Revenue guidance stillok until mid 2024!
'Operational highlights (including post-period end)
· Initial revenues following the commercial launch of our first product, Tutivia™, the Company's post-transplant prognostic test for the assessment of risk of acute kidney rejection.
o Full year revenues from Tutivia™ are likely to be less than expected although the Company has recently doubled the number of US transplant centers as early adopters of the test.
· The impact of lower Tutivia revenues is expected to be offset by higher than expected research-related revenues so that that cash runway expectations to mid-2024 are unchanged at this time.
· Successful clinical validation of our second product, Clarava™, the Company's pre-transplant prognostic test, demonstrating a statistically significant result and capability to stratify patients based on their likely immune response to a transplanted kidney, informing a clear, actional response for clinicians.
o Clarava™ is on track for initial US commercial use by the end of 2023 under prospective real-world evidence studies.
· Completed patient enrolment for the multi-centre clinical validation study of the Company's third product, Protega™, assessing long-term outcomes for kidney transplant patients.
· Received preliminary gapfill median rate of $2,650 proposed for both Clarava™ and Tutivia™ by the Centers for Medicare & Medicaid Services ("CMS"). These rates are due to be finalised later this year and represent a substantial uplift from the Company's initial assumption for modelling purposes.
· Two key patents granted in the United States underpinning Verici Dx's products.
· Achieved CLIA Certificate of Compliance for clinical laboratory in Nashville, TN, USA, a key requirement to obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial launch of Tutivia™ in 49 out of 50 US states to date.
· Submitted final responses to comments for our peer-reviewed publication on the Tutivia clinical validation. Final publication dependent on publishers.
· Initiated studies in our databank to facilitate product development and further research collaborations.
· Obtained Medicaid approvals in 15 States and a further 12 States pending.
Outstanding clinician feedback on Tutivia™
We have been delighted with the feedback on Tutivia™ following its commercial launch at the start of 2023.
"In the first few months post-transplant there are many rejection events and yet in my opinion we have not really had a biomarker that can assist at this critical time. Tutivia™ is able to give the clinician reliable test results as soon as the first week post-transplant and so is an early biomarker test which addresses this critical need."
Dr Nicolae Leca Professor, Medical Director, Kidney and Pancreas Transplant - University of Washington
My comfort lies in the fact that the mcap at 1.7m doesn't even reflect the M2G business value!
RP was buying shed loads at 13p
City oil at advanced stages
100k is nowt in the scheme of things and RP just tidying up the books.
We are due some sort of substantial update very soon.
GL.
Agree 100k is nowt in the scheme of things and they keep the licensing aspect.
Also they are not asking us for funding.
Perhaps this is the start of a hectic news period.
GL.
And as ever any sort of rise is sold into in nice round clumps until we are back where we started!
Does anyone have an idea :
1) Who is selling each time?
2) Where they are getting their shares from?
3) Why they would want to stifle the SP?
It's like groundhog day here!
GL.
Is the fat lady clearing her throat?!
GL.
Just coz I don't post doesn't mean I don't read!
You all need therapy imho.
Oh and PP1 I know whom is emotionally attached to this BB.
He said she said pathetic.
Note sometimes posting nothing speaks louder than a 1000 posts.
GL.
( you all need it)
Are we due an M2G quarterly update?
Richard shud be back from his jollies so lets hope for a raft of news!
GL.