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Monday, November 4, 2019

Bellicum up 26% ahead of data presentation on CAR program

Nano cap Bellicum Pharmaceuticals (BLCM +26.2%) jumps on a 2.5x surge in volume, adding to its 30% move on Friday.
No particular news accounts for the action, but this Friday, November 8, an abstract on its natural killer cell chimeric antigen receptor (CAR) program will be presented at the SITC Annual Meeting in Maryland.
The company’s technology, GoCAR-T, is the basis for pipeline candidates BPX-601 and BPX-603.

Celsion down 12% on questions with ThermoDox survival data

The independent Data Monitoring Committee has unanimously recommended that a Phase 3 clinical trial, OPTIMA, evaluating Celsion’s (CLSN -11.8%) ThermoDox plus RFA (radiofrequency ablation) in hepatocellular carcinoma (primary liver cancer) patients continue as planned.
The data review showed that median progression-free survival (PFS) reached 17.3 months as of August, though this is a secondary endpoint.
Investors appear disappointed with the company’s statement on overall survival (OS), the primary endpoint, saying combined OS for both treatment arms is “consistent” with that observed in the Phase 3 HEAT study (which failed to show enough of a treatment benefit) subgroup of 285 participants who received at least 45 minutes of RFA therapy. In a February 2015 statement, the company said ThermoDox + RFA extended OS 59% compared to RFA alone in this population. At data cutoff in OPTIMA, though, median follow-up for survival was only 25 months, too early for estimates. Median follow-up in HEAT was 67 months.
The next data readout should happen in Q2 2020. The hazard ratio for success is 0.70 based on 158 patients deaths, below the ratio of 0.65 observed in the 285 patients cited above.

Halozyme bails on PEGPH20; to cut headcount 55%

Citing its intent to focus its resources on it ENHANZE drug delivery technology, Halozyme Therapeutics (HALO +1.1%) will terminate development of PEGPH20, shut down its oncology operations and cut 160 jobs representing ~55% of its workforce. Most (~80%) of the layoffs will be done by early January 2020.
Management says the restructuring and cost-saving initiatives should save $130M – 140M next year, adding that it expects to be “sustainably profitable” in Q2 2020.
The company will provide further details during its Q3 conference call on November 12.

SI-BONE up on enhanced reimbursement environment for iFuse

Thinly traded micro cap SI-BONE (SIBN +10.7%) is up average volume in response to an increase in Medicare’s Physician Fee Schedule for minimally invasive sacroiliac joint fusion procedures (CPT Code 27279), commonly performed with the company’s iFuse Implant System.
The change, effective January 1, 2020, raises the Work Relative Value Units (reflects the resources used to provide the service) associated with the Code to 12.13 from 9.03. The overall surgeon payment will go up to $915 from $720.

Meredith Health Brand Builds Momentum

On the heels of a successful editorial redesign, a rebounding advertising performance and a 50% increase in its unique visitors year-over-year, Meredith Corporation’s (NYSE: MDP; www.meredith.com) Health brand is poised for continued momentum across its multi-platform business with new hires and investment in the print product including an upgraded paper stock and increased trim size.
  • Brendan Smyth rejoins Health as its publisher. Smyth, former publisher of Family Circle, succeeds Maria Jakubek, who joined PEOPLE as Executive Director of Sales. Smyth, a Meredith veteran, has held senior sales roles at Better Homes & Gardens, Midwest Living, and other lifestyle brands.
  • Cheryl Brown is Health Magazine’s new Executive Editor. Brown, former Editor in Chief of Family Circle, reports to Health magazine Editor in Chief Amy Conway, effective immediately. Brown succeeds Bethany Heitman, who continues to collaborate with Health as Entertainment Editor at Large, working on its covers, cover stories, and other celebrity content. Previously, Brown was launch Editor-in-Chief of Health’s sister brand Allrecipes magazine and has extensive lifestyle editorial experience that makes her an ideal fit with Health.
  • Amber Brenza is newly appointed senior editor focused on Health.com‘s highly profitable condition content hubs that address more than 90 health conditions including digestive health, chronic disease, mental health, skin conditions, and reproductive health. Brenza is charged with enhancing the content in those highly-trafficked site sections and creating new content opportunities for Health’s audience. She joins us from Women’s Health. Additionally, Susan Brickell, a seasoned writer and market editor with experience at various lifestyle and wellness brands, was also appointed senior editor with a focus on commerce coverage. Brenza and Brickell report to Dara Kapoor, executive editor of Health.com, effective immediately.
  • Meredith is enhancing the magazine’s physical environment with an enhanced paper stock and a larger trim size currently used by Health’s sister brand SHAPE, with the March 2020 issue. These changes reflect the brand’s focus on creating a more engaging lean-back experience.
“With its solid foundation in trusted health journalism and pulse on our country’s booming interest in all things wellness, the Health brand is a considerable franchise that our executive team feels passionately about growing into an even more robust multi-platform business,” said Doug Olson, President, Meredith Magazines. “With increased investment, we believe Health will continue to strengthen its position in the marketplace as an even more relevant and widespread resource spanning legacy and emerging media channels to better serve our audience.”
The magazine’s ad revenue is up 7% YTD through the December issue (publisher’s estimate) with new advertisers from nearly every category from beauty and food to pharma and household supplies.
The brand’s digital footprint has grown 50% YOY (ComScore) to nearly 10 million unique visitors who are embracing Health’s content and engaging with the brand across all channels. Earlier this year, Health launched Balance by Health, a voice-activated Alexa skill and Facebook chatbot that delivers daily wellness inspiration and motivation with content from Health and sister brands SHAPE, EatingWell, and Cooking Light. This year Health also launched Wellness Warriors, a 360 brand platform that recognizes women innovating in the health and wellness industry as leaders, disruptors, scientists, and entrepreneurs.
Catherine Levene, President, Meredith Digital, said: “Health.com is one of our top brands. In fact, as of September, it’s the fourth largest site in Meredith’s digital network, and we see enormous potential in growing our online presence.”
On the experiential side, Health will partner with SHAPE for the first time to present the 16th-annual SHAPE-Health Women’s Half Marathon and 5.8 mile loop in New York’s Central Park on April 19, 2020. The brand also has a robust point-of-care business.

Genomic Health reported EPS beat of $0.10

Genomic Health (NASDAQ:GHDX): Q3 GAAP EPS of $0.48 beats by $0.10.
Revenue of $114.36M (+12.9% Y/Y) beats by $2.09M.
Reported on Oct. 30, 2019.

Omeros down 11% on lack of CMS non-opioid exclusion of Omidria

Omeros (OMER -11.2%) is down out of the gate this morning despite positive results from a prospective study that showed significantly less fentanyl use in cataract surgery patients receiving eye drop Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3%. The data were just published in the journal Clinical Ophthalmology.
The study compared Omidria to epinephrine on perioperative use of fentanyl. 9.8% of patients receiving Omidria required fentanyl versus 42.1% of those receiving epinephrine (p=0.006). In addition, mean visual analog scale (VAS) pain scores were also lower (2.3 vs. 4.5; p<0.0001).
Investors appear to be reacting to CMS’ final rule related to its outpatient prospective payment system (OPPS) for opioids and non-opioid alternatives for 2020 published on November 1 that did not include Omidria in the non-opioid exclusion from packaged payment.
The company says CMS had received an analysis of the data from the study beforehand but wanted to see peer-reviewed published evidence before considering Omidria for non-opioid exclusion.
Omidria qualifies for reimbursement through October 1, 2020 under its current pass-through extension.