and patent applications were filed and granted in 2015 which provides critical protection over proprietary processes and intellectual property, enabling the company to enter into potential partnership agreements more securely.

From NULF discovery came the first preclinical experiments. During a three-month period, with one procedure per month on three different animals, the company produced approximately 12 different tests, each with a specialized focus on specific research and planned study outcomes. The current animal studies are being performed in collaborations with both Florida International University and Nova Southeastern University, with the aim of encouraging opinion that additional animal studies should be conducted to determine the direction of the program. The pre-clinical animal studies are expected to continue throughout 2017, with results announced soon after completion, also planned for late 2017. Once complete, NULF plans to complete appropriate documentation protocol, expand its advisory board, and to meet with the FDA to propose a clinical pathway to commercialization, also expected to process in the second half of 2017.

It’s Not All About Transplants, Though

Although the primary target of NULF technology is to expedite organ transplantation, the technology has other far-reaching applications. With two patents granted that protect significant aspects of organ transplant procedure, the company has a 17-year window of protection that begins at the conclusion of its clinical investigator’s program. In addition to the patent protection, NULF expects to file with the FDA an application to become fully licensed for the comprehensive use of cytokines and be granted a 14-year window of exclusivity for process and therapy.

Getting the help from both the patent board and the FDA will contribute to expediting clinical programs as well as to protect intellectual property. From where NULF currently sits, they can advance research for transplantation factors of other vital organs.

In addition to the role in transplant, NULF believes that they are well-placed to expand the technology into additional fields that can work to assist in the building of the immune system. Further research demonstrated the potential to improve chronic wound closures, offer preventive care and to bring to the market novel and innovative methods for treating an array of patient conditions having to do with cellular or wound technology.

Managed by a respectable team of medical professionals and advisers, NULF had slightly over 31 million shares outstanding as of May 2017. Like most emerging and potentially transformative companies, NULF will likely need to raise additional funds to shore up the cost of future studies. While other collaborations or partnerships may reduce the company’s operating cost, NULF is getting to the point whereby raising cash on their own and not giving away excessive equity may indeed be a better long-term road to follow. For those with a long-term horizon and are more than willing to let this emerging company continue to prove its science, getting into the stock at these prices may be an exceptional long-term proposition. At less than a dollar per share, if the company does raise money, it will be dilutive, so taking a cost average approach into NULF may be advisable.

One thing is for certain, if NULF is successful in developing this revolutionary approach to transplantation, patients and investors will benefit. That, in and of itself, is an investable thesis and the value proposition in the technology already is worthy of a share price in excess of current market value.

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 NuLife Sciences by CNA Finance. All information researched and provided through any article associated with NuLife Sciences 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 AYTU Stock News

Now that Aytu BioScience’s Natesto®, a nasally administered testosterone replacement therapy, is beginning to tap into the market share of sector leaders like Androgel® and Axiron®, the question remains as to how long will it take for the proven and perhaps best-in-class treatment to gain sales traction.

The story behind the growth curve is not typically well known to the retail investor, as the time required for a sales force to break into a market does cause some start-up related delays. However, with much of the sales force’s training, territory routing, and physician access credentialing obstacles now cleared, Natesto® is beginning to bear the fruits of a sales team that is now fully operational. Additionally, while it may be hard to believe, some of the best-known alternatives to current treatments and therapies still get overlooked by medical professionals that have come to know that the simplest route to prescribing medication is to offer the one that is the most convenient or most covered by insurers. Unfortunately, such a practice can lead to a sad state of affairs for patients, and the convenience enjoyed by a prescribing physician, especially in the TRT market comes with potentially significant side effects and a host of unintended consequences.

A Refocused AYTU

Now that AYTU has its sales force totally dedicated to Natesto®, the recent ramp up in prescription volume may be a telling indicator of the future trend. Recent prescribing data shows that Natesto® is not only gaining favor with physicians but now that Aytu’s sales-force has cleared much of the many hospital system’s six-month credentialing process, doors to doctors’ offices are beginning to open. It’s not only the credential process that slowed the pace of Natesto® growth, by the way. Other factors include the fact that doctors don’t want to mess with the time required to facilitate payer reimbursement processes for their patients. In other words, until Natesto® gets reimbursement allowances from several major insurance carriers, the ramp up period may be slow. Good news for investors, though, major insurers are beginning to understand that the benefits provided by Natesto® far outweigh the known complications and risk from current market leaders, inclusive of Androgel® and Axiron®. And once Natesto® gets its share of payer agreements in place, Natesto® may very likely grab a significant portion of the current $2 billion market.

Even without the lion’s share of the potential market, if Natesto® can simply earn a 5% piece of that market, AYTU may be put on the track to deliver tremendous earnings potential. Assuming Aytu can climb up toward the mid single-digit market share for Natesto®, investors may be looking at a $100 million revenue stream for Natesto® alone. And, the product deserves the share, and here’s why.

Is Natesto® The Best-In-Class TRT?

Natesto® is notable because it has differentiated itself from any other testosterone replacement therapy currently on the market, being the only nasally administered treatment available to patients. The nasal application of Natesto® has significant advantages in comparison to the topical application employed by other TRT products. Every topical TRT product, such as AndroGel®, Axiron®, and Fortesta®, carries a Black Box warning on the label, informing users of the dangers of an accidental transmission of the product to women or children. Users of these medications must physically “quarantine” themselves during the application process, or else they risk accidentally dosing their wives or children with the treatment through physical contact. Natesto®, on the other hand, is free of these issues due to its unique application method, making it the only TRT product on the market that doesn’t carry the Black Box warning. This alone is a huge selling point for the treatment and has grabbed the attention of physicians and patients alike.

Not only does Natesto®’s nasal administration eliminate the risk of accidental transference, but it has also been clinically proven to be both safer and more effective than its topically-applied competitors. Take AndroGel for example. Androgel is a TRT product that works by releasing a relatively constant amount of testosterone into the user throughout the day. However, because of this new influx of testosterone flowing through the user’s body, the brain begins to believe that the body’s testosterone levels are sufficient and slows the natural production of the necessary hormones LH and FSH. And, lowering those two hormones is not a good thing.

Reduced levels of LH and FSH can have extremely undesirable effects on the user’s body, including a dramatically lowered sperm count and even testicular shrinkage. Additionally, a deficit of LH and FSH hormones can cause the brain to slow natural testosterone production as well, potentially making the patient dependent on artificial treatments to maintain proper T levels. None of these symptoms have been experienced within Natesto®’s clinical trials. In fact, in a press release from January 18th, Aytu released details of a trial in which LH and FSH remained at normal levels after 90 days of treatment with Natesto®. Since Natesto® doesn’t affect LH and FSH levels, it wouldn’t be expected to cause the adverse side effects associated with other treatments, giving Natesto® a distinct safety advantage over its competition.

Another issue faced by the TRT market is that all long-acting gel preparations and injections are likely to cause increased hematocrit levels in the patient. This increase causes thicker blood within the user’s body, which significantly enhances the risk of stroke. To compensate for their higher risk of stroke, patients often need to lower their dosage or even quit their TRT medication; some also turn to the undesirable route of donating blood more often to thin it out, which is not exactly an easy solution to the problem at hand. Again, Natesto® has been clinically shown to outperform other products in this area – in fact, Natesto® 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.

Natesto® Prescriptions Spike Higher

So, by now it should be obvious that Natesto® has serious advantages over its competitors – but investors may ask, why isn’t this already the top choice of treatment among physicians? Here’s the answer – it’s well on its way. Natesto® has seen a sharp increase in prescription counts throughout 2017, presumably due to the known and significant benefits over other TRT options. Amassing just 270 total prescriptions in March, that number has since risen to 593 new prescriptions in June, more than a 100% increase in prescription count. This figure continues to rise higher as more and more physicians become aware of the many advantages offered by Natesto®. Natesto®’s unique application method and safety benefits are more than enough to make it deserving of doctor and patient attention, and when it’s rising share in the market is brought into the equation, investors owe it to themselves to keep an eye on AYTU and their Natesto® product.

With Natesto® now bringing well-deserved revenue into the company, in addition to revenue expected from the pipeline products, AYTU is extremely well positioned moving forward. Then, factoring in the recent $11.5 million private placement, and it’s not too difficult to understand why investors have decided to fund the company with high hopes for continued trends higher in prescription volume. While it has taken AYTU a some time to turn the corner toward profitability, now that the traction appears to be sustainable it would make little sense to bet against the potential that Aytu BioScience has to offer.

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 paid CNA Finance $4,000 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 Next Group Holdings 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...