Biotech

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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!

Oncosec Medical Inc. ONCS Stock News

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

ONCS Advances With Novel Platform

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

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

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

OncoSec’s Approach Makes A Difference

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

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

The ImmunoPulse® Effect; A Key Advantage

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

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

All Signs Point To Yes

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

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

ONCS On The Fast-Track

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

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

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

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

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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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Delcath Systems, Inc. DCTH Stock News

Delcath Systems, Inc. (NASDAQ: DCTH) is having a relatively strong start in the pre-market trading hours this morning. However, at the moment, investors are frustrated, and for good reason. If you’ve followed CNA Finance recently, you’ve seen a lot of coverage on the stock, looking at it from the prospective of investors. At the end of the day, the reverse split has become more and more concerning over the past few months. Today, we’ll talk about the story and the latest information we know thus far. Before we do, a special thanks goes out to our friends at Trade Ideas for being the first to alert us to today’s gains. Currently (8:08), DCTH is trading at $0.13 per share after a gain of $0.01 per share or 4.50% thus far today.





So… What Reverse Split Are We Talking About With DCTH?

As mentioned above, investors have been frustrated with Delcath Systems, and most of that frustration stems from the company’s plans to move forward with a reverse split. However, in order to move forward with the RS, the company needs its investors to vote yes on the split, and it doesn’t look like that’s going to happen.




Ultimately, this year, the company has made multiple attempts at a reverse split, and this time around, the company may have pushed on investors a bit too hard. Ultimately, since the company couldn’t convince investors to vote yes by the first deadline, the deadline on the vote was moved to September 7th, 4 days ago. While waiting on this deadline, investors complained about several calls coming from various phone numbers. These calls were apparently call center representatives that were hired by DCTH in order to coerce investors to vote “Yes” on the split. Unfortunately, these reps were a bit pushy, and after listening to one of the calls personally, it’s clear that bullying tactics were used in order to flip votes.

It’s Clear The Vote Was No Yet Again

So far DCTH hasn’t come out and told investors whether or not the RS was voted to go through. However, if I was a betting man, I’d bet that the investors voted against the reverse split. There are a couple of reasons for my opinion here. Here’s how I see it…

  • Investors Themselves – First off, from the emails and StockTwits messages that I’ve received from investors surrounding the potential Delcath Systems reverse split, it’s clear that investors are largely against the reverse split. Considering that these same investors would have to vote yes in order for a RS to take place, and investors don’t seem to be willing to do so, it only makes sense that a no vote would be the result.
  • The Company – At this point, it has become pretty clear that investors have shot down the idea of an RS. The biggest reason is the company. If the RS was voted for, the company would have had a press release out by now, talking about the $13.7 million this would open up and the debt the reverse split would extinguish. However, for some time now, it seems as though DCTH has been a turtle, hiding in its shell until it had something good to tell investors. Well my friends, the turtle has yet to poke its head out of the shell. Unfortunately, there has been no news. Considering the fact that the company is so quiet, it only makes sense that the RS was voted against and the company is trying to figure out what their plan will be moving forward before addressing investors. While I don’t agree with this practice, it seems to be the status quot for DCTH.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will keep a close eye on DCTH. In particular, we’re interested in following the story to see if our prediction that the RS was voted down is correct. We’re also interested in seeing what the company does next as we believe that Chapter 11 bankruptcy is the most likely outcome if the RS was indeed voted down as we expect. 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) announced some big news yesterday. According to the announcement, the company has completed a key meeting with the United States Food and Drug Administration. Here’s what you need to know about the ADMD release…





ADMD Announces Completion Of FDA Meeting

As mentioned above, Advanced Medical Isotope Corp. recently released some big news. The company announced that it has completed its meeting with the FDA regarding pre-submission and a regulatory pathway surrounding RadioGel(TM).




ADMD said that the FDA was incredibly helpful through the meeting. The FDA also provided 14 pages of comments prior to the meeting with insights and clarifications during the the meeting. In their press release, the company said that the FDA’s recommendations are being incorporated into the testing plans. It is expected that the bench-top testing will begin late September.

The company also said that detailed animal study plans will be sent back to the FDA for a final review, as it is important that the FDA agrees with the plans before they are conducted. This will ultimately increase the probability that the data will be accepted as adequate to allow the company to move forward with the first clinical studies surrounding RadioGel in humans. ADMD said that the FDA has also agreed to follow-up communications with their experts on specific topics, helping to further ensure that the testing aligns well on complex topics and expectations of the FDA.

During the meeting, ADMD requested that the FDA provide De Novo reclassification as a Class II device based on the risks associated with the device. If this classification is achieved, the path toward regulatory approval will be faster and less onerous than a Premarket Approval, or PMA. To this, the FDA responded that they would need to see the data from pre-clinical testing before making a decision on this classification. This will give the FDA the ability to balance the therapeutic value against risks associated with the device.

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What We’ll Be Watching Moving Forward

Moving forward, the CNA Finance team will continue to keep a close eye on ADMD. In particular we’re interested in following the company’s ongoing work to bring RadioGel to the market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Cancer Genetics CGIX Stock News

Cancer Genetics Inc (NASDAQ: CGIX) released some big news this morning. The company announced that it will soon be providing a presentation for investors. Of course it is highly advised that if you already do invest in, or are considering investing CGIX, that you pay close attention to this presentation.





CGIX To Present At Rodman & Renshaw

As mentioned above, Cancer Genetics announced early this morning that it intends to give a presentation to investors relatively soon. The company is a leader in enabling precision medicine for oncology through molecular markers and diagnostics. The presentation will be featured at the 19th Annual Rodman & Renshaw Global Investment Conference, which is sponsored by H.C. Wainwright & Co., LLC. The conference will be held from September 10th to September 12th at the Lotte New York Place Hotel in New York City.




During the presentation, Panna Sharma, CEO at CGIX, will be providing an overview of the company’s business. As a presenter at the Rodman & Renshaw Global Investment Conference, the company will have the ability to participate in one-on-one meetings with investors who are registered to attend the conference. The presentation will take place on Monday, September 11, 2017, at 3:25 p.m. Eastern Time. If you would like to listen in on the presentation, you can do so by clicking here.

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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 CGIX. In particular we’ll be following the presentation to be given at the Rodman & Renshaw Global Investment Conference and advise that all investors or potential investors in the company do the same. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Interpace Diagnostics Group Inc IDXG Stock News

Interpace Diagnostics Group Inc (NASDAQ: IDXG) announced yesterday that it will soon be giving a presentation. Of course, it is advised that if you are an investor in the company or are considering investing, you follow the presentation, as key updates with regard to IDXG will be released.





IDXG To Present At Rodman & Renshaw

As mentioned above Interpace Diagnostics Group made an announcement yesterday via press release that it would be giving a presentation relatively soon. The company, focused on providing clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis, will be featured as a presenting company at the 19th Annual Rodman & Renshaw Global Investment Conference. The conference is sponsored by H.C. Wainwright & Co., LLC. and will be held beginning September 10, 2017 and ending September 12, 2017 at the Lotte New York Palace Hotel in New York City.




The presentation offered by IDXG will be provided by Jack Stover, President and CEO of the company. In the presentation, Stover will provide an overview of operations. Also, this will give the company the opportunity to participate in one-on-one meeting with investors that are registered to join the conference. The IDXG presentation will take place on September 11, 2017, at 4:40 p.m. Eastern Time.

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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 IDXG. In particular, we’re interested in following the presentation. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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MannKind Corporation MNKD Stock News

MannKind Corporation (NASDAQ: MNKD) released news today that shows that the company has a heart for those in need. Not only that, this news was a creative and philanthropic way of getting rid of Afrezza stocks that are going out of date. Here’s what’s going on…





MNKD Responds To Hurricane Harvey With Afrezza®

As mentioned above, MannKind has found a way to unload its Afrezza that is going to expire soon. The company announced today that it has shown its support for victims of Hurricane Harvey with a donation of Afrezza® inhalation powder. It is expected that the donation will be shipped this week to Insulin for Life USA, Inc. This is a non-profit organization designed to aid those living with diabetes.




MNKD made no small donation either. The company announced that it has authorized more than 27,000 cartridges of insulin for the donation to Insulin for Life USA. In a statement, Michael Castagna, CEO at MNKD, had the following to offer:

In times of crisis, many of us rely on our good health to help us get to better days… Among the millions of residents impacted by Hurricane Harvey are people who must manage their diabetes to maintain good health – but are separated by circumstances from their supplies. Extending a helping hand is consistent with our company’s values, and simply the right thing to do.

When it comes to rebuilding a life following a major event like Hurricane Harvey things rarely go according to schedule… We hope that our support provides some relief to those in need during such a challenging time.”

In Other News

While the news of the donation is incredibly positive news, there has been a bit of other news surrounding MNKD recently. In fact, many are suggesting that the company will soon be taken over by either Amgen or Merck & Co. At the moment, this is nothing more than a rumor. There has been no confirmation on either side that insinuates that either of these companies are interested in taking MNKD over. Nonetheless, it wouldn’t be out of the question, as both companies have the potential to benefit greatly from the assets that MannKind has to offer.

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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 MNKD. In particular, we’re interested in following the company through the continued commercialization of Afrezza as sales continue to pick up. We’re also interested in seeing the new commercial ads on major networks and excited to see how sales go once this starts. Finally, we’ll follow the story with regard to the potential takeover of the company. We’ll continue to follow the news closely and bring it 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...