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>>> Israeli Startup Otonomo Nearing Merger With Software SPAC
Bloomberg
By Gillian Tan, David Welch, and Edward Ludlow
January 29, 2021
https://www.bloomberg.com/news/articles/2021-01-29/israeli-startup-otonomo-said-nearing-merger-with-software-spac?srnd=premium
Platform is fueled by data from more than 22 million vehicles
Otonomo’s earlier investors include Bessemer, Avis, Maniv
Otonomo, an Israeli startup that operates a data platform linked to millions of connected cars, is in talks to go public through a merger with Software Acquisition Group Inc. II, according to a person with knowledge of the matter.
The special purpose acquisition company is in talks to raise new equity to support a transaction that could be announced as soon as next week, said the person, who requested anonymity because the information isn’t public. The deal size couldn’t immediately be learned and it’s possible that, as with any deal that isn’t finalized, talks could collapse.
A representative for Software Acquisition Group declined to comment. Representatives for Otonomo didn’t immediately respond to requests for comment.
The SPAC’s shares rose 18% in after-hours trading on Friday.
Otonomo, led by Chief Executive Officer and founder Ben Volkow, takes over 4 billion data points per day from more than 22 million connected vehicles, according to its website.
The data is used for emergency services, mapping, parking and predictive maintenance, and partners include BMW AG, Daimler AG, Mitsubishi Motors Corp. and Mercedes-Benz.
The company last year raised fresh capital from investors including SK Holdings Co., Avis Budget Group, Maniv Mobility, Alliance Ventures and Bessemer Venture Partners. It was valued at about $465 million after that funding round, PitchBook data shows.
Software Acquisition Group, led by CEO Jonathan Huberman, raised $172.5 million in a September initial public offering and said at the time that it intends to focus its search on software companies.
Huberman’s first SPAC in October merged with CuriosityStream Inc., a media company that specializes in documentaries, among other features.
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BioCatch (private) - >>> The Leader in AI-Driven Behavioral Biometrics
https://www.biocatch.com/company/our-story
BioCatch was founded in 2011 by experts in neural science, artificial intelligence (AI), machine learning and cyberterrorism. The newly-founded company had a significant mission: to address next-generation digital identity challenges by focusing on online user behavior rather than static authentication measures, like passwords or endpoint security. They discovered an untapped goldmine.
Powerful behavioral insights — gleaned from the analysis of more than 2,000 physical and cognitive behavioral parameters — were able to support different use cases across the digital identity lifecycle. The technology enabled the holy grail of the modern digital era — seamless and secure online experiences. Behavioral biometrics, a technology used to identify people based on their behavioral parameters, was born.
BioCatch founder Avi Turgeman began pursuing a theory that people interact with machines in unique, measurable ways while serving in military intelligence. Drawing on years of experience exploring white-hat hacking, system vulnerability management and cyberterrorist operations, Turgeman turned his attention to online fraudsters and their identifiable signatures, co-founding BioCatch with Benny Rosenbaum.
In developing their AI-driven platform to passively identify both human and non-human behaviors online, BioCatch upended the paradigm of having to choose between security and convenience. Today, the company continues its commitment to innovation through an unparalleled IP portfolio of more than 60 granted or pending patents.
The BioCatch platform is deployed by major banks and other global enterprises to help manage their digital identity challenges. The technology prevents new account fraud, authenticates online users, prevents account takeover fraud and detects vishing scams, generating impressive returns on investment that come from catching more fraud as well as reducing false positives and unnecessary escalations.
BioCatch has been recognized for its industry leadership and cutting-edge approach to behavioral biometrics and digital identity in the CB Insights AI 100, One World Identity Leading Innovators in Identity, Deloitte Technology Fast 500, Florin Awards for Best Innovation in Securing Transactions and more.
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>>> SolarEdge Technologies (SEDG) makes power optimizers and inverters that help lower the cost of energy produced by solar panels. Sales of the company's products have been growing at a brisk pace, which will likely continue given the anticipated accelerating growth rate for solar. With costs of panels and battery storage coming down, industry watchers forecast that solar installations will quicken from an average of 10 GW per year in the 2019-2022 timeframe to 18-20 GW per year in between 2023 and 2030. With a cash-rich balance sheet, SolarEdge has the financial flexibility to continue expanding so that it can stay ahead of the technological curve and capture a sizable portion of this growth. <<<
https://www.fool.com/investing/2020/12/06/got-5000-here-are-5-energy-stocks-to-buy-and-hold/
>>> Israeli scientist uses microbubbles to explode cancer cells
Low-frequency ultrasound bursts microscopic bubbles injected into tumors; explosion kills the majority of the surrounding cancer cells.
By Naama Barak
AUGUST 9, 2020
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157554495
An international team of researchers led by an Israeli scientist has developed a noninvasive technology to kill breast cancer cells, an innovation that in the future could perhaps also be used to treat diseases such as brain cancer, Alzheimer’s and Parkinson’s.
The groundbreaking technique, developed by Tel Aviv University’s Tali Ilovitsh during her post-doctorate period at Stanford University, uses low-frequency ultrasound to burst microscopic tumor-targeted bubbles. Her research was recently published in the journal Proceedings of the National Academy of Sciences.
“Microbubbles are microscopic bubbles filled with gas, with a diameter as small as one-tenth of a blood vessel. At certain frequencies and pressures, soundwaves cause microbubbles to act like balloons: microbubbles expand and shrink periodically, and thus allow an increased transfer of substances from the blood vessel to the surrounding tissue,” Ilovitsh explained.
“We discovered that using lower frequencies than those applied before causes microbubbles to expand drastically until they explode. We understood that this discovery can be used as a tumor-treatment platform and started injecting microbubbles into tumors directly.”
Two-pronged approach
The research team injected microbubbles into tumors in engineered mice. The microbubbles were tumor-targeted, meaning that they attached to the tumor cells’ membranes at the moment of explosion.
“Around 80 percent of tumor cells were killed in the explosion, which is already positive,” Ilovitsh says. “The targeted treatment, which is safe and cheap, managed to destroy most of the tumor.”
And yet, to prevent the cancer from spreading, the researchers needed to destroy every cancer cell.
“That is why we injected an immunotherapeutic gene alongside the microbubbles, which acts as a Trojan horse and signals the immune system to attack the cell,” Ilovitsh said.
This gene that alerts the immune system to attack normally cannot enter cancer cells. Introduced by the exploding microbubbles, it managed to enter the cells that were not killed by the explosion and signal to the body that they were cancerous.
“The cancer cells were hit by the explosion, and through the holes that were created the gene we inserted into the microbubbles was transferred inside. Cancer cells that managed to heal and close themselves absorbed the gene that makes them produce a substance alerting the immune system to attack the cell,” Ilovitsh explained.
“In fact, our model mice had tumors on both sides of the body. Despite the fact that we injected microbubbles only to the tumor on one side, the immune system attacked the other side as well,” she relates.
Ilovitsh intends to use the technology that she developed as a noninvasive treatment for brain-damaging diseases such as Alzheimer’s, Parkinson’s and brain tumors.
“The blood-brain barrier does not allow medications to pass through, but microbubbles can expand and enable a temporary opening of the barrier, thus letting the treatment reach its target without requiring an operation,” she said.
https://www.israel21c.org/israeli-scientist-uses-microbubbles-to-explode-cancer-cells/
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Ormat - >>> Worried About Another Coronavirus Sell-Off? Buy These 3 Safe Stocks
The pandemic is back in the headlines. Here's how to protect your portfolio.
MarketWatch
John Bromels, Scott Levine, And Lee Samaha
Oct 11, 2020
https://www.fool.com/investing/2020/10/11/worried-about-another-coronavirus-sell-off-buy-the/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
Last week ended with the concerning news that President Donald Trump had tested positive for COVID-19. This week began with the grim news that the U.S. had hit its highest daily coronavirus infection rate in two months.
As case numbers across the country continue to rise, investors are smart to be concerned. For those who are worried about how a second coronavirus sell-off might impact their savings, we asked three of our Motley Fool contributors which safe stocks they'd recommend. They came back with Hormel Foods (NYSE:HRL), Brookfield Infrastructure (NYSE:BIP) (NYSE:BIPC), and Ormat Technologies (NYSE:ORA). Here's why.
A conservatively run food company
Lee Samaha (Hormel Foods): This food company is definitely not your average publicly listed corporation. In fact, it appears to be run more like a private company. The Hormel Foundation -- a nonprofit organization set up by Hormel Foods founder George Hormel and his son -- owns 48% of the stock, with institutional shareholders holding 43%. The aims of the foundation are to preserve the company's independence, support the local community, and provide for the welfare of the heirs.
That means the consumer-staples company tends to be conservatively run, with very little debt. And it has a progressive dividend policy: Hormel is a Dividend Aristocrat, having raised its dividend for 54 consecutive years. However, the "safe stock" aspect to its attractiveness doesn't stop at the way the company is run, because Hormel's end markets are relatively stable too.
Slightly over half of its sales go to the U.S. retail market, with 31% to the U.S. food-service market, 10% to U.S. delis, and 7% to the international market. It's a good mix and has given the company resiliency during the COVID-19 crisis. For example, in Hormel's fiscal third quarter, strong growth in retail sales more than offset declines in its food-service sales (as restaurants were forced to close because of COVID-19), leading to 2.2% organic sales growth.
Thinking longer-term, Hormel is hoping its food-service sales will improve as the economy opens up again. In addition, management has made significant acquisitions and capital investments in recent years in order to boost growth. Meanwhile, the long-term case for the stock as a play on demand for protein remains: Pork products (including SPAM, Hormel brand, and Black Label) contribute 50%-55% of sales; turkey (Jennie-O) 18%-22%; non-meat (Skippy) 16%-18%; beef 8%-10%; and chicken and other products 2%-4%.
All told, Hormel is a useful stock for risk-averse investors looking for a dividend yield of nearly 2%.
Infrastructure: The gift that keeps on giving
John Bromels (Brookfield Infrastructure): Generally speaking, the more essential a business is, the "safer" its stock is likely to be. Hormel, above, was a good example: Regardless of what the stock market or the economy are doing, people have to eat. People also have to heat their homes in the winter, keep the lights on, and -- especially during a quarantine -- stay connected with the outside world. And Brookfield Infrastructure helps people around the globe do just that.
Brookfield Infrastructure is part of the Brookfield Asset Management (NYSE:BAM) family, and focuses on four areas: utilities, energy, data infrastructure, and transportation. It's no surprise that the first three of those four areas have not only managed to perform well during the pandemic, they have actually outperformed. The funds from operations (FFO) generated by those three businesses in the first half of 2020 were 8.3% higher than in the first half of 2019.
As you can probably guess, the company's transportation segment -- which owns toll roads, ports, and rail lines -- didn't do so well, as global travel ground to a halt during the height of the pandemic. Management expects this side of the business to recover in 2021. Investors can hop along for the ride by buying the company's shares of stock, with the ticker symbol BIPC, or units of its master limited partnership (MLP), with the BIP ticker. Either one will not only add some safety to your portfolio, but also provide a healthy yield of about 4.9%.
Sleep soundly with this low-risk energy stock
Scott Levine (Ormat Technologies): As global coronavirus cases rise dramatically and leaders implement lockdowns to curb the spread of the pandemic, it's unsurprising that investors are having flashbacks to the volatility which rocked the market last spring. Likewise, the interest in conservative stocks is equally understandable, as investors look to fortify their portfolios against future market turmoil.
For those who find themselves in this situation -- on the lookout for safer stocks -- Ormat Technologies is a name that's well worth considering. A leading global provider of geothermal solutions, Ormat has clear foresight into its future finances, as it often signs long-term power purchase agreements with customers.
In addition to geothermal energy, Ormat is also committed to expanding into the energy-storage market. Last April, for example, Ormat commenced operation of a 10-megawatt (MW) storage facility, Rabbit Hill, in Texas. More recently, in July, Ormat announced the acquisition of its first battery-energy storage facility, Pomona, in California.
While the company's past performance doesn't guarantee future performance, it's worth noting that over the past five years Ormat has provided investors with a total return of 97%, outpacing the 72% gain in the S&P 500.
In terms of its financials, Ormat has succeeded in steadily growing revenue over the past five years -- a period during which it has also increased EBITDA (earnings before interest, taxes, depreciation, and amortization) and operational cash flow:
Like many businesses, Ormat expects the impact of COVID-19 to adversely affect its top line this year. While its 2020 revenue forecast of approximately $718 million (which would be a year-over-year decline of about 4%) may give some investors pause, it's hardly an indication that the company is in peril. In fact, on Ormat's recent Q2 2020 earnings conference call, CEO Doron Blachar stated that the company is "on track to meet [its] 2022 megawatt growth goals" and it's "laying the foundation to enable us to continue our growth path in 2023 and beyond."
Besides its steady revenue and cash-flow generation, the company's circumspect approach to the dividend should appeal to cautious investors. While the modest forward dividend yield of 0.64% may not be much to write home about, the stock's average annual payout ratio over the past five years -- 19.3% -- suggests that management isn't willing to jeopardize the company's financial health in order to attract dividend investors.
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>>> Gamida Cell (GMDA) Presents Analysis of Observational Data Demonstrating the Impact of Donor Age in Hematopoietic Stem Cell Transplant Outcomes at the Virtual Cord Blood Connect Meeting
September 10, 2020
https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-presents-analysis-observational-data
— Study shows younger donor age is associated with improved outcomes following bone marrow transplant —
BOSTON--(BUSINESS WIRE)--Sep. 10, 2020-- Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced data from an observational study demonstrating that younger donor age is associated with more rapid time to neutrophil engraftment and increased overall survival in patients who received hematopoietic stem cell transplant (HSCT, or bone marrow transplant) for the treatment of hematological malignancies. These data are being presented at the Cord Blood Connect Meeting, which is taking place virtually today and on September 17.
The study is the result of a research agreement between Gamida Cell and the CIBMTR® (Center for International Blood and Marrow Transplant Research®) designed to collect and analyze health outcomes data in patients with hematologic malignancies who receive a hematopoietic stem cell transplant or cellular therapy infusion, including bone marrow transplant graft from various donor sources. The study evaluated clinical outcomes for 660 patients in the CIBMTR registry who underwent a bone marrow transplant with a matched unrelated, mismatched unrelated or haploidentical graft source contemporaneous to the Phase 3 study of omidubicel, Gamida Cell’s investigational advanced cell therapy in development as a treatment option for patients in need of a bone marrow transplant. Key clinical outcomes, including time to neutrophil engraftment and overall survival, were improved for patients with donors under the age of 30.
“As new graft options evolve for bone marrow transplant, and we as a field learn more about the long-term patient outcomes of these graft options, the selection algorithms that are used to match patients with donors must also evolve to take into account the most current clinical data,” said Ronit Simantov, M.D., chief medical officer at Gamida Cell. “These data indicate that donor age is a factor in clinical outcomes and that donor age should be considered when matching patients with a graft source.”
In May, Gamida Cell reported that its Phase 3 study of omidubicel achieved its primary endpoint, demonstrating a highly statistically significant reduction (p < 0.001) in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Gamida Cell expects to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter of 2020.
“This analysis reinforces the importance of considering donor age when selecting a bone marrow graft source for patients, as donors aged 30 or younger resulted in improved overall survival,” said Julian Adams, Ph.D., chief executive officer at Gamida Cell. “As we look toward our anticipated regulatory submission of omidubicel to the FDA and potential approval, given that omidubicel is derived from cord blood, we believe these findings could potentially have future implications for considering omidubicel for any patient who does not have an available related or unrelated donor of suitable age.”
More Details About the Study
This observational study utilizes data from the CIBMTR® registry to analyze long-term safety and efficacy data for patients with hematologic malignancies who underwent a bone marrow transplant with a matched unrelated, mismatched unrelated or haploidentical graft source. The criteria for inclusion of patients and the outcomes evaluated in the analyses were consistent with those in the Phase 3 study of omidubicel. The median donor age was 30 (range 2-74) years.
Statistical analyses, performed by Gamida Cell, compared important clinical outcomes for patients with donors ≤ 30 years old (n=334) to patients with donors > 30 years of age (n=326). Patient demographics were well-balanced across the two donor age groups. The study demonstrated that neutrophil recovery was more rapid in patients with donors ≤ 30 years old (p = 0.013). Additionally, patients with donors ≤ 30 years of age showed improved overall survival at one year (p = 0.016).
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230 and NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
About the CIBMTR
The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW). The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide to increase survival and enrich quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a network of more than 300 transplant centers, and one of the largest databases worldwide for clinical outcomes of cellular therapy, and a biorepository with tissue samples.
For more information on the CIBMTR, please visit www.cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or Twitter at @CIBMTR.
About the National Marrow Donor Program/Be The Match
The National Marrow Donor Program® (NMDP)/Be The Match® is the global leader in providing a cure to patients with life-threatening blood and marrow cancers like leukemia and lymphoma, as well as other diseases. The NMDP/Be The Match manages the world’s largest registry of potential blood stem cell donors and cord blood units, connects patients to their donor match for a life-saving marrow or umbilical cord blood transplant and educates health care professionals and patients. In 2016, the NMDP/Be The Match established Be The Match BioTherapies® to accelerate patient access to life-saving therapies, by providing proven services and support to companies developing and delivering cell and gene therapies.
Learn more at BeTheMatchClinical.org.
About the Medical College of Wisconsin
With a history dating back to 1893, The Medical College of Wisconsin (MCW) is dedicated to leadership and excellence in education, patient care, research and community engagement. More than 1,200 students are enrolled in MCW’s medical school and graduate school programs in Milwaukee, Green Bay, and Central Wisconsin in 2016. MCW’s School of Pharmacy opened in 2017. A major national research center, MCW is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In FY2016, faculty received more than $184 million in external support for research, teaching, training and related purposes. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, MCW faculty direct or collaborate on more than 3,100 research studies, including clinical trials. Additionally, more than 1,500 physicians provide care in virtually every specialty of medicine for more than 525,000 patients annually.
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>>> Ellomay Capital Ltd. (ELLO), together with its subsidiaries, produces and sells renewable and clean energy in Israel, Spain, and the Netherlands. The company owns five photovoltaic (PV) plants comprising four PV plants in Spain with an aggregate installed capacity of approximately 7.9 MWp; and one PV plant in Israel with an installed capacity of approximately 9 MWp. It also operates a dual-fuel power plant with an installed capacity of approximately 860 MWp in the vicinity of Ashkelon, Israel; and engages in the construction of a 156 MW pumped storage hydro power plant in the Manara Cliff, Israel. In addition, the company develops anaerobic digestion plants with a green gas production capacity of approximately 375 Nm3/h in Goor and 475 Nm3/h in Oude Tonge, the Netherlands. Further, it is involved in the construction of a PV plant with a peak capacity of 300 MW in the municipality of Talaván, Cáceres, Spain. The company was formerly known as NUR Macroprinters Ltd. and changed its name to Ellomay Capital Ltd. in April 2008. Ellomay Capital Ltd. was founded in 1987 and is based in Tel Aviv, Israel. <<<
Ellomay Capital – A 52-Week High
A renewable energy and power generator and developer in Europe and Israel saw its stock reach its new 52-week high in August. According to Investors Observer, Ellomay Capital Ltd (NYSEAMERICAN:ELLO) is near the top in its sector. It gained a ranking of 73, which implies it scores higher than 73% of stocks. <<<
https://www.yahoo.com/news/whats-solar-energy-rundown-6-171355260.html
>>> SolarEdge Technologies, Inc. (SEDG), together with its subsidiaries, designs, develops, and sells direct current (DC) optimized inverter systems for solar photovoltaic (PV) installations worldwide. Its SolarEdge system consists of power optimizers, inverters, communication and smart energy management solutions, and a cloud based monitoring platform. The company's products are used in a range of solar market segments, such as residential, commercial, and small utility-scale solar installations. It also provides pre-sales support, ongoing trainings, and technical support and after installation services; and lithium-ion cells, batteries, and energy storage solutions for various industries, including energy storage systems, residential and commercial solar systems, uninterruptible power supplies, electric vehicles, aerospace, marine, and others. The company sells its products to the providers of solar PV systems; and solar installers and distributors, electrical equipment wholesalers, and PV module manufacturers, as well as engineering, procurement, and construction firms. SolarEdge Technologies, Inc. was founded in 2006 and is headquartered in Herzliya, Israel.
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>>> Nano Dimension Ltd. (NNDM), together with its subsidiaries, provides additive electronics in Israel and internationally. Its flagship product is the proprietary DragonFly lights-out digital manufacturing system, a precision system that produces professional multilayer circuit-boards, radio frequency antennas, sensors, conductive geometries, and molded connected devices for prototyping through custom additive manufacturing. The company also provides nanotechnology based conductive and dielectric inks; and DragonFly and Switch software to manage the design file and printing process. It markets and sells products and services to companies that develop products with electronic components, including companies in the defense, automotive, consumer electronics, semiconductor, aerospace, and medical industries, as well as research institutes. The company was founded in 2012 and is headquartered in Ness Ziona, Israel.
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>>> Gamida Cell Ltd. (GMDA), a clinical stage biopharmaceutical company, focuses on developing cell therapies to cure cancer, and rare and serious hematologic diseases. The company's lead product candidate is NiCord, a nicotinamide (NAM)-expanded cord blood cell therapy that is in Phase III studies in patients with high-risk hematologic malignancies, as well as in Phase I/II studies in patients with severe aplastic anemia. It is also developing NAM-NK, an innate immunotherapy, which is in Phase I studies for the treatment of relapsed or refractory non-Hodgkin lymphoma and multiple myeloma. The company was founded in 1998 and is headquartered in Jerusalem, Israel.
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>>> BiondVax Pharmaceuticals Ltd. (BVXV), a clinical stage biopharmaceutical company, focuses on developing and commercializing immunomodulation therapies for infectious diseases primarily in Israel. Its product candidate is M-001, a synthetic peptide-based protein, which is in Phase III clinical trials that is used for treating seasonal and pandemic strains of the influenza virus. The company was founded in 2003 and is headquartered in Jerusalem, Israel. <<<
>>> Preliminary Data from NIH/NIAID-sponsored Phase 2 Clinical Trial of BiondVax’s M-001 Universal Influenza Vaccine Candidate Validates Results of Previous Clinical Trials
https://www.biondvax.com/2020/02/preliminary-data-from-nih-niaid-sponsored-phase-2-clinical-trial-of-biondvaxs-m-001-universal-influenza-vaccine-candidate-validates-results-of-previous-clinical-trials/
Data published on Clinicaltrials.gov
Jerusalem, Israel – February 5, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that preliminary data from the Phase 2 clinical trial of BiondVax’s M-001 universal influenza vaccine candidate have been published. The trial was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The primary objectives of the trial were to assess safety and T-cell responses to M-001. The data, which are consistent with results of previous clinical trials of M-001, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, “We are grateful for the opportunity to collaborate with NIAID and thank them for their professionalism and partnership. This was M-001’s first clinical trial in the US under the FDA’s Investigational New Drug program (IND). Data from this Phase 2 trial confirm results from six previously completed clinical trials of M-001. BiondVax’s universal flu vaccine candidate was found to be safe, well tolerated and induce statistically significant cellular immune responses.”
The Phase 2 clinical trial was conducted by NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The trial enrolled 120 participants aged 18 to 49 years at the following VTEU sites: Baylor College of Medicine in Houston, Texas; the University of Iowa in Iowa City, Iowa; and Cincinnati Children’s Hospital Medical Center in Cincinnati, Ohio. Individuals were randomly assigned to receive either two doses of M-001 or two doses of a placebo, with the doses spaced three weeks apart. Later, near the beginning of the 2018/19 flu season, all participants were immunized with a currently marketed quadrivalent seasonal influenza vaccine. Laboratory analyses of vaccine immunogenicity were performed at the Baylor College of Medicine and Saint Louis University (St. Louis, Missouri) VTEU sites and at BiondVax Pharmaceuticals.
The published data are available at
https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was supported through NIAID awards #HHSN272201300016I, HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
In parallel, BiondVax’s pivotal, clinical efficacy, Phase 3 trial in Europe, involving 12,463 older adults, is ongoing. Results of that trial are expected by the end of 2020.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.
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>>> Israel Tech ETF Celebrates A Milestone In Style
Benzinga
January 22, 2020
The BlueStar Israel Technology ETF (NYSE: ITEQ), the first exchange traded fund to one of the world's best ex-Asia, ex-U.S. technology scenes, is celebrating an important milestone, having recently topped $100 million in assets under management.
Crossing that much ballyhooed asset level is confirmation for ITEQ, which debuted in 2015. It's confirmation that investors are responding to the investment thesis offered by Israel's burgeoning technology landscape, one widely supported by the emergence of cybersecurity as a significant driver of technology sector performance.
ITEQ follows the BlueStar Israel Global Technology Index. That benchmark “includes Israeli companies, irrespective of listing venue, operating in industries ranging from information technology to biotechnology, defense and security technology, and clean energy technology,” according to BlueStar.
Why It's Important
Crossing assets under management milestones is nice for ETFs, particularly those issued by smaller providers and those with refined investment concepts. What should be important to advisors and investors is the credibility and potential of the fund's investment thesis.
ITEQ has plenty of that. Over the past year, ITEQ is higher by almost 41%, making the 14.90% returned by the MSCI Israel Index over that span seem paltry by comparison.
ITEQ's 12-month run also dispels the notion that there haven't been any ex-US developed market opportunities worth seizing. Speaking of ex-U.S. developed markets, ITEQ is beating the MSCI EAFE Index, of which Israel is a small part, by a margin of more than 3-to-1 over the past year.
Importantly, ITEQ is bringing some flair to the $100 million, having surged 8.51% since the start of this year.
What's Next
Betting against ITEQ would appear premature at this point, if not ill-fated. With cloud, cybersecurity and semiconductor stocks expected to perform well this year, ITEQ is well-positioned to benefit from those trends with a more than 60% weight to software and chip makers.
Then there is consolidation, ITEQ is chock full of would-be buyers and potential acquisition targets at a time of expected consolidation in Israel's technology sector.
“The past decade has been very good to Israel's high-tech industry, which saw 1,210 mega-deals amounting to 385 billion shekels ($111 billion), high-tech industry data research firm IVC-Meitar said this week,” reports Israel Hayom.
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Israel Aerospace Industries -
https://www.ainonline.com/aviation-news/aerospace/2020-04-27/uv-c-light-system-eliminates-covid-19-aircraft-cabins
>>> A UV-C light system will soon be available for disinfecting aircraft interiors, according to Israel Aerospace Industries (IAI), which has been fast-tracking deployment of the technology to combat Covid-19 infection in hospitals. According to the company, the robot-based system is suitable for use in any size of aircraft, having already been tested in a widebody cargo airliner and a helicopter.
The equipment uses a 254-nanometer electromagnetic wave that is shorter than a visual wavelength and longer than an x-ray wavelength. Research has proven its ability to kill any germ or virus, IAI said.
In an aircraft, the robot can move between seats in straight lines and lights on electronically-controlled arms move across all exposed surfaces, such as seats and other cabin fittings. Unexposed surfaces beneath those items would still have to be manually cleaned with chemicals.
For an airliner, the 12-inch-wide robot can move up and down standard aisles between seats. In a smaller aircraft, such as a business jet, one or more stationary units, which were originally designed for hospital rooms, would be deployed.
According to an IAI spokesman, it would take between 30 and 40 minutes to disinfect a widebody aircraft. He said the company remains “a few months” away from being able to deliver the equipment to the aviation sector and is currently exploring what regulatory requirements would apply to its use.
IAI expects to market the system to aircraft operators and maintenance, repair, and overhaul providers. It has yet to announce pricing for the equipment. The company started work on the technology soon after the outbreak of the Covid-19 pandemic. In March, it demonstrated the system in two Israeli hospitals.
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NSO Group - >>> Inside the secretive Israeli spyware startup scene, where the notorious NSO Group has spawned a web of companies that hack into devices
by Becky Peterson
Sept. 6, 2019
Business Insider
https://markets.businessinsider.com/news/stocks/israel-offensive-cybersecurity-world-funded-by-nso-group-2019-9-1028504908
The Israeli cybersecurity firm NSO Group has been accused of selling sophisticated digital surveillance technology to Saudi Arabia and other countries that have allegedly used it to attack dissidents and journalists.
Despite the controversy, the company is extremely profitable.
NSO Group's founders and alumni have spawned a web of more than a dozen similar startups, many of which operate in secret, that sell attacks against routers, computers, smart speakers, and other digital devices.
Spend some time in the shadowy world of companies that sell "offensive cyber capabilities" — secret tools that let you hack into phones, computers, and other digital devices to spy on their users — and one outfit looms large.
It sits at the center of a bustling but discreet ecosystem of startups based in Israel that specialize in bypassing, undermining, and counteracting the security features of our digital environment, granting clients in some cases nearly unrestricted access to the texts, calls, and conversations of almost anyone they choose.
There are more than a dozen such companies in Israel, according to investors and employees in the space, though many of them are operated in stealth by founders who have left miraculously little trace of their existence on the internet.
And chief among them is NSO Group, the largest company at the cutting edge of offensive cybersecurity.
NSO Group's founders say its technology, which focuses on compromising smartphones, is designed with the noble purpose of helping governments combat terrorism and crime.
But the startup became the target of international outrage this year following allegations that its software, called Pegasus, was used by a rogues' gallery of countries including Saudi Arabia, the United Arab Emirates, and Mexico to attack reporters, dissidents, and political targets.
But as a startup, NSO Group is a runaway a success. It has been valued at $1 billion — a fortune in the Israeli tech environment, where the most successful companies get acquired for less than $500 million. And it's wildly profitable, Business Insider can report: It made $125 million in profit last year.
All that money has spawned a new web of highly specialized startups funded by NSO Group's founders and investors, known in tech circles as "the NSO Mafia," which sell niche tools to penetrate WiFi routers, home speakers, and other devices.
These companies often describe their wares as "lawful interception" or "intelligence" tools, though this hardly tells the full story. They all sell tools that take devices and turn them against their users to secretly spy without leaving a trace.
Whatever you call this technology, business is booming. Governments and law enforcement agencies around the world are paying millions of dollars. And startups both inside of Israel and out are ready to sell.
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>>> Else Nutrition Holdings Inc. Announces Dr. Jon A. Vanderhoof – Former Vice President, Global Medical Affairs at Mead Johnson Nutrition
Appointed to Advisory Board
October 23, 2019
https://finance.yahoo.com/news/else-nutrition-holdings-inc-announces-100000068.html
VANCOUVER, BC / ACCESSWIRE / October 23, 2019 / ELSE NUTRITION HOLDINGS INC. (TSX-V: BABY) (OTCQB: BABYF) ("Else" or the "Company"), a company focused on developing and marketing a real alternative to dairy-based infant nutrition, is pleased to announce that effective October 1, 2019, Dr. Jon A. Vanderhoof has been appointed to the Advisory Board of Else Nutrition GH Ltd., the Company's operating company which is located in Israel..
"We are extremely pleased to add Dr. Vanderhoof's experience and insights to the Else Nutrition Team. His extensive expertise, particularly in children's health and nutrition will be of tremendous benefit to our company and our customers," said Hamutal Yitzhak, CEO of Else Nutrition. She added, "His passion for improving children's health perfectly complements our vision as we move our product towards commercialization."
"The opportunity to join Else Nutrition in their vision to create clean-label, and nutritious plant-based alternatives for infants, toddlers and children is extremely exciting. Many of today's parents are demanding all-natural, plant-based solutions free of antibiotics, GMO, and hormones, for their children's nutrition. Careful formulation and scientific and clinical evaluation of such products are essential to ensure their safety and efficacy," said Dr. Vanderhoof. He added, "Else Nutrition's breakthrough formulation will provide the safety and assurance parents need to optimize their child's health and well-being, and I look forward to helping extend this impact."
Dr. Vanderhoof is a pediatric gastroenterologist in at Boston Children's Hospital, Senior Lecturer in Pediatrics at the Harvard Medical School, and Professor Emeritus of Pediatrics at the University of Nebraska College of Medicine. He was the first Chief of Pediatric Gastroenterology and Nutrition at the University of Nebraska Medical Center and served as Chair of Pediatrics at Creighton University. Dr. Vanderhoof was Vice President, Global Medical Affairs and Chief Medical Officer, for Mead Johnson Nutrition from 2002 to 2011. Dr. Vanderhoof received his medical degree from the University of Nebraska College of Medicine, completed his fellowship in Pediatric Gastroenterology and Nutrition at the University of California at Los Angeles, and has been in practice for over 20 years.
Dr. Vanderhoof has published over 200 peer-reviewed papers, reviews and literature in various areas of pediatric gastroenterology and nutrition. He served as President of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and on the editorial boards of numerous scientific and clinical journals. He has lectured widely both nationally and internationally on a variety of issues related to all areas of pediatric gastrointestinal disease and nutrition. Dr. Vanderhoof received the Shwachman Award in 2001 from the North American Society of Pediatric Gastroenterology and Nutrition, the highest award given in the field of Pediatric Gastroenterology in North America.
About Else Nutrition Holdings Inc.
The Company is a food and nutrition company focused on research, development, manufacturing, marketing, sale and/or license of innovative plant-based food and nutrition products to the infant, toddler, children and adult markets. Its revolutionary 100% plant-based non-soy alternative to dairy-based baby formula received the "Best Health and Diet Solutions" award in the Global Food Innovation Summit in Milan in May 2017. For more information, visit: elsenutrition.com.
For more information, contact:
Hamutal Yitzhak, CEO, Co-Founder & Director
ELSE Nutrition Holdings Inc.
E:hamutaly@elsenutrition.com
P: +972(0)52-447-9931
TSX Venture Exchange
Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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>>> Else Nutrition Receives Favorable Regulatory Assessment Ahead of U.S. Market Launch
ACCESSWIRE
December 16, 2019
https://finance.yahoo.com/news/else-nutrition-receives-favorable-regulatory-110000738.html
VANCOUVER, BRITISH COLUMBIA / ACCESSWIRE / December 16, 2019 / ELSE NUTRITION HOLDINGS INC. (TSX-V: BABY, OTCQB: BABYF) ("Else" or the "Company"), a developer of plant-based alternatives to dairy-based baby nutrition, announces that it has received a favorable regulatory assessment of its toddler formula ingredients from EAS Consulting Group, LLC, which conducted a preliminary review of the Else formula in view of the FDA (Food and Drug Administration) requirements.
With vast, global expertise in regulatory approvals, and specialty in FDA requirements, EAS has unique experience and capability pertaining to the introduction of food, drinks and new infant formulas.
"The EAS Infant Formula Team has confirmed that Else toddler formula intended to be marketed in the U.S. meets the regulatory requirements for general food as required for a toddler formula," stated Dr. Fabiana Bar-Yoseph, Else's Director of Clinical Development, Regulatory and Scientific Affairs. She added, "This regulatory validation marks a significant step as we look to bring a nutritious, plant-based toddler formula to the U.S. market."
Else Nutrition's 100% plant-based toddler formula is set to launch in the U.S. market in the second quarter of 2020.
About Else Nutrition Holdings Inc.
The Company is a food and nutrition company focused on research, development, manufacturing, marketing, sale and/or license of innovative plant-based food and nutrition products to the infant, toddler, children and adult markets. Its revolutionary 100% plant-based non-soy alternative to dairy-based baby formula received the "Best Health and Diet Solutions" award in the Global Food Innovation Summit in Milan in May 2017. For more information, visit: elsenutrition.com.
About EAS Consulting Group, LLC (EAS)
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North and South America, Europe, and various Pacific Rim counties, EAS Consulting Group is a sought-after expert in regulatory matters, assisting firms with highly technical submissions such as GRAS, DMF, NDI, ANDA, 510(k) and others, as well as the development of quality systems, label reviews, structure-function claims, GMP audits, and US Agent assistance and more. EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters.
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>>> Will an Israeli plant-based infant formula go mainstream?
‘It is a near perfect alternative to breastmilk,’ says Else Nutrition’s (BABYF) cofounder about the almond-buckwheat product heading to market in 2020.
Israel 21 c
By Lauren Izso
NOVEMBER 24, 2019
https://www.israel21c.org/will-an-israeli-plant-based-infant-formula-go-mainstream/
Providing an infant with proper nutrition seems like a no-brainer: Breastmilk or cow’s milk. But what if a child is allergic? Lactose intolerant? Until now, there hasn’t been a good alternative.
Else Nutrition, a Tel Aviv-based company, hopes to solve this dilemma for infants and toddlers.
While Else was founded in May 2018, the product has been in research-and-development for five years. The company of only 10 employees has huge plans for expansion in the future.
Else Nutrition cofounder Hamutal Cohen Yitzhak. Photo: courtesy
Hamutal Cohen Yitzhak, one of the cofounders, says the plant-based formula composed of almond milk and buckwheat will launch on the market next year.
“It is a near perfect alternative to breastmilk,” she tells ISRAEL21c.
Yitzhak and the company’s other cofounders launched Else mainly out of their own pockets. They each have backgrounds in the infant nutrition industry in Israel. Yitzhak was previously Israel’s category manager for Similac infant formula at Abbott Labs.
Born out of a granddaughter’s need
The story begins with cofounder Uriel Kesler. His 10-month-old granddaughter was rejecting breastmilk and cow’s milk, and even a special hypoallergenic formula.
“She was allergic to everything the industry could offer her because she couldn’t consume milk or soy,” recalls Yitzhak.“She was vomiting up almost everything she was consuming, and she had respiratory issues as a result.”
At the time, Yitzhak and Kesler had been working together for nearly a decade developing baby snacks.
They began experimenting to find a solution for Kesler’s granddaughter, and quickly found substantial similarities in the makeup of almonds to breast glands. Once they gave the child almond milk, her health began to improve.
But almonds alone did not provide the balance of nutrients a toddler needs to develop properly.
“We had a significant gap in terms of proteins and carbohydrates. So, we searched for another plant that could bring the full amino acid profile of protein. And we found buckwheat,” Yitzhak explains.
“The combination allowed us to imitate breastmilk composition in terms of nutritional value.”
Vegan and healthful
While the main target market includes infants and toddlers with an intolerance to mainstream formulas, Else is “absolutely” an alternative for parents who choose a vegan lifestyle and want their babies to have a plant-based diet as well, Yitzhak says.
“’Vegan,’ however, is not a synonym for ‘healthy.’ You can have a vegan product that is intensely processed and that has many ingredients that are not good for you. Our product is plant-based, vegan and also extremely healthy and all natural,” she says.
“It will take time, but we are going to educate people about this.”
Childcare expert and daycare owner Hagit Miller tells ISRAEL21c that there is no perfect alternative to breastmilk.
“But for those who choose not to breastfeed [or cannot breastfeed], there must be an option that provides a complete proper nutritional diet” without supplements, Miller says.
Up until now, the alternatives have been far less than perfect.
“There is scientific data that proves that soymilk can damage the hormone system,” Yitzhak says.
Soymilk was once the number one formula replacement. Another company is trying to develop a similar product using rice but was unable to eliminate arsenic from the composition.
Coming to online stores first
Else Nutrition has spent the last five years developing and testing the product, and Yitzhak says it will hit online stores in North America in 2020, and a few months later in Europe.
The formula will cost around $27-$30 for 23 ounces of powder.
Yitzhak anticipates that Else eventually will be sold in health food stores, and even in supermarkets one day.
The plant-based baby formula already has claimed several awards including “Best health and diet solution” at the Global Food Innovation Summit in 2017 in Milan.
Else Nutrition was a finalist at the startup competition at FoodTechIL in September, and at the Foodbytes London pitch competition in November.
Recently, a group of Canadian investment brokers from Canaccord Genuity Corporation invested $5.7 million in Else Nutrition. As a result, the company is now listed on the Toronto Stock Exchange, one of the biggest in the world.
Now the company is focused on mass production in order to prepare for next year’s launch. According to Yitzhak, this is just the beginning.
“We hope to develop products based on this concept for the entire family from infants to the elderly.”
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>>> Israeli biotechs and Chinese biotechs are both problematic for investors—but for different reasons.
With Chinese biotechs, foreign investors’ main problem is that there they aren’t actual shareholders of the underlying company, so they have no BoD representation and they have insufficient legal protection from simple expropriation.
With Israeli biotechs, investors’ main problem is that the science is often dubious. Compared to the US, Israel does not have as well-established a biotech VC community, so Israeli companies that ought to be in the VC stage end up trading on the TASE or Nasdaq. <<<
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152790626
>>> CyberArk Software Ltd. (CYBR), together with its subsidiaries, provides software-based security solutions and services for organizations to safeguard and monitor their privileged accounts. The company's solutions include Core Privileged Access Security for risk-based credential security and session management with add-on options for least privilege server and domain controller protection; Application Access Manager for secrets management for applications, tools, containers, and DevOps; and Endpoint Privilege Manager for least privilege and credential theft protection for workstations. It also provides Sensitive Information Management solution; and software maintenance and support, and professional services. The company offers its products to financial services, manufacturing, insurance, healthcare, energy and utilities, transportation, retail, technology, and telecommunications industries, as well as government agencies through direct sales force, as well as distributors, systems integrators, value-added resellers, and managed security service providers. It operates in the United States, Europe, the Middle East, Africa, the Asia Pacific, Latin America, and Canada. CyberArk Software Ltd. was founded in 1999 and is headquartered in Petach Tikva, Israel.
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>>> Wix.com Ltd. (WIX) develops and markets an Internet service that allows users to create Web content in North America, Europe, Latin America, Asia, and internationally. The company offers Wix Editor, a drag-and-drop visual development and Website editing environment platform; Wix ADI that enables users to create a Website for their specific needs; and Wix Code to create Websites and Web applications. It also provides Ascend by Wix, which offers its users access to a suite of approximately 20 products or features enabling them to connect with their customers, automate their work, and grow their business; Wix Logo Maker that allows users to generate a logo using artificial intelligence; Wix Answers, a support infrastructure enabling its users to help their users across various channels; and Wix Payments, a payment platform, which helps its users receive payments from their users through their Wix Website. In addition, the company offers various vertical-specific applications that business owners use to operate various aspects of their business online. Further, it provides a range of complementary services, including App Market that offers its registered users the ability to install and uninstall a range of free and paid Web applications; Wix Arena, an online marketplace that brings users seeking help in creating and managing a Website, together with Web experts; and Wix App, a native mobile application, which enables users to manage their Websites and Wix operating systems. As of December 31, 2018, the company had approximately 142 million registered users and 3,983,415 premium subscriptions. Wix.com Ltd. has a strategic partnership with NTT Town Page Corporation. The company was formerly known as Wixpress Ltd. Wix.com Ltd. was founded in 2006 and is headquartered in Tel Aviv, Israel.
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>>> Mellanox Technologies, Ltd. (MLNX), a fabless semiconductor company, designs, manufactures, markets, and sells interconnect products and solutions. Its products facilitate data transmission between servers, storage systems, communications infrastructure equipment, and other embedded systems. The company offers InfiniBand solutions, including switch and gateway integrated circuits (ICs), adapter cards, cables, modules, and software, as well as switch, gateway, and long-haul systems; and Ethernet solutions, such as Ethernet switch products and Ethernet adapters for use in enterprise data center, high-performance computing, embedded environments, hyperscale, Web 2.0, and cloud data centers. It also provides adapters to server, storage, communications infrastructure, and embedded systems original equipment manufacturers (OEMs) as ICs or standard card form factors with PCI express interfaces; and switch ICs and systems to server, storage, communications infrastructure, and embedded systems OEMs to create switching equipment. In addition, the company supports server operating systems, including Linux, Windows, AIX, HPUX, Solaris, and VxWorks. It sells its products through its direct sales force, a network of sales representatives, and independent distributors. The company operates in the United States, China, Europe, rest of Americas, and rest of Asia. Mellanox Technologies, Ltd. was founded in 1999 and is headquartered in Sunnyvale, California.
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>>> Is NovoCure a Buy?
Investors in the cancer-focused medical device company have enjoyed strong returns already. Is it too late to hop on board?
Motley Fool
Brian Feroldi
Dec 24, 2018
https://www.fool.com/investing/2018/12/24/is-novocure-a-buy.aspx
Billions of dollars have been spent on research and development in the battle against cancer. Unfortunately, cancer still claims more than half a million lives in the U.S. alone each year.
Novocure (NASDAQ:NVCR) is on a mission to give patients with cancer a fighting chance. This innovative medical-device company is harnessing the power of physics to approach cancer treatment from a unique perspective.
The company discovered that electric fields can be manipulated to inhibit cell division in cancerous tumorous. Novocure calls this new method of treatment tumor treating fields, or TTFields for short, and is pushing hard to convince healthcare providers to add this new weapon to their arsenals. Its early success at winning over skeptics has led to explosive revenue growth, and its share price has soared.
Is Novocure a buy today, or is it too late to get in?
The technology
Nearly two decades ago, Novocure's founder discovered that electric fields could be used to inhibit division in certain types of cells. The company also figured out that tuning an electric field to a specific frequency would disrupt division in certain types of cells without having any impact on other types of cells (Novocure's Bill Doyle explained this process in great detail during a Ted Talk).
A key benefit of this technology is that TTFields could be fine-tuned to disrupt cell division in cancerous tumors while leaving nearby healthy cell alone. This allows TTField therapy to be administered with minimal side effects.
Novocure took its knowledge of TTFields and created a portable electric field generator called Optune, which won FDA approval to treat recurrent glioblastoma in 2011. Glioblastoma is an especially aggressive form of brain cancer that has a very low, five-year survival rate. Thankfully, Novocure showed last year that using Optune in combination with current standard-of-care treatments led to improved survival rates.
The opportunity
Novocure has launched Optune in the U.S., Europe, and Japan. The company's business model is to bill for Optune on a monthly basis. That's why a key metric for investors to watch is the number of active users that are on Optune at any given time.
Demand for Optune has grown steadily as providers, payers, and patients became more comfortable with the technology. In turn, Novocure's revenue has soared.
Metric 2015 2016 2017 2018*
Active patients 605 1,091 1,834 2,252*
Revenue $33.1 million $82.9 million $177 million $178 million*
*DATA AS OF SEPT. 30, 2018.
Glioblastoma is a rare form of cancer, so the company's current market opportunity for Optune is limited. However, the company believes that TTFields could also be useful in treating a wide variety of solid-tumor cancers down the road. Management is investing aggressively in R&D in an effort to capitalize on that potential.
How big could the company's total addressable market grow if TTFields are shown to be effective in other types of cancer? Here's an overview of Optune's label expansion potential:
Indication Status Potential Annual Patient Population in Target Markets
Glioblastoma Approved 14,000
Mesothelioma Pending approval 13,000
Brain Metastases Phase 3 trial end 2020 258,000
Lung cancer Phase 3 trial ends 2021 659,000
Pancreatic cancer Phase 3 trial ends 2022 223,000
These numbers are enormous when compared to the company's current active patient count of just 2,252. If Novocure can win approval in any of these indications, then its upside potential is truly massive.
Digging into the financials
Novocure has operated at a loss since its founding. The company is still losing money today, even with its considerable revenue growth. A key reason why is that the company has been plowing money into growing its commercial team and funding its late-stage R&D programs. If any of those clinical trials result in label expansion claims, that will prove to be money well spent.
Novocure's net loss for all of 2018 should come in right around $60 million or so. Funding that loss won't be a problem because the company had more than $226 million in cash in the bank as of the end of September.
Market watchers predict that the company's net loss will shrink considerably in 2019. If that happens, the company shouldn't have to tap investors for additional capital anytime soon.
Is NovoCure a buy?
For NovoCure to be a successful investment from here, it must be able to win label expansion claims into other types of cancer. Since regulatory success is never guaranteed, this isn't a good stock for risk-averse investors to buy.
Personally, I think the odds of Optune winning label expansion claims are quite good given that the company has already shown clinical success in treating brain cancer, and Optune's side effects are so minimal. That's why I decided to become a shareholder.
If you have a strong stomach for risk and want a stock that could turn into a home run, NovoCure might be for you.
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>>> Mysterious Private Jet Flight From Israel to Saudi Arabia Has Media Guessing
Bloomberg
By Alisa Odenheimer
October 24, 2019
https://www.bloomberg.com/news/articles/2019-10-24/mysterious-flight-from-israel-to-saudi-arabia-has-media-guessing?srnd=premium
A private jet took off from Ben-Gurion International Airport near Tel Aviv on Tuesday evening, landed for a few minutes in Amman, then proceeded to the Saudi capital, Riyadh, leaving Israeli media guessing who was on the plane.
Yossi Melman, who writes for the Maariv daily, tweeted that Prime Minister Benjamin Netanyahu or Mossad spy chief Yossi Cohen may have been on board the flight to the Arab kingdom, which has no diplomatic ties with Israel, possibly to discuss the situation in Syria.
Haaretz’s Avi Scharf tweeted that the trip was “EXtra rare.” He noted that U.S. Secretary of Defense Mark Esper was in Riyadh around the same time and questioned whether the U.S.-registered jet had brought an official for a “snap trilateral.”
@avischarf
EXtra rare: Israeli biz landed Riyadh ???? overnight for 1 hr, then back (n556us cl-60)
Unrelated (prob), ???? SecDef @EsperDoD was also in the Kingdom yesterday
avi scharf
@avischarf
Replying to @avischarf @EsperDoD
So earlier I said 'prob unrelated', because I thought Esper had already left KSA for Europe, but now I realize he's still in the neighborhood - he just appeared in Baghdad.
Did someone from Israel come for a snap trilateral in Riyadh? I don't know
The jet took off after about an hour in Saudi Arabia and returned to Israel, the Jerusalem Post reported. The same plane has also made trips between Tel Aviv and Cairo in recent months, it said.
Although Israel has no formal relations with Saudi Arabia, ties are gradually warming up, in part due to shared concerns over Iran’s growing influence in the region. In the absence of an Israeli-Palestinian peace deal, most of the cooperation has taken place behind the scenes.
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(perhaps it was the ghost of Mike Harari, lol)
https://en.wikipedia.org/wiki/Michael_Harari
>>> Foamix Pharmaceuticals (FOMX) -
https://finance.yahoo.com/news/3-top-biotech-stocks-major-041721066.html
Foamix Pharmaceuticals is also hopeful of getting to market and has two promising late-stage dermatological drugs in its pipeline. FMX101 targets the treatment of moderate-to-severe acne and has already had its NDA submitted. Management is also hopeful to hear some news from the FDA very soon. FMX103 targets moderate-to-severe rosacea, which has much less competition than competing acne treatments in the marketplace. It also made it through clinical three trials and an FDA decision is expected somewhere in the middle of 2020.
Cantor analyst Louise Chen reported on Foamix’s presentation at the firm's healthcare conference in early October, noting: "After listening to FOMX's presentation, we continue to look forward to the potential launches of FOMX's two late-stage products in the 2019/20 timeframe. We expect approval for the company's lead product candidate FMX101 for the treatment of moderate-to-severe acne." Chen rates FOMX an Overweight with $15 price target, which implies huge upside to the current share price of $2.80.
Research firm Cowen recently pointed out that Foamix is currently building out its sales force in anticipation of the potential launch of both dermatology candidates. Based off its price target of $30, it is effectively twice as bullish as Cantor.
Like many development-stage biotech firms, Foamix is in a precarious financial position and has accumulated a deficit above $200 million to bring these and related drugs to market. But with any positive FDA news, the share price will likely soar and open the gateway to plenty of opportunities to raise growth capital.
Returning again to TipRanks’ consensus analyst estimates, FOMX has received 3 "buy," ratings in the last three months, while the 12-month average price target lands at $17.00, or more than 500% ahead of the current share price.
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>>> Foamix Pharmaceuticals Ltd. (FOMX), a late clinical-stage specialty pharmaceutical company, develops and commercializes foam-based formulations for dermatological therapy in the United States, France, Denmark, and Germany. Its lead product candidates include FMX101, a novel topical foam formulation of the antibiotic minocycline that has completed third pivotal Phase III clinical trial for the treatment of moderate-to-severe acne; and FMX103, which is in Phase III clinical trial for the treatment of moderate-to-severe papulopustular rosacea. The company's product pipeline includes FCD105 and FMX109 for the treatment of moderate-to-severe acne vulgaris; and FMX110 for the treatment of papulopustular rosacea. Foamix Pharmaceuticals Ltd. has development and license agreements with Bayer HealthCare AG; LEO Pharma A/S; Mylan N.V.; and Actavis plc. The company was founded in 2003 and is headquartered in Rehovot, Israel.
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Eviation - >>> Electric Planes to Debut for Airline Serving Nantucket, Vineyard
Bloomberg
By Tara Patel
June 18, 2019
https://www.bloomberg.com/news/articles/2019-06-18/electric-plane-maker-eviation-clinches-first-customer-cape-air
Israeli venture-backed aircraft maker predicts supply crunch
‘We’re talking to everyone’ on future sales, Eviation CEO says
EVIATION AIRCRAFT (EVTNF)
Electric-plane company Eviation Aircraft Ltd., which just signed up its first customer, predicts that in a few years it may not be able to keep up with orders.
“We’ll have a supply issue, not a demand issue,” Chief Executive Officer Omer Bar-Yohay said in an interview at the Paris Air Show. The founder of the Israeli venture capital-backed developer said U.S. regional airline Cape Air has agreed to buy a “double-digit” number of planes. The carrier flies some 88 Cessna turbo-props on routes such as Boston to Martha’s Vineyard and New York to Nantucket.
Eviation was showcasing a prototype, transported in pieces to the biennial exhibition, and is “talking to everyone” about future sales, said Bar-Yohay. Prospective customers include major U.S. carriers like United Continental Holdings Inc. and JetBlue Airways Corp., which are interested in planes to feed hubs, he said.
Eviation’s plane, the Alice, is one of a host of electric models at the design stage, and its nine-passenger capacity and 650-mile range from a single charge could give it an edge in the commuter market, currently served by a variety of light aircraft. Interest in electric planes is growing as the aviation industry comes under criticism for increasing emissions of greenhouse gases.
Read: Stratospheric: What Happens to Airline Emissions Under Self-Rule
Eviation is planning a first flight later this year in the U.S., followed by the assembly of more planes in Arizona and Washington state and certification around 2021.
“We’re a bit ahead of the pack but I have no doubt others are coming,” Bar-Yohay said, adding that taking on a customer like Cape Air will also entail developing charging and maintenance infrastructure.
“The hurdles aren’t just about getting the plane out the door, but everything else that goes with them,” he said. “We need an environment to support the plane and trained engineers and mechanics.”
Aircraft Economics
Eviation contends its plane makes economic sense: Running costs for the Alice will be about $200 per flight hour versus $1,000 for a turboprop. The Alice will be slower than some conventional craft, with a cruising speed of 240 knots (276 miles per hour), half the pace of modern business jets but not far short of some turboprop models.
The company is targeting “middle mile” commutes like Paris to Toulouse, Oslo to Trondheim in Norway and San Jose to San Diego.
Read: Airbus May Make the Next Version of Top-Selling Jet a Hybrid
Based in Kadima, near Tel Aviv, Eviation was founded in 2015 by a team of aviation and technology specialists. It’s one of about 100 different electric-aircraft programs in development worldwide, up 30% since 2017, according to Roland Berger, a consulting firm.
Zunum Aero, backed by Boeing Co. and JetBlue, aims to bring a hybrid-electric commuter model to market by 2022, while MagniX Technologies Pty is developing a propulsion system for an all-electric plane with a similar date in mind. In September, it announced a successful ground test of a 350-horsepower motor attached to the nose section of a Cessna test rig.
Joby Aviation Inc. is aiming smaller, targeting the air-taxi market with a plane that would carry four passengers, travel 150 miles and fly at a few thousand feet. Unlike the Alice, it wouldn’t be pressurized. Uber Technologies Inc. has said it’s also working on a flying taxi as an extension of its ride-sharing product that would take off and land vertically and reach the market by 2023.
At the other end of the scale, Easyjet Plc has partnered with U.S.-based Wright Electric to develop a full-sized battery-powered airliner within a decade for flights of less than two hours, enough to link London with Paris or Amsterdam.
Siemens AG, Airbus SE and Rolls-Royce Holdings Plc are working on a hybrid-electric propulsion system, the E-Fan X, that would also power a relatively large aircraft. Roland Berger predicts that the first 50-seat hybrid airliner will enter fare-paying service by 2032.
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Eviation -- >>> All-electric jet firm Eviation announces US regional airline as first customer, predicts delivery in 2022
CNBC
JUN 18 2019
by David Reid
https://www.cnbc.com/2019/06/18/all-electric-jet-firm-eviation-announces-us-airline-as-first-customer.html
Venture capital-backed Eviation is developing a nine-seat electric aircraft.
The firm sees regional travel as being under served by aviation.
A prototype of its electric plane has been unveiled at the Paris Air Show.
Eviation chief executive Omer Bar-Yohay reveals future plans for his company’s nine-seat electric plane at the 2019 Paris Air Show.
PARIS — The Israeli start-up Eviation announced at the Paris Air Show that U.S regional airline Cape Air is to buy its electric aircraft.
Eviation is developing a nine-passenger aircraft designed to fly up to 650 miles at around 240 knots (276 miles per hour). A commercial jet would cruise around 500 miles per hour. The electric plane — called Alice with a prototype being unveiled at the show this week — is designed for the sort of distances usually conducted by train.
Cape Air is set to buy a “double-digit” number of the plane which has a list price of around $4 million each. It’s expected that any customer would be able to negotiate a smaller figure.
The company’s chief executive, Omer Bar-Yohay, told a press conference Tuesday that he expected to receive certification by late 2021, with deliveries predicted for 2022.
“This aircraft is not some future maybe. It is there, ready and waiting,” he said.
Bar-Yohay cited the contributions from Honeywell who built the plane’s controls as well as Siemens, and magniX who provided the electric motor and related functions.
A rendered image of the Eviation Alice. An electric aircraft designed to take 9 passengers up to 650 miles at 240 knots.
Source: Eviation
Bar-Yohay said the plane would now travel to Arizona in the United States where it would be flight tested before being put forward for certification with the U.S. FAA (Federal Aviation Administration).
The CEO added the plane should satisfy FAA concerns that it might create a backlog of training for pilots, as it was “probably one of the easiest planes to fly,” adding “this is one of the specimens that the FAA wants to see happen.”
The Eviation boss said that eventually, future planes would be built in the United States.
Most of Eviation’s funding is from Clermont Group, the private investment fund of Singapore-based billionaire Richard Chandler. Clermont has given Eviation $76 million in exchange for a 70% stake in the company, according to a filing with the U.S. Securities and Exchange Commission dated January 3.
In a in a letter to staff, Chandler said commercial-scale electric aircraft would “change the culture of air travel for future generations,” and that the aerospace industry was entering a new era.
“45% of all flights are under 500 miles – approximately the distance from London to Zurich, or New York to Detroit. This puts almost half of all global flights within the range of an electric motor.”
Clermont also owns and funds magniX, the firm that manufactures the three electric motors that provide the aircraft with roughly 900 kilowatts of power. Bar-Yohay claimed if there was a problem with the two wing engines, it could continue flying on the rear rotor only.
The CEO of magniX, Roei Ganzarski, also attended the launch, telling CNBC it was “exciting to see a dream come true.”
Ganzarski said his engines would be split between new clean sheet aircraft such as the Eviation and retrofitting existing small aircraft.
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>>> Radware Ltd. develops, manufactures, and markets cyber security and application delivery solutions for applications in physical, virtual, cloud, and software defined data centers worldwide. The company offers DefensePro, a real-time network attack prevention device; AppWall, a Web application firewall; and DefenseFlow, a cyber-command and control application. It also provides Alteon D Line, an application delivery controller/load balancer for Web, cloud, and mobile based applications; and LinkProof NG, a multi-homing and enterprise gateway solution for connectivity of enterprise and cloud-based applications. In addition, the company offers Security Updates Subscription, which provides security updates to protect customers against the latest threats; ERT Active Attackers Feed that provides customers with information pertaining to attack sources recently involved in DDoS attacks; Alteon Global Elastic License that captures application lifecycle for large ADC deployments; APSolute Vision, a management and monitoring tool for company's application delivery and cyber security solutions; and MSSP Portal, a DDoS detection and mitigation service portal. Further, it provides Cloud DDoS Protection Service, which offers a range of enterprise-grade DDoS protection services in the cloud, as well as technical support, professional, managed, and training and certification services to its customers. The company sells its products primarily to independent distributors, including value added resellers, original equipment manufacturers, and system integrators. Radware Ltd. was founded in 1996 and is headquartered in Tel Aviv, Israel.
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>>> Aquanomix and AMIAD Water Systems join forces!
January 22, 2018
https://aquanomix.com/aquanomix-amiad-water-systems-join-forces/
AMIAD USA Inc. AND AQUANOMIX JOIN FORCES TO TRANSFORM INDUSTRIAL WATER MANAGEMENT
Charlotte, N.C., (January 22, 2018) … Amiad USA Inc., a global leader in water treatment and filtration solutions, and Aquanomix LLC, a technology leader pioneering the Internet of Things (IOT) in water management, announce a strategic partnership that will transform cooling tower water management.
The two companies will combine their products in GenesisTM– a hardware and software system – provides the user with a real-time risk management platform that offers greater protection for critical cooling systems. The system will increase efficiency, save costs and reduces the risks of biological activity in cooling systems. The product will be available March 1, 2018.
“Symphony GenesisTM is the first system that marries water treatment hardware with optimization software in one easy to use package” said Michael Poth, Amiad USA President. “We anticipate great interest from anyone who treats water in cooling tower installations.”
The partnership will leverage Amiad’s engineering and development capabilities and the revolutionary SymphonyTM cloud-based, water-monitoring platform
Water management programs for cooling tower systems address four key elements: scale, corrosion, microbiology, and fouling. Historically, responsibility for these critical elements has been divided between mechanical and chemical areas of discipline. Chemistry takes care of scale, corrosion, and microbiology control. Mechanical filtration removes fouling components, such as dirt and other airborne particulates, which can act as nutrient sources for microbiological organisms. GenesisTM is the first product to monitor all four elements in a single system.
“By joining forces, we have enabled our customers with an intuitive risk management platform” said Rob O’Donnell, Aquanomix CEO. “We believe this product could become the industry benchmark.”
“We’ve blended data management and proven filtration technology” added Poth. “Genesis will provide critical data to property managers, building owners, and risk managers who can expect to lower their operating costs because they have reduced water and energy use.”
Each partner plays a key role in production and distribution. Amiad makes the complete skids – piping, filtration, pumps, and more – for the system. Aquanomix provides sensors and hardware for the monitoring system and the software. Customers can purchase Symphony GenesisTM through the Aquanomix distribution network. Support for software is through Aquanomix’s Davidson, NC headquarters, and on-site support of the system is provided by both companies.
About Amiad
Amiad USA Inc. is the North American branch of Amiad Water Systems, a leading producer of automatic, self-cleaning water treatment and filtration products and systems. Through its engineering skills and ability to innovate, Amiad provides cost-effective, green solutions for the industrial, municipal, irrigation, oil and gas, and ballast water markets. In these segments, its patented products are being integrated into the core of systems for filtration and water treatment, micro-irrigation, membrane protection, wastewater and potable water treatment, cooling systems, and sea water filtration.
Headquartered in Mooresville, N.C., Amiad USA Inc.provides these solutions through a comprehensive network of distributors to customers throughout North America.
About Aquanomix
Aquanomix is an environmental technology company that delivers water optimization and energy-saving platforms for water-based systems. Aquanomix has pioneered the emerging water reuse market in the U.S. marketplace. The company is best known for its Nexus Number, which delivers the building’s water quality and heat exchanger efficiency data into a single portal, straight to the building’s owners and operators.
Headquartered in Davidson, N.C., Aquanomix developed the SymphonyTM platform to explore, define, and predict intrinsic relationships among environmental, operating, and economic factors that drive cooling water generation through real-time data aggregation and analysis.
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>>> Intec Pharma Ltd. (NTEC), a clinical stage biopharmaceutical company, focuses on developing drugs based on its proprietary Accordion Pill platform technology in Israel. Its Accordion Pill is an oral drug delivery system that is designed to enhance the efficacy and safety of existing drugs and drugs in development by utilizing a gastric retention and specific release mechanism. The company's lead product candidate is Accordion Pill Carbidopa/Levodopa (AP-CDLD), which is in a Phase III clinical trial for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients. It is also developing Accordion Pill Zaleplon (AP-ZP) that is in a Phase III clinical trial for the treatment of insomnia, including sleep induction and for enhancing of sleep maintenance; Accordion Pill, which has completed a Phase I clinical trial for the prevention and treatment of gastroduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug induced ulcers; and Accordion Pill platform with Cannabidiol and 9-Tetrahydrocannabinol, (AP-CBD/THC), which is in a Phase I clinical trial for the treatment of various indications, including low back neuropathic pain and fibromyalgia. The company was formerly known as Intec Pharmaceuticals (2000) Ltd. and changed its name to Intec Pharma Ltd. in March 2004. Intec Pharma Ltd. was founded in 2000 and is based in Jerusalem, Israel.
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Mellanox - >>> NVIDIA joins Intel in bidding war for major Israeli chip maker
It might be close to buying Mellanox.
Engadget
Jon Fingas
3-10-19
https://www.engadget.com/2019/03/10/nvidia-enters-bidding-war-for-mellanox/?yptr=yahoo
If you needed any further evidence that NVIDIA is becoming more of a direct competitor for Intel, you might just have it. A Calcalist source claimed that NVIDIA has made an offer to acquire Mellanox, a chip maker best known for its high-performance computing and networking tech. While it's not clear how much NVIDIA has been willing to pay, Reuters insiders said that NVIDIA could pay more than $7 billion -- well past the $6 billion Intel reportedly offered a few months ago.
Mellanox and Intel have declined to comment, while NVIDIA wasn't available for comment on the weekend. Xilinx is also believed to be involved in the bidding, but Reuters believed that NVIDIA is close enough that it could unveil a deal as soon as March 11th.
While the exact reasons for a potential deal aren't clear, NVIDIA would have more than a few incentives to buy Mellanox -- some of which you might notice. It could be most helpful for servers, supercomputers and other situations where you need many processors working in tandem. At the same time, it could also be useful for self-driving cars (where multiple processors may have to coordinate actions), or even ensuring fast connections between multiple GPUs in workstations and gaming PCs.
For Intel, it would be more of a defensive play. Intel and Mellanox have both cornered the market for the InfiniBand technology used to link computer clusters, and this could help keep the technology out of the hands of NVIDIA, AMD and other competitors. It could also help with Intel's ambitions as it eyes quantum computing and other technologies that could depend on very fast connections.
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>>> Israel flying to moon after SpaceX launch
2-22-19
AP
https://www.msn.com/en-us/news/technology/israel-flying-to-moon-after-spacex-launch/ar-BBTUCJS?OCID=ansmsnnews11#page=2
CAPE CANAVERAL, Fla. — An Israeli spacecraft rocketed toward the moon for the country's first attempted lunar landing, following a launch Thursday night by SpaceX.
A communications satellite for Indonesia was the main cargo aboard the Falcon 9 rocket, which illuminated the sky as it took flight. But Israel's privately funded lunar lander — a first not just for Israel but commercial space — generated the buzz.
Israel seeks to become only the fourth country to successfully land on the moon, after Russia, the U.S. and China. The spacecraft — called Beresheet, Hebrew for Genesis or "In The Beginning" — will take nearly two months to reach the moon.
"We thought it's about time for a change, and we want to get little Israel all the way to the moon," said Yonatan Winetraub, co-founder of Israel's SpaceIL , a nonprofit organization behind the effort.
The moon, nearly full and glowing brightly, beckoned as it rose in the eastern sky. Within an hour after liftoff, Beresheet was already sending back data and had successfully deployed its landing legs, according to SpaceIL.
"We'll keep analyzing the data, but bottom line is we entered the very exclusive group of countries that have launched a spacecraft to the moon," said Yigal Harel, head of SpaceIL's spacecraft program.
Prime Minister Benjamin Netanyahu was watching the launch live from the Israeli control center in Yehud, near Tel Aviv.
"This is a big step for Israel, but a giant step for Israeli technology," he said.
The four-legged Beresheet, barely the size of a washing machine, will circle Earth in ever bigger loops until it's captured by lunar gravity and goes into orbit around the moon. Touchdown would be April 11 at the Sea of Serenity.
NASA's Apollo missions in the 1960s and 1970s took about three days to get astronauts to the moon, but they used monstrous Saturn V rockets. The $100 million Beresheet mission couldn't afford its own rocket — even a little one — so the organizers opted for a ride share. That makes for a much longer trip; the moon right now is nearly 230,000 miles (370,000 kilometers) away.
"This is Uber-style space exploration, so we're riding shotgun on the rocket," Winetraub explained at a news conference on the eve of launch.
The U.S. Air Force also has a small research spacecraft aboard the rocket, for a one-year mission in orbit around Earth.
The Soviet Union was the first to put a spacecraft on the moon, Luna 2, in 1959. NASA followed with the Ranger 4 spacecraft in 1962. Last month, China became the first country to land on the far side of the moon.
Apollo 11 moonwalker Buzz Aldrin quickly offered congratulations following Thursday's launch. So did NASA Administrator Jim Bridenstine, who called it "a historic step for all nations and commercial space as we look to extend our collaborations beyond low-Earth orbit and on to the moon." NASA has a laser reflector aboard Beresheet and is offering its Deep Space Network for communication.
"All the best to @TeamSpaceIL as it starts its journey tonight on a @SpaceX #Falcon9 from Florida to my old stomping ground ...the moon," Aldrin tweeted.
The Beresheet mission originally was part of the Google Lunar XPrize competition and even made the final cut before the contest ended last year without a winner. The organizers decided to press ahead on their own, with donations from billionaires as well as schoolchildren.
Lunar surface operations are meant to last just two days. Beresheet will measure the magnetic field at the landing site, and send back data and pictures. A time capsule is aboard the lander — which includes a picture of Israeli astronaut Ilan Ramon, who died aboard space shuttle Columbia in 2003 — as well as a lunar library containing 30 million pages on a disk from the U.S.-based Arch Mission Foundation.
Ramon's widow, Rona, was a big supporter of Beresheet; she died of cancer in December.
Following liftoff, SpaceX recovered the first-stage booster, which flew twice last year. The booster landed smoothly on an offshore ocean platform, after the hottest re-entry yet, according to SpaceX founder and chief executive Elon Musk. Sparks from burning metal were visible in the landing video.
Musk said the booster will fly a fourth time in April, during a launch abort test of the new crew Dragon capsule. No one will be aboard.
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Accelerated Evolution Biotechnologies
>>> Israeli scientists claim they'll have cancer cure in a year
By GINA SALAMONE
NEW YORK DAILY NEWS
JAN 29, 2019
https://www.nydailynews.com/life-style/health/ny-fea-cancer-cure-year-israeli-scientists-20190129-story.html
A group of Israeli scientists say they’ll have a cure for cancer within a year.
The treatment is being cooked up by Accelerated Evolution Biotechnologies Ltd. , a drug development company established in 2000, according to the Jerusalem Post.
“We believe we will offer in a year’s time a complete cure for cancer,” Dan Aridor, chairman of the board for AEBi, told the Post.
“Our cancer cure will be effective from day one, will last a duration of a few weeks and will have no or minimal side-effects at a much lower cost than most other treatments on the market,” Aridor added. “Our solution will be both generic and personal.”
The treatment is called MuTaTo, which stands for multi-target toxin, and is designed to act as a cancer antibiotic. MuTaTo uses several cancer-targeting peptides for each cancer cell at the same time, combined with a strong peptide toxin that would kill cancer cells, according to the Post.
“We made sure that the treatment will not be affected by mutations; cancer cells can mutate in such a way that targeted receptors are dropped by the cancer,” Dr. Ilan Morad, CEO of AEBi, said. “The probability of having multiple mutations that would modify all targeted receptors simultaneously decreases dramatically with the number of targets used.
“Instead of attacking receptors one at a time, we attack receptors three at a time — not even cancer can mutate three receptors at the same time,” Morad added.
AEBi is about to begin clinical trials that will wrap up in a few years. “Our results are consistent and repeatable,” Aridor said.
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>>> Magal Security Systems Ltd. (MAGS) develops, manufactures, markets, and sells perimeter intrusion detection sensors, physical barriers, video analytics and video management systems, and cyber security products and systems worldwide. It operates through three segments: Perimeter Products, Turnkey Projects, and Video and Cyber Security. The company offers perimeter security products that enable customers to monitor, limit, and control access by unauthorized personnel to specific regions or areas. Its perimeter security systems include fence mounted detection systems; detection grids, gates, and fences to protect water passages, VIP residences, and other outdoor applications; buried sensors; hybrid perimeter intrusion detection and intelligent lighting systems; electrical field disturbance sensors; and microwave sensors. The company also provides integrated intelligent video management solutions for security surveillance and business intelligence applications; and cyber-security products for monitoring, securing, and the active management of wired, wireless, and fiber optic communication networks, as well as turnkey solutions. In addition, it offers RoboGuard, a platform that runs on a rail along the perimeter of protected sites; and life safety/duress alarm products to protect personnel in prisons. Further, the company provides MTC-1500I, a dual technology outdoor surveillance system; Fortis4G, a fourth generation command and control system; StarNet 2, a security management system; and Network Manager, a middleware package. Its products are used to protect national borders, military bases, power plants, airports, sea ports, postal facilities, prisons, banks, retail operations, hospitals, municipal security, sporting events, and industrial locations from terrorism, theft, and other security threats. The company sells its products through system integrators and distribution channels. Magal Security Systems Ltd. was founded in 1965 and is headquartered in Yehud, Israel. <<<
Companies founded by alumni of Israel's Unit 8200 -
https://en.wikipedia.org/wiki/Unit_8200
>>> Former soldiers of Unit 8200 have gone on to found many IT companies, among them:
Silverfort
CloudEndure
Secdo
ICQ
Check Point
Imperva
Incapsula
Cloudinary
Cybereason
CTERA Networks
Viber
NSO Group
Palo Alto Networks
indeni
NICE
AudioCodes
Gilat
Leadspace
EZchip
Onavo
CyberArk
PrimeSense
FST Biometrics
Radware
Hyperwise Security
Adallom
Argus Cyber Security
BioCatch
XIV
Infinidat
CTS Labs
Crosswise
OverOps
PerimeterX
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>>> Pepsi to Buy SodaStream for $3.2 Billion in Shift to Healthier Drinks
Cola giant faces pressure to overhaul North America beverage business as core brands stumble
By Saabira Chaudhuri and Jennifer Maloney
Aug. 20, 2018
https://www.wsj.com/articles/pepsi-continues-move-away-from-sugary-drinks-with-sodastream-deal-1534749310
PepsiCo Inc. PEP -0.10% has agreed to buy one of its fiercest critics, seltzer-machine maker SodaStream International Ltd. SODA 9.44% , for $3.2 billion, the latest move by the beverage-and-food giant to broaden its offerings beyond sugary sodas and salty snacks.
Israel-based SodaStream SODA 9.44% makes countertop machines that allow consumers to carbonate tap water and other beverages at home by filling a reusable bottle and flavoring it with syrups. As consumers have shifted from sugary soft drinks to bottled water, the Nasdaq-listed company has pivoted to promote itself as a maker of homemade seltzer rather than a maker of homemade soda.
PepsiCo has been under pressure this year to restructure its North America beverage business amid weak sales of its core brands Pepsi-Cola, Mountain Dew and Gatorade. The sales slump came after the company last year shifted too much shelf space and advertising money to new, healthier brands.
The deal creates somewhat of an awkward pairing. SodaStream has singled out PepsiCo and other beverage companies in public statements and advertising campaigns criticizing bottled-water makers for polluting the environment.
“Shame on PepsiCo,” SodaStream Chief Executive Daniel Birnbaum said last year when the soda giant launched its premium bottled-water brand LIFEWTR. “I’ll say it till I’m blue in the face: The bottled-water industry is the biggest marketing scam of all time.”
Americans Still Consume Too Much Sugar in Drinks
The U.S. soft-drink industry vowed in 2014 to cut beverage calories in the American diet 20% by 2025. But a drop in diet soda consumption and the rise of energy drinks has slowed progress.
“SodaStream’s point of view is that they want a healthier, more sustainable planet,” a goal the soda giant shares, PepsiCo finance chief Hugh Johnston said in an interview. “There was a good cultural match here in terms of the values.” In discussions between the two companies over the past several years, “we got more comfortable that, in fact, we think about things in the same way,” he said.
A SodaStream spokeswoman referred questions to PepsiCo.
Shares in PepsiCo rose after the announcement but later erased those gains and closed off 12 cents at $114.84. SodaStream’s shares rose 9.4% to $142.111. Wells Fargo analyst Bonnie Herzog offered a skeptical view of the deal, saying it is questionable whether buying SodaStream will do much to help PepsiCo’s efforts to improve volumes in its North American drinks business.
Mr. Johnston said the deal isn’t a response to the company’s flagging North America beverage sales, but rather an opportunity to expand SodaStream’s sales around the world and to give PepsiCo better reach into markets such as Germany and Japan, where SodaStream is strong. It also gives PepsiCo entree into what Mr. Johnston called “in-home beverage creation.”
Under departing Chief Executive Indra Nooyi, PepsiCo has expanded from its cola roots into hummus, kombucha and other healthier products, although results have been mixed. The company has set a target for sales growth of nutritious products to outpace the rest of the portfolio by 2025.
Incoming PepsiCo CEO Ramon Laguarta played a key role in the SodaStream deal, two people familiar with the matter said.
Mr. Laguarta, who is currently PepsiCo’s president, approached Mr. Birnbaum about four weeks ago about doing a deal, one of the people said. The pact came together quickly, with no other bidders involved, both people familiar with the matter said.
PepsiCo had built a yearslong relationship with SodaStream under Ms. Nooyi, who expected the company would help the soda giant pivot to the healthier and more environmentally friendly offerings she envisioned. PepsiCo had previously approached SodaStream at least once in the past eight years, people familiar with the matter said. In 2015, PepsiCo briefly sold its cola with SodaStream machines as an experiment in a few dozen stores across the U.S.
In addition to LIFEWTR, PepsiCo sells the Aquafina water brand in the U.S. and earlier this year launched a new brand of flavored seltzer called Bubly.
Sparkling water has grown more quickly than the overall bottled water category in the U.S., clocking volume growth of 38% last year, according to data from industry tracker Beverage Marketing Corp. That compares with 7% growth for the overall packaged-water industry.
Bubbling Up
U.S. sparkling-water consumption has grown sharply in recent years.
Consumers are turning to fizzy water as a replacement for sugary soft drinks and diet sodas. Meanwhile, sales of bottled water—a much bigger category—have slowed amid competition from sparkling water, tea, coffee and other beverages.
The Israeli company has courted controversy in recent years because its former location—in the West Bank town of Ma’aleh Adumim—made it a target for campaigns urging consumers to dump its products if the company remained in disputed territory.
In 2014, SodaStream gave in to the political pressure and announced it would move its headquarters to Tel Aviv and its manufacturing operations to southern Israel.
The countertop carbonation-machine maker is widely accepted to have invented the notion of make-it-at-home soda and has roots going back to 1903, when it was founded in London by a gin distiller.
In early years it was marketed to Britain’s upper class, and was reportedly a favorite of the royal household. But home carbonation of tap water eventually took off and the company’s heyday came in the 1970s and 1980s, reaching 10 million U.K. homes, alongside a marketing catch phrase: “Get Busy With the Fizzy.”
A series of changes of ownership, which included Reckitt & Coleman and Cadbury Schweppes, grounded momentum. Eventually the company was bought by Soda-Club, its Israeli distributor. Then private equity took a controlling interest, appointed Mr. Birnbaum—previously the Israel CEO of U.S.-based sports-apparel company Nike Inc.—as CEO, and listed the stock in 2010. SodaStream now has 2,000 employees.
Earlier this month SodaStream reported its revenue had climbed 31% to $171.5 million for the quarter ended June 30, while its net income rose 82%. The company described the quarter as its best to date.
A backlash against single-use plastic has taken hold in some countries in Western Europe, where SodaStream makes the majority of its sales.
One SodaStream ad featuring “Game of Thrones” actors Hannah Waddingham and Thor Bjornsson has captured 2.7 million views on YouTube. It parodies a scene from the television series, with a woman crying “Shame!” as she follows a man carrying bottled sparkling water out of a grocery store.
As recently as this month, SodaStream had been planning a fall campaign “against single-use plastic bottles and big beverage,” a company spokeswoman said in early August.
PepsiCo said Monday that buying SodaStream is one of several ways in which the soda giant is reducing the use of plastic bottles. Others include Drinkfinity, a kit that includes reusable bottle and recyclable flavor pods, and Aquafina water stations, which dispense water with or without flavors in offices and on college campuses.
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>>> Israel launches massive military strike against Iranian targets in Syria
Washington Post
By Loveday Morris, Ruth Eglash and Louisa Loveluck
5-10-18
https://www.msn.com/en-us/news/world/israel-launches-massive-military-strike-against-iranian-targets-in-syria/ar-AAx31tl?OCID=ansmsnnews11
MOUNT BENTAL, Golan Heights — The Israeli military said Thursday that it had bombed dozens of Iran-linked military facilities in Syria, as tensions between the three countries soared.
The army said in a statement that its fighter jets had targeted Iranian intelligence and logistics sites around Damascus, as well as munition warehouses, observation and military posts — what a top official said were most of their facilities in the country.
The attacks followed a wave of overnight missile strikes directed at Israeli territory — all of them apparently intercepted — that Israel blamed on Iran.
An Israeli military spokesman said the rockets were fired by Iran’s Quds Force, a special forces unit affiliated with Iran’s Revolutionary Guard Corps, marking the first time Iranian forces have ever fired directly on Israeli troops.
From Mount Bental on the Golan Heights, Israeli military spokesman Lt. Col. Jonathan Conricus pointed out where he said an Iranian rocket salvo had fired toward Israel just after midnight. “We saw it was very clear what the Iranians were doing, attacking Israel from Syrian soil,” he said.
Four of the 20 rockets were on target, he added, but were then intercepted, while the rest fell short. Israel responded by hitting 70 Iran-linked sites in Syria. “This was by far the largest strike we have done, but it was focused on Iranian sites,” he said.
Syrian air defenses were also struck after they fired on Israeli jets, he acknowledged.
Israel and Iran have been on a collision course in Syria, as Israel has vowed not to let Iran build a presence and escalated attacks against Iranian targets across the border. Iran had vowed retaliation after seven of its soldiers were killed by an Israeli airstrike in April.
Analysts say President Trump’s scrapping of the Iran deal means it has less to lose by retaliating, and the move has added weight to hard-liners in the Islamic Republic who want to show strength.
In a statement carried by Syria’s state news agency, an unnamed foreign ministry official described the overnight attacks as a “new phase of aggression.”
In Washington, a statement from White House press secretary Sarah Huckabee Sanders condemned Iran’s “provocative rocket attacks from Syria against Israeli citizens” and supported Israel’s “right to act in self-defense.”
“The Iranian regime’s deployment into Syria of offensive rocket and missile systems aimed at Israel is an unacceptable and highly dangerous development for the entire Middle East,” the statement said. “Iran’s Islamic Revolutionary Guard Corps (IRGC) bears full responsibility for the consequences of its reckless actions.” It called on Iran and its allies, including Hezbollah, “to take no further provocative steps.”
The Syrian Observatory for Human Rights, a monitoring group, said that at least 23 people were killed in Thursday’s Israeli strikes across Syria, including five Syrian soldiers and 18 allied militia men, without specifying whether any were Iranian. The Syrian army, however, said only three died in the strikes and most of the Israeli missiles were intercepted.
Russia, meanwhile, issued its own analysis of the attack, saying it was carried out by 28 Israeli fighter jets firing 60 missiles and another 10 surface-to-surface missiles with Syrian air defenses intercepting half of them.
There were no immediate statements from Iran after the Israel strikes. On Wednesday, however, Iran’s defense minister, Brig. Gen. Amir Hatami, pledged that Iran would continue to develop its missile capabilities. Hatami, speaking to officials in Tehran, made no direct mention of Israel or other nations, but cited pressures from “enemies of Iran,” according to Iran’s Fars news agency.
Tehran’s strong support for Syrian President Bashar al-Assad has allowed it to deepen its foothold across Syria, but Iranian media downplayed Tehran’s role in the violence, depicting the clashes instead as between Israel and Syria.
RELATED: The shadow war between Israel and Iran takes center stage
Israel’s Defense Minister Avigdor Liberman said the strikes targeted “almost all of the Iranian infrastructure in Syria.”
The army spokesman Brig. Gen. Ronen Menalis also said Israel could still do plenty more if it was so inclined.
“What we did tonight is only the tip of the iceberg of the Israeli Army’s capability,” he said Thursday morning on Israel Army Radio.
Among the targets that were hit were Iranian intelligence sites, a logistics headquarters belonging to the Quds Force, military logistics compound in Al-Kiswah, an Iranian military compound in Syria, north of Damascus, munition storage warehouses of the Quds Force at the Damascus International Airport, intelligence systems and posts associated with the Quds Force, observation and military posts and munition in the buffer zone, the Israeli army said.
Speaking at the annual Herzliya Conference on Thursday morning, Liberman said his country’s position was clear, “we will not allow Iran to turn Syria into a front line post against Israel.”
Air raid sirens sounded in the Golan Heights shortly after midnight Thursday. In nearby Tiberias, on the edge of the Sea of Galilee, explosions could be heard above the music of bars entertaining busloads of tourists. The explosions were followed by sporadic fire into the early morning hours.
Israeli residents of the Golan Heights reported a restless night in bomb shelters but that life had returned to normal Thursday morning. Schools were open and farmers continued with work as usual.
Targets belonging to the al-Quds Force and the Revolutionary Guard throughout Syria have taken a significant hit,” said army spokesman Menalis. “In the next few hours they will understand very well how much we have hit them.”
Both Russia and France have called for a de-escalation of the situation.
<<<
>>> With Three Rapid Strokes, Netanyahu Advances Agenda Against Iran
By DAVID M. HALBFINGER
NY Times
5-3-18
http://www.msn.com/en-us/news/world/with-three-rapid-strokes-netanyahu-advances-agenda-against-iran/ar-AAwEDsR?ocid=mailsignout
JERUSALEM — In three bold moves this week — with F-15s, a PowerPoint presentation and the passage of a contentious new law — Prime Minister Benjamin Netanyahu has strengthened his hand in trying to foil Iran’s strategic ambitions, while potentially pulling the two nations closer to direct conflict.
In Syria late Sunday, F-15s, widely assumed to be Israel’s, struck facilities where Iran and its proxies had entrenched themselves. The attack on a storage site near Hama destroyed 200 missiles and killed at least 16 people, 11 of them Iranians.
In Tel Aviv the next evening, Mr. Netanyahu gave a bravura PowerPoint performance on live television from inside the Defense Ministry, flaunting the booty pilfered from a secret Tehran warehouse by an intrepid Mossad team — evidence, he said, of Iranian deceit about its long-running efforts to develop a nuclear bomb.
The revelation came less than two weeks before President Trump is to announce a decision on whether to withdraw from the international agreement to curb Iran’s nuclear program. Israeli officials portrayed it as an attempt to provide Mr. Trump — Mr. Netanyahu’s close ally — with backing for the decision, which they believe the president has already made.
Even as Mr. Netanyahu was speaking, his coalition in Parliament was pushing through a bill that would shift the power to go to war or carry out a military operation from the full cabinet to the smaller security cabinet — and, under “extreme circumstances,” allow the prime minister and defense minister alone to order such action.
In short order, Mr. Netanyahu had managed to exploit important political, military and intelligence advantages to advance his agenda on both the nuclear and conventional fronts, intensify the pressure on Iran, and free his hand under Israeli law to take the country to war without cabinet approval.
Taken together, his moves have prompted longtime observers of the prime minister, whom they have long credited with a healthy aversion to all-out warfare, to ask if he may have turned to a grim new way of thinking.
“All these years he was trigger-unhappy,” said Nahum Barnea, a respected columnist at Yediot Ahronoth. “And I believe that we should appreciate him for being so cautious about using military power. Now, it seems that he is pushing everybody toward a more hostile environment.”
Mr. Barnea said the hostile political environment Mr. Netanyahu faces could also be a factor: He is awaiting a likely indictment in a sprawling corruption scandal; he is believed to want to hold elections before any criminal charges materialize; and he has been presenting himself to his political base as the only Israeli leader capable of keeping the country safe.
“I don’t rule out any reason,” Mr. Barnea said. “And I’m sure there is more than one reason.”
All three actions this week further Mr. Netanyahu’s longtime goals.
As early as 2010, he sought to prepare for an attack on Iran’s nuclear facilities, but was stopped repeatedly by his own cabinet. He railed against the 2015 Iran nuclear agreement from its inception under President Barack Obama, contending it would allow Tehran to threaten Israel with atomic weapons within a decade’s time. And he has vowed for months to prevent Iran from establishing a conventional offensive threat to Israel from inside Syria.
The new war powers law, approved Monday on a vote of 62 to 41, was not written with the current skirmishes with Iran or the current prime minister and defense minister in mind, according to one of the measure’s architects.
Still, critics note that the corruption cases against Mr. Netanyahu, and the lack of security experience in his defense minister, Avigdor Lieberman, could raise questions about their motivations should they decide to take Israel to war.
And while the power applies only in “extreme circumstances,” the law does not define what those are.
Some experts said the new law may not have a dramatic effect. The prime minister and defense minister are unlikely to go to war without strong political backing and the support of the military and security agencies, some experts said, which have proven in the past to be cautious.
“A government cannot go to war, no matter what the law says, without a national consensus,” said Shlomo Avineri, professor emeritus of political science at the Hebrew University of Jerusalem. “Obviously a prime minister under investigation is limited by the kind of choices he can take, and they will be scrutinized even more than usual.”
Crucially, the show of force in Syria and the show-and-tell of spycraft both come as Iran is constrained from plunging into a shooting war with Israel, either by itself or by proxy. Its own public is increasingly restive. Its close ally in Lebanon, Hezbollah, which might otherwise be counted on to retaliate against Israel, is reined in, at least for the moment, by elections on May 6, in which it is fielding candidates.
Most of all, with President Trump set to announce his decision on the nuclear agreement by May 12, Iran is unlikely to give Mr. Trump any fresh excuses to quit it.
“That’s just an opportunity for Israel to do what needs to be done, and at relatively low cost,” said Daniel Shapiro, the former United States ambassador to Israel under Mr. Obama.
Analysts said Mr. Netanyahu’s fight to arrest Iran’s conventional-arms buildup in Syria was linked not merely by coincidence of timing to his efforts to deny Tehran a nuclear option. Just as North Korea amassed a huge arsenal of artillery to threaten Seoul while it worked to develop nuclear arms, Mr. Shapiro said, Iran is seeking to threaten Israeli territory, with drones and precision-guided missiles from within Syria, “while it uses time and negotiations and delays to advance their nuclear ambitions.”
Amos Yadlin, a former chief of Israel’s military intelligence who now heads the Institute for National Security Studies in Tel Aviv, said Iran’s nuclear and conventional threats were “aimed at the same goal: to destroy Israel.”
Mr. Yadlin said the nuclear deal had succeeded in stopping Iran from pursuing nuclear weapons for a number of years.
“So they built a conventional force against Israel in Syria — with ballistic missiles, with precise guidance,” he said. “And this is the most dangerous threat towards Israel today in 2018.”
If Mr. Trump walks away from the nuclear agreement, Mr. Yadlin said, depending on Iran’s response it could lead to a military clash between Israel and Iran perhaps years down the road. “But a clash in the north can happen this week, this month,” he warned.
Increasingly in recent years, Mr. Netanyahu has spoken with almost prophetic fervor about stopping Iran. Yet for all of his assertive moves this week, analysts said it remained unclear where exactly they were intended to lead. In particular, if he succeeds in scuttling the nuclear agreement with Iran, then what?
“He didn’t give us Israelis any logical scenario for what will happen after the American decision,” Mr. Barnea said. “How the Iranians will be less nuclear after it. How confident he is that this action by the U.S. will deter Iran and not speed up its nuclear process. This is something he never elaborated on. And it’s time he does it.”
The heightened tension with Iran, along with the Knesset’s enactment of the lowered threshold to declaring war, came as a surprise, Mr. Barnea said. “Suddenly, they’re faced with a big question mark: Where are we heading?”
“Maybe,” Mr. Barnea added, “he feels his war has come.”
<<<
>>> Verint Systems Inc. (VRNT) provides actionable intelligence solutions and value-added services worldwide. Its Customer Engagement Solutions segment provides automated quality management, automated verification, branch surveillance and investigation, case management, chat engagement, coaching/learning, compliance recording, customer communities, desktop and process analytics, digital feedback, email engagement, employee desktop, enterprise feedback, financial compliance, full-time recording, gamification, identity analytics, internal communities, knowledge management, mobile workforce, performance management, robotic process automation, social analytics, speech and text analytics, virtual assistant, voice self-service, voice self-service fraud detection, Web/mobile self-service, work manager, and workforce management solutions. The company's Cyber Intelligence Solutions segment offers cyber security solutions; intelligence fusion center and Web and social intelligence software that enables collection, fusion, and analysis of data from the Web; network intelligence suite, which generates critical intelligence of data captured from various network and open sources; and situational intelligence software enables security organizations to fuse, analyze, and report information, as well as take action on risks, alarms, and incidents. The company also offers a range of customer services, including implementation and training, consulting and managed, and maintenance support services. It sells its solutions through its direct sales team; and through indirect channels, such as distributors, systems integrators, value-added resellers, and original equipment manufacturer partners. The company was founded in 1994 and is headquartered in Melville, New York <<<
>>> Teva shares plummet 10% after downbeat 2018 guidance
By Emma Court
Feb 8, 2018
https://www.marketwatch.com/story/teva-shares-plummet-95-after-downbeat-2018-guidance-2018-02-08?siteid=bigcharts&dist=bigcharts
Teva Pharmaceutical Industries Ltd. TEVA, -7.46% shares plummeted 10.2% in premarket trade Thursday after the company reported fourth-quarter profit and revenue beats but provided 2018 guidance that fell well short of expectations. The company reported a loss of $11.60 billion, or a loss of $11.41 per share, after a loss of $1.04 billion, or a loss of $1.10 per share. Adjusted earnings-per-share were 93 cents, compared with the FactSet consensus of 77 cents. Revenue declined to $5.46 billion from $6.49 billion, compared with the FactSet consensus of $5.29 billion.
The company also recorded goodwill impairments totaling $17.1 billion in 2017, mainly relating to its U.S. generics reporting unit due to various competitive pressures. Teva expects 2018 revenue of $18.3 billion to $18.8 billion, compared with the FactSet consensus of $19.24 billion, and 2018 adjusted EPS of $2.25 to $2.50, compared with the FactSet consensus of $3.83. Teva also said that its migraine therapy fremanezumab -- which got fast track designation from the Food and Drug Administration in December -- has an active pharmaceutical ingredient manufactured solely by Celltrion 068270, +6.02% which recently received a FDA warning letter for its South Korea facility. The warning letter will likely result in a delayed approval, Teva said, adding that it is in "active dialogue" with the FDA. "2017 was a challenging year for Teva.
Starting 2018 we are focused on meeting our financial obligations and ensuring a much more solid and sustainable business model going forward," said Chief Executive Kåre Schultz. Teva shares have surged 76.3% over the last three months, compared with a 3.4% rise in the S&P 500 SPX, -0.54%
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>>> Elbit Systems Ltd. is an international technology company engaged in a range of programs across the world. The Company develops and supplies a portfolio of airborne, land and naval systems and products for defense, homeland security and commercial aviation applications. Its systems and products are installed on new platforms, and it also performs platform modernization programs. In addition, it provides a range of support services. The Company's activities include military aircraft and helicopter systems; helmet mounted systems; commercial aviation systems and aerostructures; unmanned aircraft and unmanned surface vessels; land vehicle systems; command, control, communications, computer and intelligence (C4I) systems; intelligence and cyber systems; electro-optic and countermeasures systems; electronic warfare and signal intelligence systems, and various commercial activities. It operates primarily in the defense and homeland security arenas. <<<
>>> Ormat Technologies, Inc. is a holding company, which engages in the provision of renewable energy. It operates through the Electricity and Products segments. The Electricity segment develops and installs geothermal power plants. The Product segment manufactures and sells equipment for energy-based electricity generation, remote power units and power generating units. The company was founded in 1965 and is headquartered in Reno, NV. <<<
>>> BiondVax Pharmaceuticals Ltd., a clinical stage biopharmaceutical company, focuses on developing and commercializing immunomodulation therapies for infectious diseases primarily in Israel. Its product candidate includes M-001, a synthetic peptide-based protein, which is in Phase II clinical development stage targeting seasonal and pandemic strains of the influenza virus. The company was founded in 2003 and is based in Ness Ziona, Israel. <<<
BiondVax - >>> BVXV: Immunogenicity Results From Phase 2b Trial of M-001 Expected Soon…
Zacks Small Cap Research
June 02, 2017
By David Bautz, PhD
https://finance.yahoo.com/news/bvxv-immunogenicity-results-phase-2b-170000664.html
NASDAQ:BVXV
Financial Update
On May 30, 2017, BiondVax announced financial results for the first quarter of 2017. As expected, the company did not report any revenues during the quarter. The company reported a net loss of $3.2 million for the first quarter of 2017, which was comprised of $0.5 million in R&D expenses and $0.3 million in G&A expenses. Total cash burn for the first quarter of 2017 was approximately $0.65 million.
As of March 31, 2017, BiondVax had cash, cash equivalents, and marketable securities of $9.6 million. On January 2, 2017, BiondVax announced that Angels High Tech Investments Ltd., which is owned by Marius Nacht (co-founder of Check Point Software Technologies Ltd. [Nasdaq: CHKP]), had agreed to invest approximately $2.83 million in the company in exchange for 844,000 Nasdaq listed ADS. Following the transaction, Angels Investments holds 19.99% of all issued and outstanding shares of the company. An investment such as this is important as it shows a level of confidence in both M-001 and the BiondVax management team as well as providing the company with much needed capital to continue development of M-001 into Phase 3 clinical trials. Lastly, the added financial stability provided by the investment could make it easier for the company to pursue grants and other non-dilutive funding sources.
BiondVax Publishes Regulatory Approval Strategy for Universal Influenza Vaccines
On March 13, 2017, BiondVax Pharmaceuticals Ltd. ( BVXV) announced the publication of an article written by BiondVax-affiliated authors titled, “Strategy for approving a universal flu vaccine” in the journal Future Virology (Ben-Yedidia et al., 2017). The authors discuss the strategy to get M-001 through the regulatory process by using a stepwise approach that first utilizes an existing regulatory marker before using newly defined markers.
Currently, the efficacy of all seasonal influenza vaccines is tested based on induction of hemagglutination inhibition (HAI) antibodies that target the outer variable regions of the viral hemagglutinin protein. Since M-001 is targeted against conserved regions of the influenza virus, it does not elicit HAI antibodies but instead induces a cellular response. Thus far, BiondVax has taken the conservative approach of using M-001 as a primer to be given ahead of the seasonal influenza vaccine. This has allowed the HAI antibody response to continue to be used to verify the efficacy of M-001. When given has a primer, M-001 enhances and broadens the HAI antibody response induced by the seasonal influenza vaccine.
One possible path forward that the company is considering is to conduct two Phase 3 clinical trials to support approval of M-001 as a primer vaccine. One Phase 3 study would likely focus on the use of M-001 as a primer for seasonal vaccination in the elderly, while another Phase 3 study would focus on the use of M-001 as a primer for pandemic immunization for approval to be stored in the national stockpile. According to the article by Ben-Yedidia et al., regulatory agencies have suggested 3,000 participants in the experimental group and 1,500 in the placebo group. Assuming a 10% drop out rate leads to a total of approximately 5,000 individuals in total for those studies.
The primer vaccine trials will continue to employ the serum HAI titer as an efficacy outcome, which will be measured on Day 0 and 42. Success will be measured as a seroconversion response of ≥10% to at least two of the trivalent influenza vaccine (TIV) strains and noninferiority to the third TIV strain. This outcome was accepted by the FDA for the Sanofi Fluzone High Dose vaccine marketing authorization.
If BiondVax were to seek approval as a primer vaccine in the elderly first, it would likely be followed up by Phase IV clinical trials being conducted with M-001 as an independent, stand alone influenza vaccine. These trials will need to include tens of thousands of participants with an efficacy endpoint of reduction of influenza illness rate and severity with M-001 compared to those immunized with the seasonal vaccine.
BiondVax is planning to apply for an FDA-accelerated approval pathway that could lead to approval based on a limited-size Phase 3 clinical trial, such as the planned trial in the elderly to test M-001 as a primer to the seasonal vaccine.
We believe the plan as set forth in the article by Ben-Yedidia et al. for gaining regulatory approval for M-001 is a sound one. The plan is likely to prove successful as the company already has a large amount of data showing the ability of M-001 to induce a greater immune response in patients when used as a primer compared to those who are only given the seasonal influenza vaccine. In addition, it allows regulatory agencies the opportunity to get comfortable with a new type of influenza vaccine through its use as a primer, and to collect an abundance of real-world efficacy and safety data before considering it as a stand alone vaccine.
BiondVax Approved for Grant to Help Construct Manufacturing Facility
On March 30, 2017, BiondVax Pharmaceuticals Ltd. (BVXV) announced that the Israeli Ministry of Economy and Industry approved a grant to cover 20% of the NIS 20 million budget for construction of a manufacturing facility for M-001. The facility will be used to produce sufficient quantities of vaccine for Phase 3 clinical trials and commercialization. BiondVax is planning to construct a mid-sized facility in Jerusalem that could potentially one day produce tens of millions of doses of M-001.
Background on M-001
BiondVax is developing the M-001 vaccine, a synthetic peptide-based protein that targets both existing and future seasonal and pandemic strains of the influenza virus. The vaccine targets conserved regions of Type A and B influenza viruses such that M-001 could be considered a “universal” influenza vaccine, capable of offering immunological protection against all strains of the influenza virus.
The company is planning to seek regulatory approval through a two-part strategy:
1. As a “Universal Primer” to be used before any hemagglutinin-based flu vaccine. BiondVax targets two indications for its universal primer: i) seasonal primer for influenza vaccine in the elderly, and ii) pandemic primer for national stockpile.
2. As a stand-alone independent “universal” vaccine against influenza.
Many infectious diseases have been eradicated over the past century, for example polio and smallpox, thanks to vaccination. In order to eradicate an infectious disease, a community (or herd) immunity must be achieved. Three conditions are required to achieve community immunity:
1. An effective vaccine,
2. Broad coverage and unchanging vaccine formulation, and
3. Enough people to be vaccinated.
With a universal flu vaccine such as BiondVax’s M-001, it appears theoretically possible, for the first time in history, to achieve the goal of influenza eradication. In support of this, the company was recently invited to attend the “Eighth WHO meeting on the development of influenza vaccines that induce broadly protective and long-lasting immune responses”. The Global Vaccine Action Plan (GVAP) has a goal for at least one universal influenza vaccine to be on the market by 2020, and the World Health Organization (WHO) is supporting this initiative through constant interaction with leading experts in the field through events such as the one BiondVax will be attending. M-001 is a leading contender to be the first universal influenza vaccine due to its safety profile and strong immunogenicity along with currently being in Phase 2b clinical trials.
M-001 Composition
M-001 is composed of nine peptides that are believed to be common to most known influenza strains in existence, in part because these peptides seem to be critical for the virus’ ability to infect a host cell. They are derived from hemagglutinin (HA), matrix 1 (M1) and nucleoprotein (NP) viral proteins and are arranged as triplicates into a single recombinant protein easily manufactured in bacteria. As discussed above, HA is an antigenic glycoprotein found on the surface of influenza viruses and is also the main constituent for a number of seasonal influenza vaccines. However, the peptides from HA in M-001 are derived from the inner parts of the protein where little to no variability between strains exists. M1 is a matrix protein that forms a layer under the patches of the viral cell membrane that contain HA, NA, and M2 proteins, and is responsible for mediating the encapsulation of RNA-nucleoprotein complexes into the membrane envelope (Sha et al., 1997). NP is a structural protein that encapsidates the viral RNA inside the virus. The sequence of each of the peptides is shown below, along with the order in which the peptides are arranged in the full-length recombinant protein.
The peptides were selected based upon their ability to elicit either a B- or T-cell immune response and each of them has the ability to bind to a wide array of human leukocyte antigen (HLA) proteins (both Class I and Class II), which are responsible for presenting peptides to the immune system. Some may question the use of peptides from proteins located inside the virus, however there is a strong rationale for their use. It has long been known that a mild influenza infection in animals provides protection against a subsequent, more severe challenge with a virus harboring different HA and NA (Yetter et al., 1980). This effect appears to be mediated by both CD4+ and CD8+ T-cells that recognize conserved regions on viral proteins (Furuya et al., 2010). The CD4+ T-cells that are specific for conserved internal viral antigens also potentiate antibody responses to the HA of subsequently encountered viruses (Scherle et al., 1986). The end result is that immunizing with conserved internal viral antigens results in an increased immunological response to infection following subsequent exposure to influenza viruses.
M-001 Clinical Trial Results
Thus far, M-001 has been tested in 479 participants through five different clinical trials, with the details presented in the following chart. In each of the trials, the vaccine was shown to be safe and able to induce a robust immune response. Due to the fact that M-001 does not target the variable region of HA, the HAI assay (which is utilized to test the effectiveness of currently available seasonal influenza vaccines) cannot be employed as a surrogate endpoint for determining vaccine efficacy when M-001 is administered on its own. Thus, the company has developed additional immunological assays to determine immunogenicity. In addition, in its first stage in bringing M-001 to market, the company is pursuing a “prime-boost” strategy, where M-001 is given prior to immunization with the traditional seasonal influenza vaccine, in which case the HAI assay can be utilized to compare immunogenicity to currently available influenza vaccines. The trials completed thus far are presented below.
Final Phase 2 Clinical Trials for M-001
BiondVax has initiated two Phase 2 clinical trials that will involve a total of 372 participants; one that has completed in Europe (BVX-007) and one that will soon start admitting participants in the U.S. (BVX-008).
BVX-007: The BVX-007 trial was a Phase 2b clinical trial with 219 adults (age 18-60) who have completed the study. It was designed to evaluate the safety and immunogenicity of M-001 when used as a primer to the H5N1 avian influenza vaccine. The H5N1 avian influenza vaccine was given once, at a sub-optimal dose, in order to test whether M-001 can enhance its immunogenicity.
On November 29, 2016, Biondvax Pharmaceuticals, Ltd. (BVXV) announced positive preliminary safety results from the BVX-007 trial. Since the data is still blinded, the distribution of adverse events amongst the total of 219 participants who completed the study in the control and experimental groups is unknown. However, only three moderate adverse events were considered to be possibly or probably related to treatment and no treatment-related serious adverse events were reported.
If successful, this trial could show the dose sparing potential of M-001, which in the case of a pandemic situation could allow for the available doses of pandemic vaccine to be administered to more subjects. The trial is being funded through a grant from the European Union and is being conducted in conjunction with the European UNISEC Consortium. We anticipate immunogenicity results from this trial will be reported near the end of the second quarter of 2017.
BVX-008: This will be a Phase 2 clinical trial being conducted by the NIAID, which is part of the NIH. The double blind, multicenter, randomized, placebo controlled trial is expected to enroll 150 adults (18-45) and will examine the use of M-001 as a primer vaccine to be given several weeks before the H7N9 avian pandemic vaccine. The primary outcome will be safety and tolerability with secondary endpoints examining humoral and cellular immune responses. We anticipate this trial will begin in the next few months with results available in 2017.
Valuation Methodology
We value BiondVax using a probability adjusted discounted cash flow model that takes into account potential revenues from the sale of M-001 as 1) a seasonal primer for influenza vaccine in the elderly; 2) a pandemic primer for a national stockpile; and 3) a stand-alone independent universal influenza vaccine. At this point, we are assuming that the company will enter into one or more partnerships with larger pharmaceutical companies that will result in BiondVax receiving royalties (we model 15% for all indications) on the sale of M-001.
In the U.S., there were approximately 135 million doses of the influenza vaccine administered last year with approximately 20% of those administered to the elderly. Assuming a 33% penetration rate which will use M-001 as part of prime-boost vaccine, then at approximately $20 per dose (based on a midpoint between the Fluzone HD geared to the elderly price of $28 and the standard Fluzone price of $8 per dose) it is a potential $200 million opportunity just in the U.S. We believe the rest of the world represents a potential $300 million peak opportunity. We apply an 18% discount rate and a 50% probability of approval to arrive at a net present value for M-001 as a primer for seasonal vaccination in the elderly of $49 million.
Another market is the pandemic primer for national stockpile. The critical workforce in the U.S. is approximately 15% of the population (20 million people), and 1/3rd of the stockpile is replaced annually (given a shelf-life of three years). At $12 per dose that represents another $240 million annual opportunity. We apply an 18% discount rate and a 50% probability of approval to arrive at a net present value for M-001 as a primer for a pandemic vaccine of $40 million.
As a stand-along universal vaccine, we anticipate Phase 3 trials initiating in 2019 with a regulatory filing in 2021 and approval in 2022. By that time we model for approximately 140 million doses of the influenza vaccine being administered in the U.S., and with a peak market share of 25%, we model for peak revenues of over $700 million. We apply an 18% discount rate and a 33% probability of approval to arrive at a net present value for M-001 as a stand-along universal vaccine of $43 million.
Combining the net present value for each of the company’s development programs along with the company’s current cash total and expected operating burn leads to a valuation of approximately $18 per share.
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>>> Mazor Robotics Ltd., together with its subsidiaries, engages in the development, production, and marketing of medical devices for supporting surgical procedures in the fields of orthopedics and neurosurgery in the United States and internationally. The company operates in the field of image guided surgery and computer assisted surgery that enable the use of surgical instruments with high precision and minimal invasiveness. It offers Mazor X surgical guidance system and Renaissance surgical guidance system that transform spine surgery from freehand procedures to guided procedures. The company was formerly known as Mazor Surgical Technologies Ltd. and changed its name to Mazor Robotics Ltd. in 2010. Mazor Robotics Ltd. was founded in 2000 and is based in Caesarea, Israel. <<<
>>> How Teva Is Fighting (and Losing) the Big Pharma Battle
By Craig Adeyanju
May 25, 2017
http://www.investopedia.com/news/teva-fighting-losing-big-pharma-battle/
In a 2010 edition of the “World Preview Report” published by the pharmaceutical research team at Evaluate, it was estimated that Israel’s Teva Pharmaceutical Industries (TEVA) would grow its worldwide prescription annual sales by roughly 7%, from $12.6 billion in 2009 to $20.8 billion by 2016. In January 2010, Teva itself announced a goal of generating $31 billion in revenue by 2015. The optimistic projection was simply because Teva, being a leader in the generics market, was well positioned to benefit from a massive patent cliff that was imminent at the time. The generic drug giant estimated that branded products with sales of about $150 billion, as of 2010, would lose their patents by 2015. (For related reading, see: Analysts Slash Teva Ratings.)
The Israeli drug maker’s revenue reached a peak of roughly $20.32 billion in 2012 and declined every year until 2015 when it reported a revenue of roughly $19.65 billion. Teva’s only revenue growth since 2012 came in 2016 when it reported revenue of roughly $21.9 billion. The story of how Teva is fighting – and losing – against big pharma lies in the fact that it missed the target it set for itself, despite the said patent cliff actually hitting big pharmaceuticals.
Pfizer, for instance, saw its revenue dip between 2011 and 2015 because of the expiration of certain key patents. In another sign of a reversal of the trend, pharmaceutical analysts at Evaluate, which had estimated that Teva’s global prescription drug market share would grow from 2% in 2009 to 2.7% in 2016, re-estimated in a 2016 report that the drug maker’s prescription drug market share would plummet from 2.3% in 2015 to 1.6%. So what happened to Teva’s $31 billion dream?
Teva's Questionable Generic Drug Moves
At the time Teva set a target of $31 billion in revenue by 2015, the company was working with a seven-point growth strategy, one point of which was to increase its market share. To achieve that, the company made a number of acquisitions.
In 2010, Teva acquired German pharmaceutical company Ratiopharm for $5 billion, a deal which made Teva Germany’s largest generic drug maker. In the fourth quarter of 2010, the acquisition of Ratiopharm made the Israeli drug maker’s sales in Europe grow by 43%. In 2011, the drug maker continued its acquisition spree with the acquisition of U.S. biopharmaceutical company Cephalon in a $6.8 billion deal and a 57% stake in Japanese generic drug company Taiyo Pharmaceutical for $460 billion. Taiyo, at the time, was the third largest generics drug maker in Japan—the world’s second largest drug market after the U.S. It also acquired the 50% interest held by Japan’s Kowa Co. in the Teva-Kowa joint venture initiated in 2008. At the time, Teva-Kowa Pharma Co. was one of the top five generic drug makers in Japan with sales of $200 million in 2010.
One of the reasons Teva upped its acquisition game at the time was to diminish its dependence on its blockbuster multiple sclerosis drug Copaxone, which was to lose patent protection in 2014. It was only logical to grow its generic drug business ahead of the then impending patent cliff in the pharmaceutical industry to grow its business. However, even in its peak revenue year of 2012, Copaxone accounted for 20% of its revenue, compared to 16% in 2011. By contrast, its generic drug business accounted for 51% of its revenue, down from 52% in 2011.
The Israeli company first suffered a setback in 2011 when the U.S. raised quality assurance concerns at the drugmaker’s Jerusalem plant, an event that saw the company’s generic drug sales in the U.S. dip by over 30% in 2011. The U.S. is Teva’s biggest generic drug market. Despite acquiring Actavis Generics from Allergan Plc (AGN) in 2016, it only grew its generic drug sales by roughly 2.7%, on a CAGR basis, between 2011 and 2016. Considering that the company was eyeing a sizable chunk of the estimated $150 billion in branded drug sales that were to lose patent protection by 2015, a 2.7% CAGR growth rate isn’t impressive. (For more, see also: TEVA's Ever-Narrowing Margin for Error.)
Actavis Generics Criticism
The aforementioned acquisition of Allergan’s generics unit Actavis Generics, in a $41 billion deal, has also been under scrutiny by investors. Teva had signaled that, in addition to using the deal to grow its generics market share, it intends to leverage Actavis’ assets to develop complex generics. Complex generics are considered more profitable given that they’re harder to copy. Still, a report in the Financial Times, published on May 29, 2016, quoted an unnamed Teva investor as saying the Israeli company overpaid for Actavis by around 25%.
Another investor said Teva was aiming to grow its generics business at a wrong time, saying the company should have put the acquisition cash toward the development of branded medicines, which are more profitable and face less competition. The problem is compounded by the fact that the deal pushed the drug maker’s total long-term debt from around $9.943 billion at the end of 2015 to around $35.80 billion by the end of 2016.
Putting it all together, Teva, while still the largest generics drug maker in the world, has been struggling to catch up with big pharmaceuticals because of its unrelenting desire to grow its generics business, when a focus on branded medicines could have helped.
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Mobileye - >>> How to Think About the Race to Self-Driving Cars
Here's a better way for investors to think about profiting from this transformative technology.
John Rosevear
Jan 24, 2017
http://www.fool.com/investing/2017/01/24/how-to-think-about-the-race-to-self-driving-cars.aspx?source=yahoo-2&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2
Alphabet's Waymo is one of several companies inside and outside of the traditional auto industry working to bring a self-driving solution to market. Image source: Fiat Chrysler Automobiles.
Who will win the "race" to a self-driving car?
That's a question lots of investors seem to be asking. It's not hard to understand why: Self-driving cars could transform the way many of us get around, and transformative new technologies tend to offer big profit opportunities for those who are able to see them coming.
Recently, a Foolish colleague asked me to come up with some sort of metric that might help us judge the likely "winners" in the race to self-driving cars, at least among automakers. But after some thought, I decided it's not so simple -- and that the idea of "winners" might not be the right way to think about things when it comes to self-driving technology, at least in the near term.
Why it's hard to tell who is in the best position to profit big
Lots of companies in, around, and outside of the traditional auto industry are working on autonomous vehicle (AV) or "self-driving" technology. Some, like Tesla Motors (NASDAQ:TSLA) are somewhat open about where they are in the development process and when they hope to have something on the market.
But others aren't. Among established automakers and their suppliers, details of upcoming new products and technologies have traditionally been held very tightly, kept secret until a few months before launch.
Take the example of General Motors (NYSE:GM), which is probably among the leaders in developing AV technology. We know that GM acquired self-driving start-up Cruise Automation last year and that the new electric Chevrolet Bolt is its "platform" (GM's word) for testing AV technology.
Gm Autonomous Fleetvehicle Testing In michigan
A prototype self-driving Chevrolet Bolt undergoing testing near GM's technical center in Warren, Michigan. Image source: General Motors.
We also know that GM has been working on a not-quite-autonomous system called "Super Cruise" that is comparable to Tesla's Autopilot, and that Super Cruise has been expected to debut as an option on a Cadillac sometime this year (although that's not certain).
But we don't know when GM will bring so-called Level 4 AV technology, a system that can provide full autonomy under some (but not all) circumstances, to market -- or how widely GM will roll it out, or even how it will roll out. Will it be an option on luxury Cadillacs, a self-driving Bolt built specifically for ride-hailing duty, or something else entirely? (Level 5 systems that can drive anywhere a human driver could are thought to be much further off.)
The same goes for most of the other automakers: We don't know exactly where their technology is, how much they're spending, or when (or how) they intend to bring it to market. Will they use an off-the-shelf system provided by traditional industry suppliers, or will they develop a customized, more deeply integrated solution in-house (as GM appears to be doing)?
And we certainly can't tell right now how the different systems under development are likely to stack up -- or how the market will receive them.
We can make some broad guesses as to when Level 4 technology will come to market, and as to who is likely to be among the first to bring it to market. But as you'll see, that's not necessarily helpful to us as investors: It's likely that Level 4 technology will be a commodity not long after the first Level 4 vehicle comes to market.
Why self-driving technology will quickly become a commodity
Here's the thing that many investors seem to miss: It looks very likely the entire incumbent auto industry will have access to Level 4 technology before long. Giant auto supplier Delphi (NYSE:DLPH), assisted-driving specialist Mobileye (NYSE:MBLY), and chip giant Intel are working together on a Level 4 system that they promise will be available to any automaker that wants it by the end of 2019.
It will probably be another year or more after that date before the first new cars with those systems go into production. But at some point, likely by 2021 or so, Level 4 technology will be a commodity: Several other companies are known to have rival systems under development.
That doesn't mean that all new cars will offer self-driving capabilities by 2021. The systems will probably be still expensive enough that they'll only make sense for luxury cars and commercial vehicles (which might include vehicles built for ride-hailing services).
They'll also be geographically limited, and they may be limited by road conditions (think snow and ice) as well. But the maps will expand quickly, capabilities will improve as more cars rack up miles (and data), and the prices of the systems' sensors and other components will drop as more are made. Assuming that it follows the pattern set by many other new automotive technologies over the years, Level 4 systems will gradually become more widely available as costs drop.
Long story short: Level 4 technology will probably be offered on most new vehicles in the U.S. within a decade -- and established auto-industry suppliers will be in a position to supply it.
Why it doesn't make sense to think in terms of "winners" yet
"So what if," I asked my Foolish colleague, "Tesla brings a Level 4 system to market in 2019 -- but then by 2021 or so, any automaker can buy its roughly comparable technology off the shelf from existing industry suppliers? Does Tesla 'win'?"
I think in such a scenario, Tesla would certainly win bragging rights. That's not nothing: Bragging rights on new technology add value to Tesla's brand in a way that they might not for a big automaker.
But Tesla is only likely to be able to make 500,000 or so cars a year in 2019 and 2020, and that's if all goes well with its upcoming Model 3. That's not anywhere near enough to dominate the global auto market -- it's not really even enough to dominate the luxury-car market in the U.S., Europe, and China. (And if the Model 3 is anywhere near as good as Tesla fans expect, Tesla will be selling all it can make anyway -- with or without a Level 4 system available.)
And of course the Delphi-Mobileye-Intel system will probably have other competition by 2021, so we can't quite declare that group to be the likely "winner" either, at least not yet.
So where does this leave us as investors?
Good question. It's one that I've been struggling to answer for a while.
Right now, the closest thing to a "pure play" investment in autonomous driving (among public companies, at least) is probably Mobileye. Mobileye is a profitable business with an enviable client list (nearly all of the world's automakers do business with Mobileye), But it's currently trading at over 100 times earnings, and it's not clear that it will have the earnings growth it will need to reward investors who buy at this valuation.
Meanwhile, an investment in a company like Delphi or GM -- or Alphabet (NASDAQ:GOOG) (NASDAQ:GOOGL) and its Waymo self-driving unit -- is far from a "pure play." Sure, AV technology could turn out to be a profitable business for any, but it's not likely to be transformative (at least, not in a good way) for any of them. But that said, it's possible (likely, really) that some companies will come up with ways to differentiate their offerings that allow them to win more market share or profit.
Here at the Fool, we're encouraged to give our readers an "actionable takeaway," an investment idea to research or a thought that could help you become a better investor. When it comes to self-driving technology, my takeaway for you is this: There are no obvious winners now, but there might be once we see how the technology is coming to market
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>>> Mobileye N.V., together with its subsidiaries, develops computer vision and machine learning, data analysis, and localization and mapping for advanced driver assistance systems and autonomous driving technologies primarily in Israel. It operates through two segments, Original Equipment Manufacturing and After Market. The company offers Roadbook, a localized drivable paths and visual landmarks using its proprietary REM technology through crowd sourcing; and proprietary software algorithms and EyeQ chips that perform detailed interpretations of the visual field to anticipate possible collisions with other vehicles, pedestrians, cyclists, animals, debris, and other obstacles. Its products also detect roadway markings, such as lanes and road boundaries, as well as barriers and related items; and identify and read traffic signs, directional signs, and traffic lights. In addition, the company provides enhanced cruise control, pre-lighting of brake lights, and Bluetooth connectivity, as well as related smartphone application. It serves original equipment manufacturers, tier 1 system integrators, fleets and fleet management systems providers, insurance companies, leasing companies, and others through distributors and resellers. Mobileye N.V. was founded in 1999 and is headquartered in Jerusalem, Israel. <<<
Opko Health - >>> It's Full Speed Ahead for Opko Health After Pipeline Stumble
Opko Health talks about its momentum and a second chance for its human growth hormone at the J. P. Morgan Healthcare Conference.
Keith Speights
Jan 12, 2017
http://www.fool.com/investing/2017/01/12/its-full-speed-ahead-for-opko-health-after-pipelin.aspx?source=yahoo-2&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2
Mark Twain and an experimental human growth hormone?
Opko Health (NASDAQ:OPK) executive vice president Steve Rubin managed to combine this unlikely pair at the J. P. Morgan Healthcare Conference on Wednesday. Rubin talked about the recent clinical failure of a human growth hormone, hGH-CTP, that Opko is developing in partnership with Pfizer (NYSE:PFE). He said that he knew he might be badly misquoting Mark Twain, but emphasized that "rumors of its demise are greatly exaggerated." Rubin said that Opko is moving "full steam ahead." Here's how.
Full Speed Ahead
Image source: Getty Images.
Possible culprit found
Opko announced on Dec. 30, 2016, that the primary endpoint wasn't met in a late-stage study of experimental long-acting human growth hormone product hGH-CTP in adults. Based on earlier clinical trials, the company expected to find significant reduction in trunk fat mass in patients receiving hGH-CTP, compared to the placebo group. That didn't happen.
In its initial announcement of the disappointing results, Opko hinted at something potentially suspicious with the data, saying that it had "identified one or more outliers that may have affected the primary outcome." Steve Rubin revealed on Wednesday what the outlier was.
Rubin said that the company's scientists discovered "an exceptional value of trunk fat mass reduction in the placebo group." What this means in terms of next steps is that Opko will take another swing at evaluating treatment in the adult patient population. The company's team recently finalized a plan to move forward with Pfizer, which is responsible for registering and potentially commercializing hGH-CTP.
Opko and Pfizer must get a go-ahead from the U.S. Food and Drug Administration first, of course. However, based on what Rubin said, it doesn't sound like the companies are cherry-picking the data to improve their case. He expects that a statistical analysis of data will be initiated and expressed optimism that hGH-CTP will ultimately be submitted for approval in treating adults.
More momentum
Rubin also highlighted several other programs that are picking up steam. Opko continues to work to secure reimbursement arrangements with payers for its 4Kscore prostate cancer test. The company has obtained a positive coverage decision from one national payer. Opko is talking with several Medicare administrative contractors (MACs) and now feels confident that it has the data to support positive local coverage determinations by any MAC.
Opko kicked off a clinical study for its Claros 1 prostate-specific antigen (PSA) test just a few days ago. Rubin said that the company expects to file for modular pre-market approval of the PSA test in the first half of this year, with a testosterone test 510(k) filing coming in the second half of 2017.
The launch of secondary hyperparathyroidism drug Rayaldee is also gaining momentum. Opko has secured contracts with commercial and Medicare Part D payers to cover over half of all Americans. The company thinks that between 70% and 80% of individuals will be covered for Rayaldee by mid-2017.
Opko also anticipates some solid pipeline progress this year. Top-line data from a phase 2a study evaluating its long-acting FVIIa replacement therapy for hemophilia patients should be announced in the first half of 2017. Opko plans to begin a phase 2b clinical study of oxyntomodulin in treating type 2 diabetes in the second half of the year.
Running out of steam?
The failure of hGH-CTP resulted in Opko's losing over 20% of its market cap overnight. Even before that disappointment, Wall Street analysts appeared to be losing some of their enthusiasm about the stock. Although Steve Rubin says that it's full steam ahead, is Opko actually running out of steam?
My view is that it isn't. I think Opko will win over more payers for 4Kscore and get some good news from Rayaldee this year. BioReference Labs should also keep going strong.
We still don't have enough information to have a warm-and-fuzzy feeling about the prospects for hGH-CTP in treating adult patients, though. Rubin's update provided some hope for the human growth hormone. It could conceivably still be a big success for Opko and Pfizer if his confidence is warranted. Of course, there's always the possibility that Rubin's optimism is just (wait for it)...hot air.
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Amdocs Ltd | DOX | 7.61% |
NICE Ltd | NICE | 7.33% |
Check Point Software Technologies Ltd | CHKP | 6.92% |
Mellanox Technologies Ltd | MLNX | 6.31% |
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Electra Consumer Products Ltd | ECP | 2.20% |
Cellcom Israel Ltd | CEL | 2.12% |
Kornit Digital Ltd | KRNT | 2.09% |
Danel (Adir Yeoshua) Ltd | DANE | 2.03% |
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DarioHealth Corp | DRIO | 2.01% |
Allot Ltd | ALLT | 2.00% |
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Wix.com Ltd | WIX | 8.50% |
Bank Leumi Le-Israel BM | LUMI | 7.75% |
NICE Ltd | NICE | 7.07% |
Check Point Software Technologies Ltd | CHKP | 6.70% |
Bank Hapoalim BM | POLI | 6.30% |
Teva Pharmaceutical Industries Ltd ADR | TEVA | 5.23% |
Israel Discount Bank Ltd Class A | DSCT | 3.67% |
CyberArk Software Ltd | CYBR | 3.56% |
Fiverr International Ltd | FVRR | 3.43% |
ICL Group Ltd | ICL | 3.34% |
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Wix.com Ltd | WIX | 5.73% |
SolarEdge Technologies Inc | SEDG | 5.44% |
NovoCure Ltd | NVCR | 5.39% |
NICE Ltd ADR | NICE | 5.29% |
Check Point Software Technologies Ltd | CHKP | 5.22% |
Bank Leumi Le-Israel BM | LUMI | 5.07% |
Teva Pharmaceutical Industries Ltd ADR | TEVA | 4.27% |
Bank Hapoalim BM | POLI | 3.76% |
Amdocs Ltd | DOX | 3.71% |
Fiverr International Ltd | FVRR | 3.33% |
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