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My guess is because the entire sector is down -- few biotechs are green today. Takes really strong news to overcome the sector sentiment.
Also, although shorts are down from about a year ago there is still a pretty high short position. Shorts always take advantage of a day like today.
http://www.nasdaq.com/symbol/ino/short-interest
I picked up a few more shares @ $4.30.
INO
Bought more at $18.30 before selling all @ $19.85. Took profits, but watching to re-enter if pulls back again.
NTLA
CRISPR hits a snag: Our immune systems may attack the treatment
By ANDREW JOSEPH @DrewQJoseph JANUARY 8, 2018
The CRISPR-Cas9 gene editing complex from Streptococcus pyogenes.
A new paper points to a previously unknown hurdle for scientists racing to develop therapies using the revolutionary genome-editing tool CRISPR-Cas9: the human immune system.
In a study posted Friday on the preprint site bioRxiv, researchers reported that many people have existing immune proteins and cells primed to target the Cas9 proteins included in CRISPR complexes. That means those patients might be immune to CRISPR-based therapies or vulnerable to dangerous side effects — the latter being especially concerning as CRISPR treatments move closer to clinical trials.
But researchers not involved with the study said its findings, if substantiated, could be worked around. (Papers are posted to bioRxiv before being peer-reviewed.) Many of the first planned CRISPR clinical trials, for example, involve removing cells from patients, fixing their DNA, and then returning them to patients. In that case, it’s possible that there will be few or no CRISPR proteins remaining for the immune system to detect.
They also noted that scientists are already studying other types of CRISPR that use different proteins, which could stave off the immune responses.
“At the end of the day, I’m not that concerned about it,” said Daniel Anderson of the Massachusetts Institute of Technology, who has studied the delivery of CRISPR therapies and who was not involved with the new study. “But we want to do some experiments to learn more.”
Related Story: Using CRISPR, scientists efficiently edit genome of viable human embryos
The new study should not put the brakes on developing CRISPR therapies, agreed Dr. Matthew Porteus of Stanford, a senior author of the paper and who is himself at work on a CRISPR-based therapy for sickle cell disease. But he said he and his colleagues investigated the immune issues because he felt they were being overlooked as the excitement around CRISPR grew.
“Like any new technology, you want to identify potential problems and engineer solutions for them,” Porteus said. “And I think that’s where we’re at. This is an issue that should be addressed.”
(Porteus and Anderson are both scientific founders of CRISPR Therapeutics, one of the most prominent companies exploring CRISPR-based therapies.)
Immune survey
CRISPR has gained fame in recent years as researchers have deployed it to correct an array of disease-causing mutations in cells in the lab and in animal models, with hopes that the same results can be achieved in people. There are different types of CRISPR systems, but the most well known is dubbed CRISPR-Cas9; it includes Cas9 proteins that cut DNA so that it can be edited. Cas9 proteins come from bacteria.
For the study, the researchers decided to check for immune signals against two of the most common types of Cas9 proteins used, those from the bacteria S. aureus (called SaCas9) and those from S. pyogenes (called SpCas9). In their samples of blood from 22 newborns and 12 adults, the scientists found that 79 percent of donors had immune proteins, called antibodies, against SaCas9, and 65 percent had antibodies against SpCas9.
The researchers then searched for immune cells called T cells. They discovered that about half of the donors had T cells that specifically targeted SaCas9, so that if the immune cells detected that protein on the surface of a cell, they would rally a response to try to destroy it. The researchers did not find anti-SpCas9 T cells, though they said the cells might still have been present.
It’s not surprising so many of the donors had antibodies and T cells against the Cas9 proteins, experts said. That simply means that those people had been exposed to the bacteria containing the proteins in the past, and other studies have found that, at any given time, 40 percent of people are “colonized” by S. aureus and 20 percent of schoolchildren have S. pyogenes. The bacteria only sometimes cause disease.
_______________________________________________
https://www.statnews.com/2018/01/08/immunity-crispr-cas9/
NTLA
In at $18.90. Got to believe the drop is over-reaction to the article.
RATINGS
Today
Consensus Rating: Buy
Consensus Rating Score: 2.67
Ratings Breakdown: 0 Sell Rating(s)
3 Hold Rating(s)
6 Buy Rating(s)
0 Strong Buy Rating(s)
0 Sell Rating(s)
Consensus Price Target: $30.00
Price Target Upside: 63.31% upside
https://www.marketbeat.com/stocks/NASDAQ/NTLA/
PTLA
FWIW:
Jim Cramer Advises His Viewers On Incyte And American Outdoor Brands
Craig Jones , Benzinga Staff Writer FOLLOW
January 08, 2018 7:17am Comments
Jim Cramer said on CNBC's "Mad Money" that Incyte Corporation
INCY is oversold. He would be a buyer of the stock.
_______________________________
https://www.benzinga.com/media/cnbc/18/01/10998447/jim-cramer-advises-his-viewers-on-incyte-and-american-outdoor-brands
I don't see over-sold on RSI nor Wm%(14). See over-bought on CCI(20)
INCY
Incyte and Syros Announce Global Target Discovery and Validation Collaboration Focused on Myeloproliferative Neoplasms
WILMINGTON, Del. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Incyte Corporation (INCY) and Syros Pharmaceuticals, Inc. (SYRS) announced today that the companies have entered into a target discovery, research collaboration and option agreement. Under the agreement, Syros will use its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative neoplasms (MPNs), and Incyte will receive options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets. Incyte will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets.
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180108005822/en/
“The discovery and development of novel therapeutic approaches to treat MPNs is an important area of focus at Incyte,” said Reid Huber, Ph.D., Chief Scientific Officer of Incyte. “Through this collaboration, we believe that Syros’ gene control platform will allow us to advance our understanding of the underlying biology of MPNs and potentially uncover new molecular targets for drug discovery.”
“Our gene control platform has broad applicability across diseases,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “By working with Incyte, a leader in the discovery, development and commercialization of therapies for MPNs, we aim to leverage the promise of our platform to benefit patients with diseases beyond our current areas of focus. Meanwhile, we can continue advancing our own pipeline to achieve our long-term goal of building a fully integrated company with therapies that make a profound difference for patients.”
Terms of the Agreement
Under the terms of the agreement, Incyte will pay Syros $10 million upfront – including $2.5 million in cash and $7.5 million in prepaid research and development (R&D) – and purchase a total of $10 million in Syros common stock at $12.61 per share.
Should Incyte exercise all of its options under the agreement, Syros could receive up to $54 million from Incyte in target selection and option exercise fees. For products resulting from the collaboration against each of the up to seven selected and validated targets, Syros could receive up to $50 million in development and regulatory milestones, as well as up to $65 million in commercial milestones. Syros would also be eligible to receive low single-digit royalties on sales of products resulting from the collaboration.
The transaction is effective immediately.
About Incyte Corporation
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
About Syros Pharmaceuticals
Syros is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of genes. Syros has built a proprietary platform that is designed to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, Syros’ gene control platform has broad potential to create medicines that achieve profound and durable benefit across a range of diseases. Syros is currently focused on cancer and monogenic diseases and is advancing a growing pipeline of gene control medicines. Syros’ lead drug candidates are SY-1425, a selective RARa agonist in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor in a Phase 1 clinical trial for patients with advanced solid tumors. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Mass.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether the collaboration will yield any validated targets, advance the understanding of MPNs or benefit patients; whether Incyte will exercise any of its options to exclusively license any such targets; and whether and when any of the target validation fee, options exercise fees, milestone payments or royalties under this collaboration will ever be paid by Incyte. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: research and development efforts related to the collaboration programs; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors; unanticipated delays; each company’s ability to compete against parties with greater financial or other resources; greater than expected expenses; and such other risks detailed from time to time in each company’s reports filed with the Securities and Exchange Commission, including the Form 10-Q for the quarter ended September 30, 2017 filed by each company. Each party disclaims any intent or obligation to update these forward-looking statements.
__________________________________________________________
View source version on businesswire.com: http://www.businesswire.com/news/home/20180108005822/en/
INCY
Inovio Receives Milestone Payment from MedImmune as MEDI0457 and Checkpoint Inhibitor Combination Trial in Head and Neck Squamous Cell Cancer Advances to Phase 2
First efficacy trial to evaluate Inovio’s cancer immunotherapy targeting HPV in combination with durvalumab
January 08, 2018 08:00 ET | Source: Inovio Pharmaceuticals, Inc.
PLYMOUTH MEETING, Pa., Jan. 08, 2018 (GLOBE NEWSWIRE) --
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today it has received a milestone payment from MedImmune as MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in combination with durvalumab (MEDI4736) satisfactorily completed the phase 1 safety review portion of the study and has advanced to the phase 2 efficacy stage of the trial. As part of a $700 million 2015 license and collaboration agreement, MedImmune, the global biologics research and development arm of AstraZeneca, is evaluating MEDI0457 in combination with durvalumab, its PD-L1 checkpoint inhibitor, in patients with recurrent/metastatic HPV-associated head and neck squamous cancer (HNSCC) in a clinical trial with an estimated enrollment of 50 patients.
Under the 2015 agreement, MedImmune acquired exclusive rights to Inovio's MEDI0457 immunotherapy. MEDI0457 targets cancers caused by human papillomavirus (HPV) types 16 and 18 which are responsible for more than 70 percent of cervical pre-cancers and cancers and are involved in the development of other tumors as well such as HNSCC. Within the broader license and collaboration agreement, MedImmune and Inovio will develop two additional DNA-based cancer therapy products not included in Inovio's current product pipeline, which MedImmune has exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.
Dr. Ildiko Csiki, MD, PhD, Inovio Vice President, Clinical Development said, “We are pleased to see this combination study advance to the efficacy portion of the trial. Published preclinical studies suggest that treatment with HPV targeted immunotherapeutic approach in combination with PD-1/PD-L1 inhibition may be synergistic, and potentially increase efficacy of checkpoint inhibitors.”
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “Inovio’s primary goal is to become the global leader in HPV-related disease treatment. Along with MEDI’s development of MEDI0457 for HPV-related cancer, Inovio’s VGX-3100, is currently being tested in global phase 3 pivotal trials for cervical pre-cancer as well as a treatment for vulvar and anal pre-cancers caused by HPV. Overall, these products could be well-positioned to comprehensively treat HPV-related diseases across the continuum of HPV infections from pre-cancerous conditions to cancer in both women and men.”
In a phase 1 study of MEDI0457 in 22 HPV-positive patients with HNSCC, Inovio has previously demonstrated that MEDI0457 generated robust antigen-specific CD8+ killer T cell responses in both tumor tissue and peripheral blood. One patient in that trial who initially displayed a slight increase in T cell immune responses developed progressive disease at 11 months into the study and subsequently received a PD-1 checkpoint inhibitor. The patient had a sustained complete response after only four doses of a checkpoint inhibitor, and continues on anti PD-1 therapy with no evidence of disease 18 months after initiation of the checkpoint inhibitor.
About MEDI0457 and VGX-3100
MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which MedImmune in-licensed from Inovio) is under evaluation by MedImmune to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (phase 3) and vulva (phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.
About Inovio Pharmaceuticals, Inc.
Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs, including the planned initiation and conduct of clinical trials and the availability and timing of data from those trials, and the sufficiency of our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, our Form 10-Q for the period ended September 30, 2017, and other regulatory filings we make from time to time. There can be no assurance that any product candidate in Inovio's pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and Inovio undertakes no obligation to update or revise these statements, except as may be required by law.
CONTACTS:
Investors: Ben Matone, Inovio, 484-362-0076, ben.matone@inovio.com
Media: Jeff Richardson, Inovio, 267-440-4211, jrichardson@inovio.com
_____________________________________________
http://globenewswire.com/news-release/2018/01/08/1285022/0/en/Inovio-Receives-Milestone-Payment-from-MedImmune-as-MEDI0457-and-Checkpoint-Inhibitor-Combination-Trial-in-Head-and-Neck-Squamous-Cell-Cancer-Advances-to-Phase-2.html
INO
Now you tell me! Just kidding. Seemed like a good point to protect earnings, but it did keep rising with the high volume before dropping back. Good company and will get back in. However, the recent 6 month daily chart shows it seldom stays green for three days and generally drops the next day after gains:
The total consensus price is $20 (don't sell it cheap)
Today
Consensus Rating: Buy
Consensus Rating Score: 2.82
Ratings Breakdown:
0 Sell Rating(s)
2 Hold Rating(s)
9 Buy Rating(s)
0 Strong Buy Rating(s)
Consensus Price Target: $20.00
Price Target Upside: 327.35% upside
__________________________________________
https://www.marketbeat.com/stocks/NASDAQ/INO/
INO
Sold @ $4.60. Looking to get back when/if there is a dip. Great news today.
INO
So many good things about the agreement, sure suggests a position of strength since Apollo is a potential buyer:
______________________________________________________________
Based on the new agreement, ApolloBio will make an upfront payment of $23 million (an increase from the previously announced amount of $15 million), as well as potential future payments up to $20 million upon meeting certain milestones. In addition, Inovio is entitled to receive double-digit tiered royalty payments on sales. As part of the new terms which replace the previous amendments to this agreement that were announced on November 2, 2017, the parties have agreed to terminate ApolloBio’s right to purchase Inovio stock. This collaboration of VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias (including cervical, vulvar and anal pre-cancers) and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants. The agreement also provides for potential inclusion of the Republic of Korea during the next three years.
_____________________________________________________________
INO
Inovio Poised For Breakthroughs In 2018 And Beyond
Jan. 1, 2018 11:25 AM ET|About: Inovio Pharmaceuticals, Inc. (INO)
Summary
Focus is on near term hidden value rather than trading technicals (e.g., up to 9 marketable vaccines and 3 priority review vouchers in 2018/2019).
We explore Inovio partnerships for 2018/2019 to unlock further hidden value.
Inovio is near a 52 week low with a ~$373 million market cap with opportunities worth multiples of that value.
Discussion
Many investors that look at Inovio see a 2020 market opportunity for Inovio’s flagship product (VGX-3100) for cervical dysplasia caused by HPV.
We present near-term opportunities for Inovio starting in 2018 and extending thru 2020 which many potential Inovio investors overlook. In order to understand the hidden opportunity one first has to look at the growth that occurred between 2014 and 2017 to setup for 2018:
Employees went from 86 (August 2014) to 271 (July 2017). (slide 40 Investor presentation)
San Diego office space has grown by ~51,000 square feet. Pennsylvania office space has grown by ~30,000 square feet (page 18)
Inovio has acquired needle-free injection technology and is planning on integrating that technology with electroporation to have next generation intradermal needle free delivery which will be perfectly suited for infectious diseases. Inovio’s top talent here includes:
Dr. Kate Broderick leadership with electroporation
Fluid dynamics experts from Texas Tech to optimize intradermal delivery.
The patent portfolio is several hundred strong with dozens added each year
Inovio ranked number 107 out of Deloitte’s Technology Fast 500 growth award.
We look at Inovio’s partnerships which unlock each of the hidden opportunities starting in 2018 with an understanding that the current Inovio market cap (~$373 million) is likely too low given these hidden opportunities.
Supplemental Information
Several of the topics discussed in this article go in to a level of details which are beyond the scope of a short article. The reader is encouraged to read the Supplemental Information here where more details exist beyond the scope of this short article.
Near Term Hidden Value (Up to 9 Marketable Vaccines and 3 Priority Review Vouchers)
In 2018 Plumbline Life Sciences (16.8% owned by Inovio) is expected to market 2 new vaccines (PLS-D5000 which is a dog version of Inovio’s Tert vaccine and PLS-D1000 for renal failure in dogs) in addition to expanding the market of a third already marketed DNA vaccine for pigs (LifeTide SW5). There are also indications that Plumbline Life Sciences may be readying 3 additional vaccines for market by end of 2019. See Supplemental Information for details.
The key here is that these 6 products represent royalties (due to Inovio owned patents), an ownership position by Inovio, and electroporation device sales by Inovio since the Plumbline products depend on Inovio EP. Three of these 6 products have the potential for sales in 2018. Three more have potential for sales by end of 2019.
Inovio will also license a 7th product to Plumbline for marketing at some point in the early 2020’s related to Foot and Mouth Disease
The FDA Emergency Use Authorization (EUA) has at least 3 vaccines (Ebola, MERS, Zika) and less likely a 4th (H7N9 influenza) which Inovio could bring to market over the next 3 years. An EUA approval could yield a priority review voucher (PRV) from the FDA which has a worth of roughly $350 million per voucher in recent history (roughly the same as current Inovio market cap per PRV and there are more than one PRV with potential in the near term). There are also a few vaccine types that Inovio works which may not qualify for an EUA but would qualify for a PRV including Dengue, Malaria, and Tuberculosis. One path that an EUA can take is by “animal rule” where a safety trial plus data from 2 animals is required to bring a solution to market.
Currently the Ebola vaccine from Inovio is the furthest along as a potential EUA. The Inovio Ebola vaccine is possible to go to an EUA in 2018 per Dr. Kim’s comments in 3rd Quarter 2016 conference call which state “The path for Ebola vaccine will likely involve the use of animal rule and we will look to get the clarity armed with our 200-patient study data in 2017”. It is speculation what an EUA approval for Ebola might look like in 2018 but one likely way that it could look is a US government stockpile order for somewhere between 50,000 doses and 200,000 doses along with an order from Inovio for electroporation devices to deliver those doses in case of an emergency.
The next most advanced candidate for EUA from Inovio is MERS. Associated with MERS is an “Advanced Biopharmaceuticals International Center of Support” (ABICS) hosted by VGXi (leading contract manufacturer of DNA plasmids) which Inovio partially owns and partners with. An EUA approval for MERS is possible in late 2018 or early 2019. Again it is speculation on how the rollout for an EUA for MERS would occur. But it is likely that vaccinating young dromedary camels which are the main carrier of MERS would occur in late 2018 possibly followed by either a stockpile order or a prevention order for humans in areas of the world where young dromedary camels exist. Associated with both camel and human vaccination of MERS is also a device delivery order from Inovio for electroporation devices to deliver the vaccines. Initial rollout for the Inovio MERS vaccine would be for the preventative version that Inovio develops. However, an Inovio therapeutic dMab solution may be available a couple of years later.
The Inovio Zika solution has the potential to go for general worldwide use in 2019 or 2020 by EUA. Please reference my article here for a detailed discussion. As with MERS the first EUA will likely be for a preventative solution. A couple of years later the therapeutic dMab version of Zika will be available. Zika has the potential for most doses required out of any EUA due to the worldwide presence of the Aedes aegypti mosquito that carries the disease. It likely will be debatable regarding the ability to give a Zika vaccine to a mother in pregnancy but Inovio will likely be well situated to prevent Zika based on data to date. A 40 person human trial completed in December, 2017 while a 160 participant trial has a completion date of June 2018.
Near Term Inovio Partnership Activity
In 2018 Geneos Therapeutics may be exciting to watch as it either performs an IPO spinoff of Inovio or makes further announcements as a fully owned Inovio subsidiary. Per the 3rd quarter 2016 earnings conference Dr. Kim stated “We (Inovio) incorporated a 100% owned subsidiary Geneos Therapeutics Inc to develop and commercialize neoantigen based personalized cancer therapies.” “Geneos plans to build its own team and independently secure operating capital, it will not use Inovio’s resources”. These statements imply funding from an outside source which likely implies a partner in the newly formed company. Possible partners for Geneos Therapeutics are discussed in the Supplemental Information about Inovio Partners. The neoantigen space which Geneos Therapeutics targets is the first entry in to the personalized medicine space by Inovio which should well complement the generalized therapies that Inovio already targets. Similar types of IPO’s in the personalized medicine space have been going for $115 million and $93 million. Depending on the partner and the scope of Geneos Therapeutics the value of a Geneos IPO has the potential for being worth more than that.
Medimmune partnership could yield rewards in 2018. The partnership is worth $727.5 million and a milestone payment is likely in 2018 with a value of potentially 10’s of millions of dollars for 2018 and follow up milestone payments expected in subsequent years.
ApolloBio partnership could yield rewards in 2018. There is a potential China market opportunity for Inovio for VGX-3100 (for cervical dysplasia) and potentially other indications if the People’s Republic of China (PRC) corporate and regulatory approvals occur. The partnership details will likely either be agreed or rejected soon and may involve an investment on the part of ApolloBio in Inovio stock. For 2018 the immediate benefit is the potential of money to Inovio to help fund 2018 activities if the deal can be agreed upon. Subsequent years can see additional benefits if and when Inovio products are approved for sale in China.
The Coalition of Epidemic Preparedness (CEPI) and DARPA P3 both have significant potential for offering large grants or even orders for Inovio vaccines or devices in 2018. Significantly CEPI already lists Inovio as a partner and DARPA P3 has invited Inovio to speak with them. Both programs have potential to move very fast once they get started because timelines on orders for both programs are on the order of weeks, not years. CEPI is driving towards a model of being able to target an infectious disease within 16 weeks of identification whereas DARPA P3 is driving towards a 60 day model. If these timelines are taken literally there is potential for products to be produced from these two partnerships within 2018 although more likely there will be grants offered in 2018 with potential products offered in the years following. DARPA has already granted $45 million to Inovio for preliminary work using Ebola as a target vaccine. And CEPI has declared that “finishing the job on Ebola” is a priority to CEPI whereby per the above section on EUA’s that is very possible to do within 2018. Please read the Supplemental Information for further details about these 2 exciting programs and how they may be connected to Inovio. 2018 should be exciting for both.
The Gates Foundation and the Penny Heaton Medical Research Institute (associated with the Gates Foundation) are two other avenues that grants may be possible particularly for tuberculosis which Inovio is involved with. The Gates Foundation has already provided $8.8 million in funding to Inovio and Inovio’s science partner (Wistar) for furthering Zika dMabs. There is an interesting story about how Gates, CEPI, Penny Heaton, Wistar, and Inovio could all be connected. Please read the Supplemental Information for details. For 2018 there is potential for the Gates Foundation to get further involved as these stories evolve
IVI (International Vaccine Institute) is sponsoring Inovio’s MERS vaccine. And perhaps equally as important the IVI has 3 Inovio board members on the IVI board of Trustees. Those board members include Dr. Adel A.F Mahmoud (Inovio board of directors), Mr. George Bickerstaff (Inovio board of directors), and Dr. Joseph Kim (CEO Inovio). IVI has a global footprint that includes South Korea, China, India, Brazil, and other Asian, African, and South American countries. In addition to MERS the IVI also has a focus on Dengue and “Aedes-transmitted Diseases”. That is convenient because Inovio’s dengue, Zika, and chikungunya vaccines fall in to this category of IVI focus. It is reasonable speculation that Inovio will launch some of these dMab candidates in 2018 and that IVI will help to contribute towards their cause.
Inovio mentions in its PR that Regeneron Pharmaceuticals is interested in solutions to rheumatoid arthritis. Per an earlier PR Inovio mentions that dMabs have the potential to solve rheumatoid arthritis. Dr. Kim during 3rd quarter 2017 conference call stated “We have our own version of Humira which is the largest selling rheumatoid arthritis (solution). I think it is a highest grossing pharmaceutical product today with over $10 billion sales”. One could speculate that Inovio could partner with Regeneron on a solution to rheumatoid arthritis in 2018 to meet Regeneron’s desired result. Inovio and Regeneron are already partnering on glioblastoma.
Dr. David Weiner from Wistar has signed a collaborative research agreement with Inovio. This lab is the heart of vaccine creation for Inovio although other partners contribute as well. Imagine the ability to support 100,000 vaccines within 8 weeks of an emerging outbreak or the ability to support the US military within weeks of an infectious disease outbreak. Imagine the ability to cure HIV or to break thru cancer defenses in multiple ways to potentially provide a cure to cancer. This is what Wistar is working on for deployment in 2018. In 2018 advances include:
DNA monoclonal antibodies (dMabs trademark) from Wistar and Inovio have the potential to bring 17 or more therapeutic, fast and potent immune response solutions to clinical trials per slide 36 of the Inovio Investor Presentation.
dMabs have the potential of addressing DARPA P3 goals of cutting response time to weeks and staying within the window of relevance for containing an infectious disease outbreak which can be used to support US military deployments.
dMabs have the potential of addressing CEPI Call for Proposal #2 which targets a 16 week timeframe from identification of antigen and a 6 week timeframe from administration of first dose to achievement of clinical benefit, and ability to produce 100,000 vaccine doses within 8 weeks to impact an emerging outbreak. Additionally, the Call for Proposals requests support for Lassa, Ebola, MERS, Zika, and Chikungunya. All 5 of these items are addressed by Inovio in dMab form per here, here, here, here, and here. If you read those latter links the results are quite impressive.
dMabs are also likely for 2018 in cancer, influenza, RSV, and even in antibiotic resistance
In early 2018 we can expect to hear more on Inovio’s clinical results from its Pennvax-GP vaccine for HIV which completed November, 2017 with 94 patients. Inovio and Wistar are committed to curing HIV. Inovio so far has demonstrated with nearly 100% success the highest overall levels of immune response rates in humans in any human study in 2017. Over 15% (9 of 29) “BEAT HIV” faculty come from Wistar including Dr. David Weiner himself. Wistar has nearly $23 million in funding for HIV. Note that this grant is for an HIV dMab similar to those discussed above. Equally important is the ability to test HIV solutions as they are created and to that end Inovio test partners are also receiving money. There is a potential of HIV being fast tracked in 2018.
In 2017 Wistar and Inovio announced some exciting cancer solutions including WT1 which can break tolerance and targeting FAP which helps fight the tumor microenvironment. When these are combined with a universal cancer therapy (hTert) and an immune activator (IL-12) and further combined with a checkpoint inhibitor such as PD-1 there are some exciting things to look for in 2018 for helping to cure cancer.
For those questioning whether these vaccines will work, please watch this video particularly at the 10 minute 35 second mark. This is the principal investigator of Inovio’s flagship product (who does not work for Inovio) discussing with emotion how well Inovio’s vaccines can work with “every reason to think that we can tweak the system to get cure rates even higher”. Wistar has been tweaking for the past 2 years for greater success which makes 2018 and beyond even more promising.
Walter Reed and the US Army have partnered with Inovio over the past several years. More recently the partnership has been with testing of MERS. In the recent past Connie Schmaljohn from USAMRID and Inovio have partnered on electroporation for Army needs including a multi-head intradermal electroporation device to provide spatial separation to reduce interference of multiple vaccines provided to a patient simultaneously as might be required for troops being prepared for overseas deployment. And also recently Inovio and the Army are working together on a Lassa vaccine. And this Inovio paper, while the Army is not mentioned, is specifically setup to be aligned with the defense of the US military for the use of preventing a clostridium botulinum neurotoxin attack. Critical Limb Ischemia (NYSE:CLI) is also of importance to the Army and Inovio has been involved with that as well. The relationship of Inovio with the Army dates back over 10 years. Examples include a 2013 collaboration with Connie Schmaljohn from the Army for $3.5 million, a 2008 collaboration for bio-defense, and a 2006 $1.1 million collaboration. Historical collaborations give a clue as to how the future relationships with the company will go. One could expect that the past Army interest in intradermal electroporation will have an Inovio 2018 bioject intradermal device looking desirable to the Army. One may speculate that the Army would be interested in an order of bioject intradermal devices (potentially a multi-headed device for simultaneous injections which are spatially separated) in either 2018 or 2019.
Inovio has a significant ownership of partner Geneone Life Sciences in South Korea now that VGX in Woodlands, Texas (which Dr. Weiner and Dr. Joseph Kim cofounded) became a subsidiary of Geneone. Over 2018 Geneone will play a role in advancing Inovio partner vaccines to regulatory approval paths including Ebola, MERS, and Zika. Geneone will also play a likely role in advancing several dMabs particularly in the cancer space (anti-HER2 and herceptin per here and here).
Grants received can offset cash burn rate for Inovio in 2018. Examples of grants include:
Gates Foundation $6.1 million sub-grant through Wistar for Zika
IVI and Samsung Foundation grant of “part of” $34 million for MERS
Three separate grants of $6.95 million, $25 million, and $16 million are awarded from NIAID to Inovio and collaborators for HIV. The $6.95 million grant is for a two-step clinical study in HIV positive subjects to assess Inovio’s HIV immunotherapy PENNVAX-GP with INO-9012 (an IL-12 immune activator).
Inovio is in the ending phase of wrapping up a $45 million DARPA grant from 2015 with likely further interest from DARPA P3 program as mentioned in this article
Inovio has smaller ongoing grants from the US Army for advancing delivery of DNA vaccines. For example, in 2016 it received a grant for $500,000 which is an ongoing series of small grants from the Army dating back more than a decade.
Other partnerships exist that could impact 2018 for Inovio. Please reference the Supplemental Information to this article for details.
Inovio Investment Proposition
As with any investment there are risks involved. Please do your own due diligence and be aware that shares can lose value as well as gain value. As of the time of this writing Inovio is trading near its 52 week low ($4.13 per share currently versus $4.09 at the 52 week low point). Factors involved with trading low include a recent dilution to raise cash.
Inovio’s cash position is over $100 million compared to a market cap near $373 million with no debt which is a favorable cash to market cap ratio. The Medimmune partnership alone has a potential value worth roughly twice Inovio’s current market cap not accounting for any other partnerships mentioned in this article. Many of the other partnerships mentioned also have potential to be multiples of Inovio’s current market cap. A potential spinoff of Geneos Therapeutics can also represent multiples of the current market cap of the stock. Also the patent portfolio owned by Inovio is quite large with over 100 patents protecting Inovio intellectual property. An investor might factor in the value of that patent portfolio in addition to Inovio’s cash position when considering an investment in the company.
Cash burn rate was high over the 3rd quarter of 2017. However, we present in this article multiple events that have the potential to occur in 2018 to offset the burn rate and even has the potential of being a profitable 2018 if events are favorable. Contributing to cash burn rate is higher employee count at over 270 employees but at the same time those employees are contributing to the growth model to address the opportunities presented in this article. Also contributing to cash burn rate is larger office space but at the same time that office space represents an opportunity for device shipments to customers and manufacturing ramp up to be ready for shipments of product which is required of late stage biotechs. Last, contributing to cash burn is a larger pipeline including a phase 3 trial but on the flip side a bullish argument could be made that the larger pipeline is leading to greater opportunities for Inovio to provide solutions to market and to potentially partner with others.
Summary
Frequent published analyst articles focus on short term technical volume and price based indicators. This review focuses on pipeline, industry partnership, and fundamental issues that are believed by the author to be stronger indications of the future direction of the company.
We have presented dozens of vaccine targets that are on the short term radar for Inovio. We have listed multiple partnerships and associations which will drive Inovio growth forward in the coming years starting in 2018. We have examined the potential for 6 products to be released by partner Plumbline Life Sciences ahead of VGX-3100 (Inovio’s cervical dysplasia product) going commercial including a few products with potential commercial viability in 2018. We have examined 3 likely candidates for EUA approvals for either stockpile orders or field use authorizations for Inovio products ahead of VGX-3100 going commercial in 2020. We have examined internal growth within the company and by its partners. And we have documented both US government (DARPA/Walter Reed/Army) and international (CEPI/IVI/other) interest in Inovio progress. We have discussed the potential of 6 priority review vouchers (PRV’s) which may be obtained by Inovio starting in 2018 each of which may be worth up to the current approximate market cap of Inovio. The future looks bright for Inovio. And if the indications of this article hold true the future brightens significantly starting in 2018.
Again, the reader is encouraged to visit the Supplemental Information link for this article.
Stocks: INO
Disclosure: I am/we are long INO.
Additional disclosure: The author was not paid or compensated for the views in this article.
______________________________________
https://seekingalpha.com/instablog/47724076-douglas-mcbride/5092974-inovio-poised-breakthroughs-2018-beyond
INO
3 Promising Cancer Immunotherapies to Watch in 2018
Keith Speights, The Motley Fool
December 22, 2017
Any way you look at it, immunotherapies -- also known as immuno-oncology (I-O) drugs -- are hot commodities. Two of the top three cancer drugs projected to be the biggest winners in the next five years are immunotherapies: Bristol-Myers Squibb's (NYSE: BMY) Opdivo and Merck's (NYSE: MRK) Keytruda. Together, those two combined are on track to generate revenue topping $8 billion this year.
Immunotherapies work by spurring the body's immune system to fight cancer. The approach has gained such incredible traction in the research community that there are now over 2,000 immunotherapies in clinical-stage development or on the market. Out of that vast number, I think there are three especially promising cancer immunotherapies to watch in 2018.
Epacadostat
Incyte (NASDAQ: INCY) could have the most eagerly anticipated immunotherapy on its hands with epacadostat. Some types of cancer cells produce a protein called IDO (indoleamine 2,3-dioxygenase). This protein shuts down immune system T cells, which would normally attack the tumor. Epacadostat works by inhibiting production of IDO, therefore allowing the body's immune system to fight back against cancer.
Epacadostat's potential is so great that several major drugmakers have teamed up with Incyte to test the drug in combination with their own immunotherapies. Bristol-Myers Squibb and Incyte are evaluating a combination of Opdivo and epacadostat in late-stage studies targeting non-small cell lung cancer (NSCLC) and head and neck cancer. AstraZeneca and Incyte are also working together in testing a combination of Imfinzi and epacadostat in treating NSCLC.
But the most important study to watch next year is the late-stage Echo-301 study that Merck and Incyte are conducting to evaluate the potential of a Keytruda-epacadostat combo in treating melanoma. The two companies expect to announce results from this study in the first half of 2018. Echo-301 will be the first late-stage study to wrap up for epacadostat. If the results are positive, it could bode well for the many other combination studies that are in progress.
___________________
https://finance.yahoo.com/news/3-promising-cancer-immunotherapies-watch-110400872.html
INCY
Out @ $7.14 for now, my pre-determined sale price. $7.15 seems to be the new resistance (although has great volume)
13-Week High 7.73
Pivot Point 2nd Level Resistance 7.26
High 7.17 High
1-Month High 7.17
Last Price 7.09 Last Price
Pivot Point 1st Resistance Point 7.07
7.06 3-10 Day MACD Oscillator Stalls
6.92 38.2% Retracement From 13 Week High
Previous Close 6.88 Previous Close
https://www.barchart.com/stocks/quotes/CLF/cheat-sheet
Over-sold on Wm%R(14) and CCI(20)
CLF
Thanks, makes sense given CLF's recent actions.
CLF
Your post triggered a recollection about CLF and the community. Do you know if these concerns have been put to rest in the intervening years? I'd assume that the new administration's environment stance has come into play.
__________________________________________________________
Northshore Mining and environmentalists square off over proposed taconite-pit expansion
By Stephanie Hemphill | 10/31/14
Cliffs Natural Resources
Northshore Mining wants to expand its Peter Mitchell Mine near Babbitt into an area that contains sulfur-bearing rock.
DULUTH — Even as environmentalists in northern Minnesota fight to stop a copper mine because it could send sulfuric acid into the region’s lakes, a proposed iron-mine expansion is drawing concern over the possibility that it could have a similar effect. Northshore Mining, based in Silver Bay, plans to expand its taconite pit south of Babbitt into an area that contains sulfur-bearing rock.
When sulfur in the soil is exposed to water, the runoff can damage streams and lakes. In extreme cases, acid mine drainage can kill everything in a body of water. Northshore owner Cliffs Natural Resources says it can stockpile the sulfur-laden rock to minimize contact with water. But environmental groups are calling on the state to conduct a more detailed study before allowing the expansion.
“This is 2014; we should know better,” said Paula Maccabee, attorney for Water Legacy. “Mining in high sulfur rock requires careful examination of scientific information, conservative assumptions, examination of alternatives to minimize harm, and caution in determining effects on both surface and groundwater,” she said.
The Minnesota Department of Natural Resources has prepared a preliminary review, called an Environmental Assessment Worksheet. Environmental groups are asking the agency to conduct a much more detailed analysis, called an Environmental Impact Statement.
Cliffs declined an interview for this story, but issued a statement and answered questions by e-mail.
“Northshore Mining has worked with the Department of Natural Resources and Minnesota Pollution Control Agency over 10 years to develop the current mitigation plan for mining this area of the operation’s reserve,” the company said. “If Northshore does not mine this area, it would reduce the life of the mine, thereby limiting the positive long-term employment and economic benefits of the operation for the surrounding communities.”
This is the first time the state has required environmental review before allowing a taconite company to expose rock with sulfur content. Earlier exposures at the nearby Erie/LTV mine in the 1970s and 1990s resulted in acid mine drainage affecting the Dunka River. It flows between the LTV mine pit and Northshore's Peter Mitchell Mine pit into Birch Lake, a 7,000-acre lake between Ely and Babbitt, popular with anglers for walleye and northerns.
From Birch Lake the water flows into the South Kawishiwi River, through the Boundary Waters Canoe Area Wilderness (BWCA) and ultimately into the Rainy River and north to Hudson Bay. Water from the waste pile of this sulfide rock has been leaching acidic and toxic runoff ever since. LTV closed in 2000; Cliffs Natural Resources bought the property and is now responsible for cleanup. The company has spent years experimenting with constructed wetlands designed to purify the water, but sulfur and other pollutants running into the Dunka River continue to exceed limits in state statutes.
A new and mammoth rock pile
In a 108-acre area on the edge of its 12-mile-long Peter Mitchell Mine pit just south of Babbitt, Cliffs plans to dig away nearly 10 million tons of surface material and bedrock each year to get at the taconite below. As mining progresses over the course of seven to 10 years, workers will build a pile of waste rock in the pit. The sulfur-laden rock will be placed on top of 5 feet of crushed rock that doesn’t contain sulfur, to minimize contact with groundwater and storm water. As it is built, the pile will be covered with a liner designed to minimize water infiltration, which in turn will be topped with soil seeded with grass. Cliffs says it will cover the pile progressively before each section is likely to start producing acid. The completed pile is expected to cover 153 acres.
Water running off the pile will be directed to the Dunka River, joining runoff from the old LTV stockpile, and flowing into Birch Lake.
Minnesota Department of Natural Resources
The current mine limits are outlined in green. The proposed expansion area is outlined in red. The yellow outline represents the proposed location for storing sulfurous rock.
Perhaps the most astonishing thing about the Northshore mine is that when it closes, it will change the watershed divide in the area. The mine pit straddles the divide between the Lake Superior Basin (through the St. Louis River) and the Rainy River Basin (through the Dunka River). The land separating the two basins was blasted away, and as long as the mine is in operation, pumps direct water to both basins. But when the mine closes and Cliffs Natural Resources allows the pit to fill, all the water draining from the pit will go to the Rainy River Basin.
While Cliffs says the design of its new stockpile will minimize acid runoff, environmentalists aren’t so sure.
Specific criticisms
Kathryn Hoffman, an attorney with the Minnesota Center for Environmental Advocacy, said PolyMet Mining, which has proposed NorthMet, a copper-nickel mine that would be a near neighbor to the south of the Peter Mitchell pit, has gone into much more depth with studying how stockpiles could be designed.
“They looked at placing liners under the stockpile as well as over it,” she said. “They developed strategies for collecting water from the stockpile. To me there’s not a good reason why the Northshore mine shouldn’t be looking at those strategies as well.”
She also said Northshore’s plan doesn’t do enough to deal with heavy metals. “Much of the risk from acidity comes from the leaching of heavy metals,” she said.
The environmental worksheet says cobalt in effluent could increase by 140 percent, copper by 50 percent, and nickel by 268 percent compared to recent water-quality measurements. Yet the DNR’s worksheet says “modeling predicts that the water concentrations will likely be below applicable standards.”
Northshore’s permit expired in July, but the Minnesota Pollution Control Agency is not in a hurry to renew it. (It’s common for industries to continue to operate under expired permits, as long as they are meeting the permit’s requirements.) The agency is working on other permits identified as higher priorities, under pressure from the federal Environmental Protection Agency. The mine’s expired permit does not include limits on cobalt, nickel, copper and other metals; it merely requires the company to monitor for them.
“I don’t think the DNR is holding companies to a standard they should,” Hoffman said. “Conducting an Environmental Impact Statement would bring more agency expertise to bear.”
Potential impact on wild rice
Water Legacy’s Paula Maccabee said there are many reasons more analysis is needed, but a big one has to do with an issue much in the news lately – the potential impact of sulfate on wild rice. The environmental worksheet predicts increased sulfate content in the mine’s effluent – up to 15 times the state limit for wild-rice waters. The worksheet says the wild-rice standard does not apply in this case, but other DNR documents list Birch Lake as a wild rice lake.
Maccabee also said experiments designed to predict how acidic the runoff will be did not include samples from all parts of the proposed expansion area, making the prediction unreliable. And she suggested the huge pit lake that will be created when the mine closes is liable to put pressure on underlying faults and fractures in the bedrock, creating the potential for polluted water to seep into groundwater systems, including drinking water supplies.
Critics are also concerned about the rock face that will remain exposed after the ore is removed. The vertical wall of sulfur-bearing rock will run more than a mile and a half long and 55 feet high above the eventual water level. Rain falling on the rock will likely form some amount of sulfuric acid. In a statement, Cliffs Natural Resources said its studies “indicate that the relatively small exposure area of the pit wall has insignificant contributions to the pit water chemistry.”
Analysis sought of effects in wider context and over time
Environmental groups want the DNR to conduct a thorough analysis of the potential cumulative effects of the project, considering other taconite mines in the area and the proposed PolyMet and planned Twin Metals mines.
“We need an Environmental Impact Statement to look at impacts on surface water and make sure we’re not allowing high-sulfur water to get into our precious groundwater aquifers,” said Maccabee.
The DNR declined to discuss technical questions about the environmental worksheet. Spokesman Chris Niskanen said the agency has received more than 600 comments, and staffers need to “take a hard look at them and have some pretty intense internal discussion about the technical aspects of the report” before talking to the media. The DNR has until early December to decide whether to do a more detailed study.
_____________________________________________
https://www.minnpost.com/environment/2014/10/northshore-mining-and-environmentalists-square-over-proposed-taconite-pit-expans
CLF
Maybe the shorts will be squeezed today. Very volatile the last half hour as options expire.
CLF
Yep, a good number:
Cliffs Natural Resources Incorporated
$ 6.45
CLF
-0.10
Short Squeeze Ranking™
view
Daily Short Sale Volume
view
Daily Naked Short Selling List
view
Short Interest (Shares Short)
41,155,300
Short Interest Ratio (Days To Cover)
5.0
Short Percent of Float
17.75 %
Short % Increase / Decrease
-6 %
Short Interest (Shares Short) - Prior
43,840,500
Shares Float
231,808,500
Trading Volume - Today
3,146,545
Trading Volume - Average
8,280,300
Trading Volume - Today vs. Average
38.00%
% Owned by Insiders
11.38%
% Owned by Institutions
63.10%
Earnings Per Share
-48
PE Ratio
Market Cap.
$ 1,911,457,500
% From 52-Wk High
-51.82%
% From 52-Wk Low
% From 200-Day MA
-14.58%
% From 50-Day MA
-15.99%
Sector
Basic Materials
Industry
Steel & Iron
Exchange
NY
Record Date
2017-DecA
Mission Statement
The mission of ShortSqueeze.com TM is to provide short interest stock market data and services, so our members will be better informed of short selling in the market, track shorts in stocks and gain from the advantages that can be achieved from this valuable market data.
____________________________________________
http://shortsqueeze.com/?symbol=clf&submit=Short+Quote%E2%84%A2
CLF
Know the feeling! Don't despair, CLF just turned a bit perky in the past 5 minutes. A green finish today wouldn't be bad.
CLF
Still bid sitting, FWIW:
THC, HCA… 11:19 Battleground: JPMorgan says sell, Citi says buy Tenet Shares of Tenet Healthcare (THC) are sliding after JPMorgan analyst Gary Taylor downgraded the stock to Underweight, a sell-equivalent rating, citing his expectations for a negative impact from tax reform, its high relative balance sheet leverage and structural challenges for the hospital sector. This comes a day after his peer at Citi upgraded Tenet to Buy on a more constructive view of the industry and expectation of some "bounce" in patient volumes. SELL TENET: In a research note to investors this morning, JPMorgan's Taylor downgraded Tenet Healthcare to Underweight from Neutral, with an unchanged price target of $15. The analyst argued that he expects the company to underperform his coverage universe in 2018 due to key factors such as a negative impact from corporate tax reform, high relative leverage, structural challenges for the hospital sector and Tenet's long-term track record of poor free cash flow generation. The interest expense deduction limits in both the House and Senate bills would more than offset the decline in corporate tax rate for Tenet, he contended. BUY TENET: Yesterday, Citi analyst Ralph Giacobbe upgraded Tenet, alongside HCA Healthcare (HCA) and Universal Health (UNH), to Buy as he takes a more constructive view of the hospital space and expects some "bounce" in patient volume in 2018. While acknowledging the existence of structural pressures, he argued that a better volume backdrop in 2018 coupled with lower buyside expectations, depressed sentiment, discounted valuation, and favorable "external" factors - like tax reform and a lower Amazon (AMZN) risk than other sectors - sets up an attractive upside scenario. Further, the analyst told investors he is hopeful Tenet's divestiture plans and cost savings initiative are additional levers that should support and help improve its EBITDA. PRICE ACTION: In late morning, shares of Tenet have dropped over 3% to $14.31.
Read more at:
https://thefly.com/landingPageNews.php?id=2655427
THC
Time wise it is after, but not sure of the explanation. The most reasonable I see is this:
____________________________________________________________
Higher ore demand fuels Mesabi Trust's financials
Dec 12, 2017 Updated 4 hrs ago
Revenues and net income climbed substantially for the quarter and fiscal year-to-date for Mesabi Trust, according to its third quarter report.
Revenue was $12.2 million for the quarter and $29.2 million for the year compared with $3.4 million and $6.0 million for the same 2016 periods.
North Shore Mining extracts the ore and pays a royalty to the Mesabi Trust. The primary reason for higher sales and profits was an industry rebound, with pellet production increasing by about 1.2 million tons in 2017 versus the nine-month period a year earlier.
The increase in total royalty income was due to the increase in shipments during the fiscal quarter ended Oct. 31, 2017, as compared with the fiscal quarter ended Oct. 31, 2016, Mesabi Trust said.
Mesabi’s trustees previously declared a distribution of 64 cents per unit payable on Nov. 20 to unitholders of record at the close of business on Oct. 30.
______________________________________________________
Ask DEW
CLF
Interesting that since Tuesday, MSB is up ~15% and CLF up ~1%:
https://finance.google.com/finance?q=msb&ei=uJIyWqHrOs2TmgGY9ZDwBw
Link may not resolve so need to put in both symbols.
CLF
Not going down much. Supposedly (Market Beat), J P Morgan Chase & Co has high impact.
THC
Funny thing was just looking at the chart after the downgrade. Was thinking $13.90 ($13.90 was a former resistance) as a bid. BarChart cheat sheet has $14.10 as the 2nd resistance -- "Pivot Point 2nd Support Point 14.10". Doubt it goes that low but I tend to be conservative about such things.
Aside from technicals, tax plan looms and not sure of impact.
Your thoughts?
THC
Out ALT @ $1.73 for approx $100 loss. Huge volume today so may shoot up, but too frustrating. Level II is of no use as MMs not showing the numbers of shares in a meaningful way. Can see why this earns 2.84 Beta score.
ALT
EDIT: It did!
Crazy MMs on this stock. For over half an hour EDGX was trying to sell 53,000 shares at $1.64 and then for about 15 min selling the same for $1.63 and then they totally disappear. Too much manipulation.
ALT
Sure not helping today:
_________________________________________________
Here's Why Inovio Pharmaceuticals Inc. Fell 21.3% in November
A flurry of research progress couldn't distract investors from a larger-than-expected loss.
Cory Renauer (TMFang4apples) Dec 12, 2017 at 2:35PM
What happened
Shares of Inovio Pharmaceuticals Inc. (NASDAQ:INO), a biopharmaceutical company developing vaccines, fell 21.3% in November according to data from S&P Global Market Intelligence. Despite reporting some important pipeline progress investors weren't pleased with the company's widening losses.
So what
Inovio Pharmaceuticals Inc.'s third-quarter loss grew 64% to $34.1 million from $20.8 million last year. Without product sales to smooth out the bumps, Inovio's top line is prone to exceptional lumpiness from one quarter to the next as it recognizes various one-time cash infusions from collaboration partners.
A downward trending graph drawn on a blackboard.
IMAGE SOURCE: GETTY IMAGES.
Although total operating expenses remained relatively stable, the wider than expected loss served as a reminder that this company's operating expenses could grow significantly as it advances 10 new drug candidates in clinical-stage development.
Now what
This June, Inovio finally began a long-awaited phase 3 trial with the most advanced vaccine candidate in its development pipeline, VGX-3100 for the treatment of cervical pre-cancer caused by human papillomavirus. Enrolling 198 patients across 100 study centers around the globe isn't going to be cheap.
The company lost $66.7 million during the first nine months of the year. With just $141.9 million in cash, cash equivalents, and short-term investments on its balance sheet at the end of September, I wouldn't be surprised if Inovio announces another value diluting secondary offering in 2018.
Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
___________________________________________
https://www.fool.com/investing/2017/12/12/heres-why-inovio-pharmaceuticals-inc-fell-213-in-n.aspx
INO
Sold NCR @ $32.50. Will buy again if/when it drops. Generally doesn't hold daily gains very well.
NCR
Bullish SA article may be powering the action:
Cleveland-Cliffs: Recent Debt Offerings Are Signs Of Growth
Dec. 12, 2017 10:30 AM ET| About: Cleveland-Cliffs, Inc. (CLF)
Vladimir Zernov
(5,319 followers)
Summary
I discuss the recent debt offerings and their pricing.
The conversion price of convertible senior notes seems low to me, but interest rates on both issues are ok.
Cliffs buys former Essar property, preparing for future growth.
As the majority of readers know well, Cleveland-Cliffs (CLF) has recently announced offerings of $400 million senior secured notes due 2024 and $275 million of convertible senior notes due 2025. Convertible notes received the most attention as they potentially mean dilution for common Cliffs’ shareholders. Not surprisingly, Cliffs’ shares got initially hit on the news. However, the stock started to rebound as the market digested the news and also as Cliffs’ shares attracted buyers at the very strong support level in the whereabouts of $6.
(click link below for info
First, let’s start with the convertible notes due 2025. These notes received an interest rate of 1.50% and the conversion price of $8.17 per share. In my opinion, the conversion price is low and guarantees dilution in the future. Should underwriters exercise their over-allotment option in full, current Cliffs shareholders will be diluted by 13%. However, I do not expect that holders of convertible bonds will convert them into equity immediately after the price exceeds $8.17 per share, so any dilution is likely postponed to 2019 and beyond. Therefore, I see no reason to change my earnings expectations for the next year. Neither does the Street: analysts have kept next year's earnings estimates flat for quite some time:
(click link below for info
Source: Yahoo Finance
The $400 million of senior secured notes due 2024 received an interest rate of 4.875%. This is a major improvement compared to the company’s previous offerings, which is reflecting Cliffs’ increased financial strength. Back in summer, Cliffs offered $575 million of senior guaranteed notes which received an interest rate of 5.75%. After the two offerings, Cliffs’ debt will look like this:
(click link below for info
Some investors will argue that increasing debt is not a good thing to do. However, Cliffs is transitioning for a company battling for survival into a growth-focused company and some leverage is unavoidable. Importantly, the company won’t have big debt maturities until late 2024, so it will have almost 7 years to improve its position.
Cliffs has previously stated that it intended to use the proceeds from the offerings to finance a substantial portion of its hot briquetted iron (HBI) capital project. However, the recent news show that there may be more things in play. The company has just stated that it completed an acquisition of certain real estate interests in Itasca County in Minnesota, which were previously leased by Essar Steel Minnesota. Cliffs’ CEO, Lourenco Goncalves, commented: “We are enthused about the acquisition of this property, which came into play after Chippewa failed to follow through on its obligation to obtain financing and a bankruptcy exit for Mesabi Metallics by October 31. Despite several botched attempts by others, it is now the time for Cleveland-Cliffs to sit at the table with other responsible parties and develop a realistic solution for this site”.
Some time will pass before the market starts valuing Cliffs as a growth company rather than an iron ore miner in battle for survival. However, the trend of the business is to the upside and the stock will ultimately follow. The support that Cliffs’ shares received after the offerings’ news confirm once again that the bottom was previously set at $5.60. Should stock fall lower than $5.60 for whatever reason, I’d consider the bullish thesis busted. Should the bullish scenario continue to slowly develop, the conversion price of $8.17 will serve as the first important upside target.
If you like my work, don't forget to click on the big orange "Follow" button at the top of the screen.
Disclosure: I am/we are long CLF.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
____________________________________________
https://seekingalpha.com/article/4131309-cleveland-cliffs-recent-debt-offerings-signs-growth
CLF
Just checked the mail box, by now I'm sure you saw it was raised to a buy by Citigroup. Mad at myself because I'm out. Had a bid that was too low last Friday, so missed out yesterday and today. I'll wait on the sidelines.
Good company -- just like to buy low.
You're doing well. Congrats.
THC
It sure looks possible. Great run beginning at the first of November. Unfortunately I have no shares and been out for a while. Been following occasionally, but kept waiting for the dip which hasn't appeared.
Good luck, you've done great.
HIVE
Altimmune Submits Investigational New Drug Application for NasoShield in Preparation for its Phase 1 Trial
By GlobeNewswire, December 11, 2017, 08:00:00 AM EDT
145 Patients to be enrolled
Data expected in the second quarter of 2018
Study will be fully-funded by BARDA
GAITHERSBURG, Md., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NasoShield, the Company's next generation anthrax vaccine. In animal models, a single dose of NasoShield induces rapid and durable antibody responses and protects against lethal challenge likely in half the time as the current FDA approved anthrax vaccine, which requires multiple doses.
"We are excited to continue to move the NasoShield program forward with this IND filing and look forward to starting the initial human clinical trial in early 2018," said Dr. Sybil Tasker, Chief Medical Officer at Altimmune. "In the setting of a bioterrorism event or natural exposure, a single dose, needle-free vaccine would avoid taxing health care resources and represents a great improvement over current standard of care. We are proud to help the government improve responsiveness to public health threats and look forward to achieving the milestones of this important project."
This Phase 1 study will assess the safety and immunogenicity of a single intranasal dose of NasoShield at four dose cohort levels. One additional cohort will receive a repeated dose at Day 21. The study is expected to enroll 145 patients who will receive either NasoShield, three doses of the currently licensed anthrax vaccine, or placebo. Data on the single dose cohorts are expected sometime in the second quarter of 2018.
The NasoShield program is funded through a contract currently valued at $21.6 million with options, that if fully exercised, has a value of $127 million (HHSO100201600008C) with the Biomedical Advanced Research and Development Authority (BARDA), which runs through September 2021, and, if all options are exercised, will provide funding through the end of Phase 2 development.
About Altimmune
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease including NasoVAX, a Phase 2 seasonal influenza vaccine candidate, and HepTcell, a Phase 1 immunotherapeutic candidate for the potential cure of chronic hepatitis B. The company also has two next-generation anthrax vaccine candidates that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines.
Forward-Looking Statement
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. (the "Company") may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company's BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Form 10-K filed March 14, 2017, Form 10-Q filed August 14, 2017 and in the Form 8-K filed August 17, 2017, which are available at www.sec.gov.
Altimmune Contacts
Bill Enright
President and CEO
Phone: 240-654-1450
Email: enright@altimmune.com
Ashley Robinson
LifeSci Advisors, LLC
617-775-5956
arr@lifesciadvisors.com
________________________________________
http://www.nasdaq.com/press-release/altimmune-submits-investigational-new-drug-application-for-nasoshield-in-preparation-for-its-phase-20171211-00403
ALT
Hope so, painful to watch closely. Same pattern as yesterday. MMs were selling on the bid all day long. Even the last batch of trades were continuous selling on bid at the low of the day. Last trade, a buy at ask of $1.74 saved the day from disaster.
ALT
Metals stocks move up as China’s commodity demand picks up
Dec. 8, 2017 8:30 AM ET|By: Carl Surran, SA News Editor
Metals stocks are mostly higher after China reported exports surged 12.3% in November from a year ago, more than double expectations, and imports climbed 17.7%; X +1.5%, VALE +1.3%, BHP +1.2%, CLF +0.9%, FCX +0.8%, RIO flat in premarket trade.
China’s demand for commodities jumped, as the world’s largest consumer of raw materials saw higher imports of copper, crude oil and iron ore; shipments of copper soared 42%, iron ore jumped 19%, and imports of crude oil hit 9.04M bbl/day, their second highest recorded level ever.
Traders say the import data should help support commodity prices, which have been hit by concerns about slowing economic growth in China.
Jefferies analysts say sharp declines in Chinese finished steel exports show improved supply-side discipline while low inventories and strong prices and margins further highlight market tightness; the firm says ArcelorMittal (NYSE:MT) is its sector favorite.
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https://seekingalpha.com/news/3317201-metals-stocks-move-china-s-commodity-demand-picks?app=1&uprof=46#email_link
CLF
Big short volume:
http://shortvolumes.com/?t=alt
Watched the Level II throughout much of the day yesterday and MMs were selling on the bid throughout the day. Good size spread and the trades were almost always at bid or close to it, rarely at or near the ask. The pattern didn't change until the last 10 minutes when they moved to the ask.
Been picking up more lower price shares, but don't want to keep on buying forever.
ALT
Your thoughts are with those of others as noted in the SA blog which I just posted. Guess the impact if any is mainly on the steel makers.
CLF
U.S. Steel, AK Steel surge on tariff ruling; Axiom's Johnson pooh-poohs news
Dec. 6, 2017 11:39 AM ET|About: AK Steel Holding Corp (AKS)|By: Carl Surran, SA News Editor
Steel names including U.S. Steel (X +6.4%) and AK Steel (AKS +5.5%) enjoy hefty gains following the Commerce Department's move to impose import duties on steel from Vietnam that originated in China.
While the market is rewarding the shares today, Axiom Capital's Gordon Johnson maintains the DoC's decision is "virtually irrelevant in terms of supply/demand."
Johnson says imports of cold rolled coil and hot-dip galvanizing steel have "virtually collapsed" since November of last year.
Vietnam suppliers say their product does not include Chinese components, and U.S. importers have continued to buy their steel, meaning that Johnson expects about half of the current imported Vietnamese steel gets banned incrementally.
Also: NUE +1.2%, STLD +1.3%, CMC +2.4%, MT +1.9%, CLF +1.3%, WOR +0.4%, RS +0.8%, SLX +0.8%.
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https://seekingalpha.com/news/3316678-u-s-steel-ak-steel-surge-tariff-ruling-axioms-johnson-pooh-poohs-news?app=1&uprof=46#email_link
CLF
I guess we're too distant from this (thought would have some impact):
US slaps Vietnam sheet with triple-digit duties
Dec 05, 2017 | 06:11 PM | Michael Cowden
Tags Commerce Department, circumvention case, cold-rolled steel, coated steel, Vietnam steel, China steel, flat-rolled steel, steel imports Michael Cowden
CHICAGO — Vietnamese cold-rolled and coated flat-rolled steel made from Chinese substrate is circumventing US duties, the Commerce Department said in a preliminary determination on Tuesday December 5, with cash deposits set as high as 522.23%.
The duties will apply to all shipments that entered the US since November 4, 2016, the date the circumvention petitions were initiated.
US Customs and Border Protection will collect anti-dumping duties of 199.43% and countervailing duties of 39.05% on coated material, with those for cold-rolled at 265.79% and 256.44% respectively - the same duties applied to Chinese product.
Importers of cold-rolled and coated made from Vietnamese steel or that from third-party countries can seek an exemption from potentially massive cash deposits if they can certify that the substrate didn't come from China, Commerce said.
The agency plans to announce its final determination on February 16, 2018.
Preliminary decisions in the Vietnam circumvention cases have had multiple delays. Commerce last month cited their complexity, which could result in a precedent-setting change to the definition of "substantial transformation."
Michael Cowden
mcowden@amm.com
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http://www.amm.com/Article/3772897/Steel/US-slaps-Vietnam-sheet-with-triple-digit-duties.html
CLF