Trellus Health Share Discussion Threads

[wan] 27/10/2021 09:25

A bit more detail regarding the above trial -

At Week 104, 75% of Patients with Ulcerative Colitis Taking Mirikizumab Maintained Symptomatic Remission in Phase 2 Study
October 1, 2021

INDIANAPOLIS, Oct. 1, 2021 /PRNewswire/ -- Patients taking mirikizumab for their moderately to severely active ulcerative colitis (UC), were in symptomatic remission for up to two years as demonstrated in new results from Eli Lilly and Company's (NYSE: LLY) Phase 2 study. Symptomatic remission is defined as no more than two bowel movements more than an individual's normal bowel frequency, and no blood in their stool.

"Millions of people around the world are living with ulcerative colitis, a chronic inflammatory bowel disease that affects the lining of the colon and causes abdominal pain, bowel urgency and frequency, and bloody stools. These symptoms can be unpredictable and severely disrupt a person's daily life, even making it hard for them to leave their home, go to work or see family and friends. We need therapies that provide long-term symptom control in order to give patients their lives back," said Remo Panaccione, M.D., University of Calgary, Inflammatory Bowel Disease Center, and lead author of this analysis. "These exciting Phase 2 results reinforce the potential for mirikizumab to provide that long-term, symptomatic remission from some of the most common and distressing symptoms of ulcerative colitis, specifically stool frequency and rectal bleeding."

In a separate, post-hoc analysis of patients treated with mirikizumab in this Phase 2 study, an absence of bowel urgency (the sudden or immediate need for a bowel movement) in patients with moderately to severely active UC at 12 weeks was strongly associated with reduced levels of inflammatory biomarkers, an indicator of disease activity. Both analyses will be presented virtually at United European Gastroenterology Week (UEG Week), taking place October 3-5, 2021.

Three Out of Four Patients Continuing Treatment with Mirikizumab Maintained Symptomatic Remission At Two Years

Post-Hoc Analysis Showed Relationship Between Patient-Reported Bowel Urgency and Inflammatory Biomarkers in UC

Patients who responded to mirikizumab at week 12 and reported no bowel urgency had significantly greater reductions from baseline measures in two inflammatory biomarkers, C-reactive protein (CRP) found in the blood and fecal calprotectin (fCLP) found in the stool, compared to patients who reported bowel urgency. Absence of bowel urgency was defined as no bowel urgency reported for three consecutive days prior to each scheduled visit, regardless of bowel urgency status at baseline. Levels of CRP and fCLP continued to decrease from 12 weeks to one year for both patient groups.

For methodology and additional results, see the "About the Analyses" section below.

"Results from this analysis suggest that among patients with ulcerative colitis treated with mirikizumab, the absence of bowel urgency may be associated with reduced levels of inflammatory biomarkers, which are important indicators of disease severity," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development and U.S. and global medical affairs at Lilly. "Taken together, we are excited to share at UEG Week a range of data that showed mirikizumab, if approved, may potentially be the first anti-IL-23p19 therapy that reduces disease activity and offers remission from the debilitating symptoms of stool frequency and rectal bleeding for patients with moderately to severely active ulcerative colitis."

Mirikizumab is currently being studied in Phase 3 trials for UC and Crohn's disease.

Full release -

Recall that Trellus is already in discussions with pharma

[wan] 27/10/2021 07:52

Very interesting, especially regarding biomarkers.

Scroll down to read about the trial and watch video interview of Trellus Co-Founder Marla C. Dubinsky, MD: Measuring Urgency in Ulcerative Colitis
October 27, 2021
Kenny Walter

The absence of urgency could be a useful metric in gauging colonic inflammation in patients with ulcerative colitis.

In data presented during the 2021 American College of Gastroenterology (ACG) Annual Meeting, a team led by Marla C. Dubinsky, MD, Professor of Pediatrics, Icahn School of Medicine at Mount Sinai, found patients with the absence of urgency had significantly greater reductions in levels of inflammatory biomarkers C-reactive protein (CRP) and fecal calprotectin (fCLP) in a cohort of patients treated with mirikizumab.

In the study, 249 patients were equally randomized to receive intravenous placebo, 50 or 200 mg mirikizumab with exposure-based dose increase possibility or fixed mirikizumab 600 mg every 4 weeks.

Full article and interview -

American College of Gastroenterology
Annual Scientific Meeting & Postgraduate Course
The Premier GI Clinical Meeting
October 22-27, 2021

[wan] 22/10/2021 09:26

Mount Sinai is both a partner and significant investor (25%) in Trellus Health.

Press Release
Mount Sinai Leader Awarded 2021 Sherman Prize for Advancements in Understanding IBD Genetics

New York, NY (October 21, 2021) The Bruce and Cynthia Sherman Charitable Foundation has announced Judy H. Cho, MD, Dean of Translational Genetics and Director of The Charles Bronfman Institute for Personalized Medicine at the Icahn School of Medicine at Mount Sinai, as a recipient of the 2021 Sherman Prize, which recognizes excellence in the field of Crohn’s disease and ulcerative colitis, two forms of inflammatory bowel disease (IBD).

Dr. Cho was awarded a $100,000 Sherman Prize for her pioneering genetics research that has advanced understanding of the underlying causes of IBD and paved the way for personalized treatment approaches. A leader of the team that identified the first gene for Crohn’s disease, NOD2, Dr. Cho has contributed to virtually every major discovery in IBD genetics over the past 20 years.

Dr. Cho’s work explores how to prioritize new therapeutic targets and tailor biologic agents for individual patients who don’t respond to current therapies. Her research on the involvement of the protein IL-23 in the disease cascade led to anti-IL-23 therapies that are widely used to treat Crohn’s disease and ulcerative colitis. Now she’s exploring new targets and combination therapies and supporting junior colleagues in their research to help ensure the work continues. Her hope for the future is that with greater understanding of the genetics of these diseases, gene therapies will be made possible—putting the potential for true cures within reach for even the most severe forms of disease.

Dr. Cho joined the Icahn Mount Sinai faculty in 2013, following appointments at the Yale University School of Medicine and the University of Chicago Pritzker School of Medicine. She earned her MD at The Ohio State University College of Medicine, and completed both a residency in Internal Medicine and postdoctoral research training at Northwestern University Feinberg School of Medicine.


For further interest, there are numerous examples of co-authored publications/work involving both Judy H. Cho, MD, and Trellus Health co-Founder Marla C. Dubinsky, MD. For example, the identification of novel blood protein biomarkers associated with future Crohn’s disease complications.

[pldazzle] 19/10/2021 09:22

Rivaldo #136 - What your tax adviser writes is not, in fact, inconsistent with note 30 to EKF's accounts. Trellus had not floated at the date of the distribution in Dec 2020 (it did so only in May 2021) and hence the fair value at the date of distribution was deemed by EKF's auditors to be the same as the value at the date of EKF's acquisition a few months earlier, in August 2020. In this context, there is no difference for practical purposes between "fair value" and "market value". In my view it would clearly offend against proportionality for HMRC to argue the toss on this.

JakNife - s1075 CTA 2010 references ss1076, 1077 and 1078. The last two are not relevant here: s1076 is about in-specie distributions of >75% subsidiaries. I don't think Trellus was ever a subsidiary of EKF, and I don't think s1075 applies here.

Edit: If still in doubt, I suggest you seek confirmation from the EKF company secretary. In my experience he has responded helpfully in the past.

[rivaldo] 18/10/2021 14:55

Many thanks for your replies. However....my tax adviser has replied as follows (I've changed the numbers to continue the example above):

"It is my understanding that you still hold 100,000 shares in EKF Diagnostics PLC. You received 6,154 shares in Trellus Health PLC as dividend in specie from EKF Diagnostics PLC. Therefore, the market value of Trellus shares on the date of the distribution should be the dividend income reportable on the tax return."

Has anyone submitted their 2020/21 tax returns to HMRC yet or agreed the divi in specie calculations with your accountants or tax advisors?

[pldazzle] 12/10/2021 17:23

james - you beat me to it. Rivaldo, I confirm that I agree with james and that the formula is (in your illustration) 100,000 x £0.008374 i.e £837.40.

[james188] 12/10/2021 16:37

The fair value figure is for each EKF share (not Trellus), so that is the dividend value to focus on in working out the relevant distribution, rather than the number of Trellus shares granted. So the dividend figure in your example would be £837.40.

[rivaldo] 12/10/2021 16:07

Many thanks for the replies. Pldazzle, I'm still a little unsure TBH. So a practical example....

Say you own 100,000 EKF shares. Then the in-specie distribution according to my tax adviser would be 100,000/16.25 x £0.8374, i.e £5,153.23.....whereas you're saying it would be 100,000 x £0.008374 i.e £837.4, i.e ignoring the one share for every 16.25 held allocation. Correct?

[pldazzle] 11/10/2021 19:17

sharw - No, it's specifically a dividend in specie (see quote above) and taxable as such: it's not treated as, nor deemed to be, a return of capital.

[sharw] 11/10/2021 18:31

But as it was existing as an investment of EKF rather than cash is this regarded as a dividend or as a return of capital for tax purposes?

[pldazzle] 11/10/2021 15:10

rivaldo - No, it's 0.8374p (or to put it another way, £0.008374) per EKF share held. See Note 30 to EKF's 2020 accounts:

"In August 2020 the Company invested $5,000,000 (£3,810,000) for a 31.1% shareholding in Trellus Health Limited, a pioneer in resilience-driven care for people with complex chronic conditions. In December 2020 the Company made a distribution in specie whereby, with the exception of a single “golden” share, the Company’s shareholding in Trellus Health Limited was distributed to ordinary shareholders of the Company at a total value of £3,810,000. The fair value per EKF share was 0.8374p. In view of the acquisition and disposal occurring in the same financial period, the Group has not applied equity accounting to this investment, but instead has valued the dividend at cost."

[rivaldo] 11/10/2021 15:01

It's 2020/21 Tax Return time (yay!). My tax adviser has calculated the Trellus dividend in specie received from EKF as follows for each EKF share : 1 EKF share/16.25 x £0.8374p, i.e roughly 5.15p per EKF share held. Does everyone agree this?

[wan] 23/9/2021 07:56

Good presentation yesterday, reiterating the confidence regarding further contracts/commercialisation and scale-up in the the near-term, and confirmation that Trellus is 'already' in discussions with pharma.

[mikemine1] 22/9/2021 10:09

No surprises. Hitting milestones and further progress expected in the coming months. Well funded and losses very well covered. Difficult to say how well Trellus will do as their offering is pretty unique at the moment. Could easily boom but we need patience right now.

[brummy_git] 22/9/2021 08:04

How are things progressing at Trellus Health?

A pioneering deep science based telemedicine firm, focused initially on treating IBD such as Crohns & colitis?

Find out all the news & commentary here after today's interims.

www.linkedin.com/posts/paul-hill-a5994116_trls-activity-6846335114125864960-nCVi

[wan] 22/9/2021 07:46

Results as expected. The attached commentary however is very optimistic and encouraging regarding scale-up and commercialisation.

From where I am standing based on my own research etc, and indeed the Chairman's Statement, it lends further weight to my view that at least one strategic industry partnership might come sooner than perhaps some think. Especially if you also factor in the potential utility across many chronic conditions, which is something that originally caught my attention.

[brummy_git] 17/9/2021 15:44

Great update interview here on Trellus

Hit the bottom of the 2 'red play' buttons

www.voxmarkets.co.uk/articles/stocks-to-follow-with-justin-waite-and-paul-hill-7c37ed7

[brummy_git] 16/9/2021 08:09

Marvellous new 'white label' & highly scalable contract announced today by Trellus Health with New York healthcare provider Connected Health Medicine.

All the commentary here.

www.linkedin.com/posts/paul-hill-a5994116_trls-activity-6844163621367414784-F_4i

[wan] 09/9/2021 15:13

I note the Results and Presentation date, but most readers (including me) will not be able to access the conference call for the Analysts Briefing, as it is only available to healthcare analysts.

Time will tell what the analysts think, but one might also assume there is more to tell than the maiden interim results alone convey.

[wan] 09/9/2021 08:37

Management of chronic conditions and behavioural health cited as an area of telehealth expansion -

Hospital telehealth leveling off at one-fifth of medical appointments, research finds
Published Sept. 8, 2021

Rebecca Pifer
Reporter

Dive Brief:
The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.

More than 80% of hospital executive respondents to the survey fielded in May and June this year said one-fifth or fewer of their facility's appointments were being conducted virtually. Of the hospitals and health systems reporting 30% or more of their volume is virtual, many said they expected that percentage to decline over the long term as the pandemic wanes in the U.S.

Despite use of telehealth dwindling from last year's peak, many provider organizations say they're looking to expand their virtual care services to better manage patient populations while keeping costs down. The top three areas for future telehealth expansion cited by survey respondents were chronic care management, behavioral health and urgent care.

Dive Insight:
The pandemic resulted in a historic increase in telehealth use last year, as providers quickly pivoted to handling non-emergent visits virtually to recoup lost in-person volume. According to data from EHR provider Epic, telehealth made up almost 70% of all ambulatory visits by mid-April of 2020. Before the pandemic, they made up fewer than 0.01%.

However, telehealth utilization has oscillated since its peak, generally linked to rising and falling COVID-19 cases, experts say. In 2021, usage has more or less fallen off with the reopening of doctor's offices and hospitals and widespread vaccination efforts, though its unclear how the recent resurgence in cases tied to the highly infectious delta variant may have affected virtual visits.

There's a general consensus in the industry that telehealth utilization will never go back to its low pre-pandemic levels, but market watchers are curious where it will level off. That will have huge repercussions for the sustainability of the recent telehealth boom.

Full story, worth reading -

[wan] 08/9/2021 07:59

Above post edited to include more of the story.

[wan] 08/9/2021 07:28

In broader healthcare news, and as healthcare transitions to a new model of care -

Amazon looks to bring telehealth, in-person care to 20 more cities.
It will soon offer the "full package" of hybrid virtual/in-person care in Philadelphia, Chicago, Dallas and Boston, Insider reports, with more expansion to follow in 2022.

By
Kat Jercich
September 07, 2021

Amazon is reportedly looking to launch its app-based home visits in 20 major U.S. cities through 2022.

According to Insider's Blake Dodge, Amazon Care will bring the "full package" of telehealth and in-person services to Philadelphia, Chicago, Dallas and Boston in 2021, with 16 more to follow the next year.

Amazon representatives told Healthcare IT News after publication that the company does not comment on rumors or speculation.

WHY IT MATTERS

Amazon Care has grown rapidly since it was first offered exclusively to the tech giant's Seattle-based employees in 2019.

This past September, Amazon announced it would allow employees to access the app-based care throughout Washington state. It then made services available to other employers in the state before officially expanding its telehealth option to employers in all 50 states this summer.

But its in-person services, which include follow-up blood draws and exams, have been limited so far to users in D.C. and Baltimore, as well as in Washington state.

Now, reports Dodge, Amazon plans to offer in-person options in Atlanta, Denver, Detroit, Houston, Indianapolis, Kansas City, Los Angeles, Miami, Minneapolis, Nashville, New York, Phoenix, Pittsburgh, San Francisco, San Jose and St. Louis in 2022.

That would bring the total number of cities up to 22, in addition to the entirety of Washington state.

Dodge also notes that Amazon has been attempting to make inroads at health plans, which would open up the service to insured people in addition to employer clients.

THE LARGER TREND

In June, an Amazon exec said it had signed several companies to the company's telehealth service.

At the time, VP Babak Parviz said the company is planning to make the "hybrid" virtual/in-person service available in additional regions "as fast as we can."

Amazon also made waves in July with news of its at-home COVID-19 testing kit, which can be purchased for $39.99.

Full story -

Amazon's healthcare website has been updated accordingly -

Experience a new kind of healthcare
Amazon Care is healthcare built around you, your life, and your schedule.

[wan] 03/9/2021 09:46

I should have highlighted in the above, that Laurie Keefer, PhD. is a
co-founder of Trellus Health.