Biotech

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Aytu Bioscience AYTU Stock News

Aytu Bioscience (AYTU) stock closed 17% higher on Thursday, giving back a portion of its daily high that traded more than 31% higher. Volume was strong for the stock, with shares trading hands at over 3X average trading volume.

CNA Finance’s Chief Research Analyst, Kenny Soulstring, provided research coverage for AYTU on Wednesday and expected to see AYTU capitalize from several on-market product opportunities that include revenue from Natesto, ProstaScint, Fiera, and MiOXSYS.





Soulstring sees’s significant value enhancing opportunity from Natesto in the near term, as Natesto is the only testosterone replacement therapy on the market that is not required to have an FDA mandated Black Box Warning. Natesto has been proven safe and effective in its clinical trials and is the only FDA-approved, nasally administered therapy on the market. Sales of the product have gained strong momentum during the previous six months with sales up by over 20% between April and May and compounded an additional 20% in May and June of 2017. Natesto is addressing a multi-billion dollar market opportunity and AYTU is building its sales-force to exploit the potential of the therapy.

Beyond Natesto, Soulstring believes that each of the other three on-market treatments delivers equally impressive opportunity. ProstaScint, its prostate cancer screening agent, is focused on the over $2.5 billion prostate cancer market. Fiera, its female pre-intimacy device to address female sexual dysfunction, is targeting the under-served 53 million women in the U.S. market alone. And, MiOXSYS, AYTU’s male infertility treatment, is looking to capitalize on the expected $4.7 billion dollar market opportunity projected by 2025.




AYTU Has Multiple Shots On Goal

Not only does Soulstring believe that AYTU is in a strong position to capitalize from each of its products and therapies, he notes that because each of the products is already commercially available on a global scale that much of the regulatory risk is already behind the company.

While MiOXSYS is progressing through the 510K approval pathway for marketing in the United States, each of the other drugs has already received either FDA-approval or a CE marking designation.

Combined, AYTU is targeting a potential market of more than $10 billion with products that have been clinically proven to be safe, effective, and even best-in-class when compared to other marketed treatments and FDA-approved therapies.

Soulstring stated, “While AYTU’s share price may be depressed because of recently announced plans to reverse split the stock, the inherent value of the pipeline is well beyond the current market cap of the company. In fact, any of the product candidates already on-market is deserving of a multiple far higher than the current AYTU share price, based on addressable market and regulatory clearance.”

Soulstring believes that investors have a short window of opportunity at these price levels and that the next conference call has the potential to deliver news that can propel the share price significantly higher than current levels.

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Delcath Systems, Inc. DCTH Stock News

Delcath Systems, Inc. (NASDAQ: DCTH) has had an interesting time in the market as of late. After climbing dramatically, the stock seems to have gotten stuck in a rut over the past couple of weeks. So, what’s the deal? Today, we’ll talk about the good, the bad, the ugly, and the opportunity surrounding DCTH.





The Good With Regard To DCTH

There’s no doubt that Delcath Systems does have some good going for it at the moment. First and foremost, ChemoSat has been approved in Europe. As a result, a treatment that the company created is actually saving lives as we speak. However, that’s not the only bit of good news surrounding the company either.




On top of movement in Europe, DCTH is currently working on multiple clinical trials here in the United States. If these trials go well, as I would imagine that they would considering the European approval, the company will soon be bringing its life-saving cancer treatment to patients in the United States. Of course, if this were to happen, the opportunity to drive revenue, profits, and stock price growth will be tremendous.

The Bad With Regard To Delcath

While there is quite a bit of good when it comes to DCTH, as with just about any other company in the world, this one has made some mistakes. Unfortunately, these mistakes have put the company in a financial position that it needs to find a way to dig its way out of. While the management at the company enjoys exorbitant salaries, the company is struggling to stay afloat financially.

However, this is just one of the many financial mistakes that DCTH has made. The truth is that I’m not knocking them. I own a business of my own, and I’ve made financial mistakes of my own. However, there is a harsh reality that must be faced here, and that brings us to…

The Ugly With Regard To DCTH

Unfortunately, because of the financial mistakes that Delcath Systems has made throughout their years in business, they are stuck between a rock and a hard place. With the amount of authorized shares at the brink, opportunities to tap into funds are becoming more and more difficult to find. Raising funds through the market isn’t working well either. Unfortunately, the stock price is far too low to attract the investors that could make a change here.

So, what we’re left with is a strong possibility of a reverse split. Now, investors do need to approve the split, and many continue to say no. Concerned with high salaries and other financial drags, investors want to see DCTH management figure out how to get out of the pickle they are in.

However, the ugly reality is that, even if management at DCTH decides to reduce their salaries, they are still going to need a reverse split to stay afloat. This will create an opportunity to bring in newer, stronger investors, instead of the penny traders that have been swarming the stock for so long. Look, I love this company and what they are doing in the oncology space, so this is as hard for me as it is for you. But the ugly truth is that without shareholder approval for a split, we’re going to see some very hard times ahead.

The Opportunity

Ultimately, there is a ton of opportunity surrounding this stock. While a reverse split isn’t what most people want to see, it could save this company. At the end of the day, the RS isn’t death, it’s an opportunity to bring in money that will bring life into the company.

If there’s not going to be a reverse split, there’s also an opportunity in the idea of an acquisition. While this is a slim possibility at the moment, it is indeed a possibility. Think about it. DCTH is a stock with a relatively small market cap, considering that they already have an approved treatment on the market. Wouldn’t a bigger oncology company want to get their hands on the company’s assets? Of course they would! However, the question is whether or not a company would acquire DCTH given not just its assets, but its financial picture. Nonetheless, this is still a plausible opportunity.

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Final Thoughts

At the end of the day DCTH has created an incredible treatment, one that’s approved in Europe and likely to become approved in the United States. However, the company also has to survive long enough to see this come to fruition. For that, they need the backing of their shareholders. At the end of the day, I’d like to see Delcath bring the company to success, would you?

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Actinium Pharmaceuticals Inc ATNM Stock News

Actinium Pharmaceuticals has just seen its position in the race to find a treatment for newly diagnosed AML patients substantially improved. ATNM did get some help from Seattle Genetics (SGEN), who announced that they are suspending their phase III CASCADE study to treat AML, but current ATNM investors already know that ATNM is blazing its own path toward regulatory approval.

Many of those following the AML trials were aware of the potential flaws in the SGEN study, a trial that utilized cytotoxins as a treating agent, which may have contributed to patient death during its 2016 trial. Recently, SGEN took the halt to the endpoint, ceasing the study after consultation with the Data Monitoring Committee, who determined that the treatment may have been the cause of higher death rates and fatal infection.

The bad news for SGEN investors, as well as for patients, is that another once-promising treatment has proved to lack therapeutic value, leaving AML patients increasingly reliant on emerging innovation that could potentially treat and cure the disease. With the clinical field shrinking, only a handful of prospective drug developers appears to be a viable contender in creating the solution. However, there is one company that is separating themselves from the pack, based on a credible and innovative method of treatment.

Once again, investors need to say hello to Actinium Pharmaceuticals.

Actinium’s Benefits From Seattle Genetics Failure

Some biotech investors tend to root for stocks over patients, ignoring the crucial need for treatments that can cure deadly and debilitating diseases. I am not one of those. With the scars of cancer in my family tree, finding a cure is a top interest. The task of discovering the companies that may provide these therapeutic answers then involves digging deep into the technology to find trends in both efficacy and innovation. From an investment perspective, the rewards will follow success, therefore, finding the emerging gems of the industry provides an opportunity for both patient survival and financial reward.

Actinium investors have long compared the differences in the company’s Actimab-A trials to the trials conducted by SGEN and Pfizer. In no uncertain terms, ATNM investors have come to believe that the path taken by the competitors mentioned above is plagued with clinical concerns. Unfortunately, it took several additional patient deaths before SGEN stopped the trial, and now Pfizer is filing a new application to bring Mylotarg back to the market. Those who follow the progress made in the AML sector know that Mylotarg was already stripped from the market in 2010 due to its debilitating and harmful effects on patients. Perhaps Pfizer believes that the FDA may become more amenable to giving the drug a second chance based on the somewhat small development landscape. Let’s hope not.

The FDA has better tools at their disposal that make far greater sense than subjecting patients to more of the same from Mylotarg. In fact, the FDA does not have to look far, with ATNM’s phase II trial producing consistent and impressive results that position the company closer to an actual product approval.

Can ATNM jump through a few hurdles and be granted either Fast Track Designation or Breakthrough status for Actimab-A? With a successful phase II trial, I think they can. And, that’s precisely the path that investors are looking for ATNM to take.

The Actimab-A Difference

Some investors are just now learning about ATNM and its active pipeline of promising treatments. But, with the most recent setbacks by SGEN and PFE, it’s time for investors to pay close attention to the details. ATNM has several irons in the fire, with Actimab-A its contender to treat patients with AML. Not only is it a contender, but Actimab-A may now be the sole viable candidate in the clinic, with the therapy being the only CD33 targeting radioisotope-based drug candidate currently in human clinical trials.

More specifically, the drug is intended to treat elderly patients newly diagnosed with AML. Actimab-A, developed at Memorial Sloan Kettering, is a second-generation therapy using ATNM’s HuM195- alpha program. To date, ATNM has treated more than ninety patients in four clinical trials targeting CD33; a molecule expressed on 90% of AML cells. Born through a prior study of Bismap-A, ATNM is demonstrating that the second generation therapy produces an apparent anti-leukemic effect, leading to increased survival rates among patients.

A stark departure from using toxic measures to treat the disease, ATNM is utilizing the radioisotope Actinium-225. Despite the potential for cytotoxicity from the isotope, the company has demonstrated in clinical data that the cytotoxins only travel a minimal distance during the therapy, and therefore, the risk of serious adverse events due to a toxicity profile is benign. Furthermore, because the drug has produced such limited adverse reactions, many of the critics that initially looked at the cytotoxins as a potential flaw in the treatment have been largely quieted.

Similar to the path taken by most drugs approved by the FDA, the evolution of design for Actimab-A has proliferated pieces of previous trials and combined the best and most promising elements from each to advance the current phase II trial. Now capitalizing on a clean safety profile and an apparent anti-leukemic effect, the commercially viable isotope 225 has become an essential element in the drug’s design. The key to it all, though, is that ATNM has found that targeting CD33 notably intensifies the therapeutic value. Actinium’s progress in effectively targeting CD33 has opened the eyes of many in the large pharma space, recognizing that ATNM’s Actimab-A trial is currently one of the most advanced programs addressing CD33, and brings with it the serious potential to become a best-in-class therapy in treating AML.

Now, with only Mylotarg coming back into FDA focus, the chances that Actimab-A gets afforded an expedited FDA review may become likely. ATNM knows Mylotarg well. In fact, the Chief Medical Officer at ATNM, Dr. Mark Berger, was a lead developer for Mylotarg during his tenure at Wyeth (now Pfizer). While I can’t speak for the good doctor, his decision to join ATNM is a strong testament to his belief that Actimab-A is on the verge of not only exposing the flaws in Mylotarg but at the same time bringing a drug to market that will have superior therapeutic value for patients. Although the drug demonstrated limited patient benefit, few in the industry will argue the facts that Mylotarg falls well short of being a viable therapy to treat the disease. At this point, limited benefit with proven severe side effects gains little favor, and when compared to Actimab-A, Mylotarg has fallen well short of patient value.

Targeting CD33 Is The Difference

Now with attention focused on the benefits of targeting CD33, ATNM is gaining momentum in the eyes of its peers. The lagging share price is not in line with clinical results, but those things end up taking care of themselves quickly once supporting data is confirmed. As experienced investors know, it’s not uncommon for stocks in the biotech sector to gain hundreds of percentage points in a single session based on compelling data. Now, with ATNM looking to conclude its phase II trial and report results in the second half of 2017, investors are closely monitoring the details.

With valuation being a concern, it’s fair to take a moment and look at the lack of consistency in providing fair market cap valuations. ATNM, at current share prices, holds a market cap of roughly $59 million. Compare this valuation to a company like Immunogen (IMGN), who is also targeting newly acquired AML by utilizing the same ADC-alpha emitters, and the difference in valuation becomes a head scratcher. It is fair to say that not only is the sentiment disproportionate, the difference becomes more blatant when investors acknowledge that ATNM is in a better position to advance through its phase II and III trials quicker than IMGN. But, investors can’t expect markets to be fair, nor do investors expect markets to understand clinical data. It’s up to the investment community to figure out these metrics, and that’s what creates opportunity.

Significant opportunity is what makes the ATNM story so compelling. To date, the phase II Actimab-A trial has treated 18 patients, with the age of patients being 60 or older. Utilizing data from the successful Phase I trial, which treated patients with relapsed or refractory conditions, the phase II trial is designed to address elderly patients with newly diagnosed AML. The trial design is also a fractionalized, dose escalating trial, a departure from the single dose phase I design.

Safety and tolerability results have been exceptional, and when compared to competitors, specifically Mylotarg, it emerges as a best-in-class opportunity for the drug. The refined approach in the phase II trial is designed to be more responsive than the phase I trial, and includes not only fractionalized dosing but has also led the medical team to hypothesize that the regimen produced corrections in peripheral blasts, in turn eliciting higher favorable response rates from patients. The fractionalized dosing during the phase II trial has likely contributed to these favorable results, and also encouraging is the fact that the efficacy rates generated appear to be independent of patient population or severity of the disease.

ATNM is working a classic study, and their accumulation of positive data may very well lead to drug approval. Preliminary data is impressive, but ATNM still has some work to do before investors can rejoice. Despite sitting in a position that deserves far more market attention, ATNM will need to complete its 53 patient trial data set and work closely with the FDA to facilitate their refined testing protocol, which now incorporates PB burden thresholds in the inclusion data.

By a wide margin, ATNM appears to have secured the enviable position of being the clear leader in treating AML. Their direction is unique, and the science has amassed substantial credibility from industry peers. For investors, Actimab-A offers great opportunity to be rewarded by significant increases in share value. For investors, the next eighteen months are primed to deliver numerous milestone achievements.

Actinium Catalysts

The bottom line for most investors comes down to the near-term catalysts that a company has to offer, and there’s nothing wrong with that philosophy. And, for ATNM investors, the near term is positioned to generate significant milestones. Other than the Actimab-A trial, ATNM is well on their way to further success from its phase III SIERRA trial with Iomab-B.

Iomab-B, a second promising pipeline candidate, received Orphan Drug designation from the EMA in 2016. Investors can expect interim updates and analysis on this trial in 2017, as well as enrollment and DMC reports provided to the market when appropriate. Top-line data from the planned 150 patient trial is expected during the first half of 2018. Investors can further expect to follow an ambitious clinical plan, with four simultaneous clinical trials in progress, each offering significant potential for partnership, licensing, and strategic opportunity.

Yes, these clinical trials cost money, and the company’s cash balance of roughly $18 million at the end of March 2017 is projected to last through the first half of 2018. ATNM listed approximately 58 million shares outstanding as of March 2017. Along with the stable capital position, investors should also keep in mind that partnership opportunity exists for each of the trials currently underway, and additional value drivers can come from any of the twelve potential milestones expected during the next 18 months.

Drugs don’t get approved quickly in the United States, and clinical trials are often lengthy and frustrating for investors. But, keep in mind that while these frustrations exist, ATNM is ahead of any competitive threat in treating both AML and multiple myeloma. Indeed, that’s a strong reason to consider an investment into ATNM, seizing an opportunity to generate significant value in the next few months. ATNM management is the first to acknowledge that the clinical programs have taken longer than expected, but they are also quick to point out that the company has not lost a shred of competitive advantage over potential competing therapies. The programs advanced by ATNM are fresh, progressive, and innovative.

Is the sum of the parts greater than the whole in the case of the ATNM valuation? Many believe it is, and they are smart to follow in that belief. At a buck and change a share, the valuation borders on ridiculous, and appears to be more punitive in nature than it is a real indication of the current and near-term position of ATNM as it relates to clinical progress on multiple fronts.

At a market cap of $59 million, even a single partnership or licensing collaboration could double or triple the market cap in an instant. For investors, picking an investment timeline is crucial, and while investors may believe that the ATNM opportunity will take months to materialize, they may want to reconsider and act quickly. With both SGEN and PFE all but out of the race for a viable treatment, the opportunity to buy ATNM at current levels may finally and accordingly get corrected.

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. Actinium Pharmacueticals paid CNA Finance $3,000 to hire Perceptive Analytics for research and writing services as well as other investor relations services provided to Actinium Pharmaceuticals by CNA Finance. All information researched and provided through any article associated with Actinium Pharmaceuticals and published on CNA Finance is public information that is documented and available upon request. CNA Finance encourages all investors to seek professional advice before making any investment decision.

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Tetraphase Pharmaceuticals Inc TTPH Stock News

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) is having an incredible time in the trading session today after providing an update with regard to a key clinical trial. Of course, the update was positive, leading to excitement among investors and sending the stock upward. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:17), TTPH is trading at $7.56 per share after a gain of $0.65 per share or 9.49% thus far today.





TTPH Announces Positive Top Line Results!

As mentioned above, Tetraphase Pharmaceuticals is having a strong day in the market today after announcing positive top line results from a key clinical trial. The trial, known as IGNITE4 was a phase 3 trial evaluating the efficacy and safety of twice-daily intravenous eravacycline. In the study, the treatment was compared to meropenem for the treatment of patients with complicated intra-abdominal infections. The 500 patient clinical study proved statistical non-inferiority of eravacycline to meropenum for the primary efficacy endpoint of clinical response at test-of-cure visit. In a statement, Joseph Solomkin, M.D., Professor Emeritus in the Department of Surgery at the University of Cincinnati College of Medicine and Advisor to TTPH, had the following to offer…




Complicated intra-abdominal infections are increasingly caused by resistent pathogens and appropriate antibiotic therapy is critical to successful outcomes… Collectively, the data from the IGNITE program in cIAI versus two widely-used comparators, ertapenem and meropenem, provides compelling evidence for IV eravacycline monotherapy and its potential to be a valuable new addition to the limited toolkit currently available to treat serious, and often life-threatening MDR infections.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on TTPH. In particular, we’re interested in following the ongoing work surrounding IV eravacycline monotherapy. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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EnteroMedics Inc ETRM Stock News

EnteroMedics Inc (NASDAQ: ETRM) is having an overwhelmingly strong start to the trading session today, and for good reason. In an SEC filing, the company disclosed a collaboration agreement. Of course, this led to excitement among investors, causing gains and prompting our friends at Trade Ideas to alert us to the movement. At the moment (9:31), ETRM is trading at $4.90 per share after a gain of $0.56 per share or 12.76% thus far today.





ETRM Enters Into Collaboration Agreement With Galvani Bioelectronics

As mentioned above, EnteroMedics is having a strong day in the market today after releasing an SEC filing that updated investors with regard to a new collaboration agreement. According to the filing, the company entered into an agreement with Galvani Bioelectronics Limited.




Under the terms of the agreement, ETRM will modify its vBloc system for use in pre-clinical research by Galvani. As a result, the company will receive payments for its development work and supply. It’s also important to note that ETRM will retain all rights, title, and ownership in the intellectual property of the new device. From there, the new device will be licensed to Galvani. Under the terms of the agreement, Galvani will have first negotiation rights for potential exclusive as well as non-exclusive supply by EnteroMedics of the developed device.

This is a clear indication of the opportunities that ETRM may have with regard to leveraging their IP portfolio, opening the door to third party sales and licensing opportunities.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on ETRM. In particular, we’re interested in following the progress of this collaboration agreement and excited to see the doors that this agreement opens. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Dynavax Technologies Corporation DVAX Stock News

Dynavax Technologies Corporation (NASDAQ: DVAX) is off to a rough day in the market today, and for good reason. The FDA has released briefing documents with regard to an upcoming VRBPAC meeting surrounding the potential approval of the company’s Hepatitis B Vaccine. Unfortunately, there is one primary concern that seems to be frightening investors. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (9:11), DVAX is trading at $8.90 per share after a loss of $1.00 per share (10.10%) thus far today.





FDA Releases DVAX Meeting Briefing Documents

As mentioned above, Dynavax Technologies is having a rough day in the market today after the FDA released briefing documents with regard to an upcoming meeting. The meeting, which will take place on July 28th (yes, 2 days away), is a Vaccines and Related Biological Products Committee meeting. This is an open-session meeting designed to discuss the safety and efficacy of HEPLISAV-B, a Hepatitis B Vaccine that DVAX has been working to bring to the market.




However, investors seem to be concerned with regard to some major concerns that the FDA seems to have with regard to the treatment. The main concern here is imbalances in deaths and SAEs of MI as well as imbalances in AESIs. To go through the briefing documents yourself, click here.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on DVAX. In particular, we’re interested in following the progress toward bringing HEPLISAV-B to the market. While we knew that this wasn’t going to be easy given prior denials of DVAX treatments, the meeting on Friday will tell us whether or not this is going to be plausible. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Aytu Bioscience AYTU Stock News

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

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

Natesto® Sales Surge

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

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

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

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

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

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

MiOXSYS® Now In 20 Countries

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

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

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

ProstaScint® Is Already FDA-Approved

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

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

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

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

Fiera® Added To Aytu’s Product Arsenal

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

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

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

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

How Aytu Bioscience Brings It All Together

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

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

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

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

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

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

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VBI Vaccines, Inc. VBIV Stock News

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





The hepatitis B market

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

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




A look at the clinical program – overview

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

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

The clinical program – the first phase III study

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

There are two primary endpoints in place.

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

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

The clinical program – the second phase III study

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

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

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

Conclusion

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

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

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

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Novavax, Inc. NVAX Stock News

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





NVAX Climbs Ahead Of Update

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




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

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

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

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

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What We’ll Be Watching For Ahead

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

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Dynavax Technologies Corporation DVAX Stock News

Dynavax Technologies Corporation (NASDAQ: DVAX) is off to an incredibly strong start in the trading session today, and for good reason. Early this morning, the company informed investors of an FDA advisory committee review of an experimental drug. Of course, this led to excitement among investors, sending the value of the stock toward the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:42), DVAX is trading at $9.80 per share after a gain of $0.20 per share (2.08%) thus far today.





DVAX Gains On FDA Committee Review

As mentioned above, Dynavax Technologies is having an incredibly strong day in the market today after announcing that the United States Food and Drug Administration has informed the company that the Vaccines and Related Biological Products Advisory Committee will review HEPLISAV-B(TM) at its scheduled meeting which will take place on July 28th.




This is interesting, as the PDUFA date for HEPLISAV-B is only a few weeks away, coming in at August 10th. The FDA intends to communicate specific questions with the VRBPAC and will draft an agenda for the questions, which will be on its website at least 48 hours prior to the meeting. In a statement, Eddie Gray, CEO at DVAX, had the following to offer:

The notification of a VRBPAC meeting comes as no surprise and thus we are prepared for it… The company looks forward to continuing work with the FDA through the review process and discussing HEPLISAV-B with the advisory committee.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on DVAX. In particular, we’re interested in following the meeting with the VRBPAC and excited to learn whether or not the vaccine will find its way to approval, and subsequently, commercialization. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Thought Leader Discussions

Gevo, Inc. GEVO Stock News

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