Top Stores for Week of March 16, 2020

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Europe now the epicenter of coronavirus pandemic: WHO.

Europe has now become the epicenter of a coronavirus pandemic that has claimed 5,000 lives around the world, “a tragic milestone,” the World Health Organization said on Friday. More than 132,000 cases of the virus have been reported in 123 countries since it emerged in December in the central Chinese city of Wuhan, WHO director-general Tedros Adhanom Ghebreyesus told a virtual news conference.

“Europe has now become the epicenter of the pandemic with more reported cases and deaths than the rest of world combined apart from China,” he said in Geneva.

Tedros announced that WHO was launching a coronavirus solidarity response plan. This would allow people and organizations to contribute to help fund masks, gloves, gowns and goggles for health workers, as well as diagnostic kits and investment in research and development, including for vaccines.

Social distancing is a “tried and tested method” to slow the spread of a virus but “not a panacea” that will stop transmission, WHO’s top emergency expert Dr. Mike Ryan said. Each sovereign country must decide on its own measures to protect its own population, Ryan said, adding:

“But we’ve also consistently said that blanket travel measures in their own right will do nothing to protect an individual state.”

Detection and isolation of infected people as well as tracing their contacts and wider testing must be part of a comprehensive strategy, Ryan said.

“As part of an overall comprehensive strategy, there is a place–particularly inside national borders–for potentially restricting movement between zones, as we’ve seen in certain places,” he said. “But there is rarely a justification for blanket bans, unless of course the context and the risk defines that.”

Meanwhile, US President Donald Trump announced sweeping travel restrictions to prevent people from 28 European countries from traveling to the US in a bid to limit the virus spread. A number of other countries in recent days have announced stepped up border checks, and canceled flights to other countries, in an effort to contain the spread.

Trump on Friday (March 13, 2020) declared a national emergency over the fast-spreading coronavirus, opening the door to providing more federal aid to fight the disease, according to Reuters.

COVID-19 Addenda

At a news conference on Saturday, President Trump announced that he had been tested for the coronavirus on Friday (March 3, 2020) night and was awaiting the results. Whether the President would be tested had been a matter of speculation since it first emerged that a member of a Brazilian delegation that visited Mar-a-Lago had tested positive. Two other people who were with the President at Mar-a-Lago have tested positive, and various members of Congress have been self-isolating after interacting with some of the same people.

The US Centers for Disease Control and Prevention (CDC) on Friday (March 3, 2020) reported 1,678 cases of the coronavirus, an increase of 414 cases from its previous count, and said that the number of deaths had risen by 5 to 41. The agency said the cases had been reported by 46 states and the District of Columbia, up from its previous report of 42 states and the District of Columbia. The CDC tally includes 49 cases among people repatriated from Japan and Wuhan, China, where the outbreak began. The figures do not necessarily reflect cases reported by individual states.

Medical Stock Spotlight: Although last week ended with some decent gains in the health sector, Monday’s (March 16, 2020) return to freefall dashed hopes for a return to sanity and profits.

  • Thinly traded nano cap Tiziana Life Sciences PLC (Nasdaq: TLSA) is the latest coronavirus play. The London-based company saw its shares rocket 58% over the week to $3.34 after announcing that its TZLS-501 treatment could be a potential treatment for patients infected with coronavirus (COVID-19) who are at risk of respiratory failure. Tiziana, a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, is expediting development of TZLS-501 with partner Novimmune SA, a Swiss biotechnology company. Tiziana plans to administer TZLS-501, an interleukin 6 (IL-6)-inhibiting monoclonal antibody, using a proprietary formulation technology. Tests have already shown that the treatment rapidly depletes circulating levels of IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness. Monday, shares plunged 33% to $2.24.
  • Elsewhere, OraSure Technologies Inc. (Nasdaq:OSUR) shot up 27% to $7.54. Based in Bethlehem, PA, OraSure bills itself as “a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. These products include tests for the detection of antibodies to the HIV virus.” Investors are betting this name will be a prominent candidate for development of much-needed test kits for the coronavirus. This week, shares started down 7% to $7.03.
  • But included in the broader market crash, Tilray Inc. (Nasdaq:TLRY) plunged 60% to $4.03. Investors did not take kindly to Nanaimo, Canada-based Tilray’s latest effort at raising capital. The company is offering 7.25 million shares of its common stock plus 11.75 million warrantsto purchase same for those who don’t want to opt for the shares just now. Each stock or warrant comes with one “accompanying” warrant. The price is $4.76 per share/warrant plus accompanying warrant, quite some distance below the previous day’s closing price. The marijuana company said it expects the issue to close on Tuesday, March 17. Share issues are relatively typical in the marijuana industry, as many companies in the sector habitually post losses. Lately, when issuing stock, some companies have offered “sweeteners” like Tilray’s accompanying warrants. The dilution bug continued to bite with shares closing Monday down another 24% to $3.07.
  • Rubius Therapeutics Inc. (Nasdaq:RUBY) tumbled 51% to $3.82 after announcing it will end development of its most advanced drug. Simply put, the Cambridge, MA-based biotech is looking to save money by moving away from rare disease research. The decision, according to Rubius, is partially due to setbacks that hurt its lead drug, an experimental treatment for the uncommon metabolic disorder phenylketonuria, or PKU. An early study of the drug had a delayed start, and then results from the first patient were “uninterpretable,” the biotech said. Rubius expects the costs saved by shuttering its rare disease programs will give it enough cash to operate into 2022.​ In the meantime, the company will focus resources around cancer and immune system drugs. Those include RTX-240, a cell therapy for solid tumors that was recently cleared for human testing. Unlike its other health-sector brethren, shares recovered 13% Monday to $4.32.
  • And biotech Inovio Pharmaceuticals Inc. (Nasdaq:INO) plummeted 49% to $7.20 as analysts weighed in on the company’s latest earnings and RBC downgraded the stock on valuation grounds. The Plymouth Meeting, PA–based company has seen its stock soar more than 180% this year, as the company announced that it’s developing a vaccine called INO-4800 to treat COVID-19. The vaccine is currently in preclinical studies, and the company is aiming to advance to clinical trials in April. But Thursday’s earnings call may have reminded investors that the company is still a small biotech with many products in development but none that are actually approved. Inovio posted a net loss of $37.7 million, or 38 cents a share, for the fourth quarter, wider than the $33 million, or 34 cents a share, loss posted in the year-earlier period. Revenue was a mere $279,000, down from $2.5 million a year ago. RBC analyst Gregory Renza downgraded the stock to sector perform from outperform on Friday. Monday saw no rebound and instead shares dropped another 16% to $6.05.

IPO Sector: Markets may be crashing around the world, but the US IPO scene is still seeing pricings and new registrations. Here’s last week’s action:

  • Imara Inc., a Phase 2 biotech developing small molecule therapies for rare genetic disorders, like sickle-cell disease, raised $75 million by offering 4.7 million shares at $16, the low end of the range of $16 to $18, to command a $286 million fully diluted market cap. Backed by NEA and OrbiMed, Imara’s sole candidate is an oral, once-a-day therapy entering Phase 2b trials in the coming months. A creation of New Enterprise Associates’ orphan drug accelerator Cydan, the biotech is a solo med purveyor right now, with a mid-stage therapy for sickle cell disease. The biotech licensed small molecule PDE9 inhibitors from Lundbeck with an eye to their ability to influence red blood cell abnormalities. Imara lists on the Nasdaq under the symbol “IMRA.” Morgan Stanley, Citi and SVB Leerink acted as lead managers on the deal. Shares closed the week unchanged at $16.
  • Elsewhere, DFP Healthcare Acquisitions Corp., the second healthcare-focused blank check company formed by Deerfield Management and Robert Barasch, raised $200 million by offering 20 million units at $10. Each unit consists of one share of common stock and one-quarter of one warrant exercisable at $11.50. Deerfield Management intended to purchase $50 million worth of units in the offering. The special purpose acquisition company (SPAC) is led by CEO Steven Hochberg, a Partner at Deerfield, and Executive Chairman Richard Barasch, who serves as Chairman of AdaptHealth, which merged with Deerfield’s SPAC DFB Healthcare Acquisitions in 2019. NYC-based DFP Healthcare Acquisitions lists on the Nasdaq under the symbol “DFPHU.” Deutsche Bank, Jefferies and UBS Investment Bank acted as lead managers on the deal. Shares closed the week unchanged at $10.
  • Included among recent SEC filings for initial public offerings, Lyra Therapeutics Inc. registered $57.5 million worth of common. The Watertown, MA-based firm develops integrated drug and delivery solutions for the localized treatment of ear, nose and throat disorders leveraging its technology platform called XTreo, designed to deliver medicines directly to affected tissue for sustained periods via a single administration. Lead candidate is Phase 2-stage LYR-210, a bioresorbable polymeric matrix administered non-invasively in a doctor’s office, that delivers medication (mometasone furoate) for as long as six months to the sinonasal passages for the treatment of chronic rhinosinusitis (sinus inflammation). Mometasone furoate, a corticosteroid, is the active ingredient in certain nasal sprays for sneezing and runny noses and topical treatments for dermatitis and psoriasis. The company hopes to trade on the NASDAQ under the symbol “LYRA.”
  • Zentalis Pharmaceuticals Inc. registered up to $100 million in an IPO. The New York City-based biopharmaceutical firm develops small molecule cancer therapies based on its Integrated Discovery Engine. Lead candidate is ZN-c5, an oral selective estrogen receptor degrader (SERD) in Phase 1/2 development for ER+/HER2- advanced/metastatic breast cancer. Topline data from the first phase should be available in H2. Other pipeline candidates include Phase 1/2-stage ZN-c3 for solid tumors and Phase 1/2-stage ZN-e4 for non-small cell lung cancer (NSCLC). The company hopes to trade on the NASDAQ under the symbol “ZNTL.”
  • And Ayala Pharmaceuticals Inc.(AYLA) registered up to $50 million worth of common in an IPO. The Rehovet, Israel-based biopharmaceutical outfit develops treatments for rare and aggressive cancers by leveraging its bioinformatics platform and next-gen sequencing. Lead candidate is AL101, a selective injectable small molecule gamma secretase inhibitor (GSI) in-licensed from Bristol-Myers Squibb in November 2017, in Phase 2 development for certain adenoid cystic carcinoma patients. Candidate #2 is AL102, an oral GSI also in-licensed from Bristol Myers, for the potential treatment of desmoid tumors. The company hopes to trade on the NASDAQ under the symbol “AYLA.”

The cumulative effect of high blood pressure from young adulthood to middle age is associated with poorer mental function at age 50, a new study concludes.

For their analysis, published in Circulation, researchers looked at 191 generally healthy men and women ages 18 to 30 who were participating in a larger health study. Over the next 30 years, they measured their blood pressure with nine periodic readings to create a cumulative blood pressure score.

They measured mental acuity with tests of memory, attention, judgment, planning and decision-making. They also tested gait speed and length, since slow gait and short steps may be markers of poor blood vessel function. The study controlled for race, sex, smoking, diabetes, total cholesterol and other factors. The average blood pressure at the start was 108/66, well within the healthy range. But blood pressure increases with age, and they found that higher cumulative blood pressure, even at averages below the normal threshold of 140/90, was associated with slower gait, shorter steps and poorer cognitive performance.

The lead author, Dr. Simin Mahinrad, a postdoctoral researcher at Northwestern, said it is important to know not only how high blood pressure is, but also for how long it has been high. “Identifying people at risk at earlier stages is important,” she said. “Old age may be too late.” (Ref: The New York Times)

More than half of Americans want money and control when companies or organizations use their genetic data, a new study suggests.

Public views about the value of DNA continue to evolve, especially as people become more concerned about privacy, the study authors write in PLoS ONE.

“The public’s views need to be included in decision making about these databases,” said lead study author Forrest Briscoe of Pennsylvania State University in University Park. “People are learning that these data have value and that they are being used commercially and monetized,” he told Reuters Health. “People may want to think more about the ‘terms of the exchange’ and about the ‘deal’ they are striking when they provide their data.”

Briscoe and colleagues surveyed more than 2,000 people after presenting a video of mainstream media coverage of genomic database companies. They asked survey participants to imagine being invited to provide a saliva sample to an organization to be used in a biomedical research program. Then participants were asked: “Based on this information and what you have just learned about DNA data, how willing would you be to provide your DNA data?” The four options were “willing as a charitable donation,” “willing if I’m paid at least a certain amount of money,” “unwilling, at least for now” and “unwilling, now or ever.”

About 12% were willing to donate their data, 51% were willing to provide data if they were financially compensated, and 38% were unwilling to provide data. The average expected compensation was about $130, which mirrored the amount mentioned in the media coverage. Participants also preferred governance policies that restricted data sharing or reuse unless the individual gave permission. These preferences didn’t vary much, whether the hypothetical organization was a for-profit technology corporation, a for-profit drug company, a non-profit hospital system, a university lab or the National Institutes of Health, the researchers found.

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