Exelixis Guidance Drags On Quarterly Beat

 Cancer-focused biotech Exelixis (EXEL) maintained its outlook despite nabbing a quarterly beat, and EXEL stock fell, undercutting its 50-day line Wednesday.

Still, at least one analyst says the upcoming year will provide numerous catalysts for Exelixis. Before the end of the year, Exelixis is expected to unveil the results of two studies of its blockbuster medicine, Cabometyx, in combination with Roche's (RHHBY) Tecentriq. The companies are testing the combo in patients with lung and kidney cancers.

Further, Exelixis is working on a next-generation version of Cabometyx as well as other earlier-stage drugs, RBC Capital Markets analyst Gregory Renza said in a report.

"We see the second half of 2022 setting up as a year of clinical execution/maturation for Exelixis' earlier-stage pipeline," he said.

But on today's stock market, EXEL stock toppled 7.4% to 19.50. Shares tumbled below their 50-day moving average, according to MarketSmith.com.

During the second quarter, adjusted Exelixis earnings tumbled 26% to 28 cents per share. But that easily beat expectations for a 19-cent gain. Revenue grew almost 9% to $419.4 million, topping the average estimate of EXEL stock analysts polled by FactSet for $391 million in sales.

The sales break down into $347 million from Exelixis' drugs, just north of $57.5 million for license revenue, and close to $14.9 million from collaboration services revenue.

The majority of Exelixis' sales stem from its drug, Cabometyx. Cabometyx treats thyroid, kidney and liver cancers. During the quarter, Cabometyx sales surged 22%, ballooning up to $339.2 million vs. expectations for $343 million to $345 million in total product sales, RBC's Renza said.

The strong growth signals there's still room for Cabometyx use to grow among previously untreated patients with renal cell carcinoma, a form of kidney cancer, he said. But the drug also faces increases in discounts, allowances, higher Medicare use, gross-to-net and copay assistance programs, he said.

https://www.investors.com/news/technology/exel-stock-exelixis-earnings-q2-2022/

'Targeting impulsivity early in adolescence could prevent later behavioral disorders'

 Tendencies toward impulsivity in early adolescence are linked with a variety of poor outcomes in later adolescence, including antisocial personality disorder and alcohol use disorder. However, by the time teenagers reach mid-adolescence, it may be too late to target impulsivity to prevent the development of these behavioral disorders.

Past research has shown the link between impulsivity and these disorders, but not how it unfolds. Now, a new study based on data tracking hundreds of Philadelphia youth over more than a half-dozen years details the complex pathway connecting impulsivity, alcohol use, and antisocial behavior.

The findings suggest that targeting adolescents who exhibit high levels of impulsivity in early adolescence could halt a cascading chain of events that leads to late-adolescence antisocial personality disorder (APD) and alcohol use disorder (AUD).

"Kids with impulse control problems are at risk for a variety of adverse outcomes, such as drug use, acting-out behavior, and antisocial behavior," said study co-author Dan Romer, research director of the Annenberg Public Policy Center of the University of Pennsylvania. "What we've found is that you've got to start mitigating impulsivity before it starts influencing behaviors that lead to substance use and antisocial behavior disorders. Once adolescents are on a trajectory of engaging in those behaviors, it may become more difficult to prevent disorders later in adolescence than it is to treat impulsivity itself."

The open-access study, published this week in the Journal of Adolescent Health, was conducted by researchers from the Annenberg Public Policy Center (APPC), University of Amsterdam, University of Oregon, and Children's Hospital of Philadelphia.

The Philadelphia Trajectory Study

The study is based on data from the Philadelphia Trajectory Study, a six-wave study during which participants ages 10 to 12 were interviewed annually from 2004 to 2010, with a final two-year follow-up in 2012. The current study relies on five years of self-reported data, from waves 3 through 6. During the final wave the participants were 18 to 21 years old. The study was based on data from 364 adolescents (at wave 3) of diverse ethnic backgrounds.

The researchers said that to the best of their knowledge, "this is the first study to investigate cascading mediating links between impulsivity, alcohol use, and antisocial behavior across adolescence."

Adolescent impulsivity and antisocial behavior

The researchers found that from early to mid-adolescence, changes in impulsivity predicted changes in antisocial behavior and alcohol use. But by the time the participants had reached mid- to late adolescence, changes in impulsivity no longer predicted those behaviors. Instead, it was engaging in antisocial behavior that predicted subsequent symptoms of both alcohol use and antisocial personality disorders.

"It is also important to target antisocial behavior to interrupt the cascade that predicts both alcohol use disorder and antisocial personality disorder," said the lead author, Ivy Defoe, an assistant professor at the University of Amsterdam and a former postdoctoral fellow at the Annenberg Public Policy Center. "In fact, the study showed that increases in antisocial behavior in mid- to late adolescence further predicted increases in impulsivity as well. This is consistent with labeling theory that suggests that individuals who show antisocial behavior are subsequently labeled as 'antisocial' or 'rule-breakers,' which causes them to further exhibit attributes that are associated with such behavior."

In view of the mental health crisis among adolescents, it is critical to identify youths with conditions that can lead to later disorders. Screening for such conditions is one way to alert parents about the risks and to refer youths for treatment. As the researchers said, "Intervening early is critical to further avoid the consequences of impulsivity which are more difficult to reverse once psychopathology has developed." Such interventions, the researchers said, could include mindfulness training and family-based interventions in which parents and caregivers work to help their child overcome harmful impulsive tendencies.

Most of the participants were from families with a low-middle socioeconomic status (SES). The researchers found that socioeconomic status was a significant predictor of impulsivity at each wave of the study. "Future research could further investigate the mechanisms by which early exposure to socioeconomic disadvantage influences heightened impulsivity during adolescence, including impacts on child executive functioning and parenting behaviors," the researchers said.

In addition to Defoe and Romer, the study was authored by Atika Khurana of the University of Oregon and Laura M. Betancourt and Hallam Hurt of Children's Hospital of Philadelphia.

Story Source:

Materials provided by Annenberg Public Policy Center of the University of Pennsylvania. Note: Content may be edited for style and length.

---

Journal Reference:

1. Ivy N. Defoe, Atika Khurana, Laura M. Betancourt, Hallam Hurt, Daniel Romer. Cascades From Early Adolescent Impulsivity to Late Adolescent Antisocial Personality Disorder and Alcohol Use Disorder. Journal of Adolescent Health, 2022; DOI: 10.1016/j.jadohealth.2022.06.007

https://www.sciencedaily.com/releases/2022/08/220809194924.htm

For Many Infections, Source Control Is Key

 If you're in a specialty that asks for infectious disease (ID) consultations, you've probably been on the receiving end of a recommendation for source control. Indeed, some infections show little to no benefit from antibiotics without an accompanying intervention, whereas others require no antibiotics at all once surgical source control has been accomplished.

Source control is the key to successful management of many infections because it: (a) offers direct evacuation or reduction of infectious foci; (b) reduces bacterial load; (c) allows debridement of devitalized tissue, which helps restore proper physiologic function; (d) removes infected devices or foreign materials; and (e) enhances antibiotic delivery to a site of infection.

Patients who undergo efficient and effective source control exhibit faster resolution of sepsis symptoms and demonstrate improved patient outcomes; in addition, they often can be treated with shorter antibiotic courses (or no antibiotics at all), which may lessen the influence on antimicrobial resistance.

Yet, I often find the "push and pull" conversations about source control, usually prompted by a requested ID consultation, to be one of the most stressful parts of my workday. Rest assured, I don't recommend source control lightly — I'd love to help a patient avoid an invasive procedure, device removal, or surgical intervention too. It is just the unfortunate truth that some infections cannot be cured without these measures (and in some cases, a delay in such measures is truly life-threatening).

As specialists in IDs, we've been trained to recognize infections that necessitate source control. We've studied the limitation of antibiotics when used alone vs when used in combination with source control. We've read the studies that confirm improved outcomes with prompt debridement, drainage, or device removal. And we've witnessed the patients who have suffered from ongoing pain, persistent sepsis, irreversible tissue destruction, or even death when source control has been deferred or could not be performed.

Over the years, the discussions with other providers about source control have become both more frequent and more tense. While this may be a personal perception, I've overheard colleagues in infectious diseases and other specialties express similar sentiments. I'm sure there are many varied (and provider-dependent) reasons for this shift. But admittedly, it can sometimes be difficult for those of us in nonsurgical specialties to understand an increased reluctance to proceed with source control.

Sometimes, all of the providers on a patient's multidisciplinary team feel that source control of an infection would be ideal, but the necessary intervention is unfortunately unable to be performed. More often, though, the various specialties reach an impasse. For example, the primary team and/or ID service might feel strongly that source control is needed for clinical improvement and an attempt at a cure, but the surgical service does not agree that an intervention is warranted or possible. At this point, the conversations between team members and between providers and patients can be tricky to navigate.

Sometimes, I've been told to "stay in your lane" when I've suggested that an intervention is highly recommended for a certain infection. Other times, I've been told that a patient is not a surgical candidate for source control, even though they've been cleared for surgery by their primary service. I've had a general surgeon tell me that he wouldn't take an otherwise healthy but actively bacteremic/septic patient with a loculated gluteal abscess for debridement because he "didn't want to risk introducing a new infection."

Medical students and residents on the ID service are sometimes part of these source control conversations, and they've expressed concern about engaging in such difficult discussions in the future. How do we best convey our clinical and surgical opinions to each other so that appropriate and timely treatment decisions can be made? And how can providers ensure that their patients aren't caught in the middle when those opinions differ? Unfortunately, I don't have the perfect answers to these questions.

My strategy is to make sure the ID team reviews the entire patient chart so that we've heard all sides of the conversation about the management of infection. I share why I feel strongly about source control with the students and residents, and we make those concerns known directly to the patient's other providers. We talk about the expected efficacy of antibiotics when used alone compared with their use in conjunction with source control. And I expect students and residents to be able to weigh the theoretical risks for intervention against the real-time risks for a potentially life-threatening infection.

Hopefully, my colleagues in other specialties (both surgical and non-surgical) are doing the same: fully reviewing the patient's chart, having respectful discourse with other team members about infectious management, addressing the limitations of antibiotics, and assessing theoretical vs actual risks when considering interventions for source control. It's what our patients deserve and it's what we, as antimicrobial stewards, should willingly do.

Roni K. Devlin, MD, MBS, is an infectious diseases physician currently residing in the Midwest. She is the author of several scholarly papers and two books on influenza. With a longstanding interest in reading and writing beyond the world of medicine, she has also owned an independent bookstore, founded a literary nonprofit, and published articles and book reviews for various online and print publications. 

https://www.medscape.com/viewarticle/978848

Singular Genomics cut from Buy by 2 sell siders

Aug-10-22 Downgrade Goldman Buy → Neutral $3.50

Aug-10-22 Downgrade BofA Securities Buy → Underperform $3

https://finviz.com/quote.ashx?t=OMIC

BioAtla results and update

 

• Mecbotamab vedotin (BA3011) Phase 2 preliminary observations in Non-Small Cell Lung Carcinoma (NSCLC) supports advancing to the registrational stage of the study; anticipate full interim data set in 4Q22
  
  

• Mecbotamab vedotin (BA3011) Undifferentiated Pleomorphic Sarcoma (UPS) and osteosarcoma Phase 2 part 2 enrollment anticipated to begin 4Q22 following requested written feedback from FDA; continuing to enroll additional cohorts
  
  

• Mecbotamab vedotin (BA3011) sarcoma Phase 2 top-line interim data support advancing with liposarcoma and synovial sarcoma; next steps under evaluation
  
  

• Ozuriftamab vedotin (BA3021) NSCLC and Squamous Cell Carcinoma of the Head and Neck (SCCHN) Phase 2 studies ongoing as planned; NSCLC preliminary cohort interim update on track for 2H22, SCCHN trial ongoing with first patient dosed now anticipated in 3Q22; melanoma enrollment ongoing with status update using new validated Circulating Tumor Cell (CTC) assay anticipated Q422
  
  

• CAB-CTLA-4 (BA3071) Phase 1 study ongoing with first patient dosed
  
  

• Cash balance of $202.3 million at quarter-end expected to provide funding into 2H24
  
  

• Management to host conference call and webcast today at 4:30 PM Eastern Time

The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, August 9, 2022, at 4:30 pm Eastern Time. A live webcast may be accessed here: https://edge.media-server.com/mmc/p/czrtgcet. The conference call can be accessed by dialing toll-free (844) 826-3035. The passcode for the conference call is 10169204.

A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.

https://finance.yahoo.com/news/bioatla-reports-second-quarter-2022-200500786.html

Why Invitae Stock Is Skyrocketing

 Shares of Invitae (NVTA 63.05%) were skyrocketing 53.5% as of 11:14 a.m. ET on Wednesday. The huge gain came after the medical genetics company announced its second-quarter results following the market close on Tuesday.

Second-quarter revenue was $136.6 million, up 17.5% year over year. The company posted a net loss of $2.5 billion, or $10.87 per share, based on generally accepted accounting principles (GAAP). Invitae's non-GAAP net loss in the second quarter was $158.5 million, or $0.68 per share. This was an improvement from the prior-year period and was better than the consensus estimate of a non-GAAP net loss of $0.74 per share.

The company also maintained its full-year revenue guidance of low double-digit growth. Invitae stated that it expects revenue growth to return to a range of 15% to 25% beyond 2023.

NYSE: NVTA

Invitae

Today's Change

(63.05%) $1.44

Current Price

$3.73

 NVTA

KEY DATA POINTS

Market Cap

$525M

Day's Range

$2.40 - $3.85

52wk Range

$1.83 - $32.93

Volume

56,065,974

Avg Vol

10,541,414

P/E (ttm)

As of July 15, more than 25% of Invitae's float was sold short. Today's second-quarter update was more bullish than anticipated. The resulting surge in Invitae's share price appears to be a short squeeze as short-sellers scramble to cover their positions.

It certainly doesn't seem to be smart to bet against Invitae at this point. The business is showing clear signs of improvement. Invitae said that its total active healthcare-provider accounts in the second quarter increased 25% year over year. Its active pharma and commercial partnerships jumped 52%.

Invitae's story could get even better in the not-too-distant future. The National Comprehensive Cancer Network recently updated its guidelines to endorse universal genetic testing for all colorectal cancer patients. Invitae thinks that its target patient population in colorectal cancer will more than double in the U.S. as a result.

https://www.fool.com/investing/2022/08/10/why-invitae-stock-is-skyrocketing-today/

Workers Strike at Medicare, ACA Call Centers

 Federally contracted call center workers who provide customer service for Medicare and Affordable Care Act health plans went on strike on Monday over poor working conditions, including insufficient sick leave and limited bathroom breaks.

Employees of Maximus, the nation's largest federal call center contractor, held a two-hour picket and a day-long strike Monday at four locations: Bogalusa, Louisiana; Hattiesburg, Mississippi; Chester, Virginia; and London, Kentucky. Workers partnered with the AFL-CIO and the Communications Workers of America (CWA) to negotiate with Maximus.

They said increased paid sick time and more flexible bathroom break policies will better allow them to care for themselves and their families as they facilitate access to healthcare for other Americans.

"I love my job. I love helping the consumers and making sure I assist them with their issues because it may be a small issue to us, but to them it could be a life-changing issue," Dae Mark, 22, who works at the Maximus call center in Hattiesburg, told MedPage Today. "And I don't want to let our consumers suffer due to how our supervisors and managers treat us."

Mark described a system where bathroom breaks are limited to 6 minutes, with pay deducted for every minutes she and her coworkers are off the clock past that time.

"With us working onsite and how big the building is on the inside, as well as the people-traffic within the workplace, it takes us about 2 to 3 minutes to even get to the bathroom," she said. Employees must log their bathroom break with a code at their desk and then mark it again when they come back. If they exceed the 6 minutes, they get a text message reminding them to deduct it from their time card, Mark said.

During a virtual town hall Monday afternoon, Mark said she has disabilities, as do many of her coworkers, and that she was terminated previously from Maximus for breaking what she described as an unnecessarily complicated attendance policy. She said she nearly became homeless before she was rehired last October.

Mark also said the company initially only approved a day of sick leave for COVID-19, but has increased that to 24 hours, or the equivalent of 3 days, since staff started organizing.

Still, she said, the CDC -- which contracts with Maximus along with CMS -- calls for 5 days of isolation with COVID-19. In order to meet that, Mark said, employees would have to use their limited accrued leave or take leave without pay.

Another Maximus worker, Brenna Rowell, said that as a single mother of a 3-year-old and a 6-year-old, finding childcare can be a challenge, but if she misses more work she could be fired.

"I like helping the people that we serve and I try to never miss work because I need every dollar I can [get] to support my children," she said at the town hall. "If I'm missing a day of work, it's because I have no other choice. It's either because I'm sick or I don't have a babysitter. What else am I supposed to do in that situation?"

Workers at the call centers are mostly women and people of color. A statement from the AFL-CIO noted that the Hattiesburg site, for example, is around 81% female and 91% people of color. Workers make around $35,000 a year, compared with the $61,120 a year that MIT's "Living Wage Calculator" for that area considers to be a living wage before taxes for an adult with one child.

A flyer that Maximus workers handed out to prospective hires at a Maximus job event in July said workers were paid almost 40% less than other federal call center workers, like those at the IRS. The healthcare plans offered by Maximus had deductibles of $5,000 for family coverage, and increasing out-of-pocket costs, according to the flyer.

Eileen Rivera, vice president of public relations and communications at Maximus, said in an email to MedPage Today that employees can take two 15-minute breaks and a half-hour lunch break during 8-hour days, and request bathroom breaks any time.

"No one is denied a break; no one is shamed for taking a break," she wrote. Rivera also sent a job posting for a customer service representative position at $16.38 an hour.

But Maximus worker Jessyka Davis said at the town hall that unexpectedly long calls can eat up those break times, which are scheduled ahead of time, and that workers can be penalized for taking a break outside of those times without approval.

Also speaking at the town hall, Sara Steffens, a CWA secretary-treasurer, said: "Throughout the pandemic, you all provided essential life-saving services, but Maximus has failed to treat you with the respect you deserve. The company's restrictive and demeaning attendance and bathroom break policies are totally unacceptable. And by going on strike, you were sending a clear message you were fed up -- that your health and dignity are not up for debate."

Rowell said of Maximus leadership: "Let them take a day in our shoes and see for themselves exactly how it is. It's not just butterflies and rainbows, as they're stating to us."

https://www.medpagetoday.com/special-reports/features/100135