Outlook possibility_ With the announcement of a $1.0 M contract current but also new investors will better understand NLNK's diversification strategy and therefore risk aversion. With NLNK's current portfolio, the soon (within 6 months) to be expected second interim data of their ongoing IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 clinical trial, a stock price off more than 50% from the high from February 2014 ($53.48), and an obvious support in the $19/20 area, NLNK is a clear buy.
A 7 week streak catapulted NLNK from $21 to over $50 earlier this year in anticipation of the first interim look at their IMPRESS trial.
o I expect a similar run-up to at least the $40 area (but new highs are also possible) during the next 3 months in anticipation of the Phase III clinical data announcement. By January 2015 (before the announcement) NLNK should trade in a $45 to $55 range which would leave still significant upside (considering the US market size of pancreatic cancer - $1.2B by 2015 based on ransparency Market Research , in addition to potential markets in Europe and Japan and follow up products already tested in clinical trials: melanoma and lung cancer and the IDO inhibitors) in case of an end of the Phase III study based on positive interim data at the second look. NLNK's vaccine candidate is not only an impressive vaccine proven safe PLoS Negl. Trop.Dis 2012;6:e1567 and efficacious in more than hundred non-human primate studies (including immuno-compromised animals - PloS Pathog 4(11): e1000225 , , but is also currently one of the few post-exposure treatments available to combat the disease ( J infect Dis. 2011: 204 suppl 3:S1075-81. Considering the rapid onset and devastating symptoms of the disease in case of filovirus infections it is a miracle to save someone from a disease with average case fatality rates of 70 to 90% (basically the majority dies once infected with the virus).
Its time to ask shorts if doubling revenue is good with 17% margins and profitability coming?
- 8-15-2014- Management highlighted a back end loaded year as Wal-Mart Stores ramps up their deployments at several sites coupled with deployments at Kroger and other key customers. In addition, while year to date bookings stand at $87 million, management reiterated their aim of $150 million for the year and noted that one deal could be as high as $30 million The company shipped 687 units during the second quarter of 2014 compared to 246 units in the second quarter of 2013. Plug Power Inc. Plug has customers including Walmart, Procter & Gamble , and Central Grocers. GenDrive, an alternative energy supply, is a substitute for lead-acid batteries for uses such as in forklifts for Walmart and was a key reason for the growth.
Margins and Company Commentary
The company reported a gross margin of 17% on its GenDrive product for the second quarter. They Expect product gross margin to reach mid-20 pct in Q4 Plug Power also successfully deployed another product, GenKey, at the Walmart distribution center in Pottsville, PA and as a result, Walmart added an additional site in Sterling, IL to the original six-site contract.
The North American fuel-cell maker to turn a net profit as it recorded a gain on stock warrants.
The company, which deployed its first hydrogen fuel cell unit at a Wal-Mart site in the second quarter, reported a 17 percent gross margin in its product business. The Latham, New York-based company shipped 687 fuel-cell units in the quarter ended June 30, higher than the 650 it had forecast earlier. Plug Power's second-quarter revenue rose 131 percent to $17.32 million. Analysts on average had expected $16.7 million, according to Thomson Reuters I/B/E/S.
Net income was $3.8 million, or 2 cents per share, in the second quarter, compared with a net loss of $9.3 million, or 14 cents per share, a year earlier.
Automakers have been among the fastest adopters, with Volkswagen ( ), BMW, Mercedes-Benz and Honda Motor buying Plug Power systems for use in their factories.
Plug Power said it expects, “a plethora of global opportunities” from the auto-manufacturing market such as Daimler AG and BMW AG to use fuel cells to power forklifts and other material handling devices in their warehouses. The company said it had new orders from car makers such as Volkswagen and BMW, Honda Motors, a new customer and range extenders to FedEx Inc. electric trucks.. This could be a ROCKET, HYGS went straight up from 5 to 30 in two years… 2013 and 2014 are turn around years. They will merge from a “Developmental” company, To morph into a HYDRO conglomerate. Fuel cells are going to be an important energy source for a number of applications and the long-term future is certainly bright - with a bonus of being around 50 percent off of its 52-week high of $11.72 a share. ** Plug Power, with about 150 patents in fuel cells, is expecting growth and intellectual value. GE is now entering the field and other will look to PLUG and other to catch up. Other will follow and look to those who have the expertise and Partner or buy ** We expect management to highlight continued sequential growth through the year. Of note, we were pleased to see the company turn gross margin positive during the quarter and we anticipate continued leverage in the model and further cost reductions to be highlighted by management. ***Huge corporations like Walmart, Bridgestone , Mercedes have tested Hydro batteries and its just a matter of time before Hydro stations are built. Countries like Japan are noe offering HUGE incentives to good with fuel cells. Others will follow, Japan's 25-year plan will cause the country to import fuel cells, which will create an opportunity for fuel cell manufacturers.
This is the one Ebola stock people should have. Its the one in the press and will make more news. We should be getting more reports of how those health care workers got sick. Its either air borne, mosquitoes or carried by birds . Some thing is just not right when that many get sick with precautions.
who said TKMR was a pump and dump. It dig go up to 26 and come back down but to many it is a long term hold. Analyst still have a 26 target and that was on it before the Ebola scare. The HEP B results are due soon. I just went by their building a little bit ago and checked them out. If you did any research you will find some air transfer Ebola among pigs and a controlled setting. None documented out side the lab. NLNK is in the Iowa state research LOOP. If you know any thing about Iowa state and Ames they have the National Disease labs also. When you are the first to go to Africa that said a lot. Its more then a PUMP- Results make you first.
100 are sick already. this is unprecedented we are not getting the whole story. .
I just saw it this morning and ran to the computer to buy. I got burned in TKMR and still hold SRPT.
NLNK is primed for jump. Marck 2014 high was 50 dollars and recent press could be a windfall. The stock has a twenty five per cent short position with insiders owning 32% and institutions 34%. Through its wholly owned subsidiary, BioProtection Systems Corporation (BPS), today announced a letter contract with the United States Defense Threat Reduction Agency (DTRA) for studies that will bring an Ebola vaccine licensed from the Public Health Agency of Canada closer to human clinical trials. The market cap 720 million and float of 19.84 million shares. "There is an urgent need for a medical countermeasure against the deadly Ebola virus," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "This Ebola vaccine has been 100% effective in preventing lethal infection when given to non-human primates before they are infected with the virus. 1) The first is our HyperAcute® immunotherapy technology, which is currently focused on enhancing vaccines for influenza but can be adapted to a number of vaccines. 2) The second technology is based on the yellow fever virus vaccine strain. 3) The third technology is a replication-competent recombinant vesicular stomatitis virus, or rVSV, an advanced vaccine technology developed for the Marburg and Ebola viruses. *** NewLink's HyperAcute immunotherapy platform creates novel biologic products that are designed to stimulate the human immune system to recognize and attack cancer cells. HyperAcute product candidates are composed of human cancer cells that are tumor specific, but not patient specific. These cells have been modified to express alpha-gal, a carbohydrate for which humans have pre-existing immunity. These alpha-gal-modified cells stimulate a rapid and powerful human immune response that trains the body's natural defenses to seek out and destroy cancer cells. *** NewLink's lead product candidate, algenpantucel-L (HyperAcute pancreas), is being studied in a Phase 3 trial (IMPRESS: "Immunotherapy for Pancreatic Resectable cancer Survival Study") under a Special Protocol Assessment with the U.S. Food and Drug Administration. This trial involves up to 722 patients with surgically resected pancreatic cancer. Algenpantucel-L is also being tested in a second Phase 3 study (PILLAR: "Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable"), involving patients with locally advanced pancreatic cancer. *** NewLink has several HyperAcute product candidates focused on other tumor types in various stages of development, including tergenpumatucel-L, which is in an adaptive design, randomized Phase 2B/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer. Ebola crisis- The warning came just a day the World Health Organization said the scale of the epidemic had been vastly underestimated and that "extraordinary measures" were needed to contain the killer disease. A Month away- The vaccine, called VSV-EBOV, was developed by Canada's National Microbiology Laboratory and is licensed by Ames, Iowa- NewLink is working "around the clock" to start trials, president Nicholas Vahanian said in a telephone interview. "I would personally not hesitate to take that vaccine," said Thomas Geisbert, a virologist at the University of Texas Medical Branch and a developer of the vaccine donated to WHO by the Canadian government. "I've seen it used in many, many non-human primates. Never saw a problem with it." Developing- NewLink also is negotiating with manufacturers to ramp up production, aiming for 10,000 doses within months, Wiley said in a phone interview. Deadly Outbreak
Health officials are weighing the risk of using unproven products as the disease has killed more than 1,000 people and teams of researchers rush to get their vaccines into clinical trials. The outbreak, the worst since the virus was first identified in 1976, has raged through Sierra Leone, Liberia and Guinea and recently reached Nigeria, Africa’s most populous nation. Modupeh Cole, a prominent Sierra Leone doctor treating Ebola patients, died after being infected, the government reported yesterday.
ROLL OUT_ Nancy Kass, a professor of bioethics and public health at the John Hopkins Berman Institute of Bioethics in Baltimore, is among those urging a gradual roll out for the Canadian vaccine
I held through the conference call and am about even on my investment. I bought a position here a few minutes ago. I saw a piece on the local news channel.
TV8 news said they are drastically underestimating the news. Deaths of 1000 and 2000 infected. People on the TKMR board were saying up to 100 health care workers are infected. How can that be with only bodily fluid transfers. (cant happen). Maybe a couple mistakes as they take the necessary precautions of full gowns. I believe it can be transferred other ways? Some thing is not right with the virus. I pray it don't mutate and change many viruses do.
25% short position is looking to get squeezed. Some people just get happy when the make money. Many longs could be very happy today. The stock was mentioned on TV8 news in Des Moines Iowa today.
This will validate the company’s technology and progress. Before Ebola, the play on this company was for it's hepatitis B results, which are due out soon enough. TKM-HBV is being developed as a multi-component RNAi therapeutic that targets multiple sites on the HBV genome. Because HBV is a viral infection of the liver, the TKM-HBV therapeutic will employ a liver-centric-LNP formulation that is more potent and has a broader therapeutic index than any LNP currently in clinical development. We anticipate completing the necessary preclinical work and expect to file an Investigational New Drug (IND) application in the second half of 2014. We plan to advance TKM-HBV into chronically infected HBV patients. 8 13 2014- __ The current outbreak underscores the critical need for an effective therapeutic agent to treat the Ebola virus,"said Dr. Mark J. Murray, Tekmira's President and CEO.__ "We remain sharply focused on our clinical programs and the key milestones to be reached by year end. Importantly, our Hepatitis B program continues to advance, with the goal of filing an IND, or equivalent, for our TKM-HBV program in the second half of 2014. _ _ TKM-PLK1 oncology platform, we expect to present Phase IIa interim data from our clinical trial with GI-NET and ACC patients before the end of this year, and we have begun enrollment in an additional Phase I/II trial targeting HCC patients," stated Dr. Murray._ __ For the second quarter ended June 30, 2014 we had cash, cash equivalents and investments of $129.5 million. The company has 22.1 million common shares issued and outstanding, and 24.6 million shares on a fully diluted basis.
• The single ascending dose portion of the TKM-Ebola Phase I clinical trial has been successfully completed in healthy human volunteers. As per the protocol maximum tolerated dose (MTD) was established to be 0.3 mg/kg for healthy subjects without steroid premedication.
• In July, we received notice from the U.S. Food & Drug Administration (FDA) that our TKM-Ebola program was on clinical hold. Subsequently, the company received written notice from the FDA modifying the clinical hold to a "partial clinical hold," allowing for the potential use of TKM-Ebola in individuals who have a confirmed or suspected Ebola infection. The company remains on clinical hold as it relates to the multiple-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola. The company expects this matter to be resolved by Q4 2014.
• Our therapeutic, TKM-Ebola, is currently an unapproved agent and the regulatory framework to support its use in Africa has not yet been established. Given the severity of the situation, we are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols. This includes discussions with government agencies and NGO's, including the WHO, in various countries on the potential use of TKM-Ebola to treat Ebola virus infected individuals. There can be no assurance that an appropriate framework for the use of this product will be found. We will continue to provide updates as necessary when clinical and regulatory pathways become confirmed.
• Within our TKM-PLK1 clinical trial targeting GI-NET and ACC patients, we saw an additional RECIST qualifying Partial Response (PR), defined as a greater than 30 percent reduction in target tumor lesions. This patient is continuing on therapy and has achieved a 44 percent reduction in their target tumor mass, located outside of the liver. Furthermore, scans of the target tumor lesions demonstrate signs of necrosis, indicative of anti-tumor activity.
• We have initiated a Phase I/II clinical study of TKM-PLK1 in patients with Hepatocellular Carcinoma (HCC).
• We intend to file an Investigational New Drug (IND) application, or equivalent, in the second half of 2014, in order to advance our TKM-HBV program into a Phase I clinical study, with initial data available in 2015.
• We received an additional $1.5 million payment from Monsanto following completion of specified program developments
You basher do not have a clue as to what the company is , does or will be. You play the Technicals like surgeons chopping and making money with little moves. Others here are like the analyst that put a 26 dollar target on the stock before the EBOLA windfall. The Ebola run was nice but the company is so much more. GO@#$%^&* your self.
When was the last time 100 AID workers came down with the disease? IT DONT HAPPEN with what we are hearing about only body fluid transfer. They are right Your ignorance and stubbornness are only matched by blatant misleading statements. Lets see here is ten.....# 10 Dengue
Global deaths per year: 25,000-The WHO estimates that a whopping 2.5 billion people (two fifths of the World’s population) are at risk from Dengue.
# 9 Yellow fever
Global deaths per year: 30,000
# 8 Rabies 50,000 per year
# 7 Hantavirus- Global deaths per year: 70,000
# 6 Measles
Global deaths per year: 197,000
# 5 Hepatitis C
Global deaths per year: 500,000 related
# 4 Influenza
Global deaths per year: 500,000
# 3 Hepatitis B
Global deaths per year: 521,000
# 2 Rotavirus
Global deaths per year: 611,000 - According to the WHO, this merciless virus causes the deaths of more than half a million children every year.
# 1 Human immunodeficiency virus (HIV)
Global deaths per year: 3.1 million- A third of all AIDs deaths occur in sub-Saharan Africa and, according to recent estimates, HIV will affect 90 million people in Africa, leaving 18 million orphans.
The best one is NEVER BEFORE has antivirals stopped some thing like this............... You say there in no future in viral drugs? Are you high? There are more than 5,000 viruses known to man, and they are evolving every day. Medicine has been able to combat and eradicate some of the nasty little killers through the ages (such as smallpox and polio). However, there are still plenty of invisible beasties out there looking for their next victim.
are the hundred AID workers going to get the real deal or that ZMAPP that isn't any better then the disease running the infectious course? Barack needs to sent more doses and less military aid.
ZMapp to be made available to both Sierra Leone and Liberia," The FDA just made drugs that actually work available. Why would they want a drug that is only 40 to 60% effective. Please explain as test were a lot higher for TKMR at 100%. I would cover. Your hedge fund is going to loose a lot of money putting out #$%$ g0ing into the call. Smart shorts covered this morning.