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Tuesday, December 3, 2019

Rapt Therapeutics teams up with Hanmi on FLX475 in Asia; shares up after hours

Rapt Therapeutics (NASDAQ:RAPT) will collaborate with South Korea’s Hanmi Pharmaceutical Co., Ltd. to develop and commercialize cancer candidate FLX475, a CCR4 antagonist, in Asia.
Under the terms of the agreement, RAPT will receive $10M upfront, up the $48M in development milestones, up to $60M in sales milestones and double-digit royalties on net sales. Hanmi will have an exclusive license to FLX475 in South Korea and China (including Taiwan and Hong Kong).
Shares up 12% after hours.

Dexcom: Outage that kept diabetics from tracking blood sugar ‘complete surprise’

  • Dexcom experienced it’s largest ever technical glitch over the weekend.
  • The company’s technology chief acknowledged that Dexcom needs to do better.
  • Dexcom is analyzing its tech infrastructure and working to bolster its communications systems.
CNBC: Kevin Sayer, Dexcom 191113 2
Kevin Sayer, CEO, Dexcom
Scott Mlyn | CNBC
Dexcom’s technology chief admits that the maker of continuous blood sugar monitoring systems was caught flat-footed by a technology outage over the Thanksgiving holiday weekend, and was ill-equipped to properly inform users of the problem.
Because of a server glitch, a large number of Dexcom’s customers, who rely on the company’s technology to manage their diabetes treatment, weren’t alerted to potentially dangerous changes in their blood glucose levels. The issue was of particular concern to parents who use Dexcom’s system to monitor their kids’ health.
“It was a complete surprise,” said Jake Leach, Dexcom’s chief technology officer, in an interview late Monday, after CNBC published a story on the ongoing problem. Leach said the company didn’t have any scheduled updates over the weekend. “This is a real learning opportunity to look at our system architecture.”
Dexcom acknowledged that the bug affected a “large portion” of its users in the U.S. who rely on its Follow feature, which lets users share their glucose readings with caregivers or family members. It began very early Saturday morning, with some parents saying they figured out something was wrong after their kids went to bed Friday night.
The company says it has a system for monitoring technology problems 24 hours a day and recognized what was happening right away though it didn’t know that the outage was so widespread and that it was expanding. Leach said that over the weekend, Dexcom pulled in its internal engineers to work on restoring the system and recruited help from its technology infrastructure partners.
Dexcom relies on Google’s cloud service and also uses some Microsoft technology. Almost immediately, Leach’s team started reaching out to Google to see if it could troubleshoot the problem. Microsoft also offered to help fix what had rapidly become Dexcom’s largest ever glitch.
Dexcom down
Dexcom is still experiencing intermittent technical issues.
Erin Black, CNBC
The company even evaluated potential influence from foreign hackers, but didn’t find evidence of a data breach.
As of Monday, the outage was mostly resolved but some intermittent issues persisted. Leach said Dexcom has been reassessing its entire back-end system to make sure this doesn’t happen again.
One major fix the company is working on is improving its ability to message customers in real time. Currently, the messaging feature isn’t set up to inform users that the alert system isn’t working, Leach said, so Dexcom has been limited to updating people through its Facebook page.
Users who were unaware of Dexcom’s Facebook updates were stuck. Some started deleting and reinstalling the smartphone app, only to find that they could no longer log in, because that feature was also affected.
As Melinda Wedding, a mother of a teenager with diabetes told CNBC, “I get more information, more quickly when there’s an outage on my Dropbox than I do for my child’s blood sugar monitor.”
Leach said the company is “always evaluating” upgrades to its customer service, especially in light of criticisms from users who say they didn’t receive a call back or email response quickly enough.
“Ultimately we need to be able to communicate faster, and in a broader way,” he said. “Clearly, there’s an opportunity there.“

Medicare Advantage’s Dirty Little Secret: Getting out is a lot harder than getting in

Like many of the 22 million seniors now enrolled in Medicare Advantage (MA) plans, Tom Mills belatedly discovered its dirty little secret.
Also called Part C, these plans can cover a broad array of health services at low cost — that is, until one gets sick, at which point out-of-pocket costs can soar. But once in an MA plan, getting out can be even less affordable.
After Mills underwent a mitral valve repair and suffered a mild stroke with no lasting effects, the San Diego resident’s plan now charges him hundreds of dollars in monthly copays for drugs and other medical services. He had to pay $295 a night for his hospital stay.
But there was a much bigger shock. Mills, 71, learned that switching out of his MA plan will incur exorbitantly higher costs the next time he needs a serious medical intervention. If he moves to traditional Medicare and a prescription plan, he still needs a supplemental Medigap plan to pick up his 20% copays and deductibles.
Though the retired environmental geologist is training for his 57th half marathon, he now has a pre-existing condition. Medigap plans in all but four states can and do reject people like him or require prohibitively higher premiums. Diabetes, heart disease, or even a knee replacement can be criteria for exclusion.
A health insurance broker told him no supplemental plan would cover him, and he’d be wasting his time if he applied.
No one told him about this side of MA when he enrolled at age 65. “You hear the pros, but nobody lists the cons.”
In the run-up to the Dec. 7 deadline to sign up for Medicare coverage, broadcast ads like one with Joe Namath tout Medicare Advantage’s array of services: dental, vision, hearing, gym membership, rides to medical appointments, doctor and nurse visits by phone, and even meal delivery and home aid. “Get what you deserve … at no additional cost,” Namath says. “Call now — it’s free.”
But some advocacy groups, including the American Medical Association (AMA), are pushing to mandate tighter plan rules and disclosure, with lists of network specialists. The AMA recently approved a resolution calling on the Centers for Medicare & Medicaid Services and other stakeholders, including the senior citizens’ lobby AARP, to make the process of choosing Medicare plans less confusing and more transparent.
A similar AMA resolution in 2018 declared that “seniors are lured to these advantage plans by misinformation and confusing sales techniques,” and that plan inadequacies result in “delay in nursing home placement for some members,” produce “poor service for some members … due to difficulties with physical therapy and rehab services. The number of days approved (for payment) has tended to be too short and the extent of rehab services too limited.”
Kevin Burke, MD, and Deepak Azad, MD, primary care doctors in Indiana, are members of the delegation that sponsored both resolutions.
“If your health is good, maybe these plans represent value for some patients, like providing gym memberships,” Burke said. “But that can change in the blink of an eye … with a stroke or an accident or some acute medical condition and they need a rehabilitation stay.” Then, services are restricted so much that “they can’t recover adequately from the stroke, or they bankrupt themselves staying another month to get a good recovery.”
Then they’re eligible for Medicaid, which pays doctors much less.
Burke and Azad think Medicare should not let people with serious health risks buy MA plans in the first place. And some critics say MA across the board is basically a scam.
‘Confusing’ Tools
Medicare.gov websites aren’t always clear about the process of transferring out of MA to traditional Medicare with a Medigap plan, but the general bottom line is that getting accepted by a Medigap plan is guaranteed only within the first 12 months after enrolling in Medicare at age 65.
MA plans, which are managed by private insurers, can be very complex, with the potential for substantial out-of-pocket costs when beneficiaries get sick played down. Medigap policies, which pay for many expenses not covered in basic Medicare, may cost more in monthly premiums up front, but once one is enrolled, premiums are set solely through “community rating” and beneficiaries’ age. New-onset health issues do not lead to premium increases.
The catch is that if one initially enrolls in an MA plan and then decides to switch out more than a year later, Medigap insurers will take into account the individual’s pre-existing conditions, and may decline coverage or demand high premiums.
The newly revised Medicare Plan Finder tool does not explain this possibility. Nor does another CMS website, “Join, switch, or drop a Medicare Advantage plan.”
A third Medicare.gov website, “When can I buy Medigap?” is more specific, explaining in the third section that “there’s no guarantee that an insurance company will sell you a Medigap policy if you don’t meet the medical underwriting requirements,” meaning the Medigap issuer’s stance on pre-existing conditions.
Yet another Medicare publication does explain that if beneficiaries enroll in a Medicare Advantage plan at age 65 and want to get out, they must do so within 1 year, and then they have another 63 days from the disenrollment date to buy a Medigap plan without risk of coverage denial or being subject to underwriting.
Other Complaints
Besides MA’s lack of transparency on costs, critics also cite problems with insurers’ provider networks. The AMA wants CMS to make sure networks are adequate and list physicians, their specialties and subspecialties, and how many actually cared for plan members the prior year.
AMA spokesman Robert Mills (no relation to Tom Mills) referenced a Kaiser Family Foundation report that found 35% of plans studied were served by a “narrow” physician network, meaning that fewer than 30% of the physicians in that county were contracted.
“Plans may purposefully understaff specialties to avoid attracting enrollees with expensive pre-existing conditions like cancer and mental illness,” he said.
David Lipschutz, an attorney with the Center for Medicare Advocacy in Washington, D.C., also hears about limitations. “It’s a common scenario,” he said. “Often you have to jump through certain hoops or over certain barriers to access care, or it’s subject to prior authorization.”
His colleague, attorney Toby Edelman, has heard beneficiaries complain about plans that have two nursing homes in their network. “There are 50 in your area, but they have two and these are not the best.”
At California’s Health Insurance Counseling and Advocacy Program, San Diego manager David Weil hears horror stories too. “If they answer yes [on a questionnaire] to something the company doesn’t like, the company won’t sell them a policy. Almost anything can be on their list.”
Why do people want to switch? Weil described it as a “funnel effect, the feeling that you have to squeeze through an ever-closing hole in order to get services … Or you have to wait eight weeks to see a specialist. People get fed up with that.”
Last month, veteran consumer advocate Ralph Nader blasted MA plans as nothing more than a way to enrich health insurers at seniors’ expense. Calling the plans “Medicare Disadvantage” and a “corporate trap,” Nader took the AARP, which offers its brand of Medicare Advantage through UnitedHealthcare, to task for being asleep on the issue, and in conflict because it gets a 4.95% commission.
AARP spokesman Gregory Phillips responded: “AARP supports increasing access through guaranteed issue to Medigap coverage, in addition to eliminating medical underwriting and age rating, to ensure that older Americans will get the coverage they need when they need it most.”
And he agreed that many beneficiaries may not be aware that plans “may terminate their relationship with Medicare in any given year; change the premiums, cost-sharing charges, or benefits from year to year (including drug coverage); and drop physicians from their networks during the year.”
“Beneficiaries may also not be aware that if they want to voluntarily leave an MA plan and return to traditional fee-for-service Medicare, they may be subject to medical underwriting for a Medicare supplement (Medigap) policy. This underwriting may result in their being refused a policy or being required to pay higher rates.”
But Phillips defended AARP’s participation in MA, saying it provides information on both MA and traditional Medicare plans.

Atreca: FDA Clears Investigational New Drug Application for ATRC-101

First IND clearance of a clinical candidate derived from Atreca’s differentiated drug discovery platform
 Phase 1b clinical trial in patients with solid tumors to begin in early 2020
Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on the development of novel cancer therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application. Atreca expects to initiate a first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors in early 2020.
“The FDA’s clearance of our IND application for ATRC-101 is a significant milestone for Atreca and validates the ability of our differentiated drug discovery platform to generate novel clinical candidates against cancer,” said John Orwin, Chief Executive Officer. “We believe that ATRC-101, with both its unique target and mechanism of action, represents an exciting approach in oncology, and we look forward to the initiation of our Phase 1b clinical trial in early 2020.”
The Phase 1b trial will be an open-label, dose escalation, monotherapy trial with an adaptive 3+3 design and will enroll patients with a variety of solid tumor cancers, including ovarian, non-small cell lung, colorectal, breast and acral melanoma. The antigenic target of ATRC-101, a ribonucleoprotein complex, is expressed on over 50% of patient samples for each of these tumor types. Major objectives for the trial are to characterize the safety of ATRC-101 and determine a recommended dose for future studies. The trial will also evaluate potential biomarkers and the initial clinical activity of ATRC-101.

B of A Updates 2020 GE Healthcare Projections Following Investor Day

General Electric Company GE 0.72% held a GE Healthcare investor day event this week. One analyst in attendance said Tuesday that Healthcare should be a stable source of free cash flow for GE as it executes its turnaround strategy, but the GE bull case still hinges on Power.

The Analyst

Bank of America analyst Andrew Obin reiterated his Neutral rating and $12 price target for GE stock.

The Thesis

Obin listed three major takeaways from the event for investors:
  • Not including Biopharma, GE Healthcare should generate between $1.6 billion and $1.8 billion in free cash flow in 2020.
  • GE’s digital offerings have grown large enough to potentially help expand Healthcare margins.
  • There were no major surprises in GE’s Healthcare guidance of mid single-digit revenue growth and between 0.25% and 0.75% of margin expansion per year.
Including Biopharma, Obin projects $2.9 billion in 2020 free cash flow from GE Healthcare, down from $3 billion in 2018. He said Healthcare should be able to grow free cash flow in the high single digits starting in 2021.
“On balance, GE’s Power segment has more opportunity to drive either the Bull or Bear case,” Obin wrote in a note.
GE’s digital revenue is growing in the high single digits at margins of greater than 50%. Obin said the key risk to this growth is the potential for new competitor willing to sacrifice profits to gain market share.

Benzinga’s Take

The worst may finally be over for GE investors after years of market declines. However, GE will need to demonstrate it can generate sustainable cash flow and earnings growth to make the stock appealing to value investors.

MediWound launches mid-stage study of EscharEx in venous leg ulcers

MediWound (MDWD -1.2%initiates Phase 2 clinical trial evaluating EscharEx, a topical biologic designed to enzymatically debride (remove dead tissue) chronic wounds, for the treatment of venous leg ulcers.
The primary endpoint is the incidence of complete debridement within two weeks (up to eight applications of EscharEx).
Preliminary data should be available in about a year.

Adaptimmune gets boost from FDA as T-cell cancer drug wins inside track

Adaptimmune has been struggling as of late, losing its R&D chief during a CEO transition as its share price $ADAP steadily drifted down to alarming lows. But the struggling biotech got a much-needed boost today from the FDA, which put one of its top cancer drugs on the inside track reserved for drugs that qualify as a Regenerative Medicine Advanced Therapy.
RMAT — which extends to cell therapies — hasn’t received nearly as much attention as the FDA’s much cooler sounding breakthrough therapy designation, but it comes with much the same open-door invitation from the agency, an opportunity to discuss fast-tracking surrogate endpoints, and a chance to shoot ahead in gaining a marketing decision.
And Adaptimmune — now helmed by Adrian Rawcliffe, who stepped up to replace founding CEO James Noble — needs to prove itself. Shares are down 91% from last fall’s spike.
The RMAT designation goes to ADP-A2M4, one of the biotech’s top in-house TCR programs after they handed the lead — NY-ESO — to their partners at GlaxoSmithKline. They won the designation off of some very early-stage data in synovial sarcoma, where execs believe they can show clear headway in developing a T cell therapy for solid tumors. In this case, the drug targets MAGE-A4, a common antigen.
The biotech has only put out data on 14 patients, but there’s some promise there, with a 50% partial tumor response (confirmed as well as unconfirmed, it should be noted) in 7 of the patients. It’s now in Phase II, with a PD-1 combo approach being assembled on a parallel track, and Adaptimmune is promising to have this on the market as a groundbreaking new therapeutic approach in 2022.
Adaptimmune has won some cautious support from analysts on the data updates, with some concerns about this new drug’s ability to transcend various tumors apart from sarcoma. And the biotech has quite a mountain to climb. Its stock bumped up slightly Tuesday morning, with a 5% jump.