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Thursday, July 22, 2021

ImmunoPrecise Antibody Cocktail Potently Neutralizes SARS-CoV-2 Delta Variant in Vitro

 IPA publishes its scientific paper "Cornering an Ever-Evolving Coronavirus: TATX-03, a Fully Human, Synergistic, Multi-Antibody Cocktail Targeting the SARS-CoV-2 Spike Protein with in vivo Efficacy" on bioRxiv

IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) today announced new results from its TATX-03 PolyTope™ Therapy, a four monoclonal antibody cocktail developed for the potential prevention and treatment of SARS-CoV-2, demonstrating potent pseudovirus neutralizing activity against the SARS-CoV-2 Delta (B.1.617.2) variant.

The Company anticipated viral evolution leading to novel SARS-CoV-2 variants of concern throughout the design of their PolyTope SARS-CoV-2 therapeutic cocktail, aiming to minimize the risk of mutagenic escape (a reduction or elimination in the efficacy of a therapy or vaccine by virus mutation). As such, the Company continuously validates, and has demonstrated to date, maintained neutralization potency of IPA’s multi-antibody cocktail towards SARS-CoV-2 variants of concern. IPA previously announced that TATX-03 demonstrated strong efficacy in reducing viral load in vivo using a hamster challenge model and potently neutralized pseudovirus of Alpha (B.1.1.7) and Beta (B.1.351) variants in vitro.

Additional evaluation of virus neutralization potency in an in vitro pseudovirus-based assay revealed that IPA’s TATX-03 anti-SARS-CoV-2 antibody cocktail is also not affected by the rapidly spreading Delta variant (B.1.617.2). Parallel reactivity screening of the individual antibodies of TATX-03 revealed differential susceptibility of the lead components towards the Delta (B.1.617.1) variant with the majority showing maintained binding. These results are consistent with previously announced binding data towards other SARS-CoV-2 mutants, including variants of concern Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) variants. These binding data, combined with the maintained neutralization potency of IPA’s TATX-03 to variants of concern, supports the Company’s expectation that rationally designed multi-membered antibody cocktails are more sustainable, e.g. will be functionally less prone to escape-by-one mutations.

NeuroMetrix Reports Q2 2021 Financial Results

 NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter ended June 30, 2021. The Company is a leader in proprietary non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders.

Highlights:

  • Revenue of $2.2 million improved 63% from $1.4 million in Q2 2020. The Q2 2020 results were adversely affected by a pandemic-related decline in customer orders. Gross margin on revenue was $1.7 million or 74.8%, an increase of 11.2 percentage points from the 63.6% gross margin rate in Q2 2020.

  • Net loss for the quarter was $0.5 million in comparison to a net loss of $0.8 million in Q2 2020.

  • The domestic Medicare Advantage business was the primary contributor to DPNCheck® revenue during the quarter.

  • The Quell® direct to consumer business delivered positive operating margins.

  • The Company continued development of its investigational device, based on Quell technology, for treating fibromyalgia symptoms and anticipates a regulatory filing later this year. Related to this program, results from a randomized, sham-controlled trial of Quell for treatment of fibromyalgia were presented at two pain medicine conferences.

  • The Company utilized its at-the-market (ATM) facility to raise $3.8 million in net proceeds from the sale of common stock.

  • Subsequent to the end of the quarter the Company reported that Quell had received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for treating the symptoms of fibromyalgia in adults.

"We continued to make progress in both the DPNCheck and Quell business lines. We believe we are laying the groundwork for steady top-line growth going forward,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “It was particularly rewarding to share the Quell fibromyalgia data with international pain medicine experts in June and to receive Breakthrough Device Designation from the FDA. We look forward to advancing this program towards a commercial launch in 2022.”

Company to Host Live Conference Call and Webcast

NeuroMetrix will host a conference call at 8:00 a.m. Eastern today, July 22, 2021. The call may be accessed in the United States at 844-787-0799, international at 661-378-9630 using confirmation code 4269315. A replay will be available starting two hours after the call at 855-859-2056 United States and 404-537-3406 international using confirmation code 4269315. It will remain available for one week. The call will also be webcast and accessible at www.NeuroMetrix.com under "Investor Relations".

https://finance.yahoo.com/news/neurometrix-reports-q2-2021-financial-110000339.html

Tenet Earnings Beat But THC Stock Falls

 Tenet Healthcare (THC) reported better-than-expected second-quarter earnings late Wednesday, but gave weak guidance. THC stock fell sharply in overnight trade after closing in a buy zone.

Hospital stocks have been in good health, fueled by blowout HCA Healthcare earnings early Tuesday.

Tenet Earnings

Estimates: Analysts expected Tenet earnings per share to fall 13% to $1.09 a share, according to Zacks Investment Research. Revenue was seen growing 31% to $4.77 billion, the third straight quarter of accelerating growth. Year-ago Tenet earnings included $523 million in federal stimulus grants to help hospitals overcome losses and expenses related to the pandemic.

Results: Tenet earnings rose 26% to $1.59 a share. Revenue climbed 36% to $4.95 billion.

Outlook: The hospital operator see Q3 adjusted EPS of 73 cents to $1.06 on revenue of $4.6 billion to $4.8 billion. That's below Wall Street estimates for Tenet earnings of $1.10 and $4.837 billion in revenue.

Tenet sees full-year EPS of $5.23-$5.73 vs. $4.16-$5.46 previously. The new $5.48 midpoint is above the consensus for $5.21, but that includes Q2's 50-cent beat. Its new 2021 revenue midpoint of $19.45 billion is below consensus at $19.54 billion, even with Q2's beat.

https://www.investors.com/news/thc-stock-tenet-earnings-on-tap-hospital-stocks-flash-buy-signals/

English COVID contact tracers tell around 428,000 to isolate

 Around 428,000 people were contacted by COVID contact tracers in England and told to self-isolate in the week to July 14, the health ministry said on Thursday.

The government said that around 90% of the 475,465 people identified as close contacts of COVID cases in the latest week had been reached and told to self-isolate by NHS Test and Trace.

https://news.yahoo.com/english-covid-contact-tracers-tell-102448490.html

Embedded as a Risk, New COVID Cycle Could Challenge Fed, Recovery

 Five weeks after dropping its reference to the coronavirus as a weight on the economy, the U.S. Federal Reserve is confronting a challenging new rise in cases that has fueled doubts about the global recovery and is already forcing other central banks to consider retooling their policies.

The daily pace of new infections has more than doubled since the Fed's June 16 policy meeting, when Chair Jerome Powell said that while it was "premature to declare victory" given the appearance of the more infectious coronavirus Delta variant, a decline in infections, hospitalizations and deaths "should continue."

It hasn't, and while the worst current outbreaks have been localized, news of rising case loads once again straining hospital capacity spilled into financial markets with a sharp Monday sell-off.

U.S. Treasury yields have tumbled in a sign investors may be losing confidence in both the U.S. growth outlook and the Fed's ability to navigate between the shoals of a resurgent pandemic that may require more help from the central bank and high inflation that may demand a more restrictive approach.

Analysts still expect economic growth in 2021 to be the strongest since 1984, but are now again mining real-time data for signs the Delta variant is changing behavior.

"Do vaccinated people stay off airplanes? That is the downside risk," said Wells Fargo Corporate and Investment Bank Chief Economist Jay Bryson, who is so far maintaining a forecast of 7% economic growth this year. "I don't think any of us are expecting lockdowns like we saw a year ago. The population is not going to stand for that. But you don't have to have lockdowns. You just have to have people saying, 'I am staying home.'"

No obvious evidence has emerged yet of that happening. Air travel has remained steady at around 80% of its pre-pandemic level, according to Transportation Security Administration statistics, and there's been no dip in diners returning to restaurants, according to data from restaurant site OpenTable.

Attendance at Major League Baseball games over the seven days through Monday had climbed back to the 2019 average for the first time this year, with stadiums now open to capacity crowds

Yet the Fed's scheduled meeting next week will be newly complicated, overshadowed by something epidemiologists have warned even as vaccinations rolled out: Coronavirus will not fade easily, and is likely to remain a cyclical risk to people's health and the economy for years to come.

The Fed in June signaled it had begun planning a shift to post-pandemic monetary policy, with the risk of rising inflation seen as paramount and some policymakers ready to reduce the Fed's $120 billion in monthly bond purchases and accelerate eventual interest rate hikes.

The Reserve Bank of Australia may offer a note of caution. The bank began its own bond "taper," only to see the country impose new lockdowns that economist feel will force the RBA to reverse course.

Meanwhile, the Delta variant "could tap the brakes" on the U.S. recovery, Minneapolis Federal Reserve President Neel Kashkari told National Public Radio over the weekend, "which would be a really big setback for us."

'HEIGHTENED SENSE OF RISK'

The health policy response to the Delta variant spread has been modest. Los Angeles reinstated an indoor mask mandate. On Monday the American Academy of Pediatrics said schools should open in-person in the fall, but recommended universal masking for staff and children over 2 years old.

Infections and fatalities remain well below last winter's trauma. New daily cases of around 37,000 are a fraction of the quarter of a million per day in January.

Daily deaths of around 200 are "tragic...but not out of proportion to other major health problems" such as auto accidents, said Dr. David Dowdy, associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.

With about 60% of U.S. adults fully vaccinated and a portion of the rest likely resistant from previous infection, "We should not be panicking," he said.

Graphic: Infections rise again: https://graphics.reuters.com/USA-ECONOMY/CORONAVIRUS/akpezggydvr/chart.png

Yet with many adults still susceptible, a national vaccine drive stalled, and children under 12 not yet approved for immunization, the last few weeks suggest the handoff to post-pandemic policy may remain bumpy.

Among the core assumptions behind current Fed thinking, for example, is that a full reopening of in-person schooling this fall will free parents to resume work - a process that could now falter and slow the hoped-for recovery of nearly 6.8 million missing jobs.

"There will certainly be parents who will push back against in-person attendance. Those same parents may be hesitant to return to offices," wrote Northern Trust Chief Economist Carl Tannenbaum. "Even if formal restrictions are not reintroduced, a heightened sense of risk among populations will create complications for commerce."

 Centers for Disease Control collection of major epidemiological models shows forecasts between now and early August of anywhere from a few thousand cases per day to a massive outbreak rivaling last winter.

Wells Fargo's Bryson said he is watching the United Kingdom, with vaccination rates similar to the United States and a large surge in recent infections, for signs of what may be coming.

There remains a large pool of household savings to keep the bills paid, socked away during the pandemic from an array of federal programs. Businesses meanwhile have adapted to operate more safely around the virus, with touchless QR code menus now omnipresent at restaurants, and web-based ordering systems further reducing staff interactions with customers.

But the ebb and flow of the disease will still need to be managed, and by the fall most of the pandemic support programs set up to help in that process will have ended, including additional federal unemployment insurance payments and a moratorium on rental evictions.

"This is not going away. It is going to be endemic," with possible implications for policy if, for example, the restaurant or other industries end up with cyclical coronavirus slowdowns and a new seasonal pattern to employment, said Tim Duy, chief U.S. economist with SGH Macro Advisors. "The public health goal now is to make it a non-event."

https://money.usnews.com/investing/news/articles/2021-07-22/embedded-as-a-risk-new-covid-cycle-could-challenge-fed-recovery

Celldex started at Buy by Guggenheim

 Target $66

https://finviz.com/quote.ashx?t=CLDX&ty=c&ta=1&p=d

Landos Biopharma’ Presents on Phase 2 Data of Omilancor in Ulcerative Colitis

 Omilancor shows efficacy and tolerability as a potential once-daily, oral, gut-restricted therapy for mild-to-moderate UC patients

Following the recent positive End-of-Phase 2 meeting with the FDA, Landos initiated clinical trial site feasibility studies for the planned global pivotal Phase 3 trial of omilancor in UC

https://finance.yahoo.com/news/landos-biopharma-phase-2-data-110000903.html