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IBI Research On Verastem: Will Copiktra Saves The Day?
https://seekingalpha.com/instablog/17806842-biosci-capital-partners/5307919-ibi-research-verastem-will-copiktra-saves-day
Verastem Oncology to Present New COPIKTRA(TM) (Duvelisib) Dose Modification Data from Patients Treated in the Phase 3 DUO Study
5:16 pm ET May 15, 2019 (BusinessWire) Print
--Dose Interruptions of a Median 15 days Do Not Significantly Impact Response or PFS
--Data Demonstrate That Dose Modifications Can be Used to Effectively Manage Adverse Events
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced a poster highlighting dose modification data from the Phase 3 DUO study evaluating COPIKTRA (duvelisib) in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. The poster, entitled "Effect of dose modifications on response to duvelisib in patients with relapsed/refractory (R/R) CLL/SLL in the DUO trial," will be presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting, taking place May 31 - June 4, 2019, in Chicago. COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval from the U.S. Food and Drug Administration (FDA) for this same indication in September 2018.
"Duvelisib is a potent oral dual inhibitor of PI3K-delta and -gamma with robust activity in patients with CLL/SLL after at least two prior therapies," commented Ian Flinn, MD, PhD, Director, Lymphoma/CLL Program at Sarah Cannon Research Institute and lead investigator of the DUO study. "These new data demonstrate that dose modifications may be used to manage treatment-emergent adverse events (TEAEs) while allowing patients to remain on therapy, and that dosing interruptions of a median 15 days do not appear to negatively impact response to Duvelisib or progression-free-survival (PFS)."
"Notably, these data also show that when adverse events of special interest (AESIs) occur, they tend to show up in the first few months of treatment, then the proportion of patients experiencing AESIs decreases," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We look forward to sharing these data with the scientific and medical communities at ASCO this year."
Effect of Dose Modification on Response to COPIKTRA in Patients with Relapsed or Refractory CLL/SLL in the Phase 3 DUO Study
The randomized, multicenter, open-label, Phase 3 DUO study, compared COPIKTRA versus ofatumumab in 319 adult patients with CLL (n=312) or SLL (n=7) after at least one prior therapy. The study randomized patients with a 1:1 ratio to receive either COPIKTRA 25mg twice daily until disease progression or unacceptable toxicity, or ofatumumab, an approved standard of care treatment for use in CLL/SLL, for 7 cycles. This analysis examined dose modification patterns and their impact on response to COPIKTRA. Dose interruptions (DI) or dose reductions (DR) to 15mg, 10mg or 5mg twice daily were permitted per study protocol to manage TEAEs. Responses were assessed per an Independent Review Committee (IRC).
Among the 158 COPIKTRA-treated patients in the DUO study, the median duration of exposure was 11.6 months, versus 5.3 months for patients treated with ofatumumab. The most common cause of DI was diarrhea (23%), followed by neutropenia (12%) and pneumonia or colitis (11% each). Among responders (n=118), median time to first response on COPIKTRA was 1.9 months and the estimated median duration of response was 11.1 months. Median time to first DI was 3.9 months and median duration of DI was 15 days (range 1 to 133 days). Response to COPIKTRA was improved or maintained in most patients evaluated for response who had at least one DI for >1 week (84%) or >2 weeks (82%) followed by at least 3 weeks on COPIKTRA. In a landmark analysis, median PFS was similar in patients with DI and those without DI for >1 week (17.8 versus 16.3 months) or >2 weeks (17.8 versus 16.3 months) within the first 3 months. The median time to DR after a complete response or partial response was 5.6 months (n=25) and median duration was 3.4 months. Median time to onset across AESIs after starting COPIKTRA ranged from 2.2 to 4.3 months. Median time to resolution was within 4 weeks across AESIs. Proportions of patients experiencing AESIs were stable or decreased over time after 3-6 months: 0-3 months, 64%; >3-6 months, 63%; >6-9 months, 47%; >9-12 months, 52%, and seldom led to discontinuation of COPIKTRA (less-than or equal to10%). These findings support the thesis that DI or DR can be useful in effectively managing TEAEs with COPIKTRA and that DI of >1-2 weeks or more do not appear to significantly impact response to COPIKTRA or PFS.
A PDF copy of this poster presentation will be available here following the conclusion of the presentation.
Details for the ASCO 2019 presentation is as follows:
Title: Effect of dose modifications on response to
duvelisib in patients with relapsed/refractory (R/R) CLL/SLL in
the DUO trial
Lead author: Ian Flinn, Sarah Cannon Research Institute
Session: Hematologic Malignancies - Lymphoma and Chronic
Lymphocytic Leukemia
Poster Board#: 277
Abstract #: 7523
Location: McCormick Place, Hall A
Date and Time: Monday, June 3, 8:00 - 11:00 a.m. CT
Important Safety Information
TG Therapeutics Inc. (TGTX)
https://dividendbot.com/?s=tgtx
The 3 Largest Stocks Now Scoring Worse Than Tesla Before Its 40% Decline
One should be aware that the lower gap made back in March 2019 will likely be filled and the stock has move back up more than 57% at one point from the December 2018 lows.
There's also not likely to be any new catalyst given at these conferences.
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming data presentations at the 55 American Society of Clinical Oncology (ASCO) annual meeting, to be held May 31 - June 4, 2019, in Chicago, Illinois; the 24 European Hematology Association (EHA) annual congress, to be held June 13 - 16, 2019, in Amsterdam, Netherlands; and at the 15 International Conference on Malignant Lymphoma (ICML), to be held June 18 - 22, 2019, in Lugano, Switzerland.
https://seekingalpha.com/article/4265870-3-largest-stocks-now-scoring-worse-tesla-40-percent-decline
An excellent statement on current outlook, I couldn't agree with you more. Others will be chasing this one later at a higher prices again.
TG Therapeutics: Varied Pipeline With 2 Lead Candidates In Late Stage, Low Cash Position
https://seekingalpha.com/article/4263735-tg-therapeutics-varied-pipeline-2-lead-candidates-late-stage-low-cash-position
OIL: The Bullish Picture Brightens
https://seekingalpha.com/article/4264509-oil-bullish-picture-brightens
leftovers
I think $T`s in the sweet spot with all`s that`s going on. GLTU
Oil Rises 1% on Supply Concerns After Attacks on Saudi Facilities
https://www.marketpulse.com/20190514/oil-rises-1-supply-concerns-attacks-saudi-facilities/
jimmy667
May be good script numbers are leaking out again plus being way oversold with short covering going on too. Hang in there if you can, GL
Publication in Annals of Internal Medicine® Reveals T2Bacteria® Panel as the First Direct-from-Blood, Non-Culture Test that Rapidly Diagnoses Bacterial Bloodstream Infections
Study demonstrates patients tested with T2Bacteria can get started on the proper therapy sooner
LEXINGTON, Mass., May 14, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of innovative diagnostic products for critical unmet needs in healthcare, today announced that results from a pivotal trial were published online in the Annals of Internal Medicine® journal. The study, "Performance of the T2Bacterial Panel for Diagnosing Bloodstream Infections. A Diagnostic Accuracy Study," demonstrated decisive evidence for the first direct-from-blood, non-culture test cleared by the U.S. Food and Drug Administration (FDA) for the diagnosis of bloodstream infections by multiple bacteria.
The T2Bacteria® Panel received FDA clearance in May 2018 and is the first and only FDA-cleared test to identify sepsis-causing bacteria directly from whole blood without the wait for blood culture, which currently takes 1 to 5 or more days and is the current standard of care for diagnosing bloodstream infections (BSIs). The panel delivers results in three to five hours for the most common ESKAPE bacteria Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa and Escherichia coli.
“With a blood culture, it typically takes days to cultivate organisms to learn if a patient has bacteremia and, if so, what bacteria is causing the infection. Additionally, blood cultures are not always sensitive enough to pick up the presence of bacteria in the bloodstream, such as when the patient has already been started on antibiotics,” said M. Hong Nguyen, M.D., University of Pittsburgh Department of Medicine, and lead author of the study. “There are well known limitations with relying solely on blood cultures. Technology that can deliver pathogen results in a matter of hours from initial blood draw, a capability which is unlike any other FDA-cleared device in the market today, can allow clinicians to approach initial clinical BSI treatment in a more informed way.”
The pivotal data exhibited the advantages that the T2Bacteria® Panel, which runs on the T2Dx® Instrument, can provide in diagnosing BSIs.
Key Study Findings
The multi-center study enrolled and collected blood specimens from 1,427 patients who had a blood culture ordered as part of the standard of care. In the pivotal trial, the T2Bacteria® Panel and T2Dx® Instrument demonstrated:
Blood cultures took between 32 and 111 hours to identify pathogens whereas the T2Bacteria® Panel took 3.6 to 7.7 hours to do so.
In 78% of probable or possible BSIs, subjects had blood culture-negative/T2Bacteria positive results despite treatment with active antibiotics.
24 hours after blood draw, 20% of patients with blood culture-positive/T2bacteria-positive results were still not receiving effective therapy.
The T2Bacteria® Panel had a 99.7% negative predictive value.
The T2Bacteria® Panel had overall sensitivity of 89.7% per subject and per assay.
The T2Bacteria® Panel had overall specificity of 89.5% per subject and 97.8% per assay.
“This study clearly demonstrates that there are shortcomings with the sensitivity and speed of blood culture results and that the T2Bacteria® Panel can shorten the time to appropriate antibiotic treatment in patients, a huge step in the right direction for improving clinical outcomes. Timely administration of appropriate treatment might also help reduce hospital costs, such as by reducing length of stay, another added benefit to this technology,” said Nguyen. “Now that we have this information, it’s crucial for clinicians to come together to understand how to incorporate this technology into rational patient management and antibiotic stewardship strategies.”
The T2Bacteria® Panel is part of a suite of products including the T2Candida® Panel—the first and only direct-from-blood detection panel that provides same-day results for the most clinically relevant fungi. For efficiency, both panels run on the same T2Dx® Instrument, a fully automated, walk away, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood.
“We are pleased that the results from our 1,427 patient pivotal study of the T2Bacteria Panel are now available for clinicians,” said Dr. Sandy Estrada, vice president medical affairs of T2 Biosystems. “Since the completion of this study in August 2017, we have secured FDA clearance and launched the T2Bacteria Panel in the U.S. and Europe. The initial commercial experience appears to be aligned with the strong results demonstrated in the pivotal study, as several customers have shared case studies of the T2Bacteria Panel providing actionable test results that improved patient care and several have developed and implemented patient selection criteria for the ICU, oncology units and the Emergency Department. We continue to engage with clinicians, stewardship teams and laboratory personnel at hospitals as they expand utilization of the T2Bacteria Panel and develop independent data examining its clinical and cost-savings benefits, similar to what we have already seen with the T2Candida Panel.”
About T2 Biosystems
T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.
Media Contact:
Gina Kent, Vault Communications
gkent@vaultcommunications.com
610-455-2763
Investor Contact:
Zack Kubow, W2O Group
zkubow@w2ogroup.com
415-658-6436
http://investors.t2biosystems.com/news-releases/news-release-details/publication-annals-internal-mediciner-reveals-t2bacteriar-panel
Source: T2 Biosystems, Inc.
Just more positive news. Thanks
Looking like tomorrow is going to be another selloff in the broader markets.
https://www.investing.com/indices/indices-futures
Don`t forget currently $VSTM has these ongoing trials and more could be added per the conference call as Forrester stated there is still a lot of interest coming in for Defactinib combination usage:
May 2019
ClinicalTrials.gov Identifier: NCT02758587
Pancreatic Neoplasms / Drug: Defactinib
September 2019
ClinicalTrials.gov Identifier: NCT02004028
Malignant Pleural Mesothelioma / Drug: Defactinib VS-6063
July 31, 2020
ClinicalTrials.gov Identifier: NCT02546531
Advanced Cancer / Defactinib Combined With Pembrolizumab and Gemcitabine
Start April 2019 (Feb 2023)
ClinicalTrials.gov Identifier: NCT03727880
Pancreatic Ductal Adenocarcinoma / Drug: Defactinib
June 30, 2022
ClinicalTrials.gov Identifier: NCT02465060
Glioma / Drug: Defactinib
September 2023
ClinicalTrials.gov Identifier: NCT03287271
Carboplatin-resistant Ovarian Cancer / Defactinib (VS-6063) +Carboplatin/Paclitaxel
A Bullish Outlook For Oil Investors
https://seekingalpha.com/article/4262894-bullish-outlook-oil-investors
Click on link below. This is the only way I could post it on Investors Hub. Happy reading. I bought a boatload this morning to bring down my average. The 35% sell off was way overdone. IMO
Latest Research Report
VSTM 05/10/19 07:46am Verastem analyst commentary at BTIG Verastem price target lowered to $8 from $17 at BTIG. BTIG analyst Robert Hazlett lowers his price target on Verastem to $8 after its Q1 results featured a more modest 2019 sales guidance for Copiktra at $10M-$12M - below his estimate of $50M. The analyst contends that the guidance suggests overcoming the challenges of Copiktra launch will take longer than anticipated, adding that he is also removing the possibility of M&A from his model. Hazlett keeps his Buy rating on the stock however and still believes in Copiktra's potential to "materially disrupt the tumor microenvironment.
Semms this is now selling off over trade fears and institutional money managers selling so they can buy the Uber IPO.
As the fundamentals continue to look better i'm buying even with the lowered guidance.
Thanks for posting the article.
Another article on $TTOO that needs some rubital from the bull side. This one is posted to Seeking Alpha and is super negative.
Conclusion
Our notes from the ECCMID Conference confirmed that the T2 direct from blood testing platform is prone to a significant shortcoming, which is the need to run a large number of expensive but meaningless tests on the patients with negative blood cultures. In the absence of a clear algorithm on how to pre-select patients with positive blood cultures for the T2 test (one exception is immune-compromised patients), the future of TTOO is doomed, because with its $150-$200 per panel cost it cannot compete with the relatively fast, extremely inclusive and bottom rock cheap MALDI ID test of $0.50 per test.
https://seekingalpha.com/article/4261049-research-2019-eccmid-conference-reveals-grim-outlook-t2-biosystems
Why Oil Traders Should Be Focusing On Saudi Arabia, Threats Of Supply Crunch
The two predominant issues impacting the oil market right now appear to be the state of U.S.-China trade negotiations and U.S. oil stockpiles. However, traders should not lose sight of Saudi Arabia’s oil production and export plans for May and June, because these will impact the supply and demand balance much more significantly in the coming weeks and months.
On Sunday night and Monday morning, oil prices fell when it appeared that trade talks between China and the U.S. would break down, which in turn re-ignited fears that an ongoing trade war will lead to a recession and demand for oil will fall as a result.
This kind of movement in the market is really the result of traders acting based on their perception of how other traders and computer algorithms will react. It is not an actual reaction to a potential economic downturn, because that downturn is not on the immediate horizon, even if it does eventually materialize. After a brief recovery on Monday, prices fell again on Tuesday as similar fears dominated the marker. Just two days later, on Wednesday morning, oil prices rose as the outlook on a U.S.-China trade deal seemed more positive.
Weekly EIA data on U.S. stocks has also had an impact on prices over the past few weeks. Last week, EIA figures showed a large build in oil stocks, and prices dropped. This week, they showed an unexpected draw, and oil prices rose a little.
However, when looking at global supply, these factors should be overshadowed by news coming from Saudi Arabia and Aramco. The primary question is whether Saudi Arabia will increase its production and exports to replace Iranian oil that will come off the market due to tightening U.S. sanctions. U.S. President Donald Trump and the State Department have said that Saudi Arabia will put more oil on the market, but the Middle-Eastern country has repeatedly said that it will only act to increase production in response to customer demand.
Now that orders are coming in for oil shipments for June, we are getting a better picture of how this is shaping up. According to Energy Intelligence, Saudi Arabia plans to produce between 10 and 10.3 million bpd in May. The increase, however, is mainly due to higher domestic demand for oil and gas in the kingdom as temperatures rise and electricity demand grows, especially during this month of Ramadan.
Saudi Arabia does not plan to increase its exports much above its April numbers of 7 million bpd. An official stated that the country has received requests for oil from customers who were previously importing Iranian oil for the month of June and that all of these requests will be met while maintaining the kingdom's 10.3 million bpd production quota. In fact, Saudi Arabia intends to keep its exports to just under 7 million bpd in June, a relatively low number. Aramco also raised the prices on its oil sold to Asian customers for June lifting. These are all indications that we should expect oil supplies to tighten in May and June.
Saudi Arabia has been clear that it is only willing to supply more oil to Iran’s former customers if they are willing to pay more. These customers have been buying Iranian oil at cheaper prices and have also received discounts on shipping and insurance costs. Unless customers are willing to defy U.S. sanctions on Iranian oil, Saudi oil prices will rise. Traders should expect to see that reflected in the market.
This doesn’t touch on other factors hitting oil supply, like Venezuelan’s deteriorating production, unstable output in Libya and Russia’s recent oil contamination episode. To conclude, even though oil market news is dominated by hazy updates on U.S.-China trade relations and by the weekly ups and downs of U.S, inventories, traders should beware of a potential supply crunch, especially in Asia.
https://www.investing.com/analysis/why-saudi-arabia-threats-of-supply-crunch-are-the-real-ones-to-watch-for-oil-200419152
TG Therapeutics to Host Conference Call on First Quarter 2019 Financial Results and Business Update
https://seekingalpha.com/pr/17506151-tg-therapeutics-host-conference-call-first-quarter-2019-financial-results-business-update
Oil settles higher after surprise drop in U.S. crude stockpiles
U.S. crude oil bounced off one-month lows to finish higher after the government reported domestic inventories fell by 4M barrels, compared with an expected 1.2M-barrel increase; WTI settled +1.2% to $62.12/bbl, Brent +0.7% to $70.37/bbl.
Combined with growing tensions between the U.S. and Iran, the news outweighed concerns that a protracted U.S.-China trade conflict would hurt energy demand.
"Crude prices are stabilizing after making a five-week low and could see further upside if trade talks do not completely fall apart this week," says Oanda market analyst Edward Moya.
Also, Saudi Arabia reportedly is expected to keep its crude exports below 7M bbl/day in June, staying under its production quota in OPEC's current global supply deal, despite pressure from Pres. Trump to reduce oil prices.
https://seekingalpha.com/news/3461030-oil-settles-higher-surprise-drop-u-s-crude-stockpiles
T2 Biosystems to Showcase Breakthrough Rapid Diagnostics During 22nd Annual MAD-ID Meeting in Orlando, Florida
GlobeNewswire
LEXINGTON, Mass., May 08, 2019 (GLOBE NEWSWIRE) -- T2 Biosystems (TTOO), Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative medical diagnostic products for critical unmet needs in healthcare, announced today that the Company will highlight its products at the 22nd Annual MAD-ID (Making a Difference in Infectious Diseases) Meeting, The Antimicrobial Stewardship Meeting, which is taking place May 8 – 11, 2019 in Orlando, FL.
T2 Biosystems is the company behind the T2 Bacteria® Panel, the first and only FDA-cleared test to identify sepsis-causing bacterial pathogens directly from whole-blood in 3 to 5 hours without the wait for blood culture, allowing patients to be placed on targeted antibiotic therapy faster. The T2Bacteria panel is one of several panels that are approved or in development that are run on the Company’s T2Dx® Instrument, which is powered by miniaturized magnetic resonance (T2MR®) technology, and will be showcased in Booth #11 at MAD-ID.
“We are grateful for this opportunity to join faculty and attendees at the annual MAD-ID Meeting, as we know they share our deep-rooted commitment to the design and implementation of effective antimicrobial stewardship strategies,” said John McDonough, president and chief executive officer of T2 Biosystems. “Our proprietary diagnostic detection method is proven to achieve earlier targeted effective antibiotic therapy for patients suffering from bloodstream infections, a critical factor in combatting antimicrobial resistance. We look forward to our time at MAD-ID as a chance to educate clinicians on how they can make this groundbreaking technology a part of their stewardship programs.”
T2 Biosystems will host a satellite symposium, Rapid Species Identification Using T2Direct Diagnostics™ with Stewardship Interventions on Friday, May 10 from 6:30am to 8:00am in the Rosen Centre Hotel, Executive Ballroom H. The symposium will aim to increase knowledge on how rapid diagnostic technology-based assays can be successfully incorporated into antimicrobial stewardship programs and will feature several leading clinicians, including Debbie Goff, PharmD, FCCP, Associate Professor, from The Ohio State University Wexner Medical Center; Ryan Shields, PharmD, MS, Associate Professor of Medicine at the University of Pittsburgh Medical Center; Emily Weisz, PharmD, BCPS, Infectious Disease Clinical Specialist, Lee Health Community Health System; and Sandy Estrada, PharmD, Vice President, Medical Affairs, T2 Biosystems, and President Florida Society of Health-System Pharmacists (FSHP).
In addition, two scientific poster presentations will take place on Friday May 9 from 5:00pm to 6:30pm:
Incorporating T2Candida testing into rational antifungal management: A successful pilot study of diagnostic stewardship directed toward specific intensive care unit patients at-risk for sepsis due to invasive candidiasis (Ryan Shields, PharmD, MS, University of Pittsburg Medical Center)
Blood culture-independent rapid diagnostic technology for improvement of time to bacterial species ID and earlier targeted antibiotic therapy (Oscar Guzman, PharmD, T2 Biosystems)
The T2Bacteria Panel is complemented by the T2Candida® Panel, which is the first and only FDA-cleared fungal pathogen detection panel that is performed direct from a blood draw without the wait for blood culture. In addition, earlier this year, the Company announced that the FDA granted Breakthrough Device designation for the T2Resistance™ Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture. The 13 genes identified on the T2 Resistance Panel include some of the most clinically important, as they are largely resistant to antimicrobial drugs that, for certain patients, are crucial in the treatment of bacterial infections, including carbapenems, vancomycin, penicillin and more. Several of the genes detected by the panel are listed on the CDC’s Urgent Threat list for antibiotic resistance. The Breakthrough Designation allows T2 Biosystems to work closely with the FDA during the premarket review phase to ensure patients can have access to the benefits of this innovation as soon as possible.
About T2 Biosystems
T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.
Media Contact:
Gina Kent, Vault Communications
gkent@vaultcommunications.com
610-455-2763
Investor Contact:
Zack Kubow, W2O Group
zkubow@w2ogroup.com
415-658-6436
https://seekingalpha.com/pr/17505058-t2-biosystems-showcase-breakthrough-rapid-diagnostics-22nd-annual-mad-id-meeting-orlando
WTI crude oil futures market moving back up nicely now on the lower build.
U.S. crude supply rose 2.8M barrels last week, API says
The American Petroleum Institute reportedly shows a build of 2.8M barrels of oil for the week ending May 3, vs. a 6.8M-barrel build in the previous week.
Gasoline inventories reportedly show a draw of 2.83M barrels and distillate inventories show a draw of 830K barrels, while Cushing inventories had a build of 620K barrels.
https://seekingalpha.com/news/3460358-u-s-crude-supply-rose-2_8m-barrels-last-week-api-says
Square acquires conversational AI startup Eloquent Labs
Square has acquired conversational artificial intelligence startup Eloquent Labs to help its merchants improve customer service.
Eloquent Labs, which raised a $1.5 million seed round back in early 2017, offers to small businesses a conversational assistant named Elle. The idea is that Elle will help merchants with common customer service-related issues like returns, product tracking and FAQs.
“Eloquent’s conversational AI services are exactly the kind of technology that can level the playing field for businesses of all sizes by providing sellers efficient ways to interact with their customers,” Square wrote in a blog post. “The team will advance messaging across our entire ecosystem, and together we will build tools that leverage the latest in natural language processing research.”
There are a number of other startups in this space, including customer service software LiveChat, DigitalGenius and Olark. All three of those have raised more money than Eloquent Labs, which likely played a role in Square’s decision.
https://techcrunch.com/2019/05/07/square-acquires-conversational-ai-startup-eloquent-labs/
T2 Biosystems: Turning Point Achieved?
Another one of interest if you`ve not had a chance to read it.
https://seekingalpha.com/article/4260533-t2-biosystems-turning-point-achieved
I see this as a buying opportunity for once, others still don't. Anyone else have an opinion to add to this analysis on Seeking Alpha story?
T2 Biosystems: Encouraging Q1 Report, Concerns Remain
https://seekingalpha.com/article/4260827-t2-biosystems-encouraging-q1-report-concerns-remain?v=1557243405&comments=show
Summary
The company is in possession of a breakthrough technology for the detection of sepsis (can detect pathogens including candida auris in under 4 hours).
Q1 revenue exceeded the high end of guidance and management reiterated that full year revenue should double as compared to 2018.
A possible near-term catalyst for upside is results of the T2Bacteria Panel pivotal FDA clinical trial to be published in a peer-reviewed medical journal.
T2Lyme Panel is currently in a pivotal Phase 3 trial with very encouraging results so far and a $700 million market being targeted.
Concerns remain, including cash burn, near-term financing, CRG loan (and its terms) and difficulty with getting hospitals and labs to adopt the technology in a timely manner.
Shares of T2 Biosystems (TTOO) have fallen by roughly 75% since the company's IPO was priced at $11 in 2014. Over the past 3 years, the share price has lost roughly two-thirds of its value and so far in 2019 performance is slightly in the red as well (-6%).
While I've been vaguely aware of the company and its intention to commercialize diagnostic products to speed up treatment of patients, previously I didn't find it attractive enough to do more research. However, ROTY member Osmium Research (a veteran of the medical device space) shared some interesting commentary on the name (highlighted revenue growth and what it would take for the company to become a success story). I found these remarks even more interesting considering that when discussing most medical device companies (especially on the diagnostic side), Osmium often tends to fall into the skeptic camp due to his vast experience in the field.
Let's take a closer look at the current situation to determine if recent quarterly highlights and other news warrant taking a position in this small cap concern.
Chart
Figure 1: TTOO daily advanced chart (Source: Finviz)
Figure 2: TTOO 15-minute chart (Source: Finviz)
When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels to get a feel for what's going on. In the first chart (daily advanced), we can observe a sickening decline in the stock price in the second half of the year with multiple short-lived bounce attempts. In the second chart (15-minute), we can observe volume coming into the stock after a promising earnings report (potentially indicative of a good entry point).
Overview
In the presentation at Needham Healthcare Conference, management provided a solid overview of the core business, mission and future prospects. T2 is described as being in possession of a breakthrough technology for the detection of sepsis. The company's technology allows them to detect pathogens including candida auris in under 4 hours (C. auris making headlines again recently as Senator Charles Schumer urges federal government to declare public health emergency as it spreads across New York). T2Candida is already on the market, while T2Bacteria panel tests for blood-borne bacteria pathogens (cleared by FDA in late May of 2018 and now on the market as well).
Management states the company has the only system that detects pathogens direct from a blood draw (competition requires blood culture which could require days or weeks). The company projects 40,000 deaths preventable in the United States with T2 and management forecasts double-digit revenue growth (doubled revenue from 2017 to 2018, looking to do the same in 2019 and beyond).
Figure 3: Current empiric protocol versus T2 proposed protocol, time is of the essence (Source: corporate presentation)
Delays in treatment are a critical issue, as successful treatment of sepsis is dependent on the time it takes to get the patient appropriate therapy and thus save their lives. For every hour that goes by, the mortality rate goes up by 7 or 8%. To put this into context of our current healthcare system, sepsis costs U.S. healthcare around $27 billion (claims more lives than breast cancer, prostate cancer and AIDS combined). 1 in 5 surviving sepsis patients die within 2 years due to sepsis.
In addition to an important advantage in speed, T2 also boasts an impressive edge in accuracy (for bacteria 98% specificity/95% sensitivity, for Candida 99% specificity/91% sensitivity). Growing number of success stories for Candida panel are encouraging (health systems and hospitals reducing median stay by 7 days, avoiding unnecessary antifungal therapy in high % of patients, patients receiving the appropriate therapy in much smaller window of time).
As for the Bacteria Panel, studies (1400 patient samples across 11 hospitals) showed that T2 test was 2.5 times faster than blood culture (detected four more results than blood culture did). Management believes that target addressable market is in excess of $1.2 billion. An interesting fact is that one T2 instrument has the potential to generate $300,000 of revenue annually for the company (T2Dx platform placed in 175 hospitals with 89 contracts as of year-end 2018).
Figure 4: Reimbursement established across multiple care environments, economics attractive as adoption drives revenue (Source: corporate presentation)
As for the company's commercial strategy, management has chosen to focus on the United States, Europe and Middle East (30% international/70% US split so far). Commercial footprint is focused on the US with 16 sales representatives and 6 medical affairs liaisons, while internationally the company utilizes distributors.
Let's take a look at a few recent events to determine how they affect the bullish thesis.
Select Recent Developments
In late September, the company announced new data suggesting that its T2Lyme Panel is more accurate than other diagnostics identifying Borrelia infections in patients suspected of having early Lyme disease. A 2017 pre-clinical study in 21 patients with erythema migrans rash with suspected early Lyme disease assessed with multiple Lyme diagnostic devices. T2Lyme Panel was the most accurate compared to tissue culture with 78% positive percent agreement (PPA) and 100% negative percent agreement (NPA), which contrasts well to currently recommended diagnostic with 56% PPA and 92% NPA. Use of T2Lyme Panel resulted in less incidence of false positive results (in total has been evaluated against 558 negative samples with no false-positive result).
On February 27th, the company announced that the FDA granted Breakthrough Device designation for the T2Resistance Panel, which can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single blood sample without waiting for blood culture. Several genes detected by the panel have been identified by the Center for Disease Control as "Urgent Threat" for antibiotic resistance. One would hope that as a result of this designation and regular feedback from the FDA T2Resistance makes it to market in an accelerated fashion.
Lastly, on March 21st a regulatory filing from the company disclosed a catalog supply agreement with GE Healthcare Bio-Sciences for manufacture and supply by GE Healthcare of its proprietary superparamagnetic particles to be used in connection with the company's products. T2 Biosystems in turn was appointed non-exclusive reseller of said particles for life sciences research globally.
Other Information
At the end of 2018, the company reported cash and equivalents of $50.8 million and management guided for operational runway through March 2020. For the first quarter of 2019, the company reported total revenue of $1.8 million (exceeded high end of guidance by 20%) and product revenue rose 30% year over year to $1.3 million (reflecting an increase in testing volume and stable capital sales as more new customers selected the reagent rental model). The company also exceeded guidance with 11 T2Dx Instruments contracted as compared to prior guidance of 8 to 10 (more than double the 5 instruments for Q1 2018).
Despite the encouraging news, keep in mind that the company continues to burn cash at an alarming rate (operating margin was loss of $13.6 million and costs and expenses were $11 million). Weighted average shares outstanding rose by 23% to 44.3 million as a result of continued dilution.
Management reiterated full year guidance, with total revenue expected to double in 2019 as compared to $10.5 million in 2018 (Q2 revenue in the range of $1.5 million to $1.8 million reflecting continuing adoption of T2Bacteria and T2Candida Panel test sales and expanding T2Dx Instruments reagent rentals and sales in the U.S. and internationally). Management is guiding for securing of 70 to 80 T2Dx Instruments contracts in 2019 (12 to 14 in Q2). Operating expenses for Q2 are expected to be in the range of $10.5 million to $11.5 million. Based on these numbers I'd expect dilution via financing in the near term.
On the conference call, President and CEO John McDonough stated that as more customers who entered contracts in 2H 2018 come online during or after Q2, management expects T2bacteria panel volume and recurring revenue to ramp up (and that reagent rental program will account for the majority of new business in the US).
A possible near-term catalyst is results of the T2Bacteria Panel pivotal FDA clinical trial to be published in a peer-reviewed medical journal soon (currently accepted by top tier journal but embargo has yet to be lifted). Progression of the T2Lyme Panel (currently in pivotal Phase 3 trial) is also a significant growth driver considering the $700 million market being targeted. Also, keep in mind the company is partnered up with CARB-X to focus on drug-resistant bacteria and progress is ahead of schedule (expanding to include additional bacterial species and resistance markers).
As for institutional investors of note, Adage Capital Partners owns a small stake. Polaris Venture Partners disclosed a 4.2% stake and Goldman Sachs owns a 9.2% stake. History of some insider selling is not encouraging.
As for leadership, CEO John McDonough previously served as President at Cytyc Development Corporation (aided in expanding corporate revenue from $300 million to $750 million until it was acquired by Hologic for over $6 billion).
Final Thoughts
To conclude, T2 Biosystems is operating in an interesting space and truly creating value across the entire spectrum of healthcare (for patients, hospitals and system on the whole). From anecdotal information and clinical study data it appears the company is executing on its mission of getting patients on the right targeted therapy quicker, thereby reducing hospital stay, resistance and mortality. As a result, patient care is improving and this will be a fascinating story to continue following.
On the other hand, hospitals are very slow to change and the company likely has a difficult road ahead trying to convince them (and enough labs) to buy into this technology. As ROTY member Qj4714 put it, "T2 is better than blood culture, but is that enough for it to be game changer?" That's the big question at this point.
Given the current burn rate and low cash balance, not to mention the stock trading at a normal to rich valuation (11x price to sales TTM, 6 times price to forward sales), I cannot currently recommend a pilot position. The company still has a ways to go and a likely financing in the near term (break-even could be achieved in 2 years or so).
On the other hand, there should be a significant ramp-up in the second half of the year with revenues and near-term publishing of results of the T2Bacteria Panel pivotal FDA clinical trial in a peer-reviewed medical journal could provide a significant boost. The stock also has potential to be a "news runner" (see recent piece on more infections appearing in New York), as fear surrounding Candida auris and increasing rates of infection could make headlines and bring in momentum traders (as was observed with the Ebola stock bubble in 2014).
I look forward to revisiting after another quarter's progress and especially as the company gets a near-term financing out of the way.
Risks include dilution, slowing sales growth (unlikely in the near to medium term), disappointing data (i.e. for pivotal T2Lyme study, again unlikely) and drawn out timeline until the company can achieve break-even cash flow. Consider that the company also has a loan to CRG of $39 million or so (loan agreement requires certain annual revenue targets where the company is required to pay double the amount of any shortfall as an acceleration of principal payments and maintain a minimum liquidity amount). Competition in certain instances, such as from Accelerate Diagnostics' Pheno system, and the difficulty in getting hospitals to adopt the technology in a timely manner is also a factor to consider.
For our purposes in ROTY, I hope to revisit after a financing has taken place and we've seen a quarter or two of progress.
Buy The Pullback In Crude Oil
https://seekingalpha.com/article/4260768-buy-pullback-crude-oil
Agree, i'm buying dips as this is just a manufactured sell off that doesn't affect $ARQL in any way.
Oil reverses to close higher amid rising U.S.-Iran tensions
May 6, 2019 3:43 PM ET Carl Surran, SA News Editor
Crude oil futures closed higher in a volatile session as rising Middle East tensions ended up outweighing Pres. Trump's threat that he may raise tariffs on Chinese goods: July WTI settled +0.5% to $62.25/bbl after spilling as low as $60.04, and July Brent ended +0.6% to $71.24/bbl after hitting a low of $68.79.
The U.S. said over the weekend it is deploying a carrier strike group and a bomber task force to the Middle East to send a clear message to Iran that any attack on U.S. interests or its allies will be met with "unrelenting force."
Also, China reportedly is still preparing to send a delegation to Washington for trade talks despite Trump’s threat.
"As the developments have been digested today, the flurry of Trump tweets are being seen more as a negotiating tactic that has the potential to end the trade war rather than make it worse," says Sevens Report co-editor Tyler Richey, also noting the bounce off the key $60/bbl support level for WTI. "As a result, oil futures turned solidly higher into the afternoon on elevated volumes."
Also, Saudi Aramco reportedly raised prices for Asian and European customers while cutting those to the U.S., which some analyst interpret as a signal that the Saudis are not in a rush to increase oil supply ahead of next month’s OPEC meeting.
https://seekingalpha.com/news/3459347-oil-reverses-close-higher-amid-rising-u-s-iran-tensions
DeafTrader2
So I expect that UWT pops would heading down Monday morning . Oil price bubble begins tomorrow .
Your private message to me:
So I expect that UWT pops would heading down Monday morning . Oil price bubble begins tomorrow .
My message back to you:
Don`t have private messaging so just a salute to you on your short position. How's that working for you now?
$UWT $20.36 Day's Change $1.00 (5.17%)
Day's High $20.36
Day's Low $18.99
Crude Oil WTI Contract Futures
62.87 +0.94 +1.52%
13:59:26 - Real-time derived data. Currency in USD
https://www.investing.com/commodities/crude-oil
FirstNet Milestones: Platform Crosses Half-a-Million Connections, Expands Coverage and Capacity in 600+ Markets Nationwide
https://seekingalpha.com/pr/17500685-firstnet-milestones-platform-crosses-half-million-connections-expands-coverage-capacity-600
Why Investors Should Stop Worrying About Square's Guidance
https://finance.yahoo.com/news/why-investors-stop-worrying-square-160000815.html
TG Therapeutics, Inc. Announces Data Presentation at the Upcoming American Academy of Neurology 71st Annual Meeting
NEW YORK, March 12, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that data from the Phase 2 multicenter trial evaluating ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) has been selected for presentation at the upcoming American Academy of Neurology (AAN) annual meeting, to be held May 4 – 10, 2019 in Philadelphia, Pennsylvania. Final data from the core Phase 2 trial has been previously presented, most recently at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual meeting in Dallas, TX. In addition to highlighting the final Phase 2 data, the AAN presentation plans to include data from the open label extension (OLE), a trial made available to any patient who completed the core Phase 2 trial allowing them to continue treatment with ublituximab.
The abstract is available online and can be accessed via the below link or on the AAN meeting website at www.aan.com.
Presentation Details:
Title: Open Label Extension (OLE) of Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb) in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
— Presentation Date & Time: Tuesday May 7, 2019, 5:30 PM – 6:30 PM ET
— Session Title: Poster Session P3: MS Clinical Trials and Therapeutic Research
— Presenter: Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX
— Location: Pennsylvania Convention Center
— Abstract Number: 2055
These data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.
Following the presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com.
Aramco Cuts Oil Prices to U.S. as Trump Tightens Iran Sanctions May 5, 2019, 6:46 AM
Saudi Arabia, the world’s biggest oil exporter, cut June pricing for all crude grades to the U.S. and raised most pricing to other regions.
The kingdom’s pricing appears to be aimed at easing concerns over supplies to the U.S. after the Trump Administration ended waivers for buyers of Iranian oil, while still benefiting from rising demand for its crude in Asia and Europe.
Key Insights
Flagship Arab Light grade rises 70 cents to $2.10 a barrel over the Oman-Dubai benchmark, the biggest spread for the grade since July.
Analysts in a Bloomberg survey expected the premium to be $2 a barrel.
June pricing follows increases in Asia for May, reflecting short supply of heavy crudes in market.
Saudi Arabia is the first Gulf producer to release forward pricing each month and many countries price their crudes off of Aramco’s.
OPEC and its allies are committed to reducing supply of the heavy, high-sulfur grades that Saudi Arabia and other Gulf producers pump. U.S. companies are boosting supply of lighter grades from shale deposits.
https://www.bloomberg.com/news/articles/2019-05-05/aramco-cuts-oil-prices-to-u-s-as-trump-tightens-iran-sanctions
Agree, a lot of good news and action not priced in yet. Still in the sweet spot for healthcare/biotechs until end of July. Politics has been holding the sectors back, but has been good for trading
Square's (NYSE: SQ) first-quarter earnings results came in above expectations, but management's outlook for the second quarter disappointed. CFO Amrita Ahuja said she expects Square's adjusted revenue in the second quarter to come in between $545 million and $555 million. Analysts were expecting about $556 million, on average.
The disappointing near-term outlook combined with a slight underperformance in gross payment volume during the first quarter led investors to punish the stock. That's not surprising, considering shares were practically priced for perfection.
But long-term investors shouldn't worry about Square's second-quarter outlook. The company actually raised its guidance for the full year, and it's showing promising growth from one of its most important ancillary products.
Short-term pain, long-term gain
The table below shows Square's second-quarter and full-year adjusted revenue outlook compared to the analysts' consensus.
Square Q2 Outlook
Analysts Q2 Estimate
Square FY Outlook
Analysts FY Estimate
$545 million-
$555 million
$556 million
$2.25 billion-
$2.28 billion
$2.26 billion
While Square's second-quarter range comes in below analysts' expectations, the mid-point of the company's full-year outlook is now above expectations. Ahuja raised her guidance by $30 million for the full year, while the first quarter outperformed by just $7 million at the midpoint of the guidance provided in February. That suggests the factors that caused the outperformance in the first quarter will sustain higher revenue throughout the rest of the year.
Importantly, Square has historically outperformed its adjusted revenue guidance, including in each of the last eight quarters. The gap between guidance and outperformance has been narrowing, though, which is what may have scared investors when the outlook came in below expectations.
Despite raising the full-year adjusted revenue guidance, Ahuja didn't raise EBITDA guidance. "We plan to use our momentum in delivering growth at scale to reinvest back into the business as we execute on our long-term opportunities of omni-channel financial services and international," she said during Square's first-quarter earnings call. That strategy is consistent with how Square's former CFO, Sarah Friar, balanced investment and EBITDA growth. Investors shouldn't be concerned about lower EBITDA margin.
What's driving growth at Square?
Beyond Square's disappointing second-quarter outlook, investors expressed concern about Square's gross payment volume. GPV in the first quarter was $22.6 billion, but analysts were expecting $22.8 billion.
However, payment volume isn't the only thing driving revenue growth at Square. In her decision to raise guidance for the full year, Ahuja cited "outperformance in Cash App as well as continued strength across our seller business."
Cash App volume increased 2.5 times year over year. That number includes peer-to-peer payments as well as monetized Cash Card and Cash for Business transactions. Cash App's user base is growing at more than 100% year over year, and volume is increasing even faster as users become more engaged. Cash App volume isn't included in Square's gross payment volume.
While Cash App's engagement continues to grow, management isn't particularly concerned with monetization at this point. "The hard part is the engagement, and our team is nailing that," Ahuja said. "So as we launch more features, as we launch more services, as we grow daily utility, we believe monetization will follow."
The company's seller business appears healthy as well, and its ecosystem strategy is attracting higher-value customers. The company's focus on specific verticals and omnichannel retail have enabled it to grow payment volume from larger sellers (those generating over $500,000 in GPV per year) -- more than 50% year over year in the first quarter. That's nearly double its overall pace.
Continued improvements in the ecosystem will help Square attract more high-value customers with relatively high payment volume. Further, it gives the company more ways to monetize its merchants than through payments.
While Square's second-quarter outlook was disappointing, the long-term outlook for the company still looks good for investors.
https://finance.yahoo.com/news/square-investors-shouldn-apos-t-131800522.html