Authors Posts by Joshua Rodriguez

Joshua Rodriguez

3142 POSTS 446 COMMENTS
Hey everyone, I'm Joshua Rodriguez. I'm the founder of CNA Finance as well as several other sites. If you'd like to connect with me, follow me on or Twitter! I'd love to see ya there. Also, if you're looking for top quality content for your blog, news outlet, or any other website for that matter, please reach out to me at Info@CNAFin.com! Legal Disclaimer - CNA Finance is NOT an investment advisor. All investment decisions should be well thought out and made with the help of a an investment advisor. For our full legal disclaimer, please scroll to the bottom right of this page.

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Green Spirit Industries GSRX Stock News

Green Spirit Industries Inc (OTCMKTS: GSRX) made a key announcement yesterday surrounding their plans of constructing 5 medical marijuana dispensaries in Puerto Rico. In the update, the company informed investors that current construction projects surrounding these goals remain on track. Here’s what we saw…





GSRX Announces That Construction Remains On Track

As mentioned above, Green Spirit Industries made a key announcement yesterday surrounding their goal of building 5 medical marijuana dispensaries in Puerto Rico. The announcement came through the company’s wholly-owned subsidiary known as Project 1493, LLC. According to the announcmeent construction of three of its planned medical cannabis dispensary locations in Puerto Rico remains on track following Hurricane Irma. All three of these dispensaries are still expected to open in the fourth quarter of this year. Currently, 3 of the dispensaries are under construction and GSRX plans on starting construction of the fourth dispensary in Isla Verda as well as the fifth in Fajardo in the coming weeks. In a statement, Les Ball, CEO at GSRX, had the following to offer…




We are grateful that this island and its people were spared the worst of Irma, and our prayers are with other members of our Caribbean island family who suffered tragic loss of life and monumental destruction… We remain united with our neighbors here, and are committed to bringing our products and services to those patients in Puerto Rico who are awaiting the opening of our dispensaries, as quickly as possible. Our proposed locations are undamaged, and construction has resumed.

We encourage anyone who is able to lend assistance to the people of those Carribean islands that were hit the hardest to do so. News reports are showing how Puerto Rico is welcoming evacuees from neighboring St. Thomas and St. Marteen, while private citizens here have been taking much-needed supplies by personal watercraft from Fajardo to St. Thomas, and returning with boatloads of evacuees. And Richard Branson, whose own Necker Island was left in shambles, is mobilizing to help with relief on neighboring Carribean islands. Together, we will all rebound and recover from Irma, and will emerge stronger than ever.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to watch GSRX incredibly closely. In particular, we’re interested in following the company’s work with regard to their plans of constructing the dispensaries in Puerto Rico and are excited to see the result as they come. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Advanced Medical Isotope Corporation ADMD Stock News

Advanced Medical Isotope Corp. (OTCMKTS: ADMD) released some big news yesterday! The company announced that it has had its first discussions with private animal consortiums to utilize RadioGelTM. This is a huge step in the right direction. Here’s what’s happening:





ADMD Holds First Talks With Private Animal Consortiums

As mentioned above, Advanced Medical Isotope made a major leap with an announcement yesterday surrounding their goal of bringing RadioGel to market for the treatment of skin cancer. The company announced yesterday that it has held its first discussions with private animal consortiums in order to prove safety and effectiveness of the product through testing at four university veterinary hospitals.




By taking advantage of access to private veterinary clinics, the company will be able to form business arrangements with large consortiums of private clinics in a cost-effective way. The company has had conversations with Veterinary Cancer Group and with VCA Inc. with the goal of gaining firsthand information on the steps required to market RadioGel in the commercial sector. With 55 veterinary centers that feed into 3 specialty clinics. VCA has 820 clinics in the United States and Canada with 25 specialty treatment centers.

According to the company’s press release, both consortiums have expressed a strong opinion with regard to the importance of learning from testing that the company is sponsoring at university veterinary centers. They have also encouraged ADMD to publish the results in a scientific journal. In fact, VCG expressed interest in teaming up with the universities by conducting some of the testing within their own facilities.

With such interest in the veterinary space, ADMD will likely have all it needs in order to move through the non-human testing phase surrounding this potentially game-changing treatment. Ultimately, this brings them one step closer to testing in humans, and their ultimate goal of bringing the treatment to the regulatory approval under the skin cancer indication.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on ADMD. I particular, we’re interested in following the ongoing efforts surrounding RadioGel and excited to see where this treatment goes as it continues through development. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Top Ships Inc TOPS Stock News

Top Ships Inc (NASDAQ: TOPS) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that it has entered into a timed charter and loan agreement. Of course, this led to excitement among investors, leading to gains in the market. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:17), TOPS is trading at $0.66 per share after a gain of $0.28 per share or 74.50% thus far today.





TOPS Gains On Charter And Loan Agreement

As mentioned above, Top Ships is having an incredibly strong day in the market today after announcing that it has entered into a partnership and loan agreement. The agreement surrounds a ship that is expected to be delivered by Hyundai in the third quarter of 2018. At this time, M/T Eco Palm Desert will enter into a time charter employment with Central Ship Chartering Inc, a related party. The agreement will have a term of 3 years. Following the initial 3 year period, the charter has the option to extend the firm employment period by an additional two years. It is expected that gross revenue surrounding the time charter will reach up to $27.5 million. This figure includes optional periods.




On top of the time charter agreement, the company also entered into a bank loan facility with a European bank for the financing of Eco Palm Desert. The agreement will give the company $23.5 million to work with. In a statement, Evangelos Pistolis, President and CEO at TOPS, had the following to offer…

The total gross revenue backlog for the fixed charter period of all of the Company’s operating fleet stands at about $106 million and when adding the 50% of our joint venture vessels it increases to about $122 million, with cashflow visibility reaching into 2021. Our business strategy continues to be focused on further expanding our fleet as it is important that we can achieve a certain critical mass in terms of fleet size with an aim to maximize our operational efficiencies and synergies.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on TOPS. In particular, we’re interested in following the news surrounding the vessel that’s coming soon and keeping an eye on the operation surrounding the vessels that are currently in use. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Halozyme Therapeutics, Inc. HALO Stock News

Halozyme Therapeutics, Inc. (NASDAQ: HALO) is up big in the market early on this morning, and for good reason. An announcement was made with regard to a key partnership, leading to excitement among investors and sending the stock toward the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:33), HALO is trading at $15.94 per share after a gain of $2.76 per share or 20.93% thus far today.





HALO Gains On Partnership News

As mentioned above, Halozyme Therapeutics is having an overwhelmingly strong start to the trading session this morning after the company announced a couple key partnerships. The company announced early this morning that it would be licensing its drug delivery technology to both Bristol-Myers Squibb (BMY) and Swiss pharmaceutical company, Roche in two separate collaborations.




As a result of the licensing agreements, HALO raised its 2017 revenue forecasts. The company now expects that revenue for the full year will come in between $245 million and $260 million. That’s a big jump from previous guidance of $115 million to $130 million.

With regard to the licensing agreements, HALO will be bringing in $135 million in upfront payments. $105 of which will come from BMY while the other $30 million will come from Roche. The technology licensed is the Enhanze technology, which is designed to help speed up the administration of injectable drugs.

Moving forward, Halozyme could end up bringing in an additional $160 million from both deals combined. These funds will be associated with milestones including development, regulatory and sales-based goals.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on HALO. In particular, we’re interested in watching the continued work surrounding Enhanze and excited to see the result of the collaborations mentioned above. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Atossa Genetics Inc ATOS Stock News

Atossa Genetics Inc (NASDAQ: ATOS) is having an incredibly strong time in the market in the pre-market hours this morning. Through a search on various PR services, the company’s website, and search engines, we were unable to find anything new. However, we were able to find a rumor that broke early this week that seems to be the cause of gains considering comments on message boards around the web. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:03), ATOS is trading at $0.78 per share after a gain of $0.09 per share or 12.39% thus far today.





ATOS Continues Upward On Rumors

As mentioned above, Atossa Genetics is having a pretty strong start in the pre-market hours this morning as investors seem to be looking back to rumors that hit the wire early this week. The rumors suggest that Merck & Co has been in meetings to discuss a potential partnership surrounding the pipeline drug Endoxifen following a successful Phase 1 clinical trial. According to unnamed sources, Merck is very positive surrounding the potential partnership as it would add another dimension to the company’s current breast cancer drug profile. ATOS and MRK supposedly met on Monday at first and it is expected that more meetings will be taking place today and tomorrow.




As is always the case when we talk about rumors, it’s important that I mention that rumors happen all the time in the market. Very few of these rumors hold any validity. While this particular rumor comes with quite a bit of detail and seems to be pretty valid, it’s important to keep in mind that it is still a rumor, and therefore, it may be false. So, if you’re going to trade on this news, please be sure to do so with caution.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on ATOS. In particular, we’re interested in following the story to see if MRK does indeed sign a partnership agreement with the company. Nonetheless, we’ll continue to follow the news and bring it to you as it breaks.

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Seadrill Ltd SDRL Stock News

Seadrill Ltd (NYSE: SDRL) is having an overwhelmingly positive day in the market today after announcing that it has reached a restructuring agreement following the news of Chapter 11 bankruptcy. While the deal all but wipes shareholders out, excitement that the company will survive seems to be pushing the stock toward the top. As is nearly always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:33), SDRL is trading at $0.27 per share after a gain of $0.05 per share or 19.81% thus far today.





SDRL Announces Restructuring Agreement

As mentioned above, Seadrill is having an incredibly strong day in the market after announcing that it has filed for Chapter 11 bankruptcy after closing a deal with banks and a minority bondholder. As a result of the deal, the company will receive $1 billion in new capital as well as extend or convert about $8 billion of loans into equity in the company.




According to the terms of the agreement, SDRL will be receiving $860 million in secured loans. On top of that, the company will be getting an additional $200 million through the sale of new equity. Bank lenders have also agreed to defer maturities on all secured credit facilities, which come to a total of $5.7 billion. These maturities will be deferred until the year 2020 and debt covenants have been rewritten. Finally, SDRL will be asking its unsecured creditors to convert $2.3 billion of unsecured bonds and other unsecured claims into a 15% equity stake in the company.

Shareholders All But Wiped Out

While the restructuring agreement will allow Seadrill to stay alive, shareholders have been all but wiped out in the deal. In fact, following the agreement, the shareholders will be left with only 2% of the post-restructuring company. While that’s a big cut to ownership, the company’s largest shareholders have given support to the deal and have even agreed to new capital investments.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on SDRL. In particular, we’ll be following the company through the restructuring process and interested to see where things go from here. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Delcath Systems, Inc. DCTH Stock News

Delcath Systems, Inc. (NASDAQ: DCTH) is having a rough day today after announcing that the company would be relisted on the OTC markets following a plan to go through a reverse split that was voted down. As is normally the case, our partners at Trade Ideas were the first to alert us to the declines. At the moment (8:01), DCTH is trading at $0.10 per share after a loss of $0.03 per share or 23.26% thus far today.

Nonetheless, that’s not why I’m writing this post today. Today, I’d like to discuss a 10K that clearly showed some major issues at the company and ultimately warn investors that even the management team doesn’t think things are going to go well. First and foremost, a special thanks goes to one of our readers, Dave H, who has been emailing me back and fourth, and ultimately was the person that brought this information to my attention. In fact, he even sent a PDF copy of the 10K highlighting the areas that were a cause for concern. With that said, thank you Dave for being an active part of the CNA Finance community and looking out for the best interest of investors!





Serious Concerns With Regard To Ability To Continue Operations

In the 10K, dated 3/29/2017, DCTH offered the following, suggesting that there is substantial doubt with regard to their ability to stay afloat as a business. In fact, the company even admitted that it’s “likely” that holders of common stock will lose all of their investment Here’s the quote from the SEC filing…

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. Our independent registered public accounting firm issued a report dated March 28, 2017 in connection with the audit of our financial statements as of December 31, 2016, which included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. In addition, our notes to our financial statements for the year ended December 31, 2016 included a disclosure describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment.”

DCTH Has Very Little Control Over CHEMOSAT/Melphalan/HDS

Further into the 10K, it becomes clear that the products the company is taking part in have some serious issues. Ultimately, DCTH has very little control over the production of their products, which could lead to long delays in obtaining key components of their products. Here’s what they had to offer in the 10K:

We purchase components for CHEMOSAT/Melphalan/HDS from third parties, some of which are sole-source suppliers. The components of CHEMOSAT/Melphalan/HDS, including catheters, filters, introducers and chemotherapy agents, must be manufactured and assembled in accordance with approved manufacturing and predetermined performance specifications and must meet cGMP and quality systems requirements. Some states also have similar regulations. Many of the components of CHEMOSAT/Melphalan/HDS are manufactured by sole-source suppliers that may have proprietary manufacturing processes. If we or any of our suppliers fails to meet those regulatory obligations, we may be forced to suspend or terminate our clinical trials, and, once a product is approved for marketing, the manufacture, assembly or distribution thereof. Further, if we need to find a new source of supply, we may face long interruptions in obtaining necessary components for CHEMOSAT/Melphalan/HDS, in obtaining FDA or foreign regulatory agency approval of these components and in establishing the manufacturing process, which could jeopardize our ability to supply CHEMOSAT/Melphalan/HDS to the market.




We do not have written contracts with all of our suppliers for the manufacture of components for CHEMOSAT/Melphalan/HDS. We do not have written contracts with all our suppliers for the manufacture of components for CHEMOSAT/Melphalan/HDS. If we are unable to obtain an adequate supply of the necessary components or negotiate acceptable terms, we may not be able to manufacture the system in commercial quantities or in a cost-effective manner, and commercialization of CHEMOSAT/Melphalan/HDS in the EEA may be delayed. In addition, certain components are available from only a limited number of sources. Components of CHEMOSAT/Melphalan/HDS are currently manufactured for us in small quantities and we may require significantly greater quantities to further commercialize the product. We may not be able to find alternate sources of comparable components. If we are unable to obtain adequate supplies of components from our existing suppliers or need to switch to an alternate supplier and obtain FDA or other regulatory agency approval of that supplier, commercialization of CHEMOSAT/Melphalan/HDS may be delayed.”

The Company Has Little By Way Of Marketing Capabilities

In their 10K, DCTH made it clear that they have no idea how to market their products. This is a major concern. After all, without marketing, sales will be a drag, and it looks like that’s exactly what the company is setting up for. Here’s the quote from the figurative horse’s mouth:

We have limited experience in marketing and commercializing our products, and as a result, we may not be successful in commercializing CHEMOSAT in the EEA. We have not previously sold, marketed or distributed any products and have limited experience in building a sales and marketing organization and in entering into and managing relationships with third-party distributors. Even though we have obtained the right to affix the CE Mark, we currently have limited sales, marketing, commercial or distribution capabilities in any countries in the EEA. In order to pursue our strategy to commercialize CHEMOSAT in the EEA, we must acquire or internally develop a sales, marketing and distribution infrastructure and/or enter into strategic alliances to perform these services. The development of sales, marketing and distribution infrastructure is difficult, time consuming and requires substantial financial and other resources. If we cannot successfully develop the infrastructure to market and commercialize CHEMOSAT, our ability to generate revenues in the EEAmay be harmed, and we may not generate sufficient revenue to sustain our business or we may be required to enter into strategic alliances to have such activities carried out on our behalf, which may not be on favorable terms.”

Competition Could Prove To Be An Issue

Further into the 10K, DCTH explains that patents are limited with regard to the protection and the lifespan of protection that they offer. Ultimately, the company made it clear that they are subject to competition from generic versions of their methods and devices.

Our success depends in part on our ability to commercialize CHEMOSAT/Melphalan/HDS prior to the expiration of our patent protection. Due to the uncertainty of the patent prosecution process, there are no guarantees that any of our pending patent applications will result in the issuance of a patent. Even if we are successful in obtaining a patent, patents have a limited lifespan. In the United States, the natural expiration of a utility patent typically is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our CHEMOSAT/Melphalan/HDS methods and devices, we may be open to competition from generic versions of such methods and devices.”

DCTH Does Not Own Some Key Patents, They Are Licensed From A Third Party

Another key issue here is the fact that Delcath Systems doesn’t seem to own patent rights to key components of their products. These patents are licensed by DCTH, but this could be a major concern if these relationships are not upheld.

We maintain a patent license arrangement with a third party, and our future business may depend, in part, upon the maintenance of that arrangement. Certain aspects of our next generation products may be covered by United States patents and United States patent applications owned by a third party and exclusively licensed to us. If we breach the terms of the license agreement, the license may be terminated by the licensor. If we do not meet certain commercialization obligations by 2019, the license may be converted to a non-exclusive license by the licensor. We cannot guarantee that the license will not be terminated or converted in the future. Without the patent license we will not be able to prevent others from practicing the technology covered by the licensed patent. Moreover, without the patent license, we may be subject to allegations of patent infringement by the patent owner. We cannot guarantee that the third party will fulfill its responsibilities under the license arrangement.”

Management Gives Stockholders The Middle Finger!

This one is just as surprising as the rest, if not more so. DCTH has moved forward with anti-takeover provisions, meaning that a takeover is unlikely to say the least. On top of that, they have put provisions in place that “make it more difficult for [their] stockholders to replace management.” So essentially, the snippet below says that management will do what they want with little opportunity for recourse given to investors.

Anti-takeover provisions in our Certificate of Incorporation and By-laws may reduce the likelihood of a potential change of control, or make it more difficult for our stockholders to replace management. Certain provisions of our Certificate of Incorporation and By-laws could have the effect of making it more difficult for our stockholders to replace management at a time when a substantial number of our stockholders might favor a change in management. These provisions include: • providing for a staggered board; and • authorizing the board of directors to fill vacant directorships or increase the size of our board of directors. Furthermore, our board of directors has the authority to issue up to 10,000,000 shares of preferred stock in one or more series and to determine the rights and preferences of the shares of any such series without stockholder approval.Any series of preferred stock is likely to be senior to the common stock with respect to dividends, liquidation rights and, possibly, voting rights. Our board’s ability to issue preferred stock may have the effect of discouraging unsolicited acquisition proposals, thus adversely affecting the market price of our common stock.”

Assets Up For Grabs

The company goes further to explain that their assets are essentially owned by their note holders. In fact, if the company defaults on obligations to these obligations, the note holders have rights to all assets of the company. Here’s the quote:

Our obligations to the holders of our notes are secured by a security interest in substantially all of our assets, so if we default on those obligations, the note holders could foreclose on our assets. Our obligations under the notes and the transaction documents relating to the notes are secured by a first priority security interest in substantially all of our assets. As a result, if we default under our obligations under the notes or the transaction documents, the holders of the notes, acting through their appointed agent, could foreclose on their security interests and liquidate some or all of these assets, which would harm our business, financial condition and results of operations and could require us to reduce or cease operations.”

Ability To Continue Is A Growing Concern

In the 10K, the company blatantly explains that the independent registered public account firm they hired has serious concerns with the company’s ability to continue in business from a financial standpoint.

Our independent registered public accounting firm has issued its report dated March 28, 2017 in connection with the audit of our financial statements as of December 31, 2016 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. In addition, our notes contained in this Annual Report on Form 10-K for the year ended December 31, 2016 include a disclosure describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. Our financial statements as of December 31, 2016 have been prepared under the assumption that we will continue as a going concern. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.”

DCTH Has Sold Some Of The Little IP It Has

Further into the 10K, Delcath Systems made it clear that while they have little intellectual property, what they do have is up for sale. Strangely enough, it recently sold some of this IP to Delcath Holdings Limited. Considering the name of the purchaser, something smells fishy!

On January 1, 2012, Delcath Systems, Inc. sold a portion of its intellectual property to Delcath Holdings Limited resulting in a taxable gain of $15.8 million in the U.S. based on the fair market value of the intangible that was transferred. The arms-length price, which was determined in accordance with Section 482, is a significant accounting estimate. The gain is deferred under U.S. GAAP principles until the asset is sold outside of the consolidated financial statements. The remaining deferred gain on the intercompany sale of intangible assets is $4.4 million and $6.7 million as of December 31, 2016 and December 31, 2015, respectively.”

Money Is A Big Problem

While management at DCTH pays themselves exorbitant salaries, they clearly understand that they are doing so at the cost of investors. The following paragraph says it all.

The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.”

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What We’ll Be Watching For Moving Forward

Moving forward, the CNA Finance team will continue to keep a close eye on DCTH. At this point, we’re essentially watching to see how long it takes for the company to crumble. With no RS, funding isn’t available and with protection from takeovers, that’s likely not an option either. We’re also doing some serious digging into the relationship between Delcath Systems and Hudson bay and advise all investors to do so as well. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!

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Aytu BioScience AYTU Stock News

Aytu Bioscience Inc (OTCMKTS: AYTUD) is in a strong position to take advantage of recent news that sent Acrux (ASX: ACR) plummeting. Last week, Eli Lilly (NYSE: LLY) announced that the company ended it’s agreement with Acrux surrounding Axiron, a testosterone replacement therapy for men that is applied to the man’s armpits. This creates a massive opening that AYTUD is likely to take advantage of. Below we’ll talk about the termination of the agreement, what the news means for Aytu Bioscience, and what we’ll be watching for ahead.

Eli Lilly Ends Agreement With Acrux

As mentioned above Acrux took a dive in the market last week as news broke that the company and Eli Lilly have agreed to terminate their license deal surrounding the testosterone replacement therapy, known as Axiron.

The license deal was signed back in 2010, proving to be one of the largest, if not the largest licensing deal that has ever been signed by an Australian biotechnology company. Under the terms of the deal, Acrux would receive up to $335 million with the potential to earn royalties from Eli Lilly. In exchange, Eli Lilly obtained exclusive rights to commercialize the treatment.

Nonetheless, the deal is now done. On September 6th, it was announced that both companies involved reached an agreement to terminate the license agreement.

Why This Is A Big Positive For AYTUD

While the news of the license agreement termination proved to be bad news for Acrux, one man’s trash is another man’s treasure, and as the saying suggests, this bad news for Acrux could turn out to be a goldmine for Aytu Bioscience. The reason is simple. At the end of the day, the termination of the licensing agreement is symbolic of a bellhop opening the door for AYTUD’s Natesto to enter a massive market with virtually no competition.

When I say massive, I mean it. In fact, the termination of the license agreement means that approximately $140 million in Axiron net sales is up for grabs in the testosterone replacement market. Considering Natesto’s unique product profile, it’s highly likely that AYTUD will be the company that gets their hands on those sales dollars!

Think about it this way, considering the termination of the agreement between Eli Lilly and Acrux, there will be no further promotion of Axiron. Considering that this was one of the primary sources of competition for Aytu Bioscience’s Natesto, Natesto is now virtually the only brand in the testosterone replacement therapy market that is being promoted. Considering the following, there’s no reason Natesto won’t be able to fill the void and gain market share as a result:

  • At the moment, Natesto is the only testosterone gel on the market that comes with no black box warning from the United States Food and Drug Administration; adding an insinuation of safety among users that no other therapy in its class can match.
  • Axiron was drippy solution, making a bit of a mess after application under the man’s arms – and subject to transferring that testosterone to the man’s female partner or young children living in the house. That is not the case with Natesto given its easy nasal administration, making it a far more user-friendly product.
  • The pharmacokinetic profile of Natesto is quite a bit better than that of Axiron, with higher Cmax and pulsed dosing between 2 and 3 times per day. Axiron’s single dose delivered the same steady-state of testosterone all day. This steady state of testosterone creates side effects that are both unhealthy and uncomfortable.
  • When compared to Axiron, Natesto has a faster rate of improvement in patients with regard to both mood and erectile dysfunction, and Natesto gets to a higher Cmax than Axiron – and does it in less time.
  • With Axiron now out of the way, and $140 million in market share up for grabs, AYTUD has the unique opportunity to entice large insurance players to pay attention to Natesto as insurers want rebates on safe and effective branded drugs of the like.

The Bottom Line

The bottom line here is that while the termination of the agreement between Eli Lilly and Acrux gave Acrux the blues, it opened a massive door for AYTUD. This gives Natesto an even stronger chance at taking a sizable share in a $2 billion market as one less big pharma competitor steps away. So, keep your eyes peeled as the opportunities for Natesto only continue to grow!

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Idera Pharmaceuticals IDRA Stock News

Idera Pharmaceuticals Inc (NASDAQ: IDRA) is having an incredibly strong start to the trading session this morning after announcing strong Phase 1/2 clinical data. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:55), IDRA is trading at $2.22 per share after a gain of $0.27 per share or 13.85% thus far today.





IDRA Gains On Positive Clinical Data

As mentioned above, Idera Pharmaceuticals is having an overwhelmingly strong start to the week this morning after releasing strong data from a Phase 1/2 clinical trial. The results came from the dose-selection phase of the ongoing trial, designed to investigate IMO-2125.




The IMO-2125-ipilimumab dose-selection phase was conducted with 18 patients. According to the release, each of these patients progressed on nivolumab or pembrolizumab. These patients were treated with IMO-2125 at doses ranging from 4 mg to 32 mg in combination with standard dosing of ipilimumab. According to the press release offered by the company, there were no dose-limiting toxicities seen and the maximum tolerated dose was not reached. However, the 8 mg IMO-2125 dose has been chosen for further development upon acceptable safety, clinical activity, and evidence for target engagement on several biopsies of the injected tumor and a distant metastasis. Here are the key findings IDRA released with regard to the trial:

  • Confirmed RECIST v1.1 response were observed in 4 of 9 subjects treated at the recommended dose of 8 mg.
  • 6 out of the 9 patients treated at the 8 mg dose experienced disease control.
  • IDRA said that a RECIST v1.1 PR of greater than 1 year duration is ongoing in patients treated with IMO-2125 4 mg.
  • IMO-2125, when combined with ipilimumab, proved to be well tolerated at all dose levels studied.
  • The treatment was also safely administered through the use of deep injection in patients lacking superficially accessible disease for injection.

In a statement, Adi Diab, M.D., lead trial investigator, assistant professor at the Department of Melanoma Medical Oncology, Division of Cancer Medicine at the University of Texas, MD Anderson Cancer Center, had the following to offer:

The majority of patients with solid tumors do not respond to anti-PD-1 therapy and the published response rate to ipilumab alone in anti-PD-1 refractory melanoma is only 10-13%; to be seeing 6 out of 9 patients experiencing clear disease control is extremely exciting…”

This statement was followed up by Joanna Horbin, M.B., Ch.B., CMO at IDRA. Here’s what she had to offer…

Based on these positive and encouraging response data in anti-PD-1 refractory melanoma, where the greatest need exists, we have expanded the target number of patients in the ongoing Phase 2 expansion, including broadening eligibility to patients who have received prior ipilimumab, including ipilimumamb/PD-1 inhibitor combination… We plan to start a Phase 3 trial in patients with PD-1 refractory melanoma in the first quarter of 2018. Preparations are well-underway for this global initiative which is addressing a major unmet need in melanoma. We are very encouraged by the enthusiasm of investigators to participate in the Phase 3 study.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on IDRA. In particular, we’re interested in following the ongoing work surrounding IMO-2125 as the treatment seems to be overwhelmingly promising. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Teva Pharmaceutical Industries Ltd (ADR) TEVA Stock News

Teva Pharmaceutical Industries Ltd (ADR) (NYSE: TEVA) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has named the long-term CEO, causing excitement among investors who are sending the stock toward the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:02), TEVA is trading at $17.61 per share after a gain of $2.11 per share or 13.61% thus far today.





TEVA Names Permanent CEO

As mentioned above, Teva Pharmaceutical Industries is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company has named Kåre Schultz as the new president and CEO. At the moment, Dr. Yitzhak Peterburg is still acting as the interim CEO as Schultz will need to relocate to the company’s headquarters in Israel.




Kåre Schultz brings quite a bit to the table for TEVA. He has a nearly 30-year history in the pharmaceutical industry. Most recently, Schultz served as the President and CEO at H. Lundbeck A/S. Before that, he served as the chief operating officer at Novo Nordisk. Investors are hoping that Schultz will help pull TEVA out of the rut they are in with regard to sluggish sales and large debt obligations associated with recent acquisitions. In a statement, Dr. Sol J. Barer, Chairman of Teva Pharmaceutical Industries’ Board of Directors, had the following to offer…

With extensive global pharmaceutical experience, a strong track record executing corporate turnaround strategies, driving growth and international expansion at low incremental cost and delivering on promises to shareholders, as well as a commitment to a culture of compliance Kåre is the right leader to take Teva to the next level.”

The above statement was followed up by Kåre Schultz himself, who had the following to offer…

I am honored to join Teva, an iconic company that I have long admired during my career. What drew me to Teva, and what makes Teva different from its peers, is its unique commitment to growing an extensive global reach while continuing to provide new and high-quality treatments for patients and an innovative culture for its employees. I am proud to be joining a company that helps millions of patients around the world on a daily basis with its broad range of generic and specialty drugs.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on TEVA. In particular, we’re interested in following the story surrounding Kåre Schultz and seeing how he changes the company for the better as the new president and CEO, leading the charge! Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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