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Fair questions. They were low on cash and had been waiting for the green light from Health Canada to start human trial for several months. Health Canada was supposed to give them a decision in H1’18 but they were heavily backlogged it seems. The company announced the offering on Oct 11. On Oct 16 they finally got the green light from HC. So when they announced the offering they did not know they when the trial would begin and that they’d have data in November.
I haven’t seen management buying stock from the open market but they haven’t been taking cash bonuses. All their compensation beyond salary has been equity-based. We can see this in both a positive or a negative light IMO.
They have also been disciplined about giving away equity. They have not done big raises. Their recent offering was for 1.28M shares for a sum of $2.7M only. This to me is a bullish sign that they are confident the human data won’t be bad because if it is, the next dilution would have to come at a very high cost.
MRKR vs. GRTS interesting thread on twitter.
https://twitter.com/thejadedtrader/status/1057320927225044992?s=21
No position.
Nice. Looking forward to RSNA 2018 Nov 25-30. There will be approx. 55,000 attendees. They should have data by then. Hopefully it’s good.
http://investors.endrainc.com/prviewer/release_only/id/3386938
ESPR Announces Completion of Phase 3 LDL-C Lowering Development Program of Bempedoic Acid and Positive Cumulative Results
http://investor.esperion.com/news-releases/news-release-details/esperion-announces-completion-phase-3-ldl-c-lowering-development
– Phase 3 Program Achieved Safety and Tolerability Objectives –
– Bempedoic Acid Achieved Additional 18% to 31% LDL-C Lowering in Patients on Maximally Tolerated Statins and Provided Additional 19% to 33% hsCRP Reduction –
– 5-Component MACE Events in the Bempedoic Acid Arm were 4.0% as Compared to 4.6% for Placebo –
– Reduction in HbA1c of 0.19% to 0.31% in Patients with Diabetes –
– NDA submissions expected during 1Q 2019
It’s NDRAW. (EOM)
[OT]“This robot uses the capability of legs and the efficiency of wheels”
This robot uses the capability of legs and the efficiency of wheels@ASMEdotorg @IIoT_World @CRudinschi #Engineering #Robots #Robotics #Automation #Manufacturingpic.twitter.com/gHrThS9LxC
— Dr. Hassan Rashidi (@DrHassanRashidi) October 25, 2018
Short video on TAEUS.
At ENDRA, we developed TAEUS – a platform technology to revolutionize what doctors see and do at the patient bedside. But what is TAEUS?
— ENDRA (@endralifesci) September 19, 2018
Click below to watch our new video overview of our TAEUS platform, which addresses one of the most prevalent problems in healthcare today. pic.twitter.com/wBvElb4Kjt
NDRA (+17%) first ever close above $5 since IPO in May 2017
NDRAW (+30%) unusually high volume with price red or only up a little for most of the day.
TAEUS data next month. Company also participating in 3 liver disease and imaging conference in November.
F.D.A. Approves New Drug for Flu
—The new drug, sold as Xofluza, is about as effective as Tamiflu in shortening flu symptoms, and is expected to work against drug-resistant strains.
https://www.nytimes.com/2018/10/24/health/flu-pill-xofluza.html
The first new flu drug in 20 years won approval Wednesday from the Food and Drug Administration.
The new antiviral, generically known as baloxavir marboxil but sold under the brand name Xofluza, is a single dose treatment. It is for use only in those aged 12 or more, the F.D.A. said, and should be taken only in the first two days after symptoms like fever, aches and sniffles appear.
The pill will cost $150, according to a spokeswoman for Genentech, which will sell Xofluza in this country. Genentech will offer coupons that lower the price to $30 for patients with health insurance and to about $90 for the uninsured.
Flu season has already begun, and last year’s was one of the most lethal in decades; about 80,000 Americans died of flu or its consequences, the Centers for Disease Control and Prevention said earlier this month.
The new drug is no miracle cure and it is not approved for young children, who are one of the most vulnerable groups, so the C.D.C. still strongly recommends that every American over the age of six months get a flu shot as soon as possible.
...
NDRA—Back to NAFLD
Widespread screening is not currently feasible given that a definitive diagnosis of NASH can only be made through identification of the characteristic histopathologic pattern on liver biopsy. While liver biopsy remains the gold-standard, its disadvantages are well known,” Saumya Jayakumar, MD, from the University of California in San Diego, and colleagues wrote. “There is a pressing unmet medical need for reliable and accurate noninvasive tools to evaluate steatosis and fibrosis in patients with NASH, and to monitor response to treatment.”
NDRA—
Other indications are also planned.
Currently, there are two commercially available preclinical photoacoustic im- aging systems as shown in Figure 3: Vevo LAZR (Fujifilm VisualSonics, Toronto, Canada; technology licensed from Seno Medical Instruments, San Antonio, Tex) and Nexus 128 (Endra, Ann Arbor, Mich; technology licensed from OptoSonics, Oriental, NC) (7,44– 49). Vevo LAZR uses high-frequency handheld transducers ranging from 9 to 55 MHz, which limits its use to small-animal imaging, while the Nexus 128 employs a 5-MHz hemispherical transducer array for photoacoustic CT which is potentially suitable for clinical imaging (however, currently not cleared by FDA for human use).
Exercise price $6.25 and expire in 4 years.
The new federalism: blockchain will decentralise big tech’s power on the internet
http://blogs.lse.ac.uk/businessreview/2018/07/12/the-new-federalism-blockchain-will-decentralise-big-techs-power-on-the-internet/
Same sentiment in this article as well.
Deep patent pool.
The development and protection of intellectual property ("IP") in thermoacoustic clinical applications is a key area of focus for ENDRA. To further that goal, the company currently has two patent agents embedded within the applied science team, working to define and secure IP to support ENDRA's innovations. As of today, ENDRA's IP portfolio totals 37 patents and patent applications that are in preparation, filed, issued or licensed, encompassing a range of device and method-focused IP in targeted global markets.
Competition is healthy. However, just some high level observation: Echosens partnered with GE in April 2017. GE and Endra renewed and extended their partnership in February 2018. Perhaps GE felt more to be desired from a device in this area than what it was getting from Echosens.
ENDRA Life Sciences Renews and Extends Term of Collaboration Agreement with GE Healthcare to Develop ENDRA's TAEUS(TM) Clinical Product Targeting Non-Alcoholic Fatty Liver Disease
http://investors.endrainc.com/prviewer/release_only/id/2926860
Under the terms of the agreement, GE Healthcare will continue to support ENDRA's efforts to complete commercialization of its TAEUS technology for use in a fatty liver application by, among other things, providing equipment and technical advice, and facilitating introductions to GE Healthcare clinical ultrasound customers. In return for this assistance, ENDRA will afford GE Healthcare certain rights of first offer with respect to manufacturing and licensing rights for the target application.
Impressive value proposition in NAFLD by enhancing ultrasound.
https://endrainc.com/clinical/liver-disease.html
Also thanks for your insights. I was curious what metric they would use to quantify the success of the images. I realize we have to think differently with medical devices.
Great to hear you are invested as well, biotech_researcher. I also believe GE will take over eventually and use their clout to have the device installed in clinics around the world. Being the second largest maker of diagnostic imaging devices, GE would want to move the strategic partnership to the next level and add this machine to their portfolio instead of see it taken by a competitor IMO.
Top ten diagnostic imaging device manufacturers
https://www.hospitalmanagement.net/features/featuremedical-imaging-technology-diagnostic-device-manufacturers/
2. GE Healthcare
GE Healthcare, a business unit of General Electric Company, provides transformational medical technologies and services, as well as consulting services. With headquarters in Buckinghamshire, UK, it carries out the design, development, manufacture and distribution of medical systems in the field of medical imaging and information technologies, medical diagnostics, patient monitoring, drug discovery, and biopharmaceutical manufacturing technologies.
GE Healthcare also provides services, such as performance improvement and solutions services, computerised data management, and remote diagnostic and repair services of medical equipment manufactured by the company and others.
GE Healthcare’s products are used in cardiology; neurology; emergency medicine; oncology; woman’s health; ear, nose and throat (ENT); musculoskeletal; emergency care; radiology; paediatrics; urology and in the obstetrics/gynaecology areas. The company recorded revenue of $18.1 billion during the fiscal year ended December 2011.
The company’s business is divided chiefly into five segments: surgery, healthcare systems, life sciences, medical diagnostics and healthcare IT.
The medical diagnostics segment is engaged in the research, manufacture and marketing of innovative imaging agents, which are used in medical scanning procedures to highlight organs, tissues and functions inside the human body. These agents help physicians in the early detection, diagnosis and management of diseases. The company’s diagnostic imaging products include ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), mammography, molecular imaging, nuclear medicine, positron emission tomography (PET), radiopharmacy, pre-clinical imaging, radiography and radiography, and fluoroscopy systems.
In August 2012, the company received CE marking for its Discovery IGS 730, interventional X-ray system. It has introduced the Optima NM/CT 640 – the latest addition to its Nuclear Medicine 600 series with a new performance SPECT/CT system.
NDRA +29% (+16% AH) today in anticipation of TAEUS data next month
Investment Thesis: Once MDGL/VKTX get to market, there will be a big increase in new prescriptions written in this space. Will the current capacity of MRI machines and radiologist manpower be sufficient to handle the increased screening of new patients? Probably not. Endra Life Sciences has a value proposition with TAEUS (Thermo Acoustic Enhanced Ultrasound) at 50X less cost.
- Strategic partnership with GE Healthcare
- CEO and two board members GE Healthcare veterans
- $13B addressable market
- Very favorable capital structure
Some tweets of interest:
https://twitter.com/thejadedtrader/status/1044227952811040773
Liver Biopsy is the gold standard for NAFLD/NASH and remember it is expensive and carries morbidity and small mortality risk as well. Therefore if $ndra shows better data in early detection of NAFLD/NASH it will a big moment for the company
— Pharmdca (@Pharmdca) October 19, 2018
Can a Liver Ultrasound Diagnose a Fatty Liver Accurately?
The characteristics of a fatty liver include a hyperechoic liver where the echo-texture of the liver is brighter than the kidney and blurring of vascular margins. These are relatively sensitive but nonspecific findings and can also be seen in many other causes of chronic liver disease. They do not provide any distinction between steatosis and steatohepatitis and, in the absence of ascites and overt findings of portal hypertension, provides no information on the stage of the disease. It is, however, the least expensive of the imaging modalities available for evaluation of fatty liver disease and is therefore commonly used. The specificity for the diagnosis of hepatic steatosis can be improved with a computed tomography (CT) scan or magnetic resonance imaging (MRI) but with an exponential increase in the cost of the procedure. Also, neither a CT scan nor an MRI can distinguish between NAFL and NASH and have the same limitations with respect to fibrosis as an ultrasound.
Waltham's Morphic Therapeutic inks $100M deal with AbbVie
https://www.bizjournals.com/boston/news/2018/10/18/walthams-morphic-therapeutic-inks-100m-deal-with.html
A preclinical Waltham biotech company is hoping to launch its first clinical trial of a fibrosis treatment next year after signing a $100 million collaboration agreement with AbbVie this week.
Morphic Therapeutic is partnering with AbbVie to develop drugs that could halt organ-harming tissue buildup resulting from chronic inflammation in the lungs or liver. AbbVie (NYSE: ABBV) will pay $100 million up front for exclusive licensing rights to any drugs developed, and will be responsible for global development and commercialization.
GE’s $500B Market Wipeout Is Like Erasing Facebook
https://www.bloomberg.com/news/articles/2018-10-01/ge-s-500-000-000-000-market-wipeout-is-like-erasing-facebook
Blockchain could improve transparency in Africa’s commodity market
https://qz.com/africa/1401915/blockchain-could-help-africas-commodity-markets-says-ideanomics-ceo-bruno-wu/
AT&T Announces Suite of Blockchain Solutions
http://about.att.com/story/2018/att_blockchain.html
GERN -62%/PM announces discontinuation of Imetelstat collaboration by Janssen
http://www.proactiveinvestors.com/companies/news/205870
Blockchain Hype May Finally Turn Into Reality in Pharmaceuticals
https://www.bloomberg.com/news/articles/2018-09-26/blockchain-hype-may-finally-turn-into-reality-in-pharmaceuticals
Walmart, Sam's Club Start Mandating Suppliers Use IBM Blockchain
https://www.bloomberg.com/amp/news/articles/2018-09-24/walmart-sam-s-club-start-mandating-suppliers-use-ibm-blockchain
75 banks have joined JPMorgan's blockchain payments 'party'
https://www.yahoo.com/amphtml/finance/news/75-banks-joined-jpmorgan-apos-092040990.html
Blockchain tech is here to stay and will generate cost savings in billions to any industry that adopts it. Even if participants don’t care about enhanced operations, they can’t ignore cost savings for too long and will be pulled into considering this tech. Above are only a few examples of the adoption.
Congrats!
Jefferies on $AMRN Model U.S.peak sales could reach $2B, ~$15/share (upside scenario). see M&A potential.
Share could trade up into AHA Meeting and sNDA approval.
Jefferies on $AMRN Model U.S.peak sales could reach $2B, ~$15/share (upside scenario).
— Marc Lehman (@markflowchatter) September 24, 2018
see M&A potential.
Share could trade up into AHA Meeting and sNDA approval.
TLRY +40% PM.
Tilray Goes Parabolic: Stock Soars 40% Premarket, Market Cap Hits $20 Billion https://t.co/nUmRPDT3AW
— zerohedge (@zerohedge) September 19, 2018
TLRY + 26% on plans to import cannabis to U.S. for clinical trial
https://www.marketwatch.com/story/tilray-to-import-cannabis-to-us-for-clinical-trial-2018-09-18
— U.S. Drug Enforcement Administration approves testing of pot pills for essential tremor
SP was only $22 just a month ago. Now $151.
Fun facts:
Cannabis is becoming legal nationwide in Canada starting October 17
Price to Sales ratios...$FB: 9.8$AAPL: 4.4$AMZN: 4.8$NFLX: 12.0$GOOGL: 6.6
— Charlie Bilello (@charliebilello) September 13, 2018
Tilray $TLRY: 349 pic.twitter.com/aHY1jEtn5C
Tilray, a cannabis company w/ $28 million in sales & -$21 million net income, passed Ralph Lauren ($6.2 billion sales) and Tractor Supply ($7.6 billion sales) in Market Cap yesterday. Via @charliebilello $TLRY pic.twitter.com/ZTd4jctwm1
— Steve Burns (@SJosephBurns) September 14, 2018
I was long VKTX (with a position which would have been 6 figures today) but exited way back unfortunately due to potential concerns around elevated liver enzymes. No regrets though. Felt right at the time. I wish both companies that best. There’s always room for more than one player in any industry. Cheers!
best efficacy. new leader in NASH space. $VKTX
best efficacy. new leader in NASH space. $VKTX https://t.co/j2BP0QKL4n
— avidresearch (@avidresearch) September 18, 2018
$VKTX 67% of pts saw liver fat cut in half
VKTX +128% /PM on topline p2 VK2809 data
https://seekingalpha.com/news/3391005-viking-therapeutics-vk2809-successful-mid-stage-nafld-study-shares-128-percent-premarket
Viking Therapeutics (NASDAQ:VKTX) is up a whopping 128% premarket on robust volume in response to its announcement of positive results from a Phase 2 clinical trial evaluating VK2809 in patients with nonalcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C).
The study met the primary endpoint of a statistically significant reduction in LDL-C versus placebo and also showed a statistically valid reduction in liver fat compared to placebo.
Specifically, the median change in liver fat was 58.1% versus 8.9% for control. The proportion of patients achieving at least a 30% reduction in liver fat was 83.3% compared to 18.2% for control.
VK2809 was well-tolerated with no serious adverse events reported.
Complete results will be submitted for presentation at The Liver Meeting in San Francisco, November 9-13.
Management will host a conference call this morning at 8:00 am ET.
Over 500% increase in institutional ownership in Q2 FWIW.
https://whalewisdom.com/stock/ontx-2
https://fintel.io/sob/us/ontx
ONTX—Anyone have any thoughts on their CDK 4/6 ARK 5 inhibitor?
https://twitter.com/thejadedtrader/status/1040654947333754880?s=21
https://twitter.com/thejadedtrader/status/994391744862081025?s=21
https://twitter.com/thejadedtrader/status/998307830758174721?s=21
Or big tobacco...
Seven reasons Big Tobacco is likely to make a move on the marijuana industry
https://on.mktw.net/2CGcPMA
One big beverage/pharma deal with upfront payment and this could fly to $10+ overnight IMHO. Exciting times.
The Secret Drug Pricing System Middlemen Use to Rake in Millions
https://www.bloomberg.com/graphics/2018-drug-spread-pricing/
Per today’s PR, expect more supply agreements in the future. If I had to guess within the next few weeks as things will need to move fast with Oct 17 approaching.
“We’re proud to work with the NLC as a preferred Licensed Producer to serve Newfoundland and Labrador in the upcoming legal cannabis market,” said Chris Wagner, CEO at Emerald. “This represents the third provincial agreement for our team and we expect to share additional supply updates in the future.”
What’s holding the valuation back is the OTCBB listing. They need to uplist to Nasdaq or NYSE soon to enable all US institutional investors to participate. Many cannot simply because their investing mandates bar them from investing in pink sheet stocks.
There goes $emhtf mentioned 2 days ago in 3.20s now 3.80s - and what typically culminates out of these strong C & H break outs is 3 white soldiers pattern. You can clearly see 1st white soldier on right Look for 2 more next week and a move to $5+